Essure Depicts Classic Examples of FDA Conflicts and Corruption

04/06/2016 - The Food and Drug Administration has a sordid history of scandals involving conflicts of interests, cover-ups, corruption and congressional investigations. A recent investigation into the approval and continued protection for the controversial sterilization device Essure, depicts classic examples of controversial conduct by the FDA, sanctioned at the highest levels. Although the FDA is entrusted to protect the public’s health, more often its interests align with lining the pockets of the pharmaceutical and medical device industries, where many FDA employees ultimately seek their golden parachutes. Such conduct begs the question why Essure’s PMA has not been revoked nor the product recalled, despite a plethora of evidence of significant injuries caused by the device.

Regarding conflicts of interests pertaining to the Essure device, the FDA allowed Cindy Domecus to serve both as Senior Vice-President of Clinical Research and Regulatory Affairs at Essure’s manufacturer, Conceptus, while also serving on the FDA’s Obstetrics and Gynecology Device Panel from 1995-2001. Much of Essure’s development and clinical studies were undertaken while Ms. Domecus served both Conceptus and the FDA. Not surprisingly, Essure received a “fast track approval” from the FDA and was granted, “expedited review status.” “We have been very appreciative of the Agency’s input throughout the course of the Essure product development and of their willingness to consider the least burdensome and most expeditious route to PMA filing,” said Ms. Domecus. Clearly having your Vice President of Clinical Research serve on the FDA Advisory Panel reviewing your device makes the process more “expeditious” and “less burdensome.”

Also of interest is that Ms. Domecus served on the FDA panel and approved the ablation device, ThermaChoice, manufactured by Gynecare/Ethicon. Susan Aloyan submitted the PMA for ThermaChoice on behalf of Ethicon. Ms. Aloyan was later hired by Conceptus in 2001 and reported directly to Cindy Domecus. Not long thereafter, on October 30, 2003, Conceptus and Gynecare/Ethicon entered into a Joint Marketing or Co-Promotion Agreement wherein Essure and the ThermaChoice ablation procedure would be heavily marketed and encouraged for use together by sales representatives from both companies. This joint venture was entered into before the parties had obtained FDA approval to utilize the ablation and Essure procedures together. This joint venture ended when it was later determined that Essure and ablation procedures were not suited to be performed together.

The FDA also has a long history of keeping information from the public, particularly regarding clinical trials and studies. A study performed by NYU professor, Charles Seife, showed that, “ When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of the experiment are not to be trusted. On the contrary, for more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses, The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.” Perhaps this is why the allegations of Essure clinical trial misconduct has been completely marginalized and ignored by the FDA.

Selfie sums up his view of the FDA, which is justifiably held by many that, “The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but also by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured and drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.”

The FDA is complicit in actions by the medical device industry it knows to be unethical. Take for example the nickel allergy warning on the Essure device. The product initially had a warning regarding potential allergic reactions to nickel. However, when it became inconvenient to have such a warning, Conceptus applied for and the FDA agreed to have this warning simply removed from the product labeling. The FDA was just as complicit in this egregious conduct as was Conceptus, which based its action on greed in order to gain an edge over its only competitor at the time. "This FDA label decision will further strengthen our competitive advantage and leadership in the permanent birth control market, and we are pleased that we were able to secure it," said Mark Sieczkarek, president and chief executive officer of Conceptus. "The upgraded label change significantly diminishes the biggest competitive selling point of our competitor's hysteroscopic sterilization product against Essure, which was the nickel hypersensitivity contraindication. We will be aggressively marketing this IFU change to the OB/GYN community, and especially to those physician accounts that are trialing the competitor's product primarily because of potential nickel allergy in patients," said Mr. Sieczkarek.

Other questionable FDA conduct potentially protecting Essure has occurred at the highest levels. In March 2009, Senator Charles Grassley publicly admonished acting FDA Commissioner and former Chief Scientist, Frank Torti Sr., for an email sent to FDA employees, which was clearly intended to silence whistleblowers. The email came just after nine FDA scientists wrote a letter to President Obama requesting sweeping reform to clean up the “corrupt” FDA. After this letter was sent, the staffers said the FDA spied on their private emails, harassed them and in some cases fired the whistleblowers. Internally the group was known as the “FDA Nine”. Some of the highest-ranking officials were later sued in a lawsuit bought by the aggrieved employees, including Margaret Hamburg, Jeff Shuren and William Maisel.

Torti basically ordered FDA employees not to respond to requests for information under the Freedom of Information Act or even to Congressmen seeking information. What is particularly interesting is that Frank Torti’s son, Frank Torti Jr., had recently joined the venture capitalist firm, New Enterprise Associates (NEA). NEA was a major contributor for the startup of Conceptus. It is imperative for venture capitalist to recoup their investments, particularly in medical devices. Accordingly, any problems with medical devices are often underreported as negative information can impact sales and the ultimate purchase of a medical device company. As such, it was imperative to the Torti family to keep any negative information concerning Essure and other devices under wraps for as long as possible to keep stock prices high.

Furthermore, after Frank Torti’s quick departure from the FDA, Margaret Hamburg was appointed as FDA Commissioner in May 2009. Margaret Hamburg is married to Peter Brown, CO-CEO of Renaissance Technologies. At times, Renaissance Technologies was one of the largest shareholders in, you guessed it, Conceptus. Margaret Hamburg and her husband, Peter Brown, were recently sued in US District Court for the District of Columbia. Hamburg and Brown were sued in their individually capacities, claiming that they had both substantially financially benefitted by Hamburg’s failure to order more adequate information to be put on the label of a controversial antibiotic, Levaquin, because of her husband’s stock interests in Renaissance Technologies. A similar argument can be made concerning the Essure device. Concerns regarding Essure have been virtually ignored until the FDA was finally forced to hold a public hearing on September 24, 2015 after Hamburg stepped down as FDA Commissioner.

During Hamburg’s tenure, the FDA clearly knew or should have known of complaints regarding the device. Two separate facility inspections performed by FDA employees revealed thousands of unreported complaints to Conceptus regarding Essure. During an inspection ending on January 6 2011, FDA investigator, Timothy Grome, reviewed an excel spreadsheet containing 16,581 complaints received on Essure during a 24 month period from 1/1/2008 through 12/6/2010. Additionally, on a subsequent inspection ending on January 26, 2013, the FDA investigator also reviewed an excel spreadsheet depicting complaints received during the 24 month period from 1/1/2011 and there were 16,047 additional complaints. It is unfathomable that the FDA would simply ignore over 30,000 complaints regarding the Essure device. As such, it begs the question, was Hamburg ignoring such complaints, keeping stock prices high? Shortly after the second investigation ended on January 26, 2013, Bayer purchased Conceptus for an astounding $1.1 billion dollars in April 2013.

Examples of conflicts and questionable conduct by the FDA are many and varied. Suffice it to say, the FDA no longer serves to act in the best interest of the public, but has become a virtual puppet of the pharmaceutical and medical device industries. As such, Congress must intervene and pass such legislation such as the E-Free Act to force the FDA to do its job appropriately and to protect the public from harmful and defective medical devices. Congressman Fitzpatrick is continuing his efforts for the House and Senate to pass the E-Free Act and revoke the FDA approval of Essure. He is also introducing new legislation to eliminate the blanket civil liability protections that device manufacturers enjoy for non life-saving devices because individuals harmed deserve a voice in court.