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Is it truly unethical for one doctor to refuse to inform the patient about a research study by another doctor because of concern about losing the patient to the other doctor?

Here is a made-up scenario but someone in the pharmaceutical research profession tells me that this is not an unrealistic scenario.

Dr. R. has a patient with epilepsy who is not adequately controlled on any of the current anti-seizure drugs. Dr. R. is aware of a formal clinical study being performed in the clinic of Dr. S. with a new experimental anti-seizure drug that is being tested in hopes of benefit for intractable epilepsy patients. Dr. R. does not inform his patient about this study as an alternative option because of fear of losing the patient to the other clinic.

Here is the question: Is there anything unethical or unprofessional about Dr. R.’s decision not to inform the patient?

Now,here is one way of looking at the issue. Dr. R. knows that a new drug is studied in a research experiment because any beneficial effect on human patients is unknown or that the beneficial effect as compared to the best present treatment is unknown. He is aware that in a randomized study his patient might be getting the new drug with unknown benefit or the other drug to which his patient has not responded, then wouldn’t Dr.R.’s decision be ethically reasonable? Why? Because there is no proof at present that whatever drug was given to the patient in the experiment would be of any medical benefit.
When considering this rationale, wouldn’t the possible loss of a patient to another clinic trump any act of informing the patient about the research project?

I am eager to read what Medpedia readers think about the behavior of Dr. R. ..Maurice.
asked Nov 12, 2010 at 09:28PM in Other
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  • 0
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    answered Nov 13, 2010 at 01:44PM
    Hi Dr. Bernstein! Is this a trick question?
  • 0
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    answered Nov 13, 2010 at 02:03PM
    The simple answer is "yes."

    First, patients know, or can be informed about the risks inherent in a clinical trial and allowed to make their own decision. Secondly, adverse reactions not withstanding, the worst case scenario for the patient is that they would remain uncontrolled (i.e. no difference and no harm). Finally, every physician has an ethical, moral, professional and fiduciary responsibility to their patient to use their best medical judgment and knowledge to help. While I understand the reticence to refer a patient to a particular specialist who consistently never returns the patient to the referring physician when there are other equally qualified specialists available, there is no excuse for withholding the possibility of effective treatment when it exists, especially for no better reason than pecuniary gain.

    Finally, if the patient were referred to the other clinic and helped by the experimental medication, I believe they would be more likely than not to return to their original doctor on their own. The very act of having read of the study and referring the patient would engender feelings of trust and confidence in the patient and cause them to be more likely to return, not less.
  • 0
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    answered Nov 13, 2010 at 03:18PM
    Carolyn, "trick question?", not really. All doctors, especially those in private practice, have a potential conflict of interest to continue to have that person as his or her patient both from a emotional and financial point of view. Sometimes this conflict between holding onto a patient and yet still providing the patient an opportunity for further or better treatment is part of the professional requirement of putting the patient's best interest ahead of any self-interest. On the other hand, there might be debate as to what exactly is in the patient's "best interest". For example, being a subject (and notice I didn't write "patient") in a research study may not really be in the patient's best interest. Why? The subject may be, by chance, "subjected" to an experimental medication whose value and complete safety has not be as yet fully confirmed and since the study is usually "double blind", neither the researcher nor patient knows which drug or placebo is being administered to the patient. So this is an experiment and NOT a treatment and that is why the patient who is in such a study is a "subject" and NOT a patient. So there can be a very strong argument that the patient's participation in the study although possibly in the interest of all those patients with the disease who await the results of the trial might not be strictly in this patient's best interest. So there you are. participation by a patient is a mark of the patient's altruism and not a clear road to benefit or recovery.

    Eric, you have made a reasonable argument in favor of referral, though I am not sure how much a patient can be fully informed regarding the risks vs benefits of a clinical stage 2 (small scale, double blind after grossly apparent toxicity has been found to be unlikely in stage 1 volunteer open testing). That is because I wonder how the referring physician would also be fully aware of risks vs benefits. Irrespective of the physician's desire to keep the patient, should the physician be professionally required at all times to present to the patient every possible option for treatment or should the options be limited by the physician's professional judgment? ..Maurice.
  • 1
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    answered Nov 13, 2010 at 04:13PM
    "...this conflict between holding onto a patient and yet still providing the patient an opportunity for further or better treatment is part of the process of putting the patient's best interest ahead of any self-interest. .."

    Again, seems like a trick question to me. Since when is "holding onto a patient" considered to be "putting the patient's best interest ahead of any self-interest?" It hardly fits into the equation.

    As a cardiac patient, I can't even comprehend the intent of this question, in fact.

    If my cardiologist deliberately withheld information about available and appropriate clinical trials from me - particularly on the questionable and frankly paternalistic grounds that I wouldn't be capable of being "fully informed", or - as in your example - if my condition were "not being adequately controlled" - it would seem a sign of professional malpractice.

    I now happen to be a member of a very exclusive club that no patient ever wants to join (the wonderful world of All Things Cardiac) where we have a longstanding tradition of decades of cardiac research done either exclusively on male subjects or with women represented in statistically insignificant numbers.

    This has lead to a disturbing disparity, well documented in the literature, of gender differences in diagnosis and treatments for women, many of which result in our well known poorer outcomes compared to men. Although, happily, this is slowly changing, the reality is that although women represent over half of all heart patients, we make up less than one quarter of cardiac research participants. Why? Are our doctors making similar assumptions that we somehow aren't appropriate for research on a "male" disease, or are we simply incapable of being "fully informed"?

