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. 

Post Title → No Free Speech for Comparative Effectiveness Researchers?

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).

Post Title → A Blogger That Dares Not Speak His University's Name

The "Investment Bankers" Strike Back: A Dissident is Thrown Off the Dartmouth Board

We have posted frequently on the governance and leadership of academic medical organizations. While one would think that health care organizations, and especially academic health care organizations ought to be held to a particularly high standard of governance, we have noted how their governance is often unrepresentative of key constituencies, opaque, unaccountable, unsupportive of the academic and health care mission, and not subject to codes of ethics. How the governance of organizations with such exemplary missions and sterling reputations got this way has been unclear.

We have often come back to the example of Dartmouth College, of which Dartmouth Medical School is a significant component. We most recently summarized here an ongoing dispute about the extent that the institution's board of trustees ought to represent the alumni at large, or instead, ought to be a self-elected body not clearly accountable to anyone else. When we first addressed the dispute, we noted that the self-elected, or "charter" members of the board were mostly leaders in finance, and when they succeeded increasing the proportion of self-elected members, the additions were again, mainly from finance.

The latest development at Dartmouth is that the board, whose majority is now self-elected, is going to boot off one of the few members who was elected by the alumni at large after being nominated by petition of alumni. As described in an editorial in the college newspaper, The Dartmouth,

We were dismayed to learn of the Board of Trustees’ decision not to reelect Trustee Todd Zywicki ‘88 for a second term ('Board votes not to reelect Zywicki ‘88,' April 7). Even in the wake of Zywicki’s open letter to the Dartmouth community on Tuesday ('Zywicki ‘88 criticizes Board in open letter,' April 15), the Board has yet to provide the Dartmouth community with a sufficient explanation for the removal.

Since 1990, when the power to reelect alumni trustees was transferred from alumni to the Board itself, reappointment to the Board for a second term has generally been routine; Zywicki is the first trustee in recent history to be denied reelection.

Zywicki said in his letter that comments he made during an address at the John William Pope Center in October 2007 'might have been' one of the reasons behind the Board’s decision. In the address, Zywicki made a series of controversial and inflammatory statements, including calling former College President James Freedman 'truly evil.'

Assuming that no egregious act remains undisclosed (and there has been no indication that this is the case), Zywicki’s removal disregards the will of the alumni who put him on the Board, and contradicts the democratic manner in which alumni elect trustees.

Dissenting opinions are essential to the operation of any governing body. While Zywicki may have behaved unprofessionally, the public reprimand issued by the Board was sufficient punishment. It is one thing to reprimand a trustee for making statements against the College in a public forum, but to remove dissenting opinions from the boardroom is to undermine the will of the alumni who voted in support of those very views.

Further news coverage in The Dartmouth suggested a flawed process was used to get rid of Zywicki,

Trustee T.J. Rodgers '70, who like Zywicki was nominated to be a candidate for the Board via petition and was successfully reelected at the April meeting, compared the reelection process to a 'witch-hunt trial' and said it was 'an affront to due process' in an e-mail to The Dartmouth.

'[Zywicki] was ejected by a secret vote — he was not allowed to know the vote count or even the reasons behind his ejection,' Rodgers said in the e-mail.

Rodgers added that he believes the decision not to reelect Zywicki was 'an embarrassment for the Board.'

'The effect of Todd’s ejection has been to warn me and any other trustee likely to speak his or her own mind to watch our step,' he said in the e-mail.

Finally, Mr Rogers wrote his own commentary in The Dartmouth,

'Hang one, warn a thousand' says the ancient Chinese proverb. In its April meeting, the Dartmouth Board of Trustees hanged Todd Zywicki '88, thus warning the petition trustees — and any others tempted to express independent views — not to cross the party line. The Board’s action was coldly deliberate. The legal machinery by which it was achieved took two years to construct.

Every 20 years or so, when a majority of the alumni body decides that the College is ignoring a critical problem, it elects petition trustees to promote change. That tradition, a healthy method of governance that sets Dartmouth apart, goes back to 1891, when alumni were formally granted one-half of Dartmouth’s Board seats in return for financing the College.

[After Rogers' election,] Subsequently, the alumni elected three more petition trustees with views similar to mine: Peter Robinson ‘79, Todd Zywicki ‘88 and Stephen Smith ‘88. It was no accident that each of them was a university professor or scholar. The Board Majority, predominantly composed of investment bankers, could have benefitted greatly from the new trustees’ education-first viewpoint, but instead, we were treated as if we were attacking the College. We were actually called a 'radical cabal' trying to 'hijack' the College by the Board member whose seat I had taken. The petition trustees had successfully overcome the penny-ante counterattacks, such as denying us the ability to mail our petitions to alumni to request signatures, and raising the required number of petition signatures, so it came time for the Board Majority to fix the petition trustee 'problem' permanently.

First, the Majority Board members simply declared the right to double their number from eight to 16 without adding an equivalent number of alumni trustees, despite an Association of Alumni poll of 4,000 alumni, who responded in favor of alumni trustee parity, 92 percent to eight percent. Then, the Majority threw its weight and College funds into a campaign to remove the Association leaders who had sued the College for breaking the 1891 Agreement.

In the boardroom, the Majority rewrote the 50 year-old Trustee Oath into an oath of loyalty, which was designed, in part, to limit trustees’ ability to express dissenting viewpoints without the direct threat of being ejected from the Board. And finally — fatally for Todd Zywicki — the Majority installed a formal review process that judged trustees against the new oath on a line-by-line basis.

On the day of his trial, Zywicki was asked if he wanted to make a statement. He apologized again for his Pope Center speech and exited. In order to maintain the confidentiality of board proceedings, I cannot give details. However, I can say from personal knowledge that many of the statements made in that meeting about Todd Zywicki were factually incorrect, but Todd was not there to respond. In my opinion, all of the issues, including his speech, did not rise to the level of negating the votes of the alumni who elected Todd. Despite my objection, the vote — for the only time in my five years on the Board — was secret.

Todd Zywicki’s greatest achievement as a Dartmouth trustee may well be having the personal courage to force the Board Majority to take responsibility for a political lynching.

