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Opioids, the Quiet Killer

(Dan here…re posted from March 7, Angry Bear)

by run 75441

There are no loud guns shots in the middle of the night. No screams for help or sounds of cars speeding away. No police sirens or flashing lights. It is pretty quiet when someone ODs on Opioids unless someone finds them before it is too late.

As I wrote earlier; “From 2006 to 2015, pharmaceutical companies spent opioids-policies">$880 million in lobbyingstate and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Opioid manufacturer lobbying expenditures has outstripped those such as STOPPNow advocating for greater controls on Opioids and prescriptions by 200 times at the state level.”

In comparison, only the NRA and its gun lobbying efforts in legislatures displays a similar capability to oppose and defeat any and all laws for bullet-spewing-weapons laws the same as the Opioid industry efforts to block legislation. Legislators pay attention when either industry or lobby calls on them.

Any particular article advocating greater regulation of Opioids or reporting of Opioid dangers on medical blogs such as Medscape, centers such as opioids-policies">Public Integrity, news agencies such as Associated Press are met with a resistance (if they still have a comments section) the same as what is found on sites when they advocate for greater “gun control.” The evidence is overwhelming that there is an opioid epidemic in the nation resulting from usage and is similar to the epidemic of injury and deaths resulting from guns. Quietly, the industry and their lobbyists work the legislatures to stymie any effort to control opioids.

Latest Findings by the CDC

Today, opioids/71580?xid=nl_mpt_DHE_2018-03-07&eun=g1190552d0r&pos=0&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-03-07&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days">Medscape reported:

Emergency department (ED) visits for suspected opioid overdoses rose by 30% throughout the U.S. in a year, according to the CDC.

“All five regions of the U.S. saw significant increases during this time period,” said Anne Schuchat, MD, acting CDC director, in a CDC tele-briefing Tuesday.

If you come back later to Medscape article, you will see the comments section flooded with what appears to be an organized opposition to what supported facts MedScape presents and consequently any and all suggested Opioid control. Many of the posters appear to be the same ones time and time again. It is pretty apparent the pharma industry is attuned to any medical backed article going up advocating for Opioid control.

The analysis backing the increase in Opioid ER visits can be found in a new CDC Vital Signs report. The basis of its findings are from ~91 million ED visits in 52 jurisdictions in 45 states from July 2016 to September 2017. The data is reported in the CDC’s National Syndromic Surveillance Program (NSSP) Biosense Platform. The 142,557 visits to the ER reported as suspected opioid overdose cases equate to a 29.7% increase from the previous 1-year period.

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Opioids, the Quiet Killer

There are no loud guns shots in the middle of the night. No screams for help or sounds of cars speeding away. No police sirens or flashing lights. It is pretty quiet when someone ODs on Opioids unless someone finds them before it is too late.

As I wrote earlier; “From 2006 to 2015, pharmaceutical companies spent opioids-policies">$880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Opioid manufacturer lobbying expenditures has outstripped those such as STOPPNow advocating for greater controls on Opioids and prescriptions by 200 times at the state level.”

In comparison, only the NRA and its gun lobbying efforts in legislatures displays a similar capability to oppose and defeat any and all laws for bullet-spewing-weapons laws the same as the Opioid industry efforts to block legislation. Legislators pay attention when either industry or lobby calls on them.

Any particular article advocating greater regulation of Opioids or reporting of Opioid dangers on medical blogs such as Medscape, centers such as opioids-policies" >Public Integrity, news agencies such as Associated Press are met with a resistance (if they still have a comments section) the same as what is found on sites when they advocate for greater “gun control.” The evidence is overwhelming that there is an opioid epidemic in the nation resulting from usage and is similar to the epidemic of injury and deaths resulting from guns. Quietly, the industry and their lobbyists work the legislatures to stymie any effort to control opioids.

Latest Findings by the CDC

Today, opioids/71580?xid=nl_mpt_DHE_2018-03-07&eun=g1190552d0r&pos=0&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-03-07&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days" >Medscape reported:

Emergency department (ED) visits for suspected opioid overdoses rose by 30% throughout the U.S. in a year, according to the CDC.

“All five regions of the U.S. saw significant increases during this time period,” said Anne Schuchat, MD, acting CDC director, in a CDC tele-briefing Tuesday.

If you come back later to Medscape article, you will see the comments section flooded with what appears to be an organized opposition to what supported facts MedScape presents and consequently any and all suggested Opioid control. Many of the posters appear to be the same ones time and time again. It is pretty apparent the pharma industry is attuned to any medical backed article going up advocating for Opioid control.

The analysis backing the increase in Opioid ER visits can be found in a new CDC Vital Signs report. The basis of its findings are from ~91 million ED visits in 52 jurisdictions in 45 states from July 2016 to September 2017. The data is reported in the CDC’s National Syndromic Surveillance Program (NSSP) Biosense Platform. The 142,557 visits to the ER reported as suspected opioid overdose cases equate to a 29.7% increase from the previous 1-year period.

