"Key Opinion Leaders Were Sales People for Us"

The role of key opinion leaders (KOLs) in marketing drugs and devices has been frequently discussed on this blog (see posts by Dr Bernard Carroll here and here), and on other blogs, such as the Carlat Psychiatry Blog and the Clinical Psychology and Psychiatry Blog.

The British Medical Journal just published an article providing further documentation about how such KOLs function. [Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? Brit Med J 2008; 336: 1402-3. Link here.] The article was based on a discussions with a long-term pharmaceutical representative who was several times "a top national salesperson," and articles in several business publications. Some key points were:

• Key opinion leaders are salespeople: "Kimberly Elliott, who was a drug company sales representative for almost two decades in the United States, puts it directly. 'Key opinion leaders were salespeople for us....' Also, "Ms Elliott says drug companies desperately need key opinion leaders. 'There are a lot of physicians who don’t believe what we as drug representatives say. If we have a KOL [key opinion leader] stand in front of them and say the same thing, they believe it.'"
• Key opinion leaders are expected to increase drug or device sales: Kimberly Elliott said "we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations," she said. "If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back." Also, "the industry’s Richard Tiner, accepts that drug companies often recruit senior specialists and evaluate the return on investment they may bring. They become an integral part of the company’s marketing, education, and research strategies. 'When these people are receiving a fee, they are in one sense in the employment of the company,' he says...."
• Key opinion leaders are meant to parrot their corporate patron's marketing message: "These people are paid a lot of money to say what they say. I’m not saying the key opinion leaders are bad, but they are salespeople just like the sales representatives are." Also, an industry publication said, "drug companies are then encouraged to evaluate the performance of their key opinion leaders continuously to avoid 'wasting money on the wrong people.'" Lectures were "largely based on slides supplied by the company."
• Key opinion leaders are well-paid: "Ms Elliott says she would pay these respected doctors $2500 (£1280; 1610) for a single lecture...." Also, "A publicly available summary of one report shows that some doctors can earn more than $25 000 a year in advisory fees. A press release promoting the other report suggests that the average fee paid to a doctor for a "scientific speech" is more than $3000."
• Physicians who show favor to particular products are groomed to be opinion leaders: "Importantly, marketing staff should find doctors who will endorse their products, 'who may be further down the influence ladder," and then help "raise their profile, and so develop them into opinion leaders.'"

Although pharmaceutical, biotechnology, and device company spokespeople, and some of the industries' cheer-leaders continue to insist that key opinion leaders are educators, this article underscores that they are merely high-priced marketers. What is most insidious about the use of KOLs, however, is that many of them do not acknowledge that they are even influenced by the money they are paid.

In my humble opinion, any physician or other health care professional paid as a key opinion leader should acknowledge that pay, its amount, its source, and its purpose in detail any time they express an opinion relevant to their corporate sponsor's products or services. If disclosing "I was paid $2,000 by company x to give this talk, using slides the company provided. Company x makes drug y. The purpose of this talk is to market drug y" might make some KOLs uncomfortable, then maybe they should reconsider the compromises they have made by accepting this role.

Any physician or health care professional, however, who does not make disclosures at least this detailed when speaking or writing on a topic relevant to the marketing of his or her corporate sponsor's products or services is being deceptive and dishonest.

House of Representatives Hearing on HIT: an Action Alert from the Assoc. of American Physicians and Surgeons

Received this from the Association of American Physicians and Surgeons, a conservative group. I largely agree with their points (my comments in red italic):

Action Alert - House Hearing on HIT
6/20/2008

The Health Subcommittee of the House Committee on Energy and Commerce will be holding a hearing on Health Information Technology legislation next week. If your member of Congress is listed below, please contact his office by Tuesday morning of next week. Ask to speak to the health LA (legislative assistant). Tell him you are a doctor and explain briefly why the federal government should not be promoting, mandating, or funding Health Information Technology. This needs to develop in the free market; the congressman should oppose all HIT legislation.

