FDA “Compounds” Its Attack on Supplements

The FDA’s hostility toward both supplements and compounded medicine is legendary—after all, they compete with the FDA-approved drugs that pay the government’s bills. Now the agency is attacking compounded supplements. Action Alert!

A few weeks ago, we reported on an amendment designed to fix a number of the most problematic regulations arising from Congress’s Drug Quality and Security Act (DQSA). The amendment would clarify provisions governing “office use,” allowing physicians to keep certain quantities of compounded drugs on hand in their office, and also remove the cap on interstate shipments if the medication is for an individual patient. ANH-USA strongly supports this amendment, as it would ensure patient access to important compounded medications which are currently endangered.

Keep in mind that the House Appropriations Committee recently scolded the FDA for implementing the law “in a manner inconsistent with its legislative intent.” This isn’t the first time that members of Congress have made it clear that the FDA is going too far in its compounding regulations.

Despite these warnings, the FDA continues its attack on compounding. The latest meeting of the Pharmacy Compounding Advisory Committee (PCAC), which is advising the FDA as it drafts the new rules, revealed a new and serious cause for concern—this time related to what ingredients can be compounded.

At the PCAC meeting, an FDA representative said that nutritional supplements will need to be on a pre-approved list in order to be compounded, and solicited nominations from the public for the “bulk ingredients list.” Whoa—where did this come from? Where in the legislation does it say that the FDA can ban compounded supplements?

The FDA might reply that supplements can be approved. But will they be? In addition, as we reported previously, nominating a substance for the list is a herculean task, requiring mountains of data, resources, and expertise to comply with the all the arcane rules governing such submissions. We noted that smaller organizations would find it difficult or even impossible to meet the FDA’s requirements, tipping the balance in favor of large companies who would, as usual, support the FDA’s rules as a means of eliminating the competition. This includes some major drug makers who also have a foothold in the supplement market.

Does this mean that all supplements in need of compounding must go through the onerous process of being nominated—and approved—for the FDA’s bulk ingredients list? And what happens when the FDA approves one supplement but not another complementary one, so that the first supplement cannot even be used? The FDA has no clue about how supplements work together—how vitamin K2 must be taken with calcium, for example, so that calcium will go into the bones, where it’s needed, instead of into the blood, where it would be dangerous.

What’s most troubling about this latest action is that the FDA would end up punishing the most sensitive patients who need custom supplements because their bodies’ biology or genetics require it. Why deny these patients important supplements and medications?

We are working with key members of Congress to direct two pointed questions to the FDA:

1. By what legislative authority would you prevent supplements that are not on your pre-approved bulk ingredient list from being compounded?
2. By what authority would you exclude compounded supplements from your pre-approved bulk ingredients list when they are prescribed by a physician?

Action Alert! Tell the FDA to answer our questions about this latest attack on compounding. Please send your message immediately.

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Updated “DARK Act” Will Block States from Banning GE Crops

Rep. Mike Pompeo’s voluntary GMO labeling bill has been amended to include another brazen giveaway to Big Food and the biotech industries. Action Alert!

We’ve been closely monitoring the progress of the bill introduced by Rep. Pompeo (R-KS) and backed by industry. It’s titled, deceptively, the “Safe and Accurate Food Labeling Act of 2015”—and the news hasn’t been good. A few weeks ago, we reported that a Senate version of Pompeo’s bill was in the works while the House bill continued to gain co-sponsors and bipartisan support.

Worse, a new draft of the Pompeo bill doubles down in pandering to the Big Food and biotech industries. In this revision, states and localities would be prevented from banning GMO crops. That’s right—states would no longer have any oversight over genetically engineered crops!

In addition, this updated bill would preempt any state laws mandating the labeling of foods containing GM ingredients, which has prompted pro-labeling advocates to call Pompeo’s bill the “Deny Americans’ Right to Know Act”—the DARK Act. More than seventy bills have been introduced in over thirty states to require GMO labeling, and three states (ME, VT, and CT) have, with the help of ANH-USA’s legal team, passed mandatory GMO labeling laws. But all that would be nullified if this bill becomes law. We suspect that this revision directly results from recent developments in Maui County, Hawaii, and Jackson County, Oregon. Both counties passed measures (a ballot initiative in Maui and an ordinance in Jackson) to ban the local cultivation of genetically engineered crops. Both measures are being challenged in court by Big Food. If Pompeo’s bill becomes law, decisions to uphold the bans would be moot: the language added to the most recent DARK Act draft would preempt local, democratic efforts to protect local farmers and ensure consumer health and safety.

In the past, we’ve exposed biotech’s pro-GMO talking points as deceptions, lies, and falsehoods on our GMO Fact Check page. GMOs will not feed the world or decrease pesticide use, nor are they proven to be safe for human consumption. But the fact is that, as far as policy discussions go, these arguments are utterly beside the point. Consumers have consistently and overwhelmingly demonstrated that they want to know what’s in the food they’re buying, and supporters of Pompeo’s DARK Act want to withhold this information from consumers.

The fact that Rep. Pompeo’s legislation not only seeks to preempt state labeling efforts but also to block local efforts to ban the cultivation of GE crops makes his real goals crystal clear—to protect the bottom line of agribusinesses, which have contributed over $100,000 to Rep. Pompeo.

Over the last few weeks, the bill has been continuing to gain momentum. Hearings on the measure have been held in the Energy and Commerce and the Agricultural committees, and a “mark-up” session is expected to happen soon, bringing the bill even closer to a vote.

Action Alert! Write to your legislators in Congress and urge them not to support the new discussion draft of the DARK Act, which would block states from taking action to protect residents’ health and safety. Please send your message immediately.

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Dentists Take Advantage of Children on Medicaid

They’re raking in hundreds of millions of dollars across multiple states.

Over the past couple of years, the Office of the Inspector General (OIG), which is part of the Department of Health and Human Services, has been looking into a colossal scandal across the country. Thousands of dentists have been implicated in a series of reports by the OIG. The charge? Highly questionable Medicaid reimbursement bills for excessive and even needless services given to low-income children, often to their great harm.

The latest report from OIG looks at California. It identified 335 providers with questionable billing practices who collected $117.5 million from Medicaid for pediatric dental services in 2012 alone. Half of these dentists worked for dental chains, suggesting an organized scam. They are, in fact, gaming Medicaid.

The OIS analysis found that some general dentists were providing an absurd—and frankly impossible—number of services per day compared to the average in California. Twenty-four services per day is average in the state; two dentists averaged more than 500 services per day; one dentist provided 1,658 services in a single day!

It gets worse. OIS uncovered evidence suggesting that over 100 general dentists were either billing for procedures they didn’t do or were performing unnecessary dental procedures:

• One hundred and eight general dentists provided stainless steel crowns to a suspiciously high proportion of Medicaid covered children (18% of children on Medicaid compared to a 5% average).
• Ninety-eight dentists provided pulpotomies to a high percentage of Medicaid children (18% compared to an average of 5%). A pulpotomy, often referred to as a “baby root canal,” involves the removal of a part of the tooth.
• Eleven general dentists extracted teeth from a very high percentage of their young Medicaid patients (44% of children on Medicaid against an average of 12%).

In one case, a dentist performed nineteen root canals—in addition to twenty-one other services!—on a single five-year-old child. Most children around this age have only twenty teeth.

The report “raises concerns about the quality of care and whether children treated by these dentists were harmed by these procedures.” Indeed! It is unconscionable to think that dentists around the country are performing excessive, needless procedures on children. To make matters even worse, there’s good evidence to suggest that root canals—despite the assurance of safety from conventional dentists—spread harmful bacteria throughout the body and can contribute to other diseases. Imagine the impact these procedures could have on a young immune system!

These are only the dentists who got caught. How many others are doing this? What about pediatricians treating children on Medicaid? One can only imagine the depths of this type of malfeasance.

