New Hampshire and the Feds are going after opioid manufacturers with a vengeance.
NH State law enforcement has reached a $3.2 million settlement with fentanyl drug manufacturer Insys and is pursuing investigations against Purdue Pharma, Actavis Pharma, Janssen Pharmaceuticals and Teva Pharmaceuticals.
The FBI indicted six senior Insys executives last month on charges of racketeering.
And actions have been taken against the company’s sales force and/or prescribers in several other states as well.
Insys’ Subsys fentanyl drug was narrowly approved by the FDA for breakthrough cancer pain. In what has become an only-too-successful marketing strategy, allegedly Insys aggressively promoted Subsys for non-cancer treatment purposes. Reports indicate only 1 percent of Subsys scripts in New Hampshire were written by cancer doctors.
The Granite State has the highest death rate from fentanyl overdose in the nation.
A Physicians’ Assistant in New Hampshire was allegedly paid speaking fees as a backdoor way of incentivizing him to prescribe Insys’ Subsys(r) a version of opioid fentanyl.
Reports indicate of the 100,000 doses consumed in NH, this one PA, Christopher Clough, prescribed 84% of them.
What happened in New Hampshire is directly related to Insys’ marketing practices. Make no mistake, this was all about profits, regardless of the damage to patients, families, society, kids.
This from the NYTimes:
“As Subsys grows more mature, we expect the number of experienced patients to grow,” Michael E. Faerm, an analyst for Wells Fargo, wrote last year in a note to investors. “As the experienced patients titrate higher, the average dose per prescription should increase.”
The former Insys sales representatives said they were paid more for selling higher doses…
What a great business. A highly addictive drug creates more revenue for the manufacturer and for sales reps as patients need more and more and more to get “relief” – or get high.
New Hampshire has subpoenaed other large opioid manufacturers who have refused to comply with the demand to provide materials. It’s highly likely Purdue, Teva et al will be compelled to comply when higher courts rule.
What does this mean for you?
A bittersweet moment indeed, but at long last corporate crooks are being criminally charged for their actions that killed people to create profits.
Here’s hoping they are convicted and sentenced to long terms at awful places.
Joe could not agree more with your last statement; however history shows us that white collar drug criminals are not viewed with amount of disdain street pushers are. When are we going to wake up and realize that when you victimize individuals you are a criminal whether you do it face to face or behind closed doors in corporate headquarters. You should be treated the same because the effect on the victim is the same.
I only hope that all these dollars that the Feds are going to be collecting go into drug detox and rehabilitation for all the addicts these corporations created.
Finally!! Corporate greed by these pharmaceutical companies, like war is leaving millions dead, and those that survive will never be the same. These ‘pushers’ should have to sit behind bars and hear the stories from all the friends and families that have lost loved ones due to their need to have more and more money. All their profits and goods should be sold to fund the rehab clinics and for the children being raised in foster care since their parents are dead or unable to care for them due to their addictions.
And if the authorities don’t treat them all like the criminals they are, then shame on our justice system!
Congratulations ! Like most Insys reports, you have recited their recent history. It\’s old news and it\’s been done. We have seen, and heard, all the shocked politicians, and outraged regulators. demanding justice, mourning the dead and vowing change. And the press just keeps following the shiny objects that Insys dangles..
You think any justice was served with this meager fine? Don\’t insult my intelligence. I can do math. So for fun lets figure this out. Your article cites the sale of 100,000 doses of Subsys. Current price (with a coupon) on Good Rx is $277.00/per 200 mcg dose. so, multiply $277 X 100,000. That\’s $27 million and change. But you taught them a lesson with your $3.2 million fine. OH PLEASE! It\’ a tiny fraction of their profits from one doctor\’s prescriptions in your state.
The outraged , FDA, just approved 4 new clinical trials, sponsored by Insys, looking for new indications for guess what??? SUBSYS . That\’s right folks, the company that over the past 3 years, (give or take) has unleashed misery and death on an unprecedented scale nationwide, is now conducting clinical trials to do it all again…legally. It\’s all in the public record at Clinical Trials .gov. These are amazing(ly) ,no cunningly is the word, designed trials that don\’t even meet any real scientific or ethical standard. My personal favorite is the one enrolling 45 patients undergoing bunionectomy (foot) surgery. It poses the totally relevant medical question, \”Which will relieve your post- op (foot) pain better, the most potent rapid onset opioid on the planet, (Subsys) or saline (nothing, nada, \”placebo\”) I wonder how that\’s going to turn out? We won\’t have to wait long, as the FDA appears to be ready to \’fast-track\” the project. If you don\’t need foot surgery, don\’t fret, other trials are looking at Subsys for ER pain. Which not to put too fine a point on this, is not an actual diagnosis. But, hey, the FDA is OK with all of this.
So call me crazy, but I don\’t think this settlement represents anything other than a wink and a nod of tacit approval of Insys \’s previous and future promotion of a lethal drug. Basically, you folks in NH have been sold out and frankly, your lives went pretty cheap. You OK with that ?
Totally agree. Until some CEOs start doing jail time things won’t change.
Oh, and nothing was mentioned about the physician that was supervising the physician assistant and cosigning the charts! In the end the FDA is going to have to step in and make some decisions regarding medication use and label these dangerous medications to be used only in end stage of life pain management. As it stands I am already seeing physicians running for the hills when it comes to managing pain so the pendulum is starting to swing and unfortunately many folks will suffer from inadequate pain management and many addicts will be discharged and will have to seek their own detox and rehab or use illegal drugs. On average it takes a heroin addict about 4 stints in rehab to get clean. We have a lot of work to do to clean up this mess.
I agree with your comments regarding the prescribers role. It’s interesting to note the different approaches being taken in various states. NJ, for example, is almost totally focused on identification, and disciplining, errant practitioners. They are also looking for victims, although what, if any help, is being offered to them is not clear. Statistics vary according to the source, however, only 20% of opioid addicts ever fully recover. The average lifespan of an opioid addict is about 10 years from their onset of use. Given these exceedingly grim statistics, I’m much less concerned with patient’s unmet pain management needs, than I am the devastation awaiting them on the “poppy seed” highway.
(Not to suggest that the constipated, but otherwise completely normal functioning, chronic opioid users, as depicted in TV commercials, are in any way a cynical example of deadly misinformation)
Yes, there is a “big mess” to clean, and it starts when we stop pretending that opioids have a legitimate role in the management of chronic non-cancer pain.
Hi Roberta – just wanted to thank you for your insightful comments. Appreciate your perspective and focus on this.
Joe
I thank-you for helping keep this important story alive. I have both personal and professional experiences, both of which inform my views, and motivate my efforts to help raise public awareness.
Like any complex problem, the opioid crisis does not lend itself to quick answers or easy 1 – 2 step solutions. Given that, we should at least be able to get a handle on corporate greed, and remove it from the equation.