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Colon: Received stem cell Before New York Yankees infusion. pitcher Bartolo Colon pulled his hamstring while running from the mound to first base on June 11, fans would have been forgiven for thinking he had chugged from the Fountain of Youth. Colon has not completed a full season since 2005 and sat out 2010 to rest his aging and injured right arm. But this season, his fastball is back. His ERA, 3.10, was among the tops in the league. On May 30, six days after his 39th birthday, he pitched his first shutout in five years, hurling his final pitch at 95 mph. What lit the fuse on his fastball? An infusion of stem cells, says Joseph Purita, founder of the Institute of Regenerative and Molecular Orthopedics in Boca Raton, Fla., who gave Colon the controversial treatment in the Dominican ReBy Steve Sternberg USA TODAY
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Extracting cells: Joseph Purita says he limits stem cell procedures to orthopedics.
public before baseball season began. Purita isnt the only doctor offering patients stem cells. Doctors in the U.S. and abroad are now providing untested and unapproved stem cell therapies for ailments from heart dis- COVER ease to emphysema to cerebral STORY palsy. And they swear by them. Heres a guy who was fooling around for two years and not getting any better. All of a sudden, you do this procedure and a few weeks later hes dramatically better, Purita says. There must be something going on here. Experts liken stem cells to the seeds from which many body tissues grow. If scientists can harness stem cells in healing, researchers say, they can revolutionize medicine. Embryonic See COVER STORY next page u
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The number of fatal bus accidents such as the one that killed former college basketball hero Lorenzo Charles Monday in North Carolina is much higher than the government reports, a USA TODAY review of government records and news reports finds. Some of the most disastrous motor coach accidents of the past decade including a widely publicized crash in Tallulah, La., that killed eight people in 2003 arent included in statistics of fatalities from the National Highway Traffic uDefinition of Safety Administration motor coach can (NHTSA), the govern- skew data, 2A ment agency responsible for tracking accidents. USA TODAY found the agency has undercounted motor coach accidents and deaths on the nations highways since at least 1995 and has given the inaccurate numbers in testimony before Congress and in public reports on bus safety. The agencys failure to track all the accidents has given Congress and the public a false impression that buses are safer than they are and has thwarted efforts to promote tougher regulation, safety advocates say. By underreporting crashes and fatalities, it has given the industry the political cover they want to go to (Capitol) Hill and say, We are really safe, says Jacqueline Gillan, vice president of the Advocates for Highway and Auto Safety. Sens. Sherrod Brown, D-Ohio, and Kay Bailey Hutchison, R-Texas, who have co-sponsored legislation to improve bus safety, say theyre troubled by the discrepancies in the NHTSA statistics. Hutchison vowed to look into the matter. Lorenzo Charles, who scored the winning basket for North Carolina State University in the 1983 NCAA championship game, died Monday when the motor coach he was driving went out of control on Interstate 40 in Raleigh, N.C. His death brings to 25 the number of occupants who died in motor coach accidents since March. This years accidents have driven the issue into the news and prompted congressional hearings. USA TODAY found at least 42 deaths of motor coach occupants and drivers were not reported using NHTSAs standard definition of a motor coach from 1995 to 2009, the most current year for which data are available. Since 2003, 32 fatalities were not included, which represents a 24% increase from the 133 deaths the agency counted. In addition, there were 42 deaths from 2000 to 2009 on midsize buses, which are not counted by the agency as motor coach fatalities. The NHTSA data suggest that motor coach crashes and fatalities have surged in recent years even as highway deaths as a whole have fallen 25% since 2005. Regardless of the number of deaths, the Obama administration has aggressively tried to improve motor coach safety, Department of Transportation spokeswoman Olivia Alair says. The government has doubled the number of surprise inspections of buses, and last year, it proposed requiring seat belts on motor coaches. NHTSA spokeswoman Lynda Tran says the agency is working with state officials to improve the quality of data it receives on accidents. Contributing: Luke Kerr-Dineen
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known as Cross Country/Intercity Bus. Motor coaches are sometimes listed under other categories. To some extent, NHTSA officials are hostage to the information they receive from local authorities. The agency has tried for years to improve the data reporting, holding training sessions for state officials who code the data. Mistakes still occur. In the case of the Tallulah crash, the accident is listed under the category Unknown Bus Type. The NTSB labeled the bus a motor coach in its investigation and in a recommendation to NHTSA. The accident that killed Ashley Brown reveals another issue with the FARS data. The bus carrying her soccer team was a slightly smaller bus the NTSB labeled midsize. The NTSB says these buses perform trips nearly identical to the ones by motor coaches and have similar safety deficiencies. Investigators found 33 occupant deaths from 2000 through 2008 on these buses. None of these cases was included in the NHTSA motor coach data, the NTSB said. Nine additional deaths in these buses occurred in 2009, USA TODAY found. Its shocking to hear that this accident is not accounted for in determining whether to make changes in how we regulate transportation, Brown says of his daughters crash.
