Government Vaccine Committee Considers How to Build Vaccine Confidence

…but verifying or improving the safety of vaccines is not on the list. Action Alert! You may remember our article on the National Vaccine Advisory Committee’s (NVAC) plan to increase adult immunizations, which could eventually lead to adult mandates. Now, NVAC’s Vaccine Confidence Working Group has released a draft report that considers “how confidence in vaccines impacts the optimal use of recommended childhood vaccines in the United States.” It is clear from the first lines of the draft report that, from the perspective of the Working Group and NVAC, parents who disagree with the government’s recommended vaccination schedule need to be steamrolled, not reassured. The very existence of such parents amazes the authors. The draft report states, “[There are] parents whose reluctance, hesitation, concerns, or lack of confidence has caused them to question or forego recommended vaccines.” Imagine! The report goes on to say that the ultimate goal is to “achieve acceptance of all Advisory Group on Immunization Practices (AGIP) recommended vaccinations by parents and healthcare providers.” This recommended schedule is more or less the same as the CDC’s, which include about nineteen injections in the first six months of life. This is a crucial point. While one could read this report and naively think that there is a good faith attempt on the part of government health officials to answer real questions about vaccine safety, the real intent seems to be to find the most effective propaganda techniques to convince everyone of the virtues of the CDC’s vaccine schedule without any review or modification whatsoever. A number of the recommendations made by the Working Group to achieve these ends are particularly troubling. One such proposal is to ramp up already existing pay-for-performance initiatives, which are financial incentives or mandates for physicians to achieve both “an immunizing standard within a practice” as well as “continued improvement in immunization coverage rates within a provider’s practice.” This recommendation would also provide billing codes for vaccine counseling, so doctors can “gauge how they are performing when taking time to explain the risks and benefits of vaccination to parents or patients.” In fact, docs can just check a box and they will receive even more money from insurance companies, just for trying to convince parents to vaccinate their kids. In other words, doctors get more money if they hit a certain vaccination standard, with a bonus for counseling their patients to vaccinate, or they get paid nothing if they fail to hit the required number of vaccinations. They have a double incentive to urge vaccination, which is actually a disincentive for physicians to provide balanced information. The fact that this sets up a glaring conflict of interest is surely blindingly clear to the health officials responsible for this report. These incentives or mandates would never be disclosed to the patient. It will all be done in secret. The Working Group also recommends that states “strengthen” their policies regarding personal belief and religious exemptions to vaccination, thus ensuring that exemptions “are only available after appropriate parent education and acknowledgement of the associated risks of not vaccinating, to their child and community.” Among the more telling recommendations made by the Working Group to achieve full confidence in vaccinations is the following: NVAC recommends [that] healthcare providers, immunization programs, and those involved in promoting recommended vaccinations actively reinforce that vaccination according to the ACIP recommended schedule is the social norm and not the exception. Misperceptions that vaccination in line with the ACIP recommended schedule is not the norm should be appropriately addressed [emphasis added]. In other words, why use rational discussion to address a parent’s concerns when shaming and school-yard-style peer pressure will do? Will this lead to putting parents in jail, as Maryland did briefly? There’s a certain logic to the strategy of callously dismissing reasonable concerns about vaccine safety and labeling parents concerned about their children as irrational, uneducated “nuts”: when you marginalize the opposition, nothing need be done to improve vaccine safety—a topic that very few people in government and the scientific community (and none in the vaccine industry) seem to be concerned about. Action Alert! Submit your comment to NVAC and tell them that they need to listen to parents and be willing to make changes in vaccine ingredients and schedule. Informed consent is the basis for a sensible policy on vaccination—not bullying and public humiliation. Please send your message immediately.

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One-Third of Seniors with Dementia Are Being Given Antipsychotics

—even though such toxic drugs are not approved to treat dementia! A report from the Government Accountability Office (GAO) found that nearly one-third of older adults with dementia who spent more than 100 days in a nursing home were given antipsychotics through Medicare’s prescription drug program in 2012. We previously reported that a similar situation exists with brain-damaged veterans—and even with infants and young children, especially those treated through Medicaid. They are all given these very toxic and inappropriate medications. Why is this happening? Are Big Pharma profits more important than the health of our most vulnerable populations—seniors and young people? A bipartisan pair of senators are now calling for the Department of Health and Human Services (HHS) to investigate the potential misuse and overuse of these drugs. According to the letter from Sens. Tom Carper (D-DE) and Susan Collins (R-ME), nearly 30% of seniors in nursing homes and nearly 14% living outside of nursing home care are being given antipsychotics to treat the behavioral symptoms of dementia—despite “specific warnings that they not be given to patients with dementia due to an increased risk of falls or death”! The FDA has never approved such drugs to be used for behavioral problems from dementia, nor for use in especially vulnerable populations such as children, seniors, or brain-damaged patients. So where is the FDA here? By law, no drug can make a claim to treat disease without FDA approval for each treatment use. If you want to use a drug approved to treat heart disease on patients with diabetes, you have to seek the FDA’s approval of the drug specifically for diabetes—and pay another billion dollars for the clinical trials and drug approval process. Antipsychotic drugs have a long list of serious side effects, including hypotension, movement disorders, and metabolic syndrome issues. Aside from the appalling abuse and maltreatment represented by prescribing the off-label use of antipsychotic drugs to young children and now seniors, the sheer cost to the American taxpayer is staggering, according to the senators’ letter: to treat seniors with dementia with antipsychotics cost Medicare $363 million in 2012. Between 1999 and 2008, Medicaid more than doubled the amount it spent on antipsychotics—more than any other class of drugs. This is great news for the pharmaceutical companies manufacturing these drugs, but less exciting for the seniors and children to whom they are administered. Along with calls to reduce the use of antipsychotics by 30% by 2016, the letter also calls for alternative treatments. We’ve reported before that there has been strong evidence to show that coconut oil can prevent, and even reverse, Alzheimer’s disease and dementia. Fish oil has also been found to reduce the inflammation associated with dementia, with one study finding that the risk of all forms of dementia could be reduced by almost half with fish oil. Encouraging work has shown that B vitamins could reduce the rate of brain atrophy in patient with mild cognitive impairment—50% of which go on to develop Alzheimer’s. HBOT (hyperbaric oxygen therapy) is one of the best treatments for brain damage. Most hospitals have the HBOT tanks. But because they are not FDA-approved for this use, they sit empty most of the time. HHS should promote these alternative, natural, and safer approaches to treating these diseases. But it won’t, because in our opinion it is a prime example of a government agency captured by special interests—one no longer principally concerned with working for the welfare of the public.

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FDA Doubles Down on Censoring Food Labels

As usual, it gets the science wrong, and we think we detect a hidden, commercial motive as well. Action Alert! The FDA recently sent a warning letter to KIND, the company known for making several varieties of fruit-and-nut bars. The letter contends that four of KIND’s products bear the claim on their labels that they are “healthy and tasty, convenient and wholesome” without meeting the federal definition of “healthy.” As part of this definition, a food cannot exceed one gram of saturated fat per “reference amount customarily consumed”—basically, one gram of saturated fat per serving. According to KIND’s website, the four bars mentioned by the FDA contain anywhere between one and five grams of saturated fat. Even if saturated fat were actually bad for your heart, which scientists have now refuted, this wouldn’t exactly be an artery-clogging amount. Other absurdities abound. The FDA’s letter was also thorny about KIND’s use of the words “plus,” “antioxidant-rich,” and “good source of fiber” on their labels. But let’s focus on saturated fat for the present. As we’ve said, the idea that we should avoid fat is just a myth with no current scientific support. There is a great deal of evidence now suggesting that saturated fat—in particular, saturated fat from the right sources—is not the main culprit in heart disease or obesity, misinformation from the American Heart Association notwithstanding! In fact, saturated fat from foods like butter from grass-fed cows, avocados, coconut oil, and eggs has numerous health benefits. The real source of obesity and related ills such as diabetes and heart disease is sugar, and the starchy foods that break down into sugars in the body, plus of course a lack of exercise. We’ve covered the negative health effects of different types of sugar and sweeteners elsewhere. Dr. Joseph Mercola has also been a staunch critic of sweet drinks—whether sweetened by sugar, high-fructose corn syrup, or artificial sweeteners—because of the link to obesity and other diseases. The sweetener used in KIND’s bars is usually honey. We don’t eat much of it ourselves, because it is a form of sugar, but it is at least a more natural form, assuming the honey in question is raw and organic. And, from what we can tell, most of the saturated fat in the bars comes from nuts like almonds, cashews, and peanuts. Basically, apart from the sugar content, the bars seem mostly healthy! The main takeaway is that the FDA is using pathetically outdated science in its action against KIND and its overall determination of what is “healthy”—not unlike the Dietary Guidelines Advisory Committee’s recommendations about reducing red meat in our diet, which totally ignored the vast nutritional differences between grain-fed, hormone- and antibiotic-infused beef and grass-fed organic beef. Unfortunately, we don’t think this is just a case of the FDA simply being woefully ignorant of the latest science. There may be another, perhaps even more insidious, game being played. If the FDA is going to start hitting companies for inappropriately claiming their products are “healthy” on the labels, this could be just the opening salvo in a renewed attack on food and supplement producers claiming any health benefits from their products, no matter how much supporting science there is. Bear with us for a moment as we sort through some FDA law:

