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6A Daily News – Tuesday, March 13, 2012 Vitality & health MINNEAPOLIS (MCT) — Like many young men counting down the days until they can drive, David Hastings has March 15 circled in red: It's the day he takes his behind-the-wheel dri- ver's test. Is he confident he'll pass the test? "Yes, I am," he announced firm- ly. Hastings had to master more than the usual chal- lenges to get to this point. For one thing, he's 22, not 16. And he has autism. Traditional driver's education classes haven't worked well for him. But now that he's studying to be a graphic designer, he figures he needs a car for indepen- dence. He's determined that his form of autism, Asperger's, won't stop him from achieving either goal. "It's an integral step to his becoming indepen- dent," said his father, Tom Hastings, who agreed that David needed to get his driver's license. "Initially he wasn't interested in dri- ving. But he's gotten to the age where he realizes that in another year, he's going to graduate and, hopefully, get a job, and he needs to be able to get where he needs to go." Hastings is a graduate of Courage Center's dri- ving program. He tried taking a regular driver's ed course, but he strug- gled with it. "The guy couldn't tell me what I was doing wrong," he said. That news of a com- munication problem did- n't surprise Connie Shaf- fer, director of the Golden Valley, Minn., center's program, which deals with students facing a wide range of physical and developmental issues. People with learning dis- abilities often need a dif- ferent form of instruction, she said. "You can't just say, 'Go up to the corner and make a right turn,'" she said. People with autism "don't process information the same way. "You have to identify the steps and break them down: You tell them at what point to slow down, MCT photo David Hastings can't wait to take his driver's test and get his license, even though he has waited until he is 22. He has Asperger's, a form of autism, and traditional driver's education classes have not worked so he has gone through a special program to learn his driving skills. at what point to turn the wheel, at what point to turn the wheel back again and at what point to accel- erate again. It's a different form of task analysis." Larry Sjerven is execu- tive director of Twin Cities-based Adaptive Experts, a for-profit dri- ving program. Like Shaf- fer, he is both a certified occupational therapist and a state-licensed driving instructor. "I have to wear both hats," he said. "First, I'm a therapist. I have to figure out what I can do to mini- mize a student's disabili- ties. Once I've done that, I can relate to them as a dri- ving instructor." The decision on whether to let offspring get behind the wheel can be difficult for parents, even under the best cir- cumstances. Add the vari- able of a special-needs sit- uation, and it becomes exponentially harder, Shaffer said. The decision ultimately involves many factors, from problem- solving ability, dis- tractibility and decision- making to physical attrib- utes, including maturity level, coordination and reaction time. "We have to look at each person individually," she said. If there is one universal factor, it's that learning- disabled students typical- ly fare better if they're older than their counter- parts. "They tend to be delayed in the maturation process," she said. "They haven't participated in group social interactions as much. The person needs to be emotionally and cognitively ready" to drive. "If they're a little older, they've had more time to get life experi- ences." The first step in both the Courage Center and Adaptive Experts pro- grams is an assessment of the would-be drivers to make sure they have the wherewithal to maintain control of a vehicle. In addition to tests conduct- ed in an office, Courage Center puts the would-be drivers in a car — in its parking lot, not on a street — to see if they grasp the concept of driving. "I've had people drive straight for a telephone pole because they're watching a squirrel," Shaffer said. "We need to assess their ability to stay on task." About 80 percent of the youngsters who go through the assessment move on to lessons, but Shaffer said that number is skewed as a result of parents not bringing in children who lack the concentration needed to drive. "Most parents know" whether their child is a viable candidate for dri- ving, she said. "On occa- sion we have parents who don't want to see the dis- ability, but for the most part, it's a question of whether their child is ready or not." For Tom Hastings, having David get a license will mean that his son has taken another step toward self-sufficiency. "I don't consider myself old," the 64-year- old said, "but I do realize that I'm not going to be around forever." Instructor Steve Quinn is as confident as David is about his chances of pass- ing. "We've been working together since July," he said. "He's really open about taking suggestions. I'm optimistic, but if he doesn't make it, we'll just try again." A Retirement Community for the Active Senior Citizens Rent Special $500 OFF first month rent! ◆ Independent Living ◆ Private Apartments ◆ Three Nutritious Meals Daily ◆ 24 Hour Secure Environment ◆ House Keeping Services ◆ Warm & Friendly Staff ◆Recreational Programs ◆Scheduled Transportation ◆Private & Formal Dining Rooms EQUAL HOUSING OPPORTUNITY Now Accepting NEW Patients. No referral needed in most cases. ALLERGY Clinic with Diane Kinney, PA-C Kylie Carreras, LVN NOW OPEN! 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While there's nothing to indicate Cellulaze is anything but safe and effective, consumers should know an FDA go-ahead is not a guarantee. The agency conducts a risk-benefit analysis that allows an item to be marketed for particular indi- cations — sometimes requiring little or no testing. The most stringent review process for medical devices is pre-market approval (PMA), for high-risk Class 3 devices such as pacemakers, defibrillators and anything life-sustaining or life-threatening. Manufac- turers must submit scientific evidence from clinical tri- als demonstrating "reasonable assurance" of safety and effectiveness. Just 1 percent of devices go to market via PMA, and only these are considered FDA "approved." The vast majority of devices that undergo FDA review are moderate-risk Class 2 devices such as med- ication pumps and surgical lasers like Cellulaze, grant- ed FDA clearance through a controversial process called 510(k). (Low-risk Class 1 devices, like stetho- scopes and gauze, are exempt from review.) Products get 510(k) clearance if they're found to be "substantially equivalent" to a legally marketed device, meaning they have the same intended use and techno- logical characteristics — or, if not, that the differences don't raise serious concern. There's no requirement of clinical testing to deter- mine the safety and effectiveness of 510(k) submis- sions, though the FDA does ask for clinical data in about 10 percent of cases. For example, the FDA required laser manufacturer Cynosure to conduct a trial for Cellulaze, which uses a laser already on the market but was adding a new intended use for the short-term reduction in the appearance of cellulite. The three- month trial of 57 women, scored by blind evaluators judging photographs, found a reduction in the appear- ance of cellulite and minimal side effects, including mild discomfort, bruising, swelling and numbness. To be clear, there have been no concerns raised about Cellulaze, which is being used as an example here because, hey, cellulite reduction is exciting. Some consumer advocates worry that insufficient testing in the 510(k) system lets unsafe or ineffective products slip through. As the chain of "substantially equivalent" devices grows, the less likely it is the new ones bear any resemblance to the original, and usually there's been no evaluation of safety or effectiveness in between, said Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen, a non- profit consumer rights group. Devices later found faulty or even recalled aren't automatically removed from the list, Carome said, so new products could be cleared based on tainted prece- dents. A new House bill called the SOUND Devices Act (HR 3847) aims to close that loophole. The Institute of Medicine, a nonprofit under the National Academies that provides policy guidance, said in a report last year that the 510(k) process is unreliable and recommended it be scrapped. Meanwhile, the FDA is under pressure from medical device manufacturers and some members of Congress who say the review processes are too time-consuming and unpredictable, delaying U.S. citizens access to new technologies by two years compared with other coun- tries, according to the Advancing Medical Technology Association, which represents medical device manufac- turers. The FDA says review of 510(k) and PMA sub- missions takes 90 days and 180 days, respectively. AdvaMed puts the average at 146 days and 326 days. James W. 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