Yale Settles

The parade of settlements continues. The basics of this story were reported by AP:

Yale University has agreed to pay $7.6 million to resolve allegations that it broke the law by mismanaging federally funded research grants, federal authorities announced Tuesday.

The civil settlement with the government resolves allegations that some Yale researchers at times charged a federal grant account for costs unrelated to grant objectives. The government also alleged the researchers wrongfully charged 100 percent of their summer activity to grants when the researchers spent significant time on unrelated work.

At issue were allegations that grant money was used to cover costs that did not relate to the objectives of the specific grant involved.

Researchers allegedly were motivated to carry out wrongful transfers when the grant was near its expiration date and they needed to spend down the remaining grant funds, authorities said. Regulations require that unspent grant funds be returned to the government.

The wrongful salary charges stemmed from the fact that researchers are not paid their academic-year salary by Yale during the summer, authorities said. The only salary received by the researchers during the summer came from what they charged to federal grants, prosecutors said.

A bit of the news coverage focused on why these problems may have occurred. The Yale Daily News reported:

The thicket of subpoenas, audits and new compliance policies was a source of strain and sometimes a point of contention between faculty members and administrators, who sometimes tended to see the burden of improving grant accounting as resting on each other.

“I recognize that this investigation has been stressful for many members of our faculty and staff, and I also recognize that federal regulations are sometimes burdensome,” University President Richard Levin said in a letter to faculty and staff Tuesday.

Also, the New Haven Register reported:

When asked if any researchers were disciplined, Yale spokesman Tom Conroy said, 'the focus of the investigation was Yale’s grant accounting systems and controls, not actions by particular individuals. Yale now has in place a comprehensive training program for faculty and staff on relevant aspects of federal grant accounting.'

When I first got involved in the world of US government grants as a medical school faculty member, I was told that I, as the Principal Investigator, would be responsible for the scientific conduct of the project. On the other hand, I was told that the organization receiving the grant, e.g., usually a university or research institute, would be responsible for the fiscal conduct of the grant. Therefore, I wonder why there was "confusion" in this case about who was supposed to do grant accounting. Someone correct me if this has changed, but I thought that in this case, it was the university administrators who were supposed to do the grant accounting, not the faculty. (Note that the university got the grants, not the faculty members as individuals.)

In that light, the statement of the Yale spokesman is illuminating. According to him, no individual was responsible for the problem. The fault rested with the "grant accounting system and controls."

That reminds me of the 1960s, when some hippies were heard to mutter, "it's the system, man, that's bad."

Of course, the "system" did not grow like a tree, but was created by people. So if the system's users were not at fault, then its designers and maintainers were.

However, it seems that when something goes wrong in a health care organization, it is never the administrators and executives who are at fault. Sometimes a low-level bureaucrat may be scapegoated. But the fearless leaders can do no wrong. They are never to blame. They are never punished.

I submit that it is this impunity, this lack of responsibility that is a fundamental problem with health care today. Doctors are often accused of assuming god-like authority. We doctors, unfortunately, are too often responsible for what has gone wrong. But at least there is some redress against doctors when they act in their clinical capacity. Doctors are sued for malpractice (sometimes unfairly, sometimes with good reason.) Doctors are subject to professional disciplinary boards, and can have their licenses suspended or revoked

But when do university, hospital, or corporate executives ever pay a penalty for mistakes, or even malfeasance?

As long as they have no incentive not to do wrong, they will continue to do so.

Is Nothing Sacred? - Questions of Commercial Influence on the Awarding of the Nobel Prize for Medicine

Many news outlets, but few in the US, have reported concerns about the integrity of the Nobel Prize in Physiology or Medicine. As reported by the Toronto Star,

Swedish anti-corruption agents are investigating allegations that pharmaceutical giant AstraZeneca influenced the awarding of this year's Nobel Prize in medicine.

'I have formally instigated, or started, a criminal investigation,' Swedish anti-corruption prosecutor Nils-Erik Schulz told the Star in a telephone interview from Stockholm yesterday.

Schulz's investigation was sparked by claims in the European press that AstraZeneca's sponsorship of two Nobel promotional companies – Nobel Media and Nobel Web – influenced the choice for this year's prize in medicine. As well, two Swedish academics on the committee have close ties to AstraZeneca – one sits on the company's board of directors, while the other was a former consultant to the pharmaceutical company.

Part of the Nobel Prize in Physiology or Medicine was awarded this fall to Harald zur Hausen, a German scientist who discovered the links between human papilloma viruses and cervical cancer. The discovery could be a financial bonanza for AstraZeneca, which holds the patents on ingredients in the vaccines used to fight the viruses.

AstraZeneca stands to make millions from Gardasil, made by Merck, as well as GlaxoSmithKline's Cervarix, thanks to patents it holds.

Not surprisingly, AstraZeneca and the Nobel Foundation denied doing anything wrong,

'Because the Nobel Committee of Karolinska Institute, and not the Nobel companies, elects candidates for the prize, AstraZeneca will not be able to influence who will be awarded the Nobel Prize, nor do we ever seek to,' Laura Woodin, manager of media relations for AstraZeneca in the U.S., said in a statement to the Star. Nobel Foundation director Michael Sohlman was equally adamant about the strict separation between fundraising and the selection of Nobel laureates.