• At present, the law does not allow the seller of a food or supplement to say that the product will help prevent or treat a health condition or disease. Only a drug company selling an FDA-approved drug may make such a claim.
• Any violation of this rule can result in massive fines and a long jail sentence. For example, the producer of a vitamin D supplement cannot legally cite the science showing that vitamin D prevents and treats the flu. Influenza is a disease, so this is forbidden, no matter what the science says.
• The supplement producer can, however, make a legal structure/function claim—for example, by saying that vitamin D “supports immune system function.”
• Alternatively, the vitamin D producer might ask the FDA for permission to make a qualified health claim, saying that vitamin D may prevent or treat the flu (note the qualifying term “may”). But the FDA never agrees to allow this unless the agency is dragged into court at vast expense. An FDA employee once told a lawyer involved in this kind of litigation that he would have to keep suing and suing, because the agency had unlimited legal funds and he didn’t.

As we’ve seen before, this wouldn’t be the first time the FDA has tried to attack structure/function claims or qualified health claims. The agency has been trying for years to lump food, supplements, and drugs all into one category, to be subjected to the same regulations. The problem, of course, is what we call the “Catch-22” of drug economics: it costs billions of dollars to go through the FDA’s drug approval process, which is an entirely prohibitive cost to natural supplement and food companies because they cannot patent protect their products, whereas Big Pharma companies are able to patent their new-to-nature molecules—and charge exorbitant sums to consumers. FDA success in this regard would be a great boon for the pharmaceutical industry, because competition would be eliminated. This, in turn, is good for the FDA, because Big Pharma pays the agency’s bills, in addition to offering lucrative employment for those who leave government. For consumers who want information so they can make informed choices about food, however, it would be a devastating loss. Consumers are already willfully kept in the dark about the value of nutritional superfoods such as walnuts and cherries. If there were no structure/function claims, the supplement industry would be crippled. Action Alert! Write to the FDA and tell them to stop censoring truthful scientific information on food labels, and especially stop the kind of censorship based on junk science. Please send your message immediately.

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Why Does ConsumerLab.com Refuse to Answer Our Questions?

We asked them about their dubious business practices, but we have received nothing but stony silence in return. Help us learn what they are hiding—Action Alert! Over the last few years, we’ve raised questions about the business practices of ConsumerLab.com, an organization that purports to help consumers identify the highest quality dietary supplements. As we’ve reported before, our sources tell us that ConsumerLab.com (CL) approaches dietary supplement makers and asks them to enroll in its “voluntary” testing program—for a fee. CL doesn’t publicly disclose its fee schedule, but we were told that one company was charged over $4,000 to test a single product. We also understand that companies that pay the fee are guaranteed that if one of their products passes the testing under their Voluntary Certification Program, it gets listed on the site and may carry the CL Seal of Approval—and if it fails the testing, the product will not be identified publicly because the results are “proprietary to the manufacturer”! Companies that do not agree to pay for the voluntary certification program risk having their products tested anyway through the firm’s “product review program.” If they fail the test, those failures will be publicized on CL’s website and 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.” Unfortunately, our efforts to verify all the facts and get an explanation have not been answered. We sent the following letter to CL a year ago, asking them to address some of these issues:

We represent Alliance for Natural Health USA (“ANH-USA”), which questions, inter alia, the validity of using the amount of time it takes for a product to disintegrate in water as ameasure of quality when the stomach does not use water to digest products. ANH-USA is concerned that CL employs questionable methods to evaluate products andis acting out of financial self-interest while proclaiming that its “mission is to help consumer and health professionals identify high quality products” [emphasis in original]. A responsible public interest organization dedicated to ensuring quality in the market should have no problem accounting for its methods. On behalf of ANH-USA, we therefore pose the following questions to you: 1. 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? 2. 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”? 3. How does withholding information from the public about failing products “help consumers and professionals identify high quality products”? 4. What selection criteria do you employ to choose a product for a Product Review? Please also explain in detail how you use survey results to select products. If some products are chosen at random, please explain the randomization process. 5. Prior to finalizing the list of products that you will test under a Product Review, do you notify companies that their products are under consideration for inclusion, and, if so, do you provide them an opportunity to have their products tested through CL’s Quality Certification Program instead? 6. How does the price for product testing through CL’s Quality Certification Program compare to the price of product testing through a third-party laboratory that does not release Product Reviews to paying members? Is it higher? 7. On CL’s website, www.consumerlab.com, you acknowledge that “[t]he FDA’s Good Manufacturing Practices (‘GMPs’) for dietary supplements allow each manufacturer to determine the quality standards and analytical methods it uses to evaluate the quality of its products.” Nevertheless, you claim that even if a product complies with GMPs, it can still be of low quality. For example, you state that “[s]ome choose to use less specific standards and/or lenient test methods that can make a low quality product appear to be high quality.” You further claim that your standards are better, stating: “We adopt the most meaningful and strict standards based on the latest international research and recommendations.” What evidence can you provide to demonstrate that your quality criteria/standards and tests are generally accepted in the scientific community as sufficient to determine definitively a product’s quality? Further, what evidence can you provide that your tests are appropriate for each product that you evaluate, and how do you, or the laboratories that you use, account for confounding factors, if at all, such as ingredients that either mask or magnify test results? 8. Which laboratories do you use to test products and what evidence do you possess that their testing methods and results are competent, reliable, and reproducible? We look forward to receiving your prompt response within 30 days after the date of this letter. ANH-USA intends to publish a copy of this letter within the next several months along with any response you send.

ConsumerLab has yet to respond to these concerns. Action Alert! Write to your state’s attorney general and the Federal Trade Commission (FTC) and ask them to investigate the business practices of ConsumerLab.com. Please send your message immediately!

