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URGENT: YOUR ACTION NEEDED NOW!

Wyeth Pharmaceuticals Petitions FDA to Prohibit Your Access to Bio-Identical Hormones.

On October 16 th, 2005, Wyeth Pharmaceuticals, the maker of Premarin and Prempro, petitioned the Food and Drug Administration (FDA) to impose restrictions on the manufacture and sale of bioidentical hormones. If passed, this legislation would severely limit your right to access safe and effective natural hormone replacement therapy.

Wyeth, a leading manufacturer of FDA-approved estrogen hormone therapy drugs, filed a “Citizens Complaint” with the FDA alleging that compounding pharmacies are putting women’s health at risk by promoting the sale of bioidentical hormones as a “safe alternative” to the conventional FDA approved hormones.

They claim this is misleading the public and state that there is “inadequate data to demonstrate safety or efficacy” of bioidentical hormones. Furthermore, they recommend that the FDA take immediate action against all pharmacies, in the form of “seizures, injunctions and/or warning letters”, engaged in compounding “bioidentical hormone replacement therapy” drugs.

BIOIDENTICAL HORMONES VS. SYNTHETIC HORMONE

Bioidentical hormones are not new. They have been around and safely used for over twenty years in the treatment of menopausal symptoms with relatively few side effects. They are manufactured from plants, such as soy and wild yam, to have the same identical molecular structure as hormones made by our own body. Because they are identical in structure to our own hormones they are safer and have fewer side effects than do synthetic hormones.

By contrast, synthetic hormones, such as Premarin, intentionally are made to look different from our own body’s hormones. Natural hormones cannot be patented so pharmaceutical companies must alter the hormone chemically in order to hold onto the manufacturing rights. Because synthetic hormones are different from our own body’s hormones they are stronger and have many undesirable side effects such as blood clots, breast cancer, heart attacks and stroke.

YOU NEED TO ACT NOW! Wyeth Pharmaceuticals would like the FDA to take away your right to choose safe and effective natural, bio-identical hormones.

We have until April 4, 2006 to stop them. At that time the FDA will makes its decision. Voice your opposition to the Wyeth Complaint by writing the FDA and tell them your story about the benefits that bioidentical hormones have made in your life.

We need to let the FDA know that thousands of women rely on bioidentical hormones as a safe alternative to conventional synthetic hormones.

To file a comment online please go to: http://www.fda.gov/ohrms/dockets/

You may fax your comment to The Division of Dockets Management / FDA at (301) 827-6870.

The Wyeth petition is docket number 2005P-0411.

By L. A. Aziz

There’s a long and discouraging list of known risk factors for breast cancer. They range from early periods and late childbirth to lack of exercise, high-fat diets and alcohol consumption. Genetics and age also play a role in predicting the risk. But the most damning risk factor of all, of course, is simply being a woman.

It’s a tough enough life when every choice you make appears to increase your chances of getting the disease. But no woman expects that the very screening tool used to identify breast cancer should increase her lifetime risk. Yet last June, the National Toxicology Program at the National Institutes of Health released its Eleventh Report on Carcinogens in which ionizing radiation, including the 15 percent that occurs during medical procedures, was identified as a known human carcinogen. This revelation, alongside the well-documented shortcomings of mammography, outlined in a previous column, has reignited a public cry for research into alternative and less invasive breast cancer screening options.

An option

One of the screening tools that deserves a closer look is thermography. An infrared imaging technology, thermography requires neither radiation nor breast compression. Instead, it is based on the principle that metabolically active pre-cancerous and cancerous sites grow and spread by establishing new networks of blood vessels, which, in turn, can raise the surface temperature of skin by as much as 3°C. It is these revealing “hotspots” that are visible on a thermogram. Proponents of thermography believe that these early warning spots can be detected anywhere from 5 to 10 years before a tumor is palpable through breast self-examination or is visible on a mammogram.

Whereas mammography relies on structural anomalies to identify cancer in the breast tissue, thermography, in theory, can identify physiological changes long before tumors even appear. If the treatment of breast cancer is a war won early, then thermography — and, more importantly, women — deserve a fighting chance.

