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¶ … Medical Ethics Concerns

Results of requested research on medical ethics concerns; recommendation

Gracie and Keith,

You had asked me to investigate the current state of medical ethics, and to make a recommendation, based upon my research, as to whether or not we should request an affidavit from Dr. Smathers that she is not involved in ethically questionable behavior. Based on my research, which will be detailed here, I would recommend that we not request this of Dr. Smathers.

Questions Raised about Relationships to Medical Providers

Pharmaceutical and medical device suppliers depend on a close relationship with medical practitioners for new ideas, and to develop and test their new devices or pharmaceutical products. Quite apart from their ultimate commercial needs, there is a need to relate real-world clinical practice to innovation; without such close collaboration, the pace of medical innovation would slow down. This note outlines two areas of potential concern: (1) collaboration on research and clinical trials, and (2) collaboration on marketing and clinical presentations.

Research and Clinical Trials

There are a number of physicians whose opinion is sought out more than others. To some degree, this attraction is governed by the physicians' talents as researchers or in conducting clinical trials. Clinical trials and research require a good deal of record-keeping, scientific rigor and ethical probity. These requirements therefore limit close collaboration to a limited number of physicians who have both the interest and aptitude to support such research.

These physicians are generally well-respected in the medical community, are well-published, and have a reputation for presenting good work. Although a physician may have a number of projects under way with several pharmaceutical companies, it is not in the physician's interest to shade the data, or to make a device or pharmaceutical product appear better than it actually is. The reasons for this include

The recent decision of the FDA to make all data available to the public, thus allowing a 'second look' at clinical trial participants, their modes of data collection, and the accuracy of their conclusions. These standards are incorporated in government and private enterprise bodies, such as CDISD (CDISD 2007).

Clinical trial watchdogs, such as the Union of Concerned Scientists and Public Citizen (Wolfe 2006), pore over such data to insure that the trials are run in an unbiased fashion

In addition, those journals which publish the results of such studies are judged by professionals, who require any indication of sponsorship or bias to be declared by the participants in studies (NEJM 1993).

There have been exceptions to the above, where physicians have, in the opinion of their peers, overstepped their boundaries and represented the medical suppliers' interest more than their patients or the value of their science. A recent case, involving Dr. Martin Leon of Columbia, was particularly egregious. Dr. Leon revealed evidence from a clinical trial prior to its 'unveiling' date, which caused a significant movement in the stocks of several medical device companies. The response of the medical community was immediate and severe. Dr. Leon was suspended from editorial boards of the Journal of the American Cardiology Society and the New England Journal of Medicine for at least five years (Wood 2007). Dr. Leon's reputation as a clinical trials clinical investigator and participant was therefore permanently disadvantaged.

Training and Presentation in Medical Conferences

Physicians such as Dr. Smathers participate in colloquia and congresses, and present teaching seminars about the use of medical devices and new pharmaceutical regimens. A concern of some is that this representation of the company can result in an endorsement of the company. A second concern is that the physician may allow his or her judgment to be compromised by their relationship with the company.

On the first concern, there is a pressing need for experienced physicians to teach others how to improve their practice. The rules (as above for clinical trials) are strict about what is presented, and how it is presented. The physician must present all sides, supported by clinical evidence, with a clear indication of side-effects and contraindications.

On the second concern, there may be an effect on the physician's prescribing behavior if he/she believes in the product. There is, by law, no direct relationship between the prescription of drugs or medical devices and pharmaceutical products and physician remuneration. Even the conversations between physicians and "drug reps" are carefully scripted, and bounded by the need to disclose negative and positive points of a drug or device.

Additional Reasons for Dr. Smather's Concerns

Dr. Smathers is bound by peer review, reputation and the conditions of her Hippocratic Oath. She may have been taken aback by our request for her to file an affidavit certifying that she is not "a crook" (a la Richard Nixon). This negative assertion would, in Dr. Smather's mind, be already covered by her oath and reinforced by the strictures of her profession.