To build muscle & lose fat, you need a variety of proteins, veggies, fruits, carbs, and healthy fats. Eating protein helps building & maintaining muscle. But it also helps fat loss: protein has a higher thermic effect than carbs/fats.
Eating fats also helps fat loss: your body holds fat if you don’t eat fats. Fruits & veggies contain vitamins & minerals, necessary for recovery from your workouts. And carbs fuel your muscles so you feel full of energy at the gym.
Lots of you struggle to get these foods. Sometimes because you’re too busy or sometimes because you just lack information. This list will help you — 20 super foods you need to build muscle & lose fat.
1. Whole Eggs. Cheap & rich source of protein: 7g/egg. The yolk contains most nutrients: half the protein, vitamins A/D/E and cholesterol to naturally increase your testosterone levels.
Don’t worry about cholesterol in eggs. Dietary cholesterol isn’t bound to blood cholesterol. Read this, this, this & this. If you have bad cholesterol, lower your body fat rather than throwing the yolk away.
2. Fish Oil. Reduces inflammation (joints/skin), lowers body fat and increases testosterone levels. You need 9000mg EPA/DHA per day. Since you’ll probably struggle to get that from eating fatty fish, consider a fish oil supplement.
3. Wild Salmon. One of the best sources of omega-3 fatty acids that also gets you 20g protein per 100g serving. Farm raised salmon is, however, omega-3 deficient: it’s corn/grain fed. Go with wild salmon.
4. Berries. Strong antioxidants that prevent cancer, heart & eye diseases. Any kind works: cranberries, raspberries, blackberries, blueberries, etc. Buy fresh or frozen berries and mix with oatmeal.
5. Yogurt. Contain bacteria that improve your gastrointestinal health. Don’t buy frozen yogurt or yogurt with added sugar and fruits at the bottom. Get plain low fat yogurt. Eat it with berries & flax seeds.
6. Flax Seeds. Source of fiber, protein & omega-3. Grind the flax seeds to get the most out of them. Take 1 tbsp with yogurt & berries before going to bed. Stay away from flax oil: it’s unstable and contains no fiber.
7. Extra Virgin Olive Oil. 70% monounsaturated fats that protect against heart diseases and cancer. Add 1-2 tbsp olive oil to your salads. Buy Extra Virgin Olive Oil: it contains more polyphenols and tastes better.
8. Mixed Nuts. Contain mono- & polyunsaturated fats, proteins, fiber, vitamin E, zinc, potassium, magnesium, etc. Mixed nuts are caloric dense, great if you’re a skinny guy who wants to gain weight.
Anything works: almonds, walnuts, cashews, hazelnuts, … Peanut butter also works as long as you buy natural peanut butter without added salts/sugars.
Image credit: Inside_man
9. Red Meat. Protein, vitamin B12, heme iron, zinc, creatine, carnosine and even omega-3 if you eat grass-fed beef. Eat steaks & hamburgers from top round or sirloin. Read Dr. Lonnie Lowery’s article on Meat.
10. Broccoli. High in cancer-fighting phytochemicals and anti-estrogenic indoles. Broccoli is also high in soluble fiber and low calorie, helping fat loss. Eat other cruciferous vegetables for a change: cabbage, bok choy, cauliflower, kale, …
11. Spinach. One of the most alkaline foods. Spinach prevents muscle & bone loss, but also cancer and heart diseases because of its high nutrient profile. Try one of the spinach recipes I shared a while back.
12. Turkey. If you don’t believe saturated fat is good for you, try white turkey. The leanest beef has about 4.5g saturated fat/100g, while white turkey has close to 0g (that why it’s so dry). Eat turkey with spinach & quinoa.
13. Quinoa. South American “king of grains”. Quinoa is higher in fiber & protein than rice or oats, tastes a lot better and is gluten free. Buy the whiter grain, it’s better quality. Eat it post workout with meat & spinach.
