Physicians and Pharmaceutical Company Representatives
Authors: John W. Hafner, MD, MPH, FACEP, Assistant Clinical Professor of Surgery Emergency Medicine, University of Illinois College of Medicine at Peoria, Department of Emergency Medicine, OSF Saint Francis Medical Center; and Timothy Raines, MD, Assistant, Department of Surgery, University of Illinois College of Medicine at Peoria, Department of Emergency Medicine, OSF Saint Francis Medical Center.
Peer Reviewer: Jonathan Glauser, MD, FACEP, Department of Emergency Medicine, Cleveland Clinic, Cleveland, OH.
It appears that it is going to be one of those days. Working a busy shift on a typical Monday, you have already diagnosed and treated patients with diffuse and nonspecific abdominal pain, chest pain, weakness/dizziness and resuscitated a full arrest all before noon on the early a.m. shift. The charge nurse informs you that one of the loyal drug reps has stopped by the ED and brought a catered lunch for you and the staff in the back break room and would like a moment of your time. A clerk smiles and chimes in "be sure and pick up some pens and sticky pads for the front desk." Drawn by the prospect of a quick bite between patients on a relentless and demanding shift, you head back to the break room. The drug rep is a friendly, well-dressed and articulate professional, and at first seems mostly unconcerned about the product splashed all over the table in high gloss pamphlets. As you begin to help yourself to the food the drug rep introduces the new drug that appears to be an improved addition to the "standard" medications in its class. The rep discusses its improved palatability and dosing schedule, as well as a higher tissue concentration compared to its competitor. He seems to know how much you value evidence-based medicine and hands you a copy of an article detailing the drug's benefit in a recent clinical study. Impressed, you begin to take notice of the drug and look at the pamphlets in greater detail. The representative was also wondering if you like to play golf and "ever get away from the hospital" as he is sponsoring a small golf outing at a local country club for physicians that will include CME credits. Casually, he mentions that this drug is having some difficulty getting on the hospital's formulary, and that since the pharmaceutical and therapeutics committee is chaired by your emergency department director, you might be able to put in a good word for it.
Although this scenario may seem overreaching in its blatant pandering, it is actually a real life interaction that I experienced just prior to the enactment of the Pharmaceutical Research and Manufacturers of America (PhRMA) pharmaceutical representative physician interaction guidelines in 2002. Much has changed in the physician-pharmaceutical industry relationship since the enactment of stricter guidelines, but much has not. The pharmaceutical industry represents a legitimate facet of the American healthcare system, and much of the healthcare innovations we currently employ have been a result of private efforts. While it is important to recognize the accomplishments of the industry, it is also important for the physician to recognize the pitfalls. In this issue of Emergency Medicine Specialty Reports, we will explore the pharmaceutical industry and its contact with the individual physician. Physician and industry perspectives as well as the government and other regulatory bodies will be discussed in order to bring national debates to the individual level.
Many staff emergency physicians and resident physicians interact with pharmaceutical representatives on a regular basis. Usually the representatives bring information on their company's drugs as well as food that any hard-working, typically hungry emergency physician appreciates. The pens and other gifts representatives distribute may be appreciated, and they seemingly ask for nothing in return but a moment of the physician's time to speak about their product. It seems a fairly harmless interaction, with the emergency physician then returning to the daily grind in their busy emergency department. Many emergency physicians may feel that this contact is so brief that anything the representative says could not possibly affect their scope of practice in a meaningful way. Or does it? Emergency physicians should be asking themselves why pharmaceutical representatives, with the limited exposure to physicians during their busy ED shifts, continue to show up in their departments. One might envision financially savvy pharmaceutical companies losing money by paying highly trained employees to drive to various hospitals, coordinate a catered lunch for the physicians and staff, and deliver a limited presentation to an often disinterested audience. Why would arguably the most successful business industry in the world continue a marketing strategy that seems to be so ineffective? There has been much debate about how these visits and various other industry-related activities affect prescribing practices.
