Wednesday, September 10, 2008

Why Merck’s Problems are Also Your Problem

Will Vioxx never go away?

It has been four years since Merck withdrew the COX-2 inhibitor. It is a full year since Congress enacted legislation intended to “fix” the drug safety problems highlighted by Vioxx.

But Vioxx is still in the news. Now, the focus is on how the product was marketed. Academic journals, mining product liability dockets, are highlighting instances of “ghost writing” and “seeding studies” involving the product. The media gleefully piles on.

If you don’t work for Merck, you may be tempted to think none of this much matters. (Except perhaps as an occasion for schadenfreude, if the unrestrained glee of these posts is any indication.)

We’ve written before about the far reaching impact of a damaged reputation, and specifically about the implications of the blemishes on Merck’s once-stellar image as the drug company that does things the “right way.”

But Merck’s problems are not just Merck’s problems. The damage to Merck’s reputation is the whole industry’s problem.

Here’s why: Just as Vioxx was the short-hand explanation for a whole host of drug safety changes—most of which, both Merck and its harshest critics agree—had nothing whatsoever to do with the drug, now it is a short-hand for everything that people object to about industry marketing practices.

And Vioxx’ potency as a weapon against the whole industry is all the greater because it was sold by Merck.

One example came during the Food & Drug Law Institute advertising & promotion conference September 8, when Ann Witt, a former FDA ad division head who is now an advisor to Congressman Henry Waxman, discussed Waxman's opposition to a proposed guidance that would allow companies to disseminate peer-reviewed journal articles on off-label uses:
"There are many many examples, and unfortunately there are more coming to light every day, of company-manipulated data that ends up in peer reviewed reports. I’m sure we’ve all followed the somewhat distressing trail of evidence that is coming out about how Vioxx was promoted. There have now been at least four or five separate articles on the different methods that Merck used to manipulate study results."

"I--who have spent probably 20 years following drug advertising and thought I was pretty cynical about it--I found the stories about Merck personally extremely depressing. I would imagine many of you do. "

"I, like many people at FDA, always thought of Merck as sort of the gold standard in the industry, and to find that this kind of really irresponsible marketing and distortion of the scientific record was so pervasive there is truly troubling."

"I would hope that it would lead all of us to question whether substituting peer review, for FDA review and approval, is really a good way for doctors to learn about new uses of drugs."
In other words, if Merck does it, then everybody must do it.

And consider the context: Witt is citing allegations against Merck to block a guidance on off-label journal reprint distribution. That is an issue that is of far less significance to Merck than to dozens of other companies with more prominent positions in oncology, pain or other markets where off-label uses are essentially standard practice.

That is how it works. Companies that never marketed a COX-2 inhibitor have to live with mandatory post-marketing studies and Risk Evaluation & Mitigation Strategies. They may also have to live with a whole host of new marketing restrictions—whether enacted by Congress or simply created by more aggressive enforcement at FDA.

1 comment:

Dan said...

Thank you Milanda Rout at “The Australian” for your dedication in sharing with the world what is happening with this trial.

The Australian has done a wonderful job exposing what were tacit tactics utilized by Merck to promote Vioxx.

The class action trial began in Melbourne at the end of March, and is predicted to last three months.

This would not have happened in the U.S., I'm sad to say, this kind of exposure.

I launched Vioxx as a representative with Merck back in 1999.

Aside from looming patent experations from two of Merck’s ACE Inhibitor hypertension drugs, Vasotec and Prinival, as well as their first statin drug, Mevacor, this drug was very important to Merck for two other more concerning reasons:

One is that Lipitor, which was approved in 1997, rapidly acquired the lion's share of the statin market (Merck has the lion's share of this class of medications with Zocor before this happened).

Merck was not prepared for this rapid uptake of Lipitor, and this vexed Merck greatly.

Secondly, Vioxx got approved 6 months after Celebrex, and this concerned Merck.

Historically, the drug that is first in class that gains approval first will capture the lion's share of the market, and maintain the lead over the competitors- in this case, the Cox II class of medications.

Celebrex getting approval before Vioxx concerned Merck as well. So the plans implement read almost daily in The Australian are plans that were implemented in the United States as well.

Merck was desperate, and clearly was willing to cross ethical lines to assure Vioxx would be the success that Merck needed it to be due to competition.

What we read about this trial that continues is accurate, even though merck is saying in defense that most of we read is 'mis-statements', or embellishents.

What we read is true, and the ethically if not legally corrupt plans of actions implemented by Merck were with deliberate intent and reckless disregard as they continued to strive to gain additional market share with an unsafe drug of theirs.

Dan Abshear