Pace Sanders
December 19th 05, 07:20 PM
from the December 15, 2005 edition -
http://www.csmonitor.com/2005/1215/p13s02-uspo.html
Bill to shield vaccinemakers raises alarms
By Gregory M. Lamb | Staff writer of The Christian Science Monitor
A measure to shield drug manufacturers from lawsuits in an effort to
encourage them to develop new vaccines is likely to be quietly attached
to a "must pass" defense appropriation bill within the next few days.
If the US Secretary of Health and Human Services declares that vaccines
were being distributed during a national health emergency, such as a
flu pandemic, the bill would make it very difficult for people who felt
they had been harmed by vaccines to pursue legal action against the
manufacturer.
A broad swath of consumer-rights groups and open-government advocates
had succeeded in slowing the progress of a bill containing similar
provisions sponsored by Sen. Richard Burr (R) of North Carolina. That
measure, introduced in October, would also establish a Biomedical
Advanced Research and Development Agency (BARDA) that critics say would
be exempted from public and congressional scrutiny. Congressional
staffers have been meeting with concerned groups, including a meeting
planned for Wednesday, to revise Senator Burr's bill. A revised version
isn't expected to be introduced until next year, though its future
would be uncertain if the vaccine liability shield is enacted
separately first.
"It looks like the liability-protection language is in [the defense
bill], which will be very difficult for [members of Congress] to vote
against," says Barbara Loe Fisher, president of the National Vaccine
Information Center, a consumer watchdog group in Vienna, Va. Backers of
the liability shield, led by Senate majority leader Bill Frist (R) of
Tennessee, "were very smart in that strategy," says Ms. Fisher, who
calls it "a threat to civil rights, to access to the judicial system,
and to human rights."
The possibility of an avian flu epidemic, as well as the use of
biological weapons, have spurred interest in stepping up production of
new vaccines. Shield-law proponents has argued for years that the
world's giant drugmakers, so-called Big Pharma, would never take much
interest in that arena until they were given strong protections against
lawsuits.
You "want to harness" Big Pharma "to really kick this thing off," says
Christopher-Paul Milne, assistant director of the Center for the Study
of Drug Development at Tufts University in Medford, Mass. "They have
the resources and the expertise and the manufacturing capacity to get
[development of new vaccines] done in a short period of time."
Today, five or six big companies are making vaccines compared with more
than 20 several decades ago, Dr. Milne says. "Some of that is because
of the consolidation of the companies," he says, but some is the result
of the high risk. To attract Big Pharma, "the potential rewards are
going to have to be high," he says. In a national emergency, vaccines
might have to be produced quickly, and perhaps without sufficient
testing. In that kind of high-risk scenario, "you're talking about the
need for liability protection," he says.
Senator Burr's bill, the Biodefense and Pandemic Vaccine and Drug
Development Act, would require plaintiffs to prove "willful misconduct"
by drugmakers. " 'Willful misconduct' is usually pretty egregious
activity," Milne says. "It's going to be hard to sort all that out to a
jury or a judge. It's a pretty high threshold."
"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, characterizing the
bill to the Associated Press last month.
If a liability shield is embedded in the defense bill, it may not
contain secrecy provisions that raised strong protests from
open-government advocacy groups. The Burr bill would nearly exempt
BARDA from the Freedom of Information Act (FOIA) or the Federal
Advisory Committee Act, which reports on the activities of government
agencies.
BARDA would also be screened from the kind of normal cost-accounting
procedures other agencies must follow, says Pete Weitzel, coordinator
of the Coalition of Journalists for Open Government, whose member
organizations include the American Society of Newspaper Editors and the
Society of Professional Journalists. Those groups, along with seven
other CJOG members, signed a letter Nov. 3 asking that the secrecy
measures be stripped from Burr's legislation.
The level of secrecy that BARDA would operate under "is to the best of
my knowledge unprecedented," Mr. Weitzel says. "I don't know of any
other agency in the government that has been given that kind of
authority." Even the CIA and the Defense Intelligence Agency are
subject to some aspects of FOIA, he says.
"[The Burr bill] was breathtaking in its scope in the way it wanted to
completely exclude this new agency from FOIA," adds Lucy Dalglish,
executive director of the Reporters Committee for Freedom of the Press.
Rep. Dave Weldon (R) of Florida, a medical doctor, has been among those
worried that too-strong liability protections for drugmakers might
cause people to hesitate to take vaccines in the event of a pandemic.
In 1976, the government's swine-flu vaccine program collapsed when
public fears spread about potential harm from the vaccine.
