A Truly Appalling Lawsuit Against Duke University

Most everyone is aware of the Duke lacrosse team scandal, the debacle about alleged rape by Duke lacrosse team students that led to the resignation of prosecutor Nifong for prosecutorial misconduct, exoneration of the accused, an expose of the radical agendas of a subset of Duke's faculty, and a great deal of national publicity, or, I should say, notoriety.

Now, in Dec. 2007 several of the team members have filed a civil suit. The lawsuit filing documents are downloadable from these links (PDF files):

Part 1 (100 kb PDF)
Part 2 (1.3 Mb PDF)

I recommend downloading and perusing these in their entirely. Stunning - and frightening.

Using Adobe Acrobat, a search in them upon the term "medical" is of great concern. Named in the suit as defendants are Duke University Health Systems, a private diagnostic clinic contracted to Duke, a number of physicians and RN's, and unversity officials overseeing medical affairs.

What caught my attention were:

• A massive conspiracy to deprive three young men of their rights under the U.S. Constitution, of Stalin-police state proportions
• Sections on production of falsified medical records to support fabrications regarding sexual assault examinations
• The naming of a number of Duke medical center and medical center-associated officials including the Chancellor for Health Affairs (a physician Victor Dzau MD) as direct participants by commission and/or omission (e.g., indifference to, and failure to act against obvious impropriety)
• The collusion or tepid reactions of the most senior Duke officials right up to the Chairman of the Board of Trustees.

Overall, this story would make for the most stunning of movies of Serpico proportions - and probably will be, and should be.

If the allegations are even partially true, we have the most candid expose of the severe state of moral decay that afflicts our educational system (a system that produces our leaders of other organizations), our healthcare system, our justice system, and our culture.

More on the Duke situation can be found at this extensive, well-written fellow blogspot site, put together by one non-Duke professor named KC Johnson, Durham-in-Wonderland.

How I became aware of this is a story unto itself.

I noted the following passage in a polemical November 2007 article most ironically entitled Academic Freedom: The 'Danger' of Critical Thinking", International Studies Perspectives 8 (4), 396–400, doi:10.1111/j.1528-3585.2007.00306.x by Duke Professor of Asian and African Languages and Literature Miriam Cooke (fulltext here):

In this time of war that allows some people to lie and cheat, it is taboo for others to think critically ... It is dangerous even "to speculate about the relation between this war (in Iraq) and the geopolitical interests of Israel." These are the words of Paul Gilroy, who, at the time of speaking, was chair of African-American studies at Yale. Enraged, his colleague Scott Siluerstein compared him with Hitler and claimed that his words "illustrated the moral psychosis and perhaps psychological sadism that appears to have infected leftist academia." (Younge 2006).

This discovery led me to a literature search that led me to the Duke lawsuit documents. Cooke is profiled here.

Cooke actually misquotes a misquote by writer Gary Younge in the British newspaper The Guardian in an article "Silence in Class", April 4, 2006. In turn, Younge had misquoted an editorial authored by me that appeared in the Wall Street Journal on April 17, 2003 (see this link for my original.)

To be more precise, I should say that Younge used the "art of political war" rhetorical ploy utilized to discredit anyone who even writes about history's worst figures and any favored academic/politican/etc. in the same essay. As an act of obfuscation and diversion in the interests of ideological/political warfare, the ploy is to say the author is comparing the subject to history's worst figures, or even equating them. Cooke then parroted Younge's rhetoric.

Why the diversion and obfuscation? To obscure that I was actually pointing out that dangerous ideas -- especially crackpot conspiratorial ideas held by numerous very notorious historical figures dating back centuries -- have dangerous consequences. I was also commenting on the proven bigotry, cruelty, crassness, and insensitivity of statements made by deGenova, Baraka, Gilroy and others towards Israel, Holocaust victims and their families. (If you want a flavor of what many radical academics write, say, or think of as brilliant work, see here and here as examples.)

This ploy and lexical, semantic, contextual, and other games often seem the limit of the capability for debate of far too many of today's academics and mainstream media writers. (Where they learn these tactics, I do not know, but perhaps there is some sort of training fellowship.)

Duke Prof. Cooke didn't bother to contact me, a fellow academic, nor apparently do a simple google search or utilize the considerable informatics resources of her own university's library to find my original Wall St. Journal letter and my online response to Younge, on AOL at the time and now here. (Another possibility is that she did find them and ignored them, of course.) Cooke simply parroted Younge plus for literary effect invented my being "enraged" at my "colleague" (in fact, I rolled my eyes at Gilroy's statements, as one does towards the drivel coming from the Ivy League these days, and a simple fact check would have shown that I was not Gilroy's "colleague" and that our times at Yale did not intersect).

In summary, academic research for this tenured professor and Oxford graduate consists of parroting secondary sources such as The Guardian as fact, inventing events and relationships that did not exist, and not bothering to check primary sources either directly or indirectly, a fundamental tenet of reputable academic research. Or perhaps Cooke chose to ignore primary sources, a rather shoddy and irreputable approach to scholarly research. To Cooke, "critical thinking" apparently means "semantic legerdemain and reckless criticism of everything she does not agree with."

I subscribe to a different definition, consistent with the teachings of my early mentor Victor P Satinsky, inventor of the Satinsky clamp and many other cardiothoracic surgery tools and techniques used to this day. Dr. Satinsky ran ran rigorous programs emphasizing critical thinking, responsibility, and clear, direct language in the interests of patient care:

Critical thinking means correct thinking in the pursuit of relevant and reliable knowledge about the world. Another way to describe it is reasonable, reflective, responsible, and skillful thinking that is focused on deciding what to believe or do. A person who thinks critically can ask appropriate questions, gather relevant information, efficiently and creatively sort through this information, reason logically from this information, and come to reliable and trustworthy conclusions about the world that enable one to live and act successfully in it.

(It's not a simple matter of incompetence. "Quackademics" who do not believe in reason and logic - the tools of the "oppressors" - are largely incapable of true critical thinking. Hysterical rants, semantic trickery, obfuscation they can do. Distortions and mistruths are no problem for them, since in their minds the means justifies the ideological ends. Put plainly, they are deceptive liars. But they are not incompetent. In the Art of Political War, they are actually quite competent. It does, however, scare the daylights out of such academics when people who do think rationally have "got their number" on that particular skill. Thanks to advances in information and communication technologies, an increasing number of ordinary people are "getting their number." Of that they are truly terrified. But I digress.)

Not surprisingly, I discovered that Cooke was a member of the "Group of 88", a group of Duke professors who apparently gave the accused students a behind-closed-doors fair trial (of course, defendants' presence not required), then lined them up and had them figuratively shot with a well-publicized statement implying their guilt. From the Inside Higher Ed article linked above:

... The 88 signatories affirmed that they were “listening” to a select group of students troubled by sexism and racism at Duke. Yet 8 of the 11 quotes supplied from students to whom these professors had been talking, 8 contained no attribution — of any sort, even to the extent of claiming to come from anonymous Duke students. Nonetheless, according to the faculty members, “The disaster didn’t begin on March 13th and won’t end with what the police say or the court decides.” It’s hard to imagine that college professors could openly dismiss how the ultimate legal judgment would shape this case’s legacy. Such sentiments perhaps explain why no member of the Duke Law School faculty signed the letter.

I contacted Cooke, pointing out her errors and providing rather sarcastic commentary on how I was part of the Great Walt and Mearsheimer Cabal against academic freedom (a metaphor for another rather tenuous and tendentious piece of 'research' from yet another Ivy, Harvard). I have not received any reply. This is typical of academic tyrants, who are cowards when confronted outside of their power base. I contacted by email and phone the office of Duke President Richard H. Brodhead inquiring if Brodhead believed citing secondary sources constituted good research practice. He also has not replied.

Finally, I wonder if current Duke president Brodhead, who was an official at Yale until 2004 and implicated in this Duke lawsuit for sins of omission and commission, was involved in events covered in the previous post about an ongoing Federal investigation of Yale research grant accounting ("Lux et Veritas, or Trust But Verify? Yale discovers eDiscovery"). An interesting Powerpoint presentation on that matter is here (PPS file).

I think a comment made on the Duke-in-Wonderland site is particularly apropos:

"Another development on the local Duke scene is the “raised consciousness” of sensible alumni and institutional friends ... Any intelligent Duke alumnus of whatever age should now realize that he or she probably has more sensible and constructive ideas that many prominent Duke faculty."

This Duke disgrace is perhaps an epitaph for today's tenured, $100,000+ annually, pot-smoking, "oppressed" 1960's misfit-dominated academia.

-- SS

Addendum: there is much wisdom in this posting by KC Johnson regarding intellectual decay in academia. Many of the points raised also apply to the matters discussed on this blog. That academia sets the tone through its influence on students suggests that one path to "healthcare renewal" is via "academic renewal."

