There They Go Again - the New England Medical Journal Publishes another Rant, this Time about Power Morcellation

In 2015, we noted (here and here) that the New England Journal of Medicine seemed to have been reduced to publishing rants about "pharmascolds" who are paranoid about conflicts of interest. Now there they go again....

Background

The sad story about the risks of power morcellation for the treatment of fibroids has received considerable media attention.  The state of play through July, 2014 was described in a series of articles in the Cancer Letter of July 4, 2014. (Look here.)

Uterine fibroids are a common affliction of women.  Their preferred surgical management had changed from open surgery to minimally invasive surgery, sometimes robotically performed, and often incorporating a device called a power morcellator to pulverize the fibroids, allowing the use of small incision.  However, after a patient at the Brigham and Womens' Hospital (BWH) in Boston, part of the Partners Healthcare system, was found to have disseminated sarcoma post power morcellation, most likely because the machine spread tumor cells throughout her abdomen, the US Food and Drug Administration (FDA) issued an advisory against using the procedure morcellation, and despite some controversy, the procedure is now uncommonly used.

The patient so severely affected was Dr Amy Reed, an anesthesiologist at the BWH.  Her husband, a cardiothoracic surgeon at BWH, launched a campaign to reduce the use of power morcellation.  His pursuit of this campaign underlined an important part of the history, 

The use of power morcellation was effectively allowed by the FDA in the absence of any controlled trials meant to assess its safety or efficacy in this context.  The device was deemed moderate risk and approved through the 510(k) process because it appeared similar to previously allowed devices, even though older devices were not used to remove fibroids.  The Cancer Letter quoted Dr David Challoner, who was on a relevant Institute of Medicine (IOM) committee, saying allowing the device on the market was 

one more example of the clearance of a device for a use, not approval, based on predicates already in the market, that is, prior morcellators for other uses

The New England Journal of Medicine Weighs In - with a Special Pleading

Once again, NEJM national correspondent Dr Lisa Rosenbaum had a contrarian view(1).  As we discussed here and here, last year Dr Rosenbaum wrote three commentaries suggesting the importance of conflicts of interest in health care had been overblown, especially with respect to medical journals.

This time, she argued that the FDA overreacted to the tragic case of  Dr Amy Reed. In particular, she was afraid that the risks of power morcellation were exaggerated, and based on poor quality data,

Several experts argued that these risk estimates were too high and that it was riskier to expose 100,000 or so women per year to open procedures rather than laparoscopic ones. Since the rarity of LMS precludes a randomized trial, however, risk estimates had to be based primarily on retrospective case series of varying rigor. Some studies were poorly stratified for risk factors such as age, and others spanned decades during which diagnostic criteria for LMS had changed.

Dr Rosenbaum failed to mention that the lack of good data about the risks of power morcellation stemmed from the lack of any large, well designed randomized controlled trials done to assess its benefits and harms. Of course, since the device's use was allowed by the FDA 510(k) process without any requirement for trial data, there was no incentive for device companies, at least, to do such trials.

Nonetheless, Dr Rosenbaum also argued the benefits of power morcellation were downplayed. 

the benefits of morcellation are largely invisible and thus 'unavailable.' Who sees the women who undergo a minimally invasive procedure, recover quickly, and avoid losing income? What does a pulmonary embolus, a wound infection, or a hemorrhage that didn’t happen look like? You can’t post pictures of these nonevents on social media. But their nonoccurrence is why we ought to be celebrating.

A March 18, 2016 article asked my opinion about Dr Rosenbaum's use of the clinical evidence.

'She talks about the data concerning the possible harms of power morcellation and argues that that data comes from relatively low-quality studies, not randomized, controlled trials, and that it is hard to tell the actual rate of harms, in particular, the dissemination of cancer. On the other hand, Dr. Rosenbaum implies that the benefits of power morcellation are well known.'

'She writes initially that power morcellation allows the treatment of fibroids to be ‘done more efficiently and effectively,’ she later implies that power morcellation is less invasive, leads to quicker recovery, avoids income loss, and furthermore, reduces the likelihood of pulmonary embolus, wound infection, or hemorrhage.'

'However, she doesn’t provide any data about these ostensible benefits. A quick search suggested that there are no good randomized, controlled trials that assessed benefits. Her argument that we have abandoned a beneficial treatment based on poor quality and perhaps exaggerated the data about its harms—that does not seem to be supported by any clear data about its benefits.'

I rendered that opinion on March 18 before I read a Cochrane Collaboration review of minimally invasive surgery versus open surgery for fibroids(2).  However, that review does not seem to contradict my statements above.  The review included some patients who were treated using power morcellation, but apparently did not find any studies that assessed patients treated only with power morcellation with those treated only with an alternative.  Even so, it only included nine studies that enrolled a total of 808 patients.  Thus, I think it is reasonable to say that there have not been any large, well-done randomized controlled trials of power morcellation versus other treatments of fibroids.  Even so, while the review found some advantages for minimally invasive surgery versus open surgery in terms of short-term post-operative pain and length of hospital stay, it did not address pulmonary embolus, wound infection, or hemorrhage directly.  So while Dr Rosenbaum was right to say that the evidence from clinical research about the magnitude and nature of harms of power morcellation was relatively weak, the evidence about its benefits is also weak. Thus, Dr Rosenbaum's argument that the harms have been exaggerated while the benefits were overlooked was based on a logical fallacy, special pleading. 

This special pleading seemed the basis for her claim that

women may suffer more from its [power morcellation's] disuse.

So, as I was quoted by the Cancer Letter,

'The NEJM is perhaps the most prestigious, most highly regarded English-language medical journal in the world,' Poses said. 'It is, in many cases, viewed as the standard for scholarly medical journals. I am a bit surprised that it published a commentary by its own national correspondent that appears to make an argument—about benefits and harms of treatment and policymaking about treatment—that does not have a clear discussion of the data that support or fail to support either the benefits or the harms of the treatment.'

More Arguments, Less Justification

Dr Rosenbaum insisted that her concerns were about the question,

How do you use data to clarify tough trade-offs when the most compelling narratives paint evidence-based reasoning itself as an anathema?

However, she did not demonstrate an approach to policy making on power morcellation that was more evidence-based than what has transpired so far.

In addition, Dr Rosenbaum decried challenges to health care innovation from "the power of tragic stories," and the title of her commentary ("N-of-1 policymaking") suggested that the the FDA approach to power morcellation was based on a single tragic story.  Yet an FDA spokesperson insisted in the March 18, 2016 Cancer Letter article,

The FDA evaluated the available data at the time and determined that it was of sufficient quality and reliability to support our November 14, 2014 decision.

Furthermore, Dr Rosenbaum expressed concerns that power morcellation met its "demise" because of unwarranted concerns about the "greedy corporation," "medicine's corruption," and "industry greed."   Yet she ignored arguments that these concerns were not unreasonable.    

First, the commentary ignored claims that power morcellation procedures were very lucrative, e.g., those in the 2014 Cancer Letter article

'This is a very lucrative procedure.'  [Dr] Noorchashm, [Dr Reed's husband] said.  'The procedure itself bills $30,000 to $50,000, depending on the center.'

Nor did she argue against the assertion in the same article that device companies used political influence to promote their very expensive product,

There is a very strong pressure from the device industry to get into the market quickly.

The device companies have been able to make [the 510(k) process that allowed power morcellation] survive politically over the ensuing 40 years.

Also, Dr Rosenbaum's NEJM commentary failed to counter the assertion by Dr Noorchashm that the device manufacturers concealed the risks of power morcellation.

