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Startup raises $15M to help prevent and treat opioid addiction

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A startup building tools to prevent opioid addiction closed a $15 million funding round. AxialHealthcare raised the new funds from previous investors, including Oak HC/FT, .406 Ventures, BlueCross BlueShield Venture Partners and the Sandbox Advantage Fund. The company plans to use the additional funds to build tools to support patients struggling with addiction and connect them with resources in their communities.

“It’s not one size fits all. We want to go really deep into communities and understand exactly how the epidemics affect the community, what providers are there and which providers offer quality care,” said Carter Paine, who became axialHealthcare’s CEO last year. “We plan to use the funding to support our expansion in terms of putting feet on the street in those communities that we serve.”

Nashville-based axialHealthcare originally started as an analytics company, which analyzed claims data to help providers identify patients at risk of addiction. For example, it can show how many other physicians have prescribed a patient opioids in the past, or if they had been admitted to the ER for an overdose. The company struck a partnership with Surescripts in 2018 to add prescription fill data to its platform.

Now, axialHealthcare is building out tools for patients and their families to help them navigate substance use disorder treatment and recovery. For example, it has a tool that directs patients to the top-performing pain care providers. It also helps them connect to community resources, such as transportation, housing or job assistance programs.

“It’s one of the hardest areas to navigate. Patients and families are often just going to Google, which is not enough info on where is there high-quality treatment in community and what is the right level of care for a patient as they deal with this disease,” Paine said.

The startup also has a separate app that directly engages patients, connecting them to a health coach that can support them in their treatment.

“We want to be that trusted support and advocate,” Paine said. “It’s a wickedly hard disease to conquer or to go into remission on. Anyone who has gone through this would tell you they had people they leaned on as they go through recovery.”

Oak HC/FT General Partner Nancy Brown, who joined axialHealthcare’s board in 2016 after her firm led a $16.5 million round in the startup, said the company broadening its tools across the entire spectrum from substance abuse to treatment would allow it to have a bigger impact.

“We have been focused on solutions associated with the opioid addiction crisis since our earlier investment in axial. It became clear that in order to have the substantial and sustained impact we hoped for we needed to broaden our tools to support the entire continuum from prevention to treatment,” she said in an emailed statement. “Carter Paine is an experienced leader who has proven ability to take a disconnected healthcare ecosystem and provide tech enabled services to drive improvement to clinical outcomes and costs at scale.”

Paine joined axialHealthcare last year from his previous startup, NaviHealth, a post-acute care company. AxialHealthcare’s former CEO, John Donahue, became executive chairman of the company last year.

Seven health plans currently use axialHealthcare services, covering a few million members. In addition to building out its platforms, the company plans to build out the number of clients it serves.

Photo credit: VladimirSorokin, Getty Images

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Beset by lawsuits, criticism in U.S., opioid makers eye new market In India

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American pharma companies — architects of the opioid crisis in the United States and avid hunters of new markets — stand at the ready to feed and fuel demand for painkillers in India where attitudes toward pain toleration have changed.

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Reports: Sackler family offers to relinquish reins of Purdue Pharma to resolve opioid suits

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The family that owns Purdue Pharma would give up control of the opioid maker under a settlement it has proposed to resolve thousands of lawsuits at the federal and state level, according to published reports.

Citing anonymous people familiar with the matter, several outlets reported Tuesday that the Sackler family would give up control of the Stamford, Connecticut-based company and pay $3 billion of its own money toward a settlement worth $10-12 billion. The New York Times reported that rather than being a simple payout, most of the money would come from a restructuring resulting from a Chapter 11 bankruptcy filing. The Wall Street Journal reported that the discussions – to resolve more than 2,000 lawsuits – have been ongoing for more than a year and remain in flux. Lawyers for the company and the plaintiffs have until Friday to give an update to Judge Dan Polster of the U.S. District Court for the Northern District of Ohio, in Cleveland.

In March, Reuters reported that Purdue was exploring a Chapter 11 bankruptcy filing so that it could negotiate claims with plaintiffs in the suits. It was reported at the time that the bankruptcy filing would stop the lawsuits and allow the company to negotiate with the plaintiffs, under the supervision of a bankruptcy judge.

