Un-Health and the Crisis of Modern Civilization

By James J. Gormley

The modern healthcare crisis is a modern crisis in health, first and foremost, before we even get to access to the question of “care.”

To put this point in perspective, let’s take a step back to late 2010, when British researchers published their examination of nearly 1,000 mummies from ancient Egypt and South America. They found that only a few of these ancients suffered from cancer before they died.

The findings suggest that cancer is not a naturally occurring condition and that modern lifestyles and industrial pollution are the main cause of the 33 percent cancer rate seen in the industrialized world today.

In an October 2010 article in England’s The Telegraph, Dr. Rosalie David, a biomedical Egyptologist said that in ancient times, cancer was extremely rare. “There is nothing in the natural environment that can cause cancer, “ said David. “So it has to be a man-made disease, down to pollution and changes to our diet and lifestyle—cancer appears to be a modern disease created by modern life.”

Since the life expectancy of people in the ancient world was between 25 and 40, we might attribute the low incidence of cancer to the abbreviated lifespan — for example, if certain cancers take 25 to 30 years to develop then it would be expected that the incidence of cancer would be low. That might have held water except for the fact that the main reason the life expectancy estimates were so low was because the infant mortality rates were so high: as high as 30 to 40 percent.

The Discouraging News in 2011

It is known that breast, prostate and colorectal cancers are increased in certain societies, such as the U.S., and it is believed that this is partly due to the fast food consumption in this country in comparison with diets rich in fiber, seafood, lean meat, vegetables and fruit.

In the U.S., breast cancer hit about 208,000 women last year, and it was estimated that 39,840 women would die from it. Colorectal cancer, which is perhaps the type of disease most closely linked to dietary choices, killed 51,370 people in 2010. In terms of incidence, there were 101,700 new cases of colon cancer last year and 39,510 new cases of rectal cancer.

Smoking is linked to cancers of the lung, bladder, mouth, colon, kidney, throat, voice box, esophagus, lip, stomach, cervix, liver and pancreas.

In terms of lung cancer, there were 222,520 new cases in 2010 and approximately 157,300 deaths, making lung cancer the leading cause of cancer death by far, accounting for nearly 30 percent of all deaths from cancer.

In terms of cancers with a strong environmental/industrial exposure component, while asbestos is linked primarily to lung cancer, exposure to benzidine (a chemical found in certain dyes) is mainly associated with bladder cancer.

Diabetes, Heart Disease and the Quality of Life Killers
Moving outside the realm of cancer, type 2 diabetes, of course, is largely caused by lifestyle choices, such as diet and physical activity. Type 2 diabetes, in which the body gradually loses its ability to use and produce insulin, accounts for 90 to 95 percent of cases.

Although diabetes kills less people, nearly 26 million Americans (or nearly 8 percent of the population) have diabetes and 79 million people have pre-diabetes. People with diabetes can experience numerous serious and deadly complications, including heart disease and stroke, blindness, chronic kidney disease, and amputations.

The no. 1 killer, of course, is heart disease. Clocking in at 26.8 million non-institutionalized people with diagnosed heart disease, heart disease kills 616,067 people each year.

What makes matters even worse, 33 percent of adults have hypertension and 15 percent have high cholesterol. Nearly 70 percent of Americans are overweight or obese. Add these factors together, and stroke may be in the picture, which by itself strikes down 135,952 people a year.

Quality of Life Indicators
And the discouraging news is not only about killer diseases; it’s also about conditions that impact our quality of life, that hobble us with all of the pains and aches that can make living feel like a torture.

Arthritis is one such quality-of-life killer, one which is diagnosed in 52.1 million people. Other critical, life-impacting conditions and areas for concern are: osteoporosis (including hip fractures); osteoarthritis and joint pain; and cognitive decline (including memory loss).

The Encouraging News in 2011
According to the U.S. National Institute of Environmental Health Sciences (NIEHS), as many as two-thirds of all cancer cases are linked to environmental causes and have some (or many) risk factors or exposures that can be modified or prevented, respectively.

