Wednesday, December 21, 2005

Holidays Huh?

As the holidays approach and Congress gets ready to adjourn, some
> Senators and Representatives in Congress with financial ties to the
> pharmaceutical industry are trying to pull a fast one on you and your
> family. These same politicians did the same thing in 2002 when they
> tried to
> sneak in liability protection for Big Pharma by inserting the
> thimerosal
> rider into the Homeland Security Bill.
>
> Last night, legislators writing the Department of Defense (DOD)
> Appropriations Bill slipped in language in the Conference Report AT
> THE LAST
> MINUTE giving vaccine manufacturers TOTAL LIABILITY protection if
> experimental vaccines injure or kill citizens whenever the Secretary of
> Health declares an "emergency." That "emergency" could include
> everything
> from a "potential" bioterrorism attack to a potentially bad flu year.
>
> And you may not have a choice about whether or not to take those
> experimental vaccines if your Governor follows the lead of the
> Secretary of
> Health, declares an "emergency" in your state and trots out the state
> militia to arrest, quarantine and forcibly vaccinate you and your
> family.
> Laws passed at the state and federal level since September 11, 2001
> allow
> all of this to happen (go to www.nvic.com and read a letter to Col.
> Robert
> P. Kadlec, M.D., a staffer to Senator Burr which summarizes state and
> federal legislation since 9-11.).
>
> But YOU can stand up TODAY and CALL YOUR OWN SENATOR AND
> CONGRESSPERSON
> and make your voice heard before it is too late. CALL NOW AND PROTECT
> YOURSELF AND YOUR LOVED ONES FROM BEING VICTIMIZED BY DRUG COMPANIES
> AND
> THEIR ALLIES WHO WANT TO ESCAPE ALL RESPONSIBILITY FOR VACCINE
> INJURIES AND
> DEATHS.
>
> To find out who your Senator is, go to www.senate.gov
> To find out who your Representative is go to www.house.gov .
>
> CALL YOUR SENATOR OR REPRESENTATIVE by dialing 202-224-3121.
>
> Every call or fax makes a difference. DON'T GIVE UP! OUR VOICES ARE
> BEING HEARD!
>
>
> http://search.csmonitor.com/search_content/1215/p13s02-uspo.html
> The Christian Science Monitor
> December 15, 2005 edition
>
> 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."

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