Political Lobbying Drove FDA Process
The FDA has recently approved a rubbery substance that can be inserted in the knee, acting as a cushion to repair torn menisci. In this report from the Wall Street Journal, ReGen, the company with the patent and manufacturing the product, insisted that the physicians that had been responsible for the 2006 and 2007 denials of the product not be placed on the committee in the 2009 process. This device was placed on the fast-track, which means that it is similar enough to another device that it does not need the expensive and time-consuming trials of a new device. The final committee members were only given a few days (instead of a few weeks, which is typical) to evaluate the pages and pages of data before a decision was made. It was unanimous in the affirmative.
My comments: Another example of the need for major overhaul of the FDA. It is scary when the company applying for approval can influence the track the approval process is given, and remove dissenting voters, and insist on a decision with inadequate time for proper review with the chosen group. This puts greater responsibility on the post-approval feedback, which is often sketchy and incomplete. New information on a product or drug tends to be more difficult to disseminate than training people properly on the product in the first place. This does not inspire confidence in the medical system, but does provide impetus to find alternatives to drugs and surgery.
My doctor says I can get all the vitamins and minerals I need from my food. What is your opinion on this?
I used to say the same thing to my patients, back in the days before I studied healthy alternatives. It is the party line of allopathic medicine, although that is starting to change. Here's the bottom line, and I'll follow up with some info on what allopaths are now doing:
2 responses so far ↓
1 Yolanda // May 14, 2009 at 5:52 am
In the email you mentioned that even with bone on bone, knee replacement might not be necessary. Can you explain that for us please?
2 Dr. Stan Gardner // Jun 9, 2009 at 1:46 pm
Yolanda, Bone-on-bone is an X-ray diagnosis, based on having little to no space seen between the bones. I’m not sure if there are different angles the picture is taken, or there is indeed cushion or cartilage between the bones, or … All I know is that when we use our techniques of removing pro-inflammatory triggers, using natural anti-inflammatory substances (including glucosamine), energy work (Jin Shin Jyutsu, acupuncture, frequency generators), tight muscle release, many of them get better and never get surgery.
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