Tag Archives: FDA

Update to include monsters

I was thinking of some of the old games I used to play, especially one I never mastered. The game was released in 1985; I played the Atari ST edition. The game was called ‘Balance of Power‘ and it was basically the east versus the west and through the interface you could interfere (take control of) the balance of power between east and west. In the end I got overly comfortable to the expression “You have ignited a nuclear war. And no, there is no animated display of a mushroom cloud with parts of bodies flying through the air. We do not reward failure“, yes diplomacy was never my forte. There was an update 5-10 years later when the 1990 edition was launched, I never played that edition.

I believe that the world is ready for a true update of that game. When we add the atrocities by Turkey only a few days ago, when we add the Khashoggi debacle and the impact of social media and spin doctors at the heads of media outlets we see that the world has changed to a much larger degree and the impact of what actually could happen is perhaps worthy of a new game. We need to see and play with the impact of ISIS minded forces as political parties play with the impact on a global stage. The fact that the USA is no longer a real superpower and the fact that the treasury of Saudi Arabia, the consumer base of India as the technology footing of China are much larger influences than foreseen; we get to debate a much larger spectrum of what the balance of power looks like. I believe that when the people see the impact of these elements, we see that the world reshapes almost like some Sim City version with larger repercussions. When we consider the global powers of Google and Facebook we see that the game of world politics gets filtered by economic markers. The evolution of what was once regarded as the ‘Balance of Power‘ is optionally now the stage for a larger form of balance (or is that a forum of balance) staged in a collection of seesaws where one resets the balance of two others. the old balance of power staged on the bear and eagle are outdone, less valid, the entire proxy war between Saudi Arabia and Iran clearly shows that and the impact of the media as they filter the news is also a larger impact and we have never been able to truly look at the impact there is, hence the idea of a new Balance of power, optionally called: ‘the Power to balance powers‘, the optional new truth that Turkey is the fourth power to instigate multiple genocides (America as it degraded the population of Native American tribes to zero, as well as the Catholic powers who removed well over a dozen civilisations, and Russian combined actions in 1931 and 1932) is something we need to consider in a much larger scope.

It is this stage where we look at the news and we are confronted with ‘The Kurds’ commander in chief explains why his forces are finally ready to partner with Assad and Putin‘, I have no way of seeing how this plays out, but there will be larger repercussions on many stages. It is time that the youth takes a serious look at the large issues that their parents are dumping on their doorstep, we need to figure things out and it is time that this is done out in the open, no longer hidden behind a screen of media filters and silencing diplomatic teams as they are trying to remain ‘non-accountable’ towards actions chosen.

The problem is not merely that we ignore the actions; the larger stage is that all kinds of ‘compromises’ are being made for the long term and the next generation needs to learn what those repercussions are and I believe that the right video game could do this. The previous generation was apparently taught that evil should never be allowed to win, yet 25 years after WW2 we all became complacent and we thought that evil was gone, evil never is and we all have optionally become part of evil as we condone the actions of many, hide behind the shallow needs that social media offers and we remain unaware as the news is decided by the wealthy (read: corporations) as they became the shareholders, stake holders and advertisers; they get to tell the media and the news what is important, what is filtered out. That is the stage where the balance of power can educate a lot of people just how dangerous our status is at present, not dangerous as if a war comes, we are beyond that, I mean dangerous as we have set the stage for multiple generations of anger, hatred and feelings of revenge, and a growing lack of tolerance towards one another. It is almost like a 4 seat seesaw and each of these seats is the balancing point for another seesaw, it becomes a game of trying to stay balanced, it also means that there is a lack of movement available, which implies that some parties will be about claiming actions when none (or that specific one) was not available.

when we see the media, we are pushed to the question ‘What is the omitted Information that Remains Missing?‘, this is a spin on two levels, the first is ‘Which question should have been asked?’, which brings us to ‘Has a quote or testimonial been taken out of context?‘ this is harder to answer, but it is an influence, which gets influenced by: ‘Is someone approaching the issue from a different set of values?‘, as well as the stated answers ‘Are the claims supported by well-done research as well as based on reliable sources?‘ and that is the foundation for merely looking at the media how it filters information, the entire stage becomes a much harder game to program, yet should it not be done because of that?

And that is all before we get to the political and diplomatic stage on “If the answer is not helpful, can we change the question to make it so?” these two elements interacting in media causes all kinds of communication (read: presentation) issues whilst both sides remain intentionally ignorant to the equation. The next generation needs to be educated on what a mess this generation is creating. That part is seen (only in part) with: ‘12 Hours. 4 Syrian Hospitals Bombed. One Culprit: Russia‘ (source; NY times), with the quote “The Russian Air Force has repeatedly bombed hospitals in Syria in order to crush the last pockets of resistance to President Bashar al-Assad, according to an investigation by The New York Times“, which was set to events on May 5th 2019, many newspapers gave that information when it happened, the repeat from the NY Times gives us the quote “Russia’s position as a permanent member of the United Nations Security Council has shielded it from scrutiny and made United Nations agencies reluctant to accuse the Russian Air Force of responsibility“, this is important as the United Nations Security council is now presented as an umbrella that offers a shield from actions it was supposed to stop, a stage we knew existed, but not to the degree we see now.

So when we see the NY Times quote: “Nabad al Hayat Surgical Hospital in southern Idlib Province served around 200,000 people before being destroyed in a Russian airstrike on May 5” which comes with assisted high resolution graphics of 40 mega pixels or better whilst we look at the exploding hospital, we wonder how lucky that photographer was, or perhaps someone knew in advance what would happen, we are left with too many questions and no real explanation that fits the morality and values within us.

It is becoming more and more important that we see the world as it is now being pushed by the monsters among us, we like to set the stage to merely Iran, Turkey, ISIS and Hezbollah, yet the real monsters are the ones claiming to fight the atrocities and in the end merely facilitate to it, it goes beyond the wear events, the technological feats we see in regards to 5G is also a global impact, and we can go on and on on all the events that are part of the stage, and it would soon become too complex. Perhaps that too would be the strength on any new version of ‘Balance of Power‘ the fact that too many issues are intertwined for several reasons. Yet when we add greed to the mix, the game becomes awfully transparent, add to that the actions by some making claims that they cannot prove; the created stage of carefully phrased denials, all out in the open and when we ask specifics we are left with half-baked answers that are not answers at all. This is a part that plays a role in all this, we seem to forget that governments have a duty to properly inform us, yet in the listing from government, through corporations to media to the viewer, we forget that there are three iterations of information, all bound by their own personal issues. It is almost an applied variation from Mark M. Lowenthal ‘Intelligence: From Secrets to Policy‘, the application of stages towards the drive of any policy (governmental or not) is also baked into the media and is subject to what we are allowed to see. Consider that impact, as well as the impact of data on the whole, it might become a massively complex new game, yet when we are able to show the impact of these elements to the people, we would optionally get a much more informed person, one who ends up asking the right questions, the questions that politicians, CEO’s and CFO’s fear. When that part comes out in the open, we get a first stage to truly fix things.

Yet with my sense of humour, we should make a lot more space to include the stages that Darrell Huff introduced us to when we were given ‘How to Lie with Statistics‘, and this gets us to today, we know that the balance of power is not merely what we have, what we get and how we get there. There is an internal stage where political power is also set to the stage of people in jobs (as enabled consumers) that was proven ages ago. Yet how that stage is managed is an entirely different matter. the pushed stage where enablers, facilitators and consumers become the ‘have group’ the rest will be the ‘have not’ group.

