Healthy Skepticism Library item: 19008
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Rodwin MA
Drug Advertising, CME and Physician Prescribing--A Historical Review and Reform Proposal
Conundrums and Controversies in Mental Health and Illness 2010;
Full text:
Public policy tries to promote appropriate drug use by allowing firms to market drugs in interstate
commerce only for uses that the Food and Drug Administration (FDA) has found to be safe and effective. Because of their medical knowledge, physicians
are authorized to prescribe drugs even for uses unapproved by the FDA. Nevertheless, physicians have relied on drug firms for information on appropriate prescribing despite the inherent tension between drug firm dissemination of information to promote sales and rational prescribing. In the past, physicians often relied particularly on drug firm advertising for information
on drug use. Today, physicians rely on drug firms to finance continuing medical education (CME). A historical review reveals connections between these two different ways commercial interests have influenced
the information that physicians receive and points the way to needed reforms.1
Drug Information from Advertising, Commercial Publications, and Detailers
Writing in the Journal of the American Medical Association
(JAMA) in 1908, AMA president George H. Simmons accused drug firms of flooding medical journals
with promotional material in the guise of articles. “The fact that the Abbot Alkaloidal Company spends thousands of dollars in advertising its products in the various journals that carry these ‘original articles’ and ‘testimonials’ might explain why they were published.”2 He also said that Abbott’s publication, the American Journal of Clinical Medicine, was merely a means of promotion.
To influence prescribing, pharmaceutical firms also developed sales representatives known as medical detailers, to meet with physicians, tell them about new drugs, and pitch their products. Early in the 20th century,
detailers became the main source of drug information
for physicians, prompting professional leaders to advocate reforms.3 In 1929, speakers at an AMA symposium proclaimed “the need to replace the detail man as the main source of instruction in the use of medicines by professional, noncommercial sources of information.” They decried the lack of an independent “guide in judging the claims of clever advertising and the detail men,” the financial links between pharmaceutical
firms and physicians writing articles on the drug’s effectiveness, and the compromised ability of medical journals to assess drugs as a result of “receiving
slices of the [advertising] appropriation.”4
Nevertheless, advertising continued to be confused with education. From 1959-1961, Senator C. Estes Kefauver (D-Tenn.) investigated the pharmaceutical
industry and championed enactment of the Food, Drug and Cosmetic Act (FDCA) 1962 amendments. Testifying in 1959, Tobias Warner, marketing director for Smith Kline & French, said “pharmaceutical promotion
differs from consumer promotion to the laity [because it] … is dedicated almost as much to educating
and imparting essential information as it is to selling.”
Dr. Austin Smith, president of the Pharmaceutical
Manufacturers’ Association (PMA) made the same claim in his testimony.5
However, Dr. Charles May, editor of the AMA journal Pediatrics, who served on the AMA Council on Drugs, criticized this view in his article “Selling Drugs by Educating
Physicians.” He warned that the “independence of physicians is … threatened by … drug manufacturers
… [that] promote their products by assuming an aggressive role in the education of doctors.”6 At the Kefauver hearings he testified that advertising was “the masquerading of promotion as education” and that “pharmaceutical promotion cannot be accepted as [a] trustworthy means of bringing accurate information
… to physicians.”7 He cited advertisements in journals
(including JAMA) that made false, misleading, or unsubstantiated claims; one asserted a drug was safe after an article in the same journal warned of its risks. Dr. May criticized industry subsidies of medical journals, conferences, and the medical education. He charged that “medical organizations are given moneys to support a large part of their activities and then are medical
journals. JAMA income grew until the late 1940s, when other physician journals offered advertisers an alternative. Then JAMA advertising declined.
From 1950 to 1956, the AMA employed Ben Gaffin
and Associates for advice on increasing its journal advertising. In one report, Gaffin wrote, “The AMA can … make advertising a … force for helping the practicing
MD keep current on developments which have occurred after he has completed his formal medical training.”12 The AMA then made numerous changes to make JAMA more attractive for drug advertising. Whether for that reason or others, the AMA ended its program of approving drugs in 1955 and then phased out its strict review of drug advertising. JAMA advertising
then rebounded. The AMA supported pharma’s in a poor position to criticize practices that infringe on the prerogatives of the medical educator.” 8
Other Kefauver hearing testimony revealed that some journals, such as Current Therapeutic Research, were mainly marketing vehicles. Drug firms paid to have their manuscripts published without peer review, purchased expensive reprints, and distributed them to “educate” physicians.9 Some journals “refused to publish
articles criticizing particular drugs … lest advertising
suffer.”10
The AMA tried to balance practice based on knowledge
with reliance on drug advertising, thereby creating “internal schisms” between “ties to the pharmaceutical industry” and “rational therapeutics.”11 Since 1847, the AMA had condemned secret nostrums — drugs with undisclosed ingredients marketed to laymen and physicians
— yet depended on advertising them to finance its journal. After 1900, AMA revenue from membership
dues increased, which allowed it to end its dependence
on advertising secret nostrums and to reform drug marketing. In 1905, the AMA began to grant seals of approval to drugs meeting several conditions. Manufacturers had to list all ingredients on labels (the accuracy of which the AMA confirmed through testing),
only market to physicians, and comply with other rules. The AMA ceased advertising all drugs it did not approve, but recouped that lost income because what it called ethical drugs could now only advertise in medical claim that advertising was educational, and argued until 1969 that JAMA advertising revenue should therefore not be taxed.13 After the FDA prosecuted one drug firm for false advertising, however, the AMA said that accuracy of drug advertising was a manufacturer responsibility, acknowledging that it did not ensure accuracy of materials it deemed educational.14 Misleading
drug advertising continues today.15
After World War II, drug firms also increased financial
support for professional societies and education.
