Health Highlights: Aug. 7, 2019
U.S. Army Lab Halts Germ Research Due to Safety Concerns Patient Who Caught Legionnaires' Disease at Atlanta Hotel Dies FDA Says Approval of World's Priciest Drug Was Based on Manipulated Data
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
U.S. Army Lab Halts Germ Research Due to Safety Concerns
Research involving Ebola and other deadly microbes has been halted at a U.S. Army lab due to safety concerns.
A "cease and desist order" to stop research at the lab in Fort Detrick, Md. was issued last month by the U.S. Centers for Disease Control and Prevention because the lab did not have "sufficient systems in place to decontaminate wastewater" from its highest-security labs, The New York Times reported.
"Research is currently on hold," the United States Army Medical Research Institute of Infectious Diseases said in a statement on Friday.
The shutdown is likely to last months, spokeswoman Caree Vander Linden told The Times.
She said there has been no threat to public health, no injuries to employees and no leaks of dangerous material outside the laboratory.
The statement said "national security reasons" prevented the CDC from releasing information about its decision to halt germ research at the lab, The Times reported.
Patient Who Caught Legionnaires' Disease at Atlanta Hotel Dies
One of the 12 people diagnosed with Legionnaires' disease after staying at the Sheraton Atlanta hotel in early July has died, officials said.
Another 61 probable cases of the disease have been identified, according to Nancy Nydam, director of communications at Georgia Department of Public Health, CNN reported.
The hotel has not been confirmed as the source of the outbreak of the serious form of noncontagious pneumonia, but voluntarily closed and is working with public health officials and environmental experts investigating the situation.
The hotel will remain closed until at least Aug. 11, Ken Peduzzi, the hotel's general manager, said in a statement Tuesday,CNN reported.
Between 10,000 and 18,000 people get Legionnaires' disease each year in the U.S., and about one in 10 will die, according to a recent U.S. government report. Legionnaires' disease is caused by bacteria and can be treated with antibiotics, according to the U.S. Centers for Disease Control and Prevention.
FDA Says Approval of World's Priciest Drug Was Based on Manipulated Data
The maker of the world's most expensive drug gave manipulated data to the U.S. Food and Drug Administration when it approved the drug, the agency said Tuesday.
In late May, the FDA approved the gene therapy Zolgensma to treat children with a severe form of spinal muscular atrophy, a leading genetic cause of infant death. The drug costs $2.125 million for a one-time treatment, CBS News reported.
A month after the approval, the FDA discovered a "data manipulation issue that impacts the accuracy of certain data from product testing performed in animals," according to the agency.
The FDA said the drug's maker AveXis, a unit of Novartis, knew about the data problem before the drug was approved, but did not inform the FDA until after the drug was given the green light, CBS News reported.
"The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties," according to Peter Marks, an FDA official.
Despite the inaccurate data, the FDA said it "remains confident that Zolgensma should remain on the market."
"We maintain that the totality of the evidence demonstrating the product's effectiveness and its safety profile continue to provide compelling evidence supporting an overall favorable benefit-risk profile," Novartis said in an emailed statement, CBS News reported.
"At no time during the investigation did the findings indicate issues with product safety, efficacy or quality," according to the company.