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The controversy surrounding the Gardasil vaccine has been around from the moment it was approved for use in young girls. And from the very beginning I have had a problem with Gardasil being referred to as a cervical cancer vaccine – because it’s not. I also have a problem with the ‘fear mongering’ commercials designed to look like public service announcements, and the possibility of making this vaccine (yet another) required by the government.

In the end, I want to research the facts and be the one to make an educated decision about whether or not to vaccinate my daughter for the HPV virus. To be perfectly honest…At this point I don’t see any indication that the benefits of this vaccine outweigh the risks. Although the risks are very small, the benefits seem to be even smaller.

But don’t take my word for it…Look at some of the most recent facts about Gardasil.

From The New York Times – Study Weighs Risks of Vaccine For Cervical Cancer…

“There are not a huge number of side effects here, that’s fairly certain,” said the editorial writer, Dr. Charlotte Haug, an infectious disease expert from Norway, about the vaccine. “But you are giving this to perfectly healthy young girls, so even a rare thing may be too much of a risk.

“I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” Dr. Haug said in an interview. “You don’t have to die from cervical cancer if you have access to health care.”

This is the point I have been trying to make from the beginning of the world-wind push to insist every girl get this vaccine in order to be “one less” person to get cervical cancer.

The FDA and CDC are still claiming that the benefits outweigh the risks of this vaccine. But there is a lot of information for parents to look at before they make the decision to have their child vaccinated.

To start with…When you break the numbers down in this article, it basically says that the small number of “severe” adverse reactions are within acceptable limits…

That was calculated as a rate of 53.9 adverse event reports to the Vaccine Adverse Event Reporting System for every 100,000 doses of vaccine distributed.
. . .
Of the total number of reports, 6.2 percent, or 772 reports, were considered serious events, including 32 reports of death.

As of June 1, 2009, more than 25 million doses of Gardasil were distributed in the United States. So by the looks of it, 6.2 severe adverse reactions for every 100,000 doses is clearly a very low number. And if this vaccine can save lives by preventing a deadly disease like cervical cancer, the benefits must surely outweigh the risks. Right?

But before you can determine whether the risks of the vaccine are acceptable, we need to take a look at the actual risks of cervical cancer.

This is taken from information from the CDC website – Cervical cancer rates in the United States…

For every 100,000 women in the United States – between 3.5 and 12.8 women will develop cervical cancer (that’s about 4-13 women for every 100,000 women, depending on what state you live in). And because we have such effective treatment for cervical cancer in the United States, only between 1.6 and 3.7 women in 100,000 will die from cervical cancer.

So…The risk of death from cervical cancer is even less than the incidence of severe adverse reactions to the vaccine. These numbers seem to indicate that the benefit of not getter cervical cancer is even less than the risk of severe adverse reactions to the vaccine.

To help put the numbers into perspective…

Compare that to breast cancer where 123.8 women for every 100,000 will develop breast cancer and 24.5 of 100,000 will die from it.

Or compare that to the 1 of every 2.5 women who will die of heart disease (the leading cause of death for women).

From The LA Times – Is HPV Vaccine Worth It?

Taking into account both articles is a related editorial. It states: “Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.”

To be honest, I don’t even think these incidences of adverse reactions are the biggest risk to this vaccine. I worry more about the yet unknown problems and long-term issues form this vaccine. It will be at least 20 years before the long-term benefits can be determined. And many believe that this vaccine could cause a decrease in women getting PAP tests, which in turn could contribute to an increase in cervical cancer.

From The American Cancer Society – What are the statistics about cervical cancer?

Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test. This screening procedure can find changes in the cervix before cancer develops. It can also find early cervical cancer in its most curable stage. The death rate from cervical cancer continues to decline by nearly 4% a year.

I really recommend that everyone considering this vaccine for themselves or their child read this article from JAMA – The Risks and Benefits of HPV Vaccine…

The theory behind the vaccine is sound: If HPV infection can be prevented, cancer will not occur. But in practice the issue is more complex. First, there are more than 100 different types of HPV and at least 15 of them are oncogenic (tending to cause tumors). The current vaccines target only 2 oncogenic strains: HPV-16 and HPV-18. Second, the relationship between infection at a young age and development of cancer 20 to 40 years later is not known.
. . .
Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened.
. . .
When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.

Here is some information about Gardasil and the HPV virus you may not be aware of from Dr. Jennifers Info Blog – More HPV Information For Your Family…

Despite company and regulatory assurances, some clinicians, who are also parents, say they are less confident about the safety of the vaccines. After reviewing the information, Scott Ratner, MD, a cardiologist with a practice in Franklin Square, New York, and his wife, a rheumatologist, opted to have their 17-year-old daughter vaccinated. It is a decision they say they now regret.

Following vaccination, their teenage daughter began showing signs and symptoms of autoimmune disease. “She went from being a healthy, active teen, running, playing lacrosse, and participating on swim team to becoming a chronically ill patient,” Dr. Ratner said.
. . .
Gynecologist Christiane Northrup, MD, told Medscape Oncology that she won’t be advocating that her daughters be vaccinated either. Dr. Northrup appeared on a recent episode of the Oprah Winfrey Show, which has an estimated 20 million viewers per week, most of them women. She told viewers that healthcare dollars would be better invested elsewhere.
. . .
Dr. Harper noted that we shouldn’t be calling the new immunizations cervical cancer vaccines. “Even if everyone was vaccinated, we would still have cervical cancer,” she said. “I don’t want people to be lulled into thinking this will prevent cancer. If Pap screening rates decline, cervical cancer rates will rise,” she emphasized.
. . .
“Cervical cancer is not a vaccine-preventable disease,” Dr. Lippman said during an interview. And in her recent editorial, she points out that surrogate end points — not cervical cancer — were used to measure the efficacy in the clinical trials.

