medical marketing

Mammography Screening – When an Educated Consumer Is Not the Best Customer

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The purpose of preventive mammography screening is to diagnose breast cancers that would result in death at an early stage, thereby decreasing the incidence of late stage breast cancer and overall breast cancer mortality.

A number of reviews and studies have been published over the past several years to determine the effects of mammography screening in achieving these goals. They reveal that mammography screening provides little to no benefit in terms of reducing breast cancer mortality, and yields significant risks and harm to women who receive false positive results and especially to those who are overdiagnosed and overtreated. The risk of overdiagnosis of cancers that would never have been a threat to or even discovered by women in their lifetime includes future treatment-induced cancers.

Statistical percentages such as a 20% or 30% reduction in mortality, ordinarily referenced in reports promoting mammograms, mislead women into thinking that a large number of lives are being saved. However, by looking at the actual number of lives saved by preventive screening in light of the total population screened and the actual number of women harmed by false positives and overdiagnosis we have a truer picture of the effects of mammography screening on breast cancer mortality. Real numbers show that the actual risk to women of dying from breast cancer is far less than women are led to believe while the risk of overdiagnosis, rarely mentioned, is far greater than they would expect. Studies showing a mortality reduction with mammography screening often manipulate statistics to misrepresent the perceived benefits.

The perception that mammography is of great benefit is also influenced in part by the promotion of screening as a life saver and by overdiagnosed women believing their lives were saved.

Despite evidence to the contrary, medical and charity organizations support continued mammography screening of women. Women are not made aware of the real evidence against screening. This is in part because of vested interests and in part because of consumer demand for preventive testing based on the even miniscule possibility that it may save their life. However, if women were aware that the possible harm is far more significant than any possible benefit, they would probably opt out of preventive mammography screening.

The breast cancer industry benefits from women’s lack of knowledge. It is not in their best interest to tell women the truth.

Marketing Mammography by Disregarding Data

Preventive mammography screening is supposed to save lives by detecting and treating cancers at an early stage, before they become clinically evident. This is supposed to reduce the numbers of late stage breast cancers and the overall mortality from breast cancer.

This is what every woman who goes for preventive mammography screening believes and what organizations like the American Cancer Society promote and charities such as the Susan G. Komen Foundation will have you believe with those ubiquitous pink ribbons and their “Run for the Cure”.

While you continue to wait for them to finally discover a cure, be aware of the following: despite the assertion that “mammograms save lives” the truth is that millions of women are being misled into undergoing a screening that has been shown over the years to do more harm than good in multiple ways.

If the end result was a really significant reduction in breast cancer mortality we might concede that some of those harms are worth the risk. Unfortunately, too many studies have shown that although more early stage cancers are being detected there is no reduction in the overall mortality from breast cancer and that screening significantly harms more women than it helps. The dangers of screening include many false positives with additional diagnostic testing and, more critically, a high rate of overdiagnosis — the detection of cancers that would never have been a threat to or even discovered by women in their lifetime. Overdiagnosed cancers lead to overtreatment with surgery, radiation, chemotherapy, and hormone therapy that needlessly put women at risk of future treatment-induced cancers. Preventive breast cancer mammography screening has really been a colossal failure and the wool continues to be pulled over women’s eyes.

What the Research Really Shows

Consider the following reviews and studies (published between 2011- 2015):

  • In a retrospective trend analysis on mammography screening, researchers Philippe Autier, Mathieu Boniol, Anna Gavin, and Lars J. Vatten compared 3 pairs of neighboring European countries having  similar population structure, socioeconomic circumstances, quality of healthcare services, and access to treatment where mammography screening was implemented many years apart in order to determine the effect on mortality that such screening had on early detection of breast cancer. “Our study”, they concluded, “adds further population data to the evidence of studies that have used various designs and found that mammography screening by itself has little detectable impact on mortality due to breast cancer.”
  • Drs. Archie Bleyer and H. Gilbert Welch discussed their 30 year review of United States data related to mammography screening of women 40 years of age or older. They found that while screening mammography has been associated with a doubling in the number of early stage cancers detected, it has only resulted in a decrease of 8 cases of late stage cancer per 100,000 women. This disparity is attributed to an estimated overdiagnosis (and overtreatment) in the past 30 years of 1,300,000 women or an overtreatment rate of 31% of all diagnosed breast cancers.
  • The Swiss Medical Board, an independent health technology assessment initiative, performed a comprehensive review of mammography screening, noting the controversy over the previous 10-15 years regarding mammography’s benefits. Reviewing mammography screening from the first trials 50 years ago in New York City to the most recent led to the determination that it’s possible that of 1,000 women screened, one death attributable to breast cancer might be prevented although there was no evidence showing that overall mortality was affected. However, the prevalence of false positive tests and overdiagnosis, they concluded, causes women more harm than good. For every breast cancer prevented over a course of ten years of screening, beginning at age 50, between 490 and 670 women will have a false positive diagnosis and repeat examination; between 70 and 100 women will have an unnecessary biopsy; and between 3 and 14 women will be overdiagnosed.
  • The Nordic Cochrane Report, an independent reviewer of scientific studies, reviewed 7 eligible studies comparing women ages 39 – 74 who were and were not screened using mammography. The authors, Peter C. Gøtzsche and Karsten Juhl Jørgensen, determined that breast cancer screening reduces mortality by approximately 15% and that overdiagnosis and overtreatment is at 30%. Realistically, this means that for every 2000 women invited for screening over the course of 10 years, one woman will have avoided dying of breast cancer while 10 healthy women will have been overdiagnosed and overtreated. In addition, over 200 women will have a false positive diagnosis requiring additional screening.
  • The 25 year follow-up for the Canadian National Breast Screening Study, by Anthony B Miller, et al., which compared screened and unscreened women ages 40 – 59 for breast cancer mortality, found no reduction in mortality as a result of the screening. They determined that there was an overdiagnosis of breast cancer of 22% among women with screen detected invasive cancers. Screening 44,925 women resulted in an overdiagnosis of 106 women or, in other words, for every 424 women screened, one woman was overdiagnosed.

