Medicine Archives - Suzanne Sataline

Health Claims Boost Supplement Firm

Posted on May 11, 2007 by Suzanne Sataline

True Believers

Health Claims by Sales Force Boost Supplement Firm

By Suzanne Sataline
May 11, 2007

When doctors found a tumor in Angie McHenry’s bowel in the spring of 2006, they told her that her cervical cancer had become terminal. But her uncle, Stephan Huffman, gave her some hope.

Mr. Huffman, a retired high-school teacher, is a sales associate for Mannatech Inc., a publicly traded company that markets vitamins and nutritional supplements. He and his wife persuaded Ms. McHenry to swallow, each day, 32 Mannatech tablets and six scoopfuls of the company’s Ambrotose, a derivative of aloe vera and larch-tree bark.

“He said it would knock the cancer away,” recalled Ms. McHenry, a Coldwater, Ohio, mother of three, in an interview last month. “I would go into full remission. He said he had seen proof in other people.”

Mannatech, based in Coppell, Texas, relies on an army of enthusiastic consumers of its nutritional supplements to sell the products to family, friends and others. These sellers are unsalaried, but receive commissions and bonuses from the company, based in part on their recruitment of other sellers. Some of them make sweeping claims about the power of Mannatech products to provide relief from serious diseases.

In the eight years since Mannatech went public, several questions have loomed large for company executives and board members: Are nonemployee salespeople pushing its products in ways that violate Food and Drug Administration guidelines? And how far should Mannatech go in policing its free-lance sales force?

About half of Mannatech’s supplements, the company says, contain nutritional sugars it calls “glyconutrients.” The body needs simple sugars, but some scientists say there is no proof that sugar supplements provide health benefits. Mannatech say its glyconutrient mixture, called Ambrotose, “supports the immune system.” Because none of the products are approved by the FDA for the treatment of disease, it isn’t legal for anyone to market them as such.

Mr. Huffman, who sold $1,200 of Mannatech products to Ms. McHenry, says he doesn’t recall telling her they would “knock her cancer away.” He adds, though, that “in many instances,” Ambrotose “encapsulates the cancer.”

Ms. McHenry consumed the tablets and powder for two weeks last year, she said, until nausea made them difficult to swallow and her oncologist persuaded her to quit. Mr. Huffman says he returned her $1,200 to alleviate hard feelings. Ms. McHenry died on April 20.

“Nobody is claiming these products by themselves are providing a treatment for disease,” says Mannatech Chairman and Chief Executive Sam Caster, one of the company’s founders.

Mr. Caster identifies himself as a Christian, and some customers are drawn to the company for that reason. He and his wife, Linda, refer to Mannatech as a blessing, and say God spoke through her to give him the idea for the company. Many top salespeople share their religious beliefs. Marshall Howard, a salesman who says he’s a Christian, recently told hundreds of associates at a gathering that they were “chosen” people in the “glorious mission of Mannatech to change hundreds of thousands of lives.”

Such fervor is visible when Mannatech devotees, many of them nonsalaried sales associates, gather for an annual company-sponsored event called MannaFest. At this year’s gathering, a four-day affair held in Dallas in March, at least 10 people came on stage one night to testify that after taking Mannatech products, they recovered or found relief from conditions ranging from paralysis to tumors to lesions. Another 25 people said they took glyconutrients and found relief from afflictions such as leukemia, arthritis, cystic fibrosis, Down syndrome and cancer.

Mr. Caster says the consumer testimonials are perfectly legal because none use the words “cure,” “treat” or “mitigate” in referring to diseases. Mannatech product labels, which are reviewed by the FDA, state that the products are “not intended to diagnose, treat, cure or prevent any disease.”

Mr. Caster says that message is repeated frequently during conference calls with associates. He says he and the company abide by all laws, and train associates to do the same.

Nevertheless, scrutiny of the company’s marketing has been increasing. The Federal Trade Commission has logged at least 30 complaints about Mannatech since 1998 alleging deception, making false health claims, and improper sales practices. The FTC has brought no action.

After reports about the company’s sales tactics caused its stock to drop in 2005, shareholders filed lawsuits in state and federal courts. Several have been consolidated as a federal class-action in Dallas federal court. It alleges that executives knew about and ignored improper health claims by employees and salespeople, and that Mr. Caster overruled recommendations by the company’s regulatory-compliance committee to discipline big sellers who made such claims.

Mr. Caster says the company has fined some associates as much as $25,000, and has terminated some for making improper claims. “Does something like this ever get away from us?” he says. “Well, of course. Those are the types of things that we’re out there looking for, and that we’ll catch.” He says the company intends to vigorously defend itself in the litigation.

The Texas attorney general’s office indicated in a memo last October that it had been investigating Mannatech for possible health-law violations since 2005. The memo, reviewed by The Wall Street Journal, said the state “anticipated filing suit against” Mannatech for alleged violations, including “unproven health claims.” To date, the attorney general has taken no action. A spokesman for the attorney general declined to comment.

Mannatech’s vitamins, powders and capsules aren’t sold in any stores. The company sells them over the Internet, and through a large sales force of free-lancers. It has no salaried sales force. Companies whose salespeople are independent, and are paid based on their own sales and those of other sellers they directly and indirectly recruit, are known as “multilevel marketers.”

Mannatech has more than 100,000 active sales associates, arrayed in a hierarchy. Mannatech pays commissions to associates based on the purchases of the associates they recruit and others down the line from them. To be eligible for financial bonuses, an associate must buy $100 in Mannatech products each month. Top Mannatech associates have earned as much as $1.6 million a year, according to compensation information shared with associates at MannaFest.

Books, home and beauty products, and cleaning materials have long been peddled in this fashion. These days, so are many nutritional supplements. Multilevel marketers accounted for $4.4 billion of $22 billion in sales of dietary supplements in 2006, says Grant Ferrier, editor of Nutrition Business Journal.

Mr. Caster helped start Mannatech in 1993. Months later, Congress passed the Dietary Supplement Health and Education Act. Under that law, makers of dietary supplements aren’t currently required to document that their products are safe or effective. But it bars them from claiming, without FDA approval, that any product can treat, cure or prevent illness.

Mannatech went public in 1999, and sales have grown steadily. Last year, Mannatech earned $32.4 million on sales of $410 million, compared with $1.9 million earned in 2002, on sales of $141 million.

Early on, Mr. Caster and his wife turned to friends and prayer partners to sell products and recruit other salespeople, according to Ms. Caster’s self-published book, “Undeniable Destiny.” Steven Barker, a professor of veterinary medicine at Louisiana State University who served as a Mannatech director from 1998 to 2002, said the board was concerned about religious influence on marketing.

“People would become overzealous and start making claims that this was manna and it had miraculous properties, that it was God’s gift,” says Mr. Barker. “Sam is a very religious individual, and he would listen to people making claims they thought were miraculous….The board wanted him to tone it down. They didn’t want it to become a revival, some kind of ultrareligious event.”

Roger E. Beutner, a retired engineer who served on the board until 2003, says “exaggerated” claims about product benefits made some directors uncomfortable.

Co-founder Charles “Skip” Fioretti, then chairman and chief executive of Mannatech, worried that the FDA could take action on unproven claims, says Mr. Barker. In addition, there was tension between Messrs. Caster and Fioretti over business issues. In 2000, the board removed Mr. Caster as president after what he says was a clash of values with Mr. Fioretti. Mr.

Caster became co-chairman, but quit weeks later. Mr. Fioretti did not return calls seeking comment.

Mr. Caster’s supporters were upset, according to Mr. Barker, and Mr. Caster returned as a director within weeks. Mr. Caster says he made it clear that he and his wife intended to talk about their faith when speaking about the company. Eventually, more of his supporters joined the board, and by 2002, Mr. Fioretti had left. Mr. Caster became chairman, and later, chief executive.

