The Alliance For Natural Health

Analysis

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The FDA Death Meter offers hard statistics on deaths and illnesses from FDA-approved drugs, vaccines, and medical devices. But what of less-quantifiable injuries? Through the FDA’s censorship and obstruction of good science, its support of GMOs and dangerous additives, its approval of drugs that cause or exacerbate other illnesses and conditions, and its rejection of natural health options, the FDA is responsible for hundreds of thousands of additional deaths. Unfortunately, this only begins to describe the depth of the problem.

Take heart disease, for example—the number one killer in America according to the CDC, killing 614,348 people a year. Not only has the FDA helped cause the epidemic of heart disease in the United States, it has approved deadly drugs to treat it and blocked consumers from learning about the benefits of natural substances that could help prevent it.

How many heart attacks could have been prevented if people knew of the benefits of vitamin D, magnesium, and fish oil for heart health—and how many could have been prevented if the FDA didn’t cave to Big Food in its approval of partially hydrogenated oils, its stance on added sugar, and its definition of “healthy”?

Our rough estimation is that the FDA’s mistreatment of the epidemic of heart disease has led to an additional 6,416,000 deaths over two decades.

Adding to the Problem

Recall that the mission of the agency is to protect the public health by ensuring the safety and efficacy of drugs and our nation’s food supply (among other things). Even though we know that poor diet and lifestyle are major contributors, the FDA has repeatedly ignored the most current science and imperiled the health of this nation.

Partially hydrogenated oils (PHOs) and artificial trans fats

PHOs have been around since the early 1900s when a German chemist found that liquid vegetable oils could be made solid or semi-solid by being treated with hydrogen gas. These fats—which include margarine, shortening, and other frying oils—were not only cheaper but for many years thought to be healthier than animal fats such as butter, beef tallow, or lard.

In the 1970s and 1980s studies started to emerge suggesting that PHOs promoted heart disease, yet the FDA did nothing. In fact, the agency commissioned its own reviews in 1976 and 1985, which found that PHOs were not harmful.

By the early 1990s clinical research was conclusively demonstrating that trans fats (which are byproducts of PHOs) and PHOs increased the risk of heart disease. A Harvard study published in the New England Journal of Medicine estimated that trans fat was causing between 72,000 and 228,000 coronary heart disease events each year—and 50,000 premature deaths.

What was the FDA’s response to this public health crisis? Almost a decade later, in 1999—after an additional 500,000 deaths, if we accept the Harvard researchers’ estimates—the FDA proposed to list trans fat content on Nutrition Facts Labels. This rule wouldn’t go into effect until 2006, translating into another 350,000 deaths until the FDA forced companies to simply list the trans fat content in food.

It wasn’t until 2015 that the FDA finalized its determination that PHOs are not generally recognized as safe, giving the food industry three years to remove PHOs from their products.

In the 22 years it took the FDA to act on the hard evidence that PHOs were killing people, we can estimate that 1,100,000 people died from heart disease and millions more suffered from other coronary heart disease events.

Added sugars

Evidence has been mounting for some time that sugar is another major killer in the US:

  • A 2013 report found that up to 40% of US healthcare expenditures are for diseases related to the overconsumption of sugar such as heart disease, diabetes, stroke, cancer, and coronary artery disease.
  • Clinical trials have shown that those who consume high-fructose corn syrup develop higher risk factors for cardiovascular disease in just two weeks.
  • A study published in the Journal of the American Medical Association found that the average American gets 25% of their daily calories from sugar, which triples the risk of dying from heart disease
  • Sugar impairs cognitive ability and prevents healing after brain injuries. (There’s much more, but listing all the negative health effects of sugar would fill many pages.)
  • Sugary drinks alone have been estimated to cause 25,000 deaths each year.

An agency dedicated to protecting public health might consider taking steps to address this problem, but as we’ve seen with PHOs, the FDA’s record so far has been deplorable.

In 2015 the agency announced its intention to revamp Nutrition Facts labels for packaged foods. The final rule included a 10% daily recommended value (DRV) for added sugars. This means that, in the opinion of the FDA, the daily intake of calories from added sugars should not exceed 10% of total calories. Their “general nutrition advice” is 2,000 calories a day for adults and children 4 and above (meaning that, according to the government, a 5-year-old girl and an athletic 25-year-old man should both be fed the same amount). Under this new rule, each should also consume 50 grams of added sugars every day. For children under 4, who might get 1,000 calories per day, this is 25 grams of added sugar.

