JAMA LAYS AN EGG

JAMA LAYS AN EGG 

Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that post I also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.

Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a reply from the original authors. So JAMA didn’t deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.

The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.

The closing sentences of their reply letter illustrate these issues: “Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work.” The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients’ consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.

If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.

UPDATE 05-03-2016
Apparently the link to my earlier post is inoperative. My apologies. Here is a link that should work.
http://hcrenewal.blogspot.com/2016/01/jama-jumps-shark.html 

JAMA JUMPS THE SHARK

JAMA JUMPS THE SHARK

Medical journals are supposed to promote professional values – scientific, social, and ethical. Quality matters, in each of these domains. Lately, however, highly ranked journals are failing in respect of ethics commentaries. Some editors seem happy to publicize or even to co-author commentaries that are dismissive of current ethics initiatives – like transparency of data reporting and disclosure of conflicts of interest (COI). That’s one way for journals to jump the shark in the race for ratings. They surely get attention and applause in some quarters – but those stunts are net negatives for the journals. Here is one example.

Last fall, JAMA went splashy with a sappy Viewpoint article on conflict of interest by Anne R. Cappola and Garret A. FitzGerald. Anne Cappola is also an associate editor of JAMA – what a coincidence! The article was a Pollyanna piece by these two professors at Penn, promoting pushback on perceived pharmascolds, but really just papering over the problem of COI. The sappy formula? They declared conflict of interest to be a pejorative term that should be replaced by confluence of interest. This casuistry was backed up by wishful thinking and hortatory hand waving, weakly argued. Mostly, it gave the impression that the authors, presuming to speak for investigators generally, were offended by the increasing regulations for managing COI. Those developments have occurred at the Federal, institutional, and publication levels. Worse, the authors ignored the reality of recent corruption that led to those new regulations. That uncomfortable fact was airbrushed out of their discussion. In response, one critic of confluence of interest, writing on the COI blog, aptly raised a comparison to Wall Street: “The phrase also reminds me of a statement by then king-of-the-hill securities analyst Jack Grubman: “What used to be a conflict is now a synergy.” (Three years later Grubman was fined $15 million dollars and barred from the industry for life for what were apparently still considered COIs.)”

The Viewpoint article appeared on-line September 24, 2015, and four days later I sent a critical reply to JAMA. The printed version of the Viewpoint article appeared November 3, 2015, and on 4 December, 2015 I was notified that JAMA chose not to publish my letter to the editor. During the following six weeks, now nearly five months since it appeared, JAMA published no replies whatsoever to the Viewpoint article. Could it be that JAMA has deep sixed all the responses? That’s one way to manage bad publicity, but it is inconsistent with the standards we expect of a journal like JAMA. Here is the text of my letter to the editor of JAMA. Keep in mind that there is only so much one can say within a limit of 400 words and 5 references.

LETTER TO EDITOR, JAMA 09-28-2015            Text word count 389

                                                                                5 references

TITLE: CONFLICT OF INTEREST

In their recent Viewpoint (1), Anne Cappola and Garret FitzGerald recommended replacing the term conflict of interest (COI) with confluence of interest, declaring a pejorative connotation of the term conflict. A better suggestion would have been competing interest, which already is in wide use (2) and which does not paper over the problem. The authors did not frankly acknowledge the gravity of recent COI scandals that led to the situation they decry. Sadly, there are real, common, serious, and unacceptable conflicts of interest. Boundaries are needed, and the authors’ effort to weaken the boundaries is misguided.

Their case for re-framing COI more benignly as a confluence of interests is weakly argued. For instance, they warned of concern that current policies on COI “… might restrain innovation and delay translation of basic discoveries to clinical benefit.” (1) They produced no evidence for that speculative assertion, though they said it was a key reason for their endeavor. Moreover, COI policies do not demonize collaboration with industry. We once had an honorable tradition of interacting with industry while retaining our integrity as clinical scientists. That tradition broke down when academic investigators in many specialties were coöpted as key opinion leaders (KOLs) by the marketing departments of corporations. There followed an era of corruption in corporate-funded and KOL-managed continuing medical education and journal supplements; of experimercials disguised as KOL-initiated clinical trials (3); of rampant, biased ghostwriting, commissioned by corporations and often with cynical honorary KOL authorship; and of selective analyses of clinical trials data designed to exaggerate benefits, minimize harms, and maximize markets (4). We can readily agree with the Viewpoint authors that these practices had the effect of “biasing the interpretation of results, exposing patients to harm, and damaging the reputation of an institution and investigator” (1). Inevitably, those practices and individuals were exposed, which led to Congressional action and to staggering legal penalties (over $3 billion in the case of GlaxoSmithKline) (5). In response, COI policies were strengthened at the Federal and institutional levels and, of course, they now inconvenience everybody. Such is the way of bureaucracies. As we survey the aftermath, we should direct our annoyance to the many opportunistic investigators who entered into those compromised relationships with industry. It makes no sense now to shoot the messengers or to use sophistry in an attempt to define the problem away.

