Background: There is widespread agreement that the full potential of health information technology (health IT) has not yet been realized and of particular concern are the examples of unintended consequences of health IT that detract from the safety of health care or from the use of health IT itself. The goal of this project was to obtain additional information on these health IT-related problems, using a mixed methods (qualitative and quantitative) analysis of electronic health record-related harm in cases submitted to a large database of malpractice suits and claims.
Methods: Cases submitted to the CRICO claims database and coded during 2012 and 2013 were analyzed. A total of 248 cases (less than 1%) involving health IT were identified and coded using a proprietary taxonomy that identifies user- and system-related sociotechnical factors. Ambulatory care accounted for most of the cases (146 cases). Cases were most typically filed as a result of an error involving medications (31%), diagnosis (28%), or a complication of treatment (31%). More than 80% of cases involved moderate or severe harm, although lethal cases were less likely in cases from ambulatory settings. Etiologic factors spanned all of the sociotechnical dimensions, and many recurring patterns of error were identified.
Conclusions: Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future.
Note the statement at pg. 5:
... The actual incidence of harm cannot be reliably estimated from this data; nonetheless, it is generally agreed that safety events represented in malpractice claims are the ‘tip of the iceberg', insofar as the vast majority of cases, even cases that involve harm, do not result in suits.
I've heard claims that up to 95% of potential meritorious medical malpractice suits never make it to the lawsuit stage due to difficulties in, and costs of, prosecution. Anecdotally, the latter observation corresponds to my own family's experience; several attorneys would not take my mother's EHR-related medical malpractice case initially, due to her age and concerns about expenses.
I note at my post today "Repeated crushing by alligators and crocodiles: ICD-10 has you covered. Harmed by bad health IT? No codes for that" at http://hcrenewal.blogspot.com/2016/01/repeated-crushing-by-alligators-and.html that repeated attacks and crushings by creatures of Order Crocodilia are well-covered by ICD-10, but health IT harms do not appear to be covered by the same mandatory coding system. My view is that this is likely by design, not due to lack of knowledge of these events by ICD-10 experts involved in creating this coding system.
... In the past two years, we [FDA] have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.
For more on these issues, see my April 9, 2014 essay "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" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.
HIT Errors 'Tip of the Iceberg,' Says ECRI Cheryl Clark, for HealthLeaders Media , April 5, 2013
Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.
... Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring. The volume of errors in the voluntary reports was she says, "an awareness raiser."
"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."
Your government at work, spending your tax dollars and making your doctors want to retire early due to increasing bureaucratic busywork. The new ICD-10 coding system they must now use has codes like these, in case you get attacked by a crocodile or alligator.
It even has codes for repeat crushing by the critters...
Notably missing: there are no codes for harms caused by defective, mis-designed or badly implemented electronic medical records/ordering/lab review systems, which are occurring as documented in numerous posts on this blog. (My mother would comment, but she is deceased from ICD-10 code ...uh, oh wait, no code for that...)
W58.01XA Bitten by alligator, initial encounter W58.01XD Bitten by alligator, subsequent encounter W58.01XS Bitten by alligator, sequela W58.02XA Struck by alligator, initial encounter W58.02XD Struck by alligator, subsequent encounter W58.02XS Struck by alligator, sequela W58.03XA Crushed by alligator, initial encounter W58.03XD Crushed by alligator, subsequent encounter W58.03XS Crushed by alligator, sequela W58.09XA Other contact with alligator, initial encounter W58.09XD Other contact with alligator, subsequent encounter W58.09XS Other contact with alligator, sequela
Haven't searched ICD-10 for "abduction and experimentation by Roswell Greys" yet.
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.
One Explanation - Finance Leaders Ascendant on the Boards of Health Care Non-Profits
I just found a useful article that provides one explanation for the rise of managerialism in health care non-profit organizations. It postulated that the increasing prevalence of leaders of finance firms on the baords of trustees of such organizations led to increasingly managerialistic leadership.
Thanks to a link from Naked Capitalism to a post on ShadowProof that led to an article in the Stanford Social Innovation Review by Garry W Jenkins, entitled, "The Wall Street Takeover of Nonprofit Boards." It described a study of the membership of the boards of 23 of "the nation's leading private research universities," most of which have medical schools and academic medical centers, and all of which have major biomedical and/ or health care research operations, as well as leading liberal arts colleges and large New York City non-profit organizations, including a few hospitals. (We will restrict our discussion of the quantitative results to the former group of leading universities.)
