More Questions about Industry Influence on the Reagan Udall Foundation

According to the FDA News, an appropriations bill just passed denied funding to the new Reagan Udall Foundation. According to an FDA press release, "the private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety."

Questions have been previously raised about the influence industry would have on this foundation. The FDA News previously reported

Rep. Rosa DeLauro (D-Conn.), chairwoman of the subcommittee that funds the FDA, has warned that there is no framework to minimize the industry’s influence on the foundation.

Earlier this year, DeLauro sent a letter to FDA Commissioner Andrew von Eschenbach expressing concerns with pharmaceutical industry funding of the foundation, saying it could endorse the approval of drugs based on lower standards. The FDA should postpone activities related to the foundation until it can assure the pharmaceutical and device industries will not have undue influence, DeLauro said.

Not only would the foundation get money from industry, the leadership of the foundation would have direct and indirect industry ties. The legislation setting up the foundation authorized some seats on the board of directors for people representing industry. Thus the new board includes the President and CEO of GE Healthcare, a Senior Health Policy Advisory [sic] from Genzyme Corporation, and the Group President of Johnson and Johnson Pharmaceutical Research and Development (per the press release).

Other board members appear to have conflicts of interest, however. We previously posted to note that Dr Tadataka Yamada was formerly an executive of GlaxoSmithKline, and was alleged by a report by the US Senate Finance Committee to have been involved in the intimidation of an early critic of rosiglitazone (Avandia) (see post here). Also, Dr William Brody just retired as a board member of Medtronic Inc, and as of the July, 2007 proxy statement, held over 76,000 Medtronic stock shares or options.

Some quick work with Google reveals that two other board members also have industry ties. Phillip A Sharpe, according to his CV, is:

• Member of the Scientific Advisory Board of Sirtris Pharmaceuticals
• Member of the Scientific Advisory Board of Fidelity Biosciences Group
• Member of the Board of Advisors, Polaris Venture Partners
• Co-founder of Alnylam Pharmaceuticals (2002), Chairman of the Scientific Board and member of the Board of Directors
• Co-founder of Magen BioSciences Inc. (2006), member of the Scientific Board and member of the Board of Directors

He also was "Co-founder of Biogen, Inc., 1978 (now Biogen Idec), Chairman of the Scientific Board (to 2002) and member of the Board of Directors."

Also, the not-for-profit chaired by Ellen V Sigal, Friends of Cancer Research, gets extensive funding from the pharmaceutical industry. Its largest donors include Amgen, AstraZeneca, Bayer HealthCare, Bristol-Myers Squibb Oncology, Genentech Inc, GlaxoSmithKline, Johnson and Johnson, Novartis Oncology, Pfizer Inc, and the Pharmaceutical Research and Manufacturers of America, according to its most recent report.

That adds up to a majority (seven of 13) of the Reagan Udall Foundation board with ties to the pharmaceutical, biotechnology, and medical device industries. There is reason for concern that this foundation, despite its relationship to the FDA, is likely to put the interests of these industries ahead of those of the general public.

Yet, the FDA News quoted Peter Pitts, described as "Center for Medicine in the Public Interest President," on Rep DeLauro's concerns, "These sorts of fear tactics are extraordinarily contrary to public health. It just shows how low a point we have reached when a member of Congress can accuse the FDA and the pharmaceutical industry of actually striving to lower standards. It’s just absurd." Pitts, of course, neglected to mention that (as we have discussed most recently here) he holds down the day-job of Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view, which the quote above seemed to do.

The pharmaceutical, biotechnology, and medical device industries already have extraordinary resources to market their wares and shape public opinion. They do not need a government sponsored foundation to help them innovate or develop products. The public does deserve a government agency that protect its health and safety by making sure that drugs and devices are safe and effective, and that operates free of the influence of those with vested interests, especially in the drugs and devices the agency is supposed to evaluate.

ADDENDUM (4 January, 2008) - See follow-up on this by Ed Silverman on the PharmaLot blog.

Why Was This Quality Improvement Research Project Shut Down?

An op-ed in the New York Times by Dr Atul Gawande drew attention to an inexplicable government decision to shut down an apparently worthwhile research project.

IN Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

There seemed to be no question that the the quality improvement (QI) project involved an intervention on physicians, not patients. The project involved use of a simple checklist by intensive care unit (ICU) physicians designed to reduce hospital-acquired infections. The items on the check-list, described in a New England Journal of Medicine article [Pronovost P, Needham D, Berenholtz S et al. An intervention to decrease catheter-related bloodstream infections in the ICU. New Engl J Med 2006; 355:2725-2732. See link here.] consisted of "hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters."

The prospective cohort study apparently collected data from the charts of patients hospitalized after use of the check-list was begun to determine their clinical outcomes.

The main objection by the OHRP seemed to be that the project did not get permission from patients to use information from their clinical records. Research involving collecting data from patients' clinical records usually is considered to be extremely low risk to patients if the information collected is not sensitive, and the researchers protect the confidentiality of the data.

The decision to shut down this observational research project appeared to be extreme and based on, to be charitable, exceedingly narrow and nit-picking ground. The data collected did not appear to be sensitive; there was no question about protection of its confidentiality; the QI intervention could have been carried out without associated research and without patient informed consent (since the intervention affected physicians directly, not patients); and the study was apparently approved by local institutional review boards (IRBs). (See two letters by Kristina C. Borror, Ph.D., Director of the Division of Compliance Oversight at OHRP, to Johns Hopkins University officials, here and here.)

Gawande called the government's decision "bizarre and dangerous." On the Health Beat blog, Maggie Maher speculated, "someone was worried that the checklist program would draw too much attention to just how prone to error our healthcare system is." On the Health Care Organizational Ethics blog, Dr Jame Sabin cited the Hastings Center report on the ethics of QI research, and wrote, "it is hard to avoid suspicion about the motives of the OHRP for scuttling the project. But whatever the motivation behind OHRP’s actions, it is important for the agency to reverse course promptly."

While doctors are endlessly criticized for medical errors and poor quality care, there has been little financial support for quality improvement research available from government, foundations, or commercial sources. Thus it is galling to see an apparently worthwhile and very low risk quality improvement study shut down, especially when much more risky interventional studies are allowed to continue.

For example, while this study was shut down, the US Food and Drug Administration (FDA) let a poorly designed controlled trial of gene therapy administered into individually inflamed joints of patients with inflammatory arthritis, a trial which already saw the unexpected and unexplained death of one subject from overwhelming infection, restart (see post here). Maybe it is time for conspiracy theories...

ADDENDUM (2 January, 2008) - also see comments on the Effect Measure blog, and by MedInformaticsMD on Health Care Renewal.

New DSM Task Force Members' Ties to Pharmaceutical Companies

The latest reminder of the pervasiveness of financial entanglements among physicians and medical researchers and health care corporations comes from a story in US News and World Report. The topic was how the American Psychiatric Association is attempting to make the development of the new edition of The Diagnostic and Statistical Manual of Mental Disorders the "most transparent" ever. The impetus behind the new transparency may have been criticism that the last edition was written by a group of authors heavily financially entangled with health care corporations (see post here, based on early reports of the results of this article: Cosgrove L, Krimsky S, Vijayaraghavan M et al. Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychother Psychosom 2006; 75: 154-160, available here).

This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests.

Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare [see them here]; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: 'Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved.'

Critics say the limited information violates the spirit of disclosure. 'There is disclosure, and then there is disclosure,' says Daniel Carlat, a psychiatrist and former consultant to drug companies [and blogger on the Carlat Psychiatry Blog]. "There is a big difference between $500,000 and $500. It is one thing to disclose in a generic way, to say that a psychiatrist has had some consulting with a company, but that doesn't tell you a number of things.'

Furthermore, the disclosure appears incomplete in many ways. There were errors by the task force members.

