Disputed claims boost popular supplements

Fort Worth Star-Telegram/September 10, 2006
By Danny Robbins

The photos have appeared on the Web, in magazines and on the cover of a widely circulated pamphlet.

Classic "before" and "after," they depict a girl named Michelle, first as a child with the obvious characteristics of Down syndrome, then as a seemingly typical teen.

For advocates of Mannatech Inc., the girl's physical transformation is a testament to the power of the Coppell-based company's dietary supplements, plant extracts said to provide the body with essential sugars.

"Pictures don't lie," they say, using them to sell the company's products, known as glyconutrients.

But what some perceive as a miracle is for others nothing more than the selling of false hope.

"Distasteful" and "misinformation" are just some of the words critics have used.

Michelle's story and others like it define the culture surrounding Mannatech, a publicly traded company that in recent years has enjoyed surging sales while facing mounting skepticism.

Ten years after introducing its first and best-known product, Ambrotose, Mannatech has become a major player in the direct-selling portion of the supplement industry.

The company's mix of a unique product, a message grounded in faith and a network of more than 500,000 associates has fueled sales that reached nearly $400 million last year.

But as Mannatech has grown and taken on a higher profile, it also has become increasingly characterized by associates who push the envelope by implying that glyconutrients can treat many of the diseases and disorders that defy modern medicine.

Some even state that the research of Nobel Prize-winning scientists validates the products, when in fact there's no connection.

These and other issues have caused outrage among some advocacy groups and brought scrutiny from at least two state attorneys general, a class-action lawsuit and questions from some of the world's pre-eminent scientists.

"My blood boils when I think about all the desperate people who have taken this stuff on," said Hudson Freeze, a professor of glycobiology at the Burnham Institute for Medical Research in La Jolla, Calif.

In a recent interview at the company's headquarters, a maze-like complex in the industrial park north of D/FW Airport, Mannatech Chairman and Chief Executive Sam Caster said legitimate statements relating to lifestyle improvements are often misunderstood as cures.

"We walk the fine line of always stating our case appropriately and always training our people: 'We're not into the treatment, cure or mitigation of disease. We're into the improvement of quality of life,'" he said. "Now, who can benefit from good nutrition? Sick people, well people, everybody. Everybody benefits from good nutrition."

A potential for exaggeration

Mannatech is one of the recent success stories in the burgeoning food and supplement direct sales industry.

Only Amway parent Alticor Inc. and weight-loss giant Herbalife reported higher U.S. sales in 2005, according to the Nutrition Business Journal.

"We've been looking more carefully at the companies that are pacing that growth, and Mannatech certainly is one of them," said Grant Ferrier, the journal's editor.

Direct sales companies do business through independent networks of associates who make money by selling products as well as through the sales of those they recruit.

But just as direct selling can fuel profits, it can also breed exaggerated claims.

"The risk associated with direct selling from a corporate standpoint is you're using independent contractors, who can be difficult to control," said Scott Van Winkle, who analyzes the food and nutrition industries for financial services firm Canaccord Adams. "You can take disciplinary action against those who put inappropriate things on their Web sites or make claims that aren't justified. But you can't do it until you know they did it."

The supplement industry was effectively deregulated in 1994 when Congress passed the Dietary Supplement Health and Education Act. It allows supplements to enter the market without the screening required of drugs, as long as they do not make label claims of curing, preventing or treating specific diseases or conditions.

Supplement advertising and other marketing material, regulated by the Federal Trade Commission, must be truthful and substantiated by scientific evidence. All who participate in selling must comply.

Even if a testimonial represents an individual's honest opinion, it must be backed by appropriate scientific evidence, according to FTC regulations.

"If you are making a claim, either expressed or implied, that your product is going to cure [serious conditions], I would think you would need the highest possible level of scientific validation," said Richard Cleland, assistant director of the FTC's division of advertising practices. "And testimonials aren't scientific validation."

Mannatech's guidelines for associates prohibit them from using printed or recorded testimonials citing disease-specific improvement when selling products. But those very materials are sold to associates at bulk-rate prices by a vendor the company allows to work its corporate events. In many cases, the items are produced by Mannatech associates or others affiliated with the company.

During a regional gathering for associates at the Arlington Convention Center in July, that vendor was set up near the entrance to the meeting room.

