Important Update about Reforming the FDA

The FDA is a broken agency that censors medical science, obstructs innovation, and protects the medical monopolies that pay for much of its budget. The FDA needs reform, and we need your help to do it. Elected officials and government agencies know that numbers matter. When the public is aroused and demands action, Congressional action usually follows.

Even while the FDA is approving faulty and dangerous drugs and medical devices by the thousands, it continues what can only be described as a harassment campaign against those who want to rely on wholesome foods, dietary supplements, and lifestyle changes to achieve natural good health.

Here are just a few recent examples:

□ FDA employees recently protested in a letter to Congress that they have been forced to approve medical devices against their better judgment. The letter stated that FDA managers “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” The devices that FDA regulates impact more than 500 million adult and pediatric procedures performed every year in the U.S.

□ The FDA’s current efforts to reinterpret and thus amend the Federal Food, Drug, and Cosmetic Act threaten continued access to dietary supplements. If the FDA got its way, a food constituent studied for medical use (and published) could thereafter not be used as a new supplement. To illustrate how this might work, one company's fish oil is now an approved drug, and by this definition any new supplement with fish oil added might be prohibited. AAHF provided formal comments in response to the FDA’s deliberation process and explained why current law prohibits the FDA from adopting these anti-supplement regulations.

The FDA approves toxic chemicals for use in baby formula, baby bottles, and prescription drugs.

□ The FDA stated that no amount of melamine was safe in infant formula. Then melamine was found in formula at levels below 1 ppm. Suddenly the agency reversed itself and stated that melamine was safe provided that (coincidentally) there was no more than 1ppm. Was there a new study or other science to justify this claim? No. It appears to have been made up out of thin air in order to protect commercial interests. Melamine is a toxic chemical that has been linked to kidney damage and children are especially vulnerable.

□ The FDA recently declared Bisphenol – a (BPA) exposure to be safe for infants, even though Canada has banned the chemical from baby bottles. Thirty-six scientific advisers on an independent government panel concluded that the draft decision of the FDA on BPA used “unacceptable criteria for selecting data and depend(ed) heavily upon a key paper that is fatally flawed.” These experts concluded that the FDA chose industry-funded research studies and appeared to ignore hundreds of studies that have been funded by NIH (National Institute for Health) and its counterpart in other countries. BPA is linked to cardiovascular disease, type 2 diabetes, and liver enzyme abnormalities. In addition to being used in baby bottles, it is also used in water bottles, canned goods, dental fillings, children’s teeth sealants, and orthodontic sealants.

□ The FDA has approved the use of phthalates in prescription drugs and over-the-counter medications despite the fact that Congress banned phthalates in toys and other children’s products. Widely used as plasticizers, phthalates have been linked to abnormal reproductive organs, sperm damage, and reduced testosterone in animal tests as well as some human studies.

The epidemics currently plaguing this country-- cancer, obesity, diabetes, asthma and allergies, and many other debilitating disorders-- are linked to manmade products and processes that the FDA has approved and promoted. These failures have resulted in the sickest generation in the history of this country. The agency seems to have lost sight of its mandate to protect the public and has instead come to see itself as the guardian of corporate interests. It is time to end the many conflicts of interest linking the FDA to the pharmaceutical and chemical industries, conflicts of interest that betray the public and harm so many American consumers. It is time to reform the FDA!

Spread the word. Together, we can make a difference. We can turn the FDA around and help restore our national health. Please sign AAHF’s petition to reform the FDA at www.reformFDA.org.

FDA's Latest Threat to Dietary Supplements Defies DSHEA

For Immediate Release:

U.S. Contact: Gretchen DuBeau,
ph 800-230-2762
International Contact: Dr Robert Verkerk,
ph +44-1306-646-600

November 25, 2008

FDA’S LATEST THREAT TO DIETARY SUPPLEMENTS DEFIES THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT ACCORDING TO TWO LEADING HEALTH FREEDOM GROUPS

Today, the American Association for Health Freedom (AAHF) and its international affiliate, the Alliance for Natural Health (ANH), jointly submitted comments to the US Food and Drug Administration (FDA) in response to its request for comments from industry and consumers to help them interpret recent changes to Section 912 of the Amendments Act of 2007 (FDAAA). The submission was accompanied by comments from 700 concerned citizens and practitioners exasperated over the latest threat to supplements from the FDA. The FDA’s unprecedented, controversial, and ambiguous changes to Section 912, specifically the addition of Section 301 (ll), may mean that all food products, including dietary supplements, could be barred from being marketed if they have been the subject of published clinical studies. AAHF and ANH point out that this provision is so far-reaching that a very large number of commonly consumed foods could be impacted by the new regulation and hence barred from interstate trade.

“If the FDA determines that Section 301 applies to dietary supplements, this would strangle innovation. It would create a ‘Catch 22’ situation in which supplement producers who undertake scientific research on new supplements will find that their very research will lead to a ban on the proposed supplement. This is totally senseless. This is too senseless even for the FDA,” said Gretchen DuBeau, AAHF Executive Director.

At the crux of the issue is whether the new Section 301 applies to dietary supplements, which are already covered by Section 201 (ff) of the Federal Food, Drug, and Cosmetic Act (FDCA). This means that Section 301 is in direct conflict with Section 201 of the FDCA that already governs dietary supplements through the Dietary Supplements Health and Education Act (DSHEA). DuBeau added:

“This conflict—which is supported by influential case law— gives Section 301 of the FDAAA no legal basis. Congressional language has already made clear and unambiguous that the FDAAA, currently under consideration, shall not affect the regulation of supplements under DSHEA.”

Section 201 currently also prevents the marketing of dietary supplements which have been subject to published clinical studies—but only when they have also been the subject of a Investigational New Drug (IND) application.

