More Wooden-Headed Reimbursements and Perverse Incentives: Medicare Proposes Penalty for Supposed "Never Events"

The Associated Press just reported that the US Center for Medicare and Medicaid Services (CMS), which administers the Medicare single-payer insurance system for elderly and disabled Americans, just proposed a new policy for paying hospitals:

Federal health officials on Monday proposed adding dangerous blood clots in the leg and eight other conditions to the list of complications that Medicare won't pay to treat if they were acquired at the hospital.

Medicare set a new precedent last year by saying it would no longer pay hospitals for treating certain "never events" — conditions that occur as a result of hospital error. For example, if a patient were given the wrong blood type, Medicare would not pay the hospital more for the subsequent care a patient required. Originally, eight conditions were covered under the new rules, which take effect Oct. 1.

The rules proposed Monday add nine conditions....

The full list of conditions was not in the article, but can be found in a CMS press release:

* Surgical site infections following certain elective procedures
* Legionnaires’ disease (a type of pneumonia caused by a specific bacterium)
* Extreme blood sugar derangement
* Iatrogenic pneumothorax (collapse of the lung)
* Delirium
* Ventilator-associated pneumonia
* Deep vein thrombosis/Pulmonary Embolism (formation/movement of a blood clot)
* Staphylococcus aureus septicemia (bloodstream infection)
* Clostridium difficile associated disease (a bacterium that causes severe diarrhea and more serious intestinal conditions such as colitis)

That press release further asserted,

The Centers for Medicare & Medicaid Services (CMS) today proposed additional steps to strengthen the tie between the quality of care provided to Medicare beneficiaries and payment for the services provided when they are in the hospital.

CMS is proposing to expand the list of conditions which are reasonably preventable through proper care and for which Medicare will no longer pay at a higher rate if the patient acquires them during a hospital stay.

Thus, this proposal would be a form of a pay-for-performance (P4P) system, and one based on outcomes. That is, if the patient develops one of the conditions above while in the hospital (the outcomes), the hospital's performance is deemed inadequate, and the hospital is paid less.

This, in my humble opinion, seems a remarkably wooden-headed way to implement P4P for hospitals. The problems here are:

• The outcomes are at best only partially preventable. There are no clear way to completely, or even nearly completely prevent most of these outcomes
• The outcomes more commonly afflict sicker and more complex patients.

Let us examine, for example, one outcome about which I know something more than the others, delirium occurring in the hospital.

A Cochrane review of "interventions for preventing delirium in hospitalised patients," published in 2007, included only six studies, all in surgical settings [Siddiqi N, Stockdale R, Holmes J. Internventions for preventing delirium in hospitalised patients. Cochrane Database of Systematic Reviews 2008. Link here. ]. The review found only one study that appeared to be adequately powered. The review's abstract described that study thus,

Only one study of 126 hip fracture patients comparing proactive geriatric consultation with usual care was sufficiently powered to detect a difference in the primary outcome, incident delirium. Total cumulative delirium incidence during admission was reduced in the intervention group (OR 0.48 [95% CI 0.23, 0.98]; RR 0.64 [95% CI 0.37, 0.98]), suggesting a 'number needed to treat' of 5.6 patients to prevent one case.

It is obvious that although this intervention reduced the incidence of delirium, it hardly totally prevented it.

The review concluded,

Research evidence on effectiveness of interventions to prevent delirium is sparse. Based on a single study, a programme of proactive geriatric consultation may reduce delirium incidence and severity in patients undergoing surgery for hip fracture. Prophylactic low dose haloperidol may reduce severity and duration of delirium episodes and shorten length of hospital admission in hip surgery. Further studies of delirium prevention are needed.

Furthermore, a well-known predictive model for in-hospital delirium [Inouye SK, Viscoli CM, Horwitz RI et al. A predictive model for delirium in hospitalized elderly medical patients based on admission characteristics. Ann Intern Med 1993; 119: 474-481. Link here. ] suggested that sicker patients (that is, those with "severe illness," pre-existing cognitive impairment, and a high BUN/Creatinine ratio) are more likely to get delirium.

Is delirium a "never event?" Well, hardly ever...

Thus, it appears that the surest way to avoid incurring CMS' proposed financial penalty for delirium occurring in the hospital would be to avoid admitting sicker patients who are most likely to become delirious. This, of course, is a perverse incentive that could make care less accessible for those who need it the most, and would violate hospitals' fundamental mission to care for the sick.

Similarly, I would challenge the brainiacs who came up with this proposed rule to show how any of the supposed "never events" could be reliably prevented, short of turning away the sicker patients who are likely to suffer these events.

This is an example of wooden-headed and perverse incentives at their worst, perpetrated by government bureaucrats who apparently have no understanding of the practice of medicine in the hospital.

This comes from the same folks who rely on the secretive RBRVS Update Committee (RUC) to come up with a reimbursement scheme that does not allow physicians enough time to interact with, get information and actually think about their patients. (See post here.)

Paying physicians for the time it takes to gather information, think about it, and thoughtfully come up with the best possible plan for each individual patient would do a whole lot more to improve quality and patients' outcomes than penalizing hospitals (and physicians indirectly) for events that they could not have prevented.

Woe unto us for turning control of health care's largest and most powerful organizations over to wooden-headed bureaucrats and ill-informed, self-interested, and sometimes corrupt executives!

ADDENDUM (18 April, 2008) - See comments by DrRich on the Covert Rationing blog.

ADDENDUM (22 April, 2008) - See also comments on Retired Doc's Thoughts blog.

Organizational Learning Disability? Miami Beach Hospital gets an "F" on Informatics

I've commented at "External oversight needed for hospital EMR implementation" and "Yet another clinical IT controversy: UC Davis" on the enormous amounts of money for EMR's being spent by HC organizations.

Tens or hundreds of millions of dollars -- costs equal to the cost of entire new hospitals, and approaching the budgets of major multinational pharmaceutical companies on research IT -- are being spent by individual healthcare organizations on clinical IT.

I consider such costs unreasonable, and feel they are in significant part due to suboptimal management and/or mismanagement of these initiatives. I've personally observed how lack of informatics expertise, false assumptions, underestimations of difficulty, conflicts of interest, "padding", and other forms of mismanagement drive up IT costs in hospitals.

I cannot fail to be stunned when I observe a serious "learning disability" (to be polite about it) in a major HC organization I interacted with and actually tried to teach, using materials that my graduate students find valuable and informative as they pursue a Certificate in Healthcare Informatics while working in HIT. It's a sad but fascinating phenomenon to watch.

In August 2007 I was contacted about a position as "Director of Medical Informatics" at Mount Sinai Medical Center in Miami Beach, a 700+ bed medical center preparing to implement EMR's and other clinical IT. They'd found my CV online and contacted me for an interview.

I considered the location excellent since I have relatives who've moved down that way, and the fit excellent as I'd successfully held the same role at a 1000+ bed regional medical center in Delaware, in addition to having many new insights since then from developing a Graduate Certificate Program and teaching healthcare informatics to graduate students in IT, healthcare and library sciences at a major university.

I traveled to the organization for interviews in Sept. 2007. I found the executives and medical leaders polite but very inexperienced with regard to clinical IT.

I made the case that since medical center health IT problems and failures were common, the highest levels of expertise were essential to project cost efficiency and success.

I called their attention to the NIH training programs in Medical Informatics. I cited national informatics expert Dr. William Hersh on his statement that "it is unwise spending millions on Electronic Medical Records without investing thousands in Medical Informatics expertise." I directed the executives and medical leaders I spoke with to my web site on health IT difficulties and to my Drexel course syllabus, extensive sociotechnical article collection and other literature posted on these issues in the "other resources" tab. Gratis.

