U.S. Food & Drug Administration Acts to Bolster Supply of Critically Needed Cancer Drugs Including Doxil

The U.S. Food and Drug Administration today announced a series of steps to (i) increase the supply of critically needed cancer drugs, and (ii) build upon President Obama’s Executive Order to help prevent future drug shortages.  To alleviate the Doxil cancer drug shortage, the FDA approved  the temporary importation of a replacement drug named “Lipodox” (doxorubicin hydrochloride liposome injection), with the expectation of  ending the U.S. shortage and fully meeting patient needs in the coming weeks. Doxil is an important weapon in the fight against recurrent ovarian cancer.

The U.S. Food and Drug Administration today announced a series of steps designed to increase the supply of critically needed cancer drugs, and build upon President Obama’s Executive Order, dated October 31, 2011 (No. 13588), in an attempt to prevent future drug shortages.

Margaret Hamburg, M.D., Commissioner, U.S. Food & Drug Administration

“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Margaret A. Hamburg, M.D. “Through the collaborative work of the FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

In response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) and rapidly declining supplies of methotrexate, the FDA took proactive steps needed to increase available supply for patients in the U.S.

For Doxil, there will be temporary importation of a replacement drug named “LipoDox” (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks.

For methotrexate, in addition to already announced actions, the FDA approved a new manufacturer of preservative-free formulation of methotrexate that is expected to further bolster supply and help avert a shortage of this lifesaving medicine. the FDA expedited review of the application to help address this potential shortage.

In response to President Obama’s Executive Order #13588 regarding prescription drug shortages, the FDA today issued draft guidance to industry which provides detailed requirements for both mandatory and voluntary notifications to the FDA of issues that could result in a drug shortage or supply disruption. Because of President Obama’s Executive Order #13588 and the FDA’s letter to manufacturers on the same day, increased awareness of the importance of early notification has resulted in a sixfold increase in voluntary notifications by industry of potential shortages. In 2011, there were a total of 195 drug shortages prevented. Since the issuance of Presidential Executive Order #13588, the FDA has prevented 114 drug shortages.

Under the FDA’s exercise of enforcement discretion, the chemotherapeutic drug LipoDox will be imported as an alternative to Doxil. Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy (e.g., carboplatin or cisplatin). The drug is also indicated for use in AIDS-related Kaposi’s sarcoma and multiple myeloma. The FDA anticipates that the incoming supply of LipoDox will be able to fully meet patient needs.

The FDA’s exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE (a United Arab Emirates entity) and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. (a U.S. subsidiary of Sun Pharmaceutical Industries Ltd., a leading Indian pharmaceutical company).

Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs.

When a company is identified that is willing and able to import the needed drug product, the FDA evaluates the foreign-approved drug to ensure that it is of adequate quality and that the drug does not pose significant risks for U.S. patients. Only after successful evaluation of these factors does the FDA exercise its enforcement discretion for the temporary importation of an overseas drug into the U.S. market.

Methotrexate is a drug that is needed for the treatment of many forms of cancer and other serious diseases. For example, preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with acute lymphocytic leukemia (ALL), as well as high-dose therapy of osteosarcoma.

To alleviate the shortage of methotrexate, the FDA has successfully engaged several firms to assist in maintaining supplies to meet all patient needs. First, the FDA has prioritized the review and approval of a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals (APP) and expects that product to become available in March 2012 and continue indefinitely. Second, Hospira expedited release of additional methotrexate supplies, resulting in 31,000 vials of new product – enough for more than one month’s worth of demand – being shipped to hundreds of U.S. hospitals and treatment centers today. The FDA is actively working with other manufacturers of methotrexate who have also stepped up to increase drug production for the purpose of meeting patient needs, including Mylan and Sandoz Pharmaceuticals.

APP’s application for preservative-free methotrexate is a supplement to its already approved generic drug application that the firm had previously discontinued. When the FDA became aware of potential problems with the supply of the drug (attributable to the voluntary plant closing of the largest methotrexate manufacturer, Ben Venue Laboratories), the agency reached out to other firms to see how the FDA could assist to meet the shortfall.