Since I started writing about the governance of health care organizations, I used the example of Dartmouth (again, really a university with a medical school as a major component) as an example of governance that was more representative and accountable than that of many other health care organizations. Most universities that contain medical schools, for example, do not allow alumni to vote on the membership of more than a few board seats, and most only allow them to vote for alumni candidates hand-picked by the administration, not nominated by alumni petitions. However, since I started writing about Dartmouth, it seems that the self-elected majority of its board has done its best to make the board less representative and less accountable. Furthermore, it seems that some of the board's self-elected members regard anyone who disagrees with them as an enemy of the institution. Thus, their attitude seems to be: "l'universite c'est moi."

However, the duties of boards of trustees include the duty to uphold the institution's mission, not the board members' personal whims.

When I first started writing about these issues, I was surprised to find that the majority of the Dartmouth's boards self-elected, that is, "charter" trustees were from the finance sector. Now, having seen poor, sometimes arrogant, greedy, or even corrupt leadership of that sector bring down the world economy, I ask again whether people brought up in that culture ought to be dominant among the leadership of higher education?

Post Title → The "Investment Bankers" Strike Back: A Dissident is Thrown Off the Dartmouth Board

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.

Post Title → The Political Incorrectness of Discussing Conflicts of Interest in Medical Academia

An Inaugural Moment to Improve Health Care

Many phrases of US President Barack Obama's inaugural address seemed to speak to issues often discussed on Health Care Renewal. See the quotes below, taken in order from the transcript of the speech, and I hope not too much out of context.

Our economy is badly weakened, a consequence of greed and irresponsibility on the part of some, but also our collective failure to make hard choices and prepare the nation for a new age.

On this day, we come to proclaim an end to the petty grievances and false promises, the recriminations and worn out dogmas, that for far too long have strangled our politics.

We remain a young nation, but in the words of Scripture, the time has come to set aside childish things.

But our time of standing pat, of protecting narrow interests and putting off unpleasant decisions — that time has surely passed.

We will restore science to its rightful place, and wield technology's wonders to raise health care's quality and lower its cost.

What the cynics fail to understand is that the ground has shifted beneath them — that the stale political arguments that have consumed us for so long no longer apply.

Those of us who manage the public's dollars will be held to account — to spend wisely, reform bad habits, and do our business in the light of day — because only then can we restore the vital trust between a people and their government.

Nor is the question before us whether the market is a force for good or ill. Its power to generate wealth and expand freedom is unmatched, but this crisis has reminded us that without a watchful eye, the market can spin out of control — and that a nation cannot prosper long when it favors only the prosperous.

To those who cling to power through corruption and deceit and the silencing of dissent, know that you are on the wrong side of history; but that we will extend a hand if you are willing to unclench your fist.

Of course, most of these remarks were not specifically about health care.

However, on Health Care Renewal we have documented multiple examples of "greed and irresponsibility" on the part of some health care leaders, and certainly our collective failure as medical professionals "to make hard choices."

Health care has seen far too many "false promises," often made to further vested interests.

The arguments too often made in support of the powers that be have been "childish."

"Narrow interests," often serving the wealth of a few privileged people, have been all too evident.

We certainly hope we can responsibly use "technology's wonders," but not naively or uncritically. We need to make health care decisions according to the best scientific evidence, critically reviewed, in conjunction with knowledge of biology, and in accord with individual patient's values and preferences, to improve health care. We need to better use information technology, but be clear-eyed about its current limitations and potential adverse effects.

We have also seen "stale political arguments" often used again to support vested interests.

Hopefully, in both the public and the private sectors of health care more leaders will "spend wisely, reform bad habits, and do ... business in the light of day."

There have not been enough "watchful eyes" on the health care "market," and hence we have repeatedly documented it has spun "out of control" in a way that often "favors only the prosperous."

We have seen people in powerful positions in health care who do so "through corruption and deceit and the silencing of dissent"

So let those of us in health care join President Obama in this aspiration:

America, in the face of our common dangers, in this winter of our hardship, let us remember these timeless words. With hope and virtue, let us brave once more the icy currents, and endure what storms may come. Let it be said by our children's children that when we were tested we refused to let this journey end, that we did not turn back nor did we falter; and with eyes fixed on the horizon and God's grace upon us, we carried forth that great gift of freedom and delivered it safely to future generations.

Post Title → An Inaugural Moment to Improve Health Care

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.

Post Title → Drug Company Claims "Disparagement" by Proxy

Was GSK Merely Incompetent About Medical Informatics, Or Is There a Management Directive To Avoid Specialists Who Might Find "Unacceptable" Problems?

At my post "GSK, Avandia and Medical Informatics: More on Why Pharma Fails" I outlined repeated rejection of Medical Informatics expertise by GSK, based on what I believed essentially to be the narrowminded and tunnel-visioned thinking of information technologists and others in pharma. I wrote:

It is my belief that a view [at GSK] of medical informatics professionals as "writers of algorithms to solve business problems" reflects a fundamentally narrow and mechanistic view of the field, or perhaps a mislabeling of the position as being one of Medical Informatics. The lack of a requirement for formal Medical Informatics education and training suggests the latter.

The U.S. Institute of Medicine (IOM) of the National Academy of Sciences seems to agree with that assessment, as I pointed out in another post entitled "IOM gets it regarding Medical Informatics." The IOM recommends:

...that CDER [FDA's Center for Drug Evaluation and Research] build internal epidemiologic and informatics capacity in order to improve the postmarket assessment of drugs. In recognition of the limitations in human resources in the current employment market to meet this role, a combination of advancing professional skills through continuing education and support for academic training programs is needed.

and that

Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate.

A story in today's Wall Street Journal raises additional questions about what appeared to simply be strategic missteps in talent management (recognition and acquisition of new and/or enhanced skills and emerging fields of value to an organization).

Perhaps these were not strategic missteps at all, but simply a manifestation of a calculated policy set at higher levels to avoid discovering - beyond a certain point and before a certain time - information that might adversely affect a new drug's FDA acceptance, marketing, and sales. This might be accomplished through what might be called "internal capabilities inhibition via talent mismanagement."

