Conflicts of Interest Mar FDA Pharmacy Committee

Individualized and natural medications are under threat. Action Alert!

Millions of Americans rely on customized medicines made at compounding pharmacies, including bioidentical hormones like estriol. That access is threatened by an FDA advisory committee that is rife with conflicts of interest, including the pharmaceutical industry, which competes with compounding pharmacies.

For years now, we’ve been reporting on the FDA’s Pharmacy Compounding Advisory Committee (PCAC). The committee plays an important role in advising the FDA on implementation of the Drug Quality and Security Act of 2013 (DQSA). Thus far PCAC’s main role has been to make recommendations regarding which substances should or should not be included on the Bulk Drug List as well as the Difficult to Compound list. When finalized, these lists will dictate which medicines can continue to be made at compounding pharmacies—specialized pharmacies that make customized, oftentimes natural medications to meet the needs of individual patients.

Unfortunately, the track record so far has been abysmal, with PCAC routinely following the FDA’s lead and voting to exclude almost every natural medicine with which they’re presented.

A big part of the problem is PCAC’s composition. As we’ve pointed out before, the committee is a stacked deck against pharmacy compounding. Only one member of the committee is a compounder, and he cannot vote. Of the remaining eleven PCAC members, four are academics, three are government officials (one from FDA and two from the National Institutes of Health), and three are non-profit representatives.

Of particular concern is Pew Charitable Trusts’ representation on the committee. Pew presents itself as “an independent, nonpartisan research and public policy organization with a longstanding focus on drug quality issues, including pharmaceutical compounding.” Upon closer examination, though, it seems to us that Pew isn’t so “independent” and may have aligned itself with the pharmaceutical industry.

On June 12, 2017, Pew signed a letter with PhRMA, the trade association for the drug industry, directed to the House Appropriations Committee Chairs and Ranking Members. The letter advocated positions that would financially benefit drug companies, encouraging tighter regulation of compounding pharmacies—which of course make medicines that compete with pharmaceutical drugs.

Then in September 2017 Pew sponsored a Congressional Briefing in partnership with Biotechnology Innovation Organization (BIO), another trade group boasting the biggest names in the pharmaceutical industry. Once again the message was to restrict consumer access to compounded medications, a position that would financially benefit members of BIO.

Pew holds a voting seat on PCAC, but we believe it has a conflict of interest as it partners with pharmaceutical interests on public facing efforts to restrict patient access to compounded medications. Two members of PCAC represent the pharmaceutical industry and compounding pharmacy. Both are non-voting members, in order to mitigate potential conflicts of interest. We don’t believe Pew should hold a voting position on PCAC when it advocates in partnership with pharmaceutical companies and takes positions that could greatly benefit these private entities.

PCAC should be comprised of voting members with an expertise on compounding who can form objective opinions. The rules governing the compounding industry, which is so crucial to millions of Americans, should not be set by competing companies—and their allies—who would benefit if the industry was regulated out of existence. We believe Pew should be replaced with an organization that can fulfill this important function.

Action Alert! Write to the FDA and Congress, telling them that Pew must be removed from PCAC due to conflicts of interest. Please send your message immediately.

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Will Your State Block Access to Natural Healthcare Choices or Supplements?

New bills introduced throughout the US. Will you and your family be affected?  State-based action alerts!

It’s the beginning of many states’ legislative sessions, and there are a number of bills being considered that could affect your access to naturopaths, nutritionists, and supplements, as well as vaccine choice. Check below to see if your state is one of them, and click the link to take action!

Dietetics

ANH believes that the market for nutrition services should be open and transparent, where consumers can decide for themselves the level of education and experience, and the kind of training they prefer in a nutrition professional. Too often, particular trade associations, such as the Academy of Nutrition and Dietetics (AND), the trade association for Registered Dieticians, try to exclude other professionals from practicing and instead create a monopoly for one particular type of professional. In practice this often means that practitioners who don’t ascribe to a narrow set of conventional practices are unable to compete. ANH supports state bills that allow nutrition professionals to practice to the full extent of their knowledge and training. Click on your state to take action below.

Oppose:

New York SB 2231 provides for licensure of dieticians and nutritionists but does not allow unlicensed practitioners to practice “medical nutrition therapy”—meaning that unlicensed individuals could not provide consumers with information related to specific conditions, which we believe is overly restrictive and does not allow all professionals to practice to the full extent of their education and training.

Florida SB 758/HB 561 restricts who can provide diabetes self-management training to someone who is registered and is a certified diabetes educator from the American Association of Diabetes Educators (AADE). This unfairly restricts the market for diabetes education to those certified to the AADE. Patients should be afforded the choice to seek advice from the practitioner best suited to help them, and not have their choices arbitrarily limited by the state government. It is also not the government’s role to deliver business to the AADE, and help them win a monopoly over the diabetes education field.

Support:

Florida HB 1047 opens up the practice of nutrition in the state. The bill allows health coaches, holistic professionals, nutritional therapy practitioners, and others to provide nutrition services, advice, and recommendations without needing a license.

Naturopathic Licensure

ANH believes that naturopathic doctors (NDs) who have been educated at accredited naturopathic, four-year medical schools should be able to practice medicine consistent with that training. This involves a licensure program that provides a scope of practice similar to a conventional medical doctor, keeping in mind that NDs expertise is in natural approaches to health and healing. However, an ANH-supported licensure law for NDs would not exclude traditional naturopaths – those trained by other institutions – from practicing. Although they would not have the same scope as naturopathic doctors, they would be free to continue their current practices. ANH believes that natural health practitioners should be able to practice to the full extent of their training and experience, and consumers—not the government—should decide which credentials they prefer when seeking natural health services.

Support:

Pennsylvania SB 834 sets up a licensure program for naturopathic doctors and defines their scope of practice, while still allowing traditional naturopaths to continue to practice.

Minnesota HB 1138/SB 1514 sets up a licensure program for naturopathic doctors and defines their scope of practice, while still allowing traditional naturopaths to continue to practice.

Supplements

Supplements are a key component of natural medicine. ANH defends consumer access to quality dietary supplements and opposes state efforts to restrict consumer access.

Oppose:

Massachusetts HB 1195 would force retailers to place supplements marketed for weight-loss and muscle-building behind sales counters, accessible only by store managers or pharmacists, and available only to those who are 18 years of age and older.  The major problem with this bill is that we just don’t know how many supplements will fall under its loosely defined categories. Will your protein powder suddenly become over the counter? Or consider weight-loss supplements: will they include natural laxatives? This law will force people into the embarrassing situation of having to announce needing a laxative for a health condition they have—some might even stop buying products they need to avoid this embarrassment. Will probiotics be considered “weight-loss” supplements? We just don’t know, which is why this bill must be opposed.

Vaccines

Many states will be considering bills that limit vaccine choice, whether by eliminating or restricting exemptions or mandating vaccines for children or certain workers. Patients deserve a right to decide which medical treatments to receive, especially when there are safety concerns. There is plenty of scientific data that throws the safety of vaccine ingredients into serious question.

