FDA: 28 Miscarriages No Reason to Reexamine Gardasil

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FDA: 28 Miscarriages No Reason to Reexamine Gardasil

By Fred Lucas

CNSNews.com Staff Writer

December 06, 2007

(CNSNews.com) - Since June 2006, when the HPV vaccine Gardasil was approved

by the Food and Drug Administration, there have been 28 reported cases in

which pregnant women miscarried after receiving the vaccine.

Nonetheless, based on the clinical trials done prior to approval of the drug

- which indicated that miscarriages among pregnant women given Gardasil were

statistically consistent with miscarriages among women given placebos and in

the general population - the FDA remains convinced the vaccine is safe and

is not further investigating its effect on pregnant women.

In May, a 24-year-old woman suffered a miscarriage, which an investigator in

a report issued to the federal government said, " may have been caused by

Gardasil because the patient received the injection within 30 days of the

pregnancy. "

In July, a 17-year-old girl from Texas was unaware she was pregnant when she

got her second dose of Gardasil. She miscarried, but the cause of the

miscarriage hasn't been determined, according to a report.

The reasons for two other miscarriages this year in Florida - one by a

16-year-old and another by a 24-year-old both - are undetermined, according

to reports. But it is known that both women had Gardasil vaccinations

shortly before the miscarriages.

Gardasil is the vaccine to prevent the Human Papillomavirus (HPV), a

sexually transmitted disease and the leading cause of cervical cancer in

women. The package insert for Gardasil states there is " no evidence " the

vaccine will cause " impaired female fertility or harm the fetus. "

Most of the 28 reports of miscarriage, which were drawn from the Vaccine

Adverse Event Reporting System (VAERS), were attributed to " other medical

event. " VAERS reports contain raw, unanalyzed data sent by concerned parties

to the FDA and the U.S. Centers for Disease Control and Prevention.

The only Gardasil side effect the FDA has expressed concern about is

dizziness immediately after the shot, FDA spokeswoman Riley said. " We

ve not seen signals " of a disproportionate problem with Gardasil and

pregnant women, she said.

" If you're pregnant, then it means you've been sexually active, " Riley said.

" So it would be somewhat dubious to get a vaccine you're supposed to have

before you're sexually active. "

While there is no conclusive evidence that any health problems have been

caused by the vaccine, Judicial Watch, the conservative government watchdog

group that obtained the VAERS reports through a lawsuit, is concerned that

the FDA is not scrutinizing the vaccine more closely.

Judicial Watch President Tom Fitton said his group wants to know more about

the FDA's approval of Gardasil and monitoring of potential problems with the

vaccine, which some states either have or are considering mandating for

school girls.

" Merck lobbied for these mandates, " Fitton told Cybercast News Service .

There are moral issues here. But the primary issue is public health and

safety. It's interesting why our government downplays the apparent adverse

reactions of Gardasil. Why are drugs with a distinct social agenda getting

less scrutiny in the approval process? "

Riley stressed that the numbers concerning the pregnancies must be placed in

context.

" Have they (Judicial Watch) compared that to a similar group of young

pregnant women of the same age group who haven't had Gardasil? " Riley said.

There is always a certain percentage of children born with abnormalities

among any sampling. The only way to say if there is a causality relationship

is to compare one group to see if they have a higher rate than another group

"

A total of 3,461 adverse reactions, including eight deaths, were reported to

the government through the VAERS system since the FDA approved the drug.

Reproduction studies were conducted on female rats at doses up to 300 times

the human dose, according to Merck. The tests on the lab rats showed no

adverse effect on reproduction or pregnancy. However, the company literature

on Gardasil said, " It is not known whether Gardasil should be given to

pregnant women. "

During Merck's clinical trials of 2,226 women, half got the Gardasil vaccine

and the other half got a placebo or empty vaccine. In that group, 40 on

Gardasil and 41 on the placebo had an adverse event in their pregnancy.

The most common adverse events were conditions that can result in cesarean

section or premature labor. The portions between the Gardasil and placebo

were comparable, Merck said.

Merck spokeswoman said 2 to 3 percent of the women who became

pregnant during the clinical trials had children with problems, and roughly

15 percent of those had miscarriages. This, she said, mirrors the general

public of pregnant women, regardless of whether they had the vaccine.

Pointing to the fact that VAERS reports are raw data, she said there was

little reason to believe a causal relationship existed.

" It's what you see in the database of the general population, " told

Cybercast News Service . " VAERS are passive reports. It's plausible someone

would get the vaccine, leave the doctor's office and walk into a pole. You

could report that and VAERS would accept it. "

Much of the controversy surrounding Gardasil pertains to the fact that three

states - Massachusetts, New Jersey, and Virginia - are mandating sixth-grade

girls get the vaccine, and other states are considering such a mandate.

The three states included an opt-out provision, which would let parents

choose not to have the vaccine administered to their child for religious or

other reasons.

Meanwhile, 38 other states this year passed or considered some type of

legislation either mandating, funding, or educating the public about the

vaccine, according to the National Council of State Legislatures. New

Hampshire and Alaska adopted a voluntary program that supplies the vaccine

for free to girls between ages 11 and 18 who want it.

Meanwhile, abroad, the British Department of Health approved a national

mandate for school girls to get the vaccine.

After the FDA approved Gardasil, the Advisory Committee on Immunization

Practices recommended routine vaccinations for girls ages 11 and 12. HPV

infects 20 million people in the United States, with about 6.2 million new

cases each year, according to the Centers for Disease Control and Prevention

HPV is responsible for nearly 70 percent of cervical cancer cases.

The American College of Pediatrics and the New England Journal of Medicine

have voiced opposition to mandating the vaccine.