Policy and Medicine

ACRE Responds to the ProPublica Second Report Industry Payments to Physicians

 
ProPublica this evening released their compilation of payments to physicians "Dollars for Doc's and rather than report on what was spent in 2010, they once again showed their lack of fair balance and reported the aggregate of funds paid to physicians since the beginning of public disclosure which amounted to $760 million dollars over several years.   In response to this “Campaign of Shame” the Association of Clinical Researchers and Educators (ACRE)  announced its opposition to the improper use of physician-industry payment data by ProPublica.  

ACRE strongly recommends that ProPublica strictly abide by the Society of Professional Journalists Code of Ethics, which encourages all journalists to “promote public enlightenment” by, “seeking truth and providing a fair and comprehensive account of events and issues.”  ProPublica should develop, and publicly report on, safeguards and compliance mechanisms to ensure that it is providing objective, fair balanced reporting of all issues, including physician-industry collaborations which have wide ranging implications for patients everywhere.

Almost one year ago, ProPublica published its Dollars for Docs database, which combined compensation data for research, consulting and education, as well as transfers of value such as accompanying meals during such activities, from several biopharmaceutical companies and created a searchable website for journalists and, ostensibly, for the public to see how much a particular doctor earned for various activities. 

After publishing the data, ProPublica and other media outlets, to whom data and stories were provided, failed to objectively portray such payments and offered minimal, if any, contextual information.  Numerous articles were published describing the “potential” negative consequences of physician-industry collaboration, while failing to obtain any alternative perspectives, a tenet of high quality journalism.  News sources also frequently published articles with inflammatory headlines such as, “Docs paid to talk about drugs,” to further sensationalize and discredit ethical and legal collaborations that provide value to patients in the form of new treatments, drugs, devices, and more efficient and cost-effective care.

ACRE is concerned that ProPublica will continue to provide coverage of these issues that do not meet the basic principles of journalism.  In particular, we are concerned that ProPublica will continue its ad hominem attack on physicians who educate their peers, conduct clinical research, and consult with industry to ensure that Americans have the most advanced treatments and medicines, providing little opportunity for public enlightenment. 

What value does ProPublica bring to the American healthcare system by “analyzing” and publicizing such payments?  Will it lead to lower costs when drugs account for less than 15% of health care costs?  Will it lead to better patient outcomes?  Will drugs, devices or treatments get to patients sooner and through FDA approval faster?  Will clinical trials be conducted more safely and efficiently because payment data is now available? 

ACRE members from leading academic health centers across the country can attest that the answer is, no.  In fact, poor reporting of payments is having the opposite effect.  Reporting on payment data without proper contextual information is having a chilling effect on important collaborations, which hurts progress and patients.  Fewer researchers are doing research, educating their peers, and consulting with companies.  These added costs of one-sided transparency campaigns do not outweigh the benefits.

ACRE will continue to shine the light on ProPublica until they meet their journalistic duties and provide balanced coverage of this important health care issue.  We will also defend the physicians and health care providers who collaborate and work with the biopharmaceutical industry.  They are responsible for the advances in medicine that we rely on now and hope for in the future.

ACRE Releases Statement on Enhancing FDA Advisory Committee Recruitment

 
The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug Administration’s (FDA) conflict of interest standards.  ACRE strongly recommends that FDA adopt new policies that ensure experts with the highest scientific and clinical qualifications are actively recruited to serve as advisory committee members.

The FDA regulates more than 150,000 marketed drugs and medical devices, with nearly 3,000 investigational new drugs being developed at any given time.  These advances offer hope for patients and the opportunity to improve public health, which must be balanced against the potential risks.

Although FDA employees have extensive scientific and medical training and experience, they cannot alone encompass the full range of expertise necessary to evaluate the increasingly complex minutiae associated with medical innovation.  The agency therefore looks to outside experts to serve on technical and scientific advisory committees that evaluate the safety and efficacy of experimental products. Advisory committees provide crucial independent advice to assist with regulatory decision-making processes and support sound decision-making by the FDA.

In 2007, new conflict of interest standards were adopted that set an arbitrary financial threshold for committee participation.  Experts with personal or family financial interests above $50,000 are excluded from serving as committee members, and even if conflicts are resolved, they must wait at least one year before being permitted to serve.  Those with interests below the threshold are allowed to serve, but are stripped of their voting rights.

Since adoption of these new policies, committee vacancy rates have steadily increased.  The most recently released data for overall FDA committee membership from the third quarter of 2010 show vacancy rates ranging from 25% to 27%.  The Center for Biologics Evaluation and Research (CBER) vacancy rates are markedly worse, reaching 32% for the last three months of 2010.