Prior to the approval of APP’s application, and the subsequent Ben Venue Laboratories’ voluntary shutdown, the FDA worked with Ben Venue on release of already manufactured preservative-free methotrexate, following its confirmation of the safety of remaining drug inventory. This supply is available already and will provide emergency supplies as the other firms also work to increase production of methotrexate in response to requests by the FDA and the public.

On October 31, 2011, the Obama Administration also announced its support for bipartisan legislation that would (i) require all prescription drug shortages to be reported to the FDA, and (ii) give the FDA new authority to enforce these requirements. While additional manufacturing capacity is necessary to fully address the drug shortage problem, additional early notification to the FDA can have a significant, positive impact on addressing the incidence and duration of drug shortages.

For more FDA information relating to the U.S. drug shortage, please click on the topics listed below:

Drug Shortages

Drug Shortage Guidance (“Guidance for Industry — Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage – Draft Guidance,” dated February 2012)

Labeling for Doxil (doxorubicin hydrochloride liposome injection)

Letter from Sun Pharma Global FZE to healthcare professionals regarding doxorubicin, dated January 27, 2012.

FDA letter to Industry regarding drug shortage, dated October 31, 2011.

Labeling for methotrexate

Consumer Inquiries: 888-INFO-FDA

About the U.S. Food & Drug Administration (FDA)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA acts to bolster supply of critically needed cancer drugs, FDA News Release, U.S. Food & Drug Administration, February 21, 2012.

An Attitude of Gratitude On Thanksgiving Day

“Gratitude unlocks the fullness of life. It turns what we have into enough, and more. It turns denial into acceptance, chaos to order, confusion to clarity. It can turn a meal into a feast, a house into a home, a stranger into a friend. Gratitude makes sense of our past, brings peace for today, and creates a vision for tomorrow.” — Melody Beattie

Today, many of us will celebrate a national day of Thanksgiving with family and friends. You know the drill — eating turkey, mash potatoes, stuffing, and pumpkin or apple pie; watching football (your pick of Green Bay Packers vs. Detroit Lions, Miami Dolphins vs. Dallas Cowboys, or San Francisco 49ers vs. Baltimore Ravens); and napping, after which the whole cycle begins anew.

Why Be Grateful?

Within this traditional celebration, it is all too easy for us to lose sight of the real meaning of the holiday; that is, to give thanks for the many blessings bestowed upon us in our daily lives. Yesterday, I overheard two adults speaking about Thanksgiving in a grocery store line. One individual said to the second in a serious tone: “What do I have to be thankful for?” At first blush, it seems like a fair question when you consider the following:

• The U.S. is currently engaged in two major armed conflicts. As of November 22, the total number of Americans killed in Afghanistan and Iraq is 4,984, and the number of wounded is over 47,000. The conflict in Afghanistan hit the 10-year mark in October. In contrast, the U.S. forced the unconditional surrender of Nazi Germany and the Imperial Empire of Japan in 3 years and 8 months, thereby ending World War II in August 1945.

• The U.S. is experiencing the worst economic downturn since “The Great Depression” of the 20th century.

• The bipartisan U.S. Congressional “Super Committee” failed to reach agreement on $1.2 trillion of federal budget spending cuts over the next ten years, as part of Congress’ ongoing theater of the absurd in which its utter and total failure is “spun” as success.

• The U.S. Congress’ approval rating, based upon a recent New York Times poll, sits at an all-time low of 9 percent. By comparison, former President Richard Nixon’s final approval rating after the Watergate Scandal and upon his resignation was 23%.

• The U.S. National Cancer Institute (NCI) continues to fight for increased federal funding for cancer research in a time when 50% of men and 33% of women woman will experience cancer at some point during their lifetimes.

• It is estimated that 15,460 U.S. women will die from ovarian cancer in 2011, which represents the death of one woman every 37 minutes. The annual U.S. ovarian cancer death toll is equal to the number of passenger deaths that would result from 30 Boeing 747 airplane crashes every year.

• According to a recently published U.K. report, the median survival of women with ovarian cancer only increased from 8 months to 3 years over the past 40 years.

There is little doubt that the current state of U.S. affairs as described above is indeed daunting. The unsettling situation in the U.S., however, pales in comparison to the average life experience of those living in extreme poverty around the world (including the U.S.).

