Eating Disorders

About eating disorders

“Mirror, Mirror on the wall…who’s the thinnest one of all?” According to the National Eating Disorders Association, the average American woman is 5 feet 4 inches tall and weighs 140 pounds. The average American model is 5 feet 11 inches tall and weighs 117 pounds. All too often, society associates being “thin”, with “hard-working, beautiful, strong and self-disciplined.” On the other hand, being “fat” is associated with being “lazy, ugly, weak and lacking will-power.” Because of these harsh critiques, rarely are women completely satisfied with their image. As a result, they often feel great anxiety and pressure to achieve and/or maintain an imaginary appearance.

Eating disorders are serious medical problems. Anorexia nervosa, bulimia nervosa, and binge-eating disorder are all types of eating disorders. Eating disorders frequently develop during adolescence or early adulthood, but can occur during childhood or later in adulthood. Females are more likely than males to develop an eating disorder.

Eating disorders are more than just a problem with food. Food is used to feel in control of other feelings that may seem overwhelming. For example, starving is a way for people with anorexia to feel more in control of their lives and to ease tension, anger, and anxiety. Purging and other behaviors to prevent weight gain are ways for people with bulimia to feel more in control of their lives and to ease stress and anxiety.

Although there is no single known cause of eating disorders, several things may contribute to the development of these disorders:

Culture. In the United States extreme thinness is a social and cultural ideal, and women partially define themselves by how physically attractive they are.

Personal characteristics. Feelings of helplessness, worthlessness, and poor self-image often accompany eating disorders.

Other emotional disorders. Other mental health problems, like depression or anxiety, occur along with eating disorders.

Stressful events or life changes. Things like starting a new school or job or being teased and traumatic events like rape can lead to the onset of eating disorders.

Biology. Studies are being done to look at genes, hormones, and chemicals in the brain that may have an effect on the development of, and recovery from eating disorders.

Families. Parents’ attitudes about appearance and diet can affect their kids’ attitudes. Also, if your mother or sister has bulimia, you are more likely to have it.

Over-exercising

For more information on exercise and healthy eating, visit our fitness and nutrition section.

Too much of a good thing can be very bad for you. Just like eating disorders, societal pressures to be thin can also push women to exercise too much. Over-exercise is when someone engages in strenuous physical activity to the point that is unsafe and unhealthy. In fact, some studies indicate that young women who are compelled to exercise at excessive levels are at risk for developing eating disorders.

Eating disorders and over-exercising go hand-in-hand — they both can be a result of an unhealthy obsession with your body. The most dangerous aspect of over-exercising is the ease with which it can go unrecognized. The condition can be easily hidden by an emphasis on fitness or a desire to be healthy. Like bulimia and anorexia, in which persons deny themselves adequate nutrition by restrictive eating behaviors, over-exercising is a controlled behavior that denies the body the energy and nutrition needed to maintain a healthy weight.

According to the American Journal of Sports Medicine, a host of physical consequences can result from over-exercising — pulled muscles, stress fractures, knee trauma, shin splints, strained hamstrings, and ripped tendons.

Remember, fitness should be done within limits and integrated into your lifestyle, done in moderation like everything else in life. If exercising is getting in the way of your daily activities or relationships, you may need to slow down.

More information on eating disorders see: womenshealth.gov
Anorexia Nervosa Fact Sheet— This fact sheet explains anorexia’s causes, signs and symptoms, and its effects on the body. It also provides information for pregnant women who have or have had anorexia.

Binge Eating Disorder Fact Sheet— This fact sheet provides information on binge eating disorder, including potential causes, associated risks, and possible treatments.

Bulimia Nervosa Fact Sheet— This fact sheet answers common questions about bulimia nervosa, including its causes, warning signs, complications, and available treatment options.

Explore other publications and websites:

50 Ways to Lose the 3 Ds: Dieting, Drive for Thinness, and Body Dissatisfaction (Copyright © National Eating Disorders Association) — This tip sheet offers advice about how you can improve your body image and make sure your children grow up with a positive body image, too.

Binge Eating Disorder — This fact sheet describes the symptoms, causes, complications, and treatment of binge eating disorder, and gives a profile of those at risk for the disorder.

Compulsive Exercise (Copyright © Nemours Foundation) — This publication provides information on compulsive exercise, its warning signs, and the serious effects it can have on a teenager’s health.

Consequences of Eating Disorders (Copyright © Academy for Eating Disorders) — This Web page describes the psychosocial and medical consequences of eating disorders over the long term. It has information about what happens to the different functions of your body, and other conditions that people with eating disorders are likely to have.

Diagnoses of Eating Disorders (Copyright © Academy for Eating Disorders) — This Web page describes the warning signs of various eating disorders and discusses how they are diagnosed. If you are worried about a friend or family member, this site can help you find out if certain behaviors could indicate an eating disorder.

Eating Disorders — This detailed booklet describes symptoms, causes, and treatments of eating disorders. It also includes information on getting help and coping.

Eating Disorders (Copyright © American Psychological Association) — This fact sheet describes anorexia, bulimia, and binge eating disorder, as well as who suffers from them and how a psychologist can help.

Eating Disorders (Copyright © Mayo Foundation) — This Web page describes the signs, symptoms, and causes of eating disorders, and gives information about treatments.

GirlsHealth.gov: Your Feelings — We have created the GirlsHealth.gov section to help adolescent girls (ages 10-16) learn more about some of the unique health issues and social situations they will encounter during the teen years. The feelings section provides resources and links to useful information to help you prepare to deal with some of the issues your girls will likely face.

How to Afford Appropriate Treatment for an Eating Disorder: A Guide for Patients & Their Families (Copyright © National Eating Disorder Association) — This publication provides detailed information about health insurance, where to find help for eating disorders, and where to get financial assistance for treatment.

How to Help a Friend with Eating and Body Image Issues (Copyright © National Eating Disorders Association) — This publication describes how you can help a friend who has a poor body image or an eating disorder.

Mental Health Services Locator — This website will help you locate mental health treatment facilities and support services in your state.

Orthorexia Nervosa (Copyright © National Eating Disorders Association) — This publication explains the symptoms of and treatment for orthorexia.

Risk Factors of Eating Disorders (Copyright © Academy for Eating Disorders) — This fact sheet discusses the risk factors that might make someone more likely to develop an eating disorder, such as gender, ethnicity, weight, and genetic factors.

Treatment (Copyright © Academy for Eating Disorders) — This fact sheet discusses different treatment options available for people with eating disorders. It includes information about the initial assessment, psychological treatments, medical treatments, and more.

What’s Going On With Me? Evaluating Eating and Exercising Habits (Copyright © National Eating Disorders Association) — This fact sheet explains the difference between regular and “disordered” eating. It identifies behaviors that are common in people with disordered eating, and explains how these behaviors can take a toll on your mental and physical well-being.

Connect with other organizations

Academy for Eating Disorders

American Psychological Association

Eating Disorders Anonymous

National Association of Anorexia Nervosa and Associated Disorders

National Association to Advance Fat Acceptance

National Eating Disorders Association

National Institute of Mental Health, NIH, HHS

Overeaters Anonymous

T.H.E. (Treatment, Healing, Education) Center for Disordered Eating

Source: U.S. Department of Health and Human Services Office on Women’s Health

post break

Posted in What You Need To Know | Tagged , , , , , , , , , , , , , , , | Comments Off

Cervical Cancer Screening

What is screening?

Screening is looking for cancer before a person has any symptoms. This can help find cancer at an early stage. When abnormal tissue or cancer is found early, it may be easier to treat. By the time symptoms appear, cancer may have begun to spread.

Cervical cancer is a disease in which malignant (cancer) cells form in the cervix.

The cervix is the lower, narrow end of the uterus (the hollow, pear-shaped organ where a fetus grows). The cervix leads from the uterus to the vagina (birth canal).

Cervical cancer usually develops slowly over time. Before cancer appears in the cervix, the cells of the cervix go through changes known as dysplasia, in which cells that are not normal begin to appear in the cervical tissue. Later, cancer cells start to grow and spread more deeply into the cervix and to surrounding areas.

The following summaries are about cervical cancer:

  • Cervical Cancer Treatment
  • Cervical Cancer Prevention

Screening for cervical cancer using the Pap test has decreased the number of new cases of cervical cancer and the number of deaths due to cervical cancer since 1950.

Cervical dysplasia occurs more often in women who are in their 20s and 30s. Death from cervical cancer is rare in women younger than 30 years and in women of any age who have regular screenings with the Pap test. The Pap test is used to detect cancer and changes that may lead to cancer. The chance of death from cervical cancer increases with age. Deaths from cervical cancer occur more often in black women than in white women.

Human papillomavirus (HPV) infection is the major risk factor for development of cervical cancer.

Although most women with cervical cancer have the human papillomavirus (HPV) infection, not all women with an HPV infection will develop cervical cancer. Many different types of HPV can affect the cervix and only some of them cause abnormal cells that may become cancer. Some HPV infections go away without treatment.

HPV infections are spread mainly through sexual contact. Women who become sexually active at a young age and have many sexual partners are at increased risk for HPV infections.

Other risk factors for cervical cancer include:

  • Having many sexual partners.
  • Giving birth to many children.
  • Having first sexual intercourse at a young age.
  • Smoking cigarettes.
  • Using oral contraceptives (“the Pill”).
  • Having a weakened immune system.

Tests are used to screen for different types of cancer.

Some screening tests are used because they have been shown to be helpful both in finding cancers early and in decreasing the chance of dying from these cancers. Other tests are used because they have been shown to find cancer in some people; however, it has not been proven in clinical trials that use of these tests will decrease the risk of dying from cancer.

Scientists study screening tests to find those with the fewest risks and most benefits. Cancer screening trials also are meant to show whether early detection (finding cancer before it causes symptoms) decreases a person’s chance of dying from the disease. For some types of cancer, the chance of recovery is better if the disease is found and treated at an early stage.

Clinical trials that study cancer screening methods are taking place in many parts of the country. Information about ongoing clinical trials is available from the NCI Web site.

Studies show that screening for cervical cancer helps decrease the number of deaths from the disease.

Regular screening of women between the ages of 25 and 60 years with the Pap test decreases their chance of dying from cervical cancer. In women younger than 25 years, screening with the Pap test may show changes in the cells of the cervix that are not cancer but lead to further testing and possibly treatment. Screening with the Pap test is not helpful in women older than 60 years who have had recent negative Pap tests.

A Pap test is commonly used to screen for cervical cancer.

A Pap test is a procedure to collect cells from the surface of the cervix and vagina. A piece of cotton, a brush, or a small wooden stick is used to gently scrape cells from the cervix and vagina. The cells are viewed under a microscope to find out if they are abnormal. This procedure is also called a Pap smear. A new method of collecting and viewing cells has been developed, in which the cells are placed into a liquid before being placed on a slide. It is not known if the new method will work better than the standard method to reduce the number of deaths from cervical cancer.

