The Alliance For Natural Health

The Pulse of Natural Health Newsletter

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Even More Natural Medicines Are Now at Risk

17

The FDA is likely to move against numerous natural, compounded medicines. Action Alert!

The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on what supplements and drugs can be individually formulated for patients—many of whom have very specific needs that can only be met through these alternative formulations. The next meeting of the PCAC has been announced for May 8-9, and the following substances will likely face the axe: nicotinamide adenine dinucleotide (as well as the disodium-reduced version), which plays an important role in our health (see below); nettle (Urtica dioica); ubiquinol (CoOQ10); vanadyl sulfate; and artemisinin, a critical medicine used against malaria and other diseases.

Also on the agenda is the nomination of “oral solid modified release drug products that employ coated systems”—that is, coated time-release tablets—to the “Difficult to Compound” list. As the name suggests, if a product or delivery system is added to this list, it will no longer be available from compounding pharmacies.

As has been the case in past meetings, the FDA has recommended that all of these substances be rejected. Since the PCAC almost always follows the FDA’s lead, we will need a strong response from concerned consumers if we’re to save these natural medicines.

Here’s what’s at stake:

  • Artemisinin is a compound found in sweet wormwood, an herb that has been used in traditional Chinese medicine for centuries. It is most notably used to treat malaria, but it may also be helpful for tuberculosis and a host of other conditions. Considering the rise of drug-resistant TB, which is virtually untreatable and is sending conventional doctors into a panic, it would be lunacy to restrict access to this herb.
  • Ubiquinol is by far the most effective, bioavailable form of CoQ10. Some people may not be able to convert the ubiquinone form of CoQ10 into ubiquinol, which means access to ubiquinol products is extremely important. CoQ10 / ubiquinol has many benefits—it is used for energy production by every cell in the body. It is especially useful for patients on statins since these drugs deplete the body of CoQ10.
  • Nettle has a number of salutary effects. It was used by Roman soldiers to withstand the cold by stimulating blood circulation. It helps the body detoxify itself, alleviates allergic reactions, and promotes healthy blood circulation.
  • Vanadyl sulfate is an insulin mimic and a natural therapy for diabetes and insulin resistance. It is a form of a trace mineral found in mushrooms and shellfish.
  • Nicotinamide adenine dinucleotide (NAD) is a vital compound involved in mitochondrial health and energy metabolism. As NAD levels decline later in life, mitochondrial function is impaired, resulting in various symptoms of aging. NAD is also an essential cofactor of certain key enzymes that are responsible for longevity. Every year we are learning more about how critical NAD is, including for cancer control.

Compounding pharmacies make customized, natural medicines for patients for whom it is difficult to swallow a pill (the elderly, children, and patients with disabilities, for example), as well as for patients with allergies, sensitivities to environmental contaminants and preservatives, or who require doses or delivery systems different than those of commercially available products. The ability of compounding pharmacies to function, thrive, and produce these crucial supplements plays a crucial role in people’s lives.

The FDA has repeatedly demonstrated that it is unconcerned with the needs of these vulnerable patients. Time and time again, the FDA has advised the PCAC to reject the medicines that come before it—medicines for which there is little to no safety concern, like curcumin, boswellia, and aloe vera.

It has long been our suspicion that the end goal is to eliminate the compounding industry altogether, and this is a devious way to do it—just whittle away at the ingredients that are allowed to be compounded, and it’s “death by a thousands cuts” for compounding pharmacies. And it’s all done to eliminate competition for major drug companies. We see this as yet another instance of the FDA putting the needs of Big Pharma over the health of the American people.

Action Alert! Send a message to the PCAC urging it to approve the ingredients that have been nominated to the Bulk Ingredient List—and send a copy to Congress as well. Your legislators need to see what is happening to their compounding law! Please send your message immediately.

 

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  • kentomwilson

    The FDA is at it again: suggesting that several of my natural medicines used because of my many allergies be eliminated from being sold.

  • There’s one thing I know more than anything else…man only gets away with non-common sense for just so long. One day God is going to sort this out and show men what their attitudes have been like and how it had affected thousands of people because they cared so much more about money and themselves, instead of others and their pain. Herbs were created for man and their illnesses. I have always felt that the medical field and herbal kingdom [ by working together ] could help thousands more. But first someone has got to be willing to listen and learn…then do something. And this should come from the heart, not the pocketbook or wallet.

    • Joyce Brandon

      Many modern medicines result from folk cures. Remember penicillin was developed from bread mold. Aspirin is salicylic acid which is derived from tree bark. Ancient people discovered that a tea made from this tree provided pain relief. Modern people learned how to isolate the active ingredient and developed aspirin. Nature and science are logical companions.

      • Yes very true, but I also know they boil down the real properties of natural herbs and then blend them the way they want to. Much of the real properties are gone, just like taking certain properties out of wheat and turning some breads white and calling it nutritional. I also know way back in around the late 1800, one man [ a doctor…forgot his name ] wanted so badly to see people get well faster, so he was the first to begin to create medicine by doing things similar as to what they do today. This is why I feel if nature and science got together and really learn more about the importance of the properties God had created in herbs and some how were able to keep some of those properties with in the blending of medicines, you may not see as many medicines showing up in court because of dangerous side effects. Nature is a science created by a maker that knows our bodies well and I feel we have the ability to help people get well to such a point they will feel great and be happy. With this and organic foods, much good can be done for many.

  • Bill Higgins

    After warching this same scenario play itself out time after time, I
    have come to a different conclusion. The FDA is the problem because we allow them to be. Compounders in the US rollover belly up every time the FDA restricts them, while Canadian citizens have access to these same compounds without a prescription. Non violent protest and disobedience is the answer. Compound and sell
    them anyway. They cant arrest everyone.

