Risks vs. Benefits
The public consciousness of risk vs. benefit was raised considerably with the media’s discussion of the benefits of taking a Cox II inhibitor (Celebrex and Vioxx) vs. the potential risks (Cox II inhibitors are linked to the risk of gastrointestinal bleeding as well to an increased risk of heart attack).
That consciousness raising continued in the days between October 13 and October 18, when the following were mentioned in the media:
60 percent of those with Alzheimer’s disease are prescribed antipsychotic medication. In the United Kingdom alone, the annual cost of these drugs is 80 million pounds. But in 2006, a 42-center U.S. trial found no significant differences between the placebo and the antipsychotic medications after 12 weeks.
French scientists analyzed 19,000 patients with inflammatory bowel disease. The patients who took immune-inhibiting drugs (thiopurines such as Imuran) were more than five times as likely to develop lymphoma than those who had never received the drugs.
Gardasil vaccine is suspected as the cause of ALS/Lou Gehrig’s disease in two young women. According to the 8/18/09 issue of the Toronto Globe and Mail, 23 million doses of the HPV vaccine have been administered to young women in the United States, resulting in 32 deaths, 12,424 reported adverse reactions and 772 reported severe reactions (blood clots, pancreatic failure, motor neuron disease and anaphylaxis).
An analysis by the National Trauma Databank has highlighted that the rate of warfarin/blood thinner use has increased significantly: from 7.3 percent in 2002 to nearly 13 percent in 2006. Warfarin use was associated with a 30 percent increase in risk of death among trauma patients and a 20 percent increased risk in those aged 65 and older. And according to the Canadian Medical Journal, the rate of heparin-induced lesions is four times what was officially reported.
An analysis of 1998-2005 Medicare data has shown that patients with new lower-back pain were more likely to have surgery if they were treated in an area that had a higher-than-average concentration of MRI machines — even though, according to previous research, increased back surgery has not produced improved outcomes for patients. The Wall Street Journal had earlier reported that Pittsburgh has more MRI scanners than all of Canada.
Research published in the October 2009 Chest reviewed the current guidelines for using an inhaled steroid along with a long-acting beta agonist for COPD. Researchers found the benefit of the two-drug approach was limited and accompanied by substantial risks of pneumonia and other infections.
The FDA has announced plans to work with the National Eye Institute and the Department of Defense to review LASIK eye surgery. Of the approximately 6 million Americans who have undergone the surgery, which permanently reshapes the cornea, 5 percent are dissatisfied with the results. The long-term safety of the surgery is unknown. There have been reports of permanent damages to the eyes following surgery, including double vision, dry eye and halos around objects at night. Letters citing inadequate reporting of adverse events were sent to 17 LASIK eye surgery centers.
It is staggering to think these seven examples are drawn from only one week of media coverage. When we consider the number of prescription drugs used daily in American medicine, as well as the number of surgical and scanning procedures, it becomes clear we have little appreciation for the risks of prescription drugs and medical procedures. To address America’s healthcare costs in a meaningful fashion, the risks as well as the benefits of a therapy must be considered.
Tuesday, October 27, 2009
47 Members of Congress Support Consumers’ Right to Choose Their Health Practitioners
47 Members of Congress Support Consumers’ Right to Choose Their Health Practitioners
The legislators have sent House Speaker Nancy Pelosi, D-Calif., a letter proposing a ban on discrimination against integrative MDs, DOs, chiropractors and other well-trained and credentialed healthcare providers who have not previously been discriminated against under federal law. If discrimination is not forbidden, conventional licensed practitioners will try to use federal law, as they have used state law, to restrict competition from alternative and integrative sources.
The letter, dated September 14, 2009, urged that any healthcare reform legislation passed include "a provider non-discrimination provision at the federal level, and make it applicable to all plans." Although the letter does not mention any particular healthcare disciplines, it was supported by the American Chiropractic Association. The association notes that "while ACA remains focused on many chiropractic-specific legislative initiatives, there are certainly some areas where the profession shares concerns with a larger body of health care providers.” Rep. Bruce Braley, D-Iowa, and Rep. Martin Heinrich, D-N.M., led the drafting of the letter, which focuses on the importance of patients’ being able to choose the type of healthcare provider who will treat them. It also stresses the need to prevent insurance plans from discriminating against entire classes of healthcare providers. A third focus is on maintaining any hard-won rights providers have gained at the state level.
The legislators have sent House Speaker Nancy Pelosi, D-Calif., a letter proposing a ban on discrimination against integrative MDs, DOs, chiropractors and other well-trained and credentialed healthcare providers who have not previously been discriminated against under federal law. If discrimination is not forbidden, conventional licensed practitioners will try to use federal law, as they have used state law, to restrict competition from alternative and integrative sources.
The letter, dated September 14, 2009, urged that any healthcare reform legislation passed include "a provider non-discrimination provision at the federal level, and make it applicable to all plans." Although the letter does not mention any particular healthcare disciplines, it was supported by the American Chiropractic Association. The association notes that "while ACA remains focused on many chiropractic-specific legislative initiatives, there are certainly some areas where the profession shares concerns with a larger body of health care providers.” Rep. Bruce Braley, D-Iowa, and Rep. Martin Heinrich, D-N.M., led the drafting of the letter, which focuses on the importance of patients’ being able to choose the type of healthcare provider who will treat them. It also stresses the need to prevent insurance plans from discriminating against entire classes of healthcare providers. A third focus is on maintaining any hard-won rights providers have gained at the state level.
Do mandatory vaccinations achieve higher rates of immunization?
Tami Wahl, ANH-USA’s legislative director, attended the 4th International Public Conference on Vaccination, held in Reston, Va., October 2-4, 2009. The conference was hosted by the National Vaccine Information Center, a nonprofit educational organization founded in 1982. The oldest and largest consumer organization advocating for the institution of vaccine safety and the protection of informed consent in the mass-vaccination system, NVIC is an independent clearinghouse for information. Consequently, it does not promote the use of vaccines; nor does it advise against their use. Rather, it supports the availability of all preventive healthcare options, including vaccination, and the right of consumers to make educated, voluntary healthcare choices. NVIC’s work aims to ensure that public-health policies are based in science and not influenced by industry.
At the conference, hundreds of parents, grandparents, health practitioners, medical doctors, former pharmaceutical sales representatives, concerned citizens, community activists and members of the media heard a variety of noted speakers. The topics covered included the history of vaccination, the status of the H1N1 and HPV/Gardasil vaccines, legal matters (including manufacturer liability), constitutional law (including protections against mandatory vaccination), informed consent, pet vaccination, homeopathy and immunization. There were also sessions that allowed for interaction with the speakers.
An especially compelling presentation compared how Japan and the United States handle vaccinations. For example, Japan completes vaccinations for infants over an extended period of time (as opposed to the tight “schedule” implemented in the United States) and does not vaccinate infants under 3 months of age. Since 1994, Japan has utilized a “voluntary vaccination” plan and found it to be highly effective. In short, mandatory vaccinations don’t always mean higher rates of true immunization. The Japanese government has pulled certain vaccines from the schedule when these were deemed unnecessary or not completely safe. As a result, the Japanese have a high degree of trust in their vaccine schedule.
The conference also addressed the problem of studies that fail to compare a tested vaccine with a true placebo control-group. Often, the placebo contains mercury or some other toxic substance. Sometimes another vaccine is used in the control group in lieu of a true placebo.
Several speakers gave pointers for individuals who want to get involved at the local level: 1) Become informed about the side effects of vaccines; 2) be familiar with your state’s laws (e.g., is a religious exemption available?); 3) educate others, such as legislators and family members (www.nvic.org).
On a related note, a New York state Supreme Court judge has granted a temporary restraining order against the requirement that all healthcare workers get the H1N1 vaccine. The restraining order, granted October 19, 2009, will be in effect until New York’s Supreme Court reviews the case in a hearing scheduled for October 30. The original order indicated that workers not vaccinated against seasonal flu and the H1N1 virus would be subject to disciplinary action after November 30. A 1990 court ruling rejected healthcare workers’ opposition to mandatory rubella vaccination.
At the conference, hundreds of parents, grandparents, health practitioners, medical doctors, former pharmaceutical sales representatives, concerned citizens, community activists and members of the media heard a variety of noted speakers. The topics covered included the history of vaccination, the status of the H1N1 and HPV/Gardasil vaccines, legal matters (including manufacturer liability), constitutional law (including protections against mandatory vaccination), informed consent, pet vaccination, homeopathy and immunization. There were also sessions that allowed for interaction with the speakers.
An especially compelling presentation compared how Japan and the United States handle vaccinations. For example, Japan completes vaccinations for infants over an extended period of time (as opposed to the tight “schedule” implemented in the United States) and does not vaccinate infants under 3 months of age. Since 1994, Japan has utilized a “voluntary vaccination” plan and found it to be highly effective. In short, mandatory vaccinations don’t always mean higher rates of true immunization. The Japanese government has pulled certain vaccines from the schedule when these were deemed unnecessary or not completely safe. As a result, the Japanese have a high degree of trust in their vaccine schedule.
