Behind The Red Tape – By Angie Firmalino, Founder of Essure Problems

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.


Bayer, Essure Take Beating at FDA Risk Panel

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.


We Should Thank Martin Shkreli

We should thank Martin Shkreli, the man who bought the only drug to treat toxoplasmosis and promptly raised the price through the roof. Why should we thank him? Due to his outrageous, cavalier attitude toward the issue and his failure to hire a PR firm to do the talking, he put Big Pharma and its ridiculous pricing policies under a huge spotlight.


FDA Panel to Review Essure Risks

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.


Study Finds Nearly 96 percent of Deceased NFL Players had CTE

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.


UK Man Learned Viagra Lesson the Hard Way

A UK man got a big surprise when his joke backfired and he ended up in hospital. Daniel Medforth though it would be funny to take 35 Viagra pills at the same time. Boy, was he ever wrong. He got quite sick and ended up hospitalized for five days. All the while, “Little Daniel” had the worst case of penis insomnia on record, being “up” for the whole time. That’s right, Medforth had to contend with a never-ending supply of erections.



Class I Recall SynCardia Systems Freedom Driver

The FDA issued its most serious level of recall, a Class I, on SynCardia Systems Total Artificial Heart Freedom Driver due to a potentially deadly defect.Part of the driver may fail, causing the artificial heart to stop pumping blood. This can result in serious injuries, up to and including death, if the patient is not immediately connected to a new driver.


Will Industry Ties Hamper Nominee for FDA Commissioner?

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.


FDA Grants Bristol-Myer’s Kidney Cancer Drug ‘Breakthrough’ Status

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.