In a 1953 article titled “Interdependence of the Medical Profession and the Pharmaceutical Industry,” Hoffmann-LaRoche’s Dr. Elmer Sevringhaus reported requests for drug firms to make “larger contributions
to medical education” and that “universities and larger hospitals are asking … for undesignated grants [for use] at the discretion of the staff….”16 By 1967, the Department of Health and Human Services (DHHS) reported that “many of the functions of the AMA and other national, state and local medical groups are financed … by PMA member companies.”17 Some physicians became alarmed. In 1969 Senate hearings, Dr. James Faulkner proclaimed, “No organization which purports to represent the medical profession should [be] … largely dependent on … drug advertising.”
In 1971 Senate testimony, Dr. Robert Seidenber noted that opponents of national health insurance had warned about dangers of third party payers, but that the drug industry was not ‘a more acceptable … bedfellow.”18
The Rise of Continuing Medical Education
Pharma and the AMA claimed that advertising was educational when physicians received little post-residency
training. Few medical schools offered courses for practitioners until the 1940s.19 Physician opposition
prevented the AMA from requiring CME, but starting in 1968, it granted CME recognition awards. In 1971, state medical societies began to require members
to receive CME, but there was no accreditation or evaluation of CME.20 Starting in 1971, the AMA offered recognition awards only to organizations accredited by its Council on Medical Education, and the Council subsequently delegated certain accreditation activities to state medical societies. Along with others, in 1977, the AMA founded the Liaison Committee on Continuing
Medical Education (LCCME) to take on its role in CME accreditation.21
By 1976, industry-funded CME attracted the attention
of Senator Gaylord Nelson (D-WI) who chaired extensive hearings on the pharmaceutical industry and medical education.22 Dr. Richard Crout, M.D., Director of the Food and Drug Administration, Bureau of Drugs, testified that extensive drug industry underwriting of postgraduate education developed in the last decade.23 Industry funding created bias, he said, because “…the industry sponsor can choose from among the many medical authorities on any given topic to support only those whose views already coincide with the interests of the sponsor.”24 Senator Nelson recalled the warning
of Dr. Charles May 15 years earlier regarding drug company promotion through medical education.25 He asked, “How can we trust any program sponsored by the industry as being educational rather than promotional?”
26 He pursued the implications by questioning
“whether drug companies … should be allowed by hospitals and physicians to intrude into the education business in any fashion whatsoever …, would it not be much better if … all of the post medical education were in the hands of the scientific community and the medical schools …?”27
In 1980, the AMA and six other organizations formed the Accreditation Council for Continuing Medical Education (ACCME) as the successor to the LCCME.28 Since then, the ACCME accredits entities to offer CME and also authorizes some other institutions
and organizations to accredit CME providers. In addition, the ACCME develops criteria to evaluate educational programs, which the ACCME and state accrediting bodies use in accrediting CME providers. States that require physicians to obtain CME credits specify that they do so from organizations that they or the ACCME accredit.
At the time the ACCME began, eight states required CME for physicians.29 There were a few commercial firms that provided CME (called Medical Education and Communication Companies or Medical Education Service Suppliers). They included publishers, insurers,
a managed care trade group, and the drug firm Eli Lilly. Commercial CME providers often also performed
pharmaceutical marketing or public relations work. Most CME, however, was organized by medical
schools and medical societies, although they often used medical education companies to help develop the program materials.
Eager to avoid paying for CME themselves, physicians
accepted commercially funded CME. No one set CME requirements regarding what topics should be offered or content of curricular, so commercial funding determined the topics offered. As drug firms increased funding, for-profit accredited CME providers grew from ten in 1990 to 68 by 2000 and 158 by 2006.30 In 2006, the ACCME accredited 730 providers directly and 1684 providers indirectly using 46 organizations that the ACCME recognizes as state-based accrediting
organizations that follow ACCME standards.31 Accredited providers include: physician membership organizations, for-profit firms, medical schools, hospitals/
health care systems, nonprofit organizations, governmental entities, insurers, and other unclassified entities. In 2006, they produced 149,889 CME activities.
In addition to accredited CME, pharma and commercial
interests organize activities that they deem to be CME, even though they are not accredited.
