More Doctors Say Gardasil Shouldn't Be MandatoryNov 12, 2008 | Parker Waichman LLP
Increasingly, experts are agreeing that the government should not mandate Gardasil immunization for girls. Merck’s Gardasil was approved two years ago and is prescribed for girls aged nine-to-26 to protect against sexually transmitted diseases caused by four Human Papilloma Virus (HPV) strains responsible for 70 percent of cervical cancers and 90 percent of genital warts. Since Gardasil’s approval, the government has received over 10,000 reports of adverse events and 27 deaths reportedly linked to the controversial medication.
In the Journal of Law, Medicine & Ethics, three academics—Gail Javitt of Johns Hopkins’s Berman Institute of Bioethics, Deena Berkowitz of George Washington University School of Medicine, and Lawrence Gostin of Georgetown University Law Center—contend state and local governments should not require girls receive Gardasil vaccinations. The three cite public health and constitutional reasons saying that Gardasil does not address the same level of public health threat as existing mandates for polio, measles, and other childhood vaccinations. Because of this, they note, courts will likely not uphold the constitutionality of a mandate for vaccination against HPV. “We should be careful about adding more and more vaccine requirements when they exceed the original purpose of mandatory, school-based vaccinations,” Javitt said, recommending instead that states educate parents about the benefits “because it will allow parents to make informed decisions without coercing them.”
Controversy over Merck’s lobbying of states to require vaccination led it to cease those attempts and prompted governments to lean more toward education and funding efforts. Merck spokeswoman Amy Rose announced that Merck stopped lobbying for Gardasil school-requirements and is focused on educating policy and lawmakers looking at Gardasil use about HPV, cervical cancer, and the vaccine. “Merck’s goal is to ensure that Gardasil … is used to its fullest appropriate extent to help reduce the burden of cervical cancer and other HPV-related diseases in the United States,” Rose wrote.
Gardasil was sped through US Food and Drug Administration (FDA) approval after a brief six-month period. Critics, including scientists, have long wondered if Gardasil’s benefits are outweighed by its serious and sometimes fatal risks, saying it is only modestly effective and its safety has not been adequately proved. After just one injection a 13-year-old girl was diagnosed with Acute Pancreatitis, has spent nearly 100 days in the hospital, and underwent two surgeries to remove Pseudocysts. Her family just filed a petition for vaccine compensation seeking damages from the government. A group of Australian researchers found that young women there who received Gardasil were five to 20 times likelier to suffer rare and severe allergic reactions. In the U.S., a 20-year-old woman suffered a stroke after receiving a second Gardasil injection. Two women oversees died after receiving their Gardasil injections and those deaths followed the deaths of three other young women who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Another 13-year-old began showing signs of having been stricken with a degenerative muscle disease after her third Gardasil injection; she is now almost completely paralyzed.