Do Drug Regulations Really Serve The Best Interests Of Patients?
The most recent edition of the Glenn & Helen Show podcast features an interview with Richard Epstein, a law professor from the University of Chicago, regarding the pharmaceutical industry and how government regulation stifles innovation. Mr. Epstein has written a book about those issues and much of the discussion was centered around his findings that the pharmaceutical industry is over-regulated to the point that our progress in developing new drugs is measurably slowed. I found it interesting for a variety of reasons....not just because of his comments regarding nationalized health care.
It should be pointed out that the United States generates a disproportionately greater number of new medical technologies, techniques, and pharmaceuticals than compared with the rest of the world. One significant reason for this disproportionate American productivity in the medical arena has to do with the amount of regulation to which European drug companies are subjected. As a result, many drug companies have moved to the United States to continue their research.
And this guy thinks American companies are over regulated.
Glenn, Helen, and Mr. Epstein discuss the differences between how new medical procedures are regulated and how new drugs are brought to the market. With medical procedures, doctors have a fair amount of leeway to try something new. If it works, then that information is shared with others who also try it and the general knowledge base of medicine grows.
This is a bit of an over-simplification. There are some regulations that do have to be followed. But they are not nearly as restrictive as those that apply to new drugs.
With drugs, there are extensive research programs that have to be conducted. Then there are lengthy and costly clinical trials that have to be conducted in order to persuade FDA regulators that a given new drug is "safe" and "effective".
There is an extensive discussion about how patients and their families perceive risk and benefit as opposed to how FDA regulators perceive risk and benefit. This discussion naturally leads to the rise in patient advocacy groups that have been demanding immediate access to all sorts of drugs. In particular, AIDS patient advocacy groups have been very effective at getting such access and then immediately sharing the experimental drug results with one another.
Effectively, a patient that will die in three years cannot wait for a five to ten year drug development and approval process. That is the basis for a terminally ill patient's risk/benefit analysis.
On the other hand, FDA regulators face all sorts of media criticism if they choose to let a drug on the market that isn't 100% safe and 100% effective. Regulators evaluate risk/benefit from a much different position.
Mr. Epstein makes the case that people can sue drug companies for selling flawed products, but that they can't sue market advisors, the media, and regulators when it turns out that their opinions about safety and effectiveness delay or prevent bringing a new drug to market. As a result, in Mr. Epstein's opinion, such third party opinions ought to be discounted in favor of the opinions of people that are directly affected by the decision to sell a given product; patients, their families, doctors, and investors.
Mr. Epstein is of the opinion that "profit" is not a dirty word. Wisely so, in my opinion.
And finally, Mr. Epstein makes the point that he isn't opposed to the FDA and reasonable regulation. He says that there clearly is a role for the FDA to ensure that all sorts of bad things do not end up in the medical supply chain and that drug producers are being honest and forthright about what they are selling.
I can't say that I agreed with everything that he said during the interview. There was some brief discussion about collusion between manufacturers being acceptable based on market conditions that I'm not sure I agree with. I would need to know more to say more.
Listening to this podcast made me think of the vastly different approaches to regulation that are applied to vastly different markets. For example, telecommunications regulators are currently considering changing regulations so that cell phone companies would no longer have a monopoly on supplying telephones. This would essentially allow third party suppliers of new technology to sell cell phones to customers who would in turn be able to purchase connection to a cell phone network from a cellular company.
The proposed change effectively forces telecommunications companies to accept/adopt new technologies at a faster pace. The end result being faster deployment of new technologies and reduced prices for consumers.
On the other hand, we have FDA regulators that tend to slow the pace at which new medical advances are brought to the market. As a result, patients have a longer wait for new technologies and pay very high prices when they finally hit the market.
Mr. Epstein had some other very interesting observations. The podcast is worth a half hour of your time.
by Dann
|