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Gardasil Researcher Says Better Warning on Side Effects Needed

Aug 20, 2009 | Parker Waichman Alonso LLP

A lead Gardasil researcher says more complete warnings should be given to patients before the vaccine is administered.  In an interview with CBS News, Dr. Diane Harper also criticized Merck & Co.'s aggressive marketing of the Gardasil.

As we've reported previously, Dr. Harper has dedicated two decades of her career to research on the Human Papillomavirus (HPV), the virus that causes cervical cancer.  She served as a researcher on study trials for Gardasil and another HPV vaccine, Cervarix. Dr. Harper has also been a paid speaker and consultant for Merck.

Dr. Harper's  ties to Merck and Gardasil have not appeared to have affected  her objectivity in regards to the vaccine. While Dr. Harper has said she is convinced HPV vaccines can help prevent cancers in the long-run, she has been critical in the past of Merck's efforts to have Gardasil declared a mandatory vaccine in many states.

Gardasil has been the subject of controversy ever since it was approved in 2006.  Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported.  According to CBS News, Merck is also looking into cases of ALS (Lou Gehrig’s Disease)  reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered.  Right now, that number stands at 32.

In her interview with CBS News, Dr. Harper said that patients should be told that the benefits of Gardasil vaccination may not outweigh its risks, and that protection may not last a lifetime.  She pointed out that  Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year.  

Dr. Harper also told CBS News that she was concerned that Merck's Gardasil marketing campaign might be misleading women into believing they are getting more protection than the vaccine actually affords.  That belief could cause some women to stop receiving cancer screenings after they are vaccinated.  According to Dr. Harper, data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond that point.