Women were placed in harm’s way by their physicians, who acted as unsuspecting patsies for the drug companies.
How Did Doctors Not Know About the Risks of Hormone Therapy?
4.2/5 - (96 votes)
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
We’ve known about the role of estrogen in breast cancer going back to the 1800s, when in some cases, surgical removal of the ovaries seemed to help. Ovaries were said to send out mysterious influences to the rest of the body, which, in 1923, we identified as estrogen. The medical profession jumped on this discovery, and started injecting menopausal women by the thousands—shots that gave a respectable hook on which to hang visits to the doctor. Soon, there were pills, and patches, and medical journals—like the Journal of the American Medical Association—regaled doctors with ads on how they can “help women to happiness” by prescribing estrogen. You could turn this into that. “For when women outlive their ovaries,” there was Premarin.
As far back as the 40s, concerns were raised that this practice might cause breast cancer, noting it would have been nice to figure this out first, before we started dosing women en masse. But breast cancer risk didn’t matter, because heart disease is the #1 killer of women, concluded reviews, and because women taking hormones appeared to have lower heart attack rates that would outweigh the extra breast cancer.
But, women taking estrogen tended to be of higher socioeconomic class, tended to exercise more, and engage in other healthy lifestyle changes, like increased fiber intake and getting their cholesterol checked. So, maybe that’s why women taking estrogens appeared to be protected from heart disease. Maybe it had nothing to do with the drugs themselves. Despite the medical profession’s enthusiasm for the stuff, only a randomized clinical trial could really resolve this question—you split women into two groups; half get the hormones; half get a placebo, and you follow them out for a few years. But, there was no such study, until the 1990s, when the Women’s Health Initiative study was designed.
Wait a second. Why did it take the bulk of a century to decide to definitively study the safety of something they prescribed to millions of women? Maybe it’s because there had never been a female director of the National Institutes of Health until then. Just three weeks after being named NIH Director, she went before Congress to announce, “We need a moonwalk for women.” And, that “moonwalk” took the form of the Women’s Health Initiative study.
The bombshell landed. Summer, 2002. There was so much more invasive breast cancer in the hormone users that they were forced to stop the study prematurely. Yeah, but what about heart disease? Wasn’t that supposed to balance things out? The women didn’t just have more breast cancer; they had more heart attacks, more strokes, more blood clots to their lungs.
The news that women treated with hormone replacement therapy experienced higher rates of breast cancer, cardiovascular disease, and overall harm rocked women and physicians across the country. Estrogen started out as the most prescribed drug in America before the study, but the number of prescriptions dropped immediately, and, within a year, so did the incidence of breast cancer in the United States. Here’s the data from California; a nice drop-off in the rate of invasive breast cancer.
But the most important part of this story was why were we all so surprised? There had been decade after decade of repeated warnings about the risks of cancer. In fact, the reason breast cancer patients had so much trouble suing the drug company was that the drugs contained warning labels for decades. And, having disclosed it, surely, any reasonable physician would have included it in their risk and benefit discussion with their patients. It’s like the warning labels on packs of cigarettes. If you get lung cancer, now, you should have known better. And so, if you got breast cancer, don’t blame the drug company. They warned you about the risks, right there, clear as day.
Why didn’t more doctors warn their patients? Even after the study came out, millions of prescriptions continued to be dispensed. That’s a lot of cancer in our patients we caused, wrote one doctor. How long will it take us to stop listening to the drug companies, “admit that we are harming many of our patients, and…start changing our prescription habits?” Why did this practice continue in the face of mounting evidence of harm?
Well, it is a multibillion dollar industry. Despite an overwhelming amount of evidence to the contrary, many physicians still believe that estrogenic hormones have overall health benefits, a non-evidence-based perception that may be the result of decades of carefully orchestrated corporate influence on the medical literature. Dozens of ghostwritten reviews were published in medical journals to promote unproven benefits, and downplay the harms of menopausal hormone therapy. They’d pay PR companies to write the articles, and then pass them off as written by some expert.
