Wednesday, May 06, 2015

Politico: Electronic record errors growing issue in lawsuits

The indefatigable Arthur Allen of has authored a nice piece on the issue of EHRs being a cause of medical malpractice, with resultant litigation.  I was a contributor:

Electronic record errors growing issue in lawsuits
By Arthur Allen
5/4/15 6:40 AM EDT

Medical errors that can be traced to the automation of the U.S. health care system are increasingly an issue in medical malpractice lawsuits.

Some of the doctors, attorneys and health IT experts involved in the litigation fear that safety and data integrity problems could undercut the benefits of electronic health records unless HHS and Congress address them aggressively.

I already believe the benefits of EHR technology have been severely undercut - if not destroyed - by the unbelievably poor quality, user experience and incompetent implementations presented by most commercial health IT software today.

I even have a dead mother to offer as evidence, due to an ED EHR's lack of fundamental and crucial confirmation dialogs and notification messages to team members.  These computer science-101 level deficiencies permitted a triage nurse's failure to successfully click a heart medication for continuation to propagate through several days of ICU/floor hospitalization unnoticed.  Gross overconfidence in computer output and cavalier attitudes in the ICU about med reconciliation sealed the deal, where, recognizing something seemed amiss with the meds list vs. the history of arrhythmia, the ICU doctor did nothing except leave a question in the chart about it, resulting in catastrophe.

“This is kind of like the car industry in Detroit in 1965,” says physician Michael Victoroff, a liability expert and a critic of the federal program encouraging providers to adopt EHRs. “We’re making gigantic, horrendous, unsafe machines with no seat belts, and they are selling like hot cakes. But there’s no Ralph Nader saying, ‘Really?’”

There are, actually, but an "Unsafe at any MHz" has not yet been written and taken seriously by the public about EHRs.  The industry has been too in control of the narrative for that to happen.

According to a review by The Doctors Company, the largest physician-owned U.S. medical malpractice insurer, EHR issues were involved in only 1 percent of a sample of lawsuits concluded from 2007 through 2013. But that finding could be deceptive since it takes five or six years to close a suit, and during that period the numbers of such cases grew rapidly as electronic health records become more pervasive in hospitals and physician offices. The pace of these cases doubled from 2013 to early 2014.

At the linked report at the med mal insurer "The Doctor's Company" noted:

... Shortly after electronic health records (EHRs) began to be widely adopted, The Doctors Company and other medical professional liability insurers became aware of their potential liability risks. We anticipated that EHRs would become a contributing factor in medical liability claims. Due to the three- to four-year lag time between an adverse event and a claim being filed, however, EHR-related claims have only recently begun to appear. In 2013, we began coding closed claims using 15 EHR contributing factor codes (eight for system factors and seven for user factors) developed by CRICO Strategies for its Comprehensive Risk Intelligence Tool (CRIT).

In 2013, The Doctors Company closed 28 claims in which the EHR was a contributing factor, and we closed another 26 claims in the first two quarters of 2014. During a pilot study to evaluate CRICO’s EHR codes, 43 additional claims closed by The Doctors Company were identified (22 from 2012, 19 from 2011, and 2 from 2007–2010).

What is not stated is the fact that many EHR-related harms are not recognized as such; many injured patients do not sue, and many who want to cannot do so due to the expense and time involved for plaintiff's attorneys (I have heard the figure that perhaps 5% do make it to suit).  Along with the time lag noted, these figures are another Red Flag, as are the ECRI Deep Dive harm figures, representing what is likely just the "tip of the iceberg."

(See "Peering Underneath the Iceberg's Water Level" at and "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at

Back to Politico:

The lawsuits allege a broad range of mistakes and information gaps — typos that lead to medication errors; voice-recognition software that drops key words; doctors’ reliance on old or incorrect records; and nurses’ misinterpretation of drop-down menus, with errors inserted as a result in reports on patient status.

In addition, discrepancies between what doctors and nurses see on their computer screens and the printouts of electronic records that plaintiffs bring to court are leading some judges and juries to discredit provider testimony and hand out big awards. In one case, a patient in septic shock had suffered gangrene and a severe skin rash, but computer records read “skin normal.” They also showed repeated physician interviews with the patient — when she was comatose.

I can verify both of these issues personally, from my legal work - not to mention outright electronic record tampering.

... While the percentage of EHR-related cases is still low, “this is going to become a bigger and bigger issue,” said David Troxel, medical director of The Doctors Company. “I get more calls from frustrated, angry doctors about their EHRs than any other subject.”

Doctors may be following my advice (see end of my post at where I wrote:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

  • ... Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)
Back to Politico:

The industry “takes very seriously the need to enhance the well-documented ability of EHRs to increase patient safety,” an association spokesperson said. “It also recognizes the importance of looking for opportunities to identify and reduce any potential risks associated with development and use of EHRs. All these efforts are essential to the goal of learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways.”

This is pure B.S. and spin.  There is no "well-documented ability of EHRs to increase patient safety", just a number of methodologically flawed/biased studies (like this one,, a lot of pro-HIT rhetoric, and a lot of harms data that the industry ignored for many years.

The statement also ignores what the domain expert end users - physicians and nurses - themselves are saying, see "Accenture - Fewer U.S. Doctors Believe IT Improves Health Outcomes (April 2015)" at

Why, one should ask as well, should an industry that's been around for decades only now be "learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways?"  

I see that statement as an industry self-condemnation of years of cavalier IT practice. 

... But providers and health care systems are eventually going to start suing vendors, analysts said, in part because software companies are viewed as having deep pockets. “It’s only a matter of time before a company like athenahealth or Allscripts or Epic or Cerner gets sued,” said Klein.

Plaintiffs’ attorneys are already eyeing such cases, according to Scot Silverstein, a Drexel University health IT expert and internist who is suing a hospital over a lapse in care of his mother that Silverstein claims was caused by poor EHR implementation. Silverstein and two plaintiff’s attorneys met with Rep. Matthew Cartwright (D-Pa.) and other lawmakers in November to plead for more government regulation of EHRs.

I was actually more direct with the author of the article, Mr. Allen.  I said that the sellers of these systems deserved to be sued - that they had earned it through slovenly practices in thought and application enabled by the extraordinary regulatory accommodations afforded to and protected by the industry since its inception (i.e., no regulation) - when system flaws result in patient harm. 

