The CareFusion/ Denham/ NQF Case - the Plot Thickens

The story about CareFusion, its financial relationships with Dr Charles Denham, and his alleged role in promoting a CareFusion product through standards produced by the National Quality Forum has gotten even more complicated.  This means that the tasks faced  by National Quality Forum leaders who asserted their intent to improve their conflicts of interest policy in response to this case just got more complex.

Background

As we most recently discussed here, the basics of the case were:
-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
 -  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
-  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.

I opined that the NQF response to this case was more open and pro-active than responses by many other organizations to cases involving conflicts of interest, although there was still room for the NQF to further strengthen its conflict of interest policies.

The Plot Thickens

Since last week, three more articles on the case have appeared, in Modern Healthcare, the WBUR CommonHealth blog, and on ProPublica.  These pointed out additional disturbing aspects of the case.

Dr Denham's and CareFusion's Relationships with the NQF Were Even More Complex than Heretofore Revealed

According to ProPublica,

in response to questions from ProPublica, the Quality Forum divulged that Denham’s nonprofit was one of its contributors, and that in 2007 and 2008 it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009.

Also,

Between 2006 and 2009, Denham’s nonprofit donated $725,000 to the Quality Forum. The group and Denham had a five-year contract, but the Quality Forum declined to provide a copy or explain the terms, saying only that it was ended three years early, in 2010, after concerns about Denham emerged. 

Not only did the non-profit help fund the NQF, it was directly involved in relevant NQF activities,

According to [Dr Denham's attorney Lawrence] Gondelman, Denham’s nonprofit was obligated to provide financial and staff support for Quality Forum projects, including evidence-based medicine reviews, hosting webinars and creating multimedia presentations about the safe practice recommendations.

 Furthermore, while the NQF asks committee members to disclose conflicts of interest verbally at the start of each meeting, again according to ProPublica,

Both [Dr Patrick] Romano and Dr. Peter Pronovost, who leads a patient safety institute at Johns Hopkins Medicine, said they had been unaware of Denham’s financial ties with CareFusion. Quality Forum officials said Denham never reported them, nor did he mention them during the 2009 meeting when members were asked to disclose their financial relationships, the transcript shows.

'He clearly lied,' Dr. Christine Cassel, the Quality Forum’s president and CEO told ProPublica. 'He just didn’t say anything about any of his business relationships.'

The Clinical Evidence in Support of the CareFusion Product Denham Touted was Dubious

According to ProPublica's review of a transcript of the meeting about the NQF standards that Denham co-chaired,

At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic.

CareFusion's ChloraPrep is apparently the only well known 2 percent chlorhexidine antiseptic.

However, the same article pointed out that the study too was affected by conflicts of interest. Its authors "all reported ties to Cardinal Health,' the company from which CareFusion was spun off.  Furthermore, ProPublica charged that Dr Denhams company was involved with the financing of that study.

Also, per an interview with Brian Johnson, publisher of MassDevice.com, WBUR reported:

the government says there are several ways this study did not use accepted protocols. For example, a member of the company’s sales and marketing staff reviewed the data from the clinical trial and edited the final study. Prosecutors also say the company failed to 'review, evaluate and report safety information' and failed to obtain and maintain accurate records showing all financial transactions from CareFusion to Dr. Rabih Darouiche, the lead investigator on the study.

Thus, it appears that this study may have been manipulated (in particular, by a company marketer's editing) to make its sponsor's product look more favorable (in this case, particularly by ignoring data about safety and adverse effects)

 NQF Went Farther to Endorse CareFusion's ChloraPrep than Was Heretofore Appreciated

 According to the WBUR interview,

The NQF didn’t adopt a recommendation of Chloraprep but Denham hosted webinars with Dairouche under the NQF brand for hospital staffers that absolutely endorsed Chloraprep. So while it didn’t end up in the official financial recommendations, there certainly was influence. 

However, according to ProPublica things were even more complicated.  Denham promoted ChloraPrep in not one, but two instances,

At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic.

[Dr Peter] Pronovost said it wasn’t necessary to actually identify ChloraPrep because it was well known as the product with the 2 percent chlorhexidine formulation.

The committee members agreed that chlorhexidine was an effective antiseptic – guidelines by the Centers for Disease Control and Prevention (CDC) say so as well. But studies show it also works in other concentrations and combinations.
Discussion turned to recommendations for preventing infections caused by central lines, the thin tubes inserted into a vein to deliver fluids or medications. Dr. Gregg Meyer of Massachusetts General Hospital in Boston, the co-chair of the committee with Denham, brought up the forthcoming study.

'Chuck (Denham) made me aware of it,' Meyer said. He then asked Pronovost, a leading expert on preventing central-line infections, what he thought

The final report did delete the specific reference to ChloraPrep as the preferred method for preparing surgical sites,

.After the meeting, when the committee’s draft report was published in late 2009, a recommendation for preparing surgical sites to prevent infection did not name ChloraPrep but did specify its telltale formula – a 2 percent chlorhexadine and alcohol antiseptic.

That draft recommendation was challenged by 3M, a company that makes a competing product. A scientific review of the evidence by a Quality Forum ad hoc committee found a lack of clear evidence to support one skin prep product over another. As a result, the recommendation to use the ChloraPrep formulation on surgical sites didn’t make it into the final 2010 safe practices report. 

However, the final report did appear to endorse ChloraPrep for reduction of central line infections,

 On the separate issue of reducing central-line infections, the 2009 draft report endorsed a chlorhexidine antiseptic but did not specify any one concentration – just as the committee decided. Yet the final 2010 report does call for a 2 percent chlorhexidine and alcohol antiseptic like ChloraPrep. 

Also, again per ProPublica, the NQF seemed to have been roped into other efforts run by Dr Denham to promote ChloraPrep,

Although Quality Forum officials seemed surprised to learn this last week from ProPublica, the group is listed as a co-host, with Denham’s nonprofit, of a webinar where the 2010 safe practices guidelines for central-line and surgical site infections are presented.