Dr Robert Verkerk, executive and scientific director of the ANH emphasized:

“Unlike Section 201 of the FDCA, the proposed new Section 301 of the FDA Amendments Act doesn’t just limit the ban to supplements that have been subject to drug applications, it applies a ban to some of the best researched and most useful supplements and ingredients on the market today. This is clearly nonsensical and if enforced, would represent one of the most severe restrictions seen in any country at any time.”

“There will be no shortage of big corporations that will exploit this situation to their benefit unless the scope of Section 301 is both clarified and narrowed”, commented Gretchen DuBeau, “one such company is already trying to use it to ban the natural zero-caloric sweetener stevia, given that stevia has been subject to scientific research and has been a thorn in the side of the sugar and artificial sweetener giants for years.”

Since the FDA’s call for comments issued on July 28, 2008, the AAHF sent an alert to its members, including professional, integrative medicine organizations, apprising them of the threat posed by the FDAAA’s Section 912. More than 700 concerned doctors and citizens emailed comments to AAHF, which accompanied the AAHF’s joint submission with ANH. Among the prestigious groups opposing the FDA’s erroneous interpretation are the International College of Integrative Medicine (ICIM), the American College for Advancement in Medicine (ACAM), The American Holistic Medical Association (AHMA), the Certification Board for Nutrition Specialists (CBNS), and the American College of Nutrition (ACN).

ENDS.

FAULTY STUDY TARGETS VITAMINS C AND E

U.S. Contact:
Gretchen DuBeau,
ph 800-230-2762

International Contact:
Dr Robert Verkerk,
ph +44-1306-646-600

November 18, 2008

FAULTY STUDY TARGETS VITAMINS C AND E
Finding of No Cardiovascular Protection Was Predictable

Today, the American Association for Health Freedom (AAHF) and its international affiliate, the Alliance for Natural Health (ANH), have together sharply criticized defective and misleading research published earlier this month in the Journal of the American Medical Association (JAMA). The research triggered headlines around the world suggesting that neither vitamin E nor vitamin C supplements protect against cardiovascular disease in older men.

The study by Howard Sesso and colleagues from Harvard, entitled the “Physicians’ Health Study II”, included over 14,600 male physicians over a ten year period, used the least potent form of vitamin E and incorrect dosages of both vitamins C and E , according to an analysis conducted by ANH experts, Dr Steve Hickey, Dr. Damien Downing, and Dr. Robert Verkerk.

The ANH analysis, “Designed to Fail: A Trial Without Meaning”, criticized the Sesso et al. study for using synthetic dl-alpha-tocopherol, which is less effective than the natural and more complete forms of vitamin E and is thus more likely to not reveal any benefit. Additionally, the vitamin E dose in the study (400 IU every other day) is far below the dose taken by many who supplement making the findings irrelevant to older supplement consumers who are aware of extensive research and clinical evidence on higher dose vitamin therapy.

The JAMA paper included a 500 mg daily dosage of vitamin C, which is only half of a typical one-gram tablet of the type popular with supplement users. Evidence suggests that dynamic flow levels of vitamin C, which may prevent heart disease, begin at daily intakes above about 3g per day, best delivered in divided doses.

Additional complaints about the JAMA study include the use of an unidentified placebo, which may have included beneficial nutrients such as magnesium, failure to control diet for synergistic nutrient interactions that may have skewed test results, and the relevance, or otherwise, of applying these findings among physicians (the study group) to all men across the population.

“Considering that the methodologies were significantly biased against finding a positive result from vitamins C and E as determined from both available research and clinical evidence, one has to ask who stands to benefit from these findings? How, for example, would the pharmaceutical industry be impacted from diminished sales of their vitamins if people, under the belief that vitamins provided no benefit in the treatment and prevention of cardiovascular disease, instead chose pricey prescription drugs,” asked Gretchen DuBeau, AAHF Executive Director.

Dr Damien Downing, ANH Medical Director, President of the British Society of Ecological Medicine and Editor-in-Chief of the peer reviewed journal, the Journal of Nutritional and Environmental Medicine, on reading the Sesso et al. paper independently responded, saying it was “an intervention designed to fail”!

ANH Scientific & Executive Director, Dr Robert Verkerk added, “With three of the world’s largest drug companies, namely BASF, Wyeth and DSM—formerly Roche—supplying the low dose synthetic vitamins for the study, it’s perhaps not surprising that the outcome is made to look bad for vitamins. A trial like this costs a huge amount of money and is a waste of much needed research funds. Why don’t they ask the people who work with nutrients on a daily basis—integrative medicine doctors—what nutrient forms, combinations and dosages are most likely to work?”

The ANH analysis, “Designed to Fail: A Trial Without Meaning”, is available at: http://www.anhcampaign.org/files/081117_Sesso_PHSII_ANHrebuttal.pdf.


ENDS.


NOTES TO THE EDITOR

About the American Association for Health Freedom (AAHF)
http://www.healthfreedom.net/

The American Association for Health Freedom (AAHF) is a 501©4 nonprofit organization serving as the politically active voice at federal and state levels to protect Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislature and crafting legislation; acting as a government watchdog and filing comments on proposed rulings; educating the public, press, and decision-makers on integrative medicine; initiating legal activities and joining and forming significant coalitions.

About the Alliance for Natural Health (ANH)
http://www.anhcampaign.org/
The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to protect and promote natural healthcare, using the principles of good science and good law.
The ANH’s overriding goal is to help develop appropriate legal and scientific frameworks for the development of sustainable approaches to healthcare. As in the fields of energy and agriculture, sustainable healthcare invariably requires use of natural products which are inherently compatible with human biochemistry and physiology. Within this setting, consumers and health professionals should be able to make informed choices about a wide range of health options, and in particular those that relate to diet, lifestyle, traditional medicinal and non-drug-based or natural therapies, so that they may experience their benefits to the full while avoiding unnecessary risks.

