American Elephants

The FDA is More Interested in Statistics and Numbers than in Real-Life Evidence. by The Elephant's Child

The Food and Drug Administration has announced that:

The only over-the-counter asthma inhaler sold in the United States will no longer be available after December 31, 2011, as part of an international agreement to stop the use of substances that damage the environment.

Primatene Mist inhalers are being discontinued because they use chlorofluorocarbons (CFCs) as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.

CFCs harm the environment by decreasing the earth’s ozone layer. This layer of the atmosphere protects us from some of the sun’s harmful ultraviolet radiation, which can increase the risk of skin cancers and cataracts. The United States and most other countries have signed an international agreement to phase out CFCs and other ozone-depleting substances.

This is absurd. If removing the CFCs from refrigerants and spray cans had no effect on the so-called ozone hole {it’s not a hole, but an annual thinning) the CFCs from asthma  inhalers would be such a microscopic amount that it could not have an effect of any kind. Cheap and readily available is an important quality, as millions of homeowners stocking-up on incandescent lightbulbs are saying.  The “science” on which this decision is based is highly questionable, but that has never stopped a government agency. The humanitarians urging the Food and Drug Administration to withdraw Avastin for women with terminal breast cancer claim that there is no other choice.  The evidence, they say. shows that Avastin doesn’t work.  But the National Comprehensive Cancer Network is a consortium of 21 leading U.S. oncology programs that issues guidelines for practices on the basis of “sound, evaluative clinical information” according to its mission statement.From the Wall Street Journal”

Just last week, the NCCN’s breast cancer panel reaffirmed its position that Avastin is an appropriate therapeutic option” for some patients in combination with chemotherapy. The vote was 24 in favor with one abstention.  No members were opposed.

The NCCN has reviewed Avastin for breast cancer four times since adding it to the compendium in 2005.  Each time they reaffirmed its support.  Their panels include practicing oncologists from some of the most important cancer centers.  They understand the benefits that Avastin can provide to some (but not all) women in controlling their disease. The FDA favors those who rely on statistics and think in terms of controlled trials. Its conflict-of-interest rules are meant to exclude doctors who have experience treating specific cancers in the real world. For the FDA, being an expert physician fatally compromises one’s objectivity in ruling on a drug for breast cancer. Physicians also do not go along with Dr. Pazdur’s known political agenda to increase his agency’s approval power over cancer drugs. This process is the essence of ObamaCare. Big Government relies on statistics, and cold hard numbers, not real life experience with real people. That’s why ObamaCare has an Independent Pay Advisory Board to make decisions about what Medicare will pay for and what it won’t. Big Government people always claim that they are doing things for the poor, for the children, for the elderly, but that is just window dressing. They are uninterested in real-life evidence, and real-live people.

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