Key Opinion Leaders (KOLs) are a very important part of the marketing mix that pharma companies use to promote their product. This article from the San Francisco Chronicle by Dr Lawrence Diller tells the story of one KOL.
Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States’ most influential doctor when it comes to determining whether their children are normal or mentally ill.
In 1996, for example, Biederman suggested that drugs like Ritalin might serve 10 percent of American kids for Attention Deficit Hyperactivity Disorder. By 2004, one in nine 11-year-old boys was taking the drug. Biederman and his team also are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.
The science of children’s psychiatric medications is so primitive and Biederman’s influence so great that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs. This happens in the absence of a drug trial of any kind – instead, the decision is based upon word of mouth among the 7,000 child psychiatrists in America.
That’s why Iowa Sen. Charles Grassley’s recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic. If true, this scandal is yet one more stake in the heart of American academic medicine’s credibility with frontline doctors like me – and more importantly, with the parents of the patients I deal with every day.
American medicine, with psychiatry the most culpable, has fallen back to a time more than 100 years ago when doctor credibility was tantamount to the promotion of patent medicine. Subsequent reforms severed ties between medical school doctors and the drug industry – and for decades there was a much more ethical balance between the industry and physicians.
Now once again, drug company money is corrupting medical practice and the maintenance of our country’s health. In a market economy, both doctors and the companies are motivated by profit. However, doctors’ Hippocratic oath and their personal/professional relationships with their patients attenuate the most crass aspects of a fee-for-service system.
In contrast, drug companies owe primary responsibility to their shareholders. Of course these companies must operate within legal business and Food and Drug Administration restraints, but the drive to push such rules to the limit is implicit in any business.
Such a strategy isn’t always beneficial when our children’s health is affected.
The Fortune 500 drug companies, by their sheer economic clout, have become the single most dominant influence in our health care system. The ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence.
In this climate, drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than nondrug (e.g., parenting and education) approaches.
That’s why we’re seeing famous (or infamous) Newsweek cover boys like Max, a 10-year-old who has taken 38 psychiatric medications in his short, unhappy life.
Research funding must be directed to the needs of patients and their doctors – not to the bottom line of stockholders. Drug companies can still make money, but it’s ethically immoral when stockholder profits trump children’s health needs (as in the cover-up of negative studies of antidepressants in children).
More money must be directed toward head-to-head competition between existing generics and the new products, and toward more studies comparing nondrug or combination approaches to drug-only interventions for children’s problems.
Drug company funding of medical research is not going to end – nor should it entirely stop. Yet a new set of federal rules dictating the transparency and direction of such funding is desperately needed to redress a dangerously corrupt system. It’s not enough to simply have doctors more explicitly report their incomes from drug companies, though it is a very useful first step.
I remember about six years ago when I read a major article by the Biederman team on the advantages of a non-Ritalin drug pathway for ADHD. On the same day, much to my dismay, I also heard him give a speech – for a Wall Street audience – promoting a new drug by Eli Lilly called Strattera.
Although Strattera turned out to be a bust both clinically and commercially for ADHD, I was still shaken that such a prominent researcher could be so brazen with his potential conflict of interest appearance.
The $1.6 million that Biederman didn’t declare is only a small fraction of the full amount of research funding that his clinic receives from nearly a dozen companies that pay for not only the cost of running studies but also the salaries of the doctors involved. Virtually all doctors who receive drug company money say they are not influenced, but every independent study examining the effects of such money says they are.
The leadership of Harvard’s psychiatry department is strangely silent or even defends Biederman. These are good men with solid reputations both in drug and nondrug aspects of treatment. Yet they know that their psychiatry department would not exist were it not for drug company money – considering the withdrawal of federal research dollars over the past 25 years and the meager reimbursements that psychiatrists receive for their services from insurance companies and Medi-Cal.
Sens. Grassley, a Republican, and Herbert Kohl, a Wisconsin Democrat, have introduced the Physician Payments Sunshine Act, which will require more vigorous reporting and enforcement on payments (anything more than $500) received by doctors from drug companies.
But in addition, we need laws to have the federal government, along with the major academic research centers, coordinate and direct the use of drug company money in medical research. This is not pie-in-the sky wishing. Such reform was precisely what the doctors of 100 years ago accomplished in this country.
Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is on the clinical faculty of UCSF. He is the author of “The Last Normal Child” (Praeger, 2006).