Merck’s great big public health experiment
Dr. Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine, who says, “giving the drug to 11-year-old girls is a great big public health experiment.”
Alliance for Human Research Protection AHRP‘s stated rationale for objecting to a policy mandating Merck’s HPV vaccine in 11 year old girls is validated by an internationally recognized expert in the field who tested the vaccine in clinical trials.
Dr. Harper, a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, said: “It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue.”
All of her trials have been with subjects ages 15 to 25.
“This vaccine has not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer – they won’t know for 25 years if they will get cervical cancer.”
Dr. Harper said, Merck was required to put together a database on the efficacy in children before Gardasil was approved. But instead, the company put together four study sites that “are not necessarily representative, and may not even have enough numbers to determine what they need to know.”
She believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up. At the time of their first inoculation, they should be tested for the presence of HPV in their system. If the test comes back negative, then schedule the follow-up series of the three-part shots.
But if it comes back positive?
“Then we don’t know squat, because medically we don’t know how to respond to that,” Harper said.
She said that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most – meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won’t work at all if she was positive for the virus when she was inoculated in the first place.
Merck knows this, Harper said. “To mandate now is simply to Merck’s benefit, and only to Merck’s benefit,” she said.
Dr. Harper said, she’s been trying for months to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine. “But no one will print it,” she said.
Something is very wrong with this commercially driven frenzied marketing which all those who shape public policy and public opinion were caught shilling for Merck.
Independent advocates need to take to the streets to protect our children from irresponsible pharmaceutical companies whose financial largesse buys public officials, government agencies that are supposed to protect us from potentially harmful drugs and vaccines, and the uncritical transcribers of hype in the press.
This article was written by Vera Hassner Sharav (212-595-8974) for the Alliance for Human Research Protection- AHRP Website. AHRP is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to ensure that the human rights, dignity and welfare of human subjects are protected, and to minimize the risks associated with such endeavors.
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