- The Washington Post's otherwise excellent article on
the US government's plan to contract for 75 million new doses of recombinant
anthrax vaccine, published March 11, 2004, leaves out some important background:
-
- http://www.washingtonpost.com/wp-dyn/articles/A51691-2004Mar11.html
-
- 1. Apart from the 2001 smallpox vaccine fiasco, no entity
has ever before contracted for nearly a billion dollars' worth of untested
drug or vaccine. Let's explore the Sept-Nov 2001 smallpox contract first.
-
- * Soon after DHHS contracted with Acambis for a total
of 209 million doses of smallpox vaccine, it came to light that the US
actually had a stockpile of smallpox vaccine of between 85 and 105 million
doses.
-
- * It also turned out that the old vaccine had been tested
in college students at various dilutions, and a 20% (1 in 5) dilution yielded
as much protection as full strength vaccine. Thus the existing US stockpile
was sufficient to vaccinate at least 400 million people before any additional
vaccine was purchased. However, that did not stop DHHS from purchasing
nearly a billion dollars of new vaccine, which used the identical virus
strain that was in the older vaccines.
-
- 2. The Acambis smallpox vaccine (209 million doses ordered
before this recombinant vaccine had even been created) is unlikely to ever
be used, barring a smallpox epidemic, since it employs the same vaccinia
virus strain that caused a number of cardiac problems and several deaths
in the 38,000 civilian health care workers vaccinated. (It did the same
in military troops, who are still receiving it, but those deaths have been
covered up--I had a letter published in JAMA [2003;290:2123-4] about this.)
A less reactogenic smallpox vaccine was also ordered by DHHS, for people
who were not expected to tolerate the original vaccine. However, only 15
million doses of this vaccine, called modified Ankara, were purchased.
-
- 3. Acambis's VP Tom Monath was shown by Judith Miller
in the August 7, 1998 NYT to have misrepresented himself as a CDC employee,
rather than a private vaccine developer, in a meeting with President Clinton
in which he pushed hard for production of bioterrorism vaccines. Why did
DHHS contract for smallpox vaccine with a small unknown company that had
been so tarred?
-
- 4. VaxGen (another start-up that is likely to get some
or all of the DHHS recombinant anthrax contract) similarly has been investigated
by the London Times and The Guardian for improper manipulation of its stock
price, has faced several lawsuits by investors, pulled out of a Thai AIDS
vaccine trial when close to completion, leaving its partners very unhappy,
and to my knowledge has never brought a product to market. Why contract
with VaxGen to produce a vaccine created a number of years ago at Fort
Detrick? (I am aware that VaxGen has so far only received $80 million
from DHHS for 3 million doses, but is anticipated to get a much larger
contract for some or all of 75 million doses.)
-
- 5. Vaxgen's own head to head trial of its rPA (recombinant
protective antigen) anthrax vaccine versus the licensed Biothrax/AVA vaccine
showed the recombinant vaccine had over twice the systemic adverse reaction
rate (39% vs 18%) as the original. Yet Vaxgen claimed it compared favorably
in terms of safety.
-
- 6. The WP article is correct in that "many"
postal workers refused AVA in 2001-2: 99% to be exact.
-
- 7. Effectiveness testing of anthrax vaccine in animals
cannot predict human effectiveness. Vaccine effectiveness varies all over
the map depending which experimental animals are chosen. And no correlates
of protection have been identified yet that permit extrapolation from animals
to humans. In fact, in older studies from the 1980s and 1990s performed
at Fort Detrick and Porton Down, UK, rPA vaccines were LESS effective in
animal models than the currently licensed vaccines.
-
- 8. Why rush to order this huge stockpile, which according
to DHHS is not expected to be available until two years after the contract
is signed, when the vaccine shows no strong evidence of being either safe
or effective in humans? There exists no immediate need. Is someone afraid
that complete testing will show up its flaws?
-
- 9. Is the reason for purchasing now, before testing is
complete and licensing assured, to head off development of more promising
approaches, such as Human Genome Sciences' privately developed monoclonal
antibody ABThrax, which reported very positively on an early clinical trial
last week, and derail development of other drugs that are cheaper, more
effective than vaccine and only need be given after an actual exposure,
not before?
-
- 10. Lest anyone be misled that this vaccine is an improvement
on the currently licensed anthrax vaccine, it was selected because it had
been developed a number of years ago at Fort Detrick but never used, ie
it happened to be available when the government decided to replace the
existing anthrax vaccine. It is definitely more pure, but unfortunately
its purity has not been shown to improve safety or effectiveness. There
is no good reason for it to require fewer doses either. In fact, its primary
ingredient, PA (protective antigen) has been demonstrated to have significant
toxicity. For example, injecting it into the cerebrospinal fluid of monkeys
caused complete cessation of brain electrical activity for several minutes,
in studies performed at Fort Detrick in the 1960s, but these studies may
not have been reviewed by those involved with vaccine contracting.
-
- Meryl Nass, MD
- Moount Desert Island Hospital
- Bar Harbor, Maine 04609
- H 207 276-5092
- W 207 288-5082 ext 220 or pager 441
|