Florida: S 1558/HB 1343 adds HPV to the list of vaccines required for school.

Hawaii: HB 779 would establish a philosophical belief exemption to vaccination.

Iowa: HF 261 and SF 116 would restrict or eliminate the religious belief exemption for parents who don’t want their children to be vaccinated. Support HF 7, which would add a personal exemption to vaccination.

Illinois: SB 741 and HB 2984 would require healthcare workers to get the flu shot and allow any facility licensed by the health dept. to mandate flu vaccines for health care personnel, respectively.

Kansas: HB 2205 would mandate the meningitis vaccine for school children.

Maine: LD 1664 and LD 272/HP 205 mandate the meningitis vaccine for school children.

MN: HF 2379/SF 1994 and SF 1129/HF 2469 would allow minors to consent to HPV vaccination.

Minnesota: SB 760 requires flu vaccines for healthcare workers. SB 741 creates a new law that no mercury-containing vaccines can be administered to children; and HB 1560 prohibits discrimination against unvaccinated children. 

Mississippi: SB 2059, HB 47, and HB 414 would establish religious and philosophical belief exemptions to vaccination, allow adults to deny vaccines, and prohibit Hep B vaccination at birth unless parents request it.

New Hampshire: HB 1503 would allow minors to consent to all medical procedures, including vaccination.

New Jersey: S941, A1847, and A3968/S2332 mandate the meningitis vaccine for college students, the HPV vaccine for sixth through twelfth graders, and mandate vaccines for healthcare workers.

New York: S52/A1810, S3546, A2469, A1230, A933, A738, and S132 would eliminate or restrict the religious belief exemption for parents who don’t want their children to be vaccinated, mandate certain vaccines, including the incredibly dangerous HPV vaccine, and allow health care workers to administer the HPV/Hep B vaccine to minors without parental consent. S163 strengthens and expands the medical exemption to vaccination.

Oklahoma: SB 1123 would eliminate all exemptions to vaccines except for an extremely restrictive medical exemption. There is also a resolution SJR 57, that would put a question on the next general election ballot about eliminating all non-medical exemptions to vaccines.

Oregon: HB 4157 would mandate the meningitis vaccine for school children.

Pennsylvania: SB 217 would eliminate the conscientious belief exemption, making it more difficult for concerned parents to protect their children.

Rhode Island: H5681 would eliminate the religious belief exemption for parents who don’t want their children to be vaccinated. SB 47 adds a personal belief exemption to vaccines, and H5986 adds a personal belief and philosophical exemption.

Virginia: HB 664 would mandate the meningitis vaccine for school children.

West Virginia: SB 318 would require all healthcare workers to get the flu shot every year. HB 2945 and SB 330 would establish religious and conscientious belief exemptions to vaccination.

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USDA Forgives and Forgets: Fraudulent Organics Certifier to be Reinstated

Organic certifier, banned in EU and Canada, to be reinstated by US. Action Alert!

Sources at the US Department of Agriculture (USDA) have told us that they are planning to recertify ETKO, a Turkish-based organic certifier. As we’ve reported previously, ETKO has been singled out by some countries, notably Canada and the European Union, for its fraudulent certifications. These countries have “decertified” the organization—meaning that they no longer accept ETKO-certified products as organic.

The USDA has had problems with ETKO as far back as 2009, but instead of decertifying this company, it actually reached a settlement agreement with them in 2016. The firm has been under audit by USDA for about a year.

Millions of pounds of fake organic products from overseas have been flooding US markets and threatening domestic producers who follow the rules. One would think that the USDA’s organic program would take the matter seriously and protect consumers from fraud. The agency’s dealings with ETKO, however, paint a different picture.

It’s time for the USDA to protect consumers, domestic farmers, and the integrity of the organic seal by holding fraudulent certifiers accountable.

Action Alert! Write to the USDA and tell them NOT to recertify ETKO. Please send your message immediately.

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Conflicts of Interest Mar FDA Pharmacy Committee

Individualized and natural medications are under threat. Action Alert!

Millions of Americans rely on customized medicines made at compounding pharmacies, including bioidentical hormones like estriol. That access is threatened by an FDA advisory committee that is rife with conflicts of interest, including the pharmaceutical industry, which competes with compounding pharmacies.

For years now, we’ve been reporting on the FDA’s Pharmacy Compounding Advisory Committee (PCAC). The committee plays an important role in advising the FDA on implementation of the Drug Quality and Security Act of 2013 (DQSA). Thus far PCAC’s main role has been to make recommendations regarding which substances should or should not be included on the Bulk Drug List as well as the Difficult to Compound list. When finalized, these lists will dictate which medicines can continue to be made at compounding pharmacies—specialized pharmacies that make customized, oftentimes natural medications to meet the needs of individual patients.

Unfortunately, the track record so far has been abysmal, with PCAC routinely following the FDA’s lead and voting to exclude almost every natural medicine with which they’re presented.

A big part of the problem is PCAC’s composition. As we’ve pointed out before, the committee is a stacked deck against pharmacy compounding. Only one member of the committee is a compounder, and he cannot vote. Of the remaining eleven PCAC members, four are academics, three are government officials (one from FDA and two from the National Institutes of Health), and three are non-profit representatives.

Of particular concern is Pew Charitable Trusts’ representation on the committee. Pew presents itself as “an independent, nonpartisan research and public policy organization with a longstanding focus on drug quality issues, including pharmaceutical compounding.” Upon closer examination, though, it seems to us that Pew isn’t so “independent” and may have aligned itself with the pharmaceutical industry.

On June 12, 2017, Pew signed a letter with PhRMA, the trade association for the drug industry, directed to the House Appropriations Committee Chairs and Ranking Members. The letter advocated positions that would financially benefit drug companies, encouraging tighter regulation of compounding pharmacies—which of course make medicines that compete with pharmaceutical drugs.

Then in September 2017 Pew sponsored a Congressional Briefing in partnership with Biotechnology Innovation Organization (BIO), another trade group boasting the biggest names in the pharmaceutical industry. Once again the message was to restrict consumer access to compounded medications, a position that would financially benefit members of BIO.

Pew holds a voting seat on PCAC, but we believe it has a conflict of interest as it partners with pharmaceutical interests on public facing efforts to restrict patient access to compounded medications. Two members of PCAC represent the pharmaceutical industry and compounding pharmacy. Both are non-voting members, in order to mitigate potential conflicts of interest. We don’t believe Pew should hold a voting position on PCAC when it advocates in partnership with pharmaceutical companies and takes positions that could greatly benefit these private entities.

PCAC should be comprised of voting members with an expertise on compounding who can form objective opinions. The rules governing the compounding industry, which is so crucial to millions of Americans, should not be set by competing companies—and their allies—who would benefit if the industry was regulated out of existence. We believe Pew should be replaced with an organization that can fulfill this important function.

Action Alert! Write to the FDA and Congress, telling them that Pew must be removed from PCAC due to conflicts of interest. Please send your message immediately.