"Why I Sent It Is a Mystery" - More About Avandia, Conflicts of Interest, and Confused Thinking

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, 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.)

So it is ironic that the latest Avandia controversy is about the premature release of a manuscript submitted for publication.

Recall how the story began, with the publication in the New England Journal of Medicine by Nissen and Wolski of a meta-analysis focused on cardiac adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) (see post here). The main achievement of the Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone completed to date. Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug, most of which have not been published to date. They did eventually appear on a web-site run by GSK. However, this web-site was relatively obscure, and it was not created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link here and our post here). Nissen and Wolski found it, compiled the results of trials on Avandia, and combined their results with those of the few published trials in their meta-analysis.

Now it turns out one of the NEJM peer reviewers of the Nissen and Wolski manuscript leaked it to GSK well before the manuscript was published. From the News section of Nature,

17 days earlier [before the article was published], the reviewer, diabetes researcher Steven Haffner of the University of Texas Health Science Center at San Antonio, had faxed his copy of the article to Alexander Cobitz, a GSK employee whom Haffner knew from working on an earlier clinical trial of the drug.

This was a serious breach of the reviewers' code of conduct. Having reviewed many articles for many medical journals, (but not the NEJM), I can say with conviction that reviewers are forbidden from releasing unpublished manuscripts to anyone, with only one major exception. Reviewers can seek reviewing help from a colleague, as long as this is disclosed to the journal, and the colleague does not further release the manuscript.

As pointed out by an article by Stephanie Saul in the New York Times,

Under The New England Journal’s rules, reviewers are prohibited from disclosing an article’s contents before publication, as a way of protecting the exclusivity of the journal’s material and protecting the intellectual property of scientists who submit articles.

Besides violating The New England Journal’s rules, disclosing a pending article would also be considered a breach of professional ethics, according to Dr. Jerry Avorn, a professor of medicine at Harvard Medical School. Dr. Avorn said that he was not familiar with the specific allegations against Dr. Haffner.

So why did Dr Haffner do it? His explanation of why he sent the manuscript was at best incoherent.

'Why I sent it is a mystery,' Haffner told Nature . 'I don't really understand it. I wasn't feeling well. It was bad judgement.' Haffner says that Cobitz did not ask to see the draft and was 'probably a bystander'.

According to a report in theHeart.org, a GSK spokesperson rationalized Haffner's conduct thus,

Haffner, who consulted for GSK on Avandia, had concerns and questions regarding the methodology of the analysis and sent the article to GSK for advice from company statisticians.

This begs the question of why he did not simply note in his review his lack of expertise on the relevant statistical issues, or seek help from a statistician at the University of Texas.

So perhaps we should seek other explanations. Dr Haffner, it turned out, had a number of financial ties to GSK. As reported in Nature.

Haffner had earlier served on the steering committee of a GSK-sponsored clinical trial of Avandia. He says that he has given many talks for the company, although he declined to say how much he had earned from them. 'I've got a considerable amount of money. I didn't do it to raise my income or anything like that,' he says.

Furthermore, in the NY Times article,

Dr. Haffner, who had been involved in a clinical study that found Avandia worked better at controlling blood sugar than two other treatments, was quoted last year in the online medical publication TheHeart.org criticizing the publication of Dr. Nissen’s study and of editorials that supported it in two other journals.

'The three major medical journals are becoming more like British tabloid newspapers. All they lack is a bare-chested woman on Page 3,' Dr. Haffner was quoted as saying.

In fact, Dr Haffner was one of the co-investigators for the ADOPT study, which compared rosiglitazone to metformin or glyburide, and was sponsored by GSK. [Kahn SE, Haffner SM, Heise MA et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-43. See link here.] In that article, Haffner disclosed,

Dr. Haffner reports receiving consulting fees from AstraZeneca and Takeda; consulting fees and grant support from Novartis and Pfizer; grant support and consulting and lecture fees from GlaxoSmithKline; consulting and lecture fees from Merck; and lecture fees from Sanofi-Aventis.

Furthermore, an article in the Philadelphia Inquirer noted,

Haffner is a national expert in diabetes. His university Web site calls him 'one of the highest-funded investigators, in terms of [National Institutes of Health] funding, in Health Science Center history.'

And we know that in this age of "greed is good" as the reigning philosophy in medical schools and academic medical centers, the biggest "tax-payers" like Haffner can do no wrong in the eyes of the administrators of these institutions.

So the Avandia story gets more complex, involving more people with more conflicts of interest, and not only suppression of research, but the breach of confidentiality of an unpublished manuscript submitted for publication.

Dr Haffner's nearly nonsensical explanation of why we went running to his fax machine to send the confidential manuscript to his part-time GSK employers is another reminder of the confused reasoning often displayed by people with conflicts of interest, even full professors of medicine who are supposed to be national authorities. As noted before, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." Apparently becoming a consultant for a pharmaceutical company makes one susceptible to faxing confidential manuscripts in a fugue state, something like the sleep-driving pheonomenon reportedly caused by sleep medications like Ambien.

This latest development in the Avandia case is yet another argument that physicians should not only not accept pens, coffee mugs, and free pizzas from companies trying to sell their medical and health care products and services, but that academic physicians should shun all financial ties to these companies. (A physician who wants to work for a pharmaceutical, biotechnology, or device company should do so full-time, or not at all, in my humble opinion.)

Otherwise, prepare to appear on the national news blinking like a deer in the headlights, saying "Why I did it is a mystery."

ADDENDUM (31 January, 2008) - See also this post on the Clinical Psychology and Psychiatry Blog.

No quick fixes in medicine - whoda thunk it?

To many non-medical people, it really appears they believe the "fixes" to medicine are simple, deterministic (i.e., computerization as a panacea), and that many of the problems are generally a result of bad behavior by clinicians. The significant brouhaha about handwashing is such an issue:

Cleaner but not safer hands?
A study found that even when use of a gel rose at a hospital, infection rates were unchanged.

By Timberly Ross , Associated Press, Wed, Jan. 30, 2008

OMAHA, Neb. - Doctors and nurses on the go often skip soap and water in favor of an alcohol-based hand gel, thinking the quick-acting goo will kill bacteria on their hands and curb the spread of infection. Turns out that's not enough.

Workers nearly doubled their use of the alcohol-based gel at a hospital here. Their hands were cleaner - but the rate of patient infections was virtually unchanged.

The doctor who studied the problem pointed to many villains: rings and fingernails too long and hard to clean, poor handling of catheters, unsanitized treatment areas.

"There are many factors that influence the development of hospital-acquired infections," said Mark Rupp, an infectious-disease specialist at the University of Nebraska Medical Center who led the study at the adjoining Nebraska Medical Center. "It would be naive to think that a single, simple intervention would fix this problem."

His research appears in the January issue of Infection Control and Hospital Epidemiology.

The spread of infection-causing germs in hospitals is a huge problem, accounting for an estimated 1.7 million infections and nearly 100,000 deaths each year, according to the Centers for Disease Control and Prevention. These include drug-resistant staph,urinary-tract infections, and ventilator-associated pneumonia.

Mike Bell, who deals with infection control at the U.S. Ceners for Disease Control and Prevention, said that while he did not agree that hand gels did little to reduce infection, Rupp was right to say they were just one part of the solution.

"If they don't do everything else right, having clean hands is not enough," he said.

Unfortunately, "doing everything else right" calls for keeping a hospital, medical equipment, etc. scrupulously clean. That requires significant resources - meaning, chemicals, people, and labor. The current precarious financial condition of many hospitals would seem to preclude that. The financial problems arise from a number of actors including mismanagement, too much management, and declining reimbursement from payors.

It would seem current leadership of healthcare organizations by cost-cutting, profit-motivated management, as well as the for-profit desires for payers, cannot compete with several billion years of microbial evolution.

-- SS

"Bungled," Not "Brilliant" Results of UnitedHealth Takeover of Pacificare

We had posted often (see these posts here, here, and here from 2006 with links backward) about the hugely lavish compensation afforded to the Dr William McGuire, former CEO of UnitedHealth Group, one of the largest US insurers/ managed care organizations, and how this remuneration stood in stark contrast to the stated mission of UnitedHealth Group:

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

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

Once again, it seems that in retrospect, Dr McGuire's conduct stood in sharp contrast to the lofty sentiments expressed in UnitedHealth's mission statement. It also stood in stark contrast to the lavish praise once heaped upon him. A 2006 Pulitzer Prize winning article in the Wall Street Journal quoted UnitedHealth director and Dean of the Columbia University School of Nursing Mary Mundinger,

We're so lucky to have Bill. He's brilliant.