'The foundation has 100 per cent confidence in the integrity of the Nobel Assembly at the Karolinska Institute, as we have in the other prize-awarding institutes,' Sohlman said in a telephone interview from Stockholm yesterday.

In my humble opinion, both these denials begged the question. At the least, it appears that at least one member of the committee that awards the prize in medicine is on the board of directors of AstraZeneca, a pharmaceutical company. Specifically, "Nobel Assembly member Bo Angelin sits on the company's board of directors, which pays $50,000 (Cdn) a year." As we have discussed in the past, beyond being remunerative, sitting on the board of directors of a for-profit company implies a duty to the stock-holders to maximize the profits of the company. Such a duty could create a conflict for someone who also votes on the awarding of a lucrative and extremely prestigious prize for medical scientific discoveries that could relate to the marketing of such a company's products. The presence of Dr Angelin on the committee which chose the Nobel Prize winners suggests at least the possibility that commercial concerns could affect the selection process. Furthermore, his presence suggests that there is no prohibition of directors of for-profit health care corporations from sitting on this committee. There may have been other committee members with other conflicts that further suggests commercial influence on the awarding of this most prestigious prize.

Is nothing sacred? It appears that the web of conflicts of interest in medicine and health care has spread to even the most renowned of its institutions. And now we must wonder whether even the Nobel Prize has been turned into a marketing opportunity.

See also comments by David Williams on the Health Business Blog, and the anonymous blogger on PharmaGossip.

Who Leads in Intellectually Challenged Responses to Medical Informatics Backgrounds, The U.S. or Europe?

This is another personal account of rather strange experiences in the field of Medical Informatics, whereby I sometimes feel I am in a parallel world known in the comics as Htrae, Earth spelled backwards (see my earlier post here on the "parallel" worlds of medicine vs. IT).

I feel case accounts such as this, while admittedly anecdotal, may illuminate larger issues in medicine, healthcare information technology and leadership issues in both domains.

At "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" I noted the appointment of a new Chief Information Officer for Health, a new leader for the massively troubled, multibillion dollar UK national electronic medical records program Connecting for Health (CfH).

The new leader had been a CIO at a candy and soft drink company as well as a gas and power utility. The are certainly fine qualifications to lead a national medical informatics initiative:

Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

The newly appointed Director of Program and System Delivery has a like background. Simply stunning. A multi-billion dollar EMR program on the verge of cancellation, with a history of ineffective leadership by non medical IT personnel, tries to redeem itself via the same old tired script despite ample availability of materials that suggest better ways, e.g. here.

Based on this type of story and my own anecdotal experiences, I am beginning to wonder if perhaps Europe has more dysfunctional attitudes regarding medical informatics expertise than the U.S.

For example, I'd personally been told several years ago that "there's nothing in my resume of value to a clinical research organization" by a British Sr. VP for Biometrics and Data Management of Europe-based CRO Icon Clinical who refused to speak with me directly (see "CRO's: we don't need Medical Informatics here.")

I've been told by a European GSK VP of Informatics & Knowledge Management who also refused to speak with me directly - even after an unsolicited call, interview and highly positive recommendation by GSK's own prestigious British retained recruitment firm - that my background was unsuitable for pharma informatics (despite my prior leadership role at Merck Research Labs - an American company!) This was because such work required someone with “an extensive CS background to write algorithms to solve business problems" (see my post "GSK, Avandia and Medical Informatics: More on Why Pharma Fails" for a series of significant questions raised by this information technologist's misinformed and profoundly tunnel-visioned view of Medical Informatics).

From another Europe-based clinical research organization: "Just wanted to follow up with you about the [informatics management] position. They sent us an e-mail today communicating that you are a great candidate but just a little too heavy on the Informatics side for this position."

I won't even attempt to parse that bizarre, duncical response.

Most recently, it happened again.

I've been told by another Euro company that I don't have enough experience.

I received an unsolicited message from Philips Research recruiting:

From: "Blimberg, Paul"
Date: 10/20/2008 03:39PM
Subject: Philips Research

Hello Scott,

We are presently conducting a search for viable candidates for our Open Head of Biomedical Research Informatics position (see attached). It was my hope that you may be able to recommend possible referrals or perhaps be interested yourself? Please contact me to discuss further.

Best Regards,

Paul Blimberg
Sourcing Team Lead - N.A.
Philips Shared Services - Recruiting

In the job description:

Title: Senior Director and Research Department Head
Group: Biomedical Informatics Research

The department performs research in areas of “representation, storage, retrieval, presentation, sharing, and optimal use of biomedical data, information and knowledge for problem solving and clinical decision-making”. Specifically, the research concentrates on clinical decision support. That is, the design, development, validation and evaluation of computer-supported software applications and solutions that unify knowledge discovery with engineering methods for deployment in the healthcare environment.

Responsibilities included:

• Local Line management of technical professionals (MD/PhD/MS level);Program project management: project content, resources, staffing, funding, etc;
• Project renewal for value creation;
• Technical interaction and visibility in regional technical and professional organizations;
• Develop and manage research relationships with universities, scientific institutions, government contracts, etc.
• Establishing and expanding the IP portfolio for biomedical informatics and clinical decision support;
• Networking worldwide with Philips Research group leaders, project leaders and researchers to set the agenda and manage the relationships that will solidify and grow the CDS research activities.

