Vaccine Damage Immunity for Drug Companies

Senate Moves Towards Forced Vaccinations, Vaccine Damage Immunity for Drug Companies
Associated Press | December 2, 2005
By ANDREW BRIDGES

RELATED:
Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Introduced in Senate)[S.1873.IS]

Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Reported in Senate)[S.1873.RS]

CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES



By creating a federal agency shielded from public scrutiny, some lawmakers think they can speed the development and testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.

The proposed Biomedical Advanced Research and Development Agency, or BARDA, would be exempt from long-standing open records and meetings laws that apply to most government departments, according to legislation approved Oct. 18 by the Senate health committee.

Those exemptions would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill. The legislation also proposes giving manufacturers immunity from liability in exchange for their participation in the public-private effort.

"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Sen. Richard Burr, R-N.C., said when the Committee on Health, Education, Labor and Pensions approved the bill.

The agency would provide the funding for development of treatments and vaccines to protect the United States from natural pandemics as well as chemical, biological and radiological agents.

But it is the secrecy and immunity provisions of the legislation that have alarmed patient rights and open government advocates. The agency would be exempt from the Freedom of Information and Federal Advisory Committee acts, both considered crucial for monitoring government accountability.

"There is no other agency that I am aware of where the agency is totally exempt either from FOIA or FACA," said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government. The coalition is an alliance of journalism groups, including the American Society of Newspaper Editors and Associated Press Managing Editors, that wrote to lawmakers seeking amendments to the bill. "That is a cause for major concern and should raise major policy concerns," Weitzel said.

Burr spokesman Doug Heye said the provisions would keep competitors from gaining proprietary information through FOIA. However, confidential business information already is exempt from FOIA.

"There's no secrecy involved in BARDA," Heye said. "That is absolutely false. This is an agency that will be putting out information daily."

Some Democrats question whether the public would accept drugs or vaccines developed in conjunction with the agency, citing the abortive 2003 effort to vaccinate 500,000 front-line health care workers against smallpox. Only about 40,000 workers ultimately received the vaccine amid concerns about the vaccine's safety, which health authorities initially downplayed.

"Republican leaders in Congress are now proposing a plan that would make exactly the same mistake," Sen. Chris Dodd, D-Conn., said in a statement. "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."

The bill does provide for limited compensation. However, another provision would grant drug companies immunity unless "willful misconduct" can be shown.

The Pharmaceutical Research and Manufacturers of America said it was reviewing the bill. Another industry group, the Biotechnology Industry Organization, declined comment.

The National Vaccine Information Center, an advocacy group, called the legislation "a drug company stockholder's dream and a consumer's worst nightmare."

The proposed law comes amid growing concern about pandemics and the government's ability to meet such threats. For instance, the United State needs another three to five years to develop the manufacturing capacity to produce 300 million doses of flu vaccine, Health and Human Services Secretary Mike Leavitt said Sunday on NBC's "Meet the Press."

The agency would improve on Project BioShield, a barely two-year-old program also meant to encourage production of vaccines and drugs, Heye said.

"While some progress has been made, we still haven't seen the participation from companies, universities and research institutions in developing vaccines we might need to protect us from the next threat, whatever that might be," Heye said. "One of the reasons is (they) don't want to put their very existence on the line."

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the agency as proposed would represent a setback to decades of progress in opening up to the public the process of testing the safety and efficacy of drugs.

"These provisions are extremely dangerous," Wolfe said. "The fact that they are being proposed, really exploiting people's fears about pandemics and epidemics, is outrageous and goes backward on the progress on the use of the Freedom of Information Act and Federal Advisory Committee Act to increase public scrutiny and increase the correctness of decisions that are made."

Republican and Democratic lawmakers alike agree the drug industry needs some protections to encourage it to produce emergency stocks of vaccines and drugs, but Democrats have balked at providing blanket immunity without first establishing a compensation fund for patients.

Republicans are pushing for liability protections for vaccine manufacturers on other fronts as well. Senate Majority Leader Bill Frist, R-Tenn., is seeking to add such protections to a defense appropriations bill.

Frist spokeswoman Amy Call said drug company concerns about liability are real.

"There's really no financial incentive for them to get into the market, sell to the government at a reduced rate and then open themselves up to losses that could potentially bankrupt them," Call said.

The push for liability exemptions may force the Burr bill to the sidelines until the next session of Congress, Republican and Democratic aides said. But Call said Frist intends to pursue the legislation.

CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES

National Vaccine Information Center | October 16, 2005

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.