Gardasil Researcher Speaks Out
Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.
Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.
Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.
This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.
Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”
Is the HPV Vaccine Safe?
When Barbara Archiello’s doctor recommended a vaccine to prevent cancer of the cervix, she jumped at the chance.
“I think it’s just a great thing for women to have,” Archiello said.
But the most comprehensive look at the side-effects of since the HPV vaccine was approved in 2006 raises questions about its safety, reports CBS News medical correspondent Dr. Jon LaPook.
In Tuesday’s Journal of the American Medical Association, the CDC reported more than 12,000 side effects after 23 million doses were distributed. Ninety-four percent of the problems were not serious but 6 percent were, including patients who were hospitalized, permanently disabled or died. There were 32 deaths – one in over 700,000 doses.
“It really isn’t an increase with what we’ve seen with other vaccines and what is seen regularly with people of that age group,” said Dr. Barbara Slade, with the CDC.
But problems that did occur more frequently than expected were fainting – about once every 12,000 doses, and blood clots, once every 500,000 doses.
“The reporting on blood clots was concerning to CDC, concerning in the way that we think it needs further investigation,” Slade said.
Critics question the vaccine maker’s aggressive ad campaign, because it paid medical societies to help spread the word, and underplayed the importance of evaluating the vaccine’s risks and benefits.
“It screeched the message, ‘all women are at equal risk, protect yourself from cervical cancer, and this is the way to do it,'” said Dr. Sheila Rothman, author of the JAMA article. “The fact that the medical societies repeated this message is what concerns us.
New Worries About Gardasil Safety
The National Vaccine Information Center, a private vaccine-safety group, compared Gardasil adverse events to another vaccine, one also given to young people, but for meningitis. Gardasil had three times the number of Emergency Room visits – more than 5,000. Reports of side effects were up to 30 times higher with Gardasil.
“If I’d have known, we never would have gotten the shot,” said Emily Tarsell, whose daughter, Chris, died three weeks after her third Gardasil shot. She was one of the 29 fatalities reported in two years. “And she’d be here to hug.”
Barbara Loe Fisher, co-founder of the NVIC, said: “Now we know from this report that there are more reactions and deaths associated with Gardasil than with another vaccine given in the same age group. It’s irresponsible not to take action.”