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Will Your State Block Access to Natural Healthcare Choices or Supplements?

New bills introduced throughout the US. Will you and your family be affected?  State-based action alerts!

It’s the beginning of many states’ legislative sessions, and there are a number of bills being considered that could affect your access to naturopaths, nutritionists, and supplements, as well as vaccine choice. Check below to see if your state is one of them, and click the link to take action!

Dietetics

ANH believes that the market for nutrition services should be open and transparent, where consumers can decide for themselves the level of education and experience, and the kind of training they prefer in a nutrition professional. Too often, particular trade associations, such as the Academy of Nutrition and Dietetics (AND), the trade association for Registered Dieticians, try to exclude other professionals from practicing and instead create a monopoly for one particular type of professional. In practice this often means that practitioners who don’t ascribe to a narrow set of conventional practices are unable to compete. ANH supports state bills that allow nutrition professionals to practice to the full extent of their knowledge and training. Click on your state to take action below.

Oppose:

New York SB 2231 provides for licensure of dieticians and nutritionists but does not allow unlicensed practitioners to practice “medical nutrition therapy”—meaning that unlicensed individuals could not provide consumers with information related to specific conditions, which we believe is overly restrictive and does not allow all professionals to practice to the full extent of their education and training.

Florida SB 758/HB 561 restricts who can provide diabetes self-management training to someone who is registered and is a certified diabetes educator from the American Association of Diabetes Educators (AADE). This unfairly restricts the market for diabetes education to those certified to the AADE. Patients should be afforded the choice to seek advice from the practitioner best suited to help them, and not have their choices arbitrarily limited by the state government. It is also not the government’s role to deliver business to the AADE, and help them win a monopoly over the diabetes education field.

Support:

Florida HB 1047 opens up the practice of nutrition in the state. The bill allows health coaches, holistic professionals, nutritional therapy practitioners, and others to provide nutrition services, advice, and recommendations without needing a license.

Naturopathic Licensure

ANH believes that naturopathic doctors (NDs) who have been educated at accredited naturopathic, four-year medical schools should be able to practice medicine consistent with that training. This involves a licensure program that provides a scope of practice similar to a conventional medical doctor, keeping in mind that NDs expertise is in natural approaches to health and healing. However, an ANH-supported licensure law for NDs would not exclude traditional naturopaths – those trained by other institutions – from practicing. Although they would not have the same scope as naturopathic doctors, they would be free to continue their current practices. ANH believes that natural health practitioners should be able to practice to the full extent of their training and experience, and consumers—not the government—should decide which credentials they prefer when seeking natural health services.

Support:

Pennsylvania SB 834 sets up a licensure program for naturopathic doctors and defines their scope of practice, while still allowing traditional naturopaths to continue to practice.

Minnesota HB 1138/SB 1514 sets up a licensure program for naturopathic doctors and defines their scope of practice, while still allowing traditional naturopaths to continue to practice.

Supplements

Supplements are a key component of natural medicine. ANH defends consumer access to quality dietary supplements and opposes state efforts to restrict consumer access.

Oppose:

Massachusetts HB 1195 would force retailers to place supplements marketed for weight-loss and muscle-building behind sales counters, accessible only by store managers or pharmacists, and available only to those who are 18 years of age and older.  The major problem with this bill is that we just don’t know how many supplements will fall under its loosely defined categories. Will your protein powder suddenly become over the counter? Or consider weight-loss supplements: will they include natural laxatives? This law will force people into the embarrassing situation of having to announce needing a laxative for a health condition they have—some might even stop buying products they need to avoid this embarrassment. Will probiotics be considered “weight-loss” supplements? We just don’t know, which is why this bill must be opposed.

Vaccines

Many states will be considering bills that limit vaccine choice, whether by eliminating or restricting exemptions or mandating vaccines for children or certain workers. Patients deserve a right to decide which medical treatments to receive, especially when there are safety concerns. There is plenty of scientific data that throws the safety of vaccine ingredients into serious question.

Florida: S 1558/HB 1343 adds HPV to the list of vaccines required for school.

Hawaii: HB 779 would establish a philosophical belief exemption to vaccination.

Iowa: HF 261 and SF 116 would restrict or eliminate the religious belief exemption for parents who don’t want their children to be vaccinated. Support HF 7, which would add a personal exemption to vaccination.

Illinois: SB 741 and HB 2984 would require healthcare workers to get the flu shot and allow any facility licensed by the health dept. to mandate flu vaccines for health care personnel, respectively.

Kansas: HB 2205 would mandate the meningitis vaccine for school children.

Maine: LD 1664 and LD 272/HP 205 mandate the meningitis vaccine for school children.

MN: HF 2379/SF 1994 and SF 1129/HF 2469 would allow minors to consent to HPV vaccination.

Minnesota: SB 760 requires flu vaccines for healthcare workers. SB 741 creates a new law that no mercury-containing vaccines can be administered to children; and HB 1560 prohibits discrimination against unvaccinated children. 

Mississippi: SB 2059, HB 47, and HB 414 would establish religious and philosophical belief exemptions to vaccination, allow adults to deny vaccines, and prohibit Hep B vaccination at birth unless parents request it.

New Hampshire: HB 1503 would allow minors to consent to all medical procedures, including vaccination.

New Jersey: S941, A1847, and A3968/S2332 mandate the meningitis vaccine for college students, the HPV vaccine for sixth through twelfth graders, and mandate vaccines for healthcare workers.

New York: S52/A1810, S3546, A2469, A1230, A933, A738, and S132 would eliminate or restrict the religious belief exemption for parents who don’t want their children to be vaccinated, mandate certain vaccines, including the incredibly dangerous HPV vaccine, and allow health care workers to administer the HPV/Hep B vaccine to minors without parental consent. S163 strengthens and expands the medical exemption to vaccination.

Oklahoma: SB 1123 would eliminate all exemptions to vaccines except for an extremely restrictive medical exemption. There is also a resolution SJR 57, that would put a question on the next general election ballot about eliminating all non-medical exemptions to vaccines.

Oregon: HB 4157 would mandate the meningitis vaccine for school children.

Pennsylvania: SB 217 would eliminate the conscientious belief exemption, making it more difficult for concerned parents to protect their children.

Rhode Island: H5681 would eliminate the religious belief exemption for parents who don’t want their children to be vaccinated. SB 47 adds a personal belief exemption to vaccines, and H5986 adds a personal belief and philosophical exemption.

Virginia: HB 664 would mandate the meningitis vaccine for school children.

West Virginia: SB 318 would require all healthcare workers to get the flu shot every year. HB 2945 and SB 330 would establish religious and conscientious belief exemptions to vaccination.

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USDA Forgives and Forgets: Fraudulent Organics Certifier to be Reinstated

Organic certifier, banned in EU and Canada, to be reinstated by US. Action Alert!

