Protect Yourself: New Possibilities for Women in the Bedroom

Did you know that there are products being developed RIGHT NOW which some say could be the biggest breakthrough in the prevention of sexually transmitted infections (STIs) since the condom?

In any intimate relationship, it is easy to see how a request to use condoms could come off as lack of trust. How many women do you know who would feel comfortable asking even their husbands to use a condom?

Women could soon be able to use creams, gels, and suppositories, or "films" called "microbicides" that kill and/or work as a barrier against disease-causing organisms when inserted before intercourse.

We wouldn’t need to rely on condoms and our partner’s willingness to use them every time, because by using a microbicide we can protect ourselves and our partners quietly and discreetly.

Are you or someone you care about having sex? Do you pay taxes or are you concerned about the rapidly escalating cost of health care in this country?

If you answered ‘yes,’ then get on our website, www.womenmatter.com, and tell your Representative that legislation to fund microbicide research is pending in Congress RIGHT NOW-- and their support is critical.

Let’s talk about sex...

Do you feel comfortable talking to your partner about sexually transmitted diseases? Not all of us do.

That’s why it’s so important for us women to have the ability to protect ourselves and our partners right now.

While our society has become more open about sex in general, it’s no wonder that for many women, the topic of STIs is still uncomfortable and unfamiliar.

Creams, gels, oils, and lubricants designed to be applied by women before sex have become a booming business, advertised widely and available at every local drugstore. But even as the use of personal lubricant products has become increasingly widespread and socially acceptable, microbicides products which could be used similarly to prevent STIs are still being tested.

If any of the microbicides that are currently in late-stage clinical trials proves effective, we could have a product on the market a few years down the road. That’s why it’s so important to spread the word about microbicides and tell our representatives in Congress to fund microbicide research right now.

One way that widespread distribution of microbicides could drastically reduce the spread of HIV, Clamydia, and other sexually transmitted infections and diseases is by eliminating the effect of a major barrier to disease prevention: communication between partners.

In addition, many men-- and women-- complain of experiencing less pleasure and sensation while using a condom. Even assuming that your partner is on board and the condom does not break, are you absolutely sure that you can trust yourself every single time?

No matter how good our intentions, most of us are more likely to let our guard down in an intensely intimate situation. Microbicides are being tested in a variety of slow-release forms that could prevent disease for up to three weeks after they are used.

Why do women need microbicides?

Women start out at least twice as susceptible to HIV and STIs because of the shape of our bodies. But let’s be graphic. It’s also all about friction.

Both initial penetration and the motion of the penis thrusting in and out during intercourse can cause microscopic tears in the woman’s vaginal lining that may admit viruses and bacteria -- particularly if she is "not in the mood," and/ or the vagina is not naturally lubricated for any other reason. In addition, the vagina has more surface area, and three levels of tissue which can be torn during intercourse, making it more vulnerable to infectious organisms, even if the tears are too tiny to see or feel.

Many factors, including who has the money, who has the legal power, and whether the relationship is violent prevent women from negotiating both fidelity, and condom use. To learn more about the underlying theme of power and control in the continuing problem of relationships that start with love and grow into abuse click here.

Women and HIV

In addition to being more likely to get HIV, if we do become infected, HIV disproportionably affects women and children. In women, HIV can influence the progression of other STIs, such as HPV infection ("genital warts"), with HIV positive women progressing to cervical cancer at a more rapid rate than HIV negative women. In addition, HIV positive women seem to be more likely to get recurrent vaginal yeast infections and other STIs, according to an NIH researcher.

Often, women with HIV infection have great difficulty accessing health care, - as women often do in general--and carry the burden of caring for children and other family members who may be HIV-infected as well. They are often stigmatized by their communities and face other challenges like finding adequate child care, affordable transportation, and money they can manage on their own. These factors may interfere with their ability to stick with treatment -- if they can get it at all.

