U.S. President Barack Obama Proclaims September 2014 As National Ovarian Cancer Awareness Month — What Should You Know?

Today, U.S. President Barack Obama designated September 2014 as National Ovarian Cancer Awareness Month. “This month, our Nation stands with everyone who has been touched by this disease, and we recognize all those committed to advancing the fight against this cancer through research, advocacy, and quality care. Together, let us renew our commitment to reducing the impact of ovarian cancer and to a future free from cancer in all its forms.”

Today, U.S. President Barack Obama designated September 2014 as National Ovarian Cancer Awareness Month. The Presidential Proclamation is reproduced in full below.

During National Ovarian Cancer Awareness Month, Libby’s H*O*P*E*™ will continue to honor the women who have lost their lives to the disease (including our own Elizabeth “Libby” Remick), support those who are currently battling the disease, and celebrate with those who have beaten the disease. This month, medical doctors, research scientists, and ovarian cancer advocates renew their commitment to develop a reliable early screening test, improve current treatments, discover new groundbreaking therapies, and ultimately, defeat the most lethal gynecologic cancer.

Let us begin this month with several important facts relating to ovarian cancer. Please take time to review these facts — they may save your life or that of a loved one.

Ovarian Cancer Facts

Lethality. Ovarian cancer causes more deaths than any other cancer of the female reproductive system.

Statistics. In 2014, the American Cancer Society (ACS) estimates that there will be approximately 21,980 new ovarian cancer cases diagnosed in the U.S. ACS estimates that 14,270 U.S. women will die from the disease, or about 39 women per day or 1-to-2 women every hour. This loss of life is equivalent to 28 Boeing 747 jumbo jet crashes with no survivors — each and every year.

Signs & Symptoms. Ovarian cancer is not a “silent” disease; it is a “subtle” disease. Recent studies indicate that women with ovarian cancer are more like to experience four persistent, nonspecific symptoms as compared with women in the general population, such as (i) bloating, (ii) pelvic or abdominal pain, (iii) difficulty eating or feeling full quickly, or (iv) urinary urgency or frequency. Women who experience such symptoms daily for more than a few weeks should seek prompt medical evaluation. Note: Several other symptoms have been commonly reported by women with ovarian cancer. These symptoms include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities. However, these additional symptoms are not as useful in identifying ovarian cancer because they are also found in equal frequency in women within the general population who do not have the disease.

Age. Although the median age of a woman with ovarian cancer at initial diagnosis is 63, the disease cancer can afflict adolescent, young adult, and mature women. Ovarian cancer does not discriminate based upon age.

Prevention. Pregnancy, breastfeeding, long-term use of oral contraceptives, and tubal ligation reduce the risk of developing ovarian cancer.

Risk Factors.

• BRCA Gene Mutations. Women who have had breast cancer, or who have a family history of breast cancer or ovarian cancer may have increased risk. Women who test positive for inherited mutations in the BRCA-1 or BRCA-2 gene have an increased lifetime risk of breast and ovarian cancer. A women can inherit a mutated BRCA gene from her mother or father. Women of Ashkenazi (Eastern European) Jewish ancestry are at higher risk (1 out of 40) for inherited BRCA gene mutations. Studies suggest that preventive surgery to remove the ovaries and fallopian tubes in women possessing BRCA gene mutations can decrease the risk of ovarian cancer.

• Lynch Syndrome. An inherited genetic condition called “hereditary nonpolyposis colorectal cancer” (also called “Lynch syndrome“), which significantly increases the risk of colon/rectal cancer (and also increases the risk of other types of cancers such as endometrial (uterine), stomach, breast, small bowel (intestinal), pancreatic, urinary tract, liver, kidney, and bile duct cancers), also increases ovarian cancer risk.

• Hormone Therapy. The use of estrogen alone menopausal hormone therapy may increase ovarian cancer risk. The longer estrogen alone replacement therapy is used, the greater the risk may be. The increased risk is less certain for women taking both estrogen and progesterone, although a large 2009 Danish study involving over 900,000 women suggests that combination hormone therapy may increase risk. Because some health benefits have been identified with hormone replacement therapy, a women should seek her doctor’s advice regarding risk verses benefit based on her specific factual case.

• Smoking. Smoking has been linked to an increase in mucinous epithelial ovarian cancer.

Early Detection. There is no reliable screening test for the detection of early stage ovarian cancer. Pelvic examination only occasionally detects ovarian cancer, generally when the disease is advanced. A Pap smear cannot detect ovarian cancer. However, the combination of a thorough pelvic exam, transvaginal ultrasound, and a blood test for the tumor marker CA-125 may be offered to women who are at high risk of ovarian cancer and to women who have persistent, unexplained symptoms like those listed above. This early detection strategy has shown promise in a 2013 University of Texas M.D. Anderson Cancer Center early detection study involving over 4,000 women. Importantly, another large ovarian cancer screening trial that is using similar early detection methods is under way in the United Kingdom, with results expected in 2015. The U.K. study is called “UKCTOCS” (UK Collaborative Trial of Ovarian Cancer Screening) and involves over 200,000 women aged 50-74 years.

Treatment.

• Treatment includes surgery and usually chemotherapy.

• Surgery usually includes removal of one or both ovaries and fallopian tubes (salpingo-oophorectomy), the uterus (hysterectomy), and the omentum (fatty tissue attached to some of the organs in the belly), along with biopsies of the peritoneum (lining of the abdominal cavity) and peritoneal cavity fluid.

• In younger women with very early stage tumors who wish to have children, removal of only the involved ovary and fallopian tube may be possible.

• Among patients with early ovarian cancer, complete surgical staging has been associated with better outcomes.

• For women with advanced disease, surgically removing all abdominal metastases larger than one centimeter (debulking) enhances the effect of chemotherapy and helps improve survival.

• For women with stage III ovarian cancer that has been optimally debulked, studies have shown that chemotherapy administered both intravenously and directly into the abdomen (intraperitoneally) improves survival.

• Studies have also found that ovarian cancer patients whose surgeries are performed by a board-certified gynecologic oncologist at a high quality/high surgical volume medical facility have more successful outcomes. Such medical facilities include National Cancer Institute-Designated Cancer Centers and member institutions of the National Comprehensive Cancer Network.

• Patients can enter clinical trials at the start of, during the course of, and even after, their ovarian cancer treatment(s).

• New types of treatment are being tested in ovarian and solid tumor clinical trials, including “biological therapy” and “targeted therapy.” For example, these types of treatment can exploit biological/molecular characteristics unique to an ovarian cancer patient’s specific tumor classification, or better “train” the patient’s own immune system to identify and attack her tumor cells, without harming normal cells.

Survival. 

• If diagnosed at the localized stage, the 5-year ovarian cancer survival rate is 92%; however, only about 15% of all cases are detected at an early stage, usually fortuitously during another medical procedure. The majority of cases (61%) are diagnosed at a distant or later stage of the disease.

• Overall, the 1-, 5-, and 10-year relative survival of ovarian cancer patients is 75%, 44%, and 34%, respectively.

