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A larger failure

The Washington Post had an investigation, it had been published months ago (at https://www.washingtonpost.com/investigations/the-opioid-crisis-15-percent-of-the-pharmacies-handled-nearly-half-of-the-pills/2019/08/12/b24bd4ee-b3c7-11e9-8f6c-7828e68cb15f_story.html) and I did look at a few sides of what was happening, yet the larger failure was never looked at. The fact that the DEA has failed its nation to this degree is almost too weird for words.

The headline might give us: ‘As overdoses soared, nearly 35 billion opioids — half of distributed pills — handled by 15 percent of pharmacies‘, there was a clear need to investigate the pharmacies and the FDA who had been a failing regulator in all this, yet the Washington Post gives us that there is enough blame to go around. When we see: “The DEA has maintained this database for roughly two decades but did not regularly mine the records to identify pharmacies buying unusual quantities of opioid pills, according to current and former DEA officials. The agency relies on drug companies and pharmacies to monitor and report suspicious purchases“, we see more than mere stupidity and laziness, the DEA shows that there is a systemic failure in America. The mere mention of ‘The agency relies on drug companies and pharmacies to monitor and report suspicious purchases‘, shows just how stupid the DEA has been, a stage where a commercially driven enterprise will monitor itself has in all of history never ever worked. Looking at the top 15, the three pharmacies in Kentucky sold enough opioids to hand every citizen in Kentucky 3 tablets each, that is merely the three pharmacies in that list, and there are close to 300 (as far as I have been able to count them). The simplest stage that I could have shown the DEA using IBM modeller/IBM statistics in less than one hour (providing the data was transferred).

The DEA and the FDA failed to this degree. A stage that could have been addressed half a decade ago, it was never mined; that is the size if what I will plainly call incompetence. Even as the New York Times gave us Yesterday: ‘Judge Orders Pause in Opioid Litigation Against Purdue Pharma and Sacklers‘, we see (at https://www.nytimes.com/2019/10/11/health/purdue-bankruptcy-opioids.html) that there is another stage, it is not about the “mounting costs of litigation”, I see that there is a larger systemic failure and whilst we accept that the people can go after Purdue Pharma and its owners, the Sacklers. There is a clear stage where the FDA and the DEA should have stepped in half a decade ago, they did not!

Even as politicians and law makers are giving rise to the option “They would also give up ownership of Purdue, which would be restructured into a new company, overseen by public administrators. The new company would continue to sell its signature opioid, OxyContin, as well as other medications, but all profits would go to pay the cities, counties and states for the costs of the opioid epidemic“, that sounds nice, but in the end the problem is larger than one company and the failure of the DEA is out in the open and left alone, untapped and not really investigated, the same can be said for the FDA in all this. Large companies had too much hold on these institutions and now that the dam is build, this can all happen again. Sanitation of the DEA and FDA will be essential in all this.

Even as there is in the most extreme some validity to the claim by B. Douglas Hoey, chief executive of the National Community Pharmacists Association when he gives us “There are legitimate reasons small pharmacies can have outsize volumes” so far his words do not sound true. The fact that three in Kentucky and the list of 15 pharmacies where the smallest transgressor prescribed 65 pills per person with a total of 1,294,890 pills (in Oklahoma of all places), we see a large failure and the rods by Hoey come across as hollow. In this the National Community Pharmacists Association should have mined its data as well, that was seemingly never done to any degree. I would have needed less than an hour to see initial top line results and raise red flags all over America. The idea that someone in West Virginia prescribed 70 pills per person and in total prescribed 13,168,350 pills should be out in limelight, none of the three ever gave this, none of them decided to arrest the people in Strosnider in Mingo County and prosecute them (after investigations) regarding the prescriptions of opioids.

When we get the results where over 6 years 15% of the pharmacies received 48% of pain pills is a metric that is too unacceptable and Hoey hiding behind “The numbers don’t always tell the whole story” clearly implies that he needs replacement, in addition the entire facilitation towards pharmaceutical companies must change. In addition, when the Post gives us “Many of the high-volume pharmacies had annual double-digit growth in pain pills and bought far more opioids than competitors in the same counties. The analysis also considered proximity to urban centers“, I feel certain that there is a lot more in those numbers and beyond the need for greed there is no valid explanation forthcoming any day soon. A systemic failure that is now the driver behind an addiction pandemic. The disbelieve merely grows when we are confronted with: “A judge recently ordered the release of seven years of database records, which expose the paths of more than 70 billion pain pills distributed to about 83,000 pharmacies“, this gives us an average of a little over 843,000 pain pills per pharmacy over 7 years, making it 120,000 pills per pharmacy per year. A simple search via:

SPLIT FILE PER YEAR pharmacy.
FREQUENCIES
/NOTABLE
/STATISTICS=mean.

