Capture of Academic Medicine by Big Pharma
By Bruce Patsner, M.D., J.D.
The ongoing saga of the relationship between drug companies and doctors continues with
no end in sight to the litany of bad press,1 reported financial conflicts of interest,2
allegations of “ghost-writing” of medical articles by pharmaceutical company-employed
physicians,3 and intentional omission of data from critical clinical studies used to support
off-label claims for certain therapeutics.4 Certainly, the topic has received a great deal of
attention in the academic medical press over the past five years or more. The history of
significant medical literature on the subject easily goes back almost three decades to
when Arnold Relman became the first editor of The New England Journal of Medicine to
use his bully pulpit to write about the dangers of the “medical-industrial complex.”5
Several medical societies as well as noted health law policy gurus in The New England
Journal of Medicine and The Journal of the American Medical Association have also
been critiquing the relationship between academic medicine and big pharmaceutical
companies for several years.6 Ironically, some of the authors of the editorials in these
U.S. peer review journals are members of the faculty of the same medical schools as
some of the alleged offenders.7
The lay press has also zeroed in on this “story of corruption.”8 Within the past several
years at least four books have been published in the U.S. describing the potentially
deleterious effects on public health which may result from the deepening financial ties
between pharmaceutical companies and academic physicians whose writings often
significantly affect the potential market value of new prescription drugs.9 The problem is
not just that some physicians, particularly some in positions of significant academic
power at prestigious institutions, have received enormous amounts of money from
pharmaceutical companies for giving dozens of talks on behalf of pharmaceutical
1
Eric G. Campbell, Joel S. Weissman, Susan Ehringhaus, et al, Institutional Academic-Industry
Relationships, 298 JAMA 1779 (2007).
2
Gardiner Harris and Benedict Carey, Researchers Fail to Reveal Full Drug Pay, THE NEW YORK TIMES,
June 8, 2008 at A1.
3
Bruce M. Psaty and RA Kronmal, Reporting mortality findings in trials of rofecoxib for Alzheimer disease
or cognitive impairment: a case study based on documents from rofecoxib litigation, 299 JAMA 1813
(2008).
4
Marcia Angell, Industry-Sponsored Clinical Research. A Broken System, 300 JAMA 1069 (2008).
5
Arnold S. Relman, The new medical-industrial complex, 303 N. ENGL. J. MED. 963 (1980).
6
The American College of Obstetricians and Gynecologists, ACOG Committee Opinion, Relationships
with Industry, Number 401, March 2008.
7
Eric G. Campbell, Doctors and Drug Companies – Scrutinizing Influential Relationships, 357 N. ENG. J.
MED. 1796 (2007).
8
Marcia Angell, Drug Companies & Doctors: A Story of Corruption, THE NEW YORK REVIEW OF BOOKS,
January 15, 2009 p. 8-13.
9
These recent books include: (1) Alison Bass, SIDE EFFECTS: A PROSECUTOR, A WHISTLEBLOWER, AND A
BESTSELLING ANTIDEPRESSANT ON TRIAL (2008); (2) Melody Petersen, OUR DAILY MEDS: HOW THE
PHARMACEUTICAL COMPANIES TRANSFORMED THEMSELVES INTO SLICK MARKETING MACHINES AND
HOOKED THE NATION OF PRESCRIPTION DRUGS (2008); (3) Christopher Lane, SHYNESS: HOW NORMAL
BEHAVIOR BECAME A SICKNESS (2008); and (4) Howard Brody, HOOKED: ETHICS, THE MEDICAL
PROFESSION, AND THE PHARMACEUTICAL INDUSTRY (2007).
