Physicians and Industry

Over the past 50 years, pharmaceutical and medical device manufacturers have worked hand in hand with Physicians to greatly advance medicine in the United States. Undoubtedly, the advances have helped to improve the quality of life for millions of Americans. From the Ceramic Hip replacements that Jack Nicklaus promotes for Stryker, to Eli Lilly’s anti-depressant Prozac, Physicians and manufacturers have worked together to provide medical options to people that were unheard of only a few decades ago12. The new options, however, do come at a substantial price to the consumer. The amount of money associated with medical device manufacturers, pharmaceutical manufacturers, and the Physicians that use their products has brought the nature of their interactions under great scrutiny over the past 15 years. To put things in perspective financially speaking, Pfizer, Johnson and Johnson, Merck, Bristol-Meyers Squibb, and Abbott Laboratories,

five top U.S. pharmaceutical manufacturers, generated $154,530,000,000 of revenue in fiscal year 2004.3

Within the United States, there are many professional organizations and not-for-profit groups that exist solely for the advancement of medicine. With limited financial support from government and private citizens, these organizations tend to rely heavily upon the donations received from industry. In many cases, the clinical goals of the not-for-profit and manufacturing organizations are exactly the same. Pharmaceutical manufacturers, medical device manufacturers, and professional medical societies all have in common the pursuit of the advancement of medicine for mankind. Without a doubt, there are many other goals that the manufacturers and clinicians vie for, but their clinical goals tend to be well aligned. The next several paragraphs will outline the positive aspects surrounding industry money spent in support of clinically driven programs.

The American College of Cardiology (ACC) posts the following mission statement on its website: “The mission of the American College of Cardiology is to advocate for quality cardiovascular care—through education, research promotion, development and application of standards and guidelines—and to influence health care policy.”4 Each year, the ACC sponsors dozens of programs that all have the same focus: advancing research in cardiovascular disease.5 One such program is titled “ACCF/Guidant Foundation Fellowship and Career Development Award in Women’s Cardiovascular Health.”6 This program pays a Physician a salary to dedicate two full years researching a very important issue in our society, women’s cardiovascular health.7 For those associated with healthcare device manufacturers, one is quick to realize that this program is fully sponsored by Guidant, a Minneapolis-based manufacturer of cardiovascular medical products. Without their support, this particular program dedicated to advancing the treatment of cardiovascular problems in women would not exist. Without industry support, most of their programs would never get off of the ground. In 2002, Pfizer, AstraZeneca, Merck, Aventis, Bristol-Meyers Squibb, GlaxoSmithKline and Procter & Gamble, all pharmaceutical manufacturers, donated approximately $2,750,000 to the ACC.8

The American Heart Association (AHA) has an equally noble mission posted on its website: “The American Heart Association is a national voluntary health agency whose mission is to reduce disability and death from cardiovascular diseases and stroke.”9 One of their current campaigns, “Go Red for Women,” “is the AHA’s national call for women to take charge of their heart health and live stronger, healthier lives.”10 This program is dedicated to the education of the public and the advancement of the treatment of the number one killer of women in the world, heart disease.11 Pfizer Inc. is one of two national sponsors of the program; in May 2004 , AHA awarded Karen Katen, an Executive Vice President at Pfizer the "Woman With Heart" Award for her leadership at Pfizer in sponsoring the “Go Red for Women” campaign.1213 This is yet another example of a great program being financially supported by a pharmaceutical manufacturer.

Aside from the health-promoting organizations referenced above, pharmaceutical and medical device manufacturers have played a significant role in the advancement of medicine through their own individual efforts. Much of their inventions are simple in concept: enable someone to maintain a normal way of life through medicine. For the most part, their inventions aren’t dedicated to making individuals “superhuman.” Rather, the manufacturers seek to take someone that is not living a normal life based on pain or disease, and allow them to lead a normal life. Their mission statements closely resemble those of the not-for-profit organizations that they support. The next few paragraphs will highlight some of the more significant advancements in the past several decades.

