Pharma Owners Accused of Lying About OxyContin

The family that owns OxyContin maker Purdue Pharma directed attempts to play down the dangers of the opioid painkiller, suggest previously undisclosed documents included in a court filing by the attorney general of Massachusetts.

The filing includes emails and other internal Purdue communications that mention the Sackler family. It’s the first evidence that appears to link the family with specific decisions made by Purdue about the marketing of OxyContin, which contributed to the U.S. opioid epidemic, The New York Times reported.

In one email, Richard Sackler suggests blaming addicts when the growing problem of opioid abuse became apparent in the early 2000s.

“We have to hammer on abusers in every way possible,” he wrote in the email in 2001, when he was president of Purdue Pharma. “They are the culprits and the problem. They are reckless criminals.”

Sackler, the son of a company founder, said sales representatives should advise doctors to prescribe the highest dosage of the powerful drug because it was the most profitable, according to the court filing, The Times reported.

OxyContin came on the market in 1996, Since then, there have been more than 200,000 prescription opioid overdose deaths in the U.S.

Purdue Pharma has long contended that the Sackler family was not involved in the day-to-day operations of the company. The Sacklers are one of the richest families in the U.S. and their name is on museums and medical schools worldwide, The Times reported.

The court filing is “littered with biases and inaccurate characterizations,” according to a statement from Purdue Pharma, which dismissed suggestions of wrongdoing by it or the Sackler family.

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Oxycontin Maker Selling Opioid Addiction Drug, Too

Monday, Sept. 10, 2018 — Purdue Pharma, the maker of Oxycontin who some have blamed for the epidemic of opioid painkiller addictions, has patented a medicine aimed at curbing those disorders.

The new anti-addiction drug is a fast-acting form of buprenorphine, which helps control drug cravings, CBS News reported. Previously prescribed in either tablet or fast-dissolving strips, the Purdue version comes in a “wafer” that dissolves in only a few seconds.

Richard Sackler, a member of Purdue’s board, is listed as one of the inventors on the patent, CBS said. The Sackler family controls Purdue.

The announcement comes as Purdue finds itself in the middle of numerous lawsuits from states accusing the company of helping to create the opioid addiction crisis.

In one lawsuit, the Massachusetts attorney general accused Purdue of a “deadly, deceptive scheme to sell opioids.” Purdue and the Sackler family deny the allegations.

Last week, Purdue donated $ 3.4 million to the developer of an over-the-counter version of naloxone, a drug often used to prevent a fatal opioid overdose. Purdue said it will not receive royalties from the new form of naloxone, which is being developed by Harm Reduction Therapeutics, CBS said.

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Cigna Says No to OxyContin

Most OxyContin prescriptions will no longer be covered in Cigna group health plans starting in January, the insurance giant announced.

The move is an attempt to help stem the opioid epidemic that has spread across the United States, company officials said.

“Our focus is on helping customers get the most value from their medications — this means obtaining effective pain relief while also guarding against opioid misuse,” Cigna Chief Pharmacy Officer Jon Maesner said in a statement.

Although OxyContin won’t be an option for Cigna customers unless a doctor deems it “medically necessary,” the company said it has signed a contract with the maker of another opioid, known as Xtampza ER.

Xtampza is “an [OxyContin] equivalent with abuse-deterrent properties,” the company said. “Xtampza ER’s abuse-deterrent platform allows the product to maintain its extended-release profile even when cut, crushed or chewed.”

OxyContin also has abuse-deterrent properties, CNN reported, such as being more difficult to crush. One study did find that Xtampza was harder to abuse than OxyContin, but that research was conducted by Xtampza’s manufacturer, Collegium Pharmaceutical, according to the news service.

One drug safety expert noted that abuse deterrence has limitations.

“People don’t recognize that just because they are harder to tamper with doesn’t make them any less addictive or any more effective in chronic non-cancer pain,” Dr. Caleb Alexander, director of the Johns Hopkins Center for Drug Safety and Effectiveness, told CNN.

Alexander added that financial factors may have played a part in Cigna’s decision to drop OxyContin.

But Dr. Charles Argoff, president of the American Academy of Pain Medicine Foundation, told CNN, “We are going down a very bad slippery slope if we allow payers to only make decisions solely on financial grounds.”

Posted: October 2017

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FDA OKs OxyContin for Some Children

By Megan Brooks
Medscape Medical News

Aug. 13, 2015 — The FDA has approved the use of OxyContin in children ages 11 to 16 with severe pain, the agency says on its web site.

The child’s pain must be severe enough to require around-the-clock, long-term treatment and not managed well by other treatments. OxyContin is the brand name for a time-release formula of oxycodone, a narcotic painkiller.