Rising rates of HIV infection among women will continue to have profound effects -- and not just for individual women who become infected. The Global Health Council, www.globalhealth.org, chose the slogan, "Healthy Women, Healthy World" to emphasize the fact that as custodians of family health, women play a unique role in maintaining the health and well-being of their communities.

Considering cost: looking at the long-term picture

The Centers for Disease Control and Prevention (CDC) reports that from 2001 through 2005, the estimated number of persons in the United States living with AIDS increased from 331,512 to 425,910 - an increase of 28%.

And women with AIDS make up an increasing part of the epidemic. In 1992, women accounted for an estimated 14% of adults and adolescents living with AIDS. By the end of 2004, this proportion had grown to 23%.

These figures represent not only a public health crisis, but also a potentially devastating cost to an already overburdened healthcare system. The issue is particularly significant to all women because so many of us have the primary responsibility for health and healthcare in our families and communities.

Trust, but verify

Many, many women right here in America, both rich and poor, and of all ages and races, do not have the luxury of trusting our intimate partners.

Worldwide, more than 90 percent of HIV infections have resulted from heterosexual sex. And according to Representative Christopher Shays, R-CT, "In many settings, the typical woman who gets infected with HIV has had only one partner, her husband."

Securing funding for microbicide research and development is critical because even in strong relationships, trust alone is not guaranteed to prevent infection.

Someone with HIV or AIDS can take years to show any symptoms. And carriers of STIs like Clamydia, gonorrhea, and HPV, "genital warts"-- which can cause infertility or worse down the line -- may never show any symptoms at all.

Even a negative STI test is not always positive evidence - the presence of HIV can take months to show up on a test.

Many women are unintentionally infected by partners who have no reason to believe that they have an STI themselves. As much as 27% of people with HIV or AIDS in the US were undiagnosed and unaware of their HIV infection at the end of 2003, according to the Center for Disease Control. Even when trust and awareness are present, information may not be accessible.

Representative Shays has introduced legislation that would increase financing for microbicide research which is being debated in Congress right now.

Keep reading or click here to see a summary of the bill and who has signed it. WomenMatter will continue to track this issue. Visit www.womenmatter.com for nonpartisan analysis of the latest legislation, and contact your representative straight from the site at a time which is convenient for you.

Putting the risk in perspective

Haven’t we all felt at one time or another that AIDS is ‘someone else’s disease’? That ‘someone like me’ is not at risk for contracting an STI?

Of course! No one wants to consider the possibility of contracting a socially stigmatized and potentially lethal infection, particularly from an intimate partner.

But consider this: are you on friendly terms with the previous partners of your current partner? For most women, a cordial relationship is the exception, not the rule. Now would you be willing to put your sexual health in his or her hands?

How about every single person that your partner has ever been intimate with (and yes, this includes ‘that one time in college’)?

What about all their partners, too?

And for that matter, what about all of your partners? And their partners, etc, etc, etc?

All of us women owe it to both ourselves and to our partners to step back and consider questions like these when it comes to STIs and what we can do to prevent them - both individually and together.

WomenMatter will continue to be a safe place where we can discuss the issues with women of all ages and stages, and throughout the country -- and a vehicle to make our voices heard by policymakers, before they make critical decisions that will impact each of our lives.

New possibilities: protection, prevention, & pregnancy

Microbicide products are currently being developed both with and without a spermicidal ingredient, providing women and our partners with new possibilities in the bedroom. Because only some microbicides will be formulated to prevent pregnancy, they would eliminate the need for anyone to make a choice between safe sex and conceiving a child.

Microbicides work in a variety of ways. They can: kill or immobilize STI microbes, form a barrier between the viruses and vaginal or rectal tissue, block the early steps of infection, prevent the microbe from replicating once it has entered cells, and/or work to boost the vagina’s own defense system.

The London School of Hygiene and Tropical Medicine in London has estimated that even a partially-effective microbicide could prevent more than 2 million HIV infections over a three-year period.

