Drug Makers Lag on Promised Studies of Products: FDA
Drug makers have failed to begin more than 70 percent of promised studies on products already approved for market, according to U.S. government numbers released Thursday, and a watchdog group is sick of it.
The U.S. Food and Drug Administration report shows that 899 -- or 71 percent -- of the 1,259 post-market studies committed to by drug makers had not been started as of Sept. 30, 2006. That's a 5 percent increase over last year, when the agency reported 65 percent of 1,231 promised studies were still pending, Bloomberg News reported Thursday. The report also found that only 185 -- or 15 percent --of studies were ongoing, 31 were delayed, and 144 were submitted.
"How can the FDA claim it is committed to improving drug safety when it can't even get drug makers to do the studies they promise?" said Bill Vaughan, senior policy analyst with Consumers Union. "Should consumers really feel safe when two out of three studies aren't being done, and the FDA doesn't even have the authority to get them done?"
While the FDA has no authority under law to require those studies be performed, it approves some drugs with outstanding safety concerns on the promise that the maker will conduct post-market studies to determine if the medication causes any side effects.
'Neglected' Diseases Need More World Focus: WHO Chief
The international community must pay more attention to "neglected" diseases that affect a billion people in the developing world and cause more suffering and death than high-profile health threats such as bird flu, says Margaret Chan, head of the World Health Organization.
These diseases don't receive much attention because they don't pose a threat to international health and security, Chan told a health conference in Bangkok, Thailand, CBC News reported.
"They do not flare up in outbreaks with high mortality. They do not grab media headlines. They do not travel abroad or threaten international security," Chan said.
She also noted that these diseases affect populations with low literacy and little political voice, CBC News reported. Pharmaceutical companies have little financial incentive to develop drugs and vaccines for these diseases and poor health care systems hinder the delivery of available drugs, she added.
These "neglected" or "silent" diseases include:
Lymphatic filariasis -- a parasitic disease that causes swelling in limbs
Schistosomiasis (snail fever) -- a parasitic disease that leaves people too weak to work
Trypanosomiasis (sleeping sickness) -- a parasitic disease that overwhelms the immune system.
Case Studies Raise Concerns About Abuse of Alcohol-Based Hand Sanitizers
Concerns about the abuse of alcohol-based hand sanitizers are highlighted in case studies published in Thursday's New England Journal of Medicine. The alcohol in these products is not the same as the type found in drinks.
One letter to the journal describes the case of a 49-year-old U.S. prison inmate who became intoxicated by drinking alcohol-based hand sanitizer. The letter said the inmate was described as becoming "red-eyed, loony and combative," after he was seen to drink from a gallon container of Purell hand sanitizer, CBC News reported.
A second letter describes a 43-year-old alcoholic with mysterious chest pains who drank hand wash that had isopropyl alcohol from a dispenser in a U.S. hospital washroom.
The authors of the second letter noted that ingesting about 200 milliliters of isopropanol can prove fatal because it depresses the central nervous system and the heart, CBC News reported.
It may be a good idea to change the labels on alcohol-based hand sanitizers, the authors concluded.
Scientists Reverse Prion Disease Symptoms in Mice
U.K. researchers say they've found a way to reverse symptoms of prion diseases, such as the human form of mad cow disease (vCJD), in mice.
By halting production of proteins corrupted by such diseases, the Medical Research Council scientists were able to reverse memory and behavior problems in the mice, BBC News reported.
The study was published in the journal Neuron.
The results suggest that it may be possible to treat people with prion disease before the brain is permanently damaged, the researchers said. However, that would depend on having a test to detect vCJD (variant Creutzfeldt-Jakob disease) at the early stages, the study authors added.
"This is potentially very important work because it shows something which we didn't expect and which could be extremely significant," Roger Morris, a professor of molecular biology at King's College London, told BBC News. He was not involved in the study.
"It means that the prospect of being able to do something for people may be much better than we thought. We may be able to reverse the behavioral effects," of prion disease, Morris added.
Japan Confirms 4th Bird Flu Outbreak This Year
Japanese officials said Thursday they've confirmed the country's fourth outbreak of bird flu in poultry this year. Tests are still being conducted to determine if it's the deadly H5N1 virus or a less dangerous H5N2 virus.
In this latest outbreak, more than 80 chickens died at a poultry farm in the town of Shintomicho in Miyazaki prefecture on the southern island of Kyushu. In response, officials ordered the slaughter of 93,000 chickens, Agence France Presse reported.
In January, there were two cases of H5N1 in Miyazaki prefecture and another outbreak of bird flu in Okayama prefecture on the island of Honshu.
In related news, officials have been conducting door-to-door checks in the Indonesian capital of Jakarta to enforce a ban on domestic poultry. The ban is meant to help fight bird flu, which has killed six people in the country so far this year and 63 people since June 2005, AFP reported.
As of Thursday, more than 100,000 birds collected from the capital had been slaughtered, but it's estimated there are more than one million birds still in Jakarta, officials said.