• In 2005, the World Bank reported that 1.4 billion people in the developing world (one in four) were living on less than US$1.25 per day, of which 162 million live on less than $0.50 per day. The latter category of individuals are referred to as the “ultra poor” by the International Food Policy Research Institute.

• Number of children in the world: 2.2 billion. Number of children living in poverty: 1 billion.

• According to the World Health Organization, there are approximately 33 million people living with HIV/AIDS today, with 2 million AIDS-related deaths anticipated each year. It is estimated that 76% of those deaths will occur in sub-Saharan Africa.

• The United Nations estimates that 34,000 children and 16,000 adults die each day from hunger or preventable diseases with poverty-related causes. The annual death total is 18 million per year, which is nearly two times greater than the total number of deaths that occurred throughout “The Holocaust” between 1933 and 1945.

• Approximately 1.1 billion people in developing countries have inadequate access to clean water, and 2.6 billion lack basic sanitation. Approximately 12 percent of the world’s population uses 85 percent of its water, and the individuals represented by the 12 percent do not live in the Third World.

• In 1997, it was estimated that less than 1 percent of annual world weapons expenditures was needed to put every child into school by the year 2000.

• Nearly one billion people entered the 21st century unable to read a book or sign their names.

• 1.6 billion people live without electricity.

• The U.S. has the widest gap between rich and poor of any industrialized nation.

• In 2008, 7.6 million people died of cancer or 13% of all deaths worldwide. About 70% of all cancer deaths occur in low- and middle-income countries.

In light of the above-mentioned global poverty statistics, it should be possible for even the most pessimistic U.S. citizen to be grateful on Thanksgiving Day. For the women and families who are dealing with ovarian cancer in their lives, we also believe that gratitude and hope is not only possible; it is essential.

• While cancers (including ovarian) constitute an incredibly diverse and bewilderingly complex set of diseases, we have at hand the methods to identify essentially all of the genetic changes in a cell and to use that knowledge to rework the landscape of cancer research and cancer care, from basic science to prevention, diagnosis, and treatment.

• With this better understanding of cancer and recent technological advances in many fields, such as genomics, molecular biology, biochemistry, and computational sciences, progress has been made on many fronts, and a portrait is beginning to emerge for several cancers including ovarian.

• It has been established that there are at least four major subtypes of epithelial ovarian cancer which should be treated as separate and distinct diseases.

• In The Cancer Genome Atlas (TCGA) study findings recently published with respect to the most common form of epithelial ovarian cancer, the investigators reported that a class of drugs known as “PARP inhibitors” may benefit up to 50% of high-grade, serous ovarian cancer (HGS-OvCa) survivors. In that same study, the investigators identified 22 genomic targets that occur in 10% or more of these cases, along with nearly 100 preclinical, clinical and FDA-approved drugs which are capable of “hitting” those targets.

• The TCGA study of HGS-OvCa is arguably the world’s largest genomic study of any form of cancer to date.

• Never before in human history has so much healthcare information been so readily available to the general public, thereby allowing cancer survivors and their families to proactively participate with their doctors in decisions relating to cancer diagnoses, treatments, and survivorship.

• Given the rapid technological and pharmacological developments described above, it is important to “live to fight another day.”

• Studies suggest that gratitude may improve overall health by leading to (i) better diet, (ii) increased amounts of exercise, (iii) reduced stress, and (iv) a stronger immune system. In other words, if you want to promote health, try giving thanks.

Thanksgiving In Times of Adversity & Plenty

“… As we gather in our communities and in our homes, around the table or near the hearth, we give thanks to each other and to God for the many kindnesses and comforts that grace our lives. Let us pause to recount the simple gifts that sustain us, and resolve to pay them forward in the year to come. …” — President Barack Obama

On November 16, 2011, U.S. President Barack Obama issued a Presidential Proclamation for Thanksgiving Day 2011. The proclamation is befitting of the true meaning underlying this traditional holiday. Although the origins of the modern U.S. Thanksgiving holiday can be traced back to the early 17th century, it is worth noting that the first Thanksgiving to be celebrated by all U.S. states on the same day (i.e., the final Thursday of November, which was not enacted into law by Congress until December 1941) was first proclaimed by President Abraham Lincoln on October 3, 1863. The year 1863 was arguably one of the darkest time periods in U.S. history because it occurred in the midst of the Civil War; a conflict that pitted brother against brother, and resulted in more American deaths than all subsequent U.S. conflicts combined. Despite that fact, President Lincoln believed strongly that we should give thanks for our daily blessings even in times of great adversity.

