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Monday, November 12, 2007

Long-term beta carotene use may help aging brains, study suggests

By Elizabeth Cooney, Globe Correspondent

Older men in good health who took beta carotene for about 18 years had better memory skills than similar men who took a placebo for the same length of time, a Harvard study shows.

The antioxidant, found in carrots, showed no benefit when taken for only three years, pointing to long duration as a critical factor in possibly slowing cognitive decline, which is a strong predictor of dementia.

The improvement was modest: Brain aging was delayed by about a year in men who took beta carotene long-term, author Francine Grodstein of Brigham and Women’s Hospital said in an interview. The study appears in today’s Archives of Internal Medicine.

She cautioned that it was too soon to recommend that men take beta carotene supplements. Beta carotene also has risks: Previous research has connected beta carotene to increased rates of lung cancer in smokers.

“Even though the changes that we saw are relatively modest, it is known that even modest changes in your memory can have a pretty big impact on the risk of dementia over the long term,” Grodstein, an associate professor of medicine at Harvard Medical School, said. It's the first study, she added, to find something that may help healthy people's memory.

The study followed about 6,000 men enrolled in the Physicians’ Health Study II over two time periods. They were given either 50 milligram pills of beta carotene or a placebo every other day. The first group participated for an average of 18 years and the second group for up to three years. They took tests of memory over the phone.

There was no improvement in the men who took beta carotene for the shorter time. The men who were on long-term beta carotene treatment did better, showing delays in cognitive aging of one to one and a half years, the study says.

In an accompanying editorial, Dr. Kristine Yaffe of the University of California, San Francisco, says it's plausible that long-term treatment may be necessary to have an effect on a disease that takes a long time to develop. But she also suggests there may be other interpretations of the results. In particular, she notes that the study doesn’t consider whether the men who took beta carotene for 18 years, staying in the study until it's completion, might be somehow different from men who did not continue to participate in the trial.

“For the clinician, there is no convincing justification to recommend the use of antioxidant dietary supplements to maintain cognitive performance in cognitively normal adults or in those with mild cognitive impairment,” she writes.

Grodstein said being conservative is appropriate.

“We don’t want to tell people to run out and start taking it immediately,” she said. “If we keep doing the research and keep working at it, it should give people hope we are going to be able to find something to help them keep their memory.”

Posted by Elizabeth Cooney at 05:01 PM

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Overweight men with prostate cancer have a higher risk of dying

Men who are overweight when they have locally advanced prostate cancer have almost double the risk of dying from the disease compared with men of normal weight, new research says.

The study, led by a team at Massachusetts General Hospital, is the first to find that excess weight alone is associated with deaths in men whose tumors had grown beyond the prostate or spread to lymph nodes, according to the study, which appears in the journal Cancer.

"The prevalence of overweight and obesity continues to increase in United States, so it’s an issue that's perhaps more important than ever," author Dr. Matthew R. Smith said in an interview. "What we need to do from here are additional studies to understand the mechanisms by which overweight and obesity are associated with worse prostate cancer mortality."

For men with a normal body mass index of 25, the death rate from prostate cancer was 6.5 percent after eight years. For overweight men, with a BMI between 25 and 30, it was 13.1 percent, and for obese men, with a BMI over 30, the death rate was 12.2 percent.

Obesity is not a new suspect in prostate cancer. Previous work has linked being overweight to having more aggressive forms of the cancer and higher rates of recurrence after radiation and surgery to remove the prostate gland. But other potential reasons for the difference in outcomes, from difficulty examining obese patients to possible biases in screenings, had not been isolated in the observational studies.

The study reported in Cancer analyzed data from a large randomized trial originally conducted to study radiation and hormone therapy in about 900 men with prostate cancer. That means the men had similar disease characteristics to be included in the trial. The authors, who also include researchers from Fox Chase Cancer Center and UCLA, looked at the men's BMI at the start of the trial and what happened to them over about eight years of follow-up.

Dr. Oliver Sartor of Dana-Farber Cancer Institute said the researchers have made an important observation from a well-designed trial.

"Now the hypothesis-driven question to ask is whether or not weight loss after diagnosis with prostate cancer will lead to better outcomes," he said in an interview. "That's an important question."

Posted by Elizabeth Cooney at 07:00 AM

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Friday, November 9, 2007

Open access, open debate

Making scientific articles free and available to all is only fair to the taxpayers who support research and the developing countries who need it, a Nobel laureate at the forefront of the open-access movement said at a forum today, but the editor of a prestigious journal likened that approach to vanity publishing.

Dr. Harold Varmus, head of Memorial Sloan-Kettering Cancer Center and former director of the National Institutes of Health, and Emilie Marcus, executive editor of Cell Press, took opposing positions at a conference on scientific publishing organized by graduate students at Harvard Medical School.

"The public pays a lot for the research that's published in this country," said Varmus, the keynote speaker. He shared the 1989 Nobel in medicine for his work with genes that cause cancer. "Why should they have to pay for it twice to see the results?"

During a later panel discussion, Marcus countered that having scientists pay journals to publish their work, which is the way open-access journals offset costs traditionally borne by subscribers, ignores the value that journals and editors bring.

"When journals derive money from readership, the pressure is on the journal to provide value important to the people who read it. I as editor focus on creating a journal you as readers want to read," she said. "The philosophy of publishing with the author paying can turn publishing into a vanity publishing model."

In opening remarks, Dr. Steven Hyman, provost of Harvard University, reminded the mostly young crowd of about 120 that when he was a student, he had to scramble to feed nickels into Xerox machines to copy papers from bound volumes of journals in the stacks of Countway Library.

Now scientists have the opportunity to make their work freely and immediately available online, with the same peer-review process in place, Varmus said. They pay a fee of up to $3,000 for publication in journals of the Public Library of Science.

Varmus also hopes for an encyclopedic and timely repository of all research, whatever journal publishes it originally, so people can search for all sorts of information without having to pay for it -- a concern for poorer nations around the world. PubMed Central was formed in 1999 with that idea in mind when Varmus was near the end of his tenure at NIH, but with only 5 percent of NIH-funded researchers contributing to it, and only several months after publication, the repository falls short of that goal, he said.

Marcus said articles published by Cell's parent company, Elsevier, are deposited on behalf of all NIH-funded authors into PubMed Central 12 months after publication at no charge.

Posted by Elizabeth Cooney at 07:24 PM

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Tuesday, October 30, 2007

One in eight veterans under 65 is uninsured, study finds

By Elizabeth Cooney, Globe Correspondent

Most Americans might think that veterans automatically have healthcare from the government, but one in eight working-age veterans is uninsured, a study from Cambridge Health Alliance reports.

Healthcare at Veterans Health Administration hospitals and clinics is limited to veterans who have service-related conditions or who have incomes of less than about $30,000 a year, depending on where they live. That leaves many middle-income veterans under 65 without coverage of any kind, mirroring the situation of other uninsured groups, Dr. Steffie Woolhandler, author of the study in the American Journal of Public Health, said in an interview.

“I and I think a majority of Americans had assumed that all veterans were automatically eligible for healthcare, and this in fact was true in the late 1990s,” she said. Now “the majority of middle-income veterans are excluded.”

A 1996 law opened VA care to all veterans, with a $50 co-pay for those were not classified as poor. But in 2002, regional directors were told not to market enrollment to new veterans because demand was exceeding resources, according to a department memo quoted in the journal article. Then in 2003, enrollment was halted for most veterans without qualifying medical conditions or incomes.

Using government data, Woolhandler and her co-authors found 1.8 million veterans who were uninsured and not receiving VA care in 2004, the most recent year available. That represented an increase of 290,000 since 2000. They also identified 3.8 million family members of those veterans who also had no health insurance. Together they account for 12.2 percent of the 47 million uninsured people in the United States.

“This really epitomizes the uninsured in the United States. They are working-age families earning too little to be able to afford to buy health insurance but too much to qualify for Medicaid,” she said.

The typical uninsured veteran is a 45-year-old man who has worked in the past year and is earning from $30,000 to $40,000 a year, Woolhandler said.

“Our soldiers serve so we don’t have to. They’re serving and protecting us,” she said. “They’re holding up their part of the bargain and when they come home, we’re really saying we as a society don’t have any obligation to serve and protect them by providing healthcare.”

Posted by Elizabeth Cooney at 05:13 PM

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Specialist referrals for imaging vary with who does the test, Mass. General study says

Doctors who send their patients for imaging tests to someone in their own specialty order diagnostic imaging more frequently than doctors who refer their patients to radiologists, Boston researchers report.

The reason for the difference may be financial, radiologist Dr. G. Scott Gazelle of Massachusetts General Hospital said in an interview about his article in the November issue of Radiology.

But that's impossible to know from the study's results, Dr. Nicholas DiNubile, a spokesman for the American Academy of Orthopedic Surgeons, responded in an interview, saying numbers of MRIs, CT scans, and X-rays alone can't determine whether they are ordered too often or not enough.

Looking at a national database of outpatient visits for such conditions as heart problems, broken bones, joint pain or suspected stroke, Gazelle and his team from the Institute for Technology Assessment at Mass. General found that physicians ordered imaging tests up to twice as often if they referred patients to doctors in their own specialty such as cardiology, orthopedics or neurology, compared with doctors who sent their patients to radiologists.

Previous research has indicated that doctors may order more scans when referring patients to a facility they own, but the authors of the new study decided to look at same-specialty referrals overall, rather than only referrals doctors made to imaging facilities they own. Gazelle said the authors made that choice in light of laws intended to curb self-referral that restrict some Medicare payments to doctors who refer patients to themselves.

"People are much more clever about it now," said Gazelle, who is on the board of chancellors of the American College of Radiology. "Same-specialty referral is in my view a proxy for self-referral."

All imaging has grown rapidly over recent years, but imaging done by non-radiologists has grown faster than imaging by radiologists, the study notes.

"I don't have a problem if a cardiologist or an orthopedist interprets imaging studies if they are qualified and do a good job," Gazelle said. "I do have a problem with the financial motivation to overuse it."

DiNubile, a knee specialist in Havertown, Penn., whose 25-surgeon group has its own imaging center staffed by a radiologist, said there is a turf war between specialists and radiologists who want to get back their business. He faults the study for not saying who owned the imaging facility where patients are being sent.

"The real question is whether that increases referrals when the physician owns his own shop," he said.

A better way to evaluate utilization rates would be to examine the imaging tests themselves to see if they were ordered appropriately, DiNubile said. Too many normal readings would suggest that too many tests are being ordered, for example.

"You always want to be sure to do the right thing," DiNubile said. "Is the right thing more utilization or less?"

Gazelle said the study was not intended to measure the quality of the imaging tests.

"The issue is we are using societal resources to pay for healthcare," he said. "We all ought to be ordering studies for the same reason."

Posted by Elizabeth Cooney at 01:39 PM

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Wednesday, October 24, 2007

MGH to study fish oil compounds as treatment for depression

Two compounds in fish oil will be tested as treatments for depression by researchers in Boston and Los Angeles.

Massachusetts General Hospital in Boston and Cedars-Sinai Medical Center in Los Angeles are recruiting volunteers for a randomized clinical trial that will compare two omega-3 fatty acids, DHA and EPA, against each other and against inactive pills in 300 adults who have major depression, the hospitals said. To be eligible, participants must not be taking anti-depressant medications, principal investigator Dr. David Mischoulon of Mass. General said in an e-mail interview.

Previous studies have suggested that the fatty acids, which are found in salmon, mackerel and tuna, might help reverse depression by affecting brain processes involved in regulating mood. The compounds have not been systematically tested before.

In this five-year trial, participants and researchers will not know who is taking an omega-3 supplement and who is not. People will be enrolled in the trial for eight weeks, after which they will be eligible for three months of free follow-up care from a physician in the study.

To learn more about the study, which is funded by the National Institutes of Health, call Mass. General’s Depression Clinical and Research Program at (877) 552-5837 or Cedars-Sinai at (888) 233-2773.

Posted by Elizabeth Cooney at 11:28 AM

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Monday, October 22, 2007

Notables

David H. Koch, an MIT alum and prostate cancer survivor who earlier this month pledged $100 million to build a new cancer research center at MIT, will donate $5 million to the Prostate Cancer Foundation for an initiative using nanotechnology. Four research institutions will collaborate on ways to use the technique, in which tiny particles are designed to attack tumors but spare normal cells, according to the foundation. Dr. Omid Farokhzad of Brigham and Women's Hospital is the principal investigator, Robert Langer of MIT will lead engineering and manufacturing for the project, Dr. Philip Kantoff of the Dana-Farber/Harvard Cancer Center Prostate Cancer Program will head clinical research, and Dr. Neil Bander, an antibody expert, will direct a group from the Weill Cornell Medical College.

Dr. Jonathan Winickoff of the MassGeneral Hospital for Children has won a $4 million grant from the National Institutes of Health to conduct a trial to help protect children from second-hand smoke by encouraging their parents to quit smoking. The study is based on a pilot program that targeted parents in their children's pediatrician's office. Fifty pediatric practices are being recruited through the American Academy of Pediatrics' Pediatric Research in Office Settings network.

Dr. Jeffrey Flier, dean of Harvard Medical School, and Lita Nelsen, director of MIT's Technology Licensing Office, have been named 2007 Biomedical Research Leaders by the Massachusetts Society for Medical Research. Flier was honored for his commitment to diabetes and obesity research and medical education, according to the nonprofit society, whose members include universities, hospitals, research institutes, and biotech and pharmaceutical companies. Nelsen was recognized for managing 500 new inventions per year from MIT, the Whitehead Institute and Lincoln Laboratory.

Dr. Joseph Vacanti, chief of surgery at the MassGeneral Hospital for Children, has won the 2007 John Scott Award for his work in tissue engineering. Since 1834, the awards, administered by a board acting for the city of Philadelphia, have recognized inventions that contribute to mankind's "comfort, welfare and happiness," according to the board. Vacanti's work combines engineering and biology to develop substitutes to help tissue or organs function. He shares this year's prize with Dr. Albert J. Stunkard of the University of Pennsylvania School of Medicine, who is being honored for his work to understand and treat eating disorders.

Posted by Elizabeth Cooney at 05:50 PM

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Tuesday, October 16, 2007

Ties between industry and medical schools widespread, survey finds

Almost two-thirds of the people leading medical school departments have personal relationships with industry and two-thirds of these departments have similar ties, a survey of 140 medical schools and top-funded teaching hospitals found. Most of the doctors polled said their relationships had no effect on their decisions, but they thought multiple conflicts of others could lead to biased research.

"When you say 'everyone's doing it,' the accumulation of data suggests that's really true," Eric G. Campbell, associate professor of health policy at the Massachusetts General Hospital Institute for Health Policy, said in an interview. He is the lead author of the study appearing in tomorrow's Journal of the American Medical Association. "There is virtually no aspect of medical education in which drug companies don't have significant relationships."

Campbell said the study gives the first portrayal of the links between companies and medical schools on the department level. The authors sampled departments of medicine, psychiatry, microbiology and one other nonclinical department at each surveyed institution.

They asked the individual chairs if they had served on company boards or speakers bureaus, been a paid consultant, or received compensation in the form of stock options, travel subsidies or honoraria. For departments, the questions were whether they got unrestricted funds, support for graduate students, or money for holding research seminars. They were asked if discretionary funds from industry paid for food and beverage, travel to meetings, journal subscriptions, software, or research or clinical equipment.

When asked about other chairs' involvement with companies, almost three-quarters of the respondents thought having more than one substantial role, such as being a consultant and a board member, would harm the department's ability to conduct independent research.

"Failure to address the existence and influence of industry relationships with academic institutions could endanger the trust of the public in US medical schools and teaching hospitals," the authors concluded.

Posted by Elizabeth Cooney at 04:00 PM

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Thursday, October 11, 2007

Boston-Denver team to lead study of COPD

A team of researchers from Boston and Denver will lead a large study of genetic factors and biological mechanisms involved in progressive lung diseases.

Brigham and Women's Hospital in Boston and National Jewish Medical and Research Center in Denver are the lead sites for the five-year, 16-center study of chronic obstructive pulmonary disease, which includes emphysema and chronic bronchitis. The two hospitals have received $37 million from the National Heart, Lung, and Blood Institute.

The researchers hope to enroll 10,500 participants, including 3,500 African-Americans. COPD is rising among African-Americans but risk factors in this population have not been adequately studied, according to the two hospitals' news release.

The Harvard School of Public Health, working with Johns Hopkins University, Brigham and Women's and the University of Colorado, will provide statistical analysis.

Posted by Elizabeth Cooney at 02:20 PM

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Wednesday, October 10, 2007

Children get recommended care less than half the time

Children get recommended care from their doctors less than half the time, leaving them even worse off than adults, concludes an analysis of medical care in 12 cities including Boston.

Researchers from the University of Washington, RAND and UCLA reviewed the medical records of more than 1,500 children and evaluated the quality of care they got as outpatients. They chose 175 quality indicators, from prescribing asthma medications to immunizing against childhood diseases to screening for sexually transmitted diseases.

To measure quailty, they divided the number of times the children's charts showed that recommended care was ordered or given by the number of times the care was warranted, based on national guidelines for screening, diagnosis, treatment and follow-up.

Overall, children received recommended care 46.5 percent of the time, they write in tomorrow's New England Journal of Medicine. That compares with a rate of 54.9 percent for adults.

When children had acute medical problems, they got the right services 67.6 percent of the time. For chronic conditions, they were given the indicated care 53.4 percent of the time. That falls to 40.7 percent for preventive care.

The authors note that research and policy devoted to children have concentrated more on expanding access to healthcare for children than on providing the right care.

"Deficits in the delivery of care must be identified if appropriate strategies to close the gaps are to be developed and implemented," they write.

Dr. James M. Perrin and Dr. Charles J. Homer of Harvard Medical School called the findings "shocking," while pointing out the study's limitations. Some of the data are 10 years old and failures in keeping accurate medical records may be a factor in the "dismal story," they write in an accompanying editorial.

"Services are not delivered when they should be, or they are delivered when they should not be," Perrin and Homer say in their editorial, also in tomorrow's journal. "Although one could challenge the precise 46.5 percent value for the percentage of overall care delivered, one cannot avoid the main observation that there exists a yawning chasm in the quality of health care provided to children."

Posted by Elizabeth Cooney at 06:45 PM

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Wednesday, October 3, 2007

Researchers gain access to Framingham Heart Study data

Three generations of Framingham Heart Study participants have shared their medical information with researchers learning about cardiovascular disease. Now the landmark study's files will be opened to scientists around the world so they can explore the links between genes and disease.

Framingham is the first study in an open-access project launched by the National Heart, Lung, and Blood Institute. The data come from more than 9,300 Framingham participants who had their DNA tested for 550,000 genetic variations. Researchers will have free access to that genetic information as well as clinical and laboratory test results. Names of the study subjects have been removed.

The Framingham study, sponsored by Boston University School of Medicine, Boston University School of Public Health and the NHLBI, will continue to add information from ongoing research. NHLBI will also add data from other large studies to the new program called SHARe, short for SNP Health Association Resource. SNP stands for single nucleotide polymorphism, which is a kind of genetic variation. Researchers can find out about access to SHARe data at the NIH database of Genotypes and Phenotypes.