As we got told today (source: the conversation), we see this stage in Australia, “Centrelink generally requires evidence of looking for 20 jobs per month in order to keep receiving Newstart“, that sounds fine in theory, yet in the applied practice we see that the job search government links to a job search collector, whilst the seeding player of this group is another matter. So when we look at IT jobs in Sydney we see: ‘594 jobs with 715 positions‘, with the largest bulk (over 90%) being Adzuna, yet the reviews from some are stating that this source is riddled with ‘scam’ mentions, as well as overly positive claimed stages. There is a larger issue afoot and there is not enough scrutiny, even as the people can go to really valid places like Indeed, LinkedIn and Jora; the choice we see in the governmental site calls for question of scrutiny.

Why on earth did I mention that?

We see that the balance of power is set to what is done and what can be achieved, yet when we are confronted with a stage that is not available or realistic, how will we interact? When we are set in a stage of age discrimination on a stage where our issues are not heard, or set in a long winded stage of registration where the IT parts fails too often, the government gets to optionally report that no complaints were received. In Australia the mess with Centrelink data matching, the failing Biometrics Identification Services, the UK failures on IT in the NHS and the list goes on where the costs keeps on adding billion after billion, that directly impacts a government, its budget and its waning options, very much issues on a larger scale and the claim we see with “aggressive ICT outsourcing has led to agencies being left at the mercy of external vendors“, whilst there is no proof that growing the internal options would not have resolved the issue. It is a stage where corporations have a hold over the government, pushing cheaper solutions (another reference to age discrimination get pushed to the backbench and no solutions come forward. this is a direct application of the earlier mentioned ‘in the listing from government, through corporations to media to the viewer, we forget that there are three iterations of information, all bound by their own personal issues‘, which in the application of the Balance of Power means that corporations have a much larger option to disable or limit government actions. That is what the impact of corporatocracy is. In the original games there was no real corporatocracy, nowadays there is. The US is perhaps the strongest example and the impact we see in the FDA and DEA (see yesterday’s article) as well as the ATF limited through the powers of the NRA and by corporations addressing attachments to governmental needs we see a larger impact of where governments show limitations on the world stage.

Yes, the entire game has become a lot more complex which in the end leads us to the question, is any application of the ‘Balance of Power‘ still actual and realistic? That is partially seen in 2013 when the NY Times gave us: “Eight major companies, led by Google and Microsoft, are calling for tighter controls on surveillance of their customers’ data by governments“, yet the opposite was never put in place, the existence of Cambridge Analytics, the application of selling consumer data as well as the abuse of data collection through apps has never been stopped. We get all kinds of options to market through mined data giving a larger rise to corporatocracy, whilst the media remains silent on the dangers of corporatocracy. So when we see ‘This is what happens when corporations run the government‘ (Washington Post, March 2019) and ‘Australia’s march towards corporatocracy‘ (the conversation Feb 2017) we see merely two mentions on Google search page one, whilst he situation set the stage that there should have been dozen of clear mentions and investigations, yet the media seemingly have almost zero mentions, how is that? I think that there is a clear stage where corporations do not want to see any mention if possible and as I mentioned earlier ‘in the listing from government, through corporations to media to the viewer, we forget that there are three iterations of information, all bound by their own personal issues‘, and here we see how ‘through corporations to the media‘ is directly inhibiting exposure. The Balance of Power would be an awesome game if we can incorporate it into a new game, especially when we see how the media and corporations make sure that a lot of the information will not be shown, active censorship in nations that proclaim freedom of speech and freedom of expression, when you own the printing house you get to tell the people what they care about, we apparently forgot about that small part again and again.

It is the beginning of a rigged game where the next generation gets to pay for the screw ups of the current generation, feel free to ignore or deny that, yet when we consider the US with a debt of $21 trillion, the EU has around € 10.1 trillion and on a global scale we see that the Global debt had reached an all-time high of $184 trillion in January 2019, we see that the Balance of Power is a term that has become debatable, a stage where banks are basically in charge, limiting or directing the options that any government is allowed to consider. The original game never anticipated that reality, but there you have it. John Perkins tried to inform the audience with ‘Confessions of an Economic Hit Man (2004)’, yet even after Berrett-Koehler published it, gaining an instant bestseller, whilst the major U.S. media refused to discuss Confessions or the fact that, because of it, terms such as “EHM” and “corporatocracy” were now appearing on college syllabi. A stage where the media claiming to advocate freedom of speech, whilst we see that its absence is allegedly corporation controlled, a direct (still alleged) piece of evidence showing that whatever balance of Power we envision, when it is set to nations and governments we get less than 50% of the players in view, making a larger injustice to the people.

In this, I wonder who exactly the real monsters are; are they identified by the acts of nations like Turkey, Iran and North Korea, are they the acts by organisations like ISIS, Hezbollah and Hamas, or are the corporations and the media they control a lot less innocent in all this. Will the next generation be ready for what we, the current generation have facilitated for?

I honestly do not know.

 

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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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Mental health or Medication

We have seen the premise in a few stages in the last decade and for the most people lean towards one or the other and that is fine, it is a hard choice to make and there is no real evidence which of the two is better in the long run. Mental health needs treatment, medication is at times not a cure, merely a way to create a timeline for treatment, or to minimise the impact of the situation. Yet there is also a medial state that is not mental health based, for example treating people with cystic fibrosis who have two copies of the F508del mutation, for them there is Orkambi. Yet, what is the status when this involves a politician? How delusional is a public speaker allowed to become before he is considered unhealthy and unable to perform his function?

That question came up when the Guardian gave me ‘Labour pledges to break patents and offer latest drugs on NHS‘ (at https://www.theguardian.com/politics/2019/sep/24/labour-pledges-to-break-patents-and-offer-latest-drugs-on-nhs). So not only is he making claims, he is basically pronouncing war on the World Trade Organisation, abolishing the TRIPS agreement and throwing it all overboard. As we realise that the World Health Organisation gives us: “As of February 2005, 148 countries are Members of the WTO. In becoming Members of the WTO, countries undertake to adhere to the 18 specific agreements annexed to the Agreement establishing the WTO. They cannot choose to be party to some agreements but not others“, the UK and the EU are both signatories, so Jeremy Corbyn is stupid enough to set a stage of war that endangers millions. To give a little consideration to the metrics, we get the numbers on Cystic Fibrosis, not merely those with these two mutations (a specific subset), we see that more than 70,000 people worldwide are living with cystic fibrosis. Approximately 1,000 new cases of CF are diagnosed each year. More than 75 percent of people with CF are diagnosed by age 2. More than half of the CF population is age 18 or older. Now this is not a good thing, we admit, yet we are looking to a population that is less than 0.001% of the entire population, more important the people that need Orkambi are a mere subset of that. And for the UK it would linearly mean that it affects only 0.1% of the 0.001% that optionally have it. That is his ‘limelight’; can someone please kick this idiot out of the Labour party (preferably out of UK politics altogether)?

