Once again, the influenza vaccination has proved to be a conundrum.
In 2003, the demand for the vaccination exceeded the supply available. The public fear approached hysteria, as there were reports of deaths of children in Colorado. The news media fanned the flame of worry as nary a day went by without a report of the projected ramifications of the shortage of influenza vaccine. The Centers for Disease Control and Prevention (CDC) struggled with establishing recommendations for vaccination of high-risk individuals.
In 2004, the demand for influenza vaccination again exceeded the supply. Thankfully, however, we have learned from our past errors. The CDC was extraordinarily prompt in establishing and publishing vaccination guidelines for the current shortage. The news media also appeared more circumspect in reporting the vaccine shortage. There appeared to be a concerted effort to publish accurate and adequate medical information.
Questions abound. How is it that a vaccination shortage of this magnitude can occur in two consecutive years in a country with arguably the best health care in the world? In 2003, the supply (which had been more than adequate for prior years) was inadequate because of unexpected demand. In 2004, the supply was limited due to contamination of the product during the production phase.
Severe rationing of the vaccine was proposed, and—for the most part—only the very young and the very old were eligible for vaccination. So how did Western New York deal with the crisis? Many vaccination clinics that had been scheduled were canceled. Those that took place as scheduled suffered unique problems. The waiting line of patients was several hours long, and several patients fainted while in line. Some of the locations administering vaccinations did not strictly adhere to the guidelines established by the CDC. More than a few Buffalonians crossed the international border and were vaccinated in Canada (where the CDC guidelines were ignored).
Even now, the Medical Society of Erie County is involved in an extraordinary rare medical occurrence. Under the auspices of the CDC, doctors in Erie County are notifying the Medical Society if they have extra vaccination product. The purpose is to redistribute influenza vaccine from a medical practice that may have more than it needs to other practices that might be in need of vaccine to distribute under the CDC guidelines.
With an eye to the future, the CDC has announced the creation of a permanent panel of ethicists whose charge is to make recommendations regarding the current crisis as well as any future epidemics. This ethical issue is known as the allocation and distribution of medical resources. In actuality, it happens often in all types of medical practices. Who gets a certain medication? Who will benefit most from a certain type of surgery? The distribution issue involves three basic notions: 1) who receives, 2) who decides, and 3) how does the decider decide? As well-intentioned as this panel of ethicists may be, there are basic concerns that are inherent to the process.
Perhaps the best example of this problem is provided by a look at a panel of experts that—some years ago—was charged with the decision regarding the allocation and distribution of the first kidney dialysis machine. This panel struggled with the decisions as the members considered multiple issues, including age, health status, risk-benefit, finances, potential benefit to society, future patient compliance, and others.
In the end, the panel was unable to decide; the ethical pressures were simply too great to make the decision. Yet a decision had to be made, and it was made. How? The choice was made by lottery. At first glance, lottery may appear to be a fair method. But even a lottery discriminates against those who are not in the lottery. So, in a world with limited resources, the question remains: who decides, and how?
But let us not totally dismiss our ingenuity. There are still several options that medical legal experts can employ to avert future crises. The influenza vaccination has unique medical problems. It is limited in that a given year's supply can only be used for about six months. In addition, each year's product is based on projected trends of viral change at the international level, and the product must be remade each year.
If the medical and legal authorities feel that the concept of vaccination for the majority of our country's population is appropriate, then certain changes must be made. The first involves the system of financial reimbursement. If it is deemed necessary that vaccination be provided at the national level, then the cost of vaccination must be subsidized at the national level. A pharmaceutical company operating under these parameters should not be expected to suffer financial loss in the production of the material.
The other change must be at the legal level. As medical liability lawsuits were part of the reason for the dissolution of American companies formerly making vaccination product, then tort reform is necessary. New York State has a vaccine reporting system in place that—for the most part—prohibits individual lawsuits dealing with individual vaccinations, yet at the same time allows a set monetary award from an established pool of monies. I suggest that the influenza vaccination product be allowed access to this plan.
We, as a society, have difficult medical-ethical choices in our future. Allocation and distribution of influenza vaccination is but one of these many ethical health issues. Let us guide ourselves more by justice and beneficence rather than personal autonomy and nonmalfeasance.