Pfizer Inc. is a global manufacturer of pharmaceutical products. Their purpose, as stated on their website, is as follows: “We dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products.” 14 Over the years, they have invented and marketed some of the most well known drugs of our time. And in many cases, these drugs have enabled millions of people worldwide to live a substantially better life. Take for example their Erectile Dysfunction drug, Viagra. Approved by the FDA on March 27, 1998, it would be difficult to find anyone in the United States that hasn’t heard about it.15 Through aggressive marketing and collaboration with Physicians, more than 600,000 doctors have prescribed Viagra to over 23,000,000 men.16 Their list of approved over-the-counter drugs is impressive, and it wouldn’t be too far of a stretch to assume that most readers have used at least one of their products. Some of the more common over-the-counter products are: Benadryl, Cortizone, Desitin, Listerine, Lubriderm, Neosporin, Rolaids, Sudafed, and Visine.17 Hundreds of millions of people worldwide have benefited from the drugs that Pfizer has manufactured. Pfizer also donates extensively to not-for-profit medical organizations as well as a vast array of other entities. By its own estimates, Pfizer donates roughly “$2,000,000 every working day to provide medicine, medical care and community service to people who need help.”18 This type of philanthropy is not uncommon in the pharmaceutical manufacturing world.

Bristol-Myers Squibb is also a global manufacturer of pharmaceuticals. Their mission “is to extend and enhance human life by providing the highest-quality pharmaceutical and related health care products.”19 Like Pfizer, many of its well-known products have also contributed to the increased quality of life for millions of people. Drugs such as Excedrin, Taxol, Plavix, and Avapro were all developed by Bristol-Myers Squibb. In addition to providing people with pharmaceuticals to live better lives, Bristol-Myers Squibb has donated over $100,000,000 to research institutions for the advancement of medicine over the past 28 years.20

Medtronic is a global manufacturer of medical devices. Medtronic’s mission, as posted on their website, is “to contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.”21 Their products include pacemakers, defibrillators, spinal implants, heart valves, endovascular stent graphs, and a number of other life-saving products.22 Though much smaller than the pharmaceutical companies, Medtronic donated $7,846,834 in medical grants and donations in 2004.23 On a local note,

$205,000 was donated to the Minneapolis Heart Institute Foundation.24 Hundreds of programs and hundreds of thousands of patients have benefited from the products and philanthropy of Medtronic.

All in all, pharmaceutical and medical device manufacturing companies contribute much to the betterment of health in our society. Through their innovative products, they enable millions of people to lead normal lives. In some cases, their products allow people to live that otherwise could not. Individuals will pay as much as they can afford, and then some, to buy the drugs and devices that these companies manufacture, because the benefit of leading a normal life is often times more valuable than any financial burden. Because of this willingness to pay for items that often times are more expensive than a new car, there exists a highly competitive environment where manufacturers vie to gain the most market share of a given product or service line. There are two primary approaches to garnishing their share: they either market direct to consumers, or they market to consumers through Physicians.25

Marketing to consumers through Physicians is not a new concept for pharmaceutical and medical device manufacturers. Years ago, they realized the importance of the Physician-Patient relationship as it applied to their business model. In a testament to this concept, out of the $21,000,000,000 spent annually by pharmaceutical companies on marketing, 88 percent is directed at Physicians.26 This concept is also well known to regulatory agencies, as well as one of the most well respected Physician organizations, the American Medical Association (AMA).

The AMA’s mission is as follows: “The American Medical Association speaks out on issues important to patients and the nation's health. AMA policy on such issues is decided through its democratic policy-making process, in the AMA House of Delegates. The AMA’s envisioned future is to be an essential part of the professional life of every physician and an essential force for progress in improving the nation’s health. The AMA's activities with for-profit entities are directed by AMA guidelines for corporate relationships, and its Internet products follow AMA guidelines for health and information Web sites.”27 Of note is the reference in the last sentence to the AMA’s activities with for-profit entities and the guidelines that regulate them.28 The AMA recognizes the importance of their relationships with industry, as well as the money that goes along with the relationships.

