Thursday, February 10, 2011

Are we seeing a concerted drug industry campaign against the FDA?

There must be something in the air. Either that, or the drug and medical device industry has embarked on a concerted campaign to improve its tattered public image and bully the FDA into backing down from recent efforts to ensure that unsafe drugs and medical devices are kept from the market.

First appeared an op-ed piece in The Boston Globe early this week complaining that the average number of new drugs approved by the FDA since 2005 has dropped 33 percent and urging the FDA to once again speed up the process. The op-ed was penned by none other than Christoph Westphal, a biotech entrepreneur who made a mint when he sold his startup, Sirius, to GlaxoSmithKline in 2008 for a whopping $720 million.

Then comes a double whammy today in The New York Times: an op-ed piece by a former vice president at Merck calling for Congress to allow drug companies to work with other on joint direct to consumer advertising campaigns (as if the current barrage of television drug ads isn't bad enough), and an article in the business section decrying regulatory delays of medical devices and arguing that this slowdown is forcing some patients to go overseas. The article by Andrew Pollack raises the old canard that the pharm industry brings up whenever it wants concessions: that U.S. industry will lose its global competitive edge if the FDA doesn't relax its regulatory standards.

In his op-ed piece in The Globe, Westphal specifically criticizes the FDA's recent rejection of a drug to treat obesity, even though the agency had serious concerns about the drug's effectiveness and safety and its possible over-use as a treatment of first instead of last resort. He then goes on to urge $1 billion in additional funding by the federal government for early and late-stage drug development. The implication is that taxpayer money would be well-spent by supplementing research funding by the industry, which now pretty much controls drug testing and development with all the resulting conflicts of interest. Now, I would love to see the NIH take over control of clinical trials for new drugs if only to ensure less biased trial results and have blogged about that before. But somehow I don't think such independent research is what Westphal has in mind.

Speaking of possible conflicts, Westphal seems to have become a regular guest contributor to The Globe's op-ed page, which is interesting because his wife, Sylvia Pagan Westphal also is a regular op-ed contributor to the paper on medical issues. (I'll give Westphal this much: he's a brilliant marketer. He sold Sirius to GlaxoSmithKline on the promise that its one product, resveratrol, a basic ingredient in red wine, would become an anti-aging bullet. Yet just last year GlaxoSmithKline had to stop a clinical trial of resveratrol after a number of patients taking it developed kidney failure).

The Times' op-ed piece, disingenuously headlined "Better Drug Ads, Fewer Side Effects," essentially argues for weakening anti-trust regulations to allow the drug companies to work together on joint advertising campaigns that, in my mind, would be even more misleading than the television ads now dominating the air waves. The author of this piece, the former Merck exec who now works for law firms that represent drug companies, argues that these joint ads would inform consumers about diseases and treatment options (including drugs) and spare viewers "the assault of promotional messages, often unintelligible warnings about side effects and cloying images..." Yes, we could all do without the cloying images, but I guess I'd rather have unintelligible warnings than no warnings at all. Better yet, as I've blogged about before, what would really protect consumers is if Congress passed legislation prohibiting all direct to consumer advertising by pharmaceutical companies, period.

Why is the industry mounting what looks like a carefully orchestrated campaign to sway public opinion now? Perhaps because its lobbyists smell blood in the water. The House is now under the control of pro-business Republicans, and in recent weeks, even President Obama has gone out of his way to cozy up to big business interests. So industry officials must think this is the time to put pressure on regulatory agencies like the FDA, which in the last few years has shown an increased willingness to hold new drug and medical device approvals up to a higher level of scrutiny for safety and effectiveness. I just hope that, in the interest of public health and safety, the FDA stays strong.



Unknown said...

I hope the FDA becomes an Ethical Regulatory Agency---it has very little integrity with so many individuals with major "Conflicts of Interest" on it's "advisory" committees.

Failing to hold individuals accountable for off-label drug use--failing to REQUIRE doctors and other prescribers to report adverse events--even death caused or related to prescribed drugs used for approved or not approved uses--seriously undermines the ethical collection of safety data. How can this oversight be anything but intentional?

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