Besides these Medicaid cases, there are also problems with Medicare, the program for seniors. Over the years, Medicare fraud has also cost taxpayers hundreds of millions of dollars: in 2012, for example, federal authorities arrested 107 healthcare providers in several cities and charged them with overbilling Medicare to the tune of $452 million. Just as dental chains were especially implicated in OIS investigation, Medicare fraud seems to be less a problem of individual practitioners and more of organized theft schemes involving dozens of doctors, nurses, and healthcare and medical supply companies.

As demand for care outstrips the supply of doctors willing to treat Medicare and Medicaid patients, patients are losing access to providers—and of course it’s the neediest patients who are affected. This well-documented problem will only worsen if such fraud continues unchallenged.

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Action Alert: FDA Attack on Compounded Supplements

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FDA “Compounds” Its Attack on Supplements

The FDA’s hostility toward both supplements and compounded medicine is legendary—after all, they compete with the FDA-approved drugs that pay the government’s bills. Now the agency is attacking compounded supplements. Action Alert!

A few weeks ago, we reported on an amendment designed to fix a number of the most problematic regulations arising from Congress’s Drug Quality and Security Act (DQSA). The amendment would clarify provisions governing “office use,” allowing physicians to keep certain quantities of compounded drugs on hand in their office, and also remove the cap on interstate shipments if the medication is for an individual patient. ANH-USA strongly supports this amendment, as it would ensure patient access to important compounded medications which are currently endangered.

Keep in mind that the House Appropriations Committee recently scolded the FDA for implementing the law “in a manner inconsistent with its legislative intent.” This isn’t the first time that members of Congress have made it clear that the FDA is going too far in its compounding regulations.

Despite these warnings, the FDA continues its attack on compounding. The latest meeting of the Pharmacy Compounding Advisory Committee (PCAC), which is advising the FDA as it drafts the new rules, revealed a new and serious cause for concern—this time related to what ingredients can be compounded.

At the PCAC meeting, an FDA representative said that nutritional supplements will need to be on a pre-approved list in order to be compounded, and solicited nominations from the public for the “bulk ingredients list.” Whoa—where did this come from? Where in the legislation does it say that the FDA can ban compounded supplements?

The FDA might reply that supplements can be approved. But will they be? In addition, as we reported previously, nominating a substance for the list is a herculean task, requiring mountains of data, resources, and expertise to comply with the all the arcane rules governing such submissions. We noted that smaller organizations would find it difficult or even impossible to meet the FDA’s requirements, tipping the balance in favor of large companies who would, as usual, support the FDA’s rules as a means of eliminating the competition. This includes some major drug makers who also have a foothold in the supplement market.

Does this mean that all supplements in need of compounding must go through the onerous process of being nominated—and approved—for the FDA’s bulk ingredients list? And what happens when the FDA approves one supplement but not another complementary one, so that the first supplement cannot even be used? The FDA has no clue about how supplements work together—how vitamin K2 must be taken with calcium, for example, so that calcium will go into the bones, where it’s needed, instead of into the blood, where it would be dangerous.

What’s most troubling about this latest action is that the FDA would end up punishing the most sensitive patients who need custom supplements because their bodies’ biology or genetics require it. Why deny these patients important supplements and medications?

We are working with key members of Congress to direct two pointed questions to the FDA:

1. By what legislative authority would you prevent supplements that are not on your pre-approved bulk ingredient list from being compounded?
2. By what authority would you exclude compounded supplements from your pre-approved bulk ingredients list when they are prescribed by a physician?

Action Alert! Tell the FDA to answer our questions about this latest attack on compounding. Please send your message immediately.

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Updated “DARK Act” Will Block States from Banning GE Crops

Rep. Mike Pompeo’s voluntary GMO labeling bill has been amended to include another brazen giveaway to Big Food and the biotech industries. Action Alert!

We’ve been closely monitoring the progress of the bill introduced by Rep. Pompeo (R-KS) and backed by industry. It’s titled, deceptively, the “Safe and Accurate Food Labeling Act of 2015”—and the news hasn’t been good. A few weeks ago, we reported that a Senate version of Pompeo’s bill was in the works while the House bill continued to gain co-sponsors and bipartisan support.

Worse, a new draft of the Pompeo bill doubles down in pandering to the Big Food and biotech industries. In this revision, states and localities would be prevented from banning GMO crops. That’s right—states would no longer have any oversight over genetically engineered crops!

In addition, this updated bill would preempt any state laws mandating the labeling of foods containing GM ingredients, which has prompted pro-labeling advocates to call Pompeo’s bill the “Deny Americans’ Right to Know Act”—the DARK Act. More than seventy bills have been introduced in over thirty states to require GMO labeling, and three states (ME, VT, and CT) have, with the help of ANH-USA’s legal team, passed mandatory GMO labeling laws. But all that would be nullified if this bill becomes law. We suspect that this revision directly results from recent developments in Maui County, Hawaii, and Jackson County, Oregon. Both counties passed measures (a ballot initiative in Maui and an ordinance in Jackson) to ban the local cultivation of genetically engineered crops. Both measures are being challenged in court by Big Food. If Pompeo’s bill becomes law, decisions to uphold the bans would be moot: the language added to the most recent DARK Act draft would preempt local, democratic efforts to protect local farmers and ensure consumer health and safety.

In the past, we’ve exposed biotech’s pro-GMO talking points as deceptions, lies, and falsehoods on our GMO Fact Check page. GMOs will not feed the world or decrease pesticide use, nor are they proven to be safe for human consumption. But the fact is that, as far as policy discussions go, these arguments are utterly beside the point. Consumers have consistently and overwhelmingly demonstrated that they want to know what’s in the food they’re buying, and supporters of Pompeo’s DARK Act want to withhold this information from consumers.

The fact that Rep. Pompeo’s legislation not only seeks to preempt state labeling efforts but also to block local efforts to ban the cultivation of GE crops makes his real goals crystal clear—to protect the bottom line of agribusinesses, which have contributed over $100,000 to Rep. Pompeo.

Over the last few weeks, the bill has been continuing to gain momentum. Hearings on the measure have been held in the Energy and Commerce and the Agricultural committees, and a “mark-up” session is expected to happen soon, bringing the bill even closer to a vote.

Action Alert! Write to your legislators in Congress and urge them not to support the new discussion draft of the DARK Act, which would block states from taking action to protect residents’ health and safety. Please send your message immediately.

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Dentists Take Advantage of Children on Medicaid

They’re raking in hundreds of millions of dollars across multiple states.

Over the past couple of years, the Office of the Inspector General (OIG), which is part of the Department of Health and Human Services, has been looking into a colossal scandal across the country. Thousands of dentists have been implicated in a series of reports by the OIG. The charge? Highly questionable Medicaid reimbursement bills for excessive and even needless services given to low-income children, often to their great harm.

The latest report from OIG looks at California. It identified 335 providers with questionable billing practices who collected $117.5 million from Medicaid for pediatric dental services in 2012 alone. Half of these dentists worked for dental chains, suggesting an organized scam. They are, in fact, gaming Medicaid.

The OIS analysis found that some general dentists were providing an absurd—and frankly impossible—number of services per day compared to the average in California. Twenty-four services per day is average in the state; two dentists averaged more than 500 services per day; one dentist provided 1,658 services in a single day!

It gets worse. OIS uncovered evidence suggesting that over 100 general dentists were either billing for procedures they didn’t do or were performing unnecessary dental procedures:

• One hundred and eight general dentists provided stainless steel crowns to a suspiciously high proportion of Medicaid covered children (18% of children on Medicaid compared to a 5% average).
• Ninety-eight dentists provided pulpotomies to a high percentage of Medicaid children (18% compared to an average of 5%). A pulpotomy, often referred to as a “baby root canal,” involves the removal of a part of the tooth.
• Eleven general dentists extracted teeth from a very high percentage of their young Medicaid patients (44% of children on Medicaid against an average of 12%).

In one case, a dentist performed nineteen root canals—in addition to twenty-one other services!—on a single five-year-old child. Most children around this age have only twenty teeth.