When the meeting broke for lunch, associates lined up to buy.

One of the items sold at the company's events is the pamphlet "A Gift Called Michelle," an account by the girl's mother, a Mannatech associate, of how glyconutrients eliminated the girl's asthma and attention deficit disorder and ultimately changed her appearance.

"Suddenly, it became evident that these supplements were changing more than health," the girl's mother writes. "They were changing the features of a chromosomal disorder!"

Another item, a CD called Miracle Stories, is a collection of recorded testimonials in which 15 individuals describe how they or family members used glyconutrients to deal with such diseases as liver cancer, cystic fibrosis and multiple sclerosis.

At the beginning of the CD, produced by the son of one of Mannatech's highest-earning associates, a narrator says that those who will speak are "ordinary people" sharing their experiences.

"Some have had conditions that were deemed terminal, but found something that brought about a miraculous recovery," the narrator says.

"In whatever way this recording came into your hands, it was no accident. Perhaps you need a miracle or know somebody who does. If you feel moved by these stories, please take the time to share them with others, just as someone did with you."

The vendor also sells this material online as "Glycotools." There is a link to the vendor's Web site on the home page for MannaRelief Ministries, a nonprofit organization tied to Mannatech.

Caster said he sees nothing disingenuous about the practice of allowing such items to be sold at corporate events, comparing the practice to a natural food store selling third-party literature.

"We think it's appropriate for people to have access to that," he said. "What we tell people is, 'You can't use that in the sale of product. If you want to use it to educate yourself,'" that's fine, he said.

Mannatech has been in a defensive posture since a series of class-action lawsuits were filed against it last year.

Stockholders filed the lawsuits after the price of the company's stock fell 40 percent in the days after an article in Barron's, the weekly financial publication, detailed some of its business practices.

A consolidated class-action complaint, filed in March, quotes unnamed former employees as saying the company turned a blind eye to excessive claims by top-earning associates and kept video testimonials of health claims on a password-protected portion of its Web site.

Caster and other company officials declined to comment on the suit.

Two of the former employees quoted in the complaint told the Star-Telegram that they were contacted by the Texas attorney general's office and interviewed about Mannatech after serving as sources for the class-action attorneys.

Tom Kelly, a spokesman for Attorney General Greg Abbott, said policy prohibits him from stating whether an investigation has been initiated.

Unusual route to the top

As its name implies, there is a spiritual side to Mannatech, stemming largely from Caster and his wife, Linda.

Both talk openly about how prayer was involved in the company's formation and still plays a major role in its decisions.

In a book she published about Mannatech in 2002 called Undeniable Destiny, Linda Caster compared her husband to Joseph, the Old Testament figure who stored grain to stave off famine.

"Like most of the people God has chosen throughout the ages, Sam would appear to the 'world' to be an unlikely candidate for that role," she wrote. "He never finished college, he never had experience in the world's financial community, and he was raised without the benefits of status, wealth or connections. But for as long as I've known him, Sam's had an unbelievable 'feel' for how to bring new technology to market."

Sam Caster has indeed followed an unusual route to the top of a major corporation, although not every step has been beatific.

A native of the Oak Cliff section of Dallas, Caster left Adamson High School to finish his education while performing with Up With People, the musical troupe known for touring military bases and appearing in football halftime shows in the 1960s and '70s.

He said he spent 3 1/2 years with the organization before leaving to form a bluegrass band.

In the 1980s, he started his first direct-selling venture, Eagle Shield Inc., a Grand Prairie-based company that sold home insulation and, at one point, a pest control device known as the ElectraCat.

Eagle Shield went out of business after twice being sued by the attorney general, who claimed Caster and the company used deceptive practices in selling both products.

Citing research conducted by entomologists at Texas A&M, the attorney general asserted that the ElectraCat was "no more effective in eradicating pests than a standard incandescent light bulb."

After Eagle Shield's demise, Caster hooked up with William C. Fioretti, a businessman who had studied biochemistry.

Taking advantage of the supplement act and the avenue it created to bring products to market, Caster and Fioretti started Emprise International Inc., the company that eventually became Mannatech.

At the time of the company's founding, Fioretti was seven years removed from federal prison, where he spent three years after pleading guilty to charges stemming from his involvement in two marijuana-trafficking conspiracies.