Device manufacturers clearly knew of the cancer risk.  You can see warnings about malignant tumors in the Ethicon and Karl Storz user manuals.  Clearly, their lawyers had warned them to put them there to avoid liability.  The bottom line is that these manufacturers knew of this hazard, but neither reported it back to the FDA, as would have been the safe and responsible thing to do.(3) 

Finally, according to the March 18, 2016 Cancer Letter article, while Dr Reed has apparently sued the BWH, and Dr Rosenbaum admitted she is on "faculty" at the BWH, neither she, the NEJM, nor the BWH will say whether she is currently being paid by the BWH.  Particularly,

the hospital declined to provide information on Rosenbaum's title and whether she is a full-time faculty member, citing personnel policies.

My response (in the Cancer Letter article) was

'I can see that the hospital would not want to reveal her salary, if in fact she has one, and that has privacy implications,' Poses said. 'But I don’t understand why the hospital would not be able to simply tell you whether or not she is employed there and in what capacity.'

Thus, the latest commentary in the New England Journal of Medicine by National Correspondent Dr Lisa Rosenbaum used special pleading to argue for an expensive medical device with dubious benefits but which no more dubious evidence suggests may cause cancer.  The commentary also decried the device's critics as unreasonably concerned about "greed" and "corruption," even though the device is clearly expensive, there are at least creditable allegations that the device makers used political influence to promote it and concealed its risks, and ironically the commentary itself obfuscated whether Dr Rosenbaum has a major financial relationship to the hospital that is being sued in connection with use of that device there.

Thus, this latest New England Journal of Medicinearticle, like those by the same author in the same journal which we have discussed before (here and here), seems more like a rant in a political blog than a scholarly article in the US' and perhaps the world's most prestigious scholarly medical journal.  What is going on at the NEJM? What has happened to its editorial standards?  Why should it continue to inspire such trust?    

ADDENDUM (22 March, 2016) - See also comments in the 1BoringOldMan blog. 


References

1.  Rosenbaum L.  N-of-1 policymaking - tragedy, trade-offs, and the demise of morcellation.  N Engl J Med 2016; 374: 986-990.  Link here.
2.  Chittawar PB, Franik S, Pouwer AW et al.  Minimally invasive surgical techniques versus open myomectomy for uterine fibroids. Cochrane Library 2014. Link here.
3.  Dyer O. US surgeon who campaigned against potentially dangerous device receives legal threat.  Brit Med J 2014; 349: g5577.  

What Revolving Door? - An Unprecedented Endorsement of a Political Appointment by the "Gold Standard" Medical Journal

An Unprecedented Endorsement 

It's deja vu all over again.  In the spring of 2015, the New England Journal, the most prestigious US medical journal, published a remarkable series of opinion pieces extrolling physician-industry collaborations, and minimizing the significance of resulting conflicts of interest.  More remarkable was the extent that the articles' argument were bolstered by logical fallacies (look here).

Doubling down, the New England Journal of Medicine appeared to make its first ever endorsement of a nominee for federal office.  On October 28, 2015, the NEJM published an editorial with the almost campaign slogan like title, "Califf for the FDA," which enthusiastically endorsed the current presidential nominee to be Commissioner of the US Food and Drug Administration (FDA). (1)   It began, [with italics added for emphasis]

Robert M. Califf, M.D., has been nominated to be the next head of the Food and Drug Administration (FDA); he currently serves as Deputy Commissioner for the Office of Medical Products and Tobacco. We think his confirmation as commissioner should proceed as quickly as possible. Because the FDA oversees the safety and, in some spheres, the efficacy of products that constitute about 25% of our economy, the country needs a strong and experienced leader who can keep the FDA focused on its mission.

And the editorial concluded,

Califf's experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpased qualifications for the post of commissioner of the FDA; we strongly endorse his nomination and urge the Senate to act favorably on it. 

I have never seen this journal, known primarily for publishing research and scholarly opinion on medicine and health care, publicly render an opinion about a nomination for a federal position, let alone such an enthusiastic one.  A quick search of the journal revealed that it had taken no position and made no comment about the nominations of the last three US FDA Commissioners, (Dr Margaret Hamburg, Dr Andrew von Eschenbach, Dr Lester Crawford, and Dr Mark McClellan, look here) who were nominated by one Democratic and one Republican President.

Dismissing Concerns about Conflicts of Interest

This fervid endorsement came in the face of some controversy about the nomination, particularly about Dr Califf's previous ties to industry (see this post ).  He has participated in many industry sponsored clinical research projects.  For example, a 2013 JAMA disclosure statement included 13 commercial research sponsors of his work.  It also noted his consultative relationships with 32 commercial firms.  We discovered he also had a "board level" conflict of interest, having been a director of Portola Pharmaceuticals, for which he received over $250,000 in 2014 (see this proxy statement).  He also had been paid for "educational activities" in previous years, possibly including "drug talks," at least per one blogger.  So in my humble opinion, the nomination of Dr Califf could potentially become one of the most significant health care revolving door cases to affect US government.


Such consideration may have influenced Senator Bernie Sanders (I - Vermont), who is currently running for President.  In early October he announced he would oppose the Califf nomination.

Furthermore, since our post but before the publication of the NEJM editorial, there have been new revelations.   Dr Califf twithdrew as authors from several papers that had been accepted for publication, seemingly violating norms for declaring authorship of scholarly works, (see the Boston Globe here).   Dr Califf was revealed to have been a board member of and consultant to Faculty Connection LLC, which advises academic researchers "who want to work with industry" about regulatory submissions (see Intercept.com here)

Yet the Editor of the New England Journal of Medicine dismissed concerns about Dr Califf's industry relationships,

a few concerns have been expressed about his associations with industry, and these concerns may have caused some to withhold support for his nomination.

Like Califf, we believe that our actions should be driven by data, not innuendo. Since 2005, Califf has reported, as an investigator, the outcomes of seven clinical trials sponsored solely by industry in primary publications in major general medical journals. Of these trials, four had a negative outcome (i.e., not favoring the intervention), two favored the intervention, and one, with a factorial design, had a mixed outcome. Given this performance, it is impossible to argue that Califf has a pro-industry bias.

This opinion may yet carry the day.  The New York Times reported that

Dr Robert M Califf ... coasted through a confirmation hearing on Tuesday, with  most members of a Senate committee - including some who have been skeptical about his ties to the pharmaceutical industry - seeming set to support his candidacy.

This occurred despite one more major revelation that appeared since the editorial was published, but before the hearing.  A large pharmaceutical company clinical trial which Dr Califf ran had been criticized as biased in favor of the company's drug by the FDA's own staff and consultants. (see POGO here).  And it occurred despite calls by various organizations for the nomination to be turned down, including by Public Citizen and the AIDS Healthcare Foundation (see Medscape here).

Missing the Main Point

However, the NEJM editorial seemed to miss the main point.  It revolved around the claim that

It is impossible to argue that Califf has a pro-industry bias.

This was based apparently on an informal evaluation by Dr Drazen of seven of Dr Califf's 1200 publications.  So at best this was about the question of pro-industry bias in research publications. 

However, the controversy is about Dr Califf's nomination as the head of the US government agency that oversees the pharmaceutical, device and biotechnology industries, among others, and tries to assure the safety and effectiveness of drugs, biologics and medical devices, among other responsibilities.  The overriding issue is about the risk that his decision making in these capacities could be biased.  The real issue is the revolving door, not bias in research.