Studies requested by the FDA from the drugmaker of safety in children and teens supported the approval, Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products at the FDA’s Center for Drug Evaluation and Research (CDER), says in a “CDER conversation” posted on the FDA web site.

“The new study data and resulting pediatric indication for OxyContin give doctors more specific information on how to safely manage pain in their pediatric patients” after surgery or trauma, she says. Unlike adults, children must already be taking and tolerating a minimum dose equal to at least 20 milligrams of oxycodone per day for 5 consecutive days before they can be prescribed an equivalent dose of OxyContin, Hertz says.

“This way, the doctor knows that their patient tolerates and responds appropriately to opioids and knows the amount of opioid treatment needed to manage the patient’s pain. When appropriate, the doctor can then convert their patient over to an OxyContin dose that is tailored to their individual needs,” she says.

“OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly,” Hertz says.

The warnings and precautions for children taking this drug are the same as for adults. The full label can be found here.

The FDA will require Purdue Pharma to do postmarketing studies aimed at finding out the safe use of OxyContin in children.

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OxyContin Tops List of Abused Prescription Drugs: Survey

MONDAY Dec. 9, 2013, 2013 — Oxycodone — the active ingredient in OxyContin — and hydrocodone are the most popular drugs among Americans who abuse prescription painkillers, a new study finds.

OxyContin and Percocet are brand names for drugs containing oxycodone. Brand names of drugs that contain hydrocodone include Vicodin and Lortab.

Researchers surveyed more than 3,500 prescription painkiller abusers in 160 drug-treatment programs across the United States. They found that 45 percent of participants favored oxycodone and 30 percent favored hydrocodone.

Both drugs come in pill form, but almost 64 percent of oxycodone abusers and just over one-quarter of hydrocodone abusers crushed the tablets and inhaled the drug. One in five abusers said they sometimes dissolved oxycodone in water and injected it. Less than 5 percent said they injected hydrocodone.

Gender, personality and age were all factors in drug preferences. OxyContin was favored by those who like taking risks and prefer to inject or snort drugs to get high. Young males are likely to fit that profile, the researchers noted.

Hydrocodone was more popular among women, older people, people who didn’t want to inject drugs, and those who prefer to deal with a doctor or friend instead of a drug dealer, according to the study in the December issue of the journal Pain.

Both drugs are opioids — a class of narcotics.

“Opioids are prescribed to treat pain, but their misuse has risen dramatically in recent years,” principal investigator Theodore Cicero, a researcher at Washington University, St. Louis, who studies prescription drug abuse, said in a university news release. “Our goal is to understand the personal characteristics of people who are susceptible to drug abuse, so we can detect problems ahead of time.”

The survey found that 54 percent of respondents preferred the high they got from oxycodone, while 20 percent said the high from hydrocodone was better.

“Among the reasons addicts prefer oxycodone is that they can get it in pure form,” said Cicero, a professor of neuropharmacology in psychiatry. “Until recently, all drugs with hydrocodone as their active ingredient also contained another product such as acetaminophen, the pain reliever in Tylenol. That turns out to be very important because addicts don’t like acetaminophen.”

When injected, acetaminophen causes considerable irritation. When swallowed in large amounts, it can cause severe liver damage.

“Interestingly, addicts, while they’re harming their health in one respect by taking these drugs, report being very concerned about the potentially negative side effects of acetaminophen,” Cicero said.

More information

The U.S. Centers for Disease Control and Prevention has more about prescription painkiller abuse.

Posted: December 2013

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FDA Approves ‘Abuse-Deterrent’ Label for New Oxycontin

Latest formulation is tougher to crush and dissolve, making illicit use more difficult

WebMD News from HealthDay

By EJ Mundell

HealthDay Reporter

TUESDAY, April 16 (HealthDay News) — In an effort to help curb the epidemic of prescription painkiller abuse, the U.S. Food and Drug Administration on Tuesday said it is approving new labeling for a reformulated version of Oxycontin that its maker claims will be harder to abuse.

The agency also noted that the original form of the powerful painkiller has been withdrawn from the market because it is easier to abuse than the newer formulation.

“Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin,” the FDA added in a news release issued late Tuesday.

Prescription painkiller abuse continues to be a major problem across the United States. According to a report issued in January by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), some 22 million Americans — 2 percent of the population — have misused prescription painkillers since 2002.

Oxycontin (oxycodone hydrochloride controlled-release) already has Schedule II status as a potentially harmful and restricted-access narcotic, based on an FDA review. In January, an agency advisory panel voted to move other hydrocodone-containing painkillers such as Vicodin and Percocet to the same status.

One other way to rein in rampant abuse of precription narcotics is to develop formulations that are more difficult to break down and abuse.

