Something similar seems to be happening in the Accutane litigation. There’s a new opinion, Palazzolo v. Hoffman-La Roche Inc., No. A-3789-07T3, slip op. (N.J. Super. App. Div. Feb. 3, 2010), in which another plaintiff’s expert has gotten called out for essentially the same thing – publishing an article in a medical journal that failed to accurately describe what was actually done.
Be ready to hold your nose, here's what went down, and it ain't pretty:
In Palazzolo the plaintiff’s expert, James Bremner, was hired to offer an opinion that Accutane caused depression and suicide. The sticky situation began when, in the words of the Court, “Plaintiffs paid Bremner to undertake a further study. There is no dispute that the study was commissioned specifically for use in this litigation.” Slip op. at 3. That study – bought and paid for by plaintiffs’ counsel – was nevertheless published at J. Douglas Bremner, M.D., et. al., “Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin,” 162 Am. J. Psychiatry 983 (May 2005). Slip op. at 4. You can read the whole thing on line here.
- “Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article.” Slip op. at 10.
- “[C]ontrary to representations made in the article, he did not get before-and-after. . .questionnaires from many of the subjects.” Id. at 10-11.
- "Bremner also could not document much of the data on which his published results were based." Id. at 11.
- “[H]e admitted that some of the statistical analysis was inaccurate. For example. . .Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.” Id.
- “[H]e testified. . .that the ‘absolute metabolic rates’ for the two groups was significantly different, and contended that was the key finding of the PET study. However, Bremner. . .could not produce the source data for that analysis because [it] was on an optical computer drive that could not be opened.” Id.
- “[H]e admitted that some of the [data] he used in his calculations were inaccurate, [but] could not check the accuracy of the remaining numbers because the original data could not be retrieved.” Id. at 12.
Thus, even after holding that Dr. Bremner's main basis for his testimony was an "article [that] does not accurately represent either the underlying data or what the author did," the court was nevertheless willing to allow him to offer an opinion in the same matter. Amazing.
On a more general level, we are, frankly, sick and tired of hearing the academic types and the popular press moan and wring their hands about the fact that our clients fund a lot of published studies in the medical literature. If they didn’t, there wouldn’t be very much literature, and the journals would have to print more junk science along the lines of the Lancet and the American Journal of Psychiatry articles.
And mere disclosure's not enough. The ordinary peer review process doesn't seem to be robust enough to ferret out litigation-driven academic fraud. So we think that if the answer to the disclosure question is “yes,” more needs to be done. If there’s a litigation expert seeking to publish about anything litigation related, we think academic journals – to safeguard their own integrity – should include at least one opposing-side litigation expert in the peer review process.