Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as sleight of hand or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection to distract the viewer from seeing it.

The example, reported by Bloomberg on 26 February, 2014, is discussed late because the nature of the trick meant it took me a while before I understood how it was done.

Background

Pradaxa, a new anticoagulant, was approved by the US Food and Drug Administration (FDA) in 2010 for use by patients with atrial fibrillation to prevent strokes.  We discussed previously the release of documents during litigation that showed how marketers from its manufacturer, Boehringer - Ingelheim, attempted to manipulate the results of a clinical study of the drug.  The study results initially seemed to suggest that blood tests should be used to monitor therapy with it.  However, that would have contradicted a key marketing message, that Pradaxa was more convenient than warfarin because it did not require blood tests for monitoring.

Litigation by patients alleging that Boehringer-Ingelheim concealed the severity of the bleeding risks caused by the drug
continues.  The Bloomberg report dealt with how the company responded to requests by the FDA for data about these risks.  
 
The Question from the FDA

As per Bloomberg,

In the Pradaxa case, the regulators asked Boehringer to compare fatal bleeding reports received by the FDA against the number of patients using the drug in order to establish a death rate. The request was made to allow the FDA to 'evaluate the need for modifications to the Pradaxa label or future study,' according to a letter made public as part of the court files.

The company reported back that 6.1 of every 10,000 patients who used the drug after approval developed fatal bleeding, the court documents showed. The regulators also asked Boehringer to reanalyze results from an earlier study used to gain approval to see how that rate compared.

So, in other words, the FDA wanted to assess the rate of bleeding reflected by reports received after the drug had gone on the market (that is, the FDA was evaluating data from post-marketing surveillance.)  To do so, it wanted to calculate the proportion of patients who took the drug who developed fatal bleeding.  Then it wanted to compare this rate to the rate of fatal bleeding found in the previous controlled trials of the drug done by the manufacturer to secure drug approval.  Note that these trials are also considered the major source of clinical research evidence about the benefits and harms of the drug.

The major source of clinical evidence about Pradaxa (dabigatran) was the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), sponsored by Boehringer-Ingelheim, published in the New England Journal of Medicine [Connolly SJ, Ezekowitz MD, Yusuf S et al.  Dabigatran versus warfarin in patients with atrial fibrillation.  N Engl J Med  2009; 361:1139-1151.  Link here.]   The trial reported that the rates of life-threatening bleeding were 1.8% per year for warfarin, 1.45% for high dose dabigatran, and the rates of major bleeding of 3.36% versus 2.21%.  However, the trial report did not include rates of fatal bleeding per se, nor the rates of patients with major bleeding who then died.  

Presto Chango

According to Bloomberg, here is how Boehringer-Ingelheim responded to the question from the FDA about the rate of fatal bleeding.

That effort produced two separate analyses by the company, according to the unsealed court documents. One, looking only at people whose primary cause of death was bleeding, found 5.8 of 10,000 patients died per year. The other, which included anyone who had a major bleeding event and died for any reason, found a rate of 19.5 fatal events per 10,000 patients per year, the documents show.

 The report sent to the FDA, though, contained only the analysis indicating the death rate from the earlier research was much higher than the numbers seen after approval, according to the court filings. Potentially, such a finding could head off any after-market action by the FDA because the data showed the drug was safer after it was approved and widely used.   

So, to recapitulate, Boehringer-Ingelheim used results from the RE-LY trial to persuade the FDA that its new drug was safe and effective.  However, the company did not include, at least in the results reported publicly, any measure of fatal bleeding in patients given the drug.  It now appears that the rate of major bleeding in patients who subsequently died was high, perhaps high enough to have raised questions about the safety of the drug prior to approval, had it been revealed.

However, after the drug had been approved, when the question was about rates of severe bleeding after the drug had been marketed, the company furnished an analysis of data from the clinical trial that now showed a very high bleeding rate. That was the major misdirection, the sleight of hand.. It would make the rate of fatal bleeding in the post-marketing surveillance data appear low. 

But apparently this data also kept the eyes of the FDA focused on the question of bleeding in the post-marketing period.  Did no one in the FDA notice that while this high rate of bad bleeding in the trial made the post-marketing surveillance look good, it also raised questions about whether the drug should have been thought to have been safe enough to be approved in the first place?  


By the way, Bloomberg also reported that Boehringer-Ingelheim performed a trick for European regulators, 

Selective disclosure of Pradaxa information may have camouflaged a serious safety signal, according to an assessment report from European Medicines Agency’s Committee for Medicinal Products for Human Use in August 2012. That agency is the European Union’s drug regulator.

Boehringer also didn’t give the EMA the figures showing that real-world bleeding rates were higher when the committee conducted a similar review and published a report in August 2012. The panel’s analysis, which concurred with Boehringer’s, concluded that Pradaxa’s bleeding risks among the general population were 'substantially less' than the rates seen in the study the drugmaker used as the basis for approval. It didn’t have the analysis showing the risk was higher using a different approach, according to the unsealed files.

'If the reporting rate in the post-marketing phase had been higher than in' Boehringer’s study, 'there would clearly have been a safety concern,' agency officials wrote.

Summary

We have discussed a variety of ways that companies that sell health care goods (like drugs or devices) and services may manipulate clinical research to make their products look better than they may actually be.  It appears that these companies may hire very clever people who are very knowledgeable about the design of clinical research to game the system to aid marketing, but meanwhile obfuscate the clinical research data that clinicians and patients rely on to make clinical decisions in the best interests of patients, and that policy makers rely on to make decisions in the best interests of the public.  So far, the hands of the corporate marketers seem to be quicker than the eyes of the clinicians, patients, and policy makers.

I wonder, though, how those very clever people sleep well at night knowing that their talents for legerdemain are being used to increase revenues and make corporate insiders rich, at the expense of patients, and of patients' health?

As I have said before, and most recently in the context of discussing the previous example of manipulation of clinical research to support Pradaxa marketing,  I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been suppressed)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye. 

Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor. 

Hat tip to 1BoringOldMan.

As the Door Turns - The Ongoing Interchange of Leaders Among Large Health Care Corporations, Those who Represent Them, and Government

The revolving door is the two-way conduit between leadership positions in government and industry that helps to enable health care, and maybe all of society, to be run by a group of insiders who can move easily between large or influential health care organizations and the government bodies that are supposed to regulate, oversee, and enforce laws relevant to them.