Desired Candidate Background included:

• Experience in leading technical research in biomedicine driven towards clinical & business outcomes;
• Line management and strategy development skills;
• Technical recognition in field of expertise;
• PhD or equivalent in Biomedical Informatics or Biomedical Engineering with healthcare organizational experience; MD a significant plus;
• PhD in Computer Science will be considered if accompanied by significant work experience in healthcare or clinical medicine.

This was a good fit to my background. I wrote back:

Attached is my CV towards this position. I am a very close fit to its requirements, and in fact a key issue is my background not just in medicine and IT, but in electronics and telecommunications as well. I converse with technology professionals as easily as with medical professionals and executives, a skill that I believe is uncommon.

I proceeded to have an intensive telephone screen with the Philips recruiter, who then said he would pass along my CV to the hiring manager and team and that I would likely hear back in a few days or a week.

I have heard that line before, I thought.

After two weeks I heard nothing. I sent followup emails and voicemails on several occasions, still nothing in reply.

I had a strong feeling that the reason was going to be another case example from the "Medical Informatics Theater of the Absurd."

I finally sent a message expressing that I was "troubled" about not hearing back, and got the following reply:

From: "Blimberg, Paul"
Date: 11/12/2008 02:06PM
Subject: RE: Philips Research

Hi Scott,

We are still recruiting candidates for the role. I did also receive feedback from the team indicating that they would like for me to identify additional candidates with more established industry experience. Unfortunately, They will not continue to consider yourself and a few other candidates I have recently presented. So the quest continues.

As a former hiring manager in Big Pharma providing advanced informatics support for pharmaceutical research and development to 6,000 scientists worldwide, as well as being clinical IT project leader in an international collaboration with a Middle Eastern oil-producing country as well as at a number of large academic and non academic medical centers, I'm not sure what "more established industry experience" in informatics means ...

In any case, Philips was telling me I did not have enough experience, based on a piece of paper; the hiring manager or staff made this decision without any direct communications. It's not as if people with formal Medical Informatics backgrounds are falling out of the woodwork ...

I am beginning to sense a pattern.

What was the background of the hiring manager?

B.Sc. Honours degree in Physics and Music and a Ph.D. in the measurement of blood flow with ultrasound from University College Cardiff, U.K. ... was an ATL Ultrasound Technical Fellow and is a Fellow of the American Institute of Ultrasound in Medicine ... joined Research in North America in 2002 as Department Head in Healthcare Systems and IT to focus existing competencies in medical information technology ...

Notably lacking: formal credentials in medicine or Medical Informatics.

It's their company, but that doesn't stop me from asking probing questions. Being an inquisitive person, I wrote to the CEO of Philips Research, Peter Wierenga, PhD. After a short summary of the events above, I wrote:

Dear Dr Wierenga,

I note your opinion at this press release :

Peter Wierenga, CEO of Philips Research adds: “ Talent is one of the essential drivers of our innovative power. Without talent there is no innovation."

I tend to agree.

My question to you is: how can talent be evaluated from a paper CV and an HR conversation, without any direct contact between the hiring manager (presumably a domain expert) and a potential employee?

I claim it cannot, and will make the claim - in my opinion - that your personnel who believe it can be, as evidenced by their not even talking to several candidates with backgrounds similar to my own, may be causing harm to your company and to U.S. informatics efforts.

I await an answer to my question.

(I am assuming, of course, that what I was told was straightforward, and that there is no "sweetheart candidate" - with a sham recruitment process conducted to show that required internal hiring procedures were followed. This happens ... however, I will assume straightforwardness. I report, you decide.)

As bad as U.S. companies have been regarding informatics expertise, anecdotally the most intellectually challenged responses to medical informatics backgrounds I've experienced have indeed come from European companies. Ironically, the Saudis thought more highly of the field than the supposedly refined "from each according to their ability" Europeans, in my experiences as co-PI of informatics in the Saudi-Yale collaboration in clinical genetics.

I am also beginning to sense that the UK's massive problems in its Connecting For Health national EMR initiative may not be an entirely nonlinear phenomenon explainable only by chaos theory.

-- SS



Htrae!

For a Few Dollars More: Academic Ideals Go Up in Smoke

In the New York Times was a report on an unusual research program at Virginia Commonwealth University:

a contract with extremely restrictive terms that the university signed in 2006 to do research for Philip Morris USA, the nation’s largest tobacco company and a unit of Altria Group.

The contract bars professors from publishing the results of their studies, or even talking about them, without Philip Morris’s permission. If 'a third party,' including news organizations, asks about the agreement, university officials have to decline to comment and tell the company. Nearly all patent and other intellectual property rights go to the company, not the university or its professors.

The contract appeared to contradict the university's research policies:

Virginia Commonwealth’s guidelines for industry-sponsored research state, 'University faculty and students must be free to publish their results.' The guidelines also say the university must retain all patent and other intellectual property rights from sponsored research.

Under the agreement, though, Philip Morris alone decides whether the researchers can publish because the contract defines 'without limitation all work product or other material created by V.C.U.' as proprietary information belonging to the company.

Ms Saul asked Francis L Macrina, vice president for research at VCU, to explain the apparent discrepancies between the contract and the university's policies:

'There is restrictive language in here,' said Francis L. Macrina, Virginia Commonwealth’s vice president for research, who acknowledged that many of the provisions violated the university’s guidelines for industry-sponsored research. 'In the end, it was language we thought we could agree to. It’s a balancing act.'

