Life Science Compliance Update

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23 posts from December 2010

December 30, 2010

Thomas Stossel: Money in Medicine a Sin or Salvation

Thomas_P__Stossel 
As part of Harvard University’s lecture series on Institutional Corruption at the Edmond J. Sarfa Foundation Center for Ethics, Thomas Stossel, M.D., recently lectured the participants and asked is “Money in Medicine a Sin or Salvation?”

He structured his lecture to first provide a context of health care money parameters in general, and then focused on medical product company money in medical innovation and education. The second part of his lecture focused on what he believed is most important: value and the difficulty in getting to value. Finally, Dr. Stossel reviewed the history and effects of allegations of corruption, and presented an analysis of such allegations and their effects.

MONEY IN HEALTH CARE

Although Dr. Stossel noted that today some people are concerned that industry funding is considered tainted, people were also suspicious of Government funding after WWII. Accordingly, he asserted that “all sources are tainted” because there is never enough money to support the possible missions of universities, and for this reason alone, money in health care is “salvation.”

Money in health care, such as NIH funding, which is always justified as leading to “health,” is limited by political vagaries and spending limits. There is also an enormous gap between the sources of funding for NIH and industry, and such a gap is unlikely to change in the current economy.  Moreover, he added that the ability to recruit further prospects for persons to sustain a research career at NIH “appear grim.”

Accordingly, he recognized that “the only realistic supply of added funding for research and employment is industry.” This unavoidable fact must be addressed soon because presently less than 4% of university research funding comes from industry, and if more money was to flow in, researchers, breakthroughs, clinical trials and innovation would soon follow.

VALUE FROM HEALTH PRODUCE MONEY?

Dr. Stossel defined value as increasing longevity, reducing pain, and improving life quality from a health standpoint. Using his experience working as an intern at MGH in 1967, he remembered how unsafe medicine was and how access to care was poor, and there were large discrepancies between community and academic, urban and rural medicine. He explained that “the difference between then and now is not that physicians became smarter or more ethical or self-denying. Rather, the difference is because of tools provided by industry and abetted by a bi-directional flow of information and action between academe, physicians and industry.” 

To emphasize the importance of industry, Dr. Stossel used slides in his lecture to give a long list of products available today because of industry that were not available back in 1967 when he was an intern. Some of these products Dr. Stossel noted, have helped mortality from cardiovascular disease fall steadily by half, and cancer mortality to remain flat and at an all-time low.

While many factors contribute to this incremental reduction in mortality, he noted that economists attribute health care products by industry as the most important and major contributors to clinical value. Economists further add that publicly funded research although important, is insufficient. Particularly, Dr. Stossel discounted the claim that “NIH mines the gold that companies then take to the bank” as being false largely because “the return on public investment has been amplified many-fold by industry contributions.” This investment by industry in health care is significant because medical innovation is much harder than other industries to improve outcomes because of how heavily regulated it is.

Another difficulty for medical innovation is the “high expense and slowness of product development, which are primarily a result of a high failure rate of what prospectively seemed like great ideas.” Without the investment from industry, the level of product development we see today would not be possible. For instance, Dr. Stossel cited the research of Ioannidis who surveyed over 25,000 articles in high-profile biomedical journals. Of these only 100, less than 0.4% even mentioned a practical medical possibility. Of those, 21 end up as clinical trials.  If an author of the paper had an industry connection, a trial was 8-fold more likely to happen. There were 5 FDA approvals from those trials, and one product is in use today. 

What this example demonstrates is that making a drug and bringing it to use are largely overcome only by immense trial and error. As a result, it is overwhelmingly because of industry profitability the enables that effort through investment. Lack of profit seriously slows innovation by limiting investment, and the history of biotechnology entrepreneurship illustrates these limits.