ACKNOWLEDGEMENTS

The author declares no competing financial interest or other conflict of interest.

REFERENCES

(1) Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA. Published online September 24, 2015. doi:10.1001/jama.2015.12020.

(2) James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet's policy on conflicts of interest––2004. Lancet. 2004; 363 (9402):2-3.

(3) Carroll BJ. Sertraline and the Cheshire cat in geriatric depression. American Journal of Psychiatry. 2004; 161(6): 1145-1146.

(4) LeNoury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.

(5) U.S. Department of Justice, Office of Public Affairs. GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. July 2, 2012. http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report Accessed 09-25-2015.

So, yes, Virginia, there is real COI and there is real corruption in medical science. You cannot make them go away by wishing them away. And, JAMA, if you allow your editors to promote divisive, weak, and problematic ethics positions, at least have the decency to allow debate.

Bernard Carroll.

Why is the New England Journal of Medicine Scolding "Pharmascolds"?

I, a normally quiet blogger on this site, was disquieted by what may be a backlash aimed at quashing the anti-conflict-of-interest movement.

Lisa Rosenbaum just published her second of three treatises in the highly prestigious New England Journal of Medine, scolding "pharmascolds" (see Conflicts of Interest: Understanding Bias — The Case for Careful Study). "Pharmascolds" is the term Rosenbaum and others use for those of us at Health Care Renewal, the Institute of Medicine, and countless medical journals and institutions.  Why?  Because we dare assert there is great danger when providers practice though saddled by (potential) conflicts of interests in medicine.  Such conflicts are created when physicians (up to 94% of us, according to Rosenbaum's research), other health care providers in practice, and health care organizations accept, not only gifts and trinkets, but also large, sometimes clandestine consulting fees and other arrangements from pharma and device companies, all the while providing direct patient care using the companies' products.

Rosenbaum and others say we pharmascolds are essentially self-righteous and obstructionist, holding back the progress of medical science.  In this article, she seems to claim that not proving direct patient harm from a specific questionable financial arrangement with a company whose product we may therefore more likely prescribe, speak well of, or publish (pseudo)evidence supporting the use of, is enough of a reason to justify the arrangement. 

Wouldn't that be the same as saying, "Until you actually crash into another car while texting, it's ok to text while driving, even if it's distracting."?

Rosenbaum uses mainly anecdote to prove her point, and appeals to a little-quoted, but still important, heuristic/bias called "moral liscensing."  Rosenbaum describes the phenomenon correctly: "once disclosure [of a conflict of interest] gets the weight [of guilt] off your chest, you feel liberated and may feel licensed to behave immorally."  True.  But then Rosenbaum seems to support non-disclosure of acts that create conflicts of interest, because disclosure doesn't decrease the acts themselves.

Rosenbaum goes further. At the same time as she supports non-disclosure of conflicts, she attempts to paint those who accept conflict-generating arrangements and keep them clandestine as victims--afraid to "come out of the closet" because doing so is socially taboo, though the activity is not wrong. 

I beg to differ.  For certain acts, potential conflicts, and actual conflicts, it seems to me that mere disclosure of the act or conflict shouldn't relieve one of the guilt associated with the act or conflict.  It also seems disclosure of a conflict should not make a speaker seem more credible to his/her audience because of its disclosure, though some research Rosenbaum quotes seems to show that disclosure improves credibility. 

Perhaps the stronger argument for disclosure is to disqualify people from activities that should be prohibited for people in conflict, as well as to warn people away from engaging in questionable activities that would result in conflicts. 

In an unbelievable twist of logic, Rosenbaum seems to be arguing in this article for more, not less of these questionable activities, in the interest of advancing science, until we prove patients are directly hurt by them, i.e., we have a "wreck."  Heck, let's get rid of traffic lights too, while we're at it.  People have eyes. We should trust them. They should be able to avoid accidents voluntarily, on their own.

In short, how could Dr. Rosenbaum not see that the best solution for the "problem" of conflicts of interests is avoidance when possible?  One can't help but wonder if she and the Journal aren't blinded by the shimmer and pull of powerful, influential organizations, ones so shiny, so strong, and so ubiquitous that resistance is just too hard for her, the Journal, and for 94% of us.

Conflicts of interest should be avoided.  Society has accepted that improved health will result not just from secondary prevention (e.g., not texting while driving after one has had an accident from the activity), but also from primary prevention (not texting while driving, even before an accident occurs). 

