Mandatory Childhood Vaccine Legislation Ignores The
Contaminated Culture That Created It
By Pam Martens
A national furor has erupted over another executive order. This time, it’s
not the President of the United States bypassing the legislative branch of
government to pass laws, it’s the Governor of one of the three most
populated states in the country. Rick Perry, Governor of Texas, has signed
an order making it mandatory for 11 and 12 year old girls to be injected
with a 3-shot regimen vaccine that’s been on the market less than 9 months.
Ostensibly, the vaccine is to prevent some strains of human papillomavirus (HPV)
that may cause cervical cancer, a cancer that occurs annually in less than
one-tenth of one percent of women in the U.S.
The clinical trials for these 11 and 12 year old girls were limited to a few
hundred individuals of this age group and tested only for immune response,
not the efficacy of the drug in preventing the virus or cervical cancer.
The vaccine comes from the big pharmaceutical maker, Merck, which is
currently facing down 27,400 lawsuits (as of 12/31/2006 according to its own
SEC filings ) over another of the drugs the company touted as safe, Vioxx,
just before it was taken off the market due to cardiovascular risk. The
lawsuits allege, and produce damaging internal emails to back their
assertions, that while Merck was telling the public and the Food and Drug
Administration (FDA) about the safety of Vioxx, internal correspondence at
the company was confirming it knew that Vioxx was causing heart attacks,
essentially brushing it off as the cost of doing business and telling its
sales force to “DODGE” questions arising from doctors about these risks.
According to the Wall Street Journal, this is a direct quote from an
internal email from Dr. Edward Scolnick, chief of research for Merck at the
time of the Vioxx subterfuge: In Vioxx, he wrote, “We have a great drug and
like angioedema with Vasotec and seizures with Primaxin and myopathy with
Mevacor there is always a hazard. The class will do well and so will we.”
Experts now believe that as many as 140,000 individuals suffered heart
attacks, strokes and other serious medical complications as a result of
taking Vioxx. This business model of injury and suffering to some for the
benefit of "the class" could certainly be challenged on many ethical fronts.
But only a fool or a conflicted regulatory body would fail to see it as a
cautionary red flag in the implementation of a vaccine for children for a
disease they stand a 1 in 15,000 chance of getting later in life, with no
clinical evidence that the duration of the vaccine will even last that long.
The adequacy of Merck’s internal ethical culture to market vaccines for
children was further called into question in May 2005 when Congress released
Merck’s training manuals for its sales force. The manuals gave the
impression of being authored by a psychotic intelligence operative who
moonlighted as a used car salesman. [*]
While this latest vaccine, which goes by the proprietary name Gardasil, was
being fast tracked for review at the FDA, another government agency, the
IRS, was fast tracking charges that Merck owed the Federal government over
$2 Billion in back taxes. The amount Merck is anticipated to have to pay out
for Vioxx lawsuits and back taxes could wipe out its cash reserves without
an immediate infusion of big sales from some other blockbuster drug. Enter
Gardasil, whose 3-dose regimen will cost a minimum of $360 per student.
With the stakes this high, Merck reached out to a non-profit group called
“Women in Government,” a group funded by it and other drug companies that
stand to benefit from the sale of Gardasil through the use of co-licensing
agreements and royalty payments. On May 18, 2006, when the FDA held its
hearing on whether to approve Gardasil, Kathryn Guccione, an employee of
Women in Government, appeared at the hearing to ask the FDA to approve the
vaccine. (Of the 9 public groups that spoke at the hearing, 6 received
financial support from Merck.)
While acknowledging to the FDA that her organization received funding from
Merck, Ms. Guccione also indicated that her group was responsible for
recently getting 39 states to formally introduce legislation or resolutions
calling attention to preventing cervical cancer. As more and more states
jumped on this fast moving train, Women in Government, which had an
executive from Merck sitting on its Business Council last year, rolled out
the second phase of the project once Gardasil was approved in June 2006. The
second phase was for their members, female state lawmakers across the
country, to introduce the actual legislation that would mandate that six
grade girls receive the Gardasil vaccine in order to enter school. At least
20 states now have this legislation pending, most of it introduced by
members of Women in Government.
I sent an email to Women in Government asking for the specific dollar amount
of funding they had received from Merck. Ms. Guccione responded in an email:
“We leave it up to our supporters if they wish to share specific funding
information.” The organization’s 990 tax form that is publicly available
shows it has received over $5.7 million in total funds for the period 2002
through 2005. It does not list its donors’ names or the amount they have
given.