Its history

There are more than 800 studies listed in Index Medicus related to breast screening thermography. The results, however, are mixed and the studies are inconsistent, which explains, in part, why the procedure has drifted in and out of favor since it was first used as a screening tool in 1956. From the 1960s through the 1970s, thermography was used in thousands of clinics in the United States, but it wasn’t until 1982 that the Food and Drug Administration sanctioned breast screening thermography as an “adjunctive” screening procedure under the 1976 Medical Device Amendment (MDA) to the Food, Drug, and Cosmetic Act. (Curiously, however, mammography, which was already in widespread use when the MDA came into effect, was grandfathered in under the new regulations and never subjected to rigorous safety and effectiveness approvals.) A few large studies from the late 1970s and early-1980s showed that thermography had lower predictive accuracy rates than mammography and was marred by inconsistency and troubling false positives. By the 1990s, thermography had fallen out of favor with both the American Medical Association and the Canadian Association of Radiation Technologists.

Lack of consistency, however, has yet to slow mammography’s march into mainstream cancer-screening consciousness. In 2001, a 16-person interdisciplinary committee from the Institute of Medicine (IOM) and the National Research Council (NRC) undertook a comprehensive review to examine the state of early breast cancer detection and identify promising new technologies. In its final report, Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer, the panel identifies potential strengths of non-invasive infrared thermography and notes that the major hindrance to widespread acceptance of thermography has been old technology and a lack of clinical data. The editors add that in recent years, advancements in infrared imaging technology for a variety of military and security applications have increased thermography’s accuracy, making it better suited for screening applications. At the same time, increasingly sophisticated computer software reduces some of the subjectivity of interpreting thermograms.

Can it stand alone as a screening tool?

No one knows yet. Currently, thermography is not recommended as a replacement for mammography. Instead, research such the 2003 “Efficacy of Computerized Infrared Imaging Analysis to Evaluate Mammographically Suspicious Lesions” by Y. R. Parisky et al in the American Journal of Radiology shows that infrared imaging offers a safe noninvasive adjunctive screening companion to mammography in determining whether a lesion is benign or malignant. In combination, the two tools surpass the current performance of either on its own.

Tantalizing tidbits give consumers hope for an alternative in the future. A 1996 study showed thermographic imaging identified increases in temperature and the formation of blood vessels in 86 percent of cancers that were not palpable and 15 percent which were not visible on a mammogram. Influential bodies such as the IOM/NRC review panel notes that “preclinical data are suggestive that the technology might be useful for breast cancer detection, but the clinical data are absent or very sparse.”

What’s next?

The tenacious and troubling nature of breast cancer has renewed attention on the issue of early detection. We remain in a vicious cycle as long as mammography, which in the scheme of things is a late-phase screening tool, maintains a chokehold on breast cancer screening protocols in North America. The sanctioned options are few for women grappling with the discomfort and theoretical dangers of breast compression or the cumulative effects of radiation. Insurance companies won’t support the use of alternative screening tools without the endorsement of health regulators. Yet, a non-invasive screening tool, which may reveal the potential for malignant growth 10 years in advance of a lump, won’t earn mainstream acceptance without serious investigation.

* * * *

British philosopher John Stuart Mill believed that free and open discourse was vital to human progress and the only means to finding the “truth.” Even false opinion had its place, he believed, if only as an exercise for reaffirming the validity of one’s beliefs.

In health care, there is no shame in being wrong and no virtue in being right. There is only one expectation: that we have the integrity to weigh and assess each option in a fair and impartial manner. Without such discourse, we will never know the truth.

Thermography: What’s Involved

Thermography is a painless procedure. Before the images are taken, patients must acclimatize to a sub-body-temperature setting, usually between 18 and 22°C. (In some cases, the patient places her hands in cold water as a challenge to the body’s thermal response.) The nervous system, which controls our normal blood flow, reduces the blood circulating to normal tissue. The blood supply of cancer cells, however, is not under autonomic control, which means they appear on the thermographic image as “hotspots.” You’ll stand in front of the camera and have a series of scans taken and these will be interpreted by a board-certified professional. Thermography is not covered by most insurance providers but, as medical procedures go, it is affordable, ranging from $100 to $200 (U.S.) depending on the clinic. Before choosing a clinic, check its credentials.

