Measure Eases Vaccine Rules - Would Shield Manufacturers
By THOMAS D. WILLIAMS,
Hartford Courant Staff
Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people.
The bill would also make it almost impossible for anyone harmed by these substances to sue the manufacturer or drug researchers.
Supporters say protecting producers from potential liability would bring more drug makers to the table. Opponents warn the proposal would render everyone little more than a "guinea pig" for the drug industry.
"[This new] legislation provides liability protection for individuals and entities who engage in countermeasure or pandemic/epidemic technology development, manufacturing or administration," said Michael B. Enzi He is an official with the Biotechnology Industry Organization that represents more than 1,100 biotechnology companies, academic institutions and related organizations.
"Current law," he said, "provides inadequate protections; thus companies have been reluctant to enter the bio-defense market."
"This is a drug company stockholder's dream and a consumer's worst nightmare," said Barbara Loe Fisher, director of the National Vaccine Information Center. "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."
These contrasting views are helping to shape the next phase of the nation's bio-defense program in which seven federal agencies appropriated or spent nearly $25 million between 2003 and 2005.
The measure would give the secretary of health and human services power over what information, if any, the public can know about what drugs people could be made to take against their will. It would also shield manufacturers, universities and other drug research institutions against liability when drug products lead to illness, disability or death.
Had this proposed bill been in place, the six deaths linked to BioThrax, the controversial vaccine the Defense Department bought to protect soldiers against an attack by anyone using airborne anthrax spores, and ordered them to take, might never have been disclosed publicly. The HHS secretary could have decided that the information could harm national security.
The U.S. Food and Drug Administration has been reviewing the deaths of five other service members to determine whether their deaths were also linked to the vaccine.
Information about the drugs' effectiveness or its potential to do harm could not be obtained through normal federal Freedom of Information channels. Manufacturers would be immune from lawsuits arising out of negligence claims in cases where people have been made sick or have died.
Since the public would have trouble obtaining documents proving a drug is causing adverse reactions, Fisher said, there is little chance of challenging a drug company in court.
"The last resort for ordinary Americans who are victims of corporate negligence, is the civil justice system. So, we are against any proposal that leaves people without a just remedy [like this one]," said Erin Mayton, deputy director and counsel of communications for the American Trial Lawyers of America.
The new bill's controversial provisions were discussed over several days inside and outside the Senate Health, Education, Labor & Pensions Committee, which approved the bill.
Doug Heye, a spokesman for U.S. Sen. Richard Burr [R-N.C.], the bill's sponsor, said initial language that would have barred all public access to information has been eliminated. The newer version allows the secretary of HHS to block the release of any information that would hurt national security, he said.
"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," Burr said.
If the bill passes in the Senate, it goes to the House for further action, and if approved there, would need President Bush's signature.
"We feel it is very important to have liability protection for the companies as part of any bio-defense bill," said Allen Abney, a Bush spokesman, who declined to comment on the bill's public information restrictions.
Despite this presidential approval, some doctors believe this bill would turn U.S. citizens into guinea pigs.
"The concept of streamlining product development is left very loose, potentially allowing for any safety requirement to be bypassed," said Dr. Meryl Nass, a Maine physician who has studied experimental vaccines and testified before Congress and in the courts about them.
"This [bill] ignores the Nuremberg Code," said Nass, "in essence requiring American civilians to become guinea pigs for untested products for which their manufacturers have little incentive to assure optimal safety."
Nass said she sees a conflict in the HHS secretary's reviewing of complaints about drugs whose use the secretary authorized by declaring a national emergency. Furthermore, if a drug company disagrees with the secretary's ruling, it could immediately appeal to the federal court.
Connecticut's two Democratic senators have differing opinions on the proposal.
Rob Sawicki, a spokesman for U.S. Sen. Joseph Lieberman, D-Conn., said Lieberman supports Burr's bill and its restrictions on the release of information to protect national security.
Last spring, Lieberman favored passage of legislation giving drug companies protection from lawsuits, tax incentives, drug patent protections and fast track government drug licensing approvals.
"There is no market for these [drugs and vaccines]," said Lieberman, "unless there is a national disaster, so there is no normal market to encourage drug development in this bio-threat area."