This week, there appeared in the press another reminder how brilliant the leadership of UnitedHealth wasn't. Lisa Girion reported in the Los Angeles Times,

California regulators are expected to announce today that they are seeking as much as $1.33 billion in penalties from Cypress-based PacifiCare as a result of widespread problems stemming from its takeover two years ago by healthcare giant UnitedHealth Group Inc.

In an investigation prompted by widespread complaints, the state Department of Insurance uncovered 133,000 alleged violations of state laws and regulations regarding payments for medical care. Each violation carries a maximum penalty of $10,000 for a possible total of $1.33 billion.

Separately, the state Department of Managed Health Care alleged that 30% of the medical claims it reviewed were improperly denied. That agency is seeking an additional $3.5 million in fines.

'These were very serious violations,' said Cindy Ehnes, executive director of the Department of Managed Health Care. 'The most fundamental promise of insurance is that they will pay when you are sick, and they will pay those physicians and hospitals in a fair manner.'

Insurance Commissioner Steve Poizner expressed frustration at efforts to get the company to make changes.

'After years of broken promises to California regulators, it became crystal clear that PacifiCare simply could not or would not fix the meltdown in its claims-paying process,' he said. 'We're going to put an end to that. If PacifiCare can't understand the ABCs of basic claims payment, maybe it will understand the dollars and cents of regulatory action.'

The problems stem from the $9.2-billion purchase of PacifiCare by Minneapolis-based UnitedHealth in January 2006. The deal added more than 3 million Californians to UnitedHealth, which now has about 27 million enrollees nationwide.

The company's regional executives acknowledged that the merger was bungled in many ways. In a meeting with Times reporters and editors Monday, David Hansen, UnitedHealth's regional chief executive, apologized for the problems that the transition caused physicians, hospitals and patients.

Brilliant, eh? In response to this latest debacle, California Insurance Commissioner Steve Poizner said (per another article by Lisa Girion in the LA Times),

Their [the insurance companies' and managed care organizations'] business is to colelct preimiums and pay claims for legitimate healthcare expenses. We're talking about basic issues here. This is fundamental to their business.

So if they do not adequately take care of their members and pay claims fairly, Poizner said he will

come down on them like a ton of bricks

It's nice to see regulators in one state trying to make sure that health care insurers and managed care companies live up to their basic obligations to those from whom they take money. It would be nice to see other state regulators do the same, and then to see state and federal regulators who are supposed to keep the economic playing fields level consider whether other health care organizations are living up to their basic obligations.

Clearly, this story is also a reminder that people would get better, cheaper, more accessible health care if health care organizations were run by leaders who put the health of those they supposedly serve ahead of their urges to become filthy rich. The current perverse incentive structure in the US (and elsewhere), though, seems to reward leaders for something else, like the faux brilliance of the previous UnitedHealth CEO.

Spinal Fusion and COI

Today's (20 January 2008) New York Times has a useful piece about the Conflict of Interest between device companies and surgeons.
Seems that, in the clinically still-murky field of spinal surgery, an awful lot of doctors are implanting devices made by companies in whom their financial interests, now disclosed, were there from the get-go.
What's most disturbing about this saga, though, is the notion that "in the case of the Prodisc clinical trial, as with any clinical research, the doctors were supposed to be acting not as advocates for the product but as objective scientists studying whether the disk was safe and effective."
How is it possible to do both? What are they thinking?
Oh, that's right. They're thinking, I can do well and do good.
But Richard Deyo, MD, of Oregon Health Sciences University, quoted in the Times piece, perhaps says it best:
“The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing....” More people are interested in getting on the gravy train than on stopping the gravy train.”
Guess the Pogo Effect is now the norm.

More Managed Care Management Mumbo Jumbo

A number of news items about managed care organizations/ health insurers published last week make for an interesting juxtaposition.

Innovative Physician Reimbursement?

First were articles about managed care proposals for innovative physician reimbursement. First, from the Boston Globe, an article about a proposal to resurrect capitation.

Massachusetts' dominant health insurer is proposing to overhaul the way it pays doctors and hospitals, in what company officials said is an attempt to slow runaway healthcare costs and improve the quality of care.

Blue Cross and Blue Shield of Massachusetts wants to stop paying doctors and hospitals for each patient visit or treatment, a common arrangement that most experts agree has led to unnecessary, inefficient, and fragmented care that is sometimes harmful to patients.

Instead, they want to pay doctors and hospitals a flat sum per patient each year, adjusted for age and sickness, plus a significant bonus if the providers improve care, Blue Cross officials said. In most cases, the payment would cover all services from primary care doctors, specialists, counselors, and hospitals - forcing them to work together closely.

Hmmm, that sounds like "capitation," paying physicians or hospitals fixed sums per patient covered. That idea died out in the 1990s. Its main drawback was that it effectively transferred risk from the insurer to the physician or hospital. The latter were at risk for bankrupting losses if their patient populations turned out to be unusually expensive. The risk was greatest, per the laws of probability and statistics, for the doctors and hospitals with the smallest patient populations. Thus the problem with capitation is that it provides a perverse incentive to avoid sick or complicated patients. This suggests it will not improve quality or access.

Would this new version of capitation address this problem? Not obviously. The quote above suggests some adjustment for "sickness," but how whether that would be adequate to avoid perverse incentives is unclear. Also,

The Blue Cross plan has some similarities to the 'capitation' payment system behind those problems, which was widely used in the 1990s but was vehemently rejected by many doctors and patients. Blue Cross says its plan includes safeguards to avoid the undertreatment, underpayment, and strict controls on patient choices that doomed capitation.

'We have no interest in returning to the heyday of managed care or denying care,' [executive vice president for healthcare services at Blue Cross Andrew] Dreyfus said. He said several mechanisms would prevent patients from being denied appropriate care, including public scrutiny of doctors' performance and Blue Cross's commitment to cut off any caregiver providing substandard service.

That isn't very reassuring. The problem is not only that doctors might deny patients adequate care, but that doctors may avoid having sick or complex patients on their panels.

The next brilliant idea was described by the Wall Street Journal.

Health plans are drawing scrutiny for offering financial incentives to entice doctors to prescribe cheaper generic medicines, including paying doctors $100 each time they switch a patient from a brand-name drug.

The incentive program that has drawn the most scrutiny is one initiated last year by Blue Care Network, a health-maintenance organization owned by Blue Cross Blue Shield of Michigan. Under the three-month program, called Blue Reward$, primary-care physicians were asked to consider switching patients from a brand-name drug and received $100 for each plan member who filled a generic cholesterol-lowering statin prescription. To assist doctors, the HMO mailed them a list of Blue Care Network patients who were taking Lipitor and Lescol, two brand-name statins.

This seems to come from the two wrongs make a right school of thought. We, and many others have criticized pharmaceutical, biotechnology, and device companies for gifts and payments to doctors that may influence their decision making in ways that do not necessarily help their patients. Now managed care organizations and health insurers are doing the same, this time to directly influence physicians to prescribe more generic drugs. Of course, there are many patients now taking expensive brand-name drugs who could do just as well taking generics. However, there are many other patients for whom the brand-name drugs may provide the best benefit/ harm ratio. Paying doctors to prescribe generics, regardless of whether his or her patients may experience benefit or harm from this decision, is also a perverse incentive likely to lead to bad decisions harmful for some patients.

Such concerns were raised in the WSJ article.

But the more aggressive approaches, such as cash rewards for each patient switched from a given list of drugs, are coming under fire for injecting financial incentives into what some patient advocates and legislators say should be a purely medical decision. Medical societies are also concerned that such rewards may put doctors in the ethically questionable position of taking a payment that patients know nothing about.
'I'm all for saving health-care dollars, but my concern is if there's a direct financial incentive for a physician to prescribe a certain generic drug, we cannot really trust that decision,' says Peter Koutoujian, house chairman of the Massachusetts legislature's Joint Committee on Public Health. He introduced a bill in the committee last month to ban drug-switching incentive payments to doctors.

It's interesting that both these innovations hinged on physicians' reimbursement, yet did not clearly address what seems to be the biggest distortion of such reimbursement, the imbalance favoring procedures over cognitive care, propagated by the Medicare reimbursement system influenced by the secretive RBRVS Update Committee (RUC). (See related posts here, here, and here.) Also, these innovations represent yet another example of managed care organizations/ health insurers avoiding addressing the prices of drugs and devices directly.

The Corporate Culture of Managed Care

Hints about why managed care organizations' and health insurers' leadership may favor perverse incentives and avoid confronting the more difficult problems comes from some more of last week's articles.

First, again in the Boston Globe, was an article about the leadership of the same Blue Cross and Blue Shield of Massachusetts that advocated a new version of capitation above.

