Tra il 1944 e il 1974, centinaia iniettati con uranio e plutonio (21 ottobre)

Nota: e dopo? E in Europa?

In science we trust
Date: 21/10/2000

Merrilyn Walton on taking the pain out of medicine

Sixteen centuries since the disciples of Hippocrates wrote the rules governing medical practice, the same rules still say patient interests are paramount. The mantra "do no harm" is as important now as it was then. But in that ancient time, demands on doctors were simpler; there were fewer treatment options and fewer ethical dilemmas. The caution with which those physicians approached their craft was summarised by a laconic Hippocrates in Aphorisms: "Life is short, science is long; opportunity is elusive, experience is dangerous, judgment is difficult." Their rules were straightforward. As long as physicians recognised their limits, did not prescribe deadly drugs, procure abortions or contraception, have sexual relations with patients or the household and kept confidences, they maintained professionalism.

Medicine is synonymous with science. The shift away from the humanities and towards science was kindled about 200 years ago during the age of Enlightenment. Since then, ethics have, for the most part, been a silent travelling companion of medical science.

True there was a flurry of ethical statements after the atrocities by Nazi doctors were disclosed at the 1946 Nuremberg trials. This inspired the creation of the World Medical Association and the Declaration of Geneva in 1948. The Geneva rules, designed to protect the victims of wars, were necessary because the Nazi doctors in Auschwitz had all but abandoned their pledge to do no harm. Their role in legitimising the killing under the guise of medical necessity was a key factor in "normalising" the activities in the death camps. The Declaration of Helsinki, which covers rules governing medical research involving humans, followed in 1964. Apart from these statements and ethical debates clustering around the beginning and end of life, ethics remain a poor cousin of clinical practice.

Yet hundreds of patients continue to receive harmful experimental treatments and their welfare is not always a priority. This year, the United States Office for Human Research Protections stopped five research experiments at the University of Oklahoma because of numerous safety and ethics violations. One experiment involved 94 patients with advanced melanomas who were treated with an untested vaccine made by untrained staff in substandard facilities. Patients were told the experiment might result in smaller tumours, but in fact the experiment was to test the vaccine's toxicity and side effects.

A 1995 report into human radiation experiments in the US in the years 1944 to 1974 documents hundreds of patients injected with plutonium and uranium. One of 21 cases involving children described how intellectually disabled boys were fed oatmeal containing radioactive iron and calcium for breakfast.

Henry Beecher, a whistleblower on unethical clinical research in the 1960s, reported in The New England Journal of Medicine on research being done on vulnerable people, including a study in which intellectually disabled children were deliberately infected with hepatitis.

No country is immune. Most of us associate systematic harm to patients with the past, believing such treatments were quarantined circa 1945 with the end of World War II. But there is sufficient evidence to show that neither time, race nor geography matters. Each time the public hears about patients harmed in the name of research or from their treatments they are outraged. A little more trust is eroded. We just do not accept that patients should be harmed.

Good doctors are struggling to maintain professionalism in a complex web of professional, commercial, government and consumer interests. These relationships are not clearly defined and are constantly changing. Relationships with their patients are the ones under most pressure. Consumers expect doctors to know about the latest developments in drugs and treatments, and to have access to the latest technology. But this can be difficult for doctors having trouble balancing the needs of their patients, in terms of providing appropriate and effective care, with concerns about their income and keeping up to date with the latest information and research.

News about scientific discoveries is delivered with ever-increasing speed, often before testing or adaptation for use on humans. How much this fuels the community's expectations of medicine is unknown, but I am reminded of the first heart-transplant saga, which saw many patients die from this experimental treatment. Thirty-three years ago, when Christiaan Barnard's first heart transplant hit the headlines, many patients believed a cure for their corroded hearts had arrived. Absent from the media was information about the yet-to-be-solved rejection problem. Hopeful candidates were encouraged by the prizes bestowed on Barnard by the media. In that year, most of the 118 patients who had the operation died. By the early '70s, the number having the procedure was reduced to a handful. It took decades of research and testing before the rate of success for heart transplants improved.