Following up on this notion that profit is necessary for innovation in the drug industry, Dr. Stossel notes that it was not Bayh Dole that was responsible for the increase in physician and academic interaction with industry. Rather, it was the revolution of recombinant DNA technology. Those prominent academics, including Nobel laureates, who were involved in early biotech increased interaction because by straddling academe and industry, these researchers retained their cache value that unlocked investment from venture capital. Their networks facilitated talent recruitment and other technical contributions to product development. With this kind of collaboration and progress however, came concerns in the late 1980s of alleged corruption from financial entanglements.

These accounts ignored “professional ambitions” and fixated on “trade interests,” because it was easy to count the money. Eventually the code word for the alleged corruption became “conflict of interest,” something Dr. Stossel correctly called a “meaningless epithet.”

He further added that conflict of interest (COI) merely represents a framing bias that once accepted, infers a problematic situation where risks eclipse benefits and must be managed. Our country’s founders rejected such management. In fact, Madison wrote that removing conflicts (or factions as he called them) violates liberty, and rather, we should address effects of conflicts with checks and balances, not conflicts per se. Despite Madison’s words, health care has gone a different way, and today academic and state regulations:

  • Invade privacy and mandate mass confession;
  • Restrict freedom of speech, association and rewards for excellence; and
  • Empower poorly accountable authorities.

The problem with these regulations is that they have opened the door to more intrusive interference, when the regulations have all been justified by severe allegations, such as:

  • Industry is inherently corrupt;
  • Physicians cannot cope with industry marketing; and
  • Industry association for pay is simply unethical, and it alarms the public.

In addressing these allegations, Dr. Stossel noted that considering the size of the health care enterprise, there would be more instances of corruption however, the legitimacy of these incidents are weak evidence for such corruption. For example, the list of incidents ascribed to industry corruption is strikingly short especially in the context of benefits shown previously.

Second, the damages from financial relationships between industry and physicians are not comparable to corporate fraud and the mortgage meltdown. Lastly, the incidents and cases listed represent what Harvey Silverglate has pointed out as prosecutorial extortion racket that doesn’t address any damages. In fact, while the companies usually settle because of a threat of debarment, individuals who defended themselves in court won easily. 

NO DIRECT EVIDENCE FOR COMMERCIAL BIAS IN CME

Moving back to CME, Dr. Stossel asserted that despite widespread speculation to the contrary, four papers in the past year reveal no perception of bias in CME due to commercial support of it (Cervero & He; Ellison et al; Steinman et al; and Kawczak et al). In fact, Kawczak’s paper included a survey of almost 100,000 physicians at Cleveland Clinic. As a result, there is very little direct empiric evidence for corruption, explaining why the allegations rest heavily on indirect or even false evidence.

For example, using brain imaging to make a case for corruption is indirect because such experiments are “insufficient to justify coercive policies” according to Dr. Stossel. With regards to false evidence, Dr. Stossel examined the Wazana study, which was problematic because her study tried to show how interactions with industry hurt clinical care without using any information about clinical care—and Wazana explicitly says so. So the statement about clinical care in the policy paper is false.

Also troublesome with Wazana’s paper was how it documented positive and negative outcomes of industry interactions with physicians. On the positive side was “improved ability to identify the treatment for complicated illnesses.” On the negative side was “non-rational prescribing,” based on a single Dutch study. The arbitrary assignment of fast prescribing or formulary requests to the negative column is not justified, because these behaviors could benefit patients, according to Dr. Stossel. He also noted that Wazana’s paper was disrespectful to drug representatives, something he has personal experience with (his wife).

COSTS OF BAD POLICIES: ABUSE OF “TRANSPARENCY”

Dr. Stossel noted that attempts to limit industry funding through transparency are “muddled” because it’s used for promoting activist and litigation agendas that:

  • Impair risk taking and investment in early innovation;
  • Decrease CME (less training and education);
  • Promote what is called clinical inertia, meaning doctors don’t get information they need;
  • Promote inexpert education; and
  • Cause waste – Mass Law is supposed to save money but it will cost the State far more than it will save. 