Wally R. Smith, MD

Citizen's Council for Health Freedom: "The Truth about Electronic Health Records"

The Citizen's Council for Health Freedom (CCHF) is an independent 501(c)3 non-profit organization with a mission "to protect health care choices and patient privacy" (www.cchfreedom.org/about.php).

Its president, Twila Brase, wrote this piece about Electronic Health Records in the CCHF newsletter of June 18, 2014, observing some "inconvenient truths" and highlighting one of the most asinine statements I've ever seen about computers made by (of course) a venture capital official who happened to play a significant role in formulating the Affordable Care Act a.k.a. "Obamacare":

http://healthenews.cchfreedom.org/newsletter.php/148

The Truth about Electronic Health Records

Propaganda only works for so long. Pretty soon truth catches up to it. This is exactly what's happening with electronic health records.

If you're a doctor you know how bad the government-mandated electronic health record (EHR) is. But if you're a patient, you may not realize that EHRs are endangering your life and jeopardizing medical excellence.

The EHR is nothing like what Big Government, Big Data, and Big Health said it would be. They promised convenience, coordinated care, fewer medical errors, more efficient medical practice, and portable medical records. They never meant it and it hasn't happened. These data systems were created for billing, data collection and government control of doctors, not patient care.

From all I have seen over the years, I must agree with the last two sentences above. The pioneers who explored this technology back to the 1950's warned against the nightmare that exists today, but I don't think they believed we would ever get to where we are in 2014.

Further, while Politico did not explicitly mention risk to life and limb caused by these systems, Twila Brase did.  "EHRs are endangering your life" is the elephant in the living room that the industry and its well-captured (and perhaps lubricated?) "regulators" simply will not address in a serious manner.

It has been my belief this reflects self-serving willful blindness, gross negligence and/or pecuniary motives, but I also believe that a fundamental malevolence on the part of people and organizations who know better increasingly needs to be considered as a contributor to the recklessness in the health IT sector.  These are experimental technologies of admittedly (by the regulators) definite but unknown risk, due to impediments to that knowledge.  Demanding their rapid diffusion under threat of penalty while knowing about the risks, and the uncertainty about magnitude, certainly does not reflect a benevolent disposition.

For more on the above points see my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) and its 11 points and hyperlinks.  This post and its linked brethren represents an indictment of sorts against the health IT hyperenthusiast culture and the unprecedented regulatory accommodation enjoyed by this sector.

Arthur Allen at POLITICO Pro eHealth (http://www.politico.com/story/2014/06/health-care-electronic-records-107881.html) says government-imposed EHRs are:

• Driving doctors to distraction 

• Igniting nurse protests

• Crushing hospitals under debt

"In short," he writes, "the current generation of electronic health records has about as many fans in medicine as Barack Obama at a tea party convention."

I guess that's  Politco's way of saying "not very many at all."

Doctors forced to use these EHRs say:

• "They slow us down and distract us from taking care of patients."

• "We're basically key-punch operators, transcriptionists having to input the data ourselves. It has essentially tripled the time to complete a medical record."

• "That's why I'm retiring."

• "Before I took notes, wrote what I wanted to say. Now I write and I click. If you just click, the person who reads the record gets no idea of what the patient was going through, your thought process."

• "Anything that in a normal world would take at most two clicks, here it takes four or five."

In fact, doctors and nurses forced to use this technology say far worse (e.g., see my posts on candid clinician feedback at http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html , http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html , http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html , and http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html).

Proponents falsely promised privacy. The real goal of Big Government, Big Data and Big Health was NO privacy. Data is valued as a tool of control and a means to profit. And today, 2.2 million entities today have legal access to your medical records without your consent because of the so-called HIPAA "privacy rule" and the 2009 HITECH Act. In addition, untold numbers of computer thieves, identity thieves and hackers have illegal access.

Not only that, but our data is sold in, in essence, data broker "back alleys" (e.g., see "Health IT Vendors Trafficking in Patient Data?" at http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html ).

Worse, the phenomenon of mismanagement of the "sales" is international in scope (e.g., see "NHS slammed for MAJOR data blunders as scale of patient info sell-off is revealed" at http://www.theregister.co.uk/2014/06/17/nhs_blamed_for_major_data_blunders_with_sale_of_patient_info_to_private_outfits/).

Every doctor and hospital must use EHRs by January 1, 2015 or face financial penalties. This was part of Obama's 2009 Recovery Act, and the foundation of Obamacare. The sheer cost of the mandate has forced many doctors to shut down private clinics and become health system employees, susceptible to being told by outsiders how to practice medicine.

Regarding "crushing hospitals under debt", the EHR "mania" has led medical centers such as the University of Arizona Health System, about to undergo the stresses of mass immigration of South American children no less, to sink $30 million into the red in large part in trying to fix EHR bugs (see my June 2, 2014 post "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" at http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html).

