[RedImmik]

Lured by Patent Protection, OxyContin Maker Tests Pain Drug in Kids



The powerful painkiller, OxyContin, seen at a Walgreens drugstore in Brookline, MA is now being tested to see how the drug works in children by Purdue Pharma. (Darren McCollester/Getty Images)


By CARRIE GANN (@carrie_gann) , ABC News Medical Unit
July 3, 2012


The maker of the powerful pain drug OxyContin is beginning to test the medicine in children, hoping to secure an extra six months of protection for the drug's patent, which is set to expire in 2013.
The move is controversial, in light of problems with addiction to OxyContin, which belongs to the family of drugs called opioids that also includes morphine and heroin. But several pain specialists say the move is an important step in giving a more accurate picture of the drug's effect on children, considering that many doctors already prescribe the drug off-label for children.
OxyContin's manufacturer, Purdue Pharma, emphasized that the company is not trying to make a kid's version of the drug, nor is it hoping to seek the U.S. Food and Drug Administration's approval for pediatric use of OxyContin. The goal, said company spokesman James Heins, is to give more information on how the drug acts in the bodies of children who may need it for the overwhelming pain of conditions such as cancer, sickle cell anemia, severe burns and other trauma.
"Doctors are already prescribing it in limited cases for kids, but they don't have the benefit of any clinical studies showing how these drugs work in kids. Right now, all they have to go on is data from adult patients," Heins said.




The trials are already underway across the country, and Purdue hopes to enroll 154 children from ages 6 to 16 who would take the drug for four weeks. When the trial is complete, the company will send the results to the FDA. Whatever the outcomes of the study, Purdue will get an extra six months of patent protection for their trouble.
OxyContin earned Purdue $2.8 billion in 2011.


The trial may seem to be centered in financial gain, and experts said the company is likely moved in large part by financial incentives. But Dr. Joseph Tobin, professor and chair of anesthesiology at Wake Forest University School of Medicine, said if drug companies are not given financial incentives to test drugs in pediatric populations, the studies would not get done at all.
"Children have become therapeutic orphans in the development or testing of new drugs. The expense and the risk are high, but the profit margin to be obtained is small compared with other diseases," Tobin said. "I think it's essential that this type of process goes forward so we can get better information on the safest uses of drugs in children."
In 2002, the government attempted to give drug companies incentives to test their medicines in kids with the Better Pharmaceuticals for Children Act, a law that allows an additional six months of patent protection for on-patent drugs. The patent that would be extended for Purdue would be the one covering OxyContin's formulation, which was modified in 2010 to make it harder for people to misuse and abuse the drug.
One of the drug's patents that will expire in 2013 is the one covering OxyContin's controlled release mechanism, which allows one pill to steadily dole out the medication over an extended period of time.
That mechanism is also what makes OxyContin different from other pain drugs, such as morphine and meperidine, or Demerol. It makes the drug more effective at treating pain, but it also makes it a highly attractive target for people addicted to opioids.
"The reason OxyContin has been such a social problem is that it locks up a large amount of drug in a small pill," said Dr. Elliot Krane, director of the pediatric pain management program at Lucile Packard Children's Hospital at Stanford University.



Health officials have become increasingly concerned about rapidly rising rates of painkiller addiction in the U.S. In 2010, a study funded by the National Institute of Drug Abuse found that 2.1 percent of 8th graders, 4.6 percent of 10th graders, and 5.1 percent of 12th graders had abused OxyContin for nonmedical purposes. The U.S. Centers for Disease Control and Prevention reported in 2011 that 40 people die per day from overdoses of painkiller medications like OxyContin.
Giving such a highly addictive and abused drug to children is controversial to be sure, and doctors say it will mean that prescribers must be particularly vigilant in watching how the drug affects young patients and to guard against pills being diverted to others to fuel addiction.
Krane, who is participating in Purdue's OxyContin trial and was a paid consultant for the company until last year, said the potential for children to become addicted to the drug is no greater or less than it is with other opioids that doctors give to children, such as morphine.
"Mere exposure will not turn them into an addict," Krane said.
Dr. Daniel Frattarelli, chair of the American Academy of Pediatrics' Committee on Drugs, said doctors face the challenge of balancing concerns about addiction with the need to treat pain in children. But he said if OxyContin is going to be used in children, it must be studied in children.
"Pain is a real thing, and it needs to be treated," Frattarelli 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://abcnews.go.com/Health/powerfu...ry?id=16706074

[outsitWrord]

Wtf?