• The 10-year relative survival rate for all disease stages combined is only 38%.

• Relative survival varies by age; women younger than 65 are twice as likely to survive 5 years (56%) following diagnosis as compared to women 65 and older (27%).

Help Spread the Word to “B-E-A-T” Ovarian Cancer

Please help us “B-E-A-T” ovarian cancer by spreading the word about the early warning signs & symptoms of the disease throughout the month of September.

B = bloating that is persistent and does not come and go

E = eating less and feeling fuller

A =abdominal or pelvic pain

T = trouble with urination (urgency or frequency)

Women who have these symptoms almost daily for more than a few weeks should see their doctor. Prompt medical evaluation may lead to detection at the earliest possible stage of the disease. As noted above, early stage diagnosis is associated with an improved prognosis.

__________________________________________________________

The White House

Office of the Press Secretary

For Immediate Release August 29, 2014

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

Ovarian cancer is the most deadly of all female reproductive system cancers. This year nearly 22,000 Americans will be diagnosed with this cancer, and more than 14,000 will die from it. The lives of mothers and daughters will be taken too soon, and the pain of this disease will touch too many families. During National Ovarian Cancer Awareness Month, we honor the loved ones we have lost to this disease and all those who battle it today, and we continue our work to improve care and raise awareness about ovarian cancer.

When ovarian cancer is found in its early stages, treatment is most effective and the chances for recovery are greatest. But ovarian cancer is difficult to detect early — there is no simple and reliable way to screen for this disease, symptoms are often not clear until later stages, and most women are diagnosed without being at high risk. That is why it is important for all women to pay attention to their bodies and know what is normal for them. Women who experience unexplained changes — including abdominal pain, pressure, and swelling — should talk with their health care provider. To learn more about the risk factors and symptoms of ovarian cancer, Americans can visit www.Cancer.gov.

Regular health checkups increase the chance of early detection, and the Affordable Care Act expands this critical care to millions of women. Insurance companies are now required to cover well-woman visits, which provide women an opportunity to talk with their health care provider, and insurers are prohibited from charging a copayment for this service.

For the thousands of women affected by ovarian cancer, the Affordable Care Act also prohibits insurance companies from denying coverage due to a pre-existing condition, such as cancer or a family history of cancer; prevents insurers from denying participation in an approved clinical trial for any life-threatening disease; and eliminates annual and lifetime dollar limits on coverage. And as we work to ease the burden of ovarian cancer for today’s patients, my Administration continues to invest in the critical research that will lead to earlier detection, improved care, and the medical breakthroughs of tomorrow.

Ovarian cancer and the hardship it brings have affected too many lives. This month, our Nation stands with everyone who has been touched by this disease, and we recognize all those committed to advancing the fight against this cancer through research, advocacy, and quality care. Together, let us renew our commitment to reducing the impact of ovarian cancer and to a future free from cancer in all its forms.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim September 2014 as National Ovarian Cancer Awareness Month. I call upon citizens, government agencies, organizations, health care providers, and research institutions to raise ovarian cancer awareness and continue helping Americans live longer, healthier lives. I also urge women across our country to talk to their health care providers and learn more about this disease.

IN WITNESS WHEREOF, I have hereunto set my hand this twenty-ninth day of August, in the year of our Lord two thousand fourteen, and of the Independence of the United States of America the two hundred and thirty-ninth.

BARACK OBAMA

__________________________________________________________

Sources:

• Cancer Facts & Figures 2014. Atlanta: American Cancer Society; 2014 [PDF file].

• Presidential Proclamation — National Ovarian Cancer Awareness Month, 2013, Office of the Press Secretary, The White House, August 29, 2014.

U.S. President Barack Obama Proclaims September 2013 As National Ovarian Cancer Awareness Month — What Should You Know?

Yesterday, U.S. President Barack Obama designated September 2013 as National Ovarian Cancer Awareness Month. “… During National Ovarian Cancer Awareness Month, we lend our support to everyone touched by this disease, we remember those we have lost, and we strengthen our resolve to better prevent, detect, treat, and ultimately defeat ovarian cancer…. This month, we extend a hand to all women battling ovarian cancer. We pledge our support to them, to their families, and to the goal of defeating this disease. …”

Yesterday, U.S. President Barack Obama designated September 2013 as National Ovarian Cancer Awareness Month. The Presidential Proclamation is reproduced in full below.

During National Ovarian Cancer Awareness Month, Libby’s H*O*P*E*™ will honor the women who have lost their lives to the disease, support those who are currently battling the disease, and celebrate with those who have beaten the disease. This month, medical doctors, research scientists, and ovarian cancer advocates renew their commitment to develop a reliable early screening test, improve current treatments, discover new groundbreaking therapies, and ultimately, defeat the most lethal gynecologic cancer.

Let us begin this month with several important facts relating to ovarian cancer. Please take time to review these facts — they may save your life or that of a loved one.

Ovarian Cancer Facts

Lethality. Ovarian cancer causes more deaths than any other cancer of the female reproductive system.

Statistics. In 2013, the American Cancer Society (ACS) estimates that there will be approximately 22,240 new ovarian cancer cases diagnosed in the U.S. ACS estimates that 14,030 U.S. women will die from the disease, or about 38 women per day or 1-to-2 women every hour. This loss of life is equivalent to 28 Boeing 747 jumbo jet crashes with no survivors — every year.

Signs & Symptoms. Ovarian cancer is not a “silent” disease; it is a “subtle” disease. Recent studies indicate that women with ovarian cancer are more like to experience four persistent, nonspecific symptoms as compared with women in the general population, such as (i) bloating, (ii) pelvic or abdominal pain, (iii) difficulty eating or feeling full quickly, or (iv) urinary urgency or frequency. Women who experience such symptoms daily for more than a few weeks should seek prompt medical evaluation. Note: Several other symptoms have been commonly reported by women with ovarian cancer. These symptoms include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities. However, these additional symptoms are not as useful in identifying ovarian cancer because they are also found in equal frequency in women within the general population who do not have the disease.

Age. Although the median age of a woman with ovarian cancer at initial diagnosis is 63, the disease cancer can afflict adolescent, young adult, and mature women. Ovarian cancer does not discriminate based upon age.

Prevention. Pregnancy, breastfeeding, long-term use of oral contraceptives, and tubal ligation reduce the risk of developing ovarian cancer.

Risk Factors.

• BRCA Gene Mutations. Women who have had breast cancer, or who have a family history of breast cancer or ovarian cancer may have increased risk. Women who test positive for inherited mutations in the BRCA-1 or BRCA-2 gene have an increased lifetime risk of breast and ovarian cancer. A women can inherit a mutated BRCA gene from her mother or father. Women of Ashkenazi (Eastern European) Jewish ancestry are at higher risk (1 out of 40) for inherited BRCA gene mutations. Studies suggest that preventive surgery to remove the ovaries and fallopian tubes in women possessing BRCA gene mutations can decrease the risk of ovarian cancer.

