American Medical Schools Are "Only In It for the Money" Say Their Faculty

We recently discussed the plight of young medical faculty.  It appears that their plight is even worse than we imagined.

Last month, an abstract was presented at the Annual  Conference on Research in Medical Education at the Annual Meeting of the Association of American Medical Colleges, in a session entitled "Your Career is More than Your Specialty."  The citation would be: Pololi L, Ash A, Krupat E.  Faculty Values in the Culture of Academic Medicine: Findings of a National Faculty Survey.

The authors described a large survey, of over 5000 faculty at 26 US nationally representative medical schools, done as part of the National Initiative on Gender, Culture, and Leadership in Medicine (known as C ‐ Change) project.  The overall response rate was good (53%).   Here are the striking results:

51% agreed that 'the administration is only interested in me for the revenue I generate'; 31%; that 'the culture of my institution discourages altruism'; 31%, that other people have taken credit for my work'; and 30% that 'I am reluctant to express my opinion for fear of negative consequences.' Half perceived that the institution does not value teaching and 27% that it does not reward clinical excellence; Over half disagreed with the statement that their own values are aligned with those of the institution. Also, 30% had seriously considered leaving academic medicine and 46% their own institution, both in the prior year.

These results show that US medical education is in moral crisis, and probably close to catastrophe.  These results should provoke shame and outrage, and cause widespread discussion. On the other hand, it is remarkable that they were allowed to see the light of day at all, given the persistent strength of the anechoic effect.  Pololi and colleagues obviously never got the message that one is never ever supposed to discuss such things in public.

Instead of being about discovery and dissemination of knowledge, the fundamental mission of education, a majority of large sample of faculty surveyed says American medical schools are about making money.  Instead of putting teaching first, half of the faculty said their institutions explicitly do not value teaching. Instead of supporting free speech, free enquiry, and academic, a significant minority of faculty say that are afraid to speak out.

It is no wonder that nearly half of the faculty are considering leaving.

On Health Care Renewal, we have discussed evidence, mostly anecdotal, about the rot within the foundations of medicine and health care.  (Note, posts on conflicts of interest, often affecting medical school faculty and leadership, are here; we have posted about how academic medicine has often allowed suppression and manipulation of research;  posts on excessive compensation of health care executives, including those of academic institutions, not based on upholding the academic mission are here.)  Now it appears that the rot is so severe that the whole edifice is about to fall down.

Our foolish transformation of the calling and profession of medicine into a business (see posts here and here)  at a time when businesses were taken over by the arrogance, greed, unscrupulousness, and amorality that lead to the global financial collapse will surely also lead to a global health care collapse if something is not done very soon.

We need a new effort much bigger than but at least as influential as the Flexner Report to re-imagine academic medicine again as valuing teaching, learning, research and patient care, while regarding its financing only as the means to reach those ends.

The Carnegie Foundation sponsored the original Flexner Report, and the Rockefeller Foundation then hired Dr Flexner to reform medical education (see Mitka M.  he Flexner Report at the century mark:  a wake-up call for reforming medical education .  JAMA 2010; 303(15):1465-1466. Link here.) Will anyone or any organization have the courage to sponsor a new, bigger, and likely much more contentious effort?

Meanwhile, the academic leaders who have personally profited from and colluded with the transformation of the system into one that is only in it for the money should resign. The few remaining leaders will need to draw upon all their honesty, integrity, knowledge, and determination to rebuild the system.

Finally, shame on all of us for letting us get to this place.

With apologies to the late Frank Zappa and the Mothers of Invention.

A Confidentiality Clause or an Oath of Fealty?

The advancement of modern scientific medicine depends on the search for and dissemination of truth. Academic medicine, like the rest of academia, ought to be based on openness, transparency, and academic freedom. The 1940 American Association of University Professors (AAUP) Statement of Principles on Academic Freedom and Tenure opened with:

The common good depends upon the free search for truth and its free exposition.

Yet we have written about dark clouds of secrecy spreading over medicine and health care. The increasingly powerful leaders of health care increasingly use opacity and secrecy to keep what they are doing out of the public eye. We have frequently discussed the anechoic effect, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  People may feel it is unseemly to speak badly of renowned institutions such as hospitals and universities.  People with conflicts of interest may not be inclined to criticize those who pay them.  Now people employed by contemporary health care organizations may have to pledge theri silence to keep their jobs.

The latest story in this regard comes from Virginia Commonwealth University (VCU), which includes VCU Health Systems, and MCV Hospital and Physicians.  (Full disclosure: I was a VCU full-time faculty member from 1987-1994, and still am on the adjunct faculty.)  In 2008, the VCU President resigned after the university's secret research contract with a tobacco company, and the President's own position on the board of directors of another tobacco company were revealed (see blog post here and others here).

Michael Rao, the President since 2008, is now under outside review after it was revealed that he required his staff to sign a secrecy pledge.  The story appeared in the Richmond Times-Dispatch:

Virginia Commonwealth University President Michael Rao asks employees who work in his office to sign an unusual confidentiality agreement that bars them from talking about what they observe about him or his family.

The prohibition goes beyond the standard agreement that university employees sign acknowledging that they can't disclose personal or proprietary information.

The agreement, a copy of which was obtained by the Richmond Times-Dispatch, covers interactions at Rao's office and at his residence. It bars disclosure not just to the news media, family or friends, but also to colleagues, 'clergy and attorneys, or to any other person not otherwise identified.'

'I agree that any such disclosure in violation of this nondisclosure agreement could result in irreparable damage and harm to VCU, President Rao, and/or his family'" the agreement states. 'Any such violation or anticipated violation' would entitle Rao to seek 'injunctive relief' in Richmond or Henrico County circuit courts.

VCU spokeswoman Pam Lepley said she could not comment immediately yesterday.

Several current or former employees of the president's office confirmed that they had been asked to sign the agreement, including Kimberley Busch, Rao's former scheduler.

She described it as a 'what happens in the president's office stays in the president's office' agreement.

