DO NO HARM
The ethical problems encountered in public health span the spectrum of those seen in clinical medicine, but they have additional ramifications. The oft-repeated admonition First Do No Harm, heard throughout the years of medical training, usually referred to errors of commission. Even when the Institute of Medicine published a book on medical mistakes, it concentrated on such errors (1).
But when Wolf Bulle told me, as I left for Africa in 1965, “You will never forget the people you kill,” it caused me to wrestle with that concept.
Errors of Omission
It soon became clear that we will, of course, not know most of the people we kill. Far more people die and suffer because of our errors of omission. The science not used, the science not shared, the vaccines not given, and the prevention not practiced, the Medicaid not expanded, the millions without health insurance, all cause harm but are rarely mentioned or even recognized in the context of First Do No Harm. Because the price of those omissions is usually not seen, it is often discounted.
Medical care today makes it difficult for the busy practitioner to discuss prevention with patients. Most insurance plans do not adequately compensate practitioners for time spent giving prevention advice. A half-century ago, people were worried about socialized medicine without understanding that capitalism would soon take over medical care in the United States. Now profit drives the system, and because of that, it is possible to violate the First Do No Harm dictate repeatedly each day. It is as if we were told in school to do no harm unless money is involved.
We stand embarrassed to spend more per capita on health care than any other country; yet, we cannot match the health outcomes of the top twenty countries around the world. We proudly promote the marketplace as the way to deliver health care without acknowledging that the vast majority of those countries have single-payer systems. Are we interested in promoting the marketplace or promoting health? And isn’t the burden on us to show that the marketplace can do better rather than continuing to just say it?
The way out of this ethical dilemma is to have a single-payer system in which all are treated equally and health results become the standard for measurement. At present, the marketplace pays for process rather than outcome, and prevention is not a billable commodity. In the single-payer system, payments could highlight results in terms of morbidity and mortality. Results cannot always be measured for individual patients, but aggregate results can point out which programs should receive financial rewards.
This problem is not limited to medicine. The people for whom we vote make decisions on food stamps, medical coverage, education support, and research appropriations. When they vote not to provide early education, medical care, prevention, or Medicaid expansion, we as voters kill through errors of omission.
In addition, it is a false argument to say that it is either the marketplace or socialized medicine. Our military is superb. It is based on a single-payer system, but it is then expected to use the marketplace to acquire the commodities and systems required. Medical care could use the same approach. Somehow, the opponents of a single-payer system seem to imply that advocates are unpatriotic. The same argument is not made about advocating a single-payer system for the military.
And so public health must continuously be concerned with the harm resulting from actions taken, but especially it needs to be concerned with actions not taken. The dictum of First Do No Harm brings the ethical battlefield to budgetary medical ethics (2).
Ethical concerns are nothing new to public health.
In 1976, The Last Chance Diet was published, and liquid protein diets became a popular way to lose weight (3). By August 1977, the FDA and the CDC had both received reports of women dying while using such a diet. In general, the reports were always of women, and they were usually young, in their thirties.
To provide context, what was happening in the other news at that time? A month earlier, the first oil flowed through the Alaska pipeline to Valdez. A week after the oil flow, President Carter created the Department of Energy. On August 16, Elvis Presley died at Graceland at age 42, and the Apple II computer went on sale. It was in the midst of this, that young women were dying as the result of a diet. EIS officers were dispatched. Together with the FDA, they studied more than thirty cases of sudden death. Since many of the deaths were in California, Rep. Henry Waxman (D-CA) held a hearing on December 28, 1977, in Los Angeles. He requested that I testify, together with the FDA, on the findings.
Semistarvation diets in previously obese persons warrant special attention to conduction problems of the heart. The consensus of those involved in this investigation was that somehow these deaths were indeed caused by cardiac conduction defects. The diets were quickly pulled from the market, but then a new and unexpected problem concerned the CDC. Senator Charles Percy, in his second term as a senator from Illinois, asked, through his staff, for the names of the women who had died. He wanted his Senate committee to conduct an investigation of the deaths to verify our results.
This was unprecedented for me, but I understood the logic of having an independent assessment. My concern was that the CDC investigators had provided assurances to the families that their information would be considered confidential. How could we furnish those names to a member of Congress?