Also,

'These restrictive clauses seek to protect the rights and interests of multiple parties in the agreement,' Dr. Macrina said, pointing out that Virginia Commonwealth scientists would be working with other researchers.

And,

Dr. Macrina also defended the requirement that the university decline comment and tell the company if asked about the agreement by news organizations and other third parties.

'Language like that occurs in agreements like this because the sponsor wants to be sure there are no slip-ups, that things will not be released inadvertently,' he said.

A Philip Morris executive, Rick Solana, "senior vice president for research and technology," rationalized the secrecy provisions thus,

Dr. Solana also said the contract represented a new focus on developing tobacco products with reduced risks, a shift in strategy in underwriting university research that requires more confidentiality to protect the corporation’s intellectual property rights. And he said Philip Morris had similar arrangements with other universities — although he declined to say how many or which ones.

And he noted that maybe under certain circumstances the company would allow university researchers to publish:

saying that once the company determined that its competitive interests were protected, it could permit researchers to publish.

'We have to start out with is anyone’s intellectual property going to be compromised?' Dr. Solana said. 'Once the intellectual property is protected, then it’s usually O.K. to publish.'

'Something being proprietary does not mean something cannot be published. We try to be very supportive in the health area of work being published.'

What's wrong with all this? Where do I start?

First of all, the fundamental mission of the university is to seek and disseminate the truth. Letting a research sponsor control whether research can be published, and making secret research agreements with research sponsors violate this fundamental mission. Perhaps under some special circumstances, such as when national security is involved, exceptions could be made. But obviously doing research for a tobacco company does not involve national security.

It is painful to see a university vice president for research verbally squirming to try to justify signing a contract that so fundamentally violates the university's mission.

Second of all, the research was being done on behalf of the interests of a tobacco company. There is no doubt that smoking cigarettes leads to severe health risks, and has never been shown to provide any important health benefits. It has been shown by others that tobacco companies seek to have academic institutions do research on their behalf to give their selling of hazardous products a cloak of respectability. For a university that includes a proud and venerable medical school (formerly the Medical College of Virginia, and, for the purposes of full disclosure, a medical school on whose faculty I served for seven years), to help a tobacco company gain such a cloak violates the fundamental health care mission of the school, in my humble opinion.

Thus, it is obvious why this story provoked some outrage among academics:

'When universities sign contracts with these covenants, they are basically giving up their ethos, compromising their values as a university,' said Sheldon Krimsky, a professor at Tufts University who is an expert on corporate influence on medical research. 'There should be no debate about having a sponsor with control over the publishing of results.'

Stanton A. Glantz, a professor at the University of California, San Francisco, School of Medicine who has lobbied for banning tobacco money on campuses, said, 'University administrators who are desperate for money will basically do anything they have to for money.'

At Virginia Commonwealth, few professors appeared to know about the contract; when told about it, a number of them said they were concerned about its secretiveness.

'It’s a controversial area, and I personally prefer transparency,' said Richard P. Wenzel, chairman of the department of internal medicine at the university’s medical school, who had not heard of the contract before a reporter’s call.

A tenured scientist at Virginia Commonwealth, who would not be interviewed for attribution because he said he feared retribution against his junior colleagues, called the contract’s restrictions, especially the limitations on publication, 'completely unacceptable in the research world.'

As we have noted before, often the leaders of academic medical institutions seem to make the pursuit of money, prettied up as "external funding," their highest priority. Thus do the high ideals of academia go up in smoke.

ADDENDUM (26 May, 2008) - See also comments on the Clinical Psychology and Psychiatry blog.

Biovail Pleads Guilty

As reported by by Fortune (via CNNMoney.com):

The big Canadian drug company [Biovail Pharmaceuticals] agreed Friday to plead guilty to U.S. kickback and conspiracy charges. The decision, which closes out a federal investigation of the company's unusual actions in support of a 2003 drug launch, means Biovail (BVF) and a New Jersey-based subsidiary will pay a $24.6 million fine to avoid a court case that could have cost them future business with federal agencies.

The marketing program in question - Proving Cardizem LA through Clinical Experience, or PLACE - aimed to build physician awareness of Biovail's 2003 launch of a crucial product, the long-acting formulation of heart drug Cardizem. Skeptical hedge funds and research outfits charged that by paying doctors up to $1,000 for prescribing the drug for up to 15 patients, Biovail's program amounted to little more than bribery.

Note that, as reported by Bloomberg, the payments were meant to be for "research,"

Biovail's plan [was] to offer them $1,000 to write 15 prescriptions for Cardizem LA, then complete a report on each patient.

However, as Fortune's article noted,

Biovail, the U.S. attorney's office wrote in its press statement Friday, 'did not design or implement the PLACE program in a way calculated to provide new or meaningful scientific data about whether Cardizem L.A. worked better than other available drugs.' It added in settling charges against the company that the payments to doctors exceeded the 'reasonable fair market value' of the physicians' services.

Add this to our collection of grossly unethical financial interactions between health care organizations (in this case, a pharmaceutical company) and physicians. In this case, payments apparently meant to serve as inducements for physicians to prescribe a drug were prettied-up as research support.

