The FDA Approval Program: A Fast Track to Disaster

[Guest guest]

The FDA's "accelerated approval" program has about as many holes as a saltshaker. And that is fitting since you'll want to take their most recent defense of the program with a grain of salt.

 

While you won't see it leading the evening news, a new government report revealed that the FDA has helped Big Pharma rack up huge profits by fast-tracking certain drugs -- without any proven clinical benefit.

You see, in a supposed effort to "rush the cures" to the people that need them when they need them most, the program allows the FDA to approve a drug before even standard safety testing and lets the drug companies provide follow-

up data years after the drug has been released.

 

But now we know what happens once the FDA gets the actual data. Nothing!

 

The new report from the Government Accountability Office chastised the FDA's accelerated approval program for allowing expensive cancer and HIV drugs to stay on the market even when follow-up studies showed they didn't extend patients' lives.

 

Imagine if a natural product claimed to cure cancer or HIV, cost hundreds or thousands of dollars, and did nothing. What do you think the FDA would do then?

They certainly wouldn't just sit back and watch the profits roll in.

And if this rushed approval program wasn't enough of a sweetheart deal for pharmaceutical companies, check this out: the companies aren't even ponying up the required data. Since 1992, the FDA has requested 144 follow up studies and at least one-third of those studies have not been completed. To make matters more troublesome, even when follow-up data is provided, the FDA has never once recalled a drug that had been given accelerated approval - according to the GAO report, they don't even have a policy for doing so!

 

In one particularly frightening example, the agency approved the lung cancer drug Iressa on the condition that it reduced the size of tumors. Subsequent studies showed that Iressa not only didn't extend patients lives but actually caused hundreds of cases of an often-fatal pneumonia. Despite these findings the drug is still on the market!

Shire Laboratories, maker of the fast-tracked blood pressure medication ProAmatine, has neglected to provide studies for over 10 years. All the while Shire has racked up almost $300 million in sales for a drug that has never been proven to have any clinical benefit whatsoever!

And here's the kicker: according to FDA Deputy Commissioner Dr. Joshua Sharfstein they don't plan on making any changes to their "accelerated approval" program. He defended the agency's stance by saying that "we don't want to lock ourselves into a specific set of criteria that takes away the flexibility to do what's right for the public health."

Huh - that's odd. It seems like that's exactly what the FDA is doing by allowing these untested drugs to stay on the market. And since it doesn't look like the FDA will be volunteering this information to the general public any time soon, I urge you to check out the list of the drugs that have been rushed through the approval process. If you are taking any of these medications, it would be worth asking your doctor about a possible replacement – one that has actually been proven to work.

 

Click here for the complete list.

Be Well,

Jim Campbell

Sources:

 

"FDA fails to follow up on unproven drugs, GOA says" Matthew Perrone, Lubbock Avalanche-Journal, 10/26/2009, http://www.lubbockonline.com

 

http://www.fda.gov