The Transverse Lie
March 13, 2016 Update
As I continue my lonely fight with Congress against their inaction and apathy, the support from the highest levels of the medical community continues to come in. This gives me hope and provides an impetus to continue.
Most recently, the editor-in-chief of the British Journal of Obstetrics & Gynaecology (BJOG), Dr. Khalid Khan, touched base to let me know that things were moving slowly but surely in getting our Cochrane review ready for publication, which I co-author.
Though I'm technically a layperson in the area of medical research, having worked in tech my whole adult life, when I'd reached out to Dr. Khan last summer and shared the data I'd compiled over the course of a year and a half, following my own surgery, he listened openly, met with me while he was in D.C. for a conference, and returned to the U.K. to assign a fellow to look more deeply into the work I'd pulled together, and to initiate what's called a Cochrane database review.
Because I'm a person, and not a Cochrane database, I had been able to follow some unusual threads in my attempt to address some important and confusing study findings, such as why we who've had this surgery are at a doubled risk for lung cancer. I was able to explore the link between the loss of ovarian activin, a protein, and its role in lung alveoli regeneration. It's also linked to lung cancer and to breast cancer, and has both healing and harmful roles in the body. This kind of information formed the basis for the review. I'm very grateful to Dr. Khan and to his fellow, Martin, who've worked hard with me to generate the snapshot this review will provide.
Additionally, in February, I received feedback from two Mayo Clinic doctors whose work featured heavily in the studies I've compiled. Their reactions also made me feel incredibly proud and hopeful. Dr. Walter Rocca is a professor of both Neurology & Epidemiology at Mayo, and Lynne Shuster is an Internist there, as well.
I'd also received this from Dr. Parker from UCLA in July, but as he's more recently spoken in support of morcellation of sarcoma, his support has less weight than it previously had.
I should say, to be honest, that these responses are both heartening, and depressing, in the sense that Sen. Mark Warner has taken all of this information and allowed one of his aides, a young man in his early to mid-20s, Charlie Arnowitz, whom I'd met with along with Senator Warner's Legislative Director, Elizabeth Falcone, on January 8, 2016, to go into a meeting with the big guns from the American College of Obstetrics & Gynecology on his own.
Senator Mark Warner
And despite the fact that I'd provided Senator Warner, Elizabeth, and Charlie with over 500 studies supporting the concern that I and the entire medical field outside of OBGYN share, he responded with what feels like an obscenity and is certainly a dereliction of duty in email to me after their meeting. Despite being armed with hundreds of studies, Charlie thought it made sense to say that the "proof is in the pudding," and to keep it up, as though we can spare more time when this issue affects an incremental 60,000 women every month, or as though new information may come to light and it might be ok to remove a large portion of our endocrine systems.
I had spent over a year compiling massive amounts of data, and had presented it to Charlie in person. He was armed with hundreds of studies detailing the harm these doctors are doing. He had enough information not just about the harm, but about a massive cover-up, to require a Congressional hearing. Instead, a young aide has decided on a senator's behalf and on behalf of 15 million women in this country who've been made ill in this way in order not to disrupt a $25 billion (yes, "billion") per year hysterectomy industry.
His email sounds to me as though he thinks he's on the West Wing and is discussing some abstract policy issue. He sounds as though he feels that his intervention has somehow led to a compromise, as though a compromise is possible when harm is being done. I'm sure he felt very important calling that meeting with them...and he could've been, if he'd come away demanding an appropriate response. But, he didn't.
The Democratic senators, Warner and Patty Murray, who's also aware of the issue, are unwilling to protect the American public, and I've had to think long and hard about why that might be.
It took a FOIA request to unearth the fact that roughly 730,000 women are subjected to ovary removal surgery when they have no demonstrable risk of ovarian cancer, but the threat of cancer is used. 22,000 women are diagnosed with ovarian cancer of the 160 million women who live in the U.S., and 14,180 women die each year. That mortality rate did not decrease when the rate of ovary removals went up, so it's demonstrable, after 35 years of this practice, that it's not saving women from cancer, but it is making them very ill.
What's more, it's been known within the medical community that the ovaries play this other role - this endocrine hormone role - for our entire lives, and that it's ovaries' egg-producing, exocrine function only that stops at age 50 but the endocrine role certainly doesn't - for 100 years, so there is no room for conversations about "early or sudden menopause." We are not in menopause. Our bodies are vastly biochemically different. We are ill. As ill as someone with no thyroid gland. As ill as someone with no adrenal glands.
The Endocrine System - the link form the ovaries (female gonads) to the brain (hypothalamus & pituitary) is called the HPG axis. The adrenal glands and the thyroid gland are the only other glands that have their own axes to the brain. When the HPG axis is upset, we age prematurely and become ill. When it is gone entirely, chaos. Illness ranging from Parkinson's and Alzheimer's to heart disease and lung cancer, and ultimately - early death.
November 10, 2015 - Summarizing the issue - broad picture of OBGYN lack of training and oversight
- On the arcane scale, 'little known facts about ovaries' might seem like a 10, but, in fact, they matter greatly to the 15 million women in the U.S who have serious illnesses and have no idea how directly those illnesses are linked to the removal of their healthy ovaries.
- An increasing number of serious health issues have been linked to OBGYNs' lack of training in general surgery, and their surprisingly un-medical attitudes toward introducing greater risk under the guise of "patient choice."
- In a recent survey, half of OBGYN graduates were unable to perform the procedures includes in their accreditation.
- Women's groups note that no governing body, from the AMA to the Department of Health & Human Services, is overseeing the OBGYN specialty or keeping an eye on the statistics regarding harm and over-treatment. Hysterectomy, alone, is an unregulated $25 billion industry.
- At least 40% of all U.S. women have a hysterectomy by age 54, with about 830,000 performed in the U.S. every year. The percentage of U.S. women who have this surgery is far higher than in any other developed country. With a mortality rate of 1 in 1,000, 800 U.S. women die each year on the operating table during what is, about 92% of the time, a benign, non life-threatening condition.
- Studies have shown that OBGYNs perform hysterectomy not because it is the most appropriate choice for an illness like fibroids or endometriosis, but because their accreditation doesn't require them to learn other procedures. It's the old "if all you have is a hammer, everything looks like a nail" adage. OBGYNs must perform at least 70 hysterectomies to receive ACGME accreditation, but zero myomectomies, surgery to remove just the fibroids that are the reason for 40% of hysterectomies, or cystectomies, removing just the ovarian cysts that account for 300,000 sets of ovaries removed each year. In nearly every case, everything comes out every time. This is not a typical medical approach to illness.
- Few people realize that ovaries (or, in men's case, testes - both gonads) are both exocrine and endocrine glands, and are needed to take cholesterol and turn it into hormones for women's entire lives. Reproduction does not define the role of the ovary, and their role does not end at menopause. The role, instead, changes, and the ovaries produce more testosterone until the amount peaks when a woman is in her 70s, and levels off. Testosterone is more important to an aging body than estrogen because it's linked to lower fat, increased muscle, and stronger bones.
- OBGYNs remove over 700,000 women's healthy ovaries in the U.S. every year. Ovary removal is proven to cause or increase the risks of premature death, Parkinson’s, Alzheimer’s, dementia, cognitive impairment, memory impairment, osteoporosis/fracture, cardiovascular disease, stroke, arteriosclerosis, sexual dysfunction, lung cancer, type II diabetes and metabolic syndrome, depression, and glaucoma. The reasons for the diseases vary, but are all a function of the absence of a main component of the endocrine system, the gonads, in the case of women, the ovaries, which link to the brain via an axis called the HPG axis.
- OBGYNs are aware of the risks of removing ovaries, but remove hundreds of thousands of ovaries a year. Women believe this is done to lower their risk of ovarian cancer, and don't realize that they still need their ovaries. The ovarian cancer statistics aren't well-publicized, but fewer than 22,000 of the 160 million women in the U.S. develop ovarian cancer each year. OBGYNs have had to ignore significant data dating back a century in order to persevere with this practice. In ignoring data about the low cancer risk and the high risk of endocrine harm, OBGYNs are not practicing what's referred to as "evidence-based medicine," as other specialties do.
- For comparison, pancreatic cancer is both more common and more fatal than ovarian cancer. It is also just as difficult to detect. The pancreas, like the ovaries, is both an exocrine and endocrine gland. A patient could take digestive enzymes and insulin to survive without a pancreas, but no doctor would ever suggest removing a healthy pancreas "just in case."