In 1990, Senator Edward Kennedy (D-MA) chaired hearings on pharmaceutical industry marketing that documented, among other questionable activities, the use of CME to market drugs. David Jones (formerly vice-president of Abbot Laboratories and CIBA-GEIGY executive director for government and public affairs) testified that “[m]edical education today is now determined by what the marketing department wants….” “Promotion disguised as education is sponsored
by bogus organizations” on behalf of marketing departments and routinely promotes “unapproved and unproven” drug uses. Furthermore, “Doctors …are recruited to publish helpful articles which are produced
by company medical writers who assure that the marketing messages are featured.”32
In 1991, the FDA concluded that drug companies used CME to promote drugs, sometimes even for unapproved
uses.33 Some programs recommended calcium channel blockers, approved to control arrhythmia, for use after heart attacks; this off-label use resulted in tens of thousands of deaths according to the FDA.34 The promotion of unapproved drug uses through CME continues. 35 In 2005 Serono labs paid $704 million as part of a settlement of a government suit that alleged it used education grants to market Serostim, a drug approved to treat AIDS, for off label uses.36 The Wall Street Journal reported that in 2006, Glaxo SmithKlein
funded a CME program that advocated the use of its herpes drug, Valtrex, to treat neonatal herpes, an unapproved use.37
Drug companies publicly maintained that CME providers
were independent, but one individual reports that these companies sometimes refer to CME providers
as their “agency,” the same term they use to refer to medical communication companies who develop promotional
and advertising materials.”38 Moreover, CME providers traditionally sought funds from one firm per program, because, as a manager of a CME provider explained to me, drug firms believed a provider supported
by two or more firms with competing drugs would have a conflict of interest.39 Drug firms typically funded CME from their marketing budgets and often played a major role in its development. They chose the faculty, often selected individuals with whom they had financial ties, supplied them with slides and written materials, and sometimes changed the speaker’s text over their objection. They linked grants to hospitals placing their drug on its formulary. CME providers attracted support by saying they helped promote sales. In 2001, one wrote it creates “educational programs … designed to gain a higher rate of acceptance at the launch of a new product and to increase return on investment.”40
Drug firm spending on accredited CME and other so-called educational programs has grown vastly in recent years. Industry spending on accredited CME was $302 million in 1998, over $1.071 billion in 2004 (with $197 million more for advertising), and over $1.5 billion in 2007, constituting over half of all funding for CME.41 Moreover, less than 9 percent of the nearly 500,000 physician meetings and symposia in 2006 were accredited CME; 89 percent of all unaccredited meetings — which sponsors usually claim are educational
— were closely associated with drug firms.42
Commercial interests — mainly pharmaceutical and medical device firms — generate the overwhelming
share of income of for-profit CME providers. However,
they also supply more than half the income for not-for-profit CME providers. In 2008, commercial interests funded 71 percent of commercial providers’
income, but they also funded over 59 percent of medical school CME income, and over 47 percent of physician organization CME income. Indeed, physician
organizations earned higher rates of profit from their CME revenue (32 percent) than did commercial providers (26 percent).43
A lawsuit settled in 2005 illustrates some marketing/
CME abuses. Four years after Parke-Davis introduced
Neurontin (Gabapentin), 90 percent of its prescriptions were for unapproved uses. Parke-Davis funded studies on unapproved uses and publicized positive findings but not those unfavorable. It hired medical education companies to produce articles, review papers, and letters that advocated off-label uses and paid physicians to sign as the authors. It sponsored studies as a means to teach physicians drug doses for unapproved uses. It employed a firm to market
Gabapentin while also funding it for CME on topics
for which Gabapentin could be used. Parke-Davis employees met with the CME provider to develop the curricula; the faculty advocated Gabapentin for unapproved
uses.44
Oversight of Commercial Support for CME
Until 1990, drug firms routinely paid physicians’ expenses for professional meetings registration, travel, and lodging. Then, seeking to prevent stricter federal oversight, the AMA and Pharmaceutical Research and Manufacturer’s Association (PhRMA) voluntary guidelines prohibited such funding. Nevertheless, in 2004, over a quarter of doctors reported commercial firms paid their expenses.45 By 1991, when the FDA planned to curb the use of CME to promote drugs for unapproved uses, several studies concluded there was CME funding bias.46 Yet medical societies opposed regulation and funding restrictions. Kirk Johnson, senior vice president of the AMA, told Medical Marketing
& Media, “industry support of education is … critically important … we’ll die for that position, and … vigorously defend it in our meetings with [the FDA] Commissioner.”47
The FDA’s 1992 draft policy held that drug firm-controlled
programs could not recommend unapproved drug uses, but that independent CME could. It considered
a drug company funded program independent if the provider had a contract that granted it control and specified that the program was not for promotion. Funders could recommend individuals as faculty, if the program disclosed this. CME providers and faculty had to disclose their financial relationships with commercial
funders. Faculty that discussed off-label drug uses had to state that they were not FDA approved. The FDA relied on the ACCME to monitor compliance.
