February 17, 2009
To the Editor:
Your February 16 article, “Vitamin Pills: A False Hope?” made reference to “high-quality” studies that supported the researchers’ conclusions. Unfortunately, these “high-quality” studies not only have inherent flaws in the methods they utilized, but are creating unwarranted confusion as well.
As noted in the article, “vitamins are essential nutrients that people ingest in their daily diets.” This, however, is actually the most significant flaw in these vitamin studies: in contrast to drug studies, which employ a placebo group, there is no way to isolate the exact cause-and-effect of vitamin supplements without knowing the precise vitamin content of the food the subjects are eating. In fact, most vitamin studies do not monitor the participants’ diets before or during the research period. Without accurate and sound testing methods, the findings are practically meaningless.
There are other flaws in vitamin studies in general: the subject population typically represents a fragment of the general population (such as an older population that is already diagnosed with some type of disease), or the control group is gender-based, or the allotted vitamin dosage is simply too low to yield any type of effect. Ethnic backgrounds are typically ignored, and most of the studies have failed to ensure that the supplements were taken consistently, since most reporting from study participants tends to be anecdotal. These lapses totally undermine the conclusions reached.
Pharmaceutical industry-funded studies inject hysteria and doubt into the discussion of natural health. We believe in a common-sense approach to optimal health: a program of exercise and a balanced diet—one that includes nutritional supplements to correct what is missing because of food processing, soil depletion, and less-than-ideal lifestyle choices.
Very truly yours,
Gretchen DuBeau
Executive Director
American Association for Health Freedom
Wednesday, February 18, 2009
For Immediate Release:
February 17, 2009
Contact:
Tami L. Wahl, Legislative Liaison
800.230.2762
FDA RULING PUTS WOMEN’S HEALTH AT RISK
Health Freedom Organization Urges Action to Lift Estriol Ban
The American Association for Health Freedom (AAHF) is requesting Congressional support to have the FDA-imposed ban on estriol lifted. Estriol is a hormone naturally produced by the body that has been prescribed for decades to address menopausal symptoms.
Last year, the US Food and Drug Administration (FDA) responded to a petition filed by Wyeth Pharmaceuticals asking FDA to change its policy on estriol—claiming, in part, that estriol posed “a serious threat to public health.” FDA ruled that physicians must now obtain an approved investigational new drug (IND) application before pharmacists can fill a prescription with the hormone estriol in compounded medications. According to AAHF, due to the complexity in completing an IND, the FDA has in effect banned the use of estriol.
Today, AAHF hand delivered letters and a White Paper to key political figures in an attempt to force FDA to reverse its policy change on estriol. FDA has already admitted they could not identify a single adverse event from the use of estriol in the decades it has been prescribed to women in the US, and have not yet disclosed any research that would back up its reasoning for designating estriol as a “new investigational drug.”
According to AAHF, the FDA is ignoring the realistic implications of its ruling. Gretchen DuBeau, AAHF’s executive director, stated, “The IND process could cost more than $50,000 and take a minimum of six months to complete. Doctors simply do not have the time, resources, or research expertise to complete this unnecessary, burdensome, and costly procedure to prescribe a natural hormone.”
The public outcry over FDA’s action has been significant. FDA received over 70,000 comments from patients, doctors, and pharmacists in response to Wyeth’s petition, and over 10,000 comments since the ruling.
AAHF Legislative Liaison Tami Wahl said, “Not only has the ruling deprived thousands of women from access to estriol, but two bigger concerns now loom. The first is the impact on the physician-patient relationship. Physicians have the right—and the ethical duty—to practice medicine in a manner that meets a patient’s particular needs. And the right of millions of women to choose their method of healthcare has been significantly compromised. The second concern is that this may be the first of many policies by the FDA to restrict a physician’s ability to prescribe compounded bioidentical hormone replacement therapy (BHRT).
”Senator John Cornyn (R–TX) and Representative Mike Ross (D–AR), along with the support of sixty other members of Congress, introduced a concurrent resolution last session for the FDA to “reverse its policy that aims to eliminate patients’ access to compounded medications containing estriol,” citing physicians as being in the best position to determine which medications are most appropriate for their patients.
Executive Director DuBeau continued, “Pharmacy compounding is a legal, long-standing practice that allows for customized medication to treat a patient’s specific needs. Thousands of women benefit from physician-prescribed bioidentical hormone replacement therapy. For the FDA to issue this ruling without any evidence of adverse effects is a clear indication of abuse and mishandling of the IND process.”
Additional side effects of the ruling include insurers now denying reimbursement for compounded medications containing estriol, and extensive litigation between pharmacies and the FDA questioning FDA’s jurisdiction to issue such a ruling. The 5th and 9th Circuit Courts are now split—frustrating the application of the law—which leaves the legality of compounding in a very precarious situation. The FDA is not the regulatory authority for this traditional pharmacy practice, yet this ruling has the same effect.
