Junkfood Science: Innocent children and the most vulnerable can be hurt the most

December 16, 2008

Innocent children and the most vulnerable can be hurt the most

A heartbreaking story was reported in the Australian news today about a young girl left crippled and brain damaged. Her father had come to feel so afraid and distrustful of modern medicine that he continued to give her alternative remedies for a heart infection and delayed taking her to the hospital until it was too late.

Girl brain damaged after parents refuse medical help

An alternative medicine devotee will spend six months behind bars for causing his sick daughter brain damage by refusing to take her to hospital. The Brisbane District Court was told on Tuesday the 11-year-old had been suffering from a heart infection for two weeks before her 45-year-old father finally took her to hospital.

She was gravely ill when she was admitted to Toowoomba Base Hospital in September 2006. Her temperature was 42 degrees celsius, she had been hallucinating and was weak, pale and could no longer walk. The court was told her mouth was peeling, black and clogged from the alternative medicine her father had been giving her in extremely high doses. The doctor who finally examined the 11-year-old said in a report the girl was as "sick as the sickest person I've ever seen in 35 years".

Prosecutor Belinda Merrin said it was the father's distrust of conventional medicine that had caused him to delay seeking treatment. Instead, he had been relying on the glyconutrient dietary supplement Mannatech to cure his daughter… He had been giving her so much Mannatech it had stuck to her teeth and clogged her mouth…

When the girl was admitted to hospital she underwent an emergency heart bypass and valve replacement. She spent some time in a coma after surgery because of bleeding on the brain, and it was a year before she was eventually allowed to go home. She now uses a wheelchair and has reduced vision and severe, ongoing cognitive and fine motor skills. The court was told she may never walk unaided again…

While this case is extreme, it exemplifies the dangers of nonscientific modalities — and the need for healthcare professionals and scientists to help people get sound information and to empower them with critical thinking skills to see through uncredible, marketing information and claims that can leave them needlessly frightened. This sad story from Australia also illustrates that ineffective to potentially dangerous products are widely available. Just because a product is popular and a company says its claims are based on science don’t make it so.

Alternative modalities are not harmless

Another indescribable example of this fact came last week. For five years, as readers will remember, the South African government had promoted alternative modalities, rejecting scientists and antiretroviral drugs for HIV/AIDS. A tragic report from the Harvard School of Public Health AIDS Initiative published last week in the Journal of Acquired Immune Deficiency Syndrome conservatively estimated that more than 300,000 people died as a result of not receiving ARV medicines between 2000 and 2005, and that 35,000 babies were needlessly born with HIV because their mothers had been denied prophylactic medications.

The editorial in the current issue of that Journal said this report highlights a collective responsibility of scientists and medical professionals to speak out against unsound policies and not be complacent. As the editors noted, the South African government’s advisory panel should never have been supported, but several of the country’s key scientific institutions had explicitly endorsed it and desisted from criticizing then-president Thabo Mbeki. Scientists need “to make their reasoned voices heard above the fray of political sycophancy,” it urged.

It is increasingly hard for consumers, and understandably so, with so many degreed professionals, often from some of the most prestigious institutions, promoting quackery.

Popular preventive health programs and the promotion of “wellness lifestyles” and “optimal health” are the source for much of today’s alternative modalities and serve as the best cautionary heads up for consumers.

Mannatech’s website describes the company as a “Global wellness solutions provider” and says it is “a fast-growing company focused on delivering better quality of life through scientifically validated wellness technologies.” According to its webpages, it is “at the cutting edge of wellness science” and it has an impressive scientific team. There are no clinical trials anywhere on any of its web pages, however. Mannatech is a member and on the board of the Council for Responsible Nutrition. The science endorsed by CRN, perhaps unfamiliar to many consumers, was covered here.

Mannatech offers a range of dietary supplements promising to give people the “gift of wellness.” Its supplements are said to be “inspired by aloe vera saccharide research and the exploding field of glycobiology.” According to its website, Mannatech developed “the world's first glyconutritional dietary supplement based on plant polysaccharides” — beneficial saccharides (sugar) it says that many people aren’t getting in their diet because of “pollutants, questionable farming practices [and] stress.”

To help guard against health problems, it says its products contain “plant saccharides, sources of sugars designed to support glycoprotein synthesis and immune system function:”

The aloe vera research showed that ingestion of a saccharide present in aloe vera gel could positively impact the immune system.* The glycobiology studies showed that sugars attached to proteins on cells -glycoproteins- profoundly affect human function, including immune system function and cell-cell-recognition.*

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Consumers are told: “Optimal health can be achieved when your cells function normally and communicate properly with one another… A wellness lifestyle can be reflected by achieving and maintaining beautiful skin… A healthy body weight is critical to achieving a good quality of life.”

While found nowhere on their website or product literature, the U.S. Food and Drug Administration, Texas Attorney General, U.S. District Court, and scientific community have other views of Mannatech.