[pavilionnotebook]

Just to get a extra 6 fricken months......

Fry a kids brain for life so you can bag 180 days of extra profit.

Surreal

[RedImmik]

Twister, it is sick !! I can't keep up with the Big Pharma news....there's so much daily that it's mind-boggling, really.
It's like these evil science experiments and the people are still lining up for drugs or letting their kids have drugs like a PIG TO THE SLAUGHTER !!!!!

[amusaasyday]

So we're all clear, that is basically pharma grade heroin.

[jdynwa]

The people that treat children as testing grounds should be wiped off the earth basically .

[Anypeny]

So will they come in chewable form maybe in the shape of some fun disney characters?

[grofvuri]

This is so disturbing! They know that it's as addictive as heroin. I can't believe that they're doing this just for an extra six months of patent protection. (I can, but it's just sick.) As if they haven't made enough money peddling this drug. Consider that this drug is not only used by people who have pain, but also as a street drug. That must be the holy grail of the pharma industry.

They insist that they're not trying to make a child's version of the drug . . . but if it passes the FDA approval, won't that be their next greedy step?

[we0MA4MI]

Next step?

How about breakfast cereal?

Or not being required by the FDA to list it as an ingredient in food?

As obscene as Big Pharma has become, just take a stroll through any grocery store where more and more
of the stuff sold as food is made of wood pulp and synthetic chemicals.

[erelvenewmeva]

Dont forget to tech your children:

Street Drugs = BAD

Corporate Drugs = Wholesome and delicious

[namaikaimvputka]

And the Medical/Industrial complex continues on. Who gives a crap about the people, we don't want to get in the way of profits.

[jdynwa]

1,513




(NaturalNews) British registered company, GlaxoSmithKline, faces $3 billion in penalties after pleading guilty to the biggest health care fraud case in history. GSK admitted that physicians had been bribed to push potentially dangerous drugs in exchange for Madonna tickets, Hawaiian holidays, cash and lucrative speaking tours. They also admitted distributing misleading information regarding the antidepressant Paxil. The report claimed that it was suitable for children, but failed to acknowledge data from studies proving its ineffectiveness in children and adolescents.

GSK faced charges that they had used the gifts to sell three drugs that were either unsafe, or used for purposes that were not approved. The first drug, Paxil also known as Seroxat, was touted as safe and effective for children and adolescents. The ineffectiveness of Paxil, and the link to suicides, meant that it was banned for kids under 18-years-olds in 2008.

The second drug, Avandia was used in Britain to treat diabetes until it was withdrawn due to safety fears, including increased risk of heart attacks. The US government claimed that GSK had attempted to conceal the data surrounding the dangers.

The third drug, Wellbrutin is used in the UK for treating depression, but it was alleged that GSK had recommended physicians used it for ADHD, lost libido and as a slimming aid. None of which were approved uses for the drug.

The moral code of Big Pharma companies exposed...ie they havnt one...........
Sir Andrew Witty, chief executive of GSK said "Whilst these offenses originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made. We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling."

US attorney for Massachusetts, Carmen Ortiz said: "The GSK sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours, to a European pheasant hunt, to tickets to Madonna concerts."

This is the biggest settlement in the history of drug industries, ahead of the 2009 Pfizer case in which it was fined $2.2 billion for promoting four drugs for unapproved uses. In 2010, GSK paid $96 million to a whistle-blower who exposed contamination problems and a management cover up in Puerto Rico.

The practice of pushing drugs for unapproved uses is endemic within the drug industries. Two of the largest drug companies have been caught and fined huge amounts for chasing sales targets using any means necessary. It proves that the health of customers, even children, ranks lower on the companies' agenda than profit. Using bribes to get doctors to prescribe drugs shows a complete lack of moral fiber from both sales teams and the doctors. After this case, surely the doctors also need to face the courts for their conduct.

Whilst the amounts of money seem to be a huge punishment for GSK, the settlement is merely a slap on the wrist for a company whose market value is $133 billion. Can we trust another multinational that promises to clean up its act, when others have promised the same, only to behave just as recklessly but much more surreptitiously.

Sources for this article include:
http://www.dailymail.co.uk
http://www.nytimes.com
http://www.cbsnews.com
http://bottomline.msnbc.msn.com

http://www.naturalnews.com/036385_Gl...d_bribery.html

[actrisski]

Greed is good

-Gordon Gekko