Starting Sept. 23 -- six months after the law's passage -- many health plans will be required to cover certain preventive services without charging policyholders copayments or out-of-pocket costs. An amendment by Sen. Barbara Mikulski (D-Md.) states that "additional preventive care and screenings" specific to women's health must be included in the coverage. Rachel MacKnight, a spokesperson for Mikulski, said the senator's "intention was to have preventive services provided for women at no additional cost, no deductibles." She added, "From [Mikulski's] perspective, that includes everything from heart disease screening and diabetes screening to mammograms to birth control."
The Health Resources and Services Administration is tasked with creating "comprehensive guidelines" on which women's health services will be included. HRSA Communications Director Martin Kramer said the agency has "six months from passage to come up with that, and it's still being worked on." HHS spokesperson Jessica Santillo said the department "is working through a deliberative process to develop the guidelines as called for in the statute."
Laurie Rubiner, vice president of public policy for the Planned Parenthood Federation of America, said the group "see[s] this as a tremendous opportunity to get no-cost birth control in the bill and ensure that this part of women's health is covered under preventive health."
According to the Guttmacher Institute, about 90% of employer-based health insurance plans cover prescription birth control. Copays for contraceptives can range from $10 to $50 monthly, depending on the brand and type, according to PPFA. "We still have one of the highest abortion rates of developed countries," Rubiner said, adding, "One of the single biggest reasons is that contraception is still financially out of reach for many women."
Planned Parenthood's campaign includes a new website featuring the slogan, "The Pill is Personal." On the site, birth control users are encouraged to share personal stories about how the pill has affected their lives and the lives of people they know. According to Politico, PPFA will use the stories to illustrate the importance of birth control coverage. Rubiner said, "This needs to be based on science and medical evidence, but ... it is also really important to hear the stories of how women view birth control, the health impact and the affordability issue."
Other reproductive health groups are also focused on this issue. Laura MacCleery, director of governmental relations for the Center for Reproductive Rights, said, "We're actively pursuing what we think falls within the appropriate boundaries of the coverage of this amendment."
Several religious groups opposed to contraception are campaigning against birth control coverage, Politico reports. U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities Richard Doerflinger said, "Congressional debate on the need to cover 'preventive services' in health care reform centered on services needed to prevent life-threatening diseases like breast cancer, not on a need to prevent the birth of new recipients of health care." He added, "Requiring contraception and sterilization in all private health plans would be an enormous imposition on the consciences of religious organizations and others who now have the right to purchase a health plan in accord with their moral and religious values" (Kliff, Politico, 6/1).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
© 2010 National Partnership for Women & Families. All rights reserved.
вторник, 24 апреля 2012 г.
Planned Parenthood Advocates For Birth Control Coverage As Part Of Preventive Services
Planned Parenthood has launched a "quiet" campaign urging policymakers to include birth control in the preventive services that health plans must cover under the federal health care reform law (PL 111-148), Politico reports.
вторник, 17 апреля 2012 г.
Why Are African American Women More Likely Than Whites To Die From Breast Cancer?
Why are African American women 1.5 to 2.2 times more likely than white women to die from breast cancer, despite their lower incidence of the disease? Is it solely because they have less access to medical care? Maybe not, according to a new analysis that will appear in an upcoming issue of the International Journal of Surgery. In a paper now available online, researchers propose that the excess mortality occurs partly because black women are more likely than white women to develop breast cancer before menopause, when surgery to remove the tumor may pose a higher risk of stimulating cancer growth.
The researchers, led by Michael Retsky, PhD in the Vascular Biology Program at Children's Hospital Boston, note that African American women are diagnosed with breast cancer at an average age of 46, versus 57 for white women, and that their excess mortality first appeared in the mid-1970s, just when mammography for early detection was introduced. Early breast cancer detection leads to earlier surgical removals, which may actually spur relapse in some premenopausal cancer patients, the researchers say.
"Looking at what's happening in African American women provides a research opportunity to learn how to better screen for and treat premenopausal breast cancer overall," says Retsky. "There's much to learn that might translate into improved outcomes for all premenopausal women."