It has been three months since our last update on the revolving door as it applies to health care, so here is our latest effort, according to the chronological order of the initial media coverage. 

Foundation Leader with Ties to Eli Lilly and to Former Synthes CEO to the White House

As reported by the New York Times in December, 2013, new White House senior adviser John D Podesta, who founded and ran the nominally non-profit organization Center for American Progress, had multiple ties to health care corporations and their leaders, e.g., to pharmaceutical maker Eli Lilly,

The pharmaceutical giant Eli Lilly was also a donor because of what it said was the Center for American Progress’s advocacy for patients’ rights — and just as the debate heated up in Washington over potential cuts to the Medicare program that covers Lilly’s most profitable drugs.

Although, for the record,

Neera Tanden, the president of the Center for American Progress, said in an interview that the group frequently takes positions that conflict with the corporate agendas of its donors, including companies like Eli Lilly. 

Also an important but somewhat less obvious linkage was described thus by the Times, 

 In addition, he earned $90,000 as a consultant to the HJW Foundation of West Chester, Pa, according to an aide working with him on the disclosure report he is preparing. HJW is a nonprofit group run by Hansjörg Wyss, a billionaire businessman and major contributor to the Center for American Progress.

What the Times did not say about Mr Wyss was that he is the former CEO of Synthes, a Swiss based medical device company, since merged into Johnson and Johnson   As we wrote in 2011,

 Synthes USA, the American branch of a Swiss based device company, first settled charges that it had been paying surgeons with company stock to use its products in its clinical trials in 2009 (see this post).  Then prosecutors alleged that these were not really rigorous trials. Instead, for marketing purposes, executives of Synthes subsidiary Norian persuaded surgeons to use its Norian XR product in a case series of spine surgery patients and then publish the results.  Three patients who received the product for this 'off-label' use died.  This scheme was alleged to have been directed by "person no. 7," whom journalists identified as the company CEO, Hansjorg Wyss (see post here.)   In an unusual move, the prosecutors indicted four company executives, who then pleaded guilty.  They did not take any further action against Wyss, who turns out to be one of the world's richest men (see post here).

However, at the time the former executives were sentenced, one of the executive's attorney's claimed,

Wyss was the undisputed leader of the company. 'He made some of the very critical decisions that put the trials on the ultimate pathway,' Gurney said. 'The culture of an organization is set at the top.'

Former Deputy White House Press Secretary to Global Strategy Group, Whose Clients Include Pfizer, Purdue Pharma, and WellPoint

As reported by the National Journal in December, 2013,

Bill Burton
Old gig: Deputy White House press secretary
New gig: Formed and ran Priorities USA Action, a super PAC that raked in more than $75 million during the 2012 campaign; recently joined the public affairs firm Global Strategy Group as a managing director. Clients include GE, Cisco, American Express, Comcast, and Pfizer.

Other health care clients include health insurance company Empire BCBS, pharmaceutical company Purdue Pharma, and for-profit health insurance company WellPoint

Former National Health Information Technology Coordinator to Get Real Health

As reported by Government HealthIT in February, 2014,

Three months after leaving the federal government, [former National Coordinator for Health Information Technology] Farzad Mostashari, MD, is joining the board of directors at the patient engagement company Get Real Health.

The big-thinking, bow-tied public health veteran is currently studying accountable care policies full-time at the Brookings Institution, and said he’s joining the Get Real Health board to help it '‘stay’ real as it innovates and serves patients and providers.'

The Rockville, Maryland-based company was founded in 2000, starting out as a connected health consulting outfit and then, after working with Microsoft’s HealthVault in 2007, launching its own health technology in 2012, the InstantPHR patient engagement platform.

From CareScience Inc to National Coordinator for Health Information Technology to Health Evolution Partners

The article about Dr Mostashari also mentioned in passing a more complicated set of transitions involving an earlier national coordinator for health care information technology.   

Mostashari is not the only former national coordinators to step into the health IT private sector after federal service. David Brailer, MD, the first appointee to the role of the national coordinator for health IT, is now running the San Francisco private equity firm Health Evolution Partners.

But in fact, according to his rather glowing Wikipedia entry, Dr Brailer also came from the commercial health care IT industry,

 In 1992, Brailer left academia and founded a company spun out of his Ph.D. thesis, inventing ways to measure health-care quality. This became CareScience Inc., a Philadelphia software firm that helped hospitals improve efficiency and prevent errors. Under Brailer, CareScience established the nation's first health care Application Service Provider (ASP). Brailer led the company through several financings, strategic partnerships, an initial public offering in 2000, and sale to global software firm Quovadx in 2003.

Then, in 2004,

Brailer was appointed as the first National Health Information Technology Coordinator, pursuant to an executive order by President George W. Bush on April 27, 2004, which called for widespread deployment of health information technology within 10 years.

According to his Health Evolution Partners biography, Dr Brailer is also now a member of the boards of directors of American Optical Services, CenseoHealth, Optimal Radiology, and Walgreen Co.

From Aide to Congressman Young to a Lobbying Firm with Health Care Clients Then to Congress

According to the Tampa Bay Times, yesterday Republican David Jolly won a special election to a congressional seat for Florida.  The article noted that Mr Jolly was "once an obscure aide to the late Republican U.S. Rep. C.W. Bill Young and then a Washington lobbyist,..."

His past work was described in more detail in a post on the Republic Report blog,

David Jolly, the Republican congressional candidate vying for the special election in Florida next week, has not only made a career out of lobbying. Records reviewed by Republic Report show that Jolly’s clients won millions of dollars in taxpayer earmarks from his old boss, the late Rep. C.W. 'Bill' Young (R-FL), an appropriator known for his lavish use of the earmarking process. 

Futhermore,

Two of the firms that hired Jolly as a lobbyist - BayCare Health Systems and Alakai Defense Systmes - won lucrative earmarks from Young while paying Jolly to influence the committee where Young was a senior member.

In 2009, BayCare Health Sytems retained Jolly and another former Young staffer named Douglas Gregory.  Later that year, Young secured a $1 million earmark for BayCare Health Systems for 'facilities and improvements.'

Summary

Note that the revolving door does not seem to discriminate according to political party or ideology.  The cases above involved both Republicans and Democrats. But the revolving door does discriminate against the not well connected, because it seems to provided preferred posts in the upper echelons of government for industry insiders, and preferred posts in the upper echelons of industry for government insiders. 