The most important result was that 40% of trustees of the universities in 2014 "had a substantial professional career in finance," up from 19% in 1989. Futhermore, in 2014, 56% of university board leadership positions were held by people from finance, up from 26% in 1989. The author noted that the prevalence of people from the finance sector on university boards was far bigger than their prevalence in the population. Only 6% of the private non-farm workforce in the US was in finance in 2012.
The author summarized his findings:
Over the past twenty-five years the compostion of the boards at some of America's most important nonprofit organizaI I has dramatically changed. Without much notice, a legion of Wall Street executives (investment bankers, hedge fund managers, and others) has taken a growing number of seats in nonprofit boardrooms. Not only that, they hold a disproportionate share of the leadership positions on these boards.
He then linked the increasing dominance of non-profit governance to the increasing tendency of these organizations to be run like for-profit businesses, that is, the rise of "managerialism."
Scholars and practitioners have documented various pressures placed on nonprofit organizations by donors and private foundations to adopt business approaches.
Although some of the pressure to adopt business approaches has come from external forces, it may also be true that the concepts and norms of philanthrocapitalism are also now carried into nonprofit organizations by the directors of public charities themselves.
He then provided a much more detailed discussion:
As financiers come to dominate the boards of leading nonprofits, it is not surprising that their approaches and priorities have made their way, very explicitly and fundamentally, into the governance of the nonprofit sector. Practices such as data-driven decision-making, an emphasis on metrics, prioritizing impact and competition, managing with three- to five-year horizons and plans, and advocating executive-style leadership and compensation have all become an essential part of the nonprofit lexicon.
Nonprofit leaders regularly hear about these finance practices from board members and donors whose native habitat is the financial services world. Moreover, nonprofit managers have come to accept them as reasonable principles upon which donors base their giving. More often than not, organizations are also expected to incorporate these principles in the management of the not-for-profit enterprises for which managers and boards share responsibility.
Although many of these business approaches may strengthen nonprofit capacity, we should also be mindful of the ways in which these same tools can morph into pathologies, ignore the costs or trade-offs associated with extending business thinking to the charitable sector, or distort organizational priorities. Numerous critics have written thoughtfully about the ways in which market-based thinking and approaches applied to the nonprofit sector provide false promise, with the potential to dilute charitable values, undermine long-term mission focus, incentivize small, incremental goals, and threaten shared governance and other forms of participatory problem-solving.
Beyond leading to the borrowing of financial concepts and tools in the boardroom, the rise in the number of nonprofit directors with ties to finance may also contribute to deeper changes in the underlying institutional values and motivations, a trend that economic sociologists refer to as the financialization of the nonprofit sector.
Financialization describes a spread of financial logics, influence, and strategies into new fields and organizations in ways that transform the culture, policies, and values of institutions. Indeed, wealthy nonprofits-like colleges, universities, and museums-have long engaged with financial markets as endowment investors, but the scope and scale of today's nonprofit borrowing, aggressive debt financing, securitization transactions, and complex real estate transactions is unprecedented. Such shifts may affect the organization's strategic direction and orientation in a number of ways, including directing board and management attention to debt service, incentivizing organizations to invest resources on activities that return higher profit margins to cover debt service, elevating the centrality and importance of financial managers in strategic planning and decision-making, and increasing the need for and power of senior staff well versed in complex financial instruments.
The list of practices above and the description of financialization sound very much like standard operating procedures of generic management which we have previously described. The discussion of pathologies above sounds similar to our discussions of how managerialism distracts from or undermines the mission.
The one quibble I have with Jenkins' discussion is that it puts almost the entire onus on the financial leaders on the boards of trustees, rather than the top managers of the organizations. It may be that increasingly financialized boards hire increasingly generic managers, but there may be a symbiosis between the two groups.
So Jenkins' conclusion seems reasonable:
if boards are to operate as designed, and if they are to be maximally effective, then the composition of nonprofit boards must be more diverse and not dominated by financiers.
But the problem of financial sector domination of health care non-profit boards may be even worse than that Jenkins describes.
