Women's Health First

Creating An AIDS-Free Generation Remarks

Posted on December 2, 2011 by admin

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

Posted in What You Need To Know | Tagged AIDS-Free Generation, Bill & Melinda Gates Foundation, Capital Care Network, Centers for Disease Control and Prevention, Clinton Foundation, Ellen DeGeneres, Eric Goosby, Francis Collins, Global AIDS Coordinator, Global Fund, Harold Varmus, Hillary Rodham Clinton, HIV/AIDS, John Gallin, Lois Quam, Mark Dybul, Michel Sidibe, National Institutes of Health, NIH, Nora Volkow, pandemic, PEPFAR, Raj Shah, Saharan Africa, Tom Frieden, UNAIDS | Comments Off

The VOICE HIV Prevention Study

Posted on November 30, 2011 by admin

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

Posted in Q & A | Tagged antiretrovira, Capital Care Network, CAPRISA, CONRAD, DSMB, emtricitabine, Eunice Kennedy Shriver National Institute of Child Health and Human Development, HIV Prevention Study, HIV transmission, HIV-negative women, investigational vaginal microbicide gel, Jeanne Marrazzo, Mike Chirenje, MTN-003, National Institute of Allergy and Infectious Disease, National Institute of Mental Health, NIAID-sponsored iPrEx, NICHD, NIH, NIMH, Phase IIb clinical trial, pre-exposure prophylaxis, PrEP, tenofovir, Truvada, Viread, VOICE study | Comments Off

Cardiovascular Disease In Women

Posted on November 8, 2011 by admin

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.¹⁵Even 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

Posted in Studies | Tagged atherosclerosis, CABG, CAD, Capital Care Network, Cardiovascular Disease, Chronic Angina, claudication, coronary artery bypass graft, coronary artery disease, coronary blockage, Dr. Anne Rosenfeld, Dr. Diane Becker, Dr. Jean McSweeney, Dr. René Martin, Dr. Roberta Oka, Dr. Sally Rankin, estrogen, FRE, heart disease, heart failure and heart attacks, High blood pressure, MAPMISS, myocardial infarction, National Institute of Nursing Research, NINR, prodromal, Prodromal Myocardial Infarction Symptoms Survey | Comments Off

General Information About Breast Cancer

Posted on November 7, 2011 by admin

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

Posted in What You Need To Know | Tagged axilla, Breast Cancer, Capital Care Network, ducts, estrogen recepto, HER2/neu protein, Herceptin, lapatinib, lobes, lobules, lymph nodes, malignant cells, MammaPrint, most common type of cancer, Multigene tests, National Cancer Institute, NCI, Oncotype DX, trastuzumab, Tykerb | Comments Off

Genetically Informed Approaches to Lung Cancer’s Complexity

Posted on November 6, 2011 by admin

“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

Posted in What You Need To Know | Tagged adenocarcinoma, ALK kinase, appropriate screening techniques, BRAFgene, Capital Care Network, Crizotinib, EGFR, EML4-ALK, FDA approval, genetic information, large cell carcinoma, lung cancer, melanoma, National Cancer Institute, neuroblastoma, new targeted therapies for lung cancer, non-small cell lung carcinomas, NSCLC, RAS, small cell carcinoma, Smoking, squamous cell carcinoma, translocation | Comments Off