“These rising vacancies clearly demonstrate the unintended consequences of overly restrictive conflict of interest policies,” stated Michael Weber, MD, a Director of ACRE, “Both government and industry rightfully seek out accomplished leaders in many fields for their expertise.  Excluding a portion of these leaders because they have collaborated with industry to promote advancements in science and health is hindering the FDA’s ability to meet its responsibilities to patients.  Product reviews are unnecessarily delayed along with patients’ access to new therapies and medical devices.”

Data obtained by both critics and supporters of industry collaboration consistently reveal that industry consultants are often the most qualified and prominent physicians and productive researchers.  Moreover, detailed analysis of FDA panels’ recommendations reveals no effect of industry relationships on panel members’ voting behavior.

“Advisory committee members should be chosen based on their direct experience with, and expert knowledge of, the specific technology under review,” stated Weber.  “ACRE supports a transparent evaluation process under which remuneration from for-profit and non-profit entities is examined and made available to the public. Relationships that indicate direct financial interests with an entity whose product is the subject matter of a particular Advisory Board meeting would reasonably lead to recusal of a potential advisor..  Other interests, including so-called perceived conflicts, should not be used as exclusion criteria.”

“We urge the FDA to further scrutinize the impact its current conflict of interest policy is having on product reviews and approvals and make the appropriate adjustments.”

About ACRE

The Association of Clinical Researchers and Educators (ACRE) is a non-profit professional organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts. ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration. In addition, ACRE will identify and train next generation of researchers and educators.

Association of Clinical Researchers and Educators: Claiming Lost Ground -- Advancing Patient Care

 
Late last week, the Association of Clinical Researchers and Educators (ACRE) held a conference to discuss the importance of physician-industry collaboration.

ACRE is an organization of physicians and colleagues engaged in promoting excellence in medical service, education, and innovation. ACRE members have records of achievement in these endeavors.

The second ACRE meeting took place at the Weill Cornell Medical Center in New York City, New York.  This year’s ACRE 2011 meeting covered a number of areas and topics and included speakers and representatives from across the health care industry.  Slides and presentation materials are posted on the meeting site. Topics included:

• The History of the Conflict of Interest “Mania”
• Issues in the field of continuing medical education (CME)
• Why Academia/Industry Collaboration is under attack
• Academic Medical Centers
• The Importance of Academic-Industry Collaboration for Patients; and
• Washington and Innovation

The meeting was covered by the New York Times, which noted how the conference started by addressing the term “conflicts of interest.” Several presenters noted that, “conflict of interest” is a “pejorative term” and that a better term is “overlap of interests,” because the drug and device companies want to market products to help people, and the researchers and professors want to help them find new cures and spread the word.

Another panel during the meeting looked at why academic-industry collaboration is under attack by not only “politicians, deans and the media” but also medical journal editors, the Association of American Medical Colleges, the Institute of Medicine of the National Academy of Sciences, the National Institutes of Health, the American Medical Association, the United States Department of Justice, and of course the media.

Dr. Thomas P. Stossel, a Harvard medical professor and co-founder of the group, said that drug companies, years ago, reported their financial support for professors and researchers to honor them.

“Now, it’s a confession of guilt,” he said of the lengthy financial disclosures that many speakers flashed on the screen. Most of them said the industry support proved their value.

He noted that several academic organizations that received media in their announcements of strict policies have since backed off these policies due to push back from faculty, the implacability of the proponents of the rules and difficulty of implementation of these strict policies.

Dr. J. Michael Gonzalez-Campoy, chief executive of a Minnesota obesity center and past president of that state’s medical association, said the growing pressure to disclose financial ties with drug and device makers is leading further, too far, to outright bans of such ties in the leadership of some medical societies.

The collaborative research and marketing, he said, help to bring drugs to patients that prolong and save lives.

Dr. Michael A. Weber, another cofounder of the group and professor of medicine at the SUNY Downstate Medical Center in Brooklyn, said ACRE plans to push back by drafting its own guidelines for what is proper in industry-academic collaborations.

A panel of grateful patients was led by Montel Williams, a former talk show host who is battling multiple sclerosis, raising funds for medical causes, and recently received experimental treatment with what he described as great success.   It was encouraging that Montel pushed the audience to be proud of the work they do with the medical products industry and not cower back because of criticisms.

Mr. Williams urged the beleaguered professors and researchers to stand up to critics and make it clear they are life-savers.

“Do your job!” he said to applause.

ACRE

The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry.

Another of ACRE’s main tasks is to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. ACRE also represents a voice that is heard and quoted when these industry-academia relationships are attacked, as they have been in the past.

Additionally, ACRE provides education for health care professionals and patient advocates to empower them to fight those policies that undermine productive collaboration.” The organization is also charged with training our current and next generation physicians so they can promote true excellence in medical education and innovation.

It is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research.

The slides for many of the presentations are available on the ACRE website:

ACRE 2011 Slides (Underline and Green)

In the near future the full program will be available in streaming video and MP3 audio files.

