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• There was Sen. Durbin’s dangerous attempt to attach an anti-supplement rider to a spending bill—the infamous Durbin Amendment. His rider would have required, among other provisions, that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. This is a slippery slope to a preapproval process or a ban on high-dose supplements. (You may recall that the IOM suggests 4000 IU of vitamin D as the upper limit for dosage, and says anything greater is dangerous! By contrast, the Vitamin D Council believes 10,000 IU is a safe on a daily basis, with temporarily higher doses to correct imbalances.)  Fortunately, grassroots activists like you sent 100,000 messages in less than twenty-four hours, and the amendment was quickly defeated. We took the opportunity to rebut some of the misinformation Durbin was spreading on the Senate floor.
• Rep. Henry Waxman slipped an anti-supplement provision into the Wall Street reform bill. Because of your messages to Congress, that provision was soundly rejected in an all night reconciliation meeting.
• There were sneak GMO provisions included in the farm bill. The final bill was flawed, but in the end we were able to get rid of three very dangerous provisions.
• The Monsanto Protection Act was attached as a rider to a budget bill in 2013. After it was discovered, Bloomberg, The New York Times, Politico—media of all political persuasions—ran searingly critical articles about the biotech rider despite messages pouring into Congress via our and others’ alerts. The Daily Show mocked Congress, which may have gotten more attention than all the articles. Facebook and Twitter were ablaze with people like you telling their friends and neighbors about the provision, and the outrage was even greater once the legislation was passed. We mounted a campaign to repeal the rider, and thanks to your activism, the controversial provision was removed from the next funding bill that was signed into law.

Please keep a watchful eye on your email inbox for the next few days. If we spot any riders, we will send out an emergency Action Alert and ask you to contact your legislators immediately.

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Capitol Hill’s most powerful special interests resorted again to underhanded tactics.

• The King Amendment. Perhaps the most crucial concession won was the removal of the unconstitutional King Amendment (a.k.a. the Interstate Commerce Amendment), which violated states rights and could have unraveled hard-won GMO labeling and animal rights laws. You called and wrote and harangued until that provision was dropped. Well done!
• More FDA Oversight. The final bill includes Section 11321, which will force the agency at least to study how new Food Safety Modernization Act rules could hurt small farms. This amendment helps shield family farmers from FDA overreach and could help protect consumer choice, as it’s less likely that farmers will be forced to either shut down or raise prices to implement expensive FDA regulations.
• No Shield for Big Ag. The final Farm Bill does not contain Section 1613, which would have prevented any government agency from disclosing any “information provided by a producer or owner of agricultural land concerning the agricultural operation.” Essentially, this would have outlawed the reporting of Big Farma’s most dangerous “oopsies,” including GMO crop contamination, antibiotic abuse, and livestock disease outbreaks.

The Farm Bill is just a taste of the legislative battles we’ll face in 2014. Stay tuned as we tackle this year’s toughest challenges, including the IRS attack on free speech, Senator Durbin’s Anti-Supplement Zombie Bill (it just won’t die!), and the next draft of the NDI guidance. The fight has just begun!

The post The Farm Bill: Three Big Wins, but One Dangerous Fluoride Amendment first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Whew! We won’t soon forget the all-night conference committee meeting in which Waxman tried to slip in an anti-supplement amendment written so that even a lawyer could not understand it.

• Food Safety Enhancement Act of 2009: Defeated! FSEA, also known as the Waxman-Dingell bill, would have given FDA unprecedented power over supplement producers and small farmers, even allowing ten-year prison terms for minor administrative violations! But calls and messages to Congress ensured this bill never made it out of the Senate.
• Anti-Supplement Amendment to the Wall Street Reform Act: Rejected! In 2010, Congressman Waxman introduced an amendment that would have awarded the Federal Trade Commission the power to essentially disregard DSHEA—the main legislation protecting consumer access to supplements. The provision’s language was virtually indecipherable to any but a trained legislative expert, and was buried in a completely unrelated bill. This amendment could have easily passed unnoticed— but it was discovered in time and congressional conferees were flooded with messages.
• GAO Fear-Mongering on Supplement AERs: Flopped! In the wake of several failed anti-supplement bills, Congressman Waxman allied himself—as you might expect—with anti-supplement Senator Dick Durbin to try a new tactic: they asked the Government Accountability Office (GAO) to review adverse event reports (AERs) for dietary supplements. The goal was to prove how “dangerous” dietary supplements were…and instead overwhelmingly demonstrated their safety.
• Desire to Amend DSHEA: Thwarted! Since DSHEA passed in 1994, Rep. Waxman has been eager to repeal it. Thanks to natural health activists, as well as our staunch Congressional allies, Rep. Waxman’s wish never came true.