Access To Healthcare Counseling In Jeopardy

New Jersey Legislators Consider Restrictive Legislation to Limit Nutritional Advice

Contact: Gretchen DuBeau, 800-230-2762
For Immediate Release: September 24, 2008

Today, the American Association for Health Freedom (AAFH) urged New Jersey legislators to vote against Assembly Bill A2933/Senate Bill S1941, the Dietician/Nutrition Licensing Act currently under consideration by New Jersey State Senators and Members of the Assembly.

The companion bills would prevent any practitioner other than a dietitian registered by the American Dietetics Association from teaching, consulting, or advising about health, nutrition, supplements, diet, food, or food materials.
The vote, scheduled for early October in both the Senate and the General Assembly, would give unprecedented authority to registered dieticians. Traditional experts on healthcare, including Ph.D. nutritionists from Rutgers University's prestigious Department of Nutritional Sciences, would be barred from offering nutritional advice in New Jersey.

“Nutritionists and doctors holding the American College of Nutrition's CBNS certificate have a Master's degree at a minimum, usually a Ph.D., yet are excluded by this bill. In comparison, most dieticians registered by the American Dietetics Association, the sponsor of this bill, do not hold advanced degrees. Their training is mostly in food management and only partly in nutrition. This makes no sense,” said American Association for Health Freedom’s Executive Director, Gretchen DuBeau.

AAHF highlighted research from Harvard's Department of Nutrition published in the October 2001 issue of the New England Journal of Medicine which documented that 90% of all type II diabetes can be eliminated by avoiding bad fats and eating good fats, eating lots of fruits and vegetables and modest amounts of whole grains, supplementing wisely, and exercising daily.

“It is vital with a record 78% of our nation’s healthcare dollars going to the treatment of chronic disease that other qualified practitioners be allowed to offer nutritional counseling. Chronic conditions are directly related to lifestyle choices, and nutritional counseling is a critical part of patient care by any practitioner,” added DuBeau.

If you would like more information, please contact
Gretchen DuBeau at 1-800-230-2762.

Drug Lobbying Still Number One

American Association for Health Freedom (AAHF) is lobbying on your behalf EVERY DAY right here in our nation’s capitol. And because your voice is so crucial to our efforts, we are constantly looking for ways for decision makers to hear your concerns.

A new report from Center for Public Integrity (CPI) shows what we’re up against on Capitol Hill. In 2007, industries and special interests spent $17 million for every day Congress was in session (the drug industry spent the most of all).

The CPI analysis of federal lobbying data details that pharmaceutical industry spent $168 million in their lobbying efforts in 2007.

The spending represents a 32 percent jump over 2006. Driven in part by a busy legislative calendar dominated by issues critical to the industry, the effort raised the amount spent by drug interests on federal lobbying in the past decade to more than $1 billion.

The trade association for pharmaceutical manufacturers (Pharmaceutical Research and Manufacturers of America) was the largest spender at $22.7 million. Biomedical firm Amgen ($16.2 million) and pharmaceutical company Pfizer ($13.8 million) rounded out the top 3. Other big spenders last year included Roche Holding AG ($9 million), Sanofi-Aventis ($8.4 million), GlaxoSmithKline ($8.2 million), Johnson & Johnson Inc. ($7.7 million) and the trade group Biotechnology Industry Organization ($7.2 million).

In 1992, the pharmaceutical industry employed 675 lobbyists, now there are currently 1,274 registered lobbyists in Washington D.C. lobbying for Big Pharma.

Too often, the health freedom community finds itself up against Big Pharma and though we’re out spent in lobbying, advertising, and in other resources; we’re not outnumbered! Your involvement is crucial to us truly achieving health freedom. Each time you take action on an alert, share our news and alerts with friends and family, or financially support AAHF, you are promoting health freedom.

Click here for the full CPI article.

Abuse of FDA Citizen Petitions

Did you know that:

A drug company petitioned the FDA to ban a B vitamin in order to protect its own drug product?
Or that the second largest drug company in the world is using the FDA’s citizen petition process in order to try to prevent any dietary supplement product from making weight loss claims. The company wants weight loss claims to be re-classified as disease claims!

If you’ve been reading our efforts to stop Wyeth from working with the FDA to ban bio-identical estriol, then you’re probably not surprised that the FDA is being used to try to ban natural products.

But did you also know that you can help keep natural, safe products on the market by simply writing Congress and the FDA and telling them you’re supportive of Vitamin B6 and that you don’t want the FDA restricting free speech?Act now!

It is important that as many messages as possible be sent to the FDA opposing these petitions. Since the FDA has made it more difficult for citizens to contact them, we will be personally hand-delivering the messages. It is also important that members of Congress hear from their constituents on this important issue as well. In order to send the message to the FDA and your congressional representatives, click here. Don’t forget to personalize your letter.

THE DETAILS

Medicure Pharma’s attempt to ban the natural, bioactive form of vitamin B6

On November 30, 2007, Medicure Pharma submitted a citizen’s petition to the FDA asserting that that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) should be banned. Despite the fact that P5P most important, bioactive, natural form of vitamin B6, Medicure wants to see the product banned from sale by the US dietary supplement industry because its marketing of P5P-containing supplements undermines the company’s incentive to continue developing its drug product (MC-1).

Dr. Robert Verkerk, Executive Director of our affiliate, the Alliance for Natural Health says, “This is an astonishing development that shows just how easily pharma companies are willing to show their hand. Well I’m sorry, natural got there first! You can’t just decide to have a natural form of a product banned because it interferes with your drug patents. We’ve found two patents secured by Medicure for P5P to be used in cases of heart disease. It seems they’ve come to the same realization as millions around the world—vitamins and other natural products can be used to help protect you from chronic diseases, including heart disease.”

