women's health - Page 8

Why Men Should Care About Women’s Health

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To All the Men –

Over the past twenty to thirty years our medical and technological understanding has grown by leaps and bounds. From barely grasping the full effect of various hormones and chemicals in the brain to mapping the hormonal origin of the ability to nurture. We’ve made amazing strides and among these strides has been women’s health and medicine.

Just a few decades ago many men concluded their interest into women’s health with the attitude that we’ll just never understand a woman.

For centuries we have held her body as a mystery. For romanticism that serves a beautiful purpose, but in reality it creates far more problems for the women to which we adorn with such awe. Many times I have heard of gruesome historical stories relating to what some called modern medicine and others called butchery. Back then, by their standards, that was on some low level acceptable. Today it is not. The good news is that modern medicine and technology has brought us a long way to care for our women far better than our forefathers ever could. As a man I try to think forward to the possibility of having a daughter of my own. Part of my role in providing security for her is growing in my understanding of her health.

As men, it should be one of our chief concerns to obtain a significant and ever expanding knowledge base of women and their health as they are our sisters, mothers, wives, and most importantly, our daughters. Today there has been more progress in breast cancer and various areas of illnesses afflicting women than in any time in the history of our species. It is worth mentioning because it has resulted from a multitude of men and women and their tireless effort.

Oxytocin

With advances in medicine and our understanding of women’s health, we now understand a large part of what naturally makes a woman Mother Nature’s chosen nurturer. We understand the “bonding hormone” called oxytocin. Oxytocin is a hormone that both men and women produce but is produced much more in women during their younger years than in men. This is the hormone responsible for giving a woman the want and need to build incredibly strong and long lasting intimate bonds with their babies and spouses.

A wonderful example of the oxytocin difference in men and women is demonstrated in sex; immediately after sex a woman’s level of oxytocin increases far higher than her partner. There is a longing to be close afterwards and this closeness makes her feel a stronger and more intimate bond beyond just the act of sex. This hormone is also increased after childbirth causing women to have an incredibly strong bond with their newborn. With men it’s almost the complete opposite. We create the same hormone but in much smaller quantities in our younger years. As we age our levels of oxytocin increase making us want closer relationships and bonds with our children, grandchildren, and spouses.

Oxytocin is only a small aspect of women’s health but the reason I point it out is, thirty years ago it was virtually unknown. Other illnesses like breast cancer take center stage and we have thrived to provide an incredible amount of research and options so that breast cancer is an illness that claims fewer lives year after year. Today it is a fight that our women (and a small amount of men) can win.

This is Just the Beginning

There is still much research needed. With research into oxytocin maybe we can understand abnormalities that may result from a low level of this hormone. When a woman suffers emotional trauma, does this hormone become deficient? If so, it would explain why some women who survive emotionally and physically traumatic events struggle to create that bond with their husbands and sometimes their children. Do rape victims produce less oxytocin? If so, how do we help them? What is a normal level and how do we fix this problem. These are just a few of the questions we need to find answers to. New doors that once opened will lead to better lives, relationships, treatments, and medical procedures for women.

As a man, I can’t speak as a woman would about women’s health; however I can speak as a man should. It is our duty as men to help care for and help provide security for our women. To help strengthen them so that they can live out their lives in the most meaningful way they choose. To support them and help them find answers to the problems that plagues them. In doing so we enrich our future and we do our part to better understand what we cherish the most – our women.

 

About the Author:
John-Brandon Pierre is a United States Marine who has served for eleven years and counting. After motivating individuals in one of the most stressful organizations in the world, both in and out of combat, he became a motivational speaker and life coach. His philosophy is that life has a clear way of testing our fortitude and resolve, and it is through adaptation and perseverance that our species has survived over time. He helps individuals adapt to life through perspective to overcome the obstacles life. Originally from Texas, John-Brandon lives in San Diego, California and keeps a blog at Real World Motivation.

Why Few Women Trust the FDA

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Critics of Lucine and our e-journal Hormones Matter often suggest that we are biased against the pharmaceutical and medical device industries and that, we should trust the FDA on all matters of women’s health. After all, we wouldn’t want to be considered one of those wacky conspiracy, alternative health blogs or a bunch of mommy bloggers (for reference, I rate moms as some of the best arbiters of BS when it comes to health). Admittedly however, much of the information on the blogosphere is horribly slanted or so devoid of actionable intelligence that it offers no more than pablum – even from the more reputable sources. But I digress.

