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Roll out the royal carpet

Smooth opening
USA's Rachel Buehler celebrates her goal. By Marcio Jose Sanchez, AP

USA savors 2-0 win over North Korea as it begins World Cup play, 1, 10C

Prince William and Catherine are ready to make their first official visit to the USA, 5D
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Protesters attack police in Athens. By Aris Messinis, AFP/Getty Images

Greece sees new outbreak of rioting

As the parliament debates measures to avoid bankruptcy and secure loans, a national strike turns ugly, 6A

Not all fatal bus crashes counted

Social Security payments are at risk by debt impasse

If government cant raise debt limit by Aug. 2, disabled and retirees may not get payments. 5A.

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

By Eliot J. Schechter for USA TODAY

EPA sets rules for new fuel mix E15: 15% ethanol, 85% gas
Fuel, which could show up at stations this year, might damage vehicles made before 2001. 1B.


Doctors across globe offer unapproved therapies

Extracting cells: Joseph Purita says he limits stem cell procedures to orthopedics.

U.S. statistics miss at least 42 deaths

By Alan Levin USA TODAY

Palin steals the show in Iowa

Former Alaska governor attends premiere of film about her, but is mum on whether shell run. 5A.

U.S. home prices up in April

Spring buying boosts industry, but economists not ready to say market has bottomed. 1B.

Gamecocks are champs again

South Carolina wins College World Series. 1, 7C.

NHL team-by-team schedules

The where and when for the 2011-12 season. 8C.

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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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Hit the beach at your own risk

The data are from 2010, but Beckman says risks of unhealthy water can continue in 2011, depending on weather. Often after a rainstorm, youll have a beautiful day and you wont see the By Dan Vergano bacteria growing in the water, he says. USA TODAY The Environmental Protection Agency estimates that beaches host 2 billion visitors a year. Skip beaches after rainstorms and avoid swim- Beach monitoring tests look for fecal microbes ming near storm drains, says an environmental that cause stomach illnesses. group that today releases its asStorm runoff is the main reaSee how 200 popular son beaches see spikes in offsessment of the nations best and U.S. beaches rate worst beaches in 2010. shore bacteria that lead to closat Stormwater and sewage, along ings, says environmental biolowith the Gulf of Mexico oil spill, gist Rachel Noble of the University of North Carowere culprits in a 29% increase in beach closings lina, who was not part of the report. One caution and health warnings last year, the Natural Re- is that some states do more testing than others, sources Defense Council says. People need to which might make them look worse, Noble says. take a look at their beachs water quality, along Beckman says the NRDC report includes testing with packing the sunscreen, the NRDCs David frequency in rating 200 popular beaches nationBeckman says. Beaches that dont tell you their wide. They include four superstar beaches with conditions might make you more cautious. unblemished water-quality results since 2006. The report compiled state and federal data Two are in Delaware, one in New Hampshire and from nearly 3,300 beaches and found more than another in Wisconsin. 24,000 days of closings or advisories at ocean or We deserve it, says City Manager Gregory Great Lakes beaches. The group concludes that Ferrese of Rehoboth Beach, Del., one of the four. last year was the second-worst for beach closings We pride ourselves on keeping the beaches clean in its two decades of monitoring. and on our water quality.

Eco-group tracks near-record wave of closings, alerts in 2010

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By Anne R. Carey and Alejandro Gonzalez, USA TODAY

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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Official bus fatality count just doesnt add up

Agency relies on info from local authorities
By Alan Levin USA TODAY The sleepy driver of a motor coach carrying members of the First Baptist Church of Eldorado, Texas, on a sightseeing tour in fall 2003 weaved erratically for miles before swerving off the interstate and striking a parked semi-truck. The impact crushed the front of the bus and ripped loose seats. This crash in Tallulah, La., killed eight people and made national news. An investigation by the National Transportation Safety Board (NTSB), which monitors safety and investigates crashes, blamed the fatigued driver and raised broad safety concerns about inadequate federal oversight and poor seat design. But if lawmakers or the public searched for the deaths in that Oct. 13, 2003, crash in the official statistics of motor coach accidents presented by the National Highway Traffic Safety Administration (NHTSA), they would not find them. In its 2007 report, NHTSAs Approach to Motor Coach Safety, the agency said two occupants of motor coaches died in 2003. The agency, which is responsible for keeping track of accidents and fatalities, updated that number to three in testimony March 30 before the Senates Surface Transportation Subcommittee. A USA TODAY review of federal accident data, news reports and interviews with local law enforcement authorities discovered at least 14 accidents and 32 motor coach occupant deaths not included in NHTSAs official tally of motor coach crashes from 2003 to 2009. Bus safety advocate Brad Brown of Beaumont, Texas, whose daughter, Ashley, 16, was among the two members of a girls soccer team who died in a bus accident March 30, 2006, says he isnt surprised. The number of deaths he sees reported in news stories always seemed high compared with the official statistics. When I just think about the deaths that I know about and I look at the annual data that NHTSA reports, it just doesnt add up, Brown says.