Doc Defends Pain Supplements, Slams Study

By LAURA GILCREST

The latest government study of a popular dietary supplement combination glucosamine and chondroitin – taken by millions of Americans to relieve osteoarthritis knee pain — which showed no overall benefit in reducing pain, compared to Celebrex and placebo, was fundamentally flawed, and obscured the fact that the supplements do benefit patients with moderate to severe pain, a medical expert said Thursday.

The GAIT (Glucosaminechondroitin Arthritis Intervention Trial), showed that, overall, there was no significant pain reduction in patients taking the supplements alone or in combination, compared to patients taking Pfizer’s COX 2 inhibitor Celebrex and those taking placebo. The six-month research was sponsored by the National Institutes of Health and is the first of two parts, with a second X-ray study still pending.

The findings were published this week in the New England Journal of Medicine, along with an editorial that questioned the supplements’ viability as a treatment option for osteoarthritis patients.

On the basis of the results from GAIT, it seems prudent to tell our patients with symptomatic osteoarthritis of the knee that neither glucosamine hydrochloride nor chondroitin sulfate alone has been shown to be more efficacious than placebo for the treatment of knee pain, the editorial said.

The author added, Furthermore, there is no evidence that these agents prevent osteoarthritis in healthy persons or in persons with knew pain but normal radiographs.

The article also noted that patients with severe knee pain on glucosamine sulfate or chondroitin sulfate could become addicted and that patients should stop taking the supplements if there’s no improvement after three months.

But Jason Theodosakis, an arthritis and sports medicine specialist and author of the book, The Arthritis Cure, attacked the study and the NEJM editorial’s conclusions.

In an interview with United Press International, he also suggested that medical journals like NEJM are beholden to drug companies — whose drug advertising helps support their operations – and thus are more inclined to view studies in the companies’ favor.

The (GAIT study) abstract, when this was first presented, was very positive, and the New England Journal turned it more negative. My concern is that those guys hate (dietary) supplements of any kind, Theodosakis said.

(NEJM) has no ads for supplements, they have ads for Celebrex and Vioxx. I’m very concerned about their bias because all of those people work for the drug companies, said Theodosakis, who said that he does consulting work for drug companies and firms making dietary supplements, but that he has no financial ties to the maker of the particular supplements used in the GAIT study.

UPI did not receive NEJM’s prepared statement in response by press time, but a spokesperson for the journal quoted NEJM’s Editor-In-Chief Jeffrey Drazen that If this person has concerns (about the GAIT study), he should submit them in a letter to the editor.

The NEJM spokesperson explained that the journal reviews letters to the editor and if legitimate concerns about a particular study are raised, it publishes the letter and the study’s authors are given an opportunity to respond.

Regarding the GAIT study, Theodosakis charged that there were multiple flaws in its design, so the findings obscured the fact that, in a single subgroup of patients with moderate to severe pain who were taking the supplements, 79 percent experienced significant pain relief and improved function, compared to Celebrex and placebo, he told UPI.

That’s a huge finding. In patients with high pain, the supplements beat everything, said Theodosakis, who is also a member of the steering oversight committee for the GAIT study.

But despite the study’s design problems, he said, it still had a tremendously significant — highly statistically significant– finding for the combination glucosamine/chondroitin.

What’s more, the study must be put in context with numerous other trials of the supplement duo, Theodosakis said.

The NIH study is just another of 30 human clinical trials done on the supplements, he pointed out. It’s not like this NIH study is the answer, yes or no, it’s just part of the body of literature.

The GAIT study used 14 outcome measures and separated patients into different groups according to pain severity, as is normally done in such trials. However, unfortunately, unlike in most studies, 78 percent of the subjects only had moderate to mild pain, Theodosakis noted. People with more pain have more room for improvement, so when you have a study with patients who are mildly affected, you don’t see a statistically significant difference.

Another problem with the research, he added, was what Theodosakis called diluted data. Specifically, Celebrex did no better than placebo in relieving knee pain in 12 out of the study’s 14 outcome measures, he noted.

Celebrex was being used as a positive control, and it wasn’t positive in most of the outcomes. That’s why we know that the results were diluted and people need to read into the results carefully. Because the comparator failed most of the time, you have to be cautious about your conclusions about the supplements. The most important finding is (the supplements) beat Celebrex in patients who had moderate to severe pain, Theodosakis said.