The presentation, posted on the website of Denham’s nonprofit, states that the Quality Forum recommends the ChloraPrep formulation to protect against both central-line and surgical site infections.    

CareFusion also cites the Quality Forum’s endorsement in at least one brochure on its website.

Summary: a Longer Row to Hoe

It looks like NQF will have to deal with even more specifics if it wants to prevent future compromises of its standards due to conflicts of interest and manipulation of the clinical research evidence base.

It will have to consider:
-  Whether individual disclosures of conflicts of interest can be trusted
-  Whether it is prepared to deal with the apparently nearly infinite variety of conflicts that creative minds can produce to promote vested interersts
-  How to be appropriately skeptical of clinical evidence used to devise standards when such evidence is now so susceptible to manipulation and/or suppression to further vested interests
-  How to better recognize the various kinds of machinations that the conflicted may endeavor to promote their interests

Again, my question is whether it may just be better to ban individuals with conflicts of interest from roles in which they may influence standards in favor of vested interests, rather than continuing to try to "manage" the complex web of conflicts and the actions they may produce generated by an increasingly commercialized and simultaneously poorly regulated health care system.

By the way, if anyone in other organizations is sitting back thinking this is just an NQF problem, they ought to think again.  As we have discussed, the web of conflicts of interest, both individual and institutional, is vast, and the extent of manipulation and suppression of the clinical research base is equally vast.  Every health care decision maker, health policy decision maker, and health care organization is confronted by similar problems which may differ only in the details.

Again, I applaud the NQF for trying to deal with these issues upfront, and hope that others will learn from the lessons this case provides.

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss..

Background


As we noted yesterday, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the latest appearing today.

In summary prior to the latest article,
-  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision

We noted that the NQF policy on conflicts of interest for its standard writing committees seemed somewhat weak.  The current (October, 2013) policy asks members to internally disclose conflicts and recuse themselves from " discussion of the applicable measure or measures, and in some instances competing and related measures."  However it does not ban members with conflicts, nor require public disclosure of conflicts.  We also noted that NQF has several board members who have full-time leadership positions with health care corporations, financial firms that invest in health care, or health care trade associations, and NQF received funding from pharmaceutical companies and their in-house foundations.  Thus NQF appears to have its own institutional conflicts of interest. 

So we thought that the case raised questions about how well NQF standards are protected from the influence of conflicts of interest, and whether they should remain so influential in the absence of stronger protections?

NQF Clarifies its Conflicts of Interest Policies

As reported by Modern Healthcare, it took only a day for the NQF to issue yet another press release to clarify its conflict of interest polcies.  In particular,

I n response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010:

• Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;
• Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;
• Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;
• Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and
• Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;

So NQF appeared to react ad hoc to concerns that Dr Denham was too avid about the use of a particular product.  Its response included strengthening its COI policy and banning one particular type of conflict, receiving funding from an organization controlled by a member of a standard writing committee.  However, as we noted above, the 2013 policy still has its weaknesses.  

Furthermore, an NQF executive volunteered to inform me that while the current written COI policy does not require public disclosure, in practice the organization requires public verbal disclosure of conflicts at the beginning of each committee meeting, and that the transcripts of these disclosures are available on the organization's website.  However, how to reach these disclosures is not obvious, and I so far have not been able to find the transcript that supposedly contains the disclosures for the meeting which Dr Denham co-chaired


Summary and a Few Optimistic Thoughts (Rare as They are for Us)

What I must say is now most unusual in the CareFusion/ Dr Denham/ NQF case is that NQF leadership, rather than  hunkering down in a defensive posture we have seen many other leaders adapt, seems to be trying to take steps toward addressing problems posed by conflicts of interest affecting its standard setting, guideline development, and quality assurance.  First, it is clear that NQF leaders did react to concerns about Dr Denham, and did somewhat tighten up their conflict of interest policies in response to them.  Second, it is clear that they are willing to listen to public questions and criticism, and at least consider further change in response to them.  They thus appear far more open than do leaders of many other organizations.

IMHO, NQF leadership is to be congratulated for this more transparent approach.  If only the leaders of other health care organizations would do as much. 

Since they do seem open to criticism and change, in the spirit of constructive criticism, I do hope that NQF leaders might also consider:
-  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
-  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching
-  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives

Health care leaders who see transparency and reduction of conflicts of interest as important goals show us that true health care reform might actually be possible.

ADDENDUM (24 January, 2014 - I was told that many people may need an explanation of the title.  "Putting in the ski lifts" is a shortened version of an old college saying.  The location for the ski lifts was a place that is traditionally very hot, think fire and brimstone.  The phrase refers to an extremely improbably event.  Sorry about any confusion.   

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared.

The Basic Story: Off-Label Marketing 

The story was initially briefly reported in the media.  A report in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete,

CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep.

Under the terms of the settlement with Washington, other states, and the federal government, CareFusion will pay a total of $40.1 million.

In particular,
 

When the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer can’t market or promote it for an 'off-label' use – any use not approved by the FDA.

Chloraprep was approved for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or an injection. The FDA rejected its use for prepping the skin prior to inserting catheters into veins for administering medications, or cleaning the skin as part of closing wounds.

The lawsuit alleges that from Sept. 1, 2009 to Aug. 31, 2011, CareFusion promoted Chloraprep for improper uses. CareFusion also allegedly publicized unverified information about Chloraprep during the same time period, Ferguson said.

So this follows a template we have seen before, most recently here.  A company promotes a drug or device for "off-label" uses.  While physicians are legally allowed to prescribe a drug or use a device for reasons other than its official indications, companies are not legally allowed to promote such uses.  Sometimes it turns out that the drug has benefits that outweigh its harms when used off-label, in which case the violation could be considered technical.  In other cases, the drug might turn out to be useless or even net harmful when used off-label, so the violation indicates putting revenue ahead of patients' welfare.  