• Lynch Syndrome. An inherited genetic condition called “hereditary nonpolyposis colorectal cancer” (also called “Lynch syndrome“), which significantly increases the risk of colon/rectal cancer (and also increases the risk of other types of cancers such as endometrial (uterine), stomach, breast, small bowel (intestinal), pancreatic, urinary tract, liver, kidney, and bile duct cancers), also increases ovarian cancer risk.

• Hormone Therapy. The use of estrogen alone menopausal hormone therapy may increase ovarian cancer risk. The longer estrogen alone replacement therapy is used, the greater the risk may be. The increased risk is less certain for women taking both estrogen and progesterone, although a large 2009 Danish study involving over 900,000 women suggests that combination hormone therapy may increase risk. Because some health benefits have been identified with hormone replacement therapy, a women should seek her doctor’s advice regarding risk verses benefit based on her specific factual case.

• Smoking. Smoking has been linked to an increase in mucinous epithelial ovarian cancer.

Early Detection. There is no reliable screening test for the detection of early stage ovarian cancer. Pelvic examination only occasionally detects ovarian cancer, generally when the disease is advanced. A Pap smear cannot detect ovarian cancer. However, the combination of a thorough pelvic exam, transvaginal ultrasound, and a blood test for the tumor marker CA-125 may be offered to women who are at high risk of ovarian cancer and to women who have persistent, unexplained symptoms like those listed above. This early detection strategy has shown promise in a 2013 University of Texas M.D. Anderson Cancer Center early detection study involving over 4,000 women. Importantly, another large ovarian cancer screening trial that is using similar early detection methods is under way in the United Kingdom, with results expected in 2015. The U.K. study is called “UKCTOCS” (UK Collaborative Trial of Ovarian Cancer Screening) and involves over 200,000 women aged 50-74 years.

Treatment.

• Treatment includes surgery and usually chemotherapy.

• Surgery usually includes removal of one or both ovaries and fallopian tubes (salpingo-oophorectomy), the uterus (hysterectomy), and the omentum (fatty tissue attached to some of the organs in the belly), along with biopsies of the peritoneum (lining of the abdominal cavity) and peritoneal cavity fluid.

• In younger women with very early stage tumors who wish to have children, removal of only the involved ovary and fallopian tube may be possible.

• Among patients with early ovarian cancer, complete surgical staging has been associated with better outcomes.

• For women with advanced disease, surgically removing all abdominal metastases larger than one centimeter (debulking) enhances the effect of chemotherapy and helps improve survival.

• For women with stage III ovarian cancer that has been optimally debulked, studies have shown that chemotherapy administered both intravenously and directly into the abdomen (intraperitoneally) improves survival.

• Studies have also found that ovarian cancer patients whose surgeries are performed by a board-certified gynecologic oncologist at a high quality/high surgical volume medical facility have more successful outcomes. Such medical facilities include National Cancer Institute-Designated Cancer Centers and member institutions of the National Comprehensive Cancer Network.

• Patients can enter clinical trials at the start of, during the course of, and even after, their ovarian cancer treatment(s).

• New types of treatment are being tested in ovarian and solid tumor clinical trials, including “biological therapy” and “targeted therapy.” For example, these types of treatment can exploit biological/molecular characteristics unique to an ovarian cancer patient’s specific tumor classification, or better “train” the patient’s own immune system to identify and attack her tumor cells, without harming normal cells.

Survival. 

• If diagnosed at the localized stage, the 5-year ovarian cancer survival rate is 92%; however, only about 15% of all cases are detected at an early stage, usually fortuitously during another medical procedure. The majority of cases (61%) are diagnosed at a distant or later stage of the disease.

• Overall, the 1-, 5-, and 10-year relative survival of ovarian cancer patients is 75%, 44%, and 34%, respectively.

• The 10-year relative survival rate for all disease stages combined is only 38%.

• Relative survival varies by age; women younger than 65 are twice as likely to survive 5 years (56%) following diagnosis as compared to women 65 and older (27%).

Help Spread the Word To “B-E-A-T” Ovarian Cancer

Please help us “B-E-A-T” ovarian cancer by spreading the word about the early warning signs & symptoms of the disease throughout the month of September.

B = bloating that is persistent and does not come and go

E = eating less and feeling fuller

A =abdominal or pelvic pain

T = trouble with urination (urgency or frequency)

Women who have these symptoms almost daily for more than a few weeks should see their doctor. Prompt medical evaluation may lead to detection at the earliest possible stage of the disease. As noted above, early stage diagnosis is associated with an improved prognosis.

__________________________________________________________

The White House

Office of the Press Secretary

For Immediate Release August 30, 2013

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

Each September, America calls attention to a deadly disease that affects thousands of women across our country. This year, over 22,000 women will develop ovarian cancer, and more than half that number of women will die of this disease. During National Ovarian Cancer Awareness Month, we lend our support to everyone touched by this disease, we remember those we have lost, and we strengthen our resolve to better prevent, detect, treat, and ultimately defeat ovarian cancer.

Because ovarian cancer often goes undetected until advanced stages, increasing awareness of risk factors is critical to fighting this disease. Chances of developing ovarian cancer are greater in women who are middle-aged or older, women with a family history of breast or ovarian cancer, and those who have had certain types of cancer in the past. I encourage all women, especially those at increased risk, to talk to their doctors. For more information, visit www.Cancer.gov.

My Administration is investing in research to improve our understanding of ovarian cancer and develop better methods for diagnosis and treatment. As we continue to implement the Affordable Care Act, women with ovarian cancer will receive increased access to health care options, protections, and benefits. Thanks to this law, insurance companies can no longer set lifetime dollar limits on coverage or cancel coverage because of errors on paperwork. By 2014, the health care law will ban insurers from setting restrictive annual caps on benefits and from charging women higher rates simply because of their gender. Additionally, insurance companies will be prohibited from denying coverage or charging higher premiums to patients with pre-existing conditions, including ovarian cancer.

This month, we extend a hand to all women battling ovarian cancer. We pledge our support to them, to their families, and to the goal of defeating this disease.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim September 2013 as National Ovarian Cancer Awareness Month. I call upon citizens, government agencies, organizations, health care providers, and research institutions to raise ovarian cancer awareness and continue helping Americans live longer, healthier lives. I also urge women across our country to talk to their health care providers and learn more about this disease.

IN WITNESS WHEREOF, I have hereunto set my hand this thirtieth day of August, in the year of our Lord two thousand thirteen, and of the Independence of the United States of America the two hundred and thirty-eighth.

BARACK OBAMA

__________________________________________________________

Sources:

• Cancer Facts & Figures 2013. Atlanta: American Cancer Society; 2013 [PDF file].

• Presidential Proclamation — National Ovarian Cancer Awareness Month, 2013, Office of the Press Secretary, The White House, August 30, 2013.

Can Talcum Powder Cause Ovarian Cancer?