The analysis extends an earlier analysis published in 2005, which suggested that undergoing surgery before menopause may actually encourage early metastasis and relapse. That paper analyzed data from 1,173 women in Italy who had breast cancer surgery, and found that, among those with lymph node-positive cancer, 20 percent of premenopausal women relapsed within 10 months after surgery double the relapse rate in women diagnosed after menopause. The researchers suggested that these early relapses help explain the "mammography paradox" the puzzling observation that mammography screening in women aged 40 to 49 has significantly less benefit than in women aged 50 to 59.
The 2005 paper sparked a flurry of correspondence that led to the new analysis. One letter noted a commonly held belief in the African American community that "exposing a cancer to air" will cause it to spread, an idea often dismissed as superstition. Another letter, from Nigerian physician Isaac Gukas, MD, PhD, observed that over 70 percent of the breast cancer patients he saw in Africa were under age 45, and that they had a poor survival rate, often rapidly deteriorating after surgery. According to Gukas, it is common in Africa for women to seek alternative care before eventually presenting to a physician with locally advanced disease, for fear that treatment will "provoke" the cancer.
"These letters were compelling and impossible to ignore," says Retsky. "There may be some scientific basis for these folk sayings. We were unaware there was a racial difference in age of breast cancer diagnosis, and it has led us in a major new research direction." Gukas, now at the University of East Anglia (Norwich, UK), is a co-author on the current paper.
Although the researchers did not directly study the biological mechanisms of cancer relapse, they suggest that in women diagnosed before menopause, surgery is more likely to stimulate angiogenesis growth of new blood vessels which in turn spurs the growth of tiny, dormant metastases. They cite a large body of laboratory and animal data showing that primary tumors secrete angiogenesis inhibitors, and that surgical removal eliminates this inhibition and spurs the release of angiogenesis promoters in a wound-healing response. They also cite data showing hormonal differences between black and white women, which may influence angiogenesis and metastasis acceleration.
The researchers do not recommend any changes in screening or treatment protocols for breast cancer, feeling that more research is needed. They propose a number of ways to test their hypothesis:
-- By comparing blood vessel growth in primary versus recurrent tumors from black and white premenopausal and postmenopausal women;
--By measuring angiogenesis inhibitors and promoters, before and after surgery, in premenopausal versus postmenopausal women and in black versus white women, and comparing these findings to cancer recurrence;
-- By conducting comparative genetic studies in black and white women to determine possible differences in activity of the genes that control angiogenesis.
"We do not have enough evidence to alter treatment schedules as of now," Gukas cautions. "However, if additional studies confirm our hypothesis, we may need to give these premenopausal women appropriate chemotherapy, including angiogenesis inhibitors, before surgery to ensure the best outcome."
Other co-authors were Romano Demicheli, MD, PhD, of the Istituto Nazionale Tumori (Milan, Italy) and William Hrushesky, MD, of the University of South Carolina.
Children's Hospital Boston is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 500 scientists, including eight members of the National Academy of Sciences, 11 members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Children's research community. Founded as a 20-bed hospital for children, Children's Hospital Boston today is a 347-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children's also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about the hospital and its research visit: childrenshospital/newsroom.
Children's Hospital Boston
21 Autumn St., 2nd Fl.
Boston, MA 02115
United States
childrenshospital/
The researchers, led by Michael Retsky, PhD in the Vascular Biology Program at Children's Hospital Boston, note that African American women are diagnosed with breast cancer at an average age of 46, versus 57 for white women, and that their excess mortality first appeared in the mid-1970s, just when mammography for early detection was introduced. Early breast cancer detection leads to earlier surgical removals, which may actually spur relapse in some premenopausal cancer patients, the researchers say.
"Looking at what's happening in African American women provides a research opportunity to learn how to better screen for and treat premenopausal breast cancer overall," says Retsky. "There's much to learn that might translate into improved outcomes for all premenopausal women."
The analysis extends an earlier analysis published in 2005, which suggested that undergoing surgery before menopause may actually encourage early metastasis and relapse. That paper analyzed data from 1,173 women in Italy who had breast cancer surgery, and found that, among those with lymph node-positive cancer, 20 percent of premenopausal women relapsed within 10 months after surgery double the relapse rate in women diagnosed after menopause. The researchers suggested that these early relapses help explain the "mammography paradox" the puzzling observation that mammography screening in women aged 40 to 49 has significantly less benefit than in women aged 50 to 59.