The FDA issued several letters to the company in 2001, saying its claims were in violation of the Food, Drug and Cosmetic Act and subject to drug regulations. Among the claims the FDA warned were illegal and unsupported were the company’s claims for: its ImmuneStart; for its Ambrotose products that promised to “delay the onset of various degenerative conditions;” for Manna-C capsules the company claimed help manage allergic reactions; for Manna Cleanse the company said inhibits growth of unfriendly micro-ogranisms that can leave potentially toxic bacteria to cultivate in the colon; and for AmbroStart which it claimed helped lower cholesterol, control diabetes, alleviate lactose intolerance, and prevent the growth of disease-producing bacteria.

The products are sold through a multi-level marketing schemes, with half a million sales independent “associates” in ten countries. In 2005, three securities class action suits were filed against Mannatech, for purchasers of Mannatech stock from August 10, 2004 through July, 2007. Earlier this year, on March 20, 2008, Mannatech reached a settlement, agreeing to pay the plaintiff class $11.25 million.

In July, 2007, the Texas Attorney General charged the company, based in Coppell, Texas, and its owner, with operating an illegal marketing scheme in violation of state law. The state’s press release revealed its enforcement action had stemmed from a large-scale investigation by state authorities who’d examined the dubious health claims:

Documents filed in Travis County district court reveal Mannatech’s scheme to exploit families, including those challenged by cancer, Down’s syndrome, cystic fibrosis and other serious illnesses. According to investigators, exaggerated claims about the therapeutic benefits of Mannatech’s dietary supplements and nutritional products were unlawfully used to increase sales. The attorney general’s enforcement action asserts that Mannatech’s deceptive practices pose a health risk to seriously-ill consumers who may forgo traditional medical attention because of the company’s false claims.

Texans will not tolerate illegal marketing schemes that prey upon the sick and unsuspecting,” Attorney General Abbott said. “Aided by an army of multi-level sellers and their fictitious claims about its products, Mannatech has aggressively marketed supplements to countless unwitting purchasers. With today’s enforcement action, the Office of the Attorney General seeks to shut down an elaborate scheme to defraud innocent consumers across the nation.”

The Texas Attorney General charged Mannatech with being in violation of Texas Deceptive Practices Act for encouraging their salespeople to make false statements and allowing sellers to use sales tools, brochures, videotapes and personalized websites to exaggerate the supplements’ effectiveness. According to investigators, user testimonials and other marketing techniques mislead consumers into believing that the supplements dramatically cure or treat serious illnesses. “In fact, the company’s health claims are not supported by legitimate scientific studies, nor are its products approved as drugs by the U.S. Food and Drug Administration.”

An analysis of Mannatech’s claims were recently published in the August 2008 issue of the journal Glycobiology, titled “Glyconutrient Sham.” It was authored by Dr. Ronald L. Schnaar, Ph.D., and Dr. Hudson H. Freeze, Ph.D., prominent glycobiology researchers with the Department of Pharmacology and Molecular Science at Johns Hopkins School of Medicine in Baltimore, Maryland. The field of glycobiology is one pursing rigorous scientific research and has nothing to do with Mannatech, selling supplements referred to as glyconutrients, they explain. Their scientific review is available in its entirety online here.

Despite the fact that its marketing violates both federal and state food and drug laws, Mannatech has continued unabated, they warn consumers. [In fact, Mannatech had a net taxable profit last year of $10.5 million.] “People desperate for medical breakthroughs have spent billions of dollars to purchase plant polysaccharides whose medical value has not been subjected to FDA-approved clinical trials, or, in some instances, whose medical value has been disproved.”

As these scientists explain, “except for rare patients with certain types of congenital disorders of glycosylation, the inference that humans can benefit form ingesting these monosaccharides is unsupported by controlled clinical trials.” The company’s various claims of health benefits of ingesting its flagship product, Ambrotose Complex, have not been tested in controlled human clinical trials or have already been disproved in such trials and there is no scientific support for sales claims that ingesting this product is needed for “optimal health” or cures disease, they said.

More importantly, if discoveries from the field of glycobiology are misrepresented to convince seriously ill people to invest limited resources in unproven products, or to forgo standard of care, we feel that there is a moral obligation for glycobiologists to speak out.

They encouraged scientists to “raise objections when inaccurate or misleading glyconutrient marketing materials appear in scientific journals or books.” They said “it is important that we distinguish rigorous research into complementary and alternative medicine from unsupported or poorly supported marketing claims.”

The company relies on its patent application to infer the efficacy of glyconutrients and for credibility and validation, the researchers explained. Its patent includes an extensive list of scientific references of glyconutrient research and a long list of disorders and diseases which it claims can be treated, but there is no actual clinical research to support these claims, the Johns Hopkins researchers cautioned. In examining the body of glyconutrient research for any therapeutic benefits for any of Mannatech’s products or individual ingredients, they concluded: “Taken together, we find no convincing support for human therapeutic or health claims of Ambrotose Complex or its components.”

Understanding the science makes the story of that little girl in Australia even more heartbreaking. It and others like that don't have to happen if we can help people recognize and trust good science and real evidence-based medicine.

© 2008 Sandy Szwarc

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