Statistical Shenanigans in Mammography Numbers

The article that I like most however (a touch of sarcasm here) is this one that headlines:
National screening programme has markedly reduced breast cancer mortality

Read only the headline or just the first two paragraphs and you will have confirmed that mammography screening reduces breast cancer mortality between 20 – 30% in the women who undergo testing.

Continue to the third paragraph and you will find that the study actually corroborates all the other ones listed above – that very few lives are saved by preventive mammography screening and that a far greater number of women are overdiagnosed and overtreated. It reads:

“The evaluation examined a number of sides to the national screening programme and determined among other things that the probability of being overdiagnosed by screening is five times higher than the probability of avoiding death by breast cancer. Overdiagnosis in this context means that without being screened, the women would never have noticed, been aware of or died from the disease. Under the Norwegian Breast Cancer Screening Programme, all women aged 50 to 69 are invited for mammography screening every two years. Under the programme, for every 10,000 women invited to 10 rounds of screening, roughly 377 cases of tumours or pre-malignant breast lesions will be detected. From this group, roughly 27 women will avoid death from breast cancer as a result of early diagnosis and treatment. However, roughly 142 of them will be overdiagnosed with a disease that will turn out to be harmless.”

It should also be noted that the prevalence and harms of false positive results, although not discussed in the article, are considered in the evaluation report. They are also not insignificant.

Although the other reports cited above show even more harm and fewer lives saved, we can clearly see from the intentionally misleading Norwegian report, just how inconsequential mammography screening is in reducing breast cancer mortality.

Declaring a reduced mortality rate of 20-30% due to screening without providing actual numbers is highly deceptive. The key isn’t the percentage but the actual numbers upon which those percentages are based. If we found that 5,000 of these 10,000 screened women were diagnosed with a breast cancer that would have metastasized and 25% are saved from death by early screening, then 1250 women would have been helped. However, given the actual figure of 27 women saved, a 20 – 30% reduction of mortality takes on a very different meaning.

In reality, the headlined “marked mortality reduction” figures were actually calculated based on the assumption that without screening either 135 women (20% reduction) or 90 women (30% reduction) will have been assumed to die of breast cancer. In other words, among 10,000 women not screened, from 9/10 of one percent to 1.35% of the women would likely die from breast cancer. This also means that between 63 -108 women will die of breast cancer regardless of having been screened. (It has been found that breast cancers which metastasize are quite aggressive and often become palpable within a year after screenings that yielded negative results. False negative results can also be to blame.)

The 377 women diagnosed with tumors or pre-malignant breast lesions out of the 10,000 women screened represent almost 3.8% of the screened population. The 27 treated women who avoided death by screening represent not quite 3/10 of one percent (.0027) of the 10,000 screened women. The 142 women needlessly diagnosed and treated represent 1.4% of the 10,000 women screened.

Overdiagnosis Feeds Misperception and Profits

When looking at the actual number of women involved, the 20-30% mortality reduction doesn’t sound so wonderful anymore – but then neither does the risk of breast cancer seem as scary.

Nevertheless, this estimate of breast cancer mortality with or without screening is far less than most women believe population and personal risk to be. According to the Swiss Study cited above women believe that for every thousand women screened 80 will die from breast cancer while for every thousand women not screened 160 will die from breast cancer. The real effect of screening, they found, is that for every thousand women screened 4 will die from breast cancer and for every thousand women not screened 5 will die from breast cancer.

Why the great disparity between women’s real and perceived risk of dying from breast cancer?

As expressed in the Norwegian study’s evaluation report, just the fact of the screening programs alone increase women’s perception of the risk of and mortality from breast cancer.

More importantly, however:

 “Overdiagnosis creates a powerful cycle of positive feedback for more overdiagnosis because an ever increasing proportion of the population knows someone—a friend, a family member, an acquaintance, or a celebrity—who “owes their life” to early cancer detection. Some have labeled this the popularity paradox of screening: The more overdiagnosis screening causes, the more people who feel they owe it their life and the more popular screening becomes. The problem is compounded by messages (in the media and elsewhere) about the dramatic improvements in survival statistics, which may not reflect reduced mortality, but instead be an artifact of overdiagnosis—diagnosing a lot of … women with cancer who were not destined to die from the disease.[1]

This all raises the question: Why the continued emphasis on screening when we have so many studies that all show little benefit to mammograms and in reality significant harms?

Science writer John Horgan in his article Consumers Must Stop Insisting on Mammograms and Other Ineffective Cancer Tests blames the continued use of mammography screening on financial benefits and on consumer demand for testing. About the profit motive he points to an editorial about mammography screening in the British Medical Journal:

“The BMJ editorial urges health-care providers to reconsider priorities and recommendations for mammography screening and other medical interventions.”

“The editorial adds, ‘This is not an easy task, because governments, research funders, scientists, and medical practitioners may have vested interests in continuing activities that are well established’.”

About the consumer demand for testing he says:

“… ultimately, the responsibility for ending the testing epidemic comes down to consumers, who too often submit to — and even demand — tests that have negligible value. Our fear of cancer, in particular, seems to make us irrational. When faced with evidence that PSA tests [yes, prostate cancer as well as thyroid and lung cancer are also overdiagnosed – CL] and mammograms save very few lives, especially considering their risks and costs, many people say, in effect, ‘I don’t care. I don’t want to be that one person in a million who dies of cancer because I didn’t get tested.’ Until this attitude changes, the medical-testing epidemic won’t end.”

Perhaps if they knew that testing may cause them to be one of those several thousand who increase their risk of dying from testing, they would reconsider.

I still remember the commercials made by Sy Syms of discount designer clothing store fame. He would always say: “An educated consumer is our best customer.” For the medical industry, it seems, their best customers are the ones they keep in the dark.