The 2005 paper sparked a flurry of correspondence that led to the new analysis. One letter noted a commonly held belief in the African American community that "exposing a cancer to air" will cause it to spread, an idea often dismissed as superstition. Another letter, from Nigerian physician Isaac Gukas, MD, PhD, observed that over 70 percent of the breast cancer patients he saw in Africa were under age 45, and that they had a poor survival rate, often rapidly deteriorating after surgery. According to Gukas, it is common in Africa for women to seek alternative care before eventually presenting to a physician with locally advanced disease, for fear that treatment will "provoke" the cancer.
"These letters were compelling and impossible to ignore," says Retsky. "There may be some scientific basis for these folk sayings. We were unaware there was a racial difference in age of breast cancer diagnosis, and it has led us in a major new research direction." Gukas, now at the University of East Anglia (Norwich, UK), is a co-author on the current paper.
Although the researchers did not directly study the biological mechanisms of cancer relapse, they suggest that in women diagnosed before menopause, surgery is more likely to stimulate angiogenesis growth of new blood vessels which in turn spurs the growth of tiny, dormant metastases. They cite a large body of laboratory and animal data showing that primary tumors secrete angiogenesis inhibitors, and that surgical removal eliminates this inhibition and spurs the release of angiogenesis promoters in a wound-healing response. They also cite data showing hormonal differences between black and white women, which may influence angiogenesis and metastasis acceleration.
The researchers do not recommend any changes in screening or treatment protocols for breast cancer, feeling that more research is needed. They propose a number of ways to test their hypothesis:
-- By comparing blood vessel growth in primary versus recurrent tumors from black and white premenopausal and postmenopausal women;
--By measuring angiogenesis inhibitors and promoters, before and after surgery, in premenopausal versus postmenopausal women and in black versus white women, and comparing these findings to cancer recurrence;
-- By conducting comparative genetic studies in black and white women to determine possible differences in activity of the genes that control angiogenesis.
"We do not have enough evidence to alter treatment schedules as of now," Gukas cautions. "However, if additional studies confirm our hypothesis, we may need to give these premenopausal women appropriate chemotherapy, including angiogenesis inhibitors, before surgery to ensure the best outcome."
Other co-authors were Romano Demicheli, MD, PhD, of the Istituto Nazionale Tumori (Milan, Italy) and William Hrushesky, MD, of the University of South Carolina.
Children's Hospital Boston is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 500 scientists, including eight members of the National Academy of Sciences, 11 members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Children's research community. Founded as a 20-bed hospital for children, Children's Hospital Boston today is a 347-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children's also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about the hospital and its research visit: childrenshospital/newsroom.
Children's Hospital Boston
21 Autumn St., 2nd Fl.
Boston, MA 02115
United States
childrenshospital/
вторник, 10 апреля 2012 г.
FDA delays decision on OTC emergency contraceptive, Plan B
Barr Pharmaceuticals, Inc confirmed that the US Food and Drug Administration (FDA) has informed the Company that it is
unable to complete its review of the Company's Supplemental New Drug Application (sNDA) to market the Plan B(R)
(levonorgestrel) emergency contraceptive Over-The-Counter (OTC) by the January 21st Prescription Drug User Fee Act (PDUFA)
date. The FDA also indicated to the Company that it is committed to completing its review of the application in the near
future. The Company remains optimistic that the agency will approve Plan B for OTC sale. Plan B continues to be available to
American consumers by prescription.
The Company's sNDA, if approved, would permit the OTC sale of Plan B without a prescription for women 16 years of age and
older. It would maintain the prescription status for women age 15 years of age and younger.
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a
single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment
increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay
in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be
removed, including making the product broadly available without prescription.
Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency
contraception is currently available in some pharmacies without an advance prescription from a physician or healthcare
provider in six U.S. states (Alaska, California, Hawaii, Maine, New Mexico and Washington).
Plan B was approved by the FDA in 1999 as a safe and effective prescription only emergency contraceptive for women. Plan B is
the first progestin-only emergency contraceptive. The application seeking over-the- counter status for Plan B was filed with
FDA in 2003. In May 2004 the FDA issued a Not Approvable Letter offering Barr the option of seeking dual status that would
make the product available over-the-counter for women 16 years of age and older, and by prescription only for women under the
age 15.