... Some recent studies show that EHRs do make hospitals safer. But the data isn’t conclusive, said William Marella, executive director of the ECRI Institute Patient Safety Organization. Last year, ECRI convened a partnership of EHR vendors, safety experts, academics and medical groups to share and analyze health IT problems ... EHR safety issues are frequently misdiagnosed — and thus under-diagnosed — by providers, according to ECRI’s Marella. “They say, ‘wrong site surgery,’ or ‘drug error,’ which can make it hard to ferret out the cases where IT is responsible.”

It is absurd and disingenuous to speak of 'safety improvements' when the true harms rates are admittedly unknown (see "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" ( for more on that issue.

... In about 200 EHR-related legal cases that the liability firm CRICO analyzed, the glitches rarely led directly to patient harm, said Dana Siegal, the company’s director of patient safety services. But she added, “We’re seeing failures to communicate or providers acting on inaccurate information that was driven in part by an EHR issue.”

This brings up another issue.  Computers don't pull triggers and the mayhem they cause doesn't usually immediately kill people.  My mother, for example, survived the initial EHR-led assault on her life, though her survival required emergency reversal of anticoagulation in the face of critical carotid stenosis that had already caused a TIA, emergency craniotomy (brain surgery), and other risky interventions.  She died a year later of complications of her injuries.  Her case would not be likely to be counted as an "EHR-related death" in any statistics (if it was reported at all).  This "time delay" would likely cause any statistics on EHR-related deaths to be understated on their face.

... While the effect of EHRs on malpractice suits is still modest, many analysts worry about the overall uncertainty concerning information in such systems. Confusing or inaccurate records, if they proliferate, not only cast doubt on a doctor in court but could taint clinical research that draws on these large pools of data.

Bravo to Arthur Allen for pointing out that clinical research that draws on garbage, uncontrolled data will turn out garbage.  See my paper "The Syndrome of Inappropriate Overconfidence in Computing" at for more on that issue where I observed:

... This increasing confidence in EHR data to perform far more complex tasks than postmarketing surveillance of a single drug is of great concern. Prompt detection of adverse drug events (ADEs) from single drugs, using aggregated EHR data, is within the realm of possibility. Detection of relatively more nebulous (i.e., compared to major ADE) “outcomes differences” between two or more drugs or treatments via EHR data—such as, did treatment A lower blood pressure more than drug B, or did drug C lessen depression more than drug D—rises to the level of “grand overconfidence in computing” and perhaps “grand folly.”

To accomplish this task with reasonable scientific certainty from aggregated EHR data originating from different vendor systems, input by myriad people of different backgrounds, with differing interpretations of terminologies (students/residents/attending
MDs/RNs etc), under different pressures and motivators (time limits, cognitive overload from poor HIT user interfaces, reimbursement maximization, and so forth), seems improbable.

What levels of statistical validity could arise from such studies? Could they even approach the level deemed “acceptable” in good science?We do not know, although I suspect a “garbage in, garbage out” (GIGO) phenomenon, leading to studies whose results are more likely related to chance than to solid reality.

Back to Politico:
A recent report by the HHS Office of Inspector General said the department has failed to assure that EHR data are secure and accurate. Many hospitals have unsecured audit trails—meaning that information in the record could be altered without detection, it said.

This ability - to alter records - has been admitted under oath by EHR systems administrators in cases in which I have been an advisor to the Plaintiffs' attorney - and had the questions asked.  Hospitals have possession and control of easily-alterable information (far easier than paper) that is the only evidence of potential misadventures - a major conflict of interest.

... “There’s really no one with a vested interest in the integrity of the record besides you, the patient,” said Reed Gelzer, a physician and health IT expert.

Yes, but getting it can cost thousands of dollars.  I paid about one thousand dollars for a few reams of printed EHRs, and this is not uncommon.

... Concerns led the Institute of Medicine in 2011 to propose the creation of a dedicated IT safety center with the power to investigate EHR risks. ONC has since settled on a center that would have no investigatory power but would provide a safe environment in which real-life problems could be analyzed and solutions developed.

In other words, ONC has settled on a joke, on tension management.

The safety center is a “critical priority right now for ensuring the transformation from a world of paper to a world of electronics and connectedness,” said Patricia McGaffigan, COO and a senior vice president at the National Patient Safety Foundation.

Yes, a powerless, industry-friendly "safety center" is a priority for good reason.  Not to sound mean but, if the wife, child, parent of one of the proponents of a milquetoast "Safety Center" suffers EHR-related injury and dies a painful and lingering death as a result, they will get little sympathy from me.   They've certainly tempted the Gods.

I will leave the final word to physician Michael Victoroff:

“The vendors are very right that if they had true product liability they wouldn’t make these things,” he said.

To which I say to the Information Technology vendors, if you can't take the heat (of accountability in medicine), then get the hell out of our medical kitchen.

-- SS

Another day, another EHR outage: MEDSTAR EHR goes dark for days

At my March 2, 2015 post "Rideout Hospital, California: CEO Pinocchio on quality of patient care during hospital computer crash" ( I highlighted a stunning example of when the light shone through the corporate B.S. about health IT outages, thanks to a letter to the editor by a family member of an affected patient:

Letter: Re: Rideout Hospital computer problems 

Friday, February 27, 2015 

I am writing in regard to comments made by the CEO of Rideout Hospital regarding its recent computer crash. 

He said quality of care for patients had not been compromised during this incident. He is lying.

My spouse went to Rideout almost two weeks ago and had a Lexiscan of her heart when the computer system went down. The hospital doctor released her and assured her that if anything were wrong, the radiology department would spot it and she would inform us.

Here it is two weeks later and now they are saying because of the computer problem the entire test didn't get to her cardiologist until today. They think she may have had a minor heart attack and needs further cardiac intervention.

 Is this the new "open and improved" truths we are getting from this hospital? Rideout CEO Robert Chason misinformed us all. 

I am sure my spouse, who has fallen through the cracks during this inexcusable lapse in Rideout's technical policies, is not the only patient suffering similar situations. 

Shame on Chason for minimizing the effects of this catastrophe at our local hospital. 

Edward Ferreira 
Yuba City

I am aware of another major EHR outage via


MEDSTAR EHR GOES DARK FOR DAYS: MedStar’s outpatient clinics in the D.C. and Baltimore area lost access to their EHRs Monday and Tuesday when the GE Centricity EHR system crashed. The system went offline for scheduled maintenance on Friday and had come back on Monday when it suffered a “severe” malfunction, according to an email from Medstar management that was shared with Morning eHealth.

“All of a sudden the screens lit up with a giant text warning telling us to log off immediately,” a doctor said. “They kept saying it would be back up in an hour, but when I left work Tuesday night it was still down.”

This doctor told us that the outage was “disruptive and liberating at the same time. I wrote prescriptions on a pad for two days instead of clicking 13 times to send an e-script. And I got to talk to my patients much more than I usually do.

