This important New York Times article provides a comprehensive review of how Big Pharma’s synthetic “hormones” (Prempro and Premarin) have backlashed for women, causing disease, lawsuits, and a huge decrease in sales. I was interviewed for this article on menopause (read through to the end) to discuss bio-identical hormones, as a follow up from my books, The Sexy Years and Ageless.   

Menopause, as Brought to You by Big Pharma 

By NATASHA SINGER and DUFF WILSON

Published: December 12, 2009  

MILLIONS of American women in the 1990s were told they could help their bodies ward off major illness by taking menopausal hormone drugs. Some medical associations said so. Many gynecologists and physicians said so. Respected medical journals said so, too.  Along the way, television commercials positioned hormone drugs as treatments for more than hot flashes and night sweats — just two of the better-known symptoms of menopause, which is technically defined as commencing one year after a woman’s last menstrual cycle.

 

One commercial about estrogen loss by the drug maker Wyeth featured a character named Dr. Heartman in a white coat discussing research into connections between menopause and heart disease, Alzheimer’s disease and blindness.   “When considering menopause, consider the entire body of evidence,” Dr. Heartman said. “Speak to your doctor about what you can do to help protect your health during and after menopause.”

 

Connie Barton, then a medical office assistant in Peoria, Ill., was one woman who responded to such messages. She says she took Prempro, a hormone drug made by Wyeth, from 1997, when she was 53, until 2002, when she received a diagnosis of breast cancer. As part of her cancer treatment, she had a mastectomy to remove her left breast.  Now Ms. Barton, who said in an interview that she used Prempro in part because her doctor told her it could help prevent heart disease and dementia, is one of more than 13,000 people who have sued Wyeth over the last seven years, claiming in courts across the country that its menopause drugs caused breast cancer and other problems.   The suits also assert, based on recently unsealed court documents, that Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks.

 

In October, a jury in a Pennsylvania state court awarded Ms. Barton $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million.   The drug giant Pfizer, which absorbed Wyeth and its hormone drugs in a merger this year, says that Prempro is a safe, federally approved drug that did not cause Ms. Barton’s breast cancer. Chris Loder, a Pfizer spokesman, says Wyeth acted responsibly by including a clear warning about a breast cancer risk on Prempro labels and by updating the warning as new evidence emerged.

 

Mr. Loder also notes that Pfizer plans to appeal every product-liability case on menopausal drugs it loses, including Ms. Barton’s.   While Wyeth has faced periodic complaints about its blockbuster menopause drugs, the latest lawsuits have turned the company’s menopausal hormone franchise into the kind of case study dissected at Ivy League business schools. Lawyers have made some documents public in the suits, and The New York Times and the nonprofit Public Library of Science filed successful motions to unseal thousands of documents in July.

 

To be sure, even some doctors who think hormone therapy has risks say it is the most effective treatment for symptoms directly associated with menopause.  The documents that have surfaced in the Wyeth cases offer a rare glimpse inside the file cabinets and hard drives of a major drug company. And the cases demonstrate the importance of litigation in detailing exactly how drug makers operate their businesses, says Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School who has written about the subject in The Journal of the American Medical Association.

 

“The information coming out in litigation helps us understand how a belief in a ‘protective benefit’ of estrogens on the heart was able to spread like wildfire through the medical community,” says Dr. Avorn, who is not involved in the Wyeth litigation.  “Thousands of doctors prescribed the drugs for millions of women on that basis,” he says, adding that studies later contradicted the belief. “It will be very interesting to see whether the courts are able to connect the dots and make it clear whether this was a kind of medical ventriloquism on Wyeth’s part.”

 

PREMPRO is a combination of Premarin, an estrogen drug derived from the urine of pregnant mares and first approved by the Food and Drug Administration in 1942, with an additional hormone, progestin.  Part of the Premarin saga shows how a drug maker successfully and cannily expanded a franchise whose central ingredient is horse estrogens into a billion-dollar panacea for aging women. Yet several hundred pages of court documents also raise questions about another aspect of Premarin’s trajectory: how Wyeth worked over decades to maintain the image and credibility of its hormone drugs even as the products were repeatedly under siege.