Even more troublesome is that the ideology driving these regulations lacks empiric evidence, uses faulty logic and confuses merit (what you believe) and value (longevity and life quality). Those that are confused by merit and value claim that physicians are subtly inclined to please financial sponsors. While physicians have to please sponsors to get funded (like politicians please voters to get donations), that doesn’t mean sponsors don’t want them to aspire to truth. The fact is, “scientific integrity isn’t absence of bias, it’s doing experiments designed to falsify, not confirm, your hypotheses.”

Consequently, those who believe that it is fine for industry to make products– but it’s not allowed to sell products or pay physicians or academics for helping them make and sell products are misguided. Why can medical journals, profitable businesses propped up by company advertising, aggressively sell reprints to companies that publish articles in the journals? Why can a journal editor accuse Dr. Stossel about making decisions based on sponsorship, but he can’t speculate that an editor will be inclined to publish a paper reporting results favorable to a company, because that company will purchase reprints?

The reality is doctors must take risks to survive down in the ranks because they can’t sustain a practice, fund a research project, publish a paper, and secure investment for innovation without aggressive promotion. This kind of survival however, requires some financial supplementation from the academic leadership. Limiting a physician’s commitment to industry or academia almost assures that physicians will have neither security nor the hope of reward.

Another bad policy effect is the use of civilians to frame policies because they are inexperienced, and use their imagination to craft transparency regulations. Additionally, using so-called “experts” on “conflict of interest” is also inappropriate because these are people who perform surveys, who are policy entrepreneurs or ethicists who make their living or have staked their prestige on promoting the dangers of industry relationships and on strict regulation of them.

MONEY IN HEALTH CARE: SIN OR SALVATION?

In the end, Dr. Stossel asserted that his beliefs represent the aspirations of health care providers, innovators and educators who want freedom, moderation and common sense to generate value—firm beliefs held by a silent but unfortunately fragmented and intimidated majority.

Central to his ideology is that industry-academic collaboration should emphasize value for patients, not institutional “missions,” “institutional integrity” or “disinterested advice.”  Considering Plato himself noted that physicians are both healers and moneymakers, today we should regard them no differently because evidence clearly shows that the health products of industry have added immense value to physicians and patients. One has to only look at the chart in Dr. Stossel’s presentation which displayed how the numbers of persons over 100 years of age has grown significantly over the past few decades because of the success of industry investment in research.

In addition, industry-academic partnerships are not of concern to the public because surveys have shown no decline in physician esteem; two-thirds of respondents believe researchers should profit from their discoveries; and an overwhelming majority of patients enrolled in clinical trials have no concerns about financial relationships of their physicians conducting the trials.

With many potentially lifesaving technologies languishing in pipeline, especially now, because the investment ecosystem has seized up, creating new policies that restrict collaboration with industry will hurt patients tremendously. Accordingly, if not accepting money or gifts from companies makes a physician feel good – fine, but to say that doing so makes them a better physician, innovator or educator than someone who accepts such payments – without substantive evidence – is disrespectful, false, and damaging.

Dr. Stossel concluded his lecture by referring to the non-profit he and his wife founded to provide volunteer dental prevention and management of sickle cell disease in Zambia. He mentioned this work because his “corporate earnings enable him and his wife to do what they do, not some other agenda or want. In other words freedom begets freedom.  He and his wife would not have this liberty if Dr. Stossel had been forced to limit his earnings to his academic salary. As a result, he told participants that if they visited the country with them, they would see graphically that it is not money but lack of it that is bad for health care.

 

December 29, 2010

David Korn: Financial Conflicts of Interest In Academic Medicine – Why is He So Vexed?

David Korn
Continuing Harvard University’s lecture series on Institutional Corruption at the Edmond J. Sarfa Foundation Center for Ethics, David Korn, M.D., recently lectured the participants about "Financial Conflicts of Interest in Academic Medicine: Whence They Came, Where They Went, Why They Vex Us So." As the second speaker in the field of medicine to address institutional corruption, Dr. Korn professed to be a “moderate” between Dr. Angell and Dr. Stossel.

