Health Highlights: June 3, 2013
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
No Misconduct or Fraud in Avandia Study: FDA
A review found no serious misconduct or fraud in a controversial clinical trial that minimized safety issues involving the diabetes drug Avandia, according to U.S. Food and Drug Administration experts.
The FDA team said they supported the findings of the review by Duke University researchers, who determined that any errors made by drug maker GlaxoSmithKline had no effect on the conclusions of the company's clinical trial of Avandia, The New York Times reported.
The FDA experts' opinion was posted Monday on the FDA website, along with a critical memo by FDA scientist Dr. Thomas Marciniak, who originally raised concerns about the Glaxo study. Marciniak questioned whether the review by the Duke researchers was truly objective because it was financed by Glaxo.
In 2010, the FDA imposed tight restrictions on the use of Avandia after several analyses showed that the drug significantly increased the risk of heart attack. The drug was removed from the market in Europe.
The conflicting viewpoints were posted on the FDA website in advance of a two-day meeting of an FDA advisory panel scheduled to begin Wednesday. The panel will discuss the issue and recommend to the FDA whether to widen access to Avandia, keep the current restrictions in place, or take the drug off the market, The Times reported.
Angelina Jolie Makes First Public Appearance Since Double Mastectomy
In her first public appearance since undergoing a double mastectomy, Angelina Jolie told reporters she felt great and had "been very happy to see the discussion about women's health expanded" after her announcement about the surgery.
Jolie and husband Brad Pitt -- who appeared together Sunday at the premiere of Pitt's new movie called "World War Z" -- said they were moved by the outpouring of public support for the 37-year-old actress, the Associated Press reported.
In an op-ed article published last month in The New York Times, Jolie revealed that she had her breasts removed after she learned that she had an inherited genetic mutation that greatly increased her risk of breast and ovarian cancer. The procedure reduced her chance of developing breast cancer from 87 percent to under 5 percent, according to Jolie.
Her mother Marcheline Bertrand died from ovarian cancer at age 56 and her aunt died of breast cancer last month, the AP reported.
Frozen Berry Mix Linked to Hepatitis A Outbreak
A frozen berry and pomegranate seed mix sold by Costco has been linked to an outbreak of acute hepatitis A that has sickened at least 30 people in Colorado, New Mexico, Nevada, Arizona and California, federal health officials say.
The first victims became ill on April 29 and the most recent case was May 17, according to a Centers for Disease Control and Prevention news release issued Friday. The CDC believes there will be more cases, USA Today reported.
A product called The Townsend Farms Organic Anti-oxidant Blend Frozen Berry Mix appears to be linked to the outbreak, officials said. Costco has removed the product from it shelves and notified all customers who purchased it since late February.
It's not yet known if the product was sold at other stores or markets, health officials said. But they noted that frozen berry blends are often used to make smoothies, frozen bar drinks and other types of drinks and desserts. They are concerned that smaller businesses might have bought bulk amounts of the frozen berry mix at Costco and used it in other products, USA Today reported.
Cancer Drug Avastin Does Not Extend Lives of Patients With Deadly Brain Cancer: Studies
The cancer drug Avastin does not prolong the lives of patients with a deadly form of brain cancer called glioblastoma, according to two new studies.
The findings could lead the U.S. Food and Drug Administration to revoke Avastin's approval for treatment of this type of brain cancer, as it did in 2011 with the drug's approval for breast cancer, The New York Times reported.
The two studies were presented this weekend at the annual meeting of the American Society of Clinical Oncology. Despite the findings, the low number of treatment options for patients with glioblastoma means that the FDA is unlikely to revoke Avastin's approval for treatment of the brain cancer.
"The vast majority of patients with glioblastoma in the United States get Avastin at some point in their illness," Dr. Mark Gilbert, of the University of Texas M.D. Anderson Cancer Center, told The Times. He was the lead investigator in one of the studies.
The FDA considers "the totality of the evidence" when assessing drugs and has "approved a lot of drugs without a survival advantage," Dr. Richard Pazdur, head of the FDA's cancer drug division, told The Times.
Age-Based Lung Transplant Rules Need to be Reviewed: HHS Secretary
An age-based policy that forces some seriously-ill children to wait for lung transplants needs to be reviewed, U.S. Healthy and Human Services' Secretary Kathleen Sebelius says in a letter sent to the Organ Procurement and Transplantation Network.
She made the request as the parents of a 10-year-old Pennsylvania girl fight to save their daughter's life. Sarah Murnaghan has cystic fibrosis and only has weeks to live if she doesn't receive a lung transplant, ABC News reported.
The current policy states that lungs from adult donors must be offered to all adult patients before they can be offered to someone younger than age 12.
"We are not asking for preference for Sarah, we are asking for equality," Sarah's mother, Janet Murnaghan, said in a news release, ABC News reported. "We strongly believe Sarah should be triaged based on the severity of her illness, not her age."Related Articles
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