Microbicides may also prevent Clamydia, a sexually transmitted disease that is caused by bacteria and can damage a woman’s reproductive organs and prevent her from having children. Clamydia is the most common STD in the United States, with almost a million infections reported in 2004. Microbicides could help to reduce that number.

Yet they are still in the research and development phase, there is a shortage of clinical trials, and additional funding is urgently needed.

To learn more about what you can do RIGHT NOW to support legislation that would increase financing for microbicide research, keep reading or, click here.

The long path from the laboratory to the local drug store

Scientists have been looking at how microbicides could be used to prevent the spread of HIV since the late 1980s. So why aren't microbicides readily available RIGHT NOW?

Part of the reason is that any kind of new medicine has to undergo a lengthy and expensive screening and testing process between the laboratory and the local drug store. On average, it costs roughly $57 million to take a single microbicide lead through the entire process of testing required to license it for sale.

• Clinical Research:

As of 2006, there are an estimated three dozen microbicides products in preclinical research and development. These candidate products must pass an initial screening to be approved for clinical testing on humans.

Even after extensive laboratory and animal testing, most of these concepts never make it to the clinical trial stage.

Under guidelines established by the Food and Drug Administration (FDA), candidate drugs like microbicides are tested in three stages of clinical trials to prove safety and efficacy. Generally Phase I tests safety, Phase II tests safety in greater numbers of people and may tell us something about effectiveness, or efficacy, and Phase III looks at the safety and effectiveness of the product in many more trial participants.

As of August 2006, 16 microbicides are being tested in people, and four are in late-stage trials. To learn more about the microbicide products in clinical development, click here

The later-stage trials are particularly challenging and time-consuming because of the large number of human subjects needed to confirm that a new product will actually do what it claims to do and is safe to use.

At every stage, some products are eliminated. But learning what doesn’t work helps researchers design more effective and efficient trials in the future.

The whole process of clinical research depends on constantly screening out candidate treatments that have been proven not to work so research and funding can focus on learning more about the products which have shown promise.

Securing consistent funding for microbicide research is critical because successful clinical research depends on both developing and testing new concepts, and making sure that when a candidate does show promise, there is enough funding to pay for the trial and study to prove it.

To find your representative and tell them to make reliable long-term funding for microbicide research a priority right now, click here. Keep reading to learn more about the research and development process for microbicides, and the specific challenges facing researchers.

• Product Development:

While clinical research is essential, it is only part of the process of turning a promising new medicine such as microbicides into a product we can buy and use.

Scientific discoveries about new medicines attract publicity and funding because of their exciting potential to cure or prevent disease. But transforming a promising concept into a marketable product involves both cost and risk.

Before a candidate microbicide can be considered for clinical evaluation, product developers must demonstrate through extensive research that the active ingredients, or agents, have been put into a stable formulation (such as a gel, cream, or foam). The candidate product is then manufactured in increasingly larger quantities for clinical trials. These steps are expensive and must be taken long before it is known whether a product is effective and marketable. To read more about microbicide development click here.

To tell a friend, family member, or colleague about microbicides, click here, to send them a link to this essay on www.womenmatter.com.

To find your representative and make sure they know the Facts & Trade-Offs about microbicides, click here to let them know about the WomenMatter microbicide initiative.

Funding the future

The microbicide field is on the verge of a historical breakthrough: providing women with the ability to protect ourselves and our partners from STIs.

Incredible advances have already been made in terms of research, awareness, and funding. Maintaining this momentum is absolutely crucial -- and the time to act is RIGHT NOW.

Expanding research into areas like the basic facts about STI transmission, and persuading trial subjects to accurately report intimate information that is normally considered very private, will also be necessary.

As of October, 2006, several major analyses have concluded that an annual investment of $280 million is now needed to capitalize on current microbicide research and to satisfy the commitments already made to ongoing research and development.

