Twin Pharma Give-A-Ways: Biodefense Vaccine /Drug Development Act–S. 1873_ $7 bill Bird Flu Plan
Wed, 2 Nov 2005
If the Administration were serious about preparing for an avian flu pandemic–or for ANY health disaster for that matter–the money would be spent on developing reliable infrastructures at the state and local level. What we witnessed in New Orleans was bedlam and health care workers abandoned without basic first-aid equipment.
Instead, the Administration is paying for vaccines that have no relevance to avian flu. The only beneficiaries of this $7 billion public give-a-way are the biotech andpharmaceutical industry. Furthermore, “Bush’s plan would also make drug or vaccine companies less vulnerable to lawsuits over safety or side effects.²
Indeed the public is utterly unaware about a radical bill, the “Biodefense and Pandemic Vaccine and Drug Development Act of 2005″(S. 1873), that has already passed the Senate HELP committee in one day–without so much as a public hearing! The bill, according to those who have read it, is “a drug company stockholder’s dream and a consumer’s worst nightmare.”
When the original Homeland Security Act was signed into law (2002) , someone ³mysteriously² inserted a clause giving Eli Lilly immunity from parents who were suing the company for its mercury-laced vaccines. See:
The proposed legislation‹S. 1873–will effectively strip Americans of the right to a trial by jury if harmed by an experimental or licensed drug or vaccine that the government forces them to take, whenever federal health officials declare a public health emergency.
This legislation would with one swipe, strip Americans of their inalienable right to voluntary, informed consent. If passed into law, this would spell the end of the American democratic process.
Contact: Vera Hassner Sharav
Bush requests $7.1 billion to stop bird flu
BAY AREA COMPANIES LIKELY TO BENEFIT
By Steve Johnson
President Bush proposed a $7.1 billion plan Tuesday to protect the nation against a potential bird-flu pandemic by ramping up funding for vaccines and anti-viral drugs that could boost several Bay Area companies. “It’s really an encouraging step,” said Dino Dina, chief executive of Dynavax Technologies of Berkeley, who hopes to get some of the money for a drug it is developing to increase the effectiveness of bird-flu vaccines.
More details on the government’s preparedness plan for a pandemic, or worldwide epidemic, are expected to be unveiled today. But Bush made it clear in announcing his proposal during a speech at the National Institutes of Health that he considered bird flu a matter of urgent concern. “If we wait for a pandemic to appear, it will be too late to prepare, and one day many lives could be needlessly lost because we failed to act today,” he said.
The virus has spread among birds, primarily in Asia but with more recent outbreaks in Eastern Europe. So far it has also killed 62 people, all in Asia, but experts fear the virus could mutate into a form that could spread among people and kill millions more.
On Tuesday, Canadian authorities reported finding it in wild birds in British Columbia, a day after nearly three dozen birds were found to have the virus in Quebec and Manitoba. But it’s unclear if the strain found in Canada is the one linked to human deaths.
Most of Bush’s plan, which requires Congressional approval, would involve stockpiling and developing drugs to counter bird flu.
Bush proposed allocating $1.519 billion to buy vaccines, to keep people from becoming infected, and $1.029 billion for anti-viral drugs, to minimize the illness once someone is exposed to the virus. Another $3.6 billion would be to develop new vaccines or other treatments, as well as a new method to make vaccines using cell cultures instead of the less reliable method of making it from chicken eggs.
The rest of the money would help governmental agencies monitor and prepare for a possible bird-flu outbreak. Bush’s plan would also make drug or vaccine companies less vulnerable to lawsuits over safety or side effects. Federal officials haven’t spelled out who would get the money. “Those are all issues that are in the process of being determined,” said White House spokesman Ken Lisaius.
Nonetheless, Chiron of Emeryville and Gilead Sciences of Foster City, which both have track records in this field, are likely candidates.
Despite contamination problems at two of Chiron’s winter flu-vaccine plants in Europe this past year, the government considers the firm a key player in the battle against bird-flu.
Chiron has developed vaccines for two of the bird-flu strains — including the most virulent H5N1 form — and just last week won a $62.5 million federal contract to begin manufacturing a bird-flu vaccine. Chiron and federal officials also announced last week that another Chiron product appears to significantly increase the effectiveness of bird-flu vaccines.
Gilead developed the anti-viral drug Tamiflu, which was singled out for mention in Bush’s announcement, along with Relenza, made by GlaxoSmithKline of England. Under a licensing deal, Tamiflu is manufactured by Roche and Gilead receives royalties, typically 10 percent. Assuming the $1.029 billion Bush has allocated for anti-viral drugs is split evenly among Tamiflu and Relenza, Gilead’s share would likely be about $50 million.
