Policy and Medicine

The Benefits of Universities and Biotech Working Together

Over the past century, we have seen drastic and positive changes in the way our health care system operates, largely because of the modern advances in science, medicine, technology and research.  Much of America’s progress has come from the laboratory of private industry as well as academic medical centers and research institutions.

However, over the past several years, there has been a constant strain on progress in the life sciences and medical industry.  Two separate, but related reasons have caused this.

First, the declining economy.  The recession and the huge hit the American economy took have affected all industries.  The effect is especially widespread in state budgets and at universities. As a recent article in Xconomy noted, “These are hard times at universities in America … [and] State support is dwindling, tuition is booming, and federal research dollars are in jeopardy.”

Second, is the increased scrutiny on academic-industry collaborations, coupled with overly strict and intrusive institutional policies that have prohibited and stigmatized the value of such relationships.

Yet, the article noted that, “U.S. academic research centers are still the driving force for some innovative new medicines, like always.” In fact, the article pointed to one university in particular, University of California at San Francisco, which is under the leadership of Chancellor Susan Desmond-Hellmann.

Desmond-Hellmann, a biotech industry star from her days running drug development at Genentech, “has her work cut out in her third year as UCSF’s chancellor.”

UCSF is a complex, 23,000-employee enterprise that does everything from studying the basic functions of stem cells to helping discover new drugs to treating patients. Starting in August 2009, she’s had the unpleasant job of overseeing furloughs, layoffs, and multi-million-dollar budget cuts. She’s said no, repeatedly, to promising new scientific initiatives.

But she hasn’t been stuck on the defensive the entire time. UCSF has struck a number of creative partnerships with companies like Pfizer, Sanofi, and Bayer, which are being closely followed at other universities. UCSF has also found a way, with the help of some big-time philanthropy, to break ground on two ambitious projects—a $1.5 billion hospital complex and a $200 million neurosciences research facility in the Mission Bay district. There in the same neighborhood, the university has also continued to support QB3, an incubator where academic scientists are starting companies that test whether their ideas just might have what it takes to become new drugs, devices, or diagnostics.

Xconomy times interviewed Desmond-Hellmann to learn about her plans and some of these themes. Desmond-Hellmann said she has a 3-year plan with measurable goals that she says will make her and her team clearly accountable for delivering what they promise.

She asserted that, “At a terrible time, with a rotten California economy, a rotten national economy, a rotten state of the world, people will see there was a medical center, an academic center in California, that positioned itself to have its best days.”

What was most important about Desmond-Hellmann’s interview was her recognition that, “Working in collaboration with pharmaceutical companies is definitely a part of the future of advancing health.” She maintained that, “financially, these deals are small potatoes, and aren’t going to close any budget gap.” For example, “even if UCSF researchers made a breakthrough cancer drug that generates billions of sales per year, it would likely only throw off a royalty stream to the university worth a few million a year—nice, but not exactly a big deal for a multi-billion-dollar institution.”

Nevertheless, Desmond-Hellman asserted that, “these collaborations are about improving the flow of basic research through development.”  And these collaborations are important because academic centers need to be able to prove that they have discovered a breakthrough drug that helps people live longer, better lives, instead of just publishing papers.

Unlike most university leaders, Desmond-Hellmann knows first-hand how much time, money, and risk is involved in creating something new to improve health. And she knows about the tensions between academia and industry. While some, in particular at UCSF, are against academic-industry collaboration, the nature of the economy and regulatory environment shows a tremendous need for these relationships.

Moreover, while industry research and development operations may be big, they are also feeling the same pressure to make cuts as universities. Accordingly, “What’s needed now are the creative partnerships, where someone knowledgeable about the whole process (like maybe a Desmond-Hellmann) steps in and finds a way to more seamlessly bring together industry and academia around what they have in common:” helping patients through new treatments.

The author noted that, “The old way of doing things doesn’t really work anymore. Often, some of the best research ideas would get handed off from academia to a company at a very raw stage of development. But few venture capitalists are funding startups at this early stage of development these days, and Big Pharma R&D has always tilted more heavily toward D than R. The economy has put more pressure on companies to tilt that balance even further away from research, and more toward late-stage development that has a chance to bear fruit in the near-term.”

As a result, the author asserted that, “Universities need to recognize this is how things are” and “if they want to truly translate their innovations into products that help patients, they will have to carry the research a little further downfield themselves.” Fortunately, “some Big Pharma companies have already shown they are willing to sponsor this kind of on campus work at UCSF and elsewhere.”

While “some academics sneer at this late-stage research/early-stage development work,” Desmond-Hellmann recognized that, “There’s a technical competence in taking a discovery from a lab and turning it into a medicine.” She added that, “It’s embarrassing that people don’t honor that technical competence.”

The author predicted that, “If Desmond-Hellmann can persuade her colleagues on campus to rally around this idea—that it’s about science that can impact health, not just science for the sake of more science and grants—then this initiative will be a huge success.”

Ultimately, it was “Academia that gave birth to the biotech industry in the first place, during another decade of recession and malaise: the 1970s.”

Now is the time to create “something equally as big,” despite all the economic challenges, but this can only happen if people in academia and industry can set aside some of their small differences and truly work together.

Dermatology Residents Believe Interactions with Industry are Ethical

According to a recent survey, “more than 70% of dermatology residents and program directors say they believe that it is ethical for residents to interact with the pharmaceutical industry.”  The results were presented during a resident forum during a meeting that was sponsored by Galderma.

The study, conducted by Dr. Erica Linnell, under the direction of Dr. Vincent DeLeo – both of the department of dermatology at St. Luke’s-Roosevelt Hospital Center in New York – assessed whether residents and program directions believe interactions with the pharmaceutical industry affect prescribing patterns among residents and whether they think such interactions are ethical. Dr. Linnell had no conflicts of interest.

The authors “found that most residents have significant interactions with pharmaceutical representatives and most believe that such activities are acceptable in certain circumstances, which is similar to survey results of other specialties, said Dr. Linnell.”

Of the 114 survey respondents from Accreditation Council for Graduate Medical Education (ACGME)-approved programs, 50% were chief residents, 37% were program directors, and 13% were first-, second-, or third-year dermatology residents or associate program directors.  The 17-question electronic survey found that:

-       73% of residency programs accept pharmaceutical support

-       68% accept educational materials

-       55% accept drug samples

-       55% accept funds for travel and registration at national meetings

-       27% accept private lunches or dinners

-       25% accept food for conferences and

-       5% accept pens, notepads, and other office supplies.

A total of 87% of survey respondents reported that the residency program at their university had guidelines for interacting with the pharmaceutical industry. When asked about the guidelines, 60% of respondents reported that interacting with pharma was "acceptable in certain circumstances," 25% reported that it was "never acceptable," 8% reported that is was "not acceptable but not discouraged," and 3% reported that it was "acceptable and encouraged."

When it came to respondents’ personal beliefs, 71% reported that interacting with pharma is "acceptable in certain circumstances," 13% reported that it is "acceptable and encouraged," and 9% reported that it is "never acceptable."

Of the respondents, 55% reported having on-site meetings with pharmaceutical representatives, and 57% reported that they believe that such meetings are appropriate. Off-site meetings were reported by 62% of respondents, with 63% believing that such meetings are appropriate. Most off-site meetings (91%) were reported to be dinner with a lecture.

Survey participants were divided on whether they thought interactions with pharma affect prescribing patterns; 54% said yes, while 46% said no.

