Solving the Global Problem of Uterine Fibroids - Introduction

The following is the introduction for a forthcoming comprehensive medical essay on uterine fibroids (UFs) and their treatment. It is based on a review of 130 medical journal articles.

 

Solving the Global Problem of Uterine Fibroids 

Background, Rationale, and Introduction

            Except for diseases caused by a nutritional deficiency, no single discovery or therapeutic breakthrough can completely cure a disease. This essay provides the scientific basis to support the use of a safe, affordable, effective nutritional combination therapy to help prevent, retard, and reduce the incidence and symptoms of uterine fibroids – UFs - medically known as uterine leiomyomas, or simply, myomas. This proposed combination therapy consists of three medicines that previously have been scientifically shown to be effective in shrinking fibroids or inhibiting their development. Those are vitamin D3, curcumin (turmeric), and selenium. Together they can be referred to as DCS therapy, and cost about $100 per year. This should be essential preventative medicine for premenopausal women.   

            Uterine fibroids present one of the most impactful and costly health challenges in the world. Despite that, leiomyomas mostly fly under the radar in discussions of health due to their culturally sensitive, sexual, but non-transmissible nature. Still, there is an urgent need to conduct controlled clinical trials to reconfirm the efficacy of each of the above three nutraceuticals to fine tune a safe, effective, affordable combination therapy to prevent and shrink leiomyomas and significantly reduce their myriad symptoms. However, the economics of the American healthcare system mitigate against developing and implementing a low-cost, effective solution for UFs. That is because governments provide no incentives to do so. Instead, by failing to establish a mechanism to do so, they erect roadblocks to retard progress on improving women’s health. That obstruction is enormously expensive and self-defeating given the fiscal burden UFs put on the health care provider of last resort, state and federal governments. It represents the exact opposite of the often promoted both conservative and progressive goal of “affordability”.   

            By age fifty, a large majority of women in the United States develop uterine fibroids. Leiomyomas are non-cancerous tumors that often cause considerable pain, discomfort, emotional distress, infertility, and major problems in pregnancy. They have a serious negative impact on quality of life and personal finances. Although in most women UFs are subclinical, asymptomatic, and go undiagnosed; fibroids severely adversely affect the health and quality of life of approximately one-third of women who develop them. When their incidence peaks about age fifty, at menopause, uterine fibroids are as common in women as prostate cancer is in men over seventy. In the U.S., by age fifty, approximately 70% of white women and almost 85% of black women have developed uterine fibroids. Asian women experience a slightly lower incidence. (Baird) However, due to the variability of their number, size, and orientation in the uterus, only about a third of women who develop myomas experience noticeable pain, discomfort, and other moderate to severe symptoms.

            Although a minimum of two-thirds of American women have, had, or will develop uterine fibroids, most will remain asymptomatic, experiencing no serious negative effects. But one-third will suffer severe health consequences. So at least 22% of American women, approximately thirty-seven million, will eventually suffer significant symptoms. That amounts to one million women in Virginia alone, and close to a billion women worldwide. Unfortunately, this disease has not received the priority it deserves from the research community and potential safe, affordable, preventative therapies that could help alleviate women’s suffering have not been fully examined and clinically tested. They are too cheap. This systematic failure is partly because myomas are rarely fatal, despite being painful, expensive, reproductively problematic, and often debilitating. This essay addresses that critical need. It proposes a clinical trial platform that could quickly remedy that structural failure in the medical research system and rapidly advance our scientific understanding to confirm safe, effective, affordable complementary therapies to alleviate myomas. Those should be added to the current, woefully insufficient, standard of clinical care.          

            Uterine fibroids are the most common cause of hysterectomies. They are the second or third most common causes of female infertility, birth by Caesarean section, miscarriage, and premature birth. Although uterine fibroids are one of the most common disease conditions in women in America and cause numerous uncomfortable symptoms, they are seldom publicly discussed. Leiomyomas fly under the radar of many health advocates, while non-surgical approaches to their treatment remain grossly inadequate and under-researched. Despite promising scientific leads, these potentially effective preventative therapies are ignored because with zero commercial incentive, critically important clinical research never stands a chance. While UFs place a physical, emotional, and economic burden on millions of women, most men remain oblivious to this common condition that levies a huge financial cost on society. Statisticians estimate that in the United States, the economic cost of leiomyomas is more than $34 billion annually. (   ) As women suffer, health authorities and political leaders ignore promising low-cost remedies and preventative therapies. That is because the medical community accepts the status quo and no one wants to upset the profitable applecart of hysterectomies that cost $10-20,000 each, but with complications can cost up to $100,000 a pop.  