 

Pfizer representatives say court documents paint an unfair picture of Wyeth’s practices and that plaintiffs’ lawyers have cherry-picked documents for out-of-context comments to sway juries. Still, the documents offer a snapshot of Wyeth’s efforts. Taken together, they depict a company that over several decades spent tens of millions of dollars on influential physicians, professional medical societies, scientific publications, courses and celebrity ads, inundating doctors and patients with a sea of positive preventive health messages that plaintiffs’ lawyers say deflected users’ attention from cancer concerns.

 

Even as evidence mounted of an association of the drugs with cancer — first in the 1970s with Premarin and endometrial cancer, then in the 1990s with Prempro and breast cancer — Wyeth tried to contain the concerns, the court documents show. (A note handwritten in 1996 by a Wyeth employee responding to a new report of breast cancer risks associated with hormone therapy said: “Dismiss/distract.”)

 

In 2002, researchers halted the largest clinical trial ever conducted of women’s health because participants who took certain combined hormones had an increased risk of breast cancer — as well as a higher risk of heart attack, stroke and blood clots in the lungs — compared with those taking a placebo.   Other parts of the same federal study, called the Women’s Health Initiative, later found that hormone drugs increased the risk of dementia in a subset of participants, those age 65 and older.   Sales of Wyeth’s hormone drugs peaked at about $2 billion in 2001, but after results of the 2002 study came out sales plummeted.

 

Pfizer is now fighting the Prempro litigation along with lawsuits over its progestin drug, Provera. Mr. Loder, the Pfizer spokesman, says Pfizer and Wyeth had fully informed patients, doctors and regulators of the risks of their menopause drugs, based on the best available science at the time of the disclosures.“They provided accurate warnings, performed studies on benefits and risks, and kept the F.D.A. fully informed,” he says.  But last month, a federal appellate court in St. Louis ruled in the case of a plaintiff named Donna Scroggin that Wyeth’s inaction over accumulating evidence — and the company’s attempts to mitigate cancer concerns by trying to undermine unfavorable scientific reports — could allow a jury to find Wyeth guilty of malicious conduct and award punitive damages.   For its part, Pfizer contends that two state judges in Pennsylvania have reached the opposite conclusion: that juries should not be allowed to award punitive damages because there was insufficient evidence of corporate misconduct.

 

Whichever direction the different cases ultimately follow, the court papers associated with them illustrate a pattern in the history of hormone therapy. First, many doctors enthusiastically prescribe hormone therapy drugs. Then a few researchers publish studies cautioning about risks, causing sales to fall. And finally, some doctors start prescribing a new iteration of hormone drugs.

 

For example, Prempro now comes in lower doses. Prempro labels say the drug should be prescribed for the shortest duration appropriate for the treatment goals and risks of the individual woman; previous labels on Wyeth’s hormone drugs for decades gave the same advice. The current label also says that using estrogens, with or without progestins, may increase a woman’s chance of heart attack, stroke, breast cancer and blood clots.

 

MENOPAUSAL hormone therapy has long been pitched as a way to stave off what some doctors viewed as the undesirable aspects of female aging.

 

In the popular 1966 book “Feminine Forever,” Dr. Robert A. Wilson, a gynecologist, used disparaging descriptions of aging women (“flabby,” “shrunken,” “dull-minded,” “desexed”) to upend the prevailing idea of menopause as a normal stage of life. Women and their physicians, Dr. Wilson wrote, should regard menopause as a degenerative disease that could be prevented or cured with the use of hormone drugs.

 

“No woman can be sure of escaping the horror of this living decay,” Dr. Wilson wrote. “There is no need for either valor or pretense. The need is for hormones.”

 

Premarin had been available for decades, but Dr. Wilson’s book propelled the idea of hormone “replacement” into the popular consciousness and onto physicians’ prescription pads. The revivifying drugs promised to inhibit the ravages of time on the appearance and the psyche, Dr. Wilson wrote.

As the popularity of estrogen grew, an increasing number of women developed cancer of the uterine lining, the endometrium. In 1975, an F.D.A. panel concluded there was a link between Premarin and endometrial cancer. The company then sent a letter to doctors trying to mitigate such concerns, documents show.

 

“Dear Doctor,” wrote Dr. John B. Jewell, at the time the medical director of Ayerst, the Wyeth predecessor. “It would be simplistic indeed to attribute an apparent increase in the diagnosis of endometrial carcinoma solely to estrogen therapy.” Women may still receive “proven benefits,” he wrote, by using “the lowest maintenance dose needed to control the menopausal symptoms.” He added that the company planned to study the issue further.