Unfortunately, the medical center failed to get back to me about the outcome of the interviews despite several inquiries. This itself was rather impolite, but it happens.

In March 2008 I inquired again (partly as they still owed me travel expenses, although that was my fault as I became distracted by other matters and did not send the receipts). I received this cryptic message from HR:

We did not mean to just forget about you. We decided to move forward with other applicants for a variety of reasons ... For whatever reason, it did not feel like the “right fit”.

Now, any organization is entitled to "feel" a candidate is "not the right fit." It's their organization. I construed this as akin to, say, a real estate company telling Donald Trump that there was not "the right fit", but again, it is their organization.

However, when an organization has a history that includes the following issues, perhaps their "feelings" represent dysfunction rather than state-of-the-art thinking about healthcare and healthcare IT.

A new job ad that just appeared that I reproduce below confirmed this.

Read on:

This medical center has had some major if not "extinction-level event" computing and executive competency and integrity problems before, presumably related:

Before the SECURITIES AND EXCHANGE COMMISSION

In the Matter of Mount Sinai Medical Center, M. Brooks Turkel and Harvey V. Smith (pdf):

I. The Securities and Exchange Commission (“Commission”) deems it appropriate that cease-and-desist proceedings be, and hereby are, instituted ... against Mount Sinai Medical Center of Florida, Inc. (“Mount Sinai”), M.Brooks Turkel (“Turkel”) and Harvey W. Smith (“Smith”) (collectively, “Respondents”).

2. Respondent Turkel, age 40, was Chief Financial Officer (“CFO”) of MountSinai from January 1999 through mid-July 2001, and served as Mount Sinai’s chief planning officer from mid-July 2001 until he was terminated in October 2001.3. Respondent Smith, age 58, served as chief operating officer (“COO”) ofMount Sinai from May 2000 until he was administratively suspended in December 2001 by MountSinai and officially terminated in January 2002.

... 5. The Official Statements to the bond offerings contained Mount Sinai’s audited financial statements for the years 1999 and 2000 ... The Official Statements contained an anti-fraud certificate, signed by Mount Sinai’s former Chief Executive Officer (“CEO”), wherein the CEO certified on behalf of Mount Sinai that: (i) the statements and information contained in the Official Statement were true, correct and complete in all material respects; (ii) the Official Statement did not contain any untrue or incorrect statements or omissions of material fact; and (iii) Mount Sinai’s financial condition had not materially or adversely changed since December 31, 2000.

... 9. Mount Sinai, through Turkel, Smith and other former senior management, failed to disclose the hospital’s deteriorating financial condition at the time of the offering. Specifically, Mount Sinai failed to disclose in the Official Statements that the hospital was experiencing a significant deterioration in its cash position and was in the midst of a severe liquidity problem. Indeed, Mount Sinai’s financial condition began to materially decline after it underwent a computer conversion in December 2000 to update its patient accounting system within its business office. The computer conversion gave rise to major problems that substantially impacted Mount Sinai’s billing and collection process.

For example, Mount Sinai experienced substantial delays inbillings and a significantrise in failed billings to third party payors. In addition, the hospital’spatient accounts receivable grew substantially -- increasing from approximately $70 million at the end of December 2000 to over $90 million by June 30, 2001. As a direct result of its billing and collections problems, Mount Sinai’s cash position began to materially worsen after December 2000 and continued to worsen through at least the time of the issuance of the 2001 bonds in May.

They've also had serious leadership problems with competence and talent:

Executive Recruiter Sued by Mount Sinai in FL

... one of the [The National Center for Healthcare Leadership']s architects--Heidrick & Struggles, the nation's biggest executive recruiting firm and a longtime NCHL champion--is embroiled in a lawsuit that may test the validity of the premise that healthcare is woefully bereft of future leaders.

Mount Sinai Medical Center, Miami Beach, Fla., accused the Chicago-based headhunter of failing to adequately investigate the background of a CEO candidate who left the hospital in worse financial shape than ever. In a complaint filed Dec. 20, 2002, the 780-bed teaching hospital alleges that Heidrick misrepresented the qualifications and past job performance of Bruce Perry, who was hired in December 1998 as president and CEO.

Based on the confidential report of the search firm, which was paid $169,000, Perry was hired to replace longtime CEO Fred Hirt, who resigned after a dozen years on the job.The nine-page complaint paints a picture of Perry as a fumbling administrator who predicted in early 2001 that Mount Sinai would turn a profit of $3.5 million. Instead, the hospital lost $64.8 million that year, triggering Perry's dismissal after less than three years on the job.

He was replaced by Steven Sonenreich, the current CEO.The huge loss, the complaint alleged, was caused by "the incompetence of Mr. Perry and his staff" and his "complete inability to run a hospital the size of Mount Sinai Medical Center," which merged with the nearby Miami Heart Institute two years ago.

Now, what does this have to do with the organization finding an NIH postdoc-educated medical informaticist physician with a track record of applied leadership success "not a good fit" to lead clinical IT implementation?

I saw this advertisement today in the April 2008 print issue of "Advance for Health Information Executives" that arrived in my mail today. It is revealing:

Mount Sinai Medical Center ... is currently recruiting IT and informatics professionals to join our dynamic team as we begin hospital-wide implementation of Epic Clinical Systems:

• Director of Medical Informatics
• Director of Clinical Informatics (the difference is quite a mystery to me - ed.)
• Clinical Informaticist
• Clinical IT analyst
• Project Manager
• CIS Systems Administrator
• Database Administrator
• Interface Engineer

Candidates should possess a Bachelor's Degree or equivalent, experience in the healthcare setting, familiarity with clinical applications and systems implementation and support.

Bachelor's degree? Or equivalent? Ten years ago I wrote this ("What Medical Informatics is Not"):

In understanding the role of informaticists, it is important to be aware of another common semantic blur that results in overuse of the term "medical informatics" to refer to any activity involving medicine and computers ... position descriptions such as in these employments ads, with requirements for neither clinical nor medical informatics training or experience, are increasingly seen:

From the Philadelphia Inquirer:

Medical informatics analyst. [Company name] seeks a Medical Informatics Analyst to support resource management and medical affairs in their data analysis needs. Through downloading of MCS database, PC-based analysis of clinical and clinically-relevant financial data will be performed. Qualifications: BA/BS in computer science or related discipline, 3-5 years experience in PC-based data analysis of health care information, knowledge of SAS or similar analysis software, knowledge of mainframe DB2 database architectures, working knowledge of CPT-4 and ICD-9-CM coding."

From an Internet biomedical employment service, Medzilla.com:

[Company name] seeks a Director of Clinical Informatics. Overall coordination of design specifications, implementation and support for all internet/browser based systems. Assurance of continued, reliable and consistent resources and applications to all corporate personnel and external users who may rely upon these systems. Documentation and control of said software systems including package systems and license control if necessary. Provide ongoing maintenance oversight and management support for said systems. Organize and train personnel, both internal and external, who will be using said products. Client contact and development and assist Sales and Marketing as necessary in client presentations. Minimum of a BA. MBA preferred.

Further, I've noted a number of large vendors and even national medical organizations whose so-called "Medical Informatics Directors" had neither clinical backgrounds nor training in medical informatics (nor in information science of any kind). MIS managers, social workers, and clinicians with no more experience than some tinkering with a home Macintosh can be found as "Directors of Medical Informatics" in the (unfortunately) unregulated healthcare IT industry.

It seems little has changed in a decade.

