Conflicts of Interest: All in the Family

In the last week two stories surfaced about conflicts of interest within health care organizations that involved family ties.

The St Jude Sales Representative and the Jackson Memorial Chief Cardiologist

The first one was in the Miami Herald. The basic elements were as follows. Monica Rodriguez was a representative first for Medtronic, specializing in implantable cardiac devices. She had been a patient of Dr Alberto Interian Jr, who was interim chief of cardiology at Jackson Memorial Hospital, a major teaching hospital for the University of Miami. Rodriguez had listed Interian "as a recommendation on her application to Medtronic." Rodriguez quit Medtronic in May, 2004. " That summer, Interian and Rodriguez say, they began seeing each other socially." Interian first urged Medtronic to re-hire Rodriguez, then urged Guidant to hire her. Finally, she took a job with St. Jude Medical. Then, suddenly, sales of St. Jude devices to Jackson Memorial increased. "In the final four months of 2004, Jackson paid $499,145 to Medtronic, $405,750 to Guidant and $166,000 to St. Jude. That changed. Starting in February 2005, St. Jude sales led the other two for the next six months. In 2005, investigators say, St. Jude's sales at Jackson increased about $2 million. Medtronic's fell about $2 million at Jackson and about $1.8 million at the VA hospital. Guidant didn't offer figures but said sales fell."

Soon, Rodriguez and Interian's ongoing relationship was revealed. A Medtronic manager "received a call from a sales rep who handled Medtronics accounts at Jackson: 'She was incensed. She . . . said they were dating. She said, `We are going to lose our shirt.' . . . She started losing business right away.'' Then, "In June 2005, anonymous letters faxed to UM President Donna Shalala and Jackson chief executive Marvin O'Quinn revealed the romance and the shift of sales to St. Jude."

Then, "On Aug. 16, UM's internal audit department decided there was ''at the very least, a possible perception of conflict of interest.' The UM report indicated Interian said 'it's a coincidence that he's come to view [St. Jude] as better since he started dating her.'" Apparently, Interian and Rodriguez decided she should stop working at Jackson Memorial. However, her departure was delayed. "On Nov. 17, Interian's boss, Laurence B. Gardner, fired off a heated e-mail to Interian: 'Al, the board of trustees has told me your 'friend' still has Jackson. I would remind you that is exactly the opposite [of what] you told me.''' Then Interian was fired as interim chief of cardiology. "Eventually, Rodriguez left Jackson but kept working at Mercy Hospital, where Interian operates under a contract as medical director of the Arrythmia/Syncope Center. In April, ethics investigators Karl Ross and Kennedy Rosario submitted a report noting that taxpayer dollars had been spent at Jackson and that the county code states no person 'shall use or attempt to use his official position to secure special privileges or exemptions for himself or others.' The report concluded that the 'primary beneficiary' of St. Jude's rise in sales was Rodriguez, who earned more than $100,000 from sales to Interian's department at Jackson alone, along with tens of thousands at other hospitals where he worked."

The FDA Manager and the Platinum Solutions Advisory Board Member

The second story comes from the Los Angeles Times. Margaret "Margo" Burnette was a senior manager at the US Food and Drug Administration (FDA). She was in charge of developing a new data system to handle industry applications for medical products. She was working with a contractor called ProObject Inc. to develop the system. In April, 2004, Burnette married Mark A Boster. "That same month Burnette was promoted to information-technology director. A top FDA official praised her as a 'very successful leader.' Boster, who was working full-time with another technology contractor, joined Platinum Solutions [Inc.] ' advisory board about then. He was paid a retainer and fees for attending meetings, he said." At about the same time, "Burnette was making no secret within the FDA of her displeasure with ProObject." The agency did not obtain a satisfactory replacement through the competitive bidding process. "At that point Burnette conferred with her husband and steered her deputy, James Shugars, to contact Platinum Solutions." Then, "Once Platinum Solutions was aboard, Burnette said, she assigned Shugars to handle 'contract issues' directly with the company. Shugars briefed her regularly, she said. [Burnette's supervisor James J] Rinaldi said that Shugars voiced concerns to him and was 'very, very nervous' about managing the data project while reporting to Burnette. I think he was concerned about just the overall conflict of interest,' said Rinaldi, now chief information officer at the federal Jet Propulsion Laboratory in La Cañada Flintridge. 'Obviously that was because of the spouse.' Rinaldi confirmed that the FDA awarded the initial contract to Platinum Solutions without competition, a move that hinged on the company's special status as a disadvantaged business."

"In June 2005, Burnette said she relinquished any role with the data project because about two months earlier her husband had become a full-time executive with Platinum Solutions. In addition to salary, Boster's new position placed him in line for extra pay when the company's revenue increased, he said. 'Since he was actually working there as the chief operating officer, the perception would have been just too bad,' Burnette said. 'It would have appeared that I would have had some influence.' This year, the FDA sought competitive proposals for the completion of its data system. On Nov. 27, Platinum Solutions said that it won the contract. Although Burnette said she no longer oversees the project, she helps shape technology priorities from the FDA commissioner's office. Her husband said that he was in charge of Platinum Solutions' performance on all ongoing contracts, including with the FDA."

There is no report yet of any official response by the FDA to all this.

Comments

It seems that if we search, we may find every possible species of conflict of interest affecting large health care organizations. It also appears that organizations that have issues with any one type of conflict are likely to have issues with other types. For example, we previously posted about apparently major conflicts of interest affecting the President of the University of Miami, Jackson Memorial's parent university. And we very recently posted about conflicts of interest affecting members of FDA scientific advisory panels.

One wonders how practicing physicians and other health professionals in the trenches, much less the public at large would react if all such conflicts were fully disclosed.

The pervasive web of conflicts that spans many of the large organizations that now dominate health care suggest that much of the health care system may operate more for the private benefit of its insiders than to actually improve the health of the public.

Lilly's Dubious Marketing of Zyprexa

The New York Times published articles yesterday and today about how Eli Lilly and Co. marketed its best-selling anti-psychotic drug, Zyprexa (olanzapine). The articles revealed several issues.

Lilly's Marketers Minimized the Risks of Obesity and Diabetes

In particular, (quotes from yesterday's article somewhat re-ordered):

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents [supplied to the Times], which cover the period 1995 to 2004.

Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.

The documents show that Lilly encouraged its sales representatives to play down those effects when talking to doctors. In one 1998 presentation, for example, Lilly said its salespeople should be told, 'Don’t introduce the issue!!!'

To reassure doctors, Lilly also publicly said that when it followed up with patients who had taken Zyprexa in a clinical trial for three years, it found that weight gain appeared to plateau after about nine months. But the company did not discuss a far less reassuring finding in early 1999, disclosed in the documents, that blood sugar levels in the patients increased steadily for three years.

But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales.

'Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule, Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an 'executive steering committee for olanzapine-associated weight changes and hyperglycemia.'

At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that 'unless we come clean on this, it could get much more serious than we might anticipate,' according to an e-mail message from one Lilly manager to another.

Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness.

Not surprisingly, Lilly spokespeople did not agree with the Times' assertions.

On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use.

Lilly's Marketers Promoted Zyprexa for Unapproved Uses, Particularly Dementia
According to the second article,

Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

In the [promotional] campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis.

Yet in 1999 and 2000 Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors 'do treat dementia' but 'do not treat bipolar; schizophrenia is handled by psychiatrists.'

As a result, 'dementia should be first message,' of a campaign to primary doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically.

Later, the same document says that some primary care doctors 'might prescribe outside of label.'

As part of the 'Viva Zyprexa' campaign, in packets for its sales representatives, Eli Lilly created the profiles of patients whom it said would be suitable candidates for Zyprexa.

The third patient was 'Martha,' a widow with adult children 'who lives independently and has been your patient for some time.' Martha was described as being agitated and having disturbed sleep, but without the symptoms of paranoia or mania that typically marked a person with schizophrenia or bipolar disorder.

[Lilly spokeswoman] Ms. Nobles said that Lilly had actually intended Martha’s profile to represent a patient with schizophrenia. But psychiatrists outside the company said this claim defied credibility, especially given Martha’s age. Instead, she appeared to have mild dementia, they said.