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NY Attorney General—and Now Thirteen Other AGs—Take Their Assault on Supplements to Congress

They seem determined to treat supplements like drugs. Problem is, no one will pay billions for FDA approval, and most of your supplements will disappear from the shelves. Major Action Alert! New York Attorney General Eric Schneiderman has again upped the ante in his assault on the supplement industry. We recently reported how Schneiderman used a poorly designed—and now completely discredited—test to challenge some herbal supplements. But egg on his face hasn’t slowed him down. Late last week, he sent a letter co-signed by thirteen other AGs asking Congress to “launch a comprehensive congressional inquiry in the herbal supplement industry” because “a current state investigation has raised serious concerns about the marketing and safety of the herbal supplements regularly consumed by millions of Americans.” As we and others have shown, the only concerns the investigation actually raised were about the scientific incompetence of the New York AG’s office. Even a recent compromise with GNC, one of the companies Mr. Schneiderman investigated, which agreed to voluntarily begin using DNA barcoding on its products, was apparently not enough to slow down the crusading AG. The letter calls for certain congressional subcommittees, in conjunction with the FDA, to conduct an investigation that would consider tightening supplement regulations, including new rules regarding ingredients, labeling guidelines, and manufacturing practices—all supposedly to enhance quality assurance, in an industry that already has an exemplary track record for quality—and ramping up existing controls, supposedly to ensure the safety and effectiveness of finished products sold by retailers. In itself this does not sound objectionable. But keep in mind that virtually all of what they’re asking for is already covered by existing federal regulations. Supplements are a highly regulated industry. The only remaining regulation they could possibly have in mind is to subject supplements to the multi-billion-dollar FDA drug safety and efficacy approval process. The NY AG knows full well that no one will ever pay for that since supplements, being natural, cannot generally be patented. Let’s not forget the following:

• Current good manufacturing practices (cGMPs) for supplements could not be more stringent. Laws to guarantee safe products are already on the books, and it is up to the FDA to enforce those laws. FDA memos, retrieved through Freedom of Information Act requests, show that the agency has, at least in the past, deliberately refused to enforce laws in the hope that something would occur which was so bad that current supplement law would be abandoned in favor of a drug-type regulation scheme. If once in a great while some bad actors fail to meet current high standards, and the FDA fails to hold them accountable, this should not reflect on the entire industry. The FDA already has the power it needs, so passing more regulations would simply be redundant.


• The testing regimens which the supplement industry are held to under cGMPs are one reason that supplements have such a proven track record of safety—more so than food, not to mention FDA-approved pharmaceuticals. One report from the Government Accountability Office found that there were an average of 1,575 adverse event reports (AERs) related to supplements per year between 2008 and 2011. When you factor in that about half of Americans (157 million people) take supplements every day, this means that only one-hundredth of one percent of all supplement users ever experience any problems at all. It is also worth noting that AERs are not concrete evidence of supplements being a factor in an adverse event, but simply a possible correlation. By contrast, in 2008, there were was 526,527 AERs from pharmaceuticals—488 times more than the number of supplement AERs. Our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.


• Because cGMPs already cover the lion’s share of what the AG’s letter is asking for, what Mr. Schneiderman and the other AGs really seem to be after—as evidenced by their use of specific language like “safety and efficacy”—is a regulatory regime that would subject supplements to the same pre-approval process that pharmaceutical drugs must go through. An economic analysis ANH-USA conducted in response to a less-stringent regulatory proposal than the one Mr. Schneiderman seems to be asking for found that between 22,240 and 41,700 dietary supplements would disappear from the market as a result. This hurts consumers far more than it helps them.

Given these considerations, one wonders what is motivating Mr. Schneiderman and his coalition of AGs in the first place. Is he trying to curry favor with the drug industry, in the hope that this will help him finance future campaigns—for governor, perhaps? There will be a huge political upside for him if Congress decides to act. It will create a media frenzy, with the NY AG’s name headlining all the stories, without his having to make a viable case for his position—something he has so far been unable or unwilling to do—or explain how any of this benefits New York’s taxpayers. The possibility exists, of course, that he is simply misinformed. This is disturbing, since his initial tests have been completely invalidated. With no safety violation and no evidence of fraud, the NY AG’s office might have withdrawn its case and issued a mea culpa. If the entire process was predicated on faulty data, which appears to be the case, the AG needs to explain how his office could have acted so rashly and with such gross incompetence. Instead—and without a scintilla of scientific evidence or a single public health violation—he has redoubled his attack. One thing is certain: consumers must speak out in a clear voice to tell congressional leaders not to cave in to these specious demands and to preserve consumer access to important dietary supplements. Action Alert! Send a message to the senators who received this letter and urge them to protect our access to quality supplements! Please send your message immediately!

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FDA May Be Preparing Attack on Homeopathy

The time to stop this is now, before it gains momentum! Action Alert! The FDA is holding a public hearing later this month to evaluate its enforcement policies for homeopathic drug products. It says the agency is seeking input on whether and how to adjust the policy to adjust for changes that may have occurred over the past twenty-five years. Why is the FDA doing this? First, a little background: in 1938, in early FDA formation legislation, Sen. Royal Copeland (D-NY) succeeded in getting homeopathic drugs exempted from the usual drug approval process. In those days, FDA only had authority to require safety evaluation, but when an evaluation of efficacy was added—human trials currently cost billions of dollars—homeopathy remained exempt. For anyone who knows anything about homeopathy, this is more than reasonable. Whatever their efficacy, and there is much debate about that, nothing could be safer than homeopathic preparations. Still, it has rankled the FDA not to have authority over this class of medicine, which they would certainly use to remove homeopathic remedies from the shelves. In the eyes of the FDA, it seems that the besetting sin of homeopathic preparations, as with supplements, is that they can under certain circumstances compete with FDA-approved Big Pharma drugs—the very drugs that pay the FDA’s bills, including staff salaries. Are homeopathic preparations unregulated, then? No. Although they do not need to go through the New Drug approval process, they must undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), which involves some clinical verification of the efficacy of the substance. The FDA’s move in the direction of what is probably intended to be tighter control of homeopathy follows several court cases in California a few years ago against Boiron, the world’s leading homeopathic manufacturer. In one case, the plaintiffs alleged that Boiron falsely claimed that its Children’s Coldcalm product would provide relief from cold symptoms. You can read our more detailed coverage of these cases here. But the takeaway is this: in none of the cases did the plaintiffs say they were physically harmed. They merely claim that the products did not treat them as they stated they would, and that they suffered minor economic loss by purchasing the product. (So apparently if your cough medicine doesn’t work well enough for you, you should sue the company!) Care to guess who initiated these cases? Upset consumers—or lawyers calculatedly trying to earn settlement fees? For readers new to homeopathy, treatment is based on the idea that “like treats like.” When you chop a red onion, for example, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in very small doses, Allium cepa is intended to activate the body’s own mechanism for stopping watery eyes and a runny nose. Practitioners of conventional medicine are often hostile toward homeopathy: one commentator called homeopathy “a fraud perpetrated on the public with the government’s blessing.” This kind of response is understandable considering that homeopathic medicine is often so diluted that the original ingredient is virtually undetectable. The mechanism of action is therefore uncertain. But there is scientific support for efficacy, in addition to anecdotal evidence from centuries of use. Here are some scientific studies from the past ten years showing that homeopathy can indeed be effective. These studies—which range from random controlled trials (RCTs, the supposed “gold standard”) to observational studies to meta-analyses—often look at homeopathy as an adjunct to conventional medicine. Here is just a sampling:

• Acute otitis media (when the middle ear gets blocked with fluid and infected with bacteria): a 2012 RCT showed that symptomatic improvement was quicker in the homeopathy group than the conventional therapy group, with a much lower antibiotic requirement.


• Allergies: a 2012 observational study revealed that homeopathy substantially improved allergy symptoms and the dosage of conventional medicine could be substantially reduced; a 2013 study listed the effectiveness of different homeopathic treatments for allergies based on the type of allergy.


• Asthma: in a study of individualized homeopathic treatment, there was evidence that it decreased the severity of asthma in children.


• Other studies show effectiveness of homeopathy for conditions ranging from chicken pox, diarrhea, and in a multi-center observational study, chronic sinusitis. Homeopathy could be an effective treatment for low-grade chronic inflammation, which is the root of many diseases, and could be a complement to conventional anti-tubercular treatment (a finding that is especially important as patients are becoming resistant to TB drugs).


• Further, as our friends at ANH-Europe have reported, the Swiss government reviewed a large body of evidence in 2011­–2012 and found homeopathy to be both effective and cost-efficient.

Much more research is needed despite the abysmal lack of funding for it. At the very least there is promising evidence supporting homeopathy. What we don’t need now is for the FDA to move to shut it down when the industry is already under unfair attack in California. Action Alert! The timing of this is critical—it will be much easier for the FDA to hear us now, before the issue gains momentum. Write to the FDA immediately and tell them that current regulation of homeopathic remedies is more than sufficient to ensure public safety. Please send your message today!

