alliancefornaturalhealth--2020-05-07--COVID Quickens Antibiotic Resistance

COVID Quickens Antibiotic Resistance

This pandemic is exacerbating a big problem , but natural alternatives are still ignored .
Action Alert !
Antibiotics are being widely used in hospitals around the world to treat or prevent secondary infections in COVID-19 patients .
This will make the problem of antibiotic resistance much worse and lead to many deaths .
Natural alternatives to treat bacterial infections exist , but they are ignored by government and the medical establishment .
Researchers around the world are sounding the alarm about the problem of antibiotic resistance during the COVID pandemic .
Patients hospitalized for COVID-19 are at great risk @ @ @ @ @ @ @ but to secondary bacterial infections .
A Chinese study of 191 patients in Wuhan showed that 50 % of those who died had a secondary infection .
Nearly all severe COVID-19 patients will receive antibiotics .
More antibiotic use means more of the medicines currently being used become less effective or even useless .
With every dose of antibiotics given to a patient , some bacteria survive , and these surviving strains multiply and evolve into resistant superbugs .
Superbugs infect one American every 11 seconds and kill one every 15 minutes .
@ @ @ @ @ @ @ COVID-19 pandemic threatens to further weaken the already crumbling antibiotic infrastructure.
” Resistant infections cause 700,000 deaths worldwide each year .
By 2050 , they are expected to kill 10 million people each year .
Hospitals are particularly dangerous for this : hospital-acquired infections kill 90,000 people a year .
MRSA alone infects 90,000 people and kills 20,000 a year .
It is maddening to see conventional medicine continue to rely on drugs when there are potent natural options available to fight these deadly illnesses .
• We ’ ve reported on the @ @ @ @ @ @ @ world ’ s oldest known antibiotic .
• Researchers have reported that CBD , one of the compounds found in hemp , has shown promise against antibiotic resistant infections such as methicillin-resistant S. aureus ( MRSA ) • Two studies have now linked vitamin D to the successful prevention and treatment of tuberculosis ( TB ) .
In the first study , white blood cells converted vitamin D to an active form of the vitamin , which helps make a protein that kills the TB bacterium .
In the second study , Indonesian @ @ @ @ @ @ @ , testing both on seventy patients for nine months .
The patients who received 10,000 IU of vitamin D ( rather than the 600 IU recommended by conventional medicine ) had an astounding 100 % cure rate .
• Some evidence suggests that vitamin C could be effective in fighting antibiotic resistant infections .
• There have also been studies showing that ozone therapy—which increases the amount of oxygen in the body—can be an effective treatment for TB .
• An Italian study found that thyme and clove essential oils were effective in @ @ @ @ @ @ @ study found tea-tree oil was a more effective treatment for staph-infected wounds than conventional treatments .
Russell Blaylock , MD , a leading integrative physician , discussed several important studies on silver in his May 2016 newsletter : • One study found that adding just a small amount of nano-sized silver to antibiotics made the treatment much more potent in killing a resistant type of bacteria .
• Subsequent studies showed that this approach was not harmful to human cells .
Animal studies showed that the toxicity that can result from higher concentrations @ @ @ @ @ @ @ silymarin ( from milk thistle ) and vitamin E in conjunction with the silver .
• Nanosilver can also destroy the bacterium ’ s biofilm—a protective organic coating that helps protect the bacteria from antibiotics .
One study showed that nanosilver destroyed the biofilm , making the bacteria susceptible to lower doses of antibiotics .
Researchers found this strategy to be effective against some of the most dangerous bacteria .
Natural alternatives are clearly supported by good research .
But sadly , research doesn ’ t seem to be enough .
Silver , @ @ @ @ @ @ @ not be patented , and so can not make billions for drug companies .
Then , to prevent these treatments from competing on a level playing field with drugs , the FDA bars the public from learning about their benefits .
Action Alert !
Tell the FDA , with a copy to Congress , to advise healthcare professionals on the use of natural antibiotic treatments .
Please send your message immediately .

This pandemic is exacerbating a big problem, but natural alternatives are still ignored. Action Alert!
Antibiotics are being widely used in hospitals around the world to treat or prevent secondary infections in COVID-19 patients. This will make the problem of antibiotic resistance much worse and lead to many deaths. Natural alternatives to treat bacterial infections exist, but they are ignored by government and the medical establishment.
Researchers around the world are sounding the alarm about the problem of antibiotic resistance during the COVID pandemic. Patients hospitalized for COVID-19 are at great risk of succumbing not only to the virus but to secondary bacterial infections. A Chinese study of 191 patients in Wuhan showed that 50% of those who died had a secondary infection. Nearly all severe COVID-19 patients will receive antibiotics.
More antibiotic use means more of the medicines currently being used become less effective or even useless. With every dose of antibiotics given to a patient, some bacteria survive, and these surviving strains multiply and evolve into resistant superbugs. Superbugs infect one American every 11 seconds and kill one every 15 minutes. One researcher warns that “the current COVID-19 pandemic threatens to further weaken the already crumbling antibiotic infrastructure.”
Resistant infections cause 700,000 deaths worldwide each year. By 2050, they are expected to kill 10 million people each year. Hospitals are particularly dangerous for this: hospital-acquired infections kill 90,000 people a year. MRSA alone infects 90,000 people and kills 20,000 a year.
It is maddening to see conventional medicine continue to rely on drugs when there are potent natural options available to fight these deadly illnesses.
For example:
We’ve reported on the anti-pathenogenic properties of colloidal silver, the world’s oldest known antibiotic.
the anti-pathenogenic properties of colloidal silver, the world’s oldest known antibiotic. Researchers have reported that CBD, one of the compounds found in hemp, has shown promise against antibiotic resistant infections such as methicillin-resistant S. aureus (MRSA)
that CBD, one of the compounds found in hemp, has shown promise against antibiotic resistant infections such as methicillin-resistant S. aureus (MRSA) Two studies have now linked vitamin D to the successful prevention and treatment of tuberculosis (TB). In the first study , white blood cells converted vitamin D to an active form of the vitamin, which helps make a protein that kills the TB bacterium. In the second study , Indonesian scientists compared vitamin D to a placebo, testing both on seventy patients for nine months. The patients who received 10,000 IU of vitamin D (rather than the 600 IU recommended by conventional medicine) had an astounding 100% cure rate.
, white blood cells converted vitamin D to an active form of the vitamin, which helps make a protein that kills the TB bacterium. In the , Indonesian scientists compared vitamin D to a placebo, testing both on seventy patients for nine months. The patients who received 10,000 IU of vitamin D (rather than the 600 IU recommended by conventional medicine) had an astounding 100% cure rate. Some evidence suggests that vitamin C could be effective in fighting antibiotic resistant infections.
that vitamin C could be effective in fighting antibiotic resistant infections. There have also been studies showing that ozone therapy—which increases the amount of oxygen in the body—can be an effective treatment for TB.
showing that ozone therapy—which increases the amount of oxygen in the body—can be an effective treatment for TB. An Italian study found that thyme and clove essential oils were effective in treating bacterial vaginosis.
found that thyme and clove essential oils were effective in treating bacterial vaginosis. A US study found tea-tree oil was a more effective treatment for staph-infected wounds than conventional treatments.
found tea-tree oil was a more effective treatment for staph-infected wounds than conventional treatments. Additional research found that lemongrass oil could reduce MRSA.
Russell Blaylock, MD, a leading integrative physician, discussed several important studies on silver in his May 2016 newsletter:
One study found that adding just a small amount of nano-sized silver to antibiotics made the treatment much more potent in killing a resistant type of bacteria.
that adding just a small amount of nano-sized silver to antibiotics made the treatment much more potent in killing a resistant type of bacteria. Subsequent studies showed that this approach was not harmful to human cells. Animal studies showed that the toxicity that can result from higher concentrations of silver can be avoided by administering silymarin (from milk thistle) and vitamin E in conjunction with the silver.
showed that this approach was not harmful to human cells. showed that the toxicity that can result from higher concentrations of silver can be avoided by administering silymarin (from milk thistle) and vitamin E in conjunction with the silver. Nanosilver can also destroy the bacterium’s biofilm—a protective organic coating that helps protect the bacteria from antibiotics. One study showed that nanosilver destroyed the biofilm, making the bacteria susceptible to lower doses of antibiotics. Researchers found this strategy to be effective against some of the most dangerous bacteria.
Natural alternatives are clearly supported by good research. But sadly, research doesn’t seem to be enough. Silver, essential oils, and vitamin C cannot be patented, and so cannot make billions for drug companies. Then, to prevent these treatments from competing on a level playing field with drugs, the FDA bars the public from learning about their benefits.
Action Alert! Tell the FDA, with a copy to Congress, to advise healthcare professionals on the use of natural antibiotic treatments. Please send your message immediately.


alliancefornaturalhealth--2020-05-14--Your COVID Risk Assessment: A Look at the Numbers

