Friday, November 28, 2008

What Me Worry? - Academic Leaders Blissfully Unaware of the Commercial Purposes of their Research Center

A few weeks ago, the Boston Globe published an investigative report on differences in reimbursements insurers and managed care organizations provide to different hospitals and hospital systems. One major bullet point was that the Partners HealthCare system, whose flagship hospitals include the Massachusetts General Hospital and the Brigham and Womens Hospital, received higher reimbursement rates than other well-known hospital and health care systems. A second was by some measures of quality, the major Partners teaching hospitals did not do better than other Boston hospitals.

In the resulting debate in the blogsphere (for example, see these posts and accompanying comments, on the Running a Hospital blog, and on the Movin' Meat blog,) some argued perhaps Partners really did deserve the extra payment. After all, the Massachusetts General Hospital and the Brigham and Womens Hospital are two of the most prestigious hospitals in the US, and indeed, the world. It is not implausible that this prestige arose from some real quality advantages. Furthermore, as we and others have argued, the available measures of quality, including those proposed to govern so-called "pay for performance" (P4P) in health care, are deeply flawed. For example, because of the Massachusetts General Hospital's reputation, it may attract the most difficult and complex patients, and these patients' severity and complexity of illness may have caused the hospital to have high mortality rates, despite the best of care.

Thus, at the time, the extra reimbursement going to Partners hospitals did not seem an issue for Health Care Renewal. But this week another series of stories came out about "Man's Best Hospital," (as it was called in "Samuel Shem's" House of God).... And they suggested that the Partners system may have quality problems of another kind.

Revelations about a research center at the Massachusetts General Hospital, and the renowned psychiatrist who ran it resulted from discovery legal proceedings. Lawsuits against several drug companies claimed that children were injured by atypical anti-psychotic drugs produced by several companies. The plaintiffs asserted that Dr Joseph Biederman's research was "crucial to the widespread acceptance of pediatric uses of antipsychotic medicines," (per Gardiner Harris reporting in the New York Times). The Massachusetts General Hospital's web-site notes that Dr Biederman is "Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD at the Massachusetts General Hospital, and Professor of Psychiatry at the Harvard Medical School."

According to the NY Times article, Dr Biederman pressured Johnson & Johnson, the manufacturer of Risperdal (risperidone), an atypical antipsychotic drug, to finance a research center at Massachusetts General Hospital,
E-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to 'move forward the commercial goals of J.& J.'
A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, where Dr. Biederman serves as chief.

A 2002 annual report for the center said its research must satisfy three criteria: improve psychiatric care for children, have high standards and 'move forward the commercial goals of J.& J.,' court documents said.

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company 'multiple times to propose the creation' of the center. 'The rationale of this center,” the message stated, “is to generate and disseminate data supporting the use of risperidone in' children and adolescents.

Furthermore, David Armstrong, writing for the Wall Street Journal, noted

Internal J&J records that are part of the plaintiffs' filing indicate that Janssen (Johnson & Johnson subsidiary) paid, or was requested to make payments, of $500,000 to help start up the center in 2002, another $200,000 for operating funds in 2003 and an additional $250,000 for 2004 activities. Janssen declined to comment on those figures.

Dr. Biederman was receiving direct compensation from J&J during those years, according to records obtained by Sen. Charles Grassley, who has been investigating drug-company payments to the Harvard researcher at others at academic medical centers. In 2001, Dr. Biederman was paid $58,169 by J&J although he reported to Harvard that he was only paid $3,5000, according to Sen. Grassley. In all, Dr. Biederman received more than $1.6 million between 2000 and 2007 from drug companies while reporting to Harvard receiving only several hundred thousand, Sen. Grassley's documents show.

Also, per the WSJ,

The emails also suggest that the company's marketing staff were involved in creating the institute and that company officials helped to write and vet research work done by Dr. Biederman and his associates.

Officials from Massachusetts General Hospital denied that they knew what was really going on at the Center. Per an article in the Boston Globe,

Massachusetts General Hospital issued a statement yesterday saying that the center, the MGH-Johnson & Johnson Center for the Study of Pediatric Psychopathology, existed from 2002 to 2006 and gave many researchers 'the infrastructure necessary to complete projects related to the psychiatric care of children in an efficient, expeditious, and integrated manner.'

The hospital controlled the center's programs, it said, and, 'The grant agreements stated that the center was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.'

The allegations in the Risperdal case 'have raised significant questions and concerns about the implementation of those agreements,' the statement said. 'The MGH takes these allegations very seriously and intends to investigate these issues thoroughly.'

Meanwhile, Harvard University denied any direct involvement. Per an article in Bloomberg News,

David Cameron, a spokesman for Boston-based Harvard Medical School, said Harvard isn’t involved with the J&J Center at Massachusetts General, a Harvard teaching hospital.

'Harvard Medical School does not ‘own’ any of its teaching hospitals,' Cameron said in an e-mail. 'While we are affiliated with them through academic appointments, all teaching hospitals are individually governed.'

A major theme of this blog has been how the leadership of ever larger and more dominant health care organization have forsaken their missions, and instead acted to threaten physicians' and other health professionals' core values. For example, a leader of academic medicine asserted that faculty were judged more for their ability to bring in money, to be "taxpayers," in his words, but not to teach, do research, or take care of patients. This occurred while health care organizations were increasingly run by people from the business world who had little experience in or knowledge of the care of patients, or of biomedical or clinical science.

The sorry tale of Dr Joseph Biederman now adds to the evidence that at even the most elite academic medical institutions commercial purposes may outweigh the academic or clinical mission. The remarkable feature of this story is that the leaders of the particular institutions involved seemed blissfully unaware of what was going on.

At best, the leaders of Massachusetts General Hospital did not seem to know what the purposes of their own so-called research units were. Although Harvard Medical School has long been identified with its prestigious teaching hospitals, and vica versa, now the Medical School says it was "not involved" in the hospitals' and its own faculty's research activities. It all has the smell of "plausible deniability." Maybe the leadership of ostensibly academic institutions no longer want to know too much about their institutions' academic activities, presumably as long as those activities brought in enough money to be good "taxpayers."

But if academic leaders claim to know nothing about and have no involvement in their organizations' academic activities, what sort of leaders are they, and what really are their missions?