The report “raises concerns about the quality of care and whether children treated by these dentists were harmed by these procedures.” Indeed! It is unconscionable to think that dentists around the country are performing excessive, needless procedures on children. To make matters even worse, there’s good evidence to suggest that root canals—despite the assurance of safety from conventional dentists—spread harmful bacteria throughout the body and can contribute to other diseases. Imagine the impact these procedures could have on a young immune system!

These are only the dentists who got caught. How many others are doing this? What about pediatricians treating children on Medicaid? One can only imagine the depths of this type of malfeasance.

Besides these Medicaid cases, there are also problems with Medicare, the program for seniors. Over the years, Medicare fraud has also cost taxpayers hundreds of millions of dollars: in 2012, for example, federal authorities arrested 107 healthcare providers in several cities and charged them with overbilling Medicare to the tune of $452 million. Just as dental chains were especially implicated in OIS investigation, Medicare fraud seems to be less a problem of individual practitioners and more of organized theft schemes involving dozens of doctors, nurses, and healthcare and medical supply companies.

As demand for care outstrips the supply of doctors willing to treat Medicare and Medicaid patients, patients are losing access to providers—and of course it’s the neediest patients who are affected. This well-documented problem will only worsen if such fraud continues unchallenged.

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Action Alert: FDA Attack on Compounded Supplements

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ConsumerLab.com Comes Out Firing at ANH-USA

Yet the company still fails to answer the most serious questions we’ve raised. Why is CL continuing to avoid them? Action Alert!

Over the last few years, we’ve raised numerous concerns about the business practices of ConsumerLab.com (CL), an organization that purports to help consumers identify the highest quality dietary supplements. CL responded to our articles with a letter demanding we retract those articles—which we refused to do—and attacked ANH-USA on its website in an effort to “correct” what CL feels is “misinformation” about its business. In 2014 we sent a letter to CL asking eight very pointed questions about their business practices. We still haven’t received a response to our questions. Surely two years is long enough for the company to respond?

CL provides two main services, the Quality Certification Program and the Product Review Program.

• The Quality Certification Program is a voluntary service for supplement companies to pay to have their products tested by CL. Here’s our understanding of how it works: companies paying the fee are guaranteed that if one of their products passes the testing under the Quality Certification Program, it gets listed on the site and may carry the CL Seal of Approval—and if it fails the testing, that product at that time will not be identified to CL’s members or the public because the results are “proprietary to the manufacturer”!
• Companies that do not agree to pay for the Quality Certification Program risk having their products tested anyway through the firm’s Product Review Program, where CL reviews products for its dues-paying members. If a product fails the test, the failure will be published on CL’s website for its members and potentially in the media, with complete details for sale in CL’s Product Review Technical Reports.

This arrangement sounds to us like, “Pay up, and you won’t have to worry about the results. Don’t pay up, and you may be exposed to bad publicity.”

Our three biggest issues, which we raised in our letter to CL:

1. We asked, “Is it true that if a company does not pay to have a product tested through CL’s Quality Certification Program, it risks having that product tested through CL’s Product Reviews? And is it true that if a product fails a Product Review, its failure will be publicized in CL’s member reports?” CL said, “We do not publicize a product’s failure on our site”—quite an astonishing statement given that CL demonstrably does make the details about product failures available for sale through their website. According to the “Answers” page of CL’s website, the identities of products that fail are published “exclusively for [CL’s] members and subscribers after signing in to the ConsumerLab.com website.” Yet this members-only information has been picked up in national media stories. Has CL published this information or used it effectively to “hold up” those who fail to pay the fee for its Quality Certification Program? You can decide for yourself.
2. We also asked, “Is it true that if a company pays to have a product tested through CL’s Quality Certification Program and its product fails, those results will be hidden from CL’s member reports on the grounds that those tests are ‘proprietary to the manufacturer’?” As a follow up question, we asked, “How does withholding information from the public about failing products ‘help consumers and professionals identify high quality products’?” We still haven’t seen any response from CL on these matters, which seem to us to be vital concerns.
3. We asked CL about the quality standards they use to test products which, they boast, are better than the current good manufacturing practices (cGMPs) needed to comply with FDA regulations. We asked them to provide evidence to demonstrate that their quality standards/criteria are generally accepted in the scientific community, sufficient to determine definitively a product’s quality, and appropriate for each product they evaluate.

Here’s an example of how CL’s handling of this third issue is dramatically at variance with standard practices: ANH-USA disputed CL’s claim that a product failed because it did not adhere to the US Pharmacopeia’s (USP) standard of a thirty-minute disintegration time. We noted that one company established its own disintegration time of sixty minutes for relevant products, which met with FDA’s approval. This was deemed a “false” statement by CL, which contended that

If a product does not comply with the USP standard, the manufacturer must indicate this on the label of the product….The [multivitamin product]which was Not Approved by [CL]…provides no indication on its label that it does not meet the USP requirement nor that [the company]applies its own standard.

In our reading of the law, CL is simply incorrect. USP’s own website states that the organization’s standards are voluntary. Nowhere does it say—in either FDA’s cGMP guidelines, or in DSHEA, the landmark Dietary Supplement Health and Education Act of 1994—that there is a requirement to note a difference from USP disintegration times on the product’s label. This makes point number one above even more egregious: companies that don’t pay the fee to have their product tested risk having that product tested anyway—by questionable standards.

To be clear: as a consumer organization (and no, CL, we are not a front for industry, as your website implies), our issue with CL is not that they make product failures known to their members, but that there is an implied pressure on companies to voluntarily pay CL’s fee or else risk having products tested anyway (using questionable standards at undisclosed labs), and then having any failures made known to their members—or broadcast even more widely.

The three points above highlight the fact that on major, substantive issues regarding their business, CL refuses to respond directly to legitimate questions and instead appears to attempt to create a smokescreen by responding to different charges—or by creating red herrings, leveling charges of their own against ANH-USA.

You can find our tips for purchasing high-quality supplements here. You can also visit our Supplement Fact Check page to get the latest news on supplements.

Action Alert! Write to your state’s attorney general and the FTC and ask them to investigate the business practices of ConsumerLab.com. Please send your message immediately.

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Will Big Food Control Nutrition “Science?”

A new report details how Big Food appears to have captured yet another key nutrition group, the American Society of Nutrition. Action Alert!

You may remember that a few weeks back we reported on the Academy of Nutrition and Dietetics’ (AND) ill-fated partnership with Kraft Foods. Kraft was permitted to place the AND’s “Kids Eat Right” logo on their Kraft Singles synthetic “cheese product.” After the story broke, AND backpedaled.

This week saw the release of another report, this time exposing the ties between the American Society of Nutrition (ASN)—whose membership includes some of the nation’s leading nutrition scientists and researchers—and junk food giants like Pepsi, Coca-Cola, Nestlé, Monsanto, McDonald’s, and Mars.

Among the report’s findings:

• Of the thirty-four scientific sessions at ASN’s annual meeting, six were financially supported by PepsiCo.
• The International Life Sciences Institute (a front group for Big Food and Big Pharma) sponsored a session on low-calorie sweeteners. Speakers included a scientific consultant for Ajinomoto, which produces aspartame.
• The Grocery Manufacturers Association, a lobbying group for the food and beverage industries, sponsored a symposium on sodium intake, which referred to “putative health concerns.”
• For $35,000, junk food companies can sponsor a hospitality suite at the annual meeting, where corporate executives socialize with nutrition researchers.
• Official spokespeople for ASN reportedly have ties to Coca-Cola, McDonald’s, the American Beverage Association, General Mills, and Cadbury Schweppes.
• ASN published an eighteen-page defense of processed food that appears to consist of numerous talking points for the junk food industry, such as this one: “There are no differences between the processing of foods at home or at a factory.” Parents who work hard to make meals from scratch for their children deserve better than this.
• ASN opposes an FDA-proposed policy to include added sugars on the Nutrition Facts panel, at a time when excessive sugar consumption is causing a national public health epidemic.

