Drug Reps Off Campus! Promoting Professional Purity by Suppressing Commercial Speech

Over the years, “wide-spread criticism of the pharmaceuti­cal industry’s extravagant marketing prac­tices and some doctors’ undignified” behavior in accepting gifts has led states, organizations, industry, institutions, and now more recently the federal government to institute reforms designed better to limit industry influence on physicians. As Lance K. Stell, Ph.D. noted in an article in the Journal of Law, Medicine, & Ethics, the result from these policies has led some to “promote professional purity by suppressing commercial speech.”

 

In analyzing the impact of these policies, Dr. Stell pointed to a paper done by Troyen Brennan and his co-authors, which asserted that these policies were “doomed fundamentally” for three reasons:

–   Incorrect assumptions about the mechanism of industry influence and on myths about the efficacy of disclosure as an ethical disinfectant

–   Failed to pinpoint responsibility for monitoring com­pliance and enforcement

–   Overestimated physicians’ powers of self-control but underestimated their venality.

 

The weaknesses the Brennan group saw led them to predict that the medical profession’s conflicts with industry “would continue to jeopardize the medi­cal profession’s standing with the public and to pose chronic, serious threats to medical professionalism.” In response to this concern, several academic medical centers (AMCs) agreed with the Brennan groups proposals and as a result, instituted more aggressive reforms to address industry influence.  Some of the Brennan group proposals were an across-the-board reduction in phy­sicians’ on-campus exposure to the pharmaceutical industry’s commercial speech, including bans on: 

–   Industry detailers (“drug reps”)

–   Gifts of any kind;

–   Samples directly to physicians;

–   Pharmaceutical industry sponsoring CME event;

–   Industry funding for individual physician travel

–   Faculty (physician or researcher) service on industry speakers bureaus;

–   Ghostwriting

 

Dr. Stell argued however, that this “ethics-revival movement, undertaken in the name of “restoring” professional­ism, is misguided, creates counter-productive incen­tives, is based on faulty premises, and will fail the duty to prepare future physicians for constructive, ethical engagement with their commercial partners in health care.”

One of the issues that arose from the Brennan groups proposal is whether the “pharmaceutical industry really focus on inno­vative research in pursuit of life-saving interventions (productive, good), or is it primarily market-driven by greed and profiteering (wasteful, bad)?” 

For the Brennan group, because the pharmaceutical industry “omitted to mention marketing among the activities that promote patient welfare,” the industry is primarily driven by greed. This omission is “rhetorically advantageous for the Brennan group to “insinuate, without actually claiming or even implying, that promotional spending does not promote patient wel­fare.”

However, as Dr. Stell pointed out, “isn’t it obvious that an FDA-approved product can promote patient welfare only if prescribing doctors know about it, learn to use it prop­erly, and timely begin offering patients access to it?” For critics of industry-physician collaboration the answer might not be as obvious. One example that could help explain to them why industry must market physicians is a newly FDA-approved device.

Physicians and surgeons often must be shown (not merely told) how to use new devices safely. As Dr. Stell acknowledged, “someone with product-development experience (e.g., a consult­ing physician or surgeon) must do this.” Critics may think that this would jeopardize the line between educa­tion and product promotion. However, “showing a procedure-performing physician how to use a newly approved device, and helping her to become comfortable with it, will tend to promote both successful patient outcomes and product allegiance. Favorable clinical experience with the device will lead to her teaching her procedure-performing colleagues how to use it.” All of this, for an FDA-approved device that is found safe and effective, will improve patient outcomes.

The Brennan group however, ignores the obvious benefits the example above provides, and instead purports that “all industry-sponsored educational speech is camouflaged commercial speech, and should be discounted as sheer pro­paganda.” They “dismissively stigmatize as mere “product promotion,” industry-sponsored “how-to” demonstration seminars on campus.” This approach is problematic because “banning commercial speech on campus diminishes faculty incentive to avoid T1 errors (by continuously updat­ing their theoretical knowledge base) because the commercial-speech ban prohibits learning the clinical applications from tainted promotional sources.

 

As Dr. Stell recognized, “strict enforcement of the distinction between edu­cation and product promotion will pose an unhappy choice for AMC faculty who are committed to innovation and translational science,” especially if proposals such as the AAMC’s are approved, which ban all off-campus interactions that are banned on campus. This leaves physicians with three choices:

–   Adhere to the Brennan/AAMC marketing bans

–   Depart the medical center for an environment less devoted to the desultory task of maintaining a high wall of separation between educational and commercial speech;

–   Mutter in private with other disgruntled realists about being cut off from the cutting edge.

Physicians however should not be forced to make such decisions, at least not by the Brennan group’s reasoning, because there is a compelling interest in innovation. As Dr. Stell asserted, “translational science and putting patient safety first says that medi­cal centers must make an exception to allow device education (with inescapable promotional effects) on campus.” This exception is significant because “product demonstration promotes technical proficiency promotes familiarity promotes comfort promotes successful patient outcome promotes prod­uct loyalty. 

Because of this exception, the value of innovation and translational science “is in tension, if not at odds with, maintaining a bright line between educational speech (good) and commercial speech (unsavory).” However, as Dr. Stell noted, AMCs are not much different from industry. AMCs “tout their awards, their national rankings, their technology, the excellence of their nursing and medical staffs, their high rankings in patient satisfaction surveys, their celebrity-patient endorsements.” They use commercials to “educate, but they also are meant to be influential and promotional.” Medical center mar­keting departments evaluate these materials prior to “roll out” — the photos for gender and racial balance, and the wording and text-placement for “tone” and “impact.”

