The current state on industry support of organized meetings

by Theodore C. Eickhoff, MD

Imagine, if you can, an annual meeting of the Infectious Diseases Society of America that is wholly devoid of industry funding, or even industry presence, save for those members or fellows of the society who are employed by industry. There would be no luxurious, sometimes garish, industry displays in the exhibit hall — only poster presentations. There would be no free goodies, no industry labeled pens, notepads, tote bags, or any of the other many give-aways, no free lattés or cappuccinos — not even free coffee, except as provided by the IDSA, with a hugely increased registration fee. What would such a meeting look like?

Except for the size of the meeting, it would look a lot like the IDSA meetings used to look!

IDSA’s history with industry

Since its inception in 1963, the IDSA has had an ambivalent and tortuous relationship with the pharmaceutical industry. This has been nicely summarized by Ed Kass in his 25-year history of the IDSA (Rev Infect Dis. 1988;10:1-169). Kass convinced 13 drug companies to contribute $250 each to help support the society’s organizational meeting in 1963. In return, the contributing companies were listed in the program and could send two representatives to the meeting. But, for that level of industry support, it is quite possible that the Society might never have gotten off the ground.

That arrangement persisted for the next 5 years. Subsequently, the support level was increased to $500. During the 1970s, the ambivalence of the society about pharmaceutical support was evident in discussions about whether the contributing companies would be listed in the program or not, and about changing the names of the two major awards given by the society: the Bristol Award and the Squibb Award.

Throughout the 1970s and 1980s, IDSA and ICAAC met in back-to-back sequence, permitting the IDSA to maintain its annual meeting free of industry support — save for the Bristol and Squibb awards. The Society did, however, receive funds from ICAAC on the grounds that IDSA brought many attendees to the ICAAC meetings. Furthermore, the coffers of the IDSA were substantially enriched by publication of company-sponsored symposia on one or another drug.

When the IDSA split its annual meetings away from ICAAC and began to meet independently, the financial requirements to support annual meetings came into sharp focus, and industry support began to be sought — and willingly provided. This dependency grew steadily since the split, and industry presence has been increasingly apparent each year.

Is there a quid pro quo?

Can this dependency continue to grow each year with little or no restraint? What message does all this industry largesse send to our trainees, patients and the public? Is there a quid pro quo?

Voices of caution are being increasingly heard, both from respected academic leaders and from organized medicine itself. All levels of medical education — undergraduate, postgraduate and continuing — have been concerned about this issue and are attempting to constrain or regulate it.

Jerome Kassirer, MD, an outspoken critic of industry support in medical education, has recently said there is indeed a quid pro quo, and that it is, very simply, a loss of professionalism. Medicine must maintain the integrity of medical knowledge and medical education; to the extent that it cannot or does not do so, we have lost our status as a profession, to the detriment of our patients.

Our oath and the trust that our patients place in us require that we hold ourselves aloof from the “commerce” of medicine. Kassirer suggests that medical professional societies need look no further than the lessons to be learned from the respected accounting firm Arthur Anderson. When serious conflicts of interest toppled this prestigious firm, the entire accounting profession suffered as a result. Similarly, if even one medical professional society is seen by the public as being more concerned for itself and its members than for its patients, all of medicine will suffer.

Goals for professional society

Kassirer has outlined three sets of goals for professional societies to maintain their professional integrity, together with the steps to be undertaken to accomplish each goal.

First, restore professionalism to the organization. This can be accomplished by appointing to office only those physicians who are free of financial conflicts of interest. Restore a more professional environment to the meeting ambience by restoring some sense of modesty to the displays, and phasing out industry-sponsored symposia. Management’s interest in industry support should be reined in.

Second, the integrity of medical information must be protected. Restricted grants should be rejected, and industry support accepted only if it is unencumbered. Journal editors must be free of financial conflicts of interest. Clinical practice guideline committee members must, to the extent possible, be free from the bias of financial conflicts — an issue of special significance to the IDSA.