AAPS Talking Points:

1. It is an unconstitutional intrusion into private affairs. Congress has no constitutional authority to dictate how private medical records should be kept. The only nexus for the exercise of such power is the filing of a claim for federal payment. Thus, any records related to services for which no federal claim is made must be exempt.

[Not only do they have no authority, they have no expertise in the complexities of EMR, complexities the Health IT industry conceals as they rip off physicians and medical centers with overpriced, substandard crap. One should only read the lawsuit my university, Drexel, filed against its EMR supplier, Allscripts, for example. This document is public - ed.]

2. The bill is really a form of corporate welfare. The cost of acquiring a compliant medical records system is an unfunded mandate on private practitioners, and hence an unlegislated and unconstitutional tax. The benefits primarily accrue to the private partner [e.g., payors - ed.] in the public-private partnership, not to the general welfare.

[That is what the latest evidence points to - ed.]

3. There is no evidence that the bill will work as intended. It is assumed that HIT will improve quality or reduce costs, but there is much evidence to suggest that the opposite will occur.

[see my website and my many posts on HCRENEWAL for substantiation of that - ed.]

4. Mandating HIT amounts to regulating the practice of medicine. “Quality monitoring” of practitioners effectively dictates how medicine must be practiced to obtain a government-approval rating. Congress has neither the expertise nor the constitutional authority to direct the practice of medicine. It cannot delegate to government agencies or private organizations authority that it does not have.

[indeed, although businesspeople, IT personnel, and others don't have the expertise, either, but that doesn't seem to stop them from trying - ed.]

5. HIT is vulnerable to terrorism and disaster. Congress should make no law regarding the use of computerized medical records that does not require that all such records systems are EMP-hardened and have adequate backup electrical generating facilities (and stored fuel for same) to keep the system up (including air conditioning) for 60-90 days in the event of disruption of the electrical grid. Has there even been a study of the effect of a prolonged blackout on a hospital that is solely dependent on electronic records?

[yes - one I'm aware of - a few days - and it wasn't pretty - "Computer Crash — Lessons from a System Failure", NEJM, Volume 348:881-882, March 6, 2003. The Bay Pines, Florida VA Hospital's $450 million dollar CoreFLS debacle, while not an EMR system or blackout due to power failure per se, is another useful example, as chronic system issues disrupted the hospital's supply chain and prevented performance of surgery as a result - ed.]

-- SS

"Price Keeps Doctors From EMR's" - and Price Keeps Me From My Shiny New F22A Raptor

in the commendable article "Few Doctors Use Electronic Records Because of Costs", Bloomberg reporter Cristina Alesci reports on a Harvard University survey published in the New England Journal ("Electronic Health Records in Ambulatory Care — A National Survey of Physicians").

Its results summary states:

Financial barriers were viewed as having the greatest effect on decisions about the adoption of electronic health records.

The study is being widely interpreted to indicate the disappointing diffusion of the electronic medical record largely results from cost.

Yes, cost - that's all that keeps me from doing High-G Barrel Rolls and saving the planet in my shiny new, easy to install and operate, maintenance-free F22A Raptor.

This is the toy I just can't have because of cost.

Now, all we need is government "subsidies" to make this technology more "affordable!" Just the ticket to sap more of healthcare's precious, limited resources for the enrichment of the IT sector!

Oversimplifications and omissions of critical realities about health IT are not going to serve medicine and its practitioners well. The healthcare IT industry is one that doesn't know what it doesn't know, and doesn't seem to care that it doesn't know what it doesn't know. To the Moon in a Hot Air Balloon! (Hot air balloons go up. The moon is up. What's the problem? And balloons don't even cost that much!)

I really do love oversimplifcations! Especially when it involves the tool that's going to Revolutionize Medicine and let us Take Back the Future of Health Care, Cyberdyne's SkyNet -- oops -- er, the Electronic Medical Record system!

