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Vermont Brothers Get Deadly Disease, But Only One Gets Healing Drug - Yahoo!
The Leclaire brothers were born with the same deadly disease -- Duchenne muscular dystrophy. Max, 10, is in a clinical trial for a new drug that has miraculously reversed some of his debilitating symptoms, but Austin, 13, has been turned away.
Austin watches from his wheelchair as his younger brother's strength continues to return. Max was able to climb a big sledding hill in his Saxtons River, Vt., backyard, but his older brother's muscles are so weak, he can barely feed himself.
The boys have the same gene mutation that the drug targets and will eventually kill them, but because Austin can no longer walk, he did not qualify for the trial.
"My brother says he's doing it for me, that he's trying really hard," Austin told ABCNews.com. "That's why he wanted to do it."
For the last 52 weeks, Max has been enrolled in a clinical trial with the drug eteplirsen, manufactured by Sarepta Therapeutics. Once a week, he receives intravenous infusions in a double blind study.
But after only 16 weeks, his parents suddenly realized he was on the drug and not a placebo. Not only was the progression of the disease slowing down, "he has even gained skills," said his mother, Jenn Mcnary, 32.
There is no cure for Duchenne muscular dystrophy. Until now, doctors can only use steroids, which just temporarily delay the inevitable loss of muscle strength.
"My husband noticed first at the airport," said Mcnary. "He said, 'I think he's on the drug and a high dose.' Max opened one of the McDonald's milk jugs with the sealed top. He never had that sort of grip strength."
For the last year, Max has flown to Nationwide Children's Hospital in Columbus, Ohio, for his IV treatment, but now, he goes to the Dartmouth Medical Center in nearby New Hampshire.
After seeing the success of the drug, the first of its kind, researchers put all 12 of the study subjects on that treatment.
According to Mcnary, the children on the highest dose of the drug have made a 68-meter gain in distance in six-minute walking tests.
But in the time that Max has improved, Austin has deteriorated and now can't even pick up a drinking glass, said his mother.
"He has lost his ability to unlock a door handle and leave the house and move from the bed to the wheelchair," said Mcnary. "And in the next six months, we expect more sleep apnea that will require a breathing machine."
Austin enjoys his computer, but he can no longer use his go-cart because he has lost the back strength to sit up. He is homeschooled by his mother because he gets too fatigued in a regular classroom.
So far, the Mcnarys' pleas to the drug company have fallen on deaf ears.
"I have been getting very vague answers," said Mcnary. "I keep getting the same answer. They tell me to be patient."
Dr. Edward M. Kaye, chief medical officer and senior vice president of Sarepta, wrote in an email to Mcnary that she shared with ABCNews.com that he is "sympathetic" to their case.
"This remains a priority for us to get the drug not only to Austin but to other children who may benefit from the therapy," he said in the email. "This is a challenging request since it involves complex regulatory, political, manufacturing, and fiscal issues that need to be addressed before a compassionate access program can be developed."
One Brother Gets Vital Drug, Second Brother Denied the Drug
A spokesman for Sarepta told ABCNews.com that the "path forward" for eteplirsen will depend on its discussions with the FDA later this year.
In a statement, the company said it "... understands the urgent need of boys with DMD and their families," but cannot publicly speak about patients in its clinical trials.
"We have aligned with the DMD community in the fight against this disease for many years, and we are committed to finding the most expeditious regulatory path forward to bring eteplirsen quickly and responsibly to all of the boys who may benefit from it," the statement said. "Our priority is to gather and analyze the safety and efficacy data from the ongoing Phase IIb study, which will form the basis of discussions with the FDA to determine the most appropriate path for eteplirsen."
Duchenne muscular dystrophy affects one in 3,500 male births, about 20,000 children in the United States and 300,000 worldwide, according to Cure Duchenne, one of three organizations that have funded the clinical trial.
The muscular disease strikes between the ages of 3 and 5 as boys progressively lose their ability to walk. Eventually, they are wheelchair bound, their upper body strength fails, and, like Austin, they eventually cannot raise their arms to feed themselves.
Later, their breathing is affected and they require tracheotomies and breathing assistance. Eventually, the heart and lungs fail.
The drug is not a cure, but shows promise, according to Cure Duchenne founder Debra Miller, who has a 15-year-old with the disease. It is the first to target specific mutations in the gene that makes dystrophin, the protein that helps strengthen muscle fibers.
"We want to do everything we can to get this drug for all the boys and we are working with Sarepta," she said. "My son is still walking, but I can definitely see the weakness and it's like a stab in the stomach. The worst part is that every year he can do less than the year before."
But with only 12 research subjects having access to the drug right now, "It's a good news, bad news story," she said.
"We lived our life thinking this was a hopeless disease, but we have a good feeling about this drug," said Miller. "We are very hopeful and very cautious."
Her son is not in the clinical trial because the drug does not target his specific genetic mutation. But, she said, this trial has given other families the "proof of principle" that this type of drug can work.
As for the Mcnarys' children, Austin was diagnosed at the age of 3, when Max was already 3 months old -- too late for genetic testing. When Mcnary wanted more children, she was found not to be a carrier. Rather, she had a spontaneous mutation in her eggs.
"This can happen in any family," said Mcnary, who has six children in all, the Leclaire boys, who are from a previous relationship, her husband's twins and two healthy children from their marriage together, aged 4 and 1.
In the last year, the family has been "torn emotionally," according to Mcnary.
"I am clearly happy for Max because he is doing so well and exceeding our expectations for this drug," said Mcnary. "But it's taking much longer than we ever thought for the drug company to at least grant access to his brother [Austin] who is sitting home watching his brother get treatment."