The relationship between physicians and the pharmaceutical industry can be viewed as a beneficial symbiosis of two components of the healthcare system bringing the latest innovations in treatments to patient care, or avaricious physicians willingly prescribing drugs from companies that offer them generous compensation for using their products. There has been increasing controversy regarding the relationship of physicians and pharmaceutical representatives for what exactly is considered an ethically acceptable or unacceptable interaction. The controversy stems from industry's contact with the holiest covenant in medicine the physician-patient relationship. Sometimes the industry-physician interaction can result in a clear conflict of interest. A conflict of interest is a discrepancy between the personal interests and the professional responsibilities of a person in a position of trust.1 This conflict of interest between the physician and industry can in some cases lead to detrimental effects on patient care, the medical profession in general, and violations of federal law. In fact, in some instances, the government has begun prosecuting pharmaceutical companies and physicians who violate these laws even though there was potential benefit to the individual patient. In 2004, after an extended investigation, Pfizer settled with the federal government for $430 million in fines and penalties for promoting its drug gabapentin (Neurontin) using lavish resort trips and hefty physician speaking and prescribing fees.2 One year later Lincare agreed to a $10 million settlement with the federal government for allegedly bribing physicians with sporting event tickets, fishing trips, golf outings, gift certificates, and office and medical equipment.2
Other times the industry-physician interaction appears to be much more harmless and is often tied to legitimate sponsored medical education. These industry-physician exchanges are typically addressed by the medical governing bodies of particular specialties and an honor system is often employed that is founded on the assumption of the professionalism and beneficence of physicians for their patients. Unfortunately, not all physicians have adhered to the established guidelines, resulting in increasingly stringent criteria put forth by individual medical specialties in the face of potentially augmented federal regulations. Several physician-pharmaceutical company indiscretions earlier in this decade led to successful prosecutions that left both parties reeling and resulted in sweeping changes of the guidelines that were already in place. Many pharmaceutical companies themselves have even instituted an improved set of guidelines relating to their representatives' interactions with physicians, also in part due to the threat of increased federal regulation. At the center of the interaction is an often uneasy partnership: pharmaceutical companies using the effective marketing strategy of visiting physicians, promoting their products, and providing gifts to increase sales; and time- and resource-limited physicians attempting to treat their patients using the latest standard-of-care pharmaceutical products.
The Physician Perspective
Most physicians feel that they can interact with the pharmaceutical industry even accept gifts and still remain immune to specific influences. Physicians are intelligent scientific professionals who have been trained to make rational decisions about proper therapies for patients without being affected by a modest lunch or pen. One review found that most physicians deny that gifts could influence their behavior, and that most physicians are equivocal about the appropriateness of gifts from pharmaceutical representatives.3 Physicians made distinctions about the ethical appropriateness that was reflected by the value of the gift, the type of gift, and the extent to which an activity conveys potential biased information.3 Surveys reveal that physicians view small-value gifts as ethically more acceptable than larger valued gifts, and letters to medical journals assert the opinion that small gifts to physicians do not affect physician judgment toward a product.4
If physicians were able to maintain objectivity toward gifts, there would be no need for guidelines. Unfortunately it appears that physicians are not as objective as they believe themselves to be. Many physicians did not seem troubled by gifts and activities that are considered problematic by professional organizations such as the American Medical Association (AMA) and American College of Physicians (ACP).3 One study documented a group of psychiatrists attending a grand rounds presentation whose speaker was sponsored by the manufacturer of quetiapine. Prior to the grand rounds presentation, two prescriptions were written for the drug, and 17 prescriptions were written afterward.5 This study is consistent with other results showing that general practitioners who were visited more frequently by drug representatives were more likely to express views that led to unnecessary prescribing patterns.6 Social science research has shown that even when individuals try to be objective during sales presentations, their judgment is subject to an unconscious and unintentional self-serving bias.4
While individual physicians often believe their judgment is immune from influence, they do not feel the same of their colleagues. A survey of medical students showed that significantly fewer students believed they would be influenced by gifts or food than believed that their colleagues would be influenced (31% vs. 42%, respectively).7 A medical resident study was even more extreme, with 61% of respondents stating that promotions did not influence their practice, and only 16% believing the same about their colleagues.8
Different medical practices and residency programs deal with the issue of pharmaceutical representatives in different ways. Some utilize clear-cut guidelines, while others have limited or no guidelines. A study comparing two medicine residency programs in Canada, one restricting access to drug representatives and one allowing access, reveals that industry contact during training does create influence. Those residency program graduates who were visited by representatives with unrestricted access during training reported more pharmaceutical representative contact and an increased perceived benefit of the information provided.9 The Board of the Council of Emergency Medicine Residency Directors (CORD) requested and approved a member survey regarding their beliefs and practices relating to industry sponsorship of speakers, social events, drug samples, travel to conferences, and the educational value of marketing representatives. Eight-five percent of EM program directors responded (106 CORD members) and the majority (72%) indicated never or rarely allowing unrestricted access to residents at work. Only 52% of directors never or rarely allowed representatives to give residents drug samples at work, and only 46% never or rarely allowed representatives to teach residents. In addition, two-thirds of program directors desired CORD guidelines regarding interaction with pharmaceutical industry.10