Contraindications for Plan B(R)
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are
contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of
the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected
pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.
Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and
proprietary pharmaceuticals.
Forward-Looking Statements
Except for the historical information contained herein, the statements made in this press release constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will,"
"may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such
statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ
materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting
the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal
proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome
of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of
predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend
exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the
costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from
significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products;
the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the
availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory
environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the
availability of product liability insurance coverage; our timely and successful completion of strategic initiatives,
including integrating companies and products we acquire and implementing our new enterprise resource planning system;
fluctuations in operating results, including the effects on such results from spending for research and development, sales
and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections;
changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the
Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company
undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except to the extent required under applicable law.
barrlabs
unable to complete its review of the Company's Supplemental New Drug Application (sNDA) to market the Plan B(R)
(levonorgestrel) emergency contraceptive Over-The-Counter (OTC) by the January 21st Prescription Drug User Fee Act (PDUFA)
date. The FDA also indicated to the Company that it is committed to completing its review of the application in the near
future. The Company remains optimistic that the agency will approve Plan B for OTC sale. Plan B continues to be available to
American consumers by prescription.
The Company's sNDA, if approved, would permit the OTC sale of Plan B without a prescription for women 16 years of age and
older. It would maintain the prescription status for women age 15 years of age and younger.
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a
single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment
increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay
in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be
removed, including making the product broadly available without prescription.
Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency
contraception is currently available in some pharmacies without an advance prescription from a physician or healthcare
provider in six U.S. states (Alaska, California, Hawaii, Maine, New Mexico and Washington).
Plan B was approved by the FDA in 1999 as a safe and effective prescription only emergency contraceptive for women. Plan B is
the first progestin-only emergency contraceptive. The application seeking over-the- counter status for Plan B was filed with
FDA in 2003. In May 2004 the FDA issued a Not Approvable Letter offering Barr the option of seeking dual status that would
make the product available over-the-counter for women 16 years of age and older, and by prescription only for women under the
age 15.
Contraindications for Plan B(R)
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are
contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of
the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected
pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.
Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and
proprietary pharmaceuticals.
Forward-Looking Statements
Except for the historical information contained herein, the statements made in this press release constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will,"
"may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such
statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ
materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting
the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal
proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome
of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of
predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend
exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the
costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from
significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products;
the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the
availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory
environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the
availability of product liability insurance coverage; our timely and successful completion of strategic initiatives,
including integrating companies and products we acquire and implementing our new enterprise resource planning system;
fluctuations in operating results, including the effects on such results from spending for research and development, sales
and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections;
changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the
Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company
undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except to the extent required under applicable law.
barrlabs
вторник, 3 апреля 2012 г.
New Risk Factor For Melanoma In Younger Women Revealed By NYU Study
Researchers may have found a more potent risk factor for melanoma than blistering sunburns, freckling, or family history of the deadly skin disease. In a new study, scientists at NYU Langone Medical Center report that a genetic variation leads to a nearly four-fold increase of melanoma in women under the age of 50. The new study was released online March 24, 2009, in the journal Clinical Cancer Research and will be published in the April 1, 2009, issue of the journal.
"If this number turns out to be reproducible, it is higher than a lot of the other clinical risk factors that we know, such as blistering sunburns, freckling, and family history," said David Polsky, M.D., Ph.D., associate professor of dermatology and director of the Pigmented Lesion Section of the Ronald O. Perelman Department of Dermatology at NYU School of Medicine, and the study's lead author.
"Potentially, we have a genetic test that might identify pre-menopausal women who are at higher risk for melanoma," said Dr. Polsky. "And if that's the case, then we might want to have increased surveillance of those patients including more frequent visits to the doctor, more rigorous teaching of skin self-examination, and other preventive steps."
Melanoma, the most deadly form of skin cancer, was expected last year to strike 62,480 Americans, and kill an estimated 8,420 diagnosed patients, according to the American Cancer Society.
For largely unknown reasons, melanoma is more common among women than men under the age of 40. Between 40 and 50 the incidence is about equal in both sexes, and over the age of 50, melanoma incidence skews markedly toward men. Polsky and his co-authors suspect the difference may be linked to the activity of estrogen, mediated in part by a genetic variant in a gene called MDM2.
