CVS limiting meds on formulary to those “ESTIMATED” to be cost-effective

Posted on September 17, 2018 by Pharmaciststeve

CVS To Restrict Patient Access Using Cost-Effectiveness: Too Much, Too Soon

https://www.healthaffairs.org/do/10.1377/hblog20180913.889578/full/

Recently, CVS Health announced a new formulary management option: allowing self-insured employers to remove from their formularies medicines launched at a price greater than $100,000 per quality-adjusted life-year (QALY). The New York State Drug Utilization Review Board has also recently used a cost-effectiveness threshold to justify its mandate for the Medicaid program to receive a steep discount on the price of a cystic fibrosis treatment. If the discount is not obtained, access to the drug will likely be limited. Both CVS and the New York State Board based these decisions on cost-effectiveness estimates from the Institute for Clinical and Economic Review (ICER). Although there is strong support for the movement toward value-based care and prices, the CVS option and New York’s decision for its Medicaid program are too much too soon and could hamper patients’ access to needed medicines, for the reasons described in this post. 

First, cost-effectiveness is an element of value, but it is not synonymous with it. Multiple groups in the US, such as the ICER, the American Society of Clinical Oncology, the National Comprehensive Cancer Network, the Innovation and Value Initiative, and Faster Cures, among others, have proposed value assessment frameworks. None uses cost-effectiveness as the sole measure of value. To fully assess the value of a treatment, stakeholders must account for other considerations important to patients. Examples of these other considerations include: a new therapy’s ability to treat a previously inadequately treated illness; its ability to broaden therapeutic options for diseases with great variability in treatment response; the possibility of cure and the importance of hope related to it; the ease of a regimen when alternative therapies are complex, cumbersome, and time consuming; or, its novel mechanism of action that could lead to markedly improved derivative treatments. Although the National Health Service (NHS) in the United Kingdom bases many of its coverage decisions on the National Institute for Health and Care Excellence’s cost-effectiveness assessments, even it incorporates other considerations, and the strict NHS approach has not garnered real support from stakeholders in the US. 

Second, the CVS program uses a threshold of $100,000 per QALY and likely will use a health system perspective that does not incorporate the economic value of improvements in productivity or reductions in caregiver burden. The scholarly, Second Panel on Cost-Effectiveness in Health and Medicine, which provided the latest broad overview of how these assessments should be performed, has emphasized the importance of considering not just the health system perspective but also the broader societal one, which incorporates these indirect benefits. Moreover, the CVS plan has a single economic threshold ($100,000). In contrast, ICER’s value framework – which has the greatest focus on cost-effectiveness among all the frameworks — has a variable threshold (sometimes $100,000, other times $150,000) based upon the other considerations beyond the cost-effectiveness listed above. Evaluating all therapies for all diseases under all circumstances with a single threshold is an inappropriately blunt approach. CVS mentions that its approach will not apply to medicines deemed “breakthrough therapies” by the Food and Drug Administration (FDA). If CVS believes that the breakthrough designation connotes important non-economic considerations, then why just consider the FDA designation and not the factors above? 

Third, CVS proposes a dichotomous view of a treatment’s value. If the cost-effectiveness assessment is below $100,000 per QALY, then the formulary would include the medicine, and if the assessment exceeds the threshold, it would not. What about medicines with a cost-effectiveness of $105,000 per QALY? Premera Blue Cross uses cost-effectiveness in constructing its formularies but has a more nuanced approach. The company ties formulary tiers, and thus copayments, to cost-effectiveness. Rather than denying patient access, Premera makes a broader set of medicines available but adjusts how much the patient pays for medicines it deems to have lower economic value. 

Fourth, by making a dichotomous formulary access decision based upon a single cost-effectiveness number, CVS presupposes that all patients respond in the same fashion to a therapy. There is substantial literature demonstrating heterogeneity of treatment effect, which means that for the same treatment, some patients benefit far more than the average. The CVS approach ignores this important clinical component. 