This appears to be yet another sad tale of how marketing enthusiasm has been given free rein in the pharmaceutical industry, unopposed by any sense of the evidence of particular drugs' benefits and risks.

This is another reminder about how skeptically physicians ought to view the marketing of health care goods and services.

Note that several other health care bloggers have commented on this story (See Medrants, Retired Doctor's Thoughts, and Clinical Psychology and Psychiatry). But given the size of the company involved, and the popularity of the drug, it seems worthy of all this attention.

Johns Hopkins President (and Medtronic Director) Claims Right to Punish Speech He Deems "Not Substantive and Serious"

Manifestation of concentration and abuse of power that we discuss frequently on Health Care Renewal are attempts to suppress free expression. These attempts are usually directed at expression that those in power find offensive. Two recent examples include: attempted suppression of clinical research that suggested an increased incidence of adverse effects due to the drug aprotonin (most recent post here), and the prolonged silencing of a whistle-blower who questioned the financial conduct of a hospital CEO (see most recent post here). (The CEO was later convicted of fraud.)

Some insight into the thinking of those who attempt to suppress free expression in health care may come from a recent case at Johns Hopkins University, parent university for one of the world's most renowned medical schools and academic medical centers. The recent controversy started when a JHU undergraduate student posted an invitation on the web to a campus party which included crude language. Some found the language offensive, if not racist. It was not surpising that the student received fierce condemnation. However, the university then charged him with “failing to respect the rights of others and to refrain from behavior that impairs the university’s purpose or its reputation in the community,” violating the “university’s anti-harassment policy,” “failure to comply with the directions of a university administrator,” “conduct or a pattern of conduct that harasses a person or a group,” and “intimidation.” His punishment was a year's suspension, and that he complete 300 hours of community service; read 12 books and write a reflection paper on each; and attend a workshop on diversity and race relations.

The University's actions were condemned by the FIRE (Foundation for Individual Rights in Education), which has stood up forcefully for free speech and academic freedom in US institutions of higher education. A FIRE spokesperson stated, “Hopkins’ unconscionable treatment of [the student] ... should shock anyone who values free speech,” Furthermore, “Johns Hopkins must not be allowed to promise free speech to its students and then deliver heavy-handed repression.”

However, JHU President Dr William R Brody attempted to justify the university's actions in an article in the Johns Hopkins Gazette. Although he condemned past attempts by the university to suppress speech "of a substantive and serious nature," he then argued:

But I think we all know that it stretches our credulity to assert that two crude and tasteless invitations to a fraternity party posted on an Internet Web site rise to this standard of seriousness of purpose or intent. What I see here is not a courageous trespass of taboo speech but rather a fundamental breach of civility of the sort that is so commonly displayed in disparagement, mockery or epithets drawn along racial or ethnic lines. It is, simply put, common name-calling. This is what I believe we should agree is unacceptable in our community of free and open discourse. Let us not forget that true civility is not a program of fair treatment for this or that constituency but rather an underlying and fundamental commitment to showing respect for everybody.

So Brody asserted that only "substantive and serious" speech is protected. And Brody reserved to himself the right to determine what speech is "substantive and serious." Brody's "community of free and open discourse" would not protect discourse which its leader deemed to be only "common name-calling," or a "fundamental breech of civility." Yet, claims that free speech is protected ring hollow when the only speech protected is that which the powers that be find acceptable.

The Torch, the blog sponsored by FIRE, provided this telling quote from FIRE's Guide to Free Speech on Campus:

[John Stuart] Mill addressed one of the major rationales for imposing constraints on free speech on campuses today, namely that speech should be 'temperate' and fair.' Mill observed that while people may claim they are not trying to ban others’ opinions but merely trying to banish 'intemperate discussion…invective, sarcasm, personality, and the like,' they never seek to punish this kind of speech unless it is used against 'the prevailing opinion.' Therefore, no one notices or objects when the advocates of the dominant opinion are rude or uncivil or cruel in their denunciations of their detractors. Why shouldn’t their opponents be equally free to show their disdain for the dominant opinion in the same way? Further, Mill warned, it always will be the ruling orthodoxy that gets to decide what is civil and what is not, and it will decide that to its own advantage.

Although the particulars of the current case at Johns Hopkins University seem far afield from the issues of concern to Health Care Renewal, Dr Brody did not limit the application of his argument to party invitations posted by undergraduates to the internet. His ability to punish any speech not deemed to be sufficiently "substantive and serious" should thus give pause to anyone at JHU who might publish clinical research that could offend vested interests, blow the whistle on health care quality issues, or question hospital or university administrators. Dr Brody's ability to punish such speech also seems to contradict the University's mission statement, which aims to "foster independent and original research, and to bring the benefits of discovery to the world."

Finally, I should note that Dr Brody's writings may also give insight into how little leaders of commercial health care organizations respect free speech, free expression, and academic freedom. Note that Dr Brody leads not only Johns Hopkins University, but also, as a Director, Medtronic Inc, "the global leader in medical technology." According to Medtronic's 2006 proxy filing, Dr Brody's yearly compensation as Director is $80,000 in cash, and $70,000 in stock options. Dr Brody currently owns more than 72,000 shares or the equivalent in the company's stock (worth more than $3,900,000 at the stock price of $54.28 /share today). Yet, I wonder if he would regard any questions about whether this part-time job, entailing fiduciary responsibility to a company which has "research and/or business relationships" with JHU, and which "periodically makes donations and/or grants" to JHU, constituted an important conflict of interest as not "substantive and serious," but mere "common name-calling?" I doubt anyone at JHU will try to find that out.

Medical CME and Conflicts of Interest: GSK Funds Talks About Screening Pregnant Women for Herpes

The Wall Street Journal just published an article by David Armstrong about how continuing medical education (CME) often seems to serve the interests of its commercial sponsors. The focus of the article was on how GlaxoSmithKline funds speakers who seem to favor clinical policies that just might end up increasing the use of the GSK drug valacyclovir (Valtrex) for genital herpes infections. (See our recent post about the attempted suppression of a study comparing Valtrex to Famvir here.)

The article focused on talks given by Dr Zane A Brown of the University of Washington. To quote from the article,

Addressing doctors, medical residents and students at Ohio State University Medical Center in September, Zane Brown advocated a big change in prenatal care: testing all pregnant women for genital herpes.

Widespread testing would reduce herpes infection in newborns, said Dr. Brown, an obstetrician at the University of Washington medical school.

It also would probably lead to a rise in the use of herpes drugs by pregnant women. That would be a boost to GlaxoSmithKline PLC, which sells the top-selling herpes drug -- and which paid for Dr. Brown's lecture.

Glaxo says it doesn't market its herpes drug, called Valtrex, in any way for pregnant women.

Doctors, however, aren't restricted in how they use an approved drug, nor in what they can say about it in talks to other medical professionals. And currently, about 10 doctors are fanning out across the U.S. making the case for universal genital-herpes screening of pregnant women. Glaxo funds these talks by giving grants to hospitals and other institutions that host them.

The lectures are called continuing medical education, or CME. Doctors who attend earn credits needed to maintain their medical licenses. Drug makers increasingly use lectures and articles by outside doctors to get their message across, at a time when hospitals often restrict salespeople's access. The funding reflects a broader trend of drug companies trying to influence medical practice, not always with full disclosure of their role. However, Dr. Brown, speaking to doctors in Ohio in September, mentioned Glaxo's funding of the talk.

Dr. Brown says he gives two to three lectures a week advocating universal herpes testing for pregnant women, earning $1,000 to $2,500 per talk. He says his motive isn't money but a desire to reduce the number of babies born with herpes. Because his own university lacks the funds to pay for his lectures, he says, he has a relationship with Glaxo born of necessity. 'I am using them and they are using me,' he said recently as he waited to board a flight to Tennessee for a series of lectures at hospitals there.

A Glaxo spokeswoman said the company has no 'control over the selection of speakers or the material presented' at CME lectures it funds. In the case of the Ohio State lecture, a professor who organized it, Wayne Trout, said, 'We approached [Glaxo] and said we want to bring Dr. Brown in -- can you give us some funding?' Glaxo declines to comment on specific programs.

