Fw: Draft OpEd piece on FDA sharing confidentially
Hello Deepak,
Rough draf is attached as a Word document, feel free to modify, edit, add, delete, rewrite, etc. (We should probably aim to tighten it to below 2,000 words from its present word count of 2,408)
If you approve, we can send the final version to our friend Dan Henninger, Deputy Editor at WSJ. The WSJ editorial on the FDA Duchenne drug denial was published on July 6, 2016, so we would still be timely, and the FDA final decision coming soon will make the news again.
Perhaps you would like to expand on Personalized Precision Medicine, with reference to Super Genes?
Would Rudi Tanzi be interested in joining as a co-author? Perhaps he has additional insights on Duchenne's as a neuromuscular disorder?
We have not heard back from Paul & Bess, so do not know their level of interest, or if they wish to be listed as co-authors.
We have not approached Dave Brenner or other signatories to our previous OpEd pieces, perhaps they would be interested, and if you believe that more voices add credibility, they can be invited?
Eric Topol may have an interest since he was instrumental in exposing Vioxx as a major cardiovascular risk agent, and having it withdrawn by the FDA.
Looking forward to your thoughts, comments, and suggestions.
Love,
Joe & Nancy
May I do a rewrite ?
Deepak Chopra
2013 Costa Del Mar Road
Carlsbad, CA 92009
Absolutely!
How do you feel about an 800 word Op ed , slightly less inflammatory
Also when you cite over 10,000 drugs without science documentation are you referring to over the counter
drugs
Can you summarize everything in a few bullet points ?
2013 Costa Del Mar Road
Carlsbad, CA 92009
The Chopra Foundation http://www.choprafoundation.org/ http://www.choprafoundation.org/
http://ecx.images-amazon.com/images/I/51ryZ4SaSrL._SL500_SS115_.jpg
http://www.amazon.com/Super-Genes-Astonishing-Optimum-Well-Being/dp/0804140138/deepakchcom07-20
http://www.amazon.com/Super-Genes-Astonishing-Optimum-Well-Being/dp/0804140138/deepakchcom07-20 Super Genes: Unlock the Astonishing Power of Your DNA for Optimum Health and Wellbeing http://www.amazon.com/Super-Genes-Astonishing-Optimum-Well-Being/dp/0804140138/deepakchcom07-20
Of course, brevity will enhance the Op-Ed piece. The first draft was written while I was 'under-meditated', and I should have taken an anti-inflammatory as well!
The FDA has studied and approved 1,453 drugs in its entire history.
Seventy percent of the US population takes at least one prescription drug each month. The number of deaths from prescription drugs in the US each year exceeds deaths from illegal drugs, as well as from automobile accidents. Over 4 billion prescriptions were written in the US last year by health care professionals.
The total number of prescription drugs on the marketplace in the US is unknown, unpublished, and not tracked by the FDA. The clearest database is from the National Library of Medicine which lists 88,212 prescription drug compounds on file in the US. There are over 300,000 over-the-counter (OTC) drug products marketed in the US. The number of nutraceutical products is unknown, but sales in the US are estimated to be approaching $200 billion dollars per year, while dietary supplements and vitamins sales exceed $27 billion per year. Probiotics are rapidly growing in popularity, and worldwide sales are expected to exceed $50 billion dollars per year by 2020.
Most physicians and the public are unaware that the vast majority of prescription drugs in the US marketplace have not been studied or approved by the FDA. They are legally marketed only because of a 1938 legislative loophole grandfathering the continuation of their marketing and sale to physicians and the public.
A significant number of the 440,000 deaths in US hospitals each year arise from medical errors due to pharmaceutical adverse reactions or interactions. The cost to society of adverse drug reactions in the US exceeds $136 billion per year.
In 2004 an FDA approved drug was withdrawn after five years on the marketplace, and only in retrospect was found to be responsible for an estimated 38,000 fatalities in the US alone. Ironically, thousands of unproven drugs continue to be legally marketed while an FDA committee denied approval for a novel potentially lifesaving drug for Duchenne Muscular dystrophy. The denial was because the small number of study subjects, as expected with a rare disease, did not reach statistical proof of safety even though no participants had an adverse reaction.
Comprehensive and conscientious post-marketing surveillance should be required for all products promoted and sold as therapeutic, including prescription, OTC, nutraceuticals, probiotics, etc. There should be an emphasis on precision genomic information to enhance safety by identifying sub-populations with optional benefits and higher risk of adverse events.
The cross referencing of poly-pharmacy risk of drug-drug interaction including over the counter (OTC), nutraceuticals, probiotics, etc., and other data end points subject to meta-analysis, while preserving individual privacy rights, will greatly enhance public health and safety.
Writing this up for WSJ now
2013 Costa Del Mar Road
Carlsbad, CA 92009
The Chopra Foundation http://www.choprafoundation.org/ http://www.choprafoundation.org/
http://ecx.images-amazon.com/images/I/51ryZ4SaSrL._SL500_SS115_.jpg
http://www.amazon.com/Super-Genes-Astonishing-Optimum-Well-Being/dp/0804140138/deepakchcom07-20
http://www.amazon.com/Super-Genes-Astonishing-Optimum-Well-Being/dp/0804140138/deepakchcom07-20 Super Genes: Unlock the Astonishing Power of Your DNA for Optimum Health and Wellbeing http://www.amazon.com/Super-Genes-Astonishing-Optimum-Well-Being/dp/0804140138/deepakchcom07-20