Health Highlights: July 17, 2014
Fedex Corp. Charged With Illegal Delivery of Drugs Without Prescriptions New Hepatitis C Drug a $55 Billion Burden for States: Study New Drug Approved for Rare Disease That Causes Sudden Swelling CDC Lacks 'Culture of Safety': Director
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Fedex Corp. Charged With Illegal Delivery of Drugs Without Prescriptions
The U.S. Justice Department announced Thursday that it has filed charges against Fedex Corp. that claim the mail distribution company helped two related online pharmaceutical companies to deliver painkillers and dangerous drugs without prescriptions.
The charges, which were filed in federal court in San Francisco, allege that the conspiracy continued for a decade, ending in 2010, the Associated Press reported. Federal authorities want the Memphis, Tenn.-based company to turn over more than $800 million it earned from the deliveries.
The drugs that Fedex is accused of mailing include the sleeping pill Ambien and the anti-anxiety medications Valium and Xanax, according to the wire service.
FedEx claims it handles 10 million packages a day and shouldn't be "assuming criminal responsibility" for every delivery it makes, the AP reported.
"We will plead not guilty. We will defend against this attack on the integrity and good name of FedEx and its employees," company spokesman Patrick Fitzgerald said in a statement.
However, federal officials claim they have been telling FedEx since 2004 that it was shipping dangerous drugs without prescriptions, according to the AP.
UPS Inc. paid $40 million last year to resolve similar allegations, and the Atlanta-based company said at the time it would "take steps" to block illicit online drug dealers from using its delivery service, the wire service reported.
New Hepatitis C Drug a $55 Billion Burden for States: Study
It could cost state Medicaid programs more than $55 billion to pay for a breakthrough drug to treat hepatitis C, according to a study by pharmacy benefits firm Express Scripts.
The drug, Sovaldi, costs $1,000 a day for a 12-week treatment, even with a 23 percent Medicaid plan discount, CNBC reported.
Nationwide, more than 750,000 Medicaid patients and prisoners covered by state health programs have chronic hepatitis C, which can lead to liver cancer. States facing the largest bills for hepatitis C spending include California ($6.7 billion), Texas ($5.3 billion), and Florida and New York (nearly $4 billion each), according to Express Scripts.
The cost of treating hepatitis C is a huge burden for state health systems, Dr. Steve Miller, Express Scripts medical director, told CNBC.
"These states are saying 'What is it we're supposed to do?'" Miller said. "This is just unimaginable for state budgets today."
New Drug Approved for Rare Disease That Causes Sudden Swelling
A new drug to treat a rare but potentially life-threatening genetic disease called hereditary angioedema (HAE) has been approved by the U.S. Food and Drug Administration.
HAE, which affects 6,000 to 10,000 people in the U.S., is caused by insufficient amounts of a plasma protein called C1-esterase inhibitor. People with the disease can develop sudden swelling of the hands, feet, limbs, face, intestinal tract, or airway.
These attacks of swelling can occur on their own or be triggered by stress, infection or surgery. Without immediate treatment, swelling of the airway can be deadly.
The newly-approved drug for HAE is called Ruconest. It is designed to restore the normal level of C1-esterase inhibitor in a patient's plasma in order to treat sudden attacks of swelling, the FDA said.
The approval is based on a study of 44 adults and teens with HAE whose swelling attacks were treated with Ruconest. Common side effects caused by the drug included headache, nausea and diarrhea.
The drug is made by Pharming Group NV of the Netherlands and will be distributed in the U.S. by Santarus Inc., a subsidiary of Salix Pharmaceuticals Inc.
CDC Lacks 'Culture of Safety': Director
Recent safety lapses at the U.S. Centers for Disease Control and Prevention -- such as the mishandling of live anthrax and accidental contamination of specimens with a dangerous bird flu strain -- show that the agency lacks a "culture of safety," CDC Director Tom Frieden said Wednesday.
Meanwhile, the U.S. Food and Drug Administration delivered disturbing news of its own as Frieden concluded his testimony before Congress on the CDC incidents.
In addition to finding six forgotten vials of smallpox virus recently, more than 300 other sealed vials containing biological materials such as dengue, influenza, Q fever, ricksettsia and other possible unknown viruses were found in the same cold storage room on the U.S. National Institutes of Health campus.
A sweep of all cold storage facilities has been ordered, USA Today reported.
FDA officials noted that the other pathogens listed on the additional vials do not pose the same threat as smallpox, the newspaper said.
In his testimony, CDC Director Frieden said the anthrax incident at his agency "was completely unacceptable. It should never have happened," USA Today reported.
"With the recent incidents, we recognize a pattern at CDC where we need to greatly improve the culture of safety," Frieden told an oversight committee of the House Comittee on Energy and Commerce. "What we're seeing is a pattern that we missed, and the pattern is an insufficient culture of safety."
Frieden said he is personally in charge of efforts to improve safety, such as closing two labs involved in two recent high-profile errors, the appointment of a senior scientist to be the single official in charge of lab safety, and suspending the transfer of biologic specimens from all the CDC's biosafety level 3 and 4 labs, USA Today reported.
However, U.S. Rep. Fred Upton, R-Mich., noted that many of the measures sound like remedies the CDC said it made two years ago after the committee investigated safety issues at a CDC lab complex.
"Why should we believe this time things will be different?" Upton asked, USA Today reported.