These days, God and the Bible are mentioned frequently by some sales associates during meetings and conference calls. At this year’s MannaFest, one associate led a training workshop called “Leadership Lessons from Moses,” which used quotes from Exodus. At “Leadership Skills from a Biblical Perspective,” associate Dottie Anderson described “Jesus as the first network marketer.”

To sell the products, many associates rely on testimonials and case histories. At Mannatech conferences, H. Reginald McDaniel, a Dallas-area pathologist and the company’s former medical director, sells various reports containing case histories. He says he has chronicled hundreds of cases of patients with cancer, Parkinson’s disease, allergies, and cystic fibrosis whose health improved, and some whose symptoms disappeared, after taking glyconutrients. “I’d be derelict if I implied everyone with an improved diet gets a turnaround in health, yet a significant number do,” he says.

During the “testimonials” program at this year’s MannaFest, a mother showed slides of her two sons in hospital beds. After taking glyconutrients, she said, they are now free of brain seizures. A young man walked to the microphone and told the crowd that he had been paralyzed from a car crash before taking Ambrotose.

Jordan Scott, a wan 13-year-old from Lubbock, Texas, said that when she was a toddler, cystic fibrosis frequently left her choking on mucus and battling lung infections. She began taking glyconutrients, she said, and she can now play the oboe, and she placed third at a cross-country meet. “A doctor said I have the lungs of a healthy child,” she said, sobbing and thanking God, as the audience applauded.

Mr. Caster says Mannatech products are “not a cure for cystic fibrosis….I think dietary supplements can improve the quality of life.”

“I have never, ever said” that testimonials “should substitute for science,” Mr. Caster says. Health benefits reported by users, he says, help “guide us in our research.” Mannatech says it is conducting studies on the benefits of using its products.

Some researchers says they doubt that Ambrotose offers any health benefits. Hudson Freeze, who studies complex carbohydrates as a professor of glycobiology at the Burnham Institute for Medical Research in La Jolla, Calif., contends the body can’t digest Ambrotose because humans lack the enzymes necessary to break down the plant fibers it contains into simple sugars.

Mannatech has said it has completed a study that shows the body can break down glyconutrients, and that it is slated for publication in the Journal of Alternative and Complementary Medicine. The journal’s managing editor, Barbara Nell Perrin, says it will publish an abstract of the study that will not be peer-reviewed.

Mannatech associates often post messages on Web sites, including the MannaShare forum on Yahoo.com, seeking tips on selling Mannatech products to people with specific afflictions, including cocaine addiction, hemophilia and Down syndrome.

“If anyone anywhere has any information — studies, testimonies, anything — on glyconutrients and esophageal cancer — PLEASE e-mail it to me,” Mannatech associate Joan Francis, of Batavia, N.Y., wrote in January on one forum, after her father had been diagnosed with the disease.

After posting the message, Ms. Francis says, she consulted with several doctors who recommended amounts of Mannatech glyconutrients to take. Dr. McDaniel, the company’s former medical director, was one of them, she says. Ultimately, she persuaded her father to forgo chemotherapy and take Mannatech supplements.

Her father, George Schaefer Jr., says he was skeptical, but agreed to try. He bought about $700 worth of supplements over two months. Recently, on the advice of his son, he stopped taking the products and switched to chemotherapy, Ms. Francis says.

Betty Wiggins, a Durand, Mich., grandmother who identifies herself as a nurse, says she has advised more than 3,000 people over the past five years to take Ambrotose for everything from vomiting to cancer. For lung

cancer, for example, she says she recommends 100 grams of Ambrotose per day. “I don’t have anyone who hasn’t fully recovered from any illness,” she says. “You aren’t supposed to say someone is healed, for some reason.”

The Texas Department of Health Services periodically reviews Mannatech’s product labels and promotional materials, among other things. Cynthia Culmo, a former director who oversaw Mannatech inspections, says that recommending Ambrotose to treat a disease, or specifying dosage amounts beyond the guidance given on the label, are “likely” violations of federal law.

Mr. Caster says he did not know about Web sites that suggest dosage amounts.

For the desperately ill, the Web sites can be seductive. Jackie Wells, a nurse in New Mexico, was diagnosed last year with amyotrophic lateral sclerosis, the degenerative nerve disease that killed Lou Gehrig. A Web site suggested treatment with glyconutrients, and she consumed $130 of Ambrotose over six months. She has lost use of her arms and now relies on her husband to feed her and brush her hair. “I felt like somebody had taken advantage of me,” she says.

After Jeffrey Cook of Sleepy Eye, Minn., was diagnosed with renal cell carcinoma, two local Mannatech associates gave him a DVD containing testimonials, recalls his wife, Jane. “The video showed a guy with the same type of cancer,” says Ms. Cook, a licensed nurse. “It had healed him, basically.”

The associates, Melissa and Pat Schroepfer, sold Mr. Cook $1,000 worth of glyconutrient products, says Ms. Cook. Mr. Cook died last October, a month later. The Schroepfers reimbursed her the money. Melissa Schroepfer declined to comment, and Pat Schroepfer, her father, didn’t return calls.

The Wall Street Journal

To Treat Cancer,  Herbs and Prayer

Posted on January 24, 2007 by Suzanne Sataline

To Treat Cancer, Herbs and Prayer

By SUZANNE SATALINE
January 24, 2007

As her lung cancer spread, shortening her breath, pressing into her back, Minna Shakespeare had faith that a thick, brown liquid she bought by mail from a California physician for $13,536 would cure her.

Her husband says Mrs. Shakespeare, a registered nurse and devout Christian in Cambridge, Mass., stopped chemotherapy on the doctor’s advice. Easton Shakespeare recalls his wife assuring him that the doctor, who prayed with her over the phone, was trustworthy.

Mrs. Shakespeare died in April 2003, four months after her first dose of the viscous liquid. Her husband’s complaints triggered a federal investigation of Christine Daniel, a licensed physician and Pentecostal minister practicing in Mission Hills, Calif. Investigators say she used religion to sell expensive nostrums that she claimed could cure cancer.

Dr. Daniel’s small business is part of a boom in “Christian wellness” — dietary supplements and herbal formulas, sometimes along with diets inspired by Biblical descriptions, that sell briskly in a lightly regulated industry.

Sales by religiously affiliated companies have surged since the mid-1990s to account for 5% to 10% of the dietary-supplements business, which had about $21 billion in 2005 sales, says Grant Ferrier, editor of Nutrition Business Journal in San Diego.

The products are heavily promoted on religious TV, radio and Web sites through ads featuring testimonials akin to those that evangelicals share in church services. “Rather than sending money to the guy on TV who promised to heal you, you now can send your money for a book on diet and a list of supplements,” says Donal O’Mathuna, a chemist and co-author of a book on alternative medicine.

Federal authorities have identified at least three dozen people who drank Dr. Daniel’s mixtures, says a person familiar with the matter. Among those, at least eight people died of cancer, according to a Food and Drug Administration investigator’s affidavit. Some patients bypassed conventional therapies for Dr. Daniel’s regimen, according to the affidavit, patients and family members.

In a brief phone interview, Dr. Daniel said she has sold no substances, and only provides palliative “end of life” care. “The federal government has it wrong,” she said, describing federal investigators as “nut cases” and “evil.” She declined requests for further comment.

Her Tarzana, Calif., attorney, Manuel Miller, added, “Obviously it goes without saying, we deny anything improper or illegal that’s been done by her. She’s totally innocent.’’ He said Dr. Daniel “would never under any condition” tell a patient to stop chemotherapy. He said he wasn’t familiar with products patients say they bought from his client. “When you’ve got the last stages of cancer, you’re looking for anything possible. The issue is: Did she ever say this will cure cancer?”

