Drug News Studies: HPV Vaccines may not be so effective
By Ben Wasserman
Aug 24, 2008 - 9:33:36 AM
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SUNDAY August 24, 2008 (foodconsumer.org) -- Two cervical
cancer vaccines may not be worth their high cost and both may not be so
effective at preventing the disease in the first place, two studies published
in this week's New England Journal Medicine suggest.
The vaccines of concern Gardasil made by Merck and
Cervarix made by GlaxoSmithKline are designed to prevent cervical lesions
induced by two strains of the human papillomavirus (HPV) from becoming cervical
cancer. Gardasil was approved for marketing in the U.S. two years ago and
Cervarix was approved in Europe years back.
Human papillomavirus is believed to be the major cause
for cervical cancer, which is rare in the United States although the virus is
commonly found in men and women. In 2008, an estimated 11,070 women are
expected to be diagnosed with the cervical cancer and 3,870 will die from the
disease, according to cancer.gov. Most people can clear the virus naturally in
two years without resorting to any medication.
"Despite great expectations and promising results of
clinical trials, we still lack sufficient evidence of an effective vaccine
against cervical cancer," Dr. Charlotte J. Haug, editor of The Journal of
the Norwegian Medical Association, was quoted by The New York Times as writing
wrote in an editorial accompanying the study reports.
"With
so many essential questions still unanswered, there is good reason to be
cautious," Dr. Haug added.
Clinical trials that lasted no more than six and half a
year yielded no evidence that the vaccines render long-term immunity to the
targeted strains and that they would not decrease the body's natural immunity
against other strains that can also induce cervical cancer.
Another study led by Jane J. Kim and Dr. Sue Goldie of
Harvard University showed that girls inoculated with the vaccines at age 12
would cost $43,600 for every life saved by the vaccines during a life time,
which is acceptable to health officials, the New York Times reported.
But if all girls and women up to age 21 are to be given
the vaccines, the cost will be $120,400.
If a booster is required, the cost will rise to $120,400. In these
cases, Pap smear screening will be more cost-effective.
The vaccines do not cover all strains that induce
cervical cancer.
Girls and women who
have received the shots, which can cost anywhere between $400 and $1000 per
person according to the Times , still need to follow the routine pap smear
screening, meaning that the vaccines do not save any money.
Some reports on HPV vaccines are summarized as follows:
Thousands of adverse reactions to cervical cancer vaccine reported Thousands of
adverse reactions to Merck & Co.'s Gardasil, the only cervical cancer
vaccine available in the U.S., have been reported to the U.S. Centers for
Disease Control and Prevention since June 2006, according to media reports. Jul 10, 2008 - 10:40:37 AM
FDA doesn’t okay Merck’s Gardasil used for older women The Food
and Drug Administration denied Merck & Co Inc. request to market the
multi-billion selling cervical cancer vaccine Gardasil to women age 27 to 45
because the agency did not have enough time to address the issues related to
the drug and license application. Jun 25, 2008 - 2:51:09 PM
11 females may die from HPV vaccine The newstarget.com
reported that 11 females have died from Gardasil, the HPV vaccine
intended for use to prevent cervical cancer since the federal
government approved the vaccine last year. Oct 20, 2007 - 1:06:39 PM
Questions raised regarding safety and effectiveness of ‘Gardasil’ Vaccine The Department of Health
and Ageing reported recently “that Australia has the second-lowest
incidence of cervical cancer, and the lowest mortality rate from
cervical cancer in the world".
So why
has a new vaccine for cervical cancer
been introduced with incredible haste? Have the public been presented
with all the relevant information, to enable them to make an INFORMED
CHOICE? Jun 17, 2007 - 3:08:04 PM
HPV vaccine may be more dangerous than thought A new article that appears in the June 9 2007 issue of British Medical Journal
raises questions over the safety of human papillomavirus vaccine named
Gardasil made by Merck and heavily promoted by the government officials
and legislators in the
U.S. and
Australia.
Jun 16, 2007 - 5:02:50 PM
Texas says no to Merck 's cervical cancer vaccine Texas
Gov. Rick Perry said on Tuesday he would not veto a bill that bans
state officials from forcing girls in the state to receive HPV vaccine,
which is claimed by Merck and Co Inc. to be able to prevent girls from
developing cervical cancer. May 8, 2007 - 5:42:21 PM
Merck's HPV vaccine may be more protective than thought It seems that Merck has not found enough of benefits its
human papillomavirus vaccine known as Gardasil can offer, the company has seen new signs
indicating of more protection of this vaccine against cervical cancer,
BusinessWeek reported today. Feb 6, 2007 - 4:34:51 PM
Perry's vaccine order saves lives, but at high price Texas has today decided to
require that all school girls age 11 and 12 receive Merck's human
papillomavirus (HPV) vaccine in an effect to prevent cervical cancer induced by
the virus. Feb 2, 2007 - 3:45:17 PM
Should girls be forced to receive HPV vaccine? Merck is vigorously lobbying state lawmakers to pass
legislation to add its new vaccine against cervical cancer in the list of vaccinations
that children are required to receive to be admitted into school, according to
news reports. Jan 31, 2007 - 11:24:46 AM
Merck's Gardasil protects against more HPV strains (foodconsumer.org) - Merck's cervical cancer vaccine known as Gardasil may protect against more viral strains than previously thought, Reuters reported, citing researchers as saying on Sunday. Sep 3, 2006 - 9:19:00 AM
Merck cervical cancer vaccine gets FDA approval (foodconsumer.org)
- The Food and Drug Administration (FDA) has approved Gardasil, the
first vaccine against four strains of human papillomavirus (HPV), which
can cause cervical cancer, precancerous g enital lesions and genital wa rts. Jun 8, 2006 - 3:36:00 PM