J&J ordered to Pay $572M by Oklahoma judge, implying J&J is a "pusher" of drugs...

[45dotACP]

It is absolutely everywhere, bud, not just academia. We're a 13 physician specialty dept in a multi-specialty high level community / hub hospital, and I am one of only four docs who have resisted to have a mid-level "assigned". I am slowly losing this battle too. Our central admin is making us getting certain new things provisional on our "appropriate" utilization of midlevels.

No matter how much I enjoy the intellectual part of the job, at this point I tell pre-med kids that if you're not going into the procedural / operative / imaging specialty, you will not be in a strong competitive position asking for the salary that buys them 2-4 midlevels.

Additionally, the process for becoming a mid-level (in my opinion) needs stricter standards.

Lots of people just go straight from undergrad to a PA or NP program and as cool as clinicals are and all, those people will have nothing on someone whose done a residency+fellowship or, in the case of a mid-level, worked at the bedside for several years, expanding their critical thinking and knowledge base. Book smarts are important, but thinking they'll prepare you for the big bad world is like thinking having firearms training will help you if you never carry a gun.

CRNAs are required to have two years in critical care before even applying to that program, but I went to school with nurses who went straight from undergrad to NP, or went back to school with maybe a year of experience. Not good.

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[Nephrology]

It is absolutely everywhere, bud, not just academia. We're a 13 physician specialty dept in a multi-specialty high level community / hub hospital, and I am one of only four docs who have resisted to have a mid-level "assigned". I am slowly losing this battle too. Our central admin is making us getting certain new things provisional on our "appropriate" utilization of midlevels.

No matter how much I enjoy the intellectual part of the job, at this point I tell pre-med kids that if you're not going into the procedural / operative / imaging specialty, you will not be in a strong competitive position asking for the salary that buys them 2-4 midlevels.

Oh yeah, by no means did I mean to suggest it was limited to academic medical centers. From what I know, midlevels are also making inroads into surgical fields, particularly in smaller shops. It's definitely something I have considered in the context of specialty selection/career trajectory.

Additionally, the process for becoming a mid-level (in my opinion) needs stricter standards.

Lots of people just go straight from undergrad to a PA or NP program and as cool as clinicals are and all, those people will have nothing on someone whose done a residency+fellowship or, in the case of a mid-level, worked at the bedside for several years, expanding their critical thinking and knowledge base. Book smarts are important, but thinking they'll prepare you for the big bad world is like thinking having firearms training will help you if you never carry a gun.

CRNAs are required to have two years in critical care before even applying to that program, but I went to school with nurses who went straight from undergrad to NP, or went back to school with maybe a year of experience. Not good.

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I think midlevels have an important place in healthcare given the sheer volume of demand, but I have occasionally been really stunned by some of the things I have witnessed them say/do. Not the least of which is what happened with my own care. Long story short, it's clear that the NP who was managing me did not put more than 2 seconds of thought into my chart.

Admittedly, I am a pretty 'boring' patient, but they missed 3 years of elevated BGLs (drawn quarterly). Three years. Would have continued to go unnoticed if I hadn't been digging in my own chart and noticed myself.

[Foxy Brown]

No, sue drug makers for intentionally marketing and encouraging the use of drugs in a way they knew would lead to higher addiction rates. Not even close to "make and market prescription drugs". I know .gov is always the bad guy and the company is always the good guy in the conservative world but go take a look at previous law suits and settlements to see what the angels at the poor drug companies were doing. Intentionally recommending dose amounts and schedules that would cause a small window of withdrawal each day, for example. They intentionally made it harder to get off the drugs, and everyone else is paying for their decision to do so via the fucking mess the opiode crisis has made. They should be held accountable and pay for some of the mess they made.

As someone who has/had a solid career in the pharmaceutical world, I can say this: pharma companies cannot market their products for something for which they have no clinical data to back it up (clinical meaning human trials). Dosages and medication schedules are not created to intentionally cause a "...small window of withdrawal...." Patient safety is the highest priority in clinical studies where efficacy and doses are tested and validated. While I'm not a physician, I can suggest that the minds of the clinical researchers/physicians find it significantly safer to expose a patient to a small window of withdrawal symptoms than it is to overdose a patient. Dosages and schedules are not developed to cause or create addiction - addiction is simple human nature at work. Furthermore, if these companies really did mis-market their products, the FDA would be all over that with Warning Letters, 483s, consent decrees, and if necessary, injunctions. (Ask Novartis how the injunction worked out for them....). Given the publicity of this lawsuit, not hearing of any concurrent FDA involvement tells me the company/companies have acted responsibly as far as pharmaceutical manufacturers/developers.

