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Sleep Drugs: What Every Woman Should Know

Society for Women's Health Research — Mon, 25 Apr 2016 16:10:14 +0000

Image courtesy of SWHR via Flickr

Sex Differences and Sleep

There are distinct biological and physiological differences between women’s and men’s sleep. According to the Society for Women’s Health Research (SWHR®), sex chromosomes, as well as gonadal hormones play a role in how individuals of each sex sleep, the sleep disorders they experience, and their responses to sleep medications. Examples of sleep differences between the sexes include women being more likely to experience disorders such as insomnia and restless leg syndrome (RLS); depression, pain, and stress are more likely to cause sleep disturbances in women than in men; and women being susceptible to changes in sleep throughout their lives, particularly at points when they experience hormonal and physical changes like puberty, pregnancy, and menopause.

Sex Differences and Sleep Drugs

Similar to how sex differences can impact sleep and sleep disorders, the way that these disorders are treated can also be affected by sex differences.

Case Study: Zolpidem

In 2013, the Food and Drug Administration (FDA) took a huge step by recommending sex-specific regulations for the prescription of sleep drugs that include zolpidem. This was groundbreaking in that it was the first time that the FDA had ever specifically recommended a sex-specific dosage for a particular medication. Zolpidem, which is used to treat insomnia, is found in Ambien, Edluar, and Zolpimist–all commonly prescribed sleep drugs. Zolpidem, a sedative-hypnotic, slows down activity in the brain.

The FDA reduced the recommended Zolpidem dosage for women to half of what was being prescribed. According to the SWHR:

This change in dosage was based on the discovery that women were metabolizing the same dose of drug 50 percent slower than men, which resulted in higher amounts of Ambien in women’s bloodstream leading to more excessive sleepiness in women compared to men.

Currently, the FDA is reviewing other popular sleep medications to determine if similar sex-specific recommendations should be issued for those as well.

Sleep Drugs and Contraceptives

We’ve all seen commercials for prescription drugs that recommend “talking to your doctor” before taking the advertised product, especially if currently using other medications. There’s a reason for that: drugs can interact and make other drugs less effective, causing unexpected side effects, or increasing the action of a particular drug. For women, it’s especially important to be aware of the interactions between hormonal contraception and sleep drugs.

Case Study: Modafinil

Combined hormonal contraceptives include the birth control pill, patches, injections, and vaginal rings like the NuvaRing. In the U.S., roughly 22 percent of women between the ages of 15 and 44 use contraceptives that fall into this category. Modafinil, which is a drug prescribed for certain sleep disorders like narcolepsy, sleep apnea, and excessive sleepiness, can lower the effectiveness of combined hormonal contraceptives. According to SWHR:

A specific enzyme in the liver breaks down modafinil to its composing molecules, which are then eliminated in the urine. The same enzyme that is responsible for clearing the body of modafinil also breaks down contraceptives. Studies have shown that, when taken together with modafinil, the overall blood levels of contraceptives decrease by 18 percent, resulting in potentially significantly lower effectiveness of the contraceptives.

Modafinil could also lower the effectiveness of other types of contraceptives, like emergency contraceptives such as the morning-after pill.

These interactions are also particularly concerning for women who become pregnant while still taking modafinil. Because modafinil lowers the effectiveness of contraceptives, this interaction is extremely unsafe for pregnant women and could potentially cause harm to a fetus.

Can contraceptives affect sleep?

Some evidence suggests contraceptives can cause changes in sleep for women. According to a 2001 study published in the European Journal of Physiology, oral contraceptives can affect sleep cycles and raise the body temperature of young women–another factor that plays a role in how well an individual sleeps. A woman’s menstruation cycle can also affect her body temperature, and therefore, how well she sleeps.

Sleep Drugs and Older Women

Women aged 55 and older are more likely to report sleepiness than men, and on average report 20 minutes fewer sleep per night than men. Post-menopausal women also report more fragmented sleep–they have a harder time staying asleep for long periods of time without waking up. According to the UCLA Sleep Disorders Center, physical factors can also disturb a post-menopausal woman’s sleep, such as arthritis and other pain-related conditions, chronic lung disease, heartburn, and a need to urinate more frequently.