Finally, financial arrangements with industry must be completely transparent and reviewed for possible quid pro quo’s by a committee of unconflicted society members. Sources, amounts and purposes of industry support should be publicly available on the society’s website. The Council of Medical Specialty Societies has recently released a similar set of recommendations.

Note that Kassirer does not advocate termination of all industry support; rather, he advocates placing defensible boundaries around it, although a number of respected academicians support such a goal. There are as yet no sources of noncommercial funds available to support continuing medical education, and there seems to be no likelihood such funding may be available in the foreseeable future.

Looking into the future, I know that the IDSA leadership is very much aware of and concerned about these issues. The toughest challenge for the Society is industry support for our annual meeting and other programmatic activities. At this time, there seems no way to forgo industry support and maintain the same level of educational activity that is presently done.

Eickhoff’s note: Some readers may be struck by the apparent incongruity of this column appearing in a publication supported by industry advertising. I do not think it is incongruous at all. Industry is as aware of these issues as are we. This is not an adversarial setting; common ground can be achieved as long as both industry and medical professional societies, eg, IDSA, are aware of and respectful of each others differing responsibilities, goals and allegiances.

by Nayiri Baljian, MA and Barry Eisenstein, MD

Cubist Pharmaceuticals

We cannot imagine a world in which there is no relationship between the pharmaceutical industry and medical societies, each with complementary sets of clinical thought the leaders and researchers. We will add to that mix of regulators, believing strongly that collaboration among all three entities is crucial for the development of life-saving pharmaceutical products. We dare say that if such a divided world were to exist, the infectious disease armamentarium would inevitably look much like it did in the pre-Penicillin era.

Pharmaceutical support

Let us dive more deeply into the idea of collaboration with a closer look at Kassirer’s viewpoint on pharmaceutical support of professional societies, which Dr. Eickhoff references. We agree with Kassirer that it is critical for medical professionals to “preserve and protect the integrity of medical knowledge.”

We disagree, however, that the pharmaceutical industry, comprised of thousands of medical professionals who are viable thought leaders with regard to the products produced, de facto distorts the integrity of medical knowledge and education. We acknowledge the business imperative that a for-profit company is ultimately obligated to its stakeholders and must thereby do what it can to increase the bottom line. (Similar concerns could be raised with the ethical issues surrounding for-profit hospitals or the increasing pressure on the “bottom line” in not-for-profit health care institutions that is turning the science of patient care into a numbers game).

This business imperative does not preclude the pharmaceutical industry from sharing in the mission of medical societies, as Kassirer describes, “to support research, improve care, advocate for patients, educate physicians, and foster communications.” Acknowledging past abuses, the pharmaceutical industry today in many ways embraces this mission as our own, if not explicitly stated. Even more important is the idea that these are not parallel missions, being executed by each party independently. Rather, the mission of the medical society, that of the pharmaceutical company, and that of the FDA are inherently intertwined.

Ten by 2020

Recently, the IDSA has put concerted effort into its 10 new antibiotics against significant bacterial pathogens by 2020 initiative. The pharmaceutical industry and the FDA are key collaborators in this initiative aimed at improving patient care — the initiative must be collaborative. We reflect on our own experiences with the development of daptomycin for injection (Cubicin, Cubist Pharmaceuticals) particularly the ways in which stakeholders aligned around the development of our landmark trial in patients infected with Staphylococcus aureus and right-sided infective endocarditis.

Colleagues from within Cubist joined forces with thought leaders (most of them members of the IDSA) and the FDA to design a trial that had essentially never been undertaken. In a similar vein, we highlight the recent work of the Foundation for the National Institutes of Health. In a series of workshops hosted during the spring and summer of 2010, representatives from the FDA, NIH, academia, clinical practice, and industry achieved consensus around guidelines to be proposed by the FDA for the development of clinical trials (including guidance around non-inferiority margins and endpoints for skin infection trials with ongoing work for community-acquired pneumonia trials).