“A coalition of public health experts, medical doctors and consumers organizations is petitioning the U.S. Department of Health and Human Services and the Food and Drug Administration for labels on talcum powder products warning that frequent use is linked to ovarian cancer.

The petition addresses Secretary of Health and Human Services Mike Leavitt, and Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., a former director of the National Cancer Institute.

The group seeks labels with a warning such as, ‘Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer,’ on all cosmetic talcum products. The petition also seeks a public hearing at which evidence can be presented that the genital application of talc can result in its translocation to the ovary.

The Citizen Petition is submitted on behalf of: Samuel S. Epstein, M.D., Chairman, Cancer Prevention Coalition (CPC), and Professor emeritus Occupational and Environmental Medicine, University of Illinois at Chicago School of Public Health; Peter Orris, M.D., Professor and Chief of Service, University of Illinois at Chicago Medical Center; Quentin Young, M.D., Chairman, Health and Medicine Policy Research Group, Chicago; Rosalie Bertell, Ph.D., International Association for Humanitarian Medicine, Scientific Advisor to the International Institute of Concern for Public Health, Toronto, and the International Science Oversight Board of the Organic Consumers Association, Washington, D.C.; and Ronnie Cummins, National Director of the Organic Consumers Association.

This is not the first petition seeking such warning labels. On November 17, 1994, the Cancer Prevention Coalition and the New York Center for Constitutional Right submitted a Citizen Petition to the Commissioner of the FDA, “Seeking Carcinogenic Labeling on all Cosmetic Talc Products.”

The scientific basis of the 1994 Petition was admitted by the industry. In an August 12, 1982, article in the New York Times, Johnson & Johnson, the manufacturer and retailer of talc dusting powder, stated it was aware of a publication which concluded that frequent genital application of talc was responsible for a three-fold increased risk of ovarian cancer.

_______________________________________________________________________________________

PETITION SEEKING A CANCER WARNING ON COSMETIC TALC PRODUCTS

May 13, 2008

Mike Leavitt
Secretary of Health and Human Services
U.S. Department of Health and Human Services

Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs

Dockets Management Branch
Food and Drug Administration, Room 1601
5630 Fishers Lane
Rockville, MD 20852

This Petition, submitted under 21 U.S.C. 321 (n), 361, 362, and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug and Cosmetic Act, requests the Commissioner of Food and Drugs to require that all cosmetic talc products bear labels with a warning such as, “Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer.”

A. AGENCY ACTION REQUESTED

This Petition requests FDA to take the following action:
(1) Immediately require cosmetic talcum powder products to bear labels with a prominent warning such as: “Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.”

(2) Pursuant to 21 CFR 10.30 (h) (2), a hearing which will be held at which time we can present scientific evidence in support of this Petition.

B. STATEMENT OF GROUNDS
On November 17, 1994, the Cancer Prevention Coalition and the New York Center for Constitutional Rights submitted a Citizen Petition to the Commissioner of the FDA, “Seeking Carcinogenic Labeling on all Cosmetic Talc Products.”

The Petition was endorsed by Quentin Young, M.D., Chairman of The Health and Medicine Policy Research Group, Peter Orris, M.D., Director of Health Hazard Evaluation, Cook County Hospital, and Professor of Medicine, University of Illinois Medical School, Chicago, Nancy Nelson, Chair of the Ovarian Cancer Early Detection and Prevention Foundation, and subsequently by Senator Edward Kennedy. In a 1997 statement to the Senate, he requested the FDA to place a cancer warning on the label of talc products, besides other products containing known carcinogens. However, over a decade later his warning remains ignored.

The 1994 Petition was supported by 15 scientific publications. These included nine, from 1983 to 1992, on the major risks of ovarian cancer from the frequent application of brand or generic talc “baby powder” to the genital area of women without any warning of the risks involved. Two of these publications also reported that the genital application of talc could result in its translocation to the ovary.

The scientific basis of the 1994 Petition was further supported by J. Mande, Acting Associate Commissioner for Legislative Affairs of the Department of Health and Human Services. On August 25, 1993, he admitted that “We are aware that there have been reports in the medical literature between frequent direct female perineal talc dusting over a protracted period of years, and an incremental increase in the statistical odds of subsequent development of certain ovarian cancers … (However) at the present time, the FDA is not considering to ban, restrict or require a warning statement on the label of talc containing products.”

The scientific basis of the 1994 Petition was also admitted by the industry. In an August 12, 1982, article in the New York Times, Johnson & Johnson, the manufacturer and retailer of talc dusting powder, stated it was aware of a publication which concluded that frequent genital application of talc was responsible for a three-fold increased risk of ovarian cancer.

Warnings of these risks were emphasized by the Cancer Prevention Coalition in November 19, 1994, in letters to Mr. Ralph Larsen, CEO of Johnson & Johnson, and Mr. C.R. Walgreen, Chairman and CEO of Walgreens. Johnson & Johnson was urged to substitute cornstarch, a safe organic carbohydrate, for talcum powder products, and also to label its products with a warning on cancer risks.

In spite of the scientific evidence, and admission by Johnson & Johnson, the Petition was denied by Dr. John Bailey, FDA’s Director of the Office of Cosmetics and Colors, on the basis of the “limited availability” (of Agency resources) and on alleged scientific grounds. Dr. Bailey is currently Director of the industry’s Personal Care Products Council.

Evidence for the May 2008 Petition is supported by Edward Kavanaugh, President of the industry’s Cosmetic Toiletry and Fragrance Association. In 2002, he admitted that talc is “toxic,” that it “can reach the human ovaries,” and that prior epidemiological investigations concluded that its genital application increased the risk of ovarian cancer.

Further evidence for this Petition is based on 12 publications since 1995, cited below. These confirm the causal relation between genital application of talc and ovarian cancer, and the protective effect of tubal ligation or hysterectomy, preventing the translocation of talc to the ovary.

As Dr. Andrew C. von Eschenbach, former Director of the National Cancer Institute, is aware, the mortality of ovarian cancer for women over the age of 65, has escalated dramatically since 1975, by 13% for white and 47% for black women (1). There are about 15,300 deaths from ovarian cancer each year. This makes it the fourth most common fatal cancer in women after colon, breast and lung.

A case-control study, the largest to date, confirmed the relation between the perineal use of talc and ovarian cancer (2). This has also been confirmed by other reports (3-7). In view of the strength of this evidence, “formal public health warnings” were urged in 1999 (8).

An analysis of 16 pooled studies confirmed a statistically significant 33% increased risk of ovarian cancer associated with the perineal use of talc (9). A report by 19 scientists in eight nations worldwide, under the auspices of the International Agency for Research on Cancer, concluded that eight publications confirmed a 30-60% increased risk of ovarian cancer following the perineal application of talc (10). This risk has been confirmed in other reports (11, 12).

The protective effects of tubal ligation or hysterectomy, preventing the translocation of talc from the perineum to the ovary, have also been confirmed (2, 3, 4, 7).

