Policy and Medicine

New England Journal of Medicine Editorial on COI In Academic Medicine – Misses the Mark

 

Using the recent change in policy at Partners Health Care in Boston, Massachusetts, as an example, Bernard Lo, M.D., recently wrote an article in the New England Journal of Medicine (NEJM) examining “Serving Two Masters: Conflicts of Interest in Academic Medicine.”

 

While he acknowledges that “relationships between academia and industry have both benefits and risks,” his article seems to focus more on the risks. Specifically, he tries to analyze the differences between academic health centers (AHCs) and for-profit medical companies to highlight the potential problems that may arise from industry-academic relationships. One problem with such a contrast is that it underscores the “close collaboration between academia and industry that has facilitated the development of many new drugs” that Dr. Lo himself professes.

 

In addition, using this “apples and oranges” comparison ignores the fact that academic-industry relationships allow “key interests to be aligned.” For example, as “the public seeks effective new therapies, academia wishes to translate basic discoveries into treatments, and industry wishes to develop new products.”

 

Dr. Lo also recognizes that the new Partners policy notes that “both academia and industry may benefit when academic leaders serve on company boards.” He even asserts that such work with “companies may benefit from the wisdom of senior academic physicians who learn about emerging trends in basic research and health care.” As a result of this collaboration, Dr. Lo admits that “academic leaders may learn innovative approaches to organizing scientific research teams or running large, complex organizations, and their networking with other board members may enhance fund-raising.” Essentially, this work creates an environment that encourages further success in all stages of creating new drugs and treatments for patients.

 

Although he discusses the obvious benefits from these relationships, Dr. Lo still maintains that because the goals of AHCs may “diverge from that of for-profit medical companies,” organizations must “take the initiative to promote a culture of accountability and a commitment to professionalism.” It seems apparent that AHCs who facilitate the development of new drugs, and who translate basic discoveries into treatments are promoting the highest level of accountability and professionalism, since their work is helping patients directly.

 

Dr. Lo believes however, that only AHCs “are driven largely by the goals of deepening our understanding of health and disease and providing high-quality care.” In reality, AHCs and for-profit companies work together to accomplish these goals. In fact, without industry support, many of the goals from AHCs would never be realized and as a result, their understanding of health and disease and ability to provide high quality care would be significantly diminished.

 

Just because companies “develop profitable new products” does not mean they share a different goal from AHCs. In fact, companies who develop profitable new products almost always invest their profits immediately into developing new drugs and treatments. Dr. Lo’s belief that for-profit companies only undertake public health work if it enhances their or conforms to their plan for charitable giving is problematic for two reasons.

 

First, for-profit companies, like GlaxoSmithKline support public health regardless of profits, as we previously wrote. Second, medical companies by their nature of risk and investment must undertake projects that return profits otherwise, the expenses associated with testing, research and development would shrink significantly, causing less drugs and treatments to be made. Despite these contradictions, Dr. Lo recommends that several questions regarding the relationships of AHCs and for-profit companies should be asked.

 

First, can situations be identified in which academic leaders who are board members face a sharp divergence between the interests of the AHC and those of the company? Second, in such situations what strategies might be adopted to reduce the risks to the AHC to an acceptable level (e.g. recusal)?

 

Third, could the interactions between academic leaders and industry be restructured in such a way as to preserve the mutual benefits of the relationship while greatly reducing the risks? Dr. Lo suggests that “leaders of AHCs might serve as consultants or nonvoting board members, rather than as officers who assume fiduciary responsibility to companies.” Fourth, what amount of money in directors’ fees may the AHC leader retain? Lastly, is effective oversight in place at the AHC? Dr. Lo mentions the recent report he coauthored on conflicts of interest from the Institute of Medicine (IOM), which recommended using the board of trustees of the AHC to review COIs.

 

Since AHCs work with industry to facilitate the development of new drugs and translate basic discoveries into treatments, the benefits of academic-industry relationships far outweigh the risks. Additionally, it is evident that bringing new drugs and treatments to patients allows industry and academia to maintain trust with patients, although we agree with Dr. Lo that strong COI policies should be in place to maintain program integrity.  

 

In the end, working in collaboration with industry has helped physicians find the solutions to tackle difficult and complex problems in their roles as clinicians and researchers. Consequently, using these skills to help improve COI policies should only be undertaken if it does not impede such collaboration.

