Policy and Medicine

Cardiology Today: Conflict of Interest an Outdated Phrase for Physician-Industry Relationship?

 

An article in Cardiology Today discusses why the term ‘conflict of interest’ is becoming an “outdated phrase for physician-industry relationships.”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.

Minnesota Legislature: Physicians and Pharma vs. Insurers and Prescription Project

This weekend’s Minneapolis Star Tribune highlighted today’s hearing in the Minnesota Legislature between a consumer-insurer coalition on one side and a coalition of physicians and drug companies on the other.   

The article states that while “Americans dole out billions of dollars for prescription medications each year, drug makers are also doling out billions of dollars to influence the doctors who prescribe them.” Such a claim is problematic for many reasons, and ignores the fact that without such drugs, millions of Americans would not be as healthy or living as long.

The joint hearing of the Commerce and Labor and the Business, Industry and Jobs committees will begin debating three bills (which we mentioned previously). The bills are “designed to improve doctors' prescribing skills, reduce the influence of pharmaceutical companies -- and perhaps reduce overall drug spending by consumers.”

For example, one bill allows the state commissioner of Health, “along with the state Board of Phrmacy and the University of Minnesota's medical and pharmacy schools, to develop a drug-education program for doctors, pharmacists and other health care professionals.” Essentially, this program would limit drug company representatives from talking to physicians about drugs that are clinically shown to be effective in favor of "evidence-based medicine." The article claims that evidence-based medicine involves doctors who “make medical decisions based on unbiased scientific information rather than information from drug companies.”

Excluding truthful information from drug company representatives about research and clinical studies for brand name drugs, in favor of generic drugs, just to save money, hardly seems unbiased. Physicians must be able to hear all sources of information equally, and weigh the potential costs, risks and benefits of all drugs to save their patients foremost, not money.

Proponents of the bills feel that the drug industry’s spending of $7.2 billion a year on marketing to physicians, “compromises the quality of health care and inflating.” Various groups, such as the newly formed Minnesota Prescription Coalition, a diverse group that includes AARP Minnesota, insurers HealthPartners and Medica, labor unions, hospitals and consumer groups, supports the proposed legislation.  

Review of their website shows that the Minnesota Prescription Coalition is primarily funded under through with Community Catalyst and the Prescription Project of Pew Charitable Trusts.

 

The Prescription Project based in Boston Massachusetts and their parent Community Catalyst are also the only contacts and lists none of the groups discussed in the press release.  Including the cell phone contact information for Peter Wyckoff, National Consultant – Prescription Access and Quality Community Catalyst - The Pew Prescription Project  (I guess he is lonely and wants to chat)   

It is interesting to note that the insurance companies are showing their stripes as being against newer medications and treatments in an effort to get the focus off their overhead costs and onto the costs of treatments which in the end can lead to tremendous savings to society.

For example a patient who is treated with a medication to prevent a heart attack or treat a stroke, may live five to ten years longer than those who do not.  In those post event years they can contribute back to society through taxes and productivity which is rarely if ever discussed in the cost analysis.

Supporters such as Peter Wyckoff, a coalition spokesman and employee of the Prescription Project, believe that the proposed bills will “save money in the long run and improve quality and safety in prescribing.”

Against the proposed legislation are various members of the health care profession including the pharmaceutical industry, doctors, and members of the Association of Clinical Researchers and Educators (ACRE). The article noted that ACRE recently co-sponsored a forum in Minnesota on "Restoring the Value of Collaborative Relationships in Medicine."

One member of ACRE, Dr. J. Michael Gonzalez-Campoy, a Minneapolis endocrinologist, and past president of the Minnesota Medical Association told the Tribune that the “relationship between doctors and drug companies is often misunderstood by the public.” He further emphasized that doctors would not be able “practice medicine if it weren't for pharmaceutical companies."