But Women in Government was the tip of the iceberg. Merck was spending tens
of millions of dollars funding other non profits (who engaged high profile
celebrities), TV advertising and PR firms to create a saturated public
climate ready to embrace a new mandatory vaccine.
And then there were Merck’s acknowledged lobbyists. The Associated Press has
reported that one of Merck’s lobbyists in Texas, Mike Toomey, is the former
chief of staff to Governor Rick Perry. This might help explain why a
conservative Republican Governor would risk a tidal wave of conservative
backlash by skirting the legislative branch to pass an order that is highly
questionable on both a medical basis as well as parental rights.
The real clue may be buried in the hundreds of pages of documents related to
Gardasil that reside on the FDA’s web site. On June 8, 2006, the FDA sent a
letter to Merck approving its license for Gardasil. But there was a caveat.
The FDA wanted more safety information gathered in a new study of 11 and 12
year old girls. The letter said: “…a sufficient number of children 11-12
years of age will be studied to permit an analysis of safety outcomes. The
final study protocol will be submitted by December 31, 2006. Patient accrual
will be completed by December 31, 2008.” This meant that Merck was going to
need to enroll a large number of 11 and 12 year old girls and get the
willing and informed signatures of parents who didn’t know about Merck’s
history with Vioxx before December 2008. Enter the mandatory order from the
Texas governor requiring mandatory vaccinations of sixth grade girls
entering school in September 2008. On its face, this could be interpreted as
a mandatory clinical trial on orders from the Governor of Texas to augment
the inadequate one conducted by Merck.
As jaded as this chronology appears, an equally questionable role was played
by the government agencies mandated to protect the public health.
The day after the FDA held its hearing on Gardasil, it met again to discuss
its future mandates with outside experts. A transcript of that meeting
quotes an FDA associate director of research, Dr. Kathryn Carbone, as
follows: “When I arrived here 10 years ago, in fact, I was instructed never
to mention the word ‘research’ and FDA in the same sentence.” A slide
presented as part of this meeting now lists two goals for the FDA: (1)
“Ensure the safety and efficacy of vaccines and related biological products
for human use;” and (2) “Facilitate the development, evaluation, licensure
and use of new vaccines and related products that positively impact the
public health.”
Why should the FDA be concerned with licensing products for big pharma?
Aside from the stated goal of ensuring the public health, it’s also big
bucks for government workers.
According to the federal government’s Office of Technology Transfer at the
National Institute of Health (NIH), researchers working for the FDA or NIH
and are credited with an invention can “receive the first $2,000 received
from a licensee. Next, they receive 15 percent of royalties received above
$2,000 up to $50,000. Finally, they receive 25 percent of royalties in
excess of the first $50,000 received each year. Each inventor cannot receive
more than $150,000 in royalty payments for a calendar year.”
So the question arises: if you’re a government employee at the FDA and you
know your government colleagues could earn millions over a lifetime for a
drug invention, are you going to shoot down their license application;
especially when your agency is strapped for funds and intramural grants from
these sister agencies are keeping you afloat?
According to the Office of Technology Transfer, it collected $82.7 million
in royalty payments from 882 license agreements or amendments in fiscal year
2006.
And guess where Gardasil originated; in a lab at a federal agency. According
to an Office of Technology Transfer document, “The underlying technology for
the vaccine originated in the laboratories of Drs. John Schiller and Douglas
Lowy of the NIH National Caner Institute (NCI)…Working with the NCI
technology transfer office, the NIH Office of Technology Transfer (OTT)
oversaw the patenting of the VLPs. OTT then sought a suitable [emphasis
added] company with the necessary resources to formulate the vaccine and to
conduct clinical trails. The technology was licensed to Merck….”
And this answers one more question: why was GlaxoSmithKline also funding
Women in Government. It has its own competing vaccine in the pipeline.
According to Merck’s SEC filings (and backed up by NIH documents) “In
February 2005, the Company announced that it and GlaxoSmithKline (GSK)
entered into a cross-license and settlement agreement for certain patent
rights related to HPV vaccines. Pursuant to the agreement, GSK will receive
an upfront payment and royalties from the Company based upon sales of
Gardasil….)
If ever there was a message of hope to those downtrodden FDA whistle blowers
and public citizens calling for an investigation of the regulatory structure
of the FDA, surely this is it. And, hopefully, it comes before a pack of
callous corporate owners of underwater stock options and Washington
bureaucrats stick it to our Nation’s children.
Pam Martens is an
independent writer living in New Hampshire.
[*] Merck's sales
force training manuals and related documents:
http://oversight.house.gov/features/vioxx/documents.asp
http://ahrp.blogspot.com/2007/02/more-about-mercks-help-pay-for-viox.html