In conclusion, it appears this Miami hospital:

• Does not understand what Medical Informatics is, and what its doctoral-level experts do and can do
• Has little understanding of the major hurdles in clinical IT that can and do commonly occur
• Has little interest in seasoned experts
• Has little interest in the opinions and writings of seasoned experts
• Is apparently pursuing the all-too-common penny wise but pound foolish path of seeking health IT "leaders" with bachelor's degrees or no degrees ("or equivalent"), and without postdoctoral training in Medical Informatics
• Appears to have learned nothing from my visit nor my materials and that of other experts on Health IT difficulties
• Appears to have learned little from its own internal IT and management debacles that led to major economic problems in a highly competitive market where many hospitals have closed.

So be it. It's their hospital. Perhaps they feel there's such a phenomenon as too much talent in an organization. However, I must ask: Is this state-of-the-art hospital management? Can hospitals be run any better than this?

Sadly, the "you can lead a horse to water, but..." metaphor comes to mind.

This professor gives this hospital an "F" on Medical Informatics.

-- SS

---------------------------------------------

9/29/2008 addendum:

See the fifth comment here in my colleagues's post "Update on the NIH Trial to Assess Chelation Therapy" (link) for why I have changed my mind and agree that "I was not the right fit" for this position.

"Singed by the Blogsphere," Academic Doctors Give Up Conflicts of Interest

Everyone now and then we get to comment on good news.

In the New York Times today, Gina Kolata's article was entitled, "Citing Ethics, Some Doctors are Rejecting Industry Pay." The main points were:

With little fanfare, a small number of prominent academic scientists have made a decision that was until recently all but unheard of. They decided to stop accepting payments from food, drug and medical device companies.

No longer will they be paid for speaking at meetings or for sitting on advisory boards. They may still work with companies. It is important, they say, for knowledgeable scientists to help companies draw up and interpret studies. But the work will be pro bono.

The scientists say their decisions were private and made with mixed emotions. In at least one case, the choice resulted in significant financial sacrifice. While the investigators say they do not want to appear superior to their colleagues, they also express relief. At last, they say, when they offer a heartfelt and scientifically reasoned opinion, no one will silently put an asterisk next to their name.

They are part of a group responding to accusations of ethical conflicts inherent in these arrangements, and their decisions repudiate decades of industry influence, says Dr. Jerome P. Kassirer, a professor at the Tufts School of Medicine, who has written a book on conflicts of interest.

Five years ago, 'nobody paid any attention to taking money from industry,' he said, adding: 'They just took it. In some instances, I think people thought they were suckers if they didn’t.'

Now, Dr. Kassirer said, he keeps finding experts who are rejecting the money.

'I don’t think there’s any question that the atmosphere has changed,' Dr. Kassirer said.

He attributes the change to publicity about conflicts and what can be almost a public shaming when researchers’ conflicts are published. 'Finally, it’s gotten to people,' Dr. Kassirer said.

The article only discussed three academicians who have renounced conflict. Yet all three are prominent, so I would like to hope this represents a trend.

The article also told how the people involved began to worry how the conflicts were affecting their thoughts and actions.

Kelly D. Brownell, director of the Rudd Center for Food Policy and Obesity at Yale, made a similar decision. His was to protect his integrity when he began to wonder whether his industry associations were subtly affecting his objectivity. 'The money offers started happening about 20 years ago, at the point that I became a visible person in the field,' Dr. Brownell said.

First it was drug companies developing obesity drugs. Then it was food companies. Eventually, Dr. Brownell said, he began to worry. Were his associations unconsciously affecting his objectivity? He said the money could be substantial. He was offered, for example, $50,000 to be on an advisory board.

'It is easy to offer subtle statements that would favor a drug,' Dr. Brownell said. 'You do it for two reasons. You’ve got a money stream coming in, and you get to like the people who work for the companies. You feel like you’re on a team.'

In many of our previous posts about conflicts of interest, we have quoted people with conflicts indignantly protesting that their financial ties could not possibly have affected their scientific or clinical objectivity. They all believed they were invulnerable to such influence. But common sense, psychological evidence, and the case above suggest that financial entanglements with commercial health care firms cannot help but affect one's thinking.

Also there was this in the NY Times article,

Dr. [Eric P] Winer [Director of the Breast Oncology Center at the Dana-Farber Cancer Institute at Harvard] said. 'I just said enough is enough. And in truth, it has made my life simpler. I no longer debate can I take this, can I not take this. It is simpler when I talk to reporters. It is simpler when I give lectures.'

This is reminiscent of the quote by Joe Collier from the British Medical Journal that I have been fond of using,[Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here and related post here.]

People who have conflicts of interest often find giving clear advice (or opinions) particularly difficult.

Finally, one case described in the NY Times article had particular resonance.

Dr. Peter Libby, chief of cardiovascular medicine at Harvard’s Brigham and Women’s Hospital, said that when he first began receiving offers from drug companies, in the early 1980s, they seemed like a natural reflection of his burgeoning reputation.

'When you start emerging as an opinion leader or as a researcher who has knowledge and expertise, the pharmaceutical industry takes an interest in either having you consult to help them with their research or to speak,' he said.

Dr. Libby wanted to assist. Like many scientists, he feels that it is important for researchers to consult with drug companies to help develop therapies and set up studies. He never owned stock in companies that he consulted for. He always disclosed the fact that he consulted and spoke for companies. And, he added, he thought that he was protected from accusations of favoring any particular company’s products because he consulted for so many.

'I lived safely in that comfort zone for many years,' Dr. Libby said.

Then he was hit with a moment of truth. He had spent four years working without pay to help create a public television series, 'The Mysterious Human Heart.' The project was, he thought, a worthy effort to educate the public about what heart disease was and how to prevent it. He was proud and pleased when the series was broadcast in October.

But to his dismay, bloggers immediately attacked him and the other medical experts who appeared on the programs for having consulted for manufacturers of pharmaceuticals and medical devices, Dr. Libby said, adding: 'They said we were biased. What I thought was four years of public service was impugned.'

'That was a wake-up call for me. I was singed in the blogosphere.'

This year, he made his decision. He would continue speaking at forums sponsored by the pharmaceutical industry and would continue consulting for companies. But he would no longer accept payment.

Since then, Dr. Libby said, company executives and lawyers have asked whether they offended him. Does he have some secret agenda?

His motives are straightforward, he replies. 'I want to speak out about the beliefs I am passionate about regarding prevention and medical advances that I think can reduce disease and save lives,' he said. 'It is not worth it to be under suspicion.'

The blogs that did the singeing were Health Care Renewal (see our post here) and PharmaLot (see Ed Silverman's post here). The PBS show was funded by AstraZeneca and Medtronic. Dr Libby and another physician were content advisors. The show did not disclose that Dr Libby had consulted and served on a speakers' bureau for AstraZeneca, and the other advisor had consulted for Medtronic. I wrote then,

Thus the show's content was influenced by people with significant personal financial relationships with AstraZeneca and Medtronic.

Again, as noted above, there is nothing to suggest that the show's content directly promoted particular products. But by increasing awareness and concern about cardiovascular disease, and emphasizing its treatability, the show could still have served a marketing purpose for companies that make drugs and devices used to treat cardiovascular disease.

Furthermore, although the show did apparently disclose its funding from Medtronic and AstraZeneca, it did not disclose the funding received by some of its medical advisors from the same company.

I suggested,

physicians and researchers who are in a position to influence how the media discusses medicine and health care should, at a minimum, fully and completely disclose any financial arrangements they have with organizations with vested interests affected by such media discussions.

I am very glad that Dr Libby was listening. In my humble opinion, I think he and the two other physicians discussed in Ms Kolata's article made wise decisions to forgo further financial relationships with commercial health care firms. Congratulations to them all. I hope that more physicians and health care academics would also do away with their asterisks.

