PHARMA: Vioxx not an anomally, by John Abramson MD

Will Celebrex and the other Cox-2s follow the Vioxx path? Indications from Canada based on 14 reported deaths suggest that they might. Meanwhile Pfizer is initiating an ambitious and potentially risky clinical trial to try to prove that Celebrex is good for your heart (or at least not as bad for it as Vioxx!) Given that the risks of Vioxx were known for several years by Merck and some others, is the FDA paying enough attention to the safety of the nation’s drugs? I don’t know and I’m sympathetic to the argument Sydney made in Medpundit a while back about the good of the many taking Vioxx versus the incremental risk for the few. However, John Abramson, the author of Overdosed America: The Broken Promise of American Medicine is pretty sure. He writes this for THCB:

Research on Vioxx done for my book, Overdosed America, was included in Monday’s Wall Street Journal article. The lack of public discussion about the two most important lessons to be learned from the Vioxx recall guarantees that this debacle will be repeated again, and again, and again.

The VIGOR study that Merck completed in March 2000, comparing the safety and efficacy of Vioxx to naproxen (Aleve), showed clearly that even among those without a previous history of cardiovascular problems, Vioxx doubled the risk of heart attacks, strokes, and blood clots. Vioxx actually increased the number of serious cardiovascular problems more than it decreased the number of serious gastrointestinal problems. The FDA’s cardiology reviewer wrote in February of 2001 that the increased risk of cardiovascular complications with Vioxx "could lead one to conclude that naproxen…would be the preferred drug."

And the most important finding of the study: The people who took Vioxx developed 21% more serious complications (the kind that cause hospitalization or death).

The problem is that neither of these two findings was included in the November 2000 issue of the New England Journal of Medicine. So doctors were left believing that, even though Vioxx is no more effective at relieving arthritis symptoms and cost many times more than naproxen, Vioxx was the better drug for their patients.

The more general issue (and the primary theme of my book) is that most of even the best information available to doctors and patients is produced and disseminated by commercial interests with the goal of improving their bottom lines, not the health of the American people. Seventy to 80 percent of our clinical studies are now funded by the drug and medical device companies. Among the highest quality research, the odds are still 5 times greater that commercially sponsored studies will favor the sponsor’s drug than will non-commercially funded studies.

If the health care market is to serve the interests of society, the quality of the information that provides the basis for health care decisions must be impartially overseen. The situation that we now have with drug companies funding and controlling most of our clinical research is like a professional football team generously providing the referees for its games.

Many people say that the last thing we need is another federal regulatory body. But not even libertarians suggest that the government should back out of its role in the enforcement of business contracts. In our "information age," accurate medical knowledge is as fundamental to the quality (and cost) of our health care as is the enforcement of contracts to the function of markets.

The fundamental "lesion" in American health care is the normalcy of commercial bias in our medical knowledge–which now grows toward corporate profits the way that plants grow toward sunlight. Until this problem is addressed unsafe and unnecessarily expensive drug like Vioxx will continue to achieve "blockbuster" status, and Americans will continue to pay more than twice as much for health care yet have the worst health of 22 industrialized nations.

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4 replies »

  1. I read Dr.A’s books long ago and can tell you only one thing… Look carefully through the quagmire! But it IS good to know that I’m not the only one who is…
    Later, Terry

  2. “Overdosed America”by Dr. John Abramson,MD is one of the most important books you can read and everyone should read it. My Dr. recommended it to me a year ago.
    Look at the date of the first article 2004, and now in 2008 the drug companies are being busted for their statins drugs..money, money, money at OUR expense.What is wrong with Congress? They need to protect us and all Americans better wake up and get educated on this most important issue.
    Prescription drug free in massachusetts!

  3. The pharmaceutical industry makes billions of dollars drugging school children and this is a form of genocide: condemning millions of young lives to a drug addicted future. They employ “experts” and lobbyist and hire ex FDA personnel and retired congressman to get pro-drug legislation passed. Newspapers and magazines receive billions of dollars a year in advertising, and investment firms make big bucks touting the latest snake oil; so it would be a rare article indeed that went against Big Pharma. The industry is motivated by the bottom line and shareholders not Science. A Google search of Ritalin and Cocaine, Prozac, chemical imbalance, school shootings, will show even the most skeptical that something is horribly wrong when 6 million school children ( plans are in place to increase this by 40% each year) are on anti-depressant drugs prescribed to handle “disorders” created to sell the drugs. Now after the Texas Vioxx decision Big Pharma’s stooges are flooding their editorial outlets ( USA Today, the New York Times, Wall Street Journal) with demands that the government protect the drug companies. Michael
    PS The decision by the Texas jury was rendered because the defendant couldn’t explain their faulty “science” to the common man. Something that contains lies is very hard to explain as it gets very complicated whereas that which is true is simple and easy to explain.

  4. I see a problem in both sides. Vioxx may increase the risk of problems, but look at all the side effects that other drugs cause. Is it just a problem because it didn’t list the side effects possible? My migraine med says that there can be heart related problems even if you have no heart problems now. If Vioxx lists heart realted problems as a side effect, would it be ok then? Just like my birth control pills increase the risk of blod clots,and it is stated in the side effects area. So I am given this information and it is my choice weather I take it or not. Shouldn’t people taking Vioxx be given this same choice?
    Or should the FDA protect people from every side effect. Just don’t know.
    Its a hard one to answer.
    Just Me…