Other local companies could benefit, too.
After hearing about Bush’s plan, executives at Juvaris BioTherapeutics of Pleasanton immediately began discussing how to apply for some of the money for a bird-flu vaccine they are developing.“We intend to absolutely find that out and pursue it,” said Martin Cleary, chief executive at Juvaris.
It’s unclear which vaccines or anti-viral drugs may prove most effective against bird flu, if the virus mutates into a form that can be transmitted by humans. “You might see — for lack of a better word — money being thrown around for different therapies,” said Ren Benjamin, an analyst with Rodman and Renshaw. “There could be a number of winners.”
Not everyone is happy about Bush’s plan.
Vera Hassner Sharav, president of the non-profit Alliance for Human Research Protection in New York, contends fears about bird flu are exaggerated and considers Bush’s plan a waste of money. “What we’re having here is essentially a transfer of wealth from the taxpayer to the pharmaceutical industry,” she said.
But Cornelia Dekker, who directs a Stanford vaccine program and is on the federal government’s National Vaccine Advisory Committee, said there is cause for worry. Although it’s hard to know if the bird flu will develop into a pandemic, “there are worrisome signs,” she said. “This is something to take seriously.”
NVIC Press Release
Wednesday, October 19, 2005
CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES
Washington, D.C. – The National Vaccine Information Center (NVIC) is calling the “Biodefense and Pandemic Vaccine and Drug Development Act of 2005″(S. 1873), which passed out of the U.S. Senate HELP Committee one day after it was introduced “a drug company stockholder’s dream and a consumer’s worst nightmare.” The proposed legislation will strip Americans of the right to a trial by jury if harmed by an experimental or licensed drug or vaccine that they are forced by government to take, whenever federal health officials declare a public health emergency.
The legislation’s architect, Senator Richard Burr (R-NC), Chairman of the HELP Subcommittee on Bioterrorism and Public Health Preparedness, told the full HELP Committee yesterday that the legislation” creates a true partnership” between the federal government, the pharmaceutical industry and academia to walk the drug companies “through the Valley of Death” in bringing a new vaccine or drug to market. Burr said it will give the Department of Health and Human Services “additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines.” The Burr bill gives the Secretary of DHHS the sole authority to decide whether a manufacturer violated laws mandating drug safety and bans citizens from challenging his decision in the civil court system.
The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single point of authority within the government for the advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks such as the flu. BARDA will operate in secret, exempt from the Freedom of Information Act and the Federal Advisory Committee Act, insuring that no evidence of injuries or deaths caused by drugs and vaccines labeled as “countermeasures” will become public.
Nicknamed “Bioshield Two,” the legislation is being pushed rapidly through Congress without time for voters to make their voices heard by their elected representatives. Co-sponsored by Republican Senate Majority Leader Bill Frist (R-TN), Senate Health, Education, Labor and Pensions Committee Chairman Mike Enzi (R-WY), and Senate Budget Committee Chairman Judd Gregg (R-NH), the legislation will eliminate both regulatory and legal safeguards applied to vaccines as well as take away the right of children and adults harmed by vaccines and drugs to present their case in front of a jury in a civil court of law.
“It is a sad day for this nation when Congress is frightened and bullied into allowing one profit making industry to destroy the seventh Amendment to the Constitution guaranteeing citizens their day in court in front of a jury of their peers,” said Barbara Loe Fisher, president of NVIC. “This proposed legislation, like the power and money grab by federal health officials and industry in the Homeland Security Act of 2002 and the Project Bioshield Act of 2004, is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur. It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take, that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine.”
The federal Food and Drug Administration (FDA) is legally responsible for regulating the pharmaceutical industry and ensuring that drugs and vaccines released to the public are safe and effective. Drug companies marketing painkillers, like Vioxx, and anti-depressants, which have resulted in the deaths and injuries of thousands of children and adults, are being held accountable in civil court while the FDA has come under intense criticism for withholding information about the drugs’ dangers from the public. Since 1986, vaccine makers have been protected from most liability in civil court through the National Childhood Vaccine Injury Act in which Congress created a federal vaccine injury compensation program (VICP) that offers vaccine victims an alternative to the court system. Even though the the program has awarded nearly $2 billion to victims of mandated vaccines, two out of three plaintiffs are turned away.