ACRE also provided written testimony to the hearing outlining the harm that can happen to patients and medicine from the proposed bills including:

· “Generics all the time” is a false economy.

o   Newer medications are more cost efficient in the long run. They represent an investment in future health.

 

· Medical care decisions should be made by physicians and patients together, not anyone else.

o   Physicians, especially in greater Minnesota and large medical groups in metropolitan areas, deserve free access to all sources of medication information with no restrictions – not from the State, not from HMOs, not from the federal government.

 

· Excellent medical care is built on this exchange of information, and partnerships between physicians and industry are integral to it.

 

· ACRE believes that the collaborative relationships between physicians and industry are moral, ethical and legal, bring value to medicine and to patients, and result in excellent patient care.

 

· ACRE does not condone unethical behavior in medicine, the examples of which are exceedingly rare.

 

 

· ACRE affirms that the work product of physicians includes clinical research and education, and that physicians should be paid for the work they do.

 

· It is not up to the legislature to determine the contractual arrangements of physicians for the work they do.

Still, critics of industry-physician relationships believe that drug companies are only out to sell their product because they know doctors have “little time to comb through complicated clinical studies and journal articles, and crave "unbiased" information.”

In response to such claims, Marjorie Powell, senior assistant general counsel for the drug industry group PhRMA, noted that the proposed legislation is “overkill” because insurance companies already prescribe generics when they are available. She further emphasized that "two-thirds of all prescriptions filled in the U.S. are with generic drugs, so it's not clear that an [education] program is of any value to physicians."   For Minnesota the generic prescription number is closer to 80%.

States such as Pennsylvania and New York have already “adopted similar education programs,” which have resulted in savings, according to Stephen Schondelmeyer, a University of Minnesota pharmacy professor who studies drug pricing. The article noted that these savings occur because the programs encourage the use of “cheaper generic drugs instead of more expensive brand-name medications.”

Dr. Gonzalez-Campoy noted however, that this type of saving is not necessarily a good thing because the "rising health care costs have focused the discussion away from the value of treatments to the cost of pills." He further asserted that while ACRE is not against the use of generic medications, the organization supports the premise that physicians should be using “newer, better treatments when they are more appropriate for patients," regardless of cost.

Also being debated at the hearing is legislation that will prohibit "pharmaceutical data-mining," where “drug companies buy doctors' prescribing records from a third party and use the data to target their marketing efforts with individual physicians.” While the creators of this bill believe it causes physicians to receive biased information, PhRMA's Powell noted that "because pharmaceutical companies have the most current information about medicines, both new and existing, it's very important that they get that information to the physicians who are actually prescribing the medicines.”

Ultimately, it should be noted by media sources and public officials that when considering the impact this legislation will have on patients and doctors, there must be a distinction between hiring physicians for consulting and customer education, and merely paying doctors to prescribe. The interactions between the drug industry and physicians are crucial for the health and livelihood of our patients, and without such exposure, how else will physicians know what to prescribe?

 

Association of Clinical Researchers and Educators, Minnesota Meeting January 23rd

 

To address the concerns of Minnesota based physicians, the Minnesota Center for Obesity, Metabolism and Endocrinology Foundation (MNCOME) and the Association of Clinical Researchers and Educators (ACRE) are hosting a forum to explore the value of physician-industry collaboration for medical education, research, and patient care. Speakers will include leaders from ACRE, the American Association of Clinical Endocrinologists (AACE) and Minnesota’s medical community.

 

The forum will also include presentations from patients, patient advocacy group representatives, legislators and medical industry members. Media representatives are cordially invited.

 

Date:      Saturday, January 23^rd

Time:         9am – 4pm

Location: MNCOME Conference Center –

880 Blue Gentain Road, Suite 155

Eagan, MN

 

Speakers include:

 

Lance Stell, PhD Carolinas Medical Center

Laurence Hirsch, MD   BD Medical

Linda Carroll-Shern, JD PhRMA

Rep. Tom Huntley    Minnesota State Legislature

Steve Hodgson, MD    American Association of Clinical Endocrinologists

Ken Crabb, MD    AMA House of Delegates

J. Michael Gonzalez-Campoy    MNCOME

Patients

ACRE--MNCOME Foundation Final Program

ACRE - MN 2010 Registration Form

It will be cold (Minnesota in January) but it will be great.  Look forward to seeing you there.