Environmental factors include: radiation and industrial exposure (e.g., asbestos and pesticides). Lifestyle factors include: cigarette smoking, excessive alcohol consumption, poor diet, lack of exercise, excessive sunlight exposure, and social behaviors that increase exposure to certain viruses (e.g., HPV).

Research bears out the fact that nutritional supplements can provide powerful support in any effort to address the lifestyle part of the risk factors for the diseases of aging.

B Vitamins
In April 2010, Japanese researchers published a landmark study in the journal, Stroke, which examined data from 23,119 men and 35,611 women between the ages of 40 and 79.

After 14 years of follow up, it was found that men who had higher consumption of folic acid and vitamin B-6 experienced significantly fewer deaths from heart failure. Women who consumed higher levels of B vitamins experienced fewer deaths from stroke, heart disease and total cardiovascular death.

Calcium and Vitamin D
A wide body of scientific research supports the use of supplements to prevent fractures, especially hip fractures, in older people. A 2011 review in the journal, Metabolism, confirmed this: “Combined therapy, with calcium and vitamin D, has been shown to reduce hip fracture risk,” especially in frail elderly patients.

Glucosamine and Chondroitin
A two-year follow-up on the GAIT study of glucosamine, chrondroitin sulfate, their combination and the arthritis drug, Celebrex, published in 2010, carried forward the 2008 findings that showed glucosamine provided beneficial effects in knee pain and mobility.

Memory and Cognitive Function
Anyone who has a family member who seems to be overly forgetful, or who may be struggling with signs of age-related cognitive decline, should be familiar with a recent study published in the journal, Alzheimer’s and Dementia, which provides yet additional evidence that older adults who took 900 mg supplements of purified DHA (an omega-3 marine oil) for six months experienced improved memory and overall brain health.

Gormley Take-Away? While politicians and healthcare policy experts debate how best to fix our nation’s healthcare mess, if we focus on health, including responsible self-care using diet, exercise and judicious nutritional supplementation, the mammoth healthcare structure that is built may very well wind up with a significant number of empty beds that were supposed to have patients on them. This is something to work towards, to be sure: a medical complex in search of patients!

Senate Bill 510: The $825 Million Dollar Folly

By James J. Gormley

courtesy of NOW Foods

Are you a backyard grower of heirloom tomatoes you sell on your own property or at a local farmer’s market? If so, you will be in for a whopper of a surprise if Senator Durbin’s Senate Bill 510 (S.B. 510) passes: you may be receiving a visit from inspectors.

Products not grown according to designated standards will be considered adulterated and your business records will be subject to warrantless searches by inspectors from the U.S. Food and Drug Administration (FDA), all this without any evidence that you have violated any law.

Wonder why the National Guard or Federal agents have effectively imposed martial law by quarantining your town? Under S.B. 510’s House counterpart bill, H.R. 2749 (Section 133b, “Authority to Prohibit or Restrict the Movement of Food”), sponsored by Congressman Dingell, the Secretary of Health and Human Services will have the power to prohibit all movement of all food within a geographic area, whether the food is in your grandmother’s grocery bag in her Toyota Hybrid or on a flatbed. No court order will be needed, just a phone call to the appropriate state official and a public announcement will be sufficient.

Upset that raw milk or raw milk cheeses (like feta) are no longer available in the U.S.? This could well happen thanks to the “performance standards” powers that would be granted to the FDA by S.B. 510, especially since the agency has made it clear that it is vehemently opposed to the consumption of raw milk products.

Amazed that U.S. food safety regulations strangely match those of other countries? Well, Section 306 of S.B. 510 would require “Recommendations to harmonize requirements under the Codex Alimentarius.”

And what about food supplement manufacturers, suppliers, distributors and health food stores? Will they be ensnared in this bill’s draconian, 1984-esque net? Very possibly so.

This all may seem far-fetched, but theoretically, this new law would give the government all this authority.