HPV Vaccine – Questions & Answers

Posted on November 4, 2011 by admin

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, 3 doses (shots) are needed. CDC recommends that the second dose be given one to two months after the first, and the third dose be given six months after the first dose.
Will someone be protected against HPV-related diseases if they do not get all 3 doses?
No studies so far have shown whether or not 1 or 2 doses protect as well as getting 3 doses, so it is very important to get all 3 doses.
Are the HPV vaccines safe and effective?
FDA has licensed the vaccines as safe and effective. Both vaccines were tested in thousands of people around the world. These studies showed no serious safety concerns. Common, mild adverse events reported during these studies include pain where the shot was given, fever, dizziness, and nausea. As with all vaccines, CDC and FDA continue to monitor the safety of these vaccines very carefully.
Do people faint after getting HPV vaccines?
People faint for many reasons. Some people may faint after getting any vaccine, including HPV vaccines. Falls and injuries can occur after fainting. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries.
Can HPV vaccines treat HPV infections, cancers, or warts?
HPV vaccines will not treat or get rid of existing HPV infections. Also, HPV vaccines do not treat or cure health problems (like cancer or warts) caused by an HPV infection that occurred before vaccination.
How important is it to get HPV vaccine?
The HPV vaccines are important tools to prevent cervical cancer and genital warts. As with all vaccines, the benefits outweigh potential risks.
Are there other HPV diseases that the two vaccines may prevent?
Studies have shown that Gardasil prevents some cancers of the vagina, vulva and anus which like cervical cancer, can be caused by HPV types 16 and 18. Studies of Cervarix have not looked at protection against cancers of vagina, vulva and anus.
Published studies have not looked at other health problems that might be prevented by HPV vaccines. It is possible that HPV vaccines will also prevent some cancers of the penis and some cancers of the oropharynx (head and neck cancers that are located around the back of the tongue and tonsils) due to HPV 16. Gardasil might prevent recurrent respiratory papillomatosis (RRP), a rare condition caused by HPV 6 or 11 in which warts grow in the throat.
Why aren’t HPV vaccines recommended for people older than 26?
Both vaccines were studied in thousands of people from 9 through 26 years old and found to be safe and effective for these ages. The FDA will consider licensing HPV vaccines for other ages if new studies show that this would also be safe and effective.
Should pregnant women be vaccinated?
Pregnant women are not included in the recommendations for HPV vaccines. Studies show neither vaccine caused problems for babies born to women who got the HPV vaccine while they were pregnant. Getting the HPV vaccine when pregnant is not a reason to consider ending a pregnancy. But, to be on the safe side until even more is known, a pregnant woman should not get any doses of either HPV vaccine until her pregnancy is completed.
What should a woman do if she realizes she received HPV vaccination while pregnant?
If a woman realizes that she got any shots of an HPV vaccine while pregnant, she should do two things:
• Wait until after her pregnancy to finish the remaining HPV vaccine doses.
• Report the vaccination to the appropriate pregnancy registry. There are pregnancy registries to help us learn more about how pregnant women respond to each of the vaccines. So, if a woman realizes that she got any shots of either HPV vaccine while pregnant, she should work with her health care provider to report it to the appropriate pregnancy registry:
○ The toll-free number for Gardasil is 800-986-8999
○ The toll-free number for Cervarix is 888-452-9622
Will HPV vaccination be covered by health insurance?
Most health insurance plans cover recommended vaccines. But there may be a lag time after a vaccine is recommended before it gets added to insurance plans. Some insurance plans may not cover any or all vaccines. Check with your insurance provider to see if the cost of the vaccine is covered before going to the doctor.
How can my child get an HPV vaccine if I don’t have insurance?
The Vaccines for Children (VFC) program helps families of eligible children who might not otherwise have access to vaccines. The program provides vaccines at no cost to doctors who serve eligible children. Children younger than 19 years of age are eligible for VFC vaccines if they are Medicaid-eligible, American Indian, or Alaska Native or have no health insurance. “Underinsured” children who have health insurance that does not cover vaccination can receive VFC vaccines through Federally Qualified Health Centers or Rural Health Centers. Parents of uninsured or underinsured children who receive vaccines at no cost through the VFC Program should check with their health care providers about possible administration fees that might apply. These fees help providers cover the costs that result from important services like storing the vaccines and paying staff members to give vaccines to patients. For more information about the VFC program, visit the VFC Program web site.

Source:CDC

Posted in Q & A | Tagged anus, Capital Care Network, CDC, Centers fo Disease Control and Prevention, Cervarix, cervical cancer, FDA, Gardasil, genital warts, GlaxoSmithKline, HPV, HPV vaccines, human papillomavirus, Merck, oropharynx, skin-to-skin contact, vaccines, Vaccines for Children, vagina, VFC, vulva | Comments Off

Menstruation and the Menstrual Cycle

Posted on September 17, 2011 by admin

What is the menstrual cycle?
The menstrual cycle is the process by which a woman’s body gets ready for the chance of a pregnancy each month. The average menstrual cycle is 28 days from the start of one to the start of the next, but it can range from 21 days to 35 days.