Dr Brown is not the only one getting into this particular act.

The message doctors get in continuing-medical-education lectures and Web sites clearly favors testing and treatment of pregnant women. An example is an online CME lecture provided by Medscape LLC last March. Medscape says it picked the herpes speakers -- Dr. Brown and another pro-screening doctor, Serdar Ural of the University of Pennsylvania -- from a list provided to it by Glaxo, which funded the event. Glaxo said there's nothing wrong with providing names of potential speakers and added that CME sponsors have ultimate control over who speaks.

In the lecture, Dr. Ural advocated giving antiviral medication to all pregnant women who test positive for herpes even if they show no symptoms. He acknowledged there wasn't a lot of evidence such a strategy works but said, 'What is the downside? If she takes medication for a couple of weeks, side effects compared to placebo are about the same.' Dr. Ural said he has given 11 Glaxo-funded talks this year, declining to say how much he has been paid.

David A. Baker, a professor of maternal-fetal medicine at the medical school at the State University of New York in Stony Brook, lectures on herpes for Medscape and also for a firm called Omnia Education. Omnia receives funding both from Glaxo and from Quest Diagnostics Inc., maker of a herpes test. Dr. Baker typically discloses he is a consultant to Glaxo. In a filing with the New York State Ethics Commission, he also reported owning Glaxo stock. Asked about his stockholdings, he declined to comment, through a spokesman.

The American Journal of Obstetrics & Gynecology published a study in March that promoted the use of Valtrex in pregnant women over a generic alternative or no treatment at all. Not mentioned was that co-author Richard Whitley, a pediatrician at the University of Alabama at Birmingham medical school, is a member of the Valtrex maker's speakers bureau.

Dr. Whitley said in an interview he didn't disclose this because he hadn't yet begun his work as a Glaxo speaker. Yet his university disclosure forms indicate he has been a speaker for Glaxo since at least 2003. Asked about this, Dr. Whitley said through a spokesman that 'my omission of mentioning serving as a speaker for GlaxoSmithKline was an honest and simple oversight, made because my involvement in this role is quite minimal as a regional speaker.'

The article noted that there is no strong evidence supporting screening of pregnant women for herpes. In fact, the US Preventative Services Task Force, which usually follows the evidence-based medicine process pretty closely, suggests that screening not be done.

We just seem awash this week in conflict of interest stories. In this one, we have academic physicians whose talks, at $1000 - $2500 a pop, which suggest aggressive screening for herpes with little evidentiary justification, which presumably could lead to aggressive use of anti-viral agents for patients who test positive, just happened to be supported by a pharmaceutical company that makes those anti-viral agents.

Again, this suggests, at the least, the need for much more thorough disclosure of conflicts of interest by, in this case, all those who give CME presentations. One wonders if audience skepticism would have been increased if Dr Brown announced before each talk the amount he was paid to give it, and the total amount he received from GSK in the previous year, and made it clear that the strategies advocated in his talk would tend to increase the use of Valtrex, which just happened to be manufactured by GSK.

In lieu of such policies, doctors attending CME talks given by supposedly impartial experts (or those reading articles or guidelines written by other supposedly impartial experts) need to be very skeptical about for whom these experts actually work, and whose interests their talks, articles, and guidelines actually support.

FULL DISCLOSURE - I participate in a more or less monthly Roundtable discussion published by Medscape on the web.

Another Tale of Conflicts of Interest: Kyphon, Kyphoplasty, and the Surgeon with Stock Options

Here we go again. The Cleveland Plain Dealer published an investigative report about financial entanglements between an orthopedic surgeon who advocated for a particular procedure, kyphoplasty, for treating spinal fractures due to osteoporosis, and the company, Kyphon Inc, that made the equipment used in the procedure. To summarize, using quotes from the Plain Dealer:

Back braces, bed rest and medications had been the mainstays for treating the estimated 700,000 spinal fractures a year in this country alone caused by osteoporosis and other conditions. Then, in the mid-1980s, doctors in France began experimenting with the concept of vertebroplasty.

The first vertebroplasty in the United States was performed in 1993. An orthopedic surgeon, Dr. Mark Reiley, soon developed the idea of using a balloon to improve results, and he co-founded Kyphon. The company's focus the first few years was to raise money and develop the instruments used in kyphoplasty.

Next, Kyphon needed studies with influential practitioners and institutions to demonstrate that the treatment worked.

[Dr Isadore] Lieberman began offering advice to Kyphon in 1997, the [Cleveland] Clinic said, shortly after he came to Cleveland. In 1999, Kyphon provided equipment to a handful of major medical centers, including the Clinic. Lieberman, a specialist in the surgical treatment of spinal disorders, oversaw the hospital's inaugural kyphoplasty work. The findings of the Lieberman-led 30-patient trial were the first kyphoplasty results by a hospital detailed in a medical journal.

Well before the publication of that study in July 2001, Lieberman's work helped Kyphon generate buzz about its new technology.

On the SpineUniverse Web site, Lieberman, Kyphon co-founder Reiley and three other doctors published a four-paragraph synopsis of their initial experiences with kyphoplasty involving 26 patients. 'These results support further use of kyphoplasty,' the March 2000 summary concluded.

Also in 2000, Kyphon posted data from Lieberman's Clinic procedures in bar-graph form on its Web site to show kyphoplasty's favorable results.

Kyphon's use of Lieberman's data and other information without FDA permission prompted the agency in October 2000 to issue a warning letter to Kyphon.
Kyphon gave Lieberman a seat on its scientific and clinical advisory board. And during the period he was conducting his first kyphoplasty trial at the Clinic, he had an offer of stock options from the company.

When Kyphon officials took their company public in May 2002, they disclosed in a filing with the Securities and Exchange Commission that they had offered stock options to the eight members of their advisory board. All took them except Dr. Joseph Lane, a New York orthopedic surgeon who teaches at the medical school affiliated with Cornell University.

As of December 2001, the company had reserved 948,000 options for consultants and other non-employees at a cost of $1 or less - some as low as 3.5 cents, records show. The company is not required to divulge how many were held for individual members of the advisory board.

Medical journals show that Lieberman and most of the other consultants conducted kyphoplasty research around the time they were offered stock options. Their research was frequently cited by Kyphon in promotional material aimed at other doctors and medical insurance providers. Lieberman and other consultants also lobbied for insurance coverage of kyphoplasty treatments.
Kyphon was straightforward in describing its motivation for offering stock to consultants, saying it provided 'additional incentive' and was designed to 'promote the success of the company's business,' SEC records show.

The article went on to document how Lieberman had failed to disclose his financial relationships with Kyphon when speaking in favor of kyphoplasty and Kyphon's products:

In the spring of 2005, Lieberman testified to the benefits of kyphoplasty at a Centers for Medicare and Medicaid Services committee hearing. He and all other participants were asked to disclose all past and present financial involvement — including stock and stock options — with device makers.

But Lieberman did not reveal his past stock holdings, limiting his disclosure to working as a consultant for Kyphon and receiving grant and research support from the company.

Later in the hearing, the committee vice chairwoman reminded participants to disclose all holdings and specifically asked Lieberman and other doctors if they wanted to note anything else. Lieberman said nothing about his past holdings.

The Clinic said Lieberman had sold all of his Kyphon stock by that time and that he was not asked to go into detail about his financial interests. Yet minutes from the hearing show that he was asked to disclose past and current stock holdings, and there is no record he made such a disclosure.

Physicians are expected to disclose to medical journals financial relationships with companies that are the subjects of their research. That standard has been in place about six years, according to medical ethicists, following a well-publicized patient death in a University of Pennsylvania clinical trial.

But Lieberman did not divulge any relationship with Kyphon when results of his first two kyphoplasty studies were published in 2001 and 2002. In a 2003 article detailing other research, Lieberman noted only that he was a consultant to Kyphon, which is how he has usually described the relationship in articles about kyphoplasty or in presentations at conferences. The Clinic last week acknowledged that Lieberman held stock in 2003.