Sources at the US Department of Agriculture (USDA) have told us that they are planning to recertify ETKO, a Turkish-based organic certifier. As we’ve reported previously, ETKO has been singled out by some countries, notably Canada and the European Union, for its fraudulent certifications. These countries have “decertified” the organization—meaning that they no longer accept ETKO-certified products as organic.

The USDA has had problems with ETKO as far back as 2009, but instead of decertifying this company, it actually reached a settlement agreement with them in 2016. The firm has been under audit by USDA for about a year.

Millions of pounds of fake organic products from overseas have been flooding US markets and threatening domestic producers who follow the rules. One would think that the USDA’s organic program would take the matter seriously and protect consumers from fraud. The agency’s dealings with ETKO, however, paint a different picture.

It’s time for the USDA to protect consumers, domestic farmers, and the integrity of the organic seal by holding fraudulent certifiers accountable.

Action Alert! Write to the USDA and tell them NOT to recertify ETKO. Please send your message immediately.

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FDA Back Channel Lets Pharma Turn Nutrients Into Drugs

Supplements become drugs and you pay. Tell FDA- Not this time! Action Alert!

By failing to finalize a key supplement policy, the FDA has provided a way for pharmaceutical companies to take natural compounds and turn them into costly drugs. The longer the agency delays, the greater the danger that more and more nutrients will be nabbed by pharmaceutical companies, forcing cheaper supplement forms from the market.

L-glutamine is the most recent example. Last year, the FDA announced the approval of a new drug for sickle cell disease called Endari. Endari is an oral powder comprised of L-glutamine, an important amino acid. The drug company, Emmaus Medical, Inc., says in its materials that an IND (investigational new drug) application for L-glutamine was originally filed on May 15, 1997. According to the FDA’s website, there is no new dietary ingredient (NDI) notification for L-glutamine.

If a drug company files an IND application on a nutrient before an NDI notification on that nutrient is filed, the company can ask the FDA to have supplement version removed from the market.

This means Emmaus can enforce its IND and petition the FDA to remove all L-glutamine supplements from the market, at any time. Keep in mind this is the same thing that happened to the pyridoxamine version of vitamin B6 in 2008, and is fast becoming a standard business practice for Big Pharma.

If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides to consider L-glutamine an “old dietary ingredient” (ODI) that does not require an NDI notification. In other words, a company would have to prove that L-glutamine was marketed “in or as” a dietary supplement before 1994.

This is a key point, and another tactic the FDA has used to benefit the pharmaceutical industry. Defining an ODI as a substance marketed “in or as” a supplement, rather than anything “sold” or in the food supply before 1994 as Congress intended, is an FDA invention. Fewer supplements will qualify as ODIs under FDA’s definition, which means more nutrients could become Big Pharma’s next target.

This would be a critical loss. L-glutamine helps maintain muscle, boosts the immune system, supports gastrointestinal health, and helps to maintain healthy growth hormone levels.

The crux of the problem is the FDA’s NDI notification guidance that we’ve been writing about since the revised draft was released in August 2016. It has now been 24 years since the Dietary Supplement Health and Education Act (DSHEA) was passed, and the supplement industry has been waiting for the NDI policy ever since. Supplement companies do not know which supplements require an NDI notification or the requirements and protocol necessary for such a submission. In the meantime, pharmaceutical companies are taking advantage of the confusion by snatching up nutrients and turning them into drugs.

The FDA must solidify its NDI notification policy, but finalizing the draft guidance in its current form is unacceptable. As we wrote in 2016, defining ODIs as substances marketed “in or as” a supplement before 1994 was an improvement over the original guidance—but it’s not good enough and will mean many more supplements that consumers rely on could be eliminated. ODIs should be defined as supplements sold in the food supply, in any form, before 1994, period. The agency must fix the problems with the draft guidance, and then finalize the guidance.

Action Alert! Tell the FDA to fix the NDI guidance, and then finalize it to prevent more natural medicines from being taken by the pharmaceutical industry. Please send your message immediately.

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FDA Back Channel Lets Pharma Turn Nutrients Into Drugs

Supplements become drugs and you pay. Tell FDA- Not this time! Action Alert!

By failing to finalize a key supplement policy, the FDA has provided a way for pharmaceutical companies to take natural compounds and turn them into costly drugs. The longer the agency delays, the greater the danger that more and more nutrients will be nabbed by pharmaceutical companies, forcing cheaper supplement forms from the market.

L-glutamine is the most recent example. Last year, the FDA announced the approval of a new drug for sickle cell disease called Endari. Endari is an oral powder comprised of L-glutamine, an important amino acid. The drug company, Emmaus Medical, Inc., says in its materials that an IND (investigational new drug) application for L-glutamine was originally filed on May 15, 1997. According to the FDA’s website, there is no new dietary ingredient (NDI) notification for L-glutamine.

If a drug company files an IND application on a nutrient before an NDI notification on that nutrient is filed, the company can ask the FDA to have supplement version removed from the market.

This means Emmaus can enforce its IND and petition the FDA to remove all L-glutamine supplements from the market, at any time. Keep in mind this is the same thing that happened to the pyridoxamine version of vitamin B6 in 2008, and is fast becoming a standard business practice for Big Pharma.

If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides to consider L-glutamine an “old dietary ingredient” (ODI) that does not require an NDI notification. In other words, a company would have to prove that L-glutamine was marketed “in or as” a dietary supplement before 1994.

This is a key point, and another tactic the FDA has used to benefit the pharmaceutical industry. Defining an ODI as a substance marketed “in or as” a supplement, rather than anything “sold” or in the food supply before 1994 as Congress intended, is an FDA invention. Fewer supplements will qualify as ODIs under FDA’s definition, which means more nutrients could become Big Pharma’s next target.

This would be a critical loss. L-glutamine helps maintain muscle, boosts the immune system, supports gastrointestinal health, and helps to maintain healthy growth hormone levels.

The crux of the problem is the FDA’s NDI notification guidance that we’ve been writing about since the revised draft was released in August 2016. It has now been 24 years since the Dietary Supplement Health and Education Act (DSHEA) was passed, and the supplement industry has been waiting for the NDI policy ever since. Supplement companies do not know which supplements require an NDI notification or the requirements and protocol necessary for such a submission. In the meantime, pharmaceutical companies are taking advantage of the confusion by snatching up nutrients and turning them into drugs.

The FDA must solidify its NDI notification policy, but finalizing the draft guidance in its current form is unacceptable. As we wrote in 2016, defining ODIs as substances marketed “in or as” a supplement before 1994 was an improvement over the original guidance—but it’s not good enough and will mean many more supplements that consumers rely on could be eliminated. ODIs should be defined as supplements sold in the food supply, in any form, before 1994, period. The agency must fix the problems with the draft guidance, and then finalize the guidance.

Action Alert! Tell the FDA to fix the NDI guidance, and then finalize it to prevent more natural medicines from being taken by the pharmaceutical industry. Please send your message immediately.

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Action Alert: Remove Pew from PCAC!

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Action Alert: Remove Pew from PCAC!