Now, if only the darn things would just somehow maybe come down in price, like oil, SHAZAM! - all medicine's problems would be solved!

I don't think so, and it case you didn't notice, I was being sarcastic. It comes after years of writing on the same topic and having responses known as the "bovine stare of incomprehension" (the look you get from a cow after explaining Einstein's General Theory of Relativity to the animal) and/or the "ostrich" response. (I am not even mentioning the ad hominem attack. Nope! Never happens over something as critical as healthcare IT!)

/Sarcasm off

/Serious mode on:

Back to the article. As I mentioned, in the excellent article "Few Doctors Use Electronic Records Because of Costs", Bloomberg reporter Cristina Alesci reports on a Harvard University survey published in the New England Journal. The survey found that:

Just 4 percent of doctors use software that includes electronic prescriptions and drug-interaction warnings. A larger group, 13 percent, opted for more basic software that only allowed them to enter notes and medical histories. Those who use the computer systems said they helped improve patient care.

I commend Ms. Alesci for her reporting of these figures to a national audience. Hopefully, the HIT industry won't do a Ross Koppel on her (Ross was attacked by those with industry interests, at one point having his research called "disingenuous" in print.)

Of course, she is reporting on what the experts are telling her, but not on what they're not telling her.

What say the experts? That some mysterious, unknown, unstoppable force out there that for the past 30+ years just keeps this miraculous, trouble-free technology from diffusing like the iPod. What in heavens' name could that unstoppable force be?

Cost!!

That's it. The technology just COSTS TOO DAMN MUCH! (Nobody EVER asks why. Here's the answer: because EMR's must be manufactured on computers made of solid platinum. That platinum is costly!)

Of course, other possible factors for the lack of EMR diffusion are simply Red Herrings and myths and opinions and anecdotes. Factors such as immaturity of the technology, bad design, unexpected adverse consequences, false assumptions, underestimations of difficulty, lack of understanding of sociotechnical issues that impair acceptance, unclear benefit and irrational exuberance over HIT, demands that clinicians use tools designed by business IT personnel who know nothing of medicine's "hiding in plain sight" complexities, designed and implemented via processes and methodologies best known for failure, produced by an industry rife with conflicts and deception, whose leaders often lack substantive credentials, produce ill-conceived and/or shoddy products whose use is mandated by non-clinician hospital managers and that several other Harvard physicians note in the NEJM here can impair medical practice and education.

I forgot to mention the exclusion from leadership of medical informatics professionals such as here , here , here , here , here , here , here , here and here where I wrote about difficulties these specialists seem to have in securing positions with a future : that is, leadership positions with true control of resources, career advancement opportunities into higher levels of healthcare management, and some degree of stability, instead of "director" or "C" level titles that in reality translate to “internal consultant” or "director of nothing."

Oh, and let's throw in the fact that "failure and de-installation of EHRs abound."

... a recently released survey of healthcare IT use conducted by the Boston-based Medical Records Institute found ... nearly 19% of respondents to [a] survey indicated they either have in the past experienced the de-installation of an EMR system (12%) or are now going through a de-installation (7%) ... Slightly more than 8% of those surveyed indicated they'd ripped out their EMRs and gone back to paper, with 6% indicating the uprooting occurred in the past, while another 2% responded that they were now experiencing the reversion to paper. In addition, 30% of respondents indicated they either have had an EMR in the past (12%) that not all clinicians used because some refused to do so, or that they now have a system (18%) and are experiencing the same recalcitrance by some clinicians [most often due to poor design and fit into real medical environments; physicians rarely refuse to use genuinly helpful technology, in fact they eagerly and sometimes cavalierly embrace it - ed].

Yes, let's just reduce the cost of this technology, and ... problem solved!

Nationalization of the HIT industry to reduce those pesky costs and move on with revolutionizing medicine, anyone? The government, after all, knows best!

-- SS

Afterthoughts:

• Of course, poor EMR diffusion is all doctors' fault.