The WSJ story today reports on actual directed, purposeful attempts by GSK to suppress possible adverse effects information about Avandia, as well as silence a number of its clinician critics. Those critics had prescribed the drug in good faith to their patients and noted troubling responses in the form of heart failure and pulmonary hypertensive (high pressure in the arteries of the lungs) side effects.

Wall Street Journal
Nov. 19, 2008

Doctors Claim Glaxo Dismissed Worries on Avandia (subscription required)

Drug Maker Tried to Make Physician at Maryland Hospital Stop Talking About Concerns; Company Defends Its Effort

By ALICIA MUNDY

HAGERSTOWN, Md. -- Last year, after news broke that the diabetes drug Avandia was linked to a high risk of heart attacks, reports that the drug's maker had tried to stifle safety questions from a prominent Duke University researcher years earlier provoked a furor.

Now it turns out that the Duke researcher wasn't alone in suggesting a tie to heart problems. A doctor from a small Maryland hospital [Internist Mary Money of Hagerstown, Md.] linked Avandia to congestive heart failure in 2000, but the drug's maker, GlaxoSmithKline PLC, rejected her warning and tried to make her stop talking about it with other doctors and hospitals, according to documents and interviews.

... The Senate and House in 2007 began looking at whether Glaxo suppressed information and threatened the Duke researcher, charges that Glaxo has denied. Now the Senate probe, led by Chuck Grassley of Iowa, is investigating whether Glaxo's efforts to defend Avandia's safety led to intimidation against other doctors who were suggesting possible links to cardiac dangers. Mr. Grassley, the ranking Republican on the Finance Committee, has demanded documents from Glaxo and is expected to release a detailed report on Avandia soon, according to staffers.

Earlier in 2007, a study in the New England Journal of Medicine reported that Avandia could raise the risk of heart attack by 43%. The FDA called for a black-box warning on the drug's label about the risk of congestive heart failure and heart attack.

Dr. Money talked recently about a patient who came to her in 1999 with congestive heart failure. "That fall, I had a woman patient with massive fluid overload and such shortness of breath that she had to sit up at night," she said.

The patient had begun taking Avandia two weeks earlier, and an echocardiogram showed high pressure in the arteries of the lungs. Dr. Money said she took the patient off the drug, and within a few days the symptoms almost disappeared.

In the next few months, Dr. Money and the head of the hospital's diabetes center, Stephen Lippman, found other patients who had similar symtoms.

Dr. Money alerted SmithKline Beecham, the name of the drug maker before a 2001 merger. The company met with her and Dr. Lippman at Washington County Hospital in Hagerstown in April 2000.

The two doctors presented data on 85 of their patients who had used Avandia, according to documents from the meeting. More than half of the patients had significant edema, or swelling, and about half of that group also had high pulmonary pressure and shortness of breath. Three had been hospitalized for congestive heart failure.

The meeting was a waste of time, Dr. Money said. "They came to tell us how wrong we were, not to listen," she said.

Meanwhile, a company consultant who called into the meeting from the University of Pennsylvania dismissed the Hagerstown doctors' echocardiograms as too poor to show anything useful.

"They suggested we were country bumpkins, and practically said, 'Don't worry your pretty heads. We have smarter people than you looking at this, and there's no problem,'" recalled Dr. Lippman, a physician who also holds a doctorate in molecular biology.

A GlaxoSmithKline spokeswoman, Mary Ann Rhyne, said Dr. Money's theories were "unsubstantiated" and she was misinterpreting journal articles to support her case.

The next month, two SmithKline executives wrote to the hospital's chief of staff, calling on him to stop Dr. Money from talking about her concerns to other hospital doctors.

"[W]e respectfully ask that your hospital not involve itself in the dissemination of information which has not been substantially verified, and that you take immediate steps to stop the dissemination of this unsubstantiated information to your medical staff," said the letter, signed by two SmithKline executives, which was viewed by The Wall Street Journal.

In effect, GSK is saying that these clinicians had no "right" to report their "unsubstantiated" findings to anyone without the company's "approval." That is the height of corporate hubris, especially in a country where freedom of speech and freedom of opinion is constitutionally guaranteed.

Unless these clinicians were fabricating their findings with ill intent, they certainly had very right to report their findings to anyone they chose. It is up to those so informed to make up their own minds based on the evidence and on trust.

But I state the obvious.

The company acted in a manner that might be construed as interference with medical practice and communication, and it seems to me potential interference with employment, by going to these doctor's superior. One must ask, who, exactly, did the company believe was required to perform the "substantiation" of adverse events information before the private clinicians could speak to others?

GlaxoSmithKline's Ms. Rhyne said the letter was justified. "When GSK learns about statements by physicians that are inconsistent with the scientific data on its medicines, it has the responsibility to do what it can to correct these inaccuracies," she said.

Resonsibility to whom, exactly? Its shareholders seem high on that list. Where do patients fit in to the taxonomy of corporate responsibility ?

It would seem to me the company also has the responsibility to maximize its ability to identify adverse events as soon as possible and as scientifically as possible, and conduct its talent management activities in a manner to enhance that capability.

Glaxo upgraded the warnings on Avandia's label more than a dozen times between 1999 and the 2007 black box, the strongest level of warning. One change, in 2001, said the drug could lead to excessive edema, which in turn could lead to congestive heart failure.

Better late than never.

Or perhaps not so much. From Alison Bass's blog:

It was not until 2007, after The New England Journal of Medicine published a meta-analysis showing an increased risk of heart failure among patients taking Avandia, that the FDA put black box warnings on the drug. (It's worth noting that researchers would never have been able to do this meta-analysis if not for the New York State Attorney General's lawsuit against GlaxoSmithKline for deceiving physicians and consumers about another of its drugs, the antidepressant Paxil; as part of settling that lawsuit, Glaxo agreed to post the findings of all its clinical trials, including those about Avandia).

Of one thing I am certain: diabetics did not need the additional problems caused by this drug before the black box warnings, when other proven, effective and less expensive therapies were readily available.

