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THE HYPE AND THE HIDDEN BEHIND HPV VACCINES

Sr. Pilar Verzosa, RGS
August 30,2007

In her column “A new vaccine to save women’s lives” (Inquirer, 8/28/07), Rina Jimenez-David reports that Cervarix, a vaccine against the sexually-transmitted human papillomavirus (HPV) developed by GlaxoSmithKline, was recently launched in Manila following the launch last year of Gardasil, another HPV vaccine developed and marketed by Merck. Cervarix and Gardasil, which are being marketed with a lot of media hype, are touted to be 100% effective against certain strains of HPV, believed to be responsible for some 70% of cervical cancers.

In the United States, Merck is aggressively pushing to have the FDA-approved Gardasil mandatory for all children as young as nine who attend public schools. “Pre-teens have very robust immune responses to vaccines,” argues a Merck’s spokesperson. So far, Virginia and Texas have signed bills making Gardasil mandatory. Cervarix, on the other hand, has still to be approved in the U.S. and the EU.

Merck’s PR blitz comes as no surprise considering that Gardasil has an annual peak revenue potential of from $2B to $4B, assuming that states will make it mandatory.

But inoculating pre-adolescent girls for a sexually-transmitted virus has raised many concerns for parents, patient advocates, and Christian groups, becoming the biggest vaccine ethics issue getting public attention in the US today. For example, a survey of 1,600 mothers and fathers published in the journal Pediatrics found that 35 percent are against having their child inoculated. Rightly so, their protests rest on fundamental issues of necessity, safety, ethics, and morality.

For one thing, these drugs work against 4 out of 100 HPV strains, and only 2 out of these 4 strains affected by this drug have been related to cervical cancer. These are drugs that affect a small subset of viruses that are transmitted through sexual contact. Thus, if a young girl is not going to have sex, there is no reason for her to be given the drug. In addition, Barbara Loe Fisher, president of the National Vaccine Information Center questions the need for a mandatory HPV vaccine when regular pap smears on women could catch the HPV early before it develops into cancer.

In the last six months of 2006, Vaccine Adverse Reporting System (VAERS) received 385 cases on adverse effects of Gardasil requiring additional medical attention, a third of which were children 16 years and younger. VAERS is a programme co-sponsored by the FDA and the Center for Disease Control. In a worst case scenario, the Washington-based Judicial Watch reported the deaths of three young women, the youngest only 12 years old, tied up to the use of the vaccine.

Ms. Fisher’s further statement on the safety of vaccines is likewise disturbing. She observes that American kids’ vaccine doses against various diseases have doubled since the 1980s, and during that time, there has been an increase in the number of autism, attention deficit and hyperactive disorder, learning disabilities, asthma, and diabetes in which vaccines could be a contributing factor.

In the meantime, the Texas Catholic Bishops Conference has asked the Texan governor to rescind his executive order making Gardasil vaccine mandatory. Their statement cites parental concern about their daughters’ innocence, the possibility of encouraging promiscuity, and giving young girls a false sense of security regarding sexually transmitted disease. Echoing Ms. Fisher, they suggest that it is not the only avenue for disease prevention. Indeed, as the bishops emphasize, the most effective way to avoid contracting the virus is to abstain from sexual relations before marriage and to remain faithful within the marriage. And like the Concerned Women of America, they maintain that the choice to have a child immunized against HPV must ultimately rest with the parent.

And yet, through all the public debate on this very important issue, the Philippine Bureau of Food and Drug, having approved the marketing of Gardasil last year, have, once again, recently approved , post-haste, the marketing of Cervarix, making the Philippines the only one so far among the Asian countries to do so.

Following these approvals, Ms. David reports that in the Philippines, there is some discussion as to whether these HPV vaccines should be included among the “basic” immunological drugs that are covered by state health systems.

Before we allow these big pharmaceuticals to foist these drugs upon us, it is perhaps wise and prudent to first look into the hidden truth behind the media hype so we can address the issues raised by those who, like the United States, have learned some lessons from past experience.

For truly, is HPV vaccine good for our children? Or, as Ms. Fisher so aptly puts it, is this just “profit-making on the backs of nine-year-old girls?”


References:

1. Magazines:

Celebrate Life. Jim Sedlak. “None Dare Call It a Conspiracy.” May-June 2007.

Fortune. John Simons. “Merck’s $4 billion PR Problem.” June 5, 2006. Accessed from on August 30,2007 http://money.cnn.com/2006/06/02/news/companies/pluggedin_fortune on August 30,2007

Life Lines. FLI Staff. “What You Should Know About Gardasil.” July-August 2007.

2. Newspaper Articles/Columns

EWTN News. “Bishops wary of Vaccine Mandate for Preteens, Urge Governor to Leave Decision in Parents’ Hands.” February 23, 2007 (Zenit.org News Agency). Accessed from www.ewtn.com/vnews/getstory.asp?number=76181 on August 30, 2007.

EWTN News. “ Mandatory HPV vaccination overrides parental rights, say Christian groups.” February 6, 2007 (Catholic News Agency). Accessed from www.ewtn.com/vnews/getstory.asp?number=75584 on August 30,2007.

Philippine Daily Inquirer. Rina Jimenez-David.”A new vaccine to save women’s lives.” August 28, 2007.

3. Website Articles

“GSK submits cervical cancer vaccine for EU approval.” March 9, 2006. Accessed from the University of Pennsylvania Center for Bioethics website (www.vaccineethics.org/labels/Cervarix.html ) on August 30, 2007.

 
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