• The F22A Raptor only costs about as much as a hospital EMR or two, a bargain at only $142 million! Guess those EMR vendors should also get into aerospace!
  

Outsourced to Death?

A while back, we posted frequently about the sudden toxicity of what used to be an apparently well understood drug. A summary of the story to date is below (in smaller type.):

- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.
- Then, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."
- The parties involved, including the US Congress, the US Food and Drug Administration, its Chinese counterpart, Baxter International, Scientific Protein Laboratories, blamed each other for the problems (see post here).

Since the beginning of May, the story has become surprisingly anechoic. Just recently, however, a brief, grim reminder appeared (e.g., by Bloomberg News, via the Boston Globe):

The blood thinner heparin has been linked to 149 US deaths in people who had allergic reactions after taking it, US regulators said.

The new tally, posted yesterday on the Food and Drug Administration's website, expands the toll of people who took the drug and suffered allergic reactions. The agency said in April it knew of 81 people who died after suffering allergic reactions from the drug, made from pig intestines.

But since early May, no more seems to be known about where the contaminant was introduced in the supply chain, who introduced it, or whether faulty oversight on the part of Baxter International or Scientific Protein Laboratories allowed the contamination to go undetected.

The mounting death toll from contaminated heparin suggests that the outsourcing of core functions of health care organizations may need to be rethought.

Thus, the recent discussion on the Managed Care Matters Blog, by Joe Paduda about the perils of brain-dead outsourcing seems particularly relevant. He first noted:

In the old days, companies tried to control as much of their raw materials - and the refining and transportation of those raw materials - as possible. In addition to auto plants Ford owned iron mines, steel mills, glass factories, rubber plantations, ships, and railroad cars. Nowadays Ford outsources some of its vehicles' key components (engines, transmissions, steering linkages) to other companies, concentrating on designing, assembling and marketing instead.

Over the last couple of decades, manufacturers found themselves increasingly relying on other companies for critical processes and components - if all worked well, profits zoomed, and if not, heads rolled.

But often this sort of outsourcing often breaks down

and when it does disaster often ensues

He had plenty of examples,

Sony buys LCD panels not on clarity and brightness but on cost, thinking hey, they are cheap so more folks can afford them - don't worry if the picture is lousy and colors muddy - in fact don't even look at the picture before you select a vendor.

Paduda cited the example of Compaq, once one of the major US makers of personal computers (and the first maker of a practical "lugable" computer.) Based on an interview with "disruptive technology" guru, Clayton Christensen, Paduda summarized how Compaq first outsourced some of the circuit boards in the computer, and saved money in the process. Then they outsourced the mother board, the main computer circuit board. Then they outsourced the design of the computer. As Christensen said, Compaq managers agreed, "our core competency is really our brand. We can fire all the engineers...." The result was, "the supplier in the Third World starts to eat their way up inside the customer, and every step forward they take progressively trivializes the remaining value Compaq adds, until in the end they're providing almost no value and the company vaporizes."

The key lesson here, which was not stated by Paduda or Christensen, is confusion about what an organization's core really is. The rationale for a company to outsource is that an outside organization may be able to provide non-core functions at a lower cost. Real problems arise, however, when managers seem to progressively decide that less and less of the organization's functions are core.

It may be that many managers seem to think that what they do is the only real core part of the organization, that is, that they, the managers, are the only indispensable part of the organization. It may be that many managers, trained as super-generalists, believe only they have the brilliance to manage any organization, even if they do not understand the context in which it operates, or the technical or scientific rationale of its products. Scientists, engineers, professionals, assembly line workers, service specialists to such managers are all superfluous. Of course, it may actually be harder to find specialized technical workers or professionals, or to set up complex manufacturing processes, than to find a few more self-proclaimed genius MBAs.

In my humble opinion, this kind of thinking has infected many health care managers. It may have contributed to the death of 149 people from out-sourced, contaminated heparin. More disasters are likely to ensue, and will keep happening until we reaffirm what the core of health care organizations really is.