He failed to identify his stock interests in Kyphon for specialized medical and general audiences, according to a Plain Dealer review of medical journals, other publications and publicly available conference programs.

Also,

Lieberman's actions are noteworthy for another reason: He is a member of the Clinic's conflict-of-interest committee, charged with overseeing the relationships the hospital's physician-researchers have with private industry.

The Plain Dealer reporter asked for a response from Lieberman. In a written statement, he said, "I strive to be transparent in my disclosures and believe that I have disclosed my interests within the guidelines and policies of the Cleveland Clinic," but would not be interviewed.

The article included some opinions about Lieberman's conflicts of interests:

Medical-ethics experts say Lieberman's relationship with Kyphon Inc., the Sunnyvale, Calif., kyphoplasty equipment company, is troublesome because the more favorable Lieberman's research and the more exposure given to kyphoplasty, the more valuable his Kyphon stock would have become.

'This is a classic tale of why you wind up with a lot of technologies that are marginally better or turn out not to be better at all than what you already had - because you rely on reports from innovators who have economic dogs in the fight,' said Dr. Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

Also,

Lieberman 'is out there pushing the procedure at the same time that he had an equity interest in the company that stands to gain from his pushing the procedure, said Dr. Jerome P. Kassirer, a former editor of the New England Journal of Medicine who has written extensively on the influence of business on medicine. 'He shouldn't be doing that.'

Indeed, not.

So here we go again, with another illustration of the pervasiveness of the web of conflicts of interest that now binds together commercial health care coroporations, academic medicine, hospitals, physicians, government agencies, not-for-profit organizations, etc., etc., etc. Furthermore, this case illustrates how people with considerable financial interests in particular companies and products may write and speak favorably about the companies and products as if they were only expressing their academic and/or professional opinions.

The frequent failure of physicians and scientists in government agencies, academic medicine, and other not-for-profit health care organizations to even minimally disclose their financial interests in companies that provide health care products or services ought to breed increasing skepticism about the sorts of biases that may afflict current health care discourse. Unfortunately, it may start to provoke outright cynicism.

WHAT CAN BE DONE?

At a minimum, we need clear policies requiring detailed public disclosure of conflicts of interest afffecting all health care professionals and decision makers, with strong negative incentives to those who fail to disclose.

I would go further and say we need to ban at least the most egregious conflicts.

Without such policies, it is becoming impossible to tell the difference between scholarly discussion, and professional opinion on one hand, and commercial marketing on the other.

One More Bites the Dust: Pediatrix Director Resigns After Stock Option Backdating Revealed

Yet another US publicly traded for-profit health care corporation had admitted a problem with backdated stock options, and consequently let go one of its top leaders. We had previously posted about the nationally known problems of this sort at UnitedHealth Group, which lead to the early retirement of the company's CEO. We had also posted about similar problems at Cyberonics, leading to the resignations of its Chairman and CEO, and chief financial officer.

Now it's Pediatrix's turn. Pediatrix describes itself as "the nation’s leading provider of maternal-fetal, newborn and pediatric physician services." Last week the Miami Herald reported:

Pediatrix Medical Group, South Florida's largest publicly traded healthcare company, said Wednesday its audit committee had found ''deficiencies'' in its granting of stock options to executives, including backdating, and the company may have to recognize an additional $28 million in compensation expense from 1995 through 2006.

The Sunrise-based company, which provides newborn and related physician services throughout the nation, also announced that Lawrence M. Mullen had resigned from the board.

In a prepared statement, the company said Mullen had served as chief financial officer, chief operating officer and vice president in charge of special projects from 1995 to his retirement in 2001. During that time, Mullen ``had a significant role in the administration of the company's stock option program and practices.''

Mullen had been a member of the audit committee but had recused himself from the option review.

So this is yet example of a health care organization whose leadership apparently put their personal financial gain ahead of the ethical management of the organization.

In the past, some people have dismissed cases of financial mismanagement like this as irrelevant to the current health care mess. I beg to differ. There are lots of ways this kind of leadership problem can make health care worse. Most obviously, it drains money that could have gone to actually providing health care. Next, managers who are spending their energy dreaming up schemes like this are not likely to be very good at managing actual health care issues. Then, the people who work for such managers are likely to sense what the managers' priorities are, and hence may be demoralized and unlikely to work as hard and as efficiently as they otherwise would.

Hence, we again call for transparent, accountable, ethical leadership of health care organizations. Such leadership would take us a long way to addressing the chronic problems of rising costs, declining access, stagnant quality, and dissatisfied professionals.

Sunderland Pleads Guilty to Criminal Conflict of Interest

We have posted frequently about allegations of conflicts of interest affecting top scientists and managers at the US National Institutes of Health (NIH). The most striking case has been that of Dr Pearson "Trey" Sunderland III, who formerly lead the Geriatric Psychiatry Branch of the National Institute of Mental Health (NIMH). Sunderland was just indicted for criminal conflict of interest, based on charges that the worked as a highly-paid consultant for Pfizer Inc while he did related research as a full-time NIMH employee. He also allegedly furnished Pfizer Inc with tissue samples he obtained during his NIHM work. (See most recent post here.)

Sunderland has just entered a guilty plea in this case. Per the Los Angeles Times, reported by David Willman:

A senior government scientist from the National Institutes of Health who took about $300,000 in unauthorized payments from a drug company pleaded guilty Friday to a federal charge that he committed a criminal conflict of interest.

The admission by Dr. P. Trey Sunderland III came after years of denials by his attorneys and six months after the scientist had asserted his constitutional right against self-incrimination to a congressional subcommittee.

The prosecution was the first of an NIH scientist under federal conflict-of-interest laws in 14 years.

Sunderland, 55, admitted that he failed to get required authorization for taking $285,000 in consulting fees and $15,000 in expense payments from the drug company Pfizer Inc. from 1998 to 2003. During the same period, he provided Pfizer with spinal-tap samples collected from hundreds of patients as part of a research collaboration approved by the NIH.

After the hearing Friday, U.S. Atty. Rod J. Rosenstein told reporters that Sunderland's actions were a breach of the public trust.

A plea agreement calls for Sunderland to pay the government the $300,000 he took from Pfizer, perform 400 hours of community service, and submit to two years of probation. [Judge] Motz set sentencing for Dec. 22.

Under the collaboration with Pfizer, Sunderland's staff provided Pfizer with spinal-tap samples they had collected from patients who had Alzheimer's disease or were at risk of developing it. Drug companies prize the material because it could contain genetic clues for finding a breakthrough treatment.

Sunderland at no point from 1998 to 2003 sought permission from his NIH bosses to take the personal payments from Pfizer, and he did not disclose the income on annual financial reports.

Also, as reported by The Scientist, the Geriatric Psychiatry Branch of the NIMH has been dismantled. But
despite Sunderland's plea, Pfizer Inc. denied any wrong-doing:

Sunderland 'received honoraria for consulting and educational activities that were reasonable and customary for an expert of his stature and expertise,' Pfizer spokesman Stephen F. Lederer told The Scientist in an email. 'We believe our actions complied with applicable laws and ethical standards. We are not aware of any allegation that we violated any law or regulation.'

In my humble opinion, the only way to start beating back the tide of conflicts of interest that has enveloped health care is to start assuring negative incentives that will outweigh the personal gain or business profits afforded by such conflicts. The conviction of Sunderland is a small, but important step in this regard.

On the other hand, it is unclear how Pfizer can maintain that its actions met "ethical standards" after a recipient of the payments the company made has been convicted of criminal conflict of interest for accepting these payments.

Conflicts of Interest on FDA Panel to Assess Drug-Eluting Stents

Bloomberg News reported (here via the Boston Globe) that a US Food and Drug Administration (FDA) panel which will re-assess the risks and benefits of drug-eluting stents (DES) for coronary artery disease will include six members with conflicts of interest. Per Bloomberg:

Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising US regulators whether to restrict the use of some products because of potentially lethal side effects.

The panel members, listed on an FDA website Nov. 22, will include Robert Harrington, who runs a Duke University research institute funded by stent makers J&J and Boston Scientific Corp.

