The FDA's fast-track program for cancer drugs is pure scam--start to finish

Empty promise

If you have cancer, your doctor might give you encouraging news that the FDA just approved a new experimental cancer drug. In fact, he might tell you that the drug is so promising that it was given special fast-track approval so it can be rushed to patients.

But beware of that one word: experimental.

Because your doctor probably won’t mention that YOU are part of the experiment.

A little proof…a lot of money

Most patients who begin taking a new fast-tracked cancer drug will never realize the phony hype that drives the market for these barely-researched treatments.

Here’s how it works…

When a new cancer drug does well in a preliminary study, the drug’s maker promotes it to the FDA as a life-saving miracle drug that needs rushed approval.

So FDA officials take the drug company’s money (yes, the agency gets a nice fat fee for their stamp of approval) and green-lights the drug.

Come and get it! Start the life-saving!

But just one thing…

Each one of these over-hyped, over-priced “life-savers” is actually a big question mark. So drug companies have to agree to immediately begin new research to determine if the drug actually does what it’s supposed to do without causing grave side effects.

Well…that’s the idea anyway.

Running on empty

They hypocrisy of the fast-track cancer-drug program was on full view at a recent FDA meeting. Drug company executives were asked to appear and explain why required post- marketing studies had not been completed for six cancer drugs that received fast-track approval.

Three of those drugs were approved in 2004, and the FDA is STILL waiting for the post- marketing studies!

The Wall St. Journal notes that the agency has the power to revoke approvals and/or fine companies millions of dollars for not getting those follow-up studies underway.

So what did FDA officials do at this meeting?

I’ll tell you what they didn’t do: They didn’t revoke any approvals, and they didn’t levy any million-dollar fines. The WSJ says they “spoke generally about the value of timely confirmation.”

Wow! That must have had the drug companies quaking in their boots!

At the meeting, drug company reps explained that enrolling study subjects was often difficult because many patients didn’t want to participate in studies for drugs that were already approved (presumably because they don’t want to risk getting the placebo).

Which sounds like a sly way of blaming the holdup on the FDA. The companies are basically saying: “If you hadn’t approved the drugs, we’d be able to do our jobs and finish the study.”

Meanwhile, they go right on selling many of these drugs at exorbitantly high prices.

What a scam!

If your doctor suggests you start taking a very promising new cancer drug, ask him to show you the research that backs up those promising results.

Sources:
“FDA Says Drug Firms Didn’t Finish Follow-Ups” Alicia Mundy, Wall St. Journal, 2/9/11, wsj.com