As you might have guessed from all this, Rep. Waxman’s top supporters were from conventional medicine. This is clearly reflected in his fundraising: in 2012 alone, his reelection fund and PAC received $187,000 from health professionals, $89,250 from hospitals, and $64,000 from pharmaceutical and “health product” companies.

Although Waxman was doggedly anti-supplement, there were brief moments when we were on the same side. For example, in 2009, he called out the FDA for granting special favors to chemical makers, and demanded the FDA reassess the safety of BPA. He also reportedly supported removing Section 1613 from the current Farm Bill, which would have essentially covered up Big Farma’s agricultural, ecological, and animal rights disasters.

As Rep. Waxman himself famously said, nothing is ever “settled for good” in Washington. ANH-USA will keep an eye out for Capitol Hill’s next Waxman. There will always be people who for whatever reason are trying to use government to create health product monopolies and force us all into a one-size-fits-all style of medicine. But no one, we hope, will ever be so skilled at sneaky legislative maneuvers.

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• The new bill contains sections that would ban doctors from prescribing compounded nutrients delivered intravenously unless they are on a pre-approved list, have a USP monograph, or are components of FDA-approved drugs. Imagine: your doctor cannot give you an IV containing natural vitamins and minerals unless these ingredients happen to be in some FDA approved drug! Moreover, such IVs are some of the best tools that integrative doctors have.
• The language about needing to have a USP monograph or being components of FDA-approved drugs came from an old section of the Food, Drug, and Cosmetics Act that had been deemed invalid by federal courts, so in 47 states, physicians have recently had the freedom to prescribe and dispense compounded nutrients of their choice by IV. If the new bill passes, this will become illegal in all 50 states, at least until another legal challenge can be mounted.
• The bill makes the falsification of a compounded prescription a federal criminal act. The trouble with this is that states are supposed to have jurisdiction over the practice of medicine. This will take the federal government even further into the doctor’s office.
• Also in this new bill, compounded “copies” of FDA-approved and marketed drugs would still be considered illegal. This would enable drug companies to raise prices on some drugs to astronomical levels.

As the Senate prepares to pass this, these very bad provisions notwithstanding, we should remember that we were successful in changing many troubling elements of the original Senate bill. For example:

• The previous version of the bill would have allowed the FDA to identify bulk ingredients not “suitable for compounding” based on “public health concerns” even if they have a USP monograph. We managed to strike the language that a USP monograph would not provide protection. Since important ingredients like estriol have a USP monograph, this change will ensure that estriol is protected from the FDA and remains available for the millions of women who rely on it! This was a major victory.
• We ensured that compounders could make non-standardized dosages of drugs so you can have the right dosages instead of cutting pills in half.
• The new version of the bill maintains the standard we inserted (from current law) for “difficult to compound.” Previously the bill had no standard, giving the FDA too much flexibility to ban whatever they wanted. It also doesn’t include time-released medications among those supposedly “difficult to compound” and therefore banned.
• The provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard was removed. This was a backdoor approach to banning compounded medicines, because everyone knows that no one could afford to pay for those trials of non-patentable drugs, and RCTs in any case are inappropriate for individualized medicine.
• We were also able to remove the requirement from the previous version of the Senate bill that doctors must substantiate the need for a compounded prescription.
• And the bill no longer sets up the impossible to measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales or require physician reporting within a few days.

We will develop a strategy for how to deal with the remaining problems in the bill if the Senate passes it as expected. As noted above, this will probably involve challenging some of it in court.
URGENT Action Alert! (1) Please send your senators another Action Alert email, and ask them to amend the Senate compounding bill immediately. Then (2) PHONE your senators on the off chance that someone is still there—use our Action Alert for your talking points. Most senatorial staffers are out since the government has shut down, so when you phone, if you don’t speak to someone in the senator’s office, call back again when the government opens back up. We cannot stress how urgent this is—please take action TODAY!

The post No Time to Lose on the Senate Compounding Bill! first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Nutritional deficiencies such as iodine, iron, selenium, zinc, vitamin A, riboflavin, pyridoxine, and B12, along with the use of certain medications including beta-blockers, birth control pills, estrogen, iodinated contrast agents, lithium, phenytoin, and theophylline, can inhibit the conversion of T4 into T3. Other factors that can cause this inhibition include aging, alcohol, alpha-lipoic acid, diabetes, fluoride, lead, mercury, pesticides, radiation, stress, and surgery.