To allow the doctors to participate in the review, the FDA is waiving rules that bar panelists from serving in matters affecting companies in which the experts have stock ownership or consulting contracts.

Agency critics, including Republican Senator Charles Grassley of Iowa, say only advisers without financial conflicts should be chosen.

Some members of Congress, including Grassley, and consumer groups such as Public Citizen in Washington have criticized the FDA in past cases for selecting panelists with financial ties to companies whose drugs or devices are under review.

Here we go again. If some members of this panel work part-time for manufacturers of DES, how critical of DES do we really expect them to be during the proceedings of the panel? If some members of this panel work part-time for manufacturers of DES, do we really expect them to ignore the interests of their employers? Finally, why does the FDA persist in putting on supposedly impartial panels meant to protect the interests of the public employees, albeit part-time, of companies whose interests will be affected by the deliberations of these panels?

This is just another case that illustrates how pervasive conflicts of interest have become in government and other health care organizations.

In my humble opinion, government regulatory agencies that are supposed to protect the health and safety of the public ought to listen to representatives of drug, biotechnology, and device manufacturers, but should not give employees of such companies decision making power within the agencies.

Note that this is the third post this week about conflicts of interest in US government agencies that are supposed to be protecting the health and safety of the public at large (see here for post about the NIH, and here for post about the CDC). Something is going seriously wrong here.

ADDENDUM (12/7/2006) In the media today (Reuters here, HealthDay here via the Washington Post) are reports that the FDA panel discussed above did not seem all too worried about the risks of drug eluting stents. Per the latter, "While the panel of 21 experts broadly dismissed the more serious risks, they split on saying the clotting risk was real in comparison with older, bare-metal stents. They agreed only that more study of the drug-coated devices is needed...." Is this so unexpected, given that almost a quarter of the panel has conflicts of interest involving the companies that manufacture such stents?

Also, note that further detail about these conflicts of interest appear in the full story run by Bloomberg News that was excerpted above by the Boston Globe, and in a story by the Newark Star-Ledger. Here is a list of the conflicted panel members from the latter:

The waivers went to Richard Page of the University of Washington, who has unrelated consulting agreements with a maker of a drug-coated stent; George Vetrovec of Virginia Commonwealth University, who has a consulting deal with a manufacturer of drug-eluting stents; and Clyde Yancy of the University of Texas Southwestern Medical Center, who has a consulting agreement with a company that makes a drug being tested for use with drug-eluting stents.

Waivers also were granted to Judah Weinberger of Columbia University, who owns stock in companies that manufacture drug-eluting stents; JoAnn Lindenfeld of the University of Colorado Health Sciences Center, a consultant with a stent manufacturer and a firm with a competing technology; and Duke University researcher Robert A. Harrington, who has consulting arrangements with several drug manufacturers with a stake in continued use of drug-eluting stents.

The Newark Star-Ledger quoted these comments from Merrill Goozner:

There are literally thousands of experts all over this country who are well-schooled in the details of this field.

But instead of reaching out to that community to get a totally unbiased look at this question, the FDA appointed a committee on which a substantial fraction have conflicts of interest directly with manufacturers of products being evaluated. It's almost impossible to have confidence in the outcomes of this kind of deliberation.

Precisely.

More Allegations of the Mis-Management at the CDC

The Atlanta Journal-Constitution last weekend published another report alleging management mis-steps at the US Centers for Disease Control (CDC). To summarize, the article reported that an unpaid advisor to the Director of the CDC recommended the agency contract with a consulting firm, Celerant Consulting, with which he appeared to have a personal relationship. Then, allegedly, CDC managers manipulated an existing contract that really did not cover the sort of consulting it wanted the firm to do to hire the firm, and after that contract ended, had the company keep working without a contract. The latter action could possibly be a violation of federal law.

To quote from the article (with some re-ordering):

The road that led to the CDC's hiring of Celerant began with an introduction made by Atlanta businessman Kent 'Oz' Nelson, who at the time was board chairman of the CDC Foundation, a nonprofit that supports the agency.

Nelson, former chairman and chief executive officer of United Parcel Service, became a key [CDC Director Julie] Gerberding adviser after she was named CDC director in July 2002. Nelson, among other things, worked to identify business consulting expertise to help Gerberding chart a new strategic vision and reorganization of the agency.

'I told her I'd be glad to help and began searching for someone. Coincidentally, around the same time, I got a phone call from Jim Down,' said Nelson in an article in the CDC Foundation's 2002-2003 annual report.

In an interview, Nelson said he knew and respected Down from Down's work years earlier as a UPS consultant. Down 'was extremely effective in strategic planning,' he said.

Nelson said he set up a meeting between Down and Gerberding. 'They hit it off very well,' he said. And Down agreed to provide his help and expertise for free, flying between Massachusetts and Atlanta nearly every week, Nelson said. The CDC reimbursed Down only for expenses, Nelson added.

In June 2003, while Down was serving as Gerberding's adviser, Celerant Consulting issued the press release announcing that Down had been appointed to the company's advisory board.
Around October 2003, CDC officials began discussing the need to overhaul the operations in its procurement and grants office. Down recommended Celerant for the job to CDC Chief Operating Officer Bill Gimson, said James Seligman, the CDC's chief information officer, in an interview Friday.

Gimson said Down did not mention any potential conflict of interest when he recommended Celerant. 'Jim's conversation, as a matter of fact, was extremely brief,' Gimson recalled Saturday. 'He said 'I would like to introduce you to a company I think would do great work for CDC.'' After the agency became interested, Gimson said, Down had no further involvement.

After examining Celerant and interviewing company officials, CDC decided to hire the firm, CDC officials said.

Rather than open up the consulting contract to competitive bidding, CDC executives went looking for an existing contract elsewhere in the federal government that would allow them to hire Celerant directly. Seligman, Kotch and Gimson said this is a common and accepted practice. 'Government agencies are encouraged to use government-wide contracts when they're available and appropriate,' said Seligman.

Seligman called contracting officials at the National Institutes of Health, who he said identified a pre-existing contract that would work. According to the NIH Web site, this particular contract, called ECS III, is for the purchase of computer hardware and software to satisfy your agency's desktop computing needs. CDC officials said it also allowed for the purchase of 'services.'
And, most important for achieving the agency's goal of hiring Celerant, one of the prime contractors had as a listed vendor Novell, the computer software giant, which at the time owned Celerant.

'This is a common abuse of IT hardware and software contracts,' said Christopher Yukins, associate professor of government contracts law at the George Washington University Law School in Washington. 'In this case you have an information technology — really a hardware/software contract — being used for consulting services that have little to do with information technology.'

Regardless, the NIH contract is the mechanism CDC used from about December 2003 to February 2004 to hire Celerant to do an initial assessment of how to fix the agency's procurement and grants office. The cost of this initial phase was about $580,000, Seligman said.

The CDC was pleased with Celerant's initial work and wanted the company to go ahead and implement its overhaul plan, at a cost of $10 million. Although the first contract had ended, Seligman said CDC let Celerant continue working and incurring costs while the agency sought NIH approval to again link to the IT contract.

Celerant worked without a contract in place for three months, Kotch said.

Yukins, the government contract law expert, said: 'The federal government takes work done without a contract very seriously. ... It's a violation of federal law, [and] technically speaking it is a criminal violation of law.' While prosecutions are rare, he said, it is a very serious matter.

In April 2004, an anonymous letter arrived at the U.S. Department of Health and Human Services, the parent agency of both the CDC and the NIH, alleging improprieties in the Celerant contracting process. Gimson said that when HHS notified him of the letter, he immediately sent a memo to HHS asking that it conduct an independent inquiry.

By July 2004, HHS officials were sufficiently concerned about the appropriateness of the contract that they issued a formal stop-work order. HHS officials would not grant interviews on the matter.

In September 2004, the CDC said HHS officials allowed the Celerant contract to be reinstated, but required the CDC to take over managing it. They also required the CDC to renegotiate the terms, which resulted in Celerant reducing its costs by $500,000, to $9.5 million. And the CDC set the effective date back to cover the February-May period when Celerant was working without a contract, the agency said.