And in the second part, no political party has any business being in the pharmaceutical industry, there is a reason why industrials should never have any political power (well, we lost that one ages ago, but still). His voice giving us: ‘party will create company to make cheap versions of drugs‘, whilst the metrics give us that it will be a population less than a 100 that have this version of Cystic Fibrosis that is what he is fighting for? He cannot even properly represent his constituency and now he is starting patent wars as well as a war with the World Trade Organisation on abolishing or severely changing The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)? Not only does it not make sense, the impact could be devastating for the UK. This is a person screaming ‘election’ and then spinning silent when it was offered.

It is my personal view that UK labour is better off getting the clown Ronald McDonald to do the Labour party bidding, and it will do a better job than Jeremy Corbyn ever could. His promises are no longer empty, they are now right-out dangerous.

Pharmaceuticals

There is a larger pharmaceutical issue and it has been going on for well over a decade, the issue that patents are reapplied well over 30 years after date, often in a slightly changed form, only barely passing the innovation line is the largest concern for generic medication, yet there are dozens of examples and Orkambi is nowhere near the top 10 in this. Lyrica (Pfizer), Rituxan (roche), Cialis (Eli Lilly), Xolair (Roche/Novartis), Restatis (Allergan) are 5 of the top 10 expiring patents with a value of a little over $16 billion in total, and those owners would like a little longer exclusivity, because the expiration will hit their bottom line in a real hard way. In that list Orkambi does not even stack up to any decent degree and we have larger issues gaining patents with a generic option and Corbyn’s need to make war with TRIPS, whilst the NHS has larger issues, especially as it was Labour who botched the NHS IT project losing £11 billion and small change to the degree of several millions is not one who should be casting voices on ending patents.

The sentiment is not wrong, but the chosen field is a little beyond stupid, making us wonder whether the man is personally dealing with mental health issues. We all have had that moment where we wanted to stand in front of Dwayne Johnson calling him Tinkerbell, not really wise, but we all have those inflated moments of self, to do what Jeremy Corbyn does worse hiding behind one 9 year old with: “Luis is denied the medicine he needs because its American manufacturer refuses to sell the drug to the NHS for an affordable price“, so this is not some Cystic Fibrosis case, this is a very specific case and the medication required many millions to create and pass FDA approval. A medication for CF patients with a rare mutation. With two specific mutations in a disease that knows more than 1,700 mutations that had been found in the CFTR gene. Orkambi works for patients with the F508del mutation in both copies the CFTR gene, the most common mutation in people with cystic fibrosis worldwide. So even if it is the most common, there are 1700 mutations meaning that his war on one medication to a specific subset that comes down to a lot less than 100 patients in the UK. So this idiot (read: Jeremy Corbyn) goes to war, promising to abolish TRIPS and leaving the WTO, all for a subset of people, too small to fill a village? Now consider that the UK has Pharmaceutical interests as well, the top two players in the UK are GlaxoSmithKline and AstraZeneca representing almost £132 billion pounds, because if he does what he does, then those two will vacate as well, this is how stupid Jeremy Corbyn is, but he is hoping that you will not notice this as he is in feigned tears for one nine year old child. I only mentioned the top two, the field is larger than that, but Jeremy Corbyn is willing to throw it all in the air.

Can you please explain to me how the government budget will be met when two companies representing a taxable £100,000,000,000 leave the UK? This is the kind of short-sighted, BS carrying ventures that Jeremy Corbyn is handing its constituents. His claim is ‘In England about 5,000 young patients could benefit, but the NHS said it could not afford to pay the bill‘, if there are worldwide 70,000 Cystic Fibrosis (CF) patients the UK cannot have that many, the claim of “US drugs company Vertex priced Orkambi at over £100,000 per patient per year” might be true and for 100 patients that is still serious money, but we need to recognise that we cannot hand every working person a Ferrari, we do not have the money, and it is that extreme. We are in a position where until a patent ends, the maker gets to set the price, or not sell the product. In light of the numbers I see, I want Jeremy Corbyn to give us an exact list of these 5,000 patients and what medication they need. I reckon that the picture shifts a lot faster at that point. And we agree that larger changes are required, yet making a direct case to the WTO that patents cannot be extended above the 35 years is a lot better than abolishing the WTO. Yet Jeremy Corbyn has no options to do that, so he comes with a delusional plan to start a company that ‘create company to make cheap versions of drugs‘, whilst there are plenty of companies doing that, the case remains that patents hand exclusivity until they expire, this year 26 drugs are facing patent expiration and yet, Orkambi is not among them, but 26 patents will become generic, before 2022 42 patents will expire and that is good for a lot of people, yet this system is already in place, we do not need some delusional politician to add his need to become a rich pharmaceutical cat as well.

To be honest, I have never had such a low regard of UK Labour ever before, the fact that I have twice the regard towards LibDems than towards Labour at present is something I never thought possible in the age of Ed Miliband, whomever thought that Corbyn would be a worthy successor deserved the title ‘Joker of the Year‘, as I personally see it, it is actually that bad at present.

So whomever is happy that this optional mental health case is running the UK labour party is in desperate need of some medication (generic NHS funded options will be available).

 

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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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Go cry me a river

OK, at times it is important to keep a moral foundation towards the actions we take. Some people (the non-Germans) were hesitant to be named a recipient by Adolf Hitler. There are Africans that did not consider accepting any honours from Idi Amin Dada; there was opposition by some towards the grants from Muammar Al Gadhafi, even if he looked like Jeffrey Ross. Many have been in a place where question marks are held high. Yet I think that we have taken the left to a whole new level (of stupidity) when we see: ‘Austerity forcing arts institutions to accept gifts from billionaires‘ (at https://www.theguardian.com/culture/2019/mar/22/austerity-forcing-arts-institutions-to-accept-gifts-from-billionaires). The setting here is: “More than £100m of government cuts to annual arts funding has forced the nation’s top art galleries, theatres and opera houses to accept gifts from billionaires, including the controversial Sackler family, which made a fortune from the deadly opioid painkiller crisis“, I am not in a financial happy place, so when the Sackler family gives me a £5 million grant, I will bow, smile and say “Thank you very much!” You see, the question is not what their morality allowed for, the question becomes, were criminal acts done?

It is important to take another look at https://www.theguardian.com/us-news/2019/mar/21/sackler-family-500-cities-counties-and-tribes-sue-oxycontin-maker, where we are introduced to: ‘Massive lawsuit says Sackler family broke laws to profit from opioids‘, even as we see the word ‘lawsuit’, that does not imply that the law was broken. There we see: “accusing members of the Sackler family, who own the maker of the opioid painkiller OxyContin, of helping to create “the worst drug crisis in American history”“. I am also very aware of the state of accusation that is given with: “Court documents accuse the eight family members of purposely playing down the dangers of the prescription painkiller OxyContin, which is more potent than heroin or morphine. They are accused of deceiving doctors and patients and directing sales and marketing techniques that drove huge over-prescribing and ever stronger doses for many patients who should never have been prescribed the pills in the first place“. In that text the two words that matter are swept under the carpet. The part ‘prescription painkiller‘ is at the centre of that part and there we see a clear shift. In this he first issue becomes the GP, or medical professional that prescribed the painkiller in the first place. Then we get the FDA (the US Food and Drug Administration) who should have put an initial stop to the issue if there was one. Was this done? As we now see the claims like ‘House Democrats Want More Information On Sackler Family’s Role In Opioid Epidemic‘, and a whole range of other accusations, we need to take a larger look. The FDA gives the direct part: “Get emergency help right away if you take too much OXYCONTIN (overdose). When you first start taking OXYCONTIN, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Never give anyone else your OXYCONTIN. They could die from taking it. Store OXYCONTIN away from children and in a safe place to prevent stealing or abuse. Selling or giving away OXYCONTIN is against the law.

