Supplement's claim to aid speech problems raises questions

CHICAGO - A suburban Chicago company is touting its mix of vitamins, minerals and omega-3 fatty acids as a "pharmaceutical grade" product that can help children with speech problems, even though the capsules are only a dietary supplement whose effectiveness has not been rigorously tested.

NourishLife, based in Lake Forest, Ill., says on its Web site that some children with verbal apraxia, a disorder that interferes with the development of normal speech, see benefits from its Speak supplement "as soon as the first week."

"Others notice advances in speech and coordination after several weeks," says the site, where a single box of 60 capsules sells for $70.

The claims are troubling to some speech-language experts who say there is no good evidence the product works, that families would be better off turning to speech therapy, which has proven benefits, and that the company is exploiting parents seeking a miracle cure for their children.

Vitamins also are not necessarily a harmless addition to the diet. Small children taking the suggested dosage of Speak would exceed the limit federal health officials have set for consumption of Vitamin E supplements because of the risk of hemorrhage.

The story is a familiar one to consumer advocates, who say buyers should beware when dietary supplements beckon from the Internet or store shelves. While the products may promise to maintain good health or improve a wide range of medical problems, the government does not regulate supplements as strictly as medications.

"It's up to the manufacturer to market a safe product," said Siobhan DeLancey, spokeswoman for the U.S. Food and Drug Administration. "There is nothing in the regulation that requires that these products be effective for their intended use."

NourishLife founder and spokesman Mark Nottoli said his product is safe and beneficial, referring to a study he says found that many children with verbal apraxia show signs of vitamin E deficiency.

"The combination of omega-3 with vitamin E together had a dramatic impact on these children's symptoms, not only helping with speech, but also improved eye contact and helping to improve pain sensation," he said by e-mail.

But the study Nottoli cited is an unscientific survey of families who answered a questionnaire posted on a Web site. One of the two authors of the paper was a pediatric emergency room doctor who developed the formulation for Speak and had previously touted the benefits of supplementation on the same site.

The company's leadership also raises concerns. A physician who has served on NourishLife's medical-scientific team, Dr. Dwight Lundell, lost his license to practice in 2008 after that state's medical board determined that Lundell, an Arizona cardiac surgeon, made mistakes resulting in the deaths of six patients.

Supplement sales represent a nearly $30 billion business. While some products are ordinary vitamins and minerals marketed to people with deficient diets, others are aimed at patients and their families with rare, chronic or difficult-to-treat medical problems.

"People get desperate, and while part of them may know better, they become vulnerable to companies that promise magical solutions," said Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, a nonprofit watchdog group.

The Dietary Supplement Health and Education Act of 1994 prohibits supplement companies from making medical claims, so labels often promise to facilitate healthy functioning or development instead.

Indeed, the NourishLife supplement's Web site says the product is used to "support normal and healthy speech development and maintenance." But in a news release, the company described the supplement as "a patented nutritional therapeutic formulation designed for the treatment of apraxia." The words therapeutic and treatment are medical claims, which the company is not allowed to make in advertising or on the product label.

The label also refers to the supplement as "pharmaceutical grade." That determination, implying the product meets the quality standards of a prescription drug, would need to be made by the FDA, Silverglade said.

Another red flag, consumer advocates say, is that the company promotes the product through testimonials. Though personal anecdotes can be persuasive, only scientific research can determine if a product is effective. Parents otherwise may credit a product for progress that occurs naturally in all children, even those with medical issues.

"Personal anecdotes based on testimonials should raise a red flag to consumers," Silverglade said. "It often indicates that little or no systemic research has been conducted on the product."

Dr. Claudia Morris, a California pediatrician who developed the Speak formulation, offers her own testimonial: She says her son partially recovered from apraxia after she gave him supplements.

Verbal apraxia, also called apraxia of speech, is a neurologically based disorder in which a person has difficulty speaking correctly and consistently. Its forms can range from mild to severe.