What we know so far about who ’ s at risk for COVID-19—and why the government isn ’ t doing more to protect us .
Action Alert !
Factors such as age , gender , race and underlying medical conditions make this virus much more dangerous for some , less so for others .
Given these different risks , the government should be funding research into how we can protect ourselves from COVID-19 infection with nutrition and lifestyle changes , but they ignore these approaches because they don ’ t make money for drug companies .
What are your risk @ @ @ @ @ @ @ % of the population , but only 7 % of confirmed cases .
Children with the virus tend to develop symptoms like fever and cough at a lower rate ( 73 % ) compared to adults ( 93 % ) .
• However , a mysterious inflammatory illness seems to be afflicting children and is believed to be linked to COVID-19 infection .
• Infants , unlike children , are a high-risk group .
Of the 95 infants in the CDC study , 62 % were hospitalized , compared to 14 % among @ @ @ @ @ @ @ that people younger than 30 years were 40 % less likely to die of the infection than those 30 to 59 years .
• The share of fatalities among those infected rises significantly by age group : The chart above was originally posted here and uses data provided by New York Health detailing age-related deaths , comorbidities and deaths among those whose ages were not identified .
• While the US does not currently have gender related statistics available , data from around the world confirms that men are more than twice as @ @ @ @ @ @ @ women .
• The number of those infected is evenly distributed between genders ( though data is incomplete due to lack of reporting data from US and other countries ) .
• Studies indicate that estrogen may play a protective role during Covid-19 infection .
• 42 % of deaths from the pandemic , so far , were African Americans , who comprise just over 12 % of the total population ; African Americans comprise nearly a third of confirmed infections ; 80 % of those hospitalized for COVID-19 in Georgia were African @ @ @ @ @ @ @ surveyed were concerned they would be infected , compared to 60 % among blacks and 50 % among whites .
• Air pollution and toxic exposures increase the risk of COVID-19 and minorities are more likely to be exposed to higher levels of toxins .
People of color are exposed to 38 % higher levels of carbon dioxide , which contribute to respiratory problems .
• According to CDC , 90 % of those hospitalized for COVID have an underlying health condition .
• Obese patients under 60 were twice as likely to @ @ @ @ @ @ @ not obese .
• Mortality rates for COVID patients with diabetes ( 100 million+ Americans have the disease ) is three times higher than those without diabetes ; people with diabetes are not more likely to contract the virus , but face worse outcomes once infected .
• Cardiovascular disease is the deadliest and most common comorbidity among those hospitalized .
• Because cancer treatments weaken the immune system , patients who have cancer are at a higher risk of developing serious complications from Covid-19 .
Those suffering from immune diseases also face @ @ @ @ @ @ @ targeted asthma as a potentially risky comorbidity , but emerging data suggests asthmatics might not be at higher risk .
• Individuals with Type A blood have a higher risk for COVID as compared with non-A blood groups .
Type O type risks are significantly lower .
• There is no reported increase in risk among pregnant women .
This is what we know so far .
Unfortunately , those who are at higher risk are not being given much advice about how to protect themselves other than “ stay at home ” @ @ @ @ @ @ @ government should 1 ) be telling people about natural ways of shoring up the body ’ s immune defenses , such as correcting nutrient deficiencies that millions of Americans suffer from , and 2 ) committing serious funding to research looking at how diet and lifestyle factors impact COVID-19 infection and resistance .
The time to do these studies is now , not months or years later .
We must force the government to act .
Action Alert !
Tell the NIH , with a copy to Congress , to fund studies of @ @ @ @ @ @ @ Please send your message immediately .

What we know so far about who’s at risk for COVID-19—and why the government isn’t doing more to protect us. Action Alert!
Factors such as age, gender, race and underlying medical conditions make this virus much more dangerous for some, less so for others. Given these different risks, the government should be funding research into how we can protect ourselves from COVID-19 infection with nutrition and lifestyle changes, but they ignore these approaches because they don’t make money for drug companies.
What are your risk factors?
Age
Children make up 22% of the population, but only 7% of confirmed cases . Children with the virus tend to develop symptoms like fever and cough at a lower rate (73%) compared to adults (93%).
. Children with the virus tend to develop symptoms like fever and cough at a (73%) compared to adults (93%). However, a mysterious inflammatory illness seems to be afflicting children and is believed to be linked to COVID-19 infection.
seems to be afflicting children and is believed to be linked to COVID-19 infection. Infants, unlike children, are a high-risk group. Of the 95 infants in the CDC study , 62% were hospitalized, compared to 14% among 1- to 17-year-olds.
, 62% were hospitalized, compared to 14% among 1- to 17-year-olds. Researchers found that people younger than 30 years were 40% less likely to die of the infection than those 30 to 59 years.
that people younger than 30 years were 40% less likely to die of the infection than those 30 to 59 years. The share of fatalities among those infected rises significantly by age group:
The chart above was originally posted here and uses data provided by New York Health detailing age-related deaths, comorbidities and deaths among those whose ages were not identified.
Gender
While the US does not currently have gender related statistics available, data from around the world confirms that men are more than twice as likely to die from the virus as women.
from the virus as women. The number of those infected is evenly distributed between genders (though data is incomplete due to lack of reporting data from US and other countries).
between genders (though data is incomplete due to lack of reporting data from US and other countries). Studies indicate that estrogen may play a protective role during Covid-19 infection.
Race
Underlying Health Issues
According to CDC, 90% of those hospitalized for COVID have an underlying health condition.
of those hospitalized for COVID have an underlying health condition. Obese patients under 60 were twice as likely to need acute care as those who are not obese.
patients under 60 were twice as likely to need acute care as those who are not obese. Mortality rates for COVID patients with diabetes (100 million+ Americans have the disease) is three times higher than those without diabetes; people with diabetes are not more likely to contract the virus, but face worse outcomes once infected.
than those without diabetes; people with diabetes are not more likely to contract the virus, but face worse outcomes once infected. Cardiovascular disease is the deadliest and most common comorbidity among those hospitalized.
and comorbidity among those hospitalized. Because cancer treatments weaken the immune system, patients who have cancer are at a higher risk of developing serious complications from Covid-19. Those suffering from immune diseases also face this increased risk.
are at a higher risk of developing serious complications from Covid-19. Those suffering from also face this increased risk. Early reports targeted asthma as a potentially risky comorbidity, but emerging data suggests asthmatics might not be at higher risk.
suggests asthmatics might not be at higher risk. Individuals with Type A blood have a higher risk for COVID as compared with non-A blood groups. Type O type risks are significantly lower.
have a higher risk for COVID as compared with non-A blood groups. Type O type risks are significantly lower. There is no reported increase in risk among pregnant women.
This is what we know so far. Unfortunately, those who are at higher risk are not being given much advice about how to protect themselves other than “stay at home” and “wash your hands.” The government should 1) be telling people about natural ways of shoring up the body’s immune defenses, such as correcting nutrient deficiencies that millions of Americans suffer from, and 2) committing serious funding to research looking at how diet and lifestyle factors impact COVID-19 infection and resistance. The time to do these studies is now, not months or years later. We must force the government to act.
Action Alert! Tell the NIH, with a copy to Congress, to fund studies of natural ways of preventing COVID-19 infection. Please send your message immediately.


alliancefornaturalhealth--2020-05-14--Household Products That Increase Risk From COVID

Exposure to a slew of toxic chemicals is making us sick , increasing COVID infections , and ushering in an era of male infertility .
Action Alert !
Exposures to every day chemicals are making us more susceptible to infection by the COVID-19 virus .
Endocrine disrupting chemicals are found in food packaging , cookware , plastics , and many other consumer products .
These chemicals are linked to the very diseases that increase our risk of serious COVID-19 infection .
Government agencies like the FDA and EPA continue to ignore the clear dangers posed by these chemicals—another example of @ @ @ @ @ @ @ puts American lives at risk .
Chronic disease in the US has been on the rise for 50 years and coincides with an increase in our exposure to chemicals in common consumer products .
Endocrine disrupting chemicals have been shown to interfere with immune function and the regulation of inflammation .
Research is increasingly linking many of COVID comorbid diseases to environmental , as well as genetic , causes ; thousands of scientific papers have been published over the last two decades linking endocrine disruptor exposure to the very comorbidities that increase the @ @ @ @ @ @ @ reported recently on research demonstrating that our increased exposure to toxins like BPA may account for a staggering 90 % of diabetes cases .
Hormones are crucial to many important bodily functions .
They determine our development and behavior .
A small change in hormone concentration—the equivalent of one drop of water in 20 Olympic-sized swimming pools—is enough to have an effect on the human endocrine system , which impacts growth , metabolism , sleep , and other important bodily functions .
This means that even low exposures to BPA , PFAS ( @ @ @ @ @ @ @ and other ubiquitous endocrine disruptors could have profound human health consequences .
Just how profound ?
The US is one of the unhealthiest nations in the world .
Almost 43 % of Americans over age 20 are obese , which is far , far higher than any other country with high rates of COVID infection : Japan ’ s adult obesity rate is only 3.7 % , Korea ’ s is 5.3 % , China ’ s is 7 % , and Italy ’ s is 9.8 % The US ranks 43rd out @ @ @ @ @ @ @ lung disease ; leads developed nations in type 2 diabetes ; has the third highest mortality rate for circulatory diseases like high blood pressure ; and is second highest in mortality rate for heart attacks .
There are other factors that make us such a profoundly sick nation , such as the government subsidizing calorie-dense , nutrient poor junk foods .
But our increased exposure to a wide array of dangerous chemicals in almost every aspect of our lives is almost certainly a key factor in our high rates of chronic illness , @ @ @ @ @ @ @ is another grave danger posed by endocrine disruptors unrelated to COVID-19 : male infertility .
One researcher bluntly stated , “ Not everyone who wants to reproduce will be able to.
” There ’ s a great deal of evidence that points to endocrine disruptors as a major cause of this problem .
One study found an association between higher concentrations of phthalates ( a chemical used in plastics ) and increased damage to sperm DNA .
Another study by Canadian scientists found that adding endocrine disruptors to Lake Ontario turned male fathead @ @ @ @ @ @ @ both male and female characteristics ) , which are unable to reproduce .
Unfortunately , these are far from the only studies positing a link between chemicals and infertility .
The best way to deal with these toxins is to avoid them as best we can , but this can be challenging given that they can be found in unexpected places , such as dental offices ( there is BPA in dental sealants ) and checkout receipts .
Other strategies for detoxification include increasing glutathione production , increasing dietary fiber , and toxin-specific @ @ @ @ @ @ @ .
But avoidance is best ; once in the body , these chemicals can be difficult to get rid of , as they store and accumulate in fat .
The toll these chemicals are taking on human health is far too high .
There is some momentum on Capitol Hill to regulate PFAS chemicals in light of the EPA ’ s inaction , but due no doubt to chemical industry influence , the measure has been reported to have “ no prospects ” in the Senate .
We must hammer our policy makers @ @ @ @ @ @ @ well as other endocrine disrupting chemicals .
Action Alert !
Write to the FDA , EPA , and Congress , telling them to ban PFAS and other endocrine disruptors .
Please send your message immediately .

