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Harry Cabluck/AP
Agencies Say Gardasil Safe, But Public Isn’t So Sure
July 24, 2008 11:14 AM
After reviewing thousands of reports of health problems reportedly linked to the HPV vaccine, U.S. officials said that “its benefits continue to outweigh its risks.”
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The Food and Drug Administration and the Centers for Disease Control and Prevention jointly reviewed more than 9,700 cases of health problems that followed Gardasil injections, 6 percent of which were listed as “serious events” including six deaths, Reuters reports.
The most serious adverse affects did not appear related to the vaccine, the agencies said in a joint statement. In cases where an autopsy was available, “the cause of death was explained by factors other than the vaccine.”
But doctors, parents and other members of the public have raised serious questions about the vaccine, which protects against some strains of human papillomavirus (HPV) that cause cervical cancer. Some claim the vaccine has caused severe side effects, including paralysis and even death.
Dr. Diane Harper, one of the researchers who helped develop the drug, said recently that a push by several states and supported by Merck to make the vaccine mandatory for young girls “went too fast without any breaks.”
Harper says there has not been enough postmarketing surveillance of Gardasil to make sure it is not dangerous for girls as young as 11 and 12, who are recommended for the vaccine.
Furthermore, critics worry that Gardasil may be targeting the wrong age group altogether. Middle-school-aged girls who receive the vaccine will be no more than 18 when they pass its five-year proven window of effectiveness.
Additionally, many young women’s immune systems clear the virus within one to two years of contracting it. And when detected early, HPV can be treated and rarely leads to cancer.
The most serious adverse affects did not appear related to the vaccine, the agencies said in a joint statement. In cases where an autopsy was available, “the cause of death was explained by factors other than the vaccine.”
But doctors, parents and other members of the public have raised serious questions about the vaccine, which protects against some strains of human papillomavirus (HPV) that cause cervical cancer. Some claim the vaccine has caused severe side effects, including paralysis and even death.
Dr. Diane Harper, one of the researchers who helped develop the drug, said recently that a push by several states and supported by Merck to make the vaccine mandatory for young girls “went too fast without any breaks.”
Harper says there has not been enough postmarketing surveillance of Gardasil to make sure it is not dangerous for girls as young as 11 and 12, who are recommended for the vaccine.
Furthermore, critics worry that Gardasil may be targeting the wrong age group altogether. Middle-school-aged girls who receive the vaccine will be no more than 18 when they pass its five-year proven window of effectiveness.
Additionally, many young women’s immune systems clear the virus within one to two years of contracting it. And when detected early, HPV can be treated and rarely leads to cancer.
Headline Link: Gardasil popular despite concerns
“There was not a common pattern to the deaths that would suggest they were caused by the vaccine,” the FDA and CDC statement said. Gardasil is one of Merck’s top-selling products but its sales have decreased recently. On July 21, Merck projected 2008 Gardasil sales of between $1.4 billion and $1.6 billion, down from its prior projection of $1.9 billion to $2.1 billion.
Source: Reuters
Background: Controversy over HPV vaccine
Among the thousands of complaints about “adverse effects” surrounding Gardasil, two girls have alleged in court that the vaccine made them sick. One of them, Oklahoma resident Jesalee Parsons, got the shot in February, at age 13, and says she developed a fever and chest pain after receiving the vaccine.
Source: CNN
“We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” Dr. Diane Harper said of potential plans to mandate Gardasil for young women.
Source: News Inferno
Related Topics: Gardasil given too young; STDs in teenagers; the abstinence issue
A February 2007 story in The Washington Times explored the idea of the HPV vaccine being given to the wrong age group. Gardasil is proven to be effective for five years, and cancer experts have worried that if it is given at too young an age it will wear off too soon, not protecting women from exposure to the virus once they reach their 20s. The typical cervical cancer patient doesn’t contract the virus until more than a decade after her preteen years, and cancer does not appear, on average, until age 47, following an incubation period.
Source: The Washington Times
A CDC study released in May suggested one in every four teenage girls has an STD. HPV, which can cause cervical cancer, is by far the most prevalent.
Source: findingDulcinea
When Texas legislators, as well as lawmakers in other states, considered making Gardasil a mandatory vaccine last year, there was opposition from parents and others concerned that requiring a vaccine for an STD would complicate the idea of teaching abstinence to teens.
Source: The Dallas Morning News
Opinion & Analysis: Weighing the pros and cons
Researchers have not yet confirmed whether Jenny Tetlock became almost totally paralyzed as a direct result of receiving the Gardasil vaccine, or from something else with coincidental timing. Deborah Kotz writes for U.S. News & World Report that the incident raises some concern, even though the vaccine provides major benefits: “As a parent, I’ve wrestled with whether or when to get my 12-year-old daughter vaccinated against HPV. As much as vaccines are vital in protecting against life-threatening infectious diseases, they do, indeed, have the potential to cause harm…I’m not sure whether Jenny’s case has changed my opinion about the value of Gardasil. But it certainly has given me pause.”
Source: U.S. News & World Report
Reference: Cervical cancer statistics; STDs
According to the American Cancer Society, cervical cancer most often occurs in women in midlife, with most cases found in women under 50 and rarely developing in women under 20. Almost 20 percent of women are diagnosed with cervical cancer when they are over 65. Over 3,000 women will die from cervical cancer in 2008, but the Pap test is responsible for the cervical cancer death rate declining by 74 percent between 1955 and 1992. The death rate continues to decline about 4 percent a year.
Source: American Cancer Society
The findingDulcinea Web Guide to STDs and STIs provides information about STD prevention, testing and support groups.
Source: findingDulcinea
SourceWatch is a Web site whose stated mission is to document the public relations efforts of companies; it has compiled a report on Merck, including its efforts concerning Gardasil.
Source: SourceWatch
© 2008 Dulcinea Media, Inc.