With those criticisms come claims that begin with the ‘FDA approved…’ a particular treatment or device, or ‘after reviewing the data, the FDA found no merit to’ research suggesting that a certain drug or device was indeed dangerous. I have to admit that it often feels like I am biased. Perhaps I am little less apt to trust this industry or the regulatory oversight than others. I am certainly wary of the magic pills (oral contraceptives, HRT, anti-depressants) that are marketed as cures for all that ails the female population (without supporting data). But then, just when I think it is safe to trust again, reports like this come to light.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered

Bloomberg News reported last week that Johnson and Johnson (J&J) continued to sale Gynecare Prolift, a vaginal mesh implant, for a full nine months after FDA ordered it to halt sales. Prolift is a surgical mesh device used to treat pelvic organ prolapse, a common condition in women who have had children.

The basis of the complaint was the five-fold increase in death and serious injury associated with this product.

Bloomberg News reports:

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

J&J determined the safety of this product on its own. Called ‘equivalence’ this is a common form of FDA approval requiring the applicant show merely that a device or test is ‘equivalent’ to some older, previously approved device or test. With low risk devices or tests this is a mostly reasonable way to garner approval. In higher risk devices, however, such as those that are surgically implanted, meeting equivalence is hardly sufficient for approval, especially if the older devices are themselves, dangerous or otherwise inadequate.

While the FDA ultimately “…disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter…” to halt sales, this was 2 years after J&J had already been selling the products to surgeons. By then hundreds of millions of dollars had been made and tens of thousands of mesh products had been implanted in women. J&J ignored the letter and continued to sell Prolift.

What’s worse than J&Js blatant disregard for the human safety is that the FDA ultimately caved and cleared the product in 2008, despite the fivefold increase in death and serious injury. Even a halted clinical trial failed to incite sufficient motivation to remove this product from the market. In 2009, the clinical trial designed to evaluate the safety of Prolift was halted when researchers found that >15% of women experienced erosion. Erosion of the mesh caused “pain, scarring, painful intercourse, bleeding scarring and closing of the vagina eroding into the bladder and bowel. Mesh erosion through the vagina is also called exposure, protrusion or extrusion. Many of these problems required additional medical or surgical treatments and further hospitalizations.” Despite the findings of the clinical trial, the products remained on the market.

As of 2010, J&J had reported sales of $295 million in the US alone. J&J did agree to re-label the device and in 2011 the FDA began considering re-classifying vaginal mesh products from a moderate risk product to a high risk product. I guess we should be grateful (insert snark). In the mean time, women continued to suffer and die. It is only recently, after hundreds of lawsuits, that J&J applied to recall Prolift and other vaginal mesh products. According to a J&J spokesperson:

“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,” 

Notice, that it was market factors, not product safety, behind the decision. The report goes on to say that products will be phased out on a region by region basis over the next year. I guess there is no rush to recall these products since J&J admits no health or safety concerns and the FDA approved the product. I sure would hate to be the last region in the recall.

So no, I do not trust the FDA to protect my health. I am afraid many other women, some of whom are mommy bloggers (yes, I am a mom and I blog), scientists and proponents of better health don’t either. Yet, we still must make decisions that affect our health and our family’s health. To all the women responsible for family health decision: verify, then trust.

Resource to Verify Medication Safety

AdverseEvents.com : this is a fantastic site run by a private company that allows individuals to list and view adverse events and side effects for every medication on the market. It is free to the user.  If you are an  Yaz, Yasmin or Ocella user, I encourage you to look up those medications and compare their side effect profiles to other drugs. This site does not list medical devices. If any of our readers know of a similar site for adverse events associated with devices, please share.

 

 

Subtle but fundamental changes in discourse: is anyone listening?

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Discourse Matters

What happens when we change the definition of a person to include everything from a corporation to a barely fertilized female egg? What happens when the corporate person and a collection of cells have more tacit and actual rights afforded than actual sentient beings? Though the loud and often offensive debates over a woman’s manifest right to make decisions about her health have led many to declare a ‘war on women,’ these same trends will serve to erode human rights in general- even for male humans.

Perhaps more of a philosophical question at this point, but when the definitions of words within a language dissociate so radically- person no longer means a human- it is difficult not to wonder what ramifications are before us; the law of unintended consequences will most certainly be at play here.

The Subject in Discourse

Language, and by association conversation or discourse, follow some very specific rules. At the most basic level, a sentence contains a subject, verb and object and, for the most part, words describe something about reality. (We’ve long since dissembled language and reality with mega marketing, political expediency and spin- but that is another topic altogether).

