Wednesday, February 20, 2013

The Enterprise Risk from Dubious or Unethically Conducted Research to Population Health Management Companies & Ten Options That a Board of Directors Should Consider to Mitigate that Risk

To:        Chair of the Board, Any Population Health Management Service Provider Company
From:    The Disease Management Care Blog
Priority: High
Date:     Feb. 20, 2013
Re:       Implications  of "Research" for your company's "Enterprise Risk Management"
Thanks to the 2004 Congressional Budget Office analysis and similar reports questioning the value of "disease management," our industry responded with more than just a name change to "population health management." It also committed itself to conducting credible research and being subjected to the scrutiny of public domain, transparent and high quality peer review. Examples like this and this are, in no small measure, responsible for our industry's growing credibility. Not bad, considering critics like this predicted a lack of quality and cost-savings evidence would result in the industry's becoming "just one more policy failure."

Unfortunately, however, what your senior management team is not telling you is that public domain, published or peer-reviewed research is highly vulnerable to data manipulation, conflicts of interest, skewed results, suppression of negative results and spin.  The blowback from bad research can be considerable and the misconduct can result in embarrassing and highly public retractions.  The pharmaceutical industry has become the poster child for this sort of bad behavior, resulting not only in considerable fines but long term reputational damage.  It will take years to repair.

To date, the Disease Management Care Blog is unaware of any research bad behavior in the population health management vendor community.  However, given the premium placed by purchasers on demonstrable proof of a product's superiority, a highly competitive environment and the hunger of marketing departments for scientifically validated value propositions, the DMCB suspects it's just a matter of time.

As you know, a Board's commitment to Enterprise Risk Management (ERM) should not be underestimated. If your company is conducting research that is a) destined for the public domain and b) being used as any part of any marketing strategy, the temptation to "fudge" results is no less than "cooking" financial results.  Undoubtedly, your Audit Committee, in its duty to ultimately oversee ERM, rigorously oversees regular audits of internal financial controls and reports. 

Given the reputational risk to your company, the same discipline should be applied to your research shop.  This should not only include research publications, but outcomes reported in public meetings, "webinars" or in "white papers" that are distributed outside the company or posted with public access on your or any business associates' website.

The DMCB is not aware of a standard best practice when it comes to a Board's monitoring the veracity of its management's research. Furthermore, every company is different and leeway is acceptable.  This calls for both vigilance and flexibility.

Options to consider in mitigating the risk of dubious research include:

1) assuring two persons with separate reporting relationships have access to the original data,

2) requiring that at least two persons are independently involved in the data analysis,

3) becoming familiar with the regulatory requirements that surround any research involving human subjects

4) asking that any important findings be reviewed or validated by an internal or external third party with 1) an appropriate level of expertise and 2) no conflicts of interest;

5) reviewing whether any employee compensation incentives are unwittingly promoting unethical research behavior,

6) charging that the company "risk officer" is charged with responsibility for research,

7) assuring that "research integrity" is regularly reviewed by your Board of Directors

8) fostering healthy Board skepticism when there are outcome results that are too good to be true,

9) requiring that senior management and, in particular, the CEO are committed to and are championing the highest standards of research conduct.

10) having a proactive public relations "disaster plan" in place should any company research be called into question in the media



Al Lewis said...

Jaan, you and I must live in parallel universes because I am not aware of any wellness study that's been conducted validly. They all compare motivated active participants to some other group (usually unmotivated non-participants.) Most fail to include the initially low-risk cohort and claim credit for the downward natural movement of the high-risk cohort, and all claim credit for all cost savings whether or not related to the intervention.

Jaan Sidorov said...

Hi Al!

We agree about a lot and suspect we can both agree on the need for Boards of Directors to view spurious research as something worthy of their enterprise risk management efforts. That will include wellness studies.