The reporting on the CareFusion Chloraprep settlement did not clearly suggest that the off-label use was harmful to patients.

Allegations of Kickbacks to Promote Off-Label Use, but How?

It gets more interesting.  The Post-Intelligencer also noted,

The states also contend that in 2008 CareFusion’s predecessor corporation entered into agreements that CareFusion assumed legal and financial responsibility for. This included payments to Health Care Concepts Inc., payments that were allegedly made to hide kickbacks to the physician-owner of HCC for promoting and influencing providers to use Chloraprep, he said. This violates federal and state anti-kickback laws.

Now the allegations also include kickbacks to the "physician-owner" of a company to facilitate off-label promotion.  So the issue goes beyond a technical violation of the law.  The Post-Intelligence report, however, did not make clear what Health Care Concepts Inc actually did to contribute to off-label promotion.

A quick attempt to find out more about this company via the web was not fruitful.  There are lots of companies/ organizations called Health Care Concepts or some variant.  The most relevant may be this one, which lists CareFusion as a "partner" on its main web-page.  What this company actually does is a bit unclear.  Its business model is described as "a private incubator of early products, services, and technologies, as well as an accelerator of mature solutions that will be taken to scale." What that has to do with off-label promotion of a product of a big established company like CareFusion is not clear.  How this company could have influenced providers is not clear, given that it is not an advertising firm, public relations firm, or medical education and communication company (MECC).

So what is going on here?  

Allegations of a $11.6 Million Payment to Manipulate the National Quality Forum Standards


Yesterday, 21 January, 2014, Modern Healthcare began to explain the mystery.   

Many healthcare companies have been accused of paying kickbacks to influence physicians' medical decisions, but one major supplier allegedly tried to steer an entire industry by influencing the recommendations of the National Quality Forum

The NQF, which reviews medical evidence and makes recommendations for improving healthcare, acknowledges that a well-known patient safety advocate is alleged to have received millions of dollars to promote a surgical sterilization product while co-chairing an NQF committee that suggested hospitals use that product. 

Federal officials say Dr. Charles Denham, co-chair of NQF's Safe Practices Committee in 2010, received $11.6 million from San Diego-based CareFusion to promote the company's ChloraPrep line of skin-preparation products. Denham's committee at the NQF also recommended surgeons use ChloraPrep products to prevent surgical infections, the NQF said.

The allegations about the role of Dr Denham in the NQF also did appear in the the official US Department of Justice press release.

Allegations of Bogus Contracts, and Non-Denial Denials

The allegations produced some non-denial denials (in the phrase found in All the President's Men).

Dr Denham responded, but through a lawyer:

A statement from Denham's attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, said reports that the underlying lawsuit involved Dr. Denham were 'blatantly false.'

Denham was not accused of wrong-doing in the whistleblower lawsuit, and Gondelman said Denham has and continues to cooperate with investigators in the case.

Note that while the attorney denied that Dr Denham was named in the underlying lawsuit, he did not apparently specifically deny the allegations.

The NQF also reponded,

 An NQF review committee removed the reference to the specific product before final publication of 'Safe Practices for Better Healthcare' in 2010.

'An NQF ad hoc review did not find sufficient evidence to support one skin preparation over another,' a statement from the organization said. 'The ad hoc review effectively served its role of rapidly responding when a potential issue is identified.'

Note that the NQF press release did not deny that the CareFusion money was given to Dr Denham's organization, nor that the NQF report might have promoted the use of a class of products in which CareFusion's Chloraprep resides.

A follow-up story in Modern Healthcare noted that Dr Denham confirmed the payment of the money to his company, but not its purpose,

 Renowned quality expert Dr. Charles Denham confirms that CareFusion paid his company more than $11 million, but Denham says he was surprised to see the U.S. Justice Department describe the money as kickbacks intended to influence national quality-of-care guidelines published by the National Quality Forum.

Dr Denham's lawyer confirmed the payment, but did not further explain it:

Denham's lawyer, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, acknowledged that CareFusion did pay Denham's company under two contracts. 

And,

Gondelman said the $11.6 million paid to Denham's company covered 'an array of services' and that he could not elaborate.

Again, note that Mr Gondelman did not specifically deny that the money served as a kickback.

Meanwhile, the Department of Justice alleged something more elaborate, and nefarious, 

The Justice Department, though, says the contracts were written to look as though CareFusion was buying consulting, software development and strategic marketing services, as well as the completion of three unnamed projects. The value of the deals, the government alleges, far exceeded the fair-market costs of those services, and that one of the actual purposes of the deals was to conceal kickbacks to Denham while he served on the National Quality Forum.

Interval Summary

So what is clear so far is that:
-  CareFusion agreed to a $40.1 million settlement of allegations that it provided kickbacks to promote off-label use of its product.
-  CareFusion paid $11.6 million to Health Care Concepts
-  Health Care Concepts is run (and possibly owned) by Dr Charles Denham, who chaired a National Quality Forum committee that recommended use of CareFusion's product ChloraPrep in a performance standard and the final version of the NQF standard recommended use of a group of products including ChloraPrep

We have frequently discussed how health care corporations may promote goods, particularly drugs and devices and services through deceptive and unethical practices, including inducements ranging form creation of conflicts of interest to outright bribes and kickbacks.   We have also discussed the influence of individual and institutional conflicts of interest on clinical practice guidelines.  This has become an important enough problem for the US Institute of Medicine to weigh in with standards for trustworthy guidelines that markedly limit such conflicts of interest. 

This case seems notable because it may link the problems of deceptive and unethical promotion with the influencing of clinical practice guidelines.  It is particularly notable because the organization generating the guidelines in question, the National Quality Forum, has become large, influential, and authoritative.  Re the latter point, the latest Modern Healthcare article affirmed,

The NQF is a standards-setting organization for the healthcare provider industry. It holds the exclusive contract to provide Medicare and Medicaid with recommendations on a national quality-of-care strategy and the measures used to gauge improvements.

