Sorry God... You're Not FDA Approved
Tuesday, November 17, 2009
How do you define a valuable healthcare intervention? I believe we would all agree at the top of the list is “safe and effective.” But there is another essential quality inherent in a valuable intervention that may not immediately come to mind… Accessibility.
The Food and Drug Administration (FDA) was established in 1906 to regulate medications and food products in the United States. The FDA’s goal is to protect the people by controlling access and deciding what food and which pharmaceuticals reach the marketplace. What about substances that naturally occur in nature but are not classified as food? Can natural substances that have been studied and have known beneficial effects in maintaining and regaining health be FDA approved? Yes, they can. But these remedies found in nature cannot be patented. Since one cannot patent a natural substance, and because the FDA processes is so costly, these natural products cannot be sold for exorbitant profits. It is cost and profit prohibitive to seek approval by the FDA for a natural occurring substance.
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Regulators (the FDA) usually don't negotiate their budgets with the industries they oversee (pharmaceutical companies)," writes Anna Wilde Mathews, but the U.S. Food and Drug Administration does. In the early 1990s, drug companies started paying the FDA millions of dollars in user fees, to speed the drug approval process. The fees "now fund more than half the agency's critical drug-review process."
This review process excludes, of course, the natural occurring substances that cannot be patented.
One of the results of the situation explained above is the Dietary Supplement Health and Education Act of 1994 (DSHEA). This statute states, “A dietary supplement may not claim to treat, cure, or prevent any disease.” Since your physician is in the business of treating, curing, and preventing disease this verbiage may very well prevent him/her from readily recommending natural supplements. You may leave their office with a prescription for a pharmaceutical your insurance company will likely cover, but regarding natural remedies you are usually on your own to dig up the information and always on your own to pay for them.
Why is all this important? Access.
In the United States, we have what is termed “conventional medicine” or pharmaceuticals, and what is termed “alternative medicine” or natural occurring remedies. The American College of Rheumatology cautions against the use of “natural” remedies because they are “not based on the quality of scientific evidence required by the Food and Drug Administration (FDA) for approval of conventional medication.” They go on to discuss the “dangers and side effects” of well researched and documented supplements such as chondroitin, glucosamine, SAMe, and fish oils. Their bottom line position is, “Because the FDA is currently unable to regulate the quality of herbal remedies and supplements, or verify their effectiveness or safety, the use of herbal remedies is not recommended.”
Bioidentical hormones are another interesting topic. Bioidentical hormones, as the name suggests, are identical to those produced by the human body. They are prescribed by a medical doctor, compounded using the same FDA and USP registered materials the pharmaceutical companies utilize, and prepared by qualified pharmacists under the oversight of their professional board. A number of pharmaceutical companies manufacture synthetic versions which are patentable, while putting significant pressure on the FDA to crack down on compounding pharmacists.
USA Today reported, “Wyeth, which makes two of the most commonly used brand-name hormone therapies, Prempro and Premarin, asked the FDA in 2005 to take action against compounders making similar but natural products.” The FDA did just that.
In an AP report this month, Zetia and Vytorin, two drugs manufactured by Merck taken by millions of Americans for years to lower cholesterol, still have not shown improved clinical outcomes. Yet, in a new study, AP reported, “Zetia failed to shrink buildups in artery walls while a new rival drug, Niaspan, did so significantly.” What is Niaspan? Niaspan is a slow-release version of niacin. Niacin is a natural occurring B vitamin. Of course Niaspan, manufactured by Abbott Labs, had to have a unique time released delivery method in order to be patented, and profitable, and FDA approved.
The other day I found best-selling author and well-respected physician Andrew Weil on the FDA H1N1 fraud list for recommending researched and holistic options to guard against the likelihood of catching the flu and/or decreasing the severity of its symptoms. God forbid that kind of information gets out – may lose another vaccine sale on an otherwise healthy young adult. Below is a statement from a former chief virologist at the FDA.