The main text of President Obama’s proclamation, which is provided below, echoes the sentiments of Lincoln and reminds all Americans that in good times and bad times, “… we have lifted our hearts by giving humble thanks for the blessings we have received and for those who bring meaning to our lives.”

“One of our Nation’s oldest and most cherished traditions, Thanksgiving Day brings us closer to our loved ones and invites us to reflect on the blessings that enrich our lives. The observance recalls the celebration of an autumn harvest centuries ago, when the Wampanoag tribe joined the Pilgrims at Plymouth Colony to share in the fruits of a bountiful season. The feast honored the Wampanoag for generously extending their knowledge of local game and agriculture to the Pilgrims, and today we renew our gratitude to all American Indians and Alaska Natives. We take this time to remember the ways that the First Americans have enriched our Nation’s heritage, from their generosity centuries ago to the everyday contributions they make to all facets of American life. As we come together with friends, family, and neighbors to celebrate, let us set aside our daily concerns and give thanks for the providence bestowed upon us.

Though our traditions have evolved, the spirit of grace and humility at the heart of Thanksgiving has persisted through every chapter of our story. When President George Washington proclaimed our country’s first Thanksgiving, he praised a generous and knowing God for shepherding our young Republic through its uncertain beginnings. Decades later, President Abraham Lincoln looked to the divine to protect those who had known the worst of civil war, and to restore the Nation “to the full enjoyment of peace, harmony, tranquility, and union.”

In times of adversity and times of plenty, we have lifted our hearts by giving humble thanks for the blessings we have received and for those who bring meaning to our lives. Today, let us offer gratitude to our men and women in uniform for their many sacrifices, and keep in our thoughts the families who save an empty seat at the table for a loved one stationed in harm’s way. And as members of our American family make do with less, let us rededicate ourselves to our friends and fellow citizens in need of a helping hand.

As we gather in our communities and in our homes, around the table or near the hearth, we give thanks to each other and to God for the many kindnesses and comforts that grace our lives. Let us pause to recount the simple gifts that sustain us, and resolve to pay them forward in the year to come. …” — Barack Obama’s Presidential Proclamation — Thanksgiving Day, 2011

If All Else Fails  — Try Humor

If you are still having trouble cultivating an attitude of gratitude on Thanksgiving Day, it is always helpful to enjoy the humor created by a child’s perspective. Thanksgiving is a time for food, family and fun, and we all know that children and grandchildren are a big part of the fun. Save Mart Supermarkets dared to create a video which captures a child’s perspective on the traditional Thanksgiving experience.  We should warn you that a broad smile is a common side effect of watching this video. Enjoy!

What Are We Thankful For?

Our Thanksgiving Day gratitude list includes the following:

• Ovarian cancer survivors and their families, who teach us every day about the importance of hope, perseverance, courage, compassion, love, and acceptance.

• The compassion of medical clinicians who treat ovarian cancer patients every day.

• The intelligence and dedication of U.S. and international medical and scientific researchers, who doggedly pursue methods to control, and ultimately conquer, ovarian cancer.

• The generous assistance provided to us by the Women’s Oncology Research & Dialogue (WORD) gynecological cancer awareness organization. Dr. Kelly Manahan (WORD Co-Founder), Dr. John Geisler (WORD Co-Founder), Nate Manahan (WORD Executive Director) and Chad Braham (WORD Director of Media Productions) provide Libby’s H*O*P*E* with invaluable substantive and technical assistance throughout the year, including the newest joint collaboration called “WORD of HOPE Ovarian Cancer Podcast.”

• The substantive assistance provided to us by the Ovarian Cancer Research Program of British Columbia, the British Columbia Cancer Agency, and the BC Cancer Foundation.