Association of Clinical Researchers and Educators 2011 Meeting – July 22 in NYC

 
The Association of Clinical Researchers and Educators (ACRE) is an organization of physicians and colleagues engaged in promoting excellence in medical service, education, and innovation. ACRE members have records of achievement in these endeavors.

Consequently, ACRE recently announced that it will be holding its annual meeting.  The meeting will take place on July 22, 2011 at the Cornell Medical Center in New York.  For more information about the meeting and registration, click here.  ACRE previously held its charter meeting in 2009.

This year’s ACRE meeting will cover a number of areas and topics and will include speakers and representatives from across the health care industry.  Topics include:

-          Issues in the field of continuing medical education (CME)

-          Why Academia/Industry Collaboration is under attack

-          Academic Medical Centers; and

-          Washington and Innovation

The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry.

Another of ACRE’s main tasks is to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. ACRE also represents a voice that is heard and quoted when these industry-academia relationships are attacked, as they have been in the past.

Additionally, ACRE provides education for health care professionals and patient advocates to empower them to fight those policies that undermine productive collaboration.” The organization is also charged with training our current and next generation physicians so they can promote true excellence in medical education and innovation.

It is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research.

ACRE Response to NIH Proposed COI and Transparency Policy

In response to the National Institutes of Health (NIH) call for comments regarding proposed transparency rules, the Association of Clinical Researchers and Educators (ACRE) recommended that the agency “not adopt the proposed rules and recommendations until further discussion occurs.”

By offering to “be an active participant in this discussion,” ACRE noted that its members, Educators, Medial Society Leaders and distinguished Professors at academic centers, are ready to engage NIH in a more “careful and thoughtful deliberation” regarding healthy interactions between academia, the government and the private sector.

ACRE also noted that because it’s members are engaged in promoting excellence in medical service, education, and innovation, and have substantive track records in these endeavors, the group hoped to show NIH that the public “has much more to win by a vibrant and high level of engagement between the private sector and medicine.”

In addition, since the new NIH rules  propose further “restrictions on these interactions” without offering evidence to support its claims, ACRE recognized that the agency will “create an unnecessary burden on individuals and the government (wasting precious resources).” From these findings, and as described by some of the points below, ACRE urged NIH “to consider a delay in implementation until such issues have been carefully considered.”

Accordingly, ACRE pointed out that the framing bias used by NIH to propose the amended rules “represents a one-sided, prejudice view on a complex topic that disarms the arguments of the accused.” The problem with this approach is that a “massive financial conflict of interest (FCOI) ideology has flourished and created a compliance industry that has inherent COI on its perpetuation,” despite “overwhelming evidence that collaboration with industry has yielded immense value and little harm.”

Another significant problem ACRE points out with the proposed NIH rules is the tremendous administrative burden carrying out these regulations will have. The number of hours and cost alone will apply serious pressure and stress to already understaffed and underfunded agencies, not to mention institutions. This will have an adverse affect on physician’s willingness to participate in NIH funded research, which will ultimately harm patients by creating less opportunities and breakthroughs.

The impact of the rules will also be felt by non-profits and CME providers, due to new requirements to disclose payments for each of these stakeholders. Such reporting will create “a false innuendo that CME is something that creates a FCOI.”

ACRE also acknowledges the weakness in NIH’s proposed rules because the agency relies on the Wazana paper, and they do not cite any research that shows the many benefits of commercial contributions to medicine. Consequently, ACRE correctly points out the fallacy in using the Wazana study because it “explicitly stated that of the publications reviewed “…no studies used patient outcome measures.”

It was also noted in their response that the proposed NIH rule is no longer necessary since the implementation of the Physician Payment Sunshine Act is already underway.

What ACRE also found problematic about the proposed rules is that they would hurt the willingness of physicians to participate in NIH funded research, because the rules “risk strengthening the misperception that all significant financial interests (SFI) constitute FCOI.” 

Conclusion

Since public trust in doctors is high and stable, according to a series of Harris polls on "most trusted professions," ACRE asserted that “physician-industry collaboration should be regarded as a “win-win” relationship because it adds value and aligns the interests of medicine.”

Ultimately, because Americans want better ways to fight disease and improve health, ACRE noted that NIH is misguided to assert that Americans do not want “FCOI”s to influence the federally funded research. Accordingly, because innovation, in large part, results from industry translation of NIH-funded research and has delivered these desired outcomes, ACRE hopes to be actively involved in discussion with NIH to help encourage such partnerships and maintain their integrity.

 

 

AMA CEJA 2010: ACRE Recommends Rejecting CEJA Report Financial Relationships with Industry in Continuing Medical Education

In response to the American Medical Association Council on Judicial and Ethical Affairs (CEJA) fourth attempt to hinder physician and institution relationships with industry, the Association of Clinical Researchers and Educators (ACRE) recommended that CEJA Report 1-A-10 and its recommendations be rejected by the AMA House of Delegates.

