Friday, August 11, 2006

Health Headlines - August 11

Pharmacies Warned to Stop Mass Sales of Compounded Inhaled Drugs

The U.S. Food and Drug Administration has warned three pharmacies -- RoTech Healthcare Inc., CCS Medical, and Reliant Pharmacy Services -- to stop mass producing and distributing compounded, unapproved inhalation drugs.

Compounding typically involves the small-scale custom preparation by pharmacies of drugs that are not commercially available. This is done following a doctor's decision that a patient has a special need that can't be met by FDA-approved drugs. This type of practice often is permitted by the FDA.

Inhalation drugs are used to treat diseases such as asthma, emphysema, bronchitis, and cystic fibrosis. There are many FDA-approved drugs to treat these conditions.

However, the FDA said that it's aware of some pharmacies that compound millions of doses of inhalation drugs each year. The agency warned that patients and doctors may not know what's contained in these mass-produced drugs.

"Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk. To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

Problems associated with compounded drugs should be reported to the FDA at 1-800-FDA-1088.

Report Describes U.S. Underage Binge Drinking Patterns

Rates of underage binge drinking in the Unites States are highest in parts of Washington, D.C., North Dakota and South Dakota, Montana, Rhode Island, and Wisconsin, says a report released Thursday by the federal Substance Abuse and Mental Health Services Administration (SAMHSA).

The lowest rates of underage binge drinking are in other portions of Washington, D.C, and in areas of Detroit, Los Angeles, Utah, Tennessee, Maryland, Mississippi, Florida, and Georgia.

The data was collected during national surveys done from 2002 to 2004. Binge drinking is defined as having five or more drinks within a couple of hours at least once in the previous 30 days.

Thirteen of the 15 areas that had the highest rates for underage binge drinking also had the highest rates of underage alcohol use.

"We have made real progress in convincing young people to abstain from drug use. Now we need to have the same positive results with alcohol abuse and dependence," Assistant Surgeon General Eric Broderick, SAMHSA's acting administrator, said in a prepared statement.

Proteins That Weaken With Age Contribute to Alzheimer's: Study

Two proteins -- HSF-1 and DAF-16 -- that get rid of excess amounts of a sticky protein called beta-amyloid in the brain appear to become less effective with age, says a U.S. study in the journal Science.

Clumps of beta-amyloid in the brain are a hallmark of Alzheimer's disease. The study provides a molecular connection between aging and Alzheimer's, experts said.

The findings suggest that using drugs to help boost the cleanup efforts of HSF-1 and DAF-16 may offer a new way of fighting Alzheimer's, the Associated Press reported.

"It's a whole new way of thinking in the Alzheimer's field," said lead researcher Dr. Andrew Dillin, a biologist at California's Salk Institute for Biological Studies.

He and others at the Scripps Research Institute are already searching for potential drug candidates, the AP reported.

U.S. Expands Bird Flu Monitoring in Wild Birds

The United States is expanding its monitoring for bird flu in wild migratory birds to cover the entire country and American territories in the Pacific, federal officials said.

Expanded testing for the H5N1 bird flu virus will be conducted by scientists in the lower 48 states, Hawaii and other Pacific Islands, the Associated Press reported. Monitoring for bird flu in wild birds began in Alaska just before the start of summer.

"This move to test thousands more wild birds throughout the country will help us to quickly identify, respond and control the virus if it arrives in the United States. Because we cannot control wild birds, our best protection is an early warning system," said Agriculture Secretary Mike Johanns.

It's expected that feces or tissue samples will be collected from 75,000 to 100,000 wild birds. In addition, about 50,000 samples will be taken from ground and water where the birds gather.

Test sites are likely to include national and state parks and wildlife refuges, city parks and ponds, and private lands where owners have given permission, the AP said.

Rights Group Opposes Coercive HIV Testing

Saudi Arabia and India are among a number of countries violating civil liberties by adopting coercive policies for HIV testing, alleges the group Human Rights Watch. HIV is the virus that causes AIDS.

A press release issued by the New York-based group said an increasing number of nations are either proposing or using mandatory or discriminatory HIV test programs that often fail to ensure confidentiality, Agence France Presse reported.

The fear and stigma associated with these kinds of programs may make people try to avoid testing and contribute to the spread of HIV, the group said. The release was issued a few days before Sunday's start of the 16th International AIDS Conference in Toronto.

"There is little or no evidence that HIV testing by itself has any impact on this deadly epidemic. But voluntary HIV testing programs that respect rights, ensure confidentiality and are linked to counseling and treatment have been enormously successful," said Joe Amon, head of the HIV/AIDS section of Human Rights Watch.

One state in India has proposed mandatory pre-marital testing for HIV, while another state proposed HIV testing for all people seeking or holding a driver's license, AFP reported.

United Nations' organizations including the World Health Organization and UNAIDS must update their guidelines to clearly state that HIV testing should be linked to counseling and medical care, Human Rights Watch urged.

Medicare Weighs Cuts to Doctors' Reimbursement Rates

Medicare reimbursement rates for doctors could decrease by about 5 percent in 2007, a cut that U.S. physicians say could make it more difficult for elderly patients to see a doctor, the Associated Press reported.

The Centers for Medicare and Medicaid Services will soon issue new regulations to update reimbursement rates for next year, agency administrator Mark McClellan told reporters this week. But he didn't provide an exact figure on the proposed rate change.

However, trustees for the Medicare program projected in May that there would be a 4.7 percent decrease, the AP reported.

The proposed reductions are due to a "vicious cycle" in health care, McClellan said. As doctors provide more and more services per patient, Medicare spending increases faster than the overall economy.

But the proposed rate reductions may be blocked by Congress, the AP reported.

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