[Spartan1980]

Sooo... Back to the O/P.

Oklahoma AG's are notorious for shaking down big corporate. Don't matter which letter they have next to their name, they're all the same.

My dad took opiates for extreme back pain for years. His condition needed surgery from the back and the front and his heart conditions precluded that. His surgeon told him "yeah, I can do it, but with all you got going on with the rest, it's about a 12 hour surgery, I don't think you'd survive the surgery". He had coronary heart disease and all that was associated with that plus was on two different arrhythmia drugs since he almost died from that on two separate occasions. He didn't abuse them unless you count his couple of scotch cocktails at the end of the day. He was sober, coherent and able to work every day. He worked the day he died of a heart attack as a matter of fact. He wasn't addicted, he took them as needed and as prescribed when he did take them. Funny how that works.

Our previous AG shook down the poultry farming industry. They were polluting the Illinois river. I'm not going to say that they didn't have an impact, it's pretty common knowledge they had a big impact on that scenic waterway and it wasn't a good one. But the odd thing is, that as far as I can recall, every company he went after was in compliance with state DEQ rules and regs and also in compliance with the EPA. Several of them were actually doing MORE than was required for compliance. They asked him when he was threatening grandstanding to come to the table and tell them what they could do. He said "see you in court". He then drug them into court and shook them down for millions.

This opiate case is no different. They don't want to fix problems, if they did they could have lobbied the legislature to address it which would be the correct way. But if they did that, they wouldn't be able to tout the billions that they brought to the state when they run for higher office.

[BehindBlueI's]

As someone who has/had a solid career in the pharmaceutical world, I can say this: pharma companies cannot market their products for something for which they have no clinical data to back it up (clinical meaning human trials).

They can't market them in that fashion legally, you mean. My wife was a pharmacist. I'm not ignorant to the pharma reps "hinting" at off label uses or how they are compensated. I'm also not ignorant to the multitude of legal settlements by companies that have done exactly that.

And, yes, the makers of Oxycontin did intentionally create windows of withdrawal. They had plentiful internal documentation that 12 hour dosing was often insufficient, yet they had marketed it as a 12-hour drug and feared the effect on profits if they deviated from that. The information is not secret and is not new, and is why they paid out.

https://en.wikipedia.org/wiki/List_o...al_settlements for those who might question if this does, in fact, happen.

Dosages and medication schedules are not created to intentionally cause a "...small window of withdrawal...."

https://www.latimes.com/projects/oxycontin-part1/

Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.

The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.

When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to “refocus” physicians on 12-hour dosing. Anything shorter “needs to be nipped in the bud. NOW!!” one manager wrote to her staff.

Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.

Etc.

[willie]

Since doctors must write these prescriptions, I fail to comprehend why drug companies are being sued unless they are producing tons of this stuff that are diverted. Federal and state governments for at least 100 years have permitted pain clinics staffed by licensed medical doctors to write untold millions of prescriptions for opioids. Ditto for other physicians and dentists.These prescriptions were filled in licensed drug stores staffed by licensed pharmacists. Hence we have government licensed professionals providing these drugs according to laws approved by the federal government and the governments of the 50 states. If doctors don't write the scripts, then patients don't get the pills. I do agree that drug companies are not faultless. However, I see them as rich and easy targets. But, let's sue everybody and spread the blame around.

[scjbash]

They can't market them in that fashion legally, you mean. My wife was a pharmacist. I'm not ignorant to the pharma reps "hinting" at off label uses or how they are compensated.

I know a rep. He's flat out admitted that his job is to push the writing of prescriptions that will make the company (and him) the most money, not the prescriptions that will work the best for the patients.

Since doctors must write these prescriptions, I fail to comprehend why drug companies are being sued unless they are producing tons of this stuff that are diverted. Federal and state governments for at least 100 years have permitted pain clinics staffed by licensed medical doctors to write untold millions of prescriptions for opioids. Ditto for other physicians and dentists.These prescriptions were filled in licensed drug stores staffed by licensed pharmacists. Hence we have government licensed professionals providing these drugs according to laws approved by the federal government and the governments of the 50 states. If doctors don't write the scripts, then patients don't get the pills. I do agree that drug companies are not faultless. However, I see them as rich and easy targets. But, let's sue everybody and spread the blame around.

Outside of "doctors" running straight up pill mills they have pretty much skated on this whole mess. I can't speak for anywhere else but around here it seems to be straight up politics. The politicians run in the same circles as the doctors, the doctors donate to their campaigns, and no one wants to be the politician that went after clueless ol grandma and grandpa's doctor.