This rule was a 180 turn from the agency’s previous determination that there was no “sound scientific basis for the establishment of a quantitative intake recommendation [from]which a DRV could be derived.” This was correct: to imply that we need any amount of added sugar is false and misleading.

Now the agency apparently thinks there is indeed a “sound scientific basis” for eating processed food that contains 200 calories of high fructose corn syrup every day, in addition to whatever sugars are already in the food naturally. Food companies, and of course the general public, will regard this DRV as a recommendation to consume added sugar!

How many more people will die as a result of the agency’s inaction? Certainly a 10% DRV will do very little to address the 25,000 people that die from sugary beverages each year.

Definition of “healthy,” and the low-fat myths

For years now, we’ve known that the “low-fat” craze starting in the 1950s was based on bad science. The most up-to-date research has repeatedly shown that certain saturated fats and cholesterol are actually critical to human health and are not linked to heart disease.

The low-fat myths spawned an entire industry of unhealthy products. Egg beaters, for instance—which are egg whites with additives—were hailed as a healthy substitute for eggs, even though we know that whole, free-range eggs are one of the best sources of vital nutrients like cholesterol and biotin. Healthy fats are the building blocks of cell membranes and hormones and also serve as carriers for fat-soluble vitamins like A, D, E, and K.

The FDA, and most other government agencies for that matter, remain woefully behind on this science and seem committed to perpetuating the low-fat myths that are perpetuating the poor health of this country.

Up until 2016, FDA guidelines stipulated that a food must be low in fat to be labeled “healthy.” This made news when the agency ordered the KIND company, known for its fruit-and-nut bars, to stop calling some of its products “healthy”—even though most of the saturated fat in the bars comes from almonds, cashews, and peanuts! In 2016 the FDA seemed to back down as they started a reevaluation of their definition.

Even so, the low-fat myths continued in the government’s updated Dietary Guidelines for Americans released in 2015. The Guidelines, created by a panel of scientists and members of government agencies including the FDA and the USDA, included recommendations to, once again, reduce consumption of saturated fat and cholesterol.

Americans who follow this poor, scientifically unsupported advice will likely continue to experience many of the same bad health outcomes that have been plaguing the country for decades. Once again, the results of this poor decision-making are not reflected in the official estimates made on the home-page of this website—meaning that the death toll that results from the FDA’s actions (or inaction) is quite a bit higher.

Deadly Solutions

The FDA’s contribution to the epidemic of heart disease notwithstanding, the agency also fails to adequately help those seeking solutions.

Statins

Based on the erroneous belief that cholesterol is the primary factor in heart disease, pharmaceutical companies developed statin drugs to reduce the risk of heart disease. The drugs, which have been accompanied by massive marketing campaigns, are huge moneymakers for the drug industry, to the tune of about $29 billion worth of sales in 2013. That’s the kind of outrageous money you make when you convince one in four Americans over the age of 45 to take statins.

Unfortunately, a number of studies have shown that statins can cause a wide variety of negative health outcomes:

  • Statins interfere withthe production of coenzyme Q10, which supports the body’s immune and nervous systems, boosts heart and other muscle health, maintains normal blood pressure, and much more.
  • Statinsweaken the immune system, make it difficult to fight off bacterial infections, and increase the production of cytokines, which trigger and sustain inflammation.
  • They make some patients unable to concentrate or remember words, and are linked to muscle and neurological problems, includingLou Gehrig’s Disease.
  • Statins inhibit the beneficial effects of omega-3 fatty acids by promoting the metabolism of omega-6 fatty acids, whichincreases insulin resistance and the risk of developing diabetes.
  • There is evidencethat statin use blocks the benefits of exercise. Exercise increases the activity and numbers of mitochondria, cells’ “power plants” that process sugars and fat. The study found that with statin use, mitochondrial activity actually decreases with exercise.
  • Statins work by reducing the body’s ability to produce cholesterol, which isessential to brain health—the brain is 2% of the body’s weight, but contains 25% of the entire body’s cholesterol.
  • Statin users have a higher incidence ofnerve degeneration and painmemory lossconfusion, depression, and a higher risk of ALS and Parkinson’s, according to Dr. David Williams in his July 2014 Alternatives newsletter. Statins also decrease carotenoid levels. Carotenoids, which are found in fresh fruits and vegetables and act as antioxidants, have a number of benefits, including protecting against cell damage, aging, and chronic diseases.
  • Statin drugs may also be driving Americans to overeat:a twelve-year study published in JAMA Internal Medicine found that statin users increased their calorie intake by 9%, and fat consumption by 14.4%, over the study period, whereas those who didn’t take statins didn’t significantly change in either measure.
  • An animal studylinked statin use to muscle damage. Animals that exercised on statins had 226% more muscle damage than those not given statins.
  • They affect thequality of sleep.
  • Statins increase the risk ofprostate and breast cancer.
  • Statins are known tocause liver damage by increasing the liver’s production of digestive enzymes.
  • Statins alsospeed aging and lower sex drive.
  • Statins have been linked toaggressive and violent behavior in women.

