Protect Estriol and Other Bioidentical Hormones

If the FDA is not dissuaded, millions of women will lose access to life-saving hormones that are often safer than the alternatives currently on the market.

How is Access to Bioidentical Hormones Threatened?

In implementing the Drug Quality and Security Act of 2013, FDA began accepting nominations to the “Difficult to Compound List.” When finalized, compounding pharmacies will no longer be able to make items that appear on this list. Bioidentical estriol, estradiol, and progesterone are crucial hormones women need when going through menopause or fertility challenges, or when struggling with other hormonal imbalances.  All three are currently nominated for the “Difficult to Compound List.” In the case of compounded bioidentical estriol, which has no FDA-approved alternative, consumer access would be eliminated if the agency places it on the list.

Estriol’s nomination is especially concerning given the FDA’s demonstrated hostility toward this hormone. In 2008, the agency ruled that pharmacies could not compound medicines containing estriol without first obtaining an investigational new drug authorization.^[1]The FDA remains unconvinced of estriol’s safety despite acknowledging that the agency is unaware of any adverse events associated with estriol^[2]in addition to the fact that this hormone has a USP monograph.^[3]The FDA’s position on estriol could be influenced by a 2005 Citizen’s Petition from a major drug manufacturer that urged the FDA to undertake enforcement actions against pharmacies producing bioidentical hormone products that competed with the drug maker’s own products.^[4]

FDA action on these three bioidentical hormones – estriol, estradiol, and progesterone – could come as early as March 2018. That is when the FDA’s Pharmacy Compounding Advisory Committee (PCAC) is next expected to meet. PCAC has the responsibility of considering FDA staff recommendations concerning all substances nominated for the “Difficult to Compound List.”

What are Bioidentical Hormones?

Unlike conventional hormone therapy that uses synthetic and animal-derived hormones that are slightly different from a woman’s own hormones, bioidentical hormones are biochemically the same as those made by the ovaries during a woman’s reproductive years. Bioidentical hormones are used chiefly to relieve and control the symptoms of menopause.

Custom-made bioidentical hormones are extremely popular with patients: up to 2.5 million US womenaged 40 years or older may use compounded hormone therapy annually, accounting for 28% to 68% of hormone therapy prescriptions.^[5]

Are Bioidentical Hormones Safe?

Yes, especially relative to some of the FDA-approved products on the market. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones.^[6]

On the other hand, studies have consistently demonstrated that synthetic hormones are associated with an increased risk of breast cancer.^[7],[8],[9]Synthetic and animal-derived hormones have also been shown to produce negative cardiovascular effects and to negate the cardio-protective effects of estrogen.^{[10],[11], [12]}

Are Bioidentical Hormones Difficult to Compound?

No. The arguments used to support the notion that bioidentical hormones are difficult to compound do not hold up to scrutiny. Extensive internal testing by pharmacies as well as third-party testing ensure that compounded hormone preparations are homogenous and reflect dosages and strengths found on the product labels. Ingredients purchased by compounders are guaranteed by the manufacturer to adhere to certain specifications. The increasing popularity of compounded hormone medicines also attests to patient and doctor satisfaction with the efficacy of these products.

Estriol in the Crosshairs

Access to estriol is particularly threatened, as there are no FDA-approved drugs for bioidentical estriol—meaning that if the FDA decides that estriol is on the “Difficult to Compound List,” patients will lose access to this hormone. Estriol has proven benefits beyond treating postmenopausal symptoms: it has been shown to reduce cardiovascular risk, help with osteoporosis, and reduce brain lesions in individuals with multiple sclerosis. Studies have also shown estriol to be safer compared with more potent estrogens.^[13]

What is ANH Seeking?

The Alliance for Natural Health (ANH) asks members of Congress send a letter to FDA directing the agency to preserve consumer access to compounded hormones that do not present safety concerns.

