How to get FDA approval for anything!

Buying the FDA - By Terry A. RondbergWhile pharmaceutical companies have boasted for decades that their pills and potions are “approved by the FDA,” does that really mean anything? Apparently, very little, if the story of how one drug — Multaq (dronedarone) — “earned” its approval is any indication.

Drug maker Sanofi-Aventis touts Multaq on its website as “a prescription medicine used to lower the chance you would need to go into the hospital for heart problems.” The FDA’s decision to approve the drug was based primarily on a study conducted last year by Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health. The paper was published in The New England Journal of Medicine.

However, it turns out that Page was pretty much “bought and paid for” by Sanofi-Aventis. The drug company PAID for the research, collected data, and performed the analysis without an external audit. Page put his name on the paper, never having seen the raw data. He simply trusted the company to be honest and ignored the fact that the major financial experts, including Morgan Stanley, estimated the drug could reach nearly $3 billion in revenues.

In addition, Page and four co-authors were Sanofi-Aventis paid consultants and/or speakers, and two co-authors worked directly for Sanofi-Aventis, and owned stock in the company.

Despite all that, Page shrugged it off with a glib, “There is a sense of trust that they won’t falsify data.” Either he’s incredibly naïve, or he thinks the rest of us are.

To add injury to insult, the Multaq branded pill was selling for 47 times as much as its generic equivalent — in Britain Sanofi was selling the drug for £2.25 pounds per day, compared to 5 pence a day for a generic competitor, amiodarone. That equates to $3.30 compared to 7¢!

But wait … it gets better. Another research study (this one, by researchers at the Cedars-Sinai Heart Institute — Journal of the American College of Cardiology, 2010; 55: 1569-76) has concluded that the branded drug is far less effective than the current standard drug, Cordarone (amiodarone) for atrial fibrillation, and has no safety benefits.

That’s pretty much what was known back in 2003, when a drug trial was actually stopped because patients receiving Multaq were dying in greater numbers than those getting a placebo.

Still, the drug was “approved” by the FDA. You have to ask yourself — what would it take for a drug to be rejected?

3 thoughts on “How to get FDA approval for anything!”

  1. I am very sad when I read these types of articles, because it is becoming more the norm than the unusal. What will it take for the governments to take back control and provide safe therapys for our most vulnerable members of the public.

  2. Each diagnosis of cancer is (on average) worth somewhere between $300,000 and $500,000 to the medical industry. More than half of this money goes to the drug companies. Due to lobbying and other incentives, it’s no secret that both the FDA and the AMA are heavily influenced by drug companies

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