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June 10, 2011 — The second pharmaceutical company to use the US Food and Drug Administration's (FDA) 2006 Unapproved Drugs Initiative to bring an old drug in from the cold, eliminate competing suppliers, and dramatically raise the price has run into a firestorm from Capitol Hill.
In July 2009, Philadelphia-based URL Pharma Inc, was granted 3 years of marketing exclusivity for Colcrys (colchicine) for acute gout flares, and generic sales were forbidden by the FDA. This approval was made under the Waxman-Hatch Act, based in part on pharmacokinetic studies and randomized controlled trials that studied 185 patients with acute gout. Previously, colchicine has been widely used off label despite lack of formal FDA approval; use of colchicine or its precursors for gout dates back to at least 550 CE.
At the time of the URL Pharma approval, 21 companies were making oral colchicine, and the cost was as low as $0.04 per tablet. In September 2010, the FDA ordered a halt to marketing of unapproved single-ingredient oral colchicines. After obtaining marketing exclusivity, URL Pharma raised the price to $5 per tablet.
(Above excerpted from Medscape’s May 2011 newsletter)
Wait a minute here. There. I believe there are a few more parts to the problem.
Yes the drug companies are ripping off everyone who takes drugs. But another thing that’s happening is that people are often not as responsible for taking better care of themselves as they should be. How many people do you think are quite aware of the fact that they need to eat better, or eat less. We can’t simply blame the drug companies for the problem. They are opportunists, but so are bugs (bacteria and viruses) and their tactic is to overcome the weak.
The strongest shall survive. We have an inherent responsibility to take care of ourselves and optimize our health and therefore adapt more ideally to the challenges of life. Remember it’s the inside that’s adapting to the outside. If we don’t know how, we should try to learn.
I saw an ad in the paper today from a local clinic of general practitioners and every one of them was considerably overweight. These are the trusted authorities?
I know that in this culture learning can be hard, especially with so much misleading information. Even the experts are often limited by their own narrowness of the boundaries in which they live or practice by.
Notice both parts ‘by how they live, and by the boundaries they practice within’.
Even the experts are limited to the specialization of their fields. They are also very controlled by regulations. Many doctors are so frustrated because they can no longer practice by their knowledge and experience and what they know to be clinically right for the individual. The governmental agencies have regulated us out of common sense when it comes to health care.
And there are so many accepted healthy life style notions that simply don’t result in healthy people. The proof should be in the pudding, as they say.
We’ll talk about some of these in future articles.
What we all ought to be thinking about is how to start taking better care of ourselves and to trust fewer and fewer authorities. I don’t mean that we should not listen to them; we should get a number of opinions but from many different sources. If you ask two physicians most usually that’s not two opinions. That’s only one, stated differently. Look for hints of ‘consciousness’ in the knowledge and advice.
Consciousness is still the core of existence. In the most ancient traditions, all health and life decisions were based on three primary criteria.
First, the information had to be consistent with the scriptures. The reference here is the “Vedas” which are the most ancient of traditions of health and life. The Vedic texts are the foundation of all healing arts practiced in the world today.
The second was what the guru advised or prescribed. In today’s context it would be the guru involved in the process, i.e.: your doctor, adviser etc.
The third, and what I think is the missing link, is what the individual feels in his or her heart of hearts. Not in a physical sense but metaphorically. It is best understood as a knowingness deep within.
At any given moment in any situation there are infinite number of choices available to us. The problem is that there is only one “right” choice and a feeling of comfort or discomfort in our intuition. This feeling is sensed in the area of our body in the region of the heart. It is not located in the mind. That is the seat of the ego, where judgment and analysis takes place.
So, if you’re upset with the high costs of medications, make better choices to take better responsibility for your health. Take small steps. Try to make them somewhat permanent until you are clear that another choice could be better.
Read a little about Ayurvedic medicine. Much information is available on the Internet. Look for conscious practitioners. Take some time regularly to learn more about health. Whatever your driving force in life is, you can’t do it very well without health.
Incidentally, I wouldn’t consider the FDA a trusted authority. My personal belief is that they sleep with the pharmaceutical folks. Even a cursory look makes this a bit obvious.
Yours in health,
Doc B
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