 

[1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3127562/

[2]https://www.researchgate.net/publication/23959867_The_Bioidentical_Hormone_Debate_Are_Bioidentical_Hormones_Estradiol_Estriol_and_Progesterone_Safer_or_More_Efficacious_than_Commonly_Used_Synthetic_Versions_in_Hormone_Replacement_Therapy

[3]http://www.pharmacopeia.cn/v29240/usp29nf24s0_m30840.html

[4]https://www.law.uh.edu/healthlaw/perspectives/2008/(BP)%20compounding.pdf

[5]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547729/

[6]https://www.researchgate.net/publication/23959867_The_Bioidentical_Hormone_Debate_Are_Bioidentical_Hormones_Estradiol_Estriol_and_Progesterone_Safer_or_More_Efficacious_than_Commonly_Used_Synthetic_Versions_in_Hormone_Replacement_Therapy

[7]https://www.ncbi.nlm.nih.gov/pubmed/15908197

[8]https://www.ncbi.nlm.nih.gov/pubmed/12419080

[9]https://www.ncbi.nlm.nih.gov/pubmed/15551359

[10]https://www.ncbi.nlm.nih.gov/pubmed/9012659

[11]https://www.ncbi.nlm.nih.gov/pubmed/6596830

[12]http://equimed.com/news/general/research-reveals-dangers-of-conjugated-equine-estrogens-for-women

[13]http://www.lifeextension.com/magazine/2008/8/Estriol-Its-Weakness-is-its-Strength/Page-01

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Protect Estriol and Other Bioidentical Hormones

If the FDA is not dissuaded, millions of women will lose access to life-saving hormones that are often safer than the alternatives currently on the market.

How is Access to Bioidentical Hormones Threatened?

In implementing the Drug Quality and Security Act of 2013, FDA began accepting nominations to the “Difficult to Compound List.” When finalized, compounding pharmacies will no longer be able to make items that appear on this list. Bioidentical estriol, estradiol, and progesterone are crucial hormones women need when going through menopause or fertility challenges, or when struggling with other hormonal imbalances.  All three are currently nominated for the “Difficult to Compound List.” In the case of compounded bioidentical estriol, which has no FDA-approved alternative, consumer access would be eliminated if the agency places it on the list.

Estriol’s nomination is especially concerning given the FDA’s demonstrated hostility toward this hormone. In 2008, the agency ruled that pharmacies could not compound medicines containing estriol without first obtaining an investigational new drug authorization.^[1]The FDA remains unconvinced of estriol’s safety despite acknowledging that the agency is unaware of any adverse events associated with estriol^[2]in addition to the fact that this hormone has a USP monograph.^[3]The FDA’s position on estriol could be influenced by a 2005 Citizen’s Petition from a major drug manufacturer that urged the FDA to undertake enforcement actions against pharmacies producing bioidentical hormone products that competed with the drug maker’s own products.^[4]

FDA action on these three bioidentical hormones – estriol, estradiol, and progesterone – could come as early as March 2018. That is when the FDA’s Pharmacy Compounding Advisory Committee (PCAC) is next expected to meet. PCAC has the responsibility of considering FDA staff recommendations concerning all substances nominated for the “Difficult to Compound List.”

What are Bioidentical Hormones?

Unlike conventional hormone therapy that uses synthetic and animal-derived hormones that are slightly different from a woman’s own hormones, bioidentical hormones are biochemically the same as those made by the ovaries during a woman’s reproductive years. Bioidentical hormones are used chiefly to relieve and control the symptoms of menopause.

Custom-made bioidentical hormones are extremely popular with patients: up to 2.5 million US womenaged 40 years or older may use compounded hormone therapy annually, accounting for 28% to 68% of hormone therapy prescriptions.^[5]

Are Bioidentical Hormones Safe?

Yes, especially relative to some of the FDA-approved products on the market. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones.^[6]

On the other hand, studies have consistently demonstrated that synthetic hormones are associated with an increased risk of breast cancer.^[7],[8],[9]Synthetic and animal-derived hormones have also been shown to produce negative cardiovascular effects and to negate the cardio-protective effects of estrogen.^{[10],[11], [12]}

Are Bioidentical Hormones Difficult to Compound?