Meanwhile, all too many medical academics cloak themselves in the mantles of their academic respectability while helping to hawk drugs and devices, while claiming to be perfectly uninfluenced by the tens or hundreds of thousands or more dollars they are making on the side, and uninfluenced by how the huge grants their sponsors hand to their institutions promote their careers, making their academic cloaks all the more showy.

For additional comment on this case, see this post in the Clinical Psychology and Psychiatry Blog, this one on the Alison Bass blog, and this one on the University Diaries blog.

ADDENDUM (1 December, 2008) - Also see this post on the Carlat Psychiatry Blog.

Wednesday, November 26, 2008

Questions of Benefits vs Risks for the UPMC Liver Transplant Program

Last week, the Wall Street Journal published an investigative report on the liver transplant program at the University of Pittsburgh Medical Center which provided a troubling view of some the issues affecting US health care.

Let me summarize the main points, as I would like to organize them, using quotes from the article, and my parenthetic comments.

Liver Transplantation Strategies at UPMC were Aggressive and Risky

Earlier this decade, UPMC made an aggressive bid to reclaim its leadership by hiring an innovative surgeon named Amadeo Marcos, who promised to double the number of liver transplants the hospital did.

Dr. Marcos delivered on his pledge. In doing so, however, he resorted to practices that some colleagues found questionable.

These practices included:

Lowering Standards for Donor Livers

To overcome a perennial shortage of organs, he used more livers from older donors.


A shortage of transplantable organs from cadavers is a perennial constraint on the number of liver transplants. Dr. Marcos overcame this in part by using organs from so-called expanded-criteria donors -- deceased people who had been older or sicker than preferred liver donors.

In the 2½ years before Dr. Marcos joined UPMC, the average age of its deceased liver donors was 41, according to UNOS. By 2003, it was 47, or nine years above the national average.

And while in 2000 and 2001, UPMC used an average of only 10 livers a year from patients older than 65, it used 45 in 2003.

Performing Transplants on Less Sick Patients (Who Are Less Likely to Benefit)

He transplanted some of these into relatively healthy patients for whom the risk-reward calculation was less certain.

In particular,

Dr. Marcos put some of these organs into patients who were in the early stages of liver disease, say Dr. Fung and Howard Doyle, who then worked in UPMC's transplant intensive-care unit. These were patients, they say, who sometimes didn't need a transplant.
'For the first time in years, we had people dying on the operating table or in the ICU,' says Dr. Doyle, now director of surgical critical care at Montefiore Medical Center in New York. At times, according to him, patients healthy enough to walk into the hospital before being transplanted died 'because they had a high-risk liver put into them.'
Data from the Scientific Registry of Transplant Recipients show that during Dr. Marcos's time at UPMC, 30 liver recipients died within two days of surgery. That was a death rate of 2.4%, versus a national average of 1.6%.


Liver patients are ranked by how advanced their disease is. Based on a series of blood tests called MELD, scores range from 40 for the sickest to six for the healthiest. Most experts now believe the risks of a transplant generally outweigh the benefits for patients with MELD scores of 14 or lower.

During Dr. Marcos's nearly six years at UPMC, it performed 441 liver transplants on patients with scores of 14 or lower, according to UNOS. That was 35% of the liver transplants performed during his tenure, and compares with fewer than 7% in the 2½ years before he arrived.

Using Live Donors (Who Donate Part of Their Livers, and Also Are At Risk From the Procedure)

He used partial livers from living donors, and then understated complications from the controversial procedure.

In particular,

Dr. Marcos sharply increased the number of transplants from living donors. In these, part of the liver of a healthy person is cut off and grafted into a sick patient. If all goes well, both pieces eventually grow to normal size. The procedure is controversial because it could be risky for the otherwise healthy donor.

UPMC did 150 such surgeries while Dr. Marcos was there, according to UNOS. No donors died. However, in 69% of the cases, the recipient had a MELD score of 14 or lower -- suggesting that UPMC was putting some living donors at risk to do transplants on patients in which the risks of the operation may have outweighed the benefits.

In addition, Dr Thomas Starzl, the liver transplantation pioneer for whom the UPMC center is named,

became suspicious of the low complication rates Dr. Marcos was reporting in adult living-donor liver transplants, say people familiar with the matter. In a textbook Dr. Marcos co-wrote, he said UPMC's rate of serious complications was zero for donors and 34% among a subset of recipients.
Dr. Starzl reviewed the 121 transplants UPMC had done involving removal of the donor's right lobe, a typical procedure in adult-to-adult living-donor liver transplants. Dr. Starzl's finding, according to people with knowledge of it: Though recipients' survival rate was only slightly lower than the national average, 60% of the recipients suffered life-threatening complications, ranging from bile-duct leaks to blood-supply problems -- nearly double the rate Dr. Marcos reported.
Dr. Starzl raised his concerns with UPMC chief Mr. Romoff and other officials, including the head of the department of surgery, Timothy Billiar, say the people familiar with the situation.

A tense six-month standoff ensued. Dr. Starzl, worried that UPMC was covering the matter up, sent his findings to a medical journal, according to people familiar with the events. Dr. Billiar asked it not to publish, on the ground that Dr. Starzl hadn't obtained patient authorization to collect the data. Dr. Billiar says that Dr. Starzl's paper would have jumped the gun on a peer-reviewed internal study he had requested from another surgeon, Wallis Marsh.

UPMC and Dr. Starzl compromised: Dr. Starzl would wait for the internal study, which would be reviewed by Pierre-Alain Clavien, a Zurich surgeon who pioneered a scale to measure complications in living-donor liver transplants. UPMC's final conclusions would be published.

In January, Dr. Marsh and Dr. Clavien confirmed Dr. Starzl's finding of a 60% rate of serious complications among recipients, documents seen by The Wall Street Journal show. The review also concluded that about 10% of the living donors had suffered serious complications, belying Dr. Marcos's claim that this number was zero.

Liver Transplantation Strategies at UPMC were Expensive

Hospitals charge $400,000 to $500,000 for a liver transplant. UPMC's transplant program produced $130 million of revenue in its latest fiscal year.

There Was No Evidence that the Liver Transplantation Strategies at UPMC Provided Benefits Outweighing Their Potential Harms

The WSJ article quoted many UPMC doctors, and gave Mr Paul Wood, the UPMC Vice President for Public Relations, multiple chances to rebut the articles' findings. Mr Wood did declare, "our core mission is nothing less than providing the best and most appropriate care for patients."