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Crack v. Opioids and Violence v. Racism

Here’s is a PBS commentary by law professor Ekow Yankah:

That Kroger, the Midwestern grocery chain, has decided to make the heroin overdose drug naloxone available without a prescription is a sign of how ominous the current epidemic has grown.
Faced with a rising wave of addiction, misery, crime and death, our nation has linked arms to save souls. Senators and CEOs, Midwestern pharmacies and even tough-on-crime Republican presidential candidates now speak with moving compassion about the real people crippled by addiction.

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The AMA is Calling for a Relaxing of CMC Opioid Prescription Restrictions

A little history:

In 1980, the Porter and Jick letter to the editor of the New England Journal of Medicine by the Boston Collaborative Drug Surveillance Program stated:

“the risk of addiction was low when opioids such as oxycodone were prescribed for chronic pain.”

It was a brief statement by the doctors conducting the study, taken out of context, and cited many times afterwards as justification for the use of oxycodone.

In a June 1, 2017 letter to the NEJM editor, the authors reported on the broad and undocumented assumptions made as a result of the 1980 Letter on the Risk of Opioid Addiction.. Using bibliometric analysis of the impact of this letter to the editor, the citations of the 1980 letter were reviewed to determine the citation’s portrayal of the letter’s conclusions.

Identified in the bar chart are the number (608) of citations of the 1980 letter over a period of time from 1981 to 2017.

“72.2% (439) of the citations, quoted the letter or used it as evidence addiction was rare in patients when treated with opioids such as oxycodone. 80.8% or 491 of the citations failed to note the patients described in the letter were hospitalized at the time they received the prescription.”

There was a sizable increase of citations after the introduction of OxyContin (extended release oxycodone) in 1995. As the analysis noted “affirmational citations of the letter have become less common in recent years in contrast to the 439 (72.2%) positive and supporting citations of the 1980 correspondence in earlier years. The frequency of citation of this 1980 letter stands out as being unusual when compared to other published and cited letters. Eleven other published, stand-alone, and more recent letters on different topics published by the NEJM were cited at a median statistic of 11 times each.

Citations of the 1980 standalone letter on “addiction being rare” from the use of opioids such as oxycodone failed to mention, the patients administered to were in a hospital setting as noted in the Porter and Jick letter. Overlooked, a mistake, intentional misquote by the people citing this letter?

In 2007 in the pharmaceutical industry, “the manufacturer of OxyContin and three senior executives of Purdue Pharma plead guilty to federal criminal charges that they misled regulators, doctors, and patients about the risk of addiction associated with OxyContin.”

This year, law makers questioned Miami-Luken and H.D. Smith wanting to know why millions of hydrocodone and oxycodone pills were sent (2006 to 2016) to five pharmacies in four tiny West Virginia towns having a total population of about 22,000. Ten million pills were shipped to two small pharmacies in Williamson, West Virginia. The number of deaths increased along with the company and wholesaler profits.

60% of all drug-poisoning deaths in 2013 involved prescription opioids and/or heroin. Among individuals aged 25 to 64 years, deaths from a drug overdose—the majority of which were opioid-related—exceeded motor vehicle collisions as the leading cause of accidental death in 2013. Four in five new heroin users started out misusing prescription painkillers.

The information is out there as to why the abuse of opioids and related drugs is increasing. It is being ignored or argued against as limiting a patients rights to have unhindered access to opioids by doctors and patients alike. Sound familiar, similar to the gun lobby?

Today

AMA Delegates Back Physician Freedom in Opioid Prescribing At best, 20% of all doctors are members and the percentage has been declining. From the meeting; “The CDC’s guidelines on the use of opioids for pain management are well-intentioned, but some insurers and pharmacists have used them to restrict providing and need to be discouraged from doing so, members of the American Medical Association (AMA) House of Delegates said Tuesday.”

And the CDC response as told by one doctor. “a member of a pain management task force being convened by the Department of Health and Human Services. “Draft comments will be coming out in a couple of weeks and will very specifically address the misinterpretation of the CDC guidelines,” he noted. “This is really timely because the comments from the AMA will be extremely important in weighing in [on the issue].”

Doctors do no want interference with decision- making when it comes to patients. At the same time, little has been done to rein in addiction due to prescription opioids which lead to other addictions because prescriptions are expensive or are limited in access. Here is Janet from stopnow blog and who writes about addicted babies due to mothers taking opioids:

More overdose deaths last year than the entire Viet Nam War. The FDA approves sufentanyl 10 times stronger than fentanyl. Yesterday the AMA President was quoted using the same verbiage as Big PhRMA- undertreatment of pain. And now a campaign to undo the CDC guidelines which until they were released doctor education was coming from the drug companies. We need full disclosure – is this funded by Big PhRMA.