A total of 71% of residents reported that it is ethical to interact with pharma and explained that they believe it is important for residents to learn about new medications.  The 29% who say they believe that it is not ethical to interact with pharma explained they believe it leads to biased prescribing, that residents are too easily influenced by pharma representatives, and that accepting gifts and food without educational value is wrong.

Despite this small minority, this kind of strong evidence clearly shows the important role that industry plays in all areas of medicine and healthcare, particularly specialty areas.

A Hard Look at Physician-Industry Relationships and Ad Hominem Attacks by Critics

 
Arguing against science is difficult, so what we have seen lately is rather than arguing the science and eventual benefit to society, attacks on the character of those delivering the science.  This sums up the entire conflict of interest in medicine debate.  It is taking the easy way as opposed to the principled way of debating an issue.

The core principle of universities is that, “the pursuit and free exchange of ideas is vital and uplifting, and efforts that seek to impose a particular viewpoint to the exclusion of others should be fiercely resisted.” 

Today however, many of our universities, medical schools, and academic medical centers are following short of this principle by allowing the concerns of a few overpower the agenda.  A recent article from Forbes explained how one group, the Pharmascolds, is leading a movement to “impose a particular viewpoint” on medical students, faculty and the greater public.

As the author pointed out, Pharmascolds are “critics who worry about university/industry interactions,” and “constriction of academic freedom is typically cited as a key concern.” 

To the Pharmascolds, “industry represents an inherently corruptive influence on students and trainees, and threatens to impose a restrictive and biased world view upon them.”  Although Pharmascolds may have made the headlines for some stories, the article noted that, “there’s another competing narrative to consider.”

Those who wonder how academic orthodoxy is enforced in practice need look no further than the response to a recent lecture given at Case Western University by Dr. Tom Stossel, the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women’s Hospital, where he is also an attending physician. 

Stossel’s lecture, entitled, “A Hard Look at Physician-Industry Relationships AKA ‘Conflicts of Interest’” examined a multitude of research and discussion about the recent focus on industry-physician collaboration. 

At the beginning of his lecture, he noted how the Harvard Medical School 2009-2010 Report on Conflicts of Interest and Commitment clearly asserted that, “Interactions between academic and industry are crucial to science and to facilitating the translation of knowledge from the research bench to the patient bedside.” Then, his lecture went on to look at 1) the history of conflict of interest regulation, 2) weak & false evidence justifying regulation and high cost policies, and 3) why regulation of physician-industry relationships originates and persists.

Part of his presentation showed a chart examining “Articles per year concerning conflicts of interest,” which showed that since 1990, there has been a tremendous spike, something Stossel referred to as a “Conflict of Interest Mania.”

Stossel also presented a slide on a study he conducted of papers published in the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM) Concerning Physician-Industry Relationships.  His slide noted that of the articles examined between 1999 and 2009:

• 96% of articles showed physician-industry relationship risks, while only 4% showed relationship benefits
• Only 44% provided evidence or relationships risk, while 100% showed evidence of relationship benefits
• 76% drew inferences about patient outcomes based on relationship risks, however 0% drew evidence about relationship benefits
• Only 43% acknowledged an alternative viewpoint with respect to relationship risks, while 100% showed an alternative viewpoint on relationship benefits; and
• Only 3% critiqued alternative viewpoints of relationship risks, while 100% critiqued alternative viewpoint for relationship benefits.

The lecture then discussed how policies now mandate “massive confession and prophylactic rules,” which affect every aspect of medicine.  He noted:

• All corporate payments to physicians are disclosed
• Peer-to-peer speaking is prohibited (i.e. Harvard and Partners Healthcare)
• Physician-industry relationships preclude editorials, journal review articles, or service on guideline or FDA review panels
• No gifts, however trivial
• Heavily restricted payments for meals and travel
• Samples and detailing prohibited or limited
• And payments for value are eliminated or limited

Moving along, Stossel noted how the mania surrounding conflicts of interest use allegations to justify conflict of interest regulations.  These critics make arguments such as:

• Industry’s profits exceed value added
• Industry’s marketing is fundamentally deceptive
• Industry relationships degrade and bias research and cause physicians unwittingly to promote or prescribe unsafe and / or unnecessarily expensive products that harm patients; and
• Payments to physicians for time or work erode “professionalism” and public trust

Consequently, he then moved on to show how physician-industry collaboration has produced significant value, through longer life-expectancy, and better survival rates for severe and chronic disease such as cancers, HIV, and heart disease.

Nevertheless, Stossel showed a number of slides quoting famous academic researchers and leaders of medical institutions who ascribe to the belief that physician-industry collaboration is harmful for the reasons noted above.  Moreover, Stossel specifically addressed one study in particular that critics of industry point to, the Wazana study, and recognized that despite the study’s claims about harm to patients, “no study analyzed by Wazana used patient outcome measures.”

However, Stossel recognized how such viewpoints are misguided considering:

• There has been no decrease in the esteem with which physicians are held by the public in the past 20 years
• 90% of citizens surveyed believe physicians and industry should work together; and
• Most patients in cancer trials have no concern about their physicians commercial relationships

Additionally, Stossel’s lecture explained how conflict of interest rules and regulations are a “purposeless resource diversion.” He noted how the “redundant industry, health center, state and impending federal (“sunshine act”) payment disclosure registries are:

• Expensive
• Inaccurate
• Almost useless; and
• Abusive

Forbes Article

Interestingly, the author noted that Stossel’s lecture “was well-attended.”  However, the real news he noted, “was the three sentence email received by members of the Case Western faculty prior to Stossel’s lecture — a nastygram sent by a colleague at the neighboring Cleveland Clinic.

Subject line: “Re: Medicine Grand Rounds — Tuesday September 13th” (i.e. Stossel’s talk).  Body of the email (in full): 

”This guy is an embarrassment to the medical profession.  Can’t believe you would have him provide Grand Rounds.  Your trainees deserve better.”

The Forbes article noted how this kind of email, written by industry’s leading critic Steve Nissen, attempted to discredit Dr. Stossel. 

The author noted that Nissen used an “ad hominem attack (baseless) against Stossel merely because he is an industry critic.  The article noted how “the critique was especially striking given that Stossel’s academic credentials are far more robust than most (if not all) of the Pharmascolds, including in particular a number of medical journal editors who have little original academic record to speak of, and have achieved almost all their considerable fame and now academic prominence by climbing on board the conflict-of-interest bandwagon.”

Moreover, the article recognized that, “the relatively small fraction of Stossel’s academic publications that do speak to conflict-of-issue issues strike me as all the more remarkable given the obvious comfort level that many medical journals (and their peer reviewers) have for confirmatory papers in this space, and their natural reluctance to publish (and arguably validate) disfavored arguments such as Stossel’s.”

Accordingly, the author recognized that with regards to Nissen, “the medical profession deserves better.”  

Rather than challenging the arguments of Dr. Stossel, Dr. Nissen used a ad hominem slight of hand to discredit those he disagrees with.  In the end thanks to the email the lectures were packed and students were able to learn the value of the relationships with industry.

SACME Harrison Survey of Academic CME 2010

 
Since 1981, the Society for Academic CME (SACME) Research Committee has surveyed continuing medical education (CME) units at medical schools in the U.S. and Canada. Beginning in 2008, the Association of American Medical Colleges (AAMC) partnered with SACME to prepare this report. The Biennial Survey of Society members includes questions about the organization of the CME unit, its relationship to the larger organization in which it resides, the ‘product’ of the CME unit (courses and other activities and interventions), its funding base, research and innovation, and other items related to the operation of the CME unit.

