Monday, July 31, 2006

The High "Cost of Courage" in the UK

A while ago, the Pittsburgh Post-Gazette published a series called The Cost of Courage about physicians threatened with punishment or who lost their jobs because they complained about quality problems at their hospitals.

Now there is a UK version of this. The Guardian just reported that Dr Otto Chan, at the Barts and the London NHS Trust, was fired after he complained about a huge backlog of unread x-ray films.

from 2000 the number of films started to accumulate in the Royal London. 'At first it was just few packets from outpatients and inpatients but gradually they built up. By 2001, it was 10,000 packets of film (each packet contains up to eight images) and by 2002, it was up to 15,000 packets. They were stuffed into boxes and kept in the corridor.

'One day I turned up and they had all disappeared. I tracked them down to a storeroom which had been locked, and it transpired that the inspectors from the Commission for Health Improvement [now the Healthcare commission] were coming round on a visit.' Managers at the time said that the move was taken to protect safety of patient records.

These films were finally read at the end of 2002 after Chan demanded action, and threatened to go public with it. But the hospital administration then allowed a second backlog of another 15,000 packets of film to build up between 2003 and 2004. This time, there was no agreement to read all of them. Apart from chest X-rays the second pile of films was never checked by radiologists.
Dr Chan, 49 and a father of six, was suspended 18 months ago, and then dismissed last month - a decision he is now fighting. 'I believe I was sacked because I was marked out as a whistleblower and a troublemaker, and that's because I refused to accept that thousand of films lying jumbled up in a corridor constituted good patient care,' he said.

In January 2005, Chan was suspended and accused of professional misconduct. The trust, under threat of legal proceedings from Chan, appointed an internal investigation panel headed by a QC which took 12 days of evidence about the saga, and which included other doctors' accounts of the piles of films. The findings of the panel remain confidential but it is understood that in April this year, they concluded that although there were 'serious deficiencies' in his behaviour towards managers, he had made a 'very substantial contribution' to the trust, and they should consider re-employing him under a different structure.

Chan was therefore shocked to be told on 7 June that he was 'summarily dismissed'.
Amazingly, a hospital leader seemed to admit the existence of the x-ray backlog, and that many x-rays were never read.
In a statement last night, Dr Charles Gutteridge, medical director of the trust, said: 'It is true that at times in the past our radiology service experienced considerable pressure, due to the volume of films and a national shortage of qualified radiologists and radiographers. It should be emphasised that the images concerned were from patients with the lowest clinical risk. Patients with the highest clinical risk have always been reported urgently.'
He denied that Chan was fired because of his whistle-blowing:

The panel concluded that there were grounds for dismissal. The dismissal was in no way connected with issues with our radiology processes in the past.
However, the Mirror reported that Chan
was accused of bullying and racism towards his junior doctors but colleagues said that far from being a bully, Dr Chan was 'a delight to work with'. One said: 'It's an utter disgrace. The public are being deprived of a doctor who can help save lives. His skills are irreplaceable.'
Furthermore, the Guardian noted
Charles Blakeney, a radiologist at the Royal London who worked for years with Chan, said: 'The way in which he [Chan] has been victimised is to my mind, disgraceful. He raised the issue of the unread films because it mattered to him that patient safety was being compromised. I was shocked beyond belief, as were many others, when he was dismissed.'
And it gets considerably worse. The Mirror reported that the practice of suspending UK doctors and nurses who questioned management or complained about quality is widespread. A spokeswoman for a nurses' group, Campaign Against Unnecessary Suspensions and Exclusions, charged, "People are being excluded on the basis of unsubstantiated allegations and often within days of them highlighting an area that could cause embarrassment. Put simply, it's the quickest and easiest way to get whistleblowers to shut up."

Examples cited by the Mirror included,
One senior consultant was sent home for 'not being a team player' and a radiologist for 'an unauthorised audit'.

And increasing numbers of staff claim they are suspended for raising concerns about poor practice or patient safety.

Some doctors and nurses claim they have been banned from work just because of personality clashes with their managers.

They are forced to stay at home while trusts conduct investigations into alleged offences such as 'bullying' or 'harassment'.

A highly qualified mental care nurse claims she has been excluded for more than two years for raising concerns about the safety of elderly patients. Another nurse has been suspended for nearly six months after she complained of being sexually harassed by a lesbian senior colleague.
It seems that the "cost of courage" in the UK is as high as it is in the US. Furthermore, some in the UK seem to have borrowed the tactics frequently employed by academic administrators in the US, accusing those who question their leadership of politically correct charges such as "bullying," "harassment," or "racism." (See the FIRE web-site, and the ACTA online blog for other US academic examples.)

Quality health care will not long survive such a totalitarian mind-set on the part of its organizational leaders.

"Repositioning and Rebranding" While UMDNJ Burns (Money)

The management of the University of Medicine and Dentistry of New Jersey (UMDNJ) was back in the harsh media spotlight again. UMDNJ has appeared frequently in posts on this blog. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see recent posts here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See post here, with links to previous posts.) Most recently, the costs of all these management shenanigans was estimated to be a whopping $243 million (see post here).

The indefatigable Newark Star-Ledger reported that yet another UMDNJ trustee has resigned. This time the issue was
the federal monitor overseeing the school concluded [trustee] Sterritt had committed ethical and legal violations by pressuring university officials to hire his brother, an admitted alcoholic who lost his license to practice law because of misconduct.

The monitor, former federal Judge Herbert J. Stern, said in the report that staffers within the university's human resources department complained that Sterritt was 'very involved' and 'persistent' in an effort to find his brother a position at UMDNJ -- which they considered unprofessional and unacceptable interference.

The report said UMDNJ staff felt pressure to find employment for Sterritt's brother 'at all costs,' noting he was eventually hired after the job requirements were loosened so he could qualify. However, he was paid at the higher salary of the titled position before it was downgraded, according to the monitor.
The article also cataloged all the other UMDNJ leaders who have left:
In the past eight months, the university has lost its president, who was pressured to leave by Corzine; three other trustees who left after tougher ethics rules were put in place banning even casual business relationships with the school; the dean of the university's School of Osteopathic Medicine and the university's senior vice president for academic affairs, who were both accused of abusing travel and expense accounts; and a senior associate dean, who was fired for abusing his position to help himself, friends and family -- including wielding his influence to get a daughter into medical school.
Meanwhile, the repurcussions of the university's huge financial losses continue. The Star-Ledger also reported that the university will lay off more than 100 staff, raise tuition at the medical and dental schools by four percent, and delay the opening of a new out-patient cancer center at the Newark campus. The interim president warned of "longer waits in the hospital's emergency room for non-critical cases. He predicted patients also will have to wait longer to get appointments at the hospital's clinics, as well as face delays for elective surgery."

But amazingly, despite these cuts, the Star-Ledger further reported that UMDNJ leadership had planned to spend about $2.5 million on a "marketing campaign to spruce up the image of the state's scandal-plagued medical university." This was "the second time the governor's office has killed an image campaign by UMDNJ that it found to be ill-timed or ill-conceived. An earlier media effort was quashed in January under pressure by then-Gov. Richard Codey." (See post here.) " The new plan was to resurrect elements of that plan, in a so-called 'repositioning and rebranding campaign' to highlight UMDNJ's research, aimed at attracting researchers, students and patients to the university's clinical services and its teaching hospital. It included many of the television commercials and print advertisements that had already been produced before the lid had been put on the original marketing effort, officials said." The plan was all set to go forward, but after the Star-Ledger asked the state governor's office to comment on it, "the university was ordered to put the ad campaign on hold indefinitely. That request was made by Stuart Rabner, the governor's chief counsel, who told the university that while image improvement was important for UMDNJ, the $2.5 million expenditure would seem inappropriate at a time when the university was cutting jobs and programs to help address a $25.5 million budget deficit at UMDNJ's University Hospital. "

Ok, UMDNJ is operating under a deferred prosecution agreement, has lost $243 million to mismanagement and other administrative misadventures, has seen the departure of many of its top leaders, is running a deficit and forced to make severe cutbacks. So how do the current leaders respond? - by trying to run a marketing campaign of "repositioning and rebranding?" Is there no problem that can't be papered over by a little repositioning and rebranding?

One correspondent responded to the problems at one of the large pharmaceutical companies by wondering if that company had become "a marketing company that happens to make drugs." Has UMDNJ become "a marketing company that happens to be a health care university?"