The newly uncovered confidentiality clause provoked strong criticism:

Raymond D. Cotton, a Washington attorney who specializes in higher-education governance, said such a confidentiality agreement is highly unusual and goes against the culture of openness and transparency in higher education.

'There is this concept of academic freedom that is broader than the First Amendment,' he said.

In fact, since Virginia Commonwealth University is a state-supported institution, the confidentiality clause may be unconstitutional, as reported by WTVR:

Kent Willis with the Virginia American Civil Liberties Union said the agreement doesn't pass constitutional muster.

'A public employee, no matter where they are in the government, has a right to speak out on matters of public concern,' Willis said. 'That's a U.S. Supreme Court case, it's guaranteed to every public employee by the First Amendment to the Constitution.'

Willis said there are numerous legal issues raised by the contract. But, he said, the bottom line problem with the contract 'is the attitude. This is a contract that says 'I'm not transparent. I don't want you to know what is going on. I'm running a closed shop.''

Times-Dispatch columnist Michael Paul Williams wrote:

VCU, we have a problem. This confidentiality agreement does not inspire confidence. The lack of transparency only gives the appearance that someone's hiding something.

He also further quoted Kent Willis:

Rao's contract 'fails to address this whistle-blower right and could create conflicts for employees, who are silenced by the employment contract,' yet have a constitutional right to speak out on some matters, Willis said.

And as Willis points out, even if a person's constitutional right trumps the contract, how many employees are willing to take that risk?

'Particularly disturbing is the prohibition against talking to an attorney,' he said. 'If an employee believes something illegal is going on at work, an attorney is precisely the person he or she should be talking with.'

We just posted about how a pharmaceutical company included a confidentiality clause in a consulting contract, suggesting the deliberate creation of a conflict of interest in order to prevent criticism of the company's products or practices. 

However, in several ways, the present example is more insidious.  First, it involves a university, whose mission is to discover and disseminate the truth.  Thus, as noted above, the confidentiality agreement subverts the university's core mission.  Second, it was required of full-time employees who wanted to keep  their jobs, making choose between secrecy and unemployment.  Third, it was particularly harsh, addressing incipient as well as actual disclosure, and including injunctive relief as well as the threat of  termination.  Fourth, it protected not just the organization and its products, but personally protected the organization's leader and his family.  It was not just a contract, but an oath of fealty, as if the CEO were nobility, or even royalty.

The good news is that this confidentiality agreement now sits in the glare of sunlight.  One does wonder, however, how many other such agreements are already in force so that the would be nobility who now run too much of health care to avoid any embarassing revelations about what their leadership really is about.

We are a long way from the transparency that true health care reform requires. 

"We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

In my post "Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development" I reported on the Univ. of Sydney's somewhat belated support for academic freedom, and the reappearance of an essay on ED electronic health records problems in NSW by one of its informatics faculty, Prof. Jon Patrick, after an apparently government-initiated attempt at censorship.

A new update of the paper "A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck" version 6, has now been posted by Dr. Patrick at this link on his department's web pages (a direct link at this time to the PDF is here).

The press has started to take notice. A piece in the Sydney Morning Herald entitled "Health department accused of censorship" appeared on Nov. 28 here.

That piece was noted by Computer Weekly in the U.K. in a piece entitled "Claim of censorship over Cerner system" here. The U.K. suffers a severe EHR epidemic (the UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.)

[12/3/09 update: the piece has disappeared, then reappeared, at Computer Weekly. In case it disappears again, a copy of the article from Google's cache is here.]

From the U.K. Computer Weekly article:

The Sydney Morning Herald and ZDNet in Australia report that the University of Sydney removed from its website - temporarily - a negative essay about a Cerner system which had been installed at hospitals in New South Wales.

The author of the essay is a medical IT professor, Jon Patrick, who is reported to have claimed that NSW Health, which is part of the government of New South Wales, put pressure on the university to take down the paper.

If true, it would tie in with what's been happening in England where mentions of Cerner in a negative context are being officially discouraged.

Cerner is due to be installed at hospitals across London as part of the National Programme for IT [NPfIT] but several trusts that have already gone live - including the Royal Free and Hampstead, Barnet and Chase Farm, and Barts and The London - have run into serious problems, including the losing of patient appointments and patients not being treated.

A showcase Cerner site at Homerton ceased mentioning Cerner in its public board papers after doing a deal with NHS Connecting for Health and the Department of Health. Homerton also rejects FOI requests related to its discussions on Cerner.

Homerton told me: "We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence."

I am repeating that last sentence for effect:

We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence.

This is solid evidence of such confidentiality clauses in HIT contracts and the chilling effect they have, along with dangers of "hold harmless" clauses. This style of EHR contracting is a practice now under investigation by the U.S. Senate Committee on Finance, as in their Oct. 16, 2009 letter to major healthcare IT vendors and management consultants from Senator Charles E. Grassley (ranking member). A copy of that letter is here (PDF).

I have written on the dangers of such clauses before as in my July 22, 2009 letter in the Journal of the American Medical Association "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (http://jama.ama-assn.org/cgi/content/extract/302/4/382), as well as my much more thorough posting on these issues in the essay at my Drexel University website here.

In that essay I observed:

Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses, I also question whether hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well ...

Let's look at the Joint Commission Hospital Accreditation Program Leadership Chapter, and its standards for hospital leadership (link, PDF):

Leadership
LD.01.03.01

Standard LD.01.03.01
The governing body is ultimately accountable for the safety and quality of care, treatment, and services.

Rationale for LD.01.03.01
The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality.

The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks.

How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly?

Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians.

Elements of Performance for LD.01.03.01
5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services.

One of those resources is health IT.

Standard LD.02.01.01
The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services.

Rationale for LD.02.01.01
The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization].

How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes?

Standard LD.02.03.01
The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality.

Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor?

Rationale for LD.02.03.01
Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves.

I ask the same question as above.

