Wednesday, December 23, 2009
Are Mothers-To-Be Unwittingly Passing BPH and other chemicals to their Unborn babies? And When Will the FDA Wake Up To These Dangers?
* Children exposed to both tobacco smoke and lead are 800 percent more likely to develop ADHD.
* Childhood exposure to lead can cause permanent brain damage to those genetically susceptible. No region of the brain is spared.
* Adults with an average age of 21 who had been enrolled as infants in the Cincinnati Lead Study had IQ deficiencies as well as histories of juvenile delinquency and criminal arrests.
* Baby boys whose mothers used insect repellants in the first three months of pregnancy were at an increased risk of a birth defect called hypospadias (the urethra, which carries urine from the bladder to the opening of the penis, is shortened).
* A study of pregnant women by the Washington Toxics Coalition learned that:
o Every woman tested had been exposed to Bisphenol A (BPA), which is linked to a number of adverse health effects. BPA has been found in the lining of nearly every kind of food container, baby bottles, dental sealants and composite fillings, among other products.
o Every woman tested had been exposed to at least two — and in some cases, to as many as four — perfluorinated chemicals. Known as Teflon chemicals, these are used in manufacturing nonstick cookware.
o Every woman had been exposed to mercury, which is known to harm the development of the brain in the unborn.
o Every woman had been exposed to at least four phthalates, which are linked to adverse health effects. Phthalates are used to make fragrances last longer and also to soften plastic in personal-care products, shower curtains, baby toys, etc.
The Seattle Post Globe published a story about one mother who took part in the Washington Toxics Coalition study. Trained as a midwife, while pregnant she walked a 3-mile trail twice a week, swam weekly, took prenatal yoga classes, tried to eat mostly organic foods and avoided any scented lotions or other personal-care products. And yet, she rated the worst among the women tested for Teflon chemicals. An advocate of breast-feeding, she now worries that while breast-feeding to insure optimal nutrition for her infant son, she will pass chemicals along to him in her breast milk as she did, unwittingly, through her placenta.
Johns Hopkins University’s study of cord blood samples from 20 newborns revealed hundreds of chemicals, this from cord blood most of us would expect to be uncontaminated. With only about 200 of the 80,000 chemicals in our environment having been tested for their effects on humans, the American population is unknowingly taking part in an experiment. Dr. Phil Landrigan of Mt. Sinai School of Medicine has warned the medical community that 1 in 6 American children is now behavior- or learning-disabled because of exposure to chemicals. To add to this gloomy picture, studies have shown that genes are turned on or off by environmental factors, so future generations will also be impacted.
All children deserve the best protection we can provide, but the government is failing to shield our most vulnerable population — the unborn — from chemicals in the environment.
British consumers were amazed to learn from a report released by the British Royal Society that nearly two-thirds of the soy imported into the United Kingdom is genetically engineered. The majority of Brits and Americans are totally unaware that they are buying and eating foods made from GMO crops.
There has been no long-term testing of the impact genetically engineered crops have on humans or on the environment. We simply don’t know if the recent increases in allergies, asthma and other diseases that affect the immune system are related to the consumption of foods from GMO crops. The effect of GMO foods on our genetic map and the genes of future generations remains a mystery. The phenomenon of fish changing sex (among other abnormalities in wildlife reproduction) may or may not be related to the growing of GMO crops on U.S. farmlands. But it has been proven that GMO crops have modified traditional maize in Mexico.
A joint report from the Organic Center, the Union for Concerned Scientists and the Center for Food Safety reveals that the adoption of genetically engineered cotton, soy and corn has simultaneously increased the use of pesticides in the United States. What’s the connection? Large numbers of farmers are now raising corn, soy and cotton that have been genetically engineered to tolerate being doused with more and more weed killer. The first 13 years of commercial use of GMO crops have resulted in the overall use of pesticides on U.S. farms swelling by 318 million pounds.
Accelerated use of herbicides has caused super weeds to emerge, weeds resistant to pesticides. Because super weeds cost more to control, farmers face greater expenses in the long run. Add to this the fact that we simply don’t know the ultimate effect of super weeds on plant and wildlife.
The Organic Center predicts that in 2010, GMO corn seed prices could be as much as three times higher than prices for conventional corn seed. GMO soy seed prices are expected to be 42 percent higher than the original 1996 GMO soy. The medical toll remains unknown.
In his letter to the medical schools, Grassley asked:
* What is your institution doing about professors who engage in ghostwriting? and
* How does ghostwriting differ from plagiarism by students?
He also asked if these institutions have written policies regarding ghostwriting and how they respond to allegations that faculty members have failed to disclose funds received from drug and medical-device firms when drafting manuscripts for publication. Kudos to Sen. Grassley for bird-dogging shoddy research and dishonest journalism!
In response, Andrew Shao, Ph.D., vice president of scientific and regulatory affairs at CRN, declared: “The real headline of this study should be that smoking increases the risk of lung cancer…” . Daniel Fabricant, Ph.D., NPA’s vice president of scientific and regulatory affairs, said: “[T]wo flawed studies are combined to yield one larger flawed study. This does not seem to be in the best interest of medical science or public health”.
Among the numerous flaws in the research are:
* Both of the trials in this study were designed to assess the effects of folic acid and B12 on cardiovascular disease, not on cancer.
* Between 2001 and 2005, as people started taking folic acid, the United States actually saw a decrease in cases of cancer. According to CRN, “It is inappropriate to reach firm conclusions based on such limited data, especially in the face of vast evidence showing benefit for folic acid supplementation.”
* Most of the subjects in both trials were taking beta-blockers and statins; some were taking ACE inhibitors and diuretics. The study fails to analyze how these combinations of drugs relate to the risk of cancer.