Screening tests have risks.

Decisions about screening tests can be difficult. Not all screening tests are helpful and most have risks. Before having any screening test, you may want to discuss the test with your doctor. It is important to know the risks of the test and whether it has been proven to reduce the risk of dying from cancer.

The risks of cervical cancer screening include the following:

False-negative test results can occur.

Screening test results may appear to be normal even though cervical cancer is present. A woman who receives a false-negative test result (one that shows there is no cancer when there really is) may delay seeking medical care even if she has symptoms.

False-positive test results can occur.

Screening test results may appear to be abnormal even though no cancer is present. Also, some abnormal cells in the cervix never become cancer. A false-positive test result (one that shows there is cancer when there really isn’t) can cause anxiety and is usually followed by more tests and procedures (such as colposcopy, cryotherapy, or LEEP), which also have risks. The long-term effects of these procedures on fertility and pregnancy are not known.

Women aged 20 to 24 are most likely to have abnormal Pap test results that lead to further testing and treatment.

Your doctor can advise you about your risk for cervical cancer and your need for screening tests.

Studies show that the number of cases of cervical cancer and deaths from cervical cancer are greatly reduced by screening with Pap tests. Many doctors recommend a Pap test be done every year. New studies have shown that after a woman has a Pap test and the results show no sign of abnormal cells, the Pap test can be repeated every 2 to 3 years.

The Pap test is not a helpful screening test for cervical cancer in the following groups of women:

  • Women who are younger than 25 years.
  • Women who have had a total hysterectomy (surgery to remove the uterus and cervix) for a condition that is not cancer.
  • Women who are aged 60 years or older and have a Pap test result that shows no abnormal cells. These women are very unlikely to have abnormal Pap test results in the future.

The decision about how often to have a Pap test is best made by you and your doctor.

Posted in What You Need To Know | Tagged , , , , , , , , , , , | Comments Off

Sleep Health

Sleep Health Overview

Goal
Increase public knowledge of how adequate sleep and treatment of sleep disorders improve health, productivity, wellness, quality of life, and safety on roads and in the workplace.

Overview
Poor sleep health is a common problem with 25 percent of U.S. adults reporting insufficient sleep or rest at least 15 out of every 30 days.1 The public health burden of chronic sleep loss and sleep disorders, coupled with low awareness of poor sleep health among the general population, health care professionals, and policymakers, necessitates a well-coordinated strategy to improve sleep-related health.

Why Is Sleep Health Important?
Sleep, like nutrition and physical activity, is a critical determinant of health and well-being.2 Sleep is a basic requirement for infant, child, and adolescent health and development. Sleep loss and untreated sleep disorders influence basic patterns of behavior that negatively affect family health and interpersonal relationships. Fatigue and sleepiness can reduce productivity and increase the chance for mishaps such as medical errors and motor vehicle or industrial accidents.3, 4

Adequate sleep is necessary to:

-Fight off infection
-Support the metabolism of sugar to prevent diabetes
-Perform well in school
-Work effectively and safely
-Sleep timing and duration affect a number of endocrine, metabolic, and neurological  functions that are critical to the maintenance of individual health. If left untreated, sleep disorders and chronic short sleep are associated with an increased risk of:

-Heart disease
-High blood pressure
-Obesity
-Diabetes
-All-cause mortality

Sleep health is a particular concern for individuals with chronic disabilities and disorders such as arthritis, kidney disease, pain, human immunodeficiency virus (HIV), epilepsy, Parkinson’s disease, and depression. Among older adults, the cognitive and medical consequences of untreated sleep disorders decrease health-related quality of life, contribute to functional limitations and loss of independence, and are associated with an increased risk of death from any cause.

Understanding Sleep Health
The odds of being a short sleeper (defined as someone who sleeps less than 6 hours a night) in the United States have increased significantly over the past 30 years.8 Competition between sleep schedules, employment, and lifestyle is a recent trend. Intermittent sleep disturbances due to lifestyle choices are associated with temporary fatigue, disorientation, and decreased alertness.

Sleep-disordered breathing (SDB), which includes sleep apnea, is another serious threat to health. SDB is characterized by intermittent airway obstruction or pauses in breathing. People with untreated SDB have 2 to 4 times the risk of heart attack and stroke.9, 10 Obesity is a significant risk factor for SDB, and weight loss is associated with a decrease in SDB severity

SDB in Children:
African American children are at least twice as likely to develop SDB than children of European descent.12 The risk of SDB during childhood is associated with low socioeconomic status independent of obesity and other risk factors.13 Left untreated, SDB in children is associated with difficulties in school, metabolic disorders, and future heart disease risk.

SDB in Older Adults:
SDB may affect 20 to 40 percent of older adults and, if left untreated, is associated with a 2- to 3-fold increased risk of stroke and mortality.15, 16
Sleep health education and promotion strategies are needed to address disparities in sleep health across age, race, education, and socioeconomic groups. Health education and promotion programs can increase awareness of common sleep disorders, such as insomnia, restless leg syndrome, and SDB. Sleep health education programs in workplaces can promote better work schedule patterns and motivate managers and workers to adopt strategies that reduce risks to health and safety. Without sleep health education, individuals often prioritize other activities over sleep and accept constant sleepiness and sleep disruption as inevitable.

Emerging Issues in Sleep Health
Progress in the following areas will yield more information on sleep health over the coming decade:

-Further evolution of biomedical sleep research.
-Quantification of health risks associated with untreated SDB across the lifespan.
-Findings from the first U.S.-based phase III SDB treatment trials in children and adults.

Objectives:
-Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical evaluation Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical evaluation
Baseline: 25.5 percent of persons with symptoms of obstructive sleep apnea sought medical evaluation in 2005–08 (age adjusted to the year 2000 standard population)

-Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving
Baseline: 2.7 vehicular crashes per 100 million miles traveled were due to drowsy driving in 2008.
-Increase the proportion of students in grades 9 through 12 who get sufficient sleep Increase the proportion of students in grades 9 through 12 who get sufficient sleep
Baseline: 30.9 percent of students in grades 9 through 12 got sufficient sleep (defined as 8 or more hours of sleep on an average school night) in 2009
-Increase the proportion of adults who get sufficient sleep Increase the proportion of adults who get sufficient sleep.

Source:  U.S. Department of Health and Human Services

post break

Posted in What You Need To Know | Tagged , , , , , , , , , , , , , , , , , , , , , , | Comments Off

Pelvic Inflammatory Disease (PID)

Pelvic Inflammatory Disease (PID)
Pelvic inflammatory disease (PID) is a general term that refers to infection and inflammation of the upper genital tract in women. It can affect the infection and inflammation (womb), fallopian tubes (tubes that carry eggs from the ovaries to the uterus), ovaries, and other organs related to reproduction. The scarring that results on these organs can lead to infertility, tubal (ectopic) pregnancy, chronic pelvic pain, abscesses (sores containing pus), and other serious problems. PID is the most common preventable cause of infertility in the United States.

Women at greater risk for PID include those at risk for sexually transmitted diseases (STDs) and those with a prior episode of PID. Sexually active women under age 25 are at risk as well because the cervix (opening to the uterus) of teens and young women has greater susceptibility to STDs. This may be because the cervix of teenage girls and young women is not fully matured, increasing their risk for STDs linked to PID.

Other potential risk factors include douching. Douching can change the vaginal flora and can force bacteria from the vagina into the upper reproductive organs. In some women, using an intrauterine device (IUD) to prevent pregnancy can also cause PID. Rarely, PID results from gynecological procedures or surgeries.

In the United States, it is estimated that more than 750.000 women suffer from an episode of acute PID each year, according to the Centers for Disease Control and Prevention (CDC). Up to 10-15% of women may become infertile as a result of PID.

Symptoms

Even if you have PID, you might not have symptoms. If you do have symptoms, they could be severe. The most common symptom of PID is pain in your lower abdomen. Other symptoms that you may or may not have include:

  • Fever
  • Vaginal discharge that may have an odor
  • Painful intercourse
  • Painful urination
  • Irregular menstrual bleeding
  • Pain in the upper right abdomen (rare)

Sometimes PID comes on suddenly with extreme pain and fever, especially if it is caused by gonorrhea.

Cause

Although many different microbes (germs) can cause PID, many cases of PID are associated with gonorrhea and chlamydia, two very common sexually transmitted infections caused by bacteria.

Prevention

The surest way to avoid getting or transmitting sexually transmitted diseases (STDs) is to abstain from sex or to be in a long-term, mutually monogamous relationship with a partner who has been tested and isn’t infected. Condoms, when used consistently and correctly, can reduce your risk of getting chlamydia and gonorrhea.

In addition, you can protect yourself from PID by getting treated quickly if you do get an STD.

The most common preventable cause of PID is an untreated STD, mainly chlamydia or gonorrhea. The Centers for Disease Control and Prevention recommends yearly chlamydia testing of all sexually active women age 25 or younger and  older women with risk factors for chlamydia (those who have a new sex partner or many sex partners). If you have had chlamydia, you also should be re-tested several months after completing treatment so you can be re-treated, if necessary.

Treatment

According to Centers for Disease Control and Prevention (CDC), healthcare providers should start treating sexually active young women and other women at risk for STIs if they have motion tenderness of the uterus, ovaries, fallopian tubes, or cervix. Without adequate treatment, 20 to 40 percent of women with chlamydia and 10 to 40 percent of women with gonorrhea may develop PID.

Many different bacteria may cause an episode of PID. Therefore, your healthcare provider will prescribe antibiotics (generally two at once, by injection or by mouth) that are effective against a wide range of bacteria, including those causing chlamydia and gonorrhea. You should begin treatment as soon as your healthcare provider diagnoses PID because you may prevent getting complications of the disease by taking antibiotics immediately.

Women who douche may have higher risk of developing PID. Douching can change the vaginal flora and can force bacteria from the vagina into the upper reproductive organs.

Even if your symptoms go away, you should finish taking all of the medicine. You also should return to your healthcare provider 2 to 3 days after beginning the medicine to be sure the antibiotics are working.

Your healthcare provider may recommend going into the hospital to treat your PID if you

  • Are severely ill
  • Are pregnant
  • Do not respond to or cannot take oral medicine
  • Need intravenous (in the vein) antibiotics
  • Have an abscess (swelling) in your fallopian tube or ovary

If your symptoms continue or if an abscess does not go away, you may need surgery.

Complications of PID such as chronic pelvic pain and scarring are difficult to treat, but sometimes they improve with surgery.

Many sex partners may be infected with bacteria that cause PID and do not know it because they do not have symptoms. To protect yourself from being re-infected with bacteria that cause PID, you should discuss this with your healthcare provider.

For updated information on treatment for PID, read the CDC STD Treatment Guidelines.

Complications

Prompt and appropriate treatment can help prevent complications of PID. Without treatment, PID can cause permanent damage to the female reproductive organs. Infection-causing bacteria can silently invade the fallopian tubes, causing normal tissue to turn into scar tissue. This scar tissue blocks or interrupts the normal movement of eggs into the uterus.

