Health Highlights: Aug 28 2015
Plague Death in Utah Under Investigation FDA Sends Warning Letters to 3 Cigarette Companies Over 'Natural,' 'Additive-Free' Claims FDA Issues Proposals on Lower-Cost, Generic Biotech Drugs Critics Condemn Medicare Artificial Limb Coverage Changes First Child to Have Double Hand Transplant Goes Home
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Plague Death in Utah Under Investigation
Utah health officials are investigating the death of an elderly person from plague this month. They did not provide any details about the person.
It's the first human case of plague in Utah since 2009, according to the Department of Health's JoDee Baker, CNN reported.
The investigation is looking into how, where and when the person was infected with plague. It is known that the person did not travel to an area where plague is common.
So far this year, 12 cases of plague in people have been diagnosed in seven states, and four of the patients have died, CNN reported.
People typically become infected after being bitten by a flea from an infected rodent such as a rat, squirrel or chipmunk. Symptoms usually appear two to six days after exposure.
Treatment with antibiotics can be successful if patients are diagnosed and treated early, CNN reported.
Earlier this week, the U.S. Centers for Disease Control and Prevention said the number of cases of plague is higher than usual this year, and told doctors to be on the alert for possible cases of the disease.
FDA Sends Warning Letters to 3 Cigarette Companies Over 'Natural,' 'Additive-Free' Claims
Three tobacco companies have been sent warning letters for making "additive-free" and/or "natural" claims on cigarette labels, the U.S. Food and Drug Administration said Thursday.
The warning letters were issued to ITG Brands LLC for Winston cigarettes labeled additive-free, Santa Fe Natural Tobacco Company Inc. for Natural American Spirit cigarettes labeled additive-free and natural, and Sherman's 1400 Broadway N.Y.C. Ltd. for Nat Sherman cigarettes labeled natural.
This is the first time the FDA has used authority gained in 2009 to take action over the use of additive-free or natural claims on the labels of tobacco products.
"The FDA's job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like 'additive-free' and 'natural' pose fewer health risks than other cigarettes, unless the claims have been scientifically supported," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in an agency news release.
"This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use," he added.
The companies have 15 working days to respond to the warning letters and explain what they will do to correct the violations, or to challenge them. If the companies don't follow federal tobacco laws, the FDA can take further action, such as fines, seizure, injunctions or criminal prosecution.
FDA Issues Proposals on Lower-Cost, Generic Biotech Drugs
A proposal for identifying lower-cost generic biotech drugs has been released by the U.S. Food and Drug Administration.
Many newer biotech drugs cost more than $10,000 a year and this class of drugs accounts for nearly 30 percent of all drug spending in the country, according to the Associated Press.
For decades, there have not been any generic versions of biotech drugs because the FDA did not have a system to approve generic versions until 2012. But earlier this year, the agency approved the first "biosmilar" drug, the term for generic biotech drugs.
Under the FDA proposal, all biotech drugs would carry a four-letter code to help doctors and pharmacists distinguish brand name and generic versions, the AP reported.
Public comments on the proposal will be accepted for 60 days before the FDA moves to finalize the rule.
Generic biotech drugs have been available in Europe since 2006 and about have been 20 approved there, the AP reported.
Critics Condemn Medicare Artificial Limb Coverage Changes
Medicare's proposed new coverage requirements for artificial legs and feet are facing strong opposition.
The proposals include closer medical supervision of the independent technicians who sell and fit artificial limbs, and stricter rules about who qualifies for the devices, which can cost as much as a car, the Associated Press reported.
Critics say the new rules will lead to a lower quality of life for amputees if they are denied the most advanced artificial limbs.
The campaign against the proposed Medicare changes is spearheaded by an industry group called the American Orthotic & Prosthetic Association and a coalition of amputees, the AP reported.
A statement released by Medicare states the agency believes "beneficiaries will continue to have access to lower-limb prosthetics that are appropriate" and adds that the payment overhaul "is not meant to restrict any medically necessary prosthesis."
First Child to Have Double Hand Transplant Goes Home
The first child to receive a double hand transplant is making good progress and has returned home, doctors say.
Zion Harvey, 8, lost his arms and legs to a severe infection at age 2. He received his new hands during an 11-hour operation in early July at Children's Hospital of Philadelphia and since has been doing physical and occupational therapy several times a day, NBC News reported.
He has made significant progress and went home from the hospital on Wednesday.
"He's just a remarkable lad. Today he was playing with his action figures and baking cookies with a whisk, doing all sorts of things with his hands we never dreamed he would be able to do within a few weeks of surgery," transplant team lead surgeon Dr. Scott Levin told NBC News.
"The challenges facing Zion are new, but his determination should overcome them. He's already done so many amazing things," Zion's mother Pattie Ray said in a statement.
Since the announcement of Zion's transplant, the hospital has received nearly 200 inquires from around the world, and the transplant team has already screened another child candidate for a double hand transplant, NBC News reported.