No. The arguments used to support the notion that bioidentical hormones are difficult to compound do not hold up to scrutiny. Extensive internal testing by pharmacies as well as third-party testing ensure that compounded hormone preparations are homogenous and reflect dosages and strengths found on the product labels. Ingredients purchased by compounders are guaranteed by the manufacturer to adhere to certain specifications. The increasing popularity of compounded hormone medicines also attests to patient and doctor satisfaction with the efficacy of these products.

Estriol in the Crosshairs

Access to estriol is particularly threatened, as there are no FDA-approved drugs for bioidentical estriol—meaning that if the FDA decides that estriol is on the “Difficult to Compound List,” patients will lose access to this hormone. Estriol has proven benefits beyond treating postmenopausal symptoms: it has been shown to reduce cardiovascular risk, help with osteoporosis, and reduce brain lesions in individuals with multiple sclerosis. Studies have also shown estriol to be safer compared with more potent estrogens.^[13]

What is ANH Seeking?

The Alliance for Natural Health (ANH) asks members of Congress send a letter to FDA directing the agency to preserve consumer access to compounded hormones that do not present safety concerns.

 

[1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3127562/

[2]https://www.researchgate.net/publication/23959867_The_Bioidentical_Hormone_Debate_Are_Bioidentical_Hormones_Estradiol_Estriol_and_Progesterone_Safer_or_More_Efficacious_than_Commonly_Used_Synthetic_Versions_in_Hormone_Replacement_Therapy

[3]http://www.pharmacopeia.cn/v29240/usp29nf24s0_m30840.html

[4]https://www.law.uh.edu/healthlaw/perspectives/2008/(BP)%20compounding.pdf

[5]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547729/

[6]https://www.researchgate.net/publication/23959867_The_Bioidentical_Hormone_Debate_Are_Bioidentical_Hormones_Estradiol_Estriol_and_Progesterone_Safer_or_More_Efficacious_than_Commonly_Used_Synthetic_Versions_in_Hormone_Replacement_Therapy

[7]https://www.ncbi.nlm.nih.gov/pubmed/15908197

[8]https://www.ncbi.nlm.nih.gov/pubmed/12419080

[9]https://www.ncbi.nlm.nih.gov/pubmed/15551359

[10]https://www.ncbi.nlm.nih.gov/pubmed/9012659

[11]https://www.ncbi.nlm.nih.gov/pubmed/6596830

[12]http://equimed.com/news/general/research-reveals-dangers-of-conjugated-equine-estrogens-for-women

[13]http://www.lifeextension.com/magazine/2008/8/Estriol-Its-Weakness-is-its-Strength/Page-01

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Action Alert: Supplements are Food, Not Drugs!

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Action Alert: Supplements are Food, Not Drugs!

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Senate’s CBD Oil Rescue Offers Hope for Pain

The Senate’s version of the Farm Bill is a vast improvement on the House version, with provisions to protect organics and CBD. Action Alert!

The Senate recently released its version of the Farm Bill. For advocates of natural health, it represents a significant improvement over the House’s version of the legislation. It legalizes CBD oil and the growth of hemp; leaves out concerning provisions from the House Farm Bill regarding the regulation of pesticides, such as language that would have preempted local communities from banning pesticides and allowed more pesticides to be sprayed on organic crops; and the bill tries to address the influx of fake organic crops. We must tell our members of Congress to follow the Senate’s lead.

The best news in the Senate’s Farm Bill relates to CBD oil. The bill includes language that would legalize hemp as an agricultural commodity and remove it from the federal list of controlled substances. It also defines cannabinoids (CBD) with a THC concentration of less than 0.3% as hemp, thus legalizing CBD oil that meets the 0.3% threshold. This is an important step in our campaign to fight for consumer access to CBD oil, a cheap, safe, effective, and non-addictive alternative to opioids for pain.

