The article by Dr Agnes Vitry on July 22 regarding the enthusiastic promotion of Gardasil by the Australian media and politicians highlights issues which have also been of concern in the US.
It is my belief — as someone with many years experience of pharmaceutical marketing, as well as a mother — that the benefits of Gardasil vaccination are being oversold. I am not a radical who is opposed to medications or vaccinations. My daughter was vaccinated with the chicken pox vaccine and my husband with the hepatitis B vaccine before they were “popular” or mandatory.
I believed in their value and safety at the time they came to market and both have proven themselves.
On the other hand, I have a huge problem with Merck’s attempt at making millions off of the HPV vaccine, Gardasil. At first, I did consider the vaccine for my then 13-year-old daughter.
But after researching the issue, and hearing of how Merck was pushing for mandatory vaccination and promoting aggressive direct-to-consumer marketing messages, I thought I’d wait and see.
Knowing the industry as I do, the company’s tactics seemed more of a scheme to make up for the loss of sales from the arthritis drug Vioxx than anything else. I was concerned about the side effects and the long term effects of the vaccine.
In my book, Escape from the Pharma Drug Cartel, I quote from a letter I wrote in 2007 to Governor Perry in Texas about his plans to make vaccination mandatory. An edited extract follows:
Gardasil may well be the huge medical breakthrough it appears to be. But a rush to make it mandatory, less than eight months after FDA approval, could have detrimental consequences.
Among the reasons to move more cautiously:
The history of new drugs and vaccines is that unexpected adverse events might not be detected until after millions of people have used them, and the Food and Drug Administration does a poor job of tracking post-approval effects. Generally, 51% of FDA-Approved drugs have serious adverse effects not detected prior to approval. USA Today reported that last year the pharmaceutical industry “faced the most product liability lawsuits of any other industry”.
Merck’s own Vioxx, a blockbuster painkiller drug, was withdrawn in 2004, five years after it was introduced, after studies revealed significant heart risks. A vaccine made by Wyeth, to prevent a highly contagious rotavirus that can cause severe diarrhea and vomiting in children, was withdrawn in 1999, just over a year after it was approved, because of safety concerns.
So far, every indication is that Gardasil, the world’s first anti-cancer vaccine, has only rare and minor side effects. Clinical trials of more than 11,000 females ages 9 to 26 showed it was 100% effective in preventing cervical cancers linked to two types of human papillomavirus (HPV), a s-xually transmitted disease. These strains cause about 70% of the cervical cancer cases. So it would not eliminate the need for vaccinated women to have regular Pap smears to detect cancerous cells caused by other HPV strains. HPV is also the virus that causes g-nital warts.
No one will know the complete picture until more people are vaccinated over a period of year. At the moment, Gardasil is so new that scientists aren’t sure how long it’s effective for.
Merck also touts that cervical cancer is the second-leading cancer among women around the world. They are right but 80% of cervical cancers occur in third world countries — those that would benefit the most, can’t afford it.
Kimberley Elliott is the author of Escape from the Pharma Drug Cartel (Amazon.com), and was featured in the 21 June edition of the British Medical Journal.