The Dark Side of Finance
Even though Mr Jenkins is concerned about excess of influence of too many financially oriented people on the boards of non-profits, he is quite respectful of those in the finance field. "Individual finance professionals do bring skills, wisdom, and other positive attributes to nonprofit boards." He also wrote, "This is not to say that finance professionals care less (or more) about a nonprofit organization or its mission. Nor do I believe that all finance professionals think alike." Many finance professionals may be very well-intentioned, of course. But Jenkins seems to thus ignore the dark side of finance's recent history.
Finance firms are certainly known for the use of "financial logics, influence and strategies," and the employment of specific practices. However, after 2008, they were also known for dangerously slipshod, if not unethical, sometimes corrupt management.
In 2008, the global financial collapse/ great recession reshaped the global economy, and has been linked to the stagnation of the middle class and growth of plutocracy. There have been numerous discussions of the role of the leadership of financial organizations in these events. The blog Naked Capitalism has been covering these issues from the global financial collapse to the current day. Some of the very many excellent sources on this era include the movie Inside Job,
A chapter in Predator Nation was entitled "Crime and Punishment: Banking and the Bubble as Criminal Enterprises. In it, Mr Ferguson noted the following list of
prosecutable crimes committed during the bubble, the crisis, and the aftermath period by financial services firms ...
Securities fraud (many forms) Accounting fraud (many forms) Honest services violations (mail fraud statute) Bribery Perjury and making false statements to federal investigators Sarbanes-Oxley violations (certifying false accounting statements) RICO offences and criminal antitrust violations Federal aid disclosure regulations (related to Federal Reserve loans) Personal conduct offenses (many forms: drug use, tax evasion, etc)
Most of these never led to prosecution in an era of the revolving door and exceedingly lax law enforcement of actions by big corporations ("too big to jail") Yet Ferguson argued for investigation of possible illegal acts by many large companies, and specifically named Citigroup, AIG, Lehman Brothers, Goldman Sachs, JP Morgan Chase as worthy of investigation.
Many of these organizations' leaders also were on the boards of health care organizations. Since 2008, we began noting that the governance of prominent health care non-profits was often dominated by finance firms, including those implicated in the 2008 collapse, although our observations were case-based, not quantitative. The concern was not simply that health care organizations were being led into generic management and "managerialism," but that that the incompetence, unethical behavior, and corruption in the finance sector could cause equally bad problems in health care. We have no systematic proof of that, but consider some of our more colorful cases, which include leaders of the financial firms named by Mr Ferguson...
Hedge Fund U - Bernie Madoff, the supposed finance wizard who went to jail for a huge Ponzi scheme was on the board of Yeshiva University. The chairman of the board's finance committee was Ezra Merkin, a hedge fund operator who ran a "feeder" operation for Madoff's Ponzi scheme.
A Board of Trustees, or a Social Club for the Superclass? - Of the 29 non-physician board members of the Hospital for Special Surgery, 23 had major relationships with, and many of these had leadership roles in finance firms, including such bailed out, too big to fail firms as AIG, Bank of America, Citigroup, Goldman Sachs, JP Morgan Chase, and Wachovia.
A "Very Well Paid Boob" on the Harvard Corporation? - the university's governing board included one of the architects of the overgrowth of Citigroup, which had to be bailed out, and also of the deregulation of finance which allowed the company to be too big to fail.
Yet outside of a few grumpy bloggers, the continuing presence of leaders of too big to fail, too big to jail, often bailed out financial firms on the boards of some of our most notable health care organizations and universities has attracted almost no comment, and less concern.
Summary
The continuing dysfunction of US health care, with ever rising costs, stagnant quality, and still inadequate access, is well known. There is constant loud argumentation over "Obamacare." (Congress just passed a repeal of it, which the president has threatened to veto.) Yet there is little in depth discussion or inquiry about what is really going wrong. The really unpleasant issues rarely surface in polite discussion. We have called this aversion to direct discussion of big problems the anechoic effect.
So I hope that there is more discusison of who gets to lead health care organizations, and who gets to sit on the boards that exercise stewarship over them. We need far more light shined on who runs the health care system, using what practices, to what ends, for the benefits of whom.
True health care reform would enable transparent, honest, accountable governance and leadership that puts patients' and the public's health over ideology, self-interest, and self-enrichment.