Despite these well-documented ties to Big Food, ASN plays an active role in public policy formation. Just when the federal government was drafting its update of the Dietary Guidelines for Americans, ASN published a report revealingly entitled “Processed Foods: Contributions to Nutrition.” It seems to us that ASN plays a useful role—but only for junk food companies looking to influence government nutrition policies.

Because it purports to be a bastion of science-based information about nutrition, ASN also influences what nutritionists and the general public consider to be “good nutrition.” The findings of this week’s exposé should be enough to give all of us pause when considering the “scientific” information put out by ASN.

The main takeaway, then, is this: ASN is actively promoting policy decisions and disseminating information that line the coffers of its Big Food patrons. Until ASN severs these ties with the junk food industry, Americans should look elsewhere for nutrition advice.

Action Alert! Please write to the American Society for Nutrition and tell them this kind of pandering to the junk food industry is unworthy of their stated mission of “bringing together the world’s top researchers, clinical nutritionists, and industry to advance our knowledge and application of nutrition.” Ask them to stay truly independent and focus on the science of good nutrition, and stop being a mouthpiece for the processed junk food industry. Please send your message immediately.

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ANH-USA Takes the Initiative against Monopolistic Dietetics Boards

With your help, we can stop them from gagging free speech about nutrition.

ANH-USA has identified seventeen states with the most monopolistic scope-of-practice laws, and has sent letters to those states’ dietetic boards, their attorneys general, and key policymakers warning them that they are vulnerable to federal felony prosecution and civil damages under antitrust law and the First Amendment if they attempt to enforce their state’s dietetics practice laws.

Regular readers will remember our coverage of the US Supreme Court’s decision against the North Carolina Dental Board, which ruled the dental board violated antitrust laws because it did not have proper state supervision.

This ruling followed a qualified victory for Paleo-blogger Steve Cooksey. The North Carolina Board of Nutrition and Dietetics sent Cooksey a warning letter because he was offering nutritional advice about the Paleo diet at no charge on his blog—but without a board-issued license. A legal battle ensued after the Institute for Justice took up Cooksey’s case, culminating in a settlement that affirmed Cooksey’s First Amendment right to post general nutrition advice on his blog.

The main culprit behind the establishment of monopolistic state nutrition and dietetics boards is, of course, the Academy of Nutrition and Dietetics (AND). They’ve been at this for quite a while. As we’ve argued before, the AND—the trade association for Registered Dietitians (RDs)—has made it a priority to pass, in as many states as possible, “scope-of-practice” laws whereby only RDs can offer nutrition services. This, of course, explicitly excludes other nutrition professionals who are often better educated, more experienced, and better qualified than RDs. For example, a PhD in nutrition may be told he or she may not legally offer nutrition advice, while a college-educated member of the AND can.

To be clear, it’s perfectly legitimate for RDs to want to protect the term “Registered Dietitian” as a means of informing consumers of their particular professional training. At the same time, we believe in a competitive and open market for nutrition professionals. Consumers and payers (including hospitals and Medicare) should be able to decide what credentials, education, and experience they want in a nutrition provider. We advise state dietetic boards to voluntarily restrict enforcement to title protection alone—essentially limiting the use of certain specific titles like “Licensed Dietician” or “Registered Dietician.”

A free and open market for nutrition professionals is especially important given the well-documented ties between the AND and Big Food companies. (See our companion piece in this week’s Pulse edition to learn more about ties between another group of nutrition professionals—the American Society for Nutrition—and Big Food). When so-called nutrition “experts” take money from the likes of Coca-Cola, Kraft Foods, and other junk food giants, consumers must have access to other nutrition professionals. The AND’s relationship with Big Food is so cozy and entrenched that the AND allows its members, who are required to take continuing education courses to maintain their title, to fulfill this requirement by taking courses developed and offered for free from Big Food companies. Who better to teach dieticians and nutritionists about sugar than Coca-Cola? Who indeed!

If you know of a practitioner who has been the target of inappropriate actions by a state nutrition/dietetics board, please contact submit a story on our website!

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ConsumerLab.com Comes Out Firing at ANH-USA

Yet the company still fails to answer the most serious questions we’ve raised. Why is CL continuing to avoid them? Action Alert!

Over the last few years, we’ve raised numerous concerns about the business practices of ConsumerLab.com (CL), an organization that purports to help consumers identify the highest quality dietary supplements. CL responded to our articles with a letter demanding we retract those articles—which we refused to do—and attacked ANH-USA on its website in an effort to “correct” what CL feels is “misinformation” about its business. In 2014 we sent a letter to CL asking eight very pointed questions about their business practices. We still haven’t received a response to our questions. Surely two years is long enough for the company to respond?

CL provides two main services, the Quality Certification Program and the Product Review Program.

• The Quality Certification Program is a voluntary service for supplement companies to pay to have their products tested by CL. Here’s our understanding of how it works: companies paying the fee are guaranteed that if one of their products passes the testing under the Quality Certification Program, it gets listed on the site and may carry the CL Seal of Approval—and if it fails the testing, that product at that time will not be identified to CL’s members or the public because the results are “proprietary to the manufacturer”!
• Companies that do not agree to pay for the Quality Certification Program risk having their products tested anyway through the firm’s Product Review Program, where CL reviews products for its dues-paying members. If a product fails the test, the failure will be published on CL’s website for its members and potentially in the media, with complete details for sale in CL’s Product Review Technical Reports.

This arrangement sounds to us like, “Pay up, and you won’t have to worry about the results. Don’t pay up, and you may be exposed to bad publicity.”

Our three biggest issues, which we raised in our letter to CL:

1. We asked, “Is it true that if a company does not pay to have a product tested through CL’s Quality Certification Program, it risks having that product tested through CL’s Product Reviews? And is it true that if a product fails a Product Review, its failure will be publicized in CL’s member reports?” CL said, “We do not publicize a product’s failure on our site”—quite an astonishing statement given that CL demonstrably does make the details about product failures available for sale through their website. According to the “Answers” page of CL’s website, the identities of products that fail are published “exclusively for [CL’s] members and subscribers after signing in to the ConsumerLab.com website.” Yet this members-only information has been picked up in national media stories. Has CL published this information or used it effectively to “hold up” those who fail to pay the fee for its Quality Certification Program? You can decide for yourself.
2. We also asked, “Is it true that if a company pays to have a product tested through CL’s Quality Certification Program and its product fails, those results will be hidden from CL’s member reports on the grounds that those tests are ‘proprietary to the manufacturer’?” As a follow up question, we asked, “How does withholding information from the public about failing products ‘help consumers and professionals identify high quality products’?” We still haven’t seen any response from CL on these matters, which seem to us to be vital concerns.
3. We asked CL about the quality standards they use to test products which, they boast, are better than the current good manufacturing practices (cGMPs) needed to comply with FDA regulations. We asked them to provide evidence to demonstrate that their quality standards/criteria are generally accepted in the scientific community, sufficient to determine definitively a product’s quality, and appropriate for each product they evaluate.

Here’s an example of how CL’s handling of this third issue is dramatically at variance with standard practices: ANH-USA disputed CL’s claim that a product failed because it did not adhere to the US Pharmacopeia’s (USP) standard of a thirty-minute disintegration time. We noted that one company established its own disintegration time of sixty minutes for relevant products, which met with FDA’s approval. This was deemed a “false” statement by CL, which contended that

If a product does not comply with the USP standard, the manufacturer must indicate this on the label of the product….The [multivitamin product]which was Not Approved by [CL]…provides no indication on its label that it does not meet the USP requirement nor that [the company]applies its own standard.

In our reading of the law, CL is simply incorrect. USP’s own website states that the organization’s standards are voluntary. Nowhere does it say—in either FDA’s cGMP guidelines, or in DSHEA, the landmark Dietary Supplement Health and Education Act of 1994—that there is a requirement to note a difference from USP disintegration times on the product’s label. This makes point number one above even more egregious: companies that don’t pay the fee to have their product tested risk having that product tested anyway—by questionable standards.