So, “gynecologists must switch allegiance from eminence-based to evidence-based medicine”— consider what the science actually says, and not just what some so-called expert says. One might say the “current culture of gynecology encourages the dissemination of health advice based on advertising, rather than science. Women were placed in the way of harm by their physicians, who acted as unsuspecting patsies for the pharmaceutical companies.”
If we really wanted to prevent heart attacks in women, simple lifestyle behaviors can eliminate more than 90% of heart attack risk. So—instead of being Big Pharma’s pawns—recommending a healthful diet, increased exercise, and smoking cessation would truly benefit women’s health.
Please consider volunteering to help out on the site.
- S Boyd. Remarks on Oöphorectomy in the Treatment of Cancer of the Breast. Br Med J. 1899 Feb 4;1(1988):257-62.
- E Allen, E A Doisy. Landmark article Sept 8, 1923. An ovarian hormone. Preliminary report on its localization, extraction and partial purification, and action in test animals. JAMA. 1983 Nov 18;250(19):2681-3.
- G T Beatson. On the Treatment of Inoperable Cases of Carcinoma of the Mamma: Suggestions for a New Method of Treatment, with Illustrative Cases. The Lancet. Volume 148, No. 3803, p162–165, 18 July 1896.
- [No authors listed]. Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group. Control Clin Trials. 1998 Feb;19(1):61-109.
- A J Carstens. HRT prescriptions linked to 25% of breast cancers in California. S Afr Med J. 2009 May;99(5):280.
- A S Robbins, C A Clarke. Regional changes in hormone therapy use and breast cancer incidence in California from 2001 to 2004. J Clin Oncol. 2007 Aug 10;25(23):3437-9.
- J E Rossouw, G L Anderson. R L Prentice, A Z LaCroix, C Kooperberg, M L Stefanick, R D Jackson, S A Beresford, B V Howard, K C Johnson, J M Kotchen, J Ockene; Writing Group for the Women's Health Initiative. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial.Investigators. JAMA. 2002 Jul 17;288(3):321-33.
- P M Ravdin, K A Cronin, N Howlader, C D Berg, R T Chlebowski, E J Feuer, B K Edwards, D A Berry. The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med. 2007 Apr 19;356(16):1670-4.
- L Palmlund. Loyalties in clinical research on drugs: the case of hormone replacement therapy. Soc Sci Med. 2006 Jul;63(2):540-51.
- N Krieger, I Löwy, R Aronowitz, J Bigby, K Dickersin, E Garner, J P Gaudillière, C Hinestrosa, R Hubbard, P A Johnson, S A Missmer, J Norsigian, C Pearson, C E Rosenberg, L Rosenberg, B G Rosenkrantz, B Seaman, C Sonnenschein, A M Soto, J Thornton, G Weisz. Hormone replacement therapy, cancer, controversies, and women's health: historical, epidemiological, biological, clinical, and advocacy perspectives. J Epidemiol Community Health. 2005 Sep;59(9):740-8.
- A Katz. Observations and advertising: controversies in the prescribing of hormone replacement therapy. Health Care Women Int. 2003 Dec;24(10):927-39.
- A Fugh-Berman, C Pearson. The overselling of hormone replacement therapy. Pharmacotherapy. 2002 Sep;22(9):1205-8.
- M J Naughton, A S Jones, S A Shumaker. When practices, promises, profits, and policies outpace hard evidence: the post-menopausal hormone debate. J Soc Issues. 2005 Mar;61(1):159-79.
- R Twombly. So far, victories are few as breast cancer patients sue Wyeth over hormone therapy. J Natl Cancer Inst. 2007 Dec 19;99(24):1828-9, 1835.
- S R Majumdar, E A Almasi, R S Stafford. Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative. JAMA. 2004 Oct 27;292(16):1983-8.
- A J Fugh-Berman. The haunting of medical journals: how ghostwriting sold "HRT". PLoS Med. 2010 Sep 7;7(9):e1000335.
- A R Ford. ‘when Women Outlive Their Ovaries.’ new internationalist issue 165 - November 1986.
- R Whittaker. Re-framing the representation of women in advertisements for hormone replacement therapy. Nurs Inq. 1998 Jun;5(2):77-86.