 

F.D.A. officials then met with company officials, saying they were “incensed” that the letter was “intended to obfuscate the issues,” according to a 1976 memo signed by the F.D.A. and the company. The F.D.A. said it would issue a bulletin saying there was a clear link between estrogen therapy and endometrial cancer. In 1976, the maker of Premarin added a warning to the label about the risk of endometrial cancer.

 

But the company never conducted further studies on the risk of developing endometrial cancer, according to the St. Louis appeals court decision.

 

The company instead focused its risk research on the possibility of breast cancers associated with hormone replacement therapy. But two studies published in the mid-1970s in The New England Journal of Medicine reported that taking estrogen therapy had increased the risk of endometrial cancer by at least five times.

 

Reports in 1975 about endometrial cancer “resulted in a precipitous decrease in estrogen use,” according to a history of hormone therapy in The American Journal of Medicine in 2005.   In 1980, researchers at Boston University Medical Center estimated that the use of hormone therapy had caused more than 15,000 cases of endometrial cancer in the United States between 1971 and 1975 alone.

 

“This represents one of the largest epidemics of serious iatrogenic disease” — meaning disease caused by physician-administered treatments — “that has ever occurred in this country,” the authors wrote. (Mr. Loder said Pfizer was not familiar with that report.)

 

Today, physicians prescribe Premarin to women who have had hysterectomies and therefore are not at risk for endometrial cancer.

 

BY the mid-1990s, after a few studies had reported a protective effect of hormone drugs on the heart, Wyeth had begun to reposition menopausal hormone therapy as a preventive health choice that could help inhibit heart disease and other maladies, according to court documents.

That marketing strategy coincided with the introduction of Wyeth’s new combination hormone drug Prempro, which included a progestin hormone to keep estrogen from causing excessive cell growth in the uterine lining.

 

In one commercial from a Wyeth research institute, the model Lauren Hutton runs down a beach and warns of the health risks of estrogen loss.

 

“My doctor said if you don’t replace estrogen that you lose at menopause, your risk for certain age-related diseases could increase,” Ms. Hutton said in the commercial. In a voice-over, a narrator told viewers about studies looking into the connections between menopause and heart disease, memory loss and sight loss.

 

“Believe me,” Ms. Hutton said, “the time to protect your future is now.”

 

Sally Beatty, a spokeswoman for Pfizer, said this was a “help seeking” ad, of the type encouraged by the F.D.A. She added that the promotion did not mention any specific drugs, not did it suggest that drugs could cure the ailments described.

 

The labels for Premarin and Prempro at the time said the drugs were approved to treat moderate to severe symptoms of menopause like hot flashes, night sweats and vaginal dryness and to prevent osteoporosis.

 

But Wyeth also positioned its menopausal hormone drugs as having larger protective benefits, court documents show.

 

Wyeth used proxies to promote a wide range of health benefits from hormone therapy, paying millions of dollars to influential doctors and medical groups and helping them develop abstracts for medical conferences and articles for medical journals, according to court documents.

 

The company also paid $12 million to sponsor continuing medical education programs from 2002 through 2006 at the University of Wisconsin, Madison. The programs, including an assertion that the Women’s Health Initiative and another heart-risk study “miss the mark on quality of life,” reached thousands of doctors.

 

Doctors were aware in the 1990s that hormone therapy could increase a woman’s risk of breast cancer, says Dr. Carol Bates, the director of the primary care program at Beth Israel Deaconess Medical Center in Boston.

 

But based on the results of observational studies that had been published, many physicians, herself included, believed that the drugs’ ostensible ability to reduce heart attacks and perhaps Alzheimer’s would outweigh a breast cancer risk, she says.

 

“In the 1990s, there was actually tremendous pressure to put women on hormone therapy, and it came from a good place,” Dr. Bates says. “But it was taken a bit to the extreme.”

 

HORMONE therapy — aimed at the symptoms it effectively treats and with full disclosure about its possible risks — has many advocates. Dr. Lynne T. Shuster, the director of the women’s health clinic at the Mayo Clinic in Rochester, Minn., says such regimens can be very worthwhile for treating hot flashes, night sweats and vaginal dryness associated with menopause.

And some users agree.

 

Irene Fisher, a kitchen and bath designer in Baldwin, N.Y., says she has been taking Prempro for 16 years to control hot flashes and night sweats.