It is dedicated health care professionals sworn to put patients' interests first. It is scientists who mean to discover the truth about biology and disease. It is the complex, often highly technical infrastructure that allows good care to happen for particular patients at the time it is needed, and the particularly qualified people who staff that infrastructure.

It is not managers who do not understand health care, medicine, or biology. It is not marketing. It is not accounting. It is not legal services. Maybe we have the outsourcing in health care all backwards.

MEDSCAPE'S CME ETHICS, PART II

19 June 2008

MEDSCAPE’S CME ETHICS, PART II

A few days ago I discussed Medscape’s parasitic use of professional organizations to embellish its mediocre CME offerings – “highlights” of the closed 2007 ACNP annual meeting, for example. One of the responses to my post called attention to Dr. George D. Lundberg’s video editorial of 13 June 2008, denouncing attacks on commercially sponsored CME activities. Among other claims, Dr. Lundberg, a past editor-in-chief of JAMA, stated that Medscape “follow(s) rules that prevent bias and improper influence.” He went on to boast that Medscape is “the largest single source of CE for health professionals” and that “We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent…. We welcome analysis and criticism. We function in the best interests of patients …” These words were spoken before Daniel Carlat and I published our critiques of Medscape a few days later (see here and here and here).

There seems to be a right hand – left hand problem at Medscape. Though I take Dr. Lundberg at his word about his intentions, I invite him to defend the products that actually appear under his oversight as editor-in-chief. Let’s look at a case study of an “Expert Interview” published on-line June 9, 2008 under the tagline Medscape Perspectives on the American Psychiatric Association (APA) 161st Annual Meeting, May 3-8, 2008, Washington, DC. A boilerplate legal disclaimer noted, “This activity is not sanctioned by, nor a part of, the American Psychiatric Association. Conference news does not receive grant support and is produced independently.”

The “Expert Interview” for our case study is titled “Pharmacologic Options for Treatment-Resistant Depression…” The featured expert is Charles Nemeroff, chairman of Emory University’s department of psychiatry. Dr. Nemeroff is well known for ethical controversy. In 2003 the Nature Publishing Group revised their policies on disclosure of financial conflicts of interest in the wake of Dr. Nemeroff’s widely publicized nondisclosures. In 2006 Dr. Nemeroff resigned as editor of the journal Neuropsychopharmacology after he failed to disclose conflicts pertinent to a review article he co-authored and placed in his own journal. As is always true of case studies, the devil is in the details if we wish to understand just how sly and subtle was the spinning. Here are some of the issues that arise from Dr. Nemeroff’s Expert Interview on Medscape.

1. Internal contradiction. The legal disclaimer noted above states that there was no grant support and that the conference news items were produced independently. However, Dr. Nemeroff’s featured item prominently acknowledges an unrestricted educational grant from Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. These two companies jointly market aripiprazole, a member of a drug class highlighted by Dr. Nemeroff in his Expert Interview.

2. Infomercial format. The Expert Interview by Dr. Nemeroff resembles nothing so much as Lindsay Wagner promoting the Select Comfort Sleep Number Bed in television advertisements. Promotional statements are made without scientific backup.

3. Disease mongering. In this interview, Dr. Nemeroff backed away from his earlier strict definition of treatment-resistant depression (TRD), proclaiming that in his current view 40% to 50% of depressed patients have treatment resistance. This sleight of hand naturally expands the market for the agents he later promotes as augmenting agents.

4. The primary care “hook.” Dr. Nemeroff introduced a professional “hook” to primary care physicians, emphasizing the association of depression with cardiovascular disease. This strategy is a component of disease mongering. Dr. Nemeroff’s discussion of this association had approximately zero educational value. Why did Medscape not insist on more substantive content?