• Pharmaceutical Companies & Microbicides

The potential market for an effective microbicide against HIV is estimated at $1.8 billion by 2020, according to studies done a few years ago that were supported by the Rockefeller Foundation.

However, because financial profits will be small, at least at the outset, and conducting microbicide trials is risky and expensive, many private pharmaceutical companies have been hesitant to invest significant resources.

By donating their intellectual property rights, some pharmaceutical companies have contributed to microbicide development without undergoing the expensive & complicated research process. Merck & Co., Inc., Bristol-Myers Squibb, and Gilead have granted royalty-free licenses to develop, manufacture, and distribute their compounds for use as microbicides in resource-poor countries to the non-profit International Partnership for Microbicides (IPM).

Donations like these are a good start- but extensive funding will be needed to take full advantage of their potential.

In many other cases, inadequate funding paired with high levels of cost and risk discourage investment by pharmaceutical companies all together and make it difficult for small biotech companies or university teams to conduct clinical trials.

Product development involves additional costs which can significantly slow down microbicide research if they are not recognized and taken into account by funders, including our government. Increased awareness about the costs of microbicide development will be necessary to secure adequate funding.

In order to develop a more efficient process for screening out less likely candidates and investing in the more likely ones, it will also be necessary to conduct research to evaluate how effective funding has been in the past.

Click here to read more about the ethical issues pharmaceutical companies face conducting microbicide research

• Government Funding for Microbicides

President Bush has promised $15 billion over five years to fight AIDS, the largest single pledge ever made to fight a disease-- but there is no guarantee that microbicide research and development will benefit as a result, at least not in the near future. Because there is no proven cure or wide-scale treatment for AIDS, funding is split among various programs ranging from abstinence education to providing antiretroviral treatment to people who are already infected.

Current approaches to HIV/ AIDS include three basic categories: prevention before exposure (vaccines, abstinence); prevention at the time of exposure (male and female condoms, anti-retroviral drugs to prevent mother-to-child infection); and treatment and care (anti-retroviral therapies, basic care).

Microbicides are being developed now which fall into both of the first two categories: preventing infection both before exposure and at the time of exposure.

Up to this point, barely 3% of the US budget for HIV/AIDS research -- three cents of every dollar -- is spent on efforts to find a safe, effective microbicide. The lion’s share of funding for AIDS prevention has gone to developing a vaccine, despite indications that an effective microbicide could be made available much more quickly-- and have a significant effect.

A $500 million grant from the Gates Foundation to the Global Fund for Microbicides has helped to raise awareness worldwide, and increased funding will be critical to taking advantage of the momentum which has been generated. The Global Fund at present has NO money for research; only for getting more people who are already infected on antiretroviral treatment.

Government funding for microbicides has grown from $34.6 million for the Fiscal Year 2000 to an estimated $99.3 million for Fiscal Year 2005. But consistent, long-term funding is urgently needed RIGHT NOW, particularly funding marked specifically for microbicide research, which has lagged significantly behind investment in other prevention and treatment options.

President Bush has requested $5.4 billion for the President's Emergency Plan for AIDS Relief (Emergency Plan/PEPFAR) in fiscal year 2008. To learn more about the budget process and how you can influence how your tax dollars are spent, click here.

Up to this point, there has been no PEPFAR funding that has actually gone into microbicides research or coordination. However, in 2006, Congresswoman Nita Lowey of New York’s 18th District asked Acting U.S. Global AIDS Coordinator Mark Dybul about the possibility of PEPFAR funding microbicide activities and his answer was that PEPFAR would be happy to use any safe and effective microbicides that are developed.

To tell your representative to make funding for microbicide research a priority, click here --and be specific about how you want funding for AIDS research spent. Our representatives DO care what we think, and they need our input on this critical issue.

Current Legislation-- How & Where to Weigh in & Make a Difference NOW

The following legislation is currently pending in Congress -- and we can still do something about RIGHT NOW by weighing in with our representatives straight from the WomenMatter website, www.womenmatter.com.

