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Prescription drug abuse is at its worst and getting worse.  Yet the Food and Drug Administration has approved Zohydro, a painkiller with huge potential for abuse. To make matters worse, this drug is "crushable," meaning it can be ground to a powder and snorted to give a quick powerful rush to the illegal user. The FDA has required producers of some other painkillers to embed the active ingredient in a matrix that is not "crushable," but not so for Zohydro. Critics contend this new drug is unnecessary. "Attorneys general from 28 states have already asked the FDA to reconsider its approval. But in its statement, the agency said, the data shows the drug is safe, effective and needed." Read this scary transcript of an interview on National Public Radio:

 

 

http://www.npr.org/2014/02/26/...-approval-of-zohydro

I yam what I yam and that's all I yam--but it is enough!

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Originally Posted by Bestworking:

What's going on? Why is the left after the FDA?

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The "left" is not some monolithic, predictable entity that can be consistently relied upon to take positions that you or other issue taxonomists deem "leftist." In your small-minded simplistic world, you fail to accept that I or others who may take left-of-center positions on a given issue have no obligation to automatically line up in support of other issues that might lie on that side of the right-left divide.

I'm a lefty and I'll try to "go" after anybody or any organization that tries to put more opium based drugs in America.  People have been dealt enough misery with them already.  We don't need stronger, improved versions that pill doctors can push.  

They finally got oxycotin to be in a noncrushable form, now, something stronger and crushable is coming out.  That's real progress on the war on drugs

Originally Posted by Bestworking:

Thought you lefties didn't agree with the "war on drugs". No, there's some other reason they're going after the FDA. Just have to wait and see. Who's dealing all these people such misery? Oh, right, it's not their fault they're druggies, unless it's someone on the right like Rush.

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The "war on drugs" has to do with illegal drugs.  The topic of this string has to do with a legal, regulated drug, the FDA approval of which is being challenged. I realize that it is difficult for you, but you should at least make some effort rot to introduce irrelevancies into the discussion.  The drug company seeking favorable treatment from the FDA for this supercodone paid at  least one research contractor at a key FDA meeting $30,000 for his participation.

 

As to other reasons the critics of FDA are concerned, you seem not to have paid attention to the content of  the link in my initial post.  There is no need for you to await new and startling disclosures. Here are some pertinent excerpts I have selected for you, so that you will not have to apply your obviously limited attention span to the full article:

 

<<<FDA's own advisory panels seem to agree. The panel voted 11-to-2 not to approve the drug. Then in November, top FDA officials overruled that panel. And that's where things get complicated. Last fall, a series of emails were made public from a Freedom of Information Act request. They were emails between two professors who had, for a decade, organized private meetings between FDA officials and drug companies who make pain medicine. The drug companies pay the professors thousands of dollars to attend.

*             *                  *                   *      

And here's what has critics concerned. One of those companies was Zohydro's original manufacturer, Elan Corporation. Zogenix wasn't in the picture yet but went on to partner with Elan.

Dr. Kolodny of Phoenix House Foundation.

KOLODNY: When those emails surfaced, I think for many of us there was a sense of a-ha.

SULLIVAN: Elan has a new owner and the company did not respond to requests for comment.

In a statement, the FDA said the meetings did not address specific drugs and that the FDA took part to develop better research methods. The statement says those research methods may have benefitted companies making pain drugs but that they also benefitted patients.

Zohydro's Dr. Galer attended the meetings when he worked for another drug company.

GALER: Those actually were looking at old studies to improve patient care.

SULLIVAN: So I asked him: But if the drug manufacturers are sitting in a room with FDA officials talking about pain drugs, and they're there because they spent 20 to 30 thousand dollars to be in the room, and some of the other advocates aren't allowed in that room at the same time, does that raise any concerns for you that that could be a conflict of interest?>>>

 

More much-needed enlightenment for you: http://www.cbsnews.com/news/fd...ti-addiction-groups/

 

<<<One of the physicians asking the FDA to revoke its approval is Dr. Andrew Kolodny. He is the chief medical officer of Phoenix House, a clinic that treats patients for drug addiction. He said, "This is a product that's dangerous even to people who are trying to use it as directed.">>>

 

Now, Best, you can use these facts to nourish  your own "sense of a-ha" !

Originally Posted by direstraits:

Took on percoset from my dentist. After coming down, I switched to Advil, then aspirin. 