Attorney General Martha Coakley is investigating the $16.4 million payment Blue Cross and Blue Shield of Massachusetts made to William C. Van Faasen, the insurer's former chairman and chief executive, who retired Jan. 1, according to a Blue Cross-Blue Shield director and others with direct knowledge of the probe.
more stories like this

Coakley is also examining the new management structure at Blue Cross-Blue Shield under which Cleve L. Killingsworth holds the positions of chairman and chief executive.

The size of the payment is considered extraordinary by some because as a nonprofit, Blue Cross-Blue Shield is expected to use surpluses to support its healthcare mission.
Commenting on public charities in general, Harry Pierre, a spokesman for the attorney general, said, 'A public charity must use all of its funds to advance the charitable purpose for which it was established.'

Van Faasen earned nearly $3 million in salary and bonus in 2006, according to a recent filing made with Coakley's office, which oversees the state's charities and nonprofits. That included $500,000 in base pay and $2.46 million in bonus based on results, according to the company's filing.

Some healthcare industry officials said they are troubled that Blue Cross-Blue Shield chose to let one person hold the titles of chief executive and chairman.

'This is a terrible design and it's just a bad idea,' said Nancy M. Kane, professor of management at the Harvard School of Public Health. 'It makes accountability of the organization to the community, represented by the board, a farce.'

Linda Crompton, chief executive of BoardSource, a Washington, D.C., organization that advises nonprofits on corporate governance, said the insurer's structure 'raises all kinds of issues about independence.'

'Having one person fill both positions is a very poor practice, and it's something we counsel against,' said Crompton.

A not-for-profit health care insurer which sees fit to make its executives rich, and set up a governance structure which renders accountability a "farce" is probably not going to be terribly hostile to perverse incentives for physicians.

In addition, last week featured several more stories about the corporate culture of managed care organizations/ health insurers.

From the AP, via the Indianapolis Star, was this story about the formerly "most admired executive" of WellPoint, a for-profit insurance company which runs multiple Blue Cross plans. Its California operation has under fire for allegations that it cancelled coverage of individuals after they developed expensive medical problems (see post here). The executive clearly seemed to have too much money to burn.

David Colby was one of corporate America's most admired executives before he was fired abruptly last spring for what was vaguely described at the time as misconduct of a "nonbusiness nature." Now details about his personal life are spilling out, and it's clear he was more than just Wall Street's darling.

Details in a motion filed Jan. 15 in Ventura (Calif.) Superior Court depict the former chief financial officer of health insurance giant WellPoint as a corporate Casanova -- a world-class, love-'em-and-leave-'em sort of guy who romanced dozens of women around the country simultaneously, made them extravagant promises and then went back on his word.

Colby helped put together the $16.4 billion deal that created Indianapolis-based WellPoint in 2004. He was named best CFO in managed care for four years in a row by Institutional Investor magazine.

After the company passed him over for CEO last February, it gave Colby thousands of stock options to stick around. But three months later, to Wall Street's surprise, he was out. All WellPoint has ever said is that he was ousted over a nonbusiness violation of the company code of conduct.

By all accounts, the 54-year-old Colby charmed attractive women by showering them with compliments and gifts.

DiCarlo and the other women suing him tell similar stories of aggressive courtship, big promises and broken hearts.

They say that Colby was carrying on with more than 30 women in the last half of 2007 alone....

Colby would supplement such declarations with gifts such as jewelry or trips, the women say.

Meanwhile, the Tampa Tribune reported,

In the wake of federal and state investigations into the company and a stock market free-fall, WellCare Health Plans chief executive Todd Farha and two other executives resigned Friday.

Farha, 39, announced his departure three months after federal agents stormed the company's Henderson Road headquarters Oct. 24. Agents removed documents and computer drives, but the U.S. attorney based in Tampa has not revealed the target of the investigation. The state attorney general's office also is investigating WellCare.

The New York Times added,

WellCare manages benefits for 160,000 elderly customers under Medicare plans and for 1.2 million low-income recipients of Medicaid benefits. The company, based in Tampa, Fla., is being investigated by federal and Florida authorities over possible overpayments, according to court records.

In October, 200 investigators conducted an all-day raid of the company’s headquarters. Several agents interrupted a quarterly board meeting and held directors there for hours of interviews, according to The St. Petersburg Times. They left the campus with a rented truck filled with seized documents.

Two days after the raid, Connecticut officials said they were reviewing whether WellCare hid the extent of its profit on a health insurance contract with the state Medicaid program. The Securities and Exchange Commission is also investigating.

The company has said it is conducting an internal inquiry and is defending itself against a lawsuit filed by a former employee who said WellCare defrauded the government.

Wellcare, by the way, was one of the companies which used to run the the state of Connecticut's Medicaid program, but was ousted from that role after it refused to tell the state about how it reimbursed physicians (see previous post).

To recapitulate, it seems that far too often, managed care organizations and health insurers, whether for-profit or not-for-profit, seem to be not very accountable to the people they insure, much less the physicians they purport to reimburse. Such lack of accountability may foster a corporate culture that puts enriching top managers ahead of providing accessible, quality health care at the most reasonable cost. Although these organizations' leadership may claim to innovate, it is unlikely that their innovation will do much good as long as the leaders remain representative of and accountable mainly to themselves. However, although we talk about it endlessly on Health Care Renewal, opaque, unrepresentative, unaccountable, and/or unethical governance remains off most peoples' and most policy-makers' radar as causing health care to be expensive, inaccessible, and mediocre.

ADDENDUM (28 January, 2008) - see also this comment on paying physicians to prescribe generic drugs on the Clinical Psychology and Psychiatry Blog.

BLOGSCAN - An "Infomercial" for Avandia and Zyprexa?

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody critiqued a newspaper op-ed that ostensibly decried excessive litigation in health care, but also seemed unduly concerned with defending Avandia and Zyprexa, two drugs that did turn out to have more adverse effects than expected.

BLOGSCAN - CME Talks by "Hired Gun, MD"

On the Carlat Psychiatry Blog, Dr Daniel Carlat recounted the career of a "hired gun, MD" who earned an estimated $3 million total from honoraria giving pharma sponsored talks. Is this any way to provide continuing medical education? Would you trust a talk given by such a hired gun? Would you recognize a CME talk given by such a hired gun?

BLOGSCAN - "Lessons from Vytorin"

On Gooznews, Merrill Goozner posits the "lessons from Vytorin," principally, that clinical trials should not be run by pharmaceutical companies, but rather by an independent agency, a la the NIH.

A generation ago, the drug industry accounted for about a third of clinical trials, while academic medical centers, using largely government funds, accounted for two-thirds of the tests. Today, that ratio is reversed. One estimate I’ve seen suggested industry spends over $20 billion a year on clinical trials, well over half of its collective research and development budget.

The time has come to ask whether our privatized system of clinical trial research is serving the nation’s health. The fact that a drug like Zetia can be approved and sold to millions of people for nearly a decade without any evidence that it actually saves lives is absurd.

Lawyers to have cholesterol feast: lawsuits target Vytorin's makers - and, who is responsible for the "confusion?"

In today's news we find that Merck and Schering Plough are coming under lawsuits as a result of the ezetimibe/Vytorin controversy. This was perhaps to be expected:

Lawsuits target Vytorin's makers
Plaintiffs contend the firms knew the drug didn't work.
Sat, Jan. 26, 2008

By Karl Stark
Inquirer Staff Writer

First came the negative publicity, then the lawsuits.

Merck & Co. and Schering Plough Corp., makers of the cholesterol-lowering combination drug Vytorin, are getting hit with a wave of lawsuits asserting the companies knew its product didn't work and delayed telling the public about it.

At least 10 lawsuits have been filed in federal courts, with half the filings in New Jersey, where both parent companies are based. Other federal suits have landed in California, New York, Ohio and Colorado.

The drugmakers "reaped billions of dollars in profits" by failing to release negative results, asserted a class-action complaint filed by a Philadelphia firm on behalf of Lionel D. Galperin of Washington state. The companies also caused patients to spend more money on Vytorin, which sells for more than $100 for 30 pills, compared with a lower-cost generic, the suit alleges.

Here is where I step off the alleged "anti-pharma" bandwagon ... sort of.

While I have criticized Merck's and Schering's mammoth marketing campaign for these drugs here ("Merck and Vytorin ... Who, Exactly, is Confused?") and here ("Full page ads in major newspapers: Does pharma really spend twice on marketing what it spends on R&D?"), I believe lawsuits with the slant of "Bush lied, people died" (i.e., the firms knew the drug didn't work but withheld the information) are both unmerited and especially unhelpful to those attempting to advance medical science.

This claim is in part based on the following:

The companies completed the [Enhance] study [on these drugs] in April 2006 but did not release preliminary results until a press release was issued on Jan 14 [2008]. That was more than a month after congressional investigators had written to company executives, asking about the delay and demanding documents.