As we have repeated very recently, the revolving door can be veiwed as a species of conflict of interest.   Government officials who can look forward to extremely lucrative employment in health care industry may be much more inclined to seem friendly to the industry while in office.  Government officials who were previously paid by industry, and who benefited from financial interactions with industry, are likely to maintain their industry mindset and be mindful of their industry friends.  But the concern here is not that this risks biasing future research.  The risk is that a person who previously enjoyed close ties, including close financial ties to industry is at risk of putting the interests of industry over those of citizens and patients while running a US government agency charged with regulating that industry and protecting the health and safety of those citizens and patients.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

  Dr Drazen's editorial never directly addressed that issue.  It is one that should still be a concern.

Mission-Hostile Management?

Finally, the effect of the Califf nomination on the FDA has generated considerable public comment.  The effect of the New England Journal of Medicine's unprecendented editorial endorsement of the nomination has generated almost no discussion.  Only on the 1BoringOldMan blog was there note of the past industry ties of the current NEJM editor inspired their own controversies, and asked "since when is the editorship of the NEJM a position from which to weigh in on such matters?" (look here).

Using the editorship to so weigh in could not only obfuscate the debate about the nomination.  It could threaten the mission of a proud medical institution. The NEJM claims a

reputation as the 'gold standard' for quality biomedical research and for the best practices in clinical medicine.

It claims its editorials are

thoughtful, carefully reasoned analyses and interpretations [which] help you crystallize your own opinions on current topics and findings

Yet the blanket and unprecedented endorsement of the current FDA nominee appears otherwise.  We have previously argued that the earlier NEJM opinion pieces on conflicts of interest were based on logical fallacies more than "thoughtful, carefully reasoned analyses and interpretation."  In the Editor's apparent haste to defend industry-physician relationships, he risks the reputation and mission of once what was really a gold standard.

 Reference

1.  Drazen JM. Califf for the FDA.  N Engl J Med 2015;  DOI: 10.1056/NEJMe1513828 (link here)  

Say It Ain't So, Again - a "Push Poll" to Minimize the Hazards of Conflicts of Interest ...in the New England Journal of Medicine?

The New England Journal of Medicine recently published a remarkable series of apologiae for conflicts of interest,(1-4) about which we have published three posts, here, here, and here.  Just to ice the cake, the NEJM also set up a reader poll on the subject. Its introduction stated,

we invite you to put yourself in the role of editor and help us decide about the suitability of three hypothetical potential authors of review articles for the Journal.

However, as noted first in a post on the HealthNewsReview.org blog, the poll had a curious design. 

Each of the three hypothetical experts has some type of financial arrangement with the pharmaceutical industry – either royalty payments, speaking fees, or commercially supported research at a university that covers everything except the researcher’s salary.

Noticeably absent was a 'Case #4' describing a potential author with no conflict of interest. 

IMHO, this seems like a biased survey design.  By failing to incorporate a questions about an unconflicted author, the numeric results of the poll could not show whether those answering it would actually favor authors without conflicts of interest.  Of course, the whole thrust of the three commentary(2-4) plus one editorial(1) NEJM series was that concerns about such conflicts are overblown.

Nonetheless, the poll allowed for comments, and as the blog post showed, this bias did not escape notice.  One commentator, Dr David Newman, wrote

The only reason to choose any of the individuals in these cases would be if there were no available alternatives.

This survey bias did not escape Dr Josh Farkas, who wrote this in a PulmCrit blog post,

Perhaps the most interesting component of the media campaign is the reader poll about the adequacy of various hypothetical authors for a review article.  Three potential authors are described, all of whom have significant COIs.  The design of this poll itself is biased, by presenting no authors without COIs.  A more transparent approach might be to simply ask readers 'do you think review article authors should be allowed to have COIs?'

Thus, the NEJM conflict of interest poll appears to be not an attempt at unbiased data collection, but a "push poll."  A "push poll," per Wikipedia, is:

an interactive marketing technique, most commonly employed during political campaigning, in which an individual or organization attempts to influence or alter the view of voters under the guise of conducting a poll.

By prominently publishing a poll with such a biased design, the NEJM has further supported my argument that its current editors are engaging in polemics rather than scholarly debate about the very important issue of conflicts of interest in medicine and health care.  Perhaps the current NEJM editors should consider joining the blogsphere in which polemics abound, while leaving the serious business of scholarly journal editing to those who are more dispassionate.   

References
1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.

BLOGSCAN - New England Journal of Medicine Scoffs at "Pharmascolds"

The venerable New England Journal of Medicine has now published an editorial,(1) and two commentaries(2-3), with one more promised, hailing physician industry "partnership," as per NEJM editor Jeffrey Drazen,(1) and deploring the "pharmascolds,"(3) who might question the glorious innovations that could arise when industry pays academic and practicing physicians.   

In a tweet, Dr Harlan Krumholz said he was "shocked" that a NEJM commentary would "give credence to the 'pharmascold' narrative.  

So far, the only more detailed questions about this new direction for the Journal came in a guest blog by Dr Susan Molchan in the HealthNewsReview blog, which responded only to the editorial(1) and the first commentary(2).  Dr Molchan wrote, 

Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs. She asks, “Have stories about industry greed so permeated our collective consciousness that we have forgotten that industry and physicians often share a mission — to fight disease?” Is Dr. Rosenbaum’s consciousness so clouded as to think that pharmaceutical companies don’t exist first and foremost to make money? That their primary responsibility is not to their shareholders?  It’s true that a means to this end is fighting disease, (including new “diseases,” tailored to one’s drug), but this should not be confused or conflated with the primary mission of (hopefully most) physicians.

I and many others suggest that the 'stories about industry greed' have not permeated enough, and that this problem has polluted much of medical research and medical practice, to the point where trust of the medical research enterprise has been eroded....

The airtime the NEJM is giving this issue, including publishing three - count them - strongly opinionated but hardly journalistic commentaries by their ostensible"national correspondent," suggest a major push against the "pharmascolds."  Again, note this this inflammatory and ad hominem term was used in a supposedly serious article on "Medicine and Society."  I strongly doubt we have heard the last of this.  Stay tuned. 

ADDENDUM (20 May, 2015) - See also comments by Mickey on the 1BoringOldMan blog.  

References
1.  Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854.  Link here.
2.  Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015;  372:1860-1864.  Link here. 
3.  Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here. 

Twilight of the Anechoic Effect? - New England Journal of Medicine Article Discusses Previously Taboo Topic of Bad Corporate Health Care Leadership

We have often complained of the anechoic effect, that the issues we discuss on Health Care Renewal often do not seem to be considered topics of polite conversation.  Any discussion that might question the brilliance, integrity, dedication, or selflessness of the leaders of health care organizations seems particularly taboo. 

So a major aim of this blog has been to discuss the numerous publicly available examples of leadership that is ill-informed, uncaring about or hostile to the values of health care professionals, incompetent, self-interested, conflicted, or outright corrupt, and of governance that lacks accountability, transparency, integrity, honesty, or ethics.  We have postulated that such problems with leadership and governance are not only causes, but the major causes of the increasing dysfunction of our health care system.  That discussing these issues is simply not done in many contexts, including academic health care, medical and health care journals, and health policy fora has only accelerated health care dysfunction.

The New England Journal on Punishing Health Care Fraud

Therefore, I note with some surprise that the New England Journal of Medicine just published an article (online first) that implicitly challenged the leadership of some large health care organizations. [Outterson K. Punishing health care fraud - is the GSK settlement sufficient.  N Engl J Med 2012; 367: 1082 - 1085.  Link here.]