Purdue is the maker of OxyContin, a long-acting form of the opioid painkiller oxycodone and a central culprit in the nationwide opioid crisis. According to the National Institute on Drug Abuse, overdose deaths in the U.S. related to prescription opioids rose from 3,442 in 1999 – four years after the Food and Drug Administration approved OxyContin – to 17,029 in 2017.

On Monday, a judge in Oklahoma ruled that Johnson & Johnson would have to pay $572 million in a case against the company for its role in the opioid epidemic. However, an investment bank analyst wrote in a report that the case has little direct read-through to a larger multi-district litigation case in October.

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Johnson & Johnson ordered to pay $572M in Oklahoma opioid lawsuit

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A court in Oklahoma has ordered Johnson & Johnson to pay more than half a billion dollars over allegations that it helped to fuel the opioid crisis.

The Cleveland County District Court in Norman, Oklahoma, issued a civil judgment requiring the drugmaker to pay $572 million. Judge Thad Balkman ruled that J&J had created a “public nuisance” in the state.

The company said it plans to appeal the decision, which it called “flawed.”

“Janssen did not cause the opioid crisis in Oklahoma, and neither the facts or the law support this outcome,” J&J general counsel Michael Ullman said in a statement, referring to the drugmaker’s Janssen Pharmaceutical Companies subsidiary. “We recognize the opioid crisis is a tremendously complex public health issue, and we have deep sympathy for everyone affected.”

Shares of J&J were up nearly 2 percent in after-hours trading on the New York Stock Exchange following the ruling.

In a note to investors, SVB Leerink analyst Ami Fadia wrote that although the amount is higher than the $270 million that Purdue Pharma had to pay, or the $85 million judgment against Teva Pharmaceutical Industries, it is still much lower than the $17.2 billion that Oklahoma Attorney General Mike Hunter had been seeking. Moreover, citing numbers from IQVIA, Fadia wrote that J&J’s opioid sales historically were lower than those of Purdue and Teva.

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Expert panel to review Nektar drug delayed as FDA postpones opioid meetings

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The Food and Drug Administration has delayed an expert panel meeting for an investigational opioid painkiller, causing shares of the company developing it to drop.

In a filing with the Securities and Exchange Commission Thursday, San Francisco-based Nektar Therapeutics said it had received notice that the FDA would postpone product-specific advisory committee meetings regarding opioid analgesics “while the agency continues to consider a number of scientific and policy issues relating to this class of drugs.”

That postponement also delays the scheduled Aug. 21 meeting that would have included a discussion of Nektar’s regulatory approval application for the drug NKTR-181, an opioid that the company has been developing for pain. Consequently, the agency may not be able to reach a decision of whether or not to approve the drug by the original Prescription Drug User Fee Act (PDUFA) deadline of Aug. 29, according to the filing.

Nektar describes NKTR-181 as the first full mu-opioid agonist that is designed to provide pain relief without the euphoria that leads to opioid abuse and addiction.

Shares of Nektar fell about 10 percent on the Nasdaq following the news, but since then had begun rising again Friday.

In the SEC filing, the company noted that the postponement was not unique to NKTR-181, and that the FDA would continue to review the application for the drug according to the original timeline. Though not named in the filing, painkillers usually fall under the authority of the Anesthetic and Analgesic Drug Products Advisory Committee.

“We are encouraged by the fact that the FDA stated in their general advice letter to us that they intend to continue the review of NKTR-181’s [New Drug Application] according to the existing PDUFA deadline,” wrote Jennifer Ruddock, Nektar’s senior vice president for strategy and corporate affairs, in an emailed statement. “They’ve also communicated that they hope to reschedule the postponed advisory committee meeting and take action before the end of this year.”

The FDA did not respond to a request for comment.

If the agency fails to reach a decision by the Aug. 29 PDUFA date, it will have to pay back some or all of Nektar’s application fees, noted David Gortler, a former FDA official who now does regulatory consulting and teaches pharmacology at Georgetown University.