 

“I always feel good when I take it,” she says. The benefits are worth a small risk, Ms. Fisher says, adding that she has an annual mammogram to check for breast cancer and that “I think you have to know your own body.”

 

But many women were not so fully informed in the 1990s.

 

In 1996, for example, a federal study reported that breast cancer risk may have been “substantially underestimated.” Wyeth reacted with plans to dismiss it as “just one more paper,” and try to “overshadow” it by directing journalists to other studies, according to documents cited in the court of appeals decision in Missouri.

 

In 1997, Wyeth began working with DesignWrite, a company in Princeton, N.J., that is paid by drug makers to develop manuscripts for publication in medical journals. The specific objective of a publication plan for Premarin was to “increase physician awareness on the multitude of benefits that hormone replacement therapy provides” and “diminish the negative perceptions associated with estrogens and cancer,” according to a 1997 DesignWrite proposal prepared for Wyeth.

 

Over the next decade, Wyeth paid DesignWrite to prepare at least 60 articles for publication in medical journals on the potential benefits of hormone therapy for cardiovascular disease, Alzheimer’s disease, diabetes, colon cancer, vision loss and other health problems, the court documents show.

 

In response to an e-mail query, Michael Platt, president of DesignWrite, wrote that the articles were all medically and scientifically accurate and valid and peer reviewed.   But Wyeth’s and DesignWrite’s effort hit an obstacle in 2002 when researchers reported the results of the Women’s Health Initiative.

The National Institutes of Health ultimately decided to start using the term “menopausal hormone therapy” instead of “hormone replacement therapy,” says Marcia L. Stefanick, a professor of medicine at the Stanford University medical school who was principal investigator on the Women’s Health Initiative study at her institution.

 

While the drugs are effective at treating symptoms like hot flashes, she says, the word “replacement” implies that women need hormone drugs after menopause. “But there is no good evidence that women need this after menopause,” Professor Stefanick says.

 

In 2003 Wyeth added a “black box” warning to the label saying Prempro should not be prescribed to prevent cardiovascular disease.   The same year, the F.D.A. approved a lower dose version of Prempro so women would have more options.

 

Today, many doctors who once offered hormone therapy to women without symptoms like hot flashes limit the use of the drug to those with symptoms, prescribing low doses for a short time.  “Right now, the big difference is we do not recommend hormone therapy for good health or health promotion or anti-aging,” says Dr. Shuster of the Mayo Clinic.  And even with lower-dose hormones, doctors do not have a uniform view on what constitutes the optimal duration.

 

Dr. Adriane Fugh-Berman, an associate professor at the medical school of Georgetown University, considers both Premarin and Prempro examples of drugs that gained widespread popularity before science had established the full extent of their risks.

 

“Where there has always been a push is where there isn’t data,” says Dr. Fugh-Berman, who has been a paid expert witness for plaintiffs in the hormone litigation. “Now, low-dose hormones are being pushed.”

 

LIKE Dr. Wilson, the gynecologist in the 1960s who identified the evils of menopause, contemporary voices are advocating hormones as an anti-aging treatment.

 

The actress Suzanne Somers, for example, has identified her own lineup of maladies, which she calls the Seven Dwarves of Menopause: “Itchy. Bitchy. Sweaty. Sleepy. Bloated. Forgetful. All Dried Up.”   In books with titles like “The Sexy Years” and “Ageless,” Ms. Somers has promoted the use of “bio-identical” hormones, which can be prescribed by doctors in customized doses and can be prepared individually by pharmacies. 

 

But Dr. Shuster of the Mayo Clinic says the hormones have not been extensively studied for safety and efficacy. And, unlike branded hormone therapy, she says, they have not been approved by the F.D.A.   Women, Dr. Shuster says, should not assume that compounded hormones are safer than F.D.A.-approved menopausal hormone drugs. Nevertheless, with sales of more than two million books, Ms. Somers has become a menopause guru to millions.

 

“I think I had a lot to do with making the word ‘menopause’ mentionable,” Ms. Somers, 63, said in a phone interview last week. She said the compounded hormones were safe, and she sent some articles from medical journals to back up her point.

 

In fact, much of Ms. Somers’s description of menopause as a deficiency that can be rebalanced with hormones sounds like a modern take on “Feminine Forever.”