But women aren’t alone in experiencing differences in sleep as they age–men do as well. As a result, both older men and women use sleep aids, which are often over-the-counter products. According to SWHR:

A recent health and wellness survey shows that 35 percent of people 60 years or older take OTC sleep medications at least 20 days a month. And 70 percent of them take OTC pain and sleep combination products, increasing the amount of the active ingredient in their system. This growing practice of self-medicating with OTC sleep products in an off-label way is alarming.

While those concerns are certainly valid–the mixing of medications, including over the counter drugs, can often cause problems; it’s still undetermined if there are any sex-specific effects of sleep medications on older women. Moreover, limited information is available as few sex-specific studies have been completed on how sleep medications and medications often taken by older women interact–a worrisome problem as older women continue to use these medications.

What’s Next?

The FDA is continuing to recognize that sex-differences are important when it comes to not only the differences in how American women and men sleep, but also how sleep medications can affect each sex. Additionally, nonprofits have been pioneering work studying and raising public awareness of these issues. Take, for example, the SWHR Interdisciplinary Network on Sleep. Launched in 2014, the network identifies areas in sleep health in which more work needs to be done specifically regarding women. According to SWHR:

The Society for Women’s Health Research is proud to bring together this interdisciplinary group to look at the critical issue of sleep in women’s health. We need greater focus on sex differences in sleep research to improve the diagnosis, treatment, and prevention of sleep disorders for both women and men. There continues to be knowledge gaps in the medical community regarding women and sleep. This SWHR Network is helping to address those gaps and highlight the importance of healthy sleep for everyone.

Sleep is important to all of us–woman or man, young or old. But recognizing the way different hormonal and physiological factors affect how we sleep, creating guidelines for medications based on those factors, and raising public awareness of risks associated certain sleep drugs and other medications are all steps in the right direction and will help us all sleep a little easier.

Resources

CDC: Prescription Sleep Aid Use Among Adults: United States, 2005-2010

Journal of Women’s Health: Exploring Sex and Gender Differences in Sleep Health: A Society for Women’s Health Research Report

Huffington Post: Why We Need to Pay More Attention to Women’s Sleep

NIH/Medline Plus: Zolpidem

NIH/Medline Plus: Modafinil

FDA: Questions and Answers: Risk of Next-Morning Impairment After Use of Insomnia Drugs; FDA Requires Lower Recommended Doses for Certain Drugs Containing Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)

Huffington Post: Are Your Sleep Drugs Hurting Your Contraceptives?

Guttmacher Institute: Contraceptive Use in the United States

RareConnect: Oral Contraception / Birth Control and Modafinil

European Journal of Physiology: Oral Contraceptives Alter Sleep and Raise Body Temperature in Young Women

UCLA Sleep Disorders Center: Sleep and Women

Huffington Post: Beware Risky Sleep Drug Usage in Older Americans, All for a Good Night’s Sleep

Sleep Review: Society for Women’s Health Research to Study Sleep Differences

Society for Women’s Health Research: Interdisciplinary Network on Sleep

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

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The Personal Care Products Safety Act: Modernizing Outdated Regulations

Society for Women's Health Research — Tue, 05 Jan 2016 16:14:36 +0000

Image courtesy of [Brenna Daugherty via Flickr]

Personal Care Products Regulation in the U.S.

Personal care products were first brought under the umbrella of the FDA with the passage of the 1938 Food, Drug, and Cosmetic Act, which provided for federal authority over such products. However, which products are defined as personal care products and which are defined as drugs is a nuanced question. According to the FDA, there’s no clear distinction under the law, but there are generalities that the agency uses to designate the category various products fall into. According to the FDA:

Under the law, some of the products commonly referred to as “personal care products” are cosmetics. These include, for example, skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants. Some, however, are regulated as drugs. Among these are skin protectants (such as lip balms and diaper ointments), mouthwashes marketed with therapeutic claims, antiperspirants, and treatments for dandruff or acne.

Some personal care products can meet the definitions of both cosmetics and drugs when that product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug, as it is intended to cleanse the hair and treat dandruff.

Regulations on drugs are obviously stricter than those on personal care products–understandably so– but there are some concerns over the ways that those personal care products are regulated.

What’s lacking from the FDA regulation of personal care products?

Guidelines that govern the FDA’s policies on personal care products haven’t been updated since the 1938 law that gave the Agency the authority to regulate these products. Yet, the science behind these products has evolved rapidly over the same time period. We now know more information about chemicals that could potentially be harmful. Additionally, many products contain new man-made chemicals, and the Agency should have policies in place that reflect the current state of the science governing these products.