14. Oats. Reduce cholesterol, provide you with low-gi carbs for energy, and high in soluble fiber. Try this post workout shake of whey & oats.
15. Tomatoes. High in lycopene, which prevents cancer. The lycopene in tomato paste is 4 times more bioavailable than in fresh tomatoes. Have pizza or pasta with tomato sauce & olive oil post strength training.
16. Oranges. Vitamin C to fight diseases, magnesium to lower blood pressure, anti-oxidant beta-carotenes, etc. Quit drinking processed orange juice which often has added sugars. Eat oranges or make your own orange juice.
17. Apples. Pectin in apples helps weight loss by increasing satiety. Apples are also the strongest antioxidiant after cranberries (eat the peels). Unfortunately apples are one of the most pesticide-contaminated fruits. Go organic.
18. Carrots. Their huge vitamin A content improves eye-health, especially night vision. Carrots are also rich in fiber, low calorie and taste good, even raw.
19. Water. Your body holds water if you don’t drink enough. Drinking prevents water retention, helps muscle recovery and prevents dehydration from strength training. Get a brita filter and drink 2 cups of water with each meal.
20. Green Tea. Strong antioxidant and natural diuretic. Green tea also speeds up fat loss, prevents cancer and improves blood sugar & circulation. Drink green tea in the morning instead of coffee. Real green tea, not the teabags.
Putting it All Together. Eat proteins, veggies, fruits & fats every 3 hours. 2 cups water with each meal. Carbs post workout only. Junk food 10% of the time. Get stronger in the meanwhile and you’ll build muscle & lose fat.
Monday, January 11, 2010
Sunday, January 10, 2010
This is why Wyeth is Out of Business! Let's Get Smarter and Change The Standard of Care
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.”
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.”
Chemosensitivity Tests – Why Does Big Pharma Know About Them and WE Don’t?
By Suzanne Somers:
After a show at ShopNBC, my family took me out to dinner for my birthday at a fancy restaurant in Minneapolis, called The Kitchen (spectacular, by the way!). A man at the table across from us started by buying two very nice bottles of wine for our table. By the end of the evening, he decided to buy the entire dinner! I went to his table to thank him. Turns out he owns a pharmaceutical company (that explains the extravagant gift!). He was a very nice man and went on to tell me his wife had recently died of cancer. We started talking about my book, KNOCKOUT: Interviews with Doctors Who Are Curing Cancer and How to Prevent Getting it in the First Place. When the subject of chemosensitivity tests came up, he mentioned his wife had one during the course of her treatment, even still she could not be saved.
While the owner of a big pharmaceutical company knew the term and asked for this test for his own wife, the term “chemosensitivity test” would fail to be recognized by most Americans. However, this concept is well known in other parts of the world. For instance, in Germany, chemosensitivity tests are routinely conducted in order to determine which type of chemo should be utilized for a specific cancer patient. In KNOCKOUT, Dr. James Forsythe explains that in both Germany and Greece, specialists begin by harvesting the cancer cells out of the patient’s blood. They then break down the cells genetically in order to discover which markers are compatible with treatment of the tumor. From this, they can tell which drugs would be most effective for the particular cancer, which ones would be ineffective, or harmful. Once the correct type of chemo has been determined, Dr. Forsythe uses an integrative treatment, with far lower doses of chemo (10-20% of the norm), far fewer side effects, and much better results.
We are all aware that the purpose of chemo is to kill cancer cells, but that it also kills our healthy cells along the way. With the right fit, the correct chemo can target and kill cancer cells so that at least when we are choosing to add this poison into our systems we know it will do its intended job. Dr. Forsythe illustrates the impact of this testing by sharing one of his patient’s stories. He begins, “I had a patient from Sacramento who six months ago had been on a heavy-duty chemo protocol called FOL-FOX (containing oxaliplatin, 5FU, and Avastin). We found out from the German chemosensitivity test that two out of the three of those drugs were completely ineffective against his cancer cells. I switched him over to a sensitive drug and he’s now out playing golf three days a week and his liver has cleared up completely on recent follow-up scans” (KNOCKOUT, p.128).
