Industry and the physician: An evolving set of rules

In the seventh report from the OSN Section Editor Summit, Regulatory/Legislative Section Editor Alan E. Reider, JD, discusses the changing relationship between industry and physicians.

Issue: September 15, 2007

A note from the editors:

Ocular Surgery News convened its annual Section Editor Summit in February. In this seventh installment of reports from the summit, Regulatory/Legislative Section Editor Alan E. Reider, JD, of the Washington, D.C.-based law firm Arent Fox, discusses new rules and standards that govern how the pharmaceutical and device industries interact with physicians. The following is a summary of his remarks.

The relationship between pharmaceutical and device industries and physicians has been generating increased scrutiny over the past year or so. We are all watching closely to see what, if any, dramatic changes are about to take place.

The Journal of the American Medical Association published an article in January 2006 entitled, “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers.”

Alan E. Reider

The article stated that “Physicians’ commitment to altruism, putting the interest of the patients first, scientific integrity, and an absence of bias in medical decision-making now regularly come up against financial conflicts of interest. Arguably, the most challenging and extensive of these conflicts emanate from relationships between physicians and pharmaceutical companies and medical device manufacturers.”

The abstract of the article stated that, while physician groups, the manufacturers and the federal government have instituted self-regulation of marketing, “research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients. More stringent regulation is necessary, including the elimination or modification of common practices related to small gifts, pharmaceutical samples, continuing medical education, funds for physician travel, speakers’ bureaus, ghostwriting and consulting, and research contacts.”

Having worked on these issues for many years, I can attest that these goals represent the Holy Grail.

The article goes on to identify the “hit list” of conflicts of interest. These include gifts, meals, payment for attendance at meetings, payment for time spent attending meetings, payment for travel, payments for participation in speakers’ bureaus, provision of ghostwriting services, pharmaceutical samples, grants for research projects, payment for consulting relationships, as well as virtually all of the contractual relationships that exist between pharmaceutical companies or medical device companies and physicians.

The recommendations that stem from this article are as follows:

All “gifting” from drug and medical device companies to the physicians should be prohibited. This term includes gifts, free meals, payment for time traveled to or time at meetings, and payment for participation in online continuing medical education activities.
The direct provision of pharmaceutical samples to physicians should be prohibited.

The article itself was signed by a dozen physicians, all in academic medicine, suggesting that the academic medical centers should be the focal point of the recommended changes.

Swift response

The article was published in January of last year, and there has been a response from numerous sectors. Effective Jan. 1, 2007, Henry Ford Health System declared that all vendors must complete a compliance training and certification program before they may enter the building for a pre-scheduled appointment.

The University of California enacted a new policy that bans vendor gifts to individuals, free samples, supplies and equipment designated for an individual physician. Donations may be made to clinical departments or medical schools.

Yale, Stanford and the University of Pennsylvania also have enacted similar types of programs. But it does not end there, because as of Feb. 12 of this year we also have an initiative called the Prescription Project, supported by a $6 million grant from the Pew Charitable Trusts. The 2-year initiative was the brain child of Community Catalysts, a Boston-based health care advocacy organization, in partnership with the non-profit group Institute of Medicine as a Profession.

The Prescription Project now has $6 million to perform a study of potential abuses in this area and to develop new policies to present to the government, medical societies and academia. The goal is to effect a wholesale transition in the way the medical device and pharmaceutical industries do business with the physician community by documenting the scope of the problem and its impact on health care quality and costs.

In addition, the project aims to partner with leading academic medical centers, physician organizations, public and private health plans, consumer organizations and policy makers to assist medical centers and professional societies in adopting a wide range of policy reforms and initiatives.

So apparently there is some momentum in the public sector driving these changes, as opposed to an isolated response by a few of the nation’s leading medical centers.

Federal enforcement

I turn to a comment that was made earlier this year by a former Inspector General official who is totally independent of this development. He said that 2007 would result in increased enforcement activity within the medical device, pharmaceutical and physician communities, particularly with respect to the relationship between pharmaceutical and medical device industries and physicians. That prediction, he said, included prosecution of physicians as well as companies, in order to get the attention of those in the medical community who believe they are too small a target.

Now, the combined effect of the JAMA article, the academic medical centers’ response and the Prescription Project could lead to higher standards throughout the medical profession. This certainly could encourage government enforcers who would view this as an acknowledgement by the medical community that there are problems that need to be addressed.

All of this, in addition to the transition of Congress to a Democratic majority, could result in additional legislation as well. So the word of warning is to be careful out there.

It’s a tough field.

For more information:

Alan E. Reider, JD, can be reached at Arent Fox LLP, 1050 Connecticut Ave., NW, Washington, DC 20036; 202-857-6462; fax: 202-857-6395; e-mail: reider.alan@arentfox.com.