Nausea to paralysis -- even death from new vaccine

(CNN) -- A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil has been the subject of 7,802 "adverse event" reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis -- even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV -- a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine's manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006.

Two girls allege in court that the vaccine made them sick.

One -- Jesalee Parsons of Broken Bow, Oklahoma -- got the shot at age 13.

Jesalee's lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

"I just feel let down by the government," Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report "does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination."

Merck said it would continue to evaluate reports of adverse reactions. It said it "updates product labels with new safety information as appropriate."

Merck to Stop Pushing to Require Shots

Wednesday, February 21, 2007; B10

Merck and Co., a New Jersey-based pharmaceutical maker, announced yesterday that it would stop its nationwide lobbying for states to require that young girls be immunized against a virus that causes cervical cancer.

Merck officials said the decision comes after public accusations that the company's profit motive, rather than public health, is guiding the debate over whether to require rising sixth-grade girls to receive Gardasil. The new vaccine protects against several strains of human papillomavirus that cause nearly 7,000 cases of cervical cancer annually.

"Our goal is preventing women from getting HPV and cervical cancer," said Richard M. Haupt, executive director of medical affairs for Merck's vaccines division. "What's unfortunate is that our role appears to be a distraction to that goal."

Merck, the drug giant best known for making Singulair for asthma and Zocor for lowering cholesterol, received federal approval for Gardasil in June. Since then, it has lobbied lawmakers in many states, including Virginia and Maryland, for requirement of the vaccine. The District also is considering a requirement.

This month, Texas became the first state, among about 20 considering legislation, to require girls to be vaccinated.

Because Gardasil is intended to halt the spread of a sexually transmitted disease, concerns have been raised among politicians and parents that a mandate might encourage promiscuity. And requiring the vaccine, which costs $360 for a series of three shots, would make Merck hundreds of millions of dollars annually.

The retreat's effect is unknown in Virginia, where lawmakers in both houses of the General Assembly have approved Gardasil mandates. Gov. Timothy M. Kaine (D) has yet to sign on, and spokesman Kevin Hall declined to comment on the governor's position.

State Sen. Janet D. Howell (D-Fairfax), who pushed for the bill, said she is comfortable with the public health benefits of mandating Gardasil. But she agreed that Merck's lobbying role complicated efforts to make that case.

In Maryland, a proposed mandate was withdrawn after objections. New legislation is pending that would set up a task force to study the matter for two years.

A number of prominent public health organizations, including the American Cancer Society and the American Academy of Pediatrics, have recommended that girls receive the vaccine.

But these groups stopped short of pressing for the mandate that Merck wants. Some say they are not ready to endorse a mandate so soon after the vaccine gained Food and Drug Administration approval.

http://www.washingtonpost.com/wp-dyn/content/article/2007/02/20/AR2007022001335.html