The article summarized the record settling legal settlement agreed to by GlaxoSmithKline (see this post).  It noted that the company pleaded guilty to three criminal charges.  It then noted that while this was the largest recent legal settlement by a pharmaceutical company, "it would be a mistake to assume that GSK was an outlier in the global pharmaceutical and medical-device industries. Indeed, many of the major companies have settled with the Department of Justice in recent years."  It included a table of the largest pharmaceutical company settlements with the US government from 2009 to now.

Based on this background, the article dared to question whether such settlements deter bad behavior:

But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies' revenue. Companies might well view such fines as merely a cost of doing business — a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms' past misdeeds.

Even more daring was its challenge to top executives of pharmaceutical corporations,

One partial solution would be to impose penalties on corporate executives rather than just the company as a whole. Boston whistleblower attorney Robert M. Thomas, Jr., embraces this approach: 'GSK is a recidivist. How can a company commit a $1 billion crime and no individual is held responsible?'

A Taboo Broken

Having blogged on Health Care Renewal for nearly eight years, I recall very few, if any instances in which leaders of health care organizations were described as deserving punishment, or perhaps even guilty of crimes within large circulation medical journals, and within the New England Journal of Medicine, the most prominent US journal in particular. While discussion of misbehavior within health care organizations has slowly been seeping into the medical and health care literature, delicate phrasing has often been employed that leaves unclear whether top executives have any accountability for this behavior. (For example, while the Lancet editorial on the GSK settlement condemned "GSK's fraud," accused GSK of "actively encouraging off-label prescription," and asserted that "GSK and other drug companies have come adrift from standards of the societies they seek to serve," it never said anything about GSK's leaders or whether they in paticular had anything to do with the company's bad behavior. [Anon. Moral decaly at GSK reaps record US$# billion fine. Lancet 2010; 380: 2. Link here.])

So it is a big step for the NEJM to publish an article that suggests corporate executives might deserve penalties. I hope that this publication might lead to a bit of discussion of these issues within the larger medical and health care communities, the vast majority of whom have likely never heard of this blog and may have never seen anything other than an occasional news article in local media questioning the leadership of large health care organizations.

Things are Even Worse

Unfortunately, I need to end with the observation that the problems are even worse than what the NEJM article implies. Legal settlements of allegations of bad behavior by large health care organizations are much more numerous than those mentioned in this article (look here for examples).

Many of the largest and most prestigious organizations actually have histories of multiple settlements, guilty pleas, and related legal and governmental findings. For example, look here for Pfizer's record, here for Johnson and Johnson's record, here for Abbott's record, and here for Wellpoint's record. Pfizer was even found by a jury to be a racketeering influenced and corrupt organization (RICO)(see post here).

Despite these records of recidivism, no leaders of these companies have paid any individual penalties, and none of these organizations have had any restructuring or leadership changes imposed. This is even more disturbing when this kid-glove treatment of misbehavior by big health care organizations is contrasted with the severe penalties imposed on individuals or leaders of small companies found guilty of health care fraud (look here).

You Heard It Here First

However, in 2003 we first published documentation of individual physicians' concerns that ill-informed, incompetent, self-interested, or even corrupt leadership was threatening their core values [Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here.] Furthermore, since 2008 we have been stating that corporate fines do not deter bad behavior.

It is not that law enforcement does not have the power to seek penalties on individuals. As we noted here, a Supreme Court case from 1943 empowered the government to seek penalties against responsible corporate officers (the "responsible corporate officer doctrine") who were in a position to stop a fraud that resulted in a guilty plea or conviction, particularly for the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act.  (This was exactly the situation dealt with by the GSK settlement.)  Despite a threat made in 2010 by the chief counsel of the Inspector General's office of the US Department of Health and Human Services to use such legal authority to "get high level executives out of companies," nothing of the sort has happened.

So now that it is no longer taboo to question the pretensions of some leaders of health care organizations to near divine purity, let me state as I did in 2008,

As long as health care leaders can shrug off the consequences of unethical behavior merely as acceptable costs of doing business, absent any serious attempts to get health care organizations to enforce internal codes of ethical behavior or to avoid hiring ethically challenged leaders, the procession will likely continue. The effects will be continually rising costs, declining quality, shrinking access, and rising numbers of demoralized health professionals.

As I wrote in 2009,

Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
  

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….

The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:

How to relate to the patient, evaluate, test and diagnose

How to use solutions, mixtures, methods, supplies and equipment

How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI

How to design and organize your office

How to hire and fire staff and to computerize

How to use public relations and marketing

How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies

Manuals included…

Each attendee receives one set of training materials, including:

Protocol Manual

Physicians Manual

Office Procedure Manual

Forms Book

Marketing Manual

Patient Results Manual

Employee Manual

Audio tapes

and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:

Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director
  

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies
  

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”

Oh yeah: what were the other 2 “avenues”? Those would be:

• Become a Media Personality
• Consult for Wall Street

The Editorial that Wasn't: Evidence for Systematic Research Manipulation Undetectable by Critical Review

Woe to those of us who have been advocates for evidence-based medicine.  A short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values.

Evidence-based medicine is based on some key assumptions.  One is that a systematic review will reveal all the results of research studies that are relevant to the issue at hand.  A second is that while the research studies may be flawed and imperfect, they are reported honestly.

Unfortunately, as we have repeatedly discussed, there is more and more evidence that a systematic review will not reveal all relevant results, because research studies may be suppressed, perhaps often, when their results are unfavorable to vested interests.  (Look here for further discussion.)  There is also considerable anecdotal evidence that the design, implementation, and analysis of research studies may be manipulated to make the results more likely to favor vested interests.  (Look here for further discussion.)

An article by Vedula et al just published in the renowned New England Journal of Medicine suggests that such manipulation might be systemic, and that the reporting of manipulated studies may not clearly show what manipulation was done. (1)

To summarize, the authors got access through legal proceedings to internal study protocols and research reports from clinical trials sponsored by Parke-Davis (later merged into Pfizer Inc) of gabapentin (Neurontin) for a variety of clinical problems other than seizures.  Gabapentin was originally marketed as an anti-seizure drug, but Pfizer later "admitted guilt for off-label marketing."  (We discussed the stealth marketing campaign for Neurontin here.)  Vedula et al compared the primary outcome variables specified in the original research protocols, internal research reports, and any publications of the trials' results.  They identified 21 trials, 13 of which were published.  For 12 of the 13, the authors had access to the internal protocol, report, or both.  The main results were:

For 8 of the 12 published trials, there was a disagreement between the definition of the primary outcome in the protocol and that in the published report.... Sources of disagreement included the introduction of an entirely new primary outcome in the published report (in the case of 6 trials); failure to distinguish between primary and secondary outcomes in the published report, even though the protocol did distinguish between them (2 trials); relegation of a primary outcome in the protocol to a secondary outcome in the published report (2 trials); and failure to include in the published report one or more primary outcomes specified in the protocol (5 trials).

Furthermore, it appeared that failure of published articles to clearly and fully report results in terms of the original, pre-specified primary outcome variables occurred when these comparisons were not favorable to gabapentin. As the authors summarized:

Thus, trials with findings that were not statistically significant (P≥0.05) for the protocol-defined primary outcome, according to the internal documents, either were not published in full or were published with a changed primary outcome.

As shown in Figure 3, all the changes that took place between what was specified in the protocol, what was known before publication (as presented in the internal company research reports), and what was reported to the public led to a more favorable presentation in the medical literature of gabapentin's efficacy for unapproved indications.

They concluded:

We are concerned that the reporting practices observed in our analysis do not meet the ethical standards for clinical research or maintain the integrity of scientific knowledge. Fair and honest treatment of patients enrolled in clinical trials of any kind requires full, open, and unbiased reporting. Journal publication, a formalized platform for scientific discourse and dissemination of knowledge, should not be used as a marketing tool for off-label drug use.