Pharmaceutical, biotechnology, and device companies now spend vast amounts on payments to physicians. These include payments for "consulting," "honoraria" for speaking, "royalties" for use of intellectual property, and funding for "research." Rarely do the companies or physicians involved disclose the amounts paid, or what the physicians did in return for these payments. One can only wonder how many other such payments are really for physicians' prescribing particular products, or helping to market these products. Only full disclosure of all payments made to physicians, other than fees for clinical services, could put such concerns to rest.

I would implore my fellow physicians who take payments for "consulting," "honoraria," "royalties," and "research" support to fully disclose these patients, their amounts, and what the physicians have done for them. If such disclosures might seem embarrassing, then the affected physicians should consider whether they should be taking such payments at all. Similarly, the organizations making such payments ought to fully disclose the people getting them, the amounts, and the reasons for the payments. Again, if such disclosures seem embarrassing, then the companies should consider whether they should be making such payments at all.

Physicians rightly often complain the they are being deprofessionalized. Being professional involves subscribing to and upholding a clear code of ethics. A major element of physicians' ethical codes is putting the interests of individual patients first. Taking payments to prescribe particular products, rather than prescribing for individual patients those drugs which are most likely to help, and least likely to hurt those patients, appears to violate this prime ethical directive. Physicians deprofessionalize themselves when they take payments or gifts in return for prescribing specific products. If we do not want to be deprofessionalized, we must not take actions that deprofessionalize ourselves.

UMDNJ Monitor Alleged "No Research Compliance Capability"

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, 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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Most recently, we found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here), and that the monitor found even more bizarre financial practices at the university (see post here).

All things must pass, so UMDNJ no longer has a federal monitor. Apparently, the publicly released version of the monitor's final report noted a number of positive changes at the university. However, a Newark Star-Ledger story revealed that even this report described contained yet another heretofore unknown problem.

Hundreds of millions in federal grants could be at risk because of lax research oversight at the state's medical university, according to a previously undisclosed portion of the federal monitor's report.

The new material, whose conclusions University of Medicine and Dentistry of New Jersey officials vigorously disputed, found the school had 'no research compliance capability' -- jeopardizing future funding, as well as the health of patients in clinical studies.

At issue is the university's problem-plagued Office of Ethics and Compliance, and UMDNJ's ability to audit research spending and report violations of clinical studies' guidelines to the federal government. The confidential portion of the report found the ethics office, whose director recently resigned and is missing other key personnel, had failed in performing critical oversight of federal research grants.

'UMDNJ admittedly has no research compliance capability at all and none is anticipated,' the monitor stated in the report.

University officials vehemently challenged the assertions.

'We have a significant amount of research compliance. We have over 20 years of history of research compliance at this university,' said Denise V. Rodgers, executive vice president of academic and clinical affairs. 'Do you think people ... would risk their reputation coming to an institution if there was no research compliance? Not a chance.'

U.S. Attorney Christopher Christie, who was briefed on the compliance findings, called it a 'serious matter' that seemed to have started long before UMDNJ came under the scrutiny of his office in 2005.

'It's always a problem when you don't have sufficient internal controls on any program. It is even a greater problem for an institution like this,' he said, citing UMDNJ's well-documented troubles with patronage, no-bid contracts and violations of Medicare and Medicaid laws.

In the public version of his final report, the monitor found UMDNJ had significantly improved since the string of scandals that nearly shut down the $1.6 billion university. However, he singled out UMDNJ's ethics and compliance office for criticism. The university's chief ethics officer, Michael R. Clarke, resigned last month after less than 18 months on the job, saying he wanted to return to the private sector. The university is now searching for a successor.

Stern's rebuke of the compliance office was far more harsh in the full report not released to the public. It alerted UMDNJ to failures that investigators only recently began looking into before the deferred prosecution agreement that led to the monitorship termination in December.

All of the monitor's reports released to the public have been edited to omit details of any ongoing investigations, and the final report cited 42 open investigative files based on 'allegations of legal and ethical breaches or conflicts of interest.'

Rodgers attributed the monitor's findings to a 'misunderstanding' over the fact that the university has not yet hired a research compliance officer. She said research at UMDNJ comes under multiple layers of oversight, including an Institutional Review Board; a Human Subjects Protection office; an office of research, as well as an institutional compliance officer and other academic officials.

'This university has over ($115 million) in grants from NIH,' she said. 'You can believe that if they had big concerns that we had no research compliance we would have not been able to get that money?'

I would note parenthetically that the rebuttals by UMDNJ officials seem to be based on logical fallacies, and therefore do not seem very convincing.

The officials first seemed to deliberately interpret the monitor's report in a very concrete way, that it alleged the university literally had not compliance efforts whatsoever. Then, they tried to rebut this straw-man argument by saying that yes, UMDNJ actually has an IRB, a human subjects protection office, etc. In fact, the report did not deny the existence of a compliance structure, it just somewhat sarcastically denied the structure was functional.

The officials then asserted that if the University had no functional non-compliance mechanism, someone ought to have already figured this out, and punished the university for it. This appears to be a version of a logical fallacy called an appeal to consequences of a belief (if X were true, there would be bad consequences. There have not been bad consequences, so X must not be true.) Why the particular problem mentioned in the report, a non-functional research compliance system, should have been more obvious than all the other problems at UMDNJ is not clear.

It's amazing how often the issues discussed on Health Care Renewal inspire health care organizational leaders to creatively use logical fallacies to defend their organizations and prior actions.

