At least 38,000 Americans are believed to have died from taking the pain pill Vioxx before it was withdrawn last year. Drug maker Merck is now facing thousands of lawsuits.It comes as little surprise that the pharmaceutical industry would try to play up the positives, and play down the negatives of their products - every industry does the same. But, when the negatives pose serious health risks - up to and including death - then it becomes a trickier issue. Do these companies have the obligation to do more - or at a minimum, don't they have an obligation not to suppress what is known? Merck appears to have conducted a coordinated effort to suppress the criticisms of doctors who were questioning Vioxx - including doctors they had initially signed up to act as spokespeople.
Over the past few months, it has emerged that the company was aware for years that Vioxx might be dangerous. Now, new documents obtained by NPR suggest that even as Merck was making Vioxx into a bestseller, the company was putting pressure on independent doctors. The company's apparent aim: to keep them from discussing evidence of Vioxx's potential safety problems. The documents show that Merck exerted pressure not only on individual doctors, but also on several of the nation's top medical schools.
Early in the marketing process, Merck had recruited Gurkirpal Singh of Stanford University, "Merck wanted Singh on board because he was a senior researcher on a seminal study of arthritis patients." Singh had been an advocate for Vioxx until certain research began coming out which linked Vioxx to increased rates of heart attack. Merck refused to provide the documentation of those studies to Singh, and he began to criticize the drug. Of course, Merck didn't just take that laying down...
Dealing with Singh was now a job for Merck's senior vice president for medical and scientific affairs...Merck documents obtained by NPR show that a detailed account of Singh's activities was now prepared...Almost a dozen Merck executives were involved...The profile of Dr. Singh is remarkably complete," says Columbia's David Rothman, who reviewed the final document for NPR. "One can't help but almost frame it in terms of an FBI dossier, except here Dr. Singh is not cavorting with possible communists, or possible gangsters. Here the dossier is filled with Dr. Singh's take on Vioxx, who is Dr. Singh talking to. It's scrupulously watched and very, very carefully recorded."...Around the same time, Singh heard from a friend inside Merck: "I was told [a] vice president at Merck, had become 'very interested,' in quotes, in what I was doing, and that [the vice president] is "very powerful, and he's going to crush you and he's going to fix you.'"It also appears that the drug company went after Stanford, where Singh was a researcher.
Lisa Bero is a professor of clinical pharmacy and health policy at the University of California, San Francisco. She's done extensive research showing how funding from drug companies influences academic science. She reviewed [an] email [regarding influence at Stanford] at NPR's request.
"I didn't realize how powerful the drug companies thought they were," Bero said. "For example, having enough influence over a department to say 'change what your faculty member is saying.' I haven't ever seen that documented before."
Obviously, big drugs are big money - and they are not just big money to the drug companies - but to the medical schools who reap financial windfalls from that industry.
In 2004, Stanford's medical school got 9 percent of its research budget -- $29 million -- from drug companies. NPR surveyed several medical schools and found that's not unusual.This was a really good report, and I highly recommend you take a read or a listen over at NPR. This type of report really questions how much these drug companies know about the detrimental side affects of their drugs, when they know it, and what they do with that information. Obviously, in the day and age in which we live, there are going to be side affects to much of this new technology, much of which is tolerable due to the overwhelming benefits of the drugs created. But, it is imperative that these trade-offs - this balancing of costs and benefits - be a public and transparent process. It appears that the entire pharmaceutical industry may be less than transparent in that process. Today's NY Times has a story entitled Lucrative Drug, Danger Signals and the F.D.A., which is an examination about similar issues at Johnson & Johnson related to a heartburn medicine.
The really distressing thing to me is that all of this is occurring amidst a background of record profits for drug companies. Is there a correlation between the thirst for profits and market expectations, and the pressure to suppress bad news about 'miracle drugs'?