To the surprise of just about everyone, the March 2007 federal budget included a provision to provide $300 million to the provinces to distribute, on a per capita basis, a vaccine for HPV (Human Papillomavirus), called Gardasil, manufactured by the US drug company Merck Frosst. The drug has been loudly touted by the manufacturers as having the potential to eradicate cervical cancer.
The use of this drug, however, has raised many unanswered questions about its safety and effectiveness. Unfortunately, these concerns have been drowned out by backroom lobbying and a massive marketing campaign on behalf of Gardasil by its manufacturers. They are trying to get their drug accepted before their rival, GlaxoSmithKline, completes its clinical trials on its own cervical cancer vaccine, Cervarix.
Politicians as well as organizations have also been heavily pushing the drug. In March, 2007, the Liberal dominated House of Commons Finance Committee recommended that the vaccine be distributed as a national priority. The Federation of Medical Women (which, by the way, receives funding from Merck Frosst) is also promoting the drug, as is the feminist, pro-abortion Society of Obstetricians and Gynecologists, and the National Advisory on Immunization.
The Story Behind the Push for Gardasil
Health Canada approved Gardasil in July, 2006. The federal, provincial, and territorial body, called the Canadian Immunization Committee, then set to work to determine whether the drug was effective and cost efficient for distribution in school-based immunization programmes.
However, the Committee’s work was short-circuited by the Minister of Finance Jim Flaherty’s announcement of his $300 million kick-start on promotion of the drug. The federal interest in providing this drug is due to the advocacy of a lobbyist, who had previously been an advisor to Prime Minister Harper when he was the opposition leader, but who is now a lobbyist for Merck Frosst.
The provinces were thrilled by the money offer, but public health officials were concerned by the break-neck speed at which this drug was being offered without proper scientific, pharmacological and economic research. Also, all the clinical trials on the drug have been carried out solely by the manufacturer on only 1,200 girls in the targeted group of 9 – 15 year olds. As well, these latter trials have been monitored only for a mere 18 months.
Doubts About the Drug
The Canadian Medical Association Journal, in its August 28, 2007 issue, raised concerns about the safety, effectiveness and cost of the drug, which is the most expensive childhood vaccine proposed for mass use. (It costs $404 for the three required doses.) The Journal stated that the use of the drug raises more questions than answers and that the information base on the drug is, at present, too narrow to merit a policy of mass vaccination.
REAL Women is also concerned about the politically driven advocacy of this drug, and on July 5, 2007, wrote to each of the provincial and territorial Ministers of Health to request that the distribution of the drug be delayed until such time as its effectiveness and safety are confirmed. In our letter, we set out our concerns, as follows:
There are only limited data on the effects of the drug on pre-teen and early teen-age girls. The drug has been tested on fewer than 1,200 girls, ages 9 to 15 years, and the research has been done almost exclusively on young women 16 to 23 years of age. This raises questions about the drug’s efficacy, safety, and long-term effects. It would appear that any young girl, to whom Gardasil is to be administered, will be the unwitting subject of a massive research experiment.
There is uncertainty as to the length of time the vaccine will provide protection; as well, if and when booster shots will be required. What is known is that Gardasil is a prophylactic vaccine that targets the viruses that lead to cancer, rather than cancer itself, and that cervical cancer is a slow developing disease. Cancer data show that the average cervical cancer patient is 47 years of age and that HPV incubates for up to 15 years before becoming cancerous. That is, the virus manifests itself when the woman is in her thirties – decades after young girls may have been administered the vaccine. There are no data available as to the actual effectiveness of this drug over this long intervening period of time.
There are more than 100 types of HPV, about 40 of which can cause cancer – but the HPV vaccine protects against only 4.
There are known side effects to Gardasil, mostly neurological symptoms, which include severe headaches, dizziness, temporary loss of vision, slurred speech, fainting (seizures), joint pain, muscle weakness, and involuntary contraction of the limbs.
In the United States, the Vaccine Adverse Event Reporting System (VAERS) has reported 1,261 such incidents. Several deaths have also been reported. Moreover, the long term neurological or immune system complications caused by the drug are completely unknown. It is uncertain if any of those vaccinated will go on to develop fertility problems, cancer, or genetic damage: the drug manufacturer, Merck Frosst, admits, in its product insert, that these possibilities have not been studied.
According to Statistics Canada, there are approximately 400 deaths a year in Canada caused by cervical cancer, whereas there are 5,400 deaths from breast cancer. The cause(s) of breast cancer are not yet known. It is known, however, that HPV is contracted only through sexual activity and is the most common sexually transmitted disease. Most HPVs are harmless, while others are self-limited infections, i.e., they typically disappear within two years, and most infected individuals do not even realize they have the virus.
Provinces Quick to Take the Money Offer
Some provinces, however, despite the major concerns expressed by REAL Women and others, found the cash offered by the federal government too hard to pass up – especially since this cash may not be available three years from now when the federal money runs out. Also, the provinces are not immune to the fact that they will gain political points with the public by distributing the drug. The public demand for this drug has been created by the media mindlessly and uncritically parroting the claims of the manufacturers in their hard driving marketing campaign. According to Anne Rochon, Federal Co-Ordinator of Women and Health Protection, which is a coalition of community groups, unions, researchers, journalists and activists concerned about the safety of pharmaceutical drugs:
What has happened here is a milking of public sentiment around the fear of cancer; and politicians, along with some other well-meaning people have bought into it. Consequently, thousands of young Canadian girls will be administered, at great expense, a questionable drug and in doing so, will be the subject of a massive research experiment on behalf of the manufacturer.
At the time of writing, the decisions of the provinces concerning their participation in the distribution of the drug Gardasil, were as follows:
| Newfoundland and Labrador |
Fall 2007; Grade 6 (2,800 girls); $1.5 million a year |
| Prince Edward Island |
Fall 2007; Grade 6 |
| New Brunswick |
No Decision |
| Nova Scotia |
Fall, 2007; Grade 7 (6,000 girls) |
| Quebec |
No Decision |
| Ontario |
Fall 2007; Grade 8 (84,000 girls) no catch-up; $39 million a year |
| Manitoba |
No Decision |
| Saskatchewan |
No Decision |
| Alberta |
No Decision |
| British Columbia |
Fall 2008; and catch-up in Grade 9 for the next three years (50,000 girls); $18 million a year |
| Yukon |
No Decision |
| Northwest Territories |
No Decision |
| Nunavut |
No Decision |
The tragedy is that pap smears still remain the best tool available for preventing cervical cancer. If all women received a regular pap smear, cervical cancer would be virtually eliminated. Unfortunately, marginalized women, such as those who are poor, immigrant or of minority status, as well as others who lack access to health care programs that include pap smears, are greatly disadvantaged. It is they who should be targeted, not pre-pubescent girls. |