Dilip Jeste, a professor of psychiatry at the University of California-San Diego, had consulting ties that did not appear on his disclosure form. Yet during the reporting year of 2003, he was a consultant to Pfizer and AstraZeneca and received honoraria from Pfizer, according to documents. Jeste called the error 'unintentional,' saying he had relied on memory. The APA said that Jeste would submit a new disclosure. APA President Carolyn Robinowitz said that task force nominees 'were on the honor system' and acknowledged that the association had made no effort to check their accuracy.

There were errors by the APA.

The APA itself erred in its public summary for Jan Fawcett, a professor of psychiatry at the University of New Mexico and chair of the DSM's mood disorders work group. The summary lists no directorships or corporate positions for Fawcett. But a 2005 sec filing shows that he was a member of the board of directors for Berman Health and Media, a company that is poised to 'exploit opportunities in the female sexual medicine industry.' [He has since resigned from the board.] The APA said that Fawcett had disclosed the connections in private filings but that its staffers accidentally omitted them from the public disclosure form.

It's funny that the errors always seem to be of omission, not commission.

Also, task force members who received funding from medical education and communication companies (MECCs), that were, in turn, funded by drug companies, did not disclose the latter funding.

David Kupfer, the task force chair, reported multiple consulting arrangements with communications companies that 'sponsored pharmaceutical meetings & editorial work.' His public form, however, does not reveal that income from two of these companies, Prescott Communications and Innovative Medical Education, came from work for Forrest Pharmaceuticals and Pfizer, respectively. The APA said Kupfer did not need to disclose the ties because he was not paid directly by drug companies.

The APA actually not only required disclosing conflicts of interests, it required that "members pledged to limit their aggregate income from pharmaceutical sources to $10,000 a year. If their income exceeded that amount, they were required to reduce it or sever ties." On the other hand, "critics say that loopholes weaken the policy. One is that task force members can undertake new financial arrangements after being appointed. Second, task force members are not asked to disclose 'unrestricted research grants,' which often go straight to one's department or institution."

Given that the reporting may have been incomplete, it is striking that 18 of 27 (two thirds of the) members of the Task Force reported financial ties to the pharmaceutical industry, and that many of these reported multiple kinds of ties, and/or ties to multiple companies. Given how influential the DSM is on the mental health practice, and given how expansions of definitions of mental illness provide new opportunities to develop costly treatments for them, it is disturbing that the group who will develop the new DSM has had such extensive past relationships with the pharmaceutical industry.

ADDENDUM (2 January, 2008) - See also coverage of this case in Integrity in Science Watch (2 January, 2008 issue when up), and PharmaLot.

University of Massachusetts Tightens Conflict of Interest Policy

As reported by Liz Kowalczyk in the Boston Globe, the University of Massachusetts Medical Center has just adopted "some of the strictest conflict of interest rules in the country." In particular,

It prohibits doctors and other clinical staff from eating meals paid for by companies; bans all gifts, from candy to medical journals; stops drug companies from giving money directly to individual physicians and departments for educational programs; and places a complete ban on doctors joining company 'speakers bureaus' to give talks about products.

This policy seems more stringent than others recently adopted at other medical schools in the US.

The UMass Memorial policy goes further than those at most other hospitals in several ways. It bans company-paid meals off and on campus. It also establishes strict rules for doctors who serve on committees that decide which drugs and devices the hospital should buy in bulk to treat patients. Most hospitals require doctors simply to disclose their financial relationships with companies to other committee members.

But UMass Memorial decided that doctors with consulting agreements or grants from companies cannot serve on these committees, meaning some current members may have to resign. The danger, conflict of interest specialists say, is that doctors may select a drug for the hospital's 'formulary' because he or she does work for the manufacturer, not because it is the best, lowest-cost medication.

In addition, I don't believe many other medical schools ban faculty from receiving honoraria from pharmaceutical companies for giving talks.

Nonetheless, the policy does not address some conflicts of interest that are potentially important because of the amounts of money involved. It does not restrict faculty who serve as consultants to industry. Not even discussed in the Boston Globe article were physicians who get royalties from device companies. We recently posted about some examples of academic orthopedic surgeons getting astronomical payments of this sort (see this post and links backward). Also not discussed were physicians who serve on the boards of directors of for-profit health care companies. Directors may receive relatively large payments and stock options grants. Serving on a board presents potential conflicts beyond just those involving receipt of money. Board members have a fiduciary duty to protect the interests of company stock-holders, in fact, to have "unyielding loyalty" to them. (See recent post here.)

Nonetheless, the Boston Globe article quoted experts who were worried about restrictions on conflicts of interest going to far.

'You don't want to chase drug company money out of the system completely,' said David Rothman, a history of medicine professor at Columbia University and director of the university's Center on Medicine as a Profession. 'Drug companies are not tobacco companies. We all need them.'

But, Rothman said, hospitals need to 'sever the tie between the company and the prescribing physician.'

Rothman was a coauthor two years ago of an article in the Journal of the American Medical Association that called for teaching hospitals to sharply limit the gifts and money they accept from pharmaceutical and medical device makers, and laid out a blueprint for a policy.

Obviously, drug (and device and biotechnology companies) make very important products without which modern medicine would grind to a halt. Yet nothing in the University of Massachusetts policy threatens these companies' existence. Nor would a ban on faculty being paid consultants of, receiving royalties from or being on the the board of directors of health care corporations. It's funny how restrictions on financial relationships between medical school faculty and health care corporations seem to bring out slippery slope arguments. Faculty could talk to and work with health care corporations to advance science without directly being paid for such work. And nothing in the proposed, or even more stringent policies would prevent companies from hiring people with expertise they needed, just as long as such people did not pretend to also be full-time faculty at medical schools.

On the other hand,

Partners HealthCare, which includes Massachusetts General Hospital and Brigham and Women's Hospital and is the largest provider network in the state, 'will be tightening up' its policies, said Dr. David Torchiana, head of the Massachusetts General Physicians Organization. But, he said, he doesn't want to go overboard.

'Academic medical centers are here to advance knowledge, but discoveries have no value to patients unless they get made into products,' he said.

'We don't want to kill that by enforcing an overly strict conflict of interest policy. It's a little bit of a runaway train right now: If you've ever eaten a slice of pizza supplied by a company you are irredeemably tainted,' he said.

Again, it's interesting how different people interpret the notion of an "overly strict conflict of interest policy." There is some common sense in worrying that a policy that focuses on slices of pizza may be too strict. But contrast Dr Torchiana's approach with Dr Rothman's approach to focus on all ties to the practicing physician, while being much more lenient on the faculty member with a $100,000 a year consulting gig.

In my humble opinion, even slices of pizza may convey some small sense of obligation, and lots of pizzas, pens, and mugs spread over thousands of doctors may have some collective effect. But it would make more sense to concentrate first on the much bigger and consequential ties among the most influential doctors and health care corporations, then large consulting payments, often even larger royalty payments, and service on boards of directors. Yet that seems to be the opposite of what is going on.

But give the University of Massachusetts kudos for some small steps in the right direction.

Data About Ezetimibe Adverse Effects Suppressed?

Here we go again. Last week, an article by Alex Berenson in the New York Times reported that Merck and Schering-Plough conducted trials of ezetimibe (Zetia, by Schering-Plough, and a component of Vytorin, by Merck) "that raise questions about its risks to the liver," but never publicly reported their results.

Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.

A Schering executive, when asked by a reporter about the unpublished studies, confirmed their existence. But the executive, Dr. Robert J. Spiegel, said the companies had not considered the studies scientifically important enough to publish their findings. Some may eventually be published, he said.

The unpublished Zetia studies, devised as safety tests, would not prove the drug’s effectiveness. But they would give the public more information about Zetia’s potential risks. All the unpublished studies covered periods at least one year in length and were intended to show whether long-term use of Zetia might pose dangers that short-term use did not.