Once again, the problem appears to be corporate culture. Health care organizations have attracted leaders who are more interested in marketing than in their fundamental missions. UMDNJ needs leaders who put mission before marketing. Leaders' papering over problems is what lead the university to its current sorry state.

An Issue of "Corporate Culture?" - FBI Raids Bristol-Myers-Squibb

The pharmaceutical company Bristol-Myers-Squibb has been the subject of a few previous posts on Health Care Renewal.

The company is currently operating under a deferred prosecution agreement arising from federal charges that BMS inflated sales figures reported to investors (see post here). We also posted about the games that may have been played with data on the company's new drug for diabetes, muraglitazar.

Now, as reported in the New York Times (and elsewhere), the company is the subject of a new criminal investigation "into a proposed patent settlement involving the company’s biggest-selling product, the blood-thinning medication Plavix. Bristol-Myers markets the drug with the French company Sanofi-Aventis. Yesterday, a coalition of 56 state and territorial attorneys general rejected a proposed settlement, which was supposed to have ended the patent dispute with Apotex, a Canadian company that wants to market a generic copy of Plavix." The day before, the Times reported that "federal agents, armed with subpoenas, searched two offices Wednesday at the headquarters of Bristol-Myers on Park Avenue in Manhattan, including the office of the chief executive, Peter R. Dolan." The questionable aspect of the settlement appears to involve "a payment to Apotex and an agreement that the company not sell its generic version until September 2011, eight months before the United States patent for Plavix was set to expire."

[We posted about questions surrounding clinical studies of Sanofi-Aventis' antibiotic Ketek here. Apotex is the Canadian generic pharmaceutical manufacturer accused of trying to discredit University of Toronto researcher Dr Nancy Olivieri after she voiced her concerns about the adverse effects of its drug defiripone (see post here).]

The FBI raid did not seem to worry the chair of the BMS board of directors, James D Robinson III: “Peter has done a superb job in turning around the company, from developing a new management team, to a pipeline considered to be one of the best in the industry, to the recent approvals which bring innovative new medicines to patients in need,” he said. “He has the full and complete confidence of the board. We believe the actions of all Bristol-Myers Squibb employees, including Peter, involved in this matter have been appropriate, and have been coordinated hand-in-hand with senior outside counsel at every step.”

On the other hand,
Critics of the company’s management and board have said that the latest criminal investigation indicates that the corporate culture of Bristol-Myers has not changed since it was accused of a practice called channel stuffing that involves inflating sales through inventory manipulation, forcing Mr. Dolan to restate earnings by $2.5 billion for the period 1999 to 2001.

Thomas Dubbs, a Manhattan lawyer who sued the company over an aborted drug called Vanlev, called the newest investigation, 'yet another example of the Bristol-Myers board apparently being asleep at the switch.' [Editorial note: despite the fact that the BMS board includes Harvard Professors of Medicine and Public Health, and of Molecular and Cell Biology.]

'One would think that after channel stuffing and the Vanlev debacles,' Mr. Dubbs said, 'they would be paying more attention to whether senior management is playing by the rules.'

The lawsuit by Mr. Dubbs, which the company settled this year for $185 million, contended that Bristol-Myers made unduly rosy statements about Vanlev, a drug for high blood pressure, stirring investor interest in the company even though officials knew it caused a dangerous swelling condition called angioedema.
Given just how often some big health care organizations find themselves splashed across newspaper pages for one questionable practice after another, and now how often organizations that have gotten noticed for the wrong reasons find themselves linked to each other, the issue of corporate culture becomes particularly acute. How many bad headlines in the business sections will it take to get these cultures to change? And when will the stories in the business sections finally leak into the medical and health care press, so that physicians will realize what sort of organizations they must work with?

Saturday, July 29, 2006

Pfizer brings life to my "If you've run McDonald's, you can run anything" metaphor!

In describing the absurd belief within executive circles (probably originating in the b-schools) that domain expertise is optional even in highly sophisticated and specialized industries such as biomedicine, I have used the derisive metaphor "They believe if you've run McDonald's, you can run anything..."

Pfizer has now brought my metaphor to life:

A Long Shot Becomes Pfizer's Latest Chief Executive

In an abrupt move yesterday, Pfizer named its general counsel, Jeffrey B. Kindler, as chief executive, succeeding Henry A. McKinnell, who had been expected to resign in February 2008 ... Analysts and investors had viewed Mr. Kindler, 51, as a long shot for the job at Pfizer, the world’s largest drug maker. Unlike the other candidates, who are longtime employees, Mr. Kindler came to Pfizer four years ago from McDonald’s, the restaurant chain, and has no other pharmaceutical industry experience. He served as general counsel at McDonald’s and was president of the company’s smaller brands, like Boston Market.

So, it has been decided that a lawyer (see also: no science or biomedical background) who ran fast food emporiums will now run a huge multinational pharma company. I'm not sure whether I should laugh or cry.

I do wish Pfizer and its stockholders the best of luck, after watching another non-scientist take another pharma company from the heights of scientist-led glory to where it is today.

It's not all bad, however. It is possible that Pfizer employees will be the beneficiaries of better, tastier chicken and hamburgers in the corporate cafeterias.

-- SS

Thursday, July 27, 2006

Anatomy of healthcare IT failure

A stunning story appeared in a California newspaper that is the poster-perfect example of health IT failure and dysfunction, entitled "Hospital vexed by new computer system." Perhaps it should be entitled "Hospital Hexed by Clueless Executives"...

El Camino Hospital's new computerized record system has been off to a rocky start since its launch in March.

Its first few months at El Camino have seen a state investigation, pharmacy errors, dissatisfaction among physicians and nurses, and the departure of the hospital's chief information officer.

Ironically, this hospital was a pioneer in the early days of clinical information technology. Now, this particular project has the appearance of a train wreck in progress worthy of addition to my site on health IT failure:

... ECHO, which stands for El Camino Hospital Online, is the new system that replaced a medical information system that had been in place since 1971. Doctors and nurses must use it daily in the hospital to place orders for medicines and tests, and to track patient records. Eclipsys Corporation created the ECHO software, which cost El Camino $8 million. The transition has been riddled with errors, however, causing the hospital to bring in an outside pharmacy management company, Cardinal Health.

"We've had some issues in the pharmacy, which is one of the reasons Cardinal Health was brought in," said hospital spokesman Jon Friedenberg, adding, "Issues thatpredated ECHO made the ECHO implementation that much more challenging."

Meanwhile, the Centers for Medicare and Medicaid Services, or CMS, received a complaint that prompted a state Department of Health Services survey on May 19 to investigate. "The condition found [to be] unmet was pharmaceutical services," said Mary Frances Colvin, nurse consultant for CMS.

Friedenberg said pharmacy problems were related to "medication order verification and audit," but that the new computer system was not entirely to blame for lost pharmacy order records. The Voice has requested full survey results from CMS, which were not available by press time. El Camino Hospital submitted the required plan of correction to CMS on June 21, and because the survey revealed problematic findings, Health Services will conduct a follow-up investigation by early August.

Some of the people involved have mentioned that what did not appear in the article is that in addition to having spent $8M on the system in the first place, the problems with the new Eclipsys pharmacy system at El Camino are so substantial that the organization has been losing millions of dollars per month directly attributable to problems in the new system. While I don't know if this is true, it would not surprise me.

The article continues:

Some argue that dissatisfaction with ECHO can be chalked up to doctors and nurses experiencing an adjustment period while learning the new technology. But others say both the errors and general unhappiness could have been prevented with more training before ECHO's launch.

Someone else with knowledge of these events writes:

... when the CIO gave a presentation to the board of directors on ECHO's launch, he gave no hints that there were major problems with it. It was the opposite--he only talked about the how great it was going, and brought in doctors who would say the same. The administration felt it was normal for doctors and nurses to respond overwhelmingly negatively to the new system, but didn't provide ample training to try to prevent a lot of that unhappiness. Plus, the system itself had its problems, particularly with the pharmacy, so overall it was a bumpy transition and to top it off, the CIO left the hospital pretty much right after launching the system.

Also from the article:

... Prior to ECHO's introduction earlier this year, physicians were told through a December hospital newsletter that the new computer system would allow them to "be able to do the same functions from the old system, but in a much easier and more intuitive way." This was not the case for many at El Camino, who found the new system to be unwieldy and not user-friendly, and voiced their grievances through a grass-roots survey of doctor and nurses. "When I go over [to the hospital], I can't even find my patient in the computer system," said Larry Epstein, an internist at El Camino. "It's not intuitive."

