Helen Mayberg: A case study in why we need greater transparency about conflicts of interest

A year ago, the Department of Health and Human Services proposed new rules governing the disclosure and handling of financial conflicts of interest by medical researchers who receive federal funding. The more stringent rules were prompted by Congressional findings that prominent NIH-funded researchers had failed to disclose significant consulting and other income, violating the agency's own regulations. The new rules would, among other things, require universities to post on a publicly available website information describing the specific financial conflict of interests of their federally funded researchers, according to Sheldon Krimsky, the Tufts University ethicist who wrote about the new rules in an article for Ethics in Biology, Engineering & Medicine last year.

Why is this so important? Because the current system of disclosure has proven woefully inadequate in providing consumers with information about financial conflicts that can skew medical research and adversely affect patient care. According to a 2008 Inspector General's report, the vast majority (93 percent) of institutions reporting conflicts of interest to the NIH did not describe the nature of their researchers' conflicts; in addition, 90 percent of the universities relied solely on the researchers' discretion in reporting conflicts, which is why there was so much failure to disclose in the first place.

Here's an interesting case in point. Dr. Helen Mayberg, a neurologist at Emory University School of Medicine, has testified in more than 50 death penalty cases, always for the prosecution in an attempt to discredit any mitigating evidence of brain damage in defendants on death row. Indeed, in a 2009 transcript (State of Connecticut vs Richard Roszkowski), Mayberg acknowledged that she has probably testified exclusively for the prosecution in more recent death penalty cases than any other doctor in the country, except perhaps Park Dietz, known by some as Dr. Death for his decades of testifying on behalf of the prosecution in high-profile cases.

While Emory officials say Mayberg has reported her expert witness work to them, they are under no obligation to disclose the full range of her extra-curricular activities to the public under existing federal rules. As a result, very few of Mayberg's colleagues or patients know of her extensive testimony in death penalty cases. And Mayberg goes to some lengths to keep her lucrative sideline out of the public eye.

For example, she had a friend (David Dobbs)* scrub her Wikipedia page of any reference to her death penalty work or her previous failures to disclose other conflicts of interest; here's a more comprehensive earlier version of her wikipedia page pre-scrubbing. I blogged here about Mayberg's collaboration with former psychiatry kingpin Charles Nemeroff and her previous failure to fully disclose conflicts of interest involving her work with deep brain stimulation, a controversial technique for treating depression.

Also missing from Wikipedia is the fact that she has so angered other neurologists with her death penalty testimony that they tried to get her drummed out of the American Neuropsychiatric Association. As one prominent neurologist says, it's not just that Mayberg always testifies for the prosecution in death penalty cases -- in effect, "trying to kill people" -- but that she goes to considerable lengths to rebut defense experts, often introducing inaccurate information and contradicting herself in the process.

"She uses a lot of maneuvers to say that [defense] findings in brain scans are not valid, yet at the same time, she's written articles saying the brain scans are valid," says the neurologist in the Washington, D.C. area who has written extensively about brain damage. "In fact, she uses the same brain scans that she says are invalid in the courtroom to diagnose depression in people whom she then treats with deep brain stimulation."

According to Krimsky, Mayberg's death penalty work is considered a significant financial conflict of interest under both the old and new NIH rules. And if the new rules are adopted, she would not only be forced to disclose the extent of her death penalty work but also the money she makes from it. According to lawyers who do for this kind of work, Mayberg makes as much as $500 an hour testifying for the prosecution in death penalty cases. And since she travels all over the country to testify, including to notorious death penalty states like Texas and Alabama, those hefty hourly fees add up.

In response to my query about how many death penalty cases Mayberg has disclosed since she came to Emory in 2004 and how much money she's made from this sideline, all Emory officials would tell me is that "she reported five instances of expert witness activity in 2009." You do the math.

*Correction: David Dobbs did not scrub Mayberg's wikipedia page; he merely added a link to a feature he had written about her for the New York Times magazine.

A lesson in how not to run for public office -- in Canada or anywhere else

In his latest blog, Paul Thacker, an investigator for the Project on Government Oversight (POGO) and former aide to Senator Charles Grassley, struggles to understand how Dr. Stan Kutcher, a psychiatrist turned politician in Canada, could possibly say that Paxil study 329, which Kutcher co-authored in 2001, hasn’t caused any particular controversy. Thacker was at a conference in Toronto the night of the Canadian federal elections, and the talk at dinner that evening was all about how Kutcher, who was running on the Liberal Party ticket, had threatened to sue a Halifax newspaper, The Coast, for writing an article about his involvement in study 329.

In his blog, Thacker goes over ground covered in Side Effects -- how flawed the 2001 Paxil study is, how it was ghost-written by a medical contractor for GlaxoSmithKline, the maker of Paxil, and then signed off on by its many authors, including Dr. Martin Keller, the principal investigator from Brown University, and Stan Kutcher. Thacker notes that Side Effects isn’t the only detailed account of ethically questionable behavior in study 329. The BBC also ran an investigative report on its flaws, and several medical researchers have called for a retraction of the study; see here and here.