* Design flaws caused one of the two trials to be terminated early.
* The factorial design of the other trial may have been too complex.
Friday, December 18, 2009
PRESS RELEASE – for immediate release
18th DECEMBER 2009
Two leading natural health campaign organisations are formally merging as of today. The Alliance for Natural Health (ANH), based in Dorking, UK, and the American Association for Health Freedom (AAHF), of Washington DC, have merged to form the Alliance for Natural Health International (ANH International). The new organisation is headed up by internationally acclaimed scientist and activist, Dr Robert Verkerk. The organisation’s headquarters will be in Dorking, UK, which will remain the base for ANH International’s European activities, now to be conducted through ANH-Europe. The Alliance for Natural Health USA (ANH-USA), under the leadership of attorney Gretchen DuBeau, will continue to operate out of its Washington DC base, although its activities will be closely coordinated with that of ANH International. The merger joins two powerful, results-orientated natural health organisations that have long advocated for natural and integrative medicine.
Dr Verkerk and his co-workers at ANH-International have been at the forefront of moves to reduce the impact of the increasingly far-reaching and stringent European regulatory system. This system threatens to decimate clinical nutrition, nutritional therapy, non-European healthcare traditions such as Traditional Chinese Medicine and Ayurveda as well as the leading-edge of the health food sector across the 27 Member States of Europe. European regulation is also acting as a key regulatory template influencing many countries around the world, as well as global standards and guidelines for food products issued through the Codex Alimentarius Commission. The ANH has pioneered the use of ‘good science’ and ‘good law’ as the key principles in establishing a legal and scientific framework appropriate to the continued and expanded use of natural and sustainable approaches to healthcare.
Known for its longstanding efforts to protect integrative practitioners from unjust prosecution for utilising natural healing modalities and ensuring consumers have continued access to the natural healthcare options of their choice, ANH-USA brings an arsenal of lobbyists and more than 50,000 advocates dedicated to shifting the medical paradigm from an exclusive focus on surgery, drugs and other conventional techniques to an “integrative” approach incorporating food, dietary supplements and lifestyle changes.
“United we are stronger”, said Dr Robert Verkerk. “Europe has one of the most restrictive systems which we badly need to liberalise,” continued Dr Verkerk, “while the US represents one of the most liberal systems, which we must ensure is not lost. Together, we handle both sides of the issue. Many consumers and natural health advocates have criticised the lack of cooperation among natural health campaigners. We hope today marks a permanent change.”
Gretchen DuBeau, executive director of ANH-USA, commented, “We are thrilled about the merger. The opportunity to join forces with a top-notch, international natural health organisation increases our strength in moving towards a sustainable, integrative medical model.”
ANH International is committed to sustainable approaches to healthcare. It strongly believes the existing orthodox medical paradigm, based around the over-use and abuse of pharmaceutical drugs, can no longer be countenanced. Its lack of respect for biological principles, born out by poor efficacy and huge costs in terms of side effects, is just one expression of this.
According to ANH International, preventative medicine is too often incorrectly defined by the use of increasing amounts of drugs, earlier and earlier in life, even in childhood. The concept of sustainable healthcare is about genuine prevention, particularly chronic disease prevention. Chronic diseases represent the single greatest burden on healthcare systems around the world and it is well accepted that they are largely preventable through dietary and lifestyle changes, rather than the use of drugs.
Drawing on the legal, scientific and policy expertise of its US and European offices, as well as its affiliates around the world, ANH International will work tirelessly and with even greater effectiveness to help stimulate a fundamental shift in the orthodox western healthcare paradigm. The new paradigm, built on the principles of sustainability, needs to work harmoniously with biological systems, rather than against them.
Given the imminent threats to natural health in many parts of the world, and the urgency of required action, ANH-International, and its two regional offices, is looking to expand significantly its reach among consumers, practitioners and companies in the natural health field. New or substantially revised campaign websites have been launched which hope to facilitate this process. Companies or practitioners, or even volunteer members of the public, wishing to collaborate with any of the organiations should contact their nearest regional office.
For further information, please contact Meleni Aldridge, Executive Coordinator, ANH-International; ph: +44 (0)1306 646 600, email: firstname.lastname@example.org or Gretchen DuBeau, Executive Director, ANH-USA; ph: +1 202 467 1988, email: email@example.com.
About the Alliance for Natural Health International?
The Alliance for Natural Health International (ANH-Intl) represents an international non-governmental organisation dedicated to promoting natural and sustainable approaches to healthcare. It upholds that the integrative medicine and functional medicine models, as well as many traditional healthcare systems that have evolved over millennia, are more appropriate means of dealing with today’s health challenges than the current dominant western medicine model, which is over-reliant on the use of pharmaceutical drugs. The ANH is working collaboratively to help facilitate the development of scientific and legal frameworks appropriate to natural healthcare.
Find out more
Tuesday, December 01, 2009
For the many Americans who choose to purchase a high-deductible, major medical plan but with the opportunity to put aside tax-free dollars to be used toward deductibles or other medical expenses, maintaining access to HSAs is clearly an issue of freedom of choice issue. HSAs also make healthcare less susceptible to political control. Tell Sen. Reid to leave HSAs alone!
Before the passage of healthcare reform tackling the issue of pharmaceutical companies’ sky-high profits, the drug industry has been raising prices.
Four House leaders (Charles B. Rangel, D-N.Y.; Henry A. Waxman, D-Calif.; Pete Stark, D-Calif.; John Lewis, D-Ga.) and one senator (Bill Nelson D-Fla.) have called for two separate investigations into drug-company pricing.
