Thursday, July 21, 2011

How potentially ineffective drugs are fast-tracked for approval

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21 July 2011

UK Edition

Dear Reader,

Most people probably assume that, when a new drug hits the market, that drug is an improvement over what's already out there.

I mean, isn't that what doctors — and patients — want to know? Whether or not this new drug is the best choice?

Well, sure. But that doesn't mean Big Pharma really cares — especially when drugs are getting approval from the American Food and Drug Administration (FDA) anyway.

A study published in the Journal of the American Medical Association (JAMA) reveals that 51 per cent of the new drugs approved in the last decade had comparative effectiveness data available at the time of their FDA approval. So the FDA, for the past 10 years, has been approving drugs without knowing if these drugs actually improved upon what was already out there.

Researchers looked at approval packages that are publicly available in a database of FDA-approved drugs. They found that just about half of the drugs approved between 2000 and 2010 had comparative efficacy data available at the time of market authorization.

Once they excluded orphan products, which is the term for drugs that may be useful but are not considered commercially viable, they found that the drugs with available comparative effectiveness data increased to 70 per cent. An improvement, yes, but that's still walking the line between a C and a D — not too reassuring when we're talking about people's health.

The researchers also didn't look at how informative the comparative effectiveness data actually was — all that was required for their check was at least one head-to-head trial with an approved alternative.

So what's the result here? A market flooded with drugs that may or may not be better than anything else out there. How can we even begin to navigate that particular mine field?

We need to demand more from these pharmaceutical companies — and from the FDA. Why should a drug be approved if it hasn't been proven to be more effective than what's already out there? Especially if an attempt at finding out hasn't even been made? It's absolutely outrageous.

You may or may not know this, but the FDA has joined the Facebook craze. And they actually allow consumers to leave comments on their page. Why not take advantage of this feature? Everyone who visits the page will see your comments.

Right now it's covered with people expressing outrage at the FDA going after Amish farmers selling raw milk — but that's a whole different e-Tip.

Continues below...


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Stopping the swelling

Q: My husband has swelling of the optic nerve. He has lost some vision in his right eye and is to have a [visual evoked response] VER test next week. The neurologist thinks it may be due to inflammation. I was wondering if there is anything he could take to try to bring back his vision?

Dr. Jonathan V. Wright: By now, it's likely you've heard that swelling in the optic nerve is often a symptom of multiple sclerosis. I hope your husband doesn't have that problem! But whether he does or not, some of nature's most important types of anti-inflammatories are the omega-3 fatty acids, found particularly in fish oils. Omega-3 fatty acids include (but aren't limited to) DHA and EPA, and along with omega-6 fatty acids are part of the successful long-term treatment of multiple sclerosis.

Until any inflammation subsides, one tablespoonful of high DHA/EPA fish oil and 400 IU of mixed tocopherols twice daily are a very good start.

If your husband has multiple sclerosis, please make an appointment for him with a physician skilled and knowledgeable in nutritional and natural medicine. In addition to the Swank diet, there are many other natural treatments that help considerably more than patent medication.
Bear in mind we are not addressing anyone's personal situation and you should rely on this for informational purposes only. Please consult with your own doctor before acting on any recommendations contained herein.

Wishing you the best of health,

Andrew Miller
UK Editor
Nutrition and Healing

P.S. In the latest issue of Nutrition & Healing, Dr. Wright will tell you about the shocking link between osteoarthritis and type 2 diabetes! Plus you'll learn about the one herb you shouldn't go without when undergoing chemotherapy. Plus, Dr. Wright will also provide more information about his new book, which is a 'do-it-yourself' guide to natural medicine and optimal wellness.

All new members who sign up will receive important updates like these in addition to receiving Dr. Wright's 7 Volume Library of Natural Healing.

Click here for full details.

Sources:

"Many New Drugs Did Not Have Comparative Effectiveness Information Available at Time of FDA Approval," Newswise (newswise.com)

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