Here is a counter argument from a pharmacist where he misapplies the stats to suit his argument:

“it depends what numbers of overdose deaths you are referring to because it is certainly not more deaths due to opioid pain medications. There were 72,000 overdose deaths which includes ALL overdoses from ALL classes of medications. Overdoses from opioids were 49,000 and within that group only 19,354 were from opioid pain relievers. Deaths from fentanyl (illicit) totaled over 29,000, heroin almost 16,000, and cocaine 14,500. (One death could be counted in more than one category, numbers from NIH.) Vietnam war deaths totaled 58,220 versus 19,354 deaths from opioid pain medications. By the way, there were 10,684 deaths due to benzodiazepines, should the CDC mandate doses and days of therapy for those also?

I have no connections with or any payments/gifts from any drug manufacturer. My only concern is that in the national noise of the ‘opioid epidemic’ the focus is on those who abuse opioids and I want to make sure that we still hear the cry of the patient who needs pain relief and who does NOT abuse the medications.”

Yes the pharmacist is correct when he says of the 72,000 deaths only 19,354 can be attributed to opioid pain relievers in 2018. Janet cited the 20 years of Vietnam deaths. The pharmacist conveniently sidesteps the time periods involved here. In three years and if the numbers stay the same (they have been increasing YOY), the numbers of opioid deaths will be slightly less than 20 years of Vietnam if it were to remain at 19,000/year. Four in five new heroin users started out misusing prescription painkillers. Of recently cited 150,000 accidental deaths, opioids">72,000 (a record high) can be attributed to drug overdose deaths, a record high.

And this is ok?

60% of opioid deaths occur in those who were given a prescription by a physician. The other 40% of deaths are caused by people who obtained opioids by “doctor shopping,” and receive multiple scripts at once. The perceived safety and easy accessibility of these drugs have presented the highest risk for most users, even if they eventually seek out illicit opioids or “street drugs.” In 2014, only 22.1% of non-medical users obtained opioids through a doctor, meaning that the diversion rate of these drugs is very concerning. Many people are getting these medications illegally or without doctor supervision.”

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Fighting Opioid and Painkiller Addiction

Some History

In 1980, a letter to the editor of the New England Journal of Medicine by the Boston Collaborative Drug Surveillance Program stated “the risk of addiction was low when opioids such as oxycodone were prescribed for chronic pain.” It was a brief statement by the doctors conducting the study which was cited many times afterwards as justification for the use of oxycodone.

In a June 1, 2017 letter to the NEJM editor, the authors reported on the broad and undocumented assumptions made as a result of the 1980 Letter on the Risk of Opioid Addiction. Using bibliometric analysis of the impact of this letter to the editor, the citations of the 1980 letter were reviewed to determine the citation’s portrayal of the letter’s conclusions.

Identified in the bar chart are the number (608) of citations of the 1980 letter over a period of time from 1981 to 2017.

72.2% (439) of the citations, quoted the letter or used it as evidence addiction was rare in patients when treated with opioids such as oxycodone. 80.8% or 491 of the citations failed to note the patients described in the letter were hospitalized at the time they received the prescription.”

There was a sizable increase of citations after the introduction of OxyContin (extended release oxycodone) in 1995. As the analysis noted “affirmational citations of the letter have become less common in recent years in contrast to the 439 (72.2%) positive and supporting citations of the 1980 correspondence in earlier years. The frequency of citation of this 1980 letter stands out as being unusual when compared to other published and cited letters. Eleven other published, stand-alone, and more recent letters on different topics published by the NEJM were cited at a median statistic of 11 times each.

Citations of the 1980 stand alone letter on “addiction being rare” from the use of opioids such as oxycodone failed to mention, the patients administered to were in a hospital setting as noted in the letter by Porter and Jick. Overlooked, a mistake by the people citing this letter? “In 2007, the manufacturer of OxyContin and three senior executives of Purdue Pharma plead guilty to federal criminal charges that they misled regulators, doctors, and patients about the risk of addiction associated with OxyContin.”

Organization: “An early manifestation of the opioid abuse, addiction, and overdose problem occurred largely in the rural regions of Kentucky and other parts of Appalachia after the introduction of Oxycontin. A brand name for oxycodone, OxyContin was introduced in 1996 by Purdue Pharma and aggressively sold to doctors. Sold as a less-addictive alternative to other painkillers as it was made in a time-release formulation, allowing for a slow onset of the drug, and not a hit all at once which is more likely to lead to abuse. When used as prescribed, Oxycontin was safe. When ground up, it’s slow release characteristics were marginalized.

The aggressive sales pitch led to a spike in prescriptions for OxyContin of which many were for things not requiring a strong painkiller. In 1998, an OxyContin marketing video called “opioids-pain/20180314/opioids-pain">I Got My Life Back,” targeted doctors. In the promotional, a doctor explains opioid painkillers such as OxyContin as being the best pain medicine available, have few if any side effects, and less than 1% of people using them become addicted.

Shortly after 1996, Porter and Jick’s letter citations doubled and continued to be cited in a positive fashion with few negative citations and a failure to mention the hospital setting where the drugs were administered.

More Recent

By 2015 over a six-year period, more than 183,000 deaths from prescription opioids were reported in the United States. Today, millions of Americans are now addicted to opioids.” In part much of this was the result of doctors being told there was a low risk to opioid addiction.

