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

Charlie Jarvis David Blumenthal Edward Ehlinger healthcare IT difficulties healthcare IT myths healthcare IT pollyanna Mark Leavitt proximate future subjunctivisation bias Trisha Greenhalgh

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

Unknown 4/27/2015 Komentar

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, http://www.merriam-webster.com/dictionary/pollyanna)

Examples:

... 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, http://www.ihealthbeat.org/perspectives/2009/health-it-under-arra-its-not-the-money-its-the-message.aspx)

and:

"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, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)

and:

"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", http://hcrenewal.blogspot.com/2011/11/two-opposing-views-of-ehr-1.html)

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, http://www.minnpost.com/community-voices/2015/04/electronic-health-records-advance-quality-care-all-minnesotans.)

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
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3722815/

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 http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html.)

(2)  ECRI Institute Deep Dive Study on Health IT risks (2012)
http://www.healthit.gov/facas/sites/faca/files/STF_Deep_Dive_Health_Information_Technology_2014-06-13.pdf

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 http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

(3)  Letter to ONC from 37 Medical Societies (January 2015)      
http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf

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)   
http://www.jointcommission.org/assets/1/18/SEA_54.pdf

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 http://www.jointcommission.org/safe_health_it.aspx 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)                    
http://www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves#.VT5bmpOTqUk

This survey also speaks for itself.  A less formal nurses' survey is here:  http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html

(6)  U.S. Centers for Medicare & Medicaid Services (CMS)
https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj9SR15pp-ucgkJH_vLA51JhLCkVDonFUTN-eqy5H4q35QbjlLCVfSVafNsao6hpg04nn7DP8yaes9rYl-npuIRspFX7fjOKXjhSMCCRbEwwgqfeOxTPvbY8JoSno2VSknCtCZrppXoClwo/s1600/CMS_Letter.jpg

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

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

corporate physician primary care private equity You heard it here first

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

Unknown 4/26/2015 Komentar

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.

Also,

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.

Summary

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.  

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

Chair Adam Duininck Commissioner Kevin Lindsey Commissioner Lucinda Jesson Edward Ehlinger healthcare IT myths healthcare IT risk Minnesota Heath Commissioner minnpost.com

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

Unknown 4/25/2015 Komentar

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, http://www.minnpost.com/community-voices/2015/04/electronic-health-records-advance-quality-care-all-minnesotans).

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 http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html 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
To: health.commissioner@state.mn.us
Cc: info.mdhr@state.mn.us; dhs.info@state.mn.us; public.info@metc.state.mn.us
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" (http://www.minnpost.com/community-voices/2015/04/electronic-health-records-advance-quality-care-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) http://www.healthit.gov/facas/sites/faca/files/STF_Deep_Dive_Health_Information_Technology_2014-06-13.pdf
2. Letter to ONC from 37 Medical Societies (January 2015)       http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf
3. Joint Commission Sentinel Events Alert on Health IT (March 2015)    http://www.jointcommission.org/assets/1/18/SEA_54.pdf
4. Accenture - Despite Increased Use of Electronic Medical Records, Fewer U.S. Doctors Believe It Improves Health Outcomes (April 2015)                     www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves

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.

Sincerely,

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 http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy).  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

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

generic management generic managers HIMSS information technology

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

Unknown 4/20/2015 Komentar

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,...

Furthermore,

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

Also,

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. 

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

amphetamines conflicts of interest FDA health care corruption revolving doors You heard it here first

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

Unknown 4/13/2015 Komentar

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.

But,

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.

However,

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.

But,

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.

Summary

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. 


Reference

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.

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