The survey is electronically distributed to all U.S. and Canadian medical schools, teaching hospitals in the U.S., and clinical academic societies who are members of the AAMC’s Council of Academic Societies (CAS). The most recent survey results from 2010 were recently released and are summarized below.

Conferences and Courses

On average, the survey showed a drop in CME units over the past three years. Specifically:

• In 2010, over 130 courses on a yearly basis vs. 147 in 2008
• In 2010, approximately 1,363 credits vs. over 3,000 credits in 2008
• In 2010, attendance of 7,500 physicians vs. 9,000 physicians in 2008
• In 2010, attendance of 4,000 non-physicians vs. 4,600 non-physician participants in 2008

Regularly Scheduled Conferences, Series, or Rounds (RSS)

There was also a drop in CME units who provide credit for regularly scheduled conferences, series. Specifically:

• In 2010, 58 regularly scheduled series vs. 83 in 2008
• In 2010, 1,600 credits vs. 2,274 in 2008

In addition, the numbers of asynchronous audio, video, and online courses also decreased. Specifically:

• In 2010, 52 courses used video, audio vs. 170 in 2008
• In 2010, over 230 credits were given vs. 266 in 2008
• In 2010, these attracted  4,000 documented physician users vs. 6,895 in 2008

Commercial Support of CME

For 2009, CME units were asked report the revenue they generated from a variety of previously-selected sources. In total, representing the responses of a large percentage of the academic enterprise devoted to CME in North America, over 100 CME units reported $342M in annual revenues, of which they spend slightly over $370M, for a net overall loss. Of their revenues:

• 37% derived from registration fees (markedly up in two years from 29%);
• 28% from commercial support (markedly down from 2008 at 54%); and
• Advertising and exhibits at 17% (nearly tripled from 2008 when it was 5%).
• Institutional and other funding streams were essentially unchanged.

By this report, there has been a sizable decrease in the proportion of commercial support in a two-year period. US schools reported 34% direct commercial support, appreciably decreased from previous surveys, which indicated more than half of revenues derived from this source.

Teaching hospital revenue streams (when compared to US medical schools) reflect a similar percentage of income:

• Commercial support (31%)
• Advertising and exhibits (12%); and
• Registration fees (33%).

Academic society’s revenue streams garnered:

• Much less support from commercial entities (11%)
• Registration fees (18%) and
• A significantly larger percentage from advertising and exhibits (48%).

With respect to the number of CME activities which received commercial support:

• In 2010, 68 activities received commercial support vs. 145 in 2008
• In 2010, 26 of these activities would have been solely supported vs. 48
• In 2010, 42 activities would not have been offered without commercial support vs. almost all 48 programs in 2008.

Discussion

Interestingly, the report showed that 98% of respondents had policies regarding commercial conflicts of interest (COI). This number is important for two reasons. First, such a high percentage of COI policies may account for the decrease in commercial funding, although the numbers are roughly the same since 2008. Nevertheless, there is a good chance that increased enforcement, oversight, or changes to those policies in light of recent media attention could have resulted in policies banning commercial support of CME or creating policies that make commercial support unappealing to sponsors and frowned upon my institutions.

Second, this high number of policies should be a positive reason why academic medical centers should be collaborating with commercial entities to create CME. With policies in place, potential COIs can be managed, bias can be eliminated, and the quality of programs can be significantly increased. In fact, over 85% of the 88 US schools who responded reported a moderate or extensive change in their operation of CME units by adopting the new ACCME criteria. This change is important to recognize because it shows that medical schools are implementing policies that align with ACCME criteria, which ensure adequate management of commercial support and objectivity in program content.

Conclusion

Ultimately, the apparent decrease in the average number of standard courses, accredited CME activities such as rounds, and regularly scheduled series is concerning. This decline is almost surely related to the decline in commercial support of CME activities at medical schools and centers. 

Once commercial support is reduced, schools and centers can no longer support the resources or staff necessary to offer adequate or similar programs to faculty, staff, and surrounding community health care professionals.

Such a finding that commercial support is becoming harder and harder to get is problematic considering almost every school or medical center has a COI policy in place, suggesting that many of these institutions may need to revisit such policies to make sure they are not too burdensome that they are driving away commercial support.

In the end, medical schools and centers should be working with commercial entities to provide objective CME that will bring the latest advances, newest information, and clinical data to physicians. Much of the concerns that medical schools or centers have about the role of commercial support can be adequately addressed in institutional COI policies, but these regulations must carefully balance the role of commercial support so as not to deter academic-industry collaboration.

If commercial support continues to decline, and the number and kind of CME courses continues to decline, America’s leading medical schools and centers will face significant problems training and educating our health care professionals.

Federal Budget Cuts and Teaching Hospitals

 
With the announcement of a deal between the White House and Congress over raising the debt limit, there is a underling debate that eventually will effect medical schools and education of future physicians.

Within the debate about reducing deficits and increasing the debt ceiling, one troubling idea that Congress has suggested is cutting more than $60 billion in Medicare payments for graduate medical education at our nation’s teaching hospitals – which could undermine the new health insurance law, gravely affect patient care, and threaten our economic recovery.

The cuts would reduce the Medicare subsidy for training doctors and for providing intensive medical services like trauma centers and burn units and sophisticated equipment that the teaching hospitals offer. The plan would apply to teaching hospitals nationwide but would have its most profound impact in cities like New York and Boston, where medical schools and their affiliated hospitals have a significant presence.

Federal financial support for medical education began with the G.I. Bill of Rights after World War II, and became part of Medicare after it was established in 1965, according to a study in the Journal of General Internal Medicine. It has survived, with modifications and many attempts to curtail it over the years.

Critics of the Medicare payment say it has become a hidden subsidy for hospitals’ operating costs. But the administrators of New York’s teaching hospitals say they operate on very thin margins because they serve large proportions of patients who are receiving government insurance for the poor and the elderly, and because they provide some of the most sophisticated — and expensive — medical treatment in the country. Either way, the hospitals have come to depend on the money.

Cutting payments for graduate medical education to teaching hospitals would have astronomically negative impacts on patient care in America, especially given the fact that an additional 32 million Americans will gain health coverage under the Affordable Care Act. Reducing payments will only further exacerbate the physician shortage America already faces. By 2020 the nation is expected to face a shortage of 45,000 primary care physicians and 46,000 surgeons and medical specialists, according to the Association of American Medical Colleges —a stunning shortage of 91,000 doctors.

As Rep. Joseph Crowley (D-N.Y.), who sits on the House Ways and Means Committee, explained in a recent article in POLITICO, if Congress were to cut Medicare payments to graduate medical education, it would be extremely problematic and harmful to patients and Americans for a number of reasons.

As Crowley pointed out, “teaching hospitals educate the next generation of physicians—who are clearly essential for our future,” and “the importance of academic medical centers and teaching hospitals goes far beyond delivering care” because “they serve as economic anchors in their communities.”

In his district, for example, the Bronx’s Montefiore Medical Center could lose more than $100 million annually from the proposed cuts—a staggering loss that would severely harm their local economy. There is no question that this is real money with real consequences: More than 70,000 well-paying jobs are at risk nationwide. In fact, according to the New York Times, New York State’s prestigious teaching hospitals could lose more than $1 billion a year.

