Policy and Medicine

Letters to the Editor: Conflict of Interest in Authorship, and Disclosure in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals

 

Last year, Laurence J. Hirsch, a former spokesman for the pharmaceutical manufacturer  Merck, wrote an 11-page commentary titled Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals. The article, which looked at the relationship between medical journals and physicians who work on behalf of trial attorneys was published by the journal Mayo Clinic Proceedings, along with a correction and was also accompanied by a editorial by William L. Lanier, the publication's editor in chief.

In response to the commentary, Mayo Clinic Proceedings received a large number of letters to the editor and other communications in response to the commentary by Hirsch and the accompanying editorial by Lanier. Below is a summary of the comments the journal received .

 

Jeffrey R. Garber, MD, President of The American Association of Clinical Endocrinologists (AACE) acknowledged the various “interests” that physicians have and stated that “there is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable, and beneficial.”

 

Dr. Garber further emphasized that “monitoring and regulating physician interaction with industry is the key to ensuring integrity has yet to be supported by balanced scientific evidence.” As a result, he supported Hirsch’s “cogent argument that disclosure requirements for journal editors who are entrusted with accepting or rejecting manuscripts or who publish their own manuscripts should be as rigorously scrutinized as those being aggressively promoted for the medical community at large–perhaps no more, but certainly no less.”

 

Patricia K. Baskin, MS Executive Editor, Neurology, along with her colleagues, criticized Hirsch’s article for misrepresenting the “importance of the intellectual contribution of first drafts of manuscripts.” They make this claim based on the assumption that “a common industry practice is to use a professional writer to generate a first draft of a manuscript to facilitate the engagement of a “guest” academic author.” In fact, the editors of this journal felt that Hirsch’s essay showed a “desire to cover up the work of professional writers.”

 

In response to their criticism, Dr. Hirsch noted that there was no suggestion of cover up of authors but rather, that “others often do less and should simply be acknowledged, case-by-case.” As a result, he concurred that the contributorship model of attribution may be preferable to current approaches” but, “whether one approach is “better” than the other remains to be seen.”

 

One of the more powerful comments in support of Hirsch’s article came from numerous clinical researchers and educators dedicated to the treatment of multiple myeloma. These physicians wrote their response because they recognized that one important factor has been missing from the discussion about the increasing scrutiny and regulation of the relationship between clinical educators and investigators and industry and the continuing medical education (CME) providers:

 

“a concerted response from those who have worked with the pharmaceutical industry and providers of CME to present the opinion that these interactions are in fact of real value.”

 

These clinicians are also worried about the valuable relationship of industry and CME because “evolving institutional and national trends now in the public domain may seriously curtail the interactions between clinical educators and investigators, industry, and CME providers.” If such interactions are prohibited or hurt, they assert that it “will diminish clinical investigation and education alike, with a consequent negative effect on patient care.”

 

Even more detrimental to patient care, the group noted, is that “many institutions are considering the adoption of a “zero involvement” policy, which would substantially limit physician involvement in CME activities and new drug development.” They noted that “although some rare abuses have occurred and that the risks in this interaction are real,” the medical community should avoid “overzealous, ill-judged, and restrictive regulations that will curtail the current constructive interaction.”

 

Specifically, clinicians emphasized that such partnerships “resulted in unprecedented advances in myeloma, with a subsequent dramatic improvement in patient outcome, and to impede this progress in the treatment of multiple myeloma would be a disservice to their patients and their families.” The group then went on to assert that:

 

1.   Synergistic interactions between physicians and the pharmaceutical industry have contributed to the development of safe and effective therapeutics that have improved individual patient outcome and thus have contributed to the greater good of society.

 

2.   The overwhelming majority of interactions between academia and industry have been positive, productive, ethical, mutually respectful, and driven by the shared desire to bring better treatments to patients with multiple myeloma.

 

3.   Conflict of interest concerns in these relationships have been exaggerated and diminish the integrity of physicians and coworkers engaged in clinical research in the public eye.

 

4.   The evidence points to the overwhelmingly positive aspects of clinician-industry interaction and that a “confluence of mutual interest” exists.

 

5.   That industry-academia interactions, conducting shared research under commonly agreed upon guidelines characterized by full disclosure and clear transparency, are in the best interests of all, and in particular our patients.

 

6.    Enforced disengagement of such partnerships will help no one and hurt many.

 

7.   The support provided by industry for professional meetings and publications designated to promote and foster research as well as education is a major factor in contributing to the clinical development and subsequent deployment of effective therapies in a timely manner.