To be clear: as a consumer organization (and no, CL, we are not a front for industry, as your website implies), our issue with CL is not that they make product failures known to their members, but that there is an implied pressure on companies to voluntarily pay CL’s fee or else risk having products tested anyway (using questionable standards at undisclosed labs), and then having any failures made known to their members—or broadcast even more widely.

The three points above highlight the fact that on major, substantive issues regarding their business, CL refuses to respond directly to legitimate questions and instead appears to attempt to create a smokescreen by responding to different charges—or by creating red herrings, leveling charges of their own against ANH-USA.

You can find our tips for purchasing high-quality supplements here. You can also visit our Supplement Fact Check page to get the latest news on supplements.

Action Alert! Write to your state’s attorney general and the FTC and ask them to investigate the business practices of ConsumerLab.com. Please send your message immediately.

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Will Big Food Control Nutrition “Science?”

A new report details how Big Food appears to have captured yet another key nutrition group, the American Society of Nutrition. Action Alert!

You may remember that a few weeks back we reported on the Academy of Nutrition and Dietetics’ (AND) ill-fated partnership with Kraft Foods. Kraft was permitted to place the AND’s “Kids Eat Right” logo on their Kraft Singles synthetic “cheese product.” After the story broke, AND backpedaled.

This week saw the release of another report, this time exposing the ties between the American Society of Nutrition (ASN)—whose membership includes some of the nation’s leading nutrition scientists and researchers—and junk food giants like Pepsi, Coca-Cola, Nestlé, Monsanto, McDonald’s, and Mars.

Among the report’s findings:

• Of the thirty-four scientific sessions at ASN’s annual meeting, six were financially supported by PepsiCo.
• The International Life Sciences Institute (a front group for Big Food and Big Pharma) sponsored a session on low-calorie sweeteners. Speakers included a scientific consultant for Ajinomoto, which produces aspartame.
• The Grocery Manufacturers Association, a lobbying group for the food and beverage industries, sponsored a symposium on sodium intake, which referred to “putative health concerns.”
• For $35,000, junk food companies can sponsor a hospitality suite at the annual meeting, where corporate executives socialize with nutrition researchers.
• Official spokespeople for ASN reportedly have ties to Coca-Cola, McDonald’s, the American Beverage Association, General Mills, and Cadbury Schweppes.
• ASN published an eighteen-page defense of processed food that appears to consist of numerous talking points for the junk food industry, such as this one: “There are no differences between the processing of foods at home or at a factory.” Parents who work hard to make meals from scratch for their children deserve better than this.
• ASN opposes an FDA-proposed policy to include added sugars on the Nutrition Facts panel, at a time when excessive sugar consumption is causing a national public health epidemic.

Despite these well-documented ties to Big Food, ASN plays an active role in public policy formation. Just when the federal government was drafting its update of the Dietary Guidelines for Americans, ASN published a report revealingly entitled “Processed Foods: Contributions to Nutrition.” It seems to us that ASN plays a useful role—but only for junk food companies looking to influence government nutrition policies.

Because it purports to be a bastion of science-based information about nutrition, ASN also influences what nutritionists and the general public consider to be “good nutrition.” The findings of this week’s exposé should be enough to give all of us pause when considering the “scientific” information put out by ASN.

The main takeaway, then, is this: ASN is actively promoting policy decisions and disseminating information that line the coffers of its Big Food patrons. Until ASN severs these ties with the junk food industry, Americans should look elsewhere for nutrition advice.

Action Alert! Please write to the American Society for Nutrition and tell them this kind of pandering to the junk food industry is unworthy of their stated mission of “bringing together the world’s top researchers, clinical nutritionists, and industry to advance our knowledge and application of nutrition.” Ask them to stay truly independent and focus on the science of good nutrition, and stop being a mouthpiece for the processed junk food industry. Please send your message immediately.

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ANH-USA Takes the Initiative against Monopolistic Dietetics Boards

With your help, we can stop them from gagging free speech about nutrition.

ANH-USA has identified seventeen states with the most monopolistic scope-of-practice laws, and has sent letters to those states’ dietetic boards, their attorneys general, and key policymakers warning them that they are vulnerable to federal felony prosecution and civil damages under antitrust law and the First Amendment if they attempt to enforce their state’s dietetics practice laws.

Regular readers will remember our coverage of the US Supreme Court’s decision against the North Carolina Dental Board, which ruled the dental board violated antitrust laws because it did not have proper state supervision.

This ruling followed a qualified victory for Paleo-blogger Steve Cooksey. The North Carolina Board of Nutrition and Dietetics sent Cooksey a warning letter because he was offering nutritional advice about the Paleo diet at no charge on his blog—but without a board-issued license. A legal battle ensued after the Institute for Justice took up Cooksey’s case, culminating in a settlement that affirmed Cooksey’s First Amendment right to post general nutrition advice on his blog.

The main culprit behind the establishment of monopolistic state nutrition and dietetics boards is, of course, the Academy of Nutrition and Dietetics (AND). They’ve been at this for quite a while. As we’ve argued before, the AND—the trade association for Registered Dietitians (RDs)—has made it a priority to pass, in as many states as possible, “scope-of-practice” laws whereby only RDs can offer nutrition services. This, of course, explicitly excludes other nutrition professionals who are often better educated, more experienced, and better qualified than RDs. For example, a PhD in nutrition may be told he or she may not legally offer nutrition advice, while a college-educated member of the AND can.

To be clear, it’s perfectly legitimate for RDs to want to protect the term “Registered Dietitian” as a means of informing consumers of their particular professional training. At the same time, we believe in a competitive and open market for nutrition professionals. Consumers and payers (including hospitals and Medicare) should be able to decide what credentials, education, and experience they want in a nutrition provider. We advise state dietetic boards to voluntarily restrict enforcement to title protection alone—essentially limiting the use of certain specific titles like “Licensed Dietician” or “Registered Dietician.”

A free and open market for nutrition professionals is especially important given the well-documented ties between the AND and Big Food companies. (See our companion piece in this week’s Pulse edition to learn more about ties between another group of nutrition professionals—the American Society for Nutrition—and Big Food). When so-called nutrition “experts” take money from the likes of Coca-Cola, Kraft Foods, and other junk food giants, consumers must have access to other nutrition professionals. The AND’s relationship with Big Food is so cozy and entrenched that the AND allows its members, who are required to take continuing education courses to maintain their title, to fulfill this requirement by taking courses developed and offered for free from Big Food companies. Who better to teach dieticians and nutritionists about sugar than Coca-Cola? Who indeed!

If you know of a practitioner who has been the target of inappropriate actions by a state nutrition/dietetics board, please contact submit a story on our website!

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Action Alert! Tell ASN to Stop Pandering to Big Food

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Action Alert! Tell ASN to Stop Pandering to Big Food

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New Amendment May Help Save Compounded Drugs

Please help us get Sen. David Vitter’s critical amendment passed! Action Alert!

As you know from our continuing coverage, the FDA has been issuing rules to implement the Drug Quality and Security Act (DQSA). This legislation was passed by Congress in 2013 in response to a meningitis outbreak in 2012 involving a single bad actor—a compounding facility in Massachusetts about whom the FDA had received numerous complaints (though the agency took no action other than sending a warning letter to the facility).

Panicked legislators nearly destroyed compounding as an alternative to conventional drugs—something that would eliminate competition for the biggest drug companies, which is why the DQSA seems to have garnered support from Big Pharma allies at the FDA. We were able to amend the law and help save compounding, but some very bad provisions remain. As a result, ANH-USA has been closely monitoring the FDA as it releases drafts of its new rules and guidance documents pertaining to this law.

Compounding, in many cases, is the only way for consumers to access a number of important natural medicines, or to take those medicines in more natural ways. For example, a number of hormones should not be taken orally, but only transdermally. Drug companies and the FDA simply ignore this.