S.B. 510 (which would cost Americans $825 million in 2010 alone) and the House of Representatives version of this bill, H.R. 2749, which did pass under suspended rules, do not address the root causes of the U.S.'s food safety problems, which were highlighted in both a recent campaign by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and by a letter to 99 U.S. senators by the Ranchers-Cattlemen Action Legal Fund (R-CALF USA).

According to Citizens for Health (http://www.citizens.org/), if this proposed law is enacted it would:

• Undermine DSHEA and move the U.S. one step closer to harmonizing our standards under Codex with those of supplement-restrictive regimes like the European Union. (DSHEA, or the Dietary Supplement Health and Education Act, asserts that supplements are food and are safe for consumption unless proven otherwise – ensuring that millions of Americans are able to enjoy access to safe, effective and affordable dietary supplements).

• Give the FDA unprecedented control over farms and direct-to-consumer distributors. If passed, the bills would charge facilities an annual $500 registration fee, require additional record keeping, and expand FDA authority to quarantine geographic areas for alleged food safety problems – all without significantly improving food safety.

• Cost U.S. taxpayers billions of dollars ($825 million in 2010 alone) while providing fewer physical inspections and less food safety overall.

• Harm U.S. organic farmers by imposing overlapping regulations.

• Hurt food supplements and health-food stores by imposing standards that are already covered by the AER (Adverse Event Reporting) Law, cGMPs (current Good Manufacturing Practices) and food facility registration.

• Cripple local food co-ops, farm stands, independent ranchers and artisanal food producers by imposing unnecessary standards and unfair bureaucratic burdens.

Clearly, S. 510, while purporting to increase food safety would actually leave consumers more vulnerable to foodborne disease since the FDA would be required to use a risky, risk-based food safety system rather than doing old-fashioned, effective physical, on-site inspections in plants, factory farms and slaughterhouses, where the actual food safety concerns are.

Furthermore, the U.S. has abrogated its duty to inspect and enforce food safety standards, both here and abroad, by allowing processing plants to regulate themselves under a failed system; and it has embraced policies that have driven independent U.S. farmers and ranchers out of business and replaced them with corporate-owned, industrialized food production units that are known to cut food safety corners to maximize corporate profits.

So what do we need to do?

Click here for an opportunity to send a letter opposing S.B. 510 as it is currently written.

Gormley Take Away: As of this writing, our nation is over $11.8 trillion in debt. Let’s not add $825 million more (actually several trillion dollar over the next few years) for a bureaucratic monster to be foisted upon an already deeply flawed U.S. food-safety system. S.B. 510 is sadly, and ironically, not about food safety, although I wish it were. It’s about food madness, pure and simple, and it must be fixed … or stopped.

Making the “Cut”: What the Latest Recall Tells us … and Doesn’t

By James J. Gormley

So we’ve all read the headlines about the recent recall of a line of 14 dietary supplements due to 23 reports of serious adverse events linked to (but not proved to caused by) the weight-loss and bodybuilding products in question.

The product recall that was requested by the U.S. Food and Drug Administration has been applauded by the natural products industry, as it shows how effective are the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the AER Law.

If truth be told, the manufacturer should have known better, regardless of where the final toxicology reports or class action lawsuits wind up, since a number of the recalled products were made with a modern version of the dangerous old “ECA stack” formula (ephedra-caffeine-aspirin, or ECA), with each serving containing stimulant herbs, over 400 mg of caffeine plus willow bark extract (natural aspirin).

That being said, the FDA, long believed to be a foe of the dietary supplements industry, is taking advantage of the recall to repeat its oft-voiced complaint that its hands are largely tied because it must rely on voluntary reports and post-market monitoring. “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective and an isolated incident is often difficult to follow,” said the FDA’s Linda Katz, M.D., M.P.H.

Katz and the mainstream media are missing the point.

Dietary supplements, because they are a class of food products, are considered largely safe. Food products, and products derived from foods and plants, are presumed to be benign and have very little, often no known, side effects.

