Monday, November 15, 2010

Emory neurologist has history of failing to disclose conflicts of interest

My blog last week on Helen Mayberg's talk at the 2010 ScienceWriters conference caused quite a stir. Paul Raeburn, writing in the Knight Science Journalism Tracker, accused me of being wrong on the facts and several commenters defended Mayberg's research in using brain surgery for the treatment of unremitting depression.

Before I get to the gist of Raeburn's accusations, let me just point out that this isn't the first time that Dr. Mayberg, a neurologist at Emory University School of Medicine, has been less than forthcoming about her conflicts of interest. Mayberg was one of the authors on a 2006 paper that touted the effectiveness of a technique known as vagus nerve stimulation (VNS) in patients with treatment-resistant depression. Eight of the authors, including Mayberg, failed to disclose they had consulting ties with Cyberonics, the maker of the device that delivers electrical pulses to the vagus nerve in the neck. (The ninth author was an actual employee of Cyberonics). Because of this egregious failure to disclose, the lead author of the study, Dr. Charles Nemeroff, then chair of psychiatry at Emory, was forced to step down as editor in chief of the journal Neuropsychopharmacology, which published the VNS paper; read about the controversy here. Indeed, Nemeroff, who brought Mayberg to Emory, was forced to step down as chair at Emory last year after a Senate investigation found that he repeatedly failed to disclose to university and NIH officials the millions of dollars he was receiving from drug companies whose products he was touting in research papers and on the lecture circuit; read more about this here.

Mayberg also did not disclose the fact that she was a consultant for Advanced Neuromodulation Systems, a company that holds the patent on her surgical technique for deep brain stimulation, when she co-authored another 2006 article with Nemeroff that reviewed possible brain mechanisms for post traumatic stress disorder and concluded that Paxil might be an effective treatment for PTSD. The study, published in the Journal of Psychiatric Research, was funded by GlaxoSmithKline, the maker of Paxil. While Mayberg wrote about the possible involvement of Brodmann's area 25 in the brain in causing symptoms of PTSD, she did not disclose that she holds a patent for deep brain stimulation of that particular section of the brain or that she was a consultant for the company that is doing clinical trials on her surgical technique.

In my blog last week, I had reported that in her keynote at the Science Writers conference, Mayberg did not disclose that she is still a consultant for ANS, which also goes by the name of St. Jude Medical Inc. She did mention that she had a patent on the technique (which involves implanting electrodes in Area 25) and she referred on one slide to being a consultant for St. Jude Medical. Now, St. Jude Medical is a nonprofit hospital in California and so I (and others in the audience) assumed she was consulting for a nonprofit, not the for-profit company that is doing clinical trials on her patented technique. According to Raeburn who got in touch with Mayberg after I posted my blog, she said that "a review of her slides show that both ANS and St. Jude were disclosed." Now, maybe the good doctor does have a slide with ANS on it, but she did not put it up on the screen Nov. 7 and she did not mention it in her talk.

In my original blog, I also said that her "talk was heavy on anecdotal examples but skimpy on any real evidence of efficacy." She did say she was writing up a paper about her latest results but didn’t disclose much in the way of specifics. After I posted my blog, a reader sent me a summary of Mayberg's most recently published work on deep brain stimulation in UptoDate, a subscription only newsletter. Here it is:
“A case series of 20 patients with major depression unresponsive to more than 4 antidepressants and ECT (17 of the 20 patients) who underwent DBS with subcallosal electrode placement found response and remission rates to be 60 and 35 percent respectively at six months [49].”

A remission rate of 35 percent on 20 patients doesn’t seem that encouraging to me. More to the point, why didn’t Dr. Mayberg share this data with all of us science writers on Nov. 7?

Wednesday, November 10, 2010

Keynote scientist at ScienceWriters conference dances around the truth

Dr. Helen Mayberg, a neurologist at Emory University, had top billing at the annual Science Writers conference in New Haven Sunday to talk about her work in using deep brain stimulation to treat depression. Nearly 500 writers, editors, public information officers and students listened as she spoke of inserting electrodes into the frontal lobes of chronically depressed patients for whom other treatments (like drugs and ECT) have failed. She spoke with wonder of being able to help "patient after patient" awake from the fog of depression and how for some patients, the difference was like "night and day."

As it turns out, Dr. Mayberg left out a few salient details. To begin with, she never mentioned how many depressed patients have actually benefited from this risky surgical technique. She did say that in the initial feasibility study she and colleagues did in 2002 while she was at the University of Toronto, electrodes were surgically implanted in six patients and four out of six "got better and stayed better." She also alluded to a slightly larger study of 20 patients she conducted at Emory in which "patients are achieving remission." But she did not how many patients are actually in remission and for what length of time, or whether the results are statistically significant, only that "we are now writing up the paper for submission." Her talk was heavy on anecdotal examples but skimpy on any real evidence of efficacy.

Of equal concern, Mayberg did not fully disclose the extent of her conflicts of interest. At the beginning of her talk, she mentioned that she held a patent for the technique and that it was now in clinical trials. She also said she was a consultant for St. Jude Medical. Now, St. Jude Medical Center is the name of a well-regarded nonprofit hospital in California and the clear implication (to many of us in the audience) was that she was consulting for a nonprofit hospital. In fact, Mayberg is a consultant for Advanced Neuromodulation Systems, which also goes by the name of St. Jude Medical Inc., a for-profit multinational company that manufactures medical devices and has annual revenues of $4.6 billion.

This is the company that holds the patent for Mayberg's surgical technique and has begun clinical trials to test it. And it has a less than stellar reputation. Last year, the FDA hit St. Jude Medical, otherwise known as ANS, with a stern warning letter alleging that the company had failed to correct known design defects in spinal cord stimulation devices it sells to treat chronic pain. The FDA letter said the manufacture and installation of these devices are not in conformity with good manufacturing practice requirements and called the company to task for failing to respond to previous warnings from FDA inspectors about the devices' defects.

Now maybe St. Jude has cleaned up its act, although as of this afternoon a phone call to its corporate headquarters in St. Paul, Minnesota had not been returned. But if I were a chronically depressed patient being recruited for the company's ongoing clinical trials, I might think twice about participating. And if I had been one of the organizers for the 2010 Science Writers conference, I might have thought twice about inviting Mayberg to speak in the first place.