• The ongoing generosity, encouragement and hope provided by Douglas and Diana Gray through the Gray Family Ovarian Clear Cell Carcinoma Research Resource, a multi-year research project dedicated to understanding, and ultimately defeating, one of the most lethal subtypes of epithelial ovarian cancer.  The Talmud says: “And whoever saves a life, it is considered as if he saved an entire world.” Doug and Diana Gray are passionate about pioneering ovarian cancer research aimed at saving women’s lives.

• Our families who provide seemingly endless support and understanding, while we advocate on behalf of ovarian cancer survivors and their families.

• The inspiration provided by Libby’s eternal spirit.

• The ovarian cancer advocacy communities represented on Facebook, Twitter, Inspire.com, etc., who demonstrate on a daily basis that there is patient empowerment, joy, kindness, compassion, and synergy created by a large number of passionate and dedicated survivors and advocates who band together in cyberspace.

• The dedicated service of our U.S. military personnel (and their families), who allow us to rise and sleep under the blanket of freedom which they provide each day through blood, sweat, and tears.

• The roofs over our heads, the food on our tables, the clean water from our faucets, the freedom of speech and religious practice upon which our country was founded, the ability to vote in fair elections, and the simple acts of kindness that we are able to provide to and receive from others.

From our family to yours, let us take this opportunity to wish you a safe and enjoyable Thanksgiving holiday.

U.S. President Barack Obama Proclaims September 2011 As National Ovarian Cancer Awareness Month — What Should You Know?

Today, U.S. President Barack Obama designated September 2010 as National Ovarian Cancer Awareness Month. 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. 

Today, U.S. President Barack Obama designated September 2010 as National Ovarian Cancer Awareness Month. 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

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

• In 2011, the American Cancer Society (ACS) estimates that there will be approximately 21,990 new ovarian cancer cases diagnosed in the U.S. ACS estimates that 15,460 U.S. women will die from the disease, or about 42 women per day or 1 women every 30 minutes.

• 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.

• 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 other symptoms are not as useful in identifying ovarian cancer because they are also found in equal frequency in women in the general population who do not have the disease.

• 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.

• Pregnancy and the long-term use of oral contraceptives reduce the risk of developing ovarian cancer.

• Women who have had breast cancer, or who have a family history of breast cancer or ovarian cancer may have increased risk. Inherited mutations in the BRCA1 or BRCA2 gene increase a woman’s lifetime risk of breast and ovarian cancer. Women of Ashkenazi (Eastern European) Jewish ancestry are at higher risk (1 out of 40) for inherited BRCA gene mutations.

• 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.

• If diagnosed at the localized stage, the 5-year ovarian cancer survival rate is 92%; however, only about 19% of all cases are detected at this stage, usually fortuitously during another medical procedure.

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

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. Early stage diagnosis is associated with an improved prognosis.

Presidential Proclamation–National Ovarian Cancer Awareness Month

The White House

Office of the Press Secretary

For Immediate Release September 01, 2011

Presidential Proclamation–National Ovarian Cancer Awareness Month

NATIONAL OVARIAN CANCER AWARENESS MONTH, 2011

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

Ovarian cancer continues to have one of the highest mortality rates of any cancer, and it is a leading cause of cancer deaths among women in the United States. This month, we remember the mothers, sisters, and daughters we have lost to ovarian cancer, and we extend our support to those living with this disease. We also reaffirm our commitment to raising awareness about ovarian cancer, and to advancing our screening and treatment capabilities for the thousands of American women who will be diagnosed this year.

Ovarian cancer touches women of all backgrounds and ages. Because of a lack of early symptoms and effective screening tests, ovarian cancer is often not detected in time for successful interventions. It is crucial that women know how to recognize the warning signs of gynecological cancers and can detect the disease as early as possible. I encourage all women to learn about risk factors, including family history, and to discuss possible symptoms, including abdominal pain, with their doctor. Now, because of the Affordable Care Act, a wide range of preventive screenings are available to women without any copayments, deductibles, or coinsurance.