The conference also addressed the problem of studies that fail to compare a tested vaccine with a true placebo control-group. Often, the placebo contains mercury or some other toxic substance. Sometimes another vaccine is used in the control group in lieu of a true placebo.
Several speakers gave pointers for individuals who want to get involved at the local level: 1) Become informed about the side effects of vaccines; 2) be familiar with your state’s laws (e.g., is a religious exemption available?); 3) educate others, such as legislators and family members (www.nvic.org).
On a related note, a New York state Supreme Court judge has granted a temporary restraining order against the requirement that all healthcare workers get the H1N1 vaccine. The restraining order, granted October 19, 2009, will be in effect until New York’s Supreme Court reviews the case in a hearing scheduled for October 30. The original order indicated that workers not vaccinated against seasonal flu and the H1N1 virus would be subject to disciplinary action after November 30. A 1990 court ruling rejected healthcare workers’ opposition to mandatory rubella vaccination.
Does the Safeway Amendment address workplace wellness in a financially responsible manner?
As the debate for healthcare reform continues inside the beltway, on the airwaves, and around many a dinner table and water cooler, how can we — a nation known for ingenuity and entrepreneurship — deliver quality care for a reasonable price? Former House Speaker Newt Gingrich, in his book Saving Lives, Saving Money, is but one voice suggesting that America could do much better. Princeton economist Professor Ute Reinhardt has also condemned our current system for wasting money, doing little to create wellness and all-too-frequently serving vested interests rather than patients’ health.
Business journals and newspapers, including The Wall Street Journal, have charted the impact of America’s rising healthcare costs on the nation’s industrial competitiveness. In his 1986 book America’s Health Care Revolution: Who Lives? Who Dies? former Secretary of Health, Education and Welfare Joseph Califano Jr., revealed that Chrysler was spending more on healthcare (Califano called it “sick care”) than on steel for its automobiles. Whole Foods CEO John Mackey and Safeway CEO Steve Burd have published editorials in The Wall Street Journal about their commitment to a financially responsible approach to employees’ health. Given the $1.7 trillion deficit, many of us wonder if the concept of financially responsible healthcare reform resonates with our elected officials.
The fall 2009 issue of The American Acupuncturist included an article, “Evaluation in Acupuncture: Past and Future,” by a team of authors led by New York acupuncturist Michael Jabbour, LAc, MS. Jabbour had examined the literature for all studies of acupuncture that focus on costs. A key thrust of his article was to give a monetary value to "quality of life years" gained by the use of acupuncture. The authors, who noted the importance of including "indirect costs and intangible costs" in economic studies, concluded that "acupuncture has the capacity to offer cost-effective treatment, even when compared to conventional medicine”.
Economist and researcher Patricia Herman, ND, MS, Ph.D., published “Herman's Systematic Review Yields Top 9 Therapies/21 Conditions with High Quality Evidence of Cost Savings from CAM” in the August 27, 2009, issue of The Integrator. Herman noted that the most intriguing finding by the studies she has so far been able to evaluate is that "over 50% show cost savings." She underscores that "this is beyond cost-effectiveness to cost-savings," adding that "this is not likely just an artifact of publication bias because there is no disincentive for publishing something as cost-effective vs. cost saving." Herman notes that this is particularly interesting given "the typical conventional point of view that CAM increases cost."
Both the Safeway amendment from the Senate Finance Committee and HR 3200 (America’s Affordable Health Choices Act) address workplace wellness, including incentives for participation in voluntary wellness programs. Existing HIPAA legislation permits insurance premium discounts of up to 20 percent when an individual meets wellness program criteria. For example, the current Safeway wellness program requires employees to meet healthy weight, blood pressure, and cholesterol benchmarks and requires that they not smoke. If the individual fails to meet these criteria, premiums may be raised by 20 percent. The Safeway amendment increases the discount limits to between 30 percent and 50 percent. A group of 65 industry organizations have recently written a letter to Congress stating, “We believe that allowing employers to vary premiums by up to 50 percent of the total cost of employee coverage could lead to discriminatory practices and make health coverage unaffordable for those who need it the most.” However, the current model, which leads to a mentality of “Bill my insurance,” has done little to encourage individuals covered by employer-paid plans to control their own healthcare costs. It is true that the insurance discount must be carefully managed to avoid employer violation of employee privacy. Employers should not have access to an employee’s blood pressure numbers. But rewarding healthy lifestyle choices can be done without invading privacy. And of course in the long run people shouldn’t have to look to their employer as the only source of tax favored health insurance.
According to economist Dr. Ute Reinhardt, the wage controls during World War II, which inspired the current system of employer-paid health insurance, with its tax benefits solely for businesses, is unsustainable. Individual responsibility and freedom of choice have driven America’s use of integrative medicine. More importantly, integrative medicine is effective and costs less than disease care. This approach also protects the privacy of medical records.
Business journals and newspapers, including The Wall Street Journal, have charted the impact of America’s rising healthcare costs on the nation’s industrial competitiveness. In his 1986 book America’s Health Care Revolution: Who Lives? Who Dies? former Secretary of Health, Education and Welfare Joseph Califano Jr., revealed that Chrysler was spending more on healthcare (Califano called it “sick care”) than on steel for its automobiles. Whole Foods CEO John Mackey and Safeway CEO Steve Burd have published editorials in The Wall Street Journal about their commitment to a financially responsible approach to employees’ health. Given the $1.7 trillion deficit, many of us wonder if the concept of financially responsible healthcare reform resonates with our elected officials.
The fall 2009 issue of The American Acupuncturist included an article, “Evaluation in Acupuncture: Past and Future,” by a team of authors led by New York acupuncturist Michael Jabbour, LAc, MS. Jabbour had examined the literature for all studies of acupuncture that focus on costs. A key thrust of his article was to give a monetary value to "quality of life years" gained by the use of acupuncture. The authors, who noted the importance of including "indirect costs and intangible costs" in economic studies, concluded that "acupuncture has the capacity to offer cost-effective treatment, even when compared to conventional medicine”.
Economist and researcher Patricia Herman, ND, MS, Ph.D., published “Herman's Systematic Review Yields Top 9 Therapies/21 Conditions with High Quality Evidence of Cost Savings from CAM” in the August 27, 2009, issue of The Integrator. Herman noted that the most intriguing finding by the studies she has so far been able to evaluate is that "over 50% show cost savings." She underscores that "this is beyond cost-effectiveness to cost-savings," adding that "this is not likely just an artifact of publication bias because there is no disincentive for publishing something as cost-effective vs. cost saving." Herman notes that this is particularly interesting given "the typical conventional point of view that CAM increases cost."
Both the Safeway amendment from the Senate Finance Committee and HR 3200 (America’s Affordable Health Choices Act) address workplace wellness, including incentives for participation in voluntary wellness programs. Existing HIPAA legislation permits insurance premium discounts of up to 20 percent when an individual meets wellness program criteria. For example, the current Safeway wellness program requires employees to meet healthy weight, blood pressure, and cholesterol benchmarks and requires that they not smoke. If the individual fails to meet these criteria, premiums may be raised by 20 percent. The Safeway amendment increases the discount limits to between 30 percent and 50 percent. A group of 65 industry organizations have recently written a letter to Congress stating, “We believe that allowing employers to vary premiums by up to 50 percent of the total cost of employee coverage could lead to discriminatory practices and make health coverage unaffordable for those who need it the most.” However, the current model, which leads to a mentality of “Bill my insurance,” has done little to encourage individuals covered by employer-paid plans to control their own healthcare costs. It is true that the insurance discount must be carefully managed to avoid employer violation of employee privacy. Employers should not have access to an employee’s blood pressure numbers. But rewarding healthy lifestyle choices can be done without invading privacy. And of course in the long run people shouldn’t have to look to their employer as the only source of tax favored health insurance.
According to economist Dr. Ute Reinhardt, the wage controls during World War II, which inspired the current system of employer-paid health insurance, with its tax benefits solely for businesses, is unsustainable. Individual responsibility and freedom of choice have driven America’s use of integrative medicine. More importantly, integrative medicine is effective and costs less than disease care. This approach also protects the privacy of medical records.
Thursday, October 15, 2009
New studies find that most men aren’t told about the benefits and risks of PSA screening.
Two new studies published in the Sept. 25, 2009, online edition of BMJ —one by Benny Holmstrom, a urologist with Gavle Hospital in Gavle, Sweden; the other by Jennifer Stark, a research fellow at Harvard School of Public Health in Boston — highlight once again the lack of patient education regarding the risks associated with prostate cancer screening using the PSA blood test. According to Dr. Michael Pignone of the University of North Carolina at Chapel Hill, the chance of dying from prostate cancer for American men is 1 in 1,000. The chance of dying from heart disease, cancer or other causes is 113 in 1,000.