The implication is that actual knowledge of the results were withheld from the public to protect the drug. I do not believe this to be the case. I recall genuine excitement at Merck about Zetia's cholesteral-lowering effects, and great confidence that it was a true breakthrough drug that would generate much needed revenue after multiple drug failures and patent expirations. Clinical medicine, however, is full of surprises.

While such excitement could motivate a company to withhold negative new information, I have a different interpretation of why such delays occurred. Pharma is in a state of downsizing. At Merck, a company that carried on a succcesful business for over 100 years without downsizing, the mass downsizing that began in Nov. 2003 and continues to this day was a major cultural "hammer over the head."

Such social changes tend to sink morale very severely. While Catbert the Evil HR Director might find this amusing, most productive poeple do not. It's also something that cannot be "massaged away" with HR propaganda and "employee appreciation days." As I noted in "Happy Accidents in pharma doubtful: Tax Break Used by Drug Makers Failed to Add Jobs" here, the stress of losing a job is like the stress of a death in the family or a divorce, and the stress of fear of losing a job is also pretty darn bad. As the Alaska state government piece on "surviving a layoff" cited in the above posting states, "remaining employees become overworked, burned out, extremely unhappy and put in a position of fear and uncertainty." It doesn't exactly take a rocket scientist to realize this.

Anecdotally, I reside in a Merck community and hear as much about morale from my local car dealer, haircutter, family medicine physician, restaurant waiters, and others. In fact, I don't believe clinical trials information was withheld deliberately. I believe morale is low, departments are understaffed, and people are playing "CYA" like their lives depended on it (as their careers and ability to pay mortgages and support families depends on their jobs, this is actually not unwise).

Taking morale issues into account, and adding in the three late-stage pre-launch drug failures of 2003, resulting cultural shift to mass layoffs, and the Vioxx debacle, extra long "CYA" to make sure the data and conclusions are correct is understandible in context.

In such an environment, where overworked, stressed out people basically give themselves (effectively speaking) hourly pay raises via doing less per hour, and return to seeing jobs as a value-for-value proposition where an employee in a mirrorlike fashion gives a company what it has earned (i.e., deserves) in terms of their committment and willingness to make sacrifices, long delays in handling complex clinical trials results sets - this study, of course, being just one of many - is not at all surprising.

In addition, politics being what they are in any corporate layoff, many good people (the movers and shakers) get laid off, and other good people can't stand the environment and leave for greener pastures. This leaves behind many less capable colleagues to pick up the slack. I believe the cause of the delays in data release are more likely to be found attributable to low morale, a lesser % of "stars" among the workforce than necessary for optimal effectiveness, dysfunctional self protection-style politics, and resultant lowered productivity.

As an aside, it would not surprise me if recent chemical spills of "liquid mustard gas" into the creeks in my community had at its roots a similar cause:

Pharmaceutical giant Merck has agreed to pay $20 million in assorted fines, environmental improvements and cleanup costs to make up for killing untold fish, fouling drinking water supplies and spoiling a season of recreation on the Wissahickon Creek in Pennsylvania with a toxic "liquid mustard gas," the Philadelphia Inquirer is reporting. The massive impact came from an old-school problem: Dumping toxic chemicals down the drain at a vaccine plant, from which they reacted with chlorine disinfectants and washed into the creek, wreaking havoc downstream for miles.

I do not believe the company would deliberately withhold clinical trials data, and therefore do not believe a "deliberately withheld" charge is reasonable with regard to the ENHANCE clinical trial results on ezetimibe (Zetia) and ezetimibe-Zocor(Vytorin) . If there is a good basis for a lawsuit, perhaps the people who should be sued are those in management and in consulting organizations that recommended layoff strategies and stole the soul of such a once-stellar company.

The newspaper also notes the following:

...The drugmakers aren't the only ones facing scrutiny. Both the American College of Cardiology, which represents most cardiologists, and the American Heart Association echoed the companies' assurances and urged patients on Vytorin not to panic after a major test of Vytorin was released on Jan 14. But their stands have drawn criticism from congressional investigators and others because both groups take in substantial sums from pharmaceutical firms.

I'm not going to comment further on this other than to say "that sounds familiar", as the conflict of interest issue affecting medical professional societies has been well addressed by my Healthcare Renewal colleagues.

I will, however, comment on this:

W. Douglas Weaver, president-elect of the cardiologists, echoed those concerns. "We really had huge numbers of patients calling physicians' offices and not knowing how to interpret this information," Weaver said. "People were discontinuing statins because of the confusion."

The unstated but not-so-subtle implication (to those who understand marketing and "spin") appears to be that the big, bad, "anti-pharma" zealots and their allies in the media have gotten the poor public all confused, and the public is stopping their lifesaving meds as a result.

Having been involved in drug nomenclature activities at Merck as well as being familiar with the work of groups such as the Institute for Safe Medication Practices, one major goal in drug naming is to prevent confusion regarding the drug's nature and purpose. One creates drug names to assure that one drug is not confused for another, by healthcare professionals, patients, and others. Information scientists and others work very hard to select names for drugs that do not "resemble" others in spelling, phonetics, etc.

Now, just who is responsible for the confusion among patients "discontinuing statins because of the confusion?"

It seems to me the brainiacs who came up with the marketing scheme of giving a combination drug consisting of a newly-generic drug and a newly-approved one an entirely new name to milk more income out of a drug going generic -- and effectively discourage doctors/patients from simply prescribing/taking two pills (the generic and the new one) -- are largely responsible.

How many patients really understand that their wonder drug has two parts, one old, one new, that they could purchase and take separately likely for less cost than the combination, and that only the "new" part has come under scrutiny? How many understand that if the statin part of the new combination drug doesn't agree with them, they would have to discard the drug instead of simply replacing the statin? In addition, do busy general practice physicians understand this? One wonders.

It therefore seems the marketing folks as well as the drug naming approval organizations and the FDA carry significant blame for the "confusion." Perhaps this is a case of the unexpected (or should I say the predictable but undesired?) happening that provides evidence drug combinations should not be given snappy new names or approved as expensive "new" drugs.

Finally, I cannot but think it ironic that just as VIOXX and other similar drugs may have caused platelets and/or blood vessel walls to become more "sticky" and create vascular side effects, so ezetimibe might cause cholesterol and/or blood vessels to be more "sticky" for reasons not yet understood and negate some of the cholesterol lowering effects. It would be ironic indeed, as the newspaper article suggests by the observation "the combination drug failed to provide any benefit and even performed slightly worse than Zocor alone", if long term studies show ezetimibe to create more harm than good.

However, clinicians, the company and the regulators should be prepared if this occurs to get the data out ASAP when it is available fron ongoing studies - low morale or not.

-- SS

Government Health IT Webcast featuring MedInformaticsMD: The Problem With EMR's

Readers of Healthcare Renewal know of my views on Healthcare Informatics and clinical IT such as electronic medical records. I am a passionate supporter of clinical IT, but believe the industry is still immature, employing a leap of logic - faith? - that impairs results. Namely, the almost religious and mostly unchallenged belief that the leadership, assumptions, culture and methodologies of what I call "business computing" or M^3 computing (M cubed - management, mercantile, and manufacturing) computing are appropriate, if not the only approach, to the computing subspecialty of clinical computing.

In postings here and here I wrote on my concerns about an "irrational exuberance" over EMR's that seems to be sweeping the healthcare industry. The former post, I believe, caught the attention of an editor at Government Health IT. The end result of our conversation was a webcast in which the editor interviewed me on the issue.

You can listen to the webcast here. It is entitled "The Problem with EMRs."

So far, I've had a number of positive responses and a few speaking engagement invitations. I have not yet been called a luddite or technophobe. Considering my website on health IT difficulties has been viewed 500+ times via a link the Government Health IT story, I consider this a minor miracle.

-- SS

Lux et Veritas, or Trust But Verify? Yale discovers eDiscovery

Recent amendments to the Federal Rules of Civil Procedure concerning the discovery of “electronically stored information” have created headaches for organizations that rely extensively on digital information and communication technologies (ICT's). Which includes most organizations in the 21st century. No fooling.

Roy Poses has written about conflicts of interest and other forms of ethical problems in academic medical centers in posts such as here, here and here.

Add Yale to the list. Further, add Yale to the list of organizations discovering the eDiscovery is no laughing matter. In this presentation (Powerpoint .pps file) by Yale's Information Technology Services entitled "What The New e-Discovery Rules Mean to Me", we discover that Yale has perhaps discovered the wages of professorial sin.

Those wages are June 26, 2006 subpoenas from HHS, NIH, DoD, NSF, and NASA regarding all information related to 47 grants from 13 departments. The FBI was involved, with FBI agents going at night to faculty and staff homes and to one vacation destination for questioning (that must have been worthy of scenes for a movie). The investigations are apparently still underway.