- Regarding other risks they're introducing, when the ACOG learned that their morcellation (chopping up inside the body) of uterine fibroids could upstage a type of cancer called leiomyosarcoma from Stage 1 to Stage 4 in 1 in 352 women, an ACOG advisor to the FDA summed up their surgical attitude by saying, "I don't care if 1 in 10 women has sarcoma, I still say (we should continue to offer morcellation)."
- Though the FDA mandated a warning on morcellators, ACOG members interviewed went on record saying that they tell patients that the FDA's numbers aren't correct, thus corrupting the informed consent process
- C-sections in the U.S. increased a full 60% in the U.S. between 1996 and 2009. This was not due to women's request, but to OBGYNs' decision-making. Various articles have considered the cause for the significant spike in the surgery, and found that c-sections cost $20,000 more, on average, than vaginal deliveries, and are more convenient to schedule for doctors. The U.S. has the highest rate of c-section in the developed world, as well as very high infant and maternal mortality, for a developed country. The WHO has shared that a country's c-section rate should not top 15% of births. The U.S. rate is 33%.
- The removal of healthy ovaries is both harmful and discriminatory in its nature. It is not practiced in the equivalent as a method of cancer prevention method in men, despite the fact that that equivalent cancer occurs in twice as many men as ovarian cancer does in women
- The government's failure to address this harm and its presumption that a multi-billion dollar industry is necessarily benign has left the door open for the current situation with women's health. There is no question that over-treatment is evident in every procedure, from the annual exam, to the c-section rate, to hysterectomy and ovary removal. The subject comes up on a regular basis both in the news and in medical journals. The government's time to intervene is long overdue.
- This is not a question of regulation of medicine or introduction of new legislation. Harming people is already illegal.
- This is also not a question of limiting women's choices or control over their bodies. We don't offer harmful surgery to people and call that "choice."
- To understand what is being asked, it's important to imagine an analogous situation. What if a medical specialty were routinely removing healthy thyroid or adrenal glands? More simply, what if they were removing the healthy left hands of 700,000 people every year? And what if that were part of a multi-billion dollar industry? Would anyone imagine that we should step aside and allow that to continue simply because those doing the harm were doctors? If they can't be counted upon to self-regulate and confront the evidence in literally hundreds of studies, they must be forced to adhere to both the tenets of the Hippocratic Oath and the law.
- The Senate Committee on HELP, specifically Sen. Murray, Sen. Alexander, Sen. Sanders, Sen. Franken, and Sen. Warren, have all received our July 2015 letter and many phone calls about the ovary removal issue, but haven't taken any action that we're aware of. Sen. Mark Warner sent the issue to the FDA in August, but they are not the right agency since they only deal with pharma and medical devices. His staff set a meeting with the ACOG for early February, and we are hopeful that they will provide feedback shortly.
Congressman Connolly's office sent the issue to Dr. Nancy Lee, head of women's health within the Department of Health & Human Services, but there has been no response. Sen. Lamar Alexander responded saying he wasn't interested in our views about Planned Parenthood, though we hadn't mentioned that issue at all. Sen. Tim Kaine's office didn't provide any kind of response. Governor Terry McAuliffe's office sent the issue to the Virginia Dept of Health in August, but we've had no response.
- The U.S. government does not require any more studies in order to understand the harm that's done; they need only take a moment to read the hundreds that have already been published. What we need is action and a government that cares about women's health beyond reproduction.
- We require a Congressional hearing and a ban on ovary removal in women without demonstrated risk or existing cancer. This must take place ASAP. What is the basis for this? Not new legislation, but application of the law to all people, including doctors. It is illegal to harm people and it is of special interest when those we've entrusted to look out for our health are knowingly harming patients and enriching themselves in the process. The current legislation is sufficient to address what's happening to women today. It need only be applied.
Citations for all information can be found inline, below, and here.
How would we perceive this behavior in another country?
What would Americans think of a country where their physicians were increasing the risk of Parkinson's disease in over 2,000 women every single day? Would they condemn that country's treatment of women? Or describe their medicine as third-world? Would their government be expected to intervene?
Increasingly, the question is being raised about America's OBGYNs, and the risks their surgical training and attitudes towards patient harm pose for women. Is insufficient training to blame? Or is it a refusal to confront and react to the results of evidence-based medicine? Whatever the answer, evidence shows that OBGYN surgeries of all kinds are increasing the mortality rate of U.S. women.
OBGYNs do not receive general surgery training
Though OBGYNs in the U.S. perform more major surgeries than any other specialty in medicine, their training differs from other surgeons in an important way. Where most surgeons train in general surgery for a minimum of five years, OBGYNs do not train in general surgery at all. Number of years: zero. For comparison, a plastic surgeon trains for at least three of their 5-6 years in general surgery. Instead, OBGYNs train in a silo, solely in their own specialty, for a total of just four years. (See the American College of Surgeons' write-up about surgical training and durations.) In the U.K., for frame of reference, OBGYNs train for seven years, nearly twice as long.
Why does this matter? It's during general surgery training that surgeons are indoctrinated with the belief that the patient on the operating table is the only patient that matters at that given moment. This is a belief most Americans assume their surgeon possesses, but has been proven, time and again, not to be a safe assumption in the case of OBGYNs.
This focus on OBGYN training, to the exclusion of broader general surgical training, would only make sense if it translated to total proficiency in the specialty, but that's not at all what the numbers say. In fact, both OBGYNs' ability to perform procedures upon graduation, and their subsequent decisions while on the job, are currently under the most severe scrutiny. In just the past year, the issues of robotic surgeries using a device called a morcellator, and the decades-old practice of removing healthy ovaries were sent to Congress by concerned patients whose health was harmed and whose concerns were met with inaction by the doctors. Morcellation has made hundreds of women's cancer incurable, and the removal of healthy ovaries is a little-understood American tragedy that has made over 15 million women in the U.S. today far more likely to die of heart disease, Parkinson's, Alzheimer's, and cancer than they were prior to surgery.
From basic surgical incompetence to over-treatment to increasing death by serious illnesses, it's clear that it is time for a re-evaluation of this medical specialty.
Half of accredited recent graduates were found to be unqualified
A group of OBGYN fellows had finished training and had gone on to the cancer sub-specialty, called "gynecological oncology". These doctors were recently evaluated by the attending physicians and program directors who were in charge during their continued training. The results of that evaluation were alarming, given the fact that these physicians were already supposed to be certified to practice, and were simply going on to focus on a sub-specialty.
49% could not independently perform a hysterectomy, 59% could not independently perform 30 minutes of a major procedure, 40% could not control bleeding, another 40% could not recognize anatomy and tissue planes, and, finally, 58% could not dissect tissue planes. The only reason these accredited doctors were not out in the field practicing already was their desire to go on to the cancer sub-specialty.
So, who is evaluating the doctors who went straight out into the field? Patients. More specifically, patients who are harmed. However, by then, it's too late, and as Medscape is quick to tell doctors, physicians need not worry.
"65% of malpractice claims were dropped, dismissed, or withdrawn before trial; 25% of malpractice claims were settled; 4.5% were decided by alternative dispute resolution; and 5% were resolved at trial, with physicians prevailing in 80%-90% of those cases."
Response to high risk of complications
So, why would half of the graduates be unable to perform a hysterectomy or operate alone? Why were they unable to recognize the anatomy they'd studied for four years? Good questions. After all, these were physicians who had already performed a minimum of 70 hysterectomies (see page 2) in order to become accredited. Unsurprisingly, OBGYNs' rate of major surgical issues once they are out in the field is very high. This was reported most recently in their 2015 Professional Liability survey results. According to Medscape, "before reaching the age of 40, more than half of OBGYNs have already been sued."
Americans assume someone somewhere is keeping an eye on something this important, but they're wrong. No other group, from the U.S. government to the American Medical Association, is overseeing these problems or addressing these concerns. It's up to the OBGYNs' own member organization, called the ACOG, or "the American Congress of Obstetricians & Gynecologists", to provide a response and to revise practice guidelines.
