Is this a first step toward a blanket preemption policy in medicine and the pharmaceutical industry by our government representation. These are huge questions that need to be addressed in full public disclosure and debate before making back room deals to get the coveted "Health Care Reform Bill" crammed down the American Public's throat.
Sunday, 26 July 2009
In 2006, PREPA was passed due to fear of an avian flu pandemic, in the event the avian flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate. Yesterday's Infomail focused on the aggressive campaign to vaccinate against the swine flu-- EVEN BEFORE THE VACCINE'S SAFETY, OR THE SAFETY OF THE VACCINE ADJUVANTS HAVE BEEN TESTED.
Below Dr. Meryl Nass (AHRP Board member) provides insight into the serious implications of the broad-based legal immunity given to manufacturers of the flu vaccine under the 2006 Public Readiness and Emergency Preparedness Act (PREPA).
In 2006, PREPA was passed due to fear of an avian flu pandemic, in the event the avian flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate. Faced with such a potentially devastating disease, it perhaps made sense to create legislation to permit rapid deployment of drugs and vaccines without adequate testing, and issue a liability shield for those involved in the process.
But the H1N1 flu has only caused 302 US deaths. The Centers for Disease Control estimated that over one million Americans had been infected with the swine flu. But instead of a 70% death rate, H1N1's death rate is under 0.03%.
Why then have H1N1 vaccine manufacturers been given total legal immunity--as long as they do not deliberately harm consumers of the product?
In applying the 2006 PRPA law, pharmaceutical firms have no financial incentive to make the safest product. Furthermore, in order to avoid having prior knowledge of possible harm to users of the product, for which they could be found liable, it is in the manufacturers' best interest to know as little as possible about adverse reactions caused by their product. Put another way, manufacturers have a financial incentive to follow a self-serving, minimal testing policy that puts public safety at risk.
Should the American public be put at risk by a public health policy that is governed by "don't ask, don't tell?"
Posted by Vera Hassner Sharav
Sunday, July 26, 2009
Legal immunity set for swine flu vaccine makers: What are the implications?
AP Medical Writer Mike Stobbe got a swine flu vaccine scoop--yet the news is
four weeks old. It turns out that DHHS Secretary Sibelius has not only given
immunity to the makers of Tamiflu and Relenza for injuries stemming from
their use against swine flu. She also granted immunity to future swine flu
vaccines and "any associated adjuvants," which was published in the June 25,
2009 Federal Register. Here is the start of his story:
The last time the government embarked on a major vaccine campaign
against a new swine flu, thousands filed claims contending they suffered
side effects from the shots. This time, the government has already taken steps to head that off.
Vaccine makers and federal officials will be immune from lawsuits that
result from any new swine flu vaccine, under a document signed by Secretary
of Health and Human Services Kathleen Sebelius, government health officials
Since the 1980s, the government has protected vaccine makers against
lawsuits over the use of childhood vaccines. Instead, a federal court
handles claims and decides who will be paid from a special fund.
The document signed by Sebelius last month grants immunity to those
making a swine flu vaccine, under the provisions of a 2006 law for public
health emergencies. It allows for a compensation fund, if needed...
However, the compensation issue is more difficult than portrayed by Stobbe.
The special vaccine court to which Stobbe refers applies only to specially
designated vaccines, excludes most adult vaccines, and swine flu is not a
designated vaccine for which compensation can be paid.
The 2006 Public Readiness and Emergency Preparedness Act (PREPA) allows the DHHS Secretary to invoke almost complete immunity from liability for
manufacturers of vaccines and drugs used to combat a declared public health
emergency. PREPA removes the right to a jury trial for persons injured by a
covered vaccine, unless a plaintiff can provide clear evidence of willful
misconduct that resulted in death or serious physical injury, and gets
permission to sue from the DHHS Secretary. There has been no government
funding of its potential compensation mechanism, to date. Furthermore, a
PREPA declaration explicitly shields "government program planners" who
arranged for the liability waiver.
Pharmaceutical companies making swine flu vaccine today may have demanded
immunity from liability before agreeing to begin a crash program to
manufacture H1N1 vaccine for the government. According to a 1978 report by
the National Academy of Sciences, something similar happened with the 1976
swine flu program:
... all manufacturers made plain that they would not insure themselves,
not even temporarily. Instead they put off plans to bottle their vaccine;
pending legislation they would keep the stuff in bulk. Each week's delay in
moving from bulk to bottles assured at least as much delay in starting
inoculations. Thus ended hopes of immunizing anybody in July or even
Behind Merrell's firmness, there almost certainly was fear of the
intentions of the casualty insurers. In May it was no secret that at least
some major firms wanted to steer clear of swine vaccine. As early as April 8
Merck had been warned by its primary insurer that coverage for swine vaccine
was "considered" not "feasible . at virtually any price." So Merck's
President had written Mathews and everyone else in sight.
Merrell, then about to switch insurers (for unrelated reasons) is
reported to have been told by its new one something of the same sort at
about the same time. We do not know precisely what was made of this, where
in Merrell's management. We do know that the issue was reviewed again, in
June, by the insurer with the same result, a "no." But we assume that
Merrell's counsel knew in May what the insurer had already warned in April.
However that may be, it shortly would turn out that all insurers saw the
swine flu program much alike: not for them.
Here is the problem: once the PREP Act is invoked to shield manufacturers
from liability, the pharmaceutical firms have no financial incentive to make
the safest product, and have a negative incentive to test it for safety. As
long as they do not deliberately harm consumers of the product, they will
not be liable for damages.
Are you following this argument closely? In order to avoid having prior
knowledge of possible harm to users of the product, for which they could be
found liable, it is in the manufacturers' best interest to know as little as
possible about adverse reactions caused by their product.
Thus manufacturers can be expected to perform minimal testing, as they have
been incentivized by PREPA to avoid learning of potential harms related to
their product. Thus the speed at which the product will be distributed
serves two purposes: it provides the needed excuse to avoid adequate
testing, as well as providing rapid vaccine availability.
It is worthwhile to go back and consider the reason for passing PREPA in
2006: fear of an avian flu pandemic, if the avian flu virus mutated to
enable person-to-person spread. Avian flu then had a 70% death rate. Faced
with such a potentially devastating disease, it perhaps made sense to create
legislation to permit rapid deployment of drugs and vaccines without
adequate testing, and issue a liability shield for those involved in the rocess.
But the H1N1 flu has only caused 302 US deaths though CDC estimated over one
million Americans had been infected. Instead of 70%, H1N1's death rate is
under 0.03%. Therefore, this virus in no way justifies the risks the
population is being asked to take: receiving vaccines, and perhaps
experimental adjuvants, which their manufacturers have been encouraged not
to test, with no prospect of compensation for illness or death that might
Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W 207 288-5081 ext. 1220
C 207 522-5229
H 207 244-9165
pager 207 818-0708