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2 Minute Warning February 15, 2018

This week’s featured stories:

• GMO mosquitos loosed in south Florida
• FDA back channel allows drug companies to turn nutrients into drugs
• Advisory panel on compounding rife with conflicts of interest

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Pharma Pirates Creating CBD Monopoly (With FDA Assistance)

Action Alert

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2 Minute Warning February 15, 2018

This week’s featured stories:

• GMO mosquitos loosed in south Florida
• FDA back channel allows drug companies to turn nutrients into drugs
• Advisory panel on compounding rife with conflicts of interest

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Pharma Pirates Creating CBD Monopoly (With FDA Assistance)

Action Alert

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By ICIM member’s Coleen and Conrad Maulfair, DO: Toxic time bombs: The pollution in you

Fatigue, allergies, joint aches or mood swings got you down? Although concern over the effects of pollution on the environment has held our attention for decades, new research is detecting chemical toxins in most people.[1;2] While industry furiously challenges the evidence, scientists argue that low-level chemical exposures are linked with these subtle but all too common problems, not to mention diseases such as autism, ADHD, and cancer, to name a few. Long term, low level exposures to chemicals cause an accumulation in the body referred to as “body burden.”

As we gain increasing understanding about the adverse effects of body burden on health what remains less clear is when the time bomb may go off. The medical community is trained to look to yesterday’s exposure to explain today’s symptoms. Yet, body burden, accumulations of toxic chemicals, may have more subtle but important health effects that are not seen for years, or even lifetimes. Because of this time delay, it is not uncommon for a chemical to be banned for safety concerns after decades of use — a real world experiment.

Studies link ZIP codes near waste sites with low-birth-weight babies, thyroid disease in women and female reproductive disorders such as endometriosis — even in regions with higher per capita income, less smoking, better diet and more exercise.[3] The same researchers have data linking living near waste sites to elevated risks for stroke, ischemic heart disease, high blood pressure and cancer.

Our life support system: Better living through chemistry?
You don’t live near an industrial waste site? The truth is that even if you do, you probably get most of your toxins as pesticides and additives in your food or each time you apply various consumer cosmetic products. Your home, your cars and even the water you drink slowly leak chemicals into your life.

There has been a staggering proliferation of toxic chemicals produced without due regard for testing for long-term health effects of low level exposures. Thousands of new synthetic chemicals come into manufactured consumer products every year with little to no safety testing or public approval process. According to the World Health Organization, there are over 100,000 synthetic chemicals in use in consumer products today with 1,000 to 2,000 being added to the list each year.

We breathe these chemicals through our lungs, absorb them through our skin and ingest them in the food we eat and water we drink. We are soaking up chemicals that we’d be hard-pressed to spell or pronounce, if we could even find out what they were.

The body burden problem
Toxic chemicals know no boundaries. Chemicals contaminate not only wildlife and the environment, but people, breast milk and the unborn child yet most people are unaware that they carry chemical compounds in their bodies. Each of us has some load of industrial chemicals stored in or passing through our bodies. Human fat tissue sampled in the United States contained 700 contaminants that have not been chemically identified.[4]

According to Michael McCally, M.D. Ph.D., of Mt. Sinai School of Medicine, “Current ‘normal’ body burdens of dioxin and several other well-studied organochlorides are at or near the range at which toxic effects occur in laboratory animals.” A recent Mt Sinai study found 167 chemicals in the blood and urine of volunteers; chemicals used in consumer products and found in industrial pollution.[2] Of the 167 chemicals discovered, 94 are toxic to the brain or nervous system, 76 are carcinogenic (cancer-causing) and 79 are linked to birth defects. None of the participants worked with chemicals or lived near an industrial facility. In other words, these toxins represent the average body burden of the ordinary American citizen.

This is not a uniquely American problem. A 2005 British study funded by the World Wide Fund for Nature and the Co-Operative Bank found chemicals including banned pesticides like DDT, flame retardants and the PFOA chemical found in Teflon and used on nonstick pans and stain repellents.

If the body burden of adults isn’t enough cause for alarm, it is shocking to learn the effects on future generations. In 2005, the US Environmental Working Group [5] reported that umbilical cord blood samples taken from newborn babies were all heavily contaminated. A total of 287 contaminants were detected. Many of these were known or suspected carcinogens, neurotoxins or linked with birth defects if present in high concentrations. Meanwhile, an exhaustive review of the evidence points to prenatal exposures as a source of postnatal mental deficits.[6]

Scientists have never assessed the effects of exposures to the endless combinations of chemicals found in people. One reason why measuring such effects is difficult is that these chemicals are persistent (meaning they do not break down) and bioaccumulative (meaning they tend to build up in living things, particularly areas of the body rich in fat such as fatty tissue, brain and other organs).

Our understanding of when a chemical is toxic is changing and concerned individuals are calling for laws to regulate these compounds more carefully. However, because of their widespread use, tendency to persist and accumulation in body tissues — especially fat — even regulatory changes will not remove them from our world very quickly.

While we wait for industry, government and science to reach agreement, the vast increase of chemicals in our environment, foods, cosmetics and medicines puts an enormous burden on our bodies’ natural abilities to break down and remove toxins. With the exception of certain minerals, these chemicals do not belong in the body. While minerals are needed at low levels for normal function, some are now found measured at high or even toxic concentrations.

Most people wait too long to do something about it
The good news is that something can be done about the toxins in our bodies. Our livers, lungs, kidneys are constantly working overtime to remove the onslaught of chemicals. To function properly, these systems require broad nutritional support. When we don’t give our body what it needs to help it eliminate these chemicals or when we expose it to more than it can handle, it just can’t keep up. Symptoms such as fatigue, aches, allergies, asthma, mood swings, foggy thinking, and more set in. Before this happens — and even afterwards — the correct detoxification program can make all the difference.

The Maulfair Medical Center uses the Hubbard method of detoxification, the most thorough and scientifically validated regimen available. This precise regimen combines exercise, sauna bathing, and vitamin and mineral supplementation to increase the elimination of chemicals while rebuilding and repairing your body. Its safety and effectiveness in treating a wide range of exposures have been established for more than two decades.[7;8]

Originally developed by Hubbard in 1979, this program has been successfully used to aid individuals exposed during large-scale environmental contaminations, including those resulting from the 2001 World Trade Center disaster [9] and the 1986 Chernobyl incident [10]. Thousands of people have enjoyed relief from symptoms caused by more gradual build-up of toxins.

Sauna detoxification at the Maulfair Medical Center
Dr. Maulfair gets you started on your sauna program with a thorough medical examination and a series of key tests plus a complete physical exam. Tests may include a pre and post assessment of toxic body burden and some tests may be repeated periodically, to monitor your status while on the regimen.