Additional Resources and Reading

Cancer Active
Breast Cancer Action
Screening For Breast Cancer with Mammography
Exposed
The Mammogram Myth: The Independent Investigation Of Mammography The Medical Profession Doesn’t Want You To Know About
Overkill: An avalanche of unnecessary medical care is harming patients physically and financially. What can we do about it?

This article was published originally on Hormones Matter in June 2015. 

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[1] http://jnci.oxfordjournals.org/content/102/9/605.full

This article was published originally on June 20, 2017. 

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The Spin Doctor’s Prescription for Birth Control

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The term ‘Spin Doctor’ wouldn’t be coined until much later, but it was already clear by the time of the Nelson Pill Hearings that some prominent physicians were willing to twist statistics, incorporate doublespeak, and create confusion in any way they could to defend hormonal birth control. They were Spin Doctors in the truest sense. Fortunately, within the context of Senate Hearings, their ‘spin’ was frequently challenged.

Let the Spin Begin

Dr. Robert Kistner from Harvard couldn’t find a bad thing to say about The Pill if his daughter’s life depended on it. However, simple challenges to his testimony made several of his statements seem comical. Consider this exchange with Ben Gordon from Senator Nelson’s staff, when Dr. Kistner compared pill deaths with those of cigarettes:

Dr. Kistner: For every pill-induced death in Britain there are at least 1,500 cigarette induced deaths; based on the total sales of the two products during 1967 one cigarette is three time as dangerous to life as one pill.

Mr. Gordon: Dr. Kistner, may I interrupt for just one moment? Since you compared the risks of smoking with that of the pill, do you know of any cases where smoking three packages of cigarettes has caused either serious illness or death? Three packages?

Dr. Kistner: Smoking three packages?

Mr. Gordon: Right.

Dr. Kistner: Obviously the answer to that question is no.

Mr. Gordon: I have here the proceedings of a conference held… at the headquarters of the American Medical Association… there are case reports, several reports where people have either died or have become seriously injured taking the pill for only 3 months, in other words, three packages of pills.

Dr. Kistner: Is there a cause and effect relationship demonstrated or proved?

Mr. Gordon: Well, it just says “Case reports: Thrombosis and embolism in patients taking the pill.”

Dr. Kistner: There is no cause and effect relationship so far as I can understand.

Mr. Gordon: They said the same thing about tobacco.

Then, there’s this exchange when Senator McIntyre tries to clear up which side effects Dr. Kistner thinks should be shared with women:

Sen. McIntyre: Well, Doctor, there is one thing that occurs to me, could you distinguish for me the difference between a side effect and a complication?

Dr. Kistner: Yes. A side effect of a drug is one that is generally accepted as occurring in some individuals as an undesirable effect other than that for which the drug is given. If one takes estrogen, one frequently becomes nauseated, estrogen “pulls in” sodium and some women don’t excrete the excess fluid and they become edematous and “blow up.” These are side effects: but if a woman takes estrogen and gets a blood clot and dies that is a complication.

Sen. McIntyre: That is more than a complication.

[Laughter]

Dr. Kistner: Well, that is the difference. I think if you asked me to explain the difference, I did.

Today, the spin is just as silly, but the humor is missing. No longer are the distortions challenged. What used to be a laughable punch line is now presented as a valid counterpoint.

Strokes Linked to Hormonal Birth Control

In 2012, the New England Journal of Medicine published the results of an extensive Danish study showing that women on birth control pills or other hormonal contraceptives are up to twice as likely to have a stroke or heart attack than non-users, but a funny thing happened to the story on its way to the press. Industry experts analyzed, mitigated, and diluted it beyond recognition.

ABC News offered the most balanced report. Their story begins with a young woman, a ‘former smoker and birth control pill user’ who suffered a stroke. However, after sharing some of the details of the study, they downplayed the results with the aid of a Spin Doctor, a gynecologist, to be exact, who said, “…pregnancy is far more likely to cause an MI or stroke than hormonal contraception.” Whenever someone dismisses a comprehensive 15-year, peer-reviewed study with a statement like this, they should be required to provide supporting evidence at least as comprehensive as the study itself. In this case, the doctor is repeating an old fallacy – a misinterpretation of statistics that has been around since the beginning of birth control.

Don’t Question Birth Control

One could argue that it is good journalism to seek out a dissenting voice – to effectively present both sides of the story. In this case, I disagree. It’s dangerous. And I have to admit, reading the responses from ‘expert’ physicians frequently brings out my snarky side. Consider the dissenting voices from these spin doctors in articles related to the same Danish study:

Huffington Post interviewed Dr. Diana Petitti, who told them:

“The amount of attention paid to these miniscule risks…detracts attention from more salient issues, like preventing unwanted pregnancy.”

Miniscule risks?! I’m not sure, but I think Dr. Petitti is saying she would rather double her daughter’s chance of having a stroke than risk her getting pregnant.

Later in the same article, Dr. Kathy Hoeger explained:

“The risk might be as much as two times greater, but when you know that the rates are 1 in 10,000, you’re just bringing it up to 2 to 4 in 10,000.”

Those numbers sound so cute, but when you think about an estimated 18 million women in the U.S. currently use hormonal birth control; we could be subjecting an additional 5,400 women per year to strokes and heart attacks.

My favorite may be Dr. Isaac Schiff, who told Boston.com:

“I would say in many ways, this is a good news story. This is a lengthy, large study that helps to confirm that the birth control pill is relatively safe, recognizing that no drug is 100 percent safe.”

He’s ecstatic that hormonal birth control only doubles the risk! He probably turned somersaults when he read that women on The Pill also have a 30% higher risk of developing Multiple Sclerosis, a 50% higher risk of developing Lupus, and could triple their chances of having Crohn’s Disease! (I will talk more about The Pill and the rise of Autoimmune Disease in future posts.)

