Sunday, October 21, 2007

Spurious Reasoning about Pharmaceutical Ethics

A recent New York Times Op Ed by Peter Pitts, President of the controversial Center for Medicine in the Public Interest, attacks the idea of federal funding for studies that compare drug effectiveness in terms that will soon show up in drug company lobbying.

In a breathtaking piece of spurious reasoning, Pitts argues that because Medicare would probably not pay for costlier medications if cheaper ones were equally effective – an enlightened and fondly-to-be-hoped-for policy – it is a conflict of interest for the National Institutes of Health and other government agencies to fund comparative effectiveness studies.

It is entirely reasonable to criticize specific comparative effectiveness studies on methodological grounds. That is what science is all about. But Pitts dismisses the very concept of comparative effectiveness studies as “flawed.”

Pitts speaks of “cost concerns” as if caring about cost is the devil’s work. He is dead wrong. To make health care more widely available, to fund other social priorities, and to allow U.S. industries to be more competitive, we need clinically informed, ethically guided health care cost containment. Ethical physicians should join together to set limits on which drugs will be paid for by insurance funds, and to ensure that a robust process for appeals and policy revision is in place.

Pitts argues against cost containment by invoking the bogeyman of Medicare “forc[ing] doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.” The implied premise is that whatever any individual physician prescribes is, by definition, what is best for the patient. No informed person really believes this. There is huge variation in prescribing practices. Evidence is one source of prescribing behavior. Patient demand, often fueled by direct to consumer advertising, is another. Drug company sponsored dinners, speakers, seminars, and holidays, is still another.

We can’t leave the key to spending insurance funds in the hands of every individual physician without oversight. That oversight should come from expert medical guidance. Fair process in setting needed limits is what a Center that is truly “for Medicine in the Public Interest” should be lobbying for, not anything goes prescribing.

The fact that the Center for Medicine in the Public Interest is partly funded by drug companies does not invalidate Pitts’s arguments. But the combination of spurious arguments that favor unbridled prescribing and drug industry funding does not pass the sniff test.


Ian M said...

Hi Jim,
I think an important component in reigning in the costs of these newer medications will be the passage of legislation that restricts how the manufacturer may market the product upon initial release. As recently as this June, Congress was mulling a bill that would place strict limits on just how the pharmaceutical companies could advertise during the first 2 years of a medication’s availability to the public. Essentially, the bill would prohibit the type of advertising that consumers have grown accustomed to (television, radio, and print), and would allow product placement in trade journals and other outlets directed at those in the medical field. With the cost of bringing a drug to market now being roughly $1 billion, and various reports citing 15-20% of that cost being spent on advertising and marketing, substantial savings could be garnered by placing some such restrictions on advertising. When you add to this the fact that this 2 year window (or something of the like) will only add to the “learning curve” by severely limiting consumer demand unless warranted by strong clinical performance, I believe this is a measure that has to be strongly considered

Jim Sabin said...

Hi Ian -

Thanks for bringing up this piece of legislation. Limiting the direct to consumer advertising for new drugs could be a viable compromise between our current anything goes situation and a more blanket prohibition. In my clinical practice I have generally encouraged patients to "let this new drug show its stuff for a while" before trying it. A two year moratorium strikes me as an excellent idea.