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A few years ago, I had surgery to repair a wrist fracture--steel plate and 6 titanium screws.  Hurt like the mischief the first day after and the doctor prescribed Hydrocodone. The prescription was for 50 tablets!  I took only one and needed no more; Ibuprofen was sufficient  for the next several days. Flushed the Hydrocodone.

 

Why would that doctor have prescribed 50 tablets of this potent painkiller? 

I don't think pot is that bad, cocaine is very addictive.  The percoset and hydrocodone are physically addictive.  After having dealt with a dopehead in my family, I would rather all opiate based pain relievers be given  in a hospital setting.  I was told at family counseling for people dealing with dopeheads that more people are killed by overdosing on pain pills than any thing.  I too took percostet to deal with broken ribs and a broken collar bone.  I had to quit taking them, the worst pain that I had was getting that crap out of my body.

Back in the early 70s I had a tooth pulled and it got what they called a "dry socket" , never had any pain anywhere near that bad before or since. Dentist gave me Percodan which is Oxycontin and aspirin . (back then there was no such thing as Tylenol or ibuprofen. I would wake up at 3 or 4 in the moring with my jaw feeling like it was three feet out from my face, would take two of those and swallow it with a double shot of whiskey. Didn't care if it killed me, as long as the pain stoopped.

Took over a month before that thing got completely under control, dentist kept giving me scripts for it, and finally it healed , but I wanted another pill. Really wanted another pill (I still had a bottle in the cabinet)  For two days, I lay on the couch in the living room in cold sweats, upset stomach, and a picture of one of those pills in my mind.
On the third day, I was over it all, and never took another Percodan. From time to time I have since taken Percoset (same drug except with Tylenol instead of aspirin) , and have not had any problems.

Said all that to say two things, 1 if what you are worried about is addiction, first thing to do is get rid of cigarettes - I personally know they are way more addictive than Opioid pain killers, 
2> if you don't want to be addicted to pain killers, you don't have to be , you can quit.

And by the way, control of pain killers really is part of the "war on drugs"  There was a time, before Nixon, when if you knew the druggist , you could walk in to the drigstore and get things like a few pain killers, or paregoric, or cough med (that actually stopped a cough) without a script. Nixon and his classifications changed all that. Then, GHW Bush, wrote an executive order that made it illegal for a terminally ill patient to receive enough pain medicine to be comfortable.

It seems to me, that this "war on drugs" is near and dear to the hearts of some of the people on the right.

 

Mad, you must be the smartest one posting on this topic,  I agree with you, I too have been personally affected by opium based pain pills.  Doctors really push strong pain pills on people, when the addiction takes hold, they answer-- they didn't take then like I told them to.  The fact is, when you are sitting in a doctors waiting room and the well dressed person with a briefcase walks in and is quickly shown in and is telling the Dr. what type pills to prescribe.  Then that doctor is going to prescribe that brand.  After all, that's where those perks are coming from.

Originally Posted by Contendah:
Originally Posted by direstraits:

Took on percoset from my dentist. After coming down, I switched to Advil, then aspirin. 

___

A few years ago, I had surgery to repair a wrist fracture--steel plate and 6 titanium screws.  Hurt like the mischief the first day after and the doctor prescribed Hydrocodone. The prescription was for 50 tablets!  I took only one and needed no more; Ibuprofen was sufficient  for the next several days. Flushed the Hydrocodone.

 

Why would that doctor have prescribed 50 tablets of this potent painkiller? 

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By the time my mom was in her late 80s and 90's her back was about gone, and sitting for any length of time was painful. However, every Thursday, she played bridge with her club, and she would take a percoset before she went to play, so she could sit and play cards for those 4 hours. Also, any time she was going to have to sit in a car, like to go to the Coast, she would pop one.

The doctor gave her fairly large scripts for it just to save both of them time.

She never got addicted.

Some people may need them to function, but I could not function when I was taking them.  I will say, like Seeweed, that after washing one down with a shot of whiskey I thought I was ten foot tall and bullet proof.  I would play with the grand kids, pick guitar and get out and walk.  Three hours later I would be hurting, and take another.  That is why I quit taking them before I ran out.  But dayum they were good with Jim Beam.

Originally Posted by jtdavis:

Mad, you must be the smartest one posting on this topic,  I agree with you, I too have been personally affected by opium based pain pills.  Doctors really push strong pain pills on people, when the addiction takes hold, they answer-- they didn't take then like I told them to.  The fact is, when you are sitting in a doctors waiting room and the well dressed person with a briefcase walks in and is quickly shown in and is telling the Dr. what type pills to prescribe.  Then that doctor is going to prescribe that brand.  After all, that's where those perks are coming from.