Compounding is important for other reasons as well. In particular, it allows doctors and pharmacists to create medications that are the exact strength, dosage, and ingredient mix best suited to treat an individual patient. Perhaps the medication needs to be gluten free or in lower dosages. We are all different; medicine should never be one-size-fits-all.

We have two main points of contention with the new FDA rules on compounding:

Office Use

“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 the compounded drugs on hand. This enables doctors to provide immediate relief to ailing patients who come into their office, or to have a ready supply for patients whom they have a long history of treating.

For decades, the regulation of “office use” was left up to state pharmacy boards, and most state boards allowed physicians to keep a supply of compounded drugs on hand without prescriptions, recognizing that patients’ well-being depended on it. This changed with the passage of the DQSA.

Congress’s intent was to give the FDA clearer authority over compounding, and it did so by enacting an amended version of Section 503(a) of the Food, Drug, and Cosmetic Act. Congress essentially told the FDA to start enforcing the rules that were already on the books; the DQSA is completely silent on the issue of office use. The FDA, however, immediately indicated it would apply the DQSA in a way that would eliminate office use.

This apparently came as a surprise to some legislators, who wrote a letter to the FDA reiterating that it was Congress’s intent to leave office use up to the states. In a written response, the FDA was resolute in its decision: “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.”

As you might guess, this has caused a tremendous amount of confusion in the medical community and among many state pharmacy boards that have historically allowed office use. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use.

A new amendment from Sen. David Vitter (R-LA)—the Saving Access to Compounded Medications for Special Needs Patients Act—clears up the confusion by amending 503(a) to unambiguously allow office use and preserve the ability of doctors to promptly and effectively treat their patients.

Interstate Commerce and the Memorandum of Understanding

Traditional compounding pharmacies are only allowed to ship 5% of their sales per month out of state, unless they enter into a memorandum of understanding (MOU) with the FDA. The law does not define the limit once a pharmacy has entered into an MOU, but the FDA has created a threshold of 30% in their new rules.

These limits are completely arbitrary and having nothing to do with the safety of consumers. If 30% is safe, why isn’t 10%, or 20%? Is 31% suddenly unsafe for consumers? Is 50%? Additionally, how can a pharmacy be sure that it has not or will not exceed any specific percentage until the end of the month, when it’s too late to do anything about it?

In addition, many states will refuse to sign an MOU with the FDA because by doing so they agree to assume full regulatory responsibility for the pharmacies. In all likelihood, the FDA designed the MOU offer in a way that they knew would be rejected. In our opinion, the objective behind all of this is to shut down compounding simply because it threatens Big Pharma profits, and Big Pharma funds the FDA.

Sen. Vitter’s amendment addresses this issue by stipulating that, if a compounded medication is for an individual patient, there will be no cap on the amount that a pharmacy can ship interstate. It also stipulates that the MOU will not create unfunded regulatory burdens for states, which makes the prospect of entering into an MOU less onerous for states.

The amendment doesn’t fix all the issues that have arisen with new compounding regulations, but it takes a number of strong steps to address some of the worst problems. If passed, this amendment would go a long way in preserving consumer access to important compounded medications.

Action Alert! Write to your senators and urge them to support the Vitter amendment, which would take major steps to preserve consumer access to compounded medications. Please send your message immediately.

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AMA Prepares Gag Order for Medical Dissenters

The American Medical Association’s latest attempt to shore up their medical monopoly could have stiff consequences for practitioners who don’t toe the line. Action Alert!

Angered by what they call “quack MDs,” the AMA recently decided to “actively defend the profession.” In particular, it plans to

create ethical guidelines for physicians in the media, write a report on how doctors may be disciplined for violating medical ethics through their press involvement, and release a public statement denouncing the dissemination of dubious medical information through the radio, TV, newspapers, or websites.

Dr. Mehmet Oz of The Dr. Oz Show was specifically mentioned as being responsible for the type of behavior and “pseudoscience” that the AMA would like to curtail.

One of people who helped craft the AMA resolution to tighten control of doctors in the media is not, in fact, a physician himself, but only a medical student. He told Vox in an interview that “Dr. Oz has something like 4 million viewers [sic]a day. The average physician doesn’t see a million patients in their [sic]lifetime. That’s why organized medicine should be taking action.” In point of fact, Dr. Oz reaches only half that number—but let’s not let a little thing like accuracy stand in the way of an agenda.

Keep in mind that the AMA is not the voice of the medical profession. Its membership has slipped to the point where it represents only 17% of MDs, and many of those are free memberships given to medical students, yet it remains the fifth most powerful special interest on Capitol Hill, spending $19.7 million on lobbying in 2014. This gives it the clout to influence Medicare prices, make recommendations that shape national policy, and raking in about $218.8 million a year from its government-granted CPT medical code monopoly.

Dr. Oz is a high-profile example, but countless integrative doctors in states across the country routinely face harassment and the threat of having their licenses revoked by state medical boards for the most specious reasons—you may recall our past coverage of the Washington state board’s appalling crusade against Dr. Jonathan Wright as only one example among many. But when conventional doctors engage in behavior that is similar to that of integrative physicians—or when conventional docs flout the laws in the most egregious ways—state boards are far more lenient, if any action is taken at all.

The bias, then, is already overwhelmingly against integrative practitioners, and now the AMA is looking to take further steps to silence them. What will happen to doctors who don’t unflinchingly support the CDC vaccine regime, or who inform their patients of any alternative treatment that clashes with conventional orthodoxy? In Europe, it is already illegal for doctors to use the terms “probiotic,” “superfood,” and “antioxidant” when used in relation to commercial food products or supplements—and European doctors who even mention the benefits or health claims of any food, supplement, or non-drug product to patients face jail time. Will we allow free professional speech to be similarly suppressed here? Has the US come to this?

The only way that medical care advances and gradually becomes more scientific is by challenging orthodoxy. Doctors might have killed George Washington by repeatedly bleeding him. The doctor who first told physicians to wash their hands was scorned and harassed. The doctor who first found bacterial involvement in stomach ulcers was vilified until he was eventually exonerated and given prizes. Medical errors, taken as a whole, are today one of the largest single causes of death in the US. How can there be an advances or improvements if critics, researchers, and innovators are all gagged?

At ANH-USA, we believe in a free and open market when it comes to healthcare choices. By doing what it can to gag doctors’ free speech in the media, the AMA is indeed attempting to “defend the profession”—albeit from competition and change, not from those it dismisses as “quacks.”

Action Alert! Write to the American Medical Association and urge them not to go forward with these speech-suppressing ethical guidelines, which will unduly restrict our access to health information. We need to let them know that the American public will not stand for it. Please send your message immediately.

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New Amendment May Help Save Compounded Drugs

Please help us get Sen. David Vitter’s critical amendment passed! Action Alert!

As you know from our continuing coverage, the FDA has been issuing rules to implement the Drug Quality and Security Act (DQSA). This legislation was passed by Congress in 2013 in response to a meningitis outbreak in 2012 involving a single bad actor—a compounding facility in Massachusetts about whom the FDA had received numerous complaints (though the agency took no action other than sending a warning letter to the facility).

Panicked legislators nearly destroyed compounding as an alternative to conventional drugs—something that would eliminate competition for the biggest drug companies, which is why the DQSA seems to have garnered support from Big Pharma allies at the FDA. We were able to amend the law and help save compounding, but some very bad provisions remain. As a result, ANH-USA has been closely monitoring the FDA as it releases drafts of its new rules and guidance documents pertaining to this law.

Compounding, in many cases, is the only way for consumers to access a number of important natural medicines, or to take those medicines in more natural ways. For example, a number of hormones should not be taken orally, but only transdermally. Drug companies and the FDA simply ignore this.

Compounding is important for other reasons as well. In particular, it allows doctors and pharmacists to create medications that are the exact strength, dosage, and ingredient mix best suited to treat an individual patient. Perhaps the medication needs to be gluten free or in lower dosages. We are all different; medicine should never be one-size-fits-all.