In fact, while the NQF performance standards can function as guidelines, they also may be bases for pay for performance schemes that attach real incentives to guidelines, which could become perverse if the guidelines have been manipulated.

Can the NQF Defend Against Conflicts, and If Not, Should it Remain So Authoritative?

So the big question is whether the NQF, given its unique influence, has any meaningful approach to prevent its standards from being influenced by conflicts of interest?

The NQF does have a recent conflicts of interest policy. However, according to my reading, it neither bans committee members with conflicts of interest, nor even requires public disclosure of conflicts of interest.  All it seems to require is that committee members disclose conflicts internally and voluntarily recuse themselves from deliberations which may be affected by them.  Although the policy states that conflicts of interest may be made public, I could find nothing in the report which Dr Denham co-authored about conflicts of interest or competing interests affecting any of the authors, including Dr Denham

Furthermore, a very quick look at information publicly available on the NQF web-site suggests the organization itself may have major institutional conflicts of interest.  The NQF is one of those "public-private partnerships" that have become all the rage.  Several members of its board of directors have leadership positions in large health corporations, financial firms with large health care interests, or trade associations for large health care corporations: 

- Elizabeth J. Fowler, PhD, JD, is Vice President, Global Health Policy, in the Government Affairs & Policy group at Johnson & Johnson.

- Robert Galvin, MD, is Chief Executive Officer, Equity Healthcare, at The Blackstone Group.

 - Karen Ignagni, President and Chief Executive Officer of America’s Health Insurance Plans (AHIP), is the voice of health insurance plans....

- J Mark Overhage MD, PhD,  Chief Medical Informatics Officer, Health Services, Siemens Healthcare


Thus it is conceivable that they could personally profit, and that their organizations could institutionally profit from standards that favor their organizations' interests.  

Furthermore, NQF receives funding from the US government and private foundations, but also from pharmaceutical companies and their in-house foundations:

the Bristol-Myers Squibb Foundation, the Cardinal Health Foundation, Pfizer Inc., Sanofi-aventis,...

Unless the current case leads to big changes in the prevalence of conflicts of interest among the NQF board, the continuation of its institutional conflicts of interest generated by its sources of funding, and its weak policy on conflicts affecting committee members, the question becomes whether it should continue to have such an authoritative role?

As we have said over and over, pervasive conflicts of interest affect health care decision-makers and policy makers and the organizations within which they function.  Such conflicts threaten to put various private interests way ahead of patients' and the public's health.  If we really want health care that will put patients' and the public's health first, we need to end such arrangements that favor private gain.  

 Roy M. Poses MD on Health Care Renewal

ADDENDUM (23 January, 2014) - A closer re-reading of the NQF conflict of interest policy made it clear that recusal is not voluntary, and that conflicts of interest may be revealed publicly, but that such disclosure is not mandatory.  The paragraph above dealing with these issues was revised accordingly.  

A Call to Restore the Integrity of Clinical Research - but Will Anyone Heed it?

Concerns about suppression and manipulation of clinical research to serve vested interests have finally gotten a little more mainstream.

Background: Suppression and Manipulation of Clinical Research

For a long time, we have decried and discussed examples of manipulation of clinical research done to increase the likelihood that its results would please vested interests, often drug, device or other corporations that sponsored the research and often exerted considerable control over its design, implementation, analysis, and dissemination.  We have also decried and discussed examples of suppression of research whose results offended such vested interest, sometimes done when manipulation did not succeed in producing such pleasing results.


I wrote about suppression of research in my 2003 paper on health care dysfunction,(1)

The integrity of medical research has been violated by the deliberate suppression of its results.

That assertion was based on several important, although understandably largely anechoic cases.

I first wrote about systematic attempts to manipulate clinical research in 2005, based on Richard Smith's PLoS Medicine commentary which listed specific tactics that vested interests could use to make it more likely that research studies would provide them with favorable results.

Although striking cases of manipulation and suppression appeared more frequently starting in the 1990s, in the last few years it has become more apparent that these are widespread problems.

A Call to Restore Integrity

This week, the British Medical Journal published a special article calling for restoration of suppressed or manipulated clinical trials(2), accompanied by an editorial entitled, "restoring the integrity of the clinical trial evidence base."(3)

The article used slightly different terminology than we do, replacing suppression with invisibility, and manipulation with distortion, thus,

Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. The first is no representation (invisibility), which occurs when a trial remains unpublished years after completion. The second is distorted representation (distortion), which occurs when publications in medical journals present a biased or misleading description of the design, conduct, or results of a trial.

The article boldly asserted

Both go against the fundamental scientific and ethical responsibility that all research on humans be used to advance knowledge and are symptomatic of a general culture of data secrecy. The end result is that the healthcare, biomedical research, and policy communities may, despite best intentions and best practices, end up drawing scientifically invalid conclusions based on only those parts of the evidence base they can see.

The editorial went further, asserting that

This crisis of hidden or misreported information from clinical trials—and the resulting distortion of the clinical evidence base—is widely recognized and commonly decried. It is one of the leading scientific problems of our time, but few solutions have been put forward.

Furthermore, it concluded with a warning about the immorality of continuing on the current course,

The results of clinical trials are a public, not a private, good. The public interest requires that we have a complete view of previously conducted trials and a mechanism to correct the record for inaccurately or unreported trials. If we do not act on this opportunity to refurbish and restore abandoned trials, the medical research community will be failing its moral pact with research participants, patients, and the public. It is time to move from whether to how, and from words to action.

Thus the notion that suppression and manipulation of clinical research is a systemic, severe problem that confounds health professionals and hurts patients is no longer a concern of only a few fringe dissidents, but a matter for discussion in the foremost mainstream medical journals.

Will Anyone Heed the Call?

