If you're getting together with family this holiday season, you might want to spend some time talking about your medical history. Experts say by looking into your past, you might learn something about the risks you face in the future. If you do have that conversation with your family, be sure to talk to everyone. Your risks of certain cancers might come from some pretty unlikely people.
Even if it's just helping her dad do chores around the house, Janel Hall knows the importance of spending time with family. Janel has watched a grandmother and four aunts battle cancer. So when doctors told her she was almost certain to get it, she considered some dramatic steps to avoid it.
"We looked at all the options. One of the options was a complete hysterectomy and, of course, a complete mastectomy," says Janel.
That may seem drastic, but genetic tests show that Janel's odds of getting ovarian cancer are nearly 50% and her odds of getting breast cancer are nearly 90%. Given her family history, that didn't surprise Janel. What did surprise her is that it was her father who passed along the risk.
"There's been a big myth that people can't inherit breast or ovarian cancer genes from their father. And unfortunately, that's just not true," says Heather Hampel, a genetics counselor at Ohio State University's James Cancer Hospital.
Hampel says ovarian and breast cancer can be treated effectively if they are caught early. The best way to do that is to know your family history. But many women assume that those types of cancers can only come from their mother and don't realize they are at risk.
"If you can find out ahead of time that you have an increased risk of cancer, then you can do something about it. And this is a gift that older generations didn't have," says Hampel.
Jane's done something about it. She decided to have a hysterectomy to avoid ovarian cancer and is screened closely every year for breast cancer. Her sister tested negative. Though the test results were mixed, it's given their father some peace of mind.
"I think it's good because now there's less decision making when something shows up. We know that something has to be done, we can't just hope it gets better," says Janel's father, Ron Everson.
What put Janel at such a high risk is that she tested positive for the BRCA-1 and BRCA-2 genes that are linked to cancer. If there is a strong history of cancer in your family, you may want to meet with a genetic counselor like Janel's family did.
osu.edu
четверг, 27 октября 2011 г.
четверг, 20 октября 2011 г.
Romney Criticizes Obama For Support Of Sex Education For All Grades
Former Massachusetts Gov. Mitt Romney, who is running for the Republican presidential nomination, on Thursday criticized Sen. Barack Obama (Ill.), who is running for the Democratic presidential nomination, for supporting a 2003 measure in the Illinois Legislature that would have allowed age-appropriate sex education for children as young as kindergartners, the AP/ABC News reports. Obama in 2003 was a state senator and chair of a committee that approved a bill that would have changed Illinois sex education regulations to include instruction of any grade.
Obama on Tuesday at a Planned Parenthood Action Fund forum said that he considers sex education for kindergartners appropriate if it is tailored to their age level. He has said that if a kindergartner asks a question such as where babies come from, they should be told accurate information. Obama also said warning young people about inappropriate touching is an example of the type of sex education he supports, adding that he was criticized for his position on sex education during his 2004 U.S. Senate campaign as well.
"Sen. Obama is wrong if he thinks science-based sex education has any place in kindergarten," Romney said Thursday during a speech in Sparatansburg, S.C. Romney on Wednesday at a fundraising dinner in Colorado Springs, Colo., said, "How much sex education is appropriate for a five-year-old? In my mind, zero is the right number."
Obama on Thursday said, "We have to deal with a coarsening of the culture and the over-sexualization of our young people," adding, "Of course, part of the coarsening of that culture is when politicians try to demagogue issues to score cheap political points" (Davenport, AP/ABC News, 6/19).
Obama on Tuesday at a Planned Parenthood Action Fund forum said that he considers sex education for kindergartners appropriate if it is tailored to their age level. He has said that if a kindergartner asks a question such as where babies come from, they should be told accurate information. Obama also said warning young people about inappropriate touching is an example of the type of sex education he supports, adding that he was criticized for his position on sex education during his 2004 U.S. Senate campaign as well.
"Sen. Obama is wrong if he thinks science-based sex education has any place in kindergarten," Romney said Thursday during a speech in Sparatansburg, S.C. Romney on Wednesday at a fundraising dinner in Colorado Springs, Colo., said, "How much sex education is appropriate for a five-year-old? In my mind, zero is the right number."
Obama on Thursday said, "We have to deal with a coarsening of the culture and the over-sexualization of our young people," adding, "Of course, part of the coarsening of that culture is when politicians try to demagogue issues to score cheap political points" (Davenport, AP/ABC News, 6/19).