Posted by Elizabeth Cooney at 04:08 PM

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New anesthesia method blocks pain without numbness or paralysis

By Colin Nickerson, Globe Staff

The world's hottest work in anesthesiology is being done at Harvard, where researchers are pouring pepper on pain.

Scientists at Harvard Medical School and Massachusetts General Hospital today described a new "targeted" approach to anesthesia that uses the active ingredient in chili peppers as part of an ingenious recipe for blocking pain neurons. Most critically, the technique doesn't cause the numbness or partial paralysis that is the unwelcome side effect of anesthesia used for surgery performed on conscious patients.

If approved for use in humans, the method could dramatically ease the trial of giving birth -- by sparing women pain while allowing them to physically participate in labor. It could also diminish the trauma of knee surgery, for instance, or the discomfort of getting one's molars drilled. Not only would there be no "ouch," there would be none of the sickening wooziness or loss of motor control that comes from standard forms of "local" anesthesia.

In time, the process might even be employed for major surgery on the heart and other organs, the researchers said. More prosaically, the work might also represent a breakthrough cure for the common itch.

The work on lab rats, described in the scientific journal Nature, breaks from the standard approach to local anesthesia, which usually involves anesthetics delivered by catheter tubes or injections that silence all neurons in a given region of the body, not just those that sense pain. Shutting down just the pain neurons means that patients could still feel a light touch and other non-hurtful sensations.

"This could really change the experience of, for example, knee surgery, tooth extractions, or childbirth," said Dr. Clifford Woolf, senior author of the study and a researcher in anesthesia and pain management at Mass. General. "The possibilities are almost endless."

Woolf collaborated with Bruce Bean, professor of neurobiology at Harvard Medical School, in research that employed surprisingly basic scientific principles as well as some unlikely ingredients -- capsaicin, the stuff that imparts "hot" to chili peppers, as well as an all-but-forgotten variation of a standard anesthesia, long dismissed as clinically useless.

"We plucked a little of this and little of that off the shelves," Bean said. "The project is really a great illustration of how basic biological principles can have very practical applications."

Indeed, scientists with no involvement in the Harvard study were most surprised by its simplicity.

"It's a really clever piece of work, based on one of those 'I wish I'd thought of that' ideas," said Dr. Stephen G. Waxman, head of the department of neurology at Yale University's School of Medicine. "This is an important piece of research."

There's also sweet historic symmetry to the discovery.

Boston, after all, is the city that invented feeling no pain -- at least in surgery.

Modern anesthesia was first successfully employed in surgery in October 1846, one of the greatest moments in medicine. In Boston's Public Garden, the second-largest statue -- after that of George Washington on his horse -- is a soaring pillar, adorned with roaring lions and bas-relief depictions of 19th Century surgeons, that celebrates the "discovery that the inhaling of ether causes insensibility to pain. First proved to the world at the Massachusetts General Hospital."

Not far away, modern Mass. General's original "ether dome" still stands, a national landmark and popular pilgrimage point for anesthesiologists from around the world.

The work undertaken by Woolf, Bean and post-doctoral researcher Alexander Binshtok exploits well-known concepts of how electrical signals in the nervous system depend on ion channels -- proteins that make passageways through the membranes of nerve cells. Pain-sensing neurons possess a unique channel protein, TRPV1, but one that is usually blocked by a molecular "gate."

Medicine for more than 150 years has relied on general and standard anesthetics that penetrate and suppress sensation in all neurons, not just those nerve cells dedicated to sensing pain. That's why an epidural or a simple shot of Novocain leaves a whole region of the body numb or paralyzed, because all nerves cells are affected.

Enter the hot chili pepper, in the form of capsaicin.

Enter, too, a failed derivative of the common anesthetic lidocaine, invented in the 1940s. The derivative, known as QX-314, was deemed useless because it couldn't penetrate cell membranes to block sensation. In non-pharmaceutical terms, that's a bit like having a power shovel that can't cut earth.

In experiments, the Harvard researchers found that the chili pepper ingredient generated heat that opened the gate to pain neurons, but had no similar effect on other nerve cells. Then, when they introduced the lidocaine derivative, it charged through the open channels to block pain in those neurons, but was still unable to enter other nerve cells, such as "motor" neurons that control coordination and mobility.

Thus, in rat experiments, there appeared to be a total shutdown of pain, with no apparent numbness or paralysis.

The rats received injections near nerves leading to their hind feet, and lost the ability to feel pain in their paws. But they continued to scamper about their cages normally and showed sensitivity to touch and other stimulation.

"We introduced a local anesthetic selectively into specific populations of neurons," said Bean. "Now we can block the activity of pain sensing neurons without disrupting other kinds of neurons that control movements or non-painful sensations."

Experimentation will likely move on to to sheep, then humans. One problem that needs to be addressed is whether the capsaicin might cause such a burning sensation when first injected -- before the lidocaine derivitive shuts down the pain -- that it may be too uncomfortable for use as an anesthetic. But the researchers are confident they can find a more practical "warming" chemical to open the gateways to the pain neurons.

"This method could really transform surgical and post-surgical analgesia. Patients could remain alert without suffering pain. But they also wouldn't have to cope with numbness or paralysis," Woolf said.

Noting that itch-sensitive neurons are similar to nerves that sense pain, he added: "We may have even found a good treatment for the common itch."

« Notables | Main | Today's Globe: Novartis-MIT plan, smoky building ban, FDA clinical trials oversight, Rx drug safety, Roger Jeanloz, Edmund Sonnenblick »

Thursday, September 27, 2007

Lahey analysis: Diabetes drugs increase risk of heart failure but not death

By Elizabeth Cooney, Globe Correspondent

Certain diabetes drugs should be used with caution in people who have heart disease or a history of heart failure, researchers from the Lahey Clinic report after analyzing previous studies, a finding they hope will clarify the debate on treatment.

Dr. Richard W. Nesto and his colleagues reviewed the results of seven randomized clinical trials that enrolled a total of 20,000 patients to study Actos and Avandia, two drugs from the class called thiazolidinediones, or TZDs, that lower blood sugar. Their article in tomorrow’s Lancet concludes that while TZDs do increase by 72 percent the relative risk of heart failure in people who have type 2 diabetes or are close to it, the drugs do not raise the risk of cardiovascular death. The risk of heart failure was already known.

"I view this as helpful information because if doctors want to use this drug even despite the recent debate about it, they can more appropriately select patients for the drugs in whom the risk of heart failure would be very, very low," Nesto, who is Lahey’s chair of cardiovascular medicine, said in an interview.

The Lahey report follows another review article by Dr. Steven E. Nissen of the Cleveland Clinic published in June in the New England Journal of Medicine. That analysis found a significant increase in the risk of heart attack for people taking Avandia and a borderline-significant risk of cardiovascular death. The US Food and Drug Administration added a warning to the label for Avandia in August.

Nesto said the data his group examined were more robust than the results Nissen analyzed. A panel of experts judged whether heart attacks occurred in the studies Nesto chose, and all the studies had been previously published.

"We did not find an increase in cardiovascular death despite the increased risk of heart failure and despite the findings of the other meta-analysis that there was a trend toward an increase in the risk of death," Nesto said. "I'm hopeful that this information will help clinicians if they want to use TZDs to more carefully select appropriate patients."

The drugs are still effective at lowering blood sugar, he said. Older drugs that reduce blood sugar have not raised the same degree of concern about cardiovascular side effects, but "these other drugs have not come under the degree of scrutiny that TZDs have," he said.

In a comment that appears in the Lancet, Dr. John G.F. Cleland and Stephen L. Atkin of the University of Hull in England criticize the use of blood sugar levels as a surrogate marker for how well drugs work, rather than patient outcomes such as quality of life and survival.

"All the meta-analyses consistently fail to spot the elephant in the room," they write. "Treatments should be effective rather than merely innocuous."

In a second comment, Dr. Victor Montori of the Mayo Clinic says using surrogate markers represent a false economy in drug testing.

“Patients and society may end up paying dearly for drugs that cause more harm than good,” he writes.

An editorial urges drug makers to do post-marketing studies on the long-term effects of drugs.

“Regulatory agencies must hold manufacturers’ feet to the fire to ensure that these are performed,” it says. “Unless limitations on the understanding, analysis, and communication of drug safety issues are addressed, the TZDs will simply become the latest in a series of preventable drug disasters.”

Nesto said he had not read the comments or the editorial.

“The fact remains that the target of treatment in diabetes patients is still the control of blood sugar,” he said.

Posted by Elizabeth Cooney at 07:11 PM

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Monday, September 24, 2007

Value of annual physicals debatable, study says

Annual physicals get a checkup in today's Archives of Internal Medicine.

Adult preventive health exams and women's gynecologic exams are among the most common reasons to see a doctor, but most preventive services other than Pap smears take place outside those visits, according to researchers from the University of Pittsburgh School of Medicine and Harvard Medical School.

"There's clearly a role for the type of preventive services we studied -- cancer screening, cholesterol testing and counseling about quitting smoking, losing weight and exercise," Dr. John Z. Ayanian of Harvard said in an interview. "It's a question of what's the best approach to get those provided."

Looking closely at the exams, the authors found that checkups including gynecological exams accounted for 1 in 12 adult visits to doctors. Annual exams are more common in the Northeast than in the West, according to previous research. Physicians in Boston, for example, are more likely to say they perform the annual exams than their counterparts in San Diego. People with insurance are more likely to go for physicals than people without coverage.

Annual physical exams "fill a very important role in the US healthcare system," but it wouldn't be feasible to recommend that all adults have annual physicals because there aren't enough primary care physicians or gynecologists, said Ayanian, who practices at Brigham and Women's Hospital. People get most of their preventive services when they come for an acute problem or receive care for chronic conditions, according to the authors' analysis of data from national surveys done from 2002 to 2004.

The study may help guide policy about who should be having preventive exams and what they should include, Ayanian said. People's expectations for blood tests or EKGs during checkups may increase healthcare costs without adding value, the authors found.

"We need to be very selective about what tests we recommend on a routine basis and limit them to those that are likely to have value in affecting people's health rather than reflexively ordering tests out of some sense of tradition," he said.

Posted by Elizabeth Cooney at 06:33 PM

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Monday, September 17, 2007

WSJ: Clue to estrogen and heart health found

Texas scientists may have found an explanation for why estrogen failed to protect some older women from heart disease in the Women's Health Initiative, a finding a Boston researcher called "intriguing" in today's Wall Street Journal.

Researchers at the University of Texas Southwestern Medical Center in Dallas say a molecule created when the body processes cholesterol may block estrogen from helping blood vessels stay healthy, the story says. In women long past menopause, such as those who were in the Women's Health Initiative, these molecules may have taken over estrogen receptors and blocked the effects of the hormone they started taking, the theory goes.

Dr. JoAnn Manson of Brigham and Women's Hospital and a principal investigator for the WHI, told the Journal that the Texas work may explain why women with high cholesterol did worse on hormone therapy than those with low cholesterol.

"Their overall finding ties together very nicely with the clinical-trial results," Manson said in the story. "This could help fit pieces of the puzzle together."

Posted by Elizabeth Cooney at 11:27 AM

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Friday, September 7, 2007

MIT scientists devise new way to deliver gene therapy

Scientists at MIT have created a new way to carry genes into cells that they believe will be safer than the viruses commonly used to deliver gene therapy.

Gene therapy inserts new genes into patients' cells in the hope of fighting genetic disorders or cancer and other diseases. Viruses have been the vehicles for the new genes in clinical trials, but the method carries risks. In 1999, 18-year-old Jesse Gelsinger died during his involvement in a viral gene therapy trial for liver disease; and this summer a patient in an arthritis gene-therapy trial died several days after being injected with viral therapy.

The group at MIT formed biodegradable polymers, or chains of molecules, to bring new genes to their targets. Their results appear this week in Advanced Materials.

"What we wanted to do is start with something that's very safe -- a biocompatible, degradable polymer -- and try to make it more effective, instead of starting with a virus and trying to make it safer," Jordan Green, a graduate student in biological engineering and a co-author of the paper, said in a statement released by MIT.

They tested the polymers in mice and hope to eventually bring the polymers into human clinical trials, MIT said.

Posted by Elizabeth Cooney at 10:30 AM

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Thursday, August 30, 2007

US research funding flat all over, report says

Industry R&D dollars have been leveling off at the same times as federal spending for biomedical research has flattened, says the advocacy group Research!America. Support from independent organizations, which account for 2 percent of the $116 billion spent on research in the United States last year, hasn't grown in five years.

The National Institutes of Health and other federal agencies have not seen their budgets grow since 2003, when medical inflation is taken into account. The total figure held steady at $37.7 million last year, including $28.5 billion for NIH. That has caused concern in Boston, whose teaching hospitals receive a total of about $1.4 billion a year in federal grants.

Nationally, the pharmaceutical, biotechnology and medical technology industries increased their research and development spending from $61 billion in 2005 to $64 billion in 2006, the report says. Industry budgets had been increasing along with government spending until three years ago, but have grown more slowly since. The report said there is a lag of about two years between what government and industry do.

In the independent category, made up of health associations, universities, private institutes, and state and local government funds, the total for 2006 came to $13.7 million, where it has been since 2001.

The investment in health research represents 5.5 cents of each dollar spent on health care, Research!America said. Other countries are stepping up their investments, Research!America president Mary Woolley told Science.

"The trends are not good," she said.

Posted by Elizabeth Cooney at 06:09 PM

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Wednesday, August 29, 2007

Wait for Botox shorter than for mole check, study says

Patients seeking an appointment with a dermatologist to ask about a potentially cancerous mole have to wait substantially longer than those seeking Botox for wrinkles, says a study published online today by The Journal of the American Academy of Dermatology and described in today's New York Times.

In Boston, the median Botox wait was 13 days, versus 68 days for a mole examination, the Times story said. In Seattle, the median Botox wait was seven and a half days, compared to 35 days for a changing mole.

Dr. Alexa B. Kimball, an associate professor of dermatology at Harvard Medical School, told the Times one reason could be that the demand for medical dermatologists outstrips the supply. She was not involved in the study but her research has shown that dermatologists nationwide spent an average of three to four hours a week on cosmetic treatments.

More people are seeking medical appointments with dermatologists because of increased awareness about such skin diseases as melanoma and psoriasis, Kimball said. Meanwhile, a wider array of doctors, including plastic surgeons and even some internists, offer Botox shots, she said.

"The study shows that the Botox needs of the United States are being met," Dr. Kimball told the Times. "If dermatologists stopped providing cosmetic care, it would not necessarily have an impact on medical dermatology patients."

Posted by Elizabeth Cooney at 08:31 AM

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Tuesday, August 21, 2007

Dana-Farber wins genomic research grant

Dana-Farber Cancer Institute has won $16 million to explore how viruses and human genetic variations can disrupt cellular networks, causing disease.

The National Human Genome Research Institute will fund a research team led by Marc Vidal, director of the Center for Cancer Systems Biology at Dana-Farber and an associate professor of genetics at Harvard Medical School. The group will work with colleagues from Brigham and Women's Hospital, Harvard Medical School and the University of Notre Dame through the new Center of Excellence in Genomic Science.

"We decided to try to see how pathogens are affecting the complex networks formed by our molecules, and relate that back to the genetic differences between individuals," Vidal said in an interview.

Posted by Elizabeth Cooney at 10:10 AM

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Friday, August 10, 2007

Stem cell scientist never planned to leave, Harvard says

kevin eggan85.bmpHarvard Stem Cell Institute scientist Kevin C. Eggan (left) has no plans to move to a Kansas City, Mo., research center, a Harvard spokesman said today, despite a report in today's New York Times saying he has delayed leaving because of political opposition in Missouri to working with embryonic stem cells.

Eggan, whose Harvard lab is supported by the same Kansas City donors that built the Missouri research center, did not immediately return a phone call seeking comment, but a Harvard Stem Cell Institute spokesman said Eggan isn't going anywhere.

"There are not and there have not been any plans for Kevin Eggan to leave the Harvard Stem Cell Institute," B.D. Colen said in an interview. "He was making a general comment about anyone who was considering going to Missouri to do stem cell research."

The Times quoted Eggan in a front-page story about political and financial roadblocks to a $300 million expansion of the Stowers Institute for Medical Research, funded by Kansas City philanthropists Jim and Virginia Stowers. Even though Missouri voters approved a constitutional amendment in November that allows embryonic stem cell research, many new bills to limit research have been proposed in the state legislature, stalling the recruitment of scientists, the story said.

Eggan is a founding member and assistant investigator of the separate Stowers Medical Institute based in Cambridge, which supports researchers in an arrangement that follows the Howard Hughes Medical Institute model of funding scientists' work at their home institutions. Stowers is providing $5.9 million over five years to Eggan's lab, according to a 2005 Harvard statement.

The Stowers Medical Institute also supports Chad Cowan at the Center for Regenerative Medicine at Massachusetts General Hospital and the Harvard Stem Cell Institute.

Jim Stowers said in 2005 that he and his wife were supporting research at Harvard rather than in Missouri because of fears that the Missouri legislature would ban stem cell research, according to that Harvard statement.

Posted by Elizabeth Cooney at 01:46 PM

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Thursday, August 9, 2007

Beth Israel Deaconess names research operations head

mason150.bmpBeth Israel Deaconess Medical Center has named Randy Mason (left) vice president of research operations, the hospital said today.

He comes to Beth Israel Deaconess from Partners HealthCare, where he was chief of staff to the chief academic officer and director of research operations. Before that he had been chief administrative officer for the Harvard/Partners Center for Genetics and Genomics and budget director and comptroller for Partners Corporate.

Mason will be responsible for research administration functions, including grant administration, research facilities and clinical trial operations. He received a bachelor's degree in biology from the University of Albany and an MBA in health care administration from the Baruch College Zicklin School of Business/Mount Sinai School of Medicine.

Posted by Elizabeth Cooney at 05:40 PM

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Thursday, August 2, 2007

Korean cloning fraud covered an accidental stem cell first, Harvard paper says

Harvard scientists have answered a question that lingered after Korean scientists retracted their fraudulent claim
that they had cloned the first human embryonic stem cells: Where did the stem cell line they created come from?

george q. daley100.bmpKitai Kim, Dr. George Q. Daley (left) and their colleagues at Children's Hospital Boston and the Harvard Stem Cell Institute report today in Cell Stem Cell that the embryonic stem cells created by the Korean lab resulted not from somatic cell nuclear transfer, a technique in which a person's DNA is injected into a donor egg cell that has had its own DNA removed, but from parthenogenesis, the process of making an embryo from the donor egg alone.

Cells derived from parthenogenesis carry a distinct genetic fingerprint because they have a duplicate set of chromosomes from the egg. Most of the genetic sequences are identical, but some show differences from the donor egg. Investigators looking into the Korean claims last year said parthenogenesis could not explain these different patterns, the paper said.

Kim and Daley's group analyzed the cells further and found that the DNA differences were clustered at certain points, just as they are in experiments on parthenogenesis in mice.

The Koreans appear to have created the first human embryonic stem cells from a woman's egg alone, the paper says.

Daley's lab is studying parthenogenetic cells as another possible source of embryonic stem cells to treat disease.