48 In 1992, the ACCME revised its Standards for Commercial Support to follow FDA standards.49
Organized medicine and pharma criticized the draft and in 1997, the FDA issued weaker final guidelines. The FDA said it would not prosecute CME providers that only failed to meet one of its criteria for independence
and promoted unapproved drug uses. The Washington Legal Foundation (WLF), a pro-business,
free-market advocacy group, sued the FDA.50 It argued that the CME guidelines, and other guidelines that restricted drug firms from disseminating articles on off-label drug uses, violated free speech. In 2000, a trial court sided with the WLF. In arguments before the appeals court, the FDA said it no longer held that the FDCA prohibited drug firms from disseminating articles on off-label drug uses and was withdrawing both these and the CME guidelines.51 from a commercial interest as conditions of contributing
funds or services” (emphasis added).56 That language does not prohibit commercial supporters from offering advice, CME providers from soliciting suggestions from them, or CME providers voluntarily following suggestions of commercial supporters. My interviews with CME providers indicated that these were common practices.
Since 2005, ACCME guidelines disqualify CME faculty and program managers with financial ties to commercial firms unless they have independent peers review the program materials to rule out bias.57 The Meanwhile, the Office of Inspector General (OIG), which combats kickbacks and fraud in Medicare and Medicaid, turned its attention to drug firms. In 2002, it proposed as a regulation, guidelines that restricted pharma funding of professional activities. In response, the AMA and PhRMA beseeched the OIG to drop restrictions on funding CME, research, and scholarships;
25 medical organizations (including the American
College of Physicians, the American College of Surgeons, and the Association of American Medical Colleges) made similar requests.52 Several specialty societies said all pharma grants to medical societies should be allowed.53
The OIG 2003 final guidelines adopted these suggestions,
stating “support for educational activities sponsored and organized by medical professional organizations raise little risk of fraud or abuse.”54 However, following the FDA, it said that commercial funders risk prosecution when they control CME. It recommended that drug firms separate marketing from grant making.55 Since then, separate entities organize CME and marketing. Sometimes, however, one company owns both a CME provider and a drug marketing firm. Still, the ACCME appeared to allow providers to show potential and current funders their draft program and receive suggestions. Its 2004 Standards
for commercial support said, “A provider cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants
or other education matters, including content, guidelines say that other measures might resolve the conflict of interest but that disclosure is insufficient.
In 2007, the Senate Committee on Finance investigated
industry-funded CME. Its report noted that the ACCME accreditation “relies … on information supplied
by the CME providers … [yet it] detects… significant
… noncompliance.” It concluded that ACCME standards were inadequate because the “provider can technically maintain ‘control’ of content … while continuing
to accommodate suggestions from the companies
that control their funding. Providers can “afford drug companies the ability to target their grant funding
at programs likely to support sales of their products.”
58 In reply to the Senate Committee, the ACCME wrote in part, “The ACCME recognizes that CME can receive financial support from industry without receiving
any advice or guidance, either nuanced or direct, on the content of the activity or on who should deliver that content” (emphasis added).59 Later, in answers to frequently asked questions, the ACCME interpreted its standards for commercial support to preclude providers
soliciting suggestions or advice from commercial supporters or their showing commercial supporters draft programs before the CME activity occurred.60
In 2009, an Institute of Medicine report on medical conflicts of interest in medical education, research and practice found that CME was “too reliant on industry funding” and so had “a narrow focus on products.”61 Moreover, an AMA Council on Ethical and Judicial Affairs report stated it is ethically preferable for medical organizations to avoid accepting funds for CME from firms with an interest in physician prescribing, but that accepting commercial support is permissible if the provider directs the program and discloses the funding source.62 But the House of Delegates did not adopt that position, so it is not AMA policy. In an article discussing earlier AMA discussion of CME, Dr. Arnold Relman, former editor of the New England
Journal of Medicine, wrote that neither the AMA House of Delegates nor the American Association of Medical Colleges (AAMC) Executive Counsel want “to cut off industry support of CME because … they see no other source of funding….”63 This explanation also seems to explain the delegates recent decision.
Reforming the Financing of CME
Reform proposals abound.64 A common suggestion is that disclosing financial ties will resolve the problem. Yet noting conflicts of interest does not prevent or remove bias.65 Others urge stronger accreditation standards.
However, the ACCME only accredits organizations,
which then develop whatever CME they wish. It does not accredit CME programs or determine the topics offered or program content. And its oversight relies mainly on volunteers and self-reporting. The American Association of Medical Colleges propose that CME offerings be “externally spot-reviewed or audited for … the presence of inappropriate influence.”66
Some physicians argue that for-profit providers cater to the interests of commercial funders, and believe that only medical schools and medical societies should be accredited to sponsor CME.67 Certainly some commercial
CME providers used to function as marketers. But that has changed and today CME providers are compromised because they depend on industry funding.
But so do medical schools and medical societies.68 All CME providers must develop programs that commercial
interests find appealing if they want to receive commercial support.
