Friday, April 15, 2005

Separation of Clinic and State?

The separation of Church and State is mandated by the federal Constitution.  Would it also make sense to require a separation between politics and medial practice?  Probably not.  Religion does not have the same potential to be lethal when used improperly (unless you count war and all those other nasty things people do using religious fervor or righteousness as a false pretense.)

Then sometimes you run across things like this:
A federal judge in Utah today struck down the federal government's ban on the dietary supplement ephedra, which was pulled from the market last year after it was linked to more than 100 deaths.

The judge, Tena Campbell of the United States District Court in Salt Lake City, said that ephedra was a dietary supplement and that under rules of the Food and Drug Administration it was the government's burden to prove whether the supplement was harmful if taken in dosages recommended by the manufacturer. In this case, the judge said, the government had failed to do so.
...and you wish Government would just get out of the medical business altogether.  I don't know about the legal merit of her argument, but from a medical standpoint, the decision is almost a parody of libertarian principles.  It seems obvious that you need something like the FDA to impose regulation on a product that is so dangerous, with no valid redeeming qualities.  But what one branch of government can take away, apparently another branch can restore. 

If the ephedra case does have merit, then the FDA regulations should be changed.  I've long thought that they are too loose in the area of "dietary supplements," anyway.  Some of those products have enough pharmacological activity that they should be regulated as stringently as pharmaceuticals.  Clearly, the FDA should be able to designate some herbal products as drugs instead of foods, thereby enabling regulation using the more stringent guidelines.

Closer to home, and illustrating another wrinkle in the governmental role in the regulation of medical practice, is this story from The Pleiad, Albion College's student newspaper:
They want it now
Protests stem from doctor’s comments
April 8, 2005
Carolyn Widman
Senior Writer

Shouts of “What do we want? EC! When do we want it? Now!” echoed across the quad on Wednesday morning, March 31. Students working on bringing emergency contraception to campus gathered outside the Student Health Services building at 8 a.m. to protest the decision to not dispense or prescribe emergency contraception, such as Plan B.

Ken Powell, Midland senior, has been collecting signatures for a petition to bring emergency contraception to the Health Center since February. He and Ryan Sebolt, Lansing senior, organized the demonstration.

Throughout the past three weeks, Powell and co-presidents of POWER Lauren Duthie, Dearborn sophomore, and Amanda Boundy, Eben Junction sophomore, have been in meetings with Sally Walker, vice president of Student Affairs and dean of Students, Cindy Magness, RN, director of the Health Center, and Dr. Martin Holmes, the Health Center’s medical director.

Legally, Holmes is responsible for deciding what gets prescribed to students. He has stated that his reasons for not allowing emergency contraception at the Health Center are based on both medical and personal beliefs.
I actually know Dr. Holmes, and I respect him, and I want to agree with him, although in this particular case I do not.  Even though I disagree with his decision, I can't come up with a good argument for a governmental regulation that would compel him to prescribe emergency contraception.

On the other hand, there is this recent development (from Medscape - free registration required):
U.S. Bill Would Enforce Contraceptive Access in Pharmacies
Todd Zwillich

April 14, 2005 — Washington lawmakers introduced a bill Thursday making it illegal for pharmacies to refuse to fill prescriptions for birth control, fueling a growing controversy over whether pharmacists have the right to withhold oral contraceptives from patients with valid prescriptions.

Under the "Access to Legal Pharmaceuticals Act," introduced by Democrats in the House and Senate, pharmacists who refuse to fill any prescription because of "personal beliefs" must ensure that another dispenses the drugs. Pharmacies that do not stock a drug must order it immediately at the patient's request, it states.

[...] While the bill applies to all prescriptions and does not specifically mention contraception, supporters made it clear that it was intended to head off a growing number of pharmacists who are refusing to fill prescriptions for birth control and emergency contraceptives because of moral objections. [...]
This is superficially similar -- but fundamentally quite different -- than the case above, in which a physician refuses to prescribe emergency contraception.  There are times that pregnancy is medically hazardous, so that emergency contraception could be a lifesaving intervention.  While the physician is in a position to know whether a given patient is in this category, the pharmacist is not.  It is difficult to image a moral framework that would justify withholding a lifesaving medication under any circumstances, except for those that believe that all medical intervention is wrong. 

Clearly, there are no pharmacists who believe that all medical intervention is wrong, so that exception is a moot point.

Now, in actual practice, I don't know if the Access to Legal Pharmaceuticals Act would be effective in all circumstances.  Emergency contraception has to be taken within 72 hours of unprotected coitus to be reliable.  Compelling the pharmacy to order the medication would not assure that it would arrive in time.

Even if the legislation does not always produce the desired outcome, it would have an interesting effect upon the pharmaceutical profession.  Those pharmacists who insist on sticking to their principles would have to know that they might not always be able to do so, legally.  They then would have to decide if they believe in their principles so strongly that they will risk prosecution, or change to a different profession. 

Obviously, the big corporate pharmacies will not want to risk the heavy fines called for in the legislation, and will keep the product in stock. 

I guess I can't make an argument that there should be complete separation of clinic and state, even though it sounds attractive sometimes.