Bush Orders Review of U.S. Military and Veteran Hospitals
U.S. President George W. Bush on Friday ordered a thorough review of conditions at all American veteran and military hospitals. The review was prompted by revelations about poor care for wounded troops at Walter Reed Army Medical Center in Washington, D.C.
Bush will name a bipartisan commission to investigate whether the problems uncovered at Walter Reed are also present at other facilities, the Associated Press reported.
On Thursday, the Pentagon said it had fired Walter Reed commander Army Maj. Gen. George W. Weightman. The situation at Walter Reed was made public by The Washington Post, which found that bureaucratic issues prevented many troops from receiving adequate care and that some outpatients were enduring squalid living conditions, the AP reported.
The commission to be appointed by Bush will be separate from a panel named by Defense Secretary Robert Gates to study outpatient care at Walter Reed and the National Naval Medical Center in Bethesda.
FDA Outlines Approach to Informing Public About Drug Safety
The U.S. Food and Drug Administration on Friday issued final guidance on the agency's approach to communicating drug safety information to the public and the factors that influence when drug safety information is given to the public.
The FDA said the guidance affirms the agency's commitment to provide important drug safety information in a timely manner through: public health advisories; patient information sheets; health care professional information sheets; and alerts posted on public health advisories and patient and health care professional sheets. These are all available through the FDA Web site.
Drug product labeling is another method of providing the public and health professionals with important drug safety information, the FDA said.
"Our goal is to make emerging drug safety information available in a balanced, impartial manner so that health care professionals and patients can consider the information when making decisions about medical treatments despite uncertainties in the data," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.
Create Global Bird Flu Stockpile: WHO Official
A global stockpile of bird flu vaccine needs to be established in order to help guarantee that poor countries have access to vaccine if a global pandemic erupts, the World Health Organization's leading flu official said Friday.
Currently, up to 500 million doses of bird flu vaccine can be produced, which is far below what would be needed if bird flu starts to infect large numbers of people around the world, the Associated Press reported.
A number of developing countries fear they won't be able to get the vaccine if there is a pandemic, said Dr. David Heymann. He suggested the creation of a "virtual" stockpile, where richer countries agree to donate a percentage of their vaccine supplies to poorer nations if there is a pandemic.
"What we need to do and want to do is develop mechanisms that will permit countries to have access to vaccines if they need it," Heymann told the AP.
That would cover the short term. The long-term goal is to provide developing nations with the technology and expertise to produce their own vaccines, he said.
FDA Warns 20 Companies About Illegal Migraine Drugs
Twenty drug companies have been sent warning letters that they're selling unapproved and potentially dangerous migraine medicines, the U.S. Food and Drug Administration said Thursday.
The illegal prescription medicines contain ergotamine tartrate, which is derived from a rye fungus called ergot. Ergotamine is a vasoconstrictor, which means that it narrows blood vessels, the Associated Press reported.
Labeling on these unapproved drugs doesn't warn consumers about potentially dangerous interactions if the medicines are taken with other drugs, including some HIV medicines, anti-fungal agents and antibiotics, the FDA said.
"Because these drugs don't have approval, we don't know how they were formulated or manufactured. We don't know if they are safe or effective," Deborah Autor, director of the office of compliance at the FDA's Center for Drug Evaluation and Research, told reporters.
Companies that received the warning letters included: a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. of Israel, the world's largest manufacturer of generic drugs; Actavis of Iceland; and Sandoz Inc., part of the Swiss company Novartis AG.
In the warning letters, the FDA told the companies that they have 60 days to stop making the drugs and 180 days to halt distribution. If they don't meet the demands, the companies will be subject to seizure or injunction, the AP reported.
The FDA told the companies that they could seek agency approval for the drugs.
Raw Milk Poses Health Risks: FDA and CDC
Raw (unpasteurized) milk can contain a wide variety of harmful bacteria that can cause illness and even death, the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration said in a reminder to consumers.
Between 1998 and May 2005, the CDC identified 45 outbreaks of foodborne illness linked to unpasteurized milk or cheese made from unpasteurized milk. In those outbreaks, 1,007 people became ill, 104 were hospitalized, and two died. It's likely that the actual number of illnesses was higher, because not all cases of illness are recognized and reported, the CDC said.
Symptoms of illness caused by raw milk vary, depending on which kind of harmful bacteria are present in the milk. Symptoms may include vomiting, diarrhea, abdominal pain, fever, headache and body ache.
Proponents of raw milk contend that it's more nutritious than pasteurized milk and that raw milk is inherently antimicrobial, which makes pasteurization unnecessary. Research has found no evidence to support these claims, the FDA and the CDC said.
Since 1987, the FDA has required the pasteurization of all milk and milk products (with the exception of a few aged cheeses) produced for human consumption.
FDA Panel Rejects Implantable Heart Failure Monitor
An implantable device designed to detect worsening heart failure should not receive U.S. federal approval, a panel of Food and Drug Administration advisers recommended Thursday.
They voted 9-2 against the Chronicle Implantable Hemodynamic Monitor, made by Medtronic Inc. of Minneapolis, Minn. A study of the device suggested that it wasn't effective, the Associated Press reported.
While the FDA is not obligated to follow the advisory committee's recommendation, the agency usually does so.
Medtronic's device records data on heart rate, temperature, pressure and patient activity. This information can be downloaded by doctors or securely transmitted to the Internet for viewing, the AP reported.
The company is currently studying a defibrillator that incorporates the same monitoring technology.