CEJA’s report, entitled “Financial Relationships with Industry in Continuing Medical Education,” without any significant evidence to support their proposal, improperly asks individual physicians and institutions of medicine to not accept industry funding to support professional educational activities.  As a result, ACRE called for the rejection of 1-A-10 for many reasons including:

· CME is already highly regulated to prevent undue influence from industry

· Reducing resources in CME will result in less education of physicians

· With the adoption of Health Care Reform and the subsequent addition of 30 million new patients to the healthcare system, additional financial resources will be needed to educate a greater number of physicians and other healthcare providers not less

· The CEJA report ignores 3 recently published studies, involving very large study populations, which are directly relevant to the Report's subject matter but "contra" to the report's recommendations. By an overwhelming margin, doctors who actually attend commercially sponsored CME do not perceive bias.

· Passage of the Physician Payment Sunshine Provisions in Health Care Reform eliminates the need for more detailed disclosure as recommended in the CEJA report

In ignoring ACRE’s previous response to their third report and ignoring recent evidence that industry support does not produce bias in CME, CEJA’s report is tendentious and contrary to "evidence-based professional ethics because 1-A-10 is virtually the exact same report that has been rejected three times previously by the House of Delegates.

Accordingly, CEJA must realize that CME is already highly regulated by ACCME Standards for Commercial Support and the FDA Guidance already enforce much of what CEJA considers changes and need for a code of conduct. Clearly then, there is no compelling reason or evidence to support their proposed changes.

By neglecting to use any real evidence to support their claims or underscoring health care reform legislation, CEJA’s Report 1-A-10 will only create auditing programs and ask for a magnitude of disclosure that would result in enormous undue administrative burdens on specialty societies and state accredited organizations running thousands of CME programs each year.  This ignorance is particularly problematic because their reliance on the same fifty seven (57) references that were previously rejected still leads them to admit that “to date, there is no empirical evidence to support or refute the hypothesis that CME activities are biased.”

CEJA acknowledges that presently, it “has not been clearly demonstrated to what extent the amount of a financial interest may influence perception and judgment” Instead, CEJA declares that “clear evidence is lacking” and acknowledges that most policies on “conflict of interest” at least tacitly assume that the greater the financial interest, the more problematic that interest is, but without any evidence. What evidence does exist about commercial support of CME?

This past year, three studies produced substantial data that demonstrate a lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF). So what did CEJA do with this data?  Nothing.

In choosing to pick which data CEJA wants to use to support their position and in disregarding this evidence, 1-A-10 is a complete contradiction.  Specifically, while recommending that physicians avoid industry funded CME, CEJA also recognizes that industry support is “vital to the professional community,” a clear example of how 1-A-10 uses faulty reasoning and contradictions. 

CEJA’s mistake is clear by a simple fact that they admit themselves: “in many situations, the only individuals truly qualified to train physicians in the earliest stage of adoption of a new medical device, technique, or technology, are often those who developed the innovation.” If industry support of CME should be avoided, who can teach doctors about new stents or pacemakers, when the person qualified created them?

Their ignorance is even more evident by CEJA’s recognition that there are also numerous circumstances when “access to appropriate, high-quality, independent CME may be seriously impaired if support from industry is refused,” such as when expensive equipment is needed, and accepting funds or in-kind support from multiple, competing firms might result in more independence than refusing such support.

These contradictions clearly confuse and ignore the proposal’s own acknowledgement that “industry support for CME helps to meet the costs of programs and activities in the face of uncertain funding from other sources.” It also reduces “costs to individual attendees and makes CME more accessible, especially for physicians in resource poor communities.” Consequently, since CEJA did not address these clearly conflicting statements, the least they could do is explain how physicians can get CME credits, education and training if in some cases, as CEJA also acknowledges, “CME may not be feasible without industry support.”  They do not however, explain where 50% of the funding for CME will come from and where doctors will get their education if industry funded CME is phased out.

Ultimately, ACRE’s response reflected the organizations belief that there is value to physicians, medicine, medical education, and patients from the working relationship between physicians and industry. There is no conflict in advancing science, and there is no conflict in providing the education that is required to do so.

By working together with industry colleagues, physicians can explain to the public that the contributions of corporations to medicine are, on balance, more beneficial than harmful and that both medicine and the industries that provide it with its technologies are worthy of public support. Cooperation, instead of antagonism, can help industry develop and market therapies with the highest integrity, by keeping physicians current on the best available evidence and by providing excellent patient care.