In a letter last week to congressional leaders, a group of a half-dozen
consumer advocacy groups, including Public Citizen and the Consumer
Federation of America, wrote: "Broadly shielding [drug] manufacturers
from responsibility for gross negligence, recklessness, and other
egregious behavior, and leaving victims with no recourse, may cause
more public harm than the pandemic disease itself."
http://www.csmonitor.com/2005/1215/p13s02-uspo.html
Bill to shield vaccinemakers raises alarms
By Gregory M. Lamb | Staff writer of The Christian Science Monitor
A measure to shield drug manufacturers from lawsuits in an effort to
encourage them to develop new vaccines is likely to be quietly attached
to a "must pass" defense appropriation bill within the next few days.
If the US Secretary of Health and Human Services declares that vaccines
were being distributed during a national health emergency, such as a
flu pandemic, the bill would make it very difficult for people who felt
they had been harmed by vaccines to pursue legal action against the
manufacturer.
A broad swath of consumer-rights groups and open-government advocates
had succeeded in slowing the progress of a bill containing similar
provisions sponsored by Sen. Richard Burr (R) of North Carolina. That
measure, introduced in October, would also establish a Biomedical
Advanced Research and Development Agency (BARDA) that critics say would
be exempted from public and congressional scrutiny. Congressional
staffers have been meeting with concerned groups, including a meeting
planned for Wednesday, to revise Senator Burr's bill. A revised version
isn't expected to be introduced until next year, though its future
would be uncertain if the vaccine liability shield is enacted
separately first.
"It looks like the liability-protection language is in [the defense
bill], which will be very difficult for [members of Congress] to vote
against," says Barbara Loe Fisher, president of the National Vaccine
Information Center, a consumer watchdog group in Vienna, Va. Backers of
the liability shield, led by Senate majority leader Bill Frist (R) of
Tennessee, "were very smart in that strategy," says Ms. Fisher, who
calls it "a threat to civil rights, to access to the judicial system,
and to human rights."
The possibility of an avian flu epidemic, as well as the use of
biological weapons, have spurred interest in stepping up production of
new vaccines. Shield-law proponents has argued for years that the
world's giant drugmakers, so-called Big Pharma, would never take much
interest in that arena until they were given strong protections against
lawsuits.
You "want to harness" Big Pharma "to really kick this thing off," says
Christopher-Paul Milne, assistant director of the Center for the Study
of Drug Development at Tufts University in Medford, Mass. "They have
the resources and the expertise and the manufacturing capacity to get
[development of new vaccines] done in a short period of time."
Today, five or six big companies are making vaccines compared with more
than 20 several decades ago, Dr. Milne says. "Some of that is because
of the consolidation of the companies," he says, but some is the result
of the high risk. To attract Big Pharma, "the potential rewards are
going to have to be high," he says. In a national emergency, vaccines
might have to be produced quickly, and perhaps without sufficient
testing. In that kind of high-risk scenario, "you're talking about the
need for liability protection," he says.
Senator Burr's bill, the Biodefense and Pandemic Vaccine and Drug
Development Act, would require plaintiffs to prove "willful misconduct"
by drugmakers. " 'Willful misconduct' is usually pretty egregious
activity," Milne says. "It's going to be hard to sort all that out to a
jury or a judge. It's a pretty high threshold."
"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, characterizing the
bill to the Associated Press last month.
If a liability shield is embedded in the defense bill, it may not
contain secrecy provisions that raised strong protests from
open-government advocacy groups. The Burr bill would nearly exempt
BARDA from the Freedom of Information Act (FOIA) or the Federal
Advisory Committee Act, which reports on the activities of government
agencies.
BARDA would also be screened from the kind of normal cost-accounting
procedures other agencies must follow, says Pete Weitzel, coordinator
of the Coalition of Journalists for Open Government, whose member
organizations include the American Society of Newspaper Editors and the
Society of Professional Journalists. Those groups, along with seven
other CJOG members, signed a letter Nov. 3 asking that the secrecy
measures be stripped from Burr's legislation.
The level of secrecy that BARDA would operate under "is to the best of
my knowledge unprecedented," Mr. Weitzel says. "I don't know of any
other agency in the government that has been given that kind of
authority." Even the CIA and the Defense Intelligence Agency are
subject to some aspects of FOIA, he says.
"[The Burr bill] was breathtaking in its scope in the way it wanted to
completely exclude this new agency from FOIA," adds Lucy Dalglish,
executive director of the Reporters Committee for Freedom of the Press.
Rep. Dave Weldon (R) of Florida, a medical doctor, has been among those
worried that too-strong liability protections for drugmakers might
cause people to hesitate to take vaccines in the event of a pandemic.
In 1976, the government's swine-flu vaccine program collapsed when
public fears spread about potential harm from the vaccine.
In a letter last week to congressional leaders, a group of a half-dozen
consumer advocacy groups, including Public Citizen and the Consumer
Federation of America, wrote: "Broadly shielding [drug] manufacturers
from responsibility for gross negligence, recklessness, and other
egregious behavior, and leaving victims with no recourse, may cause
more public harm than the pandemic disease itself."