Exposure to a slew of toxic chemicals is making us sick, increasing COVID infections, and ushering in an era of male infertility. Action Alert!
Exposures to every day chemicals are making us more susceptible to infection by the COVID-19 virus. Endocrine disrupting chemicals are found in food packaging, cookware, plastics, and many other consumer products. These chemicals are linked to the very diseases that increase our risk of serious COVID-19 infection. Government agencies like the FDA and EPA continue to ignore the clear dangers posed by these chemicals—another example of the cronyism and deference to industry that puts American lives at risk.
Chronic disease in the US has been on the rise for 50 years and coincides with an increase in our exposure to chemicals in common consumer products. Endocrine disrupting chemicals have been shown to interfere with immune function and the regulation of inflammation. Research is increasingly linking many of COVID comorbid diseases to environmental, as well as genetic, causes; thousands of scientific papers have been published over the last two decades linking endocrine disruptor exposure to the very comorbidities that increase the risk of dying from COVID-19. We reported recently on research demonstrating that our increased exposure to toxins like BPA may account for a staggering 90% of diabetes cases.
Hormones are crucial to many important bodily functions. They determine our development and behavior. A small change in hormone concentration—the equivalent of one drop of water in 20 Olympic-sized swimming pools—is enough to have an effect on the human endocrine system, which impacts growth, metabolism, sleep, and other important bodily functions. This means that even low exposures to BPA, PFAS (so-called “forever chemicals”), and other ubiquitous endocrine disruptors could have profound human health consequences.
Just how profound? The US is one of the unhealthiest nations in the world. Almost 43% of Americans over age 20 are obese, which is far, far higher than any other country with high rates of COVID infection: Japan’s adult obesity rate is only 3.7%, Korea’s is 5.3%, China’s is 7%, and Italy’s is 9.8% The US ranks 43rd out of 183 countries for death due to lung disease; leads developed nations in type 2 diabetes; has the third highest mortality rate for circulatory diseases like high blood pressure; and is second highest in mortality rate for heart attacks.
There are other factors that make us such a profoundly sick nation, such as the government subsidizing calorie-dense, nutrient poor junk foods. But our increased exposure to a wide array of dangerous chemicals in almost every aspect of our lives is almost certainly a key factor in our high rates of chronic illness, making us vulnerable to COVID-19.
There is another grave danger posed by endocrine disruptors unrelated to COVID-19: male infertility. One researcher bluntly stated, “Not everyone who wants to reproduce will be able to.” There’s a great deal of evidence that points to endocrine disruptors as a major cause of this problem. One study found an association between higher concentrations of phthalates (a chemical used in plastics) and increased damage to sperm DNA. Another study by Canadian scientists found that adding endocrine disruptors to Lake Ontario turned male fathead minnows into intersexual fish (fish with both male and female characteristics), which are unable to reproduce. Unfortunately, these are far from the only studies positing a link between chemicals and infertility.
The best way to deal with these toxins is to avoid them as best we can, but this can be challenging given that they can be found in unexpected places, such as dental offices (there is BPA in dental sealants) and checkout receipts. Other strategies for detoxification include increasing glutathione production, increasing dietary fiber, and toxin-specific interventions to prevent damage and facilitate detoxification. But avoidance is best; once in the body, these chemicals can be difficult to get rid of, as they store and accumulate in fat.
The toll these chemicals are taking on human health is far too high. There is some momentum on Capitol Hill to regulate PFAS chemicals in light of the EPA’s inaction, but due no doubt to chemical industry influence, the measure has been reported to have “no prospects” in the Senate. We must hammer our policy makers with messages demanding action on PFAS as well as other endocrine disrupting chemicals.
Action Alert! Write to the FDA, EPA, and Congress, telling them to ban PFAS and other endocrine disruptors. Please send your message immediately.


alliancefornaturalhealth--2020-05-14--Natural COVID Treatments: Cronyism Stands in the Way

We need your help to get this message out far and wide .
Sending this article to five people you know would do a tremendous service and help get everyone ’ s , including the government ’ s , attention .
Please help us .
Action Alert !
Write to Congress and the National Institutes of Health , demanding further study on promising natural treatments for COVID-19 .
Please send your message immediately .
Over the last few weeks , we ’ ve been reporting on promising natural options for preventing and treating COVID-19 infection .
Based on conversations with @ @ @ @ @ @ @ there are natural products that could be further developed to provide a complete cure for many diseases , including viruses , killer viruses , cancers , and even heart disease .
The problem is that because these products are natural , they are not readily patentable , and not being readily patentable , nobody will fund the billions of dollars required for research and especially for FDA approval .
We must demand that the government change the rules so that the research and approval process no longer costs billions .
There are currently @ @ @ @ @ @ @ on the government ’ s website looking at COVID-19 ; of those , there are only a small handful of trials assessing the efficacy of natural medicines for COVID-19 .
Many of these trials are poorly designed , with intravenous vitamin C ( IVC ) being the perfect example .
There are a number of trials looking at IVC for COVID-19 , but the doses are generally far too small , well below the doses that have been given to cancer patients ( which can be up to 100g infusions , compared to @ @ @ @ @ @ @ High doses are required to achieve peak blood levels to generate hydrogen peroxide which , even in small amounts , can inactivate coronaviruses .
Although reports indicate that these lower doses of IVC help patients get out of intensive care units sooner , there was no proven effect on mortality .
To save lives adequate levels of IVC should be properly studied as a COVID-19 treatment .
This is just one example among many .
Most promising treatments are not being studied at all and have little chance of attracting the necessary attention @ @ @ @ @ @ @ approval process standing in the way .
Here are a few key examples of items that have tremendous potential but are being ignored by Pharma and its allies in government : • Potassium appears to be another key nutrient implicated in COVID-19 cases .
Preliminary data show that COVID-19 patients exhibit hypokalemia ( low potassium in the blood ) and that potassium supplementation assisted recovery .
Note that a national survey of 16,444 Americans found that 100 % were not getting the estimated average requirement ( EAR ) of potassium ( EAR is @ @ @ @ @ @ @ which the needs of 50 percent of the population will be met ) .
This critical nutrient could be saving lives right now , but the government is only focused on pharmaceutical interventions that can make drug companies rich .
• There is promising initial data regarding zinc , quercetin , and epigallocatechin-gallate ( EGCG ) .
High concentrations of zinc inside cells inhibit the replication of RNA viruses such as COVID-19 , but due to zinc ’ s other characteristics , cells do not typically tolerate high levels of this mineral .
@ @ @ @ @ @ @ zinc into cells , much like the drug chloroquine ( which when studied in combination with zinc ) proved useful while when studied alone did not ) .
Unlike chloroquine , quercetin and EGCG do not have dangerous or potentially even fatal side-effects .
Note too that quercetin itself has anti-viral properties .
There have already been animal trials on the zinc/quercetin combination for use against Ebola and SARS-CoV1 , and human clinical trials have been approved by the FDA .
There is only one small trial in Turkey that is looking at @ @ @ @ @ @ @ researchers believe that zinc in general is one of the most important things we can take both to avoid Covid-19 infection and treat it .
• Oregano oil and monolaurin are candidates to target the viral capsule of coronaviruses .
Monolaurin is being studied in the Philippines , but is ignored by the US government .
• Silver , particularly nebulized silver , also has potential as an anti-viral or to prevent follow up bacterial infections .
Crucially , evidence shows that silver hydrosol may be effective against certain strains of coronavirus like @ @ @ @ @ @ @ other viruses like HIV and herpes .
Meanwhile both the FDA and the FTC are refusing to allow any claims for silver at all .
• Vitamin D is a key immune system regulator .
People with especially low D are more vulnerable to Covid-19 .
Research has also shown that low vitamin D is linked with worse COVID-19 outcomes .
Our government should be getting this information out to everyone , but refusing even to discuss it .
These are just a few of the many promising natural therapies suggested by integrative @ @ @ @ @ @ @ can consult our previous articles for more information .
Here are some further examples : • Data show that dietary selenium is linked with COVID-19 outcomes : a study found that patients in areas with high levels of selenium were more likely to recover from the virus , while places with lower selenium intake had a death rate five times higher .
• Many supplements ( curcumin , resveratrol , luteolin etc . )
are candidates to help control the cytokine storm that may kill Covid-19 patients but are not being tested for @ @ @ @ @ @ @ from the immune system using a substance called nagalase .
Some supplements , especially probiotics , are candidates to help control nagalase but are also unlikely to be tested for this use .
• Other supplements , like the herb Andrographis paniculate , are candidates to interfere with enzymes needed by the virus to reproduce but are also unlikely ever to be tested for this use .
• Drugs like proton pump inhibitors can increase the likelihood of serious infection with COVID-19 .
Shouldn ’ t millions of users be told ?
Our @ @ @ @ @ @ @ other supplements that may be helpful for prevention or treatment , including melatonin , NAC , beta glucans , garlic , and vitamin A .
Our government now touts a drug , remdesivir , as the new “ standard of care , ” the mortality rate of which is not statistically different from placebo .
Why ?
Because it is a new drug that can make a fortune for the pharmaceutical manufacturer ?
None of the natural treatments listed above can be easily patented , so no company can afford to pay for @ @ @ @ @ @ @ from the escalating costs of this pandemic , how can we continue to focus primarily on expensive drugs and ignore affordable micronutrients that show such promise ?
Our government ’ s response to the COVID-19 pandemic is a case-study in crony capitalist medicine .
We need thorough studies on these promising natural treatments to assess their viability for COVID-19 , and it must happen now .
We need your help to get this message out far and wide .
Sending this article to five people you know would do a tremendous service and @ @ @ @ @ @ @ .
Please help us .
Action Alert !
Write to Congress and the National Institutes of Health , demanding further study on promising natural treatments for COVID-19 .
Please send your message immediately .

