Why are pharmaceutical companies allowed to do their own trials?
A recent New York Times article clearly addressed the problem with big pharma being in charge of its own trials. In this case it was Pfizer doing a trial for Celebrex, but I previously wrote about Merck doing corrupt trials for Vioxx (see How Big Pharma Cooks Data: The Case of Vioxx and Heart Disease). In the article, it has the following damning evidence that this practice is ludicrous:
- Research Director Dr. Samuel Zwillich, in an email after a medical conference discussing Celebrex, stated: “They swallowed our story, hook, line and sinker.”
- Executives considered attacking the trial’s design before they even knew the results. “Worse case: we have to attack the trial design if we do not see the results we want,” a memo read. It went on: “If other endpoints do not deliver, we will also need to strategize on how we provide the data.” This simply can’t happen. There should be an outside third-party firm in charge of trial design, and there needs to be sign-off on the design in advance so no monkey business like this takes place.
- Executives disregarded the advice of an employee and an outside consultant who had argued the companies should disclose the fact that they were using incomplete data – they were using only half. This kind of statistical dishonesty is the easiest way to get numbers you want.
- In another email, associate medical director Dr. Emilio Arbe from Pharmacia (which was later bought by Pfizer) disparaged the way the study was being presented as “data massage,” for “no other reason than it happens to look better.” Mind you, this statement was made in September 2000, so in other words the side effects of Celebrex have been known for over a decade.
- Medical Director Dr. Mona Wahba described it as “cherry-picking” the data. In May 2001.
Why is this happening? It’s all about money:
It is one of the company’s best-selling drugs, racking up more than $2.5 billion in sales, and was prescribed to 2.4 million patients in the United States last year alone.
How much are you in doubt that the people in charge are being pressured not to be honest? Dr. Samuel Zwillich claims the hook, line and sinker statement was probably about something else. The cherry-picking Dr. Mona Wahba now can’t remember what she meant.
This is bullshit, people. Statistics is getting a bad name, and people are suffering and dying from bad medicine, not to mention paying way too much for fancy meds that don’t actually help them more than aspirin.
What we need here is some basic integrity. And it’s not just a few bad eggs either – stay tuned for a post on Prof. David Madigan’s recent research on the robustness of medical trials and research in general.