Compounded Meds Will Cost You More (or Disappear Altogether!) Because of FDA’s Attack on “Office Use”

Once again the rogue agency is thumbing its nose at members of Congress. Action Alert!

Last week we told you about the new threat to compounded drugs from the US Pharmacopeial Convention (USP) and asked you to send a protest message to USP. Our thanks to the many thousands of you who responded. Now the US Food and Drug Administration is dramatically increasing the cost of compounded drugs and is once again interfering with the practice of medicine. At issue is what is called “office use.”

As we explained in 2012, “office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances a doctor would need to have a reserve supply of compounded drugs on hand without a prescription. Pharmacies might be called upon to repackage manufactured drugs to produce various compounded formulations in advance of a prescription—especially if they know they have a standing order on certain formulations.

Now the FDA, purportedly based on underlying congressional action, appears to be trying to kill office use and pharmacy repackaging. In a response to a letter from concerned members of Congress, the FDA stated, “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.” The agency has also sent a warning letter to a pharmacy regarding its alleged office use “violation.”

As a result, there has been tremendous confusion in the medical community and among state pharmacy boards. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use. This means the FDA is actively interfering with the practice of medicine.

Doctors will now have to go through bureaucratic rigmarole and delay for each drug and each patient, which makes access to compounded drugs very difficult for patients and increases the cost of the medicine significantly. ANH-USA heard from one doctor, who described his real-world experience with office-use compounding:

I have occasion to see people with degenerative joint disease. One of the best treatments to inexpensively help the body regenerate cartilage and stop joint pain is to inject glucosamine, MSM, and methyl-B12 or hydroxy-B12 into the joint. This works so much better than injecting cortisone, and is not destructive to the cartilage as is cortisone.

Just last year I could keep bottles of these ingredients and use them in patients as needed throughout the day.

Now, I need to prescribe the glucosamine, MSM, and B12 for each individual patient, the compounding pharmacy will send the ingredients to the patient and charge for the prescription, the patient will bring the bottled ingredients to my office at their next appointment, and then I can do the injection into the joint. This delays needed treatment, and makes it unduly expensive.

I have occasion to see patients who have fibromyalgia and chronic fatigue syndrome. One of the most important treatments involves the injection of intravenous nutrients. It used to be possible to stock bottles of the several nutrients listed below and put the needed dose into an IV bottle and administer the IV solution.

Now, I need to prescribe the exact dose of each nutrient, each bottle gets charged and sent to the patient in the mail, the patient needs to bring it all to the medical center, my staff needs to put each nutrient into the IV bottle, and then the patient can receive the IV solution.

The cost has dramatically increased. We used to be able to charge about $150 for the solution; it will now cost about $400 under the new rules.

We have been providing safe and quality individualized care for many years with the help of the compounding pharmacists with whom we have relationship. Now we are severely hampered by unneeded regulation.

Several members of Congress have said that when the final version of the compounding legislation was passed, Congress did not intend to place limitations on office use. Historically, office use is addressed in state legislation and has been the purview of the state pharmacy boards.

In fact, several Congress members stated for the Congressional Record that they completely disagree with the FDA’s position on office use:

• Sen. Johnny Isakson (R-GA): “The intent of this legislation is to maintain current law with respect to patients’ and physicians’ access to drugs compounded for office use.”


• Sen. Lamar Alexander (R-TN): “The legislation does not change current law on office use compounding or repackaging.”


• Rep. Morgan Griffith (R-VA): “I know there’s a lot of concern out there by some in the medical community, particularly the doctors and some others, but this does not change the existing law on office use, and it does not change the existing law on repackaging.”

ANH-USA is part of a coalition that is tackling this issue. The coalition, which includes doctors and pharmacists (we are the only organization representing consumer interests), sent a letter to both the Senate Health, Education, Labor, and Pensions Committee and the Energy and Commerce Committee to alert them to the issue. We told them that access to many drugs for office use is being stopped, including:

• Antibiotics for urgent and emergent use in treating ophthalmology patients;


• Buffered lidocaine for use in dermatology procedures;


• Vascular endothelial growth factor inhibitors for use in treating age-related macular degeneration by ophthalmologists;


• Injection therapies for treating erectile dysfunction in urology patients (test injections are commonly administered in the doctor’s office to determine the correct dosage);


• Cantharidin for treating viral skin conditions in office by dermatologists and pediatricians; and


• Injectable methylcobalamin for the treatment of pernicious anemia and other vitamin B-12 deficiencies.

And that’s just the tip of the iceberg when it comes to the medications affected. Of course, these office use restrictions have nothing to do with the New England Compounding Center tragedy that spurred the whole legislation in the first place. Make no mistake: the FDA’s actions only make sense as a way to protect the pharmaceutical industry’s monopoly on drugs. The FDA depends on Pharma, not compounders, to pay its bills and also provide jobs following government service, which is known as the revolving door.

