Action Alert: Don’t Repeal COOL

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Action Alert: Vaccinate All Children Act

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Action Alert: Protect Natural Substances

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Government Agencies Agree to Undertake Research on Folic Acid Risks

Will this convince the FDA to drop its proposed folate ban?

Last year, we reported on a proposed rule coming out of the FDA that would ban the word “folate” from Supplement Fact labels. Only “folic acid” could be listed on the labels.

We noted that the FDA’s maneuver would result in natural folate disappearing from the market entirely. If a product can only list “folic acid” as an ingredient, it would be fraudulent for it to contain anything else, even natural folate.

Folate is incredibly important to human health. Our bodies need it to synthesize and repair DNA, to produce healthy red blood cells and prevent anemia, and to support many other vital functions. Folate supplementation in pregnant women has been shown to protect against neural tube defects like anencephaly and spina bifida in children.

What we refer to as folate is the naturally occurring form of the water-soluble vitamin B9, while folic acid is the biologically inactive, synthetic form of folate. This distinction is crucial. Most people can convert folic acid to the folate that the body needs, but it is estimated that about a third of the human population cannot efficiently convert synthetic folic acid into folate. For these people, too much unmetabolized folic acid can build up in the blood, which could lead to an increased risk of prostate, lung, and colon cancer, or worsen already present cancerous lesions. This refers to very large amounts of folic acid, much larger than in current supplements, but more research is needed to account for individual differences.

In response to the proposed rule, ANH-USA submitted a formal comment to the FDA pointing to these concerns and laying the groundwork for future legal action if the agency did not change its approach. We also encouraged ANH-USA members to weigh in and demonstrate the widespread public opposition to such an action. We are happy to report that our concerns appear to have been heard!

After ANH-USA, our members, and other concerned stakeholders expressed their concerns about the FDA’s action, the National Toxicology Program (NTP) and the Office of Dietary Supplements (ODS) announced they will be conducting research into the potential adverse health effects of ingesting high levels of folic acid. ODS serves as an advisor to the FDA on issues relating to dietary supplements. NTP and ODS asked for public input on what specifically they should look into, and ANH-USA’s scientific director, Dr. Robert Verkerk, supplied a number of suggestions, such as the need for research into how much unmetabolized folic acid persists in the bloodstream in people consuming large amounts of folic acid. He also discussed the need for a better understanding of the effects of multiple genetic polymorphisms that effect the conversion of folic acid into folate.

We hope this research will cause the FDA to abandon its proposal to ban the use of the word “folate” on supplement labels, an action which could put the health of millions of Americans in jeopardy.

We will continue to monitor the situation, and will notify ANH-USA members of any further developments.

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“21st Century Cures” Bill Is Actually a Throwback to the 20th Century

This legislation reveals once again that government will always be decades behind cutting-edge healthcare, and beholden to special interests as well. Action Alert!

After a year of discussions and negotiation, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI), together with three other co-sponsors, finally released a preliminary draft of their 21st Century Cures bill.

It’s clear that the authors intend this bill to be landmark legislation to propel healthcare innovation into a new era. In a video launching their effort, Rep. DeGette said that “America can be—it must be—the healthcare innovation capitol of the world.” In the hearing that the Energy and Commerce Committee held on the draft, proponents invoked President Kennedy’s plan to go to the moon in a description of the boldness and scope of their vision.

Will this bill be the harbinger of a new era in healthcare in the United States? So far, it doesn’t look like it.

The bill is still in draft form, and significant portions of the text are still being negotiated. We had a number of criticisms of older drafts of the bill, and the good news is that a number of them were addressed in the latest draft.

The biggest victory was the elimination of several provisions that would have extended market exclusivity for Big Pharma drugs. All but one of these provisions were removed. Unfortunately, proposed language still seeks to extend the patents of drugs that were originally rejected if they can be repurposed for serious and life-threatening diseases—still a clear giveaway to Big Pharma.

We also had concerns with a provision calling for a study of patients with chronic diseases without including input from integrative doctors, since true chronic disease prevention must include nutrition and lifestyle factors. It appears that this provision has been removed.

We previously commented on the draft bill’s treatment of the antibiotics issue, which remains extremely problematic. While it appears that market exclusivity for certain antimicrobial drugs has been removed, the focus of the bill is still on developing new antibiotic drugs. The logic here makes the mind reel: the overuse of antibiotics is what has led to the current problem of antibiotic resistance, yet the answer provided by the bill’s authors is to develop more antibiotics—rather than explore natural alternatives that we’ve written about at length.