According to the FDA investigator’s affidavit, on a 2002 religious broadcast Dr. Daniel touted cancer cure rates of 60% or better. In an interview with the California Medical Board, she denied making that claim, the affidavit said. It said she acknowledged selling vitamin mixtures but said they had no regulated ingredients. A prosecutor said there’s no evidence she’s still selling the products.

Former patients and the affidavit say Dr. Daniel sold at least six different liquid formulas. FDA analysis found some of the formulas contained various herbal compounds, as well as protein powder, vitamins, alcohol, and beef extract. Some patients said they paid as much as $6,000 weekly for care at Dr. Daniel’s wellness clinic, while others report paying a similar amount for a monthly supply of her mixtures. For some patients, office visits were covered by their medical insurance.

The FDA is looking into allegations that Dr. Daniel violated federal law by introducing an unapproved drug into the market, misbranding a drug, and committing mail and wire fraud, the affidavit says. Prosecutors filed the affidavit under seal in U.S. District Court Los Angeles in January 2006 to obtain a search warrant of Dr. Daniel’s home and office. “There is nothing wrong with a medical doctor claiming that they can cure someone,” said lead prosecutor Joseph O. Johns, an assistant U.S. attorney. “What is illegal is selling an unapproved new drug and claiming that it can cure cancer.’’ A federal grand jury has heard testimony in the case, say lawyers for a witness and for Dr. Daniel, who both testified last year.

Mr. Shakespeare thinks the doctor hastened his wife’s death. “She was charging us for one thing, but selling us another,” he says. “I think the operation she had was all a scam. And it was a well-organized scam.” Mr. Miller, Dr. Daniel’s lawyer, said she had done nothing improper in the case.

The supplement business has boomed since passage of the 1994

Dietary Supplement Health and Education Act. Under the law, manufacturers of dietary supplements are not required to document that their products are safe or effective. The law bars makers from claiming they can treat, cure or prevent illnesses without specific FDA approval, but lets them tout benefits such as “improved digestion.”

The FDA sent 75 letters last year warning supplement makers of possible violations, while the Federal Trade Commission has brought 126 prosecutions in the past five years against such companies for fraud and deceptive advertising. Critics and government officials say regulators are swamped by the rise in dietary supplements and unable to monitor them all.

Jordan Rubin, author of “The Maker’s Diet,” which its publisher says has sold 1.8 million copies, has run afoul of both the FDA and FTC. Mr. Rubin is the founder of Garden of Life Inc., West Palm Beach, Fla., which sells supplements. Mr. Rubin has told church and television audiences that “God healed me” from Crohn’s disease, he said in an interview. In 2004, the FDA warned the company to stop claiming the products could treat illnesses including colon cancer and arthritis.

In March 2006, Mr. Rubin and his company settled FTC charges by paying a $225,000 fine and agreeing to change advertising for four products including “Primal Defense,” which the commission said was marketed as a treatment for asthma, lupus, and Crohn’s disease. In an interview, Mr. Rubin said his company had $45 million in sales last year, is in full compliance with the law and plans to start an organic food line.

Others have lived within the regulatory limits. Physician Don Colbert, author of “What Would Jesus Eat?” sells supplements through his company, Divine Health Nutritional Products, with plant compounds that the company says are “important in preventing both heart disease and cancer” and strengthening the immune system.

Reginald B. Cherry, an Arkansas cardiologist and author of “The Bible Cure,” appears weekly on religious cable channels and says tens of thousands of people buy his herbal products. One with notoginseng and hawthorn berry “may help maintain a normal heart rhythm,” according to his company’s Web site. Both doctors say their marketing complies with federal standards, and no regulators have objected.

California’s Dr. Daniel works out of a one-story stucco building with security grates that she shares with a termite-extermination business in Mission Hills, Calif., a dusty working-class and immigrant neighborhood. A petite woman with a quick walk and an arresting smile, Dr. Daniel graduated from Temple University Medical School in 1979 and started practicing medicine in the Los Angeles suburbs the next year. Her practice was housed in several strip malls before her current location in the San Fernando Valley. Along the way she opened the wellness clinic, marketed under several names, alongside her conventional practice, called Sonrise Medical Clinic Inc. They shared a phone number.

Dr. Daniel says she has witnessed medical miracles. In a self-published 2006 book, she recounts how, after she prayed, a stroke victim walked without a cane and a drowned child with no vital signs returned to life. “I do not use prayer as a medicinal tool, but a combination of prayer with my medical care has never hurt any patient; if anything, it has saved lives,” Dr. Daniel wrote.

She closes her office daily at lunchtime for prayer, she wrote. Traci Wooden, a former receptionist who left in 2004, says staff members would arrange chairs in a circle and invite patients to join in. Dr. Daniel would sometimes pray in tongues — unintelligible speech considered divinely inspired — as she sought Jesus’s help, according to Ms. Wooden. One staff member had the title “prayer counselor,” according to Dr. Daniel’s 2006 book.

Over the years, Dr. Daniel acquired a reputation in Los Angeles for helping the downtrodden. “She’s got a generous heart,” says Martha Graham, a civilian employee with the Los Angeles Police Department. The doctor has treated many homeless people and welfare recipients, and volunteered at weekend health fairs, say Ms. Graham and Ms. Wooden. After fires in San Bernardino County in October 2003 drove many residents from their homes, Dr. Daniel donated blankets, diapers and her own clothes, Ms. Graham says.

Ms. Wooden says she started work the month after Dr. Daniel publicized her wellness practice on Dec. 5, 2002, on the “Praise the Lord” program on Trinity Broadcasting Network. TBN is television’s largest Christian broadcaster, with 10 million viewers weekly, a network spokesman says. She appeared again in May 2003. After the first show, Ms. Wooden says Dr. Daniel saw as many as 40 patients a week, which gradually dropped to about half that number. About half the patients at any given time were given supplements, she said.

According to the FDA affidavit, Dr. Daniel said on the show that her cancer treatment combined prayer with herbs from around the world. She had not found radiation to be effective, she said, but patients with advanced cancer were “living today because of our treatment,” and even her “lowest level” formula had a 60% cure rate. Dr. Daniel told viewers that a Michigan woman whose breast cancer had spread to her brain had normal blood tests within two weeks of taking her first dose, the affidavit said. The network aired the clinic’s phone number.

Eugenia Vigiletti from Norwalk, Calif., a retiree with breast cancer, was a viewer who visited the clinic. “I figured Dr. Daniel was honest, otherwise TBN wouldn’t have her on her program,” she says. She paid $1,400 for an office visit, a one-time mixture and heat lamp to shrink her tumor, she says. She didn’t return, after a disagreement over insurance coverage.

TBN requires on-air guests to sign waivers absolving the network from liability, says Colby May, outside counsel for TBN, a religious nonprofit. Nobody at TBN “will knowingly put on anybody who is making claims of matters of medical context that are known to not be true,” he says. Dr. Daniel appeared on the show again in May 2003, a network spokesman said.

Dr. Daniel also gained patients through her Pentecostal church, New Christ Memorial in San Fernando, where members often testify to medical miracles they say they have experienced. Church member Olivia McClurkin put her faith in Dr. Daniel. A professional gospel singer, she learned she had cancer in both breasts in 1999. While another doctor recommended a mastectomy and chemotherapy, Dr. Daniel told Ms. McClurkin that her treatment would get rid of the tumors, the patient recalls.

Dr. Daniel denies saying that, said her attorney Mr. Miller. “She’s not saying that any of her herbs cure cancer,” he says.