“The drug companies and doctors got all the liability protection they needed in 1986 but they are greedy and want more,” said Fisher. “And the federal health agencies want more power to force citizens to use vaccines without having to worry about properly regulating them. If the Burr bill passes, all economic incentives to insure mandated vaccines are safe will be removed and the American people are facing a future where government can force them to take poorly regulated experimental drugs and vaccines labeled as “countermeasures” or go to jail. The only recourse for citizens will be to strike down mandatory vaccination laws so vaccines will be subject to the law of supply and demand in the marketplace. The health care consumer’s cry will be: No liability? No mandates.”
The National Vaccine Information Center (NVIC) was founded by parents of vaccine injured children in 1982 and co-founders worked with Congress on the National Childhood Vaccine Injury Act of 1986.
Niagara Falls Reporter
MOUNTAIN VIEWS: BIRD FLU SCAM TO COST US PLENTY
By John Hanchette
OLEAN — The current U.S. Congress has many qualities that are not endearing, but one of the worst is its addiction to hidden agendas. Case in point:
In the middle of last week, one short day after the bill had been introduced, the powerful Senate Health, Education, Labor and Pensions Committee — by a quick, simple voice vote of the full panel — passed something called the “Biodefense and Pandemic Vaccine and Drug Development Act of 2005.”
It will probably hit the Senate floor this week for a full vote of that august chamber (and may have already done so by the time you read this). A similar companion bill is expected to be introduced in the House of Representatives before week’s end. The lobbying lubrication needed in that conservative chamber to ram it through passage will be even less than in the Senate.
The Senate proposal (S.1873) — authored and filed by North Carolina Republican senator Richard Burr, an obedient favorite of the current Bush administration — sounds innocent and altruistic enough, right?
It would establish an efficient-sounding Biomedical Advanced Research and Development Agency (BARDA) to speed up and “provide incentives and protections” for the “domestic manufacture of medical countermeasures” — vaccines and drugs — that would help stop pandemic or epidemic sickness within the United States. Burr said in introducing the bill that it will simply give the Cabinet-level Department of Health and Human Services (HHS) the “additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines.”
So, who could be against such a lofty goal? Well, I could, for one. This bill is a slavering wolverine masquerading as a furry little lab rat. First of all, whenever you — as consumers, taxpayers and citizens — hear any federal government source saying it wants “to partner with the private sector,” you should grab your wallet with both hands and hold on tight. In this case, you should also take your children into your arms. I’m not the only one who’s noticed the danger in this proposal.
Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC) — a private, non-governmental advocacy group pushing for safer vaccines — calls the Senate bill “a drug company stockholder’s dream and a consumer’s worst nightmare.” It is, simply put, a legislative genuflection to Big Pharma — the steamroller-powerful drug-making sector of the economy. The pharmaceutical mega-firms contribute millions to the coffers of congressional members, but if this is signed into law, they potentially could save billions.
That’s because this proposed legislation will strip Americans of the right to a trial by jury if they are harmed by either an experimental or licensed drug or vaccine they are forced by the government to take whenever federal health officials declare a public health emergency.
This bill gives the HHS secretary the sole authority to decide if a drug manufacturer violated laws that mandate drug safety, and it bans any citizen from challenging the HHS head’s decision in the civil court system. Big Pharma has been pushing for protection like this for several years. In this millennium, the angst and sense of loss following 9/11 was manipulated to produce similar legislative efforts designed to protect drug and vaccine makers even if they manufactured products that were not properly tested, nor clinically proven safe.
“This proposed legislation,” said NVIC’s Fisher, “like the power and money grab by federal health officials and industry in the Homeland Security Act of 2002 and the Project Bioshield Act of 2004, is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines.” Further, Fisher points out, the government, under this bill, “could force all citizens to use these drugs and vaccines while absolving everyone connected from any responsibility for injuries and deaths which occur” in their wake.
Sen. Burr is himself the chairman of the Senate Subcommittee on Bioterrorism and Public Health Preparedness. In his bill, BARDA — the new R and D agency mentioned above — would be established as the single point of authority in the federal system for the advanced research and development of vaccines and drugs in response to bioterrorism and outbreaks of natural disease.
And BARDA would operate in secret.
The agency would be exempt from the Freedom of Information Act and from the Federal Advisory Committee Act, which requires public public transparency — making it almost certain that no evidence of injuries or deaths caused by drugs and vaccines labeled as “countermeasures” to bioterrorism or new disease epidemics would ever become public. The bill would not only provide Big Pharma impenetrable cover, it would exempt lots of federal cost oversight requirements, and would forbid government purchases of generic versions of such new drugs or vaccines, a current practice that saves taxpayers millions of dollars.
