FDA: 28 Miscarriages No Reason to
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 Karen 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 Jennifer Allen 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," Allen 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.