6 Men Hospitalized in Clinical Drug Trial
Two men are in critical condition and another four men are in serious but stable condition in a London hospital after they all suffered serious side effects while taking part in a clinical trial of an experimental drug.
The men were taking part in a clinical trial, conducted by Massachusetts-based Parexel International Corp., involving a monoclonal antibody called TGN 1412, which is being developed to treat conditions including leukemia and rheumatoid arthritis. The United Kingdom's Medicine and Healthcare Products Regulatory Agency halted trials of the drug and has launched an investigation, Bloomberg news reported.
All the men were admitted to North West London Hospital, which refused to reveal their identities.
But Ganesh Suntharalingam, clinical director of intensive care at the hospital, said, "The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body."
News reports said the six victims were among eight volunteers involved in the trial. The other two men in the group had been given a placebo and were unharmed.
TGN 1412 is being developed by TeGenero AG of Germany. Clinical trials of the drug had started only in England ,but TeGenero had received approval to test the drug in Germany, Bloomberg news reported.
In an e-mailed statement, Herman Scholtz, head of clinical pharmacology at Parexel, said: "Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."
Paraxel's clinical trial site in London specializes in testing the effects of drugs given to humans for the first time.
Sweden Confirms First Case of Bird Flu
Sweden has confirmed its first cases of H5N1 bird flu in two dead wild ducks and Denmark is testing a wild bird to see if it's the first case of H5N1 in that country, BBC News reported.
The dead ducks were found at the end of February in Oskarshamm, on Sweden's southeastern coast. Since then, an H5 bird flu virus subtype has been found in other wild birds. Tests are being conducted to determine whether those birds also had the H5N1 virus. So far, there are no reports of bird flu in domestic fowl in Sweden. The H5N1 virus has already been found in birds in a number of European countries. It has also been found in cats in Austria and Germany.
Along with Europe, the virus is currently present in Asia, Africa, and the Middle East. So far, more than 100 people have been killed by H5N1, which can be caught through direct contact with infected birds.
While it's believed that the virus has not yet been passed from human to human, experts fear H5N1 will mutate into a form that can be transmitted between people. This could trigger a flu pandemic that could kill millions, BBC News reported.
Bush Acknowledges Problems With Medicare Drug Plan
President George W. Bush acknowledged on Tuesday that the new Medicare prescription drug program has been plagued by problems in the early stages.
The admission, made in a speech in Canandaigua, N.Y., appeared to be an attempt to ease the barrage of complaints from retirees and pharmacists. Bush's speech about the Medicare drug program echoed previous speeches in which he conceded mistakes were made in the Hurricane Katrina response and the Iraq reconstruction, The New York Times reported.
In Tuesday's address, Bush said he had anticipated that the new drug program would have a difficult start.
"Any time Washington passes a new law, sometimes the transition period can be interesting," Bush said.
He also noted that several programs were available to explain Medicare options to beneficiaries, the Times reported.
Ambien Linked to Sleepwalking
Ambien, the leading prescription sleep medication in the United States, may be linked to incidents of sleepwalking and cases of people doing other strange and potentially dangerous things while they're asleep, including eating, talking on the phone, shoplifting, and driving, the Washington Post reported.
When they wake up, people have no memory of doing these activities.
There are a growing , though still inconclusive, number of reports that associate Ambien with such incidents, sleep experts and researchers say. A number of cases have been included in articles published in medical journals.
Patient and doctor reports to the U.S. Food and Drug Administration indicate that Ambien is associated with more sleepwalking incidents than all other sleep aids combined, the Post reported.
Mayo Clinic Sleep Disorders Center researcher Timothy Morgenthaler said he's seen many cases of people sleepwalking and sleep-eating after taking Ambien.
"I feel pretty comfortable that this is a real phenomenon," he told the Post.
Ambien is made by French company Sanofi-Aventis, which issued a statement saying that sleepwalking and related incidents are a known but rare side effect that's fully disclosed on the drug's labeling.
BiDil Benefits All Black Heart Failure Patients: Study
Both female and male black heart failure patients benefited from taking the drug BiDil in addition to standard heart failure therapy, according to a study presented Tuesday at the American College of Cardiology meeting in Atlanta.
Findings from the African American Heart Failure Trial (A-HeFT) showed that both women (228) and men (290) treated with BiDil (isosorbide dinitrate/hydralazine hydrochloride) experienced improved clinical outcomes for heart failure.
While all-cause death appeared to be lower in women than in men treated with BiDil, there was no significant difference in the benefit of BiDil on survival between men and women, the study said.
Additional data from A-HeFT showed that BiDil efficacy in black patients was not limited by severity of LV Ejection Fraction.
"These two analyses are significant as data from A-HeFT continue to provide valuable insight into the treatment of heart failure in black patients," Dr. Michael L. Sabolinski, chief medical officer of NitroMed Inc., said in a prepared statement.
Food Fact:
Culture club.
When yogurt's live active cultures colonize your digestive system, they draw a line in the sand against disease. The cultures -- especially acidophilus and bifida - muscle out potentially threatening bacteria. Low-fat or fat-free yogurt has a lot of other things going for it: It's easy to digest, especially for those who are lactose-intolerant and have difficulty digesting milk and many cheeses; it's an excellent source of calcium, protein, riboflavin (a B vitamin), vitamin B-12 (which may be low in vegetarian diets) and vitamin A; and provides selenium, potassium and magnesium.
Fitness Tip of the day:
Make exercise fun.
Revving up your workout routine can be as easy as making a list. When beginning a new exercise program, jot down your favorite everyday activities, and incorporate them into your fitness plan. If you enjoy walking with your dog, schedule longer walks along with more traditional forms of exercise such as weight training, flexibility training and cardiovascular programming.
FAQ of the day:
Can certain foods prevent cancer?
No one can say with absolute certainty how powerful is diet in preventing cancer. But at least a third (and possibly more) of all cancers have been linked to diet. People who eat the most fruits and vegetables have been shown to have about half the risk of developing cancer as people who rarely eat them. Your genes and other lifestyle factors, such as smoking, have a strong say in your susceptibility to cancer. But it's likely that improving the typical American diet would make a big dent in new cases of cancer, the nation's second biggest killer after heart disease.
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