16 November 2016

Pharma Payola

'All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving' by Dana Katz, Arthur L. Caplan and Jon F. Merz in (2010) 10(10) The American Journal of Bioethics 11-17 comments
Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated.
The authors state
In the 1980s the large cash payments and lavish gifts some physicians received from drug companies captured public attention (U.S. Senate. 1990). There was concern that physician integrity was falling victim to commercial influence in ways that were costly to the healthcare system in terms of both dollars and public trust. Congressional hearings on pharmaceutical promotion led the American Medical Association (AMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) to adopt voluntary guidelines prohibiting the exchange of cash payments and gifts valued over $100 (Department of Health and Human Services 1991). Under these guidelines inexpensive gifts such as pens and notepads were expressly allowed providing they “relate” to medical practice. The office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS), in a set of studies examining marketing practices, questioned the extent to which those guidelines were being enforced and suggested that allowing small gifts might be contrary to the public interest (DHHS 1991).
Numerous studies of pharmaceutical marketing practices were performed during the 1990s. These studies suggest that the pharmaceutical industry exercised considerable influence over physician prescribing practices and formulary composition (Wazana 2000). The $12 billion spent annually by the industry on gifts and payments to physicians drew attention from the DHHS OIG and a large-scale study of marketing practices was budgeted for 2002. The study was to examine whether all drug company gifts present an inherent conflict of interest or even a violation of federal antikickback legislation (DHHS 2001). However, it was subsequently deleted from the OIG's research agenda (Robert Brown, personal communication, 2003).
In 2001 the AMA and PhRMA responded to the government's renewed interest in gift-giving by launching a joint educational campaign. Nine large pharmaceutical companies contributed a total of $675,000, and the AMA contributed $50,000 plus staff time in an effort to remind physicians, medical students, and pharmaceutical sales representatives of the importance of following the 1990 guidelines (Okie 2001). During this time the American College of Physicians and the American Society of Internal Medicine issued a position paper that recognized the potential for small gifts to compromise clinical judgment but stopped short of calling for the practice to cease (Coyle 2002).
In May 2002 PhRMA issued a new, voluntary code for self-regulation of industry interactions with physicians. The code continues to allow for the exchange of gifts valued less than $100 but puts “items of minimal value” in their own category. Whereas gifts under $100 can be given only “on occasion” and must primarily benefit patients, gifts of minimal value, including calendars and stress dolls, should benefit medical practice and can be given with any frequency. Snacks and modest meals are permissible so long as they are consumed while listening to the sales pitch of a company representative (PhRMA 2002).
No studies have been conducted specifically on the effect of de minimis gifts on physician prescribing practices. This might be due in part to the presumption that the size or value of a gift correlates with its potential to influence the recipient. Thus the larger and more valuable the gift, the weightier are the ethical concerns raised about the industry's influence over physicians. Until recently de minimis gifts generated little moral or regulatory concern.
Today, groups such as Public Citizen (Tanner 2001), Physicians for a National Health Program (http://www.pnhp.org), American Medical Student Association (Romano 2002) and No Free Lunch (http://nofreelunch.org) oppose all industry gift-giving on the belief that the practice conflicts with the professional duties of physicians. The OIG has also issued draft compliance guidelines that suggest industry gift-giving might violate federal antikickback laws in that the gifts are given to influence prescriptions. From the government's perspective this is particularly problematic for patients receiving federal health coverage (DHHS 2002). ...
In calling for practical responses the authors comment
Given that small gift-giving can influence clinical judgment in ways that conflict with physicians’ fiduciary responsibilities, the question of how best to respond to the problem still remains. Changes in the standards of acceptable professional conduct and pharmaceutical marketing practices might be in order, ranging from disclosure of gift exchange to elimination of the practice altogether.
In June 2002 Vermont enacted legislation (Vt. Acts No. 127 [2001–2002]) that requires pharmaceutical companies to disclose gifts worth more than $25 to the state pharmacy board. According to “Review and Outlook: Green Mountain Drugs,” published in the Wall Street Journal, 20 June 2002, Wisconsin, New York, and Maine are considering similar legislation. If gifts of all sizes are disclosed to federal or state regulators, valuable research can be conducted to determine the extent to which gift acceptance is associated with physicians’ prescribing practices. Disclosure policies can also take the form of requiring physicians to inform patients receiving prescriptions that they have received gifts from the drug's manufacturer. Considering the extent to which physicians’ offices are adorned with drug company trinkets, it is likely that patients are already aware of the de minimis gifts physicians receive. What they might not know is that these inexpensive penlights and notepads might actually undermine physician objectivity in ways that clash with their own medical and financial interests. Full disclosure, therefore, could also require physicians to inform patients of this potential bias. Such disclosure, however, would not neutralize the bias, nor would it assist patients who have little choice but to rely on physicians’ judgments and little or no ability to combat the bias.