In the beginning of the menstrual cycle, levels of estrogen rise, causing the lining of the uterus to grow and get thicker. An egg starts to mature in one of the ovaries. Around the middle of the cycle, the egg leaves the ovary, a process called ovulation.

The egg begins to travel down the fallopian tubes to the uterus. If the egg becomes fertilized by a sperm cell and attaches to the uterus, the woman becomes pregnant. If not, the uterus does not need the extra thick lining and it begins to shed.

This shedding of the uterine lining through the vagina is menstruation.

What is menstruation?

Menstruation is the part of a woman’s monthly menstrual cycle in which blood and tissue are discharged from the vagina. It is also commonly called a period or menstrual period. Most menstrual periods last from three to five days. In the United States, most girls start menstruating at age 12, but girls can start menstruating between the ages of 8 and 16.

What are the signs of menstruation?

Bleeding from the vagina is the primary sign of menstruation.

Some women have other symptoms around the time of menstruation, including:

Cramping, bloating, and sore breasts
Food cravings
Mood swings and irritability
Headache and fatigue

If these symptoms are severe, it might be a sign of premenstrual syndrome (PMS). PMS usually occurs one or two weeks before menstruation. PMS may affect a woman of any age who has menstrual periods. If the symptoms disrupt your lifestyle, you may want to seek medical care.

What if I have a problem with my menstrual periods?

A stop in menstrual periods (called amenorrhea), or other menstrual irregularities could be a sign that something is wrong. Menstrual irregularities can mean bleeding between your periods, skipping a period, or having very heavy menstrual periods. It is important to tell your health care provider about these symptoms.

Are there treatments for painful menstruation?

Placing a heating pad on the abdomen and over-the-counter pain relievers may help lessen the symptoms. It is important to tell your health care provider if you have severe cramping and pain or other symptoms, during menstruation.

The Normal Menstrual Cycle

In general, a woman’s reproductive health involves her:

Hypothalamus (pronounced high-poe-THAL-amus)—part of the brain that functions as the main control for the body’s reproductive system. The hypothalamus works like a thermostat in a furnace, in that it controls the levels of different hormones and other chemicals in the body. If the hypothalamus detects that there is too little of a hormone in the body, it orders the body to make more.

Pituitary (pronounced pitt-OO-ih-terry) gland—the body’s master gland. The pituitary sends out hormones, or chemical signals to control the other glands in the body. The pituitary gets orders from the hypothalamus about what the body needs.

Ovaries—the source of eggs in a woman’s body. The ovaries have follicles, which are tiny, fluid-filled sacs that hold the eggs. The ovaries also make hormones that help to maintain a woman’s health, such as estrogen, progesterone, and testosterone. The ovaries receive the chemical signals from the pituitary and respond by making certain hormones. In POF, the ovaries stop working correctly in both their egg production role, and in their hormone production role.

Uterus—where a woman carries a baby, also called the “womb.” The uterus has different layers; its innermost layer or lining is called the endometrium—endo means “inside” and metrium (pronounced MEE-tree-um) means “womb.” The endometrium functions as a bed for an embryo when a woman is pregnant. If no pregnancy occurs during the cycle, then the endometrium is shed as a menstrual flow, or a period, and the cycle starts all over again.

These parts interact with one another to coordinate a woman’s monthly menstrual cycle.

The hypothalamus keeps track of the level of estradiol (pronounced ess-trah-DYE-awl) in the body. Estradiol is the natural estrogen that a woman’s body makes, so we’ll call it estrogen from now on.

When the level gets low, the hypothalamus sends an order to the pituitary gland telling it that the body needs more estrogen.

The pituitary gets the order and responds by sending out follicle stimulating hormone (FSH), a hormone that causes the follicles on the ovary to grow and mature. Mature follicles make estrogen and other substances, such as inhibin. The pituitary continues to make FSH until the mature ovarian follicles make enough estrogen. If the follicles don’t make enough estrogen, the level of FSH goes even higher.

When the level of estrogen gets high enough, the hypothalamus and pituitary know that there is a mature egg in one of the follicles. To get this egg to the uterus so that it can be fertilized, the pituitary sends out a large burst of luteinizing hormone (LH). LH breaks open the mature follicle to release the egg, which allows it to move toward the uterus. The level of LH is only high during the time an egg is being released. This LH burst is the basis for home ovulation detection kits. Because LH may be high throughout much of the menstrual cycle in women who have POF, home ovulation detection kits are unreliable in these women.