Dr. Maulfair has over thirty years experience utilizing detoxification regimens to treat chronic disease. Join those clients of the Maulfair Medical Center’s program who have gained back their quality of life, enjoy restored energy, clear thinking, motivation and an overall sense of well being. For more information see www.drmaulfair.com

Dr. Conrad Maulfair
Maulfair Medical Center, Topton, PA

Reference List

1. Calafat AM, Wong LY, Kuklenyik Z, Reidy JA, Needham LL: Polyfluoroalkyl chemicals in the U.S. population: data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004 and comparisons with NHANES 1999-2000. Environ Health Perspect 2007; 115: 1596-602.
2. Environmental Working Group. Body Burden: The pollution in people [Web Page]. 2003; Accessed 2008 Feb 20. Available at: http://archive.ewg.org/reports/bodyburden1/
3. Baibergenova A, Kudyakov R, Zdeb M, Carpenter DO: Low birth weight and residential proximity to PCB-contaminated waste sites. Environ Health Perspect 2003; 111: 1352-7.
4. Onstot, J., Ayling, R., and Stanley, J. Characterization of HRCG/MS unidentified peaks from the analysis of human adipose tissue. Vol. 1: Technical Approach. 87. Washington DC, US Environmental Protection Agency Office of toxic Substances.
5. Environmental Working Group. Body Burden: The pollution in newborns [Web Page]. 2005; Accessed 2008 Feb 20. Available at: http://archive.ewg.org/reports/bodyburden2/execsumm.php. 
6. Williams JH, Ross L: Consequences of prenatal toxin exposure for mental health in children and adolescents: a systematic review. Eur Child Adolesc Psychiatry 2007; 16: 243-53.
7. Schnare DW, Denk G, Shields M, Brunton S: Evaluation of a detoxification regimen for fat stored xenobiotics. Med Hypotheses 1982; 9: 265-82.
8. Schnare, D. W., Ben, M., and Shields, M. G. Body Burden Reduction of PCBs, PBBs and Chlorinated Pesticides in Human Subjects. Ambio 1984; 13(5-6): 378-380.
9. Cecchini MA, Root DA, Rachunow JR, Gelb PM: Chemical Exposures at the World Trade Center: Use of the Hubbard Sauna Detoxification Regimen to Improve the Health Status of New York City Rescue Workers Exposed to Toxicants. Townsend Letter for Doctors and Patients 2006; 273: 58-65.
10. Tsyb, A. F., Parshkov, E. M., Barnes, J., Yarzutkin, V. V. , Vorontsov, N. V., and Dedov, V. I. Rehabilitation of a Chernobyl Affected Population Using a Detoxification Method. Proceedings of the 1998 International Radiological Postemergency Response Issues Conference. 1998. U.S. Environmental Protection Agency.

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By ICIM member’s Coleen and Conrad Maulfair, DO: Toxic time bombs: The pollution in you

Fatigue, allergies, joint aches or mood swings got you down? Although concern over the effects of pollution on the environment has held our attention for decades, new research is detecting chemical toxins in most people.[1;2] While industry furiously challenges the evidence, scientists argue that low-level chemical exposures are linked with these subtle but all too common problems, not to mention diseases such as autism, ADHD, and cancer, to name a few. Long term, low level exposures to chemicals cause an accumulation in the body referred to as “body burden.”

As we gain increasing understanding about the adverse effects of body burden on health what remains less clear is when the time bomb may go off. The medical community is trained to look to yesterday’s exposure to explain today’s symptoms. Yet, body burden, accumulations of toxic chemicals, may have more subtle but important health effects that are not seen for years, or even lifetimes. Because of this time delay, it is not uncommon for a chemical to be banned for safety concerns after decades of use — a real world experiment.

Studies link ZIP codes near waste sites with low-birth-weight babies, thyroid disease in women and female reproductive disorders such as endometriosis — even in regions with higher per capita income, less smoking, better diet and more exercise.[3] The same researchers have data linking living near waste sites to elevated risks for stroke, ischemic heart disease, high blood pressure and cancer.

Our life support system: Better living through chemistry?
You don’t live near an industrial waste site? The truth is that even if you do, you probably get most of your toxins as pesticides and additives in your food or each time you apply various consumer cosmetic products. Your home, your cars and even the water you drink slowly leak chemicals into your life.

There has been a staggering proliferation of toxic chemicals produced without due regard for testing for long-term health effects of low level exposures. Thousands of new synthetic chemicals come into manufactured consumer products every year with little to no safety testing or public approval process. According to the World Health Organization, there are over 100,000 synthetic chemicals in use in consumer products today with 1,000 to 2,000 being added to the list each year.

We breathe these chemicals through our lungs, absorb them through our skin and ingest them in the food we eat and water we drink. We are soaking up chemicals that we’d be hard-pressed to spell or pronounce, if we could even find out what they were.

The body burden problem
Toxic chemicals know no boundaries. Chemicals contaminate not only wildlife and the environment, but people, breast milk and the unborn child yet most people are unaware that they carry chemical compounds in their bodies. Each of us has some load of industrial chemicals stored in or passing through our bodies. Human fat tissue sampled in the United States contained 700 contaminants that have not been chemically identified.[4]

According to Michael McCally, M.D. Ph.D., of Mt. Sinai School of Medicine, “Current ‘normal’ body burdens of dioxin and several other well-studied organochlorides are at or near the range at which toxic effects occur in laboratory animals.” A recent Mt Sinai study found 167 chemicals in the blood and urine of volunteers; chemicals used in consumer products and found in industrial pollution.[2] Of the 167 chemicals discovered, 94 are toxic to the brain or nervous system, 76 are carcinogenic (cancer-causing) and 79 are linked to birth defects. None of the participants worked with chemicals or lived near an industrial facility. In other words, these toxins represent the average body burden of the ordinary American citizen.

This is not a uniquely American problem. A 2005 British study funded by the World Wide Fund for Nature and the Co-Operative Bank found chemicals including banned pesticides like DDT, flame retardants and the PFOA chemical found in Teflon and used on nonstick pans and stain repellents.

If the body burden of adults isn’t enough cause for alarm, it is shocking to learn the effects on future generations. In 2005, the US Environmental Working Group [5] reported that umbilical cord blood samples taken from newborn babies were all heavily contaminated. A total of 287 contaminants were detected. Many of these were known or suspected carcinogens, neurotoxins or linked with birth defects if present in high concentrations. Meanwhile, an exhaustive review of the evidence points to prenatal exposures as a source of postnatal mental deficits.[6]

Scientists have never assessed the effects of exposures to the endless combinations of chemicals found in people. One reason why measuring such effects is difficult is that these chemicals are persistent (meaning they do not break down) and bioaccumulative (meaning they tend to build up in living things, particularly areas of the body rich in fat such as fatty tissue, brain and other organs).

Our understanding of when a chemical is toxic is changing and concerned individuals are calling for laws to regulate these compounds more carefully. However, because of their widespread use, tendency to persist and accumulation in body tissues — especially fat — even regulatory changes will not remove them from our world very quickly.