So, how did the ACOG respond to this new report? Revised training? Some other kind of reform? The ACOG chose to adopt a defensive posture, and, rather than addressing high patient risk, addressed their own high insurance premiums. Dodging the obvious link between a high rate of mistakes and high insurance premiums, the ACOG claimed that the scrutiny they're subjected to is forcing doctors to consider leaving the field, putting the delivery of U.S. babies at risk. The ACOG's president, Dr. Mark DeFrancesco, wrote a blog post in response to the liability report entitled, 'Who Will Deliver America's Babies?'.
It might be assumed that the risk is typical for mothers delivering babies all around the world, but it is absolutely not. According to Save the Children's 2015 'State of the World's Mothers' report, the U.S. has one of the highest rates of both infant and maternal mortality of any developed country, even higher than some very poor countries in the world. The U.S. is 1 of just 8 countries in the world where risk to mothers and infants is increasing rather than decreasing. In fact, Washington, DC, where the ACOG is located, has the highest infant death risk in the United States.
The idea that there won't be enough doctors to deliver babies is also simply not true. According to the Association of American Medical Colleges' figures, there appear to be plenty of OBGYNs to deliver America's babies, with more doctors than in any other group apart from routine family doctors. There are also more OBGYNs than in any other specialty that performs surgery, as well, which translates, not surprisingly, to millions of obstetrical and gynecological surgeries, almost all of which are elective, each year for America's women.
So, if we don't have to worry about doctor scarcity, we should be able to return to the real issue: if the ACOG is unwilling to confront the risks they're creating for their patients, when is some responsible organization going to begin looking into the drastically-high mortality rate associated with their surgical decisions?
Who is keeping score?
There appears to be a presumption by the Department of Health & Human Services, or "HHS", and other government agencies that everything is under control at the ACOG. In fact, the HHS accepts the ACOG's practice recommendations, and embeds them in their own website for patients and physicians to find, and HHS and Congress work closely with organizations like the ACOG on a regular basis. That presumption, on the part of the government, and its lack of oversight regarding the life or death decisions of a multi-billion dollar a year industry is a failure to provide checks and balances to a well-heeled specialty that has their ear, where the average patient does not, and has contributed to where we are today.
It's long been understood that OBGYNs are performing the number 1 and number 2 most common surgeries in the United States, c-sections and hysterectomies. Hysterectomy is the second most common surgical procedure performed on women, and involves almost half of the U.S. population by the time they turn 60.
The high number of these surgeries are, simultaneously, frequently-questioned and taken for granted simply because they're so commonplace. The c-section number stands right now at 1.3 million women a year. More about that later. But the number of hysterectomies in the U.S., which used to be reported regularly, has become increasingly hard to figure out, and matters both in terms of determining whether it's overused and to determine how many women's healthy ovaries are removed a year, since that figure isn't tracked separately.
Using data from the HHS, it's not easy to evaluate the exact risk posed because it's inexplicably difficult to arrive at the authoritative number of surgeries. In fact, America, as a country, spends more time analyzing data from football games in one week than it does women's surgeries in an entire year. If a little more work were done to dig into the numbers, would the government find out that the number of patients being over-treated is staggering? Or that the surgeries are increasing women's mortality in a number of ways? This work isn't being done, so here it is, laid out plainly.
More than 800,000 hysterectomies in the U.S. each year
To piece together how many hysterectomies are performed in the U.S. each year, we have to add the number of inpatient surgeries, tracked by the Centers for Disease Control, or "the CDC", within the HHS, to the number of outpatient hysterectomies, tracked by the Agency for Healthcare Research & Quality, or "the AHRQ", also within the HHS. All hysterectomies used to be inpatient surgeries, and that legacy has resulted in this inpatient number often being incorrectly cited as the total number of surgeries, but that's not at all the case today. In fact, it's only about 55-60% of the number, now.
Increasingly, hysterectomy has been done on an outpatient basis. Being an "outpatient" effectively has no meaning, and the way it's decided is pretty much up to the doctor. It doesn't mean that the patient doesn't stay overnight, just that she isn't formally admitted to the hospital. The only way to know for sure which category a stay fell into is to look at the hospital bill. This decision has more to do with what insurance pays than with anything else.
The outpatient hysterectomy number is on the rise, largely due to the use of a robot to perform the surgery in a way that's appealingly referred to as "minimally-invasively". Instead of an abdominal opening, as with a c-section, robotic surgery can be done through smaller ports in the abdomen. This is also done in lieu of the more traditional vaginal hysterectomy, which has been around for over a thousand years and doesn't involve opening the abdomen at all.
According to the annual report of Intuitive Surgical, maker of the surgical robot, called the daVinci, the robot's primary use is gynecological surgeries.
These outpatient surgeries, tracked by the AHRQ , are, for some reason, kept separate from the inpatient numbers, tracked by the CDC, and must be added together to begin to understand how many are performed each year.
Determining an accurate number is also complicated by two other issues. One is the fact that the numbers are all estimates, derived from information voluntarily reported by hospitals in a subset of U.S. states. The other is that the CDC admits that their number is an under-estimate, and perhaps a very significant one, because they include women who have already had a hysterectomy in what is called their "denominator" when they estimate the number of new hysterectomies each year. In other words, the whole thing is kind of a mess.
In 2010, the CDC reported that there had been 498,000 inpatient hysterectomies. In 2012, the AHRQ reported that outpatient surgeries made up 40% of all hysterectomies. The result, though we know it's an underestimate, is that there are roughly 830,000 hysterectomies in the U.S. each year, rather than the 5 to 600,000 number so often reported in articles and studies, where they're using that old inpatient number only. Sometimes, it's even reported that hysterectomies are on the decline in the U.S., because the analyst is mistakenly watching that inpatient surgery number decline, but actually, because of the robot and the appeal of the sound of "minimally-invasive" surgery, the number of hysterectomies has been growing.
8% of these surgeries are done to remove cancer or other life-threatening conditions, leaving around 764,000 hysterectomies which are done purely electively, meaning by choice for a condition that may be very painful, but isn't life-threatening.
That's a lot of surgeries, so it's no surprise that, according to the HHS, 40% of women between the ages of 45 and 54 (page 52) have had a hysterectomy. This percentage is far higher than it is in all other developed countries around the world. That should sound an alarm for the HHS and for U.S. women. After all, how could such a radical procedure be right for almost half of a country of 160 million women? More than twice as many hysterectomies per capita as British women and five times as many as Swedish women?
64 million women in the U.S. at this moment either have had or will have a hysterectomy. Currently, nothing is being done to address these numbers, despite research that as many as 76% of hysterectomies didn't meet the ACOG's guidelines as either necessary or appropriate. Every one of us knows several women who've had this surgery, so we take for granted that it's almost a rite of passage, which is something we don't do with any other kind of major surgery.
According to the Weill-Cornell Medical Center in New York's Dr. Ernst Bartsich, a gynecological surgeon,
"Our profession is entrenched in terms of doing hysterectomies. I'm not proud of that...it isn't necessary in so many cases...somewhere between 76 to 85 percent."
No such thing as a routine surgery
Nature is pretty smart. If a woman's body didn't need her uterus any longer, it would likely disappear on its own. Removing body parts that aren't incurably diseased is known as "over-treatment" in medicine. It's for that reason that doctors have, for the last several decades, begun to stand back and look at their own routine surgeries, such as tonsillectomies.
Hysterectomy may be very common in the U.S., but it is not a simple operation, whether it's robotic, abdominal, or vaginal. The uterus isn't, as we usually see it pictured, sitting alone in the abdomen, easily removed, waiting for its time to be cut away, but is deeply embedded with the other organs and tied to the body by both ligaments and arteries.
Because the surgery is so common, we often don't think about complications or mortality the same way we do with other surgeries, but as with any procedure, these are important considerations. In a 2001 study, they found that the overall mortality rate was 1.5 per 1,000, which is comparable to a cardiac bypass. Other sites put the risk at 1 in 1,000. Given that over 800,000 are performed in the U.S. each year, that's 800 women a year who die during surgery or because of a complication the surgery has caused.
Hysterectomy even without removal of the ovaries causes health issues for women that affect their internal anatomy, increase risk of enterocele, rectocele, bladder, and vaginal vault prolapse, all requiring future surgery. It's also known to diminish women's ability to have a fulfilling sex life for the 30 to 40 years after surgery due to lack of a uterus and sometimes cervix, and their role in orgasm. In addition, hysterectomy is known to increase women's risk of heart disease. For women hoping for relief from pain, and looking forward to a happy, confident sex life, these consequences, along with the failure of their ovaries and loss of their sex drive, often comes as a shock.