In order to accomplish their mission, the AMA has developed a set of objectives to support the endeavor. The following paragraph was pulled from the “objectives” section of their website: “As the national professional organization for all physicians, the American Medical Association (AMA) serves as the steward of medicine and leader of the medical profession. The AMA’s envisioned future is to be an essential part of the professional life of every physician and an essential force for progress in improving the nation’s health. Only the AMA has the national voice, the reputation and the stature to be a strong advocate for physicians and their patients. Through active advocacy at all levels of the private and public sectors, we are working to protect the patient-physician relationship, which is at the heart of medicine. Advocacy takes many forms, including

public health initiatives, legislation, marketplace interventions and strengthening physician leverage in negotiations.”29 Of note in this section is the reference to the importance of the Physician-Patient relationship.30 The pharmaceutical marketing efforts are appropriately targeted at this relationship, which is “at the heart of medicine.”31

The AMA is no stranger to the amount of money that industry sends their way in the form of donations, grants, and medical research support. In fact, they rely heavily on it. The AMA is also aware of the problems surrounding this money, as well as the money that is directed at the Physicians in the form of marketing, along with the potential conflicts of interest that it creates. An organization built on an ethical foundation, the AMA knew that it needed to address the interactions of the members, Physicians, and the primary sponsors, manufacturers. Much of the marketing to the Physicians takes the form of “gifts” such as dinners, vacations, educational materials, and a vast array of other financial incentives. In order to address this issue, the AMA turned to the Council on Ethical and Judicial Affairs.

“The Council on Ethical and Judicial Affairs (CEJA) develops ethics policy for the AMA. Composed of seven practicing physicians, a resident or fellow, and a medical student, the Council prepares reports that analyze and address timely ethical issues that confront physicians and the medical profession.”32 “In December of 1990, the AMA’s House of Delegates adopted CEJA's ethical guidelines to prevent inappropriate gift-giving practices.” The AMA did not take this subject lightly. The following is the policy in its entirety:

Opinion 8.061, "Gifts to Physicians from Industry"Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational seminars and conferences. However, there has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines:

(1) Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. The use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples. It would not be acceptable for non-retired physicians to request free pharmaceuticals for personal use or use by family members.

(2) Individual gifts of minimal value are permissible as long as the gifts are related to the physician’s work (e.g., pens and notepads).

(3) The Council on Ethical and Judicial Affairs defines a legitimate “conference” or “meeting” as any activity, held at an appropriate location, where (a) the gathering is

primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. An appropriate disclosure of financial support or conflict of interest should be made.

(4) Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company’s

1 Stryker Website (Accessed March 31, 2005 at http://www.strykerceramics.com/index_general.php)2 Prozac Website (Accessed March 31, 2005 at http://www.prozac.com/index.jsp)3 Datamonitor.com Website (Accessed March 30, 2005 at http://www.datamonitor.com/~89c9f213bde84783937acf27b993ab63~/companies/lists/list/?listid=288ED715-62DE-417A-9787-A59D711272A5)4 American College of Cardiology Website (Accessed March 31, 2005 at http://www.acc.org/about/overview/history.htm)5 Ibid.6 Ibid.7 Ibid.8 Kassirer, Jerome P., MD. “On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health.” Oxford University Press, 2005. p. 106.9 American Heart Association Website (Accessed March 31, 2005 at http://www.americanheart.org) 10 Ibid. 11 The National Women’s Health Information Center Website (Accessed March 31, 2005 at http://www.4woman.gov/faq/heartdis.htm)12 American Heart Association Website (Accessed March 31, 2005 at http://www.americanheart.org)13 Pfizer Inc. Website (Accessed March 31, 2005 at http://www.pfizer.com)14 Ibid.15 PSA Rising Magazine Website (Accessed March 29, 2005 at http://psa-rising.com/timeline/)16 Viagra Website (Accessed March 31, 2005 at http://www.viagra.com/whyViagra/provenSafety.asp)17 Pfizer Inc. Website (Accessed March 31, 2005 at http://www.pfizer.com)18 Pfizer Inc. Annual Report. New York, 2002.19 Bristol-Myers Squibb Website (Accessed March 31, 2005 at http://www.bms.com/aboutbms/content/data/ourple.html)20 Bristol-Myers Squibb. Corporate Responsibility at Bristol-Myers Squibb Report. New York, 2003-2004.21 Medtronic Website. (Accessed March 31, 2005 at http://www.medtronic.com/hic/hic.html)22 Ibid.23 Ibid.24 Ibid.

representative may create a relationship that could influence the use of the company’s products, any subsidy should be accepted by the conference’s sponsor who in turn can use the money to reduce the conference’s registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.