A Children's Hospital interview with Daley is here.

Posted by Elizabeth Cooney at 12:40 PM

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Tuesday, July 31, 2007

Two Mass. scientists win Keck awards

Two Massachusetts scientists are in the 2007 class of the W.M. Keck Foundation's Distinguished Young Scholars in Medical Research.

The Los Angeles philanthropy awards grants of up to $1 million each to five junior faculty members in the United States. Institutions make nominations by invitation only.

amy wagers150.bmpAmy Wagers (right) of the Harvard Stem Cell Institute, Joslin Diabetes Center and Harvard Medical School will study how to slow down or reverse the natural process of aging, which has potential implications for treating such age-related diseases as diabetes, immune deficiencies, muscle weakness and cancer, the foundation said.

job dekker150.bmpJob Dekker (left) of University of Massachusetts Medical School will study how chromosomes are regulated by comparing cancer cells to normal cells, which may uncover defects that cause malignancy, potentially leading to advances in treating cancer, the foundation said.

The three other winners are Wallace Marshall of the University of California, San Francisco, who will study blue-green algae to gain insights into human ciliary disorders such as polycystic kidney disease and retinal degeneration; Dr. Xander Wehrens of Baylor College of Medicine, who will investigate the mechanisms of specialized protein complexes in excitable cells, such as heart muscle; and Jennifer Zallen of Memorial Sloan-Kettering Cancer Center, who will focus on a fruit fly’s cell structure to develop approaches to analyze cell behavior and structure in living embryos, the foundation said.

Posted by Elizabeth Cooney at 09:54 AM

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Thursday, July 26, 2007

On the blogs: the new 'valley of death,' controlling healthcare costs

On Nature Network Boston, M. William Lensch, a scientist at Children's Hospital Boston and the Harvard Stem Cell Institute, writes a mournful entry about the gap created when researchers must depend on small foundation grants now that government funding of science -- which helps pay for a sponsoring institution's overhead -- is shrinking. It's a new version of the "valley of death" between academic research and commercialization of a discovery.

"With private grants ... you might be paying for all your own reagents but you are not paying your share for the bench space you have, the light shining down on it, or the salary of who sweeps the floor around it relative to someone with the same amount of grant support from the NIH," he writes. "Dig? Here’s where the Valley of Death comes in."

On WBUR's CommonHealth, John E. McDonough of Health Care For All outlines the predicament facing Massachusetts as it expands access to coverage while costs rise. He questions the objectives of the state Quality and Cost Council, created by the healthcare law.

"The set of goals embraces a popular hypothesis in health policy -- that if we just get quality right, given the documented amount of clinical waste in our system, that’s the magic pill to cure our cost disease. Wouldn’t it be luverly?" he writes. "What if this hypothesis is wrong? What if we do everything quality-wise and costs still rise at destructive, unsustainable rates? Are we willing to consider "R" word - regulation?"

Posted by Elizabeth Cooney at 12:11 PM

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Wednesday, July 11, 2007

Covering people before 65 reduces health care costs later

Providing health care to uninsured adults before they qualify for Medicare coverage may not only improve their health but also reduce costs after they turn 65, a Harvard study says.

People who haven’t had insurance coverage are significantly more likely to report poor health before the age of 65, the authors report in tomorrow’s New England Journal of Medicine.

They looked at data from the national Health and Retirement Study to compare health care expenditures between insured and uninsured adults at age 59 and 60 and then again after 65. They concluded that expanding health insurance coverage for uninsured people before 65 might be offset by savings in health care costs that would come later, particularly for people who have cardiovascular disease or diabetes.

"It may be less costly than people thought," Dr. J. Michael McWilliams, a research associate at Harvard Medical School, said in an interview. "Earlier coverage improves health and reduces health care needs."

These findings are especially important as baby boomers reach 65, he said. The current generation of adults has higher rates of obesity and hypertension than their parents', pointing to more chronic disease and a greater need for preventive care, said McWilliams, who also practices general internal medicine at Brigham and Women’s Hospital.

When previously uninsured adults reach 65, they have significantly more doctor visits and hospital stays than adults who had coverage before. The uninsured patients also had more out-of-pocket expenditures after 65 that were not covered by Medicare, the authors found.

"Not only does providing coverage to these adults substantially reduce their health care needs after 65, but it also protects them financially," McWilliams said.

Posted by Elizabeth Cooney at 05:56 PM

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Monday, July 2, 2007

Scientists report win against bacterial biofilms

Two scientists from Boston University and a Harvard-MIT program have engineered an organism to fight bacterial biofilms.

Writing in the online Proceedings of the National Academy of Sciences, Timothy K. Lu and James J. Collins report that they created a bacteriophage -- a virus that infects bacterial cells -- that releases an enzyme to attack both the bacterial cells in the biofilm and to disperse the biofilm itself.

Bacteria commonly live in biofilms. They can be found in dental plaque or water pipes or on medical devices. A source of infection and contamination, biofilms pose a particular problem when they are resistant to antibiotics.

Bacteriophages work in a different way than antibiotics when they infect bacterial cells. The authors say that adding enzymes makes the bacteriophages much more effective than previous efforts that didn't incorporate enzymes.

Lu is from the Harvard-MIT Division of Health Sciences and Technology and Collins is from BU's Center for BioDynamics.

Posted by Elizabeth Cooney at 02:29 PM

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Wednesday, June 27, 2007

Keeping promises to research subjects

By Elizabeth Cooney, Globe Correspondent

Academic researchers keep their distance from pharmaceutical companies providing drugs for clinical trials, but sometimes that arms-length remove can lead to problems, Harvard authors say.

In an article in tomorrow's New England Journal of Medicine the Harvard scientists explore a case in which research subjects sued the drug company Amgen when a Parkinson's therapy being tested by the University of Kentucky Medical Center was no longer available to them. The study was stopped early because of concerns that the drug was neither safe nor effective, but some subjects said it helped them and wanted to keep taking it.

Participants had signed informed-consent agreements that said they could continue getting the drug after the trial ended, but the court ruled last year in Abney v. Amgen that the form each subject signed was a contract between the subject and the researchers, not Amgen. That meant Amgen had no obligation to provide the drug.

"I think this is one of those issues that kind of lurk below the water line but probably is quite prevalent," Michelle M. Mello of the Harvard School of Public Health said in an interview. "Consent forms promising access to study drugs are fairly routine. We want subjects to feel that whatever promises that are made to them are going to be carried out unless there’s a very good reason not to."

Mello and co-author Dr. Steven Joffe of Harvard Medical School suggest that research centers could solve the problem by ensuring that promises made to trial subjects are legally binding on the sponsor or met by the research center and that any limits to promises are clearly spelled out.

"Much of the problem highlighted by Abney can be avoided through more careful drafting of contracts," the authors write. "Notwithstanding the advantage of an arms-length relationship between academic investigators and industry sponsors, such an arrangement has undesirable legal consequences."

Posted by Elizabeth Cooney at 05:00 PM

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Thursday, June 21, 2007

NCI cancels breast cancer prevention study

By Elizabeth Cooney, Globe Correspondent

In an unusual step, the National Cancer Institute has canceled a $130 million clinical trial to compare how well two drugs prevent breast cancer.

Called the P-4 trial because it is the fourth such prevention study undertaken by the federal agency, it would have enrolled more than 12,000 women at high risk for breast cancer at 500 sites and followed them for years. The termination of the study before it began recruiting patients comes at a time when NCI is straining under four years of tight budgets.

The women would have received either raloxifene, an estrogen-blocking drug approved to treat osteoporosis but now prescribed to stop breast cancer, or letrozole, a compound from a newer class of drugs called aromatase inhibitors that deplete the production of estrogen. Both target estrogen because it promotes the growth of cancer cells.

Dr. Bruce Chabner, clinical director of the Massachusetts General Hospital Cancer Center, was on a scientific panel that last week advised NCI director Dr. John E. Niederhuber to pull back the P-4 trial. Niederhuber, who called for a review of the trial in January, visited Mass. General Monday and discussed the trial in previously scheduled sessions with Boston researchers and clinicians.

Chabner said the trial's cost was considered along with scientific concerns, including the desire to better match powerful drugs with the individuals who can be helped by them.

"I think in times when the budgets were really generous the NCI would probably have gone ahead with the study. It's not so much a criticism of the trial as it's expensive when there are other priorities that are very important," he said. "It is an unusual step. But these are unusual times."

The NCI's June 19 letter to the study's principal investigators at the University of Pittsburgh cited troubling complications caused by the two cancer prevention drugs and the relatively small number of women -- 3 or 4 out of 100 -- who benefit from them. The decision not to go forward with the study was first reported in Wednesday's Washington Post.

"While the P-4 study may provide another possible option for women at risk for breast cancer, the dangers of introducing these drugs, with their many known side effects, outweighs their potential until we are better able to determine who will benefit from these interventions and what the longer-term effect may be," the letter said.

Tamoxifen -- studied in 20,000 women in the P-1 trial of the early 1990s -- is currently the only drug approved for the prevention of breast cancer. Doctors prescribe it to treat women with breast cancer, to avoid a recurrence or in some cases to prevent it in the first place. Tamoxifen and raloxifene were compared in a large trial that last year reported they had just about the same effectiveness in preventing cancer, but raloxifene had fewer side effects.

Tamoxifen is linked to uterine cancer, blood clots and cataracts. Raloxifene was associated with a lower risk of these complications. Aromatase inhibitors are known to cause brittle bones, a particular worry for older women who might be taking them.

Chabner said the advisory panel's consensus was that this expensive trial was "not going to change the practice of medicine."

"Everybody agrees that the number-one priority is not to compare drug X to drug Y," he said. "It's to really define who is at highest risk for breast cancer so we don't have to treat 100 patients to prevent three or four or five cancers. If we can treat 10 patients and prevent 5 cancers, then it's going to be more reasonable."

NCI holds out hope for personalized medicine to better fit treatments to patients.

"Targeted chemoprevention must rely on individual genomic and proteomic signatures to identify those patients for whom the risk-benefit ratio justifies using a chemopreventive drug," its letter said. "NCI will continue to have a strong commitment to cancer prevention and search for ways in which such patients can be provided highly personalized approaches to prevention."

Other ongoing studies are examining how well other aromatase inhibitors protect women against breast cancer compared with placebos. One trial, funded by the National Cancer Institute of Canada and looking at exemestane, is led by Dr. Paul E. Goss, also of Mass. General.

"I feel strongly that aromatase inhibitors should be tested in prevention but always believed that the trial should be against a placebo," he said in an e-mail. "I am not privy to all the forces that fed into the NCI director's decision but I have no doubt that competing priorities were a big part of it. It is true that our trial would have reported before (P-4) and I agree that (P-4) may therefore not have changed practice."

Chabner said another weakness of the P-4 trial was that letrozole, the aromatase inhibitor being compared with raloxifene, will no longer be protected by its patent in 2011, meaning its manufacturer will have no incentive to seek FDA approval if it is shown to be effective.

Dr. Harold J. Burstein, a breast cancer specialist at the Dana-Farber Cancer Institute, said oncologists will have to infer from other studies in other countries how the different kinds of chemoprevention drugs compare. Dana-Farber would likely have been one of the many sites for the P-4 trial, he said.

"There's no doubt we need more studies in breast cancer prevention and the study being proposed was a very practical strategy to compare two likely effective strategies," he said. "There will be a void when a patient comes to see a doctor eight years from now and says, 'Which one should I take?'"

Posted by Elizabeth Cooney at 10:27 AM

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Wednesday, June 20, 2007

Journal voters stray from the evidence

The results are in from the New England Journal of Medicine's first online poll of clinical decisions, and the winner was not a slam-dunk.

"What we learned from this is that evidence-based medicine is easy to talk about but hard to implement," editor-in-chief Dr. Jeffrey M. Drazen said in an interview.

Last month the journal asked readers to vote on how to handle the fictitious case of a woman who wanted to cut down on her medications for mild, persistent asthma. The vignette was created to accompany two articles on asthma treatment.

"People read those two papers and the vignette and came to very different conclusions," Drazen said.

Readers were given three choices to vote on. When the 6,085 votes from 113 countries were counted, two of the three choices were almost a tie, with only eight votes separating them. But the winner, with 37.5 percent of the votes, was not the choice consistent with what the two studies concluded, Drazen said.

"It appears that although we as physicians use new data, we do not slavishly follow them," Dr. Laura Fredenburgh of Brigham and Women's Hospital writes in tomorrow's journal.

That fits with the more than 340 comments the journal received, Drazen and Fredenburgh said. The doctors said they picked out different parts of the fictitious patient's story to guide their decisions.

Drazen said he was encouraged by the number of votes and the thoughtful nature of the comments.

"I was amazed," he said. "We'll probably do it again in the fall."

Posted by Elizabeth Cooney at 05:00 PM

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Wednesday, June 6, 2007

Harvard, Whitehead scientists report embryonic stem cell advances

By Colin Nickerson, Globe Staff

Scientists in Massachusetts and Japan say they have created embryonic stem cells using procedures that might overcome some of the ethical objections to the controversial research as well as a major scientific hurdle.

Most dramatically, three of the four research findings announced today used a highly experimental approach that avoids the destruction of embryos, which critics equate to taking a life. Instead, they used genes and retroviruses to coax adult cells back to an embryo-like state.

The other project, meanwhile, points to a new, readily available source of embryonic stem cells, which would allow researchers to bypass a bottleneck in current efforts at Harvard University to clone human stem cells genetically matched to a patient with a particular disease -- the inability to find women willing to donate unfertilized eggs for the research.

All of the research reported in today's Nature and Cell Stem Cell involved mice, but scientists say they believe the results could be replicated in humans.

"These new studies, done with mice cells, point the way to experiments that can be tried with human cells," said Douglas Melton, a Harvard stem cell scientist. "This represents some of the most exciting work in stem cell biology and genetic reprogramming."

In one of the papers, Melton's colleague at the Harvard Stem Cell Institute, Kevin Eggan, defied long-standing scientific dogma that fertilized eggs cannot be used to clone embryonic stem cell lines. Eggan carried out somatic cell nuclear transfer -- cloning -- by removing chromosomes from a one-cell fertilized egg and replacing it with DNA from another, mature cell. The modified cell began dividing, and he then harvested stem cells from the resultant embryo.

Although less razzle-dazzle than the techniques used in the other research, Eggan's work holds the best prospect of creating human embryonic stem cell lines in the near future.

The study by Eggan suggested that researchers could use the genetically-defective fertilized eggs discarded by the thousands daily at fertility clinics across the United States. Such one-cell embryos are treated as waste because they stand no chance of attaching to the womb and forming a healthy embryo.

"This represents a wonderful way of obtaining something good -- medical research that could lead to therapies for human disease -- out of something that would just be thrown away," Eggan said in an interview.

The findings by scientists from Harvard, the MIT-affiliated Whitehead Institute, Massachusetts General Hospital, and Japan's Kyoto University also represented the most successful attempts to date to find new ways to make embryonic stem cells that might overcome some of the ethical opposition from religious groups who oppose destruction of human embryos and from womens groups worried about the implications of female donors undergoing tricky hormonal therapy to produce eggs for research.

"All in all, this is encouraging, exciting progress that shows real willingness among scientists to weigh ethical concerns even as they pursue science objectives," said Dr. William Hurlbut, a neuroscientist and ethicist at Stanford University who serves on the President's Council on Bioethics. "The science is critical, of course. But so are many ethical concerns. We've got to calm down as a nation and stop the acrimony and misrepresentation flung by both sides."

Embryonic stem cells, considered crucial to medical science and eventual treatment for an array of terrible diseases, have the ability to form any of the 220 basic tissue types in the body -- from bone cells to brain cells.

But research on the cells has been slowed in the United States since President Bush, citing concerns about destruction of embryos, sharply limited federal funding of the science in 2001.

Work done by teams working independently of one another at Harvard, the Whitehead Institute, and Kyoto University involved the genetic manipulation of mouse skin cells back into an embryonic state. No eggs were used, no embryos destroyed -- a stunning advance, although perhaps difficult to replicate in humans.

"You can really turn back the clock from adult to embryonic stem cells," said Konrad Hochedlinger of the Harvard Stem Cell Institute and Massachusetts General Hospital's Center for Regenerative Medicine. "But success in humans might be much more difficult than in mice."

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Wednesday, May 16, 2007

Polls are open at the New England Journal of Medicine

Tomorrow’s New England Journal of Medicine is taking a vote.

drazen150.bmpFor the first time, physicians will be asked to weigh in on what they would do for a patient, based on research papers published in the current issue and what they read about a fictitious case. Their choices will be tallied online for four weeks and their comments posted in an experiment to better connect with readers, editor-in-chief Dr. Jeffrey M. Drazen (left) said in an interview.

"We dreamed it up to engage more with our audience," he said. "We’ve been in broadcast mode and now we’ll be in receiving mode."

The answers to the poll may shed light on therapeutic decisions that physicians make every day, Dr. Richard Schwartzstein, associate chief of pulmonology and critical care medicine at Beth Israel Deaconess Medical Center, said in an interview. He was not involved in creation of the interactive poll or the studies on which this week's case is based.

"I think it’s a very intriguing idea," he said. "We know that the delay between the publication of key articles or guidelines and the actual implementation of the recommendations around the country is quite long, sometime years."

One example is the wide variation in how recommendations to prescribe aspirin after people have heart attacks are applied, Schwartzstein said.

"People have always speculated whether that’s because the publications don’t get out into the community as rapidly as you might think or whether there is skepticism on the part of many doctors for the recommendations and data upon which they are based," he said. "Or they just don’t think it applies to their patients."

First up in the Journal is the case of a 30-year-old woman with mild persistent asthma who wonders if she should change her medications. The vignette is followed by three choices and an essay to support each option. Readers can make their picks and explain why online.

The articles that prompted the exercise have clear clinical implications for the treatment of mild asthma, Drazen said. He expects there to be three or four other occasions in the coming year when the journal will open up a forum to sample what decisions might be made at the bedside or in the doctor’s office.

Clinical trials reported in scientific journals get practitioners thinking about important issues, but they don’t always relate directly to the real world, he said. Articles are more likely to give a general level of direction as opposed to specific guidance.

"Evidence-based medicine is somewhat of an illusory thing," he said. "Very few patients fit the inclusion criteria for a clinical trial. It’s like putting together a jigsaw puzzle when the pieces don’t quite fit."

Poll results from clinicians may add another piece of information about how clinical decisions are made.

"We hope to learn from them as well as having them learn from us," Drazen said.

Posted by Elizabeth Cooney at 05:45 PM

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Tuesday, May 15, 2007

Even a little exercise helps, study shows

Even small amounts of physical activity can boost the fitness of postmenopausal women who are sedentary and overweight, an article in tomorrow's Journal of the American Medical Association says.

As little as 72 minutes of exercise a week showed benefits for women in a trial led by Dr. Timothy S. Church at Louisiana State University. More exercise -- up to about three hours a week -- meant higher fitness levels, as measured by the amount of oxygen they consumed while cycling or walking. But the exercise did not affect cardiovascular risk factors such as blood pressure or weight.