Romney, Fred Thompson Vie for Social Conservative Support
The Los Angeles Times on Friday examined a recent "clash" between Romney and former Sen. Fred Thompson (Tenn.), who is expected to announce his candidacy for the Republican presidential nomination, over support of social conservatives. According to the Times, neither candidate is a "sure bet" with social conservatives, particularly because of abortion issues. Both Romney and Thompson have said they oppose abortion rights, but both candidates also have "mixed" records on the issue, the Times reports (Finnegan, Los Angeles Times, 7/20).
ABC News video of Romney's and Obama's remarks and expanded ABC News coverage are available online (ABC News, 7/19).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
четверг, 13 октября 2011 г.
Clinical Trial Data Documenting Improved Menopause Symptoms
SE5-OH containing Natural S-equol, a novel soy germ-based ingredient in a supplement, improved menopausal symptoms, including significantly reducing hot flash frequency by nearly 59 percent, according to a peer-reviewed study in Japanese women. This key study was presented in an oral presentation at the North American Menopause Society (NAMS) 20th annual meeting. A second oral presentation reported peer-reviewed data that documented for the first time the pharmacokinetics, or absorption and distribution in the body, in U.S. menopausal women of S-equol when taken as a supplement using SE5-OH containing Natural S-equol. Development and ongoing research of SE5-OH containing Natural S-equol is conducted by the Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. Pharmavite LLC, the makers of NatureMade® vitamins and minerals and a subsidiary of Otsuka Pharmaceutical Co., Ltd., is studying SE5-OH containing Natural S-equol in supplement form for management of menopausal symptoms.
"Natural S-equol, a soy-derived compound that is thought to interact with specific estrogen receptors, has been studied for its benefits in relieving menopausal symptoms in both U.S. and Japanese women. The data presented at NAMS adds to this research and illustrates the potential that SE5-OH containing Natural S-equol has for management of menopausal symptoms. Pharmavite LLC and Otsuka Pharmaceutical Co., Ltd. have a rigorous program, including additional clinical studies, to develop a SE5-OH containing Natural S-equol supplement," said Belinda H. Jenks, Ph.D., director of Scientific Affairs & Nutrition Education at Pharmavite LLC.
Soybeans contain a compound daidzein that certain bacteria living within the digestive tract of some individuals can metabolize, or convert, into Natural S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman], a compound thought to act as a selective estrogen receptor modulator (SERM). SERMs can bind to the body's receptors for estrogen, the naturally occurring female sex hormone, and Natural S-equol has a selective affinity for the estrogen receptor beta. Not everyone can produce Natural S-equol after soy consumption, as the production depends on the types of bacteria present in the large intestine and may be influenced by the amount of soy consumed. About 50 percent of Asians and 20 to 30 percent of North Americans and Europeans, who in general consume less soy than Asians, have the ability to produce equol. Studies in Japan have documented an association between milder menopausal symptoms in equol producers as compared to non-producers, but efficacy studies of S-equol, and of SE5-OH containing Natural S-equol, have been limited.
Investigational SE5-OH Containing Natural S-equol Supplement Improves Menopause Symptoms
In the study of Japanese postmenopausal women who were equol non-producers and reported at the NAMS annual meeting, a supplement whose active ingredient was SE5-OH containing Natural S-equol had significant effects on improving several menopausal symptoms.
"Our clinical trial of SE5-OH containing Natural S-equol in Japanese post-menopausal women documented a significant reduction of their menopausal symptoms as measured in several ways, and the compound appears to have a promising future role in the management of women's menopausal symptoms," said study author Takashi Aso, M.D., Ph.D., of the Department of Obstetrics and Gynecology, Faculty of Medicine, Tokyo Medical and Dental University and past president of the Japanese Menopause Society. "Safe and effective alternatives to hormone replacement therapy are needed to help women who suffer from menopause symptoms."
In the study, women taking a daily oral dose of 10 milligrams (mg) of Natural S-equol via the supplement reduced their frequency of hot flashes by 58.7 percent after 12 weeks of treatment, significantly more than the 34.5 percent reduction experienced in women receiving a placebo (p=0.0092 ). The study's primary endpoint was individual menopause symptom scores after 12 weeks of treatment.
SE5-OH containing Natural S-equol also yielded positive improvements of other menopause symptoms, as measured by the study's several secondary endpoints, including total scores on menopausal symptom evaluations as assessed by a physician-administered 22-item menopausal symptom questionnaire and by a validated tool called the Visual Analogue Scale of five symptoms (hot flashes, sweating, light sleep insomnia, depression and shoulder muscle stiffness). Women in Japan in general experience less hot flashes than women in the United States but experience more neck and shoulder stiffness, the investigators noted.