The Pharmaceutical Industry Perspective
Pharmaceutical companies are in a unique position of being a for-profit business providing products that assist in improving the length and quality of life. These companies spend on average more than $800 million to develop and test their products and bring them to market, including expenditures on failed projects and the value of forgone alternative investments.11 Since these companies typically have only about 8-10 years of patent life on an innovative new drug before the drug becomes available as a generic, it is necessary to market the drug aggressively to recoup costs and generate income for future products. The medium through which pharmaceutical companies recuperate this income is the physician-based prescriptions. Collectively the pharmaceutical industry spends a substantial portion of its operating budget promoting its products, and the majority of this money is spent on pharmaceutical representative interactions with physicians. Sales force personnel account for the largest part of promotional spending, followed by direct-to-consumer advertising.12 In 2000, there were 78,840 pharmaceutical representatives in the field, or one pharmaceutical representative for every 11 practicing physicians. Companies spent $431 million sending representatives to doctors' offices and $52 million more on hospital visits. The number of representatives nearly doubled between 1996 and 2000, selling pharmaceuticals to nearly 900,000 physicians in the United States.13 In 2001, 84% of pharmaceutical marketing was directed toward physicians.10
There has been so much negative publicity directed toward the pharmaceutical industry and escalating prescription drug costs that the Congressional Budget Office performed a study in 2006 to evaluate pharmaceutical company spending and whether the prices of prescriptions were justified.12 Some drug companies have sought to increase goodwill by subsidizing these medication costs and offering free drug samples that physicians can offer to patients. The pharmaceutical industry is also involved in offsetting the costs of continuing medical education (CME) conferences that at times might be difficult to produce or for some physicians to even attend. Since a number of these credits are required each year, the pharmaceutical industry is assisting in a component of education that is already mandatory.
Industry supported conferences, seminars, and symposia are helping physicians to provide the best, most appropriate, and most up-to-date health care to their patients.14 The Accreditation Council for Continuing Medical Education (ACCME) showed in 1999 that industry support represented almost half of the $1.1 billion spent on CME.14 It also states ACCME standards require that an accredited provider, such as a teaching institution, is responsible for the content, quality, and scientific integrity of all CME activities certified for credit.
Concerns for Interactions between Industry and Physicians
Some feel that even a limited role by a for-profit industry involved in the education of a scientific, objective, and beneficent field compromises the integrity of the physician-patient relationship. It has been noted that, with the approval of CME providers, pharmaceutical companies sometimes may prepare teaching slides and curriculum materials, and then compile lists of possible speakers and indirectly pay them.15 This statement is concerning, as is the recent growth of the Medical Education and Communication Companies (MECC) industry. MECCs are for-profit companies that compile educational programs to be presented in hospital grand rounds and CME presentations, and provide teaching materials for physicians.15 Many of these MECCs are accredited by the CME approving bodies, and can take full accountability for sponsoring their own CME programs. The problem becomes apparent when the support from these for-profit companies originates from the pharmaceutical industry.15 This practice becomes suspicious and appears to be a way to skirt the ACCME policies in place to prevent product promotion.
As for the pharmaceutical representatives who visit hospitals and offices, studies have shown that they are not always forthcoming about their products in relation to other competing medications. It has been noted that 11% of statements made by multiple representatives speaking at 13 different presentations contradicted information readily available to them, and all inaccurate statement were favorable to the promoted drug.16 There have been concerns with "preceptorships," in which a pharmaceutical representative spends a day shadowing the physician and seeing patients as "an educational experience," in which the physician receives an honorarium from the drug company in return.17 This practice not only violates the patient-physician relationship, but also introduces a non-medical person into the room with the physician and patient, possibly violating privacy and HIPAA (Health Insurance Portability and Accountability Act) regulations. There is also increased concern from the federal government that gifts from the pharmaceutical industry could increase the cost of government healthcare programs such as Medicare and Medicaid.18 In an effort to regulate costs, governments have been increasing their presence in issues relating to physicians and the pharmaceutical industry in this country and throughout the world. In the Netherlands, for example, acceptance of substantial hospitality from the pharmaceutical industry could result in criminal prosecution.19
The year 2001 created a ripple effect that resulted in significant changes in the guidelines for how the pharmaceutical industry and physicians interact. The AMA, ACP, ACCME, as well as the pharmaceutical industry counterpart the Pharmaceutical Research and Manufacturers of America (PhRMA) overhauled their associated guidelines for one simple reason to remain free from federal government regulation. In the past, these relationships have relied on the physician's conscience in these matters, but multiple concerns have brought this relationship to the attention of government officials. One of the key reasons is that the Medicare program has adopted a prescription drug benefit.20 The government is interested in any conflicts of interest that may increase the expenditure for prescription medications. In addition the body of federal law dealing with "fraud and abuse" has expanded to the point where pharmaceutical companies and physicians involved in questionable marketing practices can now be prosecuted.