 

“Hormones,” Ms. Somers said last week, “are the juice of life.”

 

Sincerely,

 

Suzanne Somers

 

For  more information, visit www.SuzanneSomers.com

This is an article from The Desert Sun written about my book, Knockout: Interviews with Doctors Who are Curing Cancer and How to Prevent Getting It in the First Place.  It came right after a party I threw at my desert home for the doctors and professionals who contributed to the book.  As mentioned in this article, I looked around that table and felt honored to be in the presence of the most forward-thinking minds in treatments and cures for cancer.  I felt emotional  because in my heart, I really feel that the cure for cancer is within reach with these outstanding professionals.  It’s a hopeful way to start this new decade.  For more information about alternative treatments for cancer, read Knockout. 

 

The Desert Sun – Mydesert.com

 Suzanne Somers widening the search for a cure for cancerAfter being diagnosed with cancer twice, Suzanne Somers is on a controversial mission to educate others about alternative therapies 

By: Bruce Fessier

December 6, 2009

 

The limits of America's arsenal in the fight against cancer became clear to Kathleen Greene of Palm Springs last month when a family member was diagnosed with breast cancer.  Chemotherapy seemed inevitable, but a Reader's Digest article told her of a promising alternative called laetrile.  “They said a group of scientists from around the world had gone to the Himalayas 10 years ago to try to find out what these people were doing differently than everybody else,” Greene told The Desert Sun. “They found they were eating the pits of apricots and they called (its vitamin) laetrile.  “The frustration is they're still doing chemotherapy. They're still doing all these other things when other treatments are available. They're killing your cells and you lose your hair from this chemo and maybe all they had to have was laetrile. I think we're in the dark ages in medicine.”

 

The success of Palm Springs resident Suzanne Somers' latest book, “Knockout: Interviews With Doctors Who Are Curing Cancer and How to Prevent Getting It In the First Place,” indicates more than a million readers also are interested in alternative cancer treatments. The book shot to No. 1 on the New York Times best-seller list in its first week of release in October.  Somers, who campaigned for alternative medicine with three previous books on bioidentical hormones, wrote “Knockout” after being misdiagnosed with cancer just over a year ago at a hospital she won't identify. She threw herself into a search for possible cancer cures, interviewing health experts and both alternative and conventional doctors to help others deal with a trauma she's been through twice — she was treated for breast cancer with radiation and alternative therapies in 2001.  Somers, however, has faced criticism for hyping alternative cancer therapies that haven't been approved by the Food and Drug Administration, and in some cases, have yet to be peer reviewed or published.

 

Dr. Otis Brawley, chief medical officer for the American Cancer Society, confronted her last month on “Larry King Live” and told The Associated Press, “I am very afraid that people are going to listen to her message and follow what she says and be harmed by it.”

 

But Somers, who at 63 still has the youthful smile that brought her fame in the 1970s as the ditzy blonde on “Three's Company,” says her book sales indicate people are hungry for more information on cancer treatments.

 

“What that says to me is people know there's got to be something better,” she said at her multi-level Palm Springs home. “I talk about chemotherapy and where it doesn't work, but that's not really the focus of this book. It's to get you thinking about options.  If I had had this book available the two times I was diagnosed, I would have been so grateful. When you're presented with a cancer diagnosis, you get the standard of care (options) — surgery, radiation, chemotherapy and whatever after-care drug is for your particular cancer. No one has ever said to me, ‘If that doesn't appeal to you, you can always try X — the other way.'”  Doctors must present patients with standard of care options that have been established by the medical community and reinforced by insurance and court mandates. But not everyone in the medical establishment believes the options need to end there.

 

Dr. Joseph E. Scherger, Vice President for primary care at Eisenhower Medical Center, is spearheading that hospital's effort to create a new model for primary care using tools of the Information Age. He says patients and doctors should consider all valid treatments for chronic illnesses. “It used to be that the general public really did not have access to enough information to make their own decisions well,” he said. “They'd go to doctors and be told what to do. But now, in this Information Age, patients really have the opportunity, if not the obligation to become an expert in themselves.” Scherger says different cancer doctors have different biases.  “If you're a cancer surgeon, you like to do surgery. If you're an oncologist, you give chemotherapy. If you're a radiation oncologist you provide radiation.