Figure 2 shows each year being progressively worse and reaching a record high of 71,568 deaths (2017) in the US due to all drug overdoses as reported by the Centers for Disease Control (CDC) in their “Provisional* estimates on U.S. drug overdose. According to the CDC this is a record and represents a 6.6% national increase in overdose deaths over 2016.

At the end of the 12-month period of January 2018, the reported deaths was 69,703. The final and predicted number of deaths is expected to be as high as 71,568. 0.18 of 1% of the reports are pending the completion of investigation (numeric within chart). *Underreported due to incomplete data.

*Provisional counts of all drug overdose deaths are underestimated relative to final counts. The degree of underestimation is determined primarily by the percentage of records with the manner of death reported as “pending investigation” and tends to vary by reporting jurisdiction, year, and month of death. Specifically, the number of drug overdose deaths will be underestimated to a larger extent in jurisdictions with higher percentages of records reported as “pending investigation,” and this percentage tends to be higher in more recent months”.

In 2018 law makers questioned Miami-Luken and H.D. Smith wanting to know why millions of hydrocodone and oxycodone pills were sent (2006 to 2016) to five pharmacies in four tiny West Virginia towns having a total population of about 22,000. Ten million pills were shipped to two small pharmacies in Williamson, West Virginia. The number of deaths increased along with the company and wholesaler profits.

For context, the nearly 72,000 drug overdose deaths (spurred by the ongoing opioid painkiller addiction epidemic, including the increased use of more potent synthetic opioids [fentanyl]) outpaced fatalities from suicide, or from influenza and pneumonia, which claimed about 44,000 and 57,000 lives in 2016. It nearly rivaled the approximately 79,500 people who die from diabetes-related complications each year in the U.S. (the 7th leading cause of death).

Nearly 150,000 Americans die each year from accidents such as car crashes, injuries, or accidental overdoses. If the CDC’s latest figures are accurate, drug overdoses could account for nearly half of accidental deaths.

As tends to happen with public health epidemics, overdoses have an outsize effect in certain regions. For instance, the biggest spike in fatalities by percentage occurred in Nebraska, North Carolina, New Jersey, Indiana, and West Virginia (33.3%, 22.5%, 21.1%, 15.1%, and 11.2% rises, respectively). But areas like Wyoming, Utah, and Oklahoma experienced declines of 9.2% to 33%.

With the clamp down on opioid prescriptions by doctors due to the abuse, addiction, and overdoses, those addicted to opioids turned elsewhere. Again Recall Report;

“In 2015 heroin overdose deaths in the U.S. surpassed the number of deaths by gun homicide for the first time ever. In addiction treatment facilities around the country, heroin addiction is becoming the most common reason to enter treatment, surpassing even alcohol addiction.

In combatting the prescription painkiller addiction epidemic, public officials may have unwittingly contributed to the heroin epidemic. As prescription opioids became more difficult to obtain and more expensive, addicts turned to a cheaper similar high: “heroin.” Mexican drug cartels were more than willing to supply the demand and much of the cheap heroin in use in the country now comes through Mexico.”

The ease of accidentally overdosing can be a tragic consequence resulting from the abuse of opioids and heroin. Both drugs act upon areas of the brain controlling breathing and depress it. Too much opioid drug can cause a person to stop breathing and their subsequent death. Add alcohol or a sedative and the risk increases. To combat the impact of overdosing on opioids or heroin, Narcon in an injection or a nasal spray format acts as an antagonist reversing the effects of opioids and the overdose.

Stopping the abuse of opioids is an important measure in gaining control of the growing number of people becoming addicted to opioids and dying from its abuse. Once addicted, treatment is essential with detox and withdrawal the first painful step back to a normal life. Without supervised treatment and/or residing in a residential treatment center, the return to opioid usage and addiction is easy as the cravings for using it again are powerful. As a resident in a treatment center, therapy, support, and medical treatment with drugs is possible.

The abuse of opioids and subsequent addiction will remain a problem for years to come until the supply of it is brought under control.

Prescription Painkiller Addiction: A Gateway to Heroin Addiction, Recall Report Organization

A 1980 Letter on the Risk of Opioid Addiction, NEJM, June 1, 2017

Supplementary Appendix NEJM, June 1, 2017; Copy of Porter and Jick’s letter to NEJM in 1980.

Provisional Drug Overdose Death Counts CDC, National Center for Health Statistics, August 5, 2018

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News on Purdue Pharma…

(Dan here…From Esquire comes this note from the Boston Globe):

We begin with good news up here in the Commonwealth (God save it!), where Attorney General Maura Healey, who does not punch down, has opened hostilities against the pharmaceutical companies that have raked in the profits from the opioid crisis. From The Boston Globe:

She asserts that the privately held company and 16 of its key directors and executives actively obfuscated the truth about opioid use, downplaying the perils of addiction and overdoses with the aim of getting more people to take them at higher doses for longer periods of time in order to boost the business’s bottom line. “Purdue Pharma created the epidemic and profited from it through a web of illegal deceit,” the lawsuit alleges. While several other state attorneys general have taken similar legal action against Purdue, Healey’s action Tuesday opens a new front in the battle against the scourge of overdoses in Massachusetts. And the suit, filed in Suffolk Superior Court, hints the state could be seeking damages to the tune of billions of dollars.