“I understand that they’re reviewing some policy issues, but if the FDA acts on this responsibly, they should go back to reviewing this drug right away,” Gortler said in a phone interview. A drug that is able to treat pain without the effect of addiction would be something that holds promise for people who are sick, he explained.

Also last week, shares of New York-based Intra-Cellular Therapies fell sharply after the FDA canceled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for Wednesday for the drug lumateperone in schizophrenia. The stated reason was that the meeting had been canceled so that the agency could review new and any forthcoming information regarding the company’s regulatory approval application for the drug. The PDUFA date for lumateperone is Sept. 27, but new information could end up extending the date, the company said.

Photo: FDA, Flickr (free of all copyright for use and redistribution without restriction)

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Former opioid company executives convicted in federal court

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Insys founder John N. Kapoor, center, leaves the John Joseph Moakley United States Courthouse in Boston on May 2, 2019.

Five former executives from one of the companies at the heart of the nationwide opioid epidemic were convicted in federal court Thursday.

A federal jury in the US District Court for the District of Massachusetts found the executives of Insys Therapeutics – founder John Kapoor and executives Richard Simon, Sunrise Lee, Joseph Rowan and Michael Gurry – guilty on RICO conspiracy charges. Two other former executives, Michael Babich and Alec Burlakoff, had previously pleaded guilty. Kapoor was arrested in October 2017, while the others were arrested in December 2016.

According to the indictment, the executives of Chandler, Arizona-based Insys conspired to get doctors in various states, many of whom operated pain clinics, to prescribe Subsys, a fentanyl-based spray, in exchange for bribes and kickbacks. Subsys has Food and Drug Administration approval for breakthrough cancer pain, but the doctors were mostly prescribing the drug off-label for patients who did not have cancer. Although it is legal for doctors to prescribe drugs for any use, as long as it is within the parameters of medical ethics and there is a scientific basis, drugmakers are forbidden from marketing their products for off-label uses.

Insys launched Subsys in March 2012, but the executives quickly became dissatisfied with its sales and, starting in May 2012, devised a plan whereby they used pharmacy data to identify doctors who prescribed a high volume of rapid-onset opioids. They then provided speaker fees, honoraria for marketing events, food and entertainment, administrative support and fees in exchange for the doctors prescribing the drug. Between May 2012 and December 2015, sales of Subsys went from $3.7 million during the first nine months of 2012 to $329.5 million for fiscal year 2015.

The convictions “mark the first successful prosecution of top pharmaceutical executives for crimes related to the illicit marketing and prescribing of opioids,” US Attorney Andrew Lelling said in a statement. “Just as we would street-level drug dealers, we will hold pharmaceutical executives responsible for fueling the opioid epidemic by recklessly and illegally distributing these drugs, especially while conspiring to commit racketeering along the way.”

Other companies blamed for the opioid epidemic have fallen on hard times as well, as lawsuits related to their aggressive marketing of highly addictive opioid painkillers pile up. In March, Reuters reported that Purdue Pharma, the maker of the long-acting oxycodone drug OxyContin, was exploring a Chapter 11 bankruptcy filing as it faced about 2,000 lawsuits related to the drug. In response, the philanthropic efforts of the Sackler family that owns Purdue have come under scrutiny.

Photo: Jonathan Wiggs/The Boston Globe, via Getty Images

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Cigna and VA join forces to help veterans at risk of opioid misuse

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White pharmaceutical pills spilling from prescription bottle over American map

Health insurer Cigna and the Department of Veterans Affairs have partnered in an effort to aid veterans with chronic pain who are also at risk for opioid misuse.

By teaming up, the organizations seek to educate healthcare providers as well as veterans and their families about safe opioid use.

In a statement, Cigna president and CEO David Cordani noted that his organization plans to share its resources and practices to help veterans.

The VA and Cigna also intend to promote existing support resources like the Veterans Crisis Line and Cigna’s Veterans Support Line.

“This partnership is in line with VA’s priorities of transforming our business systems and supporting more robust partnerships with state and local communities,” VA Secretary Robert Wilkie said in a statement. “By partnering with Cigna, we have extended our reach to help improve the way healthcare providers approach opioid use and we demonstrate our commitment to place Veterans’ safety and well-being above all.”