(5) Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians’ time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. Token consulting or advisory arrangements cannot be used to justify the compensation of physicians for their time or their travel, lodging, and other out-of-pocket expenses.

(6) Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. Carefully selected educational conferences are generally defined as the major educational, scientific or policy-making meetings of national, regional or specialty medical associations.

(7) No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician’s prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.33

One of the underlying principles within these guidelines is to protect the patient from becoming entangled between Physicians and their ties with industry. “Patients must

25 Kassirer, Jerome P., MD. “On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health.” Oxford University Press, 2005. p. 77.26 Ibid.27 American Medical Association Website (Accessed March 31, 2005 at http://www.ama-assn.org/ama/pub/category/1815.html)28 Ibid.29 Ibid.30 Ibid.31 Ibid.32 Council on Ethical and Judicial Affairs, American Medical Association Website (Accessed March 31, 2005 at http://www.ama-assn.org/ama/pub/category/4325.html)33 Ibid.

be able to trust that their doctors’ motives are not subverted by financial gain, that their doctors are recommending treatments that benefit them, and that their doctors are involving them in research projects for the right reasons. Their doctors must not only be at their sides, but on their sides.”34 Though I would argue that most, if not all, Physicians are on the side of their patients, not all Physicians act on behalf of their patients without influence from a manufacturer.

To quote a statistic used earlier in this paper, $18,480,000,000 is spent by pharmaceutical firms marketing to Physicians; “with more than 600,000 Physicians in active practice, this amounts to more than $30,000 spent on each Physician.35 With that much money exchanging hands, one can readily assume that it is not being spent on pens and coffee mugs. The marketing techniques within the medical device and pharmaceutical manufacturing world are much deeper than that. In today’s society, there are many areas of concern surrounding the relationships between Physicians and manufacturers. In the following paragraphs, the paper will focus on four major areas. First, there is concern that the relationships impact the approval of drugs on the U.S. market. Second, there is concern that the Continuing Medical Education being taught to Physicians is biased toward individual drugs and products. Third, there is concern that Physicians push their patients toward drugs and devices that are manufactured by companies that they have financial ties with, or have simply received a free dinner or small gift from. Fourth, there is concern that the medical literature used by Physicians is itself biased by industry influence. The cornerstone of all of these arguments is that the Physician is unable to separate himself from the influence of a manufacturing company wholly enough to make a completely unbiased medical decision.

In January 1997, the Food and Drug Administration (FDA) approved Warner Lambert’s (now Pfizer) new drug for the treatment of diabetes, Rezulin.36 The process surrounding the approval, and eventual removal, of Rezulin in the U.S. market exposes the depth of Physician-Manufacturer relationships.

In the 1990’s, Rezulin was chosen for the National Diabetes Prevention Study by the National Institutes for Health (NIH).37 The NIH’s mission as stated on its website is as follows: “The National Institutes of Health is the steward of medical and behavioral research for the Nation. It is an Agency under the U.S. Department of Health and Human Services.”38 As referenced, the NIH is a government agency. During the initial trials, Dr. Richard Eastman was the top NIH diabetes researcher in charge of the National Diabetes Prevention Study.39 During this time, Dr. Eastman was an advisor for Warner-Lambert,

34 Kassirer, Jerome P., MD. “On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health.” Oxford University Press, 2005. p. xviii.35 Ibid. p.77.36 Ibid. p.46.37 Ibid.38 National Institutes for Health Website. (Accessed March 31, 2005 at http://www.nih.gov/about/)39 Kassirer, Jerome P., MD. “On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health.” Oxford University Press, 2005. p.47.

and was a speaker for a group that recommended that Physicians use Rezulin; for his services, Dr. Eastman was paid $78,455 by Warner-Lambert.40

