6-5-19 In April 2018 the United States intervened in five qui tam lawsuits accusing Insys of violating the civil False Claims Act. In its Complaint, the United States alleged that Insys, headquartered in Arizona, paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients. In addition to payments for sham speaker program speeches, the kickbacks also allegedly took the form of jobs for the prescribers’ relatives and friends, and lavish meals and entertainment. The United States also alleged that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries. https://www.justice.gov/opa/pr/opioid-manufacturer-insys-therapeutics-agrees-enter-225-million-global-resolution-criminal
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9-18-19 The civil trial promises to expose evidence suggesting that hundreds of companies made deceptive claims about opioids, flooded the market with the highly addictive products and looked the other way as the body count mounted….Some 652,000 Americans use heroin, and roughly 80% of them are thought to have started down that road by misusing prescription narcotics.
https://www.latimes.com/science/story/2019-09-17/opioid-lawsuit-who-is-to-blame
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10-19-2016 Fueled by cut-rate Indian exports and inaction by world narcotics regulators, tramadol dependency extends across Africa, the Middle East and into parts of Asia and Eastern Europe. …But recent research shows that tramadol taken orally can have a stronger impact on users than morphine. International regulators say they now realize tramadol is heavily abused in some places….
“All we know is that it’s a gray market,” says Gopal Agarwal, who ships tramadol to Benin from his factory, Pharmalink Laboratories, in an office park in a Mumbai suburb.
In Nigeria, where it is illegal to distribute the narcotic without a license, authorities confiscated shipments that weren’t approved by the government’s drug-control agency.
Exporters say they responded by sending tramadol to middlemen in Benin, a tiny West African country with lax drug restriction. Benin is “the second-largest recipient of registered commercial freight shipments from India of the prescription drug tramadol,” the U.S. State Department wrote in March.
Mr. Sharma and a half-dozen other drug exporters in Mumbai say they ship drugs to Benin for their clients to distribute across the region, through Nigeria and into Cameroon. “We don’t know how they are distributing to other countries, to Nigeria,” said the head of Aveo Pharmaceuticals Pvt., Arvind Sharma, who isn’t related to Raju Sharma. https://www.wsj.com/articles/tramadol-the-opioid-crisis-for-the-rest-of-the-world-1476887401
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9-6-19 And as with the U.S., Australia’s government has also been slow to respond to years of warnings from worried health experts.
In dozens of interviews doctors, researchers and Australians whose lives have been upended by opioids described a plight that now stretches from coast to coast. Australia’s death rate from opioids has more than doubled in just over a decade. https://apnews.com/cfc86f47e03843849a89ab3fce44c73c
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As the company later admitted, it misleadingly promoted OxyContin as less addictive than older opioids on the market. In this deception Purdue had a big assist from the FDA, which allowed the company to include an astonishing labeling claim in OxyContin’s package insert: “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.” The theory was that addicts would shy away from timed-released drugs, preferring an immediate rush. In practice OxyContin, which crammed a huge amount of pure narcotic into a single pill, became a lusted-after target for addicts, who quickly discovered that the timed-release mechanism in OxyContin was easy to circumvent—you could simply crush a pill and snort it to get most of the narcotic payload in a single inhalation….
The year after OxyContin’s release, Curtis Wright, the FDA examiner who approved the pharmaceutical’s original application, quit. After a stint at another pharmaceutical company, he began working for Purdue. In an interview with Esquire Wright defended his work at the FDA and at Purdue….
Between 1996 and 2001 the number of OxyContin prescriptions in the United States surged from about three hundred thousand to nearly six million, and reports of abuse started to bubble up in places like West Virginia, Florida, and Maine. (Research would later show a direct correlation between prescription volume in an area and rates of abuse and overdose.) Hundreds of doctors were eventually arrested for running pill mills. According to an investigation in the Los Angeles Times, even though Purdue kept an internal list of doctors it suspected of criminal diversion, it didn’t volunteer this information to law enforcement until years later….
in July 2001, Richard Blumenthal, then Connecticut’s attorney general and now a U. S. senator, called the company’s efforts “cosmetic.” As Blumenthal had deduced, the root problem of the prescription-opioid epidemic was the high volume of prescriptions written for powerful opioids. “It is time for Purdue Pharma to change its practices,” Blumenthal warned Richard Sackler, “not just its public-relations strategy.” It wasn’t just that doctors were writing huge numbers of prescriptions; it was also that the prescriptions were often for extraordinarily high doses….
On April 16, 2013, the day some of the key patents for OxyContin were scheduled to expire, the FDA followed Purdue’s lead, declaring that no generic versions of the original OxyContin formulation could be sold. The company had effectively won several additional years of patent protection for its golden goose….The Sacklers, though, will likely emerge untouched: Because of a sweeping non-prosecution agreement negotiated during the 2007 settlement, most new criminal litigation against Purdue can only address activity that occurred after that date. Neither Richard nor any other family members have occupied an executive position at the company since 2003. https://www.esquire.com/news-politics/a12775932/sackler-family-oxycontin/
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