As another example of madness, the mania -- plus bad health IT -- led a  medical system based in Rhode Island to spend $100 million to replace Siemens health IT that caused thousands of potentially harmful prescription errors (http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) with Epic, and in doing so, eroding the cash flow and bond rating of the state's largest health system (http://www.modernhealthcare.com/article/20140606/NEWS/306069948).

Next Ms. Brase reveals a stunning fact about one of the architects of that 2009 Economic Recovery Act:

The arrogance of some EHR supporters is unpardonable. Bob Kocher helped write Obamacare, was trained as a doctor and is employed as a Venrock venture capitalist in health IT, but his credentials are those of a bureaucrat and profiteer (http://www.venrock.com/teammember/bob-kocher/).

Unpardonable arrogance indeed. 

In other words, a speculator and profiteer in the health IT sector helped in the formulation of laws that pushed the technology onto physicians, nurses and hospitals with CMS penalties for non-adopters of "certified" systems.   It would be interesting to know just how far such a potential conflict of interest went in the crafting of the ACA and HITECH itself.

Beyond that issue, this venture cap issues the following perverse statement, as cited by Politico and CCHF:

Per Politico pro eHealth, he says, "The reason so many [computers] are inefficient is that doctors are inefficient. If they redesigned their workflows, computers would work better."

Readers of this blog are familiar with perversity in health IT, but that statement is literally stunning.  It would make for a funny Saturday Night Live or Rowan and Martin's Laugh-In (to us 60's folks) skit if the topic were not so serious.

If they [doctors] redesigned their workflows, computers would work better?

Where, exactly, is the evidence for that assertion?   Exactly how should doctors "redesign" their workflows, considering the poorly bounded, conflicted, highly variable, uncertain, and high-tempo nature of the field? [1]

How can one even have a well-defined and unvarying "workflow" in such a domain that would "make computers work better?"

Answer:  it's impossible.

(Perhaps patients should adjust the unpredictable nature of their illnesses and symptoms to make the computers work better, too?)

What Dr. Kocher seems to turn on its head is the recognition that: 

"The reason so many [computers in healthcare] are inefficient is that they are grossly misdesigned for a domain like medicine.  They are unfit for purpose.  If they [the IT companies] redesigned their entire process in HIT production (from conception, design, implementation, marketing, and support) to be consistent with the needs of the field of clinical medicine and of clinicians, computers would work better." - Silverstein

The reality is that if the healthcare IT industry actually fired its ossified business-IT-oriented leaders (since business computing and clinical computing are two highly different fields, e.g., see http://hcrenewal.blogspot.com/2008/06/business-v-clinical-computing.html), or relegated them to managing accounting systems, and embraced the teaching of 50+ years of Medical Informatics in building good health IT (see definitions of good and bad health IT at http://cci.drexel.edu/faculty/ssilverstein/cases/), then we might actually get significant value and better safety from the technology.

Mr. Kocher, that's an idea to consider. 

As I wrote at that 2008 post on business v. clinical computing:

... The prevalent belief in MIS [management information systems a.k.a. business computing] seems to be that medicine is another area of transactional business subject to conventional modeling by generalists, to be followed by "business process re-engineering" and traditional information systems development processes and methodologies.

However, the belief that one could employ conventional business-oriented "analysis" in the clinical world always seemed to me to be oversimplistic, overoptimistic, and in fact not infrequently harmful to medical practice as a result of the simplistic assumptions. It is a belief that does not perform well even in the conventional business world where significant cost overruns, project difficulties, and project failures are commonplace, let alone in the unforgiving environments of medicine.

My fear is that many in business computing may lack the mental flexibility and capability to understand issues like that, that conflict directly with their linear-flow, business-oriented worldview.

In other words, Mr. Kocher wants doctors to practice according to the computer systems he helped impose, not the doctor's patients. We must never let his agenda for medical practice prevail. State legislatures must act now to restore patient privacy rights and use Tenth Amendment powers to undo the EHR mandate.

Exactly.  It's certainly the simple way to big profits, and injured and dead patients be damned.  Building good health IT is far more resource intensive.

Working to sustain an ethical patient-doctor relationship,

Twila Brase
President and Co-founder

Thank heaven someone is working towards those ends.

Notes:

[1]  Per Medical Informatics researchers Nemeth and Cook's "Hiding in plain sight: What Koppel et al. tell us about healthcare IT", Journal of Biomedical Informatics 38 (2005) 262–263 available at http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf) 

Insurers' diversification creating monopoly power and conflict of interest - quoted in the Washington Post

I am quoted in a Washington Post article today on potential conflicts of interest when medical payers/insurers acquire the firms that hospitals and doctors use to challenge medical payment denials:

 "Health insurers’ push to diversify raises ethical concerns"

Washington Post
Jay Hancock, Sunday, April 29

Like hospitals and doctors everywhere, Banner Health fights a daily battle to get paid by insurance companies and government agencies for the care it delivers.  So the hospital system hired a company called Executive Health Resources to fight back against the likes of Medicare and UnitedHealthcare when they deny claims or pay bills for less than what Banner thinks it is owed.

