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The Relationship of the Profession to the Health Product Industry - FAQ




Can physicians accept lunches for their staff or meals at meetings sponsored by the health products industry?

The Wisconsin Medical Society’s policy creates a bright line on the issue of accepting gifts from those who provide health products prescribed by physicians. The prohibition against accepting any gifts, including meals and other gifts of food, eases the burden of compliance, prevents possible biased decision making and avoids patient mistrust. To comply with the Society’s policy, a physician who has previously allowed drug company representatives to provide food to the physician’s staff should instruct the drug company representatives to immediately discontinue the practice of providing any food or other items to the physician and/or his or her staff.

When physicians attend meetings where free meals such as breakfasts, lunches or dinners are provided by members of the health products industry, physicians are encouraged to either refuse the meal or pay for the meal. When the physician writes a check for the cost of the meal, he or she might retain a copy of the cancelled check and make a notation of the date, time and place of the event for his or her own records. Physicians who attend conferences and other meetings can address the issue of paying for meals in advance by contacting the conference or meeting sponsor before the date of the event.


Does the Society intend to expel physicians who fail to comply with the policy on the acceptance of gifts?

The Wisconsin Medical Society develops policies through its House of Delegates and Board of Directors to shape and guide the decisions and actions of physicians, policymakers, legislators, the media and others. Policies such as ETH-004: The Relationship of the Profession to the Health Product Industry, are adopted after robust debate and careful deliberation. The Society believes that ETH-004 serves the best interests of medicine as well as the interests of patients. Therefore, the Society hopes that physicians will adopt it into their practices and encourage their colleagues to do so. The Society seeks to unite, rather than divide physicians, even on policies that may appear to be controversial. Therefore the Society has traditionally used its efforts to educate and encourage physicians to comply with Society policies rather than expel them. Although the Society’s Bylaws set forth certain circumstances in which expulsion is appropriate, a physician’s failure to adhere to a particular Society policy has generally not served as the basis for expulsion.


Will the Society’s policy impact a physician’s ability to distribute drug samples to low income patients? If so, are there any options other than drug samples to help low income patients receive the medications they need?

The Society’s policy recognizes that under some circumstances distributing drug samples might be appropriate, but physicians should limit the distribution of drug samples and if possible, replace that system with a system of vouchers for evidence-based drug choices. Working to achieve a better method of delivering low cost or free medications to low-income patients, such as through a voucher system, would promote the delivery of the most appropriate evidence-based drugs. In some instances, physicians might only have drug samples for costly drugs with less evidence of efficacy when compared against some of the lower cost, effective drugs on the market, including generic drugs. The Society’s policy places value on the opportunity to develop new ways to provide evidence-based medications to low-income patients, which in some cases might result in patients receiving more effective medications than a particular drug sample, for the patients’ specific condition. We encourage physicians to provide low income patients with information about prescription assistance programs such as the Partnership for Prescription Assistance that attempts to match eligible patients with programs that provide low cost or free medications. Information about the Partnership for Prescription Assistance is available on the organization’s Web site at https://www.pparx.org/Intro.php.


Can physicians continue to participate in medical conventions or conferences where drug representatives are displaying new drug information and giving away free merchandise such as pens, post-its, etc?

Yes, physicians are able to participate in medical conventions, conferences and other meetings where pharmaceutical representatives are displaying new drug information. Physicians could obtain helpful information by viewing displays and literature about various health products. However, physicians should refrain from accepting free merchandise such as pens, post-it notes or other items.


Does the Society’s policy create a double standard by failing to prevent pharmaceutical companies from placing advertisements in medical journals?