Montefiore Medical Center in the Bronx, Mount Sinai Medical Center and New York-Presbyterian Hospital in Manhattan would be the hardest hit in the nation by Medicare cuts, followed by U.P.M.C.-Presbyterian in Pittsburgh, the Hospital of the University of Pennsylvania in Philadelphia and Massachusetts General Hospital.

“The impact would be devastating to a place like Montefiore and to the borough of the Bronx and the City of New York,” Dr. Steven M. Safyer, president and chief executive of the medical center, said Monday. “It would be incomprehensible what it would lead to. We’re the main employer in the Bronx, with 18,000 employees. It would lead to loss of jobs, curtailing the pipeline of the doctors of tomorrow, exacerbating the health needs of this very challenged community, the Bronx.”

Though the final numbers may well change, under the worst-case situation New York hospitals estimate they would lose $1.25 billion, or 57 percent, of the $2.19 billion a year they currently receive in Medicare subsides for medical education, according to the Greater New York Hospital Association, a powerful lobbying group. It expects the cut would begin in 2015. Nationwide, hospitals would lose $5.8 billion of their current $10.9 billion in payments, or 53 percent, according to the group.

A more modest deficit-reduction package now being discussed, however, would cut only $1.4 billion nationwide over 10 years.

If the larger proposal is passed, Montefiore will lose $1 billion over 10 years. The hospital trains 1,200 residents at any one time, turning out 350 to 400 doctors a year, Dr. Safyer said. A vast majority of its patients — 80 percent — are on either Medicare or Medicaid.

The Simpson-Bowles Commission, which advised Mr. Obama on debt and deficit reduction, called in December for reducing “excess” payments to hospitals for medical education. The commission said the payments could be brought in line with the costs of medical education by limiting the direct subsidy to 120 percent of the national average salary paid to residents. A second, indirect subsidy, which pays for intensive services and advanced equipment that teaching hospitals typically provide, should also be reduced, the commission said.

Gail R. Wilensky, a former senior health and welfare adviser to the first President George Bush, said numerous studies by the Congressional Budget Office and others have found that the indirect subsidy is overfunded by “several percentage points higher than can be justified empirically.”

Dr. Wilensky said it might make more sense for subsidies for training medical residents in various specialties to go directly to the residents, who are working for low wages and essentially supporting the hospitals with their cheap labor, rather than to the institutions.

But hospital officials said the payment covered not only residents’ salaries and benefits, but also the supervising physicians’ salaries and benefits, and overhead like classroom space.

The average resident salary in the Northeast was $54,093 in 2009, the most recent year for which figures are available. In New York, with fringe benefits, supervisors’ salaries and overhead, the total cost of training came to $128,400, according to the hospital association. On average, Medicare subsidized 39 percent of that amount, or $49,581, roughly proportional to the percentage of inpatient treatment that was covered by Medicare.

Senator Charles E. Schumer, Democrat of New York, who has been involved in the negotiations, said he was doing everything he could to keep the education payments.

“This to me is one of the lifebloods of New York,” Mr. Schumer said. “One of the best things New York does for America is train high-quality physicians who then sally forth around the country and provide great medical care for the rest of their lives.”

These cuts potentially compound two other issues according to Henry Black MD, ACRE leader and NYU faculty “one issue is the limitation on the number of hours that a resident is permitted to be on duty. As a result, teaching hospitals have already had to increase the number of trainees or reduce the time spent on nonpatient care activities.

The second is the unanimous concern that the United States is facing a serious shortage of primary-care physicians and specialists, who will be necessary to care for our aging population.”

Discussion

Far from being a luxury, Crowely recognized that “teaching hospitals depend on this funding to fulfill their mission.” Teaching hospitals confront significant additional costs as a result of training physicians, which includes direct costs like salaries and benefits for residents and their faculty, as well as overhead and clerical costs.

There are also the indirect costs that come with being on the front lines in training doctors. These hospitals usually treat more complex cases, and need medical residents to order more diagnostic tests as part of the learning process.

Crowley further recognized that America’s “teaching hospitals help develop the next generation of physicians, and they cannot be asked to skimp on the advanced teaching services and equipment that are part of this responsibility.”

Dating to the 1960s, the subsidy has helped make New York State the world capital of medical education, training about 16,000 doctors a year, or 14.5 percent of the nation’s total, more than any other state.  In New York particularly, where one out of every six doctors in the country is trained, teaching hospitals have welcomed their role. But Crowley asserted, “they cannot do it alone.”

Congress has long recognized the additional costs associated with training our future doctors. The federal government has supported its share of the costs through Medicare’s graduate medical education payments. Hospitals are already stretching their Medicare reimbursements as much as possible, and cuts to these payments would be a further strain on these critical institutions.

As a result, Crowley urged the President not to cut Medicare payments for graduate medical education and to follow his own words, by not turning our backs on critical investments in our future or at the expense of badly needed economic growth. He asserted that, “Medicare cuts to medical education are clearly not the answer, and Congress needs to look beyond the temptation to just cut and see the bigger harm to our country.

Representative Carolyn B. Maloney, a Democrat whose district includes parts of Manhattan and Queens, said in a statement that cutting money for medical education would be a mistake. Ten teaching hospitals on the East Side of Manhattan rely on the subsidy and “train doctors who will, once trained, provide care for Americans across the country,” Ms. Maloney said.

If Medicare payments are cut for graduate medical education at teaching hospitals and academic medical centers, this will have significant financial impact on other areas of these institutions, particularly continuing medical education (CME) departments.  Resources and staff in CME departments are already scarce, and sometimes nonexistent. 

Henry Black, MD sums it up nicely “How can we do all of these things — reduce the number of residents whom teaching hospitals train (an inevitable consequence of reducing the Medicare “subsidy”) at the same time that we limit the number of hours those residents are allowed to work — yet still increase the number of physicians we produce? Do the math: this simply doesn’t compute.”

If cuts occur, the resources of CME departments may have to be used and altered to account for such cuts, and this will make it harder for institutions to provide meaningful CME to their staff and health professionals as well. If the faculty to who are educating these graduate medical students and residents cannot get meaningful CME from their own institutions, it is difficult to see how will they be able to ensure that our next generation of doctors is the most educated and up-to-date?

Time to Blow the Whistle on Proponents of Restrictive Conflict of Interest Rules in Medicine

 
Over the past several years, academic medical centers, professional medical organizations, industry trade groups, and federal agencies have transformed the way their institutions handle “conflicts of interest.” 

Medical schools such as Harvard, Michigan, and Yale, hospitals such as Partners, and the National Institutes of Health (NIH), have all proposed or changed their policies regarding what outside financial activities and interest’s faculty and staff can have.  Industry has also taken significant steps to address potential conflicts of interest in medicine and research through the PhRMA and AdvaMed Code of Ethics, and the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.

In addition to these changes, the news media have fueled controversy and concern about physician-industry relationships and research, mostly stemming from leaked documents from product liability, plaintiff litigation.

This “un-perfect storm” has created an environment in the medical community that stigmatizes working with industry.  Instead of being proud of the collaboration and innovation that physician-academia-industry relationships provide, more health care practitioners are seeing their names published in local media. And for what?  Educating other doctors and providing services that will progress medicine.

As David William Rattner, MD recently noted, “it’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry.”  His commentary was drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting.

Dr. Rattner, chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, asserted that, “the insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care.”

Conflicts of Interest

The Institute of Medicine (IOM) defines a professional conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal.”