As the clinical trials continued, “tests of liver functions began to show nearly four times more liver injury in people who were taking Rezulin in the NIH study than those who were taking placebos.”41 At nearly the same time, the FDA approved the drug.42 By December of 1998, 33 deaths had been attributed to the use of Rezulin, and in January of 1999, the FDA commissioner, Jane Henney, pulled together the Advisory Committee to determine a course of action.43 When the committee convened on March 25, 1999, “nine of the ten Physicians who reported on the safety and effectiveness of Rezulin were paid Warner-Lambert consultants.”44 The committee voted to keep Rezulin on the market, and an additional 30 deaths were attributed to the drug until its removal in 2000.45

It is not a rare occasion for a Physician to be involved with a FDA approval committee. In fact, Dennis Cauchon, in USA Today, revealed some extremely interesting statistics regarding the topic.46 “From 1998 to 2000, the FDA waived federal restrictions on conflict of interest numerous times to allow experts to testify about drugs in the FDA’s 18 advisory committees. He found that at 88 of 159 advisory committee meetings, half or more of the committee members had financial interests in the topic being evaluated.”47 Furthermore, “of the 102 meetings that involved specific drugs, Cauchon learned that one-third of the committee members had a direct financial stake in the outcome.”48

In looking at the Physician Gift Policy, point number five states that “…it is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses.”49

Another concern today is the relationship between Physicians, manufacturers, and Continuing Medical Education (CME). As the pace of medical advancements accelerated, CME credits were born as a safeguard to ensure that Physicians were keeping up to date with the latest techniques. Since its inception, CME has had support from manufacturers. This education sometimes takes place at an accredited institution, but more often than not, it takes place at the specialty organization meetings that the Physicians attend regularly.50

40 Ibid.41 Ibid.42 Ibid.43 Ibid. p. 48.44 Ibid.45 Ibid.46 Ibid. p.22.47 Ibid.48 Ibid.49 Council on Ethical and Judicial Affairs, American Medical Association Website (Accessed March 31, 2005 at http://www.ama-assn.org/ama/pub/category/4325.html)

Arguably, many CME courses offered to Physicians would never get an audience if it weren’t for the subsidies from the manufacturers. For example, at the 2002 American Heart Association annual meeting, the 30 free “symposia” that qualified as CME credits were all taught by instructors that were paid solely by the manufacturers.51 The beef with this concept is that there is concern that the free educational credits that the Physicians receive are biased toward the product of the manufacturer that funded the course. With the amount of market share at stake, it is hard to believe that a pharmaceutical or medical device manufacturer would spend the money on an educational event without a stake in the game. And, their stake does tend to be high. For their “teaching” services, the Physicians are paid well. At one AHA meeting, a “prominent cardiologist bragged to a young colleague that he made more than $100,000 at a single meeting.”52 With $100,000 from a manufacturer in a Physician’s pocket, it is easy to see the argument that the educational sessions sometimes end up as well-disguised sales pitches.

Another concern is that the gifts from industry, the speaking engagements, and the consulting fees paid by manufacturers influence the decisions made by Physicians regarding the use of certain products on their patients. The argument is that the Physician should make a decision based solely on what is best for the patient.

“Physicians’ fervent belief that industry-supported dinners, gifts, and trips do not influence them is base, in part, on their training designed to imbue a strong sense of objectivity.”53 Their “adherence to ‘evidence-based medicine’” further convinces them that objectivity is the only way they do business.54 However, studies have shown that they are susceptible to the influence of “gifts” from industry. In one study, “40 Physicians who requested additions to their hospital’s drug formularies were compared to 80 who had not requested any new drugs. Statistically, doctors who requested the additions were 9 to 21 times more likely than those who did not to have eaten free meals from the companies, to have accepted drug-company money to attend or speak at a company-sponsored symposium, and to have accepted research support from the drug companies.”55

Finally, there is concern that the medical literature used by Physicians is itself biased by industry influence. A popular publication, the Lipid Letter, is a publication produced by an organization by the name of Emerging Science of Lipid Management (ESLM).56The publication is focused “on management of lipid abnormalities and they focus on treatment with lipid-lowering drugs known as statins.”57 “The lead editorial in the October 2002 issue of the Lipid Letter by Dr. Antonio Gotto, the dean of Cornell Medical School in New York and Dr. Peter Libby, chief of Cardiovascular Medicine at

50 Kassirer, Jerome P., MD. “On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health.” Oxford University Press, 2005. p.16.51 Ibid. p.17.52 Ibid.53 Ibid. p.63.54 Ibid.55 Ibid. p.68.56 Ibid. p.97.57 Ibid.

