Why is the New England Journal of Medicine Scolding "Pharmascolds"?

I, a normally quiet blogger on this site, was disquieted by what may be a backlash aimed at quashing the anti-conflict-of-interest movement.

Lisa Rosenbaum just published her second of three treatises in the highly prestigious New England Journal of Medine, scolding "pharmascolds" (see Conflicts of Interest: Understanding Bias — The Case for Careful Study). "Pharmascolds" is the term Rosenbaum and others use for those of us at Health Care Renewal, the Institute of Medicine, and countless medical journals and institutions.  Why?  Because we dare assert there is great danger when providers practice though saddled by (potential) conflicts of interests in medicine.  Such conflicts are created when physicians (up to 94% of us, according to Rosenbaum's research), other health care providers in practice, and health care organizations accept, not only gifts and trinkets, but also large, sometimes clandestine consulting fees and other arrangements from pharma and device companies, all the while providing direct patient care using the companies' products.

Rosenbaum and others say we pharmascolds are essentially self-righteous and obstructionist, holding back the progress of medical science.  In this article, she seems to claim that not proving direct patient harm from a specific questionable financial arrangement with a company whose product we may therefore more likely prescribe, speak well of, or publish (pseudo)evidence supporting the use of, is enough of a reason to justify the arrangement. 

Wouldn't that be the same as saying, "Until you actually crash into another car while texting, it's ok to text while driving, even if it's distracting."?

Rosenbaum uses mainly anecdote to prove her point, and appeals to a little-quoted, but still important, heuristic/bias called "moral liscensing."  Rosenbaum describes the phenomenon correctly: "once disclosure [of a conflict of interest] gets the weight [of guilt] off your chest, you feel liberated and may feel licensed to behave immorally."  True.  But then Rosenbaum seems to support non-disclosure of acts that create conflicts of interest, because disclosure doesn't decrease the acts themselves.

Rosenbaum goes further. At the same time as she supports non-disclosure of conflicts, she attempts to paint those who accept conflict-generating arrangements and keep them clandestine as victims--afraid to "come out of the closet" because doing so is socially taboo, though the activity is not wrong. 

I beg to differ.  For certain acts, potential conflicts, and actual conflicts, it seems to me that mere disclosure of the act or conflict shouldn't relieve one of the guilt associated with the act or conflict.  It also seems disclosure of a conflict should not make a speaker seem more credible to his/her audience because of its disclosure, though some research Rosenbaum quotes seems to show that disclosure improves credibility. 

Perhaps the stronger argument for disclosure is to disqualify people from activities that should be prohibited for people in conflict, as well as to warn people away from engaging in questionable activities that would result in conflicts. 

In an unbelievable twist of logic, Rosenbaum seems to be arguing in this article for more, not less of these questionable activities, in the interest of advancing science, until we prove patients are directly hurt by them, i.e., we have a "wreck."  Heck, let's get rid of traffic lights too, while we're at it.  People have eyes. We should trust them. They should be able to avoid accidents voluntarily, on their own.

In short, how could Dr. Rosenbaum not see that the best solution for the "problem" of conflicts of interests is avoidance when possible?  One can't help but wonder if she and the Journal aren't blinded by the shimmer and pull of powerful, influential organizations, ones so shiny, so strong, and so ubiquitous that resistance is just too hard for her, the Journal, and for 94% of us.

Conflicts of interest should be avoided.  Society has accepted that improved health will result not just from secondary prevention (e.g., not texting while driving after one has had an accident from the activity), but also from primary prevention (not texting while driving, even before an accident occurs). 

Wally R. Smith, MD

1:59 PM

Insurers' diversification creating monopoly power and conflict of interest - quoted in the Washington Post

I am quoted in a Washington Post article today on potential conflicts of interest when medical payers/insurers acquire the firms that hospitals and doctors use to challenge medical payment denials:

 "Health insurers’ push to diversify raises ethical concerns"

Washington Post
Jay Hancock, Sunday, April 29

Like hospitals and doctors everywhere, Banner Health fights a daily battle to get paid by insurance companies and government agencies for the care it delivers.  So the hospital system hired a company called Executive Health Resources to fight back against the likes of Medicare and UnitedHealthcare when they deny claims or pay bills for less than what Banner thinks it is owed.

Fair enough.

But Banner executives began to worry about EHR’s independence when the firm was acquired in 2010 by UnitedHealth Group, UnitedHealthcare’s parent.

Issues can get a bit sticky under such an arrangement.

