The makers of Gardasil face a lawsuit in France that claims the human papillomavirus (HPV) vaccine caused a teen to suffer multiple sclerosis. The allegations come as concerns over the safety of Gardasil continue to mount in the United States, although some researchers suggest that media coverage of the problems may be artificially inflating adverse event reports.
The Gardasil lawsuit was filed last Friday against Sanofi and French health regulators. Although Merck manufactures Gardasil, it is sold in Europe by Sanofi Pasteur. The case claims that an unidentified 18 year old French woman, who was only 15 when she received the HPV vaccine, lost the use of her legs and went blind temporarily from Gardasil.
Gardasil is a widely used vaccine for the prevention of certain types of HPV that are sexually transmitted, and which can cause cervical cancer. It was approved by the FDA in 2006, and is widely given to young girls before adolescence and potential sexual activity.
Since it’s introduction, concerns about the safety of Gardasil have emerged after one of the lead researchers responsible for developing the HPV vaccine, Dr. Diane Harper, indicated that the drug’s protection may only last a few years, suggesting that the risks may outweigh the benefits for young girls.
Dr. Harper reportedly said at a conference in 2009, that while Gardasil was tested on 15 year old girls, it is commonly being given to girls as young as nine years old. She has called for more detailed warnings to parents about the Gardasil risks and to provide additional information about the unknown long-term benefits for girls who are not likely to be sexually active for several years.
According to a Reuters report, the lawsuit filed this month in France alleges that the vaccine makers and French health regulators violated “safety obligations” and “principals of precaution and prevention.” Within months of receiving Gardsail, the French teenager indicates that she was hospitalized for multiple sclerosis.
The lawsuit comes just days after a study was published in the Journal of Adolescent Health (PDF) by researchers from South Carolina and Texas, which found a correlation between media reports on potential HPV vaccine side effects and the number of adverse events being reported. The researchers found that even after media interest in the safety of Gardasil waned, interest has stayed high on the internet.
“Public health officials who have long recognized the importance of proactive engagement with news media must now consider strategies for meaningful participation in Internet discussions,” the researchers advised.
Such correlations are often found since experts estimate that only between 1% and 10% of all actual adverse events are reported to the FDA on a regular basis. Heightened awareness has been known to boost those numbers, although in many cases most adverse events are still likely unreported, experts say.
Many health experts strongly support the use of Gardasil, indicating that any risks are negligible and that claims made by those concerned about vaccinations are often not scientifically supported.
The National Cancer Institute has heralded the HPV vaccine, saying that widespread use could reduce cervical cancer deaths worldwide by as much as two-thirds. Many also suggest that men get the vaccine as well in order to promote “herd immunity,” which occurs when a large enough portion of the population is vaccinated against a particular disease that they act as a firewall, preventing that disease’s spread even to those who are not vaccinated.
In response to the lawsuit filed in France, Sanofi officials have said that no studies to date have linked Gardasil and multiple sclerosis, and noted that the condition tends to manifest at about the age of the plaintiff.