Posted on 04/10/2005 5:27:42 AM PDT by jalisco555
At first blush, a vaccine that prevents a deadly form of cancer would seem like a no-brainer for parents.
But as two major drug makers prepare to introduce such a product, sides are already being drawn in what promises to be an all-out culture clash.
Within two years, Merck and GlaxoSmithKline hope to market a pair of groundbreaking vaccines to prevent a sexually transmitted disease. Known as the human papillomavirus, or HPV, the disease is a leading cause of cervical cancer. About 5,000 women in the United States die each year from cervical cancer.
One drug maker, Merck & Co. Inc., says it will try to persuade states to require vaccination of children as young as 12 before they're allowed to start the next year of school.
"The best way to prevent infection is to vaccinate the population just before they become sexually active, which is when they're young," said Eliav Barr, Merck's senior director of biologics clinical research. "This way, it can be folded into routine medical care."
But the rollout of the vaccines promises to be anything but routine. Vaccinating children for a disease caused by sexual activity may be a tough sell, especially among parents who fear children will take it as a green light to have sex.
Public health officials and parents are gearing up for a heated debate about the finer points of cancer prevention, health care costs and teenage sex.
"The best way to prevent HPV is through abstinence," said Bridget Maher, an analyst at the Family Research Council, a conservative group that expects to campaign against making the vaccines mandatory for entering school. "I see potential harm in giving this vaccine to young women."
A Merck study of 2,053 parents released last year found 11 percent of those with 13-year-old girls probably or definitely wouldn't want them vaccinated before their 18th birthday. Another 27 percent were undecided.
A separate study last year in the Journal of Lower Genital Tract Disease found 24 percent of 575 parents opposed a vaccine and believed it would lead children to engage in sexual activity sooner than they would otherwise.
The studies found most parents support vaccinating their children. The results also indicate some parents become supportive after learning about the health benefits or hearing doctors recommend vaccination.
HPV can be transmitted through other forms of sexual contact in addition to intercourse. As parents inclined to oppose vaccination learn this, they may become more supportive, according to a study in the American Journal of Epidemiology.
"This will be an arduous educational mission," said Daron Ferris, a professor of family medicine and obstetrics/gynecology at the Medical College of Georgia who ran trials for the Merck vaccine. "But once they realize we have a vaccine to prevent cancer, I'd expect parents will want to protect their loved ones."
Unlike Glaxo, Merck will also target genital warts with its vaccine. Doctors caution this may fuel more controversy if teenagers see a vaccine as an easy way to combat yet another increasingly common sexually transmitted disease.
Some experts who see trouble ahead cite the heated battle concerning an over-the-counter morning-after pill recommended for girls as young as 16 by a federal panel in 2003. Anti-abortion groups opposed the contraceptive pill, and the Food and Drug Administration still hasn't approved it.
"Sex is a scary thing in this culture, and the age of the girls to be vaccinated will really be an issue," said Janice Irvine, a University of Massachusetts sociology professor and author of "Talk About Sex," a book on sex education. "You can expect opposition to this vaccine."
These predictions worry the drug makers. As some best-selling drugs face competition from cheap generic rivals, vaccines will become a source of much-needed revenue. This is especially true for Merck. The drug maker, based in Whitehouse Station, N.J., loses patent protection next year on its cash cow, the Zocor cholesterol pill.
As Wall Street sees it, an HPV vaccine holds tremendous promise.
The global market could hit $4.3 billion in revenue by 2010, according to a recent report by Richard Evans, an analyst at New York-based Sanford C. Bernstein and Co., an investment research and management firm. His projection anticipates adolescent girls and boys, as well as women in their 20s and 30s, will be vaccinated.
The heady forecasts stem from data showing cervical cancer is widespread: About 500,000 women worldwide are diagnosed each year, leading to 230,000 deaths, according to the World Health Organization. In the United States, about 15,000 women are diagnosed annually.
For the companies to realize those billions of dollars in annual revenue, they are expected to advertise widely and charge a lot, Evans said. Merck will likely charge $100 for each of three needed doses, he said, while Glaxo may charge $80 per dose.
At those prices, an HPV vaccine would cost more than other childhood vaccines, according to an article in the journal Clinical Infectious Diseases written by officials at the federal government's Centers for Disease Control and Prevention. An average dose of vaccine for measles, mumps and rubella cost $34.73 in 2003, while a dose of chickenpox vaccine was $58.11.
The HPV vaccines would be "fairly expensive for this country," said Lauri Markowitz, the Atlanta-based agency's chief of epidemiology research in prevention of sexually transmitted diseases. But Markowitz said if a vaccine is shown to be safe and effective against HPV, the agency believes it would help prevent cervical cancer.
An official endorsement from the Centers for Disease Control and Prevention would not only influence doctors to recommend vaccination, but would spur health plans to cover the cost.