If these tests could help us to take less chemo, or a better chemo for our specific cancer, why wouldn’t we ALL be given these tests? Experts say it’s too long of a process and too much trouble, so they make the best guess possible and hope it works. Dr. Robert Nagourney in Long Beach, California, and Larry Weisenthal in Huntington Beach, California, are the only two American doctors who run these tests. Otherwise, we don’t bother to go through this step of chemotherapy sensitivity testing before administering a poison that could be completely ineffective and damaging to our immune system. I wasn’t even told this testing was an option for me in either of my two diagnoses. Why not? Why not find out if at least there is a shot that the chemo being administered will have any effect? I suspect the reason is that if this poison doesn’t fit, someone will lose the revenue.
I have also learned about this major issue through my friend, Farrah Fawcett’s experience. She underwent two courses of excruciating, debilitating, immune-system-ruining chemotherapy for anal cancer – only to have the cancer return in three months. Then she traveled to Germany and was told upon doing a chemosensitivity test that the chemo she had been administered in our country had been completely ineffective. A waste of time. Useless. All it did was seriously degrade her health. Perhaps this explains Bill Faloon’s thought process when he says, “The second biggest killer in America is medical ignorance and it is the number one reason people die” (KNOCKOUT, p. 254).
Now that I realize chemosensitivity tests exist, it feels unconscionable that chemotherapy would ever, ever be administered without testing first to find out if the chemo is even compatible with the specific cancer. Big Pharma knows about these tests… and the man who bought my birthday dinner insisted for his own wife. Why doesn’t everyone have access to the same knowledge and treatment?
If you would like to find out more about chemosensitivity testing, read KNOCKOUT or consult the following resources:
Biofocus Institute for Laboratory Medicine
Dr. med Dipl. Chem. Doris Bachg
Dr. med Uwe Haselhorst
Berghauser Str. 295
45659 Recklinghausen, Germany
Contact: Dr. Lothar Prix
+49 2361-3000-130
+49 2361-3000-169 (fax)
Email: prix@biofocus.de
Research Genetic Cancer Centre (R.G.C.C.)
P.O. 53070 Florina, Greece
+30-24630-42264
+30-24630-42265 (fax)
E-mail: jpapasot@doctors.org.uk
After a show at ShopNBC, my family took me out to dinner for my birthday at a fancy restaurant in Minneapolis, called The Kitchen (spectacular, by the way!). A man at the table across from us started by buying two very nice bottles of wine for our table. By the end of the evening, he decided to buy the entire dinner! I went to his table to thank him. Turns out he owns a pharmaceutical company (that explains the extravagant gift!). He was a very nice man and went on to tell me his wife had recently died of cancer. We started talking about my book, KNOCKOUT: Interviews with Doctors Who Are Curing Cancer and How to Prevent Getting it in the First Place. When the subject of chemosensitivity tests came up, he mentioned his wife had one during the course of her treatment, even still she could not be saved.
While the owner of a big pharmaceutical company knew the term and asked for this test for his own wife, the term “chemosensitivity test” would fail to be recognized by most Americans. However, this concept is well known in other parts of the world. For instance, in Germany, chemosensitivity tests are routinely conducted in order to determine which type of chemo should be utilized for a specific cancer patient. In KNOCKOUT, Dr. James Forsythe explains that in both Germany and Greece, specialists begin by harvesting the cancer cells out of the patient’s blood. They then break down the cells genetically in order to discover which markers are compatible with treatment of the tumor. From this, they can tell which drugs would be most effective for the particular cancer, which ones would be ineffective, or harmful. Once the correct type of chemo has been determined, Dr. Forsythe uses an integrative treatment, with far lower doses of chemo (10-20% of the norm), far fewer side effects, and much better results.