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Federal Dietary Guidelines Being Criticized Even by Government Cronies

Yale scientists don’t get it right either! The Dietary Guidelines Advisory Committee (DGAC), run jointly by the USDA and Health and Human Services, has been working on releasing its 2015 report about what our diet should look like. This is revised and updated every five years. We covered this recently because the committee finally came around to seeing the error in its previous warnings about dietary cholesterol. The committee now admits that “cholesterol is [no longer] considered a nutrient of concern for overconsumption.” The committee’s recommendations, though, seem to have a lot of people upset. The preliminary DGAC report called for a “plant-based” diet, which has the meat industry and some legislators on Capitol Hill up in arms. Other aspects of the report that have drawn attention are measures to promote a “culture of health”—including a soda tax, a dessert tax, and electronic tracking of the use of “screen-based” technologies to deter sedentary lifestyles that lead to obesity. To address these and other concerns about the report, the open comment period has been extended to May 8. And it is clear that any food group (like the meat, soda, or dessert industry) that feels it has been maligned by the DGAC’s guidelines will simply use its considerable influence to get more favorable treatment. It’s next to impossible to avoid crony-capitalist influence over such guidelines—which is one reason the government should not be in the business of telling people what or how to eat. Cronyism isn’t the only problem, though. DGAC is always woefully out of date on nutrition, and not just about cholesterol. One glaring example is vitamin D. DGAC bases its estimates on the amount of essential vitamins we need on the Institute of Medicine’s (IOM) recommended levels, which we’ve shown before to be grossly inadequate. As a point of reference, the IOM now recommends 600 IU (international units) of vitamin D for people between the ages of 1 and 70. Note that the recommendation is identical for people of all ages and weight, which is absurd. The previous recommendation was a mere 200 IU—whereas Harvard and the Vitamin D Council recommend anywhere from 1,000 to 5,000 IU a day. Also of concern is the report’s caution against dietary supplements as a means to achieve their recommended levels, despite supplements’ well-established safety record. The report also advises Americans to reduce their consumption of saturated fat, presumably because of an alleged link to heart disease. Yet more up-to-date evidence shows that saturated fat does not cause heart disease and actually has a number of health benefits. Finally, as mentioned above, the report recommends a diet low in red meat. But, as we’ve shown in the past, not all red meat is created equal: meat from corn-fed, CAFO-raised cows is quite different in nutrient composition than meat from grass-fed, organically raised cows, which is high in healthy omega-3 fatty acids. Rather than telling us what to eat, government at all levels should instead stop gagging free speech about nutrition, an issue we’ve covered extensively in the Pulse of Natural Health. It is absurd, on the one hand, to be subjected to government health guidelines that are obsolete and likely tainted with crony influence, and on the other hand to be prevented from sharing nutrition advice with friends without a special license or consulting the nutritionist of our choice. Nutrition is a science, which means that data and appropriate conclusions are constantly changing. Even some distinguished scientists can get it very wrong. Consider an effort by Yale scientists to create a chart that would rank all foods in general from best to worst. This is very difficult, because all foods have advantages and disadvantages. It only makes things worse if you still labor under the old idea that saturated fat is bad. Let’s look at one example: these Yale scientists say that nonfat milk is “very good” with a high rating of 100, while 2% milk has only a rating of 84, and whole milk has a rating of 52. But cream-topped whole milk at least is more natural and possibly safer, if you can find it non-homogenized (homogenization changes the fat molecules). A recent study also found that consuming high-fat dairy products is linked to a reduction in the risk of developing type-2 diabetes. Other strange outcomes on the Yale list: brown eggs (also linked to reduced risk of type-2 diabetes) are ranked very low with a score of 33, while Pepperidge Farms Whole Grain Bread is ranked higher with a score of 51. Our grade for this whole list is an F. It misleads more than it helps.



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Are We Ignoring the Next Pandemic Risk by Focusing on Measles?

While policymakers and many in the scientific community are worried about measles, a deadlier threat from drug-resistant diseases like tuberculosis lurks on the horizon. Action Alert! The measles outbreak in California has unleashed a storm of heated debate across the country, including multiple calls for mandatory vaccinations at both the federal and state level. What is the extent of this outbreak that has unleashed such energetic debate, you might ask? A total of 178 cases out of a population of 320 million people. While we certainly do not want to disregard the seriousness of measles, there are important questions being asked about the efficacy of the vaccine as well as its safety. And good sense seems to dictate that the response should be proportionate to the severity of the threat. With measles getting all the headlines, there is a much more serious problem that is not getting the attention it warrants. As we’ve reported before, tuberculosis (TB) is one of the world’s most common diseases mainly because it is so highly infectious—it’s spread with a mere cough or sneeze. It’s second only to HIV as the leading infectious killer of adults worldwide. The World Health Organization estimates that two billion people—that’s one-third of our planet’s population—are infected with the bacteria that cause TB. Ten percent of these carriers will become sick, and if left untreated, half of those will die from the disease. TB is becoming resistant to multiple drugs, and many health experts fear it may become “virtually untreatable.” One particularly scary strain of TB, known as XDR-TB (XDR stands for “extremely drug resistant”), has no known cure. The Centers for Disease Control and Prevention (CDC) warns that multi-drug resistant TB is one of our “most significant global threats.” This isn’t just a problem for developing countries, either. Just a few weeks ago, twenty-eight high school students in Kansas were infected with TB. In 2011, the most recent data available, 536 Americans died from TB, and in 2013 there were over 9,500 cases of TB reported. As we’ve shown before, the overarching problem that produces these superbugs is antibiotic overuse—both by doctors who rely too heavily on antibiotics and by industrial farming operations. Consider these statistics: a Medscape poll found that 95% of healthcare professionals said they prescribe antibiotics when they aren’t sure they’re needed. A whopping 70% of all antibiotics used in the US are used on livestock. There’s even evidence that pesticide and herbicide use contributes to antibiotic resistance. As of last Friday, the Obama Administration has released a plan intended to address the issue of antibiotic resistance, but it leaves much to be desired. Much of the plan focuses on heightened surveillance, slowing the spread of drug-resistant bacteria, and developing new antibiotic drugs. These measures are akin to putting band-aids on a gushing wound. To really address this threat, what we need is a shift in thinking about how we treat disease. Fortunately, some health experts are starting to realize the flaw in conventional medicine’s paradigm. Dr. Justin Denholm, an infectious disease epidemiologist at the Royal Melbourne Hospital in Australia, put it this way: “The reality is that this one-size-fits-all approach is a major part of what’s led to this drug resistance issue. I think individualized treatment is what we should be aiming for.” This, of course, is what integrative doctors have been saying all along: the innate effectiveness of drugs diminish over time, and an absolute reliance on drugs is unsustainable. There are other ways to fight disease. Two studies have now linked vitamin D to the successful prevention and treatment of TB. In the first study, white blood cells converted vitamin D to an active form of the vitamin, which helps make a protein that kills the TB bacterium. In the second study, Indonesian scientists compared vitamin D to a placebo, testing them on seventy patients for nine months. The patients who received 10,000 IU of vitamin D (rather than the 600 IU recommended by conventional medicine) led to an astounding 100% cure rate. There have also been studies which show that ozone therapy—which increases the amount of oxygen in the body—can be an effective treatment for TB. There are many other integrative strategies for controlling pandemic bugs. We need these to be ready for the next pandemic. One immediate measure we could take is to support efforts such as the new bill from Rep. Louise Slaughter (D-NY), which would preserve antimicrobial drugs for human use only. That is just a start, but a good start. Action Alert! Tell Congress to support Rep. Slaughter’s Preservation of Antibiotics for Medical Treatment Act, which would reduce the use of antibiotics on livestock and thus take steps towards addressing drug-resistant diseases like TB. Please send your message immediately!