Ms. McClurkin moved closer to the clinic and visited it daily for 90 days in the spring of 2001. After a staff member prayed with her each day, she says, she drank a concoction with “exotic herbs and roots from Africa” that, she was told, Dr. Daniel collected on twice-yearly trips. Ms. McClurkin said it was thick and muddy and tasted like “hot garbage on a summer day.” Then she swallowed about 20 pills that Dr. Daniel’s staff gave her, she said.

She said the doctor and staff would not disclose the composition of the pills or the liquid, despite her repeated inquiries.

The tumor initially shrank and Dr. Daniel said she was improving, Ms. McClurkin recounts, but then it began growing through the skin and ulcerating. She says Dr. Daniel then treated it with ointment, with no improvement. After 90 days, Ms. McClurkin told Dr. Daniel she was leaving. “She told me if I left her, I would die,” the patient says.

Ms. McClurkin returned to her family’s home in Long Island, N.Y., but didn’t treat the tumor right away. Beginning in 2003, she has had a total mastectomy on her right side, a lumpectomy on her left breast, 19 lymph nodes removed and a hysterectomy, says her doctor, breast cancer surgeon David I. Kaufman. The cancer moved to her lungs, liver, chest wall and several bones. She is bald. Given how long she put off medical treatment, “It’s amazing she survived,” Dr. Kaufman says, adding that her condition is stable.

Ms. McClurkin ascribes her survival to Jesus — not Dr. Daniel. “I would question if she is or is not a Christian,” Ms. McClurkin says. “That’s between her and God.”

Jean McKinney, a colon-cancer patient, sought Dr. Daniel’s treatment as a last resort after having part of her colon removed and being told by oncologists that she had no medical options left. Starting in December 2003, her husband said, she swallowed a herbal remedy at Dr. Daniel’s clinic and sat under a heat lamp to shrink the tumor. The visits cost $6,000 a week, for which Dr. Daniel would not take insurance, says the patient’s husband, The Rev. George McKinney, a Pentecostal minister in San Diego.

Mr. McKinney says Dr. Daniel didn’t promise to cure his wife, but did indicate that “there were persons who came to her with serious cancer and it would be healed.” After three months, he said, Dr. Daniel advised his wife to go into chemotherapy. By May 2004, the cancer had spread to Mrs. McKinney’s uterus and lungs, and she died a month later. Mr. McKinney estimates that Dr. Daniel’s treatment cost $144,000, sending him into debt for a time. Still, he credits the doctor with giving his wife hope for survival that he believes extended her life.

Dr. Daniel handled other clients by phone, including Minna Shakespeare, according to interviews and the affidavit. After reading Mrs. Shakespeare’s X-rays in December 2002, Dr. Daniel recommended her fifth strongest formula, which cost more than $6,000 for a one-month supply, says Mr. Shakespeare, an electrician. His wife told him that Dr. Daniel said

“she knew of a lot of people where traditional medicine didn’t work, but when they take her medication, they recover,” he says.

A month later, blood tests ordered by Mrs. Shakespeare’s Massachusetts doctor showed her cancer cells were still multiplying. Dr. Daniel then sold her the highest-concentration formula, the husband said. Dr. Daniel wouldn’t tell the couple what the formula consisted of, he said. An FDA lab found that one mixture that Mrs. Shakespeare took contained carbohydrates, ascorbic acid, fructose, protein, alcohol, vitamins and caffeine, according to the agency’s affidavit.

Dr. Daniel then advised Mrs. Shakespeare to resume the chemotherapy she had stopped, her husband says. In February, Mrs. Shakespeare stopped taking Dr. Daniel’s liquids and underwent chemotherapy.

After his wife’s death, Mr. Shakespeare called Dr. Daniel and demanded a refund. When she refused, Mr. Shakespeare phoned consumer groups, one of which contacted the California Medical Board, triggering a joint investigation with the FDA.

In December 2003, Dr. Daniel told an undercover California Medical Board investigator, posing as a cancer victim’s son, that she offered herb mixtures priced from $350 to $4,270 for a formula called C-6 6:4, with the higher concentrations “working better,” the affidavit states. “The FDA does not allow us to say we cure anybody, but this is what we do,” it quotes her as saying.

At a meeting with medical board staff in August 2004, Dr. Daniel said she rarely treated cancer, the affidavit states. She said she shipped most cartons of nutritional supplements overseas as part of a food program in developing countries.

She remains licensed in California, says a medical board spokeswoman. The case is still under investigation.

Popular Science

War Wounded Hope for Breakthroughs

Posted on July 19, 2006 by Suzanne Sataline

Waiting For an Arm and a Leg

By Suzanne Sataline
July 2006

There’s always a Plan C—West Point teaches you that. If the road is mined, the bridge in splinters, and your opponent’s brigade massing on your left, you find a new road, build a new bridge. That´s Army DNA, the building blocks of a successful warrior, and it has been flush through Capt. Dawn Halfaker’s cells since her first weeks at the elite military college and as a guard on its women’s basketball team. Keep moving. There´s always another way.

Then you graduate and, because you’re an action junkie thrilled by weapons and foreign cultures, you´re assigned to run a military police station outside Baghdad. One morning before sunrise in June 2004, you´re bumping along in a Humvee on a routine patrol when someone aims a rocket-propelled grenade your way. It’s a lucky shot. The bomb tunnels into the carriage, shears off your buddy´s arm, and blasts through your own, making spaghetti out of tendons and muscle. What the insurgents don´t get, the surgeons finish off, leaving you with nothing below your shattered right scapula but expectations.

You’re 24, a child of the computer age. When you wake up and learn there is no more right arm to write and eat and shoot jumpers with, you just know that the country that invented supercomputing and reconstructive surgery can give you something gleaming and spectacular. An arm to rival Will Smith´s appendage in I, Robot.

Since the invasions of Iraq and Afghanistan, more than 370 U.S. soldiers have had amputations. Indeed, there are wheelchair traffic jams on the third floor of Walter Reed Army Medical Center in Washington, D.C. That´s where Halfaker befriended Melissa Stockwell, a former gymnast and rock climber who was in Baghdad for only a few weeks before she lost her left leg to a roadside bomb in April 2004.

The two women bonded in frustration. Stockwell, 26, received the microprocessor-enhanced C-Leg but struggled for months to walk free of pain, wishing that the large silicone socket holding what she calls her “little leg” wouldn’t chafe or thrust to the side, broadcasting her limp. Halfaker was the lone female soldier with what’s bloodlessly called a shoulder disarticulation, her right side barren like a sheer cliff. Prosthetists fit her at first with a partly mechanical, partly battery-powered arm held on with a thick plastic socket that fit like a shield and was Velcroed around her body. The device worked with muscle power; when she shrugged, pulleys and cables would trigger the motorized arm to open a blocky claw. It was a prosthetic born out of a previous war, uncomfortable and clumsy, and made her feel like a Playskool toy-and she let the prosthetists know her displeasure. “I don’t want an arm that weighs 20 pounds. I want an arm that weighs three pounds,” she told them. Something that wouldn’t slow her down. She was offered a hand that was a hook, a device straight out of the post-World War II weepie The Best Years of Our Lives. Absolutely not. “Because,” Halfaker said, “it looks like a hook.”

And that was it. There was no Plan C. For Stockwell, there was no leg and socket that would allow her to stride quickly and pain-free, that didn’t leave raw, angry marks on her pale thigh. For Halfaker, there was no arm that was strong and nimble and light enough that she could slip it under a silk blouse. Stockwell persisted, learning to walk in her new mechanical leg, though with a noticeable limp. She adapted. Halfaker rebelled, left her arm in a heap in her room. She learned to wash, dress, drive, and run with one arm, her empty sleeve dangling by her side. She adapted too.