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."

Association of Clinical Researchers and Educators: Academic Physicians Confront a Hostile World: The Creation of ACRE

 

Michael A. Weber, M.D., a founder of the Association of Clinical Researchers and Educators (ACRE), recently published an editorial titled: Academic Physicians Confront a Hostile World the Creation of ACRE to address the concerns about relationships between academic physicians and the pharmaceutical and device industries.

 

He noted that today, a large part of medical research and education is based on this relationship. In fact, even Dr. Jeffrey Flier, Dean of Harvard Medical School, acknowledged at ACRE’s inaugural meeting this past July that his school’s mission to promote medical education and research requires interaction with industry.

 

This interaction in recent decades has created significant breakthroughs in treating conditions such as cancer and heart disease, and their incorporation into medical practice have resulted from this partnering between academia and industry.

 

Another reason for such collaboration is “because academic physicians are uniquely qualified to identify unmet medical needs and, working collaboratively with industry colleagues, to devise and conduct the types of basic research and clinical trials that lead to therapeutic breakthroughs.”

 

Critics of such collaboration want to preserve the independence of academic physicians by pointing to the negativity associated with the costs of new developments in patient care.

 

Such a concern however, is misguided because while industry and its academic advisors develop and make new tests, procedures, and therapies available to help save lives, government agencies are left with limited budgets, and commercial health plans with financial obligations to investors. These problems for agencies and health plans are made worse when academic physicians begin teaching their practicing colleagues about the attributes of these new developments because the government does not have the resources necessary to ensure the widespread use of such breakthroughs.

 

To solve such a problem of limited resources does not require the government to start yelling “conflict,” when the reality is, agencies cannot keep up with industry.

 

As nationally recognized medical ethicist, Lance Stell, explained at ACRE’s inaugural meeting, “occurrences of conflicts are extraordinarily rare in the conduct of medical research and education activities” because empirical proof is needed to accuse a physician of such conflict.

 

Instead of conflict, Dr. Weber advocated for the use of “duality, concordance, or alignment of interests.” He even pointed to the irony of how commercial health plans offer practitioners direct monetary rewards for switching their patients from more expensive to less expensive drugs, or, possibly, for reducing their use of tests, referrals, and therapies so as to minimize the insurers’ outlays. Yet these are not considered conflicts.

 

THE CHALLENGE OF EDUCATION

 

Dr. Weber also indicated in his article that because industry has the responsibility as well as the resources to provide ongoing education in the clinical sciences, it should be no surprise that much of the information received by practicing clinicians comes from events that are funded, directly or indirectly, by industry. The idea that industry is providing promotional activities or CME for reasons other than advancing science and helping patients are misguided.

 

The promotional education programs that take place in hospitals, medical offices and other venues to provide information directly about a company’s product are regulated by the FDA. These regulations guarantee that information presented must be balanced, providing information about risks as well as benefits, and must conform largely to what is stated about the drug in its approved product label.

 

Although some pharmaceutical companies have pushed to use company-provided slides, this requirement obviously creates fundamental problems for academic physicians invited to present at such events. In response to such demands, major medical schools have now instructed their faculty members not to give such lectures unless they have meaningful control over the content. For community practitioners who attend such events, this is an unfortunate development, for it deprives them of beneficial teaching interactions with true medical leaders.

 

Instead of preventing physicians access to such education, negotiations between industry, academia, and regulatory agencies is needed to “re-create the collegial educational experiences.”