When estrogen binds to this gene, it turns on production of MDM2, a potential oncogene (cancer promoting gene) in cells. In the presence of the genetic variation in MDM2, originally identified by the laboratory of Dr. Arnold Levine at the Institute for Advanced Study, Princeton, the estrogen binds more strongly, resulting in far greater production of the MDM2 protein.
Women with higher estrogen levels and who also have the genetic variation would be expected to have higher estrogen-related MDM2 protein that could increase their melanoma risk, explains Dr. Polsky.
The MDM2 genetic variant appears in the gene's promoter, a power switch that determines when the gene is turned on and how many copies are produced within a cell. This promoter region is normally regulated by p53, a tumor suppressor gene implicated in as many of 50 percent of all cancers. Part of MDM2's normal function is to inhibit p53 when its levels get too high in a cell. If MDM2 is turned on independently of p53, it can keep p53 levels low, reducing the cell's protection against turning into a cancer cell.
Scientists have shown that the substitution of a single letter of DNA at a specific point in the MDM2 promoter can significantly ramp up gene production. The new study evaluated the effects of this natural genetic variation in 227 melanoma patients enrolled in NYU's Interdisciplinary Melanoma Cooperative Group between August 2002 and November 2006. Dr. Polsky and colleagues from NYU School of Medicine recorded each patient's MDM2 and p53 genetic variations, as well as age, sex, personal and family history of melanoma, and tumor thickness.
The results showed that more than 40 percent of women diagnosed with melanoma under the age of 50 had the genetic variation in the MDM2 gene promoter. In contrast, only about 16 percent of women diagnosed after the age of 50 had the variation.
The difference in the frequency of the variation corresponded to a 3.89-fold increase in melanoma risk for women under the age of 50 - an elevated risk over background levels that increased more among even younger women, according to the study. When the researchers compared the MDM2 genotypes to patients' ages at diagnosis, they found that about 38 percent of women with the variation had been diagnosed between the relatively young ages of 30 to 39 - a much higher melanoma incidence than among older women patients with the variation.
Beyond validating the risk in a larger group of patients, Dr. Polsky hopes to begin formulating a stronger model of cancer risk that incorporates genetic information and other factors. "Can we look at people's sun exposure history, hormonal status and a panel of genetic markers in addition to MDM2 and ask, 'Does this help identify more high-risk people?'" he said.
Notes:
Among the study investigators are Elnaz F. Firoz, a medical student from the College of Physicians and Surgeons at Columbia University; and Richard Shapiro, Russell Berman, Anna Pavlick, Prashiela Manga, Harry Ostrer, Hideko Kamino, Farbod Darvishian, Linda Rolnitzky, Judith D. Goldberg, and Iman Osman from NYU Langone Medical Center.
The study was supported by a grant from the Marc Jacobs Campaign to Support Melanoma Research, with partial support by a grant from the National Cancer Institute to Linda Rolnitzky and Judith D. Goldberg. The NYU Interdisciplinary Melanoma Cooperative Group is supported by the NYU Cancer Institute and NYU School of Medicine's Ronald O. Perelman Department of Dermatology.
About NYU LANGONE MEDICAL CENTER
One of the world's premier academic medical institutions for more than 167 years, NYU Langone Medical Center continues to be a leader in patient care, physician education and scientific research. NYU Langone Medical Center is internationally renowned for excellence in areas such as cardiovascular disease, orthopaedics, pediatrics, skin care, neurosurgery, urology, cancer care, rehabilitation medicine, plastic surgery, imaging, minimally invasive surgery, transplant surgery, infertility, and women's health.
Source:
Lorinda Klein
NYU Langone Medical Center / New York University School of Medicine
"If this number turns out to be reproducible, it is higher than a lot of the other clinical risk factors that we know, such as blistering sunburns, freckling, and family history," said David Polsky, M.D., Ph.D., associate professor of dermatology and director of the Pigmented Lesion Section of the Ronald O. Perelman Department of Dermatology at NYU School of Medicine, and the study's lead author.
"Potentially, we have a genetic test that might identify pre-menopausal women who are at higher risk for melanoma," said Dr. Polsky. "And if that's the case, then we might want to have increased surveillance of those patients including more frequent visits to the doctor, more rigorous teaching of skin self-examination, and other preventive steps."