If your fallopian tubes are totally blocked by scar tissue, sperm cannot fertilize an egg and you become infertile. Infertility also can occur if the fallopian tubes are partially blocked or even slightly damaged. About one in five women with PID becomes infertile.

In addition, a partially blocked or slightly damaged fallopian tube may cause a fertilized egg to remain in the fallopian tube. If this fertilized egg begins to grow in the tube as if it were in the uterus, it is called an ectopic or tubal pregnancy. An ectopic pregnancy can rupture the fallopian tube, causing severe pain, internal bleeding, and even death.

Scarring in the fallopian tubes and other pelvic organs can also cause chronic pelvic pain (pain lasting for months or even years). You are more likely to suffer infertility (20 percent of women), ectopic pregnancy (9 percent), or chronic pelvic pain (18 percent) if you have repeated episodes of PID.

Source: U.S. Department of Health & Human Services

post break

Posted in What You Need To Know | Tagged , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

Creating An AIDS-Free Generation Remarks

Remarks on “Creating an AIDS-Free Generation”

Remarks by Hillary Rodham Clinton, Secretary of State
National Institutes of Health’s Masur Auditorium
Bethesda, MD November 8, 2011

Thank you. Thank you very much. Thank you. And it is, for me, a distinct personal pleasure to be back here at NIH, a set of institutions that I admire so much and which are so critically important not only to our own country and to the future of science here but indeed around the world.

I want to begin by thanking Francis Collins for his leadership and for the work that he has done. I well remember those times talking about your research and the extraordinary excitement around it, Francis.

And I want to thank Tony for his kind words but also his leadership. It’s not easy to follow one of the top 20 federal employees of all time. (Laughter.) But I think Government Executive Magazine got it just right – a richly deserved recognition.

As I came in, I saw some other friends: Dr. Harold Varmus, with whom I’ve had the privilege to work both when he was here at NIH and then in New York; Dr. Nora Volkow and her work which is so important; and Dr. John Gallin as well.

But for me, this is a special treat because here in this room are some of America’s best scientists and most passionate advocates, true global health heroes and heroines, in an institution that is on the front lines of the fight against HIV/AIDS.

I want to recognize some special people who are here today: Ambassador Eric Goosby, our Global AIDS Coordinator, and his predecessor, Mark Dybul; Lois Quam, the executive director of our Global Health Initiative; Dr. Tom Frieden from the Centers for Disease Control and Prevention; UNAIDS Executive Director Michel Sidibe; and others who are part of this Administration’s global health efforts and the multilateral organizations with which we work.

I also want to acknowledge two people who could not be with us: first, USAID Administrator Dr. Raj Shah, who has had such a positive impact on our health and development work; and, second, I am delighted to announce our new special envoy. We love special envoys at the State Department. (Laughter.) Our new Special Envoy for Global AIDS Awareness: Ellen DeGeneres. (Applause.) And Ellen is going to bring not only her sharp wit and her big heart, but her impressive TV audience and more than 8 million followers on Twitter, to raise awareness and support for this effort. I know we can look forward to many contributions from Ellen and her loyal fans across the globe.

Now, many of you know because you were there: The fight against AIDS began three decades ago in June 1981. American scientists reported the first evidence of a mysterious new disease. It was killing young men by leaving them vulnerable to rare forms of pneumonia, cancer, and other health problems. Now, at first, doctors knew virtually nothing about this disease. Today, all those years later, we know a great deal.

We know, of course, about its horrific impact. AIDS has killed 30 million people around the world, and 34 million are living with HIV today. In Sub-Saharan Africa—where 60 percent of the people with HIV are women and girls—it left a generation of children to grow up without mothers and fathers or teachers. In some communities, the only growth industry was the funeral business.

Thirty years later, we also know a great deal about the virus itself. We understand how it is spread, how it constantly mutates in the body, how it hides from the immune system. And we have turned this knowledge to our advantage—developing ingenious ways to prevent its transmission and dozens of drugs that keep millions of people alive. Now, AIDS is still an incurable disease, but it no longer has to be a death sentence.

Finally, after 30 years, we know a great deal about ourselves. The worst plague of our lifetime brought out the best in humanity. Around the world, governments, businesses, faith communities, activists, individuals from every walk of life have come together, giving their time, their money—along with their heads and hearts—to fight AIDS.

Although the past 30 years have been a remarkable journey, we still have a long, hard road ahead of us. But today, thanks both to new knowledge and to new ways of applying it, we have the chance to give countless lives and futures to millions of people who are alive today, but equally, if not profoundly more importantly, to an entire generation yet to be born.

Today, I would like to talk with you about how we arrived at this historic moment and what the world now can and must do to defeat AIDS.

From its earliest days, the fight against HIV/AIDS has been a global effort. But in the story of this fight, America’s name comes up time and again. In the past few weeks, I’ve spoken about various aspects of American leadership, from creating economic opportunity to preserving peace and standing up for democracy and freedom. Well, our efforts in global health are another strong pillar in our leadership. Our efforts advance our national interests. They help make other countries more stable and the United States more secure. And they are an expression of our values—of who we are as a people. And they generate enormous goodwill.

At a time when people are raising questions about America’s role in the world, our leadership in global health reminds them who we are and what we do, that we are the nation that has done more than any other country in history to save the lives of millions of people beyond our borders.

Our efforts must begin with the American public: from people living with the disease, to researchers in academic medical centers; to individual donors, businesses, and foundations; and philanthropies – two of my favorite ones, the Clinton Foundation – (laughter) – which helped make treatment more affordable by supporting innovative ways to manufacture and purchase drugs; the Bill & Melinda Gates Foundation, which has underwritten breakthrough research.

But let’s remind ourselves no institution in the world has done more than the United States Government. (Applause.) We have produced a track record of excellence in science. Researchers right here at the NIH conducted pivotal research that identified HIV and proved that it did cause AIDS. The first drug to treat AIDS was supported by the United States. Today we are making major investments in the search for a vaccine; for tools like microbicides, which give women the power to protect themselves; and other lifesaving innovations.

Alongside our research and development work, the United States has led a global effort to bring these advances to bear in saving lives. When my husband was president, he appointed America’s first AIDS czar and more than tripled U.S. investments in preventing and treating AIDS worldwide. And in 2003, President Bush, with strong bipartisan support from Congress, made the momentous decision to launch the President’s Emergency Plan for AIDS Relief, or PEPFAR.

At that time, only 50,000 people in Sub-Saharan Africa were receiving the antiretroviral drugs that would keep them alive. Now, more than 5 million do, along with more than a million people in other regions of the world, and the vast majority receive drugs financed by either PEPFAR or the Global Fund to Fight AIDS, Tuberculosis, and Malaria, which the United States helped create.

And PEPFAR is having an impact far beyond AIDS. It has expanded on the World Health Organization’s efforts to treat and prevent tuberculosis, which is the leading cause of death among people with AIDS. PEPFAR has also helped build new facilities throughout our partner countries that see patients not just for HIV/AIDS, but for malaria, for immunizations, and much more. To staff these clinics, we have helped train a new cadre of professional health workers who are making their countries more self-sufficient. In some countries, the same trucks that deliver AIDS medicine now also deliver bed nets to prevent malaria.

For all these reasons, PEPFAR is one of the strong platforms upon which the Obama Administration is building our Global Health Initiative, which supports one-stop clinics offering an array of health services while driving down costs, driving up impact, and saving more lives. I say all of this because I want the American people to understand the irreplaceable role the United States has played in the fight against HIV/AIDS. It is their tax dollars, our tax dollars, that have made this possible, and we need to keep going.

To be sure, we have done it in an ever-expanding partnership with other governments, multilateral institutions, implementing organizations, the private sector, civil society groups, especially those led by people living with the virus. But the world could not have come this far without us, and it will not defeat AIDS without us.

What’s more, our efforts have helped set the stage for a historic opportunity, one that the world has today: to change the course of this pandemic and usher in an AIDS-free generation.

Now, by an AIDS-free generation, I mean one where, first, virtually no children are born with the virus; second, as these children become teenagers and adults, they are at far lower risk of becoming infected than they would be today thanks to a wide range of prevention tools; and third, if they do acquire HIV, they have access to treatment that helps prevent them from developing AIDS and passing the virus on to others.

Now, HIV may be with us well into the future. But the disease that it causes need not be. This is, I admit, an ambitious goal, and I recognize I am not the first person to envision it. But creating an AIDS-free generation has never been a policy priority for the United States Government until today, because this goal would have been unimaginable just a few years ago. Yet today, it is possible because of scientific advances largely funded by the United States and new practices put in place by this Administration and our many partners. Now while the finish line is not yet in sight, we know we can get there, because now we know the route we need to take. It requires all of us to put a variety of scientifically proven prevention tools to work in concert with each other. Just as doctors talk about combination treatment – prescribing more than one drug at a time – we all must step up our use of combination prevention.

America’s combination prevention strategy focuses on a set of interventions that have been proven most effective – ending mother-to-child transmission, expanding voluntary medical male circumcision, and scaling up treatment for people living with HIV/AIDS. Now of course, interventions like these can’t be successful in isolation. They work best when combined with condoms, counseling and testing, and other effective prevention interventions. And they rely on strong systems and personnel, including trained community health workers. They depend on institutional and social changes like ending stigma; reducing discrimination against women and girls; stopping gender-based violence and exploitation, which continue to put women and girls at higher risk of HIV infection; and repealing laws that make people criminals simply because of their sexual orientation.

Even as we recognize all these crucial elements, today I want to focus on the three key interventions that can make it possible to achieve an AIDS-free generation. First, preventing mother-to-child transmission. Today, one in seven new infections occurs when a mother passes the virus to her child. We can get that number to zero. I keep saying zero; my speechwriter keeps saying “Virtually zero.” (Laughter, applause.) And we can save mother’s lives too.

In June, I visited the Buguruni Health Center in Tanzania, and there I met a woman living with HIV who had recently given birth to a baby boy. She had been coming to the clinic throughout her pregnancy for medication and information because she desperately wanted her boy to get a healthy start in life, and most especially, she wanted him to be born HIV-free. When we met, she had just received the best news she could have hoped for. Her son did not have the virus. And thanks to the treatment she was getting there, she would live to see him grow up.

This is what American leadership and shared responsibility can accomplish for all mothers and children. The world already has the necessary tools and knowledge. Last year alone, PEPFAR helped prevent 114,000 babies from being born with HIV. Now, we have a way forward too. PEPFAR and UNAIDS have brought together key partners to launch a global plan for eliminating new infections among children by 2015. And we continue to integrate prevention and treatment efforts with broader health programs, which not only prevents HIV infections, but also keeps children healthy and helps mothers give birth safely.