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Waxman Joins Son’s PR Firm

Is Waxman a “liberal icon” who just happened to stage midnight attacks on supplements in conference bills? Or a crony capitalist? We’ll let you decide. Last year, Rep. Henry Waxman (D-CA), the doggedly anti-supplement House member from California, retired from Congress after forty years of service. When we covered Mr. Waxman’s retirement, we saw him as a tragic figure who probably started out with good intentions, even though they led to unintended results. For instance, Mr. Waxman considered himself a strong environmentalist but passed a clean energy bill that ended up being supported by coal companies and opposed by environmental groups. As healthcare legislation emerged in his committee, he once again seemed to have been captured by corporate interests—in this case, health insurers, who were also major campaign contributors to him. Waxman also wanted supplements treated like drugs, even though they can’t be patented, and being non-patentable, nobody will pay a billion dollars to take them through the FDA drug-approval process. Even if supplement prices were raised to drug levels, they would still disappear from the shelves because they lack patent protection. Waxman is very smart. He must have understood all this. Despite his deploying all kinds of cunning maneuvers on Capitol Hill, often in conjunction with Sen. Richard Durbin (D-IL), the other arch-nemesis of supplements, natural health advocates succeeded in outmaneuvering one of Washington’s most clever and powerful players at every turn. While recognizing that DC abhors a vacuum and it was likely someone else would pop up to renew the attack on supplements, it was still a relief to see such a formidable opponent leave office. Now it has been reported that Mr. Waxman has joined his son’s public relations firm in DC, Waxman Strategies. You can guess how and why Waxman’s son got his clients while his father occupied a powerful position in the House. Rumor has it that Waxman senior tried to work at other lobbying firms to avoid the unseemly appearance of joining his son, who had already been profiting from the Waxman name, but found no takers. The former representative is also completing plans to teach at the Johns Hopkins Bloomberg School of Public Health in Baltimore and at UCLA. “I wouldn’t want a firm to represent something I didn’t agree with,” Waxman told the National Law Journal . “There are many special interest groups that I often found myself opposed to in my congressional career.” Will this mean a renewed attack against dietary supplements? Only time will tell.



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GMO Roundup

The GMO labeling issue is seeing some action on Capitol Hill. Maybe that’s because GMOs are in the news across the country. Here are some of the stories you may have missed.

Monsanto Settles with US Wheat Farmers

Monsanto has settled class-action lawsuits with farmers in seven states over 2013 contamination from their genetically engineered “Roundup Ready” wheat. Genetically modified wheat has not been approved in the US, but Monsanto field-tested its Roundup Ready variety between 1998 and 2005 before withdrawing its application for approval from the USDA. Before Roundup Ready was either destroyed or stored, the GM wheat was found on an Oregon farm, triggering a suspension of trade with countries suspicious of GM crops. The incident led farmers in Kansas, Missouri, Illinois, Oklahoma, Texas, Louisiana, and Mississippi to seek compensation for lost income. Now Monsanto has settled these lawsuits by donating $50,000 to agricultural schools in each of the seven states. This is bad—all it does is increase the efforts of these companies to dominate the schools. Last November, Monsanto announced a $2.4 million settlement on other lawsuits stemming from the 2013 Oregon wheat scare.

WHO Report Finds Roundup is “Probably” Carcinogenic

Glyphosate—better known by Monsanto’s trade name, Roundup—is the most widely used pesticide in the country. The World Health Organization’s International Agency for Research, which includes seventeen experts from eleven countries, recently published a report which concluded that, based on animal studies, Roundup is “probably carcinogenic to humans.” Roundup use has increased markedly in recent years, due in large part to the prevalence of genetically modified crops that are “Roundup Ready”—that is, the toxic pesticide can be sprayed on crops, killing weeds without killing the crops themselves. According to the USDA, GM plants were grown on 94% of US soybean fields and 89% of U.S. corn fields last year.

“Arctic Apple” Approved for Sale in US and Canada

The Arctic Apple—a non-browning GM apple developed by the Canadian biotech firm Okanagan Specialty Fruits (OSF)—has been approved for sale in both the US and Canada. What sets apart the Arctic Apple from other GM foods is that the gene which leads to oxidation and browning has been switched off. Most other GM products have been modified by introducing genes from other organisms into a plant. In this context, it is useful to keep in mind that natural tomato plants were selected over the years to eliminate the tendency of the blossom end of the plant to stay green even after the rest of the tomato was red and ripe. After this was done, it was finally realized that the green end was closely connected to flavor, and eliminating the one also eliminated the other. After approval of the GM apple, the OSF president wrote, “Over the next couple of years, we will be working hard with our grower partners to get as many Arctic trees in the ground as we can.” The Organic Consumers Association had petitioned the USDA to deny approval, arguing that the GM apples could be harmful to human health, but the petition was rejected.

Bill Nye Flips on GMOs

Bill Nye, the children’s television show host known most recently for his fierce defense of the science behind evolution and climate change, has flipped his position on GMOs after a visit to Monsanto. Before his visit to the biotech giant, Nye had advised caution in approaching GM foods. He covered GMOs in an episode of his show in 2005 and offered the following advice: “Let’s farm responsibly, let’s require labels on our foods, and let’s carefully test these foods case by case.” He covered the GMO topic again in his recent book, Undeniable: Evolution and the Science of Creation, where he discusses the unintended environmental consequences of GM crops. Now, in a recent backstage interview on Bill Maher’s HBO show Real Time with Bill Maher, Nye stated that he was changing his position and planned to re-write the GMO section of his book. He is reported as having said, “I went to Monsanto, and I spent a lot of time with the scientists there, and I have revised my outlook, and I’m very excited about telling the world.”

GM Grass Gets USDA Seal of Approval

Late last year, the USDA cleared a glyphosate-resistant grass for cultivation without requiring any environmental safety review. Developed by Scotts Miracle-Gro, the grass is a variety of tall fescue turf-grass meant to be marketed to golf courses. The GM grass was developed using a process called “biolistics.” With this method, a gene-gun shoots DNA-coated metal particles into a plant cell. Because this method does not use a plant pest to transfer the genes, the USDA supposedly has no authority to regulate the GM grass and could not direct the Animal and Plant Health Inspection Service (APHIS) to conduct its normal pre-market testing. It’s a clever maneuver initiated by Scotts. In 2003, a variety of GM grass escaped a field trial in Oregon, resulting in a $500,000 civil penalty from USDA. This way there is no oversight—and no potential penalty! Such a tactic sets a dangerous precedent for future efforts to introduce GM products into the market with no testing for negative environmental effects.

“Systematic Corruption” and “Subversion of Science” in the Proliferation of GMOs, Authoritative New Book Finds

Steven Druker’s book Altered Genes, Twisted Truth has recently been released. Druker was part of a 1996 lawsuit against the FDA after the agency decided to allow GMOs to be sold without labels. Now, in this remarkable new work, Druker details how the biotech industry and its well-funded offshoots in government agencies, academia, research institutions, and the biotech industry have succeeded in covering up the evidence that GMOs are not safe and not grounded in sound science. It’s a must-read for those looking to review the evidence in one thorough source.