“They are trying to influence the people who have the power,” states Josh Israel of the Center for Public Integrity. Now is the time to make your voice heard by Congress. Your voice is priceless when raised to elected officials debating key issues, including healthcare freedom of choice.
Add to this the fact that researchers at Harvard University, publishing in The American Journal of Medicine, wrote that administrative costs rose when hospitals switched to EMRs. Lead author Dr. David Himmelstein stated: “Our study finds that hospital computerization hasn’t saved a dime, nor has it improved administrative efficiency.”
Has anyone sent a copy of this journal to the members of Congress?
The CER Commission established by the bill would determine areas of national medical priority and commission research to evaluate the clinical effectiveness of various treatments for particular conditions. The stated intent is to determine the best treatments and then provide this information to policymakers, clinicians, healthcare payers, and the public to better inform healthcare decision making.
First established in the stimulus bill, CER is controversial for good reason. Any such government body will very likely be captured by special interests such as drug companies, medical equipment manufacturers, or the AMA. It may also lead to a one-size fits all system of medicine. Knowing that the CER program is a non-negotiable item for both President Obama and Congress, we have been working to ensure that any system created to fund and evaluate medical treatments will at the very least provide an even playing field for integrative medicine. In a best case, CER would also fund research about non-patentable and thus largely ignored natural treatments.
Thanks to Senators Mikulski and Conrad, along with other friends, the senate healthcare bill now requires that the CER board include at least one integrative healthcare practitioner along with healthcare consumers, physicians, private payers, and pharmaceutical and diagnostic manufacturers. It also includes, as appropriate, experts in integrative health and primary prevention strategies on the CER advisory panel. This marks the first inclusion of integrative medicine in any federally designed program. While we have miles to go, these are powerful first steps.
Other important provisions in the senate healthcare bill include the following:
Inclusion of a “Sense of the Senate” that the Congressional Budget Office (CBO) should restructure their scoring of integrative medicine. Currently, when scoring legislation to determine the cost of a bill, the CBO assumes the cost of preventive services are realized initially and are not offset by later savings. For example, nutritional counseling is seen solely as a cost, not as a way to prevent and control diabetes, thereby saving billions. Although Sense of the Senate expresses the Senate’s opinion rather than creating law, this is a strong statement about the need to restructure CBO accounting, and one we hope the CBO will seriously consider.
Establishment of a National Prevention, Health Promotion, and Public Health Council to develop a national preventive and integrative healthcare strategy. The council will be advised by a group of experts required to include diverse health professionals including integrative health practitioners who have expertise in preventive medicine. The national plan also mandates a list of national priorities on health promotion to address lifestyle behavior modification including proper nutrition. Again, the senate has mandated the inclusion of integrative health practitioners in yet another program that, should the bill pass in this form, will strongly influence the direction of our health system. We are also pleased to see true prevention, such as nutrition, included in the list of priorities.
Group health plans and issuers offering group or individual health insurance coverage are required to report on whether coverage benefits under healthcare plans includes wellness and health promotion activities. The bill states that wellness programs may include personalized services that may be geared toward smoking cessation, weight management, stress management, physical fitness, heart disease prevention, healthy lifestyle support, and diabetes prevention. While there is no requirement these preventive services be covered by healthcare insurance, the suggested areas of inclusion within wellness coverage is a step in the right direction.
We wish these provisions were all there is to talk about in the Senate bill. Despite the victory described above, there are still many really bad features of the bill, features that we have discussed before, including:
Electronic health records – All qualified health-benefits plans are required to use electronic health records set up in such a way as to gut your privacy and jeopardize doctors’ use of integrative therapies. The plan also includes unique health plan identifiers - each of us will have a cradle to grave unique ID number that will track medical history. Thanks to the electronic health records mandate, this information will be available with the click of a mouse.
Cost-Sharing is prohibited for preventive services. A strict reading of the definition of “cost-sharing” may prevent out-of-pocket payment for medical services that are supposedly “available” under qualifying health insurance. This means that you may not be able to pay privately for what you want but is not specifically covered under the policy. This kind of restriction already exists with Medicare. If you want more than Medicare provides, it is illegal for your Medicare doctor to provide it.
Mandated healthcare coverage – You can no longer choose the healthcare options that work best for you. You must now purchase coverage that is defined by the government. Individuals who do not have or buy this qualifying coverage will be taxed on their annual tax return. And, of course, those that fail to pay their taxes will go to jail.
Catastrophic and similar packages will no longer be available to anyone over the age of 30. These packages have enabled people to buy natural healthcare on their own while still being covered for major medical. This vital option will disappear for many of us.
Cap on Flex-Spending Account (FSA) contributions at $2,500 - Currently, the contribution level is unlimited. This is another way to make natural medicine more expensive for consumers.
Medicine Cabinet Tax - Americans would no longer be able to purchase over-the-counter medicines with their FSA, Health Savings Account (HSA) or Health Reimbursement Arrangement (HRA).
Increase in the non-qualified HSA distribution penalty from 10 percent to 20 percent. This makes HSAs less attractive and paves the way for HSA pre-verification.
Likely long-run elimination of HSAs – The Senate bill is confusing about HSAs, possibly intentionally so. The real intent may be for them to disappear completely because they won’t be able to comply with mandated policy requirements.
The Senate bill also uses various “smoke and mirrors” ways of appearing to pay for itself, but we will leave that part of the story for the financial experts.
The U.S. Senate is scheduled to begin debate on the merged healthcare bill this week. As always, we’ll keep you updated with the latest developments and opportunities to take action and make your voice heard in the healthcare debate!