But one day soon, in part because of the experiences of Iraq veterans like Stockwell and Halfaker, prosthetics wearers won´t have to do so much adapting. It´s the prosthetics that will be doing the adapting.

Prosthetics Manhattan Project

Nothing about a prosthetics patient’s fake limbs is optimal-not their speed, mobility, comfort or looks. This is partially because the market, though steady, is small, and the funding to advance prosthetics technology doesn´t flow as heavily as it does in, say, cancer research. There are about 1.8 million amputees in the U.S-mostly elderly stroke and diabetes patients-but the number of prosthetics users is significantly lower. Another inhibiting factor, of course, is the tremendous challenge of mechanically replicating the movement and dexterity of human limbs, which are as dependent on two-way communication with the brain as they are on the strength of bone and muscle.

But Halfaker and Stockwell were injured at an auspicious moment in the country´s attitude toward the prevention and treatment of limb loss. The nationwide support organization Disabled American Veterans has been lobbying for improved care for aging veterans hobbled by back and hip pain aggravated by poor-fitting prosthetics. Meanwhile, in Iraq, Kevlar vests and slick battlefield surgical units have kept more wounded soldiers alive (even if with missing limbs) than during any previous war. Government officials, keenly aware of the shoddy treatment given injured Vietnam vets-who often waited months for prosthetics-have vowed that these young men and women would not be treated the same.

In addition to the best care available now, that promise has sparked serious investment in the future. Don´t just think sockets and computerized body extensions, scientists are being told. Collaborate across fields. Explore every angle-even the regenerative powers of salamanders. In 2005 the Department of Veterans Affairs budgeted $7.2 million to create the Center for Restorative and Regenerative Medicine at the VA Medical Center in Providence, Rhode Island. This year the Defense Advanced Research Projects Agency-which has paid for everything from mine-hunting robotic lobsters to sleep-deprivation research-began funding two prosthetics projects for $48.5 million, hoping the teams will devise a stronger, more functional arm in two years and, in four years, a neurally-controlled arm with sensory capabilities and greater degrees of motion.

The ultimate goal: to create prosthetics that interact with the body, tapping directly into the brain´s desires and sending back progress reports. To do this, artificial limbs will need additional sensors to gather information on speed, angle, gait and balance. Improvements in metals, plastics and other materials will make prosthetics lighter, more flexible and more easily integrated onto the body. “It requires a kind of Manhattan Project” in terms of coordination and commitment, says prosthetics innovator Hugh Herr, director of the biomechatronics group at MIT´s Media Laboratory. Herr is a uniquely knowledgeable advocate for amputees, having worn two below-the-knee prosthetics for decades, since losing his legs to frostbite while ice climbing in New Hampshire as a teenager. “We’re at a time in history where there are many core technologies that are getting close,” he says. “And if there’s funding, there will be an opportunity for dramatic and profound innovation-what even Hollywood would view as bionics.”

Painstaking Progress

Before World War II, amputees wore static prosthetic attachments that were little better than peg legs. Then came complicated strap-, cable- and pulley-intensive mechanical arms, which opened a claw. By the 1960s, Soviet scientists had discovered that the amputee´s body has far more resources to call upon. Electrodes placed on the skin could detect a muscle´s myoelectric signals-its contractions-and transmit them to a battery-powered prosthetic, which would bend or straighten the arm. By the early 1980s, as the needs of injured Vietnam veterans spurred research, microprocessors allowed for gradations of movement and speed, rotation and flexion. Still, the stiff prosthetics make a series of many individual, sometimes jerky motions instead of executing seamlessly combined moves. The technology has advanced past the old myoelectric arms, which processed one signal at a time to move the elbow, wrist or hand. But even with simultaneous functioning of these controls, motions can be slow and require the wearer’s intense concentration. Simply doing dishes or getting dressed can be exhausting.

Prosthetic-leg wearers have seen more innovation than those needing arms, partly because there are more lower-limb amputations (95 percent of amputees), which means a bigger market for those working to improve the technology. Stockwell’s C-Leg, made by Otto Bock HealthCare in Germany, employs a microprocessor and hydraulics to enable the leg to swing forward automatically once a certain percentage of the wearer´s weight has shifted. The Icelandic company Ossur’s newer Rheo knee is similar to the C-leg, using a microprocessor to sense the knee´s position and load, which allows the leg to adapt to the person’s gait.

But these high-tech replacements can’t tell the wearer where the limb is in space. The devices act in mute isolation, unable to share information with the central nervous system, unable to grasp the user´s desires or even coordinate with the opposite limb. The only way to know whether the C-Leg has negotiated a curb is to look directly at the leg. “Your ankle talks to your other ankle-you´re distributed,” says Herr, one of the Rheo´s inventors. “Amputees are not yet distributed. So if I´m using the Rheo or the C-Leg, and I´m walking along and I see steps up ahead, I have no way to tell my knee that.”

Then there is the pain. Prosthetics can be heavy. If an arm socket is too tight, it pinches; too big, and the prosthetic leg feels unsteady. After six months with her C-Leg, Stockwell still moved in stages-torso, hips, legs-hating it when people stared. She decided to wear shorts, even in winter. “I’d rather they see my legs,” she explains, “than wear pants and have them wondering, ‘What’s wrong with her?'”

Bionics: We Do Not Have the Technology . . . Yet

The higher up the arm or leg someone is amputated, the more flexibility and range of motion disappears. Losing a foot is better than losing a knee; losing a wrist beats missing an elbow. Strip away multiple joints, and the body loses pronation, supination, abduction and adduction–those lovely, complicated multi-joint moves that allow people to sip iced tea or sidestep a pothole, moves that current prosthetics cannot mimic with ease.

As an orthopedist, Roy Aaron understands this. The Brown University Medical School professor was sobered every time he read about soldiers missing arms and legs. Here were lithe, active, determined people in prime physical shape. Years of wearing current prosthetics would leave them crippled with arthritis and other overuse injuries.

Aaron had time to think about this more deeply when his own body crashed. Confined to his bed for a few months in 2004 with a bad back, he dictated notes about a multipronged prosthetics project. The effort would marry tissue engineering, electronics, metallurgy, neurology and robotics, leveraging a toolkit of techniques to create hybrid limbs-part biological, part synthetic-that would one day allow amputees to move supplely and pain-free, their minds and bodies again working together as one. If researchers could replace the lost tissue and nerves and integrate the new flesh with smart, robotic prosthetics that could sense what their wearers´ minds and bodies wanted to do, Aaron thought, these young people could once again move with ease.

Aaron’s timing couldn’t have been better-his vision helped secure some of the new VA funding for the creation of the Center for Restorative and Regenerative Medicine. There, he´s finding ways to save damaged joints and extend the residual limb, commonly called the stump. His quest is for humans to mimic the axolotl, a type of salamander and the highest animal on the evolutionary scale that can regenerate a limb. “Cut a limb off, and he’ll just regenerate a whole arm or whole leg, toes and everything,” he says. “I’ve got to figure out how to talk to these newts and find out how they do it.”

But the marvelous future that this technology promises is too distant to help Halfaker, who worked with a custom-prosthetics designer at Walter Reed to fashion a limb that is light, realistic-looking-and otherwise utterly unfunctional. The designers made a translucent silicone socket liner that hugged her scar and was secured by a bra strap. Onto that they screwed an aluminum rod with tubing that could be bent into several positions. They then added urethane foam padding and, finally, stainless-steel fingers that can be bent into position. Her new arm was hand-painted by a former makeup artist with CSI: Miami to match her other arm, freckles and all. No motors, no sensors, no microprocessor. No utility except psychological: It would fill Halfaker´s sleeve and make her seem, at first glance, complete. “I want to look like I did before,” she says. “Who wouldn’t?”