Through all of this advertising and marketing, Dr. Stell pointed out that “AMCs have no foot­note disclaimer disclosing unvarnished M&M (morbid­ity and mortality) statistics, or recounts the tragedies that are (and should be) embedded in every medical center’s institutional memory. On the contrary, these glossy commercials emphasize the positive.” While “there is nothing wrong with” that practice, attacking industry for the same thing is hypocritical.

Another significant impact of marketing restrictions is that “companies with products marketable by DTC advertising will have an incentive to emphasize such products even more. With promotional efforts in AMCs prohibited, all pharmaceutical companies will have an increased incentive to shift their R&D expenditures towards DTC marketable products. Highly likely, the distribution of R&D investments will be affected by restrictions on products that would be better mar­keted to physicians.” Restrictions on access of industry to AMCs will also “handicap companies less well known to academic physicians.”

 

One of the main problems with the Brennan group proposals is that there are no data to support, that commercial relationships with drug and device makers poses a great challenge to physicians’ commitment to putting the interest of patients first. As Dr. Stell noted, “no study has compared industry’s commercial influence with the influence of reimburse­ment models on physician decision making using patient outcome as a measure.” He further recognized that the “Wazana’s review of the industry-influence literature, on which the Bren­nan group relies, while finding mostly negative effects of physician-industry interactions and only one posi­tive (“improved ability to identify the treatment for complicated illnesses”), states bluntly, “no study used patient outcome measures.”

This leaves Dr. Stell asking, “If none of the studies she reviewed used patient out­come measures, what basis is there for claiming that physician interactions with industry cause patient harm?”

Conflict of Interest

Part of the reason why the proposals from the Brennan group and other critics of industry-physician collaboration are problematic is because they improperly define conflict of interest. The Brennan group defines “conflicts of interest to occur when physicians have motives or are in situations for which reasonable observers could conclude that the moral requirements of the physician’s roles are or will be compromised.”

However, as Dr. Stell recognized, “a person’s motives are unobservable. Motives are attributed, based on evidence of some sort. The Bren­nan group fails to specify the standard of evidence required for making an objectively reasonable attribu­tion of a preponderant, malignant, role-compromising motive.”

Another problem with this definition is that it measures such motives from a “reasonable observer” perspective, or that of the layperson rather than the expert or professional. The Brennan group chose to use this viewpoint because the “medical profession’s standing rests on pub­lic trust,” and because “physicians differ about what they consider a conflict.” In other words, the Brennan group thinks that physicians’ own relationships with industry preclude them from making judgments about COIs.

Interestingly, using the public perspective, as the Brennan group proposes, shows that the public trusts physicians. In fact, “in four recent polls conducted between 1998 and 2006, The Harris Poll consistently found physicians ranking at the top or near the top for trustworthiness. In 2006, they ranked first, with 85% of adults agreeing that doctors generally can be trusted to tell the truth.” A 2005 national survey by Research!America found that 95% of respondents think that government, universi­ties, and the pharmaceutical industry should work together to develop new treatments. Therefore, the Brennan groups assertion that there is “an erosion of public confidence in physicians is very hard to document.”

Despite this evidence, the Brennan group goes on to argue that disclosure of physician-industry relationships is still not enough. While “egregious abuses have occurred in the past,” complete prohibition is not the answer because “rela­tionships between the medical profes­sion and the pharmaceutical industry have generated overwhelmingly posi­tive benefits on an unprecedented scale — advancing scientific knowledge, enriching drug and device makers and their stockholders, vastly expanding the treatment and diagnostic armamentarium, but mostly importantly to the advantage of patients.”

Although safeguards certainly need to be in place, Dr. Stell pointed to a paper from Dr. Thomas P. Stossel, which noted that “zealousness to make impossible a recurrence of well-vetted abuses creates an insidious, but serious over-deterrence risk that threatens and disadvantages everyone.” For Dr. Stell, closing AMCs from industry “is not an educational philosophy for professional engagement with the pharmaceutical industry.”

What is puzzling to him about those who want complete bans on industry from AMCs is best explained through the gift-exchange. Dr. Stell noted that “it remains to be explained why the psychological law of reciprocation” would compel physicians to return large-scale good acts in the form of prescription writing for the product manufactured by the drug reps employer, when all the physician receives is pens, pads, and pizza (assuming the physician perceives those as “gifts”).

It is also puzzles Dr. Stell “why doc­tors’ supposed “entitlement mentality” that explains gift-acceptance doesn’t actually cut off reciprocation rather than prompt it. Moral logic says receiving unde­served gratuities should trigger reciprocation, but with respect to gifts to which one is only entitled after all, moral logic prescribes “thank you,” not reciprocation.”

In the end, Dr. Stell recommends that instead of a complete ban on industry, AMCs should bring on campus former drug reps to give resident conferences disclosing how they were trained, and the compliance tricks they perfected and used successfully. Dr. Stell acknowledges that since physicians are the target-consumers of drug rep marketing, “if the informa­tion offered to physicians by industry is objectionably biased, its educational quality will not improve until physicians demand better.”

This way, AMCs can better train the next generation to learn and teach good cognitively active self-defense techniques. This is important because “physicians practice in a commercial envi­ronment, and they owe it to their patients who see DTC ads and other forms of drug marketing, “to critically engage profession-tar­geted marketing in the medical center.”