Dissenting Voices

So, why is it dangerous to present these dissenting voices? Imagine you’re a young woman who’s just been diagnosed with a chronic disease. You begin puzzling the pieces together, and recall that your first symptoms appeared within weeks or months of starting The Pill. You take your suspicions to Google, and stumble upon an article that confirms your fears… or does it?

So, you click on another article. For example, this lupus article that tells you, “The risk was greatest during the first three months after starting “the Pill” — when there was a 2.5-fold increased risk.” You think you’re on to something, but then a prominent doctor from Johns Hopkins is quoted, “One shouldn’t oversell this. Women taking oral contraceptives need to weigh the risk/benefit of unexpected pregnancy versus a very small increase in lupus.” We can’t blame the reader for concluding her diagnosis probably didn’t have to do with The Pill after all.

The Risks versus The Optical Illusions

Optical Illusion - birth control spin

You probably saw this image floating around the internet not too long ago. It reveals a lot about how our brains process information. Our eyes take in all the curves, lighting, and shadows that define Blocks A and B, allowing our brains to analyze the difference in colors. However, when you cover the middle of the image, you discover the blocks are actually the exact same shade.

Only by covering the embellishment do you see the reality.

Media reports on epidemiological studies associated with The Pill often work like this illusion in reverse. They first give us the reality of the image – sharing some of the alarming facts or statistics from the new study. Just as the reader grows concerned that The Pill may be too dangerous, the author bevels the edges, moves the light source, and casts a different shadow.

As laypeople, we tend to assume they know more than us. They minimize the importance of the findings, and we — well, we start to look at it in an entirely different light. We walk away thinking it must not have been as bad as it originally sounded.

We can no longer afford to let reality be obscured by these tactics. Rather than having blind faith in a doctor quoted in some article, we need to consider that we could be dealing with a Spin Doctor. We’ve seen examples of some of these above, but here are five red flags that should make you think twice about the motivation of the speaker:

1) “Those Statistics Aren’t Really That Bad”

Pill proponents will attempt to re-frame numbers so that they seem insignificant. We saw a stereotypical example earlier in this article – “…you’re just bringing it up to 2 to 4 in 10,000.”

Another form of statistical acrobatics seen less frequently today is the attempt to convince us that nature is more dangerous than The Pill. You will recall the gynecologist mentioned early in this article: “…pregnancy is far more likely to cause an MI or stroke than hormonal contraception.”

I believe this method has lost some steam over the years because the mathematical contortions are so easily untangled. Consider this historical example: in his testimony at the Nelson Pill Hearings, Dr. Alan Guttmacher, President of Planned Parenthood/World Population, gave statistics suggesting pregnancy was more dangerous than The Pill (Competitive Problems in the Drug Industry, Ninety-First Congress, Second Session, Page 6565). This was a common argument at the time, but it was refuted beautifully by world-renowned neurologist, Dr. David Clark, speaking to the American Academy of Neurology,

The woman who takes oral contraceptives is, in effect, pregnant and delivering every month. In the normal course of her life, the average American woman has 3.6 pregnancies. She is fertile for approximately 30 years. If she takes oral contraceptives, she will be pregnant and delivering 360 times in that span of time. Expressed differently, she has 90 times more chance of showing the complications of pregnancy.” (Barbara Seaman, A Doctors’ Case Against the Pill, Page 26)

2) “Old Smokers Beware”

Media reports frequently stress that the risk is greatest for women who smoke or are over 35. This is a true statement, but the slight-of-hand comes in the implied message, ‘If you’re young and don’t smoke, you have nothing to worry about,’ which couldn’t be further from the truth.

Sure, they may try to convince you that you have better odds of winning the Publisher’s Clearinghouse than developing a deadly disease, but you don’t want to be on the backside of this one, saying, “That’s what I used to think.”

3) “There is No Proof of an Association”

The US tobacco industry played the ‘Proof versus Evidence’ game masterfully for decades. In 1954, they responded to early lung cancer studies by releasing the ‘Frank Statement to Cigarette Smokers.’ In part, it said:

Distinguished authorities point out…that there is no proof that cigarette smoking is one of the causes.”

As recently as 1998, John Carlisle of the Tobacco Manufacturers Association said:

“There is no such thing as conclusive evidence when you are talking about such a vast subject.”

The subsequent public release of internal communications from the tobacco industry revealed exactly what they knew, and how they strategized to maintain credibility while continuing to deny the overwhelming evidence. While we can’t assume Big Pharma has been consciously playing the same game, there are signs dating back to the early days of The Pill that eerily parallel the tobacco industry’s stance:

  • Complete denial of the association to cancer and strokes
  • Maintain credibility by admitting danger to a ‘small number’ of consumers
  • Agree to include a warning of the dangers with the product

By 1965, Morton Mintz, in the Columbia Journalism Review, expressed dismay at the ‘significant volume of reporting’ in medical journals that attempted to cast doubt on studies by using the argument that The Pill had not been proven unsafe. This was a 180-degree paradigm shift. The FDA had never been required to prove a drug unsafe. The onus was/is on the manufacturer to prove the drug safe. Clearly irritated by the ‘parroting’ in the press, Mintz wrote:

“…there was no acknowledgement that more was required – a disclosure as to specifically what weight of evidence of harm, in the eyes of the advocates, would add up to proof. Also missing was a recognition that for scientists there is no proof in the black-and-white sense, that all that can be had is evidence in one or another shade of gray.”

4) “It Could Have Been Something Else”

This is essentially a nebulous tangent of the ‘Proof vs. Evidence’ game. Despite the fact that criteria for publishing a study are extremely stringent, naysayers will attempt to cast doubt by questioning other variables that could have influenced the study. I recall one doctor actually asking, “How do we know it wasn’t the breakfast cereal the women had been eating that was causing these strokes?”

I suggest to you very few studies get published if they don’t eliminate Cocoa Puffs as a variable.

5) “The Benefits Still Outweigh the Risks”

Then there is the ubiquitous, “The benefits still outweigh the risks.” This phrase, more than any other, makes my head want to explode.