We need your help to get this message out far and wide.
Sending this article to five people you know would do a tremendous service and help get everyone’s, including the government’s, attention. Please help us.
Action Alert! Write to Congress and the National Institutes of Health, demanding further study on promising natural treatments for COVID-19. Please send your message immediately.
Over the last few weeks, we’ve been reporting on promising natural options for preventing and treating COVID-19 infection. Based on conversations with highly credentialed scientists, we believe that there are natural products that could be further developed to provide a complete cure for many diseases, including viruses, killer viruses, cancers, and even heart disease. The problem is that because these products are natural, they are not readily patentable, and not being readily patentable, nobody will fund the billions of dollars required for research and especially for FDA approval. We must demand that the government change the rules so that the research and approval process no longer costs billions.
There are currently more than one thousand clinical trials listed on the government’s website looking at COVID-19; of those, there are only a small handful of trials assessing the efficacy of natural medicines for COVID-19. Many of these trials are poorly designed, with intravenous vitamin C (IVC) being the perfect example. There are a number of trials looking at IVC for COVID-19, but the doses are generally far too small, well below the doses that have been given to cancer patients (which can be up to 100g infusions, compared to some trials giving just 1.5g). High doses are required to achieve peak blood levels to generate hydrogen peroxide which, even in small amounts, can inactivate coronaviruses. Although reports indicate that these lower doses of IVC help patients get out of intensive care units sooner, there was no proven effect on mortality. To save lives adequate levels of IVC should be properly studied as a COVID-19 treatment. This is just one example among many.
Most promising treatments are not being studied at all and have little chance of attracting the necessary attention and funding with the billion dollar FDA approval process standing in the way. Here are a few key examples of items that have tremendous potential but are being ignored by Pharma and its allies in government:
Potassium appears to be another key nutrient implicated in COVID-19 cases. Preliminary data show that COVID-19 patients exhibit hypokalemia (low potassium in the blood) and that potassium supplementation assisted recovery. Note that a national survey of 16,444 Americans found that 100% were not getting the estimated average requirement (EAR) of potassium (EAR is the intake level for a nutrient at which the needs of 50 percent of the population will be met). This critical nutrient could be saving lives right now, but the government is only focused on pharmaceutical interventions that can make drug companies rich.
appears to be another key nutrient implicated in COVID-19 cases. show that COVID-19 patients exhibit hypokalemia (low potassium in the blood) and that potassium supplementation assisted recovery. Note that a of 16,444 Americans found that 100% were not getting the estimated average requirement (EAR) of potassium (EAR is the intake level for a nutrient at which the needs of 50 percent of the population will be met). This critical nutrient could be saving lives right now, but the government is only focused on pharmaceutical interventions that can make drug companies rich. There is promising initial data regarding zinc , quercetin, and epigallocatechin-gallate (EGCG) . High concentrations of zinc inside cells inhibit the replication of RNA viruses such as COVID-19, but due to zinc’s other characteristics, cells do not typically tolerate high levels of this mineral. Quercetin and EGCG enhance the entry of zinc into cells, much like the drug chloroquine (which when studied in combination with zinc ) proved useful while when studied alone did not). Unlike chloroquine, quercetin and EGCG do not have dangerous or potentially even fatal side-effects. Note too that quercetin itself has anti-viral properties . There have already been animal trials on the zinc/quercetin combination for use against Ebola and SARS-CoV1, and human clinical trials have been approved by the FDA. There is only one small trial in Turkey that is looking at quercetin, but without zinc. Some researchers believe that zinc in general is one of the most important things we can take both to avoid Covid-19 infection and treat it.
, and . High concentrations of zinc inside cells inhibit the replication of RNA viruses such as COVID-19, but due to zinc’s other characteristics, cells do not typically tolerate high levels of this mineral. Quercetin and EGCG the entry of zinc into cells, much like the drug chloroquine (which when in ) proved useful while when studied alone did not). Unlike chloroquine, quercetin and EGCG do not have dangerous or potentially even fatal side-effects. Note too that quercetin itself . There have been animal trials on the zinc/quercetin combination for use against Ebola and SARS-CoV1, and human clinical trials have been approved by the FDA. There is only one that is looking at quercetin, but without zinc. Some researchers believe that zinc in general is one of the we can take both to avoid Covid-19 infection and treat it. Oregano oil and monolaurin are candidates to target the viral capsule of coronaviruses. Monolaurin is being studied in the Philippines, but is ignored by the US government.
and are candidates to target the viral capsule of coronaviruses. Monolaurin is being in the Philippines, but is ignored by the US government. Silver , particularly nebulized silver, also has potential as an anti-viral or to prevent follow up bacterial infections. Crucially, evidence shows that silver hydrosol may be effective against certain strains of coronavirus like SARS. Silver also shows promise against other viruses like HIV and herpes . Meanwhile both the FDA and the FTC are refusing to allow any claims for silver at all.
, particularly nebulized silver, also has potential as an anti-viral or to prevent follow up bacterial infections. Crucially, that silver hydrosol may be effective against certain strains of coronavirus like SARS. Silver also shows promise against other viruses like and . Meanwhile both the FDA and the FTC are refusing to allow any claims for silver at all. Vitamin D is a key immune system regulator. People with especially low D are more vulnerable to Covid-19. Research has also shown that low vitamin D is linked with worse COVID-19 outcomes. Our government should be getting this information out to everyone, but refusing even to discuss it.
These are just a few of the many promising natural therapies suggested by integrative medicine circles for COVID-19 treatment. You can consult our previous articles for more information. Here are some further examples:
Data show that dietary selenium is linked with COVID-19 outcomes: a study found that patients in areas with high levels of selenium were more likely to recover from the virus, while places with lower selenium intake had a death rate five times higher.
found that patients in areas with high levels of selenium were more likely to recover from the virus, while places with lower selenium intake had a death rate five times higher. Many supplements (curcumin, resveratrol, luteolin etc.) are candidates to help control the cytokine storm that may kill Covid-19 patients but are not being tested for this use.
to help control the cytokine storm that may kill Covid-19 patients but are not being tested for this use. Viruses cloak themselves from the immune system using a substance called nagalase . Some supplements, especially probiotics , are candidates to help control nagalase but are also unlikely to be tested for this use.
. Some supplements, , are candidates to help control nagalase but are also unlikely to be tested for this use. Other supplements , like the herb Andrographis paniculate, are candidates to interfere with enzymes needed by the virus to reproduce but are also unlikely ever to be tested for this use.
, like the herb Andrographis paniculate, are to interfere with enzymes needed by the virus to reproduce but are also unlikely ever to be tested for this use. Drugs like proton pump inhibitors can increase the likelihood of serious infection with COVID-19. Shouldn’t millions of users be told?
Our COVID-411 page also has a list of other supplements that may be helpful for prevention or treatment, including melatonin, NAC, beta glucans, garlic, and vitamin A.
Our government now touts a drug, remdesivir, as the new “standard of care,” the mortality rate of which is not statistically different from placebo. Why? Because it is a new drug that can make a fortune for the pharmaceutical manufacturer? None of the natural treatments listed above can be easily patented, so no company can afford to pay for FDA approval. As the economy reels from the escalating costs of this pandemic, how can we continue to focus primarily on expensive drugs and ignore affordable micronutrients that show such promise?
Our government’s response to the COVID-19 pandemic is a case-study in crony capitalist medicine. We need thorough studies on these promising natural treatments to assess their viability for COVID-19, and it must happen now.
We need your help to get this message out far and wide. Sending this article to five people you know would do a tremendous service and help get the government’s attention. Please help us.
Action Alert! Write to Congress and the National Institutes of Health, demanding further study on promising natural treatments for COVID-19. Please send your message immediately.


alliancefornaturalhealth--2020-05-21--Crony Medicine Missing the Mark on Chloroquine

