When will the U.S. Senate Investigate the FDA Ties to Pharma?
English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)
Marianne Skolek
Salem-News.com
July 10, 2012
(MYRTLE BEACH, SC) – This article is dedicated to “Michael David” — every parent’s child — a beautiful young man, loved by many whose life was cut short before his dreams were realized. Fly with the angels, Michael you are very loved and wonderful memories will always be in the hearts of your mom and dad, family, friends and those who never even met you.
The FDA never disappoints me. The big news this week coming from the FDA is that they are “cracking down” on pharmaceutical companies manufacturing and distributing “unapproved” drugs that contain Oxycodone — also known as OxyContin in time release formula. In a statement by the FDA, they cite these “unapproved” drugs containing the highly addictive ingredient in OxyContin had not been evaluated by the FDA for safety, effectiveness, manufacturing quality or appropriate labeling — and cannot be legally marketed in the U.S. The FDA gave the “drug pushers” of these unapproved opioids 45 days to stop manufacturing the drugs.
An FDA spokesperson was quoted as saying “We’re trying our best not to point fingers” when asked for the names of the pharmaceutical companies pushing these dangerous, unauthorized versions of OxyContin.
“It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.”
In 2006, under the Unapproved Drugs Initiative, the FDA sought removal of these “unauthorized” drugs. Do you question what took the FDA so long to initiate this action? I sure do.
The FDA never disappoints me in their protection of big pharma. They don’t seem to be concerned with the epidemic of prescription drugs in this country killing and addicting every day in the thousands. I’d like to point some fingers. Here’s an email I received the other night from the FDA. I guess they wanted to impress me with their diligence at protecting the American people — I wasn’t impressed.
“
Hi Marianne,
I hope you had a wonderful Independence Day! FDA just issued a press release, in conjunction with a Federal Register notice, about action CDER is taking against unapproved oxycodone products as part of its Unapproved Drugs Initiative. You can find the press release and links to further information here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310641.htm. I thought you would be interested in this action and potentially sharing it within the activist community.
Best,
James
–
James E. Valentine, MHS
Program Analyst
Office of Special Health Issues
Office of the Commissioner
U.S. Food and Drug Administration
White Oak Bldg. 32 Rm. 5363
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-8458
301-847-8623 (fax)
james.valentine@fda.hhs.gov
”
I replied to this email — “Too little, too late.” I will continue to expose the FDA for their incompetence and lack of concern for the prescription drug deaths and addictions in this country.
And no I did not have an enjoyable Independence Day as mentioned in the FDA email to me. I had been on the phone with a dad who lost his 18 year old son the year before because his physician over-prescribed opioids to the boy — even after the dad begged the physician to take his son off the dangerous narcotics. The boy had told his dad that he was becoming addicted. The reply the dad received from the doc was “your son needs them.” He needed them so badly that he committed suicide and died in his dad’s arms.
So call me cynical, but I am about finished with the FDA. For them to suggest that I share with the activist community their “too little, too late” action to protect the American consumer is an insult to the tens of thousands of families dealing with the loss of loved ones to death and addiction.
Last year I broke a story that the maker of OxyContin, Purdue Pharma was soliciting children ages 6 to 16 for clinical trials in the use of OxyContin. Links to my articles are provided below. My worst nightmare was realized this week when all major news media broke that Purdue Pharma had 150 children to ingest their highly addictive and lethal drug, OxyContin in clinical trials. It is being reported that by no means does it mean that the FDA will approve the use of OxyContin in children, it is to extend the patent of OxyContin for Purdue Pharm — which will result in billions of dollars to them.
If you believe that OxyContin clinical trials for children is about patent extension, then I have a bridge to sell you.
How much more do families suffering horrific loss due to this prescription drug epidemic need to endure while the FDA plays “pick the pocket” of pharma?
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- When will the U.S. Senate Investigate the Federal Drug Administration (FDA) Ties to Pharma? (salem-news.com)
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- Report: Purdue Pharma Testing Effects of OxyContin on Kids in Effort to Extend Patent by Six Months [Think Of The Children] (gawker.com)
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Filed under: news Tagged: | Center for Drug Evaluation and Research, FDA, Federal Register, Food and Drug Administration, Oxycodone, OxyContin, Purdue Pharma, Time release technology, When will the U.S. Senate Investigate the FDA Ties to Pharma?
The fda is big phrrma.150.000 people die from perscribed drugs approved by fda puppets. every year .why are so many drugs being recalled?with deadly side effects and side effects worse than death. Look who runs this corupt institution.It is filled wilh people who worked for monsanto and when there done at fda thay go back to monsanto to high paying seats after defraweding the americian people .indeed poisining us with gmos and all sorts of dangerious drugs that are killing our loved ones our children parents and grand parents.this country has been taken over by criminals and we have the wolf guarding the hen house
People have been self medicating forever, and we now have to go to a primary care physician who reads out of a PDR to give us an RX for things we used to be able to get OTC!! : (
Seems to me too many folks are too worried about people getting relief from pain via opioids. I see many many people suffering pain. They have very little choice. Either take anti-inflamatory drugs steroid and non steroid or opioids. or expose themselves to a huge medical industrial complex known as pain clinics, They slice you and dice you promising to relieve your pain, only to leave you mamed and hurting. Americans for the most part are educated enough to read a PDR and figure out what medication they need without going paying a primary care physician to read the PDR for us. The whole Pharaceutical business and ADA is bogus. We Americans should be free to name out own poison. Our air, water, and food are contaminated beyond repair. We have fluoride in our drinking water, put there by the powers that B. If all these drugs were available there would not be such a black market and our prisons would be virtually empty. Violent crimes would deminish because no one would have to deal with criminals. We have a huge crisis going on now in that our atmosphere is being filled with radioactive particals daily, due to Fukushima and no one is watching. Leave people alone to doctor their own ills, life will soon not be worth living and suffering will be widespread. If everyone would quit judging everyone else based on their own perceived righteousness we would all be better off. Most of the drugs marketed by Big Pharma especially the mental drugs are nothing more than modern day “snake oil”, approved by the same ADA whose board members mostly all have ties to Big Pharma. Give us adult Americans credit for having some common sense, and most of us know how to read. I dare say we all know better than anyone how badly we hurt and what helps and what doesn’t.