“We found that Purdue misled doctors, patients, and the public about the real risks of their dangerous opioids, including OxyContin,” Healey said at a news conference, standing next to officials including Governor Charlie Baker as well as families who have lost loved ones to overdoses. “Their strategy was simple: The more drugs they sold, the more money they made — and the more people died,” Healey said. An investigation by Healey’s office found that since 2009, 671 people who filled prescriptions for Purdue opioids in Massachusetts subsequently died of an opioid-related overdose, the legal complaint says.

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1000% increase in Drug Addicted Babies in Florida – 2016

Janet Colbert of Stop The Organized Pill Pushers Blog:

“The death rate from Opioids continues to escalate year over year due to Florida ignoring the opiate epidemic for so long. Since STOPPNow (Stop The Organized Pill Pushers) started posting, the death rate went from 7/day in Florida. to 14/day. To keep the pressure on the legislature, I (Janet Colbert) will keep the Stoppnow.com site updated when we have bills that will need support to become law.”

Janet Colbert is a Neonatal Nurse in a Florida hospital caring for newborns who are addicted to opioids at birth.

Sun Sentinel; Gov. Rick Scott has called for $50 million and new legislation to fight the opioid abuse epidemic that has killed hundreds and overwhelmed morgues in South Florida.”

Click on the picture to enlarge it.

If you recall my way-to-long post: How Pharma Influences . . .

The first line of the post:

From 2006 to 2015, pharmaceutical companies spent opioids-policies">$880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Their lobbying expenditures has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

Pharmaceutical companies spend almost twice as much every year as compared to what Florida will spend to fight the Opioid epidemic in Florida over a period of time.

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Big Pharma Influence in State, Federal Government, and Everyday Life

How Pharma Influences Legislation They Do Not Like

From 2006 to 2015, pharmaceutical companies spent opioids-policies">$880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Their lobbying expenditures has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

In 2015, 227 million prescriptions were written for opioids such as OxyContin, Vicodin, and Fentanyl. This was enough prescriptions to give nine of ten adults a bottle of pills. With its aggressive lobbying, the pharmaceutical industry maintains the “status quo of aggressive prescribing of opioids and reaping enormous profits” according to Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing.

Opioids are used to interact with the receptors (protein molecule that receive chemical signals from outside a cell causing a cellular/tissue response) in the body. opioids/">They work with sites in the brain and nervous system known as opioid receptors to stop pain messages from reaching the brain effectively telling you to not feel pain. Opioids are used to counter pain from injuries, surgery, and chronic pain.

While campaigning for a law limiting the initial prescription quantity of an Opioid, Jennifer Weiss-Burke came to realize the strength of the pharmaceutical lobby in New Mexico. Her son Cameron was sent home with a bottle of Percocet to combat and dull the pain from a broken collar bone. A few years later, Cameron died of a heroin over dose.

Jennifer Weiss-Burke had lobbied the New Mexico legislature to limit “initial” pain-killing opioid prescriptions to seven days outside of the needs of chronic pain patients. The bill died in the New Mexico legislature. There was no open discussion of its merits, suggested improvements, proposed compromises, or discussed safeguards to protect those using Opioids for chronic pain. Instead, the Pharmaceutical Lobbyists privately called on each legislator to discuss why they should oppose the bill Weiss-Burke was advocating.

One of the manifestations of substance abuse in New Mexico was prescription drug overdose death. It was not a significant problem ten years before; but, it was developing and unidentified as a significant problem. In 2011, Cameron Weiss Burke died of a heroin overdose. Between 1992 and 2013, New Mexico was at or near the top for drug overdose deaths nationwide. In 2013, New Mexico had a drug overdose death rate of ~ 22 per 100,000 ranking third nationally behind West Virginia and Kentucky (CDC). Yet, the New Mexico legislature chose not to react to this plague and take action?

The pharmaceutical industry is profitable and wields influence across both sides of the aisle in
Congress and at the state level. In the past its lobbying efforts paid off with Congress blocking Medicare, Part D, and the ACA from negotiating directly with Pharma on pricing. Just how strong and profitable is pharmaceuticals? As Dr. Perry Wilson explains; “Different chronic diseases have different patterns of price increases. The biggest increase was seen in diabetes care (1993 – 2013) and driven largely by the rising prices of pharmaceuticals” of which the cost of manufacturing did not increase. Now Secretary of HHS, Alex Azar as the CEO of Eli Lilly raised the price of the century old drug Humalog used to treat diabetes by 345% taking it from $2,657.88 per year to $9,172.80 per year.