A CDC public relations risk-management analysis obtained by The Atlanta Journal-Constitution identified several 'threats' to the agency, including 'significant procurement mistakes' and an 'inappropriately backdated' contract document.

The circumstances described in that risk analysis — which CDC officials now seek to discredit as merely 'conjecture' — raise questions about serious and potentially criminal violations of federal procurement law, according to government contract experts.

We have posted before about CDC management here. In that post, we noted that the agency was paying CDC managers, especially those within the Director's office, large bonuses in comparison to those paid to health care professionals at the agency. The rationale was the need for "management transformation" at the agency, and then to retain the top quality managers hired with that goal in mind.

However, the current case suggests that CDC managers at best seemed to be putting expediency and personal relationships ahead of careful business practices. Was this the sort of management transformation meant above? Now tell me again why it is so important we put managers and bureaucrats, rather than health care professionals, in charge of health care organizations?

NIH Leader Indicted for "Criminal Conflict of Interest" for his Relationship with Pfizer Inc.

We have posted a lot about the story of wide-spread conflicts of interest affecting top leaders at the US National Institutes of Health (NIH). After the NIH conflict of interest rules were relaxed in the mid-1990's, some top NIH managers received five- and six-figure consulting payments from pharmaceutical and biotechnology companies. Some failed to disclose these payments, even when writing journal articles favoring the products of the companies for which they worked. Since then, NIH Director Zerhouni made the organization's conflict of interest policies much more stringent, although not without opposition from some of his staff (see post here).

Most recently interest has focused on two cases. Dr Trey Sunderland, a leader within in the National Institute of Mental Health (NIMH), part of the US National Institutes of Health (NIH), provided tissue samples to Pfizer Inc while receiving consulting fees from the drug company. (See posts here, here, and here.)

So today, while newspapers were filled with stories of Pfizer's withdrawal of torcetrapib, a drug it had hyped as a new kind of treatment to prevent heart disease, a striking follow-up about Sunderland's relationship with Pfizer Inc. appeared with much less fanfare. Per the Associated Press (as available here from the Boston Globe), Dr Trey Sunderland has just been indicted for "criminal conflict of interest." The Globe reported (somewhat re-ordered):

In a rare federal prosecution, a leading government Alzheimer's researcher was charged Monday with a criminal conflict of interest for performing lucrative private drug company work that overlapped his official duties.

Prosecutors alleged Dr. Trey Sunderland of the National Institutes of Health received $285,000 in improper consulting fees and travel expenses from Pfizer, Inc., for work on early indicators of Alzheimer's at the same time he also oversaw similar NIH business with the drugmaker.
The private consulting 'directly related' to his government job, and Sunderland failed to obtain the proper approvals from his supervisors or disclose the work to NIH, according to papers filed in U.S. District Court in Baltimore.

The felony charge carries a maximum sentence of one year in prison and a $100,000 fine. Prosecutors filed the charge as a criminal information, instead of indictment, signaling the possibility of a plea deal.

The prosecution is believed to be the first such case against a federal scientist since the early 1990s.

Sunderland refused to testify before Congress last June, citing his Fifth Amendment right against self-incrimination.

Members of the House Energy and Commerce Committee which launched the probe called Monday for Sunderland's dismissal. Otherwise, Rep. Bart Stupak, D-Mich., said in a statement, 'We can only conclude that no one is being held accountable, the system is broken and the public trust has been violated.'

Rep. John Dingell, D-Mich., complained Sunderland had been kept on even after Department of Health and Human Services agencies found wrongdoing in their own internal investigations.

'Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?' he asked.

Ned Feder, a former NIH scientist now with the non-profit watchdog group Project on Government Oversight, said 'in this and similar cases NIH authorities have made it habit of covering up or minimizing wrongdoing. They are still hiding the details of other scientists' conflicts of interest over the past 10 years.'

Experts said the last prosecution of a senior NIH scientist was that of Prem Sarin, who was convicted in 1992 of embezzling a drug company payment to NIH that was intended to help with AIDS research.

Of course, an indictment does not prove criminal guilt. But the indictment of a formerly respected leader within the NIH for "criminal conflict of interest" certainly is a noteworthy step in the process of finally facing up to the conflicts that apparently afflicted a considerable number of the mid- and upper leadership of the NIH. These conflicts, in turn, are only a sub-set of the conflicts of interest that pervade other health care organizations, including medical schools and academic medical centers.

However, this case raises a further question. If Sunderland deserved indictment for taking money as a "consultant" from Pfizer Inc., and delivering to Pfizer samples he obtained while he nominally was working full-time for the NIH on issues related to his consulting assignment, what does Pfizer Inc., or the leaders there who decided to initiate the relationship with Sunderland, deserve?

Another Post-Modernist Attack on EBM: Because EBM is Not a "Vehicle" for Anyone's Political Program?

I make no secret of my support for evidence-based medicine (EBM). According to the Users’ Guides to the Medical Literature, at first the term described "an attitude of ‘enlightened scepticism’ toward the application of diagnostic, therapeutic, and prognostic technologies in ... day-to-day management of patients." Thus, "the goal is to be aware of the evidence on which one’s practice is based, the soundness of the evidence, and the strength of inference the evidence permits."[1] Another way to look at EBM is as a process, [2] e.g.:
1. translation of uncertainty to an answerable question;
2. systematic retrieval of best evidence available;
3. critical appraisal of evidence for validity, clinical relevance, and applicability;
4. application of evidence in practice; and
5. evaluation of performance.

EBM advocates understand that performing this process, however, is difficult and fraught with barriers and pitfalls. These include the shortage of coherent, consistent scientific evidence; difficulties in applying evidence to the care of individual patients; the need to develop new skills; limited time and resources; and the paucity of evidence that evidence-based medicine "works."[3] For discussions of how to cope with such difficulties and barriers, see these relevant articles.[4-6]

Yet EBM has produced negative reactions, some particularly intense, beyond what its well-described short-comings would seemingly inspire. These seem to be getting more frequent airings in the medical and health care literature, and in the media. See, for example, our previous posts on how EBM has been labelled "microfascist," both in a scholarly article (post here), and in an op-ed in US News and World Report (post here).

The latest example of such negative reactions is in an article recently published in Social Science Medicine.[7] This article by Goldenberg, entitled, "On Evidence and Evidence-Based Medicine: Lessons from the Philosophy of Science," like the one by Holmes et al,[8] took a post-modernist stance, with particular accent on feminism.

Like Holmes and colleagues, Goldenberg wrote in an opaque post-modernist style. She made the expected appeals to authority, but although these included the apparently obligatory bow to Foucault, she emphasized feminist authorities, such as Lorraine Code, Harraway, and Nelson. She quoted assertions by such luminaries as truth, without explanation or justification.

Like Holmes and colleagues, Goldenberg seemed to misunderstand EBM, and made arguments based on misunderstandings. For example, she equated EBM to logical postivism.

However, the apparent obviousness of EBM can and should be challenged on the grounds of how 'evidence' has been problematised in the philosophy of science. In this paper, I argue that evidence-based practices maintain an antiquated understanding of evidence as 'facts' about the world in the assumption that scientific beliefs stand or fall in light of the evidence. This understanding of evidence is explicitly positivist....

She then skewered logical positivism, citing how observation is theory-laden, and how theories are underdetermined. By thus discrediting logical positivism, she discredited EBM.

The formal methods promoted by EBM to replace so called 'traditional' medicine's over-reliance on intuition, habits, and unsystematic clinical experience appear to repeat the misplaced effort to separate science from values.

Note that most EBM proponents, of course, advocate the explicit incorporation of values into the EBM process, but they do distinguish values from science.

Goldenberg also wrote, citing Nelson as an authority,

The basic tenets of EBM, it seems, rest on the unquestioned authority of scientific evidence, a position that is now out of step with current post-postivistic thinking.

That might seem almost funny to an EBM proponent, given the amount of effort spent in the EBM process to rigorously critique evidence. EBM, in my humble opinion, is exactly the opposite of accepting "the unquestioned authority of scientific evidence."