The British National Health Service first sounded the alarm two decades ago, declaring that routine PSA screening was costly, did not help men live longer or live better, and also subjected men to the risks of over-diagnosis and treatment for false-positive test results. Stanford University followed suit in 1987, calling PSA screening clinically useless. This year Harvard weighed in as well. In his 2004 book Should I Be Tested for Cancer, Maybe Not and Here’s Why, Gilbert Welch, M.D., professor of medicine at Dartmouth University, alerted readers to the lack of science validating routine PSA screening. Mass screening wastes money while endangering men’s quality of life. Targeted screening for men at high genetic risk, or for those with lifestyle risks, was suggested as a much more sound choice both medically and economically.
The two new studies point out that when a positive PSA test leads to a prostate biopsy, 75 percent of the time there is no cancer present. While men screened for prostate cancer are 2 to 4 times more likely to be diagnosed, the death rate from prostate cancer is the same for those screened as for those not screened. For men treated aggressively, the risks of consequent impotence and incontinence threaten quality of life.
Healthcare Reform as it presently exists won’t change the fact that the medical profession takes decades to abandon its harmful and wasteful practices. It’s long been medicine’s inside joke that it takes a generation of physicians to be trained, practice and die before meaningful change occurs. The American Cancer Society says it expects to alter its PSA recommendations next year. But why wait? When is the U.S. system of healthcare going to wake up?
The British National Health Service first sounded the alarm two decades ago, declaring that routine PSA screening was costly, did not help men live longer or live better, and also subjected men to the risks of over-diagnosis and treatment for false-positive test results. Stanford University followed suit in 1987, calling PSA screening clinically useless. This year Harvard weighed in as well. In his 2004 book Should I Be Tested for Cancer, Maybe Not and Here’s Why, Gilbert Welch, M.D., professor of medicine at Dartmouth University, alerted readers to the lack of science validating routine PSA screening. Mass screening wastes money while endangering men’s quality of life. Targeted screening for men at high genetic risk, or for those with lifestyle risks, was suggested as a much more sound choice both medically and economically.
The two new studies point out that when a positive PSA test leads to a prostate biopsy, 75 percent of the time there is no cancer present. While men screened for prostate cancer are 2 to 4 times more likely to be diagnosed, the death rate from prostate cancer is the same for those screened as for those not screened. For men treated aggressively, the risks of consequent impotence and incontinence threaten quality of life.
Healthcare Reform as it presently exists won’t change the fact that the medical profession takes decades to abandon its harmful and wasteful practices. It’s long been medicine’s inside joke that it takes a generation of physicians to be trained, practice and die before meaningful change occurs. The American Cancer Society says it expects to alter its PSA recommendations next year. But why wait? When is the U.S. system of healthcare going to wake up?
EPA unveils plan to analyze and regulate six high-profile chemicals.
A number of recent studies point to the increased incidence of neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease, in the United States. And the October issue of the journal Pediatrics publishes a new government study suggesting that autism, a neurodevelopmental disorder, is more prevalent than previously thought, affecting 1 in every 91 U.S. children.
A search of the literature points to exposure to manganese while self-pumping gasoline, to chronic mercury exposure, to pesticide exposure and to a myriad of unknown factors that may affect genetic expression. A research team from the California-based Parkinson’s Institute recently found that the most common pesticides used in gardening tripled the incidence of Parkinson’s disease. The NIH Website www.medlineplus.gov lists 29 published studies linking Parkinson’s disease with pesticide exposure.
The causes of neurodevelopmental disorders — including autism, ADHD and Asperger’s syndrome — remain elusive. But clearly, to quote Walter Willett, M.D, M.P.H., of Harvard’s Department of Nutrition, the fact that we’ve changed the fat in our diet has a role to play. Changes in diet and activity, the increased use of vaccines, toxins in the environment (including mercury, lead and phthalates) and genetic susceptibility to the multitude of environmental changes could affect our children, whether as individuals or collectively. The combination of factors could impact each child differently.
In an announcement September 29, 2009, the EPA noted that U.S. consumers are “understandably anxious and confused” about chemicals in the environment and in their bodies. Quoted as saying the 1976 toxics law was “inordinately cumbersome and time-consuming”, EPA Administrator Lisa Jackson indicated that in the coming months the Obama administration will promote a new law placing responsibility on the chemical industry to prove that its compounds are safe.
In the interim, Jackson said, the EPA would begin to analyze and regulate six chemicals that have raised high-profile health concerns. These include bisphenol/BPA, found in hard, clear polycarbonate bottles and in dentistry materials; phthalates, found in vinyl and cosmetics; brominated flame retardants; perfluorinated compounds used in nonstick coatings; paraffins found in lubricants; and benzidine dyes and pigments. It is feared that these six chemicals mimic hormones. They have already been linked to reproductive problems, the obstruction of fetal development, cancer and other health disorders.
Using its authority under existing law, EPA may restrict the use of these six chemicals or require that product labels warn consumers of the risks associated with their use.
October 13, 2009
A search of the literature points to exposure to manganese while self-pumping gasoline, to chronic mercury exposure, to pesticide exposure and to a myriad of unknown factors that may affect genetic expression. A research team from the California-based Parkinson’s Institute recently found that the most common pesticides used in gardening tripled the incidence of Parkinson’s disease. The NIH Website www.medlineplus.gov lists 29 published studies linking Parkinson’s disease with pesticide exposure.
The causes of neurodevelopmental disorders — including autism, ADHD and Asperger’s syndrome — remain elusive. But clearly, to quote Walter Willett, M.D, M.P.H., of Harvard’s Department of Nutrition, the fact that we’ve changed the fat in our diet has a role to play. Changes in diet and activity, the increased use of vaccines, toxins in the environment (including mercury, lead and phthalates) and genetic susceptibility to the multitude of environmental changes could affect our children, whether as individuals or collectively. The combination of factors could impact each child differently.
In an announcement September 29, 2009, the EPA noted that U.S. consumers are “understandably anxious and confused” about chemicals in the environment and in their bodies. Quoted as saying the 1976 toxics law was “inordinately cumbersome and time-consuming”, EPA Administrator Lisa Jackson indicated that in the coming months the Obama administration will promote a new law placing responsibility on the chemical industry to prove that its compounds are safe.
In the interim, Jackson said, the EPA would begin to analyze and regulate six chemicals that have raised high-profile health concerns. These include bisphenol/BPA, found in hard, clear polycarbonate bottles and in dentistry materials; phthalates, found in vinyl and cosmetics; brominated flame retardants; perfluorinated compounds used in nonstick coatings; paraffins found in lubricants; and benzidine dyes and pigments. It is feared that these six chemicals mimic hormones. They have already been linked to reproductive problems, the obstruction of fetal development, cancer and other health disorders.
Using its authority under existing law, EPA may restrict the use of these six chemicals or require that product labels warn consumers of the risks associated with their use.
October 13, 2009
Citing steroids in supplements, Congress considers tweaking dietary regulations.
According to the New York Times, federal agents have recently raided several companies suspected of making bodybuilding products that illegally contain steroids and selling them as over-the-counter dietary supplements. On September 29, 2009, Sen. Arlen Specter, D-Pa., chair of the Senate sub-committee on Judiciary, Crime and Drugs, convened a hearing on the topic. The forum was entitled “Body Building Products and Hidden Steroids: Enforcement Barriers”.
The FDA has warned consumers not to use bodybuilding products that contain steroids or steroid-like substances advertised as enhancing testosterone levels. Among the witnesses at the hearing was former college baseball player Jareem Gunter, who suffered acute liver failure after taking a bodybuilding product adulterated with steroids. Steroid-adulterated products are linked to liver failure, kidney damage and other serious health consequences. According to Travis Tygart, chief executive of the US Anti-Doping Agency: “These companies are exploiting the lack of premarket regulation to sell magic powders and pills in a bottle while using the reputation of the health food and vitamin industry to cloak themselves with the appearance of safety and respectability.”
Michael Levy, director of the FDA’s division of new drugs and labeling compliance, stated that the “FDA has to undertake painstaking investigation and analysis to prove they are illegal.” But Richard Kingham, an attorney specializing in food and drug law, stressed that the agency already has enforcement tools sufficient to address these misbranded products.
Sen. Orrin Hatch, R-Utah, the ranking member at the hearing, disagreed with Sen. Specter’s contention that the premarket review of dietary supplements should be reexamined. Instead, Hatch said he continues to push for increased resources at the FDA and DEA in order to enforce more actively existing laws designed to prevent the marketing of illegal steroids masquerading as dietary supplements.
There’s a misconception, continually repeated in the mainstream press, that dietary supplements are unregulated. In fact, since 1994 the FDA has had the authority and responsibility to address misbranded dietary supplements. The dietary supplement industry, in implementing GMP/Good Manufacturing Practice certification and USP certification to police its own, has demonstrated an enviable safety record, according to government statistics. As Michael McGuffin, president of the American Herbal Products Association, stated: “Companies that are willing to ignore current laws would also ignore any new law. Enforcement is a better answer.”
