Taxotere, the synthetic version Taxol, is a drug used for the treatment of many types of cancer, including lung, breast, prostrate, stomach, and head/neck. It is manufactured by Sanofi-Aventis, a global pharmaceutical company that has a United States based headquarters in New Jersey. The drug was approved for use in the treatment of breast cancer
In June, 2016, the Inspector General, Daniel R. Levinson, notified Robert M. Califf, M.D., Commissioner of Food and Drugs, Food and Drug Administration, FDA, that, as a result of an ongoing audit his office was conducting, it was found that the method that the FDA used to initiate a food recall was inefficient and ineffective.
This equivocates to roughly one out of 49-50 women needing surgery to repair or remove the device. Dr. Sedrakyan also added that the “surgery is likely to be much more complicated than the laproscopic approach that they should be considering. For its part, the FDA has acknowledged the study, releasing a statement saying “This is a high priority issue for the agency. The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device and input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate.” The FDA has not indicated, however, that it is planning on pulling the device from the market.
Congressman Fitzpatrick’s law simply reads: “Not later than 60 days after the date of enactment 8 of this Act, the Commissioner of Food and Drugs shall issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure System.” Essure Problems is also asking others who have experienced complications from the device to also send their Representatives this letter (which is provided in Word Doc. Format at the bottom of the page).
We have the answers for you panel members, we have the answers for you FDA, all you have to do is ask us and we will show you. I am not a doctor, I am a metal smith. But that does not make my knowledge of Essure less real, it doesn’t make our knowledge or our information untrue. We can present to you allergy reports, operative notes, toxicology reports, blood work, x-rays, CT scans, MRIs, radiology reports, we have the medical information right in our hands.
After the intense discussion and testimony, the FDA panel recommended that more data be collected regarding skin allergies and other symptoms, as well as demanding that doctors need to be trained more thoroughly on how to implant and remove the device, although stopping short of demanding that Bayer recall the product.
Although no formal decisions will be made at Thursday’s meeting, the experts will consider whether or not to require a warning label on the product and if more clinical studies are needed to ensure the safety of the device.
In total, the researchers from the nation’s largest brain bank examined 165 brains of people who played football professionally, semi-professionally, or in college or high school while living. The brain bank is run as a joint venture between the VA and the university. They found 131 of the brains showed some evidence of CTE, including the 87 NFL pros.
Dr. Califf, a cardiologist, has been serving as the FDA’s deputy commissioner for medical products and tobacco since he joined the agency in February, divesting interest in his pre-FDA activity. Although he has donated his proceeds from private industry to nonprofit groups since the mid-2000s, Dr. Califf has taken some form of financial support from over 20 companies according to a disclaimer added to the end of a European Heart Journal article he penned last year. His financial disclosure form for 2014 alone lists consulting fees provided to him from seven companies, and his salary at Duke was funded in part by drugmakers Merck, Novartis and Eli Lilly.
Opdivo was first approved in Japan in July 2014 for the treatment of melanoma and nivolumab was approved by the European Commission this past July for the treatment of lung cancer. The FDA also approved Opdivo for the treatment of melanoma in December and lung cancer in March. In addition to being granted breakthrough designation prior to its two FDA approvals, it has also been given the status for the treatment of Hodgkin lymphoma.