"Originally I was very skeptical of the potential benefits of something as simple and benign as fish oil, however the dramatic improvements were beyond description, and clearly suggested to me that there was some fatty acid metabolism dysfunction that could possibly be affecting cell membrane fluidity, leading to motor planning issues and the neurological symptoms my son was suffering from," she wrote to the Tribune in an email.

Morris's paper, published in the journal Alternative Therapies in Health and Medicine last summer, found 181 of 187 children with verbal apraxia showed "dramatic improvement" in their speech after taking the Speak formulation or another combination of omega-3 and vitamin E.

Many of the subjects were recruited from a Web-based support group and resource center for families dealing with apraxia, called the CHERAB Foundation. Morris had posted frequently on the site about the value of supplements before conducting the study, and the investigators relied on parents' subjective observations of their child's responses to the supplement. There was no control group, which scientists use to check whether perceived changes are caused by a treatment or by the placebo effect.

In her email, Morris said her study was a series of case reports, not a clinical trial.

While some parents report benefits from the supplements, others have described adverse effects. Lisa Geng, who lives in Florida, said her son Tanner had mild seizures and regressed after he took Speak at age 11.

Geng, a moderator of the CHERAB site, said apraxia made it hard for Tanner to express himself in words, which was frustrating for him and heartbreaking for her. "He couldn't smile or pucker to kiss," she said. "He couldn't form his mouth to make sounds."

Tanner, now 14, has improved dramatically after undergoing intensive speech therapy as well as following a diet that includes whole-food nutrition as well as supplementation with essential fatty acids and essential amino acids, according to Geng.

Lori Malott of Cincinnati said her daughter Hannah, then 3, had seizures for the first time after taking Speak. "I think the FDA should pull it off the market," she said.

Malott and Geng both said they suspect the formulation might contain too much vitamin E.

A Speak capsule contains 250 IUs of Vitamin E, and the package insert says "toddlers and small children may see the best results with 2-4 caps daily." That amount would exceed the limits on vitamin E supplementation set by the National Institutes of Health for children age 1 to 3, which is 300 IUs a day. The tolerable limit for children 4 to 8 is 450 IUs.

Nottoli said by email that the limits for children were "arbitrarily chosen" and there is research to support the safety of vitamin E supplementation. "Since we introduced the Speak supplement nearly two years ago, several thousand families have used the product with not a single report of bleeding," he said. The product insert suggests parents discuss use of dietary supplements with a health care practitioner.

Margaret Rogers, chief staff officer for science and research for the American Speech-Language-Hearing Association, said her group was not aware of any evidence that suggests the product makes a difference.

"It's not totally out of the question that there could be some dietary supplement that could help," Rogers said, "but it seems quite premature to make such claims based on anecdotal evidence."

Sharon Gretz, executive director of the Childhood Apraxia of Speech Association of North America, said she worries about families spending money on questionable treatments. The costs of using Speak vary, depending on size of purchase and dosage, but they can compare to the cost of some prescription medications, even with insurance.

"It disturbs me when parents are struggling to pay for speech therapy, which we know can be effective and sometimes isn't covered by insurance, and also using their limited resources for these kinds of things that aren't supported by science," she said.

Last month, the NourishLife Web site featured a biography and photo of Arizona surgeon Lundell as part of its leadership team. Displayed nearby was a link to the company's SpeechNutrients division, which sells Speak.

When the Tribune asked Nottoli about Lundell, Nottoli referred to the surgeon as a paid adviser and said he didn't think Lundell's license revocation was relevant. Several days later, Nottoli said Lundell was "no longer actively involved with the business," and Lundell's information was removed from the Web site.

Contacted by phone the next day, Lundell continued to identify himself as a member of NourishLife's scientific and medical team, which he said was an unpaid position.

Both said Lundell was not involved with the formulation of Speak. Lundell later said by email: "I have had no involvement in the development or marketing of the Speak product, I do not consult or advise Nourishlife."

NourishLife also sells a supplement called Learn, saying it gives children "the support to succeed in school and in life" and is "formulated to provide maximum improvements in their attention, behavior, and concentration."