Perhaps that warning might have appeared sooner if GSK officials had not taken the stance that the value of Medical Informatics professionals is simply "to write algorithms to solve business problems." I wonder if a strategy of managing the narrative through questionable practices such as bullying and intimidation, while rejecting new fields of scientific endeavor, might be two sides of the same coin. (My own experiences are admittedly anecdotal, but formally trained medical informatics professionals are rare in pharma, and even at Merck I was kept an arm's length from adverse events informatics activities despite pointing out my expertise, for reasons never explained satisfactorily.)

My jobseeking experiences with SKB/GSK on informatics date back to 1996 or so. Rejections were the rule, even in one case in 2000 when I came highly recommended by their own senior internal recruiter after demonstrating the information system I built at a major hospital to detect drug and device adverse events in the field of invasive cardiology, and in 2004 when I again came highly recommended by their own retained British recruiter at Armstrong Craven Ltd.

I therefore raise the question:

Could my experiences and that of other informaticists with special competencies in building clinical IT to enhance adverse events data management have been a manifestation of a larger, somewhat unpublicized strategy? That is, a strategy meant to inhibit or suppress the employment and empowerment of individuals with formal training and expertise in newer scientific domains that might prematurely "endanger" the lifecycle of blockbuster drugs?

Perhaps the talent management activities, minutes, and hiring/layoff practices of relevant GSK departments and divisions should be scrutinized, in addition to the current Congressional scrutiny of specific instances of corporate arrogance as in today's WSJ article.

-- SS

Post Title → Was GSK Merely Incompetent About Medical Informatics, Or Is There a Management Directive To Avoid Specialists Who Might Find "Unacceptable" Problems?

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."

Post Title → Silverglate on How Corporate Academic Leaders Try to Control the Message

"Docs Ditched After Undesirable Diagnosis"

From the Johannesburg, South Africa Star, this story, entitled "Docs Ditched after Undesirable Diagnosis," has some eerie echoes of the past:

When medical specialists diagnosed at least 10 cases of manganese-specific illnesses at a factory in Cato Ridge, KwaZulu Natal, the Assmang manganese company dumped them 'like hot potatoes'.

They replaced them with a new team of doctors that revised the diagnoses to suggest the sick workers might be alcoholics, drug abusers or victims of Aids.

All 10 workers had also been certified previously by the Compensation Commissioner as being permanently disabled as a result of manganism, an occupational disease caused by exposure to excessive levels of toxic manganese.

Another 27 workers, also earmarked by doctors as possibly suffering from manganism, were also 'cleared' by the new team of medical doctors and some were put back to work.

This emerged on Wednesday during the testimony of Dr Susan Tager to the Department of Manpower inquiry into worker sickness and toxic dust exposure at the factory.

Tager, a senior Johannesburg neurologist who heads the movement disorders clinic at Wits University, expressed surprise that Dr Murray Coombs, a new member of the Assmang expert panel, had rubbished her diagnoses - even though Coombs had not seen or physically examined any of the 10 workers and based his opinion on a review of their medical files. Coombs, from Elixir Corporate Health Solutions, is employed by Assmang as an occupational health consultant.

We have often discussed how health care organizations may try to shut up doctors who might say something that goes against their vested interests. In particular, we have frequently discussed how corporations that sponsor clinical research on their own products have suppressed research unfavorable to these products (see relevant posts here). But it seems like all sorts of organizations now feel free to try to shut up physicians who say things counter to their interests, whatever these may be.

We have also often discussed how health care organizations cultivate physicians who might help them market their products. Again, we have most often discussed how biotechnology, device, and pharmaceutical corporations may cultivate "key opinion leaders," who seem happy to to promote the organization's line, at least while wined, dined and paid well. But it seems like all sorts of organizations now feel free to recruit compliant physicians happy to say what the organizations want.

The eerie echo is of the case of Dr David Kern, fired from his academic position after he tried to present an abstract on a new occupational disease, now called flock workers' lung,(1) in a way that offended leaders of the company whose workers acquired the disease (see summary on the Scientific Misconduct Blog here).(2) That company also recruited a new physician to investigate the disease outbreak,(3) but as far as I can tell, he never put anything on the public record about the results of his investigation, and what happened to the patients with flock workers' lung is unknown.

Thus, both these cases illustrate how directly patients may be affected by companies eager to shut up physicians, especially physicians warning of occupational disease.

References

1. David G. Kern, Robert S. Crausman, Kate T.H. Durand, Ali Nayer, Charles Kuhn III. Flock Worker's Lung: Chronic Interstitial Lung Disease in the Nylon Flocking Industry. Annals of Internal Medicine 1998; 129: 261-272 (Link here.)

2. Shuchman M. Secrecy in science: the flock workers' lung investigation. Ann Intern Med 1998; 129: 341-344. (Link here.)

3. Fulks JR. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337:1314-1319. (Link here.)

Post Title → "Docs Ditched After Undesirable Diagnosis"

Merger Mania Redux: the Case of the Carilion Health Care System

The Wall Street Journal published an article on how one not-for-profit hospital system came to dominate its market, and the effects of that domination on local health care.

How the System Became Dominant

The WSJ article documented how a hospital merger created a vertically-integrated health care system. Note that in the old days of "merger mania," there was a lot of buzz in the health care research and policy circles about how creating such integrated systems to benefit quality and access, and lower costs. This rationale appears below.

In 1989, the U.S. Department of Justice tried but failed to prevent a merger between nonprofit Carilion Health System and this former railroad town's other hospital. The merger, it warned in an unsuccessful antitrust lawsuit, would create a monopoly over medical care in the area.

After the 1989 merger, Carilion continued to operate Roanoke's two hospitals separately. It later consolidated the hospital boards and in 2006, transferred most of Roanoke Community Hospital's staff and services to a renovated and enlarged Roanoke Memorial Hospital.

The moves eliminated any hospital competition in Roanoke proper....

[Carilion CEO Dr Murphy] was convinced that the cost and quality of care in Roanoke could be improved if doctors worked in a more centralized system. In June 2006, he announced a seven-year, $100 million plan to transform Carilion into a multispecialty clinic, like the Mayo Clinic.

Carilion began approaching private physician groups, offering to buy their practices and pay their salaries.

We shall see what effects CEO Dr Murphy's advocacy of more centralization had.

Effects on Costs

The domination by a single vertically integrated health care system apparently lead to rising costs.