AAHF is also investigating the possibility of improper influence in issuing the policy change. A Freedom of Information Act request was submitted to track communication and financial ties between Wyeth and FDA. As Legislative Liaison Tami Wahl pointed out, “Wyeth Pharmaceuticals is a giant drug manufacturer and was the only entity to request that estriol be removed from the market. Wyeth alleged that estriol posed ‘a serious threat to public health’ despite the fact that Wyeth itself markets estriol products in Europe. Perhaps Wyeth’s bottom line from the sale of synthetic hormones was being affected by women’s use of estriol, the natural hormone?”
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net. The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.
February 17, 2009
Contact:
Tami L. Wahl, Legislative Liaison
800.230.2762
FDA RULING PUTS WOMEN’S HEALTH AT RISK
Health Freedom Organization Urges Action to Lift Estriol Ban
The American Association for Health Freedom (AAHF) is requesting Congressional support to have the FDA-imposed ban on estriol lifted. Estriol is a hormone naturally produced by the body that has been prescribed for decades to address menopausal symptoms.
Last year, the US Food and Drug Administration (FDA) responded to a petition filed by Wyeth Pharmaceuticals asking FDA to change its policy on estriol—claiming, in part, that estriol posed “a serious threat to public health.” FDA ruled that physicians must now obtain an approved investigational new drug (IND) application before pharmacists can fill a prescription with the hormone estriol in compounded medications. According to AAHF, due to the complexity in completing an IND, the FDA has in effect banned the use of estriol.
Today, AAHF hand delivered letters and a White Paper to key political figures in an attempt to force FDA to reverse its policy change on estriol. FDA has already admitted they could not identify a single adverse event from the use of estriol in the decades it has been prescribed to women in the US, and have not yet disclosed any research that would back up its reasoning for designating estriol as a “new investigational drug.”
According to AAHF, the FDA is ignoring the realistic implications of its ruling. Gretchen DuBeau, AAHF’s executive director, stated, “The IND process could cost more than $50,000 and take a minimum of six months to complete. Doctors simply do not have the time, resources, or research expertise to complete this unnecessary, burdensome, and costly procedure to prescribe a natural hormone.”
The public outcry over FDA’s action has been significant. FDA received over 70,000 comments from patients, doctors, and pharmacists in response to Wyeth’s petition, and over 10,000 comments since the ruling.
AAHF Legislative Liaison Tami Wahl said, “Not only has the ruling deprived thousands of women from access to estriol, but two bigger concerns now loom. The first is the impact on the physician-patient relationship. Physicians have the right—and the ethical duty—to practice medicine in a manner that meets a patient’s particular needs. And the right of millions of women to choose their method of healthcare has been significantly compromised. The second concern is that this may be the first of many policies by the FDA to restrict a physician’s ability to prescribe compounded bioidentical hormone replacement therapy (BHRT).
”Senator John Cornyn (R–TX) and Representative Mike Ross (D–AR), along with the support of sixty other members of Congress, introduced a concurrent resolution last session for the FDA to “reverse its policy that aims to eliminate patients’ access to compounded medications containing estriol,” citing physicians as being in the best position to determine which medications are most appropriate for their patients.
Executive Director DuBeau continued, “Pharmacy compounding is a legal, long-standing practice that allows for customized medication to treat a patient’s specific needs. Thousands of women benefit from physician-prescribed bioidentical hormone replacement therapy. For the FDA to issue this ruling without any evidence of adverse effects is a clear indication of abuse and mishandling of the IND process.”
Additional side effects of the ruling include insurers now denying reimbursement for compounded medications containing estriol, and extensive litigation between pharmacies and the FDA questioning FDA’s jurisdiction to issue such a ruling. The 5th and 9th Circuit Courts are now split—frustrating the application of the law—which leaves the legality of compounding in a very precarious situation. The FDA is not the regulatory authority for this traditional pharmacy practice, yet this ruling has the same effect.
AAHF is also investigating the possibility of improper influence in issuing the policy change. A Freedom of Information Act request was submitted to track communication and financial ties between Wyeth and FDA. As Legislative Liaison Tami Wahl pointed out, “Wyeth Pharmaceuticals is a giant drug manufacturer and was the only entity to request that estriol be removed from the market. Wyeth alleged that estriol posed ‘a serious threat to public health’ despite the fact that Wyeth itself markets estriol products in Europe. Perhaps Wyeth’s bottom line from the sale of synthetic hormones was being affected by women’s use of estriol, the natural hormone?”
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net. The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.