Anti-kickback legislation was instituted in 1972 that was created to protect Medicare and Medicaid from inappropriate expenditures and use of service.20 It was initially used for clearly blatant industry violations, but since the early 1990s in situations where there is a partially lawful purpose in the relationship, a physician may still be prosecuted when there is also a clear unlawful purpose to the act.20 Another law increasingly used by federal prosecutors is the False Claims Act that imposes civil liability on those who knowingly submit fraudulent claim or payment to the federal government.21 Violations can result in fines from $5000 to $10,000 per claim plus three times the damages incurred by the government.21
The first major case where the anti-kickback and false claims laws were applied to physician and pharmaceutical company interactions was a class action lawsuit involving leuprolide acetate (Lupron). The federal government began investigating the marketing relationship of Takeda Chemical Industries and Abbott Laboratories (TAP) pharmaceuticals with various clinical urologists for the treatment of prostate cancer with the drug leuprolide. It was found the TAP encouraged urologists to bill Medicare at the average wholesale price for leuprolide, which the urologists received free or at discounted prices.20 It was found that the company employed several physicians as "consultants" without requesting any specific or significant services in return. TAP was required to pay $290 million in criminal fines plus $585 million in civil penalties, addressing practices that had been delegated prior to this time as ethical oversight.20 This successful prosecution led to other cases of similar pharmaceutical company practices, many of which were also successfully prosecuted. With the government setting its sights on regulating physician-pharmaceutical interactions, pharmaceutical and physician governing bodies revised their own guidelines to stem potential litigation.
Governing Bodies and Physician-Pharmaceutical Company Regulations
The ACGME created a set of guidelines to which CORD refers as their standard for interactions between physicians and pharmaceutical representatives released in 2002.22 This set of guidelines, known as "The White Paper," was developed not only because of concern for individual physician relationships with the pharmaceutical industry, but also due to the learned behavior of residents observing the attendings' interaction with these representatives.23 One of the six core competencies a resident must master during residency is professionalism, and this competency addresses the heart of the physician-pharmaceutical representative relationship. There are three principles that promote professionalism in programs and sponsoring institutions with regard to relationships with the pharmaceutical industry. (See Table 1.)
Table 1. Principles Promoting Professionalism in Residency in Regard to the Pharmaceutical Industry
The most updated AMA guidelines, revised in 2005, clarify what is ethically acceptable from the pharmaceutical industry in light of the increased policing of the physician-pharmaceutical relationship by the government. These guidelines now detail the specific kinds of gifts and honoraria that may be allowed, hoping to clarify some of the gray zones previously present. They even address funding for educational conferences sponsored by pharmaceutical companies and the selection process for residents who plan to attend them. (See Table 2.)
Table 2. AMA Guidelines Regarding Physician-Pharmaceutical Interactions
In emergency medicine, the American College of Emergency Physician's (ACEP) guidelines are simple, but somewhat vague. Regarding physician gifts, emergency physicians should only accept gifts of minimal value that benefit patients or serve an educational function only. They should also be willing to disclose all gifts received from biomedical companies. For educational conferences, ACEP's position is similar to the AMA guidelines, requiring participating physicians not to accept subsidies directly from pharmaceutical companies for conference, travel, or lodging. Faculty at conferences may accept fair compensation in regard to travel, lodging, and meals for time and service.22 The Society of Academic Emergency Medicine (SAEM) has guidelines regarding commercial support of SAEM activities,24 but no specific guidelines or policy regarding individual physician interactions with pharmaceutical companies.
The Department of Health and Human Services, Office of Inspector General, has developed a government policy aimed at reducing fraud and abuse in federal health care programs that was introduced in 2002. It explicitly states "this guide is not a compliance program. Rather it is a set of guidelines that pharmaceutical manufacturers should consider when developing and implementing a compliance program or evaluating an existing one."25 The first element of the seven minimum recommended elements relates directly to physicians, stating that "the development and distribution of written standards of conduct, as well as written policies, procedures, and protocols that verbalize the company's commitment to compliance and address specific areas of potential fraud and abuse, such as ... sales and marketing practices." To avoid increased federal regulation, the pharmaceutical industry quickly complied.
