Did you hear the one about the PhRMA guidelines?

Last summer I sent you an e-Alert (“Barbarians at the Garden Gate” 6/27/02) about the new marketing code of the Pharmaceutical Research and Manufacturers of America (PhRMA), designed to govern the pharmaceutical industry’s relationships with physicians. The sweet ride was over, PhRMA said, because its new set of strict guidelines detailed exactly how far a drug salesperson could go to influence physicians to prescribe, prescribe, prescribe, and (when in doubt) over-prescribe.

But PhRMA is an advocacy group for the drug industry. They have no regulatory power, so the most they can do is to ask salespeople to stick to these guidelines on a voluntary basis.

So how do you suppose that’s been working out?
Influence – bought & sold

The new “PhRMA Code on Interactions with Healthcare Professionals” started off with two strikes against it: ten years ago the American Medical Association initiated similar guidelines (which nobody followed); and the PhRMA guidelines are filled with language that provides plenty of loopholes. Under these circumstances, it’s easy to imagine how pharmaceutical companies might not be motivated to voluntarily pull back on the methods they’ve used for many years to influence and persuade their clients.

Even though the new code has been in effect for only two and a half months, the “Newark Star Ledger” decided to get the jump on everyone, reporting that some doctors claim the guidelines are being ignored. For instance, one of the PhRMA rules calls for drug salespeople to treat healthcare providers to only modestly priced meals. But the drug giant GlaxoSmithKline recently booked an expensive French restaurant to host a lecture for doctors from the University of Pennsylvania Hospital.

Similar incidents of other drug companies stepping over the PhRMA guidelines have been reported by doctors at the U. Penn Hospital. And although the Star Ledger highlighted only these isolated events, I believe we’ll be hearing similar reports from other sources nationwide. And, really, did we expect not to? The PhRMA guidelines have no teeth. Their primary purpose is public relations: to show the world that the industry is at least making an effort. But while PhRMA is sending a message to the public, I hope the word is getting through to the one group that most needs to hear and understand the concept that influence should not be bought and sold: the doctors.

I’m convinced that the pharmaceutical industry can only be regulated by the health care professionals it serves. When a drug salesperson attempts to influence a doctor with gifts and other perks, there are two parties present at that point of contact. If a doctor accepts the special offers of a salesperson and in return prescribes patent drugs instead of less expensive generic drugs, that doctor is serving himself and the drug company. Meanwhile, his patients – who trust him to provide the best quality care at the lowest cost – are not being served. But if the doctor simply refuses the gifts and perks, then the problem vanishes along with the need for unnecessary regulations. Needless to say, when your doctor prescribes a name brand drug, you should always ask if a generic is available.

Whistle blowing

 

But I don’t want to let the drug companies off the hook here. Time and time again they’ve demonstrated marketing practices that would make an organized crime boss blush.

In last Thursday’s e-Alert (“Taking Pity” 9/19/02) I told you how the drug companies are not above flexing their economic influence and leaning on business partners outside of their industry who might be inclined to support legislation unfavorable to the pharmaceutical conglomerates. Last week I also came across an article with this chilling headline: “Insider: Drug Safety Not FDA Priority.” And guess who’s right in the middle of this story, doing everything they can to press the FDA to speed along approvals of new drugs while downplaying safety issues. Did you answer “drug companies”? Right on the money!

The “insider” mentioned in the headline is Paul Stolley, M.D., M.P.H., a former FDA advisor who served as an FDA safety-consultant for two years. Now he’s blowing the whistle, charging that the drug approval process is heavily influenced by drug companies who pay “product review” fees. Among other claims, Dr. Stolley says that the drug giants fully expect the reviews to speed through as quickly as possible in return for the payment of these fees.

I’m sure this story will soon be followed with additional rebuttals and accusations. So I’ll keep watch for further reports, and then I’ll bring you a full accounting of Dr. Stolley’s insider-insights.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

 

 


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