 

8.   The support provided by industry to commercial CME providers, with independent review of content for fairness and balance, has resulted in the development and implementation of a variety of educational events directed toward physicians, patients, and allied health care personnel, which has improved their understanding of the disease, the benefits and risks of different treatment strategies, and the existence of additional resources to help in patient care. Through these educational events, the quality of care delivered to patients with myeloma has improved. By accelerating deployment of new therapies, lives have been prolonged and toxicities of treatment decreased.

 

9.   We believe that this learning activity is of high value to the recipients of such education, especially to patients. As such, remuneration to experts of content and presentation for their time (often spent away from family) is reasonable, necessary, and professionally acceptable.

 

10.   Consulting and participation in advisory boards by highly informed specialists with first-hand experience of novel therapeutics, both clinically and  preclinically, are important activities of high value to industrial partners during the development of safe and effective new drugs. Optimal sharing of this knowledge occurs with investigators who care for patients and are engaged in clinical research, thus representing a bona fide exchange of information; remuneration for this work is reasonable, necessary, and professionally acceptable.

 

One commentator recommended that a 10-year moratorium should be used for any expert who would sit on FDA or related advisory committees and severing all financial ties at least 2 years before volunteering for these committees through 5 years after the guidelines have been implemented. In response, Dr. Hirsch noted that such an idea is “precisely the kind of damaging forced disengagements between industry and physicians, academia and medical associations that Fonseca et al warn against and which are not supported by analyses of several hundred Food and Drug Administration Drug Advisory Committee deliberations.”

 

Joseph S. Ross, MD, MHS, of Mount Sinai School of Medicine, and Harlan M. Krumholz, MD, SM, of Yale University School of Medicine, also commented on Hirsch’s article, and criticized him for misstating facts. Hirsch defended his assertion about Ross and Krumholz’s articles because “there was no mention of any of the authors being compensated, nor of appearing as expert witnesses in court, etc. The disclosure statements in the 2 other publications mentioned that the authors had been compensate.” Dr. Hirsch did note a correction to a statement about compensation.

 

A clinician who treats patients with AIDS commented that “had great opportunity for profit not motivated the owners of these companies, AIDS drugs may never have been developed.” He further emphasized that “had the owners of these companies not paid the researchers adequately, they may not have been able to retain and engage the type of people who have led to these wonderful breakthroughs and advances in drug developments.” Consequently, he referred to the present trend as an evolving “witch hunt against pharmaceutical companies.” He called for judging the work of physicians and researchers on the “basis of what they do and what they accomplish, not on the basis of who pays them or how they are paid; on the basis of its quality and honesty, not by who writes the paycheck of the investigators.”

 

Conclusion

 

In the end, Hirsch acknowledged that he had received dozens of e-mails from readers in the United States, United Kingdom, Europe, and Latin America after publication of his commentary and Dr Lanier’s editorial. He noted that, “with a single exception, roughly 90% were supportive.” As a result, he asserted the need to stop the indiscriminate use of the term “conflict of interest, and instead use the more neutral term “competing interests.” Dr. Lanier added that, the overwhelming majority of communications were supportive as well. In fact, he noted that many comments dealt with the fact that journals, editors, and policy makers were using a one sided idea dealing with the ills introduced by financial COI, instead of discussing the larger “risk-benefit equation as it relates to the discovery, invention, and introduction of drugs and medical devices.”

 

Such support reaffirms the notion that “within the proper boundaries of full disclosure and compensation at fair market value for the effort involved, these interactions should not be limited, but rather encouraged with appropriate guidance and within agreed upon guidelines.” Moreover, the relationships with industry and physicians should be strengthened to further improve outcomes for patients,” because hindering the progress of such collaboration will only be to the detriment of all, in particular patients.

 

It is also important to remember that “we should not simply assume that because someone is paid either more or less or by one person or another person, that the quality of his or her work or his or her integrity is either better or worse.”

 

With that in mind, we agree with Dr. Lanier that “the long-established, sustaining principles of scientific method, peer review, and medical publishing do not need to be abandoned or undergo major revision in the current era … because these traditional rules can be used appropriately for the advancement of knowledge and the benefit of society.” In fact, “collaborations with industry by experienced clinicians, educators, and researchers are indeed beneficial and advance the state of health care.”

 

Rather than “close the door to evidence, debate, and proper decorum,” by excluding the involvement of industry and “mocking the core of science,” the medical community and public must “appreciate the enormous amount of high-quality research funded by industry to develop drugs and demonstrate their value.”

State Policy: New Jersey Senate Committee Passes Conflict of Interest Restrictions on Hospitals

 

Last week, the New Jersey Senate Health, Human Services and Senior Citizens Committee approved a bill—S-369—that  will “require New Jersey hospital boards of trustees to adopt a policy regulating conflicts of interest (COI) on the part of hospital board members.