Action Alert! ANH-USA is launching a new microsite that explains and addresses the many serious problems physicians, pharmacists, and patients have with the FDA’s implementation of the compounding law. We will be pursuing legislative fixes, but it all starts with our petition to the FDA. Please go to http://ift.tt/1JZwdf0, learn what’s at stake, and send your messages to Congress and the FDA. Please take action immediately!

Also, if you didn’t do so last week, please send a message to the US Pharmacopeial Convention (USP) and tell them to revise their “hazardous drugs” rule!

from The Alliance for Natural Health USA http://ift.tt/1JZwdvn via Aloe for Health

from http://ift.tt/1DeIWrY

Is Your Sunscreen Making You Infertile?

A new law may help promote safer sunscreen ingredients. Action Alert!

A new study by the National Institutes of Health found that sunscreen chemicals that filter out ultraviolet rays may impair male fertility. There are twenty-nine “benzophenone-type UV filtering chemicals” in personal care products that protect skin and hair from sun damage. Researchers found that men with high exposure to two chemicals in particular had a 30% reduction in their ability to reproduce. Earlier research findings linked reduced fertility to high concentrations of phthalates and Bisphenol A (BPA) in men, chemicals that we also pick up from sources such as can linings, dental treatments, and cash register receipts.

The skin is the body’s largest organ, and how we care for our skin is extremely important. Unfortunately, the FDA’s procedure for reviewing sunscreen ingredients is incredibly sloppy—and way too slow.

The FDA classifies sunscreen as drugs, and all sunscreen products technically require preapproval before being allowed on the market. However, to avoid the lengthy and expensive new drug approval process, sunscreen ingredients are governed by monograph (a written standard for active ingredients). If a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market. It took thirty years for the FDA to approve several final monographs for sunscreen ingredients, but they finally did so in 1999.

Even then they did a bad job. Among the list of approved monographs is one for oxybenzone, which breaks down to 4-OH-BP, one of the two chemicals that cause infertility.

If there is a new and potentially safer sunscreen ingredient, a manufacturer’s viable alternative is the Time and Extent Application. TEAs are meant to allow companies to bring technically new ingredients to the US consumer market, based on their use in other countries. The FDA then is supposed to review the ingredient to see whether it can be Generally Regarded as Safe and Effective (GRASE) for use in sunscreen.

The FDA stated that they would “strive to complete TEA evaluations in 90-180 days”—yet the agency has not approved a TEA for any sunscreen active ingredient since 2002. Only recently did FDA issue a first determination that GRASE status would not be established for two ingredients.

To address this huge delay in sunscreen ingredient review, Congress recently passed the Sunscreen Innovation Act. It will set timelines for FDA review of sunscreen ingredients and, we hope, will give a big boost to innovation and safety. As the Environmental Working Group (EWG) notes:

Companies that make sunscreens in the United States currently have limited options for formulating their products, and most of them provide inadequate protection from UVA rays. [The FDA] has failed to review and approve promising sunscreen ingredients that have been sold for years in Europe, Australia and other countries.

EWG has a guide to the best sunscreens currently available. Dr. Mercola recommends choosing a sunscreen that contains zinc or titanium materials, and has recommendations for other skin-nourishing, safe sunscreens.

Let’s also keep in mind that the human body needs sunlight. Too little sun, whether from being indoors or from using sunscreen or from living in a northern latitude, especially in the winter, is associated with more cancer, not less—especially the deadly cancers, both on the skin and elsewhere. This is probably because it leads to inadequate vitamin D, but there may be many other factors involved that we don’t yet understand. Once you’ve gotten your daily dose of vitamin D from the sun, during times when the sun is powerful enough to make D, especially from 10 a.m. to 2 p.m. in summer, it may be best to avoid sunscreens altogether and wear long sleeves and a hat!

Action Alert! Tell the FDA to remove the monograph for oxybenzone. It’s a dangerous chemical and should immediately be banned from sunscreens. They should also speed up their review of proposed new ingredients. All the delay makes consumers less safe, not more. Send your message today!

from The Alliance for Natural Health USA http://ift.tt/1JZwezC via Aloe for Health

from http://ift.tt/1DeIWbu

Compounded Meds Will Cost You More (or Disappear Altogether!) Because of FDA’s Attack on “Office Use”

