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Restrictions on business relationships with industries, and their unintended adverse consequences.

Conflicts of interest have resulted in biases that have affected clinical decision making and medical research. Most such situations breach the highest standards of medical ethics and are legitimate causes of concern for the medical community, the general public, and legislators. Occasionally, biases and their consequences have been egregious. In an effort to control conflicts and prevent undue influence by industry on medical care and research, new rules and guidelines are being implemented. Most medical schools and many hospitals have developed policies that are consistent with a report from the Association of American Medical Colleges, "Industry Funding of Medical Education." (1)

The policies are designed to encourage a culture of ethical professionalism and to avoid conflicts of interest. The written policies at most institutions seek to define acceptable interactions between faculty/employees and companies that produce pharmaceutical products or medical equipment, or that provide services to the medical community. They seek to define relationships between industry and physicians in order to be certain that they are principled and do not result in bias, and that they minimize the influence of companies on patient care, purchasing and prescribing decisions, and medical research.

Policies emphasize that decisions should be based on evidence-based sources, not marketing efforts. In general, most policies attempt to include all faculty and staff activities, whether on or off campus and whether they occur during the scope of employment or one's own time. Some even attempt to include immediate family members within an institution's policy. In addition, academic institutions also attempt to include within their policies not only employed faculty, but also noncompensated volunteer faculty and their "significant others." While the feasibility, practicality, and legality of such policies are still being debated, their existence provides some insight into the scope and vigor with which this problem is being attacked. A review of typical restrictions highlights the current regulatory ardor.

Typical policies regarding "meals and gifts" hold that professionals may not accept gifts, hospitality, services, or subsidies of any sort from industry, and neither may guests of professionals. This means, for example, that the pizza that used to be provided by various companies during resident lectures and rounds has disappeared, leaving many medical schools "food-free" in their educational programs. While it is hard for most of us to remember which companies bought pizza or Chinese food for our conferences once a year, and while most of us are quite certain that a slice of pepperoni pizza did not influence our prescribing patterns, this kind of minor industry support during physician training has become a tradition of the past. Similarly, policies hold that industries can only provide financial support for CME (Continuing Medical Education) or non-CME activities directly to an institution or department, not to an individual physician. Such support requires a formal letter of agreement with the industry, full transparency, and disclosure by any presenter whose activities are funded by such industry-derived support.

Contact by industry members with academic physicians is also limited. Industry representatives are precluded from informing professionals on institutional property (education, administrative, or clinical offices, for example) of promotional events, or from meeting with professionals during office hours. They also preclude representatives from any direct interaction with patients and from attending professional conferences unless specifically invited or serving as a sponsor of the conference. This essentially eliminates contact between "drug reps" and physicians; and it also can be interpreted as precluding preceptorship in physicians' offices for industry professionals. The potentially serious adverse consequences of this facet of the policy are discussed below.

The policies also provide that pharmaceutical samples must be logged in and logged out, stored in a central location, and audited periodically.

Institutional professionals who are involved in formulary and purchasing decisions are required to disclose any financial relationships with industry that provides products under consideration, or competitors. They are also required to recuse themselves from the selection process, whenever possible. While this portion of the policy makes some sense, especially the disclosure portion, eliminating professionals with extensive experience with industry may also mean eliminating the professionals most knowledgeable about the factors that should be considered when making formulary and purchasing decisions.

The policies also preclude physicians from participating in industry's "speakers' bureaus." This makes it unethical for a physician to deliver an FDA-approved slide lecture to market an existing product, but it does not prevent an individual from delivering lectures containing his/her own information, and receiving an honorarium and/or expense reimbursement for giving that lecture. It also requires that any advisory board or industrial consulting assignment that results in any significant income (in our institution, exceeding $300 per year) be reported to the institution, and that any fees exceeding $10,000 or a 5% interest in the sponsor be reported as a conflict of interest.