Zinc seems to be the key to the drug ’ s effectiveness , but many trials ignore it .
Why ?
Action Alert !
New reports indicate that President Trump is taking hydroxychloroquine in combination with zinc to protect against the coronavirus .
As we ’ ve written before , research indicates that high concentrations of zinc inside cells inhibit the replication of RNA viruses such as COVID-19 , but due to zinc ’ s other characteristics , cells do not typically tolerate high levels of this mineral .
Further research indicates that hydroxychloroquine helps by getting zinc into the @ @ @ @ @ @ @ President Trump or his physicians understand the importance of zinc , whereas most of the clinical trials on hydroxychloroquine in the US deliberately leave zinc out , presumably because zinc is not a patentable drug .
Moreover , hydroxychloroquine is now off-patent , so it is a cheap drug which will not make large profits for Big Pharma .
Predictably , we ’ ve seen these trials so far find no benefit for hydroxychloroquine alone .
Hydroxychloroquine is a highly toxic drug with potentially negative side effects .
By contrast , quercetin , @ @ @ @ @ @ @ and enhances the entry of zinc into cells .
Note too that quercetin itself has anti-viral properties .
There have already been animal trials on the zinc/quercetin combination for use against Ebola and SARS-CoV1 , and human clinical trials have been approved by the FDA .
EGCG from green tea also may enhance the entry of zinc into cells .
Missing the importance of zinc is yet another example of a crony medical system that largely ignores unpatentable , natural products in preference for expensive pharmaceutical drugs .
In order to make any @ @ @ @ @ @ @ would need to go through FDA drug approval , which is an exorbitantly expensive process .
But because supplements are generally not patentable like drugs are , no company will fund the research necessary to gain FDA approval .
The result is that promising natural treatments like zinc that work are completely ignored by our health system .
Now is the time to educate Congress about this unlevel playing field that throttles natural products .
Action Alert !
Write to the FDA and Congress , telling them to allow nutrient/COVID research by changing @ @ @ @ @ @ @ approval process no longer costs billions .
Please send your message immediately .

Zinc seems to be the key to the drug’s effectiveness, but many trials ignore it. Why? Action Alert!
New reports indicate that President Trump is taking hydroxychloroquine in combination with zinc to protect against the coronavirus. As we’ve written before, research indicates that high concentrations of zinc inside cells inhibit the replication of RNA viruses such as COVID-19, but due to zinc’s other characteristics, cells do not typically tolerate high levels of this mineral. Further research indicates that hydroxychloroquine helps by getting zinc into the cells.
It is interesting that either President Trump or his physicians understand the importance of zinc, whereas most of the clinical trials on hydroxychloroquine in the US deliberately leave zinc out, presumably because zinc is not a patentable drug. Moreover, hydroxychloroquine is now off-patent, so it is a cheap drug which will not make large profits for Big Pharma. Predictably, we’ve seen these trials so far find no benefit for hydroxychloroquine alone.
Hydroxychloroquine is a highly toxic drug with potentially negative side effects. By contrast, quercetin, a natural substance, is completely non-toxic and enhances the entry of zinc into cells. Note too that quercetin itself has anti-viral properties. There have already been animal trials on the zinc/quercetin combination for use against Ebola and SARS-CoV1, and human clinical trials have been approved by the FDA. EGCG from green tea also may enhance the entry of zinc into cells.
Missing the importance of zinc is yet another example of a crony medical system that largely ignores unpatentable, natural products in preference for expensive pharmaceutical drugs. In order to make any kind of health claim, a supplement would need to go through FDA drug approval, which is an exorbitantly expensive process. But because supplements are generally not patentable like drugs are, no company will fund the research necessary to gain FDA approval. The result is that promising natural treatments like zinc that work are completely ignored by our health system.
Now is the time to educate Congress about this unlevel playing field that throttles natural products.
Action Alert! Write to the FDA and Congress, telling them to allow nutrient/COVID research by changing the rules so that the research and approval process no longer costs billions. Please send your message immediately.


alliancefornaturalhealth--2020-05-21--Estriol Ban Still Looming

Estriol Ban Still Looming

Here ’ s why we think a ban is coming .
Action Alert !
A National Academies of Sciences , Engineering , and Medicine ( NASEM ) committee recently released a report regarding compounded pain creams .
The report makes clear that , like the FDA , NASEM does not seem to understand the purpose of pharmacy compounding , which is a dire concern as we await another NASEM report assessing the “ clinical utility ” of compounded bioidentical hormones .
We fear that the upcoming NASEM report will give the FDA cover to ban compounded bioidentical hormones like estriol @ @ @ @ @ @ @ NASEM listen to consumers who rely on these medicines .
The NASEM report ’ s conclusion demonstrates that NASEM , like the FDA , doesn ’ t understand compounding : Please note that what NASEM regards as potentially effective excludes CBD oil and other supplements , not to mention many drugs that have not been formally approved for this use .
The NASEM committee then concluded that the “ lack of evidence regarding systemic absorption of ingredients used in compounded topical pain creams gives rise to a substantial public health concern that requires @ @ @ @ @ @ @ .
Our translation : all topical pain creams should be FDA-approved , which means that the producers must be willing to spend billions of dollars to gain approval , which will in turn mean that only patentable drugs will be available .
The existence of FDA-approved versions of medicines used by compounding pharmacies is not relevant to the need for compounded medications .
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 @ @ @ @ @ @ @ patients with allergies , sensitivities to environmental contaminants and preservatives , or who require doses or delivery systems different than those of commercially available products .
The whole point is that many patients , for a variety of reasons , can not take FDA-approved versions of a medicine , so they need access to different versions of those medicines from compounding pharmacies to stay healthy .
What most concerns us is the fact that the report reads as if it was produced by the FDA , which has demonstrated almost nothing but antipathy @ @ @ @ @ @ @ NASEM is apparently ignorant of the important role compounded medicines play in patient health does not bode well for the review of estriol and other compounded bioidentical hormones .
A NASEM report finding that compounded hormones are unnecessary because there are FDA-approved hormones on the market would give the FDA plenty of cover to issue a ban on these vital medicines .
To briefly recap where we are : estriol and other bioidentical hormones have been nominated to the FDA ’ s Demonstrably Difficult to Compound List ; items that appear on the @ @ @ @ @ @ @ longer be able to be made at compounding pharmacies .
The FDA convened a NASEM committee to study the clinical utility of treating patients with compounded bioidentical hormones ; the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones .
The FDA ’ s hostility to customized bioidentical hormones has nothing to do with safety .
We ’ ve noted that the FDA acknowledged it hadn ’ t received any adverse events pertaining to estriol , which shouldn @ @ @ @ @ @ @ its safety profile is exceptional .
Actually , there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives .
A review of the literature came to the following conclusion : “ Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks , including the risk of breast cancer and cardiovascular disease , and are more efficacious than their synthetic and animal-derived counterparts.
” There is evidence , then , that the FDA is poised to eliminate the safer alternatives in compounded bioidentical hormones : @ @ @ @ @ @ @ product , meaning that an FDA ban on compounded estriol means patients will completely lose access to this critical hormone .
We fear that the committee will not even understand the crucial difference between estriol and other estrogens .
We must continue to speak out to the FDA , telling them that patients rely on these critical medicines .
Action Alert !
Write to the FDA and NASEM , with a copy to Congress , telling them that patients rely on compounded bioidentical hormones like estriol .
Please send your message immediately .

Here’s why we think a ban is coming. Action Alert!
A National Academies of Sciences, Engineering, and Medicine (NASEM) committee recently released a report regarding compounded pain creams. The report makes clear that, like the FDA, NASEM does not seem to understand the purpose of pharmacy compounding, which is a dire concern as we await another NASEM report assessing the “clinical utility” of compounded bioidentical hormones. We fear that the upcoming NASEM report will give the FDA cover to ban compounded bioidentical hormones like estriol. We must make the FDA and NASEM listen to consumers who rely on these medicines.
The NASEM report’s conclusion demonstrates that NASEM, like the FDA, doesn’t understand compounding:
There is limited evidence to support the use of compounded topical pain creams to treat pain conditions in the general adult population. The few APIs [active pharmaceutical ingredients] that show potential effectiveness in compounded topical pain creams…are already available in FDA-approved topical products used to treat pain.
Please note that what NASEM regards as potentially effective excludes CBD oil and other supplements, not to mention many drugs that have not been formally approved for this use.
The NASEM committee then concluded that the “lack of evidence regarding systemic absorption of ingredients used in compounded topical pain creams gives rise to a substantial public health concern that requires “additional oversight” by the government. Our translation: all topical pain creams should be FDA-approved, which means that the producers must be willing to spend billions of dollars to gain approval, which will in turn mean that only patentable drugs will be available.
The existence of FDA-approved versions of medicines used by compounding pharmacies is not relevant to the need for compounded medications. 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 whole point is that many patients, for a variety of reasons, cannot take FDA-approved versions of a medicine, so they need access to different versions of those medicines from compounding pharmacies to stay healthy.
What most concerns us is the fact that the report reads as if it was produced by the FDA, which has demonstrated almost nothing but antipathy towards pharmacy compounding. The fact that NASEM is apparently ignorant of the important role compounded medicines play in patient health does not bode well for the review of estriol and other compounded bioidentical hormones. A NASEM report finding that compounded hormones are unnecessary because there are FDA-approved hormones on the market would give the FDA plenty of cover to issue a ban on these vital medicines.
To briefly recap where we are: estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. The FDA convened a NASEM committee to study the clinical utility of treating patients with compounded bioidentical hormones; the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones.
The FDA’s hostility to customized bioidentical hormones has nothing to do with safety. We’ve noted that the FDA acknowledged it hadn’t received any adverse events pertaining to estriol, which shouldn’t come as any surprise: its safety profile is exceptional.
Actually, there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”
Other researchers have reached similar conclusions:
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer [emphasis added].
There is evidence, then, that the FDA is poised to eliminate the safer alternatives in compounded bioidentical hormones: remember that there is no FDA-approved estriol product, meaning that an FDA ban on compounded estriol means patients will completely lose access to this critical hormone. We fear that the committee will not even understand the crucial difference between estriol and other estrogens. We must continue to speak out to the FDA, telling them that patients rely on these critical medicines.
Action Alert! Write to the FDA and NASEM, with a copy to Congress, telling them that patients rely on compounded bioidentical hormones like estriol. Please send your message immediately.