• Microbicide Development Act of 2007 (H.R.1420, S.823)

The goal of the Microbicide Development Act of 2007 (MDA) is to achieve better coordination and expanded resources for microbicide research and development. The Microbicide Development Act would establish a dedicated microbicide research and development branch at the National Institutes of Health and strengthen microbicide activity at the United States Agency for International Development and the Centers for Disease Control and Prevention. The MDA has been introduced in both the Senate and the House and has been referred to the appropriate committees.

The Microbicide Development Act was reintroduced in the Senate and the House on International Women's Day, March 8, 2007 by Senators Barack Obama (D-IL) and Olympia Snowe (R-ME), and Representatives Janice D Schakowsky (D-IL) and Christopher Shays (R-CT).

The legislation builds on the Microbicide Development Act of 2005, introduced in the Senate exactly two years earlier by Senator Obama (D-IL), Senator Snowe (R-ME), and Jon Corzine (D-NJ - now Governor of New Jersey). Representative Christopher Shays (R-CT) and Representative Janice D. Schakowsky (D-IL) introduced the House version on Sept 21, 2005.

To see a list of the Senators and Representatives who have signed the bill click here.

Is your Senator or Representative on the list?

If not, let them know about the WM initiative and tell them to sign the bill RIGHT NOW.

• Vaccines for the Future Act of 2007 (S.569)

On February 13, 2007, Senator Richard Lugar (R-IN) introduced the Vaccines for the Future Act of 2007 (S.569) in the US Senate. Although microbicides are not mentioned in the Act’s title, they are an integral part of the legislation. Building upon legislation previously introduced by Senators Kerry and Frist (R-TN) in 2001, S.569 Directs the President to "establish a comprehensive strategy to accelerate efforts to develop vaccines and microbicides for neglected diseases such as HIV/AIDS," and would provide incentives for companies to accelerate development of vaccines and microbicides. Microbicides are discussed throughout the legislation.

The house version of the bill, (H.R.1391), was introduced by Rep. Peter J. Vislosky (IN-1) on March 7, 2007.

To see a list of Representative who have signed the bill click here.

Is your Senator or Representative on the list?

If not, let them know about the WM initiative and tell them to sign the bill RIGHT NOW.

Making government work for us

Funding is a critical first step but the complicated issues surrounding microbicide development will need to be revaluated continuously. Our input and participation in the process will be critical to making government work for us.

But who is ‘government’ in the case of microbicides? When we let our representatives in Congress know that an issue is important to their constituents, us, they look for funding for the issue wherever they can -- obtaining funds under whatever rubric is popular at the moment.

Thus, in typical government fashion, microbicide programs are spread across various and loosely-connected government agencies.

There are three major Federal agencies with significant microbicide research and development programs: the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the US Agency for International Development (USAID). But no one branch, unit, office, or person is in charge of coordinating all of the research.

The National Institutes of Health (NIH) is the largest single agency involved in microbicide research and development. The NIH is the leader in promoting the issue and fostering scientific inquiry, but has so far largely lacked a coordinated approach to research and funding because authority for microbicide research is not centralized.

The NIH is working to establish a separate microbicide branch and recently funded a Microbicide Trials Network -- an important step towards more efficiency and transparency in the field, but there is agreement on needing to keep up the pressure for this to actually occur - and promptly.

The microbicide research and development program at USAID has grown from $2.3 million in Fiscal Year 1999 to an estimated $30 million for Fiscal Year 2005, With approximately three quarters of its microbicide budget dedicated to clinical testing, USAID supports costly -- yet necessary -- parts of the process such as Phase III clinical trials, and aspects of manufacturing and packaging.

Continued funding to support the most costly and least visible steps of research and development is necessary, and will only be possible if more funding is dedicated exclusively to clinical research.

