Health Highlights: Dec. 28, 2005

U.S.: Climate of Fear Plagued L.A. Liver Transplant Program Americans Are More Miserable, Survey Finds New Treatment Sanctioned for Bone Marrow Disorder Defibrillator Maker Gets FDA Warning China to Produce 1 Billion Doses of Avian Flu Vaccine

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

U.S.: Climate of Fear Plagued L.A. Liver Transplant Program

The liver transplant program at St. Vincent Medical Center in Los Angeles was plagued by a climate of "fear and retribution" that prevented staffers from revealing the program's serious inadequacies, according to a federal report cited by the Los Angeles Times on Wednesday.

The 99-page report by the U.S. Centers for Medicare and Medicaid Services found that the hospital did not comply with eight conditions required by hospitals receiving federal funding, the newspaper said. Based on hospital records, there was no proof that some patients received a physical examination or, in some cases, were even reviewed by a selection committee before being added to the transplant list, the Times reported.

St. Vincent closed its liver transplant program following its admission in September that its doctors had improperly arranged for a September 2003 transplant to a Saudi man using an organ that was supposed to have gone to a person who was higher on the hospital's priority list.

The transplant was not revealed until two years later when the hospital was responding to a routine audit, the newspaper said.

The hospital acknowledged that a number of staff members knew about the incident but "participated in [an alleged] coverup," the Times reported. "One staff member stated that the transplant director at the time had a 'my way or the highway' attitude that prevented staff from raising any concerns," the newspaper said.

Inspectors cited several instances "in which transplant staff members said they were asked to falsify documents," the Times reported.

The hospital said it has taken corrective action that included establishing a transplant committee that reports to the hospital's governing board, providing additional training to transplant team members, and creating a hotline for workers concerned about medical quality, the newspaper said.


Americans Are More Miserable, Survey Finds

In this season of what's supposed to be comfort and joy, a new University of Chicago poll suggests that many Americans are more miserable now than they were 15 years ago.

More Americans are reporting incidents of illness, inability to afford medical care, and unstable romantic relationships than when the school's National Opinion Research Center conducted its first "Negative Life Events" survey nearly 15 years ago, the school said in a statement.

Seventeen percent of this year's respondents said they had been a patient in a health-care facility, versus 14 percent in 1991. Eleven percent said they couldn't afford needed medical care, compared with 7 percent in 1991, and 18 percent said they lacked health insurance, compared with 12 percent in the earlier poll.

Nearly 7 percent in the most recent survey said they were separated from a partner, compared with 5 percent in 1991. More of the recent respondents also cited unemployment and pressure to pay bills than in the earlier poll.

Bright spots in the new survey included drops in legal problems, incidents of infertility, and not having a car for a month or longer, the school found.


New Treatment Sanctioned for Bone Marrow Disorder

The Celgene Corp. drug Revlimid (lenalidomide) has been approved by the U.S. Food and Drug Administration to treat a certain form of Myelodysplastic Syndrome (MDS), a bone marrow abnormality.

MDS is a collection of disorders in which the bone marrow doesn't function properly and the body doesn't make enough normal blood cells. Patients often need blood and platelet transfusions and antibiotics to treat infections, the FDA said.

In clinical trials, most MDS patients with deletion 5q cytogenic abnormality didn't require as many transfusions three months after starting treatment with the drug, the agency said.

Some 7,000 to 12,000 cases of MDS are diagnosed each year in the United States. People over age 60 are most susceptible to the disease, whose symptoms include weakness, fatigue, infections, easy bruising, bleeding and fever.

Revlimid is similar to thalidomide, a drug proven to cause severe birth defects. Celgene is still conducting studies to determine if pregnant Revlimid users are subject to similar risks, the agency said. Until the results are known, the FDA said, the company is marketing the drug under a program designed to prevent fetal exposure.


Defibrillator Maker Gets FDA Warning

Guidant, the maker of implantable heart defibrillators and pacemakers, said Tuesday that it had received a warning letter from the U.S. Food and Drug Administration about unresolved issues that arose from an inspection of the company's operations in St. Paul, Minn., according to a company statement.

The letter from the FDA appears to indicate that Guidant has not been able to satisfactorily address the 15 observations the agency cited after a Sept. 1 inspection of the company's operations, The New York Times reported. The FDA's citations were first disclosed on Sept. 22 and the company had said then that it had answered the concerns.

Since June, Guidant has recalled or issued warnings for about 88,000 heart defibrillators and almost 200,000 pacemakers because of reported malfunctions. The company is under investigation by federal and state officials and faces dozens of lawsuits over its recalls, according to the Associated Press.

The latest FDA letter, which Guidant said it received on Dec. 23, says the agency will be demanding further action on its observations and would not grant requests for exportation certificates to foreign governments until those actions have been completed.

News of the letter comes on the heels of a New York Times report that said Guidant officials were aware that its defibrillators had deficiencies that could be "life threatening."

The newspaper, which has been tracking the problems with the defibrillator since the company recalled the model known as the Prizm 2 DR in June, reports that internal documents written in 2002 indicated that some patients might die because of short circuits. But the company never publicized the possible defect because its experts decided that the overall failure rate was acceptable.

The documents became public when they were filed last week in a Texas personal injury lawsuit. Lawsuits have also been filed in Pennsylvania and New York.


China to Produce 1 Billion Doses of Avian Flu Vaccine

China plans to produce 1 billion doses of a newly developed live vaccine and vaccinate all 14.2 billion farm poultry in the country to prevent fresh outbreaks of avian influenza and diminish the risk of a potential pandemic.

China approved the production and storage of the recombinant bivalent vaccine on Dec. 23, according to the Beijing-based Ministry of Agriculture's Web site. The vaccine can be applied by injection, through nasal sprays, eye drops and mixed in drinking water, Bloomberg news reported.

The development of the vaccine took four years for scientists at the Harbin Veterinary Research Institute of the Chinese Academy of Agricultural Sciences, the China Daily reported on its Web site, citing Chief Veterinary Officer Jia Youling.

Avian fluhas infected at least 141 people in Asia since 2003, killing at least 73 of them, the World Health Organization said on its Web site.

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