Standard LD.03.01.01
Leaders create and maintain a culture of safety and quality throughout the [organization].

Safety for whom, exactly? Patients, or patients and staff?

How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality?

How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality?

How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT?

Standard LD.03.04.01
The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties.

Rationale for LD.03.04.01
Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience.

Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service?

This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories here).

Standard LD.04.04.03
New or modified services or processes are well-designed.

... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients.

4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards.

How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose?

Standard LD.04.04.05
The [organization] has an organization-wide, integrated [patient] safety program.

... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.

Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is.

The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions.

International scandal, indeed.

I predict these EHR confidentiality clauses will end up causing great loss of money in failed systems, and/or harming patients, due to the chilling effect they have on revelation of defects and problems by clinicians and executives alike.

Those who signed them will very likely be held liable, at least in the U.S., as the clauses breach the safety standards of the accrediting agency for hospitals here, the Joint Commission. I wish the signers of such contracts good luck in the courtroom.

In Australia and the U.K., I cannot comment, but also wish good luck to those who signed these clauses when lawyers go full court press on EHR-mediated debacles.

-- SS

No Free Speech for Comparative Effectiveness Researchers?

We have repeatedly argued why comparative effectiveness research, under ideal circumstances, would be a good idea.  As I said before:

Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only studies done compared individual treatments to placebos, and when even those were restricted to narrow patient populations unlike those patient usually seen in daily practice, physicians are left juggling oranges, tomatoes, and carburetors.

Comparative effectiveness studies are simply studies that compare plausible treatments that could be used for patients with particular problems, and which are designed to be generalizable to the sorts of patients usually seen in practice. As a physician, I welcome such studies, because they may provide very useful information that could help me select the optimal treatments for individual patients.

Because I believe that comparative effectiveness studies could be very useful to improve patient care, it upsets me to see this particular kind of clinical study get caught in political, ideological, and economic battles.

However, when comparative effectiveness research was proposed as an element of US health care reform, it was attacked as a vehicle for the dreaded rationing of health care (even though in the US health care is already rationed, especially to those without generous insurance or the means to pay for expensive tests and treatments), using arguments based more on emotions, or outright fallacies than on logic and evidence. For example, see our blog posts here, here, here, and here.

Those opposed to the sort of comparative effectiveness research I described above then seemingly decided, "if you can't beat 'em, join 'em."  Thus, a provision appeared in a recent version of health care reform legislation proposed in the US Senate for comparative effectiveness research to be sponsored by an "independent" institute whose board of directors would have to include a substantial minority of representatives of industry (that is, drug, biotechnology, device, health insurance corporations, and other corporations as "payers.")  This would seems to be a fairly shameless form of "regulatory capture," that is, an instance in which a government agency whose mission seems to be to improve health care is "captured" by those with vested interests in promoting certain health care products and services.  (See post here.)

My concern has now seemingly gone mainstream, in that it was addressed in a commentary published on-line in the prestigious New England Journal of Medicine.  [Selker HP, Wood AJJ.  Industry influence on comparative-effectiveness research funded through health care reform.  N Engl J Med 2009.  Link here.]

Selker and Wood addressed the issue of regulatory capture thus.

Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research.

The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee

Note that the situation is worse considering that the insurance industry and other "payers" also have seats on the board.

However, Selker and Wood discovered an even more outrageous provision:

The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not within the bounds of and entirely consistent with the evidence.' Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome.

As Selker and Wood noted, it is unprecedented for a US government agency that is meant to sponsor science to be empowered to punish researchers for conclusions or opinions with which the agency disagrees. This suggests that the new agency would be meant to produce only results that support the vested interests of its leadership, that is, that favor the latest, and most expensive drugs and devices. The research sponsored by such an agency would not only be biased, it would likely be of poor quality, because researchers of integrity would likely avoid sponsorship by an agency that would be so threatening to their scientific independence.

This part of the bill does not promote health reform, but blatantly attempts to serve health care corporations while sacrificing the interests of patients and doctors.

As Selker and Wood politely put it:

If health care reform legislation does not promote CER that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research. This outcome would be extremely unfortunate, since such research has the potential to improve patients’ lives by leading to more effective medical care. The U.S. biomedical research enterprise has a long and storied history that has made it a model for other countries. It would be a tragedy if we were to squander its achievements for political expediency, in the service of short-term commercial interests. The current proposals for controlling CER in a manner unlike anything we have seen in federally sponsored biomedical research therefore should be rejected.

It seems to be almost gilding the lilly to note that the provision cited above seems to violate the free speech and free press provisions of the 1st amendment of the US Constitution, since they threaten government punishment of private citizens (e.g., by withdrawal of existing funding) purely for speech that the government does not like.

So I ask the anonymous Senate aide who drafted this provision, and the anonymous lobbyist(s) who influenced him or her, have they no shame? 

Finally, I have yet to see coverage of the Selker and Wood article in the mainstream media.  I hope they will eventually conclude that this attempt to co-opt clinical science and mock the 1st amendment is actually news and comment worthy. 

Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development

In "Academic Freedom and ED EHR's Down Under: An Update" I wrote about the disputed essay on electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney.

The essay was entitled "A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?"

I am happy to report that an updated version of the essay, version 5, is now available from Dr. Patrick's university web site at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 . It can be downloaded from the icon at Item 6.

This is a welcome development.

The essay is now labeled as an Op-Ed (Opinion Editorial).

-- SS

Academic Freedom and ED EHR's Down Under: An Update

At the post "Academic Freedom Curtailed?" I wrote:

The essay on Emergency Department electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney, that I referenced in my posts "The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" and "NSW Nightmare and Overuse of Computers" appears to have been censored. This apparently occurred at the level of the the government.

Professor Patrick has updated his web page that formerly contained a link to his essay on problems with EHR's in that state's EDs.

He advises:

... This document has been temporarily withdrawn by the university following a complaint from NSWHealth. I think the University has acted appropriately by investigating the complaint and I do not yet consider it an act of censorship. I am working through the issues with the University and expect that the essay will be re-published.