Reporting biases such as those we describe here increase the likelihood that interventions will appear to be effective when they are not. Such biases can lead to the omission of negative findings in systematic reviews of intervention effectiveness and in evidence-based guidelines. For example, the 2005 Cochrane systematic review regarding the effectiveness of gabapentin for acute and chronic pain concluded that it is effective on the basis of published findings and should now be updated with the inclusion of unpublished information made available through litigation.

I believe that the article by Vedula et al is particularly important because it shows what appears to be systematic manipulation of the analysis and reporting of multiple clinical trials of the same drug (but for different indications) that had the effect of making the drug appear efficacious when it likely was not. Furthermore, the manipulation was concealed. The published research articles did not completely describe what the intended primary efficacy outcome variables were, did not provide results in terms of these variables, and instead provided results only in terms of variables that were chosen post-hoc as new primary outcome variables.

To address that latter point, I independently reviewed three of the research publications cited by Vedula et al.(2,3,4) All three were noted to have reported significant results favoring gabapentin in terms of a primary efficacy outcome variable that was not identified as such in the corresponding studies' original research protocols or reports (see the supplementary data provided with the New England Journal article.) Per my review, none of the three published articles offered any hint that what they reported as primary outcome variables were not the variables originally chosen in that capacity, nor did they identify what those original primary outcome variables were, or how comparisons made using them turned out.

The implications of the article by Vedula et al are very important. Hence, I was surprised that the article appeared without an accompanying editorial to discuss these implications, and that its publication did not generate much media interest.

So that gives me an opportunity to comment further.

One could start with the implications for evidence-based medicine. As noted above, a short description of the evidence-based medicine is medicine whose practice is informed by critical, rigorous review of the best available evidence from clinical research as revealed by systematic search of the published research literature, as well as by the clinician's understanding of biology and the medical and biopsychosocial context, and by the patient's own values. Evidence-based medicine depends on critical, rigorous review, but the review process is generally done under the assumptions that research publications honestly describe what was done and what its results were. The review process was never designed to detect dishonest reporting or find information that was deliberately concealed. Manipulation of research (design, analysis, and implementation), concealment of that manipulation, and outright suppression of research threaten the foundations of evidence-based medicine. Yet the article by Vedula et al is part of a growing body of evidence that such manipulation, concealment and suppression are widespread, and done to serve vested interests, often commercial.

That is a huge problem for proponents of evidence-based medicine, but also for physicians who want their practices to be based on science, for patients who want their care to be based on science, and for all those in society who see the advancement of medical science as a way to improve peoples' lives.

As senior author Professor Kay Dickersin noted in an interview with Bloomberg "The trouble is, as a scientist, the publication has always been held up to me as the truth. It's the scientific record. What this study indicated is we can't believe that record."

Furthermore, to be a bit more concrete, most physicians, patients, and policy makers depend on what appears to be honest clinical research to make decisions about individual care and health policy. Deliberate and deceitful manipulation of clinical research to favor sponsors' products has likely lead to excessive use of and payments for drugs and devices that are less effective than advertised, if not useless or dangerous. Thus, it is likely that such manipulation is partially responsible for ever increasing health costs and poor health outcomes.

Finally, we need to start thinking about how we can detect and compensate for manipulation of clinical research in the past, and deter such manipulation in the future. One possible deterrent would be, as was noted by Vedula et al, detailed clinical trials registries that contain complete information about trial protocols.  For this to be effective, there need to be mechanisms to assure compliance, and penalties for non-compliance.  Moreover, since clinical research is now global, the registries must have global scope, and enforced assurance of compliance must also be global.

Registries might decrease future manipulation and suppression of research.   No one has suggested, as far as I know, a systematic way to detect and correct for previous manipulation. It would require a major, global investigative effort to uncover manipulation, and it would be a major scientific and policy endeavor to reveal most suppressed research and correct most manipulations.

However, before anything is done, patients, physicians and policy makers must acknowledge and understand the problem.  Yet it seems that even discussing these may be topics that are very uncomfortable for some of us. The longer we shrink from addressing them, however, the worse will be the results for patients, physicians, science and society.

References


1. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored tirals of gabapentin for off-label use. N Engl J Med 2009; 361: 1963-1971. Link here.


2. Mathew NT, Rapoport A, Saper J et al. Efficacy of gabapentin in migraine prophylaxis. Headache 2001; 41: 119-128. Link here.


3. Vieta E, Goikolea JM, Martinea-Aran A et al. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. J Clin Psychiatr 2006; 67: 473-477.  Link here.


4. Caraceni A, Zecca E, Bonezzi C et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the gabapentin cancer pain study group. J Clin Oncol 2004; 22: 2909-2917. Link here.

No Such RUC - The New England Journal Takes on the Primary Care Crisis, Sort Of

The vast amounts spent globally on health care do not seem to translate into access for many patients, quality care, and improved outcomes. The US, in particular, spends huge amounts, now more than $2 trillion a year, without getting universal access, or superb quality and outcomes. While we spend all this money, the primary care and generalist practitioners on the front lines of care are paid less and less, are increasingly embattled and disgruntled, and their numbers are rapidly thinning.

Although these problems are huge, there is not much clear discussion of them.

Thus, it was encouraging to see the vaunted New England Journal of Medicine, the premier US journal of medicine, take up the issue of the "future of primary care." A few weeks ago, the journal published a series of commentaries on the issue,(1-6) and the transcript of a round table discussion among their authors.(7) It was touted as the views of experts on "the crisis in U.S. primary care."

Unfortunately, although the series acknowledged some surface characteristics of the US health care system that have lead to this crisis, it did not delve further into its causes.

On the surface, a major cause of the crisis is that payments to primary care physicians are so limited that we are driving them out of business, while we pay lavishly for new, high-technology, often risky and invasive procedures.

However, understanding how and why this happens requires dissecting layer after layer of complex details. Doing so can be frustrating, if not eye glazing, and this may be one reason why the discussion of this pivotal issue has been so limited.

The first layer of complexity was implicitly acknowledged, but not discussed in the NEJM series. Bear with me through it.

The First Layer of Causation: Low Payments for Face-to-Face Visits, Rising Overhead

Physicians are paid for each encounter with a patient. Their pay only covers what they do in the presence of the patient, and not other efforts on patients' behalf, e.g., communicating with patients when they are not in the office, communicating with other professionals, paperwork required by insurance companies, etc, etc. Furthermore, pay for office visits is available only in a very small number of categories, and the pay for more complex visits is not commensurate with the increase in time and effort that they require, so that physicians who spend a lot of time trying to deal with complex problems will not be paid commensurate with their work. Pay for office visits has not increased as fast as inflation, and certainly not as fast as the expenses of running physicians' offices, i.e., office overhead, has increased. Thus, to try to maintain income, and to support increasingly complex office operations and overhead, primary care physicians must limit the time they spend with any one patient.

The result is the 15 minute visit for nearly all patients. But it is ridiculous to try to manage complex problems in 15 minute visits. Furthermore, primary care physicians spend hours of unpaid time doing paperwork, communications, etc.

