MOUNTAIN
VIEWS: FORCED INOCULATIONS BEGINNING OF BUSH'S BAD BIRD FLU PLAN
By John Hanchette
OLEAN
-- Last week's column
warned of imminent federal legislation that would toss powerful
pharmaceutical companies billions of dollars and complete
protection from liability suits in case untested and
experimental bird flu vaccines damage American recipients. It
drew heavy response.
The bill (S. 1873)
-- a big congressional wet kiss to the drug industry -- is
dressed up in a noble-sounding title: "Biodefense and
Pandemic Vaccine and Drug Development Act."
In essence,
however, it would force Americans to receive inoculations
against a disease that has yet to kill one of them, while
removing their constitutional right to seek redress in our
courts in case of injury or death from the shots because of
company negligence. The proposal, now moving its way through the
Senate, would also ban citizens from using the Freedom of
Information Act and other popular informational laws to discover
whether the new vaccine (when it is finally produced) was
effective and safe, and even whether anyone had suffered adverse
reactions to it.
Some of the e-mails
and letters were laudatory, but sadly and predictably, many
readers missed the point.
One wrote that I
could only have reached my conclusions if I started from the
position that the pharmaceutical companies were "evil"
and that the World Health Organization, the Centers for Disease
Control, and "practically every virologist and
epidemiologist in the world is part of a conspiracy." Or
was I saying that I have "some sort of privileged
information that H5N1 influenza will never mutate and begin to
infect humans and even if it does, it won't reach the USA?"
He ended by quoting
some venerable Chinese philosopher's advice to "plan for
what is difficult while it is easy, do what is great while it is
small."
Well, yes, point
taken on the aphorism -- but that's exactly the philosophical
tack I'm following here: identifying a cancerous piece of
federal business and dissecting it while it is still an
undivided cell. If this bill -- which is absolutely laden with
hidden agendas -- metastasizes into actual law, Senate 1873
could further ruin an already devastated national health care
system.
Sure, the bird
influenza that has killed 62 Asians may mutate into easily
contractible flu for humans. I acknowledge that. It may soon
reach the United States. I acknowledge that. But my beef is the
thematic hidden agenda in this dangerous Senate bill that is
designed to protect wealthy corporate contributors from any
consequences of money-motivated, irresponsible scientific
research and development. The legal precedent would be ruinous
and take decades to set right.
One thing the
bill-backer friends of Big Pharma are trying to slip through
with this legislation is a market exclusivity provision that
would extend patents on hugely profitable drugs that are about
to evolve into the category of cheaper generic medicines.
Further, it would
prohibit federal drug buyers from contracting with generic
medicine makers to save taxpayers billions of dollars -- a
current admirable practice.
Further, it would
allow federal health officials to purchase medicines, vaccines
and other palliatives by simple fiat without taking bids.
Further, and most
onerously, the bill would vastly broaden the definition of
products eligible to be characterized as
"countermeasures" to terrorism -- in other words,
potentially classifying commonly purchased substances like
ibuprofen and aspirin as terrorist-fighting devices.
I'm not the only
one who's noticed the exclusivity aspect of this legislative
turkey.
The Coalition for a
Competitive Pharmaceutical Market (CCPM) is an unusually
broad-based national coalition of organizations powerful on
Capitol Hill in representing employers, health insurers, chain
drugstores, generic drug makers and pharmacy benefit managers.
Last week, this
huge group urged the Senate to revise the "biodefense"
bill to remove the broadened definition of terrorism
"countermeasures" because the proposal allows it to be
done "in a way that could grant existing everyday medicines
-- rather than novel products related to (defense) against
bioterrorism -- multiple years of additional market
exclusivity."
This, contends CCPM
chairman Annette Guarisco, "would unnecessarily drive up
prescription drug costs for private and public payers without
advancing our nation's bioterrorism preparedness."
Even the big health
insurance companies and pharmaceutical management lobbyists were
startled by the brazen provisions at the expense of common
citizens Senate 1873 portends.
Mark J. Rubino,
chief pharmacy officer for Aetna Inc., states, "For private
and public purchasers seeking to provide consumers with
therapeutically equivalent, but more cost-efficient generic
drugs, the market exclusivity provision included in the
Biodefense bill takes us in exactly the wrong direction."
Mark Merritt,
president of the Pharmaceutical Care Management Association,
said, "This drug monopoly extension proposal is a sweeping
and unprecedented measure that would rewrite drug-patenting and
force working families, the disabled, and seniors to pay more
for their prescription drugs. Perhaps most troubling of all,
this measure has moved forward without any regard to the cost
(effects) it would have on on Medicare, Medicaid, and private
payers. America's working families, seniors, and small
businesses deserve better."
Some who read the
column accused me of overstating the liability protections for
Big Pharma contained in the bill. Surely, they wrote, I was
guilty of hyperbole or making things up. Surely, federal
legislators wouldn't remove the cherished American right to
redress wrongs or seek compensation for uninvited injury.
Oh, yeah? The
language seems pretty clear to me. It provides incredibly broad
and iron-clad protection from any American seeking legal remedy
from Big Pharma and just about everyone else involved in
protecting against bird flu. Look up the draft bill's Section
319F-3 (a) if you don't believe me.