 

RE-EVALUATING CME

 

The contents of CME programs usually are created by academic faculty and are subjected to peer review (similar to an article submitted to a journal) to ensure their objectivity. Such an indication is evidence that industry has a “hands off” involvement in such events, merely serving as a provider of grants. Moreover, industry now goes to considerable pains to ensure that its grant decision processes are kept entirely separate from marketing activities.

 

Critics who believe industry support for CME results in increased sales of its products underscore the significance of these programs. Even if this were true, it is a not unreasonable proposition that if well-balanced data, presented in an unbiased fashion, affects the subsequent utilization of drugs or devices, this will very likely be to the benefit of patients.

 

What critics should consider is a report conducted by the Royal College of Physicians in Great Britain about four years ago, which “stated that the interests of patients and their clinicians are best served by close cooperation between academia, industry, and the health services.”

 

ACRE’s Role in CME

 

The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its initial 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 will be 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 will also develop a public voice that gets heard and quoted when these industry-academia relationships are attacked, as they have been in the past.

 

There already has been one such success: Dr Thomas Stossel, one of ACRE’s leaders and the chair of the Harvard meeting, was invited to testify at a high-profile US Senate hearing on CME in late July.

 

Dr. Weber concluded his support for academic-industry partnership by noting the dramatic improvements in cardiovascular medicine and patient care that have resulted in reducing mortality rates, hypertension, lipid disorders, diabetes, heart failure, acute coronary syndromes and chronic kidney disease by this collaboration.

 

Consequently, from the perspective of academic clinicians, rigorously conducted CME events in which they are free to select the content and ideas represent ideal opportunities to enhance practitioner knowledge and patient care. Any attempt by legislators (and others who regard medical education as a health–care cost driver) to prevent or limit industry support of CME could have the effect of diminishing the quality of medical practice.

 

ACRE’s members, in common with most physicians, no longer find it acceptable to let others unilaterally set up the rules by which we are expected to function in performing these vital tasks. 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.

 

More information about ACRE can be found on its Web site: http:// www.acreonline.org. The site also has information about how to become a member.

Boston Magazine Features Thomas Stossel, MD Co-Founder of Association of Clinical Researchers and Educators

Last week Boston Magazine feature the Association of Clinical Researchers and Educators in an article titled: Bitter Pills: Harvard Medical School is under fire from critics for its ties to Big Pharma. While the school tries to sort it all out, two professors battle for its soul.

They feature two Harvard Professors Marcia Angell-Relman, MD a former acting editor and chief at the New England Journal of Medicine who wants Harvard to adopt a policy of basically cutting all ties to drug makers.  In her words doctors "should have no financial interest in companies whose products they are evaluating," she argues. No stocks. No money for speaking or writing for industry forums. Drug reps shouldn't be allowed on campus.

In combating her cut all ties approach is Thomas Stossel, MD  a Harvard hematologist  and brother of libertarian journalist John Stossel. When Angell wrote an op-ed in the Globe several months ago, Stossel promptly penned a rebuttal in Forbes. When Stossel was invited to speak at a 2007 public panel on pharma influence issues, Angell blasted the choice, saying that to include him amounted to "standing the whole thing on its head." The two are "matter and antimatter," says one acquaintance. "Put them in the same room and the universe might explode."

In fact, Angell and Stossel have been in the same room at least once. At what should have been a fairly dry meeting of the American Society of Hematology in 2002, they gave dueling talks. Angell spoke in broad terms about the "dissolving" boundaries between academia and industry; the fact that medical meetings had become "a massive trade show...with free goodies." Stossel got more personal. "I don't need to feel morally superior to drug companies," he said. "Let's object to sanctimony." Today, in person, he's even more barbed: When it comes to research credentials, he says, "I don't even consider myself in the same universe as Marcia Angell."

Like Angell, Stossel is well aware that Harvard physicians pull in a lot of money from drug companies. Unlike Angell, he sees that as a good thing. Stossel traces improvement in Americans' health directly to breakthroughs funded by the pharmaceutical industry. Limit doctors' interactions with that industry, he argues, and you limit the power of the market to drive innovation.