The pharmaceutical industry collectively developed a uniform set of guidelines addressing their representatives' interaction with physicians in 2002. The Pharmaceutical Research and Manufacturers of America (PhRMA) guideline highlights informal presentations by representatives. These presentations include modest meals as determined by local standards and occur in a venue and manner conducive to informational communication that provides scientific or educational value. Also addressed are professional meetings, where financial support will be given to the conferences' sponsors to offset the cost of those attending. When pharmaceutical companies underwrite conferences or meetings other than their own, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the organizers of the conferences or meetings in accordance with their guidelines. Pharmaceutical companies may provide financial support for meals to the CME conference provider as well as offer an additional reception in line with guidelines established by the conference provider, but time spent at these activities clearly must be subordinate to time spent at the educational activity. As far as practice and educational-related items, the cost of these items is not to exceed $100, and no items for personal use should be offered. It also states that no gift should be offered in a manner or on condition that would interfere with the independence of the physician's prescribing practices.26
Physicians' overarching and primary responsibility is to their individual patients, while the pharmaceutical industry's accountability is maintaining a reasonable profit for their shareholders. The pharmaceutical industry is at its core a business, and it cannot be expected to act on the patient's behalf as its primary motivation. This creates a conflict of interest for the physician. Conflicts of interests are "a set of conditions in which professional judgment concerning a primary interest (such as patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)."27 Even the free drug samples that appear as beneficial gifts for patients often lead to physician prescribing pattern changes that ultimately profit the pharmaceutical companies. Research has shown that once a patient finishes a supply of free medication, the physician tends to write a prescription for the same brand, resulting in higher patient costs.26 Although many new drugs today are "me-too drugs" (drugs in a similar pharmacologic class that have similar mechanisms of action but are made by a separate company), pharmaceutical companies are an important component of the healthcare industry because they develop drugs that advance medical care and assist physicians in better treating their patients.
On an individual physician level, research shows that basically any gift will bias a physician. The guidelines set in place by most of the professional organizations refer to inexpensive gifts for office use, low-cost educational or patient care gifts, and modest hospitality (reception with food and drink) that is connected with a legitimate educational program as acceptable. Those "acceptable gifts" can still lead to increased formulary expenses for hospitals. Two studies identified risk factors for increased requests for formulary additions of a drug (most of the formulary addition requests representing drugs felt to be of "little or no advantage" over existing formulary drugs): interaction with pharmaceutical representatives; receiving industry-sponsored meals, conference, or travel subsidy; accepting an industry-paid honorarium to speak at an event, and industry-sponsored research funding.30 Similarly stated, there are 3 interactions with physicians that influence prescribing behavior: pharmaceutical representative speakers, CME sponsorship, and industry-sponsored conference travel.31
Some individual physicians or groups are involved in industry sponsored clinical trials. Physicians should not participate in studies that are, in effect, thinly disguised promotional schemes to entice physicians to use a new drug.32 Another area of concern for physician bias and potential conflict of interest is physician investments in pharmaceutical and biomedical companies. This obviously can create a moral dilemma, and is an issue that has not been addressed by any of the major medical governing bodies based on the current recommendations available at this time.
In reference to residency training programs, many rely on pharmaceutical company financial support of CME programs and conferences. While guidelines became more specific in 2002, they are still not difficult to skirt.33 Anyone presenting educational information to physicians-in-training for which segments were provided by industry should disclose this information, and faculty and program directors may accept honoraria or subsidies only for services rendered and reasonable travel expenses. It also has been shown that interaction with pharmaceutical representatives during residency does affect the perception of practicing physicians during their medical career, where those unexposed were half as likely to view educational information and sponsored activities as helpful. A recent systematic review revealed the majority of resident physicians reported insufficient training about how to interact with pharmaceutical representatives, and almost half desired more teaching on the subject.34 In emergency medicine residency programs, residents were more likely than faculty to believe that gifts were an appropriate way to learn about new products.35
In conclusion, physicians should be aware of the relative inability to remain objective in relationships with pharmaceutical representatives as well as what constitutes an acceptable gift. It is each individual physician and residency program's responsibility to monitor their own professionalism as defined by the ACGME White Paper and our collective responsibility to patients to be aware of compromised objectivity in relation to gifts from the pharmaceutical industry. Once physicians are aware of their weaknesses, then those weaknesses may more easily be addressed.
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