My Administration is committed to supporting the women, families, and professionals working to end this disease. The Centers for Disease Control and Prevention and the Department of Health and Human Services have started a campaign to educate women on cancers affecting reproductive organs. The National Cancer Institute is researching new ways to detect ovarian cancer, publishing a comprehensive study of the most aggressive types of ovarian cancer, and conducting clinical trials for new combinations of therapy. And this year, agencies across the Federal Government, from the National Institutes of Health to the Department of Defense, have committed to supporting ovarian cancer prevention and treatment research.

So many lives have been touched by ovarian cancer — from the women who fight this disease, to the families who join their loved ones in fighting their battle. In the memory of all the brave women who have lost their lives to ovarian cancer, and in support of generations of women to come, let us recommit to reaching a safer, healthier future for all our citizens.

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 2011 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. And I urge women across the country to talk to their health-care providers and learn more about this disease.

IN WITNESS WHEREOF, I have hereunto set my hand this first day of September, in the year of our Lord two thousand eleven, and of the Independence of the United States of America the two hundred and thirty-sixth.

BARACK OBAMA

Sources:

• Presidential Proclamation–National Ovarian Cancer Awareness Month 2011, issued September 1, 2011.

• Ovarian Cancer Symptoms Consensus Statement, Originating Organizations — Gynecologic Cancer Foundation, Society of Gynecologic Oncology & American Cancer Society, January – April, 2007.

Barack Obama Proclaims September 2009 As National Ovarian Cancer Awareness Month

Yesterday, U.S. President Barack Obama designated September 2009 as National Ovarian Cancer Awareness Month.  National Ovarian Cancer Awareness Month helps educate women and men about the importance of knowing the early warning signs and symptoms of the disease, scheduling routine doctor visits, and continuing robust scientific research.

Yesterday, U.S. President Barack Obama designated September 2009 as National Ovarian Cancer Awareness Month.  The official proclamation issued by the White House is set forth below.  National Ovarian Cancer Awareness Month helps educate women and men about the importance of knowing the early warning signs and symptoms, scheduling routine doctor visits, and continuing robust scientific research.

THE WHITE HOUSE

Office of the Press Secretary

______________________________________________________________________

For Immediate Release August 31, 2009

NATIONAL OVARIAN CANCER AWARENESS MONTH, 2009

– – – – – – –

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

Ovarian cancer remains the leading cause of death from gynecologic cancer among women in the United States. Every year, thousands are diagnosed and go on to fight the disease with grace and dignity. National Ovarian Cancer Awareness Month honors all those affected by this cancer and renews our commitment to fighting an illness that takes the lives of too many in our Nation.

Women are often diagnosed with ovarian cancer when it is already at an advanced stage. This problem can be attributed to a lack of effective early detection technologies and minimal or no specific symptoms associated with the disease. By learning more about risk factors and maintaining regular physician consultations, women have their best chance of early detection of ovarian cancer.

Science continues to expand our knowledge about this illness, promising hope to those who, years ago, would be without it. Through dedicated research, treatment outcomes have improved for many, and we are building a foundation for the development of evidence-based screening, which can help diagnose the disease at the earliest possible stage when the likelihood of cure is high.

This month we recommit to supporting the women who continue to battle valiantly against this malady as well as all families who are affected. National Ovarian Cancer Awareness Month helps educate women and men about the importance of knowing common signs and symptoms, scheduling routine doctor visits, and continuing robust scientific research. As a Nation, we are united in our resolve to reduce incidence and improve the lives of all those affected.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim September 2009 as National Ovarian Cancer Awareness Month. I encourage citizens, Government agencies, private businesses, nonprofit organizations, and other interested groups to join in activities that will increase awareness of what Americans can do to prevent and control ovarian cancer.

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

BARACK OBAMA

Source: NATIONAL OVARIAN CANCER AWARENESS MONTH, 2009, By the President of the United States of America, A Proclamation, Office of the Press Secretary For The President of the United States of America, The White House, August 31, 2009.

To Fight Cancer, Know The Enemy

An Op-Ed entitled “To Fight Cancer, Know the Enemy” was published in The New York Times on August 6, 2009.  The author of the Op-Ed was James D. Watson, Ph.D.  James Watson co-discovered the DNA double helix structure; a discovery for which he received the 1962 Nobel Prize for Physiology or Medicine. In the article, Watson states his belief that beating cancer is now a realistic ambition, and he makes several suggestions designed to ensure that victory.