ACRE’s Response to CEJA 1-A-10

Other articles on CEJA 1-A-10

AMA CEJA 2010: Financial Relationships with Industry in Continuing Medical Education Version 4.0 – Same Report - Same References

AMA CEJA: Strike 4 - Report Perhaps Ushered from the CME Ballpark

Boston Review: Stossel Standing Up to the Unhealthy Opposition

 

Recently the Boston Review ran a series of six articles basically discounting almost everyone working in the field of medicine titled “Big Pharma Bad Medicine”.   But they also included a different additional article by Thomas Stossel, MD titled: Unhealthy Opposition.

 

When you look to rigorous scholarly analysis dependent upon empirical facts and logic rooted in practical experience and the canons of history, economics, and the epistemology of science, the value of academic-industry relationships is evident.  For decades since medicine and science merged in the twentieth century, breakthroughs in drugs, devices and medical treatment have grown rapidly, largely because of the funding industry has provided.  In fact, “industry investment in research tracks perfectly with extended longevity, reducing pain, and improving quality of life from a health standpoint.”

 

Since industry began taking greater responsibility for medical advances in the last 40 years, mortality from cardiovascular disease has fallen steadily by about half. Cancer mortality has remained flat in absolute terms and, relative to population, is at an all-time low.  Perhaps what is most important about these advances is that although many factors can contribute to this incremental reduction in mortality, products produced by industry are the most important according to economists such as Harvard’s David Cutler and Columbia’s Frank Lichtenberg.

 

Ignoring these advances, critics such as Drs. Angell and Fugh-Berman consider industry funding to be tainted, “it is not the first source of investment to be so designated,” according to Thomas Stossel, M.D., an oncologist at Brigham and Women’s Hospital in Boston.  He further pointed out the fact that “all sources are tainted” because there is never enough money to support the possible missions of universities.  So when money is given for health care innovation and education, people see it as a “sin,” but the reality is “medical research cannot do without industry support—at least, not as well as it has since that relationship began.”

 

In contrast, public funding of health care innovation is constrained by “political vagaries” that limit the ability of the National Institutes of Health (NIH) to promote health.  According to Dr. Stossel, “the only realistic supply of added funding is from industry, which currently provides less than 6 percent of university research funding.”  This support is highly needed because “without industry, there is no one to fill the gap.”  For example, last year, when industry payments for Continuing Medical Education (CME) fell by over $175 million, the total available funding for that activity fell by 7 percent.

Clearly then, industry’s role in medicine creates tremendous value, and as analyses by the Congressional Research Office and the NIH itself show, return on public investment has been amplified many-fold by industry contributions.  As a result, Dr. Stossel asserts that “collaboration between physicians, academics, and industry shows its benefits in these appreciated returns.”

What is important to consider about this collaboration is that developing innovation in medicine is extremely difficult because of heavily regulated FDA oversight, litigation threats from the Office of the Inspector General, and the laws of product liability.  Despite these obstacles and inherent risks, “the list of substantive incidents of fraud is strikingly short, especially in the context of the benefits of industry involvement, and the legitimacy of many of the accusations is questionable.

Critics of industry support must also realize that of all the great prospects in medicine, only one in roughly 5,000 becomes a drug, and that’s after sixteen years of research, on average, and billions of dollars spent.  As Dr. Stossel notes, “these dreary statistics do not arise from a lack of good intentions, or from greed. They are a consequence of nature’s inscrutability, overcome only by immense trial and error. Industry profitability enables that effort through investment, and lacking profit seriously slows innovation by limiting investment.” 

Those who straddle academe and industry deserve profit because “these researchers retained the credibility that unlocked investment from venture capital, and their networks facilitated talent recruitment and other technical contributions to product development.”  This kind of straddling is crucial today as “many potentially lifesaving technologies are languishing in the pipeline, especially now, with the investment ecosystem dried up by recession and paralyzed bank lending.”

But instead of making medical innovation and education easier, critics want to make it harder by creating further obstacles to the relationship between industry and academia.  In existence already are “academic and state regulations that invade privacy and mandate mass confession (disclosure), restrict freedom of speech (researchers who work with companies cannot discuss company products in high-profile medical journals), limit freedom of association (physicians can meet with company marketers only in prescribed settings), and undermine rewards for excellence (payments for value-enhancing services are capped or eliminated).”

One of the major sources of unnecessary allegations of corruption “is the widespread assumption that payments to physicians are likely to result in decisions favoring the payer and that this yields bad outcomes for patients.”  Those that cite the Wazana study, which claimed to find that industry gift-giving on a majority of interactions had negative results on clinical care, are misleading because the study has no information about “clinical care,” and explicitly says so.

Accordingly, any negative consequences “allegedly rising from financial relationships of physicians and academics with industry are almost entirely theoretical.” In fact, there is little perceived bias in commercially supported CME, as indicated by four publications in the past year, including a Cleveland Clinic survey of almost 100,000 CME participants.