However, no one quoted in the article was willing to assert, much less justify, a claim that the aggressive tactics used during Dr Marcos' time at UPMC provided benefits that outweighed their risks, including in some cases their risks to donors as well as patients.

Another news article on the UPMC controversy published by the Pittsburgh Tribune-Review quoted Dr James Trotter, an investigator in the Adult-to-Adult Living Donor Living Transplant Cohort, did state "there's a survival advantage for people who undergo live-donor liver transplant versus waiting on the transplant list."

A quick look at the literature revealed an article from the UPMC program reporting a case-series of patients who received transplants from living donors.(1) The article showed that their survival rate was comparable to that for patients who received cadaver transplants. However, it did not include a control group, and therefore could nor provide even weak evidence that outcomes for patients receiving transplants from living donors are superior to those receiving them from cadavers. In addition, there is evidence that the risks to living donors are clinically significant. For example, a systematic review suggested that donor mortality may be more than 0.2%, and donor morbidity ranged from 0% to 90% in several studies, with a median of 16%.(2)

Thus, no defender of the strategies previously used at UPMC, nor any clinical research that I found provided strong evidence that the benefits of the use of living donors outweighed their risks to the donors, or to the recipients. Furthermore, no one put forward any evidence that the aggressive approach pushed by Dr Marcos generally provided benefits to patients that either exceeded those of a more conservative approach, or outweighed its apparent risks.

Perverse Incentives Favored an Aggressive, Risky Approach

As I noted above, the UPMC liver transplant program brought in a large amount of money, especially considering that the program provided transplants to nver more than 300 patients a year, according to a chart provided in the WSJ article. This enabled Dr Marcos to make a generous salary and maintain a lavish lifestyle.

UPMC set out to hire a surgeon who could restore the program to its former glory. It settled on Dr. Marcos, a dashing Venezuelan with a taste for Ferraris and Porsches, who specialized in the emerging field of transplants from living donors.

UPMC offered Dr. Marcos $500,000 a year and "additional incentive payments," a letter dated June 21, 2002, shows. Dr. Marcos came aboard as director of clinical transplantation....

This was in a context of a medical center run by businesspeople instead of clinicians, who were increasingly richly rewarded, a context that should be familiar to Health Care Renewal readers.

UPMC is a nonprofit hospital system whose income is largely exempt from taxes. Yet, it is increasingly run like a for-profit company, paying its executives high salaries, jumping into new activities and expanding abroad. Its quest to ramp up its transplant business shows how a drive for higher revenue, now common at nonprofit hospitals, could risk compromising patient care.

Dr. Marcos's nearly six years at UPMC coincided with rapid growth at the medical center. UPMC is one of the nation's most financially successful nonprofit hospital systems, with operations ranging from Pennsylvania to Ireland and Qatar. Even though three-quarters of its $7 billion in annual revenue is exempt from federal and local taxes, UPMC has acquired many of the trappings of large, for-profit corporations.

Its chief executive, Jeffrey Romoff, earned $4 million in the fiscal year ended June 30, 2007, and 13 other employees earned in the roughly $1 million to $2 million range. For their transportation, UPMC leases a corporate jet. Earlier this year, UPMC relocated its headquarters into Pittsburgh's tallest skyscraper, the 62-story U.S. Steel Tower.
Interval Summary

So, in my humble opinion, the UPMC liver transplant story illustrates how in the US we richly reward aggressive, high-technology, cutting edge and risky care, even in the absence of any good evidence that such care provides benefits to patients that outweigh its risks. Thus, is it any surprise that we provide a lot of expensive, risky care, but may have little to show for it?

Furthermore, breaking up the medical "guild" and handing control of health care over to bureaucrats, managers, and executives paved the way for a business culture of health care that richly rewards those on top, and enables cults of personality and imperial CEOs. This has lead to a culture that puts the self-interest of leaders over the mission to care for patients. The leader-centric culture also has proved intolerant of any criticism leveled at the fearless leaders. This leads me to my last point.

A Failed Attempt to Manage the Message

We blogged earlier about how the leaders of health care organizations try to "manage the message" so as to glorify themselves and hide their own flaws. In the coverage of the UPMC liver transplant service there was plenty of attempted message managing.

First, note that no one in the UPMC leadership who bore responsibility for the transplant program was willing to say anything. Dr Marcos appeared to be in an undisclosed location.

Dr. Marcos, 46 years old when he left UPMC, did not respond to numerous attempts to reach him, including a letter sent to his home. A lawyer who represented him in a court case last year said he hadn't been in contact with Dr. Marcos for months.

Justifications of the lavish compensation given to the CEOs of health care and other large organizations often includes their heavy responsibilities. Yet the CEO of UPMC was also unavailable for comment.

UPMC declined to make Mr. Romoff available for an interview.

Instead, it was left to Mr Wood to defend the UPMC program, not only in the WSJ article, but now in several letters to the editor. Unfortunately for him, he had little ammunition for this cause.

One example was how he had to respond to the issue of whether UPMC performed transplants on patients whose liver problems were not severe enough to make them the most appropriate transplant candidates. Note that the WSJ article stated that 35% of transplant recipients during the time of Dr Marcos' leadership had MELD scores less than 15, indicating that they had favorable prognoses (without transplant.) Mr Wood responded in the WSJ article,

it wasn't until 2006 that the transplant community coalesced around a score of 15 as a cutoff to allocate organs. 'It would be unrealistic to expect a physician to practice according to yet-to-be-discovered criteria,' he said.
Actually, prioritizing liver transplants according to the recipients' MELD scores became the policy of the Organ Procurement and Transplant Network (OPTN) of the United Network for Organ Sharing (UNOS) in 2002. An article documenting the network's experience during the first year of this policy showed that the proportion of patients with mean MELD scores less than 15 ranged from about 5% to 25% across the 11 OPTN regions, with an average of about 15%.(3) This suggested there was a clear consensus to minimize the number of transplants for patients in this most favorable prognosis group by 2002. Sorry, Mr Wood.

Furthermore, yesterday Mr Wood published a letter in the Wall Street Journal in response to its article. In it, he did not provide any specific justification for the aggressive transplant policies that was based on evidence of benefits from these policies. At best, he could say,

As the pioneer and acknowledged leader in transplantation surgery, UPMC is continually exploring and testing new life-saving procedures. The use of expanded criteria organs is an attempt to alleviate a critical nationwide shortage. This alone was a compelling reason for developing a potentially groundbreaking program in living-donor liver transplant, but clearly there are risks involved whenever new procedures are developed.