Dr. Anthony Morris, a distinguished virologist and former Chief Vaccine Officer at the U.S. Federal Drug Administration (FDA), states that, “There is no evidence that any influenza vaccine thus far developed is effective in preventing or mitigating any attack of influenza.” He adds, "The producers of these vaccines know they are worthless, but they go on selling them anyway.”
I highly recommend a New York Review of Books article by Marcia Angell. In this article titled, “Drug Companies and Doctors: A Story of Corruption,” she lays out the extensive financial ties between pharmaceutical companies and many physicians who conduct clinical trial research. Most disturbing was the corruption of senior faculty at prestigious medical schools around the country. These “key opinion leaders” are the faculty and professionals teaching our next generation of physicians.
Ms Angell states, “It is simply no longer possible to believe much of the clinical research that is published, or rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
Wow. So, I am no editor for the New England Journal of Medicine, but allow me to share a story closer to my heart.
During my husband’s OB/Gyn internship at Brackenridge Hospital back in 1988, he was instructed by his attending physicians to prescribe a drug called Parlodel to hundreds of new young mothers. This drug, also known as bromocriptine mesilate, works by stimulating dopamine receptors in the brain. This stimulation in turn decreases the production of prolactin from the pituitary gland. The drug has many uses including movement disorder management in Parkinson’s patients, but the doctors in 1988 were prescribing it to stop milk production in these new moms. This was the standard of care so the “superior” and more expensive formula, Enfamil, could be provided to these welfare moms and given to nourish their newborns instead of that nasty, natural, and substandard breast milk.
Are you kidding me?!?
The drug was pulled from this application after a number of heart attacks, strokes, seizures, and deaths resulted. This is a true story outlining the standard thinking a short 20 years ago which my brilliant, free-thinking, and holistic physician-husband allowed me to share with you. The point is clear. We do not have all the information, and many times we are trying to improve on mother-nature when it is simply and totally inappropriate.
We need safe, effective, accessibly, and affordable options for health management in the United States. I believe this is an area of healthcare that requires significant reform.
This is my question.
How did patentable, synthetic, and altered chemicals become “conventional” medicine and the attempt to regulate the health of God’s design with natural substances He created become “alternative” medicine?
I am sorry God, you’re not FDA approved.
I would love your thoughts on this one.
Michele
www.SourceWatch.org
www.healthfreedomusa.org
http://www.lifespirit.org/Alternative-Practices.htm
http://www.rheumatology.org/public/factsheets/diseases_and_conditions/herbal.asp
Why The FDA Suppresses Natural Remedies and Cures www.ezinearticle.com
www.mercola.com Nov. 17, 2009 post.
Wall Street Journal (sub req'd), September 1, 2006http://news.yahoo.com/s/ap/20091116/ap_on_he_me/us_med_cholesterol_drugs
http://www.nybooks.com/articles/22237
www.nvic.org/
www.overdosedamerica.com
www.ourdailymedsthebook.com/
The Food and Drug Administration (FDA) was established in 1906 to regulate medications and food products in the United States. The FDA’s goal is to protect the people by controlling access and deciding what food and which pharmaceuticals reach the marketplace. What about substances that naturally occur in nature but are not classified as food? Can natural substances that have been studied and have known beneficial effects in maintaining and regaining health be FDA approved? Yes, they can. But these remedies found in nature cannot be patented. Since one cannot patent a natural substance, and because the FDA processes is so costly, these natural products cannot be sold for exorbitant profits. It is cost and profit prohibitive to seek approval by the FDA for a natural occurring substance.
"
This review process excludes, of course, the natural occurring substances that cannot be patented.
One of the results of the situation explained above is the Dietary Supplement Health and Education Act of 1994 (DSHEA). This statute states, “A dietary supplement may not claim to treat, cure, or prevent any disease.” Since your physician is in the business of treating, curing, and preventing disease this verbiage may very well prevent him/her from readily recommending natural supplements. You may leave their office with a prescription for a pharmaceutical your insurance company will likely cover, but regarding natural remedies you are usually on your own to dig up the information and always on your own to pay for them.