MedPAC to Discuss New Funding Priorities for Graduate Medical Education

Expanding on their June 2009 Report “Medical education in the United States:

Supporting long-term delivery system reforms” The Medicare Payment Advisory Council (MedPAC) a non partisan governmental advisory council to congress is meeting on Thursday March 4^th at 3:45pm to discuss the role of Medicare funding of graduate medical education.  The session titled “Restructuring Medical Education Financing: Principles and Priorities” will be addressing both direct and indirect funding models and overall restructuring of funding GME through Medicare. 

 

According to MedPAC staff, they are not recommending changing the total amount Medicare gives to GME, just alternative structures for implantation of the funding.

 

The format for MedPAC meetings is the staff presents the current system, reasons for change and proposed changes.  After that the panel discusses potential changes to the slide presentation.  At end from 5:55pm – 6:00pm the public can provide brief input (5 minutes).  The public can also submit comments  up to one week after the meeting via the Web to MedPAC.

Date: Thursday March 4^th

Time: 3:45pm – 6:00pm

Location:   Ronald Reagan Building,

The International Trade Center,

1300 Pennsylvania Avenue, N.W.,

Washington, DC.

 

 

About MedPAC

Link to March 4^th Meeting Agenda

Meeting Brief:  Restructuring Medical Education Financing: Principles and Priorities

MedPAC Members

To Send Comments:  Click here  

MedPAC June 2009 Report: “Medical education in the United States:

Supporting long-term delivery system reforms”

 

Residency Programs Benefit From Industry Support

 

A recent article published in The Archives of Internal Medicine examined the affect that pharmaceutical industry interactions have on the attitudes and behaviors of medical residents. It would seem however, that such attitudes and behaviors are minimally affected by such interactions because the American Medical Association, the Association of American Medical Colleges, the Accreditation Council for Graduate Medical Education and the American College of Physicians all have issued guidelines for appropriate relationships between physicians and the pharmaceutical industry.

 

Still, the authors of the study set out with the objectives to assess (1) the current attitudes of program directors regarding pharmaceutical industry support of internal medicine residency program activities, (2) the practices of internal medicine residency programs with regard to acceptance of industry support, and (3) potential associations between program characteristics and the acceptance of industry support.

 

The Study and Results

 

The authors sent an e-mail notification in November 2006 with a program-specific hyperlink to a Web-based questionnaire to each of the 381 member programs of the Association of Program Directors in Internal Medicine. E-mails were also sent in December 2006 and January 2007. The emails asked residency program directors whether their programs accept support of any kind from the pharmaceutical industry. (This is research?)

 

Those who responded yes were asked to identify specific forms of support, including food for conferences, educational materials, office supplies, drug samples, and unrestricted educational funds, as well as types of industry involvement, such as direct contact with residents (off-site and on-site). Program directors were also asked why the residency program accepts pharmaceutical support. Information regarding the residency programs (e.g. sponsor type, ownership of the hospital, etc.) and program director characteristics (e.g. rank, salary, etc.) were also gathered.

 

Responses were categorized into a group that thought industry support of residency was “never acceptable,” support was “not desirable and should not be accepted in any case,” “desirable and should be encouraged” or “not desirable, but acceptable when other sources not available.” 236 program directors (61.9%) responded to the survey with the following results:

 

- 55.9% reported accepting support from the pharmaceutical industry;

- 72.0% expressed the opinion that pharmaceutical support is not desirable;

- Residency programs were less likely to receive pharmaceutical support when the program director held the opinion that industry support was not acceptable;

- The New York Times noted that “69.7% of the directors who reported taking industry money was due to inadequate financing from other sources;

- Other reasons to accept support included popularity with residents (40.9%), important educational value other than financial support (28.0%), ease of attainment (26.5%); and being encouraged by the department chair or administration to accept the support (19.7%); 59.8% indicated more than 1 reason for accepting industry support;

- The most common forms of industry support included food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%);

- Among programs that accept industry support, many reported allowing direct off-site contact with residents (74.2%) and more than one-third reported direct on-site contact (40.2%); and

- 15.7% of all responding program directors reported acceptance of industry support because of its nonfinancial educational value.

 

To the surprise of the authors (although not ours), “153 programs (64.8%) had established formal written guidelines (which had doubled since 1990), and 29.2% had implemented a specific curriculum to educate residents on these interactions.”