In addition to preventing mother-to-child transmission, an effective combination prevention strategy has to include voluntary medical male circumcision. In the past few years, research has proven that this low-cost procedure reduces the risk of female-to-male transmission by more than 60 percent, and that the benefit is life-long.

Since 2007, some 1,000,000 men around the world have been circumcised for HIV prevention. Three fourths of these procedures have been funded by PEPFAR. In Kenya and Tanzania alone, during special campaigns, clinicians perform more than 35,000 circumcisions a month.

In the fight against AIDS, the ideal intervention is one that prevents people from being infected in the first place, and the two methods I’ve described – mother-to-child transmission, voluntary medical male circumcision – are the most cost-effective interventions we have, and we are scaling them up. But even once people do become HIV-positive, we can still make it far less likely that they will transmit the virus to others by treating them with the antiretroviral drugs. So this is the third element of combination prevention that I want to mention.

Thanks to U.S. Government-funded research published just a few months ago, we now know that if you treat a person living with HIV effectively, you reduce the risk of transmission to a partner by 96 percent.

Of course, not everyone takes the medication exactly as directed, and so some people may not get the maximum level of protection. But even so, this new finding will have a profound impact on the fight against AIDS.

For years, some have feared that scaling up treatment would detract from prevention efforts. Now we know beyond a doubt if we take a comprehensive view of our approach to the pandemic, treatment doesn’t take away from prevention. It adds to prevention. So let’s end the old debate over treatment versus prevention and embrace treatment as prevention.

There’s no question that scaling up treatment is expensive. But thanks to lower costs of drugs, bulk purchasing, and simple changes like shipping medication by ground instead of air, we and our partners are reducing the cost of treatment. In 2004, the cost to PEPFAR for providing ARVs and services to one patient averaged nearly $1,100 a year. Today, it’s $335 and falling. Continuing to drive down these costs is a challenge for all of us, from donors and developing countries to institutions like the Global Fund.

Treating HIV-positive people before they become ill also has indirect economic benefits. It allows them to work, to support their families, contribute to their communities. It averts social costs, such as caring for orphans whose parents die of AIDS-related illnesses. A study published just last month weighed the costs and benefits and found that – I quote – “the economic benefits of treatment will substantially offset, and likely exceed, program costs within 10 years of investment.” In other words, treating people will not only save lives, it will generate considerable economic returns as well.

Now, some people have concerns about treatment as prevention. They argue that many people transmit the virus to others shortly after they have acquired it themselves, but before they have begun treatment. That is a legitimate concern, and we are studying ways to identify people sooner after transmission and help them avoid spreading the virus further. But to make a big dent in this pandemic, we don’t need to be able to identify and treat everyone as soon as they are HIV-positive. In places where the pandemic is well established, as it is in most of Sub-Saharan African countries, most transmissions come not from people who are newly infected, but from people with longstanding HIV infections who need treatment now or soon will. We already have the tests we need to identify these people. If they receive and maintain their treatment, their health will improve dramatically, and they will be far less likely to transmit the virus to their partners.

Now let me be clear: None of the interventions I’ve described can create an AIDS-free generation by itself. But used in combination with each other and with other powerful prevention methods, they do present an extraordinary opportunity. Right now, more people are becoming infected every year than are starting treatment. We can reverse this trend. Mathematical models show that scaling up combination prevention to realistic levels in high-prevalence countries would drive down the worldwide rate of new infections by at least 40 to 60 percent. That’s on top of the 25 percent drop we’ve already seen in the past decade.

As the world scales up the most effective prevention methods, the number of new infections will go down, and it will be possible to treat more people than are becoming infected each year. And so, instead of falling behind year after year, we will, for the first time, get ahead of the pandemic. We will be on the path to an AIDS-free generation. That is the real power of combination prevention.

But success is not inevitable, nor will it be easy. Coverage levels for many of these interventions are unacceptably low. And we know from experience that to scale them up, we have to be able to deliver them not just in hospitals, but in clinics located in communities of every size and shape. If we’re going to make the most of this moment, there are steps we must take together.

First, we need to let science guide our efforts. Success depends on deploying our tools based on the best available evidence. Now, I know that occasionally it feels in and around Washington that there are some who wish us to live in an evidence-free zone. (Laughter.) But it’s imperative – (applause) – that we stand up for evidence and for science. Facts are stubborn things, and we need to keep putting them out there, even though they might, in the short term, be dismissed. Eventually, we will prevail.

Through PEPFAR and across the government, the United States is using scientifically proven results to inform our policy, which leads to real change for programs on the ground and maximizes the impact of our investments. For example, we need more research to identify the most effective ways to combine these interventions in different contexts. We know HIV is a complex pandemic that varies from country to country, district to district, from urban areas to rural. It’s the same in our own country. Combination prevention needs to reflect this complexity. Which combinations are most effective in areas where the virus is concentrated in especially vulnerable populations? What about places where it is more widespread in the general population?

We’re already working to answer these questions. We recently granted more than $50 million to three of the world’s leading academic institutions to develop rigorous studies that test what works in various settings. Today, I’m pleased to announce that we’re stepping up our efforts. The United States, through PEPFAR, will commit an additional $60 million to rapidly scale up combination prevention in parts of four countries in Sub-Saharan Africa and to rigorously measure the impact.

The results will have implications for every country where we work and for our partners as well. They will help ensure that we are translating the science into services that deliver the most impact and will allow us to take bigger steps together in our march toward an AIDS-free generation. I want to challenge other donors to join us in this effort. Go out and find partner countries that will work with you to test the most effective combinations of tools. Scale up support for treating as many people as possible. Measure the impact and share the results, so we can all learn from each other.

The second step is to put more emphasis on country ownership of HIV/AIDS programs. This is a priority for the United States. We know we can’t create an AIDS-free generation by dictating solutions from Washington. Our in-country partners – including governments, NGOs, and faith-based organizations – need to own and lead their nation’s response. So we are working with ministries of health and local organizations to strengthen their health systems so they can take on an even broader range of health problems.

Country ownership also means that more partner countries need to share more responsibility for funding the fight against HIV/AIDS within their borders. Some countries have allowed money from outside donors to displace their own investments in health programs; well, if PEPFAR or the Global Fund or another donor is going to be giving us money for health, we can just take that money out of health and build some more roads. That has to change and we have to demand that it change. More countries need to follow the lead of South Africa, Nigeria, Senegal, Rwanda, Zambia, and others that are committing larger shares of their own budgets to HIV/AIDS.

Finally, we’re calling on other donor nations to do their part, including by supporting and strengthening the Global Fund. Consider just one example of what the Global Fund has already done. In 2004, virtually none of the people in Malawi who were eligible to receive treatment actually received it. As of last year, with significant help from the Global Fund, nearly half did.

This kind of progress deserves our support. The United States is the largest individual contributor to the Fund, and the Obama Administration has made our country’s first multiyear pledge to it. Some donors are, unfortunately, considering reducing their contributions. Some emerging powers and nations that are rich in natural resources can afford to give, but choose not to. To sit on the sidelines now would be devastating. It would cost lives, and we would miss out on this unprecedented opportunity. When so many people are suffering, and we have the means to help them, we have an obligation to do what we can.

And for its part, the Global Fund has its own responsibilities to meet. The United States has supported reforms at the Fund to ensure that its resources are reaching those in need and that they are focused on cost-effective, evidence-based solutions. The Fund is conducting a number of audits and investigations that have surfaced reports of fraud and corruption. It is the Fund’s responsibility to root out these abuses and end them as quickly as possible.

But let’s remember, uncovering problems is exactly what transparency is supposed to do. It means the process is working. So let’s not put the Global Fund into some kind of catch-22. Go be transparent, go be accountable, and when you find problems, we’re going to take money away from you. Now, from day one, the United States Congress has insisted that our contributions to the Global Fund support accountable programs that produce measurable outcomes. And it’s been my experience that the American people are happy to support lifesaving programs if they know they really work. And this is how we show them.

The goal of an AIDS-free generation may be ambitious, but it is possible with the knowledge and interventions we have right now. And that is something we’ve never been able to say without qualification before. Imagine what the world will look like when we succeed. Imagine AIDS wards that once were stretched far beyond their capacity becoming outpatient clinics caring for people with a manageable condition, children who might have been orphaned and then trafficked or recruited as child soldiers instead growing up with the hope of a better future, communities where despair once reigned filled instead with optimism, countries that can make the most of every single person’s God-given potential. That is the world that has always been at the core of American belief, and we have worked toward it in our own history. It’s the world I think we all would like to live in. An AIDS-free generation would be one of the greatest gifts the United States could give to our collective future.

Much of what we do will depend upon the people in this room and the hundreds and thousands like you – the researchers and scientists, the public health docs and nurses and other personnel, the community health workers, the funders and donors, the government officials, the business leaders, philanthropies, and faith communities that have all joined together in this quite remarkable way to combat this disease.

So I end where I started. We’ve made a lot of progress together in the last 30 years. It hasn’t been easy. It hasn’t been without controversy. But it has been steady, and we have stayed the course as a nation. In these difficult budget times, we have to remember that investing in our future is the smartest investment we can make. And generations of American policymakers and taxpayers have supported the NIH, medical research, scientific work, not because we thought everything was going to produce an immediate result but because we believe that through these investments, human progress would steadily, steadily continue.

Let’s not stop now. Let’s keep focused on the future. And one of those futures that I hope we can be part of achieving is an AIDS-free generation. Thank you all very much.

Source: National Institute of Health

post break

Posted in What You Need To Know | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

The VOICE HIV Prevention Study

What is the VOICE study? Updated November 25, 2011

VOICE stands for “Vaginal and Oral Interventions to Control the Epidemic.” The VOICE study, also known as MTN-003, is a large, Phase IIb clinical trial originally designed to determine whether drugs used to treat HIV infection can also prevent male-to-female HIV transmission when used daily. The study, which is being carried out among HIV-negative women in three African countries, was originally designed to test the safety and effectiveness of two HIV prevention strategies: an investigational vaginal microbicide gel containing the antiretroviral drug tenofovir (1 percent concentration), and oral tablets containing tenofovir or a combination of tenofovir and another antiretroviral drug, emtricitabine. Taking the tablets daily to try to prevent HIV infection is a strategy known as oral pre-exposure prophylaxis, or PrEP.

On September 16, 2011, a routine review by an independent data and safety monitoring board (DSMB) found that the VOICE study would be unable to show a difference between tenofovir tablets and placebo tablets in their effectiveness at preventing HIV infection in the study participants. Consequently, the DSMB recommended that the trial discontinue testing oral tenofovir. For more information about this change, please see the answer to question 14 below.

In another scheduled review on November 17, 2011, the DSMB found that tenofovir gel was ineffective at preventing HIV infection in VOICE study participants. The DSMB therefore recommended that the trial also discontinue testing tenofovir gel. For more information about this change, please see the answer to question 15 below.
What is a microbicide?

A microbicide is designed to prevent HIV infection when applied topically inside the vagina or the rectum in the form of a gel, film or ring. No microbicide has been approved for use outside of research studies.

