Open Thread Friday 2-14-2020
The opioid addiction is not a problem originating in the poor. One needs funds to develop a habit. It is a path to poverty that many individuals and their families have traveled.
The opioid overdose and addiction problem is not because people are in despair and communities hopeless. The safety net government and healthcare professionals built up over decades was destroyed for profit. Individuals were unaware of the dangers of the drugs they were prescribed. Healthcare professionals were reeducated, prompted and enforced to provide opioids for pain relief. Then after public outcry became loud enough they were reeducated, prompted and enforced to provide alternatives to opioids for pain relief. Many individuals who now have lifelong physical dependency and new health problems were abruptly denied prescription drugs or at minimum insurance coverage of the medications. Illicit use of opioid products increased with all the associated societal problems.
watch 3:21 to 9:34
New drugs are better, safer and have less side effects than old drugs that have been used for years. Current science should be used to determine treatments and not traditional medical practices for today's modern patient. This argument was used during the Civil War to encourage the use of morphine to replace laudanum (an opium tincture). WWI encouraging the use of heroin to replace morphine. Prior to WWII oxycodone was introduced as a non-addicting pain med alternative for codeine, morphine and heroin.
Antibiotics and Infection control increased the viability of more surgical procedures to treat medical conditions. Opioid pain medications became routinely prescribed after surgery to control pain associated with treatment. HIPPA (healthcare information portability act) of 1996 restricted the interaction of healthcare practitioners to work together to address addiction problems in individuals and communities. Programs developed in local communities across the country had to be abandoned.
The Drug Enforcement Agency created in 1973 to enforce the Controlled Substances Act
of 1970 controls all aspects of controlled (scheduled) drugs. Its regulates volume manufactured and tracks deliveries to wholesalers, pharmacies, healthcare facilities and practitioners. Actual counts are to be maintained on schedule 2 drugs such as morphine, long-acting opioids, amphetamines and cocaine. In the past patient names were private, that privacy has been lost as the opioid epidemic became worse and databases were created for states law enforcement to monitor for potential "problems". Reported this past July the failure of the DEA to do its job to protect Americans.
US District Judge Dan Polster presiding over nationwide opioid litigation dismissed an order that now allows the general public, for the first time ever, to examine opioid sales from the Drug Enforcement Administration's Automation of Reports and Consolidated Orders System (ARCOS) that details how the opioid epidemic exploded into almost every community across the US from 2006 through 2012.
.As per The Washington Post, the ACROS data showed big pharmaceutical companies pumped 76 billion oxycodone and hydrocodone pills from 2006 through 2012 into nearly every zip code across the country.
The harsh truth behind the ARCOS data is that it's not Mexico and China who are responsible for the opioid crisis, as the Trump admin likes to scapegoat frequently, it's the corporate elitists who control big pharma, led to the overdose deaths of so many Americans over the last decade without government doing a damn thing about it.
If you were 43 years old in 2001 your age group accounted for 37% of the opioid overdose deaths, in 2009 at 51 years old 29% and in 2018 at 60 years old 20%. (Interactive table and maps of national and state overdose data.) Changes to allow direct patient advertising of prescription drugs and approval of long acting opioids occurred during Clinton presidency. During Bush presidency 188,664 individual person's death were designated as overdoses, Obama presidency 216,491 deaths, and first 2 years of the Trump presidency 94,402 deaths. From a callous economic outlook every person that dies will not collect their social security or pension.
These new evangelists painted a picture of a nation awash in chronic pain that could be relieved if only the medical profession would overcome its prejudices. They constructed a web of claims they said were rooted in science to back their case, including an assertion that the risk of addiction from narcotic painkillers was “less than 1%” and that dosages could be increased without limit until the pain was overcome. But the evidence was, at best, thin and in time would not stand up to detailed scrutiny. One theory, promoted by Dr David Haddox, was that patients genuinely experiencing pain could not become addicted to opioids because the pain neutralised the euphoria caused by the narcotic. He said that what looked to prescribing doctors like a patient hooked on the drug was “pseudo-addiction”.
Long after the epidemic took hold, and the death toll rose into the hundreds of thousands in the US, Portenoy admitted that there was little basis for this claim and that he had been more interested in changing attitudes to opioids among doctors than in scientific rigour.
“In essence, this was education to destigmatise and because the primary goal was to destigmatise, we often left evidence behind,” he admitted years later as the scale of the epidemic unfolded.
Likewise, Haddox’s theory of pseudo-addiction was based on the study of a single cancer patient.
