The first written code for physicians

There are four pillars of Physician Ethics – and it is from these that modern physicians make decisions. It is from these we judge ourselves, and – if called upon, our colleagues. Those Four Pillars are autonomy, nonmaleficence, beneficence, and justice.

Dr. Burzynski is a physician who runs a cancer clinic in Houston that specializes his own invention of cancer therapy called antineoplastons. He has been in the news lately because one of his supports has threatened a 17 year old blogger in Great Brittan with legal action. There is plenty of discussion in the blog world about Dr. Burzynski’s therapy- and I wrote a short piece about this in another blog- but was asked to discuss this from the ethical perspective of a physician.

Autonomy
As a physician we have ethical obligations, and expectations to our patients. One of them being autonomy – people are truly free to choose their treatment, but must have the information that is required to make a choice. More about innovation and research in a bit, but there are plenty of cancer patients who willingly submit themselves to treatment that has no proven benefit beyond a lab.

Nonmaleficence
Another key tenet for physicians is nonmaleficence – to not use our skill and knowledge to harm a patient. Deliberate harm would be to put a patient at risk for a treatment we know doesn’t exist. Risk associated with procedure does not count as “doing harm” unless the procedure has no hope of benefit. We know conventional chemotherapy has the potential to cause illness, and even death – I know this personally because my brother died four years ago after his first dose of chemotherapy put his frail body into septic shock, from which he did not recover. Some suggested that because my brother had metastatic lung cancer that the chemotherapy robbed him of the few months he had- and therefore the physician went against nonmaleficence by administering a therapy that would not do benefit. But that chemotherapy was not to prolong Jimmy’s life- certainly there were no illusions that it would cure him – but he was suffering horribly, and it was hoped a reduction of the tumor burden would give him some relief. In surgery- we know there are risks involved, but if a patient suffers a known complication from surgery- it is not that the physician did harm – the surgeon did not violate the Hippocratic oath (most of us never took that oath, but we adhere to many of its principles, including nonmaleficience). In Dr. Burzynski’s case – if he knows the treatment won’t work, then he is doing harm – but if he believes it works he is not guilty of nonmaleficience.

Beneficence
This is the tenet that as a physician it is our duty to act in the best interest of the patient. This means to directly intervene, if possible, for the comfort and well-being of our patient. The key is that we are not the ones who judge this- it is the patient, and not the physician, that determines this – and involves other aspects besides health and survival. As a physician we must be trusted, we must be truthful, and we must respect confidentiality of our patients above all else. It is our goal to ease pain and suffering- and not cause it. And while not all providers and patients weigh this the same- this is not judged by the physician, only by the patient.

Justice
This is not judgement- this is the concept of fairness to all. While there are limited resources- we must find a way to make these resources to our patients in a fair manner. The transplant world deals with this in how organs are distributed among those in need.

Innovation and Research
Dr. Burzynski claims that he has a cure, or better treatment for cancer than anyone else. There have been phase 1 and phase 2 trials of these treatments, but no published phase 3 trials comparing them to standard treatments. But let us step back, because innovation is not the same, in medicine, as research.
Innovation is different than research. In surgery we innovate every day- no two operations are the same, and sometimes we do operations that we have never done before. That requires an informed consent with a patient- and an open and honest discussion. Some feel it involves an Institutional Review Board (IRB) – but it doesn’t This is where the patient has autonomy, this is where the surgeon has nonmaleficence, this is where he uses his Beneficience and justice to bring something to the patient.

That is different than research. In research, which is the systematic acquisition of data for the purpose of generalizable inference – this requires equipoise. Equipoise requires that even though we believe our treatment might be best, we provide different treatment arms so that it can be tested. Clinical equipoise is satisfied if there is an uncertainty in the medical community regarding the therapy (antineoplastons) and this allows the clinical investigator to do a trial until there is statistical evidence to convince the medical community about this treatment.

Because Burzynski has not satisfied the medical community with equipoise, we question the treatment- and can only be convinced by a phase 3 trial. Until he does- the medical community, and others- will remain skeptical of his treatment. Some have demanded he release his data to peer reviewed journals. That, of course, cannot be done. We cannot compel Burzynski to release his data. But that his data has not been reproduced by the accepted academic world in the United States will be an ongoing issue.
This means patients have to pay the high cost of his research, the high cost of getting treatment from him and that is because insurance companies won’t pay for treatment until that treatment passes through our standard method of evaluating therapies.

Given those pillars- what is Dr. Burzynski, as a physician ethically obligated to do? While he may not be required to do anything, medical ethics would require that he enter patients into phase 3 trials, comparing large groups of patients to random treatment arms, to determine if his treatment has more merit than others. If he does this than the medical community is required to respond, and open up those treatments to patients who wish to participate. Doing that in his own clinic, without having other non-vested physicians also treat him – is not satisfactory.

We believe strongly in ethics for physicians – and from an ethical point of view, Dr. Burzynski meets some of the pillars – but without a full and open process that can be evaluated by physicians that are not involved (and there are plenty of physicians who have stated his treatments are not as efficacious as standard treatments) – Dr. Burzynski fails at justice. If he has a cancer treatment better than others- and the only way it can be obtained is by paying thousands of dollars- then this represents a failure of one of the pillars of medical ethics.