- E Barrett-Connor. Postmenopausal estrogen and prevention bias. Ann Intern Med. 1991 Sep 15;115(6):455-6.
- H Auchincloss, C D Haagensen. Cancer of the Breast Possibly Induced by Estrogenic Substance. JAMA. 1940;114(16):1517-1523.
- A Fugh-Berman, A R Scialli. Gynecologists and estrogen: an affair of the heart. Perspect Biol Med. 2006 Winter;49(1):115-30.
- L F Hawkinson. The Menopausal Syndrome - One thousand consecutive patients treated with estrogen. JAMA. 1938;111(5):390-393.
- J E McFarland. The menopause. JAMA. 1954;156(13):1273.
- B B Crohn, H D Janowitz. Reflections on regional ileitis, twenty years later. J Am Med Assoc. 1954 Nov 27;156(13):1221-5.
- J Baron, G B Holzman, J Schulkin. Attitudes of obstetricians and gynecologists toward hormone replacement therapy. Med Decis Making. 1998 Oct-Dec;18(4):406-11.
- S R Cummings. Evaluating the benefits and risks of postmenopausal hormone therapy. Am J Med. 1991 Nov 25;91(5B):14S-18S.
- A Akesson, C Weismayer, PK Newby, A Wolk. Combined effect of low-risk dietary and lifestyle behaviors in primary prevention of myocardial infarction in women. Arch Intern Med. 2007 Oct 22;167(19):2122-7.
- Francis S. Collins, M.D., Ph.D. Statement on the Death of Former NIH Director Bernadine P. Healy. National Institutes of Health.
Image thanks to jarmoluk via pixabay
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
We’ve known about the role of estrogen in breast cancer going back to the 1800s, when in some cases, surgical removal of the ovaries seemed to help. Ovaries were said to send out mysterious influences to the rest of the body, which, in 1923, we identified as estrogen. The medical profession jumped on this discovery, and started injecting menopausal women by the thousands—shots that gave a respectable hook on which to hang visits to the doctor. Soon, there were pills, and patches, and medical journals—like the Journal of the American Medical Association—regaled doctors with ads on how they can “help women to happiness” by prescribing estrogen. You could turn this into that. “For when women outlive their ovaries,” there was Premarin.
As far back as the 40s, concerns were raised that this practice might cause breast cancer, noting it would have been nice to figure this out first, before we started dosing women en masse. But breast cancer risk didn’t matter, because heart disease is the #1 killer of women, concluded reviews, and because women taking hormones appeared to have lower heart attack rates that would outweigh the extra breast cancer.
But, women taking estrogen tended to be of higher socioeconomic class, tended to exercise more, and engage in other healthy lifestyle changes, like increased fiber intake and getting their cholesterol checked. So, maybe that’s why women taking estrogens appeared to be protected from heart disease. Maybe it had nothing to do with the drugs themselves. Despite the medical profession’s enthusiasm for the stuff, only a randomized clinical trial could really resolve this question—you split women into two groups; half get the hormones; half get a placebo, and you follow them out for a few years. But, there was no such study, until the 1990s, when the Women’s Health Initiative study was designed.
Wait a second. Why did it take the bulk of a century to decide to definitively study the safety of something they prescribed to millions of women? Maybe it’s because there had never been a female director of the National Institutes of Health until then. Just three weeks after being named NIH Director, she went before Congress to announce, “We need a moonwalk for women.” And, that “moonwalk” took the form of the Women’s Health Initiative study.
The bombshell landed. Summer, 2002. There was so much more invasive breast cancer in the hormone users that they were forced to stop the study prematurely. Yeah, but what about heart disease? Wasn’t that supposed to balance things out? The women didn’t just have more breast cancer; they had more heart attacks, more strokes, more blood clots to their lungs.
The news that women treated with hormone replacement therapy experienced higher rates of breast cancer, cardiovascular disease, and overall harm rocked women and physicians across the country. Estrogen started out as the most prescribed drug in America before the study, but the number of prescriptions dropped immediately, and, within a year, so did the incidence of breast cancer in the United States. Here’s the data from California; a nice drop-off in the rate of invasive breast cancer.