I would like to thank all the people who have written to me to offer support and I would encourage you to write to me if you are interested in the matter so that i can demonstrate to the university the importance of this issue to both the Australian and international communities. I do not wish for people to write to anyone else but me. I have no wish to run a public campaign and I am not available for statements to the press about this particular matter. This matter has brought to light many interesting and illuminating things that i will be happy to share in the next version of the Critical Essay.

Jon Patrick 27th October 2009 0930 Eastern Australian Summer time

He then follows up with this:

Update on the withdrawal of "Essay No.6"

It is now two weeks since the original essay was withdrawn. In that time I have been able to establish confidently that NSWHealth phoned my Head of Department and asked him to remove the article without giving a specific complaint. He refused. Subsequently a person from another faculty took up the cause and succeeded in persuading an appropriate person to order withdrawal of the essay. To this time i have not received a specific complaint let alone a written complaint. The Univeristy's Office of General Counsel has studied the essay at my request through my Dean, and found that it is "consistent with the University's Public Comment Policy". I am awaiting further investigations by the University.

Subsequently I have received many messages of support from around the world, and importantly much more information to be included in the essay. I am preparing a much enhanced version.

5th November 2009 1150 Eastern Australian Summer time

I sincerely hope this matter will be resolved in favor of dissemination of the enhanced and updated piece. I think it contains information that is quite valuable to a worldwide audience of clinicians, IT vendors and patients.

I also note that those who aim to suppress a document such as this in the age of informational computing, one product of which is the Internet, should be confined to using only the Commodore PET due to their technological and sociological ineptitude:

State-of-the-art computing for the would-be Health IT article police

-- SS

Addendum

Nov. 10, 2009, evening EST:

The essay in version 5 is once again available as Item 6 at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 .

-- SS

Academic Freedom Curtailed: Censorship Down Under On EHR's for the Emergency Department?

In a stunning development:

The essay on Emergency Department electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney, that I referenced in my posts "The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" and "NSW Nightmare and Overuse of Computers" appears to have been censored. This apparently occurred at the level of the the government.

The essay was available as item 6 at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 . Attempts to download now provide a message "This document is not currently available." I do not know if the vendor was involved.

(A copy of vers. 3 of Professor Patrick's report is still available here in PDF; it was a work in progress when it was pulled.) [Oct. 24 - see addendum below - ed.]

This appears to be an overt example of suppression of academic freedom that I believe should receive widespread attention, most especially if there is retaliation of any kind against the professor.

I also believe censorship of a document such as this could escalate to a human rights issue regarding what appears to be deliberate censorship of critical information about IT systems that could possibly be putting large numbers of patients at risk. Imagine if this was a report about potentially defective nuclear reactor control systems or containment processes at biological hazards research sites.

I believe addressing the issues raised in the report would have been a far more responsible approach than censorship.

-- SS

Addendum 10/24: The author of the paper asked me to remove it from my server as well. It is currently unavailable. This situation is in flux and hopefully will be resolved soon. Hopefully, the issues in the report will be addressed.

A Blogger That Dares Not Speak His University's Name

Dr Douglas Bremner is a Professor of Psychiatry and Radiology at Emory University, and Director of the University's Clinical Neuroscience Research Unit. He has also written a book critical of the pharmaceutical industry (Before You Take That Pill), and writes a blog (also called Before You Take That Pill) that is also skeptical about certain aspects of current psychiatric dogma. Inside Higher Education reported that Emory University can apparently no longer bear to have its name mentioned in Dr Bremner's blog:

Emory University has been accused repeatedly over the last year of looking the other way while one of its prominent physicians built extremely close ties to the pharmaceutical industry and -- critics charge -- failed to adequately report those ties as required by university and federal regulations.

But what if you are an Emory professor who happens to differ with the pharmaceutical industry? Then, it appears, Emory watches you closely -- and if you are a blogger, the university can tell you that you must remove the Emory name from your Web site. That's why a recent post on the J. Douglas Bremner's blog Before You Take That Pill is called 'I Am Removing the Name of My University From This Blog.'

In the post, he notes that he was recently ordered to remove the Emory name both by the interim chair of psychiatry and behavioral sciences, and by the medical school's executive associate dean for faculty affairs. In the letters, which he provided to Inside Higher Ed, they tell Bremner to remove Emory's name, logo and letterhead from his blog because none of them can be used for 'non-Emory business.' He was also told to report on when he had removed Emory from his blog.

The letters cite complaints that the university received about a blog post Bremner made in January in which he criticized the eviction of a man with bipolar disorder who was being forced out of his apartment for smoking. Bremner made his point in the form of a mock letter 'To Whom It May Concern' giving his blessing for the man to continue to smoke. According to Bremner's Emory superiors, complaints they received suggested that he was making 'clinical recommendations for a patient you do not know and have never examined,' and these postings made them feel the need to tell him to stop using the Emory name.

And even more concerning:

Sarah E. Goodwin, director of media relations for Emory Health Sciences, said that Emory's objection to the use of its name in non-official places was 'across the board' and not related to the content of Bremner's blog. When told about other blogs or Web sites where Emory professors' university affiliation was noted on non-Emory business, she said she didn't know why that was the case but insisted that the ban was 'across the board.'

She noted that Bremner has been 'blogging for some period of time,' and that 'if you read it over a long period of time, you can see comments he makes that may be of concern.' She declined to identify those comments.

So there you have it. It appears that faculty members, even senior faculty at Emory who make comments "that may be of concern" to an Assistant Vice President for Health Sciences, and Director, Media Relations, are not supposed to identify themselves as Emory faculty. This is the sort of policy one might expect from certain corporations. But Emory is a university. It proclaims it

is an inquiry-driven, ethically engaged and diverse community whose members work collaboratively for positive transformation in the world through courageous leadership in teaching, research, scholarship, health care and social action.