As Dr. Rattner pointed out, many doctors find themselves conflicted professionally when they participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. He noted how in these situations, physicians are asked to use their judgment and place the interest of what they are trying to do above their own personal interests. “Physicians are never asked to disclose these other kinds of conflicts, and it’s extremely rare that they are asked to excuse themselves from the process.”

He explained that, “one of the greatest conflicts of interest physicians have is the way in which they are reimbursed – whether by capitation or fee for service.”  What is in a physician’s personal best interest may not line up with what is best for their patients, but this is not something a physician discloses.

“So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively?”

The Impact of COI Rules

Dr. Rattner noted that he has been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years and is also a former president of SAGES.  He asserted that if the conflict-of-interest rules currently being forced on physicians had existed in the 1990s or the early part of the past decade, SAGES would not be what it is today.

When he joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. The leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass.

He note that, to the best of his knowledge, “no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that patients will benefit.”

Similarly, Dr. Rattner recognized that the most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but he asserted that, “the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques.”

Accordingly, Dr. Rattner noted that, “if future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.”

With respect to research, Dr. Rattner asserted that, “the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous.” While companies want to be successful, “doing so at the expense of patient health and safety would simply be bad business.”

He noted that, “the financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it.” Additionally, Dr. Rattner explained how drug and device companies anticipate the rigors of the Food and Drug Administration (FDA) review that is required before their products are brought to market and if fraud is discovered or a patient harmed, the consequences can put the company out of business.

Conclusion

The benefits of physician-industry collaboration are remarkable.  As Dr. Rattner pointed out, “investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly.” And what the public must realize is that the research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors.

Consequently, “before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities.”  The bottom line “is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.”

Accordingly, Dr. Rattner asserted that, “the onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.”

There is no question that “financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.”

If we continue down the path of overly restrictive conflict-of-interest policies, patients will lose access to life saving medicines and treatments and future generations of physicians will not benefit from the innovations and advances physician-industry relationships provide. As a result, institutions, academic medical centers, professional societies, and federal agencies need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.

Harvard Physicians Sanctioned for Failing to File Proper Disclosure

 
Last week, Massachusetts General Hospital and Harvard Medical School sanctioned renowned child psychiatrist Dr. Joseph Biederman and two colleagues after finding they violated conflict of interest rules.  The sanctions came at the end of a three year investigation, according to an article in the Boston Globe.  

In a letter to coworkers, Biederman and Drs. Thomas Spencer and Timothy Wilens said the hospital and medical school determined they had violated certain requirements of the institutions policies. They did not specify the nature of the violations.

Harvard revised its conflicts of interest policies last year.

In a statement from Massachusetts General Hospital said that a committee at from the hospital had been looking into conflict-of-interest questions involving the three MGH child psychiatrists note above and completed its review.  The statement said that, “appropriate remedial actions have been taken by the hospital to address specific issues.”

Background

According to the Globe, Biederman is the country’s most prominent advocate of diagnosing bipolar disorder in children, even in those under age 6, and using antipsychotic drugs to treat many of them. He became one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine.  Some say that his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

In 2008, Senator Charles Grassley (R-IA) accused the three doctors of accepting millions of dollars in consulting fees from drug makers from 2000 to 2007, and of failing for years to report much of the income to university officials.

Congressional investigators led by Grassley accused Biederman, Spencer, and Wilens of failing to disclose more than $1 million each in payments they received from industry over the eight years. In addition, documents in a lawsuit portrayed Biederman as courting drug company money by promising that his work at Mass. General would help promote the use of antipsychotic drugs for youngsters - a characterization Biederman has said is untrue.

During a speech on the Senate Floor, Senator Grassley asserted that the conflict of interest forms he received from the university for these three doctors were a “mess” and that his “staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

Physicians are required to disclose payments from pharmaceutical and medical device companies so that hospital and university officials can police potential conflicts of interest that may create bias in research or in the treatment of patients, or the appearance of bias.  Every hospital and medical school has a different conflict of interest or disclosure policy, and federal agencies have their own reporting requirements for research grants for the National Institutes of Health (NIH), and for serving on advisory committees at the Food and Drug Administration (FDA).

 

Medical journals also have disclosure policies, as do professional organizations and societies, but these policies vary as well.

The three psychiatrists apologized in their letter for the unfavorable attention that this matter has brought to these two institutions. They called their mistakes “honest ones but said they now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

Sanctions

The three doctors explained that the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer a delay of consideration for promotion or advancement.

Dr. Jerome Kassirer, a Tufts University School of Medicine professor and outspoken critic of close ties between the drug industry and physicians, called this punishment a “slap on the wrist.”  He pointed out that He pointed out that Biederman is already a full professor at Harvard Medical School, so it’s unclear how a delay in promotion or advancement would affect him. Dr. Kassirer also noted that Biederman severed his industry ties soon after Mass. General and Harvard began their separate but coordinated investigations.

However, Dr. Benjamin Liptzin, chairman of psychiatry at Baystate Medical Center in Springfield, said he believes the actions “send a serious message that the hospital and medical school take this seriously.’’

Doctors agreed that since the mid-2000s physicians, particularly psychiatrists, are more cautious about taking money from drug companies, and about disclosing the money they do earn. Responding in part to public distrust, hospitals and universities - including Mass. General and Harvard - have further limited how much money doctors can accept and are more stringently enforcing disclosure requirements.

Liptzin said that, during those years, it was common for companies to fund clinical trials of psychiatric drugs and then hire the physician investigator as a consultant to speak about the results across the country.  Now, he said, “far fewer doctors accept payments, and those that do are far more careful about disclosure. People understand that we need to be as objective as possible in advancing our knowledge.’’

Conclusion

Ultimately, while Harvard an Mass General have taken the necessary actions to address these events, media and the general public should not use this example to generalize about physician industry relationships or the collaboration that exists between doctors an companies.  As it is clearly stated in almost every story, Biederman is one of the leading experts in the world on psychiatric issues, and as such, his work and expertise is necessary to advance the field to improve patient outcomes and help teach other physicians.  While his mistakes and omissions for disclosure are important, the overwhelming majority of physicians who work and collaborate with industry accurately and adequately file disclosure forms with their institutions. 

Transparency is important for advancing science and medicine. However, when there is a rare failure in transparency, as in this case, it should not be an excuse for others to generalize about industry-physician relationships.  These partnerships are beneficial, and should be continued.    Once has to ask themselves what is the most valuable use of a researchers time, filling out disclosure paperwork or research and patient care.   It has not been proven how people can effectively do both at the exact same time, there has to be a sacrifice of one (patient care and research) to achieve the other (great disclosure paper work to their institutions).

As transparency comes to the forefront with the Sunshine act, these issues will eventually disappear or perhaps not as it may take a life of its own, as physicians will report to their institutions 1099 income and companies will be reporting all transfers of value, from transportation to meals.

The system is a mess and it is just going to get messier.

American Medical Student Association and Their Pharm Free Association with Naturopathy

 
Recently, the American Medical Students Association (AMSA) held their annual conference.  Interestingly, one of the participants of the conference provided an ongoing commentary of the events and happenings at this year’s conference.

 

Of particular interest, the commentator noted that AMSA sold the Association of Accredited Naturopathic Medical Colleges a booth at the 2011 convention.  As the author pointed out, AMSA will not take money from pharmaceutical companies, but they have no problem with taking money from “pseudoscience.”  Perhaps a conflict of interest?