The sections dealing with vaccination remain unchanged. We would like to see a requirement that the government investigate all adverse event report (AER) data. As we reported previously, the government currently refuses to look at AERs, taking the position that correlation does not equal causation. In particular, the data about adverse events from vaccines raises some serious red flags that need to be investigated thoroughly.

The bill also includes an expedited review-and-approval process for “breakthrough vaccines,” especially in the face of public health crises, but it doesn’t put important safeguards in place to protect the public, such as informed consent or post-market studies.

The bill, even after the changes that were made, is still a far cry from the lofty rhetoric supplied by its authors about innovation and ushering in a new era of healthcare in America. It offers nothing substantially new or innovative, just more of the same outdated thinking. In our view, a real 21st century healthcare system would shift the paradigm away from healthcare modalities that don’t work and aren’t sustainable—as we’ve seen in the case of antibiotic overuse—and toward healthcare that is aimed at prevention, testing, and natural remedies. The bill’s authors stress that their intent is to put the patient at the center of care, but continue with the current government-mandated, monopoly-supported, “one-size-fits-all” approach.

Here are a few our suggestions for what a real 21st century health system would look like:

• Less emphasis on pharmaceutical interventions as the only “cure”;
• Patients and medical professionals educated on “real” disease prevention through advanced testing, diet, nutrition, exercise, and lifestyle;
• The growing problem of antibiotic-resistant “superbugs” addressed by banning antibiotic overuse on factory farms as well as their over-prescription, while encouraging the use of natural alternatives such hyperbaric oxygen therapy or treatments that include silver, intravenous vitamin C, the herbs Cat’s Claw and Artemisia, some essential oils, or grapefruit seed extract, along with much more research on natural cures;
• Improved access to natural health practitioners along with greater respect for informed choice in healthcare; and
• Endorsement of individualized medicine at the heart of the new paradigm.

We will continue to monitor this legislation as the final language gels, and we’ll let you know what is happening.

Action Alert! Write to the bill’s sponsors and ask them to make changes to the bill so it can actually live up to the name of “21st Century Cures.” Please send your message immediately.

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The FDA Appears to be Breaking the Law in Its Continuing Campaign Against Compounding

The agency seeks to remove a safe and useful compounded drug from the market without any public input. Action Alerts!

Over the last year, ANH-USA has been paying close attention to new rules that are in the process of being drafted by the FDA concerning compounded drugs—especially those rules which, if enacted, would severely limit consumer access to important compounded medications.

Recent actions by the FDA’s Compounding Advisory Committee indicate that adenosine monophosphate (AMP) could be next on the FDA’s chopping block. What’s worse is that they could be removing this and other compounds from the market illegally—because there would be no public comment period.

AMP is made naturally in every cell of the body as a byproduct of the metabolic process. When injected intramuscularly, the body converts AMP to ATP (adenosine triphosphate, the “energy molecule” which is produced by our cells’ mitochondria), where it is used as an immediate and safe form of energy.

AMP is used by integrative doctors for a number of purposes. It has been shown to be an effective treatment for multiple sclerosis and herpes labialis (cold sores). Testimonials show the effectiveness of AMP in the treatment of chronic fatigue and muscle fatigue. One patient from Dr. Jonathan Wright’s Tahoma Clinic told ANH-USA:

I have been using AMP [as I]suffer from chronic fatigue and muscle fatigue when carrying out simple tasks like hanging out the wash, brushing my teeth and making the bed.…[AMP] provides significant relief from muscle fatigue. It doesn’t take away all fatigue but it helps me to function and do tasks that I would struggle with otherwise.

Given the multiple uses and benefits of this treatment, why would the FDA seek to remove AMP from the market?

In 1997, the FDA Modernization Act called for the establishment of a list of drugs that have been withdrawn or removed from the market because they “have been found to be unsafe or not effective.” Drugs on this list would not be able to be compounded. In 1998-99, the FDA proposed and finalized an initial list of compounds for the Withdrawn or Removed list, which included adenosine phosphate. Documents from the Compounding Advisory Committee meeting at the time show that there was no safety concern with adenosine phosphate—it seems to have been included on the list because the Compounding Committee concluded that adenosine phosphate was not effective as an anti-inflammatory and a vasodilator. The committee’s discussion, as far as we can tell, did not include any mention of other therapeutic uses of adenosine phosphate or AMP.

