The US regulator who oversaw the approval of the highly-addictive opioid OxyContin got a six-figure gig at the drug’s manufacturer a year later, a new book claims.
Curtis Wright, once a director at the US Food and Drug Administration who oversaw evaluation for pain medication, got a position with a first-year compensation package of $400,000 at Purdue Pharma a year after he led the approval of OxyContin, according to the book “Empire of Pain: The Secret History of the Sackler Dynasty” by Patrick Radden Keefe.
Purdue Pharma’s sale of OxyContin, a formulation of the narcotic oxycodone that was said to slow down the release of the strong painkiller when taken as prescribed, has been associated with the rise of the opioid crisis, according to a trillion-dollar lawsuit filed by nearly all US states.
OxyContin was the “most prescribed brand name narcotic medication” for treating moderate to severe pain by 2001, according to a report by the US Government Accountability Office. Deaths from prescription opioid overdose quadrupled between 1999 to 2019, and the Centers for Disease Control and Prevention recorded 247,000 deaths from prescription opioid overdose over the last two decades.
Keefe’s book explores the lives of the billionaire Sackler family who founded Purdue Pharma and profited off of the sale of OxyContin. Forbes estimates the Sackler family’s net worth at $10.8 billion, as of December 2020.
“This author has refused to correct errors in his past reporting and also blatantly violated journalistic ethics by refusing to meet with representatives for the Sackler family during the reporting of his book,” Daniel S. Connolly, an attorney for the Raymond Sackler family, said in a statement to Insider. “Documents being released in Purdue’s bankruptcy now demonstrate that Sackler family members who served on Purdue’s board of directors acted ethically and lawfully.”
The FDA approved OxyContin in December 1995, originally believing the controlled-release formulation of OxyContin would result in “less abuse potential,” according to the agency’s website. The agency amended the label in 2001, giving OxyContin a “black box” warning it adds on drug with the highest possible abuse potential, per the FDA website.
Keefe wrote Wright had confessed in a sworn deposition that he “might” have written the portion of the FDA package insert that said OxyContin was “believed to reduce the abuse liability of the drug.” Keefe added that Wright would instruct Purdue Pharma to mail him documents at his home office, and conducted reviews of clinical study reports regarding the safety of OxyContin with the help of Purdue Pharma employees.
After Wright left the FDA he spent a year at another company before joining Purdue, according to the book.
“That was sufficient as a cooling-off period, apparently, to allay any concerns that Richard Sackler might have had about the appearance of a conflict of interest,” Keefe wrote.
Purdue Pharma did not have additional comment to add. The FDA declined to comment.
US drug overdose deaths hit record levels last year with more than 81,000 fatalities, according to the CDC. Fentanyl was involved in almost all of them and the dangerous drug is now sweeping the western states, agitated by the COVID-19 pandemic.
The National Institute on Drug Abuse (NIDA) told Insider: “Fentanyl has been found mixed with many other drugs. People who buy drugs such as heroin, cocaine, methamphetamine, and MDMA are frequently not aware that these may be laced with fentanyl.”
Fentanyl, a synthetic opioid generally used in hospitals to treat pain after surgery, is up to 100 times more potent than morphine and 50 times more than heroin, meaning just two milligrams of it can be deadly, only a fraction of the lethal dose needed for the older opiate.
Dr. Paul H. Earley, an addiction medicine physician with the American Society of Addiction Medicine (ASAM) told Insider: “We’re in the middle of a crisis within a crisis. The substance use disorder crisis, which is already with us, is dramatically worsened by COVID-19. Why? Because addiction is a disease of isolation and despair.”
Over 40 states have reported an increase in opioid overdose deaths during the pandemic, accounting for a 38% rise across the country, according to the American Medical Association (AMA).
However, a CDC report revealed that western states have been most afflicted, with a 98% rise in 10 states, largely due to fentanyl use.
Data from California, Washington, Arizona, Texas, and Colorado showed fentanyl deaths increased by 371% between 2017 and 2019.
Jake, who only provided his first name in fear of being arrested for his addiction, told NPR that he has been addicted to opioids for the past six years. He was initially a heroin user and now a fentanyl user.
He said: “I just started smoking [fentanyl] pills because that was the thing that was around; it was so easy to get. Soon as I wake up, I have to have a pill. The high is not very long, so 20 minutes after I smoke a pill, I want to smoke another one, you know?”
COVID-19 is presenting a new set of challenges for drug users
There are over 2 million opioid users in the US, with an average of around 130 opioid overdose deaths a day, the CDC also noted.
Now, COVID-19 is presenting a new set of challenges for drug users.
NIDA also told Insider: “This increased risk of illness is not only due to potentially adverse social circumstances and living conditions, but also to the drugs’ physiological effects on pulmonary, cardiac, metabolic, and immune functions, all of which are targeted by COVID-19 as well.