Most of the studies about Zetia in which Merck and Schering have published the results covered periods of only 12 weeks — not enough time for liver problems to develop in most patients.

The unpublished studies, conducted from 2000 to 2003 according to the F.D.A. documents, were not listed on the industry Web sites where companies are supposed to register the results of all drug trials that were ongoing after October 2002. The New York Times discovered references to the studies in briefing papers on the F.D.A. Web site.

Together those studies cover several thousand patients who took Zetia along with statins for one to two years. The statins include Lipitor and Crestor, as well as Zocor, which is usually prescribed generically as simvastatin and is the statin used in the Vytorin pill. Doctors often add Zetia to a low dosage of a statin, because Zetia reduces cholesterol in a different way than the statins do and leads to deeper overall cholesterol reductions.

'We’re pretty comfortable that people don’t have trouble tolerating Zetia,' said Dr. Spiegel, the chief medical officer of the Schering-Plough Research Institute, Kenilworth, N.J.

I agree more with this response by Dr Harlan Krumholz, from Yale.

We keep telling people we want to practice evidence-based medicine, and what we keep finding out is that much of the evidence is obscured.

There is important evidence, but it’s not in public view. It’s hidden from investigators.

As I have noted now it seems ad infinitum, to make the best decisions about patient care, physicians and patients need access to the best relevant evidence from clinical studies. Concealing evidence about, say, the toxicities of a particular drug may lead to bad decisions, specifically, prescribing the drug when its possible harms outweigh its risks.

In addition, suppressing the results of clinical research betrays the trust of human research subjects who were participating because they thought the research might advance science and/or patient care. Obviously, suppressed research can do neither.

This is one more anecdote suggesting that either clinical research sponsored by the companies who make the products the research is meant to evaluate needs much stronger regulation, or such research should be taken entirely out of the hands of the companies who stand to benefit if its results turn out a certain way.

See also comments in the Clinical Psychology and Psychiatry Blog, the Hooked: Ethics, Medicine and Pharma blog (with clinical and clinical epidemiologic background), the Medical Evidence Blog (suggesting a boycott of ezetimibe), and the Scientific Misconduct Blog (warning, contains adult language.)

BLOGSCAN - Brian Klepper on Paul Levy on Transparency

On the Health Care Blog, this post by Brian Klepper refers to some strong comments on the importance of transparency, originally made by Paul Levy on the Running a Hospital Blog.

You Can't Tell the (Health Care Policy Op-Ed) Players Without a Scorecard

With the run-up to the US presidential election starting in earnest, public discussion of health care policy issues is ramping up. As has occurred before, we hear a lot from people apparently on the right who advocate for a laissez faire approach to health care free of government involvement. Such people often tend to approve of much of what health care corporations do. We also hear a lot from those apparently on the left who favor government operation of particular segments of the health care system, particularly health insurance. They tend to be very critical of corporate health care, but to approve of much of what the government does.

These discussions often take place in the most prominent fora in the main stream media. For example, last week Dr Scott Gottlieb wrote "Stop the War on Drugs," a commentary for the Wall Street Journal. Gottlieb focused on how the US Food and Drug Administration and the Department of Justice challenge off-label marketing by pharmaceutical companies. He noted cases in which he contended that the government prosecuted companies for "educational" dissemination of information already widely available in the medical literature. Further, he implied that these attempts are part of efforts to make "off label" into "dirty words in the conventional lexicon." Gottlieb did not address cases in which companies promoted off-label use which was not supported by good evidence, e.g., the Neurontin case, and seemed to conflate marketing with education. His main point seemed to be that overly strict regulators were hindering physicians' education and hence keeping people from getting the drugs they need.

Also last week, Dr David Himmelstein and Dr Steffie Woolhandler wrote "I Am Not a Health Reform," a commentary for the New York Times. The thrust of this article was to discredit the employer mandate approaches now advocated by some presidential candidates to reform health care. They called the "mandate model" "economic nonsense." Instead, they asserted "only a single-payer system of national health care can save what we estimate is the $350 billion wasted annually on medical bureaucracy and redirect those funds to expanded coverage." Himmelstein and Woolhandler did not address any deficiencies in how our current national single-payer system, Medicare, allocates money, in particular how it follows reccommendations by the secretive, proceduralist-dominated RBRVS Update Committee (RUC) that have lead to a relentless squeeze on primary care. Their main point seemed to be that only government run health insurance will solve our current problems.

Thus, much of the debate seems to be between those who see any government involvement in health care as ill-conceived or worse, and those who see government operation of whole health care segments as the only solution. Rarely discussed are ways in which government could better regulate health care to improve health and safety, without actually running it; or ways to re-invigorate the involvement of not-for-profit organizations in health care so they actually fulfill their missions, or revitalize the health professions so they can rediscover their professional values.

Perhaps this domination of the debate by those on the extreme ends of the spectrum would lessen if the audience knew more about who was trying to sway them.

Dr Scott Gottlieb, for example, was described in the WSJ as "a practicing physician and resident fellow at the American Enterprise Institute, [who] was deputy commissioner of the FDA from 2005 to 2007." However, Dr Gottlieb has more relationships with health care corporations than were revealed by this one-sentence biography.

Just before he took that job, the Seattle Times reported, "Only a month ago, Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors." Also, "he also has consulted for, and written positively about, a major matchmaking firm that links doctors with Wall Street investors, the Gerson Lehrman Group in New York."A few months later, the Boston Globe reported that as FDA Deputy Commissioner, Dr Gottlieb had to recuse himself from discussions about dealing with an avian flu epidemic

because his past consulting work for [large public relations firm] Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic. Gottlieb's former clients include Roche -- manufacturer of the highly sought antiviral Tamiflu -- and Sanofi-Aventis, parent company of the nation's sole flu vaccine manufacturer.

Manning Selvage & Lee paid Gottlieb a $12,500 monthly retainer for nine months for business development projects that included eight companies. Other firms regulated by the FDA he was involved with include Inamed Corp., one of two companies seeking to return silicone gel implants to the market. He also did private consulting work for VaxGen Inc., a California firm that won a $878 million federal contract to supply 75 million doses of anthrax vaccine for the nation's protective stockpile. The $9,000 he accepted from VaxGen for consulting work between May and July prevents him from doing FDA work related to that company until August 2006.

Furthermore, Gottlieb was recently appointed to the board of directors of Molecular Insight Pharmaceuticals, a "a biopharmaceutical company specializing in the emerging field of molecular medicine." As a member of the board, Gottlieb is supposed to have "unyielding loyalty" to the company's stock-holders.

Readers of Gottlieb's opinions about health care, especially those that favor a laissez faire approach to regulating pharmaceutical companies, need to wonder the extent that these beliefs are influenced by his former and current ties to the industry.

On the other hand, Dr Himmelstein and Dr Woolhandler were identified as "professors of medicine at Harvard and co-founders of Physicians for a National Health Program." While Dr Himmelstein and Dr Woolhandler have long used the friendly Canadian example of single-payer government health insurance to buttress their arguments to the public,(1) in the past, and did so again in their latest op-ed, they previously acknowledged that their approach was frankly "Marxist," rather than Canadian.

They authored apparently pure Marxist analyses of health care in the late 1980s.(2-3) Previously, they had openly advocated for "socialized medicine."(4) They praised the operations of the communist health care system under Tito in what was then Yugoslavia.(5)

Readers of Dr Himmelstein's and Dr Woolhandler's opinions about health care, especially those that favor the government running health care insurance, need to wonder about the extent that these beliefs are influenced by their ideological ties to Marxist and communist theories that in retrospect have been discredited.

Those who opine on major health policy issues should at least reveal where they are coming from. In any case, the debate would benefit from some fresh voices not tied either to health care corporations or Marxist ideology.