Dr. Korn, who attended Harvard for undergraduate and medical school, began teaching and researching in the late 1960s, and eventually went on to become the Dean of Stanford’s Medical School. He was also a professor of pathology and vice provost of research.

Conflict of Interest (COI)

In beginning of his lecture, Dr. Korn framed the definition of COI by using the Institute of Medicine (IOM) report from April 28, 2009, which stated that:

“A COI is a set of circumstances that creates a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”

Dr. Korn further explained that a COI describes a situation and is not per se a judgment about the character or actions of an individual. Instead, a COI is a set of circumstances that either exist or don’t exist. Looking at it from the behavioral economic perspective, George Loewenstein observed that:

Traditional economics assumes that professionalism and COIs are asymmetric motives in influencing behavior, and that persons who confront COIs are equipped to deal with them rationally.

Behavioral economics posits a more complex model of decision-making, one that includes unconscious motives and other factors outside the control of a purely rational process; biases are viewed as unconscious.

History of COI

Dr. Korn then traced the history of COI back to the late 1970s and 1980s when there were financial COIs with flagrant scientific misconduct that gathered significant major media coverage. In response to this publicity, Congressional hearings were held between the 1980s and 1991, the outcome of which produced a House Committee on Government Operations report titled: “Are Scientific Misconduct and Conflicts of Interest Hazardous to Your Health?”

While investigations were taking place, Congress also directed the Public Health Services (PHS) in 1985 to begin regulating scientific misconduct.  (It should be noted the problem was largely limited to government supported research).  This regulation eventually led to PHS issuing formal regulations of scientific misconduct in 1988. This was the first time congress asked the government to regulate conduct of federally funded research. Previously, conduct had been left to oversight of academic institutions.

The outcome of these regulations was to prevent fabrication, falsification, and plagiarism in the conduct of federally funded research. He said that such light handed regulations were what academia wanted. In other words, if the government was going to be involved, academia wanted to limit their involvement.

Also occurring in 1988, Congress directed the PHS to regulate financial COIs. These regulations were eventually issued in a 1995 PHS report on financial COIs called, “To Ensure the Objectivity of Research.” Dr. Korn noted that the regulations from this report are still in place today. Dr. Korn called these regulations “light handed” because it only requires institutions that receive federal money to have policies in place and enforce these policies to detect financial COIs in individuals who are going to receive federal funding. Dr. Korn’s issue with this regulation is that there is no requirement to say what the conflict is, what kind of conflict, or how much it is. The regulation states that you only have to identify it and take care of it.

What members of academia feared then, and most continue to be afraid of now, is the political interference with academic and scientific matters the government would have.

If the issue is being managed or resolved in accordance with an institutions policy, and the management of the COI has been reported to the federal agency, why do we need more government oversight?

1995 – 2000

Dr. Korn’s lecture then progresses to what he refers to as “scathing reports” and the President’s Commission, which focused on institutional review boards (IRBs) who had conducted military experiments in WWII that nobody knew about. Since these reports were coming from DHHS, OIG and GAO the focus on COIs moved from individual to institutional, and people began to ask how can we trust an IRB if the institution itself has a financial investment in the research itself?

In response to this concern, the National Bioethics Advisory Commission (NBAC) was formed during the Clinton Administration, headed by Harold Shapiro, with a focus on human subjects research (HSR). NBAC Called for enhanced institutional management of institutional, IRB and individual financial COIs.

Another problem that brought attention to COIs took place when three research subjects died in two clinical experiments, which were physiological trials, not drug trials. One was an interventional trial. The deaths increased calls for enhanced federal oversight, which resulted in the Office for Protection from Research Risks (OPRR) shutting down and suspending human subject research (HSR) in major research universities, which also drew attention.