The two cases, one in Florida and the other in South Carolina, involved charges that he and others sought to obtain thousands of pounds of marijuana with intent to distribute, according to court records.

Fioretti was Mannatech's chief science officer and a member of its board of directors before leaving in November 1997, a little more than a year before it went public, according to the company's initial public offering.

Caster said he was aware of Fioretti's criminal history when they became partners and didn't consider it troubling.

"I may have a lot more grace for those type of things than some people," he said. "But I felt like he [Fioretti] was a very good guy, a very bright guy, and I thought it [having him as a partner] was appropriate."

Attempts to interview Fioretti, currently the president of a biotech company based in Baton Rouge, La., were unsuccessful.

'They literally have a sugar pill'

Mannatech initially sold Manapol, an aloe vera extract developed by a laboratory in Irving, before developing its own product, Ambrotose.

The main ingredient in Ambrotose is arabinogalactan, a substance derived from the wood of the larch pine.

The product's other ingredients are Manapol and two other plant extracts, gum tragacanth and gum ghatti.

The company believes Ambrotose and its offshoots are a source of eight sugars missing from modern diets, largely because of processed foods.

The theory, according to the company, is that these sugars are required to promote better communication between the body's cells, which in turn supports the immune system.

Mannatech executives and science personnel routinely associate the company's work with glycobiology, an emerging science that deals with the function of sugar molecules in biology and medicine.

But several of glycobiology's leading scientists have become openly hostile toward the company.

"We have no connection [to Mannatech] and really feel that in fact they are ruining the reputation of our field," said Freeze, the glycobiology professor.

In interviews and e-mails to the Star-Telegram, these scientists described themselves as alarmed by e-mails they received from seemingly desperate people asking whether Ambrotose can be used to treat cancer and other diseases.

They expressed concern that consumers are forgoing traditional therapies to use a supplement that has not been subjected to clinical trials and, in their view, has little or no therapeutic value.

"The one good thing I can say is I think they literally have a sugar pill," said Ronald Schnaar, a professor of pharmacology in the Johns Hopkins School of Medicine and a past president of the Society for Glycobiology. "In other words, it's not going to hurt anybody. You're not going to hear people say, 'I took this and got worse.'

"But people can get worse by choosing that product over another therapy that in fact might have helped."

The scientists question whether Ambrotose can be properly digested and whether it provides anything beyond what can be obtained through a normal diet.

"Absent a few dozen people who have devastating birth-defect illnesses, we make the eight sugars," Schnaar said.

In an expression of their frustration, some made it known that they would not participate in a glycobiology symposium scheduled for later this month as long as it was sponsored by Mannatech. It was canceled after the company dropped its sponsorship.

'I do believe in the products'

Caster and others affiliated with the company note that there are studies indicating that glyconutrients were helpful for patients affected by certain diseases.

Two studies in particular, one involving cystic fibrosis and the other the neuromuscular disease myasthenia gravis, are frequently cited. In both, doctors said individuals showed improvements as a result of taking glyconutrients.

Company representatives also point to the anecdotal evidence of so many who have used the products and claimed them to be beneficial.

"If you hear any testimonials, really good ones, there's a spectrum of people, from A to Z," said Robert Murray, a professor emeritus of biochemistry at the University of Toronto who serves as a consultant for Mannatech. "Initially, I found that kind of bewildering. But if you think of glyconutrients as a foodstuff, helping to build up the molecules involved in repairing tissue after disease, you can understand it."

Mannatech has a powerful ally in the medical field in Benjamin Carson, the director of pediatric neurosurgery at Johns Hopkins.

Carson, known for performing complex surgery on conjoined twins, began using the company's products after he was diagnosed with prostate cancer in 2002 and has since become an advocate, speaking at company functions.

Carson said that his urinary-tract problems disappeared after using glyconutrients, but he cautioned that his experience should not be interpreted as an absolute.

"I do believe in the products," he said. "But, as a scientist, I cannot and will not make scientific claims about them until the science has been proven."

The Michelle photos

In the Down syndrome community, Mannatech's presence has been defined by the Michelle photos.

Maria Thorpe, a teacher in Phoenix, Ore., whose son has Down syndrome, recalled a meeting she attended at a church several years ago at the invitation of a pastor who was also a Mannatech associate.