Nearly two decades later, the cost of health care in the Roanoke Valley -- a region in southwestern Virginia with a population of 300,000 -- is soaring. Health-insurance rates in Roanoke have gone from being the lowest in the state to the highest.

That's partly a reflection of Carilion's prices. Carilion charges $4,727 for a colonoscopy, four to 10 times what a local endoscopy center charges for the procedure. Carilion bills $1,606 for a neck CT scan, compared with the $675 charged by a local imaging center.

Alan Bayse, founder of a local benefits-consulting firm who has sold health insurance in the area for 30 years, says health-insurance rates in the Roanoke Valley used to be 20% lower than in Richmond, Virginia's capital, and the lowest in the state. Today, he says, they are the highest in the state and 25% higher than in Richmond, citing rate information from insurer Cigna Corp. Anthem, another health insurer, says its rates are 6% higher in Roanoke than in Richmond.

Mr. Lionberger, whose construction company has about 100 employees, says his health-care costs have risen 50% over the past three years, hampering his ability to compete with contractors from other parts of the state.

While the increasing domination by the system been associated with increased health care insurance rates, its leadership has aggressively pursued patients who failed to pay their share of its exaggerated bills.

The Roanoke City General District Court devotes one morning a week to cases filed by Carilion. In its fiscal year ended Sept. 30, Carilion says it sued 9,888 patients, garnished the wages of 5,478 people and placed liens on 3,920 homes. Carilion says the people it takes to court have the means to pay their bills.

When some patients don't pay their bills, Carilion places liens on their homes. Carilion says it doesn't track how many liens it has outstanding, but the close to 4,000 it filed in 2007 'is representative of a typical year,' Mr. Earnhart says. Carilion doesn't foreclose on homes and only collects when properties are sold, he says.

Dr. Murphy says Carilion only sues patients and places liens on their homes if it believes they have the ability to pay. 'If you're asking me if it's right in a right-and-wrong sense, it's not,' he says. But Carilion can't be blamed for the country's 'broken' health-care system, he says.

Ah, yes, the "broken" health care system made me do it, says CEO Dr Murphy.

Decreasing Access

One effect of the merger seems to be a squeeze on physicians who are not part of the integrated system, which presumably will decrease, not improve access to health care.

Some doctors who chose to remain independent say the number of patients referred to them by Carilion physicians plummeted. Carilion controls a large proportion of Roanoke's referrals because it employs a majority of doctors who make them, such as family practitioners, pediatricians and emergency physicians.

Joseph Alhadeff, an orthopedic surgeon who is a member of a private practice called Roanoke Orthopedic Center, says the number of joint replacements he performed dropped off sharply after he stopped getting such referrals from Carilion doctors, prompting him to plan to relocate to Pennsylvania. 'I spent seven years building up a practice and watched it evaporate in six months,' he says.

In fact, it appears that the integrated system was out to decrease the business of physicians not in the system.

Geoffrey Harter, an ear, nose and throat doctor at another Roanoke private practice, Jefferson Surgical Clinic, says Carilion-employed colleagues told him the hospital system asked them not to refer patients to doctors it didn't employ, calling such referrals 'leakage.' Keeping referrals within Carilion is lucrative for the hospital system because it ensures tests and procedures performed on patients take place at Carilion facilities.

Dr. Murphy says Carilion uses the term 'leakage' in internal marketing discussions and that he would rather see its doctors refer patients to other Carilion doctors to optimize their care. But he says Carilion doesn't require its doctors to keep referrals in-house even though it would be legal to do so.

Meanwhile, as the integrated system grew more powerful, its leadership appeared to use other tactics that have become all too familiar to readers of Health Care Renewal

Silencing Criticism

As tension between Carilion and Roanoke's independent doctors grew in 2006, a group of 200 doctors formed an organization called the Coalition for Responsible Healthcare to protest the Carilion Clinic plan. The group posted a petition on its Web site and put up billboards around Roanoke that read: 'Carilion Clinic. Big Dream. Big Questions.' The local newspaper, the Roanoke Times, covered the controversy in a series of articles written by its health-care reporter, Jeff Sturgeon.

A few months later, in March 2007, the Roanoke Times moved Mr. Sturgeon off the health-care beat after Carilion complained repeatedly about his coverage. Carilion says it communicated its displeasure to the paper's editors, but never asked that Mr. Sturgeon be reassigned. Carilion withdrew most of its advertising from the paper, but says it did that as part of a reallocation of its ad budget.

Follow the Money

As the system became more dominant, and more profitable, more money accrued to its top leaders, particularly, of course, its current and former CEOs.

In 2001, Dr. Murphy took the nonprofit hospital system's helm. Dr. Murphy, ... has a medical degree from Harvard but doesn't practice medicine....

Fueled by large, untaxed investment gains, Carilion's profits have risen over the past five years, reaching $107 million last year. Over the same period, the total annual compensation of its chief executive, Dr. Murphy, nearly tripled to $2.07 million. His predecessor, Thomas Robertson, received a lump-sum pension from Carilion of $7.4 million in 2003, on top of more than $2 million in previous pension payouts.

Carilion says Dr. Murphy's compensation is in line with comparable health-care organizations and notes he doesn't receive car allowances, a spousal allowance or club memberships. It says Mr. Robertson's pension accrued over a 32-year career at Carilion.

Members of Carilion's board of directors also seemingly profited from their relationship with the hospital system. The WSJ documented some major financial relationships among the hospital and companies in which board members had an interest.

A large part of the clinic conversion's costs have involved the construction of a new medical campus around Roanoke Memorial Hospital that began several years earlier.

The lead contractor building the site is Swedish construction giant Skanska. But one of the project's biggest beneficiaries has been J.M. Turner & Co., which is owned by Carilion board member Jay Turner. Carilion says it paid J.M. Turner a total of $14.9 million in direct contracting work from 2004 to 2007.

Dr. Murphy says Carilion's board authorized 'arm's length work' with J.M. Turner, but adds that "a case could be made that we shouldn't award work to J.M. Turner to avoid the appearance of impropriety."

