GMW: Rummy's bird-flu bonanza protected from liability

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GMW: Rummy's bird-flu bonanza protected from liability

" GM WATCH " <info

Sun, 20 Nov 2005 14:31:22 GMT

 

 

 

GM WATCH daily

http://www.gmwatch.org

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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)

http://www.gmwatch.org/archive2.asp?arcid=5913

 

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.

http://www.gmwatch.org/archive2.asp?arcid=5913

 

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 " .

http://news.bbc.co.uk/2/hi/business/4446978.stm

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1.FDA to Examine Deaths of 12 Pediatric Tamiflu Patients in Japan

By ANDREW BRIDGES Associated Press Writer

The Associated Press, nOV 18 2005

http://abcnews.go.com/Health/wireStory?id=1325014

 

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.

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2.Protection for Vaccine Makers Debated

The Associated Press, 16 November 2005

http://www.truthout.org/issues_05/111705HA.shtml

 

Legislation would require proof of willful misconduct.

 

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. "

 

She said Frist is seeking clearly defined standards for an industry

that is already heavily regulated.

 

" We would only provide liability protection in a serious situation

and for a set period of time and for a specific purpose, " Call said.

" The protection would only go into effect if the secretary makes a

declaration that we are grave danger and the public is advised to take

the

product. "

 

President Bush's plan for dealing with a flu pandemic called on

Congress to give drug manufacturers sweeping immunity against lawsuits.

" In the past three decades, the number of vaccine manufacturers in

America has plummeted, as the industry has been flooded with

lawsuits, " Bush

said last month. " Today, there is only one manufacturer in the United

States that can produce influenza vaccine. "

 

Lawmakers from both political parties also have cited a need to

grant the industry some protections. However, the protections

described in

the draft are quite broad, and some say they would make it extremely

difficult for those harmed by a medicine to get any financial

compensation.

 

" The Republican leadership in Congress is trying to do another

special favor for the drug companies by slipping a provision into a

massive

spending bill to absolve the pharmaceutical industry of any

responsibility to patients injured by dangerous drugs or vaccines,

with no

compensation for those who are harmed, " Sen. Edward M. Kennedy,

D-Massachusetts, said in a statement.

 

He called for an open debate on the issue.

 

Sen. Mike Enzi, R-Wyoming, chairman of the Senate's health

committee, favors liability protections for drug manufacturers, but

not as part

of an appropriations bill, according to spokesman Craig Orfield.

 

" He does not want to address biodefense in a piecemeal fashion, "

Orfield said.

 

Trial lawyers said they oppose having to prove " willful misconduct "

to get financial compensation from an injury.

 

" Basically, as an average person, I would have to prove some

scientist at Merck or some CEO somewhere had made a determination to hurt

me, " said Chris Mather, a spokeswoman for the Association of Trial

Lawyers

for America.

 

Willful misconduct, according to the draft legislation, would occur

if manufacturers or distributors of a particular product knew that it

presented " a significant or unreasonable risk to human health " and there

was a " conscious failure to act " to avoid that risk.

 

If the HHS secretary rules against the petition, then those

claiming to be harmed could seek judicial review from the US Court of

Appeals.

 

Rep. Dave Weldon, R-Florida, a doctor who said he is involved

peripherally in the talks, said he doesn't want protections so broad that

people might be unwilling to take medicine in the event of a flu

pandemic.

 

" The way it's being discussed is lacking, " Weldon said.

 

Meanwhile, House GOP leaders have delayed until December any action

on President Bush's $7.1 billion request to prepare for a potential

bird flu pandemic. The development came as negotiators on a huge spending

bill covering health care and education programs met Monday night.

 

The House rejected an almost $8 billion Senate plan to fight the

flu, saying it will revisit the issue next month as it also turns to

Bush's request to direct emergency funds already enacted for victims of

Hurricane Katrina to new purposes such as rebuilding highways, levees and

federal facilities damaged by the storm.

 

 

 

 

 

 

 

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