Physician Ethics and Dr. Burzynski

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.

Dr. Terry Simpson About Dr. Terry Simpson
Dr. Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. He found he liked people more than petri dishes, and went to medical school. Dr. Simpson, a weight loss surgeon is an advocate of culinary medicine. The first surgeon to become certified in Culinary Medicine, he believes teaching people to improve their health through their food and in their kitchen. On the other side of the world, he has been a leading advocate of changing health care to make it more "relationship based," and his efforts awarded his team the Malcolm Baldrige award for healthcare in 2011 for the NUKA system of care in Alaska and in 2013 Dr Simpson won the National Indian Health Board Area Impact Award. A frequent contributor to media outlets discussing health related topics and advances in medicine, he is also a proud dad, husband, author, cook, and surgeon “in that order.” For media inquiries, please visit www.terrysimpson.com.

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Latest Comments

  1. Christopher says:

    I personally feel that most doctor worldwide could give two shits about the people they treat. I have lost 8 famly members to cancer. And u so called doctor can only seem to do one thing collect the pay Check. And now that a doctor has found a better way of treatment u are willing to nail him to the cross. U have know idea the out rage I’m feeling at this point! My father has battled with colen can three different times. It in remission at this time but was it worth it. U doctors have dam near kill him in the last few years with the radiation and other medication. I my self suffered. At the hands of lesser doctor do to ignorance. But that is a mother case. How ever ur truly only concerns seem to how much money I’m I going to lose if this man, this doc tor. A true servant of the people can cure cancer for good with out making it a repeat business. I served my time in this country’s army special forces. I have seen many horrible things. But nothing makes me more ashamed then this countrys greed.
    Signed : Christopher. Wilson

  2. The Doc says:

    Sorry to hear about your father – but let me be very clear. If there was a cure for cancer, or a better treatment- then let it be tested against the treatments that we have. Burzynski doesn’t – and he charges patients a lot of money for a treatment that isn’t proven. So, yes, we do care about the people we treat.

  3. Jon says:

    Dr Simpson, I enjoyed your video and the reasonable and impartial assessment of Dr Burzynski’s motivations. And, I too agree that Burzynski ‘must’ complete the Phase III trials, both expeditiously and transparently. However, I’d ask you to comment on the extraordinarily high cost related to the Phase III trials and how Burzynski could possibly afford to activate the trials with such an inhibitive price tag? I think it’s also important to reflect on the difficulties Dr Burzynski has faced on the occasions he has dealt with pharma companies, the NCI and the FDA. For example, the defection of his chief scientist to Elan and their registration of patents on components of antineoplastons while the FDA attempted unsuccessfully to incarcerate him. Not to mention, the NCI’s amendment to trial protocols without his consultation or agreement. I am not surprised by Burzynski’s reluctance to ‘trust’ other parties to conduct trials for these reasons. So, what is the solution? I am interested in your opinion. Yes, I am a believer in Burzynski (after much research and consultation with qualified practitioners, both skeptics and believers, patients and others). But, I always reserve a kernel of doubt as motivation to continue my research. I liked your video piece because you are objective your evaluation as opposed to the ‘blammers’ that have a single intent to maliciously discredit and defame Burzynski and anyone associated with him – including his patients. I can’t disagree with anything you pointed out, but I can also see the dilemma faced by Burzynski in achieving recruitment for the Phase III trials (incidentally, it could be argued that the protocol itself is a deterrent – what parent wilfully agrees to have their child subjected to radiation). So, given these hurdles, what do you believe is the answer? I am happy to engage with you in this discussion via email if you would prefer.

    I would like to make a final point directed at Christopher. Firstly, I am sorry about your father. It’s a tragedy. I lost my mother after a nine year battle with breast cancer in 2009. I understand the anger. However, I firmly believe that 95% of doctors enter the medical profession for the noblest of reasons – to help people – and 90% of stay true to that purpose until retirement. If there is a problem with the industry, it stems from the arrogance and greed of top-level bureaucrats and high-paid executives and their abuse of the faith and trust offered to them by their industry members. Where there is an industry, there is always corruption. It would be naive to think the health industry is immune. It won’t be. We are simply yet to determine how far the ‘cancer’ has spread.

  4. The Doc says:

    There is a lot that you are asking and let me put it this way: If there is something to what he is offering, then there will be more than enough money to pay for the trials.
    A few other points- The FDA does not incarcerate- it has no authority to do that.
    NCI always adds amendments to trials – part of the business.
    The system we have in place is sound- show the worth with open source data.

  5. Steve Smith says:

    Can you explain why the NCI is forcing him to add radiation treatment to his trials. That is the very thing he is trying to avoid. If the testing is for HIS treatment, how can they add their deadly treatment to the test. That’s like saying, were testing this new pain reliever but you have to wash it down with antifreeze.
    I don’t blame him for trying to get that addition removed from the trial. The only sense it makes is to try to get him to fail.

  6. The Doc says:

    I don’t know that anyone is forcing him to do anything. When we have trials we have to compare with treatments. If we have statistics about a treatment that works, then we compare to that treatment- that is how a trial is done. One cannot have a trial without comparing to what we know works- and it is best to have the trial such that it is blinded to both the patient and the researcher, only a non-interested third party has the key to who received what and what their ultimate result was.

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