Healthy Skepticism Library item: 11065

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Publication type: news

Laucius J.
Journal raises flag over cervical cancer drug
The Ottawa Citizen 2007 Aug 2
http://www.canada.com/ottawacitizen/news/story.html?id=220263c9-b4e7-4497-bfe3-edc9fd9ceed9&p=1

Full text:

More research needed before widespread vaccinations: author

It’s too early for Canada to immunize all girls and women against a virus that causes cervical cancer, says a bombshell article published yesterday in the electronic edition of the Canadian Medical Association Journal.

Last month, Nova Scotia became the first and only province to outline a plan to roll out the Gardasil vaccine under a $300-million national program announced in the last federal budget.

The vaccine, administered in three doses over six months, prevents the spread of human papillomavirus (HPV), a sexually-transmitted virus that causes most cervical cancers. Nova Scotia will offer it to 6,000 Grade 7 girls starting this fall.

However, there are many questions left unanswered, says the article, published yesterday in advance of the journal’s Aug. 28 paper edition.

Lead author Abby Lippman said yesterday she was surprised when the vaccine funding was announced in the federal budget. The money could be better used to figure out if the vaccine is the best way to prevent cervical cancer, she said.

“Take a deep breath. We don’t have a crisis or an epidemic. We have a golden opportunity to do things the right way,” said Ms. Lippman, chairwoman of the Canadian Women’s Health Network board and a professor in the department of epidemiology, biostatistics and occupational health at McGill University.

Gardasil has been marketed as the solution to almost eradicate cervical cancer. But Ms. Lippman’s paper questions whether the vaccine could fulfill that promise, and even whether there could be unintended negative consequences.

About 1,400 Canadian women are diagnosed with cervical cancer and 400 women die each year. But invasive cervical cancer develops slowly and if caught early enough with regular Pap tests, it can be treated, said Ms. Lippman.

Of the 100-plus strains of HPV, about 15 have been identified as high risk. The Gardasil vaccine protects against two of these strains. Although anywhere between about 10 and 30 per cent of the population has had one of the strains of HPV, most healthy women will clear an HPV infection from their bodies. Even without any treatment at all, HPV disappears about 90 per cent of the time, she said. And the prevalence of the two Gardasil strains is relatively low.

Ms. Lippman’s article points out that clinical trials involved 20,000 girls and women, but less than 1,200 of them were between the ages of nine and 15 — the target group for universal vaccinations.

At the same time, it’s hard to say how long the vaccine will be effective. The longest follow-up reported so far has been only 60 months, and only 241 individuals were followed. It is still unknown if girls who get the vaccine will need boosters, for example.

The vaccine may also create a false sense of security, says Ms. Lippman, who fears that women have been vaccinated will be less vigilant about safe sex and regular Pap tests.

Even vaccinated women still need to continue taking Pap tests, said Ms. Lippman, who suggests that perhaps investing in ensuring that all women have regular access to Pap tests could be a more effective and less expensive way to reduce cervical cancer deaths. Other vaccines are still in development that may cover a greater number of the HPV viruses.

The issues are so complicated that family physicians don’t have the time to go into all the issues with patients, she said. As well, the cost of vaccine — between about $400 and $600 per patient — is “exorbitant.”

Meanwhile, the $300 million in federal money is only a small part of what it would cost to vaccinate all of Canada’s eligible girls and women. That figure is estimated at between $2 billion and $3 billion, she said.

A background paper written by economist and epidemiologist Hans Krueger of the British Columbia Cancer Agency, for example, estimated that introducing the vaccine in B.C. would save $54 million at a cost of about $373.6 million, assuming a cost of $330 for the vaccine and $100 for a booster.

Jean Riverin, a spokesman for the Public Health Agency of Canada, said the National Advisory Council on Immunization recommended the vaccine last February.

The agency is aware of some of the questions around Gardasil, including the possible need for booster shots, he said. Immunizing girls and young women will buy two or three years until more is known, he said.

“Are we going to say ‘no’ and not immunize these young women at risk? Don’t we have the responsibility to protect right away when the technology is there?”

Ms. Lippman says she doesn’t know all the answers. “I’m just throwing out endless questions,” she said.

“I don’t want people to die. But it’s not an epidemic. This is an expensive way to reduce the anxiety.”