The issues include allocation of research expenses, reporting of faculty effort devoted to grants (i.e., claiming 25% of time is devoted to five grants), and numerous matters relating to grant administration including: cost transfers, allocation of expenses, effort, administrative charging and subaward monitoring, and conflict of interest.

Of note is a Feb. 2006 HHS audit of a Yale subcontract from UMass Medical School causing $194,000 of a $572K NIH award to be disallowed due to irregular cost transfers, effort % allocation, and cost allocation methodology. This may have been a trigger for further inquiry.

For starters, 600+ individuals were named as "people of interest", 400+ accounts were put on legal "hold" status, 100 individuals's disks were 'captured.'

In an example of the perils of eDiscovery and unethical people, an altered email was discovered. A reference to "spending down" a subgrant that was soon to expire had been deleted.

Yale president Levin wrote in the Yale Daily News that "the amount of documents that have been requested by the federal government amounts to ... hundreds of thousands, even millions of pages." An entire floor of class A office space was reserved for the auditors and lawyers reviewing documents.

The IT department actually ran out of tape and disk storage in backup system servers (probably due to legal hold requirements), people became afraid to delete anything, and of course there was "tension" between faculty and administration regarding mandatory faculty training in research administration and in actually obeying the directives for document preservation and retention in fulfilling the federal subpoenas ("Faculty Object to Searches, Yale Daily News, Feb. 2, 2007):

As a federal investigation into possible mismanagement of grant monies at Yale enters its eighth month, some professors are speaking out against what they say is an inappropriately invasive response from the University.

At a faculty meeting Thursday, some science professors said the University is impinging on privacy and academic freedom by copying documents from professors’ hard drives and requiring faculty members to undergo mandatory training or supervision in the grant administration process. But administrators said they have already addressed one of the faculty’s concerns about the training, and that they have simply taken steps required by government subpoenas.

Imagine that, tenured Ivy professors having to undergo mandatory training in how to administer federal money appropriately and turn over records. The horror! Must be a Karl Rove/Joe McCarthy/David Horowitz plot to destroy academic freedom!

The resources required for production are perhaps yet another cost of doing academic business "the old fashioned way."

It is amazing that this story has received precious little coverage nationally. The NYT had a brief article in 2006. I only heard about this recently, from a former colleague. Perhaps this is another example of the Anechoic Effect.

Yale's clinical operations have seen federal investigation once before. See "Insufficient IT Management Depth Results in Justice Dept. Investigation, Millions of Dollars in Fines."

That story was more about incompetence rather than malfeasance, however. Ironically, when I was Yale School of Medicine junior faculty in Yale Center for Medical Informatics, I was charged with teaching postdoctoral fellows about NIH ethics guidelines. The tenured senior faculty I was working for just didn't have the time. See "Anti-social informatics at Yale" for a flavor of Yale kultur:

At that link is a detailed case example from the late 1990’s of impaired efforts to implement clinical information technology via wasted resources and opportunity, attempted misappropriation of intellectual property by prominent tenured faculty for private use, unauthorized practice of law in the Office of the General Counsel, blacklisting, extortion, and retaliation treated with a blind eye and silence by university officials at this prominent university.

I am not at all sorry to see this latest investigation. I believe Yale needs a house cleaning. I am going to attempt via the FOIA to find out who, if anyone, has been found to have been "naughty" via the federal investigations.

While I am perhaps experiencing a degree of Shadenfreude, the current situation is very unfortunate for society, of course. Time and effort that could have been spent improving society is being spent trying to uncover and correct behaviors of the privileged and protected involving taxpayer money -- at taxpayer expense, of course. Let's hope Yale can live up to its motto of "Lux et Veritas." My experiences showed that motto to ring just a bit hollow (or, perhaps a better metaphor would be that the motto was just a bit transparent).

Finally, by way of speculation, the DoD has also had its issues with Yale. Payback time, perhaps?

-- SS

Full page ads in major newspapers: Does pharma really spend twice on marketing what it spends on R&D?

At this post ("Merck and Vytorin ... Who, Exactly, is Confused?") I commented on a full page ad (actually it's a two page ad, where page 2 includes prescribing information) being run by Merck and Schering Plough in the Philadelphia Inquirer to defend drugs Ezetimibe and Vytorin. I predict it is running in other papers in other major markets as well.

I first saw the ad on Tuesday, Jan. 22. It has appeared in the Inquirer every day since, today included. That's at least four days; I don't know when the ad started.

The cost for the ad must be significant. It certainly gives life to the findings that pharma spends twice on marketing what it spends on R&D.

-- SS

Addendum: readers mentioned it also appeared in The Akron Beacon Journal, Boston Globe as well as The Wall Street Journal. I venture is has been in many others as well.

Logical Fallacies and the Discussion of Health Care Policy: Examples Courtesy of DrugWonks.com

On the DrugWonks blog, blogger Robert Goldberg seemed terribly perturbed about Health Care Renewal, and me in particular. In the last week, he devoted two posts to disagreeing, to use a polite term, with me and this blog, and threw in parenthetical comments about me and this blog in two other posts. It is not exactly clear what I wrote that set him off. He never linked to particular posts, or quoted anything I actually wrote. My best inference is what most recently raised his ire was this post about conflicts of interest related to two public pronouncements by influential health care not-for-profit organizations urging patients and physicians not to abandon Zetia and Vytorin.

His posts are entitled "Beware of All Innovations, Especially New Ones," "Sanctimony About Vytorin's 'Secret' Panel,", "Everyone has a right to their own opinion as long as they agree with me," "Why the Media and Pharma Blogsphere Fails to Get Personal."

We have previously posted about op-eds in the mainstream media written by Robert Goldberg, and his boss, Peter Pitts, which have also featured logical fallacies (here, here, here, and most recently here.) Goldberg also once used DrugWonks as a platform to try to discredit Health Care Renewal, again making use of logical fallacies (see post here).

We have noted before that Goldberg works for the Center for Medicine in the Public Interest, whose president, Peter Pitts, is 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. Furthermore, in a post on Drugwonks, Goldberg acknowledged "CMPI accepts grant from drug companies -- and we do so proudly because they actually invent things that help people." In the op-eds noted above, neither Pitts nor Goldberg acknowledged their relationships to the pharmaceutical industry, giving us reason to label their writings in the media stealth health policy advocacy.

Goldberg's latest set of writing are notable mainly for their creative use of multiple logical fallacies. So to try to make some lemonade out of the lemons he has provided, let me respond to some of his points sorted by the kind of fallacies they represent, with discussion of the definition of these fallacies and how they were deployed. All definitions used here were from the Nizkor Project.


A Squadron of Straw-Men

The straw-man argument seems to be a favorite of Goldberg's. One working definition of the straw-man fallacy is: "The Straw Man fallacy is committed when a person simply ignores a person's actual position and substitutes a distorted, exaggerated or misrepresented version of that position." Here are some examples, in the order they appeared in his posts.

• "the Poses postulates" - In "Beware of All Innovations...," Goldberg invented a set of exaggerated postulates purportedly for the use of pharma-skeptics. They begin with "don't trust Pharam research or the researchers they pay," and go downhill from there to "don't use any drugs...." Obviously, the first could conceivably be an exaggeration of some things I have written, and the last is plain ridiculous. Also obviously, I never proposed anything remotely like these. So this is a quintessential straw-man fallacy. Goldberg has simply made up words and then attributed them to me.
• "this also should apply to Zocor," - In "Sanctimony About Vytorin's...," a post which starts by criticizing me as "insufferable," Goldberg seemed to imply that I suggested "people should stop taking SSRIs, Avandia, and Vytorin." He then added "now I guess this should also apply to Zocor." I have criticized the suppression and/or manipulation of clinical research about SSRIs, Avanda, and Vytorin, and noted that it is not clear that the benefits of the latter two drugs outweigh their harms. I have never had reason to directly discuss Zocor (simvastatin, by Merck), a commonly used statin lipid-lowering drug. I certainly never suggested that it not be used.
• "anyone who consults for drug companies is a prostitute and endangers the public health," - Also in "Sanctimony," Goldberg suggests I expressed this extreme sentiment. I surely have written about concern that medical academics who also have financial ties to commercial health care firms are hard pressed not to be influenced by such ties. But I never used the p-word in this context.
• "And he presumes that the only source of bias that affects the public health adversely - mostly without empirical evidence - is financial inducements from drug companies," - In "Everyone has a right...," Goldberg directly misrepresented my position as above. If he bothered to read Health Care Renewal, he would find that I (and our other bloggers) have been equal opportunity offenders, skewering deceptive marketing, conflicts of interests, and other such practices involving all sorts of health care organizations, not just pharmaceutical companies.
• "By his standards, Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one...," - This appeared in "Everyone has a right...." To be concrete, I don't think I have ever mentioned any of these luminaries in Health Care Renewal. More importantly, all these scientists were best known for basic research, and they all did their major work before the rise of pharma as a major sponsor of clinical research. All I have written about conflict of interest, research manipulation, and research suppression has been about clinical research, that is, research on intact human beings. I have been most concerned with influence by the manufacturers of particular products on human research that tests the products they make. The issue has never been commercial funding of basic science. So Goldberg's assertion in this case was certainly the biggest collection of straw so far.
• "So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind eye towards other sources of conflict." - Again, in "Everyone has a right," Goldberg demonstrates that he is not a faithful HCR reader. As noted above, we have criticized all sorts of conflicts of interest, involving not just pharma, but device, biotechnology, managed care, hospital suppliers, etc, etc. More straw piled on the camel.
• "And who said the conclusion of ENHANCE was to lower cholesterol at all costs? Roy Poses?" - This was in "Why the Media...." Of course, I didn't say that. Enough straw-men to break any camel's back.