Moreover, although the media only cover the value to “physicians’ paycheck for other industry funded activities, that value is transmitted well beyond the speakers and the audiences who hear them, and has a clear value for improving patient care.”  If critics would “set aside ideological concerns over supposed conflicts of interest” they could “focus on whether industry-supported research is producing better health outcomes for patients.”  What they would surely find is that “industry involvement in medicine continues to evolve, which is a good thing, because it creates efficiency.” 

Conclusion

It is easy for critics to base their “policies on ethics as an excuse to avoid the hard scholarly work of assessing risks and benefits in the highly complex and granular activities operating in health care.”  But their “failure to address this evolving complexity makes industry support for medical science an easy target for demonization, which has contaminated policy efforts.”

This has led policymakers to move from punishing those who break the rules of academic-industry collaboration, to banning the relationships all together.  Policies have also prohibited entrepreneurial faculty to raise industry funds for their specific research and education activities, which limits innovation and hurts patients.  This kind of framing bias regarding “conflict of interest” is contrary to the foundations of our country.  Specifically, “in Federalist 10 James Madison described the removal of conflicts (or factions, as he called them) as a violation of liberty, “a remedy . . . worse than the disease.”

Ultimately, critics who want to restrict industry relationships with academia and physicians will only create policies that divert time and money from innovation and education to legal and compliance-assurance efforts that grapple with confusing and, for the most part, unenforceable regulations. This shift will create impediments to physician’s education and learning of valuable information for patient care, the absence of which will cause patients to suffer.

 

Endocrine Today: Benefits of Collaboration to Create Cures

There is no doubt the Obama Administration will rely heavily on the support of the health care industry to help implement the recently passed health care legislation. Yet while the dependence on industry to fund research and development and to pay fees for registering new trials and drugs will help address some of the challenges with reforming our system, the industry itself is still fighting one major problem.

Specifically, the “current conflict-of-interest policies (COI), designed in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry, are placing limits on what physicians may and may not do regarding their involvement with activities and research funded by industry.”

According to members of the Association of Clinical Researchers and Educators (ACRE), these COI policies “are mischaracterizing the nature of collaboration and downplaying the potential benefits of collaborations between physicians and industry.” While there is no doubt that physicians work with industry (94% reported some type of relationship with the pharmaceutical industry), Endocrine Today interviewed experts to clarify the issues regarding the supposed conflicts of interest in medicine.

Organizations push for change

Organizations such as the American Association of Clinical Endocrinologists and American College of Endocrinologists believe the relationship between physicians and industry is consistent with ethical standards and is in the best interest of patients. These organizations correctly assert 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.”

Supporting policies like these, ACRE was formed in 2008 to educate professionals and policymakers on the value of the collaborative relationship between industry and physicians and to address efforts to impose stricter guidelines and regulations between industry and physicians. ACRE does not overstate or exaggerate the risks of such relationships, it simply provides a forum for physicians and industry partners to discuss and debate the relationship between the two.

Casey Kimmelstiel, MD, associate professor of medicine, director of clinical cardiology at Tufts University School of Medicine and ACRE member, told Endocrine today that ACRE “provides education for health care professionals and patient advocates to empower them to reject this framing bias and fight those policies that undermine productive collaboration.” The organization is also charged with training our current and next generation physicians so they can promote true excellence in medical education and innovation.

Jeffrey R. Garber, MD, Endocrine Today Editorial Board member believes that ACRE is important because it provides “a voice to share information, write positions, be present at conferences, and keep the argument relevant by speaking with colleagues and opening them up to the reality that regulations on collaboration are a bad thing.” Garber is president of AACE, associate professor of medicine at Harvard Medical School and chief of endocrinology at Harvard Vanguard Medical Associations.

Criticisms of collaboration

Critics of industry-physician collaboration maintain that “a vigilant watch must be maintained, and even stricter restrictions put into place.” These opponents frequently cite data the Wazana study, another JAMA study on journal COI policies, and a systematic review of patient attitudes of research participating in the Archives of Internal Medicine. Since information on physician and researcher financial ties is becoming more publicly available, many of these studies cite the need for further research.

Accordingly, these critics and their use of evidence do not address significant research that contradicts their findings, such as a study in Academic Medicine which found no evidence that commercially supported CME activities resulted in perceived bias. In fact, Steven Kawczak, MA, associate director of the Center for Continuing Education, Cleveland Clinic, and colleagues reported a “quite low” bias level for all types of CME activities, and perceived bias was not significantly higher when commercial support is present.

Framing bias, terminology

For Michael Weber, MD, professor of medicine at State University of New York Downstate Medical Center College of Medicine, “conflict of interest implies that in order to receive the funding to do the research, the physician had to do something that had an adversarial or negative impact on the patients he was caring for.”

If a doctor shows that a cancer treatment prolongs somebody’s life by six months with this or that side effect, but has also shown that the treatment is beneficial, he/she can disclose a financial interest so that people know the providence of the research funding. Why, then, use the term ‘conflict?’

