Portland, OR sues Pharma for $250M for Opioid Deaths

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drusso

drusso

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http://media.oregonlive.com/portland_impact/other/opioids.suit.pdf

Fishman, Portnoy, Webster, and AAPM all named as defendants. Oregon physicians and prescribers including as Stuart Rosenblum, MD; James David Gallant, MD; Julie Demille, NP; and Roy Blackburn, MD also named.
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These lawsuits bother me because they do not address what is in my mind the "real" problem which is the unscientific way medicine is practiced. In their favor i suppose these lawsuits might deter people but i doubt it. Why was no one sued after the results of the CAST trial came out? Because the unscientific practice of medicine is standard of care! Might as well sue the medical schools also. The animals are in control of the zoo.
//The Cardiac Arrhythmia Suppression Trial (CAST) was a double-blind, randomized, controlled study designed to test the hypothesis that suppression of premature ventricular complexes (PVC) with class I antiarrhythmic agents after a myocardial infarction (MI) would reduce mortality. It was conducted between 1986 and 1989 and included over 1700 patients in 27 centres.[1] The study found that the tested drugs increased mortality instead of lowering it as was expected.[2] The publication of these results in 1991/92, in combination with large follow-up studies for drugs that had not been tested in CAST, led to a paradigm shift in the treatment of MI patients. Class I and III antiarrhythmics are now only used with extreme caution after MI, or they are contraindicated completely.[3] Heart Rhythm Society Distinguished Scientist D. George Wyse was a member of the CAST trial's steering and executive committees.//
Cardiac Arrhythmia Suppression Trial - Wikipedia
How much did the USA spend on this one?
Failure of Extracranial–Intracranial Arterial Bypass to Reduce the Risk of Ischemic Stroke — Results of an International Randomized Trial
The EC/IC Bypass Study Group*

N Engl J Med 1985; 313:1191-1200November 7, 1985DOI: 10.1056/NEJM198511073131904
//Thirty-day surgical mortality and major stroke morbidity rates were 0.6 and 2.5 per cent, respectively. The postoperative bypass patency rate was 96 per cent. Nonfatal and fatal stroke occurred both more frequently and earlier in the patients operated on. Secondary survival analyses comparing the two groups for major strokes and all deaths, for all strokes and all deaths, and for ipsilateral ischemic strokes demonstrated a similar lack of benefit from surgery.//
MMS: Error
 
some pretty interesting statements in there

DAMAGES: $250,000,000.00

"As a matter of common sense and medical evidence, long-term use of opioids—drugs that can kill you or commit you to a lifetime of addiction—does not improve function or quality of life. To the contrary, if it does not kill you, long-term use of opioids will cause disability, disease, and distress."
 
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Interesting. Rosenblum and Gallant have both come in to our clinic to speak for abuse deterrent oxy and opana, respectively. Stuart is the guy the OBME asks to write an opinion when they discipline someone. He is a heck of a nice guy. I wonder why they don't go after the pill mill in Corvallis that brings patients in every month for a mass spec UDS at $500 each.
 
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It appears Oregon is pulling out all the stops and doing everything legally possible to stop the opioid overprescribing, including terrorizing physicians for a decade.
 
Maybe that is why he left what looked like a great opportunity. If only he had known that he could have picked up an extra $2400 at lunch time and then another $1600 at dinner by speaking for INSYS. Or he could have driven across town and bought a share if the UDS program. One of the docs there said that he got 40% of the reimbursement for the urine samples that he sent and that came to about $45,000/month.
 
Ligament said:
I dont think we should be doxing him...
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I didn't mean to dox 101N as much as I did the lawsuit and those involved. Skimming through it you can see that Gallant was getting 2400 from INSYS for a lunch. The lawsuit did even mention what he was getting when he did the lunch for us with Endo. And Rosenblum was getting 1600 for dinner. And through it all 101N abstained which I think is a credit. I am curious as to why he keeps moving as it seems that he has left more good jobs than I will ever have but I suppose a good job is in the eye of the beholder.
 
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onewithpain said:
I didn't mean to dox 101N as much as I did the lawsuit and those involved. Skimming through it you can see that Gallant was getting 2400 from INSYS for a lunch. The lawsuit did even mention what he was getting when he did the lunch for us with Endo. And Rosenblum was getting 1600 for dinner. And through it all 101N abstained which I think is a credit. I am curious as to why he keeps moving as it seems that he has left more good jobs than I will ever have but I suppose a good job is in the eye of the beholder.
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Wow his patient reviews are literally the lowest I have ever seen at 1.3 stars out of 4.

Maybe the patient's dont realize the brilliance of the moo shoo medicine from Roger Chou.
 
DOctorJay said:
some pretty interesting statements in there

DAMAGES: $250,000,000.00

"As a matter of common sense and medical evidence, long-term use of opioids—drugs that can kill you or commit you to a lifetime of addiction—does not improve function or quality of life. To the contrary, if it does not kill you, long-term use of opioids will cause disability, disease, and distress."
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Long term usage of NSAIDS have no long term evidence of benefit and kill 20K plus per year from kidney failure.

