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Monday, January 22nd 2007

Direct To Consumer To Get Redirected Through Washington

Medical Rants is one of my favorite blogs. I started reading Dr. Centor when I was applying to medical school and through the years (scary to imagine it is almost three years since my application went in), he’s provided a great point of view and baseline for considering plenty of issues that will face me one day as a physician.

But when it comes to DTC, I could not disagree with him more. He’s commenting on a New York Times article,

Both the industry and its critics agree that there should be a pause before the advertising starts — to allow time for doctors to learn about a new drug. The companies want the delay to be left up to them, but critics say the F.D.A. should require a wait of up to two years. Criticism of direct-to-consumer advertising has intensified since 2004, after Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.

[The Pharmaceutical Research and Manufacturers of America] organization issued voluntary guidelines for consumer ads, which took effect last year. Under the guidelines, the companies have promised to hold off on consumer advertising of a new medicine for an unspecified “appropriate” period. That would allow time to tell doctors about risks and benefits, before television and Web site viewers see an ad and demand a prescription.

Twenty-seven members of the pharmaceutical manufacturers organization have endorsed the guidelines, but it is hard to figure exactly how long the delays in advertising will run. Bristol-Myers Squibb has said that it would delay for 12 months. Johnson & Johnson and Pfizer said they would wait six months. The manufacturers group cannot say how other companies have interpreted the guidelines, a spokesman said.

But according to TNS Media Intelligence, the companies have actually been waiting 15 months, on average, since the Vioxx debacle.

Now we’ll see if Congress will place a mandatory restriction on DTC advertising on new drugs or perhaps ban DTC ads altogether.

F.D.A. regulators would be granted the power to require moratoriums under a bill sponsored by Senators Edward M. Kennedy and Michael B. Enzi, the chairman and ranking Republican member of the Senate Health, Labor, Education and Pensions Committee.

In anycase, Dr. Centor is very much in the majority with his opinion on this matter,

I hope Congress has the fortitude to stop this nonsense. Now I expect to hear about free speech, but remember free speech does not give one the right to yell “Fire” in a crowded movie. Your free speech ends when it can do real harm to patients.

I’m not speaking to what the law is, I have no idea about how any court decision would come down concerning a restriction on pharma ads. I’m talking only about what I think we should do.

To begin, I think commercial speech should be protected as much as private speech. Only a misrepresentation or exclusion of the facts in an ad should have penalties, and often times (as it is now) those penalties should be sought in a civil procedure.

So while I have no trouble with the massive pay outs by Tobacco companies concerning knowing the harms of smoking and not disclosing them (and might have even jumped on board of criminal prosecutions of those who covered up such data), I will stand up and say, despite the unpopularity, that I believe…

…Joe Camel On Television Should Be Protected Speech

I certainly don’t believe that DTC rises to the level of crying “Fire” in a crowded building, as Dr. Centor seems to. The standard on when to put prohibitions on speech must include imminent danger. The bar has to be set very high, because this right (even the right to run TV ads) is far too important.

Certainly it is difficult to consider these ads an imminent danger, considering:

a) The patient still has a very real choice
b) There’s a huge protection (or their should be) in the already existing restrictions that exist in the patient actually getting the med. I’m speaking of course about the physician’s power of the pad.

Why are physicians given authority over prescription drugs if not to protect patients from themselves?

I know the argument that physicians prescribe drugs. Drug companies would not run these ads unless they had a positive impact on sales. While I would like every physician to make decisions independent of drug ads, drug reps and patient requests, I am a realist not an idealist. We should regulate these dangerous influences on our decision making.

Everyone concedes these ads work. That speaks more to the physician and patient populations than anything.

Believing that commercial speech is an inherent right, how can I even consider the argument that simply because these ads make life harder for physicians or physicians are too human to make independent decisions that the solution is to curtail this right?

No, the burden has to be with the physician and the patient. We pretend as if the modern ad agency, the squawk box, and other influences have denied us any semblance of free will. I swear I put the campaign against DTC advertising right up there with something like this in terms of an attempt to escape from self-responsibility.