That shows us that this study understated the results of all of the treatments. That was a bellwether for the study design, he said.

Finally, the study had a very high placebo rate, so that the supplements’ overall pain reduction rate of 68 percent — which would normally look impressive — isn’t considered significant when compared to a placebo rate of 60 percent, he explained.

While a placebo effect of about 35 percent is presumed in most studies, the GAIT study had a placebo rate of 60 percent, partly because the study patients were checked too frequently for treatment compliance. The more interaction you have (with patients), the more likely you are to get a placebo effect, Theodosakis said. Second, because there were so many treatment arms in the study (four treatment groups, and one placebo group) patients knew they had an 80 percent chance of being randomized to a treatment group. They had high expectations, he explained, so these were design flaws.

He said the optimal use of the supplement combination for osteoarthritis knee pain might be to prescribe them in combination with short-term use of a drug like Celebrex, as is typically done in Europe.

Some patients might still need to take a drug intermittently, however, for pain flare-ups, he added.

Theodosakis noted that, in a three-year study of the supplement duo, where patients were followed for eight years, the need for joint replacement was cut by 75 percent. What’s more, the products have not been linked to a single death in 15 years, based on European data, he said.

Theodosakis also criticized the media for its coverage of the GAIT study. I think they just read the conclusion, they don’t read the results, he said. Why did Celebrex fail 12 out of 14 times (in the GAIT study)? That’s incongruent with all of the other Celebrex studies. That should raise a huge red flag that this is an inconclusive study. That should be the headline.
Story from REDORBIT NEWS:
http://www.redorbit.com/news/display/?id=404375

Published: 2006/02/24 00:00:00 CST

© RedOrbit 2005

Move to ban use of Teflon chemical
Clara Pirani, Medical reporter
27jan06

THE US Environmental Protection Agency has moved to stop the production of a chemical used in Teflon and other non-stick coatings, claiming it may cause cancer and reproductive problems.

The EPA has asked eight manufacturers that use a group of chemicals known as perfluorooctanoic acid, or PFOA, to reduce production by 95 per cent by 2010 and to stop using it completely by 2015.

PFOA is used in many products, including non-stick cookware, water-resistant products, microwave popcorn bags, pizza box liners, upholstery and carpets.

The National Toxics Network’s senior adviser Mariann Lloyd-Smith said while there was no monitoring of perfluorochemicals in Australians, PFOA had been found in the blood of many Americans, including pregnant women.

“It’s the most commonly detected chemical of this kind detected in humans, in wildlife, and it’s even been detected in surface water,” Dr Lloyd-Smith said. “In humans it’s been associated with liver damage and long-term reproductive problems. I certainly wouldn’t use a Teflon frypan.”

The US EPA plans to list PFOA alongside other well-known pollutants such as mercury and lead.

“The science on PFOA is still coming in, but the concern is there, so acting now to minimise future releases of PFOA is the right thing to do,” said Susan Hazen, acting assistant administrator of EPA’s Office of Prevention, Pesticides and Toxic Substances. “It’s the right thing to do for our health and our environment.”

DuPont, the only company that manufactures PFOA in the US, has agreed to eliminate releases of the chemical from its manufacturing plants by 2015, but did not commit to completely phasing out its use of the chemical.

Dr Lloyd-Smith said the NTN, a non-government organisation that analyses chemicals and pollutants, would like the chemical banned.

The 8 Top Dietary Mistakes “Healthy Eaters” Make
by www.SixWise.com

Most Americans, 76 percent in fact, believe they have healthy eating habits, according to a 2004 poll by Ipsos-Insight. Yet 57 percent of the nearly 4,000 adults polled also considered themselves overweight. How can this be? Either the healthy eaters aren’t being active enough, or we all have different definitions of “healthy eating.”

“People say they have a healthy diet, but what does that mean to them?” said Ruth Kava of the American Council of Science and Health. “Does it mean they eat an apple a day and the rest of the day eat burgers and french fries?”

Too much fruit juice can leave your diet sugar- and calorie-heavy.