In addition, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was also created in response to negative attention, with the responsibility of accrediting human research programs. There was also the formation of the Association of American Medical Colleges (AAMC) Task Force, which Dr. Korn believed helped to “lower the temperature in Washington.” He also added that the creation of these entities during these events helped avoid some serious speculation.

The first AAMC Task force, which Dr. Korn was a member of, issued a report titled: “Policy and Guidelines for the Oversight of Individual Financial Interest in Human Subject Research: Protecting Subjects, Preserving Trust, Promoting Progress (December 2001). Dr. Korn believed the report was very influential, and was directed to medical schools and teaching universities.

The Task Force did not use an absolute prohibition on pursuing HSR research in which one has a financial stake. Instead, the report established a rebuttable presumption, and stated that research may be pursued if the researcher can establish "compelling circumstances." Among the relevant considerations that make circumstances "compelling" are the nature, magnitude, and "relatedness" of the interest, and the risk to human subjects and to the scientific integrity of the research that these interests pose. The report also noted that circumstances may be compelling if the research could not otherwise be conducted as safely or as effectively. Dr. Korn argued, if that were the standard of compelling, there would probably be fewer financially conflicted individuals.

In October 2002, the same Task Force created: “Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research: Protecting Subjects, Preserving Trust, Promoting Progress II.” This task force defined an Institutional COI (ICOI) to exist whenever the financial interests of the institution, or of an institutional official or committee, create a risk of unduly influencing institutional processes for the review, conduct, or oversight of [human subjects] research.

Dr. Korn acknowledged that a core management principle of institutional COIs is a separation of functions. Specifically, institutional administrative functions and responsibilities related to the oversight of [human subjects] research should be cleanly separated from those related to investment management and technology licensing. He recognized that most major research institutions have this kind of separation.

He then referred to the “partnership,” wherein the university community, protective of academic freedom and institutional autonomy, got the federal government to agree to delegate to the universities major responsibilities for the oversight of federally funded research. He called this the “assurance mechanism,” which he noted is still in use today. Since this assurance is based on a relationship of trust, Dr. Korn noted that institutional COIs are so vexing because when they occur they “shake the assumption of the trustworthiness of the institution.”

21st Century

Moving into the first decade of the 21st century, Dr. Korn highlighted cases of financial COIs such as GSK for suppressing negative clinical trial results of antidepressants; and NIH’s year of embarrassment and draconian regulations in 2004-05 in response to senior scientists engaged in transactions with industry.

NIH responded to their COIs by barring all interactions of NIH researches with industry. This then led to members of Congress to ask “if this is good enough for members of the NIH, why should it not be good for awardees of NIH grants?” That question is still active in Congress, Dr. Korn noted.

He also brought up the 2006 NIH report of its Targeted Site Reviews (TSRs) at 18 awardee institutions, public and private, which identified that the definition of “investigator” was too narrow; required reports to NIH were submitted erratically, if at all; and subrecipient monitoring was poor.

OIG issued a severely critical report of NIH, and Senator Charles Grassley (R-IA) followed-up OIGs report by requesting information regarding certain reports from NIH TSRs. There was also a letter from House Members Dingell and Stupack concerning the National Cancer Institute (NCI) lung cancer trial testing value of CT chest scans, in which the principal investigator had 12 patents on technology related to the research.

Subsequent to these developments, another letter was sent to NIH in February 2008 to 19 institutions requesting detailed information about COIs reported to NIH. There was also former US Attorney Christopher Christie (NJ) who subpoenaed records of payments to physicians from orthopedic device manufacturers that led to a multi-hundred million dollar penalty and agreement to post all such payments on their company websites. Then Senators Grassley and Kohl sent letters to university and hospital presidents alleging failures of Key Opinion Leader (KOL) physician scientists to fully and accurately disclose payments from industry vendors.