References

1. Woolhandler S, Himmelstein DU. A national health program: northern light at the end of the tunnel. JAMA 1989; 262: 2136-2137.
2. Himmelstein DU, Woolhandler S. The corporate compromise: a Marxist view of health maintenance organizations and prospective payment. Ann Intern Med 1988; 109: 494-501.
3. Woolhandler S, Himmelstein DU. Ideology in medical science: class in the clinic. Soc Sci Med 1989; 28: 1205-1209.
4. Himmelstein DU, Woolhandler S. Socialized medicine: a solution to the cost crisis in the United States. Int J Health Services 1986; 16: 339-354.
5. Himmelstein DU, Lang S, Woolhandler S. The Yugoslav health system: public ownership and local control. J Public Health Policy (9) 1984; 423-431.

A Managed Care CEO Takes a Closer Look at the RUC

We have posted frequently, most recently here and here, about the RBRVS Update Committee's (RUC) responsibility for Medicare's relatively poor reimbursement of primary care and other "cognitive" physicians' services compared to procedures. Although the AMA claims that the RUC is just an "expert panel," it appears de facto to be the only source of input to Medicare about how to revise physicians' reimbursement. However, rather than operating transparently so as to represent the views of at least the broad physician community, the committee's proceedings are secret, as are the names of its current members, who mainly represent surgical sub-specialties. Concern about the RUC has been more evident in the blogsphere, if not openly anywhere else. Most recently, the issue was noted on the Let's Talk Health Care blog, by none other than the CEO of Harvard Pilgrim managed care organization. Maybe now there is just a little momentum to take a closer look at how Medicare sets physician reimbursement, and maybe to develop a more transparent and accountable method of doing so that represents the interests of all physicians and all patients.

Another Academic Medical Leader (This Time at Vanderbilt) Named Corporate Director (This Time at Merck)

We have previously blogged about the apparently major conflicts of interest generated when a leader of an academic medical institution is also simultaneously on the board of directors of one or more for-profit health care corporations.

The Associated Press (here via the Houston Chronicle) just reported that Dr Harry Jacobson has been appointed to the board of directors of Merck and Co. The AP report also noted that Jacobson is on the board of Kinetic Concepts Inc. A cursory Google search revealed Dr Jacobson is a founder of Radiation Oncology Services of America (via the Nashville Business Journal) and was formerly on the board of the Renal Care Group (via PRNewsire).

Meanwhile, Dr Jacobson's day job is to be Vice-Chancellor of Health Affairs of Vanderbilt University. So here is yet another example of a top leader of an academic health care institution who is also on the board of directors of in this case three for-profit health care corporations, including one of the largest pharmaceutical companies in the world, plus two smaller local companies.

According to the Third Edition of Corporate Governance by RAG Monks and N Minow, a member of the board of directors of a public, for-profit company must "demonstrate unyielding loyalty to the company's stockholders." So it would appear that Dr Jacobson, like other top leaders of academic medical institutions who serve on the boards of for-profit health care corporations, has quite some conflicts of interest. How can he simultaneously demonstrate "unyielding loyalty" to a pharmaceutical company, a company that produces wound care therapeutics products, and a company that provides outpatient radiology services, and meanwhile be devoted to the health care mission of Vanderbilt University? But at the moment, nobody at the University seems concerned about it. And these kinds of conflict of interest have excited little interest, while many bytes and much ink and paper address the conflicts generated when medical students, interns and residents, or practicing physicians receive pens or mugs with corporate logos, or free pizzas (see this post). Go figure, and let the good times roll....

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?

Manipulation of ENHANCE Reversed

We, and many others have written about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how aspects of it seemed meant to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected. After considerable public discussion, and the threat of a US congressional investigation, things have changed, as Ron Winslow reported in the Wall Street Journal,

The lead researcher of a long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.

Under mounting criticism, the companies last week reversed the earlier decision to change the primary measure to evaluate the drug.

John P. Kastelein, a cardiologist at Academic Medical Center, Amsterdam, and principal investigator of the study, said he breathed a 'sigh of relief' when the companies told him last week they were reversing course.

'It's never, ever right to change the primary endpoint of a study,' especially after all the data are in, he says. 'It is statistically not good and it gives the wrong impression to the outside world.' He says he initially went along with the plan but now regrets not firmly resisting it from the outset.

He says the episode was the culmination of a long-running battle over the conduct of the trial and the companies' worries that some deficiencies in the data would jeopardize a good result.

We have posted frequently about cases in which a sponsor manipulated the design, implementation, analysis, or dissemination of clinical research to increase the likelihood that the results would favor the sponsor's product (e.g., recently here and here). One important study showed the contractual basis for such manipulation when studies are done in academic medical environments (see post here). In extreme cases, sponsors have attempted to suppress the research results entirely when they turn out to be unfavorable to their interests (e.g., see recent post here). Such manipulaton, of course, is bad for patients and doctors, since it impedes their ability to make decisions about tests, treatments etc based on the best clinical evidence. It also betrays the trust of people who volunteer to participate in research thinking that the goal is to improve health care and advance science.

So this case is unusual, in that an early public outcry resulted in at least some of the clinical research manipulation being reversed. There may be hope yet.

BLOGSCAN - More About Methodologic Flaws in Targeted Genetics Trial

We have posted a few times about an ill-fated trial of a gene therapy treatment. To summarize the case thus far, a young woman received a dose of an adeno-associated virus carrying a gene that was meant to have a local immune suppression effect, tgAAC94, made by Targeted Genetics, directly into her joint as part of a phase I study meant to assess the safety of the treatment. Soon after the treatment, she became ill, then very ill, and ultimately died in an intensive care unit. Although many flaws in the trial were identified in retrospect, and although there was no proof one way or the other whether the treatment was related to the patient's death, the trial was just allowed to resume (see most recent post here). This post by Dr Chris Evans on the Bioethics Forum identifies yet more methodologic problems with the trial, further challenging the wisdom of resuming it without substantial modifications.

UCSF Medical School Dean Fired After Protesting Financial Irregularities

Multiple news reports over the weekend recounted the firing of the Dean of the University of California - San Francisco (UCSF) medical school, Dr David Kessler, after he claimed he tried to identify and rectify financial irregularities at the school. First, here are the main points from the San Francisco Chronicle:

Dr. David Kessler, the onetime commissioner of the Food and Drug Administration who became dean of the UCSF School of Medicine in 2003, was fired Thursday night after years of discord over finances at the prestigious medical school.

Kessler's boss, campus Chancellor Michael Bishop, announced the dean's departure Friday morning in an internal e-mail to faculty members but did not disclose the reason.

Hours later, Kessler told The Chronicle that he had been labeled a 'whistle-blower' by the University of California after he repeatedly sought to uncover what he called 'financial irregularities that predated my appointment.'

At the heart of the dispute, Kessler said, are tens of millions of dollars in funds that he believes should have been in the dean's office account prior to his starting the job, but have never been properly accounted for because of what he called 'poor financial controls.'

UC officials countered that Kessler was mistaken about how much money should have been in the fund, and a university spokeswoman said Friday that two audits done after he raised the matter found no irregularities.

The spokeswoman said Kessler first raised the issue in the spring of 2005.

If so, that was after an anonymous complaint was sent accusing Kessler of lavish spending. An internal UC audit found no support for the anonymous allegations against Kessler.

Kessler talked to the Chronicle reporter about what happened.

In an exclusive interview with The Chronicle, Kessler claimed the firing was the culmination of a long effort on his part to straighten out the finances of the medical school dean's office - an effort that he said remains unfinished.

'It was a matter of financial integrity,' he said. 'I tried to work within the system for 2 1/2 years, to get it fixed. I wanted to protect the school, the institution.'

He said that Bishop had asked him to resign last summer, but that he had refused. When Bishop asked him to resign again on Thursday, Kessler said, he once again declined and was fired.