These findings answer a question researchers have had about what the minimum "dose" of exercise might be to deliver health benefits, I-Min Lee, an epidemiologist at Brigham and Women's Hospital, writes in a related editorial. Fitness levels are strong predictors of chronic disease and premature mortality, previous studies have shown.

Lee writes: "This might be succinctly summarized for patients and clinicians as 'Even a little is good; more may be better!'"

Posted by Elizabeth Cooney at 05:58 PM

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Harvard scientists to discuss stem cell research with Charlie Rose

daley and melton.bmpHarvard scientists Dr. George Daley (at left in photo) and Doug Melton (center) will discuss embryonic and adult stem cell research on the fifth installment of the Charlie Rose Science Series on PBS. It airs at 11 p.m. tomorrow on Channel 2.

The other guests are Larry Goldstein of the University of California at San Diego and Story Landis of the National Institute for Neurological Disorders and Stroke. Sir Paul Nurse, president of Rockefeller University, will be the co-host.

Posted by Elizabeth Cooney at 12:18 PM

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Monday, May 7, 2007

CIMIT awards $5m to medical device researchers

Proposals to build new devices to help premature infants, to inject medicine without breaking the skin and to guide surgeons operating on the brain were among projects to win $5 million in grants from the Center for Integration of Medicine and Innovative Technology, the consortium announced today.

CIMIT, composed of Boston-area teaching hospitals and engineering schools, made 37 grants that range from $40,000 to $100,000. Twenty-two have military applications, acording to CIMIT, which receives support from the US Department of Defense as well as its members.

Dr. Riccardo Barbieri of Massachusetts General Hospital won a grant to develop a computational tool based on a premature infant's heartbeat to predict episodes when they stop breathing.

Mark Horenstein of Boston University will demonstate a way to inject medications through the skin using nanoparticles, leaving no wound behind.

Dr. Nobuyuki Nakajima of Brigham and Women's Hospital will work to improve how instruments can be navigated to diagnose and treat brain injury or disease.

"Our goal ... is to bring life-changing technology to patients as quickly as possible," Dr. John Parrish, CIMIT founder and director and Vietnam War battlefield surgeon, said in a statement. "We are especially aware of the needs of soldiers wounded on the battlefield."

Posted by Elizabeth Cooney at 06:56 AM

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Thursday, May 3, 2007

Genetic link to heart disease found

By Colin Nickerson, Globe Staff

Scientists using powerful new genetics research methods have for the first time identified a snippet of DNA common to many people that dramatically increases the chances of developing heart disease.

The discovery, revealed in two large and independent studies in North America and Europe, indicates that 75 percent of Caucasians possess a previously unknown genetic defect that puts them at elevated risk of a heart attack regardless of bad habits -- smoking, for example -- or bad health, such as hypertension or high cholesterol levels. The increased risk is most substantial for the 25 percent of Caucasians who have two copies of this defective DNA, one on each set of chromosomes.

"This is one of the most significant genetic risk factors found to date for heart attack," said Dr. Kari Stefansson, chief executive of DeCode Genetics, an Iceland-based company famous for its gene-hunting prowess.

"The variant may account for one-fifth of heart attacks" among white Europeans and North Americans, he said in a telephone interview.

Heart disease is the deadliest affliction in the western world. In the United States alone, some 1.2 million people suffer a heart attack every year and at least 452,000 die from it, according to the American Heart Association.

Human DNA is mostly the same, with less than 1 percent of the "letters" that make up the genetic code varying among individuals. Those differences, called gene variants, can account for such distinguishing traits as green eyes or blonde hair. But gene variants can also translate into susceptibility to diseases.

The newly-identified genetic variant appears unrelated to other risk factors for heart attack, according to the studies, which were published online today by the journal Science.

"This is a very common genetic variant, which has a very strong effect on heart disease risk, that isn't related to any of the other factors we know of," said Dr. Ruth McPherson, an endocrinologist at Canada's University of Ottawa Heart Institute, leader of the other research team.

Scientists believe that they will ultimately find many genes that can contribute to heart disease, just as there might be genes that protect the heart. They also stress that environmental and lifestyle factors can cause heart disease in individuals without a genetic predisposition.

Intense medical interest was stirred by the genetic location of the heart disease variant. Both studies showed the morsel of DNA appears to be encoded on the same chromosome in almost exactly the same "neighborhood" as genes identified in papers published only last week as connected to the most common form of diabetes.

At the very least, that's extraordinary coincidence. It also raises the possibility of a lethal bunching of DNA responsible for multiple ailments.

"It's a stunner," said Dr. Francis S. Collins, director of the National Human Genome Research Institute, who was not involved in either heart study. "It seems like this place [possibly] carries all of that weight for two very common and very dangerous diseases."

No one knows why DNA variants associated with the two diseases might lie in such close genetic proximity.

"This may suggest a causal link between these two disorders that is much deeper than previously suspected," Dr. David Altshuler, director of medical and population genetics at the Broad Institute, a Cambridge research center affiliated with Harvard and the Massachusetts Institute of Technology, wrote in an e-mail.

"It is too early to say anything with certainty," he said, "but very exciting days, to be sure."

Altshuler led one of the diabetes research teams but was not involved with the hunt for the heart disease genes. Of the overall heart variant discovery, he said: "It is an extremely convincing and exciting finding, with great potential to influence our understanding of coronary artery disease."

The Canadian and Icelandic researchers compared people who had heart disease with healthy individuals, looking for common genetic variants that were far more prevalent among the heart patients. They found that an individual who possesses two copies of the newly-identified genetic variant has a 30- to 40 percent higher risk of suffering a heart attack than an individual of comparable age and health who does not. A person carrying a single copy of the defect has a 15- to 20 percent increase in risk.

Discovery of the genetic variant represents a potentially important tool for diagnosing people at risk of heart disease, one which might become available to hospitals and clinics as early as this year, according to DeCode's Stefansson. But researchers admit that the genetic research is still a long way from yielding new treatments.

"The hope is that by discovering genetic predisposition to heart attack, we can identify people who are at greater risk for genetic reasons alone," said McPherson, "and in the long run can develop custom-tailored treatments."

Other studies have linked heredity to heart disease, but previously identified "bad" genes have tended to be either rare or linked to other illnesses that cause or exacerbate coronary ailments.

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Wednesday, May 2, 2007

Tight diabetes control doesn't harm cognitive function, study finds

Researchers led by a team at the Joslin Diabetes Center report in tomorrow's New England Journal of Medicine that tightly controlling blood sugar levels does not impair long-term cognitive function for people with type 1 diabetes.

Type 1 diabetics, whose immune systems destroy cells in the pancreas that make insulin, must monitor the level of sugar in their blood and inject insulin or use an insulin pump to keep down blood sugar. High levels can lead to such complications as blindness, heart disease and kidney failure.

Tight control of blood sugar, however, can unintentionally result in episodes of hypoglycemia, or low blood sugar levels. Hypoglycemia can lead to confusion, coma and convulsions. That has raised concerns that over time, hypoglycemia could cause long-term cognitive problems.

The Joslin study followed 1,441 type 1 diabetics for 12 years, following up on an earlier study of the same participants that showed that after 6 years, diabetics with tightly controlled blood sugar showed the same cognitive function as diabetics on less intensive therapy. The results after 18 years confirmed the earlier findings.

"While acute episodes of hypoglycemia can impair thinking and can even be life-threatening, type 1 diabetes patients do not have to worry that such episodes will impair their long-term abilities to perceive, reason and remember," Dr. Alan M. Jacobson, head of Joslin's behavioral and mental health research section and lead author of the study, said in a statement.

Posted by Elizabeth Cooney at 06:51 PM

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Nobelist takes funding plea to Washington

mello150.bmpNobel laureate Craig C. Mello of University of Massachusetts Medical School (left) is taking his plea for more science funding to Capitol Hill, along with four other Americans who swept the 2006 science Nobel prizes.

Mello, who won the 2006 prize in medicine or physiology with Stanford’s Andrew Z. Fire for their discovery of gene silencing known as RNA interference, was invited to speak this afternoon at a hearing of the Senate subcommittee on science, technology and innovation. Roger D. Kornberg (chemistry) and John C. Mather and George F. Smoot (joint winners in physics) were also on the agenda.

"We need a call to arms, a call to fund science broadly in this country," a transcript of Mello’s prepared testimony said. "This isn’t science for the sake of science, but science for the sake of medical advances and lives to be saved."

Mello has deplored the decline in federal funding for research since the October day his prize was announced, insisting that the type of work he and Fire did 10 years ago would not win grants in today’s climate. They weren’t looking for RNAi when they found it, he said, but in eight years it went from being a puzzle to being the subject of a 1998 Nature paper to being applied as a tool for treating disease.

"This could happen only because we are in an era unprecedented for scientific discovery," he said, citing the sequencing of the human genome made possible by government investment that is now not keeping pace with inflation. "What other discoveries, what work like RNAi ... will be missed?"

Posted by Elizabeth Cooney at 06:05 PM

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Neurologists here for conference

Boston researchers are among neurologists and neuroscientists delivering more than 1,000 presentations and poster sessions at the annual meeting of the American Academy of Neurology at the Hynes Convention Center in Boston. The weeklong conference has drawn more than 10,000 people, the group said.

Local presenters include Dr. Miguel Hernan of the Harvard School of Public Health, who is presenting his study showing that depression may be an early symptom of Parkinson's disease.

Evan L. Thacker, also of the Harvard School of Public Health, was scheduled to describe research exploring how moderate to vigorous exercise might be associated with the risk of developing Parkinson's disease.

Dr. Jeffrey Ellenbogen of Harvard Medical School was slated to talk about his study's conclusion that sleep not only protects memories from outside interferences, but also helps strengthen them.

Posted by Elizabeth Cooney at 03:02 PM

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Friday, April 27, 2007

This week in Science

Two papers in Science, including one by Harvard researchers, were among four published yesterday in Science and Nature Genetics on genetic risk factors for developing diabetes. Alice Dembner describes them in today's Globe.

Reseachers from Massachusetts General Hospital, Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center and Brigham and Women's Hospital are part of an international team reporting on a new mechanism involved in resistance to "smart" cancer drugs Iressa and Tarceva that target lung cancer cell growth.

Scientists have identified a new gene that helps regulate the body's clock and Giulio F. Draetta of Merck
Research Laboratories
in Boston and colleagues report on a molecular component of this clock involved in the
length of the circadian period.

A team that includes researchers from the CBR Institute for Biomedical Research and Harvard Medical School in Boston reveal how the influence of micro-RNAs, small RNA molecules that regulate gene expression, extends to the immune system.

Posted by Elizabeth Cooney at 02:24 PM

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Wednesday, April 25, 2007

More than a quarter of doctors paid by industry, survey shows

Lunch in the doctor's office courtesy of pharmaceutical company reps and payments to physicians who speak at conferences aren't new, but the proportion of physicians reporting that they get money from industry and how that varies by specialty may be important for efforts to control these relationships, according to an article in tomorrow's New England Journal of Medicine.

Researchers at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School conducted a national survey of 3,167 physicians and found that 94 percent had some kind of relationship with the pharmaceutical or medical device industries. The respondents reported receiving drug samples (78 percent), gifts of food (83 percent) and sports or cultural event tickets (7 percent). More than a third (35 percent) received reimbursement for continuing medical education or meeting expenses.

More than a quarter (28 percent) got paid for consulting, serving on an advisory board or speakers bureau, or enrolling patients in clinical trials. This surprised the authors more than the 94 percent of doctors with some sort of tie, which could have been as little as a mug or pen, Dr. David Blumenthal said.

"I figured that direct payments went pretty much to people who were academic or opinion leaders, but it seemed to be far more common," he said in an interview. "The fact that more than a quarter of physicians are actually getting direct monetary payments tells me this remains an important phenomenon in American medicine and that the rules and regulations put into effect have not eliminated it."

In 2002, the Pharmaceutical Research and Manufacturers of America, the industry's trade group, put in place voluntary guidelines limiting certain gifts. Leading physician groups have also adopted similar rules.

Pediatricians were less likely than internists to receive payments or reimbursements. Anesthesiologists didn't get samples, reimbursements or payments as often as family practitioners, internists or cardiologists.

Cardiologists were more than twice as likely to be paid by industry as family practitioners were, perhaps because they are recognized as the ones who set standards for prescribing widely used heart drugs, the authors suggested.

Where the physician practiced also made a difference, they found. Group practice doctors were six times as likely to get samples, three times as likely to receive gifts, and almost four times as likely to receive payments for professional services such as consulting than doctors in hospitals, clinics or staff-model HMOS. Male doctors and those with fewer Medicaid or uninsured patients also were more likely to receive payments.

"Specialties, organizations and practice leaders with an interest in reporting and managing physician-industry relationships may need to develop guidelines and recommendations that are specific to the context of each specialty and setting," the authors wrote.

Posted by Elizabeth Cooney at 05:40 PM

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Tuesday, April 24, 2007

Gene variants tied to progression of eye disease

Age-related macular degeneration is the most common cause of vision loss in people over 60, but only some of the people who have the early or intermediate stages of the eye disease develop its more serious form, losing so much of their central vision that they can no longer drive or read.

Researchers led by Dr. Johanna M. Seddon of Tufts-New England Medical Center report in tomorrow’s Journal of the American Medical Association that people with variations in two common genes have a two- to four-times higher risk of developing advanced AMD. When combined with smoking and obesity, already known risk factors for advanced AMD, the gene variations pushed the risk of advanced AMD 19 times higher.

"We have shown how genetic variations do add to progression," Seddon said in an interview about the clinical trial, which followed 1,466 people for about six years. "Genetic factors, smoking and obesity are all independent factors related to progression of AMD and they seem to be additive."

But Seddon and her co-authors, who include Sarah George and Bernard Rosner of Harvard, say it's too early to call for genetic screening. Many, but not all, people with the gene variations progress to advanced AMD, but so do some people without the gene variation.

"The story is unfolding and we have a lot more to learn," Seddon said. "Genetic screening is premature at this point."

They do recommend that people exercise, eat a healthy diet and not smoke, based on previous work implicating the same risk factors for cardiovascular disease in AMD. Seddon showed in 1994 that diet is linked to AMD, and in 1996 that smoking is related.

Dr. Bruce P. Rosenthal of Lighthouse International, a non-profit organization established to help people with vision loss, said the study will be valuable as researchers continue to seek the root causes of the disease.

"While we have known for many years that smoking and being overweight contributes to the risk of macular degeneration, the findings of a genetic link for the progression of macular degeneration from early or intermediate stages to advanced disease are indeed significant and will have a major impact on future study and possible treatment of AMD," he said in a statement.

Rosenthal was not involved in the study, which was funded by the National Eye Institute and other grants.

Posted by Elizabeth Cooney at 05:27 PM

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Angina drug helps with symptoms but doesn't reduce risk of further heart problems, study says

The anti-angina medication ranolazine safely eased chest pain in a large clinical trial led by Brigham and Women's Hospital researchers, but the drug did not make a significant difference in whether people with coronary artery disease had another heart attack or died, according to a report in tomorrow's Journal of the American Medical Association.

"It does not prolong life, but it provides important relief of symptoms," lead author Dr. David A. Morrow said in an interview.

One of the purposes of the randomized trial, which followed 6,560 patients for almost a year, was to answer questions about whether ranolazine could lead to heart problems, based on differences in heart rhythm noted in the electrocardiograms of people who took it.

The researchers found no difference in the number of heart arrhythmias reported in people who took ranolazine compared to people who took placebos.

In an editorial, Dr. L. Kristin Newby and Dr. Eric D. Peterson of Duke University Medical Center said beta-blockers and nitrates should still be the first drugs to turn to because ranolazine does not improve a patient's prognosis.

"Ranolazine may offer a back-up option for intensification of antianginal treatment if these first-line agents fail," they wrote.

Ranolazine, approved for marketing by the Food and Drug Administration in 2006, is sold as Ranexa by CV Therapeutics, which funded the trial.

Posted by Elizabeth Cooney at 04:42 PM

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Monday, April 23, 2007

Possible bipolar disorder genes found, scientist reports

By Carey Goldberg, Globe Staff

The data are so fresh and preliminary that researchers have not submitted a paper to a scientific journal yet. But Pamela Sklar, a geneticist at the Broad Institute and Massachusetts General Hospital, said yesterday that new genome scans have identified a crop of previously unsuspected genes that -– at first glance, at least -– may be connected to bipolar disorder.

Sklar spoke to the Boston Mental Health Research Symposium at the Boston Harbor Hotel, an event sponsored by NARSAD -– The Mental Health Research Association, a major funder of research on mental illness. The results are far from definitive, she said, and need to be replicated.

Sklar and others are taking advantage of rapid advances in gene-scanning technology to try to find the elusive genes for bipolar disorder –- which is believed to affect about 1 percent of the population -– as well as schizophrenia and other mental illnesses.

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Friday, April 20, 2007

This week in Science

germ 150.bmpThis week's Science includes a special section on germ cells -- the reproductive cells of an organism.

George Q. Daley of Children's Hospital Boston, Brigham and Women's Hospital and the Harvard Stem Cell Institute asks whether the cup is half empty or half full for embryonic stem cells.

David C. Page of the Whitehead Institute and MIT considers the mysteries of sexual identity from the germ cell's perspective.

Alexander F. Schier of the Broad Institute of Harvard and MIT writes about the death and birth of RNAs during the maternal-zygotic transition.

Also in Science, Rachael L. Neve of Harvard and McLean Hospital is an author of a new study in mice about neurons competing to encode a memory in the brain.

Posted by Elizabeth Cooney at 01:03 PM

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Tuesday, April 17, 2007

On the blogs: life-threatening or not, vaccine costs, calling RNA labs

Flea, a Boston-area pediatrician-blogger, answers a vehement "no" to this article's title in Pediatrics: "Do All Infants With Apparent Life-Threatening Events Need to Be Admitted?"

But that doesn't mean they aren't.

"In the real world, evidence-based medicine often doesn't make a dime's worth of difference," he writes. "It doesn't matter to parents and it doesn't even matter to some of Flea's colleagues. This is especially true in the current climate of over-test, over-diagnose, over-treat, and over-admit."

On Kevin, M.D., Nashua pediatrician Dr. Kevin Pho posts a link to the American Academy of Pediatrics' concern about the cost of new vaccines Gardasil, against cervical cancer vaccine ($360), and RotaTeq, against diarrhea-causing rotavirus ($190).

Via Nature Network Boston, Alex Palazzo of Harvard Medical School and the Daily Transcript is putting out the word to 29 RNA labs in the Boston area to meet for a monthly informal data seminar to be called the Boston RNA Data Club. Something like the Boston Area Yeast Meeting at the Whitehead, Nature Network's Corie Lok notes.

Posted by Elizabeth Cooney at 02:16 PM

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Friday, April 13, 2007

This week in PLoS and JCI

gene screen.jpgHarvard researchers including Dr. Todd R. Golub report in PLoS Medicine, the online Public Library of Science journal, that, using a molecular biology technique called microarray expression profiling (an example of a detail is at left), they were able to identify compounds that could target genes involved in Ewing sarcoma, the second most common childhood cancer of bone and soft tissue.