The Burr bill means, notes vaccine safety advocate Fisher, “that if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take, that citizen will be banned from exercising the constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine.”
Burr himself has acknowledged that “liability exposure” is one of the factors that has left drug firms “reluctant to invest” in biodefense and influenza countermeasures. The timing of the new attempt at congressional protection for Big Pharma — the Burr bill — is exquisite. The wording “natural outbreaks” of disease and “pandemics” mentioned by Sen. Burr in his call for support of the bill are designed to make citizens and fellow senators alike think of one thing — avian flu. This new biological “threat” is increasingly on the minds of Americans and is reaching near-panic level in terms of public perception.
David Daigle, a spokesman for the federal Centers for Disease Control and Prevention, said the CDC has been experiencing an incredible average of 447,000 hits a day on its bird flu information Web site. He pegged the Internet traffic level “insane.” Americans are avalanching health officials, newspapers, TV stations, their doctors and other public information sources with anxious questions about keeping bird-feeders in their back yards, whether they can eat turkey this Thanksgiving, and whether they should report sightings of dead birds along the roadside. (You can, you can, you don’t have to.)Worried patients are asking their doctors for Tamiflu, designed to treat ordinary human flu — not bird flu.
And guess the number of Americans who have died of avian flu already? Zero.
How many human cases of the bird flu have been reported in the United States? Zero. That’s right, none.
The bird flu, which originated in South Korea more than two years ago, rarely spreads from birds to humans, and hasn’t even been shown to affect poultry yet in this country. Only 120 or so humans have ever come down with this rare viral strain of influenza — H5N1 — and all of them in Asia. Most of the 60 deaths so far — 43 — have occurred in Vietnam. Thailand has the next largest number of deaths, 13. The disease in birds is just now reaching eastern Europe through avian migration. Turkey, Romania, and European Russia have cataloged the dangerous strain. The virus might be an eventual threat to the flocks of poultry farmers here, but many scientists seem to think H5N1 influenza won’t sicken or kill humans on a mass basis unless its mutating properties change dramatically.
Can Senate Democrats stop the passage of Burr’s bill? Not bloody likely. Several Democrats in that chamber have criticized the Burr bill, but mostly from the perspective that it would do little to provide any response to an avian flu outbreak. “I hope that people don’t think this is going to solve the problem of the possible avian flu pandemic that is on our doorstep,” warned Sen. Tom Harkin, an Iowa Democrat.
This legislation is obviously fast-tracked. Senate Majority Leader Bill Frist, the Tennessee Republican, is a co-sponsor, as is Senate Budget Committee Chairman Judd Gregg, a Republican from New Hampshire. They obviously don’t care that if signed into law, this proposal would eliminate both legal and regulatory safeguards, applied to vaccines and drugs, that need strengthening, not weakening or elimination. They obviously don’t care if children or adults harmed by vaccines and drugs will have to forfeit their right to present a case in front of a jury in a civil court of law.
Don’t think this never happens. The Food and Drug Administration is legally responsible at present for regulating Big Pharma, and for ensuring that vaccines and drugs released to the public are safe and effective. Drug companies marketing pain-killer and anti-depressants that have injured thousands are being held accountable in civil courts all the time. And the FDA has come under intense criticism for keeping information from the American public about drug dangers.
For almost two decades, vaccine makers have already been protected from most liability in civil courts through the National Childhood Vaccine Injury Act of 1986 and a concurrent compensation program that offers victims an alternative to civil courts. That program has already awarded almost $2 billion to injured victims of mandated vaccines — yet two-thirds of the plaintiffs are turned away from such compensation through vigorous defense of the manufacturers by Justice Department lawyers.
“The drug companies and doctors got all the liability protection they needed in 1986,” says Fisher of the NVIC, “but they are greedy and want more.”
She continues: “It’s a sad day for this nation when Congress is frightened and bullied into allowing one profit-making industry to destroy the Seventh Amendment to the Constitution guaranteeing citizens their day in court in front of a jury of their peers.” Amen to that.
John Hanchette, a professor of journalism at St. Bonaventure University, is a former editor of the Niagara Gazette and a Pulitzer Prize-winning national correspondent. He was a founding editor of USA Today and was recently named by Gannett as one of the Top 10 reporters of the past 25 years.
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