The trial also evaluated safety and adverse treatment-related effects. No adverse events were reported in this study and the supplement was well tolerated. A complete report of the study data will be submitted for peer-review publication.
The trial, a randomized, double-blind, placebo-controlled, parallel-group study, evaluated 230 post-menopausal Japanese women aged 45 to 60 years. At enrollment, the women had at least one hot flash per day, did not produce equol after eating soy products, and did not take hormonal drugs or menopause symptom treatments. The postmenopausal enrollment criteria included estrogen levels of less than 21 picograms per milliliter (ml) and follicle stimulating hormone (FSH) values greater than 30 million international units/ml. Investigators randomized the women into two groups to receive either the placebo or the supplement, in the form of two daily tablets taken for 12 weeks.
The Natural S-equol used in this study and the pharmacokinetic study was in the form of SE5-OH containing Natural S-equol. The supplement tablets each contained 5 mg of Natural S-equol. The SE5-OH is the product of fermentation of soy germ by the bacterial strain Lactococcus garvieae 20-92 using a patented and proprietary process by the Otsuka Pharmaceutical Co., Ltd. The process results in the conversion of the daidzein to S-equol. SE5-OH is created under current Good Manufacturing Practices. Following fermentation, the bacteria undergoes heat denaturation and is deactivated. The process is designed to produce a Natural S-equol rich product, or nutraceutical ingredient.
SE5-OH Containing Natural S-equol Supplements Provide Very High Systemic Bioavailability
The S-equol in SE5-OH containing Natural S-equol supplement tablets was rapidly absorbed from the tablets and attained optimal concentrations in the blood stream, providing very high systemic bioavailability when given to healthy postmenopausal women. These findings were from a single-center, open-label, randomized, two-period crossover study conducted in white, non-Hispanic women. Bioavailability is a calculation of how much of a given dose of a test compound reaches the blood stream to circulate within the body, has a potential therapeutic effect and then is excreted in urine.
"These data are the first to report the pharmacokinetics of the S-equol when given in the SE5-OH containing Natural S-equol supplements to healthy U.S. postmenopausal women. This information is fundamental to determine the best dose of S-equol to use in the design of future clinical studies aimed at evaluating the effectiveness of S-equol in hormone-dependent conditions, such as menopause. We also documented that the SE5-OH Natural S-equol supplement offers a means of providing S-equol to those adults that do not produce it after ingestion of soy," said Kenneth D. R. Setchell, Ph.D., professor in the Division of Pathology and Laboratory Investigation, Department of Pediatrics, Cincinnati Children's Hospital Medical Center in Ohio. Dr. Setchell, an expert pharmacologist, evaluated the blinded data from the trial, which was conducted by Community Research in Cincinnati, Ohio, with support from Otsuka Pharmaceutical Development and Commercialization, Inc.
In the study, investigators randomly assigned 12 post-menopausal women, aged 48 to 65 years, to receive after fasting overnight either 10 mg or 30 mg of S-equol via SE5-OH containing Natural S-equol supplement tablets that each contained 5 mg of S-equol. Then 48 hours later, the women were switched to the other dosage. Following the 30 mg dose, the average peak plasma concentration, a calculation called Cmax, of Natural S-equol was 1,200 nanomoles per liter and was reached one hour after dosing.
Values for measures were similar for both doses of S-equol. Three of these measures included the calculation of Natural S-equol plasma concentration following each dosing, called an Area Under the Curve (AUC) calculation, and both Cmax and AUC calculated by dose. Also, S-equol from the SE5-OH containing Natural S-equol supplement was rapidly excreted in urine. The average half-life, the time for plasma concentrations to decrease by 50 percent, was eight hours but sustained concentrations were measureable through 48 hours after dosing. The fraction of the S-equol dose excreted in urine was more than 80 percent for both doses. A complete report of the study data will be submitted for peer-review publication.
Investigators determined that three of the 12 women (25 percent) were equol-producers, based on their equol levels after a soymilk challenge. This standard test for equol production in humans includes a three-day soy milk challenge followed by measures of urinary equol concentration on day four of the test. There were no observable differences in Natural S-equol pharmacokinetics between the equol-producers and non-producers in the study, the investigators note.