 

He encourages conferences with various doctors and invites patients to hear their advice and evidence about the different options available. He says even the idea of getting a second opinion from an outside source is outdated.  “Now, patients are capable of talking to their own social network,” he said. “If they go on a web site like PatientsLikeMe (.com), they can log into thousands of people who have the same cancer they do. There's an interesting book, ‘What Would Google Do' (by Jeff Jarvis). At the end of the book, he's got a ‘What a Google health system would look like,' and he basically says, ‘Go public with your medical information and you'll get the best care because there's a wisdom of crowds to help you out.' So it's really not about one or two doctors' opinions any more.”  Scherger, founding dean of the Florida State University College of Medicine, says the 21st century model for primary care should include alternative medicine if patients want it.  “If alternative therapies are not going to be harmful and the patients believe in them or want them, you need to be supportive,” he said. “I think the goal is not an either or when it comes to alternative medicine versus conventional, scientific medicine. What you've got to realize is, it is their body. You want to keep them on the program to get the best medical care while being supportive of their beliefs.”

  

‘Truth about healing'

But Somers and some alternative doctors say a medical community supported by pharmaceutical research grants won't listen to advocates of natural health products that aren't eligible for patents.

“The thing I didn't say (on ‘Larry King Live') was, ‘Until you can say after all the billions of dollars that have been thrown into research that you have a cure, you owe it to us — the patients — to listen to what everybody is doing,” Somers exclaimed. “If (Dr. Stanislaw) Burzynski has a 60 percent success rate with the most virulent brain tumor, like Ted Kennedy just died of, why won't you go to Burzynski's clinic (in Houston)? I walked through his lab and different floors. The Burzynski kids with brain tumors are running around. This is a happy place because they're not all drugged out.”  Burzynski, who has been approved for Stage III clinical trials by the FDA on a cancer treatment that activates what he calls cancer protective genes, was one of many doctors Somers recently praised at a party at her home.  Another was medical author Ralph Moss, Ph.D., who was fired from a public relations job at Memorial Sloan-Kettering Cancer Center in New York in 1977 after accusing Sloan-Kettering officials of stopping their fight for clinical trials on laetrile because they had “lost their nerve” in the face of opposition from the FDA and the medical establishment.  Another was Bill Faloon, director and co-founder of the Life Extension Foundation, which has been fighting the FDA for non-pharmaceutical cancer therapies since 1980.  “The reason there is not a cure for cancer is the regulatory structure,” he said at the party. “There are enough effective therapies to cure cancer, but the regulators themselves impede the progress. The FDA is the roadblock.”

 

Somers looked at the doctors sitting at a U-shaped table in the natural amphitheater that is her back patio and said, “I think the answer to cancer is sitting around this table. I think you are leaders in your fields. You have forced those on the other side to take a good hard look at themselves.  “I am so proud to be the filter, the messenger.”  But alternative doctors say their work would probably fall on deaf ears without her.

 

“She's only the messenger, but she's the truth,” said Dr. Stephen Sinatra, a cardiologist and psychotherapist. “She's got the big name to warn the United States and expose the myth and tell the truth about healing. She's a beacon of light and a diamond in the rough. She will change the way cancer is treated in this country.”  Somers said meeting with the doctors gave her hope.  “When I finished writing this book, I said to my husband, ‘I no longer fear cancer,'” she said. “I don't ever want it again, but, if I get it, I'm never going to fear that hopeless panic I've felt now twice. I know which doctor I would go to and which protocol I would use depending on the cancer.  “What I want from this book is to happen to the reader what happened to me. If reading this book can do that for the reader, that's very empowering.”

Sincerely,

Suzanne Somers

For more information, visit www.SuzanneSomers.com

After I wrote the blog – “Mammograms – Yes, No, Maybe So?” Dr. Russell Blaylock sent me this follow-up. He is an expert in this field, and I greatly respect his opinion.

Dr. Blaylock:

What women who defend mammograms do not appreciate is that many are developing breast cancer not naturally, but because of the mammograms themselves. The test they defend is what is killing a significant number of them. We went through this in the 70’s with routine chest x-ray studies; after several years of such screening they realized that it was not detecting enough pathology to justify the expense, but many physicians also recognized that it posed a significant radiation-induced cancer risk as well.

They will never admit to the radiation (mammogram) breast cancer link because that will tell women that many of them developed breast cancer because of the screening itself and that could severely damage the cancer establishment. And it could result in a massive number of lawsuits.