Furthermore, this dire problem formulation suggests the need for a strong solution, as proposed by the article, and seconded by the editorial.  Using the term "abandoned trials" for " unpublished trials for which sponsors are no longer actively working to publish or published trials that are documented as misreported but for which authors do not correct the record using established means such as a correction or retraction (which is an abandonment of responsibility)," Doshi and colleagues wrote,

We call on institutions that funded and investigators who conducted abandoned trials to publish (in the case of unpublished trials) or formally correct or republish (in the case of misreported trials) their studies within the next year.

Starting in 2005, we have repeatedly called for protection of " researchers' rights to speak truth to power," but then noted that "right now, it is more often power that speaks to truth."  The question is whether without some bigger allies, individual clinical researchers will stand up on their own to restore the integrity of clinical research.

The big reason to worry is that most of these researchers work within a context which strongly favors vested interests, rather than scientific truth, or the rights of research subjects.  The researchers who would be most likely to be able to heed the call by Doshi et al are those within academic medicine. Yet clinical research in the academic medical world now functions within a strong and deep web of individual and institutional conflicts of interests, subjects that we also have written about incessantly.

There is evidence suggesting that the majority of medical faculty,(4) and the majority of their academic departmental leaders(5) have important financial ties to the health care corporations most likely to have reason to want to suppress or manipulate research.  Furthermore, most academic medical institutions have stated their interest in increasing "collaboration" with industry, usually giving the rationale that this will lead to "innovations" that will bring better tests or treatment to patients. (See posts here,  here and here for some examples.)  Such collaboration also tends to bring a lot of money to institutional budgets.  Further collaboration with industry is likely favored by academic leaders' own financial ties to the same sorts of corporations discussed above.  Thus it should be no surprise that a study by Mello et al in 2005 suggested that most of the managers of academic medical institutions who control research contracts are willing to give significant control of of research design, implementation, analysis, and dissemination to the sponsors, not the researchers.  (See this post.) (6)


Thus, a researcher who volunteers to restore suppressed or manipulated clinical studies might become suddenly very unpopular with his or her colleagues or supervisors, and perhaps with people who are already paying him or her.

So as long as health care professionals, policy makers, and the public at large are willing to go along with the notion that academic medical institutions' "collaboration" with "industry" is absolutely necessary to foster "innovation" and hence medical progress, it is very unlikely that academic medical researchers will be willing to help restore the integrity of clinical research.  In fact, while we continue on our present course, the integrity of clinical research will probably get even worse.
 
Since questioning the integrity of contemporary clinical research might make those with vested interests who have been willing to suppress or manipulate research very uncomfortable, perhaps it should be no surprise that the paired articles in the British Medical Journal have been relatively anechoic.  For example, while one might think the publication of these simultaneous articles might get at least a little coverage in the "main-stream media," I can find not a single mention of them there.  (So far, only the Chronicle of Higher Education, MedScape the Science Insider blog and The Scientist blog have provided news coverage.)


So I hope the brave people who wrote the article and editorial are also willing to join us in decrying the web of individual and institutional conflicts of interest that have entangled health care professionals and academic medicine.  Individuals and institutions who make medical or health care decisions, or who are involved in medical and health care education and research should reveal all their conflicts of interest, at least in the interests of honesty.  Furthermore, in the interest of patients' and the public's health, clinical research meant to assess medical tests, treatments, and programs should be done completely independently from the corporations that sell them.  


References

1.  Poses RM.  A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link here..
2.  Doshi P, Dickersin K, Healy D et al.  Restoring invisible and abandoned trials: a call for people to publish the findings.  Br Med J 2003;  BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2865  Link here.
3.  Loder E, Godlee F, Barbour V et al.  Restoring the integrity of the clinical trial evidence base.  Br Med J 2003;  BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3601  Link here.
4. Campbell EG, Gruen RL, Mountford J et al.  A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.
5. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786.  Link here.
6.  Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352:2202-2210. Link here.

Oh, the Prices we Pay ... for Questionable Drug Marketing to Enrich Corporate Insiders - the Case of Questcor's H P Acthar Revisited

In 2007, we first discussed the case of the amazing pricing of H P Acthar, a very old drug of questionable usefulness, as an example of the irrationality of health care prices in the US, and of the failure of the organizations that ought to resist outrageous pricing in our mixed, pseudo-market based health care system to do so.  A recent New York Times article has updated this case.

Background

As we wrote in 2007, ACTH (adrenocorticotrophic hormone) is a naturally occurring hormone that stimulates the activity of the adrenal gland, which produces cortisol and other glucocorticoid and mineralocorticoid hormones.   ACTH produced from pigs' adrenals was first marketed as a biologic agent in the 1940s.  It was used for some conditions that appear to benefit from the effects of increasing cortisol production induced by ACTH.

It has been traditionally used to treat infantile spasms, a rare but distressing condition, and exacerbations of multiple sclerosis (MS).  However, since the drug was introduced so long ago, it was never subject to rigorous controlled trials to assess its efficacy and adverse effects for these indications.  Furthermore, since the 1940s, synthetic glucocorticoid hormones have become widely available as generic drugs.  Yet these slightly newer drugs have never been rigorously compared to ACTH for infantile spasms or MS.  The most recent review (edited in 2009) by the Cochrane Collaboration found that steroids and ACTH have some evidence in their favor for the treatment of acute MS, but found no evidence showing that ACTH was superior.  [Filippini G, Brusaferri F, Sibley WA, Citterio A, Ciucci G, Midgard R, Candelise L. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.: CD001331. DOI: 10.1002/14651858.CD001331].  Also, the most recent review (edited in 2009) of treatment of infantile spasms concluded, "it is not clear which treatment [including ACTH] is optimal." [Hancock ED, Osborne JP, Edwards SW. Treatment of infantile spasms.  Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No. : CD001770. DOI: 10.1002/14541858.CD001700.pub2.]