No serious adverse events were reported and nor were there any clinically important changes in the women's blood biochemistry, including FSH, triiodothyronine, thyroxine, and thyroid-stimulating hormone, or in hematology, urinalysis or vital signs after administration of the Natural S-equol supplements.
For this pharmacokinetics trial, the women's postmenopausal status enrollment criteria was serum estradiol values of less than 100 picomol per liter and FSH levels greater than 50 international units per liter. Participants could not take any prescription or over-the-counter estrogen, combination estrogen+progestin, or phytoestrogen products within 14 days before the Natural S-equol dosing. The women also had to abstain from consuming soy-, flax- or lignan-containing foods, beverages and supplements for seven days before the equol dosing.
Otsuka Pharmaceutical Co. Ltd. supported both studies.
Oral presentation
Pharmacokinetics of S-(-)-Equol Administered as SE5-OH Tablets to Healthy Postmenopausal Women Kenneth D. R. Setchell and Xueheng Zhao (Cincinnati Children's Hospital Medical Center and Cincinnati College of Medicine, Ohio); and Susan E. Shoaf and Karen Ragland (Global Clinical Development, Otsuka Pharmaceutical Development and Commercialization, Inc., Rockville, Md.)
Oral presentation
The Physiological Effects of Natural S-Equol Tablets on Menopausal Symptoms of Japanese Post-Menopausal Women Takeshi Aso, (Tokyo Medical and Dental University); Masahiro Nozaki (Kyushu Central Hospital, Fukuoka, Japan); Hiroaki Ohta (Tokyo Women's Medical University, Japan); and Tomomi Ueno and Shigeto Uchiyama (Saga Nutraceutical research Institute, Otsuka Pharmaceutical Co. Ltd., Japan).
Source:
Stephen McCauley
Porter Novelli
View drug information on Estradiol Transdermal System.
"Natural S-equol, a soy-derived compound that is thought to interact with specific estrogen receptors, has been studied for its benefits in relieving menopausal symptoms in both U.S. and Japanese women. The data presented at NAMS adds to this research and illustrates the potential that SE5-OH containing Natural S-equol has for management of menopausal symptoms. Pharmavite LLC and Otsuka Pharmaceutical Co., Ltd. have a rigorous program, including additional clinical studies, to develop a SE5-OH containing Natural S-equol supplement," said Belinda H. Jenks, Ph.D., director of Scientific Affairs & Nutrition Education at Pharmavite LLC.
Soybeans contain a compound daidzein that certain bacteria living within the digestive tract of some individuals can metabolize, or convert, into Natural S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman], a compound thought to act as a selective estrogen receptor modulator (SERM). SERMs can bind to the body's receptors for estrogen, the naturally occurring female sex hormone, and Natural S-equol has a selective affinity for the estrogen receptor beta. Not everyone can produce Natural S-equol after soy consumption, as the production depends on the types of bacteria present in the large intestine and may be influenced by the amount of soy consumed. About 50 percent of Asians and 20 to 30 percent of North Americans and Europeans, who in general consume less soy than Asians, have the ability to produce equol. Studies in Japan have documented an association between milder menopausal symptoms in equol producers as compared to non-producers, but efficacy studies of S-equol, and of SE5-OH containing Natural S-equol, have been limited.
Investigational SE5-OH Containing Natural S-equol Supplement Improves Menopause Symptoms
In the study of Japanese postmenopausal women who were equol non-producers and reported at the NAMS annual meeting, a supplement whose active ingredient was SE5-OH containing Natural S-equol had significant effects on improving several menopausal symptoms.
"Our clinical trial of SE5-OH containing Natural S-equol in Japanese post-menopausal women documented a significant reduction of their menopausal symptoms as measured in several ways, and the compound appears to have a promising future role in the management of women's menopausal symptoms," said study author Takashi Aso, M.D., Ph.D., of the Department of Obstetrics and Gynecology, Faculty of Medicine, Tokyo Medical and Dental University and past president of the Japanese Menopause Society. "Safe and effective alternatives to hormone replacement therapy are needed to help women who suffer from menopause symptoms."
In the study, women taking a daily oral dose of 10 milligrams (mg) of Natural S-equol via the supplement reduced their frequency of hot flashes by 58.7 percent after 12 weeks of treatment, significantly more than the 34.5 percent reduction experienced in women receiving a placebo (p=0.0092 ). The study's primary endpoint was individual menopause symptom scores after 12 weeks of treatment.