Tally too low

The federal government has undercounted deaths of motor coach occupants in accidents, USA TODAY research has found. NHTSA reported deaths Additional deaths 00 3 01 3 02 03 3 04 05 06 8 1 07 08 09 9 2
Sources: National Highway Traffic Safety Administration, state and local law enforcement, USA TODAY research By Janet Loehrke, USA TODAY

20 13 23 33 4 19 2 38 10

Issues with data

When NHTSA calculates motor coach fatalities, it relies on the massive Fatality Analysis Reporting System, or FARS, which holds detailed records of every fatal crash in the country. The system contains no official definition for motor coach, so statisticians must rely on a crude approximation for these buses

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.

Twist of the knife

Jessica Weishair, 16, a high school sophomore from Pelican Rapids, Minn., was on her way home from a band trip to Chicago on April 5, 2008, when the schools rented motor coach went off the road and rolled. She was flung from the bus and crushed beneath it. Officials who coded the accident information listed the vehicle as a transit bus like those used to transport people in cities, although it was a motor coach manufactured by Van Hool. The accident was not included in NHTSAs motor coach statistics. As a result, the death was not among those cited in NHTSAs proposal last year to require seat belts on motor coaches. Weishairs father, Kim, has campaigned for improved bus safety since the accident. He says he thinks Jessica would have lived if her bus had been equipped with seat belts. When told his daughters crash hadnt been counted in motor coach accidents, he said he was stunned. It really takes that knife thats sticking out of your heart and twists it a little bit more, Weishair says. Its not going to bring her back, but I do want her counted in these statistics. Contributing: Luke Kerr-Dineen uDeaths undercounted, 1A