Fair enough.

But Banner executives began to worry about EHR’s independence when the firm was acquired in 2010 by UnitedHealth Group, UnitedHealthcare’s parent.

Issues can get a bit sticky under such an arrangement.

I put it this way:

Critics call United’s ownership of EHR a troubling conflict of interest that could give it confidential information about rivals as well as patients and limit EHR’s power to demand payment from its much larger corporate sister. “How is that ownership going to affect the mission of a company whose business is to extract more money from payers?” said Scot Silverstein, a physician and specialist in medical software and patient records at Drexel University. “Imagine going to a plaintiff’s lawyer to take your malpractice case and not knowing that plaintiff’s lawyer actually works for the hospital that you’re suing.”

When payers acquire those who would challenge their payment denials, I worry about the consolidation of power being too great for the public good.

As we learn, the relationship is somewhat stealthy:

... There is no mention of EHR’s ownership in the “Corporate Overview” section of its Web site or elsewhere on the site. Nor did the American Hospital Association identify EHR as a United subsidiary in September when it renewed its exclusive endorsement of EHR’s denial-fighting services. EHR pays the hospital association a fee for the endorsement. The group declined to disclose the amount. 

The plot thickens:

Claims consultants such as EHR typically gain access to millions of patient records and confidential contracts between hospitals and insurers, industry officials say. If UnitedHealthcare, United’s insurance wing, gained access to that data, it would obtain “a huge business advantage” over insurance rivals as well as the hospitals, Kofman said.

In today's healthcare business environment, "if" seems to me to be optimistic.

Hancock goes further in the article:

As insurers eager to add revenue streams convert themselves into diversified health-services companies, they often buy traditional business adversaries, including physician groups and hospital consultants such as EHR. They’re also buying technology companies and research firms that serve medical-care providers, raising questions not only about independence but about the privacy of patient information.

A Georgetown professor, formerly a state insurance superintendent, gets to the heart of the matter, using United as but one example:

“I am not convinced that, even with proper disclosure, that an entity owned by United could aggressively advocate against United’s interests,” said Mila Kofman, a Georgetown professor who was Maine’s insurance superintendent.

This factoid is eye-opening:

Appealing claims denials has become a huge, high-tech business, reflected in the more than $1 billion that United reportedly paid for EHR [Executive Health Resources].

You might think there were better things to do with $1 billion besides administrative bloat - such as taking care of patients.

We probably need new laws to catch up with the flurry of M&A's going on in healthcare between payers, the healthcare delivery sector, and the "referees" that mediate between them when disputes arise.

Read the entire article at the WaPo link above.  The examples get even more convoluted.

-- SS

Addendum:

Roy Poses notes:

This appears to be a newly recognized type of conflict of interest that contributes to the concentration of power in the US commercialized health care system.  While many people tout how our health care system is "competitive" and a "free market," it is ever more dominated by a decreasing number of enlarging organizations.  True health care reform would break up health care oligopolies.

-- SS

Wikipedia page on EHR's: ==Disadvantages== material seems to keep disappearing

It's interesting how most of the information below seems to have a hard time "staying put" on the Wikipedia page for "Electronic Health Record" at http://en.wikipedia.org/wiki/Electronic_health_record

The information is presented in a neutral fashion from impeccable sources. Yet several Wikipedia "editors" take issue with it and, rather then editing it or refuting it (and stating their rationale and sources!), they keep deleting it. (The most recent edit history comments follow this "disappearing" information, at the bottom of this post):

==Disadvantages==

===Software quality and usability deficiencies===
EHR software is unregulated, unlike computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.http://en.wikipedia.org/wiki/Validation_%28drug_manufacture%29 Other life-critical industries also have strict software validation and testing standards, e.g., Federal Aviation Administration, NASA.http://www.faa.gov/regulations_policies/advisory_circulars/index.cfm/go/document.information/documentID/1019261http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf.