SE5-OH containing Natural S-equol also yielded positive improvements of other menopause symptoms, as measured by the study's several secondary endpoints, including total scores on menopausal symptom evaluations as assessed by a physician-administered 22-item menopausal symptom questionnaire and by a validated tool called the Visual Analogue Scale of five symptoms (hot flashes, sweating, light sleep insomnia, depression and shoulder muscle stiffness). Women in Japan in general experience less hot flashes than women in the United States but experience more neck and shoulder stiffness, the investigators noted.
The trial also evaluated safety and adverse treatment-related effects. No adverse events were reported in this study and the supplement was well tolerated. A complete report of the study data will be submitted for peer-review publication.
The trial, a randomized, double-blind, placebo-controlled, parallel-group study, evaluated 230 post-menopausal Japanese women aged 45 to 60 years. At enrollment, the women had at least one hot flash per day, did not produce equol after eating soy products, and did not take hormonal drugs or menopause symptom treatments. The postmenopausal enrollment criteria included estrogen levels of less than 21 picograms per milliliter (ml) and follicle stimulating hormone (FSH) values greater than 30 million international units/ml. Investigators randomized the women into two groups to receive either the placebo or the supplement, in the form of two daily tablets taken for 12 weeks.
The Natural S-equol used in this study and the pharmacokinetic study was in the form of SE5-OH containing Natural S-equol. The supplement tablets each contained 5 mg of Natural S-equol. The SE5-OH is the product of fermentation of soy germ by the bacterial strain Lactococcus garvieae 20-92 using a patented and proprietary process by the Otsuka Pharmaceutical Co., Ltd. The process results in the conversion of the daidzein to S-equol. SE5-OH is created under current Good Manufacturing Practices. Following fermentation, the bacteria undergoes heat denaturation and is deactivated. The process is designed to produce a Natural S-equol rich product, or nutraceutical ingredient.
SE5-OH Containing Natural S-equol Supplements Provide Very High Systemic Bioavailability
The S-equol in SE5-OH containing Natural S-equol supplement tablets was rapidly absorbed from the tablets and attained optimal concentrations in the blood stream, providing very high systemic bioavailability when given to healthy postmenopausal women. These findings were from a single-center, open-label, randomized, two-period crossover study conducted in white, non-Hispanic women. Bioavailability is a calculation of how much of a given dose of a test compound reaches the blood stream to circulate within the body, has a potential therapeutic effect and then is excreted in urine.
"These data are the first to report the pharmacokinetics of the S-equol when given in the SE5-OH containing Natural S-equol supplements to healthy U.S. postmenopausal women. This information is fundamental to determine the best dose of S-equol to use in the design of future clinical studies aimed at evaluating the effectiveness of S-equol in hormone-dependent conditions, such as menopause. We also documented that the SE5-OH Natural S-equol supplement offers a means of providing S-equol to those adults that do not produce it after ingestion of soy," said Kenneth D. R. Setchell, Ph.D., professor in the Division of Pathology and Laboratory Investigation, Department of Pediatrics, Cincinnati Children's Hospital Medical Center in Ohio. Dr. Setchell, an expert pharmacologist, evaluated the blinded data from the trial, which was conducted by Community Research in Cincinnati, Ohio, with support from Otsuka Pharmaceutical Development and Commercialization, Inc.
In the study, investigators randomly assigned 12 post-menopausal women, aged 48 to 65 years, to receive after fasting overnight either 10 mg or 30 mg of S-equol via SE5-OH containing Natural S-equol supplement tablets that each contained 5 mg of S-equol. Then 48 hours later, the women were switched to the other dosage. Following the 30 mg dose, the average peak plasma concentration, a calculation called Cmax, of Natural S-equol was 1,200 nanomoles per liter and was reached one hour after dosing.
Values for measures were similar for both doses of S-equol. Three of these measures included the calculation of Natural S-equol plasma concentration following each dosing, called an Area Under the Curve (AUC) calculation, and both Cmax and AUC calculated by dose. Also, S-equol from the SE5-OH containing Natural S-equol supplement was rapidly excreted in urine. The average half-life, the time for plasma concentrations to decrease by 50 percent, was eight hours but sustained concentrations were measureable through 48 hours after dosing. The fraction of the S-equol dose excreted in urine was more than 80 percent for both doses. A complete report of the study data will be submitted for peer-review publication.