Mr. Turner isn't the only Carilion board member with a financial stake in the new medical campus. Another board member, Warner Dalhouse, has invested in a hotel being built on the campus to accommodate patients and their families. HomeTown Bank, a local bank Mr. Dalhouse founded and of which he was until recently chairman, is financing the hotel's construction. Dr. Murphy and Mr. Turner sit on HomeTown Bank's board.

Carilion and Mr. Dalhouse say he didn't make his $130,000 investment in the hotel until after Carilion sold the parcel to Texas developers in early 2006. 'I wasn't dealing with Carilion. I was dealing with the new owners of that land who had paid fair market value for it,' Mr. Dalhouse says.

Management versus Mission

The Carilion Health System's statement of mission and vision are as follows

Mission Statement

Carilion Health System exists to improve the health of the communities it serves.

Vision

- Assure accessible, affordable, high quality healthcare that meets the needs of the community
- Motivate and educate individuals to improve their health
- Champion community initiatives to reduce health risk

Yet, the investigative reporting by the WSJ has shown how the increasing domination of local health care by the Carilion Health System has made health care less accessible and less affordable, despite its leaders' proclamations to the contrary. It has "educated" the local newspaper to reduce its critical coverage of the system's activities. Thus, the bigger and more dominant the health care organization, the more mission-hostile its leadership is likely to be. Meanwhile, increasingly mission-hostile leadership tends to become increasingly lucrative for its practitioners.

I submit that if we really want better quality, more accessible, more reasonably priced health care, we need to bust the new health care "trusts." We need smaller health care organizations with ethical leadership truly devoted to the health care mission. We need organizations whose governance is representative of key constituencies; accountable to patients, health care professionals, and the public at large; open and transparent; and which upholds clear ethical principles.

Post Title → Merger Mania Redux: the Case of the Carilion Health Care System

Shut Up, They Explained (to Ezetimibe Critics)

One of our scouts alerted me to a remarkable editorial just published by Harrison, Brown and Raggi on the ezetimibe controversy [Harrison DG, Brown WV, Raggi P. Enhanced hype. Am J Cardiol 2008; 102: 368-369. Link here, requires subscription.]

We have posted before (as have many others,) about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how the trial seemed to be designed and implemented so as to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected, (later reversed after it was publicized.) It also turned out that the supposedly "independent" panel responsible for that decision included a majority of members who had previous financial ties to Merck and/or Schering-Plough.

The ENHANCE trial was not meant to determine whether ezetimibe had any effects on clinical outcomes, that is, whether it made patients feel or function better, avoid morbid events, or live longer. Its focus was on whether the drug reduced the thickness of arterial walls in patients with very high cholesterol levels. The study failed to show even this effect.

Since no previous study had shown that ezetimibe leads to symptom reduction, functional improvement, prevention of morbidity, or extension of life, it was surprising that the American College of Cardiology and the American Heart Association rushed to the drug's defense, counseling physicians not to take patients off it. Why continue to give patients a drug that has never been shown to provide clinical benefit? In this post, we wondered whether this enthusiasm unsupported by clinical research evidence had to do with undisclosed conflicts of interest affecting the defenders of ezetimibe.

Since then, in the continuing absence of evidence about the benefits of ezetimibe, there has been continuing controversy over its use. Harrison, Brown and Raggi continued in this vein. They clearly sided with the American College of Cardiology's statement that physicians should not take patients off ezetimibe, which they contrasted with what they characterized as

hysterical coverage from Web sites, news organizations, and cardiologists who seem to seek high visibility.

So the "hype" and hysteria, according to Harrison, Brown and Raggi, were criticisms of attempts to manipulate the ENHANCE trial, and observations about the lack of clinical evidence supporting the use of ezetimibe. What made their article remarkable, however, was its suggestion that purveyors of "hype" and "hysteria" as defined by Harrison, Brown, and Raggi, should just shut up. First the three authors wrote,

Strong statements regarding guidelines or policy in the use of this drug by cardiologists (with little background in lipid research and atherosclerosis biology) are inappropriate and certainly premature.

Then,

unsupported premature claims regarding a drug’s effectiveness or lack thereof should be conveyed properly, as in the case of the American College of Cardiology’s official statement. There seems to be a recent love affair with the issuance of headline-grabbing statements to the press, and this should be discouraged. When done in haste without proper study and thought, they appear to be self-aggrandizing, and at worse, they are very misleading.

So this editorial is noteworthy not because it defended ezetimibe, or belittled its critics, but because it seemed to question the right to criticize the established dogma.

Obviously, the authors of the editorial have no legal authority to censor those whose views offend them. But even veiled questioning of the right to express dissent are contrary to the core values of science and medicine. For science to advance, open discussion and criticism of methods, results and interpretations is vital. For physicians to take the best possible care of patients, they must have access to the best possible evidence from clinical research, even if that evidence offends the powers that be or those with vested interests.

A clue as to why the authors took such an extreme position may be found in the last sentence of their article,

In the case of ezetimibe, we are concerned that this drug or its makers will be eliminated on the basis of hyperbole, misinformation....

Why would they be so worried as to raise the hyperbolic concern that the controversy over ENHANCE could cause ezetimibe, and even Merck and Schering-Plough to be "eliminated?" A quick Google search revealed disclosed that the authors collectively have multiple relevant financial relationships that they did not disclose.

• Dr David G Harrison is on the scientific advisory board of Atherogenics, Inc.
• Dr W Virgil Brown, according to a financial disclosure statement provided by the National Lipid Association, on whose board he sits, "has advisory relationships" with AstraZeneca, Bristol-Myers Squibb, Merck, Merck Shering Plough, Pfizer, Reliant, Kos, Lilly; has "research relationships" with AstraZeneca, Lilly, Kos, Pfizer, Takeda; has "educational relationships" with Abbott, Lilly; and has "speakers' bureau relationships" with AstraZeneca, Bristol-Myers Squibb, Merck, Merck Shering Plough, Pfizer, Reliant, Kos, Lilly, Abbott, Takeda, Kos.
• Dr Paolo Raggi, according to disclosure statements provided by HDCN for a 2001 meeting, "received grant support and honoraria from Genzyme Therapeutics and is a stockholder in Pfizer Inc;" and according to disclosure statements provided by the Office of Continuing Education for Johns Hopkins University School of Medicine for a 2007 meeting, received an honorarium from Amgen, and received grants, consulting fees, and speakers' honoraria from Genzyme.