The ultimate aim of the partnership, which was formalized in early March, is to improve opioid use-related patient-provider interactions and boost the delivery of care and health outcomes for veterans.

As the opioid epidemic rages on, other organizations are working to offer solutions to the problem.

At the Health 2.0 conference last fall, startups in the $50,000 Robert Wood Johnson Foundation Opioid Challenge pitched ideas on using tech to support substance abuse treatment. The winner of the competition was Boston-based Sober Grid, which created a platform to help users locate nearby treatment centers. It also offers telehealth capabilities that can connect patients to professional and peer counselors. The startup was founded back in 2015.

Additionally, Blue Shield of California launched a Narcotic Safety Initiative in 2015. Earlier this year, the results of that project showed a 56 percent reduction in overall opioid use among the payer’s members with chronic, non-cancer pain compared to 2014.

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In last Senate testimony, FDA’s Gottlieb highlights agency’s opioid epidemic efforts

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Outgoing Food and Drug Administration Commissioner Scott Gottlieb used his testimony before lawmakers on the FDA’s budget to highlight the agency’s efforts to combat the opioid crisis.

In his testimony, before the Senate Subcommittee on Appropriations, Gottlieb said that the $55 million he is requesting for the FDA to support its work on the crisis, which he said would remain the agency’s highest priority for “many years to come.” The total amount allocated for the FDA in the Trump Administration’s fiscal year 2020 budget is $6.1 billion.

“Today, I want to focus on one of my highest priorities since taking my role two years ago – the FDA’s work to combat the opioid crisis,” Gottlieb said in his remarks. “This is the biggest public health crisis facing the agency and remains one of the biggest crises facing our nation.”

The epidemic has become the subject of numerous lawsuits against companies that aggressively marketed opioid painkillers, often to patients for whom they were not appropriate. In January, a criminal trial against former executives of Insys Therapeutics began. The executives, including founder John Kapoor, were charged with conspiracy to commit racketeering, wire fraud and mail fraud, based on allegations that they used bribery and fraud to persuade doctors to prescribe the drug Subsys – a sublingual spray used to treat breakthrough cancer pain – mostly off-label, for patients who did not have cancers.

More recently, this week OxyContin (oxycodone) manufacturer Purdue Pharma and its founders, the Sackler family, reached a $270 million settlement with the state of Oklahoma that will allow them to avoid a courtroom trial, based on allegations that Purdue drugs contributed to the deaths of thousands of people. Purdue is perhaps the most infamous of opioid manufacturers and is also the subject of numerous other cases filed by federal, state and local governments. It was reported earlier this month that the company was exploring a Chapter 11 bankruptcy filing.

“We’re focused on decreasing exposure and preventing new addiction, supporting the treatment of those with opioid use disorder, promoting development of novel pain treatment therapies and increasing enforcement and carefully assessing benefit-risk of opioids,” Gottlieb said in his remarks.

Gottlieb, who was appointed FDA commissioner in May 2017, announced his resignation on March 5. Norman Sharpless, director of the National Cancer Institute, was named acting commissioner, though others have been suggested to be Gottlieb’s ultimate successor as well.

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Pinpointing patterns in opioid abuse and using data to fight fraud

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As the opioid crisis continues to worsen, claiming the lives of more than 130 people each day in the U.S., the healthcare industry needs to dig deep in order to determine the role that prescription medications play. After all, about 80 percent of people who use heroin first misused prescription opioids.

Currently no one solution exists that can effectively address the entirety of the opioid crisis. It will take unprecedented collaboration across industry stakeholders if we are to manage and slow this epidemic both now and in the future. Big data and analytics can help tackle the challenge by identifying and evaluating entities who contribute to potential risk, or who are themselves at-risk, within the various points of the healthcare ecosystem.

A critical lens that is often missed is the need to analyze data from traditional health sources and combine this information together with non-medical sources of data from public records. Public records provide insights into at-risk entities, behaviors, and connections – offering a unique view of individuals as they engage throughout the healthcare system. Outputs of this risk evaluation provide astounding insights otherwise unavailable when dealing only with healthcare or non-healthcare data separately: they identify social groups and other “networks” of schemers who work together to perpetuate the dangerous cycle of drug availability and abuse. An analysis of each data set by itself is simply not comprehensive enough to reveal the entire spectrum of opioid abuse patterns: lacking the relationship component that drives all diversion tactics.

