Saturday, October 10, 2009

Dr. Diane Harper Badly Misquoted on Gardasil and Cervarix

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I’m not a regular reader of the Guardian’s “woo-medicine”-debunking columnist Ben Goldacre, and when I do read him I often disagree with him.

But he hit a home run with his latest Bad Science column.

He took apart a front page Sunday Express article that has already been widely disseminated around scare sites on the Internet. Of course, you can’t read it on the Sunday Express site anymore because it's been removed. Probably because Dr Diane Harper, who was quoted as saying that HPV vaccines are more dangerous than cervical cancer, is about to sue the pin-striped pants off the always-lurid Express. Or so I hope.

I’ve often felt sorry for Dr Harper. She seems like a forthright, intelligent scientist who removes herself from Merck’s marketing hysteria to make sensible cautionary comments about the Gardasil vaccine, which she has worked on and in general supports. But her comments are frequently taken out of context and paraded around the web as if she were an anti-vaccine crusader.

As someone who is wary of Gardasil to the point of thus far turning it down for my daughters, who have a family history of autoimmune disease; as someone who would like to see an awful lot of very serious questions about Gardasil taken very seriously and answered very seriously, it makes me LIVID. We need more people in the pharmaceutical industry to encourage scientists, physicians and the public to ask intelligent questions and not simply swallow the party line wholesale. So-called reporters like the notorious Express’s Lucy Johnston badly undermine the likelihood of that happening.

If I’ve understood Dr. Harper correctly—forgive me if I haven’t, Dr. Harper, and feel free to correct me—she thinks that HPV vaccines are in general a good thing but that Gardasil should have been introduced more slowly and cautiously; and that perhaps people with family histories of auto-immune disorders should be particularly cautious. She thinks—again, if I understand correctly—that Merck’s unprecedented intensive marketing campaign has oversold Gardasil; that the 3-shot series and its marketing might make women cavalier about still-essential annual exams; that we don’t know how long protection will last.

According to Goldacre, what she doesn’t think is what she was reported as saying in the Express’s article. That the cervical cancer vaccine 'may be riskier and more deadly than the cancer it is designed to prevent.' That the jab 'would do nothing to reduce the rates of cervical cancer in the UK.' Etc., etc., etc.
Goldacre simply contacted Harper directly when he read the article.

“I will explain Harper's position in her own words,” he writes. “They are unambiguous: ‘I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a 'controversial drug'. I did not 'hit out' – I was contacted by the press for facts. And this was not an exclusive interview.”

Harper did not "develop Cervarix" but she did work on some important trials of Gardasil and also Cervarix. "Gardasil is not a 'sister vaccine' as the Express said, it is a different compound. I do not know of the side effects of Cervarix as it is not available in the US.’

“She did not say that Cervarix was being overmarketed. ‘I did say that Merck was egregiously overmarketing Gardasil in the US – but Gardasil and Cervarix are not the same vaccines’…She also suspects from modelling data that for the specific and restricted group of women who are punctilious about attending every single one of their cervical cancer screening appointments, vaccination may have little impact on their risk of death from cancer; but even they will benefit from the reduction in reproductive problems caused by treating pre-cancerous changes in cervical cells.

‘I fully support the HPV vaccines," she says. "I believe that in general they are safe in most women. I told the Express all of this.’”

That was a lot of Goldacre’s column to reproduce. But I think it bears repeating as long as the Sunday Express article inevitably circulates and spawns more mis-information.

2 comments:

Vaccination Awareness said...

Actually the CBS August 2009 article where Diane said similar things remains, also:

http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt

Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.

Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.

http://www.vaccinationawarenesscampaign.co.uk/

bonnie555 said...

Dr. Harper has been victim of a relentless campaign attempting to discredit the validity of her claims. Harper was even misquoted by British tabloid The Sunday Express which printed a false story loaded with fabricated quotations attributed to Harper. In an interview with The Guardian, Harper makes it very clear about what exactly she said in order to protect herself from a potential lawsuit. In an interview with CBS NEWS, Harper clarifies her position, and once again makes it crystal clear just how devastating this vaccine can be: “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.

“The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s Dr. Barbara Slade) were 3.4/100,000 doses distributed,” Harper tells CBS NEWS. ”The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade’s article, as they are based on a denominator of doses distributed from Merck’s warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade’s work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information,” said Harper.

“Parents and women must know that deaths occurred,” Harper tells CBS NEWS. “Not all deaths that have been reported were represented in Dr. Slade’s work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil.” She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. “The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers — something never stated, but often inferred by many in the population — a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably.” Harper notes that her concern for the vaccine’s deadly side effects applies only to women in the Western world. ”Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”