Once again the rogue agency is thumbing its nose at members of Congress. Action Alert! Last week we told you about the new threat to compounded drugs from the US Pharmacopeial Convention (USP) and asked you to send a protest message to USP. Our thanks to the many thousands of you who responded. Now the US Food and Drug Administration is dramatically increasing the cost of compounded drugs and is once again interfering with the practice of medicine. At issue is what is called “office use.” As we explained in 2012, “office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances a doctor would need to have a reserve supply of compounded drugs on hand without a prescription. Pharmacies might be called upon to repackage manufactured drugs to produce various compounded formulations in advance of a prescription—especially if they know they have a standing order on certain formulations. Now the FDA, purportedly based on underlying congressional action, appears to be trying to kill office use and pharmacy repackaging. In a response to a letter from concerned members of Congress, the FDA stated, “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.” The agency has also sent a warning letter to a pharmacy regarding its alleged office use “violation.” As a result, there has been tremendous confusion in the medical community and among state pharmacy boards. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use. This means the FDA is actively interfering with the practice of medicine. Doctors will now have to go through bureaucratic rigmarole and delay for each drug and each patient, which makes access to compounded drugs very difficult for patients and increases the cost of the medicine significantly. ANH-USA heard from one doctor, who described his real-world experience with office-use compounding:

I have occasion to see people with degenerative joint disease. One of the best treatments to inexpensively help the body regenerate cartilage and stop joint pain is to inject glucosamine, MSM, and methyl-B12 or hydroxy-B12 into the joint. This works so much better than injecting cortisone, and is not destructive to the cartilage as is cortisone. Just last year I could keep bottles of these ingredients and use them in patients as needed throughout the day. Now, I need to prescribe the glucosamine, MSM, and B12 for each individual patient, the compounding pharmacy will send the ingredients to the patient and charge for the prescription, the patient will bring the bottled ingredients to my office at their next appointment, and then I can do the injection into the joint. This delays needed treatment, and makes it unduly expensive. I have occasion to see patients who have fibromyalgia and chronic fatigue syndrome. One of the most important treatments involves the injection of intravenous nutrients. It used to be possible to stock bottles of the several nutrients listed below and put the needed dose into an IV bottle and administer the IV solution. Now, I need to prescribe the exact dose of each nutrient, each bottle gets charged and sent to the patient in the mail, the patient needs to bring it all to the medical center, my staff needs to put each nutrient into the IV bottle, and then the patient can receive the IV solution. The cost has dramatically increased. We used to be able to charge about $150 for the solution; it will now cost about $400 under the new rules. We have been providing safe and quality individualized care for many years with the help of the compounding pharmacists with whom we have relationship. Now we are severely hampered by unneeded regulation.

Several members of Congress have said that when the final version of the compounding legislation was passed, Congress did not intend to place limitations on office use. Historically, office use is addressed in state legislation and has been the purview of the state pharmacy boards. In fact, several Congress members stated for the Congressional Record that they completely disagree with the FDA’s position on office use:

• Sen. Johnny Isakson (R-GA): “The intent of this legislation is to maintain current law with respect to patients’ and physicians’ access to drugs compounded for office use.”


• Sen. Lamar Alexander (R-TN): “The legislation does not change current law on office use compounding or repackaging.”


• Rep. Morgan Griffith (R-VA): “I know there’s a lot of concern out there by some in the medical community, particularly the doctors and some others, but this does not change the existing law on office use, and it does not change the existing law on repackaging.”

ANH-USA is part of a coalition that is tackling this issue. The coalition, which includes doctors and pharmacists (we are the only organization representing consumer interests), sent a letter to both the Senate Health, Education, Labor, and Pensions Committee and the Energy and Commerce Committee to alert them to the issue. We told them that access to many drugs for office use is being stopped, including:

• Antibiotics for urgent and emergent use in treating ophthalmology patients;


• Buffered lidocaine for use in dermatology procedures;


• Vascular endothelial growth factor inhibitors for use in treating age-related macular degeneration by ophthalmologists;


• Injection therapies for treating erectile dysfunction in urology patients (test injections are commonly administered in the doctor’s office to determine the correct dosage);


• Cantharidin for treating viral skin conditions in office by dermatologists and pediatricians; and


• Injectable methylcobalamin for the treatment of pernicious anemia and other vitamin B-12 deficiencies.

And that’s just the tip of the iceberg when it comes to the medications affected. Of course, these office use restrictions have nothing to do with the New England Compounding Center tragedy that spurred the whole legislation in the first place. Make no mistake: the FDA’s actions only make sense as a way to protect the pharmaceutical industry’s monopoly on drugs. The FDA depends on Pharma, not compounders, to pay its bills and also provide jobs following government service, which is known as the revolving door. Action Alert! ANH-USA is launching a new microsite that explains and addresses the many serious problems physicians, pharmacists, and patients have with the FDA’s implementation of the compounding law. We will be pursuing legislative fixes, but it all starts with our petition to the FDA. Please go to http://ift.tt/1JZwdf0, learn what’s at stake, and send your messages to Congress and the FDA. Please take action immediately!