Others propose that drug firms pool contributions and collectively fund programs. That would prevent individual firms from choosing individual CME programs,
but CME would still depend on commercial support. As one proponent admits, “Any industry-sponsored CME pool might still favor CME activities that generally promote interventions involving pharmaceuticals
or devices.”69 Another option is to channel all contributions to an independent “central repository [which] … would disburse funds to ACCME-approved programs.”70 Yet presumably firms would not contribute
unless the central repository generally chose topics
that they wanted. The ACCME suggests limiting accredited CME to topics chosen by a respected third party, but that alone does not specify funding among topics, or oversee curricula, and that still relies on discretionary
support.71 Still another suggestion is that CME providers simply not accept any funding from commercial interests.72 This is unlikely to occur unless legislation prohibits CME providers from accepting
funding from commercial interests. Moreover, that would not rule out commercial influence unless the legislation also prohibited CME providers from accepting funds from foundations and associations that received grants, advertising income, or other support
from commercial interests.
A New Proposal
Contrasting CME with other medical education reveals the key problem. Accrediting organizations and governmental
authorities establish curricula for undergraduate
and graduate medical education. Medical schools do not offer courses based on what commercial
interests voluntarily fund. Yet for CME, there is no required curriculum. CME topics are closely related to products of drug firms because it is financed by their voluntary contributions. One industry commentator suggests that there are areas of convergence of interest
between business interests and health care system quality gaps.73 However, in its 2010 report, Redesigning
Continuing Education in the Health Professions, the Institute of Medicine concluded that “funding should be directly aligned with the goals of driving improved quality of care and patient safety….”74 Furthermore,
it notes that “without funding from conflicted
sources, continuing education content would likely shift away from knowledge about specific drugs and devices.”75
Organizations unaffiliated with commercial interests
should develop required CME curricula based on assessments of problems that exist in medical practice,
the educational needs of physicians, and which educational interventions will yield the most benefit.76 Public authorities should raise and allocate funds. Congress should impose a CME tax on commercial medical firms, insurers, medical facilities, and perhaps
even physicians.77 A federal authority should allocate these funds to government-certified not-for-profit institutions created for the purpose of distributing
these funds to independent entities that develop CME. Commercial interests should not be allowed to donate funds, even indirectly, for accredited CME. In short, CME providers should not be permitted to receive funds even from foundations, associations, or organizations that receive any grants, other income, or support from commercial interests.
How would the taxed entities pay for their increased expenses? They could either absorb it and lower their profits, or pass along the cost through increased prices. American drug firms could easily absorb this cost; since the 1950s they have consistently earned higher profits than the Fortune 500 companies have.78 Of course, entities taxed might increase their prices to cover the expense. However, insurers already finance most medical spending and adding the cost of accredited
CME would be relatively small. Support for CME totals around $2 billion annually, 0.0013 percent of national health care spending in 2008, about $6.58 per person.79 Having the public shoulder that burden through insurance is feasible. Moreover, improved CME would reduce inappropriate drug prescribing and improve the quality of care, a worthwhile change that might also lower medical spending.
In fact, public finance of CME would probably not increase much what the public already pays. Commercial
interests already fund most CME. If they now pass on these costs in the price of their products, then insurers and the public already pick up the tab. In that case, doesn’t it make sense for the public to choose how to use these funds and to ensure that CME is unbiased? And if commercial interests now absorb the cost of CME, why would that not also occur if they pay a CME tax — unless pharmaceutical marketing is incompatible with medical education?Acknowledgements
Taya Mashburn provided research assistance. Hervé Maisonneuve provided helpful comments. Funded in part by a summer research grants from Suffolk University Law School, and Université de Rennes, l’Institut de l’Ouest: Droit et Europe, UMR CNRS 6262.
References
1. I develop the themes in this article, along with analysis of other financial conflicts of interest, in M. A. Rodwin, Conflicts of Interest and the Future of Medicine: The United States, France and Japan (New York: Oxford University Press, forthcoming February, 2011).
2. G. H. Simmons, “The Abbott Alkaloidal Company – High Finance and Methods of Working the Medical Profession,” JAMA 50, no. 11 (1908): 897.
3. U.S. Federal Trade Commission, Economic Report on Antibiotics
Manufacturers (Washington, D.C.: Government Printing Office, 1958): at 128. R. Ferber and H. G. Wales, “The Effectiveness
of Pharmaceutical Promotion,” in University of Illinois Bureau of Economic and Business Research Bulletin (Urbana: University of Illinois Press, 1958).
4. C. D. Leake, “The Pharmacologic Evaluation of New Drugs,” JAMA 93, no. 21 (1909): 1632-1634. See also E. E. Irons, “The Clinical Evaluation of Drugs,” JAMA 93, no. 20 (1929): 1523-1524; W. A. Puckner and P. N. Leech, “The Introduction of New Drugs,” JAMA 93, no. 21 (1929): 1627-1630.
5. Study of Administered Prices in the Drug Industry, Report No. 448, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress (1961) (statement of Warner); see id., at 210. Study of Administered Prices in the Drug Industry, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress, at 210 (1961) (statement of Smith).