As we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?

Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.   

Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf) on page 115, there's this:

Patient Safety and Health IT Usability
Patient safety and usability continue to be a focus for
ONC. Working with federal partners AHRQ and FDA,
ONC will create the foundation for a patient
safety program that will be launched in FY 2014called “The Patient Safety Plan”. The Plan seeks
to ensure that health IT is safely designed and
implemented, medical staff are properly
informed and trained to use their health IT
systems, and a surveillance system is established
to monitor health IT related patient safety events
and ensure that unsafe conditions are corrected.

I believe the health IT industry now realizes some form of regulation is inevitable after, for example, revelations from medical malpractice insurers that a significant number of lawsuits involve the effects of health IT (see for instance my post "Malpractice Claims Analysis Confirms Risks in EHRs" at http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html).

I also believe that industry and its pundits have pushed for the most favorable regulation possible.  This involves pushing for regulation by agencies with the least agency independence as possible, as I bring out below. 

HHS along with its member branches FDA, AHRQ and ONC are executive departments of the US government  The legislation that governs the way such departments and agencies may propose and establish regulations is the Administrative Procedure Act of 1946 (http://en.wikipedia.org/wiki/Administrative_Procedure_Act).

First, it seems the executive branch is attempting to concentrate more power within itself over health IT through proposals like in the FY2014 HHS document.

I also point out that that HHS (and its offices such as ONC, FDA etc.) are federal executive departments.  http://en.wikipedia.org/wiki/United_States_federal_executive_departments. These are not entirely independent of presidential control:

"The heads of the federal executive departments, known as secretaries of their respective department, form the traditional Cabinet of the United States, an executive organ that serves at the disposal of the president and normally act as an advisory body to the presidency."

In other words, the leaders serve at the pleasure of the President.

This is as opposed to the executive department cousin, the federal independent agency, such as the NRC (Nuclear regulatory commission) and NTSB (national transportation safety board) that are independent agencies (http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government):

Independent agencies of the United States federal government are those agencies that exist outside of the federal executive departments (those headed by a Cabinet secretary). More specifically, the term may be used to describe agencies that, while constitutionally part of the executive branch, are independent of presidential control, usually because the president's power to dismiss the agency head or a member is limited.

It is no secret the administration is determined to push as rapid as possible rollout of health IT, come hell or high water, via HITECH, its coming penalties and other measures.  Its predecessor administration was a bit more genteel and circumspect in this regard.

It is clear to me that, in the current political environment, regulation by a federal executive agency is minimalist and will likely be politically ineffective, due to fear of its leadership of being dismissed if they upset the upper echelons.  

I note that Jeffrey Shuren, a physician and attorney, director of FDA CDRH already stated in 2010 that "health IT is a political hot potato" as a reason that FDA "has largely refrained from enforcing our regulatory requirements."  See my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs" at http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html for links to source.

I believe it would be better to place the authority for health IT regulation under the aegis of a federal independent agency, whether an existing one or one created for that purpose, so that its leaders are more independent of executive branch control.

-----

I predict that without meaningful regulation, this is where the health IT industry will find itself in a few years.

http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311

Reuters - Federal prosecutors are examining whether General Motors is criminally liable for failing to properly disclose problems with some of its vehicles that were linked to 13 deaths and led to a recall last month, according to a source familiar with the investigation.

The New York-based probe is in its early stages, and the source did not elaborate on the legal theory behind the potential criminal liability.

.. Federal investigators are reviewing information about how GM handled reports of problems with ignition switches that first came to light 10 years ago, according to the source.

The federal probe by the U.S. attorney in Manhattan adds to a growing list of U.S. authorities examining the recall, which GM announced in February. The National Highway Traffic Safety Administration (NHTSA) previously opened an investigation into whether GM reacted swiftly enough in its recall.

Earlier on Tuesday, Reuters reported that a U.S. Senate committee chairman is seeking a hearing on the issue. The U.S. House Energy and Commerce Committee also ordered GM and NHTSA to turn over information about GM's ignition switch problems.

The problems in some instances allowed the engine and other components, including front airbags, to turn off while the vehicle was traveling at high speed. More than 1.6 million older vehicles are affected.

The failure is believed to be caused when weight on the ignition key, road conditions or some other jarring event causes the ignition switch to move out of the "run" position, turning off the engine and most of the car's electrical components mid-drive, with sometimes catastrophic results.

GM has recommended that owners use only the ignition key with nothing else on the key ring.

.. The House committee examining the GM issue, led by Michigan Republican Fred Upton, gave the company and NHTSA until March 25 to turn over information about their responses to consumers' complaints about the problem.

The committee has asked GM officials to provide a briefing no later than March 18 on how GM has responded to reports of incidents since 2003 and its interaction with NHTSA since then on problems related to the ignition defect.

Upton led the 2000 investigation into Firestone tire failures on Ford Motor Co vehicles, resulting in the TREAD Act that requires automakers to report complaints of defects to the NHTSA.

That law also makes it a crime to intentionally mislead the agency about defects that lead to serious accidents.

... The person familiar with the criminal probe declined to discuss whether prosecutors were considering liability under the TREAD Act.

 In fact, there is no good reason the health IT sector has been excluded from such actions, through an unprecedented regulatory accommodation this single healthcare sector has enjoyed for decades - namely, that of no true regulation at all.
 

Sure, let's regulate a potentially proven dangerous healthcare technology, health IT (a glamor child of this administration) by a federal executive agency that serves "at the disposal" of the President ... instead of a federal independent agency, with ... uh ...better independence.  Great idea!

-- SS

3/12/14 Addendum:

Note this report of possible delays by the Department of Transportation on disclosure of GM ignition defects, by its National Highway Traffic Safety Administration branch, that caused fatalities and where disclosure could have (and finally now has) resulted in huge legal problems for GM.  GM is a company that was a centerpiece of the administration's economic interventions in recent years:

Did the Obama White House Protect GM?

Liz Peek
The Fiscal Times
March 12, 2014

http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM

Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry?

This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder.

The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  [Because they were afraid to? - ed.]  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times ...

Read the whole article.

The Department of Transportation is ... you guessed it ... a federal executive agency, not a federal independent agency.