Friday, February 13, 2009
WOMEN’S MULTIVITAMIN STUDY DANGEROUSLY FLAWED
For Immediate Release:
February 12, 2009
US Contact:
Tami L. Wahl, 800.230.2762
International Contact:
Dr. Robert Verkerk, 44.1306.646.600
Studied Not Representative of General Population;
Study Excluded Dosages Above RDA Guidelines
Today the American Association for Health Freedom (AAHF) criticized a study published by the American Medical Association in the Archives of Internal Medicine (Feb. 9, 2009), which concluded that multivitamin use has little or no influence on the risk of common cancers, cardiovascular disease, or total mortality in postmenopausal women. “This is very, very weak science—if it can be called science at all,” said Gretchen DuBeau, executive director of AAHF.
The Alliance for Natural Health (ANH) also decried the research. Dr. Robert Verkerk, executive and scientific director of ANH, said, “We were astonished to find that, with no reasons given, the study specifically excluded multivitamin and mineral supplements that exceeded the US Recommended Daily Allowances (RDA), which are known to be far too low to yield useful heart disease and cancer protective effects. Also, any multivitamin with fewer than ten nutrients was excluded from the ‘stress supplements’ group, and this would have included some of the highest-dose, limited-combination products that would have been most effective.”
The observational study, led by Dr. Marian Neuhouser of the Fred Hutchinson Cancer Research Center in Seattle, monitored a group of 161,808 postmenopausal women between the ages of 50 and 79 over an eight-year period. The study concluded that there was no difference in disease outcome, whether from cancer or heart disease, for the 42% of women who used multivitamin supplements as for those who did not.
ANH’s medical director, Damien Downing, a medical doctor who has practiced nutritional medicine for twenty-five years, called the research “childish naïveté.” He continued, “The findings could not be applied to the general public because the study involved only less-than-healthy, overweight, postmenopausal women taking trivial amounts of multivitamins and minerals, with no data on their earlier lives when disease causation would have been initiated.”
ANH’s published critique of the study centered on the lack of relevance of the study group to the general population, the doses of supplements used, the frequency of intake, the forms of nutrients taken, and the course of the diseases studied in relation to the time and duration of supplementation.
Gretchen DuBeau pointed out that the vitamin study’s evidence was entirely anecdotal. “The women in the study were not even given identical supplements to take.” And all reporting was left up to the subjects themselves, which is never done in a proper scientific study.”
In response to the sweeping headlines that multivitamin supplements are a waste of time, DuBeau added, “A research project based on such questionable methods—which did not even monitor whether the supplements were natural or synthetic—casts doubt on the entire study and its findings.”
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net.The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant
For Immediate Release:
February 12, 2009
US Contact:
Tami L. Wahl, 800.230.2762
International Contact:
Dr. Robert Verkerk, 44.1306.646.600
Studied Not Representative of General Population;
Study Excluded Dosages Above RDA Guidelines
Today the American Association for Health Freedom (AAHF) criticized a study published by the American Medical Association in the Archives of Internal Medicine (Feb. 9, 2009), which concluded that multivitamin use has little or no influence on the risk of common cancers, cardiovascular disease, or total mortality in postmenopausal women. “This is very, very weak science—if it can be called science at all,” said Gretchen DuBeau, executive director of AAHF.
The Alliance for Natural Health (ANH) also decried the research. Dr. Robert Verkerk, executive and scientific director of ANH, said, “We were astonished to find that, with no reasons given, the study specifically excluded multivitamin and mineral supplements that exceeded the US Recommended Daily Allowances (RDA), which are known to be far too low to yield useful heart disease and cancer protective effects. Also, any multivitamin with fewer than ten nutrients was excluded from the ‘stress supplements’ group, and this would have included some of the highest-dose, limited-combination products that would have been most effective.”
The observational study, led by Dr. Marian Neuhouser of the Fred Hutchinson Cancer Research Center in Seattle, monitored a group of 161,808 postmenopausal women between the ages of 50 and 79 over an eight-year period. The study concluded that there was no difference in disease outcome, whether from cancer or heart disease, for the 42% of women who used multivitamin supplements as for those who did not.
ANH’s medical director, Damien Downing, a medical doctor who has practiced nutritional medicine for twenty-five years, called the research “childish naïveté.” He continued, “The findings could not be applied to the general public because the study involved only less-than-healthy, overweight, postmenopausal women taking trivial amounts of multivitamins and minerals, with no data on their earlier lives when disease causation would have been initiated.”
ANH’s published critique of the study centered on the lack of relevance of the study group to the general population, the doses of supplements used, the frequency of intake, the forms of nutrients taken, and the course of the diseases studied in relation to the time and duration of supplementation.
Gretchen DuBeau pointed out that the vitamin study’s evidence was entirely anecdotal. “The women in the study were not even given identical supplements to take.” And all reporting was left up to the subjects themselves, which is never done in a proper scientific study.”
