Post by Icarus on Feb 10, 2007 15:01:40 GMT -5
blogs.usatoday.com/oped/2007/02/post_19.html#more
Our view on public health: Rush to require cancer shot threatens to promote backlash
HPV vaccine holds great promise, but Texas mandate is premature.
Thanks to vaccines, devastating diseases such as smallpox and polio have been virtually eradicated in the USA. That wouldn't have happened if states hadn't required immunizations for serious contagious viruses before a child can attend school.
Now there's a new vaccine, one with potential to prevent cervical cancers that kill 3,700 women each year in the USA and 300,000 worldwide. Called Gardasil, it is manufactured by Merck & Co. and was approved in June by the U.S. Food and Drug Administration.
Texas Gov. Rick Perry is so enthusiastic about Gardasil that a week ago, he ordered all girls in the state to be immunized before entering sixth grade, as of September 2008. (Parents can opt out for religious and other reasons.) Prompted in part by a vigorous lobbying campaign by Merck, which stands to earn billions of dollars if the vaccine is required, legislators in 23 other states and the District of Columbia have proposed mandating vaccination against HPV for girls as young as 11.
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 deliberately:
Scientific uncertainty.
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 FDA does a poor job of tracking post-approval effects.
Merck's Vioxx, a blockbuster painkiller drug, was withdrawn in 2004, five years after it was introduced, after studies revealed significant heart risks.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made by Wyeth, to prevent a highly contagious rotavirus that can cause severe diarrhea and vomiting in children, was withdrawn in 1999, just over a year after it was approved, because of safety concerns.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 sexually transmitted disease. But no one will know the complete picture until more people are vaccinated for more time. At the moment, Gardasil is so new that scientists aren't sure how long it's effective for.
Public unawareness.
Little public education about the HPV vaccine has occurred. Support appears strong, but 25% of parents in a recent California study expressed reservations. Mandating Gardasil now could spark an anti-vaccine backlash that would result in fewer girls getting immunized against cervical cancer and other diseases. Perry's executive order short-circuited a legislative debate that could have convinced many Texans of the vaccine's merits.
Nature of the disease.
HPV is spread only by intimate sexual contact. It isn't in the same class of contagious diseases such as measles, mumps and diphtheria that can spread easily to children in the classroom. Because some parents are uneasy about vaccinating pre-teens for a sexually transmitted disease, the issues need to be handled delicately.
With more public education and real-life experience, these qualms may soon be overcome and the vaccine may well deserve to be included on lists of required immunizations.
For now, however, making it mandatory is premature. The vaccine ought to be available, at an affordable price, to everyone who wants it after consulting with a doctor. But sometimes, promotion of a medical advance can move too fast for its own good.
Our view on public health: Rush to require cancer shot threatens to promote backlash
HPV vaccine holds great promise, but Texas mandate is premature.
Thanks to vaccines, devastating diseases such as smallpox and polio have been virtually eradicated in the USA. That wouldn't have happened if states hadn't required immunizations for serious contagious viruses before a child can attend school.
Now there's a new vaccine, one with potential to prevent cervical cancers that kill 3,700 women each year in the USA and 300,000 worldwide. Called Gardasil, it is manufactured by Merck & Co. and was approved in June by the U.S. Food and Drug Administration.
Texas Gov. Rick Perry is so enthusiastic about Gardasil that a week ago, he ordered all girls in the state to be immunized before entering sixth grade, as of September 2008. (Parents can opt out for religious and other reasons.) Prompted in part by a vigorous lobbying campaign by Merck, which stands to earn billions of dollars if the vaccine is required, legislators in 23 other states and the District of Columbia have proposed mandating vaccination against HPV for girls as young as 11.
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 deliberately:
Scientific uncertainty.
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 FDA does a poor job of tracking post-approval effects.
Merck's 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 sexually transmitted disease. But no one will know the complete picture until more people are vaccinated for more time. At the moment, Gardasil is so new that scientists aren't sure how long it's effective for.
Public unawareness.
Little public education about the HPV vaccine has occurred. Support appears strong, but 25% of parents in a recent California study expressed reservations. Mandating Gardasil now could spark an anti-vaccine backlash that would result in fewer girls getting immunized against cervical cancer and other diseases. Perry's executive order short-circuited a legislative debate that could have convinced many Texans of the vaccine's merits.
Nature of the disease.
HPV is spread only by intimate sexual contact. It isn't in the same class of contagious diseases such as measles, mumps and diphtheria that can spread easily to children in the classroom. Because some parents are uneasy about vaccinating pre-teens for a sexually transmitted disease, the issues need to be handled delicately.
With more public education and real-life experience, these qualms may soon be overcome and the vaccine may well deserve to be included on lists of required immunizations.
For now, however, making it mandatory is premature. The vaccine ought to be available, at an affordable price, to everyone who wants it after consulting with a doctor. But sometimes, promotion of a medical advance can move too fast for its own good.