 

Overall, the authors found that although support from “the pharmaceutical industry remains common among internal medicine residency programs, it has decreased substantially from 88.6% in 1990 to 55.9% of the current programs.

 

Discussion

Interestingly, in discussing their own findings the authors cite earlier studies, which showed that “the majority of residency program leadership indicated that the benefits of pharmaceutical company representatives outweighed any negative results.” So what exactly has changed since these earlier studies? Since the AMA, AAMC, ACP, and ACGME all have implemented policies to maintain industry interactions and 65% of programs have guidelines and 30% have specific curriculum, it seems like the authors concerns are unnecessary.

The authors even go on to cite another study which showed that “residents often do not believe that their own actions are influenced by industry contact or gifts.” This kind of evidence seems to contradict any kind of belief that residency programs with industry funding are doing something “wrong,” especially as the authors also acknowledge that “residency programs have sought to address this potential conflict of interest through the development of curricula and guidelines that outline appropriate residency industry interactions.”

 

Another piece of evidence that the authors downplay is the fact that two-thirds of the 55.9% of program directors who accept industry funding do so because of inadequate funding from other sources. As a result, the authors should have recommended that further study is needed to determine where such funding would come from if industry interactions with residencies are eliminated, and the impact it would have on medical training and patients.

 

The fact that industry support is a “readily available funding source for specific activities” is reassuring for many doctors who have huge debts to pay and need the training, as well as academic medical centers and hospitals who need the support. In fact, the authors showed that “the most commonly cited use of industry funding was for provision of food at conferences or educational activities, a strategy that has been shown to boost conference attendance.” If industry funding gets more residents to participate and learn about how to treat patients, aren’t we all winning?

 

Conclusion

 

We agree with the authors that residency “program leadership may have the best opportunity to further define appropriate industry residency interactions.” In order to use this leadership, programs must recognize that the quick availability of industry funding when other sources are non-existent will almost certainly make the difference in hundreds of patients of lives someday very soon.

 

The limitations of this study are concerning because the authors noted that “the degree to which programs rely on pharmaceutical funding for residency activities requires clarification.” The study also was not designed to “demonstrate a causal relationship” between industry funding and residencies. As a result, because the study acknowledged that “all of the underlying reasons are not yet fully elucidated” regarding industry interactions with residents, further research is indeed needed into the relationships between professionalism and training environments where pharmaceutical support is accepted.

 

Moreover, since policies “set boundaries for what the individual institutions believe are appropriate” for interactions with industry, it must be up to the programs, administration and directors to educate trainees who “are often unaware of the position of their own institution.” Educating residents—which is what they are there for in the first place—on interactions with industry is crucial, otherwise when they get into practice they will have no experience dealing with industry one way or another.

UCSF Study Shows Absence of Bias in Commercially Supported CME

 

Michael A. Steinman, MD, et al., recently examined the “Commercial Influence and Learner-Perceived Bias in Continuing Medical Education.” The article, which appeared in the Journal of Academic Medicine, examined the relationship between commercial support of continuing medical education (CME) and perceived bias in the content of these activities.

 

Research

 

The research collected data from 213 directly sponsored live CME activities hosted by the University of California, San Francisco (UCSF) Office of Continuing Medical Education from 2005 to 2007. The median number of participants per course was 132.

The breakdown of CME activities included one third (73, or 34%) of courses with no commercial support, with the remaining courses split between varying levels of commercial support. One hundred seventy (80%) activities were considered at lowest risk of commercial bias based on the UCSF Office of CME’s risk rating system, 36 (17%) were considered intermediate risk, and 7 (3%) were considered highest risk.

Commercial support covered only 20%–49% of costs for 45 (21%) of the educational activities, and only 50% of costs for 46 activities (22%).

 

A standard question from course evaluations was used to determine the degree to which attendees believed commercial bias was present. At the completion of CME activities, participants were asked to evaluate several characteristics of the activity, including an overall rating of the course (using a five-point Likert scale) and a question about whether the activity was free of commercial bias (answered with a yes/no response). The study also evaluated other factors such as whether the activity chair had ties with industry or whether registration fees were below market value.