On August 6, 2009, an Op-Ed entitled To Fight Cancer, Know the Enemy was published in The New York Times (NYT).  The author of the article was James D. Watson, Ph.D. James Watson co-discovered the DNA double helix structure; a discovery for which he received the 1962 Nobel Prize for Physiology or Medicine.  Dr. Watson is the Chancellor Emeritus of Cold Spring Harbor Laboratory, and is generally considered the father of molecular biology. Throughout most of his career, James Watson’s novel scientific ideas generated great controversy among, and resistance from, many members of the scientific community.  The suggestions posed by James Watson in his August 6th NYT Op-Ed are likely no exception.

Watson begins the Op-Ed by suggesting an ambitious, yet optimistic, goal in the area of cancer research:

“The National Cancer Institute, which has overseen American efforts on researching and combating cancers since 1971, should take on an ambitious new goal for the next decade:  the development of new drugs that will provide lifelong cures for many, if not all, major cancers.  Beating cancer now is a realistic ambition because, at long last, we largely know its true genetic and chemical characteristics. …”

James D. Watson, Ph.D. is the Chancellor Emeritus of the world-renowned Cold Spring Harbor Laboratory. Dr. Watson co-discovered DNA's double helix structure; a discovery for which he received the 1962 Nobel Prize for Physiology or Medicine. In an Op-Ed published in the New York Times on August 6, 2009, Dr. Watson states: "...Beating cancer now is a realistic ambition because, at long last, we largely know its true genetic and chemical characteristics."

Despite President Nixon’s declaration of  war on cancer in 1971, Watson states that the goal of “beating cancer” was not possible prior to the year 2000, because researchers did not possess the necessary scientific understanding of cancer molecular biology. Extensive details about specific cancers only became known after the 2003 completion of the Human Genome Project, says Watson. Researchers have identified most of the major cellular pathways through which cancer-inducing signals move through cells, and Watson notes that 20 or so signal-blocking drugs are in human clinical testing. By way of example, Watson highlights the breast cancer drug Herceptin, which is used to fight an aggressive form of breast cancer. Herceptin was approved initially by the U.S. Food & Drug Administration (FDA) in 1998, and today represents the standard of care in treating so-called “HER-2 positive” breast cancer.

With this scientific background, Dr. Watson outlines several suggested changes to the current U.S. cancer research paradigm. He believes that the various changes listed below will give the nation a fighting chance to win the war on cancer.

Change FDA Regulations To Allow Combination Testing of New Cancer Drugs Which Are Ineffective As Monotherapies.

Noting the lack of new cancer drugs that lead to lifelong cures, Watson explains that there are many types of cancer-causing “genetic drivers” within a single cancer cell. Although an analysis of several cancer genetic drivers may allow a doctor to prescribe more personalized chemotherapy treatments for the patient, Watson believes that use of drugs against one genetic cancer driver would simply lead to the emergence of increasingly destructive second and third drivers due to the inherent genetic instability of cancer cells.  Accordingly, Watson concludes that most anticancer drugs will not reach their full potential unless they are given in combination to shut down multiple cancer genetic drivers within a cancer cell simultaneously.

Dr. Watson, however, is quick to note that current FDA regulations effectively prohibit combination testing of new cancer drugs that, when administered alone, prove ineffective.  Thus, Watson concludes that current FDA regulations must be amended to allow combination testing of new cancer drugs that prove ineffective as monotherapies.

Better Understand The Chemical (Rather Than Genetic) Makeup of Cancer Cells

Dr. Watson believes that researchers should shift the current focus of cancer research away from decoding the genetic characteristics of cancer, and obtain a better understanding of the chemical reactions that occur within cancer cells. This suggestion, Watson explains, is based upon a 1924 discovery made by the German biochemist (and 1931 Nobel Laureate) Otto Warburg.  During experimentation, Warburg observed that cancer cells, irrespective of whether they grow in the presence or absence of oxygen, produce large amounts of lactic acid. Approximately one year ago, the significance of Warburg’s observation was revealed, says Watson. The metabolism of all proliferating cells (including cancer cells) is largely directed toward the synthesis of cellular building blocks from the breakdown of glucose. Based upon this recent discovery, Dr. Watson concludes that glucose breakdown runs faster in growing cells then in differentiated cells (i.e., cells that stop growing and perform specialized functions within the body).

