Participants in the Gardasil studies were monitored for, at most, four years and many for a considerably shorter time frame. The largest trial is scheduled to be ended early and the people who were given a placebo now will be given the vaccine, meaning it's no longer possible to study long-term differences in health between those who received the vaccine and those who received the placebo.
In terms of long-term safety, one sentence in the FDA's insert is particularly revealing. "Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity," according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We don't know because researchers didn't look. The trials were not set up to examine that question.
Additionally, five participants in the trial who were given the vaccine near the time of conception went on to give birth to babies with birth defects versus zero cases of congenital anomalies in the group that received the placebo. This is hopefully not an issue for many 11-year-olds, but it could impact teenagers and certainly young women who get the vaccine. The insert states that Gardasil is not recommended for use in pregnant women, but are pregnancy tests going to be routinely given before the vaccine is administered? Only time and widespread use will reveal whether those five babies born with birth defects reveal a pattern.
As a condition for Gardasil's approval, Merck agreed to monitor the "pregnancy outcomes" of women who receive the vaccine while unknowingly pregnant, along with general safety issues. But drug companies have had a poor track record on actually completing the post-licensure follow-up studies required by the FDA, according to the agency's own figures.
The FDA announced in March that two-thirds of those promised studies had not even been started, and hundreds of trials have been pending for years. The agency has little leverage to force the companies to comply, according to a report by the Government Accountability Office. In many of those cases the companies received expedited approval from the agency on condition that the studies be carried out. Gardasil was approved on just such an expedited timeline.
So if this vaccine turns out to have safety issues are we even going to know? Or is it going to remain on the states' mandatory list long after many girls suffer serious side effects or worse?
What about the safety of giving Gardasil at the same time as the meningococcal and diphtheria, tetanus and pertussis vaccines, shots 11- and 12-year-olds receive during the same visit to the doctor? Merck looked at the safety of administering the HPV vaccine at the same time as Hepatitis B, but what about the safety of concurrent vaccination with DPT, or any other combination of vaccines the kids could be "caught up" on during that visit?
The CDC's vaccine advisory committee also said the vaccine could be given to girls as young as nine, at the direction of the physician. The rationale for doing so is that the vaccine is only effective prior to exposure to HPV and actually leads to increased risk of precursors to cervical cancer in those previously infected, so it's best to catch girls as early as possible. Yet only 250 9-year-olds received Gardasil in trials, adding to the unknowns about administering a vaccine on still developing bodies.
Shouldn't parents be permitted to weigh such considerations when making health decisions for their children?
Merck had an enormous amount at stake in making the shots mandatory. A place on states' required lists means a steady and exponentially larger revenue stream. Financial analysts predict Gardasil could be Merck's most important pipeline contributor to top-line growth, with peak sales of at least $2 billion -- revenue Merck badly needs after the Vioxx scandals. That revenue figure assumes that states will make Gardasil mandatory.
The CDC's support also all but guarantees insurance reimbursement, as well as state and federal funding. Perhaps more importantly, it also gives Merck coverage under a federally funded vaccine liability program. If Gardasil turns out to have devastating or deadly consequences, Merck isn't liable.
"It's a stockholders dream," said Barbara Loe Fisher, president of the NVIC, a nonprofit that promotes right to informed consent on vaccine decisions. Fisher sat on the FDA's committee that reviews vaccines in 2001, when the vaccine underwent early reviews.
"This has nothing to do with kids and whether they are going to have sex," Fisher added. "It has to do with whether they are going to be set up for chronic inflammatory disease" from yet another vaccine being added to the litany of those they already receive. "I would want more data on long-term effects of autoimmunity on certain genotypes," she said in an interview, "and whether this vaccine is going to harm far more girls than it is going to protect."
In a recent study published in the journal Pediatrics, 35 percent of parents surveyed were against having their children vaccinated for HPV. Safety was their primary concern. Although the study didn't specifically look at whether that resistance was tied to a fear that the shot would make their kids more likely to have sex, are we really going to deny parents the right to make an informed choice?
Beyond touting the misleading public-health argument, many progressive organizations have asserted that leaving HPV off the CDC's recommended schedule means that the resulting lack of public funds will prevent many poor kids from having access to it. If that's the only objection, then another public funding avenue could be devised to get the vaccines to those who want them and couldn't otherwise afford the $360 price tag.
Yet, at its core, the argument for mandatory use is really about something else. It was recently summed up aptly, if inadvertently, by Joe Kernan, anchor of CNBC's Squawk Box. He moderated a segment last month on whether Gardasil should be mandated. He said:
Suzanne Nelson is a freelance journalist and writer living in New Orleans. She spent five years covering Congress for Roll Call Newspaper in Washington, D.C., and now focuses on subjects pertaining to health.
She also maintains a health blog at honesthuman.com.