5. Inappropriate drug recommendation. In discussing the switch strategy from one antidepressant class to another for resistant depression, Dr. Nemeroff included a recommendation for nefazodone. That drug was withdrawn by Bristol-Myers Squibb Company several years ago because of hepatic toxicity. What kind of “expert” makes such a recommendation? And what kind of editorial oversight by Medscape waves through such an incompetent statement?

6. Uncritical reliance on uncontrolled studies. In discussing switch of antidepressant drugs, Dr. Nemeroff noted that in phase II of the STAR*D trial 25% of patients switched from citalopram to sertraline responded. Dr. Nemeroff’s discussion of that result was inadequate. He invoked a dubiously relevant effect of sertraline on the dopamine transporter (when you are stuck for an answer, invoke neurochemical mythology) but he ignored the default hypothesis that 25% would have been the placebo response rate had STAR*D been designed to include placebo control groups. This default hypothesis assumes that all SSRI drugs are basically similar in terms of efficacy. For an educational item in Medscape or anywhere else, this aspect of the Expert Interview falls short of expected standards.

7. Pushing dangerous drugs. Dr. Nemeroff has been a leader in promoting use of second generation antipsychotic (SGA) drugs as augmenting agents for resistant depression. I have commented previously on his promotion of risperidone for this purpose, here and here. Others have raised serious questions about his reports. Overall, Dr. Nemeroff promotes these drugs by exaggerating their efficacy and glossing over their toxicity in resistant depression.

8. False statements. In this Expert Interview, Dr. Nemeroff leads off his discussion of SGA drugs for TRD with an endorsement of risperidone. The 2 published references to risperidone in TRD have major scientific flaws. Indeed, the study by Rapaport et al (reference 12 in this interview)was retracted. Nevertheless, Dr. Nemeroff still claims this study supports his position on SGA use in TRD. Does Dr. Nemeroff not read the retractions of his own publications (by his own “research team”)? How naïve are Medscape’s editors to be ignorant of these retractions?

9. Talking up the sponsor’s product. In reviewing the toxicity of SGA drugs for TRD, Dr. Nemeroff found something negative to say about the side effects of olanzapine, quetiapine, and risperidone. However, he made no mention of aripiprazole’s side effects, even though he emphasized its recent approval by the FDA for TRD. How convenient, as BMS-Otsuka sponsored his Medscape spot. Where were Medscape’s editors, described by George Lundberg as working to prevent bias and improper influence?

10. Glossing over weak efficacy. Though Dr. Nemeroff endorsed aripiprazole for TRD, he neglected to discuss the weak efficacy of this drug. The Number Needed to Treat for remission with aripiprazole in TRD is a disappointing 10. The studies cited by Dr. Nemeroff only compared aripiprazole against placebo. Dr. Nemeroff surely knows that just beating placebo does not qualify a drug as clinically useful. Dr. Nemeroff neglected to address the comparative efficacy of aripiprazole versus established treatments of TRD, such as lithium augmentation. The available evidence suggests that patients will do better on lithium and that aripiprazole would not be the first line choice, especially in primary care. Where were Medscape’s editors?

11. Reckless promotion of SGAs early in the course of TRD. Dr. Nemeroff emphatically stated he is not opposed to the early use of SGAs for TRD. Here especially he resembled Lindsay Wagner. A conscientious educator would weigh the risks and benefits of the early and broad use of SGA drugs in TRD. Dr. Nemeroff did no such thing. He simply opined. Why did Medscape’s editors allow him to get away with this reckless promotion? There does not appear to have been any effective editorial oversight of this publication.

12. For Dr. Nemeroff to promote early use of SGAs in TRD is reckless because of the serious toxicity associated with these drugs. Where is the discussion of akathisia (26% in the most recent study of aripiprazole in TRD)? Where is the discussion of emergent suicidality associated with akathisia in depression? Where is the discussion of tardive dyskinesia caused by aripiprazole (5% within 12 months in schizophrenia, and quite possibly higher in mood disordered patients)? Where is the discussion of neuroleptic malignant syndrome associated with SGAs like aripiprazole? Where is the discussion of weight gain with aripiprazole in TRD (significantly greater than with placebo)? Where is the overall analysis of risk versus benefit? Where were Medscape’s editors? Who at Medscape was looking out for “the best interests of patients”?