A recent, large scale Japanese study, for instance, published in the Journal of the American College of Nutrition (2008 Feb;27(1): 127-36), concluded "Dietary intake of vitamin B6 was associated with a reduced risk of coronary heart disease among middle-aged non-multivitamin supplement users. Dietary folate and vitamin B12 were also suggested to be protective factors for coronary heart disease."Glaxosmithkline’s attempt to shut down competition from the natural products industry in the weight loss field

On April 17, 2008, the world’s second largest drug company, GSK, along with the American Dietetic Association and the Obesity Society—both regarded by many as fronts for some drug companies — petitioned the FDA to try to prevent any dietary supplement product from making weight loss claims. The company wants weight loss claims to be re-classified as disease claims, therefore making them the sole domain of treatments with licensed pharmaceuticals. GSK’s Alli product directly competes with the wide range of dietary supplements that help support weight loss—and Alli has become the third top-selling obesity drug less than a year after its launch, despite serious side effects.

Commenting on the GSK petition, Verkerk added, “Obesity control is a growth area for Big Food which contributes so greatly to the problem. GSK —which works in cahoots with Big Food—now wants a slice of the action and it wants to eliminate the main source of competition—the natural products industry. Consumers must engage with these petitions and have their say. The time for sitting on the sidelines is over.”These Latest FDA Petitions Follow the Recent Ban on Bio-Identical Estriol

Wyeth pharmaceuticals petitioned the FDA to ban bio-identical estriol, even though bio-identical estriol is a critical ingredient in bio-identical hormone therapies, and no adverse event had ever been associated with its use. AAHF, along with our congressional allies, are currently attempting to reverse this ban. (Read more about this attack and our efforts.) Please do not let these new petitions to the FDA succeed.

Take action today!

Estriol Resolution Update

It’s not too late to help us make a difference. In the past few weeks we have hit Congress hard. Thousands of our members have written their House representative in support of a resolution that calls upon the FDA to stop their new policy of restricting women’s access to prescriptions containing estriol. The American Association for Health Freedom (AAHF) ran a full-page ad in Roll Call supporting H. Con. Res. 342 and highlighting the hypocrisy of Wyeth. The same day, hundreds of compounding pharmacists were on the Hill meeting with members of Congress. We also hand delivered letters of support for the resolution from various medical and consumers groups, representing millions of consumers and practitioners.

We’re pleased to announce that the Senate has now introduced Senate Concurrent Resolution 88 – a companion resolution to H. Con. Res. 342. Slightly different than the House resolution, the Senate resolution adds the language “unless the FDA holds a public comment period on the issue and can document evidence of adverse events and other safety issues to justify such policy.” Additionally there are now about 30 cosponsors of the House resolution, many which were added last week in response to the efforts above.

We ran the ad “ Shame on you, Wyeth” on June 3 in Roll Call, the most widely read daily paper on Capitol Hill and hand delivered letters to all 435 House of Representative’s offices on that same day. We ran another Roll Call ad, “ Shame on you, Wyeth, Part Two” on June 17 in support of the just introduced Senate companion resolution and then hand delivered letters to each of the 100 Senate offices. (Read more about our efforts.)

Help us build on this momentum and TAKE ACTION by contacting your representatives today.

Don’t forget to tell your friends and ask them to write to Congress!

Clicking raises money for health freedom!

Thanks to the Health Freedom Foundation’s 2-year partnership with Goodsearch.com, raising money to help support our efforts is literally a mouse click away. Log onto www.goodsearch.com -- a search engine powered by Yahoo! --and type "Health Freedom Foundation” into the "I support" box. The Foundation will then receive a donation each time you search the Web using GoodSearch.

What's great is that you use GoodSearch just as you would any search engine. Again, it's powered by Yahoo!, so you get proven, high-quality results.

If you allow cookies, after the first time, each time you return to the home page, Health Freedom Foundation will appear as your designated charity. There is even a button you can click to see the number of searches and the amount raised.

Add GoodSearch to your bookmarks or make it your homepage to make it easier to use. Also, spread the word to your family and friends to help generate more contributions. GoodSearch estimates each search will raise $0.01 for your designated charity. 100 supporters searching twice a day could generate $730 a year, 1000 supporters - $7,300, and 10,000 supporters searching twice a day could generate $73,000!

With your help, GoodSearch can generate donations, at no cost to you that will help with pressing health freedom issues.

Last year, search engines generated close to $6 billion in revenue from advertisers. With GoodSearch part of this advertising revenue will now be directed to The Health Freedom Foundation.

We hope that not only will you use GoodSearch as your main search engine from here on out, but will also pass this message on to your friends and family. The more people who use this, the more money will go to The Health Freedom Foundation.

We appreciate you checking out GoodSearch and using it as your Internet search tool. Remember, every search you make will raise money for health freedom.

Best,

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom4620 Lee Highway, Suite 210Arlington, VA 222071.800.230.2762Fax: 703.294.6380http://www.healthfreedom.net/

Integrative Medicine Practitioners Are Targeted More Often Than Their Colleagues

Advocacy group publishes A Practitioner's Guide to Protecting Your License and Your Practice from Medical Board and Government Action.

(PRWEB) April 25, 2008 -- According to the American Association for Health Freedom (AAHF), integrative medicine practitioners' licenses are typically more vulnerable than their colleagues for two main reasons: their modality of practice and procedures methods are often viewed as not being science based, and they often are solo practitioners that have fewer resources to counteract aggressive state medical boards and their investigators.

Through phone calls and requests for help that AAHF receives each year, they believe that a majority of investigations of integrative medicine practitioners occur not because of patient harm or patient complaint but because a disgruntled employee, competitor, insurance company, or someone who doesn't believe in integrative medicine complained to the state medical board.

"We receive numerous requests for help each year because state medical boards are over-zealously pursuing integrative medical doctors," Brenna Hill, the AAHF Executive Director said. "Unfortunately by the time they call us they've already signed their rights away. At that point there's not much we can do to help." Often these charges may make the practitioner a felon.