In July 2010, the CAPRISA 004 study found that a vaginal microbicide gel demonstrated a 39 percent level of efficacy at preventing HIV infection. The microbicide tested in that study contained the antiretroviral drug tenofovir at a concentration of 1 percent–the same as in the VOICE study. Study participants applied the microbicide before and after sex.

In the VOICE study, the microbicide was applied once daily.
What is oral PrEP?

Oral PrEP is an investigational strategy to prevent HIV infection by giving a daily oral dose of one or two antiretroviral drugs to HIV-negative people who are at risk for becoming infected. Scientists theorize that taking an antiretroviral drug before exposure to HIV could potentially inhibit HIV replication immediately after exposure to the virus, thereby thwarting the establishment of permanent infection.

In November 2010, the NIAID-sponsored iPrEx study demonstrated the safety and effectiveness of oral tablets containing combination tenofovir and emtricitabine at preventing HIV infection in men who have sex with men and in transgender women who have sex with men. In July 2011, two PrEP studies demonstrated the safety and effectiveness of both oral tenofovir and oral tenofovir/emtricitabine at preventing HIV infection in heterosexual men and women.
Who is participating in the VOICE study, and where is it being conducted?

The study team has enrolled 5,029 sexually active, HIV-uninfected women ages 18 to 45 into the clinical trial, which is taking place at 15 sites External Web Site Policyin South Africa, Uganda and Zimbabwe.
Who is funding the VOICE study?

The National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring and funding the VOICE study with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all part of the U.S. National Institutes of Health. The co-sponsors are CONRAD of Arlington, Va., and Gilead Sciences Inc. of Foster City, Calif.

Gilead Sciences is providing tenofovir and tenofovir/emtricitabine tablets to the VOICE study team free of charge, and CONRAD is providing tenofovir gel and gel applicators. Oral tenofovir is known by the brand name Viread. Co-formulated tenofovir/emtricitabine is known by the brand name Truvada.
Who is conducting the VOICE study?

The study is being conducted by theMicrobicide Trials NetworkExternal Web Site Policy, which is funded by NIAID with co-funding from NICHD and NIMH.

Leading the VOICE study are protocol co-chairs Zvavahera Mike Chirenje, M.D., F.C.R.O.G., of the University of Zimbabwe in Harare, and Jeanne Marrazzo, M.D., M.P.H., of the University of Washington in Seattle.
When did the VOICE study begin? When are results expected?

The VOICE study began in September 2009, and results are expected in early 2013.
Which microbicide and oral PrEP regimens were originally being tested in the VOICE study, and what is being tested now?

The VOICE study originally was testing the safety and effectiveness of an investigational microbicide gel containing the antiretroviral drug tenofovir at a concentration of 1 percent. In addition, the study originally was testing the safety and efficacy of two oral PrEP regimens: a daily dose of 300 mg tenofovir, and a daily dose of 300 mg tenofovir plus 200 mg emtricitabine combined into one pill.

Investigators stopped testing oral tenofovir in September 2011 and stopped testing tenofovir gel in November 2011 following decisions by NIAID to accept the recommendations of an independent DSMB. For more information about these changes to the study, please see the answers to questions 14 and 15 below.
Why is the VOICE study important?

The VOICE study is important for several reasons. First, an effective microbicide or oral PrEP regimen could give women an HIV prevention method they control. This would be particularly helpful in situations where it is difficult or impossible for women to refuse sex or to negotiate condom use with their male partners. Women make up slightly more than half of all people worldwide living with HIV, and in sub-Saharan Africa, women represent nearly 60 percent of adults living with the virus. In most cases, women become infected with HIV through sex with an infected male partner.

In addition, if a regimen under study in VOICE is found to be effective, it could expand the number of HIV prevention tools available to curb the HIV/AIDS pandemic. The best offense against HIV infection is a comprehensive prevention toolkit that can be tailored to meet the needs of specific populations.

How does the VOICE study differ from other clinical trials of microbicides or oral PrEP?

The VOICE study is the first to test the effectiveness of a microbicide gel that women apply once daily rather than shortly before or after they have sexual intercourse. It is also one of the first large-scale clinical trials of the newer class of microbicides that contain an antiretroviral drug and thus act specifically against HIV.

The VOICE study also is the first to test a microbicide and oral PrEP in the same clinical trial. This approach aimed to enable researchers to directly compare the safety, effectiveness and acceptability of the two experimental HIV prevention strategies in adult heterosexual women. The study also is examining whether the antiretroviral drug-containing prevention strategies generate drug resistance, and if so, to what extent.
What is the study design?

VOICE was originally designed as a Phase IIb, five-arm, multi-site, placebo-controlled trial. Participants were assigned at random to one of five regimens, each performed once daily:

  • applying tenofovir gel vaginally
  • applying a placebo gel vaginally
  • taking a tenofovir pill and a placebo pill
  • taking a tenofovir/emtricitabine (Truvada) pill and a placebo pill
  • taking two placebo pills

In addition to testing tenofovir gel and oral PrEP for safety and effectiveness, the VOICE study aimed to determine which regimen—pill or gel—women were likely to follow more consistently and whether either intervention influences the risk-taking behavior of participants. The study also is assessing how frequently participants who acquire HIV during the trial develop resistance to tenofovir or to tenofovir/emtricitabine.

Study staff are following each participant for 14 to 36 months. At study visits, all participants receive HIV tests and risk-reduction counseling, condoms and testing for sexually transmitted infections. Any participant who acquires HIV or a sexually transmitted infection during the study is referred to appropriate treatment and care in her community.
How is the safety of the VOICE study participants protected? Safety is monitored closely throughout the study. Designed according to the most rigorous standards of international medical practice and ethics, the VOICE study contains numerous measures, beginning at the site level, intended to protect the safety and well-being of participants. These include a multi-tiered safety review process with strict U.S. and international procedures for monitoring and reporting of adverse events.
What is a DSMB, and what is its role in the VOICE study?

A DSMB is an independent group composed of clinical research experts, statisticians, ethicists and community representatives that meets at regular intervals during the study to review data as it is gathered. (The study team does not have access to pivotal study data until the clinical trial ends.) The DSMB alerts the study team if anything appears to compromise the safety of study participants, if there is compelling evidence of effectiveness, or if it becomes clear that the study cannot answer one of the questions it was designed to address.

The NIAID Prevention Trials DSMB regularly reviews the data from the VOICE study and has conducted six reviews to date. The November 17, 2011, meeting of the DSMB was the fifth interim review of safety data and the third of effectiveness data. The first DSMB review examined the study design before the clinical trial began.
Why did the study team stop testing oral tenofovir?

During a routine review of the VOICE study data on September 16, 2011, the DSMB found that the trial would be unable to show a significant difference between tenofovir tablets and placebo tablets in their ability to prevent HIV infection in study participants. (This situation is known as “futility” in the context of a clinical trial.) As a result of this finding, the DSMB recommended that the study discontinue evaluating tenofovir tablets while continuing to evaluate tenofovir gel and tenofovir/emtricitabine tablets as designed. Notably, the DSMB found no safety concerns with any study product.

NIAID concurred with the DSMB’s recommendations.

To protect the integrity of the ongoing clinical trial, the study data remain confidential to everyone except the DSMB until the study ends. Until that time, NIAID will not know or speculate about why oral tenofovir showed no effect among the VOICE study participants.
Why did the study team stop testing tenofovir gel?

During a planned interim review of the VOICE study data on November 17, 2011, the DSMB found that tenofovir gel was ineffective at preventing HIV infection among VOICE study participants. The rate of new HIV infections was the same (6 percent) in the group that applied the placebo gel daily as in the group that applied the tenofovir gel daily. Consequently, the DSMB recommended that the study discontinue evaluating tenofovir gel while continuing to evaluate tenofovir/emtricitabine tablets as designed. Notably, the DSMB found no safety concerns with any study product.

NIAID concurred with the DSMB’s recommendations.

To protect the integrity of the ongoing clinical trial, the study data continue to remain confidential to everyone except the DSMB until the study ends. Until that time, NIAID will not know or speculate about why tenofovir gel was ineffective in the VOICE study.
What happened to the study participants who had been taking oral tenofovir, applying tenofovir gel or applying placebo gel?

After the September 2011 DSMB meeting, the study team informed all study participants that oral tenofovir was being discontinued. Participants who had been randomly assigned to take the tenofovir tablets—roughly, 1,000 women—stopped using the product at their next scheduled clinic visit. Eight weeks later (in early December), they will return for a final set of tests and procedures, including HIV testing and counseling, before exiting the study. During this last study visit, the participants will receive information about where they can obtain HIV testing and counseling, contraception and other medical and support services as needed.

The study team is following the same procedures to inform all VOICE participants of the most recent development and to discontinue the tenofovir gel and placebo gel arms of the trial, which together involved roughly 2,000 women.

The women in the oral tenofovir and tenofovir gel groups who became HIV-infected and/or pregnant while participating in VOICE may continue to participate in MTN ancillary studies for those conditions (MTN 015 for those who acquired HIV infection during the VOICE study; MTN 016 for those who became pregnant).
How will the investigators know whether oral Truvada is effective at preventing HIV infection?
Once the investigators have collected all the study data, they will compare the number of women in each group who acquire HIV through exposure in their environment during the study to determine whether the oral Truvada regimen is significantly more effective than the oral placebo regimen in preventing HIV infection.
How and why is bone density being studied in VOICE?

In previous animal studies of tenofovir, very high doses of the drug (many times higher than the dose given to humans) were found to have an adverse effect on the animals’ bone health. In addition, an ongoing clinical study of HIV-infected men and women taking tenofovir as part of an antiretroviral drug treatment regimen has found measurable decreases in the density of spine and hip bones. Thus, the VOICE study investigators want to learn what effects, if any, oral tenofovir has on the bone density of healthy, HIV-uninfected women.

About 500 study participants who were originally assigned to take the tenofovir or the tenofovir/emtricitabine tablets at sites in Uganda and Zimbabwe have enrolled in a sub-study called VOICE B. The VOICE B participants are periodically undergoing specialized testing of bone-mineral density so investigators can monitor the bone health of these trial volunteers even more closely. Once they finish participating in VOICE, the women enrolled in VOICE B will be offered an opportunity to have their bone density checked 6 and 12 months after they stop taking their VOICE study product.

What impact, if any, will the VOICE findings have on NIAID’s other oral tenofovir and/or tenofovir-based microbicide research?
NIAID, its NIH partners and the MTN are considering the VOICE findings to date and how they may impact other tenofovir research studies that are in progress or in the planning stages. Each study will be examined in light of the new findings, with final decisions about the effect on each of these studies expected at a later time.

For more information about the VOICE study, see Clinical Trial of Antiretroviral-Based HIV Prevention Strategies for Women Now Under Way, Statement: NIH Modifies ‘VOICE’ HIV Prevention Study in Women, and Statement: NIH Discontinues Tenofovir Gel in ‘VOICE’ HIV Prevention Study.

