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.
Health & Medicine
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.
XenoPort is developing a new psoriasis drug but has hit some snags. During patient trials, one-third of the study participants dropped out due to severe gastrointestinal side effects involving diarrhea.
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.
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.
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.
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.
The bill also comes as residents will likely vote on legalizing marijuana for recreational use next year. As the current medical marijuana industry is regulated through a patchwork of city and local ordinances, Brown and other legislators have been trying to mitigate the concerns of industry lobbyists, law enforcement, local administrators, and opposition lawmakers in advance of the likely 2016 ballot measure.
As more cancer diagnoses related to 9/11 are discovered, the costs for the health program, as well as the over 6,500 people enrolled in the victim fund, will likely increase. This means Congress will either have to allow for the funding increase, or services may get cut dramatically. The decision could have life or death consequences for some like 52 year-old retired NYPD detective Barbara Burnette, who has a debilitating lung condition. Doctors have told Burnette that she will eventually require a double lung transplant. Burnette notes the potential lack of funding, saying “Without this program, people are gonna die, and I’m going to be one of them.”
NAS began the study in 2010, and completed the first phase in 2012. The next phase had been underway for about three years when it was halted. The study was to have been an update to a 1990 review conducted by the National Cancer Institute, which analyzed cancer death rates in areas near 52 nuclear plants. That study concluded that there was no increased risk of cancer for people living close to the nuclear facilities.