As the influence of the opioid evangelists grew, and restraints on prescribing loosened, the pharmaceutical industry moved to the fore with a push to make opioids the default treatment for pain, and to take advantage of the huge profits to be made from mass prescribing of a drug that was cheap to produce.
The American Pain Society, a body partially funded by pharmaceutical companies, was pushing the concept of pain as the “fifth vital sign”, alongside other measures of health such as heart rate and blood pressure. “Vital signs are taken seriously,” said its president, James Campbell, in a 1996 speech to the society. “If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. We need to train doctors and nurses to treat pain as a vital sign.”
The APS wanted the practice of checking pain as a vital sign as a matter of routine adopted in American hospitals. The key was to win over the Joint Commission for Accreditation of Healthcare Organizations, which certifies about 20,000 hospitals and clinics in the US. Its stamp of approval is the gateway for medical facilities to tap into the huge pot of federal money paying for healthcare for older, disabled and poor people. Hospitals are careful not to get on the wrong side of the joint commission’s “best practices” or to fail its regular performance reviews.
In response to what it called “the national outcry about the widespread problem of under-treatment” – an outcry in good part generated by drug manufacturers – the commission issued new standards for pain care in 2001. Hospital administrators picked over the document to ensure they understood exactly what was required.
Lucas and Ledgerwood had their own study on the impact of opioids in the works. They came to believe the tyranny of the colour-coded smiley faces was costing lives. Years of surgery have given Lucas a healthy respect for pain as a tool for recovery. To suppress it was dangerous. But as large doses of opioids became the norm, the surgeon noted an increasing number of incidents of patients struggling to breathe after routine operations and being moved to intensive care.
Lucas and Ledgerwood visited trauma centres to collect data on deaths before and after the joint commission standards on pain treatment. In 2007, the two doctors published their findings. Before the commission’s dictum, 0.7% of trauma centre patients died from “excess administration of pain medicines”. The death toll rose to 3.6% after the commission’s policies kicked in.
“In each case, administration of sedation led to a change in vital signs or a deterioration in the respiratory status requiring some type of intervention which, in turn, led to a cascade of events resulting in death,” the paper said. Those were only the deaths in which there was little doubt opioids were responsible, and the real toll was almost certainly higher. “Overmedication with sedatives/narcotics … clearly contributed to deaths,” the study concluded.
The movement to electronic medical records created an opportunity to further influence prescribers. It depends where a business and individual is in the chain of influencing drug choices as to whether it is legal to accept compensation or encouragement from a pharmaceutical company to increase the use of their products. Decision making software companies should not accept payments.
Doctors relied on Practice Fusion's system to make decisions about which drugs to prescribe. This relationship wasn't just immoral, it was blatantly illegal, prosecutors said, having violated anti-kickback statutes.
"Across the country, physicians rely on electronic health records software to provide vital patient data and unbiased medical information during critical encounters with patients," said Principal Deputy Assistant Attorney General Ethan Davis of the Department of Justice’s Civil Division. "Kickbacks from drug companies to software vendors that are designed to improperly influence the physician-patient relationship are unacceptable. When a software vendor claims to be providing unbiased medical information – especially information relating to the prescription of opioids – we expect honesty and candor to the physicians making treatment decisions based on that information."
Specifically, in exchange for a “sponsorship” payment from a pharmaceutical company of nearly $1 million, Practice Fusion allowed the companies to influence the development and implementation of what are called CDS alerts in its EHR software. These "pain" alerts would prompt doctors to prescribe more opioids, the software company said, advising opioid makers that it would help boost their sales.
In exchange for the payment, Practice Fusion allowed opioid makers to include their "input" in the development of the company's CDS alerts. In an extra-cruel twist, payments were financed by the unnamed opioid maker's marketing department.
Judicial system continues to let us down.
In a 2004 ruling, Judge Stephens rejected Purdue’s motion that he dismiss the case and sided with the state’s assertion that the material could convince a jury that Purdue’s sales pitch was full of dangerous lies.
But Stephens sealed the evidence on which he relied in that ruling. And when Purdue and the state reached a settlement that year, before the case went to trial, the evidence remained hidden, out of sight to regulators, doctors and patients.
It would be 12 years – and 245,000 overdose deaths – before evidence Stephens and other judges kept hidden was made public, and then only after it was leaked to a newspaper. What it showed was revelatory: OxyContin, the first billion-dollar-a-year narcotic, was not the reliable 12-hour painkiller Purdue long claimed it was. Its effects often wore off much sooner, exposing patients to a relapse of pain, withdrawal, or both – suffering relieved only by the next pill. When doctors raised concerns, the documents showed, Purdue sales reps counseled them to put patients on bigger, more dangerous doses.