The empty follicle is then transformed into a yellowish, corpus luteum (pronounced CORE-puss loo-tee-um). Corpus means “body” and luteum means “yellow.” The corpus luteum makes progesterone, the hormone that prepares the uterus for pregnancy.

Increased levels of progesterone cause the endometrium to change in preparation for pregnancy, should it occur. Once the endometrium is properly prepared, it can support an embryo and allow the embryo to grow.

If the egg is fertilized, it sends out a hormone called HCG to let the body know that it’s there. HCG causes the corpus luteum to continue to make progesterone, the hormone needed for pregnancy. Pregnancy tests measure the level of HCG. If HCG is present, then it’s likely that a woman is pregnant.

If there is no signal, that is, no HCG is present because the egg wasn’t fertilized, the corpus luteum stops making progesterone. Without progesterone, the endometrium starts to break down, and the woman’s body sheds it as her period.

Source:NIH

Posted in What You Need To Know | Tagged Amenorrhea, bloating, Capital Care Network, capitalcarenetwork.com, corpus luteum, Cramping, Endometrium, estrogen, Fallopian Tubes, HCG, Hypothalamus, irritability, Menstrual Cycle, Menstruation, Mood swings, Myometrium, ovaries, ovulation, Pituitary, PMS, POF, premenstrual syndrome, progesterone, sore breasts, testosterone, uterus, vagina | Comments Off

Amenorrhea

Posted on September 11, 2011 by admin

Amenorrhea

What is amenorrhea?

Amenorrhea is the absence of a menstrual period.

Primary amenorrhea is when a young woman has not yet had a period by age 16.
Secondary amenorrhea describes someone who used to have a regular period but then it stopped for at least three months (this can include pregnancy).

What are the signs of amenorrhea?

The main sign of amenorrhea is missing a menstrual period.Regular periods are a sign of overall good health. Missing a period may mean that you are pregnant or that something is going wrong (see What are the causes of amenorrhea?).

It’s important to tell your health care provider if you miss a period so he or she can begin to find out what is happening in your body. Amenorrhea itself is not a disease, but is usually a symptom of another condition. Depending on that condition, a woman might experience other symptoms, such as headache, vision changes, hair loss, or excess facial hair.

What are the causes of amenorrhea?

Amenorrhea is a symptom of a variety of conditions, ranging from not serious to serious.

Primary Amenorrhea
- Chromosomal or genetic abnormalities can cause the eggs and follicles involved in menstruation to deplete too early in life.
- Hypothalamic or pituitary diseases and physical problems, such as problems with reproductive organs, can prevent periods from starting.
- Moderate or excessive exercise, eating disorders (such as anorexia nervosa), extreme physical or psychological stress, or a combination of these can disrupt the normal menstrual cycle.
Secondary amenorrhea
- This problem is much more common than primary amenorrhea.
- Common causes include many of those listed for primary amenorrhea, as well as pregnancy, certain contraceptives, breastfeeding, mental stress, and certain medications.
- Hormonal problems involving the hypothalamus, pituitary, thyroid, ovary, or adrenal glands can also cause amenorrhea.
- Women who have very low body weight sometimes stop getting their periods as well.
- Women with premature ovarian failure stop getting regular their periods before natural menopause.

What is treatment for amenorrhea?

Treatment for amenorrhea depends on the underlying cause. Sometimes lifestyle changes can help if weight, stress, or physical activity is causing the amenorrhea. Other times medications and oral contraceptives can help the problem. For more information, talk to your health care provider.

Where can I get more information about amenorrhea?

Do I Have Premature Ovarian Failure?

One of the most common signs of POF is having irregular periods. Women should pay close attention to their menstrual cycles, so that they can alert their health care provider when changes occur in their periods. If you are under age 40 and your periods are irregular, or if you miss your period altogether for three months or more, your health care provider may measure the level of FSH in your blood, to determine if you have primary ovarian insufficiency in its early stages, or possibly even fully developed POF. Remember that FSH signals the ovaries to make estrogen. If the ovaries are not working properly, as is the case in POF, the level of FSH in the blood increases. A higher level of FSH in the blood is a strong sign of POF. But, irregular periods alone are not a sure sign that you have POF—research shows that fewer than 10 percent of women who have irregular or skipped periods have high FSH levels and POF.