With greater profitability comes the ability to employ lobbyists who can call on state and congressional legislators. The opioids-policies"> Opioid industry, associated companies, and their allies have contributed to many candidates at state-level offices and employ an army of lobbyists covering the 50 state legislatures. From 2006 to 2015, the Pain Care Forum, a loose coalition of drugmakers, trade groups and dozens of nonprofits supported by industry funding, spent $740 million to stop laws governing the prescription of opioids. Up from 2016, the pharmaceutical and health products industry spent a record $78 million in 2016.

Because of their lobbying strength in Congress and states, laws and regulations are skewed to benefit the pharmaceutical industry. Medicare, Part D, and the ACA are blocked from negotiating directly with Pharma while insurance companies are too small to take on Pharma and often resort to using Medicare pricing plus a markup. With the appointment of nominee for HHS secretary Alex Azar, the environment for lower pharmaceutical costs by allowing Part D, Medicare, and the ACA to negotiate directly looks dim.

What If They Like a Piece of Legislation?

The pharmaceutical industry can block state legislation by lobbying. If they like a piece of legislation, they can also lobby for it. Fifty-eight pharmaceutical and 26 biotech companies spent $192 million to push the 21st Century Cures Act bill through Congress in 2016. The bill potentially saves drug and device companies $billions in bringing products to market. The Food and Drug Administration will have new authority and tools to speed up approvals and shortcut the process.

– Medical schools, hospitals, and doctors will see increased research dollars coming from a $4.8 billion windfall to the NIH biomedical research organization subject to annual appropriations. “60 schools, 36 hospitals, and several dozen groups representing physician organizations” spent $120 million in lobbying efforts.

– Over two years, $1 billion in state grants will be spent to address Opioid abuse and addiction most of it going to treatment. Mental health and Research got a boost with $millions for old and new programs. Mental health, psychology, and psychiatry groups spent $1.8 million in lobbying disclosures including the 21st Century Cures bill.

– Specialty disease and patient advocacy groups supported the legislation and lobbied Congress. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process. The passage of the bill shows off the clout of such groups in their spending of $6.4 million in lobbying.

– More than a dozen computer, software and telecom companies also kicked in for Cures Act lobbying totaling $35 Million in lobbying on the Cures Act as well as other legislation. It will benefit hospitals and groups requiring new technology and programs.

– Funding for the giveaways? The ACA lost $3.5 billion or 30% of its funding taken from its Prevention and Public Health Fund established to promote the prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.

The bill does nothing to address the rising cost of pharmaceuticals. It promotes unproven and unsafe drug and device approvals which groups such as Public Citizen, Consumer Safety Org., The Associated Press, The Center for Public Integrity, and the National Center for Health Research fought against. The bill leaves the FDA under funded with a miserly boost of $500 million through 2026 to take care of the additional priorities imposed upon the FDA.

And The Politics?

Michigan Representative Fred Upton’s sponsored 21st Century Cures which will save drug and device companies $billions in bringing products to market by short circuiting FDA testing. The Food and Drug Administration will have new authority and tools to bypass studies and speed up approvals. Translated what this means is; the bill allows the FDA to approve new uses, or indications, for existing drugs without rigorous clinical trials and tests now being conducted following proven practices. This would include not taking randomized samples to prove the new drugs are safe and effective. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. According to Public Citizen’s Michael Carome this a much lower level of evidenced and proven usage.

No friend to the ACA, Michigan Representative Fred Upton sabotaged the ACA Rick Corridor Program and continues to weaken it by taking $3.5 billion or 30 percent of the funding from the Prevention and Public Health Fund to fund the 21st Century Cures Act, a continuation of the Republican attack on the ACA. Since 2000, Representative Fred Upton has received pharmaceutical contributions in excess of $1 million according to Open Secrets Org.

Besides weakening the testing of new pharmaceuticals, the 21st Century Cures does “nothing” to fight the rising cost of pharmaceuticals. Henry Azar took Eli Lilly’s Humalog diabetes drug and increased the pricing of it from $2,657.88 per year to $9,172.80 per year. After acquiring Vimovo, Horizon Pharma increased the price of it from $138 to $2,979 per 60-pill bottle. This is not the end of the story with Horizon. They will sell to customers at a much lower price and bill insurance at the higher price. Turing Pharmaceuticals Martin Shkreli bought the rights to the 62 year old drug Daraprim and immediately increased the price for it from $13.50 to $750 a pill. The same as other drugs, EpiPens will also rise and fall in price at the discretion of its manufacturer with little regard for actual cost.

In the December 15, 2015 JAMA publication, an article (Industry-financed Clinical Trials on the Rise as the Number of NIH-funded Trials Falls) by Stephan Ehrhardt, MD, MPH1; Lawrence J. Appel, MD, MPH2; Curtis L. Meinert, PhD suggests a growing influence of clinical trials conducted by companies with a vested interest in the outcome and a dilution of the impact of government-funded trials. “The number of newly registered trials doubled from 9,321 in 2006 to 18,400 in 2014 (Table 1). The number of industry-funded trials increased by 1965 (43%). Concurrently, the number of NIH-funded trials decreased by 328 (24%).”

