What is the problem?

In 2004, members of a research team published the first national survey of physician-industry relationships (PIRs), in which 94% of respondents reported at least 1 type of industry relationship. However, these relationships are varied. The 2004 study showed that receiving prescription samples or food in the workplace was reported most frequently, and reimbursement for the costs of medical meetings or continuing education, as well as speaking and consulting fees, were common.

In 2010, a similar national survey was repeated. A stratified random sample of 2938 primary care physicians (internal medicine, family practice, and pediatrics) and specialists (cardiology, general surgery, psychiatry, and anesthesiology) were approached. A total of 1891 physicians completed the survey, yielding an overall response rate of 64.4%. The main outcome measurement was prevalence of PIRs and comparison with PIRs reported in 2004. The results of the 2010 study showed that, overall, 83.8% of all respondents reported some type of relationship with industry during the previous year, a 10% decline from 94% in 2004. Of those with PIRs:

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  63.8% received drug samples, down from 78% in 2004

  
  
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  70.8% received food and beverages, down from 83% in 2004

  
  
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  18.3% received reimbursements, including continuing medical education (CME), down from 35% in 2004

  
  
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  14.1% said they had been given payments for serving on advisory boards and enrolling patients in clinical trials, compared with 28% in 2004.

The 2010 study also found that the number of meetings respondents reported having with pharmaceutical company representatives decreased from an average of 3 a month to 2 a month. The investigators noted that this change could reflect greater pressures on a physician’s time as well as institutional policy changes.

Cardiologists were most likely to report industry relationships, whereas psychiatrists (a specialty not included in the earlier survey) were the least likely. Physicians in solo, 2-person, or group practices were more likely to receive drug samples, meeting reimbursements, or gifts than those in hospitals and medical schools, but academically based physicians were most likely to receive payments for speaking, consulting, or serving on advisory boards.

Although the landscape of PIRs has changed significantly since 2004, many physicians still value their work and collaboration with industry. The author of these 2 studies noted that, although “physician-industry relationships have decreased significantly since 2004, they are still found among more than three-quarters of those responding to our survey.” He asserted that, based on “the persistence of industry’s substantial financial interaction with U.S. physicians, there is a need for a nationwide system to publicly report these relationships.”

ProPublica and Consumer Reports performed a survey investigating patients’ perspectives regarding physicians who accept Pharmaceutical Research and Manufacturers Association (PhRMA) payments. The survey indicates that patients are largely unaware of the nature of physician/PhRMA contacts, and 74% of survey respondents disapproved of physicians taking payments for promoting medications to other physicians. Furthermore, 95% of respondents noted that their physicians had not disclosed any PhRMA payments, and 70% thought that physicians should disclose that information. The survey shows that most (51%) respondents thought that payments as low as $500 could influence a physician’s judgment.

What stance have academic medical centers taken?

The current trend of academic medical centers (AMCs) and professional organizations to adopt policies that restrict and/or police permissible interactions and activities between industry and physicians originated from a set of recommendations proposed by Brennan and colleagues in 2006. The proposed policies placed restrictions on faculty, residents, students, and staff that prohibit the receiving of gifts, samples, and many other activities.

One of the main reasons AMCs began to adopt these policies was as an attempt to avoid financial conflicts of interest that could compromise core values of altruism and fiduciary relationships. They propose that profit motives and financial gains unavoidably introduce bias in medical decision making and violate public trust, which suggests that profit is not a value that should be held by clinicians. However, many clinicians admit that the reality of their employment and pay is determined by the profitability of an AMC or a private entity.

What stance have academic medical centers taken?

The current trend of academic medical centers (AMCs) and professional organizations to adopt policies that restrict and/or police permissible interactions and activities between industry and physicians originated from a set of recommendations proposed by Brennan and colleagues in 2006. The proposed policies placed restrictions on faculty, residents, students, and staff that prohibit the receiving of gifts, samples, and many other activities.

One of the main reasons AMCs began to adopt these policies was as an attempt to avoid financial conflicts of interest that could compromise core values of altruism and fiduciary relationships. They propose that profit motives and financial gains unavoidably introduce bias in medical decision making and violate public trust, which suggests that profit is not a value that should be held by clinicians. However, many clinicians admit that the reality of their employment and pay is determined by the profitability of an AMC or a private entity.