One obvious and compelling policy option in response to the evidence of the power of small gifts is to restrict or eliminate gift-giving or gift acceptance. Restrictions could take many forms, such as limiting the frequency of or settings for gift-giving, for example, to conferences or major holidays. Enforcement of restrictions or bans could take various forms, including FDA regulation or ties to state medical licensure through state antikickback and bribery laws. In light of the evidence that all gifts influence behavior, physicians and pharmaceutical firms could be sanctioned now for small gift exchange under current antikickback laws (Bulleit and Krause 1999). The federal government has already indicated that gift-giving practices may be criminalized because of the presumable effects on governmental drug expenditures (DHHS 2002).
On the other hand, some might argue that the regulation of gift-giving in medicine should be no stricter than it is in any other business context. In response we ask whether physicians aspire to be viewed more like corporate salespeople or like professionals beholden to the public trust. Most journalists are not permitted to accept gifts from information sources, and university professors are prohibited from accepting gifts from students before grades are issued . Judges, National Basketball Association referees, and Major League Baseball umpires are all prohibited from accepting gifts of any size for any occasion from anyone with an interest in the outcomes of their judgments. Similarly, medical professionals ought to step up to the plate. When acting as patient advocates and trusted sources of information, physicians should carry out their professional activities in a way that minimizes the intrusion of avoidable conflicting interests.
We note that psychology research suggests that any imposed restrictions on physicians’ professional behavior are likely to be ill-received and viewed as an affront to their personal integrity and professional freedom. Because people tend to desire freedoms more when faced with the threat of losing them (Worchell and Arnold 1973; Cialdini 1993), restrictions would not only irritate physicians who (over)value drug company gifts, but physicians who have historically been indifferent to them might find themselves valuing the gifts more. The exaggerated desire for restricted behavior increases when the restrictions apply to one group and not another (Cialdini 1993). Therefore, if physicians liken themselves to business professionals, restrictions on gift exchange would be viewed as unfair because medicine would seem the only sector of U.S. business prohibited from exchanging small gifts. However, regulations barring the use of marketing wares would not, in actuality, regulate physician practices but only the sales practices of the pharmaceutical industry. To our minds, a ban on industry gift-giving would be inherently fair in that it would put all firms, including generics, on a level playing field.
Nonetheless, we recognize that gift-giving is the foundation of human interaction. If it engenders valuable social obligations that are definitional of relationships such as friendship and camaraderie, then regulating the gift relationship might compromise desirable, arguably essential, social relations. Government regulations might indeed be too crude and too heavy-handed an approach for micromanaging the fine lines between geniality and commercial inducement. For example, company-sponsored gifts to physicians clearly fall within the purview of government interest because they are ostensibly given for commercial purposes. In contrast, a true gift (one that is not subsidized by a company) that is given to a physician by a sales representative with whom a preexisting, interpersonal relationship or friendship is shared (not merely a professional acquaintance or courtesy) should generally fall outside the purview of government interest and regulation. It is the gray area in between that presents challenges with respect to the government's ability to enforce restrictions on gift-giving while refraining from dictating the boundaries of social interaction.
We believe that as a general rule society ought not regulate the exchange of small tokens of courtesy in business or other social settings. Medicine, however, is different. Limits placed upon pharmaceutical companies’ use of marketing wares within this context would not be unfair but rather both appropriate and enforceable. The drug industry is highly regulated, and restrictions on marketing practices are already in place. If the distribution of marketing wares were prohibited, associated expenses would no longer be deductible as a cost of business, and the practices would cease.
The body of evidence reviewed above suggests that guidelines aimed at preserving professional objectivity by limiting the size of gifts physicians receive or companies distribute have thus far been shortsighted. The practice of small gift-giving occurs in an environment where physicians interact heavily with industry sales representatives, have their continuing-education courses funded by industry, receive information from industry-funded studies, are deluged with print advertising, and see patients targeted by direct-to-consumer advertising. In an environment in which industry plays such a prominent role, it might be difficult to determine, even with rigorous research methods, which industry tactics wield the most influence and impossible to say with confidence that if the practice of small gift-giving were to cease, prescribing practices would change.
That said, from a moral and regulatory perspective, policies that determine the acceptability of a gift according to its size are unsound. The power of gift-giving, both large and small, must be acknowledged if appropriate regulatory policies are to be created and enforced.