For Whom the Door Revolves - from For-Profit Contract Research Organization Leadership to Surgeon General?

The new nominee to be US Surgeon General is Dr Vivek Murthy, as announced in the Boston Globe White Coat Notes blog in November.  A Boston Globe article a few days described not only his "healthy lifestyle" which included ingestion of "unflavored almond milk, raw carrots, and high-protein grains," as well as the practice of yoga, but how he has

strived to use his medical degree to help patients beyond the hospital walls through starting health care companies and nonprofits. His supporters hope that his record stands out....

While the US Surgeon General has little power, occupants of the office have tried to use it as a bully pulpit, often for public health issues.  For example, Dr C Everett Koop was known for his campaign against smoking, and his advocacy for public health measures to combat HIV.   Most previous Surgeons General came from academic, public health, and/or practice backgrounds (Dr Koop was Physician-in-Chief of the Childrens Hospital in Philadelphia; his successor, Dr Antonia Caremello was in academic pediatrics, private practice, and at the NIH; then Dr M Jocelyn Elders also came from academic pediatrics, etc.)

Dr Murthy superficially seems to come from this tradition.  The Globe article noted his "professional life as a Brigham and Women's Hospital [a prestigious Harvard teaching institution] physician."

However, Dr Murthy was also described by the official statement nominating him to be surgeon general as "Co-Founder and Chairman of the Board of TrialNetworks, formerly known as Epernicus, since 2007."  The Globe called it a "software start-up company in Needham ... to help drug developers efficiently collect information from clinical trials."

But wait, an op-ed in early December in USA Today called him a "self described passionate entrepreneur" and "a part-time physician and a full-time businessman."  In fact, the TrialNetworks web-site describes a company that

provides sponsors and CROs the industry's only Clinical Trial Optimization System. Using this modern and intuitive cloud-based technology, customers such as Merck & Co. and Infinity Pharmaceuticals are able to transform the quality and efficiency of clinical operations at each stage of a trial from feasibility through closeout. Companies ranging from biotechs to Top-10 pharmas have implemented the TrialNetworks platform for use in Phase I-IV trials by more than 25,000 site staff in 60 countries.

Thus, TrialNetworks is a form of for-profit contract research organization in that it is apparently paid by drug and biotechnology companies to help them do clinical trials and other clinical research.

Its website includes customer testimonials from  Merck, Biogen Idec, Infinity Pharmaceuticals, and Ariad Pharma.

So apparently Dr Murthy, if approved, may be the first US Surgeon General to come through the revolving door from a leadership position in a company that is a variant on the for profit contract research organization theme, an organization that supports clinical research by the pharmaceutical industry, and has major pharmaceutical and biotechnology corporate clients.  As we have discussed, most clinical research is now sponsored, and effectively run by for-profit drug, biotechnology and device companies, and is devoted to efforts by these companies to assess their own products, often ostensibly as required for regulatory approval, but often influenced by marketing considerations.  Unfortunately, the domination of clinical research by those with vested interests in having the research turn out in favor of their own products has resulted in many examples of manipulation of the research, and suppression when that manipulation has failed to produce the desired results.

So the obvious concern about Dr Murthy would be whether he would use his bully pulpit only to support patients' and the public's health,  or would his prior experience in a leadership position in commercially sponsored pharmaceutical research influence him in favor of that industry's priorities?

As we have discussed, US health care is now dominated by for-profit corporations, and these organization can command the effort of multi-million or billion dollar marketing and public relations divisions to sell their products and the policy positions they favor.  These organizations hardly are in need of more bully pulpits.  Yet it seems that this new appointment will further increase the influence in government of big health care business, rather than that of health care professionals, patients, and the people in general.

Sadly, it seems that Dr Murthy's nomination is just the latest example of how leadership of health care in government and in the corporate world now overlaps, and how the role of "pure" health care practitioners and health care academics in government has waned.  As we previously noted,  the system in which government and big corporations largely overlap in terms of their leadership and presumably goals is called corporatism.  One can argue that such systems end up being run primarily for the benefit of corporate and government insiders.

 Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.

I would note that neither the currently controversial and now operational Affordable Care Act, nor any of its opponents schemes for alternatives addresses this issue.

by Roy M. Poses MD for Health Care Renewal 

Former FDA Commissioner, CMS Administrator McClellan adds Johnson and Johnson Board Membership to Positions with General Atlantic LLC, Capital Royalty, Castlight Health, and AvivReit

Our latest example of the interchangeability of top insiders within corporate health care and the government agencies that are supposed to regulate corporate health care comes via an announcement from Johnson and Johnson,

Johnson & Johnson (NYSE: JNJ) announced today that Mark B. McClellan, M.D., Ph.D., Senior Fellow in Economic Studies, and Director of the Initiative on Value and Innovation in Health Care, Brookings Institution, will join the Board of Directors on October 15, 2013.  Dr. McClellan will serve on the Regulatory, Compliance & Government Affairs Committee and the Science, Technology & Sustainability Committee of the Board.

As former commissioner of the U.S. Food and Drug Administration (FDA) from 2002 to 2004, and as the former administrator of the Centers for Medicare & Medicaid Services for the U.S. Department of Health and Human Services from 2004 to 2006, Dr. McClellan has more than two decades of public service and academic research experience. From 2001 to 2002, he served as a member of the President's Council of Economic Advisers and senior director for health care policy at the White House. During President William J. Clinton's administration, Dr. McClellan held the position of deputy assistant secretary of the Treasury for economic policy.