The sale of advertising space to members of the health products industry presents issues that are different from the issues that surround physicians’ acceptance of gifts. The first issue for medical journals is whether the sale of advertising space is based on fair market value, by charging pharmaceutical companies and other members of the health products industry the same rates as other companies or individuals who advertise in the journal. The use of the fair market value standard removes the potential of the medical journal from deriving a free benefit or gift from the health products industry. The second issue that medical journals must consider is whether certain pharmaceutical advertisements or the total number of pharmaceutical advertisements in a particular journal issue have appropriate educational value for the physician community, without improperly influencing prescribing habits or promoting prescriptions for medications that have limited scientific evidence that they improve patient outcomes. The Wisconsin Medical Journal has rarely sold advertising space to pharmaceutical companies. The Wisconsin Medical Journal’s Editorial Board recently reviewed its policies and practices and decided that such advertisements do not create undue influence to prescribe certain drugs or devices over other more appropriate evidence-based drugs or devices.


Does the Society’s policy prevent physicians, physical therapists and other providers of medical services from providing free lunches, cookies, candy and other snacks to physicians and members of their staff as a method of obtaining patient referrals through a “Lunch and Learn” model.

The use of the Lunch and Learn marketing model by physicians, physical therapists and other medical service providers involves the provision of gifts of food to physicians and members of their staff. The literal language of ETH-004 prohibits the acceptance of gifts from “those who provide health products prescribed by physicians, including the pharmaceutical and device industries.” The phrase “health products industry,” while not clearly defined in ETH-004, is commonly used to refer to industries that manufacture or sell products that a physician might prescribe such as pharmaceutical, device and medical equipment industries. When suggesting changes to ETH-004, the Council on Health Care Ethics suggested “health products industry” as a shorthand term for companies selling pharmaceuticals or medical devices.

Gifts to physicians from other physicians, physical therapists and other health care providers might fall outside the common understanding of the phrase “gifts from the health products industry.” However, the Society passed ETH-004 in part because of the potential for the receipt of gifts to influence decision making and in part to avoid the appearance that gifts, of any value, might influence medical decision making. The acceptance of gifts by physicians from physicians, physical therapists and others could create the appearance that the decision to refer patients to a particular physician, physical therapist or other health care provider is influenced by the gifts. The Society’s policy is one step in the direction of addressing concerns and perceptions about the acceptance of gifts.

The use of the Lunch and Learn model by physicians and others who do not fall within the literal language of ETH-004 presents an opportunity for continued dialogue on the overall issue of accepting gifts. Physicians may choose to extend the applicability of ETH-004 to health service providers, including other physicians, who give gifts as a means of generating patient referrals, irrespective of whether those individuals fall within the common understanding of the term “health products industry.”

The Society cannot assess the legal implications of the Lunch and Learn model on a physician’s practice, but notes that it could raise red flags as conduct potentially prohibited by the federal anti-kickback statute. While the meals likely have a nominal value and are likely consumed during the presentation, a violation of the anti-kickback statute could exist if an item of value (e.g. the meal) is offered or received to influence the referral of patients or services for which federal health care programs such as Medicare, Medicaid and Tricare might be billed. The Office of Inspector General, in its compliance guidance to pharmaceutical manufacturers stated:

Manufacturers, providers, and suppliers of health care products and services frequently cultivate relationships with physicians in a position to generate business for them through a variety of practices, including gifts, entertainment, and personal services compensation arrangements. These activities have a high potential for fraud and abuse and, historically, have generated a substantial number of anti-kickback convictions. There is no substantive difference between remuneration from a pharmaceutical manufacturer or from a durable medical equipment or other supplier – if the remuneration is intended to generate any federal health care business, it potentially violates the anti-kickback statute. (See Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, April 2003, page 28: http://oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf)

The Society recommends that physicians who give or receive gifts under the Lunch and Learn model resolve any potential legal concerns with their own counsel.


How can the pharmaceutical industry and other members of the health products industry tailor their programs to promote compliance with the Society’s policy?

Members of the health products industry could help Wisconsin physicians comply with ETH-004 by excluding free gifts, free meals and other items from industry sponsored programs. If meals and gifts remain part of a program or meeting, then program sponsors should provide participating physicians with information regarding the cost of the meal or the fair market value of gift items along with a clear and easy process that the physician can follow to pay for the meal or gift item. Members of the health products community should ensure that their oral and written communications encourage rather than discourage physicians’ compliance with ETH-004.