As the poll showed, many people — most of them, at that — believe they are healthy eaters. Meanwhile, a large portion of this same group is struggling with their weight and feeling tired and not in the best of moods — hardly signs that they’re truly eating healthy.

Everyone, even “healthy” eaters, make mistakes. Here are the biggest dietary mistakes that people make (and still think they’re eating healthy).

1. Not eating breakfast (or other meals).
Breakfast is the most important meal of the day, as your body is literally breaking the “fast” you were in overnight. Your body needs nutrients in the morning to get going — and not giving them to it will leave you famished (and prone to overeating or binging on junk food) come lunchtime.

The same goes for skipping other meals — you’re likely to be so hungry that you’ll eat everything you can get your hands on when you come home from work.

2. Drinking lots of fruit juice.
Fruit juice does have some vitamins, however, it also has a lot of sugar and a lot of extra calories. Some of the lower quality brands also contain artificial colors and flavors and added sugar. The healthier choice? Skip the juice and grab a piece of fruit instead.

“What freaks me out is the amount of sugared soda and juice we drink,” says Judith Stern, ScD, RD, professor of nutrition and internal medicine at the University of California, Davis. “I’d like to see all the sugared drinks sent out into space, where they could orbit the Earth forever.”

3. Eating too many “healthy” snacks.
Snacking is fine — healthy, even, if you’re eating fruits, veggies and other nutrient-dense foods. But watch out for those not-so-healthy “health” foods like pretzels, fat-free chips and cookies, and giant bagels.

It’s a lot easier than you think to add an extra 500 calories to your daily intake just by grabbing a handful of this and a handful of that throughout your day.

4. Drinking diet sodas all day.
Many people think that switching from regular to diet soda is a healthy choice. True, you are getting fewer calories and sugar, but diet soda is not good for you. Rather than putting a bunch of artificial sweeteners, flavors and colors (not to mention the caffeine) into your body, you’re much better off with plain water or herbal tea.

5. Overloading the pasta.
Pasta got a bad rap during the “low-carb” craze, but there’s still a large group of people who swear by it. Pasta, particularly the kind made from whole grains (not refined white flour), can be part of a healthy diet. The trick is to eat it in moderation, as the carbs can raise your blood sugar and lead to a surge of insulin in your body otherwise.

The problem is that people often eat up to four cups of pasta at one sitting, when an average serving size is just one cup.

6. Eating a lot of energy bars and drinking sport’s drinks.
Energy bars, though marketed as health foods, are often little more than over-priced candy bars. Some do have added nutrients, but most also have some form of sugar and a lot of calories. Sport’s drinks, similarly, are often loaded with sugar (and artificial flavors and colors) and — unless you’re literally running marathons — you probably don’t need those extra calories.

7. Cutting out all fat from your diet.
All fat is not your enemy. In fact, fat is vital for your body to function properly (or at all). The important thing is to know which fats are healthy and which are not. Fats to definitely avoid include trans fats (found in commercial baked goods, margarine, doughnuts, French fries and other snack foods). The experts are split when it comes to saturated fats, with some saying they should be avoided and others believing they are actually quite healthy.

Even “healthy” frozen dinners can leave you devoid of important nutrients like fiber and antioxidants.

Most everyone agrees that monounsaturated fats, the kind found in avocados, olive oil, and nuts, and omega-3 fats, the kind found in fish, are exceptionally healthy and should definitely be included in your diet.

“If you keep track of total calories, you don’t have to worry about how much fat you eat, just what kind,” said Alice Lichtenstein, DSc, an American Heart Association spokesperson.

8. Focusing your diet on frozen “healthy” dinners.
These meals may give you some vegetables and protein, and certain varieties will help you to stay trim by limiting your portion size (if that’s all you eat), but they are not especially healthy. Many are lacking nutrients and contain preservatives and other unsavory ingredients.

Further, “Eating too many heavily processed foods can leave you short on fiber and antioxidants such as vitamin C,” explains Jo Ann Hattner, RD, clinical dietitian at Stanford University Medical Center.

A healthier option would be to spend a day over the weekend cooking large batches of your favorite meals, then freezing them in convenient portion-sized containers. This way, you’ll have a truly healthy meal that you can grab from the freezer and heat up after work.