-- SS

Liz Peek

The Fiscal Times

March 12, 2014

Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry?
This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder.
The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times.

- See more at: http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM#sthash.Ed9FH0ZD.dpuf

National Highway Traffic Safety Administrationsuspected of causing many deaths:  "Did the Obama White House Protect GM?", The Fiscal TimesMarch 12, 2014, http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM.Note that the Department of Transportation is ... you guessed it ... a federal executive department.

Did the Obama White House Protect GM?

Did the Obama White House Protect GM?

American Board of Internal Medicine Policy Condones Keeping Conflicts of Interest Secret

The latest complication of the CareFusion/ Dr Denham/ NQF/ Dr Cassel/ ABIM case was the revelation that the current president of the NQF, Dr Christine Cassel, after resigning her position on the board of directors of for-profit publicly held group purchasing organization Premier Inc, was found to have been on the board of for-profit privately held predecessor of Premier Inc since 2008 (see post here).  Before Dr Cassel was CEO of NQF, she had been the president and CEO of the American Board of Internal Medicine for 10 years.  So apparently she was on the board of the predecessor of Premier Inc for about five years while she was leading the ABIM.

This relationship appears to be as serious a conflict of interest for Dr Cassel in her previous role as leader of the ABIM as it was for her current role as leader of the NQF.  Since she had this conflict for so long as leader of the ABIM without public disclosure, it seems logical to ask whether she was a long-term violator of ABIM policy, and hence sort of a long-term rogue CEO?

To answer that, one needs to review the ABIM conflict of interest policy.

What Sort of Conflicts of Interest Does the ABIM Ban?

The official wording is:

It is the policy of the Board that Directors, Subspecialty Board and Committee members, consultants and other individuals involved in developing ABIM products will not be employed (as staff or as a consultant) at greater than fifty percent by a commercial entity, except in such instances where explicit exceptions to the policy have been made by the Board. Unless a compelling reason is presented for granting an exception, such individuals will be asked to resign their position of service to the Board.

Let us parse that a bit.  The policy applies to the leadership of the ABIM, Directors, Subspecialty Board and Committee members, consultants, and individuals involved in developing products, so it applies broadly.

However, conflicts are only banned when they exceed a 50% time commitment.  But the time commitments required by many sorts of relationships among physicians and health care corporations are ill-defined.  For example, in the initial public offering prospectus for Premier Inc, the public document that announced her membership on the new public company's board, there is no information about the time commitment required by this position.

Also, physicians can earn large amounts of money for relatively small investments of time.  For example, not only can members of boards of directors make hundreds of thousands of dollars for ill defined time commitments unlikely to approach 10% full time equivalent, but also, key opinion leaders acting as primarily marketing consultants can also earn hundreds of thousands of dollars for undocumented time commitments, and physicians can earn hundreds of thousands or millions of dollars from royalty payments from patent holdings that require no current work (look here for example).  So a physician could easily earn hundreds of thousands or millions of dollars from health care corporations without approaching a nominal 50% time commitment.  I suspect that this ban would apply to almost no one other than a full-time corporate employee.


Furthermore, the policy is not absolute.  Exceptions can be made for "compelling reasons," which are not further defined. 

This is thus a very weak element of the policy 

How are Conflicts of Interest that are Not Banned Managed?

The policy states,

Given that prohibition of all financial interest in commercial entities would excessively restrict the pool of eligible candidates for Board membership, the Board's policy to regulate conflicts of interest consists of disclosure, self-monitored (and Chair-overseen) abstention from participation in decision-making that relates to the conflict, and adjudication of potential conflicts of interest situations by the Conflict of Interest Committee of the Board of Directors.

Individuals (non-staff) involved in developing ABIM policy and products — ABIM Directors, Subspecialty Board Directors and Committee members, consultants, the President and relevant staff members will be requested at the time of their appointment and annually thereafter to execute a disclosure.

I would note that the rationale is highly questionable.  One often hears from apologists for conflicts of interest that all competent doctors are conflicted because health care corporations identify all the most expert doctors and hire them as speakers, consultants, etc (look here for example).  We have shown examples on this blog of some less than stellar individuals with extensive financial involvements with health care corporations.  For example, we have posted (here, here, and here) about physicians dubbed key opinion leaders by pharmaceutical companies who lacked board certification, had been subject to sanctions by state medical boards, had received warnings from the FDA, had lost hospital privileges, and had been convicted of crimes. On the other hand, there probably are quite a few smart, dedicated, expert physicians who eschew major financial involvement with health care corporations.

The policy goes on to state that for some individuals, the management would be recusal from participation in relevant decisions,

 Test Committees and other policy committees will be expected to discuss the conflict of interest policy, and to share relevant disclosures, with the expectation that committee members will disclose any significant actual or perceived conflicts and abstain from discussion where such conflicts exist. In the event that a potential conflict of interest situation arises about which explicit policy does not exist, the Conflict of Interest Committee of the Board will hear and judge the appeal.

Note that recusal may be inadequate management.  Committees tend to learn to get along with each other.  The views of committee members who have to recuse themselves may be well known, and may be supported by their fellow members even when their recused colleagues are not in the room.

Worse, the policy says nothing about whether higher level ABIM leaders even need to recuse themselves.  The recusal policy apparently only applies to committee members.  There seems to be no policy about management of conflict affecting

So the management of conflicts of interest proposed by the ABIM document seems to be rather minimalist.


Who Makes Decisions about ABIM Conflicts of Interest?

The policy states that disclosures will be made to,

• President and Chair of the Board;

• The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;

• The Conflict of Interest Committee members and Conflict of Interest Committee staff,

As noted above,

adjudication of potential conflicts of interest situations[would be] by the Conflict of Interest Committee of the Board of Directors.

However, again it is not clear whether they can adjudicate conflicts affecting anyone other than test and policy committee members.  Furthermore, whether anyone oversees conflicts affecting members of the Board of Directors is not clear.

Thus it is not clear who, if anyone, manages conflicts of interest affecting the top ABIM leaders, particularly the CEO and members of the board of trustees.  This aspect of the policy seems ambiguous.

How are Conflicts of Interest Publicly Disclosed?

The short answer is they are not.  The relevant wording is:

Information that is disclosed will be kept confidential except to the

• President and Chair of the Board;
• The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;
• The Conflict of Interest Committee members and Conflict of Interest Committee staff,

except as required for the purposes of continuing medical education.

