from the prevent-pill-popping dept.
Pain-pill giant Purdue Pharma LP will stop promoting its opioid drugs to doctors, a retreat after years of criticism that the company's aggressive sales efforts helped lay the foundation of the U.S. addiction crisis.
The company told employees this week that it would cut its sales force by more than half, to 200 workers. It plans to send a letter Monday to doctors saying that its salespeople will no longer come to their clinics to talk about the company's pain products.
"We have restructured and significantly reduced our commercial operation and will no longer be promoting opioids to prescribers," the company said in a statement. Instead, any questions doctors have will be directed to the Stamford, Connecticut-based company's medical affairs department.
OxyContin, approved in 1995, is the closely held company's biggest-selling drug, though sales of the pain pill have declined in recent years amid competition from generics. It generated $1.8 billion in 2017, down from $2.8 billion five years earlier, according to data compiled by Symphony Health Solutions. It also sells the painkiller Hysingla.
Related: Opioid Crisis Partly Blamed on a 1980 Letter to the New England Journal of Medicine
President Trump Declares the Opioid Crisis a National Emergency
Study Finds Stark Increase in Opioid-Related Admissions, Deaths in Nation's ICUs
CVS Limits Opioid Prescriptions
Congress Reacts to Reports that a 2016 Law Hindered DEA's Ability to go after Opioid Distributors
Opioid Crisis Official; Insys Therapeutics Billionaire Founder Charged; Walgreens Stocks Narcan
An American city is suing the maker of OxyContin for its alleged role in fueling the national opioid epidemic:
After spending millions to combat the opioid epidemic ravaging its citizens, the working-class city of Everett, Washington, is taking the maker of opioid painkiller OxyContin to federal court. The city claims that the drug maker, Purdue Pharma, knowingly sold to black markets out of pure greed, enabling the devastating epidemic hitting Everett and the rest of the country.
According to the lawsuit (PDF) filed in federal court in Seattle, Everett accuses Purdue Pharma of "knowingly, recklessly, and/or negligently supplying OxyContin to obviously suspicious physicians and pharmacies and enabling the illegal diversion of OxyContin into the black market, including to drug rings, pill mills, and other dealers for dispersal of the highly addictive pills in Everett." Purdue's goal, Everett alleges, was to "generate enormous profits" at the expense of the people of Everett. [...] "Our community has been significantly damaged, and we need to be made whole," Everett's mayor, Ray Stephanson, told ABC News.
[...] In a statement, Purdue disputed Everett's claims, saying that it did notify the DEA and acted responsibly. "We look forward to presenting the facts in court," the company said. Purdue also said that its opioids now account for less than two percent of US opioid prescriptions.
Arthur T Knackerbracket has found the following story:
Patients would no longer have to wake up in the middle of the night to take their pills, Purdue told doctors. One OxyContin tablet in the morning and one before bed would provide "smooth and sustained pain control all day and all night."
When Purdue unveiled OxyContin in 1996, it touted 12-hour duration.
On the strength of that promise, OxyContin became America's bestselling painkiller, and Purdue reaped $31 billion in revenue.
But OxyContin's stunning success masked a fundamental problem: The drug wears off hours early in many people, a Los Angeles Times investigation found. OxyContin is a chemical cousin of heroin, and when it doesn't last, patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug.
The problem offers new insight into why so many people have become addicted to OxyContin, one of the most abused pharmaceuticals in U.S. history.
Over the last 20 years, more than 7 million Americans have abused OxyContin, according to the federal government's National Survey on Drug Use and Health. The drug is widely blamed for setting off the nation's prescription opioid epidemic, which has claimed more than 190,000 lives from overdoses involving OxyContin and other painkillers since 1999.
The internal Purdue documents reviewed by The Times come from court cases and government investigations and include many records sealed by the courts. They span three decades, from the conception of OxyContin in the mid-1980s to 2011, and include emails, memos, meeting minutes and sales reports, as well as sworn testimony by executives, sales reps and other employees.
The documents provide a detailed picture of the development and marketing of OxyContin, how Purdue executives responded to complaints that its effects wear off early, and their fears about the financial impact of any departure from 12-hour dosing.
Researchers have found that a one paragraph letter to the New England Journal of Medicine in 1980 was "uncritically cited as evidence that addiction was rare with long-term opioid therapy" [emphasis in original retained]:
Canadian researchers have traced the origins of the opioid crisis to one letter published almost 40 years ago.
