Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales

Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales | Pharmaguy's Insights Into Drug Industry News | Scoop.it

You can't make this stuff up!

According to Huffington Post, "Pharmaceutical sales representatives selling an opioid-based drug 50 times more powerful than heroin filmed a company-made rap video in which they danced with a giant bottle of their deadly fentanyl spray, a federal grand jury alleged in an indictment unsealed this week (for more about that, read "Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!").

"The grand jury alleged that 'prominent' sales reps at Insys Therapeutics Inc. appeared in a 2015 music video that used a song by rapper A$AP Rocky, which was played at the company’s national sales meeting that year...Court documents didn’t say which A$AP Rocky song was used in the video, but the indictment documents strongly suggested it could be the 2012 song “Fuckin’ Problems."

Pharma Guy's insight:

The video ended with the company’s vice president of sales removing the Fentanyl Spray costume, revealing his identity. The vice president of sales, Alec Burlakoff, was previously indicted back in December. Burlakoff has been accused of trying to boost drug sales by controversial means before.

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Fueling the Opioid Epidemic: A “Key Strategic Imperative” for Insys #Pharma

Fueling the Opioid Epidemic: A “Key Strategic Imperative” for Insys #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In early 2015, an Insys Therapeutics employee called an insurer and provided misleading patient information in order to win clearance for a prescription for its Subsys painkiller. The conversation — in which the employee pretended to call from a physician’s office — was about a woman named Sarah Fuller, whose family later claimed she died because she was inappropriately prescribed the drug.

 

The phone call was made scarcely a year after a consultant warned the drug maker that it lacked needed policies for governing such activities, but Insys executives failed to take corrective action, according to U.S. Sen. Claire McCaskill (D-Mo.), who released a copy of the consultant’s report and a recording of the phone call as part of an ongoing investigation into the opioid crisis (see report here: http://freepdfhosting.com/5deb5ac1db.pdf).

 

The details of both the phone call and the report help flesh out what is already a disturbing picture of unchecked pharmaceutical marketing that has emerged from a growing raft of documents in criminal cases and civil lawsuits involving the beleaguered drug maker. And the report arrives as opioid makers, in general, are accused of deliberately downplaying risks and improperly encouraging prescribing.

 

To boost prescriptions for Subsys, which contains the highly addictive fentanyl opioid, Insys allegedly employed numerous tactics. These included a familiar page from the pharmaceutical playbook in which some physicians were rewarded with speaking fees and other forms of compensation for writing outsized numbers of prescriptions, according to court documents.

 

Central to the Insys marketing plan, however, was a so-called reimbursement center, which was created specifically to contact insurers and persuade them to authorize prescriptions. In the health insurance world, prior authorization is an extra step that insurers use to weed out unnecessary prescribing. Often, this proves to be a challenging hurdle, especially when a medicine is pricey.

 

But Insys created this “center” because many insurers and pharmacy benefits managers often declined to green-light prescriptions that were not for breakthrough cancer pain patients. Authorities say the company sought to widen the market for its drug by illegally inducing doctors to prescribe the pill for other sorts of pain. This is known as “off-label” prescribing, which doctors are permitted to do.

 

An Insys spokeswoman did not respond to a request for comment.

 

Further Reading:

Pharma Guy's insight:

A smoking gun if ever I saw one!

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DEA Approves FDA-Approved Insys Synthetic Marijuana

DEA Approves FDA-Approved Insys Synthetic Marijuana | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Insys Therapeutics, a pharmaceutical company that was one of the chief financial backers of the opposition to marijuana legalization in Arizona last year received preliminary approval from the Drug Enforcement Administration this week for Syndros, a synthetic marijuana drug.

 

Insys gave $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona year (read “Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign”; http://sco.lt/4vyNdJ). The donation amounted to roughly 10 percent of all money raised by the group in an ultimately successful campaign against legalization. Insys was the only pharmaceutical company known to be giving money to oppose legalization last year, according to a Washington Post analysis of campaign finance records.

 

Syndros is a synthetic formulation of THC, the main psychoactive component in the cannabis plant. It was approved by the FDA last summer to treat nausea, vomiting and weight loss in cancer and AIDS patients. The DEA approval places Syndros and its generic formulations in Schedule II of the Controlled Substances Act, indicating a "high potential for abuse." Other Schedule II drugs include cocaine, morphine and many prescription painkillers.

 

"It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets," a spokesman for Arizona's marijuana legalization campaign said of Insys last year.

 

Insys is also the subject of numerous state and federal criminal investigations, as well as a shareholder lawsuit, over its aggressive marketing of a product containing the potent and deadly opioid painkiller fentanyl. In December, the FBI arrested the company's former chief executive and five other executives on charges that they "paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression." [See http://sco.lt/5f8yLx]

 

In addition to its synthetic marijuana products, Insys is also developing a drug to treat opioid overdose.