Thursday, November 19, 2009
Lisa Lundy — public speaker, health and wellness expert and author of The Super Allergy Girl Gluten-Free, Casein-Free, Nut-Free Allergy & Celiac Cookbook is a strong supporter of ANH-US “Consumers who want to get the real deal on health care issues can rely on ANH-US for representing consumer concerns. They have a wonderful newsletter that highlights not only the important health care issues, but also the small actions consumers can take that will make a difference,” Lundy stated.
Since 1992, the Alliance for Natural Health US (ANH-US) has advocated for practitioners and consumers. Over the years, the organization’s name has changed a few times, but its mission has never wavered — to protect the practitioner’s right to practice and the consumer’s right to choose.
ANH-US, www.healthfreedom.net, has grown to be an international voice dedicated to promoting sustainable healthcare and freedom of choice through good science and good law. The organization focuses on shifting the medical paradigm from an exclusive focus on surgery, drugs and other conventional techniques to an “integrative” approach incorporating food, dietary supplements and lifestyle changes — a model that improves health and quality of life while reducing the costs of healthcare to a sustainable level.
Under federal regulations, producers of dietary supplements are prohibited from making any “health claims” for their products unless pre-approved by FDA. Even scientifically proven health benefits are restricted. ANH-US, which believes consumers have the right to receive information and make informed decisions for themselves without government censorship, is actively working to allow manufacturers of dietary supplements to communicate the scientifically proven benefits of their products directly to the consumer.
ANH-US is a 501(c)4 nonprofit organization with headquarters in Washington, D.C. to protect the rights 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.
“It was the freedom to choose both a physician and a treatment that saved the life of my youngest child” Lundy said. Lundy’s daughter had a life-threatening medical condition - the inability to absorb essential vitamins and nutrients from her food – and a dysfunctional immune system that left her young child living like a modern day bubble child. Thanks to a good medical team, a variety of medical treatments and other interventions and over $100,000 in out-of-pocket medical expenses, Lundy’s daughter, Anne who will turn 8 years old soon, is almost completely well. Lundy, who has no formal relationship or ties to ANH-US, has been recommending them for several years. It is the place she turns to for finding out what is happening in health care from a consumer and freedom perspective.
NOTES TO THE EDITOR: About the Alliance for Natural Health US (ANH-US): www.anhus.org
ANH-US is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. Formerly known as the American Association for Health Freedom, ANH-US 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
It is true that you won't find Sections 7201 and 7203 in the House healthcare bill. End of story? No. When Nancy Pelosi was asked about the jail terms, she did not deny them. What was going on here? The explanation is as follows. Under the House bill, if you don't buy the particular insurance policy mandated by the government, there is a financial penalty. The legislative language of the bill quite intentionally describes this financial penalty as a tax. Why is that important? Because under sections 7201 and 7203 of the tax code, you can go to jail for not paying a tax. The sponsors of the House bill thus created a jail penalty for non-payment without having to include this specifically in the bill.
Is this the right interpretation? That question was addressed to the Congressional Tax Committee; the Committee’s written response confirmed it. If you don't buy the mandated insurance and you don't pay the tax, you can be put it jail for up to five years. Supporters of the bill still claim that in this case you won't be jailed for not buying the policy. You will be jailed for not paying a tax. Perhaps we can all agree on this language--not buying mandated insurance can lead to jail. And that is exactly what Nancy Pelosi intended.
The truth is, millions of American use integrative medicine and are generally satisfied with the results. Most pay out-of-pocket for these services. If it works for them, what more could taxpayer dollars do to ascertain the effectiveness of integrative medicine?
Americans vote daily with their pocketbooks by buying and using integrative therapies, therapies that are the basis of traditional Chinese and Ayurvedic medicines, disciplines with more than 5,000 years of recorded success. Consumers also know that conventional medicine comes with a significant risk of errors, side effects (even resulting from correctly prescribed drugs), contraindications and hospital-acquired infections. For example, consumers understand that chemotherapy may help their cancer but its risks could outweigh the benefits.
Knowing this, Mimi Guarneri, M.D., medical director of Scripps Center for Integrative Medicine in La Jolla, Calif., has said: “It’s … unreasonable to argue that alternative therapies must be studied as thoroughly as a lot of mainstream medical practices. The research should be as strong as a therapy's potential for risks.” In other words: Conventional medicine may, in fact, require more research than CAM, as its potential for risk can be much greater than that of integrative therapies.
Coca-Cola spokeswoman Diana Ciarlante said the criticism leveled at this deal “misses the point of the partnership, which is to provide education based on sound science,” but consumers are not ignorant. They get that sponsors spend dollars to promote their products. The AMA retreated from a deal with Sunbeam Corp., whereby it would endorse Sunbeam’s “Health at Home” products without having tested them; and the American Heart Association suffered a backlash when word spread that companies could buy a heart-check seal of approval for products that were anything but heart-healthy.
Obesity, cancer and diabetes have profound effects on quality of life, and their financial cost — for individuals and the entire healthcare system — is staggering. These three conditions exemplify how lifestyle choices affect genetic expression: that is, we can activate or deactivate genes that determine why one person gets cancer or diabetes and somebody else does not. Healthcare reform without a focus on wellness does little to address why a land of plenty is so ineffective in addressing obesity, cancer and diabetes. As Pulse of Health Freedom pointed out in an article dated Oct. 20, 2009, our dollars are ill spent if we fail to champion medicine that can truly prevent and reverse conditions stemming from lifestyle choices. On the bright side, legislation like S. 1640 (the Take Back Your Health Act of 2009) does support lifestyle therapies that have significant impacts on obesity, cancer and diabetes — diseases that drain us financially while impairing quality of life.