While results from NIH-funded clinical trials are more apt to provide the basis for prevention and treatment recommendations; industry-backed studies can produce biased results leading to an increased concern for patient safety. Such was the case with Johnson & Johnson and Bayer’s anticoagulant Xarelto. Data was withheld during its industry-sponsored trial that would have deemed it less safe than traditional warfarin. It was approved without an antidote to bleeding complications in 2011. Thousands of Xarelto lawsuits have been filed against the manufacturer because of the medication’s severe internal bleeding complications.

NIH trials are down by 24% and commercial trials are up 43% many (71%) of which were also foreign funded. Funding for the NIH has fallen 14% since 2006 when adjusted for inflation and will decrease more as adequate funding has not been provided for the 21st Century Cures Act.

In a letter to Democrats Reid and Pelosi from various organizations, it was asked the 21st Century Cure Act be delayed until such time as rising prescription prices are addressed. “ Moving forward with this legislation now would be a missed opportunity to address unaffordable prescription drug prices. There is no justification for moving forward with legislation providing substantial benefits to the drug industry without achieving something in return.”

Again, pharmaceutical company lobbying Congress plus efforts by people such as Michigan’s Representative Fred Upton, has helped the industry reap substantial government sponsored benefits with little reciprocation in lower pricing. Michigan Representative Fred Upton was also the recipient of $597,000 from the Pharmaceutical/Healthcare Industry from 2014 into 2018. The initial bill was started in 2014.

With the 21st Century Cures Act underfunding of the NIH, increased commercial funding of clinical trials, and the relaxing of the need for clinical trials; can the pharmaceutical industry be counted on to be diligent in its testing of new products using “a lower level of evidence than the gold standard, which is randomized controlled trials” (Public Citizen’s Michael Carome)?

It appears the provisions of the 21st Century Cures Act are another stepping stone leading to the erosion of the ability of the FDA to certify the safety of new drugs and their manufacture which began in 1992 with the Prescription Drug User Fee Act (PDUFA). This allowed pharmaceutical companies to pay user fees to the agency in exchange for speedier reviews of their products. The new fees comprise 42% of the FDA’s budget today having grown from 8.5% in 1997. Companies would not be paying these fees if there were not a return for the cost in the market.

One might not think this would increase the danger the safety of new drugs; however, the 10-month time limit assessed does have its negative results. “For every 10 month of reduced review time, there is a correlated 18% increase in serious adverse reactions, 11% increase in hospitalizations, and 7% increase in deaths related to an approved drug.”

How Pharma Avoids Following the Law and the Penalties

The cost of doing business in pharmaceuticals includes paying the fines resulting from getting caught promoting drugs improperly or illegally. There are many prescriptions being written for Opioids for which there are alternate treatment strategies. When challenged, the industry and spokes people are quick to react to any calling for different strategies or limitations of usage.

For example, in 2001 Pfizer’s was ready to put Bextra on the market as a new class of painkillers known as Cox-2 inhibitors, supposedly safer than generic drugs, many times more expensive as ibuprofen, and translating into higher profits. Late in 2001, the FDA placed a qualifier on the use of Bextra for patients with extreme pain. The FDA found it was not safe for people with a risk of heart attacks or strokes and limited the usage of Bextra to people with arthritis and menstrual cramps.

This did not stop Pfizer and its partner Pharmacia from marketing Bextra as safe to use up to a 40 mg dosage. The same as what many healthcare insurance companies do with using doctors for approval of prescription, the companies hired expert doctors. Except these doctors in sales were to call on and convince other doctors (customers) of the safety of Bextra. After all, who argues with a doctor of medicine? Pfizer and its soon to be owned partner pushed the envelope with their claims of safe usage.

In the end what prevented Pfizer from a severe punishment was its size and the many other Pfizer drugs sold to and used by Medicare, Medicaid, and more then likely the VA. “Any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.” The punishment stopped at fines for the illegal selling of a dangerous drug with Pfizer, again a TBTF or Too Big To Ban scenario? To comply with the law; the newly incorporated Pfizer subsidiary Pharmacia & Upjohn Co. Inc., on the same day prosecutors and Pfizer agreed Pharmacia would plead guilty, was banned from billing Medicare or Medicaid. Pfizer continued to do business as normal. Pharmacia & Upjohn Co. Inc. took the fall not once for Pfizer but twice and Pfizer walked away unscathed except for a fine.

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The Risk of Opioid Addiction

I have been writing on healthcare for a while now and started to look at various topics with regard to pharmaceuticals. In my researching other topics, I found this particular correspondence to the Editor of the New England Journal of Medicine. Illuminating, if one might call it such? “A 1980 Letter on the Risk of Opioid Addiction

The NEJM published 1980 letter:

Addiction Rare in Patients Treated with Narcotics

Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction. Jane Porter; Herschel Jick; MD Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Waltham, MA.