The FDA has warned consumers not to use bodybuilding products that contain steroids or steroid-like substances advertised as enhancing testosterone levels. Among the witnesses at the hearing was former college baseball player Jareem Gunter, who suffered acute liver failure after taking a bodybuilding product adulterated with steroids. Steroid-adulterated products are linked to liver failure, kidney damage and other serious health consequences. According to Travis Tygart, chief executive of the US Anti-Doping Agency: “These companies are exploiting the lack of premarket regulation to sell magic powders and pills in a bottle while using the reputation of the health food and vitamin industry to cloak themselves with the appearance of safety and respectability.”
Michael Levy, director of the FDA’s division of new drugs and labeling compliance, stated that the “FDA has to undertake painstaking investigation and analysis to prove they are illegal.” But Richard Kingham, an attorney specializing in food and drug law, stressed that the agency already has enforcement tools sufficient to address these misbranded products.
Sen. Orrin Hatch, R-Utah, the ranking member at the hearing, disagreed with Sen. Specter’s contention that the premarket review of dietary supplements should be reexamined. Instead, Hatch said he continues to push for increased resources at the FDA and DEA in order to enforce more actively existing laws designed to prevent the marketing of illegal steroids masquerading as dietary supplements.
There’s a misconception, continually repeated in the mainstream press, that dietary supplements are unregulated. In fact, since 1994 the FDA has had the authority and responsibility to address misbranded dietary supplements. The dietary supplement industry, in implementing GMP/Good Manufacturing Practice certification and USP certification to police its own, has demonstrated an enviable safety record, according to government statistics. As Michael McGuffin, president of the American Herbal Products Association, stated: “Companies that are willing to ignore current laws would also ignore any new law. Enforcement is a better answer.”
It's Time to Put "Health" Back into Healthcare! Tell Your Senator to Support True Healthcare Reform
How can we, as a country, reduce exploding healthcare costs? By changing the way we do medicine. Too often we rely on treating symptoms and addressing health problems after they have reached the crisis state. Under the old way of thinking, this usually means hospital stays, vastly expensive surgery, expensive drugs with undesirable side effects, and other procedures common to conventional chronic care.
Preventive medicine should be, by definition, the prevention of disease before it takes hold. Diagnostic tests may be useful for early detection, but they often involve little understood risks such as radiation. Moreover, the screen may be used to redefine normal conditions as pre-diseases requiring expensive and often dangerous lifelong drug treatment. And whether the screen is used to diagnose a pre-disease condition or a disease, the opportunity for true prevention has already passed.
Although both the Senate HELP and Finance Committee healthcare bills incorporate prevention, they do not define what it means in key provisions. Without a clear definition of which preventive measures will be covered by insurance, for example, we could end up with nothing more than a long list of approved screening measures and drugs to be used on all ages, including the very young.
We are concerned that the current healthcare discussion doesn’t go far enough and would actually further constrain your access to a truly integrative and preventive medical model.
Equally alarming are the following provisions in the Senate healthcare bills:
A one-size-fits-all health insurance mandate would impede your right to choose and receive the healthcare that works best for you. It’s not exactly clear which services would be provided by a mandate, but it is apparent that we would have only one option! Those who currently pay out of pocket for healthcare services and opt to work outside of the insurance system or choose to purchase minimal coverage for catastrophic events will have the burden of additional insurance expenses without receiving additional benefits. We may ultimately be unable to afford our healthcare options of choice. Even if we can afford them, the natural healthcare option may be simply regulated away in a one-size-fits-all medical world.
Flexible Spending and Health Savings Accounts will be capped at $2,500. They may also be subject to taxes applied to high-end plans. These types of accounts are frequently used to pay for integrative medicine options, including preventive services. The net impact could be less access to healthy options! Since the house bill is more restrictive of deductibles and thus more destructive of HSA’s, a combined bill could yet eliminate HSA’s entirely.
The Comparative Effectiveness Research (CER) program is structured to reinforce and strengthen the current medical paradigm, which is stacked against integrative medicine. A newly created commission will be charged with identifying and recommending the most effective and appropriate healthcare services and procedures. That commission is required (required!) to include representatives of the pharmaceutical industry, but no one is included from the integrative health community. It’s crucial that less invasive, less expensive and more natural integrative medical treatments be examined and compared in head-to-head studies.
Electronic Medical Records (EMR) are an invasion of privacy and, in the worst case, may be used to target practitioners who are using alternative therapies. The government and potentially many others will have access to all of your EMRs. Do you trust them to keep your records secure? It is also likely that state medical boards, attorneys general and the FDA will access and use these data to target practitioners who offer integrative approaches. Any EMR system should have an option for individuals to opt out!
The Senate Finance Committee voted to pass America’s Healthy Future Act out of committee on Tuesday October 13 and the Senate will now merge the HELP and Finance bills together. Without further amendments, the resulting bill will commit us to one-size-fits-all options, stifling creative innovation, and giving special interests free rein to reinforce the status quo — pushing integrative medicine and true prevention further outside of the medical system.
We need your help! Let’s put “health” back in the healthcare bill! Please write your senators to let them know that you want to see true healthcare reform. If you are a practitioner, please identify your area of practice and highlight the need to ensure equal footing for natural and integrative medicine. Take Action Here
Preventive medicine should be, by definition, the prevention of disease before it takes hold. Diagnostic tests may be useful for early detection, but they often involve little understood risks such as radiation. Moreover, the screen may be used to redefine normal conditions as pre-diseases requiring expensive and often dangerous lifelong drug treatment. And whether the screen is used to diagnose a pre-disease condition or a disease, the opportunity for true prevention has already passed.
Although both the Senate HELP and Finance Committee healthcare bills incorporate prevention, they do not define what it means in key provisions. Without a clear definition of which preventive measures will be covered by insurance, for example, we could end up with nothing more than a long list of approved screening measures and drugs to be used on all ages, including the very young.
We are concerned that the current healthcare discussion doesn’t go far enough and would actually further constrain your access to a truly integrative and preventive medical model.
Equally alarming are the following provisions in the Senate healthcare bills:
A one-size-fits-all health insurance mandate would impede your right to choose and receive the healthcare that works best for you. It’s not exactly clear which services would be provided by a mandate, but it is apparent that we would have only one option! Those who currently pay out of pocket for healthcare services and opt to work outside of the insurance system or choose to purchase minimal coverage for catastrophic events will have the burden of additional insurance expenses without receiving additional benefits. We may ultimately be unable to afford our healthcare options of choice. Even if we can afford them, the natural healthcare option may be simply regulated away in a one-size-fits-all medical world.
Flexible Spending and Health Savings Accounts will be capped at $2,500. They may also be subject to taxes applied to high-end plans. These types of accounts are frequently used to pay for integrative medicine options, including preventive services. The net impact could be less access to healthy options! Since the house bill is more restrictive of deductibles and thus more destructive of HSA’s, a combined bill could yet eliminate HSA’s entirely.
The Comparative Effectiveness Research (CER) program is structured to reinforce and strengthen the current medical paradigm, which is stacked against integrative medicine. A newly created commission will be charged with identifying and recommending the most effective and appropriate healthcare services and procedures. That commission is required (required!) to include representatives of the pharmaceutical industry, but no one is included from the integrative health community. It’s crucial that less invasive, less expensive and more natural integrative medical treatments be examined and compared in head-to-head studies.
Electronic Medical Records (EMR) are an invasion of privacy and, in the worst case, may be used to target practitioners who are using alternative therapies. The government and potentially many others will have access to all of your EMRs. Do you trust them to keep your records secure? It is also likely that state medical boards, attorneys general and the FDA will access and use these data to target practitioners who offer integrative approaches. Any EMR system should have an option for individuals to opt out!
The Senate Finance Committee voted to pass America’s Healthy Future Act out of committee on Tuesday October 13 and the Senate will now merge the HELP and Finance bills together. Without further amendments, the resulting bill will commit us to one-size-fits-all options, stifling creative innovation, and giving special interests free rein to reinforce the status quo — pushing integrative medicine and true prevention further outside of the medical system.
We need your help! Let’s put “health” back in the healthcare bill! Please write your senators to let them know that you want to see true healthcare reform. If you are a practitioner, please identify your area of practice and highlight the need to ensure equal footing for natural and integrative medicine. Take Action Here
Monday, July 13, 2009
New Bill (HR2749) Gives FDA Unheard-of Power over Small Farmers, Food and Supplement Producers
A new, long-awaited food safety bill is now before the US House of Representatives. It is the Food Safety Enhancement Act of 2009, or FSEA. Introduced by Reps. Henry Waxman (D–CA) and John Dingell (D–MI), the FSEA is meant to address food safety concerns. But as you will see, much of it is not about food safety at all. Food safety issues have arisen from large agricultural operations. But this bill places its harshest burdens on small food producers and supplement producers.