Note, though, that this would only remove one of the two major threats to consumer access to CBD oil. Recall that a pharmaceutical company, GW Pharmaceuticals, has developed a CBD-based drug for a rare form of childhood epilepsy—which just received FDA approval. The FDA has said that CBD is not a supplement because GW filed an investigational new drug (IND) application on CBD before it was sold as a supplement—an agency position that we are fighting. Nonetheless, it’s encouraging that the government is proposing to remove one of the major hurdles to affordable CBD oil.

The Senate bill leaves out bad provisions that would have increased our exposure to pesticides. You can read more about those provisions in our previous coverage, but here are the highlights. The House bill included language that makes it easier to add pesticides to the list of substances that can be used on organic crops, allows farmers to spray pesticides into water (including drinking water sources), and preempts local communities from restricting the use of pesticides.

The Senate’s bill also includes provisions aimed at increasing oversight over the organic supply chain in an effort to curb the importation of fake organic grains that have been inundating the US market. Part of the problem seems to be that, while US companies importing organic products from overseas must verify that the product comes from a supplier with a valid USDA organic certificate, there isn’t a guarantee that the farm the product came from is running a legitimate organic operation. The language in the Farm Bill would require US firms importing organic goods to collect and maintain information on the product, rather than just the foreign supplier. It’s unclear whether this will really address the problem; as we’ve argued before, more regulations will not replace a will to enforce the law, which the USDA apparently lacks.  But, more serious oversight over the supply chain might help prevent some degree of fraud, so these measures could arguably help consumers.

Of course, the Senate bill includes billions of dollars in government handouts to support the growth of wheat, corn, soy, and other commodity crops—money that could be better spent supporting clean, healthy food. As we said in our coverage of the House Farm Bill, we don’t like the government picking winners and losers, but if subsidies are going to be handed out, it just makes sense not to give billions to support foods that make us unhealthy and sick.

We’re glad that the Senate bill would legalize CBD, leaves out provisions that would have expanded the use of toxic pesticides that were included in the House bill, and takes aim at fraudulent organic crops. Let’s work to make sure it stays that way.

Action Alert! Write to Congress and tell them that the Senate Farm Bill is a vast improvement over the House bill, and that you do not want the House’s pesticide provisions to be included in the final bill. Please send your message immediately.

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New Danger for Supplements?

A bill to increase oversight of certain opioids could create a new path for the federal government to ban supplements. Action Alert!

Lawmakers are considering dozens of bills aimed at addressing the crippling opioid crisis our nation is facing. One bill, the Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017, expands the power of the US Attorney General (AG) to add products to the list of controlled substances, opening another door for the federal government to remove consumer access to supplements.

Currently, controlled substances are divided into five categories, schedules 1, 2, 3, 4, and 5. The bill creates a sixth category, schedule A, and allows the US AG to either temporarily or permanently add substances to this new category with little oversight if two conditions are met: 1) the substance has a chemical structure that is “substantially similar” to the chemical structure of a controlled substance, and 2) the substance has a stimulant, depressant, or hallucinogenic effect that is “substantially similar to or greater than” that of a controlled substance.

Under normal circumstances, the US AG and the Justice Department must work with Department of Health and Human Services (HHS) and the Drug Enforcement Agency (DEA) to make additions to the controlled substances list. By law, the AG must ask HHS to conduct a scientific and medical evaluation and to make a recommendation concerning the substance the AG wants to add to a drug schedule. HHS’s recommendation is binding—if they decide the substance shouldn’t be scheduled, the AG cannot add it. The SITSA Act removes this step and allows the AG to proceed with scheduling without this input from HHS. The bill also increases the length of time a substance can be temporarily scheduled, from three to five years.

The main target of the bill appears to be synthetic opioid analogues: it adds twelve fentanyl analogues to schedule A. Our concern, however, is that the language in the bill is so broad that it creates a pathway to add natural substances to schedule A, with virtually no checks on the AGs power. Chamomile, for example, shares certain characteristics with benzodiazepine, a schedule IV drug in the US. Herbs and supplements used in natural medicine that exhibit neurological affects could be threatened, under the letter of this law. When it’s the federal government that gets to decide what is and isn’t “substantially similar” to a scheduled substance, the situation is ripe for abuse—and to further entrench Big Pharma’s monopoly over medicine by removing the competition. Usually, it’s the FDA or the FTC that goes to bat for the drug industry; now, the AG will be able to step in when these agencies can’t eliminate competition for pharmaceutical drugs.