            As a health researcher, I first became aware of uterine fibroids when I owned a company that distributed selenium nutritional supplements to almost two thousand local pharmacies in six countries in Southern Africa. On a sales trip to Swaziland, now Eswatini, I visited a small rural pharmacy up a dusty, heavily rutted, red dirt road, a quarter mile off the paved two-lane highway that circles the northern half of the country through the immense sugar cane plantations owned by the King of Swaziland. Talking with the pharmacist-owner of this tiny, rustic pharmacy, she told me about one of her customers who had reported she had been suffering from “bleeding fibroids”. However, soon after taking selenium supplements her customer’s excessive menstrual period bleeding returned to normal, and the size of her fibroids shrank significantly. The woman’s physician was shocked and asked what she had been taking. She informed her doctor she was taking SAM selenium, the brand name of my product. That pharmacist’s anecdotal report intrigued me because, as an AIDS researcher and health advocate, I had never heard of uterine fibroids, much less bleeding fibroids. After attending the African First Ladies Conference on Ovarian Cancer in Lusaka, Zambia a few years earlier, I was aware of that other, indirectly related woman’s health issue. But numerous customers who had taken SAM selenium reported that the selenium supplements helped reduce their period pain and excess menstrual flow. Never having studied gynecology, I failed to make the connection to myomas. Only that one woman pharmacist in Eswatini ever mentioned the words uterine fibroids to me.

After returning to the U.S after twenty years in Southern Africa, and almost ten years after my introduction to the problem of fibroids, I watched a news segment on the PBS News Hour that discussed the issue of UFs and the need for more research into better treatments. That interview jogged my memory of that intriguing anecdote about the dramatic symptomatic improvement by the woman who lived on the sugarcane plantation in Eswatini. Always intrigued by unresolved medical questions, and gaps and blind spots in medical research, I immediately plunged into a deep dive into the medical journal articles that might explain the mystery of uterine fibroids, and potentially explain how selenium supplements may or may not help treat them. A complete review of the journal literature, including more than 130 articles also revealed how much progress has and has not been made in solving the problem of this vexing female malady, and how science has or has not improved therapy for this impediment to fertility, successful pregnancy, maternal health, and women living healthy, pain-free lives.              

            While conducting the comprehensive review of the medical journal literature on leiomyomas, I remembered another anecdote from my two decades as a selenium supplement distributor in Southern Africa. This story originated in a pharmacy on the main highway in a two traffic-light, rural town in upland Eastern Cape Province, South Africa. After I entered that old-fashioned, small-town pharmacy and greeted the pharmacist, a front-shop assistant enthusiastically called me aside to follow him into the cramped stockroom. There, sitting on cheap plastic chairs, he pulled out his wallet and proudly showed me a picture of his “selenium twin” babies. He explained that he and his wife had been trying unsuccessfully to conceive a child for six years, to no avail. No matter how hard they tried it was not happening for them. They were so frustrated. Then his wife brought home a bottle of SAM selenium she had bought in Johannesburg. He related that he and his wife were both taking the selenium and within a couple of months she became pregnant. They were over-the-moon when nine months later their selenium twins were born. He expressed how grateful he and his wife were for that blessing. Obviously, because livestock breeders use selenium to improve fertility and reproductive health in cattle, pigs, and chickens, it helps with humans as well. Selenium supplements should both reduce the need for and improve the effectiveness of in vitro fertilization treatments. However, here again is a competing special interest that gains by maintaining the status quo with high-cost in vitro fertilization – IVF – costing $15-30,000 per cycle. Frequently, more than one cycle is required to establish a pregnancy. $12 for a bottle of SAM selenium in South Africa was a relative bargain for successfully improving fertility.   