alliancefornaturalhealth--2020-05-21--May 23rd Is Our Deadline to Protect Homeopathy

We must oppose the FDA ’ s actions against homeopathic medicines now .
Action Alert !
For months now , we ’ ve been telling you about the FDA ’ s latest actions with regard to homeopathic medicines .
These actions upend decades of successful regulation of these important products that have been used safely for centuries .
The wording of the FDA ’ s draft guidance threatens all homeopathic medicines and gives the FDA the ability to go after any homeopathic drug it wants to .
The comment period for this guidance closes on May 23rd .
Concerned citizens @ @ @ @ @ @ @ comment on the guidance , or take action below using ANH ’ s automated system .
As we ’ ve reported previously , the FDA ’ s guidance says : • Any homeopathic drug that has not been considered “ generally recognized as safe and effective ” ( GRAS/E ) is considered a new drug ; • FDA has not determined that any homeopathic drugs are GRAS/E ; • A new drug can not be marketed unless it goes through the FDA ’ s approval process ; • No homeopathic drugs have gone @ @ @ @ @ @ @ afford to take them through the approval process since homeopathic medicines have been in use for centuries and generally can not be patented .
This means , according to the FDA , all homeopathic medicines are being marketed illegally .
The FDA explains that it will focus enforcement actions against specific categories of medicines with safety concerns : products with dangerous ingredients , products intended for vulnerable populations , etc .
However , the FDA does reserve the right to take action against any homeopathic product : “ This guidance is intended to @ @ @ @ @ @ @ that is being marketed illegally is subject to FDA enforcement action at any time.
” There is not much new in the revised guidance .
The FDA does provide a definition of “ homeopathic drug , ” which was notably absent from the initial guidance , much to the confusion of the homeopathic industry and other stakeholders .
It is somewhat encouraging that the agency did not issue a final guidance , but rather another draft .
This is an indication that our voices are being heard and the FDA is worried about @ @ @ @ @ @ @ members of the natural health community .
There seems to be a lot of confusion about homeopathy .
While opponents often say that there is not any evidence that homeopathy works , several major meta-analyses have found homeopathic medicines to have an effect greater than placebo .
We address these and some other common misconceptions here .
Unfortunately , it ’ s likely that the FDA ’ s antipathy towards homeopathy is fueled more by a desire to protect drug industry profits than ignorance about the data .
The FDA continues to cite @ @ @ @ @ @ @ of the concerns that prompted the agency to tighten control over homeopathic medicines .
Specifically , the agency states that 99 adverse events were “ possibly related ” to homeopathic teething products .
Yet , while the agency did find variable amounts of belladonna in some products , these amounts were well within safe limits , even if an infant swallowed an entire bottle .
Homeopathic medicines compete on the same unlevel playing field as supplements against pharmaceutical drugs .
Because homeopathic medicines generally can not be patented , no company can afford @ @ @ @ @ @ @ that homeopathic drugs can not make disease claims .
This deprives consumers of information about medicines that could help them stay healthy .
The FDA will not stop this attack on homeopathy unless it is forced to do so by engaged citizens .
We must issue a strong response to the FDA and Congress , telling the government that these actions threaten the future of homeopathic medicine .
Action Alert !
Go to Regulations.gov and leave a comment telling the FDA to protect homeopathy !
You can also hit the button below to @ @ @ @ @ @ @ FDA .
Please send your message immediately .

We must oppose the FDA’s actions against homeopathic medicines now. Action Alert!
For months now, we’ve been telling you about the FDA’s latest actions with regard to homeopathic medicines. These actions upend decades of successful regulation of these important products that have been used safely for centuries. The wording of the FDA’s draft guidance threatens all homeopathic medicines and gives the FDA the ability to go after any homeopathic drug it wants to. The comment period for this guidance closes on May 23rd. Concerned citizens can go here to leave their own comment on the guidance, or take action below using ANH’s automated system.
As we’ve reported previously, the FDA’s guidance says:
Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug; FDA has not determined that any homeopathic drugs are GRAS/E; A new drug cannot be marketed unless it goes through the FDA’s approval process; No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process since homeopathic medicines have been in use for centuries and generally cannot be patented.
This means, according to the FDA, all homeopathic medicines are being marketed illegally. The FDA explains that it will focus enforcement actions against specific categories of medicines with safety concerns: products with dangerous ingredients, products intended for vulnerable populations, etc. However, the FDA does reserve the right to take action against any homeopathic product: “This guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time.”
There is not much new in the revised guidance. The FDA does provide a definition of “homeopathic drug,” which was notably absent from the initial guidance, much to the confusion of the homeopathic industry and other stakeholders.
It is somewhat encouraging that the agency did not issue a final guidance, but rather another draft. This is an indication that our voices are being heard and the FDA is worried about political push back from voters who are members of the natural health community.
There seems to be a lot of confusion about homeopathy. While opponents often say that there is not any evidence that homeopathy works, several major meta-analyses have found homeopathic medicines to have an effect greater than placebo. We address these and some other common misconceptions here.
Unfortunately, it’s likely that the FDA’s antipathy towards homeopathy is fueled more by a desire to protect drug industry profits than ignorance about the data. The FDA continues to cite homeopathic teething tablets with belladonna as one of the concerns that prompted the agency to tighten control over homeopathic medicines. Specifically, the agency states that 99 adverse events were “possibly related” to homeopathic teething products. Yet, while the agency did find variable amounts of belladonna in some products, these amounts were well within safe limits, even if an infant swallowed an entire bottle.
Homeopathic medicines compete on the same unlevel playing field as supplements against pharmaceutical drugs. Because homeopathic medicines generally cannot be patented, no company can afford the astronomical expense of FDA-approval, meaning that homeopathic drugs cannot make disease claims. This deprives consumers of information about medicines that could help them stay healthy.
The FDA will not stop this attack on homeopathy unless it is forced to do so by engaged citizens. We must issue a strong response to the FDA and Congress, telling the government that these actions threaten the future of homeopathic medicine.
Action Alert! Go to Regulations.gov and leave a comment telling the FDA to protect homeopathy! You can also hit the button below to send a message to Congress and the FDA. Please send your message immediately.


alliancefornaturalhealth--2020-05-28--Doctors Gagged as Feds Launch Censorship Campaign

Your right to learn from your doctor about natural methods of staying healthy during the pandemic are under threat .
We must fight back .
Petition !
The FDA , FTC , Department of Justice , and some state attorneys general have launched a coordinated censorship campaign that prevents medical and naturopathic doctors from communicating their extensive knowledge about how to stay healthy during the pandemic using natural medicine .
The actions of these federal agencies will lead to more COVID-19 infections and death .
We have to fight back to preserve our right to stay healthy , naturally .
@ @ @ @ @ @ @ a hundred warning letters to doctors , clinics , and companies .
These letters all allege that companies or individuals were 1 ) illegally advertising that certain products treat or prevent Coronavirus Disease 2019 ( COVID-19 ) or related conditions , such as inflammation and/or 2 ) making claims on their websites implying that a product could mitigate , prevent , treat , diagnose , or cure COVID-19 or related conditions in people , making the product an unapproved drug under the Food , Drug , and Cosmetic Act .
In reviewing many @ @ @ @ @ @ @ is that this isn ’ t about public health , but rather censoring scientific information about natural products and protecting the profits of drug companies .
One letter was sent to a nutritionist who talked about the results of a recent study showing that the severity of coronavirus patient outcome was tied to the patient ’ s vitamin D status .
The post concluded , “ The bottom line ?
In order to give yourself the best defense against the coronavirus , begin with optimizing your vitamin D status to at least 30 @ @ @ @ @ @ @ now a public health threat that the government must snuff out ?
Does the government really want to quash information that could help us stay healthy ?
Government censors also didn ’ t like when doctors wrote that vitamin D “ has demonstrated efficacy for respiratory health…and has anti-inflammatory properties , ” or when they quote science , such as a scholarly paper that “ argues that melatonin—at low doses like 0.5 or 1 mg per day—might curb virulence of the coronavirus… ” .
The FTC is even flagging claims about the use @ @ @ @ @ @ @ and support immunity .
At issue for many of these letters is the idea that , according to the FTC , it is unlawful to advertise that a product can prevent , treat , or cure human disease unless you possess “ competent and reliable scientific evidence ” to substantiate the claim .
The FTC has interpreted this to mean that you need a randomized controlled trial ( RCT ) , which is an impossible standard because of costs and other reasons for everyone but drug companies .
( This issue was litigated @ @ @ @ @ @ @ POM Wonderful case we covered extensively . )
We believe these kinds of actions are really meant to preserve the drug industry monopoly on medicine .
RCTs are prohibitively expensive , costing billions of dollars on average .
Drug companies can afford this massive investment because drugs are patentable and enjoy a period of market exclusivity , so companies can recoup the cost of RCTs .
Natural products are generally not patentable , so requiring RCTs to make any specific disease claim—no matter how many studies support the claim—is a backhanded way of @ @ @ @ @ @ @ and thus preserving the monopoly of pharmaceutical drugs to treat illness .
So let ’ s get this straight .
The FDA and FTC are telling doctors they can ’ t talk about or advise the public on natural methods of treating or preventing COVID-19 .
These same agencies , particularly the FDA in combination with the CDC , have repeatedly bungled our nation ’ s response to the pandemic .
These same agencies issue emergency approvals for dangerous drugs that go on to kill people .
These same agencies are threatening to @ @ @ @ @ @ @ choose estriol as a treatment .
These same agencies , and the laws they enforce , make our medicine less effective , more expensive , and more dangerous .
And now they want to prevent Americans from learning about scientifically-proven benefits of supplements like vitamin D to help during the pandemic ?
Never before has our crony capitalist government put so many lives at risk so needlessly .
Note too that President Trump himself is not only taking zinc along with hydroxychloroquine .
He is also publicizing it , which is seemingly at @ @ @ @ @ @ @ within his own government .
Various state attorneys general have also gotten in on the action .
This is not just another action alert .
This is a petition .
We are going to be contacting federal and state officials , including the President , to explain how agencies that are supposed to be protecting Americans are , and have been , undermining and endangering our health .
This is a critical moment , and we need as many signatures as possible .
Please take action below and share this with people you @ @ @ @ @ @ @ Trump , telling him to stop the FDA and the FTC from further pursuing this censorship campaign , with copies to Congress and state legislators , telling them to fix the laws that make medicine in this country more expensive , more dangerous , and less effective .
Please send your message immediately .