This implication according to Lance Stell, PhD, professor of philosophy at Davidson College and a clinical professor of medicine at the University of North Carolina School of Medicine, makes the term inherently negative. Dr. Stell recognized that this framing bias has rhetorically reconstructed what were once termed “relationships” between physicians and industry and has instead designated them as conflicts.

According to Daniel S. Duick, MD, an endocrinologist and immediate past president of AACE, “using this broad-based term is a fallacy, and it presents and connotes a negative image of something that, in reality, is almost always a positive thing.”

Thomas P. Stossel, MD, professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, also noted that the framing bias misattributes interests to the interested parties involved in the collaboration. Dr. Stossel noted that in “medicine, there is an alignment of interests, and it is win-win (physician-industry collaboration) if it adds value.”

Regulations on collaboration

Over the past few years, and included in the recently passed health care legislation, laws have forced more transparency and ethics between physicians and industry support. In response, many physicians have objected and complained that this control is stifling an association that has advanced medicine over the past century.

Dr. Weber noted that “not all regulations or policies regarding collaborative relationships are negative or without merit,” such as a speaker talking about a drug based on the FDA-approved product label. Some critics, such as David J. Rothman, PhD, of Columbia University, believe that physicians and industry should be kept separate.

Conclusion

In the end, patients derive benefits from collaboration between physicians and industry because without collaboration, advances in medical devices and drugs would be significantly stunted. Some commonly used drugs that came about as a result of industry-physician collaborations include calcium channel blockers, angiotensin-converting enzyme inhibitors, various statins, erythropoietin and phosphodiesterase type 5 inhibitors, vaccines, antibiotics, pacemakers, defibrillators, stents, cancer therapy, artificial hips and knees, and HIV medications. Clearly then, the benefits of the collaborations often outweigh the negatives.

Ultimately, for this progress to continue in the future, this framing bias must be eliminated, and relationships with physicians and industry must be acknowledged for what they truly are—ethical and beneficial for patients and physicians.  

Association of Clinical Researchers and Educators at the American Society of Hypertension Annual Meeting: Special Presentation

The American Society of Hypertension is hosting a session at their annual meeting featuring presentations from the Association of Clinical Researchers and Educators on Saturday May 1^st at 3:30pm – 5:00pm at the Hilton Hotels and Towers in New York City. 

 

The session features presentations from Tom Stossel, MD Harvard, Lance Stell, PhD, Davidson College and Jeffrey Garber, MD Harvard.

 

They will be discussing the source of the attack against industry, the roots of conflict of interest, and the important relationship that industry and organizations maintain.

 

For Details:

 

Date: Saturday May 1st

Time:  3:30 PM – 5:00 PM •

 

Location:  Hilton Hotel and Tower

    Beekman Parlor

1335 Avenue of the Americas
New York, New York
USA 10019

 

Cost:        $50.00/per person (session only)

 

Physician Industry Relations

 

Chairs: Henry R. Black, MD, New York, NY and

Michael A. Weber, MD, New York, NY

 

3:30 PM The Physician/Industry Relationship:

Why is it Under Attack?

http://www.hilton.com/en/hi/groups/personalized/NYCNHHH-ASH-20100426/index.jhtmlThomas P. Stossel, MD, Boston, MA

 

4:00 PM Conflict of Interest: What Does it Really Mean?

Lance K. Stell, PhD, Davidson, NC

 

4:30 PM Are Academic Physicians, Individually and as

Organizations, Too Dependent on Industry?

Jeffrey R. Garber, MD, Boston, MA

 

Registration is available on site, and everyone is welcome.

Cardiology Today: Conflict of Interest an Outdated Phrase for Physician-Industry Relationship?

 

An article in Cardiology Today discusses why the term ‘conflict of interest’ is becoming an “outdated phrase for physician-industry relationships.” Specifically, the article recognized that while current conflict of interest policies (COI) are designed “in theory to encourage transparency and ethicality in collaborative relationships between physicians and industry,” negative consequences can result.

 

In fact, many of the current COI policies “place limits on what physicians may and may not do regarding their involvement with activities and research funded by industry.” The result of such limitations has led “many institutions and publications to enact multifaceted disclosure and conflict of interest policies to avoid appearances of impropriety or unethical behavior.”

 

According to the newly formed Association of Clinical Researchers and Educators (ACRE), these new policies “may be mischaracterizing the nature of collaboration and downplaying the potential benefits of collaborations between physicians and industry.”

Supporters of such limitations, cite “data from 29 studies, and an often-cited JAMA review published in 2000 by Ashley Wazana, MD, an assistant professor at McGill University in Montreal.” In this study, Wazana suggested that the relationships between industry and physicians appear to affect prescribing and professional behavior, as well as continuing medical education sponsored by a drug company. Recent research, as we previously discussed from the Cleveland Clinic shows strong evidence to dispute such claims regarding CME.

