Restricting Drug Access

Dr. Scott Gottlieb’s title of his op-ed column in The Wall Street Journal, “Congress Wants to Restrict Drug Access,” is misleading, not by what it says, but by what it doesn’t say.

Dr. Gottlieb does talk about how research on effectiveness of drugs will lead to restriction on what drugs a patient may get, and this means those patients who want a more expensive drug will be unable to get it. As Dr. Gottlieb mentions, we already have this kind of restriction with Medicare Part D.  What he doesn’t say is that we already have this restriction from insurance companies. Insurance companies will often only pay for generics.  Even if the generics don’t work.

What Dr. Gottlieb fails to address is that the problem is really an issue of how research cannot actually measure what is effective treatment for many individuals. Research can show that generic drugs may work for many people, but research does not take into account the outliers—the individual instances which don’t fall within the desired results. Research studies throw the exceptions to their end result out before they run the mathematical formulas to give that magical “statistical significance” calculation.

S. Paul Posner noted this problem as well in his letter to the editor, “Everyone’s for Effective Treatment, but What is That.” As he writes, “there are serious issues as to how to measure cost effectiveness….” Steven Goldman and Michael Russo add further caveats to the headlong rush to clamp down costs with “cost-effective” care.

The only medical person who can determine what medical care is appropriate and cost effective is the treating physician, the physician who actually sees and treats the patient, in conference with the patient. The result of treatment decisions being made on the basis of “cost-effectiveness” by Medicare Part D or an insurance company is oftentimes the cheapest, and let’s get this right out on the table, oftentimes ineffective care for many people. We already have misguided “cost-effective” gatekeepers in place.  Dr. Gottlieb’s venerable scientific research isn’t going to change this situation.

Nor is reliance upon physician’s medical groups to come up with the rules.  Physicians know about guidelines for care promoted by their professional organizations.  They understand them as guidelines, not rules.  But Medicare, Medicaid, and the insurance companies use the guidelines are rules, and become gatekeepers of cheap, often ineffective care.

I have no problem with studying how some treatments may provide similar results at less cost, but applying strict scientific research methods, as suggested by Dr. Gottlieb, in no way will provide reliable treatment modalities for a large part of the population because quite simply, only the treating physician and the patient really know what works in a given situation.

The treating physician and the patient must be free to try to adjust care to fit the situation, not be told what they may or may not do by a gatekeeper determined to allow only the cheapest care possible. Such gatekeeping is no different than providing no care at all.

dhaugen
Some young HR person once looked at my CV and asked me, quite seriously, if I had really done everything I had listed there. Well, yes. Because I am someone who can't sit in a Morris Miller cubicle every day, much less for any great stretch of time. Once the problem is solved, I get bored and I'm ready to move on to the next challenge. This hasn't afforded me any great stability in my work life. I simply arrive in places about ten years ahead of time. So far, at least, that penchant for early arrival hasn't been accompanied with a pocketbook full of door knobs.
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