JAMA Article Slams Gardasil Marketing

An article just published in the Journal of the American Medical Association (JAMA) criticized <"http://www.yourlawyer.com/topics/overview/gardasil_side_effects">Gardasil maker, Merck & Company, for its marketing of the controversial vaccine geared to young girls, the Wall Street Journal reported. Among other claims, the article faulted Merck’s financial backing of medical groups, which did not offer an equitable picture of Gardasil’s efficacy and safety, said the Journal.

Gardasil is a vaccination that prevents some forms—not all forms—of the Human Papillomavirus (HPV) that cause cervical cancer. Some of the controversy surrounding Gardasil involve attempts by Merck to make the inoculations mandatory, and because of continuing questions about the drug’s safety. It is widely known that those injected with the cervical cancer vaccination have experienced greater fainting and blood clot reactions versus people receiving other types of vaccinations, the Journal pointed out.

In June, the U.S. Food and Drug Administration (FDA) announced that Gardasil’s label was updated to include more prominent warnings about fainting that can occur following administration of the vaccine. Some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries, according to the FDA; about 13 percent of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

The JAMA piece, as well as a related safety study piece, about Gardasil raised issues concerning safety, efficacy, and marketing tactics, especially given that some experts have questioned the medication’s cervical cancer fighting abilities, said the Journal, which noted that the drug’s approval was for two, not all, strains of cancer-causing HPV. Worse, noted the Journal, the vaccine was not broadly tested; only a “few hundred 11- and 12-year-old-girls” were involved in the test group, said the Journal. Some feel that this number was insufficient to declare the drug safe for that demographic.

Merck has also been long criticized for its ongoing fights to require HPV vaccination in a variety of states, something from which it finally eased in 2007, said the Journal.

This June we wrote about how over two dozen women and girls died in 2008 after receiving Gardasil injections and that, according to Judicial Watch, 47 deaths have been linked to Gardasil. Judicial Watch says it obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, up from 19 in 2007. Of 47 deaths reported since 2006, Judicial Watch said 41 occurred within a month of the vaccine; of those, 17 were within two weeks of receiving the vaccine.

The group said—citing VAERS—that the FDA documented 6,723 “adverse events” related to Gardasil in 2008, of which 1,061 were considered “serious,” and 142 considered “life threatening.” Since last June, 235 cases detailed permanent disability, with 29 new cases of Guillain-Barre Syndrome and 147 cases of “spontaneous abortions,” or miscarriages, when the vaccine was given to pregnant women, Judicial Watch said. Judicial Watch also documented 62 cases of Gardasil recipients who developed warts after receiving the vaccine. In additional to genital warts, there were 21 reports of girls developing warts on other areas, including face, hands and feet, and, in one case, “all over her body.” Despite these findings, the American health authorities who managed the safety review continue to assert the vaccine’s safety, claiming its benefits outweigh its risks, said the Journal, noting that JAMA described Merck’s marketing of the drug “pushy” and “disturbing,” it quoted.

Merck’s sales of the drug have dropped in the past year and Merck has been unable to gain favor among older teenagers and young women, but continues in its efforts for a version of the drug targeted to males, said the Journal.

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