The Official Website of
James Matthews, M.D.
James Matthews, M.D.
526 Palmtree Dr.
Gaithersburg, MD 20878
(301) 325 – 8826
Date: 2/7/2011
To:
Russell McIntyre, Th.D.
Russell McIntyre, Th.D. 1943 S.W. Palm City Road, Apt. J Stuart, FL 34994Re:PRIM-E, Final Essay
PRIM-E, Final EssayI believe that the Maryland Board of Physicians required me to take this course for several reasons:
1. I was essentially treating patients with a new disease, Morgellons, with innovative therapies, and without any oversight such as with an independent review board.
2. I had entered into a contract with one of these patients specifically to continue with innovative therapies.
3. The disease has been associated in some patients with psychiatric conditions and while my patient was shown to have been fully competent, I believe that the Board was thinking I should have done a better job in showing this before signing a contract with the patient, and having the patient sign an informed consent form.
My response: Guilty as charged, but with an explanation:
I never set out to develop innovative therapies for these patients. These folks presented to my office out of desperation, and it was obvious to me that they were suffering with some kind of infectious, not a delusional, condition. Primary care physicians are taught to be on the lookout for sentinel cases which may indicate an emerging epidemic, so I felt like I was just doing my job, however, now that I’ve taken the PRIM-E Course, I’ve learned that there are much better ways of handling such situations.
For starters, I’ve learned that the Ethics Manual in the Annals of Internal Medicine, the medical ethics position paper most often cited when a question of medical ethics goes before a court of law, defines innovative therapies to include the use of unconventional dosing of standard medications, previously untried applications of known procedures, and the use of approved drugs for non-approved indications. All of the things I had been doing in the Morgellons patients. Also, the Manual goes on to say that, ‘When considering an innovative therapy that has no precedent, the physician should consult with peers, an institutional review board, or other expert group who can help them to assess the risks, potential adverse outcomes, potential consequences of foregoing a standard therapy, and whether the innovation is in the patient’s best interest.’ So, while I may have had the best intentions for the patients, had I been familiar with the Ethics Manual in the Annals of Internal Medicine, I could have done a much better job involving more people so that proper independent review, which is a fundamental principle of ethical research, could have taken place.
After consulting with peers, an institutional review board, and other qualified experts who can help the clinician to assess the risks, potential adverse outcomes, potential consequences of foregoing standard therapy, etc… the clinician will be in a much better position to develop a proper informed consent, and while the Board’s independent reviewer had indicated that the “Therapeutic Relationship” documents that I had had my patients signing “had sufficient elements to constitute an informed consent,” I sensed that the Board still had concerns about this so I paid particularly careful attention to information about informed consent in the PRIM-E Course, and therein, I learned that ‘the doctrine of informed consent goes beyond the question of whether consent was given for a treatment or intervention. Rather, it focuses on the content and process of consent.’
The basic elements of informed consent, (paraphrased from the Ethics Manual) include the physicians ensuring that the patient, or the surrogate, is adequately informed about the nature of the patient’s medical condition and the objectives of, alternatives to, possible outcomes of, and risks involved with a proposed treatment. The principle and practice of informed consent rely on patients to ask questions when they are uncertain about the information they receive; to think carefully about their choices; and to be forthright with physicians about their values, concerns and reservations about a particular recommendation. Additionally, all adult patients are considered competent to make decisions about medical care unless a court declares them incompetent. In practice however, physicians and family members usually make decisions about a patient’s competence without a formal hearing, though, the graver the consequences of the decision to consent to the proposed therapy or not, the greater the proof of capacity the physician should require.
Going into the future, now that I’ve taken the PRIM-E Course, I do believe that should I choose to engage in therapeutic innovation again, for Morgellons, or for any other disease processes, I will be better able to successfully carry forth the concepts of ethical clinical investigations and informed consent into my practice. In retrospection of my actions, I believe that I had been aware that contacting peers for input was a good idea, and had actually contacted several local dermatologists and infectious disease specialists, however, upon meeting some significant resistance, with folks being closed minded to the notion that we were seeing patients with a new clinical syndrome, eventually, became a little impatient and began working mostly just based on the guidance of the Morgellons Research Foundation. My intentions were good, however, when I became too busy to keep up with all of the necessary documentation for the reasoning behind the Foundation’s methods, I ran into a problem upon a review. Had I taken the time to obtain an Independent Investigator’s number, develop a relationship with an institutional review board, and put together another group of peers or other experts to assist me in developing the protocols and informed consent documents, I could have avoided the appearance of somewhat careless work, and while all of these steps take significant amounts of time and effort, and many patients will suffer in the meantime, I now see them as the only acceptable method we have to ensure that clinical research is always being conducted with the highest degree of professionalism and care for the patient, and as needed, will personally be able to carry these concepts forth in my practice in the future.
Sincerely,
James Matthews, M.D.
References
1. PRIM-E, Professional Renewal In Medicine (through) Ethics, with Russell L. McIntyre, Th.D., University of Medicine and Dentistry of New Jersey, January 21 – 23, 2011.
2. Snyder, L., JD; Leffler, C., JD; for the Ethics and Human Rights Committee, American College of Physicians. Ethics Manual. Ann Intern Med 2005; 142: 560 – 582.
