Trusting the Government for... Vaccine Safety and Need

[news item about upcoming economic manipulation of vaccine programs]

<http://www.washingtonpost.com/wp-dyn/articles/A51691-2004Mar11.html>

 

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:

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 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 MD was said 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 startup 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 reactions (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 carefully crafted
improvement on the currently licensed anthrax vaccine, it was developed a
number of years ago at Fort Detrick and 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.

11. There is no reason to believe that immunity will last any longer with
this vaccine than with the old anthrax vaccine (an estimated one year before
boosters are required).

12. In a nutshell, this vaccine is NOT the result of research into how to
make a safer vaccine.

13. The theory on which this procurement is based hypothesizes that a major
US city could be contaminated with anthrax, but its population could be
vaccinated and continue to live there. This theory has many flaws: no
vaccine is 100% effective, and immunity decreases over months to years.
Life in such a city could not go on unaffected because vaccinated people
WOULD die: first, those who did not generate enough immunity from
vaccination, and later others as the vaccine's effects wore off.
Vaccination will not solve the problem of anthrax contamination.

14. The other obvious problem with this theory is that an enemy can create a
vaccine-resistant anthrax, as was done by the Russians in the early 1990s.

15. In the past two years researchers at Harvard and in France have shown
that adding other antigens to PA greatly increases the effectiveness of
anthrax vaccine. However, the "new" rPA vaccine was developed before this
discovery and does not contain these extra antigens.

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
H 207 276-5092
W 207 288-5082 ext 220 or pager 441