Finally, in allowing its clients to use ICER’s cost-effectiveness assessment as the sole source of data to support formulary exclusion, CVS assumes that the field of value frameworks is fully mature, has addressed the many limitations of the QALY, and is ready for prime time, which it is not. Last year in a Health Affairs blog, we identified six key considerations for the improvement of value frameworks, as follows:

  1. Value assessments should be separate from assessments of budget impact and affordability.
  2. Value assessments should incorporate what is important to patients, even if the end user for a framework is the payer.
  3. Value assessments should adopt broad system perspectives in what they assess and how they assess it.
  4. Value is dynamic and needs to be considered and captured as such.
  5. Value assessments should be transparent and reproducible.
  6. A diversity of value assessment approaches that reflect the differing needs of stakeholders should remain; value assessments should reflect user preferences. 

Prices should reflect value, and concerns about health care spending should move us toward incentivizing high-value interventions and dis-incentivizing low-value care. However, the announcement from CVS, perhaps well intentioned, is too much too soon.

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McCaskill is apparently CLUELESS about ADDICTION and DEPENDENCY ?

Posted on September 17, 2018 by Pharmaciststeve

‘No question my mom was addicted to opioids,’ McCaskill reflects during roundtable

https://www.kansascity.com/news/politics-government/article199431699.html

U.S. Sen. Claire McCaskill thinks her mother was addicted to opioids before she died.

McCaskill, a Missouri Democrat, hosted a health care roundtable Friday afternoon at St. Luke’s Hospital.

The roundtable with Kansas City physicians and other medical professionals covered topics including the cost of emergency room care, the impact of Missouri’s decision to not expand Medicaid and problems in the state’s mental health system.

McCaskill also devoted several minutes to the highly personal topic of opioid addiction and the intensive outpatient treatment programs that exist in her neighborhood. 

“There’s no question my mom was addicted to opioids near the end of her life,” said McCaskill, whose mother, Betty Anne McCaskill, died in 2012 at age 84.

She recalled how her mother often told her doctors that her pain was at a 10 on 1-to-10 scale to get the strongest dose of medication during her final years.

“It was one of those gut-wrenching things because it felt like I knew it was not helping her. On the other hand, to try and get her off those drugs at that point in her life also seemed like a cruel and sometimes painful thing to get done,” McCaskill elaborated to reporters after the event.

“And frankly some of the times she was in the most pain was when she was going through withdrawals. She wanted the drugs because she was coming off of the drugs … and all of them were prescribed with her doctors.”

Marc Larsen, the chair of emergency medicine at St. Luke’s, told McCaskill the medical community “created this epidemic by saying we have to treat the pain.”

McCaskill, who has led an investigation into opioid manufacturers, floated the idea of broadening her investigative efforts into the rest of the pharmaceutical industry. She repeatedly expressed her concern about the links between drug companies and research organizations that tout the benefits of medication.

Another area of focus during the discussion was the state of mental health care in Missouri.

McCaskill was shocked to learn that the largest mental health care provider in the state is the Department of Corrections. She was also surprised to learn that Missouri incarcerates women at a higher rate than any other state.

“Are women meaner in Missouri?” she quipped.

After the meeting, she blamed both of these statistics on the state’s “failure to have wrap-around health services, mental health services, behavioral health services for many of the underinsured and uninsured in our state.”

“There’s no question my mom was addicted to opioids near the end of her life,” said U.S. Sen. Claire McCaskill, whose mother, Betty Anne McCaskill, died in 2012 at age 84. Bryan Lowry blowry@kcstar.com
Another person with a LAW DEGREE making medical opinions and decisions. McCaskill is up for RE-ELECTION in November.. She has been in the Senate for 18 yrs… Is it time for some TERM LIMITS being applied to her ?
According to her comments in this article it would appear that she does not understand the difference between ADDICTION and PHYSICAL DEPENDENCY and if her Mom was still alive today… she would be insisting that she did not take opiates for her chronic pain.