At issue, according to Kessler, was his discovery after a year in office that the amount of money available to run discretionary programs in the dean's office was millions of dollars less than he was promised when he took the job. He conducted his own financial analysis in December 2004, concluding the source of the problem was an $18 million annual discrepancy dating from the fiscal year ending in 2002, a year before he arrived.

Kessler told The Chronicle that he had been provided financial documents before he joined showing there would be an annual infusion of $46.4 million for the dean's office to spend on a variety of programs, but he subsequently discovered the figure was $28.8 million.

With each successive year since 2002, the discrepancy has been accumulating, reducing the financial viability of the dean's office.

An interview with the New York Times provided more detail,

Dr. Kessler said that before he accepted the position as dean in 2003, he requested information on the medical school’s financial condition. The documents he received showed that the institution expected generally to take in more, from grants and other sources, than it spent.

But Dr. Kessler said that he requested another such report once he was dean. He found that the two reports showed different numbers for years that had already passed.

'No accounting system should give you different numbers for the same closed fiscal years,' Dr. Kessler said. He said he took his concerns to the university. He said he also commissioned an outside report that found 'the financial practices of the school did not meet operating standards that would be expected at a large organization or business and that there was insufficient oversight.'

As did a report in the Los Angeles Times,

Kessler said UCSF officials from the time of his recruitment misled him about the financial health of the so-called central medical school, which provides funds available for use by the dean. Kessler provided The Times with several internal memos, financial spreadsheets and letters to support his contention.

The central fund's financial health affects the school's ability to remain competitive, recruit prominent faculty and launch innovative research.

According to a financial spreadsheet dated April 5, 2007, supplied by Kessler, the school's finance unit projected that the central medical school would run out of money in the 2008-09 fiscal year. By June 2011, it is projected to have negative net assets of $49 million.

According to financial estimates given to Kessler in June 2003, the school was projected to have revenue of $46 million to $47 million each year. In reality, Kessler said, the school's revenue was far below $40 million every year since he arrived, except in fiscal year 2006 because of a one-time patent settlement.

'If you had $47 million a year, you wouldn't be in a hole,' Kessler said in an interview.

In a letter dated July 5, 2007, [UCSF Chancellor and Nobel Prizer winner J. Michael] Bishop acknowledged to Kessler that the financial data provided to him during his recruitment 'did not accurately portray funds available to the dean for discretionary use. In retrospect, I can see how these presentations might have misled you and influenced your decision to accept the offer from UCSF. I regret this circumstance and apologize on behalf of the university.'

Furthermore,

Kessler said he relied upon detailed financial information shared with him by Jaclyne W. Boyden, who was then the medical school's vice dean for administration and finance. In a letter dated March 31, 2003, she said the dean's office had about $50.6 million in available funds in 2001-02 and was projected to receive about the same amount the following year.

That June, the school provided him with updated figures showing revenue was actually $46.4 million in 2001-02 and projecting revenue of $47.1 million in 2002-03.

But in December 2004, after Kessler had hired his own chief financial officer, he said he received new financial statements that greatly troubled him. The actual revenue in 2001-02 was only $28.3 million and revenue in 2002-03 was less than that.

'I get the December spreadsheet and I say, 'What's going on here?' ' he said. 'This thing looks all negative now.'

The next day, another article in the Los Angeles Times suggested that while Dr Kessler seemed willing to try to come up with some solution to the financial disagreements, the university was not interested,

During a three-hour interview Saturday at a San Francisco-area hotel, Kessler described the behind-the-scenes tension that he said led to his termination. He pointed to three actions he took that he believed may have played a role.

First, in April, he sent an e-mail to a university lawyer accusing the UC auditor of 'obfuscation or worse.' Then, he said, he provided a UC regent, whom he would not name, with documentation to support his allegations of financial improprieties. And finally, he called a meeting in April to share information about the financial position with medical school chairs and senior school leaders.

'It was clear that the university did not like us doing this,' Kessler said, referring to the chairs meeting. 'The chancellor was very upset.'

[Medical school Executive Vice Dean Keith R.] Yamamoto and Jed Shivers, the medical school's former vice dean for administration, finance and clinical programs, said Kessler was genuinely interested in finding a solution.

Shivers said he resigned in April to take a job in New York, in part because of the ongoing turmoil. He had worked with Kessler when Kessler was dean at Yale University School of Medicine, before coming to UCSF.

'My opinion is that they've resisted at every step of the way to really get to what occurred here,' Shivers said.

Yamamoto said he was baffled that the two sides couldn't work it out.

'David did everything that he could to actually solve the problem, to reach a resolution without anything blowing up,' he said. 'I believe he presented many options that could have gotten there, but they were rebuffed.'

Obviously there is an element of "he said, he said" in this story. In my personal opinion, Dr Kessler seems to have supplied the media with more evidence supporting his version of events than have the top UCSF leadership that fired him. In any case, the story suggests something was seriously wrong in the management of UCSF, whether it was attributable to the now former Dean (seemingly less likely), or to other university adminstrators (seemingly more likely).

We have not recently posted about problems in the leadership of UCSF, one of the US' premier medical schools. However, we posted quite often in the past about issues about the leadership of the University of California system as a whole (most recently here), and about the leadership of the University of California - Irvine (UCI) medical school (most recently here). It seems now a long time ago, but UCSF was the locus of the first more or less well-publicized stories from the 1990s about suppression of medical research (the "thyroid storm" case, see the Scientific Misconduct blog post here for its references, and the editorial in JAMA by Drummond Rennie [Rennie D, "Thyroid storm" JAMA, Apr 1997; 277: 1238 - 1243].)

Again, this is one more link in the chain of evidence that something serious has gone wrong with the leadership of major health care institutions. Now what are we going to do about it?

ADDENDUM (17 December, 2008) - see some comments on Wachter's World blog.

More RUC Muck-Raking

We have posted a number of times, most recently here, about the RBRVS Update Committee's (RUC) responsibility for Medicare's relatively poor reimbursement of primary care and other "cognitive" physicians' services compared to procedures. This imbalance has rippled through all of US health care, affecting how private insurers and managed care organizations reimburse physicians, and generally how the US systems favors procedures over talking, examining, thinking, diagnosing, prognosticating, deciding, and prescribing and super-specialization over generalism and primary care. The RUC ostensibly is just an advocacy group sponsored by the American Medical Association, yet it seems to be the only source of outside input about physicians' reimbursement used by the US Center for Medicare and Medicaid Services (CMS). Given this influence, it is dismaying that it is secretive, unrepresentative, and unaccountable. Neither its membership nor proceedings are public. It is dominated by proceduralists and sub-specialists. It is unaccountable to US physicians, much less the general public.

The importance of the RUC and the damage it does is being more widely recognized. Most recently, on the influential Health Care Blog, Brian Klepper spreads the word about the RUC, but suggests that only when the public and policy makers become aware of this problem will we be able to contemplate a solution.

Another Day, Another Deferred Prosecution Agreement

As I mentioned earlier, a major impetus for setting up this blog was finding out that most physicians knew local examples of badly or corruptly run local health care organizations, and felt that their core values were threatened by the actions of these organizations. However, the doctors all felt they were peculiarly unlucky to practice in such a uniquely sleazy environment. They did not realize that things were likely just as bad in the next town, and thus, that the problems were systemic. When I have taken my Health Care Renewal talk on the road, only a few people in the audiences have ever heard of some of the most vivid examples of bad health care organizational governance, e.g., the collapse of the Allegheny Health Education and Research Foundation (see post here).

So it may be easy to dismiss the next story as just the sort of corruption that goes on in our little state of Rhode Island. But remember that the something similar is likely going on in your cities, states, and countries.