In the Journal of Clinical Investigation, Dr. Alan D'Andrea and colleagues at Dana-Farber Cancer Institute show a new therapeutic target for the treatment of Fanconi anemia, which carries the risk of cancer and bone-marrow failure.

Also in the Journal of Clinical Investigation, Dr. Rong Tian and colleagues from Brigham and Women's Hospital report that in mice, mutations in a protein that triggers cells to generate more energy are associated with heart failure.

Posted by Elizabeth Cooney at 11:02 AM

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Thursday, April 12, 2007

Harvard team identifies protein from a dinosaur

By Colin Nickerson, Globe Staff

Scientists at Harvard Medical School have for the first time isolated and identified protein from a dinosaur -- a Tyrannosaurus rex that perished in Montana 68 million years ago and was partly preserved under tons of sandstone. Some of the protein identified in the Cretaceous era predator match that of modern-day chickens, the research revealed.

The findings, being published tomorrow in the journal Science, upset the long-held assumption that protein and other basic materials of life could not possibly survive in detectable amounts for more than a few hundred thousand years. They also raise the possibility that scientists might eventually recover DNA from prehistoric beasts, allowing for even more sophisticated analyses of ancient organisms and the processes of evolution.

"People are going to be looking differently at prehistoric bones because now we see they may carry tissue and information that nobody believed could still exist," said Mary H. Schweitzer, a paleontologist at North Carolina State University and a coauthor of both articles.

In all, scientists at Harvard were able to isolate seven tiny strips of collagen protein from soft tissue found in the thigh bone of a Tyrannosaurus rex recovered earlier in the decade from beneath 60 feet of sandstone ledge in Montana's Hell Creek formation.

"At the very least, this breakthrough shows we can look at [protein] sequences that are many, many millions of years old," said John M. Asara, director of the mass spectrometry core facility at Beth Israel Deaconess Medical Center and one of the authors. "That's a first."

Paleontologists not involved in the the T.rex protein research said it represented an astonishing piece of scientific sleuthwork.

"This research might be creating a whole new field of molecular paleontology," said Lawrence M. Witmer, a paleontologist at Ohio University. "This research has opened a door we didn't even suspect was there."

But some scientists doubted whether the experiment will have much practical effect on the study of prehistoric life. Many seemed to believe that the surviving soft tissue found in the Montana T. rex was a fluke -- and that there will never be enough material for the sort of fullbore scientific scrutiny that would allow large conclusions to be drawn about the animals.

"If there were regular opportunities for this kind of matching and comparison, [these] techniques might add important evidence to genuine conundrums -- outstanding questions about the origin and relationships of various vertebrate groups," said Farish A. Jenkins Jr., a Harvard professor of zoology and internationally-recognized expert in vertebrate paleontology. "But the reality remains that finding soft tissues preserved with actual soft tissue structure intact is outside the realm of common expectation, so the applicability of their techniques is very limited."

Similar skepticism was expressed by Mark A. Norell, a paleontologist with the American Museum of Natural History: "This is a very cool experiment. But I don't think curators are going to start grinding up their fossil bones to obtain the really minuscule bits of protein that might be available. There probably just isn't going to be enough of this material" to conduct major research.

"Science requires replication," he said. "You need thousands of comparisons. Not dozens."

Still, buzz surrounded the the mind-boggling findings that protein dating back tens of millions of years can be identified at all. Until now, the oldest positively-identified proteins were recovered from the bones of a wooly mammoth reckoned to be a couple hundred thousand years old, according to Schweitzer. DNA has been taken from the 38,000 year-old bones of a Neanderthal, believed to be a prehistoric relative of modern humans.

Several of the T. rex protein snippets captured at Harvard matched sequences in modern chickens, which the authors of the Science articles say lends more credence to the increasingly accepted view among paleontologists that birds are descended from dinosaurs. "We've added molecular evidence to evidence based on the architecture of bones," said Asara.

The research marked an unusual collaboration between field paleontologists -- famous for rough expeditions to remote places in search of rare fossils -- and medical researchers more familiar with finicky lab equipment and computer readouts than sharp pickaxes, smelly sleeping bags, and battered sifting trays.

Lewis Cantley, professor of systems biology at Harvard Medical School and one of the authors, said the techniques used in sequencing the dinosaur protein from minuscule amounts of material could be useful for researchers who need to find the tiny molecular changes that lead to cancer. "We're creating a cross-discipline of biomedical researchers and paleontologists."

The T. rex femur at the center of the research was found in 2003 by John Horner, a paleontologist with Montana's Museum of the Rockies and reknowned fossil hunter. Schweitzer, analyzing the bone, found evidence that the big bone still contained actual bone and vascular tissue. In most preserved dinosaur remains, minerals have replaced all organic matter, the process known as fossilization.

Scientists were quick to discount any suggestion that the sequencing of protein from a T. rex might represent a toddling first step toward cloning dinousaurs, as in Michael Crichton's novel Jurassic Park and the movies that followed. Cloning would require DNA, which deteriorates more rapidly than protein. Collagen, the sort isolated from the t. rex, is a notably durable protein.

"The idea of cloning prehistoric animals from genetic materials remains science fiction," said Ohio University's Witmer. "But keep in mind, until very, very recently, just the idea of obtaining any genetic material at all from animals so old was dismissed as pure science fiction."

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HHMI opens competition for 50 scientists and $600m

At at time when federal funding for scientific research is harder to come by, the Howard Hughes Medical Institute is opening up a competition today to select 50 new investigators who will share $600 million for biomedical research.

For the first time scientists can apply directly to become HHMI investigators rather than needing their institutions to nominate them.

The researchers must belong to eligible institutions. In Massachusetts, 10 qualify: Boston Biomedical Research Institute, Boston College, Boston University, Brandeis University, Harvard Medical School and associated hospitals, Harvard University, the Marine Biological Laboratory, MIT, Tufts University School of Medicine, and the University of Massachusetts Medical School.

The competition comes at a time when funding from the National Institutes of Health, which is based on individual grant proposals, is declining, when inflation is taken into account. Established researchers worry about sustaining their work while younger investigators are taking longer to win approval for their first grant applications.

HHMI, which has spent $8.3 billion over 20 years on biomedical research and science education, won’t be filling that gap, senior scientific officer Dr. Josephine Briggs said in an interview yesterday.

"Our resources are very sizable, but they do not in any way compensate for the problem of the shrinking NIH budget," she said. "The support that Hughes is able to offer is something that the scientific community will of course welcome with delight, but at the same time all of us hope we can see a reversal in the decline in federal funding."

HHMI holds competitions every three or four years. This time, it's looking for people in the earlier stages of their careers, Briggs said.

HHMI investigators receive initial five-year appointments that come with support for their own salaries as well as flexible budgets they can use to pay for personnel and some equipment. Appointments can be renewed.

To be eligible to apply, a candidate must hold a Ph.D., M.D. or equivalent degree; have a tenured or tenure-track position as assistant professor or higher at one of about 200 eligible host institutions; and be the principal investigator on one or more active, national, peer-reviewed research grants at least three years long, such as an NIH R01 award.

The deadline for applications is June 13; expert panels will convene to review them in January, and decisions will be made in March.

"The charge is that they be addressing fundamental and important biological questions. It can be for any discipline, and in this new competition we hope to see chemists, mathematicians, engineers and anybody who’s doing something truly special in addressing biological questions," Briggs said.

"We expect a very hefty Boston response."

Posted by Elizabeth Cooney at 08:10 AM

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Tuesday, April 10, 2007

On the blogs: variations in end-of-life care, manipulating data

On Running a Hospital, Beth Israel Deaconess CEO Paul Levy considers whether the variation in how care is delivered, particularly near the end of life, reflects "overuse, underuse, misuse, and waste in the health care system." He cites a Dartmouth study that said the amount of resources spent didn't change the outcomes, then wonders what should be done. He's gotten 16 answers so far.

On Nature Network Boston, Corie Lok writes about scientific fraud, from ignoring data that don’t fit to falsifying images.

Posted by Elizabeth Cooney at 11:50 AM

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Monday, April 9, 2007

MGH group to study genes and heart attacks

Researchers at Massachusetts General Hospital have won a three-year, $4.2 million grant from the National Heart, Lung and Blood Institute to study genes that may put people at risk for heart attacks, the hospital said.

Dr. David Altshuler, also a founding member of the Broad Institute of Harvard and MIT, and Dr. Sek Katherisan will look at gene variations in 1,500 people who had heart attacks at an early age and 1,500 who did not. They will use data from a study started in 1998 at eight sites, including Mass. General, that make up the Myocardial Infarction Genetics Consortium.

In men under 50 and women under 60, genes may play a greater role in heart attacks, they said. Heart attacks cluster in certain families, regardless of traditional risk factors, but this inherited risk is not explained by gene variants already known to contribute to disease.

Posted by Elizabeth Cooney at 01:52 PM

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Friday, April 6, 2007

This week in Science

mitotic spindle 95.bmpThis week in Science Express, researchers Gohta Goshima, Roy Wollman,
Ronald D. Vale
and Nico Stuurman at the Marine Biological Laboratory at Woods Hole report on a genome screen that revealed about 200 genes -- 150 of them previously unknown or unexpected -- that are involved in assembling the mitotic spindle (left), the structure that separates chromosomes during cell division and plays a role in human diseases, including cancer.

In Science, Young-Sam Lee and Erin K. O'Shea of Harvard take a closer look at inositol pyrophosphates, signaling molecules involved in a number of cellular processes, from gene expression to stress responses.

Posted by Elizabeth Cooney at 08:37 AM

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Wednesday, April 4, 2007

Pregnancy history overlooked in stem cell studies, Tufts researcher says

Stem cell researchers should consider whether a woman has been pregnant when they interpret results of stem cell transplantation trials, Dr. Diana Bianchi writes in a commentary in today's Journal of the American Medical Association.

Bianchi, who is chair of research in the department of pediatrics at the Floating Hospital for Children at Tufts-New England Medical Center, showed in 1996 that fetal cells persist in the blood of women who have been pregnant. In 2004 she reported that these cells appear to act like stem cells, traveling to injured organs in the mother and repairing them.

Fetal cells are "betwixt and between" adult and embryonic cells, she said in an interview. Embryonic stem cells are prized for their ability to become any kind of cell in the body. Adult stem cells are less capable of this kind of differentiation.

"It's not all adult versus embryonic stem cells," she said. "Fetal cells may have qualties that are intermediate between embryonic and adult cells. We are still testing the hypothesis that they have capabilities that may be closer to embryonic stem cells than adult stem cells."

Recent discoveries of stem cells in amniotic fluid-- another "bewtixt and between" situation -- fit in with her findings, she said.

Bianchi and her co-author, Nicholas M. Fisk of Imperial College London, reviewed 58 articles on the long-term fate of stem cells transplanted into sex-mismatched recipients. None of them reported whether the women who donated or received these bone marrow transplants had been pregnant, they write in their commentary.

Without knowing the pregnancy history of women involved in trials using bone marrow stem cells to treat disease, researchers cannot know whether fetal cells or adult cells are responsible for the results they are seeing, Bianchi said.

"It's important because it's a mixed population of the woman's bone marrow stem cells as well as cells from all the pregnancies she has had, including ones she might have terminated," she said. "It's just remarkable to me that this is not part of the paradigm."

Posted by Elizabeth Cooney at 02:01 PM

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Monday, April 2, 2007

Online autism registry seeks to connect families and researchers

Sixty families in Massachusetts were among 750 who tested a pilot version of the Interactive Autism Network, a website designed to accelerate research by connecting families with scientists who study the disorder. The site goes live today.

Julie Riley of Whitman, whose 7-year-old son is autistic, was among the testers during the pilot phase. She urged other parents to join the new network, both to learn from one another's experiences and to find answers for a future in which trial and error aren't the only way to discover what works.

"The more parents we get to participate, the more results we can get," she said in an interview. "I think it's a way to get closer to a cure."

The goal is to have families enter information about their children into a secure database that could be explored by researchers. The site is also designed to help researchers recruit participants for studies that have been approved by their institutional review boards.

There will be a forum for parents as well as information reviewed by doctors for scientific validity, founders Dr. Paul Law and Dr. Kiely Law of the Kennedy Krieger Institute in Baltimore said in an interview. They have a 13-year-old son with autism.

Dr. Margaret Bauman, associate professor of neurology at Harvard and head of the LADDERS program for developmental disorders at Massachusetts General Hospital, was on a committee that worked on the site.

"The hope is this mechanism will match families with researchers and vice versa," she said. "Parents who have been in the world of autism for a couple of years are asking questions."

The IAN project is supported by a $6.5 million grant from the non-profit Autism Speaks.


Posted by Elizabeth Cooney at 08:32 AM

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Urine tests for drug use unreliable, Children's study says

Random urine tests for drug use have a high error rate even when performed in adolescent substance abuse programs, researchers from Children's Hospital Boston report in the April issue of Pediatrics.

Dr. Sharon Levy and her colleagues at the hospital's Center for Adolescent Substance Abuse Research took 710 random urine tests from 110 patients who were 13 to 21 years old and enrolled in a drug program. Comparing the results with those obtained from confirmed laboratory tests, they found that 12 percent of the random tests had results that could be misinterpreted.

Some of the samples were too diluted to interpret reliably. Of the samples confirmed to show Oxycontin use, two-thirds had tested negative at first.

Drug-testing programs demand rigorous procedures and well-trained people to obtain accurate results, the authors conclude.

"'Quick and dirty' drug-testing programs that use procedures of convenience are likely to result in unintended consequences, such as misidentifying some students as using illicit drugs when they are not and enabling others to continue illicit drug use by allowing them to evade detection easily," the Children's authors wrote.

In last month's issue the American Academy of Pediatrics said drug testing of adolescents at home or in school was unreliable and lacked scientific proof of effectiveness.

Posted by Elizabeth Cooney at 06:28 AM

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Wednesday, March 28, 2007

Treatment in doctors' offices works for opioid addiction, CHA study finds

People addicted to opioids such as methadone or oxycodone can be treated in their primary care doctor's office as safely and effectively as at specialized clinics, authors from Cambridge Health Alliance and Harvard Medical School report in the Annals of Family Medicine.

Dr. Ira L. Mintzer and his colleagues studied 99 patients who received the drug buprenorphine-naloxone to treat their opioid dependence at two urban primary care practices: one in a hospital clinic and the other in a neighborhood health center. After six months 54 percent of patients were sober.

Where the patients received their treatment made no significant difference in sobriety, the authors said.

"We hope that our findings will encourage other primary care physicians to consider providing this efficacious form of care," they wrote.

Posted by Elizabeth Cooney at 02:43 PM

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Monday, March 26, 2007

Aspirin linked to lower risk of death in women, but study authors urge caution

Women who regularly took low doses of aspirin had a lower risk of death from all causes, but particularly heart disease and cancer, Harvard researchers report in today's Archives of Internal Medicine.

But it's still too soon to recommend aspirin for the general prevention of disease, the lead author said.

"Women should not take this study, or any study, thus far as a license to take aspirin without any supervision," Dr. Andrew T. Chan of Massachusetts General Hospital said in an interview. "Women need to discuss with their physicians whether it makes sense for them, get a sense of what their risk is for cancer or cardiovascular disease, and strategize with them how to prevent the risk of disease through other means."

Chan and his colleagues looked at 24 years of data from nearly 80,000 healthy women enrolled in the observational Nurses Health Study. Women who said they used aspirin had a 38 percent lower risk of dying from cardiovascular disease and a 12 percent lower risk of dying from cancer. Their overall risk of death was 25 percent lower than women who never took aspirin regularly.

The reduction in cardiovascular disease became apparent after five years and in cancer after 10 years.

The findings conflict with another large study of women and aspirin use called the Women's Health Study. That clinical trial, in which 40,000 women randomly received aspirin or placebo, concluded that aspirin had no effect on mortality, from cardiovascular disease or other causes.

In an editorial, Dr. John A. Baron of Dartmouth Medical School says the nurses study may not have been able to account for the differences between aspirin users and non-users, suggesting women who decide to take aspirin may have better health in the first place.

"These new findings by Chan et al cannot overcome the accumulated evidence that aspirin is not particularly effective for the primary prevention of death from cardiovascular disease in women," he wrote.

Chan responded that he and his co-authors were able to account for health differences among the women in the nurses study because they had detailed information on risk factors. They found that women who were older and had more risk factors for cardiovascular disease were the ones who benefited the most from low to moderate aspirin use, defined as 1 to 14 325-milligram tablets per week.

Higher doses of aspirin have been linked in many studies to gastrointestinal bleeding, the authors noted.

The authors say their study confirms the importance of common mechanisms in both cancer and heart disease, such as inflammation. Aspirin is an anti-inflammatory and inflammation has been implicated in the formation of plaque that blocks arteries as well as in the transformation of normal tissue into cancer.

Proven ways to lower risk of disease are eating a healthy diet, maintaining a good body weight and exercising, Chan said.

"We know those modifications don't have risks," he said.

Posted by Elizabeth Cooney at 04:21 PM

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Contrast agent may shed light on breast cancer diagnosis

Researchers at Beth Israel Deaconess Medical Center and Harvard Medical School are reporting preliminary success with a new way to screen for breast cancer that one day might supplement mammography, according to the American Chemical Society.

resized frangioni.bmp
Crystals resembling those in human breast cancer.

Dr. John Frangioni and researchers in his lab have developed a way to make a contrast agent that after being injected into the bloodstream binds to a particular calcium salt called hydroxyapatite.

That salt is found in malignant micro-calcifications in the breast, but not in benign ones, according to an ACS statement. The contrast agents are designed to be used with optical tomography, an imaging method that sends near-infrared light through the body. Frangioni said it would likely be a few years before the compound is tested in human trials.

Kumar R. Bhushan, a postdoctoral fellow in Frangioni's lab, is scheduled to present the details today at the ACS meeting in Chicago.


Posted by Elizabeth Cooney at 11:20 AM

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Monday, March 19, 2007

Shrinking NIH budget hurts cancer research, Harvard scientist tells Congress

It's dangerous to cut funds for basic research into new cancer therapies just as a tsunami of baby boomers in their cancer-prone years is about to hit, Harvard scientist Joan Brugge told a US Senate appropriations committee today.

She spoke as part of a consortium of nine academic institutions fighting for more funding.

"There's going to be a huge impact in terms of human suffering," she said in an interview. "It's taken a while to understand this complex disease, but now we have a blueprint for how to develop therapies. Now is not the time to retreat."

Every basic science department at Harvard Medical School had at least two or three faculty members whose grants were not funded, she said. Nationwide all grant amounts were cut by 24 percent to 29 percent in 2006.

Read Brugge's testimony below.

First, let me thank Chairman Harkin, ranking member Specter, and members of the committee for this opportunity to report to you some remarkable advances that have occurred in biomedical research because of your strong support for NIH. I hope that I can convey as well my personal excitement for the incredible potential still to be realized in my own field of cancer research. Unfortunately, this enthusiasm is dampened by profound concerns that the four years of flat funding has compromised significantly our ability to fully realize this potential.