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THEFT from the American people under cover of “universal coverage!”

Posted on September 16, 2018 by Pharmaciststeve

ATTN USA!  “Health” Insurance companies are limited to 15% profit margin, BUT their PBM’s can take 70% profit! Insurance company/PBM mergers are taking place right under our noses! Absolute THEFT from the American people under cover of “universal coverage!”

 

 

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Heroin/Illegal Fentanyl OD’s DOWN… Meth, Cocaine, Marijuana use UP

Posted on September 15, 2018 by Pharmaciststeve

New Heroin User Numbers Are Dropping Amid A Fatal Overdose Epidemic

https://www.buzzfeednews.com/article/danvergano/heroin-use-drops

Amid staggering numbers of fatal US drug overdoses, fewer people started using heroin in 2017 — the numbers dropping by more than half — a new federal survey suggests.

The Substance Abuse and Mental Health Services Administration (SAMSHA) on Friday released its long-running National Survey on Drug Use and Health (NSDUH), which surveys illicit drug use nationwide.

The yearly survey’s results are the vital signs of a nationwide drug overdose epidemic that killed around 70,000 people last year and was declared a national public health emergency by President Trump.

About 44,000 of those deaths came from heroin and related synthetic opioids such as fentanyl, which is many times more potent with notorious overdose risks. According to the group, which surveyed more than 60,000 people, there are about 500,000 people in the US who are users of heroin.

It’s possible that these high fatal overdose numbers are starting to sink in with illicit drug users. Last year, the number of new heroin users in the US dropped by 53% to 81,000 people, according to the survey’s findings. That’s down from 170,00 in 2016.

The survey also found “a significant increase” in people receiving specialty treatment for illicit drug use disorders. “This was particularly evident for those with heroin use disorder and opioid use disorders,” according to a SAMSHA summary of the findings.

“Great news,” medical epidemiologist Daniel Ciccarone of the University of California, San Francisco, told BuzzFeed News.

Drug users aren’t happy with the increase in fentanyl — a highly potent synthetic opioid that’s often mixed into heroin and is the cause of many overdoses — showing up in their drug supply, which could lead to fewer people starting on heroin in the first place, he added.

While deadly drugs like fentanyl can discourage new drug users, these opioid drugs are also responsible for strong physical dependencies in existing users, making it harder to kick the habit. This could extend the duration of the current overdose epidemic far longer than we’ve seen with previous epidemics.

“Availability of treatment is a crucial factor,” Ciccarone said, in allowing a decline in the overdose epidemic to take hold. Only about 1 in 3 people in drug treatment programs receive medication-assisted treatment, the most effective way to treat addiction disorders.

CDC / Via cdc.gov

Some preliminary CDC data suggests that total drug overdoses have plateaued in the last year, driven by a decline in heroin and painkiller deaths; however, in the same time period, fentanyl deaths have continued to increase. A recent Blue Cross Blue Shield report found a 5% drop in clients reporting opioid use disorders as well.

Andrew Kolodny of Brandeis University told BuzzFeed News by email that the drop in new heroin users was “very good news,” not just for the sheer numbers, but also because it runs contrary to the theory that more people would turn to heroin as doctors became more cautious about prescribing opioid painkillers.

“The reason deaths have soared in illicit opioid users is because the illicit opioid supply became much more dangerous,” because of fentanyl, Kolodny said. “The new [survey] data makes this easier to see.”

While heroin use may be on a decline, there were some concerning upticks found in the survey. Methamphetamine use was found to be more popular among young adults 18 to 25 years old and pregnant women reported more opioid, cocaine, and marijuana use.

Despite it looking like things are heading in the right direction with the drop in new heroin users, the number of overdose fatalities remains “unacceptably high,” Ciccarone said.

