Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward
(Posted by Tom Lamb at DrugInjuryWatch.com)
The September 1, 2007 edition of Pharmaceutical Executive starts with the piece "From the Editor: What Do You Say?" which carried this intriguing sub-title: "The first safety signal is detected. Proof or disproof is literally years away. What has to happen so no patient will say, 'You hid the risk'?"
For a lead-in on this piece, however, we draw from an October 15, 2007 post by Ed Feather "The Vioxx Moment" over at the ART + science: the PARTNERS+simons Blog:
Patrick Clinton, Editor-in-Chief of Pharmaceutical Executive magazine, uses the terms "the Vioxx moment" and "the Avandia moment" in his September 2007 "From the Editor" column. He describes these as "the moment when a safety signal has been detected on a drug, and no one yet knows for certain whether it is real or not – the moment when pharma companies and FDA alike set themselves up for a kick in the teeth." In other words, do we tell people that someone died while taking our drug, or should we wait to see if anyone else dies?
Returning to this September 2007 Pharmaceutical Executive piece, Mr. Clinton is a bit (not surprisingly) biased toward Merck and Big Pharma when using the Vioxx experience to consider how one should properly handle an emerging drug safety issue, but his depiction serves its purpose:
The drug was approved in May 1999. In March 2000, the drugmaker announced preliminary results of the VIGOR trial, which was designed to test the gastric effects of Vioxx, but instead suggested that the drug was causing cardiovascular problems. The trial wasn't set up to test for CV side effects, so the results were ambiguous: Maybe it was just showing that naproxen, the drug Vioxx was tested against, was cardioprotective.
Roughly a year later, an FDA advisory committee meets to discuss the results, and roughly another year later, Vioxx's label is changed. And two and a half years after that, the APPROVe trial testing Vioxx for its effect on colon polyps is halted because it's finally clear that Vioxx is causing heart attacks and strokes.
You remember what came next: an endless litany of "Why are we only hearing this now?" That perception—that the period between first discovery of a safety signal and scientific confirmation of a safety problem is basically a cover-up—has had a shocking effect on the credibility of the industry and of FDA. And as things stand, we can expect something similar to happen over and over. As researchers develop more powerful tools, we'll see more safety issues with more drugs emerging in the postmarket phase. And most issues will be sufficiently ambiguous that they'll require further research. They'll trigger a Vioxx moment.
In closing his editorial, Mr. Clinton proposes one possible approach for drug companies and doctors to address this drug safety signal predicament:
I suspect the answer will include both a standard format for reporting safety signals to the public—one that assesses the validity of the evidence and provides a realistic estimate of how long it will take to get more—and perhaps even some sort of informed-consent procedure. That would be a burden to physicians, patients, and pharma alike. It would certainly frighten some patients out of taking their drugs and some doctors out of prescribing them. But that may turn out to be the price of trust.
The execution may prove difficult, but the goal is simplicity itself. No patient should ever be able to say of a risky drug, "You knew, and you didn't tell me." For everyone's sake, that must be utterly nonnegotiable.
And returning to "The Vioxx Moment", Ed Feather -- who says therein that he worked for GlaxoSmithKline in the past and was involved with the marketing of Avandia -- provides some parallel good advice for those advertising agencies that work for Big Pharma:
As marketers, it is our responsibility to ensure we do everything we can to be truthful. While the goal is to sell more product, it should not be at the cost of public faith in medicine, nor at the cost of lives. We must ensure that we include ALL of the safety information in a clear format that everyone can understand.
Print and online media generally afford the space for longer disclosures of safety information. But with TV we may find ourselves foolishly searching for ways to shorten the fair balance while staying within FDA regulations. In the end, if the safety information is not clear, and someone misses an important, life-changing piece of information, you have failed.
My advice: stick with integrity. Do it right the first time. Continue to elevate a positive profile for the pharmaceutical industry. And help healthcare providers, and their patients, make the right medical decisions based on ALL of the necessary information.
Consistent with these two thoughtful pieces, let's hope that the lessons of Vioxx do not go unheeded and that drug safety will continue to improve here in the U.S. and around the world.