CIO's plugging "great systems" to Boards, failing to mention problems that clinicians and patients will have to deal with (like counterintuitive and user-unfriendly design and inability to find patients), exemplifies my line about "hospital IT personnel believing that clinicians toil in hospitals so IT people can have great computers and cozy jobs."

Administration felt it was "normal" for clinicians to respond overwhelmingly negatively and neglected training? That is simply stunning if true, especially in 2006. Resources exist on how to handle these issues proactively. Lorenzi & Riley's book "Managing Technological Change: Organizational Aspects of Health Informatics" is but one example.

That executives in healthcare and health IT may have been fatalistically resigned to "clinician opposition" as a given is another significant problem if true. It's another example of a defective organizational culture that leaps before it looks without doing proper due diligence. In other words, it was negligence. Even a simple google search might have led to resources that could have prevented these problems from occurring.

This new case of health IT difficulty makes me increasingly concerned that the existence of resources like AMIA, its 10x10 education program with the goal of creating a cadre of health care professionals (physicians, nurses, and others) versed in informatics to assist with the implementation, use, and success of clinical IT systems, books like Lorenzi/Riley's Organizational Issues in Health Informatics (first released in 1995) and other resources are still ignored or considered "esoteric" by major healthcare systems and management consultants. At a time when hospital money is scarce, especially with regards to costly clinical IT misadventures, this is not a good sign.

Here's a tough question: what might some good reasons be why executives in expensive failures such as this should not be called on to resign?

-- SS

Bill, have you lost your mind?

In perhaps the most bizarre story about Healthcare IT I've seen in some time, this story appeared in the New York Times:

July 26, 2006
Microsoft to Offer Health Care Software

Microsoft plans to offer software tailored for the health care industry, a change from its usual strategy of encouraging others to create industry-specific products using its operating system and programming tools.

One reason I consider this bizarre is in the apparent "superhuman leap of information technology hubris" I see in the details, by a technology company with core expertise in business-infrastructure software believing it is a "small step for mankind" to move to the bedside. This does not augur well for hospitals' limited resources and capital for clinical IT misadventures:

The company’s first step, announced today is to purchase clinical health care software developed by doctors and researchers at a nonprofit hospital in Washington. Microsoft is also hiring two of the three doctors who created the software system and 40 members of the development team at Washington Hospital Center. ... “This represents a change in our strategy,” said Peter Neupert, Microsoft’s vice president for health strategy. “This is the start for Microsoft. We’re just getting started.”

This is certainly a peculiar way to start. It appears what Microsoft has purchased is a fancy interface engine/display system developed in-house at one medical center, most likely without thought of portability, scaleability, and other critical enterprise issues, in a plan to compete with vendors of similar, field-proven products from health IT vendors with decades of experience. (As an aside, the fact that Microsoft has hired the whole development team raised the question in my mind as to if that team fled, considering my disappointment in the informatics strategic thinking, abilities and insights of former colleagues who are now at the Washington Hospital Center). In any case, how could Microsoft have gone down this route as a "start" in the clinical IT market? Read on:

The Microsoft model in the past has been to supply operating systems, database software and programming tools that outside companies use to make applications for specific industries. The idea is that Microsoft provides the underlying technology platform, but then industry partners build the applications for industries like health care and banking.

Mr. Neupert, 50, is leading Microsoft’s new strategy in health care. In 1998, after 11 years at Microsoft, he left to become chief executive of, an online retailer of pharmacy and health products. From 2003 to 2005, Mr. Neupert ... was co-chairman of a health technology subcommittee that published a report called “Revolutionizing Health Care Through Information Technology.”

Mr. Neupert returned to Microsoft last September, after persuading Steven A. Ballmer, the chief executive, and Craig Mundie, a senior strategy executive, that Microsoft should be doing more in the health care sector.

“I’ve had an opportunity to see how messed up the health care system was,” Mr. Neupert explained. “And to really have an impact, you need a footprint like Microsoft’s.”

(A "footprint like Microsoft's?" Does the "Bull in a China Shop" metaphor seem appropriate here? )

This story in many respects reflects familiar patterns. Notable is that strategy leadership in this initiative is apparently by a person whose healthcare background seems limited to having been CEO of I've also heard the promise of "Revolutionizing healthcare" in a Microsoft function before. From my essay "On Medical Informatics, MIS, and Leadership of Clinical Computing" written in 1998-2000, here is an observation I made in the mid 1990's:

... A letter I had written, " Broken Chord " (third story down) published in the journal Healthcare Informatics , further amplifies the skills and experience issue. The letter addressed issues of skills, insights, and roles of MIS personnel in healthcare settings. I described a Microsoft Healthcare Users Group conference attended predominantly by healthcare MIS staff and vendors, where I observed a panel discussion moderated by the (former) CEO of HBOC and composed of several other industry CEO's. The panel was discussing how they would revolutionize healthcare through their leadership in information technology.

During the Q&A period I asked the audience how many really felt they would revolutionize medicine through their leadership in IT. Several hundred--almost all in the audience--raised their hands. I then asked how many had ever taken care of patients or examined any textbook of medicine, such as Harrison's Textbook of Internal Medicine or the Merck Manual. A minority of hands went up. This suggested, in my view, a striking deficiency of knowledge, experience and insight on the part of the de facto clinical information technology leadership, complicated by cavalier attitudes regarding the essential role of clinical expertise.

The pretension of non-medical computer support personnel in offering profound thoughts on complicated medical matters that they understand, at best, at the level of popularizations, is troublesome. Often, CIO writings in journals of healthcare computing on subjects such as Electronic Medical Records remind me of this. A metaphor to describe the results might be that of a submariner presenting "expert" views on flying a B-52 jet plane. While both are military transporation, in technology specifics do matter.

More from the New York Times story:

The software system Microsoft is buying is called Azyxxi (pronounced ah-zik-see). It is designed to retrieve and quickly display patient information from many sources, including scanned documents, E.K.G.’s, X-rays, M.R.I. scans, angiograms and ultrasound images. It was first used in Washington Hospital Center’s emergency department in 1996, and has since been adopted at six other hospitals, including the Georgetown University Hospital, in the MedStar Health group, a nonprofit network in the Baltimore-Washington region.

The Azyxxi software, Mr. Neupert said, will be “our foundation,” adding, “You’ll find us expanding to a suite of health care solutions.”

This describes a fancy interface engine, a technology used to integrate legacy and disparate information systems that we were using in the late 1990's at Christiana Care, for example, in concert with a commerical Clinical Data Repository (Cerner OCF) to do likewise. I'm not sure what the major innovation here is, considering this system is proprietary to Medstar Health.

Additionally, adopting a proprietary interface engine as "the foundation" of clinical IT offerings iteself is a strategy whose logic escapes me. Generally, an EMR or CPOE is a foundational application in health IT. "Quick and dirty" might better describe this particular strategy outlined in the New York Times.

I'm also uncertain why Microsoft feels their name is going to inspire confidence in clinicians, when those same clinicians have had to deal with MS Windows with all its bugs and faults over the years in the home, and are aware of its serious and constant security issues. I would view the Microsoft imprimatur as a weakness in this industry sector.

More from the article:

The Microsoft plan, analysts say, could be risky. The software Microsoft is purchasing — the price was not disclosed — is a homegrown system that has not been used outside a few hospitals. It has no installed base of customers, and there are already several established suppliers of clinical information technology systems, including Cerner, Epic, G.E., Eclypsis and others.


Most of the big health care software suppliers, analysts point out, are also big customers for Microsoft operating systems, databases and programming tools. “This puts Microsoft in the uncomfortable position of potentially competing against its major customers,” said Dr. Thomas Handler, a health technology analyst at Gartner.

Tom, a former colleague and postdoc in the Yale Center for Medical Informatics, is putting this mildly. I'd say Microsoft is going to really anger some of its major customers, again a puzzling strategy.

At the Washington Hospital Center, the system [interface engine] has done its job. In 1995, before the system was introduced, the emergency ward handled 37,000 patients a year, waits stretched up to nine hours, and there seemed to be an urgent need for more doctors and rooms, Dr. Feied recalled. Today, the emergency department handles nearly 80,000 patients a year and 70 percent of them are diagnosed, treated or admitted in three hours or less. The staff has increased only 5 percent, and few rooms were added.

