Saturday, February 16, 2008

The N = 1 Trial

[Clink Note: First I put up this post, then Dinah posted over it, then she reposted it at the top of the blog with bookend comments. I've taken out her bookend comments and put them immediately after this post, so please do scroll down to read them or click here. Oy. My Comcast access has been really spotty or non-existant this week so I have to act fast while it's up.]

In the January edition of American Psychiatry News Dr. Glenn Treisman writes a critique of the "fail-first" policies of managed care organizations entitled Promoting The Concept Of The Individual Trial (free registration required to read the article). He begins with a brief case presentation of a patient who was successfully treated as an inpatient with a drug that was nonformulary according to his new insurance company. The patient was discharged and his outpatient doctor, who didn't have access to his previous treatment records, switched him to a different formulary medication which he had previously failed. The patient relapsed and required rehospitalization.

He begins with a critique of the idea of therapeutic equivalence. Therapeutic equivalence refers to the idea that different medications can be shown to be equally effective in treating a given medical condition. Dr. Treisman rightly points out that this evidence is based on treatment response of large groups of patients and may not be predictive for a given individual. For example, SSRI's as a whole may be equally effective in treating depression but a specific patient may find Zoloft more effective than Paxil. There may also be specific individual issues such as co-existing medical conditions that may influence a clinician's choice of medication. (See also Dinah and Roy's posts on How To Choose An Antidepressant, Part 1 and Part 2).

He goes on to attack what he refers to as a perversion of the term "evidence-based medicine". This term originally meant that doctors should base their treatment decisions upon current research, using the best information that is available at the time. He alleges that insurance companies use evidence-based practices as an excuse to deny care and save money:

"At times, evidence-based medicine has come to be used as an excuse to change the equation of medical treatment entirely. The new equation is to start with the premise that treatment should not be used unless it has been 'proven' to work."
The misuse of therapeutic equivalence and evidence-based medicine, according to Treisman, has caused patients to become disillusioned and suspicious of traditional medical care and turn to alternative and homeopathic treatments. And for doctors he feels the nonformulary approval process "wastes the time of busy physicians" and injures patients.

So that's my recap of the article. My reaction to the article is that I agree wholeheartedly with Dr. Treisman that it's good to remember the limitations of large clinical trials when you're treating the individual patient. It's also good to remember that therapeutic equivalence is a regulatory concept not necessarily a clinical truth.

Here's where I disagree:

The nonformulary process and the emphasis upon adherence to treatment guidelines is not solely the fault of the "evil" greedy insurance companies. I think we as physicians need to accept our role in driving these policies.

Health care cost containment is everyone's responsibility. It's easy for doctors to feel bothered by paperwork, to feel threatened by challenges to clinical autonomy, or to be offended by suggestions that one's practice is not up to modern clinical standards. But the fact of the matter is that in psychiatry there are a lot of free-wheeling physicians out there. Indiscriminate use of expensive medications for vague clinical indications (Seroquel for anxiety, anyone?) drives up the cost of health care for everyone. And practice guidelines were not developed by insurance companies. They were created by professional organizations to enhance the overall standard of care and quality of care given by their physician members. The professionals themselves recognized that there were issues with wide variation in patient care, or suboptimal care, long before insurance companies got ahold of these guidelines.

It's a facile sleight-of-hand trick to point to the evil greedy insurance companies for the policies that now nag us. I'd remind folks that we have only ourselves to blame.