Starting with one of the first posts on this blog, we began to recount the follies of the management of Blue Cross and Blue Shield of Rhode Island (BCBSRI), a not-for-profit insurance company and managed care organization, the dominant health insurer in the state. In 2004, Blue Cross "fired its CEO this year after news reports of his huge salary, receipt of a $600,000 no-interest loan which he did not pay back, and, receipt of free acupuncture treatments from a practitioner who wanted to influence Blue Cross reimbursement policies. Meanwhile, Blue Cross was paying health care professionals poorly (often less than Medicare), while hiking premiums at double-digit rates." (See post here.) In 2005, the company settled a class action suit after it was accused of "bilking subscribers" by using a complex scheme to inflate their drug co-payments (see post here). In 2007, a former RI state senator pleaded guilty to literally being a Blue Cross "bag man," being paid for many more bags than he actually delivered to the company in return for promoting legislation favored by it (see post here).

Today, the Providence Journal reported that four high-ranking Blue Cross executives resigned in connection with "an expected announcement ... by the health insurer and the U.S. Attorney's office." They included Lynne A Urbani, who "was promoted to senior vice president for external services, taking on oversight of community services along with her prior responsibilities over customer, provider and medical services"; Matthew T Brannigan, "a former chairman of the East Greenwich Republican Town Committee, [who] joined Blue Cross in 1996 and had also been promoted earlier this year, from vice president to senior vice president for sales and marketing"; Scott A Fraser, "vice president for government relations, and also served for years as Blue Cross’ spokesman"; and Brian Jordan, "who was assistant vice president for government relations."

Then, a news release from the US Department of Justice revealed the Blue Cross had entered into a deferred prosecution agreement with the government. In it, the company acknowledged its conduct, including:

BCBSRI acknowledged in the agreement that while lobbying [former Rhode Island state Senator] Celona on legislation, its executives caused the insurer to pay $74,000 to a communications company to produce a cable access program hosted by Celona. Celona was paid $13,565.

Likewise, BCBSRI acknowledged that, while its executives were lobbying [former Rhode Island state Senator] Martineau on legislation, members of the insurer’s executive management caused the insurer to pay about $175,500 to a business run by Martineau for the purchase of paper prescription bags.

BCBSRI further acknowledges that it paid $400,000 in insurance brokerage commissions to an unidentified former Rhode Island Senate President while its executives were lobbying him concerning legislation.

The company took responsibility for these actions.

BCBSRI acknowledges and accepts responsibility for conduct of certain former executives, who caused the payments in question to be made, knowing that its executives were lobbying the legislators. The company also acknowledges that the executives were acting within their apparent authority as executives of Blue Cross Blue Shield of Rhode Island.

The nature of the deferred prosecution agreement was explained.

As part of the agreement entered today, BCBSRI will continue to cooperate fully with the government’s ongoing investigation. As long as BCBSRI complies with the terms of the agreement, the government agrees not to criminally prosecute BCBSRI for any conduct described in the agreement and in the plea agreements of the former state senators.

The company agreed to pay a fine, and revise its operations.

Under the terms of the non-prosecution agreement, BCBSRI has agreed to pay $20 million to the government and not to seek any rate increases specifically to recoup the $20 million. The money will go into a fund to be administered by the Rhode Island Foundation. The earnings and interest from the $20 million fund will be used to support projects designed to provide quality, affordable health care services in Rhode Island.

BCBSRI has also agreed to a series of ethical reforms that it has already implemented and will maintain. These reforms include: compliance oversight by a Corporate Compliance and Ethics Committee; a full time corporate compliance officer and ethics department; a code of ethics governing the conduct of directors, officers and employees; and ethics training programs. The insurer also agrees to hire a government-approved monitor to oversee its ethics reform and its compliance with the agreement. The monitor will be in place for at least two years.

Meanwhile, the Providence Journal also reported that the current chairman of the board of Blue Cross, Frank J Montanaro, has been accused of a conflict of interest apparently unrelated to the deferred prosecution agreement. Montanaro, who also is head of the Rhode Island State Association of Firefighters and president of the Rhode Island AFL-CIO labor union, served on an arbitration panel which had to decide on the health care benefits for Providence city fire-fighters. Montanaro was on the panel ostensibly to represent the fire-fighters' interests. Yet, he "argued during the arbitration that the city needed to stay with Blue Cross because a change would result in a disruption for the firefighters, but he never disclosed his connection, or that granting that clause would guarantee millions in business for his company." The arbitrator who represented the city's interests asserted, “Frank shouldn’t even be having this discussion with us. Because Frank is biased. Frank is on the board of Blue Cross. How can the chairman of Blue Cross sit here and impartially and objectively decide on this?”

So, another day, another set of executive resignations, another conflict of interest and another deferred prosecution agreement for a big (at least for little Rhody) health care organization. (This is, by the way, the second deferred prosecution agreement imposed on a big health care organization in the state. See our previous post on the agreement affecting the Roger Williams Medical Center.) Is it any wonder that honest health care professionals in this state are demoralized?

That one small state has had two such agreements in two years, and, of course, all the mismanagement and malfeasance we have documented now for three years on Health Care Renewal, suggests that the US, and most likely other countries, have big systemic problems with unethical health care practices and bad health care governance. But as Transparency International noted, health care corruption for a while has been the unacknowledged elephant in health care's living room, raising costs, stifling access, and degrading quality.

How many more such stories will it take for the remaining honest physicians to demand that we throw sunlight on the infestations and drain the swamps of corruption? Will the public and policy-makers ever notice?

By the way, although cases like that of Rhode Island Blue Cross at least serve to exemplify the problems, the failure so far of anybody at Blue Cross to lose more than their current jobs as penalties for their actions suggests that there is still little deterrence for malfeasance in the health care sphere.

Government calls for licensing requirements for HIT developers/vendors?

If this story is true, perhaps it is a good thing. I particularly like the idea of banning health IT advertising to doctors, and especially the idea of licensing requirements for those selling or promoting (I'd also add developing) HIT products.

My only request: can I help design the licensing exam?

It would be designed especially to root out the "usual suspects", e.g., shiny-haired, impressive-sounding, but otherwise incompetent "experts", "process jocks" and "process babes" with tunnel vision who believe the whole world operates like a Model T assembly line and create fiascos like this one, snake oil salespeople, and Medical Instamaticists, among others - although with a bit more finesse than used by Keyser Söze:

Health IT breakthrough possible in Washington by Eric Novack

Dec. 13, 2007

Unnamed senior officials at CMS confidentially report that serious bipartisan discussions are ongoing to help get the Health IT bill completed.

“Electronic medical records and e-prescribing, if mandated throughout the country, would save thousands of American lives each year”, one CMS official stated [as long a physicians are not coerced to be the venture capitalists and R&D arm/beta testers for the HIT companies as I posted here - Ed.]

A senior Democrat house staffer, speaking on condition of anonymity, said that the leadership thinks that the current situation, where dozens of private companies are aggressively competing against one another to get a foothold in the world of health IT, is counterproductive, wasteful, and costing lives.

“Venture capital and the drive for profits is a distraction that this country, with 47 million uninsured, can simply not afford.”

Proposals apparently under consideration include banning advertising of health IT to doctors, licensing requirements for anyone involved in the sale or promotion of health IT products, and a special ‘health IT tax’ on health IT companies which would allow the Office of the National Coordinator of Health Information Technology (ONCHIT) to distribute funds to areas of the country that lack a health IT infrastructure.

Calls to House Speaker Nancy Pelosi (D-CA) for comment have not been returned.

I first called for greater control of the HIT field almost a decade ago here (warning: crude, un-updated web page at that link):

... Healthcare IT seems to be a largely unregulated industry in terms of qualifications and certification, exactly opposite to medicine. (Imagine if anyone could practice medicine, if they were able to get enough "experience" through reading books or attending a varying number of unregulated training classes and "on the job" training.) Further, there are no standardized metrics of performance in clinical computing as there are in delivery of medical care, such as physician report cards showing morbidity and mortality rates.