Also, if you didn’t do so last week, please send a message to the US Pharmacopeial Convention (USP) and tell them to revise their “hazardous drugs” rule!

from The Alliance for Natural Health USA http://ift.tt/1JZwdvn via Aloe for Health

from Tumblr http://ift.tt/1JCYfyA

Is Your Sunscreen Making You Infertile?

A new law may help promote safer sunscreen ingredients. Action Alert! A new study by the National Institutes of Health found that sunscreen chemicals that filter out ultraviolet rays may impair male fertility. There are twenty-nine “benzophenone-type UV filtering chemicals” in personal care products that protect skin and hair from sun damage. Researchers found that men with high exposure to two chemicals in particular had a 30% reduction in their ability to reproduce. Earlier research findings linked reduced fertility to high concentrations of phthalates and Bisphenol A (BPA) in men, chemicals that we also pick up from sources such as can linings, dental treatments, and cash register receipts. The skin is the body’s largest organ, and how we care for our skin is extremely important. Unfortunately, the FDA’s procedure for reviewing sunscreen ingredients is incredibly sloppy—and way too slow. The FDA classifies sunscreen as drugs, and all sunscreen products technically require preapproval before being allowed on the market. However, to avoid the lengthy and expensive new drug approval process, sunscreen ingredients are governed by monograph (a written standard for active ingredients). If a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market. It took thirty years for the FDA to approve several final monographs for sunscreen ingredients, but they finally did so in 1999. Even then they did a bad job. Among the list of approved monographs is one for oxybenzone, which breaks down to 4-OH-BP, one of the two chemicals that cause infertility. If there is a new and potentially safer sunscreen ingredient, a manufacturer’s viable alternative is the Time and Extent Application. TEAs are meant to allow companies to bring technically new ingredients to the US consumer market, based on their use in other countries. The FDA then is supposed to review the ingredient to see whether it can be Generally Regarded as Safe and Effective (GRASE) for use in sunscreen. The FDA stated that they would “strive to complete TEA evaluations in 90-180 days”—yet the agency has not approved a TEA for any sunscreen active ingredient since 2002. Only recently did FDA issue a first determination that GRASE status would not be established for two ingredients. To address this huge delay in sunscreen ingredient review, Congress recently passed the Sunscreen Innovation Act. It will set timelines for FDA review of sunscreen ingredients and, we hope, will give a big boost to innovation and safety. As the Environmental Working Group (EWG) notes:

Companies that make sunscreens in the United States currently have limited options for formulating their products, and most of them provide inadequate protection from UVA rays. [The FDA] has failed to review and approve promising sunscreen ingredients that have been sold for years in Europe, Australia and other countries.

EWG has a guide to the best sunscreens currently available. Dr. Mercola recommends choosing a sunscreen that contains zinc or titanium materials, and has recommendations for other skin-nourishing, safe sunscreens. Let’s also keep in mind that the human body needs sunlight. Too little sun, whether from being indoors or from using sunscreen or from living in a northern latitude, especially in the winter, is associated with more cancer, not less—especially the deadly cancers, both on the skin and elsewhere. This is probably because it leads to inadequate vitamin D, but there may be many other factors involved that we don’t yet understand. Once you’ve gotten your daily dose of vitamin D from the sun, during times when the sun is powerful enough to make D, especially from 10 a.m. to 2 p.m. in summer, it may be best to avoid sunscreens altogether and wear long sleeves and a hat! Action Alert! Tell the FDA to remove the monograph for oxybenzone. It’s a dangerous chemical and should immediately be banned from sunscreens. They should also speed up their review of proposed new ingredients. All the delay makes consumers less safe, not more. Send your message today!

from The Alliance for Natural Health USA http://ift.tt/1JZwezC via Aloe for Health

from Tumblr http://ift.tt/1z0ajGY

Wi-Fi Especially Dangerous for Young Children—Cell Phones Too

Kids exposed to EMF radiation may develop cancer later in life, and the risk is much greater than previously thought.

Should we really be all that concerned about radiation from our cell phones (which we carry with us everywhere) and our Wi-Fi (which is nearly ubiquitous these days)?

The UN’s International Agency for Research on Cancer calls microwave radiation (MWR) a class 2B carcinogen, which means it possibly causes cancer in humans—it’s in the same category as lead, chloroform, gasoline fumes, and the pesticide DDT. Most of the research concerns a specific type of MWR: the radiofrequency electromagnetic fields (RF/EMF) given off by radios, televisions, microwave ovens, cell phones and Wi-Fi, and the smart meters installed in your home by the utility company.

A new study published in the Journal of Microscopy and Ultrastructure says we are right to be concerned. Children are at dramatically greater risk from RF/EMF than adults because their brain tissues are more absorbent, their skulls are thinner, and their relative size is smaller.

In general, the younger the child, the higher the risk, according to the study; fetuses are particularly vulnerable to MWR, which means pregnant women should take great care indeed.