This completely begged the question of whether the benefits were sufficient to offset the risks.

Furthermore, he noted,

To suggest that medical decisions are made on the basis of revenues and profits is simply ludicrous. Transplantation procedures account for less than 2% of UPMC's $7 billion in annual revenues, a fact the reporter mostly chose to ignore.
One would think an organization boasting "50,000 employees ... [and which] comprises 20 tertiary, specialty, and community hospitals, 400 outpatient sites and doctors’ offices" would pay attention to a mere 200 patients a year which provide 2% of its revenue.

He had to end up with this bit of puffery,

The real story at UPMC -- one that would clearly be of interest and importance to your readers -- is how a small, regional psychiatric hospital in Western Pennsylvania transformed itself into a self-sustaining global health enterprise that provides the highest quality medical care to patients around the world.

The advent of the internet age makes it much easier to see through attempts by health care leaders to "manage the message" (in this case, and usually by proxy) to insulate them from criticism for their actions. Maybe in the near future we can dream of health care in which incentives are made proportional to effort, ability, and most importantly the ratio of benefits to harms provided to patients.

ADDENDUM (26 November, 2008) - We were first alerted by issues with the UPMC liver transplant program in a comment on this Health Care Renewal post.

1. Taioli E, Marsh W. Epidemiological study of survival after liver transplant from a living donor. Transpl Int 2008: 21(10):942-7.

2. Middleton PF, Duffield M, Lynch SV, Padbury RT, House T, Stanton P, et al. Living donor liver transplantation--adult donor outcomes: a systematic review. Liver Transpl 2006; 12(1):24-30.

3. Freeman RB, Wiesner RH, Edwards E, Harper A, Merion R, Wolfe R et al. Results of the first year of the new liver allocation plan. Liver Transpl 2004; 10: 7-15.

Monday, November 24, 2008

Disclosure of a Salesman - GlaxoSmithKline, Dr Frederick Goodwin, and "The Infinite Mind"

[See late addenda at the end of the post.]

Earlier this year, an article by Shannon Brownlee and Jeanne Lenzer, "Stealth Marketers: Are Doctors Shilling for Drug Companies on Public Radio" in Slate discussed how the host and panelists on a segment of the acclaimed radio show, "The Infinite Mind," broadcast on the US National Public Radio network, which minimized concerns about adverse effects of second-generation antidepressants had ties to companies that made such drugs. (See our post here.)

Last week, Gardiner Harris, writing in the New York Times, indicated that the show's host, Dr Frederick Goodwin, had even more extensive financial ties to pharmaceutical companies than were previously known.

An influential psychiatrist who was the host of the popular public radio program 'The Infinite Mind' earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program.

The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first news media figure to be investigated.

Dr. Goodwin’s weekly radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view.

'But as we’ll be hearing today,' Dr. Goodwin told his audience, 'modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.'

That same day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. In all, GlaxoSmithKline paid him more than $329,000 that year for promoting Lamictal, records given to Congressional investigators show.

Even though Dr Goodwin's relationships to GSK were apparently substantial and prolonged, they were certainly not disclosed to listeners of "The Infinite Mind."

In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting but that neither thought 'getting money from drug companies could be an issue.'

'In retrospect, that should have been disclosed,' he said.

But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drugmakers and that, after an article in the online magazine Slate this year pointed out that guests on his program had undisclosed affiliations with drugmakers, he called Dr. Goodwin 'and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, 'No.''

Here we go again. This is yet the latest case in which an influential physician spoke or wrote favorably about drugs or devices without disclosing he was a well-paid consultant for a company that had commercial interests in those very same treatments.

In this case, Dr Goodwin spoke directly to the public, rather than to fellow practitioners or academics. While it may be hard for even trained professionals to detect undisclosed commercial bias in the lectures they attend or the articles they read, it should be even harder for lay-people to detect such bias. Furthermore, Dr Goodwin was broadcasting on National Public Radio, an organization that does not carry advertising, and prides itself in its independence and commitment to education. That reputation may have lulled listeners into even more confidence that what they were hearing was educational, not advertising. Note that Mr Harris wrote,
'The Infinite Mind' has won more than 60 journalism awards over 10 years and bills itself as 'public radio’s most honored and listened to health and science program.' It has more than one million listeners in more than 300 radio markets.

Make that "had listeners," since

Margaret Low Smith, vice president of National Public Radio, said NPR would remove 'The Infinite Mind' from its satellite radio service next week, the earliest date possible. Ms. Smith said that had NPR been aware of Dr. Goodwin’s financial interests, it would not have broadcast the program.

Although we wrote in May that one segment of "The Infinite Mind" seemed to be more about stealth marketing than independent, educational broadcasting, now it appears that what was infinite about this mind was its dedication to marketing rather than education. Is there any space in health care that isn't now permeated by the fog of deception and disinformation?

To begin to restore trust in health care, we must insist on total transparency, starting with full disclosure of all commercial and financial relationships that may influence clinical and health care policy decision making. Disclosing relationships, however, does not reduce their influence, or even make it possible to compensate for it. If physicians want to regain their leadership role in health care, they may have to declare that they will henceforth only serve patients, and, if they are academics, their students and science. As long as physicians work part-time for marketers, they risk being regarded as nothing better than fancy but not particularly honest carnival barkers.

ADDENDUM (24 November, 2008) - See also news coverage on the Pharmalot blog. Also, that blog and Postscript, the Prescription Project blog both discussed an ongoing investigation by Senator Charles Grassley (R - Iowa) into a consulting company called Best Practices LLC, which may have something to do with the "dissemination of 'off-label' information," and of which Dr Goodwin was a "founding consultant."

ADDENDUM (1 December, 2008) - See this segment from the NPR show "On the Media." Also see this post on the Carlat Psychiatry Blog.

ADDENDUM (3 April, 2009) - A correction of and apology for the content of the above segment of "On the Media" indicated that Mr Lichtenstein was in fact unaware of Dr Goodwin's financial arrangments, and that Dr Goodwin had, rather than telling Mr Lichtenstein about these arrangements, omitted disclosure because he did not think the arrangements constituted conflicts of interest.

Open letter to Sen. Baucus on Health IT

Dear Sen. Baucus,

I respectfully offer you the following information in the hope that it will improve your efforts towards healthcare reform, enabling better healthcare for all.