BLOGCAN - " When a Measurement Becomes a Target, It is no Longer a Valid Measurment"

On the Retired Doc's Thoughts blog, Dr James Gaulte offers some insight into the problems with scorecards for physicians or hospitals, and resulting pay-for-performance (P4P) schemes. The main idea comes from an economist: " Once a measure is made a target for the purpose of conducting policy, it will loose the information content that would qualify it to play such a role." The idea is once a measure becomes a quality or P4P target, it will be gamed, and pursuit of its improvement may lead to unintended consequences that can harm other aspects of quality.

Did Politics Trump MCAT in an Admissions Decision at the University of Florida?

Several stories in the Gainesville (Florida) Sun and the Florida Alligator suggest issues with the leadership of the University of Florida College of Medicine. As first reported in the Sun,

In a move that breaks with the norms established by medical school accreditors, the dean of the University of Florida's College of Medicine has opted to admit a student from a politically connected family, even though the student didn't have the backing of the Medical Selection Committee.

Kone wouldn't name the student, but sources close to the situation identified him as Benjamin Mendelsohn, the son of Dr. Alan Mendelsohn, a Hollywood ophthalmologist and a Republican fundraiser who was a grassroots organizer for Gov. Charlie Crist during his 2006 campaign.

Before Kone took over as dean in May 2007, Gov. Crist sent a letter to UF in February 2007 on Mendelsohn's behalf. The letter, addressed to UF's admissions officer and copied to UF President Bernie Machen, urged UF to admit Mendelsohn to the Junior Honors Medical Program, an accelerated seven-year program that combines bachelor's and medical degrees.

'I have known Benjamin and his family for several years and know that Benjamin's affiliation with the University of Florida will mutually enhance the reputation of both Benjamin and the Medical Program,' Crist's letter states.

In 2006, the Mendelsohn family gave at least $33,257 to political candidates, 94 percent of which went directly to Republicans, according to the Florida Department of State's Division of Elections. Of that money, $1,682 went to Crist, including a $500 donation from Benjamin Mendelsohn himself.

Alan Mendelsohn is a known fundraiser in the medical community. In 2005, he held a fundraiser in his own home where more than 150 physicians raised more than $100,000 for Crist, according to a news release from the Florida Medical Political Action Committee.

The Dean denied that politics influenced his decision.

'I can't even comment that there were any political connections that this person had, but I certainly wasn't influenced by any outside forces,' Kone said Thursday.

'There was no political influence related to this thing,' Kone added in a second interview Thursday night. 'There never will be. There never has been. This was an exceptional student, and I wish to God I could even tell you about (the student's) credentials.'

The Dean also asserted that he had the power to admit the student against the wishes of the committee. It appears, however, that his action may have violated rules set by medical school accreditors.

The move breaks with procedures described by the Liaison Committee on Medical Education, which provides accreditation to UF and medical schools throughout the U.S. and Canada.

'The final responsibility for selecting students to be admitted for medical study must reside with a duly constituted faculty committee,' according to the accrediting body's standards.

Furthermore, the accreditation standards say 'the selection of individual students must not be influenced by any political or financial factors.'

Barbara Barzansky, co-secretary of the Liaison Committee on Medical Education at the American Medical Association in Chicago, said the central role of faculty in admissions is well-established in the medical community.

'I think the standard speaks for itself. It expects that there be a faculty decision around admission,' she said.

'Deans may be under pressure from groups, alums, sometimes the Legislature, depending on the type of school and the location,' she added.

A follow-up in the Gainesville Sun suggested more irregularities in the admissions process. First, it appears the student had never taken the MCAT, a test usually required as a prerequisite to medical school admission.

When the committee considered the 2008 application of Benjamin Mendelsohn, the son of a prominent Republican fundraiser and contributor, Mendelsohn had not taken the Medical College Admissions Test, or MCAT, according to three members of the selection committee and two other sources close to the situation. The MCAT is a standard admissions requirement for regular admission to the program, selection committee members said.

A peculiar memo to medical school administrators, and copied to University President Bernie Machen, suggested that the Dean's actions may have had even murkier origins.

In the e-mail, time-stamped Friday at 10:52 p.m., Kone said Machen's staff did not 'sho(o)t straight' when he met with them, adding that they were not sufficiently courteous to him when they discussed the admissions issue.

'I don't know if it was cowardice, a lack of compassion, or what, but it is symptomatic of why this university is stuck in mediocrity and has been since I left here 13 years ago,' wrote Kone, a former UF student and faculty member.

Kone said that he followed university precedent, 'delivered a great student. Took many bullets for the team. Protected the mother ship.'

Asked whether Kone's reference to protecting the 'mother ship' implied that he was pressured to accept the student, Machen responded Wednesday, 'Please don't make inferences that would be pure conjecture . . . I assure you neither I nor any member of my staff had any involvement in the medical student admission decision.'

Finally, it appears that faculty are disturbed, but fearful of speaking up.

Several faculty members who contacted The Sun said they feared what might happen to their careers if they were publicly critical of the dean's actions. As evidenced by his Friday e-mail, Kone has openly criticized those with whom he disagrees - even Machen's own staff.

Obviously, there are some fuzzy aspects to this story. We may not have heard anything like a final version yet.

What is most disturbing about it, however, are the implications that medical school leadership may have been acting at odds with the institution's mission. In particular, it appears that at least one admission decision may have been affected by politics rather than students' credentials, and faculty are afraid to criticize it. The integrity of the admissions process is fundamental to the integrity of the medical school. Suppression of dissent clashes with the academic ideal of free enquiry. Finally, power within this school seems to have centralized to an unusual extent. Transforming the corporate culture of academic medical institutions into central domination by an "imperial CEO," as is now common in business, is fraught with danger for institutions that are supposed to be about excellent patient care, and discovering the disseminating the truth.

University of Arizona Medical College Faculty Reported on "the Verge of Desperation"

We have posted before (here and here) about how medical schools, despite their name, often fail to pay or otherwise reward faculty to actually teach.

We also noted that one US medical school dean was frank enough to admit that his institution most values faculty members who are "taxpayers," i.e., those who bring in large amounts of what is euphemistically called "external support." On the other hand, faculty who are "welfare recipients," that is, those whose work fails to bring in such support, have at best a "tenuous" position. Since teaching in medical schools almost never brings in substantial "external support," faculty who spend most of their time teaching may be in a "tenuous" position. Similarly, faculty who do research that may not be popular with current research sponsors (now mainly pharmaceutical, biotech, and device companies) may also be in a "tenous" position.

Just recently, the (Tucson) Arizona Daily Star reported on the current situation at the University of Arizona College of Medicine in terms that should be familiar.

Widespread turmoil causing extremely low morale within the University of Arizona College of Medicine 'could destroy the fabric of the college,' says a new report on the situation.

The problems plaguing the medical college have pushed many of the UA's top senior physicians and scientists to the verge of desperation,' said UA faculty Chair Wanda Howell.

The report, which cites 'considerable unrest, demoralization and loss of focus on mission' at the UA medical college, will be presented today at a meeting of the UA Faculty Senate.

What is so greatly demoralizing the faculty?

At the crux of the crisis, according to the report, is the amount of time UA doctors must give to their clinical practices, in order to generate profits, at the sacrifice of academic research and teaching, the report stated.

'As a university medical college, we are supposed to pay more than lip service to research,' Howell said. 'But the doctors are so burdened by their clinical duties, there is absolutely no time for research.'

'This has put many faculty members (teaching physicians) on the verge of desperation.'