Melanoma, the most deadly form of skin cancer, was expected last year to strike 62,480 Americans, and kill an estimated 8,420 diagnosed patients, according to the American Cancer Society.
For largely unknown reasons, melanoma is more common among women than men under the age of 40. Between 40 and 50 the incidence is about equal in both sexes, and over the age of 50, melanoma incidence skews markedly toward men. Polsky and his co-authors suspect the difference may be linked to the activity of estrogen, mediated in part by a genetic variant in a gene called MDM2.
When estrogen binds to this gene, it turns on production of MDM2, a potential oncogene (cancer promoting gene) in cells. In the presence of the genetic variation in MDM2, originally identified by the laboratory of Dr. Arnold Levine at the Institute for Advanced Study, Princeton, the estrogen binds more strongly, resulting in far greater production of the MDM2 protein.
Women with higher estrogen levels and who also have the genetic variation would be expected to have higher estrogen-related MDM2 protein that could increase their melanoma risk, explains Dr. Polsky.
The MDM2 genetic variant appears in the gene's promoter, a power switch that determines when the gene is turned on and how many copies are produced within a cell. This promoter region is normally regulated by p53, a tumor suppressor gene implicated in as many of 50 percent of all cancers. Part of MDM2's normal function is to inhibit p53 when its levels get too high in a cell. If MDM2 is turned on independently of p53, it can keep p53 levels low, reducing the cell's protection against turning into a cancer cell.
Scientists have shown that the substitution of a single letter of DNA at a specific point in the MDM2 promoter can significantly ramp up gene production. The new study evaluated the effects of this natural genetic variation in 227 melanoma patients enrolled in NYU's Interdisciplinary Melanoma Cooperative Group between August 2002 and November 2006. Dr. Polsky and colleagues from NYU School of Medicine recorded each patient's MDM2 and p53 genetic variations, as well as age, sex, personal and family history of melanoma, and tumor thickness.
The results showed that more than 40 percent of women diagnosed with melanoma under the age of 50 had the genetic variation in the MDM2 gene promoter. In contrast, only about 16 percent of women diagnosed after the age of 50 had the variation.
The difference in the frequency of the variation corresponded to a 3.89-fold increase in melanoma risk for women under the age of 50 - an elevated risk over background levels that increased more among even younger women, according to the study. When the researchers compared the MDM2 genotypes to patients' ages at diagnosis, they found that about 38 percent of women with the variation had been diagnosed between the relatively young ages of 30 to 39 - a much higher melanoma incidence than among older women patients with the variation.
Beyond validating the risk in a larger group of patients, Dr. Polsky hopes to begin formulating a stronger model of cancer risk that incorporates genetic information and other factors. "Can we look at people's sun exposure history, hormonal status and a panel of genetic markers in addition to MDM2 and ask, 'Does this help identify more high-risk people?'" he said.
Notes:
Among the study investigators are Elnaz F. Firoz, a medical student from the College of Physicians and Surgeons at Columbia University; and Richard Shapiro, Russell Berman, Anna Pavlick, Prashiela Manga, Harry Ostrer, Hideko Kamino, Farbod Darvishian, Linda Rolnitzky, Judith D. Goldberg, and Iman Osman from NYU Langone Medical Center.
The study was supported by a grant from the Marc Jacobs Campaign to Support Melanoma Research, with partial support by a grant from the National Cancer Institute to Linda Rolnitzky and Judith D. Goldberg. The NYU Interdisciplinary Melanoma Cooperative Group is supported by the NYU Cancer Institute and NYU School of Medicine's Ronald O. Perelman Department of Dermatology.
About NYU LANGONE MEDICAL CENTER
One of the world's premier academic medical institutions for more than 167 years, NYU Langone Medical Center continues to be a leader in patient care, physician education and scientific research. NYU Langone Medical Center is internationally renowned for excellence in areas such as cardiovascular disease, orthopaedics, pediatrics, skin care, neurosurgery, urology, cancer care, rehabilitation medicine, plastic surgery, imaging, minimally invasive surgery, transplant surgery, infertility, and women's health.
Source:
Lorinda Klein
NYU Langone Medical Center / New York University School of Medicine
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