"For the longest time, I felt so scared, because in the beginning, we weren't allowed to say anything about the clinical trial," she said.
But now Mcnary her husband, Craig, who runs a Roto-Rooter franchise, have been talking to whomever will listen. For the past six months, they have been emailing Sarepta's executives.
"I am like a broken record," said Mcnary. "I congratulate the drug company who are now public and doing well. Their stocks are going up. We are not just looking out for Austin. We have a lot of friends in the (muscular dystrophy) community. People are losing their upper body strength just waiting for this. This is urgent right now."
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Gold-medal swimmer admits to cheating in 100 breaststroke | Fourth-Place Medal - Yahoo! Sports
South African gold medalist Cameron van der Burgh admitted to taking extra underwater kicks during his world-record performance in the 100-meter breaststroke at the Olympics, an illegal move that would have earned him a disqualification if judges had caught him.
Swimmers are allowed one underwater dolphin kick during their underwater breaststroke pullouts. Replays show van der Burgh took three on the start.
[ Photos: South African swimmer Cameron van der Burgh ]
He told the Sydney Morning Herald that he took extra kicks, but defends himself by insisting he's not the only one.
''If you're not doing it, you're falling behind," he said. "It's not obviously - shall we say - the moral thing to do, but I'm not willing to sacrifice my personal performance and four years of hard work for someone that is willing to do it and get away with it."
Allowing dolphin kicks during breaststroke is relatively new. The rules were changed, in part, because of four-time gold medalist Kosuke Kitajima, a Japanese breaststroke star who routinely added rogue kicks underwater. When swimmers push off a wall and tighten into a streamline, their legs can arch slightly and resemble a kick. Kitajima and others tried to make this natural movement into an advantage by adding some force behind it. It was illegal and the move angered rivals, like American Brendan Hansen. But the kick was tough to enforce, so FINA changed the rule to allow it.
But the old "give 'em an inch" rule came into play and now breaststrokers are trying to sneak in as many kicks as possible, hoping to do it without drawing the attention of officials.
[ Video: Did British cyclists cheat to win gold? ]
''It's got to the sort of point where if you're not doing it you're falling behind or you're giving yourself a disadvantage so everyone's pushing the rules and pushing the boundaries, so if you're not doing it, you're not trying hard enough," the South African said.
Van der Burgh can get away with the kicks because there is no underwater video review of swimming races. After testing the technology at a meet in 2010 to great success, FINA, the international swimming body, has yet to incorporate it in international meets.
After these comments and the potential uproar they'll create, expect that to change by next year's world championships.
In theory, van der Burgh shouldn't be in danger of losing his gold medal. Swimming doesn't have replay review and the time for appeal has long passed. But the IOC has shown a willingness to impart its own interpretation of fair play so far in London, banning badminton players for tanking matches and attempting to expel a runner who jogged during a race in order to rest for another. Nothing is off the table.
That knee-jerk reaction should be resisted. Throwing in an extra butterfly kick doesn't put van der Burgh on a level with blood dopers and steroid users. It's the equivalent of taking some extra steps in basketball or flopping in soccer: athletes trying to get away with as much as possible under the rules.
[ Photos: Notable Olympic drug offenders ]
His biggest crime was admitting the kicks. Who admits to cheating? What's the benefit? Deny, deny, deny, brother! It's easy:
Reporter: "We saw you took three kicks on your pullout. Did you?"
Van der burgh: "No, I only took one."
If you're morally loose enough to try to justify cheating by giving the "everybody else is doing it defense," lying to some journalist isn't going to be too difficult.
Related Olympics coverage on Yahoo! Sports:
More Olympics coverage on Yahoo! Sports:
• Michael Phelps' philosophy on dating
• Aly Raisman relies on surprising drink for nutrition
• Mystery solved: How synchronized swimmers stay in sync
via sports.yahoo.com
Monday, August 6, 2012
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About Reliv | Healthy Living at Any Age!
The Reliv Story
Founded on the Future
Like many Distributors that followed in their footsteps, Reliv Co-Founders Robert L. and Sandy Montgomery were not looking to start a business when Reliv came into their lives. Bob had already retired at the age of 38 after selling his life insurance company. Their plan was to raise Arabian horses on their new farm while they raised their children together.
The Montgomerys’ interest in nutritional products began when they experienced the passing of two of their parents within a short period of each other. Bob and Sandy decided they were going to do all they could to maintain their good health, which meant optimizing their nutritional intake. At a nutrition industry event, they met Dr. Theodore Kalogris.
A Classic Company Is Born
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The Montgomerys began experiencing health results of their own. But it wasn’t until Bob was diagnosed with a benign brain tumor that they really understood how special Dr. Ted’s formula was. “After I had the tumor removed, I was able to recover in a fraction of the time I was told to expect,” Bob says. “The doctors were amazed at how my body bounced back so quickly.”
“At that point we knew we simply had to share our discovery with the world,” Sandy adds. “So we gathered some of our closest friends, sat down at our kitchen table with yellow notepads and began to design the company that would become Reliv.”
Today’s Ground Floor Opportunity
Now over two decades since its founding, Reliv is a global company with more than 60,000 Distributors worldwide. And according to Bob and Sandy, that’s just the beginning. “Reliv is as much of a ground floor opportunity now as it was when we started the company,” Bob says. “Most people have yet to hear about Reliv, and everyone can benefit from our products and business opportunity. As much as we’ve grown over the years, we’re going to grow even more in the years ahead.”
“What amazes me is that people just discovering Reliv today are sitting around their kitchen tables planning a better future just like Bob and I did years ago,” Sandy notes. “And the best part is they have the same opportunity to achieve their dreams through Reliv and change countless live along the way.”
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My Reliv Story | Healthy Living at Any Age!
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