 

Consequently, the author described how he went up to the booth to find out what

naturopathy is.  He was told that they are “primary care physicians” who treat the “whole patient in a holistic way.” In addition, one of the table reps told the author that naturopathy subscribes to the use of homeopathy, herbalism, acupuncture, therapeutic touch, and “all sorts of other nonsense.”  The author also pointed out that their “written materials were more straightforward about their quackishness.”  Ultimately, while AMSA “professes to support evidence-based medicine,” the author was disturbed by the fact that AMSA  would legitimize “quackery of this sort.”

 

What is problematic about AMSA’s approach of accepting alternative medicine and banning pharmaceutical support is that it creates an inherent bias among the organization.  This bias is detrimental to advancing medicine, science, and medical education, particularly because AMSA is a vocal voice in the medical community.  Such a revelation that AMSA is willing to accept money from “pseudoscience” instead of hard science, should cast many doubts on the positions that the organization maintains on various policies.  Calling for evidence-based practices, while accepting money from alternative medicine—hardly even close to evidence based—should also cast serious concerns about the Soros and Pew funded PharmFree Campaign started by AMSA in 2002.

PharmFree Campaign

The campaign was started for medical students to advocate for evidence-based, rather than marketing-based prescribing practices, the removal of conflicts of interest and global access to essential medicines. AMSA provides toolkits, talks and training institutes to help medical students advance these goals.

To advance these goals, AMSA released its first "PharmFree Scorecard" in 2007. This initial Scorecard graded medical schools on the presence or absence of a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with The Pew Prescription Project, an initiative of the Pew Health Group, to develop an updated Scorecard, which used a rigorous and transparent methodology to assess the content of policies at medical schools throughout the country. 

This framework was used again in the 2010 AMSA PharmFree Scorecard, published last month. The AMSA PharmFree Scorecard evaluated conflict-of-interest policies at 152 medical colleges and colleges of osteopathic medicine in the United States, with a focus on interaction between students or faculty and the pharmaceutical industry.

Using letter grades to assess schools’ performance in eleven potential areas of conflict, the Scorecard gives a comprehensive look at the current and changing landscape of conflict-of-interest policies across American medical education, as well as more in-depth assessment of individual policies that govern industry interaction. It also examined potential conflicts of interest created by industry marketing at the level of the individual physician and trainee. 

Method 

The PharmFree Scorecard methodology was developed jointly by AMSA and the Pew Prescription Project, an initiative of the Pew Health Group. Assessed domains are broadly consistent with those identified in recent literature – primarily Brennan et al. Health Industry Practices that Create Conflicts of Interest:  A Policy Proposal for Academic Medical Centers. These include policies related to acceptance of gifts and meals from industry; consulting relationships; speaking relationships; disclosure of financial conflicts; and pharmaceutical samples.

Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard, and then use a formula to derive a letter grade.   

2010 AMSA Scorecard

As of December 15, 2010, 140 of 152 medical institutions had participated in the Scorecard, a 92% participation rate, improved from 88% in 2009. Of 152 US medical schools:

-       19 receive As (13%)

-       60 Bs (39%)

-       24 Cs (16%)

-       18 Ds (12%), and 

-       26 schools (17%) receive a grade of F.

In 2010, over 50% of medical schools, now have grades of A or B (78 schools). This was a tremendous increase from 45 A and B schools (30%) in 2009 and shows a continued progression from 29 A and B schools in 2008. Additionally, 21 schools improved their scores to a C or above after submitting updated policies for review.

AMSA noted in response to this data that “Conflict of interest has clearly become a central issue in medical administration and education and more schools are recognizing the importance of thorough policies.” Specifically, AMSA recognized the University of South Dakota Sanford School of Medicine, Tufts University, and Des Moines College of Osteopathic Medicine for “submitting dramatically improved policies which increased their scores from Ds to As.”

The 2010 Scorecards also recognized 9 other schools that improved at least 2 letter grades: Wake Forest University, New York Medical College, Virginia Commonwealth University, University of Minnesota-Twin Cities, Temple University, Case Western Reserve University, University of Illinois, and University of New England College of Osteopathic Medicine.

The report also noted that medical schools in California, Pennsylvania, New York, Texas, Florida and Massachusetts continued to excel, with a majority of medical schools in each state earning strong grades on the Scorecard. In addition, between 2008 and 2010, the number of perfect scores increased in every domain graded by the Scorecard. 

For example, in 2010, three times as many schools received perfect scores for addressing industry support of scholarships, off-campus continuing medical education, purchasing, and gifts compared to 2008. Notably, the number of institutions with model curriculum on conflict of interest quadrupled between 2008 and 2010.

Nearly one-third of schools now teach medical students to understand institutional conflict of interest policies, to recognize how industry promotion and marketing can influence clinical judgment, and to consider the ethics around conflict of interest. The areas with fewest perfect scores were on-campus continuing medical education (CME) and the access of sales representatives.

Discussion

AMSA's national president, Dr. Brian Hurley, noted that “AMSA's Scorecard is meant to be not only a yardstick for measuring U.S. medical school conflict-of-interest policies, but also a guide for medical schools working toward adopting stronger and more practical policies.”

Robert Restuccia, executive director of The Prescription Project asserted that "The schools that earned 'A' and 'B' scores are to be commended for setting a high bar and aggressively moving forward to ensure medical education, training and patient care is free of commercial bias.”

Heather Pierce, JD, senior director of science policy and regulatory counsel at the Association of American Medical Colleges (AAMC) asserted that “The positive changes reflected in this assessment highlight the active engagement of the academic medical community in addressing industry interactions, both through policies and the education of its faculty and students.”

However, the Association of Clinical Researchers and Educators (ACRE), which supports relationships with drug companies, called AMSA misguided for its lack of understanding about how such partnerships can benefit students and patients. ACRE noted in its statement that “AMSA has devoted their time and resources rating medical schools on biased, meaningless subjects which reflect little on their actual education."

Additionally, one physician stated that he was proud that the academic medical center he worked at, Western University, received an F from AMSA Scorecard. Specifically, Jeff Unger, MD, associate director of metabolic studies at Catalina Research Institute in Chino, asserted that the AMSA Scorecard and Pew Prescription Project are an “obscure group of liberals who have nothing better to do than criticize those of us in the private sector trying to improve the lives of our patients.”

Dr. Unger’s editorial offered AMSA and Pew a historical lesson about the pharmaceutical industry in hopes that they might spend their time on something better than “releasing results of such useless surveys.” He pointed out how the discovery of insulin in 1922, which was mass-produced by pharmaceutical companies such as Eli Lilly, changed the landscape of medical science and proved that chronic disease could be treated effectively with a specific medication. Since 1945, the pharmaceutical companies have spent billions of dollars developing new classes of drugs to treat diabetes.

As a result, he asserted that “None of these accomplishments would be possible without pharmaceutical company innovation, education and support.” Morever, Dr. Unger recognized that “pharmaceutical companies are not the enemy, and that all increasing government interference with companies has done is drive up research and development costs.

Dr. Unger further acknowledged that the role of industry is important because pharmaceutical companies “provide educational opportunities to physicians, physician assistants, nurses, nurse practitioners and certified diabetic educators about disease state awareness and treatment guidelines.” As he noted, “these programs are tightly regulated by the FDA and providers who attend these programs overwhelmingly approve of the educational format and the professionalism of the presentations.” 