State Senator Loretta Weinberg (D-Bergen), and Senator Robert M. Gordon co-sponsored the proposal. Senator Weinberg emphasized that this “legislation would ensure that the members of these boards are working to enhance the health and quality of life of patients, and not to pad their pockets or pensions."

The proposed legislation would require hospitals to then post their policies on their web site. Hospital COI policies “would include language requiring disclosure of any perceived or actual conflicts of interest by members, as well as a prohibition on members voting on or discussing any contracts from which they would directly benefit.”

In addition to the disclosure, “the bill would also require hospitals to solicit a minimum of three bids or proposals, when dealing with any contract of $25,000 or more, when the contract concerns an issue that would be perceived as a conflict of interest for any member.”

Senator Gordon also noted that the legislation “would put into practice recommendations of the Commission on Rationalizing Healthcare, which was created to examine and make necessary recommendations to improve the quality and operations of the state's hospital system." Mr. Gordon added that the Commission had apparently found “a lack of transparency in state hospital operations and accountability.” As a result, he hopes that this bill will “ensure that hospitals are governed fairly, and that those who govern have the best interests of the hospital and patients as their top priorities."

Included in the bill is language which states that board members would have to disclose any perceived or actual conflict of interest on the member’s part with respect to any matter pending before the board.” Who would determine what constitutes an actual or perceived COI?  The bill does not define what constitutes a “potential conflict”  we expect that it will probably be New Jersey’s Commissioner of Health and Senior Services, an unelected, not exactly accountable bureaucracy.

After being passed in Committee the legislation will now move to the full Senate for consideration.

While it is certainly important the hospital boards fully disclose their financial relationships to avoid the appearance of or potential for conflict, this bill could have unintended consequences for hospitals in New Jersey.

The cost of running programs, treatments, medical specialty practices, as well as receiving new equipment and funding for hospitals is an extremely complex and difficult process. The relationships that boards build with industry to bring such funding are important to maintain and preserve. If a hospital is required to solicit three bids or proposals, and they cannot obtain such numbers, especially for a new medical device, the patients will have to pay, with their lives.  

The goal of the bill which is to have more transparency and fair contracting policies is a good one.  New Jersey is well known for inside government contracting.  But these rules do have a chilling effect on a hospitals ability to attract experienced talent in working with hospitals, which is a unique enterprise to say the least.

More discussion is needed to take into account how this type of bill could affect funding for hospitals and treatment for patients.

 

FDA Official Cleared of Conflict Allegations in Heparin Contamination Case

Last week Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA was cleared of a conflict of interest allegation.    The charge came from her engagement of a firm developing a low molecular weight heparin generic, to find the source of the 2008 heparin contamination.

In 2008, Dr. Woodcock, and scientists at Momenta Pharmaceuticals were among a team of researchers that identified a contaminant in Chinese-imported heparin marketed by Deerfield, Illinois-base Baxter International that was sickening and, in some cases, killing patients. According to The Baltimore Sun, the findings were reported in a pair of science journals in April 2008.

In competition with Momenta to develop the drug was Amphastar Pharmaceuticals, Inc., located in Rancho Cucamonga. Both the version of heparin under development by Amphastar and Momenta is chemically similar but distinct from the form of the Baxter drug, according to the Sun.

Problems arose in April 2009, when Amphastar raised conflict allegations against Dr. Woodcock’s work with the drug. “Amphastar alleged that Woodcock's research work with Momenta essentially forged a bond with the company and created the appearance of a conflict.” Amphastar also alleged in its complaint that “earlier contacts in 2007 between Woodcock and Momenta-connected scientists discussing issues that would later figure in requirements imposed on both companies' applications.”

Eventually, Dr. Woodcock “voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals.”

Last week however, FDA legal counsel Ralph Tyler announced that “the research collaboration between Janet Woodcock, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency.”

Mr. Tyler asserted that there was “no conflict” and that “as an act of good grace Woodcock stepped aside from any involvement in both applications last August.” In addition to this announcement, Mr. Tyler also acknowledged that the investigation by the Department of Health and Human Services Inspection General was dropped.

An attorney for Amphastar, Jason Shandell, was not happy with the announcement. He questioned the timing of Woodcock’s withdrawal from the study, and how the FDA contacted reporters before notifying his company. He asserted that that agency had handled the matter contrary to the “face of transparency” advocated by the Obama Administration.

In defending the stance of the FDA, principal deputy commissioner Josha Sharfstein told the Sun that “the agency needed to be able preserve its ability to respond to public health emergencies and also assure safety of new products.” Mr. Sharfstein further added that just because officials are involved in “both activities, does not mean they are automatically conflicted.  

Ultimately, this case demonstrates an extremely important consideration: there is a difference between conflict and confluence.  

In this case, it is clearly in the nation’s best interest that FDA officials have access to the most knowledgeable scientists to solve public health issues, and that means access to company scientists and technologies.