It proclaims its strategic plan is entitled:

Where Courageous Inquiry Leads

We can see where courageous inquiry leads at Emory. It leads to University executives attempting to censor faculty blogs when they included "concerning" remarks. As Inside Higher Education noted, Emory executives have not attempted to have other faculty bloggers remove references to the University, or to the bloggers' faculty status from their writing. Presumably, those bloggers were more politically correct.

We have often written about the suppression of medical research that is now a plague upon medicine, and the most dire threat to the evidence-based medicine approach. The research most likely to be suppressed is that which offends vested interests, particularly vested interests in selling particular health care goods or services. On the other hand, the Foundation for Individual Rights in Education (FIRE) for years has been fighting to uphold free speech and academic freedom on campus, but has mostly dealt with threats to politically or socially unpopular speech.

This case seems to blend these these different kinds of threats to free speech and academic freedom. It once again shows how elite universities increasingly are run like for-profit corporations, putting the prerogatives of managers ahead of the individual rights of faculty and students, and putting the mission of the university, to discover and disseminate the truth in the spirit of free enquiry, in the trash.

Dr Bremner's own comments in his blog are here. He concluded that Emory managers were "thinking more like a corporation than a university, where the free exchange of ideas, regardless of the perceived value or political correctness of those ideas, is held to the highest standard."

See also comments by Prof Margaret Soltan in the University Diaries.

ADDENDUM (15 July, 2009) - Emory has backed down, and will once again allow Dr Bremner to identify himself as a faculty member. See this post by Dr Bremner, and this post on The Torch (the FIRE blog).

The Political Incorrectness of Discussing Conflicts of Interest in Medical Academia

From today's Boston Globe,

Tufts University has withdrawn an invitation for a top aide to US Senator Charles E. Grassley to give the keynote speech at a conference on conflicts of interest in medicine and research, leading one conference organizer to pull out and question the university's commitment to academic freedom.

The University-wide Committee on Ethics rescinded the invitation on March 13, according to e-mails obtained by the Globe. The messages said top Tufts officials refused to allow other administrators to be panelists at the meeting if Grassley's aide spoke, saying it was inappropriate to do so while Grassley is investigating ties between a Tufts professor and the drug industry.

The senator, a Republican from Iowa, sent a letter on Feb. 17 to the president of Tufts, Lawrence S. Bacow, requesting detailed information on the relationship between a 'Dr. Boucher' and the pharmaceutical industry, including the amount and dates of all industry payments between January 2006 and December 2008. Dr. Helen Boucher is an infectious diseases specialist at the Tufts medical school.

Spokeswoman Christine Fennelly first said in an e-mail that when Grassley declined the invitation, 'it was decided to refocus the symposium on a smaller scale, where the panelists would be faculty from Tufts University and affiliated faculty from Tufts Medical Center.'

Later, when told that Krimsky's e-mails explicitly said the speaking offer was rescinded, she said the invitation to Grassley's aide had been withdrawn. 'Indeed . . . the administration felt it prudent to not engage someone from the Senator's office while we respond to the Senator's inquiry,' she wrote.

One only has to browse the FIRE (Foundation for Individual Rights in Education) web-site to see the sad state of free speech and academic freedom in American universities. Most of the cases they discuss seem to involve barriers to presenting politically incorrect viewpoints on campus. FIRE has presented several cases involving dis-invitation of speakers with such views.

On the other hand, on Health Care Renewal we have discussed our share of cases involving free speech and academic freedom in academic medicine. Most of these cases seem to involve barriers to presenting research results that turn out unfavorable to vested financial interests, particularly interests served by the promotion of particular health care products, like drugs or devices, or services.

This case appears to be something of a hybrid. Like a number of cases discussed on the FIRE web-site, it involves the dis-invitation of a campus speaker whose viewpoint might not fit with that of the powers that be on campus. However, instead of causing offense because of his political positions, Mr Thacker seemed to cause offense because he has been involved in investigating conflicts of interest affecting medical academics. Thus, it seems that discussing such conflicts of interest has become politically incorrect. This seems to be a fairly blatant instantiation of the anechoic effect.

See also comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

ADDENDUM (31 March, 2009) - also see comments on the Effect Measure Blog.

Drug Company Claims "Disparagement" by Proxy

We have occasionally posted on what has come to be called the "Nancy Olivieri case," one of the most important cases of attempted suppression of clinical research from the 1990s. Briefly, Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri after she revealed preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link here for report) (See this post.) This case has been reprised via several posts by Dr Aubrey Blumsohn on the [Anti-] Scientific Misconduct Blog here, here and here.

This month, the Canadian Association of University Teachers (CAUT) published a news item about a bizarre sequel to this case. Here is the background,

Dr. Olivieri [tried] to enforce an agreement she entered into with Apotex in November of 2004 in settlement of defamation claims by both parties.

On Friday, November 28, 2008, after a lengthy course of litigation, Justice George Strathy of the Ontario Superior Court of Justice ordered that Apotex must perform all the terms of the settlement agreement. Those terms include the payment to Dr. Olivieri by Apotex of $800,000, a figure first made public by Justice Strathy in his order.

The settlement agreement contained a term that Dr. Olivieri would not subsequently 'disparage' Apotex or the drug deferiprone.

Now here is the amazing part,

Most recently, Apotex has made its claims of “disparagement” against Dr. Olivieri in a Superior Court action commenced on November 4, 2008. Justice Strathy’s order does not affect the new Apotex action. In its action Apotex could claim from Dr. Olivieri the full amount of $800,000 required to be paid to her under the settlement agreement.

In its statement of claim Apotex takes a very broad view of what constitutes actionable 'disparagement' by Dr. Olivieri. Apotex claims that actionable 'disparagement' includes situations in which Dr. Olivieri is said to have 'acquiesced or consented' to alleged 'disparagement' by others. Instances of 'disparagement' alleged by Apotex include:

* A Wikipedia internet description of Dr. Olivieri, written by a person other than Dr. Olivieri;
* An opinion column referring to Dr. Olivieri in The Globe and Mail written by a Globe columnist, not Dr. Olivieri, which does not contain any statement about Apotex attributed to Dr. Olivieri;
* A motion picture company’s description of a potential movie about Dr. Olivieri;
* A complaint to a newspaper by Dr. Olivieri that statements made in an article referring to her were incorrect.