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Could pet/animal abuse change the course of the DEA and war on drugs ?

Posted on September 14, 2018 by Pharmaciststeve

Wedgewood Pharmacy Survey Demonstrates Negative Impact of Opioid Shortages on Veterinarians, Pet Owners, and Pets

http://www.thecourierexpress.com/business/wedgewood-pharmacy-survey-demonstrates-negative-impact-of-opioid-shortages-on/article_69b24b26-1e39-5a80-9168-dc25cad11fa5.html

SWEDESBORO, N.J.–(BUSINESS WIRE)–Sep 14, 2018–A nationwide survey shows that there are unintended consequences for veterinary medicine caused by the Drug Enforcement Administration’s (DEA) efforts to address the national opioid crisis. Opioids in animal medicine are the foundation, and often the only method, of pain control and anesthesia. They are critical for the treatment of animals that have been hit by a car, shot by a gun, mauled by another animal, undergone surgery, or suffer from a severe disease or other trauma. Most pet owners, regulators, elected officials, and state board of pharmacy members are not aware of the repercussions.

To address the mis-use and diversion of opioids by people, the DEA has proposed an average 10 percent decrease in the 2019 manufacturing quotas for six frequently abused opioids, including five key Class II opioid drugs commonly used by veterinarians. DEA decreased allowable opioid manufacturing quotas by 25 percent in 2017 and 20 percent this year. When supplies of these drugs are limited, manufacturers and distributors give preference to allocating their limited supplies for use in human health, creating shortages for veterinary medical practitioners. For example, in August, Pfizer suspended delivery of injectable opioids to veterinary customers.

According to the survey, these shortages have had the unintended results of creating unnecessary pain, suffering, and death of animals because alternatives are less effective and are more expensive.

Key findings of the survey:

In the past year, from 27% to 73% of veterinary professionals have had difficulty obtaining necessary supplies of five opioids they consider “important to your practice and to your patients’ health” by 50% – 80% of respondents. They include Hydromorphone, Morphine, Fentanyl, Hydrocodone, and Oxymorphone.Shortages of these opioids have caused … The use of less effective, non-narcotic alternatives such as NSAIDS (83%);Increased patient suffering (71%);Use of a local anesthetic (49%);Postponed procedures (26%); andPatient deaths (3%)88% of respondents “rarely” or “never” see the four warning signs published by DEA that a client is potentially abusing opioids. Nevertheless, 63% “have training and/or procedures in place for medical and other staff members to recognize the signs of opioid abuse.”

The survey was conducted in September by Wedgewood Pharmacy, the largest animal-health compounding pharmacy in the U.S. The invitation to participate went to 53,968 veterinary professionals; 1,135 completed the survey. The results (which include hundreds of write-in comments from veterinarians) will be included in formal comments that the company will submit to the DEA regarding the proposed production quota reductions. [DEA will be accepting comments at http://www.regulations.gov until 11:59PM, September 19, 2018. Please reference ‘‘Docket No. DEA–488P’’ on all correspondence, including any attachments.]

Michael Blaire, R.Ph., FIACP, vice president, Government and Regulatory Affairs noted, “Shortages limit therapeutic choices and are especially problematic given the number of species veterinarians treat—from tiny kittens to large dogs, horses, and even elephants—and how different species react to opioids or their alternatives. Shortages demand that veterinarians frequently change medications and pain-management protocols, and this increases the risk of medical errors. While we applaud DEA’s efforts to address the national opioid crisis among humans, we’re asking them to be thoughtful about the impact the actions they take will have on the animal patients owned by 68% of American homes and the millions of animals in zoos, aquaria, stables, shelters, hospitals, research facilities, police and military facilities. We need to work together to address a national crisis in human health while continuing to provide veterinarians with the medicines they need to practice.”