Inspired by their numerous members who have gone through exhausting state medical board investigations and legal battles to retain their licenses, AAHF has published A Practitioner's Guide to Protecting Your License and Your Practice from Medical Board and Government Action. The well-respected law firm, Augustine, Kern and Levens, Ltd, wrote the Practitioner's Guide. AAHF hopes that this guide will help practitioners think ahead and create a plan.

"It is always a good policy to plan ahead," Hill said, "The decisions you make at the beginning of a state medical board investigation could mean the difference between saving or losing your license and your freedom to practice the type of medicine you believe is most beneficial to your patients."

Although the Practitioner's Guide does not provide legal advice and is not tailored to any specific situation, it will provide physicians with general guidelines and information in dealing with medical boards. The guide includes best practices to help a practitioner institute an office policy and plan if there's a knock on the door and how to respond to investigators as well as what to do if presented with a subpoena and how to handle a settlement offer. AAHF is providing the guide free to their Professional members.

AAHF is a non-profit association based in the Washington DC area that promotes health freedom legislation in all 50 states and in Congress. As the politically active voice at the federal and state level for integrative medicine, AAHF is involved in crafting, monitoring, and supporting legislation that allows the right of the consumer to choose and the practitioner to practice. For more information, please visit www.healthfreedom.net.

Latest Attack on Dietary Supplements

By now, you have probably read the headlines such as “Vitamins May Shorten Users' Lives,” “Vitamins may increase risk of death," or “Vitamins A, C and E are 'a waste of time and may even shorten your life.”

These biased articles are based on the latest Cochrane review which more or less copies the JAMA paper from February 2007.

Unfortunately, bad science and misleading media stories are confusing consumers. As dietary supplements become more popular and threaten the bottom line of traditional medicine and Big Pharma, we see more and more studies and articles that try to convince the public that dietary supplements are useless, unregulated, or even deadly.

Often these studies are superficial and if you scratch the surface you can see the bad science and inaccurate reporting. AAHF’s international affiliate, Alliance for Natural Health details some of the reasons why this latest round of headlines are based on bad science.

The article highlights are below describing why it's bad science:

1. This isn’t new.

2. This isn’t research.

3. This isn’t meaningful.

4. This applies only to synthetic forms of vitamins (as produced by the pharmaceutical industry).

5. Natural vitamins and minerals are lifesavers.

6. Over the top on synthetics!

7. Two bites at the cherry.

To read the full article, click here. Don’t forget to join the American Association for Health Freedom to support our lobbying efforts at the federal and state level or make a tax-deductible donation to the Health Freedom Foundation to help support education and international efforts.

FDA Doesn't Want Your Voice Heard

We’ve heard from several sources that the FDA is whispering into Congressional ears to ignore letters from their constituents about bio-identical hormones. The FDA is spreading the rumor that the health freedom community is “unfairly” upset about their recent ban on estriol and bio-identical hormones. Furthermore, the FDA continues to insist that they are not “restricting” estriol and that physicians wishing to treat their patients with drugs containing estriol may submit an investigational new drug application.

On January 9, 2008, the FDA essentially BANNED estriol (which is used in 80% of bio-identical hormones). They stated that estriol is an unapproved drug and unless they have a valid investigational new drug application, pharmacy operators may not compound drugs containing estriol. The same day at a press conference, the FDA admitted that they knew of no serious adverse events reported in conjuncture with estriol (even though doctors and hospitals are required to report ALL adverse events.

On Thursday (April 3), we’re meeting with members of Congress to discuss this issue and others related to health freedom. We’ll be sure to tell you how the meetings went!

If you’re a practitioner, a patient, or someone who wants the FDA to stop practicing medicine, please continue to read.

WHAT YOU CAN DO:

Read the timeline and Draw Your Own Conclusion – is the FDA doing Wyeth’s bidding?

Contact Congress and the President of the US and let them know that you want the FDA to stop attacking bio-identical hormones.

Personalize your letter. Tell your story, edit to reflect your points of interest (this is VERY important, please take the extra time!)

Spread the word! We need the loudest voice possible – let your friends and family know of this threat, send an email. Tell people to visit www.healthfreedom.net. Download, print, and distribute our flyer ( click here) and if you don’t have a printer, let us know how many you need.

Join AAHF so we can continue to make a difference on this and other important issues.

Make a tax-deductible donation to the Health Freedom Foundation so we can continue educational efforts and pursue opportunities to block the FDA’s assault on bio-identical hormones.

Brenna Hill
Executive Director
American Association for Health Freedom/Health Freedom Foundation
4620 Lee Highway, Suite 210
Arlington, VA 22207
1.800.230.2762
www.healthfreedom.net

AER Bill Introduced in the House

On Monday, HR 6168, was introduced in the House. The lead sponsor is Chris Cannon, (R-UT), along with 8 other Republicans and 2 Democrats. The bill has been referred to the Energy and Commerce Committee, with little chance for consideration this year. Legislatively, this prevents a Senate passed bill from being held at the desk in the House, at the request of Pelosi, et al.

AER Bill Update

Tuesday morning - we've just heard that the AER bill is ready to be dropped on the floor. Please contact your representatives ASAP and help spread the word.

The latest about the AER Bill

S.3546 the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER bill) is the latest bill impacting dietary supplements.

If S. 3546 becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.

We have just heard that the AER bill has been added to the Senate calendar, and staff expect it to be considered this week. What is unknown is whether it will be a roll call vote (recorded) or under unanimous consent*. Recorded is preferable and is expected.

*unanimous consent - A Senator may request unanimous consent on the floor to set aside a specified rule of procedure so as to expedite proceedings. If no Senator objects, the Senate permits the action, but if any one Senator objects, the request is rejected. Unanimous consent requests with only immediate effects are routinely granted, but ones affecting the floor schedule, the conditions of considering a bill or other business, or the rights of other Senators, are normally not offered, or a floor leader will object to it, until all Senators concerned have had an opportunity to inform the leaders that they find it acceptable.