We have two main points of contention with the new FDA rules on compounding:

Office Use

“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 the compounded drugs on hand. This enables doctors to provide immediate relief to ailing patients who come into their office, or to have a ready supply for patients whom they have a long history of treating.

For decades, the regulation of “office use” was left up to state pharmacy boards, and most state boards allowed physicians to keep a supply of compounded drugs on hand without prescriptions, recognizing that patients’ well-being depended on it. This changed with the passage of the DQSA.

Congress’s intent was to give the FDA clearer authority over compounding, and it did so by enacting an amended version of Section 503(a) of the Food, Drug, and Cosmetic Act. Congress essentially told the FDA to start enforcing the rules that were already on the books; the DQSA is completely silent on the issue of office use. The FDA, however, immediately indicated it would apply the DQSA in a way that would eliminate office use.

This apparently came as a surprise to some legislators, who wrote a letter to the FDA reiterating that it was Congress’s intent to leave office use up to the states. In a written response, the FDA was resolute in its decision: “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.”

As you might guess, this has caused a tremendous amount of confusion in the medical community and among many state pharmacy boards that have historically allowed office use. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use.

A new amendment from Sen. David Vitter (R-LA)—the Saving Access to Compounded Medications for Special Needs Patients Act—clears up the confusion by amending 503(a) to unambiguously allow office use and preserve the ability of doctors to promptly and effectively treat their patients.

Interstate Commerce and the Memorandum of Understanding

Traditional compounding pharmacies are only allowed to ship 5% of their sales per month out of state, unless they enter into a memorandum of understanding (MOU) with the FDA. The law does not define the limit once a pharmacy has entered into an MOU, but the FDA has created a threshold of 30% in their new rules.

These limits are completely arbitrary and having nothing to do with the safety of consumers. If 30% is safe, why isn’t 10%, or 20%? Is 31% suddenly unsafe for consumers? Is 50%? Additionally, how can a pharmacy be sure that it has not or will not exceed any specific percentage until the end of the month, when it’s too late to do anything about it?

In addition, many states will refuse to sign an MOU with the FDA because by doing so they agree to assume full regulatory responsibility for the pharmacies. In all likelihood, the FDA designed the MOU offer in a way that they knew would be rejected. In our opinion, the objective behind all of this is to shut down compounding simply because it threatens Big Pharma profits, and Big Pharma funds the FDA.

Sen. Vitter’s amendment addresses this issue by stipulating that, if a compounded medication is for an individual patient, there will be no cap on the amount that a pharmacy can ship interstate. It also stipulates that the MOU will not create unfunded regulatory burdens for states, which makes the prospect of entering into an MOU less onerous for states.

The amendment doesn’t fix all the issues that have arisen with new compounding regulations, but it takes a number of strong steps to address some of the worst problems. If passed, this amendment would go a long way in preserving consumer access to important compounded medications.

Action Alert! Write to your senators and urge them to support the Vitter amendment, which would take major steps to preserve consumer access to compounded medications. Please send your message immediately.

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AMA Prepares Gag Order for Medical Dissenters

The American Medical Association’s latest attempt to shore up their medical monopoly could have stiff consequences for practitioners who don’t toe the line. Action Alert!

Angered by what they call “quack MDs,” the AMA recently decided to “actively defend the profession.” In particular, it plans to

create ethical guidelines for physicians in the media, write a report on how doctors may be disciplined for violating medical ethics through their press involvement, and release a public statement denouncing the dissemination of dubious medical information through the radio, TV, newspapers, or websites.

Dr. Mehmet Oz of The Dr. Oz Show was specifically mentioned as being responsible for the type of behavior and “pseudoscience” that the AMA would like to curtail.

One of people who helped craft the AMA resolution to tighten control of doctors in the media is not, in fact, a physician himself, but only a medical student. He told Vox in an interview that “Dr. Oz has something like 4 million viewers [sic]a day. The average physician doesn’t see a million patients in their [sic]lifetime. That’s why organized medicine should be taking action.” In point of fact, Dr. Oz reaches only half that number—but let’s not let a little thing like accuracy stand in the way of an agenda.

Keep in mind that the AMA is not the voice of the medical profession. Its membership has slipped to the point where it represents only 17% of MDs, and many of those are free memberships given to medical students, yet it remains the fifth most powerful special interest on Capitol Hill, spending $19.7 million on lobbying in 2014. This gives it the clout to influence Medicare prices, make recommendations that shape national policy, and raking in about $218.8 million a year from its government-granted CPT medical code monopoly.

Dr. Oz is a high-profile example, but countless integrative doctors in states across the country routinely face harassment and the threat of having their licenses revoked by state medical boards for the most specious reasons—you may recall our past coverage of the Washington state board’s appalling crusade against Dr. Jonathan Wright as only one example among many. But when conventional doctors engage in behavior that is similar to that of integrative physicians—or when conventional docs flout the laws in the most egregious ways—state boards are far more lenient, if any action is taken at all.

The bias, then, is already overwhelmingly against integrative practitioners, and now the AMA is looking to take further steps to silence them. What will happen to doctors who don’t unflinchingly support the CDC vaccine regime, or who inform their patients of any alternative treatment that clashes with conventional orthodoxy? In Europe, it is already illegal for doctors to use the terms “probiotic,” “superfood,” and “antioxidant” when used in relation to commercial food products or supplements—and European doctors who even mention the benefits or health claims of any food, supplement, or non-drug product to patients face jail time. Will we allow free professional speech to be similarly suppressed here? Has the US come to this?

The only way that medical care advances and gradually becomes more scientific is by challenging orthodoxy. Doctors might have killed George Washington by repeatedly bleeding him. The doctor who first told physicians to wash their hands was scorned and harassed. The doctor who first found bacterial involvement in stomach ulcers was vilified until he was eventually exonerated and given prizes. Medical errors, taken as a whole, are today one of the largest single causes of death in the US. How can there be an advances or improvements if critics, researchers, and innovators are all gagged?

At ANH-USA, we believe in a free and open market when it comes to healthcare choices. By doing what it can to gag doctors’ free speech in the media, the AMA is indeed attempting to “defend the profession”—albeit from competition and change, not from those it dismisses as “quacks.”

Action Alert! Write to the American Medical Association and urge them not to go forward with these speech-suppressing ethical guidelines, which will unduly restrict our access to health information. We need to let them know that the American public will not stand for it. Please send your message immediately.

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Action Alert: Help Save Compounding!

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Action Alert: Help Save Compounding!

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Action Alert: AMA Set to Gag Free Speech

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Action Alert: AMA Set to Gag Free Speech

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Yet Another Anti-Supplement Sneak Attack from Blumenthal and Durbin

This time it’s been slipped into a defense bill. Major Action Alert!

We suspected it would only be a matter of time before Sen. Dick Durbin (D-IL) launched his next broadside against supplements. Once again, Durbin and his allies, including Sen. Richard Blumenthal (D-CT), are pouncing on must-pass legislation and attaching last-minute amendments that would threaten Americans’ access to supplements.

The bill this time is the National Defense Authorization Act (NDAA), an appropriations bill to fund the military for FY 2016. The House passed its version of the bill in May. Sen. John McCain (R-AZ) introduced what is called “an amendment in the nature of a substitute” to create a Senate version of the House-passed bill. The Blumenthal/Durbin amendments were introduced on top of the McCain legislation.

Because it is a defense bill, the Blumenthal/Durbin amendments pertain to the supplement use of the US armed forces.

There are three amendments.

The first amendment would require military electronic health records to include data regarding supplement adverse events experienced by servicemen and women. This type of information is already gathered by the FDA, which is much better situated to handle it than the Department of Defense. This additional data collection is redundant and cumbersome. In 2011, Sen. Durbin and Rep. Henry Waxman (D-CA) asked the Government Accounting Office to review supplement adverse event reports (AERs). In 2013 the GAO completed its report—which overwhelmingly demonstrated that supplements are safe! Why in the world is Durbin following the same tactic that embarrassed him so completely two years ago?