Despite the staggering number of dangers associated with statins, the FDA continues to advocate for their use.

NSAIDs

NSAIDs (non-steroidal anti-inflammatory drugs) are a class of drugs used to relieve mild to moderate pain related to a variety of conditions. They are some of the most widely used drugs in the US.

Low-dose aspirin (one of the most common NSAIDs) is often used to reduce the risk of heart attack in high-risk patient populations. Many patients must take NSAIDs for a year or more after an angioplasty (see below) to guard against blood clots.

Despite their widespread use, especially chronic use in treating and preventing cardiovascular events, NSAIDs can be extremely dangerous. NSAIDs work by inhibiting certain enzymes that synthesize pro-inflammatory molecules. This can reduce inflammation but also can negatively affect other parts of the body:

  • Gastrointestinal toxicity. NSAIDs inhibit the production of molecules that aid in the production of the lining that protects the gastrointestinal tract from stomach acid. This can cause heartburn, nausea, abdominal pain, ulceration, and bleeding.
  • Cardiovascular toxicity. NSAIDs can also increase in blood vessel constriction, which leads to hypertension and renal failure. The drugs can also impair the removal of excess cholesterol from blood vessel walls.
  • Kidney toxicity. Long-term NSAID use can wreak havoc on the kidneys, leading to impaired glomerular filtration (the process by which the kidneys filter the blood), renal tubular necrosis, and even renal failure.
  • Mitochondrial dysfunction. NSAIDs can interfere with the mitochondria’s production of energy, resulting in the release of higher than normal levels of free radicals.

Side effects from NSAID use are not uncommon: there are about 107,000 hospitalizations and between 3,200 and 16,500 deaths from NSAID-related gastrointestinal complications each year from arthritis patients alone.

Vioxx alone, the infamous NSAID approved by the FDA despite foreknowledge of its propensity for causing heart attacks, killed 60,000 people and caused 140,000 heart attacks before it was pulled from the shelves. This scandal, perhaps the largest in FDA history, is covered in more detail elsewhere on this site.

Unnecessary surgical procedures

Other approved treatments for heart disease and related conditions are just as dangerous.

Lap-band surgery has become increasingly popular as a way to fight obesity and prevent heart problems. A silicone device is placed around the stomach and is meant to reduce the amount of food the patient consumes. Part of the reason for the rise in popularity of this surgery is that the FDA expanded the pool of eligible individuals for the surgery from just those that are “morbidly” obese (a body mass index (BMI) of 40 or above) to those who are just barely obese (a BMI of 30, the minimum threshold to be considered obese).

The problem is the surgery is both dangerous and ineffective. One study followed those who had the surgery for 10 years and found that in one out of three patients the band eroded and 60% had undergone additional weight loss surgery. The report concluded that the surgery “appears to result in relatively poor long-term outcomes.”

There are also a scary list of side effects for lap-band surgery including vomiting, gallstones, constipation, difficulty swallowing, gastric perforation (tearing of the stomach wall), pancreatitis, and more.

Another common procedure is an angioplasty, a procedure that involves inflating a thin balloon in an artery to remove deposits and leaving a stent behind to keep the artery open. About 600,000 are performed each year.

Angioplasties can save a patient’s life in the midst of a heart attack, but often the surgery is unnecessarily performed on patients that have not had cardiac events.

Angioplasty does not prevent heart attacks or prolong survival. In patients with stable heart disease, lifestyle changes are often the best treatment, yet less than half of these patients are treated with lifestyle changes before given an angioplasty. In fact, one study concluded that angioplasty offers no benefit compared to less invasive treatments for heart disease.

This is crucial because angioplasty comes with significant risks, including blood clots, stroke, coronary artery damage, kidney damage, and death—all while doing nothing to address the underlying causes of heart disease. In 40% of angioplasties without stents, the patient’s artery re-narrows—meaning the surgery was all for nothing. About 5% of people suffer complications during the surgery including bleeding, blood clots, infection, heart rhythm disturbances, and even death from heart attack.