Take Action and let your Representative know you DO NOT support this bill
The Food Safety Enhancement Act:
- gives the US Food and Drug Administration (FDA) unprecedented scope, authority, and power over small farmers, food producers, and supplement producers, including the power to use vague language to intimidate and threaten;
- imposes unjustifiably harsh criminal and civil penalties for even administrative violations; and
- places undue economic hardship on small and mid-sized farms and food facilities (both organic and conventional), which could easily drive many of them out of business, and lead to monopoly control of food by large corporations.
Also known as the Waxman–Dingell bill, the Food Safety Enhancement Act has a number of provisions that would directly affect many of AAHF’s members. Although much of the bill’s language is vague—and, some worry, deliberately deceptive—it is clear that the FSEA provides for the following:
Click Here to Continue Reading...
Monday, June 15, 2009
An Update on our Social Media Sites!
Social Media Sites are taking the world by storm. They are transforming the way we access and receive news and information and connect and communicate with each other on a daily basis. AAHF has joined many of these new and fast-growing networks in an effort to spread awareness about our organization and to help keep members in the loop on the latest news from the alternative medicine field.
It all started with three simple words, “You’ve got Mail.” We all remember that adorable romantic comedy, where a couple fell in love, *gasp* over the internet! What was thought of as a new and revolutionary way to meet people has now become the norm. Relationships are now being established and built through connections made on social networking sites. Organizations are no longer sending letters and gaining membership through face-to-face interaction, but through “Tweeting with Tweeples.” And although this new way of communication may seem complicated and confusing, these sites are surprisingly simple and are gaining membership at an extremely rapid pace.
The basic concept behind these sites is networking. Sure, Facebook may have started out as a way for college students to express themselves and socialize with their friends online. However, organizations soon realized that those friend networks could be used to spread the word about their campaigns, creating new networks of people working to spread the word about their issues.
AAHF has created accounts for Facebook, Blogspot, Twitter and MySpace and we actively update each site and recruit new friends and followers every day. Our Facebook account, which can be found by searching for friends through E-Mail at office@healthfreedom.org --- has 563 friends and counting. On our profile, we post information about our organization, links to our campaigns, articles and photos and live-streaming updates from our Twitter. We can also send private messages to members and comment on others’ walls.
Our MySpace is another online community that helps us stay connected. MySpace provides users with an extensive profile, allowing us to share everything from what our organization’s goals are to what books and movies we would like to endorse. The site also automatically streams and links to our blog posts, Facebook activity and Twitter “Tweets,” connecting all of our Social Networking Sites easily and accessibly. You can add us by simply searching MySpace for “American Association for Health Freedom.”
Although we have had our blog for quite some time, we are now beginning to post articles twice weekly on the latest alternative health issues. We hope that the topics we choose will spark comments and start conversations and we encourage everyone to subscribe to our blog and voice your opinions there. Our blog site is http://thehealthfreedom.blogspot.com. You can chose to “Follow” our blog by clicking on the Follow button in the top left corner. This will allow you to receive updates whenever we have a new post or someone replies to one of your comments.
Finally, Twitter is currently the newest and most talked about social networking site that we have become involved with. We post server “tweets,” which are short comments that give our followers current information and news. These Tweets include updates on what’s going on in our organization and the alternative medicine community, links to relevant articles and websites, and Q and A between our twitter and another. If you don’t already “Tweet”, we strongly encourage you to join! Twitter is a great way to get information on what you are interested in, straight to your phone and computer. Twitter.com provides you with a short, simple video detailing everything you need to know to get started. To find us on Twitter, go to http://twitter.com/healthfreedom and join our 89 plus followers.
Thursday, June 11, 2009
Is Health Care Reform Moving Too Fast?
All this talk about health care reform ... has there been adequate time and transparency to develop a comprehensive workable plan? A matter of this importance which affects every single American needs to be discussed in the public domain. Open the closed-door dealings. Deals are being struck and discussions are being had that the general public is not privy to.
Senator Enzi (R-Wyo) expressed concern over the 'focus that some Democrats have placed on meeting arbitrary deadlines over getting the legislation done right.' The deadline to meet some random politically inspired timeline could cause a glossing over of the details. Are we going to be presented a bill in the 11th hour that will be forced through Congress without time for public comment or perhaps even a thorough review by Congress?
Wednesday, March 04, 2009
Press Release: NEW SCIENCE POINTS TO IMPORTANCE OF HIGH-DOSE SUPPLEMENTS
For Immediate Release:
March 3, 2009
US Contact:
Tami L. Wahl, 800.230.2762
International Contact:
Dr. Robert Verkerk, 44.1306.646.600
NEW SCIENCE POINTS TO IMPORTANCE OF HIGH-DOSE SUPPLEMENTS
Calcium, B Vitamins, and Vitamin D Play Important Roles
Three new pieces of research reveal the importance of higher supplement doses. The February 23 issue of Archives of Internal Medicine, a highly respected, peer-reviewed medical journal published by the American Medical Association, includes three studies that demonstrate the benefits of high-dose nutritional supplements, which suggests that the methods being used to determine “maximum safe dosages” in the US and Europe are greatly flawed.
The American Association for Health Freedom (AAHF) and its European counterpart, the Alliance for Natural Health (ANH), have long argued that the methodology used to determine dosage greatly overestimates the risks—and completely ignores the benefits—of higher dosages. Dr. Robert Verkerk, Executive and Scientific Director of ANH, commented, “These latest studies, all published in single edition of Archives of Internal Medicine, provide important information about the roles of B vitamins in age-related macular degeneration, calcium in cancer prevention, and vitamin D in reducing the risk of upper respiratory tract infections.”
Dr. Verkerk continued, “In all cases the levels that delivered the best results were the highest doses tested, and these levels are well over those that the European Commission (EC) wants to see banned.” The EC is pushing for very low MPLs, or Maximum Permitted Levels, for supplements sold in Europe, creating concerns that the high-dose supplements commonly consumed in Ireland, the UK, the Netherlands, and Sweden may be stripped from shelves.
AAHF Legislative Director Tami Wahl agreed: “Vitamins and supplements, combined with other healthy habits, play an integral role in the prevention of many medical conditions and diseases. Our concern is that the dosage amounts currently recommended are simply not adequate to yield protective effects.”
Dr. Verkerk added, “There is an increasing body of science, which these new papers in Archives of Internal Medicine support, that shows high doses of supplements are both safe and effective. To get some perspective on it, the levels found to be most beneficial in preventing macular degeneration were over twelve times the US’s Recommended Daily Allowance (RDA) of folate, twenty-five times the RDA of vitamin B6, and 1000 times the RDA of vitamin B12.”
In a recent presentation at a public meeting of the Food Safety Consultative Council of the Food Safety Authority of Ireland, Dr. Verkerk demonstrated that the amounts of vitamins and minerals commonly consumed in a single healthy meal are often well in excess of those that are considered to be “maximum safe levels,” and may even be exceeded in a single unhealthy meal!
AAHF Executive Director Gretchen DuBeau adds, “Recent studies—which were funded by pharmaceutical manufacturers - that questioned the benefits from supplement use have not been based on good science and create unfounded confusion for consumers who are simply trying to make the best and most informed healthcare decision. Ironically, most of the recent studies questioning the efficacy of vitamins have used minimal doses, not the potentially helpful doses tested in the three recent studies that found vitamins to be useful.”
AAHF believes that any type of noninvasive and inexpensive treatment that assists in the prevention of life-threatening or life-changing diseases like age-related macular degeneration should be strongly encouraged and endorsed by the medical community as a whole. AAHF continues to push US regulators to accept a more rational scientific and legal framework in creating food supplement maximum doses.
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net.
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.
About the Alliance for Natural Health (ANH):www.anhcampaign.org
ANH is an international, non-governmental organization, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to promote natural and sustainable health, using the principles of good science and good law.
March 3, 2009
US Contact:
Tami L. Wahl, 800.230.2762
International Contact:
Dr. Robert Verkerk, 44.1306.646.600
NEW SCIENCE POINTS TO IMPORTANCE OF HIGH-DOSE SUPPLEMENTS
Calcium, B Vitamins, and Vitamin D Play Important Roles
Three new pieces of research reveal the importance of higher supplement doses. The February 23 issue of Archives of Internal Medicine, a highly respected, peer-reviewed medical journal published by the American Medical Association, includes three studies that demonstrate the benefits of high-dose nutritional supplements, which suggests that the methods being used to determine “maximum safe dosages” in the US and Europe are greatly flawed.
The American Association for Health Freedom (AAHF) and its European counterpart, the Alliance for Natural Health (ANH), have long argued that the methodology used to determine dosage greatly overestimates the risks—and completely ignores the benefits—of higher dosages. Dr. Robert Verkerk, Executive and Scientific Director of ANH, commented, “These latest studies, all published in single edition of Archives of Internal Medicine, provide important information about the roles of B vitamins in age-related macular degeneration, calcium in cancer prevention, and vitamin D in reducing the risk of upper respiratory tract infections.”