UK Vaccine Scare Linked to Attorney’s Payments to Physicians

A recent blog entry in Psychology Today, acknowledged that Andrew Wakefield, along with two of his collaborators, were “found by Britain's General Medical Council (GMC) to have engaged in misconduct in relation to sparking a controversy over the autism-MMR myth.” He could potentially lose his license to practice medicine.

Yesterday the Journal Lancet retracted the 1998 study linking a routine childhood vaccine to autism and bowel disease after a U.K. investigation found flaws in the research.

One of the charges against Wakefield was that “he provided a research proposal to a lawyer seeking to sue vaccine manufacturers for causing autism.” In this case, it was not a pharmaceutical company who paid a doctor to promote a drug off-label or to ‘ghostwrite’ a manuscript, rather, it was the litigators trying to deepen their pockets—a goal that most plaintiff’s attorneys pride themselves in. In Comparison, drug and medical device companies exist for the sole purpose of improving patient treatment and health, with the goal of advancing science and technological innovation.

A case like this should raise more questions about the doctor’s attorney’s use to testify as experts, and whether their attorneys are “ghostwriting” their reports and testimony in a favorable light to their case. One group of experts cannot be victimized—those that work with industry—while another group—those that work with litigators—go unchecked.

Wakefield’s research “suggested that measles was a cause of autism because he and his colleagues purportedly detected components of the measles virus in the gastrointestinal tracts and blood of children with autism that were not present in typically developing children.” In contrast to his research, “D'Souza and colleagues (2006) “found that although his technique produced many positive reactions in both children with ASDs and typical children, these reactions were further analyzed and found to be false positives for all subjects.”

According to the blog post, Wakefield was “found by Brian Deer to have been paid a great deal by this group seeking to pursue litigation against vaccine manufacturers in the United Kingdom.” This “conflict of interest” resulted “ten of Wakefield's co-authors requesting that their names be withdrawn from the original publication in the journal Lancet used as support for this hypothesis.”

The damage done by Wakefield is significant because it has destroyed the “public's confidence in vaccination,” and it has given people another reason to distrust the work of doctors on valuable clinical research. The fact that such fear can come from the financial incentives offered by attorneys is disturbing. While it is certainly true that everyone deserves their day in court, falsifying information to get on the stand will never bring about justice.

New York Times: Follow The Science Not the Money

 

Although recent media and government attention to conflicts of interest have centered on the medical world of physicians and the drug industry, a new development regarding COIs has come to the attention of one New York Times reporter in an article titled Corporate Backing for Research?  Get Over It.

The story of conflict focuses on Nobel Laureates Al Gore and Dr. Rajendra K. Pachauri, who won the prize in 2007 on efforts “to protect the planet from the ravages of greedy fossil fuel industries.” Their work however, came under scrutiny “journalists started looking at the money going to companies and nonprofit groups associated with Mr. Gore, and Dr. Pauchauri, the chairman of the United Nations Intergovernmental Panel on Climate Change (IPCC).

Dr. Pauchauri is now contending with accusations of conflict of interest due to his initial warnings of a “very high” likelihood that global warming would cause the Himalayan glaciers to disappear by 2035. In response to such an idea, “the Indian government subsequently published a paper concluding there was no solid evidence of Himalayan glaciers shrinking because of global warming.”

Putting these findings aside, Dr. Pachauri dismissed such research as “voodoo science” beneath the I.P.C.C.’s standards. His dismissal however, was deeply flawed because it relied on a claim by Syed Hasnain, a glaciologist who now works in an Indian research group led by Dr. Pachauri. Essentially, “the I.P.C.C.’s projection was based not on the latest peer-reviewed evidence, but on speculative comments.”

Not only did Dr. Pachauri apologize for this mistake, he also had to acknowledge his “worldwide portfolio of business interests, which included relationships with carbon-trading companies and his research group, the Energy and Resources Institute.”

In his own defense, Dr. Pachauri responded that “he had not profited personally and that he had directed all revenues to his nonprofit institute.” Such an assertion highlighted the common and unfortunate reality of conflict-of-interest accusations that too often “follow the money” even though it leads to nothing but “cheap ad hominem attacks.” As we usually comment about why media feel that doctors being paid for legal work with industry constitute a conflict, NYT posed the question: “why are journalists and ethics boards so quick to assume that money, particularly corporate money, is the first factor to look at when evaluating someone’s work?”

As the article accurately describes, journalists are “lazy,” and would rather try and tie money and corporate connections than “analyze all the other factors that can bias researchers’ work: their background and ideology, their yearnings for publicity and prestige and power, the politics of their profession, the agendas of the public agencies and foundations and grant committees that finance so much scientific work.” Such difficulty in the field of journalism is not monitored by any well followed or nationally recognized code or standards.

