Elsewhere I have stated my opinion that fully 50% of all health care spending could be eliminated with a combination of electronic records and diagnostic software. Electronic records would make it easy to use data-mining software to evaluate the success of different treatment regimes for various ailments. (If a patient knew there was an 80% probability of success with a $1,000 treatment and an 80% probability of success with a $1,000,000 treatment, which one would they choose?) Diagnostic software would help focus diagnosis, eliminating billions in wasted tests.

But as Kessler points out, the health-care industry makes more money when it consumes more resources. The bias of practitioners with an economic stake will always be to spend more. There are few, if any, practitioners with no economic stake.

This is, and will remain, a stubborn problem. If I Were King it would be no different. Better health insurance will not help, that just means that each patient has more resources available. The only thing that has a chance is a combination of patient understanding of the costs and benefits of different options, and an economic stake in choosing among them.

Should we spend a million bucks to keep Mom on life support for another six months? What if that means that nobody in the family will see a dentist for the next ten years? Clearly there are times when heroic (read: expensive) efforts are worthwhile, and times when they provide no more benefit than burning the same amount of currency.

We need better understanding of the costs and benefits, which open electronic records will enable, and then we need to empower patients and families, consulting with health-care professionals, to make judgments about the resources to be used. The industry’s motivation will always be towards growth in spending, I see no reason why we can’t cut that spending in half in the next ten years.

That is not to say that a doctor shouldn’t be able to hang up his shingle and define his practice in any way that suits him. If a surgeon opposes abortion and decides to open a practice specializing in ophthalmology, of course he shouldn’t be expected to perform abortions. But if that surgeon went to work in a clinic that provided abortions, and then refused to perform them while drawing his salary, then that doctor should suddenly, and without ceremony or honor, find himself unemployed.

In previous invocations of this concept it has been suggested that pharmacists should be able to refuse to fill prescriptions for drugs of which they disapprove, notably the “morning after pill” abortifacients. But what if a pharmacist was of the opinion, apparently held by many otherwise-sensible persons, that ADD is not really a disorder and that treating it with drugs is wrong? Should that pharmacist be able to refuse to fill prescriptions for Ritalin or Concerta or any of the other drugs that make life with ADD manageable? The answer is no.  Federal law requires most drugs to be dispensed by pharmacists, and as such they are, in effect, a public utility and must not be able to impose their own standards on who can or can’t make use of their services.

I can certainly see a case for professional standards being maintained by physicians.  To say “I do not believe in abortion after the first trimester and therefore decline to seek the training to perform procedures to handle later cases” seems completely reasonable.  But, If I Were King, it would most certainly not be acceptable for someone to take a position that required certain work and then to refuse to perform it.

Starting today, Park Nicollet Health Services (Minneapolis, Minnesota) is posting all consulting and speaking arrangements between drug and device manufacturers and the 1400 doctors who work at Methodist Hospital and 25 clinics in the Twin Cities. They aren’t posting this in a huge binder you have to ask for at some hidden counter in the administrative wing of the hospital, or filed with some state office, it’s right at this page on their website.

If I Were King, this level of transparency would be universal. We would be delighted to learn that it was universal because the health-care industry saw the need and did this of their own volition, as Park Nicollet has, but we would issue a royal decree if that were needed.

In the first piece, the Times rightly excoriates the FDA for not adequately collecting and auditing information about the financial relationships between the manufacturers and the physicians that contract to do their testing, based on a report from the DSHS inspector general. One bizarre item was that the inspector general suggested that the FDA gather this information before trials began, which the agency opposed. The Times properly considers this to be backwards, far better to disqualify a contractor based on conflicts before the trial rather than attempt to evaluate a report afterwards when a conflict is revealed — which is probably impossible.

The second article covers a Government Accountability Office report dealing with testing of medical equipment. Apparently, a manufacturer of a pace maker, for example, having been through rigorous testing for one model can bring in the next one and get expedited clearance with very little testing based on the similarity. The story quotes Dr Peter B. Bach of Memorial Sloan-Kettering Cancer Center as saying: “So on the one hand, the manufacturer wheels in their new Ferrari to the FDA and says, ‘Look, it’s a car just like the Model T,’ Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without any necessary actual improvement in outcomes.”

While both articles raise valid questions about how the FDA does it’s job, both miss the point that the FDA is doing a job that shouldn’t be done by government at all. It makes a certain amount of sense for a government agency to run a new drug or device through a series of trials to make sure it is not generally dangerous, but to put a government stamp of approval on a product, endorsing its efficacy in a certain arena, does not. That information can only rarely be derived from limited tests. The most famous case has to be thalidomide, a powerful drug with good results in treating a range of conditions. Unfortunately, it can cause severe birth defects when taken by pregnant women. When widespread use demonstrated that the drug in its original form could not safely be used during pregnancy, a great hue and cry arose and the drug was pulled off the market around the world in 1961.

In 1964 an Israeli physician found that thalidomide was helpful in treating certain complications of leprosy, so the lightning-fast FDA approved its use in that area a third of a century later (1998). In 2006 the FDA approved the drug for use in treatment of multiple myeloma, and the drug is successfully being used in treatments for AIDS, various cancers, certain skin diseases, and macular degeneration. But for thirty years, the benefits of this powerful drug were unavailable to patients.

What we can learn from this is that clinical trials are not a reliable way to identify problems in specific cases, but that intelligent analysis of results in the general population are. We need to have the FDA take a quick look to make sure that a new drug or product isn’t widely dangerous, then get the hell out of the way. We further need to dramatically accelerate the adoption of computerized medical records so that investigators (and by this we mean scientists, not bureaucrats) can more quickly learn the conditions under which a drug should not be used and the relative benefits of different treatments for different situations. The current system tends to suggest that whichever product the FDA most recently approved for a specific condition must be the most efficacious, despite the fact that even the FDA makes no such claims.

If the FDA has a role, the best use of their energies will be to ensure a transparent marketplace in information, so intelligent patients and dedicated health-care professionals will know what analyses were written by doctors who were beholden to the drug companies, and thus make informed decisions. Federal gatekeepers are not the solution, they’re a large part of the problem. If I Were King, the FDA would be much smaller, and dedicated to a beneficial mission that it could perform instead of a dubious mission that it cannot.