Your right to learn from your doctor about natural methods of staying healthy during the pandemic are under threat. We must fight back. Petition!
The FDA, FTC, Department of Justice, and some state attorneys general have launched a coordinated censorship campaign that prevents medical doctors and other healthcare providers from communicating their extensive knowledge about how to stay healthy during the pandemic using natural medicine. The actions of these federal agencies will lead to more COVID-19 infections and death. We have to fight back to preserve our right to stay healthy, naturally.
The FDA and FTC sent more than a hundred warning letters to doctors, clinics, and companies. These letters all allege that companies or individuals were 1) illegally advertising that certain products treat or prevent Coronavirus Disease 2019 (COVID-19) or related conditions, such as inflammation and/or 2) making claims on their websites implying that a product could mitigate, prevent, treat, diagnose, or cure COVID-19 or related conditions in people, making the product an unapproved drug under the Food, Drug, and Cosmetic Act.
In reviewing many of these letters, what becomes clear is that this isn’t about public health, but rather censoring scientific information about natural products and protecting the profits of drug companies. One letter was sent to a nutritionist who talked about the results of a recent study showing that the severity of coronavirus patient outcome was tied to the patient’s vitamin D status. The post concluded, “The bottom line? In order to give yourself the best defense against the coronavirus, begin with optimizing your vitamin D status to at least 30 ng/ml starting today.” Is vitamin D now a public health threat that the government must snuff out? Does the government really want to quash information that could help us stay healthy?
Government censors also didn’t like when doctors wrote that vitamin D “has demonstrated efficacy for respiratory health…and has anti-inflammatory properties,” or when they quote science, such as a scholarly paper that “argues that melatonin—at low doses like 0.5 or 1 mg per day—might curb virulence of the coronavirus…”. The FTC is even flagging claims about the use of natural approaches to fight respiratory infections and support immunity.
At issue for many of these letters is the idea that, according to the FTC, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless you possess “competent and reliable scientific evidence” to substantiate the claim. The FTC has interpreted this to mean that you need a randomized controlled trial (RCT), which is an impossible standard because of costs and other reasons for everyone but drug companies. (This issue was litigated a number of years ago in the POM Wonderful case we covered extensively.)
We believe these kinds of actions are really meant to preserve the drug industry monopoly on medicine. RCTs are prohibitively expensive, costing billions of dollars on average. Drug companies can afford this massive investment because drugs are patentable and enjoy a period of market exclusivity, so companies can recoup the cost of RCTs. Natural products are generally not patentable, so requiring RCTs to make any specific disease claim—no matter how many studies support the claim—is a backhanded way of preventing all disease claims for natural products and thus preserving the monopoly of pharmaceutical drugs to treat illness.
So let’s get this straight. The FDA and FTC are telling doctors they can’t talk about or advise the public on natural methods of treating or preventing COVID-19. These same agencies, particularly the FDA in combination with the CDC, have repeatedly bungled our nation’s response to the pandemic. These same agencies issue emergency approvals for dangerous drugs that go on to kill people. These same agencies are threatening to take away women’s rights to choose estriol as a treatment. These same agencies, and the laws they enforce, make our medicine less effective, more expensive, and more dangerous. And now they want to prevent Americans from learning about scientifically-proven benefits of supplements like vitamin D to help during the pandemic? Never before has our crony capitalist government put so many lives at risk so needlessly.
Note too that President Trump himself is not only taking zinc along with hydroxychloroquine. He is also publicizing it, which is seemingly at odds with the position of the agencies within his own government.
Various state attorneys general have also gotten in on the action.
This is not just another action alert. This is a petition. We are going to be contacting federal and state officials, including the President, to explain how agencies that are supposed to be protecting Americans are, and have been, undermining and endangering our health. This is a critical moment, and we need as many signatures as possible. Please take action below and share this with people you know.
Petition! Write to President Trump, telling him to stop the FDA and the FTC from further pursuing this censorship campaign, with copies to Congress and state legislators, telling them to fix the laws that make medicine in this country more expensive, more dangerous, and less effective. Please send your message immediately.


alliancefornaturalhealth--2020-06-11--Acid Blockers Make COVID-19 More Deadly

Acid Blockers Make COVID-19 More Deadly

The FDA has ignored the dangers long enough .
Action Alert !
ANH-USA has submitted a Citizens Petition to the FDA concerning the increased risk of pneumonia that is associated with proton pump inhibitor ( PPI ) medications for acid reflux .
This effect has been documented for a number of years , yet the agency has so far refused to update these drugs ’ label warning to reflect this danger .
This side effect is especially concerning given the current pandemic , which attacks the respiratory system .
It is time to force the FDA ’ s hand .
@ @ @ @ @ @ @ Prevacid are popular brand names ) block the production of stomach acid and are used to treat heartburn and GERD ( gastroesophageal reflux disease ) .
PPIs have been linked with increased risk of pneumonia which is of particular concern with COVID-19 and the respiratory damage that characterizes advanced cases .
The mechanism by which PPIs cause pneumonia is not fully understood , but one theory is that they compromise the stomach ’ s “ acid mantle ” against gastric colonization of bacteria .
Normally , gastric pH is around 2 , which @ @ @ @ @ @ @ ; PPIs increase this pH to above 4 for approximately 24 hours , compromising this natural defense mechanism .
PPIs may also lead to delayed gastric emptying , increased gastric contents , larger bacterial loads , and increased pressure on the lower esophageal sphincter , causing reflux that brings bacteria back up into the respiratory tract and thus increases the likelihood of infection .
Another theory is that PPIs reduce the acidity of the upper digestive tract which results in increased bacterial colonization of the larynx , esophagus , and lungs .
PPIs @ @ @ @ @ @ @ could be linked to reducing immunity and hence increasing pneumonia risk .
This is key .
We ’ re currently living through a viral pandemic that attacks the respiratory system .
Not only do PPIs weaken our immune response overall , they make us more susceptible to a respiratory infection that could put us more at risk for COVID-19 complications .
Important research has found that PPIs shut off acid pumps , not just in the stomach , but in every other cell of the body .
This interferes with the way cells @ @ @ @ @ @ @ results in “ systematically compromised immunity.
” Referring to his research on PPIs and their effect on the lysosomes , one doctor summed it up like this : “ I think we now have a smoking gun , ” referring to the mechanism by which PPIs cause the wide range of negative health effects that have been documented .
There are an estimated 4.9 million cases of pneumonia in the US per year , requiring more than 250,000 hospitalizations and resulting in 50,000 deaths .
The cost of treating pneumonia in the US @ @ @ @ @ @ @ .
PPIs could be costing us billions of dollars a year in healthcare costs for pneumonia alone , not to mention the other health hazards they cause .
The COVID-19 pandemic starkly underlines the significance of these dangers .
The millions of users of PPIs must be warned that using these drugs compromises immunity and increases risk of pneumonia—pertinent information , to say the least , during a viral pandemic that attacks the respiratory system .
Public health experts say between 60 and 70 % of people who take these drugs don ’ @ @ @ @ @ @ @ PPIs do not address the root cause of stomach trouble , which is often too little stomach acid , not too much .
This means that in many cases , taking acid blockers simply makes your stomach problems even worse .
Then there are the other side effects , which we ’ ve written about extensively .
Acid blockers : • Increase the risk of a baby developing asthma if taken by pregnant mothers .
• Increase the risk of bacterial infection and bone fracture .
• Cause both acute and chronic kidney @ @ @ @ @ @ @ dementia by as much as 52 % .
• Raise the risk of heart attack by as much as 20 % .
The FDA already has issued a number of warnings regarding PPIs , including the increased risk of bone fracture , hypomagnesemia ( low serum magnesium levels ) , and Clostridium difficile associated diarrhea .
It ’ s time to add pneumonia to this list , especially given the increased danger as we weather this pandemic .
Action Alert !
Write to the FDA , with a copy to Congress , telling @ @ @ @ @ @ @ PPIs increase risk of pneumonia .
Please send your message immediately .