The state's other Democratic senator, Chris Dodd, said although the new legislation is sound in attempting to prepare the public for a biological attack, he will not support it in its present form.
"Sadly," Dodd said, "the need for legislation to protect people from biological threats has in crucial respects been placed as a secondary priority behind special protections for special interests in the drug and health care industries. Some limited liability protection is reasonable, but it must be done in a way that doesn't unfairly hurt people affected by potential health crises - or by potential treatments for those crises.
"The bill also gives drug companies exclusive rights to manufacture drugs and vaccines that could increase prices just when people need these drugs most," he said.
Already former HHS Secretary Tommy Thompson has used his emergency powers, created by initial Bioshield legislation, to force voluntary use of BioThrax vaccine for service members. He did so after a federal judge enjoined its mandatory use last April. The vaccine supposedly protects soldiers from enemy attacks by airborne anthrax spores.
BioThrax is manufactured by BioPort Corp. of Lansing Mich. Federal inquiries of its adverse effects show the vaccine can cause lymphoma, lupus, multiple sclerosis, seizures and even death.
U.S. District Judge Emmet Sullivan, acting on complaints that the vaccine was not properly licensed, said the law requires that service members give their consent to be vaccinated.
But Sullivan said he did not have the power to overrule Thompson's emergency vaccine use authorization even though it was issued following Sullivan's ruling. Defense Department lawyers would not tell Sullivan the factual details about the department's basis for asking for Thompson's emergency order saying the details are classified secret. They were, however, able to convince Thompson there is an imminent threat of a biological anthrax spore attack.
In 1998, former Secretary of Defense William S. Cohen ordered forced anthrax vaccine inoculations of all 2.4 million service members. Since then, disputes over its licensing, its safety and the need for its use have been a constant source of public debate.
BioPort's vaccine is utilized almost exclusively for soldiers, has already demonstrated an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use. BioPort is shielded from lawsuits over adverse reactions through a defense department authorization.
Now the HHS is stockpiling the vaccine and other developing drug products, not yet approved, to use on civilians in the event of a terrorist anthrax spore attack. Under initial Bioshield acts passed by Congress in the past two years, HHS and other federal agencies are working on still other new unlicensed drugs and vaccines that in theory will protect the public in the event of a biological attack.
Hartford Courant Staff
Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people.
The bill would also make it almost impossible for anyone harmed by these substances to sue the manufacturer or drug researchers.
Supporters say protecting producers from potential liability would bring more drug makers to the table. Opponents warn the proposal would render everyone little more than a "guinea pig" for the drug industry.
"[This new] legislation provides liability protection for individuals and entities who engage in countermeasure or pandemic/epidemic technology development, manufacturing or administration," said Michael B. Enzi He is an official with the Biotechnology Industry Organization that represents more than 1,100 biotechnology companies, academic institutions and related organizations.
"Current law," he said, "provides inadequate protections; thus companies have been reluctant to enter the bio-defense market."
"This is a drug company stockholder's dream and a consumer's worst nightmare," said Barbara Loe Fisher, director of the National Vaccine Information Center. "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."
These contrasting views are helping to shape the next phase of the nation's bio-defense program in which seven federal agencies appropriated or spent nearly $25 million between 2003 and 2005.
The measure would give the secretary of health and human services power over what information, if any, the public can know about what drugs people could be made to take against their will. It would also shield manufacturers, universities and other drug research institutions against liability when drug products lead to illness, disability or death.
Had this proposed bill been in place, the six deaths linked to BioThrax, the controversial vaccine the Defense Department bought to protect soldiers against an attack by anyone using airborne anthrax spores, and ordered them to take, might never have been disclosed publicly. The HHS secretary could have decided that the information could harm national security.
The U.S. Food and Drug Administration has been reviewing the deaths of five other service members to determine whether their deaths were also linked to the vaccine.
Information about the drugs' effectiveness or its potential to do harm could not be obtained through normal federal Freedom of Information channels. Manufacturers would be immune from lawsuits arising out of negligence claims in cases where people have been made sick or have died.
Since the public would have trouble obtaining documents proving a drug is causing adverse reactions, Fisher said, there is little chance of challenging a drug company in court.
"The last resort for ordinary Americans who are victims of corporate negligence, is the civil justice system. So, we are against any proposal that leaves people without a just remedy [like this one]," said Erin Mayton, deputy director and counsel of communications for the American Trial Lawyers of America.
