A major health professional association sent an invitation to an upcoming continuing medical education (CME) program on a topic in metabolic disease. The invitation stated that the program was about the use of a specific drug for this disease state. The program not only was going to feature a speaker who was a paid advocate for that drug, but it also was scheduled to occur at the offices of the manufacturer of that product!
A recent editorial by Dr. Arnold Relman, former editor of the New England Journal of Medicine, bemoaned the corruption of the process of postgraduate CME by the influence of major pharmaceutical companies.1 One of the published letters to the editor responding to this editorial criticized Dr. Relman's stance by noting that, while he was editor of the New England Journal, pharmaceutical company advertising and donations constituted a large percentage of the revenue of that publication.2
These examples serve to illustrate the growing quandary regarding the structure and function of CME in the United States today. Although there is a stated desire on the part of most health organizations and professional groups to distance program content and function from the influence of pharmaceutical companies,3,4 this goal has proven exceptionally difficult. Medical professional organizations are highly dependent on the financial support drug companies and other vendors provide to educational functions. Pharmaceutical companies want those educational experiences to be supportive of their specific market position. And, given the potential for corruption in that dynamic, outside agencies are becoming increasingly involved in the regulation of this process.
These issues are very important in diabetes care. As a disease state,diabetes and related metabolic disorders are the subject of increasing focus for pharmaceutical companies. More and more drugs are being introduced or investigated for the treatment of these conditions. And, as is well recognized, the size of the market for diabetes-related products is growing. How are these trends influencing the quality and objectivity of CME in diabetes? This article and the next will examine this important question.
Pharmaceutical Company Influence on CME
Available data on the interaction between pharmaceutical companies and educational or professional organizations suggest that there is a growing dependence on drug company support of medical education.5,6 Independent organizations now estimate that > 40% of the funding for CME comes from pharmaceutical companies compared to 17% 10 years ago. The intensity and complexity of efforts by the pharmaceutical industry to influence the continuing education of health professionals was cited by a comprehensive analysis of the subject in 2000.7 Drug companies were estimated to spend $8,000-11,000 per year per physician to influence physician education and knowledge. Intermediary companies that manage CME efforts for many pharmaceutical companies sponsored various educational programs costing an estimated $343 million in 1999.8 That figure was growing at a rate of almost 20% per year.
The evidence suggests that CME programs sponsored or influenced by pharmaceutical companies are more biased than those without such influence. A majority of physicians attend CME programs with such influence.9 These programs favor the product or products of their pharmaceutical-industry sponsors.7
Various analyses over the period from 1994 to 2000 suggested that this massive informational effort by pharmaceutical companies did affect physicians' prescribing patterns. In addition, physicians exposed to such efforts for certain drugs were found to favor those drugs in both their work on formulary committees and their educational presentations. The studies suggested that these changes in physician attitudes and behavior were not always “rational.” Pharmaceutical company efforts to influence CME content specifically are intense and often effective.10 In addition, academic physicians and medical residents were found, in a separate study, to be surprisingly naïve about the possible biases inherent in pharmaceutical companies' educational efforts about their products.11
The “Medical-Industrial Complex”
In an editorial on this problem, The Lancet8 referred to the “medical-industrial complex” to describe the close interaction between pharmaceutical companies and the powers that govern much of the available CME. Much available data suggest that this complex does exist. Professional societies see economic support from drug companies as an increasingly important part of their budgets.12 The medical journals they publish are also dependent on drug company donations and advertising.13 Specific questions have been raised about the lucrative practice of publishing sponsored symposia devoted to specific products of drug companies.14 By selecting the authors, who serve as featured speakers in these symposia, drug companies can configure “experts” in the field who are supportive of their products. These same company-sponsored experts are featured in educational symposia held by intermediary organizations but paid for by the companies. The sales representatives of the companies then further boost the“expertise” of these individuals by citing the articles and programs they were paid to present to physicians during their sales calls.15
This dynamic results in a codependency among the three groups involved. The professional organizations need the financial support. The“experts” look to these relationships to boost their incomes and professional standing. The pharmaceutical companies view the two other groups involved as important vehicles to help spread key messages about their products and to validate these messages.
The primary question about this system is its objectivity. A front page article in The Wall Street Journal described the elements of the interactions in this complex and the concerns about the opportunities for critical, objective presentation of data about the drugs of the companies sponsoring specific educational sessions.16 The Journal article pointed out that there is evidence that such“experts” know that they have to present data on company products at these events in the most positive light possible if they wish to continue to be engaged by companies as speakers.
Relevance to Diabetes Care
There are many clear examples of this medical-industrial complex in diabetes care. Perhaps the most publicized of these was the case of Parke-Davis, Inc., and the use of Neurontin for painful diabetic neuropathy.5 Others include the use of a limited number of speakers by device vendors to give multiple talks for insulin pump therapy and the use of a very limited number of speakers by pharmaceutical companies to present programs in favor of using thiazolidinediones in the treatment of type 2 diabetes. The aspect of these“expert”-corporate interactions that evokes perhaps the most concern is the situation that arises when very few speakers present so many programs that there is the potential for this activity to constitute a substantial income source for them. That possibility could certainly bias the content of such programs.