At the beginning of the 20th century, medical education and practice was largely unregulated. In 1910 the Carnegie Foundation published the Flexner report which depicted a lack of admission and curriculum standards in medical education and accreditation, and poor quality facilities among medical education institutions. Flexner's report stimulated system-wide reform in medical education with programs integrating a scientific base and government implementing rigorous testing and certification boards to protect the public.

In January, 1995, the Standish Group reported that 52% of IT projects overrun their initial budget estimates by 189%, and 31% are canceled before completion. A report published in Computerworld (June, 1998) stated that 63% of large IT projects are delivered late and 58% are brought in over budget. Even more damning is the report in The Wall Street Journal (April 30, 1998) which states, "42% of corporate information-technology projects were abandoned before completion." In medical terms, the mortality rate of IT projects is too high. A sobering thought when one considers that each year in the USA, information technology projects are launched at a cost of $250 billion. (From a report by Gopal K. Kapur, Center for Project Management, Palm Desert, Calif.)

A story in the newspaper USA Today, "When Computers Fail" (Dec. 7, 1999), puts the cost of IT failures at $100 billion per year in the United States. Significant, expensive IT implementation failures at varied organizations such as Nasdaq, Hershey Foods, Whirlpool, state agencies, and the Pentagon are cited as just a few examples.

Notes one technology consultant in this story, "There's this mystique that these systems are managed and built by the most qualified pros on the planet. But most [I.S. personnel] are just regular Joes who aren’t measured for any standards about what they know. If you can program your Nintendo and can do a good selling job, you’re a hot commodity."

... Such a lack of standards on education and accreditation for healthcare IT workers contributes to healthcare IT's morbidity and mortality, and is likely to contribute to patient morbidity and mortality as well. At the same time, a milestone Nov. 1999 report "To Err is Human: Building A Safer Health System" from the Institute of Medicine (of the U.S. National Academy of Sciences) describes almost 100,000 deaths each year as a result of preventable medical errors. The report indicates that such errors are often caused by information-related problems (such as illegibility and unavailable or inaccurate records) at the point of care. Corrective measures at a national level are being recommended. Success and quality in healthcare IT are imperatives in correcting this problem.

Considering the critical nature of healthcare, standards of accreditation for those who want to work in clinical computing settings, and metrics for performance, will be of significant benefit. Healthcare accrediting agencies such as JCAHO (Joint Commission on Accreditation of Healthcare Organizations), American Medical Association, etc. should consider requirements for healthcare IT workers involved in clinical computing, and perhaps move towards basing accreditation of hospitals on the presence and proper roles (i.e., authority) of medical informatics-trained clinical personnel.

I stand by those words today.

-- SS

BLOGSCAN - Tough Policy Proposals About Conflicts of Interest

On the Clinical Psychology and Psychiatry blog, this post discusses the remarkable article by the Task Force on External Funding of the American Psychological Association. The article provides a good summary of the problems entailed by "Corporate Funding and Conflicts of Interest," (its title) and gives some remarkably tough policy suggestions to the APA. The anonymous blogger speculated on the likelihood that advice will be taken.

Relman in JAMA on Threats to Physicians' Core Values

The purpose of the Health Care Renewal blog is to address "threats to health care's core values," as noted in our side-bar.

The latest issue of JAMA contains an important article by Arnold Relman on this topic.(1) Much of its content will be very familiar to Health Care Renewal readers.

Relman's first point is that physicians' core values are threatened:

Endangered are the ethical foundations of medicine, including the commitment of physicians to put the needs of patients ahead of personal gain, to deal with patients honestly, competently, and compassionately, and to avoid conflicts of interest that could undermine public trust in the altruism of medicine.

These threats arise from "the growing commercialization of the US health care system." This has been abetted by physicians who accept "the view that medical practice is also in essence a business." Thus, "the vast amount of money in the US medical care system and the manifold opportunities for physicians to earn high incomes have made it almost impossible for many to function as true fiduciaries for patients."

Relman also the growth of specialization, and the "greater economic rewards of procedural specialties," although he did not address why procedures have come to be better rewarded.

I think Relman's most important insights were about how legal changes in the US have undermined professionalism.

The law also has played a major role in the decline of medical professionalism. The 1975 Supreme Court ruling that the professions were not protected from anti-trust law7 undermined the traditional restraint that medical professional societies had always placed on the commercial behavior of physicians, such as advertising and investing in the products they prescribe or facilities they recommend. Having lost some initial legal battles and fearing the financial costs of losing more, organized medicine now hesitates to require physicians to behave differently from business people. It asks only that physicians' business activities should be legal, disclosed to patients, and not inconsistent with patients' interests. Until forced by anti-trust concerns to change its ethical code in 1980, the American Medical Association had held that 'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients' and that 'the practice of medicine should not be commercialized, nor treated as a commodity in trade.' These sentiments reflecting the spirit of professionalism are now gone.

Finally, Relman blames the "growing influence of the pharmaceutical industry," noting that the industry

uses its enormous financial resources to help shape the postgraduate and continuing medical education of physicians in ways that serve its marketing purposes. Physicians and medical educational institutions aid and abet this influence by accepting, sometimes even soliciting, financial help and other favors from the industry, thus relinquishing what should be their professional responsibility for self-education. A medical profession that is being educated by an industry that sells the drugs physicians prescribe and other tools physicians use is abdicating its ethical commitment to serve as the independent fiduciary for its patients.

It is striking that the notion that physicians core values are under external threat is now becoming mainstream.

Hearing from multiple physicians about their central concern "with the abandonment of the core values of medicine,"(2) prompted us to start planning for what eventually became this Health Care Renewal blog. In my European Journal of Internal Medicine article, I summarized these values from some prominent codes of medical ethics: they required "that the physician put the patient's interests first, and then require that the physician practice with honesty and integrity, to uphold the confidentiality of information about individual patients, and to be responsible for the education of the next generation of physicians." The more modern codes also required the physician "to commit to scientific medicine."

However, I wish this essay had considered a broader formulation of the causes of the current crisis.

On one hand, Relman did not discuss how the government runs its part of health care could have some responsibility for the current crisis. In particular, on Health Care Renewal, we have discussed, most recently here, how the US Medicare system allows its physician reimbursement, which heavily favors procedures over primary care, to be determined by a secretive committee, the RBRVS Update Committee, or RUC, dominated by proceduralists and sponsored by the AMA, the same organization that once condemned the commercialization of medicine. It turns out that Relman has just written a book (reviewed here) about how to reform health care, in which he advocated for a government run single-payer system. The notion that Medicare, our current government run single-payer system (albeit only for the disabled and the elderly) may be to blame for much of the current system's problems makes this position harder to defend.

On the other hand, although Relman decried the commercialization of health care, he focused on only one sector, the pharmaceutical industry. Although pharma has had its share of abusive leaders and practices, other sectors, including biotechnology, medical devices, health care insurance and managed care, health care information technology, etc, etc have not done much better (just page through Health Care Renewal for examples.)

On the third hand (oops), Relman came close to excusing the conduct of not-for-profit organizations within health care. He wrote only, "to survive in this new medical market, most nonprofit medical institutions act like their for-profit competitors, and the behavior of nonprofits and for-profits has become less and less distinguishable." Again, Health Care Renewal (and many others) have noted incompetent, conflicted, and even outright criminal leadership of many not-for-profit health care organizations, including some of our most revered. Relman's book, however, advocates that health care delivery be turned over to not-for-profit organizations. Doing so might provide little benefit unless we take drastic steps to improve not-for-profit governance, an issue which I am not sure the book addressed.