As Weeks points out on The Integrator Blog, NCCAM has moved away from the congressional mandate by which it was established in 1998. Many believe it is time for NCCAM to return to that mandate: i.e., to "study the integration of alternative treatment, diagnostic and prevention systems, modalities, and disciplines with the practice of conventional medicine as a complement to such medicine and into health care delivery systems in the United States”.
Thanks to the amendment, the bill no longer requires the development of a plan “to harmonize requirements under the Codex Alimentarius”. Now the bill calls for a plan “on whether and how to harmonize requirements under the Codex Alimentarius" (§306, p. 116).
As will be evident, we have not succeeded in eliminating the Codex provision entirely. This is because the Senate wants to keep open the option of adopting some Codex rules while protecting dietary supplements from the harsh European regime. The language of the amendment means that we will have to remain very vigilant and probably refight the same battle over again in the future. But at least the US has avoided committing itself to the concept of Codex harmonization. And this is a very important legislative victory.
US law on dietary supplements is currently governed by The Dietary Supplement Health and Education Act (DSHEA). Senators Harkin and Hatch, strong supporters of natural health and the use of supplements, have assured us that asking the FDA to review Codex standards will not be allowed to threaten DSHEA. This is vital of course because of the FDA’s well known hostility to dietary supplements.
In his opening remarks in the mark up, Senator Harkin, chair of the HELP Committee, emphasized this message of protecting DSHEA. As the Senate moves forward with the legislation, Senators Harkin and Hatch have also promised to see what else can be done to make absolutely clear that none of its provisions will impact our access to high quality, potent dietary supplements.
There is more good news. The Senate Food Safety bill has eliminated many of the provisions in the House bill that most troubled us. However, we can’t forget that after the Senate passes it’s version of the Food Safety bill, the House and Senate will go to conference. There they will work behind closed doors to combine the Senate and House versions of the bill. This means that the worst provisions of the House bill could return.
Perhaps the most troubling aspect of the House bill is the increase in jail sentences (from three to ten years) and fines (to $100,000 for individuals and $7.5 million for corporations) for "adulterating" or "misbranding" food or supplements. If a food or supplement company cites scientific, peer-reviewed studies in support of a health benefit of a product, this would be deemed by the FDA to be misbranding and could trigger the penalties. Likewise, as defined in the current Good Manufacturing Practices, even minor paperwork violations could, per the FDA, represent adulteration and lead to draconian fines or jail sentences. These penalties are particularly worrying because of the FDA’s well established record of intimidation and legal harassment of innocent parties. It often seems that the FDA’s primary concern is to protect drugs from competition. Drug companies of course pay a significant portion of the FDA’s salaries.
The House bill also imposes new fees on food operations of all sizes, from the very smallest to the largest; imposes record keeping, hazard analysis, food safety plans, and more on farms as well as businesses, small and large; gives the FDA control of farming standards and practices, despite the Agency’s ignorance of these matters; permits the FDA to conduct random, warrantless searches; and ignores the recommendations of a government report on the failings of the FDA and the urgent need for reform at the Agency.
We will continue to work with members of Congress to ensure that the final version of the Food Safety bill does not compromise your access to healthy, natural and sustainable healthcare options, including high quality food and food supplements.
We’ll keep you updated!
Friday, November 13, 2009
Dr Robert Verkerk, our scientific director, told NutraIngredients.com that although government-led efforts to accumulate reports of adverse events through practitioners, health stores and other suppliers of supplements is in principle sound, there is great potential for such data to be misused:
“We have seen both in Europe and the USA, numerous cases where food supplements have been flagged as causative agents of particular adverse effects when further scrutiny demonstrates they were simply among large lists of products, often including medications and even alcohol and recreational drugs, consumed. It is utterly misleading to misrepresent the role of food supplements in such instances and the only way around the problem is to ensure absolute transparency in reporting, access to medical records and in the drawing of conclusions as to the potential contributory role of specific food supplements.”
Although very few adverse events following the use of dietary supplements are reported to the FDA, too often media frenzy focuses on the use of supplements when, in fact, other factors — including the use of medications and recreational substances, such as alcohol — have a more profound role to play. Kudos to Dr. Verkerk!
On October 26, 2009, the Government Accountability Office (GAO) released a report indicating the FDA has often allowed drugs to remain on the market after follow-up studies showed a lack of any benefit. The “fast-track drug-approval process,” which the FDA instituted in 1992, was the ready-set-go! for drugs to be rushed to market on the basis of meager, preliminary laboratory study. For example, Viagra, tested in just two studies on 200 volunteers, was approved by the FDA and soon prescribed to millions of patients. Adverse reactions and deaths associated with the use of the drug were noted only when Viagra was prescribed to many more patients than those who had participated in the original clinical trials. A number of drugs designed to treat cancer and HIV were approved in a similar fast-track fashion with the proviso that the manufacturers conduct follow-up trials to document their drugs’ effectiveness. And yet, the FDA often fails to police this requirement. Equally distressing is the fact that FDA, rather than insisting on independent, third-party studies, uses the manufacturer’s own data to determine effectiveness.
Congressional investigators have revealed that the federal law directing the FDA to bar researchers already convicted of fraud from engaging in further research is all but ignored. A congressional report released October 22, 2009, noted that the FDA pays “so little attention to its responsibilities to ban researchers convicted of fraud and is so disorganized about carrying them out that its actions take an average of four years to complete”. The GAO’s analysis of 18 proceedings regarding researchers convicted of fraud found that the FDA took between one and 11 years to complete the process. Congressman Joe Barton, R-Texas, has promised to introduce legislation to give the FDA more power to ban convicted researchers. Why is there no pressure on the agency to enforce existing federal law?