"Authority --
As provided in subsection (b), and subject to subsection (b) (1)
C, a manufacturer, distributor, or administrator of a security
countermeasure, or a qualified pandemic and epidemic product, or
a health care provider shall be immune from suit or liability
caused by or arising out of the design, development, clinical
testing and investigation, manufacture, labeling, distribution,
sale, purchase, donation, dispensing, prescribing,
administration, or use of a countermeasure, or a qualified
pandemic and epidemic product, described in subsection (b) (1)
(a)."
That just about
covers the waterfront, as they say. The only avenue of relief an
injured vaccine or medicine recipient or survivor could follow
is requesting an investigation of their allegation by the
Secretary of Health and Human Services -- who would have to find
"clear and convincing evidence" of "willful
misconduct" that "caused the product to present a
significant or unreasonable risk to human health and proximately
caused the injury alleged by the party."
There are at least
seven tough legal tests contained in that one paragraph. And if
the HHS Secretary refuses to even investigate the complaint of
injury or death, such decision is completely "within the
Secretary's discretion and shall not be subject to judicial
review."
If the secretary
does find for the complaining injured party -- which is
extremely unlikely -- the drugmaker or distributor or health
care provider named in the determination can petition the
federal court in the District of Columbia for "judicial
review" of the HHS ruling. But no subpoenas shall be
issued, "nor shall other compulsory process apply,"
and no third parties can intervene. The drug company appeal
"shall automatically stay the Secretary's determination for
the duration of the judicial proceeding."
There are six more
pages of legal gobbledygook backing this up, one of them
defining the scope of protection from lawsuit as extending to
allegations "relating to, or resulting from the design,
development, clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation, dispensing,
prescribing, administration, or use of product" defined as
measures against pandemics or terrorism. There, is that specific
enough for you? Is that an imaginative figment?
Interpretation of
this congressional language: Pigs will fly backwards and upside
down before the common citizen gets any redress or compensation
for injury or death resulting from a bird flu vaccine or
medicine.
Why are vaccine
safety advocates so adamant that John Q. Public might get
screwed by all this protect-Big Pharma bird flu legislation?
Because it has happened before.
In the 1970s, the
panic over swine flu led to an ill-advised vaccine push that
crippled many recipients and cost the drug makers millions.
In the 1980s, a
dangerously reactive vaccine against whooping cough injured and
killed thousands when a safer foreign alternative was already
available but stubbornly unapproved by the FDA.
In the 1990s, the
federal health establishment insisted -- and still insists --
there is no connection between toxic mercury preservatives in
mandated childhood vaccines and the astounding increase in
autism (from 1 in 10,000 births to 1 in 166 births), despite
ample scientific evidence to the contrary.
Experimental
anthrax vaccine is still being tested on troops without informed
consent, and was almost tested on infants until a big public
fuss erupted.
The yearly hoohah
over getting your flu shots to protect against contractible
human flu results in less than desired protection because the
scientists are always fighting the previous year's struggle that
has already mutated or died out.
Both the federal
government and big pharmaceutical firms will go to almost any
length to protect themselves from blame when vaccines are
involved.
Now we read the
government experts and private researchers are predicting a
minimum of 200,000 deaths and perhaps as many as 2 million
deaths if the Asian bird flu mutates into a disease that can be
passed from bird to human and then human to human.
"This is
shoddy science at best and beyond belief that any reputable
scientist could get away with such nonsense," writes Dr.
Joseph Mercola, an alternative health physician and author of
the popular Total Health Program. "Most of the people (in
Asia) who acquired this infection were bird handlers who were in
continuous contact with these sick birds. Does anyone in their
right mind envision similar circumstances in the United
States?"
The issue is
certainly timely. This column's date of publication (Tuesday,
Nov. 1) will see President George W. Bush go to the National
Institutes of Health to tell us how he will spend -- at his
executive discretion -- nearly $8 billion that was quickly added
to the 2006 funding bill for HHS last Thursday in light of the
concern over bird flu. He is expected to devote much of it to
stockpiling vaccines once they are developed. The federal
government has already committed to buying $162.5 million worth
of experimental vaccines against the bird flu strain -- doses
which may or may not protect humans -- from Chiron Corp. and
Sanofi-Aventis. The feds are also ordering millions of doses of
Relenza and Tamiflu, two human anti-flu drugs that seem to slow
down the advance of bird flu but not completely halt it.
Meanwhile, the best
possible outcome -- that the H5N1 bird flu strain fizzles out or
never mutates to threaten humans -- is triggering a new concern
among federal officials: that all the frantic warnings so far
may have created a sense of public cynicism (or at least
skepticism) over global health admonitions about pandemics.
"Will critics
say we have been crying wolf?" worried HHS Secretary
Michael Leavitt at the end of last week. Will the public
"lose the sense of urgency we feel about this issue?"
Well, maybe, Mr.
Secretary. But Americans would lend you a lot more credence if
you ensured they were treated fairly.
John Hanchette, a
professor of journalism at St. Bonaventure University, is a
former editor of the Niagara Gazette and a Pulitzer
Prize-winning national correspondent. He was a founding editor
of USA Today and was recently named by Gannett as one of
the Top 10 reporters of the past 25 years. He can be contacted
via e-mail at Hanchette6@aol.com.
