Health Highlights: June 3, 201306/03/13
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
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 Timesreported.
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,
Angelina Jolie Makes First Public Appearance Since Double
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
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
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,
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,
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
The New York Timesreported.
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
Age-Based Lung Transplant Rules Need to be Reviewed: HHS
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,
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 Newsreported. "We strongly believe Sarah should be triaged based on the severity of her illness, not her age."
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