As I have written before as a physician who saw too many dire results of intravenous drug abuse, I was amazed how narcotics were pushed as the treatment of choice for chronic pain in the 1990s, with the result that the US was once again engulfed in an epidemic of narcotic abuse and its effects. In mid-December, 2015, as reported in the Washington Post,
The nation continues to suffer through a widespread epidemic to prescription opioids and their illegal cousin, heroin. The CDC estimated that 20 percent of patients who complain about acute or chronic pain that is not from cancer are prescribed opioids. Health-care providers wrote 259 million prescriptions for the medications in 2012, 'enough for every adult in the United States to have a bottle of pills,' the CDC wrote.
Last week, the National Center for Health Statistics reported that the number of overdose deaths from legal opioid drugs surged by 16.3 percent in 2014, to 18,893, while overdose fatalities from heroin climbed by 28 percent, to 10,574. Authorities have said that previous efforts to restrict prescription drug abuse have forced some people with addictions to the medications onto heroin, which is cheaper and widely available.
This rising tide of death and morbidity seems to have been fueled by reckless, sometimes deceptive, sometimes illegal marketing by the pharmaceutical companies that produced narcotics other than heroin.
Background - Legal Drug Pushing
As I wrote in 2013,
the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an 'ethical' drug company. In the earlier days of Health Care Renewal, we first posted (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population. Then in 2007 came the spectacular case of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for 'misbranding' Oxycontin, that is, promoting it far beyond any medically legitimate use in severe chronic pain. Following that various investigations, well chronicled in the Milwaukee Journal Sentinel, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more 'legal' narcotics For example, see the Journal Sentinel reports the subversion of : medical schools and their faculty; .medical societies, disease advocacy groups, and foundations; and guideline writing panels. In 2012, we posted about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.
As I described in that 2012 post, the new narcotic pushers relied on only the most sketchy evidence about the safety of prescription narcotics. In the 1990s, they taught that the rate of addiction caused by prescribing legal narcotics was only 1%, but this was based on a tiny flawed case series of a mere 38 patients. In 1996, a consensus statement from the American Academy of Pain Medicine and the American Pain Society, entitled "The Use of Opioids for the Treatment of Chronic Pain," included the following statements,
Pain is often managed inadequately, despite the ready availability of safe and effective treatments.
Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.
Yet one of the primary proponents of profligate use of narcotics to treat chronic pain later admitted he
erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'
Also,
'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.
In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.
The CDC Attempts to Moderate the Use of Opioids for Chronic Pain
So to me it seems quite reasonable the US Center for Disease Control and Prevention (CDC), being cognizant of the rising toll of narcotic addiction, would attempt to do something about it. As reported by the Washington Post,
The government on Monday urged primary-care physicians who prescribe opioids for pain relief to rein in their use of the drugs, proposing new guidelines that call for a more conservative approach than the one that has led to a crippling epidemic of addiction to the powerful narcotics.
Just a few days after a new report showed a surge of drug-related overdoses in 2014, the Centers for Disease Control and Prevention suggested in draft recommendations that physicians tackle chronic pain with other methods, such as physical therapy and non-opioid analgesics, before turning to the powerful medications. If opioids, such as OxyContin and Percocet, are necessary, the agency recommended short-acting versions over extended release formulations, the lowest possible dose and short-term prescriptions.
It also suggested that doctors ask patients to take urine tests before prescribing opioids and additional urine tests at least once a year if they continue on the drugs, to ensure that they aren't secretly taking other opioids or illegal drugs.
'What we want to just make sure is that doctors understand that starting a patient on an opiate is a momentous decision,' said CDC director Tom Frieden. 'The risks are addiction and death, and the benefits are unproven.'
Based on the events since they 1990s, the lack of clear data from well performed randomized controlled trials of the effectiveness of opioids in chronic pain, and their obvious, known risks, that seems like common sense to me.
The Strong but Obscure Opposition to the CDC Guidelines
However,others disagreed. The guidelines attracted immediate opposition, for reasons that were not immediately obvious. Four days after the Post article, the Associated Press reported that the guidelines were in big trouble,
A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.
Also,
Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as 'shortsighted,' relying on 'low-quality evidence.' They said they planned to file a formal complaint.
The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.
Anti-addiction activists worry the delay could scuttle the guidelines entirely.