Subjects are usually, he, she, it, they etc., a person or thing.  Although the definition of person has evolved over the course of history, it is generally allied with some underlying concept of sentience or thinking. Even though animals can think, we have never defined animals as persons (try as many dog lovers might) and there has always been a clear demarcation between human and everything else. Over the course of two years, however, cultural forces have rendered that definition virtually obsolete. And we have yet to settle on a new definition.

Corporate Privileges in Discourse

By law, corporations are now afforded some of the same (often more) rights than human persons. A corporation is comprised of human persons, but is essentially a contrived legal entity that allows business to transact. What does it mean when a legal contrivance becomes a person? Because corporate persons often have more power and money, there is the very real risk that their market goals will supersede basic human rights. (As a countervailing force, however, the millions of people within corporations connected socially online may overturn this overstep- see my last post).

The Risks of Anti-Abortion Discourse

Similarly, local anti-abortion supporters aligned with local government entities have pushed legislation across multiple regions of the US that grant a fertilized egg, person status; often affording the cell person more rights than the human person. Along with these trends, legislation that either forces women to undergo unneeded medical procedures and/or prevent physicians from providing medical information to women supersede the rights of the human-sentient person in favor of cells. No matter what you believe about abortion, this is a fundamental shift in discourse with significant policy ramifications.

Aside from the potentially life-threatening position a woman can now be placed in legally, aside from ethical quandaries these laws place a physician in and the very real medical malpractice suits that these laws open the physician up to, this shift in language, motivated by narrow political goals, removes the notion of human rights, human persons, from policy discussions. And although, these policies currently target women specifically, they will ultimately erode rights for all humans. Who is to say other cells or other legal or object entities don’t indeed deserve to be protected over the rights of humans.

Sperm cells for example, are core constituents of human life and until we master asexual reproduction, why shouldn’t all sperm cells be considered sacred and merit the same protective caveats as the female egg?  Or to its absurdity, the male penis, testicles and the like, containers of this life-giving force, why shouldn’t they be enshrined and protected until the moment of copulation- a chastity belt perhaps?

Laugh as we might, redefining personhood to include everything from non-human, legal entities to a collection of cells that may or may not evolve into a human being, dismisses the role and rights of actual humans. This change in discourse is a dangerous slope.

Redefining Healthcare for Women

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As the dust settles on the Komen Foundation decisions of last week, I am reminded once again how compartmentalized and politicized the notion of women’s health has become.  Boobs and wombs seem to represent the sum total of interest in women’s health.  And if the Komen fiasco is any indication, one can’t care about both, because where one stands or one’s employer stands on reproductive issues is now becoming the litmus test that permits or denies access to care. If you are a woman, that is. No such criteria exist in men’s health.

Women’s health is inherently political. We carry the responsibility of continuing the species. With that responsibility inevitably comes intrusion (no pun intended). We seem to forget, however, that women have cancer (not just breast), heart disease, diabetes, immune diseases and the whole host of illnesses that are unrelated to whether or not we bear children. Certainly, whether we have born children impacts these diseases, more so than many are willing to admit, but what we think about birth has nothing to do with our health and should have nothing do with our access to healthcare.

As a private organization, Komen has every right to change its mission. It has every right to fund only those organizations that align with their political or religious views. If it believes strongly in those views, then it should change its mission and hold to it.  However, Komen should be prepared for mass defunding from those who don’t share the same ideology. Early signs of this were evident last week.

There is no delicate or politically adroit way around this issue for Komen and other organizations who believe that views on reproductive rights trump a woman’s access to healthcare or an agency’s access to research funding. If that is the litmus test, however, then say so. Take the stand and own the results. Tell the world that your organization provides preventative healthcare, supports breast cancer research and other activities only for some women and only for organizations that share your views.

Then let the rest of us get on with the business of providing healthcare and research for all women.

Data Matter

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A dirty little secret in medical literature, systematic reviews are only as strong as the individual studies they examine. And when negative data are not published in the major medical or scientific journals, as is commonly the case, these reviews cannot help but be skewed.  A report by the British Medical Journal found that when outcome data were re-analyzed to include the unpublished data for 42 previously FDA-approved drugs, a whopping 93% of the outcomes changed.

All data matter, especially in medicine.  With systematic reviews and meta analyses, the gold standard in scientific publishing, researchers seek to make claims about a particular drug or health event based upon the totality of the published research. Physicians and other scientists use these systematic reviews to guide decision-making. Prescribing a drug based upon the positive findings of a systematic review gives one considerably more confidence than doing so based upon a few unrelated studies. When the systematic reviews are based upon insufficient reporting of negative or null results, the review is likely inaccurate.