 In a seemingly rapid response to such investigations, Dr. Korn noted that increasingly, vendor companies are now disclosing payments to physicians, sometimes voluntarily, sometimes as a result of settlements with the DOJ, for example: 

  • 2008 Cephalon; $425 Million Corporate Integrity Agreement (CIA);
  • 2008 Eli Lilly, $1.4 Billion CIA;
  • 2009, Pfizer, $2.3 Billion CIA; and
  • Voluntary: Merck, J&J, GSK, AstraZeneca.

Dr. Korn also mentioned an AAMC-AAU Workshop in September 2005, which highlighted a lack of consistency in policies and practices across institutions; and a conflict of public expectations. Specifically, the public wanted to see more and more results and tangible benefits, and at same time want researches and institutions to be as pure as possible. He noted this as a conflict for institutions and faculty to manage because by interacting with industry, and commercializing there discoveries, they are realizing one benefit but still have to remain “clean.” He also discussed the AAMC-AAU Advisory Committee in 2006-08, which put together a “How to Do It Manual,” for implementing effective and comprehensive COI programs.

Medical Education

Dr. Korn then shifted to the AAMC Task force study on: “Industry Funding of Medical Education.” He noted the report to find concerns associated with industry funding of Medical Education such as:

  • Conflicts of Interest;
  • Compromise of objectivity;
  • Integrity of professional decision-making;
  • Blurring of marketing and scientific evidence;
  • Distortions in prescribing or in formulating practice guidelines;
  • Hidden curriculum for students and trainees;
  • Growing body of scientific evidence about reciprocity and influence; and inadequacy of disclosure as safeguard.

He tried justifying such concerns from presentations given at a symposium on "The Scientific Basis of Influence and Reciprocity" organized by the AAMC. There, speakers discussed the typical MRI imaging studies (that we have dismissed since they use no clinical data), and the idea that people grant themselves moral "wiggle room" within which they can behave deviantly without letting this impair their self-image.

Using this highly controversial research, Dr. Korn raised a number of questions about the proper institutional response to COIs: Should management of COIs be based on a weighing of risks, or should it be formulaic, drawing "bright lines" that may not be crossed? In addition to these questions, he also discussed NIH’s ANPRM in the spring of 2009, and OIG’s November 2009 report, which requested detailed COI information from 41 awardee institutions. The report found:

  •  90% of awardees rely “solely on researchers’ discretion to determine which financial relationships should be reported;”
  • Less than 50% of awardees to not require specific values;
  • No routine verification of information provided;
  • Lack of management documentation; and
  • Awardees not required to report their own financial interests with outside; research-related entities

As a result, OIG recommended that awardees:

  • Report COI details to NIH and collect information on all SFIs held by researchers;
  • Develop methods to verify reported financial interests;
  • Ensure proper documentation and appropriate awardee enforcement;
  • Require NIH to increase oversight; and
  • Develop new regulations that address institutional COIs (process is underway).

Conclusion

Interestingly, since Dr. Korn noted that today it might be impossible to find uninvested experts because of the prevalence of industry relations, who can carry out federally funded research that has the right expertise and experience?

If “it’s important for academic scientists to contract with industries that make their work useful for the public, and since those relationships can be managed through institutional policies that are enforced,” as Dr. Korn states, what is the need then for extra oversight? There is no need to respond extremely to recent cases since industry and institutions are doing so on their own.

Accordingly, because duties have become more difficult to live up to as demands for tangible results in research (made by both universities and public funding bodies) have put pressure on physicians commitments to institutional and individual integrity, a more common sense approach is needed. This kind of perspective is important because COIs   are particularly troubling because they threaten the long-standing partnership between universities and the government. As a result, Dr. Korn’s recommendation to use guidance by judgment rather than overregulation, will achieve the best balance for managing COIs without hurting patients or relations with physicians and industry.

December 28, 2010

Marcia Angell is Academic Medicine For Sale or Conflict for Sale

Conflict for sale 
Over the next few days we will be posting articles based on a series of lectures that were presented at Harvard University earlier this year.  They represent the two views of industry relationships (pro and con) and an additional view from a carrier bureaucrat calling for more stringent regulation.