This, however, did not make much sense. I repeat, the evidence that narcotics are effective for chronic pain other than that due to terminal cancer is very weak. The evidence that opioids have multiple side effects, some fatal, and can cause addiction, which has more side effects, and bad societal consequences, is strong. So the evidence that narcotics have benefits that are worth their harms, both to individuals and society, in this setting is essentially non-existent. So why did these guidelines go too far? Why invoke low quality evidence, when the evidence that is low quality is about the benefits of the drugs? Who should be sued? Furthermore, why did the CDC cave in so readily to these critics?
The AP noted,
But industry-funded groups like the U.S. Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals.
Of course they could reduce access. The whole point of the guidelines is to reduce access. But who would want more access to medicines that do more harm than good?
Then there was the issue of just who it was who opposed the guidelines. Much of the opposition seemed to come from rather obscure organizations with authoritative names. Some of the opposition was chronicled by equally obscure, apparently journalistic organizations. (From now on, I will highlight these mysterious organizations by using bold, italic text in this color.) For example, according to the Washington Post,
Many of the patient and physician groups opposing the CDC guidelines are part of a larger coalition called the Pain Care Forum, which meets monthly in Washington to strategize on pain issues. Officials from the White House, the FDA, NIH and other agencies have met with the group over the years, according to documents obtained by The Associated Press under the Freedom of Information Act.
The Pain Care Forumpresents itself as a leaderless collective that does not take formal positions. But most members receive funding from drugmakers, including OxyContin-maker Purdue, whose chief lobbyist helped found the group and remains at its center.
The mission of the Pain Care Forum, its organizational nature (informal group, membership society, non-profit advocacy group, etc), its leadership, and its sources of funding were not entirely obvious from this article. But certainly the drift of the article was that the organization maybe represents pharmaceutical manufacturers, particularly the previously discredited Purdue Pharma (see above) more than others. So why not take what it says with many grains of salt.
But who threatened to sue? Which FDA officials chimed in, and why, given that the FDA does not have a mission that includes writing guidelines? That was not clear from the AP story.
My attempts to gain further clarity produced more mystification. A Medscape article also claimed that the opposition to the CDC guidelines included Dr James Madara, the Executive Vice-President and CEO of the American Medical Association, and "some members of the Interagency Pain Research Coordinating Committee [who] criticized the process, according to the Pain News Network." It was not clear whether Dr Madara's viewpoint had broad support in the AMA, which members of the Interagency Pain Research Coordinating Committee opposed the CDC guidelines, and whether this opposition was personal, or reflected the considered viewpoint of the committee. Furthermore, that committee's purview does not obviously include clinical guideline development or public health, so why it was commenting on this issue was also unclear.
The Pain News Network story which apparently was the source used by the Medscape in turn referred to a Politico story, but one which is only available to subscribers. The Pain News Network also credited a survey by "the Pain News Network and the Power of Pain Foundation."
The Medscape article said nothing more about the Pain News Network.which is not exactly a household word in health care journalism. The Pain News Network story did not give more detail about the Power of Pain Foundation, whose mission, nature, leadership, funding etc was not obvious.
The Pain News Network story also quoted the Washington Legal Foundation's chief counsel.
The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers.
Similarly, the Washington Post article also credited the Washington Legal Foundation's opposition to the CDC guidelines,
The Washington Legal Foundation, a public interest law firm dedicated to protecting the free enterprise system, accused the CDC of trying to formulate them secretly by failing to make public the work of its original advisory committee, the Core Expert Group. The CDC disputes that accusation, but issued the recommendations in draft form Monday and will have them reviewed by another advisory panel after receiving more comment over the next 30 days, Frieden said.
Yet, neither the Pain News Network nor the Post explained why a group supporting "free enterprise" was so concerned about this issue, or what expertise it might have in this area. It is ironic that a group that proclaims opposition to secrecy seems less than transparent about its involvement in this issue.
Finally, the nature of the Pain News Network, which claims to be a "non-profit, independent news source," is also obscure. It appears to be one of those non-profits that has no physical address per its web page of contact information, does not disclose its sources of funding, and if it files US Internal Revenue Service 990 forms, I cannot find them.
The most detailed article I could find about the substance of the complaints about the CDC guidelines was in another obscure source, the Legal News Line. The article mostly described the concerns of
Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of theCenter for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.