Let me reiterate, conflicts of interest are NOT PUBLICLY DISCLOSED.  They are kept confidential, secret, hidden, opaque.  Only the insiders listed above may know about them.

We have been discussing the prevalence and severity of conflicts of interest affecting health care professionals and policy-makers, and institutional conflicts of interest affecting health care organizations for years.  Based on the principle that sunlight is the best disinfectant, many now agree that disclosure of these conflicts of interest is a necessity, although there is considerable discussion about whether the current movement to make conflicts of interest public will reduce their effects.  However, in my humble opinion, concealing conflicts of interest is inherently dishonest.   Yet that is the policy of the American Board of Internal Medicine.

Summary

So, while it appears that the former president and CEO of the ABIM had a severe conflict of interest generated by her membership on the board of directors of a privately held for-profit group purchasing organization, her failure to disclose it publicly did not violate ABIM policy.

The reason is that the ABIM policy on conflicts of interest appears to be extremely weak and ambiguous.  Worse, it condones keeping conflicts of interest secret, which to me appears inherently dishonest and unethical.

This is very disturbing given that the ABIM has great influence on medical practice and health policy, previously was regarded as prestigious and trustworthy, and has been expanding the scope of its activities to make it even more influential, e.g., by now requiring physicians to participate in periodic ABIM sanctioned or sponsored activities and take repeated ABIM exams to "maintain" their board certification.

In my humble opinion, if the ABIM wants to continue to be trusted as it has been in the past, it needs a wholesale revision of its conflict of interest policies, and meanwhile needs to completely make public in detail the conflicts of interest affecting individuals who lead it, make its policy, write its examinations, construct its educational and maintenance of certification activities, and produce its other "products."  The ABIM ought to consider suspending attempst to expand its influence, e.g., by intensifying its requirements for maintenance of certification, until it has disclosed all relevant conflicts and improved its conflict of interest policies.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. 

The Plot of the CareFusion/ Dr Denham/ NQF/ ABIM/ Dr Cassel Case Thickens Even More - Current NQF and Previous ABIM CEO Found to be Long-Term Premier Inc Board Member, Resigns from that Board

The plot of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case (as we previously entitled it)  just will not stop thickening.

Background

To summarize the events up to our last post on the subject: 
 -  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
 -  The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
-  The Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  The implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  The draft of the standard to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
-  The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor
-  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.
- Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure
-  In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.
-  Senator Charles Grassley is now investigating
-  Dr Christine Cassel, the CEO of the NQF, who had previous been the CEO of the American Board of Internal Medicine, was reported to be on the boards of directors of Kaiser Permanente Health Plans and Hospitals, a large non-profit health maintenance organization and hospital system, and Premier Inc, a for-profit hospital group purchasing organization.  Both these organizations could be affected by the standards set by the NQF, and possibly by the certification standards set by the ABIM.

A Change in Course at NQF

At the time these conflicts were disclosed by ProPublica, , an NQF spokesperson and the NQF board chairperson suggested that the organization was well aware of these relationships, did not believe they were serious conflicts of interest, but chose to manage them by having Dr Cassel recuse herself from specific activities that could be construed as conflicts of interest.  ProPublica quoted ethics experts who suggested that nearly all of Cr Cassel's activities at NQF could be involved in such conflicts, and hence such management would be inadequate.

Less than two weeks later, reports appeared that Dr Cassel will be resigning from the boards of Kaiser and Premier Inc.  As reported by Joe Carlson writing in Modern Healthcare,

In continuing fallout from a recent conflict-of-interest scandal, National Quality Forum President and CEO Dr Christine Cassel is stepping down from two outside board of directors jobs amid questions about whether they created conflicts of interest for her.

Cassel, 68, has worked on the board of directors at Kaiser Permanente Health Plane and Hospitals since 2003, and has held board jobs with healthcare supplier and consultant Premier and its predecessors since 2008. She told the National Quality Forum board of directors on Wednesday that she is resigning both roles because they had become a 'distraction' for the NQF. 

The story was also reported by ProPublica, and briefly with focus on California-based Kaiser, by the Los Angeles Times  and the San Francisco Business Times.

But the resignations were just to reduce "distraction," as per ProPublica,

The Quality Forum said in a statement today that Cassel's decision to sever ties was voluntary.

'Although serving on these boards provided her with direct knowledge of many current issues in health care, as well as practices of good governance, the issue of her board involvement had become a distraction,' the organization said in a prepared statement.

However,

[NQF board of trustees chair Helen]  Darling said she believed it was an asset to have Cassel aligned with such prominent organizations like Kaiser and Premier. 'It’s like saying you’ve got a Ph.D. from Harvard,' Darling said. 'This is something you’d be proud of.'

Ms Darling did not explain how the issue had become so distracting as to lead to a disavowal of something of which one should be so proud.

Modern Healthcare also reported that the National Quality Forum will re-review the 2010 standards that recommended use of a CareFusion product and were written by a committee that included Dr Denham, who was alleged by the US Department of Justice to have taken kickbacks from CareFusion.

What About the American Board of Internal Medicine?

Before coming to the NQF in 2013, Dr Cassel was the president and CEO of the American Board of Internal Medicine (per the NQF press release announcing her appointment). In our last post on the subject, I raised the question of whether Dr Cassel could have had a conflict of interest related to her stewardship over Premier Inc while she was running the ABIM.  However, at the time of the last post, there was nothing public about whether Dr Cassel had a role with Premier Inc or its predecessor organizations while she was the leader of the ABIM.  .

Now, according to Joe Carlson writing in Modern Healthcare, it seems that Dr Cassel had been on the board of the privately held but for profit predecessor of the publicly traded Premier Inc since 2008, overlapping at least five years of her leadership of ABIM.  Per that article, "Premier arranges for the purchases of products that could be affected by the NQF's patient-safety recommendations," and per the ProPublica article, Premier has an interest in what influences "practices adopted by medical providers across the country."  As  we wrote previously, the ABIM has a very substantial influence on health care.  Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc.  Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress.  So it would appear that Dr Cassel's long term stewardship of the predecessor of Premier Inc could have been just as important a conflict of interest for her as ABIM CEO as it appears to be for her as NQF CEO. 