The featured speaker, she said, was a doctor introduced as having been involved in the development of Ambrotose.

As part of the presentation, she said, the doctor described testimonials and illustrated them with slides, highlighting the photos of Michelle.

"It was emphasized that the Ambrotose had actually changed her physical features and she no longer 'looked' like she has Down syndrome," Thorpe wrote in an e-mail to the Star-Telegram.

Michelle's story also was part of the printed material made available at the meeting, she said.

Thorpe, an officer in the Down Syndrome Association of Southern Oregon, said she expressed doubts about the sales pitch and was chastised by one of the women present for not wanting a "normal" appearance for her son.

"I walked into the meeting with a healthy skepticism and left feeling majorly creeped out," she wrote. "The hard sell, coupled with the misinformation and guilt, was enough to keep me away from the product and the people involved."

In response to questions about glyconutrients and vitamin therapies, the National Down Syndrome Society has issued a statement noting that such products have not been shown through clinical trials to be beneficial and that the rationale advanced for using them is unproven.

Len Leshin, a Corpus Christi pediatrician who has a son with Down syndrome and serves on the National Down Syndrome Society's clinical advisory board, said it isn't unusual for the facial features of Down syndrome children to change as they mature.

"This is speculation that's not based on anything in particular," he said of the photos. "But it's being stated as fact to sell a product.

"When you use speculation to sell a product, that's misleading. And when you're doing that to the parents of children with handicaps, it's distasteful."

Caster said he has read the pamphlet written by Michelle's mother and has no problem with its assertions.

"She is not making the claim that her daughter has been cured of Down syndrome, because it [Ambrotose] doesn't cure Down syndrome," he said. "If you read the document ... what [the mother] basically quantifies is all the quality-of-life improvements that have come as a result of the intervention of glyconutrients."

If there is a problem, Caster said, it lies with those who fail to understand the company and its products, not the company and the products themselves.

"It is a very, very difficult environment out there," he said. "I mean, honestly, we're not in the treatment, cure or mitigation business. We're in the [business of] improvement of quality of life through better nutrition.

"We think we've found an incredible complex that makes a big difference in the quality of life of people struggling for any kind of adequate existence. And it is difficult. It is difficult."

In the know

Mannatech Inc.

Founded: 1994

Location: Coppell

Products: Dietary supplements said to promote wellness

Flagship product: Ambrotose

How sold: Direct sales through network of independent associates

Where sold: United States, Canada, Australia, United Kingdom, Japan, New Zealand, South Korea, Taiwan, Denmark

Number of sales associates: More than 500,000

2005 net sales: $389 million ($259 million of that in the U.S.)

Sales growth: 32.2 percent in 2005, 54.2 percent in 2004, 35.5 percent in 2003

Publicly traded: Since 1999 (ticker: MTEX)

SOURCES: 2005 company annual report, company officials, published reports, analysts' report prepared by Avondale Partners LLC.

In the know

Debate over glyconutrients

What Mannatech Inc. says ...

"Glyconutrients are plant saccharides that provide support for the immune system. Saccharides are necessary for the body's creation of glycoforms, the structures on cell surfaces used to 'talk' to other cells."

What others say ...

MayoClinic.com: "Although animal studies suggest possible benefits from glyconutrient supplementation, there is very little research to support any of these health claims in humans. This makes it difficult to assess the potential risks and benefits of glyconutrient supplementation."

The Society for Glycobiology: "The society does not endorse use of these or other nutritional supplements and is not associated with any manufacturer or supplier of 'glyconutrients.' The society urges persons having questions regarding nutritional supplements to consult a physician before initiating use of any nutritional supplement claiming to enhance health or treat disease."

The Cystic Fibrosis Foundation Care Center Committee*: "The committee found no scientific evidence to support the claims of benefit of glyconutrient therapy in CF. The committee believes that these unsupported claims may mislead CF patients and result in the adoption of an unproven therapy and possible replacement of proven therapies. ... As patient advocates, the Care Center Committee strongly suggests that individuals with CF not adopt glyconutrient therapies without scientific evidence supporting their use."

* The committee is composed of physicians who provide care for people with cystic fibrosis and set accreditation standards for care centers.

To see more documents/articles regarding this group/organization/subject click here.