The letter, which said opioids were not addictive, was published in the New England Journal of Medicine (NEJM) in 1980.
Dr David Juurlink says the journal's prestige helped fuel the misguided belief that opioids were safe.
His research found that the letter was cited more than 600 times, usually to argue that opioids were not addictive.
On Wednesday, the NEJM published Dr Juurlink's rebuttal to the 1980 letter, along with his team's analysis of the number of times the letter was cited by other researchers.
The two names to blame? Dr. Hershel Jick and his assistant Jane Porter. Dr. Jick did not anticipate the misuse of his short letter:
Jick still works at Boston University School of Medicine. He told the Associated Press this week that he is "essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did."
"They used this letter to spread the word that these drugs were not very addictive," he said. Jick noted that he testified as a government witness in a lawsuit some years ago concerning the marketing of pain drugs.
After some initial confusion about the White House's plans earlier in the week, President Trump has followed the recommendation of the President's Commission on Combating Drug Addiction and the Opioid Crisis, headed by New Jersey Governor Chris Christie, and declared the opioid crisis to be a national emergency. He has promised to spend "a lot" of time, effort, and money to combat the problem:
Among the other recommendations were to rapidly increase treatment capacity for those who need substance abuse help; to establish and fund better access to medication-assisted treatment programs; and to make sure that health care providers are aware of the potential for misuse and abuse of prescription opioids by enhancing prevention efforts at medical and dental schools.
President Trump also decried a slowdown in federal prosecutions of drug crimes and a reduction in sentence lengths. Activists and policy experts are wary of an enforcement-heavy approach:
Bill Piper, senior director for the Drug Policy Alliance, told CNN Tuesday that stricter enforcement "has never worked" and the President would be "better focusing on the treatment side of things." "A supply side approach to drugs has never worked," Piper said. "That is what has been tried for decades and it has failed for every drug it has applied to, including alcohol during Prohibition. As long as there has been and[sic] demand for drugs, there will be a supply." Trump would not be the first administration to crack down on drug use by focusing on enforcement, but Piper said doing so would play into a desire to "sound tough," not actually solve the problem. "It makes it look like they are doing something even when they are not," Piper said.
Trump also advocated for more abstinence-based treatment to combat the opioid crisis. "The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don't start, they won't have a problem. If they do start, it's awfully tough to get off," Trump said. That sort of strategy advocates for targeting kids and young adults with anti-drug messaging, evocative of the "Just Say No" ad campaign of the 1980s and early 1990s.
This crisis is serious, folks:
"It is a serious problem the likes of which we have never had. You know when I was growing up, they had the LSD and they had certain generations of drugs. There's never been anything like what's happened to this country over the last four or five years. And I have to say this in all fairness, this is a worldwide problem, not just a United States problem. This is happening worldwide. But this is a national emergency, and we are drawing documents now to so attest."
Since 2009, hospital intensive care units have witnessed a stark increase in opioid-related admissions and deaths, according to new study led by researchers at Beth Israel Deaconess Medical Center’s (BIDMC) Center for Healthcare Delivery Science. Published online today ahead of print in the Annals of the American Thoracic Society, the study is believed to be the first to quantify the impact of opioid abuse on critical care resources in the United States. The findings reveal that opioid-related demand for acute care services has outstripped the available supply.
Analyzing data from the period between January 1, 2009 and September 31, 2015, the researchers documented a 34 percent increase in overdose-related ICU admissions. The average cost of care per ICU overdose admissions rose by 58 percent, from $58,517 in 2009 to $92,408 in 2015 (in 2015 dollars). Meanwhile opioid deaths in the ICU nearly doubled during that same period. "This study tells us that the opioid epidemic has made people sicker and killed more people, in spite of all the care we can provide in the ICU, including mechanical ventilation, acute dialysis, life support and round-the-clock care," said the study's lead author, Jennifer P. Stevens, MD, associate director of the medical intensive care unit at BIDMC and assistant professor of medicine at Harvard Medical School.
[...] These data not only document the scope of the opioid abuse epidemic, they also reveal its complexity. Stevens and colleagues suggest that any opioid overdose-related admission is a preventable one, and that the team's findings not only represent the need for increased acute care resources, but also for expanded opioid-abuse prevention and treatment.