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DUIPs (Docs Under the Influence of #Pharma) Prescribe Opioids - Sales Reps Arrested

DUIPs (Docs Under the Influence of #Pharma) Prescribe Opioids - Sales Reps Arrested | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The former district manager at Insys Therapeutics was irate. Several doctors were not prescribing enough of the company’s Subsys painkiller, which contains fentanyl, a powerful and addictive opioid.

 

So the manager, Jonathan Roper, wrote his sales team a pointed email, saying that “we invest a lot of time, money, blood, sweat, and tears on ‘our guys,’ ” — a reference to doctors who were paid to speak to other physicians about the medicine. “We hire only the best of the best to be a part of our speaker bureau and dropping script counts is what we get in return? This is a slap in the face to all of you and is a good indication as to why NONE of you are climbing in the rankings this quarter.”

 

Last Thursday, Roper and a former Insys sales rep named Fernando Serrano were arrested and charged with violating federal kickback laws. They allegedly ran a scheme between October 2013 and June 2015 in which doctors were paid thousands of dollars to participate in “sham educational programs” designed to boost Subsys prescriptions, according to Preet Bharara, the federal attorney for New York. The email from Roper two years ago was part of the indictment.

 

The arrests come amid intensifying controversy over the abuse and misuse of prescription painkillers and the extent to which these are appropriately prescribed. Federal health officials recently released new guidelines urging doctors to restrict their prescribing and some lawmakers want to pressure the Chinese government to toughen its laws to stop the illicit export to the United States.

 

This is not the first time that Insys has been named in connection with illegal activities designed to boost prescriptions for Subsys, which was approved in 2012 to treat cancer pain and generated nearly $330 million in sales last year (see here).

 

For instance, the company arranged “social gatherings at high-end restaurants in Manhattan” that were supposed to involve teaching doctors about Subsys but did not really involve any education. Doctors were enlisted to speak at these events, but often “lacked an appropriate audience of health care professionals,” according to the indictment. To make them appear legitimate, sign-in sheets were sometimes forged by adding names of doctors who did not attend.

 

Serrano and other reps received bonuses based, in large part, on the volume of Subsys prescriptions written by the doctors they were assigned to work with, according to the indictment. Serrano received a $70,000 bonus in the first quarter of 2014, which was the eighth-largest bonus among Insys reps at the time. In the fourth quarter of 2013, his bonus was about $100,000, the fifth-largest among Insys reps.

Pharma Guy's insight:

Is it any wonder that “Pharma Speaker Dinners are Popular with Docs”?; http://sco.lt/5dsmjR 

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Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!

Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The founder of Insys Therapeutics Inc. was arrested Thursday and charged with allegedly bribing doctors to improperly prescribe Insys drugs containing the powerful opiate Fentanyl — the biggest arrest in a nationwide crackdown that’s already netted two convictions in Mobile.

 

John N. Kapoor, 74, was arrested in his home state of Arizona Thursday and charged with RICO conspiracy as well as other felonies including conspiracy to commit mail and wire fraud and conspiracy to violate the Anti-Kickback Law. To date, Kapoor is the most prominent pharmaceutical executive to be charged in any drug conspiracy.

 

John Kapoor, billionaire founder of pharmaceutical company Insys Therapeutics, was arrested and charged with leading a drug conspiracy on Oct. 26, 2017. (insysrx.com)

Kapoor, the former Executive Chairman of the Board and CEO of Insys, founded the company in the late 1990s.

He resigned after six former Insys executive board members were indicted in December 2016, though he has remained an active boardmember and majority owner of the company.

 

The month after those indictments, the Department of Justice turned its attention to Mobile, where Dr. John Patrick Couch and Dr. Xiulu Ruan — owners and operators of Physicians Pain Specialists of Alabama — were being tried on many of the same charges Kapoor himself now faces.

 

After a seven-week trial, Ruan and Couch became the first medical professionals in U.S. history to be convicted on federal RICO charges that were originally intended to combat organized crime. They were each sentenced to at least 20 years in federal prison, and the federal government has since seized millions of dollars in cash, cars and property from both.

 

What ties the two local pain docs to Kapoor are the drugs that his company produced and marketed, most notably the fentanyl-based product Subsys. Intended and FDA approved to treat “breakthrough pain in Cancer patients,” Ruan and Couch were accused of prescribing the drug to non-cancer patients without a legitimate medical purpose.

 

Further Reading:

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Former Insys Sales Reps Bribed Docs To Prescribe Opioids To As Many Patients as Possible

Former Insys Sales Reps Bribed Docs To Prescribe Opioids To As Many Patients as Possible | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Two former sales reps pleaded guilty on Tuesday to bribing doctors in exchange for prescribing the powerful Subsys painkiller sold by Insys Therapeutics, which is under numerous investigations by state and federal authorities for its role in the opioid epidemic.

