Post-marketing Surveillance

The Zyprexa story, reminiscent of Vioxx. This is starting to become a pattern: drug maker gets sued over adverse affects that it downplayed during the FDA approval process. Often times the adverse affects - in this case the onset of diabetes after taking the anti-schizophrenic drug for some years - don't show up immediately.

The pharma industry, I hope, is learning the hard way that it needs to be transparent about pre-market data. There is no sense in covering up a potential adverse affect or promoting an off-label use (which is illegal anyway) when there will most certainly be a billion dollar lawsuit down the line. The FDA has undergone a considerable amount of criticism recently for its lax regulatory control, and in the past I presume that manufacturers whose drugs had been approved by the FDA had better protection from lawsuits. But all that is starting to change.

On the one hand I am glad that there are vigilantes among the medical malpractice, public health and communities. Big pharma's primary motivation is to make money, not cure disease. Moreover, the FDA is underfunded and understaffed. And lastly drug adverse affects may not show up until some years of use, or, they may be uncommon enough that they do not show up in the pre-market clinical trials that are usually based on hundreds-to-thousands not millions of patients. For these three reasons, post-market surveillance is absolutely critical to patient safety (which is not to say that drug makers or the government should be funding massive clinical trials for years before a drug is approved - that's impractical and financially unfeasible).

On the other hand, the medical community needs to make sound decisions that are in concordance with each individual patient's goals and desires - in the Zyprexa case, a doc should not be prescribing the medication to someone who may be at risk for developing diabetes - unless this risk is pretty small and the patient is fully aware of that risk in light of the potential benefits of the drug.

I'd like to fire these patients, now please

I've upset 2 patients so far here in Burns, both last week and both for the same reason. One was morbidly obese, the other had very poorly controlled type 1 diabetes. Both refused to concede that their health problems (back and joint pain, shortness of breath in the obese woman; gastritis in the diabetic) were caused by their underlying co-morbid conditions, and they were both irritated that I told them they were.


So what do you do with such people as a physician, having taken that special oath to do whatever was in one's power to promote the health and wellbeing of one's patients? If I were a car mechanic I would simply say, "fine, Dave down the street may be willing to help you out instead."


Certainly, doctors "fire" patients, but this is typically for an ethical or personal issue that is irreconciliable and stands in the way of providing optimal health care. But in this case these patients were just being stubborn, not to mention foolish. And actually there was a third patient who insisted he get antibiotics for chronic sinusitis. It was not indicated in his case and he threw a hissy fit, insulting my attending, in the exam room (he was an unstable patient who had self-control issues, clearly). Actually I thought he might get belligerent. Most doctors would love to "fire" patients like these. Their personalities are toxic. They are hurting themselves and you are powerless to do anything. These are frustrating patients because there is no - or very little - hope that they will get better.

American society is a society that values freedom but not equality, although it often conflates the two, and does so perhaps out of privileged-class guilt.

Speak sense into the public, ye doctors

I am in Burns, Oregon on my rural family medicine rotation right now. I was talking with my attending today about how the decline in the medical profession is in part the fault of doctors who for whatever reason remain disengaged from the political infrastructure that has come to shape their profession. Doctors on the whole, though, just don't have time to take a role in activism. I think the public suffers too, as the outrageously irrational anti-vaccination trend illustrates. Doctors need to support public campaigns that disseminate scientifically sound evidence and the sound medical practices it supports. Vaccinations do not cause autism. The overall risk of acquiring a disastrous infection is greater than the risk of an adverse reaction BY A LONG SHOT.


http://www.medscape.com/viewarticle/571496?src=mp&spon=17&uac=

Medical Excess

An essay in the NYTimes today on doctor excess - how we order too many tests and do too many procedures - a capitalist response to the free-market squeeze of declining reimbursement (physician reimbursement is based on the fee schedule that the federal government sets regarding medicare/medicaid).

What the author, a doctor, does not mention however, is that some of this excess medical service is driven by what we call "cover-your-ass medicine": medical decision making that is driven more by the fear, which is substantiated, of future litigation than by science, evidence, ethics, or sound economic judgment.

Another important factor that plays into excess is the desire of patients to have gilded medical care. Americans have an attitude of entitlement when it comes to medicine - we feel that we deserve nothing less than the best modern medicine has to offer - whatever the cost. This is an immeasurably detrimental attitude because it leads to insane medical practices like spending 200K to keep a dying many alive for a 2 weeks in the hospital when that same money would be more rationally used as a wide-ranging distributive investment in the health of a hundred children.

A third factor is the very poor use of evidence-based medicine to establish practice guidelines for tests and procedures. If there is no indication (reason) for a test or procedure that is based on epidemiological evidence showing improved health outcomes, then it should be the patient's responsibility to pony up the money for the test/procedure if they want it, not the government's or insurance company's. I know there would be a lot of political fighting over those guidelines (insurers will want to save money, doctors will want to ensure they have enough freedom to treat their patients as they see necessary independently of economic considerations), but that is really the only way to reign in excess and still protect doctors legally.

Yayoi Kusama (artist)