Over the past decade, some two dozen cancer drugs have been given "fast track status" by the FDA in hopes of speeding experimental drugs to patients, particularly those facing terminal illnesses, even if these drugs don't help them live longer. This accelerated approval process is now being questioned more vigorously by a growing group of health professionals. Their concerns:
Many of these drugs were first tested on small groups of patients--no more than 300.
Fast track approvals may not provide an accurate gauge of a drug's effectiveness or toxicity.
An analysis of clinical trials of 26 fast-track drugs by a Northwestern University professor found, with many cases, only a few dozen patients were actually helped by them. Even worse, 25 percent of these accelerated cancer drugs on the market for less than 18 months have produced serious side effects.
Although the FDA mandates follow-up studies of those fast-track drugs, two-thirds of those tracked in the study haven't fulfilled this requirement. Moreover, the federal agency has yet to rescind an approval even when any of those few follow-ups were disappointing.
One FDA official argues finding entirely safe cancer drugs using this fast-track method is far more of "a balancing act," and probably isn't achievable. Additionally, they must be given in high doses to be effective at all. Even though these accelerated drug approvals may have helped some patients, experts say, they shouldn't be considered "blank checks" that absolve drug makers of their responsibilities.
USA Today March 10, 2005
The Northwestern University researcher and physician I refer to in this article is one of a growing number of hard-working critics punished by the FDA for his honesty. After a scathing review of their drug practices last year in which he gave the FDA a failing grade for drug safety, the agency revoked the special access the doctor and his watchdog group had to its adverse drug reaction database.
I'm amazed how the FDA can get away with being so openly vindictive and punitive, adding even more gasoline to a recent firestorm of criticism that underscores just how fatally flawed their way of handling what passes for drug safety in this country really is.
Think about it, folks: The only "legal" way Vioxx had any chance of being reintroduced to the market after killing some 55,000 people was if a 32-member panel charged with reviewing its efficacy approved it. And thanks to 10 members who hadn't publicly disclosed their financial ties to some of the world's largest drug makers, Vioxx was approved by a narrow 17-15 margin.
If this doesn't wake you up to just how evil the drug companies are, then I simply don't know what will. The Vioxx debacle alone was one of the biggest stories since I started this newsletter in 1997, yet the media has not given it the attention it truly deserves. And, before you know it, the story will be buried and long forgotten by most Americans. In fact, many seem far more interested in the Michael Jackson trial than anything having to do with their health!
Fortunately for this nation and us, some amazing individuals still work at the FDA. Dr. David Graham still serves as the associate director of the Office of Drug Safety for the FDA. He is a graduate of the John Hopkins University School of Medicine and trained in internal medicine at Yale and in adult neurology at the University of Pennsylvania.
If you want a glimpse into the mind and heart of a public servant who's truly dedicated to doing the right thing, I urge you to read Dr. Graham's testimony to Congress late last year in which he blew the whistle on Vioxx.
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Can You Really Trust the FDA to Protect You From Harm?
Finally -- FDA Admits That ALL Anti-Inflammatories May Kill You
FDA is "Virtually Incapable of Protecting You From Unsafe Drugs"
$30 Billion Vioxx Recall -- The Dangers, Powerful Lessons & Safe Alternatives that Everyone Must Know
Moneyed Interests