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News of the Day ... In Perspective

5/24/2007

Serious reactions attributed to HPV vaccine

According to a report from Judicial Watch, at least three deaths and 1,600 adverse reactions have been connected to Merck’s new human papilloma virus (HPV) vaccine Gardasil.

Causes of death were myocarditis, coronary artery thrombosis, and pulmonary embolism. Two of the deaths were of girls aged 12 and 19 years. The interval from vaccination to death ranged from several hours to about 2 weeks.

According to Merck and the FDA, the deaths were probably not related to the vaccine. Two of the girls were taking oral contraceptives, and the 12-year-old girl had a heart condition and died of cardiac inflammation brought on by the flu (John Carreyrou, Wall St J 5/24/07). [It is advised to give vaccine before sexual activity begins.]

Serious adverse reactions included paralysis, seizures, Guillain Barré syndrome, and Bell’s palsy.

Reactions classified as "non-serious" included a girl who "stopped breathing later revived" and one described thus: "hives, sent home, found unresponsive by mother, who called 911, revived at ER" (WorldNetDaily.com 5/24/07).

Of the 42 women who received Gardasil while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormalities (ibid.). The denominator, however, may be considerably larger. Merck has a commitment to the FDA to compile a post-marketing registry of women who receive the vaccine while pregnant; more than 300 are listed now, and there are no reports of congenital abnormalities (Carreyrou, op. cit.).

Two to three million women have probably received the vaccine to date. The number of adverse reactions is not considered to be unusually high.

In Australia, controversy has erupted over a federal government initiative to vaccinate every schoolgirl between 12 and 18 with Gardasil. More than 20 girls reported to sick bay after being inoculated at Sacred Heart Girls College, and five were taken to the hospital. A spokesman for the Victorian Department of Health Services said adverse reactions were not uncommon with a large-scale program.

"Parents should remember the benefits of the vaccine far outweigh the side effects," said federal Health Minister Tony Abbott (Australian 5/22/07).

One girl reported paralysis lasting for hours. Reportedly, hundreds of American girls have also reported reactions such as temporary paralysis, fainting, and broken bones from falling after the shot (AdelaideNow 5/22/07).

Australian Medical Association president Mukesh Haikerwal said it was still important for the girls to get vaccinated. "We have got for the first time a vaccine that prevents cancer" (ibid.).

Radio commentator Neil Mitchell deplores the "style of condescension" in the reaction of the medical community: "They are teenage girls, we are told. They are hysterical. They hadn’t eaten breakfast. They are imagining it."

He notes that it is puzzling that several of the girls collapsed hours after the vaccination and in places well removed from each other. While acknowledging that anxiety may have played a role—after all, 70,000 girls received the vaccine without incident—he believes that the patients have a right to demand that they be taken seriously and answered properly.

"What seems so wrong is that too many doctors have been quick to say what the problem was not, without knowing what it was" (Herald Sun 5/24/07).

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