6. C. D. May, “Selling Drugs by Educating Physicians,” Journal of Medical Education 36, no. 1 (1961): 1-23.
7. Study of Administered Prices in the Drug Industry, Report No. 448, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress (1961) (testimony of Dr. Charles D. May at hearings, citing T. Wagner in Ethical Pharmaceutical
Promotion: The Workings and Philosophies of the Pharmaceuticals
Industry (New York: National Pharmaceutical Council,
Inc., 1959).
8. Id.
9. Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress (1961).
10. Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, Administered Prices Drugs, U.S. Senate Hearings, vol. 18, 10, 338 (1960) (testimony of William B. Bean, Chair of the Department of Internal Medicine, University of Iowa Medical School).
11. S. H. Podolsky and J. A. Greene, “A Historical Perspectives of Pharmaceutical Promotion and Physician Education,” JAMA 300, no. 9 (2008): 1071-1073; J. A. Greene and S. H. Podolsky,
“Keeping Modern in Medicine: Pharmaceutical Promotion
and Physician Education in Postwar America,” Bulletin of the History of Medicine 83, no. 2 (2009): 331-377.
12. Gaffin Report, reprinted in U.S. Senate Hearings, at 505 (1961-1962).
13. Committee on Ways and Means (1969) (statement from Bernard
D. Hirsh before U.S. Senate, cited in M. Silverman and P. Lee, Pills, Profits & Politics [Berkeley: University of California Press, 1974]: at 53-54); M. Mintz, “JAMA Pleads Case for Tax Exemption,” Washington Post, March 20, 1969, at 24.
14. M. Mintz, “Not-Guilty Plea Entered in False Drug Ad Case,” Washington Post, December 7, 1965, at 12.
15. P. Villanueva, “Accuracy of Pharmaceutical Advertisements in Medical Journals,” The Lancet 361, no. 4 (2003): 26-32.
16. E. Sevringhaus, “Interdependence of the Medical Profession and the Pharmaceutical Industry,” JAMA 152, no. 16 (1953): 1525.
17. Task Force on Prescription Drugs, Office of the Secretary, U.S. Department of Health, Education, and Welfare, The Drug Makers and the Drug Distributors (1968), at 6.
18. Subcommittee on Monopoly, Select Committee on Small Business, Present Status of Competition in the Pharmaceutical
Industry, 91st Congress 4056 (1969), at 10 (testimony of James M. Faulkner); Select Committee on Small Business, Present Status of Competition in the Pharmaceutical Industry, Subcommittee on Monopoly, 91st Congress, 5727 (1969), at 14, (testimony of Edward Pinkney); Subcommittee on Monopoly, Select Committee on Small Business, Effect of Promotion and Advertising of Over-the-Counter Drugs on Competition, Small Business, and the Health and Welfare of the Public, 92nd Congress
541 (1971), at 2.
19. K. M. Ludmerer, Time to Heal: American Medical Education from the Turn of the Century to the Era of Managed Care (New York: Oxford University Press, 1999): Chap. 4, the “Rise of Graduate Medical Education,” at 79-101.
20. D. W. Petit, “The Physician Recognition Award,” JAMA 213, no. 10 (1970): 1668-1670; N. S. Stearns, M. E. Getchell, and R. A. Gold, Continuing Medical Education in Community Hospitals:
A Manual for Program Development (Boston: Massachusetts
Medical Society, 1971).
21. Institute of Medicine, Committee on Planning a Continuing Health Professional Education Institute, Redesigning Continuing
Education in the Health Professions (Washington, D.C.: National Academies Press, 2010), available at
22. Subcommittee on Monopoly of Select Committee on Small Business, Competitive Problems in the Drug Industry, Part 30, 94th Congress, 2nd Session (1976).
23. Id., at 13919.
24. Id., at 13920.
25. Id., at 13913.
26. Id., at 13914.
27. Id., at 14015.
28. The organizations that founded and govern Accreditation Council for Continuing Medical Education (ACCME) are thefollowing: American Board of Medical Specialties; American Hospital Association; American Medical Association; Association
of American Medical Colleges; Association for Hospital Medical Education; Council for Medical Specialty Societies; and Federation of State Medical Boards of the U.S.
29. American Medical Association, U.S. Medical Licensure Statistics
1985 and Licensure Requirements 1986 (Chicago: American
Medical Association, 1987): at Table 14, 30; American Medical Association, Continuing Medical Education for Licensure
Reregistration, State Medical Licensure Requirements and Statistics, 2009 (Chicago: American Medical Association, 2008).
30. Data supplied by ACCME for 2000 and 2006, Data for 1990 from personal communication from Murray Kopelow, President,
ACCME to author (November,2007); see also, E. D. Peterson, K. M. Overstreet, J. N. Parochka, and M. R. Lemon, “Medical Education and Communication Companies in CME: An Updated Profile,” Journal of Continuing Education in the Health Professions 24, no. 8 (2008): 205-219.
31. Statement from the Accreditation Council for Continuing Medical education (ACCME) to the Institute of Medicine Committee on Conflict of Interest in Medical Research, Education,
and Practice, June 2008, at 5, available at
September 30, 2010).