Harvard University’s Edmond J. Safra Foundation Center for Ethics has conducted a lecture series focused on Institutional Corruption. In December, Marcia Angell-Relman, M.D., the first woman to serve as acting editor-in-chief of the New England Journal of Medicine (NEJM), gave an hour lecture which focused on conflicts of interest (COI) in academic medical centers (AMCs), and continuing medical education (CME). After the lecture, she responded to questions from the audience, which consisted of numerous Harvard faculty.           

Introduction

Dr. Angell began her lecture by noting an article she wrote in May of 2000 titled, “Is Academic Medicine For Sale?” The article focused on the clinical trials of an anti-depressant Serzone, and the authors of a paper who had financial conflicts who apparently had financial disclosures that would “have been as long as the paper.”

She used this as an example of the “hardly unique” occurrence of physicians in AMCs being paid for work by pharmaceutical companies. She cited that nearly 94% of physicians take money or gifts from drug companies, and that many are paid speakers, consultants, and authors of papers.

It was clear from the onset of her discussion, that her one sided approach would be a critique of drug companies involvement in the work and research of physicians in AMCs, instead of a balanced consideration of the risks and benefits.

Drug Industry

Dr. Angell’s concerns stemmed from drug companies that subsidize meetings and CME; doctors who are reimbursed for attending those meetings and programs; and the billions of dollars industry uses each year to “influence the way doctors use drugs.” Contrary to her claim, a recent article in the Journal of Academic Medicine found that to date, “no published studies have addressed the relationship between commercial support and perceived bias in accredited CME activities.”

 

Part of her worry about the relationship between academia and industry is that the goals and missions of AMCs are being blurred. While she sees the mission of AMCs to educate the next generation of doctors, partake in important research, and take care of the sickest and neediest patients, she sees drug companies only out to increase shareholder stock.

 

She goes even as far as saying that drug companies do not seek to educate doctors because they do not have education budgets, they have marketing budgets.

 

The lecture then moves to clinical studies, which Dr. Angell claims are used by companies to get their drugs used for other uses, to show advantages of their treatment over another, or to get physicians to prescribe their drug. What exactly is wrong with companies wanting doctors to prescribe their drugs to help patients, and to show the advantage over another treatment? This claim is especially disturbing because as Dr. Angell herself explains, all clinical trials are required to have FDA approval, and must show the drug is reasonably safe and effective compared with a placebo. With this kind of oversight, where is the conflict?

Dr. Angell believes that when drug companies contract with AMCs to conduct clinical trials, the potential for COI is significant. She explained that until the mid 1980s, drug companies gave research grants to AMCs to run trials that were investigator initiated, and that the researcher thought was scientifically or medically important. At that time, she noted that drug companies had no part in designing studies, did not own data, or write papers, or control publication. Today however, Dr. Angell is concerned because she thinks this kind of relationship no longer exists.

She associates part of the influence from the fact that the drug industry has enormous power and influence, and because AMCs have fallen on difficult times, mainly from shrinking reimbursement on clinical trials and treatment.  It would therefore seem that industry is providing tremendously important clinical experience to researchers, that otherwise might not be affordable for the AMC to partake in.

But Dr. Angell sees drug companies using AMCs to increase their chance of getting work published on their drugs because it gives the companies access to highly influential professors, known as Key Opinion Leaders (KOLs), who write textbooks, journal articles, sit on FDA panels, etc.

Conflict of Interest

Dr. Angell proposes a radical COI policy because present COI rules are highly variable, highly permissive, and loosely enforced. She notes that at Harvard, no COI is flatly prohibited only limited in various ways. She believes such policies are loose because AMCs don’t want to lose their “stars,” who are custom to supplement income with deals with industry.