Perhaps the authors' financial identification with Merck and Merck Schering-Plough, and with the pharmaceutical and biotechnology industries in general lead to such exaggerated concern. In any case, the authors should have revealed these financial relationships, and allowed readers to decide whether they might have affected their views. Nonetheless, while conceivably such relationships could have somewhat explained the authors' partiality to censorship, it does not excuse it.

As documented on the FIRE web-site, it is now commonplace for academic administrators to try to silence those who disagree with the prevailing campus dogma. This impulse to censor those who provide inconvenient opinions or facts now seems to be extending to the scholarly medical literature. It is ironic that those calling for censorship simultaneously seem loathe to reveal their financial relationships with those with vested interests in maintaining the status quo.

The inconvenient truths that we censor or hide surely will return to afflict us.

ADDENDUM (3 August, 2008) - See also comments by anonymous blogger "PM" on Gooznews.

Post Title → Shut Up, They Explained (to Ezetimibe Critics)

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.

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

Linking the Anechoic Effect and Suppression of Research to Conflicts of Interest and Mission-Hostile Management: the VCU Case

We recently discussed ties between Virginia Commonwealth University (VCU) and the tobacco industry. Here we discussed how the university got a grant which gave proprietary control of any research results to the sponsor, Philip Morris, a tobacco company, not the academic researcher, and required the grant itself to be secret. Here we discussed issues raised by the university president's position on the board of directors of another tobacco company, Universal Corporation.

A recent article in (Richmond, VA) Style Weekly alleged that VCU faculty fear publicly criticizing the university's relationships with tobacco companies:

Virginia Commonwealth University researchers and faculty who fear reprisal for speaking out against a secret smoke-filled-room research agreement between the school and Philip Morris USA are taking extraordinary steps to protect themselves.

A form letter, which many say they plan to sign and send to the university’s Human Resources Department, is being circulated via e-mail that states 'on the record that I am concerned about a May 22nd New York Times report' about the Philip Morris research agreement’s covenants that restrict publication and use of research findings in violation of university policy.

The letter cites a fear of retaliation 'if I openly express my concerns,' and its purpose is 'to document and date this apprehension in case action is later taken against me that could be linked to a decision to voice my disapproval .…'

According to numerous VCU faculty and staff members, the letter is the only protection they feel they have against the possibility of unfair treatment for speaking out about what they consider a clear violation of research ethics. While it’s unclear how many faculty members are contemplating signing the form letter, Style Weekly has interviewed half a dozen faculty members and researchers who say they plan to sign it.

They all spoke on the condition of anonymity.

'Part of the paranoia comes from seeing what already has come to pass,' one high-level researcher on federal grant projects says of 'senior people at VCU' who have left because of the Philip Morris deal. 'We’ve all come to the conclusion that the potential risks from [signing the letter] are minimal compared to the risks of not doing it.'

The article also alleged that some of the fear may be due to the possibility that the university will soon have much larger ties to the tobacco industry than have been heretofore revealed.

A pending proposal, highlighted at various meetings by Jerome Strauss, dean of the VCU School of Medicine, could link federal grant funds with 'several million dollars' — initially about $30 million, but since scaled back — directly from Philip Morris for the creation of a women’s health center. Numerous college sources cited the deal, with one providing details that included in an early draft proposal for the center.

The tentatively named Philip Morris Women’s Health Center would examine disparities between women’s health care and other areas of health care, but according to one source, Strauss has said the exact focus could be affected depending on Philip Morris’ participation.

This case now illustrates the inter-relationships of several topics we commonly discuss on Health Care Renewal: conflicts of interest affecting health care decisionmakers, suppression of research, and the anechoic effect. To look at it another way, it shows academic medical institutions lead by the conflicted are prone to take actions hostile to their clinical and academic missions.

So as I wrote in my last post, this case too makes a striking argument for the need to drastically reform the leadership and governance of health care organizations, and academic medical centers in particular.

Post Title → Linking the Anechoic Effect and Suppression of Research to Conflicts of Interest and Mission-Hostile Management: the VCU Case

A Hospital CEO Censors the Internet, Only to See "the Handwriting on the Medical Chart"

The Fort Worth (Texas) Star-Telegram just ran a six-part series about the misfortunes of the JPS Health Network, a large county hospital network and health care system. The story had several twists. (See this page for links to the latter part of the series and related articles. The first three parts are here, here and here. )

The series emphasized the overcrowding and long waits, problems with equipment and the physical plant, and jaded, demoralized staff that unfortunately fit stereotypes of underfunded public hospitals. Here are some quotes from the introduction to the first part of the series:

The waiting room reeked. Along a crowded hallway, patients lay in beds, with only a thin curtain for privacy. Nurses readying for a new case in surgery noticed blood, bone and globules of fat on the walls and floor and stuck to wheels of carts.

They were greeted last year at an overburdened emergency department where the staff could be robotic and hardened to patients. Sometimes, inexperienced nurses evaluated the sick and suffering.

Some patients were shuffled to a stifling back room to wait. Medical records, crucial lab results -- even patients -- got lost. Staff didn't notice when one Alzheimer's patient walked home in 100-degree heat. Another patient was dismissed because doctors didn't get lab results indicating a life-threatening disease.

The trauma center was described as a war zone. Operating rooms as chaotic. In too many places, instruments were broken, rooms dirty, linens threadbare.

These problems sound unfortunately typical of an impoverished public hospital system trying to care for even more impoverished patients.

But there were several twists to the story. The first is that hospital system executives were instrumental in setting in motion the discovery of these problems, but they then apparently first tried to ignore what was discovered.

Many of the problems were revealed by reports by InSight Advantage, a Houston-based consulting firm paid more than $600,000 by hospital system managers to assess the system's care and condition. However,

[The reports] were never presented to the JPS board. The Star-Telegram recently obtained a copy.

When [JPS Health Systems CEO David] Cecero was asked about the reports' findings, he said he couldn't answer: He hadn't read the documents or been briefed on them.