When I was a sophomore math major at Northwestern University, my sister was diagnosed with a malignant brain tumor. This event and her subsequent death redirected me towards a career in cancer research. Most of my career has been spent in universities and medical schools. However, for five years before I came to Harvard Medical School, I served as the Scientific Director of a biotechnology company focused on cancer and other diseases. My industry experience significantly shaped my understanding of issues critical to the translation of scientific discoveries into therapies for patients. It taught me among other things, that though the path to treatment can be arduous, today the path between basic discovery and successful drugs also can be remarkably short.

The early 70’s, when I entered cancer research, was a heady time in science. Many of us expected, based in part on the success of the polio vaccine and the Congressionally mandated War on Cancer, that we would soon have a cure for this horrible disease. However, it soon became evident that cancer, unlike polio, is not a single disease with a single cause. There are hundreds of different forms and, indeed, tumors from individual cancer patients carry unique sets of genetic changes. This unexpected complexity – unique to cancer - precluded rapid development of a single vaccine or simple cure.

Though we certainly underestimated the complexity of cancer, the Congressional investment in cancer research is now beginning to pay off. We have made enormous progress in understanding the cause of this disease and its molecular underpinnings. This fundamental information has led to revolutionary approaches to treatment, aimed specifically at the unique vulnerabilities of specific tumors; we now know how to target a tumor’s genetic or molecular Achilles’ heel. In addition, new imaging modalities and biomarkers provide the potential to identify tumors at early stages when treatments are most effective.

Today, I feel a new confidence that we are poised to make more rapid progress in developing effective and less toxic treatments for the myriad different cancers. This confidence is based on initial evidence of success. We now have multiple examples of effective treatments that target the molecular alterations of specific subsets of tumors (such as Tarceva for a subset of lung tumors, Gleevec for chronic myelogenous leukemia, and Tykerb, approved just a week ago for treatment of certain breast cancers). These successes provide a blueprint for the development of treatments for many more types of cancer.

Cancer treatment in the future will involve a molecular diagnosis of each tumor, followed by customized therapies. Already this is being done for breast cancer, in which tumor tissues are probed for several markers that predict which tumors will respond to specific drugs (like Tykerb, Herceptin, or estrogen antagonists) and which will not. The results are dramatic, adding years to the lives of many patients with the most aggressive forms of breast cancer, and sparing patients of treatments that offer no promise of efficacy. For the first time, we are seeing a decrease in deaths associated with cancer. The tip of the iceberg is visible, underneath lies the foundation for a rapid pace of breakthroughs in cancer detection and treatment based on the research investment in the past.

We cannot afford to stand still—the demographics are against us. There is an impending increase in cancer due to the baby boomers aging into their cancer-prone years, which has been referred to as an impending tsunami. You are all keenly aware of the ramifications for government of Medicare entitlements associated with this surge in cancer. But unlike a real tsunami, which comes unexpectedly with no time for preparation, we are well aware of this impending crisis. And We know that the Congressional investment in basic and cancer-focused research has positioned the cancer research community to make more rapid progress in translating basic discoveries into the diagnosis, treatment, and eventually, prevention of cancer. We owe it to the public to capitalize on these investments; failure to maintain the pace of advancement towards reducing the suffering of cancer is not an option the American people should support or will support. We are all in this together.

This brings me to my profound concerns regarding the state of NIH funding today. Four years of flat funding have had a devastating impact on the trajectory of cancer research. We are losing the momentum and the dedicated careers that were fueled by the previous federal investments. We are now damaging the research infrastructure, and this will certainly delay relief from the cancer burden.

While you have seen the statistics regarding grant awards presented by Dr. Zerhouni and others at NIH and are aware of the inflationary erosion of our buying power, the mere numbers mask the profound effects on the research community. I would like to give you an appreciation for what these numbers mean to the cancer research community, which is emblematic of the whole research enterprise. While the eventual success rate of grants is 20%, this number reflects success of either the first, second, or third submission of a grant. The success rate of the first submissions is now about half of this; thus the vast majority of scientists are subjected to a lapse in funding and the negative consequences of this. Not only can a lapse in funding force labs to cut back, let staff go, and redirect efforts to finding alternative funding and resubmission, it creates an environment of insecurity and anxiety that is anathema to the conduct of creative, innovative exploration. Recovery after a 6-12 month funding gap requires retrenching and retraining of new staff. Many leads will never be followed up. Loss of continuity is one of the most serious problems for a scientist. For new investigators, repeated failure to launch their research program is also demoralizing, and discourages taking original and risky paths.

Researchers at all levels are affected —those beginning their careers and senior investigators with long and sustained track records of major discoveries. For example, multiple colleagues at Harvard Medical School who are leaders in their field with outstanding accomplishments, are suffering lapses in funding or losing grants that received priority scores in the 10-20 percentile range. Peer review is too imprecise to distinguish differences in the quality of the grants in this tight range.

Secondly, in order for the success rate of grants to hit the mandated target number of grants, NIH has resorted to cutting grant size dramatically—at NCI, 24-29% (2006). Aggravating this situation are reductions in buying power due to inflation and the 30 percent increase in mandated stipends for graduate students and postdoctoral fellows over the past seven years (an increase that we applaud). Lab directors are faced with carrying their labs at funding levels equivalent to those 7-10 year years ago, at a time when there is a significant increase in cost of the new technologies required for state-of-the-art research. As a result, almost every grant is severely under-funded for achieving the approved goals, and scientists are starving for resources.

The frustration and anxiety of lab directors is not going unnoticed by trainees, and many young scientists are looking for other venues to exercise their talents, ones where their long training investment will not be jeopardized by this lottery in NIH grant review. This has major implications for the science of tomorrow, since we will not be able to fill in the gaps of this lost generation.

I would like to reiterate the long-term implications of the current research budget shortfall on the economy. Cancer incidence for those 65 and older is 10 times greater than for those under 65, and the death rate is 16 times higher. By 2003, 20% of the U.S. population will be over age 65 compared with 12% in 2004. The cost consequences of this tsunami of baby boomers hitting their cancer-prone years could devastate our economy.

A one percent decrease in cancer mortality is reported to be worth $500 billion to our economy according to an NCI report. Getting these potential new therapies I have outlined to patients will take a significant new investment in translational and clinical research, the cost of which can dwarf the cost of basic research. But without the most promising basic discoveries, we will not be able to improve early stage therapies and more and more translational and clinical endeavors will result in dead ends. We can’t be shortsighted.

We recognize the challenges each member of Congress faces in balancing worthy priorities, but I can assure you that from a scientific perspective there is justification for fully supporting basic, translational, and clinical pursuits. Basic science now more than ever fuels the success of effective disease diagnosis, treatment, and prevention in the future.

Through the foresight of the members of this committee and others, the public has generously provided a start toward eradicating one of the scourges of human health. We are in fact in a better place to detect, treat, and potentially, prevent cancer. But just as new therapies based on our cellular and molecular understanding are emerging from our labs, the opportunity to expand them to other types of cancer, to build on them, and to provide for a future of more discoveries has idled. We can’t retreat now that the infrastructure is in place and we are mobilized to launch a full force attack on a disease that we now understand. For the sake of the American people, please find a political route to keep progress against cancer at a sustainable pace. The research findings are clear. There is a path to major advances in cancer detection, diagnosis, therapy, and prevention. Help us get those advances to the public and fulfill the promises of the best in scientific research.

Posted by Elizabeth Cooney at 03:03 PM

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Thursday, March 15, 2007

In Science: HIV evolution is unpredictable

In tomorrow's issue of the journal Science, four researchers from Massachusetts General Hospital -- Nicole Frahm, Toshiyuki Miura, Christian Braner and Bruce Walker -- are among the authors of a paper that says HIV evolution appears to be less predictable than previously thought. They discuss specific ways the rapidly evolving virus changes that may have implications for vaccine design.

Posted by Elizabeth Cooney at 03:59 PM

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Tuesday, March 13, 2007

High-deductible plan cuts ER use, study finds

People who changed their health insurance to a high-deductible plan went to emergency rooms 10 percent less often in the first year than people covered by traditional insurance, cutting down on their visits for such illnesses as colds, headaches and nausea, a study by Harvard Medical School and Harvard Pilgrim Health Care researchers shows.

High-deductible health plans are an important part of discussions in Massachusetts about how to make health insurance affordable as the state implements its new law mandating coverage for all citizens.

Previous studies, including the landmark RAND Health Insurance Experiment conducted almost 30 years ago, showed that making health care more expensive drives down the use of hospitals, medications and prevention services, whether needed or not.

The new study, which appears in tomorrow's Journal of the American Medical Association, came to a different conclusion: "Most HDHP (high-deductible health plan) members did not forgo high-severity emergency department visits and seemed able to distinguish low-severity conditions not requiring emergency department care." Dr. J. Frank. Wharam of Harvard and Harvard Pilgrim is the lead author.

The researchers also wanted to see if the drop in emergency department visits was followed by any change in hospitalizations that might suggest harm from a delay in seeking care. They didn't find such a link, but warn that their study was not designed to pick up this kind of association.

In an editorial commenting on the study, Dr. Corita R. Grudzen of the University of California at Los Angeles and RAND, and Dr. Robert H. Brook of UCLA make the point that a patient can't tell if a headache is serious or not.

"It is inconceivable that high-deductible health plans will not affect the health of some patients," they wrote. "If costs are to be constrained by less generous health insurance, some patients will be harmed."

The study analyzed emergency department visits and hospitalizations afterward among 8,724 people for one year before and after their employers switched from a traditional health-maintenance organization insurance plan to one that had a high deductible. They were compared to 59,557 people who stayed in the traditional HMO plan.

In high-deductible plans, monthly premiums are lower but patients must pay for most medical services, including emergency department visits and hospitalizations, up to a set level. The deductibles for people in the study ranged from $2,985 to $4,008 per year for family plans.

The rate of first visits that patients with high deductibles made to emergency departments wasn't different from those with traditional HMO coverage, but the number of second visits in that year fell 25 percent compared to the control group. That implies that once people get billed for an emergency visit, they are less likely to return, the authors said.

Patients still sought help in the emergency department for severe illness, the study found. But the authors warn that longer follow-up is needed to see if patients who defer care have worse health, particularly if they have low income.

"Our findings imply that, at least in the short term, HDHPs may be associated with reduced overall emergency department utilization without significantly affecting the highest-severity visits," they concluded. "Although we did not detect adverse outcomes, broad decreases in emergency department and hospital utilization raise concerns about long-term effects on health."

Responding to concerns raised in the editorial about harm to patients, Wharam said in an interview that high-deductible insurance plans might be offered by employers who would otherwise offer no coverage at all.

"It's possible that if the employer didn't purchase health insurance, the outcomes could be even worse," he said.

Massachusetts' new healthcare law presents a different case because it targets the uninsured population, he said, making it difficult to extend the study's results to it.

"The attempt to cover all Massachusetts residents is a noble one," he said. "I think the bottom line is that we need more research about how the high-deductible plans affect the behavior and outcomes of patients before making conclusive statements."

The study was funded by the Harvard Pilgrim Health Care Foundation and researchers were supported by federal and medical school grants and fellowships.

Posted by Elizabeth Cooney at 01:06 PM

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Monday, March 12, 2007

Children of long-lived parents have fewer heart risks

If you could pick your parents, you'd be wise to choose ones who live long and have few risk factors for heart disease. But don't lose hope if your parents died young -- you still can lower those risks yourself, researchers from the Framingham Heart Study say.

Results published in tomorrow's Archives of Internal Medicine show that middle-aged children who had at least one parent who lived to age 85 were less likely to develop high blood pressure, high cholesterol and other risk factors for cardiovascular disease than people whose parents died younger.

Other research has connected longevity to heredity, but this multigenerational study showed that having fewer risk factors for cardiovascular disease, the leading cause of death in Americans, was an advantage that lasted. The Framingham Heart Study has followed generations of residents since 1948 to study cardiovascular and other chronic diseases. This latest analysis included 5,124 people who were examined every 4 to 8 years from 1971 to the present.

"If you weren't lucky enough to choose your parents, this study shows how some of destiny is determined by risk factors we already know about and know to be modifiable," study co-author Dr. Daniel Levy, director of the Framingham Heart Study and a member of the National Heart, Lung and Blood Institute, said in an interview. "We know that if we eliminate high blood pressure, eliminate high cholesterol and then cigarette smoking, we would eradicate the overwhelming majority of cardiovascular disease in the United States."

People in mid-life shouldn't wait for signs of trouble to take steps to lower their blood pressure and cholesterol, said study co-author Dr. Emelia J. Benjamin, a professor of medicine at Boston University School of Medicine and a cardiologist at Boston Medical Center.

"Clearly there is a genetic basis to longevity but what this says is, some of the basis has to do with risk factors," she said in an interview. "You don't have to say, 'My parents died young so I can't do anything about it.' What this suggests to me is, 'Why don't you change the risk factors?' "

In an editorial about the article, Dr. Clyde B. Schecter of Albert Einstein College of Medicine asks whether cardiovascular disease is just postponed in long-lived people or if longevity might be a factor in whether people survive cardiovascular disease.

"Heart disease accounts for a large enough proportion of all deaths that any factor that promotes exceptional longevity almost inevitably must lead to decreased risk of cardiac death," he wrote.

The Framingham researchers, funded by NHLBI and NIH, are pursuing answers in the genes. A genome-wide scan of participants across the generations in the study began last fall with genotyping that Levy expects to be completed by the end of the summer.

"Longevity may be related to risk factors we don't yet know," he said. "We intend to look at the genetic variations that may differentiate children whose parents live to an old age from children whose parents died at a young age."

Posted by Elizabeth Cooney at 04:01 PM

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Wednesday, March 7, 2007

McLean leads large trial of treatment for pain-pill addiction

McLean Hospital in Belmont will lead the first large-scale study of a treatment for people addicted to pain medications such as Vicodin and OxyContin, the National Institute on Drug Abuse announced today.

Researchers will recruit 648 participants at 11 sites, hoping to enroll both people who have taken prescription medications for pain relief but later became addicted, as well as people who take the drugs illicitly for nonmedical reasons. People interested in participating can call (617) 855-2588.

Study subjects will receive a drug called buprenorphine naloxone, sold as Suboxone, which was approved by the U.S. Food and Drug Administration in 2002 as an alternative to methadone treatment for people addicted to opiates such as heroin.

"The major contribution of this study is that it’s focusing on this specific problem of prescription opiate dependence," Dr. Roger Weiss, clinical director of McLean Hospital’s Alcohol and Drug Abuse Treatment Center and lead investigator for the study, said in an interview. "Most studies that have looked at opiate dependence have been done on heroin addicts with a sprinkling of people with prescription opiate dependence."

Over the past five to 10 years, the number of people dependent on these prescription pain drugs has grown substantially, Weiss said.

The 2005 National Survey on Drug Use and Health found that 2.2 million Americans aged 12 or older reported being new users of pain relievers for nonmedical purposes, surpassing the 2.1 million new marijuana abusers. In 2005, more than 6 million Americans in all reported nonmedical use of prescription drugs in the past month -- more than the number abusing cocaine, heroin, hallucinogens, and inhalants, combined, according to a statement from the National Institute on Drug Abuse.

"You have adolescents and young adults who have become dependent on prescription opiates, and you also have people of middle age and older," Weiss said. "We don’t really know whether the treatment strategies that we’ve learned are successful for heroin addicts are the same for people with prescription opiate dependence."

Weiss said the researchers also wonder whether the treatment will have the same results for the 40 percent of people who have chronic pain and are dependent on the drugs as for those who take the drugs illicitly.

Most participants will take Suboxone for between three and nine months. They will also be enrolled in one of two different behavioral therapies to test how well they work with the medication. Results are due to be reported in 2009.

Posted by Elizabeth Cooney at 06:10 PM

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Monday, March 5, 2007

Is superhero syndrome epidemic?

Blog, MD raises public awareness about a new threat to children's health in a recent post. He highlights a study in the current Archives of Disease in Childhood that reports on serious injuries to five British children wearing superhero costumes.

"The children we saw have all had to contemplate on their way to hospital that they do not in fact possess superpowers," wrote the authors. Four of the children wore Spiderman costumes, and the fifth a Superman outfit. "They were injured after initiating flight without having planned for landing strategies."

"Brilliant. Only the British can make something like this so amusing," comments Blog, MD, who under his blogger disguise is Dr. Samuel Blackman, a Boston pediatric oncologist.

"The authors indicate that while they are strong advocates of adventurous play and while they also understand that risk-taking is an integral part of childhood, they caution that parents need to be aware that children may believe that their abilities 'have been given a super-boost' with an appropriate costume," Blackman writes.

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Depression often disabling and untreated among blacks

Lifetime rates of major depression are higher among whites, but depression is more likely to be severe and disabling among African-Americans and Caribbean blacks, according to a study in the March issue of the Archives of General Psychiatry. Fewer than half of African-Americans and fewer than a quarter of Caribbean blacks got any kind of therapy for their major depression.

Data on treatment was not collected for whites, the article said, but the national average for treatment of major depression among adults is 57 percent.

"These data suggest that when blacks develop major depressive disorder, it is likely debilitating in impact and persistent in its course," wrote lead author David R. Williams of the Harvard School of Public Health. "These findings underscore the pressing need to understand the factors underlying racial differences in access and quality of mental health care and the urgency of implementing interventions to eliminate these disparities."

The researchers studied major depression among 6,082 people in the National Survey of American Life, the largest study of mental health in the U.S. black population. They looked at results from face-to-face interviews followed by telephone calls with 3,570 African-Americans, 1,621 Caribbean blacks and 891 non-Hispanic whites from 2001 through 2003.

More whites (17.9 percent) than African-Americans (10.4 percent) and Caribbean blacks (12.9 percent) said they had experienced major depression over their lifetimes, but among those who had, more African-Americans (56.5 percent) and Caribbean blacks (56 percent) reported episodes in the past 12 months compared with whites (38.6 percent.)

This is the first psychiatric epidemiologic study of blacks in the United States to include a large national sample of Caribbean-origin blacks, the authors said.

Kristin N. Javaras, a biostatistician who studies mental health data at the Harvard School of Public Health and McLean Hospital, said the study's findings are valuable because they confirm in a larger population work that had been done in smaller groups. Studying African-Americans and Caribbean blacks as separate groups was also important.

"They also assessed the severity of the depression and the percentage of people getting treatment," said Javaras, who was not involved in the study. "It suggests that perhaps black Americans have less access to treatment, which could explain the increased chronicity."

Study co-author Harold W. Neighbors said in an e-mail interview, "The most important next step is to figure out ways to get more black Americans (both African-Americans and Caribbean blacks) with depression into professional care."

Responsibility rests on both the consumer and professional side for decreasing barriers to care for depression, wrote Neighbors, director and research professor in the Program for Research on Black Americans at the University of Michigan's Institute for Social Research.

"More open and honest discussion among black Americans within smaller friendship networks about their struggles with depression should lift some of the social stigma associated with depression," he said. "But we also need more effective educational programs that will help mental health clinicians establish rapport with black patients and others from cultural backgrounds that differ from the prototypical patient who too often is a white American."

The article said more research needs to be done on the social support systems, including religious activities, and individual strengths, such as self-esteem, that may account for lower levels of lifetime major depression. Further work is also needed to understand why, when severe depression occurs, it is more persistent and disruptive among both African-Americans and Caribbean blacks, the authors said.

