Health Highlights: June 5 2015
New Cholesterol-Lowering Drug Being Considered by FDA 'Dr. Oz Show' Hires New Medical Unit Chief of Staff NIH Pharmacy Closed After Fungal Contamination Found First Skull/Scalp Transplant Performed by Texas Doctors
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New Cholesterol-Lowering Drugs Being Considered by FDA
An experimental drug lowers bad cholesterol more than older types of drugs, but the U.S. Food and Drug Administration is uncertain about whether to approve the drug based on that benefit alone or to wait for more clinical trial results.
Sanofi's Praluent is the first in a new class of cholesterol-lowering biotech drugs to be considered by the FDA. Company studies showed that patients who took Praluent in addition to older cholesterol-lowering statin drugs had 46 to 60 percent reductions in bad cholesterol, compared with 20 to 22 percent for patients who took a statin alone, the Associated Press reported.
An FDA advisory group is scheduled to meet next week to discuss the drug and decide whether to recommend FDA approval. The agency typically follows the advice of its advisory panels
In a review posted Friday, the FDA said it wasn't sure whether to approve Praluent based on its cholesterol-lowering benefits or wait for completion of longer-term studies meant to determine if the drug actually reduces heart attack and death in patients. Those results aren't expected until 2017, the AP reported.
At its meeting next week, the advisory panel will also review a similar drug, Repatha from Amgen Inc.
The new class of drugs are regarded as the first major advance in cholesterol-lowering medications since statins were introduced in the late 1980s, the AP reported.
'Dr. Oz Show' Hires New Medical Unit Chief of Staff
A physician who was with Consumer Reports has been hired to be chief of staff of the medical unit for "The Dr. Oz Show."
Dr. Michael Crupain will head the unit, which performs duties such as evaluating expert guests and researching and verifying scripts. Show officials also said Crupain will increase liaisons with the medical community, the Associated Press reported.
Prevoiusly, Crupain was director of Consumer Reports' Food Safety and Sustainability Center.
Recently, a group of doctors accused Dr. Mehmet Oz of promoting "quack treatments" on the show. Oz said the doctors' attack was prompted by his support for labeling of genetically modified foods, the AP reported.
NIH Pharmacy Closed After Fungal Contamination Found
Operations have been halted at a specialized pharmacy at the U.S. National Institutes of Health's clinical center in Bethesda, Md. after fungus was discovered in fluid used in clinical studies, officials said Thursday.
The fungus in two vials of albumin -- used to administer the drug interleukin -- was discovered in April, The New York Times reported.
Six patients received albumin from the same batch, but it's not clear if there was fungus in the vials they received. They were notified and are being closely monitored, but no signs of illness have been seen in any of them, according to the NIH.
After receiving a complaint, Food and Drug Administration inspectors spent 10 days last month examining the specialized pharmacy, which makes medicines and other products for clinical research studies, The Times reported.
The FDA inspectors found a number of irregularities and "serious manufacturing problems," the NIH said.
For example, the inspectors said protective gear was not worn properly and witnessed one worker processing supposedly sterile drugs while his facial was uncovered and with an exposed wrist due to a gap between his gown and glove, The Times reported.
The FDA team also flagged "inadequate separation" between the area where the drugs were mixed and the "common pharmacy" area, quality control problems, and non-compliance with standard operating procedure.
Forty-six studies have been affected and the NIH is trying to find alternative sources for the approximately 250 patients in those studies who were to have received products from the pharmacy, The Times reported.
"The fact that patients may have been put in harm's way because of a failure to follow standard operating procedures in the NIH Clinical Center's Pharmaceutical Development Section is deeply troubling," NIH Director Dr. Francis Collins said in a statement.
This is the latest in a series of recently revealed mistakes made by government laboratories. Earlier this week, the Defense Department said it accidentally sent suspected live samples of anthrax to at least 51 laboratories in 17 states and three other countries.
Last July, vials of smallpox and other infectious agents were found in an NIH lab where they had been stored and forgotten for decades, The Times reported.
First Skull/Scalp Transplant Performed by Texas Doctors
The world's first partial skull and scalp transplant was performed by doctors at the MD Anderson Cancer Center and Houston Methodist Hospital in Texas.
The patient -- 55-year-old Jim Boysen of Austin -- had a large head wound from cancer treatment. The surgery took place May 22 and Boysen was expected to leave the hospital on Thursday, the Associated Press reported.
He was amazed at how well the new skin and coloring matches his own.
"It's kind of shocking, really, how good they got it. I will have way more hair than when I was 21," Boysen told the AP.
Last year, doctors in the Netherlands used a 3-D printed plastic replica to replace most of a woman's skull. Boysen is believed to be the first person to receive a skull-scalp transplant from a human donor, rather than an artificial implant or simple bone graft.