In addition we find information like: “Oxycodone is used for managing moderate to severe acute or chronic pain when other treatments are not sufficient.” again we see ‘when other treatments are not sufficient‘, now we see the crying of a collection of bitches whilst the direct investigation on these patients has optionally not been done. When we look at the history of these people and to what was initially prescribed we are likely to find a whole range of crying whiners who shouted and screamed for the strongest painkillers neglecting other alternatives, I feel certain that with all the data I would be able to find well over 10% failing the case from the very start. There is documentation on OxyContin going back to 1996, and NOW we see an optional case? 22 years later? I believe that there is a much larger issue in play. I believe that responsible parties have given in towards whining patients for decades, so is the Sackler family to blame for any of that? I do not believe that to be the case.

In addition we see: “Among the eight Native American tribes suing the Sacklers are parts of the Cherokee, the Chippewa and the Sioux, the Oneida Nation and the Blackfeet. Drug overdoses now kill more than 72,000 people in the US a year, according to government figures from the Centers for Disease Control and Prevention, and 49,000 of those are caused by opioids.” We see the facts, yet who prescribed these drugs? The direct and simplest of questions and none of the articles give a correct or decent answer, the direct application of the failing of the Unites States through lawsuits that will not go anywhere ever. I am decently certain that when the doctors are called to testify and they describe the harassing and badgering patients that needed more and more and stronger painkillers, we will see a prescription failure to a much larger degree. In this light it is important to take the Native American Tribes into view as well. From my point of view there is a whole different range into the need of medication between rural (Native American or not) and metropolitan medication needs. That too must be taken into account. In addition, such an overload of opioids also puts the pharmacies into view. They have a duty to report such an increase of prescribed of opioids, as well as the physicians prescribing them. I will give you one better, the TV show Lou Grant (1978-1982) actually had one episode focused on that issue, an issue before OxyContin was in existence. A systemic failure brought into the limelight by a TV series and well over 13 years before there was OxyContin, so at this point, is there a clear directive to take a much larger view before you merely throw your lawsuit needy fingers towards the Sackler family?

And the clear part is that I am not stating that they are innocent, I am showing that there are at least three iterations of optionally guilty parties and involved players that should find themselves defending their actions in the courts before there is even a remote chance to have a go at the Sackler family and the FDA might be in court long before the Sackler members are.

So whilst you want to have a go at la dottore Raymond Sackler, be aware that those trying to make that jump will lose funds and cash by not doing their homework form day one and it took me a mere 187 seconds to realise that after these two articles were read. The biggest part is seen with: “This nation is facing an unprecedented opioid addiction epidemic that was initiated and perpetuated by the Sackler defendants for their own financial gain, to the detriment of each of the plaintiffs and their residents. The ‘Sackler defendants’ include Richard Sackler, Beverly Sackler, David Sackler, Ilene Sackler Lefcourt, Jonathan Sackler, Kathe Sackler, Mortimer DA Sackler, and Theresa Sackler,” this week’s lawsuit states“, no mention of the FDA approval, no list of hundreds of physicians prescribing the substance and no mention of a properly investigated medical history of the victims, all that got the limelight from the mere mention of ‘prescription painkiller‘. The fact that a TV Series like Lou Grant took an episode to show the failing of some physicians in such a situation was merely the icing on the cake called: “Laughingly created Court failure“.

As stated, I am not stating that they are guilty, not merely as they are presumed innocent, especially in light of the failed required elements in all this, the fact that some articles are loaded with emotion absent of 22 years of evidence that never required to await the court date is the added bonus that makes this all an optional failure, the application of common sense wins again!

In addition, consider the quote: “Court documents accuse the eight family members of purposely playing down the dangers of the prescription painkiller OxyContin, which is more potent than heroin or morphine“, yet I see no mention or any accusations towards the FDA, are they not the authority that people should turn to? Where were they in all this? Where are the approving physicians in all this? All direct questions, all without any answers. So when we consider the statement: “Drug overdoses now kill more than 72,000 people in the US a year, according to government figures from the Centers for Disease Control and Prevention, and 49,000 of those are caused by opioids.” How many of those are merely junkies looking for a fix? How many were due to illegally obtained drugs and painkillers? I wonder what remains of these numbers when we take a deeper look at that part of the data cake sliced on those influencing factors. When we do that those numbers might dwindle down for up to 80% making this a non-case and a non-event from the very beginning.

Good luck to those who shout: ‘prosecute’ whilst ignoring common sense of the matter at hand.

 

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When the trust is gone

In an age where we see an abundance of political issues, an overgrowing need to sort things out, the news that was given visibility by the Guardian is the one that scared and scarred me the most. With ‘Lack of trust in health department could derail blood contamination inquiry‘ (at https://www.theguardian.com/society/2017/jul/19/lack-of-trust-in-health-department-could-derail-blood-contamination-inquiry), we need to hold in the first stage a very different sitting in the House of Lords. You see, the issues (as I am about to explain them), did not start overnight. In this I am implying that a sitting with in the dock Jeremy Hunt, Andrew Lansley, Andy Burham and Alan Johnson is required. This is an issue that has grown from both sides of the Isle and as such there needs to be a grilling where certain people are likely to get burned for sure. How bad? That needs to be ascertained and it needs to be done as per immediate. When you see “The contamination took place in the 1970s and 80s, and the government started paying those affected more than 25 years ago” the UK is about to get a fallout of a very different nature. We agree that this is the term that was with Richard Crossman, Sir Keith Joseph, Barbara Castle, David Ennals, Patrick Jenkin, Norman Fowler, and John Moore. Yet in that instance we need to realise that this was in an age that was pre computers, pre certain data considerations and a whole league of other measures that are common place at this very instance. I remember how I aided departments with an automated document system, relying on 5.25″ floppy’s, with the capability that was less than Wordstar or PC-Write had ever offered. And none of those systems had any reliable data storage options.

The System/36 was flexible and powerful for its time:

  • It allowed 80 monitors (see below for IBM’s description of a monitor) and printers to be connected. All users could access the system’s hard drive or any printer.
  • It provided password security and resource security, allowing control over who was allowed to access any program or file.
  • Devices could be as far as a mile from the system unit.
  • Users could dial into a System/36 from anywhere in the world and get a 9600 baud connection (which was very fast in the 1980s) and very responsive for connections which used only screen text and no graphics.
  • It allowed the creation of databases of very large size. It supported up to about 8 million records, and the largest 5360 with four hard drives in its extended cabinet could hold 1.453 gigabytes.
  • The S/36 was regarded as “bulletproof” for its ability to run many months between reboots (IPLs).

Now, why am I going to this specific system, as the precise issues were not yet known? You see in those days, any serious level of data competency was pretty much limited to IBM, at that time Hewlett Packard was not yet to the level it became 4 years later and the Digital Equipment Corporation (DEC) who revolutionised systems with VAX/VMS and it became the foundation, or better stated true relational database foundations were added through Oracle Rdb (1984), which would actually revolutionise levels of data collection.