The article is paywalled but there is an abstract: The Critical Care Crisis of Opioid Overdoses in the United States
-- submitted from IRC
South Carolina has become the sixth U.S. state to sue opioid makers over their marketing practices and contribution to the opioid epidemic:
The lawsuit by South Carolina Attorney General Alan Wilson, filed in Richland County Court of Common Pleas in Columbia, accuses the company of the unfair and deceptive marketing of opioid painkillers. Wilson claimed Purdue has told doctors that patients who receive prescriptions for opioids generally will not become addicted and those who appeared to be were only "pseudoaddicted" and needed more of the drugs.
[...] Since a 2007 settlement with South Carolina, Purdue has continued to downplay the addictiveness of its opioid products and overstated the benefits compared to other pain management treatments, according to the lawsuit. "While there is a time and place for patients to receive opioids, Purdue prevented doctors and patients from receiving complete and accurate information about opioids in order to make informed choices about their treatment options," Wilson said in a statement.
Stamford, Connecticut-based Purdue denied the allegations and said it shares the concerns of South Carolina officials about the crisis and is committed to finding solutions. Purdue and other drugmakers have been sued over opioid products by Oklahoma, Mississippi, Ohio, Missouri and New Hampshire as well as cities and counties in California, Illinois, Ohio, Oregon, Tennessee and New York.
Is this Big Pharma's Tobacco Moment?
Drug-store chain CVS Health announced Thursday that it will limit opioid prescriptions in an effort to combat the epidemic that accounted for 64,000 overdose deaths last year alone.
Amid pressure on pharmacists, doctors, insurers and drug companies to take action, CVS also said it would boost funding for addiction programs, counseling and safe disposal of opioids.
[...] The company's prescription drug management division, CVS Caremark, which provides medications to nearly 90 million people, said it would use its sweeping influence to limit initial opioid prescriptions to seven-day supplies for new patients facing acute ailments.
It will instruct pharmacists to contact doctors when they encounter prescriptions that appear to offer more medication than would be deemed necessary for a patient's recovery. The doctor would be asked to revise it. Pharmacists already reach out to physicians for other reasons, such as when they prescribe medications that aren't covered by a patient's insurance plan.
The plan also involves capping daily dosages and initially requiring patients to get versions of the medications that dispense pain relief for a short period instead of a longer duration.
[...] "The whole effort here is to try to reduce the number of people who are going to end up with some sort of opioid addiction problem," CVS Chief Medical Officer Troyen Brennan said in an interview.
It appears this initiative is limited to initial filling of prescriptions — there is no mention of changes in the handling of refills.
Congress has responded strongly to a joint investigation by CBS and The Washington Post (archive) about Drug Enforcement Administration (DEA) employees becoming lobbyists for the pharmaceutical industry, and the passage of a bill in 2016 hobbling the DEA's ability to go after opioid distributors and suspicious drug sales:
Lawmakers and the Drug Enforcement Administration are facing tough questions following an explosive joint investigation by "60 Minutes" and The Washington Post that says Congress helped disarm the DEA.
Drug overdose deaths in the United States have more than doubled over the past decade. The CDC says 188,000 people have died from opioid overdoses from 1999 to 2015.
Joe Rannazzisi used to run the DEA's diversion control. He told "60 Minutes" correspondent Bill Whitaker that the opioid crisis was aided in part by Congress, lobbyists and the drug distribution industry. The DEA says it has taken actions against far fewer opioid distributors under a new law. A Justice Department memo shows 65 doctors, pharmacies and drug companies received suspension orders in 2011. Only six of them have gotten them this year.
[...] [The] DEA's efforts may have been undermined by the so-called "revolving door" culture in Washington. At least 46 investigators, attorneys and supervisors from the DEA, including 32 directly from the division that regulates the drug industry, have been hired by the pharmaceutical industry since the scrutiny on distributors began.
From The Washington Post:
The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump's nominee to become the nation's next drug czar. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin G. Hatch (R-Utah) negotiated a final version with the DEA.
"The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don't start, they won't have a problem." – President Donald J. Trump
President Trump has declared the "Opioid Crisis" a nationwide public health emergency. This action will allow for "expanded access to telemedicine services" to remotely prescribe medicines for substance abuse, allow the Department of Health and Human Services to "more quickly make temporary appointments of specialists with the tools and talent needed to respond effectively to our Nation's ongoing public health emergency", allow the Department of Labor to issue dislocated worker grants for those "displaced from the workforce" due to the Opioid Crisis, and will help people with HIV/AIDS to receive substance abuse treatment. The press release lists several actions that the Trump Administration has taken to respond to the Opioid Crisis, including the July 2017 law enforcement action against AlphaBay.