Last year, the FDA published a proposed rulemaking and solicited public comments on a number of revisions to the Withdrawn or Removed list. One comment sought clarity on the list’s entry on adenosine phosphate: did the listing for “adenosine phosphate” include all three forms (mono-, di-, and triphosphate)? To answer this question, the FDA once again sought the advice of the Compounding Advisory Committee. The Committee concluded that the entry for adenosine phosphate should be amended to reflect that all three forms of the compound are included and may not be compounded.

It is not clear yet what the FDA will do with this recommendation. Normal procedure dictates, however, that any new inclusion on the Withdrawn or Removed list requires a proposed rulemaking so the public and other stakeholders can weigh in. If the FDA wants to include three forms of adenosine phosphate on its list, then it must go through the proper channels and give the public a chance to provide input. To our knowledge, no such rulemaking has been proposed for including AMP on the list following the Compounding Committee’s recommendation, leaving no option for the public to voice their concerns.

Apparently the FDA views public involvement on these matters as an unnecessary roadblock. Last year, the FDA proposed that future additions to the Withdrawn or Removed list not go through the rulemaking process at all, shutting out the public from having any input regarding which compounds are added to the list.

This strikes us as particularly sneaky—killing two birds (removing a helpful supplement, and keeping the public in the dark about it) with one illegal stone. The proposed rule to eliminate the public from this process has not yet been completed, so the FDA is legally required to respond to public comments on the rule and issue a revised, proposed final draft of the rule. It is therefore still illegal for the FDA to add AMP to the Withdrawn or Removed list without going through a proposed rulemaking.

We must not let the FDA and the Compounding Advisory Committee, which already have clear biases against compounding, remove important treatments from the market, especially without first going through a formal, public process.

Action Alert! Tell the FDA that they should not remove the public from decisions over what should be included on the Withdrawn or Removed list. The public has a right to voice concerns about losing access to important treatments. Please send your message immediately.

Action Alert! Write to the FDA and tell them to preserve consumer access to AMP, a treatment that has no safety concerns and has clear and demonstrable benefits to patients. Please send your message immediately.

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Government Agencies Agree to Undertake Research on Folic Acid Risks

Will this convince the FDA to drop its proposed folate ban?

Last year, we reported on a proposed rule coming out of the FDA that would ban the word “folate” from Supplement Fact labels. Only “folic acid” could be listed on the labels.

We noted that the FDA’s maneuver would result in natural folate disappearing from the market entirely. If a product can only list “folic acid” as an ingredient, it would be fraudulent for it to contain anything else, even natural folate.

Folate is incredibly important to human health. Our bodies need it to synthesize and repair DNA, to produce healthy red blood cells and prevent anemia, and to support many other vital functions. Folate supplementation in pregnant women has been shown to protect against neural tube defects like anencephaly and spina bifida in children.

What we refer to as folate is the naturally occurring form of the water-soluble vitamin B9, while folic acid is the biologically inactive, synthetic form of folate. This distinction is crucial. Most people can convert folic acid to the folate that the body needs, but it is estimated that about a third of the human population cannot efficiently convert synthetic folic acid into folate. For these people, too much unmetabolized folic acid can build up in the blood, which could lead to an increased risk of prostate, lung, and colon cancer, or worsen already present cancerous lesions. This refers to very large amounts of folic acid, much larger than in current supplements, but more research is needed to account for individual differences.

In response to the proposed rule, ANH-USA submitted a formal comment to the FDA pointing to these concerns and laying the groundwork for future legal action if the agency did not change its approach. We also encouraged ANH-USA members to weigh in and demonstrate the widespread public opposition to such an action. We are happy to report that our concerns appear to have been heard!

After ANH-USA, our members, and other concerned stakeholders expressed their concerns about the FDA’s action, the National Toxicology Program (NTP) and the Office of Dietary Supplements (ODS) announced they will be conducting research into the potential adverse health effects of ingesting high levels of folic acid. ODS serves as an advisor to the FDA on issues relating to dietary supplements. NTP and ODS asked for public input on what specifically they should look into, and ANH-USA’s scientific director, Dr. Robert Verkerk, supplied a number of suggestions, such as the need for research into how much unmetabolized folic acid persists in the bloodstream in people consuming large amounts of folic acid. He also discussed the need for a better understanding of the effects of multiple genetic polymorphisms that effect the conversion of folic acid into folate.

We hope this research will cause the FDA to abandon its proposal to ban the use of the word “folate” on supplement labels, an action which could put the health of millions of Americans in jeopardy.

We will continue to monitor the situation, and will notify ANH-USA members of any further developments.

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