My initial response to the Senate committee was to suggest that the CDC could provide the names to a separate nonpolitical medical group, such as the National Institutes of Health, for it to do an independent investigation. The Senate staff turned down this suggestion.
I then learned from the CDC legal counsel that I had no choice but to provide the names for two legal reasons. First, people lose their privacy at the time of death, so that privacy cannot be the reason for withholding names. Second, Congress has exempted itself from the Privacy Act; therefore, it can request and must receive information we would ordinarily consider private.
It was a disturbing position to be in. When I realized that I had no legal option, I called the Percy staff and asked whether they would be willing to issue a subpoena for the information. They said, “Of course.” I had not expected them to immediately ask, “And then you will provide us with the names?” I said no, I would not, but we would then go to court, and the court would require that I give them the names. “If you already know the outcome,” they asked, “why would you make the extra work for everyone?” I said it was because I wanted people to know that I had done my best to protect their privacy and that legally there was no more that I could do.
The interesting result was that they dropped their request rather than confront what might be adverse publicity for them. But this incident left me disturbed because the legal and ethical responses seemed to differ.
Hospital Infections
There were other dilemmas in the CDC’s daily routines. Our laws are not always the best way to achieve health protection. On one occasion, an unusual organism was cultured from a person who had a new heart valve that had replaced a diseased valve. The hospital did the correct thing and called on the CDC to help trace the source of the infection. The unexpected finding was that this was not an infection caused by a break in the hospital’s infection-prevention program. The infection was traced back to the valve manufacturer. In many ways, this is more serious because other hospitals would also be ordering valves from this supplier.
The case was reported in the MMWR to quickly alert the medical establishment. The hospital with the original infection was identified only as Hospital A in the report. After the report was published, a lawyer quickly filed a request for the hospital’s name under the Freedom of Information Act. The lawyer then offered services to the patient, and they brought a $1 million lawsuit against the hospital. In a logical world, the hospital should not be held responsible for the contamination of the valve at the site where it was manufactured. Nonetheless, the hospital was faced with a lawsuit and, a model of cooperation to that point, it told the CDC it would never again report a hospital infection. The public did not win with that decision.
There are frequent calls for publication of infection rates by hospital, with the belief that patients are protected if they have this information and can then make the decision to avoid hospitals with high rates. Transparency should be the rule. But the public should also be warned that frequently the highest rates of reported infections are in hospitals with the best programs; their rates are high because they have a functioning surveillance system. They actually seek and publish the results of their aggressive approach to reducing infections. Therefore, the risks may, in fact, be much higher in a hospital that reports a lower rate but has an inferior surveillance program.
Rates are also frequently higher in hospitals that care for many people who lack health insurance and who may enter the hospital in poorer physical condition than patients with good insurance coverage. A similar dilemma is seen in the reporting of hospital mortality rates; some of the best hospitals are faced with some of the most difficult cases. Such hospitals get these referrals because of their extensive experience and because they are often the hospital of last resort for some conditions.
Liquid protein diets and infected heart valves are the tip of the ethical dilemmas faced in public health. When we require immunizations for school entry, how do we compensate the small numbers who suffer adverse consequences from following the public health recommendations? In clinical medicine, reactions to penicillin or other drugs are accepted because those drugs are taken to treat an immediate threat, an infection. The risk-benefit discussion weighs taking the antibiotic versus the risk of not treating the infection.
The risks of Sabin polio vaccine were small but real. The risk of polio disease was even smaller but would increase if immunization rates fell. This difficulty finally led to a return to Salk inactivated vaccine in this country because it had no risk of disease associated with it. But the problem exists for other vaccines. What are the ethical obligations when we urge people to take the small risk of a vaccine side effect for the benefit of society?
What are the ethical implications of prescribing antibiotics for viral infections? Or of stopping a course of antibiotics when one feels better, even before the infection is adequately treated, thus giving the organism a chance to develop resistance? What are the implications of using antibiotics to speed the growth of animals, even if that also increases the risk of organisms’ developing resistance?
Much of the increased life expectancy in the United States in the past century is due to prevention, vaccines, safer water supplies, food safety, reduced smoking rates, exercise, highway safety, sunblock, and millions of daily prevention decisions. How should we measure the harm caused when public health appropriations are inadequate?