Neurology

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Injured? Horsing Around With Stem Cells May Get You Back in the Saddle

Doctors might soon be able to regrow injured muscles, tendons and bones without invasive surgery, simply by injecting a person's own stem cells into the site of an injury. Veterinarians are already doing it with injured horses, and research into human applications is well under way. The National Institutes for Health seem to think regenerating human muscle and bone using a person's own adult stem cells is nearly ready for prime time. Last week, the NIH announced to its staff that it's creating a bone marrow-stem cell transplant center within the National Institute for Arthritis and Musculoskeletal and Skin Diseases. Researchers at the NIH labs in Bethesda, Maryland, are already growing human muscle, cartilage and spinal disks in vitro. The tissue isn't mechanically sound yet, says lead researcher Rocky Tuan, but that will come with further work. "I have a piece of tissue that looks like a spinal disc, a sand bag, tough as nails on the outside and like sand on the inside," says Tuan, a Ph.D. and the senior investigator in the Cartilage and Orthopedics branch of the NIAMS. "The mechanical properties are lousy, but it's a beginning." While the use of stem cells harvested from human embryos has been getting the most media attention, scientists and doctors have also been working with adult stem cells that also have the ability to become one with their environment and to replicate as cells of their adopted tissue. Using adult stem cells -- grown inside the body or in the lab -- has become accepted in the veterinary community, and horses have benefited greatly. Researchers are working to bring those same benefits to humans, but there are still hurdles left to clear. The NIH project comes in part from what veterinarians have learned from injecting adult stem cells into valuable horses who've suffered injuries. In many cases, those horses' careers were saved when the stem cells regrew damaged tendons and ligaments. Rodrigo Vazquez, a Southern California veterinarian, has been using adult stem cells to regrow damaged muscles in horses for several years. It's a fairly common procedure in the veterinary arena, and the results are impressive: One of Vazquez's patients is participating in this year's Olympics Dressage events; another is a prize-winning jumper. The procedure is simple and straightforward. Inside a surgical suite at his equine hospital, Vazquez removes blood full of adult stem cells from the sternum of the anesthetized horse. Then he rolls his stool to the other end of the horse, where ultrasound data has helped guide needles into the exact areas on the rear leg where the beautiful horse's ligaments are torn. He injects the stem cells into those spots. "A few years ago, these injuries were career-ending," Vazquez says. Not any more. "In a month, the torn tissue will be completely regrown and healed." Vazquez would like to put himself in his patients' place. He has had surgery several times for spinal injuries he incurred while lifting horses. Human medicine, unable to regrow or heal the injured spine, simply fuses the bone and tissue through a surgical procedure. At best, the surgery relieves some of the pain and restores some mobility. But it's not a true repair. "I wish I could have had a procedure like this," Vazquez says of the treatment he gives horses. "This will lead to human treatments, but they can't move as fast as we can." Tuan, who is using stem cells to cultivate experimental tendons and disks in his lab, thinks it's about time to look to treating humans. An emerging body of scientific studies from all over the world -- including a cardiac study under way in Miami and a pediatric ACL (anterior cruciate ligament) study at the Harvard-affiliated Children's Hospital of Boston -- is showing that using a patient's own stem cells can prompt the growth of new muscle, from the knee to the heart. And the precursor step, using platelet-rich plasma for injuries, is on the verge of becoming mainstream. Adult stem cells, particularly mesenchymal cells that come from muscle, bone and fat, are cells with a powerful ability to replicate and not a lot of personal identity. They easily take on the characteristics of surrounding cells and they tend to grow quickly once they get there. Ultrasounds of Vazquez's horses, for example, show regeneration of muscle in four to six weeks. The final product is this cartilage-like tissue grown around the scaffolding by NIH scientists. Tuan says the tissue resembles the human version, but may not be mechanically sound -- yet. Courtesy NIAMS Adult stem cells can be found all over the body, in bone and marrow. Tuan says they're also found in tonsils and in the placenta and umbilical cord, which suggest that the discarded body parts can be stored for later use. Because researchers are using autologous cells -- from the patient's own body -- the research is not controversial. No one