Cambridge firm readies push on alcoholism drug
In the high-stakes world of biotechnology, a Cambridge company's experimental injection to treat alcoholics should have all the makings of a big winner.
But first the company,
The drug, called Vivitrex, has a distinct advantage over alcoholism pills now on the market: A single shot delivered by a needle slowly releases itself into the bloodstream over a month, meaning alcoholics can't decide to skip a dose during that time.
After tests showed Vivitrex coupled with counseling helps reduce heavy drinking, the Food and Drug Administration sped up its approval process. A decision is expected Sept. 30 and it could be available early next year. Stock analysts predict Alkermes could sell $300 million of Vivitrex annually, making the company profitable for the first time in its 18-year history.
To get there will require a sea change in treatment. Three drugs have already been approved to fight alcohol abuse, but only a fraction of alcoholics ever receive a prescription.
''If you look at primary-care physicians, they're probably not even aware there are medications out there to treat alcoholism, to be honest," said Dr. Raye Litten, leader of the medications team at the National Institute on Alcohol Abuse and Alcoholism in Bethesda, Md., part of the National Institutes of Health.
Alkermes has launched a campaign to change the way doctors fight the disease. It has sponsored talks at national doctors' meetings and underwritten education programs that discuss using drugs to treat alcoholism. It recruited the country's top alcohol-abuse doctors to run clinical tests of Vivitrex, and then hired one of those doctors as the company's vice president of medical affairs.
At a time when large drug makers are increasingly under fire for manipulating consumers with advertising, Alkermes's strategy offers a window into how even a small company that does not use direct-to-consumer advertising can get under the hood of the medical profession, shaping not what patients want, but how doctors think about what they do.
''I want to make sure that doctors all think of alcoholism as a chronic medical condition," said Alkermes marketing director Mona Haynes, who was hired to run the Vivitrex marketing effort in 2001, when the drug was still in early phases of clinical testing.
Although alcoholism has long been defined as a disease, it is still treated more like a behavioral problem. If alcoholics see a doctor, they are usually referred to counseling.
''The standard model is going through Alcoholics Anonymous or going to some kind of group therapy session," said John Bauhs, a 41-year old personal chef in Maryland who is a recovering alcoholic.
Alcoholics Anonymous neither supports nor opposes the use of drugs in treatment, said a spokesman for the organization.
Bauhs credits his sobriety to naltrexone, a drug he found out about while surfing the Internet a year and a half ago. He said he spent a decade bouncing in and out of treatment programs without being told medications existed.
When Alkermes executives talk about changing that mindset, they evoke the broad shift that hit psychiatry in the early 1990s. A massive marketing effort by Eli Lilly & Company, maker of Prozac, helped shift the medical consensus on depression; in just a few years, it went from a condition treated chiefly with psychotherapy to a disease for which a psychiatrist would most likely prescribe drugs.
''We're entering a period of time that when people look back on it 20 years from now, that was the time that medicalization of alcoholism began," said Alkermes chief executive Richard Pops.
In a sense, alcoholism was ''medicalized" back in the 1950s, when the first pill was approved for alcoholics. Disulfiram, sold today by Odyssey Pharmaceuticals under the brand name Antabuse, makes people violently ill when they drink.
Two other drugs have become available in the past decade: Naltrexone, which appears to block the intense rush of pleasure that many alcoholics feel when they drink, and acamprosate, which helps ease withdrawal symptoms.
All three drugs come in pill form, however, and part of doctors' reluctance to prescribe stems from the fact that patients can simply stop taking a pill and resume drinking. For example, acamprosate, sold by
To remedy the problem, Alkermes took naltrexone and suspended it in tiny spheres of a polymer that emit the drug slowly. One injection in the buttocks keeps the drug flowing through the patient's system for 30 days. A test of several hundred alcoholics showed that the drug helped them reduce their heavy drinking.
Alcohol researchers see promise in the new approach, as do drug industry analysts. But to reach enough of America's 8 to 16 million alcoholics to make a difference -- and to make money -- Alkermes needs to overhaul the way alcoholism itself is treated.
''The alcohol treatment system in the US was designed in the 1970s, when all you had was group counseling and Alcoholics Anonymous," said Dr. Mark Willenbring, director of treatment research at the National Institute on Alcohol Abuse and Alcoholism. ''So the system wasn't built up in a way that medications are part of the picture."
Alkermes is hiring a team of people to build a network in 30 American cities, hoping that will make it easier to get patients on Vivitrex, said Dr. David Gastfriend, an addiction researcher who left Harvard Medical School last March to become the company's chief of medical affairs. These ''treatment systems specialists," who will be employees of Alkermes, will fan out and try to construct mini-networks that include a psychiatrist, a counselor, and a nurse or doctor comfortable with giving injections. Alkermes employees will coach the doctors in how to share patient information without violating privacy rules. The company hopes to generate a nationwide list of Vivitrex providers and make them available to the public through a toll-free telephone number.
The company isn't offering money to the doctors, but Gastfriend said he knows physicians who are eager to expand their treatment of alcoholism beyond ''talk therapy."
''There's a pent-up demand," he said. ''They've been hearing [alcoholism] is a brain disease; this is the decade of the brain, so what are they supposed to do, talk more about that?"
Alkermes's efforts are also getting a boost from researchers. government's top alcoholism-research institute recently changed its guidelines for how doctors should treat alcoholics, offering a one-step screening test and listing available medications.
Alkermes underwrote an American Medical Association news conference in July at which Willenbring, Litten, and other federal scientists spoke optimistically about the prospect of doctors someday medicating alcoholics more regularly.
Alkermes has also provided grants for the country's major addiction-medicine groups, the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, and the Research Society on Alcoholism. It bought full-page ads in medical journals published by addiction-medicine associations, promoting the idea that medicine cures alcoholism or tying the Alkermes name to addiction management.
Until its drug gets federal approval, Alkermes is forbidden by the FDA from promoting Vivitrex by name, but it has managed to work the brand into the medical conversation. A news release announcing positive test results in 2001 trumpeted a statement from alcoholism researcher Dr. Bankole Johnson of the University of Virginia that ''Vivitrex has the potential to become an important therapeutic agent in the treatment of alcoholism."
In an Alkermes-funded study published in April in the Journal of the American Medical Association, which directs authors to avoid using brand names in articles, the company's clinical testing network was called the ''Vivitrex Study Group," earning the name a mention on the article's first page.
Although some of the tactics raise the question about whether a drug company is pushing the limits of allowable marketing, Alkermes's campaign has been enthusiastically greeted by doctors. The drug isn't perfect -- it seemed to work less well in women, and could carry a warning because of potential liver damage -- but many say the company could, and should, help get more alcoholics on prescription medicine.
Helen Pettinati, an addiction specialist at the University of Pennsylvania who was a clinical investigator for the most recent Vivitrex study -- and who has spoken frequently at Alkermes-sponsored medical sessions -- said she hopes Alkermes succeeds where naltrexone in pill form failed.
''When it first was approved by the FDA in 1994, it didn't seem like the drug company, which was Dupont, marketed it at all," she said. ''I hate to say that marketing helps, but you have to get people to know about the drug."
Stephen Heuser can be reached at sheuser@globe.com. 
