A massive study of hypertension medication that enrolled more than 42,000 patients concluded earlier this decade with good news: The cheapest of the 4 drug types tested, diuretics, were the best option for most people. At the time the number 1 brand name drug to treat hypertension, the calcium channel blocker Norvarsc, cost $1.50 to $2 for a one-a-day pill. Generic brands of diuretics cost about 10 cents a day.
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, or ALLHAT study, epitomizes all that is good about clinical trial research gather the leading drugs for a various ailment, test them, and determine the best option for public health.
Such trials are, alas, an anomaly in the current landscape of clinical trial research.
That`s because drug companies hold undue influence in the conduct of research trials, which may lead to misrepresentation of research data, and manipulation of clinical studies as well as review articles. Such influence often remains cloaked, but not always. Most recently, during litigation involving Merck`s drug Vioxx, a pair of examples were brought into clear view. Reported in April by the Journal of the American Medical Association, one of 2 articles outlines the extensive practice of ghostwriting employed by Merck, and the second shows how the company appears to have misrepresented Vioxx`s mortality risk to the US Food and Drug Administration.
The profession of medicine, in every aspect clinical, education and research has been inundated with profound influence from the pharmaceutical and medical device industries, the journal`s editor in chief, Catherine DeAngelis, MD, thundered in a JAMA editorial. This has occurred because physicians have allowed it to happen, and it is time to stop.
A growing body of scholarship has cataloged the magnitude of drug company influence on clinical trials. This has not only proven embarrassing for the medical profession, and here emergency physicians often find themselves on the front lines of patient interaction, but it also may have begun to undermine public confidence in the practice of medicine. The latest bombshell landed in the New York Times recently with revelations that a prominent Harvard child psychiatrist received $1.6 million from drug makers between 2000 to 2007, much of it unreported, according to a Congressional investigation. Joseph Biederman`s research, often industry funded, has been instrumental in broader use of antipsychotics in children.
Now, with the Merck examples coming to light, some physicians are re-examining what they, professional societies, medical schools and the government can do to ensure that there are fewer conflicted clinical trials, which serve the aims of profit rather than evidence-based medicine, and more ALLHAT-like studies. |