Do physicians risk creating a negative perception by accepting free meals or other gifts? If so, who is likely to hold the negative perception?

Over the past few years, various journals, newspapers and other publications have highlighted the practice of the health products industry providing meals, gifts and other items to physicians. The attention paid to the acceptance of gifts has created the perception that the acceptance of gifts affects physicians’ medical decision making, which could potentially cause harm to patients and contribute to high health care costs by increasing the cost of prescription drugs, devices and medical equipment. Public perception can affect the behavior of patients, regulators and others, even if the premise underlying the perception is questionable. The Wisconsin Attorney General’s office issued a press release on October 22, 2008, regarding its judgment against Pfizer in which it mentioned concerns about certain behavior, including “co-opting influential doctors with paid consultancies and lavish weekends at high end resorts.” The press release also mentioned Pfizer’s practice of “ghost writing” articles and studies, distributing drug samples to encourage off-label prescribing and using “mentorships” to pay physicians for spending time with Pfizer sales representatives. The Society believes that the Pfizer judgment and related press release is a signal that regulators are likely to scrutinize physicians’ acceptance of gifts from the health products industry in the future. The Society also believes that public perception about the impact of acceptance of gifts from the health products industry might motivate legislators to implement measures to mandate the reporting of gifts or legislatively ban the acceptance of gifts. In early 2008, the Massachusetts senate voted unanimously to pass a ban on the acceptance of gifts, which would have created criminal penalties for violations of the proposed ban. However, the Massachusetts house did not pass the ban; instead it required pharmaceutical companies to adopt a marketing code of conduct. However, the debate in Massachusetts has increased the focus of lawmakers across the country on the issue of physicians accepting gifts from the health products industry.

Physicians who comply with ETH-004 can reassure patients that their medical decision making is based on appropriate medical factors rather than any influence from the health products industry by posting signs containing the following language:

TO OUR PATIENTS

To uphold the highest standards of our Profession,
To ensure our advice is based solely on what’s best for you, and
To enable your highest level of trust in our advice,
We follow the recommendations of the Wisconsin Medical Society,
And accept no gifts from any provider of a product that we prescribe or recommend to you.


Does ETH-004 discourage physicians from working collaboratively with the health products industry?

Collaborative exchanges of information between physicians and members of the health products industry are essential to the development of new medications and other products to successfully treat patients and improve their quality of life. The acceptance of gifts should not be the focus of the important work that is shared by physicians and members of the health products industry. ETH-004 removes the distraction that the acceptance of gifts causes and refocuses the attention of the health care community, legislators, patients and regulators on the important contributions that physicians and members of the health products industry make toward evidence-based biomedical discoveries, product development and education.


Is there any evidence to support the public’s perception that accepting gifts could influence medical decision making?

Physicians endeavor to provide high quality health care to patients through evidence-based medicine. However, there are several studies that suggest that influence can occur at a subconscious level, despite a person’s integrity or high moral values. In the commentary, Everyone’s a Little Bit Biased (Even Physicians), published in JAMA, June 25, 2008, Vol. 299, No. 24, page 2893, the authors conclude that unintentional bias is a natural human phenomenon. A symposium on June 12, 2007, The Scientific Basis of Influence and Reciprocity: A Symposium, explored a number of issues that are imbedded in the acceptance of gifts, such as public perception, trust, the psychology of how the brain perceives influence and behavioral economics. The symposium articles suggest that removing the potential for bias resolves unintentional bias as well as the perception of bias that could impair physicians’ relationship with patients, legislators, regulators and others.

A study published in the September, 2008 Southern Medical Journal concluded that physicians with access to brand name samples prescribed generics significantly less often to uninsured patients than when they had no access to brand name samples. The study was described in the October 6, 2008 edition of the AMA News. According to the article:

The study appears to be the first to look at how samples affect doctors' prescribing for uninsured patients. The findings come amid increased scrutiny of many forms of industry-medicine relationships, from drugmakers’ funding of medical education and physician speakers to gifts such as pens and notepads.