 

Findings

 

Overall, the data indicated that “the vast majority of CME activities were perceived by participants to be free of commercial bias.” Findings included:

 

- The perceived overall quality of CME activities was high, with a mean rating of 4.4 on a five-point Likert scale;

 

- Few course participants perceived commercial bias, with a median of 97% of respondents stating that the activity they attended was free of commercial bias;

 

- There was no association between extent of commercial support and the degree of perceived bias in CME activities; and

 

- Perceived bias did not vary for 11 of 12 event characteristics evaluated as potential sources of commercial bias, or by score on a risk index designed to prospectively assess risk of commercial bias.

 

Discussion

 

Although criticisms have continued to grow over the past few years regarding commercial support for accredited CME, these concerns are misguided as yet another study shows. Moreover, “many organizations including the Accreditation Council for Continuing Medical Education (ACCME) and the Association of American Medical Colleges, have chosen to preserve commercial support,” a signal showing the importance of defending this relationship. In fact, these organizations support the continued funding of CME by industry while simultaneously “adopting increasingly more stringent regulations designed to limit the influence of industry funding on the content and objectivity of CME,” thereby negating any potential concerns.

 

In addition to the efforts of the previously mentioned organizations, non-profit providers of CME, such as academic medical centers (AMCs) and professional organizations “have adopted screening processes to identify activities at high risk of commercial influence,” including UCSF, as is described in the study.

 

Another source of evidence to silence critics of industry funded CME are the attempts made by the Consortium of Continuing Academic Medical Education, who have recently developed standardized instruments to predict bias in CME. Such tools are crucial in identifying potentially high risk of commercial bias in CME, while still preserving courses and funding. Consequently, these tools, and the evidence from UCSF’s study gave the “direct interpretation that CME activities in general are free of commercial bias.”

 

Limitations

 

Dr. Steinman et. al, noted a few limitations in their study, such as the UCSF Office of CME rejecting proposals with a single industry supporter or those with no cost to the participant. As a result, the authors noted the screening process may have weeded out CME activities at higher risk of commercial bias, leaving only activities in which commercial bias was more subtle or entirely absent. Such a limitation is not troublesome because many critics of industry funded CME believe that programs with subtle bias are the hardest to discern for that very reason.

 

UCSF’s screening process to include CME activities may have also subjected to some programs to mitigation procedures before and/or during the activity. The authors also felt that using a simple “yes/no” question to assess learners’ perceptions of bias may have been a weakness. This suggestion is also unnecessary because the result gives highly trained doctors and attendees a clear answer, not a scale.

 

Conclusion

 

While the authors contend that their data shows the difficulty of detecting commercial bias in CME, their recommendation to safeguard against industry is not needed. Since their data shows that “the UCSF Office of CME’s screening practices resulted in a series of CME programs with little if any bias,” how could they contradict such results?

 

The fact that such a large number of programs (213) “were perceived by participants to be free of commercial bias,” suggests that CME programs at UCSF are maintaining the best kind of programs with physician’s while preserving collaboration with industry. Moreover, because “rates of perceived commercial bias were consistently low regardless of the presence or absence of risk factors for commercial bias,” any criticisms of industry-funded CME (at least at UCSF) are negated by this study.

 

Additionally, because the rates of perceived bias also “did not differ by the degree of industry support or other event characteristics,” the level of funding and involvement of single or multiple sources of funding from industry should no longer be a concern, as long as all ACCME standards and rules are followed.

 

Ultimately, while the authors recommend that more research “is needed to systematically investigate the presence and impact of bias in CME, including in-depth explorations of course content and learner perceptions of bias,” their present study nonetheless is a great starting point for maintaining industry funded CME. With the continuing trend of studies showing that industry funded CME programs have low rates of perceived commercial bias, and that commercial support does not result in perceived bias in CME activities, it seems like people are starting to recognize the important collaboration that industry and medicine have.

 

University of South Florida: Nobel Prize Winner Lectures on Working with the Pharmaceutical Industry

Many medical schools are running away from industry, but one university is embracing the outcomes of working with Industry.  The Dean of the University of South Florida is hosting on March 4^th Nobel Laureate Alfred Gilman, MD, PhD in a lecture titled:

USF Deans Lecture

Why is Everyone Picking on the Pharmaceutical Industry

And Yes, I have a Financial Conflict of Interest

A pro and con discussion of the pharmaceutical industry’s current status,

Including consideration of public affairs issues

Cocktail Reception: 5:00pm-7:00pm

Lecture: 7:00pm-8:00pm

Sponsored by USF Health

In addition they are also holding a panel discussion on the important topic of transparency and objectivity:

Tenth USF Symposium on Bioethics Conflicts of Interest

Balancing Entrepreneurship with Objectivity and Transparency

University of South Florida Discussion with Alfred Gilman, MD, PhD

Panel Discussion: 3:00pm-5:00pm

Jointly Sponsored by

USF Division of Research Integrity & Compliance &

USF Bioethics and Medical Humanities

Registration

For more information and to register visit

  

No registration fee for these activities.