There is still time to halt this bill if we make our voice heard today and encourage others to contact Congress as well. Contact Congress through our online action center.

We are reading the bill report now and will post more shortly. At first glance it appears that importation will be affected, private labeling will most likely disappear, and third-party vendors will be created to handle the AER process for the manufacturers.

von Eschenbach Confirmation On Hold

Due to the negative response from thousands of people, and the backfiring on the FDA's tentative Plan B over-the-counter emergency oral contraceptive proposal, the Senate HELP Committee has delayed a vote on the nomination of Andrew von Eschenbach, MD to be the next FDA Commissioner.

HELP committee Chairman Sen. Mike Enzi (R-WY) is planning to seek a vote in committee in September, when Congress returns from its August recess period. Two HELP Committee members have said that they will put a "hold" on a full Senate vote, even if approved by the HELP committee, until the Plan B issue is resolved. This means that until these "holds" are released, even if voted out of the HELP committee, the full Senate cannot vote on the nomination.

Please continue to urge your Senators to ask important health freedom questions of von Eschenbach - just click here: http://ga4.org//campaign/FDA_questions.

Breaking News: Ruling for Cherrix family

Abraham Cherrix DOES NOT have to report to a Norfolk hospital for forced chemotherapy.

That's the ruling Tuesday afternoon by an Accomack County Circuit Court judge, after lawyers for 16-year-old Starchild Abraham Cherrix appealed a ruling by a juvenile court judge.

Virginia Attorney General Bob McDonnell filed a brief to the Circuit Court Tuesday supporting a stay, arguing that Abraham deserves the right to appeal the order to the Circuit Court before undergoing medical treatment.

Judge Glen Tyler said Abraham and his parents will get a new trial in Circuit Court as soon as possible. (NEW: Trial is set for August 16 & 17.)

The judge also returned full custody of Abraham to his parents. That ruling suspends an order by the juvenile court judge that required Abraham's parents to share custody with the Accomack County Department of Social Services.

This is a new territory for the American Association for Health Freedom (AAHF) and Health Freedom Foundation (HFF). We were contacted last week by Sharon Smith (the Cherrix family representative) and since then we have been hearing about other cases where the parents and authorities clashed over a minor’s treatment. This is not about choosing an "alternative" treatment but about what is the legal (and constitutional) rights of parents and the state system in regards to children's health. We are gathering information and will be developing a national solution to this critical and heartbreaking issue. We are assisting the family as best as we can with legislative, legal, and PR efforts. Please share your stories and ideas (send to healthfreedom2000@yahoo.com).

You might also be interested in reading a recent article by our Vice-President, Dr. Sherri Tenpenny, titled “WHO OWNS YOUR CHILD?”

Your financial support is greatly needed and here are two ways you can help.

1) If you would like to support the Health Freedom Foundation efforts in addressing this issue, please make a tax-deductible donation today, click here.

2) If you would like to support the family directly with a financial contribution, please send your check to:
Abraham Cherrix Fund
c/o RBC Centura Bank
2422 Princess Anne Rd.
Virginia Beach, VA 23456

If you have any questions about the Cherrix fund you can email: abrahamsfund@abrahamsjourney.com

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom
4620 Lee Highway, Suite 210
Arlington, VA 22207
1.800.230.2762
Fax: 703.294.6380
www.healthfreedom.net

Update on Abraham Cherrix

Abraham's lawyers filed a motion today at 10:30 a-m in Accomack County Juvenile and Domestic Relations Court to try to stop enforcement of a judge's order requiring Abraham Cherrix, 16-year-old Eastern Shore cancer patient to report to a hospital by Tuesday, July 25th and have his parents authorize treatment (i.e., chemo).

The family will be supporting Abraham in his decision to not accept chemo and understands that this could be a long and hard struggle.

If Abraham is forced to comply with the order, "there's no way to undo the chemotherapy and radiation" and essentially that would end their path to further appeals.

As of 5:15pm (EST), they have not heard from the courts. The lawyers will be on Court TV tonight and Abraham and his father Jay will be on Hannity & Colmes tonight.

State of VA forcing a 16-year to receive chemo

Whether you believe in integrative medicine or not, this is a terrible situation.

16-year old Abraham Cherrix has cancer - Hodgkin’s. He responded poorly to chemo last summer and in fact believed that it was killing him. By the time he got home after the treatments, he couldn’t walk – his father would have to carry him into the house.

So he started to do research and decided to try a treatment (organic foods and herbal supplements – Hoxsey) in Mexico. His father, Jay, a bit skeptical, traveled with the then 15-year to Tijuana. When they returned, the parents talked to their son’s oncologist and told her that the family wanted to try an alternative therapy because the chemo was not working but wanted her to stay on and monitor the progress. She was very dismissive of their choice and told them she wanted no part of it. As soon as they left, she called family services.

Not long after, the family received a summons to family court where they erroneously thought they just needed to explain their course of treatment. They walked in with no legal representation and ultimately lost partial custody of Abraham (who was also under court orders to not leave the state of Virginia).

With the help of Sharon Smith, a local woman who read about them, the family attained lawyers and started to receive national media attention. )

They parents self-employed (run a kayaking business on an island on the Eastern Shore of VA) and do not have financial resources to undertake this type of battle so they are relying on donations and pro bono work.

The judge (who is a visiting judge, who’s expertise is real estate) was supposed to email his final ruling on Tuesday, July 18. It did not come and there was no explanation as to why or when it would be delivered. Would you be surprised to learn that the judge gave his ruling on Friday, July 21st at 5:20pm? That is a common trick that is used when people DO NOT want the media to pick up an item. It is very hard to generate action and attention over the weekend.