The standardization of food-labeling by the FDA is all over the news. For example, USA Today has publicized criticism leveled at the nation’s largest cereal maker, Kellogg’s, whose box of Cocoa Krispies trumpets: “Now helps support your child’s IMMUNITY”. A careful review of the label reveals this claim to be misleading, even fraudulent, because Kellogg’s is referring not to the cereal but to an added ingredient. Kelly Brownell, Ph.D., of Yale University’s Rudd Center for Food Policy and Obesity, notes: “By their logic, you can spray vitamins on a pile of leaves and it will boost immunity.”
Shame on the FDA for being so lax when it comes to important issues affecting consumer safety! Have you signed the petition calling for reform of the FDA? If not, please do so now.
In order to have an accurate understanding of the two bills, we dissected both and the following is our summary:
- S2028 is an incredibly broad piece of legislation that:
- does not define what constitutes a ‘public health emergency;
- strips the citizens of Massachusetts of core constitutional rights such as your right to be free from unreasonable searches, your right to protect your property, and your right to privacy; and
- authorizes the Commissioner to ‘take immediate possession from any source’ anti-toxins, serums, vaccines, immunizing agents, antibiotics … necessary to respond to the emergency.'
- H4275 is more reasonable and includes provisions that protect individual rights.
- Commissioner needs Governor approval “to take action and incur such liabilities as the commissioner may consider necessary for the maintenance of public health and the prevention of disease.”
- A ‘public health emergency’ is defined;
- Prior to administering a vaccination or medication, a medical professional or volunteer shall inform the consumer of any possible side effects. If no side effects are known at the time of the administration of the vaccination or medication, the consumer shall be informed of that as well;” and
- a judicial review process for isolation and quarantine orders.
To learn more about these two pieces of legislation download our comparative analysis: Massachusetts_Comparative_Analysis
If you are a resident of Massachusetts, Contact your Representative to ensure your constitutional rights are protected.
The heft of the bill and its unveiling shortly before the vote testify to the deal-making behind the scenes. As the New York Times says: “The medical industry grumbles, but it stands to gain”. It has become clear to consumers that everyone’s interest but theirs are being leveraged through the federal legislature. No wonder Congress’s own healthcare is exempt from the bill.
Former NY Lt. Governor Betsy McCaughey has been reading the bill’s fine print. She reports in a Wall Street Journal article: “While the bill will slash Medicare funding, it will also direct billions of dollars to numerous inner-city social work groups with vague standards of accountability.” What are these groups supposed to do with the billions? Counsel people about the new Federal system?
McCaughey goes on: Section 223 of HR 3962 requires an individual making $44,000 before taxes to pay 17% of his pre-tax income for mandated insurance. Higher earners will be required to pay 20%. How these mandates differ from taxes escapes us, and they are big mandates hitting the middle class.
Section 202 also takes away your freedom to choose. You are required to enroll in a “qualified plan,” The government defines what qualified means and will have lots of help on this from special interests. Natural health and integrative medicine do not have much clout in Congress.
If you have a business to make a living for you and those you employ, section 412 states you must pay 72.5% of the cost for your staff or incur a 8% payroll tax.
Section 222 provides Medicare recipients the “right” to language translation services at all times without co-pay. What about the rights of those who pay taxes to pay for all this?
Section 1302 moves Medicare away from fee for service to a strict managed care model. Section 1158-60 says that Medicare will stop paying more in expensive places. The payment in New York will not be higher than in rural areas.
Other sections require doctors to share your private records with numerous other parties.
The healthcare debate now moves to the Senate. We will keep you posted and ask for your help in shaping that vote.
Friday, November 06, 2009
The preparation for the weekly Pulse of Health Freedom requires hours of researching news-wire services, newspapers, Web sites and other publications. A review of the Associated Press health articles on one day, 10/26/09, led to two articles with attention-grabbing titles, “’Bioidenticals’ not FDA-approved, contain estrogen” and “Somers’ new target: conventional cancer treatment”. Both articles were preceded by the following editor’s note:
“Ten years and $2.5 billion in research have found no cures from alternative medicine. Yet these mostly unproven treatments are now mainstream and used by more than a third of all Americans. This is one in an occasional series examining their use and potential risks.”
Separating news from mere opinion is important for every American who seeks to make healthcare choices based upon objective information.
In related news, the “industry-funded” (code for “You can buy the Smart Choice seal”) labeling program was halted 10/23/09 after the FDA warned it was examining the program’s nutritional claims and would take action against false or misleading assertions. The American Heart Association was criticized when manufacturers paid a fee for the heart-check label, which was sometimes applied to foods less than rich in nutrients crucial for heart health.
The FDA hopes to use the approach tested in the United Kingdom, where the British government established criteria for food labeling that were then implemented voluntarily by grocery stores. However, in the United Kingdom there is a consistent public-health message that dietary choices can adversely affect health — as opposed to the United States, where the media bristle with ads pushing sponsors’ products.
We have previously written about the ramifications of the economic stimulus bills that became law in February 2009. Putting aside the economic and security consequences of adding to the nation’s debt, let’s focus on the $1.1 billion for a Comparative Effectiveness Research (CER) program, designed to determine which healthcare treatment options are most effective — and most cost-effective. According to CER supporters, an immediate benefit would be cost savings for government-funded insurance programs. By determining which treatments are most effective, the less effective — and often more expensive — options would (theoretically) no longer be covered by government insurance plans, saving taxpayers money. But as we all know, the devil will be in the details.
Norbert Gleicher, M.D., visiting professor at Yale University School of Medicine, and president and medical director of the Center for Human Reproduction in New York City, wrote in the 10/19/09 Wall Street Journal that “the idea of inserting a government panel between patients and physicians remains contentious and with good reason”. Relating a personal story, Dr. Gleicher said that he recommended HRT to his own mother, to address her risk of osteoporosis. After all, the medical literature of that time advocated HRT for reducing the risk of bone thinning. Happily, Gleicher’s mother’s long-standing doctor did not advise that she use HRT. This turned out to be lifesaving, as she was later diagnosed with breast cancer, a contraindication for HRT.