Selenium is well known and widely used in animal husbandry as an additive in animal feed. It improves livestock health and reproduction, and egg production in the poultry industry. It improves both male and female human fertility and is highly concentrated in the male testes. In times of selenium deprivation, in addition to the brain and thyroid, its levels are highly preserved in the testes. Selenium facilitates male fertility in part because the structural molecules that attach the head of the sperm to its tail include selenium. Without enough selenium the tail breaks off, preventing the sperm from completing its mission to fertilize the egg. Selenium supplementation also increases spermatogenesis and sperm count. It improves female fertility not only by reducing the negative impact of fibroids, but also through multiple enzymatic and hormonal mechanisms, including increasing thyroid hormone. Science has established that selenium improves both fetal and maternal health via several mechanisms and reduces the incidence of many pregnancy problems including Caesarean section, miscarriage, premature birth, low birth weight, and preeclampsia - high blood pressure. (   ) Theoretically, it might help alleviate postpartum depression. Because uterine fibroids have such a devastating direct impact against maternal health in so many ways and selenium supplementation is beneficial against those same impediments to successful pregnancy and maternal health, it can be theorized that selenium supplementation provides that panoply of benefits in part through its effect in reducing UFs.       

Despite years of research, there has been a general failure to make any great leaps forward in therapeutic progress in the clinical treatment of myomas. Instead, there has been a slow, gradual reduction in reliance on surgical remedies to resolve serious cases of UFs. Conceptual paradigms that artificially limit research to only new drug development and the failure to think outside boxlike research silos have allowed UFs to remain unchecked as one of the leading causes of hysterectomies, infertility, Cesarean birth, and miscarriage – at tremendous economic cost to society, and pain and stress for women. The failure of medical science to address this complex health problem more directly and holistically burdens women, families, and society with serious physical, psychological, economic, and lifestyle impacts that beg for improved therapeutic solutions. Thus, we need a more enlightened, inclusive approach to clinical research, preventative health and health maintenance that develops and refines improved complementary treatment combinations and attempts to prevent or slow development of UFs. We must rectify the mistake of exclusively focusing on new drug development if we ever expect to cut the Gordian Knott of how to reduce the impact of uterine fibroids on fertility and women’s health. This article illuminates that challenge and provides new perspectives on this problem. Among other things, it bridges the gap by outlining some of the common causal pathways of both fibrosis and fibroids. As the key chemical element required to improve immune system function, selenium is central to that understanding.

A  new clinical research infrastructure designed to test off-patent drugs and nutraceuticals for repurposing is needed to conduct controlled clinical trials of medications that have already shown efficacy or theoretically should show efficacy against uterine fibroid disease. As mentioned initially, those medicines include vitamin D3, the anti-inflammatory curcumin, and selenium – DCS combination therapy. Due to the undue financial influence of the pharmaceutical industry that receives billion-dollar tax incentives from the state, government policy continues to skew the healthcare system to solely incentivize expensive, pharmaceutical new drug development. That approach costs thousands of times more than drug repurposing and takes ten times as long to achieve successful efforts at new drug discovery. Still, outcomes often remain non-productive. Government policy continues to ignore the spectacular potential for sensible, low-cost, generic and nutraceutical solutions to stubborn health research challenges. That deprives every individual and every family of existing, safe, and currently approved potential therapeutic solutions, not only for uterine fibroids, but for scores, perhaps hundreds of other medical conditions as well. Americans are all poorer and sicker as a result. This represents the opposite of good public health policy. It contributes to the fact that Americans spend twice as much on healthcare per capita as most comparable advanced nations but end up near or at the bottom of international rankings on many measures of health outcomes. Some might consider this the worst of all possible research worlds. For the sake of all women and all Americans, this needs to change.

The Virginia Institute for Clinical Health Research – VICHR – to study drug and nutraceutical repurposing would be a valuable, low-cost solution to cut this Gordian Knott of intellectual intransigence and advance effective treatments for uterine fibroids, sickle cell anemia, and scores of other diseases. Only inertia due to the institutional self-satisfaction with the status quo, protected by special interest political contributions, stands in the way of rapid advances toward therapeutic improvements for myriad common illnesses including minority and women’s health, and cancer. That investigational stagnation will end only when leaders summon sufficient political will to achieve real affordable results by placing the people’s health ahead of corporate interests and their tax-break insuring campaign contributions. As long as we fail to reconfirm the science, women worldwide will continue to suffer.