Hammers and nails
So, why are there so many hysterectomies? Because they're what the OBGYNs have been trained to do in order to become certified. Alternative procedures are not part of the doctors' accreditation, which means the doctors are not comfortable performing them, which in turn means that they are not offered to patients.
To put this in context, consider another type of growth, a kidney tumor. The entire kidney is never removed unless absolutely necessary. The illness is removed, and the organ is preserved to the extent possible. This is the case with all other forms of surgery, as well.
Alternatives exist. In the case of uterine prolapse, the uterus can be tightened up, using its own ligaments. In the case of endometriosis, it can be removed from the uterus or ovaries just as easily as it can from the bladder or abdomen, where it also appears. Fibroids, benign growths of collagen which can press on other organs and cause pain and heavy bleeding in some women, are the reason for about 40% of all hysterectomies. The surgery to remove these fibroids, called a myomectomy, is not even part of OBGYN accreditation. Is this best for patients? There's no question. It is not.
OBGYN surgeons author articles they share with one another claiming hysterectomy is the most cost-effective way to treat all of these conditions. That may be true if doctors don't know how to do anything else, but doesn't mean it's the most appropriate solution. More importantly, it doesn't put the patient at the center of the conversation, which is where she should be. Instead, as they say, if all you have is a hammer, everything looks like a nail. If surgeons are only trained to perform hysterectomy, that's what patients will continue to receive.
Thanks to the ability to see what's going on within various harmed groups on the internet, the patients themselves are beginning to put the pieces together. Women affected by hysterectomy and ovary removal, morcellation of uterine fibroids, Essure birth control, and pelvic mesh are beginning to find the common denominator on their own, and it's their OBGYN. Women are learning the hard way that OBGYNs are the only medical specialty that believes that increasing patient risk, up to and including death, at the time of an elective procedure is acceptable.
Removing ovaries - the results are in: early death preceded by serious illness
It is impossible to overstate the harmful impact removal of healthy ovaries has had on the health of American women. For decades, studies published in the American Congress of Obstetricians & Gynecologists' own medical journal, and elsewhere detail the fact that removing ovaries, a surgery called an oophorectomy (pronounced Oh-uh-forectomy), leads to premature death, Parkinson’s, Alzheimer’s, dementia, cognitive impairment, memory impairment, osteoporosis/fracture, cardiovascular disease, stroke, arteriosclerosis, sexual dysfunction, lung cancer, type II diabetes and metabolic syndrome, depression, and glaucoma - not just in a handful of studies, but hundreds of studies. Rather than bringing an end to the practice, it's remained in the hundreds of thousands of women per year, and the studies simply continue.
Though the result of the surgery is often called "early menopause" or "surgical menopause", the health of a woman who goes through natural menopause is not comparable to a woman with no ovaries. In fact, removal of the healthy ovaries of women aged 45 and under has been proven to result in a staggering 67% decrease in likelihood to live to age 80. Most women and their physicians never make the connection when serious illness occurs as a direct result of surgery because those illnesses can take up to 15 years after surgery to fully develop.
More than 15 million women in the U.S. are in this situation right now, but they, their primary care doctors, and their families are entirely unaware that it was a surgery suggested by their OBGYN that brought on so many serious health issues.
"Women are just beginning to understand this issue, and they're shocked and angry," says the director of overy.org, who has brought this issue to Congress to review. "Women feel betrayed, knowing that these doctors whom they'd trusted have been studying and documenting this harm for decades, but not changing their behavior. This has been a real wake up call for America's women, who have been lied to and treated as profit centers."
This isn't new information
The risks associated with oophorectomy, removal of the ovaries, has been known to OBGYNs for at least 100 years, but, rather than only performing this surgery when absolutely necessary, the surgery is done in women thousands of times a day.
Consider this quotation from a gynecologist in 1912,
"The ovary is not an organ with the single role of reproduction, but is an essential factor in the maintenance of the equilibrium which exists between the so‐called ductless glands or endo‐secretory organs. Researches into ovarian function now tend to show that the removal of ovaries for slight pathological affections, or for the alleviation of menstrual derangements, is against the best ultimate interests of the patient, and that total extirpation of the ovaries should not be practised unless these organs are the seat of some severe pathological lesion."
Translation: Women need their ovaries for more than reproduction, so, unless they're cancerous, do not remove them.
Not just before menopause, but after as well, the ovaries are endocrine glands that women for their entire lives. No question. End of story. Saying that a woman without ovaries is healthy is like saying that a woman who has no thyroid gland is in the same condition of health as a woman with one. It's not possible.
Ovaries as part of the endocrine system
Though their exocrine (in the ovaries' case, egg-producing) function ends at menopause, the ovaries most certainly do not stop working at menopause, contrary to what the ACOG tells women in their 2011 Health brochure (brochure page 33, PDF page 37). Ovaries are as crucial as any other part of this system.
Rather than ceasing to function, the ovaries make an increasing mix of hormones after menopause that result in more testosterone. Testosterone plays its known role in libido, but it also plays important roles in bone density, lack of fat, muscle mass, and a healthy energy level and sense of well-being - all key to better health during aging. The ovaries also make a very important cytokine protein called activin that is responsible for things like inflammation regulation (implied in cancer), wound healing, neuro-regeneration, auto-immune disease, arthritis/fibromyalgia, and lung alveoli reproduction.
Without the ovaries in a woman's body, she is missing one of the few places that converts cholesterol to hormones. No ovaries? More unprocessed cholesterol in the body.
So, what does this all mean for the body? An example: High cholesterol, dysregulated dopamine which comes from the adrenal glands (which are tied to the ovaries, or gonads, in the interrelation of their adrenal and gonadal endocrine axes), and inflammation which is tied to ovarian activin, are known to be present in people with Parkinson's and lewy body dementia (the kind Robin Williams was diagnosed with) and Alzheimer's.
This is just one set of effects that result from disrupting this delicate system. Women also lose strength and age more quickly. Before menopause, the ovaries convert most of the cholesterol that comes their way to estradiol, one form of estrogen. After menopause, they convert it to an increasing amount of testosterone, with less converted to estrogen, because testosterone plays a more important role in an aging body: increasing muscle mass, decreasing fat, and contributing to healthy bones. It also translates to a better overall sense of confidence and well-being.
For this reason, simply adding back in estrogen medication from the outside is far from sufficient.
This chart may appear to be a chemistry lesson, but in reality it simply says that cholesterol is the building block that the body uses to convert into various hormones.
How often are healthy ovaries removed
In terms of the most common reason cited for a hysterectomy, fibroids, the women are often not told that fibroids generally go away on their own at about age 50, at menopause, or that they can be removed through myomectomy allowing the uterus and the rest of a woman's body parts to remain behind. If they inquire about myomectomy, patients are told that it rarely works, but, according to Dr. William Parker, the head of gynecological surgery at UCLA, this is not true.
Removal of the ovaries is a separate surgery called an oophorectomy. However, OBGYNs have been removing ovaries at the same time as a hysterectomy 55% of the time since the 1980s when it rose from 25% of the time, where it had been in the 1960s. Of the 765,000 elective hysterectomies each year, at least 420,000 women are also convinced to remove their healthy ovaries.
Contrary to popular belief, removing ovaries has nothing to do with a hysterectomy or uterine fibroids, which are the most common reason doctors perform a hysterectomy. A hysterectomy involves removal of the uterus and possibly the cervix, but never the ovaries.
At least another 15% of the women, despite opting to retain their ovaries, lose ovarian function due to blood loss because of the interconnected nature of their arteries. That's another 52,000 women a year whose healthy ovarian function is lost.
Cysts and lesions of the ovaries are common and almost always benign
OBGYNs also remove healthy ovaries routinely during surgery for benign ovarian cysts, as many as 300,000 times per year. Patients are often told that their lesions or cysts are complex or unusual as a justification for surgery. Physicians scare patients by talking about ovarian cysts and lesions as though they are abnormal. The fact is that lesions and cysts on the ovaries are very common because ovaries release an egg every other month and a bubble often forms where the egg was released, or a lesion forms where the release took place. Even after menopause, at the age when ovarian cancer is more likely to occur, 18% of women develop ovarian cysts, 60-70% of these cysts go away on their own. Simple cysts are more common, and are never associated with ovarian cancer. The risk of cancer within women who only have a cyst in one location is also extremely low. Further, it's proven that even women with a family history of ovarian cancer don't have complex cysts more often. In all women, the guidance is not to perform surgery on cysts without suspect borders that are less than 7cm, and first to monitor blood levels of CA-125 and the cyst(s) for increase in size using ultrasound.
