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DarthNinja

Children’s OxyContin Trial Underway

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Purdue Pharma LP, maker of the popular painkiller OxyContin, is conducting a trial to test the effects of the drug in children with the hopes of receiving an extension to their patent by the Food and Drug Administration.

The study, which has been ongoing since November 2010, is looking at how the drug is broken down, absorbed and tolerated overall by children compared with adult. The company is also looking at whether the drug relieves pain in children the same way it does in adults, but stressed they will not be released a grape-flavored version anytime soon.

"These trials are not intended to promote the use of OxyContin in pediatric patients but will provide clinical information about the product's pharmacokinetics, safety and to a lesser extent efficacy, in pediatric patients to clinicians who may be, or may consider, using the product in children with moderate to severe chronic pain," James Heins, senior director of public affairs for Purdue, told CBS News.

More than 154 patients are involved in the study, with more being recruited. The study specifically looks at children between the ages of six and 16 with "moderate to severe pain," including those with cancer, sickle-cell anemia or severe burns.

The study will conclude in August 2013, and if it is completed according to FDA standards, Purdue would be given a six-month extension on their drug patent, which prevents generic versions from being made.

"The generous incentives were made available to stimulate performance of studies necessary to provide useful information on drug use in children," Sandy Walsh, spokeswoman for the FDA, told CBS News.

Walsh also said the effects of these powerful drugs on kids are of importance, because children are rarely included in the studies. Not only are kids smaller, they metabolize drugs differently, which means the mechanism of action for a child may be different than that of an adult.

"One of FDA's top priorities is giving pediatricians and parents the same level of tested and researched information on drugs used to treat children that is required for drugs used to treat adults," Walsh stated. "This effort ensures children are not denied therapies because we do not know how to properly dose or use them. All of FDA's initiatives around pediatrics have aimed to get products that are used in children studied in children."

While there is always the concern of addiction from painkillers, Dr. Daniel Frattarelli, chair of the American Academy of Pediatrics' Committee on Drugs, told ABC News that understanding the effects on kids would lead to doctors making better decisions.

"Pain is a real thing, and it needs to be treated," he said. "I would be much more comfortable prescribing it [OxyContin] if I knew that well-done studies had been conducted and also that there was a way of minimizing addiction."

http://www.isciencet...al-underway.htm

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This drug is incredibly dangerous. My brother started smoking weed (gateway drug, regardless of what anyone says) and doing Oxy, partially because he's an idiot and couldn't say 'no' to his moron friends on several occasions. Then moved onto heroin and cocaine shortly after because those highs didn't satisfy him anymore, I guess.

But he's doing better now, sort of.

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On the one hand, I don't have high regard for big pharmaceutical companies using humans as guinea pigs in order to get richer.

On the other hand, I work with children who are often in excruciating, unrelievable pain that isn't helped with the current meds available. Anyone with a modicum of medical knowledge of drugs and pediatric patients is aware that children's bodies often breakdown drugs differently than their adult counterparts do, that their bodies will use these drugs differently than adult bodies do. It's difficult, when you're holding a 3 year old who is screaming in unrelievable agony, not to want to have better drugs that will take care of their pain and give them some relief. So if highly supervised drug trials are taking place, I am torn between wanting a better pain killing drug for my little ones and not wanting big pharmaceutical companies getting richer at the expense of little people.

It is a conundrum.

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Some may see this as a means to 'further research' and perhaps even 'help kids in pain', however; that of course is the spin since this drug is very dangerous for even adults. Essentially, they are running these clinical trials on children (a FDA incentive that allows patents to be extended) for the sole purpose of maintaining their exclusivity on the patent rights to produce the drug over other pharmaceutical companies. It generates almost $3 billion per year in sales.

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Well, apparently BB has a medical degree and thinks children are immune to the addictiveness of the drug. I'll simply disagree given that it's obvious this hooks full grown men quite easily.

In before a hasty and probably arrogant reply from you know who.

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This drug is incredibly dangerous. My brother started smoking weed (gateway drug, regardless of what anyone says) and doing Oxy, partially because he's an idiot and couldn't say 'no' to his moron friends on several occasions. Then moved onto heroin and cocaine shortly after because those highs didn't satisfy him anymore, I guess.