has challenged the ethics or funding of adult stem cell research the way embryonic stem cell studies have been challenged. And because adult stem cells are native to the patient's own body, the chances of a patient rejecting them are slim to none. Tuan and his team have been able to coach adult stem cells to form muscle and disks using goo from the small intestine and a polymer scaffold to tell cells how to grow. But, he cautions, the primitive structures aren't ready to go into humans. "After a few weeks (of lab growth), it will turn into something that resembles a tendon, but it has to be the mechanical equivalent and we don't know that we're there," Tuan says. "Stem cells are very promising, but what they do for horses may not work so well for humans because humans are the hardest animal to rebuild." Once they're perfected, Tuan sees a day when the tendons will change the dreaded surgery for torn anterior cruciate ligaments that sideline up to a quarter-million people in the United States and Canada every year. "Often, that injury is a complete tear -- the ligament is snapped in two and the ends ball up and even if you untangle them and pull them together, they won't heal," he says. "So they take part of the patella tendon, which is short and tough, and stretch it and staple it to the bones. So not only is your ACL not working too well and you have to stretch it out, but your knee hurts like crazy." "If we can learn to grow a tendon that works right, or figure out how to make the ACL heal back together, we can save a lot of people a lot of pain," he says. In fact, doctors are already treating people with adult stem cells. Bone marrow transplants for cancer patients are basically stem cell therapy. But the marrow often comes from other people, and its primary purpose is to boost a weakened immune system, not to generate tissue. And treating with platelet-rich plasma -- a blood product made by spinning a patient's blood in a centrifuge to concentrate the platelets -- is already in limited use and is becoming more widely accepted as a safe therapy. PRP is routinely used in cardiac surgery, where applying it to a cut sternum before closing has been shown to cut the infection rate in half. The plasma has growth factors that also promote healing. "PRP helps recruit stem cells to the injury," says Dr. Allan Mishra, who has used PRP on its own and as part of surgery in sports injuries -- including treating tennis elbow and getting Stanford football player James McGillicuddy's patellar tendon to heal after his second surgery. "The body knows how to heal itself -- we're speeding up and concentrating the process." Last year, Mishra wrapped up a study where he used platelet-rich plasma to treat the 20 worst tennis-elbow injuries he'd culled from more than 100 volunteers. "Ninety-three percent got better with a single injection and stayed better for two years," Mishra says. The treatments are about one-tenth of the cost of surgery, or about $2,000 to $2,500, he says. The patient's blood is drawn, centrifuged by a specialist called a perfusionist, and injected, all in one visit. "I will guess that five years from now, insurance companies won't authorize surgery until the patient has tried and failed at PRP." The obvious next step is to isolate the stem cells and send them to work, both inside and outside the body, researchers say. "PRP is reparative. Stem cells are regenerative," says Angela Nava, a perfusionist who processes both animal and human blood for PRP, stem cell and other procedures. But getting from animals to humans is going to take a lot more research, according to Dr. Thomas Rando, an associate professor of neurology at Stanford University School of Medicine. Rando studies the body's signaling systems that tell stem cells what to do. "We don't always know how stem cells, when injected into some tissues, work their magic," Rando said. "Veterinarians don't go back and study the horse's tendons to figure out what the stem cells did to promote healing." "There are all kinds of ways stem cells could work. If we could understand how they are actually promoting better function of the tissue, we might be able to further improve their therapeutic effects," he adds. Stem cell treatment is not without risks, researchers say. The worst-case scenario is that the stem cells could cause cancer -- or become cancerous themselves. "You're putting in cells that want to grow. That has to be under control," Rando says. "Or we can end up with cancer." Tuan also says that researchers don't entirely trust stem cells and their ability to adapt and grow. "There's a nagging feeling that there's a cancer stem cell, that when it's agitated by exposure to carcinogens or radiation or something, it goes nuts, and that we can't identify it from the other stem cells," he says. "How do you find this bad boy and pull him out? "And there's a nagging worry it's the same cell. We only know these cells by what they've done, and by the time they've become cancer, it's too late."