According to Gleicher, most published studies are written by academics with little practical experience, a policy that allows university-based doctors who have limited patient contact to determine “appropriate clinical care.” He also mentions the bias of medical journals’ policy of peer review, a system he believes is rarely free of conflicts and only rarely objective. Quoting Albert Einstein, Gleicher says: “A foolish faith in authority is the worst enemy of truth.”
After listening to an earnest young family practitioner, just three months out of residency, repeat the old saw “We need more studies before we recommend antioxidants,” it was refreshing to hear a wise, local general practitioner of many years standing remind me, “Speak with a doctor/medical student at the end of the first year in school. They have just completed their study of anatomy, physiology and biochemistry. Nutritional medicine makes sense to them at that point. The following three years, and subsequent internship and residency schools, teach doctors to push prescriptions and procedures.” In a nation overburdened with chronic illness related to unwise lifestyle choices, prescriptions and procedures do little to address obesity, diabetes, heart disease, arthritis and cancer.
Dr. Gleicher is right in saying, “Expert panels would only slow medical progress and delay rejection of false prophecies and dogmas.”
A report released 10/26/09 by Thomson Reuters, parent company of the Reuters news service, stated that the current U.S. health system wastes between $505 billion and $800 billion a year, one-third of our current healthcare expenditure. The report cites the following as sources of wasteful spending:
Overuse of antibiotics and lab tests to protect against malpractice lawsuits (Pennsylvania State University estimates that as much as 91 percent of our nation’s healthcare expenditures are related to defensive medicine);
Fraud, which may be as high as $200 billion annually in Medicare claims alone;
Administrative inefficiency and redundant paperwork;
Preventable conditions, such as uncontrolled diabetes.
The report states that the average U.S. hospital spends one-fourth of its budget on billing and administration (twice what is spent in Canada). Eight hours per week and 1.66 clerical staff, on average, are needed for each doctor, again far more than is the case in Canada.
On 10/22/09 Health and Human Services Secretary Kathleen Sebelius announced a $17-million initiative to address HAI or hospital-acquired infections. Thanks to concerned citizens, such as former Lt. Gov. Betsy McCaughey of New York, whose Committee to Reduce Infection Deaths was established in 2004, attention has been drawn to the fact that there are 2 million cases of HAI each year, resulting in 100,000 deaths and an additional $33 billion in healthcare costs (www.hospitalinfection.org). That is a true national emergency requiring immediate action, so why doesn’t every U.S. hospital adopt the proven techniques developed by the Committee to Reduce Infection Deaths? President Bush’s administration took a huge step forward by stating Medicare would no longer pay for the costs of hospital-acquired infections. Let’s enforce this immediately.
Hannah Wunsch, M.D., of Columbia University Medical Center compared 493,054 patients in the United Kingdom with 704,028 patients from seven U.S. states, all of whom died in 2001. Roughly half of all U.S. hospital deaths involved ICU care, whereas only one in 10 of the British patients had received ICU care prior to dying. As Wunsch said, “What do we get with all the intensive care we’re giving people?” And Wunsch is an intensive-care doctor!
One of the key questions about the bill is its cost. According to the November 2, 2009, issue of the Wall Street Journal, the estimated gross cost of the Democratic House legislation is $1.055 trillion over 10 years. Such estimates in the past have been low—partly because they do not take into account the expansion of healthcare demand that follows an increase in government subsidies. When demand rises while supply stays the same or falls, prices increase, often dramatically.
Before we get to the main problems of the House bill, apart from cost, let’s take a moment to note some positive features. The main thing that is positive about it is a new regard for the concept of wellness and prevention. Even this is far from perfect. These terms are not defined as they should be. Without the right definitions, prevention can be turned into a program of more and more invasive tests and drugs for younger and younger people. Here is how prevention is specifically addressed in the bill:
Prevention: Wellness program grants for small employers (Section 112)
Grants may equal up to 50 percent of the amount of money an employer spends on qualified wellness programs. A program must include three of the following:
2) Engagement (i.e., wellness-program components on site)
3) Behavioral change (supportive programs, self-help materials, etc.) linked to nutrition, physical fitness, obesity, etc.
4) Supportive on-site component (i.e., nutritious food available on site)
A program may not be mandated for employees, must be based on current science and approved by the secretaries of HHS and Labor. A program may provide financial incentives for employees and must ensure that personal information remains private.
National Prevention and Wellness Strategy (Section 3121)
A plan will be developed that includes national priorities and utilizes evidence-based clinical and community prevention and wellness activities.
There will be a transparent public comment period designed to give special interests less opportunity to completely dominate.
Composition will include the heads of appropriate health agencies, federal departments, nonprofits and the Task Force on Clinical Preventive Services (see below).
Task Force on Clinical Preventive Services (Section 3131)
Under AHRQ (Agency for Healthcare Review and Quality), the task force shall review and update preventive services as supported by science.
Composition will include experts in related fields, such as disease prevention.
A stakeholders’ board will provide consultation. This board shall include consumers, payers, federal agencies, and both public and private groups with an interest in clinical prevention.
Task Force on Community Preventive Services (Section 3132)
This task force will be similarly constructed and operated as the Task Force on Clinical Preventive Services (see above). Its mission is to review community prevention services and disseminate evidence-based recommendations.