Why is all this important? Access.
Bioidentical hormones are another interesting topic. Bioidentical hormones, as the name suggests, are identical to those produced by the human body. They are prescribed by a medical doctor, compounded using the same FDA and USP registered materials the pharmaceutical companies utilize, and prepared by qualified pharmacists under the oversight of their professional board. A number of pharmaceutical companies manufacture synthetic versions which are patentable, while putting significant pressure on the FDA to crack down on compounding pharmacists.
USA Today reported, “Wyeth, which makes two of the most commonly used brand-name hormone therapies, Prempro and Premarin, asked the FDA in 2005 to take action against compounders making similar but natural products.” The FDA did just that.
In an AP report this month, Zetia and Vytorin, two drugs manufactured by Merck taken by millions of Americans for years to lower cholesterol, still have not shown improved clinical outcomes. Yet, in a new study, AP reported, “Zetia failed to shrink buildups in artery walls while a new rival drug, Niaspan, did so significantly.” What is Niaspan? Niaspan is a slow-release version of niacin. Niacin is a natural occurring B vitamin. Of course Niaspan, manufactured by Abbott Labs, had to have a unique time released delivery method in order to be patented, and profitable, and FDA approved.
The other day I found best-selling author and well-respected physician Andrew Weil on the FDA H1N1 fraud list for recommending researched and holistic options to guard against the likelihood of catching the flu and/or decreasing the severity of its symptoms. God forbid that kind of information gets out – may lose another vaccine sale on an otherwise healthy young adult. Below is a statement from a former chief virologist at the FDA.
Dr. Anthony Morris, a distinguished virologist and former Chief Vaccine Officer at the U.S. Federal Drug Administration (FDA), states that, “There is no evidence that any influenza vaccine thus far developed is effective in preventing or mitigating any attack of influenza.” He adds, "The producers of these vaccines know they are worthless, but they go on selling them anyway.”
I highly recommend a New York Review of Books article by Marcia Angell. In this article titled, “Drug Companies and Doctors: A Story of Corruption,” she lays out the extensive financial ties between pharmaceutical companies and many physicians who conduct clinical trial research. Most disturbing was the corruption of senior faculty at prestigious medical schools around the country. These “key opinion leaders” are the faculty and professionals teaching our next generation of physicians.
Ms Angell states, “It is simply no longer possible to believe much of the clinical research that is published, or rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
Wow. So, I am no editor for the New England Journal of Medicine, but allow me to share a story closer to my heart.
Are you kidding me?!?
The drug was pulled from this application after a number of heart attacks, strokes, seizures, and deaths resulted. This is a true story outlining the standard thinking a short 20 years ago which my brilliant, free-thinking, and holistic physician-husband allowed me to share with you. The point is clear. We do not have all the information, and many times we are trying to improve on mother-nature when it is simply and totally inappropriate.
We need safe, effective, accessibly, and affordable options for health management in the United States. I believe this is an area of healthcare that requires significant reform.
This is my question.
How did patentable, synthetic, and altered chemicals become “conventional” medicine and the attempt to regulate the health of God’s design with natural substances He created become “alternative” medicine?
I am sorry God, you’re not FDA approved.
I would love your thoughts on this one.
Michele
www.SourceWatch.org
www.healthfreedomusa.org
http://www.lifespirit.org/Alternative-Practices.htm
http://www.rheumatology.org/public/factsheets/diseases_and_conditions/herbal.asp
Why The FDA Suppresses Natural Remedies and Cures www.ezinearticle.com
www.mercola.com Nov. 17, 2009 post.
Wall Street Journal (sub req'd), September 1, 2006http://news.yahoo.com/s/ap/20091116/ap_on_he_me/us_med_cholesterol_drugs
http://www.nybooks.com/articles/22237
www.nvic.org/
www.overdosedamerica.com
www.ourdailymedsthebook.com/
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