Summary

This case increasingly demonstrates how pervasive is the web of conflicts of interest that is now draped over all of health care.  It also shows how important health care organizations seem to be lead by an overlapping, interconnected group of insiders.  The same names appear again and again amidst the top hierarchies.  The more ingrown the leadership of health care becomes, the more isolated it may be from the realities of health care for patients and health care professionals on the ground. 

Specifically re the extension of this case to the American Board of Internal Medicine, to update what I wrote previously, in my humble opinion the current ABIM leadership needs to consider that Dr Cassel, its previous long-term CEO, had a conflict of interest involving her membership of the board of the private for-profit predecessor to Premier Inc from 2008 to 2013.  Was this conflict disclosed to the ABIM board of trustees?  If so, was there an attempt at management, and why was it not publicly disclosed?  If the conflict was not disclosed to anyone, why not?  If what was done conforms to current ABIM policies on conflicts of interest, should these policies be strengthened?  If what was done did not conform to such policies, should their enforcement be strengthened?


To repeat,  Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."  [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.]  To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "EHR beneficence is not exactly as advertised" stories in one day.  It's hard to keep up:

After my earlier post today "EHRs: The Real Story" - Sobering assessment from Medical Economics, now there's this.

From the journal "Patient Safety & Quality Healthcare" (PSQH):

Malpractice Claims Analysis Confirms Risks in EHRs
Jan/Feb 2014

Article available at this link.

[Short header on several EHR-related care foul ups]

... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Although these systems promise to reduce costs and improve quality and safety, they’ve also ushered in unintended consequences as a result of human error, design flaws, and technology glitches.

Recognizing these emerging risks, CRICO—the patient safety and medical malpractice insurer for the Harvard medical community— is taking action. The Massachusetts-based company has expanded its proprietary coding system to capture EHR-related problems that have contributed to patient harm, and to guide the hospitals, physicians, and other providers it serves toward addressing vulnerabilities in their systems.

I had previously written about another Med Mal insurer who had noted these problems at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal.

... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.

The article notes this:

... Half of the 147 cases resulted in severe injury.

Patient deaths were a likely result, too, I note.

Note that this is just one insurer's data and assuming a good number of them were local to Massachusetts, could represent a significant percentage of the annual medical malpractice lawsuits in the state (Pennsylvania, a much larger state, has about 1500 med mal lawsuits filed annually). 

Note also that most cases of harm never make it to litigation due to the harsh economics of medical malpractice.

Numbers such as this will be going up as implementation, driven by HITECH incentives and penalties, accelerates in coming years.  This is especially true as medical centers and physician practices with far less clinical IT expertise and savvy than Harvard's become HIT users, and as the ability to capture such events increases.

The ECRI Institute "Deep Dive" study of health IT risk also speaks to a rise in numbers, with its finding of 171 health IT "events" in just 36 hospitals over 9 weeks voluntarily reported (i.e., just a fraction of the total), with 8 injuries and 3 possible deaths as a result (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

... The team asked its CRICO and Strategies members, “What vulnerabilities are you seeing? What are your risk managers worried about? What are your doctors complaining about?”

It used that feedback to draft a set of EHR-specific codes and then tested them in three datasets: CRICO (Harvard users) and two of Strategies’ larger clients, !e Doctors Company and Princeton Insurance. Based on those results, CRICO revised and approved 15 new EHR codes that went “live” in January 2013.

That means CRICO’s cadre of nurse coders can now identify EHR as a contributing factor to a malpractice claim, instead of using one of the less specific factors available in the past. [It's about time for a dose of transparency in the health IT sector - ed.]  And they can flag whether the problem involved user issues, system/technology issues, or both. “In some cases,” Sato points out, “the system design sets up humans to make errors.”

This should all be no surprise to any reader of this blog.  Read the whole article.

A more comprehensive list of "EHR harm modes" are at my posts "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide" (http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html) and "Cart Before the Horse, Part 3: AHRQ's Health IT Hazard Manager" (http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html).

The actual Hazards Manager report is at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf. It contains this summary of known hazards:

AHRQ's taxonomy of health IT hazards.  Click to enlarge.

-------------------

Having written on these issues since 1998 as a "health IT iconoclast" (http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf) and having been largely ignored by the cognoscenti, can I now say "I told you so?"

-- SS

"EHRs: The Real Story" - Sobering assessment from Medical Economics

From Medical Economics -

"EHRs: The Real Story",  pg. 18-27, Feb. 10, 2014, available here (PDF).

Full issue at http://medicaleconomics.modernmedicine.com/sites/default/files/images/MedicalEconomics/DigitalEdition/Medical-Economics-February-10-2014.pdf - it is large, 12 MB:

... "Despite the government’s bribe of nearly $27 billion to digitize patient records, nearly 70% of physicians say electronic health record (EHR) systems have not been worth it. It’s a sobering statistic backed by newly released data from marketing and research f rm MPI Group and Medical Economics that suggest nearly two-thirds of doctors would not purchase their current EHR system again because of poor functionality and high costs."

Here are other key findings from this national survey:

• 73% of the largest practices would not purchase their current EHR system. The data show that 66% of internal medicine specialists would not purchase their current system. About 60% of respondents in family medicine would also make another EHR choice.

• 67% of physicians dislike the functionality of their EHR systems.

• Nearly half of physicians believe the cost of these systems is too high.

• 45% of respondents say patient care is worse since implementing an EHR. Nearly 23% of internists say patient care is significantly worse.

• 65% of respondents say their EHR systems result in financial losses for the practice. About 43% of internists and other specialists/subspecialists outside of primary care characterized the losses as signifcant.

• About 69% of respondents said that coordination of care with hospitals has not improved.

• Nearly 38% of respondents doubt their system will be viable in five years.

• 74% of respondents believe their vendors will be in business over the next 5 years.

My own views are:

While some might dismiss such surveys as well as reports of harms as "anecdotes" (those same persons conflating scientific discovery with risk management, see http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html), I observe that such articles/surveys are increasing in frequency the past few years and are coming from reasonably capable observers - clinicians - .unlike, say, a Fox News survey of pedestrians on complex political matters.

Another physician survey is here:  http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html.

Here's an interesting ad hoc survey of nurses:  http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html.
.
This is not what the Medical Informatics pioneers intended, and is not due to physicians being Luddites (a topic I addressed at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).