32. Senate Committee of Labor and Human Resources, Advertising,
Marketing and Promotion, 101st Congress (1990), at 174-175.
33. A. Witt, “Drug Company Supported Activities in Scientific or Education Contexts: Draft Concept Paper,” Federal Register 57, no. 229 (1991): 56412 (obtained under the Freedom of Information
Act).
34. “Final Guidance on Industry-Supported Scientific and Educational
Activities,” Federal Register 62, no. 232 (December 3, 1997): 64074-64100.
35. J. N. Joseph, D. Deaton, H. Ehsan, and M. A. Bonanno, “Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where are We Going?” Journal of Health & Life Sciences Law 2, no. 2 (2009): 73-108.
36. Civil Settlement Agreement between the United States and Serono, Inc., available at
37. D. Armstrong, “Drug Firm’s Cash Sways Debate Over Test for Pregnant Women,” Wall Street Journal, December 13, 2006, at A1.
38. Personal communication from Anonymous to author (September
2007).
39. Personal communication from Mark Schaffer to author (October
2007).
40. Physicians World, available at
41. Institute of Medicine, Redesigning Continuing Education in the Health Professions, supra note 21.
42. R. Steinbrook, “Financial Support of Continuing Education in the Health Professions,” in Continuing Education in the Health Professions: Improving Healthcare Through Lifelong Lessons, at 104-126, available at
43. The ACCME distinguishes between commercial support (grants to CME providers) and income from advertising and exhibits at CME meetings. I included both under commercial support. Most funding comes from the grants. See ACCME, Annual Report Data 2004, available at
44. See M. A. Steinman, L. A. Bero, and M. Chren et al., “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal
Industry Documents,” Annals of Internal Medicine 145, no. 4 (2006): 284-293. See, also United States of America ex. Rel David Franklin vs. Pfizer, Inc, and Parke-Davis, available through
45. E. Campbell, R. Gruen, and J. Mountford et al., “A National Survey of Physician-Industry Relationships,” New England Journal of Medicine 356, no. 17 (2007): 1742-1750.
46. M. A. Bowman, “The Impact of Drug Company Funding on the Content of Continuing Medical Education,” Mobius 6, no. 1 (1986): 66-69; M. A. Bowman and D. L. Pearle, “Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education,” Journal of Continuing
Education in the Health Professions 8, no. 1 (1988): 13-20; R. W. Spingarn, J. A. Berlin, and B. L. Strom, “When Pharmaceutical Manufacturers’ Employees Present Grand Rounds, What do Residents Remember?” Academic Medicine 71, no. 1 (1996): 86-88. However, in 2008, the ACCME commissioned
a report to review published studies on the effect of commercial support on CME in terms of bias. The authors reviewed ten empirical studies and concluded the evidence was inconclusive. See R. M. Cervero and J. He, The Relationship between Commercial Support and Bias in Continuing Medical
Education Activities: A Review of the Literature, 2008, available at
47. A. Witt, “AMA Guidelines: ‘We’ll Stay the Course. Here’s Why,’” Medical Marketing & Media 26 (1991): 82-88.
48. The FDA said CME programs are unlikely to be independent if: it focuses on a single product; a commercial firm owns the CME provider or employs it for marketing or sales, or recommends
individuals who promote its products as faculty, or arranges program invitations or disseminates program materials
through its marketing department; a provider is not financially viable without a single commercial firm’s support, has significant contacts with FDA-regulated firms, or previously
organized programs that did not meet standards for independence.
49. ACCME, Standards for Commercial Support, 1992, available through
50. See id. (Relman, 2001).
51. “Final Guidance on Industry-Supported Scientific and Educational
Activities,” Federal Register 62, no. 232 (1997) (the FDA issued new guidelines on dissemination of articles in 2009); “Guidance for Industry Good Reprint Practices for the Distribution
of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” Federal Register
74, no. 8 (2009): 1694-1695.
52. U.S. Department of Health and Human Services, Office of Inspector General, Draft OIG Compliance Program (2002), at 62057-62067; S. Chimonas and D. J. Rothman, “New Federal Guidelines for Physician-Pharmaceutical Industry Relations: The Politics of Policy Formation,” Health Affairs 24, no. 4 (2005): 949-960 (AMA comments on the draft, submitted by Michael Maves, Executive Vice President, obtained via FOIA).53. See, for example, American Association of Electro-diagnostic Medicine, Comment No. 55, American College of Rheumatology,
American College of Chest Physicians, Comment No. 87, the Endocrine Society, Comment No. 106.
54. U.S. Department of Health and Human Services, Office of Inspector General, Compliance Program Guidance for Pharmaceutical
Manufacturers,” Federal Register 68, no. 86 (2003).
55. U.S. Department of Health and Human Services, Office of Inspector General, “Compliance Program Guidance,” Federal Register 68, no. 86 (2003).
56. Standard 3.2.
57. Accreditation Council for Continuing Medical Education, Updated Standards for Commercial Support: With Back-ground Rationale and Answers to Questions about Compliance, Chicago, 2004); R. Steinbrook, “Commercial Support and Continuing
Medical Education,” New England Journal of Medicine 352, no. 6 (2005): 534-535.