In a 1998 study of women aged 50 or older, the age at which there is increased risk of ovarian cancer, only 1/10 of 1% developed ovarian cancer out of the original 7,705 women in the study group. Of the women who had cysts, only 1.7% of all women with cysts had cancer. Of the women who had complex cysts, only 3.6% of complex cysts had cancer. In other words, most ovarian cysts and lesions, even in women who are post-menopausal, are not cancer. In almost all cases, a cystectomy rather than oophorectomy would be the appropriate, conservative treatment.
What about BRCA 1 and 2 genetic mutations & Lynch Syndrome?
10-15% of the 22,000 ovarian cancer cases each year occur in women with a known genetic predisposition that can be diagnosed through genetic testing. This is the case with the BRCA 1 or 2 germline mutations and women with Lynch Syndrome. Only 2% of the population has a family history consistent with an increased risk of ovarian or breast cancer.
The rest of the time, there is little way to tell whether women are at increased risk ovarian cancer apart from lineage, family history, and use of birth control. However, the cancer is extremely rare. Of the 160 million women in the U.S., fewer than 22,000 develop ovarian cancer each year - that's 1/100 of 1% of women. Without minimizing the impact that the disease has on those affected and their families, the fact remains that, as a disease, it's a very rare form of cancer.
The medical community and patients learn more about what removing the ovaries does not accomplish every day. For example, new studies indicate that removing ovaries is not having an impact on the BRCA1/2 breast cancer mortality rate. Physicians also believe that most cancer (epithelial cancer) that had been thought to start in the ovaries actually start in the fallopian tubes. This means that removing the fallopian tubes in women who are at risk may be the right surgery for women looking to decrease risk. A large study in British Columbia is currently evaluating this approach.
Whether it's the lack of a link to breast cancer or the idea that the fallopian tubes are the place to look for the start of most ovarian cancers, each year we learn more reasons not to remove ovaries. It is unfortunate, then, that Angelina Jolie's announcement about her ovary removal is likely to have the same effect on this already-too common surgery that it did on mastectomies. But where the result of a mastectomy is personal and cosmetic, the effect of removing ovaries increases the risk of death and disease in women. That makes the stakes for Jolie's second surgical announcement, which was published in the New York Times in March 2015 and publicized again in a Tom Brokaw interview on the TODAY show in November 2015, different and much higher. The announcement was applauded by people who don't understand the role of the ovaries or the call to over-treatment that that sort of announcement represents.
Besides popularizing the surgery, Jolie's New York Times op-ed was inaccurate about a few crucial points. One was that she was no longer at risk of dying from ovarian cancer. The unfortunate truth is that her ovarian cancer risk was reduced about 80%, but is not gone entirely, because the cancer may have migrated before her ovaries and fallopian tubes were removed. The other inaccuracy was the idea that she was "now in menopause," which makes it sound as though the largest impact of her decision was to move up the date of something inevitable, when in fact having no ovaries is nothing like menopause in its implications and health issues, and represents harm, and no benefit, for 98% of women.
Scientific American shares the concern that, though she may have had good intentions, her announcements and "celebrity effect" will do harm. In March 2015, they responded to her New York Times op-ed with an article explaining that the BRCA 1 and 2 genetic mutations (Jolie has BRCA 1) are rare, and though they did not seem to be aware of the full story of the ovaries past menopause, they were right in letting the public know that the surgery is not right for the vast majority of women.
Angelina Jolie went on to say that she was happy to be in menopause in November 2015. Her doctor should have told her that she is not in menopause. It is unfortunate that she's chosen to anoint herself a spokesperson when she doesn't really understand what she's talking about. Her ovarian cancer risk was reduced, not eliminated, and she is not in menopause. She's only 8 months out since surgery, so if she discovers that she has type II diabetes, early dementia, etc. in a year or two, it is unlikely that she will be so thrilled, though also unlikely that she will understand the connection. In the interim, it would be helpful to women if Jolie would not act as a spokesperson for a surgery that is so harmful. Her announcements make the work of re-educating the public about what menopause is and isn't even more of an uphill battle.
Not based on evidence
So, why are more than 750,000 women's healthy ovaries removed each year? There is no medical reason.
As early as the 1950s, the question was being asked within the medical community, "We know removing ovaries is harmful. We claim we're doing it to prevent cancer; are we sure it's working?" That was an early call for evidence-based practice which went, and continues to go, unanswered.
Ovarian cancer is rare, but the OBGYN proponents of ovary removal claim that it's also hard to detect until later stages, and as a result, more often fatal than other forms of cancer, so, let's look at the SEER stats again.
Pancreatic cancer affects 56% more people than ovarian cancer each year. It is at least as hard to diagnose, and far more likely to be fatal, with only 7% surviving past 5 years as opposed to 45% of women with ovarian cancer.
The pancreas provides a meaningful comparison to the ovaries for another reason. Like the ovaries, it is both an exocrine and an endocrine gland; the exocrine portion produces digestive enzymes, and the endocrine portion produces hormones including insulin. A healthy pancreas could be preventatively removed and the patient could live on a combination of external insulin and digestive enzymes, yet despite the fact that it afflicts more people and is far more deadly, no surgeon would recommend the preventative, or "prophylactic," removal of a healthy pancreas, or any other body part.
Even in the case of prophylactic mastectomies, these are done 80% of the time when cancer has been found in the other breast and only in women at proven risk for breast cancer. It's not done in any woman who happens to be on the operating table, but OBGYNs are not assessing their patients for ovarian cancer risk. They're just removing healthy ovaries in the hundreds of thousands.
In removing healthy ovaries to "prevent ovarian cancer," the ACOG is talking out of both sides of its mouth. When asked to assemble a list of procedures they would recommend their members avoid, the only item that made the list that had to do with gynecology versus obstetrics was this: Don't screen women at average risk (i.e., 98.7% of all women) for ovarian cancer. They don't just screen for it once every three years, as with a pap smear for cervical cancer, they never screen for it. But they do remove healthy ovaries in these same women. How can a cancer be so important that it is worth removing an entire part of the endocrine system, or any healthy body part, but not worth an annual test?
In terms of practicing evidence-based medicine, has it worked? Has it saved women?
Removing healthy body parts to prevent cancer, as a strategy, does not work and it's no surprise. 98.7% of all women have no risk of ovarian cancer.
Removing the healthy ovaries of over 2,000 women a day is effectively comparable to using a boulder to crush an ant both in its overtreatment and its unreliability. If this strategy worked, removing the healthy ovaries of hundreds of thousands of women a year should have had an impact on the ovarian cancer mortality rate. Instead, it has not had any impact on ovarian cancer mortality at all. It simply doesn't work as a strategy.
It only has one effect: it takes apart women's healthy metabolic and immune systems. If OBGYNs practiced evidence-based medicine, as they claim to, this is surely adequate evidence.
When evidence-based medicine informs decisions
Tonsillectomy, a far less serious surgery with a mortality rate 1/15 the rate of hysterectomy, could serve as an example, to OBGYNs and the ACOG, of putting evidence-based medicine into practice. Quoting a Boston University 2015 News Service article by Judith Lavelle:
"In this way, the procedure’s history fits into a much larger revolution in medical practice in the United States. Tonsillectomies performed on the basis of infection didn’t start fading out until physicians began to embrace 'evidence-based medicine'—the idea of using the results of peer-reviewed research to support medical decisions at the patient level. By the mid-1980s, physicians used clinical data to set national guidelines and standardize the indication for a tonsillectomy: three cases of tonsillitis per year for three years, five infections per year for two years, or seven infections in a single year. It didn’t take long for the procedure to decline. By 1986, surgeons removed tonsils only 281,000 times, less than a quarter of the number in the mid-1960s.
But that doesn’t mean that, even now, tonsillectomies have shed their reputation among parents. 'I’ve definitely had patients’ families where parents have had their tonsils out,' says Dr. Jessica Levi, a pediatric surgeon at Boston Medical Center. 'They’ll come with their child and want their child’s tonsils out, but they don’t have a great indication for it.'"