13. Incomplete disclosures. Dr. Nemeroff has a long history of recidivism concerning failure to disclose pertinent financial conflicts of interest. His record in this instance continues that sordid tradition. He failed to disclose that he is currently chairing a national series of CME meetings promoting aripiprazole for TRD, sponsored by, you guessed it, Bristol-Myers Squibb/Otsuka. Perhaps he thinks that because the money is laundered through a Medical Education Communications Company he doesn’t need to disclose it. Tell that to Joseph Biederman, who was called to task last week by Senator Grassley’s Senate Finance Committee for exactly that obfuscation. Dr. Nemeroff also failed to disclose his support from Janssen for studying risperidone in TRD. He failed to disclose his association with CeNeRx, that is developing MAO inhibitors, mentioned favorably in his interview. There is more, but these examples will suffice. Doesn’t Medscape know by now that Dr. Nemeroff cannot be relied on to report his conflicts appropriately? Does Medscape have knowledgeable professionals or ciphers in its editorial office?

So, this sleazy example illustrates many of the systemic problems that Medscape will need to correct if it hopes to remain credible. This documentation gives the lie to Dr. Lundberg’s claims that “We are clean. Our work is transparent.” One suggestion is for Medscape to abandon the degenerate form of scientific journalism exemplified by “Expert Interviews” and News items. In their present formats they cannot be truly educational and balanced items. They do not qualify for CME credit, as I verified with the company. They are simply vehicles for promoting sponsors’ products. And the Medscape staff seem to think their job is to ensure that the spin is firmly in place. Does George Lundberg really intend that?

"Oppressive" Management at UTMB

The Houston Chronicle reported about troubles at the University of Texas Medical Branch (UTMB) School of Nursing:

Discontent among nursing school faculty at the University of Texas Medical Branch at Galveston runs so deep that it hinders the ability to train nurses, a statewide faculty association says.

Experienced faculty members are seeking new jobs because of an oppressive administration that has jettisoned the traditional academic system ensuring academic freedom, according to interviews with faculty members. The administration, they say, has embraced a corporate model emphasizing income and loyalty.

The oppressive management style is fostering discontent not only in the nursing school, but throughout the university, including its medical programs, [Texas Faculty Association representative George] Reamy said.

Things got particularly tense after the termination of a popular administrator.

The faculty association had long complained about the steady loss of faculty and increasing teaching loads that left little time for research. The simmering discontent came to a boil when [Dean Pamela G] Watson refused to renew the contract of Associate Dean Kathy Lucke.

Lucke was popular among the faculty in part because she was seen as sympathetic to their plight, faculty members said.

In response to Lucke's involuntary termination, 39 faculty members signed a petition that said, 'We are distressed that she has been relieved of her position and have concerns for the future of the school and its ability to maintain the excellence in nursing education it currently holds.'

An accompanying letter outlined faculty concerns and listed the names of 34 staff lost during Watson's six years in office and four others who intend to leave.

The administration did not respond with sympathy.

The administration responded with an iron fist, [Texas Faculty Association representative George] Reamy said. He said [Executive Vice President and Provost Dr Garland D] Anderson accused the faculty of trying to get the nursing school dean fired and told them to stop complaining or resign.

The administration also refused to respond to the Chronicle's reporter.

UTMB denied a request by the Houston Chronicle to interview President Dr. David Callendar, hired less than a year ago; Provost and Executive Vice President Dr. Garland Anderson; and school of nursing Dean Pamela Watson.

UTMB spokesman John Koloen said, 'It is university practice not to comment on personnel matters.' Koloen said officials also would not comment on nonpersonnel matters associated with the association's complaints.