The NEJM special articles dealt briefly with the contrast between how primary care physicians and proceduralists are paid, and the adverse effects of the 15-minute visit. The series coordinator, Dr Thomas Lee, noted that "procedure-oriented specialties offer higher potential incomes."(1) Dr Allan H Goroll decried the "current volume-driven, fee-for-service approaches," the "piecework payment system that perpetuates our 'hamster-wheel' environment."(4) Dr Thomas Bodenheimer asserted that primary care physicians are"overstressed by large patient panels." He blamed this on "the over-burdened 15-minute clinician visit."(3) He mentioned the 15-minute visit three other times in his commentary. In the round table discussion that accompanied the articles, he protested, "it's the tyranny of the 15-minute visit. If you come in to your practice in the morning and you see that you have 12 to 15 15-minute visits in the morning and another 12 to 15 15-minute visits in the afternoon, and you know you can't do it all in 15 minutes...."(7) Finally, in the round table discussion that accompanied the series, Dr Katherine Treadway offered the longest and most impassioned discussion, first explaining the problem,

Since I’ve been in practice a long time and I have an elderly, sick population, that for every hour of face-to-face time, I have another hour, at least, of time that I spend that’s unreimbursed. So, if I’m there for 13 hours, I’m getting paid for about 6 of the hours I’m spending.

and

The RVU system is ...designed for specialty care and single problems. There is nothing in the RVU system that allows you to take into account the fact that you’ve just seen somebody with congestive heart failure, hypertension, hyperlipidemia, coronary disease, renal insufficiency, and diabetes.

Why Are Payments Low for Face-to-Face Visits?

However, none of the commentaries addressed how we got to this pass, or, to continue the analogy above, none dissected the next layer. At best, they seemed to imply that this came about due to the forces of nature or an act of God. For example, in the round table discussion, Dr Lee said,

And I want to go to the payment system next. But do you think — I mean, which comes first, the chicken or the egg? Is it in the water and in the culture, in the educational values? And then the payment system may just reinforce that? Or is it the other way around, the payment system’s where it begins and that’s why it’s in the water?

To which Prof Barabara Starfield could only reply,

Unfortunately, it’s the chicken and the egg cycle. It doesn’t start in any one place.

The Role of the RUC

Actually, one can find the next layer of explanations in one place. The current bizarrely distorted manner in which physicians are paid was the act of people, a few people operating largely in the shadows.

The US Medicare system determines what it pays physicians using the Resource Based Relative Value System (RBRVS). This system determines the pay for every kind of medical encounter according to a complex formula that is supposed to account for physicians' time and effort, physicians' practice expense, and the cost of malpractice insurance. The components of physicians' effort assessed are, in turn, technical skill and physical effort; the required mental effort and judgment; and stress due to the potential risk to the patient.

To keep the system, which was started in 1990, current, requires addition of new kinds of encounters, which means encounters involving new kinds of procedures, and updating of the estimates of various components, including physicians' time and effort. To do so, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee (RUC). The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are secret, as are the proceedings of the group.

This opaque and unaccountable process has resulted in increases outstripping inflation in fees paid for procedures, while fees paid for "cognitive"medicine, i.e., for primary care, and for services that involve diagnosis, management of acute and chronic disease, counseling, coordination of care, etc, but not procedures, have lagged inflation. The effects of the RUC have been amplified by the unexplained tendency of commercial managed care and health insurance to track the RBRVS system when making their own payments to physicians.

For further details about the RUC, see these posts on Health Care Renewal (here, here, here, and here) and important articles by Bodenheimer et al,(8) and Goodson.(9)

The Unanswered Questions

Understanding this layer of the process raises some major questions, whose answers could help dissect the next layers.

• How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
• Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than the RUC?
• How did the RUC become de facto in charge of this process?
• Why does the AMA keep the membership on the RUC secret, and give no input into the RUC process to its general membership?
• Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
• Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?

Of course, since the NEJM series failed to address the role of the RUC in the collapse of primary care, it could not raise, much less begin to answer such questions. The series mentioned the RUC only once, and virtually parenthetically, (by Dr Gorroll, who noted, "the current system "relies on the Relative Value Scale Update Committee [RUC] of the American Medical Association to set values for primary care services, despite the committee's marked overweighting in favor of procedural specialties...."[4]) Despite having written a key article explaining the role of the RUC,(8) Dr Bodenheimer was apparently only asked to write about practice innovations that could somehow compensate for continuing limits on the length of primary care visits.(3) It appears that it remains politically incorrect to question the RUC.

However, failing to understand, or even address the causes of the collapse of primary care will make it all the more difficult to find a way to revive it.

"Those who cannot remember the past are condemned to repeat it." attributed to George Santayana

References

1. Lee TH. The future of primary care: the need for reinvention. N Engl J Med 2008; 359: 2085-2086. Link here.
2. Treadway K. The future of primary care: sustaining relationships. N Engl J Med 2008; 359: 2086, 2088. Link here.
3. Bodenheimer T. The future of primary care: transforming practice. N Engl J Med 2008; 359: 2086, 2089. Link here.
4. Goroll AH. The future of primary care: reforming physician payment. N Engl J Med 2008; 359: 2087, 2090. Link here.
5. Starfield B. The future of primary care: refocusing the system. N Engl J Med 2008; 359: 2087, 2091. Link here.
6. Roland M. The future of primary care: lessons from the U.K. N Engl J Med 2008; 359: 2087, 2092. Link here.
7. Lee TH, Treadway K, Bodenheimer T, Starfield B, Goroll A. The future of primary care: perspective roundtable: redesigning primary care. Link here.
8. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
9. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.

BLOGSCAN - The Anechoic Effect and the HPV Vaccine

MedPundit notes that the New England Journal of Medicine's editorial on the HPV vaccine, which accompanied multiple original articles and commentaries on this topic, omitted any mention of how the manufacturer of the vaccine lobbied state legislatures to make administration of the vaccine mandatory. The anechoic effect lives (in medical journals, but not in blogs).

Two Cases Demonstrating the Reluctance of Medical Journals and Scientific Meetings to Air Criticisms of Vested Interests

Two follow-ups on stories recently discussed on Health Care Renewal demonstrate how hard it is to openly criticize the powers that be in health care in the venues on which most physicians depend for clinical and scientific information.

The American Society of Hypertension Panel on Conflicts of Interest

Last week we had posted about how the American Society of Hypertension had cancelled a scheduled panel discussion at its annual meeting about conflicts of interest and industry influence, after Society leadership decided the panel was too unbalanced. However, although the panel was likely to be critical of industry influence, it would have occurred at a meeting with considerable industry participation.

Now Christopher Rowland reports in the Boston Globe:

The American Society of Hypertension , accused by its critics of stifling debate, has reversed course and says it will host a panel discussion this spring on how pharmaceutical companies influence medical journals and societies.

After the cancellation was reported by the Globe last week, the society's associate executive director, Melissa Levine , said in an e-mail that the society had now decided to add the panel discussion to the agenda for the May meeting in Chicago.

The society is 'committed to conducting a session on conflicts of interest,' Levine said. 'Over the next few weeks we will be working to finalize the session and confirm the speakers.'

But the inclusion of drug industry defenders led one of the original invited panelists, Dr. Marcia Angell , former editor of the New England Journal of Medicine, to question the society's motives, even though she is considering taking part in the session.

'It seems to be standing the whole thing on its head,' said Angell.

She said the original intent of the panel had been to provide a counterweight to the drug industry's sponsorship of scientific papers and physicians at the annual meeting.

The industry advocates added to the panel are Dr. Thomas P. Stossel and William F. Keane.

Stossel, a Harvard Medical School professor and codirector of the hematology division at Brigham and Women's Hospital, said he has tentatively accepted an invitation to participate. He said he looks forward to the chance to defend drug industry involvement in medical societies.

Keane is vice president of clinical development at Merck & Co. Inc. Merck confirmed yesterday that Keane has been invited to present a lecture on 'industry/professional society relationships' but did not say whether he will accept the invitation.

