Combs Spouts Off

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Posts Tagged ‘fda’

CO lawmakers siding with terminally ill over FDA

Posted by Richard on March 25, 2014

Ryan Dunne is 9 years old and terminally ill. He has Duchenne Muscular Dystrophy, and it’s destroying all the muscles in his body. Soon, he won’t be able to walk. Eventually, he won’t be able to breathe.

Last year, Ryan and his family found hope. He took part in a 6-month clinical trial of a new drug, one of two that have shown great promise. Ryan’s parents told CBS4Denver’s investigative reporter Brian Maass that the drug worked wonders:

“When there was no hope, all of a sudden things were getting better,” said Ryan’s father, Chris.

“He walked further, had better stamina and energy and didn’t fall into bed saying, ‘I’m tired,’ “ said his mother. “And when he was pulled off of it he went downhill immediately. The drug is effective.”

The other drug markedly improved 100% of the kids who received it, and there were no side effects.

But the trial in which Ryan was enrolled is over. And there are years to go before the FDA eventually approves either of the drugs — if it ever does.

Thousands of boys suffer from the same debilitating, fatal disease, and the FDA has been asked to grant “accelerated approval” to the drugs that appear to be their life-savers. The FDA response? It says that it has an “evolving position on these drugs” and “has reached no conclusions.” In other words, don’t call us, we’ll call you.

In Colorado, Democrats and Republicans have joined forces in support of a bill (HB1281) that gives the terminally ill the right to use experimental or investigational drugs without FDA approval. The bill has all the safeguards you’d expect: no insurance coverage, no suing if things don’t work out, a doctor must sign off, and the drug maker must agree to provide the medicine. Today, HB1281 cleared its first hurdle when it passed out of committee on a 10-1 vote.

Opponents seem few and their arguments lame. On a recent newscast, I heard one lawmaker object that Colorado can’t enact a law that challenges the FDA’s authority — apparently not a fan of the growing 10th Amendment movement. Another worried that without FDA approval, a drug might not be safe. But to a terminally ill person, any side effect from a drug that seems to work is preferable to the “side effect” of waiting — death.

Similar “Right to Try” bills are under consideration in other states. If you’re in Colorado or one of those states, urge your state legislators to support such legislation. There is also an online petition urging the FDA to grant accelerated approval for one of the DMD drugs, eteplirsen. Please go to HelpRyanDunne.com for more information and to sign it.

UPDATE: The petition has surpassed the 100,000 signatures needed to get a response from the Obama administration. But 200,000 signatures might elicit a better response, so if you haven’t signed yet…

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Blogger threatened for writing about nutrition

Posted by Richard on May 1, 2012

After being hospitalized with diabetes,  Steve Cooksey adopted a low-carb, high-protein diet. Within 30 days his diabetes was under control without drugs, and in three months he lost 45 pounds. He decided to start blogging about his success. When the North Carolina Board of Dietetics and Nutrition (NCBDN) discovered what he was doing, they informed him that he was breaking the law by “providing nutritional counseling” without a license. His blog could be shut down and he could face fines and jail time.

What kind of “nutritional counseling” did Cooksey offer? Responding to someone concerned about a diabetic friend, Cooksey wrote, “Your friend must first and foremost obtain and maintain normal blood sugars.” The NCBDN informed him that this kind of “assessing and advising requires a license.” It was OK for him to list the foods he ate, but if he recommended them to others, the NCBDN declared, he was “providing diabetic counseling which requires a license.”

This isn’t an isolated incident, according to WorldNetDaily. In fact, the FDA has gone much further and wants to go further still:

The actions against Cooksey are part of a growing trend by government officials to crack down on any groups or persons that offer alternatives to traditional medical treatment.

In 2010, the FDA raided the offices of Daniel Chapter One, a Christian ministry that promotes a diet based on the bible chapter that is its namesake after a federal judge refused to allow the FTC to level a massive fine against the company.

“They came in screaming and hollering, ‘This is a raid, hands up.’ I saw a gun in my face,” said Jim Feijo, founder of the company.

“They patted Jim down and removed him from the office. They didn’t show me a warrant. They came in very aggressively, that was needless,” said Tricia Feijo, Jim’s wife and partner and a trained homeopath.

Under Obamacare, the FDA has determined that a person’s own body is considered a drug and subject to regulation.

The Centeno-Schultz clinic in Denver pioneered Regenexx, a treatment in which a patient’s stem cells are removed, cultivated for two weeks in a lab then re-injected back into the body. The procedure is used to treat patients with knee injuries, partial rotator cuff tears in the shoulder and lower back disc bulges.

In 2008, the FDA informed Dr. Christopher Centeno that it considered the stem cells to be a drug and subsequently stopped the clinic from cultivating patients’ stem cells.

The FDA has even suggested that bottled water when used to treat dehydration should be regulated as a drug. Under the organization’s “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration,” the agency said it should have the authority to regulate all vitamins, supplements, herbs and other natural substances, including water when used to “treat” dehydration.

Want to do something about outrageous nonsense like this? Life Extension Foundation’s Legislative Action Center is a good place to start.

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