The new bill's controversial provisions were discussed over several days inside and outside the Senate Health, Education, Labor & Pensions Committee, which approved the bill.
Doug Heye, a spokesman for U.S. Sen. Richard Burr [R-N.C.], the bill's sponsor, said initial language that would have barred all public access to information has been eliminated. The newer version allows the secretary of HHS to block the release of any information that would hurt national security, he said.
"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," Burr said.
If the bill passes in the Senate, it goes to the House for further action, and if approved there, would need President Bush's signature.
"We feel it is very important to have liability protection for the companies as part of any bio-defense bill," said Allen Abney, a Bush spokesman, who declined to comment on the bill's public information restrictions.
Despite this presidential approval, some doctors believe this bill would turn U.S. citizens into guinea pigs.
"The concept of streamlining product development is left very loose, potentially allowing for any safety requirement to be bypassed," said Dr. Meryl Nass, a Maine physician who has studied experimental vaccines and testified before Congress and in the courts about them.
"This [bill] ignores the Nuremberg Code," said Nass, "in essence requiring American civilians to become guinea pigs for untested products for which their manufacturers have little incentive to assure optimal safety."
Nass said she sees a conflict in the HHS secretary's reviewing of complaints about drugs whose use the secretary authorized by declaring a national emergency. Furthermore, if a drug company disagrees with the secretary's ruling, it could immediately appeal to the federal court.
Connecticut's two Democratic senators have differing opinions on the proposal.
Rob Sawicki, a spokesman for U.S. Sen. Joseph Lieberman, D-Conn., said Lieberman supports Burr's bill and its restrictions on the release of information to protect national security.
Last spring, Lieberman favored passage of legislation giving drug companies protection from lawsuits, tax incentives, drug patent protections and fast track government drug licensing approvals.
"There is no market for these [drugs and vaccines]," said Lieberman, "unless there is a national disaster, so there is no normal market to encourage drug development in this bio-threat area."
The state's other Democratic senator, Chris Dodd, said although the new legislation is sound in attempting to prepare the public for a biological attack, he will not support it in its present form.
"Sadly," Dodd said, "the need for legislation to protect people from biological threats has in crucial respects been placed as a secondary priority behind special protections for special interests in the drug and health care industries. Some limited liability protection is reasonable, but it must be done in a way that doesn't unfairly hurt people affected by potential health crises - or by potential treatments for those crises.
"The bill also gives drug companies exclusive rights to manufacture drugs and vaccines that could increase prices just when people need these drugs most," he said.
Already former HHS Secretary Tommy Thompson has used his emergency powers, created by initial Bioshield legislation, to force voluntary use of BioThrax vaccine for service members. He did so after a federal judge enjoined its mandatory use last April. The vaccine supposedly protects soldiers from enemy attacks by airborne anthrax spores.
BioThrax is manufactured by BioPort Corp. of Lansing Mich. Federal inquiries of its adverse effects show the vaccine can cause lymphoma, lupus, multiple sclerosis, seizures and even death.
U.S. District Judge Emmet Sullivan, acting on complaints that the vaccine was not properly licensed, said the law requires that service members give their consent to be vaccinated.
But Sullivan said he did not have the power to overrule Thompson's emergency vaccine use authorization even though it was issued following Sullivan's ruling. Defense Department lawyers would not tell Sullivan the factual details about the department's basis for asking for Thompson's emergency order saying the details are classified secret. They were, however, able to convince Thompson there is an imminent threat of a biological anthrax spore attack.
In 1998, former Secretary of Defense William S. Cohen ordered forced anthrax vaccine inoculations of all 2.4 million service members. Since then, disputes over its licensing, its safety and the need for its use have been a constant source of public debate.
BioPort's vaccine is utilized almost exclusively for soldiers, has already demonstrated an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use. BioPort is shielded from lawsuits over adverse reactions through a defense department authorization.
Now the HHS is stockpiling the vaccine and other developing drug products, not yet approved, to use on civilians in the event of a terrorist anthrax spore attack. Under initial Bioshield acts passed by Congress in the past two years, HHS and other federal agencies are working on still other new unlicensed drugs and vaccines that in theory will protect the public in the event of a biological attack.