(As another aside, I do recall the CIO of Medstar calling me on the phone at Christiana Care circa 1997, in a panic, needing to bring his staff and several executives to Christiana Care on an "urgent basis" to review our clinical information systems, especially the clinical data repository. Apparently he had gone on a similar site visit to Texas, but that visit had gone poorly. I rapidly put together a site visit program and gave a good demo to my colleagues from Medstar. As thanks for my efforts that CIO flatly told me "there was not work for me "in his shop several years later I was looking for new opportunities. Ah, gratitude.)

“This is extremely interesting as a signal of Microsoft’s intentions in health care, but we’ll have to see what comes next and how this plays out,” said Dr. Blackford Middleton, an assistant professor at the Harvard Medical School and a health technology expert at Partners Healthcare, a nonprofit medical group that includes Massachusetts General Hospital in Boston.

Blackford, a former senior executive at a company that made an excellent EMR product, Logician, knows well the complexities of this industry. Microsoft, on the other hand, appears to believe that clinical computing and business computing are similar, and that expertise in one makes a company or executive an expert in the other. Bad assumption.

In addition, in the article the Microsoft executive stated his belief that "to really have an impact [in healthcare] you need a footprint like Microsoft's." I disagree. It's not size, it's expertise that counts. A lack of experience and probably even familiarity with social informatics is one major problem here. Sociotechnical issues, not technology, are probably the most important cause of health IT failure such as this recent case " Hospital Vexed by new computer system ", ironically at clinical IT pioneer El Camino hospital. Where, exactly, is Microsoft's expertise in this area (not to mention that these issues often seem ignored by the "experienced' vendors at their peril as the Vexed story illustrates)?

In summary, I think a significant amount of stockholder money and hospital capital, already in short supply, is about to be consumed in this "grand experiment" of leaping from software infrastructure supplier to the curing of all of medicine's ills at the bedside.

Coining a colorful expression for this phenomenon, the Syndrome of Revolutionizing Healthcare Through Ignorance and Hubris™ comes to mind.

Note: also see the posting "Anatomy of Healthcare IT Failure" on an actual, current story of health IT difficulty that occurs even with the involvement of the experienced vendors.

-- SS

Wednesday, July 26, 2006

Won't Get Fooled Again, Again, Again

In mid-July, there were three well-publicized cases in which authors of scholarly articles in prominent medical journals failed to disclose important financial arrangements that may have affected what they wrote. In fact, each case was so well-publicized that I thought it did not need additional comment from Health Care Renewal.

The cases were:
  • An article published in JAMA in February found that withdrawing anti-depressants from pregnant women was associated with relapse of depression [Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499-507.]. A letter published in JAMA in July revealed that "all 9 0f the physician coauthors have been paid by antidepressant manufacturers, while only 2 reported disclosures." (See coverage from the Wall Street Journal, available through the Pittsburgh Post-Gazette here.)
  • An article was published in Neuropyschopharmacology in July about vagus nerve stimulation as a treatment for depression [Nemeroff CB, Mayberg HS, Krahl SE. VNS therapy in treatment-resistant depression: clinical evidence and neurobiological mechanisms. Neuropsychopharmacology 2006; 31, 1345–1355.] The Wall Street Journal discovered that eight of the article's nine authors had financial ties to Cyberonics Inc, the manufacturer of the device. The ninth author is an employee of the company, which was disclosed." (See previous post on Cyberonics here.)
  • An article published in JAMA in July found an association between migraine headaches and the risk of cardiovascular disease and stroke for women [Kurth T, Gaziano JM, Cook NR et al. Migraine and the risk of cardiovascular disease in women. JAMA 2006; 296: 283-291]. The editor of JAMA then discovered that all six authors of the study had financial ties to makers of treatments for migraines or heart-related problems, but did not disclose these relationships, (see the JAMA corrections here, AP here, and PharmaGossip here.)
What has been remarkable is the editorial response to these cases in two of the US most widely-read newspapers.
By Jennifer Washburn in the Los Angeles Times,

Most of us place enormous faith in our universities. We trust that they are autonomous, independent institutions committed to education, scholarship, academic freedom and the production of knowledge free from the influence of special interest groups. Right?

Wrong. In the last 25 years, the United States has given birth to a market-model university, one where professors increasingly work 'for hire.'

Each university is afraid to tighten its rules for fear that this might drive talented faculty (and industry dollars) to other schools with more lax policies. But until the top U.S. research universities collectively adopt one rigorous, uniform policy, their autonomy will continue to erode.
By an anonymous editorial writer in the New York Times, (via the Houston Chronicle),
Leading medical journals seem to be having a difficult time disentangling themselves from the pharmaceutical and medical device industries. If they cannot stop printing articles by scientists with close ties to these businesses, they should at least force the authors to disclose their conflicts of interest publicly so that doctors and patients are forewarned that the interpretations may be biased.
It seems imperative that more muscle be put into forcing disclosure and publication of conflicts of interest. If all leading journals agreed to punish authors who fail to reveal their conflicts by refusing to accept further manuscripts from them, a lot more authors would be inclined to fess up. Better yet, journals should try much harder to find authors free of conflicts. That is the best hope for retaining credibility with doctors and the public.
And by Benedict Carey in the New York Times,
Companies don’t just hire doctors to do research — a practice that in theory ought to help keep businesses scientifically honest — they also trade on the researchers’ names. Like producers shopping a new a movie, they go for star power, an A-list cast with names that themselves sell a product, and pull other doctors along, even when the evidence for a treatment is not strong.

One of the supposed strengths of American science is that it is decentralized and diverse: there are dozens of top researchers who are competitive and critical, enforcing a high standard. But when many or most of the leading figures are playing for the same team — an all-star team — that lineup itself may carry the day, regardless of the science.
With this topic finally getting widespread notice in medical journals and in the main-stream media, I hope it is not hopelessly naive to expect some action. At the very least, we need much more rigorous disclosure requirements for authors of articles in medical journals, and generally for people who bill themselves as academics writing or speaking about medical and health care issues in any venue. In addition, we need broadly based rules about conflict of interest that apply to all people who make decisions in health care.

[For the theme music, go here.]

The Shape of the Financial Arrangements Behind the Publication of the SHAPE Guidelines

The Boston Globe uncovered a new way in which researchers, medical journals, and pharmaceutical firms can get entangled.

The Globe's Stephen Smith discussed the process leading to the publication of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force guideline on screening for coronary artery disease in the American Journal of Cardiology (AJC). (Full citation: Naghavi M, Falk E, Hecht HS et al. From vulnerable plaque to vulnerable patient - part III: executive summary of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force Report. Am J Cardiol 2006; 98[suppl]:2H-15H.)

The SHAPE Task Force is apparently a group of cardiologists who strongly advocate high-technology screening to detect asymptomatic coronary artery disease (CAD). The Task Force wrote a guideline to this effect, even though, per the Globe, "the authors concede [the guideline] is not supported by rock-solid evidence." Unable to get official support from the American Heart Association or the American College of Cardiology, they asked the AJC to publish it in a special supplement. So,
Journal editor Dr. William C. Roberts told the group that, in contrast to how it works in the regular pages of the magazine, if they wanted their recommendations published, they 'would have to have some financial support.'

Dr. Morteza Naghavi, lead author of the guidelines, sent letters soliciting aid to six drug companies. In the letters, which Naghavi supplied to the Globe, he writes that 'the report will be distributed to 100,000 physicians worldwide.'

Naghavi received a favorable response from Pfizer Inc, whose funding of the report is noted in the journal. In an e-mailed answer to an inquiry from The Globe about its contribution, a company spokeswoman wrote that 'Pfizer feels it is important to provide support for efforts that assess novel approaches to reduce the burden of heart disease.'
Once the authors came up with the funding from Pfizer, which summed to $55,800 according to the Globe, the AJC was willing to publish the guideline, which was thereafter "not subject to the standard review process."

According to the Globe, Pfizer's "funding of the report is noted in the journal." Furthermore, "in an appendix to the heart-screening guidelines, several authors acknowledged that they had financial arrangements or affiliations with drug companies or medical device-makers whose products might be influenced by these recommendations."

The guideline is available on the web here, along with an introduction by its authors. As best as I can tell, the versions available on the web do not include any mention of the funding by Pfizer, the financial arrangements of the authors noted above, or any notice that the guidelines were not subject to the standard peer-review process. Several of the guideline authors were listed as Pfizer employees. (ADDENDUM, 24 August, 2006: A comment below suggests that the Pfizer funding is disclosed in the print edition of the journal. I do not have access to the print version, so cannot confirm this, but have no reason to doubt it.)

