Showing posts with label amphetamines. Show all posts
Showing posts with label amphetamines. Show all posts

Wednesday, 23 December 2015

How Managerialists Turned Housestaff Training into a Zero-Sum Game: the Continuing Saga of the FIRST and iCompare Studies

How Managerialists Turned Housestaff Training into a Zero-Sum Game: the Continuing Saga of the FIRST and iCompare Studies

A ongoing controversy about two controlled trials (FIRST and iCompare) meant to test the bizarre hypothesis that sleep depriving medical housestaff (that is, physicians in training) would improve health care provided new evidence that academic medicine has been captured by managerialists.  

Background: the Controversy about the FIRST and iCompare Housestaff Sleep Deprivation Trials

In early December, 2015 we posted about two clinical trials, FIRST and iCompare, designed to test the hypothesis that  increasing housestaff sleep deprivation would improve care continuity, and thus somehow improve housestaff their performance and their patients' outcomes.  Not only did the studies' hypothesis seem strange, but the studies seemed to violate fundamental rules of research ethics.  Study investigators proceeded without obtaining formal informed consent from their house staff or patient research subjects, and did not allow any research subjects to opt out without penalty (e.g., house staff would have to quit their programs and find new ones to opt out).  Finally, after Public Citizen and the American Medical Student Association (AMSA) complained about the studies, study defenders based their arguments on logical fallacies.

Why would distinguished medical educators behave so strangely?  I hypothesized that medical educators could not imagine a way to improve care continuity without worsening trainees' sleep deprivation because all logical methods to do so would cost money.  However, the managerialist executives to whom medical educators are now beholden shrink from increasing costs, other than their and their cronies' own compensation.

Two Psychiatric Residents Write about the Zero-Sum Game of Housestaff Training

Of course, the controversy, and particularly the complaints from AMSA and Public Citizen have been largely anechoic.  But recently, the Washington Post published a commentary by two psychiatric residents on these issues.  The authors, Jeffrey Clark and David Harari, confirmed many of my concerns about the sleep deprivation trials.  They personally verified that the studies were done without informed consent from the research subjects.

The two of us and our patients were not provided informed consent before being enrolled in the iCompare trial.

The also confirmed that the trial investigators assumed they were working in a zero-sum framework.

We already know that extended shifts are dangerous. While many people rightfully suspect that current duty-hour limits aren’t improving outcomes, these studies err in assuming that the dangers of sleep deprivation must be traded for the dangers of shared patient care. Such a zero-sum framework won’t help us improve patient care or ensure the well-being of resident physicians.

To elaborate, the big problem with the duty hour restrictions is that while limiting the consecutive hours interns were supposed to work, this was not accompanied by any diminution of the total workload of housestaff at any one institution.

The standards published in 2011 by the Accreditation Council for Graduate Medical Education still allow hospitals to put residents through blistering 80-hour work weeks, while setting maximum shift lengths of only 16 hours for interns and 24 hours for more senior residents. Interns simply work shorter but more-frequent shifts. Doctors hand off patients to each other more regularly but without the training needed to manage these transitions effectively. And, by and large, hospitals have not responded to the changes with larger workforces, leaving residents no choice but to compress their daily work into shorter time periods.

It appears that housestaff were formerly sleep deprived not by their own choice, but because they were required to accomplish enormous amounts of work.  The new duty-hour limits rearrangde their work into shorter shifts, without diminishing their total responsibilities.  This does not seem like much of an improvement.  The FIRST and iCompare trials were designed to test whether removing the new duty-hour limits, and thus increase sleep deprivation, would somehow help, which ignores the reason  the new duty-hour restrictions were enacted.  But simply shortening shifts accomplishes little as long as total workload remains the same.

Stimulants, An Even Worse Solution

So Clark and Harari confirmed my concerns about the FIRST and iCompare trials.  But they added a new and in some ways even more dire concern.  They uncovered an even more troubling response by medical academics to the zero-sum game which the managerialists ensure they are playing.

Adequate sleep is a fundamental physiological need. No amount of caffeine, prescription stimulants (as some physician leaders have advocated for) or 'alertness management strategies' can adequately compensate for acute and chronic sleep deprivation.