58. Letter from Max Baucus, Chair, Senate Finance Committee,
to Murray Kopelow, ACCME, April 27, 2007, available at
59. Letter from Murray Kopelow, Chief Executive of ACCME to Max Bucus and Charles Grassley, Senate Committee on Finance, August 3, 2007, available at
30, 2010); see also, ACCME “Announcements,” August 24, 2007, available at
60. The ACCME made this clear in its response to frequently asked questions on line, see, ACCME response to frequently asked questions regarding commercial support and independence,
available at
61. Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice (Washington, D.C.: National Academies
Press, 2009).
62. AMA, Council on Ethical and Judicial Affairs, CEJA Report–A-09 “Financial Relationships with Industry in Continuing Medical Education,” 2009, available at
September 30, 2010).
63. A. S. Relman, “Industry Support of Medical Education,” JAMA 300, no. 9 (2008): 1071-1073.
64. L. Morris and J. K. Taitsman, “The Agenda for Continuing Medical Education – Limiting Industry’s Influence,” New England
Journal of Medicine 361, no. 25 (2009): 2478-2482; R. Steinbrook, “Financial Support of Continuing Medical Education,”
JAMA 299, no. 9 (2008): 1060-1062; Institute of Medicine,
Redesigning Continuing Education in the Health Professions,
2010, at Chap. 3, “Regulation and Financing,” at 55-78; Association of American Medical Colleges, Industry Funding of Medical Education: Report of an AAMC Task Force, Washington,
D.C., 2008, available at
Medical Education: Investments in Physician Human Capital,” JAMA 302, no. 16 (2009): 1807-1808.65. M. A. Rodwin, “Physicians’ Conflicts of Interest: the Limitations
of Disclosure,” New England Journal of Medicine 321, no. 20 (1989): 1405-1408; Association of American Medical Colleges, The Scientific Basis of Influence and Reciprocity: A Symposium, Washington, D.C, 2007, at 22-23.
66. Association of American Medical Colleges, Industry Funding of Medical Education, 2008, at viii.
67. See Relman (2001), supra note 49.
68. J. P. Kassirer, “Professional Societies and Industry Support: What Is the Quid Pro Quo?” Perspectives in Biology and Medicine
50, no. 1 (2007): 7-17; J. P. Kassirer, On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2005).
69. See Morris and Taitsman, supra note 64, at 280.
70. T. A. Brennan, D. J. Rothman, and L. Blank et al., “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,” JAMA 295, no. 4 (2006): 429-433.
71. Accreditation Council for Continuing Medical Education, Accredited CME Is Education That Matters to Patient Care, June 2008, available at
72. L. Morris and J. K. Taitsman, “The Agenda for Continuing Medical Education – Limiting Industry’s Influence,” New England
Journal of Medicine 361, no. 25 (2009) 2478-2482; H. Brody, Hooked: Ethics, the Medical Profession, and the Pharmaceutical
Industry (Lanham, Maryland: Rowman & Littlefiled
Publishers, Inc., 2007): at 328-330; M. Angel, The Truth About the Drug Companies: How They Deceive Us and What to Do About It (New York: Random House, 2004): at 250-252; Institute of Medicine, Redesigning Continuing Education
in the Health Professions, supra note 21, at 207.
73. M. Saxton, “A View from Industry: The Foundations of Future Commercial Support and a Call for Action,” Journal of Continuing
Education in the Health Professions 29, no. 1 (2009): 71-75.
74. Institute of Medicine, Redesigning Continuing Education in the Health Professions, supra note 21, at 73.
75. Id.
76. R. H. Brook, “Continuing Medical Education: Let the Guessing
Begin,” JAMA 303, no. 4 (2010): 359-360; P. E. Mazmanian
and D. A. Davis “Continuing Medical Education and the Physician as Learners Guide to the Evidence,” JAMA 288, no. 9 (2002): 1057-1060.
77. See Rodwin, supra note 1.
78. Senate investigations found that pharmaceutical industry net profits after taxes from 1958-1959 were 21 percent. U.S. Senate Subcommittee on Antitrust and Monopoly, 1965, 278. Peter Temin analyzed the data from the FTC, SEC, and other studies and concluded that profits after taxes were between 17 percent and 19 percent from 1948 through 1973; see P. Temin, Taking Your Medicine, Cambridge: Harvard University Press, 1980): at 80-82. For other analysis of pharmaceutical industry profits, see M. Angel, The Truth About Drug Companies: How They Deceive Us and What To Do About It (New York: Random House, 2004).
79. National health spending for 2008 was estimated at $2.4 billion,
or about $7,900 per person, based on a July 2008 U.S. population estimate of 303,824,640. See S. Keehan, A. Sisko, and C. Truffer et al., “Health Spending Projections through 2017: The Baby-Boom Generation Is Coming to Medicare,” Health Affairs 27 (2008): W145-W155, available at