In a more recent June 1, 2017 letter to the NEJM editor, the authors dealt with the broad based and undocumented assumption in the 1980 letter of Addiction Rare in Patients Treated with Narcotics and the realization of the addiction and deaths of many people using Opioids. “from 1999 through 2015, more than 183,000 deaths from prescription opioids were reported in the United States and millions of Americans are now addicted to opioids.” Signed by four researchers exploring the reasons why Opioid addiction and deaths have risen, one of the conclusions reached was doctors being told “the risk of addiction was low when opioids were prescribed for chronic pain.” Supplementary Appendix.

From the 2017 correspondence to the Editor entitled; “A 1980 Letter on the Risk of Opioid Addiction,” the authors, by utilized bibliometric analysis of data derived from the number of citations of the 1980 letter from the date of its publication until March 30, 2017. The authors analyzed the relationship between the 1980 letter and it’s conclusion(s) with other document’s conclusions citing the 1980 letter. The analysis can be seen in Figure 1.

608 citations of the 1980 letter were identified (Figure 1) of the index publication. Also noted was a sizable increase in citations after the introduction of OxyContin (a long-acting formulation of oxycodone) in 1995. 439 (72.2%) authors of articles cited the 1980 letter as evidence addiction was rare in patients treated with opioids. 491 (80.8%) authors of articles did not note the patients described in the letter were hospitalized at the time they received the prescription and left readers to assume these were out-patients. As an aside to the citation of the letter, some authors grossly misrepresented the 1980 letter’s conclusion(s) in various comments as shown in Section 3, Supplementary Appendix. In comparison to the 1980 letter citations, the researchers also compared the number of times other letters published in the NEJM were cited: “11 other stand-alone letters taken from the same time period were cited at a median of 11 times.” To be redundant, the 1980 letter was cited 608 times.

The researchers concluded:

a five-sentence letter published in the Journal in 1980 was heavily and uncritically cited as evidence that ‘addiction was rare with long-term opioid therapy.’ Furthermore, they believed the citation pattern contributed to the North American opioid crisis by helping to shape a narrative lessening prescribers’ concerns about the risk of addiction associated with long-term opioid therapy. In 2007, the manufacturer of OxyContin and three senior executives pleaded guilty to federal criminal charges they had misled regulators, doctors, and patients about the risk of addiction associated with the drug. Our findings highlight the potential consequences of inaccurate citation and underscores the need for diligence when citing previously published studies.”

As I have been doing my research on another piece to which this is almost a prelude to it, I have found an overwhelming resistance to any type of control being placed on prescriptions for Opioids of which there are limitations on the number of days a prescription is given for short term pain. The naysayers always go back to the issue of chronic pain.

Whereas one perspective written in the NEJM Reducing the Risks of Relief — The CDC Opioid-Prescribing Guidline comes right out and states; “The few randomized trials to evaluate opioid efficacy for longer than 6 weeks had consistently poor results. In fact, several studies have showed that use of opioids for chronic pain may actually worsen pain and functioning, possibly by potentiating pain perception. A 3-year prospective observational study of more than 69,000 postmenopausal women with recurrent pain conditions showed that patients who had received opioid therapy were less likely to have improvement in pain (odds ratio, 0.42; 95% confidence interval [CI], 0.36 to 0.49) and had worsened function (odds ratio, 1.25; 95% CI, 1.04 to 1.51).”

The resistance to quantity limitations of Opioid prescriptions for non-chronic pain can be felt strongly in both state and federal legislatures by pharmaceutical companies lobbying. In a ten-year period from 2006 to 2015 Pharmaceutical companies have spent $880 million in lobbying all 50 state legislatures and in making campaign contributions in an effort to prevent laws restricting Opioid prescription quantities. In the end, it is just a matter of profits disguised as concern for chronic patient pain care.

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David Dayen reminds us opioid emergency ends in a couple weeks

Lest we forget:

opioids-epidemic-trump-addiction-emergency-order-335848?c=63fe1379-3c99-4c6a-94d6-c58ac49ca11e" target="_blank" rel="noopener noreferrer">Politico notes today that the 90-day emergency declared actually ends in a couple weeks, and we’re in essentially the same place that we were before the declaration.
Trump has not formally proposed any new resources or spending, typically the starting point for any emergency response. He promised to roll out a “really tough, really big, really great” advertising campaign to spread awareness about addiction, but that has yet to take shape. And key public health and drug posts in the administration remain vacant, so it’s not clear who has the authority to get new programs moving.

A senior White House official said that the president has used the “bully pulpit” to bring urgency to the crisis, and if there’s one thing you want for your cause these days, it’s Donald Trump talking about it. Also it’s the equivalent of thoughts and prayers. By the way, Congress hasn’t really appropriated anything either, so this is a whole-of-government neglect.

Meanwhile, there’s a class divide among those suffering. Those with the means can get better treatment, in New York City and likely nationwide. The poor have to line up for their methadone treatment every day, putting extreme hassle into their lives.

The story is that an epidemic affecting white people would lead to a far more robust response than one that only affects minorities. With the opioid epidemic that’s only partially true.

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