But of course we didn’t have access to any notes or medication history, and that was problematic.” MedStar notified clinicians in the email that any information entered in the EHR after Friday was lost.

I do not know if corporate issued the standard "patient safety was not compromised" line, but can almost predict it was uttered somewhere along the line.

MedStar is a big healthcare system.  An outage for several days at its outpatient clinics is disruptive and will lead to harms in the short term, but also in the long term, that cannot be effectively tallied, due to lost information. 

That includes information put on backup paper that fails to get entered when an EHR goes back up, as well as outright computer data loss as occurred here.

Note the doctor's comments about the "liberating" aspect of being freed from health IT.  He/she could actually practice medicine, not computer babysitting.

How many harms will come of this "major malfunction?"  There is no way to know.  However, hospitals cannot have it both ways.  If these systems are touted as improving safety, then safety is affected when they are down and emergency measures are put into place, resulting in chaos; and certainly when information simply goes to the "bit bucket."

The answer?  Either far more redundancy, or far less reliance on "paperless" systems.

There also needs to be mandatory reporting of EHR outages and root cause analysis so the incidence and the reasons can be studied, at the very least.

-- SS

MBA-holding Informatics Fellow's Portfolio: Revolutionizing Healthcare Through Plagiarism

I highlighted the MBA culture at least once before on this site, on April 16, 2010 at "Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'",

In that post, I noted MBA candidates/Cerner employees happily conspiring in a paper at Duke's Fuqua School of Business towards combination in restraint of trade through "recommending that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. "

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

The paper was highlighted at  professor David Ridley's page "Duke University Fuqua School of Business: Past Papers" - that is, until a few days after my blog post went up and he was informed of it.   You can see cached copies of the paper and page at the post at link above.

Today, I've had another experience with an MBA holder who has decided to enter the field of Medical Informatics.

I received an unsolicited Cc: of an email, sent by a professional in my field I do not know at a university in Australia.  The email was directed at a postdoctoral fellow at a U.S. medical informatics program in the Midwest, advising the fellow that his 'Portfolio' brag page page was plagiarized directly almost verbatim from a personal essay I'd written ca. 1999 and now archived at my current Drexel site at, and that plagiarism was bad for informatics careers:

Date: Tue, May 5, 2015 10:28 pm
To: [Name of recipient MBA-holding informatics fellow redacted - ed.]

I was disappointed to find the following three paragraphs on the homepage of your site ([URL redacted] - ed.)

"It became apparent to me and many informatics professionals that significant confusion and misconceptions exist in hospitals, industry, and the world at large about what medical informatics is, and what experts in medical informatics do (and are able to do if given the opportunity). Also, there is confusion as to what medical informatics is not.

"The available quantity of information in most subject areas ("domains") has grown rapidly in recent decades. Issues about information and its use have become quite complex, and the issues themselves have undergone scientific study. Informatics is information science. In other words, informatics is a scientific discipline that studies information and its use.

"Both theoretical and practical issues are studied. Examples of theoretical issues include terminology, semantics (term meaning), term relationships, and information mapping (translation). Practical issues include information capture, indexing, retrieval, interpretation, and dissemination. Medical informatics, an informatics subspecialty, is the scholarly study of these information issues in the domain of biomedicine."

This text is an almost perfect copy of the introduction to Scott Silverstein’s page (

Plagiarism has no place in Medical Informatics, and could harm your career. I would appreciate it if you could rewrite or remove this content on your site

Best Regards 

[Professor name redacted - ed.]

There was other copied material after these paragraphs as well; almost the entire page was my words and ideas.  The page shamelessly concluded with this:

Shamelessly copied from

I do not know how the Australian professor detected the plagiarism, if he had involvement with the fellow, or the context of the interaction.

This fellow had an MBA and the title of his "portfolio" page was about his passion for 'revolutionizing healthcare.'

It's clear he thought his stealing my words and ideas would never be noticed. In other words, exploiting my creativity for his own gain and image-enhancement was fine.

Obviously in our connected world, plagiarism is not a good idea. Perhaps not so obvious are the predatory values of the MBA degree and the damaging effects on all our healthcare when such individuals 'revolutionize' it.

I sent a demand for the material's immediate removal along with a polite suggestion of unpleasantness if he does not comply.

I am not naming the postdoc due to having bigger fish to fry.

-- SS

Update 5/6/2015: 

The fellow has removed about 3/4 of my material from the webpage in question, but a passage remains verbatim.

I've sent another request backed by a screenshot and link to my material, and a rather more direct consequence of failure of complete removal.

Between the IT invasion of health IT and the MBA invasion, perhaps patients need to hire fulltime medical advocates for everything more serious then getting a boil lanced.

-- SS

Second Order Generic Management: Lobbyist Named CEO of American Hospital Association

A long time ago, in a universe far, far away, hospitals had relatively small administrations, usually lead by a older physician or nurse who served as executive director or superintendent.  Leading a hospital was seen as a calling, not a means to become rich.  With the rise of generic management, hospital management grew, and became dominated by generic managers who were trained as managers, not as health care professionals.

So if hospitals are now usually lead by generic managers, it should be no surprise that hospital organizations are lead by generic managers.  So it should be no surprise that the current CEO of the American Hospital Association, Richard J. Umbdenstock, was formerly " executive vice president of Providence Health & Services and president and chief executive officer of the former Providence Services, Spokane, Washington." (Look here.)

What should be a surprise, however, is what was just reported in Modern Healthcare,

The American Hospital Association has chosen Richard Pollack, its longtime lead lobbyist, to succeed Richard Umbdenstock as CEO. Hospital leaders say Pollack is the right pick, even though he never led a hospital or health system.

Pollack, 59, has been with the AHA for more than three decades and has served as the group's executive vice president for advocacy and public policy since 1991. He will take over the top post in September, the AHA announced Monday during its annual meeting in Washington.

Pollack has developed a sterling reputation for pressing the hospital group's agenda on Capitol Hill and beyond. He's played an integral role in top healthcare policy discussions in recent years, including passage of the Affordable Care Act.

Chip Kahn, president of the Federation of American Hospitals, which represents investor-owned hospitals, called Pollack a 'wise Washington hand.'

In addition,

John Rother, president of the nonpartisan National Coalition on Health Care, noted that it's an unusual pick in the sense that Pollack has not overseen a major hospital system. Before joining the AHA, Pollack served as a lobbyist for the American Nurses Association. The Brooklyn native started his professional career in 1977 as a legislative assistant for Rep. David Obey (D-Wis.)

