A disturbing note of sympathy for a drug giant that attempted to hide fatal dangers

Say Bye Bye

In the middle of a vast desert, a car pulls to the side of the road. The door swings open. We hear a voice in the car say, “Sorry, pal. The free ride is over.”

That voice is the FDA speaking to Avandia, the controversial type 2 diabetes drug.

In the end, FDA officials didn’t have the grit to actually kill Avandia. But they restricted its use so tightly that it’s like dropping it in the middle of nowhere, leaving it to die on its own.

From now on, this dangerous drug will only be available to patients who have unsuccessfully tried all other type 2 diabetes drugs, leaving them no other options.

Of course, this “last ditch” thinking doesn’t include the use of certain supplements that are proven to help many diabetics control blood sugar. No surprise there. I expected that. But here’s what I never expected: Avandia nostalgia. And it comes mixed with something even more surprising: a disturbing note of sympathy for a giant drug company that appears to have attempted to hide fatal dangers from consumers.

Criminal record

One study estimates that more than 47,000 Avandia users have suffered heart attacks, strokes, heart failures, or deaths while taking the drug.

But in spite of this appalling and shameful record, the New York Times actually seems almost wistful, pointing out that the Avandia story “marks a new and unsettling period for pharmaceutical companies…”

Really? Unsettling? Is it as unsettling as a heart attack or a stroke?

Executives at companies like Merck (they hid the dangers of Vioxx) and GlaxoSmithKline (they hid the dangers of Avandia) know what to do when a situation is “unsettling”– they send in their lawyers with bags of money. Done. Everything settles right down.

The Times adds that GSK was forced to post clinical trial data on its website as a result of a legal settlement.

Forced! Oh my. The poor dears!

The Times again: “Such public postings are increasingly the norm, which means that drug makers can no longer easily hide or control scientific information about their medicines.”

Now isn’t THAT a shame! No more easy hiding and controlling data. Now they’re going to have to work much harder to hide and control.

Cry me a river!

Finally, the Times laments the end of an era: “From now on, drug regulatory authorities are unlikely to approve medicines simply because they help diabetics control blood sugar levels–the standard for more than 80 years. Instead, authorities are likely to insist that companies prove that their medicines improve the quality or length of diabetics’ lives, a tougher test.”

Two thoughts…

First of all, if a company should develop a drug that effectively controls blood sugar without harming patients, believe me, quality and length of life will follow. But that “if” is the size of Texas.

And secondly, the only thing FDA authorities are likely to do is to continue doing exactly what created this mess: fast-tracking drug approvals and leaving the safety testing for later.

To Your Good Health,

Jenny Thompson

Sources:
“Regulators Impose Tight Restrictions on Diabetes Drug” Gardiner Harris, New York Times, 9/23/10, nytimes.com