I put it this way:

Critics call United’s ownership of EHR a troubling conflict of interest that could give it confidential information about rivals as well as patients and limit EHR’s power to demand payment from its much larger corporate sister. “How is that ownership going to affect the mission of a company whose business is to extract more money from payers?” said Scot Silverstein, a physician and specialist in medical software and patient records at Drexel University. “Imagine going to a plaintiff’s lawyer to take your malpractice case and not knowing that plaintiff’s lawyer actually works for the hospital that you’re suing.”

When payers acquire those who would challenge their payment denials, I worry about the consolidation of power being too great for the public good.

As we learn, the relationship is somewhat stealthy:

... There is no mention of EHR’s ownership in the “Corporate Overview” section of its Web site or elsewhere on the site. Nor did the American Hospital Association identify EHR as a United subsidiary in September when it renewed its exclusive endorsement of EHR’s denial-fighting services. EHR pays the hospital association a fee for the endorsement. The group declined to disclose the amount. 

The plot thickens:

Claims consultants such as EHR typically gain access to millions of patient records and confidential contracts between hospitals and insurers, industry officials say. If UnitedHealthcare, United’s insurance wing, gained access to that data, it would obtain “a huge business advantage” over insurance rivals as well as the hospitals, Kofman said.

In today's healthcare business environment, "if" seems to me to be optimistic.

Hancock goes further in the article:

As insurers eager to add revenue streams convert themselves into diversified health-services companies, they often buy traditional business adversaries, including physician groups and hospital consultants such as EHR. They’re also buying technology companies and research firms that serve medical-care providers, raising questions not only about independence but about the privacy of patient information.

A Georgetown professor, formerly a state insurance superintendent, gets to the heart of the matter, using United as but one example:

“I am not convinced that, even with proper disclosure, that an entity owned by United could aggressively advocate against United’s interests,” said Mila Kofman, a Georgetown professor who was Maine’s insurance superintendent.

This factoid is eye-opening:

Appealing claims denials has become a huge, high-tech business, reflected in the more than $1 billion that United reportedly paid for EHR [Executive Health Resources].

You might think there were better things to do with $1 billion besides administrative bloat - such as taking care of patients.

We probably need new laws to catch up with the flurry of M&A's going on in healthcare between payers, the healthcare delivery sector, and the "referees" that mediate between them when disputes arise.

Read the entire article at the WaPo link above.  The examples get even more convoluted.

-- SS

Addendum:

Roy Poses notes:

This appears to be a newly recognized type of conflict of interest that contributes to the concentration of power in the US commercialized health care system.  While many people tout how our health care system is "competitive" and a "free market," it is ever more dominated by a decreasing number of enlarging organizations.  True health care reform would break up health care oligopolies.

-- SS

2:29 PM

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF?

Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously described, Stossel is planning the inaugural meeting next week of a group to counter those he calls pharmascolds. The group is named ACRE – Association of Clinical Researchers and Educators. Here is its website: http://www.acreonline.org/ For months, Stossel has been warning of the dire negative consequences that will result from tightened conflict of interest policies, but he has not presented any persuasive examples of damage to “productive relationships between industry and physicians involved in clinical research and educational outreach.” At the same time, Dr. Stossel has conveniently overlooked the shenanigans of the bad actors whom Senator Grassley exposed. Dr. Stossel is a blowhard, as I have described here before.

But wait! ACRE has found something! A News item in the July 2009 issue of Nature Medicine (“Conflict of interest rules seen by some as too stringent”) quoted one of the participants in the upcoming ACRE conference. Avi Markowitz, chief of oncology at UT Medical Branch, Galveston, came up with this example: Patients taking a Sanofi Aventis chemotherapy product may experience peripheral neuropathy, which can cause unpleasant sensations in the hands and feet. ‘Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now, Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.’ Reading between the lines, it is a good bet that these items originally were branded.

Whatever. And never mind that the patients receiving chemotherapy at UTMB are doubtless billed a hefty facility fee that must include comfort items like blankets and gloves. Since when does a chief of oncology need to beg for these basic patient care provisions from drug companies?

Is this all that ACRE can come up with? The ACRE homepage warned sternly of “restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.” Does Thomas Stossel’s whining and catastrophizing through ACRE come down to piffling items like blankets and gloves for chemotherapy patients? That’s it? Where’s the beef?

At least ACRE has the good sense not to include on its program the smooth operators whom Senator Grassley outed – like Nemeroff at Emory, Schatzberg at Stanford, Kuklo at Walter Reed, Keller at Brown, Biederman at Harvard. Not even Stossel has been brazen enough to try to defend them.

The Nature Medicine News item does close on a helpful note: 'Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.' I say Amen to that, even if it is a day late and a dollar short.