Regulation and the CME Provider Companies
In 1997, the Food and Drug Administration (FDA) issued guidelines that restricted drug company speakers from discussing off-label uses of approved drugs in company-sponsored events.16 Speakers could discuss off-label uses of drugs in CME presentations sponsored by accredited CME providers. This step was taken, in part, because of allegations that pharmaceutical companies were encouraging paid speakers to advocate off-label uses of approved drugs, especially Neurontin.5 These regulations were overturned in a court ruling the next year.17 Nevertheless, almost all of the drug companies got the message.
The pharmaceutical industry association Pharmaceutical Research and Manufacturers of America (PhRMA) issued its “Code of Interaction with Healthcare Professionals.”18 This code advocates that programs held by companies themselves focus on presenting the products of the company. A similar code was recently introduced by the medical device manufacturers'Advanced Medical Technology Association(AdvaMed).19 To hold other programs, companies must contract independent organizations. Speakers at CME programs should present balanced and objective views that are not influenced by the interests of the sponsoring drug companies.
The Department of Health and Human Services Office of Inspector General(OIG) has started to enforce these guidelines under its umbrella scrutiny of drug company kickbacks to physicians.20,21 Public focus on these issues is likely to grow. A front page article in the New York Times published on the day this article was completed was devoted to its investigation of drug company inducements to physicians.22
CME Provider Companies
Obviously, these trends place substantial stress on the efforts of pharmaceutical companies to educate physicians about their products. With the FDA and OIG increasing scrutiny of CME activities involving drug companies,the companies have engaged independent, third-party vendors to hold such events. This places an intermediary between the pharmaceutical corporations and the physicians or health professionals in the audience.23
Whether this arrangement involving third-party intermediaries actually facilitates objective and independent presentation in CME funded by drug companies is a very controversial issue.24 The mere separation of functions in the conduct of CME programs between pharmaceutical companies and third-party vendors offers little or no expectation of such independence. The vendors know full well that the drug companies are their clients, and their business with the companies is completely dependent on the companies' satisfaction with the programs provided. Given the clear conflict for CME vendors between independence in program planning and execution and dependence on drug company funding, the Alliance for Continuing Medical Education has proposed a radical revision in acceptable criteria for selecting speakers. It introduced a proposal last year, sanctioned by the Accreditation Council for Continuing Medical Education (ACCME), to ban medical speakers from programs if the speakers have ever accepted substantial honoraria or other support from pharmaceutical companies.25 The degree to which these standards should be applied is a matter of active discussion.26,27
The Coming Crisis in Diabetes Care CME
What appears to be a trend toward increasing ethics in CME may, in fact, be the seeds of a disaster in all health professional education. These understandable attempts to resolve apparent ethical conflicts in the present CME process offer unacceptable outcomes, with expectations that are unrealistic. In addition, health professionals who are actively involved in the process, either as CME presenters or participants, can already see unintended developments that are obnoxious and serve as discouragements to participate in the CME process at all.
There is an active, sub-rosa controversy among members of the Alliance for Continuing Medical Education about the practicability of the new ACCME guidelines.27 After hearing the criteria for the disqualification of speakers who have had previous active involvement with pharmaceutical companies, participants at the alliance's 29th annual meeting exclaimed, “We won't have any speakers left.”27 In addition, there is a real concern about whether all of these trends will discourage drug company funding of CME. It is unreasonable to expect any company, pharmaceutical or otherwise, to provide funding for events that offer them no clear benefit.
The changes that have occurred thus far, in response to the policy initiatives of ACCME, the OIG, and the FDA, are worrisome. With all of this external scrutiny, drug companies have clearly distinguished how the funds they provide for CME programs that are ACCME-accredited may be employed versus for other programs. This is true whether the other programs are directly sponsored by the drug company or by a third-party vendor. Speakers at ACCME-accredited programs have full latitude to discuss their professional opinions. Speakers at all other company-sponsored programs must adhere to those slides that have been approved by the pharmaceutical companies.
Companies have restricted what speakers at these other programs can discuss, in part to prevent the presentation of off-label uses of products. Given the increasing oversight of the FDA and OIG in this area, such restrictions are understandable. Because companies now require speakers to use slide sets provided by the companies, speakers cannot deviate from the content of these slide sets. As a result, most of these programs have become nothing more than infomercials for the products of the sponsoring company.
The result of these changes may be increasingly uninteresting and unimaginative programs. The enthusiastic application of the off-label restriction by the FDA forgets that important uses of many therapeutic agents are or previously have been off label. Examples include the use of metformin in the treatment of polycystic ovary syndrome28 and the use of angiotensin-converting enzyme inhibitors in the treatment of diabetic nephropathy in normotensive individuals.29
In addition, the PhRMA and AdvaMed guidelines have been used, in many circumstances, as justification for parsimonious or even hostile approaches by CME vendors toward medical participants in meetings. Examples include requirements that health professionals travel by inconvenient arrangements or at unreasonable times,24 or that the participants pay exorbitant amounts to allow their significant others to participate in the social events held during a meeting. These guidelines impose a standard of conduct on health professionals that is not imposed on interactions between pharmaceutical companies and anyone else, including elected officials, executives of managed care plans, pharmacy managers, or even the managers of health professional organizations. What these guidelines really do and do not require will be the subject of the “Business of Diabetes” article in the next issue of Clinical Diabetes.
Steven B. Leichter, MD, FACP, FACE, is co-director of the Columbus Research Foundation and president of Endocrine Consultants, PC, in Columbus,Ga., and is a professor of medicine at Mercer University School of medicine in Macon, Ga.