To do an FSH test, your health care provider will collect some of your blood and send it to a laboratory. At the lab, a technician will check the level of FSH. If the level of FSH is in the menopausal range, it is likely that you have POF.

Tengo Follica Ovarica Prematura?

Source:NIH

Posted in What You Need To Know | Tagged Amenorrhea, anorexia nervosa, breastfeeding, certain contraceptives, certain medications, Chromosomal abnormalities, excess facial hair, FSH, genetic abnormalities, hair loss, headache, Hypothalamic, menstrual period, mental stress, POF, premature ovarian failure, Primary amenorrhea, Secondary amenorrhea, Tengo Follica Ovarica Prematura, vision changes | Comments Off

Bacterial Vaginosis

Posted on September 4, 2011 by admin

Bacterial Vaginosis

According to the Centers for Disease Control and Prevention (CDC), bacterial vaginosis (BV) is the most common cause of vaginitis symptoms among women of childbearing age. It previously was called nonspecific vaginitis, or Gardnerella-associated vaginitis. Health experts are not sure what role sexual activity plays in developing BV.

Cause

BV is a sign of a change in the growth of vaginal bacteria. The resulting chemical imbalance occurs when different types of bacteria outnumber the normal “good,” or beneficial, ones. Instead of Lactobacillus (a type bacteria that normally lives in the vagina) being most common, increased numbers of bacteria such as Gardnerella vaginalis, Bacteroides, Mobiluncus, and Mycoplasma hominis inhabit the vaginas of women with BV.

Transmission

Although health experts are not sure what role sexual activity plays in developing bacterial vaginosis (BV), a change in sexual partners or having multiple sexual partners may increase a woman’s chances of getting the infection. Using an IUD (intrauterine device) and douching also may increase her risk of getting BV.

Diagnosis

A healthcare provider can examine a sample of vaginal fluid under a microscope, either stained or in special lighting, to look for bacteria associated with bacterial vaginosis (BV). Then, they can diagnose BV based on

Absence of lactobacilli bacteria

Presence of numerous “clue cells” (cells from the vaginal lining that are coated with BV germs)

Fishy odor

Change from normal vaginal fluid

Treatment

Healthcare providers use antibiotics such as metronidazole or clindamycin to treat women with bacterial vaginosis (BV). Generally, male sex partners will not be treated.

For updated information about the treatment for BV and other sexually transmitted infections, read the CDC STD Treatment Guidelines.

Complications

In most cases, bacterial vaginosis (BV) causes no complications. There have been documented risks of BV, however, such as an association between BV and pelvic inflammatory disease (PID). PID is a serious disease in women that can cause infertility and tubal (ectopic) pregnancy.

BV also can cause other problems such as premature delivery and low-birth-weight babies. Therefore, some health experts recommend that all pregnant women who previously have delivered a premature baby be checked for BV, whether or not they have symptoms. A pregnant woman who has not delivered a premature baby should be treated if she has symptoms and laboratory evidence of BV.

BV also is associated with increased chances of getting one or more sexually transmitted diseases, including chlamydia, gonorrhea, or HIV infection.

Source: U.S. Dept. Health and Human Services

Posted in What You Need To Know | Tagged antibiotics, Bacterial Vaginosis, Bacteroides, Capital Care Network, capitalcarenetwork.com, CDC, CDC STD Treatment Guidelines, Centers for Disease Control and Prevention, chlamydia, clindamycin, ectopic pregnancy, Fishy odor, Gardnerella-associated vaginitis, gonorrhea, HIV infection, infertility, IUD, lactobacilli bacteria, Lactobacillus, metronidazole, Mobiluncus, Mycoplasma hominis, pelvic inflammatory disease, PID, sexual activity, tubal | Comments Off

NIH Study Reveals Half Of All Bladder Cancer In Women Due To Smoking

Posted on August 31, 2011 by admin

Study Confirms Cancer Risk from Smoking Is Higher Than Previously Estimated.

