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."

Posted by Gideon Gil at 01:43 PM

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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

Harvard 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

Beth 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?

Kitai 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 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 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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