Opinion: The Deadly Gap in the Drug Safety Net
"Each day, about two out of every 100 prescriptions filled at pharmacies around the country are for drugs that have never -- repeat, never -- been approved by the Food and Drug Administration.
These unapproved drugs often make unsubstantiated claims not supported by scientific data or laboratory testing. Many of them are wrongly deemed safe and are often incorrectly labeled as "generics." None of them has ever seen the light of an FDA laboratory.
As a result, patients often end up taking drugs unaware that by doing so they are putting themselves at risk of a dangerous side-effect or potentially life-threatening adverse drug interaction."
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4 comments:
To my mind, this article is of a piece with
F.D.A. Says Millions Got Unapproved Heart Pills from the New York Times of March 26 in which we are instructed to be afraid of non-FDA approved nitroglycerin tablets. I would have expected nitroglycerin to have been grandfathered but we find the answer in the body of the article, to wit:
"The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the F.D.A. in 1927. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.
Many makers of various drugs, not only nitroglycerin tablets, have long contended that their medications did not require F.D.A. review because they were grandfathered as pre-1938 drugs. (The F.D.A.'s powers to require new drugs to demonstrate safety before being marketed came in 1938 with passage of the Food, Drug and Cosmetic Act.) But the agency is now disputing that interpretation of its rules."
In other words, big Pharma is simply using the FDA to limit its competition. As usual. It is prohibitively expensive to conduct bioequivalence and/or safety & effectiveness studies, which is how Pharma sought to limit the competition when they originally lobbied congress to pass the law back in the 80s. We have seen, since then, that Pharma's studies are often not worth the paper they're printed on as an estimated 80,000 people have to die before the FDA bans vioxx™ (as only one example in this sorry field).
Of the drugs mentioned by Dr. Gary Puckrein "oxycodone, thyroid medication, ephedrine, codeine, acetaminophen, hydrocodone, colchicine, nitroglycerin and morphine" Colchicine, derived from the autumn crocus and used to treat gout, has been used for millenia; codeine & morphine have been in use for more than a century; nitroglycerin is a homeopathic remedy ; natural thyroid preparations have been on Pharma's hit list for decades.
The recent Johnson & Johnson debacle should indicate to even the most inattentive that the FDA pursues only the small fish; the least toxic; least invasive; least expensive while leaving consumers with fewer choices among the more toxic/invasive.
I view these two articles as simply the run-up to the recent senate vote to maintain big pharma’s monopoly by blocking competitive imports
The FDA has been corrupt almost from birth (please read Dr Wiley's memoir below) but in recent years has gotten so bad even the insiders are alarmed (second and third links below)
THE HISTORY OF A CRIME
AGAINST THE FOOD LAW
Taking back the FDA
FDA Scientists Ask Obama to Restructure Drug Agency
To my mind, this article is of a piece with
F.D.A. Says Millions Got Unapproved Heart Pills from the New York Times of March 26 in which we are instructed to be afraid of non-FDA approved nitroglycerin tablets. I would have expected nitroglycerin to have been grandfathered but we find the answer in the body of the article, to wit:
"The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the F.D.A. in 1927. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.
Many makers of various drugs, not only nitroglycerin tablets, have long contended that their medications did not require F.D.A. review because they were grandfathered as pre-1938 drugs. (The F.D.A.'s powers to require new drugs to demonstrate safety before being marketed came in 1938 with passage of the Food, Drug and Cosmetic Act.) But the agency is now disputing that interpretation of its rules."
In other words, big Pharma is simply using the FDA to limit its competition. As usual. It is prohibitively expensive to conduct bioequivalence and/or safety & effectiveness studies, which is how Pharma sought to limit the competition when they originally lobbied congress to pass the law back in the 80s. We have seen, since then, that Pharma's studies are often not worth the paper they're printed on as an estimated 80,000 people have to die before the FDA bans vioxx™ (as only one example in this sorry field).
Of the drugs mentioned by Dr. Gary Puckrein "oxycodone, thyroid medication, ephedrine, codeine, acetaminophen, hydrocodone, colchicine, nitroglycerin and morphine" Colchicine, derived from the autumn crocus and used to treat gout, has been used for millenia; codeine & morphine have been in use for more than a century; nitroglycerin is a homeopathic remedy ; natural thyroid preparations have been on Pharma's hit list for decades.
The recent Johnson & Johnson debacle should indicate to even the most inattentive that the FDA pursues only the small fish; the least toxic; least invasive; least expensive while leaving consumers with fewer choices among the more toxic/invasive.
I view these two articles as simply the run-up to the recent senate vote to maintain big pharma’s monopoly by blocking competitive imports
The FDA has been corrupt almost from birth (please read Dr Wiley's memoir below) but in recent years has gotten so bad even the insiders are alarmed (second and third links below)
THE HISTORY OF A CRIME AGAINST THE FOOD LAW
Taking back the FDA
FDA Scientists Ask Obama to Restructure Drug Agency
tai
Thank you for this good comment. I posted the article for the very reason you responded, and I thank you, hY
It should be noted that when it comes to the attack on vitamins, Pfizer's OTC junque vitamins get Medicare approval but no other brand.
Call this price-fixing, limit to competition, conflict of interest or about any other corrupt practice...
Links for above comment
http://www.nytimes.com/2010/03/27/business/27nitro.html?scp=1&sq=nitroglycerine&st=cse
http://circ.ahajournals.org/cgi/reprint/73/1/21?eaf
http://zikkir.com/health/120489
http://www.soilandhealth.org/03sov/0303critic/030305wylie/030305toc.html
http://www.boston.com/yourlife/health/diseases/articles/2007/02/26/taking_back_the_fda/
http://www.boston.com/yourlife/health/diseases/articles/2007/02/26/taking_back_the_fda/
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