Tamiflu Child Deaths Raise Bird Flu Drug Fears

JAMES BONE / The Times (UK) 19nov2005

New York — THE death in Japan of 12 children who were taking Tamiflu has prompted an American government investigation of the only drug thought to be effective in treating bird flu.

The US Food and Drug Administration (FDA) said it was concerned that 32 psychiatric events, such as hallucinations and abnormal behaviour, had also been reported in children who took Tamiflu, all but one of them in Japan.

“Any time you get a report of a death or a serious occurrence, you want to look into it,” Dr Murray Lumpkin, the deputy commissioner of the FDA, said.

The deaths of 12 children, aged 1 to 9, included one suicide, four cases of sudden death and four cases of cardiac arrest, as well as single cases of pneumonia, asphyxiation and acute pancreatitis. They all took place since 2000.

The FDA said: “The level of detail in these reports was highly variable, and determining the contribution of Tamiflu to the deaths was difficult.”

However, the FDA’s advisory panel of independent scientists later said that no harmful effect of Tamiflu had so far been discovered. “If we ever have a pandemic of avian flu, which is a debatable point, people want to know that they have a drug that will not cause more (harm) than the flu itself,” Dr Robert Nelson, chairman of the FDA’s Paediatric Advisory Committee, said. “There is no evidence that it will.”

Millions of doses of Tamiflu are being stockpiled around the world as bird flu spreads from Asia, where it has killed at least 64 people. Experts fear a worldwide pandemic if the virus mutates into a form that can be passed easily between people. Japan, where Tamiflu is routinely used during the winter flu season, is the only country with extensive experience of the drug. Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan.

The Japanese Health Ministry issued a warning last week that Tamiflu might induce strange behaviour after the deaths of two teenage boys shortly after taking the drug.

Roche, the Swiss manufacturer of the drug, said that it had “carefully reviewed these events and has concluded that a causal link cannot be established”. Roche, which plans to increase production of Tamiflu tenfold by the end of next year, said that several studies had shown that the incidence of death in influenza patients who took Tamiflu was far lower than in those who did not.

source: http://www.timesonline.co.uk/article/0,,11069-1878556,00.html 20nov2005

Vaccination is Not Solution

VALERIE ELLIOT / The Times (UK) 17nov2005

THE Government has the legal power to order the vaccination of all poultry to control disease.

There are problems with the vaccines available, however, and the task would be a huge one.

Each bird would need to be injected individually and some of them may need two doses. In addition it can take three weeks for the birds to develop immunity.

Vaccination does not prevent the birds from becoming infected and passing the virus to other birds. A vaccinated bird may also suppress clinical signs of the disease, making it more difficult to detect and eradicate it.

Senior vets and officials at the Department for Environment, Food and Rural Affairs are nevertheless looking at other countries where vaccination has been used. In many parts of the world where birds have been vaccinated, the disease has persisted.

There is a possibility that vaccination may be used in this country to protect collections of rare breeds and endangered species in zoos and bird parks.

However, at present there is no single avian flu vaccine with a marketing authorisation in Britain and, in any event, emergency use of such a vaccine needs the consent of the European Union.

The main defences are therefore to create fortress farms with strict biosecurity, the feeding and watering of birds indoors to deter wild birds, extra veterinary surveillance on farms and the slaughter of all infected birds.

source: http://www.timesonline.co.uk/article/0,,25149-1875636,00.html 20nov2005

US FDA: No Evidence Tamiflu Caused Japan Deaths

LISA RICHWINE / Reuters 18nov2005

GAITHERSBURG, Md., Nov 18 — U.S. regulators do not have enough evidence to say Roche AG's anti-flu drug Tamiflu caused deaths or psychiatric problems in children in Japan, Food and Drug Administration officials said on Friday.

The FDA has been studying reports of 12 deaths and 32 cases of psychiatric problems in children who had taken Roche's drug, which is in high demand as a defense against a possible avian flu pandemic in people.

All but one of the psychiatric events, which included hallucinations and abnormal behavior, also were reported in Japan.

FDA officials are seeking input about the reports from a panel of outside experts meeting Friday.