companies promoting those companies’ drug products to other physicians at national
medical meetings, hospital department meetings, or specially convened teleconferences
all under the umbrella of medical education.10 Nor is the problem that, at least in some
extreme cases, the amounts of money these physicians have received were not properly
reported to either the academic institutions they were affiliated with or the Internal
Revenue Service, in violation of both medical school academic policy and federal law.11
The problem now is that there is a serious question about whether such occurrences, and
the apparent lax oversight some medical schools and academic medical centers appear to
practice, is the result of the medical school’s own conflicts of interest. And it is not just
confined to state and private medical schools either; several highly publicized problems
with financial conflicts of interest and unapproved transfer of federal intellectual property
have also occurred at the National Institutes of Health.12
Barriers Between Academic Medicine and Pharmaceutical Companies Continue to Fall
Despite all of the adverse publicity of the past several years, it appears that the barriers
between academic medicine and the pharmaceutical industry are continuing to fall
despite all of the lip service being paid to institutional ethics rules and talk of new
guidelines. Just when you thought things couldn’t get any worse,13 along comes a story
which signifies a new low in the race for the bottom to see which academic medical
institution can cement its relationship to a major pharmaceutical company. In a
newspaper article published in January in The Wall Street Journal,14 it was reported that
Johnson & Johnson and Vanderbilt University Medical School had agreed to an
unusually extensive partnership to develop new drugs to treat schizophrenia.
Unlike the usual agreements between pharmaceutical companies and medical school
researchers in which the drug maker typically funds the university’s basic science
research in exchange for the first rights to buy any commercially promising drugs which
are developed, the reported agreement between Johnson & Johnson and Vanderbilt
involves not just discovering potentially valuable new compounds by medical school
researchers directly for the pharmaceutical company but also a highly organized,
expensive effort at “optimizing” the toxicity profile of the drugs so that they are ready for
human testing.15 Traditionally, this work has been done in-house by the pharmaceutical
companies themselves. In exchange for all of this bench and clinical research, Vanderbilt
is slated to receive up to $100 million in payments if certain research and clinical
10
Gardiner Harris, Leading Psychiatrist Didn’t Report Drug Makers’ Pay, THE NEW YORK TIMES, October
8, 2008 at A1.
11
The amount of annual income derived from speaking engagements on behalf of pharmaceutical
companies in several cases exceeded $500,000 per annum.
12
Robert Steinbrook, Financial Conflicts of Interest and the NIH, 350 N. ENGL. J. MED. 327 (2004).
13
A slide shown during a lecture at the semi-annual Gynecologic Oncology Group (GOG) meeting two
years ago given to a group of prominent clinical investigators in gynecologic cancer on faculty at major
medical schools across the U.S. read “The GOG should partner with industry and do their bidding.”
14
Shirely S. Wang, J&J, Vanderbilt Team Up on Schizophrenia Drugs, THE WALL STREET JOURNAL,
January 9, 2009 at B1.
15
Id.
milestones are met.16 Dr. Jeffrey Conn, the pharmacology professor who heads
Vanderbilt’s drug-discovery program, pledged to publish scientific findings whether the
results benefit Johnson & Johnson or not in response to concerns that there is the
potential for significant conflicts of interest in the proposed arrangement.17
It remains to be seen whether the promise to publish negative results will actually take
place since the precise details of the contractual agreement have not been made public. It
is not clear who actually “owns” the data, nor is it obvious that publishing “negative”
data is sufficient counterweight to the enormous financial stake the medical school now
has in ensuring that newly developed compounds successfully complete clinical trials and
ultimately reach consumers. The agreement between Vanderbilt and Johnson & Johnson
is also being inked despite that fact that Alastair J.J. Wood, currently Associate Dean at
Vanderbilt Medical School, has been one of the strongest critics of current U.S. Food and
Drug Administration (FDA) policies on new drug approval, post-marketing surveillance,
and academic medical-industry relations.18
No Federal Rules, Only Standards and Guidelines
All of the recent news on financial conflicts of interest in the growing partnering of
academic medicine and the pharmaceutical industry raises troublesome questions about
the ability of either the medical profession or private industry to self-regulate their
conduct. Indirectly, it remains to be seen whether new agreements between academic
medicine and big pharmaceutical companies such as those between Vanderbilt and
Johnson & Johnson will further interfere with FDA’s ability to fulfill its mission of
protecting the U.S. public from unsafe medical products.
