Your world shook today…but you probably missed it. If you’ve ever taken a prescription medication, and you relied on the pharmaceutical manufacturer to fully study the safety and effectiveness of the drug before seeking FDA approval, you should be really nervous right now. Today’s Journal of the American Medical Association (JAMA) had two articles and an editorial which state a compelling and shocking case of ghostwriting and guest authorship by Merck & Co. regarding Merck’s blockbuster drug Vioxx (rofecoxib).
I have to quote this or you won’t grasp the seriousness of what has just been disclosed in one of the country’s leading medical journals: “This case-study review of industry documents related to rofecoxib [Vioxx] demonstrates that Merck used a systematic strategy to facilitate the publication of guest authored and ghost written medical literature.” (emphasis added). Was this outrageous? Don’t take my analysis for granted. Look at the characterization of the editor-in-chief and the executive deputy editor of JAMA in an editorial: “[these articles] provide a glimpse of one company’s apparent misrepresentation of research data and its manipulation of clinical research articles and clinical reviews.” (emphasis added).
Why is this wrong? Let’s put it in very simple terms. In school, if you had a paper due and you turned in someone else’s work product and you didn’t disclose that it was the other person’s work, what was that called? Plagiarism…cheating…honor code violation. Pick your term, it’s all the same thing.
What Merck did was far worse because it was in support of a blockbuster drug that made the company billions of dollars.
This conduct will have even greater impact because the new “Bush” majority on the Supreme Court, led by Chief Justice Roberts, has been ruling on a rash of cases where the drug companies and medical product manufacturers are seeking legal protection from lawsuits if their product has FDA approval. This legal protection, called “preemption”, is at the core of recent Supreme Court rulings which have drug and medical product makers absolutely gleeful.
The Supreme Court is granting this bar to private lawsuits because the way the court sees it, drugs and medical products go through an FDA premarket approval process which the court calls “rigorous.” (page 4, Riegel v. Medtronic, Inc opinion, February 20, 2008). In this process, “a manufacturer must submit what is typically a multivolume application…[which] includes, among other things, full reports of all studies and investigations of the device’s safety and effectiveness… .”
Put that in the perspective of what JAMA published today and you’ll see that the Bush/Roberts Supreme Court is letting the foxes guard the hen house and there’s nothing you can do about it.
What’s even more remarkable about these articles is that they were published by the official journal of the American Medical Association (AMA). If you’ve read this blog before, you’ll know that the AMA is no friend of trial attorneys like me. In fact, they lobby pretty hard to limit lawsuits for people injured by medical care. But these articles were only possible because of documents uncovered in the Vioxx litigation! Play this out a bit further. Given what the Supreme Court is doing with preemption, there won’t be future lawsuits like the Vioxx litigation and the ability of doctors to figure out that a manufacturer is phonying up literature in support of a blockbuster drug will disappear.
Merck’s press release in response was almost sickeningly predictable. They called the articles in JAMA - that’s right in JAMA - false and misleading! Instead of attacking the physicians who wrote the articles, Merck tries to blame this on trial lawyers. All I’ll say is who do you trust here, the independent, well-respected medical journal, or the profit-mongering company that’s trying to defend its corporate reputation? Okay, I’m giving my bias away in the way I phrased the question.
Next time a Presidential candidate has a town meeting near you, why not ask them if they believe in protecting this kind of conduct by big pharma?