Application to Medicine

Some critics of work with industry such as The Journal of the American Medical Association made it a requirement that any published had at least one author with no ties to the industry who would formally vouch for the data. When the author in question works with a totally different company or on a different kind of drug or study, or multiple companies, why should this matter?

The weaknesses of this approach were quickly addressed in BMJ (formerly The British Medical Journal), “which analyzed dozens of large-scale clinical trials in previous decades and reported that industry-sponsored ones met significantly higher standards than the nonindustry ones.”

Another unintended, yet harmful consequence is that these so called ‘conflicts’ are scaring away “the best medical researchers and causing them to shun drug company money altogether — not because they think it leads to bad research, but because they are tired of that fact being highlighted every time they are identified in a news story, as if that were the most important thing to know about their work.”

In fact, NYT even asserted that “too often, corporate conflict-of-interest accusations have been used as smear tactics to silence scientists who ended up being correct. (Go to nytimes.com/tierneylab for examples.)”

Ultimately, as the author suggests, journalists should simply list a link to a page where scientists can list all their public and private donors, “and let readers decide which ones are potentially corrupting.” Moreover, conflicts that should be reported should be relevant, not a financial life story.   

We agree with Dr. Pachauri: “follow the science, not the money,” because that’s what will help physicians treat patients and make people healthier.

Hyperscrutiny of Academic-Industrial Relationships: Potential for Unintended Consequences

 

A paper in the Journal of the American College of Radiology titled “Hyperscrutiny of Academic-Industrial Relationships: Potential for Unintended Consequences—A Response,” examines the current environment of academic-industrial relationships.

Although the authors note that such relationships “are coming under intense scrutiny from government and other regulatory bodies … academic-industrial collaboration is an engine that drives innovation in the biomedical sciences in this country.” As a result, the article calls on members of the academic radiology community to ensure that the societal benefits of these relationships are not sacrificed via “overregulation.”

 

The reason industry support is needed for academic radiology is to ensure that society can educate the next generation of radiologists, and help clinicians maintain and enhance their expertise as science and the practice of medicine continuously advance, and being. Another reason why industry support of radiology is important is because it allows radiologists “to do the seminal research projects that drive innovation and improve human health through superior diagnostic and therapeutic technologies and techniques.” The private industry funding of such techniques and technologies are extremely important because “government priorities and budget shortfalls threaten sources of research funding for radiologists.”

 

To address the need for more radiologists in academia, “leading academic radiologists created the Association of University Radiologists (AUR), to “stimulate interest in academic radiology as a medical career; advancing radiology as a medical science; and representing academic radiology at a national level.” In collaboration with the AUR, the authors acknowledged “one very successful program that was created through an alliance with a major industrial partner that has a strong business interest in the continued vitality of academic radiology: GE Healthcare.”

 

Although the authors exaggerate some of the recent conflicts associated with academia and industry, their analysis of AUR’s GE-AUR Radiology Research Academic Fellowship (GERRAF) program, reveals just how crucial these relationships can be. Additionally, while it is important that industry and academia learn from the very few mistakes in the past by driving for greater transparency, this does not mean the overregulation of collaboration between academia and industry.

 

Rothman Recommendations

 

In analyzing the GERRAF program, the authors dispute three recommendations from the April 1, 2009, JAMA article by David J.Rothman, et al. Specifically, they assert that adopting such recommendations would be unnecessary, burdensome, and would eliminate many professional medical associations (PMAs).

 

In the case of the GERRAF program, fellows receive annual stipends of $70,000 per fellow, travel support for fellows and mentors, and honoraria for non-radiology board members from GE. If the program was to follow Rothmans first recommendation—completely banning pharmaceutical and medical device industry funding except for income from journal advertising and exhibit hall fees—GERRAF would see its 17 years of success meet a quick end.

 

Instead, the authors assert that transparency is a “far better” option than prohibition because like many fellowships, resources are limited and shrinking.

The authors also believe that implementing Rothman’s fourth recommendation-- preventing appointees from knowing which company’s funds underwrote their fellowship or travel—is “impractical and inappropriate.” In fact, they acknowledge that “the policies and procedures needed to protect this secret would contradict the drive for transparency and full disclosure.” Another undesirable result from this recommendation would be that “small societies with limited financial resources would not be able to fund fellowships and training programs.”

 

The article asserts that banning research “support for the current and future officers and board members of an organization such as the AUR would be unnecessary, counterproductive, and catastrophic to the future of the organization.”

 

Conclusion

 

The authors concluded that the GERRAF program “has generated impressive results and provides an informative example of a healthy industrial-academic partnership” because it fostered “a reciprocal relationship that benefits the radiology profession, the industry, and GE.”  The article found that “the training provided via the GERRAF program develops highly skilled health outcome researchers necessary to conduct the studies that demonstrate improved quality or health outcomes, reduced costs, and assessed treatment options using medical imaging.”