The Pricing of H P Acthar

Possibly because some physicians thought ACTH might be useful for some patients with two conditions, infantile spasms and acute exacerbations of MS, ACTH has remained on the market.  It was manufactured by a single company, Aventis, (now part of Sanofi-Aventis), the successor to Rhone-Poulenc-Rorer.  In 2001, Aventis sold the rights to manufacture ACTH, with the trade name H P Acthar, to a new, small biotechnology company, Questcor.  In 2007, Questcor raised the price of ACTH from $1650 per vial to more $23,000 per vial.  That got the attention of the Philadelphia Inquirer, on whose article we based our commentary. We used the price increase as an example of how pricing in health care has become untethered from any sort of clinical reality, and wondered why insurance companies and the US government seemed willing to pay this outrageous price for an old drug with little evidence from clinical research to support its use.  But the issue then seemed, like many others we have discussed , to become anechoic, until the very end of 2012.


Now the  New York Times story has provided an example of how health care corporations can do very well without doing anyone, except corporate insiders, much good.  It included instances of many of the kinds of ethically questionable practices we have discussed over the years on Health Care Renewal.

Deceptive Marketing

Per the NY Times,

Questcor did almost no research or development to bring Acthar to market, merely buying the rights to the drug from its previous owner for $100,000 in 2001. And while the manufacturing of Acthar is complex, it accounts for only about 1 cent of every dollar that Questcor charges for the drug.

Moreover, the tiny 'orphan' market soon became much bigger. Before long, Questcor began marketing the drug fo multiple sclerosis, nephrotic syndrome and rheumatologic conditions, even though there is little evidence that Acthar is more effective for those other conditions than alternatives that are far cheaper. And the company did so without being required to prove that the drug actually works. That is because Acthar was approved for use in 1952, before the Food and Drug Administration required clinical trials to show a drug is effective for a particular disease. Acthar is essentially grandfathered in. 

Today, only about 10 percent of the drug’s sales are for infantile spasms. The new uses, Mr. Bailey has told analysts, represent multibillion-dollar opportunities for Acthar and Questcor, its sole maker. 

The results have been beyond even the company’s wildest dreams. Sales of Acthar, which accounts for essentially all of Questcor’s sales, totaled nearly $350 million in the first nine months this year, up 145 percent from the period a year earlier. In the same period, Questcor’s earnings per share nearly tripled, to $2.12. In the five years after the big Acthar price increase in August 2007, Questcor shares rose from around 60 cents to about $50, in one of the best performances of any stock in any industry. 

So Questcor leadership was clever enough to use loopholes in the law to promote ACTH for particular kinds of patients without any good evidence that it did those patients any good.  Furthermore, Questcor used several questionable tactics 

in this promotion.

Manipulated Research

Apparently Questcor leaders decided they needed some sort of minimal research results to promote their products, so as the Times reported,

Because Acthar was approved for these conditions decades ago, Questcor has not had to do large clinical trials to show that the drug works. It has paid for some small studies, mainly by individual doctors, who then publish a paper that the sales force can present to doctors. 

The study that justified calling on rheumatologists involved five patients with rare conditions, all of them treated by a single doctor. All the patients had much improvement on Acthar after failing to benefit from more standard therapies, the doctor, Todd Levine, said in a Questcor conference call.

Too call the research Questcor sponsored minimalist would be too polite.  A case series of five patients, lacking any control group proves almost nothing.  It proves less when the research is done in an unblinded  fashion by a single doctor who presumably was invested in the outcome being favorable for his sponsor's product.  (I suppose some might quibble with calling this research manipulated, but I contend but doing such crude research when it would be possible to do something much more credible amounts to manipulation.)

Suppression of Research

Moreover, it seems that even such rudimentary studies sometimes failed to produce the wanted results.  In these cases, the Times reported that Questcor simply suppressed them.

Still, it appears that at least a couple of small studies that may have raised questions about the drug have been suspended. 

'From my standpoint it just didn’t work,' said Dr. Sungchun Lee, a Phoenix nephrologist who stopped a small study testing Acthar as a treatment for nephrotic syndrome. 'I think they were O.K. with me stopping because we weren’t getting the results,' he said. 

Another study that was terminated sought to determine whether multiple sclerosis patients who did not have a good response to steroids should be treated with either another round of steroids or with Acthar. The study was halted midway through 'to analyze data,' according to the summary of the trial on the federal clinical trial database. 

Use of Paid Key Opinion Leaders

Despite the lack of good clinical evidence in support ACTH, there are some physicians who defend its use.  One example in the Times article was a physician who is paid by Questcor

But some doctors say Acthar can be effective in cases that are not well treated by steroids. They say that there is emerging evidence that Acthar does more than just stimulate the body to produce its own steroids. 

'It really looks like the ACTH does bring something different to the table that standard steroids don’t,' said Dr Ben W Thrower, director of the multiple sclerosis institute at the Shepherd Center, a hospital in Atlanta. Dr. Thrower, who is a paid speaker for Questcor, said his institute had tried Acthar for about 60 of its 3,000 patients, ones who did not respond to steroid treatment. Acthar made the symptoms subside in about half of them.

Where to begin?  Just because ACTH is different does not mean it is better.  Since MS is a disease whose symptoms wax and wane, patients who fail standard treatment may get better on their own, and without a control group, it is impossible to say whether the ACTH given to such patients was the reason they got better. 

Creation of Institutional Conflicts of Interest for Disease Specific Foundations

Questcor's ACTH also has support from a disease specific foundation, but one that Questcor has also supported financially.

Dr Lawrence Brown, a neurologist at the Children's Hospital of Philadelphia, and the president of the Child Neurology Foundation, says of Questcor: 'They have gone out of their way to help every kid who needs the medicine to get it quickly and efficiently.'

This year, the foundation awarded its first corporate citizenship award to Questcor. Dr. Brown says Questcor’s donations — the amount has not been disclosed — to the foundation didn’t influence the award.

Who could be so naive to think that giving an organization funding might influence its actions?  After all, human response to financial incentives is the basis for most current economic thinking.