In my opinion, organizations that have the expertise to change the current trajectory of this technology such as the American Medical Informatics Association (AMIA) needs to leave its tweed-jacket academic comfort zone and become more proactive - or perhaps I should say aggressive - in combating the industry status quo.  

The health IT industry trade associations such as HIMSS have no such qualms about aggressively and shamelessly pushing their version of EHR utopia, an agenda that has led to massive profits for the industry... but to clinician survey results such as above.  And to injured and dead patients.

-- SS

On the destruction of medicine as a profession: "Try bending a lawyer over a barrel"

From a physician colleague, a dedicated professional, reposted with redaction of locale with permission.

This speaks for itself.  I believe there are a great number of medical professionals who would speak out this way, if they did not fear retaliation (as does my colleague, hence anonymity) or if they were not suffering from the syndrome of clinician learned helplessness (http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html):

Scot,

Yesterday I spent some time in a family docs office in [redacted] who has been experiencing an EHR failure in his office. Naturally its messed up his work flow not to mention occupying hours on end of his ostensibly personal time. His reaction was mostly one of frustration.

In another situation, the ABMS is acquiring near dictatorial powers over physicians' livelihoods by essentially mandating an expensive, time consuming jumping through of hoops in the form of MOC requirements which may well evolve into MOL. Its a shakedown. Except for a few thousand members of AAPS that is seeking legal redress in Federal court, organized medicine is silent. Physicians who are undoubtedly frustrated just play the game in a grim resignation.

Where is the moral outrage? Where is the righteous anger? Another physician, a close friend of mine, feels exactly the same way. This healthcare system is poisoning our souls and is engaged in a full frontal assault against our ability to ply our trade (which we have invested so dearly in) as critical, free thinking human beings.

Extortion at its best. More ominously, we are being extinguished, not transformed,  as a profession. Remolded into subservient "providers". With little blow back. Can you even imagine any other profession allowing this to happen? Try bending a lawyer over a barrel. We are exploited blue collar workers without union representation. We are essentially working in a  meatpacking plant that Sinclair Lewis wrote of.

I am so tired and ashamed of being associated with a gutless group of people who call themselves physicians. I just had to get it off my chest.

If people remain indifferent to having their physicians bureaucratically overburdened and demoralized, the outcome will not be pretty in times of medical extremis.

-- SS

Incoming President of IOM Outed as Member of Boards of Alnylam Pharmaceuticals, Medtronic and Pepsico

We just discussed how the new CEO of the National Quality Forum was revealed to be a member of the board of directors of Premier Inc, and discussed the implications of this apparently intense conflict of interest. 

Now another new leader of an influential non-profit organization dedicated to improving health and health care has also been shown to have major conflicts of interest.

All Hail the New President of the Institute of Medicine

In 2010, we posted about a student protest of the salaries of some top administrators at Duke University, including then Chancellor of Health Affairs Dr Victor Dzau, at a time when the university was undergoing financial difficulties.  We pointed out that Dr Dzau's income was further increased by compensation received as a member of the boards of directors of multiple corporations, and further that serving as a highly paid steward of health care companies like Alnylam Pharmaceuticals, Genzyme, and Medtronic appeared to be a major conflict of interest.  .  

Last week Dr Victor Dzau was hailed as the new president of the Institute of Medicine.  The simple version, in Modern Healthcare:

 Duke University Health System President and CEO Dr. Victor Dzau was named president of the Institute of Medicine, succeeding the longtime president, Dr Harvey Fineberg, the National Academy of Sciences announced Wednesday.

Dzau, whose six-year term will begin July 1, has done research in the area of treatment for high blood pressure and congestive heart failure and pioneered the use of gene therapy for vascular disease, the institute said in announcing the selection. Dzau served on the IOM Council from 2008 through 2013, Fineberg said in a statement.

'As a physician-scientist and leader in academic medicine, Victor has consistently demonstrated inspirational leadership, innovative thinking and multifaceted achievement. Now, all of us at the IOM, both members and staff, will benefit more fully from his leadership,' said Fineberg, who has served as president of the institute for 12 years.

Conflicts of Interest Barely Noted

Neither this article, the official Institute of Medicine press release, nor articles in the few media outlets that initially covered this new appointment on 19-20 February, 2014,, including the Boston Globe and the Charlotte News-Observer, noted Dr Dzau's positions on the boards of directors of Alnylam Pharmaceuticals, device manufacturer Medtronic, and sugary soft drink maker Pepsico.

However, Forbes blogger Larry Husten, was the first to publicly report these memberships, drawing on our 2010  post  on Dr Dzau's conflicts of interest as Duke Chancellor for Health Affairs.

Then a blog post on Modern Healthcare by Steven Ross Johnson added some more detail,

IOM spokeswoman Jennifer Walsh said in an e-mail that Dzau initiated steps to resign from his corporate board positions before Wednesday's announcement and that he has committed to severing the ties by the time he begins his six-year term in July.

It did not mention why the IOM press release and the initial news stories did not mention Dr Dzau's board memberships nor his intention to resign from them.  The IOM spokeswoman apparently did not discuss why Dr Dzau was going to resign his board memberships now, while he had maintained them as a member of the IOM Council from 2008 to 2013.

Since then, later on 21 February, a single mainstream media article, in Bloomberg, did address Dr Dzau's new job, his corporate board memberships, and his planned resignations, with emphasis on his break from PepsiCo:

The newly appointed president of the Institute of Medicine, which advises government leaders and policymakers on health issues, plans to resign from several corporate boards in advance of taking his new job—including one that might have created a sticky situation.

Among the companies that Victor Dzau will sever ties with is PepsiCo (PEP), according to Jennifer Walsh, a spokeswoman for the IOM. 'Dr. Dzau had already decided to step down from corporate boards before he accepted the position,' she says.

For Dzau, who’s leaving his position as chief executive officer of the Duke University Health System to head up the IOM, the PepsiCo relationship might have been a problem: Several of the company’s products are among those blamed for contributing to the obesity epidemic in the U.S. The Purchase (N.Y.)-based company is best known for its Pepsi soft-drink line and snacks including Fritos and Cheetos.

The IOM, which has identified solving the nation’s weight problem as a top priority, endorsed the idea of a soda tax in a report detailing the 'staggering toll' of obesity. The agency estimates obesity-related illness in the U.S. costs $190 billion a year.