Stossel also argues that the various controversies concerning Harvard and Big Pharma are overblown. The Pfizer rep with the cell phone wasn't plotting a corporate takedown of the student protesters; he was taking photos of a public event out of personal interest. The professor who didn't reveal his links to cholesterol drugs wasn't technically doing anything wrong; Harvard only now requires that doctors disclose conflicts of interest in all public venues, including classrooms. 

Stossel even refuses to condemn Biederman, the child psychiatrist, though he won't quite defend him, either. "The second you show me solid evidence that he should have backed off on some conclusion and didn't, he's toast," says Stossel. "But I bet what [the ongoing investigation] will find is that he didn't do anything wrong." Besides, he points out, having one bad apple among almost 10,000 faculty members is a risk worth taking. "We have to tolerate some bad behavior if we want progress," he says. 

This past summer Stossel cofounded the Association of Clinical Researchers and Educators (ACRE), an advocacy group for doctor/drug company partnerships. It has been ruthlessly parodied—most notably as Academics Craving Reimbursement for Everything—but it has also attracted some followers, even among Harvard med students, some of whom say they're uncomfortable with the protesters' divisive stance. Angell's acolytes are "a vocal minority," says Vijay Yanamadala, a med student who sides with Stossel. "We all agree on more than we disagree."

This article outlines that Harvard is currently revising their conflict of interest policies but will not be cutting back on all ties to industry as some like Angell-Relman would like.

Milwaukee Journal Sentinel: Doctors’ Presentations Help Patients

Today’s Milwaukee Journal Sentinel includes an editorial by Thomas Stossel, MD titled Doctor’s Presentations Helps Patients.   The editorial is in response to a series of articles and editorials in the newspaper critical of physician industry collaboration. 

Despite arguments to the contrary, doctors should be paid (Editorials, "Get off the gravy train," Oct. 7). They should be paid to bring specialized knowledge and experience to their patients. They also should be paid to bring specialized knowledge and experience to their colleagues.

Both exchanges create value and improve patient health. Hollow accusations should never obscure this fact. Promotional presentations by physicians should not be banned; they should be celebrated, for patients' sake.

Medicine, although rooted in science, is still an art. Ask any physician. And like every art, mastery comes from experience, not from simply reading manuals. Physicians are no different from other artists.

They need more than voluminous texts to practice their art. They need to hear from colleagues who have real-world experience with the medicines, devices and diagnostic tools that provide the foundation of modern medical care. Banning promotional presentations, where a presenter and the audience are allowed to engage in free and open dialogue about the benefits and risks of medical products, limits the opportunities to exchange these experiences.

The Journal Sentinel Editorial Board claims that when physicians promote products, "they risk their credibility with patients, risk clouding their judgment, risk overusing a treatment and risk driving up the cost of medicine." Everyone can agree that these risks do exist - nothing in life is without risk. The more important question, however, is whether these risks translate into harmful behaviors or consequences to patients? The resounding answer is no.

Polls repeatedly show that physician credibility is based on the care they provide, not the sources of information they access or how they educate their colleagues. Moreover, there is near consensus that non-financial factors such as gaining tenure, publishing and climbing the academic hierarchy are much more likely to prompt unethical behavior among academic physicians, who represent the majority of promotional speakers. These influences require much closer examination.

Of even greater importance, however, is how these activities affect patient care and patient health. Contrary to what critics would have us believe, under-treatment due to limitations in physician knowledge and experience is more detrimental to patient health and more likely to drive up costs.

Take diabetes as an example. The prevalence is skyrocketing, its causes and consequences are well understood and treatment options are many. Nonetheless, under-treatment is the rule, rather than the exception.

Although 71% of diabetic patients have high blood pressure, less than half get sufficient treatment to reach treatment targets. Failures such as these impart enormous costs on the quality of life, productivity and our nation's financial health. Severing physician interactions only contributes to these unnecessary costs.

