Mesh News Desk, March 14, 2014 ~ Some of the names in this story may sound familiar, primary among them Dr. Vincente Lucente. He was one of the doctors mentioned during the Linda Gross transvaginal mesh trial naming manufacturer Ethicon (Johnson & Johnson).
Lucente was one of the young doctors brought under the wing of Ethicon to be a preceptor, or trainer of other doctors on the new transvaginal mesh procedures involving mesh “kits.” In doing so, he trained many doctors that this could be an exciting new source of revenue for a practice for a “minimally-invasive” procedure that can be performed in about 20 minutes.
Lucente’s name is central to this Wall Street Journal (WSJ) article from March 13th and his influence reportedly extended beyond training and bringing new doctors into the Ethicon fold.
For his efforts he received a reported $800,000 over 10 years. There are no restrictions on company compensation to consultants, though the Physician Payment Sunshine Act of 2010 is supposed to make that transparent.
“Emails and other documents related to the Ethicon suits, provided by the company during the discovery process, suggest that a physician paid by J&J as a consultant sought to influence the language in treatment guidelines for prolapse put forth by a medical society in 2007. The company also sought to change the language of a high-profile research paper on the mesh procedure published in the New England Journal of Medicine in 2011, the documents show.
The editors of the New England Journal of Medicine are reportedly fighting a subpoena to testify, according to the article.
Back in 2007, the American College of Obstetricians and Gynecologists (ACOG) was prepared to publish a practice guideline for doctors on mesh kits (Prolift for example).
It called them “experimental.” Lucente, a doctor from Allentown, PA told J&J that word had to go, according to emails gathered in preparation for Ethicon lawsuits filed by attorney Adam Slater in New Jersey state court.
Using the word “experimental” would scare off patients and besides, the kits had cleared the FDA.
[Sidebar here- remember Ethicon put Prolift on the market with no notification. It was only noted by the FDA when Ethicon wanted to clear the Prolift +M and put Prolift as a predicate. The FDA noticed the oversight and went ahead and cleared Prolift in 2008 with no sanctions against J&J.]
Yes the word “experimental” in an ACOG bulletin would be a problem agreed David Robinson, the medical director for Ethicon in 2007. But Ethicon had to be careful not to be seen as too involved in lobbying ACOG to change the wording of any bulletin.
An email from Robinson says “Our work remains in the background.”
“ACOG’s initial bulletin was published in February 2007 and stated: “Given the limited data and frequent changes in the marketed products…the procedures should be considered experimental and patients should consent to surgery with that understanding.”
ACOG soon began receiving emails and phone calls from its members who did not like the word “experimental” either.
“In late August, Dr. Lucente alerted Price St. Hilaire, Ethicon’s U.S. group marketing director, that ACOG was changing its practice bulletin, according to emails. “Note, no further use of the word experimental!” wrote Dr. Lucente. “Well, this is one I’m taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin.”
Seven months after the first bulletin, the word “experimental” was removed. According to Dr. L. Lewis Wall, a urogynecologist from Washington University, the speed of the change was unprecedented.
Meanwhile consultant dollars went to Dr. Daniel Altman who authored a favorable article on Ethicon for the New England Journal of Medicine. That story was published by Mesh Medical Device News Desk on the Linda Gross trial, February 9, 2013 here.
Wall Street Journal March 13, 2014, Doctors, Device Makers Close Ties here