Holly Kelly Ennis
Bayer Hires Controversial Physician For Essure Clinical Trials
Bayer, the manufacturer of the highly controversial sterilization device Essure, is again coming under scrutiny due to problems arising from its post-market clinical trials regarding the safety of Essure. Following the September 24, 2015 FDA public safety hearing on Essure, the FDA mandated Bayer to undertake another clinical trial to study the risks and benefits in women undergoing either Hysteroscopic Sterilization (Essure) or Laparoscopic Tubal Sterilization. The study is designed to assess the outcomes of 2800 women (1400 undergoing each procedure) who suffer side effects including; pelvic and/or lower abdominal pain, abnormal bleeding, surgical intervention necessary and allergic, hypersensitivity and/or autoimmune responses. After much delay, the actual start date of the clinical trials was May 3, 2017 with a completion date of May 29, 2023.
This clinical trial is controversial for several reasons. As of October 19, 2017 only 136 women have been enrolled, but it is unclear which arm of the clinical trial, the enrollments have occurred. Additionally, Bayer claims it has until May 29, 2020 to complete its enrollment process, leaving only three years to study the results of the women implanted at that time. This is woefully inadequate given the fact that many side effects from the Essure device become apparent after three years. However, even more disturbing is the selection of biased clinical trial practitioners to be involved in the study.
Several clinical trial sites have recently been released and have
been posted on the ClinicalTrials.gov website. The most disturbing selection is
the Office of Dr. Cindy Basinski. Dr. Basinski
is a long time provider of Essure who has received over $70,000 in compensation
from Bayer. Most disturbing is the fact that in 2015, Dr. Basinski received a
violation notice from the FDA regarding improper conduct in a prior clinical
trial. The FDA investigator noted that
Dr. Basinski failed to timely report serious adverse adverse events involving
clinical trial participants. Dr.
Basinski was also noted to have added pertinent medical information to several
patient’s records, months after the
patient screening occurred and was cited for this conduct as well. Such
irresponsible and biased conduct should ban her from participation in the
upcoming clinical trials. Dr. Basinski’s partner, Dr. Rupal Juran is also
biased in favor of Bayer as she spoke in favor of Essure at the September 24,
2015 FDA public hearing. Finally, another
Essure physician who has been heavily compensated by Bayer, Dr. Amy Brenner is
also on the recently released list of clinical trial physicians. It is not surprising Bayer and the FDA would
allow such blatant bias to exist in these clinical trials.
In fact, the FDA was recently questioned by three U.S. Congresswomen, Rosa DeLauro, Louise Slaughter and Jan Schakowsky regarding Essure and the upcoming clinical trials. They are deeply concerned that the FDA has allowed Essure to remain on the market even while the post-market safety trials are taking place. The Congresswomen requested a meeting with the FDA officials within a month to address their concerns regarding Essure and the problems with post-market surveillance. Hopefully, the latest revelation concerning the blatant conflicts of interests in clinical trial physicians will also be discussed.
For more information regarding Essure, contact Holly Ennis at Ennis & Ennis, P.A. at Holly@Ennislaw.com or visit us online at www.Ennislaw.com.