In an aside, Clark and Harari suggested the medical educators were advocating that housestaff use prescription stimulants to counteract the effects of sleep deprivation.  This seems astonishing.

Yet a brief search revealed many informal accounts of medical students and housestaff using psychoactive prescription drugs to increase wakefulness.  For example, see an account of a medical student using Focalin (dexmethylphenidate) here.  Surveys, for example by Shy et al of emergency residents, suggest that use of stimulants by housetaff is rare,(1), but survey respondents may be unwilling to admit to such behavior, and emergency medicine residents may work shorter shifts than medicine and surgery residents.

Also, there is some other evidence that medical educators may encourage use of stimulants.  At least one 2014 guest poster on the KevinMD blog stated

at one medical university, it is common knowledge among the student body that struggling individuals are encouraged to see a physician about their 'possible ADD,' or attention deficit disorder.

Furthermore, in 2009, Rose and Curry writing in the Mayo Clinic Proceedings (2) noted that 

extending the use of drug therapy to include resident with no identified sleep disorder to improve concentration and learning, improve wakefulness, enhance performance, and promote high-quality patient care (especially at night) raises a variety of concerns

without explaining who came up with that idea in the first place.  However, in a response to a letter challenging their commentary, they denied (3) that they were advocating for such drug use, but never made clear who else was.

As we have noted, stimulants used for attention deficit and hyperactivity disorder (ADHD) are  amphetamines or relatives of amphetamines, and have dangerous adverse effects.  Encouraging, even subliminally, medical trainees to use such dangerous drugs to try to compensate for underfunding of training programs seems unethical, as the above letter writer pointed out.(3)  That medical educators would resort to such an extreme solution suggests how they are now boxed in. 

Conclusion: the Problem is Managerialism   

While the ongoing trials of housestaff sleep deprivation have been largely anechoic, the recent Washington Post commentary by Clark and Harari make questions about why in the world medical academics would have set up such trials and continue to defend them even more stark.

But it seems that medical academics are boxed in, playing a zero-sum game.  They may know that there housestaff are overworked and sleep deprived, a situation that endangers the housestaff and their patients.  Yet every reasonable way one could imagined improving the situation would require spending more money, most likely to hire more people to spread the workload.  Yet spending more money may be an anathema to the generic managers to whom medical academics report.  Spending more money would decrease revenue, and for many managerialist managers, increasing revenue, not patient outcomes or physician performance, is the prime directive.    


We have frequently posted about what we have called generic management, the manager's coup d'etat, and mission-hostile management. Managerialism wraps these concepts up into a single package.  The idea is that all organizations, including health care organizations, ought to be run people with generic management training and background, not necessarily by people with specific backgrounds or training in the organizations' areas of operation.  Thus, for example, hospitals ought to be run by MBAs, not doctors, nurses, or public health experts.  Furthermore, all organizations ought to be run according to the same basic principles of business management.  These principles in turn ought to be based on current neoliberal dogma, with the prime directive that short-term revenue is the primary goal.

To conclude, as I did on my first post on the sleep deprivation studies....  I hope that the two studies create the degree of controversy they deserve, and that the federal government promptly starts investigating honestly and thoroughly.  I further hope that this unseemly episode causes medical educators to rethink the cozy or at least conflict averse relationships they have with their managerialist leaders.

True health care reform would restore health care leadership that understands health care and medicine, upholds the health care mission, is accountable for its actions, and is transparent, ethical and honest.



References

1.  Shy BD, Portelli I, Nelson LS. Emergency medicine residents' use of psychostimulants and sedatives to aid in shift work. Am J Emerg Med 2011; 29: 1034-36. Link here.

2.  Rose SH, Curry TB.  Fatigue, countermeasures and performance enhancement in resident physicians.  Mayo Clin Proc 2009; 84:  955-57.  Link here.


3.  Paparodis R. Fatigue, countermeasures and performance enhancement in resident physicians.  Mayo Clin Proc 2010; 85: 300 - 303.  Link here.
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Monday, 13 April 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.

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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