Currently, the FDA cannot issue recalls of personal care products that it deems to be harmful. It can only recommend voluntary recalls, which critics are concerned aren’t strong enough to adequately remove dangerous products off the shelves in a timely fashion.

The lack of testing guidelines for personal care products are another area of concern for health advocates. Currently, the FDA doesn’t have the authority to mandate testing of ingredients before they go on the market, with one exception: color additives and no health studies or pre-market testing are required. Instead, the cosmetic industry is largely self-regulated through an organization known as the Cosmetics Ingredient Review (CIR). However, many advocacy organizations also question the efficacy of that group, particularly when it comes to CIR’s banning of substances. In the 36 years since its inception, the regulatory group has only 11 chemicals for use in personal care products, a stark contrast to the hundreds banned by European Union regulators.

Advocacy groups are also concerned over the labeling laws currently in place for personal care products. Currently, full ingredient disclosure isn’t required, which many criticize as a major loophole with regards to transparency and patient safety. There’s also no requirement for contact information, so people who may suffer from adverse reactions to products can’t always figure out how to get in touch with the manufacturer to report the problem.

Overall, the process for FDA approval of personal care products is significantly less strict than the process the Agency uses to approve drugs and medications.

What is the Personal Care Products Safety Act?

The Personal Care Products Safety Act would help remedy many of the regulatory loopholes cited above. and would give the FDA the regulatory authority it needs to issue recalls, improve testing guidelines, and require more stringent labeling.

Further, this legislation would mandate that the FDA take a proactive approach to ensuring that chemicals used in personal care products are safe by requiring that the FDA test and review at least five chemicals each year. The bill also lays out the first group of chemicals that would be reviewed, all of which have been subject to recent controversy. According to Senator Feinstein’s release on the act, that first group consists of:

Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotions;

Lead acetate, which is used as a color additive in hair dyes;

Methylene glycol/formaldehyde, which is used in hair treatments;

Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion; and

Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers

Additionally, the Personal Care Products Safety Act would require manufacturers of personal care products to register with the FDA. It would remove the protected status of “coal tar,” a carcinogen found in some hair dyes that currently is permitted as long as there are proper warning labels. It would also direct the FDA to come up with a list of “Good Manufacturing Practices” to guide producers.

The new programs and regulations instated by the bill would be funded by collecting user fees from personal care product manufacturers–this is a similar process FDA uses for the review and approval of prescription drugs.

Why is the Personal Care Products Safety Act particularly important for women?

While Americans use an average of roughly 10 personal care products each day, that number isn’t split up by sex. Women in particular use an average of 12 products, exposing themselves to 168 unique chemical ingredients each day. This puts women at a higher risk when it comes to being harmed by untested or unsafe chemicals. SWHR recognizes the impact that the Personal Care Product Safety Act, if it passes, will have on women’s lives and health. SWHR stated in support:

Women use these products daily, and safer, better-regulated personal care items means healthier women and families. SWHR commends this step towards advancing women’s health and the health of all Americans who use these products.

Where is the Personal Care Products Safety Act in the Legislative Process?

As of right now, the legislation has only been introduced into the Senate–it has a long way to go before it becomes a law. But there is some good news: the bill has bipartisan support, which in today’s political climate is certainly rare. Senators Feinstein and Collins are the original sponsors, but they’ve since been joined by four additional co-sponsors: Senator Barbara Boxer (D-California), Senator Amy Klobuchar (D-Minnesota), Senator Mark Kirk (R-Illinois), and Senator Mazie Hirono (D-Hawaii).

In addition to the SWHR, many other advocacy groups support the Personal Care Products Safety Act, including the Endocrine Society, the Environmental Working Group, and HealthyWomen.

Who Doesn’t Support the Personal Care Products Safety Act?

There are some who don’t agree with the tenants laid out in the Personal Care Products Safety Act. For example, People for the Ethical Treatment of Animals (PETA) has brought forth concerns that a greater concentration on testing means that there will be more testing on animals.

Others that disagree with the push for new regulations include members of the personal care products industry, including the Independent Cosmetic Manufacturers and Distributors (ICMAD) which says that it “places too large a burden on small business, stifles innovation in the cosmetics and personal care industry, and does not provide appropriate and significant national uniformity.”

