There was segment on this on Stossel (Fox Business Channel) last night. It was about an experimental implant for a degenerative eye disease that has shown great promise in helping some bind people see.
The doctor who created the implant has already spent 7 years and $50 million conducting FDA trials which have demonstrated that the implant works. Now the FDA wants more – another $100 million and trials that will last another 3 years.
There are too few customers for the treatment to warrant spending another $100 million on trials. So, investors won't fund the effort. The doctor is going to stop pursuing it.
A potential patient, Stephen Lonegan, was on the show who has an eye disease that could be helped by the implant. He said he wants the treatment and will take whatever risk is involved. Some FDA bureaucrat said no. They said that their restrictions are for his own safety. Stephen said: "There's nothing safe about going blind. I don't want to be made safe by the FDA. I want it to be up to me to make the decision myself."
So this poor guy is going to go blind as a result of the decision of some mindless government bureaucrat following the rules of some impersonal, uncaring government bureaucracy.
In the meantime, all we heard from the Democrats at yesterday's so-called healthcare summit is how evil insurance companies are forcing little old ladies to do things like use their dead friend's false teeth (seriously, this was a topic of discussion).
Joseph de Maistre once said that "every nation has the government it deserves". Well, here it is...
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Friday, February 26, 2010
Thursday, February 25, 2010
McCain Trying To Regulate Nutritional Supplements Once Again
John McCain has introduced yet another bill to get the FDA to regulate nutritional supplements. The Federal Food, Drug and Cosmetic Act (21 U.S.C. 321) could deny Americans freedom of access and mandate a doctor’s prescription for many dietary supplements.
Nutritional supplements have been under attack for a couple of decades. Every few years there is a push to regulate them. Fortunately, those efforts have always failed in the past.
Suzanne Somers has been fighting FDA control of suppliments for some time. As she correctly points out, the FDA did an internal study of themselves a couple of years ago and basically came to the conclusion that they lack the scientific capability and competence to evaluate new drugs and medical devices. A big reason why prescription drugs are so costly in America is because the pharmaceutical companies are at the mercy of the incompetent FDA, who takes too long to conduct drug trials.
Mandating that the FDA regulate nutritional suppliments will drive up their cost, as it has for pharmaceuticals. It will also deny Americans the freedom to do what they think is best to keep themselves healthy.
Obviously, we do need an independent body to verify the safety of potentially dangerous prescription drugs and the claims made by their manufacturers. However, that doesn't mean that we need the government to do it.
Have you ever looked at a piece of equipment or a label on an electrical chord and seen the letters UL? Underwriters Laboratories is private company that certifies products for safety and compliance with standards. Manufacturers pay UL to certify their products so that both the manufacturers themselves and their customers know that the company has delivered a safe, quality, product that is compliant with the relevant standards. The range of things they certify is stunning -- appliances; building materials; chemicals; equipment related to the production and distribution of food, water, and energy; high tech equipment; medical devices; and more.
If a product UL certifies turns out to be unsafe, the consumer can seek redress from both the manufacturer and UL. So, UL has every incentive to ensure that the products they certify are safe. Can you sue the FDA for allowing a dangerous drug on the market? Not really.
We could apply the same type of model to pharmaceuticals. Yes, require pharmaceutical companies to get certification for their new drugs. But allow private companies like UL and others to compete to provide that certification. The certification companies would complete by keeping up with the science and latest testing techniques, which would streamline the certification process, speed time to market, and lower drug costs. In the end, we'd also be safer with competing private certification companies than we are with the incompetent bureaucrats in the FDA.
The answer to the the mess the FDA created is right in front of us, but once again, neither political party is willing to make any real changes to the system at all.
In the meantime, we all need to tell the politicans to keep their sticky fingers off of our vitamins.
Nutritional supplements have been under attack for a couple of decades. Every few years there is a push to regulate them. Fortunately, those efforts have always failed in the past.
Suzanne Somers has been fighting FDA control of suppliments for some time. As she correctly points out, the FDA did an internal study of themselves a couple of years ago and basically came to the conclusion that they lack the scientific capability and competence to evaluate new drugs and medical devices. A big reason why prescription drugs are so costly in America is because the pharmaceutical companies are at the mercy of the incompetent FDA, who takes too long to conduct drug trials.
Mandating that the FDA regulate nutritional suppliments will drive up their cost, as it has for pharmaceuticals. It will also deny Americans the freedom to do what they think is best to keep themselves healthy.
Obviously, we do need an independent body to verify the safety of potentially dangerous prescription drugs and the claims made by their manufacturers. However, that doesn't mean that we need the government to do it.
Have you ever looked at a piece of equipment or a label on an electrical chord and seen the letters UL? Underwriters Laboratories is private company that certifies products for safety and compliance with standards. Manufacturers pay UL to certify their products so that both the manufacturers themselves and their customers know that the company has delivered a safe, quality, product that is compliant with the relevant standards. The range of things they certify is stunning -- appliances; building materials; chemicals; equipment related to the production and distribution of food, water, and energy; high tech equipment; medical devices; and more.
If a product UL certifies turns out to be unsafe, the consumer can seek redress from both the manufacturer and UL. So, UL has every incentive to ensure that the products they certify are safe. Can you sue the FDA for allowing a dangerous drug on the market? Not really.
We could apply the same type of model to pharmaceuticals. Yes, require pharmaceutical companies to get certification for their new drugs. But allow private companies like UL and others to compete to provide that certification. The certification companies would complete by keeping up with the science and latest testing techniques, which would streamline the certification process, speed time to market, and lower drug costs. In the end, we'd also be safer with competing private certification companies than we are with the incompetent bureaucrats in the FDA.
The answer to the the mess the FDA created is right in front of us, but once again, neither political party is willing to make any real changes to the system at all.
In the meantime, we all need to tell the politicans to keep their sticky fingers off of our vitamins.
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