The guidelines themselves advocated the use of the coronary artery calcification score (CACS) determined by computed tomography (CT) scanning, and the carotid [artery] intima-media thickness (CIMT) determined by ultrasound as screening tests to detect CAD. Although the guidelines were based on extensive citations in the literature, they were not developed using an explicit evidence based medicine process. In particular, the authors did not systematically survey all the relevant literature, and did not critically review the most pertinent articles.

The criteria the guidelines used for recommending screening tests were
(1) the abundance of evidence for the predictive value of the test in the recommended
population over and above that available from standard office-based risk assessment tools (incremental value), (2) availability, (3) reproducibility, (4) complementary
value with respect to the concept of the vulnerable patient, and/or (5) cost-effectiveness relative to the status quo.
These criteria were markedly different from the criteria used by the conservative and evidence-based US Preventive Services Task Force in making screening recommendations. For example, the SHAPE Task Force guidelines seemed to ignore the sensitivity of the tests, whether there was evidence that treating asymptomatic patients whose disease was diagnosed by screening tests would provide better results than waiting to treat patients when they developed symptoms (and particularly whether aggressive treatments of large numbers of asymptomatic patients, particularly with lipid-lowering drugs, might have some adverse effects), and whether the tests, again when employed widely in a screening application, could have adverse effects (especially given the radiation dose from CT scans.)

As former New England Journal of Medicine Editor Dr Jerome Kassirer put it in the Boston Globe,"the whole thing sounds like a conflicted mess, from the recommendations that they're making to the issue of how these journal supplements work." Furthermore, not all the conflicts were disclosed, at least in the web-based version of the guidelines. On the web, the journal failed to disclose that this supplement was published without peer review and was supported by a pharmaceutical company, and that some of the authors had potential conflicts of interest.

Again, this case suggests that physicians and patients need to fully understand the financial (and other) arrangements that could affect opinion and research articles published in medical journals, even when the articles have distinguished authors and are published in reputable journals. We have now seen all manner of such arrangements affecting articles' authors, their institutions, and the journals that publish them. Many of them have gone totally undisclosed, unless discovered by enterprising journalists or academic whistle-blowers. Even those that have been disclosed have not been disclosed in sufficient detail to really evaluate their effects.

Physicians and patients now need to be extremely skeptical about whether such arrangements affect the content or arguments of seemingly scholarly articles published in even the most reputable journals, and may need to be more skeptical about articles which disclose no such arrangements than about those which at least offer some partial disclosure.

Friday, July 21, 2006

$243 Million Gone From UMDNJ

After yet another brief hiatus, UMDNJ is back in the news once again. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See post here, with links to previous posts.)

Per the Newark Star-Ledger, The federal monitor has just released another report, which included an updated estimate of the price-tag of the mismanagement at UMDNJ. The price-tag is staggering. The report said, "At this stage of our review, losses due to 'overbilling,' 'double-billing,' and 'waste' could exceed $243 million," and also, "It must be emphasized that we anticipate that this amount may increase as we continue to do our work."

Among the reports findings were:

- The initial figure of $4.9 million in Medicaid fraud at the university represents 'a mere fraction of the potential fraud, waste and financial abuse that has occurred at UMDNJ.'

- The amount that was double-billed to federal and state Medicare and Medicaid programs by UBHC in the last five years totals more than $35.5 million, and is in excess of $49 million prior to 2001.

- The state's charity care program, which reimburses hospitals for services for the indigent, was double-billed by UBHC for $11.7 million since 2001.

- UMDNJ could face a reimbursement charge of more than $52 million for overpayments from state and federal governments.

- The university's board had virtually no oversight over $104 million awarded in outside contracts in the last five years.

- Between 1999 and 2006, UMDNJ spent $3.9 million on lobbying and government-relations firms, 'all of which was improperly authorized.'

- In the last five years, more than $88 million was paid to outside contractors without the proper paperwork.

- Medicaid was overbilled more than $155,000 for food services to patients at University Hospital in Newark.
One of the most flagrant examples of over-billing for you computer buffs out there was "that $301,660.77 was billed for the simple removal of two malicious software programs -- one so-called 'Trojan horse' and one Spyware protocol -- that were found on just one desktop computer."

Some pithy comments by John Inglesino, counsel to the federal monitor:

There's certainly a fraud component, but there's a tremendous amount of waste. We have found numerous instances where vendors were paid large sums and we found no evidence that any work was ever done. [in the Philadelphia Inquirer]

There’s a culture of entitlement there dating back 20 years. Some of the people there seem to think that the money should go into their pockets or for perks for themselves and their friends. There’s a sense that people don’t have to do their jobs very well in order to remain gainfully employed and they can waste taxpayer dollars and not be held accountable. [in the New York Times]
$243 million - wasted by a single health care university? - And people wonder why health care is so expensive? And academic physicians wonder why there never seems to be sufficient money to pay for teaching and teaching programs (see post here)?

Yet Transparency International's 2006 Global Corruption Report cited corruption as an important, but often ignored drain on health care world-wide.

Will anyone take it seriously now?

By the way, as we mentioned earlier, the debacle at UMDNJ has gone on out of sight of most physicians, and health care and policy researchers, at least those outside of New Jersey. This story has gone unmentioned in any medical or health care journal, as best as I can tell from repeated PubMed searches. The anechoic effect continues. And those who are kept ignorant of history may be doomed to repeat it.

More Stories About the Fall of the FDA

Related, disturbing stories about how far the US Food and Drug Administration (FDA) has fallen have just come out.

Ketek Approval

We previously posted about the ill-fated clinical trial, study 3014, of the antibiotic telithromycin (Ketek) made by Sanofi-Aventis, run by Pharmaceutical Product Development Inc. (PPD). Problems with the trial included fabrication of data at one clinical site, and allegations of manipulation of data at another. The physician in charge of the first site was convicted of mail fraud, and the physician in charge of the second had his license suspended. Although the results of this trial were never published, it still crept into the clinical literature: it was cited in a review article in the New England Journal of Medicine. We also posted about how US Senator Charles Grassley, (Republican - Iowa), chair of the Senate Finance Committee, alleged that the FDA was covering up the process it used to approve Ketek.

Now the New York Times reported that Dr David Graham, now known as an internal FDA whistle-blower, and other FDA scientists challenged the initial approval of Ketek, to no avail. Graham wrote:
It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned.
The Times reported that four other agency officials, including Dr Charles Cooper, Dr David Ross, and Dr Rosemary Johann-Liang, "expressed serious reservations about Ketek."

Senator Grassley commented:

It’s no surprise to learn that the F.D.A. didn’t listen to Dr. Graham on the dangers of Ketek.

The F.D.A. has made it their business to discredit Dr. Graham and others who aren’t willing to cater to the drug companies.
FDA spokesperson Susan Bro countered, "Every issue or question raised during the Ketek review process and subsequently since approval has been rigorously reviewed by the nation’s best physicians, statisticians and epidemiologists both internal and external to the F.D.A."

Vioxx Aftermath

The Associated Press reported (here in USA Today) that Senator Grassley also "asked the inspector general at the Health and Human Services Department to probe whether the Food and Drug Administration and Merck acted in concert to call into question the safety findings made by Dr. David Graham, an FDA drug safety official." The report continued,

In a letter Wednesday, Grassley cited handwritten notes made by the Merck employee documenting an Oct. 13, 2004, conversation with the FDA official that suggests the two collaborated.
The FDA official mentioned an 'opportunity to get (the) message out' on Graham, a longtime employee of the agency, and provide journalists with a company critique of him, according to notes quoted in the letter.

'It is no secret that Dr. Graham was and is a critic of the FDA. However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees,' Grassley said in the letter to Inspector General Daniel Levinson. The FDA, Grassley said, must maintain a 'clear, bright line between the regulated and the regulator.'

This time, FDA spokesperson Bro "had no comment."

Further details provided by AP were:

FDA e-mails seen by The Associated Press indicate that the agency shared in advance with Merck details about a presentation that Graham was to make in France in August 2004 about the dangers of Vioxx. The e-mails suggested that such a practice was commonplace.

Merck then issued a statement saying it stood by the safety of Vioxx. An FDA spokeswoman at the time said removing the drug was 'not on the table.'

The notes excerpted by Grassley indicate the FDA later went even further in helping Merck rebut Graham's work.

The FDA's Dr. Brian Harvey suggested to Merck's Dr. Ned Braunstein 'an official rebuttal on Graham,' according to the notes, which were admitted as evidence in a federal Vioxx trial.

