60 Arrested in Latest Crackdown on Rx Opioids

By Pat Anson, PNN Editor

Sixty people in five states face charges of illegal opioid prescribing and healthcare fraud in the latest federal crackdown on opioids. The arrests are the first since the Justice Department established an opioid strike force last year to concentrate on drug crimes in the Appalachian region.

The defendents include 31 doctors, 7 pharmacists, 8 nurse practitioners and 7 other licensed medical professionals.

“The opioid epidemic is the deadliest drug crisis in American history, and Appalachia has suffered the consequences more than perhaps any other region,” Attorney General William Barr said in a statement. 

“But the Department of Justice is doing its part to help end this crisis. One of the Department's most promising new initiatives is the Criminal Division's Appalachian Regional Prescription Opioid Strike Force, which began its work in December.  Just four months later, this team of federal agents and 14 prosecutors has charged 60 defendants for alleged crimes related to millions of prescription opioids.” 

The charges involve over 350,000 opioid prescriptions and over 32 million pills. A federal prosecutor claimed that was the equivalent of a dose of opioids for every man, woman and child in Ohio, Kentucky, Tennessee, West Virginia and Alabama.

In one case, a doctor and several pharmacists are accused of operating a pill mill in Dayton, Ohio. Over a two-year period, the pharmacy dispensed over 1.75 million pills. 

In Kentucky, a doctor operating a pain management clinic allegedly provided pre-signed, blank prescriptions to office staff who then used them to prescribe controlled substances when he was out of the office. 

And in Tennessee, a doctor who called himself the “Rock Doc” allegedly prescribed dangerous combinations of opioids and benzodiazepines, sometimes in exchange for sexual favors.

“Reducing the illicit supply of opioids is a crucial element of President Trump’s plan to end this public health crisis,” Health and Human Services Secretary Alex Azar said in a statement.  “It is also vital that Americans struggling with addiction have access to treatment and that patients who need pain treatment do not see their care disrupted, which is why federal and local public health authorities have coordinated to ensure these needs are met in the wake of this enforcement operation.”

A DOJ press release provided a list of hotlines, websites and other resources where effected patients can get addiction treatment. None of them, however, appear to offer pain management.

Pain patients are often the forgotten victims in law enforcement crackdowns on healthcare providers. Dawn Anderson, for example, a double amputee and diabetic, died last month in “sheer agony” because she was no longer able to get opioid medication from a pain management doctor who stopped practicing medicine after he was accused and convicted of healthcare fraud.    

Most Overdoses Don’t Involve Rx Opioids

The Appalachian region – and West Virginia in particular – has been ground zero in the opioid crisis. But a new study by researchers at West Virginia University shows just how much the crisis has shifted away from prescription opioids.

Researchers analyzed over 8,800 drug-related deaths in West Virginia from 2005 to 2017 and found that deaths involving fentanyl soared by 1,325% over that period.

From 2005 to 2014, prescription opioids were involved in almost 60% of drug related deaths in West Virginia, but from 2015 to 2017 they were only involved in about 30% of drug deaths.

West Virginians are now twice as likely to die from fentanyl than they are from oxycodone. Deaths linked to fentanyl, heroin, alcohol, alprazolam (Xanax) and cocaine outnumber those from oxycodone or any other opioid pain reliever.

Fentanyl and its analogs are synthetic opioids 50-100 stronger than morphine. They’ve become a scourge on the black market, where they are frequently mixed with heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

Reducing the supply of prescription opioids and locking up doctors isn’t going to solve the fentanyl problem.

"One of the proven ways to reduce overdoses is to decrease the number of people who are addicted and using. But with fentanyl, you could halve the number of addicts in West Virginia, and the overdose rate could still go up because the strength of the drug coming in is so much stronger and can vary widely from one day to the next," said Gordon Smith, MD, an epidemiologist in the West Virginia School of Public Health. "This is an absolute quandary."

West Virginia's increase in fentanyl-related deaths is part of a national trend. As the CDC reported, deaths from fentanyl overdoses spiked across the United States in 2015 and are still climbing. West Virginia leads the nation in fentanyl-related deaths and has the highest per capita rate of overdose deaths overall.

Former Insys Executives Arrested for Bribing Doctors

By Pat Anson, Editor

The former CEO of Insys Therapeutics and five other former company executives have been arrested on federal charges of racketeering and bribing doctors to prescribe a potent painkiller off-label.

The arrests culminate a lengthy investigation into the Arizona drug maker, which has been accused of sordid sales practices that led to the overdose deaths of hundreds of pain patients.  

The fentanyl-based painkiller, called Subsys, has FDA approval for breakthrough cancer pain. The Insys executives allegedly bribed and gave kickbacks to doctors to prescribe the oral spray off-label for patients suffering from conditions such as joint pain and post-traumatic stress disorder.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

“Patient safety is paramount and prescriptions for these highly addictive drugs, especially fentanyl, which is among the most potent and addictive opioids, should be prescribed without the influence of corporate money,” U.S. Attorney Carmen Ortiz said in a statement. 

Former CEO Michael Babich and the other Insys executives are also charged with misleading and defrauding insurance companies that were reluctant to approve payments for Subsys when it was prescribed for non-cancer patients. The company created a special “reimbursement unit” that was dedicated to obtaining prior authorization from insurers, often by falsely claiming they were for patients with medically urgent cancer diagnoses.

“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression,” said Harold Shaw, Special Agent in Charge of the FBI’s Boston Field Division.  “In doing so, they contributed to the growing opioid epidemic and placed profit before patient safety."

The Southern Investigative Reporting Foundation released a report last year, headlined “Murder Incorporated,”  that blamed aggressive sales practices at Insys for the overdose deaths of hundreds of pain patients.  CNBC also accused the company of “putting profits before patients as it makes millions off your pain.”

In June, federal agents arrested two Insys sales representatives for bribing doctors to prescribe Subsys. Some physicians were wined and dined at upscale restaurants in New York City, while others were taken to private tables at a strip club and given free drinks. According to the indictment, the salesmen were instructed to "expect and demand" that doctors hired by Insys to speak at promotional events prescribe "large quantities" of Subsys. The doctors obliged, prescribing over $5 million worth of Subsys in 2014, much of it billed to private insurers or Medicare.

Doctors are allowed to prescribe drugs for conditions not approved by the FDA, a practice known as off-label prescribing, but drug makers are not permitted to market or promote medications for off-label use.

According to Open Payments, a government website that tracks industry payments to doctors, Insys paid over $6 million to nearly 7,800 doctors last year for food, beverages, travel, lodging and speaker fees. The payments were 30 times more than what the company reported spending on research.

Subsys is a lucrative product for Insys and its biggest moneymaker. According to the Healthcare Bluebook, 30 spray bottles of Subsys currently cost about $5,600.