In both instances, the sales reps pleaded guilty to violating the federal anti-kickback law for participating in a speaker program that prosecutors say was used to reward doctors and other medical practitioners for prescribing Subsys, which contains fentanyl and carries a high risk of dependency.

Insys claimed its speaker program was designed to educate medical providers about its drug. But federal authorities maintained the primary purpose was to induce doctors to write prescriptions for as many patients as possible. The drug was approved only to treat people suffering breakthrough cancer pain.

 

Further Reading:

 

  • “Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign”; http://sco.lt/4vyNdJ
Pharma Guy's insight:

Insys is a "bad player" in the opioid market!

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Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign

Insys, Maker of a Fentanyl Opioid Spray, Donates $500K to Anti-Marijuana Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Insys Therapeutics has donated $500,000 to an anti-legalization of marijuana campaign in Arizona known as Proposition 205. Pro-legalization advocates view the half million dollar donation as a further attempt to line the pockets of powerful drug corporations with profits by making it near-impossible for marijuana manufacturers to compete. Insys Therapeutics is a pharmaceutical company responsible for the production of a controversial oral fentanyl spray marketed as Subsys. Fentanyl is a highly addictive, extraordinarily powerful opiate typically used to sedate patients who are undergoing major surgery. The drug is 50 times more potent than morphine. It’s also the same drug responsible for the deaths of Michael Jackson and more recently, Prince. With the ever-growing opioid epidemic in the country, I ask: What could possibly justify a prescription oral spray of such an incredibly risky drug for the treatment of pain when marijuana can effectively (and safely) do the same for far less money?

Insys Therapeutics claims their donation was made out of concern over the safety of marijuana, stating their primary goal is to protect society’s overall health and well-being. That’s pretty interesting considering the company itself is currently under state and federal investigation in relation to its marketing tactics. Six states have already investigated the company’s sales practices, with the state of Illinois having sued Insys in August of 2016 for allegedly promoting the drug to doctors for uses other than those approved by the Food and Drug Administration (FDA). It’s also interesting to note the company is developing its own form of synthetic cannabis; one they say will improve upon a similar drug they used to manufacture which has since been discontinued. It seems quite obvious the company is not too concerned over the safety of cannabis itself but rather, anyone else making a profit from it but them. Their donation is one of the largest ever made to an anti-legalization campaign.

Pharma Guy's insight:

A former sales manager for Insys Pharmaceuticals, which manufactures a highly addictive painkiller (Sunsys Fentanyl - 100X more powerful than morphine) and is under investigation in multiple U.S. states, has pleaded guilty to charges of fraud: http://sco.lt/5f8yLx 

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Wow! #Pharma Sales Rep & Paid Physician Paramour‎ Hatch Pain Med Kickback Scheme

Wow! #Pharma Sales Rep & Paid Physician Paramour‎ Hatch Pain Med Kickback Scheme | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A former sales manager for Insys Pharmaceuticals, which manufactures a highly addictive painkiller (Sunsys Fentanyl - 100X more powerful than morphine) and is under investigation in multiple U.S. states, has pleaded guilty to charges of fraud.


Former Insys sales manager Natalie Reed Perhacs recently pleaded guilty to conspiracy to commit health care fraud including engaging in kickback schemes in the United States District Court for the Southern District of Alabama (Southern Division). 


Insys was the subject of a CNBC investigation in November which revealed that two physicians in Mobile, Alabama, Dr. Xiulu Ruan and Dr. John Couch, partners at a practice, received over $210,000 from Insys Therapuetics in 2013 and 2014 for things like speaking fees, travel and meals.


The agreement with the Insys sales rep, filed on Feb. 17 and obtained by CNBC, states that Perhacs was hired by Insys as a kickback to Dr. Ruan, who became fond of her and "went out of his way" to try to get her hired as a sales representative with a pharmaceutical company. 


In an e-mail sent on November 7, 2012, Dr. Ruan asked Perhacs,"Well, I want to ask you a personal question and hopefully you would not be offended. Are you involved with someone now? . . . You don't have to answer any of these if you do not feel comfortable."


The plea agreement states that Perhacs was not hired because of her knowledge or experience working with controlled substances like Subsys; but rather, she was hired to "induce, and in exchange for, Dr. Ruan continuing to prescribe Subsys."


"Perhacs had a strong financial incentive to do so, and to turn a blind eye to illegal kickbacks being paid by Company A [Insys] to Dr. Ruan and Dr. Couch. Despite earning a base salary of only $40,000.00 per year, commissions from off-label prescriptions written by Dr. Ruan and Dr. Couch resulted in Perhacs making over $700,000.00 between April 2013 and the doctors' arrests on May 20,2015."

Pharma Guy's insight:

Of course, this is not typical of mainstream Big Pharma.

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