What kind of scale are they using to measure the benefits and risks? Are they looking at the isolated risk in a vacuum, and forgetting about all of the other associated risks? How do you compare a decreased chance of pregnancy with an increased risk of a deadly disease, regardless of percentages on either side, and determine that the benefits outweigh the risks?

Even if there were no other fertility control options available, I cannot grasp the idea of a healthcare professional saying, “Take this pill. It will greatly reduce the likelihood of you getting pregnant, but it doubles your risk of having a stroke…Did I mention that it will help clear your skin?”

Take Your Thumb Off the Scale

Clearly, when weighing the benefits to risks, someone has their thumb on the scale. The result is that there are many prominent physicians willing to perpetuate a pattern of denial and obfuscation anytime a new study is published. We have already seen how medical dogma can trump scientific evidence. So, whenever you read about a new study linking birth control to a deadly disease, remember that the media has run it through a decades-old filter of dogma and distortion. Isolate the Spin Doctor quotes, and take them with a grain of salt. Then, focus on the findings of the study itself. In other words, remove the embellishments and see the reality.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was first published on September 13, 2016. 

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The Disease – Medication Model of Modern Medicine

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As we begin analyzing the data from our studies and I search for ways to quantify the value of our data, I am repeatedly struck by how the business of modern medicine, especially modern pharmaceutically based medicine, has been conceived of, constructed, and is evaluated on a false and outdated premise of separateness. The notion that a disease is a completely discrete entity, that the disease process is linear and that one medication or set of medications impacts only the specified disease, predominates. This is just not so. Life is complicated, disease is even more complicated, and with the exception of perhaps the outright physical trauma of a limb or the need for immediate decision-making in acute or emergent care, nothing is as simple as the one drug, one organ system perspective from which we measure modern healthcare.

As an example, data from our studies are showing complex clusters of adverse reactions that are multi-system and often evade existing diagnostic categories. The symptoms themselves appear to cluster in ways that are unique and will inevitably lead to a deeper understanding of medication reactions, and hopefully, illness itself. For now, however, they appear to defy the logic of current diagnostic categories. The symptoms never quite fit neatly into a single diagnostic box that defines the disease course or guides a treatment plan.

Instead, the symptoms fall into multiple and sometimes contradicting disease categories, and rather than drill down to an appropriate diagnosis, the individuals in our studies have been assigned a long laundry list of apparently, co-occurring diseases; none, accurately characterizing the scope of their illness. When one disease does not capture the full breadth of symptoms, the trend is to add another. If that doesn’t work and when the interaction between the medications creates more unexplainable symptoms, add yet another diagnosis or three or five. Soon the patient has many active diagnoses, with multiple medications to go with. One has to wonder, how so many individuals can have so many diseases at once. Since, I suspect the laws of probability, and indeed, human physiology are contrary to the current multi-disease trend, it leads me to believe that the western model of defining and treating illness, as anatomically and genetically discrete entities, has reached the limits of utility. A paradigm shift may be in order.

Paradigms, especially in medicine and science, are often guided by forces that determine the limits of what can be known, or more cynically, what are considered acceptable pursuits of knowledge and science versus the flights of fancy of fringe scientists. In this case, I would argue that the forces controlling what can be known are those who profit directly from the current diagnostic system – the pharmaceutical industry. The deeply entrenched conflicts of interest between these corporations, policy makers, regulators, politicians, academic institutions, academic journals, medical societies, patient organizations, media organizations – the very ‘thought leaders’ that determine what is valid and what is not – lends credence to these suspicions.

And by every measure, what is currently valid, are the simplistic and discrete categories, with easily identifiable lists of medications for each, where additional diagnoses equal more medication possibilities or in economic terms more product sales opportunities. Whether the symptoms within these disease categories overlap with each other or even represent a true disease process seems to have little bearing on whether a medication can be fit to match a certain set of symptoms and linked to a diagnostic billing code. The diagnostic billing code becomes at once the arbiter of defined diseases and of what can be known about a particular disease. If there is no billing code, read no product or medication opportunity, the disease doesn’t exist, but if there are multiple, overlapping disease categories, no matter how poorly defined or distant from what the patient may actually be experiencing, there is product opportunity, and therefore the disease, or more likely, the diseases he or she is experiencing, exist.  And, if the criteria for defining a particular disease can be relaxed to include more patients and to maximize prescribing opportunities, well then, that is even better.

Consider the most recent recommendation by the American Heart Association and the American College of Cardiology to reduce the risk level for heart attacks necessitating a need for increased prescriptions of statin drugs. The change in guidelines will mean more Americans will be diagnosed with heart disease necessitating prescriptions for the cholesterol lowering drugs, a boon to the drug industry. In a few years, epidemiologists and those who study healthcare trends will report a predictable increase in the number of Americans with heart disease, more money will be poured into preventing heart disease with more medications prescribed and so on. It’s a fantastic business model, control the definition of disease to control the market for products. Will more Americans have heart disease? Not likely, but changing the diagnostic criteria, changing the billing code, to open product markets will give illusion of increasing illness and this benefits the manufacturers of these products.

Unfortunately or fortunately, depending upon which side one is on, lowering the threshold for prescribing opportunities does more than simply increase the number of patients to be given a particular diagnosis, it opens up additional product markets or diagnostic opportunities when the side effects of the primary drug kick in and necessitate treatment. In women, for example, statins increase the risk of Type 2 diabetes. By lowering the criteria for diagnosing heart disease and prescribing statins to more patients, not only will we see an increase in the rates of heart disease in a few years, but because the research tabulating disease rates rely on the diagnostic billing codes, we will also see a corresponding increase in the rate of Type 2 diabetes, most likely created by the increased use of statins. Similarly, because the medication used to treat Type 2 diabetes elicits a corresponding reduction in vitamin B12 levels, which present as a heterogeneous set of neurocognitive symptoms, in a few years, we’ll also see an increased rate of mental health conditions indicated by the growing rates of psychotropic medication prescriptions. And so on.