Unfortunately, this latest report reinforces the notion that the UMDNJ administration was a poster-child for poor management of an academic health care institution at multiple levels and in multiple spheres. Let's hope that things really are getting better there.

Former Leader of Now Bankrupt Institute for Cancer Prevention Pleads Guilty

A brief AP story published in Newsday alerted me to a significant story of malfeasance that destroyed a once prestigious medical research institution, but till now has remained surprisingly anechoic. Let me piece it together chronologically.

The Institute for Cancer Prevention (IFCP), formerly the American Health Foundation, was hailed (in a press release by New York Senator Charles Schumer) as "the only National Cancer Institute designated cancer center exclusively devoted to cancer prevention research." The Institute was described in a New York Post article (not on the web, Edelman S. Cancer scandal: bankrupt institute blew $5M. NY Post, Oct 3, 2004.):

Known for its early research linking smoking and cancer, the IFCP was the only government-supported center that focused solely on prevention.

It was respected for groundbreaking work on how diet can prevent cancer, touting the benefits of soy, garlic, zinc, tea and low-fat foods.

The institute boasted Rudy Giuliani as guest speaker at its last fund-raising gala, and Bill Clinton came to accept an award given to his wife, Sen. Hillary Rodham Clinton. Whoopi Goldberg hosted an event in 1998.

In February, Sen. Chuck Schumer called IFCP 'one of the world's very best research facilities.'

But in 2004, the Institute abruptly and unexpectedly declared bankruptcy, again per the NY Post,

Financial problems cropped up in 2000 when the institute had to repay the government's National Cancer Institute $4 million in overspent grants.

But the problems continued, culminating in a terse letter to [ICFP President Dr Daniel] Nixon from the institute on Sept. 9.

The letter, written by NCI grant manager Leo Buscher, said the IFCP 'improperly withdrew $5.7 million and inappropriately used those funds for non-grant-related expenses.'

He told The Post the funds should have been used only for researcher salaries, animals and lab supplies, but were diverted to cover the institute's overhead expenses.

'It was a surprise it had gotten so bad and so big,' Buscher said of the overspending.

Increasingly generous executive pay and high rent were biting into the institute's $18 million budget.

Nixon raked in $403,000 in salary and benefits in 2002, according to the latest tax returns filed.

A half-dozen other managers and consultants got $150,000 to $286,000 a year, the records show.

Last year, the institute left a cramped office on the East Side near 42nd Street and leased 15,000 square feet at the Gorham Building on Fifth Avenue and 36th Street.

A subsequent NY Post story suggested that the Institute's President lived the good life at Institute expense while the money was being diverted (not on the web, Edelman S. Wine-&-Dine cancer doc; his institute hits bottom $. NY Post, Oct 10, 2004.)

Dr. Daniel Nixon, a noted cancer doctor whose patients included Jimmy Carter's mom and Atlanta Braves players, was living high as New York's prestigious Institute for Cancer Prevention collapsed around him, The Post has learned.

Nixon, 61, the IFCP president who was paid more than $400,000 a year, enjoyed a full-time chauffeur and leased a car at the institute's expense.

A nutritionist who touted raspberries and strawberries to prevent certain cancers, Nixon jetted around the country to wine and dine 'potential donors,' said sources familiar with his expense vouchers.

Note that the bankruptcy of the Institute was covered in a news item in Science. As far as I can tell, it was never covered in the national media, particularly in the NY Times or the Washington Post, or in any medical or health care journals.

In early 2007, the US Attorney for the Southern District of New York announced a settlement:

Michael J. Garcia, the United States Attorney for the Southern District of New York, announced today that Dr. Daniel Nixon, former president of the Institute for Cancer Prevention ('IFCP'), IFCP’s former officers, and the former members of IFCP’s Board of Trustees have agreed to pay $2,300,000 to resolve civil False Claims Act charges and any other civil claim arising from IFCP’s alleged unlawful receipt and use of federal grant money. In addition, Tatum, LLC ('Tatum'), a financial services firm, has agreed to pay $400,000 to resolve civil claims arising from its services to IFCP. Finally, Weiser, LLP ('Weiser'), IFCP’s outside auditor, has agreed to pay $500,000 to resolve negligence claims relating to its audits of IFCP.

The settlement acknowledged:

During calendar years 2002 and 2003, however, IFCP drew down approximately $5 million of federal grant money to pay bills that were not eligible for reimbursement under its federal grants. In addition, IFCP submitted false financial reports regarding its draw downs to the United States Department of Health and Human Services ('HHS').

But of course,

The settlement does not release any of the parties for any violation of the criminal laws. None of the parties making payments under the settlement agreement has admitted any liability or wrongdoing in connection with the settlement.

As far as I can tell, the settlement received no local, much less national news coverage.

What brought all this to my attention was yesterday's AP story (in Newsday).

A bankrupt cancer research center's former finance chief has admitted lying to FBI agents investigating whether the institution misused federal money.

'I am truly sorry, and I accept responsibility,' Roy Victor said as he pleaded guilty in U.S. District Court Wednesday to obstruction of justice. He faces a possibility of up to 10 years in prison at his sentencing, set for April 18.

Victor, 44, was the Institute for Cancer Prevention's chief financial officer from November 2001 to May 2003. Federal authorities started questioning him in November 2004, two months after the Valhalla-based institute filed for bankruptcy. Federal auditors had found that the research center had improperly sought to use grant money for expenses not related to the grant's purpose, according to court papers.

