Friday, May 25, 2007

'Round the Sphere: Health Care Renewal Rebuffed by In the Pipeline on Avandia

Seems like Derek Lowe over at In the Pipeline and a few other people as well are detecting a hidden "agenda" at the Healthcare Renewal blog.

It started with PharmaGossip recommending an article on Avandia at the Health Care Renewal site, calling it "essential reading". The article in question is "Expanded Avandia Story Now Echoes Familiar Themes."

In the article, the author, Roy M. Poses MD, compares the Avandia case to the Vioxx case and cites these "familiar themes":

  • Early warnings from at least one whistle-blower were apparently ignored.
  • The pharmaceutical promoted the drug enthusiastically, apparently again in a way designed to distract attention from particular adverse effects.
  • Just to muddy the water, the whistle-blower had financial relationships to manufacturers of competing drugs, possibly leading to questions about whether his whistle-blowing may have been influenced by them.
I also warned that GSK may be following the same path as did Merck (see GSK May "Step Into the [DTC] Void" to Defend Avandia and Advice to GSK on Handling the Avandia Avalanche: Don't Do What Merck Did). Peter Rost went so far as to call me "stupid" for giving GSK free advice, but I know he meant that in the nicest possible way.

Anyway, Derek had this to say:
"[The] article has some good points in it, but to my ear they're phrased oddly. For example, it advocates a skeptical attitude toward the marketing claims made by drug companies, which is very good advice. But that's very good advice for evaluating the marketing claims of companies in every other industry, too. They're trying to sell you something. They will present their product in the most favorable light possible, whether that product is a car, a diabetes drug, or a burrito.

" of the things that I dislike about the Health Care Renewal piece is the hand-rubbing now-we've-got-'em tone that I detect in it. You don't have to go far to find it from plenty of other sources, either, which is why people like me are perhaps too touchy on the subject."
[You can find Derek's complete post here: More Avandia, And More on Marketing]

What I found disturbing about the Health Care Renewal piece is the following claim that Dr. Poses made:
"Once again, it appears that a drug company was pushing one its products beyond what the clinical research evidence supported."
The way I interpret this is that GSK made efficacy (benefit) claims beyond what the evidence supports. This is different than saying it tried to gloss over the adverse side effects, which is what the FDA warning letters (mentioned in the NYT article) say. The FDA never, to my knowledge, claimed that GSK was making unsubstantiated benefit claims.

This is an important distinction, because any decision by the FDA to request that Avandia be taken off the market will be based on how the risks stack up against the benefits. Other commentators -- including Bob Ehrlich -- also point out that the benefits of Avandia may outweigh the risks:
"In my view, here is another useful drug accused of being dangerous in the unrealistic desire for risk free medications...Properly warned, patients and their physicians need to weigh the risk and benefits of any drug. In some of those carefully considered cases, patients will still die because of a reaction to a drug intended to make them better. That has and always will be the case. Those deaths pale in comparison to lives saved. That part of the story gets lost because 'greedy uncaring drug company' makes better copy." [DTC Perspectives Issue 262]
I am not sure that Avandia's risks outweigh its benefits, but if intelligent bloggers -- and MDs to boot! -- can't get it right, then God help patients who need to make a decision!


insider said...

Your last couple of paragraphs are my point exactly.

Avandia (and Vioxx, possibly) may be good medicine for a small sub-group of patients - but should not have been "pushed" by mass marketing for all patients with diabetes (or OA in Vioxx's case).

R&D's success has been turned into failure by "over-Sales&Marketing" due to Senior Management greed/need for a blockbuster.

PharmaGuy said...

I acknowledge your point, which would put the FDA squarely in the middle -- it could have limited the indication to a subset of patients or excluded a subset, such as patients with with CHF -- in fact, the Avandia label includes data showing that Avandia can have adverse effects on people with CHF.

Perhaps physicians are partly to blame also fo not monitoring their patients closely enough. Maybe even patients who don't read the patient section of the label (which is easy to read as opposed to the technical part of the label designed for the physician).

Only so much blame can be placed on the drug company for unduly influencing physicians and patients, which is not to say NO blame should be placed on GSK, only that there is enough blame to go around and it's time that regulators, physicians, and, yes, patients, step up and accept some responsibility!

In our jaded society it's too easy to blame the bogey man, big bad pharma, greedy corporate executives, marketers, or anyone else rather than oneself. Let's grow up already!

Anonymous said...

Nice observation, thanks.