The declaration has been criticized for not requesting any funds to respond to the Crisis. The "nationwide public health emergency" declaration is also distinct from a promised "national emergency declaration", which would have freed up money from the Disaster Relief Fund to be spent on the Crisis. 14 Senate Democrats have introduced a bill that would authorize $45 billion to address the Opioid Crisis. The Obama Administration called on Congress last year to pass just over $1 billion in funding for opioid treatment programs nationwide. This funding was included in the 21st Century Cures Act.
The Department of Justice has arrested and charged the founder and majority owner of Insys Therapeutics Inc., John Kapoor, along with other executives from his company. Kapoor is accused with leading a nationwide conspiracy to bribe doctors and illegally distribute the company's fentanyl spray, intended for cancer patients, so that it could be prescribed for non-cancer patients. Kapoor stepped down as CEO of Insys in January. Acting U.S. Attorney William D. Weinreb said, "Mr. Kapoor and his company stand accused of bribing doctors to overprescribe a potent opioid and committing fraud on insurance companies solely for profit. Today's arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles. We must hold the industry and its leadership accountable - just as we would the cartels or a street-level drug dealer." Six former Insys executives and managers were charged in December.
Following hundreds of lawsuits over the years against pharmaceutical giant Purdue Pharma, Colorado's attorney general is suing the OxyContin creator for its "significant role in causing the opioid epidemic." The lawsuit claims Purdue Pharma L.P. and Purdue Pharma Inc. deluded doctors and patients in Colorado about the potential for addiction with prescription opioids and continued to push the drugs. And it comes amid news that the company's former chairman and president, Richard Sackler, has patented a new drug to help wean addicts from opioids.
[...] In federal court in 2007, three top current and former employees for Purdue pleaded guilty to criminal charges, admitting that they had falsely led doctors and their patients to believe that OxyContin was less likely to be abused than other drugs in its class, according to The New York Times. Then earlier this year, the Wall Street Journal reported that Purdue planned to stop promoting the drug.
Now, it seems, a new business venture is only adding to the outcry. The Financial Times reported that Sackler, whose family owns Purdue Pharma, a multibillion-dollar company, patented a new drug earlier this year that is a form of buprenorphine, a mild opioid that is used to ease withdrawal symptoms. However, some are expressing outrage that the Sacklers, who have in essence profited from opioid addictions, may soon be profiting from the antidote. "It's reprehensible what Purdue Pharma has done to our public health," Luke Nasta, director of Camelot, a New York-based treatment center for drug and alcohol addiction, told the Financial Times. He told the newspaper that the Sackler family "shouldn't be allowed to peddle any more synthetic opiates - and that includes opioid substitutes."
Financial Times also reported that the Sackler family owns Rhodes Pharma, "a little-known Rhode Island-based drugmaker that is among the largest producers of off-patent generic opioids in the U.S."
Also at The Independent.
Previously: City of Everett, Washington Sues OxyContin Maker Purdue Pharma
OxyContin's 12-Hour Problem
South Carolina Sues OxyContin Maker Purdue
Purdue Pharma to Cut Sales Force, Stop Marketing Opioids to Doctors
Tens or Hundreds of Billions of Dollars Needed to Combat Opioid Crisis? (Massachusetts Attorney General sues Sackler family)
Synthetic opioids such as fentanyl have overtaken prescription opioids as the No. 1 killer in the opioid epidemic, according to a new report.
The report, published Tuesday in the journal JAMA [DOI: 10.1001/jama.2018.2844] [DX], calculated the number and percentage of synthetic opioid-related overdose deaths in the United States between 2010 and 2016 using death certificates from the National Vital Statistics System. The researchers found that about 46% of the 42,249 opioid-related overdose deaths in 2016 involved synthetic opioids such as fentanyl, while 40% involved prescription drugs.
That's more than a three-fold increase in the presence of synthetic opioids from 2010, when synthetic drugs were involved in approximately 14% of opioid-overdose deaths.
Related: Heroin, Fentanyl? Meh: Carfentanil is the Latest Killer Opioid
Study Finds Stark Increase in Opioid-Related Admissions, Deaths in Nation's ICUs
U.S. Life Expectancy Continues to Decline Due to Opioid Crisis
Purdue Pharma to Cut Sales Force, Stop Marketing Opioids to Doctors
The More Opioids Doctors Prescribe, the More Money They Make
Two More Studies Link Access to Cannabis to Lower Use of Opioids