The FDA has ignored the dangers long enough. Action Alert!
ANH-USA has submitted a Citizens Petition to the FDA concerning the increased risk of pneumonia that is associated with proton pump inhibitor (PPI) medications for acid reflux. This effect has been documented for a number of years, yet the agency has so far refused to update these drugs’ label warning to reflect this danger. This side effect is especially concerning given the current pandemic, which attacks the respiratory system. It is time to force the FDA’s hand.
These widely prescribed drugs (Prilosec and Prevacid are popular brand names) block the production of stomach acid and are used to treat heartburn and GERD (gastroesophageal reflux disease). PPIs have been linked with increased risk of pneumonia which is of particular concern with COVID-19 and the respiratory damage that characterizes advanced cases.
The mechanism by which PPIs cause pneumonia is not fully understood, but one theory is that they compromise the stomach’s “acid mantle” against gastric colonization of bacteria. Normally, gastric pH is around 2, which effectively limits bacterial colonization from ingested microbes; PPIs increase this pH to above 4 for approximately 24 hours, compromising this natural defense mechanism. PPIs may also lead to delayed gastric emptying, increased gastric contents, larger bacterial loads, and increased pressure on the lower esophageal sphincter, causing reflux that brings bacteria back up into the respiratory tract and thus increases the likelihood of infection. Another theory is that PPIs reduce the acidity of the upper digestive tract which results in increased bacterial colonization of the larynx, esophagus, and lungs.
PPIs also impact the gastrointestinal microbiota, which could be linked to reducing immunity and hence increasing pneumonia risk. This is key. We’re currently living through a viral pandemic that attacks the respiratory system. Not only do PPIs weaken our immune response overall, they make us more susceptible to a respiratory infection that could put us more at risk for COVID-19 complications.
Important research has found that PPIs shut off acid pumps, not just in the stomach, but in every other cell of the body. This interferes with the way cells make energy and detoxify. It also results in “systematically compromised immunity.” Referring to his research on PPIs and their effect on the lysosomes, one doctor summed it up like this: “I think we now have a smoking gun,” referring to the mechanism by which PPIs cause the wide range of negative health effects that have been documented.
There are an estimated 4.9 million cases of pneumonia in the US per year, requiring more than 250,000 hospitalizations and resulting in 50,000 deaths. The cost of treating pneumonia in the US is estimated to be $13.4 billion. PPIs could be costing us billions of dollars a year in healthcare costs for pneumonia alone, not to mention the other health hazards they cause.
The COVID-19 pandemic starkly underlines the significance of these dangers. The millions of users of PPIs must be warned that using these drugs compromises immunity and increases risk of pneumonia—pertinent information, to say the least, during a viral pandemic that attacks the respiratory system.
Public health experts say between 60 and 70% of people who take these drugs don’t need them. Acid blockers like PPIs do not address the root cause of stomach trouble, which is often too little stomach acid, not too much. This means that in many cases, taking acid blockers simply makes your stomach problems even worse.
Then there are the other side effects, which we’ve written about extensively. Acid blockers:
Increase the risk of a baby developing asthma if taken by pregnant mothers.
if taken by pregnant mothers. Increase the risk of bacterial infection and bone fracture.
Cause both acute and chronic kidney disease.
Increase the risk of dementia by as much as 52%.
Raise the risk of heart attack by as much as 20%.
The FDA already has issued a number of warnings regarding PPIs, including the increased risk of bone fracture, hypomagnesemia (low serum magnesium levels), and Clostridium difficile associated diarrhea. It’s time to add pneumonia to this list, especially given the increased danger as we weather this pandemic.
Action Alert! Write to the FDA, with a copy to Congress, telling the agency to add a warning that PPIs increase risk of pneumonia. Please send your message immediately.


alliancefornaturalhealth--2020-06-11--FDA Moves to Eliminate Custom Medicine

FDA Moves to Eliminate Custom Medicine

This rule will make it harder for you to get the customized medications you need .
Action Alert !
As part of its effort to implement the Drug Quality and Security Act of 2013 , the FDA has taken the next step to implement a bad policy that will limit the amount of medicines like bioidentical hormones compounding pharmacies can send out of state , even when patients have a doctor ’ s prescription .
This policy makes it harder for patients to get the medicines they need .
Last month , the FDA made available the final memorandum of @ @ @ @ @ @ @ the interstate distribution of compounded drugs .
It is largely unchanged from the last iteration of the MOU that was released late last year .
This rule concerns how much medicine traditional compounding pharmacies can send out-of-state .
These sales are limited to 5 % unless a state enters into an MOU permitting additional sales .
In exchange , however , the state assumes some of the responsibility for overseeing pharmacies within their borders that send a certain amount of medicine to other states .
Previously , pharmacies in states that signed the @ @ @ @ @ @ @ sales interstate , but the FDA has increased that number to 50 % .
In an earlier proposal in 1999 , the number was 20 % .
It is good that the number has increased , but these changes also highlight the arbitrary nature of this process .
Why not 60 % , or 80 % ?
Why set any limit ?
Does the FDA know what it ’ s doing at all ?
Importantly , the final MOU does not address a key issue , which is that it shouldn ’ t @ @ @ @ @ @ @ for which there is a doctor ’ s prescription at all ; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions .
Why does this distinction matter ?
Limiting the interstate shipment of compounded medicines pursuant to a doctor ’ s prescription will prevent patients from getting the medicines they need .
Certain pharmacies specialize in specific areas , such as bioidentical hormones .
If you get your estriol from a pharmacy in Michigan , and you live in @ @ @ @ @ @ @ real risk that you will no longer be able to get that medicine , even if you ’ ve taken it for years .
If that pharmacy has already sent 50 % of their sales out-of-state , you ’ d be out of luck .
The same goes for any number of crucial medicines for vulnerable populations .
One of the main purposes of compounded medicine is so that patients with allergies , patients who have difficulty swallowing pills , patients who require specialized formulations not available elsewhere , such as autistic children @ @ @ @ @ @ @ to the dietary ingredients and medicines available in the market can get the individualized treatments they need .
An FDA-approved product may have peanut oil in it , so patients could go to a compounding pharmacy to get a peanut-free medicine .
Limiting out-of-state sales for these pharmacies severely limits the options for patients who already have limited options .
Remember , too , that the 50 % limit will only apply in states that actually sign the MOU—otherwise the 5 % limit applies .
Early indications are that many states will not @ @ @ @ @ @ @ submitted to the FDA , the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form , meaning that if the MOU is not revised , almost half the country will be subjected to the FDA ’ s draconian 5 % interstate shipment limit .
All of this is happening simultaneously while the FDA threatens to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone .
These and other hormones have been nominated to the @ @ @ @ @ @ @ List ” ; items that appear on the final list will not be able to be compounded at all .
You can read our previous coverage for more details .
As we ’ ve said all along , it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits , and Big Pharma funds the FDA .
We have to fight back and ensure that patients can get the medicines they need .
Action Alert !
Write to FDA with a copy @ @ @ @ @ @ @ Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor ’ s prescription .
Please send your message immediately .

This rule will make it harder for you to get the customized medications you need. Action Alert!
As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA has taken the next step to implement a bad policy that will limit the amount of medicines like bioidentical hormones compounding pharmacies can send out of state, even when patients have a doctor’s prescription. This policy makes it harder for patients to get the medicines they need.
Last month, the FDA made available the final memorandum of understanding (MOU) with states regarding the interstate distribution of compounded drugs. It is largely unchanged from the last iteration of the MOU that was released late last year.
This rule concerns how much medicine traditional compounding pharmacies can send out-of-state. These sales are limited to 5% unless a state enters into an MOU permitting additional sales. In exchange, however, the state assumes some of the responsibility for overseeing pharmacies within their borders that send a certain amount of medicine to other states.
Previously, pharmacies in states that signed the MOU could send 30% of their sales interstate, but the FDA has increased that number to 50%. In an earlier proposal in 1999, the number was 20%. It is good that the number has increased, but these changes also highlight the arbitrary nature of this process. Why not 60%, or 80%? Why set any limit? Does the FDA know what it’s doing at all?
Importantly, the final MOU does not address a key issue, which is that it shouldn’t be limiting the interstate shipment of medicines for which there is a doctor’s prescription at all; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions.
Why does this distinction matter? Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need. Certain pharmacies specialize in specific areas, such as bioidentical hormones. If you get your estriol from a pharmacy in Michigan, and you live in New Jersey, there’s a real risk that you will no longer be able to get that medicine, even if you’ve taken it for years. If that pharmacy has already sent 50% of their sales out-of-state, you’d be out of luck.
The same goes for any number of crucial medicines for vulnerable populations. One of the main purposes of compounded medicine is so that patients with allergies, patients who have difficulty swallowing pills, patients who require specialized formulations not available elsewhere, such as autistic children, or patients who require other modifications to the dietary ingredients and medicines available in the market can get the individualized treatments they need. An FDA-approved product may have peanut oil in it, so patients could go to a compounding pharmacy to get a peanut-free medicine. Limiting out-of-state sales for these pharmacies severely limits the options for patients who already have limited options.
Remember, too, that the 50% limit will only apply in states that actually sign the MOU—otherwise the 5% limit applies. Early indications are that many states will not sign the MOU. In a comment submitted to the FDA, the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form, meaning that if the MOU is not revised, almost half the country will be subjected to the FDA’s draconian 5% interstate shipment limit.
All of this is happening simultaneously while the FDA threatens to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone. These and other hormones have been nominated to the agency’s “Difficult to Compound List”; items that appear on the final list will not be able to be compounded at all. You can read our previous coverage for more details.
As we’ve said all along, it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits, and Big Pharma funds the FDA. We have to fight back and ensure that patients can get the medicines they need.
Action Alert! Write to FDA with a copy to Congress, telling them to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please send your message immediately.