One veterinarian wrote this comment to illustrate how opioid shortages affect his or her patients: “We have an emergency practice, so we see a lot of very painful animals from surgeries, traumas, and severe illness. Most of our patients in acute pain are not candidates for NSAIDS or other treatments like laser and acupuncture, which take longer to work and are not proven effective for severe pain. Not having access to opioids almost makes treatment cruel.”

Wedgewood Pharmacy and recently acquired Diamondback Drugs are licensed by DEA to manufacture controlled substances, which they do exclusively for animal patients. Compounded medications are created and prepared by specially trained pharmacists and pharmacy technicians in nationally accredited, state-regulated facilities, when mass-manufactured drugs are not available or appropriate for a patient. These medications are prescribed and dispensed under orders written by veterinarians. At least one facility has experienced difficulty obtaining the quantities of active pharmaceutical ingredients needed to meet the demands of their veterinary customers, because of purchasing quotas set by DEA.

The sampling of participants in the survey was participant-driven, not random, and therefore measures of statistical significance such as confidence levels and sampling error do not apply to the results of the study. They represent the opinions of the professionals who participated.

About Wedgewood Pharmacy

In its 37 years, Wedgewood Pharmacy has grown from a local community pharmacy to become one of the largest compounding pharmacies in the United States; it is the leading pharmacy in animal health. Wedgewood Pharmacy serves more than 50,000 prescribers and hundreds of thousands of patients throughout the U.S. every year.

George (late) and Lucy Malmberg, both pharmacists, purchased Wedgewood Pharmacy in 1981; the pharmacy was founded in 1980. In June 2016, Chicago-based New Harbor Capital became the majority owner of the company. In July 2018, the company acquired Diamondback Drugs, Scottsdale, Arizona.

Wedgewood Pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB ® ) for compliance with PCAB and other nationally recognized compounding standards. PCAB was formed by eight of the nation’s leading pharmacy associations and is a service of Accreditation Commission for Health Care. As a third-party accreditation organization, PCAB has developed the highest national standards against which providers are measured to demonstrate their ability to effectively and efficiently deliver quality compounded medications to consumers. Wedgewood Pharmacy employs more than 500 people in its state-of-the-art compounding pharmacies in Swedesboro, New Jersey and Scottsdale, Arizona.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180914005480/en/

CONTACT: Wedgewood Pharmacy

Michael Blaire, R.Ph., FIACP

Vice President, Government and Regulatory Affairs

MBlaire@WedgewoodPharmacy.com

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Blue Cross not following the laws and denying pain management

Posted on September 14, 2018 by Pharmaciststeve

Incredible news to share:
After my insurance decided to not cover my rx last week, they said that they needed a pre-authorization. I’ve been on the same rx and dose for eight years. Then, after my doctor filled out all the extra paperwork the following day, I was informed that they did not approve the pre-authorization. 😤

So. I got to work and started researching their policies and what laws they were basing them on.
I found a very specific law passed last year that implicitly states that I am a patient who is grandfathered into the plan and should not be held to new standards.
I got all of my information printed, hi-lighted, and ready for a fight. I called to speak with a specialist and supervisor.
I was getting the basic speech that is read off a script or training manual.
I kept my cool, then went in with all of the facts. I started quoting laws and policies, explaining how that affected me, and how we needed to fix the error and adhere to the state and federal laws, and bcbs policies.

They asked for this information again, as they were taken aback. I sent it to them, personally, in an email. I explained exactly what I expected and why I had a legal right to it. I quoted laws. I provided links to laws as well as to bcbs pages that applied those laws to new rules and policies. I explained that I was only one of many millions who are experiencing discrimination over this issue. I explained that we expect a change in our treatment and that we would prefer to settle these issues of abuse and discrimination outside of court, if possible.