Science has enabled medicine to become a powerful profession. But because medical progress has occurred without ethical restraints, there is the danger of becoming de-professionalised. Medicine is a profession because of its scientific knowledge, but also because of its social contract with society one obliging them to use their special knowledge and skills solely for curing and healing the sick.

The underlying principle goes something like this. Patients hand over trust to doctors who, in turn, promise to help them. This promise also entails an understanding that doctors will treat patients by using only those skills and knowledge of benefit to patients. This fulfils the professional part of the contract. When doctors heal or care for patients by applying their knowledge and skills, the medical part of the contract is completed.

Trust is central. Would trust endure if power, reputation or money came first? Trust alone (not reputation, status, the number of publications, or even personality) enables us to hand over responsibility for our wellbeing to doctors. Trust is an ingredient in most human relationships, but in medicine it boils down to patient expectations and professional obligations. Edmund Pellegrino, a renowned American medical philosopher summarises it thus: "We [patients] must trust that our vulnerability will not be exploited for power, profit, prestige or pleasure."

In 1983, the World Medical Association reminded doctors to adhere to the Declaration of Geneva and urged them to make clinical decisions without concern for profit, to be honest with patients and to expose incompetent and immoral colleagues. Where do these ethical obligations fit? Medicine is required to "do good", but it also wears the cloak of science. Ethics have no natural abode in the scientific world. Different values apply. Samuel Coleridge said he "looked into a thing, not to learn whether it could furnish him with food, or shelter, or weapons, or tools, or ornaments, or play-withs, but who sought to know it for the gratification of knowing."

Beside the hard science of the Human Genome Project, ethical rules may seem inconsequential. In my conversations with many clinicians and medical students I am struck by their poor regard for ethics. Many see ethics as "soft", ascribing to science fundamental qualities, and they associate ethics with lightweight qualities. How do we make ethics an equal partner with science?

A beginning is to understand how scientific progress has changed the patient/doctor relationship. This means acknowledging and understanding the unintended consequences the harm to patients.

Take technology, which includes operating theatres and surgical procedures. Add the high-powered drugs used on cancer and cardiac patients, psychotropic medications and anti-microbial drugs and we see how pervasive technology is.

The benefits of mechanical life-support systems are obvious, as are the cancer drugs. Surgical therapies include organ transplant and imaginative diagnostic imaging technologies. But sometimes the skills, knowledge and judgment of the people using the technology are undervalued. These are crucial for maintaining quality care.

Much technology is not properly assessed before use on patients. Robert Teitelman in his book Profits of Science: the American Marriage of Business and Technology explains that for investors in biomedical research the shortest time between the deal and the final product yields the best profits. But premature use on a patient is risky. A small number of doctors are performing procedures on patients inappropriately. I am not including cosmetic surgery here, for which there is a different set of ethical problems. Being proficient at removing gall bladders is meaningless if the patient does not have a problem with his gall bladder.

I also know of patients who have had surgery as their first and only treatment option, not the last. Inadequate medical regulations leave large loopholes for unscrupulous doctors concerned with maximising their incomes.

Keeping up to date is a perennial problem. Knowing when a treatment is outdated is difficult for busy clinicians and harder if they are not engaged in medical education. As Francis Collins, the head of the Human Genome Project of the National Institutes of Health, told The New York Times: "Most physicians in practice have not had a single hour of education in genetics and are going to be severely challenged to pick up this new technology and run with it."

There are few rules in the NSW Medical Practice Act instructing doctors about what they can and cannot do. Doctors routinely use treatments where the benefits are well established, but they are also free to introduce, modify or change treatments in the name of therapeutic innovation. Apart from obtaining a patient's consent, there are no other requirements, such as accreditation or proof of effectiveness or safety. Were genome technology available today, doctors would not be required to know how to apply it, or understand its social implications.