Conclusion

The Personal Care Products Safety Act has a very long way to go before it could be enacted. But it reflects common sense approaches to regulating the personal care industry that haven’t been updated in almost 75 years. In order to ensure the health of all, particularly those who use these products on a regular basis, we need to make sure that there’s accountability and transparency in what goes into our personal care products.

If you would like to support the legislation, click below.

Outdated cosmetic regulations cover a big, advanced industry that affects everyone, everyday.

Tell your Senator to support S.1014

Take Action!

Resources

Primary

Society for Women’s Health Research: SWHR Proudly Supports Personal Care Products Safety Act

U.S. Senate: Personal Care Products Safety Act

GovTrack: S. 1014: Personal Care Products Safety Act

FDA: The 1938 Food, Drug, and Cosmetic Act

FDA: Are All “Personal Care Products” Regulated as Cosmetics?

Dianne Feinstein: Senators Introduce Bill to Strengthen Personal Care Product Oversight

Additional

Harvard School of Public Health: Harmful, Untested Chemicals Rife in Personal Care Products

Environmental Working Group: Why This Matters–Cosmetics and Your Health

FDA Law Blog: Proposed Personal Care Products Safety Act Would Significantly Expand FDA Authority over Cosmetics

Washington Monthly: Beauty Tips for the FDA

Women’s Voices for the Earth: Will the New Personal Care Products Safety Act Make Cosmetic Ingredients Safe?

The Huffington Post: New Bill Would Require FDA To Regulate Ingredients In Cosmetics & Personal-Care Products

PETA: Proposed Law Likely to Mean Tests on Animals for Cosmetics Ingredients in U.S.!

Society for Women’s Health Research

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Sexism in Science: Bias Beyond the Lab

Society for Women's Health Research — Mon, 12 Oct 2015 15:03:25 +0000

Image courtesy of [Society for Women's Health Research]

History of Sexism in Science

Sexism has been endemic in many aspects of scientific research; a full historical review would be as lengthy as it would be disheartening. But it’s important to recognize a consistent tradition of sex-based inequality in medical research. It has long been assumed that conclusions can be applied generally to both men and women, without taking into account the need to design studies that focus specifically on the biological and physical differences between the sexes. There have been myriad reasons for this lack of female inclusion. Science was heavily focused on studying the “norm,” and the “norm” as pertaining to scientific research was a roughly 155-pound man. Moreover, it was believed that the only difference between men and women were their respective sex organs. Furthermore, concerns regarding testing on pregnant women, or potentially-pregnant women, and the harm that could happen to fetuses discouraged researchers from including women of child-bearing age, and sometimes women as a whole due to their changing hormone cycles.

However, those assumptions finally began to change, albeit slowly, in the later decades of the 20th century. In 1985, a report released by the Public Health Service Task Force on Women’s Health Issues concluded that “the historical lack of research focus on women’s health concerns has compromised the quality of health information available to women as well as the health care they receive.” Founder of the Society for Women’s Health Research (SWHR ®) Dr. Florence Haseltine, MD, PhD, was working for the National Institutes of Health (NIH) in the mid-1980s when she began championing the need for medical research that recognized differences between men and women. She eventually coined the term “sex-based biology,” essentially meaning the study of the sex differences between men and women and how they apply to different aspects of medical research and health. Dr. Haseltine worked to confront different ways in which this inequality was manifested, including by advocating for more women to be included in clinical trials. Despite the fact that the NIH had recognized that inclusion of women in clinical trials is essential, they still aren’t always included.

These revelations sparked action by government agencies including the NIH, the Food and Drug Administration (FDA), and the Congressional Caucus on Women’s Issues. But it correspondingly also sparked the need for an organization that could champion the cause of sex-based biology head on. The Society for Women’s Health Research (SWHR) was founded in 1990 to “bring attention to the lack of inclusion of women and minorities in medical research and clinical trials.”

While progress has been made in including women in scientific research, there’s still substantial work to be done. Women and minorities remain underrepresented in clinical trials and medical research.

Why is it so important that sex differences are taken into account in medical research?

Put simply: men and women are biologically different. Health differences between men and women range from a prevalence of a particular disease, to the ways in which it manifests itself, to the drugs used to treat it. For example, SWHR focuses on Alzheimer’s Disease and Cardiovascular Disease (CVD) as two of the many illnesses that deserve a look through a sex-based biological lens.