C. CLAIM FOR CATEGORICAL EXCLUSION
A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24 (a) (11).

D. CERTIFICATION
The undersigned certifies, that, to his best knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

This petition is submitted by:
Samuel S. Epstein, M.D.
Chairman, Cancer Prevention Coalition
Professor emeritus Occupational and Environmental Medicine
University of Illinois School of Public Health, Chicago

REFERENCES
1. National Cancer Institute. SEER Cancer Statistics Review, 2005 (posted 2008).

2. Purdie D, et al. Reproductive and other factors and risk of epithelial ovarian cancer: an Australian case-control study. Survey of Women’s Health Study Group. Int J Cancer Sep 15;62(6):678-684, 1995.

3. Kasper CS & Chandler PJ Jr. Possible morbidity in women from talc on condoms [letter]. JAMA March 15;273(11):846-847, 1995.

4. Cramer DW & Xu H. Epidemiologic evidence for uterine growth factors in the pathogenesis of ovarian cancer. Ann Epidemiol July;5(4):310-314, 1995.

5. Chang S & Risch HA. Perineal talc exposure and risk of ovarian carcinoma. Cancer June 15; 79(12):2396-2401, 1997.

6. Daly M & Obrams GI. Epidemiology and risk assessment for ovarian cancer. Semin Oncol June 25(3):255-264, 1998.

7. Green A, et al. Tubal sterilisation, hysterectomy and decreased risk of ovarian cancer. Survey of Women’s Health Study Group. Int J Cancer June 11;71(6):948-951, 1997.

8. Cramer DW, et al. Genital talc exposure and risk of ovarian cancer. Int J Cancer May 5;81(3):351-356, 1999.

9. Huncharek M, et al. Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: a meta-analysis of 11,933 subjects from sixteen observational studies. Anticancer Res Mar-Apr;23(2C):1955-1960, 2003.

10. Baan R, et al. Carcinogenicity of carbon black, titanium dioxide, and talc. The Lancet Oncology April vol 7:295-296, 2006.

11. Langseth H, et al. Perineal use of talc and risk of ovarian cancer. J Epidemiol Community Health April 62(4):358-360, 2008.

12. Merritt MA, et al. Talcum powder, chronic pelvic inflammation and NSAIDS in relation to risk of epithelial ovarian cancer. Int J Cancer 122:170-176, 2008.

CONTACT:
Samuel S. Epstein, M.D.
UIC School of Public Health
MC 922 – 2121 W. Taylor St.
Chicago, IL 60612
312-996-2297
epstein@uic.edu
Chairman Cancer Prevention Coalition
http://www.preventcancer.com”

[Quoted Source: Petition Seeks a Cancer Warning on Cosmetic Talc Products, World Wire Press Release dated May 15, 2008.]

Additional Resources (including contrarian views):

• Talcum Powder and Cancer, American Cancer Society, January 31, 2006.
• Perineal talc use and ovarian cancer: a critical review, Muscat, J.E. et. al, Eur J Cancer Prev. 2008 Apr;17(2):139-46.
• Talcum powder, chronic pelvic inflammation and NSAIDs in relation to risk of epithelial ovarian cancer, Merritt, M.A. et. al., Int J Cancer. 2008 Jan 1;122(1):170-6.
• Presence of talc in pelvic lymph nodes of a woman with ovarian cancer and long-term genital exposure to cosmetic talc, Cramer, D.W. et. al, Obstet Gynecol. 2007 Aug;110(2 Pt 2):498-501.
• Perineal talc exposure and epithelial ovarian cancer risk in the Central Valley of California, Mills, P.K. et. al., Int J Cancer. 2004 Nov 10;112(3):458-64.

Comment: Until additional information is available about the safety of talc use, women who use talcum powder may wish to consider avoiding these products or substituting cornstarch-based powders that contain no talc. There is no evidence at present linking cornstarch powders with any form of cancer.

Take The “Check-Up Day Pledge” and Register For the “Woman Challenge” During Women’s National Health Week

” …Women are often the caregivers for their spouses, children and parents and forget to focus on their own health. But research shows that when women take care of themselves, the health of their family improves. …”

National Women’s Health Week empowers women across the country to get healthy by taking action. The nationwide initiative, coordinated by the U.S. Department of Health and Human Services‘ Office on Women’s Health (OWH), encourages women to make their health a top priority and take simple steps for a longer, healthier and happier life. During the week, families, communities, businesses, government, health organizations and other groups work together to educate women about steps they can take to improve their physical and mental health and prevent disease, like:

* Engaging in physical activity most days of the week;

* Eating a nutritious diet;

* Visiting a healthcare provider to receive regular check-ups and preventive screenings; and

* Avoiding risky behaviors, like smoking and not wearing a seatbelt.

It is important to celebrate National Women’s Health Week to remind women that taking care of themselves is essential to living longer, healthier and happier lives. Women are often the caregivers for their spouses, children and parents and forget to focus on their own health. But research shows that when women take care of themselves, the health of their family improves. During National Women’s Health Week it is important to educate our wives, mothers, grandmothers, daughters, sisters, aunts and girlfriends about the steps they can take to improve their health and prevent disease. After all, when women take even the simplest steps to improve their health, the results can be significant and everyone will benefit. The 9th Annual National Women’s Health Week began on Mother’s Day, May 11, 2008 and will be celebrated until May 17, 2008.

National Women’s Check-Up Day is a nationwide effort, coordinated by the U.S. Department of Health and Human Services’ Office on Women’s Health, to:

* Encourage women to visit health care professionals to receive or schedule a check-up; and
* Promote regular check-ups as vital to the early detection of heart disease, diabetes, cancer, mental health illnesses, sexually transmitted diseases, and other conditions.

As part of National Women’s Check-Up Day, the U.S. Department of Health and Human Services, Agency for HealthCare Research and Quality, provides a health checklist entitled, “Women: Stay Healthy At Any Age, Your Health Checklist.” Top health experts from the U.S. Preventive Services Task Force suggest that when you go for your next checkup, you should use the health checklist and talk to your doctor or nurse about how you can stay healthy regardless of age.

The WOMAN Challenge, a free eight week challenge encouraging women and girls (ages 9 and older) to walk 10,000 steps a day or get 30 minutes of moderate exercise daily. Team participation is highly encouraged, so create a team with your friends, family or coworkers. The WOMAN Challenge is a great way to get the exercise you need while having fun and staying motivated. It begins on Mother’s Day, May 11, and ends on July 5, 2008.

Click Here to Take the “Check-Up Day Pledge”

Click Here to Register for the “Women Challenge”

Derivative Vitamin A Compound Prevents Ovarian Cancer In the Lab

” …The compound, which still faces several rounds of clinical trials, successfully stopped normal cells from turning into cancer cells and inhibited the ability of tumors to grow and form blood vessels. If successful tests continue, researchers eventually hope to create a daily pill that would be taken as a cancer preventive. …”

“While researching new ways to stop the progression of cancer, researchers at the University of Oklahoma Health Sciences Center, have discovered a compound that has shown to prevent cancer in the laboratory. The compound, which still faces several rounds of clinical trials, successfully stopped normal cells from turning into cancer cells and inhibited the ability of tumors to grow and form blood vessels. If successful tests continue, researchers eventually hope to create a daily pill that would be taken as a cancer preventive. ‘This compound was effective against the 12 types of cancers that it was tested on,’ said Doris Benbrook, Ph.D., principle investigator and researcher at the OU Cancer Institute. ‘Even more promising for health care is that it prevents the transformation of normal cells into cancer cells and is therefore now being developed by the National Cancer Institute as a cancer prevention drug.’