She associates part of the problem with AMCs and industry to the Bayh-Dole Act of 1980. This legislation permits, but does not require, universities to patent studies from government funded research and then to license them to companies in return for royalties. Similar legislation exists for work done in NIH. She acknowledged that “industry and academia are partners, both benefiting from public support.”

Dr. Angell noted that the original purpose of the act was to speed the discovery stage to practical use, but she believed that it was eventually used improperly to increase the number of patents, and not their quality. She noted that a number of schools now have technology transfer offices to deal with the results of new patents and licensing. How does this kind of partnership, both benefiting from public support, constitute a COI?

The cause of her concern is that she sees industry setting the research agenda in AMCs, which is focusing too much on targeted applied research and drug development, not causes, or mechanisms or prevention of disease. She is also worried about drug companies using AMCs to carry out studies for entirely commercial purposes, for example pitting 2 drugs against each other.

Although she believed that it is important that researchers have no financial stake in the outcome of their research, she did not object to all collaboration between academia and industry. Her main objection was only to terms and conditions that pose real threats to the independence and impartiality of medical research.

At one point, she even asserted that “collaboration between academia and industry can be fruitful, but only if it doesn’t need to involve payments beyond grant support.

Continuing Medical Education

Dr. Angell believed that the influence of industry is perhaps the greatest in CME, and has the least justification because they just want access to the best medical schools and young doctors to influence their prescribing habits. The problem with this assertion is that she forgets the role ACCME plays in accrediting Medical Education Companies, and the guidelines which make programs free from drug company influence.

Her biggest argument against industry funded CME is that if it were really education, the doctors “would pay them for their services.” The added cost of travel, lodging, food, expenses associated with leaving the practice, and other considerations make paying for CME extremely difficult, especially when programs are not evenly dispersed geographically.  Additionally, she thought it was “absurd to look to drug companies for critical unbiased education about products their selling,” which was akin to looking to a beer company to for information about alcohol education.

Seemingly, she believes that the one thing doctors do learn from CME is to practice drug intensive style of medicine, even when changes in lifestyle would be more effective. This includes being “convinced that the newest most expensive drug, is the best treatment, even though older or generic drugs are available.” Ultimately, she believes that industry has no legitimate in role in CME, and it should be the responsibility of the profession.

Recommendations

In closing her discussion, Dr. Angell noted that although “industry-academic collaboration can make meaningful scientific contributions, it does not necessitate a personal enrichment of doctors or researchers. She recommended that:

1)    Medical school faculty who conduct clinical trials should not receive any money from the drug companies except for research expenses. That support should have no strings attached, no control over design, publication. Faculty should also not enter deals of products faculty are studying’

2)    Doctors should not except gifts from industry, and should pay for own meetings and CME; and

3)    AMCs that patent discoveries should put them in public domain or license them nonexclusively, like Stanford.

Dr. Angell also noted that medical journals should not publish papers whose authors have other ties to sponsors of researchers. She also asserted that while disclosure is better than nothing, she believes it does not eliminate conflict, it only passes the burden to someone else. After her speech she went on to take questions from members of the lecture, mostly Harvard faculty from other schools.

Opinion

A one sided lecture such as Dr. Angell’s is extremely difficult to value since it merely attacks industry, without giving industry a chance to defend itself, or to consider the numerous benefits associated with industry-academia collaboration. Such a narrow focus on the few cases that COIs have existed only unnecessarily labels the successful relationships negatively. Some of the questions Dr. Angell addressed were concerned with her “radical” approach. Others were worried that changing the way industry and academia practice medicine could introduce a new type of COI, where the government tells doctors what to prescribe because they are merely trying to save money on government programs like Medicare.

Ultimately, an entirely different discussion that takes into account the benefits of academia-industry relationships is needed. This discussion should address some of Dr. Angell’s concerns about disclosure and COI, but should also focus on the importance industry-academia collaboration bring to developing new medicine, treatments and devices.

If you want to watch the lecture click here.

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