So, the incoming American Hospital Association CEO is not a doctor or a nurse.  He has not had any known direct experience in patient care.  He has no training or experience in public health or biomedical sciences.  Furthermore, he has no direct experience working, even just as a manager, in a hospital or any organization that provides patient care or for the public health.

His entire experience is in Washington, DC, first as a legislative staffer, and then - not to put too fine a point on it - as a lobbyist.

This would make sense if he were going to lead a lobbying firm.  However, the AHA says:

In summer 1995, after regional policy board (RPB) review, the Board of Trustees approved vision and mission statements:

Vision: The AHA vision is of a society of healthy communities, where all individuals reach their highest potential for health.

Mission: To advance the health of individuals and communities. The AHA leads, represents and serves hospitals, health systems and other related organizations that are accountable to the community and committed to health improvement.

So now we have hospitals largely run by generic managers.  Furthermore, hospital associations, whose members are largely represented by generic managers, now may be run by lobbyists, people even more removed from actual health care.  Hence, perhaps too archly, I suggest that Mr Pollack is the first known example of a second order generic manager.


 In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician.

The managers who first took over health care may have had some health care background.  Now it seems that health care managers are decreasingly likely to have any health care background, and increasingly likely to be from the world of finance.  Meanwhile, for a long time, business schools seem to have been teaching managers that they have a God given right to manage every organization and every aspect of society, regardless how little they know about what the particular context, business, calling, etc involves.  Presumably this is based on a faith or ideology that modern management tools are universally applicable and nigh onto supernatural in their powers.  Of course, there is not much evidence to support this, especially in health care.

We have discussed other examples of bizarre proclamations by generic managers and their supporters that seem to corroborate their belief in such divine powers.  Most recently, there was the multimillionaire hospital system CEO who proclaimed new artificial intelligence technology could replace doctors in short order (look here).   Top hospital managers are regularly lauded as "brilliant," or "extraordinary," often in terms of their managerial skills (look here), but at times because of their supposed ownership of all aspects of patient care, e.g., (look here)

They literally are on call 24/7, 365 days a year and they are running an institution where lives are at stake....

As noted above, if the new generic managers work in offices that are physically, intellectually and spiritually distant from the real world of health care, a lobbyist running a hospital association would be at best distant even from the management suite.

It is way past time for health care professionals to take back health care from generic managers.  True health care reform would restore leadership by people who understand the health care context, uphold health professionals' values, are willing to be held accountable, and put patients' and the public's health ahead of self-interest.

Sunday, May 03, 2015

Innovations form the Safra Center Ending iCorruption Conference

I had the pleasure of attending the Ending iCorruption Conference, the capstone conference for the Edmond J Safra Research Lab on Institutional Corruption, held at the Harvard Law School on May 1-2, 2015.  The conference included much material relevant to health care corruption and related topics, and provided some innovative approaches that could be used to address these issues.  I list these below, with citations or links when available.  At some point in the future, all conference proceedings should be available on video from the Safra Center.

Uncovering Data on Conflicts of Interest

Unearth: Using PubMed to Uncover Conflicts of Interest Affecting Clinical Research

Unearth is a browser extension now available for Google Chrome, and soon to become available for other browsers, e.g., Firefox.  It works on PubMed searches, scraping funding and conflict of interest data from the body of articles and adding them to abstracts.  We have often discussed such conflicts of interest, and their relationship to manipulation of clinical research.  Unearth could make such conflicts more salient, making it easier to discriminate unconflicted from conflicted research.  (See this post on the Bill of Health blog.)  This application was developed during the Safra Center Hacking iCorruption Event.

Open Think Tanks: Uncovering Think Tank Funding

Think tanks often publish findings on and make recommendations about health care.  However, think tanks are often opaque, and any institutional conflicts of interest they have may not be easily apparent.  Open Think Tanks currently shows donations from government entities outside the US to US based think tanks.  Enhancements to include various kinds of private donations are likely in the future. This application was also developed during the Hacking iCorruption Event.

Finding Unconflicted Academics

As we have discussed, the majority of medical academics have conflicts of interest, which may affect their research, teaching and patient care.  Yet these conflicts are not always disclosed.  Furthermore, finding experts without conflicts is not easy.  ProfessorCert is a website that allows academics who have no conflicts of interest to register as such.  The website was developed by the Academic Independence Project

Improving Integrity

Putting Consumers in the FDA and Other Regulatory Agencies

We have frequently discussed regulatory capture, how government health care regulatory agencies, like the US Food and Drug Administration (FDA),  often seem to end up more concerned about the financial health of those they are supposed to regulate than patients' and the public's health.   Harvard Prof Daniel Carpenter, collaborator in Safra Center research,  talked about the problem of  "cultural capture" of regulatory agencies, in which the regulators' thinking is influenced by outside vested interests.  He proposed that regulatory agencies need to put consumers, or presumably other stakeholders like unconflicted health care professionals, "into the room."  

Putting Ethicists in the C- Suite

We have frequently criticized the leadership of hospitals and hospital systems.  In particular, we have discussed instances in which these leaders seem to have gone directly against the mission of their own organizations, which we termed mission hostile management. Safra Lab Network Fellow James Corbett, now Senior Vice President for Centura Health, proposed that ethicists who also understand the language of finance and management be present among the top leadership of hospital systems.  

Licensing Executives

As noted above, a major theme of the Health Care Renewal blog is the shortcomings of the leadership of large health care organizations.  Top leaders often have business training, but may be ill-informed about health care, and ignorant or unsupportive of  or even hostile to its values.  Wellesley College Professor Emerita Ann Congleton's 2014 article in the Journal of Business Ethics, entitled Beyond business ethics: an agenda for the trustworthy teachers and practitioners of business, proposed requiring that corporate executives, including executives of health care corporations, be licensed in order to lead their organizations.  I proposed licensing of leaders of large health care organizations as early as 2008 (here).    

Pharmaceutical Research Uninfluenced by the Pharmaceutical Industry

Because clinical research meant to evaluate drugs or devices sponsored by  manufacturers of the relevant products has shown to be frequently manipulated, or even suppressed, many people have suggested banning such sponsorship and direct influence of such manufacturers.  (For example, see the book and blog, both entitled "Hooked," written by Dr Howard Brody, and see Health Care Renewal blog posts, e.g., here.)
Safra Center Network Fellow and Rowan University Professor Donald Light's book in press, Good Pharma, basically offers proof of the concept that high quality clinical research on pharmaceuticals can be accomplished without industry money or influence, albeit in Italy, at the Mario Negri Institute


The project on institutional corruption at the Safra Center produced a burst of innovation meant to address this pervasive project, and thus provided much of value to those who want to challenge health care corruption.  I hope this innovation will turn out to be truly disruptive.  It is regretful that this project has come to an end.  We can only hope others pick up the banner.  