Long term usage of Lyrica has zero evidence and has been known to increase suicidal ideations, swelling, difficulty in weaning off, sedation that can cause car accidents while driving, etc.

Long Term usage of basically any drug in pain management has zero evidence past about 3 months of time for pain or functional benefit.

By this logic, we need to remove EVERY class of pain medication due to lack of long term studies.
 
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drusso said:
He doesn't work there anymore. His new employer:
Provider | Coelho, Paul C.
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I can't figure out what treatments this guy offers. All I can see is he recommends "opioid" reduction and "evidence based treatments".

I figure he repeats sending the patient to PT (who has already done this through his PCP), NSAIDs and Reiki therapy? Then says they are "cured" and don't need to do anything else despite the fact that the patients appear to remain in bad shape according to online reviews.

Wonder how much he charges for that.
 
lobelsteve said:
http://www.painmedicinenews.com/Cli...ines-Still-Under-Fire/42212/ses=ogst?enl=true
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Great article that I had read in the last few weeks.

AHRQ's analysis of the situation was extremely biased due stating there are "no long term studies on opioids" in isolation. This is how GIGO meta-analysis is done.

GIGO analysis includes:

1) Deeming studies they like "high quality" while ones they don't "low quality". They can largely obtain any results they want.

2) Doing an analysis in ISOLATION whereby they don't judge the alternative treatment options in a similar manner. Opioids are the PERFECT example whereby they claim there are "no long term studies" pretending this is a UNIQUE thing for opioid medications when forgetting that ALL MEDICATIONS for pain have NO LONG TERM STUDIES including NSAIDS, Lyrica, Cymbalta, Neurontin, etc. Attacking one class of medication while ignoring others in an "analysis" is very biased.

For instance, AHRQ analysis of "alternatives" such as NSAIDs does NOT state the ALL STUDIES on NSAIDS are SHORT TERM AS WELL or their HUGE SIDE EFFECTS. Would you rather give a Norco or an NSAID to a chronic kidney disease patient? If they were intellectually honest, they would state that they can't RECOMMEND ANY medication by their previous analysis.

But they largely supported one medication over the other based upon a dishonest analysis.

3) Fake discussions of "bias" whereby they will claim that that Purdue "did their own studies on Oxycontin and covered up the results".

This might be even TECHNICALLY true but it negates the fact that ALL DRUG STUDIES are basically done by the big Pharma company that produces the drug.

Ergo, the "bias" argument has to apply across the board but instead they single out specific ones.

How were the studies of Lyrica any less biased than for Oxycontin?
 
stop using a straw man.

(in case you forgot what that was: "A straw man is a common form of argument and is an informal fallacy based on giving the impression of refuting an opponent's argument, while actually refuting an argument which was not advanced by that opponent.")


the guidelines primarily address whether opioids are potentially harmful and probably not helpful.


