Merck & Co’s new cervical cancer vaccine Gardasil could be linked to as many as 11 deaths since its approval in the market according to FDA documents obtained by US public interest group Judicial Watch under the Freedom of Information Act (see “New concerns raised over Merck’s Gardasil“).

20-Jun-2007: Information has been received…concerning a 17 year old female who in June 2007…was vaccinated with a first dose of Gardasil…During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died. (Among the new information uncovered by Judicial Watch.)

Whether these deaths are actually attributable to the vaccine or represent “a temporal rather than causal relationship” as Merck claims, they raise again doubts regarding the benefits vs. risks of mandatory vaccination of all young girls, which Merck is still pursuing.

I first raised questions about the benefit of mandatory vaccination in February (see ‘Gardasil: To Be Mandatory or Not To Be Mandatory — That is the Question“).

Like all drugs, risks — whatever they may be — must be weighed against benefits.

On the benefit side of the equation, Gardasil has been dogged by uncertainty about how effective it really is (see “Gardasil Efficacy Questioned“). “Though common in developing nations,” says the WSJ article, “cervical cancer is a relatively rare disease in the U.S., accounting for about 0.7% of cancer diagnoses and deaths each year. Women already have a highly effective method of prevention: visiting a gynecologist for regular Pap tests. The low-tech exam has contributed to an 80% reduction in cervical-cancer deaths in the U.S. over the past 50 years.”

The drug industry is asking consumers and patients to consult with their physicians to weigh their specific benefits vs. risks of taking any drug (vaccines included). If vaccination is mandatory, that kind of conversation with the physician is not an option. Therefore, Merck — IMHO — should encourage voluntary vaccination and stop pushing behind the scenes for passage of mandatory vaccination laws in states.