Earlier this month, the Journal of the American Medical Association exposed pharma giant Merck for obscuring the source and results of studies published about their drug Vioxx. It turns out that dozens of articles favorable of Vioxx were written primarily by Merck employees.
The company conducted and interpreted the research, hired ghostwriters to write it up, and then paid academic medical experts to put their names on the papers before they were published, said the journal. JAMA’s investigation shows that in at least one case, a study’s draft text was even affixed with “External author?” where the byline eventually listed medical experts. Merck also failed to report connections between Vioxx and death in patients with Alzheimer’s, according to the journal.
At this point, such news is not as surprising as it should be. Since Vioxx was pulled from the market in September of 2004, facts have emerged time and time again exposing questionable and unethical behavior on Merck’s part.
A few highlights:
- Vioxx was supposed to be easier on the stomach than the older drug Naproxen. But in 2000, just months after Vioxx’s approval, a Merck study showed it also caused twice the heart attacks, strokes and deaths that Naproxen had. Rather than relay that information to doctors, Merck instructed several thousand Vioxx sales people to sidestep the issue.
- That information reached the House Committee on Government Reform in 2005. According to the Washington Post, Merck’s CEO of 11 years stepped down, without warning, the very day the committee released “a slew” of documents showing that Merck had aggressively marketed the drug they knew could be dangerous.
- As the connection between Vioxx and heart problems became stronger, high-ranking medical experts began to voice concern. An investigation by National Public Radio showed that Merck put pressure on individual doctors as well as top medical institutions who raised questions about the drug’s safety. Implicit in the attempt at censorship, said NPR, was the threat to withdraw millions of dollars in funding, on which many institutions’ research relies.
Merck knew Vioxx could be dangerous years before they took it off the market.
They instructed their own staff not to discuss the drug’s serious risks. And they tried to censor independent analysts who attempted to do so. Of course, Vioxx was eventually recalled (another studied showed it caused five times the heart attacks and strokes than a placebo), but not before more than 80 million people took the drug. And an estimated 38,000 of those patients died because of it.
So why should these new reports from the Journal of the American Medical Association come as a surprise? Well, to many, these reports are a very serious concern, even though this happened several years ago, and this why: JAMA says that Merck is not alone in this behavior; other large drug companies do the same thing.
Now, a medical expert’s stamp of approval should be reassuring, both to patients and to doctors who decide whether or not to prescribe it. But what if the actual ‘approval’ comes from the corporation who profits from people believing the drug is safe?
Vioxx was a big money maker for Merck, netting $2.5 billion in annual sales. Of course they want it to appear safe. And medical researchers want the prestige, opportunity and money that comes with publishing important studies.
In theory, the health and safety of patients should always come first. But with profit so tightly woven into each step of the process, it’s hard to really know whether it’s money or science that is given the benefit of the doubt.
Big pharma provides major funding to the nation’s top medical schools and research institutions. Those schools mold the doctors who serve our county’s patients and end up working for the FDA. The FDA is often criticized for hastily approving drugs that turn out to be dangerous, and the studies on which they base their decisions are often done by the drug companies. Practicing doctors don’t trust sales representatives, so they turn to experts and medical journals. Drug companies pay doctors to promote their products at conferences, and some of these same doctors serve simultaneously on FDA panels. And, as Merck has shown, these companies even pay experts to put their names on published studies.
Merck claims the experts whose names are on the articles played an active role in the research, but after so much deception, such excuses don’t count for much. With 38,000 deaths (and thousands more heart attacks and strokes) connected to just one drug, it is clear that something needs to change.
But who should initiate the much-needed reform: The FDA? Drug companies? Doctors? Researchers? While all these play different roles, the victim is always the same: the patient, and the patient’s family.
One thing the public can do is hold these parties responsible for the consequences of their actions. Merck’s choices were clearly driven by profit, but when Vioxx finally went down in flames, they saw a major drop in profits as well as in stock value. And over 44,000 people have joined in a class action suit, in which Merck has agreed to pay $4.85 billion for the damage Vioxx has caused.
But this is just one drug out of hundreds. The ten largest pharmaceutical companies earned nearly $40 billion in 2006 alone; it seems putting patients’ lives in danger is something a large company may be willing to do, as long as it is cost-effective minus a lawsuit here or there. These companies claim to have patients’ health in mind, but Merck’s behavior, if it is to be taken as any sort of example, is hardly encouraging.