“As a result, people with substance use disorders who develop coronavirus are much more likely to be hospitalized and to die, compared with the general population.”
A JAMA Psychiatry report found that between March and October, the weekly rate of emergency department visits for drug overdoses increased by up to 45% compared to the same period in 2019.
Fentanyl’s potency and the fact so little is needed to make it deadly is now killing people who had managed their addictions for years.
Help for drug users has also been partially shutdown. A National Council for Behavioral Health survey revealed that 54% of behavioral health organizations have closed their programs while 65% had to turn away, reschedule or cancel appointments due to financial losses and reduced capacity during the pandemic.
Although some of these programs have provided services online, they require the internet and a phone or computer to access.
Distributing naloxone to those at risk of overdosing
One possible solution is the use of naloxone, a medication which temporarily blocks the effects of opioids and ‘reverses’ overdoses. Administered by injection or nasal spray, the potency of fentanyl means extra doses may be needed compared to other opioids.
More than 700,000 doses of naloxone were distributed to people at risk of overdosing last year. However, almost one in three of the sterile syringe programs that offered the medication either ran out of it or had to ration it for three months, according to the CDC.
Dr. Paul H. Earley also told Insider: “I have a Naloxone overdose kit in my car, I have one in my home. And really, the more that that available that becomes, the more lives we’re going to save.”
Opening overdose prevention sites
Opening overdose prevention sites (OPSs), sometimes known as supervised injection sites (SISs) or safe consumption rooms (SCRs), has also been suggested after the success of similar facilities abroad.
Canada is home to the first legal OPS in North America, Insite. Insite opened its doors in Vancouver in 2003, and between 2017 and 2020, medical staff were able to prevent 4,763 drug overdoses.
Over 120 of them exist across 10 countries but there has never been an overdose death recorded in any, the Drug Policy Alliance notes.
Global consulting firm McKinsey & Company has agreed to pay $573 million to settle investigations into its role in boosting the sales of opioid drugs amid an epidemic that has killed nearly half a million Americans, The New York Times reported Wednesday.
McKinsey will not admit wrongdoing in the settlement, which is expected to be filed on Thursday, after coming to an agreement with attorneys general in 47 US states, the District of Columbia, and five territories, according to The Times.
The settlement comes after court documents recently revealed states were pursuing the firm for advising Purdue Pharma LP, maker of OxyContin painkiller, and other opioid manufacturers on how to sell more opioids at the same time the country was attempting to address the opioid crisis.
McKinsey’s settlement also includes limiting its work with some narcotics and making thousands of pages of documents publicly available, sources told The Times. They also said states are expected to use the settlement money on opioid treatment, prevention, and recovery.
McKinsey did not immediately respond to Insider’s request for comment.
In a statement in December, McKinsey said “we recognize that we did not adequately acknowledge the epidemic unfolding in our communities or the terrible impact of opioid misuse and addiction on millions of families across the country.”
Because of this, the statement said, the company stopped working with opioid-specific businesses in 2019.
The statement also said McKinsey’s “work with Purdue was designed to support the legal prescription and use of opioids for patients with legitimate medical needs, and any suggestion that our work sought to increase overdoses or misuse and worsen a public health crisis is wrong.”
Purdue Pharma, one of McKinsey’s clients, pled guilty to three criminal charges over its marketing of OxyContin as part of an $8 billion settlement in October. At the time, the Associated Press said it was “the highest-profile display yet of the federal government seeking to hold a major drugmaker responsible” for the opioid crisis.
In a statement made through a Securities and Exchange Commission filing, Walmart said the suit is “tainted by historical ethics violations.” It also said the suit “unlawfully forces pharmacists to come between patients and their doctors.” Walmart’s statement questions every aspect of the DOJ’s case, which it says is “riddled with factual inaccuracies and cherry-picked documents taken out of context.”
The DOJ lawsuit against the retail giant accuses Walmart of not properly screening prescriptions for opioids, understaffing pharmacies, and pushing employees to fill prescriptions quickly, all of which contributed to rising rates of addiction and abuse, WSJ reported.
The suit is a “transparent attempt to shift blame from DEA’s well-documented failures in keeping bad doctors from prescribing opioids in the first place,” Walmart said in its SEC filing.
The suit is seeking billions of dollars in civil penalties, accusing Walmart of violating the Controlled Substances Act (CSA).Walmart preempted the suit in October, by suing the DOJ and Drug Enforcement Agency, claiming that the federal government was attempting to shift blame to the retailer for its own regulatory failures.
“In contrast to DEA’s own failures, Walmart always empowered our pharmacists to refuse to fill problematic opioids prescriptions, and they refused to fill hundreds of thousands of such prescriptions. Walmart sent DEA tens of thousands of investigative leads, and we blocked thousands of questionable doctors from having their opioid prescriptions filled at our pharmacies,” Walmart said.