The University of Wisconsin has a rich history of leadership in the medical field, and it has the opportunity to continue to lead. We hope it will foster a culture that values exchange of information and experience and puts patients back at their rightful place as the focus of medical policies.

Thomas P. Stossel, M.D., is ACRE co-founder and executive committee member, an American Cancer Society professor of medicine at Harvard Medical School, director of the Translational Medicine Division at Brigham & Women's Hospital. He is a founding scientist and director of Critical Biologics Corp. and a director of Velico Corp. He has contributed his views on physician-industry collaboration as a consultant to Merck, Pfizer, Amgen, Bristol-Myers Squibb and IMS Health.

Association of Clinical Researchers and Educators: Publish Presentations

For those of you who were unable to attend the Association of Clinical Researchers and Educators (ACRE) Charter meeting on July 23^rd at the Brigham and Women’s Hospitals.    A complementary Webcast of the event is now available on the ACRE website at  http://www.acreonline.org/eng/pages/annual-meeting.

Presentations include:

CONFERENCE WEBCAST     AGENDA HANDOUT     DISCLOSURES

Welcome and Introduction

Welcome and Introduction 

Thomas P. Stossel, MD

Jeffrey S. Flier, MD 

Principles of Interest

Independent Medical Judgment and Industry Influence 

Lance K. Stell, Ph.D.

Conflicts of Interest, Authorship and Disclosures 

Laurence J. Hirsch, MD

Value of Collaboration for Patients

LAM Treatment Alliance

Amy Farber, Ph.D.

Value of Collaboration to Patients

Barton A. Kamen, MD, PhD

Value of Collaboration to Patients

Tracy L. Olson

Q&A: Value of Collaboration to Patients

Addressing Regulatory Challenges

Massachusetts: Complying with a New Complex Law

State Representative Michael J. Rodrigues

Lawrence W. Vernaglai, JD

Sarah Elisabeth Curi, JD, MPH

Physician Payment Sunshine Act

Thomas Sullivan

A Consequence of Gift Laws

J. Michael Gonzalez-Campoy, MD, PhD, FACE

Value of Promotional Speaking to Speakers and Listeners

The Value of Industry

Carey Kimmelstiel, M.D. 

Value of Promotional Speaking to Speakers

Arnold I. Friede, JD

Why ACRE is our best chance to take back ...

Michael A. Weber, MD

Value of Collaboration for Professional Medical Societies

Value of Collaboration for Professional Medical Societies

Jeffrey R. Garber, MD, FACP, FACE

A Necessary Alliance

Henry R. Black, M.D. 

Value of Collaboration for Medical Innovation, Training Programs and CME

Value of Collaboration for Innovation

Thomas J. Fogarty, MD

Value of Collaboration for Innovation

Bruce Gingles

Academia and Industry

Avi B. Markowitz, MD

Joslin Professional Education Consortium - JPEC

Richard S. Beaser, MD

 Value of Collaboration for Education to  Physicians and Patients

 The Myeloma Story

Rafael F. Fonseca, MD, PhD

 Value of Collaboration for Education

Paul G. Richardson, MD

Conclusion and Future Plans

Closing Remarks

Jeffrey R. Garber, MD, FACP, FACE

Membership

In addition, ACRE’s membership registration page is available for those interested in Joining ACRE, the membership fee is $200/year.

ACRE: Washington Post - Can You Trust Your Physician

The Washington Post featured an article around physicians working with industry and how patients should ask their physicians about those relationships titled: Probing Doctors' Ties to Industry

In the article they make the claim that 94% of physicians have relationships with industry and question if patients can trust physicians.

The fact that doctor’s work with industry does not mean conflict. It means that physicians not only understand the types of treatments and medicines they provide (from the experience they gain with industry), but that they also have worked with those drugs and devices, and have conducted research and clinical trials with them.