Registrations must be received by March 1^st

About Lecturer:

Alfred Gilman, MD, PhD

1994 Nobel Laureate in Physiology or Medicine

Alfred G. Gilman, MD, PhD co-founded Regeneron Pharmaceuticals, Inc and is currently the Chief Scientific Officer of the Cancer Prevention and Research Institute of Texas.

He served as Executive Vice President for Academic Affairs and Provost at the University of Texas Southwestern Medical Center in Dallas as well as Dean of Southwestern Medical School. Dr. Gilman is an American biochemist who shared the 1994 Nobel Prize in Physiology or Medicine with Martin Rodbell for their discovery of G-proteins and their role in signal transduction within the cell.

He received a Bachelor of Science degree summa cum laude in Biochemistry from Yale University and his Doctor of Medicine and Doctorate in Pharmacology degrees from Case Western Reserve University in Cleveland, Ohio.

Dr. Gilman has been the recipient of many awards including the American Heart Association Basic Science Research Prize in 1990, American Cancer Society Medal of Honor in 1995, Albert Lasker Basic Medical Research Award in 1989, and The Gairdner Foundation International Award in 1984.

 

Partners Policy Stifles Innovation

A recent article in Harvard’s Crimson examined the newly announced changes in Partners’ Conflict of Interest Policy, and how some doctors are concerned about the policy’s reach. We previously wrote that one physician has already resigned because of the new policy.

The article mentioned Harvard Medical School assistant professor Paul M. Copeland gives industry-sponsored talks each year, and heads the endocrinology division at Partners Healthcare-affiliate North Shore Medical Center. He specifically stated that he does not do such talks for the money.

He told the Crimson that “these information sessions—or “talks for docs”—improve patient care, and all the material he presents has been approved by the Food and Drug Administration.” Unfortunately for Copeland, he can no longer register for the 2010 speaking cycle because of Partners new policy.

As we have previously explained, the revised policy puts restrictions on Partners employees, “including bans on speaking at industry-sponsored events and receiving stock options from pharmaceutical companies. Outside pay for senior officials sitting on boards of drug or medical device-making companies has been capped as well.” The policy considerations began in the fall of 2007, when “Partners Healthcare embarked on a conflict of interest review to better define the relationship between industry and medicine as well as strengthen oversight of physician activity with drug companies.”

Regarded as one of the strictest policies in the nations, “some Partners employees caution that the new restrictions may be too broad and could ultimately stifle essential physician activity.” Specifically, Dr. Copeland asserted that continuing medical education (CME) talks sponsored by drug companies “provide doctors with the latest information on treatments, address patient care issues, and educate physicians about the proper role of medications.” Under the new policy, doctors will be losing this valuable information, and will be forced to receive information elsewhere (where and from who?), and sometimes at a great inconvenience.

He further noted that at CME programs “he regularly fields an hour’s worth of questions from doctors who attend his talks about case studies and alternative treatments.” As a result, Dr. Copeland believes the new policy is so “disheartening” because “Patients and doctors benefit from these talks, and the policy will “have detrimental effects on physicians’ activities, such as continuing medical education.”

The article also cited Medical School professor David B. Acker, who is also chief of obstetrics at Brigham and Women’s, who supports the new policy and believed it came late. In addition, Medical School professor Charles N. Serhan, who served on the committee that issued the policy recommendations, also applauded the policy’s aims to rein in conflicts of interest issues, but he “cautioned that its expansive reach does not come without costs.”

As a member of the committee who issued the recommendations, he told the Crimson that as a result of the policy, “the pendulum is a little too far in one direction in that our rules are now too tight and could actually stifle innovation.” Consequently, Dr. Serhan asserted that “with time, the policy has to come back to some equilibrium.” Such comments are problematic as a member of the committee itself admits the new policy to be extreme.