'I don't think it's my job or my role to read every report that comes through this organization,' he said. 'That's why we have an executive team.'

JPS board Chairman Steve Montgomery said he was unaware of the InSight Advantage study until the Star-Telegram raised questions about it. Then he asked for a copy.

The second twist is that while the reports painted a picture of a (sadly not atypically) impoverished hospital system trying to take care of even more impoverished hospital patients, the Star-Telegram claimed that JPS was far from impoverished.

From the first part of the series:

Boosted by tax funding other local hospitals don't get, JPS has been racking up fat surpluses -- nearly $97 million last year alone.

But the cash has not helped a dedicated core of doctors and nurses overcome the system's callousness, ineptitude and filth. JPS is a hospital that many of its own doctors wouldn't recommend.

In the past six years, Tarrant County property taxpayers have anted up $1.3 billion on the premise that the mission of the public hospital is to treat the indigent and needy. But a four-month Star-Telegram examination found that the Hospital District has squandered opportunities to improve care and compassion as it has chased insured patients pursued by every other Tarrant hospital.

As trash cans overflowed, so did the district's bank accounts. The district's investments swelled to $381 million last year, earning $22 million in interest. But nurses scrambled during surgeries for instruments that low-paid assistants couldn't identify.

Over five years, JPS grabbed $232 million from one federal program for the poor, and administrators said they banked much of it. Meanwhile, needy Tarrant County residents sometimes waited months for appointments, and others went without care because they could not afford the co-payments.

In a supplement to the series appeared:

Net income at JPS Hospital has quadrupled since 2001, and the hospital's investment funds have more than doubled. The nonprofit hospital in 2006 achieved a healthy 16 percent return on equity, the common measure of a hospital's profitability. In comparison, Harris Methodist Fort Worth earned a return on equity in 2006 of 7 percent.


FY 2001, 2002, 2003, 2004, 2005, 2006
Net income (in millions) $17.4, $25.0, $25.0, $45.1, $54.1, $77.7
Investments (in millions) $112.2, $132.6, $159.5, $111.4, $118.0, $255.0
Source: Medicare cost report information from Cost Report Data Resources and American Hospital Directory

It also seemed also that the hospital had become particularly good at raising its "rack rates," that is, the fees it charged uninsured patients (while it negotiated substantial discounts for patients whose insurance companies paid on their behalf.)

Per the third part of the series:

Since 2001, JPS has aggressively pushed up its retail prices, outpacing the rate of increases at eight other Texas hospitals that the Star-Telegram examined. Seven years ago, the hospital's retail price was $1 for every 73 cents in costs, according to reports that JPS filed with the federal government. By 2006, JPS was charging $1 for about every 28 cents in costs - a markup of 257 percent.

This strategy may have been designed to increase Medicaid reimbursement.

JPS officials are frank about saying that the increases were driven by the opportunity to maximize Medicaid revenue, and they don't apologize for that. As JPS' burden of charity care has grown, and as the federal government has clamped down on rates Medicaid pays, administrators say they have had to strategize ways to draw more money from supplemental government funds.

Unfortunately, the higher the "rack rates," the higher the bills faced by uninsured patients, patients who are likely to be poorer than insured patients.

Chief Financial Officer Gale Pileggi says that she is aware the higher charges hurt some people and that the hospital is trying to deal with the dilemma.

The JPS board, she says, understands that 'it has to find a way to help the working poor who still cannot afford the hospital charges.'

JPS board Chairman Steve Montgomery said hospital officials have told him that few people charged at the full rate actually pay the entire bill.

'It's what truly helps me sleep at night,' Montgomery said.

But at many hospitals, some patients do get slapped with the highly inflated retail rate, said Glenn Melnick, a hospital pricing expert at the University of Southern California in Los Angeles. About 5 to 10 percent of all hospital patients are asked to pay the full retail price, he said.

'One of the biggest implications of these rising charges is that while they were driven by hospitals trying to increase their revenue from Medicare and Medicaid, they have this very nasty effect of generating highly excessive prices for the uninsured,' Melnick said.

In addition, the high charges undermine people's faith in hospitals and healthcare, he said.

The third twist occurred after the first stories of the Star-Telegram series appeared. The newspaper's blog reported:

But JPS employees won't be able to read the rest of the series online - not at least while they are at work.

JPS Chief Executive David Cecero and Chief Financial Officer Gail Gale Pileggi decided to block internet access to the Star-Telegram.com site.

'It was a decision that was discussed with the administration, being Mr. Cecero and Gail Pileggi, and how to deal with news issues and how many people have the right to read and do things during the work day,' said JPS spokesman Robert Earley, senior vice president of public affairs and advocacy.

Despite JPS' censorship, dozens of blog postings on the stories were made by people identifying themselves as JPS employees.

JPS Board Chair Steve Montgomery called the move 'stupid.'

Perhaps it should not be a surprise that a CEO whose latest move his board chairman called "stupid" lost his job soon after, although with the now de rigeur generous severance package (again, per a Star-Telegram article):

JPS Health Network CEO David Cecero was surprised by the board decision on Wednesday to cut ties with him, it's only because he refused to read the handwriting on the medical chart.

County taxpayers will have to pay him $775,268 whether he leaves his office tomorrow, on Sept. 30 or at the end of July 2009, as the terms of his negotiated leave-taking call for.

So add David Cecero to our gallery of failed health care executives, hospital and health care system division. His regime shows again how current health care leaders may pursue financial objectives at the expense of access, quality, cost control (for patients, if not for executives), and staff morale. As the Star-Telegram put it, 'the handwriting was on the wall' because

The district might be in the best financial shape it's ever witnessed, but the core mission of providing care to an expanding universe of indigent patients has suffered in the process.

Meanwhile, the story also showed when bad news appears, the first impulse many health care executives now have is to ignore it, their second, to censor it, but not to deal with its cause.

Once again, I will argue that to put patients first, we need to make the governance of health care organizations, starting with not-for-profit hospitals and academic institutions, more representative of key constituencies, accountable, transparent, and subject to clear codes of ethical conduct.

Hat tip: Schwitzer Health News blog.

Post Title → A Hospital CEO Censors the Internet, Only to See "the Handwriting on the Medical Chart"