Graham said he was 'quite shocked' to learn about Braunstein's notes.
FDA Employee Survey

The Baltimore Sun reported on a survey by the Union of Concerned Scientists of FDA scientists. The survey was sent to 5918 people, of whom 997 responded. The Sun reported that key findings were:
  • "Fifteen percent of the 997 FDA scientists who answered the questionnaire said they were asked to keep information out of agency documents or alter their conclusions for nonscientific reasons."
  • "Nearly one in three said the FDA doesn't routinely provide complete and accurate information to the public."
  • "37 percent said the agency's leadership wasn't as committed to product safety as to approving products for sale."
  • "Fifty-two percent said their job satisfaction had fallen the last few years, and 70 percent said the agency lacked the resources to carry out its mission."
  • "two out of five scientists saying superiors didn't consistently stand behind staff whose "scientifically defensible positions" might have been politically controversial."
  • "Eighty-one percent of respondents said the agency needed to strengthen its oversight of drugs after they go on sale."
Responses were bi-partisan. Senator Barbara A Mikulsi (Democrat - Maryland) responded, "This agency has been politicized and degraded. Many FDA employees don't feel the FDA is doing enough to protect the public's health and are afraid to speak candidly about it." Senator Grassley responded that the FDA needs "major overhaul and a culture change at the highest levels." He also said it "needs to re-establish its relationship with its own scientists and distance itself from the drug industry. The FDA needs to get rid of its mindset that it's a facilitator for the drug industry and become regulator once again. The FDA's focus should be only on science and the public good."

Spokesperson Bro responded by criticizing the "scientific rigor" of the survey, and charging "This is a counterproductive exercise based on leading questions and innuendo. For centuries, science has depended on rigorous and disciplined processes to distill truth from exploration and debate -these principles above all others guide our daily work at the FDA on behalf of the American public health."

By the way, regarding technical issues about the survey: I agree that a response rate of less than 20% does raise concern about the generalizability of the results of the survey. However, given the content of the responses (and given the content of some written comments made on the sruvey), these results are still very disturbing. And I'm not sure on what Ms Bro's charge that the survey questions were "leading" was based.
Unfortunately, these stories make it even more imperative for doctors and patients to be extremely skeptical about what they are being told about pharmaceutical products, even by the formerly respected FDA.
These stories added together suggests that Senator Grassley's call for a complete overhaul of the FDA is on target. Unfortunately, the FDA, once regarded as a paragon of integrity (albeit one that may have been ponderous, bureaucratic, and sometimes inefficient), seems to have fallen into the same muck that too many other health care organizations, from hospitals to to managed care organizations to pharma and device manufacturers now occupy. Thus now doctors and patients must be extremely skeptical about nearly anything they hear about health care when it is said by someone who could possibly have vested interests other than improving patient care or the integrity of science.

We have a lot of overhauling and much-raking to do. Meanwhile, we have to work in a health care system in which doubt, ambiguity, and skepticism rule.

NOTE: See the takes on this by Pharma Gossip here, here, and here. See a related story by Dr Aubrey Blumsohn on the Scientific Misconduct blog here.

Monday, July 17, 2006

How Hospital CEOs Get Paid Tens of Thousands to Advise Hospital Suppliers

The New York Times just reported on the activities of an organization called the Healthcare Research and Development Institute (HRDI).

Despite its name, HRDI is a "for-profit company owned by about three dozen hospital executives, but underwritten by 40 or so of its handpicked corporate members, all suppliers to hospitals." These "executives benefit from payments made by companies their hospitals do business with." HRDI industry members are limited to "only two competing companies in any specific field."

The purpose of the organization is apparently to give hospital suppliers access to the CEOs of large not-for-profit hospitals. "Last May, more than 130 representatives from 40 health care companies were scheduled to attend confidential consulting sessions at the Broadmoor, a Colorado Springs hotel. When not attending the sessions, hospital chief executives and suppliers mingled at company-sponsored tennis, golf and social events. Each year, H.R.D.I. holds two gatherings like the one in Colorado, where each corporate member gets a meeting of up to three hours with five or six chief executives, according to [HRDI CEO]Mr. Mecklenburg." "'The typical organization is paying $40,000,' Mr. Mecklenberg said. 'It can be more, but that would not be typical.' Additional access to hospital executives and their institutions can cost companies $55,000 a year or even more. For example, a special two- to three-day visit to a specific hospital costs $2,000 a person, according to H.R.D.I., which says most of that money is eventually passed on to the hospital."

"It is unclear exactly how much hospital executives, who are the shareholders of the healthcare institute, earn annually for consulting at the two conferences. Asked to verify a report that some members earned as much as $50,000, Mr. Mecklenberg initially denied it. 'Our observation and recollection is $20,000 to $30,000 a year,' he said. 'It may be more than that but we don’t have data in front of us, but it’s certainly not $50,000.'

Mr Mecklenberg himself has an interesting history. He is "a former chairman of the American Hospital Association, the industry’s largest trade group." Furthermore, now he "not only runs a large nonprofit hospital, Northwestern Memorial in Chicago, but he also serves on the board of Becton, Dickinson and Company, a major supplier of medical devices to hospitals around the world, including his own. Becton, Dickinson pays the institute for marketing advice, and the institute pays Mr. Mecklenburg $50,000 a year, mostly for participating in two national conferences, according to the group."

HRDI is now under the scrutiny of Connecticut Attorney General Richard Blumenthal, who "is investigating whether the organization allows certain vendors to buy access to hospital leaders who are in a position to influence what supplies or services their institutions purchase. As a result, Mr. Blumenthal said, hospitals may not be getting the best deals, either in terms of cost or quality. 'At the very least it suggests insider dealings — an insidious, incestuous, insider system,' said Mr. Blumenthal...." He is also investigating whether the limitation on HRDI membership to only two companies from each sector violates anti-trust regulations. Mr Blumenthal recently testified that HRDI is a "secretive" network of "ethically questionable business arrangements." Note that until recently, the organization did not allow public access to its web-site, and did not list its members, although its current membership list and list of corporate sponsors are currently on the web.

The Times' investigative reporting has opened yet another window on the pervasive web of conflicts of interest that entangles health care. The report reveals problems at multiple levels:
  • Hired leadership of not-for-profit hospitals seem to be personally profiting from their positions of trust
  • Hospital leaders not only have cozy relationships with at least some suppliers, but are paid handsomely by these same suppliers for their supposed market advice, raising questions about how effectively their hospitals will negotiate with these suppliers
  • The leader of the organization that makes these cozy relationships possible is simultaneously a not-for-profit hospital CEO and a member of the board of directors to a major hospital supplier, and hence has a fiduciary duty to that organization that seemingly clashes with his duty to his main employer
You just can't make this stuff up.
And people wonder why health care is so expensive? And think that the only solution to the rising cost of health care is to keep cutting physicians' fees for "cognitive services?" (See post here.)
Note that the well-publicized article by Brennan et al that castigated physicians for accepting so much as a coffee mug with a company logo from a drug or device company would have put academic medical center administrators in charge of enforcement of this stringent policy, the same administrators who may personally get paid tens of thousands of dollars to sit give market advice to the companies whose logos are on the coffee mugs. LOL. (See post here.)
Instead, as we have said before, there needs to be a broad, impartially enforced policy that bans major conflicts of interest affecting all decision makers in health care.
And we need some of leaders of large health care organizations, not just pharma and device companies, but also managed care organizations and insurance companies, hospitals, academic medical centers and health care systems, and medical schools and universities, to to look in the mirror to see who has been dodging responsibility for rising costs, declining access, stagnant quality, and demoralized providers.

MedPundit is Back Too

And now MedPundit is back too. Every day things get better and better in every possible way. Could Healthy Policy be next?

More Ambiguous Financial Arrangements at the NIH

We have posted frequently, most recently here and here, about conflicts of interest affecting top US National Institutes of Health (NIH) scientists and leaders.

The Los Angeles Times again has published another investigative report (in two articles, here and here) on relationships between officials at the NIH and pharmaceutical and bio-technology companies. The articles focused on Dr Thomas J Walsh, Head, Immunocompromised Host Section, Pediatric Oncology Branch, Center for Cancer Research and the National Cancer Institute (NCI).

The articles raise two questions:

  • Were Walsh's spoken or written comments about anti-fungal drugs influenced by his relationships with several pharmaceutical companies, particularly when Walsh was speaking to US Food and Drug Agency (FDA) advisory panels as an NIH scientist?
  • Were clinical studies of these drugs, with which Walsh was involved in a variety of ways, designed so that they were likely to favor particular drugs?
Since the issues raised by the second question are very complex, I can't hope to try to answer it without spending a lot of time reading reports of all the trials, and relevant background information. So I will set it aside for now.