The study also found that adults are at a lower, but still significant, risk, echoing the findings of a 2013 case study from a team of breast cancer surgeons and pathologists who raised the possibility that nonionizing radiation from cell phone EMF exposures caused multifocal invasive breast cancer in four young women. These women, all between the ages of 21 and 39, regularly carried their smartphones directly against their breasts in their bras for up to ten hours a day, for several years. All four developed tumors in areas of their breasts immediately underlying the phones. All four had no family history of breast cancer, tested negative for BRCA1 and BRCA2, and had no other known breast cancer risks. The pathology of all four cases shows striking similarities in the tumor composition.

The youngest of the group started carrying her cell phone in her bra at age 15. The Microscopy and Ultrastructure study made a particular recommendation that adolescent girls and women should never place cell phones in their bras or in hijabs (headscarves).

The study noted that exposure limits in the US are inadequate. Exposure limits were set in the 1990s, before the plethora of scientific studies showing cancer risks at levels well below the current legal exposure limit. All of those studies are based entirely on short-term exposures, with no consideration at that time of long-term exposures. We now have an abundance of data showing just how dangerous EMF may be.

Government warnings have been issued, but according to Forbes , most of the public is unaware of such warnings. Cell phone manual warnings make clear that an overexposure problem exists—but that is to limit legal liability, and besides, who reads cell phone manuals? Furthermore, FCC regulations state that devices should be tested under normal operating conditions—yet many RF/EMF products, including cell phones and laptops, usually measure exposure when the device is held 20 centimeters (a little less than 8 inches) from the body. People place laptops on their laps and keep cell phones in receiving mode (rather than the presumably safe airplane mode) in their pockets and bras all the time. Most people hold their cell phones to their heads to talk, rather than using speakerphone or a headset.

As we noted in 2011, there have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs. But after this new study on the RF/EMF dangers to young children, concern is mounting about the growing number of children’s toys that use Wi-Fi technology—and that’s not counting the number of kids who play with tablets or carry cell phones these days.

Proximity to the Wi-Fi device seems to be the most important factor. Under international guidelines, the rate that energy is absorbed into the body from Wi-Fi radio waves—the Specific Absorption Rate (SAR)—cannot exceed two watts per kilogram when averaged over any ten grams of tissue. According to Apple, during testing, iPhone radios are set to their highest transmission levels and placed in positions that simulate use against the head, with no separation, and near the body, with 5 millimeter separation; iPads are placed in positions that simulate everyday use. Apple’s devices average 0.99 watts per kilogram. The SAR of other manufacturers’ devices vary, but are all below international guidelines; according to the Federal Communications Commission, all wireless devices sold in the US go through a formal FCC approval process to ensure that they do not exceed the maximum allowable SAR level when operating at the device’s highest possible power level.

The World Health Organization (WHO), which has established an International Electromagnetic Fields Project (IEFP) to provide information on health risks, establish research needs and support efforts to harmonize RF exposure standards, provides additional information on RF exposure and mobile phone use. WHO notes the problem of determining long-term risks:

Epidemiological research examining potential long-term risks from radiofrequency exposure has mostly looked for an association between brain tumors and mobile phone use. However, because many cancers are not detectable until many years after the interactions that led to the tumor, and since mobile phones were not widely used until the early 1990s, epidemiological studies at present can only assess those cancers that become evident within shorter time periods.

WHO notes that the largest retrospective case-control study to date on adults was called Interphone, coordinated by the International Agency for Research on Cancer (IARC). It gathered data from thirteen participating countries, and was designed to determine whether there are links between use of mobile phones and head and neck cancers in adults. The study found some indications of an increased risk of gliomas for those who reported the highest 10% of cumulative hours of cell phone use, although there was no consistent trend of increasing risk with greater duration of use. While the researchers concluded that biases and errors limit the strength of these conclusions and prevent a causal interpretation, based largely on these data, IARC has classified radiofrequency electromagnetic fields as possibly carcinogenic to humans (Group 2B), a category used when a causal association is considered credible, but when chance, bias or confounding cannot be ruled out with reasonable confidence.

As for the Wi-Fi in routers and laptops, the maximum signal strength next to a router or computer transmitter is 0.1 watts, and the power level falls off very rapidly beyond a few centimeter from the transmission points. However, the more individual transmitters (the more laptops or tablets in a room), the greater the danger. It is believed that a classroom containing twenty laptops and two routers could combine and be equivalent to the emission from a mobile phone.

Unfortunately, rather than erring on the side of caution or taking precautionary steps, the US seems to be moving in the opposite direction. The FCC has noted that equipping schools with Wi-Fi is a national priority; the agency plans to invest an additional $2 billion in broadband service for schools and libraries by the end of the year.