Mass. General’s chief surgeon Andrew L. Warshaw also noted his concerns with the new policy in regards to “certain initiatives such as surgical fellowships, which are generally dependent on industry funding. He noted that although he understood the goals of the policy, the impact may cause these fellowships to “suffer from the crackdown on outside funding.” He further gave the example of a general surgeon who wanted to learn minimally invasive techniques, a scenario that is commonly funded by outside interests, and asked: “Is it a bad thing when someone gets training that they wouldn’t normally get and helps patients?”

Another clinical professor at the Medical School, Barry W. Levine, who has worked at Mass. General for four decades, “says he is still figuring out how the new policy will impact his profession.” Dr. Levine’s experience consists of 18 years of speaking about lung disease on behalf of drug companies like AstraZeneca and GlaxoSmithKline. He told the Crimson that “he does not plan to take on any more speaking engagements until the implications of the policy become clearer.”

Like Dr. Copeland, Dr. Levine believes “the new regulations stymie critical education about asthma and emphysema for doctors in underprivileged communities.” For example, “he routinely meets physicians who do not have access to pulmonary function machines, which are critical for diagnosing these diseases.” Dr. Levine firmly believes that such meetings are not promoting a drug. He also added that “the drug companies sponsoring the talks he participates in have no power to censor what materials physicians present, as long as the information has been approved by the FDA.”

As other physicians and institutions consider the effect of this policy and alternatives, committees should consider answering the following question presented by Dr. Copeland: “Is it a bad thing when someone gets training that they wouldn’t normally get and helps patients?” In answering that question, committees should recognize that regardless of the source of funding, the training will help patients.

Ultimately, the growing concern among doctors at Harvard and at Partners regarding the new conflict policies will have to resolve the difficult question of maintaining the necessary relationship between industry and medicine without distorting physician incentives. As is evident from the doctors cited above, the current policy places restrictions that “may be too broad and could ultimately stifle essential physician activity.” Moreover, as one of the committee members who created the policy himself stated, bringing the policy back to “equilibrium” now is critical before it stifles innovation.

Universities, Bayh-Dole: Rules and Regulations – Don’t Throw the Baby Out with the Bathwater

A recent editorial “Don’t Throw the Baby Out with the Bath Water” from Mark C. Rogers, M.D., M.B.A., former anesthesiologist-in-chief at Johns Hopkins and Editor-in-chief of the journal, Medical Innovation & Business notes that the whole purpose of the Bayh-Dole Act has been forgotten. The act, which gave the ownership of intellectual property discovered under government-sponsored research grants back to the university and the scientists who had gotten the grants, was to specifically encourage commercialization in the interests of expanding our national economy. 

Although he thinks that commercialization of biotechnology is misplaced at a university, he notes there is an important balance to maintain because of the “underlying clinical and economic importance of biologic discoveries that occur in universities,” a product of the Bayh-Dole Act. As a result, he proposes that to maintain this balance, universities need adequate standards and supervision of commercialization. Without such guidance, Dr. Rogers does not want to “risk stifling the process and even driving inventive faculty to other universities with more appropriate standards for commercialization.”

His experience however, tells us that university officials are not always prepared to take on such endeavors. Consequently, he asserts that universities should carefully consider the “role that entrepreneurial driven commercialization can play in a university if properly managed instead of shut down.” He emphasizes this role due to the diminishing medical reimbursements that universities are seeing, smaller university endowments, and reduced funding at the NIH.

Ultimately, Dr. Rogers does not want universities to become obsessed with creating complex rules and regulation that “effectively stifle entrepreneurial mentality and neuters the potential for commercial success with university-sponsored research.” In agreement with his contention, universities, Congress, and health related agencies should re-evaluate the importance of the Bayh-Dole Act and go back to its original intent of bringing medical advances to the public in a timely manner through the collaboration and mutual benefit of industry, government and academia.

Eli Lilly’s William Chin to Head Harvard’s Research

While the growing trend with medical schools and hospitals around the country are to develop policies that “minimize the potential influence of the drug industry on medicine and medical education,” Harvard Medical School is taking a stance that developing therapies is a more important mission.

Harvard “appointed a new research chief who spent the last 10 years at a pharmaceutical company.” Although several of the hospitals associated with Harvard recently came out with new policies regarding interactions with industry, this new appointment is an important breakthrough in emphasizing the critical role academic-industry collaboration can play in research and development. In fact, Harvard’s Medical School Dean Dr. Jeffrey S. Flier noted that “skills from both academia and industry are needed.”