The issues raised by the first question are perhaps clearer. I will summarize what the articles said about Dr Walsh's relationships with several companies.

Merck & Co
By 1999, Walsh was collaborating with Merck & Co., on its new antifungal drug, Cancidas.

Merck persuaded the FDA to conduct a fast-track review of Cancidas for a more narrow use: treating aspergillus in patients who had either not tolerated or failed to improve while taking another antifungal drug.

On Jan. 10, 2001, representatives of Merck — assisted by Walsh — presented the company's case for approval of the drug to the FDA advisory committee in Bethesda.

Walsh, in his statement to The Times, said: 'I did not appear as a consultant to Merck.'

But that is how Merck identified him to the FDA committee, both orally and in a slide.

Tamara Goodrow, a Merck regulatory affairs official, said: 'Merck has brought several consultants to the meeting today so that they are available to facilitate the advisory committee's discussion and deliberations.' Goodrow then named the consultants, including 'Dr. Thomas Walsh.'
Another Merck official said Walsh served as the head of a company committee of three researchers who assessed how patients with aspergillus infections had responded to treatment with Cancidas in the smaller company study.

A videotape of the meeting shows, Merck's senior director of clinical research, Dr. Carole A. Sable, gestured to the audience and said: 'Perhaps Dr. Walsh, who is actually the head of our expert panel, would like to make a comment.'

Walsh strode to the podium, took the microphone and assured the FDA committee that Merck's case-by-case information for the 69 patients was reliable.

An editorial by Walsh, published in December 2002 by the New England Journal of Medicine, referred to an antifungal drug made by Merck & Co. — but did not mention his receipt of fee income from the company. The journal's conflict-of-interest policy requires authors to acknowledge such income.

After inquiries from The Times, the journal asked Walsh to submit a revised disclosure statement. A spokeswoman for the journal, Karen Pedersen, said Walsh had 'failed to disclose' the income from Merck when he submitted the editorial. On March 16, the journal published a correction, saying the editorial 'should have included the fact that Dr. Walsh received an honorarium from Merck.'

Walsh told The Times that his lack of disclosure was inadvertent.

A Merck spokesman said recently that Walsh was paid a total of $3,000 in fees, in 1999 and 2001, not related to his involvement with the company's drug. Walsh said in his statement to The Times that Merck had not paid him for any appearance before the FDA.

U.S. conflict of interest law generally prohibits a federal employee from representing anyone before a government agency, regardless of whether outside compensation is paid.
Fujisawa USA Inc
The first major study that Walsh helped lead compared one of the new, modified drugs, AmBisome, with conventional amphotericin.

The study was paid for by the developer of the new drug, Fujisawa USA Inc., and by a grant from the NIH. Walsh had conferred about the study design with Fujisawa and with a national network of other physicians who would carry out the project.

On July 16, 1997, Walsh anchored Fujisawa's presentation of AmBisome to the FDA advisory committee, which met in Silver Spring, Md. The FDA's agenda listed Walsh as part of the 'Fujisawa USA Presentation.'
Fujisawa's vice president for regulatory affairs, Jerry Johnson, told the FDA committee: 'Our presentation will conclude with Dr. Walsh presenting the key results from the U.S. study.'

Walsh narrated a series of slides and told the committee that AmBisome 'was more effective in preventing proven invasive fungal infections and fungal-infection-related deaths' than conventional amphotericin.

In his recent statement to The Times, Walsh said: 'I have never appeared at any FDA meeting as a consultant to Fujisawa.' Referring broadly to industry, Walsh also said: 'While a company might consult with me, i.e., in the generic sense of seeking my insights or knowledge, these are not consultancies in the official, governmental sense, but rather collaborations.'

A spokeswoman for Fujisawa, which now operates as Astellas Pharma US Inc., said the company had paid the NIH for Walsh's efforts dating to the 1990s and the development of its first antifungal drug, AmBisome.

'He's been a consultant of ours since the early days, since the preapproval of AmBisome, through currently,' said the spokeswoman, Maribeth Landwehr, adding that the company had paid for Walsh's 'general consulting' by writing checks to the NIH, not to him. Fujisawa, she said, paid 'at a rate which we believe to be acceptable.'

Vestar Inc., a San Dimas company that developed AmBisome originally and later in partnership with Fujisawa, also worked closely with Walsh. Richard T. Proffitt, a co-inventor of AmBisome who headed research for Vestar, said the company collaborated with Walsh on testing the drug in animals.

Proffitt said Walsh suggested that Vestar could make contributions to a foundation that would make funds available for Walsh's research. Proffitt said that from about 1990 to 1993, Vestar wrote checks, totaling approximately $60,000, to the foundation. Proffitt said he did not recall its name. 'It wasn't like he implied that we had to give money to the foundation,' said Proffitt. 'But he certainly gave me the foundation name.'

Records obtained under the Freedom of Information Act show that some companies supported Walsh's government research by making donations to the Gift Fund of the National Cancer Institute.

For instance, in March 1998, Fujisawa sent Walsh a $40,000 check to the fund along with a letter of explanation, saying the money was intended for his government laboratory and '"clinical research program.' Fujisawa also told Walsh that the money could be used for 'personnel, support services and travel,' plus equipment and supplies.

After reviewing the NIH's overall policy for accepting gifts, the Government Accountability Office last year raised concern. The federal auditors said the NIH's policy 'does not provide sufficient assurance that potential conflicts of interest between NIH and donor organizations will be appropriately considered.'
Pfizer Inc.
Walsh also has consulted with Pfizer, said Mariann Caprino, a spokeswoman for the company. She said Walsh was paid from 2001 to 2005 for participating in private meetings at Pfizer 'to discuss clinical trial designs.'

'We did compensate him for his time,' Caprino said in an interview.

When Pfizer brought its antifungal drug before an FDA advisory committee in October 2001, a company executive identified Walsh as part of its 'sponsor section.' The FDA approved the drug, Vfend, about seven months after the advisory committee meeting.

'He attended the advisory committee in the capacity of an expert in this area,' Caprino said, adding: 'His relationship was fully disclosed by us at that meeting.'

Walsh said that he was not paid by Pfizer to attend the meeting. He did not respond to questions seeking details about his compensation from Pfizer.

Caprino declined to state how much Pfizer had paid Walsh over the years, but said: 'He received a standard per-diem rate. Basically, that compensates him for time out of the office.'
In response to questions from the LA Times,
In written comments for this article, Walsh said his advice to industry did not conflict with his position at the NIH's National Cancer Institute, or affect his scientific judgment.

'I am not and have never been a representative of, or advocate for, any pharmaceutical company,' Walsh said.

Walsh, 54, heads a medical research and treatment unit within the pediatric branch of the National Cancer Institute, where he arrived in 1986. He said that collaborating with companies has been fundamental to his government work.

'My efforts are in service of the public interest in sound, reliable science concerning potentially effective agents for the treatment of life-threatening infections in children and adults with cancer,' Walsh said in a statement to The Times. 'This mission frequently includes collaboration with companies that research and develop new compounds in this area — for example, utilizing my [staff's] expertise to ensure that clinical trials relating to these compounds are designed and implemented in a manner that elicits reliable and useful results.'

He said he has appeared before the FDA only 'as a government scientist providing information and/or evaluation' regarding clinical trials. Referring to studies he helped lead, Walsh said, 'There is no conflict of interest, and the trials were well and appropriately designed.'
This tangled story reminds us of several points.

When people have financial relationships with multiple organizations with differing agendas, it is hard to tell who they are representing at any given time.

People who have such financial relationships often seem honestly unaware of how others may perceive the relationships, and seem to ignore the influence of particular relationships, while acknowledging the influence of others.

My conclusions are:
  • There is nothing wrong with government-industry, or academia-industry collaborations.
  • However, those physicians, researchers, faculty, and administrators involved in such collaborations should not try to work for two or more parties whose interests are not necessarily the same.
  • If the actors in a particular collaboration do have conflicts of interest, the rest of us must be very skeptical about interpreting what they say and understanding what they do
With any luck, since the NIH has restored the rigor of its policies about conflicts of interest, its collaborations with industry should produce less ambiguous results.

It would be nice if other government agencies, and also academic medical institutions, would also develop much more rigorous policies about conflicts of interest. Meanwhile, we need to be very skeptical about assessing their work.