With respect to other policies graded by the scorecard, Dr. Unger explained that “Patients should thank physicians who see pharma reps because they enable physicians to provide patients free samples for medications they are unable to afford because their insurance will not cover them. These samples are extremely important for diabetes patients because the medications used to manage diabetes “are often safer and more effective than those available on standard third-payer formularies.”

He also pointed out that with the assistance of pharmaceutical representatives, physicians can help patients in applying for company programs that help patients pay for drugs they cannot afford.

One important observation about the important role of industry that Dr. Unger offered was a recent experience he had while lecturing. He explained that the speakers “before him, who were from Ivy League schools that did not allow visits from pharmaceutical reps, gave the audience incorrect information regarding a particular diabetes drug.” As a result, he had to “correct the audience by explaining the latest FDA approvals regarding the particular drug, which a pharmaceutical representative had explained to him three days prior to this national meeting.” 

Conclusion

Ultimately, the impact of the AMSA Scorecard remains questionable, especially given the new revelation that AMSA accepts money from alternative medicine, but not industry. Where does the actual quality of teaching or patient care get ranked in their system? Does ‘improved’ score equate to anything other than less media attention of non-issue? While it is important that academic medical centers continue to implement policies for interacting with industry, until evidence shows that less industry-academia collaboration improves patient care and outcomes, these Scorecards will continue to hinder collaboration and innovation, and AMSA and the Pews will continue to be “thorns in the side of medical progress.”

As Dr. Unger recognized, academic medical centers “should continue to welcome pharmaceutical reps and pharma companies onto the campus and their medical students should learn the value that these liaisons share in changing the lives of individuals afflicted with acute and chronic diseases.” Moving forward, Dr. Unger noted that instead of listening to AMSA and Pew, “the voices of patients who suffer from chronic diseases are the only ones that should count in the finally tally.” 

University Medical Centers COI Policies and Innovation: Talk the Talk but Not Walk The Walk

 
A small, but vocal group of critics has attempted to dismantle and stigmatize physician-industry relationships for a number of years.  In fact, many of these individuals make their careers writing “scholarly” articles about the potential conflicts of interest (COI) in such relationships and professing themselves experts in this area of ethics in medicine. 

Despite critics belief that industry-physician collaboration may create bias, the “overwhelming evidence that relationships between universities, physicians and the medical products industry benefit patients explains the ubiquitous calls to encourage such relationships.”  Unfortunately however, “accumulating ‘conflict of interest’ regulations in academic health centers, government and industry have had the opposite effect,” scaring away such collaboration and in doing so, stifling innovation.

Consequently, as Lance K. Stell, PhD, professor of philosophy at Davidson College, and Thomas P. Stossel, professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s  Hospital, pointed out in a recent commentary in Nature Medicine, “justifications underlying the regulations lack quantitative rigor, and the rules they enforce impose costly bureaucratic requirements of dubious benefit.”  Moreover, evidence shows that these COI regulations “have diminished the collaborations deemed beneficial to health enhancement.”

As a result, Drs. Stell and Stossel noted that, “every policy governing the relationships between academic medical centers and the medical products industry ‘talks the talk’, forthrightly affirming that these relationships are essential for drug and device innovation.”  However, they recognize that, “product innovation is in serious trouble when the same academic institutions profess to defend industry-physician collaboration while apologetically genuflecting to a COI regulation movement, the effect of which has been to suppress such collaborations.”

History of COI Movement

What is problematic about the current physician-industry collaboration atmosphere we live in today, according to the authors, is that we ignored warnings from nearly twenty years ago about “a new McCarthyism” in relation to COI policy.  Yet, instead of listening to this warning from Kenneth Rothman and rising to fight it, “we invited onto our campuses moralizing avatars dedicated to purging them of corruption, the seeds of which were supposedly sown by industry’s insidious exploitation of the freedom of association and of speech.”

Accordingly, “their white-glove inspections found traces of conflict in doctor’s pockets, on their desks, in their sample cabinets, in their food, in the programs of their professional meetings—everywhere.”  And instead “of critically evaluating and rebutting their allegations, chagrined, doctors acquiesced to round after round of prophylactic COI regulations, each iteration more intrusive than the last, delineating what must not be said, what types of association must not occur and what hard-earned rewards for excellence cannot be accepted by researchers and educators in our most prestigious halls of medical learning.”

Even more troublesome is that doctors are “still apologizing for these relationships,” when “the vast majority of these relationships have been free of corruption and, more importantly, have produced value for patients.”  Drs. Stell and Stossel noted that without doctors working with industry to translate their ideas into useful products, today, Americans would not have a vaccine to prevent hepatitis B, a major cause of cancer worldwide, and percutaneous catheters, which enable physicians to gain access to diverse organs for diagnostic and therapeutic procedures with great speed and minimal morbidity.

Where is the Evidence?

Drs. Stell and Stossel assert that, “insinuations of corruption by those who call for increased oversight and regulation of the interaction between academia and industry require quantitative evidence—for a start, providing a denominator as well as a numerator.”

While many critics can easily compose the numerator by mentioning “the same cases alleging corruption due to industry influence, many laced with hindsight wisdom, dredged up repeatedly and assembled into a narrative framework,” a denominator is almost always missing.  In fact, “the storytelling suffers from serious ‘denominator neglect’—the non-nefarious, noncorrupt, beneficial collaborations, over decades that dwarf the comparatively few cases that populate the numerator.”

As the authors point out, “when attending to the numerator, the misconduct rate is negligible. The numerator of supposedly substantive adverse outcomes due to industry relationships (excluding relationship disclosure lapses discussed below) barely adds up to two digits. Surveys reporting that over 90% of physicians have some type of financial interaction with industry, with 18% of them engaged in consulting arrangements, indicate that the denominator is orders of magnitude greater.”

Moreover, Drs. Stell and Stossel assert that, “the laundry list of adverse consequences of commercial relationships consistently invoked by COI policy framers— degraded research, neglect of teaching commitments, excessive secrecy, loss of public trust—has not materialized.” In addition, they recognized that, “speculation that commercial support of education inflicts undue bias, leading some universities to reject such support, is belied by extensive surveys reporting little impression of such bias.”

Another problem with the COI movement is their “jaundiced eye on failures to disclose payments from industry.” Critics “put stock in the marketing of a need for greater transparency—‘sunshine is the best disinfectant’.  However, this seemingly plausible mission is not so straightforward; its outcome measures are not defined, nor is its price considered.”

This presents a problem for physician-industry collaboration because the ‘sunshine’ afforded to the COI movement—now federally mandated as part of the Patient Protection and Affordable Care Act—will have a substantial impact on innovation.  While this expensive effort is intended to help the public to make informed judgments about whether their healthcare providers have been compromised, are biased or likely to be disloyal, “the data cannot reliably support such inferences.”

The reality is this data will not show the public what innovation is.  It will not explain to Americans that, “innovation is not academic research” and that, “academic institutions, especially elite ones, are incompatible with the mass-production and quality-control requirements of product development.”  Nevertheless, what this data should show the public is that “academia and industry have much to offer one another—if given the chance.”

And what Americans must realize is that this chance for academia and industry to collaborate and innovate, “requires a lot of trial and error to accommodate the unpredictability of biology and adaptation to serendipity associated with innovation.”  As a result, “requiring minute oversight and contractual specification of every interaction and staples of COI regulations are inimical to such flexibility.”