Dr. Verkerk continued, “In all cases the levels that delivered the best results were the highest doses tested, and these levels are well over those that the European Commission (EC) wants to see banned.” The EC is pushing for very low MPLs, or Maximum Permitted Levels, for supplements sold in Europe, creating concerns that the high-dose supplements commonly consumed in Ireland, the UK, the Netherlands, and Sweden may be stripped from shelves.
AAHF Legislative Director Tami Wahl agreed: “Vitamins and supplements, combined with other healthy habits, play an integral role in the prevention of many medical conditions and diseases. Our concern is that the dosage amounts currently recommended are simply not adequate to yield protective effects.”
Dr. Verkerk added, “There is an increasing body of science, which these new papers in Archives of Internal Medicine support, that shows high doses of supplements are both safe and effective. To get some perspective on it, the levels found to be most beneficial in preventing macular degeneration were over twelve times the US’s Recommended Daily Allowance (RDA) of folate, twenty-five times the RDA of vitamin B6, and 1000 times the RDA of vitamin B12.”
In a recent presentation at a public meeting of the Food Safety Consultative Council of the Food Safety Authority of Ireland, Dr. Verkerk demonstrated that the amounts of vitamins and minerals commonly consumed in a single healthy meal are often well in excess of those that are considered to be “maximum safe levels,” and may even be exceeded in a single unhealthy meal!
AAHF Executive Director Gretchen DuBeau adds, “Recent studies—which were funded by pharmaceutical manufacturers - that questioned the benefits from supplement use have not been based on good science and create unfounded confusion for consumers who are simply trying to make the best and most informed healthcare decision. Ironically, most of the recent studies questioning the efficacy of vitamins have used minimal doses, not the potentially helpful doses tested in the three recent studies that found vitamins to be useful.”
AAHF believes that any type of noninvasive and inexpensive treatment that assists in the prevention of life-threatening or life-changing diseases like age-related macular degeneration should be strongly encouraged and endorsed by the medical community as a whole. AAHF continues to push US regulators to accept a more rational scientific and legal framework in creating food supplement maximum doses.
— 30 —
NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net.
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.
About the Alliance for Natural Health (ANH):www.anhcampaign.org
ANH is an international, non-governmental organization, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to promote natural and sustainable health, using the principles of good science and good law.
Wednesday, February 18, 2009
Letter to the Editor: Vitamins are Harmful?
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
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
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.
Monday, January 12, 2009
For immediate release: January 12, 2009
U.S. Contact:
Gretchen DuBeau, ph 800-230-2762
European/International Contact:
Dr Robert Verkerk, ph +44-1306-646-600
VITAMIN EXPERTS CONDEMN HARVARD STUDY
Today the American Association for Health Freedom (AAHF) and the Alliance for Natural Health (ANH) have together sharply criticized defective and misleading research published on January 7 in The Journal of the National Cancer Institute, which claims that vitamins don’t prevent cancer.
The ANH has released its critique on the study by Dr Jennifer Lin and colleagues at the Harvard Medical School, which concludes that the lack of effects demonstrated could have been predicted before the start of the 8-year study involving over 7,600 women with heart disease or high risk of it who averaged 60 years of age.
“This study was destined from the outset to obtain a negative result” said Dr Damien Downing, medical director of ANH, a practicing medical doctor who has practiced nutritional and environmental medicine for over 25 years. Dr Downing also criticized the journal editor for publishing the study “in the knowledge that the data do not support the conclusions."
Dr Robert Verkerk, scientific director of ANH, said: “Diet is the single biggest factor contributing to cancer, and there is a rapidly growing body of both research and clinical evidence to show that concentrated forms of nutrients including vitamins, minerals and botanicals are invaluable in cancer prevention.”
ANH’s critique shows that the study has no bearing on the effects of the three vitamins used, vitamins C and E and beta-carotene, on cancer prevention in healthy people. “Many of the risk factors associated with heart disease and cancer are shared, and nearly 80% of the women in the study were overweight or obese, therefore likely to have been much more susceptible to cancer than a non-diseased, healthy population. Some may even have been presymptomatic”, adds Dr Verkerk.
The ANH expert group also emphasized that the dosages and forms selected for the study did not equate with those that would be most likely to yield a positive result. Synthetic vitamin C ( synthetic form) was only 500mg, vitamin E (alpha- tocopherol only) was 600IU every other day, and synthetic beta carotene was 50 mg every other day, all very low doses, and compliance among study participants in actually taking the vitamins was poor, especially poor in taking all three vitamins. As few as half the participants appear to have done so. In addition, “Most people who are keen to prevent cancer don’t just take these three vitamins”, Dr Verkerk pointed out, “they take a whole range of vitamin, minerals and phytonutrients most of which have been independently verified to have powerful anti-cancer effects”.
Dr Steve Hickey, another member of ANH’s expert group, referred to the approach used by the Harvard team as “cookbook science”. He said: “Certain researchers have hit on a cookbook recipe for performing studies, purporting to show that antioxidant vitamins ( generally at low doses) are ineffective. In the most recent case, Jennifer Lin and colleagues use this approach to make the unfounded claim that antioxidant vitamins do not prevent cancer”.
Gretchen DuBeau, Executive Director of the ANH’s US affiliate, added: “It’s unfortunate that the media has compounded this misinformation by incorrectly reporting the erroneous results as applicable to the general population.”
ENDS.
NOTES TO THE EDITOR
Journal of the National Cancer Institute Study
Full scientific reference: Jennifer Lin, Nancy R. Cook, Christine Albert, Elaine Zaharris, J. Michael Gaziano, Martin Van Denburgh, Julie E. Buring, and JoAnn E. Manson. Vitamins C and E and Beta Carotene Supplementation and Cancer Risk: A Randomized Controlled Trial. J Natl Cancer Inst 2009; 101: 14-23.
Abstract available at: http://jnci.oxfordjournals.org/cgi/content/abstract/djn438
Alliance for Natural Health rebuttal
ANH website feature on rebuttal: http://www.anhcampaign.org/news/cancer-prevention-study-or-study-designed-to-prevent-vitamin-sales
“Cookbook science” critique by Drs Steve Hickey and Robert Verkerk: www.anhcampaign.org/files/090108_Cookbook-science_final_0.pdf
ANH’s full rebuttal: www.anhcampaign.org/files/090108_ANH_rebuttal_Lin_JNCI_final.pdf
About the Alliance for Natural Health (ANH)
www.anhcampaign.org
The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to protect and promote natural healthcare, using the principles of good science and good law.
The ANH’s overriding goal is to help develop appropriate legal and scientific frameworks for the development of sustainable approaches to healthcare. As in the fields of energy and agriculture, sustainable healthcare invariably requires use of natural products which are inherently compatible with human biochemistry and physiology. Within this setting, consumers and health professionals should be able to make informed choices about a wide range of health options, and in particular those that relate to diet, lifestyle, traditional medicinal and non-drug-based or natural therapies, so that they may experience their benefits to the full while avoiding unnecessary risks.
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 and crafting legislation; acting as a government watchdog and filing comments on proposed rulings; educating the public, press, and decision-makers on integrative medicine; initiating legal actions and joining and forming significant coalitions.
U.S. Contact:
Gretchen DuBeau, ph 800-230-2762
European/International Contact:
Dr Robert Verkerk, ph +44-1306-646-600
VITAMIN EXPERTS CONDEMN HARVARD STUDY
Doctors and scientists say study was flawed
Today the American Association for Health Freedom (AAHF) and the Alliance for Natural Health (ANH) have together sharply criticized defective and misleading research published on January 7 in The Journal of the National Cancer Institute, which claims that vitamins don’t prevent cancer.
The ANH has released its critique on the study by Dr Jennifer Lin and colleagues at the Harvard Medical School, which concludes that the lack of effects demonstrated could have been predicted before the start of the 8-year study involving over 7,600 women with heart disease or high risk of it who averaged 60 years of age.
“This study was destined from the outset to obtain a negative result” said Dr Damien Downing, medical director of ANH, a practicing medical doctor who has practiced nutritional and environmental medicine for over 25 years. Dr Downing also criticized the journal editor for publishing the study “in the knowledge that the data do not support the conclusions."
Dr Robert Verkerk, scientific director of ANH, said: “Diet is the single biggest factor contributing to cancer, and there is a rapidly growing body of both research and clinical evidence to show that concentrated forms of nutrients including vitamins, minerals and botanicals are invaluable in cancer prevention.”
ANH’s critique shows that the study has no bearing on the effects of the three vitamins used, vitamins C and E and beta-carotene, on cancer prevention in healthy people. “Many of the risk factors associated with heart disease and cancer are shared, and nearly 80% of the women in the study were overweight or obese, therefore likely to have been much more susceptible to cancer than a non-diseased, healthy population. Some may even have been presymptomatic”, adds Dr Verkerk.