The eventual release of the evidence reinforced the widely held view that OxyContin was a catalyst for the epidemic, which by then had expanded beyond prescription opioids to include illicit drugs such as heroin. The material also informed hundreds of new lawsuits seeking to force accountability on the entire opioid industry for its role in the addiction crisis.
Federal Judge Dan Polster has maintained a consistent secrecy in the nearly 2,000 lawsuits against the opioid industry consolidated in his Cleveland court, allowing evidence drawn from millions of records on industry practices to be filed under seal. Northern District of Ohio/Handout via REUTERS
But for untold numbers of opioid users who had overdosed, it was too late.
Today, 15 years after Stephens protected Purdue’s secrets, Federal Judge Dan Polster is providing the same cover for multiple opioid makers, distributors and retailers. He is presiding over a mass of litigation that seeks to hold the entire industry responsible for the epidemic. Life-saving information contained in those cases, too, may remain under seal, as Polster has stuck to a strict secrecy playbook.
SECRECY IS NOT LIMITED TO OPIOIDS
The trail of hidden evidence running through the opioid crisis is emblematic of a pervasive and deadly secrecy that shrouds product-liability cases in U.S. courts, enabled by judges who routinely allow the makers of those products to keep information pertinent to public health and safety under wraps. And since nearly all such cases are resolved before trial, the evidence often remains secret indefinitely, robbing consumers of the chance to make informed choices and regulators of opportunities to improve safety.
Food and Drug Administration tasked with the responsibility to protect consumer and public health has become an enabler of poor industry practices.
A newly released report says the Food and Drug Administration may have failed to set strict enough standards and follow-through for training doctors about the risks associated with opioids. Researchers say lack of oversight and training problems happened while the opioid crisis killed tens of thousands of people a year.
The rules were part of what's called a Risk Evaluation and Mitigation Strategy, or REMS, which required manufacturers of long-acting and addictive opioids like OxyContin to pay for training for doctors prescribing the drugs, and to monitor and report back on how well that training was working. But in the study published in JAMA Internal Medicine, researchers at Johns Hopkins University found that didn't happen.
The report said long-acting or "extended-release" opioids such as oxycodone and morphine "were associated with greater risk of addiction, unintentional overdose and death than their immediate-release counterparts."
So in 2012, the FDA set up rules requiring painkiller manufacturers to deliver "continuing education" to doctors and "develop medication guides to inform patients about risks" as well as monitor and report on "patient access to drugs and safety."
But problem was that the FDA let the pharmaceutical companies themselves create the curriculum, experts say.
After this story ran on "CBS This Morning," an FDA spokesperson reached out to dispute Kolodny. She wrote that "the REMS program was an educational component, limited by lack of a mandatory federal requirement that prescribers take the training." The spokesperson also said "there is no evidence that at any point (the program) contributed to the crisis."
When I advocate taking responsibility for your own health and those close to you it is not from the point of personal responsibility. It is more from a safety issue. Parts of America's medical care is miraculous for the treatments provided. There are many more parts that are disjointed and the goal is not to fix an individual's healthcare problems. Individual practitioners have to work within the system, may not be aware safety nets have disappeared or may be simply overwhelmed themselves.
Continuing the Journey into Chinese Medicine
In older Chinese texts pain is a symptom used to diagnose, monitor effectiveness of treatment and changes in condition. Pain relief alone was not a goal of treatment, it was byproduct of healing an underlying imbalance or condition.
Opium poppy began appearing in Chinese writing is association with Buddhist temples. The seed grown as a food and later the plant was used specifically as a medical treatment.
From these early descriptions of the opium poppy in Chinese sources, the one which appeared in Bencao Tujing by Su Song would be the most influential: 33
About opium poppy, the classics do not tell where it originates from, but nowadays it is found everywhere, as many families use it to decorate their gardens. It can be red or white and has a pungent smell. Its fruit looks like a bottle or an arrowhead, and stores tiny seeds inside. They are hard to cultivate. They must be planted during the ninth month, in a piece of land which was manured the year before. If not cultivated in this way, it will never germinate. One should wait until the fruits acquire a yellow colour before picking them. It is prescribed for improving the circulation of qi and reducing fever. It cures nausea, phlegm in the chest and cinnabar poisoning. It is said that it can be cooked with bamboo juice to make porridge. It is a cold medicine and very good for the intestines. However, it is not advisable to consume it excessively, as it can alter the qi in the bladder. 34