Well. I got everything I asked for. Not only that, but they were so thankful for the information I sent. They’d never been taught about those laws and policies, or how they apply. And they certainly were not trained to counsel patients who call in crying because their medications are no longer covered, and they didn’t know until they showed up at the pharmacy to pick up their meds.
They said that out of the thousands (yes, thousands) of calls they’ve received at that call center in the past few weeks, I’m the only person who has ever presented any information like that.
They have since, in the last week, explained this information to all of their employees, printed it out, and now have a way to try and actually help patients who call. It’s implementation starts today!

I’m so excited for this!!!
Now, if getting the government to use their brains on this matter were as easy…..
But I have momentum now, and I’ve set a precedent. I will followup and follow through!

 

here is contact information for the poster of this information  https://www.facebook.com/laura.orlando.545

 

 

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AIM study suggesting 9% of US suicides are associated with chronic pain

Posted on September 14, 2018 by Pharmaciststeve

http://annals.org/aim/article-abstract/2702061/chronic-pain-among-suicide-decedents-2003-2014-findings-from-national

https://uk.reuters.com/article/us-health-pain-suicide/chronic-pain-may-contribute-to-suicide-study-warns-idUKKCN1LQ2L6

https://www.eurekalert.org/pub_releases/2018-09/acop-cpm090418.php

 

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Guess who really started the “opiate crisis” ?

Posted on September 14, 2018 by Pharmaciststeve

2001 to 2010: The Decade of Pain Control and Research

https://lifeinpain.org/node/141/

Decade of Pain Control and ResearchGlenview, IL – October 31, 2000 –

The 106th U.S. Congress passed H.R. 3244 and President Clinton signed this bill into law. Title VI, Sec. 1603, provides for the “Decade of Pain Control and Research,” to begin January 1, 2001.

The 106th Congress was Republican controlled and Pres Bill Clinton (D) signed the above law.

This is only the second Congressionally declared medical decade, the first being the Decade of the Brain in the 1990s.

With this designation, brought about through the efforts of the American Academy of Pain Medicine, the American Headache Society, and the American Pain Society, it was hoped that public attention and funding for research would be focused on an under-recognized but very serious issue.

Pain lacks a significant constituency at the federal level, resulting in a lack of investment in research, education, and treatment. This Congressionally declared “Decade” will bring a much-needed focus on pain to both the public and private sectors, and is a first step in stimulating further progress in research, education and clinical management.

This is a major accomplishment for the Pain Care Coalition, and great credit is due to both Philipp M. Lippe, MD for originating the idea and to Michael Ashburn, MD for his diligent work with Senator Orrin Hatch and his staff to enact this law. Dr. Lippe serves as the Executive Medical Director for the American Academy of Pain Medicine.

The Pain Care Coalition is a national coalition that advocates for responsible pain care policies at the federal level. The Coalition was formed in 1998 by the American Academy of Pain Medicine, the American Headache Society, and the American Pain Society.

Back in 1914, the Democratic controlled Congress and signed into law by Pres Woodrow Wilson (D)…  https://en.wikipedia.org/wiki/Harrison_Narcotics_Tax_Act

“The act appears to be concerned about the marketing of opiates. However a clause applying to doctors allowed distribution “in the course of his professional practice only.” This clause was interpreted after 1917 to mean that a doctor could not prescribe opiates to an addict, since addiction was not considered a disease. A number of doctors were arrested and some were imprisoned. The medical profession quickly learned not to supply opiates to addicts. In United States v. Doremus, 249 U.S. 86 (1919), the Supreme Court ruled that the Harrison Act was constitutional, and in Webb v. United States, 249 U.S. 96, 99 (1919) that physicians could not prescribe narcotics solely for maintenance.“

“The act also marks the beginning of the creation of the modern, criminal drug addict and the American black market for drugs. Within five years the Rainey Committee, a Special Committee on Investigation appointed by Secretary of the Treasury William Gibbs McAdoo and led by Congressman T. Rainey, reported in June, 1919[25] that drugs were being smuggled into the country by sea, and across the Mexican and Canadian borders by nationally established organisations[26] and that the United States consumed 470,000 pounds of opium annually, compared to 17,000 pounds in both France and Germany.[25] The Monthly Summary of Foreign Commerce of the United States recorded that in the 7 months to January 1920, 528,635 pounds of opium was imported, compared to 74,650 pounds in the same period in 1919″