Stossel said yesterday he would use the panel discussion to argue in favor of continued drug company participation and direct financial support of medical societies and doctors.

'There has been 20 years of unopposed air time of this anti-industry, anticommercial criticism,' Stossel said.

As we noted earlier, there is likely to be considerable commercial presence at the ASH meeting. At least 70 commercial exhibitors are expected in the exhibit hall. The Society is offering a variety of opportunities for corporate sponsorship of various meeting activities. Doubtless, many of the research projects to be presented were funded by industry, and many of the presenters are employed part-time by industry as consultants and on speakers' bureaus. Yet the Society seemed worried that a single panel presentation might exclusively present critics of industry, so it had to add an industry representative and an academic who has been an uncritical defender of industry to it. There may be some criticism of some practices by the pharmaceutical, biotechnology, and device industries in the media, but this case demonstrates how hard it is to criticize industry in more professional health care circles.

The "Defanged" New England Journal of Medicine Article on Epoetin

Last week, we posted about how the New England Journal of Medicine spiked a commentary by Dr Robert Steinbrook, one of its "national correspondents," that included discussion of commercial involvement in the National Kidney Foundation guidelines that promoted aggressive use of epoetin in anemic patients with renal failure. Instead, the Journal published a commentary by an author who has ties to the National Kidney Foundation, and which did not discuss or criticize the Foundation's commercial support. Steinbrook's commentary was eventually published in Lancet. [Steinbrook R. Haemoglobin concentrations in chronic kidney disease. Lancet 2006; 368: 2191-2193.]

This week the New England Journal of Medicine published another commentary by Dr Steinbrook entitled "Medicare and Erythropoietin." [Steinbrook R. Medicare and erythropoietin. N Engl J Med 2007; 356: 4-5. ] This version omitted any discussion, much less criticism, of industry involvement in these guidelines. Conspicuously absent was this passage found in Steinbrook's Lancet commentary:

Over the past decade, National Kidney Foundation guidelines have improved the clinical care of patients with chronic kidney disease in many areas, including vascular access and the adequacy of dialysis. They have, however, been questioned for their reliance on expert opinion and because of the close relations between the Foundation, the Kidney Disease Outcomes Quality Initiative (KDOQI) that formulates its recommendations, and the drug industry. In fiscal year 2005, according to its annual report, the Foundation received $19·7 million—57% of its total support—from various 'corporate and organizational partners'. In calendar year 2005, it received $4·1 million from Amgen and $3·6 million from Ortho Biotech, a subsidiary of Johnson & Johnson, the current marketers of epoetin products in the USA. Amgen supported the development of the anaemia guidelines and is acknowledged as 'the founding and principal sponsor of KDOQI.' 11 Of the 18 members of the workgroup, two-thirds disclosed financial associations with Amgen or other epoetin manufacturers or marketers. In an October, 2006, fact sheet, the Foundation responded to 'some controversy [that] has arisen due to the fact that KDOQI guidelines have been supported by industry. The NKF continually reviews its policies and procedures to safeguard the work product of KDOQI and to ensure that no sponsorship funds contributed to the NKF ever influence the content of any of the KDOQI guidelines.'

Steinbrook recommended,

Physicians and dialysis facilities need updated guidance about the management of anaemia and what is best for patients. Given the billions of dollars at stake for the drug and dialysis industries, such guidance is likely to receive the broadest acceptance if developed without industry support, and by experts without relevant financial associations. This might be accomplished under the auspices of the National Institutes of Health Consensus Development Program or the Agency for Healthcare Research and Quality.

Such a recommendation also did not appear in the New England Journal of Medicine article.

So it also seems that the New England Journal of Medicine could not bear to publish any discussion or criticism of commercial involvement in this particular instance of guideline development.

[Hat tip: GoozNews. As Merrill Goozner said, the Steinbrook article may have been "unspiked," but it surely was "defanged" in the process.]

Summary

Many physicians learn about clinical medicine, clinical science, and health policy from prominent journals and by attending prestigious scientific meetings. Yet these journals and meeting often are supported by commercial firms and other organizations with vested interests. These well-reputed fora, often regarded as objective, seem singularly reluctant to allow discussion of the role of commercial funding and influence in their proceedings. So not only are physicians who depend on these traditional sources of information likely to be exposed to information that is influenced by those with vested interests, they are unlikely to be exposed to any criticism of the biases that may thus arise.

Of course, in this age of the internet, there are other ways they may yet be exposed to such criticism. The longer the traditional journals and meetings try to pretend such criticism does not exist, the less trust they will inspire.

"Medical Journal Spikes Article On Industry Ties"

From the Wall Street Journal, an article that will pretty much speak for itself, with a little re-ordering and editing by yours truly. First, there was the spiked commentary,

The New England Journal of Medicine last month published studies warning that aggressive efforts to treat anemia in kidney-disease patients with the drug erythropoietin, or EPO, as recommended by the National Kidney Foundation, appear to increase the risk of heart failure and the need for dialysis. [See related posts here and here.] But the medical journal spiked an opinion piece commissioned from one of its senior writers that was critical of the foundation's reliance on multimillion-dollar donations from the companies that make such drugs.
Meanwhile, the author of the spiked editorial, Dr. Robert Steinbrook, submitted it to one of the journal's chief rivals, the British medical journal Lancet, which ran a version on its Web site on Nov. 17, a day after the New England Journal published its reports on the matter. [Steinbrook R. Haemoglobin concentrations in chronic kidney disease. Lancet 2006; 368: 2191-3.]

Dr. Steinbrook's article said that the foundation's guidelines have been questioned because of the group's close relationship with the drug industry. The article also noted that in fiscal 2005, the foundation received more than half of its support from 'corporate and organizational partners,' and, in the calendar-year 2005, it received $4.1 million from Amgen Inc. and $3.6 million from Johnson and Johnson's Ortho Biotech, the current marketers of EPO in the U.S.

The kidney foundation, which issued its recommendations earlier this year, credits Amgen as the 'founding and principal sponsor' of the guidelines. Such sponsorship is unusual -- the American Diabetes Association, for instance, says it doesn't 'receive or allow for any corporate contributions for our clinical practice recommendations.'

Ellie Schlam, a foundation spokeswoman, says Amgen's sponsorship money paid for guideline-development staffers, a $3,000 grant to each member for travel to meetings and other expenses, plus phone, faxing, copying and other administrative expenses. A disclosure on the foundation's Web site noted that most members of the guideline group have a financial relationship with either Amgen or dialysis providers, who resell EPO and stand to profit from its increased use. Still, the foundation says sponsors aren't informed or involved in any aspect of guideline development.

A spokesman for Amgen said the company is 'not involved in the creation and design of the guidelines we sponsor.'

The New England Journal declined to discuss Dr. Steinbrook's article, saying 'we discuss only content that we have published.' Dr. Steinbrook, a former deputy editor of the New England Journal, has been a national correspondent since 2002. According to a person familiar with the matter, he was told his manuscript lacked balance because it suggested that the commercial support of the guidelines influenced the medical recommendations made by that group. New England Journal editors also criticized the piece for failing to credit the guideline writers for striving to find the right balance when it comes to anemia guidelines.
Meanwhile, Richard Horton, editor of the Lancet, said 'I was surprised Robert came to us because I have admired his work for the New England Journal of Medicine.' Dr. Horton said of the article: 'We thought it extremely important -- because of the significant clinical implications and because of the questions it raised about the propriety of the arrangements over funding and guideline development.'