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

Should we be concerned about radiation from our cell phones (which we carry with us everywhere) and our Wi-Fi (which is nearly ubiquitous these days)? A review of recent studies shows reasons for caution, pointing to evidence which demonstrates that children absorb more microwave radiation (MWR) than adults. The authors also note the shortcomings in current federal regulatory policy in regard to MWR exposure. The study, published in the Journal of Microscopy and Ultrastructure, says that children are at greater risk because their brain tissues are more absorbent, their skulls are thinner, and their relative size is smaller. The younger the child, the greater the risk; fetuses are particularly vulnerable to MWR. To those who follow this issue, the potential dangers of MWR-exposure are nothing new. The UN’s International Agency for Research on Cancer calls MWR a class 2B carcinogen, which means it possibly causes cancer in humans—it’s in the same category as lead, chloroform, gasoline fumes, and the pesticide DDT. Most of the research concerns a specific type of MWR: the radiofrequency electromagnetic fields (RF/EMF) given off by radios, televisions, microwave ovens, cell phones and Wi-Fi, and the smart meters installed in your home by the utility company. As we noted in 2011, there have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs. But after this new study on the MWR dangers to young children, concern is mounting about the growing number of children’s toys that use Wi-Fi technology—and that’s not counting the number of kids who play with tablets or carry cell phones these days. The study also found that adults are at a lower, but still significant, risk, echoing the findings of a 2013 case study from a team of breast cancer surgeons and pathologists who raised the possibility that nonionizing radiation from cell phone EMF exposures caused multifocal invasive breast cancer in four young women. These women, all between the ages of 21 and 39, regularly carried their smartphones directly against their breasts in their bras for up to ten hours a day, for several years. All four developed tumors in areas of their breasts immediately underlying the phones. All four had no family history of breast cancer, tested negative for BRCA1 and BRCA2, and had no other known breast cancer risks. The pathology of all four cases shows striking similarities in the tumor composition. The article concludes with this striking warning: “The risk to children and adolescent from exposure to microwave radiating devices is considerable. Adults have a smaller but very real risk, as well.” Given the potential dangers of long-term exposure to MWR and the near-ubiquity of cell phones and Wi-Fi devices in our society, you might think that significant steps would be taken at the policy level to adequately address these dangers. Unfortunately, that does not seem to be the case. Rather than erring on the side of caution, the US seems to be moving in the opposite direction. The Federal Communication Commission (FCC), the government body responsible for regulating MWR exposure, has stated that equipping schools with Wi-Fi is a national priority; the agency plans to invest an additional $2 billion in broadband service for schools and libraries by the end of the year. The study also notes that exposure limits in the US are inadequate. Exposure limits were set by the FCC in the 1990s, before the plethora of scientific studies showing cancer risks at levels well below the current legal exposure limit. Further, the FCC’s exposure limits are based entirely on short-term exposures, with no consideration of long-term exposures. We now have an abundance of data showing just how dangerous MWR may be. Government warnings have been issued, but according to Forbes , most of the public is unaware of such warnings. Cell phone manual warnings make clear that an overexposure problem exists—but that is to limit legal liability, and besides, who reads cell phone manuals? Furthermore, FCC regulations state that devices should be tested under normal operating conditions—yet many MWR products, including cell phones and laptops, usually measure exposure when the device is held 20 centimeters (a little less than 8 inches) from the body. People place laptops on their laps and keep cell phones in receiving mode (rather than the presumably safe airplane mode) in their pockets and bras all the time. Most people hold their cell phones to their heads to talk, rather than using speakerphone or a headset. Clearly, something needs to be done. The answer isn’t to throw away our cell phones and smash our wireless routers, but in our increasingly tech-intensive world, we need to do a better job of evaluating the risks of moving further and further away from nature. At the policy level, the FCC should update its standards on MWR exposure and test products based on how they are actually used. Government officials in the US could also follow the proactive approach taken by officials in other countries to warn and protect their citizens. Belgium’s Public Health Minister, for instance, banned cell phone sales for children under seven years old. The Australian government produced a fact sheet educating citizens on how they could reduce their exposure from wireless devices. The FCC and other related agencies should work to make sure that people are aware of the possible dangers of MWR exposure. If you are concerned about MWR exposure, there are some simple steps that you can take in your home to protect your family:

• Because of particular dangers to the fetus, pregnant women should avoid exposing their fetus to MWR.


• Avoid using baby monitors on cribs.


• Women and girls should avoid putting cell phones in their bras.


• Hold cell phones 15 centimeters (about 6 inches) away from your ear to limit exposure—that is, use the speakerphone function or else headphones with a microphone.


• When not in use, try not to keep your phone on your person. A cell phone is always radiating unless it’s turned off.


• Teach kids to limit cell phone use when they can, and to use alternatives like landlines and Skype, which don’t emit MWR.


• Wi-Fi routers should be placed where people, especially children, spend the least amount of time.


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


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

In response to public and governmental concern, the World Health Organization (WHO) has established the International Electromagnetic Fields Project to assess the scientific evidence of possible adverse health effects from electromagnetic fields. WHO will conduct a formal risk assessment of all studied health outcomes from RF fields exposure by 2016. Dr. Mercola, in a powerful article on RF/EMF dangers, reported an interesting suggestion from a panel of experts: EMF-free zones where children, pregnant women (or those hoping to conceive), and others sensitive to EMFs, can be protected. It’s an excellent first step for protecting the most vulnerable members of our society. Considering how much wireless technology and other MWR-emitting devices have been woven into our everyday lives, it’s important to act now to protect our family and loved ones.



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Will Google Game the System against Natural Health?

For years, Wikipedia has been a prime source of misinformation (or perhaps disinformation) about natural health. Now we worry about what Google is up to. Action Alert! Our reading of Wikipedia coverage of natural health is that at some point it was captured by interests very hostile to it, as we discussed in depth five years ago. The result is material about integrative doctors and therapies that strikes us not only as highly inaccurate but in some cases libelous. Much of this commentary presents itself as “science.” But as is often the case, people adopting a thoroughly unscientific attitude of mockery and dismissal may try to cloak themselves with the respectability of real scientists. Wikipedia seems to us to be already a major source of misinformation in our field. Could Google being heading in the same direction? Currently, Google’s search engine uses the number of incoming links to a page to determine where it appears in a search. Now, the company is working on a new ranking system based on “truthfulness.” A site with more “incorrect” facts would rank lower than a site that is deemed more credible or trustworthy. This could be quite dangerous. Who at Google decides what is true? Google bias could affect all kinds of issues—from GMO labeling, and integrative approaches to medicine and supplement use, to any stance that challenges mainstream orthodoxies, even when the challenge is thoroughly grounded in the most recent or the most solid science. The software works by tapping into the Knowledge Vault, a database of “facts” that Google has pulled off the Internet. Apparently, if a significant majority of Internet sites agree on a statement, it is considered a reasonable proxy for the truth. Pages that contain contradictory information are bumped down the rankings—which means that anything “alternative” will, by definition, be ranked lower. Google’s ranking system is its own business, but it currently enjoys a virtual monopoly in the field, and needs to stick to a system that is transparently objective. Otherwise, searchers should beware of the gatekeepers who make behind-the-scenes decisions about what information we have access to. New strategies and methods for searching the web would be needed if Google becomes a source of misinformation in our field the way Wikipedia already is. Action Alert! Write to Google and explain how its Knowledge Vault will inadvertently censor research and approaches that are at variance with the mainstream, even if it is supported by the most recent or the most solid science—anything new or challenging will be automatically ranked lower. Please send your message today!

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Once Again, the FDA Deliberately Keeps Us in the Dark About Bad Science

It’s the same old story of prescription drugs and fraudulent studies, but the FDA doesn’t seem to care. Action Alert! A recent article in Slate magazine shows how the FDA hides important safety information when it uncovers scientific misconduct in clinical trials of pharmaceutical drugs. The names of the drugs and the company responsible for the misconduct are concealed, journal citations are left uncorrected, and claims made on drugs’ labels are left unchanged even after it’s known that they were based on bad science. According to the author, “The FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware.” The author notes that these aren’t isolated incidents, but part of routine behavior by the FDA to shield Big Pharma from unwelcome scrutiny. Here are some highlights from the article:

• Out of seventy-eight publications that sprang from a tainted study, only three cases mentioned the problems FDA found in the study.


• Given 600 clinical trials in which a researcher failed an FDA inspection, in only 100 cases could investigators determine which drug and which pharmaceutical company were involved.


• One company, Cetero, was caught faking data from more than 1,400 drug trials that were used to prove the safety of about 100 drugs. Incredibly, after the FDA caught Cetero, the fraudulent data was still on the drug labels.


• In the RECORD 4 drug trials that were used to establish the safety of the anti-blood-clotting drug rivaroxaban, FDA found rampant misconduct, including falsified data and fraud. “Yet,” writes the author, “if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.”

Unfortunately, we’ve seen this kind of thing before. Clearly, there’s a wide gap between what the FDA knows and what doctors and patients are allowed to know about the safety of prescription drugs. This is exaggerated further by publication bias—the tendency of positive results to be published over negative results—which can give doctors incomplete or misleading information about a drug’s safety. Why would the FDA, which is charged with protecting public health, knowingly conceal information about drug safety from the public and the medical community? The answer is simple. In the words of the author, “It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate.” To most of us, the crony-capitalist relationship between the FDA and the pharmaceutical industry comes as no surprise. This is just another example among many of the FDA using its role as a government watchdog to enhance the profits of Big Pharma rather than to safeguard public health. Action Alert! Tell the FDA to require that all drug trials submitted to the FDA be publicly available—not only for new drugs, but for all drugs currently on the market. There is no reason a government agency should bury vital information that could affect the health of its citizens. Tell the FDA to be more transparent! Please take action immediately!

