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May 21, 2010

Boston Review: Stossel Standing Up to the Unhealthy Opposition


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


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


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


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


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

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

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

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

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

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

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

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

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


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

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

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


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