In summary, Relman's commentary should help shake awake those who keep thinking that US health care is the best in the world. It should also remind us how different things were only a generation ago. If only physicians still agreed that "'the practice of medicine should not be commercialized, nor treated as a commodity in trade," and that "'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients." (For more discussion of the history of the AMA's former opposition to commercialization of medicine, see Money-Driven Medicine by Maggie Mahar.)

References

1. Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here]
2. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123–130.

The Avandia Case, and a Warning About How Bad Things Can Get

We have posted frequently about the controversy about rosiglitazone (Avandia, by GlaxoSmithKline). Some of the distressing aspects of the case were various efforts made to keep information and opinions unfavorable to Avandia away from physicians, the patients, and the public, including efforts involving obfuscation, deception, and intimidation. (For example, see this post about the "spinning" of Avandia and the ridiculing of Avandia critics, and this post about attempts to silence an early Avandia critic.)

This month, the British Medical Journal printed a news article about the US Senate report that claimed that the critic, Dr John Buse, was intimidated by top GSK executives.

Perhaps with deliberate irony, on the same page was another news article, headlined, "One in 20 East German doctors spied on patients or colleagues." It was based on a study by the Hannah Arendt Institute for Research on Totalitarianism,

About 5% of doctors in the former East Germany spied on their colleagues or patients as unofficial members of the East German secret police (the Staatssicherheit or Stasi), a new report has shown.

The study, by the Hannah Arendt Institute for Research on Totalitarianism, Dresden, and commissioned by the German Medical Association and the German medical journal Deutsches Ärzteblatt, showed that the percentage of unofficial members of the Stasi among doctors was higher than in the East German population as a whole.

'Doctors were one of the main targets of the Stasi because they were thought to belong to a reactionary class and were thought to be especially interested in escaping to West Germany,' said Francesca Weil, author of the study....

Of those doctors who were unofficial spies, about a quarter passed on information not only about colleagues but also about their patients' health and private lives. Psychiatrists and sports medicine experts were the most common specialists among the unofficial spies, and a third of them held a leading position in a hospital. The Stasi also recruited medical students.

Reasons for spying varied. Some doctors were trying to advance their career or were afraid that their careers would suffer if they did not participate; others were committed socialists; and another group liked the economic advantages, which ranged from monthly cash payments to fast tracked delivery of a car or other luxuries.

In my humble opinion, physicians in the West should not view the latter article as affirmation that we do not have things so bad. Rather it is a warning about how bad things can get.

Doctors are not the venture capitalists and R&D arm of Acme EMR Corporation (with apologies to Linda Lovelace)

We have now reached the point where clinicians are being pushed from every side - industry consortia, government, patients, etc. to adopt clinical IT, often at their own cost and risk. Even suggesting that clinical IT may not be all it is cut up to be can result in highly emotional and unhappy feedback from various circles. It seems to be like suggesting God does not exist to the Vatican.

It also seems never to have occurred to the pundits that doctors are not the venture capitalists and R&D/beta testing arm of the Acme Anvil EMR Corporation.

I am a strong proponent of good Electronic Medical Records and related clinical IT (CPOE, CDSS, etc.) as tools to facilitate an improved quality of healthcare. However, several caveats apply:

1. The keyword is "facilitate." It must never be forgotten that the key to good healthcare is smart, well-trained, well-rested, well-compensated experts who treat patients from a framework of peace of mind. Believing you can reliably get good healthcare -- from frazzled clinicians whose practice is a nightmare due to paperwork, frequent battles with payers over minutiae, perplexing EHR's with which they are (apologies to Linda Lovelace) deep-throated by overzealous hospital and IT executives, vendors and governmental agencies, threats of reimbursement cuts and lawsuits, etc. -- is the belief of a fool. Clinical IT does not work cybernetic miracles; and another rule of thumb is that "Computer + Quack ≠ Marcus Welby." (≠ is the symbol for "does not equal.)

2. Another keyword is "good." Health IT can only facilitate improved healthcare if it itself is good. It must be designed via the principles of (at the very least) resilience engineering at the forefront:

The term Resilience Engineering represents a new way of thinking about safety. Whereas conventional risk management approaches are based on hindsight and emphasise error tabulation and calculation of failure probabilities, Resilience Engineering looks for ways to enhance the ability of organisations to create processes that are robust yet flexible, to monitor and revise risk models, and to use resources proactively in the face of disruptions or ongoing production and economic pressures. In Resilience Engineering failures do not stand for a breakdown or malfunctioning of normal system functions, but rather represent the converse of the adaptations necessary to cope with the real world complexity. Individuals and organisations must always adjust their performance to the current conditions; and because resources and time are finite it is inevitable that such adjustments are approximate. Success has been ascribed to the ability of groups, individuals, and organisations to anticipate the changing shape of risk before damage occurs; failure is simply the temporary or permanent absence of that.

In that regard, committees led by unidisciplinary IT personnel, focus on process by "process babes", consensus, systems lifecycle, and other characteristics and methodologies of management information systems and "merchant computing" do not reliably produce good clinical IT. In fact, often the opposite is true.

The rigor that transformed medical education and practice into a more scientific endeavor, initiated by the Flexner Report of 1910, needs to be applied to clinical IT. I personally demand the same rigor of health IT developers and managers that citizens demand of their clinicians. Is that unreasonable, I ask?

3. Clinical IT must be "evidence-based." As in my posts here and here and at my website here, the evidence is not entirely rosey. (I would venture to say the negative indicators are even more concerning than the corresponding indictors for, say, a drug like VIOXX.)

I have noted something peculiar about the changing role of Medical Informaticists as well.

Things are moving backwards.

A decade ago I was sought out to help a large medical organization choose the EMR product(s) best-suited to their various departments, specialties, and culture(s), and then assist in the implementation, customization, and culture changes required for its use.

A decade later (i.e., now), I find myself sought out to help large medical organizations who've pre-selected EMR's, often with the major say residing outside the clinicians and using a "one vendor fits all" approach, to help shove the products down clinicians' throats by pursuasion or coercion if needed. The requirement to continue medical practice and be a part-time CMIO and "Director of Clinician Gag Reflex Suppression" may be, I believe, reflective of this new phenomenon.

I also wonder if the emergence of CCHIT, the Certification Commission for Healthcare Information Technology that "certifies" features of clinical IT products pre-flight-checklist style (good in concept) is having unexpected consequences, as the field of social informatics predicts of any new ICT (information & communications technology) 'revolution.'

Could CCHIT be further facilitating the groundswell in recent years of an "irrational exuberance" and loss of critical, evidence-based decision making by hospitals regarding EMR's? Could CCHIT "certification" be encouraging hospitals to (incorrectly) believe they can skip or skimp on the "selection and evaluation" phase and jump right to purchase, and then hire an informatics expert after the fact to "change the culture?" Although CCHIT does not guarantee overall quality, usability and ultimate success of any product (in a nutshell, CCHIT merely confirms the presence of features), this could explain the "backwards leap" in the CMIO role I've noticed recently.

Finally, I believe the following questions need to be asked, asked again, and asked again.

• Does clinical IT fix the problems it is purported to fix? If not, why not?
• Is it consistently designed and implemented utilizing the best practices known to experts in engineering, medical informatics, HCI, and other areas, and if not, why not? Are the methodologies employed the same as the methodologies used for merchant computing, and if so, why, and what is the evidence this is the best path forward?
• Are its drawbacks, both potential and observed, discussed openly, thoroughly and critically? If not, why not?
• Are those who raise these issues praised, or attacked (e.g., as in Ross Koppel's work on CPOE being called "disingenuous" in print). If they are not praised, why not? If they are attacked, what are the true interests and agendas of those engaged in the attack?

Sometimes it appears the health IT industry reverses the roles of enabler of healthcare and facilitator of healthcare. Ultimately, though, patients do not fall ill, and clinicians do not toil in hospitals, so that the IT industry can have great computers, comfortable careers and watershed profits.

-- SS