What about clinician education with industry?

In today’s rapidly changing medical environment, health care practitioners in every area, including gastroenterology, depend on new clinical information and data to learn about breakthroughs in science and medical technology. Although some health care practitioners can learn about such breakthroughs from colleagues or attendance at major medical meetings, and others can read about them in journals, most practitioners are simply time limited or resource limited in their ability to find the pertinent information to help them improve their skills and knowledge.

Local CME is an option for health care practitioners to learn about new information and updates to guidelines and best practices in specific clinical areas. These local events may be sponsored by a local university, medical society or other qualified CME organization. The local aspects of these events can avoid the cost and time associated with traveling to a meeting. In other situations, some practitioners choose purely commercial events, sponsored by a specific pharmaceutical or medical device company, to learn about a new product, treatment, use, or indication. Other health care practitioners learn about new drugs and treatments by participating in research sponsored in part or entirely by the pharmaceutical industry. The Internet has provided many on-line programs for education, some CME approved, others either sponsored by industry or individual clinicians.

Throughout all of these interactions, health care practitioners depend on a certain level of interaction with industry. The clinician-industry relationship is essential for many reasons and, without it, transmission of medical information, development and improvement in medical products, and advancements in patient care could be hampered.

Where should the clinician and industry marketing intersect?

One of the types of physician-industry interactions that have been heavily criticized in the past several years is product marketing. Many anti-industry critics believe that pharmaceutical and medical device companies use marketing techniques, marketing representatives, and other mechanisms to influence the clinical decisions and prescribing behavior of health care practitioners. Although there were abuses in the past, such as discussing the off-label use of products with physicians, the provision of lavish free meals and inappropriate gifts, kickbacks for product use, and consulting fees directly tied to a product’s use, times have changed significantly since then and such behaviors today are now limited. Policies enacted by PhRMA ( Box 1 ) and AdvaMed ( Box 2 ) have placed strict bans on gift giving, and numerous regulations from the US Food and Drug Administration (FDA), Health and Human Services (HHS), Department of Justice (DOJ), and Office of the Inspector General (OIG) have made the risk and penalty for any illegal behaviors severe. The enforcement of such rules in the past several years has increased greatly through efforts to eliminate fraud and abuse in government programs such as Medicare and Medicaid.

However, the controversy in this area persists with passionate feelings aligned on both sides of the debate. An example of this is an article published by Brody and Light in the American Journal of Public Health proposing a concept known as the pharmaceutical inverse benefit law.

According to the investigators, this inverse benefit law shows how pharmaceutical marketing affects the clinician decision-making process when prescribing medications. A summary of the article in the Journal of the American Medical Association summarized the law and explained that the “law was inspired by the inverse square law of physics.” This law suggests that there are 6 marketing strategies that create an environment in which prescribing certain drugs could undermine, rather than promote, patient safety and public health. These 6 proposed marketing strategies are:

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  Reducing thresholds for diagnosing disease. For example, type II diabetes guidelines have gradually reduced the blood glucose threshold at which diabetes should be diagnosed and medically treated despite a lack of evidence that tight control improves major outcomes.

  
  
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  Relying on surrogate end points. When physicians accept surrogate end points rather than improved clinical outcomes as goals of therapy, fewer patients need to be treated with a drug or a device to show an improved outcome, even though that outcome may not directly benefit the patient.

  
  
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  Exaggerating safety claims. By overemphasizing the safety of a new drug that has been used in few patients, marketers encourage physicians to prescribe the medication to an expanded population of patients with milder symptoms, thereby exposing larger numbers of individuals to the drug and, therefore, to the potential for adverse events.

  
  
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  Exaggerating efficacy claims. When an expensive new drug performs no better than established lower-cost therapies but may have an advantage for a small subset of a patient population, marketers emphasize the latter to imply that the new drug is better than an established therapy.

  
  
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  Creating new diseases. For example, the invention of the disease categories of prehypertension and prediabetes potentially expands the patient population to be treated medically. However, this approach requires treating much larger numbers of persons to benefit a few.

  
  
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  Encouraging unapproved uses. Because promoting unapproved uses of a drug is illegal, some marketers have used tactics such as manipulating the content of CME programs, hiring leading physicians to give presentations recommending off-label use.