    Again, smacks of overt paternalism.
  • 0
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    answered Nov 13, 2010 at 07:09PM
    Carolyn, what I was trying to express is 1) Attempting to "hold on" to one's patient could be read as a sign of "self-interest". 2) Providing the patient an opportunity to improve therapy is part of considering the "best interest" of the patient. Generally, as you agree, the patient's best interests should trump the physician's self-interest. I agree too. The ethical question is, however, does enrolling a patient into an experiment also lead to a result which could be read as "best interest for the patient"? Some may argue not for the reasons I detailed above. For example, consider that the situation was that both doctors were neurologists but the other doctor, Dr. S, had perfected an established electro-physiologic technique which was proven safe and effective for those who did not respond to the available drugs for epilepsy. Supposing, to treat the patient with this technique required specific skills that Dr. S. had but the patient's Dr. R. did not have. For Dr. R. to deny his patient the treatment skills of Dr. S. because Dr. R. wouldn't want to permanently lose the patient to Dr. S. to me would be unethical because it put Dr. R's self-interest over that of the best interest of the patient. I hope you see the contrast in this second scenario as compared with my first one where the patient could be referred into an experimental research process where neither safety nor benefit could be promised. ..Maurice.
  • 0
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    answered Nov 13, 2010 at 07:58PM
    Maurice,
    While a physician's "recommendations" must always be tempered by his or her best clinical judgment, that does not excuse refusing to present the opportunity to participate in a potentially beneficial study to the patient. It is certainly true that a physician referring a patient to a clinical study may not possess all of the knowledge necessary for the patient make an "informed" judgment, but the investigator does. Once referred, all such information is required to be presented to the potential subject, and they can then make a decision. They can even discuss it with their personal physician before deciding.

    As for whether it should be required for a physician to present each patient with every potentially "viable" options for treatment, I believe it should be. Of course, no legitimate physician should be required to elaborate on "treatments" that are neither proven, nor under investigation. Sending a patient to Mexico for cancer treatment with apricot pits is not required and, indeed, would violate the trust inherent in the physician - patient relationship. On the other hand, we're not discussing such "quack nostrums" here, but therapeutic research.

    I reiterate that since the question asked was whether it is ever ethical for a physician to refrain from referring a non-responsive patient into a potentially beneficial study treatment simply to hold onto the patient, my unequivocal answer remains "no."
  • 0
    Votes
    answered Nov 13, 2010 at 10:19PM
    Eric, I must say that not only the patient's physician is unaware of all the risks and is unaware of whether the drug is beneficial but the same should apply to the researcher. After all, clinical studies to develop new and potent medications require statistical control to establish proof. Virtually all controlled studies require at least two "arms" of the study (unknown drug vs known drug or unknown drug vs placebo) and that at the outset that the experiment the assumption by the researcher should be that there is equipoise. Equipoise means that the investigator must assume for statistical analysis that one arm is no better and no worse in its beneficial effect than the other arm. That is,.the unknown drug is no better and no worse than the known drug or even a placebo (a chemical which is thought to have no therapeutic benefit). Have patients who are considering entering a study understand that such studies are to determine benefit or greater benefit and the assumption on entry is that there is no greater benefit, if any? And even the risks of the unknown drug are not fully known?

    There is great demand for subjects in clinical studies but there is inadequate education and detailing of what the subject should understand and expect on signing the consent forms given to them. Even if the studies have been approved by the Food and Drug Administration and the plans reviewed by legally established review boards, bad thing have happened as examples noted in this
    article "Major Gaps in Oversight of Human Medical Research" http://www.huffingtonpost.com/2009/10/28/major-gaps-in-oversight-o_n_337399.html

    What I am getting at with all these words is despite the fact that yes it is the professional duty to look to the best interest of the patient. Yes, it is a professional duty to inform the patient of all options which could provide benefit with limited risk to the patient. Yes, patient interest trumps self-interest of the physician. Yes, human medical research and development of treatment, at present, can't be accomplished without human subjects. Nevertheless, the physician should not assume that informing and then introducing a patient to a research study is always an ethical good, particularly if the patient is not near death from a terminal disease (where there might not be anything to lose unless the study prolongs the death with more symptoms!). Anyway, that is my opinion. ..Maurice.
  • 0
    Votes
    answered Nov 14, 2010 at 06:19AM
    Best Answer
    Maurice,
    We're diverging into two different discussions here, so let's dispose of the initial question first. It is never ethical for a physician to place his own self interest ahead of the patient's. It would, indeed be wrong, in all aspects, to refrain from informing a patient about a new treatment or study simply to "hold on to" that patient.

    With that said, I'll address your other points regarding clinical trials. I agree that there are frequently reasons why a physician might, and perhaps should recommend against a particular patient taking part in a particular trial. First, as you mentioned, while it is the obligation of the investigator to inform each subject regarding known adverse reactions, part of the reason for the trial is to determine both efficacy AND any additional adverse reactions. The risk could be substantial and subjects must be made aware of that before agreeing to participate.

    Secondly, and also as you described, well controlled studies are "double blind" whenever possible so that results are not skewed by researcher expectations. If there is evidence that a particular study drug may be more effective than a medication a patient is already taking, they need to understand that when they enter the trial, there is a high probability they will be administered a placebo and their condition may worsen rather than improve.

    Finally, this brings me to your last point. There are times when it is incumbent upon a physician to actively discourage a patient from participation (except for a terminally ill patient with no other known effective treatment, of course). If a patient were either "mostly" controlled on a current medication and/or well controlled but with mild and tolerable side effects, I might very well discourage entering a stage II trial (keep in mind you never stated which stage trial was involved in the beginning). While I want all legitimate research to go forward, my obligation to my individual patient would still trump my obligation to Science, Medicine, and society in general. Ultimately, all of these decisions are resolved in favor of that favorite "First Rule of Medicine;" PRIMUM NON NOCERE (First, do no harm).
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