So Dr McClellan has gone from running the US Food and Drug Administration, the primary government regulator of the pharmaceutical industry, to stewardship of one of the biggest pharmaceutical (and biotechnology and device) companies.

Not noted in that announcement was that Dr McClellan has been collecting positions in health care corporations since at least 2009.  The examples I found included in chronological order:

2009 - General Atlantic LLC

This appears to be a private equity firm which claims to be a "leading global investment firm."

From a 2010 a Mergers & Acquisitions article,

A year ago, the firm hired Dr Mark McClellan, previously a commissioner of the Food & Drug Administration, to its healthcare practice as a special advisor.

According to the firm's current website, he is still a special advisor.  

2010 - Capital Royalty LP

In a 2010 press release, this apparently private equity firm claimed to be

a market pioneer and innovator in healthcare investing with a focus on intellectual property investments in FDA-approved biopharmaceutical assets

In that release, it announced the creation of a Strategic Advisory Committee that included Dr Mark McClellan.  He still sits on that committee. 

2012 - Castlight Health

In a 2012 press release, this firm claimed to be

developer of a personalized health care shopping portal offering unbiased information about health care cost and quality

That press release announced the addition of Dr McClellan to the firm's Advisory Board, on which he still sits. 

2013 - AvivReit

This firm "specializes in the ownership and triple-net leasing of post-acute and long-term care skilled nursing facilities (SNFs)" per its website.

Dr McClellan is currently on its board of directors.  He apparently was appointed in 2013. 

Notably, I did not see anything in any of these firms' announcements about Dr McClellan or their biographies of him that noted his board or advisory committee positions with other firms.

Summary

Dr Mark McClellan rose through the ranks in the US executive branch ending with positions as FDA commissioner and administrator of the Center for Medicare and Medicaid Services (CMS) within the Department of Health and Human Services (DHHS).  He served under two presidents, Clinton and George W Bush.  Within 3 years of exiting DHHS, he picked up his first important commercial position, at General Atlantic LLC, and then added other positions with Capital Royalty, Castlight Health, AvivReit, and now the biggest of all, Johnson and Johnson.  Meanwhile he apparently continues at the Brookings Institution.  He must be one very busy man.

This case could be lumped with those of another former FDA commissioner and Secretary of Health and Human Services who ended up as a Director of Medtronic (see this post),  another Secretary of DHHS who ended up on the boards of multiple health care corporations (see this post), a director of the National Institutes of Health (NIH) who became a Sanofi executive, etc, etc (see this post).

While some might argue whether his acquisition of a leading advisory position with a private equity firm three years after he left DHHS technically constituted a spin through the revolving door, Dr McClellan's cumulative acquisition of four more such positions within the following four years certainly demonstrates how our corporate dominated health care system and the government agencies which are supposed to be regulating it to assure the health and safety of patients, and the maintenance of the public health seem to be run by an interchangeable cast of insiders.  We have asked before whether we can trust federal regulators to put patients' and the public's health first when they know they could easily become  candidates for lucrative private positions in the companies they regulate, or which are affected by their regulations, presumably assuming they have not done too much during their time in government to offend the leaders of such companies.

We have noted that the system in which government and big corporations largely overlap in terms of their leadership and presumably goals is called corporatism.  One can argue that such systems end up being run primarily for the benefit of corporate and government insiders.

 Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.

I would note that neither the currently controversial and now operational Affordable Care Act, nor any of its opponents schemes for alternatives addresses this issue.

by Roy M. Poses MD for Health Care Renewal 

The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

The Final Rule for Meaningful Use Stage 2 has been released.  It is at this link (PDF).  It is a mere 672 pages in length, a quick read during one's evenings of leisure.

Here is, from page 18 verbatim, the scientific justification for the program.  The finest scientific methods were used to achieve these criteria in justification of spending of $15 billion of taxpayer money in "incentives" (probably a low estimate), not counting the additional hundreds of billions the buyers themselves will spend that is diverted from your healthcare to the IT sector:

3. Summary of Costs and Benefits

This final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act.

Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule. The total Federal cost of the Medicare and Medicaid EHR Incentive Programs between 2014 and 2019 is estimated to be $15.4 billion (these estimates include net payment adjustments for Medicare providers who do not achieve meaningful use in 2015 and subsequent years in the amount of $2.1 billion).

In this final rule we have not quantified the overall benefits to the industry, nor to EPs, eligible hospitals, or CAHs participating in the Medicare and Medicaid EHR Incentive Programs. Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited. 

Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs, including reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, increased patient safety, and reduced medical errors. There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs.

There's no truly robust evidence of generalizable benefit, no randomized trials, there's significant evidence to the contrary (that, incidentally, is deliberately being ignored), there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study here) that MU and "certification" do not address, there's a plethora of hair-raising defect reports from the only seller that reports such things, but CMS justifies the program with the line:

"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."

I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science.

I recommend NIH, NSF, FDA and all other research and regulatory agencies immediately adopt this rigorous HHS methodology (called the "NWB" methodology for "nonetheless we believe") in their professional pursuits and research grant approval processes.

-- SS