Merck's Gardasil linked to 3 cases of Pancreas Disease

Important News from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com

http://www.smh.com.au/news/national/...307309515.html

Louise Hall, Health Reporter
August 17, 2008
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THE cervical cancer vaccine is under fresh scrutiny after three women
were struck down with pancreatitis soon after receiving the injection.

The Therapeutic Goods Administration (TGA) is investigating whether
the shot of Gardasil caused the sudden inflammation of the pancreas in
the three patients, or whether it was just a coincidence.

A 26-year-old woman went to Bankstown Hospital four days after
receiving her first dose of the quadrivalent vaccine, which protects
young women from the strains of human papillomavirus (HPV) that cause
70percent of cervical cancers.

Writing in the Medical Journal Of Australia, surgery fellow Amitabha
Das said the woman developed a fever, rash, severe pain and vomiting
and was diagnosed with pancreatitis. After 10 days the symptoms
settled and she was discharged from hospital and remains well.

Dr Das and his colleagues said an extensive investigation could find
no other cause for the pancreatitis and while a coincidental illness
could not be ruled out, "neither can HPV vaccination be excluded as a
potential cause".

"We suggest that pancreatitis be considered in cases of abdominal pain
following HPV vaccination," they wrote.

A spokeswoman for the TGA said in the second case, the patient's level
of pancreatic enzymes normalised within 24 hours. A third woman is
still under the care of a gastroenterologist.

Acute pancreatitis is a sudden, debilitating attack of severe upper
abdominal pain. Pancreatic enzymes irritate and burn the pancreas, and
leak out into the abdominal cavity. Complications include respiratory,
kidney or heart failure, all of which can be fatal.

Rachel David, spokeswoman for Gardasil manufacturer CSL, said the firm
remained confident the drug was safe and effective, but the reports of
pancreatitis would be immediately investigated.

"No causative relationship with the vaccine has been established but
obviously we do take reports of associations like this very
seriously," Dr David said.

The TGA has received 1013 reports of suspected adverse reactions to
Gardasil, including soreness, swelling, redness or other reaction at
the injection site (20percent), headaches (20percent), dizziness
(15percent), nausea (16percent) and vomiting (6.9percent).

It said the overall level of reporting for Gardasil, following the
distribution of 3.7million doses in Australia, was very low and
consistent with other new vaccines and rates reported from other
countries.

Meanwhile the federal program to cover the cost of three doses of the
vaccine expires in June. The two-year program provided free Gardasil
immunisation delivered by GPs for women aged 18-26 and girls 12-18 who
missed out on the injections at school.

Once the program ends, Gardasil will cost $150 a dose, or $450
overall, on a private script.

The school-based program for girls aged 12-13 will continue but
funding for older students will finish at the end of the year.

http://ilenarose.blogspot.com
Health Lover


Human Papillomavirus (HPV) DNA March 7, 2007
http://www.fda.gov/OHRMS/DOCKETS/DOC...01-01-vol1.pdf


Since the 1990's, medical
science has confirmed that most of the HPV infections, even caused by
the so-called "high-risk"
HPVs, are self-limiting. Only persistent infection caused and
maintained by certain genotypes of
HPV, often with low intracellular viral load, is truly of "high risk"
to the host in causing
precancerous lesions of the cervix .

3) Most women who become infected with HPV are able to eradicate the
virus and suffer no
apparent long-term consequences to their health . But a few women
develop a persistent infection
that can eventually lead to pre-cancerous changes in the cervix [1]

"Most women who become infected with HPV are able to eradicate the
virus and suffer no
apparent long-term consequences to their health . But a few women
develop a persistent infection
that can eventually lead to pre-cancerous changes in the cervix ."
". . .most infections are short-lived and not associated with cervical
cancer."

4) Most infections are short-lived and not associated with cervical
cancer [1] .

5) Persistent HPV infection, not the HPV virus itself, is the pivotal
promoter in causing cervical
precancerous lesions and cancer [8-11] . Most of HPV infections, even
caused by "high-risk"
genotypes, are transient with normal Pap cytology in sexually active
young women [4-7] . In 93%
of initially infected women, the same viral type is not detected upon
re-examination four
menstrual cycles later [20] . The median duration of positivity
detectable by PCR for a specific
HPV type in these young women is 168 days [21] .

8) Injection of HPV vaccines into women who have concurrent
vaccine-relevant HPV type
infections evidenced by sero-positive and PCR-positive tests may
increase the risk, by about
44.6%, of developing high-grade precancerous lesions in the cervix
[14] .

http://ilenarose.blogspot.com
Health Lover


Human Papillomavirus (HPV) DNA March 7, 2007
http://www.fda.gov/OHRMS/DOCKETS/DOC...01-01-vol1.pdf


Since the 1990's, medical
science has confirmed that most of the HPV infections, even caused by
the so-called "high-risk"
HPVs, are self-limiting. Only persistent infection caused and
maintained by certain genotypes of
HPV, often with low intracellular viral load, is truly of "high risk"
to the host in causing
precancerous lesions of the cervix .

3) Most women who become infected with HPV are able to eradicate the
virus and suffer no
apparent long-term consequences to their health . But a few women
develop a persistent infection
that can eventually lead to pre-cancerous changes in the cervix [1]

"Most women who become infected with HPV are able to eradicate the
virus and suffer no
apparent long-term consequences to their health . But a few women
develop a persistent infection
that can eventually lead to pre-cancerous changes in the cervix ."
". . .most infections are short-lived and not associated with cervical
cancer."

4) Most infections are short-lived and not associated with cervical
cancer [1] .

5) Persistent HPV infection, not the HPV virus itself, is the pivotal
promoter in causing cervical
precancerous lesions and cancer [8-11] . Most of HPV infections, even
caused by "high-risk"
genotypes, are transient with normal Pap cytology in sexually active
young women [4-7] . In 93%
of initially infected women, the same viral type is not detected upon
re-examination four
menstrual cycles later [20] . The median duration of positivity
detectable by PCR for a specific
HPV type in these young women is 168 days [21] .

8) Injection of HPV vaccines into women who have concurrent
vaccine-relevant HPV type
infections evidenced by sero-positive and PCR-positive tests may
increase the risk, by about
44.6%, of developing high-grade precancerous lesions in the cervix
[14] .