According to the resulting GAO report, there were a total of 6,307 AERs reported to the FDA between 2008 and 2011—an average of 1,575 a year. At the time, we pointed out that this was quite a low number, considering the fact that about half of Americans—157 million people—take supplements. This means that one-hundredth of one percent of all supplement users ever experience any problems at all.

If Sens. Waxman and Durbin had cared to search out where the real danger lies for the American consumer, they wouldn’t have had to look very hard. In 2008 alone, there were a whopping 526,527 AERs for FDA-approved drugs, with 275,421 considered serious. Of course, the astonishingly poor safety record of pharmaceutical drugs is irrelevant if you have a vendetta against supplements, as Sen. Durbin and his allies seem to have.

The second amendment would require the Department of Defense to establish minimum requirements for members of the armed forces to report on their supplement use. Service people would be ordered to report what vitamins and supplements they take—which means they could easily be ordered to stop taking them! It is simply Orwellian to have members of the military report on their supplement use. What business is it of the government if a service member is taking vitamin D, or B12? Big Brother shouldn’t be able to reach into your toiletries kit or control what you tell your doctor—even on a military base.

The third and most troubling of the amendments would extend a currently existing policy which regulates certain supplements on military bases to require all supplements that are to be sold to members of the military at exchange stores or commissaries to undergo a third-party review for “recognized public standards of identity, purity, strength, and composition, and adherence to related process standards.” This may sound innocent, but it is anything but.

First, supplements must already, by law, hold to current good manufacturing practices (CGMPs), which require that that they be processed in a consistent manner and meet quality standards. Second, supplement companies will likely be expected to pay huge sums for this review. Only the biggest companies, many of them owned by Big Pharma, will be able to comply. Yet another government-created monopoly will be handed over to big drug companies.

In addition, once this regime is established, it will be only a short step to expand it to all US consumers, not just the military. Then the pharmaceutical industry will have what it really wants: control over the supplement industry. Many supplements will become drugs and soar in price while their availability is restricted. As with any monopoly, quality will also decline, because regulations are never a substitute for real competition involving new and small as well as old and large companies.

Supplements are incredibly safe and already fully regulated by the FDA and FTC. These amendments are misguided attempts to limit access and hamper individual health freedom.

The truth of the matter is that the current regulatory regime governing dietary supplements is working—which is why supplements have such a sterling safety record. In fact, our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.

We’ve come to expect this sort of maneuver from Durbin and company: what can’t be accomplished through more conventional democratic means, they try to accomplish through sneaky, eleventh-hour maneuvering before the public can catch wind of it. This military appropriations bill has nearly 200 amendments attached to it, and not all of them will be discussed by the Senate. With your help, we hope to prevent the Blumenthal/Durbin amendments from ever being considered on the Senate floor. The natural health community has responded vigorously to defeat previous Durbin attacks against supplements: in one instance, our readers sent nearly 90,000 messages in less than twenty-four hours. The time has come again to make our voices heard on Capitol Hill to protect our access to quality dietary supplements!

Major Action Alert! Write or call your senators and urge them to stop the Blumenthal/Durbin amendments, which will take dangerous steps towards limiting consumers’ access to dietary supplements. Please send your message immediately.

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Yet Another Anti-Supplement Sneak Attack from Blumenthal and Durbin

This time it’s been slipped into a defense bill. Major Action Alert!

We suspected it would only be a matter of time before Sen. Dick Durbin (D-IL) launched his next broadside against supplements. Once again, Durbin and his allies, including Sen. Richard Blumenthal (D-CT), are pouncing on must-pass legislation and attaching last-minute amendments that would threaten Americans’ access to supplements.

The bill this time is the National Defense Authorization Act (NDAA), an appropriations bill to fund the military for FY 2016. The House passed its version of the bill in May. Sen. John McCain (R-AZ) introduced what is called “an amendment in the nature of a substitute” to create a Senate version of the House-passed bill. The Blumenthal/Durbin amendments were introduced on top of the McCain legislation.

Because it is a defense bill, the Blumenthal/Durbin amendments pertain to the supplement use of the US armed forces.

There are three amendments.

The first amendment would require military electronic health records to include data regarding supplement adverse events experienced by servicemen and women. This type of information is already gathered by the FDA, which is much better situated to handle it than the Department of Defense. This additional data collection is redundant and cumbersome. In 2011, Sen. Durbin and Rep. Henry Waxman (D-CA) asked the Government Accounting Office to review supplement adverse event reports (AERs). In 2013 the GAO completed its report—which overwhelmingly demonstrated that supplements are safe! Why in the world is Durbin following the same tactic that embarrassed him so completely two years ago?

According to the resulting GAO report, there were a total of 6,307 AERs reported to the FDA between 2008 and 2011—an average of 1,575 a year. At the time, we pointed out that this was quite a low number, considering the fact that about half of Americans—157 million people—take supplements. This means that one-hundredth of one percent of all supplement users ever experience any problems at all.

If Sens. Waxman and Durbin had cared to search out where the real danger lies for the American consumer, they wouldn’t have had to look very hard. In 2008 alone, there were a whopping 526,527 AERs for FDA-approved drugs, with 275,421 considered serious. Of course, the astonishingly poor safety record of pharmaceutical drugs is irrelevant if you have a vendetta against supplements, as Sen. Durbin and his allies seem to have.

The second amendment would require the Department of Defense to establish minimum requirements for members of the armed forces to report on their supplement use. Service people would be ordered to report what vitamins and supplements they take—which means they could easily be ordered to stop taking them! It is simply Orwellian to have members of the military report on their supplement use. What business is it of the government if a service member is taking vitamin D, or B12? Big Brother shouldn’t be able to reach into your toiletries kit or control what you tell your doctor—even on a military base.

The third and most troubling of the amendments would extend a currently existing policy which regulates certain supplements on military bases to require all supplements that are to be sold to members of the military at exchange stores or commissaries to undergo a third-party review for “recognized public standards of identity, purity, strength, and composition, and adherence to related process standards.” This may sound innocent, but it is anything but.

First, supplements must already, by law, hold to current good manufacturing practices (CGMPs), which require that that they be processed in a consistent manner and meet quality standards. Second, supplement companies will likely be expected to pay huge sums for this review. Only the biggest companies, many of them owned by Big Pharma, will be able to comply. Yet another government-created monopoly will be handed over to big drug companies.

In addition, once this regime is established, it will be only a short step to expand it to all US consumers, not just the military. Then the pharmaceutical industry will have what it really wants: control over the supplement industry. Many supplements will become drugs and soar in price while their availability is restricted. As with any monopoly, quality will also decline, because regulations are never a substitute for real competition involving new and small as well as old and large companies.

Supplements are incredibly safe and already fully regulated by the FDA and FTC. These amendments are misguided attempts to limit access and hamper individual health freedom.

The truth of the matter is that the current regulatory regime governing dietary supplements is working—which is why supplements have such a sterling safety record. In fact, our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.

We’ve come to expect this sort of maneuver from Durbin and company: what can’t be accomplished through more conventional democratic means, they try to accomplish through sneaky, eleventh-hour maneuvering before the public can catch wind of it. This military appropriations bill has nearly 200 amendments attached to it, and not all of them will be discussed by the Senate. With your help, we hope to prevent the Blumenthal/Durbin amendments from ever being considered on the Senate floor. The natural health community has responded vigorously to defeat previous Durbin attacks against supplements: in one instance, our readers sent nearly 90,000 messages in less than twenty-four hours. The time has come again to make our voices heard on Capitol Hill to protect our access to quality dietary supplements!

Major Action Alert! Write or call your senators and urge them to stop the Blumenthal/Durbin amendments, which will take dangerous steps towards limiting consumers’ access to dietary supplements. Please send your message immediately.

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