While we wait for industry, government and science to reach agreement, the vast increase of chemicals in our environment, foods, cosmetics and medicines puts an enormous burden on our bodies’ natural abilities to break down and remove toxins. With the exception of certain minerals, these chemicals do not belong in the body. While minerals are needed at low levels for normal function, some are now found measured at high or even toxic concentrations.

Most people wait too long to do something about it
The good news is that something can be done about the toxins in our bodies. Our livers, lungs, kidneys are constantly working overtime to remove the onslaught of chemicals. To function properly, these systems require broad nutritional support. When we don’t give our body what it needs to help it eliminate these chemicals or when we expose it to more than it can handle, it just can’t keep up. Symptoms such as fatigue, aches, allergies, asthma, mood swings, foggy thinking, and more set in. Before this happens — and even afterwards — the correct detoxification program can make all the difference.

The Maulfair Medical Center uses the Hubbard method of detoxification, the most thorough and scientifically validated regimen available. This precise regimen combines exercise, sauna bathing, and vitamin and mineral supplementation to increase the elimination of chemicals while rebuilding and repairing your body. Its safety and effectiveness in treating a wide range of exposures have been established for more than two decades.[7;8]

Originally developed by Hubbard in 1979, this program has been successfully used to aid individuals exposed during large-scale environmental contaminations, including those resulting from the 2001 World Trade Center disaster [9] and the 1986 Chernobyl incident [10]. Thousands of people have enjoyed relief from symptoms caused by more gradual build-up of toxins.

Sauna detoxification at the Maulfair Medical Center
Dr. Maulfair gets you started on your sauna program with a thorough medical examination and a series of key tests plus a complete physical exam. Tests may include a pre and post assessment of toxic body burden and some tests may be repeated periodically, to monitor your status while on the regimen.

Dr. Maulfair has over thirty years experience utilizing detoxification regimens to treat chronic disease. Join those clients of the Maulfair Medical Center’s program who have gained back their quality of life, enjoy restored energy, clear thinking, motivation and an overall sense of well being. For more information see www.drmaulfair.com

Dr. Conrad Maulfair
Maulfair Medical Center, Topton, PA

Reference List

1. Calafat AM, Wong LY, Kuklenyik Z, Reidy JA, Needham LL: Polyfluoroalkyl chemicals in the U.S. population: data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004 and comparisons with NHANES 1999-2000. Environ Health Perspect 2007; 115: 1596-602.
2. Environmental Working Group. Body Burden: The pollution in people [Web Page]. 2003; Accessed 2008 Feb 20. Available at: http://archive.ewg.org/reports/bodyburden1/
3. Baibergenova A, Kudyakov R, Zdeb M, Carpenter DO: Low birth weight and residential proximity to PCB-contaminated waste sites. Environ Health Perspect 2003; 111: 1352-7.
4. Onstot, J., Ayling, R., and Stanley, J. Characterization of HRCG/MS unidentified peaks from the analysis of human adipose tissue. Vol. 1: Technical Approach. 87. Washington DC, US Environmental Protection Agency Office of toxic Substances.
5. Environmental Working Group. Body Burden: The pollution in newborns [Web Page]. 2005; Accessed 2008 Feb 20. Available at: http://archive.ewg.org/reports/bodyburden2/execsumm.php. 
6. Williams JH, Ross L: Consequences of prenatal toxin exposure for mental health in children and adolescents: a systematic review. Eur Child Adolesc Psychiatry 2007; 16: 243-53.
7. Schnare DW, Denk G, Shields M, Brunton S: Evaluation of a detoxification regimen for fat stored xenobiotics. Med Hypotheses 1982; 9: 265-82.
8. Schnare, D. W., Ben, M., and Shields, M. G. Body Burden Reduction of PCBs, PBBs and Chlorinated Pesticides in Human Subjects. Ambio 1984; 13(5-6): 378-380.
9. Cecchini MA, Root DA, Rachunow JR, Gelb PM: Chemical Exposures at the World Trade Center: Use of the Hubbard Sauna Detoxification Regimen to Improve the Health Status of New York City Rescue Workers Exposed to Toxicants. Townsend Letter for Doctors and Patients 2006; 273: 58-65.
10. Tsyb, A. F., Parshkov, E. M., Barnes, J., Yarzutkin, V. V. , Vorontsov, N. V., and Dedov, V. I. Rehabilitation of a Chernobyl Affected Population Using a Detoxification Method. Proceedings of the 1998 International Radiological Postemergency Response Issues Conference. 1998. U.S. Environmental Protection Agency.

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Conventional Medicine Claims Another Casualty

An 8-year-old boy died from complications arising from a scrape on his thigh.

From Fox News:

When the second-grader took a tumble off his bike on the driveway of his family’s farm in Pilot Rock, Ore., and suffered a large gash on his thigh he didn’t panic. His mom, Sara Hebard, rushed him to the emergency room, where he was given seven stitches… But within days, Flanagan’s pain seemed to get worse. As a precaution, Hebard decided to take him back to the hospital, where she was shocked to discover flesh-eating bacteria had spread from Flanagan’s ankle to his armpit.

Comment: Once again, conventional medicine refuses to consider natural remedies that are safe and effective—especially in our “post-antibiotic era” where conventional antibiotics don’t work—because natural medicines are cheap and lack profit potential. Bacteria cannot develop resistance to natural antibiotics like Manuka honey, silver, or even iodine (combined with dimethyl sulfoxide to carry it through the skin). This story also underscores the danger of hospital-spread infections. Hospital errors are the third leading cause of death in the US. Put differently, 10% of US deaths are due to preventable medical mistakes.

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Conventional Medicine Claims Another Casualty

An 8-year-old boy died from complications arising from a scrape on his thigh.

From Fox News:

When the second-grader took a tumble off his bike on the driveway of his family’s farm in Pilot Rock, Ore., and suffered a large gash on his thigh he didn’t panic. His mom, Sara Hebard, rushed him to the emergency room, where he was given seven stitches… But within days, Flanagan’s pain seemed to get worse. As a precaution, Hebard decided to take him back to the hospital, where she was shocked to discover flesh-eating bacteria had spread from Flanagan’s ankle to his armpit.

Comment: Once again, conventional medicine refuses to consider natural remedies that are safe and effective—especially in our “post-antibiotic era” where conventional antibiotics don’t work—because natural medicines are cheap and lack profit potential. Bacteria cannot develop resistance to natural antibiotics like Manuka honey, silver, or even iodine (combined with dimethyl sulfoxide to carry it through the skin). This story also underscores the danger of hospital-spread infections. Hospital errors are the third leading cause of death in the US. Put differently, 10% of US deaths are due to preventable medical mistakes.

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Senator McCain’s Cancer Treatment Reveals the Problem

Why cheaper and safer medicine is always ignored.

From The Daily Caller:

Republican Sen. John McCain left Washington, D.C., Sunday to be with his family in Arizona, and will miss the vote on the Tax Cuts and Jobs Act expected this week, CBS News reports.