Insiders Get Rich

Admittedly, these questionable tactics did lead to an increase in "shareholder value,"  As the company's proxy statement boasted in 2011,

While we generated strong financial returns in 2011, we are most proud of our patient focus and investments in Questcor which we believe will generate sustainable value to our shareholders, employees, patients and all of the communities that we serve. We believe that our patient focus and commitment to generating sustainable value to all of our constituencies results in strong value creation for our shareholders.

However, as of today, Qustcor's share price has dropped to $26.74 from a peak of 53.42 in June, 2012, with most of the drop in December, 2012, around the time the Times article came out, according to Google Finance.  So whether share holder value will turn out to have increased in the long run is not clear. 

Meanwhile, some Questcor employees did very well.  The largess started with some drug representatives,

Questcor sales representatives who are lucky enough or skillful enough to have a big prescriber in their territory can reap bonuses of $50,000 a quarter, according to former employees of the company.

More highly placed corporate insiders did even better.

Executives are paid well, too. In 2009, Mr. Bailey, [the CEO]  hired his daughter Kirsten Fereday as director of business analytics and evaluation, a job that paid $275,000 in cash and stock last year. 

 Left out of the Times article, somewhat surprisingly, was what the top executives make.  Information from up to 2011 is publicly available, however, in proxy fillings.

In the company's 2012 proxy statement, we find the following figures for total compensation:
Don M Bailey, President and CEO - $4,546,230, up 192% of his compensation in $1,554,503 in 2009
Michael H Mulroy, Senior Vice President, Chief Financial Officer and General Counsel -  $1,749,891 (his first year)
Stephen L Cartt, Chief Operating Officer -  $2,298,308, up 168% from $855,460 in 2009
David J Medeiros, Executive Vice President and Chief Technical Officer - $1,232,556, up 78% from $692,188 in 2009
David Young Pharm D, Chief Scientific Officer - $1,948,804 up 182% from $1,066,159 in 2009

In addition, by 2011, Mr Bailey, the CEO, had acquired 1.92% of the company's total stock, 3,834,910 shares, today worth $102,545,490.

Finally, per the Times,

one group of shareholders has done pretty well for itself. Over the last two years, as the company’s share price mainly soared, Questcor insiders have sold more than $100 million of stock. 

Summary

 So, in summary, a small biotechnology company drastically increased the price of its only product, a drug which has never been subject to modern clinical trials, and whose efficacy has never been proven.  Its marketing tactics have included manipulation and suppression of research, and payments to physicians and non-profit organizations.  Although its most breathtaking price increases were made in 2007, they attracted little public attention until five years later.   Meanwhile, corporate insiders, from drug representatives to top executives and their relatives, have done very well for themselves.

In the US, there a lot of people who advocate free market based health care for its efficiency and innovation.  For example, see "Yes, Mr President, a Free Market Can Fix Health Care," published by the Cato Institute, in which its Director of Health Policy Studies proclaimed, "The great advantage of a free market is that innovation and more prudent decisionmaking means that fewer patients will fall through the cracks," and then "a free market can and would control costs, expand choice, improve health care quality, and make health coverage more secure." [italics added for emphasis]

Unfortunately, the case of Questcor's ACTH makes it seem that in the current US system, which is supposedly more market based than systems in many other countries, the efficiency and innovation is characteristic of the marketing of corporate health care, not of the health care itself.  Here is a stellar example of how clever, and not always very scrupulous marketing can be used to sell a very old drug with little demonstrated clinical value for a stratospheric price, enriching corporate insiders, perhaps enriching stockholders (although, not so much lately, and we will see how they do in 2013), at the expense of the public who pays taxes and insurance premium.  This case suggests a need for more attention to market failures and less insistence on market fundamentalism.  Of course, it also suggests the continuing need for health care professionals, policy makers, patients and the public to be extremely skeptical about heavily promoted commercial health products.

The Parts of Professionalism We Are Not Supposed to Discuss

A recent article in a a relatively obscure medical ethics journal dared to approach some important aspects of medical ethics that medical ethicists fear to discuss, but did not address the reasons for this fear or what to do about it. (Glenn JE. The eroding principle of justice in teaching medical ethics.  HEC Forum 2012; 24: 293-305.  Link here.)

The Basic Ethics Case - A Prescription for the Patient's Spouse?

Glenn began with a case typically discussed in medical school ethics courses:

a scenario where a standardized patient asks the student at the end of the examination if his prescription can be written in his spouse’s name as the spouse has health insurance which includes prescription drug coverage while the patient does not.

This

poses the question as to whether it is ethical for physicians to deceive third party payers to secure coverage for their patients.

The Politically Correct Way to Teach the Case

Glenn stated that there is a politically correct way for faculty to teach this case:

 Though we are never expressly instructed to tow [sic] a party line, there is a 'correct' answer to this ethical quandary as far as the institution we work for is concerned. Students who express a willingness to practice deception of third party payers for the good of their patients are to be commended for having their heart in the right place. However, we discuss many reasons why this action would not be a good solution to the problem. One of the issues is that to do so would be committing fraud.

Now, of course, writing a prescription for a patient who does not actually need the drug in question, understanding that the patient will give the drug to someone else who does not have insurance coverage to pay for it, is dishonest.  However, the larger point that Glenn made is that it is not politically correct to allow discussion about why the patient made such a request in the first place, and that this ought to be troubling.

Note that Glenn did not explain how he inferred what the "correct" answer was, nor its actual source within the institution.

Over the first few years of having this conversation with young medical students, I have always come away feeling empty and flat. Framed as a session on the ethics of 'truth telling,' the conversation and the readings we provide to prepare for it works to obfuscate the much larger ethical issue impossible to tackle in an hour’s time. In essence, 'truth telling' is only a secondary ethical issue at play. The more important ethical issue is a question of social justice: what commitment do doctors have to poor patients and making sure that they get the health care services that they need?