We have arrived at our present state of discomfiture because the leaders of academic institutions and professional societies looked the other way for too long. They failed to do their job of reining in the ethical outliers. Grassley had to do it for them. As a result, the rest of us will be burdened with new regulations for years to come. Those who did speak up years ago were ignored or demonized. As the saying goes, every group gets the leadership it deserves. Those in academic medicine had better not count on Stossel and ACRE to lead them out of the wilderness.

Bernard Carroll.

2:30 PM

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, No. 3934, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the industry-founded and connected group "Certification Commission for Healthcare Information Technology" (CCHIT). The Bill calls for monetary civil penalties for such sale or use:

A civil penalty or civil fine is a term used to describe when a state entity or a governmental agency seeks monetary relief against an individual as restitution for wrongdoing by the individual.

I previously wrote about CCHIT in a series of linked posts that start here: A very troubling post about the CCHIT (Certification Commission for Healthcare Information Technology).

I have now written the following open letter to Mark Leavitt, MD, PhD, Chairman, Certification Commission for Healthcare Information Technology.

To: "Mark Leavitt"
Date: Sunday, June 07, 2009 02:10PM
Cc: Robert O'Harrow, Jr., Washington Post, and various AMIA working group mailing lists (CIS - clinical info systems, POI - people & organizational issues, OS - Open Source, and ELSI - Ethics, Legal & Social Issues)

June 7, 2009

Mark Leavitt, MD, PhD
Chairman, Certification Commission for Healthcare Information Technology
www.cchit.org
[6/8/09 - contact info from www.markleavitt.com removed per critique in response below -ed.]

Re: NJ HIT Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17

Dear Mark,

The NJ Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17, calls for making it a violation of law to sell HIT not "certified" by CCHIT . Penalties are called for. The bill states:

... No person or entity, either directly or indirectly, shall sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by the Certification Commission for Healthcare Information Technology.

As used in this section, "health information technology product" means a system, program, application, or other product that is based upon technology which is used to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information.

b. A person or entity that violates the provisions of subsection a. of this section shall be liable to a civil penalty of not less than $1,000 for the first violation, not less than $2,500 for the second violation, and $5,000 for the third and each subsequent violation, to be collected pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

I and others find this bill remarkable. It really calls into focus the HIT community's concerns about CCHIT and its political connections, especially pursuant to the article " The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records " of May 16, 2009 in the Washington Post by Robert O'Harrow Jr.

I therefore seek answers to the following questions:

1. Do you approve of the proposals in the bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM ?

2. Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

3. Did anyone with governance or leadership roles in CCHIT's founding or affiliated organizations (e.g,, HIMSS, CITL, and others) or business associates of such people, play a role in the bill's sponsorhip, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

4. Did anyone (person or company) in the HIT industry, broadly speaking, who could directly profit from such a bill becoming law play a role in sponsorhip of, or advocacy for this bill?

I believe candid and transparent answers to these questions are important in giving the HIT community confidence that CCHIT primarily serves the public interest, not interests of an HIT lobby.

-- SS

6/8/09

Dr. Leavitt has candidly responded. I take his word on these issues at face value, having done business with him a bit over a decade ago (supporting the purchase of his company's EHR, Logician, for Christiana Care over the opposition of the IT department which preferred another vendor):

From: "Mark Leavitt"
Date: 06/08/2009 02:51AM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Scot,

Here are the answers to your questions:

1. No, I do not approve of this legislation -- which I'm reading for the first time in your email. Our goal, stated in almost every presentation I've given, and to which I've adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. The bill does not fit that model at all, and it is a bad idea.

2. Neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings.

3. Trustees, Commissioners, and Work Group members serve in a volunteer capacity at CCHIT. We require disclosure of conflicts of interest, but we do not monitor all activities in their 'day jobs' or other volunteer roles. "HIMSS, CITL, etc" are not affiliated with CCHIT, and we don't know about all their advocacy activities. I'm not privy to the information you seek.

4. This question presumes that I would know everything that "anyone in the HIT industry, broadly speaking" has done regarding the bill. Naturally I do not have that knowledge either.

Now that I've responded, the AMIA listserve members can stop reading here, while I go on to chat with Scot.

Scot, in 15 years of medical training and practice followed by 25 years of healthcare informatics, I've encountered very few people -- and certainly no university professors -- who acted so disrespectfully toward me. Being a veteran of health IT, it's easy to find people who have worked with me or know me well, and to ask them about my integrity. Or to talk to some of the other 50 or so Commissioners who've served or the hundreds of work group volunteers. Shouldn't an informatics scientist do a modicum of research before undertaking a potentially harmful procedure such as attacking a person's or organization's reputation? Reading a news article by Mr O'Harrow does not qualify as due diligence. Would you let your informatics students get away with that before recommending a major, potentially disruptive or destructive IT project?