Relationships and risks
Relationships are the foundation on which our communities are built, driving people’s behaviors, dependencies and, unfortunately, schemes. According to the Centers for Disease Control and Prevention, drug diversion – the transference of legally controlled and prescribed substances from one individual to another – is the number one avenue for opioid abuse. By uncovering relationships, associations, and affiliations among providers, patients, and pharmacies, healthcare stakeholders can identify players who contribute to risks or who are at personal risk of prescription drug abuse and fraud. These individuals may be behaving either intentionally or inadvertently, but nonetheless warrant further evaluation.

Patients, or health plan members, are the most at-risk group in fraudulent schemes and this group includes individuals who are new to taking opioid-type medications, or the opioid naive. Patients who receive multiple opioid prescriptions are also placed at greater risk due to the cumulative effect that these medications have. Other risky patients include those who may be intentionally abusing prescriptions, partaking in recreational drug use, or reselling drugs on the black market.

Prescribers are another source of potential risk due to unknowing, irresponsible, or fraudulent prescribing behaviors. Writing prescriptions to friends and family members is an immediate red flag, as is prescribing excessive quantities of certain drug types across many patients. Physicians may also unknowingly prescribe lower quantities to high-risk patients, ultimately putting these individuals at-risk.

Pharmacies are a third source of potential risk as fraudsters can target them with counterfeit scripts, or, when they lack sufficiently robust patient and provider screening, become targeted as easy-to-fill locations. By serving high volumes of patients who seek a certain type of substances or by filling prescriptions not associated with a corresponding medical condition, pharmacies become inadvertent participants in the propagation of fraudulent schemes.

Uncovering patterns in big data
However, intelligence isn’t lacking on these risk-prone players. There is a massive amount of transactional information about patients, providers, and pharmacies and their respective roles in the opioid epidemic. By analyzing large quantities of prescription data, in combination with public records data, stakeholders have an opportunity to detect which providers are engaged in high-dose script writing, instances where opioids are being prescribed to large social or family groups, and when prescribing has occurred to patients with a high-risk for potential abuse, among others.

Coupled with analytics, this transaction data can also surface situations where a large number of prescription seeking patients for a particular pharmacy originate from a single physician, or even where prescriptions are written without a corresponding doctor or hospital visit. Data can reveal “frequent flyers” or “doctor shoppers,” patients who go to one or multiple providers for high-risk drugs within a short period of time.

Patients seen exhibiting this behavior are likely supporting a drug habit or seeking to divert drugs. Since they typically act quickly and pay with cash, they can be tough to catch without a supporting technology that tracks—and flags—suspicious steps. Proper identity resolution forms the foundation of this process: it is critical to identify the correct individual even when he or she uses an identity variation. For example, many systems will fail to catch that Richard Grape, Ricky Grape, and Rick Grape with slightly altered inputs are all the same person; an error that could result in the receipt of additional prescriptions.

Visualization, an important tool in the big data and analytics arsenal, can help stakeholders quickly see relationships that identify interconnected entities and allows them to focus on the social groups of interest. These networks of entities who work together to drive widespread drug diversion, may exist completely outside of the scope of healthcare data. Relationships may include family members, associates, colleagues, roommates, members of social organizations, joint owners, and businesses that individuals frequent, to name but a few. When public record insights are coupled with healthcare interactions, patterns quickly emerge identifying entities and clusters of potential risk and abuse.

Once these at-risk or high-risk entities are confirmed, healthcare stakeholders can bring these insights together in order to mitigate drug diversion and non-medical opioid use throughout the ecosystems’ various workflows. Consider the value of answering the following questions about a patient within an identified social network:

  • Is she part of a social group whose members are trending toward excessive total Morphine Equivalent Dose (MED) calculations? – Tracking daily patient MED totals can help identify individuals who are potentially at risk for overdose, abuse, or diversion.
  • Is he receiving multiple prescriptions that cause him to exceed the daily safe MED?
  • Is she within the network of a patient receiving the same drug type?
  • Is he receiving prescriptions from a provider within his social network?
  • Is she filling a script from a prescriber that services high-risk patients?
  • Is he receiving multiple prescriptions within a short timeframe?
  • Is she part of an upward trending high-risk social group?