Dr. Timothy G. Benson, a psychiatrist at McLean Hospital who lectures on African-American health disparities, said he was excited to see the report put the issue back in the forefront. He was not involved in the study.

"This gives us a gauge to see that what we are doing right now is not sufficient. There is a significant gap in access to care," he said. "What I hope to see are more papers on strategies on how to eliminate these disparities."

Posted by Elizabeth Cooney at 04:00 PM

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Faculty of 1000 Medicine interprets research

A new online research tool called The Faculty of 1000 Medicine aims to help researchers and clinicians make sense of the flood of scientific information available online. Tomorrow its 100 Boston members are invited to Dana-Farber Cancer Institute to discuss how its interpretive approach can help speed research advances along the path to patient care.

"The thing that's missing from a lot of online publications is the role of interpreter who is an expert in the field and who objectively puts things in the right perspective," Dr. Edward J. Benz, president of Dana-Farber and one of the hematology editors for the online resource, said in an interview. He and Dr. M. Rashad Massoud, senior vice president of the Institute for Healthcare Improvement, will speak at the 4 p.m. reception.

In his role as an editor, Benz gathers colleagues who are experts in particular areas of hematology such as anemia or clotting disorders, relying on them to track their specialties and compile packets of information online. Users can supply keywords that will be used to send them notices of articles they might find interesting. Other editors do the same thing in other fields of medicine, sometimes writing commentaries or pointing to key points that may be overlooked.

"This is one of the many ways people are trying to accelerate the conversion of research knowledge into clinical practice," Benz said. "A multi-disciplinary awareness is important for seeing where the clues are that might not ordinarily appear in front of you if you keep your head down in your own area."

Boston has a high concentration of medical experts, but that doesn't mean they always see one another face to face, Benz said.

"The nice thing about the Web is you can do a lot of work from your desk, but you often don't meet the people who work in other fields," he said. "They might be three hospitals away. So this can be a way to get together face to face."

Posted by Elizabeth Cooney at 11:28 AM

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Thursday, March 1, 2007

Snub of the universe? Postdocs pick elsewhere

Not a single institution on either side of the Charles cracked the Top 15 places to work in a survey of postdoctoral life scientists, the March issue of The Scientist magazine says.

Training and experience matter the most to these researchers, who have finished their Ph.D.s but don't have faculty positions, the survey reports. They ranked access to books and journals next, followed by affordable medical insurance and then equipment and supplies for research.

The closest Boston or Cambridge came was Beth Israel Deaconess Medical Center's 28th-place finish, shooting up from 97th last year.

Harvard Medical School, Brigham and Women's Hospital, Woods Hole Oceanographic Institute and Dana-Farber Cancer Institute also made the top 40. MIT dropped out of the top 40, placing 53rd.

M.D. Anderson Cancer Center in Houston topped the list, zooming up from 29th last year. The J. Gladstone Institutes in San Francisco slid to second place from first. The U.S. Environmental Protection Agency in Research Triangle Park, N.C., stayed in third.

Here's how postdocs ranked area institutions, with the 2006 ranking in parentheses:

Beth Israel Deaconess: 28 (97)
Harvard Medical School: 31 (17)
Brigham and Women's: 35 (41)
Woods Hole: 38 (11)
Dana-Farber: 39 (67)
MIT: 53 (26)
Harvard University: 71 (45)
Massachusetts General Hospital: 81 (64)

A total of 96 institutions in North America were ranked this year. Research centers with too few responses were not listed, including some in the Boston area.

For its "Best Places to Work 2007: Postdocs," the magazine polled its readers about conditions in their research facilities. The Web-based questionnaire pulled in 2,555 usable responses from people who identified themselves as non-tenured scientists working in academia or other non-commercial research organizations.

So, postdocs, White Coat Notes wonders what you think about where you work. Send us your thoughts at whitecoat@globe.com.

Posted by Elizabeth Cooney at 08:03 AM

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Wednesday, February 28, 2007

Managing chronic disease at community health centers

Researchers from Harvard Medical School assessed the effectiveness of the Health Disparities Collaboratives, a group set up to help community health centers improve the quality of their care. The collaboratives improved care for patients with diabetes and asthma but not for those with hypertension, Dr. Bruce E. Landon and colleagues report in tomorrow's New England Journal of Medicine.

Posted by Elizabeth Cooney at 05:00 PM

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Tuesday, February 27, 2007

High-fat dairy foods may help some women get pregnant

Women having trouble getting pregnant because they aren't ovulating regularly may want to drink a daily glass of whole milk and skip the skim, according to a Harvard study appearing in tomorrow's issue of the journal Human Reproduction.

Dr. Jorge E. Chavarro and his colleagues at the Harvard School of Public Health followed 18,555 women in the Nurses Health Study II for eight years. They found that eating low-fat dairy foods may increase the risk of infertility from a lack of ovulation by 85 percent while eating high-fat dairy foods may decrease the risk by 27 percent.

The findings are important in light of government recommendations to consume three or more daily servings of low-fat milk or other dairy products, the article says, calling it a "strategy that may be deleterious for women planning to become pregnant."

For both high-fat and low-fat foods, the effects showed up with only one or two servings per day, Chavarro said.

"The women in the study really did not consume that much high-fat dairy food, but the level they did had some protective effect at about one serving a day, especially for whole milk and to a lesser extent for ice cream," Chavarro said in an interview. "It was not really high, not going crazy with buckets of ice cream after every meal."

Lack of ovulation is a significant cause of infertility, affecting as many as 1 in 3 women who have difficulty conceiving, said Dr. Alan Penzias, director of the reproductive endocrinology fellowship at Beth Israel Deaconess Medical Center and a professor of obstetrics and gynecology at Harvard Medical School. He was not involved in the study.

A number of conditions, including big swings in weight, can shut down ovulation. If a woman has gained weight recently, she is typically told to go on a diet, he said. But now that advice may be adjusted when it comes to dairy foods.

"Instead of just telling them, lose weight, we may then modify some of our advice," he said. "We may say, 'While trying to have a well-balanced healthy diet, you may want to avoid an excess of low-fat dairy foods.' "

Chavarro said dairy fat -- or something in dairy fat -- is responsible for the benefit. Hormones from cows that are soluble in fat may have an impact on fertility, but further studies will have to be done to be sure, he said. The study also looked at calcium, phosphorus and vitamin D but found no connection to infertility.

Should doctors order ice cream for their patients?

"Ice cream may be great for sensational headlines, but it's not the best dietary advice," Penzias said.

Posted by Elizabeth Cooney at 07:00 PM

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Monday, February 19, 2007

We're 'wired to connect,' MGH research shows

We know what it feels like to sense a connection with another person. It's called empathy.

But researchers from Massachusetts General Hospital wanted to measure biologically the experience we have when we feel understood and connected with somebody. They studied interactions between patients and their psychotherapists, whose job is to be empathetic.

Using skin sensors that measure arousal and observers' reactions to videotaped therapy sessions, they found that the more therapists and patients felt the same, the more connected they seemed to be and positive about the relationship. The study appears in the February Journal of Nervous and Mental Diseases.

"When we feel like we are really connected, we literally are in tune with others," said Dr. Carl D. Marci, director of social neuroscience at Mass. General. "This supports brain imaging data that shows humans are literally 'wired to connect' emotionally."

The 20 patient-therapist sessions suggested that shared positive emotions and shared physiological responses create an empathetic connection.

How therapists engage with their patients can play a huge role in the outcome of therapy, Marci said, so these findings can help therapists do a better job.

One other factor was important: Patients and therapists seemed more in tune when the therapist was listening.

"It's very hard to be empathetic when you are talking," he said. "Talking is engaging an altogether different part of the brain to think about what you are saying. You sort of shut down or dampen this emotional response we have."

Posted by Elizabeth Cooney at 08:11 AM

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Wednesday, February 14, 2007

Sex makes young people feel good. So?

Young people feel better after sex.

Not earth-shattering news, you say?

Children's Hospital Boston researcher Dr. Lydia A. Shrier, lead author of a study that reached that conclusion, understands why you'd react that way, but hear her out. She says that until we know what adolescents really think about sex, anyone trying to help them have safer sex -- or no sex -- might be wasting their time.

"If we don't understand exactly how they feel around the time of sex, we're going to miss the boat with our risk reduction or abstinence messages," said Shrier, whose study appears in the Journal of Adolescent Health. "We all know that feelings are very much connected to how we behave."

To assess young people's emotions, Shrier's team gave hand-held computers to 67 adolescents and young adults, 15 to 21 years old, and randomly beeped them at least every three waking hours for a week. A message would then pop up on the participants' PDAs asking them how they were feeling and whether they had had sex since the previous page. To be in the study, the young people had to say they were sexually active.

That's different from asking people what they think about sex or to remember later what they felt like at the time, Shrier emphasized. This nearly real-time report of how they felt makes the study different from previous work, including her own, she said.

"We examined real events in these kids' lives as they were happening. We didn't ask them to recall things or to select out a particular thing," she said. "We asked them to monitor themselves with computers and respond to signals, so we were getting what was actually going on."

The study also stands apart from surveys that asked adolescents their feelings about their first sexual experiences, which tended to be more negative than what the researchers found this time.

Policy makers need to pay attention, Shrier said.

"Without taking a political stance, I'd just say we all want people to ultimately be sexually healthy adults, whatever our beliefs are," she said. "And whether we want kids to reduce sexual risk or be abstinent, we have to understand the feelings of the young people having sex."

Posted by Elizabeth Cooney at 05:12 PM

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Children's study: Steroids no help for Kawasaki disease

Children with Kawasaki disease are at risk for developing
coronary-artery aneurysms. Standard therapy includes giving these children intravenous immune globulin and aspirin. A study in the New England Journal of Medicine, led by Dr. Jane W. Newburger of Children's Hospital Boston and Harvard Medical School, shows that adding a single pulsed dose of intravenous methylprednisolone did not produce better outcomes than the standard therapy.

Posted by Elizabeth Cooney at 05:00 PM

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Tuesday, February 13, 2007

Three-quarters of impaired doctors recover, study says

Three-quarters of Massachusetts physicians being monitored for substance abuse or mental and behavioral health problems successfully completed their programs while continuing to practice, a study by the Massachusetts Medical Society's Physician Health Services program found.

The success rate was nearly identical for both types of disorders, showing that techniques developed for helping physicians with substance abuse can be applied to other problems, the authors reported in the Journal of Psychiatric Practice. But they also found that women fared worse than men.

"We thought men and women would do equally well," said Dr. John R. Knight of Harvard Medical School and Children's Hospital Boston. "We don't know the exact reasons the women did so poorly. It's really going to require a new look at our program, and I think we've got to consider offering new services for women physicians."

Overall results showed that 75 percent of doctors with substance abuse disorders and 74 percent with mental and behavior problems met all the requirements of the medical society's monitoring program. But women relapsed significantly sooner than men and only 62 percent of women physicians were successful, compared with 78 percent of male physicians.

Five members of the Physician Health Services program, including Knight, looked at 10 years of records for 58 physicians with mental and behavioral problems, such as depression or bipolar illness, and 120 with substance abuse disorders who agreed to monitoring by the program. They were followed for at least three years.

Monitoring included oversight by other physicians they worked with, meetings with supervisors, and drug tests for those with substance abuse problems. Physicians who also had dealings with the state licensing board had a higher success rate than others, especially when substance abuse was involved.

Nancy Achin Audesse, executive director of the state Board of Registration in Medicine, was encouraged by the report.

"I think it is very good news that we have a system in place to identify physicians who are in trouble, to handle them, and to help them back to recovery," she said. "When we have these experienced and capable doctors and they end up with health problems, we don't want to lose them from practice. We want to get them back into healthy practice."

Posted by Elizabeth Cooney at 06:45 PM

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Monday, February 12, 2007

Drug-coated stents no better than older models, studies show

By Stephen Heuser, Globe Staff

The most exhaustive studies yet published on drug-coated stents show that the widely used heart devices are no better at preventing heart attacks and death than the older, cheaper devices they replaced, and in some cases may be slightly worse.

A series of studies released today by the New England Journal of Medicine showed that drug-coated stents carried one clear benefit: patients who receive them are less likely to return to the hospital for a repeat heart-clearing procedure.

Viewed over the long term, however, the stents did not improve patients' survival rates.

Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center who chairs the FDA's panel on cardiovascular devices, said the new studies would likely push doctors to be more cautious about using drug-coated stents. "The decision to put in a drug-eluting stent is now a decision, where before it was used in almost any case," he said.

Click here for full story.

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MIT research IDs tumor defense mechanism

MIT scientists have identified a new defense mechanism that tumor cells use to survive chemotherapy, a discovery that could lead to drugs that make existing cancer drugs work better at lower doses.

Writing in the cover story of today's Cancer Cell, Dr. Michael B. Yaffe and his biomedical engineering colleagues explain that once tumors lose their ability to repair DNA that has been damaged by drugs or radiation, they turn to a signaling pathway involved in inflammation in order to survive.

"The exciting thing is we can now target this pathway," said Yaffe, who is also a surgeon at Beth Israel Deaconess Medical Center and affiliated with the Broad Institute of Harvard and MIT. "It won't make normal cells any more susceptible to chemo but it will make cancer cells much more sensitive."

The scientists tested their idea by turning off the inflammation pathway in mouse tumors. After they gave low doses of the common cancer drug cisplatin to the mice, their tumors melted away, Yaffe said.

A drug that works against a molecule important in inflammation called MK2 is already being tested. Originally conceived as a treatment for arthritis, it may be modified to thwart just the inflammatory pathway that cancer cells use to survive.

"Our results suggest it might have a second life in helping to treat cancer patients," Yaffe said. "It could mean standard chemotherapy would suddenly become much more effective."

Posted by Elizabeth Cooney at 12:00 PM

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Narrowing the search for cancer genes

The road to personalized medicine is a bumpy one, but researchers at the Dana-Farber Cancer Institute and the Broad Institute have found a method that might smooth the way.

Writing in yesterday's Nature Genetics, they report on a faster, cheaper method of screening for multiple mutations that turn on cancer genes.

Taking advantage of mass spectrometry, a tool researchers use to detect variations in genes, they were able to narrow down their search for relevant mutations in 1,000 samples of tumor tissue by examining only regions of genes where most troublesome mutations occur.

"You don't have to sequence the entire cancer genome," said Dr. Levi A. Garraway, a medical oncologist at Dana-Farber and an associate member of the Broad, a joint MIT-Harvard institute. "All you need to do is look in specific locations."

The researchers discovered that some tumor samples showed mutations not normally expected for the kind of cancer the patient had been diagnosed with. If a patient with pancreatic cancer showed a mutation more commonly found in lung cancer, for example, there might be a treatment to use that would not otherwise have been considered, Garraway said.

The screening method could be used along with the Cancer Genome Atlas, a large, complex project to sequence cancer genes.

There are two barriers to making individualized cancer medicine a reality, the paper says. One is to identify all the genes involved in the spectrum of cancers, and the other is to translate that knowledge into therapies for patients.

"We're trying to pave a way to get past both bottlenecks," Garraway said.

Posted by Elizabeth Cooney at 06:00 AM

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Thursday, February 8, 2007

Cancer patients' spiritual needs unmet, study says

Nearly three-quarters of patients with advanced cancer felt their spiritual needs were not met by the medical system, including chaplains, a survey by Harvard researchers shows. Nearly half of the patients thought their religious communities gave them little or no support.

People who had spiritual support tended to have better quality of life, according to the Coping With Cancer study, based at Dana-Farber Cancer Institute. And people who described themselves as religious were twice as likely to want more aggressive treatment to extend their lives, it said. The survey of 230 patients is reported in Saturday's Journal of Clinical Oncology.

"These findings provide further evidence that oncology practitioners really should include a spiritual history as part of a patient's history of social support and culture," Dr. Tracy A. Balboni said in an interview today. She is a senior resident in the Harvard Radiation Oncology Program and the paper's lead author. "It allows the practitioner to know whether something's important to the patient and also makes the statement, 'We understand this might be an important part of dealing with your illness.' "

Most of the people in the study (88 percent) said religion was at least somewhat important to them. More African Americans (89 percent) and Hispanics (79 percent) than whites (59 percent) said it was very important.

As people got sicker, they were less able to attend religious services. Just over half (52 percent) reported getting visits from chaplains or other clergy members.

Most patients (72 percent) said the medical system offered little spiritual support, and 47 percent said the same about their religious community.

Physicians may be leery of overstepping their bounds by asking their patients about religion, the authors wrote. In an accompanying editorial, Betty Ferrell, a research scientist in the City of Hope Cancer Center's department of nursing research and education, urges doctors to take a different approach.

"This report is a strong statement of a seriously unmet need in the vast majority of patients in our care," she wrote. "The oncologist who dares to ask about spirituality imparts a vital message to patients that they are being cared for by someone who has not forgotten that a broken patient remains a whole person, and that healing transcends survival."

Posted by Elizabeth Cooney at 06:00 PM

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Wednesday, February 7, 2007

Conscience and controversy in the doctor's office

Most physicians believe it is ethically acceptable to tell patients if they find a legally available medical procedure morally objectionable, but most also feel obligated to present all treatment options and refer patients to other clinicians who don't share their opposition, according to a nationwide survey being published in tomorrow's New England Journal of Medicine.

The physicians were asked how they would respond to requests for treatments such as sedation for dying patients to make them unconscious; abortion after failed contraception; and prescribing birth control to adolescents without their parents' permission.

"Many physicians do not consider themselves obligated to disclose information about or refer patients for legal but morally controversial medical procedures," concluded the authors from the University of Chicago. "Patients who want information about and access to such procedures may need to inquire proactively to determine whether their physicians would accommodate such requests."

Male physicians and those who describe themselves as religious were most likely to say they would express personal objections and least likely to say they would disclose information about procedures they found objectionable or refer patients to providers who don't share their views, the study concluded.

The researchers randomly surveyed 2,000 doctors by mail. Of the 1,144 who responded, 63 percent said they thought it was permissible to state their moral objections, 86 percent felt physicians are obligated to present all options to their patients, and 71 percent believed they are bound to refer patients to another provider who does not object to the procedure on moral grounds.

That could mean 14 percent of patients, or more than 40 million Americans, may have doctors who do not feel ethically bound to disclose information about treatments they find objectionable, the authors wrote. And 29 percent of patients, or nearly 100 million Americans, may be cared for by doctors who do not feel they must refer patients to another doctor who would provide the service the patient requests.

The study found that 52 percent of physicians object to abortion for failed contraception and 42 percent object to contraception for adolescents without parental approval.

Patients need to be aware that their doctors might not agree with them or feel they should discuss alternatives, said Dr. Farr A. Curlin, a general internist and ethicist at the University of Chicago.

"The only resolution that is going to be workable is to have a respectful negotiation" between doctors and paients, he said in an interview today. "Doctors need to be up-front and candid with their patients about their boundaries so they can work out accommodations as best they can."

Posted by Elizabeth Cooney at 05:18 PM

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Horse genome sequenced by Broad team

The first draft of the horse genome sequence has been completed by scientists at the Broad Institute in Cambridge, work that has implications for the study of human disease, the National Human Genome Research Institute announced today.

