If I Were King

A pair of recent articles regarding the performance of the Food and Drug Administration recently came to our attention. The first was a New York Times editorial titled Not What We Call Due Diligence, berating the agency for the way conflicts of interest were identified and dealt with in the approval of medical devices. The second, also from the New York Times, was an article out of Washington City titled Report Criticizes F.D.A. on Device Testing, relating to devices getting approved too easily in testing.

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.

The Supreme Court ruling in Herring v. United States last Wednesday (14 Jan 2009) foolishly limited the evidence exclusion rules regarding police actions. Chief Justice John Roberts wrote the majority opinion, including this: “To trigger the exclusionary rule, police conduct must be sufficiently deliberate that exclusion can meaningfully deter it, and sufficiently culpable that such deterrence is worth the price paid by the justice system.” This is utter nonsense.

Police departments and individual officers are motivated to do their jobs well, and both bitterly resent it when a case they feel they’ve made is tossed out “on a technicality”. Part of me immediately says, “tough!”, but part of me says, “good!”. It is best if cops do their jobs effectively and proudly, any employee or organization will do their best when they feel like they are performing well and their work is respected. Their motivation to eliminate wasted efforts can be powerful, and should be encouraged.

Roberts asserts that the occasional sloppy police work will not be deterred by throwing cases like this out of court, which means he has absolutely no sense at all. Occasional sloppy work is not something that just occasionally happens. Sloppy work is done in environments where sloppy work is acceptable. If sloppy work means your fellow officers are going to be upset about losing these cases, those officers are going to be powerful advocates for eliminating slipshod record keeping (as in this case) and other systemic failures.

If I Were King, I’d take advantage of this. Make sure the cops are trained well and have the resources to do their jobs. Don’t ask them to do idiotic things like fighting the War on Some Drugs. Back them to the hilt when they’re doing their jobs well. But never let them reap the rewards, either in advancement or satisfaction, of being casual about their responsibilities.