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And you'd be the??? You have this thing where you are always in a position to see all these things, like a well dressed person with a briefcase coming in and being quickly shown in to see the doctor, and you know immediately he's going in to tell the doctor what type of pills to prescribe. Sheesh.

Originally Posted by jtdavis:

Mad, you must be the smartest one posting on this topic,  I agree with you, I too have been personally affected by opium based pain pills.  Doctors really push strong pain pills on people, when the addiction takes hold, they answer-- they didn't take then like I told them to.  The fact is, when you are sitting in a doctors waiting room and the well dressed person with a briefcase walks in and is quickly shown in and is telling the Dr. what type pills to prescribe.  Then that doctor is going to prescribe that brand.  After all, that's where those perks are coming from.

I don't know why any sales person would "push" for the older Percosets, or Lortabs , they are dirt cheap.

 

Originally Posted by mad American:

They are dirt cheap to the person that has the 'script'.  They in turn can peddle them in bars for five to ten bucks apiece. 

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Again, why would a drug salesperson try to encourage a dr to "push" them ?  That salesman does not get commission on those sold illegally.

 

Margaret Hamburg

From Wikipedia, the free encyclopedia
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Margaret Hamburg
Margaret Hamburg official portrait.jpg
Commissioner of Food and Drugs
Incumbent
Assumed office
May 22, 2009
PresidentBarack Obama
Preceded byFrank Torti <small>(Acting)</small>
Personal details
Born(1955-07-12) July 12, 1955 (age 58)
Chicago, Illinois, U.S.
Political partyDemocratic Party
Spouse(s)Peter Fitzhugh Brown
Children2
Alma materHarvard University

Margaret Ann Hamburg (born July 12, 1955, Chicago, Illinois) is an American physician and medical/public health administrator. She currently serves as Commissioner of the U.S. Food and Drug Administration.

She was appointed the Board of Directors of Harry Schein Associates, the largest provider of healthcare products and services to office-based practitioners in the combined North American and European markets, on November 3rd, 2003 She served on the board from 2003 until she was confirmed as Commissioner of the U.S. Food and Drug Administration on May 18, 2009. She has served as Vice President for Biological Programs, Nuclear Threat Initiative, Assistant Secretary for Planning and Evaluation of U.S. Department of Health and Human Services, and as Commissioner of the New York City Department of Health and Mental Hygiene. She was nominated in March 2009 by President Barack Obama to become the Commissioner of the Food and Drug Administration,[1] and was sworn in on May 22, 2009.[2] She has received numerous awards, among them the National Consumers League's Trumpeter Award in 2011[3] and the National Research Center for Women and Families' 2011 Health Research Policy Hero Award.[4]

Margaret Hamburg is the daughter of Beatrix Hamburg and David A. Hamburg, both physicians. Her mother was the first African-American woman to attend Vassar College and to earn a degree from the Yale University School of Medicine (which had previously excluded black students). Her father, of Jewish descent, had a career in academic medicine and mental illness research, public policy, and philanthropic leadership. He was the president of the Carnegie Corporation of New York. She is married to artificial intelligence researcher Peter Fitzhugh Brown, with whom she has two children.[5]

Last edited by Bestworking

Best,

 

The FDA's new drug approval process involves more than just the Commissioner's approval. Note also that the Commissioner has authority to revoke an approval.  She is currently considering a request to revoke approval for Zohydro, which I believe she should do.

 

 

"Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER [Center for Drug Evaluation and Research] the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale." 

http://www.fda.gov/drugs/developmentapprovalprocess/

 

"The FDA Commissioner is ultimately responsible for overseeing the safety of prescription and over-the-counter medications manufactured, imported or sold in the United States. The Center for Drug Evaluation and Research tests the safety and effectiveness of medications that are proposed for sale, and makes recommendations for approval to the Commissioner or their designee. The Commissioner also has the authority to revoke the approval of any medications if new information shows that it is not safe for consumption."

Read more: http://www.ehow.com/info_84835...s.html#ixzz2ueE8OYa9

 

seeweed, acetaminophen has been around for a long time, but they didn't use to put it in oxycodone or hydrocodone. I was just talking to my GP and he doesn't think it really helps if there is no fever. Oxcontin is a type of oxycodone, usually sold in this area as Percodan. People need pain relief. It's simply many don't know how to use something and then stop when the pain goes away.

 

I was specifically talking about dental implants and the doc told me not to try it without something stronger than tramadol. So If I need more pain relief, I'll get it.

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