Now, we get two separate quotes (not from the article) “Dr Jeremy Bradshaw Smith at Ottery St Mary health centre, which, in 1975, became the first paperless computerised general practice“, as well as “It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use“, the second one comes from the Oracle Rdb SQL Reference manual. The second part seems a bit of a stretch; consider the original setting of this. When we see Oracle’s setting of data integrity, consider the elements given (over time) that are now commonplace.

System and object privileges control access to application tables and system commands, so that only authorized users can change data.

  • Referential integrity is the ability to maintain valid relationships between values in the database, according to rules that have been defined.
  • A database must be protected against viruses designed to corrupt the data.

I left one element out for the mere logical reasons.

now, in those days, the hierarchy of supervisors and system owners was nowhere near what it is now (and often nowhere to be seen), referential integrity was a mere concept and data viruses were mostly academic, that is until we get a small presentation by Ralf Burger in 1986. It was in the days of the Chaos Computer Club and my trusty CBM-64.

These elements are to show you that data integrity existed in academic purposes, yet the designers who were in their data infancy often enough had no real concept of rollback data events, some would only be designed too long later, and in all this, the application of databases to the extent that was needed. It would not be until 1982 when dBase II came to the PC market from the founding fathers of what would later be known as Ashton-Tate, George Tate and Hal Lashlee would create a wave that would get us dBase III and with the creation of Clipper by the Nantucket Corporation, which would give a massive rise to database creations as well as the growth of data products that had never been seen before, as well as being the player that in the end propelled data quality towards the state it is nowadays. In this product databases did not just grow with the network abilities within this product nearly any final year IT person could have its portfolio of clients all with custom based products all data based. Within 2-3 years (which gets us to 1989), a whole league of data quality, data cleaning and data integrity base issues would surface for millions of places, all requiring solutions. It is my personal conviction that this was the point where data became adult, where data cleaning, data rollback as well as data integrity checks became actual issues that were seriously dealt with. So, here in 1989 we are finally confronted with the adult data issues that for the longest of times were only correctly understood by more than a few niche people who were often enough disregarded (I know that for certain because I was one of them).

So the essential events that could have prevented only to some degree the events we see in the Guardian with “survivors initially welcomed the announcement, while expressing frustration that the decades-long wait for answers had been too long. The contamination took place in the 1970s and 80s“, certain elements would not come into existence until a decade later.

So when we see “Liz Carroll, chief executive of the Haemophilia Society, wrote to May on Wednesday saying the department must not be involved in setting the remit and powers of an inquiry investigating its ministers and officials. She also highlighted the fact that key campaigners and individuals affected by the scandal had not been invited to the meeting“, I am not debating or opposing her in what could be a valid approach, I am merely stating that to comprehend the issues, the House of Lords needs to take the pulse of events and the taken steps forward from the Ministers who have been involved in the last 10 years.

When we see “We and our members universally reject meeting with the Department of Health as they are an implicated party. We do not believe that the DH should be allowed to direct or have any involvement into an investigation into themselves, other than giving evidence. The handling of this inquiry must be immediately transferred elsewhere“, we see a valid argument given, yet when we would receive testimonies from people, like the ministers in those days, how many would be aware and comprehend the data issues that were not even decently comprehended in those days? Because these data issues are clearly part of all of these events, they will become clear towards the end of the article.

Now, be aware, I am not giving some kind of a free pass, or give rise that those who got the bad blood should be trivialised or ignored or even set to a side track, I am merely calling for a good and clear path that allows for complete comprehension and for the subsequent need of actual prevention. You see, what happens today might be better, yet can we prevent this from ever happening again? In this I have to make a side step to a non-journalistic source, we see (at https://www.factor8scandal.uk/about-factor/), “It is often misreported that these treatments were “Blood Transfusions”. Not True. Factor was a processed pharmaceutical product (pictured)“, so when I see the Guardian making the same bloody mistake, as shown in the article, we see and should ask certain parties how they could remain in that same stance of utter criminal negligence (as I personally see it), but giving rise to intentional misrepresentation. When we see the quote (source: the Express) “Now, in the face of overwhelming evidence presented by Andy Burnham last month, Theresa May has still not ordered an inquiry into the culture, practice and ethics of the Department of Health in dealing with this human tragedy” with the added realisation that we have to face that the actual culprit was not merely data, yet the existence of the cause through Factor VIII is not even mentioned, the Guardian steered clear via the quote “A recent parliamentary report found around 7,500 patients were infected by imported blood products from commercial organisations in the US” and in addition the quote “The UK Public Health Minister, Caroline Flint, has said: “We are aware that during the 1970s and 80s blood products were sourced from US prisoners” and the UK Haemophilia Society has called for a Public Inquiry. The UK Government maintains that the Government of the day had acted in good faith and without the blood products many patients would have died. In a letter to Lord Jenkin of Roding the Chief Executive of the National Health Service (NHS) informed Lord Jenkin that most files on contaminated NHS blood products which infected people with HIV and hepatitis C had unfortunately been destroyed ‘in error’. Fortunately, copies that were taken by legal entities in the UK at the time of previous litigation may mean the documentation can be retrieved and consequently assessed“, the sources the Express and the New York Times, we see for example the quote “Cutter Biological, introduced its safer medicine in late February 1984 as evidence mounted that the earlier version was infecting hemophiliacs with H.I.V. Yet for over a year, the company continued to sell the old medicine overseas, prompting a United States regulator to accuse Cutter of breaking its promise to stop selling the product” with the additional “Cutter officials were trying to avoid being stuck with large stores of a product that was proving increasingly unmarketable in the United States and Europe“, so how often did we see the mention of ‘Cutter Biological‘ (or Bayer pharmaceuticals for that matter)?

In the entire Arkansas Prison part we see that there are connections to cases of criminal negligence in Canada 2006 (where Canadian Red Cross fell on their sword), Japan 2007 as well as the visibility of the entire issue at Slamdance 2005, so as we see the rise of inquiries, how many have truly investigated the links between these people and how the connection to Bayer pharmaceuticals kept them out of harm’s way for the longest of times? How many people at Cutter Biological have not merely been investigated, but also indicted for murder? When we get ‘trying to avoid being stuck with large stores of a non-sellable product‘ we get the proven issue of intent. Because there are no recall and destroy actions, were there?

Even as we see a batch of sources giving us parts in this year, the entire visibility from 2005-2017 shows that the media has given no, or at best dubious visibility in all this, even yesterday’s article at the Guardian shows the continuation of bad visibility with the blood packs. So when we look (at http://www.kpbs.org/news/2011/aug/04/bad-blood-cautionary-tale/), and see the August 2011 part with “This “miracle” product was considered so beneficial that it was approved by the FDA despite known risks of viral contamination, including the near-certainty of infection with hepatitis“, we wonder how the wonder drug got to be or remain on the market. Now, there is a fair defence that some issues would be unknown or even untested to some degree, yet the ‘the near-certainty of infection with hepatitis‘ should give rise to all kinds of questions and it is not the first time that the FDA is seen to approve bad medication, which gives rise to the question why they are allowed to be the cartel of approval as big bucks is the gateway through their door. When we consider the additional quote of “By the time the medication was pulled from the market in 1985, 10,000 hemophiliacs had been infected with HIV, and 15,000 with hepatitis C; causing the worst medical disaster in U.S. history“, how come that it took 6 years for this to get decent amounts of traction within the UK government.

