Several years ago, researchers at the University of Medicine and Dentistry of New Jersey predicted that the FDA’s drug approval system would only result in “drug disasters.”
They analyzed data on drug reactions and the current approval process and found that, shockingly “new drugs are twice as likely to harm patients as provide them with benefits.” This is due to a broken approval process in which drugs are assumed to be safe and effective based on incomplete data.
Another study, this one from earlier this year, reached a similar conclusion. Researchers revealed that only about 51 percent of the new drugs approved in the last decade had comparative effectiveness data available–meaning the FDA has been approving drugs without really knowing if they’re any better than what’s already out there.
I think it’s safe to say these studies are on to something big. And this business with Avastin is only the latest illustration of just how broken this “shoot first look for evidence later” system is.
This month, the FDA withdrew the breast cancer indication for Avastin–a drug that had been rushed through an accelerated approval program in 2008 (around the same time the New Jersey study highlighted the risk of those “drug disasters”). It turns out that the drug, which costs $80,000 a year, was not nearly as safe and effective as the rush-job approval indicated.
The fact is Avastin was approved for breast cancer without much evidence (one trial) that the drug was safe or effective–instead, the FDA required confirmatory trials to test the drugs’ benefits AFTER it was approved.
Five trials later, the truth has emerged: The drug’s effects appear weak, and its risks are potentially life-threatening. Those risks include hemorrhaging, heart failure, and development of dangerous perforations in parts of the body including the stomach and intestines.
Of course, it’s not like Avastin is gone. The blow might represent a loss of up to one billion dollars a year in revenue for its makers, but it’s still going to be used for various other cancers, and a representative of Roche pledged the company would help patients who “may be facing obstacles to receiving their treatment in the United States.”
This might be a victory–especially considering Avastin is the world’s best-selling cancer drug–but it’s only a small one. The truth is that for every drug like Avastin that’s rushed through the approval process only to be restricted later, there are many more that remain on the market despite very little evidence that they do any good at all–or that there aren’t serious long-term risks.
We can’t keep allowing the FDA to subject us to drugs that aren’t proven safe and effective. Rushing drugs through their approval process is a dangerous game that keeps us from learning how these drugs really work–and how they don’t work.
Until the system is changed, we can only look forward to more stories like this one–small victories that don’t do much for the big picture.
Ms. O’Brien has written for Nutrition & Healing, Healthier Talk and a variety of other natural and alternative health outlets. She believes in the power of natural medicine and her goal is to open people’s eyes to the benefits of alternative and integrative medicine.
Christine is passionate about helping people help themselves without having to turn to harsh drugs or invasive surgeries.
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