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FDA Compounding Committee Is a Stacked Deck

Conflicts of interests and rampant biases on the committee advising FDA on the new compounding rules? Yes—in abundance! Related Action Alert! Last week, we wrote about the FDA’s latest efforts to regulate compounding pharmacies in its draft Memorandum of Understanding (MOU). Although these provisions are still in the process of being completed, it’s looking increasingly likely that the final rules will severely restrict consumer access to important compounded medications. Why is the FDA proposing to place arbitrary restrictions on the amount of medications that traditional pharmacies can send out of state? To help answer that, you need to look at who is advising the FDA on how to implement new compounding laws. To help them draft new rules, the FDA created a Pharmacy Compounding Advisory Committee. This committee is critical to the development of new rules governing compounding pharmacies, including the development of various lists of drugs that may and may not be compounded, along with lists of which substances may be compounded in bulk. What, then, is the makeup of this committee? It has twelve voting members and two non-voting industry representatives, but there was a troubling lack of transparency in the nomination and selection process. While the FDA reports that it received over 100 nominations from its public comment period, we were unable to find more than just a few of these nominations in the public records. Further, the criteria for selecting among these nominees contain only vague references to the qualifications sought by the FDA, and generic language concerning steps taken to avoid conflicts of interest. According to the FDA, nominees provided “detailed information” in order to “permit evaluation of possible sources of conflict of interest,” but how the FDA actually selected its committee members is largely a mystery. This could help explain the committee’s stunning lack of expertise on compounding. Of the twelve voting members, there are four academics, three government officials (one from the FDA and two from the National Institutes for Health), and three nonprofit representatives. Purportedly representing consumers is Michael Carome of Public Citizen, who made his intentions known from the beginning: “As the consumer representative on the FDA’s Pharmacy Compounding Advisory Committee, I intend to aggressively advocate for rigorous FDA safety standards for all compounded medications to protect patients from serious harm.” Can we expect his vote to be based on an objective analysis of the facts, or fueled by a desire to see FDA be as aggressive as possible in restricting the compounding industry? A second nonprofit committee member is from the Pew Charitable Trusts, another politically engaged advocacy organization. It deals generally with some public health issues but is hardly qualified to make technical judgments on which specific drugs are suitable to be compounded or not. Of the two non-voting industry representatives, only one is actually a compounder. The other is a representative of Regeneron Pharmaceuticals, which is an interesting choice by FDA given the firm’s elephant-sized conflict of interest. Regeneron makes a drug, Eylea, to treat age-related macular degeneration. The competition, a drug called Avastin, is a compounded drug that is far cheaper. If Avastin, or any other compounded drug that competes with a pharmaceutical, becomes more difficult for doctors and patients to acquire, the market share of Pharma firms increase. How FDA came to approve this Regeneron member with such a clear conflict of interest defies logic. Out of fourteen committee members, then, only one seems to be an expert on compounding specifically, rather than pharmacology in general, and that committee member can’t even vote. The other non-voting member is from a drug company with a clear conflict of interest, and one (voting) member is from an advocacy group with a clear bias against the compounding industry. The committee is clearly stacked against those who stand to lose if access to important medications is restricted. The committee membership explains, at least in part, some of the arbitrary and needlessly restrictive rules being pursued by FDA. The fact that FDA relies heavily on funding from Big Pharma is certainly relevant as well. We will continue to closely monitor what comes out of FDA and the Compounding Advisory Committee, but given developments so far and the bias of the committee, the prospects look somewhat bleak. Related Action Alert! FDA just reopened public comment as they draft their new compounding rules. Send a comment and tell FDA to maintain consumer access to important compounded drugs! Please take action immediately!

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Supreme Court Decision Deals Blow to Monopolistic State Medical Boards

Bad news for trade-restraining state medical boards, good news for consumers in teeth-whitening case. Related Major Action Alert! On February 25, the US Supreme Court ruled that North Carolina’s dental board violated antitrust laws by shutting down hair salons and day spas that offered teeth whitening services. According to the Wall Street Journal , “The decision preserves the power of antitrust enforcers to scrutinize professional licensing organizations, even if they are designated as state-government entities.” The dental board had claimed they were exempt from antitrust law because they were a government body, but the court found that the board was acting without proper state supervision. Writing for the court, Justice Kennedy stated that antitrust law “does not authorize the states to abandon markets to the unsupervised control of active market participants, whether trade associations or hybrid agencies.” You can see our earlier coverage of this case for more background. This ruling is a clear message of caution to all state medical boards that use their power to protect their monopoly on the practice of medicine, typically to the detriment of CAM doctors. Take, for instance, the state of Washington’s Medical Quality Assurance Commission (MQAC), a state board infamous for its malicious treatment of integrative physicians. We have recounted MQAC’s ongoing attacks against integrative medical practitioner Dr. Jonathan Wright. In the most recent case, Dr. Wright’s Tahoma Clinic had hired a medical doctor who had been licensed in another state, under the condition that he apply for a Washington medical license. He did so, and the doctor’s Washington license was listed as “pending” on MQAC’s website. During this period, Dr. Wright followed the legal advice he had received and monitored him closely as required by Washington law. Suddenly, MQAC charged Dr. Wright with “aiding and abetting the unlicensed practice of medicine” because the doctor’s out-of-state license had been revoked! To add insult to injury, it soon became known that at least four MQAC staff members knew from the beginning that the doctor’s out-of-state license had been revoked and that he could therefore not be licensed in Washington, but they never put that information on the MQAC website or made any effort to inform Dr. Wright. It seems apparent that the intent was to entrap Dr. Wright by denying him any information. Sadly, this is just one example among many of MQAC harassing integrative doctors. Examples abound where infractions by conventional doctors are overlooked entirely or given a slap on the wrist by MQAC and other state medical boards. When integrative doctors engage in similar behavior, however, MQAC throws the book at them. This Supreme Court ruling offers hope to consumers, practitioners of integrative medicine, and all who oppose monopolies in healthcare—monopolies that usually have nothing to do with protecting public health and everything to do with protecting turf. That is why various nurses’ groups opposed the NC medical board. The Academy of Nutrition and Dietetics (AND) has also been at this game for a while in its efforts to pass “scope-of-practice” laws whereby only Registered Dieticians (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. We can only hope that this Supreme Court decision serves as a precedent— not only for monopolistic state medical boards across the country, but for state nutrition/dietetics boards as well. The recent victory of Steve Cooksey in North Carolina offers another glimmer of hope that governmental and legal bodies are starting to crack down on medical and nutritional monopolies, and we at ANH-USA applaud these actions. Related Major Action Alert! Last week, we wrote about the new model legislation let loose in over a dozen states by the Federation of State Medical Boards (FSMB). The legislation is an underhanded way for the FSMB, a private organization with no public funding, transparency, or accountability, to extend its power and supersede state rules governing medical licensure. Click here to see if your state is considering this legislation and tell your legislators to reject it! Please send your message immediately!