 

Blocking the Real Solutions

That the FDA-approved solutions to heart disease are so dangerous wouldn’t be such a problem if the agency wasn’t also actively undermining safe and effective natural solutions to heart disease.

Gagging free speech

As we’ve explained elsewhere on this site, the FDA and FTC heavily censor what natural health companies can say about their products. We know, for example, that fish oil has extraordinary health benefits such has promoting heart health, but fish oil supplements cannot make disease claims, which are reserved for drugs that have gone through the FDA’s costly drug approval process. Other claims that can be made can only be general and vague and must come with a caveat on the label: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

Consumers, then, are denied important scientific information regarding natural health products, and are left to assume that dangerous pharmaceutical drugs and invasive surgeries are their only options—which simply isn’t true. Fish oil, for instance, has been shown to reduce triglyceride levels, an important risk factor for heart disease.

Nutrient deficiencies unaddressed

Vitamin D deficiency has also been linked to cardiovascular disease. Vitamin D has been found to help reduce inflammation, normalize blood pressure, and improve insulin sensitivity—all factors that reduce heart disease risk. Unfortunately, an estimated three quarters of American teens and adults are vitamin D deficient.

Part of the problem is that companies selling vitamin D supplement cannot advertise the scientifically demonstrated health benefits of the product. Another problem is that the FDA has set embarrassingly low daily value for vitamin D at 400 International Units (IU) per day. The National Academy of Medicine’s (formerly the Institute of Medicine) recommended daily allowance (RDA) for vitamin D is 600 IU per day. (Note: The RDA is how much of a nutrient the government thinks you should get each day; the daily value is how much of a nutrient a serving of a food or supplement provides in the context of a total daily diet.)

Studies have shown, however, that these vitamin D levels are far too low. Two groups of researchers found an error in the calculation made by the National Academy of Medicine that threw off their result by a magnitude of ten—meaning that, if the researchers are correct, the real amount of vitamin D needed to cut incidences of disease is between 6,000 and 7,000 IU per day. (To determine what level is best for you, you should consult with an integrative physician skilled in natural medicine.)

By setting the recommended levels of vitamin D so low, the FDA is helping to keep the population from getting enough of this vital nutrient. And make no mistake; this is a life or death issue. A 2008 study found that men with low vitamin D levels suffered almost two and a half times more heart attacks. About 157,000 Americans die from coronary heart disease-related heart attacks. Based on the 2008 study, 92,500 lives could be saved every year if Americans optimized their vitamin D levels.

Magnesium deficiency is another commonly overlooked risk factor in heart disease. Magnesium is crucial for blood pressure regulation, normal heart contractions, and blood vessel function, but almost half of the US population is magnesium deficient. Research has demonstrated that low magnesium intake increases the risk of developing heart disease. Like vitamin D, some estimate that we may need almost three times more magnesium than what the government recommends. One calculation attributes more than 148,000 deaths each year to magnesium deficiency.

Like fish oil, vitamin D and magnesium supplements cannot make any claims about treating or preventing heart disease, even though lots of scientific evidence supports these claims.

Conclusion

The number of deaths from FDA-approved products is staggering, but even these numbers only scratch the surface. When we consider the FDA’s approach to a chronic killer like heart disease, we see that many, many more Americans are becoming sick and dying as a result of the agency’s ineptitude, short-sightedness, and bias toward pharmaceutical drugs and invasive surgeries.

PHO’s caused 50,000 premature deaths each year for 22 years (a total of 1,100,000 deaths) as the FDA considered the evidence proving they were causing harm.

We can be sure that a 10% DRV for added sugar that the agency approved in 2016 will do very little to address the 25,000 people that die from sugary beverages each year.

How many deaths have been caused by the FDA’s refusal to acknowledge the role that vitamins and minerals play in disease treatment and prevention? When we consider the deaths caused by key nutrient deficiencies (148,000 a year for magnesium, and that 92,500 lives could be saved if proper vitamin D levels were reached), the numbers could be staggering: (148,000 x 22) + (92,500 x 22) + 25,000 + (50,000 x 22) = 6,416,000 additional deaths** for which the FDA is at least in part responsible.

Keep in mind that this is just for heart disease. If we apply the same analysis to other conditions like diabetes, Alzheimer’s, or cancer, these numbers will climb still further.

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**Note: The 22 refers to the 22 years the FDA neglected to address the problem of PHOs. The 25,000 death total from sugary sodas was not adjusted like the others because the FDA finalized its added sugar rule in 2016 (the time of this writing).

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