Victor acknowledged lying when he told federal investigators the institute had not submitted false statements to hide improper requests to draw on $6 million in Health and Human Services Department grants.

This sad tale illustrates what I suspect is an all too common phenomenon. In a go-go, get rich quick, narcissistic culture, in an economy in which health care has become a $2 trillion a year "industry," and in a business climate that worships the "imperial CEO," many respected health care organizations and institutions have been taken over by the wrong sort of people. Their leaders often at best have no understanding or sympathy for the health care mission and health care ethics. At worst, some of their leaders are criminal (see, for example, Mr Victor above) and corrupt. Leaders interested first in short-term financial gain and lining their own pockets are weakening, and in this case of the Institute for Cancer Prevention, have destroyed, some of our best and most revered health care institutions.

Until we make the governance of health care organizations more transparent, accountable, ethical, and respectful of the organizations' missions, things will continue to go down hill. And until physicians, policy makers and the public become aware of the damage being done by ignorant, conflicted and corrupt leadership of health care organizations, nothing will be done at all.

ADDENDUM (5 January, 2008) - Also see more background, links, and comments in this post on the Junkfood Science blog.

BLOGSCAN - What Do Research Subjects Really Think About Investigators' Conflicts of Interest

On the PharmaLot blog, Ed Silverman posted about a new study that purported to show that research subjects don't care about conflicts of interest affecting study investigators. But Silverman also noted that the apparent conflicts of interest of one of the authors, a lawyer for a firm that represents many pharmaceutical companies, were not disclosed, at least in the press release about the article.

Furthermore, Silverman's post suggested that the college students who were the study subjects were only asked about studies in which "the investigator was an employee of the company, ... an employee and consultant, or ... an employee and a patent holder." They were not asked about investigators who had conflicts at all. Thus, at best, the article suggested that college students thinking about being subjects of clinical studies were indifferent about whether study investigators employed by a company thad made the product being tested on the subjects were also company consultants or stock-holders. Maybe the students reasonably assumed that an investigator employed by the company was already so conflicted that adding consulting fees or royalties would merely ice the cake. That's hardly the same as the author's assertion that "this study suggests that disclosure of conflicts may not play a large role in decision-making." One wonders if the study author's willingness to make assertions not supported by his own data had to do with his own conflicts of interest?

BLOGSCAN - "AIDS Pundits and Ties to Big Pharma"

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody wrote about his discovery of a web-site entitled, "AIDS Pundits and Ties to Big Pharma," or by its more economic URL, www.shillfactor.net. The site catalogs, with a degree of sarcasm, the multitudinous financial ties to pharmaceutical manufacturers and biotechnology companies of some of the big wigs in the AIDS/ HIV research and academic world. Some of the individuals have truly amazing numbers of consulting jobs, leading the site writers to speculate how they ever have time to see patients or fulfill their academic responsibilities. The site contains pages for people who "control research," "vote on new drugs," "set treatment specs," "educate the field," "write and report," and ironically, "once were activists." The site is sponsored by Project THAMES, which stands for "transparency in HIV authorship, medical education and scientific investigation." Amazing.

"Mandatory" "Treatment" of University of Delaware Students

This case is already all over the web [starting here], but it has an unusual health care slant which has heretofore not been covered, so....

The University of Delaware, a large, state-supported US university, which includes a College of Health Sciences, recently instituted a new "treatment"program for university students, described in the draft of a detailed report. [Following page references are from that report.] (References to the program, also described as a curriculum, as a "treatment" are on page 8, 10, and 14) Subjects will be exposed to educational and behavioral interventions, the latter described in one document as that which will "leave a mental footprint on their consciousness." An example of one behavioral intervention requires subjects to line up, then step forward or backward in response to questions about their social identities [see p. 2 of this letter.]. The program will be subject to "action research" [p. 3], which "is generally distinguished by being practioner based, focused on actual existing practices, and using data to improve existing practices," [p. 4] and possibly also "summative, research style studies" [p. 3] Outcomes to be assessed include "behavioral changes in reaction to ... educational strategies." [p. 5] Data collection methods include "surveys, formal inteviews, focus group[s]" [p. 11] Subjects with the worst outcomes in particular groups would be individually identified, and subject to additional interventions [see p. 3 of this letter.] The investigators claimed the research "would qualify for an exemption from full [institutional review] board review." [p. 12]

So far, this sounds unremarkable, but, just has been extensively reported by the Foundation for Individual Rights in Education (FIRE), the subjects of this "treatment" program are all students living in all University of Delaware dormitories, not patients with any defined conditions or diseases. Furthermore, as the FIRE case file makes very clear, participation is mandatory. Not only is consent not required for participation, students must participate in the "treatment" and in the associated "action research" study whether or not they want to.

As FIRE noted in a letter to university president, there are a set of objections to all this based on the content of the intervention, which seems to designed to inculcate political beliefs, rather than to educate, and which requires students to affirm beliefs they may not actually hold. For a government institution to expose students to what seems to be mandatory political indoctrination, and to require students to express beliefs which are not theirs raise major constitutional issues.

