AND NOW FOR SOMETHING COMPLETELY DIFFERENT, A VACCINE INSIDER DECIDES TO SPEAK THE TRUTH

Like many people, I have been following with interest the continuing story about the introduction of the Garadasil vaccine. Gardasil is a vaccine designed to prevent some strains of the humanpapilloma virus (“HPV”), which some scientists say may contribute to the development of cervical cancer. Although I have been aghast at the marketing of the vaccine as a cancer preventative (I guess it’s much easier to sell to the public than calling it a vaccine for viruses that are most commonly spread through unprotected sex), I have not weighed in on the debate until now.

First, the debate doesn’t directly address the issue of autism causation, although any part of the vaccine program is related to some extent. Primarily, though, I was a little timid about being labeled an “anti-vaxer” (not that there’s anything wrong with that) simply because I would like to see a little sanity ⎯ some sense, if you will ⎯ “injected” into the way we vaccinate our children.

Now it seems that my concerns are shared not just by a bunch of crazy parents, but also by a staunch proponent of the vaccine program ⎯ someone who helped in the development of Gardasil and who believes it to be a “good” vaccine that “will save a huge number of lives around the world.”

The story comes courtesy of Kim Stagliano’s blog. Kim posted the complete article, which appeared in an Indiana paper because she correctly assumed that the media would, by and large, ignore the issue. Indeed, only a handful of local outlets are showing any interest at all.

Dr. Diane M. Harper, the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School, calls it “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.” Instead, Dr. Harper believes that “the ideal way of administering the new vaccine is to offer it to women ages 18 and up.”

This is a scientist who has devoted her life to studying the more than 100 strains of HPV. Much of her recent work for vaccine study has been funded through Dartmouth in part by both Merck & Co. and GlaxoSmithKline. Merck, of course, is the manufacturer of Garadasil, which reportedly protects against four strains of HPV, two of which are considered to be cancer-causing viruses. Glaxo’s vaccine, Cervarix, which targets the two cancer-causing strains, is expected to be on the market by 2008.

As the director of an international clinical trial for these vaccines, and as author of lead articles about the vaccines’ effectiveness, Harper has been quoted widely as saying this vaccine could have enormous potential to eradicate the great majority of cervical cancers.

Picking up on this, but before the trials were even completed, major news media and women's advocacy groups began trumpeting the vaccine as an answer to cancer of the cervix. Once it was approved by the FDA and ACIP, Women In Government (WIG), a non-profit organization comprised of female state and federal legislators, began championing Merck’s vaccine in their home states, with many of the ladies introducing legislation that would mandate the vaccine for 11- and 12-year-olds.

Dr. Harper’s criticism is based on solid ethical and pragmatic principles that even the most ardent supporters of vaccines would have difficulty refuting:

“This vaccine should not be mandated for 11-year-old girls,” she reiterated. “It’s 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.

“Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer.”

The reason, she said, is because the vaccine does not protect against all HPV viruses that cause cancer ⎯ it’s only effective against two that cause about 70 percent of cervical cancers. For months, Harper said, she’s been trying 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.

It’s easy to speculate as to the reasons the media seems disinclined to trumpet this tale. First, the news organizations were so quick to jump on the “medical miracle” bandwagon after Garadsil’s release was announced that they may be a bit reluctant to admit that they so easily fall victim to aggressive marketing. Moreover, it’s no secret that Merck and Glaxo are major sources of revenue for various media outlets. One only has to open a newspaper or magazine, or turn on the television news, to confirm that.

And make no mistake about it. The push by many states to mandate adding Gardasil to official vaccine schedules bears the company’s fingerprints:

. . . “To mandate now is simply to Merck’s benefit, and only to Merck’s benefit,” she said. Merck was required to put together a database on the efficacy in children before Gardasil was approved, Harper said. 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.”

Since she doesn’t personally have access to the money Merck and GlaxoSmithKline pay for her HPV vaccine research, Harper doesn’t know exactly how much either has paid Dartmouth for her work. The trials are expensive, between $4,000 and $5,000 for each patient, she said. With over 100 patients in her study, some big bucks could be in the balance, should Merck or Glaxo become upset with her for making these comments. Why, then, would she risk speaking out like this ⎯ at a time when her words very well could influence legislation across the country, and prompt legislators to drop the mandates? Isn’t she afraid of losing her funding?

“I want to be able to sleep with myself when I go to bed at night,” Harper said. “My concern is still, let’s get women’s health better. It is still a good vaccine. But let’s be honest. Don’t over-promise.”

I hope Dr. Haper has tenure.

Go to Kim Stagliano’s blog here to read the whole story, including Dr. Harper’s opinions on the good and not-so-good about Gardasil.