Alzheimer’s Disease

Alzheimer’s Disease is one example of a condition that disproportionately affects women. In fact, women are almost twice as likely to be affected by Alzheimer’s as men. Overall, it is the fifth most common cause of death for American women. This increased prevalence for women isn’t just coincidental. There are specific sex differences that need to be taken into account when it comes to the study of how and why Alzheimer’s Disease strikes some and not others. According to experts at SWHR’s Alzheimer’s Roundtable, there are many different factors to consider:

Women suffering from depression have a 90 percent increased risk compared to men and an even greater risk after menopause, due to decreased estrogen levels. Another risk factor is having a hysterectomy and ovaries removed. Women who remove their ovaries before the age of 48 have a 70 percent increased risk of developing Alzheimer’s. However, if that woman used estrogen hormone therapy until menopause, she reduces her risk.

In order to prevent the devastating onset of Alzheimer’s–which is estimated to affect 15 million people over the next 15 years–it is essential to understand what role sex differences play and how women’s physiology can make them, in some cases, more susceptible.

Cardiovascular Disease (CVD)

Despite popular perception about its frequency in the male population, cardiovascular disease (CVD) remains an acute problem for women. In fact, CVD accounts for one in three deaths among American women–more than all cancers combined.

It’s also another example of an illness that can manifest differently between men and women, and has different risk factors. For example, CVD appears on average seven to 10 years later for women than men. There are also risk factors that are more visible for women than men, such as the fact that young women who smoke are at a higher relative risk for developing CVD than men who smoke.

Moreover, the way that CVD presents in women can be different than in men–sometimes leading to a failure by healthcare professionals to detect symptoms in a timely fashion. Women’s symptoms can include fatigue and indigestion, and can appear up to a month before a heart attack. These differences can also lead to misdiagnosis when a woman is actually experiencing a cardiac event–a study in The New England Journal of Medicine found that women under 55 were seven times more likely to be misdiagnosed than men. It’s important that researchers and doctors consider how not only different sex-based risk factors contribute to CVD, but also how different symptoms present themselves.

Another issue with a male-centric view of CVD is that symptoms that are more prevalent for men have been more widely publicized and focused upon in public service campaigns. As a result, women may not recognize the symptoms or risk factors themselves–the following video created by SWHR highlights some of the gaps in public knowledge:

Continued Underrepresentation in Clinical Trials and Research

It’s evident that progress has been made in including women in clinical trials–particularly when it comes to specific topics like heart disease and breast cancer. However, there’s still much work to be done. As recently as 2014, the FDA moved toward greater transparency in disclosing the sex breakdown of those who participate in clinical trials. However, that news was bittersweet–it confirmed long-standing concerns about the inclusion of women in clinical trials. SWHR released a statement about the FDA’s disclosure, stating:

We commend the FDA for the effort in collecting and releasing these data to the public and we believe it is an initial first step towards reducing the disparities and lack of information on sex and ethnic differences. But as is evident, the percentage of minority participation is dismal and while there are women in all of the trials, the numbers are not statistically significant to reach any clinical relevance.

So, where are researchers still struggling when it comes to including women in clinical trials and research?

Cardiovascular Disease Clinical Trials

While the risk of CVD has been well-recognized by proponents of sex-based biology, and women have been increasingly included in studies about cardiovascular disease, there’s still a struggle to make sure that studies report on gender differences. According to a 2009 paper by the American Heart Association (AHA) on the “Status of Women in Cardiovascular Clinical Trials,” both government and non-government studies continued to fail to report on sex differences in CVD studies between 2000-2006. The AHA stated:

An analysis of trials included in Cochrane meta-analyses (Cochrane Systematic Reviews) for the inclusion of women in cardiovascular clinical trials and for the reporting of gender-based analyses showed similar results. Of 258 clinical trials studied, women constituted only 27 percent of the pooled population and of 196 trials which included both genders, only 33 percent reported gender-based outcomes. When analyzed by year of publication before or after 1993, there was no difference in the frequency of gender-based analyses.

In order to ensure that the differences in the ways that women and men present and experience CVD are taken into account, reporting on sex differences in clinical trials needs to be a priority.

Conclusion

There’s no doubt that we’ve come far in this field and an improved concentration on exploring sex-based biology has resulted in a better understanding of sex differences–but we need to continue to such efforts in order to promote good health for all men and women. Clinical trials need to be designed to ensure not only the inclusion of, but also the recognition of their differences. Working toward inclusivity of medical research will benefit us all by increasing our understanding of what causes various illnesses and how to treat them.