Food and Drug Administration. But FDA regulations have loopholes, Goldstein says. FDA guidelines limit its authority to regulate treatments involving cells that are withdrawn from a patient and then infused the same day with only minimal manipulation. Last August, in a test of its authority, the FDA requested an injunction from the U.S. District Court in Washington, D.C., to block a Broomfield, Colo., orthopedic clinic, Regenerative Sciences, from formulating treatments of cultured stem cells. The clinics medical director, Christopher Centeno, says he has repeatedly sued the FDA, arguing that these treatments fall within FDA guidelines for the practice of medicine. The FDA countered with its own lawsuit. The dispute wont be decided until 2013, Centeno says. FDA declined to comment because the case is pending. Centeno says he is trying to move stem cell therapy into the mainstream. He helped establish the International Cellular Medicine Society, which drafted guidelines for stem cell treatments and promotes responsible research, he says. The group does not yet accept members, but about 1,500 people, half of them doctors and half patients, have signed up for information, says David Audley, the groups executive director. Two clinics in the U.S. are going through the groups stem cell accreditation process. The groups goal, Audley says, is to assure patient safety, by tracking patients for up to 20 years through a patient registry. At this point, we dont have enough data to talk about true efficacy, he says. We would love to get into efficacy.
Buyer beware
Buyer beware, warns Daley, who is also the head of the International Society for Stem Cell Research, an academic group that posts a cautionary handbook for consumers on its website. On one hand, he says, there are charlatans selling snake oil. At the other end of the spectrum are physicians who may be well intentioned, but theyre misinformed if theyre giving patients stem cells before theyve been proven to work. Many patients say they cant, or wont, wait years for scientists to gather evidence, as long as
there are doctors willing to treat them now. Barbara Hanson, founder of the online discussion forum Stem Cell Pioneers, says stem cells have allowed her to rebound from life-threatening pulmonary disease and resume an essentially normal life. Were not going to sit here and just die, and wait for the FDA to give its stamp of approval for us to have our stem cells used, she says. Clinics are flourishing in the USA, Mexico, China, India, the Dominican Republic, Thailand, Russia and the United Kingdom, says Tim Caulfield, a University of Alberta, Canada, law professor who has studied direct-to-consumer Internet marketing of stem cells. Caulfields team found that most websites play up the benefits and downplay the risks of stem cell therapy. The average cost of care: just under $50,000. Nearly half of those treated were under 18, he says. Parents often fly children to clinics in other countries for untested stem cell treatments for such ailments as autism and cerebral palsy. It makes me angry, he says. Theyre trading on the excitement of stem cells to market these therapies all over the world, for everything you can think of, including autism, multiple sclerosis, blindness, heart disease, cancer, neurological disorders, even aging. I regard that as a marker for quackery. If they treat everything, you know its too good to be true. Increasingly, doctors find themselves treating critically ill patients who sought stem cells first. Cleveland Clinic heart specialist Wael Jaber says he was astonished when a 75-year-old patient told him he paid $50,000 for stem cell treatments to heal his ailing heart. Two Mayo Clinic lung experts, Charles Burger and Neal Patel, say a pair of their patients paid roughly the same amount for stem cells to treat a deadly lung disease. They paid cash, 50 to 60 grand, in advance, Burger says. Medical tests showed that none of the three benefited from the therapy, Jaber and Burger say. Jaber says his patient who had triple bypass surgery June 1 sought his stem cells at The Brain Therapeutics Medical Clinic in Mission Viejo, Calif., run by osteopath David Steenblock.
A story Tuesday on an Afghanistan offensive misidentified the location of a U.S. outpost overrun in 2009. It was in Nuristan province. A graphic Tuesday on the final launch of the space shuttle incorrectly listed possible space shuttle landing sites. Only Florida and California are possible landing sites. In some editions Tuesday, a front page item about Beyoncs new album should have said the review was on page 7B.
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