A team led by Kerstin Lindblad-Toh at the joint MIT-Harvard institute began sequencing the domestic horse genome in 2006, culminating a 10-year effort by international scientists called the Horse Genome Project.


twilight.jpg
Twilight, the mare whose genome was sequenced.

The horse whose DNA was used is a Thoroughbred named Twilight from Cornell University. Research done there by Doug Antczak has implications for research on reproduction, clinical organ transplantation and immune regulation, according to the NHGRI.

Posted by Elizabeth Cooney at 10:54 AM

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Funding concerns hit some cancer trials

The 10 federally funded Coalition of Cancer Cooperative Groups, which enroll nearly half of the patients in the nation who are participating in cancer trials, have begun to shut down trials and stop studying certain cancers amid funding concerns, according to a report in today's Wall Street Journal.

About 3,000 patient spots in clinical trials will be eliminated in 2007 at centers around the U.S., the group said. Although the decrease will affect all cancers, among the hardest-hit will be rarer cancers.

Posted by Elizabeth Cooney at 09:42 AM

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Tuesday, February 6, 2007

Nominee for 'paper of the year'

An article by Dr. Thomas A. Gaziano of Brigham and Women's Hospital and Harvard Medical School, Lionel H. Opie of the University of Cape Town, and Milton C. Weinstein of the Harvard School of Public Health was among 23 original research articles nominated for "Paper of the Year 2006." Editors of the Lancet for the past three years have winnowed biomedical papers -- 700,000 in last year's case -- to pick the best medical research of the year.

The Gaziano paper was "Cardiovascular disease prevention with a multidrug regimen in the developing world: a cost-effectiveness analysis."

The winners for 2006 were trials of two rotavirus vaccines, published in the New England Journal of Medicine.

Posted by Elizabeth Cooney at 06:27 AM

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Monday, February 5, 2007

Turning off the TV won't make kids more active

Cutting down on how much television adolescents watch doesn't necessarily translate into more physical activity, Harvard researchers report in today's issue of Pediatrics.

"Kids have other activities that they do if they turn off the TV," said Dr. Matthew W. Gillman, a professor at Harvard Medical School and director of an obesity prevention program at Harvard Pilgrim Health Care. "They don't necessarily go out and play or join a sports team."

Researchers tracked 10,000 10- to 15-year-old boys and girls for four years, asking them to report their TV habits and physical activity levels. The results ruled out any major association between the two.

Programs that work on sedentary behaviors like TV watching and physical activity as separate, independent elements hold more promise for helping children avoid excess weight during adolescence, the authors concluded.

They noted that adolescents may gain weight if they watch a lot of television because of what they also do in front of the TV set. There's some evidence that kids who watch TV ads for unhealthy foods wind up eating more of them. Or they just snack while they watch.

"If we want to get the greatest bang for our buck in terms of interventions to prevent obesity, we're going to have to work on both TV and physical activity independently," Gillman said.

Posted by Elizabeth Cooney at 06:00 AM

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Friday, February 2, 2007

Predicting which drugs will make it

To develop more successful drugs, you have to look at both the winners and the losers. But that means drug companies need to share their gold mine of information on unsuccessful medicines, two researchers from Children's Hospital Boston's Informatics Program say.

Based on information about failed drugs, Dr. Asher D. Schachter and Marco F. Ramoni say they can predict which drugs in early development will be safe and effective.

They make that case in the February Nature Reviews Drug Discovery, saying their model could help save $283 million per approved drug.

"Suppressing negative data harms everyone," Schachter said. "Companies could reduce drug development costs and pass on some of those savings to the consumer."

Schachter and Ramoni just founded Phorecaster, a consulting business that has no customers or profits yet.

Schachter, a pediatric nephrologist, said to create their forecasting model they looked at data about early-stage drugs described in publications from the Tufts Center for the Study of Drug Development and other public sources.

They were able to predict success in phase 3 trials and new-drug-application approval with 78 percent accuracy, they said.

Posted by Elizabeth Cooney at 02:31 PM

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Today's Globe: post-concussion syndrome, pancreatic cancer stem cells, pandemic rules, breast implants

Plagued by post-concussion syndrome and battling an amphetamine addiction, former Patriots linebacker Ted Johnson is a shell of his former self.

Researchers at the University of Michigan have discovered a small population of stem cells in pancreatic cancer that appear to drive tumor growth, opening the door for a potential new approach for treating this particularly deadly disease.

The CDC's pandemic guidelines mean states should be prepared to keep children out of school for three months, businesses should be ready to operate with skeleton workforces, children should be prepared to play mostly with their siblings, and parents should be ready to lose income as they skip work and cobble together child-care arrangements.

Despite FDA approval, breast implants are still not safe, Dallas plastic surgeon Dr. Edward Melmed and Our Bodies Ourselves executive director Judy Norsigian write in an op-ed piece.

Posted by Elizabeth Cooney at 06:27 AM

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Thursday, February 1, 2007

Binge eating is the most common eating disorder, McLean study shows

Binge eating disorder affects more American adults than anorexia and bulimia combined, a study from McLean Hospital and Harvard Medical School finds, making it a "major public health problem."

Binge eating behavior also tends to last longer, spanning about eight years compared with an average of 1.7 years for anorexia, the Harvard authors write in Biological Psychiatry.

About 5.9 million people in the United States could have a binge eating disorder at some point in their life, Dr. James I. Hudson and his co-authors say. That compares with 1.3 million cases of anorexia and 2.1 million cases of bulimia, based on data from the National Comorbidity Survey Replication. The survey asked 9,000 people across the United Sates about their mental health.

Binge eating, defined as repeated bouts of uncontrolled eating, appears to be a cause for severe obesity. People with anorexia fear being overweight so much that they eat very little. Bulimics overeat but vomit after to avoid weight gain.

Binge eaters continue to gain weight, becoming morbidly obese, with a body mass index of 40 or greater. For a 5-foot-6-inch woman, that BMI would mean 248 pounds; for a 5-foot-9-inch man, 270 pounds.

"If we can identify and treat the underlying cause of this behavioral disturbance, we may be able to make an impact on the obesity epidemic," Hudson said. "This is a major public health problem."

Hudson reported receiving funding for the eating disorders analysis from OrthoMcNeil Neurologics, which has tested its antiepilepsy drug, topiramate, for effectiveness in binge eating disorder.

The national survey's funders included Eli Lilly and Co.

Posted by Elizabeth Cooney at 07:08 AM

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Today's Globe: case against Haddad, oils and breast growth in boys

A woman who worked for the state's largest Catholic hospital chain for 20 years filed a sexual harassment complaint against former Caritas chief executive Dr. Robert Haddad. In it she spells out what she said occurred over 15 months and ended when she was laid off, allegedly in retaliation for complaining to hospital executives.

Lavender and tea tree oils found in some shampoos, soaps, and lotions can temporarily leave boys with enlarged breasts in rare cases, apparently by disrupting their hormonal balance, a preliminary study suggests.

Posted by Elizabeth Cooney at 06:26 AM

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Wednesday, January 31, 2007

Air pollution raises women's heart disease risk, says study

Stricter control of air pollution is needed to reduce the risk of heart disease in women, two Harvard researchers write in an editorial to be published in tomorrow’s New England Journal of Medicine.

Their comments accompany a study in the journal that shows long-term exposure to the fine particles in air pollution are more harmful to older women than previously known, raising their risk of heart disease and death.

Researchers from the University of Washington reviewed medical records from more than 65,000 postmenopausal women with no previous history of heart disease who participated in a long-running, federally funded study called the Women’s Health Initiative.

Other studies have shown a connection between fine particles in air pollution and death. But the pairing of the detailed medical records with data from air monitors in the 36 US cities where the women lived, revealed that women who breathed in more fine particles over a period averaging six years increased their chances of having heart attacks, strokes, blocked arteries and other illnesses. And the risk depended on the level of fine-particulate pollution in the area of the city where they lived.

"The findings of the WHI study strongly support the recommendations for tighter standards for long-term fine particulate air pollution," said Douglas W. Dockery of the Harvard School of Public Health and Peter H. Stone of Brighams and Women's Hospital and Harvard Medical School, writing in the editorial.

They noted that the US Environmental Protection Agency had recently lowered the standard for exposure to fine particles in the air over a 24-hour period but had declined to reduce the standard for longer-term exposure. Dockery and Stone called on the EPA to adopt a tighter standard, which has also been recommended by the agency's science advisers.

Posted by Elizabeth Cooney at 05:45 PM

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Listening is critical for patients' families, too

Listening more and talking less really does make a difference, not only for intensive care patients but also for their loved ones.

A UMass Memorial Medical Center physician lauds as "groundbreaking" a French study appearing in tomorrow’s New England Journal of Medicine that looks at how ICU doctors communicate with families.

Previous studies have shown that even desperately ill people do better when the goals of treatment, whether that means aggressive care or comfort measures only, are well explained and understood. But no one had looked at how communication affects relatives of patients dying in the ICU.

"The French study is groundbreaking because it shows if we spend a little bit more time, mostly listening to patients and their families, the well-being of survivors of patients who die is going to be better," Dr. Craig M. Lilly of UMass Memorial said in an interview. He comments in a New England Journal editorial, "The Healing Power of Listening in the ICU."

Dr. Alexandre Lautrette and a team of researchers in France tested levels of stress and depression in two groups of survivors. One group had standard end-of-life conferences, but the intervention group had longer sessions in which they did more of the talking. Follow-up telephone interviews showed lower levels of stress, anxiety and depression in the group that had longer conferences and more time to talk.

"All providers of critical care should receive training that will allow them to offer the kind of support that they would want if they had a family member who was facing death in an ICU," Lilly wrote in his editorial.

Posted by Elizabeth Cooney at 05:00 PM

« Exercise not a factor in risk of knee osteoarthritis | Main | Air pollution raises women's heart disease risk, says study »

Listening is critical for patients' families, too

Listening more and talking less really does make a difference, not only for intensive care patients but also for their loved ones.

A UMass Memorial Medical Center physician lauds as "groundbreaking" a French study appearing in tomorrow’s New England Journal of Medicine that looks at how ICU doctors communicate with families.

Previous studies have shown that even desperately ill people do better when the goals of treatment, whether that means aggressive care or comfort measures only, are well explained and understood. But no one had looked at how communication affects relatives of patients dying in the ICU.

"The French study is groundbreaking because it shows if we spend a little bit more time, mostly listening to patients and their families, the well-being of survivors of patients who die is going to be better," Dr. Craig M. Lilly of UMass Memorial said in an interview. He comments in a New England Journal editorial, "The Healing Power of Listening in the ICU."

Dr. Alexandre Lautrette and a team of researchers in France tested levels of stress and depression in two groups of survivors. One group had standard end-of-life conferences, but the intervention group had longer sessions in which they did more of the talking. Follow-up telephone interviews showed lower levels of stress, anxiety and depression in the group that had longer conferences and more time to talk.

"All providers of critical care should receive training that will allow them to offer the kind of support that they would want if they had a family member who was facing death in an ICU," Lilly wrote in his editorial.

Posted by Elizabeth Cooney at 05:00 PM

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Exercise not a factor in risk of knee osteoarthritis

Exercise makes no difference for the risk of osteoarthritis of the knee, Dr. David T. Felson and colleagues at Boston University School of Medicine report in the February issue of Arthritis Care and Research.

They studied 1,279 people from the Framingham Offspring cohort, beginning in the early 1990s. The results showed no relationship between recreational walking, jogging or other activity and developing knee osteoarthritis. Even in overweight patients who were at higher risk for osteoarthritis, exercise didn't raise or lower the risk.

Posted by Elizabeth Cooney at 08:47 AM

« Today's Globe: the new underinsured, pioneer in computerized medical records, brain bleeds at birth | Main | Researchers to hunt heart disease clues in WHI data »

Tuesday, January 30, 2007

What makes a good peer reviewer?

Some people are better than others at vetting research submitted for publication in medical journals, but it can be hard to tell who they are. A survey reported in PLoS Medicine says there are few ways to spot training or experience that make a difference.

Posted by Elizabeth Cooney at 10:38 AM

« Today's Globe: Hot rocks, climate change, screening tests, dialysis a world away | Main | New CMO for HealthOne »

Monday, January 29, 2007

'We wondered who was responsible for curing' ALS

Saying they can't wait for traditional research to bear fruit, two groups fighting amyotrophic lateral sclerosis will on Thursday toast their joint $36 million drug-discovery venture in Cambridge, a project led by people with personal ties to the disease.

The ALS Therapy Development Institute will have its $6 million annual budget matched by the Muscular Dystrophy Association for three years. The institute, founded in 1999, employs 35 people in Kendall Square but plans to hire 10 to 15 more, said institute president Sean A. Scott.

"Families banded together," said Scott, whose mother died of ALS. "Each of us had a relative with the disease. We wondered who was responsible for curing the disease. At the end of the day, nobody."

For the last five years the institute has screened FDA-approved drugs, looking for possible treatments for ALS. It will continue those tests while also searching for new compounds that might make it to Phase 1 clinical trials, CEO James Heywood said.

Better known as Lou Gehrig's disease, ALS is a chronic, progressive neurodegenerative disease that ends in paralysis. There are about 30,000 people with ALS in the United States.

Heywood's brother Stephen of Newton, who died in November, was the subject of a documentary film called "So Much So Fast."

Jamie Heywood was frustrated by the pace of ALS research.

"If we had decided to go to the moon the way we fund biomedical research, we'd have given $50,000 to 100 people and and wondered why we never got off the sidewalk," he said. "I think there's a need for programs that are rigorous and focused."

The institute describes itself as a "nonprofit biotech company" because of its industry-like approach to finding drugs that combat ALS or developing new ones. It appointed former Biogen Idec executive Steve Perrin as its chief scientific officer. Chairman Augie Nieto, for whom the Muscular Dystrophy Association's Augie's Quest is named, has ALS.

"There's a personal connection," Scott said. "The standards and aggressiveness are completely different when the next person taking the drug is a relative. It's not enough to have something published. It's got to work."

Posted by Elizabeth Cooney at 10:02 AM

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Sunday, January 28, 2007

No silent treatment for UMass' first Nobelist

The Nobel scientist with rock star looks got the big brass sound of the UMass-Amherst marching band he asked for at a bash in Worcester Friday night.

MelloWeb2005.jpg

Gov. Deval L. Patrick said "You throw a heckuva party" after he strode through the crowd and greeted UMass Medical School's Craig C. Mello, who shared the 2006 Nobel Prize in physiology or medicine with Stanford's Andrew Z. Fire. They discovered RNA interference, a way to silence genes that has revolutionized science and holds hope for saving lives.

As the governor took the hand of Mello's Hungarian-born wife, Edit, who was wearing a dusty-rose and black-lace confection, he told her she didn't have to curtsy.

Mello's family was treated like royalty by the 600 people invited by UMass Medical School to a community dinner celebrating the university's first Nobel. The UMass marching band crowded the more than football-field-size DCU Center ballroom and even got the 6-foot-3 Mello, with long black hair curling over the collar of his gray suit and French blue shirt and tie, to climb a chair and conduct them in a fight song. He obliged, fists pumping and arms waving.

Lt. Gov. Timothy P. Murray warned Mello: "He may be a brilliant scientist able to silence genes, but he's not able to silence politicians."

Patrick said he didn't understand all the science of RNAi, but he knew what lupus meant for his late mother and what diabetes and Alzheimer's mean to his wife, Diane's, mother.

"A silent gene causes no suffering," he said. "A silent gene means a cure. For that I thank you and honor you."

Guests included 1990 Nobel laureate Dr. Joseph Murray, the transplant pioneer who found a way to fight rejection, and cancer researcher Dr. Judah Folkman.

Mello urged politicians to restore shrinking government funding for research. The secrets of the genome sequence and RNAi have been unlocked, creating more opportunity and more need for funds to exploit them.

"I may not be able to silence politicians, but it's nice to have politicians who will listen," he said.


Posted by Elizabeth Cooney at 01:13 PM

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Friday, January 26, 2007

Statins over-prescribed, Harvard doctor says

Dr. John Abramson argued in his 2004 book "Overdosed America" that pharmaceutical companies are distorting medical knowledge. Now he writes in a medical journal that too many people -- healthy women of any age and men over 65 -- are taking statins without proof they need them.

A clinical instructor at Harvard Medical School and former chair of family practice at Lahey Clinic, he questions National Cholesterol Education Program guidelines recommending the blockbuster drugs for people who may have high cholesterol but don't have clogged arteries.

Commenting with Dr. Jim Wright of the University of British Columbia in the Jan. 20 Lancet, he says there's no proof that statins prevent heart attacks or strokes in healthy people, yet high cholesterol numbers are enough to prompt a prescription. We called him, and here's some of what he said:

Q. Where did the NCEP recommendations come from?

A: The full report is 284 pages. Near the back, talking about women, it says "the rationale for therapy is based on extrapolation of benefit from men of similar risk." We know you cannot extrapolate from men to women. ... And there are no gold-standard clinical trials that show benefit for older men without a history of heart disease.

Q. What about people who do have heart disease?

A. There is good evidence that statins are beneficial for secondary prevention but there's even better evidence that living a healthy lifestyle is even more effective than taking a statin, though they are not mutually exclusive. Don't think that by taking your statin you are doing everything you can do to reduce your risk of heart disease.

Everyone is focused on cholesterol, not on real epidemiological facts of what the risks are.

Q. Why?

A. The guidelines that create the clinical imperative for physicians are done by experts who have financial ties to drug companies that make the drugs being considered in the process. Fifty-nine percent of the experts who formulate the guidelines have financial ties.

In a meta-analysis of statins in the October Lancet, 13 out of 14 studies were commercially sponsored. The one that was not commercially sponsored showed distinctly less benefit from statins.

Q. What about you? The Lancet says you are an expert consultant to plaintiff's attorneys on litigation involving the drug industry, including Pfizer for its marketing of atorvastatin.

A. That's right.

Posted by Elizabeth Cooney at 10:06 PM

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Do Nobel laureates live longer? Harvard winner doubtful

Winning the Nobel Prize can add almost a year and a half to a laureate's life, two British economists say. But though he's 81,
Harvard physicist Roy J. Glauber, a 2005 Nobelist, isn't buying it.

"It strikes me as remarkably doubtful," he said.

The University of Warwick researchers, testing the idea that social status can influence quality of life and longevity, looked at nominees for the Nobel Prize in chemistry and physics from 1901 to 1950. They thought sudden success would tell them the effect of social status on the winners when compared to their nominated peers.

Winners lived to an average age of 77.2 years, 1.4 years longer than those who were simply nominated for the prize, who died at an average age of 75.8 years old. Varying amounts of prize money over the years didn't budge those averages, the researchers said.

But Glauber said the study might have been biased by the fact that many laureates aren't selected until they're quite old. Glauber won his Nobel 40 years after publishing his work on how light behaves.

"Needless to say, if you wait a long time in selecting any group of people, you've eliminated the people who have a short lifespan," he said in an interview. "That does load the dice in favor of longevity."

We won't know about Glauber's class of laureates for about another 50 years, when nominees' names are unsealed.

"You never know," he said. "Maybe a Nobel winner will live to be 150."

-- Elizabeth Cooney

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