In particular,

'After investing 10 hours a day in clinical duties (patient care), they did not understand how they could provide high-quality teaching and build a competitive research program.'

So here is another example of medical school faculty, whose titles imply that they are supposed to teach and conduct other academic pursuits as their main responsibility, instead are expected to "support" their work with "external funds," in this case, derived from their own clinical practice. This leaves them with no time to actually act like faculty.

What is the point of having medical school "faculty" who aren't paid and have no time to teach?

Faculty at no other professional schools would tolerate this. Has anyone ever heard of law, engineering, architecture, accounting, business school faculty who are supposed to "support" their entire salaries by working full-time in their field (or bringing in huge research grants)?

So why are medical faculty supposed to do so?

And what sort of medical education will be provided by faculty who spend 10 hours a day bringing in money for their institutions instead of teaching?

As I wrote before, the call to "show me the money" is mission-hostile management, writ large, of some of our most important, and heretofore revered academic medical institutions.The continuance of such mission-hostile management may yet doom these institutions.

FDA Accuses GSK of Suppressing Clinical Research

We have posted quite a lot about what came to be called the "Avandia" case. This started with the publication in the New England Journal of Medicineby Nissen and Wolski of a meta-analysis focused on cardiac adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) (see post here). One of the most important aspects of this case, in my humble opinion, which we posted about here, but has not been widely discussed, is that it is a case of the suppression of clinical research.

As we posted last year, the Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone completed to date. Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug, most of which have not been published to date. They did eventually appear on a web-site run by GSK. However, this web-site was relatively obscure, and it was not created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link here and our post here).

Nissen and Wolski found it, compiled the results of trials on Avandia, and combined their results with those of the few published trials in their meta-analysis.It is to the credit of Nissen and Wolski to figure out how to do this. It is not to the credit of GSK that they sat on the data from these trials, only put it on this web-site when compelled to do so, did not make any effort to publicize the web-site, and did not publish a meta-analysis done by company scientists that showed qualitatively similar results to that done by Nissen and Wolski (see post here).

Now, as first reported on the PharmaLot and WSJ Health Care blogs, the US Food and Drug Administration (FDA) issued a warning letter to GSK about its suppression of multiple studies about Avandia. (Link here courtesy PharmaLot.)

In particular, the letter asserted,

The inspection found that your firm failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports.

The letter listed numerous studies which GSK failed to report

Furthermore, the letter stated,

Your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted. Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiences in the postmarket reporting for your firms other FDA-approved drugs may exist.

Thus,

The specific violations noted in this letter are serious and may be symptomatic of underlying postmarketing safety reporting failures.

So I guess I wasn't just whistling Dixie when I discussed the Avandia case in terms of suppression of research.

Let's just review why it's bad to suppress research.

First, suppression of research can distort medical decision making, leading to poor decisions for particular patients and thus bad outcomes for some of them. Patients and physicians ideally should base decisions on the best available clinical evidence relevant to the patients' problems. Suppressing evidence that is unfavorable to particular companies' products may lead to use of that product in situations in which it may do no good, or in situations in which it is more likely to produce adverse effects than some alternative. Furthermore, unreasonably delaying or attempting to suppress publication of results of clinical research betrays the trust of the research subjects. Research subjects usually volunteer with the understanding that results of research done on them would be published. Such results could only have been obtained because of their willingness to participate.

At least more cases of attempted suppression of research are now getting the bad publicity they deserve. No we need to fix the problem An obvious solution would be decreasing or abolishing control of clinical research by those with vested interests in the research coming out a certain way.

More About the Cynical World of Drug Reps

We have posted several times about the inside view of the marketing tactics used by pharmaceutical representatives to get physicians to prescribe more drugs provided by former Eli Lilly drup rep Shahram Ahari. Our post about an article he co-wrote with Adriane Fugh-Berman is here. Our post about a recent talk he gave in Boston is here. Ahari has recently testified before the US Congress, and gone on the lecture circuit, providing a new set of juicy quotes to illustrate his main points about the cynical world of at least some drug reps.

• Drug Marketing is Not Education - "The idea that the drug rep is an effective vehicle for disseminating objective science is pure fiction."(1)
• Drug Reps Buy Friendship with Gifts, Et Cetera - Drug reps use "a vast arsenal of gifts, including pens, pads, clipboards, food and drug samples."(1) The job involves "rewarding physicians with gifts and attention for their allegiance to your product and company despite what may be ethically appropriate."(2) Also, "the nature of this business is gift-giving."(2) Ahari's gift budget for meals was $60,000 a year, and that apparently could be exceeded. Regarding the et cetera, "we were the beautiful people." The people he worked with " were all beautiful, vivacious and fun," and included former models and cheerleaders.(3) In an interview available as a video on the Prescription Project blog, Ahari alleged that the drug reps used "sexual tension" to promote their marketing pitch. (That video includes quotes even more to the point than the ones above, so is worth watching directly.)
• Physicians are Not Immune - "Physicians can be influenced like everyone else."(3)

Physicians must remember that the indiscriminate use of the latest and most expensive drugs may not necessarily be good for their patients, and putting the patients' interests first is our prime directive. Yes, many drug reps are nice people and are well-meaning, or at least have convinced themselves that that their intentions are good. But we need to be much more skeptical about their pitches, and remember that their goal is to sell drugs, not to educate or be our friends.

References
1. Hoffer A. An offset to drug industry's sales pitch. Milwaukee Journal-Sentinel, March 12, 2008. Link here.
2. Baram M. Ex-drug sales rep tells all. ABC News. March 14, 2008. Link here.
3. McConville C. Ex-drug salesman: we lured docs with gifts. Boston Herald, March 30, 2008. Link here.

What Influences Advocacy for "Doctor Nurses?"

We have posted many times on the external forces battering primary care physicians (family physicians, general internists, and general pediatricians) in the US. Whenever new fervor for cost cutting arises, the tendency seems to be to call them in as the usual suspects. Thus, primary care doctors have seen their reimbursement lag inflation (see our post here and a post from DB's Medical Rants here), while they are subject to an ever increasing bureaucratic burden aimed at decreasing their supposedly wasteful and overly expensive practices. No wonder fewer and fewer physicians are going into primary care, and more are leaving. They can make much more with less hassle and a "better lifestyle" in other specialties, especially those based on procedures. Yet it is hard to see how our health care system can work with ever fewer, and ultimately no primary care doctors. Health care systems in other countries, which may produce results as good as or better than the US, are much more focused on and supportive of primary care. When no American has his or her own personal physician, who will be able to diagnose their less than obvious problems? Who will be able to manage their inter-related chronic diseases?

Instead of making primary care practice a more workable proposition, however, the current fad is to find other ways to do primary care that do not really involve primary care doctors. For example, an article in the Wall Street Journal addressed the idea of making nurse practitioners get doctorates (but not medical degrees, heaven forfend).

As the shortage of primary-care physicians mounts, the nursing profession is offering a possible solution: the 'doctor nurse.'

More than 200 nursing schools have established or plan to launch doctorate of nursing practice programs to equip graduates with skills the schools say are equivalent to primary-care physicians. The two-year programs, including a one-year residency, create a "hybrid practitioner" with more skills, knowledge and training than a nurse practitioner with a master's degree, says Mary Mundinger, dean of New York's Columbia University School of Nursing. She says DNPs are being trained to have more focus than doctors on coordinating care among many specialists and health-care settings.

One wonders how much nurses will learn from this two year program which might be the shortest doctoral program ever proposed. Primary care physicians, of course, take four years (two mainly classroom, two mainly clinical) to get their degree, and then spend three or more years in post-graduate house-staff clinical training.

