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?

Consider these sobering facts:

* 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.

Why Genetically Engineered Crops Threaten Your Health

If you listen to political talk-radio, you may have been puzzled by recent ads about seeds. Why would anyone be concerned about access to seeds? Because approximately 82 percent of the global seed supply is patented and owned by a handful of big corporations. Just six companies — DuPont, Monsanto, Bayer, Syngenta, BASF and Dow — control about 75 percent of the global agro-chemical market .

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.

Sen. Charles Grassley Asks Tough Questions of Leading Medical Schools

Ten of our nation’s top medical schools were given until Dec. 8, 2009, to respond to two tough questions posed by Sen. Charles Grassley of Iowa, the leading Republican on the Senate Finance Committee. Grassley expressed his concern that “any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling.” He was referring to the practice of drug companies and manufacturers of medical devices paying academic researchers for the use of their names on articles promoting the use of these firms’ products, articles written by someone else. In addition, Grassley fears the practice raises costs for taxpayers.

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!

JAMA Publishes Flawed Studies Linking Folic Acid and Vitamin B12 to Cancer

The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) have both voiced outrage over the publication of “Cancer Incidence and Mortality after Treatment with Folic Acid and Vitamin B12” in the 11/19/09 issue of JAMA. The leading researcher on this study, Dr. Marta Ebbing of Norway, is quoted as saying, “Folic acid fortification and supplementation may not necessarily be as safe as previously assumed.

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

United we are stronger’—ANH announces merger

ANH Press Release: ‘United we are stronger’—ANH announces merger

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.

ENDS.

For further information, please contact Meleni Aldridge, Executive Coordinator, ANH-International; ph: +44 (0)1306 646 600, email: mel@anhcampaign.org or Gretchen DuBeau, Executive Director, ANH-USA; ph: +1 202 467 1988, email: gretchen@anh-usa.org.

About the Alliance for Natural Health International?

www.anhinternational.org

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

ANH-Europe: www.anh-europe.org

ANH-USA:
www.anh-usa.org

Tuesday, December 01, 2009

Health Savings Accounts (HSAs) in the Crosshairs of Congressional Healthcare Reform

The editorial page of the Wall Street Journal has sounded the alarm about a bill proposed by Sen. Harry Reid, D-Nev., a bill that could cripple consumer-driven healthcare saving accounts plans. According to the editorial, not only does the Reid bill change the tax provisions to make HSAs less desirable, but its regulations threaten the very existence of the savings accaounts that have given consumers a more active role in managing their own spending on health.

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!

$500 million to be Spent Lobbying Congress on Healthcare Reform

In 2009, drug companies, medical device firms, insurance companies and other players in the medical industry will spend a record $500 million to influence the congressional vote on healthcare reform.


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.

Electronic Medical Records Don’t Reduce Healthcare Costs

President Obama insists that electronic medical records will help cut healthcare costs, and as part of the February 2009 economic stimulus bill, Congress has offered $19 billion in incentives to adopt them. But Sue Blevins of the Institute for Health Freedom has continually warned that EMRs could endanger privacy and 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?

Integrative Healthcare Included in Senate Healthcare Bill's Language

The American Association for Health Freedom (soon to be The Alliance for Natural Health-USA thanks to our merger with The Alliance for Natural Health) has worked for months to gain recognition for integrated healthcare in President Obama’s Comparative Effectiveness Research (CER) plan (part of the stimulus bill) and in multiple iterations of healthcare reform legislation. We have been assisted by many friends on the Hill ranging from Senator Harkin, a Democrat, to Congressmen Ron Paul, a Republican. We are now very grateful to Senators Mikulski and Conrad, who at our urging worked with other senators to modify the current senate healthcare bill to include representation for the integrative medicine community.

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

Raging Health Care Debate : Help for Consumers Caught in the Crossfire

Consumers caught in the quagmire of issues in the health care debate can find help from a member-based non-profit organization dedicated to protecting Americans’ rights to choose their practitioner and the practitioner’s right to practice integrative and natural medicine. Washington, DC-In a headline that read ‘Lobbyists Spend Millions to Influence Health Care,’ a Washington Post article reported that the Pharmaceutical Research and Manufacturers of America (PhRMA) spent $6.2 million in lobbying with the American Medical Association spending another $4 million in lobbying efforts to influence the outcome of the current health care plan. That does not include the millions and millions spent by health companies and associations as the article expands upon. That leaves many consumers wondering - who is lobbying for the average consumer? Knowledgeable consumers turn to the Alliance for Natural Health US (ANH-US), formerly known as the American Association for Health Freedom (AAHF) for helpful and forthright information on health care issues including how the new government plan may impact consumers in different areas.