Addressing the problems of potential financial conflicts of interest and the welldocumented problems of transparency of clinical trial information will not be easy.
Although both medical professional societies and NIH have issued statements on
industry-academic relations, these proclamations only rise to the level of standards and
guidelines. Even if such institutional guidelines are binding on the scientists and clinical
investigators they employ, they are only as effective as the enforcement actions
undertaken when there are violations. If penalties are mild, standards are lax or are rarely
enforced, or the guidelines vary too much from academic medical institution to institution
it is doubtful the current situation will change. This raises the question of whether more
federal oversight is required, as some have proposed.19 The other unanswered question is
whether the situation is likely to change given the harsh economic realities of
progressively declining federal funding for academic medical research and changes in
federal rules years ago which helped create the current situation.
16
Id.
Id.
18
Statement by Alistair Wood at U.S. Food and Drug Administration, Center for Drug Evaluation and
Research, Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management
Advisory Committee, February 16, 2005.
19
David M. Studdert, Michelle M. Mello, & Troyen A. Brennan, Financial Conflicts of Interest in
Physicians’ Relationships with the Pharmaceutical Industry – Self-Regulation in the Shadow of Federal
Prosecution, 351 N. ENGL. J. MED. 1891 (2004).
17
Where Things Might Be Headed
Are things going to change? With a new Democratic administration in Washington, D.C.
that promised more regulatory oversight of industry during the Presidential campaign, it
might be possible.
The pharmaceutical industry has already anticipated that the playing field will likely
change in physician-pharmaceutical relationships and that new stronger federal rules may
be on the way. Several large pharmaceutical companies (Eli Lilly and Merck) have
already indicated that they will voluntarily begin to disclose payments they make to
physicians.20 In 2007, the Physician Payments Sunshine Act21 (so named because
legislation such as this is designed to “let the sun shine in” and reveal otherwise private
information) was introduced by Sen. Charles Grassley (R-IA). This proposed law was
designed to prevent the violations of federal and university conflict-of-interest rules and
to replace the hodge-podge of state laws and voluntary compliance systems at medical
schools.22 Although this bill never became law because it had not been passed before the
end of that session of Congress, it is likely that the bill will be introduced again.23
Some medical schools have taken more aggressive steps to limit the access
pharmaceutical companies have to medical students and physicians in training.24 They
have begun revising physician-in-training educational programs so that the medical
schools, not pharmaceutical companies, are the primary sources of post-graduate
education of physicians,25 and have developed on-line public disclosure of academic
physician-pharmaceutical industry financial and research relationships.26 What impact
these changes may have is currently unknown.
Health Law Perspectives (February 2009), available at:
http://www.law.uh.edu/healthlaw/perspectives/homepage.asp
20
Benedict Carey, Two Big Drug Makers to Begin Disclosing Payments They Make to Doctors, THE NEW
YORK TIMES, September 25, 2008 at A16.
21
S. 2029, 110th Congress, “Physician Payments Sunshine Act.” This bill would have amended title XI of
the Social Security Act to provide for transparency in the relationship between physicians and
manufacturers of drugs, devices or medical supplies for which payment is made under Medicare, Medicaid,
or SCHIP.
22
Robert Steinbrook, Disclosure of Industry Payments to Physicians, 359 N. ENGL. J. MED. 559 (2008).
23
A Physician Payment Sunshine Act of 2009 is in the works, available at
http://grassley/senate.gov/private/upload/12209.pdf (last accessed January 29, 2009).
24
The Associated Press, Med schools, journals fight big pharma’s sway, September 10, 2008, available at
http://www.msnbc.msn.com/id/26622463/print/1/displaymode/1098/ (last accessed September 22, 2008).
25
Id.
26
Robert Steinbrook, Online Disclosure of Physician-Industry Relationships, 360 N. ENGL. J. MED. 325
(2009).