Linda Lewis, an FDA medical officer, said in prepared remarks there was "insufficient evidence to establish that deaths and neuropsychiatric events represent a safety signal associated with Tamiflu."

The agency will ask the committee if it agrees the FDA should continue monitoring Tamiflu's safety in children and report back to the panel within two years.

The FDA has no current plan to add warnings about the deaths or psychiatric problems to the Tamiflu label, Lewis said. But officials will ask the panel if new information should be added about serious skin reactions, which are already mentioned as a possible side effect.

Interest in Tamiflu has risen as experts around the world warned of a possible H5N1 bird flu pandemic in people. Several countries are stockpiling Tamiflu, which may lessen symptoms.

Tamiflu is used widely in Japan to treat the annual influenza. From 2001 to 2005, there were 24.5 million Tamiflu prescriptions in Japan, and 6.5 million in the United States.

There is some evidence Japan was more vigilant about reporting problems in Tamiflu patients, FDA officials said.

Roche said information from databases of Tamiflu use and other research showed there was no increase in deaths and psychiatric problems in Tamiflu patients compared with influenza patients in general.

"The benefit/risk ratio for Tamiflu is unchanged and remains positive," said Dr. Joseph Hoffman, Roche vice president for pharmaceutical development.

Roche shares gained 2 percent in Swiss trading.

Shares of Gilead Sciences Inc., which invented Tamiflu and receives royalties on its sales, were up 9 cents to $54.84 in late morning trading on Nasdaq.

source: http://today.reuters.com/investing/financeArticle.aspx?type=governmentFilingsNews&storyID=URI:urn:newsml:reuters.com:20051118:MTFH50167_2005-11-18_17-20-18_N18535471:1 20nov2005

Is Tamiflu Safe For Children?

KATE WALKER / UPI 19nov2005

WASHINGTON, DC — The U.S. Food and Drug Administration is investigating the safety of administering Tamiflu to children following reports of deaths of 12 children who took the drug in the past 13 months.

The 12 deaths included one suicide, four cases of sudden death and four heart attacks. Other deaths involved asphyxiation, pneumonia and acute pancreatitis.

There have also been 32 cases of psychiatric abnormalities, including delusions, hallucinations and delirium, reported in children who had taken Tamiflu. Thirty-one of the cases involving psychiatric episodes occurred in Japan.

Two of the psychiatric cases under FDA review involved teenagers who jumped from second-floor windows after taking two doses of the drug.

\'In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail. The level of detail in these reports was highly variable and determining the contribution of Tamiflu to the deaths was difficult,\' the FDA summary said.

Meanwhile:

--China Friday reported two further outbreaks of avian influenza, bringing the monthly total to 15.

The outbreaks, in Shanxi and Xinjiang provinces, were hundreds of miles apart.

--Lingtan, the village where China`s fist human bird-flu victim died last week, has been locked down by government authorities, with only local residents permitted to enter or leave.

--Beijing has designated two hospitals in the city to deal with emergency cases of bird flu, Xinhua news agency reported Friday. The \'hospitals are to arrange sufficient and competent medical staff and will form a special team to deal with any outbreak of the disease,\' according to Xinhua.

All of the capital`s hospitals have been asked to improve training in prevention and control of avian influenza in humans.

--Sinovac Biotech, a Beijing-based vaccine producer, has announced plans to start mass-producing an avian influenza vaccine. The company was the first to produce a SARS vaccine.

\'We have applied for human clinical trials for the vaccine with the Chinese State Food and Drug Administration and the vaccine can be put into production once the clinical trials complete,\' Yin Weidong, Sinovac Biotech`s general manager, told CRI Online.

\'We get the virus samples from the lab of the influenza center under the World Health Organization and the research is going on well. If the bird flu virus mutates, we can develop new vaccines in four months.\'

--Two further reports of epidemics in northern provinces mean that more 25 percent of Vietnamese provinces and cities have now suffered avian-flu outbreaks.

In the last month, 17 of the country`s provinces and cities have been affected by avian influenza, from a total of 64.

source: http://news.monstersandcritics.com/health/printer_1063165.php 20nov2005