In its claim Apotex also makes many allegations of 'disparagement' that appear to be based solely on Dr. Olivieri’s participation or attendance at conferences on the relationship between universities and the pharmaceutical industry at large, academic freedom, scientific research and conflict of interest.

So according to Apotex, physicians and medical academics are liable for what is said or written about them by third parties, even if the physicians and academics had nothing to do with what the third parties wrote or said.

So, by the way, by extension from the arguments made by Apotex, by writing this blog post, I have somehow caused Dr Olivieri to further disparage Apotex.

This is egregious nonsense. The filing of the lawsuit by Apotex, which Dr Olivieri will presumably have to go to considerable expense to defend, is a threat to the academic freedom and free speech of all in academia, but particularly to medical academics, and by extension, also is a threat to the free speech of all physicians. This sort of litigation further chills the atmosphere in free speech in health care, a sphere in which criticism of powerful organizations and their powerful leaders is already scarce and threatened.

This should be a wake up call for those physicians and medical academics who maintain a consistently rosy view who persistently believe that those nice people at the top of pharmaceutical, biotechnology, and medical device companies are always on the side of righteousness and good.

Hat tip to the Center for Science in the Public Interest's Integrity in Science Watch here.

See additional comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

Silverglate on How Corporate Academic Leaders Try to Control the Message

In the US, and most countries, academic medicine, including medical schools and teaching hospitals, are situated within larger universities. The leaders of academic medicine report to university presidents, who in turn report to university boards, who are ultimately responsible for upholding the universities' mission.

Perhaps one reason that universities, and their academic medical components seem to have worsening difficulties upholding their missions is that their top leaders increasingly are people to whom the academic mission may be a foreign concept. For example, we recently discussed how the board of trustees of one prominent university with a prominent medical school has been taken over by leaders from the finance sector, the same sector which brought us all the global financial collapse.

In an article in the Boston Phoenix, civil liberties expert Harvey Silverglate discussed some other aspects of academic integrity failures, that is, how academic institutions now operate counter to their fundamental mission.

Harvard is accustomed to turning other universities green with envy. So it comes as no surprise that its alumni publication, Harvard magazine, which is largely financially self-sufficient and editorially independent of the university, has become a model to which other universities aspire. But rather than take pride in the bi-monthly’s stellar 108-year-old reputation, university administrators effectively declared war on Harvard magazine earlier this year when they brought out an in-house competitor. The new rag, The Yard — which Harvard sends four times a year to alumni, big donors, and parents of students — strikes a decidedly more self-flattering tone than its independent counterpart.

Why the change, and why now? In a word, the answer is: fundraising. As the Wall Street Journal reported in June, 'fund-raisers determined that Harvard magazine was no longer serving their best interests.'

In an era when corporations and politicians pay public-relations consultants big bucks to control the 'message,' one would hope that universities, devoted to the 'free marketplace of ideas,' would resist the trend. Yet in recent years, Harvard, like almost all universities, has been eager to limit how much the public in general, and alumni in particular, learn about what’s really happening on campus. This is especially true as many universities continue to sacrifice traditional academic values — free speech, academic freedom, and fair disciplinary proceedings — in favor of censorship and closed administrative proceedings that function as kangaroo courts, in a misguided attempt to avoid controversies that might gain public attention.

The reality is that alumni fund a major portion of private universities’ budgets, and even public institutions are increasingly dependent on former students to supplement stagnant or decreasing state education budgets.

Growing increasingly anxious, officials at public universities turned toward upbeat alumni mags to buoy fundraising efforts. Over the past 15 years, schools that had never previously published alumni mags began cranking out thousands of the things....

The image-above-all mentality is part of a lamentable trend 'Freedom Watch' has long identified as 'the corporatization of higher education.' Increasingly, university presidents operate more like CEOs than academic leaders: they emphasize the bottom line, large endowments, U.S. News and World Report rankings, and highly visible campus construction (and donor-naming) projects, while they neglect or marginalize academic excellence, intellectual inquiry, academic freedom, and students’ rights.

A sampling of local [to Boston] alumni glossies reveals a near-universal practice of praising the university, even if it means demeaning the intelligence of alums.

As Alan Charles Kors and I pointed out in our 1998 book, The Shadow University: The Betrayal of Liberty on America’s Campuses, academic freedom is being sacrificed so that academic administrators can play-act as empire-builders and careerists rather than serve as educators. The typical modern college president’s goal is to have no controversy, no trouble 'on my watch,' we wrote.

This article suggests several important points.

First, there is a growing realization that academia's mission is being increasingly subverted as the leadership of academic organizations, including, in particular, academic medicine, increasingly resembles corporate leadership. (We, of course, have repeatedly discussed the prominent movement in health policy in the 1980s that advocated breaking the "medical guild" while handing power over health care to bureaucrats and managers.)

Second, there is a growing realization that academic leaders who ape their corporate peers have a penchant for propaganda promoting their interests, and for suppressing discussion of their faults. Clearly these are causes of the anechoic effect. Never mind that controlling speech and communication in this manner is antithetical to the fundamental academic mission to discover and disseminate the truth in the spirit of free enquiry.

A practical lesson for those interested in what is going wrong with academic medicine. Do not expect to find much out about what is going wrong from academic medical institutions themselves, and particularly from the publications and media they sponsor. Just because academic medical institutions are supposed to promote discussion of important issues in medicine, health, and health policy, do not expect them to allow discussion of issues that reflect baldly on their fearless leaders.

But Silverglate warned administrators intent on controlling the message:

For administrators to think that they can mold alumni opinion by monopolizing the universities’ messages sent to grads ignores the growing realities of our increasingly sophisticated and informed electronic-media-saturated culture.