However, critics of this article note that the investigators provide no evidence of how often this occurs and include no evidence of harm to patients from this subtle manipulation. There was no economic number placed on these subtle manipulations. Critics also note that, although there have been abuses in the past, which may correspond with some of the marketing principles listed earlier, these abuses are rare and are handled and corrected through legal and regulatory actions. In addition, critics state that the proposed efforts to nullify these marketing effects, although potentially creating a safety net to penalize the worse offenders, creates more unnecessary confusion about what kind of information physicians can receive from the industry marketing arena and could potentially harm patients when physicians refuse to look at studies or research or collaborate with industry for fear of subtle manipulation. These critics also note that Americans are generally not living longer today because of a better diet and exercise; they are living longer because there are medications and devices that prevent and treat disease. Overcorrection of the clinician-industry relationship could significantly impair important advances in medicine.

What is the stance of the Association of American Medical Colleges?

The Association of American Medical Colleges (AAMC) recently considered a task force report on developing guidelines to manage PIRs. This report recommends, among other things, the development of policies that prohibit all gifts from industry for physicians, faculty, staff, students, and trainees of AMCs, either on-site or off-site. The report also recommends that the prohibition apply to equipment and service vendors.

According to the report, medical centers should discourage their faculty, students, and trainees from:

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  Attending nonaccredited industry events that are marketed as CME

  
  
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  Accepting payment for attendance at industry-sponsored meetings

  
  
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  Accepting gifts from industry representatives at meetings

  
  
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  Participating in ghostwriting.

Further, the task force recommends that pharmaceutical representatives not be permitted access to patient care areas, that device representative visits be limited to those who are appropriately credentialed, and that such visits be only at the request of a physician.

The ramifications of the AAMC policy are evident in the current degree of oversight of pharmaceutical and device manufacturer interaction with clinicians on a local level. An example of this is the Conflict of Interest in Clinical Care – Policy on Pharmaceutical and Medical Device Relationship from the University of Washington, St Louis, Missouri. This policy noted that pharmaceutical and medical device representatives have an interest in making health care professionals aware of their products and new product developments. They noted that, although interactions with sales representatives have a legitimate purpose, it is essential that information provided by these individuals is free of bias and financial inducements that might unduly influence medical decision making. The purpose of the policy was to define ethical standards for interacting with pharmaceutical and medical device manufacturers. This policy defined these clinician-industry relationships as follows:

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  Vendor sales representatives are allowed on Washington University School of Medicine (WUSM) premises only by appointment and only in department-designated areas as approved by the Department Chair, Program Director, or their respective designees.

  
  
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  Vendor sales representatives are prohibited from having direct patient contact. Any exceptions to this policy must be approved by the Department Chair or Program Director and limited to situations in which the presence of a medical device representative is essential because of the complexity of the medical device being used.

  
  
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  Pharmaceutical/medical device manufacturers may only provide unrestricted educational grants to a central fund with the approval of the Department Chair, Program Director, or their respective designees. The fund is independent of any industry input or control.

  
  
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  Grants may be used for medical education purposes including, but not limited to, medical textbooks, honoraria, and expenses for extramural lecturers and the provision of modest food/meals.

  
  
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  Grants cannot be conditional or related in any way to any preexisting or future business relationship with the industrial sponsor.

  
  
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  The content of the educational program and related materials must be under the exclusive control of WUSM.

  
  
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  Financial support of programs can be acknowledged in text in program announcements (eg, “This program was supported in part by an educational grant from …….”).

  
  
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  When industry provides support of CME-accredited educational activities, additional CME guidelines and procedures for commercial support of educational activities must be followed.

  
  
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  Educational events may be publicized if supported by an unrestricted educational grant.

These policies are not the most restrictive among academic centers. There is recognition from AMCs that industry representatives may be needed by clinicians during the use of complicated medical devices. Many AMCs rely on a pool of money to be used as deemed fit by the Department Chair or Program Director for education events and other industry-related activities. This pooled funding may seem logical but may jeopardize industry-sponsored CME programs if companies cannot justify the expense of donating monies that may serve the greater good but have no relationship to a company’s future success and future ability to contribute funds for medical education. In addition, most AMCs have not taken the initiative in providing their own postgraduate physicians with the training and education in and on complicated medical devices or complicated medical therapy that results in increased hospital reputation, increased hospital profit, and improved patient care.