Add this to our series about mission-hostile management of academic health care institutions. (Other recent examples were in posts were about the JPS Health Network and the University of Arizona.) Of course, sadly, academic administration run on the corporate model is getting to be an old story. And see the FIRE (Foundation for Individual Rights in Education) web-site for a distressing catalog of offenses by academic administrators (and sometimes faculty) against free speech and academic freedom. An academic institution ought to welcome open discussion and debate about the direction of the institution. Actually, a well run corporation should also welcome such discussion and debate. An academic manager who tells experienced faculty members who voice criticism to shut up or quit is a manager who has no idea what to do next.

Irresponsible Optimism on Health IT? Pharma should demand the same treatment ...

Imagine a government report about pharma that glosses over the rough edges. Imagine a report where the most critical issues in pharma are reluctant doctors, difficulty measuring ROI of drugs, and the criteria for the quality of drugs being solely dependent on whether users take them correctly.

Well, no such pharma report exists (the opposite is true - pharma is put under a microscope and excoriated harshly by the government, media, activist groups, etc. for even the slightest "deviation"), but in Health IT, it is a different matter. Optimism and idealism prevail at a level that might be considered irresponsible considering the known risks of HIT difficulties and failure. Such costs represent capital and resources healthcare simply cannot afford to waste.

In the milquetoast May 2008 report "Evidence on the Costs and Benefits of Health Information Technology" (PDF), the Congressional Budget Office essentially whitewashes the downsides and difficulties of Health IT. Most of the potential benefits (largely as yet unrealized after 30+ years of continued, unabated efforts and optimism) are laid out, but none of the drawbacks - the expensive project difficulties and failures, the unexpected complications, the cost overruns, the de-installation of systems, etc. are covered in any substantive manner or even mentioned.

It is difficult to believe such material was unavailable or unknown to the analysts who produced this report. It is quite likely they simply ignored it.

Why might this occur?

A clue is in the preface:

Stuart Hagen of CBO’s Health and Human Resources Division and Peter Richmond, formerly of CBO, prepared the report under the supervision of Bruce Vavrichek and James Baumgardner. Keisuke Nakagawa provided able research assistance. The report benefited from comments by Tom Bradley, Robert Dennis, Keith Fontenot, Holly Harvey, David Moore,Robert Nguyen, Allison Percy, William Randolph, and Philip Webre, all of CBO.

In addition, several briefings organized by the Health Information Management Systems Society provided helpful data. A number of outside reviewers also provided comments: Laura Adams of the Rhode Island Quality Institute, Mark Leavitt of the Certification Commission for Health Information Technology, David Cutler of Harvard University, Richard Hillestad of the RAND Corporation, and Douglas Johnston and Eric Pan of the Center for Information Technology Leadership.

It seems many of the outside consultants to the report may have a vested interest in the unfettered diffusion of clinical information technology.

That is, unfettered by any concerns about the immaturity of the technology, unexpected adverse consequences, false assumptions, underestimations of difficulty, lack of understanding of sociotechnical issues that impair acceptance, out of control technology costs ($100 million for an EMR?), unclear benefit and irrational exuberance over HIT, demands that clinicians use tools designed by business IT personnel, designed and implemented via processes and methodologies best known for failure, produced by an industry rife with conflicts, whose leaders often lack substantive credentials, produce ill-conceived and/or shoddy products whose use is mandated by non-clinician hospital managers and that several Harvard physicians note in the NEJM here can impair medical practice and education.

Not to mention a rather short supply of greenbacks laying around in the halls of healthcare for IT misadventure.

In other words, just minor concerns.

Not even the pharmaceutical industry with the powerful Pharmaceutical Research and Manufacturing Association PhRMA (perhaps one of the largest and most influential lobbying organizations) receives such deference.

Maybe the pharma industry should demand the same almost-scandalously and willfully blind, superficial treatment that is accorded to the health IT industry.

-- SS