Publication bias, as it is called in research circles, is a well known problem to many. By nature, scientific journals gravitate toward positive and novel results, in much the same way TV news reporting tends toward negative, salacious events. Both are clamoring for market share. Unlike in TV news, bias in the research industry can and does have serious consequences when medical-decision making rely on those results. Noted physician and medical blogger Harlan Krumholz, contends that medicine’s biggest threat is not some exotic virus, but missing data.

Case and point, when data about adverse events are withheld from publication, bad drugs, such as Vioxx are released into the market place and presumed safer than they actually are.  A similar scenario is emerging for Yaz/Yasmin. These birth control pills are currently facing a bevy of lawsuits  for some serious adverse events.

So what is one to do, who does one trust?  I don’t know the answer to that question, but I think that good first steps include transparency and open access to data and research. As a patient, this includes access to scientific and medical research as well as access to our own medical data. As we report in the stories below, access to research is at risk if the Research Works Act passes.

A next step is to demand all data be published in drug studies, the good, the bad and the ugly. The British Medical Journal reports, those data are available in many, but not all cases, through FDA and other repositories. However, culling and analyzing those data along side the published reports is no easy task.

Perhaps a third option, is post-market crowdsourcing. Granted, not the best option when dealing with potentially dangerous therapeutics, but in this new environment of empowered patients and big data, crowdsourced research is becoming more common. The organization adverseevents.com is aggregating patient-reported adverse reactions to medications. It’s freely available to patients and physicians globally. A myriad of other companies have come on the market in recent years to crowdsource the research for all sorts of medical conditions. These companies offer patients the opportunity to participate and learn directly from the research conducted. Unlike traditional clinical research, the data and results are not cloistered, but are open and readily accessible.

In the end it all comes down to data and how we use it to make decisions about our health.  I believe data matter. I believe data ought be open and accessible. What do you think?

Participate in Crowdsourced, Post-Market, Adverse Events Research

Take a few minutes to complete a survey about the medications and surgical procedures you have utilized. Take as many health surveys as are applicable and share the surveys with your friends. All surveys are anonymous and completely voluntary. We’re adding more surveys every month, so check back frequently or sign up for our weekly newsletter to keep abreast of the latest research news.

Take one of our health surveys:

Crowdfund Research on Medications that Matter to You

Lucine Health Sciences and Hormones Matter, are unfunded and run by Dr. Chandler Marrs along with a cadre of dedicated volunteers. We know the work we do is important and needed and so we’re doing it anyway, despite the lack of funding. We’re bootstrapped to the nth degree, but determined to fill the critical data void in healthcare, one study at a time.

We’ve set up an unsubscription model to fund our education and research programs. We call it an unsubscription because it is not really a subscription in the true sense. It’s just a mechanism to fund the work that maintains our commitment to open access health information on Hormones Matter.  By purchasing an unsubscription you are supporting our continued operations and research; research and health information we all need but can’t get anywhere else. To help fund additional research: Crowdfund Us.

 

Cortisol: The Stress Hormone

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Cortisol is a steroid hormone produced in the cortex of adrenal gland. It belongs to a class of hormones called glucocorticoids and plays an important role in regulating cardiovascular function, blood pressure, glucose metabolism, sugar maintenance, and inflammatory response. Cortisol is best known as the stress hormone. It is released in response to stress, and is part of the fight or flight system.

Under normal conditions the body regulates cortisol levels which are usually high in the morning and low at night. But under stressful conditions more cortisol is secreted. Small increases in cortisol produce positive effects such as increased sustained energy, diminished pain sensitivity or memory enhancement. But a prolonged cortisol increase during chronic stress results in negative side effects: increased blood pressure, sugar imbalance in blood, decreased bone density, cognitive problems, and reduced thyroid function. It also slows down healing processes and suppresses the immune system, perhaps the reason we are more apt to get sick when we are stressed.

Continuously, stress-induced elevated cortisol levels lead to an increase in the level of other hormones (testosterone, estradiol, insulin).  High cortisol levels are often linked to insulin resistance (Type 2 Diabetes), weight gain and general inflammatory conditions. High cortisol is toxic to the brain and can cause memory loss and contribute to Alzheimer’s disease or senile dementia. Elevated cortisol levels and lack of diurnal variation have been identified with Cushing’s disease. Low cortisol levels are found in primary adrenal insufficiency (e.g. adrenal hypoplasia, Addison’s disease).