The drug makers are unwilling to discuss prices, but note that diagnosing and treating HPV is expensive. Related health costs were estimated to be at least $1.6 billion annually, according to a 1999 federal study. The costs include doctor visits, Pap tests to detect cervical cancer and follow-up procedures.
"A vaccine would be a more efficient use of health care dollars," said Evan Myers, an associate professor of obstetrics and gynecology at Duke University and a consultant to Merck who has studied the economic impact of an HPV vaccine.
The best way to maximize savings, the companies maintain, is to vaccinate children as young as possible. London-based GlaxoSmithKline plc plans to push for vaccinating girls as young as 10, according to David Pernock, senior vice president for pharmaceuticals and vaccines.
"Anyone who thinks a lot of teenagers aren't sexually active has their head in the sand," said Cody Meissner, a pediatrics professor at Tufts-New England Medical Center in Boston and vice chair of the American Academy of Pediatrics' infectious disease committee.
"No one's pleased about that, but it's a fact of life," Meissner said. "If the results of the final-stage clinical trials for these vaccines are consistent with what's known so far, they will be a wonderful contribution to public health."
But convincing doctors may prove easier than persuading state officials to require vaccination, as Merck intends to do.
"I don't think we'd require the schools to mandate something like this," said Eddy Bresnitz, deputy commissioner of New Jersey's Department of Health and Senior Services. "I'm sure the battle will be huge, and I'm not sure it's a battle we should be fighting."
(Ed Silverman covers the pharmaceutical industry for The Star-Ledger of Newark, N.J. He can be contacted at esilverman@starledger.com
well, one woman already decided that for her husband (Bobbitt) so watch out! ;-)
While there are around 100 different HPV types that infect humans only around 13 or so involve the female genital tract. The rest cause plantar warts and the like. Of the 13 cancer causing types two of them - types 16 and 18 - cause around 2/3 of all cervical cancers. None of the vaccines currently being tested are active against all 13 types but only the most common ones.
As to the commonness of HPV, well over half of all reproductive age women are infected at one time or another, although most will clear the infection spontaneously.
I do not see any need to make this vaccination mandatory or a school admission requirement. I would definitely talk to my daughter with her doctor to see if this was a vaccine she would want. Thankfully, I have at least 12 years before that, and I am sure she will not be sexually active for another 12-15 years after that! ;)
By the way, was chicken pox really that bad that we need a vaccine to prevent kids from getting it? Just wondering, I remember when my sisters and I all got them. It didn't seem a big deal. My kids get all vaccinations but prevnar and I am thankful that the pediarix came out to combine some of the shots. My 5 month old has been getting that one and has had no reactions or even the slightest bad time with it.
While chicken pox isn't too serious in kids it can be very serious if it infects adults and not everyone gets it as a kid. That's the main reason for vaccination.
Do not think that Hepatitis B can only be contracted by sexual activity or intravenous drug abuse/needle stick alone. The Hepatitis B virus can be contracted by any exposure to bodily fluids. Hepatitis B is extremely common in Southeast Asia. And especially common in Americans of Southeast Asian Americans. Many very young children within these households are tested positive for Hepatitis B exposure without ever having any history of sexual exposure or intra-utero exposure during birth. While cervical cancer is entirely a sexually transimitted disease due to HPV, it is not as common as Hepatitis B and not so easily transmitted as Hep. B.
My oldest will get one when he turns 4 in August. He was supposed to get it sooner but I was pregnant twice and he couldn't. I remember teaching preschool in 1994-5 and one of the moms gave us instructions that if any kids got chicken pox, her son was to go and hold the child and try to get it. She needed a week off from work and he never got them as far as I knew. LOL!
Vaccinations can help to eradicate diseases entirely.
For a gripping read that will really educate on how that's done, find yourself a copy of "The Demon in the Freezer". It's about the eradication of smallpox, and the threat of bio-terror with smallpox and anthrax. EVERYBODY should ead ths book! (It's also quite enjoyable ... even if quite disturbing.)
If the vaccine has no side effects then I would be first in line to have my daughter protected. I can't imagine anyone taking the chance of their child getting cervical cancer when there is a way to avoid it.
By the way, was chicken pox really that bad that we need a vaccine to prevent kids from getting it?
My understanding is that once a person contacts chicken pox, the virus stays in their bodies forever and can later emerge as shingles. And that people who have an active case of shingles are contagious & spread chicken pox to those who aren't immune.
NOOOOO!!!!!
Hasn't been studied yet, as far as I know. It's not clear how one could determine the efficacy of a vaccine in men. The studies done on women look at the rate of precancerous changes in vaccinated women versus controls (not, by and large, at antibody levels). Men aren't affected by the virus the way women are so I'm not sure how you could design a study.
I am as well. My mother is a paraplegic as a result of having contracted the polio virus at age four (before the development of the vaccine). I think sometimes we take for granted that most serious childhood diseases have been virtually eradicated as a reault of widespread vaccination.
reault=result
Free market bump
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