The Center for Disease Control program is currently the smallest of the three, but Congress has increased funding and explicitly stated its support for microbicide research at the CDC in annual appropriations bills and reports.

One explanation for the lack of a single cohesive microbicide program is that our political system encourages our representatives in Congress to focus on local issues which impact voters more directly and immediately.

But as researchers learn more about microbicides, coordination and cooperation have become increasingly important.

The spread of AIDS is a problem which will increasingly affect each and every one of us -- if it hasn’t already. As HIV spreads, our government will face both ethical and practical pressure to provide health care.

The lowest possible price for first-line treatment drugs for AIDS is about $130 per person per year. The cost of personnel, lab work, and other expenses easily exceeds another $200 per person per year. And that’s not even counting the cost of much more expensive second-line therapies, which many patients will need.

And you thought health insurance was expensive now?

The spread of AIDS and other STIs is a public health issue that we can neither afford to ignore, nor effectively address individually.  

The ethical challenges of microbicide trials - A double-edged sword

On top of the cost and complexity involved with testing any new medicine, microbicide researchers face a host of more specific challenges. Designing and carrying out microbicide trials that are both effective and ethical, is particularly tricky.

Unfortunately, some of the qualities that make microbicides so promising, - that they are designed to prevent STIs, can be used by women to protect ourselves and our partners quietly and discreetly and could prevent the spread of AIDS among those most vulnerable to infection - turn out to be the same qualities which make trial-design so challenging.

Fairness is and has to be a global standard. But infection rates vary dramatically across communities, and researchers have to take the practical implications of this fact into account.

The fact that communities that fit the criterion for these trials - communities where there are many new HIV infections each year -- are mainly in resource-limited countries or among other vulnerable populations, highlights the connections among poverty, gender, and inequality.

Recruiting women who are highly vulnerable (in multiple ways) for microbicide trials in the course of which some of them may become infected makes obtaining - and defining - informed consent very difficult. However, this should be weighed against the fact that women at high risk for infection are likely to benefit greatly from the availability of microbicide products.

Typically, a drug or medicine is tested on individuals with a preexisting condition to determine whether it works to cure the condition or alleviate its symptoms. A prevention trial is different. For example, microbicide trials determine whether a microbicide can prevent new HIV infections in a group of healthy volunteers who are at high risk for infection.

So whom should we test to determine whether a microbicide prevents HIV infection? The simple answer is people who are "healthy" (that is HIV-negative), sexually active, and likely to be sexually active with partners who are already infected. In practice, this means testing in communities where a relatively high proportion of the population is already infected with HIV, and where there are many new infections every year, so that each healthy trial participant is likely to be exposed to HIV during the course of the trial.

For example, let’s imagine that in population A there are 500 new HIV infections among adult women for every 1000 adult women every year. If we recruit 1000 healthy women from population A in a microbicide clinical trial, we would expect 500 new HIV infections within a year--if the microbicide did not work to prevent HIV infection. However, if 1000 women were recruited, and 400 women became infected within a year, we could deduce that the microbicide prevented 100 infections or reduced the number of new infections, or incidence, by 20%.

Conversely, imagine that in population B, there are 5 new infections among adult women for every 1000 adult women every year. Therefore, if we recruit 1000 healthy women from population B into a microbicide trial, we would expect 5 new infections with a year. Let’s suppose we used the same microbicide we used in our clinical trial with population A for our clinical trial with population B, and there were 4 new infections among the trial participants. What does this tell us? Is the reduction from 5 to 4 new infections because of the microbicide or some other factor? The number of new infections has been reduced from 5 to 4 per 1000 women, which is a 20% decrease in incidence, but the data would be highly unreliable. Therefore, we would have to recruit thousands of women from population B to obtain meaningful and reliable data.