 

Considering the relatively “modest level of industry funding required to operate, the GERRAF program is an example of industry support for a specific PMA program that is core to the PMA’s mission.” As a result, the authors felt that “academic-industrial partnerships in research and education have provided the impetus for tremendous advances in medicine and have helped train generations of practitioners.”

 

Since these partnerships are “good public policy and should be preserved,” the authors recommended that the recent “hyperscrutiny” that attacks the physician-industry relationships should be abandoned. In fact, the article noted that “such a paradigm shift would end decades of productive partnership.”

 

These programs are important because participants are “influenced far more by their real-life experiences both before and after their involvement than by the knowledge that a particular company funded their program.” Academic-industry relationships “benefit academic radiology and other practice areas and are “rationally” regulated to avoid inappropriate industry involvement.” These partnerships “should be celebrated, and encouragement for the development of similar programs should be freely given.”

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.

 

Pfizer ‘s $3 Million CME Grant to Stanford University

According to a recent article in the New York Times, Stanford today will “announce plans to develop new continuing education programs for doctors that will be devoid of drug industry influence.”

 

As is the case for most media accounts of continuing medical education (CME), the article makes an exaggerated claim that industry influence has “often permeated” developing CME courses. The author however cites no evidence to this assertion, and does not suggest any alternative sources for funding these state mandated and heavily accredited courses.     

The article reported that a $3 million grant was given to Stanford University by drug maker Pfizer. In response to this grant, Dr. Philip Pizzo, dean of the Stanford medical school, noted that “Pfizer will have no say on how the three-year grant will be spent.”

Consequently, NYT noted that Stanford plans to use the money “to set up unbiased programs of postgraduate education.” The article tried to assert that these new programs will be different than “the industry-selected topics of the past” by trying to paint them as biased because they were presented “to rooms full of doctors at hotels and resorts.”   

That is of course unless you are Stanford University who according to their CME website are conducting CME programs in such hardship posts as The Grand Hyatt Resort and Spa Poipu Beach Kauai, Hawaii and The Big Sky Resort, Big Sky Montana.  Aren’t these resorts, perhaps the rooms aren’t full?

Such a claim by Stanford is problematic because ACCME Standards for Commercial Support clearly outline already that any funding from a company or industry to an accredited CME program cannot have any say whatsoever in the content being presented. Moreover, the fact that programs are being held in hotels only reflects the need for a large area to manage hundreds of physicians and presentations, as well as a geographically accessible area for doctors in rural and low population areas to be able to attend.

The article quotes Dr. Pizzo “criticizing the drug industry for poisoning educational programs with marketing messages and doctors for “complicity” in taking speaker fees and expenses-paid trips.” As we have noted numerous times, CME programs are prohibited from marketing any particular drug or device at accredited programs, and only discuss the clinical and research data associated with a particular treatment. Additionally, the fact that physicians take speakers fees and expenses-paid trips are no different than physicians being paid to testify at court.

David J. Rothman, a professor and president of the Center on Medicine as a Profession at Columbia, was quoted in the article as “surprised” that Pfizer would “give money with no strings attached” and stated that “I don’t know many more times they will give money with no strings attached.   A $3 million grant from Pfizer with no strings attached should come as no surprise considering all grants tied to CME from industry are prohibited from marketing or control of content under ACCME standards. In addition, many drug and CME companies have already installed new guidelines with similar standards.

Accordingly, “Pfizer in a statement, said it wanted to help redefine how continuing medical education was financed to ensure the independence and patient benefit of the programs, which most doctors are required to take to maintain their state medical licenses.”

Even with a strong statement such as this, NYT still claims some still see “inherent conflicts in the Pfizer connection.” It is hard t see how anyone could see a conflict is problematic, especially when Stanford has declared it will use the grant “to focus on areas that need improvement, such as diabetes, cardiovascular disease, smoking cessation and infections.” The university also “plans to use advanced technologies, including a simulated hospital, rather than lecturing.”

Critics claim that because “Pfizer has major products in two of the four areas that the Stanford press release suggested might be pursued: smoking cessation and heart disease,” that the grant is ‘conflicted.’ They also point to a $2.3 billion settlement last year for government fraud charges of deceptive marketing for promoting off-label uses for the pain drug Bextra. While such a case should not be ignored, the issues did not directly involve CME.

While other opponents of industry funded CME believe that industry influences topic selection, tone of presentations and advice given to doctors, the fact still remains that drug and medical device companies have paid more than half the total cost of the programs.   Also there is no evidence that industry which no longer sets the tone is somehow biased.