It would have given us the results of something that would have knocked over any junior analyst making that person push every red alert that this person could lay their hands on. One hundred and twenty thousand pain pills per pharmacy per year is a massive result! The fact that the DEA and the FDA fell short of something I typed in 14 seconds shows just how large the failure is (processing that amount of data takes additional time). I reckon that if I started this in 2013, with a monthly dashboard, I feel 99.5% certain that the phones of the top brass of the FDA and the DEA would be red hot from every politician that saw those results.

If I had changed it towards:

SPLIT FILE PER YEAR STATE pharmacy.
FREQUENCIES
/NOTABLE
/STATISTICS=mean MIN MAX STDDEV.

I would get a lot more to work with, in addition as those who do not prescribe pain pills would not be part of the numbers, the results would be rather interesting to read and this is merely top line results, when we start digging into the numbers and start looking into the specifics like Kroger Pharmacies (KY) and Walmart Pharmacies (KY) and look at them per state (merely examples) we will get an even more descriptive stage of the data involved, so when B. Douglas Hoey stated: “The numbers don’t always tell the whole story” he ended up being more wrong than you could ever imagine, it is not merely the numbers, it is about asking the right questions, but he did not offer that point of view, did he?

The failure of the DEA becomes a larger issue when we see: “A DEA spokesman said he could not provide a complete list of all enforcement actions by the agency against pharmacies nationwide for violations of the Controlled Substances Act“, this shows a failure in logistics and organisation, In all this the National Community Pharmacists Association has a larger role to play, if the quality of a pharmacy is everything, any association would need to remain aware of any legal and prosecution issues playing, not merely because it is a prosecution or an action, but it is up to the association to make sure its members are aware of issues that play in the legal and enforcement field in all this, so there is a carpet hiding a truckload of trash, even as we point at the DEA, the failure is actually larger and involves pharmaceutical corporations, the FDA, the DEA, the Pharmacy association, as well as optionally accounting, bought and sold pills should be in the audit, something this big would have had to show up, unless the books were designed to keep such numbers out of view, yet when one player (Strosnider, Mingo County, WV) sells 13,168,350 pills whilst prescriptions are set to $6 per pill, that one place has to book $13 million dollar per year on pain pills only, and that was NOT noticed?

Go cry me a river!

The failure is large, the stage that the Washington Post gives us is merely one side, the NY Times gives another part, but the overall failure where the US government collects all data and does nothing is the real largest failure. As the NY Times gives us: “the eight individual Sacklers who are typically named in the litigation argue that because they have been sued for their roles with Purdue, Purdue’s protection in bankruptcy court should cover them too“, yet the US government (specifically FDA and DEA) had the data and for the longest time they apparently did nothing, in a stage of such a systemic failure, will anything ever get resolved?

 

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Legally dopey dealings

We all know people who are out and about, some are out for dope, others are merely dopey. As such we have all kinds of checks and balances in place (or so one would think). It was there for a little surprising to see: ‘Johnson & Johnson responsible for fuelling opioid crisis in Oklahoma, judge rules‘ (at https://www.theguardian.com/us-news/2019/aug/26/johnson-and-johnson-opioid-crisis-ruling-responsibility-oklahoma-latest). I was of the mind that this would not happen. Not because I like the firm, not because I like the product Pledge (for my furniture), and optionally I use other materials by Jay & Jay, I merely am unaware of it.

I am also not debating the events, or the guilt of Johnson and Johnson, I merely have a lot of other questions, questions that as far as I can tell are not answered. To get there, we need to see the accusation: “the giant drug maker helped fuel the deadly opioid epidemic in the state“, first of all, there is a larger failing. When we focus on the ‘deadly opioid epidemic‘, we need to see that this does not go over the counter. So when we look at the words of AG Mike Hunter “a “cunning, cynical and deceitful scheme” to ramp up narcotic painkiller sales alongside other opioid manufacturers by using their huge resources to influence medical policy and doctor prescribing“, I wonder who these prescribing doctors were. Did they not study medicine? The fact that thousands of doctors prescribed opioids is a larger issue, it does not make J&J less guilty, it makes others a lot less innocent. J&J should not be standing there alone. The claim “selling as many narcotic painkillers as possible” calls for an inclusions of the doctors giving out the recipe and the pharmacy accepting that doctors kept on prescribing the drug. We also need to look at the FDA who approved the drug in the first place. Here we are looking at three guilty parties, with two groups consisting of thousands of people involved. Yet the article shows merely a J&J in the dock, having to shell out $572,000,000. This leads to questions that do not add up.