The turbocharged breakdown of glucose in growing cells is attributable to growth-promoting signal molecules that effectively turn up the levels of transporter proteins which move glucose molecules into the cell, explains Watson. With this important discovery in hand, Watson suggests that researchers determine whether new drugs that specifically inhibit the key enzymes involved in the breakdown of glucose can produce an anticancer effect. Because this determination requires a better understanding of the chemical makeup of cancer cells, Watson believes that biochemists (rather than molecular biologists) will again move to the forefront of cancer research.

NCI Should Fund Smaller Biotechnology Companies & Increase Its Funding to Major Research-Oriented Cancer Centers

The next issue addressed by Dr. Watson relates to the lack of funding available to small biotechnology companies, which are generally engaged in highly innovative research. In the past, the requisite funding of these companies was provided by venture capitalists (VCs), Watson notes.  The level of VC funding required by small biotech companies is not currently available due to the severe U.S. economic downturn. To resolve this critical capital funding issue, Watson suggests that the National Cancer Institute (NCI) fund small biotech companies. This action, Watson believes, will allow the biotech companies to move drug discoveries from the laboratory into human clinical testing on an accelerated basis. In tandem with funding small biotech companies, Dr. Watson also requests NCI to increase its funding to major research-oriented cancer centers that engage in “low probability-high payoff” research projects, which are generally turned down by large pharmaceutical and biotech companies.

President Obama Should Appoint A Strong Leader To The Directorship of NCI

In 1971, the U.S. Congress provided the president, rather than the head of the National Institutes of Health, with the authority to appoint the NCI director.  Watson characterizes NCI in his Op-Ed as “an outpost of the White House” that has “… become a largely rudderless ship in dire need of a bold captain who will settle only for total victory.”  To resolve this issue, Dr. Watson advises President Barack Obama to appoint a strong leader, from among the nation’s best cancer researchers, to the directorship of NCI.  As part of this new leadership structure, Watson also recommends that NCI recruit a seasoned pharmaceutical developer who can radically increase the speed of anticancer drug development and human clinical testing.

Application Of Sun Tzu’s Strategies On The Art Of War To Cancer Research

A statue of the iconic Chinese military leader Sun Tzu. Sun Tzu wrote the earliest -- and still the most revered -- military treatise in the world. This 6th century BC masterpiece is best known to most of us as "The Art of War."

At the conclusion of his Op-Ed, Watson acknowledges that his views will provoke rebuttals from prominent scientists who believe that it is not the right time to wage war on cancer. Moreover, Watson anticipates that many scientists will recommend that, until victory is more certain, the U.S. should not expend large sums of money on cancer research. Watson admits that money alone will not win the war on cancer, but he emphasizes that victory over cancer will not come ” from biding our time.” As part of the Op-Ed title, Watson uses the phrase “know the enemy;” a phrase commonly attributed to the ancient Chinese military leader Sun Tzu. Sun Tzu wrote the earliest — and still the most revered — military treatise in the world.  This 6th century BC masterpiece is best known to most of us as The Art of War.  The clever use of the phrase “know the enemy” by Dr. Watson may suggest that the enemy is indeed cancer, and perhaps, ourselves as represented by the current U.S. cancer research paradigm.

In chapter III of The Art of War, entitled Attack by Stratagem, Sun Tzu describes the dual knowledge that one must possess to achieve ultimate victory in war:

“…If you know the enemy and know yourself, you need not fear the result of a hundred battles. If you know yourself but not the enemy, for every victory gained you will also suffer a defeat. If you know neither the enemy nor yourself, you will succumb in every battle. …”

To follow the advice of James Watson is to better know ourselves and the formidable enemy known as “cancer.” Will Watson’s advice allow us to achieve ultimate victory in the war on cancer? Perhaps. Only time (and appropriate research funding) will tell.

Source: To Fight Cancer, Know The Enemy, by James D. Watson, Op-Ed, The New York Times, August 6, 2009.