Rummy's bird-flu bonanza protected from liability (20/11/2005)

1.FDA to Examine Deaths of 12 Pediatric Tamiflu Patients in Japan
2.Protection for Vaccine Makers Debated

We recently noted how Bush and Blair's ultra-precautionary purchases of vaccines and antivirals happened to suit the financial interests of their own cronies. (see Rummy's bird flu bonanza & Blair backer's smallpox bonanza)

The president is seeking US$7.1 billion in emergency funding to prepare for the not-imminent not-pandemic danger of bird-flu, including $1 billion for the anti-viral Tamiflu, developed and patented by Gilead Sciences Inc. (part of Roche) when chaired by Donald Rumsfeld, who still holds a Gilead stake valued at between $5 million and $25 million, according to his federal financial disclosures.

The president is also writing protections for such companies into the bill that some say they would make it extremely difficult for those harmed by such a medicine to get any financial compensation (item 2). Given the reports coming out of Japan of possible deaths caused by Tamiflu, this could be extremely useful. (item 1)

Donald Rumsfeld has also done well out of the war on terror. As a precautionary measure against a smallpox attack, Rumsfeld ordered members of the armed forces to be inoculated against smallpox with a package that included injection with the drug Vistide - another product of Gilead Sciences.

In the UK the Ministry of Defence contract for the Blair government's precautionary purchase of large quantities of smallpox vaccine went to Powderject - the biotech company of Blair crony and financial supporter, Paul Drayson, who was also made a Lord and given a job in Blair's government aftyer donating a million pounds to Blair's party.

Perhaps Blair will also be introducing legal protections for vaccine manufacturers, following BBC revelations that Drayson's company, "sold faulty TB vaccines and kept quiet about it for 21 months, risking the health of thousands of people".

1.FDA to Examine Deaths of 12 Pediatric Tamiflu Patients in Japan
By ANDREW BRIDGES Associated Press Writer
The Associated Press, nOV 18 2005

WASHINGTON Nov 18, 2005 — The federal government is looking into the deaths of 12 Japanese children who took Tamiflu, but officials cautioned they have no evidence that suggests the anti-flu drug is to blame.

"Clearly, any time you get a report of a death or a serious occurrence, you want to look into it," said Dr. Murray Lumpkin, deputy commissioner of the U.S. Food and Drug Administration.

The reports are being discussed as part of the annual pediatric safety review of Tamiflu and seven other drugs. The Japanese deaths were detailed in papers released before Friday's meeting. There are no reports of deaths in the United States or Europe associated with Tamiflu.

The FDA sought and received more information from the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, and from Japanese health authorities. It has not issued any warnings or initiated any other action, spokeswoman Susan Bro said.

"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death," Lumpkin said.

An update by FDA staff also includes reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.

Roche said several studies in the United States and Canada had shown that the incidence of death in influenza patients who took Tamiflu was far lower than in those who did not.

The company also has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.

Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, Lumpkin said.

"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" he said.

The popularity of Tamiflu in Japan may explain in part the number of reports from that country: Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan, according to Roche.

2.Protection for Vaccine Makers Debated
Legislation would require proof of willful misconduct
The Associated Press, 16 November 2005

Washington - People injured by a vaccine against bird flu or anthrax would have to prove willful misconduct to bring a claim for damages against drug manufacturers or distributors, according to legislation being drafted behind the scenes by Republicans.

A 10-page draft of the legislation obtained by The Associated Press says it would be up to the Health and Human Services secretary to declare that such misconduct occurred. If that declaration is made, the case must be heard in federal court.

The measure, which would be included in a spending bill, would bar any punitive damages and limit awards for physical and emotional pain and suffering and other noneconomic damages to a maximum of $250,000.

The draft legislation was provided to the AP separately by two parties opposed to its provisions, who did not want to be identified.

An aide to Sen. Bill Frist, R-Tennessee, confirmed the majority leader was looking to add the liability protections to a spending bill.

Amy Call said the legislation is important because "it would be a pity to appropriate $7.1 billion to purchase vaccines and antivirals but have no capacity to produce them."

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