In addition we see: “Oklahoma resolved claims against Purdue Pharma in March for a settlement of $270m and against Teva Pharmaceutical Industries in May for $85m“, it calls for additional questions and they are not given, it seems that the essential questions are not even asked in the article. Even the CDC has questions to answer. This part is given with: “Opioids were involved in almost 400,000 overdose deaths from 1999 to 2017, according to the US Centers for Disease Control and Prevention“, there is already a clear case on how these opioids were prescribed, yet we see nothing of that. And as the article continues with: “Since 2000, some 6,000 Oklahomans have died from opioid overdoses“, this implies 300 deaths a year and we see nothing demanded from doctors and more important on how dosage had this effect. All elements that might be attributed to J&J, but it took a doctor to decide on the medication, is that not the case?

The truth of that is seen at the very end of the article by John Sparks, Oklahoma counsel for Johnson & Johnson. “Not once did the state identify a single Oklahoma doctor who was misled by a single Janssen statement, nor did it prove that Janssen misleadingly marketed opioids or caused any harm in Oklahoma“, I would phrase it: “Not once were doctors and their pharmacies called to explain these numbers, the total numbers who got prescribed these opioids and not once do we see any alerts to the CDC on any of this“. The evidence in this is that the 22,500 overdoses a year should have rattled the CDC no later than 2003, so where are the actions shown that there was an issue? The American pharmacy system failed on several levels and even as no one denies that Johnson and Johnson had a role to play, the FDA and the CDC should have clearly intervened no later than 2005 that is seemingly not the case, because the cadavers kept on stacking for at least another decade.

It took me less than 600 seconds to see this truth; as such Mike Hunter is actually dealing with a massive systemic failure that goes all the way to his own office.

And as we read: “cunning, cynical and deceitful scheme“, it seems more apt to accuse the office of the Attorney General for inaction, complacency on a matter that endangered the lives of hundreds of his state constituents every year and his office has remained inactive for well over a decade, it seems to me that his office should equally be investigated for reckless endangerment of people. In all this the pharmacies and doctors need to be heard on how and why these patients were prescribed. My view was supported in July 2019 when we were told (by the Guardian) “The company has previously acknowledged delivering 5.7m opioid pills between 2005 and 2011 to the small town of Kermit, West Virginia, with a population of just 380 people“, this shows the larger extent of pharmacies and their distributors. More important, who was prescribing these opioids?

We can argue that Johnson and Johnson is guilty or innocent, yet the truth is that this reckless abuse system is a lot larger than the pharmacy creating the opioid containing medicine, it is a much larger greed driven setting and I believe that Oklahoma and specifically Mike Hunter failed the American people. He might feel all happy and joy joy that he won the case, yet I believe that it is merely part in covering up a much larger crime that goes all the way to the top of the CDC, as well as a national pharmacy failure. The article does not give us that, does it?

It gets to be even a little wilder when we consider a 1978 episode of Lou Grant (season 2 Episode 1 – pills). In that episode we get a similar setting, more important, in the dialogue at the end we hear: “246 kids went to the same three places. Druggists are obliged to report any doctors who are prescribing abnormal amounts of dangerous drugs, the state pharmacy board had not received a report from any of the three“, now I accept that this is the text from a TV series, a drama series. Yet the premise remains, is there a legal premise in the US (still) in place that this reporting needs to happen? If there isn’t why was this never done? The danger of substance use disorder has been around for decades, this failing cannot be held over the head of a pharmaceutical company. There is a clear indication of violations on local, state and federal level, it is a systemic failure and we might large applause that a large pharmaceutical gets the bill, but the failing is much larger and because of that there is an injustice in all this.

I believe that Johnson and Johnson has a much larger role to play and they are not innocent, yet the failing is systemic, as such there is every chance that their appeal will have large consequences on a national level in America.