From the WSJ, Nov. 24, 2008:

SEN. BAUCUS: Everybody talks about health IT. We all know we need it. It hasn't happened. Why? Partly because we're America. We're not a single-payer system like the UK, which can say, you hospitals, you have to put this in because we're paying your bills.

Indeed, that was said to the UK's hospitals. It has worked out to date - to put it politely - poorly.

The UK's results to date, after the expenditure of billions of dollars ...

(and an ironic dependence on an American health IT company, Cerner; see "Big Problems Hit Royal Free's Cerner Records Roll-out" and "Milton Keynes' Care Records System Caused Near Meltdown" as examples of how that's been working out)

... are at this healthcare renewal posting and include the following results. This is recommended reading for you, Senator Baucus, and our Congress as well:

Bank bailout puts £12.7bn NHS computer project in jeopardy

John Carvel, social affairs editor
The Guardian, Wednesday October 29 2008

The future of the NHS's £12.7bn computer programme was in doubt last night after its managers acknowledged further delays in introducing a system for the electronic storage and transmission of patients' records.

Connecting for Health, the NHS agency responsible for the world's biggest civil IT project, said it was no longer possible to give a date when hospitals in England will start using the sophisticated software that is required to keep track of patients' medical files.

Christine Connelly, the Department of Health's recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

In May the National Audit Office said the project was running at least four years late, but still appeared to be feasible. It has since been beset by a series of further setbacks.

The agency fired Fujitsu, the contractor responsible for building the patient record system in the south of England. It asked BT to take over the work, but has not yet agreed a price.

In London, attempts to install the system at the Royal Free hospital and Barts caused weeks of confusion and disruption. Other trusts that were next in line were so alarmed that they pleaded for postponement.

In the north, the first installation of the Lorenzo version of the software at Morecambe Bay was repeatedly delayed.

Sanator Baucus, if health IT is "easier" in the UK due to their being single payer, then heaven help the U.S. in such efforts.

You might also read my post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" for much more on this issue.

Back to the WSJ quoting you:

SEN. BAUCUS: But we're America. We're going to find our solution. We need to work with appropriate bodies to develop interoperable standards, then give incentives to providers so they can put the IT systems in.

I dearly wish it were that easy to "put the IT systems in." I dearly wish that standards and incentives were the sole missing links. Unfortunately, the reality is far different, as thirty-plus years of informatics research has shown.

Sen. Baucus, I invite you and your staff to increase your awareness of Biomedical Informatics. In doing so you will learn that the call for "interoperability" of health IT may be setting our sights impractically high, and that what's more needed and attainable is aggregatability of intelligently selected data elements into a national repository.

The repository can then be used as an "executive radar" and is far easier to accomplish (and already has precedents on a smaller scale) then full interoperability among a menagerie of competing HIT products from myriad strong-minded "our way is best" vendors.

As to "incentives", you will also learn from sites such as "Common Examples of Healthcare IT Difficulties" and courses such as "Organizational and Sociological Issues in Health IT" (Word file) that standards and incentives and the fact that we have a heterogeneous healthcare environment are not the major impediments to HIT diffusion.

People issues and leadership by HIT "amateurs" (those lacking formal education and credentials in the subspecialty of clinical computing) trump all other issues, as in any area of technology. You might review the article "Electronic Medical Records - Not for Amateurs" starting on page 21 of the PDF file here.

I fear, however, that Congress subscribes to the procrustean, reactionary, IT industry-enriching, Intel-Craig Barrett "if it works for my horses it will work great for people" belief that clinical computing is just another brand of business computing, and that it's fine to further burden primary care physicians in their fifteen minutes per patient with hard-to-use IT where user interaction design was an afterthought.

The very same IT that may then cause - through overly simplistic, biased or defective P4P formulas and metrics - the diversion of hard-earned money from clinicians' pockets to the payers' purse.

In which case, good luck with a national efforts at HIT.

You and the rest of Congress would need it, as physicians would rightly apply active and passive aggression and other measures to sabotage and sink ill conceived and poorly implemented HIT initiatives led by amateurs.

And if the leadership for a U.S. national health IT initiative remains typical of other flavors of IT, with its high rates of difficulty and failure, I could not condemn U.S. physicians in that regard.

Worse, Sen. Baucus, as per the European Federation for Medical Informatics (EFMI) Working Group for Assessment of Health Information Systems, you should be aware that bad informatics can kill.

Finally, everyone on your staff and in Congress should read this article from Down Under:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).

Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. link to pdf

It tells a cautionary tale to counterbalance the irrational exuberance over IT that seems to have taken hold in our society, indeed paradoxically accelerating after the great dot-com crash of the early 2000's. (My statement on the exuberance issue is webcast at Government Health IT here.)

Senator, I hope this information is useful and enlightening to you, and helps steer a more informed approach to health IT, so that health IT can succeed in its mission to improve healthcare.

It seems self evident that a defective healthcare system cannot itself be reformed or improved via defective health IT.

-- SS

Saturday, November 22, 2008

Man on a Mission

A bit of an impassioned sermon here:

At the very top of the homepage of my academic website "Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Difficulties", it states:

Readers and informatics educators utilizing this site: please let me know how you arrived here and your comments. Additional case examples are also appreciated.

To me, that language appears plain. From time to time, however, I am surprised by those who utilize, reference or critique my website but don't tell me, and of the latter group, offer me the opportunity to respond or even tell me of the critique.

One such example I found via the periodic access patterns survey I perform regarding the site. It is in HIT consultant company Navigant's newsletter of August 16-31, 2008 entitled "Healthcare IT Value Digest" by Douglas Thompson, MBA, FHIMSS at this link (225kb MS-Word document).

Mr. Thompson writes:

HIT Failure Cases: Sociotechnologic Issues in Clinical Computing Illustrated (visit the website)

Man-on-a-mission, Dr. Silverstein writes about an “apparent paradox”…While clinically oriented IT is now potentially capable of achieving many of the claimed benefits (improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth), there is a major caveat and essential precondition: the benefits will be realized only if clinical IT is done well. For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources. “

Dr. Silverstein’s web site is dedicated, not to HIT’s benefits, but to its failures. In a lengthy (and a bit hard to read due to the navigation) front page he delves into the reasons why healthcare IT projects fail to deliver their intended benefits. Several case examples are provided in another section to illustrate the concepts discussed on the first page.