Then, like Holmes and colleagues, Goldenberg accused EBM of badness. Although she did not label it "microfascism," her accusation was that EBM is harmful to women.

Feminist critiques of science are driven by a deep concern that the abstractions made in the names of scientific objectivity, generalisability, and predictability harm women. These tendencies appear to resurface in the practice of EBM.

And again,

Feminist insight reveals that the practices of EBM are marked by potential or actual gender bias, which has led at least one critic to argue that EBM is bad for women's health.

(And Goldenberg never questioned that critic's argument.)

Some of these accusations seem to be based on confusion between the messenger and the message. Goldenberg blamed EBM for insufficient representation of women in controlled clinical trials, "because evidence-based clinical decision-making, policy determinations, and the formulation of clinical guidelines rely upon existing clinical research, the movement reflects any gaps or biases that currently exist in medical research." Again, Goldenberg completely discounted how EBM has critiqued current clinical research for, among other things, not using patient populations whose results might widely generalize to the population at large.

Why are post-modernists taking such whacks at EBM lately?

Goldenberg may have provided a clue. She asserted,

A feminist philosophy of science is explicitly political, as science is recognised to be a vehicle for feminism's emancipatory programme.

I propose that one important reason that EBM may generate opposition is that EBM potentially challenges ideas, programs, and products in which people believe, or in which people have vested interests. If you really believe gizmo X works, or if you make a lot of money selling gizmo X, you may not be enthused about a rigorous review of the evidence that suggests that maybe gizmo X doesn't work so well.

In fact, EBM advocates suggest that EBM teaches people such new skills as "distinguishing evidence from propaganda (advertisement); probability from certainty; data from assertions; rational belief from superstition; and science from folklore."[2] Teaching people to distinguish evidence from propaganda and advertisement could offend the vested interests which increasingly dominate health care.

Goldenberg may have been particularly offended because EBM may not reliably support "a feminist philosophy of science [which] is explicitly political." Although Goldenberg asserted that "science is recognised to be a vehicle for feminism's emancipatory programme," EBM is not a vehicle for anyone's political program, no matter how well-intentioned.

Although some aspect of Goldenberg's political program may be worthwhile, for all I know, (which is little, since she did not explicitly describe this program), I think it is valuable to have a process like EBM which is hard for political advocates, as well as corporate executives and government bureaucrats, to manipulate.

Post-Script

Post-modernism has important influence in the humanities, and to some extent, the social sciences, in many US and other Western countries' academic institutions. Although post-modernists often claim that their work is supported by vast numbers of authorities and multiple weighty tomes, there have been a few well-written efforts to de-bunk the field. See in particular:
Hicks, SRC. Explaining Postmodernism: Skepticism and Socialism from Rousseau to Foucault. Tempe, AZ: Scholargy Publishing, 2004.
Koertge N. A House Built on Sand: Exposing Postmodernist Myths about Science. New York: Oxford University Press, 1998.
Sokal A, Bricmont J. Fashionable Nonsense: Postmodern Intellectuals' Abuse of Science. New York: Picador USA, 1998.
They did a much better job than I could do explaining why post-modernism is, as per Sokal's title, fashionable nonsense. It is too bad it has been slipping into medicine and health care, and now attacks EBM, which may be one of our few bulwarks against the economic vested interests that increasingly dominate medicine and health care.

References

1. Guyatt G, Rennie D, editors. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. Chicago: AMA Press, 2002. P. xiv.
2. Dawes M, Summerskill W, Glasziou P, Carabellotta A, Martin J, Hopayian K et al. Sicily statement on evidence-based pratice. BMC Medical Education 2005; 5: 1.
3. Straus SE, McAlister FA. Evidence-based medicine: a commentary on common criticisms. Can Med Assoc J 2000; 163: 837-841.
4. Haynes B, Haines A. Barriers and bridges to evidence based clinical practice. Brit Med J 1998; 17: 273-6.
5. Poses RM. Money and mission? - addressing the barriers to evidence-based medicine. J Gen Intern Med 1999; 14: 262-264.
6. Norman GR. Examining the assumptions of evidence-based medicine. J Eval Clin Practice 1999; 5: 139-147. 7. Goldenberg MJ. On evidence and evidence-based medicine: Lessons from the philosophy of science. Social Science & Medicine 2006; 62(11):2621-2632.
8. Holmes D, Murray SJ, Perron A, Rail G. Deconstructing the evidence-based discourse in health sciences: truth, power and fascism. Int J Evid Based Healthc 2006; 4: 180-186.

Report from the 12th International Anti-Corruption Conference: "Corrupting Health"

Last week, I was privileged to attend the 12th International Anti-Corruption Conference in Guatemala City, Guatemala. It was gratifying to be at a meeting of over 1200 people from over 100 countries who were all focussed on challenging corruption wherever it may be found. Some of the attendees had truly risked their lives to this end. One vivid example was the recipient of the 2006 Transparency International Integrity Award, Peruvian prosecutor Dr Ana Cecilia Magallanes Cortez, who fought corruption at the highest levels in here country's government, leading to the arrest of former president Alberto Fujimori.

A considerable amount of the meeting's program content seemed relevant to the issues we discuss on Health Care Renewal. I will report back on some particular issues in this regard in the near future.

I was also privileged to to participate in a workshop at the meeting on health care corruption. Our workshop leader, Roger Bate, has kindly posted a summary of what we were up to on TechCentralStation, entitled "Corrupting Health."

The summary rightly emphasized the substantial problem of government-focused corruption in developing countries, based on one definition of corruption used by Transparency International, "the use of public office to further private gains."

I must qualify one statement in the summary attributed to me, that "major corruption is estimated to be low in the US in the health sector." Given the definition of corruption above, and certainly relative to the role of governments in health care in developing countries, that statement is reasonable. However, I would point out that an alternative definition of corruption, ethical rather than legal, found in the Executive Summary of the 2006 Transparency International report on global health care corruption, is "the abuse of entrusted power for private gain." By that definition, corruption in US health care may not be so rare. See Health Care Renewal for examples.

Big employers plan electronic health records (and a manned Mars expedition as a warmup?)

The Wall St. Journal article on this is not yet available electronically, so the article below from the magazine "Red Herring: The Business of Technology" will have to do (perhaps not an inappropriate selection for the purposes of this Healthcare Renewal entry!)

Big employers plan electronic health records - and plan to deliver "a jolt to the US healthcare system", according to the WSJ. Will that "jolt", however, be the jolt that's expected?

Regarding the statement in the Red Herring article below that "... an employer-owned medical database for employees open's a Pandora's Box of privacy and ethical issues", as a former practitioner of occupational medicine in the medical department of a large, unionized municipal transit authority where these issues commonly occurred (e.g., over random drug testing and worker's compensation), I agree.

However, that's the least of the problems. A belief that expertise in computing hardware or in mass-merchandising enables such a venture is quite a quantum leap of faith.

Will the big-corporation approach to EMR work? I'd feel more confortable if the corporations had the complexities of healthcare and healthcare informatics within their core competencies.

See this link for some of the issues that won't disappear due to corporate will, as well as my previous post on Microsoft's clinical information technology venture here.

Also see the issues that are ongoing at Kaiser regarding their plans to be king of the EMR (see here and here , and for an alternate view see here). We report, you decide.

Intel, Wal-Mart Plan to become the Bill Gates of EMR

Companies attempt to heal a system that refuses to heal itself, but is Wal-Mart credible on healthcare?

November 29, 2006

By Cassimir Medford

Red Herring

A coalition of businesses including Intel and Wal-Mart will announce a plan that they believe will spur the development of a massive healthcare database in the United States , a digital Holy Grail that has been under debate for more than a decade.

According to Wednesday’s edition of The Wall Street Journal , Intel, which employs almost 100,000 people, and Wal-Mart, the largest private employer in the U.S. , plan to construct a database that will house the health records of their more than 1 million employees.

Hospitals, pharmacies, doctors, and insurers will have access to the database, which will be able to process the medical cost-sharing based on the health plans of the employees.

The healthcare industry has proven adept at adopting medical technology and a little less adept at adopting new drugs, but information technology has emerged painfully slowly in hundreds of systems that don’t communicate with each other.