To be both the arbiter of what is known and can be known, to control the definition of disease and the guidelines for prescribing, is a brilliant business model, but one that does nothing to improve human health, further medical discovery or scientific understanding. Indeed, the survival of this model relies entirely on maintaining the facade of anatomical separateness in disease processes and on not recognizing the totality of medication effects across an entire physiological system. This model relies on remaining ignorant of the inter-connectedness of disease processes and by association the possibility of broad based ‘complicated’ medication reactions.

If diseases remain separate entities and medications work only on specified disease targets, then disease categories remain entirely under the purview of those who stand to benefit from prescribing opportunities. Data that link the onset of a disease to the use of a medication or redefine the scope of a disease process and medication target beyond a specified anatomical region can be easily dismissed. And that is where I find myself, having collected data that questions the accuracy of the current model of anatomically discrete, one medication-one target model of disease. Our data question a paradigm. What does one do with that?

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This article was published originally on November 18, 2013. 

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Latest Gardasil HPV Research Fact or Fiction

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Recently, all the major media reported that the HPV vaccine was working. By their reports, the research showed a 56% reduction in HPV rates for vaccinated girls aged 14-19.

Even a decidedly feminist blog jumped on the bandwagon:

Perhaps one of the only reports to question the validity of these findings comes from an oncology blog for nurses. Assessing the Overall Impact of the HPV Vaccine – well worth the read. Leslie Botha from Holy Hormones Journal adds additional points of contention worthy of consideration. What the rest of the media failed to recognize and repeatedly fails to recognize either by want or by ignorance is that press releases are not often factually correct; something we write about regularly for Gardasil (here, here) and other medications or research (here and here). If a news or media organization is to report on medical and scientific research, they must be prepared to read and critically evaluate the actual research. Otherwise, they ought to label these reports what they are – advertisements.  Here is my take on the latest HPV research.

Behind the PR: Understanding the Research

Every couple years the Centers for Disease Control (CDC) and the National Center for Health Statistics (NCHS) sponsor what are called NHANES studies (National Health and Nutrition Examination Studies). These are health questionnaires sent out to a few thousand individuals deemed to be a representative portion of the population. Depending on the topic of study there are also laboratory based tests and/or in person followups at mobile examination centers (MEC). The study bandied about by the press, was published in the Journal of Infectious Disease (JID) by Markowitz et al., 2013. It compared NHANES data collected from 2003-2006, the pre-vaccine era and from 2007-2010, the post-vaccine era. An earlier study, also published in JID, but authored by Dunn et al. 2011, looked at the NHANES data from 2003-2006 and served as the foundation for Markowitz’s pre-vaccine/post-vaccine HPV analysis.

Background: HPV Prevalence and the Reported Reduction

Even a cursory reading of the Markowitz report – the report on which the PR suggesting HPV success is based –  immediately reveals problems. A deeper dive that includes the earlier JID study, the foundational pre-vaccine data to which the post-vaccine data is compared, demonstrates a statistical sloppiness that is difficult to attribute to ignorance. Numbers are missing, incorrect and misleading.

At the most basic level the data presented about the HPV vaccine’s effectiveness in the reported and marketed extensively by every major and media company are overblown and just a little bit hinky.  While it is true that the researchers report a 56% reduction in HPV rates in girls ages 14-19, that represents only a modest decline in the combined HPV rates (11.5% to 5.1%) tested. What the PR did not mention:

  • Other age groups saw an increase in HPV rates between the pre-vaccine era and post-vaccine era, suggesting that not vaccinating may be better
  • To arrive at this reported 56% reduction for the 14-19 year olds, the researchers had to combine the prevalence rates for each HPV strain tested (not all girls tested positive for all strains), then weight the results and transform – normalize the data to account missing data points and reign in the confidence intervals. The pre-vaccine prevalence rate of 11.5% was arrived at by summing the prevalence rate for each vaccine strain (HPV 6 was 5.4%, HPV 11 was 1%, HPV 16 was 6% and HPV 18 was 1.8%), but we would only know this if we pulled the 2011 study from whence the 11.5% figure came. Markowitz et al. did not annotate this figure. Not all girls had all strains and only HPV 16 and 18 are considered oncogenetic – potentially cancer causing.  Without noting how the 11.5% figure was arrived at and which strains changed from pre- to post-vaccine era, there is no way to determine whether the reduction from 11.5% to 5.1% came from the oncogenic or non-oncogenic strains. Nor is there any way to tell if the prevalence of certain strains increased over time instead of decreased. What if the observed reduction from 11.5% to 5.2% was largely based on HPV 6 – which initiates no more than genital warts?
  • From the total sample of 1363 pre-vaccine era girls and 740 post-vaccine era girls considered, girls from both time periods who were not sexually active and had no record of HPV or vaccine data were included in the original analysis reported in the PR. There was no stratification by these variables in the 56% improvement rate reported.
  • In secondary analysis, when HPV status was evaluated, only a very small sample size of sexually active girls in this age group (111 in the pre-vaccine data and 239 from the post-vaccine data, 8 girls from the post-vaccine sample had no HPV records) were included. These stratified data show that the rate of HPV was lower in non-vaccinated girls at 38.6% compared to 50% in vaccinated girls. So much for the most basic measure of efficacy.
  • The ages of sexually active versus non-sexually active by vaccine status were not given and thus, there is no way to determine whether vaccinating younger, non-sexually active girls has any protective capacity years later when the actual risk for HPV presents.
  • The error rates for some of the reported statistics, hailed as supporting the vaccines were over 30% (how much over, we do not know). Regardless, a >30% error rate is not a acceptable.