Melding Body and Bionics

Of the many hurdles on the road to creating a Halfaker-friendly prosthetic, one of the most critical is the socket, the place where flesh and prosthetic meet. There have been plenty of socket innovations, including vacuum sockets that suspend the limb and suction sockets that add or remove fluid to maintain a consistent fit. But the best option would be to get rid of the socket altogether.

In 1952 Swedish orthopedist Per-Ingvar Branemark discovered that a titanium rod inserted in a rabbit´s bone fused well. He called it osseointegration, and the technique has worked wonderfully for dental implants, false teeth built on rods anchored in the patient´s underlying bone. In 1990 Branemark´s son, Rickard, an orthopedic surgeon at Sahlgren University Hospital in Gothenburg, Sweden, surgically implanted rods into human patients´ bones to act as a stable base for a prosthetic arm or leg. But several patients suffered complications. The skin never fused around the rod, acting as if it were a wound, and infections sprouted.

At Brown, molecular biologist Jeffrey Morgan and dean of engineering Clyde Briant are seeking ways to stop such infections. Briant is experimenting with titanium and alloys in search of a combination that is strong yet compatible with human tissue. Morgan is growing skin cells that will cling to the metal, forming a natural seal. It shouldn’t be impossible: “Brown students,” he observes, “have pierced noses.”

Once science figures out better ways to attach artificial limbs, prosthetics themselves need to become smarter, able to act on signals sent directly from the brain. Consider the case of Jesse Sullivan, a power lineman from Dayton, Tennessee, who lost both arms at the shoulder after being electrocuted on the job in 2001. A year later, doctors transferred four nerves (which were no longer infusing muscle) that had controlled his left arm out of his shoulder area and into his pectoral muscles. Six months after that, Todd Kuiken, director of the Rehabilitation Institute of Chicago´s Neural Engineering Center for Artificial Limbs, detected signals in the nerves. Kuiken´s team studded the surface of Sullivan´s chest with electrodes and joined them with wires to a multi-jointed prosthetic. The goal was to connect brain to artificial arm by redirecting signals from Sullivan’s severed nerves. It worked. When doctors asked Sullivan to think about opening his hand, the device, almost instinctively, sprung open. “It was the greatest feeling I’d had since I’d been hurt,” Sullivan says. He can now eat, mow the lawn, and do his laundry, but his arm fulfills only a small fraction of the nerves´ potential power. The nerve for hand closing controls at least 20 muscles, Kuiken says, “and I’m using it for just two different signals. If we tease it out, we might get better and better control.” Kuiken is now developing sensors that will allow Sullivan to feel what he is touching.

Another way to power artificial limbs is to bypass the nerves and tap directly into the brain. That´s what John Donoghue, director of Brown’s Brain Science program and the chief scientific officer at Cyberkinetics Neurotechnology Systems in Foxborough, Massachusetts, is working toward with the invention of BrainGate, a chip that was implanted in 2004 into paralyzed 25-year-old stabbing victim Matt Nagle. With the four-millimeter-square chip in his primary motor cortex, Nagle thinks about moving a cursor on the computer screen to the right. His neurons fire in a certain pattern, and those data are transmitted through a plug affixed to his skull to the computer, which moves the cursor. Soon, BrainGate´s developers got really ambitious. They lay a prosthetic arm, tethered to the computer, on Nagle’s lap and told him to open the hand. He did, just by thinking, and swore in amazement as the hand unfurled. Donoghue promises that future versions will operate wirelessly; Cyberkinetics is developing a control system that uses wireless transmitters and fully implantable power sources.

Fully Wired Limbs

In time, the brain will need to start hearing back from the prosthetics it’s sending signals to. It ordinarily receives a flurry of sensory feedback from a human leg-the terrain being navigated, the pitch of the incline-and can signal adjustments that need to be made. Next-generation prosthetics will be loaded with far more sensors than the Rheo and C-Leg have. They will pick up many, if not all, the cues that biological joints receive and be able to track their own pitch, forward thrust and spatial orientation.

But embedding prosthetics with sensors is useful only if those sensors can communicate with the wearer’s brain and spinal cord. The most promising middleman for such chatter is an invention called artificial nerve cells, or BIONs–”bionic neurons.” Developed by researchers at the Alfred E. Mann Institute at the University of Southern California, these implantable devices (centimeter-long glass capsules equipped with electrodes) have already been successfully injected in or near patients´ muscles and nerves to treat paralysis and to stimulate the limbs of stroke and arthritis patients. The researchers are now working on BION2, which will amplify existing nerve signals-sending instructions to the muscles and pr0cessing feedback from the limb-and might improve communication between a prosthetic limb, such as a hand with moving digits, and its wearer´s brain.

When these sensors determine that a leg needs extra power-for, perhaps, an uphill climb-they might operate in tandem with computer-controlled motors, also integrated into the prosthetic, to give the wearer a boost. Herr and his team have fashioned an “active ankle” that can behave like a spring or add or dissipate energy. His prototype has a motor in the ankle and a series of springs. The wearer would have wireless sensors implanted in his remaining leg muscle that would communicate with the ankle´s internal computer, augmenting power when needed. Herr has tried the device himself and describes it as equivalent to hopping onto a powered airport-terminal walkway. “If it were a product,” he says, “I would call it the Catapult.”

As all these technologies are refined, the artificial limbs will begin to look more and more like human limbs from the outside-and possibly even from the inside, as the human design is geared so well to its many tasks. Multi-jointed fingers will replace hands that have only three unjointed fingers, to achieve more naturalistic dexterity. Mechanical knees and ankles will become progressively more streamlined and efficient. Ultimately, even the means by which the joints are activated will become more humanlike.

Roy Kornbluh, a senior research engineer at SRI International in Menlo Park, California, has been experimenting with an electroactive polymer, also known as artificial muscle, that expands when voltage is applied and contracts when it´s turned off. “The more voltage, the more it stretches,” Kornbluh says. The process mimics human muscle, which changes shape in response to chemical signals.

Thinking Through Every Step

When a soldier loses a leg, she spends hours in physical therapy simply learning to stand. Stockwell started out on crutches. Next she stood using two canes. Then one. She stood on one leg. She stood and threw a ball. Finally, she stood on a C-Leg and hobbled down some parallel bars. In time, she walked free of bars. Then she pulled her seated physical therapist around the room, harnessed like a horse with some long stretchy Therabands. Running is the last step, the ultimate sign of the wearer´s success at managing body-machine mechanics. She had tried to run on a leg without an artificial knee, which forced her to kick with a circular eggbeater motion. The effort exhausted her.

Her prosthetist, Elliot Weintrob, had another idea. One brisk day in early spring last year, Weintrob, Stockwell and her husband, Dick, who is also a soldier, drove to a track in northern Virginia. Stockwell slipped into a socket consisting of an Ossur Total Knee attached to a bouncy Ossur Flex-Run Foot, a spring shaped like a large upside-down question mark. The knee could swing forward freely but did not have the C-leg´s ability to catch and lock if she started to fall.

“I’m scared,” Stockwell said to her husband. She tucked some hair behind her ear.

“You can do it,” he replied softly. They walked to a middle lane and he whispered in her ear, “Take off!”

She took six choppy long steps, her prosthetic leg flapping forward. Out of habit, she made the eggbeater motion. Weintrob pointed this out.

“I feel better,” she said hopefully. She started again, an awkward rise and collapse to her gait. She stopped, her face flushed, tendrils of hair twirling around her face. She started again. You could tell it hurt by the quick, short steps she took, her arms pinched against her body. She ran like she had stubbed her toe-over and over again.