Nonetheless, Mundinger seems to imply all that extra training does no good.

A study led by Columbia's Dr. Mundinger and published in the Journal of the American Medical Association in 2000 showed comparable patient outcomes in patients randomly assigned to nurse practitioners and primary-care physicians.

Mundinger partially bases her advocacy of the "Doctor Nurse" on the assumption that nothing can or will be done to make it more possible for doctors to practice effectively in the primary care arena.

Dr. Mundinger, of Columbia, says the primary aim of the DNP is not to usurp the role of the physician, but to deal with the fact that there simply won't be enough of them to care for patients with increasingly complex care needs. As doctors face shrinking insurance reimbursements and rising malpractice-insurance costs, more medical students are forsaking primary care for specialty practices with higher incomes and more predictable hours. As a result, there could be a shortfall ranging from 85,000 to 200,000 primary-care physicians by 2020, according to various estimates.

In addition to training in diagnostic and treatment skills, doctors of nursing practice can have hospital admitting privileges, coordinate care among specialists, help patients with preventive care, evaluate their social and family situations, and manage complex illnesses such as diabetes and heart disease, says Dr. Mundinger, who has been leading the effort behind the National Board of Medical Examiners' planned certification exam.

Note Dr Mundinger's acceptance (the use of the word "fact" above) that the decline of primary care physicians is inevitable. How well two years of training beyond the bachelors degree will prepare these advanced practice nurses to do what used to be done by doctors with at least seven years of training neither Dr Munginger or the article addressed.

In my humble opinion, the solution of our health care problems will not be the "delivery" of "primary care" by people with substantially less training than primary care physicians. The blog DB's Medical Rants has been thoughtfully addressing some of the misconceptions that may underlie this bad idea. One, which DB attributed to "suits" who control but do not really understand health care, is that primary care is basically simple, limited to care of minor acute illnesses and routine prevention based on guidelines. This ignores all the complexity and ambiguity and uncertainty that taking care of the whole patient entails. (See in particular the idea that primary care doctors must deal with the concept of the "long tail.") Primary care really involves dealing with less than obvious, often obscure diagnoses, coordinating management of complex and interrelated chronic illnesses, whose prognoses and response to therapy are difficult to predict, and dealing with intricate biopsychosocial issues. It may be harder and harder for primary care doctors to do these tasks, given that they are not paid to do many of their components, and they are besieged by conflicting and often nonsensical bureaucratic demands. But "doctor nurses" with much less training will find them even harder.

So why does this bad idea continue to gain traction? It may be that the influences behind its advocacy are not as straightforward as they seem. Let us revisit the WSJ article above, and particularly the advocacy of "doctor nurses" by Mary Mundinger.

That name should, in fact, sound familiar to Health Care Renewal readers. While Dr Mundinger is the Dean of the School of Nursing of Columbia University, she has some part-time gigs. In particular, she is on the board of directors of UnitedHealth Group , the large for-profit managed care organization and health insurer. As a director, she is supposed to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] For that loyalty, by 2007 she had received (per the company's 2007 proxy) rights to acquire 345,930 shares of UnitedHealth, and in 2006 was paid $73,750 in cash and stock options valued at $412,575. That level of compensation might inspire some loyalty.

Presumably, it is in the interest of UnitedHealth to hold down what it pays for primary care. In fact, the company, like most other managed care organizations and health insurers, has gone along with the physician payment scheme used by Medicare, and de facto controlled by the shadowy RBRVS Update Committee, which has minimized payments to primary care, but paid for procedures much more lavishly (see post here). Thus Dr Mundinger's advocacy for primary care furnished by "doctor nurses," who would be less well trained and paid than primary care doctors, might serve UnitedHealth Group's interests.

But Dr Mundinger's loyalties seem even more complex than that. She has been known as a particular supporter of the former CEO of UnitedHealth, Dr William McGuire. A 2006 Pulitzer Prize winning article in the Wall Street Journal quoted her thus, "We're so lucky to have Bill. He's brilliant."

In fact, we posted often (see these posts here, here, and here from 2006 with links backward) about the hugely lavish compensation afforded to the Dr McGuire, and how this remuneration stood in stark contrast to the stated mission of UnitedHealth Group:

UnitedHealth Group is a diversified health and well-being company dedicated to making the health care system work better. The company directs its resources into designing products, providing services and applying technologies that:
- Improve access to health and well-being services;
- Simplify the health care experience;
- Promote quality; and,
- Make health care more affordable.

Controversy has swirled over the timing of huge stock option grants given to Dr McGuire (see post here), leading to his resignation in October, 2006 (see post here). More recently, McGuire agreed to pay back some of those options, although that would reportedly leave him with more than $800 million worth of options (see post here).

Dr Mundinger's support of McGuire lead two advisory firms, Institutional Shareholder Services (ISS) Inc. and Proxy Governance Inc, to suggest that institutional investors not vote for Mundinger in the 2006 election for UnitedHealth board members (see post here.) Thus, she seems better known for her personal loyalty to the CEO whom she was supposed to supervise than her unyielding loyalty to UnitedHealth Group's stockholders.

To make things even more complex, Mundinger also is a member of the boards of directors of Gentiva Health Services, and Cell Therapeutics Inc. Gentiva Health Services provides home care services. Cell Therapeutics Inc is a biotechnology company that develops cancer treatments. Per its 2008 proxy statement, Dr Mundinger received $127,531 in total compensation from Gentiva Health Services in 2007, and has received options to purchase 10,090 shares of its stock. Per its 2007 proxy statement, Dr Mundinger received $92,865 in total compensation from Cell Therapeutics Inc in 2006, and has received options to purchase 23,750 shares of its stock. Thus she has reason to have unyielding loyalty to the stockholders of these two companies. However, these companies' interests, to maximize profits from home care services, and to maximize profits from cancer treatments, conflict with the interests of the UnitedHealth Group to minimize what it spends paying for these services and treatments.

So trying to figure out the influences behind Dr Mundinger's prominent advocacy of "doctor nurses" is well nigh impossible. Dr Mundinger has an amazingly complex set of conflicts of interest. So where do her interests lie? - Improving clinical care and promoting clinical science and teaching (the academic mission of her nursing school)? Increasing UnitedHealth Group's profits by decreasing its payments for health care? Increasing Gentiva Health Services' profits by increasing the payments it gets for home health services? Increasing Cell Therapeutics Inc's profits by increasing what it gets paid for cancer therapies?

And that is, as we have said before, the curse of conflicts of interest in health care. Conflicts lead to confused thought, speech, and action. One cannot tell what interests lie behind the speech and actions of the conflicted. So health care policy advocacy by the conflicted, rather than leading to better health care for all, just leaves us in a fog of doubt and confusion.

But financial ties to various industries, regardless of the conflicts they produce, fuel the imperial pretensions of their academic health care institutions' leadership (see post here). So the universities and their leaders will not give up their conflicts without quite a fight. But the confusion about clinical care, about research, about health policy that swirls out of the ever more pervasive web of conflicts in health care means it's time for that fight to start.

Everything that Rises Must Converge: University of Texas High Living Executives and Eli Lilly's Marketing of Zyprexa

Recently we posted about some dubious practices at the University of Texas Southwestern Medical Center that seemed to contradict this proud academic medical institution's mission. First, there was the case of the "A-list" of local notables who were to have special access, including enhanced access to physicians (see posts here and here). Then, there was the report of how medical center executives seemed to be living the high life funded by charitable donors (see post here).

