Guidelines Written and Manipulated by Insiders

Professional Societies Should Abstain From Authorship of Guidelines and Disease Definition Statements – John P.A. Ioannidis – Oct 2018

Guidelines and other statements from professional societies have become increasingly influential. These documents shape how disease should be prevented and treated and what should come within the remit of medical care.

Changes in definition of illness can easily increase overnight by millions the number of people who deserve specialist care. This has been seen repeatedly in conditions as diverse as hypertension, diabetes mellitus, composite cardiovascular risk, depression, rheumatoid arthritis, or gastroesophageal reflux.

Similarly, changes in prevention or treatment options may escalate overnight the required cost of care by billions of dollars.

For example, if we accept PROP’s argument that we’re all addicted to our “heroin pills”, we’d all suddenly need “addiction-recovery programs/clinics/residential treatment centers/resorts” for our  “substance abuse” instead of “chronic pain”. 

Indian industry in denial over drug-quality charges

Indian pharmaceutical industry in denial over drug-quality charges – STAT

Katherine Eban’s new book, “Bottle of Lies,” has focused a very intense spotlight on the mostly ignored transgressions of the Indian generic pharmaceutical industry in the processes they follow — or all too often don’t follow — to make quality products.

This industry, which has rarely been subjected to such rigorous journalistic scrutiny, has lashed back at Eban, attacking her integrity and her work.

The latest salvo comes from Kiran Mazumdar Shaw, who calls Eban’s exposé anecdotal, biased, unfair, and unbalanced, and accuses the author of playing up to the poor perceptions of the Indian pharmaceutical industry and the country.  

Pharmaceutical Supply Chain Thefts

Pharmaceutical Supply Chain Thefts – CA State Board of Pharmacy – Virginia Herold, Executive Officer – Aug 2013

This text from a PowerPoint Slide Presentation gives a view into a high impact, but little-discussed, type of drug diversion: from the supply chain where huge amounts of pills are shipped and stored in various warehouses.

Changes in Controlled Substance Loss Profile

2000 – TEN YEARS AGO

• manufacturing losses rare
• wholesale losses rare, usually losses within the wholesale premises
• pharmacy losses – varied and small some self use.

Generic Drugs Are Poisoning Us

A New Book Argues That Generic Drugs Are Poisoning Us – New York Times  – By David Dobbs – May 13, 2019

This is a review of a recently published book exposing the seamy side of the “profit above all else” generic drug industry:

The Inside Story of the Generic Drug Boom
By Katherine Eban

I’ve always been suspicious of generic drugs because I’ve noticed that my body sometimes reacts slightly differently to a new batch, and often reacts very differently to a switch from brand-name medications to generic. This book validates my concerns and even adds new ones. 

Can we trust generic drugs?

Opinion | Americans Need Generic Drugs. But Can They Trust Them? – NY Times – By Katherine Eban May 2019

Technicians used initial hidden tests to get preliminary results, which then guided them as they tinkered with the test settings.

Then they retested in the plant’s official system to get the desired results showing that the drugs fell within specifications. Those drugs with altered test results could then be released to patients.

During his 27 months in India, of the 38 drug plants he inspected, Mr. Baker found fraudulent or deceptive data in 29 of them.   

Rein In ‘Sociopaths’ in the Boardroom

Ex-Corporate Lawyer’s Idea: Rein In ‘Sociopaths’ in the Boardroom – NY Times – By Andrew Ross Sorkin – July 2019

This “reformed” lawyer points out a fundamental flaw of our capitalist system that is responsible for increasing income inequality (rich getting richer, poor getting poorer), dysfunctional government (gridlock), and social decay (deaths of despair).

These troubles stem from a particular aspect of corporate law, and he proposes a relatively simple solution to change how corporations operate.

Jamie Gamble, a retired corporate lawyer, has had an epiphany in recent years: The executives who hired him and that his firm sought to protect, he said, “are legally obligated to act like sociopaths.”  

PLOS ONE pulls highly cited mindfulness paper

PLOS ONE pulls highly cited mindfulness paper over undeclared ties, other concerns – by Adam Marcus – Apr 2019

Mindfulness “peaked” a few years ago and has received much less attention lately, perhaps because it has always been a more hyped than proven do-it-yourself “treatment”.

It appeared to help pain patients, but after the first excitement, enthusiasm, and hope for betterment through this DIY treatment fades, the pain is still there for most of us. I find mindfulness to be appropriate in my daily life, to center myself after having been angered or frightened by what I read, but I’ve never experienced any pain relief from it.

PLoS ONE has retracted a meta-analysis on mindfulness after determining that the authors used dubious methodology and failed to adequately report their financial interest in the psychological treatment the article found effective.

The media are getting the opioid crisis all wrong

The media are getting the opioid crisis all wrong | Washingon Examiner |by Gabe Weissman | Aug 2019

Last week marked yet another ill-conceived media attack on the drug distributors.In an attempt to paint the broader industry as a group of entirely bad actors, the press has yet again taken data out of context and pushed the false narrative that distributors knowingly fueled the opioid epidemic.

In this case, the public release of the Automated Reports and Consolidated Ordering System, or ARCOS, database spanning from 2006 to 2012 demonstrated that distributors document each order of prescription opioids and share that information exclusively with the Drug Enforcement Agency. 

So, the DEA is the only agency that had data for all opioids shipped, yet they stood idly by as bizarrely large orders went to tiny rural pharmacies. I don’t understand why they aren’t being blamed for allowing such massive shipments when they had both the data and the authority to curtail them. 

Opioid Moderation

Opioid moderatism and the imperative of rapprochement in pain medicine – free full-text /PMC6388760/ – byMichael E Schatman, Alexis Vasciannie, and Ronald J Kulich –  J Pain Res. Feb 2019

A brief history of the “prescription opioid crisis”

Although many have attempted to blame this crisis on a single cause, more thoughtful analysis has yielded numerous contributors to the onset and maintenance of the abuse crisis.

health insurance carriers’ decision to discontinue coverage of interdisciplinary pain management programs left physicians without the most effective means of treating chronic pain, resulting in the consequence of turning to increased opioid prescribing.

There are many in the pain community who will not acknowledge this dubious conjecture. I don’t really believe it either but will concede the point if it allows us to initiate a dialog with the “opposition”.  

The Levels of Evidence in Evidence-Based Medicine

The Levels of Evidence and their role in Evidence-Based Medicine – free full-text /PMC3124652/ – Jul 2012

This article explains how different kinds of evidence for different types of studies are graded. It makes even clearer the crime of the CDC to allow a bunch of addiction specialists to issue practice guidelines out of their area of expertise based on low-quality evidence.

Abstract

As the name suggests, evidence-based medicine (EBM), is about finding evidence and using that evidence to make clinical decisions.

A cornerstone of EBM is the hierarchical system of classifying evidence. This hierarchy is known as the levels of evidence.

it is important to understand the history behind the levels and how they should be interpreted. This paper will focus on the origin of levels of evidence, their relevance to the EBM movement.