We are all aware that the purpose of chemo is to kill cancer cells, but that it also kills our healthy cells along the way. With the right fit, the correct chemo can target and kill cancer cells so that at least when we are choosing to add this poison into our systems we know it will do its intended job. Dr. Forsythe illustrates the impact of this testing by sharing one of his patient’s stories. He begins, “I had a patient from Sacramento who six months ago had been on a heavy-duty chemo protocol called FOL-FOX (containing oxaliplatin, 5FU, and Avastin). We found out from the German chemosensitivity test that two out of the three of those drugs were completely ineffective against his cancer cells. I switched him over to a sensitive drug and he’s now out playing golf three days a week and his liver has cleared up completely on recent follow-up scans” (KNOCKOUT, p.128).
If these tests could help us to take less chemo, or a better chemo for our specific cancer, why wouldn’t we ALL be given these tests? Experts say it’s too long of a process and too much trouble, so they make the best guess possible and hope it works. Dr. Robert Nagourney in Long Beach, California, and Larry Weisenthal in Huntington Beach, California, are the only two American doctors who run these tests. Otherwise, we don’t bother to go through this step of chemotherapy sensitivity testing before administering a poison that could be completely ineffective and damaging to our immune system. I wasn’t even told this testing was an option for me in either of my two diagnoses. Why not? Why not find out if at least there is a shot that the chemo being administered will have any effect? I suspect the reason is that if this poison doesn’t fit, someone will lose the revenue.
I have also learned about this major issue through my friend, Farrah Fawcett’s experience. She underwent two courses of excruciating, debilitating, immune-system-ruining chemotherapy for anal cancer – only to have the cancer return in three months. Then she traveled to Germany and was told upon doing a chemosensitivity test that the chemo she had been administered in our country had been completely ineffective. A waste of time. Useless. All it did was seriously degrade her health. Perhaps this explains Bill Faloon’s thought process when he says, “The second biggest killer in America is medical ignorance and it is the number one reason people die” (KNOCKOUT, p. 254).
Now that I realize chemosensitivity tests exist, it feels unconscionable that chemotherapy would ever, ever be administered without testing first to find out if the chemo is even compatible with the specific cancer. Big Pharma knows about these tests… and the man who bought my birthday dinner insisted for his own wife. Why doesn’t everyone have access to the same knowledge and treatment?
If you would like to find out more about chemosensitivity testing, read KNOCKOUT or consult the following resources:
Biofocus Institute for Laboratory Medicine
Dr. med Dipl. Chem. Doris Bachg
Dr. med Uwe Haselhorst
Berghauser Str. 295
45659 Recklinghausen, Germany
Contact: Dr. Lothar Prix
+49 2361-3000-130
+49 2361-3000-169 (fax)
Email: prix@biofocus.de
Research Genetic Cancer Centre (R.G.C.C.)
P.O. 53070 Florina, Greece
+30-24630-42264
+30-24630-42265 (fax)
E-mail: jpapasot@doctors.org.uk
PREMPRO IS NOT A HORMONE ANY WOMAN SHOULD BE TAKING
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.
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. This is all true if you replace hormones with actual hormones, not synthetically and chemically changed hormones.
“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 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.
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. Because these drugs were not bioidentical hormones and do not behave the same when taken orally and are chemical mistakes of the actual hormone.
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 are getting hormones "replaced" which is not the case with drugs like Premarin or Prempro.
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.
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.
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. This is all true if you replace hormones with actual hormones, not synthetically and chemically changed hormones.
“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 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.
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. Because these drugs were not bioidentical hormones and do not behave the same when taken orally and are chemical mistakes of the actual hormone.
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 are getting hormones "replaced" which is not the case with drugs like Premarin or Prempro.
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.
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.
Reader Survey: Will the USPSTF Breast Cancer Screening Recommendations change what you do?
Clinical Guidelines
Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement
From the U.S. Preventive Services Task Force, Agency for Healthcare Research and Quality, Rockville, Maryland.
Description: Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for breast cancer in the general population.
