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.