As a result, EHR software quality and usability is often suboptimal. For example, in "A study of an Enterprise Health information System", March 2011, a Medical Informatics researcher at [[University of Sydney]] in Australia found that a major EHR system for Emergency Departments slated for deployment in the public hospitals of [[New South Wales]] has serious deficiencies in software architecture and fit with clinician workflow. These deficiencies make it difficult to use and unreliable in terms of data integrity and loss, in one of the most demanding of clinical environments .http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

The [[Healthcare Information and Management Systems Society]] (HIMSS), a very large U.S. healthcare IT industry trade group, observed that EHR adoption rates "have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available."http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf

Serious reliability and usability problems with the U.S. Department of Defense’s [[AHLTA]] EHR system have been reported to the Congress.http://www.usmedicine.com/articles/electronic-records-system-unreliable-difficult-to-use-service-officials-tell-congress.html

The U.S. [[National Institute of Standards and Technology]] (NIST) issued a Sept. 2011 report on deficient usability of current EHR systems, with recommendations for usability evaluation, testing and validation.http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf

===Unintended adverse consequences===
EHRs can introduce new unintended consequences, compared to paper records, and adverse outcomes, including patient injury and death, according to regualtory and governmental agencies, researchers, and others; for example, in an internal 2009 FDA memorandumhttp://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf of Feb. 23, 2010 obtained and released by the Huffington Post Investigative Fundhttp://web.archive.org/web/20110425002322/http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight, EHR-related medical errors are categorized as: errors of commission (EOC), errors of omission or transmission (EOT), errors in data analysis (EDA), and incompatibility between multi-vendor software applications or systems (ISMA).

The [[National Health Service]] (NHS) in the UK reports specific examples of EHR-caused patient harms in a 2009 document on guidance on the management of clinical risk relating to the deployment and use of health software, Annex A "Examples of potential harm presented by health software."http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf.

Also, in "Research in Ambulatory Patient Safety 2000–2010: A 10-year review", Dec. 2011http://www.ama-assn.org/resources/doc/ethics/research-ambulatory-patient-safety.pdf, the American Medical Association reports:

:While health IT may confer benefits, some research has also suggested that health IT systems can create new issues or exacerbate existing problems. Wachter noted that, “[i]n both professional and lay publications, concerns have been raised that today’s electronic health records promote the copying and pasting of clinical information, instead of its thoughtful analysis; foster a focus on completing computerized checklists and templates rather than detailed probing of the patient’s history, and support less thoughtful diagnostic reasoning and more automatic behavior on the part of caregivers." Research indicates that a great deal depends on the design of the health information technology system, with poorly designed systems contributing to instances of errors (Ash et al). Where user interface designs are cumbersome to use and do not fit into the clinician’s natural work context, some have noted the potential for “cognitive overload,” among other reactions, and ultimately the possibility of increasing errors in data entry and retrieval as well as errors in the process of communication and coordination (Ash et al, Singh et al).

In the U.S., FDA's MAUDE (Manufacturer and User Facility Device Experience) databasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMreveals many reported EHR problems, some of which could result in patient injury or death http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html. Both FDA (in the 2010 memo referenced above) and the [[Institute of Medicine]] of the National Academies in a 2011 study http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF reveal that EHR-related injuries and deaths are real, but the true extent is likely understated, they report, due to numerous factors impeding diffusion of knowledge such as contractual gag and hold harmless clauseshttp://jama.ama-assn.org/content/301/12/1276.extract and lack of familiarity by users of where to report EHR-related adverse events (per aforementioned 2009 FDA internal memo). A Medical Informatics researcher in the U.S. has compiled a well-referenced teaching site that covers unintended consequences of EHRs, health IT project difficulties and failure and related issues{{cite web | last=Silverstein| first=Scot| year=2012 | url=http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ | title=Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties| publisher=Drexel University |accessdate=2012-01-26}}.

The literature is conflicting on benefits and harms of EHRs http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html, and as in the Jan. 2009 U.S. National Academies study "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS", EHR's ultimate success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572

===Regulatory controversy===
FDA's Jeffrey Shuren, MD JD, Director of the [[Center for Devices and Radiological Health]] (CDRH), has explicitly declared EHRs are a medical device.http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf So has the [[Medical Products Agency (Sweden)]]; Swedish law for medical devices is based on EU Directives.http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf. In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjectshttp://ohsr.od.nih.gov/guidelines/index.html and the World Medical Association Declaration Of Helsinkihttp://ohsr.od.nih.gov/guidelines/helsinki.html restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown. As in the 2011 U.S. [[Institute of Medicine]] study "Health IT and Patient Safety: Building Safer Systems for Better Care"http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, there are calls for formal governmental regulation of the technology.

The edit-history comments are quite interesting, where a poster who uses the ID "Barek" keeps deleting all or most of the information on EHR disadvantages, despite indications the material is impeccably sourced and does not draw its own conclusions. Read from bottom to top:

17:29, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (67,826 bytes) (please discuss on talk page, as you are approaching WP:3RR)

17:28, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,232 bytes) (clarifying that information comes from the cited sources.)

17:26, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (→Unintended adverse consequences)

17:24, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,151 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:23, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:18, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (Undid revision 473542684 by Barek (talk). Barek may have a conflict of interest regarding exposure of health IT difficulties.)