Brigham and Women’s Hospital in Boston and co-chairs of ESLM, ‘challenge(d) the medical community to consider whether our present criteria for therapy (with statins) are too conservative,’ meaning that statins should be used much more widely.”58 Both Physicians had financial arrangements with Pfizer, maker of the best selling statin drug Lipitor.59 In fact, the “ESLM is completely underwritten by Pfizer.”60 Here is a well-known medical publication, viewed by thousands of Physicians, that is driven by a pharmaceutical giant. It would be tough to argue that Pfizer, with all of the money they spend on ESLM in a year, doesn’t have a hidden agenda that influences Physicians in their practices.

58 Ibid.59 Ibid.60 Ibid.

Additional Resources

Food and Drug Administration Website. Accessed March 30, 2005. <www.fda.gov>

Ely Lilly Website. Accessed March 29, 2005. <www.lilly.com>

Johnson and Johnson Website. Accessed March 29, 2005. <www.jnj.com>

Merck Website. Accessed March 30, 2005. <www.merck.com>

As referenced early on in this paper, both manufacturers and Physicians have contributed greatly to the advancement of medicine, and often times they have done so on a unified front. Each year, pharmaceutical and medical device manufacturers donate millions, if not billions of dollars toward medical research and a vast array of other worthy causes. Their inventions enable people to live longer, healthier lives. Their contributions to CME have enabled Physicians to keep up to date without spending thousands of dollars on courses. But, with the good comes the bad. There are concerns that the financial relationships between Physicians and manufacturers are causing them to make biased decisions on behalf of their patients. More to the point, some feel that Physicians are putting their own personal income before the needs of their patients. Several key medical associations have heeded the concerns, and have developed ethical guidelines for their members. Yet these associations also have a tendency to be funded by the pharmaceutical and device manufacturers. There is a lot of money on the table, and where there is money, there are watchdogs. With the recent articles in the national papers scrutinizing the relationships that the FDA has with the pharmaceutical industry, it won’t be too long before people start to look more closely at the relationships that your Physician has with his or her suppliers.

Additional Information

None. Since this is a “general” dilemma, I tried to give as many different real life examples as possible, to include the outcomes.

Case Questions

1. Should Physicians be allowed to accept gifts of any kind from manufacturers? Are pens and mugs acceptable? Lunches? Speaking arrangements? Where is the line? Are the AMA guidelines sufficient? Do you feel that they were written a bit vague for a reason?

2. Is it ethical for manufacturers to control the Continuing Medical Education curriculum in the United States? (In Dr. Kassirer’s book, he references that 75% of all CME credits are taught by professors being paid by manufacturers)

3. Should they be allowed to teach any of the credits?

4. Should it be mandatory for Physicians to visibly post their financial ties to industry in their office?

5. Is it anyone’s business?

6. Should manufacturers be allowed to participate in organizations such as the American Heart Association?

7. If so, should there be better guidelines surrounding their financial relationships with the members?

8. If not, where will the organizations go for funding?

9. Is it ethical for the FDA to waive its conflict of interest policy when bringing Physicians in to report about a certain drug? (they currently do) With all of the relationships that exist, where would the FDA go to get unbiased opinions?

10. Should Physicians working for governmental agencies be allowed to receive honorariums, gifts, and consulting fees from industry? What is the difference between them and a Physician working in a small practice in Northern Minnesota? The current rules state that they should disclose any financial ties when a conflict of interest arises. Is this enough, or should they be excluded from that particular issue? Some of these Physicians have been quoted as saying that they are being paid by 50-70 different manufacturers, representing tens of thousands of products. Certain medical journals have removed the conflict of interest clause from their publications because they couldn’t find anyone without a financial tie to write the articles.

Works Cited