What happened to all that data?

You see, this is not merely about the events, I believe that if any old systems (a very unlikely reality) could be retrieved, how long would it take for digital forensics to find in the erased (not overwritten) records to show that certain matters could have been found in these very early records? Especially when we consider the infancy of data integrity and data cleaning, what other evidence could have surfaced? In all this, no matter how we dig in places like the BBC and other places, we see a massive lack of visibility on Bayer Pharmaceuticals. So when we look (at http://pharma.bayer.com/en/innovation-partnering/research-focus/hemophilia/), we might accept that the product has been corrected, yet their own site gives us “the missing clotting factor is replaced by a ‘recombinant factor’, which is manufactured using genetically modified mammalian cells. When administered intravenously, the recombinant factor helps to stop acute bleeding at an early stage or may prevent it altogether by regular prophylaxis. The recombinant factor VIII developed by Bayer for treating hemophilia A was one of the first products of its kind. It was launched in 1993“, so was this solution based on the evolution of getting thousands of people killed? the sideline “Since the mid-1970s Bayer has engaged in research in haematology focusing its efforts on developing new treatment options for the therapy of haemophilia A (factor VIII deficiency)“, so in all this, whether valid or not (depending on the link between Bayer Pharmaceuticals UK and Cutter Biological. the mere visibility on these two missing in all the mentions, is a matter of additional questions, especially as Bayer became the owner of it all between 1974 and 1978, which puts them clearly in the required crosshairs of certain activities like depleting bad medication stockpiles. Again, not too much being shown in the several news articles I was reading. When we see the Independent, we see ‘Health Secretary Jeremy Hunt to meet victims’ families before form of inquiry is decided‘, in this case it seems a little far-fetched that the presentation by Andy Burham (as given in the Express) would not have been enough to give an immediate green light to all this. Even as the independent is hiding behind blood bags as well, they do give the caption of Factor VIII with it, yet we see no mention of Bayer or Cutter, yet there is a mention of ‘prisoners‘ and the fact that their blood was paid for, yet no mention of the events in Canada and Japan, two instances that gives rise to an immediate and essential need for an inquiry.

In all this, we need to realise that no matter how deep the inquiry goes, the amount of evidence that could have been wiped or set asunder from the eyes of the people by the administrative gods of Information Technology as it was between 1975 and 1989, there is a dangerous situation. One that came unwillingly through the evolution of data systems, one that seems to be the intent of the reporting media as we see the utter absence of Bayer Pharmaceuticals in all of this, whilst there is a growing pool of evidence through documentaries, ad other sources that seem to lose visibility as the media is growing a view of presentations that are skating on the subject, yet until the inquiry becomes an official part we see a lot less than the people are entitled to, so is that another instance of the ethical chapters of the Leveson inquiry? And when this inquiry becomes an actuality, what questions will we see absent or sidelined?

All this gets me back to the Guardian article as we see “The threat to the inquiry comes only a week after May ordered a full investigation into how contaminated blood transfusions infected thousands of people with hepatitis C and HIV“, so how about the events from 2005 onwards? Were they mere pharmaceutical chopped liver? In the linked ‘Theresa May orders contaminated blood scandal inquiry‘ article there was no mention of Factor VIII, Bayer (pharmaceuticals) or Cutter (biological). It seems that we need to give rise that ethical issues have been trampled on, so a mention of “a criminal cover-up on an industrial scale” is not a mere indication; it is an almost given certainty. In all that, as the inquiry will get traction, I wonder how both the current and past governments will be adamant to avoid skating into certain realms of the events (like naming the commercial players), and when we realise this, will there be any justice to the victims, especially when the data systems of those days have been out of time for some time and the legislation on legacy data is pretty much non-existent. When the end balance is given, in (as I personally see it) a requirement of considering to replace whatever Bayer Pharmaceuticals is supplying the UK NHS, I will wonder who will be required to fall on the virtual sword of non-accountability. The mere reason being that when we see (at http://www.annualreport2016.bayer.com/) that Bayer is approaching a revenue of 47 billion (€ 46,769M) in 2016, should there not be a consequence of the players ‘depleting unsellable stock‘ at the expense of thousands of lives? This is another matter that is interestingly absent from the entire UK press cycles. And this is not me just speculating, the sources give clear absence whilst the FDA reports show other levels of failing, it seems that some players forget that lots of data is now globally available which seems to fuel the mention of ‘criminal negligence‘.

So you have a nice day and when you see the next news cycle with bad blood, showing blood bags and making no mention of Factor VIII, or the pharmaceutical players clearly connected to all this, you just wonder who is doing the job for these journalists, because the data as it needed to be shown, was easily found in the most open of UK and US governmental places.

 

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The other side of sickness

Sky News gave me the idea last night. I was half awake (hence: half asleep) when the news (at http://news.sky.com/story/de-niro-offers-100k-reward-to-media-for-truth-about-controversial-childrens-vaccine-10771445), when de news stating ‘De Niro offers $100k reward‘ became visible. When I woke up completely (a few hours later), I saw the full Monty: “De Niro offers $100k reward to media for ‘truth’ about controversial children’s vaccine“, which was a little more descriptive. Now I am not media, but I have decided to take a look at it. First off, it is never a good idea to meet your idol when he is still alive, but I think Robert got through it OK. What more is there on the article?

The first part is “willing to publicise criticism of a controversial children’s vaccine“, which is an odd start, so the important part is Thimerosal, which is the medication part that needs to be scrutinised. The other part we get is “a substance containing mercury, in the generalised MMR vaccine, which protects children against measles, mumps and rubella“, now we are off to the races. You see, Mercury is toxic, so is Arsenic. Yet Arsenic was used in the past as a treatment (in very small doses) against Syphilis. It is not the only example. In small doses it is used against Osteoarthritis, which contains a substance that got someone ‘accidently’ poisoned to death in the 60’s, yet in those days Boron (the substance in question) was not tested for, because the body will have it. It is merely the concentration that took care of the non-breathing part in the end.

So what is the story with Thimerosal? Let’s start at the beginning.

last_case_07Vaccines go all the way back to 1798 (roughly) when a man named Edward Jenner decided to pioneer a solution against Smallpox. The solution he came up with was to infect a person with the cow version of the disease so that the human body would see the weaker version as a threat and the body would be fast and more effective fighting the actual disease. So I grew up in the 60’s getting all kinds of vaccines and injections, the conclusion in my case was that I have had no real dangerous diseases for well over 35 years. The World Health Organisation proclaimed that after vaccination campaigns throughout the 19th and 20th centuries, the WHO certified the global eradication of smallpox in 1979.

So vaccines are seen as a good thing, so what changed our minds?

There are a few issues that have grown that give voice to the anti-vaccination feelings. Yet, there is documentation out in the open showing exactly the opposite. I witnessed this in the Netherlands (at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4914a2.htm), in the time frame between April 1999 and January 2000, which gives us the quote “a cluster of five cases of measles was reported among the 390 students attending a religion-affiliated elementary school in the Netherlands. Persons belonging to this religious denomination routinely do not accept vaccination. Municipal health services (MHSs) investigated and found 160 suspected measles cases among children attending the school. By February 4, 2000, 2961 measles cases, including three measles-related deaths, had been reported by 35 MHSs to the national registry. This report summarizes the investigation of the measles outbreak in the Netherlands, which indicated that measles can be a severe disease among unvaccinated populations in the Netherlands“. This alone should clearly show the essential support for vaccines.