Now that no-nonsense alumni are seeing through the smoke and mirrors, cutting off donations and asserting control of alumni associations and boards of trustees, colleges may have no choice but to pay attention to the rising chorus of voices saying 'enough!'

We hope that Health Care Renewal and some of the blogs to which we link are part of an "increasingly sophisticated and informed electronic media" which will help people see through the "smoke and mirrors," and encourage them to say "enough."

Thoughts on Charles Nemeroff's Not So Excellent Adventure

The saga of Dr Charles Nemeroff was most recently discussed on Health Care Renewal here. We had first posted about his failure to disclose relevant conflicts of interest relating an article he wrote for a journal he also edited here. Other posts about Nemeroff's questionable behavior are here, here. Nemeroff has also starred in numerous posts on the Clinical Psychology and Psychiatry Blog, amongst others.

Now the tale of how Nemeroff raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while he ran a US government funded project meant to evaluate some of the products of his commercial sponsors, has splashed across major newspapers. There has been a lot of good discussion about the case in the blogsphere. (We await, of course, discussion in scholarly medical and health care journals, if it ever appears.)

I did think it was worth weighing in again just to underline some important points about this affair.

It has become common for academic leaders to earn more hawking commercial products than from teaching, research, or patient care. The database unearthed by Senator Grassley just of the speaking fees earned by Dr Nemeroff giving speeches promoting GlaxoSmithKline products is breath-taking. As noted by the anonymous blogger on the Clinical Psychology and Psychiatry Blog, Nemeroff was earning on average more than $20K a month from GlaxoSmithKline alone. That was from only one company. As that blogger also noted, Nemeroff at one point was a consultant for 18 companies, if I counted right, and gave paid talks for 4. Here is the actual relevant part of the disclosure statement.

[Nemeroff] has been a consultant to Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers Squibb, Corcept Therapeutics, Cypress Bioscience, Cyberonics, Eli Lilly and Co, Entrepreneur’s Fund, Forest Laboratories, Inc, GlaxoSmithKline, i3 DLN, Janssen Pharmaceutica, Lundbeck, Otsuka America Pharmaceutical, Inc, Pfizer Pharmaceuticals, Quintiles Transnational, UCB Pharma, and Wyeth-Ayerst Laboratories; has been on the speakers bureau for Abbott Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, and Pfizer Pharmaceuticals;

At most medical schools, bringing in money is more important than academic integrity, or anything else. We have previously posted about how one medical school leader explained that faculty who are "taxpayers," that is, bringers of money, are more valued than all others.

The case of Nemeroff shows how big-time taxpayers are now above the law at medical schools. As Dr Howard Brody explained it on the Hooked: Ethics, Medicine and Pharma Blog

[Nemeroff] sent a confidential letter to the dean of the medical school at Emory in May 2000, listing the dozen corporate advisory boards in which he sat. He then ticked off the grants and endowments that those firms had paid to the Department of Psychiatry at Emory, and added, 'Part of the rationale for [the companies'] funding our faculty in such a manner would be my service on those boards.' Translation--you mess with my cozy relationships with these companies, and the industry gravy train to Emory dries up. The threat is only slightly veiled, that should Emory decide to take any serious action against Nemeroff for his unreported conflicts of interest, he could easily jump ship to a more permissive med school, taking a lot of his captive research faculty and all of his industry funding with him.

Lying is an acceptable way to maintain an academic medical leadership position. Senator Grassley's letter to Emory documented this instance:

On several occasions during the life of this grant, it appears that Dr. Nemeroff
failed to report to Emory that he was participating actively on the speaker’s bureau for GSK. For instance, in an email regarding his outside activities dated October 1, 2003, Dr. Nemeroff wrote:
'…I have to dig up the agreement and send it to you, GSK no standing
contract, I chair their ad board 2-3 times per year and I am paid per board
meeting at a standard rate of $5K per weekend.'
However, and based upon information in our possession, in 2003 GSK
paid Dr. Nemeroff about $119,000 in speaking fees and expenses.

$15,000 does not remotely equal $119,000. Stating he was paid the former when he was paid the latter goes beyond "misspeaking."

Bullying helps too. As Dr Brody put it,

Nemeroff is pleased to bear the nickname 'Boss of Bosses.' He has a reputation for wielding tremendous power in psychiatry, especially taking advantage of his leverage with the big drug firms, and is ruthless in attacking those whom he doesn't like or who threaten him. One such event is described in some detail in HOOKED, the hiring and then subsequent firing of David Healy as head of a psychiatric research institute at the University of Toronto, due to Healy saying bad things about Prozac, whose manufacturer, Eli Lilly, was at the time considering a major grant to Toronto. Healy cheerfully sued Toronto and won, meaning that all the correspondence related to the firing is now in the public domain. In HOOKED I focused on Toronto's spineless behavior, but it is also interesting to note that almost certainly, Nemeroff was in the background pulling all the strings that led to Healy's dismissal.

Not only was this a case of bullying, of course, but it was also a case of the trampling of academic freedom, in this case, apparently to support the continuing relationship between pharmaceutical companies, "key opinion leaders," and medical schools, so profitable to these parties, but so detrimental to the integrity of academic medicine and of the clinical research data base.

The case of Charles Nemeroff's not so excellent adventure illustrates the sorry current state of the leadership of academic medicine. As Dr Brody put it,

In today's world, a medical school like Emory looks at all the pluses and minuses of having a guy like Nemeroff as a powerful chair, and decides that the pluses outweigh the minuses. His publication record is stellar (mostly ghostwritten of course), he brings in huge research grants, and people in his specialty all over the world want to kiss the hem of his garments. What has to change, in the regulation and the culture of the academic medical center, so that it becomes a no-brainer that having a guy like this on your faculty is a net loser?

Without such change, the public will fairly start to judge academic medicine's integrity as only slightly better than that of the garbage hauling industry, and that may be too insulting to the garbage hauling industry. It is sad beyond words that the current leadership of these once proud institutions have lead them to this pass, just for a few dollars more.