Eventually, she got the hang of it. Months later, she managed to make her leg work well enough to compete in road races and triathlons, where she uses an arm-cranked bike. Last fall, inspired by her experiences, Stockwell began studying prosthetics at a Minnesota college, all the while convinced that her chosen field will ultimately become obsolete. A century from now, she says excitedly, prosthetics won´t be necessary: Doctors will be regenerating limbs!

At the track last spring, though, her back was sore, her backside was chafed, and she was tired of thinking about where to place her left leg next. “Every step,” she said. “I think about every step.”

The Boston Globe Magazine

The Bionic Arm

Posted on July 31, 2005 by Suzanne Sataline

It’s a medical marvel from one Midwestern doctor with the help of a tiny Massachusetts lab. A prosthetic limb that can be controlled simply by thinking it to move is giving hope to amputees returning from war.

The Bionic Man

By Suzanne Sataline
July 31, 2005
The Boston Globe Magazine

JESSE SULLIVAN HAD BEEN A POWER LINEMAN FOR NEARLY 23 years in Dayton, Tennessee, a quiet town of 6,000 people. It’s a much sleepier place now than it was 80 years ago, when a high school science teacher named John Scopes was tried for teaching the theory of evolution. On a May afternoon back in 2001, City of Dayton Electric assigned Sullivan to move an overhead wire. It was a routine task: Back-feed the power supply, clamp the line, install a switch. Sullivan had done it thousands of times. He glided up in an aerial bucket. At the top, for a reason that to this day he does not understand, Sullivan reached out and touched the power line.

He had forgotten to wear his rubber gloves. Seven thousand two hundred volts of electricity ripped through his body. Once. Twice. The current ricocheted off the sweat in one armpit, leapt over his chest, and sent a ball of fire tearing down his other arm. A surgeon would later find that Sullivan, then 54, had burned from the inside out – his bones heating up and searing his muscles and skin. The surgeon would have to amputate his arms at the shoulders, including the shoulder joints. His fishing friends would later joke that God had thrown their buddy back; he wasn’t a keeper. Sullivan is a religious man, and he knew there had to be a reason why he had been spared.

Sullivan had cheated death. No one would have denied him a sinecure at his rural home, wearing some off-the-shelf prosthetic arms as he puttered around his yard. But that choice would have limited him forever.

Sullivan’s loss was severe. The higher that the arm or leg is amputated, the more one’s flexibility and range of motion are lost. Losing a hand is better than losing an arm at the elbow, because the patient can still bend his arm and draw it toward his body. Losing an arm at the elbow is better than losing it at the shoulder. Sullivan had lost all of both of his arms. His body was a sheer cliff. Even the best prosthetic arms available would take him months to master, with no guarantee he’d ever be able to dress himself, shave, or sip a mug of coffee.

Dr. Todd Kuiken, a specialist at the Rehabilitation Institute of Chicago, learned of Sullivan’s injuries when he came to be fitted with conventional prostheses. After meeting him, Kuiken knew Sullivan was the perfect candidate for his work, the culmination of more than 20 years of research. Sullivan might not have his arms, but he still had working nerves in his shoulder area. And they were crackling with information. Kuiken thought their power could be harnessed to operate a prosthetic arm, so that Sullivan could, in essence, command a fake arm to move just by thinking about it. And because Sullivan had been right-handed, Kuiken wanted to put the new arm on his non-dominant side.

Sullivan would need a special prosthesis, one that was multijointed and powerful, one that would bend and extend with perfect coordination, as if it were a natural extension of his body. Kuiken, director of RIC’s Neuroengineering Center for Artificial Limbs, asked Sullivan to go under the knife once more. Kuiken then turned to the folks at a tiny lab in Holliston, Liberating Technologies Inc., manufacturer of the Boston Digital Arm System.

THANKS TO SEAT BELTS AND SAFETY STANDARDS, prosthetics manufacturing is a small, static industry. About 200,000 people wear artificial limbs, according to a 1994 tally (the latest available). Innovations come quietly – after all, patients can live long lives without arms and legs. Few scientists pursue prosthetics research, because the market is minimal and the government doles out little money, except during times of war.

With the war in Iraq, young men and women are coming home missing arms and legs, sometimes both. These soldiers, many of them better educated than those of past wars, want the most expensive and advanced prosthetics, in order to return to work and to active lives. Government agencies are paying research scientists millions of dollars to develop devices with computer chips and resilient fibers that are smaller, lighter, and more maneuverable than earlier devices. European scientists have attached artificial limbs directly to amputees’ bones with titanium rods, replacing uncomfortable silicone sockets. Researchers developing the BrainGate System, a project of Cyberkinetics Neurotechnology Systems Inc. in Foxborough, implanted electrodes into a quadriplegic, allowing him to bypass his severed spinal cord and operate a computer with his thoughts. “The convergence of technologies,” says Dr. Leigh Hochberg, a Massachusetts General Hospital neurologist and BrainGate investigator, “will have great potential to assist people with a large range of disabilities.”

The widget geeks at Holliston’s Liberating Technologies Inc. are just a few of the many crew members on a futuristic mission: to help a man move his artificial limbs as if they were the real things.

“I think what Dr. Kuiken is trying to do is push the envelope,” says LTI’s owner, Bill Hanson. “It was a lot to ask. [The Boston arm] was never designed to do all that, because nobody had ever done it before.”

ON A FRIGID JANUARY AFTERNOON THIS YEAR IN HOLLISTON, Craig Wallace glues electrodes to his thick arms and links the prosthesis that Jesse Sullivan will wear to a computer. It’s a battery housed in plastic molded to look like a forearm, in a color reminiscent of Crayola’s peach crayon. The plastic arm has a lifelike hand, flecked with painted-on hair. Wallace checks that the computer software is reading his own muscles’ electrical signals and correctly translating directions to the plastic arm. Wallace, an electronics designer, types on the keyboard. On the desk, the arm arches and the hand opens, then curls forward. The fingers splay out. It looks a bit like he’s operating Thing, the Addams Family‘s pet hand.

LTI has sold prosthetic parts for hundreds of children with birth defects, adults who have survived car wrecks, and workers injured on the job. The upper-limb market is minuscule – only 13 percent of the country’s estimated 1.2 million amputees wear artificial arms. Most of the research and therefore most of the stunning developments have focused on the larger leg and foot market.

“The upper extremities involve a spinal reflex and a higher level of human intent,” says MIT scientist Hugh Herr. Prosthetic legs are easier to develop and to use, in large part because “you can do an awful lot with just spinal reflex controls,” he says. In other words, to be able to pick up that cup of coffee involves thinking and acting on intentions. With walking, joints and muscles in the ankle perform almost instinctively.

Many of the biggest prosthetics developers are international corporations that buy the rights to projects nursed over many years by individual researchers at large universities like the Massachusetts Institute of Technology. Liberating Technologies Inc. started out as a project of the Liberty Mutual Insurance Co. and became an independent company four years ago, moving its arm molds, worktables, computers, and seven employees into a bland office park just inside Interstate 495.

While LTI is busy developing refined electronic prosthetics, it also repairs and provides limbs based on technology from the 1960s and ’70s. Sullivan uses a mechanical arm on his right side, which he prefers for tasks like writing. Mechanical arms with cable controls require the wearers to shrug and tense back muscles to move hooks.

“If your muscles weren’t strong enough or couldn’t master the technique, that was your problem. You had to conform to the system,” LTI’s Wallace says. “That’s all gone away.”

The Boston arm relies on another kind of muscle power: myoelectricity. When brain impulses stimulate a muscle to contract, the muscle generates a tiny amount of electrical energy. An electrode eavesdropping on the skin channels that impulse to the Boston arm. The arm’s microprocessor transforms that information into electric signals that can run arm, wrist, and hand motors. Technicians can program that microprocessor to bend or straighten the arm and open or close the hand at various speeds.