The synthetic compound, SHetA2, a Flex-Het drug, directly targets abnormalities in cancer cell components without damaging normal cells. The disruption causes cancer cells to die and keeps tumors from forming. Flex-Hets or flexible heteroarotinoids are synthetic compounds that can change certain parts of a cell and affect its growth. Among the diseases and conditions being studied for treatment with Flex-Hets are polycystic kidney disease, kidney cancer and ovarian cancer. Benbrook and her research team have patented the Flex-Het discovery and hope to start clinical trials for the compound within 5 years. If the compound is found to be safe, it would be developed into a pill to be taken daily like a multi-vitamin to prevent cancer.

The compound also could be used to prevent cancer from returning after traditional radiation and chemotherapy treatments, especially in cancers that are caught in later stages such as ovarian cancer where life expectancy can be as short as 6 months after treatment. ‘It would be a significant advancement in health care if this pill is effective in preventing cancer, and we could avoid the severe toxicity and suffering that late stage cancer patients have to experience,’ Benbrook said.”

[Quoted Source: “Chemical Compound Prevents Cancer In Lab,” Science News, ScienceDaily, May 14, 2008].

Additional Information: The foundational in vivo study performed by Benbrook et. al. involving use of various retinoids, including SHetA2, against ovarian cancer is entitled, Effects of Retinoids on Cancerous Phenotype and Apoptosis in Organotypic Cultures of Ovarian Carcinoma, Benbrook, D. et. al; Journal of the National Cancer Institute, Vol. 93, No. 7, 516-525, April 4, 2001. Click here for full text Adobe PDF copy.

Jewish Women Change Their Destinies by Testing for Genetic Mutation

“One in 40 Ashkenazi Jews – compared to one in 500 in the general population – carries a mutation that gives women a 50 percent to 85 percent chance of getting breast cancer by the time they are 80. The genetic mutation, discovered in 1994, also increases the likelihood of melanoma and ovarian, prostate or pancreatic cancer. While within the general population about 5 percent of cancers can be attributed to a hereditary syndrome, in the Jewish community, that number is closer to 30 percent. ”

“Erika Taylor didn’t want to know whether she had the breast cancer gene.

‘My thinking was I would never get a prophylactic mastectomy,’ Taylor, 44, said of the idea of removing her breasts as a preventive measure. ‘I just thought it was horrible thing to do to myself, and if I was unwilling to do that, why bother finding out?’

Her grandmother died of breast cancer at 56, and her mother battled and beat the disease in her 30s. Taylor, who is single and the mother of a 14-year-old boy, always suspected cancer was in her future, but taking steps to confirm that was not something she wanted to do. Until she got her own diagnosis.

A routine mammogram last November revealed early stage noninvasive cancer cells in Taylor’s milk ducts, making information about her genetic status vital for determining her treatment.

All of a sudden, the idea of ‘I would never do such a thing’ goes out the window,’ she said. ‘It’s astonishing how quickly you go, ‘OK, OK, what do I need to do? I’ll do it.” Taylor’s mother tested first, and when she was identified as a carrier of the BRCA 2 genetic mutation common in Ashkenazi Jews, Taylor tested next. In January, she found out she, too, carries the gene that makes it likely that even if she were to rid herself of her diagnosed cancer, it would probably recur.

Like a growing number of women, Taylor faced both the gift and the terror of knowledge.

One in 40 Ashkenazi Jews – compared to one in 500 in the general population – carries a mutation that gives women a 50 percent to 85 percent chance of getting breast cancer by the time they are 80. The genetic mutation, discovered in 1994, also increases the likelihood of melanoma and ovarian, prostate or pancreatic cancer. While within the general population about 5 percent of cancers can be attributed to a hereditary syndrome, in the Jewish community, that number is closer to 30 percent.

The good news is that knowledge about how the mutation causes cancer is opening scientific doors to more effective, targeted treatment for those already diagnosed. And people who have the genetic mutation can take preventative measures to drastically reduce their breast and ovarian cancer risk.

Surgery – removal of the breasts and ovaries – reduces the risk of breast cancer by 90 percent, to well below the 13 percent odds of getting breast cancer in the general population. But less-drastic measures, such as drug therapy, removal of just the ovaries and careful screening to catch and cure the cancer at an early stage, can also save lives. Genetic information also helps women feel empowered to take control of other factors that raise risk, such as smoking, alcohol consumption and obesity.

‘The use of genetic information to understand a person’s risk for diseases like cancer is clearly reaping huge benefits,’ said Dr. William Audeh, a medical oncologist with an emphasis on hereditary risk at Cedars-Sinai Medical Center‘s Samuel Oschin Comprehensive Cancer Institute. ‘It’s gone from being a somewhat frightening piece of information that gave people concerns to a hugely important piece of information that empowers people to either take preventative steps that can save their lives or to accurately target therapy if one develops cancer. There is a general understanding that genetic information for cancer is going to be critical for taking the best care of people.’

Knowing she had the genetic mutation sent Taylor, editor of the trade publication, Pool and Spa magazine, into a tailspin of research and soul-searching. Treatment for DCIS (ductal carcinoma in situ) usually consists of removal of the tumor and perhaps radiation. But Taylor’s genetic status put her in a different risk category, and after hearing from four different doctors that her cancer, even if cured, would return, she opted for a double mastectomy and reconstruction. Her surgery is scheduled for May.

Taking the test

While Taylor confirmed her genetic status after a cancer diagnosis, experts encourage people to test before cancer strikes. For Ashkenazi Jews, having just one relative who has had premenopausal breast cancer warrants getting tested, according to geneticists. (For non-Jews, testing is indicated if there are two relatives.) Any history of male breast cancer or any ovarian cancer in the family also raises a red flag, as do multiple cases of melanoma or pancreatic cancer. And women who themselves have early onset breast cancer should be tested, so they can tailor their treatment and inform other family members.

In the last five years, the number of people testing for the BRCA mutation has increased by 50 percent every year, according to Myriad Genetics, which patented the blood test for BRCA about 12 years ago. About 70,000 people tested last year. Myriad recently launched an East Coast direct-marketing campaign for the test.

Of the estimated 600,000 people who carry the gene in the United States, only about 20,000 have been identified. Of those 600,000 carriers, about 150,000 are Jewish, mostly Ashkenazi. Other ethnic groups, such as French Canadians and Filipinas, also have a genetic predisposition, as do some Latina subpopulations – some of which have been traced back to having Jewish genes.