Then there was the more innocuous in-house editorial,

The journal did run a less-critical editorial on the studies co-authored by Julie Ingelfinger, a nephrologist and deputy editor at the journal who is the immediate past president of the Massachusetts-based chapter of the National Kidney Foundation and a member of the state group's medical advisory board. The editorial that ran made no mention of the foundation's industry funding, and Dr. Ingelfinger's relationship with the foundation wasn't disclosed.
Asked why Dr. Ingelfinger's roles at the Massachusetts Kidney Foundation weren't listed along with the article she co-authored, a spokeswoman for the New England Journal said, 'We publish financial associations that are relevant to the content of the article. We tend to be inclusive, rather than exclusive.'

Frank Davidoff, the editor emeritus of the Annals of Internal Medicine, says Dr. Ingelfinger's association with the kidney foundation should have been made known to readers. 'She should have disclosed that, even if she is the best person to write the editorial,' he said. Dr. Davidoff said medical journals historically have paid less attention to the potential conflicts of editorial writers than they have to researchers publishing original studies.

And the somewhat under-stated conclusion,

The handling of the two articles has reignited debate about the journal's standards and whether it is tough enough on issues involving industry funding of research and treatment guidelines.

Again, as we have stated before, people with conflicts of interest may not be consciously aware of the binds in which they find themselves. However, common sense, economics, and cognitive psychhology suggest people respond to incentives, including financial incentives (see post here). If a person or organization is paid by company x, how likely is he, she, or it to criticize company x's products? How likely is he, she, or it to give company x the benefit of the doubt?

Thus, at a minimum, we urge that all potential conflicts of interest affecting health care decision makers, and those who seek to influence them, ought to be fully and thoroughly disclosed. And we need to consider whether some such conflicts ought to be banned outright.

But people with conflicts, who are now prevalent in academic medicine, and various other health care organizations, are likely to find such discussions very uncomfortable. But that is just why we need to have them.

A Former Editor Cites Foucault

A while back, we posted about the firing of the editors of the Canadian Medical Association Journal (CMAJ), noting this seemingly unfortunate example of a power struggle within a medical organization. However, the firing of Dr Hoey has generally been presented in terms of abuse of power as a violation of editorial independence.

For example, in 2005, Hoey wrote an unsigned editorial in CMAJ that started with the premise, "freedom from interference in editorial decisions stands at the heart of the credibility of any reputable journal." He then announced "we have a transgression to report," and then went on to recount how "a CMA [Canadian Medical Association] executive objected strenuously to a news article we were preparing on behind-the-counter access to levonorgestrel (Plan B)."(1) Similarly, the editor of the British Medical Journal responded to Hoey's firing, "this is a sorry tale that shows how little the CMA (its officers and - since there is no sign of a concerted outcry from them - its members) understands what it means to be the custodian of an international academic medical journal."(2)

There has been much more discussion of the firing of Hoey and then the departure of many other CMAJ editors. The New England Journal of Medicine ran a commentary in March.(3) Last week, it ran another, this time written by Dr Hoey, himself.(4) Would this more clearly delineate what happened?

Hoey's article, however, took an unusual stance. He chided "owners [who] may wish to limit to limit the scope of their journal, to restrict its editorial perspective to matters of bedside medicine and the narrower interests (as perceived by the usually nonphysician publishers) of their physician readership." He then denied this "vision." Instead, he proclaimed, "for Foucault, medicine is a political act."

That is where he lost me, decisively. The Foucault he cited, assuredly is Michel Foucault, one of the "postmodern vanguard," authorities repeatedly cited to justify the fashionable post-modern concepts that have swept through the academic humanities and social sciences. Foucault is cited:

• For his hostility to the Enlightenment. For example, he wrote, "it is meaningless to speak in the name of -or against - Reason, Truth, or Knowledge."(5) Hicks explained, "Postmodernism rejects the entire Enlightenment project. It holds that the modernist premises of the Enlightenment were untenable from the beginning and that their cultural manifestations have now reached their nadir. While the modern world continues to speak of reason, freedom, and progress, its pathologies tell another story. The postmodern critique of these pathologies is offered as the death knell of modernism: 'The deepest strata of Western culture' have been exposed, Foucault argues, and are 'once more stirring under our feet.'"(6)
• To support the self-contradictory and ultimately meaningless assertion that there is no external reality, that reality is "socially constructed." "Foucault at times suggested that underlying what counts as objective knowledge is a power relation, one category of people benefiting at the expense of another category of people. The radicals thus see the social construction of reality...."(7)
• To support totalitarianism. "As part of the attack on the Enlightenment, the critique of truth suffers from a tendency to reinforce pre-enlightenment despotism. The Enlightenment replaced individual and institutional power with more objective measures of validity, and it is no surprise that the rejection of objectivity collapses back into power as a means for defining absolute truth."(8) Foucault's belief that "liberal democracies are actually more oppressive than medieval despots or even modern totalitarians,"(9) was consistent with his occasional embrace of totalitarian rulers. In 1971, he said, "when the proletariat takes power, it may be quite possible that the proletariat will exert toward the classes over which it has triumphed a violent, dictatorial, and even bloody power. I can't see what objection could possibly be made to this."(10) Similarly, he extolled the 1978 Iranian revolution, "exulting in the 'intoxication' of revolution and the violent expression of 'collective will,' and praised its leaders 'political spirituality,' which he thought reflected a health 'religion of combat and sacrifice.'"(11)

In my humble opinion, citing Foucault as an authority suggests a sympathy for post-modernism that would not be helpful to a journal editor. Most of editing is about science, and science does not fit with the notion that external reality does not exist. Readers of Health Care Renewal are certainly aware that medicine and health care are influenced by politics. But the notion that politics is all of medicine, or a totalitarian world view will not help us address concentration and abuse of power.
But perhaps Hoey's citation of Foucault was a mistake, or misinterpretation. After citing Foucault, Hoey admonished journal editors not to discuss or even divulge editorial decisions to their publishers, for that would "gut the editorial independence of a journal." However, the editor's outlook and assurance should include "an eager propensity to poke a stick into something or somebody." That proclamation suggests that Hoey's reliance on Foucault was not some mistake. Characterizing an ideal journal editor as an undisciplined trouble-maker fits Foucault's fascination with "limit experiences."(12) Yet editors whose main joy is in poking sticks into something or somebody without restraint or accountability will only add to concentration and abuse of power.
Thus, it still seems like our original characterization of the dispute at CMAJ was apt, "A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar." That's too bad.
References
1. CMAJ. The editorial autonomy of CMAJ. Can Med Assoc J 2006; 174: 9.
2. Godlee F. A big mistake. Brit Med J 2006; 332:
3. Shuchman M, Redelmeier DA. Politics and independence - the collapse of the Canadian Medical Association Journal. N Engl J Med 2006; 354:1337-1339.
4. Hoey J. Editorial independence and the Canadian Medical Association Journal. N Engl J Med 2006; 354: 1982-3.
5. Hicks SR. Explaining Postmodernism: Skepticism and Socialism from Rousseau to Foucault. Tempe: Scholargy Publishing, 2004. P. 2. (Link here)
6. Hicks, P. 14.
7. Farber DA, Sherry S. Beyond All Reason: the Radical Assault on Truth in American Law. New York: Oxford University Press, 1977. P. 24. (Link here)
8. Farber, Sherry. P. 106.
9. Farber, Sherry, P. 29
10. Lilla M. The Reckless Mind: Intellectuals in Politics. New York: New York Review of Books, 2001. P. 150. (Link here.)
11. Lilla. P. 154.
12. Lilla. P. 150.