Institutional representatives are designated to establish plans to resolve conflicts of interest. The institution (for example the department chair or vice-dean for research) also has to receive (and often approve) a written contract that establishes compensation for anyone at the institution with an advisory board membership or consulting agreement. Funds provided to a professional for attending a conference or educational meeting to learn (rather than present) are precluded; and support for residents and other trainees can only come in the form of educational grants donated to the institution or one of its departments.

One of the strengths of the new policies is a requirement for professional education for healthcare professionals and trainees. Lectures are required to educate medical professionals on how promotional activities may produce subtle biases and influence judgment. Various institutions have addressed the issue of preceptorship in different ways. Preceptorships are training sessions in which an industry representative spends time (often a day) observing a physician in the office or in the operating room. Some policies preclude these altogether. Other institutions permit such activities so long as there is an executed business agreement and the patients have authorized the industrial representative to be present and observe. The issue of preceptorships is discussed further below.

Appropriately, ghostwriting is proscribed by policies at most institutions that regulate business relationships with industry. Ghostwriting involves a physician or scientist putting his/her name on a manuscript written by industrial representatives. It also applies to ghostwritten oral presentations. Ghostwriting is unethical, and there is little argument regarding this policy. This does not mean, however, that a professional who has established his own content may not hire a professional writer or editor to help polish it. It only means that a professional cannot endorse industry-written materials by falsely claiming authorship.

While conflicts of interest and ethical breaches are troublesome and need to be controlled, enthusiastic and broad policies sometimes create problems that could (and should) have been anticipated. We can expect problems from several components of the new policy initiatives. Two of the most obvious (and potentially the most damaging) involve preceptorships and access of pharmaceutical representatives to physicians.

The issue of preceptors in physician offices is the less complicated of these issues. Institutions that permit preceptorships but require written agreements and controls have the problem solved. Institutions that do not allow industrial employees (pharmaceutical, device, equipment, etc.) in their academic institutions, patient offices, or operating rooms are shortsighted, however. Such preceptorships are educationally valuable in several ways. Traditionally, many such preceptorships have been arranged with pharmaceutical representatives (drug reps). This is not just a ruse that allows drug reps to spend more time with physicians. Many drug reps are academically serious, well-educated professionals, often with degrees in nursing or pharmacology. The more they understand about the medical conditions for which their products are prescribed, the better they are positioned to educate not only other physicians, but also other professionals within their industry who determine internal research and development priorities, as well as allocation of marketing and research funds.

In addition, there is another important group of industrial representatives who do preceptorships. These include directors of research, directors of development, design engineers, and others who have influence within various industries and who help determine allocation of industrial resources. For example, I have been involved in the development of a variety of surgical instruments. In order to convince a manufacturer that it was worth investing considerable dollars (research, design, FDA approval, etc.) in these projects, corporate representatives were invited into the operating room to help them understand the clinical problem and the shortcomings of existing technology. Once the commitment was made, representatives of the design and engineering group benefited from trips to the operating room to see what we were trying to accomplish with the instruments, and to understand shortcomings of the first prototypes. If these members of industry had not been allowed the opportunity for firsthand education, these new instruments never would have existed, and the patients they have helped would probably have less-desirable outcomes. This example represents a conflict of interest; I acknowledge it.

The issue of keeping pharmaceutical representatives away from physicians is of greater concern. Drug reps do more than drop off samples and (in the old days) occasionally bring lunch to the office. They provide valuable information about drugs, side effects, complications, and other problems that most of us do not have time to acquire consistently on our own, especially when the information is published in journals with a targeted audience outside our specialty. To highlight the potential importance of this kind of education, I will provide two examples related to a drug class used commonly by otolaryngologists: proton pump inhibitors (PPI). I will be surprised if there are not readers of this journal who are unfamiliar with at least one of these problems, and I will also be surprised if there are not readers who acquired their information on these important issues initially through their pharmaceutical representatives.