Accusations of Guilt by Association

A working definition, "Guilt by Association is a fallacy in which a person rejects a claim simply because it is pointed out that people she dislikes accept the claim."

• "There is no doubt Poses is part of the 'I hate Pharma' crowd...." - Goldberg wrote this in "Everyone has a right...," This has elements of a straw-man too, since, as noted above, I have written quite a lot about health care organizations outside of pharma. Clearly, though, Goldberg has lumped me into an amorphous group whose existence is as plausible as Hillary Clinton's "vast right wing conspiracy."
• "the failure of the I hate pharma crowd in the media and blogsphere...." - This was in "Why the media...." See comments above. I guess Goldberg doesn't think I'm in with the in-crowd.

Down the Slippery Slope

A working definition, "The Slippery Slope is a fallacy in which a person asserts that some event must inevitably follow from another without any argument for the inevitability of the event in question. In most cases, there are a series of steps or gradations between one event and the one in question and no reason is given as to why the intervening steps or gradations will simply be bypassed. " Goldberg tended to employ slippery slopes in conjunction with straw-men.

• "the Poses Postulates" - Again, as noted above, these were certainly not my postulates. The postulates themselves were a fairly classic slippery slope, starting with exaggeration, "don't trust Pharma," proceeding through this dubious reasoning, "Don't trust the drugs they produce or market since the FDA is nothing but a tool of pharma," and ending with the ridiculous, "don't use any drugs...."
• From "any financial ties is a conflict," through "people should stop taking SSRIs, Avandia, Vytorin. Now I guess that should also apply to Zocor." Again, this was noted above as a case of a straw-man fallacy. Goldberg constructed his straw-man so as to slide down a slippery slope.

Fishing for Red Herrings

Working definition: "A Red Herring is a fallacy in which an irrelevant topic is presented in order to divert attention from the original issue. The basic idea is to 'win' an argument by leading attention away from the argument and to another topic."

• "Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to 'natural' cholesterol lowering products that they sell, etc." - Goldberg wrote this in "Everyone has a right...." Obviously, whether or not such web-sites exist, whether or not they are abusive, and whether or not I have noticed or commented on them has no bearing on whatever I wrote about ezetimibe, clinical research on it, etc that so offended Goldberg. (Goldberg actually never clearly referred in any of these posts to anything specific that I wrote, so what so offended him was never clear.)
• Goldberg wrote two paragraphs about alleged conflicts of interest affecting the Prescription project, then "Should Poses be suspicious about the choice of drugs made by the Prescription Project based on their source of funding? Not a peep." - This again was in "Everyone has a right...." Again, this is irrelevant to the ezetimibe controversy. I have tangentially referred to the Prescription Project on this blog, but not in a way that is relevant to anything else Goldberg was talking about.

For Latin Lovers, Ad Hominem Tu Quoque

This may not be the most well-known fallacy, but its working definition is: "This fallacy is committed when it is concluded that a person's claim is false because 1) it is inconsistent with something else a person has said or 2) what a person says is inconsistent with her actions. "

• After making the straw-man argument that I would have labelled a host of Nobel Prize winning basic scientists as untrustworthy, "while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses [sic] just got one Merck grant back in 1997-1999 (which he never declared in his blog.)" - This appeared in "Everyone has a right...." The argument seems to be that anyone who ever had a relationship with a pharmaceutical company of any type can never criticize anything to do with such relationships. (In a funny way, Goldberg thus seemed to be making an argument for how conflicts of interest do influence what people say and do.) I freely admit I was the Principal Investigator of a grant sponsored by Merck, and paid to the hospital which employed me. Why that singular relationship ten years ago should discredit my current arguments about conflicts of interest, arguments which Goldberg never directly addressed, is, to be charitable, not obvious.

Joe Collier wrote succinctly in the British Medical Journal, [Collier J. The price of independence. Br Med J 2006; 332: 1447-9.] "In my experience, people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." Goldberg's latest writing seem to demonstrate this well.

The writings of Goldberg and Pitts probably inadvertently have provided a great set of teaching cases about how logical fallacies can be used in persuasive writing to put forward dubious, and conflicted postulates. A working knowledge of logical fallacies should help readers separate the wheat from the chaff in the cacophonous clamour about the current crisis in health care. Some useful web-sites for those interested in logical fallacies are the Nizkor Project: Fallacies, LogicalFallacies.info, and the Fallacy Files. (I'm sure there are others.)

ADDENDUM (28 January, 2008) - Goldberg has also taken issue with Dr Howard Brody (of the Hooked: Ethics, Medicine and Pharma blog) and Dr Daniel Carlat (of the Carlat Psychiatry Blog), and then with Dr Aubrey Blumsohn (of the Scientific Misconduct Blog). See if you can spot the logical fallacies in Goldberg's pieces. Then see Dr Brody's reply here.

BLOGSCAN - Conflicts of Interest, CME, and MECCs

On the Carlat Psychiatry Blog, Dr Daniel Carlat reported an alternative take on the Macy Foundation report which called for the abolition of commercial funding of continuing medical education (CME). (See Dr Carlat's earlier post on this report here.)

In a seminar on medical ethics, Harvard University's Neurologist-in-Chief, Dr Martin Samuels, trashed the Macy report on the basis of, you guessed it, conflict of interest. He charged that one of the members of the conference that produced the Macy report was a top executive of UpToDate, a medical education and communication company (MECC) that makes its money by selling subscriptions, not from drug companies. Meanwhile, Dr Carlat also reported that Dr Samuels was praising yet another MECC, Pri-Med, for which he happens to direct a neurology course.

You can't tell the conflicts of interest without a scorecard. This story does seem to underline, in my humble opinion, the need to disclose all conflicts of interest, and the need to develop a structure for medical education (undergraduate, graduate, and continuing) that somehow avoids conflicts due to relationships with any organization, drug company, managed care organization, MECC, for-profit, not-for-profit, whatever that have vested interests other than discovering and disseminating the truth in a spirit of free enquiry (that is, the fundamental educational mission.)

We physicians also ought to remember the oaths we once swore, and stop trying to figure out clever deals to make more money on the side.

Variations on a Theme of Sleaze

VARIATIONS ON A THEME OF SLEAZE

A few days ago I posted on corrupt reports in two medical journals, where key opinion leaders (KOLs) and corporate employees misrepresented the potential of Janssen’s atypical antipsychotic (AAP) drug risperidone for depression. One of these reports appeared in a general medical journal, Annals of Internal Medicine (AIM), which confirms the designs of the corporate marketers: by volume, treatment of depression now is centered in primary care. Considering the weak efficacy data, the dubious risk-benefit profile, and the inferiority of AAP drugs to other options, there is no justification for the broad and early adjunctive use of these agents for depression in primary care. The Eli Lilly Company, which markets the combination of olanzapine and fluoxetine in a single pill (Symbyax), has the same objective. Other companies are moving rapidly into this market space.

Combining AAP drugs with antidepressants takes us back to the bad old days of antidepressant-antipsychotic drug combinations like Triavil in the1960s and 1970s, when we learned that depressed patients are especially susceptible to a serious adverse event known as tardive dyskinesia (TD) caused by antipsychotic drugs. While the risk of TD is less than with the early antipsychotic agents, it is still unacceptably high with AAP drugs for patients who are unlikely to show meaningful clinical benefit, as I detailed earlier. In adult patients with schizophrenia the risk of TD with olanzapine treatment is about 2.5% at 1 year. In children and adolescents treated with AAP drugs for 6 months the risk is an alarming 6% (Wonodi I et al Movement Disorders 2007; 22: 1777). In patients with mood disorder, these figures are likely to be higher. And this is before one even begins to factor in the metabolic toxicity of AAP drugs (weight gain, obesity, insulin resistance, and Type II diabetes mellitus)! Patients are not well served when AAP drugs are pushed for treating depression in primary care.