Pitts' main issue was that a member of the group that developed the CDC guidelines was biased. He said,
'So you have to have as open of a mind as possible.'
And that’s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC’s “Core Expert Group,” which played a key role in developing the agency’s opioid guidelines.
Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.
PROP’s mission, according to its website, is to 'reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.'
'Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,' Pitts said.
'For the CDC to say, we’re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?'
The Legal New Line's example of supposed journalism did not apparently ask Pitts what was "lunatic" about wanting to promote cautious and responsible prescribing of opioids. That seems to me like common clinical sense, the opposite of insanity.
Also, Pitts complained that beyond this alleged bias, Dr Ballantyne had a conflict of interest,
Pitts noted Ballantyne’s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.
Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.
Note that in the first paragraph above, the writer apparently meant that the law firm donated to the campaigns of the attorney generals.
More importantly, why the apparent conflict of interest affecting a single member of a large group - the core expert group of which Dr Ballantyne sat included 17 people - was so important was not apparent from Mr Pitts' argument. Mr Pitts did not explain how any sort of advisory group that included experts in the field could avoid people who already had strong opinions about that field. The Legal News Line article did not discuss Mr Pitts' own background, or provide any information about the Center for Medicine in the Public Interest, which he leads.
I could not find reporting in major news outlets or medical/ health care scholarly publications about the opposition to the CDC guidelines beyond the stories in the Washington Post, AP, and Medscape, and a brief report in Modern Healthcare. I did find numerous articles on yet another little known website called the National Pain Report, (e.g. see this one).
So to summarize so far, the opposition to the new CDC opioid guidelines was apparently strong enough to delay, if not derail them. Yet who was in the opposition, their funding, and their interests remains obscure. The arguments of the opposition remain unclear. Even some of the purported journalists reporting on the opposition remain mysterious. There seems to be a tremendous amount of fog surrounding the opposition to more conservative prescribing of narcotics for non-cancerous chronic pain.
It was striking that much of the opposition seemed to come from rather mysterious organizations, the Pain Care Forum, Power of Pain Foundation, Washington Legal Foundation, and Center for Medicine in the Public Interest. However, the reporting on these organizations was minimal. Furthermore, some of the news sources reporting on the opposition to the CDC guidelines also were rather mysterious, such as the Pain News Network, National Pain Report, and Legal News Line.
One recent media article, and some of our previous blogging, though suggest that the opposition organizations all have ties to the pharmaceutical industry, and in several cases, directly to one of the major producers of legal opioids. On December 23, 2015, Lee Fang wrote in the Intercept by way of an introduction,
The pharmaceutical companies that manufacture and market OxyContin, Vicodin, and other highly addictive opioid painkillers — drugs that have fueled the epidemic of overdoses and heroin addiction — are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.
In particular,
An investigation by The Intercept has found that the pharmaceutical companies that dominate the $9 billion a year opioid painkiller market have funded organizations attacking reform of the prescribing guidelines:
The Washington Legal Foundation, a nonprofit that litigates to defend 'free-market principles,' threatened the CDC with legal action if the agency moved forward with the proposed opioid guidelines. The WLG claimed the CDC’s advisory panel for the guidelines lacked 'fair ideological balance,' because it included a doctor who is part of an advocacy effort against opioid addiction. The WLF does not disclose donor information, but has filed friend-of-the-court briefs on behalf of Purdue Pharma, the makers of OxyContin. In a recent article with Pain News Network, a spokesperson for Purdue Pharma conceded: 'We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants.'
The Pain Care Forum organized opposition to the CDC prescribing guidelines, mobilizing regular meetings among stakeholders opposed to the idea, according to an investigation by AP reporter Matthew Perrone. A recently re-filed complaint by the City of Chicago found that Burt Rosen, the chief in-house lobbyist for Purdue Pharma, controls the Pain Care Forum. A former drug company employee allegedly told investigators that Rosen tells the Pain Care Forum 'what to do and how we do it.' The Pain Care Forum is funded through contributions by Purdue Pharma, as well as major opioid manufacturers Cephalon, Endo, and Janssen, a subsidiary of Johnson & Johnson.