From your own blogging I see that your "early medical mentor, cardiothoracic surgery pioneer Victor P Satinsky, MD, believed in public embarrassment as a tool to fight bureaucracy and discrimination ." Well, that helps me understand. And your blogging about your frustration when you sought employment with a commercial EHR vendor http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html explains even more. Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. I would be pleased to engage in a civil, rational debate with you along the lines of "EHRs -- do the benefits outweigh the risks?" C'mon out to the farm here sometime -- you know the address, and the dog's friendly -- or we could do it on the web.

Finally, my apologies to everyone on the mailing lists that Dr. Silverstein chose to include in his investigative journalism broadcast. If you object to his use of AMIA mailing lists for this kind of activity, you could let him know.

Mark Leavitt, MD, PhD
Chairman, CCHIT

My response was simple:

To: "Mark Leavitt"
Date: 06/08/2009 05:24PM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Mark,

I thank you for the answers to my questions.

> Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists.

Mark, that information came from your page at http://www.markleavitt.com/ which I found on a google seach for "Mark Leavitt." Image attached. I believed that to be your professional contact info.

As to the rest of your response, you appear to attempt to discredit my arguments through ad hominem. I refer you to this page:

http://www.nizkor.org/features/fallacies/ad-hominem.html

Translated from Latin to English , "Ad Hominem" means "against the man " or "against the person."

An Ad Hominem is a general category of fallacies in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making the claim , her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim ). Second, this attack is taken to be evidence against the claim or argument the person in question is making (or presenting). This type of "argument" has the following form:

1. Person A makes claim X.
2. Person B makes an attack on person A.
3. Therefore A's claim is false.

The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of the claim being made (or the quality of the argument being made).

Ad hominem, sadly, is not debate.

Neither is appeal to authority .

Scot

Truth be told, I actually offered no arguments in my email message. I was asking very probing questions with concern they would be ignored, or responded to with "spin" as here, and their tone offended him. Fair enough.

I was a bit disappointed, however, by the "The lady doth protest too much, methinks" ad hominem embellishments to an otherwise candid and convincing response.

Such are the risks of directness and disruptive innovation, however.

-- SS

6/9 Addendum:

Additional views on the NJ Bill are at ePatients.net at "David Kibbe & Mark Leavitt:Openness vs. Opacity" and "Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?". There are some now-familiar themes regarding CCHIT civility in those posts.

6/10 Addendum:

As a result of a link sent by a commenter, I am adding the post "The Kibbe/Leavitt Rumble in the High Tech Jungle!" to the list of interesting views in the 6/9 addendum above.

11:11 AM

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a report of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times today calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.”

It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations.

First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.

Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.

As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH.

Recommendation 4.1 One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language:

“Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).

Last year I posted several times about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only “recruiting subjects; obtaining informed consent; assessing the clinical end points;” but also “analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.” (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets.

When Stanford adopts the IOM recommendations, such activities will be blocked. As I stated last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”

We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations.

Bernard Carroll.

UPDATE 04-30-2009: The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.

http://www.nap.edu/catalog.php?record_id=12598

5:40 PM

Does Pharma Want its Researchers to Believe They Are Next to God?

In "Drug Maker Told Studies Would Aid It, Papers Say" (New York Times, Mar. 19, 2009), the Times discusses the case of psychiatrist Dr. Joseph Biederman. Dr. Biederman outlined plans to test Johnson & Johnson’s drugs including risperidone/Risperidal in presentations to company executives and seemed to guarantee positive outcomes for his studies of the drug, raising questions about his research.

Biederman has become a key witness in a series of lawsuits filed by state attorneys general claiming that makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines. His work helped fuel a rapid rise in the use of these medicines in children. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but about $200,000 of this income to university officials.

However, if a passage about Dr. Biederman's testimony in court is correct, I believe pharma should consider whether it wants to use someone who believes they are next to God in any capacity whatsoever.

There are certain damning statements that, once made by a person, cast a deep shadow over a person's character. I believe this one, if true, may rise to that level:

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.

“What’s after that?” asked a lawyer, Fletch Trammell.

“God,” Dr. Biederman responded.

“Did you say God?” Mr. Trammell asked.

“Yeah,” Dr. Biederman said.

One does not usually joke in deposition.

I've been Yale faculty, and would never, ever have made anything even approaching such a comment, least of all in a deposition about drug issues affecting kids.

Let alone the the palm-greasing he was afforded, could Dr. Biederman's apparently hyperinflated ego have clouded his judgment and scientific objectivity?

In drug R&D, that is inherently an extremely dangerous proposition.

Where children are concerned, catastrophic might be a more apt term.

-- SS

4:11 AM