The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson.
Amid the hundreds of thousands of pages of documents provided in the 17,000 cases filed in federal court and 5,000 in New Jersey alone, is a conflict of interest relationship that shines light on how things work when industry wants something. Take urogynecologist and surgeon Dr. Vincent Lucente. There is not a study the doctor has undertaken without industry support over his 20-year-plus year career. But when working as a consultant for Ethicon, Dr. Lucente effectively changed the language concerning the mesh placement procedure which was published by a professional medical group.
In early 2007, The American College of Obstetricians and Gynecologists (ACOG) was on the verge of publishing its guidelines for the use of mesh kits. The Prolift was the first kit sent to doctors precut with delivery tools called trocars, stainless steel medieval meat hooks that guide the plastic mesh into a women’s pelvis through the vagina. The problem was this new device and procedure was being dubbed “experimental” in the ACOG practice guidelines. That determination would not allow insurance to pay for the procedure and was a real stumbling block to a lucrative outreach and marketing.
J&J could not been seen lobbying, according to the medical director of Ethicon, David Robinson, according to emails contained in discovery. “Our work has to remain in the background’ said Robinson. Dr. Lucente came to the rescue of Ethicon.
He called ACOG to educate the group about his concerns after the bulletin was issued with the word “experimental.” Whatever he said worked. In seven months there was a turnaround in ACOG. By August 2007 the word was gone from the ACOG practice bulletin.
“Well this one I’m taking credit for,” said Dr. Lucente in emails. Over ten years Dr. Lucente was paid about $800,000 to educate other doctors on the TVM procedures. Since Dr. Lucente did not serve in a leadership role in ACOG, his financial disclosures were not required.
According to his expert report in the Donna Cisson v. C.R. Bard case he says he has since 2004 performed the TVM procedures on more than 2,000 patients. In his deposition he claims to “have helped to lead the refinement of surgical techniques to optimize effectiveness and safety” of the TVM procedure, he claims to be an early adaptor of “surgical innovations for treatment of POP and SUI.” He says he performed the first TVT procedure in the U.S. on October 4, 1998.
The conflict involving the New England Journal of Medicine concerns an article written by a Dr. Daniel Altman of Karolinska University in Sweden. The university received $750,000 from Johnson & Johnson to support his research, as long as the company owned the data. It also reserved the right to stop the story at any time. Dr. Altman reportedly refused to sign that agreement. He wanted to work independently from J&J so the contract was changed and he was given control over the trial, reports the WSJ. The study was done and ready for publication in the NEJM in 2010. A disclosure of conflicts is generally required by publishers and his claims there were no conflicts. However emails show there was substantial back and forth between Dr. Altman and Dr. Piet Hinoul, the Worldwide Medical Affairs Director for Ethicon Women’s Health and Urology unit. Dr. Altman was asked to remove information about the number of women who had pain during intercourse. The final paper omits sexual pain. It does include the percentage of women needing corrective surgery after a mesh implant. Ethicon denies it improperly influenced the study but last year the NEJM had to correct its disclosure and added that J&J reviewed the study and draft prior to publication. J&J denies it influenced the final paper.
Many doctors rely on professional journals such as the NEJM to determine their practice of medicine. The WSJ reports the editors of the NEJM have been subpoenaed to testify in the litigation and to bring documents. So far they have resisted.