Source: National Institute of Health

post break

Posted in Q & A | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

Cardiovascular Disease In Women

HEART DISEASE

 

HEART DISEASE is the number one cause of death in the United States, for women as well as men. The various forms of heart disease, which include coronary artery disease (CAD), high blood pressure, atherosclerosis, heart failure and heart attacks, are responsible for over 250,000 deaths a year among women. Research-based strategies to promote heart health – emphasizing lifestyle changes to improve diet, decrease cholesterol levels, increase exercise, maintain a healthy body weight, and avoid cigarette smoking – have contributed to the steady decrease in rate of death from heart disease for men since 1980. Unfortunately, the rate for women has remained largely unchanged.1

The National Institute of Nursing Research (NINR), one of the Institutes of the National Institutes of Health, supports research by nurse scientists that helps to improve the health and health care of individuals across the life span – from the management of patients during illness and recovery to the reduction of risks for disease and disability and the promotion of healthy lifestyles. Since its inception, NINR has placed a large focus on disease prevention, with particular attention devoted to the aspects of heart disease that relate specifically to women. Scientists funded by the NINR have investigated gender-related factors associated with heart disease risk assessment, heart attack symptoms, management, and recovery, and the effects of related cardiovascular conditions. The results of this research have shed new light on differences in how men and women experience and respond to heart and other cardiovascular diseases.

To help determine the role of family history in the risk of atherosclerosis for women, a research team at the Johns Hopkins Hospital, including NINR-funded researcher Dr. Diane Becker, studied 102 women who reported no current cardiac symptoms but had recently had a sibling hospitalized with premature CAD. The research team first determined the FRE scores for the women in the study. Although one-fifth of the women were current smokers, almost half were obese, and many had high blood pressure or were taking blood pressure medications, only two were considered high risk by the FRE. The women then underwent a special x-ray scan to determine the presence and extent of calcified atherosclerotic plaques within their coronary arteries. Forty of the women were found to have detectable coronary plaques, with 32 having elevated levels for their age and six showing severe and extensive coronary blockage.4

Each year, about 88,000 women ages 45-64, and about 372,000 women aged 65 and older, have a heart attack.

These findings show that women need to be more aware of their risks for heart disease, especially after menopause or in combination with other conditions or lifestyle factors. Also, adding an assessment of family history to the current screening procedures for women may help to identify those at risk for CAD at an early stage, when they would be able to benefit most from preventive measures such as dietary changes, weight loss, low-dose aspirin, or lipid-lowering medications.

Subtle Symptoms of Heart Attack

Most of the early research studies on the symptoms of heart attacks underrepresented women and focused primarily on older men, who generally reported feeling pain and pressure in their chest prior to an attack. Once a woman does seek treatment, health care professionals commonly misinterpret or underestimate the severity of her symptoms. This trend is also apparent when dealing with CAD, a frequent precursor to a heart attack.

In a series of preliminary studies, Dr. Jean McSweeney and her research team interviewed women who had recently suffered a heart attack about the symptoms they experienced both prior to and around the time they sought treatment. From these interviews, Dr. McSweeney developed the McSweeney Acute and Prodromal Myocardial Infarction Symptoms Survey (MAPMISS), a questionnaire to help women identify and describe their heart attack (also called myocardial infarction) symptoms.5

The research team later administered the MAPMISS questionnaire to over 500 female cardiac patients who had suffered a heart attack within the last 4-6 months. Virtually all the women recalled having early (prodromal) symptoms within the weeks prior to their attack. The most frequent symptoms were unusual fatigue and sleep disturbance. Other symptoms included shortness of breath, indigestion and anxiety. Less than a third of the women in the survey reported any early warning signs involving chest pain or discomfort. Acute symptoms experienced during the attack included shortness of breath, weakness, fatigue, cold sweats and dizziness. In contrast to most men, fewer than half of these women reported some degree of pressure, pain or tightness of the chest during the critical time of attack onset.6

In a separate study, Dr. Anne Rosenfeld interviewed 52 women who had been hospitalized after a recent heart attack about their experiences prior to seeking treatment. Common symptoms found in this group of women were pain of the jaw, arm, back, or chest, shortness of breath, fatigue, nausea, and sweating. However, most reported that they delayed seeking treatment for anywhere from 15 minutes to 2 weeks after their symptoms began.7

Further analysis of the interviews revealed two main groups of decision trajectories: knowing and managing. Women in the knowing group understood that their symptoms were serious and knew they would need help, even if they did not recognize that they were experiencing a heart attack. Some of these women sought treatment immediately, but others waited for a convenient time to go to the hospital, or delayed seeking treatment until a family member or co-worker insisted on calling for help. Many women in the managing group believed they were suffering from indigestion and tried to manage their pain with common analgesics, antacids, and other stomach remedies, or simply ignored their symptoms until the pain intensified and they were forced to seek treatment.8

During mid-life, a woman’s risk for heart disease starts to rise dramatically. In part, this is because a woman’s body stops producing estrogen.

A research team led by Dr. René Martin interviewed both men and women recovering from heart attacks to determine gender differences in early and acute symptoms. When initially seeking treatment, over half of the study participants understood that their symptoms and pain indicated a possible heart attack. Women were more likely than men to attribute their symptoms to gastrointestinal distress, stress, or anxiety, and to be surprised to receive a heart-related diagnosis. Those who recognized the cardiac nature of their symptoms sought treatment earlier than those who associated their symptoms with some other cause. While most of the participants reported that they had discussed their symptoms with a spouse or other support person, women were less likely than men to have their symptoms recognized as cardiac in nature, or to be advised to seek medical attention.9

These research results have helped to establish that both the early and the acute symptoms women experience related to a heart attack vary significantly from the classic chest pressure or pain described for men. The symptoms for women are more subtle and difficult to recognize, often appearing more like stomach problems or indigestion. Failure to recognize the meaning and severity of these symptoms could lead a woman suffering a heart attack to attribute her symptoms to other causes and delay seeking treatment.

Women in Recovery and Rehabilitation after a Heart Attack

The first year following a heart attack, women tend to have a higher rate of disability and death, and show poorer psychological adaptation, than men. In another study led by Dr. Martin, patients recovering from a heart attack were interviewed shortly after they were discharged from the hospital regarding their beliefs as to the causes of their illness. There were no differences noted between men and women in their medical histories prior to their hospitalization. Over one-third of those interviewed attributed their heart attacks to stress; other widely believed causes were diet, smoking, heredity and lack of exercise. Men tended to identify more causes than women, and were more likely to include poor diet, smoking or lack of exercise. These same patients were contacted for a three-month follow-up, at which time fewer than 20% of all participants reported efforts to lower their stress levels and women were less likely than men to report changes in diet or exercise.10

Dr. Sally Rankin recently led a study that followed 30 female heart attack survivors for a year following their attacks, in order to understand the factors that affect recovery and improve quality of life. Study participants completed questionnaires regarding quality of life at preset intervals – the first prior to leaving the hospital, then at one month, six months, and one year after hospital discharge. The quality of life scores, which included overall health, psychosocial and family functioning, mood, and social support, all improved by the end of the year. The greatest improvement, however, occurred in the area labeled “satisfaction with family life,” an area often viewed differently by women and men. Social support and mood were the best predictors of overall quality of life at one year for women; cardiac capacity, which indicates the ability to tolerate activity, was not found to have a significant impact.11

After a heart attack or coronary artery bypass graft (CABG) surgery to address CAD, a cardiac rehabilitation program consisting of regular exercise can significantly reduce mortality during recovery. Dr. Shirley Moore followed both recent female heart attack survivors and those who had undergone a CABG, to measure the frequency, quantity, persistence and intensity with which they followed their rehabilitation programs. She found that almost a quarter of the participants did not exercise at all, and only about half were still exercising at 3 months. Those who reported having fewer associated health conditions exercised with greater frequency and intensity. Those with more social support tended to have a higher rate of persistency, while a belief in the positive health benefits of exercise increased the amount of exercise undertaken by the participant.12

Taken together, these results indicate that women and men cardiac patients tend to differ in how they attribute the causes of their illness, which may influence their motivation to change their behavior and reduce the risks of re-occurrence after surviving a heart attack. Understanding the different dimensions of motivation, quality of life, activity levels, and exercise compliance could help clinicians improve rehabilitation programs for women after a cardiac event.

Women with Chronic Angina

Chronic angina is a long-term condition that often results from CAD, and two-thirds of the estimated 6 million Americans who suffer from this condition are women. In a survey of elderly CAD patients, Dr. Laura Kimble explored how chronic angina limits activity and diminishes quality of life. The research found that men and women experienced different forms of pain due to chronic angina. A significant percentage of both men and women described their pain as aching, heavy, exhausting or sharp; however, men reported a greater number of recent angina episodes, while women reported a greater intensity of pain which caused more limitation of activity. Also, a large proportion of women characterized their pain as hot/burning and tender, which was not seen in men. Although small, these variations could affect how health care personnel interpret the effects of chronic angina, possibly leading to different treatments for men and women.13, 14

 

Women and Peripheral Artery Disease (PAD)

Dr. Roberta Oka examined peripheral artery disease, a form of atherosclerosis which impairs circulation to the legs, for gender-related differences. PAD often causes intermittent claudication (leg pain associated with exertion) which limits activity and significantly decreases the quality of life for its sufferers. Severe cases of PAD could lead to leg ulcers and gangrene. Dr. Oka and her research team assessed lower leg circulation and measured the walking distance, activity tolerance, and quality of life in a group of elderly men and women suffering from mild to moderate PAD.

By taking action, older women and especially those who already have heart disease can reduce their risk of developing heart-related problems.

Over three-quarters of those polled reported engaging in regular exercise and fewer than 10% were smokers. However, many reported common related medical conditions including high blood pressure, high cholesterol, diabetes, chronic angina, and CAD. As part of the study, the participants underwent a graded exercise treadmill test. The walking distance before the onset of claudication was not significantly different between men and women, although the men achieved a greater total distance. In a quality of life questionnaire, the women reported worse physical functioning, more body pain and a poorer mood state.15 Even though PAD is more common in men, the results of this study indicated that women with PAD might suffer a greater decrease in their activity tolerance and quality of life.

 

Conclusion:

Research supported by the NINR has contributed to the growing body of evidence indicating that women’s risks for, symptoms of, and responses to heart and cardiovascular disease vary widely from those of men. Women’s symptoms tend to be more subtle and less predictable, leading to potentially detrimental outcomes. Women often underestimate the danger of cardiovascular disease, and may fail to take preventive measures, heed warning signs, or seek treatment for symptoms. Even after a heart attack or cardiac surgery, their compliance with rehabilitation efforts may be insufficient.

About 6 million American women have coronary heart disease.