I wonder if Ed Asner, Robert Walden and Mason Adams ever considered that they would be part of a stage where they pointed out a much larger American failing 4 decades before it went to court. I remember the series as I was almost 18 (just two years short of that) and It was my dream to become a wartime photo journalist (a younger Daryl Anderson). It was not meant to be, but I never lost my passion for photography.

This case is more than we see and I reckon that jurisprudence papers will soon enough fill up on the systemic failings that Mike Hunter is eager to avoid in the court room.

Even now, we see another article from the Guardian that is almost an hour old. There we see: “It was also revealed that Johnson & Johnson hired the consultants McKinsey, which recommended the company’s sales force should focus on doctors already prescribing large amounts of Purdue’s OxyContin”, there is a level of validity of looking into that practice, yet the part linked to all this, the doctors prescribing the medication in the first place, they had a duty of care towards their patients. A marketing strategy might be debatable, it might also be immoral, yet in the end the doctor is the one acting, so is the pharmacy handing it out again and again, where are they in all this?

It is in that article where we see a two sided issue (at https://www.theguardian.com/us-news/2019/aug/26/johnson-and-johnson-opioid-crisis-ruling-responsibility-oklahoma-latest), with: “Sabrina Strong, one of the trial lawyers for Johnson & Johnson, said the ruling was flawed. The company argued that the drugs it sold were approved by federal regulators and that they could not be tied directly to any deaths in Oklahoma”, we see that Sabrina Strong is opening two doors, one bad one. Yes, we can agree that they were approved; the error was ‘they could not be tied directly to any deaths’. Were all hundreds each year all vetted? That is the flaw, because that data could also reveal which physicians prescribed them and which pharmacies filled the prescription. That evidence was not covered by the media, and as this goes over almost two decades, how did the CDC cover this? 300 deaths a year in one state is too large to ignore, especially when it is part of a larger failing. That is the part that Johnson and Johnson have seemingly not covered. I feel certain that the appeal will cover it and it will make life for Mike Hunter a much larger problem than he realises.

 

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The wrong claim to make

I have been taking a much larger interest on the entire Facebook and Cambridge Analytica issue. Not because of what was done, but because of what US politicians are about to try. In that view it seems to me that the media is assisting the US government. Pretty much every media publishes ‘Zuckerberg on Tuesday faced a variety of questions from 44 senators‘, yet not one gives us that list of these 44 senators. Online publication Vox had a list of 103 which was equally useless. So why are the readers not getting properly (read: more completely) informed?

As I have a promise to keep (to myself at least), let’s take a look at the first one who really pissed me off. The person in question is U.S. Representative David McKinley, not even a senator. Yet with the quote “Your platform is still being used to circumvent the law and allow people to buy highly addictive drugs without a prescription. With all due respect, Facebook is actually enabling an illegal activity and in so doing, you are hurting people. You’d agree with that statement?” he opened himself to all kinds of issue. So let us take a look. CNN gives us (at http://money.cnn.com/2018/04/11/technology/mark-zuckerberg-questioned-over-facebook-opioid-sales), with the additional quote “Google agreed to pay $500 million to the Department of Justice for showing prescription drug ads from Canadian online pharmacies to U.S. consumers. It stopped the practice in 2009 once it became aware of an investigation by a U.S. Attorney’s office. But sellers are still finding ways of posting about drug sales on platforms like Facebook and Instagram, which critics have accused of being reactive, largely waiting for activists, or the press, to surface issues and help police their platforms“, so the issue is a lot larger and has been around for a long time. So the US representative is not opening legal avenues attacking the Canadian Online pharmacies, no it is attacking Facebook and Google. The issue here is hypocrite on several levels. You see we see part of that evidence (at http://www.cbc.ca/news/opinion/oxycontin-in-canada-1.4607959), even as the investigation into Purdue Pharma is underway, the issue is a lot larger. We get one part from ‘OxyContin was aggressively marketed as a revolutionary painkiller. But many patients became addicted, leading to a country-wide class action lawsuit against its maker‘, the other part is seen in the NPR event “Doctors In Maine Say Halt In OxyContin Marketing Comes ’20 Years Late’“, so we see the news that is given in February 2018. These facts alone give rise to the geriatric dementia dangers that are possibly within business man David McKinley, a man currently elected as a U.S. Representative. In addition to that part, the fact that the US government failed its citizens is open to discussion in the 2015 release of “the Food and Drug Administration. (FDA) approved, in August 2015, extended-release oxycodone for use by children between 11 and 16 years old with “pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate“, so there is a much larger failure in play. The fact that the FDA approves (for specific reasons mind you) the use of OxyContin and the fact that it is FDA approved makes it a much larger issue.