 

Framing Bias, Terminology

 

Critics of the phrase ‘conflict of interest’ in the medical practice as it applies to industry-physician collaborative relationships believe the term “is fraught with philosophical and practical problems.” According to Michael Weber, MD, a professor of medicine at State University of New York Downstate Medical Center College of Medicine, “The term almost implies that in order to receive the funding to do the research, the physician had to do something that had an adversarial or negative impact on the patients he was caring for.

 

Dr. Weber told Cardiology Today “If I show that a cancer treatment prolongs somebody’s life by six months with this or that side effect, but I have also shown that the treatment is beneficial, I can disclose a financial interest so that one knows the providence of the research funding. Why, then, use the term ‘conflict?’”

 

Lance Stell, PhD, a professor of philosophy at Davidson College and a clinical professor of medicine at the University of North Carolina School of Medicine, noted that there is a “negative connotation inherent in the term.” Specifically, the term “conflict” established a “default moral judgment” and “makes salient one aspect of incentive misalignment and risk” while negating other “offsetting incentives, alignments and common interests.”

As a result, Stell asserted that this framing bias has “rhetorically reconstructed what were once termed “relationships” between physicians and industry and has instead designated them as conflicts.”

 

Thomas P. Stossel, MD, a professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, noted another problem in the current framing of industry-physician collaboration: “the misattribution of interests to the interested parties involved in the collaboration.”

 

Dr. Stossel told Cardiology Today that the current frame creates somewhat of a socialistic view that “there is a winner and there must be a loser.” He clarified that “in medicine, this view does not exist because there is “an alignment of interests, and it is win-win if it adds value.”

 

Regulations on Collaboration

 

Despite this framing bias, states such as Massachusetts, Vermont and Minnesota, as well as universities such as Harvard and the University of Wisconsin, have passed laws that place strict limits on the interactions that physicians can have with industry. In fact, Dr. Weber noted how the “University of Wisconsin, has proposed rules that would prevent their faculty from participating in educational activities that are funded by industry.” He asserted that such a rule “seems to not be based on any logic.”

 

Dr. Weber did believe that some policies, regulating speakers who are paid by industry can prevent problems for the speaker, patients and for industry. He asserted that a company who decides to hire a doctor to do promotional talks on a drug is appropriate because the speaker is “obligated to only say about the drug what is FDA-approved in the labeling of the drug, which is a reasonable requirement.”

 

Fruits of collaboration

 

Dr. Stell asserted that “patients ultimately end up deriving benefits from collaboration,” citing devices that came about as a result of industry-physician collaborations such as the “intra-aortic balloon pumps, multilumen catheters, trans-esophageal echocardiography, portable defibrillators, pulmonary catheters, arrhythmia ablation technologies and many others.” He also listed some commonly used drugs on the list including calcium channel blockers, erythropoietin, various statins, ACE inhibitors and PDE5 inhibitors, among many others.

 

Dr. Stossel recognized that because of industry-physician collaboration, “Medicine is incomparably better than when he started out practicing about 40 years ago.” He further emphasized that medicine today is better “not because doctors are now somehow more ethical or have been more heavily regulated – rather, it is because of the products that they have developed and gotten through their collaborations with industry.”

 

In agreement with his statements, Casey Kimmelstiel, MD, an associate professor of medicine and director of clinical cardiology at Tufts University School of Medicine, noted that “the benefits of the collaborations often outweigh the negatives.” Dr. Kimmelstiel emphasized that “the overwhelming majority of advances in medicine in the past century have been due to the collaborative relationship between industry and physicians – drugs, devices, vaccines, antibiotics, pacemakers, defibrillators, stents, cancer therapy, artificial hips and knees, HIV medications – the list goes on and on.”

 

ACRE

 

In 2008, ACRE formed in response to the growing criticism of physician-industry relationships, with the mission of educating professionals and policymakers on the value of the collaborative relationship between industry and researchers. ACRE also aims to provide a forum for like-minded physicians and industry partners to discuss and debate the relationship. Dr. Kimmelstiel added that “The goals of ACRE are really to highlight the value of collaboration between health care professionals and industry, as well as to provide education for health care professionals and patient advocates to empower them to reject this framing bias and fight those policies that undermine productive collaboration.”

 

He further noted that “The long-term goals of ACRE are to promote efficient patient care and efficient, effective collaboration in the pursuit of innovation that is based on good science. Most importantly, perhaps, it is to help train our current and next generation of physicians so that they can promote true excellence in medical education and innovation.”

Ultimately, over the past few decades, the only thing that has changed between physician-industry relationships is that they have grown to help and treat more patients with new research, advances and innovations. As a result, calling such relationships ‘conflicts’ today should be seriously reconsidered, before the next thing to change is that we see less relationships, and thus helping less patients.