The Centers for Disease Control and Prevention (CDC) is renewing its push to have more 11- and 12-year-old children of both sexes be vaccinated against cancer-causing strains of human papillomavirus (HPV), despite continuing concerns about its safety and opposition by many parents.
The CDC will hold an Aug. 30 news conference -- the third in as many months -- to release more data on the effects of the vaccines. The CDC is asking physicians to "strongly recommend HPV vaccines, starting with patients who are 11 years old," when visiting physicians' offices to receive other vaccines.
But opponents say the CDC plan is to essentially mandate the inoculation of all children against a virus that has lasting effects for only a small portion of the population with a vaccination that has raised safety concerns. Parents have also questioned the need to inoculate such young children for a sexually transmitted disease.
A study, published in Pediatrics, found that an increasing number of parents are refusing to have their girls be vaccinated -- rising from 40 percent in 2008 to 44 percent in 2010. The number of parents concerned about the vaccine's side-effects more than tripled, from 5 percent to 16 percent during the same period.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC) told Newsmax, "Our concern is this aggressive push by the Centers for Disease Control and by medical trade organizations … toward a mandating of this vaccine for all children."
"In the 1960s when the polio vaccine was introduced and distributed through the school systems, mothers wanted that vaccine for their children. There was no huge outcry for HPV vaccine," Fisher said.
Two vaccines are used against four of the 150 varieties of HPV, Gardasil, produced by Merck & Co. Inc., and Cervarix, produced by GlaxoSmithKline, which has been approved by the Federal Drug Administration for use in females as young as nine for the prevention of cervical cancer. The CDC in 2011 began recommending the vaccine for boys who might be susceptible later in life to anal, penile, and mouth and throat cancer.
NVIC and others have expressed concerns over the safety of the vaccines.
"As of July 2013, there have been 27,908 Gardasil adverse-event reports filed with VAERS [Vaccine Adverse Event Reporting System], including 126 deaths, more than 10,000 emergency room visits, over 2,500 hospitalizations," Fisher said. Another 12 death reports in VAERS have been associated with Cervarix.
Fisher charged that those 27,908 negative reactions may represent "only 10 percent of Gardasil adverse events that have actually occurred … because 90 percent of all Gardasil adverse events have never been reported to VAERS."
The CDC and the manufacturers say it is necessary to put the number of adverse reactions into perspective considering the large number of vaccines given.
"With the 56 or 57 million doses of HPV vaccine in this country, and even more in other countries -- we don't have safety concerns about the vaccine," said Dr. Anne Schuchat, director of the CDC National Center for Immunization and Respiratory Disease.
The drug manufacturers, the FDA, CDC, and other organizations say the HPV vaccines are safe and that there are no serious side effects from their use, beyond a higher incidence of fainting associated with Gardacil, requiring vaccinated recipients to spend 15 minutes under observation before being released.
"It is important to understand that VAERS accepts reports from anyone, whether the information is verifiable or not," CDC spokeswoman Darlene M. Foote told Newsmax. "It is also important to understand that VAERS cannot determine if a reported adverse health event was caused by one or more vaccines."
In response to Fisher's accusations and opposition from others, Foote said, "Thousands of men and women die each year from HPV associated cancer. We now have a safe and effective vaccine that can prevent HPV infection. We owe it to our children to do all that we can to protect them so they can grow up to be healthy adults."
Coleen Kivlahan, senior director of health systems innovation and policy at the American Association of Medical Colleges, told Newsmax, "If adolescents are unlikely to be sexually active with multiple partners, wait until marriage, or use condoms consistently, they may be able to do without the vaccine. Otherwise if your daughter lives in the U.S. and acts as most teens do, the vaccine is the best option."
But the National Cancer Institute (NCI) suggests that most people who have HPV suffer few consequences from contracting the virus.
While HPVs can cause genital warts and others are associated with cervical and throat cancers, most people will never know they have HPV because they have no symptoms and their immune system inactivates the virus, "with the result that in nearly 90 percent of people, the immune system clears the HPV infection within [two] years," says a NCI fact sheet.
In addition, having the vaccination does not end the need for women to receive regular Pap tests that detect cervical cancer.
Which is another reason NVIC sees the heavy push for HPV vaccine as unnecessary. "Cervical cancer in this country dropped more than 70 percent among women after the introduction of routine Pap screenings in women's health programs in this country in the 1960s and 1970s," Fisher said.
But Foote, the CDC spokeswoman, told Newsmax that 18 percent of women, or over 16 million, reported not having a Pap test in the last three years. "Generally, Pap testing is very effective, but no screening test works 100 percent of the time," she said.
The vaccine is big business for its manufacturers with Gardasil sales now totaling $1.6 billion annually, a 65 percent rise from 2010.
"We really have to take the blinders off and understand that the pharmaceutical industry, like every industry that's in the business of making and selling product, their goal is to sell a lot of product," Fisher said. "What is unsettling to me -- after working on this issue for 30 years -- is to see how much more taxpayer money is being spent by government health agencies to assist the pharmaceutical industry in selling their vaccines."
Merck had attempted to have the drug mandated by the states, but pulled back on that effort in 2007 "after groups including the American Academy of Pediatrics said there wasn't enough state funding to pay for the $360 vaccine or public acceptance," according to a Bloomberg article.
Concerns have also been voiced that Gardasil was fast-tracked through the FDA approval process at the request of Merck. Fast-tracking vaccine approval is a process authorized by Congress that is initiated by the manufacturer, and in Fisher's view has led to deficiencies in the testing of Gardacil.
CDC Director Tom Frieden said last month that at the upcoming August press conference they would share data that will "include vaccination coverage estimates for HPV vaccinations among boys, something that's only more recently been recommended."
While touting the efficacy of the vaccines, Frieden lamented that the number of teen girls completing the three-dose vaccine series dropped from 34.8 percent in 2011 to 33.4 percent in 2012.
"This is a huge disappointment, but I'm confident that we will turn it around," he told reporters.
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