Setting those aside, this program seems to profoundly violate some fundamental values of health care and of human research. Except in very particular cases of incompetent patients or patients who are at immediate risk of harming themselves and others, no one should be subject to a treatment without his or her consent. In such a situation, compelling subjects to participate in associated research is equally unethical.

Some may argue that the university's description of this project as "treatment" was metaphor or rhetorical excess. However, the repeated use of that term, plus description of the project in behavioral terms, and the clear human research component invite viewing the project as a treatment intervention and associated human research plan.

For an American state university to have gone so far in a plan for mandatory behavioral "treatment" of students without their consent is chilling. It is a reminder that something has clearly gone very wrong in health care and academia, and that the problems are clearly not at all limited to the for-profit corporate sector.

ADDENDUM (3 November, 2007) - the University of Delaware has cancelled its mandatory "treatment" program, as covered by FIRE.

The Plight of the Whistleblower in the UK Illustrated: The Case of the Missing Brain Tissue

We recently discussed the plight of health care whistle-blowers in the US.

From the Guardian (UK), yet another story of the fate that awaits health care whistleblowers in the UK,

Allegations that patients at a Liverpool hospital had parts of their brains removed for medical research during neurosurgery without consenting to the procedure, can be revealed today.

The University of Liverpool is accused of covering up the procedures, alleged to have resulted in at least 12 patients having brain parts removed. Its medical school, which was embroiled in the Alder Hey organ retention scandal, is facing claims that it tried to silence a senior hospital whistleblower who raised the alarm about alleged misconduct by a leading brain surgeon.

Until 2005, the university employed Professor Peter Warnke, who was chair of neurosurgery and operated at the Walton Centre hospital. In 2002, allegations surfaced that Warnke had been taking tissue from the brains of living and dead patients at the Walton Centre without obtaining consent.

Warnke is alleged to have taken samples of brain tissue during surgery, freezing them in liquid nitrogen, marking them with a black dot and sending them to Genpat 77, a private biotechnology company in Germany. The samples were used to test a new treatment for brain diseases involving an antibody called TIRC 7. Warnke was a joint owner of the patent taken out on TIRC 7, along with the founder of Genpat 77. Warnke has always vigorously contested claims of wrongdoing. The Observer has established that, at around the same period, Warnke attempted to obtain tonsils that had been removed from patients at the Aintree Hospital in Liverpool for use in associated research. Elizabeth Preston, the hospital's medical director, said: 'I can confirm that Professor Warnke did ask for tonsils, but a nurse questioned whether he had ethical consent. He was refused and as far as I am aware he never had access to any tissues from Aintree.'

Both the nurse and a surgical colleague of Warnke's raised questions about his conduct with Dr Marco Rossi, who then chaired the regional ethics committee set up to improve research standards after the Alder Hey scandal, where hundreds of children's organs were retained without parents' consent. Rossi, who was a consultant neuropathologist at the Walton Centre, claims that when he began investigating the allegations against Warnke he suffered threats from senior staff at the university's medical school. He claims that the level of intimidation made him ill and he was unable to continue his work.

Rossi is suing the Walton Centre, the University of Liverpool and the strategic regional health authority for breach of contract. He argues that as a senior employee and whistleblower they should have protected him, and claims that senior medical school staff were more concerned in covering up a potential scandal. He alleges that he was subjected to a campaign of bullying and harassment in an attempt to get him to withdraw his accusations. In court, the university has argued that Rossi's allegations about Warnke were irrelevant and should not be heard.

Last week, a judge rejected this and ordered the university to hand over its dossier on the affair, including an internal investigation into Warnke's conduct. The court has heard that Rossi alleges that dozens of ethical consent forms used by Warnke for his research were either incomplete or inaccurate.

Although Rossi left in 2002, no action was taken against Warnke until April 2005, hours after Rossi launched his legal action. Warnke was suspended and later resigned. In November 2006 he was appointed chief of neurosurgery at the Beth Israel hospital in Boston, part of Harvard Medical School.

The British law firm Weightmans, which is acting for Warnke, issued a statement to The Observer rejecting Rossi's claims. It said the allegations against Warnke were 'brought by a disgruntled former employee and a colleague of our client'.

Also see the BBC coverage here.

As in the recent US case which we discussed, note that it was the person who came to the aid of the original whistle-blowers who allegedly found himself in even hotter water than they did.

It seems that many types of health care organizations in many countries lack a mechanism to give whistle-blowers a fair hearing, investigate their complaints, and protect them from the wrath of those they accuse, and from institutional leadership which fears those who would rock the boat, even if it is in an effort to alter course away from the iceberg.

"Web of Conflicts"

California's new initiative to fund stem cell research has already been mired in politics. The announcement of the new chairman of the committee overseeing the institute has just increased the level of controversy, according to the New York Times. The new chair, Robert Klein, is a wealthy real-estate developer with a law degree, but with no apparent health care expertise. He does have strong ties to the Democratic party, and contributed to the campaigns of three of the politicians, including Republican Governor Arnold Schwarznegger, who supported him for the chairmanship position. Other members of the oversight committee have been criticized for their financial ties to biotechnology and pharmaceutical firms, in a "web of conflicts," per the Foundation for Taxpayer and Consumer Rights. The vice chairman was the founder of Chiron Corp, (which owned the British factory whose production of flu vaccine was shut down this year, leading to the flu vaccine shortage). We shall see how well this committee oversees the spending of $300 million a year on stem cell research.