29 July 2018

Bayer Reportedly Paid Physicians to Push Essure onto Patients

On July 27, a CNN exclusive report revealed that Bayer had paid physicians millions of dollars to endorse Essure, a high-risk permanent birth control implant. Christina Potts, one of the patients interviewed by CNN, described her doctor as being a cheerleader for the Essure device and nothing else. After receiving the implant, Potts was left feeling extremely fatigued and in terrible pain.

She felt so bad that she opted for a hysterectomy and had her uterus and fallopian tubes removed in order to rid herself of the Essure implant. Earlier in July, the FDA expressed more concerns over Essure and shortly thereafter, Bayer announced that the birth control implant would be pulled from US markets by the end of 2018.

Bayer Paid Doctors to Endorse Essure Implant

Patients like Potts are left wondering if gynecologists recommended Essure because it was the best option or because they were being paid thousands by Bayer. After analyzing federal data, CNN determined that Bayer paid 11,850 physicians $2.5 million in consulting fees and similar services associated with Essure between August 2013 and December 2017. CNN notes that while the payments are all legal, they are still highly controversial.

CNN may have chosen to interview Potts specifically because as they note, her physician, in particular, was one of the highest paid by Bayer. Between August 2013 and December 2017, her doctor received over $168,000 in consulting fees and similar services related to Essure. Over 80 percent of the funds paid to Indiana physicians by Bayer were allocated to this one particular physician.

Physicians Paid Thousands to be Essure Advocates

The Indiana gynecologist, Cindy Basinksi, is only one of three physicians receiving over $100,000 from Bayer in the US. She is the second-highest paid and told CNN that she had also been receiving payments from Bayer for five years further back than the database shows. Earlier on, she said she received close to $5,000 to $7,000 per month from the manufacturer. She remains committed to Essure’s safety and will continue implanting the device until it’s pulled from the market.

Basinksi says she did a lot of work for Bayer’s money, including educating other physicians. According to researchers at top-tier universities like Yale University, Harvard Medical School, and UNC, physicians are more likely to prescribe the drugs from the pharmaceutical companies that are paying them. The pay involved in these types of studies is much more modest than the disbursements Basinksi was receiving from Bayer.

Basinksi maintains that her clinical judgment was not influenced by the money from Bayer. She claims she would’ve made the same amount if she was working during the hours she was paid to educate doctors about the Essure device and how to implant it in patients. Basinksi says she believes a professional relationship can exist between physicians and the companies, and claims she has turned down money before for products she didn’t believe in.

Mounting Pressure over the High-Risk Medical Implant

The same day Bayer announced it would pull Essure over declining sales, the FDA released a statement highlighting the safety risks associated with the device, including migration of the coils into the abdomen or pelvis, perforation of fallopian tubes and uterus, and persistent pain. Days later, Netflix released “The Bleeding Edge”, a documentary covering the dangers associated with Essure and different medical devices.

The documentary focuses women who banded together and lobbied for years to have Congress ban Essure from US markets. Essure Problems is a private Facebook group that amassed 37,000 members, with at least 12,000 who have undergone a hysterectomy or other procedure to have the permanent birth control implant removed. For many women, permanent birth control can be the right choice at the right time, but there are different options to consider.

The Doctor-Patient Relationship and Essure

Potts recalls feeling like Basinksi was very pushy in preference for Essure over having the fallopian tubes tied. Basinksi told Potts that Essure was easier and didn’t involve the recovery time that the surgical procedure would. According to CNN, Potts was not the only patient they interviewed who’d describe Basinksi as a cheerleader for the Essure implant. A year after the implant, Potts said she had begun suffering from extreme fatigue, abdominal cramping, joint pain, and headaches.

Potts said she didn’t call Basinksi about how she was feeling and was forced to rely on her oldest child to help with the three younger ones. Since having the hysterectomy, Potts says that the symptoms she was struggling with are almost gone completely. Potts still feel violated and angry over Basinksi dismissing her preference to get her tubes tied and recommending the high-risk implant instead.

Potts claims she felt it was really Basinksi’s decision because she knew best and no other option was really offered. Basinksi doesn’t recall their interaction specifically but claims the patient must be misremembering because she routinely offers different choices for sterilization procedures. She cited her notes, claiming that she did discuss alternatives, benefits, and risks with the patient. However, another patient also claims that Basinksi dismissed tube litigation in favor of Essure on another occasion.

Doctor Marketing and Recommending Essure

This other patient, who was interviewed by CNN anonymously, chose to contact a different physician to have the Essure implant removed. According to Basinksi, she may have seemed over-enthusiastic or stressing the Ensure simply because it was a new device. She says that because the device was just approved by the FDA for the first time in 2002, sometimes it takes more explanation than the traditional methods.

Basinksi says she’s obligated to discuss the risks and benefits for all the available options, and then provide her professional recommendation. Patients interviewed by CNN claim her marketing for Essure calls that statement into question. Basinksi can be found marketing Essure pretty actively, including a history of having a highway billboard, a website, and videos on YouTube. During 2009, she appeared on the “Balance Act” show alongside a Bachelorette contestant with an Essure implant promoting the device.

CNN interviewed two patients of Basinksi’s who were satisfied with the device and her conduct relating to any information or recommendations she provided. According to Bayer, doctors are compensated for the services and expertise provided to the pharmaceutical industry, claiming that it’s both ethical and appropriate to compensate physicians for the time spent on these activities. It may be ethical to compensate physicians for genuine research, but many doubt that the 11,850 physicians were involved to that degree.

The Torrid History of the Essure Implant

According to the FDA, over 750,000 people worldwide have used Essure since it was made available in November 2002. Between 2002 and 2017, over 21,000 patient reports involved abdominal pain, over 9,800 involved in menstrual irregularities, over 7,300 were related to headaches and nearly 5,000 involved weight fluctuations. An industry expert is quoted saying the Essure story looks like a bribe, that they are gaming the system and potentially paying off doctors.

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