Yet now we see the second element in this. You see, the population on a global scale is getting wearier and less trusting of vaccines. It is a $26 billion market and is expected to grow to $61 billion in the next 3 years. We are confronted with flu vaccines and there is no clear proof or documentation that they are actually a benefit. Even as the 60’s were a clear indication that the foundation of vaccines was sound and essential, the movement of big pharma and the essential need for profit has given vaccines the place where it potentially leaves too bad a taste in the mouths of too many people. This is the place where Thimerosal finds itself in. Mistrusted because of the makers and mistrusted due to a lack of proper information and in similar size the massive misinformation that we now see on the lack of benefits that other medications (like Multi vitamins) find themselves in, and to some extent, the media has been too often, little to no help at all. To a larger extent, they are chasing facts, or not showing the dangers ahead of time in too many cases. At http://www.globalresearch.ca/big-pharma-and-big-profits-the-multibillion-dollar-vaccine-market/5503945, the Canadian Centre for Research on Globalization (CRG) gives us “While the main fixation of anti-vaccine groups is an old, discredited study linking vaccination to autism, another is a conspiracy theory circulated online that both doctors and pharmaceutical companies stand to profit financially from vaccination—which supposedly leads to perverse incentives in advocating for the public to vaccinate. But that argument is historically unfounded. Not only do pediatricians and doctors often lose money on vaccine administration, it wasn’t too long ago that the vaccine industry was struggling with slim profit margins and shortages. The Economist wrote that “for decades vaccines were a neglected corner of the drugs business, with old technology, little investment and abysmal profit margins. Many firms sold their vaccine divisions to concentrate on more profitable drugs“, at this point I offer in opposition, if that was true, why would there be a sudden rush to get into vaccines? If certain diseases have been eradicated, would the need for vaccines not decrease? If the flu cannot be cured through vaccines, what is its benefit? Two question that have not been properly addressed ever. The press have remained on the surface too often and too long. There is too much profit in advertisements for the media, too many concessions and the people notice, the people at large deduce their own wisdom and facts in what they see. Are they wrong?

What is Thimerosal?

The National Centre for Immunisation Research & Surveillance (NCIRS) gives the following Factsheet where we see “There is no evidence that thiomersal in vaccines has caused any health problems except minor reactions, such as redness at the injection site“, another fact shown, a part that seems to be ignored in a few points of visibility. It is “Methyl mercury is more potent; it accumulates in the body because the time taken for the body to eliminate it (known as the ‘half-life’) is about 50 days. Ethyl mercury (in thiomersal) does not accumulate in the body to such an extent, because its half-life is only about 7–10 days“, the dangerous side I was aware of, or the danger I perceived is not a factor here.

  • Thimerosal is also known as thiomersal, hence the quotes from different sources have these two names.

Now we get the issue that is also a cause for concern and it is not the controversial accusation of autism. The issue is that if we accept the initial fact, then why are we given “the American Academy of Paediatrics (AAP) asked vaccine makers to remove thiomersal from vaccines as quickly as possible as a precautionary measure“, when we look (at http://pediatrics.aappublications.org/content/131/1/149) the quote “Overwhelmingly, the evidence collected over the past 15 years has failed to yield any evidence of significant harm, including serious neurodevelopmental disorders, from use of thimerosal in vaccines“, personally I would love to see that data! There is also “Dozens of studies from countries around the world have supported the safety of thimerosal-containing vaccines. Specifically, the Institute of Medicine, and others have concluded that the evidence favours rejection of a link between thimerosal and autism“. The AAP publications show 7 links to academic papers confirming this.

There is also: “Although there are clear neurotoxic effects of methyl mercury absorption, ethyl mercury has not been associated with those consequences“, so one mercury is not another, yet how deep has this been investigated? As we see that ethyl mercury might have been a massive push for the profitability that vaccines became, there is still the question on the need for vaccines. I am not debating that the larger good exist, that evidence was given in the Netherlands, a place where Measles suddenly resurfaced, in a place where vaccination was rejected on religious reasons. As we reject ‘en mass’ to a larger extent on flu-vaccines and on the pharmaceuticals that need too much profit and as it is seen by many at the expense of them all.

Projection, publication against the interpreted fear and rejection through despise of the pharmaceutical community.

Yet in all this thimerosal is just an element, the actual vaccine in all this is the MMR vaccine. Robert De Niro did not oppose the MMR vaccine, just the use of thimerosal. When it comes to vaccines, there is one paper that does have an impact. It is a paper by Ami Schattner published in 2005 called ‘Consequence or coincidence?: The occurrence, pathogenesis and significance of autoimmune manifestations after viral vaccines‘, which could be seen as alarming (at http://www.sciencedirect.com/science/article/pii/S0264410X05003506) giving us “Very few patients may develop some autoimmune diseases following viral vaccination (in particular — arthropathy, vasculitis, neurological dysfunction and thrombocytopenia). For the overwhelming majority of people, vaccines are safe and no evidence linking viral vaccines with type 1 diabetes, multiple sclerosis (MS) or inflammatory bowel disease can be found“, with the emphasis on “The occurrence and significance of autoimmune manifestations after the administration of viral vaccines remain controversial“. Now, if you picked up on it, you will state that Autism is not an autoimmune disease, then you are right. Now for my speculation in this part, if the creation of a Immune system disorders is rare, I am speculating that the creation of autism through vaccination is even more rare than that. A vaccine is the introduction of a disease to the body, so the immune system is actually directly attacked. If that does not abnormally react, the consideration that another disease like Autism, which is a neuro developmental disorder seems extremely unlikely unless the vaccine was specifically for a neuro based disease, and at present it seems less and less likely that it is the case.

An escalation that we are confronted with all due to a fraudulent paper from Andrew Wakefield et al, who decided that 1998 was a good year to misrepresent facts and opposing the MMR vaccine in support of a competing vaccine. It would be my speculated assumption that greed got in the way of his better angels and more likely than not, to an even larger extent by that competing brand as well. It is that competitive approach, with support of a former academic that the mistrust has grown in the people, especially the parents on a global scale. There it is that we find thimerosal, removed in many places as a mere precaution. That against a large supported foundation that thimerosal is not dangerous. So does this make the view of Robert De Niro incorrect?

No!

I believe that he is asking valid question, in addition, let it be sad that his view as stated: ‘he just wants a safer way to prevent diseases‘ is a noble one, especially in an age where the profit needs are pushed through too often and too fast. Procon.org gives us (at http://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528) a list of 35 FDA approved drugs that were later pulled from the market. This includes Accutane that was on the market for 27 years, Cylert for 30 years and Darvon & Darvocet for 55 years. Now, we have to accept that the tests then were not on a level we have nowadays, yet when we read the effect of serious toxicity to the heart, with a death toll of well over 2100 deaths between 1981 and 1999, there is an issue and as such, the request from Robert De Niro is not that outrageous. In opposition we see that the overall testing is a lot better, and if there is enough support that the half-life of Ethyl mercury is 7-10 days, there should be clear warnings with using it, but if there is enough support for the safety, what is the problem? I see it to some extent in ‘does not accumulate in the body to such an extent‘, to what extent does it accumulate? That is the serious question that needs a clear answer. Are there exceptions? Is there an issue to the parts that do accumulate? Questions that are not available at present (as far as I can tell), so in all this Robert De Niro is asking the right question and it gives concern, because is the AAP consideration we see in ‘removing thimerosal use in preservatives as a precautionary measure‘ also a misrepresentation? Is it a precaution, or was this released in 2013, in the time of the Obama Administration, voiced as such to prevent an anti-vaccine panic from happening?

