🚀 go-pugleaf

http://ilena-rosenthal.blogspot.com


http://www.cogforlife.org/gardasilmoneytrail.htm
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