Conversely, while consumer surveys might show what the publics opinion about physician-industry relationships are in general, these surveys fall short of the most important question: whether any sort of relationship or gifts has any impact whatsoever on the effectiveness and efficiency of the treatment patients receive.

A better question that could have asked is: If your physician worked with industry, which gave them the necessary research and clinical experience with a drug or device he or she may prescribe you, would you be more or less confident in your physician? We would hope any reasonable person would choose a physician who has experience with a treatment—especially one created by industry—verses a physician playing “Operation.”

Critics like Daniel Carlat, a Massachusetts-based psychiatrist, think patients should bring up industry payments with their physicians indirectly by mentioning the media. That idea however is almost as ridiculous as Mr. Carlat himself. The media has one goal: to make money whatever way they can. Unfortunately, the media’s biased nature of reporting physician payment industry has a long record of jumping to conclusions and selectively choosing information to portray legal activities as unethical. Industry’s main goal is to help patients.

Furthermore, the responsibility of any “physician is to facilitate the development of new therapies by "working with many pharmaceutical companies.” The ultimate goal of any physician as well as the industry is to treat patients because "The trust of our patients is so important.” Specifically, doctors “never want a patient to not take a medicine because they are concerned a physician might have a financial interest."

That is why representatives from the Association of Clinical Researchers and Educators (ACRE) stated in the article that "Once the information is out there . . . patients will realize that there are a lot of physicians involved in [relationships with industry] for the betterment of patients," said Rafael Fonseca, a hematologist and the deputy director of the Mayo Clinic Cancer Center, as well as a member of the steering committee for ACRE. Some physicians, like Avi B. Markowitz, a medical oncologist at the University of Texas Medical Branch in Galveston, who is also on the steering committee of ACRE, believe that “doctors are entitled to their privacy.”

Ultimately, Physician and industry relationships are necessary, and good for research. Moreover, as Steve Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic put it perfectly: "We can't lose sight of the fact that it is potentially beneficial [to the public] for industry to interact with physicians, because someone needs to develop these drugs."

We need to focus on developing drugs and educating those who prescribe them on the right patients to use them on.  In the end the physician and patient both benefit from those new therapies and education around them.

Association of Clinical Researchers and Educators: Misguided Students and Frightened Competition

The misguided voices of students on college campuses are a part of American culture we are too frequently reminded. Although many positive accomplishments can come from a free flow of ideas, and academic freedom, student organizations tend to be drastically overdramatic, and illogical. Such is the case of the American Medical Student Association (AMSA).

Recently, AMSA issued a press release to announce that they reject the objectives of the Association of Clinical Researchers and Educators (ACRE), a newly formed organization that seeks to limit conflict of interest regulations, and since its young existence, has only had one formal meeting.

Instead of allowing the voice of reason into their organization, and to hear from students and physicians on all sides of the spectrum, AMSA chose to be radical at a time that seems all too convenient for them: healthcare overhaul.

Is there a sense from the medical student body that more spots could be opening up in medical schools? Is there a chance that more money could be given for residencies, fellowships, loan forgiveness, and primary care? Those chances might be more likely for present medical students if they support the current government pushed initiatives. Consequently, what these ‘physicians-in-training’ have yet to realize in their course of education—or have intentionally been prevented from learning—is that industry enhances the outcomes for patients, and makes science and technology more effective with devices and medicines.

Interestingly, instead of objectively looking at the benefits from an organization like ACRE, AMSA has gone to the same extreme politicians have with healthcare reform, and look how far Congress has gotten with that. I guess most of the AMSA students were not paying attention to ACRE’s first meeting last week when the Dean of Harvard Medical School encouraged the organization to create a healthy debate regarding the role of industry and academia in medicine and research.

AMSA was more focused on asking the medical profession to continue to reduce the influence of both the pharmaceutical and medical device industries regarding promotional activities. What they will soon realize after leaving medical school is that the same ‘influence’ of industry they complain about as students, will be their savior when patients are in need, and training or extra funding is sought.