Rather than own up to his involvement in what many consider a mockery of empirical research, Kutcher threatened to sue The Coast for libel, forcing it to issue a retraction and remove the offending article from its website (it was promptly archived by another site, Scribd). And then, as Thacker and other bloggers note, Kutcher and his henchmen went on the attack and essentially accused me of being a Scientologist.

For the record, I am not and have never been a Scientologist. The more pertinent question is: does Canada want politicians who engage in these kind of ad hominen attacks? Apparently not.

Paxil study author and psychiatrist turned politician loses Halifax election

Stan Kutcher, the psychiatrist turned politician who threatened to sue The Coast newspaper in Halifax unless it issued a retraction on a story it did about Kutcher's involvement with Paxil study 329 (see retracted story here) and my blog about it), lost yesterday's election, along with the rest of his Liberal Party. See story here.

Halifax newspaper buckles under to threat from psychiatrist turned politician

In recent years, experts (like Bill Kovach and Tom Rosenstiel) have warned that press freedoms are under increasing threat from economic pressures. As advertising and readers flee to the Web, they say, news outlets are more likely to cave in to pressure from corporate and political interests. Here's a disturbing example of this trend.

A few weeks ago, I was interviewed by a reporter for The Coast newspaper in Halifax, Nova Scotia. The reporter, Tim Bousquet, had discovered that the Liberal Party candidate in Halifax for the upcoming federal elections, Dr. Stan Kutcher, was one of the co-authors of Paxil study 329, a controversial clinical trial on the use of Paxil in treating depression in adolescent. When it was first published in 2001, study 329 purported to show that Paxil was safe and effective when in fact the actual data showed the opposite, as I reported in Side Effects and subsequent blogs. What New York prosecutors, several researchers and I found was that the study's authors manipulated and omitted data to make Paxil look safer and more effective in adolescents than it really was -- see background here. Given the study's serious flaws, researchers Jon Jureidini and Leemon McHenry recently called on the Journal of the American Academy of Child and Adolescent Psychiatry to retract the 2001 paper, according to the British Medical Journal.

Last Thursday, five days before the Halifax elections, which are being held May 2, Bousquet posted this article about Kutcher's involvement in study 329. Bousquet quoted me as saying that the researchers "essentially distorted the outcome measures." He also quoted Kutcher as saying that he stood by study 329 and didn't think it had caused any particular controversy. I thought the article was accurate except for two facts the reporter got wrong: he said that a secretary at Brown had leaked the information to me in 2003, when in fact the person who first blew the whistle on study 329 was the assistant research director in the department of psychiatry at Brown, and she first made me aware of some of study 329's flaws in 1996. As I explain in Side Effects, I was unable to pin down those particular allegations until 2004, when the New York State Attorney General's office sued GlaxoSmithKline for defrauding consumers by not telling them or doctors the full story about Paxil. In their lawsuit, the New York prosecutors found numerous flaws in the study 329, including the fact that the researchers had changed the primary outcome measures for the trial without disclosing that fact in the published paper. They also found that GlaxoSmithKline knew that the study 329's results were negative -- i.e. -- that the clinical trial didn't find Paxil more effective than placebo in treating depression -- but according to an internal memo, company officials decided to publish the study as a positive result anyway and indeed had it ghost-written by a medical contractor and then signed off on by all the co-authors, including Kutcher.

Kutcher's lawyers immediate responded to Bousquet's April 28 article by threatening to sue the newspaper for libel unless it immediately issued a retraction. Even though Bousquet backed up his article's assertions with documentation, the Coast decided to issue an apology and retraction anyway; see here. And then the newspaper simply removed the original article from its website; see here. So now readers of The Coast can see the apology but not why it was issued in the first place. Fortunately, a website called Scribd saved Bousquet's original piece along with a follow-up article about Kutcher's threat to sue The Coast if it didn't retract the piece.

As you can see from Scribd's follow-up piece, a blog here, and some comments on the original article (all of which were removed), Kutcher's hatchetmen are trying to paint me as a Scientologist in an effort to discredit me and the original story. That's a tactic as old as dirt; as a mental health reporter for The Boston Globe in the '80s and '90s, I remember when the drug industry and the psychiatrists on its payroll used that ridiculous canard to attack anyone who questioned their wonder drugs; indeed, in Side Effects, I write about how Eli Lilly, among others, attacked Dr. Martin Teicher, a respected psychiatric researcher at McLean Hospital, as a Scientologist when he first raised questions about the safety of Prozac in the early '90s.

All of this makes me wonder: where have The Coast and its editors been all these years? And do they really want to go down in history as an example of the not-so-free press buckling under to craven threats?