"Man on a Mission", indeed. More on that later.


I'm not sure why the front page is hard to navigate; the only navigation needed is via a scroll bar.

I am puzzled why a statement is made that the site is dedicated to "HIT's failures." In fact, the site is dedicated to eradicating these failures through education about the "worst practices" that commonly negate any "best practices", and a lack of domain specific knowledge among HIT leaders, that contribute substantively to causing the failures.

The newsletter then goes on (see "out take", below) to point the reader to the usual "Master Of The Obvious" best practices sources typical of conventional HIT consultants, i.e., lacking formal biomedical and biomedical informatics education and expertise, but does not point the reader towards the crucial importance of understanding the failures and the reasons for them at a very, very fine grained level that viewing a few videos, going to an annual meeting or retreat, reading a management motivation book once in awhile, or reading a few articles in throwaway journals cannot impart.

In contrast, having worked in the public transit industry (Manager, Medical Programs, Southeastern PA Transportation Authority, late 1980's), I can assure that the National Transportation Safety Board - and NASA for that matter - ensures that causes of accidents are understood down to the last defective nut and bolt and nuances of competence and morale.

Not referenced in the newsletter was the more comprehensive academic literature (for example, see this .xls spreadsheet used in just one Biomedical Informatics course I teach, as well as this PubMed link). Also see informatics texts such as "Medical Informatics 20/20" by the VHA pioneers and "Managing Technological Change: Organizational Aspects of Health Informatics" by the Biomedical Informatics pioneers. Knowing and understanding this literature is one of the reasons for postdoctoral fellowships and master's programs in Biomedical Informatics, I might add.

Here is the consultant's "take" in the newsletter:

Our Take

A growing consensus seems to be emerging that, a.) clinical systems have advanced to the point that they can provide great value, b.) most providers have not figured out how to use them effectively, and c.) there are known solutions to this problem. Dr. Silverstein spends most of his time on a. and b., but The Information Paradox (below) gets into c. (although it’s not healthcare-specific).

We’ve covered these same points in our HCI blog (see an example), and in our recent series of Scottsdale Institute teleconferences (audio files accessible by members on the SI website, let me know if you want a copy of the slides).

July 10 - Clinical System Benefits-Driven Implementation: Lessons Learned from Early Adopters - How to manage a clinical system implementation “to the benefits,” instead of “to the technology.”

August 13 - Clinical System Benefit Measurement Metrics: How to Select, Collect and Report - A detailed “technical” discussion laying out the principles of benefit metric selection, issues around data collection, principles of report design and use; and illustrating them with real-world examples.

October 2 - Clinical System Benefit Requirements: A Practical Tool for Benefits-Driven System Implementation - Practical examples of how to identify and use detailed technical and process change requirements focused on realization of specific operational benefits, as distinguished from a focus on process changes or technical implementation goals.

Note point b) above: "most providers have not figured out how to use them [clinical systems] effectively." Typical blame the clinician statement typical of the HIT vendor/consulting conclave; nothing is mentioned about problems caused by other stakeholders - such as - business IT personnel ... or healthcare executives with their own territorial issues and agendas.

I would've recommended moving point "c" above to "d" and stated a new "c" along these lines (if I'd been given the opportunity, that is):

c) Most business IT personnel have not figured out how to apply true best practices known from decades of medical informatics, social informatics and IT management research in complex clinical settings, and perhaps more importantly, how to avoid permitting "worst practices" of various stakeholders to nullify the benefits of any best practices that might be employed."

My site focuses on the importance of making readers aware of the latter issue.

Point "d" would then have been "there are known solutions to these problems" (plural).

Man on a Mission:

That said, I want to focus on the "Man on a Mission" statement. I'm not sure what "mission" Mr. Thompson was referring to. I will, however, elucidate what I believe is my mission in clear terms. My "mission" can be stated as:

"To eradicate HIT mismanagement, often due to lack of biomedical and biomedical informatics domain knowledge, that compromise the core values of medicine and increase risk of patient harm by ill conceived and poorly implemented HIT."

I think that's reasonably clear.

I would also like to elucidate the reason for my "mission."

In residency training, I spent many months in CCU's and ICU's at Abington Memorial Hospital near Philadelphia. During that time, I gave of my time freely, often going above and beyond the call of duty to ensure the very sick patients had the best chances of survival and the least chances of death.

Some examples:

On an evening after I'd already been on call and had worked perhaps 32 hours straight with just a few hours of shut eye here and there, a true blizzard was forecast. I slept at the hospital overnight, believing it would be hard for anyone to get in the next morning, and in fact after a huge blizzard, almost nobody could. I made early rounds in the ICU that morning, ensuring critical patient needs were met without fail.

Along with then-intern Dr. Lindsey S., we once managed three near simultaneous cardiac arrests in the ICU's during family visiting hours, with a Mennonite minister-in-training in tow who remarked how amazed he was at how physicians could keep their composure and do what needed to be done under such conditions.

On another date I was handed the phone by a nurse to speak to then-intern Dr. Alan T., just minutes after I ran a prolonged, unsuccessful resuscitation effort on his mother, an ICU patient, and then declared his mother deceased. The ink was barely dry on the death certificate. Alan then called in -- from a funeral parlor just before his father's funeral.

Alan's father, a healthy ophthalmologist, had passed away in the CCU next door the prior day and he was calling in from the funeral parlor to find out how his mother was.

His father had suffered a massive MI (heart attack) a week before, probably in part due to the stress of his wife being gravely ill and in an ICU from rapidly progressive colon cancer and chemo complications. They spent the last days of their lives as neighbors, mother in ICU and father next door in CCU.

I did not think it wise to tell Alan what had happened to his mother via phone, and made a tough and what I considered merciful decision and said "no change." He only found out later what had transpired when he was with us in the hospital, where I felt we could attend to his possible needs better. I several years later wrote Alan a recommendation letter that helped him secure a fellowship in ophthalmology.

Another intern and I once spent much of a night repeatedly using the paddles on a man whose heart kept going into ventricular fibrillation after a heart attack. We had to resuscitate him more than a dozen times. He then was transported for emergency surgery at Temple to remove the unstable area of heart tissue the next day, as soon as he was minimally stable. He thanked us for our heroic efforts after his recovery - his recovery from dying over a dozen times and being brought back to life by very, very determined CCU doctors - us.

