The maker of OxyContin is seeking Food and Drug Administration approval to label the controversial painkiller for use by children as young as 6 in a move that could serve to extend the company’s expiring patent on the lucrative drug, The Daily has learned
“They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind — not out of largesse,” said Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University in Palo Alto, Calif. “That’s important for their bottom line.”
The family-owned pharmaceutical company earned an estimated $2.8 billion in revenue last year from sales of the powerful opioid, part of the same drug family as morphine and heroin. Purdue is fiercely guarding its exclusivity in the market through ongoing legal battles, and now, it appears, through a pediatric trial that could stave off competitors for another six months.
Many of the nation’s top pediatric pain experts say Purdue’s children’s trial is, all in all, a good thing. But critics, citing Purdue’s history of criminal marketing practices, worry that use of the drug by children could expand and lead to greater addiction and abuse woes.
“There’s good medical evidence that suggests a brain that’s not fully mature is at greater risk at developing the disease of addiction,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing and the head of psychiatry at Maimonides Medical Center in New York City. The pediatric community underestimates those risks, he said, because they have given too much credence to drugmakers, who have systematically downplayed the dangers.
In a landmark case for the pharmaceutical industry, Purdue in 2007 admitted in court that it misled doctors and the public about OxyContin’s risk of addiction. The company and three top company executives, each charged with a felony, paid $635 million in fines.
OxyContin’s track record for abuse so far is stark. Last year painkillers — mainly oxycodone, as the brand OxyContin, and hydrocodone — caused more deaths than coc aine and heroin combined. The opioid epidemic has killed more than 100,000 people since 1999, more than U.S. military deaths during the Vietnam war.
HARTFORD, Conn., Jan. 7 /PRNewswire/ -- A number of consumer groups and individuals today filed a lawsuit against Purdue Pharma, L.P. ("Purdue") claiming that the drug maker reaped billions in unlawful profit from OxyContin consumers through fraudulent patents and sham lawsuits that blocked generic alternatives to the widely prescribed pain reliever.
Teresa Bright, one of five plaintiffs named in the lawsuit, claimed to have become addicted after using OxyContin that was prescribed to her husband. Bright's "own illegal conduct" is the sole cause of her problem, Purdue Pharma maintained in court papers.
"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.
The profit margin associated with the illicit sale of OxyContin is enormous. Legitimate prices for OxyContin generally range from $.09 to $.13 per milligram compared to illicit prices of up to $1 per milligram. For example, an 80-mg tablet that costs approximately $7 to $8 in a pharmacy can sell for between $50 and $80 illicitly. Therefore, a 100-tablet bottle of 80-mg strength OxyContin purchased legally for approximately $750 can sell for $5,000 to $8,000 illicitly. Law enforcement reporting indicates that the most commonly diverted dosages of OxyContin are the 40-mg and 80-mg varieties.
OXYCONTIN: Price per tablet
$5 - $12
$10 - $20
$30 - $40
$50 - $80
$60 - $160
Sources: Federal, state, local law enforcement authorities and pharmacists
Hartford, CT: (May-08-07) In a lawsuit filed by the Attorney General Richard Blumenthal and state Consumer Protection Commissioner Jerry Farrell Jr. against Stamford-based Purdue Pharma LLC, the maker of the painkiller OxyContin, they alleged that the company propagated illegal marketing practices that led to greater abuse of the highly addictive painkiller. The suit claimed that Purdue Pharma also violated FDA rules by encouraging doctors to prescribe the drug to be administered every eight hours rather than every 12 hours, which has led to misuse, diversion and abuse of Oxycontin by increasing the amount of the drug in circulation. In a settlement reached with 27 states, Purdue agreed to pay $19.5 million as well as not to market the drug for off-label purposes, that is uses other than those approved by the US Food and Drug Administration
Originally posted by captaintyinknots
All I have to say is that it would take me both hands to count on my fingers the number of people I know who have either been killed or put in the hospital by O.C.
This is absolutely disgusting. That drug should be outlawed.
More like kids who have aggressive cancer, and other extreme illness that cause major pain. I do not think they will be giving young kids synthetic heroin for a stuffed knee, or bike wreck..
Originally posted by TruthSeekerMike
Just so everyone knows, if the doctor prescribes oxycodone to you or your child, you are under no obligation to actually have it filled or take the pills. People act like these drug companies own them because they don't have enough sense to just say "no". I couldn't care less if anyone is addicted to anything, I have no business keeping them from their stuff. I just know I would ask the doctor for something not in the opiate category. Why is only worrying about yourself so difficult? Why is thinking for yourself so much more difficult?