When patients who don't qualify for surgery ask for it anyway, the doctors say no. They don't use words like "cancer" when none is present, they don't find attractive ways to dress up the surgery by calling it "minimally-invasive", and they don't continue to practice it in the face of lack of evidence, regardless of "patient choice". They are the doctors and they know that their obligation is to use their expertise to serve their patients, and that sometimes that means saying no to unsupported surgical intervention.
No surgeon in any other case ever removes healthy body parts when the patient hasn't proven to have either existing or a very high risk of that type of cancer. Never. Yet this is what is being done in 2,000 U.S. women a day with healthy endocrine glands without which the women die prematurely. It is unspeakably harmful and not medical in its approach.
The ACOG is turning a blind eye
When Dr. Christine Larson believed that the ACOG and its members didn't know the harm they were doing and offered her research to them for publication in their medical journal, they flatly refused.
"Schmitt recommended that an article summarizing the findings be submitted to “The Green Journal” (Obstetrics and Gynecology), ACOG’s official publication, which would provide the broadest dissemination across the OBGYN specialty. That article, submitted in 2009, was declined for publication with no opportunity for revision."
Instead, her research was accepted and published in Current Oncology and Oncology News.
"Given that the ACOG practice guidelines were found to play a significant role in the persistence of oophorectomy in women at low risk, a second objective with the research was to work toward revised ACOG practice guidelines, because those guidelines serve as the medical–legal floor for the specialists."
She also found that many of the OBGYNs were smug, suggesting that it was just a poor choice on the part of patients, rather than the surgeons' suggestions, that was driving this harmful surgery:
"Thomas Martin, MD, chair of OBGYN, with twenty-eight years of clinical practice, to Dr. Larson, 'It's their gonads. No man asks to have his testicles removed.'"
Morcellation and bad math
Why do we need congressional intervention? Why couldn't we trust the ACOG and its members to regulate themselves?
The recent case of the morcellator, which went before the FDA in 2014, tells us all we need to know about the ACOG's attitude toward increasing patient risk.
A morcellator is a stick blender-like medical device used to chop up the uterus and fit it through the holes made in the woman's abdomen during robotic surgery. It wasn't until this was done to an anesthesiologist, Amy Reed, whose husband, Hooman Noorchashm, is also a doctor, that anyone in medicine or the government listened to patients' concerns about what was happening when hidden or misdiagnosed cancer that was thought to be fibroids was cut up using a morcellator.
Despite the fact that her surgeon followed protocol and performed all of the tests typically done to eliminate concerns about cancer, beforehand, Dr. Reed was told after her surgery was done that hidden cancer had been present and that it had been taken from a stage 1 tumor to stage 4 cancer when the morcellator spread it through her system.
For the previous 20 years, women had been told that a daVinci robotic surgery was the best way for them to spend little time in the hospital and to recover quickly with minimal scarring. Patients were not told that, for 20 years, doctors had seen but not reported the fact that some women's fibroids turned out to have been sarcoma, or that that cancer had been spread by the morcellator.
When confronted, the ACOG told the FDA that they had studied the risk, and found that it was very low: 1 in 10,000. When the doctors were asked how many surgeries were being performed this way each year, the answer was, "As many as 320,000." Even prior to a re-evaluation of their math, the ACOG and its members were, to their knowledge, making at least 32 women a year incurably ill.
Things got worse when the FDA looked at the studies the ACOG had been using, and determined that the ACOG's math was wrong. Really wrong.
The ACOG had been using all women in the country as the base group, or "denominator", rather than just the women who had surgery for fibroids. When the ACOG's math was corrected, the FDA reported that the risk was very different. 1 woman in 352 who had presented for surgery for fibroids instead had sarcoma. The ACOG was told that it was making hundreds of women incurably ill. Their response? They still didn't intend to change their behavior.
Let's say the risk of cancer is 1 in 10
The husband and wife physicians expected the response from the doctors to be immediate and concerned. They imagined they would set the morcellator aside, and go back to performing surgery in the safer ways that had been available to them for hundreds of years. Instead, huge numbers of OBGYNs rushed to morcellation's defense, saying that the benefit to most women made it worth the risk to the others. This response blindsided Drs. Reed and Noorchashm because this is not the way surgeons are trained to think. If a certain practice is making things worse for patients, doctors set it aside quickly - a concept upon which the American public and their trust in their doctors depends. In defending morcellation as a common practice, the ACOG was actually reversing its position from just a year before, when they said that robotic surgery was really only best-suited for unusual cases, not everyday surgery.
The ACOG must have realized that the benefit is, of course, not to the women, but to the doctors whose time was spent training to use the machines and to the hospitals that had invested about $1 million per machine. The money's pretty good. More women are willing to agree to undergo a surgery when it is described as "minimally invasive", and that's just what happened in the past 10 years. The number of hysterectomies has risen by about 25%. Doctors make more money, the makers of the robot make more money, and the hospitals that have invested in the robots recoup on their investment.
Even websites like HysterSisters, a sort of online hysterectomy sorority that has some of the earmarks of an 8-year old girls' birthday party (but, you know, for surgery) leapt to its defense. HysterSisters has long been a physician favorite, some even paying to be listed in its directory. There, surgery and all its attendant risks is coated in pink sugar: the hospital is referred to as "the castle", and the women having surgery are "princesses" who receive tiaras one year after their surgery.
Why was HysterSisters concerned that morcellation continue? Intuitive surgical is their largest advertiser. During Drs. Reed and Noorchashm's fight to raise awareness about the morcellation risk, HysterSisters' CEO wrote an op-ed for the website empowHER, saying that the concern was overblown and women must not give up on morcellation. She wrote this without disclosing her financial conflict, leaving women to believe that she was just looking out for their best interests.
Rather than being praised as heroes within the medical community for uncovering how great the risk to women's health was, Drs. Reed and Noorchashm found themselves in a kind of doctor/patient purgatory where they, as physicians, experienced the backlash that so often occurs when patients question their doctors.
The Reed/Noorchashm family has been brave by anyone's definition. Through what is now three rounds of treatment, during chemo, the care of their 6 young children, and continued schedules as doctors, Dr. Reed and her husband, Dr. Noorchashm, have been unrelentingly vocal in raising awareness about the surgical choice the ACOG has made in continuing to use the device, and the FDA has made by leaving it on the market. Brave by anyone's definition but the ACOG, who consider him something of a pain. In one article, the husband, Dr. Noorchashm's interaction with the ACOG was described:
"...it ruins business and halts the steady flow of dollars to device manufacturers, hospitals, and doctors. Dr. Noorchashm’s attempts to point out, in a reasoned fashion, where and how morcellation increases patient risks have been aggressively met with insults, push back, and even the suggestion that he is acting irrationally due to grief over his wife’s condition, and that it would be much wiser for him to remain quiet to protect his career.
'As we have repeatedly said, nothing is going to create any 'peace' in this man.' — Gerald F. Joseph, MD, Vice President for Practice Activities at the American College of Obstetricians and Gynecologists (ACOG), in response to Dr. Noorchashm’s request for ACOG support in changing morcellation practices."
Dr. Amy Reed, facing, embraces a supporter after testifying at an FDA hearing on power morcellation in July. Photo: Jennifer Levitz/The Wall Street Journal
OBGYNs' reaction in defense of morcellation was often so callous that one of the doctors, Dr. Keith Isaacson of Newton-Wellesley hospital, who had been present for the cancer patients' testimony at the FDA in June 2014 then went to an ACOG annual meeting in May 2015 and said,
“I don’t care what number you pick. Let’s say the risk of cancer is 1 in 10 instead of 1 in 8,000, I still think the patient should be involved in the decision-making process after a discussion of the benefits vs. the risks.”
As with ovary removal, the ACOG's response was: 1) not to alter practice, 2) to continue to harm patients, 3) to study that harm. They concluded that they were going to keep a database, or "registry", (see page 2) of women whose cancer was upstaged, as they continued to perform the procedure with the morcellator.
This is where the lack of regulation comes into play. The ACOG isn't interested in changing, and the government has given them a wide berth. No one is willing to tell them that making women sicker...that harming them is, in fact, illegal. Keeping a list of names of women made incurably ill has, as Dr. Noorchashm wrote in an op-ed in the Philadelphia Inquirer, a Dr. Mengele-like quality to it.