This is what goes on in an ICU. That is what doctors do. That is what we train for.

Now, consider the following story several years later, after my training in Biomedical Informatics:

As a Director of Medical Informatics in a large hospital I encountered apparent endangerment of ICU patients from inappropriate, dust-laden, air-circulating, business class computers subject to bacterial colonization that were mounted on the ceilings above each ICU bed. They were malfunctioning as well due to a system architecture inappropriate for mission critical settings. My advice on changes to more appropriate hardware and other measures to ensure patient safety were simply overruled by IT personnel.

My counsel was overruled and ignored by the IT staff and CIO on grounds that the IT staff were unfamiliar with existing, ICU-appropriate computer hardware and wouldn't support or even evaluate "nonstandard" (to them) computers in any case. Patients remained at risk. Having spent much time in medical and cardiac ICUs during my residency and having done what it takes to provide the very best of care to extremely ill patients with little consideration for my own convenience, I found this experience rather remarkable and, in fact, shocking. This experience informed the first case example of health IT dysfunction at my HIT difficulties website.

Read that story, entitled simply:

"Serious clinical computing problems in the worst of places: an ICU"

located at this link.

Read it carefully.

I have never received any feedback on this story. Ever. It's almost as if this scenario causes nobody any concern. Nonchalant. So what. Who cares?

I cared.

Try to imagine, after my own ICU experiences, my horror at the rape of medicine's core values by arrogantly ignorant, mediocre, non-clinical IT personnel, hospital administrators, cavalier HIT vendors, and even complacent physicians who disparaged doctors who left practice for informatics and who opined that "they did not believe it is a sine qua non that a physician be at the helm of the clinical informatics enterprise."

I refer to the core values of medicine I learned from "Mad Genius of Broad Street" cardiothoracic surgery pioneer Victor P. Satinsky, MD in summer NSF programs at Hahnemann Hospital as a high school student - "critical thinking always, or your patient's dead" and "if you don't like it [the hard work and rigor needed in medicine], don't come" - and during four grueling years of medical school, and four years of sometimes 80-90 hour residency workweeks, with equally grueling ICU rotations where I gave of myself without thought of individual inconvenience.

Imagine my abject horror watching patients put in harm's way by defective computing while being able to do nothing, despite a title of "Director of Clinical Informatics" (which even today usually means "director of nothing"). Imagine the sheer lunacy of being insulted and marginalized by politically powerful non clinical IT personnel, itself a bizarre phenomenon in hospitals, for efforts to protect seriously ill ICU patients. Imagine the pathology of milquetoast reactions by linguini spined administration who'd rather "everyone got along" (thus maintaining the country club atmosphere of their highly paid jobs) than take reasonable and firm action to protect the most vulnerable of patients.

This was the stuff of nightmares.

Yet I saw these same patterns of HIT mismanagement over and over, in numerous medical organizations, in the years since. I have heard similar stories from colleagues not just in the U.S., but in other countries as well, who found my website on searches for such information.

Give it one minute of deep, critical thought. Leave the bovine stare of incomprehension, the ostrich's head in sand reaction, the namby-pamby "let's all be nice to one another and not air the dirty laundry" drivel behind for just one damn minute.

If you can.

Imagine your mother, or your father, or yourself as a patient in that ICU with a defective computer system hanging over your head, colonized by infectious pathogens for the convenience of IT personnel.

That's all I ask. One minute of clarity.

If you do so, the reason for my "mission" should be very, very clear.

-- SS

Final note: I have passed a link to this story to Navigant consultant Mr. Thompson.

Wednesday, November 19, 2008

Look Who's In The Operating Room

At an article today entitled "Medtronic Says Device for Spine Faces Probe" (Wall St. Journal, Nov. 19, 2008, subscription required) the WSJ reports another major medical device manufacturer, Medtronic, faces a probe for promoting unapproved uses of its technologies, which is improper:

Doctors can deploy FDA-approved drugs and products any way they see fit, but companies aren't permitted to promote off-label applications or to pay doctors inducements to do so.

"While the law establishes that doctors can prescribe any approved treatment, but off-label promotion by manufacturers is not allowed, there's growing concern that the line is being crossed, and a Justice Department review is the right kind of response to those questions," said Sen. Charles Grassley (R., Iowa) who has been looking into whether inducements by Medtronic have led doctors to use its products off-label.

This type of story is common at Healthcare Renewal, and the blog leaves quite a rich trail of search engine-available information, since the healthcare blogs are relatively immune to the anechoic effect. I see numerous hits from governmental agencies in the U.S. and overseas, for example, on search engine queries regarding malfeasance or incompetence at specific companies and organizations. I will not comment on the ethics of the Medtronic/nonapproved promotion issue any further here.

I do want to comment, however, on an item in the WSJ article that caught my eye:

Depositions in a malpractice lawsuit brought by Laurie DeNeui, of Rushmore, Minn., focused on off-label Infuse use and Medtronic salesman Curt Messler's relationship to her spinal surgeon, Bryan J. Wellman of Sioux Falls, S.D. Mr. Messler said in his depositions in the case that he was with Dr. Wellman in the operating room "a lot" when he used Infuse. He also said he considered Dr. Wellman a friend and said the men saw each other socially.

... About four days after her October 2005 operation to fuse cervical vertebrae, Ms. DeNeui said in an interview, her neck swelled up, she had trouble swallowing and she started choking on food. Soon, she said, she started having difficulty breathing. Ms, DeNeui, 46, said the problems prevented her from returning to work as a teacher and baffled several specialists. Steroid treatment helped ease the breathing and gagging problems, but caused her to gain weight and contract diabetes.

Dr. Wellman denies any malpractice. In a deposition, he said Mr. Messler encouraged him to use Infuse in cervical spine operations, and that he has done more than 100 such procedures with the product. Dr. Wellman said he discussed with Mr. Messler the right dosage of the Infuse material to use in the surgeries but determined the dosage on his own.

Mr. Messler, who isn't a physician, has a degree in criminal justice, and his prior work history included owning a bar and jobs with New York Life Insurance Co. and Procter & Gamble Co. In his depositions, Mr. Messler denied encouraging Dr. Wellman to use Infuse for unapproved applications or discussing how much to use.

This is the typical I said-he said scenario. That issue's adjudication will also not be discussed here. While the article also states this patient signed a consent to permit Medtronic representatives to be in the operating room, I have several questions of a very fundamental nature.