But he's doing better now, sort of.

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How do you think they treat childhood diseases such as cancer? They drip poison into the arms of children in an attempt to kill cancer cells. How did they originally test childhood cancer drugs after the lab rats? On children. There are hundreds of thousands of adults alive today because that happened. Adults who have gone on to live healthy and productive lives and make huge discoveries in the advancement of medical treatments. Do you honestly think that the drug trials going on now are giving children adult doses of oxycontin? As I stated earlier, it is a well-known fact in medical circles that children sometimes react differently to adult drugs, that their bodies break down and process certain drugs differently.

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As a matter of fact I do. Do you?

Is this &*@*ing arrogant enough for you?

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On the one hand, I don't have high regard for big pharmaceutical companies using humans as guinea pigs in order to get richer.

On the other hand, I work with children who are often in excruciating, unrelievable pain that isn't helped with the current meds available. Anyone with a modicum of medical knowledge of drugs and pediatric patients is aware that children's bodies often breakdown drugs differently than their adult counterparts do, that their bodies will use these drugs differently than adult bodies do. It's difficult, when you're holding a 3 year old who is screaming in unrelievable agony, not to want to have better drugs that will take care of their pain and give them some relief. So if highly supervised drug trials are taking place, I am torn between wanting a better pain killing drug for my little ones and not wanting big pharmaceutical companies getting richer at the expense of little people.

It is a conundrum.

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Oh please, get over yourself. I did not say your post was arrogant, a little reading comprehension goes a long way. But nice try.

Just remember, your words "Just because you speak with confidence doesn't mean you know what the hell you're talking about" works both ways.

Haven't shown hostility? Oh puhleeeze, tell us another one, why don't you? :rolleyes:

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It's not a conundrum. There are plenty less harmful painkillers out there, already clinically tested with minimal side effects.

You're going to get side effects with any drug whether the biological impact is great or small.

Oxy's side effects in adults (if taken in a pill form) still present to be one of the more dangerous and addictive painkillers on the market.

Canada has some serious laws and regulations against Oxy the U.S.A. has yet to employ.

This drug has bad written all over it.

This is what happens when pharmaceutical corporations are allowed to pour money into congress, the FDA, and politics in general.

The well being of the citizens is not being taken into account here. The drug is made popular because of it's street value more than anything. This is a multi-billion dollar business, where a VAST PERCENTAGE of Oxy sales are going to people who don't need it, and "step" on it, package it, and sell it on the streets.

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Yes, you did. That or you decided to bold that section of my post for the fun of it. You obviously thought I was being a smart ass and evidently I was not.

I haven't shown hostility. I simply disagreed based on what I know and personal experience and you're getting all angry. Definitely wouldn't be the first time you've got angry in this forum at someone for disagreeing with you.

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The hostility is patently obvious in your posts in response to me. I'm not the only one seeing it as my inbox will attest to. And previous history of your posts in response to me confirms it. Of course the snotty comment at the end of that post meant nothing, right? Pffft, and there's a piece of water front real estate in Arizona for sale, too.

Really, brush up on that reading comprehension. You are woefully lacking in it. I highlighted the portion of your post I WAS RESPONDING TO. Are you really this obtuse or working toward a degree in it?

Nice edit of your original post, by the way. Turn the trolling into a nice suggestion......too late.

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Given how you overreact to such minor things, it's easy to see how you would have taken what I said as a sarcastic remark. And I wouldn't call it 'snotty' or anything of the sort. And you're proving my point right now anyway. Again, I disagreed and you're upset about it. Clearly. I'm sure this board has an ignore feature, if you don't like what I say you're welcome to use it.

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Hi. Thank you for your reply.

I am not a doctor so I do not know. I do know giving drugs to kids is a dubious undertaking. I would seek an alternate unless the kid was in some horrible pain.

I cited cancer because my mother died of cancer and she was in very serious pain at the end and so the doctors eased her suffering with painkillers. I thought in that case it was justified.

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