McCain, 81, spent most of the week at Walter Reed National Military Medical Center in Bethesda, Md., following a routine chemotherapy treatment for brain cancer, but is doing well and is in “good spirits,” McCain’s son-in-law, Ben Domenech, told CBS’ Face The Nation Sunday.

Comment: We’ve had our differences with Sen. McCain, most notably his introduction of legislation that would have given the FDA more power over the supplement industry, but we wish him well in his treatment. We also wish that the senator would consider integrative treatments for his glioblastoma. Even with surgery and chemotherapy, patients with this type of brain cancer are generally given about 15 months to live. This might be because mounting evidence shows that chemotherapy and radiation don’t produce any significant improvements in cancer survival rates, because cancer stem cells are resistant to these treatments. This means, tragically, that patients like Sen. McCain are put through the misery of chemo for little benefit. Meanwhile, many natural compounds like turmeric have demonstrated the ability to attack cancers at their root; the only problem is that turmeric is cheap and natural. We see this happen too often in modern medicine: cheap, natural medicine is neglected in favor of expensive treatments and patented drugs that make hospitals and pharmaceutical companies rich.

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Senator McCain’s Cancer Treatment Reveals the Problem

Why cheaper and safer medicine is always ignored.

From The Daily Caller:

Republican Sen. John McCain left Washington, D.C., Sunday to be with his family in Arizona, and will miss the vote on the Tax Cuts and Jobs Act expected this week, CBS News reports.

McCain, 81, spent most of the week at Walter Reed National Military Medical Center in Bethesda, Md., following a routine chemotherapy treatment for brain cancer, but is doing well and is in “good spirits,” McCain’s son-in-law, Ben Domenech, told CBS’ Face The Nation Sunday.

Comment: We’ve had our differences with Sen. McCain, most notably his introduction of legislation that would have given the FDA more power over the supplement industry, but we wish him well in his treatment. We also wish that the senator would consider integrative treatments for his glioblastoma. Even with surgery and chemotherapy, patients with this type of brain cancer are generally given about 15 months to live. This might be because mounting evidence shows that chemotherapy and radiation don’t produce any significant improvements in cancer survival rates, because cancer stem cells are resistant to these treatments. This means, tragically, that patients like Sen. McCain are put through the misery of chemo for little benefit. Meanwhile, many natural compounds like turmeric have demonstrated the ability to attack cancers at their root; the only problem is that turmeric is cheap and natural. We see this happen too often in modern medicine: cheap, natural medicine is neglected in favor of expensive treatments and patented drugs that make hospitals and pharmaceutical companies rich.

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Turning Vitamins Into Gold

How Pharma is stealing nature and charging you for it

From Gizmodo:

If you would like to take niacin, a B vitamin that is believed to lower cholesterol and the chance of having a heart attack, you could buy a month’s supply online for about $5. Or you could get a prescription for a bottle of virtually the same pills for almost $300, thanks to a pharmaceutical company using price gouging tactics similar to those of Pharma Bro Marin Shkrelli, according to a report from the Financial Times.

Comment: With drug after drug failing clinical trials (see the recent spate of failed Alzheimer’s drugs), Big Pharma is increasingly turning to natural medicine. This happened recently with Vascepa, an FDA-approved fish oil drug to treat high triglycerides which can run consumers as much as $300 for a one-month supply. Now the same thing has happened to niacin, which one company has turned into a prescription drug to treat cholesterol. What’s next?

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Turning Vitamins Into Gold

How Pharma is stealing nature and charging you for it

From Gizmodo:

If you would like to take niacin, a B vitamin that is believed to lower cholesterol and the chance of having a heart attack, you could buy a month’s supply online for about $5. Or you could get a prescription for a bottle of virtually the same pills for almost $300, thanks to a pharmaceutical company using price gouging tactics similar to those of Pharma Bro Marin Shkrelli, according to a report from the Financial Times.

Comment: With drug after drug failing clinical trials (see the recent spate of failed Alzheimer’s drugs), Big Pharma is increasingly turning to natural medicine. This happened recently with Vascepa, an FDA-approved fish oil drug to treat high triglycerides which can run consumers as much as $300 for a one-month supply. Now the same thing has happened to niacin, which one company has turned into a prescription drug to treat cholesterol. What’s next?

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Terminal Patients Find Hope in State of Union

President touts ‘Right to Try’ legislation we have been supporting. Action Alert!

In his address, President Trump said:

We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure—I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’

Legislation has been approved in the Senate but is stalled in the House of Representatives. The bill expands access to experimental drugs for terminally ill patients who have exhausted all other treatment options. See our recent coverage for more details.

ANH-USA has supported this legislation for quite some time—we worked with former Representative Ron Paul (R-TX) on the first iteration of the legislation. When Rep. Paul retired, we began working with Rep. Morgan Griffith (R-VA) on the issue. Rep. Griffith’s bill is one of two right to try bills in the House. For years the federal government failed to enact the legislation, so states took matters into their own hands: 38 states have passed right to try laws.

Dying patients deserve a right to pursue experimental treatments. Help us bring this long overdue law across the finish line.

Action alert! Write to your member of Congress and urge him or her to support the federal Right to Try bills. Please send your message immediately.

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More Vaccine Mandates for Kids?

Check if your state is further limiting vaccine choice. State-based Action Alerts!

A new year brings a flurry of legislative activity. Many states will be considering bills that limit vaccine choice, whether by eliminating or restricting exemptions or mandating vaccines for children or certain workers.

Patients deserve a right to decide which medical treatments to receive, especially when there are safety concerns. There is also plenty of scientific data that throws the safety of vaccine ingredients into serious question. Take aluminum, for example—a common vaccine ingredient:

• Aluminum is a well-documented neurotoxinthat has been linked with Alzheimer’s disease, epilepsy, asthma, hyperactivity, and Down’s Syndrome.
• The FDAhas set a limit on the amount of aluminum that can be in vaccines, but this number was based on the amount of aluminum required to enhance the effectiveness of the vaccine. The agency has not empirically determined the safest amount of intramuscularly injected aluminum, relying instead on the hope that current levels are safe. Note the word “injected.” It is one thing for the body to handle aluminum in our food, because our liver protects us. But it can’t protect us when we are injected with poison.
• New studiesprovide stunning information about what happens to aluminum after it’s injected into muscle. In some mice, it travels to the brain, where it can still be detected a year later. It also travels to the spleen and lymph nodes, where it can still be detected 270 days after vaccination.

In addition to concerns about ingredients—including the mercury that is used as a preservative in flu shots, even for children—the national vaccine schedule has never been rigorously evaluated for safety. This was the determination not of some “anti-vaxxer” group, but of the National Academy of Medicine (formerly the Institute of Medicine), which advises the government on issues relating to medicine and health. In a 2013 report, the Academy concluded, “Key elements of the schedule—the number, frequency, timing, order, and age at administration of vaccines—have not been systematically examined in research studies.”

Click on your states link below to see what bills are pending and take action!

FL
HI
IA
IL
KS
ME
MN
MO
MS
NH
NJ
NY
OK
PA
RI
VA
WV

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