Manipulating informed consent
To each decision OBGYNs have made that has increased risk for their patients, up to and including premature death, the ACOG provides the same answer: they are offering the patient this risk in order to increase her range of choices, and it's not the government's business to regulate their surgical decisions or check their math.
According to a recent Wall Street Journal article, "It is none of their business," said Jeffrey Thurston, 58, a Dallas gynecologist who has practiced for three decades and said he performs 80 percent of his hysterectomies with a morcellator."
Is it arrogance, then, that stands in the way of being receptive to information that they are harming patients? Is it payments from device and drug manufacturers? Or is it the fact that there have been more men named Richard serving as past presidents of the ACOG than female presidents in total? Are these men out of touch with the effects of decisions which could never possibly affect them, personally? Why is a Russian roulette model being introduced in medicine by these practitioners? Why is the patient instead being handed a loaded gun?
Informed consent is meaningless in the hands of a biased provider. Though the FDA, after the June 2014 morcellation hearings, put what they refer to as "black box warnings" on the morcellator, this hasn't deterred many doctors.
"Dr. Thurston asks patients undergoing power morcellation to sign an informed-consent document that describes the cancer-spreading risk and puts the risk of an undetected sarcoma at between 1 in 300 and 1 in 1,000.
But 'we tell them verbally that we don't think those numbers are correct,' he said. He also tells patients there is no good data to show morcellation worsens sarcoma." (source: The Wall Street Journal/Jennifer Levitz and Jon Kamp)
Though women are more than capable of making decisions about their own bodies, this right is being twisted and used against them, taking advantage of what they don't know about medicine and the trust they place in their doctors. This model is analogous to that of a parent. The doctor introduces bias simply by offering the choice, to begin with. The presumption on the patient's part is that their doctor would not offer a choice that introduced significantly more risk than benefit. It's like offering a child the choice of chocolate, vanilla, or being thrown from a speeding car; not all choices are created equal, and obviously some should simply not be offered.
The fact that the majority of this country's OBGYNs don't recognize this limitation to the value of choice forms the foundation of the picture of OBGYNs' surgical attitude that "prophylactic oophorectomy", or preventative ovary removal, completes.
These surgeries are highly discriminatory
Under Section 1557 of the Affordable Care Act, women should be protected from disparate treatment in hospitals, the majority of which receive federal funding.
In what way can this surgery be compared to other surgeries in terms of whether they are performed comparably on men as they are in the case of women?
Ovaries and testes are both gonads. Over 2,000 U.S. women's healthy ovaries are removed every single day. The only rationale given by surgeons has been that this is done to prevent future cancer.
Testosterone is needed for prostate cancer to grow. Prostate cancer kills twice as many men each year as ovarian cancer kills women. Removing testes, the ovaries' equivalent in men, is the "gold standard" in addressing prostate cancer. If hundreds of thousands of ovary removals are occurring each year, there must be twice as many preventative testes removal surgeries, right? So, how many preventative testes removals take place each day? Each year? None. It's never done.
Though the prostate cancer mortality rate is double, the surgery, which is the equivalent surgery in men, is never performed in men without diagnosed cancer unless they have tried hormone suppressant treatment and it has failed first. It is never done "just in case," and it is never done as a first line of defense. In other words, there is a double-standard despite the fact that twice as many men receive that diagnosis, doubling the rationale.
Where people are outraged when clitoridectomies are performed in other cultures, this surgery affecting not just sexual function but life expectancy occurs in the U.S. in the thousands every single day.
It is a procedure with all risk and no benefit for the vast majority of women. The data is in. It has been studied ad nauseum to an extent that could be described as prohibited by the Nuremberg Code. It is that unethical.
From a legal perspective, because this harmful approach is only taken with one class of people, it is also discriminatory.
These surgeries are also highly profitable
No group is currently tracking ovary removals today - not the CDC or the AHRQ.
Within hospitals' billing code system, ovary removal is ignored and is lumped in with hysterectomy as though it were related or inconsequential. Unsurprisingly, the more that is removed, the more the doctor bills. It is important to note that this system of lumping ovary removal in with hysterectomy within billing makes it very difficult for hospitals to track and report how many times ovaries are removed alongside a uterus, even though the surgeries are separate, from a surgical perspective. Fibroids and heavy bleeding have nothing to do with removing the ovaries and ovarian cysts have nothing to do with removing the uterus.
(Note the estimated charges in the chart above are only the doctor's fee, not the total hospital costs.)
To better understand it as an industry, we have to look at the money that comes in from elective hysterectomies every year.
764,000 elective hysterectomies are performed in the U.S. every year, and each costs a mean of $33,180, according to the AHRQ. That's $25,349,520,000 a year (yes, 25 billion plus).
Setting the risks of oophorectomy aside for a moment, can 40% of a 160 million population of US women (page 52) truly require major surgery by ages 45 to 54? Why is no one asking this question?
This transcript excerpt from NPR's This American Life, Episode 391: More Is Less, Originally aired 10.09.2009 provides a plausible answer (note, as mentioned above, in the full episode, Alix Spiegel is incorrect when she refers to the removal of ovaries as part of a "total hysterectomy"):
Alix Spiegel: Doctors are uncomfortable acknowledging the role of money, but every doctor I talked to admitted, it affects medical decision-making. Including Gordon Smith, head of the Maine Medical Association.
Gordon Smith: Of course it does. That's just common sense. That's human nature. The payment system is an important influence.
Alix Spiegel: You see, the majority of doctors in this country are not on salary, but are paid for each thing they do: a la carte. That's what they mean when they say, fee for service. A phrase you've probably heard a lot. And the way fee for service affects doctor behavior is clear.
Gordon Smith: If you pay people more the more things they do, they're going to do more things.
So, while state and federal government regulates everything from blogger licensing to a license to go out of business, the Senate Committee on HELP (or "Health, Education, Labor & Pensions") and the House Subcommittee on Health turn a blind eye to what they see so clearly in the case of banks and other multi-billion dollar industries: that self-regulation when confronted with the ability to turn the dial up on mountains of money leads to intentional or unintentional corruption of decision-making. In giving medicine a free pass, the U.S. government has failed to protect Americans at their most vulnerable, when they're confronted with doctor recommendations ranging from quality of life to life or death.
The role the government has to play in medicine is expressed in the 1988 'Government Regulation of Business: The Moral Arguments' by Tibor R. Machan:
"The second type of market failure, identified by John Kenneth Galbraith in The Affluent Society, is that markets misjudge what is important. To wit, markets often don’t respond to real needs—for medical care, libraries, safety measures at work, health provisions, fairness in employment and commerce, and so on. Therefore, governments should remedy market failures with regulatory measures. Such measures include zoning ordinances, architectural standards, safety standards, health codes, minimum wage laws, and the whole array of regulations which have as their expressed aim the improvement of society."
What can be done to address these issues
The answer will not come from interacting with the ACOG. They received the letter and research contained on this site in July 2015, and responded this October 2015, cc'ing Senator Patty Murray (D-Washington state), who is the ranking Democrat on the Senate's House Committee on HELP.
In their response, written by Christopher M. Zahn, their Vice President for Practice, they provided no evidence to support the surgeries, yet they claimed that their decisions were rooted in evidence-based medicine. In a bizarre and unexpected departure from their persistent claim that the surgery had been done to prevent cancer, the ACOG offered that most women are having the surgery not because of a risk of cancer ("prophylactic oophorectomies"), but because the physicians are leaving it up to the patient, leaving no medical rationale for the surgery at all.
Christopher M. Zahn, ACOG Vice President for Practice since May 2015
This response, with its complete absence of data does nothing to provide a counterpoint to the mountains of data accumulated here. Though its author, Dr. Zahn, invokes the words "evidence-based medicine", saying it informs the ACOG's decision-making, the proof is in the response. Apart from their own opinion that what they're doing is fine, they don't cite one study or other kind of evidence to support the continued practice of these surgeries, nor anything to refute the claims that it is tremendously harmful in a number of ways. Though Mr. Zahn falls back on the old ACOG trope of patient choice, this is, as it was when it was used in the case of morcellation, wholly inapplicable and cynical. In its statement that the ACOG's members are leaving the decision to remove healthy ovaries to the patient, the ACOG has fallen outside of the bounds of sound medical judgment. Patients aren't walking in to doctors' offices asking to remove healthy ovaries any more than they are asking to remove a healthy pancreas.