The judge ruled that the parents were neglectful and that they needed to go to the hospital by Tuesday, July 25th and sign the papers authorizing that the doctors could provide the treatment that they – as medical professionals – deem necessary.

We cannot allow this to happen. There are legal, PR, and legislative/political maneuvering that must start immediately.

We are working with the family and our general counsel, Mike Ruggio has been in discussion with the Cherrix’s lawyers. Additionally we are contacting members of Congress and the family has been visiting local representatives.

We will shortly have a plan of action for you and will need your support. Your voice, your outrage, your ideas, and your financial support are all greatly needed.
We will be updating the blog over the next few days with ways you can help and with any late breaking news.

Here are some of the recent news articles:

USA Today
Abraham's website (temporarily down due to exceeded bandwidth)
CNN
MSNBC

We believe our bill Access to Medical Treatment Act (HR 2792/S.2618) while addressing the issue in a peripheral manner, would not help Abraham directly because Mexico is not named as one of the countries. Though it would help other children and adults so please take a moment to support the bill.

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom
4620 Lee Highway, Suite 210
Arlington, VA 22207
1.800.230.2762
Fax: 703.294.6380
www.healthfreedom.net
email: healthfreedomblog@yahoo.com

The Dietary Supplement AER Bill

American Association for Health Freedom would like to thank Senators Hatch and Harkin for their work on S.3546 the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the AER bill). We appreciate their long-time support and belief in the right of the consumer to access dietary supplements. Ultimately, after careful review of the bill, we DO NOT support S. 3546.

If S. 3546 becomes law, it will amend the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.

As the bill has already been voted on by the HELP Committee, we need you to take action today and encourage your contacts to do the same. We must move fast to make our voices heard. Click here to contact Congress.

As the politically active voice of the healthcare practitioner and their patients, AAHF sees S. 3546 as part of a bigger picture that would like to treat dietary supplements more like pharmaceuticals and not as food as it currently stands. We believe that as soon as you accept differential treatment between dietary supplements (as concentrated nutrient forms) and conventional foods, you have given up very valuable ground.

S. 3546 would also discourage consumers from properly submitting their adverse events. Consumers should be discussing their adverse event reactions (especially “serious adverse events” as per the bill) with their healthcare practitioner rather than just sending a complaint to the manufacturer or retailer. There is a serious potential for abuse of the system and supplements could easily be blamed in place of things as divergent as pharmaceutical drugs, recreational drugs, genetic sensitivities, food intolerances, alcohol abuse, etc. A healthcare professional is crucial to determining the adverse event and ensuring that needless blame is not pointed towards the wrong substance.

Additionally, the FDA is already broken and this bill would just add to its misery. The FDA's own enforcement reports (for drug products) show it to be an agency under increasing pressure to do more with less. The number of warning letters issued to pharmaceutical companies has dropped over the past 10 years even as product recalls have increased. In other words, the agency is allowing more manufacturer product mistakes to reach the market. Adding supplements would reduce enforcement efficiency even more - for both drugs and supplements. This bill is a classic demonstration of the federal government wasting money to protect the public from a relatively small health threat on the part of dietary supplements. In fact, food is actually more dangerous than dietary supplements and cause 5,000 deaths and over 80 million hospitalizations a year in the US, according to the Centers for Disease Control.

We do not wish to discourage the dietary supplement industry in reporting their adverse events and we believe that over-the-counter medications should have a mandatory adverse event reporting process but S.3546 is not what is best for the American dietary supplement consumer.

Because we’re all about the consumers right to choose and be informed, we wanted to let you know that if you decide that this a bill that you want to support, please visit Citizens for Health or National Nutritional Food Association for more information.

Brenna Hill
Executive Director
Health Freedom Foundation and American Association for Health Freedom
4620 Lee Highway, Suite 210
Arlington, VA 22207
1.800.230.2762
Fax: 703.294.6380
www.healthfreedom.net

A Bad Year for Washington Post Articles

I’m As Mad As Hell And I’m Not Going To Take It Anymore. Are You?

I opened the Washington Post this morning and discovered that once again it is slamming integrative medicine and dietary supplements. Another black eye from mainstream media. Well, enough is enough. It is time to put up our dukes and come out fighting! We need to come together as a community and educate (and shame) them into balanced and fair reporting. Isn’t it time to have our research and testimonies seen in such a major media source?

Repeatedly, the Washington Post has printed articles that are little more than press releases from pharmaceutical companies, the government, and big trade associations. Or even worse, Big Pharma-funded educational institutions with “new” studies showing the “dangers” or “ineffectiveness” of therapies and supplements that are commonly accepted in the “alternative” world as safe and effective.

Okay, so we don’t have the money to power the PR machine that the drug czars have. We do have the might on our side. Let’s use one of the best tools at our disposal. Our voice. Read below to find out how you can help make an impact.

Today’s issue of the Washington Post Health section includes the following:

A Bad Year for Favorites. When Put to the Test, Americans’ Most Trusted Supplements Failed. Highlights the following: Glucosamine & Chondroitin Sulfate; Calcium and Vitamin D; B Vitamins, Multivitamins, and Echinacea. The articles points to studies (but does not name them) to show the evidence that these supplements are ineffective. Below, we give you more information about the studies mentioned.

No Needles. Acupuncture No Better Than Placebo for Hot Flashes. Uses a study by Mayo Clinic and says that investigators were disappointed with results.

Fx for Salt. Cut it Out. The article starts off with a plug for American Medical Association and their weak resolution of “50 percent reduction in sodium content of processed foods, fast foods, and restaurant meals over the next 10 years.” I guess it’s better than nothing.

Natural Herbal. An article talking about how mostly ethnic communities don’t associate medicinal herbs with pills and instead use the leaves, roots, and roots, and fruit into teas and potions “claimed to have health benefits – though few are proved.” The article uses Consumers Reports’ Natural Medicines Comprehensive Database as source.