    • insightz

      Yes they can.

      Wait for IoT to become mainstream. Now is the time to fight back on regulatory level.

  • insightz

    Malaria…. hmmm… When Monsanto’s original patent on glyphosate run out a couple of yrs ago, this criminal enterprise that’s poisoning humanity, farm animals, and wildlife managed to patent the poison as a MALARIA DRUG, for crying out loud. Ringing any bells?

    I am not making this up.

    Devious is an understatement.

    • Dr Emmanuel Asenso

      Malaria is caused by filth in the liver and never caused by the mosquito or the plasmodium.

      • insightz

        Filth in the liver, a compromised immune system, malnutrition, lack of Vitamin D (due to sun’s being filtered by our misguided efforts at climate modification)… all valid causes. Many of the affected individuals can’t read up on the net about safe methods of liver detox (even though they can harvest many of the plants we have to buy in pill form to do just that) for lack of access. Now they’ll be doused with glyphosate.

        A couple of years ago, former president Jimmy Carter made headlines for his efforts at eradicating the mosquitoes that serve as the carriers of plasmodium — his certainly well-meaning efforts require poisoning lakes and waterways with chemicals that supposedly kill mosquitoes (never mind they bio-accumulate causing mayhem in the ecosystem). What happened to populating waterways with FISH that feed on mosquito larvae, can’t we do that anymore? Oh wait, that’s not patentable, and no one would get to “donate” toxic chemicals so Carter’s charities could dump them into African lakes.

        Bottom line: human greed is the root cause of malaria.

        • Dr Emmanuel Asenso

          That is not the true facts

        • Joyce Brandon

          A tropical parasite causes malaria. In Africa, it is endemic. The providing of mosquito netting is helping. A missionary friend who lived in the Congo for 30 years contracted it and will have it for the rest of her life. Periodically, it makes her ill.

        • Joyce Brandon

          How does greed cause disease? Pollution, poor hygiene, lack of proper sanitation, bacteria, viruses, parasites, malnutrition, dirty drinking water cause disease. I probably forgot some.
          Personally, I question your claim to be a physician. Will be interesting to see your credentials and read the article you mentioned.
          If they aren’t forthcoming, I will presume you are a charlatan. My husband thinks you are a quack. Truth will tell.

      • Joyce Brandon

        My microbiologist husband just said that malaria is caused by the parasite called plasmodium which is carried by mosquitoes that live in tropical regions. Quinine is the preventative medication. Dad had to take this when fighting in the South Pacific during WW2. Are you an MD or a PhD.? He asked because your response alarms him.

        • Dr Emmanuel Asenso

          Are you ready to test the thesis? Get the two groups of malaria patients and follow the MNMP protocols. It is simply a myth to believe that malaria is caused by the mosquito and or the plasmodium. By the way is it only MDs, or PHDs or DOs or DMs who have access to the truth in this world? Question: What does the plasmodium do in the liver in a pleomorphic environment?. God created a self-healing body and it is filth or poisons or toxins that make people sick! Fact: Malaria is a Liver disease synonymous to a filthy liver – This was published in May of 2014 across the globe. I hope this helps

          • Joyce Brandon

            I’ll have my microbiologist husband read this and take it to the ASM convention in a few weeks. He will want your credentials: degrees, university graduated from. That’s probably enough to verify your expertise.Malaria is rare in our northern climate, so he personally hasn’t dealt with it. However, the convention is attended by Microbiologists from all over the world. Do you have any insight on the Zika virus?
            Curiosity: what causes strep throat? There is someone on this site who has it. The obvious answer is the streptococcus bacteria my husband isolates, then does a susceptibility test to determine the most effective antibiotic.
            He had never heard the term filthy liver. Can you explain it? He is going to ask his infectious disease doctor and pathologist.
            From me: do you believe in the existence of bacteria and viruses? Parasites are presumably a given. Which publication in 2014? He can find and read it.
            Thanks.

          • Dr Emmanuel Asenso

            My credentials are wisdom and common sense from God. Do a search on the net on ” monomorphism vrs pleomorphism and you will understand the true meaning of sickness. All healing comes from nature through the mighty power of God. How do the animals in the wild heal themselves?
            Excuse me it is seriously impolite and rude to associate me with quackery especially when you have no idea about my person. A quack is an individual who has a degree of ignorance and is not humble enough to listen and investigate new ideas! Thank you all for calling me a quack.
            Unfortunately many people have been programmed to be sick and also are living in ignorance and have also acquired degrees of ignorance. I am not one of them. Authoritative misinformation on serious matters of health is making many people needlessly sick and dying prematurely.
            Who said this” The school system does two main things – Confer degrees and Conceal valuable knowledge”
            One serious problem with ignorance is to disbelieve something for the first time of a fact you are clueless. At least I know myself and I am not ignorant.
            Pray to God for the true light to open your eyes. And this is my last communication with all for I am convinced that you have been programmed to hate the truth!

        • Megan Abraham

          ALERT! Emmanuel Asenso is a quack doctor who attended the defunct Clayton college of natural health “the Biggest Quack School in Natural Medicine”, -Huffington Post. He also attended another nonaccredited correspondence school: The International School of Detoxification Florida. Dr. Morse who runs the program claims a Ph.D. from the Brantridge Forest School, a diploma mill in England. Emmanuel Asenso has been misleading people with his fake medical statements and misrepresentations. This is very dangerous to public health and safety. The FDA must take action now!