Also, more than a year ago, we posted about how Eli Lilly and Co. was alleged to have marketed its atypical anti-psychotic Zyprexa (olanzapine) to minimize its major side-effects, including frequent weight gain and the development of diabetes, and how the company was accused of marketing the drug "off-label" for medical problems and in situations for which the drug had not been approved by the US Food and Drug Administration. Since this story has since got a lot of coverage in the media and blogs, we have not returned to it for a while.

Now I have appeared to be guilty of a non sequitur. What is the possible connection between these two issues, other than they both seem to involve questionable decisions by leaders of large health care organizations?

Just wait...

Many media outlets have reported how Eli Lilly is under fire for its marketing of Zyprexa. Last month the NY Times reported on a memo that suggested the company's incoming president "appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators." That article noted that the company is also "under federal criminal investigation for the way it promoted Zyprexa and played down the drug's risks to doctors." Many media outlets reported late last month that the company settled a lawsuit by the state of Alaska that again charged that the company minimized Zyprexa's side-effects (e.g., see the Wall Street Journal here.)

The Wall Street Journal just reported that one large Eli Lilly shareholder was increasingly discontented by the company's current management, presumably at least in part due to how it marketed Zyprexa. Now read closely, and you will see that my hands never leave my arms...

California's public-employee pension fund plans to withhold votes for three Eli Lilly & Co. directors up for re-election next month, citing a lagging stock price and poor corporate governance.

The California Public Employees' Retirement System, or Calpers, said Thursday it will withhold votes for John Lechleiter, a long-time Lilly executive who is set to become chief executive next week. He has been on the drug maker's board since 2005.

In addition, Calpers will withhold votes for directors Alfred Gilman, provost at University of Texas Southwestern Medical Center in Dallas; and Karen Horn, a retired executive with Marsh Inc. Mr. Gilman has been a Lilly director since 1995 and Ms. Horn has been director since 1987.

'It was on their watch that Eli Lilly experienced severe stock underperformance, poor corporate governance practices, and was unresponsive to shareowners,' Russell Read, Calpers' chief investment officer, said in a press release.

Lilly said in a written statement it disagreed with Calpers' assessment of the three directors as unsupportive of and unresponsive to shareholders.

Gotcha...

So a director of Eli Lilly that was accused of responsibility for the company's poor performance, poor performance which presumably included its mis-marketing of Zyprexa, also turns out to be responsible for the management of the University of Texas Southwestern Medical Center, currently under fire for maintaining an "A-list" of favored patients, and letting its top executives live the high life on donated funds, practices that go against its mission.

This seems like a good illustration of how conflicts of interest affecting health care leaders may not be good for any of the organizations to which these leaders simultaneously owe allegiance. An academic medical institutional leader who is also a director of a public for-profit company may not be a particularly good guardian of share-holders' interests. A director of a for-profit health care corporation who also is the leader of an academic medical institution may not be a particularly good guardian of that institution's values.

Of course, conflicts like these benefit the conflicted individual, who gets power and prestige from both allegiances, plus, of course, a lot of money. (Note that according to Eli Lilly's 2008 proxy statement, Dr Gilman got $281,448 total compensation in 2007 to serve as director. In addition, Dr Gilman now owns 17,159 shares of Eli Lilly stock, currently valued at $51.76 per share, see Google Finance, for a total value of $888,150.) The conflicted individual in such a situation might well feel himself or herself to be among the power elite. And the conflicted individual in a case like this might be in a good position to help out his or her buddies in both the corporate and academic medical hierarchies.

But in my humble opinion, such conflicted leaders are not good for patients, for academia, for physicians, or for stock-holders, for that matter.

If we are really worried about the conflicts of interest created when physician trainees get pens or coffee mugs with company logos from drug companies, or practicing physicians get pizza lunches for their office staffs from pharmaceutical representatives, (see post here) then we should really worry when leaders of academic medical institutions serve on the board of directors of large health care corporations.

BLOGSCAN - GSK Lawyers Have Paxil Video Taken Down

On the Seroxat Sufferers Blog, Robert Fiddaman posted about how legal threats from attorneys for GlaxoSmithKline forced him to take down a video from YouTube which contrasted statements by Dr Alastair Benbow about the Seroxat (Paxil, paroxetine, made by GlaxoSmithKline) controversy with other versions of reality from the news media and the MHRA report. (See our most recent post here about how the MHRA concluded that GSK suppressed clinical research data unfavorable to its product.)

Also, on the Scientific Misconduct Blog, Dr Aubrey Blumsohn perceptively comments on GSK's attack on Fiddaman here. And on the Clinical Psychology and Psychiatry Blog, the anonymous blogger sagely opines here.

ADDENDUM (4 April, 2007) - Again on the Scientific Misconduct Blog, Dr Blumsohn surveyed the considerable discussion in the blogsphere of these events.

Smoke Alarm: Tobacco Funding of Medical Research at Reputable Medical Schools May be Prevalent

We recently posted about a controversial study of using CT scans to screen for lung cancer that turned out to have been partially sponsored by a tobacco company. Even though we have written quite a bit about conflicts of interest, this surprised even me, since the conflicts of interest presented by financial relationships with tobacco companies seem so blatantly risky that I would have thought few physicians or medical researchers would dare contemplate them. It looks like even having blogged on Health Care Renewal for several years, I am still too naive.

For example, the Boston Globe just reported on funding of medical research in the Boston area just by tobacco company Philip Morris USA, just spun off from Altria Group Inc.

The nation's largest cigarette maker has paid for scientific research at four Massachusetts universities since 2000....

Philip Morris USA, which makes Marlboro and other top-selling cigarette lines, gave grants to scientists at Boston University, Harvard University, the Massachusetts Institute of Technology, and the University of Massachusetts, company spokesman David M. Sylvia said Friday.

The research supported by the company touched on conditions such as heart disease and cancer that are linked to smoking.

Funding went to Boston University.

BU's acceptance of research grants from Philip Morris was first disclosed Thursday in The Daily Free Press, a student newspaper at the university.

At BU, one recipient, Dr. Douglas Faller, is a longtime professor and director of the BU Cancer Center. According to a document detailing work at the university's Women's Health Interdisciplinary Research Center, Faller received $268,759 from Philip Morris to investigate a cancer drug.

Reached at his home late Friday, Faller deferred to university officials for comment.

Funding went to Harvard, although it has decreased since Harvard banned new tobacco funding of research in 2004.

At Harvard Medical School, researchers were ordered to stop pursuing tobacco-industry grants in July 2004. 'The policy did, however, allow those few researchers who had ongoing projects funded by those entities to complete them,' Margaret Dale, dean for faculty and research integrity at Harvard Medical School, said in a statement released Friday by a university spokesman.

Funding previously went to University of Massachusetts Medical Center, but the institution does not currently get tobacco funding.

A UMass Medical School spokeswoman said that the school does not currently have any research supported by tobacco companies and that it had accepted 'no more than' $2 million from the industry over the past decade.

No Philip Morris funding went to Tufts University School of Medicine, but the school did admit to receiving money from another tobacco company.

The Tufts University School of Medicine received no Philip Morris grants, but a school spokeswoman said that one laboratory there had received a grant in 2006 from a tobacco company.

The argument against funding of clinical research by pharmaceutical, biotechnology and medical device companies has been that such companies often try to exert influence, subtle or overt, that might bias the research to favor their products, or even suppress research that shows their products in a bad light. Such influence could adversely affect the advancement of science, and decision making by physicians and patients who accept the published research as unbiased. Such influence also breaks the trust of research subjects who were told that they were volunteering to advance science and health care.

But at least pharmaceutical, biotechnology, and device companies make products intended to help patients more than they harm them.