Understanding the complexity of a woman’s symptoms of heart and cardiovascular disease could greatly assist nurses and other health care professionals in designing interventions both to promote cardiac health awareness and to decrease treatment delay – key components in survival and recovery. Nursing care also needs to focus more on teaching heart-protective lifestyle habits, cardiac symptom recognition and response, and cardiac recovery and rehabilitation, in order to improve the future of women at risk for or suffering from heart disease.

References

1. American Heart Association, 2004. Retrieved January 25, 2006, from http://www.americanheart.org/presenter.jhtml?identifier=3000941

2. Sparks EA, Frazier LQ. Heritable cardiovascular disease in women. Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2002; 31: 217-228.

3. Tobacco Information and Prevention Source (TIPS). 2004. Adult Cigarette Smoking in the United States: Current Estimates. National Center for Chronic Disease Prevention and Health Promotion. Retrieved January 25, 2006, from: http://www.cdc.gov/tobacco/factsheets/AdultCigaretteSmoking_FactSheet.htm

4. Michos ED, Vasamreddy CR, Becker DM, Yanek LR, Moy TF, Fishman EK, Becker LC, Blumenthal RS. Women with a low Framingham risk score and a family history of premature coronary heart disease have a high prevalence of subclinical coronary atherosclerosis. American Heart Journal. 2005; 150(6): 1276-1281.

5. McSweeney JC, O’Sullivan P, Cody M, Crane PB. Development of the McSweeney Acute and Prodromal Myocardial Infarction Symptom Survey. Journal of Cardiovascular Nursing. 2004; 19: 58-67.

6. McSweeney JC, Cody M, O’Sullivan P, Elberson K, Moser DK, Garvin BJ. Women’s early warning symptoms of acute myocardial infarction. Circulation. 2003; 108: 2619-2623.

7. Rosenfeld AG. Treatment-seeking delay among women with acute myocardial infarction: decision trajectories and their predictors. Nursing Research. 2004;

53: 225-236.

8. Rosenfeld AG, Lindauer A, Darney BG. Understanding treatment-seeking delay in women with acute myocardial infarction: descriptions of decision-making patterns. American Journal of Critical Care. 2005; 14 (4): 285-293.

9. Martin R, Lemos K, Rothrock N, Bellman SB, Russell D, Tripp-Reimer T, Lounsbury P, and Gordon E. Gender disparities in common sense models of illness among myocardial infarction victims. Health Psychology. 2004; 23 (4): 345-353.

10. Martin R, Johnsen EL, Bunde J, Bellmen SB, Rothrock NE, Weinrib A, Lemos K. Gender differences in patients’ attributions for myocardial infarction: implications for adaptive health behaviors. International Journal of Behavioral Medicine. 2005; 12 (1): 39-45.

11. Rankin SH, Fukuoka Y. Predictors of quality of life in women 1 year after myocardial infarction. Progress in Cardiovascular Nursing. 2003; 18: 6-12, 62.

12. Moore SM, Dolansky MA, Ruland CM, Pashkow FJ, Blackburn GG. Predictors of women’s exercise maintenance after cardiac rehabilitation. Journal of Cardiopulmonary Rehabilitation. 2003; 23: 40-49.

13. Kimble LP, Dunbar SB, Weintraub WS, McGuire DB, Fazio S, De AK, Strickland O. The Seattle Angina Questionnaire: reliability and validity in women with chronic stable angina. Heart Disease. 2002; 4: 206-211.

14. Kimble LP, McGuire DB, Dunbar SB, Fazio S, De A, Weintraub WS, Strickland OS. Gender differences in pain characteristics of chronic stable angina and perceived physical limitation in patients with coronary artery disease. Pain. 2003; 101: 45-53.

15. Oka RK, Szuba A, Giacomini JC, Cooke JP. Gender difference in perception of PAD: a pilot study. Vascular Medicine. 2003; 8: 89-94.

Factors That Increase Women’s Heart Disease Risk

Those beyond your control:

Family history of early heart disease Being 55 or older

Those you can take action against:

Smoking – about 21.2 million women smoke.

High blood pressure – 33 percent of women have hypertension, the condition’s medical name; uncontrolled high blood pressure can lead to heart failure, which affects about 2.5 million women. High blood cholesterol – about 56.5 million women have high total cholesterol.

Overweight/obesity – 62 percent of women are overweight, including about 33 percent who are obese. Physical inactivity – more women than men are

physically inactive, with 41 percent of women engaging in no leisure-time physical activity and more than 60 percent of women do not meet the recommended amount of at least 30 minutes a day of moderately intense physical activity, such as brisk walking.

Diabetes – nearly 7 million women have been diagnosed with diabetes and another 3 million are undiagnosed.

These research findings from the NINR show that women experience a wide range of symptoms that may indicate a heart attack, and often delay seeking treatment for a variety of reasons. If you are a woman and you begin to feel fatigue, shortness of breath, anxiety, weakness, dizziness, or a cold sweat, even in the absence of chest pain or pressure, you may be having a heart attack. You should contact your health care provider or call 911 immediately.

The NINR is part of the National Institutes of Health (NIH), the biomedical research arm of the federal government. NIH is an agency of the U.S. Department of Health and Human Services. To learn more about the NINR and nursing research, please visit the NINR website: http://ninr.nih.gov/ninr/

Other sources of information about women and heart disease:

National Heart, Lung, and Blood Institute

www.hearttruth.gov, 301-592-8573, TTY: 240-629-3255

Office on Women’s Health, DHHS National Women’s Health Information Center

www.WomensHealth.gov, 1-800-994-WOMAN, TDD: 1-888-220-5446

American Heart Association

www.americanheart.org, 1-888-MY HEART

WomenHeart: the National Coalition for Women with Heart Disease

www.womenheart.org, 202-728-7199 

 

Source: NATIONAL INSTITUTE OF NURSING RESEARCH

post break

Posted in Studies | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

General Information About Breast Cancer

Breast cancer is a disease in which malignant (cancer) cells form in the tissues of the breast.

The breast is made up of lobes and ducts. Each breast has 15 to 20 sections called lobes, which have many smaller sections called lobules. Lobules end in dozens of tiny bulbs that can produce milk. The lobes, lobules, and bulbs are linked by thin tubes called ducts.

Drawing of female breast anatomy showing the lymph nodes, nipple, areola, chest wall, ribs, muscle, fatty tissue, lobe, and ducts.

Anatomy of the female breast. The nipple and areola are shown on the outside of the breast. The lymph nodes, lobes, lobules, ducts, and other parts of the inside of the breast are also shown:

Each breast also has blood vessels and lymph vessels. The lymph vessels carry an almost colorless fluid called lymph. Lymph vessels lead to organs called lymph nodes. Lymph nodes are small bean-shaped structures that are found throughout the body. They filter lymph and store white blood cells that help fight infection and disease. Clusters of lymph nodes are found near the breast in the axilla (under the arm), above the collarbone, and in the chest.

See the following PDQ summaries for more information about breast cancer:

  • Breast Cancer Screening

What is screening?

Screening is looking for cancer before a person has any symptoms. This can help find cancer at an early stage. When abnormal tissue or cancer is found early, it may be easier to treat. By the time symptoms appear, cancer may have begun to spread.

Scientists are trying to better understand which people are more likely to get certain types of cancer. They also study the things we do and the things around us to see if they cause cancer. This information helps doctors recommend who should be screened for cancer, which screening tests should be used, and how often the tests should be done.

It is important to remember that your doctor does not necessarily think you have cancer if he or she suggests a screening test. Screening tests are given when you have no cancer symptoms.

If a screening test result is abnormal, you may need to have more tests done to find out if you have cancer. These are called diagnostic tests.

  • Breast Cancer Treatment
  • Genetics of Breast and Ovarian Cancer

Breast cancer is the second most common type of cancer in American women.

Women in the United States get breast cancer more than any other type of cancer except skin cancer. The number of new cases of breast cancer has stayed about the same since 2003. Breast cancer is second to lung cancer as a cause of cancer death in American women. However, deaths from breast cancer have decreased a little bit every year for the past several years. Breast cancer also occurs in men, but the number of new cases is small.

Age and health history can affect the risk of developing breast cancer.

Anything that increases your chance of getting a disease is called a risk factor. Having a risk factor does not mean that you will get cancer; not having risk factors doesn’t mean that you will not get cancer. People who think they may be at risk should discuss this with their doctor. Risk factors for breast cancer include the following:

  • Older age.
  • Menstruating at an early age.
  • Older age at first birth or never having given birth.
  • A personal history of breast cancer or benign (noncancer) breast disease.
  • A mother or sister with breast cancer.
  • Treatment with radiation therapy to the breast/chest.
  • Breast tissue that is dense on a mammogram.
  • Taking hormones such as estrogen and progesterone.
  • Drinking alcoholic beverages.
  • Being white.

NCI’s Breast Cancer Risk Assessment Tool uses a woman’s risk factors to estimate her risk for breast cancer during the next five years and up to age 90. This online tool is meant to be used by a health care provider. For more information on breast cancer risk, call 1-800-4-CANCER.

Breast cancer is sometimes caused by inherited gene mutations (changes).

The genes in cells carry the hereditary information that is received from a person’s parents. Hereditary breast cancer makes up approximately 5% to 10% of all breast cancer. Some altered genes related to breast cancer are more common in certain ethnic groups.

Women who have an altered gene related to breast cancer and who have had breast cancer in one breast have an increased risk of developing breast cancer in the other breast. These women also have an increased risk of developing ovarian cancer, and may have an increased risk of developing other cancers. Men who have an altered gene related to breast cancer also have an increased risk of developing this disease. For more information, see the PDQ summary on Male Breast Cancer Treatment.

Tests have been developed that can detect altered genes. These genetic tests are sometimes done for members of families with a high risk of cancer. See the following PDQ summaries for more information:

Possible signs of breast cancer include a lump or change in the breast.

Breast cancer may cause any of the following signs and symptoms. Check with your doctor if any of the following problems occur:

  • A lump or thickening in or near the breast or in the underarm area.
  • A change in the size or shape of the breast.
  • A dimple or puckering in the skin of the breast.
  • A nipple turned inward into the breast.
  • Fluid, other than breast milk, from the nipple, especially if it’s bloody.
  • Scaly, red, or swollen skin on the breast, nipple, or areola (the dark area of skin that is around the nipple).
  • Dimples in the breast that look like the skin of an orange, called peau d’orange.

Other conditions that are not breast cancer may cause these same symptoms.

Tests that examine the breasts are used to detect (find) and diagnose breast cancer.

A doctor should be seen if changes in the breast are noticed. The following tests and procedures may be used:

  • Physical exam and history: An exam of the body to check general signs of health, including checking for signs of disease, such as lumps or anything else that seems unusual. A history of the patient’s health habits and past illnesses and treatments will also be taken.
  • Mammogram: An x-ray of the breast.

Mammography of the right breast.