We also need to be aware of the impact of the pharmaceutical multinationals. Their influence extends from sponsorship for continuing medical education to investments worth millions in research and development. Treating patients with drugs remain a vital component of modern medicine. Writing a prescription is the most common treatment, despite strong evidence about the incorrect and uncontrolled prescribing of antibiotics and other drugs. The high volume of drugs in cancer and other diseases also means that patients are encouraged to participate in drug trials. Whether this is a good thing for patients in the end stage of their lives is a consideration often sacrificed in the name of medical progress.

Targeting doctors and applying market pressure has made pharmaceutical companies among the most profitable companies. Once they were content to market their drugs to doctors. Now they co-opt them into research. Practitioners and institutions in most developed countries are paid substantial fees for enrolling their patients in drug trials. Tom Bodenheimer this year reported in The New England Journal of Medicine that in 1991 80 per cent of industry money for clinical trials in the US went to academic medical centres; by 1998 the figure had dropped to 40 per cent.

Unlike career medical researchers, many private practitioners do not know how to conduct research. They are also susceptible to company-generated influences looking for favourable results. But of most concern is the lack of understanding many doctors have about informed consent for experimental treatments.

The US inquiry into human radiation experiments reported that a recommendation by a doctor to participate in research was interpreted by many as an endorsement of the research project. Patients believed their doctors would not be dishonest or recommend anything potentially harmful.

Research about treatments is rarely reported from the patient's perspective. Their experiences of pain and suffering, lifestyle adjustments and loss of dignity are not considered important enough to include in research trials. Information about patient deaths, morbidity and future quality of life are not routinely taken into account when evaluating technology. Qualitative research about the experience of patients is rarely funded, because medicine has been seduced by the randomised control trial.

The ethical issues raised by the Human Genome Project are not about the technology itself, but about its proper use. That medicine applies new scientific knowledge for patient benefit is not the issue; the difficulty is how it applies it. How to marry the science with the best interests of patients? How to marry the many interests involved? The biologists are keen to locate the DNA markers along the chromosomes, while the medical scientists are anxious to identify the genes involved in diseases. The consumers want to know who owns their genetic profile, who can access it, and under what circumstances. Already we have examples of genetic discrimination by employers and banks.

The inclusion of medical ethics in medical curricula is recent. If the goal of medical education is to create "good doctors" we should be teaching ethics continuously at the bedside. Ideally, the clinician teaching about disease should also be teaching about medicine's moral, societal and professional obligations. The goal is to turn out doctors who can competently analyse clinical situations, identify moral, ethical, societal and legal issues, and apply this knowledge sensitively, taking into account the patient's circumstances.

Recently at a medico-legal dinner, a judge said to me that he was concerned medical progress would slow if burdensome rules or public pressure caused fewer patients to be included in clinical trials or experiments. He was concerned with results. His views reside comfortably with the consequentialists who conceive moral life in terms of means-to-an-end reasoning. The greatest good for the greatest number is the value espoused. But for me, I do not believe that patients should be harmed in experimental treatments even when there is the chance of better treatments for future generations of patients. Nor am I prepared to say that no patients should be used in research.

The technological age is still young. Cloning, gene manipulation and DNA research are all in their infancy. The human genome is revolutionising medicine as we speak, but where will it leave patients?

Today, the grand themes of science are not uppermost in all our minds. More prosaic values such as compassion and quality of life have our attention. But these are the values undervalued in medicine. A passion for ethics is required. Combining basic skills of communication and information-sharing with the best interests of the patient may be the clinical catalyst for reconnecting medicine with ethics. The human genetic blueprint will test medicine. How we manage this will determine where medicine sits in our hearts and minds.

Merrilyn Walton is associate professor of ethical practice in the Faculty of Medicine at Sydney University and the author of Trouble with Medicine: Preserving the trust between patients and doctors (Allen & Unwin).