Soviet scientists developed the first myoelectric arm in the 1960s. It’s likely they took their cues from MIT mathematical genius Norbert Wiener, the man who founded cybernetics, the interaction of human and machine. Orthopedic surgeons at MGH discovered the Soviet experiment and, in Cold War style, wanted an arm of their own. Thus began “the most politically-intrigued project that I have ever witnessed at MIT,” says professor emeritus Amar Bose, founder of Bose Corp., of Framingham. To this day, the participants grouse about who deserves credit. Bose says that after a few years, he quit the project in disgust.

For two years in the early 1960s, Wiener and Bose, along with surgeons at MGH and a few others, drew up plans for their own myoelectric arm. Bose says Wiener drove the project. “We were like technicians carrying out the invention of the man,” Bose says. By 1967, MIT professor Robert Mann and his graduate engineering students had fashioned an experimental design, funded by workers’ compensation carrier Liberty Mutual. More prototypes were made, and, in 1973, the company hired physicist T. Walley Williams III to transform one of the devices into an elbow that could be marketed.

Williams teamed up with Bill Hanson in 1984. Hanson was a young MBA graduate, and he hit it off with the effervescent, Latin-spouting, world-traveling Williams. They continued developing the myoelectric arm for Liberty Mutual until the company decided to sell off some of its research subsidiaries in 2001. Hanson then created Liberating Technologies, making Williams its product development director.

By then, Hanson had met many amputees and had made it his mission to help the injured return to work. He is riled by tales of insurance companies that refuse to pay for prosthetics. In Massachusetts, a bill is being considered that would require private insurers to match Medicare’s coverage for artificial limbs by paying 80 percent of the cost. “People like to be productive,” says Hanson, 58. “They like to feel useful.”

Initially, workers’ compensation paid for Sullivan’s medical costs. Kuiken’s current work is funded by the National Center for Medical Rehabilitation Research, a program of the National Institute of Child Health and Human Development.

The Boston arm has benefited from the digital revolution, allowing users greater control and range of motion. Still, it is not a replacement for a real arm. Prosthetics operate stiffly, making distinct, sometimes jerky motions. Older myoelectric arms read one signal at a time, and wearers had to switch controls from the elbow, to the wrist, to the hand. Three years ago, the LTI staff introduced technology on the Boston arm allowing for simultaneous control and more natural movement. Williams, 73, wants people “to control elegantly. We’re trying to get people to do things the way they did before their arm was lost.”

MANIPULATING AN ARTIFICIAL ARM REQUIRES A DANCER’S physical discipline and a chess player’s mental focus. Most amputees operate their artificial arms through a combination of muscle might and battery power. But the motions are slow and require awkward mental gymnastics, such as having to think about tensing the forearm to open the hand. Kuiken wanted to use Sullivan’s existing arm nerves to control his myoelectric arm. The doctor knew that the ulnar, median, and other nerves would still operate as if Sullivan’s arms were there, even if the nerves were surgically rerouted to muscles in his chest. When Sullivan thought about closing his hand, his brain would still fire his median nerve, and his chest muscle would contract, signaling the Boston arm to operate the hand.

To use the Boston arm, Sullivan needed more surgery, and there would still be no promises. But he was determined: “I wanted an arm that worked.”

In 2002, Dr. Gregory Dumanian, a surgeon at Northwestern University Medical Center, transferred from Sullivan’s shoulder area to his pectoral muscles four nerves that at one time had controlled his left arm. Six months later, Kuiken detected signals in the nerves. In January 2003, Kuiken’s team fit Sullivan with the Boston arm, wrist, and hand. Prosthetics technicians taped electrodes to Sullivan and asked him to think about opening his hand. The artificial hand popped open. “It was the greatest feeling I had since I’d been hurt,” Sullivan says

With his new arm, Sullivan could rake leaves, start the lawn mower, even feed himself, although it took time to learn how to eat soup. But challenges remained. He had to rely on his wife, Carolyn, to open a jar or tie his shoes. He longed to drive.

Last year, Kuiken wanted to see how much more information he could coax from Sullivan’s nerves. Three other amputees had had nerve-transfer operations, but Sullivan, the first, was farthest along. As always, the patient was eager to try more. “He’s a saint,” Kuiken says.

Kuiken’s crew obtained an experimental setup: a powered shoulder unit, along with an arm rotator and a hand with wrist-flexing and wrist-rotating abilities. Kuiken asked LTI to soup up a Boston arm that would let Sullivan bend his elbow, swivel his arm in and out and raise it over his head, rotate his wrist, and grasp. It wouldn’t quite make him the new $6 million man, but certainly someone worth tens of thousands of dollars.

IT’S THE FIRST MORNING IN MARCH OF THIS YEAR, AND A BEVY OF technicians and researchers swirls around Sullivan in an exam room on the Rehabilitation Institute’s 17th floor in Chicago. Sullivan is standing with a wry smile while people paste electrodes to his chest and the experimental arm is locked onto his left side. He winks at himself in the mirror.

He has a soft belly, spindly legs, and shaggy hair just starting to gray. He misses hugging his wife and compensates by throwing the empty arm of his leather jacket over her shoulder.

At last, everything is ready. Laura Miller, the certified prosthetist, watches signals on a laptop computer.

“Close hand,” she calls out. The hand snaps shut.

“Can you lower the arm?” The shoulder motor grinds as the arm jerks down. Miller adjusts the motor’s speed with the computer.

“Bend elbow?” It kinks. Sullivan’s chest muscle pulses.

“Close?” The elbow flies up.

“Don’t force it,” Miller guides. “Do a gentle open.” The elbow flexes.

Hanson, the owner of LTI, smiles.

Sullivan grows eager. His straightened arm begins climbing toward the ceiling. Higher, higher, the hand swiveling out.

“Taxi!” Sullivan calls, raising his eyebrows. “Taxi!” Standing nearby, his wife, Carolyn, bursts out laughing.

Sullivan tests the arm for two weeks. When he returns to Tennessee, his arm stays in Chicago for more development. In 2003, Kuiken discovered that when Sullivan’s scarred chest was touched, he felt sensations in his missing arm. Last month, Kuiken placed sensors on Sullivan’s prosthetic hand and wired them to a plunger device on his chest. The hand sensors trigger the plunger, which presses against Sullivan’s skin, allowing him to “feel” how hard he is gripping something.

The team’s work has excited other scientists. “In terms of the importance to the field of prosthetics, it’s enormous,” says Bernard Hudgins, director of the Institute of Biomedical Engineering at the University of New Brunswick and a longtime research leader in the field. “We’ve never had a major advance in the technology until Todd [Kuiken]’s work.”

Others caution that science and industry are years from offering a similar arm to all amputees. The unit needs to be lighter and to be rigorously tested. And for an arm to be truly lifelike, it would need to have a hand with movable fingers. Doctors would have to tap multiple sites within a muscle or tease complex signals from a nerve or even the brain – work that is years away. And there’s a time limit: A year after amputation, nerve signals may start to grow faint.

Back at the Holliston office, Hanson gets a new video of Sullivan using the arm. The robotic stuttering is gone. Sullivan bends his elbow while lifting his shoulder, unfurling his arm as if he’s reaching out to shake someone’s hand. Hanson calls his staff in to watch. “No amputee, no prosthetic system has moved like that,” he says later. “It’s the kind of movement we’ve always been hoping to get but never were able to get.”

Sullivan says his arm is no longer an experiment. “I feel my own hand. In my mind’s eyes, they’re there.” He can’t wait to take the newest arm home; it is, after all, a part of him.