In our increasingly tech-intensive world, we need to do a better job of evaluating the risks of moving further and further away from nature. If you are concerned about RF/EMF exposure, consider some simple changes:

• Limit your cell phone usage. Carry it away from your body, in a purse or messenger bag, or at least carry it in airplane (non-receiving) mode, and use the speakerphone function or a wired headset for conversations. Use land lines where possible.


• Consider hardwiring your computers to the modem via Ethernet instead of using Wi-Fi (that’s what we do at the ANH-USA offices).


• Reduce your children’s access to cell phones, and limit time on tablets and other devices that have Wi-Fi.


• Opt-out of installing smart meters in your home (though this may be difficult in some states).

In response to public and governmental concern, WHO has established the International Electromagnetic Fields Project to assess the scientific evidence of possible adverse health effects from electromagnetic fields. WHO will conduct a formal risk assessment of all studied health outcomes from RF fields exposure by 2016.

Dr. Mercola, in a powerful article on RF/EMF dangers, reported an interesting suggestion from a panel of experts: EMF-free zones where children, pregnant women (or those hoping to conceive), and others sensitive to EMFs, can be protected. It’s an excellent first step for protecting the most vulnerable members of our society.

from The Alliance for Natural Health USA http://ift.tt/1JCF0oW via Aloe for Health

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Wi-Fi Especially Dangerous for Young Children—Cell Phones Too

Kids exposed to EMF radiation may develop cancer later in life, and the risk is much greater than previously thought. Should we really be all that concerned about radiation from our cell phones (which we carry with us everywhere) and our Wi-Fi (which is nearly ubiquitous these days)? The UN’s International Agency for Research on Cancer calls microwave radiation (MWR) a class 2B carcinogen, which means it possibly causes cancer in humans—it’s in the same category as lead, chloroform, gasoline fumes, and the pesticide DDT. Most of the research concerns a specific type of MWR: the radiofrequency electromagnetic fields (RF/EMF) given off by radios, televisions, microwave ovens, cell phones and Wi-Fi, and the smart meters installed in your home by the utility company. A new study published in the Journal of Microscopy and Ultrastructure says we are right to be concerned. Children are at dramatically greater risk from RF/EMF than adults because their brain tissues are more absorbent, their skulls are thinner, and their relative size is smaller. In general, the younger the child, the higher the risk, according to the study; fetuses are particularly vulnerable to MWR, which means pregnant women should take great care indeed. The study also found that adults are at a lower, but still significant, risk, echoing the findings of a 2013 case study from a team of breast cancer surgeons and pathologists who raised the possibility that nonionizing radiation from cell phone EMF exposures caused multifocal invasive breast cancer in four young women. These women, all between the ages of 21 and 39, regularly carried their smartphones directly against their breasts in their bras for up to ten hours a day, for several years. All four developed tumors in areas of their breasts immediately underlying the phones. All four had no family history of breast cancer, tested negative for BRCA1 and BRCA2, and had no other known breast cancer risks. The pathology of all four cases shows striking similarities in the tumor composition. The youngest of the group started carrying her cell phone in her bra at age 15. The Microscopy and Ultrastructure study made a particular recommendation that adolescent girls and women should never place cell phones in their bras or in hijabs (headscarves). The study noted that exposure limits in the US are inadequate. Exposure limits were set in the 1990s, before the plethora of scientific studies showing cancer risks at levels well below the current legal exposure limit. All of those studies are based entirely on short-term exposures, with no consideration at that time of long-term exposures. We now have an abundance of data showing just how dangerous EMF may be. Government warnings have been issued, but according to Forbes , most of the public is unaware of such warnings. Cell phone manual warnings make clear that an overexposure problem exists—but that is to limit legal liability, and besides, who reads cell phone manuals? Furthermore, FCC regulations state that devices should be tested under normal operating conditions—yet many RF/EMF products, including cell phones and laptops, usually measure exposure when the device is held 20 centimeters (a little less than 8 inches) from the body. People place laptops on their laps and keep cell phones in receiving mode (rather than the presumably safe airplane mode) in their pockets and bras all the time. Most people hold their cell phones to their heads to talk, rather than using speakerphone or a headset. As we noted in 2011, there have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs. But after this new study on the RF/EMF dangers to young children, concern is mounting about the growing number of children’s toys that use Wi-Fi technology—and that’s not counting the number of kids who play with tablets or carry cell phones these days. Proximity to the Wi-Fi device seems to be the most important factor. Under international guidelines, the rate that energy is absorbed into the body from Wi-Fi radio waves—the Specific Absorption Rate (SAR)—cannot exceed two watts per kilogram when averaged over any ten grams of tissue. According to Apple, during testing, iPhone radios are set to their highest transmission levels and placed in positions that simulate use against the head, with no separation, and near the body, with 5 millimeter separation; iPads are placed in positions that simulate everyday use. Apple’s devices average 0.99 watts per kilogram. The SAR of other manufacturers’ devices vary, but are all below international guidelines; according to the Federal Communications Commission, all wireless devices sold in the US go through a formal FCC approval process to ensure that they do not exceed the maximum allowable SAR level when operating at the device’s highest possible power level. The World Health Organization (WHO), which has established an International Electromagnetic Fields Project (IEFP) to provide information on health risks, establish research needs and support efforts to harmonize RF exposure standards, provides additional information on RF exposure and mobile phone use. WHO notes the problem of determining long-term risks:

Epidemiological research examining potential long-term risks from radiofrequency exposure has mostly looked for an association between brain tumors and mobile phone use. However, because many cancers are not detectable until many years after the interactions that led to the tumor, and since mobile phones were not widely used until the early 1990s, epidemiological studies at present can only assess those cancers that become evident within shorter time periods.

WHO notes that the largest retrospective case-control study to date on adults was called Interphone, coordinated by the International Agency for Research on Cancer (IARC). It gathered data from thirteen participating countries, and was designed to determine whether there are links between use of mobile phones and head and neck cancers in adults. The study found some indications of an increased risk of gliomas for those who reported the highest 10% of cumulative hours of cell phone use, although there was no consistent trend of increasing risk with greater duration of use. While the researchers concluded that biases and errors limit the strength of these conclusions and prevent a causal interpretation, based largely on these data, IARC has classified radiofrequency electromagnetic fields as possibly carcinogenic to humans (Group 2B), a category used when a causal association is considered credible, but when chance, bias or confounding cannot be ruled out with reasonable confidence. As for the Wi-Fi in routers and laptops, the maximum signal strength next to a router or computer transmitter is 0.1 watts, and the power level falls off very rapidly beyond a few centimeter from the transmission points. However, the more individual transmitters (the more laptops or tablets in a room), the greater the danger. It is believed that a classroom containing twenty laptops and two routers could combine and be equivalent to the emission from a mobile phone. Unfortunately, rather than erring on the side of caution or taking precautionary steps, the US seems to be moving in the opposite direction. The FCC has noted that equipping schools with Wi-Fi is a national priority; the agency plans to invest an additional $2 billion in broadband service for schools and libraries by the end of the year. In our increasingly tech-intensive world, we need to do a better job of evaluating the risks of moving further and further away from nature. If you are concerned about RF/EMF exposure, consider some simple changes:

• Limit your cell phone usage. Carry it away from your body, in a purse or messenger bag, or at least carry it in airplane (non-receiving) mode, and use the speakerphone function or a wired headset for conversations. Use land lines where possible.


• Consider hardwiring your computers to the modem via Ethernet instead of using Wi-Fi (that’s what we do at the ANH-USA offices).


• Reduce your children’s access to cell phones, and limit time on tablets and other devices that have Wi-Fi.


• Opt-out of installing smart meters in your home (though this may be difficult in some states).

In response to public and governmental concern, WHO has established the International Electromagnetic Fields Project to assess the scientific evidence of possible adverse health effects from electromagnetic fields. WHO will conduct a formal risk assessment of all studied health outcomes from RF fields exposure by 2016. Dr. Mercola, in a powerful article on RF/EMF dangers, reported an interesting suggestion from a panel of experts: EMF-free zones where children, pregnant women (or those hoping to conceive), and others sensitive to EMFs, can be protected. It’s an excellent first step for protecting the most vulnerable members of our society.



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Compounded Medications Even More At Risk

A new threat to compounded drugs (including bioidentical estriol for women and compounded time-release thyroid) has emerged. Action Alert!

The US Pharmacopeial Convention (USP) has released an overreaching draft proposal that may inadvertently crush many small compounding pharmacies—unless we take action. USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines (including compounded drugs), food ingredients, and dietary supplements. Since USP is considered an authoritative standard-setting body, it is very likely that these USP standards, like earlier ones, will be adopted into law.

The USP is creating new standards with “General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings .” Its stated intention is to protect healthcare workers from exposure to hazardous drugs (HDs). But many of the drugs in question are not hazardous at all. In addition, many compounding pharmacies—especially small traditional pharmacies—will be unable to implement the new standards and as a result could be forced out of business.

Here are just some of the problems with the new USP standards:

• They are not within the USP’s purview or expertise. The USP is supposed to set standards to maintain the quality of drugs and drug components. Protecting compounding and environmental workers from hazardous exposures, while an important goal, is already covered elsewhere under current law. On the federal level there are EPA and OSHA laws that ensure worker safety, and there are state laws as well. There is simply no need for these additional standards—they will lead only to duplication, confusion, and overregulation.


• There has been no assessment by the USP on the extent to which the proposed standards would jeopardize patient access to compounded medicines.