Investigators determined that three of the 12 women (25 percent) were equol-producers, based on their equol levels after a soymilk challenge. This standard test for equol production in humans includes a three-day soy milk challenge followed by measures of urinary equol concentration on day four of the test. There were no observable differences in Natural S-equol pharmacokinetics between the equol-producers and non-producers in the study, the investigators note.
No serious adverse events were reported and nor were there any clinically important changes in the women's blood biochemistry, including FSH, triiodothyronine, thyroxine, and thyroid-stimulating hormone, or in hematology, urinalysis or vital signs after administration of the Natural S-equol supplements.
For this pharmacokinetics trial, the women's postmenopausal status enrollment criteria was serum estradiol values of less than 100 picomol per liter and FSH levels greater than 50 international units per liter. Participants could not take any prescription or over-the-counter estrogen, combination estrogen+progestin, or phytoestrogen products within 14 days before the Natural S-equol dosing. The women also had to abstain from consuming soy-, flax- or lignan-containing foods, beverages and supplements for seven days before the equol dosing.
Otsuka Pharmaceutical Co. Ltd. supported both studies.
Oral presentation
Pharmacokinetics of S-(-)-Equol Administered as SE5-OH Tablets to Healthy Postmenopausal Women Kenneth D. R. Setchell and Xueheng Zhao (Cincinnati Children's Hospital Medical Center and Cincinnati College of Medicine, Ohio); and Susan E. Shoaf and Karen Ragland (Global Clinical Development, Otsuka Pharmaceutical Development and Commercialization, Inc., Rockville, Md.)
Oral presentation
The Physiological Effects of Natural S-Equol Tablets on Menopausal Symptoms of Japanese Post-Menopausal Women Takeshi Aso, (Tokyo Medical and Dental University); Masahiro Nozaki (Kyushu Central Hospital, Fukuoka, Japan); Hiroaki Ohta (Tokyo Women's Medical University, Japan); and Tomomi Ueno and Shigeto Uchiyama (Saga Nutraceutical research Institute, Otsuka Pharmaceutical Co. Ltd., Japan).
Source:
Stephen McCauley
Porter Novelli
View drug information on Estradiol Transdermal System.
четверг, 6 октября 2011 г.
Cervical Cancer Vaccine Could Save Nearly 193,333 Lives A Year
It is estimated that 290,000 women die of cervical cancer globally each year. If Gardasil could reduce deaths by two-thirds, as Merck claims, this would mean 193,333 women's lives saved each year. In order to be effective, Merck says it would be best to vaccinate girls before they are likely to become sexually active.
Gardasil, a vaccine, prevents infection of four types of HPV (human papillomavirus). Two of them, types 16 and 18, are responsible for the development of over two-thirds of all cervical cancers. The other two types are responsible for most genital warts.
Merck says this could be the biggest cervical cancer prevention leap since the PAP test.
Today, an FDA Adisory Panel must decide whether or not to recommend Gardasil for approval. The Panel does not approve new drugs, it just recommends whether or not they should be approved. The FDA itself approves or declines drug applications. However, the FDA usually does what the Panel recommends. A decision on Gardasil is expected on 8 June.
HPV is a sexually transmitted infection (STI) and is present in about half of all sexually active adults.
If people who are already HPV infected take the vaccine and their immune systems have not cleared the virus from their systems, their risk of having a cancer precursor is higher. Five women who had the vaccine at about the same time as they became pregnant (conception) went on to have babies with birth defects.
The vaccine will not be cheap. A course of three injections over a six month period will cost from $300 to $500.
View drug information on Gardasil.
Gardasil, a vaccine, prevents infection of four types of HPV (human papillomavirus). Two of them, types 16 and 18, are responsible for the development of over two-thirds of all cervical cancers. The other two types are responsible for most genital warts.
Merck says this could be the biggest cervical cancer prevention leap since the PAP test.
Today, an FDA Adisory Panel must decide whether or not to recommend Gardasil for approval. The Panel does not approve new drugs, it just recommends whether or not they should be approved. The FDA itself approves or declines drug applications. However, the FDA usually does what the Panel recommends. A decision on Gardasil is expected on 8 June.
HPV is a sexually transmitted infection (STI) and is present in about half of all sexually active adults.
If people who are already HPV infected take the vaccine and their immune systems have not cleared the virus from their systems, their risk of having a cancer precursor is higher. Five women who had the vaccine at about the same time as they became pregnant (conception) went on to have babies with birth defects.
The vaccine will not be cheap. A course of three injections over a six month period will cost from $300 to $500.
View drug information on Gardasil.
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