Monday, April 27, 2015

Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015

Pollyanna statements about healthcare IT such as the following are still appearing, and are growing increasingly tiresome.  They are, at best, demonstrations of people with a fiduciary duty to have known better making fools of themselves.

Pollyanna: someone who thinks good things will always happen and finds something good in everything (Merriam-Webster,


... Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, that shady conspiracies are operating -- make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers are easily affected by fear mongering.  (Mark Leavitt, former head CCHIT,

"The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety."  (David Blumenthal, former head of ONC at HHS,


"We don't think there's a great deal of data to substantiate that there are major safety problems with the majority of electronic health records systems in use today," said Charlie Jarvis, executive committee vice chair of the EHR Assn., a trade group that represents 46 organizations that supply most of the EMR systems implemented in medical practices. "These products are safe, dependable, time-tested and display a lot of the safety features we think are necessary to prevent problems going forward." (Charles Jarvis, erstwhile NextGen VP and holder of prestigious (and mysterious) "American Medical Informatics Certification for Health Information Technology",

The most recent example highlighted on this blog is:

As Minnesota’s health commissioner, I work to improve the health of all Minnesotans. As a physician, I’m dedicated to providing the best care possible to patients. Secure electronic health records help achieve both goals by enhancing the safety, effectiveness, and efficiency of our health care system. With that in mind, I have been concerned to see some recent pushback on Minnesota’s requirement that all health care providers use electronic health records (EHR) by 2015 ... All Minnesota patients, whether they visit a small clinic, need mental health treatment, or receive care from multiple providers, stand to benefit from EHRs and the improved care coordination they make possible. (Minnesota's Heath Commissioner Dr. Edward Ehlinger,

Here is the tragic reality.

Recommended for reading, and for feeding to the press and to our elected officials:

Primer on health IT realities in 2015:


(1)  "Five biases of new technologies", Trisha Greenhalgh.  Br J Gen Pract. 2013 Aug; 63(613): 425

The most dangerous of these biases is the "subjunctivisation bias".  It results in clinical disruption, mishaps, injury and death:

Subjunctivisation bias: Much of the policy rhetoric on new technologies rests not on what they have been shown to achieve in practice but on optimistic guesses about what they would, could, or may achieve if their ongoing development goes as planned; if the technologies are implemented as intended; and in the absence of technical, regulatory or operational barriers.4 This is what Dourish and Bell call the ‘proximate future’: a time, just around the corner, of ‘calm computing’ when all technologies will be plug-and-play and glitch-free.

(I point out a related bias - that of the hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.  See

(2)  ECRI Institute Deep Dive Study on Health IT risks (2012)

171 IT mishaps sufficient to cause harm reported voluntarily by 36 hospitals in 9 weeks; 8 injuries; mishaps likely contributed to 3 deaths as well.  Projected to a nationwide annual figure, the result is likely many thousands of times greater (see

(3)  Letter to ONC from 37 Medical Societies (January 2015)

This letter speaks for itself on exceptionally well-justified clinician dissatisfaction and alarm at the risks and disruptions posed by this technology in its current form and with present roles (e.g., the experimental use of clinicians as cheap data entry clerks).
(4)  Joint Commission Sentinel Events Alert on Health IT (March 2015)

Late, but better than never.  Most of what's in this alert has appeared on this blog since 2004.   Footnote 1 (ECRI Institute PSO Deep Dive, the report linked above) is somewhat bizarrely used as a justification of the statement "EHRs have demonstrated the ability to reduce adverse events."  I do also note at the linked these statements:

  • Poorly designed or implemented health IT can contribute to patient harm
  • Health IT-related patient safety events can go undetected
  • As health IT adoption becomes more widespread, the potential for health IT-related patient harm may increase
These could have come directly from my writings dating back over a decade here.  (Perhaps they did.)

(5)  Accenture - Fewer U.S. Doctors Believe It Improves Health Outcomes (April 2015)           

This survey also speaks for itself.  A less formal nurses' survey is here:

(6)  U.S. Centers for Medicare & Medicaid Services (CMS)
FOIA response:  "We do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  (But let us spend hundreds of billions of dollars and put patients at risk to find out...)

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives.  [Click to enlarge.]

In conclusion:

Next time you encounter pollyanna/head-in-the-sand statements about health IT that ignore the risks, throw this primer the way of the authors and audience of such statements.

-- SS

Sunday, April 26, 2015

More Barbarians at the Gates: Private Equity Puts Primary Care in Play

There are still some idealistic physicians who enter primary care practice as a calling.

The usual informal definition of primary care is care which is continuous, coordinated, comprehensive and compassionate.  The official definition used by the American Academy of Family Physicians (AAFP) is:

Primary care is that care provided by physicians specifically trained for and skilled in comprehensive first contact and continuing care for persons with any undiagnosed sign, symptom, or health concern (the 'undifferentiated' patient) not limited by problem origin (biological, behavioral, or social), organ system, or diagnosis.

Primary care includes health promotion, disease prevention, health maintenance, counseling, patient education, diagnosis and treatment of acute and chronic illnesses in a variety of health care settings (e.g., office, inpatient, critical care, long-term care, home care, day care, etc.). Primary care is performed and managed by a personal physician often collaborating with other health professionals, and utilizing consultation or referral as appropriate.Primary care provides patient advocacy in the health care system to accomplish cost-effective care by coordination of health care services. Primary care promotes effective communication with patients and encourages the role of the patient as a partner in health care.

Private Equity Firms are Buying Out Primary Care Practices

However, an article this week in Modern Healthcare described how primary care in the US is getting a rude surprise.  Apparently, primary care practices are now "in play," (using the terminology for the classic 1987 movie Wall Street, in which Gordon Gekko declared that greed is good).

The argument was that there is

a small but growing number of investments that private-equity firms are making in primary-care physician practices that are ahead of the curve in offering new care delivery and payment models. Investors see an opportunity in being early participants in value-based care, even as the business case is still unclear given mixed results in Medicare's payment and delivery reform demonstrations so far.

But the niche is well-suited for private-equity firms, which feed on uncertainty, said Todd Spaanstra, a partner at Crowe Horwath, an accounting and consulting firm. 

This is not about quality of care, it is about the idea that business people think that "value-based care" and "risk-based contracting" are the current rages, and so there is money to be made investing in entities that seem to fit in with these fashions.

said Slava Girzhel, managing director at KeyBanc Capital Markets. 'There's a lot of discussion about private-equity investing in risk-based models, and I do think we'll see more of that.'