Without such funding, where will doctors be able to take CME courses to keep their license and accreditations? More importantly, where will doctors learn about the new drugs, treatments, and devices if the industries and company’s making these life saving technologies cannot teach them to anyone?

Dr. Arnold S. Relman, a former editor of The New England Journal of Medicine, a Harvard professor emeritus, goes as far as stating that for medicine “to be independent and trusted,” taking money a drug company under any conditions should be avoided.

In 2008, Pfizer “became the first drug company to say it would no longer provide such money directly to profit-making medical education companies, but only to universities and other nonprofits.” Similarly, in September 2008, “the Stanford medical school became the first in the nation to stop accepting industry financing for specific topics in postgraduate educational programs. It will accept only industry money that was pooled in a general fund for the education programs.”  This does show that this announcement by Stanford may not be quite as rigid as Stanford had originally made it out to be.

Ultimately, Stanford noted in a press release: “The Pfizer grant comes with no conditions, and the company will not be involved in developing the curriculum.” Critics who construe such a statement to show the potential for conflict are misguided.

The article includes quotes from four industry critics and no proponents.  The critics are playing their hand showing that in reality they oppose industry supported CME under any circumstances.

Stanford and Pfizer should be applauded for this collaboration and finding a middle ground.  Despite Stanford’s anti industry rhetoric, their example should be a testament to the media and public about the confidence industry has in fueling research in academic medical centers for the purposes of better patient care.

 

 

Study Shows Overwhelming Majority of Journals Track Relationships with Authors

A recent article in the Journal of the American Medical Association (JAMA), titled “Requirements and Definitions in Conflict of Interest Policies of Medical Journals,” examined the COI policies of medical journals to determine the prevalence and variability of COI disclosure requirements and definitions.

 

The article noted that “recent studies examining the content of COI policies among journals with a clinical focus are limited,” and there is “variation between journals in handling information about COI.”

 

According to the report; an overwhelming majority (89%) of medical journals have readily available on-line COI policies and require submission of COI statements.  Those remaining 11% without online COI statements in all likelihood have COI policies, just not readily available for review.    

 

This represents a major change in collecting and disclosing COI by medical journals.  A 1997 study found only 16% of medical journals had COI policies in place as compared to 89%+ today.

 

All high impact journals have COI policies and procedures in place.

 

Research Findings

 

The study identified 2117 medical journals across 35 subject categories, with 262 journals from these 35 subject categories being used.

 

Of 262 journals, 256 (98%) provided a URL linking to Instructions for Authors, manuscript submission forms, or both.

 

Within the Instructions for Authors, 25% of journals included online links to policy statements or articles on COI.

 

The study found that 228 of 256 sampled journals (89%) had language requesting author COI disclosure, and 89% of medical journals also had COI policies available for public review. Of the 89%, eighty five percent of journals requested COI disclosure in the Instructions for Authors, and an additional 4% requested COI disclosure only in manuscript submission documents. Of 256 journals, 138 (54%) required authors to submit signed disclosure statements.

 

77% of the journals defined or gave examples of possible COIs for submitting authors, and most of these journals included direct financial relationships such as “equities interest or stock ownership” (89%) or “consultancies” (84%). A minority included other potential conflicts such as personal relationships (42%), paid expert testimony (42%), relationships with organizations (26%), or travel grants (12%).

 

All internal medicine, respiratory medicine, and toxicology journals studied had comprehensive COI definitions, with 19 of these 24 journals requiring signed disclosure attestations.

 

6 of the 19 highest-impact journals in geriatrics and gerontology; radiology, nuclear medicine, and medical imaging; and rehabilitation requested that submitting authors disclose COIs.

 

Another survey (published in 2006) of the editors of 91medical journals found that 93% of medical journal editors reported having a COI policy.

 

Conclusion

 

In 2008, most medical journals with relatively high impact factors had author COI policies available for public review, although there was substantial variation in journal policies for solicitation of author COIs and in definitions of COI. 

 

The study was limited because the authors did not survey the journal editors, and relied on review of journal policies available on the Internet. As a result, the authors noted that their “methodology could lead to underestimation of the prevalence of COI policies if COIs were only requested by editors in communication with authors after submission.”

 

Additionally, the research found a lack of uniformity among journal editors on what constitutes COI, highlighting the difficulty authors encounter as they submit to different journals may limit the intended goal of COI policies. As a result, the article mentions the recent work of the ICMJE and editors of leading medical journals who have implemented increasingly comprehensive policies regarding disclosure of authors’ financial interests and other potential conflicts. Consequently, they even asserted that “conflict of interest policies and their implementation have evolved over time,” which led the study to conclude that journals have experienced “a substantial increase in the prevalence of COI policies over the past decade,” an “encouraging finding.”