Is that so far out of bounds? The problem is that for the most the media does not have the knowledge, the many who do have the knowledge tend to work for pharmaceutical companies, or they work for government installations working for politicians who depend on the support of pharmaceuticals. It seems that in no way will the people be more likely than not be properly and correctly informed, that part has been proven for almost two decades.

The only part that worries me is that in the end, it is the $100K payment from Robert De Niro for the media to take an optional serious (opposition) stand. When you google FDA you see very little actual news, when you Google Pharmaceuticals you get loads of news, and 99% linked to awards, pricing, acquisition and profit performance. This is exactly why the people are getting less and less trusting of pharmaceutical companies. It is not merely a marketing thing, it is a distrust that comes from several paths of information.

Here we get to Vexxed, a movie by no one else than the debunked and fraud driven Andrew Wakefield who became writer director of the movie after he was gutted in court. A five-member statutory tribunal of the GMC found three dozen charges proven, this was on 28th January 2010. It includes 4 counts of dishonesty. In addition the panel ruled that Wakefield had “failed in his duties as a responsible consultant” which tends to be a very serious charge. The 1998 publication was, on the findings of the GMC’s, noting that elements of the manuscript had been falsified, fully retracted.

The fear the paper brought by Andrew Wakefield have had consequences, a false paper that led to vaccine mistrust and resulting in serious illness and deaths, which now beckons the question, if this result repeats after the movie, can Andrew Wakefield be arrested and convicted of murder? The paper has issues that there was no intent to endanger lives, but the movie is a repeat of the previous event, intent can be the natural acceptance of a repeated fact. The issue I see is that pharmaceutical companies have actively created waves of mistrust fuelling the existence of conspiracy theories, the movie Vaxxed could be seen as such. I have not seen the movie, so I am keeping an open mind, yet the truth is that I am a child of vaccines in the old age, in this new age, where it is less about health, and more about profit, the voice of conspiracy theorists might have valid views. I say again ‘might’, I wonder how these people look at a movie like Contagion, the masterpiece of Steven Soderbergh who shows in a fictional setting the nightmare that the CDC faces in an ongoing fight to find solutions of some of the most contagious and in some cases still incurable diseases. I reckon that if you feel you want the truth, seeing Vaxxed, whilst never seeing Contagion will never ever get you the truth. Because the fear we see in Contagion was a reality after WW2. Millions in a weakened state and diseases like the measles were running freely all over the world, now we see statistics from 1980 with 851,849 European cases, to 16,899 cases in 2014, a clear decrease due to the vaccine regime of the 50’s and 60’s. Now see a mortality rate of 0.1% – 0.2%, whilst in 1900 the mortality rate in the US was 4% for measles. Smallpox in the periods 1900-1904, had a mortality rate of around 11.5%, we can claim (to some extent) that even though there were mitigating circumstances (like hygiene), vaccinations have been a great success. There is little to no opposing debate on that.

So how is this for the MMR vaccine and thiomersal?

This is the issue that Robert De Niro is raising and in addition to him raising this he is asking very valid questions. It is however equally important that a person like Andrew Wakefield should not be taken at his word. This is not merely him versus the world, when you look at all the information, the competitor he promoted remained silent for all this time as far as I have been able to ascertain, there was no open outrage of this competitor coming with academics showing valid numbers in opposition of the tribunal findings, in addition no evidence that there was a danger, that part has never ever been shown. Did the news dig there, did we get a clear low down from the World Health Organisation (WHO)? Is it that far-fetched that as the Andrew Wakefield scandal caused an increase in morbidity due to lower vaccinations that both the WHO and the CDC would have a clear need to intervene with facts? Are these questions so strange?

In that same part we see the Huffington Post in 2014 giving us, via columnist Lawrence Solomon quotes like “Merck, the pharmaceutical giant, is facing a slew of controversies over its Measles-Mumps-Rubella (MMR) vaccine following numerous allegations of wrongdoing from different parties in the medical field, including two former Merck scientists-turned-whistle-blowers. A third whistle-blower, this one a scientist at the Centers for Disease Control, also promises to bring Merck grief following his confession of misconduct involving the same MMR vaccine“, from that point of view, the moment Vexxed was announced, the CDC should have a clear voice stating the issues (if there are any) regarding the MMR vaccine, in equal measure, if Lawrence Solomon is ‘merely’ a columnist, why this news did not make it to the front pages on a global scale, and if this was not true, why did the Huffington Post run with it? (at http://www.huffingtonpost.ca/lawrence-solomon/merck-whistleblowers_b_5881914.html), it even has links with the court documents, which is even more of a concern.

In conclusion I need to state that if we accept that the Andrew Wakefield disaster came with deaths when the paper was published, the deaths that could be proven to stem from Vexxed require the courts on a global scale to indict Andrew Wakefield with attempted murder for those who get sick and murder for those who die due to non-vaccination. This is not a ‘maybe’ or a ‘freedom of speech’ issue. When it causes the intentional deaths of others it is murder, plain and simple!

As for Robert De Niro, he does make a case to get medical solutions to the people in a safer way, but which way cannot be stated, because it is a track that takes a long time, he has the option to get the support of the media and the medical profession to take another really serious look at thiomersal. I still had questions and next to Robert De Niro, I am the clever one (read: nothing wrong with my ego)!

This gets us to the final part that the Washington Post gave us in May 2016. The quote “create an impression that there was a link by falsifying the data“, which we basically covered earlier, yet to see it this harsh is still important and it changes the taste of the movie by a lot. In here we also see “Actor Robert De Niro, who has an autistic son, originally lobbied to put the film on the schedule for the Tribeca Film Festival in March. But several days later, he said he had a change of heart“, which is another matter, in that that his questions and the fact that he puts up $100K is still valid, perhaps even more valid. It is my interest that gets piqued with “Dozens of top journals — including the New England Journal of Medicine, the Journal of Paediatric Infectious Diseases and the Journal of Autism and Developmental Disorders — have published papers that looked into a possible link and found none“, with the part that the visibility of all this has not been that high, it is my believe that whomever puts the Robert De Niro story out (as it is valid news) should also show all links to these journals, because as it is, Andrew Wakefield gets, due to the global scepticism of pharmaceuticals, a little too much consideration.

So as we gave the smallest consideration for the other side, we must give vision to what is an actual solution for the children of the world, in that the questions of Robert De Niro remain valid, we need to get solution to the people in a safer way and some questions regarding thimerosal remain, perhaps the journalists who are vetting to get a $100K bonus will take another look and answer those questions too. It is not some conspiracy theory thing, it is merely how the AAP decided to voice it, not wrong, just in a way that left us with questions.

 

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