The ingredients in supplements are mainly natural ingredients that have co-evolved with humans from time immemorial and especially since the creation of agriculture 10,000 years ago.
They form what ethnobotanist Dr. Jim Duke refers to as the “Green Pharmacy” of healing and healthful compounds. When not used properly or used by profoundly unhealthy, often heavily medicated consumers looking for a quick fix, they are linked to a few hundred adverse event reports each year.

Drugs are largely synthetic, powerful chemical compounds that are not found in the food supply and which are presumed to be dangerous and often have very serious, known side effects.
Drug chemicals are primarily artificial compounds synthesized to dramatically change, stop, block or boost a system or process in the body in order to improve symptoms. They cause over 100,000 deaths a year and close to 1 million serious adverse events.

“Dietary supplements are not regulated as drugs because they are not drugs,” adds Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University.

According to David Seckman of the Natural Products Association (NPA), “This prompt action shows that the current DSHEA [law] works and that the adverse event reporting (AER) law that we helped to pass is working to enable the agencies to detect signals of any threat to public health. Thus, the industry is more than appropriately regulated and necessary consumer protections are in place.”

“They are regulated in exactly the same manner as all food and beverage products, including review of labeling claims, [post-market] surveillance, adverse event reporting, and so forth” agreed Blumberg. “The research base regarding most essential nutrients is more extensive than that of most drugs.”

Gormley Take-Away: DSHEA and the AER Law work very well. The FDA should cooperate with the responsible core of the natural products industry rather than criticizing the very laws that the American people saw fit to pass and which the FDA is sworn to uphold and enforce. While consumers should not be scared about this rare product recall, some manufacturers (and these few companies know who they are) should take a hard look at their products and their safety and testing data to make sure they are not repeating mistakes of the past relating to formulas and claims, because nobody benefits from inadequate vigilance, the companies included.

The FDA: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally bankrupt diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) --- along with complementary and innovative industry self-regulatory programs --- consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends (emphasis mine): “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among many recommendations, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.” Aside from the fact that the number of adverse events directly attributed to dietary supplements would be trivial, in general, especially when compared to prescription and non-prescription drugs, the SAER Law already well protects consumers.

On top of this, the FDA doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

What I would argue is that why should America give more power and more money to an agency that is ill-equipped to handle, and undeserving of, either?

Here is a brief snapshot of an agency that is in chaos, completely mismanaged and rife with corruption:

• On September 20th, 2006, Sen. Chuck Grassley (R-IA)’s “oversight of the drug-safety agency” “exposed a “too-cozy relationship with the pharmaceutical drug industry and an agency culture that has sought to suppress concerns of agency scientists about drug safety reforms.” Grassley’s demand to the FDA pointed to violations of the public trust, including: “FDA’s suppression of scientific dissent and pressure to alter or exclude [negative] information” relating to drug approvals.

• On October 17th, 2006, the U.S. federal court (Case Number 06-438M) charged a now former FDA commissioner with conflict of interest and related offenses relating to undisclosed pharma connections.

• In November 2007, the Subcommittee on Science and Technology issued a damning report on the FDA entitled FDA Science and Mission at Risk. The report concluded, in part:
a. FDA’s evaluation methods have remained largely unchanged for the last half century.
b. FDA’s scientific workforce does not have sufficient capacity or capability.
c. The FDA has demonstrated a consistent inability to implement needed changes.
d. The recommendations of reviews of the FDA are seldom followed.

• Congressman Dingell --- a leading voice now demanding more resources for FDA --- back on November 17th, 2008, charged the agency with “mismanagement of agency resources” and launched an investigation into the “integrity of the Food and Drug Administration.”

• According to the non-profit group, the Project on Government Oversight (POGO) on February 18th, 2009, “Since 2006, the FDA is not ensuring that medical devices such as defibrillators, pacemakers, replacement heart valves and coronary stents are being tested according to good laboratory practices (GLPs).”

Fortunately, a number of far-sighted consumer organizations want to improve the FDA from its foundations, such as the American Association for Health Freedom, which is leading a campaign to reform the troubled agency.