The Power of Pain Foundation, a groupfunded by Purdue Pharma, asked supporters to contact the CDC in opposition to the guidelines, claiming that 'taking away pain medication and making providers afraid to prescribe due to your guidelines is only going to make more abusers, increase suicides, and tear apart the lives of millions.'
Fang also noted that the Legal News Line, the source of the story documenting Peter Pitts' problems with the CDC guidelines, also is tied to the pharmaceutical industry:
The U.S. Chamber of Commerce, a corporate lobbying group that represents opioid manufacturers, including Johnson & Johnson, issued a press release masquerading as a news story [published by the Legal News Line] criticizing the CDC guidelines. (The U.S. Chamber operates a public relations effort dressed up as a bona fide media outlet called Legal Newsline, which it uses to disseminate stories that support the political priorities of its member companies.)
In addition, on Health Care Renewal we have previously discussed the Center for Medicine in the Public Interest. Back in 2008, we noted that when writing for the New York Times, Mr Pitts had to disclose that the Center for Medicine in the Public Interest receives pharmaceutical industry funding, including from Pfizer and the PhRMA. At that time, Mr Pitts' day job was Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee had many big pharmaceutical accounts Since then, he moved on to become director for global healthcare at Porter Novelli, also a public relations/ communications company with many health care corporate clients, including pharmaceutical companies, and now appears to be a consultant in the life sciences area for YourEncore. I cannot find any updated information on current Center for Medicine in the Public Interestfunding, but there is no reason to think that it is not still funded by the pharmaceutical industry.
Mr Pitts' published objections to the CDC guidelines had to do with the supposed bias and conflicts of interests of a single member of the guideline expert panel, and the alleged lack of transparency of the guideline project. Yet Mr Pitts was not very transparent about his own background, and his and his organizations' financial interests. For Mr Pitts to condemn the guideline panel member's conflict while hiding his own conflict amounts to a garish example of the logical fallacy of special pleading. Similarly, the Washington Legal Foundation's objections to the alleged biases of the guideline panel, given that foundation is apparently funded by Purdue Pharma, is another garish example of the same logical fallacy.
On the other hand, the Pain News Network and the National Pain Report remain obscure. The former claims to be a non-profit organization, but I cannot find its federal 990 filing, identify its board of trustees, or even determine its physical address. It does claim an affiliation with the Power of Pain Foundation. The National Pain Report at least has a physical address, which it shares with the equally obscure American News Report. Other details, like its ownership, remain obscure. The failure of supposedly journalistic organizations to publicly reveal basic information about their nature and operations does raise suspicions that they are not really so journalistic.
Summary
In summary, the organizations most widely mentioned as opposing the new CDC guidelines that recommend more conservative use of opioids for chronic pain seem to be heavily involved with the pharmaceutical companies that make such opioids. Thus, the opposition to the guidelines seems to be arising from a stealth public relations campaign leading to stealth health policy advocacy. Furthermore, at least so far, the objections to the guidelines do not seem clearly based on logic and good evidence from clinical research, again suggesting they are more about financial interests than improving patient outcomes and reducing risks.
Overuse and misuse of opioids, which may lead to all the individual and social consequences of opioid addiction, are clearly major, worsening medical and public health issues. We need earnest effort to address these problems, which should be informed by a logical, evidence-based discussion of the clinical and social realities. Such a discussion is only hindered by the growing fog of objections launched by mysterious organizations funded by the companies who have made the most money selling narcotics. So we also need some societal response to the growing domination of the public debate by marketing and public relations, often based on emotional manipulation, logical fallacies, and outright deception.
We cannot address our worsening health care dysfunction when public discussion and policy making blunders about in the fog of stealth health policy advocacy, stealth lobbying, and stealth marketing. If the leaders of big health care corporations really believe they are making good products and providing good services that add value and improve patients' and the public's health, they ought to be able to rely on honest and open communications. If they cannot disavow stealth public relations and stealth marketing, we ought to disavow the companies that practice them.
Not So Cheerful Musical Interlude
Unfortunately, given the topic of this post, here is Lou Reed singing Heroin
ADDENDUM (4 January, 2016) - This post was republished on the Naked Capitalism blog, sadly without Lou Reed. See the interesting comments appended to that version.
Also, this post was republished in its entirety on OpEdNews.
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.
Internal FDA Memo ("not intended for public use") on potential dangers of health IT. Download the full PDF by clicking here.