Innovation

Outside of collaboration, Drs. Stell and Stossel also emphasized that clinicians can only help patients if they know about innovative products.  However, the COI movement derides “industry marketing as qualitatively different from and morally inferior to academic education, which stigmatizes “practically useful information (and academic health centers market their services aggressively with far less regulation than industry).” “Worse, banning such marketing from campuses drives a care-impairing wedge between producers of drugs and devices and prescribing physicians.”

“The COI movement insinuates that industry cares only about returns on investments and nothing about the appropriate use of their products, a charge not only disrespectful but wrong. The COI movement perpetuates the prejudice that the medical products and academic medical industries inhabit separate moral universes: the former unprincipled and greedy, the latter altruistic and dedicated solely to science and service. The evidence is to the contrary: research misconduct has been more common in academic settings where workers are subject to far less oversight than in the medical products industry.”

Accordingly, Drs. Stell and Stossel assert that, “demanding regulation of COI represents a pejorative, framing bias. No party to any relationship wears the same hat at the same time and in the same way; no relationship aligns hat-wearing incentives perfectly. Physicians wear many hats, and industry workers do, too. Myriad descriptions characterize the complex, nuanced relationships between academic physicians and workers in the medical products industry. To impress onto this complexity and, by fiat, the taint of ethical toxicity requires strong justification.”

However, the COI movement has no strong justification.  Instead, they stamp all physician-industry relationships with “arbitrary bias, insinuating that physicians’ relationships with industry need toxicity management—eliminate, reduce, minimize or disclose, rather than proliferate, increase and maximize.”  Drs. Stell and Stossel “challenge the linguistic legerdemain that substitutes ethically suspect for mutually beneficial.”

Discussion

The “poisonous language” from the COI movement “has promoted damaging policies in academic health centers in some states and in the federal government. The damage is not merely rhetorical. It has discouraged academic-industry collaboration because both parties fear media opprobrium. Worse, burdensome compliance requirements burn precious resources that would better go to collaboration, research and education.”  Additionally, industry itself is also facing barriers to collaboration “thanks to the exploitation of COI rhetoric by prosecutors in league with whistleblowers, maladaptive US Food and Drug Administration (FDA) law and draconian penalties (i.e. debarment).

Drs. Stell and Stossel note that, “patients desperate for new and better treatments should be appalled—we all should be appalled.” They noted that, “abandoning this desultory course requires that our academic leaders return to walking the walk.

Rather than shrinking before poorly justified, slogan-ridden allegations of critics, sensation-seeking media and demagogue politicians, they should subject them to the same rigorous analysis they demand from their scientific endeavors.” This analysis “will steer them to recommitting their institutions to collaboration and cooperation with their industry partners.”

Ultimately, such changes are necessary because Americans expect “excellence in research, education, and patient care,” and physicians “should pursue [these goals] with no apologies.”

University of Florida Begins New Conflict of Interest Policy

 
The University of Florida (UF) recently began implementing a new Conflict of Interest Program to address physician-industry interactions. The conflict of interest (COI) Program is focused on structuring appropriate, principled, transparent relationships with the university’s “valued Industry collaborators.”

According to the policy, industry “relationships are critical to the success of the University’s effort to teach medical students, train residents and fellows, and to provide the best care for our patients.”

However, the University of Florida recognized the changing direction of academic medical centers across the country that are introducing specific measures to maintain the public’s trust in academic medicine. Many of these policies have been enacted or changed largely because of extensive media coverage and intensifying government scrutiny about physician-industry collaboration.

Accordingly, the University of Florida introduced its new Conflict of Interest policy, and recognized that the determination that an individual has a conflict of interest “is a judgment about the situation and not about the professional who happens to be in that situation.”

The policy applies to a broad array of individuals employed by UF, including Faculty, Residents, Fellows, AP, and TEAMS, USPS & OPS (College of Medicine or “COM”).

Under the policy, “Industry” includes, but is not limited to, pharmaceutical, medical device, equipment, biotechnology, service, software, supplies, biomedical investment, and for profit educational companies and foundations sponsored by companies such as drug and device companies

Gifts and Food

• The policy prohibits accepting gifts of any kind and does not permit industry-purchased food at the College of Medicine.

Samples

• Generally, the policy prohibits samples, but UF faculty may petition the University of Florida Physicians Clinical Safety Committee for a waiver, and demonstrate clear and compelling benefit to patients in need and must provide safeguards for appropriate distribution and control.

Teaching Materials

• Generally not permitted to directly accept books, instruments, equipment, or teaching aids from Industry
• Want to encourage Industry and faculty to use the UF Foundation, which is designed to accept grants from Industry
• Dean’s Office will have oversight and audit function
• Materials/equipment may be donated to Foundation if properly transferred via a written agreement

CME and Non-CME

• If CME, must comport to ACCME standards and be processed through the CME office
• Non-CME educational activities are monitored, evaluated and subject to full disclosure

On-Site Training

• Industry may provide on‐site training with preapproval from the COM’s CME office or the Industry Academic Relations Committee if non-CME. Industry may also receive on-site training from COM personnel in the safe and proper use of certain medical devices and/or equipment.

Off-Site Events

• UF faculty may participate in or attend Industry-sponsored conferences and meetings and/or conferences and meetings of tax-exempt organizations funded or sponsored by more than one entity, which may include Industry under certain circumstances.
• Food/ beverages made available to the entire group are allowed. However, some companies report the provision of food/beverages and your name may appear in an Industry database.
• Travel expenses may not be paid by Industry unless you are speaking/presenting based on a written agreement.

Speaker’s Bureaus

UF’s College of Medicine defines a “speakers bureau” as any engagement in which you are speaking on behalf of Industry, where the content of the talk is not completely original to you; or the talk is subject to Industry approval; or the attendees of the event are selected by Industry or provided a gift or stipend to attend.

• Speakers Bureau activities are prohibited.
• Violations of this prohibition against Speakers Bureau activities will result in disciplinary action.
• As of January 1, 2011, faculty should not have any active Speakers Bureau relationships with Industry.

Ghostwriting

• The professional presentations, books, articles, reports, or other materials, oral or written, of COM personnel must have appropriate authorship attribution.
• Collaboration with Industry during any phase of manuscript preparation should be appropriately disclosed.

Scholarships/Fellowships

• Cannot be accepted directly from Industry
• However, Scholarship and fellowship funds may be provided to the Foundation for education, travel to educational programs, and for other educational purposes.

Disclosure

All faculty and members that fall under this policy must disclose outside activities and financial interests, which is to be reviewed by the department chair or immediate supervisor and forwarded as necessary for authorization. The form must be completed and filed prior to such time as the outside activity or financial interest begins and at the beginning of each fiscal year. They must first be approved by the Chair, the Dean’s Office, and, if applicable, the Office of Research before participating in the outside activity. If a material change in the information presented occurs during the year, a new form must be submitted. All paperwork associated with continuing outside employment/activity must be renewed on a fiscal‐year basis.

• Outside agreements must reference the individual’s home address and compensation must be paid to them acting in a private capacity.
• Compensation must reflect Fair Market Value.
• Reasonable travel expenses may be reimbursed by Industry or other entity.

Discussion

Many of the rules are fair and balanced.  The prohibition of samples and speakers bureaus is an unfortunate side effect of the endless barrage on freedom of association by the Association American Medical Colleges (AAMC).  It is unfortunate that universities adopt these policies.  Perhaps in several years from now we may see a shift back to allowing samples and physicians to speak on products to other physicians in their community.