In cases where answers to these questions merit further investigation, it is often determined that the social networks involved are working with pill mills to acquire opioids for non-medical reasons. Pill mill behaviors typically involve providers, clinics, and pharmacies that fill specific high-risk prescriptions frequently and without proper due diligence. Through healthcare claims and public records data, the stakeholders who need access to at-risk or high-risk intelligence can gain significant visibility into the key offenders and potential collateral of excessive prescribing.

It’s important to note that these data insights surface not only knowing participants, but may include prescribers and pharmacies who are inadvertently participating in pill mill activities. These entities can be targeted by large networks of collaborating patients who have organized together to obtain large quantities of appropriately dispensed high-risk drugs. Identifying these instances provides opportunities for education as well as further screening.

Scoring and sharing
As we begin to work together and fight the opioid epidemic, it is critical to identify and evaluate those at-risk and those who are sources of risk, regardless of which doctor, pharmacy, provider, or health plan had identified them first. Each party can benefit from one another’s lessons learned during historical and ongoing interactions. It is only through collaboration that stakeholders can share insights to detect and prevent risk at an industry level.

Imagine a future state in which every healthcare stakeholder would immediately benefit from the collective intelligence of their peers and counterparts, using this information to prevent, detect, and mitigate further behaviors that threaten patient health and industry integrity. By securing and sharing insights, we will not only reduce the unknown risks, but also increase our potential to overcome this crisis.

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Former Insys execs in alleged opioid conspiracy start criminal trial in Boston

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Former executives of a company that allegedly persuaded doctors to needlessly prescribe an opioid medication – and were accused in the process of helping fuel the country’s opioid epidemic – were set to face criminal trial in a Boston federal court Monday.

The case involves former executives of Chandler, Arizona-based Insys Therapeutics, who are charged with conspiracy and conspiracy to commit racketeering, wire fraud and mail fraud. They include founder John Kapoor, regional sales directors Sunrise Lee and Joseph Rowan, national director of sales Richard Simon and vice president of managed markets Michael Gurry. Two other executives, former CEO Michael Babich and vice president of sales Alec Burlakoff, pleaded guilty earlier this month and in November, respectively, and are cooperating with prosecutors.

All but Kapoor were arrested in December 2016 and charged with allegedly conspiring to get doctors in various states, many of whom operated pain clinics, to to prescribe the drug, Subsys, in exchange for bribes and kickbacks, mostly for patients who did not have cancer. Kapoor was arrested and added to the indictment in October 2017.

Subsys is a sublingual spray used to treat breakthrough cancer pain that the company launched in March 2012. The drug carries risks similar to those of other opioids, especially fentanyl-based products, some of which can be life-threatening, according to its label.

According to the indictment, the executives became dissatisfied with Subsys’s sales performance and, starting in May 2012, allegedly devised their plan to use bribery and fraud to induce doctors to prescribe the drug. The bribery and kickbacks included speaker fees and honoraria for marketing events, food and entertainment, administrative support and fees paid to pharmacies that were also involved, according to the indictment.

During the period of the alleged conspiracy, which lasted through December 2015, sales of Subsys went from $3.7 million during the first nine months of 2012 to $329.5 million for fiscal year 2015, according to Insys Securities and Exchange Commission filings. In July 2015, the company’s stock price peaked at $44.92. As of Monday, it was trading at $3.65 per share.

At the time of their arrests, the executives were accused of helping to fuel the nationwide problem of overprescribing and overuse of opioid painkillers. “These Insys executives allegedly fueled the opioid epidemic by paying doctors to needlessly prescribe an extremely dangerous and addictive form of fentanyl,” Phillip Coyne, a special agent with the Department of Health and Human Services’ Office of Inspector General, said in a statement related to Kapoor’s October 2017 arrest.

Photo: fstop123, Getty Images

 

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