Continuous, coordinated, comprehensive and compassionate care may suffer when the time horizons are not that long, and the owners of the practice are ultimately looking to sell it. 

The long-term opportunity for private-equity firms is the ability to sell these managed-care-savvy medical groups to insurers or health systems, which may pay a premium for the care-coordination expertise and data analytics these practices offer.


The typical private-equity investment timetable is short—about five years. At that point, the firm would probably look to sell the practice, ideally to an insurance company or a health system, said Dan Hosler, a principal at private-equity firm Sterling Partners.

Furthermore, why private equity may be interested in primary care now, continuing interest will depend on the numbers, not on the benefits to patients

'This is an area where there are winners and losers,' said Dr. Andrei Gonzales, director for value-based reimbursement initiatives at McKesson Health Solutions. 'It's everyone trying to get a slice of the pie that's getting smaller.'
What Happens When the Barbarians are at the Gate

Conspicuously absent from this article was discussion of aspects of the private equity modus operandi which are even more at odds with primary care values than the short time horizon noted above.  We previously warned about the perils of private equity employing physicians (look here.)  The main points were:

-  Private equity is just the new name for leveraged buyout firms (the type of firm described the book, Barbarians at the Gate.)

-  Therefore, when they buy out firms (e.g., the primary care practices discussed above), they use borrowed money.

-  But they leverage in two senses.  Once firms are bought, the private equity owners makes the firms take out further loans, and the money from them may go back to the owners, usually in the form of a special dividend, to pay down the debt originally incurred by the private equity owners.  This leaves the bought out firms heavily in debt, but frees the private equity firm from its original debt.  If the firm is eventually sold, the new buyers take over the debt.  In a worst case scenario, however, the bought out firm goes bankrupt, the private equity's firm stock in it becomes worthless, but the private equity firm need not be responsible for its financial obligations.

-  If the private equity firm desires more money while it still owns the acquired firm, it may sell parts of it off.

-  To make the finances of the acquired firm look more attractive to the next buyer, the private equity firms often undertakes short term cost cutting measures that may involve layoffs, increased workload on remaining workers, etc.

Other dark aspects of private equity are discussed on the Naked Capitalism blog here.


Primary care physicians thinking about selling their practices to private equity ought to think at least twice before doing so, assuming the physicians are serious about upholding the values of primary care.  Private equity firms are in it for the money, and in the relatively short term.  Private equity firms are unlikely to care about the mission of primary distinct from the ability of primary care practices to make the firms richer.  Therefore, practices owned by private equity may well not provide the best possible care for their patients.  In any case, the physicians working for such practices may be answering to owners who are very explicitly only in it for the money.  They will have become corporate physicians, possibly in the most pessimistic sense of the term.

In general, Dr Arnold Relman reminded us that physicians used to shun the commercial practice of medicine (look here).  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be hostile to their professional values, and who are subject to perverse incentives that support such hostility, including the potential for huge executive compensation.  It is not clear why physicians seem to be willing to sign contracts that underline their new subservience to their corporate overlords, and likely trap them within confidentiality clauses that make blowing the whistle likely to lead to extreme unpleasantness.

Things are likely to be even worse for corporate physicians who are employed by firms owned by private equity. Because of the way private equity operates, primary care practices owned by such firms are liable to be very unstable.  At best, they are liable to be sold to totally new owners in a relatively short time frame, and those owners are likely to be those who will pay the highest price, not necessarily those who will provide the best stewardship for the practices.

Furthermore, primary care practices owned by private equity are likely to end up heavily indebted and subject to strict cost cutting measures that may decrease care quality, decrease access, increase patients' out of pocket costs, and demoralize providers.  Practices acquired by private equity may be broken up and sold as separate pieces.  Should the debt be too high, and the cost cutting not be sufficient, such practices could end up bankrupt and possible completely defunct. 

Do not say I did not warn you.

Physicians need to realize that to fulfill their oaths to put patients first, they have to reduce the influence of rich and powerful organizations with other agendas, like health care corporations, and especially corporations owned by private equity.  The metastasis of private equity into primary care should make us all rethink the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

ADDENDUM (28 April, 2015) - This post was re-published on the Naked Capitalism blog.  

Saturday, April 25, 2015

Open Letter to Minnesota's Heath Commissioner Dr. Edward Ehlinger on ill-informed health IT puff piece

Minnesota's Heath Commissioner Dr. Edward Ehlinger penned a puff piece on EHRs entitled "Electronic health records advance quality care for all Minnesotans" (Minn Post, 4/23/15,

It constains all the usual baloney (being kind here) about this technology:

It starts with this:

As Minnesota’s health commissioner, I work to improve the health of all Minnesotans. As a physician, I’m dedicated to providing the best care possible to patients. Secure electronic health records help achieve both goals by enhancing the safety, effectiveness, and efficiency of our health care system. With that in mind, I have been concerned to see some recent pushback on Minnesota’s requirement that all health care providers use electronic health records (EHR) by 2015 ... All Minnesota patients, whether they visit a small clinic, need mental health treatment, or receive care from multiple providers, stand to benefit from EHRs and the improved care coordination they make possible.

"Pushback", he writes?

The implication seems clear - 'fear mongering' by Luddite clinicians is responsible.  See my March 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at on that antediluvian, tired old issue.

Note also the terminology "stand to benefit" - a typical weasel phrase just in case things don't work out as intended.

Not mentioned are the harms.

Rather than plow through yet another puff piece by someone either misinformed or just way behind the current medical literature on this experimental technology, I provide the letter I wrote to Dr. Ehlinger and several other Minnesota cabinet members, including Commissioner Kevin Lindsey of the Dept. of Human Rights, Commissioner Lucinda Jesson of the Dept. of Human Services, and Chair Adam Duininck, Chair of the Metropolitan Council:

The letter:

From: Silverstein,Scot
Sent: Saturday, April 25, 2015 7:00 AM
Subject: "Electronic health records advance quality care for all Minnesotans" - really?
Congratulations Dr. Ehlinger.  With your puff piece "Electronic health records advance quality care for all Minnesotans" ( you just flunked my introductory course in Medical Informatics.

Kindly refrain from writing on subjects about which your knowledge clearly lags common knowledge in healthcare information technology (IT).

