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General Health : Drug News Last Updated: Oct 29, 2008 - 11:04:25 AM


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





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