But the most important part of this story was why were we all so surprised? There had been decade after decade of repeated warnings about the risks of cancer. In fact, the reason breast cancer patients had so much trouble suing the drug company was that the drugs contained warning labels for decades. And, having disclosed it, surely, any reasonable physician would have included it in their risk and benefit discussion with their patients. It’s like the warning labels on packs of cigarettes. If you get lung cancer, now, you should have known better. And so, if you got breast cancer, don’t blame the drug company. They warned you about the risks, right there, clear as day.
Why didn’t more doctors warn their patients? Even after the study came out, millions of prescriptions continued to be dispensed. That’s a lot of cancer in our patients we caused, wrote one doctor. How long will it take us to stop listening to the drug companies, “admit that we are harming many of our patients, and…start changing our prescription habits?” Why did this practice continue in the face of mounting evidence of harm?
Well, it is a multibillion dollar industry. Despite an overwhelming amount of evidence to the contrary, many physicians still believe that estrogenic hormones have overall health benefits, a non-evidence-based perception that may be the result of decades of carefully orchestrated corporate influence on the medical literature. Dozens of ghostwritten reviews were published in medical journals to promote unproven benefits, and downplay the harms of menopausal hormone therapy. They’d pay PR companies to write the articles, and then pass them off as written by some expert.
So, “gynecologists must switch allegiance from eminence-based to evidence-based medicine”— consider what the science actually says, and not just what some so-called expert says. One might say the “current culture of gynecology encourages the dissemination of health advice based on advertising, rather than science. Women were placed in the way of harm by their physicians, who acted as unsuspecting patsies for the pharmaceutical companies.”
If we really wanted to prevent heart attacks in women, simple lifestyle behaviors can eliminate more than 90% of heart attack risk. So—instead of being Big Pharma’s pawns—recommending a healthful diet, increased exercise, and smoking cessation would truly benefit women’s health.
Please consider volunteering to help out on the site.
- S Boyd. Remarks on Oöphorectomy in the Treatment of Cancer of the Breast. Br Med J. 1899 Feb 4;1(1988):257-62.
- E Allen, E A Doisy. Landmark article Sept 8, 1923. An ovarian hormone. Preliminary report on its localization, extraction and partial purification, and action in test animals. JAMA. 1983 Nov 18;250(19):2681-3.
- G T Beatson. On the Treatment of Inoperable Cases of Carcinoma of the Mamma: Suggestions for a New Method of Treatment, with Illustrative Cases. The Lancet. Volume 148, No. 3803, p162–165, 18 July 1896.
- [No authors listed]. Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group. Control Clin Trials. 1998 Feb;19(1):61-109.
- A J Carstens. HRT prescriptions linked to 25% of breast cancers in California. S Afr Med J. 2009 May;99(5):280.
- A S Robbins, C A Clarke. Regional changes in hormone therapy use and breast cancer incidence in California from 2001 to 2004. J Clin Oncol. 2007 Aug 10;25(23):3437-9.
- J E Rossouw, G L Anderson. R L Prentice, A Z LaCroix, C Kooperberg, M L Stefanick, R D Jackson, S A Beresford, B V Howard, K C Johnson, J M Kotchen, J Ockene; Writing Group for the Women's Health Initiative. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial.Investigators. JAMA. 2002 Jul 17;288(3):321-33.
- P M Ravdin, K A Cronin, N Howlader, C D Berg, R T Chlebowski, E J Feuer, B K Edwards, D A Berry. The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med. 2007 Apr 19;356(16):1670-4.
- L Palmlund. Loyalties in clinical research on drugs: the case of hormone replacement therapy. Soc Sci Med. 2006 Jul;63(2):540-51.
- N Krieger, I Löwy, R Aronowitz, J Bigby, K Dickersin, E Garner, J P Gaudillière, C Hinestrosa, R Hubbard, P A Johnson, S A Missmer, J Norsigian, C Pearson, C E Rosenberg, L Rosenberg, B G Rosenkrantz, B Seaman, C Sonnenschein, A M Soto, J Thornton, G Weisz. Hormone replacement therapy, cancer, controversies, and women's health: historical, epidemiological, biological, clinical, and advocacy perspectives. J Epidemiol Community Health. 2005 Sep;59(9):740-8.
