Health & Medicine Archives - Page 363 of 373

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

Staff - September 28, 2015

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

Staff - September 26, 2015

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.

FDA Panel to Review Essure Risks

Staff - September 23, 2015

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

Staff - September 21, 2015

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.

Will Industry Ties Hamper Nominee for FDA Commissioner?

Staff - September 20, 2015

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

Staff - September 17, 2015

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.

FDA Pulls Four R.J. Reynolds Cigarette Brands from Market

Staff - September 16, 2015

The FDA cited various reasons for the violations in its press release. As an example, the agency cited that the filter on the Camel Crush Bold cigarettes contain a capsule that when crushed, releases additional menthol flavoring. The agency found that the feature creates a significant difference from products that existed prior to the law. The Campaign for Tobacco-Free Kids president Matthew Myers praised the decision, believing that the Camel Crush cigarettes “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.” According to Myers, Camel is the most popular cigarette brand among young smokers.

Is Salmonella Winning?

Staff - September 15, 2015

The problems are not confined to just California or Texas by any means. The Minnesota Department of Public Health said in a September 10th news release that 45 cases of salmonella have been reported likely involving at least 17 different Chipotle restaurants throughout the state since September 2nd. Halfway across the country in the nation’s capital, up to 70 cases of salmonella-related illnesses have been traced to the upscale chain restaurant Fig & Olive’s Washington D.C. location. Among the cases, six have been confirmed to contain a salmonella infection. These cases follow the September 2nd press release by the Food and Drug Administration (FDA) that New York specialty online retailer Sincerely Nuts is recalling several macadamia nut products due to traces of salmonella found during routine lab testing.

FDA Panel Unanimously Recommends Approval for Abuse-Deterrent Painkiller Xtampza

Staff - September 14, 2015

Despite the dosing warning issued by the Food and Drug Administration (FDA) earlier last week amid concerns about the product’s labeling, an independent panel commissioned by the agency recommended approval for a experimental oral painkiller. The panel’s 23-0 vote is a major win for Massachusetts-based Collegium Pharmaceuticals, and its potential breakthrough drug marketed as Xtampza.

DuPont Faces First Trial Involving West Virginia Chemical Leak

Staff - September 14, 2015

Bartlett, a 59 year-old resident of Guysville in Athens County, Ohio was diagnosed with kidney cancer in 1997. Among other charges, Bartlett accuses DuPont management of negligence for allowing the leak, fraud and concealment for failing to inform the public of the dangers, and trespass and battery for letting the pollutants enter her bloodstream. DuPont attorneys blame Barlett’s kidney cancer on other factors instead, including obesity.

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