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New Power Grab by Federation of State Medical Boards Threatens Integrative Medicine

Legislation that has been introduced in fourteen states must be stopped now. Major state-based Action Alerts! Back in September 2014, the Federation of State Medical Boards (FSMB) released model legislation for the creation of an interstate medical licensing compact. The stated intent of the legislation is to streamline the licensing process for physicians who wish to apply for medical licenses in multiple states. According to Medscape , the model legislation would allow physicians to apply for an expedited license “in a state other than their own without filling out another formal application or providing another set of documents to the other state’s board. If they meet the eligibility requirements specified in the compact, the board in their ‘principal state’ of license can attest to their qualifications, and the second state can license them.” The compact would take effect only after at least seven states approve the legislation. Once enacted, an Interstate Commission comprised of representatives of each member state would be created to administer the interstate medical licensing compact. This may look like an innocuous or even useful move by FSMB, but a deeper analysis of this proposal reveals that the opposite is true. The FSMB—a private trade association that sets standards which are often followed by state medical boards—has historically been no friend to integrative medicine. Despite having no public funding, transparency, or accountability, FSMB wields a tremendous amount of power over the practice of medicine in all fifty states. The organization has demonstrated its antipathy toward natural health since the mid-1990s, when it discussed altering the definition of health fraud to include alternative medical care! It would appear that FSMB considers innovative approaches to healthcare to be nothing more than exercises in “quackery.” Operating in the dark as it does, it is hard to say who is running the organization or setting its agenda. But we suspect, based on the available evidence, that it is funded and controlled by some combination of the American Medical Association and Big Pharma. If so, it is one of the chief forces behind the kind of corrupt crony medicine we see today. At the very least, states should be wary of following the FSMB’s lead, much less ceding their power to an organization with so little transparency and public accountability. FSMB claims its proposal “reflects the effort of the state medical boards to develop a dynamic, self-regulatory system of expedited state medical licensure over which the participating states maintain control through a coordinated legislative and administrative process,” and is therefore the “ultimate expression of state authority.” Such a claim, however, is frankly not credible—especially considering that the language of the compact clearly states that rules made by the Interstate Commission would have “the force and effect of statutory law in a member state.” The Missouri Board of Registration for the Healing Arts echoed these concerns, noting that the Compact [takes] away the state’s autonomy and authority to grant licenses.…If [an] applicant is deemed “compact eligible” by any other compact state, all member states must grant licensure based on that eligibility. There is no discretion to look at moral character, malpractice history, training irregularities, or other requirements. There is also no opportunity for a state to disagree with another state’s interpretation of the compact requirements or their determination that a particular applicant meets those requirements. In other words, contrary to FSMB’s claim elsewhere, the interstate compact clearly takes power away from the states. There is a stunning lack of accountability with the FSMB-created Interstate Commission. While we’ve been critical of the actions of some state medical boards, at least there is some degree of process by which the public can weigh in when rules are created. But when one bad rule can affect at least seven different states, how can the public have any input? Considering FSMB’s record of enmity toward integrative medicine, we should be extremely wary of its proposal. Another worrisome aspect of FSMB’s interstate compact is its Maintenance of Certification (MOC) requirements. FSMB would require physicians seeking a license through the compact to participate in a credentialing process overseen by one of twenty-four approved medical specialty boards of the American Board of Medical Specialties (ABMS). While ABMS argues that its recertification process maintains high standards, many physicians see this as little more than a money-making endeavor for ABMS—in fact, the chair of ABMS makes $1,000 a day. Worse, these certifications are often used as a requirement for hospital employment. As with monopolistic nutrition licensure laws, FSMB’s interstate compact could be a similar attempt to exercise undue control over the practice of medicine. As the Association of American Physicians and Surgeons notes, the compact “would be a giant leap towards entrenching MOC as mandatory for ALL physicians and [would put] in place a new bureaucracy that will most certainly only continue to increase its power over the ability of physicians to practice and the rights of patients to see the physician of their choice.” In short, FSMB’s proposal is an underhanded attempt to increase its control over the practice of medicine—power that would likely be wielded against integrative doctors. Currently, fourteen states have introduced FSMB’s model legislation. We must vehemently oppose this legislation wherever it pops up. You may be wondering if it’s even legal for a state to delegate authority to a private organization. It seems that the answer depends on the state. Some states are strict and permit delegation of authority only if the delegating statute provides definitive standards or procedures. Other states with looser standards find the delegation of legislative power okay if the recipient has adequate procedural safeguards. Political philosopher John Locke argued centuries ago that no legislature can legitimately delegate its power of legislating to any other body. The founders of our country thought they were incorporating this principle in our Constitution. Alas, we have increasingly deviated from this basic English and American common-law principle. Major Action Alert! Tell your state legislature to reject the FSMB’s legislation. It would cede state licensing power to an unaccountable Interstate Commission controlled behind the scenes by a private organization, and it would force many physicians to participate in a burdensome and costly recertification process. Please send your message immediately! Idaho residents, click here. Illinois residents, click here. Iowa residents, click here. Maryland residents, click here. Minnesota residents, click here. Montana residents, click here. Nebraska residents, click here. Oklahoma residents, click here. Rhode Island residents, click here. South Dakota residents, click here. Texas residents, click here. Utah residents, click here. Vermont residents, click here. West Virginia residents, click here. For all other states, click here.



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Will We Allow Big Pharma to Patent and Control Natural Products?

Behind the scenes, the pharmaceutical and biotech industries are trying to change the law—to benefit no one but themselves. Major Action Alert! Big Pharma in general—and biotech in particular—are having trouble coming up with new-to-nature molecules they can successfully patent and turn into blockbuster medicines. They know the healing power of natural substances. But natural substances are not supposed to be patentable. Or if they are patentable because a new process is involved, the patent protection may be weaker. As we have noted many times, drug companies are not interested in medicines that cannot be patented or that hold weak patent protections, because they don’t earn enough money for the substances to be taken through the multi-billion-dollar FDA approval process and thereby gain a complete government-enforced monopoly, which brings with it the power to charge huge sums for the product. Now they’re trying to get the US Patent and Trademark Office (USPTO) to change patent law about natural substances. Pharma and biotech companies were dealt a blow in their efforts to “patent nature,” as it were, when the US Supreme Court struck down patents on human genes in 2013. In its decision, the court wrote that Myriad Genetics, the private company seeking a patent on two genes which account for most inherited forms of breast and ovarian cancer, “did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” ANH-USA strongly supported this decision. If Myriad’s patent claims were upheld, it would have meant that they had ownership over particular genes in the human body. Patents on these genes would keep competitors from offering similar genetic tests, which restricts market competition—which in turn decreases prices, increases access, and improves the tests themselves. It would also cut off scientific research: scientists outside Myriad couldn’t study these genes without Myriad’s permission. The Supreme Court’s decision led USPTO to tighten its restrictions somewhat on patenting natural products. According to an article in Science Magazine , this infuriated biotech firms, which contended that the new restrictive approach would discourage investment and innovation. Now, apparently in response to industry pressure, USPTO has promised to rethink its approach. In its reappraisal, USPTO is considering a different framework to determine the patentability of products of nature. If a patent claim describes “a law of nature, a natural phenomenon, or an abstract idea,” it must amount to “significantly more” than what is found in nature to be eligible for a patent. In the same Science Magazine article, one expert noted that this framework gives examiners “multiple criteria for deciding whether a product is sufficiently different from its natural counterpart: ‘structure, function, and/or other properties.’ [He] suspects that this vague language could lead to fewer eligibility-based rejections” (emphasis added). While there is still a great deal of uncertainty about which guidelines will finally be adopted and how USPTO will interpret and apply them, the change in rules would clearly open up new pathways for Big Pharma and biotech firms to patent natural substances. This is just the latest of many efforts to patent nutrients and natural substances. We’ve seen numerous attempts by drug companies, for instance, to monopolize previously affordable substances (like bioidentical estriol and 17P) and then jack up the price. In the case of 17P, a substance that helps prevent premature births, the price skyrocketed from $10 a dose to $1,500 once KV Pharmaceutical was granted exclusive rights by the FDA through the Orphan Drug Act. And it doesn’t stop there: Big Pharma has also tried to steal natural supplements. Pyridoxamine—one of only three natural and bioavailable forms of vitamin B6—inhibits aging and disease progression. In fact, B6 is necessary for life itself—we die without it. FDA banned pyridoxamine in 2008 in response to a petition from a drug company that wanted to use it in their own drug formulation. Another drug company is looking to snatch up P5P (pyridoxal-5’-phosphate), another natural form of vitamin B6. Their attempt has been unsuccessful—so far. If patent laws are weakened, we can expect an increase in efforts by Big Pharma to gain exclusive rights over natural supplements. USPTO is accepting comments on its proposals until March 16. Major Action Alert! Tell USPTO to keep restrictions in place that prevent natural substances from being patented. Please send your message immediately—the time is short!

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