Medical journals are not the only compromised medium. Continuing Medical Education (CME) is a second front in the campaign to expand the AAP drug market. The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar.

ACCME standards include clear identification of off-label drug use; full and fair disclosure of clinical trial results, warts and all; and clinical guidance to the audience about risks, benefits, and treatment options. It is not an exaggeration to say that these standards are more often honored in the breach than in the observance. That is because CME events have been degraded to little more than thinly veiled advertising, built around promoting a product rather than around education. So corrupted has the process become that the Macy Foundation recently recommended that industry financing of CME be ended, “whether such support is provided directly or indirectly through subsidiary agencies.” See Daniel Carlat for more on this topic. Is this position alarmist? Consider the following examples of corruption in CME.

A widely advertised CME program appeared on-line 6 November 2007, titled Treatment-Refractory Depression: Is there a Role for Atypical Antipsychotics? Note the leading question and the product category focus. The program was developed by the MECC PeerView Institute for Medical Education, and it was sponsored by the Semel Institute for Neuroscience and Human Behavior at UCLA, which certified CME credits. Like the journal articles I discussed last week, this CME program is marked by a concatenation of deceits. The major messages were, augment earlier rather than later; AAP drugs are “an emerging therapeutic option” for augmentation (note the branding language); and AAP drugs are efficacious. None of these messages is based on credible evidence.

The first sleight of hand was the leadoff presentation, which featured the STAR*D study results concerning remission and response rates to adjunctive treatments or switching after various levels of treatment failure. The data naturally suggest unmet needs in treating depression (a favorite theme of marketers). The unspoken implication of this academic veneer is that the later studies described in the CME program were comparable to the STAR*D study in terms of case material, which is not so. Recruitment to STAR*D was explicitly different from recruitment to the usual experimercial sponsored by a drug company, where many cases come from contract research organizations, not from clinical referral streams. Moreover, STAR*D was a purely descriptive study that by design could not identify specific treatment effects.

Charles B. Nemeroff, MD, PhD from Emory University (yes, the same) discussed short term use of AAP drugs. His presentation is a model of being economical with the truth. Dr. Nemeroff has clearly mastered the art of accommodating his many corporate clients. He discussed 4 atypical antipsychotic drugs as augmenting agents for nonresponding depression. When discussing olanzapine he went beyond his short term remit to suggest that long term treatment is efficacious, yet he neglected to address the neurological or metabolic toxicity of long term olanzapine. When discussing risperidone he did not disclose that he was senior author of the major report he described and cited; he neglected to disclose the retractions he and Mark Rapaport from Cedars-Sinai Medical Center had been obliged to publish; he neglected to disclose that treatment with risperidone beyond 6 weeks was no more efficacious than placebo. That aspect was discussed by another speaker, who repeated Dr. Nemeroff’s now-retracted and discredited claims for significant long term preventive efficacy of risperidone in a subgroup of patients. Dr. Nemeroff made further claims about risperidone improving sexual function in patients receiving an SSRI antidepressant but he failed to disclose that beyond 6 weeks risperidone impaired sexual function in women who were receiving the SSRI; he backed up his claims about risperidone and sexual functioning by citing his publication in his own journal Neuropsychopharmacology that contained no data whatsoever on the matter; and he neglected to address the metabolic toxicity of risperidone that the corporation disclosed on ClinicalTrials.gov. He also falsely stated that the short term efficacy of risperidone in nonresponding depression was demonstrated in a controlled study, citing his own open-label study. These problems were called to the attention of the Semel Institute for Neuroscience and Human Behavior at UCLA. In response, the CME program was revised on January 11, 2008. Dr. Nemeroff’s material now contained a different citation that again contained no data concerning sexual side effects. They removed the claim that the short term efficacy of risperidone had been established in a controlled trial (although by then the problematic report of this very issue in AIM had been published for over 2 months). The inadequate discussion of the toxicity of risperidone in Dr. Nemeroff’s trial was unchanged, and another speaker continued to repeat the retracted and discredited claims of Dr. Nemeroff for significant long term preventive efficacy of risperidone in a subgroup of patients. No explanation of the changes made on January 11, 2008 in the on-line materials was provided by UCLA to CME readers who had studied the erroneous and biased material for more than 2 months. Other speakers made passing reference to the metabolic toxicity of AAP drugs but only in a perfunctory way that had no educational value, like what we see in direct-to-consumer advertising. Nobody mentioned the risk of TD.

As the Macy Foundation report makes clear, CME providers are expected to give learners guidance on the risk-benefit balance of new treatments. It is disingenuous of Dr. Nemeroff to talk up risperidone for short term treatment of these difficult depressions by exaggerating the benefit, downplaying the risks, avoiding comparison with alternative treatments, and glossing over the problem of longer term loss of efficacy. These are clear violations of ACCME principles.

When discussing aripiprazole for nonresponding depression, Dr. Nemeroff once again was economical with the truth. Note that Bristol-Myers Squibb, the marketer of aripiprazole, sponsored this PeerView/UCLA program. To document his claims about aripiprazole, Dr. Nemeroff cited one Abstract from the American Psychiatric Association meeting in May 2007. That does not meet ACCME standards of documentation for learners, most of whom would be unable to access the cited Abstract (not that it would tell them much even if they could). For some reason, Dr. Nemeroff did not inform learners that the complete report of the aripiprazole study had appeared in June 2007 (Berman RM et al. J Clin Psychiatry 2007;68: 843-853), fully 5 months before the CME event went on-line. From that readily available report it is clear that the Number Needed to Treat (NNT) for response with aripiprazole is 10, which compares unfavorably with a NNT of 4 for lithium, the best established augmenting option in placebo-controlled trials. A NNT of 10 means a clinician would need to treat 10 patients with aripiprazole before obtaining one remission that would not have occurred anyway with placebo. That does not constitute compelling clinical benefit. Dr. Nemeroff did not candidly discuss these troubling data. Dr Nemeroff provided his CME audience none of the remission or response data from the published aripiprazole study, though these data were readily available. These omissions of published, highly relevant information signify disrespect for his audience by Dr. Nemeroff, incompetence by the MECC, and failure of due diligence by the accrediting institution, UCLA, to ensure that accurate, balanced information and adequate documentation are provided. Likewise, no substantive risk-benefit analysis was provided to guide CME learners, and there was no meaningful discussion by Dr. Nemeroff of the metabolic toxicity of aripiprazole. The published report tells us that 7.1% of patients treated with aripiprazole gained more than 7% body weight, a very significant difference (p < 0.01) from the placebo treated patients (1.2%). Dr. Nemeroff did not share that information with the CME audience. Instead, he slyly minimized the appearance of the problem by showing a mean weight gain of only 2 kg with aripiprazole. In addition, the neuromotor toxicity of aripiprazole was remarkable (23.1% akathisia and 27.5% extrapyramidal symptoms). Dr. Nemeroff gave the CME audience no guidance about that problem or about its unblinding effect in the trial. Why do highly paid KOLs behave in this way? Do they think nobody will notice?

A final insult to CME learners in this program was the disclaimer that “The Semel Institute for Neuroscience and Human Behavior at UCLA is responsible for the selection of this report’s topics, the preparation of editorial content, and the distribution of this report” but “No responsibility is taken for errors or omissions in these reports.” Well, then, who is responsible? Why not UCLA, considering the ACCME standards and the fees UCLA received for sponsoring this CME activity through an “educational grant” from Bristol-Myers Squibb Company? Overall, it is difficult to avoid the impression that this so-called CME activity is a meretricious infomercial for Dr. Nemeroff’s corporate clients rather than a balanced educational event that aims to give practitioners considered guidance on a difficult clinical problem.

Will these revelations slow the marketing-inspired momentum for use of atypical antipsychotic drugs in depression? Not likely. Indeed, a new road show is right now getting under way, bringing the good news about atypical antipsychotic drugs in depression to CME audiences in Miami, San Francisco, Los Angeles, Chicago, Boston, and New York. Why now? Has some new insight been achieved that requires urgent communication to physicians? No. The road show has been launched now because aripiprazole was recently approved by the FDA for the secondary indication of adjunctive treatment in depression. It’s all about marketing. The faculty speakers are the usual suspects – KOLs and KOL wannabes who enjoy cozy or nepotistic relationships with the chairman. The funding is through another “educational grant” from the marketers of aripiprazole. The CME sponsor is an outfit in Texas that knows how the CME game is played. And the chairman of this new enterprise? Why, none other than the compromised Dr. Charles Nemeroff from Emory University. Why are we not surprised?