Gardasil has been a shot in the arm for pharmaceutical giant Merck. The company had been reeling from the withdrawal of its anti-arthritis drug Vioxx because of increased risk of heart attacks and resulting lawsuits. Now, however, Merck's new vaccine against the human papilloma virus (HPV) — aimed at combating cervical cancer — has been deployed worldwide, earning an estimated $1.5 billion in sales. But the drug is coming under increasing fire from anti-vaccine activists. Already very vocal about childhood innoculations, now they are expressing concern about the effects of Merck's drug on young girls, a primary focus of the company's big ad campaign.
The movement's efforts and propaganda are particularly viral on the web. One story that has been making the rounds for the past week, starting with a report in the Dallas Morning News, concerns Dallas mother Michelle Kimzey, who said that her 14-year-old daughter Katherine, after receiving her second shot of the three-dose vaccine battery in November, experienced headaches, fainting and stiff joints. A few weeks later, she suffered a seizure and later was diagnosed with epilepsy, according to her mother. Kimzey said that she reviewed 5,000 reports filed by the public on a government database website that monitors vaccine safety and became convinced that her daughter's health problems were related to the Gardasil shot. "When you read everybody's stories, they're too similar not to be related," Kimzey told the News. The story has been picked up by over a hundred mainstream media websites and by blogs and chatrooms like vaccinationnews.com.
The government website Kimzey was referring to is VAERS — the Vaccine Adverse Event Reporting System — a program run by the Centers for Disease Control (CDC) and the Federal Drug Administration (FDA). Drug companies are required to report any adverse reactions to VAERS, according to CDC spokesman Curtis Allen, while doctors, patients and parents are encouraged to do so. The CDC regards the VAERS as "an early warning system," Allen said, that allows them to pick up any statistical trend that might indicate a problem. For health professionals, the VAERS system provides some of the best data related to vaccine safety, beyond that provided by the manufacturer, according to Jessica Kahn, M.D., a pediatrician, HPV researcher and teacher at Cincinnati Children's Hospital Medical Center. The danger is that such uninterpreted raw data can also be misused. "It is very important to note," says Dr. Kahn, "that anyone can report a side effect to VAERS, and just because it is reported does not mean it was caused by a vaccine."
For example, a study of VAERS reports of fainting among Gardasil recipients — the medical term is syncope — published in the Journal of the American Medical Association this month did lead to a recommendation that patients should be kept seated or lying down for 15 minutes following the shot. But Allen says reports of other serious side effects, instigated by VAERS datas, have been investigated and the CDC has not found any causal link to Gardasil.
Nevertheless, stories like Kimzey's on Gardasil and other vaccines — many picked up from VAERS reports — continue to fly around the web. "This issue is not going away as more and more vaccines are brought to the market," Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC) who became an activist after a serious reaction in her son to a DPT vaccine (a combined innoculation against Diptheria, Whooping Cough — pertussis — and Tetanus). Fisher, who has served on an Federal Drug Administration consumer advisory committee on vaccines, takes issue with the CDC's read of the VAERS Gardasil reports. Her organization, NVIC, has called on the CDC and FDA to warn the public that Gardasil has been associated with at least 15 cases of Guillain-Barre Syndrome (GBS), an autoimmune disorder; and it says there is an increased risk for GBS when Gardasil is co-administered with other vaccines, particularly Menactra, a meningitis vaccine.
But Dr. Kahn says there no evidence to suggests that the GBS cases reported were caused by vaccination. "Because GBS occurs, though rarely, in young women, it is inevitable that some cases will occur after vaccination by chance and are not caused by vaccination," Dr. Kahn said. "Among 9 to 26 year-olds, the number of reports of GBS received by VAERS are within the range that could be expected to occur by chance alone after a vaccination." Fisher calls that argument a "utilitarian rationale" and said too often the numbers are dismissed as a small sacrifice necessary for the greater good. "How many is too many?" she asks.
NVIC is concerned about the growing number of vaccinations required by schools and the push, in some public health quarters, to mandate more vaccines. The political fight has been taken to New York and New Jersey. New York state public health officials have endorsed state legislation that would take the CDC's recommended vaccine list for children and declare it to be mandatory, Fisher says, and she sees that as a move that should alarm parents. Vaccinations should be voluntary, Fisher says, and be made with "informed consent" by parents. Dr. Kuhn agrees on that point. "Parents should ask any questions that they wish in order to feel comfortable that they have enough information to make a decision about vaccinating their child," she says. "They should bring up any concerns that they have and make sure that all of their questions are answered before agreeing to any vaccine for their child."