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Drug Companies Get Healthy, but at Whose Expense?

News from Portfolio.com Also on Portfolio Esquire, E-Ink: Future of Print? Hollywood's Sudden Cash Crunch Even Conservatives Hate Michael Savage Subscribe to Portfolio magazine Trevor Foltz was six months old last fall, fresh off a visit to Disney World in Orlando, when the spasms first began. Healthy until that point in his life, he began thrusting backward in his car seat, repeatedly and forcefully, as he rode with his parents north toward home in Rhode Island. "I thought it was temper tantrums," says his mother, Danielle. The next day, at home, Trevor was hit with a series of 40 convulsions and rushed to the hospital, where he was diagnosed with infantile spasms, a rare form of epilepsy. Treatment would cost $1,600 per vial of steroid drug H.P. Acthar Gel, and Trevor would need three of them. As if the idea of a $4,800 tab wasn't bad enough, when the Foltzes submitted their claim, they found out the company that made the drug, Questcor Pharmaceuticals, had just recently jacked up the price?to $23,000 per vial, or $69,000 for a three-vial treatment?and the insurance company wasn't going to pay. And all the while, unbeknownst to anyone at that time, an alternative, for $15, existed. On Thursday, the Joint Economic Committee will open hearings in Congress on dramatic price hikes for drugs used to treat children, with a focus on companies such as Questcor and Ovation Pharmaceuticals, which in 2006 bought rights to a drug that treats heart problems in premature infants, and increased the price 1,800 percent to $1,875 per three-vial treatment. "We need answers to why a company would increase the price of a drug 18-fold when costs related to marketing, physician education, and research appear stable," says hearing chair Amy Klobuchar, a Democratic senator from Minnesota. Politicians say they are not opposed to drug companies earning strong returns on the costs of researching innovative drugs, and understand the high prices of many medications. But they are investigating whether some companies are price-gouging, concerned more about executive stock options than about running innovative companies. Some of those drugs, like Questcor's, are decades-old drugs that were bought on the cheap and redesignated under the federal government's Orphan Drug Act, which marks its 25th anniversary this year. Not infrequently, the drugs' new owners pass on big price hikes to consumers. At Questcor, the increase is explained as the cost of doing business with an orphan drug. "The company was heading toward bankruptcy," says Steve Cartt, executive vice president for business development at Questcor, which is based in Union City, California, an industrial enclave on San Francisco Bay. "The whole rationale for the price increase was to ensure availability of the product," says Cartt. "We talked to physicians. They wanted the drug to be available. The choice was risk of availability or a price increase." Originally approved for multiple sclerosis in 1952, Acthar Gel had been owned by pharma giant Aventis, which was losing money on it, when the 11-year-old Questcor acquired it in 2001. Questcor, too, failed to gain traction with M.S. patients, so it sought a new track. Now the gears at Questcor began to turn more quickly. It won orphan designation for Acthar Gel in 2003, and proceeded to the next step: getting F.D.A. approval to market the drug explicitly for infantile spasms, which under the orphan act would also include a seven-year monopoly for Questcor. The company prepared for a marketing blitz and doubled its sales force early last year. But when the F.D.A. rejected Questcor's application in May 2007, the company quickly slashed its staff and jacked up the price. Cartt says the price was set "within the range of other orphan drugs," noting that many others go from $50,000 to $500,000 a year or higher. For instance, BioMarin, an orphan-drug specialty company, charges $70,000 a year for Kuvan, a drug to treat phenylketonuria, a genetic enzyme disorder that can cause mental retardation and brain seizures. But unlike BioMarin, which spends 64 percent of sales on research and development, Questcor spends very little; in 2007, Questcor's research and development accounted for 9.5 percent of sales revenue. What other considerations played into the price Cartt would not say. Sales for 2007, when the price hike took effect, were $49.7 million, and net income was $37.5 million?a net profit margin of 75 percent. It was significant not only for its size, but also because it was the first profit since the company was formed, as Cypros Pharmaceuticals, in 1990. Investors were pleased, driving up Questcor's share price from 40 cents to over $6 