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.


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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

Update on Last Week's House Healthcare Bill Story

Last week we discussed the difficulty of knowing what is and is not in the nearly 2,000 page House Healthcare bill. Here is a really bizarre example. Some commentators noted that the House bill provided for jail time of up to five years for anyone who failed to buy mandated insurance and also did not pay the financial penalty. Reference was also made to sections 7201 and 7203. Some bloggers immediately responded that this was pure fiction-- nothing about jail terms was in the bill and there were no bill sections 7201 and 7203.

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.

Conventional doctors claim integrative therapies lack research, study.

The Associated Press recently betrayed its bias in a series denouncing CAM/integrative medicine. Many who value integrated medicine were outraged by the following comment, which preceded each of four articles about complementary and alternative medicine published by AP: “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 Associated Press series on their use and potential risks”. Likewise, Dr. Jerome Kassirer — distinguished professor at Tufts University School of Medicine, former editor-in-chief of the New England Journal of Medicine and author of On the Take — has written: “People using alternative medicines are wasting their money and are being fooled into thinking they are getting something that is beneficial for them”.

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 to bring you advice from one of America’s largest doctor groups!

Incredible as it sounds, the American Academy of Family Physicians (AAFP) has announced a six-figure alliance with the Coca-Cola Co. to fund educational materials about soft drinks, to be posted on the academy’s consumer-health and wellness website. Although the AAFP’s CEO, Dr. Douglas Henley, insists the deal will not influence the group’s public-health message, nutrition educator Walter Willett, M.D., M.P.H., begs to differ, writing: “Coca-Cola like other sodas, causes enormous suffering and premature death by increasing the risks of obesity, diabetes, heart attacks, gout, and cavities”.

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 causes 100K cancers annually in the United States.

Two recent, jaw-dropping epidemiology reports barely made a ripple in the sea of healthcare information. According to the American Institute for Cancer Research, every year obesity causes more than 100,000 cases of cancer in the United States; and the Gallup-Healthways Well-being Index reported that more than 11 percent of Americans are diabetic and, given that trend, at least 15 percent or Americans will be living with diabetes by the end of 2015.

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.

Comment period for NCCAM’s five-year focus ends Nov. 19

Until that date, the National Center for Complementary and Alternative Medicine seeks input on its strategic plan. A column by journalist John Weeks in Integrative Practitioner, “Why we should seek to influence NCCAM’s next 5-year strategic plan” should spur you to voice your opinion.

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”.

Victory in The Senate

During the past few weeks, we met with most HELP Committee Senate offices to discuss our concerns and request an amendment to the Codex language in the Food Safety bill. Why were we so concerned? Because the original legislative language appeared to commit the US to the concept of harmonization of our food and supplement safety laws with a global standard. This global standard in turn is very likely to reflect European standards which are extremely hostile to dietary supplements.

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

Privacy, Science at Risk

In 2006, then President George W. Bush signed into law the dietary supplement and OTC bill dealing with reporting on adverse events. Now, the French food safety agency, AFSSA (Agence française de sécurité sanitaire des aliments), has launched a program to monitor the consumption of dietary supplements and any adverse events associated with their use.

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!

FDA’s Lax Ways

Despite increasing calls for transparency at the FDA, the agency’s sloppy performance continues to put consumers at risk both medically and financially.

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.

Your Body—Your Right to Choose!

The Massachusetts Public Health Emergency Preparation and Response Act (H4275) passed the House on 10.08.09. This piece of legislation articulates the authority granted to the Commissioner of the Department of Public Health during a ‘declared emergency’ and is companion legislation to S2028, which passed in April of this year. The two bills will now go through a reconciliation process in an appointed Conference Committee. Both bills have been in the spotlight due to recent H1N1 scares and hysteria, and the loss of rights during a pandemic.

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. Highlights are as follows:
    • 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 House has Passed Its Healthcare Legislation by the Narrowest of Margins.

What is and what isn’t in a bill that is nearly 2000 pages and weighs nearly 20 pounds?

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.