Methods: The USPSTF examined the evidence on the efficacy of 5 screening modalities in reducing mortality from breast cancer: film mammography, clinical breast examination, breast self-examination, digital mammography, and magnetic resonance imaging in order to update the 2002 recommendation. To accomplish this update, the USPSTF commissioned 2 studies: 1) a targeted systematic evidence review of 6 selected questions relating to benefits and harms of screening, and 2) a decision analysis that used population modeling techniques to compare the expected health outcomes and resource requirements of starting and ending mammography screening at different ages and using annual versus biennial screening intervals.
Recommendations: The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient's values regarding specific benefits and harms. (Grade C recommendation)
The USPSTF recommends biennial screening mammography for women between the ages of 50 and 74 years. (Grade B recommendation)
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. (I statement)
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination beyond screening mammography in women 40 years or older. (I statement)
The USPSTF recommends against clinicians teaching women how to perform breast self-examination. (Grade D recommendation)
The USPSTF concludes that the current evidence is insufficient to assess additional benefits and harms of either digital mammography or magnetic resonance imaging instead of film mammography as screening modalities for breast cancer. (I statement)
The U.S. Preventive Services Task Force (USPSTF) makes recommendations about preventive care services for patients without recognized signs or symptoms of the target condition.
It bases its recommendations on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit of the service.
The USPSTF recognizes that clinical or policy decisions involve more considerations than this body of evidence alone. Clinicians and policymakers should understand the evidence but individualize decision making to the specific patient or situation.
Previous SectionNext SectionSummary of Recommendations and Evidence
The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. This is a C recommendation.
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. This is a B recommendation.
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. This is an I statement.
The USPSTF recommends against teaching breast self-examination (BSE). This is a D recommendation.
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. This is an I statement.
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer.
For a summary of the evidence systematically reviewed in making these recommendations, the full recommendation statement, and supporting documents, please go to www.preventiveservices.ahrq.gov
Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement
From the U.S. Preventive Services Task Force, Agency for Healthcare Research and Quality, Rockville, Maryland.
Description: Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for breast cancer in the general population.
Methods: The USPSTF examined the evidence on the efficacy of 5 screening modalities in reducing mortality from breast cancer: film mammography, clinical breast examination, breast self-examination, digital mammography, and magnetic resonance imaging in order to update the 2002 recommendation. To accomplish this update, the USPSTF commissioned 2 studies: 1) a targeted systematic evidence review of 6 selected questions relating to benefits and harms of screening, and 2) a decision analysis that used population modeling techniques to compare the expected health outcomes and resource requirements of starting and ending mammography screening at different ages and using annual versus biennial screening intervals.
Recommendations: The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient's values regarding specific benefits and harms. (Grade C recommendation)
The USPSTF recommends biennial screening mammography for women between the ages of 50 and 74 years. (Grade B recommendation)
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. (I statement)
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination beyond screening mammography in women 40 years or older. (I statement)
The USPSTF recommends against clinicians teaching women how to perform breast self-examination. (Grade D recommendation)
The USPSTF concludes that the current evidence is insufficient to assess additional benefits and harms of either digital mammography or magnetic resonance imaging instead of film mammography as screening modalities for breast cancer. (I statement)
The U.S. Preventive Services Task Force (USPSTF) makes recommendations about preventive care services for patients without recognized signs or symptoms of the target condition.
It bases its recommendations on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit of the service.
The USPSTF recognizes that clinical or policy decisions involve more considerations than this body of evidence alone. Clinicians and policymakers should understand the evidence but individualize decision making to the specific patient or situation.
Previous SectionNext SectionSummary of Recommendations and Evidence
The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. This is a C recommendation.
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. This is a B recommendation.
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. This is an I statement.
The USPSTF recommends against teaching breast self-examination (BSE). This is a D recommendation.
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. This is an I statement.
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer.
For a summary of the evidence systematically reviewed in making these recommendations, the full recommendation statement, and supporting documents, please go to www.preventiveservices.ahrq.gov