Therefore, it would be preferable to carry out a microbicide trial where the number of new infections every year is high. If the microbicide is tested in a community where a low proportion of the population is HIV infected and where there are few new HIV infections each year, it would require an enormous amount of clinical trial participants to determine whether the microbicide is working to reduce the number of new HIV infections. However, fewer trial participants are needed if the clinical trial is carried out in a population that is at higher risk for HIV infection.

Working through the important ethical questions surrounding microbicide research presents major challenges to researchers, sometimes contributing to the shortage of clinical trials. However, basic standards for fairness demand that issues like language and/or cultural barriers between researchers and participants, and obtaining informed consent be overcome BEFORE a trail begins.

As the microbicide field grows up, it will be absolutely critical to continue to secure enough funding for the research and education that takes place even before a trail begins. Weigh in with your legislators about the importance of additional funding to make sure that microbicide trails are conducted ethically right now.

What do you think?

Another question to consider is if, and how, the western model of the ‘double-blind’ study can be applied usefully and ethically to clinical trials for microbicides, particularly those made up of developing-world research subjects.

One of the most innovative features of microbicides is that unlike condoms, they offer women the option to protect ourselves and our partner discreetly, and put the decision (and the responsibility) to use protection in our hands. The lack of an equivalent product contributes to the urgent need of developing an effective microbicide:

"Microbicides are not just another new drug or prevention tool in a field of many. Until an effective vaccine is developed, microbicides (even partially effective ones) will stand as the only means of prevention for millions of women who presently have nothing at all with which to protect themselves from HIV" -Statement of the Global Campaign for Microbicides, FDA Center for Drug Evaluation and Research (CDER), Antiviral Drug Advisory Committee Meeting, August 20, 2003, Bethesda, MD

However, the fact that microbicides are a new technology within a relatively new field is also a major barrier to conducting effective and ethical clinical trails.

In double-blind studies to test whether a new medicine works as well or better than a similar drug which is already on the market, one group of participants is given the medicine being tested and another group is given an identical product containing a 'proven placebo.’ These types of studies are generally considered to be the gold standard for objectivity because neither the researchers nor the subjects know who is getting what in the trial.

Conducting double-blind studies for a new type of product like microbicides, with no comparable, proven product to test against is trickier. In these kinds of trials, one group is given a placebo without any known medical effect.

On the one hand, it is clearly unethical to give women already at high risk for contacting AIDS a placebo that offers no protection, but may well offer the illusion of protection. All researchers face the problem that the very fact that the study is being conducted may influence the behavior of their subjects in unpredictable ways.

But on the other hand, measuring the effect of a candidate microbicide on top of already proven prevention tools like condoms and counseling can be extremely problematic, delaying -- or even preventing-- a good product from reaching those that need it.

This is especially true for microbicides with a lower expected efficacy than condoms, including most products being tested now.

But remember, microbicide research is a new field-- and as is the case in all new fields and technologies, research is a continuous process which builds on itself. There is not a drug on the market today that has not been improved upon. The development of safer and more effective methods of birth control and new treatments for HIV and AIDS patients are good examples.

Plus, even a partially-effective microbicide could prevent more than 2 million HIV infections over a three-year period.

What do you think?

How should the urgent need for even a partially effective microbicide be weighed against the ethical questions raised by of testing a drug that is still in development on human subjects?

A consensus is growing that communities in which microbicides are tested should be entitled to receive the product first, and that long-term care should be guaranteed for trial participants who become infected during the trial. But while satisfying some ethical concerns, these commitments also represent a serious long-term financial and logistical burden for researchers.

These issues represent the traditional conflict between the protection of individual research subjects and the possible benefit of a microbicide product to society.

Traditionally, clinical research on human subjects has been justified because of the potentially huge benefits to society if the medicine works. In addition, participants in clinical trails for microbicides receive the added benefit of monthly check-ups, prevention counseling, and treatment should they become infected during the trial.

What do you think?

Who should be responsible for providing treatment and care to individuals who become infected during trials or who screen out because they are already infected?