Read and Evaluate the Primary Research

Unless and until we get accurate and unbiased data from a large sample, that can be evaluated and verified independently, there is no way to tell if the risks of adverse events associated with this vaccine are reasonable and outweighed by the benefits of preventing cancer. Currently, data collected from the Vaccine Adverse events registry (VAERS) indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. (Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage). This is compared to a risk of cervical cancer of 7.9 per 100,000 and death from cervical cancer at 2.4 per 100,0000 cases in the US. Considering VAERS contains only 1-10% of the total adverse events, the probability increased adverse events is high, so determining the benefits and the efficacy of this vaccine are important.

Who to Trust?

The more the vaccine industry, the CDC, the FDA and other agencies continue to promote truly spurious studies as relevant and proof-positive that a particular vaccine or medication is safe and effective, credibility is lost.  Without an effective counterbalance to the specious claims made by industry, consumers are left fending for themselves. What is perhaps the most dangerous result of this constant barrage of medical marketing and PR is that individuals who may truly benefit from certain vaccines or medications will avoid taking them because of the loss of trust. For the time being, you must pull the research, read and evaluate the studies yourself.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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A Crown for the Worst Headache or Migraine – Medical Marketing Gone Wrong

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As if battling the stigma that surrounds migraine and headache disorders isn’t difficult enough, we can thank Excedrin for continuing it. Excedrin is currently running a sweepstakes called “Who Deserves Excedrin The Most – Help Decide Who Wears the Crown.” In this sweepstakes the idea is to vote on a collection of people or “headache sufferers” who are matched in a daily, “head-to-head” video format, enacting a story and/or situation. The idea is to vote for who deserves to wear “the crown.” E-gift cards are given out every day and your vote is then entered into the pool for the grand prize, a seven day trip for two to Jamaica.

Each of these 16 videos depicts a short story of a particular situation, event or everyday occurrence that in Excedrin’s mind, will give you a “headache.” Some of the videos include rambunctious children in the back seat of a car, the frustration of being on hold for a lengthy amount of time, horrendous flying experiences, raising children, difficult bosses, and completing your taxes at the last minute, to name just a few.

Really. Excedrin wants the public to “crown” someone the Headache King or Queen – celebrate it with a crown, what, like the Burger King? Comedian Molly Shannon is the spokesperson for the sweepstakes and recently said she is a “headache sufferer.” Ms. Shannon can be quite funny and may simply be trying to bring levity to a serious topic. Don’t get me wrong I enjoy a good laugh (even at my own expense) and believe humor plays an important role in our lives. But because the stigma is so high in headache and migraine, I think the slightest amount of banter may increase that stigma, it certainly doesn’t do anything to decrease it.

With over 300 different types of migraine and headache disorders and no test, tool or machine to diagnose them, shouldn’t we be concentrating on more important things than a “crown?” Does anyone ever want to be named the MS King or Breast Cancer Queen in a sweepstakes? Of course not, because the public would never allow that to happen. Here’s the thing – because “it’s just a headache” doesn’t mean we get a “crown” to wear. We all know headache and migraine are so much more than simply a “headache.”  What do you think about Excedrin’s marketing idea?

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Of BPA and Endocrine Disruptors: New Research, Same Flaws

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Bisphenol A or BPA is the ubiquitous estrogenic compound used to create plastics. It leaches into our food stuffs and because of its hormone-like qualities elicits a myriad of health issues in adults but especially in children and most especially when exposed in utero or during key developmental phases.

As we cover the expanding research base on BPA, it becomes increasingly clear that traditional methods of toxicology do not work for understanding endocrine disruptors – the man-made chemicals that alter our hormone pathways . A case in point, the latest research on BPA.

Exposure in Adults

A report published online in June of 2011 and presented at a prominent toxicology conference in February 2013, measured BPA exposure levels over a 24-hour period in adults fed a high BPA diet (lots of canned food and water from plastic bottles). The report showed that the concentration of BPA measured from blood was below the level of detection in most of the study participants, even though urine concentrations were extremely high and indicated exposure levels above the 95th percentile of the US population.

From urine tests, researchers were able to detect an average 84% – 97% of the dosed BPA and its metabolite, BPA glucuronide – indicating a high rate of clearance from the body. The ranges varied widely by time of day (morning tests showed significantly less clearance) and gender of participant (women did not process the hormone as well as men).

The researchers argue that their failure to detect BPA in blood, combined with the high concentration in the urine meant that risk was minimal. Their reasoning, even though BPA exposure was high, most of the BPA was cleared from the body rapidly and efficiently; no harm, no foul.

Medical and science marketers latched on to this and soon every major and minor media outlet was reporting that risks were minimal. Here are just a few headlines.

No Ill Effects Found in Human BPA Exposure, says the Wall Street Journal

Majestically Scientific Federal Study on BPA has Stunning Findings: So Why is the Media Ignoring it? – says Forbes

No toxic effects from controversial food packet, says expert – the Guardian

Ahh, where to begin?

Flaws in the Research

Conflicts of interest. Always look for industry sponsorship of for research, see my previous post on evaluating endocrine research for details. The relationship between the investigators in the present study and industry are muddled, but they do exist. For more information, click here.

Below the level of detection. When researchers report that their tests are unable to detect a visible pathology or measure a particular compound that any reasonable person would expect to be present, the test is likely at fault. Below the level of detection, means just that. It does not mean the compound was not present or that it was not exerting effects, only that the tests were not sensitive enough to measure the compound. This was case here and I suspect as testing methods improve, we’ll see higher detection levels in blood.

High clearance is not the same as never exposed.  In this study, not all of the hormone was recovered in the urine, only an average of 84% – 97%. That sounds like a lot. With hormones, however, small amounts do great damage. Why?  Because steroid hormones are stored in fat (and other tissues). They accumulate over time and metabolize into a myriad of different hormones (metabolites), some more potent than the parent compound. After the initial exposure and certainly after repeated exposures, our bodies become little (or big) hormone factories, storing and creating more and more hormones and hormone metabolites.