Conflict of interest

With an emphasis on collaboration, we return to Dr. Eickhoff’s question of conflict of interest. With the most recent updates to the PhRMA Code (2007), member companies who voluntarily subscribe to the Code, no longer provide meals, gifts/product reminders, or other considerations to health care professionals as part of routine promotional activities. However, this is no longer an era of industry “goodies” and give-aways.

In like fashion, support for continuing medical education is highly regulated. It is important to note that a large portion of CME support is granted to medical societies. In the current era of industry compliance, it is expected and normative for industry to be “hands-off” when it comes to CME, such that companies cannot choose the speakers or what they say; companies can only provide unrestricted support to independent sponsors of CME events.

By regulation, CME programs are designed to be free of bias and present fair-and-balanced information. CME presentations are typically peer-reviewed and usually leave no room for product promotion. CME is typically not a component of a pharmaceutical marketing agenda, but rather a medical activity that is earnestly seen as a way to broaden clinical knowledge. The better informed clinicians are when it comes to the data, the more likely they are to make the right clinical decisions, whether or not that decision involves one of our products.

Moreover, we respect the various perspectives that CME provides to its learners. Cubist, focused on acute care products and specifically antimicrobials, primarily supports programs in the infectious disease space. A percentage of the programs we support in a given year are on the topic of antimicrobial stewardship and infection control. It would be difficult to argue that a program on infection control could translate into greater sales of antimicrobials. Rather, support of CME for clinicians promotes patient well-being and advances good clinical science in this country.

What about payments for consulting services and research grants between clinicians and industry? A real conflict lies here: On the one hand, it is in the best interest of patients when outside clinical experts collaborate with the pharmaceutical industry in product development; on the other hand, it is in the best interest of patients when some of these same experts, who understand the value and role of these commercial products, sit on guidelines committees that provide best usage advice for these therapeutic agents. We need to trust that physicians, who are fairly compensated for their consulting engagements, can continue to make ethical guidelines recommendations, make unbiased publications decisions, and deliver fair-and-balanced educational programs — despite their prior and even ongoing work with industry.

Recognizing the past abuses by the pharmaceutical industry require restoration of trust and mutual respect. We feel strongly that arguments about the undue and biased influence of industry have increasingly less weight, given present regulations around CME and gifts to physicians. At the same time, consulting and research arrangements with clinical experts who are compensated based on fair-market value are a necessary part of the drug development process.

Continued collaboration

To summarize, we quote Richard Epstein, who writes, “[A] strong populist sentiment holds that the profit motive always corrupts the operation of large and successful firms, so that their every action must be scrutinized under the maximum that what’s good for the drug company is bad for their customers and the population at large.”

Epstein goes on to repudiate this simplistic approach in his well-balanced analysis that remains appropriately cautious, calling for continued vigilance about overcoming conflict-of-interest in health care. Finally, we return to the notion that, through its ongoing investment in the discovery and development of new drugs, the pharmaceutical industry is a vested and credible partner in the advancement of medical science. We hope for continued collaboration with members of IDSA and others as we carry out our common mission together.

For more information:

• Council of Medical Specialty Societies Releases Voluntary Code for Interactions with For-Profit Health Sector. www.cmss.org/CodeRelease.aspx
• Institute of Medicine. Conflicts of Interest in Medical Research, Education and Practice. National Academies Press, Washington, DC. 2009.
• Kassirer, JP. Professional Societies and Industry Support; what is the quid pro quo? Perspectives in Biology and Medicine. 2007. 50:7-17.
• Kirkland KB. From Quid Pro Quo to Quid Pro Bono: Reshaping the Influence of Industry on Healthcare Epidemiologists. Clin Infect Dis. 2010. 50: 93-97.
• Morris l, Taitsman JK. The Agenda for Continuing Medical Education - Limiting Industry’s Influence. N Engl J Med. 2009. 361:25;2478-2482.
• Rothman DJ, McDonald WJ, Berkowitz CD, et al: Professional Medical Associations and Their Relationships With Industry. JAMA. 2009. 301:13;1367-1372.