Sunday, July 16, 2006

More Lucrative Stock Options for Top Health Care Company Executives

The Wall Street Journal has reported yet another way companies have developed to make stock options more lucrative for their top executives. Two examples cited involved well-known health care companies. (Since the article is not available without a subscription, I will quote extensively.)

On Sept. 21, 2001, rescuers dug through the smoldering remains of the World Trade Center. Across town, families buried two firefighters found a week earlier. At Fort Drum, on the edge of New York's Adirondacks, soldiers readied for deployment halfway across the world.

Boards of directors of scores of American companies were also busy that day. They handed out millions of bargain-priced stock options to their top executives.

The terrorist attack shut the U.S. stock market for days. When it reopened Sept. 17, stocks skidded more than 14% over five days, in the worst full week for the Dow Jones Industrial Average since Germany invaded France in May 1940. But for recipients of options, the lower their company's stock price when options are awarded the better, since the options grant a right to buy shares at that price for years to come. The grants set recipients up for millions of dollars in profit if the shares recovered.

Ninety-one companies that didn't regularly grant stock options in September did so in the first two weeks of trading after the terror attack. Their grants were concentrated around Sept. 21, when the market reached its post-attack low.

Stock options were originally designed to align executives' incentives with the goals of shareholders, encouraging recipients to work hard to improve their companies' stock price. When those options are granted at favorable prices, executives get some of their gain free -- that is, they get a chance to buy in an unusual dip below the price many investors have paid.
There's nothing illegal about granting options after the market plunges. But acting so quickly after a national tragedy drove down stocks shows the eagerness of some companies to increase their executives' potential wealth. These grants also offer important new fodder for an already fractious debate over what constitutes the proper use of options in executive compensation.

UnitedHealth Group

Some of the post-9/11 grants were extraordinarily well-timed, hitting the exact low for the period. At least six of the companies that granted options dated after the attack are under investigation in the wider options-timing probe. That raises the question of whether some grants that appear to have been granted in the post-attack period were actually made later, then backdated.

UnitedHealth, which granted stock options dated shortly after the terror attack, also faces investigations of its other options practices by the Securities and Exchange Commission and federal prosecutors. The former CEO of one UnitedHealth unit, R. Channing Wheeler, received option grants dated on quarterly lows for four straight years, 1999 through 2002. In September 2001, UnitedHealth gave Mr. Wheeler 96,000 options, adjusted for later stock splits, priced at the managed-care company's post-9/11 quarterly low. UnitedHealth declined to comment and Mr. Wheeler didn't return calls.

On UnitedHealth's compensation committee in September 2001 were New York investor William Spears, Columbia University nursing dean Mary Mundinger and former New Jersey Gov. Thomas Kean -- later head of the federal commission that investigated Sept. 11 intelligence failures. Mr. Kean and Ms. Mundinger didn't return calls, while Mr. Spears declined to comment.

Stryker Corp

At Stryker Corp., a Michigan maker of orthopedic products, onetime stock-option-committee member John Lillard said he didn't regret the decision to award options nine days after the attack. 'If you believe the company is going to do well, and here is an external event that is affecting the market and you've made a decision to reward executives, you go ahead with it,' Mr. Lillard said. 'Life goes on.'

At Stryker, in Kalamazoo, Mich., post-9/11 stock-option grants to several executives appear to have been initiated by the chairman and CEO at the time, John W. Brown. They were dated Sept. 20, 2001, at the bottom of a sharp 'V' pattern in the share price.

Mr. Brown would 'periodically tell us if he thought the stock was attractive,' and then the board would decide whether to award options, said Mr. Lillard, the former member of Stryker's stock-option committee. 'We didn't just sit down after Sept. 11th and say, 'Gee, how can we take advantage of this?' ' Mr. Lillard said. Besides, he added, no one could have known whether the stock would rebound immediately or continue to slide.

Mr. Brown said that for the past 10 to 12 years, the company, to compensate for a relatively small number of options given to executives, has tried to 'pick what we think would be the low point of the year. That's what we're gunning for.'

Stryker's option grant came on the lowest closing stock price for the second half of the calendar year. Mr. Brown said he believes that he called both members of the stock-option committee on Sept. 20 to recommend they choose that day to grant options. He added that he couldn't remember a time when the board didn't follow his advice.

Mr. Brown said that while he didn't remember the details of the 2001 grant, 'that was the year of 9/11. I'm sure that the market hammered us and that was the reason I was doing it at that time.'

Mr. Brown, still chairman but no longer CEO, said he could understand how it might strike some as unseemly to give executives stock options so soon after a catastrophe. 'That would be a legitimate point, I suppose,' he said.

He added that in retrospect, he probably wouldn't have advised that the grant be given. Today, Mr. Brown said, Stryker gives its grants during a relatively narrow period in the spring.

This seems yet another illustration about how focused the top leadership of large health care corporations are on the compensation they receive.

Furthermore, as we have commented before (here and here, and see links to earlier posts), there has been a marked contrast between the compensation received by UnitedHealth Group top executives, especially CEO Dr William McGuire, and the company's mission "to make health care more affordable."

And we wonder why health care is so expensive, and why health care costs rise faster than inflation?

Friday, July 14, 2006

Widespread Conflicts of Interest at Stanford: the Dean Responds

In an a commentary fo the San Jose Mercury News, Dr Philip A Pizzo, the Dean of the Stanford University School of Medicine responded to the series of articles in that newspaper documenting widespread conflicts of interest at the Medical School, which we posted about here and here. Some key quotes:

What would be the cost to the health of the American public if such ties between academia and industry were severed?

It should be noted that the federal government has explicitly promoted these ties since 1980, when Congress enacted the Bayh-Dole act, which authorized and encouraged universities to hold ownership of inventions made under federal funding. In fact this law mandates universities and private industry to work together to bring the fruits of university research to the public. This process has resulted in many medical innovations and advances that have improved the lives of millions of Americans.

There are now some 1,000 therapies and technologies that are based on university-licensed discoveries.

Of course, collaboration between university researchers and private companies carries with it the potential for conflicts of interest. The July 9 article describes one way Stanford addresses this: by requiring faculty members to disclose potential conflicts, regardless of the dollar amount of the financial interest.

But disclosure is far from the only strategy that the Stanford School of Medicine uses to protect the public's interest. When we identify a significant conflict, we take steps to eliminate, mitigate or manage it. These steps include modifying the research plan, disclosing the conflict to the public, disqualifying a faculty member from participating in all or a portion of a research project and in some cases requiring the faculty member to sever a relationship with industry.

As for the July 10 article, it is important to point out that Dr. Alan F. Schatzberg's research over the past 25 years has been consistently subject to rigorous peer review by scientific leaders at the National Institutes of Health and throughout the nation. His research findings have been published in highly respected peer-reviewed medical and scientific journals.

It is misleading to air criticism of his pilot studies for lack of statistical significance when, in fact, the studies were exploratory and not designed to show statistical significance in the first place. More important, and above all, through his research and care of patients, Dr. Schatzberg is a man devoted to alleviating the pain and suffering of those who face the challenge of the most severe and chronic forms of depression.

Dr Pizzo's response did not seem to address the points made in our previous posts about the conflicts at Stanford. (Of course, he probably has not read our posts.)

It also seems important to note that criticizing conflicts of interests does not mean criticizing the general concept of industry-academic collaboration. However, there are many ways in which universities and corporations can interact that minimize such conflicts. For example, for-profits can sponsor research at universities, but need not control the design and implementation of studies, and the analysis and dissemination of their results.

However, the examples described in the San Jose Mercury News were not simply of academic researchers collaborating with industry. They included researchers and academic leaders who owned substantial numbers of company stock options, who had corporate administrative titles, or who sat on corporate boards while doing research on the companies' products, or as full-time academics expressing opinions on topics relevant to the companies' products. It is not clear why university researchers need to get stock options, administrative positions, or board memberships from corporations in order to work collaboratively with them.

Furthermore, how can an academic be "full-time" while working for industry in an administrative position, or getting the sort of incentives that corporations usually only give to top management and key employees? At a minimum, a person in such a situation should acknowledge being only a part-time academic.

Finally, an academic who also works for industry ought to make completely transparent what masters he or she serves when expressing opinions about topics relevant to the company's product or service. Such opinions may be regarded differently than those from true full-time academics. But that's life.

However, what sort of trust is inspired when an author of scientific articles about a drug turns out to be not just a full-time university professor with some "financial interest" in the company that makes the drug, but the Chairman of the Board of the company?