2012-07-10

Who Pays For A Botched Job?

Yesterday, The New York Times reported on the FDA's recent decision on pain medications. Summarizing the FDA's conclusion, the Times writes as follows:
The Food and Drug Administration, overriding the advice of an expert panel, said Monday that it would not require doctors to have special training before they could prescribe long-acting narcotic painkillers that can lead to addiction.

But the agency said companies that make the drugs, like OxyContin, fentanyl and methadone, would be required to underwrite the cost of voluntary programs aimed at teaching doctors how to best use them.
Emphasis mine.

Let's Add Some Context Here
When pharmaceutical companies engage in programs designed to teach doctors how best to use their own products, they are engaging in a practice called Detailing. Detailing is an industry term. Typically, the pharmaceutical sales rep - perhaps accompanied by a small team of subject matter experts - schedules a ten-minute appointment with the doctor, summarizing the product's best practices, mechanism of action, and prescribing recommendations.

It has long been the opinion of critics of "Big Pharma" that detailing is one of the ways Big Pharma distorts the scientific information and misleads doctors into believing something that is not supported by the evidence.

Is this true? That is tough to say. There are inherent conflicts of interest here. The pharmaceutical companies have every reason to make their products look as good as possible when they're visiting prescribers. On the other hand, doctors have every reason to more favorably weigh information coming from a sales rep with whom he/she has a good working relationship than when that information comes from outside sources. In general, I think it's safe to assume that the reps - whose job it is to make drugs look good - present only a good case for their drugs. I think it's also safe to say that doctors have more incentives to listen to Detailing than to spend all their free time scouring the clinical literature for all new drug information.

The Plot Thickens
In other countries - Canada, for example - government agencies, and quasi-government agencies (such as CADTH) engage in counter-detailing practices. They call this Academic Detailing, and during these sessions, government bureaucrats schedule appointments with doctors to provide similar detailing.

However, rather than pushing specific products, these detailers push cost-effectiveness research and so-called "evidence-based medicine."

Proponents of this kind of detailing suggest that it offers a more objective voice than doctors might get from Big Pharma. However, we must not pretend that it is objective information.

Suppose a very expensive - but very effective - new drug hits the market. Big Pharma's detailing projects will naturally promote the drug's efficacy among doctors. Government detailers, on the other hand, will present the opinion that, while the drug is very effective, a patient still gets "acceptable" therapeutic benefits from the next-cheapest medication.

Now the doctor must choose between the most effective medication and the one that makes economic sense to the government. The cost evaluation is no longer being done by the patient. The doctor makes the ultimate cost decision.

Is this fair? Shouldn't patients have a say in the matter?

Looking Forward
As you can see, just because the government provides the information doesn't mean it hasn't distorted the healthcare landscape. But that is Canada. What about the United States?

This recent FDA decision indicates that the government does not want doctors to have to educate themselves about pain medication prior to prescribing them. This seems ludicrous, doesn't it? I would speculate that the FDA's rationale has taken into account the fact that doctors would pass this cost on to consumers, the largest of which is the Federal Government. The government doesn't want to pay more money, so they are insulating themselves from the cost.

There is also a long-term game at play here. Pharmaceutical companies are already engaged in Detailing, therefore the FDA's decision doesn't actually cost Big Pharma any additional money.

Instead, the FDA has set a precedent for Detailing. While the government may not be able to afford additional training for all doctors in the country, it can certainly earmark funds for grant recipients who are willing to conduct "Academic Detailing" on behalf of the government.

We know this will happen because it already happens in every other rich country in the world. To use more inflammatory language, the "Death Panels" will be going door-to-door, visiting every doctor in the country, "teaching" them the government's message about which drugs to prescribe and which not to.

I reiterate: This already occurs in other countries. This is not pure spook stuff. It happens all over, and it will happen here. What we're seeing with this latest development is merely the early roots of CER and "evidence-based medicine."