Another problem is that too much T4 can convert to something called “reverse T3,” which has only 1% of the effect of T3, but also binds to the T3 receptor, thus blocking T3 from doing its job:

Factors that may lead to a preferential conversion to reverse T3 include high cortisol, glucocorticoids, stress, excess estrogen, and nutritional deficiencies such as selenium, iodine, zinc, and iron.

All of these factors are common. Some—such as aging, stress, fluoride, and pesticides—are so ubiquitous that it is easy to imagine that a large percentage of thyroid patients are inadequately converting T4 to T3, and thus need a thyroid preparation that contains some T3. There is also the possibility that T1 and T2 are performing functions in the body that we are not yet aware of, and that they need to be supplemented along with T3 and T4 (as they are with DTE).
The basic screening test for hypothyroidism is the TSH test, which is short for thyroid-stimulating hormone. TSH is secreted by the pituitary gland when it senses that thyroid levels in the blood have dropped too low, so low levels of TSH generally mean that there is plenty of thyroid hormone in circulation. But for a variety of reasons, the pituitary can sometimes fail to produce enough TSH (even though thyroid levels are low), in which case a low TSH level would give the false impression of having plenty of thyroid. And even under optimal circumstances, TSH levels can fluctuate.
In 2002, the American Association of Clinical Endocrinologists (AACE), recognizing that many patients are misdiagnosed, lowered the upper end of acceptable TSH levels from 5.0 to 3.0, doubling the number of people needing treatment for hypothyroidism. Under the old guidelines, these people had been considered totally normal, and many had been denied treatment despite predisposing family histories and symptoms such as weight gain, depression, fatigue, hair loss, constipation and high cholesterol, all of which can be caused by low thyroid.
Is it any wonder that best-selling thyroid author Mary Shomon’s motto is, “We’re patients, not lab values”?
Speaking of the acceptable TSH ranges, Shomon notes:

This narrow-minded means of diagnosis has been the “standard of care” for conventional doctors and endocrinologists for decades, based on a near-slavish reliance on the TSH test—often to the exclusion of clinical evidence, symptoms and medical observation.

On About.com, Shomon has questionnaires to assess the risk of both hypothyroidism (too little) and hyperthyroidism (too much).
Another approach followed by some integrative doctors is to use an underarm temperature test, which may be more reliable than the TSH test. One simply measures underarm temperature before getting out of bed. A temperature below 97.4 for several days running generally indicates a problem.
In 2009, thyroid patients on DTE were thrown a loop when the two major makers of DTE—Armour and Nature-throid—both experienced mysterious shortages and could not meet demand at the same moment. Many patients spent hours on the phone, calling pharmacy after pharmacy to find a source of DTE. Fortunately, compounding pharmacies were able to fill in, as they can make DTE in any dose, using the same raw materials as Armour and Nature-throid (although at a higher price).
We’ve been telling you over the past few months (here and here) about a bill moving through Congress to outlaw certain compounded medications. This bill is a blatant move by pharmaceutical companies to eliminate the competition from compounding pharmacies and force people to buy the mass-marketed version of the drugs. That would mean that in the event of future shortages of DTE, people might be forced to switch to the T4-only preparations that leave so many patients with unresolved symptoms.
If you haven’t sent an Action Alert yet on the compounding bill, it’s not too late. We’re asking the Senate to vote No on S.959, to ensure that we don’t lose access to the important therapies supplied by compounding pharmacies. Please take action today!

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• Bulk ingredients. The bill would allow FDA to identify bulk ingredients not suitable for compounding based on “public health concerns,” which is an impossibly vague standard. FDA has attempted to ban bioidentical estriol because of such “health concerns” even though it has a USP monograph!
• “Copies of drugs.” Compounded versions of FDA-approved drugs may be banned as “copies” of the drugs depending on how strictly that term is interpreted. This could eliminate access to the much less expensive 17P in favor of the FDA-approved Makena drug. Remember that pharmaceutical companies view compounding pharmacies as a threat to their market share. On the upside, the new version of the bill says that if the FDA-approved drug is in short supply, a pharmacy can compound the drug—it only needs to provide one notice per year. Of course, “short supply” has to be defined by the FDA.
• “Difficult to compound.” The bill allows the FDA to disallow entire categories of drugs that are supposedly “difficult to compound,” and specifically names “complex dosage forms” as an example. This targets products such as extended-release products and transdermal patches (for example, many consumers rely on time-release thyroid medication, which is not available in standard drug form).