after the August 2007 price hike. But executives at the company started selling their shares in December, seven months after the former C.E.O., James Fares, stepped down and around the time Questcor executive Don Bailey took his place. Since December, Cartt himself has sold shares based on grants and options totaling $1.68 million; many of those options were granted at 46 cents a share. He holds nearly a million more options on Questcor stock. Doctors were unhappy with the price hikes. "Most of us in the child-neurology community were outraged at the extent of the price hike, unusual even for orphan drugs," says Eric Kossoff, a pediatric neurologist and infantile spasms expert at Johns Hopkins Children's Center. "Most of us had no choice, unfortunately. At the time it was felt to be the best drug out there, and they're the only company that makes it. This is an incredibly serious form of epilepsy with devastating implications if not treated." Curiously, though, he found that the price hike "was one of the best things that could have happened." Why? "Because we found something better and cheaper." Far cheaper, it turns out. "We spent a few days going through all the medical literature, looking for what works, what doesn't." The team turned up a study from the United Kingdom that gave infants high doses of prednisolone, a well-known, generic steroid. Prednisolone had been dismissed as relatively ineffective for infantile spasms-based research that used low doses. The high doses made all the difference: The British study found efficacy rates reached 70 percent and more. Johns Hopkins began using high-dose prednisolone and found it worked in about 70 percent of cases, on par with the hospital's experience with Acthar Gel. And the price was $15 per injection?essentially free?compared with the three-injection $69,000 treatment from Questcor. "It was like in times of war. You get focused, and amazing things come out," Kossoff says. "We don't use [Acthar Gel] at Hopkins anymore for infantile spasms because the oral steroids [high-dose prednisolone] work just as well." It's unclear, though, how many other doctors and hospitals in the U.S. will switch from the $69,000 drug to the $15 drug. "I don't understand what's behind the price increase," says Finbar O'Callaghan, a pediatric neurologist at the Bristol Royal Hospital for Children and coauthor of the United Kingdom Infantile Spasms Study, or UKISS. The study showed that high-dose prednisolone and a synthetic form of ACTH, the active hormone in Acthar Gel, were equally effective. He cautioned that the purpose of the study was not to compare the two, but to compare steroid treatment with another drug called vigabatrin. "Having said that, you couldn't get a piece of paper between the results of the prednisolone and the results of the ACTH." Costs aside, Hopkins is achieving the same results against Acthar Gel. "There is no reason to favor one over the other, unless there is a financial reason for doing so. That's been a big issue in the U.S.," says O'Callaghan. Comparing $15 against $69,000 "puts a different perspective on it," he says. "Historically, and unfortunately," he adds, "doctors in general are very traditional and tend to use what's worked before." Asked about the $15 price on prednisolone, Cartt said studies from the 1990s show low efficacy rates for the drug. When informed that those studies looked at low doses, not high doses, Cartt said no one knows the long-term implications of high-dose prednisolone, and said the company's higher profits will help it find out. "We can afford to study the long-term effects" of Acthar Gel and the alternatives, he said. What the congressional hearing may find is that Questcor had a business problem: While its drug had a potential market of 300,000 multiple sclerosis patients, not enough of them were buying. But among a smaller market, just 2,000 babies per year, Acthar Gel was extremely effective in fighting infantile spasms. Questcor's astronomical rates may simply be a matter of hard business realities in a small potential market. For the Foltzes, Questcor's high prices proved irrelevant, after much struggle. When at first his insurance company, WorldWide Insurance, rejected the claim, Trevor's doctor faxed in a letter stating that there was a good chance Trevor would end up mentally retarded for life without treatment; the insurer relented. But on Thursday, his mother, Danielle, will join those who testify against companies like Questcor. She says, "I feel they're going to soak every penny if they can get it."

New Welsh neurology unit planned

A new neurology unit for patients in north Wales is planned as the go ahead to continue using an English centre is given.

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