Only about 15 percent of people who test come out with positive results, though the percentage is somewhat higher among Jews. But even a negative result is not entirely reassuring, since it indicates only that the specific mutations were not found. Other as-yet-undiscovered mutations, or other genes, could also cause a heavy incidence of cancer in a family, according to Dr. Ora Gordon, director of the GenRISK adult genetics program at Cedars.

Gordon encourages anyone being tested to see a genetic counselor to get the results properly interpreted and to understand their options if they find out they are carriers.

‘When learning about this for the first time, very frequently people say to themselves, If I’m not going to have surgery, I shouldn’t get this test.” Gordon said. ‘But that would be a tremendous loss in terms of potential reassurance for people who are not carriers and for identifying people who might have a whole variety of other options that might provide very substantial risk reduction.’

Prophylactic bilateral mastectomy – or having both breasts removed before any sign of cancer – seems to be growing in popularity as an option in the United States, though hard statistics are just now being compiled.

One recent study of women with the BRCA mutation and a cancer diagnosis put the rate of mastectomy at 50 percent in the United States, the highest by far of anywhere in the world. In Israel, that number is 2 percent, Gordon said.

In Los Angeles in particular, the numbers seem to be especially high.

Gordon estimates that 65 percent to 70 percent of BRCA-positive women in Cedars’ cancer programs opt for the surgery, some immediately, some after a few years of surveillance. ‘The quantity and quality of medical options makes the surgery more attractive in big cities, and Los Angeles has a high tolerance for breast surgery,’ Gordon said. She is spearheading a study about decision-making among BRCA-positive women at Cedars’ Gilda Radner early detection program, which screens genetically high-risk women for ovarian cancer.

Gordon understands that a woman’s decision about treatment is intertwined with her relationship status, her self-image and how many family members she saw battle or succumb to cancer.

Surgery or surveillance?

‘The decision to take off your breasts is really hard. It’s a part of your body that is associated with your outward appearance, and it’s a part of who you are. It’s a part of your sex life,’ said Joi Morris, who was 41 when she learned she carried the same genetic mutation that gave her mother and grandmother breast cancer at a young age.

Morris remembers a day, not long after she found out, when she really confronted the issue as her sons, then 7 and 10, played at the beach.

‘My kids were in the water and jumping and playing and having a fabulous time, and I looked down at my breasts in my swimming suit and thought, “Oh my God, what would it be like to not have these?'” ‘It’s a seesaw of emotions,’ she said, because at the same time, ‘you wake up every morning, and you know you are at risk, and you wonder if there is something in there you can’t find.’

Morris initially opted for close surveillance – a regimen of regular mammograms, manual exams, ultrasounds and breast MRIs – the most sensitive, noninvasive screening available, used only for high-risk patients. Her first MRI revealed a lump close to her chest wall.

‘I panicked. There is no other way to put it. That lump turned out to be benign, but the whole process was so stressful for me and hard on my family. I just decided if this lump is not cancer, the next one could be,’ Morris said.

She had a prophylactic bilateral mastectomy, with immediate reconstruction. As it turned out, her surgery wasn’t prophylactic at all – pathology revealed pre-cancerous cells scattered throughout both breasts.

Early in the process, Morris turned for support and information to FORCE: Facing Our Risk for Cancer Empowered, an organization that advocates for people at high genetic risk for breast and ovarian cancer.

Today, she is an outreach coordinator for FORCE, helping link women through face-to-face groups and one-on-one pairings as they face life-altering decisions.

‘It was very hard getting those results,’ said Lisa Stein, a 43-year-old mother of two, who found out she has the gene last year. ‘I was trying to prepare for being positive, but I don’t think you ever can. After I got the results, I really struggled. I was feeling raw for a while, crying easily knowing that it was going to be life-changing.’

Stein’s mother died of breast cancer at 57, and her grandmother died of ovarian cancer, but she didn’t test until her older sister, Lauren Rothman, tested positive.

Rothman opted for a mastectomy, but Stein chose to keep her breasts.

‘I think I knew instinctively that I was not going to have a double mastectomy. That felt too radical to me,’ Stein said. ‘I didn’t feel psychologically prepared or that it was necessary. I don’t feel like cancer is imminent; I feel like I have a few years to take it in and think about it and prepare, so I’ve put that decision on hold.’

She goes in for screening every few months, and she said the anxiety of waiting for those results has been manageable.

Both Rothman and Stein had their ovaries removed, however, which doctors are now recommending for women who test positive and who are finished having children or who are over age 35. Removing ovaries not only reduces the risk of ovarian cancer – which is notoriously hard to catch early and thus has a high mortality rate – but it reduces the risk of breast cancer by 50 percent. Stein also went on Tamoxifen, a drug taken by breast cancer survivors to reduce the risk of recurrence and which reduces risk by 50 percent in BRCA-positive women. The birth control pill, which stops the ovaries from cycling, can also reduce the risk of ovarian cancer but requires more vigilant screening for breast cancer.

Both ovary removal and Tamoxifen push women into menopause, with all its emotional, sexual and physiological ramifications.

‘I think of myself as a healthy person but not like I used to – it’s kind of tainted,’ Stein said. ‘It’s an identity issue. I still think of myself as youthful, but suddenly, I’m dealing with instant menopause, and that doesn’t sit well with me. But I’m dealing with it.’

Stein and Rothman provide support for each other, despite the different routes they’ve taken.

‘I came to reality very quickly – and the reality was I wanted to see my children grow up, and I didn’t want cancer, and I didn’t want chemotherapy. I wanted the rest of my life,’ Rothman said. Her daughters were 3 and 5 years old when she had surgery.

Rothman, a program director for Hadassah of Southern California, traveled to New Orleans for her breast procedure – two surgeries and tatoooing – at a small clinic that specializes in natural-tissue reconstruction, where a solid flap of fat is removed from the belly and inserted into the shell of the breast after tissue has been removed. The surgery offers a more natural result than silicone implants, though it is longer and more involved.

‘This procedure has provided me with a new outlook on life. It has taken a huge weight off my shoulder,’ Rothman said. ‘I no longer go into mammograms thinking, “Is this the year I’m going to get cancer like mom?'”

And she loves her new body – she got not only a breast lift but a bonus tummy tuck, too.

Advances in reconstructive techniques mean that women have several options for maintaining a body they can feel proud of.

Decades ago, radical mastectomies removed all the tissue and muscle of the chest wall. Today, the muscle is not removed, and reconstructive surgery, usually at the time of mastectomy, can leave intact the women’s natural skin, but in most cases the nipples and areola are removed. A silicone implant, or, as in Rothman’s case, fat from the abdomen, fills the pocket from which breast tissue was removed. Nipples and areola are tattooed on, or some surgeons use a new technique that leaves a woman’s own nipple and areola intact. Doctors try to bury scars in the fold beneath the breast, though that is not always possible.

But even the most beautifully done reconstructions leave a woman with scars and no sensation in her breasts.