Research grants available to study prevention specifically (Section 3141)
Grant program to study whether subsidizing individual wellness choices is beneficial (Section 3143)
The program will focus on tobacco cessation and obesity. If incentives prove to be helpful, these shall be included in the Essential Benefits Healthcare Package (see below).
Grant program (to states) for delivery of community prevention and wellness programs (Section 3151)
Grants to promote healthy behaviors in medically underserved communities (Section 399V)
Areas of focus include poor nutrition, physical activity, tobacco use, mental-health problems and dangerous sexual behavior.
Community grant program specifically addressing obesity with nutrition and physical activity(Section 399w-1)
Nutrition labeling on menu items at chain restaurants and in vending machines (Section 2572)
Prevention: Essential Benefits (basic mandated healthcare package) includes preventive coverage (Section 222)
CDC-recommended vaccines and preventive measures rated A or B by the Task Force on Clinical Preventive Services shall be covered. Note that although nutrition counseling, for example, is covered for those who have indications toward certain disease (a positive step), they are the only consumers covered. Truly preventive medicine, including a focus on maintaining optimal health with diet, supplements, and exercise, is not covered.
Prevention covered for Medicare, Medicaid and CHIP plans defined as above.
Money available for preventive training in medical school (Section 2234)
Note: There is no definition of prevention.
Cost-Sharing is prohibited for preventive services.
The intent seems to be to ensure that consumers are not burdened with co-pays and deductibles for covered preventive services. The term “cost sharing” includes deductibles, coinsurance, copayments, and similar charges, but does not include premiums, balance billing amounts for non-network providers, or spending for non-covered services. (General Definitions) A strict reading of the definition of “cost-sharing” may prevent out-of-pocket payment for medical services otherwise covered by qualifying health insurance, as is already the case with Medicare. You may not be able to pay privately for your healthcare options of choice!
With regard to prevention, it is as if Congress has heard the music, but still can’t carry the tune. In other areas, Congress is not even hearing the music, for example in requiring but not protecting the privacy of personal electronic health records (EHR).
EHR – All qualified health-benefits plans are required to use electronic health records (Section 237)
Privacy is gutted and doctors’ use of integrative therapies may be jeopardized.
EHR – Study to determine how best to motivate small providers to use EHR (Section 263)
Concerns about the use of electronic medical/health records (as noted above).
If a practitioner participates in Medicare, they are automatically deemed to participate in public option unless they opt out. (Section 323)
This bill of course brings in a national insurance mandate. A mandate means that government must define health and healthcare and healthcare insurance policies. The problem is that government is not equipped to do these things. Healthcare is a discovery process and needs to keep changing based on new science and what people prefer. The bill specifically includes both:
Employer mandate (Section 413)
Employer must provide coverage or pay a tax equal to 8 percent of the average wages paid by the employer in lieu of coverage. Note that there is a sliding scale for the smallest employers, those with payrolls less than $750,000. Payrolls under $500,000 are exempted from taxes.
Individuals must purchase qualified health benefits through the state exchange system unless grandfathered in with existing coverage. There are three different levels from which to choose. Those who have difficulty paying can apply for credits. Note that employer-offered healthcare plans cannot be grandfathered, and that individual plans, although they can be grandfathered, must not be altered in any way. The public option will be offered through the state exchange system.
Individuals who do not have qualifying coverage will be taxed at 2.5 percent of their AGI divided by an amount specified by the IRS. (Section 59B)
Catastrophic and similar packages will no longer be available. These packages have enabled people to buy natural healthcare on their own while still being covered for major medical. This vital option will disappear.
Excise tax on the wealthy (Section 59c)
For those filing jointly, a modified AGI exceeding $1 million will be taxed at 5.4 percent. If filing separately, AGI exceeding $500,000 is taxed at 5.4 percent. The trouble with this plan is that money pulled into healthcare from outside healthcare will just drive up prices. As prices rise, the money will in effect disappear. And of course if new taxes are used for healthcare, they can’t be used for deficit reduction. Millionaires in the US control about 10% of the income. No amount of taxes on 10% of the income will pay for healthcare and reduce government deficits.
Comparative Effectiveness Research is supposed to ensure that healthcare money is not wasted. But how can government decide what is effective and what is not? Will government just listen to special interests?
Comparative Effectiveness Research (CER) is not a transparent process and doesn’t include representation of integrative medicine, subjecting the process to abuse by special interests
CER says that there must be a transparent process but does not specify public comment for all steps in the process. (This is required in the Senate finance bill.) Any entity can submit research, making it likely that companies with the most money will dominate.
Cap on Flex-Spending Account (FSA) contributions at $2,500 (Section 532)
Currently, the contribution level is unlimited. This is another way to make natural medicine more expensive for consumers.
Medicine Cabinet Tax (Section 531)
Americans would no longer be able to purchase over-the-counter medicines with their FSA, Health Savings Account (HSA) or Health Reimbursement Arrangement (HRA).
Increase in the non-qualified Health Savings Account (HSA) distribution penalty from 10 percent to 20 percent (Section 533)
This makes HSAs less attractive and paves the way for HSA pre-verification. In other words, “big brother” tells you how to use them.
School-based health clinics to include mental screening and mental-health treatment programs (Section 2511)
Prozac for those children deemed socially anxious is a likely outcome.
No child left unimmunized against influenza (Section 2524)
Grants to help ensure all young schoolchildren are immunized – through schools. Vaccine safety ignored.
Natural medicine along with the freedom for consumers to choose and practitioners to practice should not be a casualty of the current healthcare debate. Make sure your elected officials hear from you regarding this critical legislation. Let’s preserve healthcare freedom of choice at all costs.
Click here to take action NOW!
Tuesday, October 27, 2009
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.
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.
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.
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
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?
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
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.”
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
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.
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:
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