The new research chief, Dr. William W. Chin, a molecular endocrinologist, who graduated from Harvard Medical School and trained at Beth Israel Hospital and  Massachusetts General Hospital, will become executive dean for research. The newly created position “will have oversight of biomedical research at the school and work with Harvard-affiliated hospitals as well as Harvard University on strategic scientific planning.”

Dr. Chin will begin his new role at Harvard on May 1, 2010. Before joining Harvard, Dr. Chin worked for “Eli Lilly and Co., where he is senior vice president for discovery research and clinical investigation. He joined Lilly in 1999 after 25 years on the faculty of Harvard Medical School and Brigham and Women's Hospital.”

In applauding Dr. Chin’s work history, Dean Flier noted that "There are very few people capable of rising to such a challenge.” But not everybody is as happy about the appointment.

The Boston Globe also quoted Dr. Arnold S. Relman, professor emeritus of medicine and of social medicine at Harvard and former editor-in-chief of the New England Journal of Medicine, called the appointment “puzzling.” He associated the appointment with a sign that “Harvard Medical School intends to even further strengthen its research ties to the pharmaceutical industry." Such an assertion is misguided because Dr. Chin is a highly qualified and experienced researcher, and his experience with industry has only distinguished his knowledge.

Dr. Relman is worried that by this appointment, “people will worry that the separate roles for academic medicine and drug companies are becoming more confused, leading to more conflicts of interest." This worry is also misguided because Harvard “is developing a new policy to guide interactions between researchers and the drug industry,” and has already installed new policies to monitor conflicts of interest.

Dr. Relman’s comments expose how rabidly anti industry and out of touch with research and medicine he has become.    This is by no means meant to take away from Dr. Relman’s many accomplishments, but sometimes as we get father from the day to day realities of medicine we drift into tangents.

Can one imagine an article critical of the hiring of the Chief Technology Officer of Microsoft  Ray Ozzie to direct research at  Massachusetts Institute of Technology  (MIT) that would be critical of him because they “worked in industry”?.  It would be a considered a ridiculous stance for a semi retired professor at the university to take.  MIT would by shouting from the rooftops and ringing the bell for such a hire. 

As was the case with President Obama—who when first elected said he would hire no lobbyists, and then issued waivers for various administration officials with ties to industry—Harvard realized that work with industry is crucial for enhancing research.

Also applauding the appointment of Dr. Chin was Dr. Lee Nadler, dean of clinical and translational research at the medical school, who first met Dr. Chin in 1969 when he was a first-year medical student.  Dr. Nadler asserted that “except for Jeff Flier, Dr Chin is the most important recruit to Harvard Medical School" because he will bring skills from the two worlds of academic medicine and industry.”

Dr. Nadler further disputed Dr. Relman’s concerns because what Dr. Chin learned with industry, is “what it takes to move basic science to impact patients.” He further emphasized that the medical school “hired Dr. Chin to knock down those blocks” that impede bringing science to patients.” In describing Dr. Chin’s motivations for medicine, Dr. Nadler also noted that he “only cares about our patients and their families, not about the drug companies, it's about people with illness."

We applaud Harvard’s decision, and hope that many other medical schools can recognize the important experience gained from potential faculty and staff by working with industry.

 

Partners Health Care: Policy Implementation on CME

In a roll out of their conflict of interest policy, Partners Health Care (several hospitals serving Harvard University) recently announced “changes pertaining to industry support for medical education throughout the Partners organization.” They specifically noted that some of these changes became effective on January 1, and others become effective on May 1, 2010.

Part of the changes included a newly created “Education Review Board (ERB) responsible for approval and oversight of all industry gifts supporting educational programs and activities in Partners hospitals.” The board consists of members from the clinical, scientific, education, and patient advocacy communities and, to our knowledge, it is the only one of its kind in the nation. A list of the ERB members is on their website.

Regulations that became effective January 1, 2010, included a review by the ERB of “specific industry-supported proposals which until now have been carried out by a subcommittee of the Partners Education Committee (PEC).” Partners noted that the “will continue its valuable role of review and approval of Graduate Medical Education programs sponsored by Partners hospitals.”