In background to these questions, when I was fifteen years old I attended the summer NSF-funded Advanced Preceptorship Training Program (ATP) at Hahnemann Medical College and Hospital back in the early 1970's. It was a program designed to introduce high school students to biomedicine (ironically Hahnemann's former medical college is now part of Drexel University, where I teach healthcare informatics). I was assigned back then to watch surgery under the surgical team of Drs. Pearce, Ulin and Weinstein, permitted to scrub in and hold retractors, and in one case to actually saw through a femur in a leg amputation for diabetes-related gangrene. I also made rounds with the surgical team. While today this practice would probably not be permitted on privacy and malpractice concerns, I can honesty admit I offered no advice on surgical procedures or other interventions. I simply didn't have the background.

In the Medtronics situation of reps in the O.R., I thus ask the following questions:

  • Were patients and others in the O.R. aware of the lack of the Medtronic sales representative's medical credentials?
  • Are such consents sought and signed routinely for allowance of medical device company reps in the operating theater?
  • What, exactly, was the purpose of having a nonmedical person in the O.R.? What, exactly, could such a person contribute?
  • Why would any patient want a nonmedical person in the O.R. with the potential for that person to give advice or affect the procedure in some manner?
  • What were patients told to convince them to sign the consent?
  • If advice was given of any kind to any clinician the O.R., would that not constitute the practice of medicine without a license?
  • What were the rep's obligations if they witnessed anything they thought could be misuse of the device, or any other practice they thought improper?
  • Did the rep follow the surgical team around in postop care?
  • Why couldn't Medtronic actually hire people with medical backgrounds for such roles, instead of a former bar owner and P&G sales rep? Could such people be afforded?
  • Might people with medical credentials and experience actually be better suited to make valid scientific observations in the O.R. setting?

These are just some of the questions that come to mind in the seemingly inexhaustible cornucopia of nonmedical people either leading healthcare organizations or performing roles perhaps better performed by people who actually have a medical background, and actually know at a very detailed level what they're doing.

-- SS

Politician, Medical School Dean Convicted in Connection with Bribery and Fraud at UMDNJ

We have frequently discussed the plight of the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest health care university in the US. Facing indictment for federal crimes, the university operated under a deferred prosecution agreement and the supervision of a federal monitor from 2005 to 2007. We most recently blogged about UMDNJ here, and see links backward to previous posts from here.

As reported by the Newark Star-Ledger, there have just been criminal convictions in two cases related to the scandals at UMDNJ:

Former senator Wayne R. Bryant was found guilty yesterday of selling his office as one of New Jersey's most influential lawmakers for a medical school job that padded his pension, in a case that also put on trial the secret political horse-trading of the state budget process.

A federal jury in Trenton convicted Bryant of bribery for soliciting a job at the School of Osteopathic Medicine in Camden County and using his influence to help the school acquire $10.5 million in state grants between 2003 and 2006.

The jury also found Bryant, 61, of Lawnside, guilty of 11 counts of mail and wire fraud stemming from the scheme to land the $35,000-a-year 'low-work' job at the school, run by the University of Medicine and Dentistry of New Jersey. Prosecutors said Bryant used the mail to apply for the job, get paid, and file a financial disclosure form for 2003 that omitted his UMDNJ job -- all in an effort to defraud the state Division of Pensions and Benefits.

'The brazen arrogance of Wayne Bryant -- to believe that he was completely beyond the reach of the law, to extort state institutions for personal profit in return for the funding of good and worthwhile programs that serve the poor, the disadvantaged and the needy of our state -- is simply the most disgusting conduct I've seen by a public official in my seven years as U.S. attorney,' [US Attorney Christopher J] Christie said.

The jurors, who deliberated 14 hours over three days, also convicted the medical school's former dean R. Michael Gallagher, formerly of Haddonfield, of bribery for hiring Bryant to perform what prosecutors say was a phony community relations job. Gallagher also was found guilty on five of the six mail and wire fraud charges involved with creating the job.

The ex-senator and the ex-dean each face more than 15 years in prison when they are sentenced March 20, according to the U.S. Attorney's Office.

The relationship between Bryant and UMDNJ was perhaps made a bit more clear by the Philadelphia Inquirer's version of the story:

In late 2002, Bryant solicited a job from Stuart Cook, then president of the public University of Medicine and Dentistry of New Jersey (UMDNJ). Prosecutors termed it a 'shakedown.'

Gallagher, the former dean of the School of Osteopathic Medicine in Stratford, then rigged a hiring process to give Bryant a job. The school is one of UMDNJ's campuses.

During the years of his employment, from 2003 to 2006, Bryant steered $10.5 million to the osteopathic school, and lobbied on its behalf in other matters.

Prosecutors noted that he had done nothing to help the school before going on its payroll.

Bryant was paid a $35,000 salary and given a $5,000 bonus one year. This, prosecutors said, despite the fact that he showed up on campus just one morning a week and spent most of his time there reading the newspaper and talking on the phone.

These were not the first findings of guilt in the UMDNJ case. Earlier this year, as we noted here, two UMDNJ cardiologists pleaded guilty of embezzlement in a scheme in which they were paid for academic work they did not do in exchange for referring patients to UMDNJ. However, by that time, nobody in a leadership position in UMDNJ had been charged, much less convicted of a crime in connection with the scandal. Now at least one former UMDNJ official has been convicted.

In a continued and striking demonstration of the anechoic effect, the UMDNJ case up to now has never graced the pages of any medical, health care research, or health care policy journal. I wonder whether the convictions of a prominent politician and a former osteopathic school dean will be enough to get this dramatic and sordid case noticed in the medical and health care literature. One would think that a large health care university forced to operate under a federal deferred prosecution agreement, under the supervision of a federal monitor, would have sufficient implications about problems in the leadership and governance of health care organizations to gain widespread attention.

However, as long as such cases are reported as merely regional aberrations, physicians, other health care professionals and patients will probably continue to believe that the ethical challenges they may witness are merely local misfortunes. Until we all recognize that the problems are widespread, if not global, we will not be moved to action. And maybe that is why there is such pressure not to discuss the wider implications of local problems, or to discuss how similar all the local problems are.

For discussion of many other cases of poor leadership and governance of health care organizations, please peruse the archives of Health Care Renewal.

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


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

Tuesday, November 18, 2008

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."