Doctors or Entrepreneurs? The Triple Mission Problem.

Posted on | November 22, 2019 | 2 Comments

Mike Magee

This week’s blockbuster investigative article in Science doesn’t pull punches. Its’ headline: “Investigation reveals widespread double dipping in NIH program to pay off school debt.” The article cites incontrovertible evidence of taxpayer dollar support for student debt loan forgiveness being granted to many clinical investigators (more than half MD’s) who are on for-profit industry payrolls. More than this, rules designed by the NIH itself to curtail double dipping and blatant conflict of interest rules were found to have been broken by the NIH and sponsoring academic institutions in 1/3 of the 182 cases studied.

The history of research fraud and abuse is covered in exquisite detail in “Code Blue: Inside the Medical Industrial Complex.” Spanning eight decades since WWII, academic medical leaders have been able to “have their cake and eat it too” by embracing the concept of a “triple mission” – as clinicians, educators, and researchers all in one. Fraudsters like Arthur Sackler knew well the value of wrapping themselves in academic garment – creating institutes, fraudulent journals, and bogus publications – to create professional CVs and public biographies that defined them as saints when in fact they were sinners.

This mingling of roles is somewhat unique to the Medical Industrial Complex (MIC). Even the Military Industrial Complex recognizes that Boeing is in the job of generating profit; that their paid research promoters are required to register as lobbyists, and that transparency and checks and balances are necessary to challenge outright greed and avarice.

The MIC supply chain, which now controls 1 in every 5 dollars in America, casts a wide net, and includes medical journals (dependent on income from advertising and reprint sales), continuing medical education, voluntary accreditation services, patient advocacy non-profits, and contract research organizations (CROs).

Attempts to bring rule-breakers to heel have repeatedly failed due to “triple mission” comingling. For example, to combat fraud by increasing transparency, in 1997 Congress passed the FDA Modernization Act, requiring that studies for life-saving drugs be registered on a new website, ClinicalTrials.gov, when the studies were initiated. The FDA broadened its criteria for which studies needed to be registered. After four years of experience, it was clear that companies were not rushing to the land of transparency. So, in 2004, the International Committee of Medical Journal Editors, which included editors from JAMA and the New England Journal of Medicine, elected to use their own power to force early disclosure of all studies. Their lever was a declaration that they would no longer publish research papers based on studies that had not first been formally registered on ClinicalTrials.gov.

When the $700 billion pharmaceutical industry threatened to cut off millions of dollars of advertising revenue, the standards-defending editors folded like paper tigers. They knew all too well that drug money, paying not just for ads but for bulk reprints of individual favorable articles, which their reps distributed to doctors, kept these journals alive. Debate and critique played out in critical articles in the journals themselves. For example, a JAMA article in 2009 criticized editors for purposefully vague directives such as “We encourage the registration of all interventional trials.” Authors also shared their analysis of the results of 323 clinical drug trials in the 10 top medical journals in 2008 and found that 176, or 55 percent, were inadequately registered.

In 2007, Congress ramped up oversight with an FDA Amendment Act requiring that all pharmaceutical trials, at any stage in the development process, be registered. It further required that all results, positive or negative, be posted on the site within one year of completion. Five years later, only one in five studies had met their obligations. A review of 8,907 studies that underwent mandatory registration on the government site over a three-year period (2009–2012) found that less than half had reported any results of those trials at all on the site. Five years later, a 2018 investigation revealed that barely three-quarters of the ongoing clinical trial studies had been registered to the site, and journals have not fully embraced the role of policemen for the government’s trial transparency efforts.

In some cases, academic researchers need only lend their name and credibility. For example, a 2011 study that analyzed 630 publications in JAMA, Lancet, the New England Journal of Medicine, Annals of Internal Medicine, Nature Medicine, and PLoS Medicine determined that, based on the voluntary admissions from the 70 percent of authors contacted who agreed to participate in the confidential survey, industry-hired consultants (ghostwriters) were involved in manuscript preparation in 12 percent of the research articles, 6 percent of the review articles, and 5 percent of the editorials—and that is without considering the 30 percent of authors who chose not to participate in the survey.

The numbers on first glance may appear to be small, but they are more than enough to undermine the credibility of these premier medical journals and undermine public trust in the medical evidence presented in these publications.

Any new health care system the nation develops should dismantle artificial protections for academic medicine’s “triple mission”. With 20% of the GDP in tow, medical research, like military research, can more than stand on its own two feet without shielding its behavior behind direct patient care activities. Entrepreneurial medical researchers deserve to be rewarded for their discoveries, but should not be confused with patient care physicians whose stock in trade is compassion, understanding, and partnership, and not dreams of fame and fortune.

Comments

2 Responses to “Doctors or Entrepreneurs? The Triple Mission Problem.”

Charles Fahey
November 23rd, 2019 @ 10:45 am

thanks Mike and happy Thanksgiving to you and all dear. Chuck
Mike Magee
November 23rd, 2019 @ 12:54 pm

Blessings and Happy Thanksgiving, Chuck!