‘When women come to see me, my approach is to listen to them and find out where they are in life and how they relate to their own breasts,’ said Dr. Kristi Funk, a breast surgeon and director of patient education at Cedars’ Brandman Breast Center. ‘Women have different feelings about sexuality and what roles breasts play, and that makes a big difference.’

Funk also finds out about the woman’s relationship status, and how she has been affected by a family history of cancer.

More information, better treatment

Family histories can be deceptive, however. Some families don’t know their medical histories, because they were lost due to the Holocaust or immigration.

The gene also can hide out in male members of a family.

A BRCA 1 gene mutation raises the risk of male breast cancer to 6 percent, and there is no increased risk for other cancers. BRCA 2 mutation also increases the risk for melanoma, prostate and pancreatic cancer. Still, men who carry the gene are likely never to get any cancer, although they have a 50 percent chance of passing the gene to children. Families with few females may never discern any cancer history.

Dora Cohen (not her real name) suspects it was her father who passed the BRCA 1 gene mutation to her. Last year, she was diagnosed with DCIS, a noninvasive cancer, which was treated with a lumpectomy and radiation. Of the many oncologists she saw, only one recommended that as an Ashkenazi woman in her 40s, she probably should have genetic testing.

In the last six months, Dora has had her ovaries, uterus and breasts removed.

Her daughter, Diane (not her real name), who is 27 and has been married for two years, doesn’t want to get tested yet.

‘I see what my mom is going through,’ Diane said. ‘I want to have kids, and I’m not in a place where I would take those measures [mastectomy and removal of the ovaries]. Knowing I’m positive and having that pressure on me would be something very difficult to live with.’

She and her husband of two years have pushed up their plans for children, and she worries that a positive test could jeopardize her medical insurance, especially because she is self-employed.

Federal and California law provide fairly good protection against genetic discrimination from insurers, stipulating that a genetic predisposition cannot be considered a pre-existing condition. But individual policies are not as well protected as group policies.

Still, genetics experts say much of the fear is overblown. They point out that there has been little litigation involving genetic discrimination, and that the insurance industry is open to the reality that genetic testing can lead to better and more cost-effective treatment. Most insurers cover genetic testing, and some genetic counseling – a rapidly growing field.

‘The genetics community has been struggling to help people understand the importance of talking to someone who knows the nuances of genetic testing,’ said Heather Shappell, a genetic counselor and founder of Informed Medical Decisions, which offers over-the-phone genetic counseling.

‘Genetic tests do not always yield a yes-or-no answer,’ Shappell said, ‘and often doctors aren’t sure how to read the results and guide patients through their decisions.’

In August, Aetna extended full coverage for Shappell’s phone-counseling services to its 14 million policyholders.

What geneticists are looking for is an error in the sequencing of the BRCA gene.

All people carry two genes, BRCA 1 and BRCA 2, which prevent cancer by repairing damaged cells. A mutation damages the genes’ repair function, which leads to uncontrolled growth and causes cells to become cancerous.

About 95 percent of Ashkenazi Jews who have the mutation have one of three errors, which means the mutation is easier to find and the test costs much less – about $400, as compared to $3,000 for a test that analyzes the entire gene.

As researchers learn more about how BRCA mutations cause cancer, they are developing targeted treatments.

A clinical trial with sites at Cedars and City of Hope uses a drug called a PARP-inhibitor to shut down the cell’s backup repair function. Normal cells are not affected, because the primary repair pathway is still functioning. But cancerous cells are left with no functioning repair system, so those cells die. Because normal cells are not affected, there are few major side effects.

‘We have a promising situation where you have a treatment which is completely targeted to cancer and leaves the normal cells alone. And that is very different from treatments like chemotherapy, where there is toxicity to every cell,’ said Audeh of Cedars.

Another study in Israel has found that women with ovarian cancer who are BRCA positive respond better to chemotherapy and have a higher survival rate than women who are not carriers, according to Jeff Weitzel at City of Hope. Weitzel, an investigator in the PARP-inhibitor trial, is also working on a study that manipulates hormones to reduce breast density, which makes surveillance through mammography and ultrasound more effective.

In February, the Jerusalem Post reported that doctors for an Orthodox woman undergoing in-vitro fertilization at Hadassah Hospital were able to identify and screen out embryos that had inherited her BRCA mutation. [Jerusalem Post Feb. 2008 article abstract]

A gift of life?

But while such progressive procedures have been generally well received in Israel, there is still social reluctance to test for the gene, especially in traditional circles, where families fear a genetic flaw could hurt the marriageability of their kids.

Debra Nussbaum Stepen, a Los Angeles therapist who now lives in Israel, is trying to break those perceptions. She works as a therapist at a clinic for hereditary breast and ovarian cancer, and she volunteers for Bracha, a Hebrew-language Web site for BRCA carriers.

The name of the site – bracha means blessing and is a play on BRCA – connotes that knowing one’s genetic makeup is a blessing that can save one’s life.

It is a lesson Stepen learned personally.

Her father had several kinds of cancer, including breast cancer, and before he died at 77, Debra urged him to get genetic testing. She was 51 and had never had cancer when she found out she carried the gene.

‘My doctor told me my breasts were ticking time bombs, and I couldn’t go to bed at night knowing that and thinking today am I going to get cancer?’ said Stepen, who has three stepchildren and a new stepgranddaughter.

She observed her father’s first yahrzeit in New Orleans, where she was undergoing the third and last part of a double mastectomy and reconstruction.

‘I said to my husband, in my father’s death he gave me the gift of life,’ Stepen said.

It takes time to reach this comfort level. As Erika Taylor prepares for her surgery in a few weeks, she worries about the ‘gift’ she may give to her son. She and her mom have talked about how irrational that guilt is.

‘I can say to my mom, “You didn’t know. It’s OK. It’s not your fault,’” she said. ‘But when it comes to me and my son, I think how could I have done this to my son. I am in abject horror that I might have passed this on to him. I know it’s irrational, but the whole idea fills me with grief.’

At the same time, she has hope.

‘My grandmother died from breast cancer at 56. My mother almost died of this disease. And I’m not going to even come close to dying,’ Taylor said. ‘My hope for my son, if he has this, is that he may not have to have any medical intervention at all. Maybe they can repair this mutation. The idea that there is trajectory moving in the right direction gives me some comfort and hope.’”

[Quoted Source: “Jewish women change their destinies by testing for genetic mutation,” by Julie Gruenbaum Fax (Jewish Journal of Greater Los Angeles), Texas Jewish Post, April 24, 2008 (emphasis added)]

Comment: For additional information relating to hereditary breast and ovarian cancer with respect to all women (Jewish and Non-Jewish), refer to the following: (i) FORCE: Facing Our Risk of Cancer Empowered; (ii) National Breast and Ovarian Cancer Coalition; (iii) “Clinical Considerations,” Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility Recommendation Statement, U.S. Preventive Services Task Force (USPSTF), Agency for Healthcare Research & Quality (AHRQ), U.S. Department of Health & Human Services, September 2005; (iv) “Genetics” hyperlinked materials, H*O*P*E* Blog homepage.