The U.S. Food and Drug Administration (FDA) opened an investigation of Bayer pharmaceuticals in response to a citizen’s petition filed March 26th on behalf of over 2100 women regarding the Essure permanent birth control device. Bayer, who acquired the product’s maker, Conceptus in 2013, is being accused of hiding falsified medical records and reports of adverse events by Coneptus prior to being granted FDA approval. The women claim that the device, which is inserted into the fallopian tube, has caused bowel perforations, splintering, and other malfunctions that have caused intense pain and several cases of unintended pregnancy. Bayer has aggressively denied these claims and insists the product is safe, hinting even at frivolousness and overzealous litigation by the firm filing the petition. The FDA, however, may choose to ban the device depending on the results of the investigation.
Some of the more alarming allegations in the petition include Conceptus:
– Only reporting 22 of the 168 adverse events, including splintered coils and bowel perforations, to the FDA
– Changing the birth date of a patient by 20 years, and
– Claiming that only 4 pregnancies occurred between 1997 and 2005 when evidence shows the actual number to be 64.
The FDA granted conditional “pre-market approval” (PMA) for Essure in 2002, which protected Conceptus from lawsuits based on adhering to a strict research protocol that was thought to be too rigorous to produce any kind of legal liability. The petitioners claimed, however, that this process was rushed and sloppy on this occasion. Citing this, as well as the falsification to be in violation of the PMA conditions, the first lawsuit regarding these claims was filed in July, 2014 and several firms are currently recruiting plaintiffs for class-action procedures. Adding to the investigation and pending lawsuits, noted consumer advocate, Erin Brockovich, launched a PR campaign against Bayer, and product sponsor and former Olympic skier, Picabo Street, was dropped after becoming pregnant while having the device implanted.
If true, the allegations could not only be a looming death sentence for Essure, but it puts the credibility of Bayer’s research protocol in major jeopardy. The company has aggressively defended the product, and as Dr. Adam Levy concurs, “I can say that if properly done, this is a remarkable method that is safe and effective. The materials are not toxic, and perforation while a possibility, is both rare and easy to detect.” Even if these events are rare however, even statistically rare; reports of cheating clinical research severely undermine the process itself. Foremost, since Bayer bought the company that is actually accused of giving falsified information, how much knowledge did they have of it beforehand? The petitioners claim that Bayer had knowledge of over 16 thousand trial cases that were not reported to the FDA during the clinical process found in an Excel file.
If this is confirmed by the investigation, one has to wonder if Bayer has misled the agency about any other products. In an industry where statistical accuracy is so paramount and the real-world consequences so severe, is falsification not the cardinal sin? Moreover, is the PMA process a license to cheat or slack? Perhaps, if anything, this investigation will lead to reconsideration about how much provisional trust the FDA can give to pharmaceutical companies during the R&D process.
Medscape – Troy Brown
Newser – Matt Cantor
LifeSite News – Kirsten Anderson