Tobacco products obviously pose serious health risks, and have no health benefits to counterbalance them. So the bias that could result from tobacco companies' sponsorship of research could be much worse for science, for medical decision making, and for research subjects than bias resulting from pharma, biotech, or device companies' research sponsorship.

Yet some medical schools seem to push their faculty so hard to get "external research support" that they do not mind if such support comes from tobacco companies.

Kudos to Harvard, though, for trying to cut back.

No medical school administrator nor researcher willing to be quoted by the Boston Globe reporter dealt directly with why tobacco company research support might not be a good idea. For example,

In a statement issued Friday evening, the provost of BU's medical campus, Dr. Karen Antman, said the school had received $3.99 million from Philip Morris during the past decade and devoted it to the study of tobacco-related diseases.

'We adhere to the highest ethical conduct in research and pursue funding from a variety of sources for unrestricted medical research,' Antman said in the statement. 'Our research is conducted and the results are assessed against the standard benchmarks that apply to any research.'

Again, the issue is that a researcher getting "unrestricted" research funding, funding that might be keeping his or her academic career alive, might naturally feel some gratitude for the funding, and consequently might unconsciously be less likely to criticize his or her funding source or its products than otherwise. Of course, the more the researcher might need future funding from this sponsor, the more likely would be a conscious sense of obligation to be nice to that sponsor. Furthermore, even "unrestricted" funding may open up some lines of communication between the sponsor and the researcher which the sponsor could use to further increase its influence.

Also, the tobacco companies surely are not spending money to support research out of pure altruism,

'Their interest now is to try to convince the public that they are truly concerned companies and that they care enough to fund important research at reputable institutions,' said Dr. Michael Siegel, a Boston University School of Public Health researcher who has extensively studied the tobacco industry. 'And, they're using the good name of these institutions to try to bolster their own scientific and public credibility.'

That seemed to be working, as demonstrated by this seemingly self-contradictory quote from a Massachusetts Institute of Technology researcher:

'As there were no strings attached in the application process I had no qualms in applying for this funding,' Rami Tzafriri, of MIT, said in an e-mail. 'In retrospect I can say that the whole process was very professional and friendly and that under similar circumstances I would apply for such funding again. Funding for research is essential, but unfortunately scarce. So any source that does not compromise my independence is welcome.'

On the other hand,

'Taking money from the tobacco industry to conduct scientific research is like the DA taking money from the Mafia to conduct investigations of crime,' said Gregory Connolly, a Harvard School of Public Health professor and former director of the Massachusetts Tobacco Control Program.

Indeed. It would strongly be in society's interest to find a way to wean academic medical institutions from their addiction to research dollars proffered by those with something to sell other than science and improving health care.

ADDENDUM (2 April, 2008) - See also comments on the Effect Measure blog.

Taken for saps in the Trash Industry: Garbage in, garbage out? (Or is it "Garbage Out, No Garbage In?")

If large IT companies can't even get software for hauling garbage correct, why is there so much faith that they can automate healthcare?

While not directly related to healthcare, I see many familiar themes here that I've also seen in healthcare. Could this be the future of enterprise healthcare IT as well? Garbage in, garbage out? (Or is it "Garbage Out, No Garbage In?") Also, since healthcare organizations are choosing this same vendor (including some very prominent ones), this story is of potential importance to our profession.

If the details in this story are even close to factual, SAP would have violated just about every fundamental principle of good software design and resilience engineering, social informatics, and common sense.

I think of stories like these as cautionary tales. They might help counterbalance the mass exuberance regarding complex, expensive enterprise health IT. There certainly are precedents. For example, the essay "Shhhhh! 10 Secrets the EHR Companies Don't Want You to Know" contains familiar themes relevant to the trashy software story below:

SAP sued by trash hauler Waste Management
By Linda Loyd
Philadelphia Inquirer Staff Writer
March 28, 2008

The nation's largest hauler of garbage is suing software developer SAP America Inc., of Newtown Square [PA, near Philadelphia - ed.], and its parent, SAP AG of Germany, alleging fraud and false representations about waste-and-recycling software that it called "a complete failure."

Waste Management Inc., of Houston, is seeking to recover more than $100 million in expenses, plus unspecified punitive damages.

That isn't exactly trash money.

... The suit was filed last week in the Harris County, Texas, District Court. SAP is the world's largest business-software company. Its Americas division employs more than 2,000 in Delaware County.

I wonder how much of SAP America's development and programming work is outsourced to foreign countries (Germany, China, India etc.)? The common belief in this industry, it seems, is that people in foreign lands can be remotely managed in writing extremely complex software for managing extremely complex businesses in other countries (and, in the case of healthcare, entire professions) whose cultures they probably do not understand, since all businesses are just collections of "processes" that can be catalogued and automated like a global Model-T assembly line.

In 2005, Waste Management was looking for new revenue-management software to handle such tasks as billing, collections, pricing and new-customer setup, the lawsuit said.

SAP said its waste-and-recycling software was a "tested, proven, out-of-the-box solution" that could be rapidly implemented without need for any customization, the suit said.

Alert! In this paragraph we see violations of the major tenets of software engineering, resilience engineering, and common sense (common, at least, to anyone not infected with greed and the 'Silver Bullet-based Religion of IT-Enabled Transformation.")

The Waste Management IT personnel who fell for the "Plug and Play" lines should themselves be fired. No complex software is ever "out of the box" when ported from environment A to environment B. To say so, or to believe so, is bull. (In healthcare, that holds even for different medical specialties and service lines even within one organization.)

These representations were false because a "U.S. version" of the software had never been tested at a U.S. company, according to the court filing. Before 2005, it said, the software had been licensed to "a limited number" of small European firms.

And herein is the fatal flaw that is the "wage of hyperconfidence in computers" as all-powerful "solutions" to the world's business and professional problems. Europe, America ... trash hauling is trash hauling, no? Medicine is just a business like any other, right? After all, how hard can it be to accomplish nuclear fission on your kitchen table if you have all the right components?

SAP purported the software would save "hundreds of millions of dollars in increased efficiencies and revenue," the suit said.

Just as similar enterprise software will "revolutionize healthcare?"

Instead, it was "nothing more than beta software - software still in development and utterly incapable of running the operations of an American waste and recycling company," it said.

Waste Management said SAP presented "fake mock-up simulations," although the demonstrations were represented to be the actual software.

Dear Waste Management IT and management personnel,

This is the oldest trick in the book. (I could have smoked this out in ten minutes if you'd let me. Maybe you should have read my website on health IT problems?)

Waste Management said senior SAP executives, including SAP America president and chief executive officer Bill McDermott, participated in the "rigged and manipulated" demonstrations. "These fake product demonstrations occurred at numerous locations and on many occasions during an eight-month time period in 2005," court papers said.

Waste Management signed a licensing pact with SAP on Oct. 3, 2005. "Almost immediately the SAP implementation team discovered significant 'gaps' between the software's actual functionality and Waste Management's business requirements," the complaint said.

"Gaps?" Put more succinctly, it seems the software was garbage. (When something goes wrong, always blame the computer...)

In addition, the suit alleged, SAP originally promised that a pilot phase in New Mexico would be running by Dec. 15, 2006, but "it is not even close to being completed today."

Could this reflect SAP's own "irrational exuberance" about their IT, or was it simply a lie to get a contract signed, real, quality deliverables be damned?

Waste Management said it was seeking recovery of more than $100 million in project expenses "as well as the savings and benefits that the SAP software was promised to deliver."

They may get the former (i.e., money), but lots of luck on getting the latter.

Finally, if anyone on the plaintiff side wants to hire me as a consultant familiar with IT malfunctions and malfeasance, I'm ready and willing.

-- SS