Metabolites matter. Hormones are shape shifters. Every time they meet an enzyme, the interaction between the enzyme and the hormone creates a new, similar, but differently shaped hormone. Hormones are never ‘one and done’ metabolizers. Even though a large percentage of the original hormone and its primary clearance metabolite were measured from urine in the present study, one cannot assume that there were not still other metabolites circulating within the body and wreaking havoc.

BPA has metabolites. This is critical and often ignored in toxicology research. BPA is a hormone like substance and as such, it metabolizes into many different forms. BPA has metabolites that are more potent than BPA itself. New research shows that BPA metabolizes into a compound called 4-methyl-2,4-bis(4-hydroxyphenl)pent-1-ene or MBP for short. MBP is 1000-fold stronger than BPA in its estrogenic effects. MBP binds strongly to both types of estrogen receptors (ERa and ERb) and may change the activity of the cell, displacing native or endogenous estradiol. So within that 3%-16% range of BPA not cleared, comes a compound 1000 times stronger than the BPA itself. As the research progresses, who knows how many other active and potent metabolites from BPA or MBP we’ll see. With hormones, nothing is simple or straightforward.

What this Means

Avoid medical marketing, it’s usually incorrect. Learn how to evaluate endocrine disruptor research. Once you get the hang of it, you’ll be able to dismiss faulty research at a glance. More importantly, learn about hormone systems and environmental hormone disrupting chemicals. Otherwise, our children will bear the brunt of our ignorance.

A good review article: Bisphenol A and the Great Divide: A Review of Controversies in the Field of Endocrine Disruption.

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Will the Sunshine Act Curb Pharma Payments to Doctors?

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Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants?  I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

  • 75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
  • 47%  of physicians said the disclosure rules would affect their decision to attend to a great extent.
  • 46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
  • 25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter. 

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Photo by Hush Naidoo Jade Photography on Unsplash.

 

 

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Women’s Hormones: An Intellectual and Ethical Cul de Sac

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Menopause is barreling down with a ferocity that is difficult to ignore. Like many women my age, I’ve had my share of health challenges and, until recently, blindly trusted the pharmaceutical industry to fix all that ailed me. Health by chemistry was a great thing; oral contraceptives, a fabulous invention, allergy meds – ditto, pain killers – wonderful, and on, and on. Take a pill and feel better, isn’t that what we all want? But I, like so many women, have lost faith in pharmaceuticals. It’s not because the science isn’t cool, it is, in every area of pharmacology, except women’s hormone therapies. Here, intellectual curiosity and innovation have been replaced by status quo. Little has changed in this area of hormones and health in 60 years.

Hormones, Hormones, Everywhere and No Innovation in Sight

Since their inception, hormone replacement therapies (HRT) and oral contraceptives have dominated women’s health, immediately moving from seemingly narrow applications when first introduced to the almost mythical status as cure-alls for any female and many general health ailments. The history of both these pills is strikingly inglorious and utterly dumbfounding. Just on general principle, why would anyone believe any medication could be so widely beneficial for so many apparently disparate conditions? It is physiologically impossible.

For HRT especially, if one believes the marketing, the pills provide a veritable fountain of youth. Where is the science? But believe we did, and generations of women may now be paying the consequences.

From the very first estrogens synthesized and marketed to women everywhere (diethylstilbestrol- DES), through today’s HRTs and OCs, profit appears to override health concerns. Even in the 1930’s and 1940s before these drugs came to market, the carcinogenic risks were well known, and yet, they garnered FDA approval and were sold to millions, upon millions of women.

Synthetic Hormones

I have personal experience only with the often ignored side effects of oral contraceptives, as I have yet to reach the age of menopause. In my 20s, while on the presumable high estrogen dose of oral contraceptives that were common then, I had intense bouts of vertigo that would develop even when lying down and ever increasing blood pressure. After years of expensive testing could find no neurological cause for the vertigo and after repeated prescriptions to lower my blood pressure, I stopped taking the pill. I had enough. The vertigo stopped fairly soon thereafter and the blood pressure returned to normal. Over those several years, there was not a single physician that suggested I stop taking the pill, indeed I was prescribed more and more meds to counter the apparently unknown side effects of oral contraceptives and it was recommended I see a shrink because the vertigo had to be psychosomatic.

I look back at that time and I wonder how many other women suffered similar circumstances. What is this propensity to prescribe and continue prescribing medications in the face of apparent ill effects? Why are we ignoring, even at the patient level, the possibility that some meds may not work for some women (or men). The statistics bear this out, but there seems to be a natural inclination to minimize these risks. This is compounded of course, by intense marketing.

As I approach this menopausal stage, I again will be faced with yet another hormone-issue for which the choices are bad and worse. We know from the Women’s Health Initiative (WHI) in 2002, that HRT is not the panacea it was marketed to be and the risks associated with this medication are not benign.

Over a one year period, for every 10,000 women taking and estrogen plus progestin, the risk of developing these conditions increases by:

• Heart disease: 7 additional cases
• Breast cancer: 8 additional cases
• Stroke: 8 additional cases
• Blood clots: 18 additional cases

For estrogen only:

• Stroke: 12 additional cases
• Blood Clots: 6 additional cases

Consider however, the millions of women who will take or have taken HRT for years. As of 2010, over eight million women in the US alone take HRT, and will likely do so for at least a couple years. In this light, the increased risk of disease looks a lot scarier.

• Heart disease: 5600 new cases per year; 28,000 in five years
• Breast cancer: 6,400 new cases per year; 32,000 in five years
• Stroke: 6,400 new cases per year; 32,000 in five years
• Blood clots: 14,400 new cases per year; 72,000 in five years

When the WHI was published, some 17 million women in the US had been taking HRT for many, many years, even decades. That’s 13,600 new cases of breast cancer per year, 68,000 in five years! Despite these data, and the thousands of lawsuits that followed, HRT is still one of the most frequently prescribed medications worldwide. I think we can do better.

Statistics from the Mayo Clinic

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