The ANH expert group also emphasized that the dosages and forms selected for the study did not equate with those that would be most likely to yield a positive result. Synthetic vitamin C ( synthetic form) was only 500mg, vitamin E (alpha- tocopherol only) was 600IU every other day, and synthetic beta carotene was 50 mg every other day, all very low doses, and compliance among study participants in actually taking the vitamins was poor, especially poor in taking all three vitamins. As few as half the participants appear to have done so. In addition, “Most people who are keen to prevent cancer don’t just take these three vitamins”, Dr Verkerk pointed out, “they take a whole range of vitamin, minerals and phytonutrients most of which have been independently verified to have powerful anti-cancer effects”.
Dr Steve Hickey, another member of ANH’s expert group, referred to the approach used by the Harvard team as “cookbook science”. He said: “Certain researchers have hit on a cookbook recipe for performing studies, purporting to show that antioxidant vitamins ( generally at low doses) are ineffective. In the most recent case, Jennifer Lin and colleagues use this approach to make the unfounded claim that antioxidant vitamins do not prevent cancer”.
Gretchen DuBeau, Executive Director of the ANH’s US affiliate, added: “It’s unfortunate that the media has compounded this misinformation by incorrectly reporting the erroneous results as applicable to the general population.”
ENDS.
NOTES TO THE EDITOR
Journal of the National Cancer Institute Study
Full scientific reference: Jennifer Lin, Nancy R. Cook, Christine Albert, Elaine Zaharris, J. Michael Gaziano, Martin Van Denburgh, Julie E. Buring, and JoAnn E. Manson. Vitamins C and E and Beta Carotene Supplementation and Cancer Risk: A Randomized Controlled Trial. J Natl Cancer Inst 2009; 101: 14-23.
Abstract available at: http://jnci.oxfordjournals.org/cgi/content/abstract/djn438
Alliance for Natural Health rebuttal
ANH website feature on rebuttal: http://www.anhcampaign.org/news/cancer-prevention-study-or-study-designed-to-prevent-vitamin-sales
“Cookbook science” critique by Drs Steve Hickey and Robert Verkerk: www.anhcampaign.org/files/090108_Cookbook-science_final_0.pdf
ANH’s full rebuttal: www.anhcampaign.org/files/090108_ANH_rebuttal_Lin_JNCI_final.pdf
About the Alliance for Natural Health (ANH)
www.anhcampaign.org
The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to protect and promote natural healthcare, using the principles of good science and good law.
The ANH’s overriding goal is to help develop appropriate legal and scientific frameworks for the development of sustainable approaches to healthcare. As in the fields of energy and agriculture, sustainable healthcare invariably requires use of natural products which are inherently compatible with human biochemistry and physiology. Within this setting, consumers and health professionals should be able to make informed choices about a wide range of health options, and in particular those that relate to diet, lifestyle, traditional medicinal and non-drug-based or natural therapies, so that they may experience their benefits to the full while avoiding unnecessary risks.
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 and crafting legislation; acting as a government watchdog and filing comments on proposed rulings; educating the public, press, and decision-makers on integrative medicine; initiating legal actions and joining and forming significant coalitions.
Tuesday, December 09, 2008
Important Update about Reforming the FDA
The FDA is a broken agency that censors medical science, obstructs innovation, and protects the medical monopolies that pay for much of its budget. The FDA needs reform, and we need your help to do it. Elected officials and government agencies know that numbers matter. When the public is aroused and demands action, Congressional action usually follows.
Even while the FDA is approving faulty and dangerous drugs and medical devices by the thousands, it continues what can only be described as a harassment campaign against those who want to rely on wholesome foods, dietary supplements, and lifestyle changes to achieve natural good health.
Here are just a few recent examples:
□ FDA employees recently protested in a letter to Congress that they have been forced to approve medical devices against their better judgment. The letter stated that FDA managers “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” The devices that FDA regulates impact more than 500 million adult and pediatric procedures performed every year in the U.S.
□ The FDA’s current efforts to reinterpret and thus amend the Federal Food, Drug, and Cosmetic Act threaten continued access to dietary supplements. If the FDA got its way, a food constituent studied for medical use (and published) could thereafter not be used as a new supplement. To illustrate how this might work, one company's fish oil is now an approved drug, and by this definition any new supplement with fish oil added might be prohibited. AAHF provided formal comments in response to the FDA’s deliberation process and explained why current law prohibits the FDA from adopting these anti-supplement regulations.
The FDA approves toxic chemicals for use in baby formula, baby bottles, and prescription drugs.
□ The FDA stated that no amount of melamine was safe in infant formula. Then melamine was found in formula at levels below 1 ppm. Suddenly the agency reversed itself and stated that melamine was safe provided that (coincidentally) there was no more than 1ppm. Was there a new study or other science to justify this claim? No. It appears to have been made up out of thin air in order to protect commercial interests. Melamine is a toxic chemical that has been linked to kidney damage and children are especially vulnerable.
□ The FDA recently declared Bisphenol – a (BPA) exposure to be safe for infants, even though Canada has banned the chemical from baby bottles. Thirty-six scientific advisers on an independent government panel concluded that the draft decision of the FDA on BPA used “unacceptable criteria for selecting data and depend(ed) heavily upon a key paper that is fatally flawed.” These experts concluded that the FDA chose industry-funded research studies and appeared to ignore hundreds of studies that have been funded by NIH (National Institute for Health) and its counterpart in other countries. BPA is linked to cardiovascular disease, type 2 diabetes, and liver enzyme abnormalities. In addition to being used in baby bottles, it is also used in water bottles, canned goods, dental fillings, children’s teeth sealants, and orthodontic sealants.
□ The FDA has approved the use of phthalates in prescription drugs and over-the-counter medications despite the fact that Congress banned phthalates in toys and other children’s products. Widely used as plasticizers, phthalates have been linked to abnormal reproductive organs, sperm damage, and reduced testosterone in animal tests as well as some human studies.
The epidemics currently plaguing this country-- cancer, obesity, diabetes, asthma and allergies, and many other debilitating disorders-- are linked to manmade products and processes that the FDA has approved and promoted. These failures have resulted in the sickest generation in the history of this country. The agency seems to have lost sight of its mandate to protect the public and has instead come to see itself as the guardian of corporate interests. It is time to end the many conflicts of interest linking the FDA to the pharmaceutical and chemical industries, conflicts of interest that betray the public and harm so many American consumers. It is time to reform the FDA!
Spread the word. Together, we can make a difference. We can turn the FDA around and help restore our national health. Please sign AAHF’s petition to reform the FDA at www.reformFDA.org.
Even while the FDA is approving faulty and dangerous drugs and medical devices by the thousands, it continues what can only be described as a harassment campaign against those who want to rely on wholesome foods, dietary supplements, and lifestyle changes to achieve natural good health.
Here are just a few recent examples:
□ FDA employees recently protested in a letter to Congress that they have been forced to approve medical devices against their better judgment. The letter stated that FDA managers “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” The devices that FDA regulates impact more than 500 million adult and pediatric procedures performed every year in the U.S.
□ The FDA’s current efforts to reinterpret and thus amend the Federal Food, Drug, and Cosmetic Act threaten continued access to dietary supplements. If the FDA got its way, a food constituent studied for medical use (and published) could thereafter not be used as a new supplement. To illustrate how this might work, one company's fish oil is now an approved drug, and by this definition any new supplement with fish oil added might be prohibited. AAHF provided formal comments in response to the FDA’s deliberation process and explained why current law prohibits the FDA from adopting these anti-supplement regulations.
The FDA approves toxic chemicals for use in baby formula, baby bottles, and prescription drugs.
□ The FDA stated that no amount of melamine was safe in infant formula. Then melamine was found in formula at levels below 1 ppm. Suddenly the agency reversed itself and stated that melamine was safe provided that (coincidentally) there was no more than 1ppm. Was there a new study or other science to justify this claim? No. It appears to have been made up out of thin air in order to protect commercial interests. Melamine is a toxic chemical that has been linked to kidney damage and children are especially vulnerable.
□ The FDA recently declared Bisphenol – a (BPA) exposure to be safe for infants, even though Canada has banned the chemical from baby bottles. Thirty-six scientific advisers on an independent government panel concluded that the draft decision of the FDA on BPA used “unacceptable criteria for selecting data and depend(ed) heavily upon a key paper that is fatally flawed.” These experts concluded that the FDA chose industry-funded research studies and appeared to ignore hundreds of studies that have been funded by NIH (National Institute for Health) and its counterpart in other countries. BPA is linked to cardiovascular disease, type 2 diabetes, and liver enzyme abnormalities. In addition to being used in baby bottles, it is also used in water bottles, canned goods, dental fillings, children’s teeth sealants, and orthodontic sealants.
□ The FDA has approved the use of phthalates in prescription drugs and over-the-counter medications despite the fact that Congress banned phthalates in toys and other children’s products. Widely used as plasticizers, phthalates have been linked to abnormal reproductive organs, sperm damage, and reduced testosterone in animal tests as well as some human studies.