Pat of the changes included reviewing all agreements for industry support of educational programs and activities through the Office for Interactions with Industry, rather than hospital development offices.

Regulations that become effective May 1, 2010, include using the ERB to ensure that all industry support of educational programs meets these Commission-recommended requirements:

-   funding for a specific program or activity must come from more than one company;

-   any continuing medical education program that involves conferences or lectures, or other forms of presentations, must meet Accreditation Council for Continuing Medical Education or comparable standards (as determined by the ERB), whether for CME credit or not;

-   a more rigorous process to screen potential conflicts of interest and monitor content of programs will be applied.

Partners noted that these new policies represent a “cultural change” that will take “time, thoughtfulness, and a sustained commitment from the entire Partners community.” The Partners Office for Interactions with Industry, which administers these policies, has developed FAQ's on the website.

Partners Physician Resigns Over Speaking Ban

The Boston Globe outlined the choice of a physician to leave a top Harvard teaching hospital, after the hospital adopted a policy restricting speaking for pharmaceutical companies.

Lawrence M. DuBuske, MD an allergy and asthma specialist and a Harvard Medical School instructor, announced he will resign from Brigham and Women’s Hospital and Harvard at the end of the month after 20+ years. 

The hospital said. Dr. DuBuske, also runs a Gardner-based nonprofit organization called the Immunology Research Institute of New England, which sponsors education programs for doctors in Eastern Europe, according to its website. He speaks Russian, has published dozens of articles, and in 2004 won the Distinguished Fellow Award of the American College of Allergy, Asthma and Immunology, according to his and the Brigham’s websites.

According to the article, Dr. DuBuske was highly compensated for working with companies and during a three-month period last year, he earned $99,375 for giving 40 talks to other physicians last April, May, and June, almost one every other day.

This breaks down to approximately $2,500 per day, probably less than the amount of money a physician would earn in one day for seeing patients.

The article also noted that Dr. DuBuske works for six other pharmaceutical companies as a speaker, and he is a consultant for a half-dozen drug makers.

The reason DuBuske is leaving the hospital is because his extensive speaking for drug companies is “now in direct violation of a strict new conflict-of-interest policy for the Partners HealthCare hospital network, which includes the Brigham.” There was also one doctor, from McLean Hospital, that resigned because of the new rules that went into effect January 1, 2010.    

Mary Anne Rhyne, US director of media relations for Glaxo, noted that “the company picks the topic and content of the talks in the speakers bureau program.”

Consequently, with “more teaching hospitals restricting or banning participation in speakers’ bureaus, it is unclear whether drug companies will cancel talks or turn to doctors without academic appointments, who are outside the rules but may not draw as big an audience of fellow physicians.”

Hospitals and health care institutions that are creating these policies are worried that physicians who “give company-sponsored talks may present biased information that could underplay harmful side effects or may encourage use of expensive brand-name medications instead of less costly alternatives.”

They should be more concerned at the potential long term detrimental effect these types of policies can have on recruitment and retaining top tier faculty.   What may seem like a good idea today (banning everything without providing additional income, and limiting physician interaction with community physicians no matter who pays for the interaction) may have serious long term consequences on the quality of patient care both inside their institution and to the community.

In response to these policies, physicians such as Dr. DuBuske assert that doctors “who participate in speakers’ bureaus carefully screen the information for accuracy, and some doctors argue that working for numerous companies, cancels out bias in favor of any one drugmaker.”

In fact, Dr. Paul Appelbaum, director of psychiatry, law, and ethics at Columbia University College of Physicians and Surgeons, said that even though bias can be subtle, “it is possible to take money from a pharmaceutical company and deliver an unbiased talk.”

It should also be noted that the types of presentations that are specifically funded by drug companies are very different from continuing medical education (CME) programs. Presentations that are fully funded by industry are primarily different from certified CME programs because the company controls the content, whereas CME providers control the content even though manufacturing companies can provide educational grants.

Regardless of who sponsors the event, physicians must hear a variety of information from various sources so they can be aware of the newest breakthroughs and research to treat their patients with.

The fact that hospitals and institutions are restricting the involvement of physicians from speaking at these events will hurt other physicians who could learn from these experiences and share them with their patients. Hospitals and academic institutions need to understand that not every interest or working relationship constitutes a conflict, and that physician’s activities with industry represent a multiplicity of interests.