Your Input Matters

The ethical issues involved in microbicide trials are complex, unclear, and often highly political. Thinking through these issues is absolutely critical, and to make the best possible decisions, legislators need YOUR input.

Would you use microbicides if they were readily available?

Your representatives DO care what you think. Let your congressional representatives know what you think! Give your senators a piece of your mind! To find your reps, click here.

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The following is a list of Representatives that have signed the Microbicide Development Act of 2007 (H.R.1420)

Is your Representative on the list?

If not, click here to let them know about the WomenMatter microbicide initiative and tell them to sign the bill.

• Melissa Bean (IL-8) - 3/8/2007
• Howard Berman (CA-28) - 3/8/2007
• Corrine Brown (FL-3) - 3/20/2007
• Lois Capps (CA-23)- 3/8/2007
• Danny Davis (IL-7) 3/8/2007
• Susan A. Davis (CA-53) - 3/14/2007
• Diana DeGette (CO-1) - 3/14/2007
• Rahm Emanuel (IL-5) - 3/8/2007
• Anna G. Eshoo (CA-14)- 3/20/2007
• Raul Grijalva (AZ-7) - 3/8/2007
• Mazie K. Hirono (HI-2) - 3/20/2007
• Sheila Jackson-Lee (TX-18)- 3/14/2007
• Mark Steven Kirk (IL-10) - 3/8/2007
• Barbara Lee (CA-9) - 3/8/2007
• Doris O. Matsui (CA-5)- 3/8/2007
• Jim McDermott (WA-7)- 3/8/2007
• Michael R. McNulty (NY-21) - 3/8/2007
• Eleanor Holmes Norton (DC) - 3/14/2007
• Allyson Y. Schwartz (PA-13)- 3/8/2007
• Christopher Shays (CT-4) - 3/8/2007
• Rep Stark, Fortney Pete (CA-13) - 3/14/2007
 

The following is a list of Senators and Representatives that have signed the Microbicide Development Act of 2007 (S.823)

Is your representative on the list?

If not, click here to let them know about the WomenMatter microbicide initiative and tell them to sign the bill.

In the Senate:

• Jeff Bingaman (D-NM) - 3/12/2007
• Barbara Boxer (D-CA) - 3/8/2007
• Sherrod Brown (D-OH) 3/22/2007
• Hillary R. Clinton (D-NY) - 3/8/2007
• Christopher J. Dodd (D-CT) - 3/8/2007
• Richard J. Durbin (D-IL) - 3/8/2007
• John F. Kerry (D-MA) - 3/8/2007
• Patrick J. Leahy (D-VT) - 3/12/2007
• Barbara A. Mikulski (D-MD) - 3/27/2007
• Charles Schumer (D-NY) - 3/8/2007
• Gordon Smith (R-OR) - 3/20/2007
• Olympia J. Snowe (R-ME) - 3/8/2007

In the House:

• Earl Blumenauer [OR-3] - 3/27/2007
• Corrine Brown [FL-3] - 3/29/2007
• Julia Carson [IN-7] - 3/7/2007
• Elijah E. Cummings [MD-7] - 3/13/2007
• Al Green [TX-9] - 3/9/2007
• Raul M. Grijalva - [AZ-7] - 3/28/2007
• Steve Israel [NY-2] - 3/26/2007
• Sheila Jackson-Lee [TX-18] - 3/26/2007
• Peter T. King [NY-3] - 3/7/2007
• Barbara Lee [CA-9] - 3/8/2007
• Zoe Lofgren [CA-16] - 3/28/2007
• James P. McGovern, [MA-3] - 3/7/2007
• Michael R. McNulty [NY-21] - 3/7/2007
• Eleanor Holmes Norton [DC] - 3/13/2007
• Charles B. Rangel [NY-15] - 3/7/2007
• Mark E. Souder [IN-3] - 3/9/2007
• Henry A. Waxman [CA-30] - 3/23/2007

Posted on: 4/3/2007