Health Highlights: June 9, 2005
Viagra Lawsuit Alleges Blindness Link U.S. Falling Behind on Infant Mortality Goals U.S. Drug Safety System 'Broken Down': FDA Official Endovascular Repair Not a Long-Term Lifesaver: Study Pulmonary Embolism May Have Killed Jesus, Researcher Theorizes Patients Lose Lawsuit for Discontinued Drug
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Viagra Lawsuit Alleges Blindness Link
A Montgomery County, Texas, man has filed one of the first lawsuits against the maker of Viagra, alleging that the anti-impotence drug may have contributed to his blindness, the Houston Chronicle reported.
The suit was filed by James Thompson, alleging that Pfizer Inc. failed to warn him of a possible link with a form of blindness abbreviated NAION (non-arteritic anterior ischemic optic neuropathy). The condition results from a sudden drop in blood pressure, which cuts the flow of blood to the optic nerve, the newspaper said.
In a statement on its Web site, Pfizer said clinical trials involving 13,000 men did not uncover the possibility of the blinding condition. "There is no evidence showing that [NAION] occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra," the statement said.
Last month, the U.S. Food and Drug Administration said it was investigating 43 reports of varying degrees of vision loss -- including blindness -- among 38 users of Viagra, as well as a handful of users of other anti-impotence drugs.
An estimated 23 million American men have taken these anti-impotence drugs, HealthDay reported at the time.
U.S. Falling Behind on Infant Mortality Goals
Despite recent declines in infant mortality in the United States, the nation will be hard pressed to reach its 2010 goal of reducing the rate to 4.5 infant deaths per 1,000 live births, the Centers for Disease Control and Prevention said Thursday in its Morbidity and Mortality Weekly Report.
The rate would have to drop 36 percent within the next five years from the 2002 mortality rate of 7.0 deaths per 1,000 live births, the agency said. Even more dramatic declines will be needed among non-Hispanic blacks and among Native Americans to achieve the target and reduce the disparity between ethnic and racial groups, the CDC added. The goals were set in the year 2000.
A total of 225,534 infant deaths were reported in the United States from 1995 to 2002, the most recent year for which statistics are available. Non-Hispanic whites accounted for 110,982 of the deaths, followed by non-Hispanic blacks at 65,339, and Hispanics at 35,447.
The CDC's state-by-state breakdown through 2002 showed that as of three years ago, no state had achieved the 4.5 percent target rate. New Hampshire had the lowest rate at the time at 4.9 percent, followed by Massachusetts (5.0), Maine (5.3), and Utah (5.4). The District of Columbia had the highest rate at 13.5 percent, followed by Mississippi (10.4), Alabama (9.7), and Louisiana (9.5).
U.S. Drug Safety System 'Broken Down': FDA Official
The U.S. drug safety system is "pretty much broken down" and there's room for "a lot of improvement" in how the government finds dangers in drugs already on the market, a key Food and Drug Administration official said Wednesday.
"The keystone of the current system is the prescriber, and that person is the one who decides if the benefits of a drug outweigh the risks for that patient," Dr. Janet Woodstock, deputy commissioner of operations at the FDA, told a committee of experts at the Institute of Medicine.
"This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient," she added.
The Institute of Medicine committee has been asked by the FDA to suggest improvements in the nation's drug safety system in the wake of a series of problems, including the market withdrawal of two popular painkillers, The New York Times reported.
The institute isn't expected to release its recommendations until next year. Until then, an FDA-appointed board will oversee drug safety.
Endovascular Repair Not a Long-Term Lifesaver: Study
Endovascular repair, a promising technique to repair dangerous abdominal aneurysms, does save more lives than open surgery initially, but not over the long term, according to a Dutch study in Thursday's New England Journal of Medicine.
In endovascular repair, surgeons thread a cloth patch through an artery from the groin in order to reach the site of the aneurysm (bulge) on the abdominal aorta. The cloth patch is held in place by a spring-like device called a stent, the Associated Press reported.
This method reduced the patients' chances of dying within a month by about 75 percent, compared with open surgery, the Dutch team reported last fall. In open surgery, the abdomen is cut open and a patch is sewn into the aneurysm site.
In this latest study, the Dutch researchers said that after two years, about 90 percent of 350 patients who received either endovascular repair or open surgery were still alive. The most frail patients were most likely to die soon after having open surgery, compared with endovascular repair, the AP reported.
However, very sick patients who lived through endovascular repair were more likely to die within the following two years than those who had open surgery, the study said.
Pulmonary Embolism May Have Killed Jesus, Researcher Theorizes
An Israeli researcher claims that Jesus may have died from a pulmonary embolism, which is caused when a blood clot, usually from the legs, travels to the lungs, the Associated Press reported.
Dr. Benjamin Brenner of the Rambam Medical Center in Haifa, said he's promoting this theory in order to increase awareness about pulmonary embolism. The potentially-fatal disorder is often associated with long-distance air travel.
"It is known that the common cause of death in the setting of multiple trauma, immobilization and dehydration is pulmonary embolism," Brenner wrote in the Journal of Thrombosis and Haemostasis. "That fits well with Jesus' condition and actually was in all likelihood the major cause of death of crucified victims."
He said that most of the public and many doctors aren't aware of pulmonary embolism. About 80 percent of pulmonary embolisms are diagnosed only in autopsies, Brenner told the AP.
Patients Lose Lawsuit for Discontinued Drug
Two people with Parkinson's disease have lost a lawsuit to force a drug company to continue supplying them with a discontinued drug that they received during a clinical trial.
A U.S. federal judge ruled Monday that Amgen was under no contractual obligation to continue supplying the drug -- called glial cell line-derived neurotrophic factor (GDNF) -- to the patients, The New York Times reported.
The patients accused Amgen of using them as "mere guinea pigs." They charged that Amgen had a legal and moral obligation to continue the drug treatment, which the patients said had eased their symptoms of Parkinson's disease.
In his ruling, Judge P. Kevin Castel of United States District Court in Manhattan said that the informed consent forms signed by the patients before they took part in the clinical trial explicitly acknowledged the company's right to terminate treatment, the Times reported.