Need to balance protecting patients, legitimate research

Continued from 1A stem cells those derived from human embryos hold special appeal because they can give rise to every cell type in the human body. More recently, researchers have raised the possibility that induced stem cells created from skin cells may have the same potential. As a result, world-class scientists agree that stem cell therapies may someday help to rebuild failing hearts, restore cancer-ravaged tissues, bridge gaps in nerves or regenerate damaged lung tissue. We really could repair faulty or COVER damaged tissues, says George Daley, STORY director of stem cell transplantation at Childrens Hospital Boston, whose team infuses stem cells into leukemia patients as a component of bone marrow transplants. These transplants, which involve destroying cancerous bone marrow and replacing it with disease-free stem cells, have been the standard of care for leukemia for decades. Daley says bone marrow transplantation remains the only proven form of stem cell therapy. Virtually everything else is highly experimental, he says, including the most controversial stem cells of all, those derived from human embryos. It may seem that Colons treatment turned back Photos by Eliot J. Schechter for USA TODAY the clock, experts say, but theres no evidence that the infusion had anything to do with it. Useful in orthopedics practice: Joseph Purita treats patient Tim O'Brien with his own stem cells. He is We have no way of knowing even whether being treated for a torn rotator cuff. Purita only uses stem cells in his orthopedics practice. stem cells are the active ingredient, Daley says. Even Purita acknowleges that he cant be sure Colons improvement resulted from his therapy. Can I be 100% sure it was the stem cells? No, I cant be sure, Purita says. MLB is investigating to make sure Colon wasnt given any banned substances. Purita says he would never take that risk. He also says he limits his stem cell practice to his orthopedics speciality. Im not trying to treat Alzheimers and strokes. Yankees spokesman Jason Zillo says Colon declined to comment. Steenblock says he treats patients with heart disease, diabetes, stroke, seizures, Parkinsons disease, cerebral palsy, Lou Gehrigs disease (ALS), kidney failure and chronic lung disease. He refers some patients to a clinic in Mexico. Steenblocks record is anything but unblemished. California Osteopathic Medical Board records show that the board revoked Steenblocks license in 2009 for gross negligence, excessive prescribing and dishonesty while treating a stroke patient with hyperbaric oxygen, which is also controversial. The revocation was stayed; Steenblock may continue to practice medicine, but he was placed on five years probation, during which he was required to take a course in medical ethics. Steenblock acknowleged the judgement against him, but said his license is unfettered and hes appealing the ruling. Steven Nissen, chief of cardiology at the Cleveland Clinic, was so incensed when Jaber told him about his stem cell patient that he fired off a letter of complaint to the FDA. Jaber says he was interviewed by FDA investigators. The two Mayo Clinic patients told their doctors they had their blood drawn at the Regenocyte Therapeutic clinic in Bonita Springs, Fla., run by Zannos Grekos. Grekos says he sent the blood to Israel for processing. It was then shipped to a hospital in Santo Domingo, the Dominican Republic, where the cells were infused into the patients. Grekos also has had his problems with state regulators. On Feb. 23, the Florida Board of Medical Examiners filed an emergency order blocking Grekos from providing stem cell therapy in Florida. The state took action after Grekos infused bone marrow cells into the cerebral circulation of a 69-year-old woman suffering from a stroke. The woman, who got the infusion as an outpatient, fell at home that evening and later died of injuries from her fall, records show. A Florida prosecutor, Robert Milne, charged that the treatment was entirely experimental and had no substantiated medical and/or scientific value. Were going to request a hearing and present our side, Grekos says. He notes that while he cant do stem cell procedures in Florida, hes still doing the infusions in other places, including the Dominican Republic and Athens. Steenblock and Grekos reject the criticism of their efforts. Some (doctors) are more conservative, some are more progressive, Grekos says. If we didnt have more progressive physicians, medicine wouldnt move forward. Nevertheless, says Mayos Burger, This isnt an approved study or a therapy approved for use in the U.S. The challenge, he says, is to find a balance between protecting patients and allowing doctors enough latitude to innovate and carry out legitimate research. You dont want to slam the door on something that in 10 years may have potential for people with end-stage disease, Burger says.

Power of positive thinking

Ted Kaptchuk of Harvard Medical School says hes not surprised that some patients appear to benefit from stem cell treatments. Thats not necessarily because the treatments work, he says. What matters is that patients think they work. Kaptchuck says medical history is filled with studies in which sugar pills and sham surgery out-perform the real thing, a phenomenon called the placebo effect. The placebo effect is especially potent in surgery, he says, noting more than 100 studies in which people do wonderfully on the placebo. In one powerful example, he says, a researcher tracked patients for two years after half had real surgery and half had a sham procedure for arthritis of the knee. The patients who had fake surgery, Kaptchuck says, were hopping around, doing great. There was no difference between the sham surgery and the real surgery. He adds: When you go under the knife, its like going to a shaman. The only difference is that there are no feathers, there are machines and test tubes. An Internet search for stem cells will turn up a roster of doctors who offer purported stem cell treatments. Most use adult cells from the patients themselves. No one knows how safe or effective the procedures are, researchers say, because few, if any, of the doctors now offering them to patients have tested them scientifically. Its a case where the hype is ahead of the science, says Gary Green of UCLA, medical director of Major League Baseball. Even doctors working on FDA-approved stem cell clinical trials are still figuring out how to formulate treatments, deliver them effectively and achieve maximum potency. Reliable therapy is years away. When patients agree to undergo unapproved therapies, they are taking a leap of faith, based on little more than the word of their doctors and the encouragement of other patients. Wed all love easy miracles, says Larry Goldstein, head of stem cell research at the University of California-San Diego. Thats not the way it works. In most cases, stem cell doctors extract the cells directly from the patients blood, fatty tissue or bone marrow. They use standard laboratory methods to separate them from the blood or other substances. Doctors at some offshore clinics may also obtain stem cells from umbilical cord blood or, in rare cases, human embryos. Doctors then inject or infuse the slurry of concentrated cells back into the patient, where, both doctor and patient hope theyll promote healing. These approaches especially the use of human embryonic stem cells have not been approved by the

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.

Corrections & Clarifications

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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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