  • Ultrasound exam: A procedure in which high-energy sound waves (ultrasound) are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissues called a sonogram. The picture can be printed to be looked at later.
  • MRI (magnetic resonance imaging): A procedure that uses a magnet, radio waves, and a computer to make a series of detailed pictures of areas inside the body. This procedure is also called nuclear magnetic resonance imaging (NMRI).
  • Blood chemistry studies: A procedure in which a blood sample is checked to measure the amounts of certain substances released into the blood by organs and tissues in the body. An unusual (higher or lower than normal) amount of a substance can be a sign of disease in the organ or tissue that makes it.
  • Biopsy: The removal of cells or tissues so they can be viewed under a microscope by a pathologist to check for signs of cancer. If a lump in the breast is found, the doctor may need to remove a small piece of the lump. Four types of biopsies are as follows:
    • Excisional biopsy: The removal of an entire lump of tissue.
    • Incisional biopsy: The removal of part of a lump or a sample of tissue.
    • Core biopsy: The removal of tissue using a wide needle.
    • Fine-needle aspiration (FNA) biopsy: The removal of tissue or fluid, using a thin needle.

If cancer is found, tests are done to study the cancer cells.

Decisions about the best treatment are based on the results of these tests. The tests give information about:

  • how quickly the cancer may grow.
  • how likely it is that the cancer will spread through the body.
  • how well certain treatments might work.
  • how likely the cancer is to recur (come back).

Tests include the following:

  • Estrogen and progesterone receptor test: A test to measure the amount of estrogen and progesterone (hormones) receptors in cancer tissue. If there are more estrogen and progesterone receptors than normal, the cancer may grow more quickly. The test results show whether treatment to block estrogen and progesterone may stop the cancer from growing.
  • Human epidermal growth factor type 2 receptor (HER2/neu) test: A laboratory test to measure how many HER2/neu genes there are and how much HER2/neu protein is made in a sample of tissue. If there are more HER2/neu genes or higher levels of HER2/neu protein than normal, the cancer may grow more quickly and is more likely to spread to other parts of the body. The cancer may be treated with drugs that target the HER2/neu protein, such as trastuzumab (Herceptin) and lapatinib (Tykerb).
  • Multigene tests: Tests in which samples of tissue are studied to look at the activity of many genes at the same time. These tests may help predict whether cancer will spread to other parts of the body or recur (come back).
    • Oncotype DX: This test helps predict whether stage I or stage II breast cancer that is estrogen receptor positive and node-negative will spread to other parts of the body. If the risk of the cancer spreading is high, chemotherapy may be given to lower the risk.
    • MammaPrint: This test helps predict whether stage I or stage II breast cancer that is node-negative will spread to other parts of the body. If the risk of the cancer spreading is high, chemotherapy may be given to lower the risk.

Certain factors affect prognosis (chance of recovery) and treatment options.

The prognosis (chance of recovery) and treatment options depend on the following:

  • The stage of the cancer (the size of the tumor and whether it is in the breast only or has spread to lymph nodes or other places in the body).
  • The type of breast cancer.
  • Estrogen receptor and progesterone receptor levels in the tumor tissue.
  • Human epidermal growth factor type 2 receptor (HER2/neu) levels in the tumor tissue.
  • Whether the tumor tissue is triple-negative (cells that do not have estrogen receptors, progesterone receptors, or high levels of HER2/neu).
  • How fast the tumor is growing.
  • How likely the tumor is to recur (come back).
  • A woman’s age, general health, and menopausal status (whether a woman is still having menstrual periods).
  • Whether the cancer has just been diagnosed or has recurred (come back).

Source: (NCI) National Cancer Institute

post break

Posted in What You Need To Know | Tagged , , , , , , , , , , , , , , , , , , , | Comments Off

Genetically Informed Approaches to Lung Cancer’s Complexity

“I think it’s an exciting time now, because if we can influence early diagnosis and prevention of lung cancer, and care of discovered lung cancer, we could actually make a major change to total cancer mortality in the United States. [Already] the total cancer mortality has gone down over the past five to ten years mainly due to decreases in cigarette smoking.”

-John Minna M.D. University of Texas Southwestern Medical Center

An estimated 220,000 individuals were diagnosed with some form of lung cancer in 2010. It is the leading cause of cancer-related death, with more than 157,000 predicted deaths in 2010.

Smoking is far and away the most important risk factor for lung cancer. It is evident that risk increases with the number of cigarettes smoked per day and the duration of smoking. Deaths from lung cancer have been decreasing in men since 1990, but have been stable in women since 2003 after continuously rising for several decades. These trends reflect historical differences in smoking between men and women, and the decrease in smoking rates over the past 40 years.

The cancer community is poised to take advantage of the convergence of genetic information, appropriate screening techniques, and new targeted therapies for lung cancer. For the enormous number of individuals who will face a diagnosis of lung cancer this year, any brighter outlook is most welcome.

Lung Cancer is Not a Single Disease

When we say lung cancer, we are actually referring to four different subtypes. Three subtypes are non-small cell lung carcinomas, or NSCLC: adenocarcinoma, squamous cell carcinoma, and large cell carcinoma; the fourth subtype is small cell carcinoma. This first-level classification is likely to be the start of solving a complicated challenge of linking diagnostic characteristics to the most effective treatments.

NCI-supported researchers are beginning to uncover genetic drivers of these four subtypes and applying this molecular knowledge for clinical benefit. However, it is clear that the best in diagnostic technologies and therapeutic advances will be needed to make significant progress in treating this very complex collection of diseases. Ideally, this will be complemented by down-ward trends in smoking rates, which is the most effective way to reduce the burden of lung cancer.

Crizotinib: A Promising New Targeted Drug

There are currently several mutations that are known to exist in lung cancer, including EGFR and RAS gene mutations in non-small cell lung cancer. As with melanoma and some other cancers, BRAFgene mutations have also been found in lung cancers.

In 2007, researchers identified a genetic target known as a gene translocation, or movement of a gene fragment from one chromosomal location to another. The translocated gene, EML4-ALK—found in 5 percent of NSCLC patients—can be acted on by crizotinib, a promising new drug with minimal side effects. Crizotinib acts by blocking the ALK kinase, believed to promote tumor growth. Results from this phase I trial showed that more than half of treated patients experienced tumor shrinkage while 33 percent had their tumors stabilize.

The development of crizotinib was made possible through molecular tumor characterization that was conducted at NCI-designated Cancer Centers. The drug was first tested against anaplastic large-cell lymphoma as well as on neuroblastoma and NSCLC cells grown in the laboratory. Preliminary results of the phase I trial were so promising that a trial testing crizotinib in children with neuroblastoma was launched less than six months after the release of the results.

While efforts to further decrease smoking rates are critical, there is also great opportunity to utilize molecular and genetic information to significantly improve the treatment options available to patients diagnosed with lung cancer. This will require continued investigation into the biology of the various types of lung cancer and coordination between laboratory and clinical researchers to optimize existing treatment strategies and develop new ones. Crizotinib received FDA approval in 2011.

 

Source: National Cancer Institute

post break

Posted in What You Need To Know | Tagged , , , , , , , , , , , , , , , , , , , , , , | Comments Off

HPV Vaccine – Questions & Answers

Why are HPV vaccines needed?

HPV vaccines prevent serious health problems, such as cervical cancer and other, less common cancers, which are caused by HPV (human papillomavirus). In addition to cancer, HPV can also cause other health problems, such as genital warts

HPV is a common virus that is easily spread by skin-to-skin contact during sexual activity with another person. It is possible to have HPV without knowing it, so it is possible to unknowingly spread HPV to another person. Safe, effective vaccines are available to protect females and males against some of the most common types of HPV and the health problems that the virus can cause.
How common are the health problems caused by HPV?
HPV is the main cause of cervical cancer in women. There are about 11,000 new cervical cancer cases each year in the United States. Cervical cancer causes about 4,000 deaths in women each year in the United States.
About 1 in 100 sexually active adults in the United States have genital warts at any one time.
What HPV vaccines are available in the United States?
Two HPV vaccines are licensed by the FDA and recommended by CDC. These vaccines are Cervarix (made by GlaxoSmithKline) and Gardasil (made by Merck).
How are the two HPV vaccines similar?
• Both vaccines are very effective against HPV types 16 and 18, which cause most cervical cancers. So both vaccines prevent cervical cancer in women.
• Both vaccines are very safe.
• Both vaccines are made with very small parts of the human papillomavirus (HPV) that cannot cause infection.
• Both vaccines are given as shots and require 3 doses.
How are the two HPV vaccines different?
• Only one of the vaccines (Gardasil) protects against HPV types 6 and 11 the types that cause most genital warts in females and males.
• Only one of the vaccines (Gardasil) has been tested and licensed for use in males.
• Only one of the vaccines (Gardasil) has been tested and shown to protect against cancers of the vulva, vagina, and anus.
• The vaccines have different adjuvants—a substance that is added to the vaccine to increase the body’s immune response.
Who should get HPV vaccine?
Cervarix and Gardasil are licensed, safe, and effective for females ages 9 through 26 years. CDC recommends that all girls who are 11 or 12 years old get the 3 doses (shots) of either brand of HPV vaccine to protect against cervical cancer. Gardasil also protects against most genital warts, as well as some cancers of the vulva, vagina, and anus. Girls and young women ages 13 through 26 should get all 3 doses of an HPV vaccine if they have not received all doses yet.
Gardasil is also licensed, safe, and effective for males ages 9 through 26 years. Boys and young men may choose to get this vaccine to prevent genital warts, and anal cancer.
People who have already had sexual contact before getting all 3 doses of an HPV vaccine might still benefit if they were not infected before vaccination with the HPV types included in the vaccine they received. The best way to be sure that a person gets the most benefit from HPV vaccination is to complete all three doses before sexual activity begins.
Why is Gardasil not on the immunization schedule for boys and men?
CDC did not add this vaccine to the recommended immunization schedules for males in these age groups because studies suggest that the best way to prevent the most disease due to HPV is to vaccinate as many girls and women as possible. Parents of boys can decide if Gardasil is right for their sons by talking with their sons’ health care providers. Young men can also discuss this vaccine with their doctors.
Why is HPV vaccine recommended at ages 11 or 12 years?
For the HPV vaccine to work best, it is very important to get all 3 doses (shots) before being exposed to HPV. Someone can be infected with HPV the very first time they have sexual contact with another person. It is also possible to get HPV even if sexual contact only happens one time.
How does getting HPV vaccine at ages 11 or 12 fit with other health recommendations?
Doctors recommend health check-ups for preteens and teens. The first dose of an HPV vaccine should be given to girls aged 11 or 12 years during a health check-up. The first dose of Gardasil can also be given to boys during their check-ups. Three other vaccines are recommended for preteens and teens. During one visit, either HPV vaccine can be given safely with these other preteen and teen vaccines. Check-ups during the preteen and teen years are also times when older kids and their parents can talk to their providers about other ways to stay healthy and safe.
What is the recommended schedule (or timing) of the 3 HPV doses (shots)?
For both females and males,