The fact is that women are removing their ovaries because doctors are telling them that it is beneficial. Surgeons offer the idea that ovarian cancer risk exists for them, and the patients believe they are undertaking a surgery that will prolong, not shorten, their lives. To suggest otherwise would be to question the sanity of the patients. If the patients knew of the role of the ovaries in their bodies, the increased risks associated with removal, and the extremely low risk of cancer, they would not undertake this, but the physicians also ignore in that response their responsibility to guide patients away from a choice involving harmful, if not lethal, over-treatment.
The government's failure to regulate this multi-billion dollar industry has left room for its judgment to spiral out of control, resulting in serious health crises where women at an age where health issues are not considered or addressed have become the subject of experiments, and a profit center for this specialty. For this reason, Congress has a responsibility to ensure that a hearing take place. The fact that the group responsible are doctors is more reason, not less, to demand accountability. There's too much evidence to the contrary to continue to presume the doctors' actions are benign. Healthy women have been made ill with full knowledge and intent, not human error, and, last time we checked, that was a crime.
Personal stories of women affected
Read the personal stories of women who only know about the tip of the iceberg in terms of the impact of ovary removal on their health.
Action within the government to-date
At this point, the government is well-aware of the oophorectomy issue and is letting the American people down. All of the members listed below were sent the July 2015 letter, and were called and emailed multiple times.
Senator Mark Warner responded to the research via email on August 6 by email to say, "Thank you for contacting me regarding issues with the professional judgment of OB/GYN doctors. I've taken the liberty of contacting the Food and Drug Administration on your behalf asking that they review your concerns and get back to me with a detailed and appropriate response. As soon as I receive a reply, I will again be in touch with you. To sign up for my newsletter please visit www.warner.senate.gov. Sincerely, MARK R. WARNER United States Senator"
On September 4, 2015, Charlie Arnowitz from his office responded to an email, reporting that the FDA should be responding to the concerns the following week. There has been no FDA response via Senator Warner, so we reached out to Peter Lurie, M.D., M.P.H., the FDA's Associate Commissioner for Public Health Strategy and Analysis, to ask whether the FDA was not an inappropriate agency to be evaluating the issue, since it addresses surgeries versus pharmaceuticals or devices, which are within the FDA's purview. Dr. Lurie agreed, saying, "This issue is not really for FDA."
On August 27, this organization met with Melanie Rainer and Carly Rush from Senator Patty Murray's office, and never heard back from that office. It's possible, however, that that meeting is the reason Senator Murray was cc'd on the response from the ACOG on October 1, 2015.
Dr. Lurie from the FDA had suggested that Wade Ackerman, from Senator Murray's office, was the right person to speak to regarding health policy. Mr. Ackerman has not responded to a September 30, 2015 email requesting a meeting.
Virginia Governor Terry McAuliffe sent the issue to the Virginia health department for a response on August 28, but they have yet to provide one.
On September 1, Dominic Bonaiuto of Virginia Congressman Gerry Connolly's office wrote to say that the issue had been sent to Dr. Nancy Lee, head of the Women's Health group within the Department of Health & Human Services. To our knowledge, Dr. Lee has not responded.
On September 11, 2015, an ovary removal fact sheet was sent to Caroline Robinson in Senator Tim Kaine's office after several calls and emails to him and his staff. She had said she would look into the issue but has not provided a response from Senator Kaine's office.
No response has come from any other member of the Senate Committee on HELP (Health, Education, Labor & Pensions) - not from Senator Al Franken, Senator Elizabeth Warren, or Senator Bernie Sanders (though Senator Sanders could reasonably be given a pass with his current schedule).
Senator Lamar Alexander did respond via email. However, his response was, oddly, about the fact that he was not interested in views on Planned Parenthood.
Because millions of women are currently affected by the OBGYNs' surgical decision-making, these senators can all count affected women within their constituent base. Because this has been raised by a group within Virginia, these senators on the Health Committee may think that they are leaving Virginia politics to Virginia senators, but this is not correct.
Demand for a congressional hearing
After the latest response from the ACOG, it is even more incumbent upon Congress to set the date for a Congressional hearing about the issue of removal of healthy ovaries for decades in the face of overwhelming evidence of its harm and lack of benefit. This is not a question of routine regulation of medicine; this is a question of harm for profit. The practice is most definitely outside of the normal realm of medicine, and represents deceptive, deadly, criminal activity.
Because there is no possibility that any health advisory group can come back with the opinion that disassembling healthy endocrine systems is ever ok, the Senate must stop wasting time reaching out to various agencies, which are hand-in-hand daily with the physicians. The request has been sent to a dusty filing cabinet rather than forming the centerpiece of the discussion that must be had. In a situation where physicians have political action committees and money, the senators must create the checks and balances needed by giving these studies and this research the power and voice to level the field against congressional influence.
The Department of Health & Human Services currently accepts the ACOG's recommendations on faith and supports them by embedding them in their site. If this practice continues, the women affected may have a complaint against not just the ACOG, but against the government. This surgery represents a clear violation of American women's human rights. Allowing physicians to profit from making healthy women ill is not permissible. No second home, no new boat, no family vacation is worth the health of a doctor's patients.
A footnote about the future of the OBGYN specialty
Whether it comes sooner or later, the most long-term casualty of the physicians' poor judgment is likely the end of the OBGYN specialty as we know it today. Though the obstetrics aspect of the practice will likely continue much as it is today, it will likely fall under greater scrutiny because the physicians have allowed the c-section rate to rise an astonishing 60% between 1996 and 2009 to a level of 33% of all births, a full 18% above the World Health Organization's healthy upper limit cap of 15%. American OBGYNs know that babies born vaginally are healthier because their exposure to different bacteria as they are born is crucial to their healthy development. Without this exposure, the babies are more likely to develop immune diseases such as asthma, allergies, type 1 diabetes, Crohn's disease, celiac disease, and multiple sclerosis. Yet, the American rate of c-section has represented a full 1/3 of all births for the last decade.
A responsible agency will need to examine the cause for this high rate. Whether it is a question of physician convenience or the fact that c-section pays out at $50,000 compared with the rate of $30,000 for a vaginal birth, it is not a function of women requesting surgery that is driving this rate. The fact is, today's c-section rate is harmful for babies and mothers and adds to the U.S.' poor showing when it comes to infant mortality.
The likely casualty, though, is the other side of the specialty: gynecology.
"The American College of Physicians, which published their guidelines on Monday, and the American College of Obstetricians and Gynecologists agree that an annual pelvic exam in asymptomatic and non-pregnant adult women does more harm than good. For one, there is no evidence showing that screening pelvic examinations reduce rates of illness and death in asymptomatic adult women."
The fact is that even analysts within the specialty itself cannot find a reason for patients to come in for an annual exam. The ACOG assigned a task force to provide new guidance for what they refer to as the "well woman visit", or, the annual exam. In the end, because the pap smear (checking the cervix for cancer) has been reduced from a once every year exam to a once every three years exam since the Affordable Care Act's guidance was put in place, there is no reason left to see a gynecologist, and in fact there are plenty of reasons not to, all related to over-treatment.
The task force concluded that there were two reasons left to do an exam. One was to look at the vulva for lesions, the other was to ask questions about domestic violence. That's it. And the guidance tool they came out with was considered so unusable and complex that a doctor wrote a rebuttal saying that the AHRQ's Electronic Preventive Services Selector already had a similar tool that did a much better job.
Vulvar cancer is an extremely rare form of cancer, one that could not possibly justify the existence of an entire medical area of specialty or an annual visit. With respect to domestic violence, there are certainly other groups better qualified and solutions better suited than waiting for an annual OBGYN visit to address that concern, none of whom increase a woman's likelihood of ending up on an operating table.
In the end, the task force appears only to have accomplished one thing: They made it clear that a general practitioner is a much better choice for women who want to avoid unnecessary surgery. Because a woman's regular doctor doesn't stand to profit if he or she finds something during an exam, that exam is more likely to yield unbiased results. So, if women are willing to check themselves, or can find a regular internist who can occasionally check for vulvar lesions, which are incredibly rare, and internists are willing to write orders for mammograms (or not, as the controversy ensues), the only thing left is a pap smear every three years and questions about domestic violence - things that can be left to any qualified general practitioner.
The ovaries are tied to the ability to deal with stress, disease immunity, blood pressure, and functioning of the central nervous system. A short film about the ovaries role in the body is available here.
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