A bipartisan group of U.S. senators and representatives has introduced legislation to reauthorize the James Zadroga 9/11 Health and Compensation Act, to continue programs providing medical treatment and compensation to 9/11 responders for another 25 years.
Senators Kirsten Gillibrand and Chuck Schumer and seven other senators introduced the legislation in the Senate. The House bill was introduced by Representatives Carolyn Maloney, Jerrold Nadler, Peter King, and 37 others. New York City’s mayor, Bill de Blasio, along with 9/11 first responders, community survivors, and union leaders joined the effort to reauthorize the programs, 9/11 Health Watch reports. Continue reading
A new study involving artificial sweeteners has found that the additives may be making Americans fatter.
The study revealed that artificial sweeteners may trigger “dramatic” blood sugar disturbances in people and mice. This appears to happen because of the way in which the sweetening additives alter the gut’s bacterial populations, or microbiota, according to the National Post. The microbiota are an intricate ecosystem of bacteria and microorganisms that live in the gut.
The study, conducted by scientists in Israel, was released Wednesday by the journal, Nature. The research calls for a reassessment of the use of artificial sweeteners, which are one of the most widely used food additives globally, wrote the National Post. Continue reading
An expert witness in the multidistrict litigation over Chantix (varenicline), a smoking cessation drug, has moved to unseal court records in advance of a Food and Drug Administration (FDA) meeting to consider whether the drug should carry a warning about suicide risk.
Dr. Joseph Glenmullen, an expert causation witness for the plaintiffs, and Thomas Moore, a drug-safety researcher, called for the unsealing of thousands of Pfizer Inc. internal documents, National Law Journal reports. Both wrote about how smoking cessation treatments like Chantix are associated with a higher incidence of depression, suicide and violence toward other people. The two experts “want to ensure the public debate about the psychiatric side effects of Chantix includes a balanced scientific record, which was examined in depth in the Chantix litigation,” according to court documents. The FDA meeting is scheduled for Oct. 16. Continue reading
Exxon Mobil’s attempt to de-certify the class action status of a couple’s lawsuit should be denied, the couple’s attorney argued. According to Arkansas Democrat Gazette, a federal judge granted class action status to the lawsuit, which was filed over an oil spill in Mayflower. Exxon Mobil has petitioned to appeal this decision. Continue reading
The U.S. Food and Drug Administration (FDA) has stated that the exact health effects of e-cigarettes remain unknown. E-cigarettes provide a different nicotine delivery system that, instead of providing smoke, provides vapor.
Not unexpectedly, the makers of e-cigarettes argue that their products are safer than traditional cigarettes; however, the FDA has questions concerning the fairly new nicotine products, according to Daily News Journal. “While e-cigarette aerosol may contain fewer toxicants than cigarette smoke, studies evaluating whether e-cigarettes are less harmful than cigarettes are inconclusive,” the FDA indicated in a recent report. The agency also questioned claims that e-cigarettes may be of help in smoking cessation, indicating in the report that, “No e-cigarette has been approved by FDA as a cessation aid.” Continue reading
Device maker St. Jude Medical has halted implantation of the Portico transcatheter aortic valve replacement (TAVR) over safety concerns that surfaced in U.S. clinical trials.
The Portico TAVR device is intended for patients with severe aortic stenosis (narrowing) who are at high risk for open-heart valve replacement surgery or who cannot have surgery. In an email to Medscape, the company confirmed that it had halted implantation worldwide while evaluating “recent cases of reduced valve leaflet mobility that were reported from a small number of CT scans performed approximately 30 days after implant in the U.S. IDE [investigational device exemption] study.” Continue reading
On Monday, a DePuy executive was questioned about whether or not the company properly analyzed the dangers of the metal-on-metal Pinnacle hip implant. According to Reuters, Depuy worldwide vice president of clinical research Pamela Plouhar took the stand in the bellwether trial.
There are over 6,000 Pinnacle lawsuits consolidated in Dallas federal court. The first to go to trial was filed on behalf of a 58-year old Montana woman who received two metal-on-metal versions of the Pinnacle hip implant in 2009. Her lawsuit, filed in 2012, alleges that the defective devices released cobalt into her bloodstream and caused it to jump up to 85 times the normal level. Continue reading
According to a systematic review published online September 9th in the BMJ, there is no evidence to support the use of 5 newer joint replacement devices compared to analogous products that have been on the market longer. In fact, the risk of undergoing revision surgery is higher with some of the newer systems.
The study was led by Marc J. Nieuwenhuijse, MD, PhD from the Patient Centered Comparative Effectiveness Program and US Food and Drug Administration Medical Device Epidemiology Science and Infrastructure Center, Department of Public Health, Weill Cornell Medical College, New York, City; the Department of Orthopaedics, Leiden University Medical Center, the Netherlands; and the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD. He and his colleagues wrote that “[N]ew technologies are being introduced to the commercial market without sufficient high quality evidence for improved benefit over existing, well proven, and safe alternative implant solutions…[T]he status quo regarding the introduction of new device technologies is not acceptable.” Continue reading
Kenneth Feinberg, the attorney overseeing the General Motors compensation fund, has so far linked 19 deaths to a serious flaw with the ignition switches, a higher number than the 13 deaths GM had acknowledged in crashes resulting from the switch problem.
The fund has received 125 death claims and 320 injury claims in the five weeks it has been operating. Feinberg has found 31 claims eligible for compensation, CNN Money reports. Continue reading