The original form of Oxycontin, first approved in 1995, “was abused, often following manipulation intended to defeat its extended-release properties,” the FDA explained. “Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”

The new, “abuse-deterrent” version was approved in 2010 after being developed by maker Purdue Pharma, and the company stopped shipments of the older version of Oxycontin to pharmacies in August of that year.

The new version is “more difficult to crush, break or dissolve,” the FDA said, and it forms a thick, sticky gel that resists being used as an injection. It is also more difficult to manipulate the drug so it can be snorted, the agency said.

“The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube,” the agency noted.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in the agency’s news release. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”

The FDA notes that postmarketing studies looking at the abuse potential of the new formulation are ongoing.

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Study: OxyContin Abuse Deterrent Doubles Heroin Use

New England Journal of Medicine: New OxyContin Abuse-Deterrent Formulation Drove Surge in Heroin Use 

New Research Indicates Former OxyContin Users Now Using Easier-to-Get Heroin

Drug prohibition does not work. Due to a steady, base-level demand for narcotics, when drug warriors try to stem the tide in one area, it only diverts demand to somewhere else — sometimes making the problem worse.

In a perfect illustration of this principle, the New England Journal of Medicine on Thursday released research showing that the recent introduction of the reformulated, abuse-deterrent version of OxyContin is linked to increases in heroin use.

In a letter-to-the-editor appearing in the Journal, Theodore Cicero, Ph.D., Matthew Ellis, M.P.E., and Hilary Surratt, Ph.D., wrote, “Our data show that an abuse-deterrent formulation successfully reduced abuse of a specific drug but also generated an unanticipated outcome: replacement of the abuse-deterrent formulation with alternative opioid medications and heroin, a drug that may pose a much greater overall risk to public health than OxyContin.”

Harm reduction advocates were disheartened, but not surprised at the findings.

“We’ve long known that simply making OxyContin more difficult to crush or inject would simply lead people to the next easiest drug to abuse, namely heroin. So while we’re disheartened to have our beliefs proved true, none of us are surprised,” said Meghan Ralston, harm reduction coordinator the Drug Policy Alliance.

“No one thought to radically expand access to free drug treatment or free methadone when the new Oxy formula hit the market,” Ralston said. “There’s a bit of a frenzy in the U.S. to radically reduce prescription opioid abuse, but caution is needed. We urge all states attempting to ‘crack down’ on prescription opioid abuse to first plan for the unintended consequences, like those revealed in this research.”

Cicero, Ellis and Surratt collected data quarterly from more than 2,500 opioid users entering drug treatment programs across the country from July 2009 through March 2012. While the selection of OxyContin as the primary drug of abuse use did indeed decrease during that time, selection  of high-potency fentanyl and hydromorphone “rose markedly,” according to Cicero and Ellis.

Their research indicates that heroin use nearly doubled.

“Abuse-deterrent formulations may not be the ‘magic bullets’ that many hoped they would be in solving the growing problem of opioid abuse,” said the researchers.

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Drug-Free Housing Helps Heroin, Oxycontin Addicts Recover

TUESDAY Feb. 28, 2012 — Drug-free recovery housing and day treatment programs greatly improve the chances that those addicted to opioids who have gone through detoxification will be able to kick the habit, a new study shows.

Opioid abuse includes both the use of illegal drugs such as heroin and the nonmedical use of prescription painkillers such as OxyContin, Vicodin and Percocet.

Opioid addicts seeking treatment typically start with detoxification, but relapse rates within a month of undergoing detox as a standalone treatment are between 65 percent and 80 percent, according to background information in the study from Johns Hopkins University School of Medicine researchers.

They found that opioid addicts who were provided with drug-free recovery housing and day treatment programs after detox were up to 10 times more likely to remain drug-free.

The researchers followed 243 opioid addicts — primarily heroin users — after the addicts’ release from detox. After six months, the abstinence rate for those who had no follow-up housing or treatment was 13 percent, compared with 37 percent for those who received housing and 50 percent for those who received housing and day treatment.

Throughout the study period, participants who received housing and day treatment were twice as likely to remain drug-free as those who received housing only, and 10 times more likely to remain drug-free than those who received no housing or day treatment.

The study was published online Feb. 27 in the journal Addiction.

“It’s no surprise that opioid-dependent individuals stay off drugs longer when they live in a structured, drug-free environment after finishing detox. Drug-dependent individuals frequently report housing as their most pressing need,” lead researcher Michelle Tuten said in a journal news release.

“If we want to help people stay off heroin and stop abusing prescription painkillers, we need to do more than help them initiate abstinence; we need to help them maintain abstinence and build a drug-free lifestyle as well,” she said. “Improved access to drug-free recovery housing and day-treatment programs would clearly move us closer to that goal.”

More information

The U.S. National Institute on Drug Abuse has more about treatment for drug addiction.

Posted: February 2012

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OxyContin, Presribing Habits & Pharma Influence

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