ADDENDUM (8 October, 2008) - See also comments by Dr Daniel Carlat on the Carlat Psychiatry blog here and here, and by Alison Bass on the Alison Bass blog here.

Brown University Student Journalists Dare to Report on Paxil/ Seroxat, Study 329 and GSK

We have published a few posts about the controversy about the clinical research supporting the use of paroxetine (Paxil, Seroxat in the UK, made by GlaxoSmithKline) in depression (here, here, here, and here.) This controversy includes allegations that clinical research funded by GSK was manipulated, and that the company's marketing for the drug was unsupported by clinical evidence. GSK settled a case alleging fraud in the marketing of Paxil by then NY Attorney General Eliot Spitzer in 2004. A recent article provided arguments and evidence that Study 329, a clinical trial of paroxetine for adolescents, was manipulated , allegedly at least with the acquiescence of Brown University Psychiatry Chair Dr Martin Keller. [Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008; 20: 73-81. Link here.] A book entirely devoted to this controversy, Side Effects by Alison Bass, who started reporting on the case in 1999 for the Boston Globe, was just published.

I am a still proud alumnus of Brown University (undergraduate and medical). I was a full-time faculty member at the University from 1994-2004, and am still a clinical faculty member. Despite Dr Keller's and the University's central role in the case, at least as alleged by Ms Bass and by Jureidini et al, there has only been silence about the case here in Rhode Island.

That just changed. Intrepid reporters from the Brown Daily Herald published two stories on the GSK/ Paxil/ Keller controversy. Both included some important original reporting, as well as providing clear summaries of the issues at hand.

The first article dealt mainly with Keller's alleged conflicts of interest. This article provided confirmation that Senator Charles Grassley (R-Iowa) and the US Senate Finance Committee is, in fact, investigating Dr Keller and Brown University in connection with the controversy. It also included other original reporting, including an acknowledgement from GlaxoSmithKline Director of US Media Relationships Sarah Alspach that the company had provided the committee with full information about the compensation it gave Dr Keller.

The second provided a quite clear explanation of the allegations about the manipulation of Study 329. This article also included results of an interview with Dr Jon Jureidini, the author of an article that dissected study 329, and suggested that it had been manipulated to enhance the apparent benefits of paroxetine, and diminish its apparent risks. The reporters noted that Jureidini was "confident that data in Study 329 were deliberately misrepresented." They were also able to obtain an internal GSK document that acknowledged that study 329 did not prove the efficacy of the drug.

The BDH reporters, Chaz Firestone and Chaz Kelsh, in my opinion, did a fine job, clearly explaining the issues, and digging out some new facts on the case.

Nonetheless, the BDH reporters were not able to get Dr Keller to talk to them, despite several attempts. They were not able to get anyone in the University administration to discuss any substantive aspects of the case. The highest ranking University official who would talk to them was Provost David Kertzer. He asserted that the University "can't discuss particular cases of possible claims of wrongdoing and what we do about them."

In my opinion, and as I said to the reporters, one of the most distressing aspects of this case is the refusal of Dr Keller or anyone in the University to deal with the content of the case. Very serious allegations have been made. If they can be refuted, they should be. If not, stonewalling only increases the impression that the University administration has something to hide.

Furthermore, the case raises important issues about science and clinical medicine. Universities are supposed to be where people can conduct free enquiry. There seems to be no free enquiry at Brown into the issues raised by this case. University administrators should be encouraging free enquiry. Here, they seem to be doing their best to avoid, if not stifle it.

Today, the BDH published its own editorial on the case, suggesting that Dr Keller's "actions directly affect the integrity of the University." If so, the University community should, at the very least, be discussing these actions, how they affect this integrity, and what ought to be done about it. Unfortunately, I am not optimistic that there will be an open discussion of these issues, even after the brave publication of these articles. The University administration seems to have some reason they want to clamp a lid on this case, and I am afraid they will continue to do so. The medical school faculty, lacking tenure and remembering what happened to previous dissenters like Dr David Kern, are likely to be too scared to push that lid away. Woe unto Brown.

See also comments on the Alison Bass Blog, PharmaGossip, and Pharmalot.

ADDENDUM (29 September, 2008) - See also this post on the Alison Bass blog, with links to some of the original documents relevant to study 329.

More Watchdogs Who Did Not Bark: the UCU Ignores Dr Blumsohn

We posted first here in 2005, then here, here, here, here, here, here, here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Some of the analyses done by P&G seemed biased in favor of the drug. Despite repeated attempts, P&G would not give Blumsohn access to the raw data of the project. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him. As far as I can tell, he eventually lost his academic position at the university, and has not been rehired. Also as far as I can tell, these events have never been the subject of open hearings at the university, or of investigations by any outside body.

This week, Dr Blumsohn, who now has quite a following (currently #53 on the Healthcare100 hit parade) for his Scientific Misconduct Blog, posted about the lack of response to a letter he wrote in 2005 to the UK Association of University Teachers (AUT), which later merged with another organization to form the University and Colleges Union (UCU). He also noted that the UCU has failed to respond for an even longer time to the case of a faculty member at another university who was dismissed apparently after her research (about the politically controversial topic of the characteristics of people seeking asylum in the UK) was found to be "incompatible" with that university. It is unclear why the UCU has ignored two cases in which universities sacrificed their faculty members' academic freedom to avoid offending the powerful. It is disgraceful that the case of Dr Blumsohn has never been publicly revisited at the University of Sheffield, and never been investigated by any academic or medical organization.

What befell Dr Blumsohn has been a continuing motivation for us to at Health Care Renewal. Sadly, it is hardly the only case of medical and health care academics who suffered because because what they said or wrote, no matter how true, offended those in power. Credible medical and clinical science will not long survive when scientists cannot draw conclusions that threaten vested interests. Academic medicine's credibility will not long survive in the absence of academic freedom.