17:14, 27 January 2012‎ Barek (talk | contribs)‎ m (67,826 bytes) (Reverted edits by InformaticsMD (talk) to last version by Barek)

17:14, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (→Regulatory controversy)

17:12, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,217 bytes) (The added information is factual, well-referenced from impeccable sources, and does not draw conclusions.)

17:08, 27 January 2012‎ Barek (talk | contribs)‎ (67,826 bytes) (→Disadvantages: restore some content after purging WP:SYNTH material)

17:06, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (65,826 bytes) (rv per WP:SYNTH)

17:01, 27 January 2012‎ 108.16.62.235 (talk)‎ (76,341 bytes) (Undid revision 473539844 by Barek (talk))

16:57, 27 January 2012‎ Barek (talk | contribs)‎ (65,826 bytes) (rv - some of that content is usable - but most is pure WP:SYNTH, attempting to draw conclusions rather than simply stating what's in the sources - requires a total re-write to be encyclopedic)

... 20:22, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,058 bytes) (→Unintended Adverse Consequences: actually, remove whole section - BAD HANDWRITING can result in patient injury and death)

20:21, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,860 bytes) (→Unintended Adverse Consequences: If it's unknown, we don't need to report it. If it's not a RS, we don't need to report its conclusions. And "a researcher says" isn't notable enough to mention without establishing authority in the subject) (undo)

I note that the logically fallacious "Bad handwriting can cause patient injury and death, so remove whole EHR Unintended Adverse Consequences section" and "if it's unknown, we don't need to report it" [regarding the referenced FDA and IOM observations that the true extent of EHR adverse consequences is unknown -- which is on its face a matter critical to public health and policy - ed.], coming from an editor who ironically calls him/herself "Sarek of Vulcan", offers a prime example of how the utopian concept of tapping "community wisdom" can fall flat on its face.

WP:SYNTH is Wikipedia-talk for "Synthesis of published material that advances a position", i.e., "drawing conclusions." Apparently, when it comes to EHR, citing the work of governmental regulatory and healthcare agencies, expert researchers, etc. is "drawing conclusions."

Wikipedia is essentially open to all, including the HIT industry and its pundits.

It is possible that the Wikipedia editors who keep deleting the material could have some sort of conflict of interest. COI could cause them to find easily-verifiable information from impeccable sources on the Wikipedia EHR page (viewed 22924 times in the last 30 days as of this morning) that refutes common cybernetic legends to be "inconvenient." We've certainly seen that type of person before (link).

This affair may also be another example of the "anechoic effect", the notion we discuss often on this blog that certain topics in medicine and health care 'just aren't talked about', in action.

The 'disadvantages' material, revised, will be re-posted again soon, after my being blocked (for 'reverting', i.e., restoring the material three times in 24 hrs.) expires tomorrow. It will be revised to have as neutral a tone as possible, with exact page numbers where possible, in accordance with written Wikipedia examples. If the additions still disappear, that will be revelatory.

-- SS

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be:

A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.

The site is entitled "Doctors Helping Doctors Transform Health Care" and is at this link. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "transform how, and into what, exactly?" I presume "transform" means, in part, to reduce risk and improve safety and outcomes - while protecting patient and physician rights.)

The site has a significant number of people on their advisory board (link), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest.

According to one of the principals, Peter Basch, MD, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, on funding:

A Few Words About Our Supporters

It takes resources to create and maintain this site, to make the work of Doctors Helping Doctors possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.

To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, William Bria, III, MD, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL.

Dr. Basch's writing has appeared at Healthcare Renewal before, such as at the Jan. 2009 post "Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health."

In the new site, Dr. Basch states that:

As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—and uncritical cheerleading—which we have also heard—are equally unhelpful.

We see physician “extremism” essentially marginalizing what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.

While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics.

I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as here).

There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see this post), that is unregulated, into life-critical domains such as medicine without explicit acknowledgement of experimentation. Human subjects experimentation requires, of course, explicit informed consent under the many guidelines formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks.

Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism.

For instance, health IT can be inherently defective and/or mission hostile (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at:

• "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death";

• "Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands";

• "FDA MAUDE Database: Patient Outcome - Death" and "FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects";

• "ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety";

• "Bad Health Informatics Can Kill" [European Federation for Medical Informatics];
  

• "A Study of an Enterprise Health information System" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];

• "Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A];
  

• and a personal account "A Diary of EHR-Initiated Tragedy."

Not even including privacy and confidentiality issues (see this query link on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not?

Are not these issues and the issue of the lack of a culture of safety in the health IT field at least as important, if not more important for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?"

(I note that the "negative reports are mere anecdotes" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things", that those making that argument need to attend revision courses in research methodology and risk management.)

In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears at this link and is awaiting moderation.

