Merck RotaVirus Vaccine Risks

The Associated Press reports that a newly approved, Merck vaccine against rotavirus in infants, has been linked to 28 cases of a life-threatening intestine condition, intussusception.
 
A prior rotavirus vaccine, RotaShield, manufactured by Wyeth, was pulled from the U.S. market in 1999 after it was linked to a small increase in intussusception.

The order, issued on Friday before Super Bowl, mandating all six grade girls
to be vaccinated with Merck's HPV vaccine, Gardasil, is rescinded.
Critics–including AHRP–recognized that  "Perry's end run around the news
cycle and the Legislature is less about women's health than it is about
lobby dollars and commissions."

Indeed, Fox News reported that Merck doubled its spending on lobbyists in
Texas this year, to between $150,000 and $250,000, as lawmakers consider the
vaccine bill for girls entering the sixth grade.
http://www.foxnews.com/story/0,2933,248781,00.html

For Merck, this was an investment worth making. inasmuch as the vaccine is
projected to bring in over a billion dollars annually–multi-billions if
mandatory. Gardasil does NOT prevent all sexually transmitted cancer or
other sexually transmitted diseases. It may potentially lead to INCREASED
cervical cancer if vaccinated women think they are protected and fail to
have PAP smear tests.

Merck's aggressive marketing of Gardasil is a cynical effort to shift the
company's financial burden from its Vioxx lititgation to taxpayers.
Merck's marketing strategy for the HPV vaccine was intended to "Help Pay for
Vioxx."

The public has a right to know the $$ amount Merck spent on lobbying–in
particular how much Merck gave Women in Government to lobby on behalf of
mandatory Gardasil vaccination for girls. Susan Crosby, President of WIG
declined to specify how much the drug company gave.

Merck spokeswoman Janet Skidmore said: "We disclosed the fact that we
provide funding to this organization." She would not say how much the
company is spending on lobbyists or how much it has donated to Women in
Government.

"Ironically, the most enduring thing to come out of this firestorm is
discovering that Executive Orders by Texas Governors carry no force of law.
The Governor directed State agencies to draft rules. They are under no
compulsion to do so. The Governor directed funds be spent on a program. That
power belongs to the Legislature. The Governor tried to direct school
districts to require the vaccine. He has no legal authority to do so.
This may yet prove to be a good idea. But all Perry has done so far is
infuriate allies and enemies alike."

Let this be a warning to all those who attempt to side-step parental rights
and public debate by conducting medical or mental screens–e.g.
TeenScreen–in America's schools. The goal is to broaden the consumer market
for medical products. It is a back door approach of providing unsolicited
medical interventions that expose children to risks of harm.

 

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
~~~~~~~~~

http://news.yahoo.com/s/ap/20070213/ap_on_he_me/rotavirus_vaccine_1
FDA warns of vaccine complications
By ANDREW BRIDGES, Associated Press

The government warned doctors and parents Tuesday of reports of potentially
life-threatening twisting of the intestines in infants vaccinated against a
virus that is the leading cause of early childhood diarrhea.

The condition, called intussusception, is the same that led to the
withdrawal of the first rotavirus vaccine eight years ago.

The Food and Drug Administration said it was unknown whether the recently
approved vaccine, called RotaTeq, caused the 28 new cases. The condition
also can occur spontaneously. Still, the agency said it was issuing the
warning in part to encourage reporting of any additional cases of intestinal
twisting or blockage to help it assess any risks associated with the
three-shot vaccine series.

The vaccine's manufacturer, Merck & Co. Inc., didn't immediately return a
call seeking comment. The 28 cases included 16 infants who required intestinal surgery. There have
been no reports of deaths.

RotaTeq received FDA approval in February 2006. At the time, the FDA and
Merck said trials of the vaccine indicated it did not increase the risk of
intussusception. But Merck and the Centers for Disease Control and
Prevention are conducting follow-up studies of tens of thousands of infants
to track any long-term effects of the vaccine. The FDA also is monitoring reports.

About 3.5 million doses of the Merck vaccine have been distributed in the
U.S., though not all have been used, the FDA said.

The earlier rotavirus vaccine, Wyeth's RotaShield, was pulled from the U.S.
market in 1999 after it was linked to a small increase in intussusception.

In the United States, rotavirus sickens about 2.7 million children younger
than 5, sends up to 70,000 to the hospital and causes 20 to 70 deaths each
year.
___
On the Net:
Food and Drug Administration notification on RotaTeq:
http://www.fda.gov/cber/safety/phnrota021307.htm

~~~~~~~~~~~ 
 http://www.news8austin.com/content/headlines/?ArID=179103&SecID=2
HPV vaccine executive order pushed back
Updated: 2/12/2007 2:58:20 PM
By: Harvey Kronberg
      
   
COMMENTARY — Emotions had just begun to calm in the Texas Legislature after
the bitterly fought speakers race a few weeks ago. But then, Gov. Perry
surprised everyone by ordering all 6th grade girls be vaccinated for HPV.
Perry's executive orders are often major policy announcements that openly
invite debate.

He ordered the Texas Education Agency to devise rules assuring 65 percent of
dollars reach the classroom. He ordered speeding up the permitting process
allowing TXU to build controversial coal fired electric plants.

So, something's wrong when the Governor orders a major mandate late on the
Friday of Super bowl weekend when, presumably, no one was paying attention. 

The order mandates all 6th grade girls receive a new vaccine to prevent HPV,
a sexually transmitted virus with established links to cervical cancer.
Why hide a major public health initiative?

Perry's social conservative base opposes mandating the vaccine arguing it
could promote promiscuity. They also argue more than 500 sixth graders in
Texas get pregnant every year, and the manufacturer says the vaccine could
harm pregnant mother and child.

For some on the left, price is the problem. Friends tell me they paid
$600-$1,400 for the vaccine, only to discover it was not covered by
insurance. The governor showed no interest in negotiating the price with
Merck though it will cost even the state more than $300 each for tens of
thousands of young girls.

Texas' law prevents lobbying the Legislature and getting paid by contingency
fee or commission. However, there is no such prohibition on lobbying
agencies on procuring things like vaccines. Perry seeks to mandate more than
$70 million worth of state purchases. The lead lobbyist pushing the deal is
Mike Toomey, Perry's long time friend and former chief of staff. Cynics
argue Perry's end run around the news cycle and the Legislature is less
about women's health than it is about lobby dollars and commissions, but so
far that suspicion remains speculation.

Ironically, the most enduring thing to come out of this firestorm is
discovering that Executive Orders by Texas Governors carry no force of law.
The Governor directed State agencies to draft rules. They are under no
compulsion to do so. The Governor directed funds be spent on a program. That
power belongs to the Legislature. The Governor tried to direct school
districts to require the vaccine. He has no legal authority to do so.
This may yet prove to be a good idea. But all Perry has done so far is
infuriate allies and enemies alike.

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