• The USP’s list of drugs considered “hazardous” is overly broad. It includes many commonly used medications such as azathioprine, carbamazepine, and clonazepam, not to mention all contraceptives and hormone replacement therapies that contain estrogen—which means bioidentical estriol is also on the list! These drugs are dispensed by pharmacists, administered by nurses or medication aides, or are self-administered by patients every day.


• The USP is relying on the National Institute for Occupational Safety and Health’s (NIOSH) list of antineoplastic and other hazardous drugs (HDs) used in healthcare settings. However, NIOSH’s own list states in multiple place that there is uncertainty about the contents of their list. They even state that “no attempt has been made to perform drug risk assessments or propose exposure limits.” NIOSH acknowledges that there is little evidence that some of these drugs are hazardous to healthcare personnel, and explains that the organization was enlisted to provide guidance to healthcare facilities, not to provide a mandate—yet the USP is using that same list in its entirety without proper review.


• Many small pharmacies and healthcare facilities will be unable to comply with the requirements.The new standards require that HDs be unpacked from their shipping container and stored in negative-pressure rooms. These have to be entirely separate from so-called non-hazardous drugs. This would require many different physical spaces, which means new construction in most cases. Most small compounding pharmacies simply cannot afford to build entirely separate rooms—in fact, a compounding pharmacy told us that the cost to build new rooms and buy the negative-pressure equipment could cost several hundred thousand dollars. Some hospitals may have more money, but they and physicians’ offices may also lack the physical space for negative-pressure areas. Furthermore, the new standards do not discuss how to handle a combination of so-called hazardous and non-hazardous drugs—which many compounders mix on a daily basis. The requirement for separate rooms should be balanced with the level of risk compounders actually face, not to mention the economic burden being placed on them.


• The impact will be far-reaching.While these standards will have the greatest impact on compounding pharmacies—small traditional compounding pharmacies in particular—they will also affect the day-to-day practices of every healthcare facility that receives, stores, compounds, and administers HDs: regular pharmacies, wholesalers, distributers, hospitals, clinics, and all long-term care and assisted facilities. In the most likely scenario, compounding pharmacies will simply stop making vital drugs that millions of Americans depend upon, while other healthcare facilities will pass the new costs on to the consumer. Once again, regulators are not showing any common sense.

The USP predates the Food Drug and Cosmetic Act (FD&C) and has influenced the development of all drug, compounding, and supplement standards in the US. However, there is a great deal of crossover between the USP and the FDA. For example, FDA staff acts as liaisons to various USP standards committees, and they can ask USP to develop or modify standards. Moreover, FDA can comment on proposed USP standards. In return, USP staff have participated in FDA advisory committees.

That’s why we feel the timing of this revision is suspicious. It comes on the heels of the FDA’s draconian implementation of the new compounding law, which also threatens to force compounders out of business, leaving drugs only available from large pharmaceutical companies producing their one-size-fits-all (and often flawed) products. There has been no inciting incident, no official call to address HDs, as a letter to USP from the International Academy of Compounding Pharmacists makes clear—in short, there is simply no logical reason why USP should suddenly want to create these new standards.

Already some insurance companies are no longer covering certain compounded medications, restricting your access to them. If the USP formally adopts this draft proposal, it will likely only be a matter of time before these new standards are incorporated into federal or state law, just as previous USP standards have been—and that may mean the end of most important compounded drugs altogether.

These new USP standards could easily be the final nail in the coffin for small, traditional compounding pharmacies:

• As we’ve reported in earlier articles, the new compounding law allows traditional compounding pharmacies to ship no more than 5% of their products out of state, while the newly created category of compounder, massive “outsourcing facilities” (which are likely owned by Big Pharma) do not have the 5% restriction. Small pharmacies are crippled right from the start. Note also how nonsensical a small percentage limitation like this is. How can pharmacies know how much 5% really is until the end of the year? By then they have violated the rule!


• These massive outsourcing facilities may have the financial resources to build the new negative-pressure rooms required by the new USP standards—something that could further impoverish small, traditional pharmacies.


• If the traditional compounding pharmacies are forced to shut down, important medications like bioidentical estriol and time-released thyroid will almost certainly disappear with them: big outsourcing facilities are allowed to compound only those medications that appear on the FDA’s yet-to-be-released “allowed” list. As regular Pulse readers will know, the FDA has attempted repeatedly to eliminate estriol, so it’s extremely likely it won’t be on the list.

We can’t stress strongly enough the importance of the small, traditional compounding pharmacies. Without them, natural health advocates will simply lose all access to some of the most important medications they rely upon.

Action Alert! The USP is accepting public comments until May 31, 2015. Tell the USP that General Chapter <800> should not be considered a mandate for healthcare facilities and compounding pharmacies, but instead should be listed in the “recommendations” section of the USP standards. Even more importantly, ask the USP to revise their standards to account for the concerns we raised above. Please send your message to USP today!

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