In response to the sweeping headlines that multivitamin supplements are a waste of time, DuBeau added, “A research project based on such questionable methods—which did not even monitor whether the supplements were natural or synthetic—casts doubt on the entire study and its findings.”
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net.The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant
Friday, February 06, 2009
Children’s Dental Devices Contaminated with BPA
For Immediate Release:
February 6, 2009
Contact:
Gretchen DuBeau, 800-230-2762
American Association for Health Freedom Petitions FDA
Today the American Association for Health Freedom (AAHF) petitioned the FDA about Bisphenol-A (BPA), an organic compound found in polycarbonate plastics. They have asked the FDA to issue a statement encouraging Americans to request BPA-free dental sealants and devices for their children until studies prove conclusively that BPA presents no health risks.
The petition also asks the BPA Task Force to study the risks to children from exposure to BPA not only through dental applications specifically, but also through food, food containers, water, the environment, or any other means cumulatively. The BPA Task Force is an agency-wide task force created by the FDA last year to facilitate cross-agency review of all FDA-regulated products containing BPA.
There have been a significant number of reports about potential health risks from exposure to BPA—diabetes and cardiovascular disease in particular. This exposure can come though many different sources—food, the environment, food containers, baby bottles, dental applications, and medical devices, to name a few.
Canada is moving forward with legislation that bans the importation, sale, and advertising of polycarbonate baby bottles, and has issued a health warning to its citizens not to use any product containing BPA if it is to be heated or warmed. Health Canada proposed classifying the chemical as “toxic to human health and the environment.” Here in the U.S., a panel convened by the National Institutes of Health determined that there is clear evidence for concern about BPA’s effects on fetal and infant brain development and behavior. In addition, there are concerns that BPA could interfere with the sexual development of children.
In her statement released today, Gretchen DuBeau, AAHF’s executive director, said, “BPA is a known toxic substance. With safe alternatives on the market, parents need to be aware that BPA-free dental applications are available for their children.”
Despite the actions of other world governments in banning BPA, the FDA is standing by their position that “FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects” (FDA, Alderson Statement to US Senate, 5-14-08). According to AAHF, however, the FDA’s findings are to a large extent based on the chemical industry’s own studies, and ignores numerous independent scientific research findings.
The BPA Task Force is currently reviewing additional research studies to determine what level of exposure to BPA creates a health risk; however, a public release date for any new findings has not been set.
“At this juncture,” DuBeau added, “with known links between exposure to BPA and adverse health effects, common sense dictates that we should proceed cautiously and request BPA-free dental applications. These products exist and are readily available on the market.”
The FDA Petition is available at:
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net
The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.
February 6, 2009
Contact:
Gretchen DuBeau, 800-230-2762
American Association for Health Freedom Petitions FDA
Today the American Association for Health Freedom (AAHF) petitioned the FDA about Bisphenol-A (BPA), an organic compound found in polycarbonate plastics. They have asked the FDA to issue a statement encouraging Americans to request BPA-free dental sealants and devices for their children until studies prove conclusively that BPA presents no health risks.
The petition also asks the BPA Task Force to study the risks to children from exposure to BPA not only through dental applications specifically, but also through food, food containers, water, the environment, or any other means cumulatively. The BPA Task Force is an agency-wide task force created by the FDA last year to facilitate cross-agency review of all FDA-regulated products containing BPA.
There have been a significant number of reports about potential health risks from exposure to BPA—diabetes and cardiovascular disease in particular. This exposure can come though many different sources—food, the environment, food containers, baby bottles, dental applications, and medical devices, to name a few.
Canada is moving forward with legislation that bans the importation, sale, and advertising of polycarbonate baby bottles, and has issued a health warning to its citizens not to use any product containing BPA if it is to be heated or warmed. Health Canada proposed classifying the chemical as “toxic to human health and the environment.” Here in the U.S., a panel convened by the National Institutes of Health determined that there is clear evidence for concern about BPA’s effects on fetal and infant brain development and behavior. In addition, there are concerns that BPA could interfere with the sexual development of children.
In her statement released today, Gretchen DuBeau, AAHF’s executive director, said, “BPA is a known toxic substance. With safe alternatives on the market, parents need to be aware that BPA-free dental applications are available for their children.”
Despite the actions of other world governments in banning BPA, the FDA is standing by their position that “FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects” (FDA, Alderson Statement to US Senate, 5-14-08). According to AAHF, however, the FDA’s findings are to a large extent based on the chemical industry’s own studies, and ignores numerous independent scientific research findings.
The BPA Task Force is currently reviewing additional research studies to determine what level of exposure to BPA creates a health risk; however, a public release date for any new findings has not been set.
“At this juncture,” DuBeau added, “with known links between exposure to BPA and adverse health effects, common sense dictates that we should proceed cautiously and request BPA-free dental applications. These products exist and are readily available on the market.”
The FDA Petition is available at:
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net
The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.
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