Some small victories, however: in the previous version of the bill, there was no clear definition of what “difficult to compound” really meant. We had requested that bill include language that exists in current law, and at least use a standard based on safety or effectiveness. In the new version of the bill, compounding must be “reasonably likely to lead to an adverse effect on the safety or effectiveness of that drug or category of drugs, taking into account the risks and benefits to patients.” We also got them to remove the provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard, as well as the requirement that doctors must substantiate the need for a compounded prescription.
What this means is that your messages are working! Your legislators really do listen to you.
There is conflicting information on when the bill will come up for a vote. Last week our sources indicated it wouldn’t come up until after the August recess. Yesterday, however, we heard that it might come up for a vote as early as tomorrow. The bill’s Senate supporters are pushing hard for a floor vote before the August recess, whereas Sen. Coburn said that more time was needed to review the new language and have industry weigh in.
No time to lose, then! If this comes up for a vote this week, the Senate needs to hear from you TODAY! Your message is simple: ask your senators to oppose S.959.

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Contact:
Gretchen DuBeau
202.290.9178
gretchen@anh-usa.org

Drug Companies Attempt to Use Legislation
to Remove Compounded Medications from the Market

A controversial bill concerning compounded drugs is little more than a smokescreen for a power grab by the pharmaceutical industry

July 10, 2013 — The Alliance for Natural Health USA (ANH-USA) announced today that major pharmaceutical companies—under the guise of the Working Group on Pharmaceutical Safety—are pushing for the passage of S.959, the Senate compounding pharmacy bill, to weaken perceived competition by compounding pharmacies. The Working Group is composed of former FDA officials, powerful politicians-turned–industry advocates, and an influential lobbyist married to a key Senate staffer.

“The legislation is presented as a response to last year’s problems at the New England Compounding Center, where poor quality controls led to several batches of steroid injections becoming tainted with a fungus,” said Gretchen DuBeau, ANH-USA’s executive and legal director. “This was an outbreak that US Food and Drug Administration Commissioner Margaret Hamburg conceded last month was due to FDA inaction, despite the many complaints they had received about the facility. Unfortunately, this bill does little to actually increase the safety of compounded medicines or improve facility inspections, and rather makes it easier for FDA to ban many compounded drugs altogether.”

In particular, the bill allows the FDA to disallow entire categories of compounding drugs in so-called “complex dosage forms,” such as extended release products or transdermal patches. “Millions of women and men depend on compounded time-release thyroid medications in both the complete and active forms, neither of which is available in standard drug form,” DuBeau continued.

In addition, compounded estriol, which is biologically identical to the hormone produced by women’s bodies, is used by millions of women for hormone replacement therapy. “Estriol became popular in the first place because the standard drug used for the same purpose was proven to be dangerous, a risk for both heart disease and cancer,” DuBeau explained. “Now the pharmaceutical industry is trying to hijack this bill to outlaw compounded estriol and thyroid. Their goal is to replace these compounded medications with standard drugs and recapture their lost share of this massive market.”

In a remarkably candid interview with Bloomberg, the CEO of TherapeuticsMD, a key player in the Working Group on Pharmaceutical Safety, recognized the superior safety of bioidentical hormones. DuBeau stated, “This is important because FDA’s main argument against estriol has been that it is by definition unsafe because it has not won FDA approval. This CEO openly admits that his company sees these hormones as a $10 to $12 billion market that they want to control by offering them as FDA-approved drugs.”

Even more telling, ANH-USA has obtained a document in which TherapeuticsMD, pitching itself to potential investors, describes the safety and efficacy of bioidentical hormones. They also give their investors statistics on the bioidentical HRT market, reveal that well over three-quarters of the market is currently held by compounding pharmacies, and state that this is the market they are pursuing.

“The Working Group on Pharmaceutical Safety and their clients have a direct financial interest in language that would allow the FDA to shut down vital compounded medications—and thus a vested interest in passing S.959. Certain drug companies want to take advantage of what is supposed to be regulation of the compounding industry by replacing compounded products with their own,” DuBeau concluded. “Will Congress please take note and amend this legislation before it is too late?”

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About the Alliance for Natural Health USA (ANH-USA)
www.anh-usa.org
The Alliance for Natural Health USA is part of an international organization dedicated to promoting natural, sustainable healthcare through good science and good law. We protect the right of natural health practitioners to practice and the right of consumers to choose the healthcare options and treatment modalities they prefer, including complementary and alternative medicine. As a membership-based organization, we unite consumers, practitioners, and industry to speak with a common voice and have worked since 1992 to shift the medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an “integrative” approach incorporating food, dietary supplements, and lifestyle changes.

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