Cortisol and progesterone bind to common receptors in cells. Cortisol blocks progesterone activity, and some suggest, that high levels of cortisol, initiated by chronic stress, dispose one to a condition called estrogen dominance.  Estrogen dominance is condition where women cease to ovulate regularly and progesterone concentrations are lower than necessary during the second half of the menstrual cycle. Many suspect estrogen dominance underlies PMS and other cycle related symptoms.

We Cannot Manage What We Do Not Measure

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Pay attention to the whimper or be forced to cry uncle. Those are your choices. Those were the choices that faced the nation ten and twenty years ago as naysayers to the economic policies certain to bankrupt our country became evident, but they were ignored or lambasted as fringe. The collective wisdom forged forward with derivatives, with the merging of investment and saving banks, against the whimpers of many, only to cry uncle in 2008 as the catastrophe loomed.

As the ‘other 99%’ seek to realign our political and economic situations, women must lead the changes in the health industry. We must pay attention to the whimpers, to the evidence that something is off, and more importantly, we must take heed before uncle is cried. How do we do that within such a flawed system of industrialized, profit-based medicine? Education, measurement, transparency and responsibility.

Education. The number one factor contributing to health is education. The more educated women (and men) are the better health they experience. Why? Better decision-making. Although there are clear associations between income and health, the association between education and health is stronger.

Education allows one to navigate the morass of medical marketing, cut to the truth, and identify the untruth in advertising. Education permits women the confidence to seek alternate directions in health and not simply take what is prescribed to them as gospel. Quite simply, education permits responsibility in health choices. It doesn’t necessarily lead to taking responsibility or making the right choices; we’ve all seen really smart, highly educated people do really stupid things. Rather, education creates the environment where those choices can be made.
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Unite Walking Uteri: Repair the Economic Moral Fabric, One Woman at a Time

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For a website devoted to women’s hormone health research, I seem to write a lot about the current economic and political situation. That may seem odd on the surface, but a deeper dive reveals an inextricable connection. The recession has forced American values into re-alignment and like or not, health is at the center. And women’s health, because we bear children, is at the nexus.

As a woman, who has born children, I take offense to the fact that in political, economic and healthcare debates, women have become no more than walking uteri. From both the political Left and Right, our choices to bear or not bear children seem to represent the sum total of the interest in our health. Sometimes our breast health is considered and on a rare occasion other aspects of our physiology enter into public discourse and even research, but mostly it is our childbearing that garners the attention.

Even so, the pretense that the debates currently dominating the public arena involve anything closely related to women or health is false. These are debates about money and power—getting it and keeping it– and we are simply the tokens of that economy. But we don’t have to be, because as walking uteri, they have failed to recognize one important point- we can walk the other direction.

Although we are only 50% of the population, we consume 80% of the medical care and we control the medical decision-making in most families – that is our power. The makers of HRT know this all too well.  They saw their profits drop by as much 70% when the unfounded marketing claims that HRT cured everything came to light.  Millions of women transferred their consumer purchasing power to the bio-identical hormone, nutraceutical and other health-related industries. As hospitals began dictating C-sections, a whole movement of home-birth evolved; home-birth in the 21st century- who could have predicted that?  As more and more toxins are found in our foods and especially baby products, companies marketing healthy, organic products are born. Our uteri are walking right out the door and creating entire industries that place health and well-being center stage.

So, while politicians covet big money from the corporations that obliterated the economy and decimated women’s health; while protestors protest the profligate practices of Wall Street (finally) and pundits decide which side of the ratings fence they are on, women are quietly re-building the economy. Inc.com indicates that women lead 40% of all business in the US (2010), but received less than 8% of investment capital. Perhaps as a result of the lower capital, we are better at bootstrapping, have higher growth, better returns and our businesses succeed more frequently than companies led by men. Our companies are less risky; none of the high-flying financial shenanigans that got us into this mess in the first place. Perhaps because of the inequities in healthcare and research perpetrated on women by men interested only in the functionality of our collective uteri, we’re building companies that address women’s health-beyond the uterus.  Companies like Lucine, and many, many others.

Are the attempts to de-fund women’s health important, even though they pertain to the most narrow definition of health? Yes. They serve as a reminder that we have more power than we think. We are the consumer market that matters. We can take our consumer buying power and our voting power elsewhere. We can create the industries that matter to us. In doing so, we repair what David Brooks called the ‘moral fabric of our economy.’

Hormone health research and diagnostics matter to me and my colleagues at Lucine. What matters to you?

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