An astonishing article appeared in the March 2, 2016 edition of The New York Times. In what they called a “startling accusation,” lawyers in litigation against drug manufacturers Johnson & Johnson and Bayer concerning the prescription anti-clotting drug Xarelto, claim that important data was omitted by researchers from Duke University in a letter to the editor published in the prestigious New England Journal of Medicine.
Xarelto, which had sales of close to two billion dollars in the United States alone last year, is a blockbuster drug in the area of blood thinners. It is marketed in the United States by Johnson & Johnson and overseas by Bayer. The two pharmaceutical manufacturers hired the Duke Clinical Research Institute to conduct a three-year clinical trial involving 14,000 patients in order to get Xarelto approved for sale by the regulatory agencies.
In the fall of 2015, subsequent to approval of the drug, the companies notified the regulators that a blood-testing device used in the study had malfunctioned. Last month however, the researchers from Duke published their own analysis in The New England Journal of Medicine stating that the problems associated with the blood-testing device did not affect the results of the clinical trial. Other medical researchers have criticized these analyses. They believe comparing testing data from a central laboratory could evaluate whether or not the device malfunction affected the results of the study. In fact, that central laboratory testing had been done at two points during the course of the clinical trial, but this existing laboratory data was not referred to by the researchers in their letter to the editor.
Note that Duke and Johnson & Johnson have contended that they worked independently of one another and that Bayer declined to comment concerning this recent allegation. Also, this is indeed an allegation made by plaintiffs’ lawyers in a court pleading and is not conclusive at this point. The pharmaceutical manufacturers will still have the opportunity to respond in court to this new allegation.
The concealment of research data is not a new phenomenon or issue. Several years ago in litigation against Merck concerning the pain killer Vioxx, an allegation was made in the course of the litigation that the manufacturer had concealed or altered data in articles which had been published in medical journals concerning the safety and efficacy of that drug. In response to those allegations, The New England Journal of Medicine published what was a very rare “Expression of Concern” after it learned that researchers had failed to include three heart attacks in a published study. As a result of that episode, authors in major medical journals are now required to disclose any outside financial interest as well as any role that drug manufacturers played in the articles’ publication.
While this recent allegation against Johnson & Johnson & Bayer still remains to be played out in court, perhaps the best statement on the matter is by Dr. Lisa Schwartz, a Professor of Medicine at Dartmouth who stated, “It just feels like it’s a real ethical breach. If you know the direct answer to this question, then how can you not provide it to be able to be of insight?”