“No one would want to wait to see cervical cancer develop in participants,” she writes. “But the general failure to mention that the precancerous lesions chosen for study are not only potentially removable, most (those that are CIN 2) would probably have resolved on their own without any intervention, is arguable.”

From Mama Milton – One Less: Gardasil

I’ve been fumbling around on this page all morning, trying to collect my thoughts and decide whether or not Lexi should complete the Gardasil vaccination series we began last month, in light of some medical concerns about the safety of the vaccine.

What caught my attention? The mention of autoimmune disease, namely RA and Guillain-Barre, two diseases I know too much about to ignore.

So I am left to wonder: What would you do? Would you continue with the series or would you stop while you’re ahead?

Wichita Teen Suffering After Gardasil Vaccine…

Cervical cancer runs in the family, so Wichita teen Gabi Swank asked her mom for the vaccine Gardasil. Swank says the series of shots ruined the life she knew.

This week, new research shows 12,424 girls have had adverse effects to the vaccine. Of that, 772 or 6.2% were considered serious like Swanks.

The kitchen table at Swank’s house is covered with pill bottles. The teen takes 15 prescriptions a day to treat her autoimmune disease lupus. “I get nauseated, I take all of them in the morning and most at night,” Swank said. It wasn’t always like this for the 16-year-old. “After my third shot, that’s when I collapsed and started having chest pains. Dramatically everything changed,” she said.

What is HPV and should my daughter be vaccinated with Gardasil?

As with ANY vaccine, there are risks. You should be well educated on the benefits and risks before receiving this or any vaccine. In my opinion, some parents are worried about the safety of the vaccine and some are worried about the sexual implications. I am an advocate for abstinence until marriage. However, abstinence is not a cure all. My daughter could very well contract HPV from her spouse. She could also contract HPV from non-consensual contact. To be honest, my daughter is 11 and she has not received the vaccine to date. I am a mother who is also conflicted about the safety of the vaccine. I will continue to research and be educated before my daughter and I make this difficult decision.

From CNN – Should your daughter get Gardasil?

When her children were younger, Darrow’s pediatrician urged her to get all the vaccines on the CDC schedule. She noticed, however, that when she told the pediatrician she didn’t want Gardasil for Wendy and Alice, the doctor didn’t push her to reconsider.

“There was no argument, no trying to persuade me, no ‘Here’s a pamphlet about Gardasil,’ nothing,” Darrow says.

Several pediatricians interviewed by CNN said they don’t push the HPV vaccine if parents don’t want it.

“I consider this to be an optional vaccine,” says Dr. Arthur Lavin, associate clinical professor of pediatrics at Case Western Reserve University School of Medicine. “I tell parents it’s fine with me if you wait, and it’s also fine with me if you want that extra added level of protection and we proceed today.”

He said about 15 percent of his patients are getting Gardasil for their 11- and 12-year-old girls.

From Kathlyn Stone – Gardasil controversy pits real moms vs. actor moms…

The National Vaccine Information Center, a watchdog group, has published some reports, but many more mothers’ stories are found in local news reports, on personal blogs, and on other citizen advocacy sites.

Moms are clearly the underdogs in this matchup.

As of today, the FDA has ignored the growing maternal clamor to halt or slow the aggressive promotion of Gardasil.

Many experts, including Harper, the drug’s lead investigator, believe the drug was pushed too rapidly on the public. A process that normally takes three years from application to approval was reduced to six months.

Regulatory and public safety authorities should halt the promotion and lobbying of the drug while it completes a comprehensive and independent (of the pharma company) analysis of the side effects and deaths reported after Gardasil vaccination.

Instead, the FDA appears poised to grant Merck clearance to market the vaccine to boys and older women.

And it’s helping Merck build the case through its blind support of the virgin vaccination program.

Will we see a decline in cervical cancer rates as a result of the tens of millions of Gardasil vaccinations that have already taken place? Since cervical cancer generally appears around age 30, we’ll have to wait another 20 years to find out.

The whole Gardasil controversy only adds to an already fragile relationship between moms and vaccines. Julie from the Chicago Tribune address why some parents question vaccines…

The number of vaccines children receive has tripled since the early 1980s. In 1982, the U.S. Centers for Disease Control recommended 23 doses of 7 vaccines for children up to age 6.

Today’s typical 6-year-old has had 48 doses of 12 vaccines. (Toss in the flu shot, which may or may not be effective, and it boosts the number to 69 doses of 16 vaccines by age 18.)

Immunization against diseases that were once a childhood rite of passage and that conferred lifelong immunity, such as chickenpox, is now required for public school in many states, including Illinois. And the Hepatitis B vaccine is routinely given to babies the day after they’re born, even though the illness is contracted through blood transfusions and sexual activity. Parents wonder: “Why can’t the Hep B vaccine wait?”

I have written a lot about my concerns with the Gardasil vaccine…

The Three Faces of the HPV Vaccine…Fear, Facts, and Profits.

HPV Vaccine Gardasil: Is it safe?

Is The Media To Blame for Over Hyping Gardasil?

Also See:

From Mir Kamin – Gardasil’s Back in the News: Boys need it too?

From Suzanne Reisman – Is Gardasil Right For You?

Cross-posted at BlogHer Health & Wellness