The fact that there is ample evidence that US politicians were sitting on their hands for close to 2 decades gives rise to the thought that U.S. Representative David McKinley should give up his seat in what I personally would see as too old to hold any public office position, perhaps at 71 he no longer sees the need to correctly set the dimension of information of any issue. His attack, the fact that this is a lot more complex, in part because the US government chose to not act for 2 decades is also decent evidence to add in this case. In addition, we see that the reformulation to make it harder to abuse opioids (which is an act that makes perfect sense), gave way to ‘Making opioids harder to abuse led to a spike in heroin overdoses‘ (at https://www.axios.com/opioids-heroin-overdose-deaths-1523481019-63cfb423-e1fc-4925-9a80-3406625389b5.html). Here we see “Adapted from Evans et. al., 2018,  “How the Reformation of OxyContin Ignited the Heroin Epidemic”, The National Bureau of Economic Research; Note: “Opioids” includes all opioid related deaths aside from those that are exclusively attributed to heroin“, so basically the junkies and their facilitators found another way to get high and they died in the process (serves them right). It seems that as I found all this evidence in less than 30 minutes and there is almost 20Mb of unread text for me to go through, shows just how lame (or is that blatantly idiotic) U.S. Representative David McKinley is showing himself to be. There is an accepted issue that in some cases non-US advertisements have no business being shown in the US, yet in that situation, my e-mail wad been flooded with the options for silicone tits, 14 inch sausages, Viagra and Cialis for well over a decade from US sources, so how much ‘policing’ did these US senators opt for from 1996 onwards to ‘protect’ non US citizens from these ‘illegal’ drugs? It seems to me that this is an almost perfect example of ‘sauce for the goose, sauce for the gander‘, yet we can feel decently certain that U.S. Representative David McKinley will not see it that way. In addition to that CNN gives us “More than 63,600 lives were lost to drug overdose in 2016, the most lethal year yet of the drug overdose epidemic, according to a new report from the National Center for Health Statistics, part of the US Centers for Disease Control and Prevention. Most of those deaths involved opioids, a family of painkillers including illicit heroin and fentanyl as well as legally prescribed medications such as oxycodone and hydrocodone. In 2016 alone, 42,249 US drug fatalities — 66% of the total — involved opioids, the report says“, this has been going on for a while; this was not merely some Facebook advertisement issue. The CDC shows data going back to 2000, long before Facebook became the behemoth entity it is now. So whilst everyone is kicking up every stink in the place, the issue remains that the FDA approved Purdue Pharma to start making it, so even as U.S. Representative David McKinley could have been visiting their office in Stamford, Connecticut, USA. It is now shown that kicking it on the soul of Mark Zuckerberg is much more personally rewarding for him. In that his quote “why Facebook hasn’t done more to remove posts from sellers offering illicit opioids“, in equal measure does not show the efforts that the FBI has done to crack down on the sellers either. You see, if he had done that we would have ended up (at https://www.cbsnews.com/news/opioid-fentanyl-darknet-drugs-fbi/), showing just how easy it is to the evidence we see here: “Attorney General Jeff Sessions said darknet vendors are “pouring fuel on the fire of the national drug epidemic” and this year doubled the number of federal agents working on those cases. It’s part of the Trump administration’s tough approach to the drug crisis that has focused on harsh punishments for dealers. Critics say the overall strategy resembles a return to failed drug-war tactics and that the record $4.6 billion included in the spending plan the president signed last month is not nearly enough to establish the kind of treatment system needed to reverse the crisis“, it does not absolve Facebook, but it shows that when you are in a house without a roof, blaming the faucet for all the water is just as stupid as it gets. So with this small article I introduce the honourable U.S. Representative David Bennett McKinley, who should, as I personally see it, be up for replacement at the next election.

And may he be replaced by someone who truly takes a proper look at the dimensionality of events and present them equally correct and fair. So we will leave that consideration up to the people who are part of the West Virginia’s 1st congressional district. I reckon that with a population of 615,991 (2010) there is at least one other person who is up for the job.

Now, let’s take a look at the data of the next elected numbskull, have a great Friday all!

 

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