A recent Wall Street Journal shows how hard it is to get incentives right.
Blue Care Network, an HMO owned by BCBS of Michigan, paid primary care physicians $100 for every patient switched from two branded statins (Lipitor and Lescol) to generic Simvistatin. The rationale for the effort was to save money for the insurer (in drug costs) and the insurees (in reduced copayments). The rationale for the $100 payment to physicians was that (a) deciding whether the switch was OK for a particular patient, (b) explaining the recommendation, and (c) answering questions, (d) takes time, for which (e) they should be paid.
The rationale for rewarding the physicians is correct. High quality cost effective practice takes time. If physicians aren't paid for the effort their compensation/time drops. They are penalized for doing the right thing.
The rationale for helping BCBS achieve savings is also correct. BCBS of Michigan is a not for profit company with a 70 year history in the state. Physicians encouraging generics don't have to wonder if the savings go to hedge fund investors. They can be reasonably confident that savings benefit enrollees, not day traders.
Despite the good reasons in favor of the incentives, the system, which was time limited, was a mistake.
The AMA correctly notes that the incentives look too much like kickbacks to pass the smell test, especially if the patient is not aware of the payments. Unfortunately the AMA's otherwise educative discussion perpetuates our national muddle-headedness about the ethics of considering costs:
“Physicians should prescribe drugs, devices, and other treatments based solely upon medical considerations and patient need and reasonable expectations of the effectiveness of the drug, device or other treatment for the particular patient.” (emphasis added)
An ethical health care system should ask its physicians to care about costs. Societies need physicians to consider the denominator(insured populations) as well as the numerator (individual patients). Patients aren't harmed by choosing the branded product over a qualified generic, but society is.
The US is a test case for what happens when we ignore communitarian ethics - uneven care, 47 million uninsured, and runaway costs. As I argued ten years ago in the BMJ ("Fairness as a Problem of Love and the Heart: A Clinician's Perspective on Priority Setting"), we can only ask physicians to take a communitarian perspective in organizational settings in which physicians and their patients can be confident that savings advance the health of the involved population.
Michigan BCBS is such a setting. The aim of the incentive program was correct, but the incentive was structured wrongly. Less direct incentives, like increasing reimbursement for office visits to physicians who practice high quality, cost-effective medicine, is the way to go.
Is the FDA Failing It’s Sole Objective, You and Me?
ReplyDeleteThe Food and Drug Administration originated in its primitive form at the time several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, amounts so large that are issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income. Results of this relationship, one could posit, have been the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit, as these unfortunate events have occurred quite often.
And the intimacy between the two organizations seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way, claiming that this would enhance the education and knowledge of the prescriber.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The pharma companies that allowed such criminal offenses, through vicarious liability at times, perhaps, never admit guilt as part of such settlements.
This FDA protocol that is now being considered, called, “Good Reprint Practices”, would require reps to use what does not truly exist likely, which is truthful and authentic clinical trials when they do speak off-label to prescribers, if this becomes allowed. This in itself lacks etiology for such discussions by reps, as many clinical trials may be flawed due to the trials being possibly manufactured by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability to analyze data regarding this issue accurately is unlikely, for the most part, I surmise. Remember that most pharma reps have no medical or clinical training in any objective way, and, in my experience, have no interest is such training. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices with deliberate intent and reckless disregard for public health, so it seems. Yet this situation appears to be of most benefit for drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens do not to be the focus of this administration.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Because historically medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit.. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves. And the health of the public is that interest.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung
Dan Abshear