Social Justice as Part of Professionalism, and its Avoidance

The article by Glenn then emphasized that some of the original conceptions of physicians' professionalism included social justice.  A definition promulgated by Herbert Swick in 2000 expressly included these relevant competencies.  Physicians ought to:
-  subordinate their own interests to the interests of others
-  respond to social needs and work toward the benefit of the communities in which they live and serve
-  adhere to the core humanistic values of honesty and integrity, compassion, altruism, empathy, respect for others, and trustworthiness.


Glenn noted that these three competencies, however, have been turned into a more narrow imperative, that

doctors should treat patients with an equally high quality irrespective of their race, ethnicity, gender, religion or cultural background according to what is best for them. In most codes of professionalism, however, class is not expressly implicated.

Note that Glenn did not question why the issues of race, ethnicity, gender, religion, or cultural background became important in this context.  He did further question why the issue of class did not.  While

 The professionalism code adopted by the American Board of Internal Medicine in 1999 was bolder and specifically states that doctors are to advocate for 'the best possible care [for their patients] regardless of the ability to pay'

Glenn asked

 But where in the medical school curriculum do we teach medical students to be strong patient advocates and take on third party payers and hospital administrators? We now discuss the importance of prescribing generic drugs and we warn against the influence of big pharma, but when do we teach students to rebel against the high cost of medical education that drives students toward boutique medicine and fields of specialty care that offer the most money and most comfortable lifestyles?

Furthermore, he noted,

 When it comes to justice in medical ethics instruction, the parameters of the discussion are usually constricted to focus on the conservation of health care resources and rationing care rather than providing more care to more patients.

So, now seemingly getting to the key question,

We have created an entire system where all the middlemen that stand between a patient and her health care are expecting to get rich. No oath or professionalism curriculum is structured to teach medical students how to ethically and morally navigate through that. How did the terms of the debate get so co-opted by the health care economists?

The Key Question also Avoided

However, after this build up, Glenn then had trouble grappling with that question.  He noted that the prices of various parts of US health care are rarely questioned, and wrote about some of the particular issues in pricing new technologies, including the costs of development of new drugs, the tax treatment of drug development, and whether the licenses drug companies obtain from universities to develop drugs are fairly priced.  He also touched on the rising cost of medical school tuition and students' consequent assumption of large levels of debt.  This was interesting, and provided some useful references, but never really directly addressed the key questions above: why was the discussion framed in terms only of current health economics, and more importantly,  why did he and other ethicists feel they could not openly discuss any larger issues?

Only at the very end of the article did this appear

the structure of our current medical system has created a network of health care providers, researchers, purveyors and administrators who have strong financial incentives to work against the best interests of patients. This situation makes it difficult to talk with students about the ethical principle of justice in any meaningful way that is not hypocritical, leaving it seldom emphasized relative to the other three core principles of medical ethics.

Glenn did not further explain these "financial incentives," detail further who had them, explain how they "work against the best interests of patients," and most importantly, explain how these incentives make "it difficult to talk with students about the ethical principal of justice in any meaningful way that is not hypocritical."  He concluded only

 How can we cultivate within our students an understanding of the threats to medical professionalism posed by the conflicts of interest inherent in the various financial and organizational arrangements in the practice of medicine?  We start by not shying away from the conversation.

Summary

So Professor Glenn argued that social justice has been considered part of health care ethics, and that ethicists should teach about it by questioning the current economic arrangements within the health care system.  He then suggested that ethicists have been somehow pressured not do raise such questions, and that this pressure has something to do with perverse incentives and conflicts of interest prevalent within health care.  However, he never actually addressed who pressured the ethicists, how the pressure was applied, and how that pressure was related to conflicts of interest.

Thus, it seems that authors in scholarly health care journals may now hint that there are certain things one must not discuss, that are taboo to discuss in health care, but cannot actually say what exactly is taboo, and why it became that way.  Thus, the article by Glenn seems related to what we sometimes coyly call the "anechoic effect,"  that the issues we discuss on Health Care Renewal often do not seem to be considered topics of polite conversation.  But in a strange recursive way, the article never could quite manage to discuss what it is it said others cannot discuss, which in a way just further validates the importance of the anechoic effect.

The Glenn article is reminiscent of another article we posted about.  That article, by Souba and colleagues,  found that there are many "elephants," that is,  unmentionable subjects, in academic medicine,  However, that article also never clearly defined what these unmentionable subjects actually are, other than subjects that displease those in power.  Thus this too reinforced just how taboo these topics are.  Even those willing to admit that taboo topics exist are still unable to name them.

At least the Glenn article did suggest, however vaguely, a relationship between conflicts of interest and the anechoic effect.  We have documented that individual and institutional conflicts of interest are rampant in health care, including, and probably particularly academic medicine.  For example, pharmaceutical companies (and also all sorts of other health care corporations) may pay medical school faculty members and administrators (as consultants, "key opinion leaders," speakers, advisers, even board members).  The leaders of academic medicine seem particularly prone to such conflicts. For example, a majority of US medical school department chairs have significant financial relationships with health care corporations (see post here).  We have shown how top medical school leaders may simultaneously serve on the boards of directors of health care corporations (see post here). Such health care corporations may now also support various aspects of medical academia (through research grants, "unrestricted" and other educational grants, other gifts to hospitals and universities, etc).  Financial conflicts of interest may help to directly enrich many faculty and academic leaders, and indirectly enrich them by enriching their organizations. People who are personally profiting from relationships with health care corporations are unlikely to question such relationships.  The leaders of organizations which depend on funding from such corporations are unlikely to question whether conflicts of interest might lead to corruption.  People whose colleagues, friends, family members, or supervisors are personally benefiting from conflicts of interest may hesitate to challenge such relationships.   Since these relationships permeate the economics of health care, is it any wonder that the entire topic has become taboo?  

So the first step in challenging this taboo is to acknowledge it exists, and to not "shy away" from discussing it, as Glenn suggested.  People are beginning to acknowledge there is an elephant in the room.  Now we have to describe the elephant, discuss the elephant, and eventually figure out how to get the elephant out of the room.     

Hat tip - to the Medical Professionalism Blog.