If the government was serious about combatting the opioid crisis, it would be telling people about cheap, safe, and effective natural alternatives to opioids. There are natural alternatives to pain management, such as fish oil, sulfur-containing methylsulfonylmethane

(MSM), and cannabidiol (CBD) oil. Unfortunately, the government is making moves to remove these alternatives from the market. An FDA advisory committee voted to ban MSM medications from being made at compounding pharmacies, and the federal government is moving in on CBD oil—although there is a lifeline for CBD in the Senate’s Farm Bill. This is the kind of backwards thinking we can expect from a crony capitalist system that protects drug monopolies and throttles the competition.

Action Alert! Write to Congress and urge them to modify the SITSA Act to protect natural medicine by carving out an exemption for natural supplements and herbs. Please send your message immediately. 

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Is Your Sunscreen Making You Sick?

There’s a good chance that it is. Here are some tips on avoiding nasty chemicals when you’re out in the sun (hint: the FDA won’t help you!). Action Alert!

It’s summertime, and lots of us are spending time outdoors. When protecting yourself with sunscreen, though, it’s important to remember that many products on the market contain dangerous chemicals. The good news is there are natural alternatives, including supplements, that can help protect you without poisoning you.  Just don’t ask the FDA for more information about these healthier options; they have banned information about how cheap, safe, and effective natural medicines can protect you from the sun.

Research has shown that 96% of the US population has oxybenzone, an endocrine disruptor, in their bodies. This chemical disrupts sperm function in men and causes endometriosis (a disorder in which the tissue that normally lines the uterus grows outside the uterus) in women. The main source of exposure to this chemical? Sunscreen. Octinoxate, another chemical used in sunscreens, has been shown to cause reproductive, thyroid, and behavioral alterations in animal studies; homosalate, another sunscreen chemical, disrupts estrogen, androgen, and progesterone. Some sunscreens, even when properly used, apparently cause severe burning on young children. Mineral sunscreens, such as zinx oxide or titanium dioxide, offer a better safety profile than chemical-based sunscreens—and are better for the environment, too.

There are also nutrients that can help protect against sunburn and skin damage. Astaxanthin, a carotenoid that causes the reddish color in salmon, trout, lobster, and shrimp, has been shown to protect the skin from the harmful effects of UV radiation; a placebo-controlled, double-blinded, randomized clinical trial showed similar effects for the carotenoids lycopene and lutein. Carotenoids are also overwhelmingly safe.

Unfortunately, the FDA doesn’t want you to know about these natural alternatives. FDA Commissioner Scott Gottlieb recently announced that the FDA sent warning letters to four companies selling skin supplements. The agency argues that claims regarding the supplements’ ability to protect the skin from UV (ultraviolet) rays and sunburn turn the products into unapproved drugs, since only FDA-approved products can claim to offer broad-spectrum UV protection. Basically, to the FDA, sunburn is a disease that only FDA-approved products can treat.

Soon the FDA will be saying that dehydration is a “disease” that can only be treated with special water that has been approved as a drug by the FDA, while gagging any discussion about the benefits of tap water or “unapproved” bottled water. Where will it end? It seems the agency will stop at nothing to protect the drug industry.

This dynamic is all-too-familiar: cheap, safe, and effective natural medicine is stymied by the federal government in favor of FDA-approved, toxic products made by pharmaceutical companies. Why? Because the FDA works for the pharmaceutical industry, and anything competing with Big Pharma’s products is targeted by the agency. We can harness the power of nature to prevent illness, but nobody knows about it because the government prevents the free flow of information about these products. Are we surprised that we are facing an epidemic of chronic disease?

Tell the FDA that you want to know how cheap, safe, and effective natural medicines can protect you from the sun—and other ailments.

Action Alert! Write to the FDA and Congress and tell them to stop gagging free speech about skin supplements. Please send your message immediately.

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