You must not know about the following, although you should have known, or should have made it your business to know, about these at the very least:

  1. ECRI Institute Deep Dive Study on Health IT risks (2012)
  2. Letter to ONC from 37 Medical Societies (January 2015)
  3. Joint Commission Sentinel Events Alert on Health IT (March 2015)
  4. Accenture - Despite Increased Use of Electronic Medical Records, Fewer U.S. Doctors Believe It Improves Health Outcomes (April 2015)           

I don't mean to sound insulting, but it is earned on your part.  My mother is deceased in 2011 as a result of an EHR error.

When did you plan on informing the citizens of your state about the risks of bad health IT?

Not giving your citizens opportunity for informed consent regarding the use of these medical devices in their care seems a violation of human rights.  The most impacted are the disadvantaged, who go to organizations with lesser budgets to make the IT work safely, I add.


Scot Silverstein


Scot M. Silverstein, MD

Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present)
Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)
Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)
Drexel University
College of Computing and Informatics
(formerly College of Information Science and Technology)
3141 Chestnut St., Philadelphia, PA 19104-2875

I did not mention the horrible track record of breaches (e.g., as retrieved by query link  Close calls, maiming and death is enough for one letter.

It is truly unnerving to see a physician responsible for the heath of the citizens of an entire state so seriously misinformed.

-- SS

Sunday, April 19, 2015

On Generic Management in Health Care: Hospital Chief Information Officers (CIOs) Say Patient Engagement is All About ... Themselves?

To laugh or to cry? - now it seems that hospital CIOs think they "own" patient engagement. 

An article in Medscape summarized a presentation at the Healthcare Information and Management Systems Society (HIMSS) Annual meeting that provided a surprising insight into how some hospital managers think.  The survey focused on the concept of patient engagement:

In separate surveys, researchers polled a national sample of 125 chief information officers, 359 primary care physicians, and 2567 patients who visited their doctor in the previous 90 days. Questions centered on beliefs about engagement, the perceived roles of the stakeholders, and barriers.

The patients seemed to have a sensible idea about their own engagement,

From the patient perspective, getting help from a provider they trust is most important, said Mazi Rasulnia, PhD, from M Consulting LLC, who is cofounder of Pack Health, a patient-activation company in Birmingham, Alabama.

What they expect most, according to the survey, is a provider who listens to them and helps them understand treatment options before they make a decision.

'Patients want questions answered around the specificity of their own health, not just what generally happens with 'patients like you' or from a population standpoint,' Dr Rasulnia said.

'What they don't really care for or expect is for providers to 'give me a website so I can access my medical information'.' That, and asking patients about their personal life, ranked lowest on patients' lists of expectations.

They want providers to help them navigate not only their disease, but also the health system. Providing access is important, but that alone won't help patients engage, he explained.

The article did not provide much information about the physicians' responses, but did suggest

When physicians talk about patient engagement, they tend to think in terms of the doctor–patient relationship,...

So in general, the doctors and patients were on the same page, but

doctors believe patients need to take more responsibility for their outcomes, and patients say they can't because their doctors, who are responsible for engaging them, don't spend enough time with them.

Setting aside the causes and approaches to the problem of insufficient time during patient encounters, the chief information officers (CIOs), had a radically different idea,

when healthcare executives talk about the patient engagement envisioned under the Affordable Care Act, they think in terms of transactions,...


 Chief information officers believe they are responsible because patient engagement involves technology,...


The chief information officers surveyed 'clearly saw themselves as the owners of patient engagement,' said Lorren Pettit, MBA, vice president of market research for HIMSS Analytics, who reported on the systems perspective.

When chief information officers were asked who is most accountable for patient engagement in their organizations, 46.4% said they were, but 14.4% thought nurses were accountable for patient engagement, not physicians or patients.

Comment - on the Hubris of Generic Managers

I have to assume that the article, presentation, or the survey were hopelessly garbled. If not, what on earth were the chief information officers thinking?

Chief information officers think they are the "owners of patient engagement?"  While "patient engagement" does not seem to be a well-defined term (look here), and seems like an example of bureaucrat speak or politically correctness, it surely seems to be related to communication between patients and health care professionals.  It surely does not seem to be directly about information technology. At best, the health care information technology CIOs manage could support patient engagement.    Furthermore, the explanation apparently offered by the CIOs, that patient engagement involves technology, is not helpful because at this time, all of medicine and health care to some extent "involves technology."

So why would CIOs claim to "own" patient engagement?  Maybe they are simply clueless about what patient engagement really involves.  CIOs rarely interact with patients.  Most CIOs have no direct health care experience, and are not trained as doctors or nurses.  For example, a recent list of "100 Hospital and Health System CIOs to Know" included only 10 with health professional degrees (seven MDs, three RNs).

Why then, not simply admit that the issue is out of their area of expertise, rather than claiming "ownership."  My best guess is this is the bravado, or arrogance of generic managers.

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician.

The managers who first took over health care may have had some health care background.  Now it seems that health care managers are decreasingly likely to have any health care background, and increasingly likely to be from the world of finance.  Meanwhile, for a long time, business schools and the like seem to have teaching managers that they have a God given right to manage every organization and every aspect of society, regardless how little they know about what the particular context, business, calling, etc involves.  Presumably this is based on a faith or ideology that modern management tools are universally applicable and nigh onto supernatural in their powers.  Of course, there is not much evidence to support this, especially in health care.

We have discussed other examples of bizarre proclamations by generic managers and their supporters that seem to corroborate their belief in such divine powers.  Most recently, there was the multimillionaire hospital system CEO who proclaimed new artificial intelligence technology could replace doctors in short order (look here).   Top hospital managers are regularly lauded as "brilliant," or "extraordinary," often in terms of their managerial skills (look here), but at times because of their supposed ownership of all aspects of patient care, e.g., (look here)

They literally are on call 24/7, 365 days a year and they are running an institution where lives are at stake....

If hospital CEOs, who spend lots of time in offices, at meetings, and raising money, really see themselves as perpetually on call, and directly responsible for patients' lives, then maybe it's not surprising that their CIOs think they own patient engagment.

So in summary this latest survey shows the continued hubris of the generic manager, and hence their continued unsuitability to run health care organizations.  It is time for health care professionals to take back health care from generic managers.  True health care reform would restore leadership by people who understand the health care context, uphold health professionals' values, are willing to be held accountable, and put patients' and the public's health ahead of self-interest. 

ADDENDUM (20 April, 2015) - This post was republished on Naked Capitalism

Monday, April 13, 2015

"God Damn the Pusher Man" - Especially when Enabled by the FDA Revolving Door

Who is watching the watchers?  A story this week involving "speed" like drugs added to "dietary supplements" suggests how far the once respected US Food and Drug Administration has fallen.