Moreover, while AMSA National President, Lauren Hughes, M.D., M.PH., believes that “ACRE is truly behind the times,” with regard to reforming conflict of interest policies, but she must not be familiar with recent legislation and laws that essentially ban industry from research and academia. Do we need to remind Dr. Hughes that not all conflicts are conflicts of interest?

As a leader, Dr. Hughes should be advocating for a balance in medical education and for students to see the benefits—which are indisputable—of using industry to fund and support new advances in medicine, clinical trials, continuing medical education, and devices.

Nitin Roper, a fourth year medical student at the University of Connecticut said he “was disappointed to find that the majority of the speakers failed to acknowledge that conflicts of interest even exist.”

Comments like these underlie the real problem: students and physicians who advocate a strong anti-collaboration stance do not even look at the issue neutrally.

Students assume that problems exist from what they are told as students and residents, not as business owners, corporations, researchers, or when they are supporting a family.

With the decreasing reimbursement rates for doctors, the uninsured, and skyrocketing healthcare costs, these students should be considering the support from industry as a blessing, before they take their business elsewhere and these ‘business people-in-training’ spending all their time figuring out how to collect fees.

AMSA seems dead set on stopping all involvement with industry, last year they made a big deal even stating at a Senate hearing last month giving this example:

A group of such students in their first year at Harvard sat in class one day last spring, listening to a faculty member lecture about treatment options for a rare and deadly form of cancer. When this faculty member advocated for the use of a new, less-researched, and expensive drug to be the first-line of treatment for this cancer over well-studied, effective, and cheaper alternatives, the students wondered why. They googled him and discovered he was a paid consultant for the drug company that makes the expensive new drug, yet the faculty member had not disclosed this fact during his presentation. After negotiations with the administration, a large group of students rallied to call for increased transparency of industry-medicine interactions and an end to conflicts-of-interest in their medical education.

What the AMSA students failed to disclose themselves is that for the 40 year old cancer therapy they referred to, life expectancy is up to 3 years less than those treated with the newer drug. Well conducted randomized studies have been performed such that at this point it is considered no longer a standard of care to prescribe the older therapy for newly diagnosed patients with this disease.

Moreover, the context of the incident was also incorrectly presented - both temporally and otherwise. The meeting was in the fall of last year, the faculty member was discussing the case of his patient who was actually sitting with him and with the students, and not in a traditional lecture format. There was no requirement for disclosure at the time, a point not made in the description to the Senate, and arguably I would suggest doing such a thing in front of the patient could, at best, be described as insensitive.

In my opinion, it is unethical for AMSA to continue their quest against industry and ignore facts to the contrary that new drugs are better and increased competition (including “me too” drugs) actually bring down and do not increase the cost of drugs (this is the point that I advocate for – that economics classes be added to the Medical School curriculum). It is also wholly inappropriate for an organization such as AMSA to misrepresent facts to anybody, let alone the United States Senate.

Other blogs also seem to be attacking ACRE. The Carlat Psychiatry Blog noted that the first ACRE meeting “made clear at the outset that the goal of ACRE is not to repeal the recent gift ban and disclosure law passed by the Massachusetts Legislature. Rather, ACRE will act as a forum for preventing further restrictions on industry academic interactions,” which are detrimental to medical research and treatment.

The Prescription Project devoted space on the bi-monthly blog postings to the meeting and included a quote from J. Michael Gonzalez-Campoy M.D. “Nobody is holding the press accountable for the harm they have done.” “My patients are being harmed by biased reporting,” he said. Overall the Prescription Project attempted to portray ACRE as anti-disclosure which from the outset the group has endorsed disclosure, and at the meeting just brought up instances where there were negative side effects to that practice.

Ultimately, Dr. Carlat’s attacks on ACRE are at best, misguided. The success of the first ACRE meeting was in establishing a purpose and principles to guide their goals and should be applauded not only by industry and physicians, but by patients who will gain access to more effective and efficient treatments.