The FDA demonstrates how to botch the approval of a disastrous new drug

Crash on the Fast Track

How do you completely botch the approval of a cancer drug and put thousands of desperate patients at increased risk of death while wasting their money?

The FDA and Wyeth have kindly given us a master class in All the Wrong Moves.

First you develop a drug that promises to be a genuine lifesaver. That was the hype, anyway, back in 2000 when Wyeth asked the FDA to give accelerated approval to Mylotarg.

You’ve probably never heard of Mylotarg because its use is so specific. It’s designed to treat a relatively rare type of blood cancer called acute myeloid leukemia (AML), which occurs mostly in people over the age of 60.

Early tests suggested that Mylotarg use might improve remission rate, and increase overall survival by a few months.

So the FDA gave the drug accelerated approval, but only for patients who had suffered a first relapse of AML and weren’t eligible for other chemotherapies. And as with any drug approved on the fast-track program, Wyeth was required to mount further research.

And this is where things started to go off the rails.

It took Wyeth four years to begin the follow-up Mylotarg study. Four deadly years.

Fast forward…

Wyeth is no more. They were purchased by Pfizer in 2009. But the Mylotarg study they started years ago continued.

Until last month.

One full decade after Mylotarg’s hasty approval, Pfizer abruptly stopped the study and took the drug off the market for two reasons: 1) Mylotarg use showed no benefit, and 2) Compared to patients who used standard therapy, it appeared that patients who used standard therapy plus Mylotarg were FOUR TIMES more likely to die during the study!

Meanwhile, this dangerous, poorly-studied drug made millions for Wyeth and Pfizer.

Business Week reports that the sales of Mylotarg in the first quarter of this year were nearly $9 million. But only about 2,500 patients have been using Mylotarg each year.

Don’t reach for your calculator–I’ve already done the math. Apparently, each patient paid more than $14,000 for the required two injections of a drug that doesn’t work and might be fatal.

Now, by Big Pharma standards, $14,000 is nothing. That’s just walking around money. That’s hardly enough to buy off a politician.

But for most patients and their families, a $14,000 medical bill is a serious hardship. Nevertheless, you can be sure that many families who trusted the FDA were plunged into debt or raided their life savings to give their loved one every chance to live, based entirely on Mylotarg’s status as a promising miracle drug.

Ah well–la de da–file it under “lessons learned,” right? As one FDA official told Business Week, follow-up trials for fast-tracked drugs should probably be planned and “if possible” already underway when the application is submitted.

Gee, it seems like that would have been a really obvious detail to address TEN YEARS AGO!

To Your Good Health,

Jenny Thompson

Sources:
“FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market” FDA News Release, 6/21/10, fda.gov
“Pfizer Withdraws Drug After Deaths, No Proven Benefit” Catherine Larkin, Business Week, 6/21/10, businessweek.com