- A Katz. Observations and advertising: controversies in the prescribing of hormone replacement therapy. Health Care Women Int. 2003 Dec;24(10):927-39.
- A Fugh-Berman, C Pearson. The overselling of hormone replacement therapy. Pharmacotherapy. 2002 Sep;22(9):1205-8.
- M J Naughton, A S Jones, S A Shumaker. When practices, promises, profits, and policies outpace hard evidence: the post-menopausal hormone debate. J Soc Issues. 2005 Mar;61(1):159-79.
- R Twombly. So far, victories are few as breast cancer patients sue Wyeth over hormone therapy. J Natl Cancer Inst. 2007 Dec 19;99(24):1828-9, 1835.
- S R Majumdar, E A Almasi, R S Stafford. Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative. JAMA. 2004 Oct 27;292(16):1983-8.
- A J Fugh-Berman. The haunting of medical journals: how ghostwriting sold "HRT". PLoS Med. 2010 Sep 7;7(9):e1000335.
- A R Ford. ‘when Women Outlive Their Ovaries.’ new internationalist issue 165 - November 1986.
- R Whittaker. Re-framing the representation of women in advertisements for hormone replacement therapy. Nurs Inq. 1998 Jun;5(2):77-86.
- E Barrett-Connor. Postmenopausal estrogen and prevention bias. Ann Intern Med. 1991 Sep 15;115(6):455-6.
- H Auchincloss, C D Haagensen. Cancer of the Breast Possibly Induced by Estrogenic Substance. JAMA. 1940;114(16):1517-1523.
- A Fugh-Berman, A R Scialli. Gynecologists and estrogen: an affair of the heart. Perspect Biol Med. 2006 Winter;49(1):115-30.
- L F Hawkinson. The Menopausal Syndrome - One thousand consecutive patients treated with estrogen. JAMA. 1938;111(5):390-393.
- J E McFarland. The menopause. JAMA. 1954;156(13):1273.
- B B Crohn, H D Janowitz. Reflections on regional ileitis, twenty years later. J Am Med Assoc. 1954 Nov 27;156(13):1221-5.
- J Baron, G B Holzman, J Schulkin. Attitudes of obstetricians and gynecologists toward hormone replacement therapy. Med Decis Making. 1998 Oct-Dec;18(4):406-11.
- S R Cummings. Evaluating the benefits and risks of postmenopausal hormone therapy. Am J Med. 1991 Nov 25;91(5B):14S-18S.
- A Akesson, C Weismayer, PK Newby, A Wolk. Combined effect of low-risk dietary and lifestyle behaviors in primary prevention of myocardial infarction in women. Arch Intern Med. 2007 Oct 22;167(19):2122-7.
- Francis S. Collins, M.D., Ph.D. Statement on the Death of Former NIH Director Bernadine P. Healy. National Institutes of Health.
Image thanks to jarmoluk via pixabay
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Title
How Did Doctors Not Know About the Risks of Hormone Therapy?
LicenseCreative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
Content URLDoctor's Note
The whole Premarin debacle speaks to the importance of putting purported therapies to the test (see, for example, Do Vitamin D Supplements Help with Diabetes, Weight Loss, and Blood Pressure?), as well as to the power of Big Pharma (Eliminating Conflicts of Interest in Medical Research), medical community collusion (American Medical Association Complicity with Big Tobacco), and my recent series on mammograms.
What about Plant-Based Bioidentical Hormones and Soy Phytoestrogens for Menopause Hot Flashes? Check out the videos to find out.
2023 Update: What about estrogen that can be applied locally? See Hormone Treatment (Estrogen Pills and Creams) for Vaginal Menopause Symptoms.
In general, patients (and doctors) tend to wildly overestimate the efficacy of pills and procedures. See Why Prevention Is Worth a Ton of Cure and The Actual Benefit of Diet vs. Drugs.
Medical care, in general, may be the third leading cause of death in the United States. See How Doctors Responded to Being Named a Leading Killer.
Is FDA-Approved Bioidentical Hormone Replacement Therapy Safe? Check out the video.
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