 

Another factor that has led to this increase in COI policies in journals is that ICMJE member journals have recently published a uniform vehicle for recording and submitting COI disclosures. Although this new uniform disclosure form has standard definitions and disclosure requirements and enables authors to save online copies of the forms that can be updated as needed, ICMJE member journals are still testing this form and the universal disclosure process and are asking for feedback until April 2010.

 

Once journals and ICMJE members are able to gather enough information about the effectiveness and drawbacks of this form, journals will hopefully be able to eliminate the need to reformat disclosure information for each submission to ICMJE member journals and other journals that would eventually accept this universal disclosure form.

 

Ultimately, this JAMA study is an encouraging piece or research revealing the recent trends in journals, editors and articles habits of disclosing information and reporting potential COIs. The future transparency among companies, researchers and physicians in the coming months will only continue this trend to help certain media sources and officials realize that authors and editors of journals maintain high levels of integrity when disseminating research breakthroughs to the public.

Interventional Cardiologist Speaks out on Work with Industry

A recent article in the Journal of Health Care Contracting tried identifying problems with conflict of interest regarding speaking and consulting for industry, by focusing on two specific questions: first “how susceptible are physicians to being influenced to purchase products or equipment, or prescribe certain drugs, based on their relationship with a vendor and the freebies or consulting/speakers’ fees they receive? And second, do physicians, in fact, make purchasing or prescribing decisions based on relationships rather than on the merit of the product or drug?”

In response to the first question, the article provided that physicians are not influenced because most drug and device makers such as the Advanced Medical Technology Association (AdvaMed) and Pharmaceutical Research and Manufacturers of America (PhRMA), already have “spelled out model codes of conduct for their members, proscribing certain practices, placing limits on gifts, etc.” Additionally, “many professional societies and associations, including the American Medical Association, also have codes of conduct or ethics in place,” which make it highly unlikely that any relationships influence purchasing or prescribing decisions.  

This kind of evidence was also emphasized by the Association of Clinical Researchers and Educators, or ACRE, who held its charter meeting in Boston last July. The article cites that “ACRE (www.acreonline.org) is an organization of medical professionals who recognize that appropriate physician-industry collaborations and relationships benefit patients and advance science."

Accordingly, the article noted comments from ACRE steering committee member Carey Kimmelstiel, M.D., director of cardiac catheterization laboratory and interventional cardiology, and director of clinical cardiology at Tufts Medical Center in Boston. He is also an associate professor of medicine at the Tufts University School of Medicine.

As Dr. Kimmelstiel asserted, today’s efforts to eliminate conflicts of interest have gone too far because the practices about which people are concerned - such as gift-giving, nice trips, etc. - have pretty much been eliminated. He also noted that rules reimbursing physician practices for talks are tight as well, probably too tight.

For example, when Dr. Kimmelstiel tried giving a presentation on a drug recently, he wanted to add some slides to his presentation to share his clinical experience with others but, he was unable to since the presentation had already been reviewed by the FDA and no changes could be made.

Essentially, the point Dr. Kimmelstiel was trying to make is that “most physicians are savvy enough to be able to ferret out those who are giving a talk of value vs. those who are prostituting themselves.” Moreover, the idea that a physician is going to change their practice patterns or be influenced by what they prescribe by Post-It notes or pens they use is problematic.

As a result, Dr. Kimmelstiel acknowledged that these “overly strict conflict-of-interest policies can stand in the way of the education of students, physician trainees and practicing physicians.” He noted that “groups of fellows and physicians gather on a regular basis to listen to cases and share knowledge on particular medical topics at local restaurants which are often subsidized by industry.” Since new guidelines will prevent this, he wondered "Who will fund them, since hospitals and state government will not.”

Dr. Kimmelstiel also indicated that stricter conflict of interest policies could “potentially spell an end to clinical research being carried out at hospitals.” He even cited how some companies are leaving states like Massachusetts for other states, where they do not have to spend time worrying about compliance and exposure.

In the end, Dr. Kimmelstiel asserted that since “physicians need ongoing education on new technologies and pharmaceuticals, the best people to provide that training are other physicians.” Consequently, physicians who provide such training are not ‘promotional speakers’ because the only thing they are promoting are their patient’s health. What Dr. Kimmelstiel calls it is ‘industry-funded speaking.’ The only way to give physicians the training about new technologies, clinical guidelines and clinical trials is to conduct educational sessions, which physicians should be paid for. Why would a physician take the time to do it for free? Why would any profession?

What Kimmelstiel and ACRE want regarding conflict of interest policies are "to begin to level the playing field, to begin to have a discussion so we don’t stop doing clinical research, so we don’t stop educating our peers and others." In order to carry out this discussion, "there are no way physicians and CME can survive without industry."