Gormley Take-Away: Despite the grandstanding consumer-safety posturing from certain lawmakers suggesting that consumers are not protected from supplements, what we all desperately need protecting from is the FDA, itself, which, in its current state, is powerful, unresponsive, political, inept and corrupt. Should we perhaps establish an agency to shield us from the FDA? Better yet, let’s completely reform the agency from the bottom up, but let’s not give more power to an agency that already has more than it deserves to wield or give more resources to FDA until it proves it has (1) eliminated corruption and (2) knows how to better manage the resources (and authority) it already has.

Vitamins C and E: The Facts Behind the Headlines

By James J. Gormley

Howard Sesso and his Harvard colleagues have just come out with their PHS II paper, “Vitamins E and C in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II Randomized Controlled Trial” (JAMA 300[18]:2123-2133, 2008)

There is even a video in which a couple of the researchers are interviewed (http://pubs.ama-assn.org/media/2008jer/1109.dtl#vnrscript ). Suffice it to say that it is likely that mainstream media shall have a field day with this paper, regardless of what it says … and what it does not say.

In reference to what PHS II does say — and these are statements that will likely go unacknowledged by most media in the next few weeks — Sesso and colleagues themselves state:

“Moreover, results in PHS II did not corroborate the significant 24% reduction in cardiovascular death or the significant 26% reduction in major cardiovascular events among women aged 65 years or older in the Women’s Health Study.

In addition, the putative increase in hemorrhagic stroke attributed to vitamin E in PHS II, was, according to Sesso and colleagues, “not observed in other primary [de Gaetanoa, 2001; Lee, 2005] and secondary [GISSI, 1999; Yusuf, 2000; Lonn, 2005; Cook, 2007] prevention trials testing individual vitamin E supplement use.”

It is doubtful that these observations will make it into most coverage, however.

What does the established body of research on vitamins C and E really show?

A wide body of scientific evidence has established that taking antioxidant supplements — including vitamins C and E, beta carotene, selenium and zinc — can help reduce the risk of chronic disease.

That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.

A number of landmark epidemiological studies have, in fact, established that vitamin E supplementation reduces cardiovascular disease progression and reduces mortality.

In the Cambridge Heart Antioxidant Study (CHAOS) (Lancet, 1996), investigators wanted to see if supplementation with 400 or 800 I.U. of vitamin E for roughly 510 days would reduce risk for myocardial infarction (MI) and cardiovascular death in 1,035 patients with ischemic heart disease (967 more received a placebo). The findings were that high-dose vitamin E supplementation significantly reduced the risk of cardiovascular death and non-fatal MI.

In a study by Boaz et al. (Lancet, 2000), hemodialysis patients with cardiovascular disease (aged 40 to 75 years) received either 800 I.U./day of vitamin E or a placebo for approximately 519 days. The results? There was a significant decrease in cardiovascular disease (endpoints) and myocardial infarction.

In another study from 2000 (Salonen et al., J Int Med), a combined supplement of both vitamin E and slow-release vitamin C reduced the progression of atherosclerosis in men by 74 percent over a three-year period of supplementation.

In the Nurses’ Health Study (Stampfer, 1993) of 87,000 female nurses over eight years, among the 13 percent of women who regularly used vitamin E supplements (of at least 100 I.U. per day), there was a 31 percent reduction in relative risk for nonfatal myocardial infarction and death from cardiovascular disease compared with women who did not take vitamin E.

In a study by Rimm (1993), in which 39,000 male health professionals were studied for four years, 17 percent of the men took vitamin E supplements. Of those who took the highest doses (median of 419 I.U. per day) had a 40 percent reduction in the relative risk for nonfatal myocardial infarction or death from coronary hearth disease.

That’s what the science really shows.

While every study, even those with null results, can contribute to the body of knowledge regarding nutritional supplementation and prevention of chronic or acute disease, it is always unfortunate when studies produce anomalous findings that contradict the already well established evidence that antioxidant vitamins are critical for health promotion, disease prevention and treatment.