August 29, 2011

Current cigarette smokers have a higher risk of bladder cancer than previously reported, and the risk in women is now comparable to that in men, according to a study by scientists from the National Cancer Institute (NCI), part of the National Institutes of Health. The report was published on Aug. 16, 2011, in the Journal of the American Medical Association.

This latest study uses data from over 450,000 participants in the NIH-AARP Diet and Health Study, a questionnaire-based study that was initiated in 1995, with follow-up through the end of 2006.

While previous studies showed that only 20 to 30 percent of bladder cancer cases in women were caused by smoking, these new data indicate that smoking is responsible for about half of female bladder cancer cases – similar to the proportion found in men in current and previous studies. The increase in the proportion of smoking-attributable bladder cancer cases among women may be a result of the increased prevalence of smoking by women, so that men and women are about equally likely to smoke, as observed in the current study and in the U.S. population overall, according to surveillance by the CDC. The majority of the earlier studies were conducted at time periods or in geographic regions where smoking was much less common among women.

The researchers found that the amount of risk brought on by smoking, called excess risk, was higher in this study than in previously reported. “Current smokers in our study had a fourfold excess risk of developing bladder cancer, compared to a threefold excess risk in previous studies. The stronger association between smoking and bladder cancer is possibly due to changes in cigarette composition or smoking habits over the years,” said study author Neal Freedman, Ph.D., in NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “Incidence rates of bladder cancer in the United States have been relatively stable over the past 30 years, despite the fact that smoking rates have decreased overall. The higher risk, as compared to studies reported in the mid-to-late 1990s, may explain why bladder cancer rates haven’t declined.”

Although there have been reductions in the concentrations of tar and nicotine in cigarette smoke, there have been apparent increases in the concentrations of certain carcinogens associated with bladder cancer. A 2009 NCI/DCEG study was the first to suggest a higher risk for smoking-induced bladder cancer than previously reported. That report, based on data from the New England Bladder Cancer Study, found that the association between cigarette smoking and risk of bladder cancer appeared to be stronger than it was in the mid-1990s. The results of the new study confirm the 2009 report.

In the current study, former smokers were twice as likely to develop bladder cancer as never smokers, and current smokers were four times more likely than those who never smoked. As with many other smoking-related cancers, smoking cessation was associated with reduced bladder cancer risk. Participants who had been smoke-free for at least 10 years had a lower incidence of bladder cancer compared to those who quit for shorter periods of time or who still smoked.

“Our findings provide additional evidence of the importance of preventing smoking initiation and promoting cessation for both men and women,” said senior author Christian Abnet, Ph.D., also from DCEG. “Although the prevalence of cigarette smoking has declined, about 20 percent of the U.S. adult population continues to smoke.”

Even though smoking carries the same risk for men and women, men are still about four times more likely to be diagnosed with bladder cancer. These results, as well as those from previous studies, suggest that difference in smoking rates explain only part of the higher incidence rates in American men. The researchers suggest that occupational exposures, as well as physiologic differences, may contribute to the gender disparity.

In 2011, approximately 69,250 people will be diagnosed with bladder cancer in the United States, and 14,990 will die from the disease.

Source: National Institute of Health

Posted in What You Need To Know | Tagged aarp, bladder, Capital Care Network, cigarette, epidemiology, health, NIH, prevalence, rate, Smoking | Comments Off

Women's Health First

Creating An AIDS-Free Generation Remarks

The VOICE HIV Prevention Study

Cardiovascular Disease In Women

HEART DISEASE

General Information About Breast Cancer

What is screening?

Genetically Informed Approaches to Lung Cancer’s Complexity

Lung Cancer is Not a Single Disease

Crizotinib: A Promising New Targeted Drug

HPV Vaccine – Questions & Answers

Menstruation and the Menstrual Cycle

What is menstruation?

What are the signs of menstruation?

What if I have a problem with my menstrual periods?

Are there treatments for painful menstruation?

The Normal Menstrual Cycle

Amenorrhea

Amenorrhea

What are the signs of amenorrhea?

What are the causes of amenorrhea?

What is treatment for amenorrhea?

Where can I get more information about amenorrhea?

Bacterial Vaginosis

Bacterial Vaginosis

Cause

Transmission

Diagnosis

Treatment

Complications

NIH Study Reveals Half Of All Bladder Cancer In Women Due To Smoking

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