The Bloomberg article mentioned his memberships on the Alnylam and Medtronic boards mainly in passing.

The Rewards of Board Membership


The Modern Healthcare blog post provided a list of recent compensation Dr Dzau received from his board memberships.

According to Pepsico's 2013 proxy statement, Dzau deferred his retainer of $66,667 for the year ending Dec. 29, 2012, in lieu of 944 units of phantom stock, where cash is paid at a future date in an amount equal to the market value of stock shares. Dzau also serves on the boards of Alynylam Pharmaceuticals (he was paid $50,000 and received option awards of $89,000 in 2013) and medical devicemaker Medtronic (PDF) (he was paid $80,000 and received stock awards worth $140,000 in 2013).

It did not mention whether he currently owns any stock, or the equivalent, in any of these companies. 


However, the most recent Alnylam, Medtronic, and PepsiCo proxy statements show Dr Dzau's considerable stock holdings in these companies.

- According to the 2013 Alnylam Pharmaceuticals proxy statement, he currently owns the equivalent of 90,000 shares today worth $8,070,300 at the current price of $89.67.
- According to the 2013 Medtronic proxy statement, he currently owns 9636 stock options and 15,200 deferred stock units for total holdings of 25,156 share equivalents today worth $1,450,495 at a current price of $57.66.
-  According to the 2013 Pepsico proxy statement, Dr Dzau currently owns the equivalent of  36,173 shares of Pepsico stock. today worth $2,830,537 given a current price of $78.25. 

The Bloomberg article provided a somewhat lower estimate of the value his PepsiCo stock holdings based on an otherwise unidentified 2 December, 2013 filing with the US Securities and Exchange Commission.  It estimated the value of his deferred stock units in Medtronic based on an April, 2013 disclosure, but did not list the stock options which appeared in the July, 2013 proxy statement.  It noted his membership on the Alnylam board but did not mention that he held any shares or the equivalent in Alnylam stock.

I cannot find anything public about what, if anything, Dr Dzau plans to do with these not inconsiderable stock holdings in health care and health related corporations.  

Note that as we posted in 2010, in its last proxy statement before it was acquired by Sanofi, Genzyme declared that Dr Dzau owned the equivalent of 75,137shares as of 2009, which in 2010 were worth approximately $5.3 million.  I cannot tell what Dr Dzau did with these stock holdings after the merger.  


Thus while there may be some confusion about this current holdings and their exact value, it seems clear that Dr Dzau has become a multimillionaire by virtue of his holdings of stock or equivalent from the three companies, a drug company, and medical device company, and a company whose products have apparent public health implications, on whose boards he currently sits, and possibly by virtue of his holdings in another drug/ biotechnology company on whose board he previously sat.  .  

The Intensity of the Conflicts

The acuity of the conflicts presented were the President of the IOM to continue sitting on these boards was emphasized by this description of the influence wielded by the IOM written in an article in the Durham (NC) Herald-Sun,

 Under the congressional charter of the National Academy of Sciences, the Institute of Medicine is recognized as a primary source for independent, scientifically informed analysis and recommendations on health issues.

Even though Dr Dzau will apparently exit his board memberships before he becomes IOM President, the IOM  has been providing such analysis and recommendations under the supervision of a Council member who had fiduciary duties to the stockholders of two pharmaceutical companies a medical device company, and company that makes sugar-laden soft drinks and snack foods.  It will continue to provide such analysis and recommendations under the supervision of a President who became a multimillionaire by virtue of the stock holdings he acquired through his board positions.


In 2006 we first discussed a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.

Also, this case could be aggregated with that of Dr Cassel, the new CEO of the National Quality Forum (and former CEO of the American Board of Internal Medicine) who was found to be a member of the board of directors of Premier Inc, a for-profit hospital group purchasing organization.(see this post).  In my humble opinion, the issue here goes even beyond blatant conflicts of interest.  That top stewards of big for-profit health care corporations could simultaneously be  top leaders of influential non-profit organizations ostensibly dedicated to improving health and health care suggests that increasingly US health care is run by an insular group of insiders whose influence gets ever larger because of their collective power, not necessarily because of their dedication or ability to improvement of health care.  As reported by ProPublica about Dr Cassel's case,

Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.

'The insiders don’t see it,' Gibson said. 'It’s like a fish in water.'

How Would Dr Dzau Respond to Criticisms of the Companies He Directs, and How Would His Responses Reflect on the IOM?

Even if  Dr Dzau were to resign from all three corporate boards, and sells all his stock holdings in the three companies, as previous board member he was responsible for the stewardship of these four companies for years. Therefore it would not be unfair for someone to ask him to address any questionable actions of those companies that affected patients' and the public's health.

For example, as we have discussed here, Medtronic has been involved in a series of recent misadventures, including most recently a settlement between multiple hospitals and the Us Department of Justice of charges that they allowed themselves to be persuaded by executives of Medtronic subsidiary Kyphon to inflate their billings for patients who had a Kyphon device implanted (look here),  and a Senate report that Medtronic manipulated articles in the medical literature to market another of its products (look here).

But the awkward fact is that Dr Dzau, as a board member of Medtronic, can be seen to be a steward of that corporation, and hence responsible for the its overall direction.  Even if he were no longer a board member, he cannot erase his responsibility for Medtronic activities that occurred on his watch.  Thus, Dr Dzau could easily find herself in the uncomfortable situation of having to defend and justify questionable past behavior by Medtronic while simultaneously wearing the hat of President of the IOM.  How that would play out is not obvious.

Summary

To date, the case of Dr Dzau as incoming president of the IOM and current board member of Alnylam Pharmaceuticals, Medtronic and Pepsico has received little attention, and therefore no ethics expert has gotten a chance to speak up in public about it, as they have about the case of Dr Cassel, the NQF, and Premier Inc.  So I will have to step in.

As I have said before,  Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."  [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.]  To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.

The IOM ought to consider
-  Immediately disclosing conflicts of interest affecting all its members, staff, and leadership in a very clear and accessible manner
-  Beginning a gradual but complete phase out of such conflicts

Otherwise, we all ought to be concerned that the leadership of medicine and health care is increasingly in the hands of a small group of insiders, interchangeable executives who simultaneously or sequentially lead multiple organizations, and are likely to become more comfortable with the fellow members of this interlocking leadership than with ordinary health care professionals, patients and the public.