The comment's remaining online would be a sign that the site is not another attempt to "control the channel", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" while not sacrificing patients as unconsenting test subjects of unregulated, experimental software-based medical devices in the process.

S Silverstein MD says:

December 17, 2011 at 10:29 pm

Doctors,

One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist).

I do not see such information here yet.

I do expect some such information will follow.

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 Information Science and Technology
3141 Chestnut St., Philadelphia, PA 19104-2875

Email: sms88 AT drexel DOT e-d-u
Bio: http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm
Common Examples of Healthcare IT Difficulties: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/

Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"

It is my hope the comment stays, and receives a reasoned reply.

-- SS

Dec. 23, 2011 addendum:

My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare."

-- SS

Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short

This morning NIH Director Dr. Francis Collins announced revisions to the existing 1995 regulations on objectivity in research that is funded by the Public Health Service. The focus is on significant financial interests (SFI) and on financial conflicts of interest (FCOI). The regulations illustrate the 3-way dance involving academic institutions (the grantees), NIH (the grantor) and academic scientists (the investigators). Thanks to Senator Grassley (R-Iowa) and his investigator Paul Thacker, headlined revelations in recent years about unacceptable management of FCOI at places like Stanford (Alan Schatzberg), Emory (Charles Nemeroff) and Harvard (Joseph Biederman) forced these revisions of the NIH regulations.

The general initial reaction to the new rules has been critical – here and here, for instance. Many stakeholders had urged the NIH to require that institutions make the disclosed FCOI of their investigators available on a public website. Dr. Collins had intimated that we could expect to see this change, so there is consternation that it somehow became derailed by institutional lobbying in recent months. The stated concern was that institutions would feel burdened by the need to maintain these data bases. Instead, if citizens wish to inquire about FCOI involving PHS-derived research funding, they will need to write to the institution, which is obliged to respond within 5 days. That’s not exactly user friendly. POGO today made the smart suggestion that the data could easily be attached to information about awarded funds on the NIH RePORTER website, that already exists.

A second failing is that the revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident several times on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees.

Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated. Here is the relevant section of today’s announcement (page 89):

We did, however, agree with one respondent that it would be helpful to clarify, in the grants context in particular, that institutional sanctions against an Investigator can travel with the Investigator upon his or her transfer to another Institution. Specifically, we have revised 42 CFR 50.606, paragraph (a), as follows: “If the failure of an Investigator to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. The PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.”

This revision is intended to reference the range of options for the PHS Awarding Component to consider, depending on the specific circumstances at issue. For example, PHS may decide to initiate government-wide suspension or debarment of the Investigator under 2 CFR Part 376; or to use enforcement measures under 45 CFR 74.62, e.g., perhaps to make the approval of a transfer contingent upon the former Institution’s disclosure of the corrective action- including the specific sanctions against the Investigator- to the new Institution; and/or to use special award conditions under 45 CFR 74.14, e.g., perhaps to make the new Institution agree to take the same or similar action against that Investigator or explain to the PHS Awarding Component in writing why such action was not taken and what alternative measures will be used to ensure compliance.

What’s wrong here? Everything is optional; everything is discretionary; everything is contextual – that is a formula for NIH and the academic institutions to just look the other way. And if a Nemeroff decides just to relocate without transferring a grant then he is free to start reapplying again right away. Miami would not be required to continue applying the Emory sanction banning him for 2 years from involvement in federal grants. The PHS Awarding Component (NIMH in this case) may or may not get involved, or it may pass the buck to the new institution. So what has changed? If it is left up to compromised federal bureaucrats like Thomas Insel, and institutional administrators like Pascal Goldschmidt at Miami, then nothing has changed. It's business as usual, folks.

Dr. Collins, you have not done what you set out to do. Too bad.

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE?

Ghostwriting Charges and Stonewalling at the American Psychiatric Association

The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.

The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.

The coup de grâce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.

Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.

Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.

For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.

Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

JAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.

Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members.

Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look here and here for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed.

Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that?

In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. Quis custodiet ipsos custodes?

Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (query link).

One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry.

One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review" (BMJ 2010;340:c1344).

Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the Philadelphia Inquirer:

"We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.

From the BMJ article itself, free full text available as of this writing at link above:

For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.

The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing.

Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's.

As to results (see the full article for statistical details I am omitting here):

Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.

While causality is not proven, these results are still stunning. Per the Inquirer's summary:

... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.

Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.

The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy).

The authors observe that:

In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest.

Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements:

Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.]

One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist.

... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]

So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue.

Finally, the pharmaceutical company's view, also published in the Inquirer article cited above:

A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site.

"It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure."

"Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view.

The Mayo researchers wisely conclude:

Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.

Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers.

We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues.

These practices also simply need to be abolished, for as I have written before on these pages ("Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already.

-- SS