Please take a few moments to read for yourself the articles. Visit the Washington Post Health Section (you may have to sign up, it's free).

Then use our online action center to send your response to the Publisher, Editor, Health Section, and Reporter.

UPDATE: In less than 24 hours, over 1,500 letters have been sent. Please take a moment to write your own response!


STUDIES

Glucosamine/Chondroitin

Study: National Center for Complementary and Alternative Medicine (NCCAM)

A common flaw with this trial (as most clinical trials) is that they did not use the commercially available supplements.

The article almost throws away the mention that the supplements did reduce moderate-to-severe joint pain by 25%. Not mentioned are results from a 24-week clinical trial in Europe that found that glucosamine sulfate was more effective in relieving osteoarthritis pain than the pain medicine acetaminophen. The results of both the studies were presented at the annual scientific meeting of the American College of Rheumatology.

Jim Roy, Pharm-D, clinical pharmacist for Parkview Hospital in Fort Wayne, Indiana, suggests, “The studies that have been done are not large, but the preponderance of evidence from smaller studies justifies consideration of the supplements for osteoarthritis patients.”

Also not mentioned an important study published in the Archives of Internal Medicine (July 14, 2003) showed that glucosamine and chondroitin significantly improved symptoms of osteoarthritis and also improved joint mobility for 1 in 5 patients studied.

A separate study suggests glucosamine may actually slow the progression of osteoarthritis, according to The Lancet (January 24, 2001). This three-year study involved 212 people with osteoarthritis in their knees. The study found that patients who took glucosamine experienced far less deterioration than those who did not. Patients who were given glucosamine also reported decreased joint pain.

Calcium and Vitamin D

Study: Calcium with Vitamin D (CaD)
Sponsored by Women’s Health Initative, National Institutes of Health
Trial of 36,282 postmenopausal women ages 50 to 79.

Using this study and findings feels likes a filler. The findings show that Calcium and Vitamin D help PMS. Overall, the supplements were well tolerated by participants and the only adverse effect found was a 17 percent increase in kidney stones which the experts say the benefits outweigh the negligible risk.

B Vitamins

Studies: Reported in the New England Journal of Medicine
1) Heart Outcomes Prevention Evaluation-2 (HEART-2)
Sponsored by Hamilton Health Sciences - McMaster University Medical Centre, Canadian Institutes of Health Research (CIHR), and Population Health Research Institute.
HEART-2 involved 5,522 patients, age55 or older, with vascular disease or diabetes and spread across 13 countries. They were randomly assigned to take daily doses of either a placebo or a combination of 2.5 milligrams of folic acid, 50 milligrams of vitamin B-6, and 1 milligram of vitamin B-12 over an average of five years.

2) The Norwegian Vitamin Trial (NORVIT)
Sponsored by University of Tromso, The Norwegian Research Council, The Council on Health and Rehabilitation, Norway, The Norwegian Council on Cardiovascular Disease, Northern Norway Regional Health Authority, and The Norwegian Red Cross

NORVIT enrolled 3,749 men and women ages 30 to 85 years at Norwegian hospitals, each of whom had a heart attack within a week of being assigned one of four daily treatments. Some patients received a placebo while others were given either 40 milligrams of vitamin B-6; a combination of0.8 milligrams of folic acid, 0.4 milligrams of vitamin B-12 and 40 milligrams of B-6, or 0.8 milligrams of folic acid and 0.4 milligrams of B-12.

Summary. These studies did not test if Vitamin B could keep healthy people, healthy. Instead they tested people with heart disease to see if Vitamin B could treat or reverse heart disease. The HOPE-2 study did have some positive findings, including a statistically significant 25% reduction in nonfatal strokes. There are at least nine clinical trials now on-going or recently completed looking at whether B vitamins can reduce the risk of cardiovascular disease so there will be more data to review shortly.

Multivitamins

Study: National Institutes of Health, May 2006

Here are some basic flaws with the NIH findings:
1) Common multivitamins are synthetic and manufactured by Big Pharma.
2) Multivitamins could be beneficial to millions of Americans who struggle with nutrition and diet.
3) NIH used their findings to call for tighter regulations. In fact, dietary supplements have been defined by Congress as a category of food which is now more closely regulated than most other food categories. Do people get sick from eating food? Of course, in fact there are hundreds of deaths every year from food poisonings and allergic reactions. On the other hand, there are virtually no deaths from taking dietary supplements. According to date in official reports from the American Association of Poison Control Centers it is safer taking a dietary supplement than to eat a meal! Additionally, the FDA has repeatedly testified before Congress that it does not require any additional laws or changes to regulate supplements that the Dietary Supplement Health and Education Act gives them all the power that they need.

Echinacea

I believe the reporter was referencing the University of Virginia study but there is a discrepencany with the number of patients. The article lists 437 study participants but the University of Virginia study had 399 patients. There was an earlier study with 407 children.

University of Virginia Health System received a $2.2 million grant from National Institutes of Health to study Echinacea in 1992. (Note: Echinacea was listed as the 5th best-selling supplement in 1999, with sales of approx. $72 million.)

Basic flaws with this study (American Botanical Council):

1) The extracts used were made in a university laboratory and do not correlate with commercial Echinacea products currently available to consumers.
2) The dosages used are considered too low to have much value. Either higher dosage levels or more frequent dosing intervals would have been better.
3) Dosage recognized by the World Health Organization is about 330% higher than the dosage used in the study.

Note: The New England Journal of Medicine ran an editorial by Wallace Sampson, MD, a well-known opponent of integrative medicine and dietary supplements. In fact, he is a “beloved” quackbuster. On April 22, 2003, a California Appeals Court declared that Wallace Sampson MD (Scientific Review of Alternative and Aberrant Medicine) "were found to be biased and unworthy of credibility."