The epidemics currently plaguing this country-- cancer, obesity, diabetes, asthma and allergies, and many other debilitating disorders-- are linked to manmade products and processes that the FDA has approved and promoted. These failures have resulted in the sickest generation in the history of this country. The agency seems to have lost sight of its mandate to protect the public and has instead come to see itself as the guardian of corporate interests. It is time to end the many conflicts of interest linking the FDA to the pharmaceutical and chemical industries, conflicts of interest that betray the public and harm so many American consumers. It is time to reform the FDA!
Spread the word. Together, we can make a difference. We can turn the FDA around and help restore our national health. Please sign AAHF’s petition to reform the FDA at www.reformFDA.org.
Tuesday, November 25, 2008
FDA's Latest Threat to Dietary Supplements Defies DSHEA
For Immediate Release:
U.S. Contact: Gretchen DuBeau,
ph 800-230-2762
International Contact: Dr Robert Verkerk,
ph +44-1306-646-600
November 25, 2008
FDA’S LATEST THREAT TO DIETARY SUPPLEMENTS DEFIES THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT ACCORDING TO TWO LEADING HEALTH FREEDOM GROUPS
Today, the American Association for Health Freedom (AAHF) and its international affiliate, the Alliance for Natural Health (ANH), jointly submitted comments to the US Food and Drug Administration (FDA) in response to its request for comments from industry and consumers to help them interpret recent changes to Section 912 of the Amendments Act of 2007 (FDAAA). The submission was accompanied by comments from 700 concerned citizens and practitioners exasperated over the latest threat to supplements from the FDA. The FDA’s unprecedented, controversial, and ambiguous changes to Section 912, specifically the addition of Section 301 (ll), may mean that all food products, including dietary supplements, could be barred from being marketed if they have been the subject of published clinical studies. AAHF and ANH point out that this provision is so far-reaching that a very large number of commonly consumed foods could be impacted by the new regulation and hence barred from interstate trade.
“If the FDA determines that Section 301 applies to dietary supplements, this would strangle innovation. It would create a ‘Catch 22’ situation in which supplement producers who undertake scientific research on new supplements will find that their very research will lead to a ban on the proposed supplement. This is totally senseless. This is too senseless even for the FDA,” said Gretchen DuBeau, AAHF Executive Director.
At the crux of the issue is whether the new Section 301 applies to dietary supplements, which are already covered by Section 201 (ff) of the Federal Food, Drug, and Cosmetic Act (FDCA). This means that Section 301 is in direct conflict with Section 201 of the FDCA that already governs dietary supplements through the Dietary Supplements Health and Education Act (DSHEA). DuBeau added:
“This conflict—which is supported by influential case law— gives Section 301 of the FDAAA no legal basis. Congressional language has already made clear and unambiguous that the FDAAA, currently under consideration, shall not affect the regulation of supplements under DSHEA.”
Section 201 currently also prevents the marketing of dietary supplements which have been subject to published clinical studies—but only when they have also been the subject of a Investigational New Drug (IND) application.
Dr Robert Verkerk, executive and scientific director of the ANH emphasized:
“Unlike Section 201 of the FDCA, the proposed new Section 301 of the FDA Amendments Act doesn’t just limit the ban to supplements that have been subject to drug applications, it applies a ban to some of the best researched and most useful supplements and ingredients on the market today. This is clearly nonsensical and if enforced, would represent one of the most severe restrictions seen in any country at any time.”
“There will be no shortage of big corporations that will exploit this situation to their benefit unless the scope of Section 301 is both clarified and narrowed”, commented Gretchen DuBeau, “one such company is already trying to use it to ban the natural zero-caloric sweetener stevia, given that stevia has been subject to scientific research and has been a thorn in the side of the sugar and artificial sweetener giants for years.”
Since the FDA’s call for comments issued on July 28, 2008, the AAHF sent an alert to its members, including professional, integrative medicine organizations, apprising them of the threat posed by the FDAAA’s Section 912. More than 700 concerned doctors and citizens emailed comments to AAHF, which accompanied the AAHF’s joint submission with ANH. Among the prestigious groups opposing the FDA’s erroneous interpretation are the International College of Integrative Medicine (ICIM), the American College for Advancement in Medicine (ACAM), The American Holistic Medical Association (AHMA), the Certification Board for Nutrition Specialists (CBNS), and the American College of Nutrition (ACN).
ENDS.
Friday, November 21, 2008
FAULTY STUDY TARGETS VITAMINS C AND E
U.S. Contact:
Gretchen DuBeau,
ph 800-230-2762
International Contact:
Dr Robert Verkerk,
ph +44-1306-646-600
November 18, 2008
FAULTY STUDY TARGETS VITAMINS C AND E
Finding of No Cardiovascular Protection Was Predictable
Today, the American Association for Health Freedom (AAHF) and its international affiliate, the Alliance for Natural Health (ANH), have together sharply criticized defective and misleading research published earlier this month in the Journal of the American Medical Association (JAMA). The research triggered headlines around the world suggesting that neither vitamin E nor vitamin C supplements protect against cardiovascular disease in older men.
The study by Howard Sesso and colleagues from Harvard, entitled the “Physicians’ Health Study II”, included over 14,600 male physicians over a ten year period, used the least potent form of vitamin E and incorrect dosages of both vitamins C and E , according to an analysis conducted by ANH experts, Dr Steve Hickey, Dr. Damien Downing, and Dr. Robert Verkerk.
The ANH analysis, “Designed to Fail: A Trial Without Meaning”, criticized the Sesso et al. study for using synthetic dl-alpha-tocopherol, which is less effective than the natural and more complete forms of vitamin E and is thus more likely to not reveal any benefit. Additionally, the vitamin E dose in the study (400 IU every other day) is far below the dose taken by many who supplement making the findings irrelevant to older supplement consumers who are aware of extensive research and clinical evidence on higher dose vitamin therapy.
The JAMA paper included a 500 mg daily dosage of vitamin C, which is only half of a typical one-gram tablet of the type popular with supplement users. Evidence suggests that dynamic flow levels of vitamin C, which may prevent heart disease, begin at daily intakes above about 3g per day, best delivered in divided doses.
Additional complaints about the JAMA study include the use of an unidentified placebo, which may have included beneficial nutrients such as magnesium, failure to control diet for synergistic nutrient interactions that may have skewed test results, and the relevance, or otherwise, of applying these findings among physicians (the study group) to all men across the population.
“Considering that the methodologies were significantly biased against finding a positive result from vitamins C and E as determined from both available research and clinical evidence, one has to ask who stands to benefit from these findings? How, for example, would the pharmaceutical industry be impacted from diminished sales of their vitamins if people, under the belief that vitamins provided no benefit in the treatment and prevention of cardiovascular disease, instead chose pricey prescription drugs,” asked Gretchen DuBeau, AAHF Executive Director.
Dr Damien Downing, ANH Medical Director, President of the British Society of Ecological Medicine and Editor-in-Chief of the peer reviewed journal, the Journal of Nutritional and Environmental Medicine, on reading the Sesso et al. paper independently responded, saying it was “an intervention designed to fail”!
ANH Scientific & Executive Director, Dr Robert Verkerk added, “With three of the world’s largest drug companies, namely BASF, Wyeth and DSM—formerly Roche—supplying the low dose synthetic vitamins for the study, it’s perhaps not surprising that the outcome is made to look bad for vitamins. A trial like this costs a huge amount of money and is a waste of much needed research funds. Why don’t they ask the people who work with nutrients on a daily basis—integrative medicine doctors—what nutrient forms, combinations and dosages are most likely to work?”
The ANH analysis, “Designed to Fail: A Trial Without Meaning”, is available at: http://www.anhcampaign.org/files/081117_Sesso_PHSII_ANHrebuttal.pdf.
ENDS.
NOTES TO THE EDITOR
About the American Association for Health Freedom (AAHF)
http://www.healthfreedom.net/
The American Association for Health Freedom (AAHF) is a 501©4 nonprofit organization serving as the politically active voice at federal and state levels to protect 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 legislature and crafting legislation; acting as a government watchdog and filing comments on proposed rulings; educating the public, press, and decision-makers on integrative medicine; initiating legal activities and joining and forming significant coalitions.
About the Alliance for Natural Health (ANH)
http://www.anhcampaign.org/
The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to protect and promote natural healthcare, using the principles of good science and good law.
The ANH’s overriding goal is to help develop appropriate legal and scientific frameworks for the development of sustainable approaches to healthcare. As in the fields of energy and agriculture, sustainable healthcare invariably requires use of natural products which are inherently compatible with human biochemistry and physiology. Within this setting, consumers and health professionals should be able to make informed choices about a wide range of health options, and in particular those that relate to diet, lifestyle, traditional medicinal and non-drug-based or natural therapies, so that they may experience their benefits to the full while avoiding unnecessary risks.
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