The first issue is now fairly well known. In 2006, Yang et al reported an increased risk of hip fracture in patients on long-term proton pump inhibitor therapy. (2) Since patients treated for laryngopharyngeal reflux (LPR) often receive PPI therapy for months or years, the increased hip fracture rate is particularly important to us. The fact that the article reported a higher incidence in men than in women was surprising, since osteoporosis is more common among women; and many of us have interpreted that as suggesting that the calcium replacement used commonly by women for osteoporosis (and rarely by men) may have a therapeutic effect. Consequently, pending further data, many otolaryngologists have been making sure that our patients (especially elderly patients) receiving long-term PPI therapy are using calcium supplements. Since there is still a high mortality rate associated with hip fracture, and since PPIs may be necessary because of the cancer risk associated with uncontrolled reflux, otolaryngologists need to be familiar with these issues. However, not all of us read JAMA or gastroenterologic literature on a regular basis.

Second, I suspect that many otolaryngologists still are not aware of the apparent increase in adverse outcomes in patients taking clopidogrel (Plavix) while on PPIs. Plavix is prescribed commonly as a platelet inhibitor to control arterial thrombosis. It is often prescribed in combination with aspirin, particularly after myocardial infarction and stent placement. It has been established that omeprazole decreases the antiplatelet effect of Plavix. (3)

In a study published as a letter to the editor, Pezalla et al, on behalf of Aetna Insurance, investigated myocardial infarction rates for patients on Plavix with and without PPIs. (4) They found that myocardial infarctions occurred in 2.6% of patients on Plavix alone, 10% of patients on Plavix and low-dose PPI, and 11.4% on Plavix and higher-dose PPI. The PPIs used were not specified. However, a study by Siller-Matula et al found that the interference with Plavix caused by omeprazole did not appear to occur between Plavix and esomeprazole or pantoprazole. (5)

In a study of more than 8,000 Veterans Affairs Hospital patients, Ho et al confirmed increased adverse outcomes (including death) in patients on Plavix who were also taking PPIs. (6) Otolaryngologists who treat LPR frequently, and who treat many patients who are on Plavix, need to know these facts; and we need to know that the problem associated with omeprazole (which many insurance companies force patients to use) may not exist with later-generation PPIs. Unless we happen to read the Journal of the American College of Cardiology, The Medical Letter, and JAMA, our most likely early source of such information may be our drug reps. In this case, that information could save lives.

To conclude on a really controversial note, one might even argue that not all industry-related biases are bad. I believe that everyone agrees that prescribing a medication because the drug rep took us to dinner is unethical and unwise. I also do not believe this occurs commonly. However, if I have a choice between two medications with equal efficacy ("equal efficacy" must be emphasized) and know that one of the two pharmaceutical companies provides generous support to academic institutions for research, development, and education, I am inclined to support that company, all medical considerations being equal. Is that biased? Yes. Is it unethical? I don't think so.

It is clear that issues of conflict and bias are complex. They certainly need to be addressed, controlled, and resolved. Medical and industrial advances are inextricably intertwined. Any policies implemented should be thoughtful, flexible within rigid ethical boundaries, and designed to enhance practical, creative collaboration between medical science and industry, not stifle it.

References

(1.) Association of American Medical Colleges. Industry funding of medical education: Report of an AAMC Task Force. 2008. www. aamc.org/publications. Last accessed April 8, 2009.

(2.) Yang YX, Lewis JD, Epstein S, Metz DC. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA 2006;296 (24):2947-53.

(3.) Gilard M, Arnaud B, Cornily JC, et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: The randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coil Cardiol 2008;51(3):256-60.

(4.) Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug Interaction between clopidogrel and proton pump inhibitors. J Am Coll Cardiol 2008;52(12):1038-9.

(5.) Siller-Matula JM, Spiel AO, Lang IM, et al. Effects of pantoprazole and esomeprazole on platelet inhibition by clopidogrel. Am Heart J 2009;157(1):148.e1-5.

(6.) Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009;301 (9):937-44.

Robert T. Sataloff, MD, DMA, FACS

Editor-in-Chief

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Title Annotation:EDITORIAL
Author:Sataloff, Robert T.
Publication:Ear, Nose and Throat Journal
Date:May 1, 2009
Words:2422
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