For the most part, healthcare information systems have remained paper based, with all the errors involved in paper handoffs among doctors, nurses, hospitals, and pharmacies.

... an employer-owned medical database for employees opens a Pandora’s Box of privacy and ethical issues.

Plus the presence of Wal-Mart as one of the commercial leaders of the online patient’s records movement could present some drawbacks.

"Wal-Mart’s track record on the matter of healthcare benefits for employees has been less-than stellar so they are liable to get a lot of negative publicity for this database," said Charles King, principal analyst with PundIT Research.

... Can of Worms

There are also issues around discrimination from the employer, other potential employers, insurance companies, etc., based on an employee’s health records, which will be digitized, organized, and accessible in one place.

“People understand the benefits, but they are concerned about the Big Brother aspects that are troubling to a lot of people,” said Roger Kay, principal analyst of Wayland, Massachusetts-based Endpoint Technologies Associates.

... Under the Intel/Wal-Mart plan, employees will have ultimate control as to who accesses their records, according to the Journal , and they will have full ownership of those records [easier said than done - ed.]

The coalition hopes the healthcare industry will get on board, which could make the database the first or second phase in the general construction of a national patient health records database.

The UK has been trying this in their Connecting for Health government-sponsored national EMR project. They have not been having the best of luck at it:

Blair's barmy army
Times Online.uk

Critics say the government has blown £70 billion hiring management consultants to do the work of ministers and civil servants — badly. By Bryan Appleyard

Next month the National Audit Office is due to produce a report on government use of management consultants. “Don’t hold your breath,” says Neil Glass. Glass, writing as David Craig, is a whistleblower. His book, Plundering the Public Sector, paints a uniformly bleak picture of consultant greed and government incompetence. Since 1997, he says, consultants have cost the taxpayer £70 billion with either zero or negative returns. He doesn’t expect much from the NAO report because the audit manager, the key figure, of the study is Ron SirDeshpande.

Accenture, one of the giant consultancy firms, employed SirDeshpande for almost eight years before he came to the NAO. For Glass, this means he’s just one of the gang and he won’t dare rock the cosy consultancy boat. A spokesman at the NAO sighs: “I know who you’ve been talking to. Ron SirDeshpande works full time for the NAO and his voice is independent.”

Glass snorts.

On September 28, Accenture pulled out of its £1.9 billion contract with the NHS. Connecting for Health (CfH), a huge computer system, was cutting into Accenture’s profits and threatening its balance sheet with up to $450m in write-offs. Launched in 2002 as a project lasting two years and nine months and costing £2.3 billion, CfH has become a 10-year project with a probable cost of £12.4 billion.

Good luck, Wal Mart, Intel et al.

-- SS

The UMDNJ Mess: A Comment from the Front Lines

We have reported frequently about multiple kinds of misconduct by top leadership at the University of Medicine and Dentistry of New Jersey (UMDNJ). In our most recent post we noted how little had been heard from the long-suffering professionals and academics who have been laboring to fulfill UMDNJ's mission despite the turmoil at the top. In response, we got this comment from one such person on the front-lines, who will remain anonymous:

As a member of 'this long-suffering group,' I think you make a good point about talking to us. We've had a couple of town meetings with the governor, but that was before the latest round of scandals and very little about reorganization was discussed.

No one is talking about shutting down the parts of UMDNJ, just the superstructure. The best analogy I can think of is the Soviet Union. The component countries all still exist, they just don't have to worry about the Politburo anymore.

I doubt if you could find one faculty member at the Robert Wood Johnson Medical School who disagrees that UMDNJ should be restructured, and that restructuring should include emancipation of RWJMS from UMDNJ. If they shut down UMDNJ central administration completely, that would have the added benefit of saving money and electricity and relieving traffic congestion and parking around University Hospital in Newark.

We have often suggested that health care organizations require and deserve more representative, transparent, accountable and ethical governance.

In particular, despite being staffed by hundreds of well-trained and accomplished faculty members, it is remarkable how often the governance of medical schools and academic medical centers is top-down, and often in the hands of people with little experience or background in health care. This appears to have been true in the case of UMDNJ.

One wonders if CEOs would stop being "imperial," and would start listening to the talented people who work for them on the front lines, how many problems they would avoid, and how much better their organizations would become at fulfilling their missions?

The American Diabetes Association and Its Pharmaceutical Donors

The New York Times reported last week about potential institutional conflicts of interest affecting the American Diabetes Association. The Times' article's main focus was on the organization's ties to the food industry, especially to makers of highly caloric food:

SnackWell’s Sugar-Free Lemon Creme cookies have nearly as many calories as some sugar-rich cookies. Yet until recently the box featured an American Diabetes Association logo, advertising the cookie as a 'proud sponsor' of the charity’s efforts on behalf of the nation’s 21 million diabetics.

Foods like the Sugar-Freedom Eskimo Pie and Frosted Shredded Wheat have also sported the American Diabetes Association logo over the years. The companies paid the A.D.A. to be associated with a respected voice for healthful eating. The association wanted the money to finance its uphill battle against a widening epidemic of Type 2 diabetes, which is associated with obesity.

To its credit, the ADA has started to rethink its relationship with the food industry.

But in the last year the A.D.A. began rethinking how it raises money from companies, especially from those whose primary business is selling foods and beverages that are high in calories, even if they have created some sugar-free items.

The group has allowed some food company deals to expire and has turned down millions of dollars in new sponsorships.

However, although it received less attention in the article, what may be a more important issue is the ADA's relationships with pharmaceutical companies (quotes below somewhat re-ordered.)

Though they often present the most difficult choices, food companies represent a small segment of the A.D.A.’s corporate support. Pharmaceutical companies remain the largest corporate contributors, but the guidelines have not affected them as much because the A.D.A. has never allowed its logo to be put on specific medicines.

Others remain concerned about the A.D.A.’s relationships with pharmaceutical companies. Their presence is evident throughout the charity, from its annual convention, which is largely underwritten by drug makers, to its board meetings, where pharmaceutical executives have served on the volunteer committees that set policy.

The A.D.A. says its independence is evident because it has often acted against the interests of the pharmaceutical industry. Last month, for example, a panel it appointed to study how to treat people at heightened risk of developing diabetes decided against recommending the use of higher-priced brand-name drugs.

But critics say the drug industry’s influence can be seen in the A.D.A.’s emphasis on the treatment of diabetics, which often involves drug therapy, over efforts to persuade people to change the way they live so that the disease can be prevented in the first place.

Dr. Peter Lurie, deputy director of the Health Research Group of Public Citizen, the government watchdog group, said the influence of pharmaceutical money can be very subtle.

'The question is what happens in the close calls,' he said. 'If you are at more cocktail parties, if you have more mugs from the company in your kitchen, you are just going to be more receptive.'

A.D.A. officials cited an event from several years ago to illustrate their resistance to such influence. An A.D.A. panel found that antipsychotic drugs could help fuel diabetes. The announcement angered a drug manufacturer, Eli Lilly and Company, a longstanding A.D.A. benefactor that stood to lose hundreds of millions of dollars in lawsuits.

Some A.D.A. officials said they believed the company became so angry it sought to have Dr. Kahn fired, a charge the company denies.

Either way, nothing happened. Dr. Kahn, the association’s chief scientific officer, kept his job.

'Show me one instance where money has caused us to do something that is wrong,' Dr. Kahn said in an interview. 'You can’t.'

One starts to wonder whether there is any large US health care non-profit corporation that does not receive a significant amount of funding from the for-proft health care sector.

It may be very hard to prove such relationships have caused not-for-profit organizations like the ADA to do "something wrong," especially if one demands a scientific level of proof of causation.

On the other hand, a not-for-profit that gets a large amount of money from, say, the pharmaceutical industry might be hesitant to be critical of the industry or its products, or prone to give the industry the benefit of a doubt.

But even such relatively subtle biases could put the industrial benefactor's interests ahead of the not-for-profit organization's own mission.

Large, stable funding streams from commercial firms may be tempting, but not-for-profit leaders must ask themselves if they are worth the doubts they ought to raise.