Hell they won't even go after the methadone clinic racket so I don't have much faith in them to do anything else. Except making it hard for everyone in legit need of it to get some fucking Sudafed. They are sure succeeding there.

[Ed L]

Government officials: Prescription drugs cost too much money!

Yes, people abuse painkillers. Just like they abuse alcohol. We see any state officials lining up to sue Anheuser-Busch for the number of people killed or maimed by drunks?

At this point when government officials talk about an "epidemic" it is probably a good sign that said official needs to be flushed.

Yes. These are clearly assault pills.

And the end result is that it is becoming harder and harder for people who need the pain pills to get them, harder to get adequate strengths, and harder to get prescriptions that last an adequate length of time.

They could bring back the TV show Breaking Bad and have Jessie cooking codine instead of meth--because an increasing number of people in need of pain meds will venture into the illegal market or start drinking to numb the pain.

In the long run the government will have made it worse for people and created more problems.

[Sensei]

There seems to be a fair amount of misinformation when it comes to this topic. Here is the Cliff Notes version of where we’ve been and where we are at.

1) Prior to the mid-80’s, it was exceedingly rare for opiates to be prescribed on a long term for non-cancer pain. During that time, a small cadre of physicians were employed by the pharmaceutical industry to reshape the lay and medical community’s opinions of opioids in preparation for several drugs that would enter the market within a decade.

2) In the late 80’s, this cadre of doctors published a few cases series of patients who received relatively short duration of opiate therapy without apparent consequences. Keep in mind that case series are some of the lowest forms of scientific evidence and there were no randomized trials looking at long term safety. However, these poor quality studies were cited by these doctors who were being employed by Pharma as evidence that the standard of care had shifted, and that opiates were safe for long term use in chronic, non-cancer pain. MS Contin was released in 1987 as the first oral long-acting opiate agent.

3) By the early 90s, a massive amount of money was pouring into professional societies (really shadow entities of the pharmaceutical industry) that were petitioning regulatory bodies such as Center for Medicare Services and the Joint Commission that accredits hospitals to become more aggressive with treating all forms of pain with opiates. Hence pain became a vital sign, doctors were sued and disciplined for not treating pain with opiates, and the medical system was primed for what was about to happen next.

4) In 1995 OxyContin was approved and within 2 years was one of the top 2 or 3 most prescribed medications in America.

5) By the early 2000s, portions of the medical community started to realize there might be a problem. Although OxyContin was thought to have low abuse potential, reports of it being injected were starting to crop up. Moreover, certain pharmacies were distributing massive amounts of the drug to relatively small populations. The manufacturer, Purdue Pharma, was aware of the irregularities and suppressed the information.

6) In 2010, a new, less abuse prone form of OxyContin was approved. Unfortunately, several other abuse-prone opiates were released (I.e. Opana). As for distribution, states without any controlled substance monitoring such as FL saw pill mill pain clinics flourish along I95. In the parking lots were license plates from OH, TN, WV, etc. Also at this time we were noticing a massive increase in opiate-related overdoses, opiate-complicated births, and mental health issues.

7) By 2014, everyone in the medical community knew there was a problem. Deaths from overdoses were at 60,000 and America was still seeing more and more total morphine equivalents being prescribed.

8) Between 2015 and present time we have seen a paradigm shift. Several studies were published including the first randomized trial of opiates vs. non-opiates for chronic pain. Known as the SPACE Trial, opiates were no more effective than non-opiates at controlling chronic pain and were associated with more adverse events - so much for patients “needing” opiates. Other studies showed that a course beyond just 5 days of opiate therapy was associated with future chronic opioid use and dependence, and most surgical patients need just 7-10 of opioid meds to control their symptoms.

9) By 2016, most states had significantly tightened their oversight of opiate prescribing. The cartels stepped in and began to fill the void with cheap heroin and fentanyl. A recent survey of heroin addicts showed that 70% began their road to opiate addiction with a prescription.

So, this was a system wide failure of the pharmaceutical industry, medical profession, federal and state regulatory bodies, and general public. It is good that the pharmaceutical industry is being held to account. Now it’s time to continue looking at outlier prescribers and hold them to account if they cannot show proper accounting and precautions. Finally, a complete overhaul of CMS and Joint Commission needs to be undertaken and scrutinized on how core measures and practice guidelines are developed and applied to the industry.

[BillSWPA]

I have not yet read the opinion and don’t know if I will have time to do so, but it should be kept in mind that, in our adversary system, the state had to prove its case, and the pharmaceutical company most likely had a team of highly paid lawyers trying very hard to stop them from doing so.



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