Why don’t we advocate “testiculograms” (I made this term up) on men - that is placing their testicles into a “panini” type of press machine, then radiating them - once a year starting at age 20. After all, it may save the lives of hundreds of men every year! We could even sell pink oval shaped decals to promote yearly “testiculograms” and have marathons to draw support. And we might even promote yearly CT scans of the prostate for men—that would save thousands from prostate cancer—if we apply the same flawed way of thinking we use for mammograms. Let’s see how many men show up for their yearly testiculogram or prostate scan. Just a thought.

As for the data on the benefits of mammograms, 10 of the largest studies seeking to determine if routine mammograms indeed prevented death from breast cancer - studies which included a half-million women from Canada, USA, Scotland and Sweden - all found that doing mammograms from age 40 to 49 did not reduce breast cancer deaths at all for 9 years of the survey. Nine of ten of the studies also found no death reductions over the next 10 to 14 years of observations. When they pooled all the results from all 10 of the trials, they found no reductions in breast cancer deaths during an observation period of 14 years.

When they looked at screening beginning at age 50, 3 found a statistically significant reduction, 4 found non-significant reductions and 1 found no reductions in breast cancer deaths at all. When they looked at women who started mammogram screenings at age 50 years and followed them for the next 20 years (age 70), they found a reduction in breast cancer deaths of 1 out of every 270 women (a 0.37% incidence of reduced deaths).

The vast majority of breast cancers found in women below age 50 are DCIS (ductal carcinoma in situ) and 50% never progress. These women will undergo unnecessary biopsy, breast surgery and, for many, radiation and chemotherapy.

One must also consider two other factors - false negatives and false positives. Women with breast cancer who have a false negative mammogram constitute some 5-20%, with the highest number being younger women. This means that 20% of younger women will have breast cancer that will not be picked up by the mammogram.

Mammograms expose women to a significant amount of radiation. We know that breast tissue is one of the more radiosensitive tissues. This is especially so for the woman with the BRCA 1 and 2 mutation and the woman who already have a DCIS (non-progressive in over 50% of cases). The radiation, based on extensive studies, would more than likely convert a non-progressive cancer into a highly invasive cancer in a number of instances. Remember, radiation is an accumulative tissue damaging agent - each mammogram will produce a certain amount of DNA and cellular damage that goes unrepaired. Women with inflammatory breast diseases are at an even greater risk, because the high level of free radical and lipid peroxidation damage also damages the DNA repair enzymes, and this means an even greater level of unrepaired DNA with each mammogram. This explains the 1-3% accumulative risk with each mammogram.

It is also known that radiosensitivity declines with aging as does the growth rate of cancers. A woman in her 50’s or 60’s will have a slower growing cancer than will a woman in her 20’s to 40’s. Likewise, because of the gap between radiation exposure and the development of the cancer, the hope of these mammogram proponents is that starting the mammograms at age 50 will mean that most women will die of other diseases, such as cardiovascular diseases, before she will develop a radiation-induced breast cancer. This is especially so if they change mammograms to every other year. For the woman living into her 80’s or 90’s - she will face a significant risk of a radiation-induced breast cancer. Also of concern are the women with the DCIS, which in over 50% of cases will never become a true invasive cancer. Yet, we know that in these breast lesions exist very unstable chromosomes. Radiating such lesions year after year greatly increases the risk that these benign lesions will become highly malignant. That is, the mammogram itself will induce the cancer. Millions of women have DCIS type lesions and most would never be any worse off if they never knew it. Now we have millions of women with DCIS being radiated every year and this assures that many will develop a highly invasive, deadly cancer caused by the scanning itself.

Women have an alternative. They can have a thermogram, an ultrasound or an MRI scan. None of these tests increase a woman’s risk of developing breast cancer. The mammogram defender will counter that the thermograms have not been proven effective - but then, they refuse to fund testing. They admit the MRI gives a much clearer picture of the breast, especially for very dense breasts (which for the mammogram cannot be read), but then claim that it will result in too many false positives. As we have seen, mammograms have a false positive rate of 90% (some 300,000 women undergo biopsies for false positive mammograms a year). How much higher could it be with MRI scans - 95%? They refuse to give up mammograms because they have spent billions on special breast scanning suites and expensive mammogram equipment - it is big business and it would be an admission that they have been harming and killing thousands of women.

Suzanne Somers