In brief, five clinical questions were addressed:
  • The effectiveness of long-term opioid therapy versus placebo, no opioid therapy, or nonopioid therapy for long term (≥1 year) outcomes related to pain, function, and quality of life, and how effectiveness varies according to the type/cause of pain, patient demographics, and patient comorbidities (Key Question [KQ] 1).
  • The risks of opioids versus placebo or no opioids on abuse, addiction, overdose, and other harms, and how harms vary according to the type/cause of pain, patient demographics, patient comorbidities, and dose (KQ2).
  • The comparative effectiveness of opioid dosing strategies (different methods for initiating and titrating opioids; immediate-release versus ER/LA opioids; different ER/LA opioids; immediate- release plus ER/LA opioids versus ER/LA opioids alone; scheduled, continuous versus as-needed dosing; dose escalation versus dose maintenance; opioid rotation versus maintenance; different strategies for treating acute exacerbations of chronic pain; decreasing opioid doses or tapering off versus continuation; and different tapering protocols and strategies) (KQ3).
  • The accuracy of instruments for predicting risk for opioid overdose, addiction, abuse, or misuse; the effectiveness of risk mitigation strategies (use of risk prediction instruments); effectiveness of risk mitigation strategies including opioid management plans, patient education, urine drug testing, prescription drug monitoring program (PDMP) data, monitoring instruments, monitoring intervals, pill counts, and abuse-deterrent formulations for reducing risk for opioid overdose, addiction, abuse, or misuse; and the comparative effectiveness of treatment strategies for managing patients with addiction (KQ4).
  • The effects of prescribing opioid therapy versus not prescribing opioid therapy for acute pain on long-term use (KQ5).
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now, the CDC does discuss multimodal treatment, of note, this is quoted:
Nonopioid pharmacologic approaches used for pain include analgesics such as acetaminophen, NSAIDs, and cyclooxygenase 2 (COX-2) inhibitors; selected anticonvulsants; and selected antidepressants (particularly tricyclics and serotonin and norepinephrine reuptake inhibitors [SNRIs]). Multiple guidelines recommend acetaminophen as first-line pharmacotherapy for osteoarthritis (104–109) or for low back pain (110) but note that it should be avoided in liver failure and that dosage should be reduced in patients with hepatic insufficiency or a history of alcohol abuse (109). Although guidelines also recommend NSAIDs as first-line treatment for osteoarthritis or low back pain (106,110), NSAIDs and COX-2 inhibitors do have risks, including gastrointestinal bleeding or perforation as well as renal and cardiovascular risks (111). FDA has recently strengthened existing label warnings that NSAIDs increase risks for heart attack and stroke, including that these risks might increase with longer use or at higher doses (112). Several guidelines agree that first- and second-line drugs for neuropathic pain include anticonvulsants (gabapentin or pregabalin), tricyclic antidepressants, and SNRIs (113–116). Interventional approaches such as epidural injection for certain conditions (e.g., lumbar radiculopathy) can provide short-term improvement in pain (117–119). Epidural injection has been associated with rare but serious adverse events, including loss of vision, stroke, paralysis, and death (120).
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and it is noted that the CDC does specifically discuss risks of other nonopioid therapy:
Nonopioid pharmacologic therapies are not generally associated with substance use disorder, and the numbers of fatal overdoses associated with nonopioid medications are a fraction of those associated with opioid medications (contextual evidence review). For example, acetaminophen, NSAIDs, and opioid pain medication were involved in 881, 228, and 16,651 pharmaceutical overdose deaths in the United States in 2010 (178). However, nonopioid pharmacologic therapies are associated with certain risks, particularly in older patients, pregnant patients, and patients with certain co-morbidities such as cardiovascular, renal, gastrointestinal, and liver disease (see contextual evidence review). For example, acetaminophen can be hepatotoxic at dosages of > 3-4 grams/day and at lower dosages in patients with chronic alcohol use or liver disease (109). NSAID use has been associated with gastritis, peptic ulcer disease, cardiovascular events (111,112), and fluid retention, and most NSAIDs (choline magnesium trilisate and selective COX-2 inhibitors are exceptions) interfere with platelet aggregation (179). Clinicians should review FDA-approved labeling including boxed warnings before initiating treatment with any pharmacologic therapy.
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however, it is not stated in the guidelines anywhere to specifically use a different drug or medication combination over opioids.


additionally, the CDC did its own review above and beyond that done by AHRQ.
 
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Ducttape said:
stop using a straw man.

(in case you forgot what that was: "A straw man is a common form of argument and is an informal fallacy based on giving the impression of refuting an opponent's argument, while actually refuting an argument which was not advanced by that opponent.")


the guidelines primarily address whether opioids are potentially harmful and probably not helpful.




now, the CDC does discuss multimodal treatment, of note, this is quoted:


and it is noted that the CDC does specifically discuss risks of other nonopioid therapy:



however, it is not stated in the guidelines anywhere to specifically use a different drug or medication combination over opioids.


additionally, the CDC did its own review above and beyond that done by AHRQ.
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Didn't I say AHRQ?
 
Ducttape said:
stop using a straw man.

(in case you forgot what that was: "A straw man is a common form of argument and is an informal fallacy based on giving the impression of refuting an opponent's argument, while actually refuting an argument which was not advanced by that opponent.")


the guidelines primarily address whether opioids are potentially harmful and probably not helpful.




now, the CDC does discuss multimodal treatment, of note, this is quoted:


and it is noted that the CDC does specifically discuss risks of other nonopioid therapy:



however, it is not stated in the guidelines anywhere to specifically use a different drug or medication combination over opioids.


additionally, the CDC did its own review above and beyond that done by AHRQ.
Click to expand...

The CDC is incorrect and opiate overdoses versus other drugs that cause fatalities. If you look at the data regarding NSAIDs compared to opiates, there are more NSAID fatalities than opiate fatalities if you only include the patients where the drug was prescribed directly to them. Substance abuse is a real problem but heroin is not prescribed and diverted drugs are not to be included in what our patients are dealing with.
 
lobelsteve said:
The CDC is incorrect and opiate overdoses versus other drugs that cause fatalities. If you look at the data regarding NSAIDs compared to opiates, there are more NSAID fatalities than opiate fatalities if you only include the patients where the drug was prescribed directly to them. Substance abuse is a real problem but heroin is not prescribed and diverted drugs are not to be included in what our patients are dealing with.
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The Heroin junkies are our fault of course, don't you know Steve? Not their fault at all.
 
Ligament said:
The Heroin junkies are our fault of course, don't you know Steve? Not their fault at all.
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Everything is our fault.

Like Lobel stated, more patients die of LEGALLY prescribed NSAIDS compared to LEGALLY prescribed OPIATES every year.

So for the AHRQ to recommend NSAIDS is laughable.
 
Well on the other hand you probably won't get shot if you cut off a patient's Celebrex
 
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