An Amphetamine-Like Drug Spiking "Nutritional Supplements"

The story began with a paper by Cohen and colleagues published a relatively obscure medical journal, and then picked up by the news media.(1)  The main points of the article were:

BMPEA (beta-methylphenylethylamine) is a compound first synthesized in the 1930s as a "potential replacement" for amphetamines.  Animal tests revealed amphetamine-like properties.  The compound was never tested on humans, and never marketed.


BMPEA remained known only as a research chemical until early 2013 when the FDA identified BMPEA in multiple supplements labelled as containing ‘Acacia rigidula’, even though the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas.


More than two years after the FDA's discovery, the FDA has yet to warn consumers about the presence of the amphetamine isomer in supplements.

So Cohen et al undertook to identify "nutritional supplements" said to contain acacia rigidula and test them for BMPEA.  They found 21 such supplements, all of which tested positive. The authors then recommended,

that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements. Consumers should be advised to avoid all supplements labelled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight loss and sports supplements.
Note that while the power of the FDA to regulate "nutritional supplements" is limited by a 1994 law, Cohen and colleagues wrote that it

is tasked with identifying and removing mislabelled, adulterated, and dangerous dietary supplements from the marketplace.

Since BMPEA is apparently not found in nature, and was not sold prior to 1994, putting BMPEA in a "dietary supplement" appears to be adulteration. 

The Risks of BMPEA in Nutritional Supplements

The study was then picked up by the media.  In the Los Angeles Times, Pieter Cohen, the lead author of the journal article,

said that while the effects of BMPEA are unknown, the compound is potentially dangerous. He said the FDA's failure to act is 'completely inexcusable.'

Furthermore, in a CBS report,

BMPEA has not been tested in humans, but led to increased blood pressure in cats and dogs.

'These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death,' Cohen said.

The point is that while it has never been tested fully on humans, there is every reason to suspect that BMPEA acts very similarly to amphetamine, colloquially called "speed."  Amphetamines, as we discussed here, have dangerous side effects, including severe blood pressure elevations, and increased risks of stroke, myocardial infarction (heart attack), and other cardiac events.  The drugs also have a high potential for abuse. 

Why Did the FDA Do Nothing? 

Despite the likely riskiness of BMPEA, the FDA did nothing when it found it in numerous dietary supplements in 2013, and has not indicated that it will do anything now.  According to the LA Times,

FDA spokeswoman Juli Putnam acknowledged that the agency published research on the occurrence of BMPEA in Acacia rigidula supplements in 2013.

'While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers,' she said.

In a Consumers Report item, Dr Cohen responded to that,

'It’s mind boggling,' said Pieter Cohen, M.D., the Harvard physician who is the lead author of the new study, published online in the journal Drug Testing and Analysis. 'The companies think they have complete impunity. They assume the FDA will do nothing about it. And they’re right.'

A post in the NY Times Well blog reiterated, 

Under federal law, dietary supplements — with some exceptions — can contain only ingredients that are part of the food supply or that were already on the market before 1994. Dr. Cohen said that BMPEA has never been sold as a food or supplement, and as a result any product that contains it is considered adulterated, which would give the F.D.A. the authority to send warning letters to companies that add it to their supplements.

Yet while the FDA had authority to do something, it did nothing.

Was the Revolving Door the Reason?

Back in 2014, we posted about two transitions through the revolving door by the FDA official in charge of the regulation of nutritional supplements.  We reproduce the relevant section of the post below:

This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"

Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.

The article had previously identified Dr Fabricant as

the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.


The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.

While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not then question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

In 2014, the Times drew no conclusions about Mr Fabricant's career trajectory.  However, this time

But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and lobbying group.

Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.’s supplement division also comes from the trade group.

'To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,' said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.

Also, the new Well blog post noted 

Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. She is now the acting director of the agency’s supplement division. Dr. Cohen, who is also an internist at the Cambridge Health Alliance, said he repeatedly wrote to Dr. Welch asking what the agency was going to do about BMPEA, and that she did not respond.

Dr. Welch declined repeated requests for interviews. In a statement, Juli Putnam, an F.D.A. spokeswoman, said that the agency 'has found that hiring experienced leaders with diverse backgrounds in public health, industry, academia, and science enriches the professional environment and leads to the best health policy outcomes for the American public.'

Before joining the F.D.A., Dr. Welch was the vice president of scientific and regulatory affairs at the Natural Products Association, where she was a staunch defender of the supplement industry. When JAMA, a leading medical journal, raised concerns in a 2011 editorial that the federal law allowed the supplements industry to police itself, Dr. Welch responded that the industry had 'an excellent safety record.'

'The industry itself supports and has implemented strong self-regulatory mechanisms,' she said in an industry news release at the time.


To summarize, from 2011 to now, the leadership of the part of the FDA that is supposed to regulate dietary supplements was dominated by former top executives of the Natural Products Association, the trade organization for dietary supplement manufacturers.  In 2013, FDA scientists found that multiple dietary supplements contained BMPEA, a compound closely related to amphetamines, and hence potentially dangerous and addictive, although it had never been tested on or previously used by humans.  Although the FDA had authority to do something about this apparent adulteration of these products, it so far had done nothing.  Thus it appears that the currently legal revolving door that allows government regulation to be run by people who come directly from the industries that government is supposed to regulate could be responsible for exposing people to dangerous, addictive drugs.

Remember, BMPEA is a first cousin of amphetamine, amphetamine is "speed," and as the drug epidemics of the 1960s and 1970s showed us, "speed kills."  So a plausible argument is that the revolving door, as relevant to FDA, has enabled manufacturers of nutritional supplements to become the "pusher man," a la the Steppenwolf sound track of Easy Rider,

As we noted here, some experts consider the revolving door per se to be corruption, not merely conflict of interest.  The current case plausibly suggests not only that the revolving door is corrupt, but that when applied to health care can pose dangers to patients, not merely danger to government finances, government ethics, and the integrity of representative democracy.  Nonetheless, up to now, a few people have decried the revolving door (and very occasionally in health care), but nothing has been done about it.   

So it is surprising that today (13 April, 2015), the New York Times published an editorial inspired by the BMPEA case, which concluded

consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.

As a minimum, that would be a good start.  Unfortunately, even a NY Times editorial hardly guarantees action.  At least, however, the problem of the revolving door as a danger to patients has gotten a little less anechoic.

As we last wrote, the continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large.

ADDENDUM (20 April, 2015) - This post was republished on Naked Capitalism


1.  Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamins isomer whose efficacy and safety in humans has never been studied, beta-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.  Drug Testing Analysis 2015; DOI: 10.1002/dta.1793  Link here.