In 1970 The Controlled Substance Act was passed by a Democratic controlled Congress and signed into law by Pres Richard Nixon (R).  https://en.wikipedia.org/wiki/Controlled_Substances_Act

which created the structure to “deal with” – declare war on drugs – to deal with the illegal drug market that Congress had created some 50+ year earlier.

according to this  Methadone treatment centers started in the mid-60’s  https://www.narconon.org/drug-information/methadone-history.html

“By the mid-1960s in New York City, the rapid spread of disease from one addict to another called for a drastic solution. Researchers at the Rockefeller Foundation developed a system of dosing heroin addicts with methadone to prevent their use of heroin.”

Since this was before the existence of the DEA, the DEA may have been forced to create some sort of licensing of these Methadone treatment centers and thus the same judicial system that declared that opiate addiction was a crime and not a disease was now issuing licenses to treat the “crime of opiate addiction” with a medication

Those of us in healthcare were under the understanding that the “decade of pain” was a result of the Joint Commission https://www.jointcommission.org/ declaring that “pain” was the fifth vital sign and was now a MAJOR STANDARD for hospitals and nursing homes to get/maintain accrediation under the JC.

It would appear now that since we have a “opiate crisis” they are disavowing any connection to that decade of pain and fifth vital sign.

so it would appear that Congress has been the major driving force behind the “opiate crisis” over the last 100 + yrs and the pharmas that produced the various opiates and prescribers that prescribed those same opiates are just minor contributors to the the crisis… if there is even a crisis… .because the majority – and increasing – of OD’s in recent years involves illegal Heroin and Illegal Fentanyl being imported from China and Mexico.

 

 

 

 

 

 

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Real Facts Behind the “Opioid Crisis” and the Abandonment of Pain Patients

Posted on September 13, 2018 by Pharmaciststeve

This is from a national DPPR member for a handout. The Real Facts Behind the “Opioid Crisis” and the Abandonment of Pain Patients:
● Andrew Kolodny and Physicians for Responsible Opioid Prescribing – PROP (addiction specialists with no
experience treating pain) petitioned the FDA in 2012 to change opioid manufacturing guidelines for patients with
non-cancer pain, asking FDA to limit dosing to 100 MED and limit treatment to 90 days. FDA denied this request
in 2013 due to a lack of scientific evidence to support limiting usage or dosage and no evidence to suggest cancer
pain is different from non-cancer pain. Most patients treated with opioids on higher doses and long term
treatment do well and live productive lives without addiction or death.
● 2014 – Illicit fentanyl was added to other illicitly manufactured drugs such as heroin, hydrocodone, xanax, etc.
Addicts buy their drug of choice on the street not realizing it has fentanyl in it. Fentanyl is 50-100 times stronger
than morphine. Addicts began dying in mass quantities catching the attention of the media and the government.
● DEA stepped up enforcement on doctors and pharmacies, threatening and prosecuting doctors for “over
prescribing” opioids to pain patients.
● CDC published the 2016 opioid death report which falsely claimed pain patients were addicted and dying in
massive numbers even though historically pain patients are rarely addicted or involved in opioid-related deaths.
● CDC contracted with members from the anti-drug lobbying group PROP to help draft CDC guidelines for opioid
prescriptions written by primary care physicians even though CDC and PROP knew that illicitly manufactured
fentanyl and heroin was the cause of the crisis. CDC Guidelines were implemented by the states as rule rather
than guidelines as originally intended, forcing pain patients off their medication or to a lower, non-therapeutic
dosage. This was done in spite of CDC having no prescription regulatory power and FDA already telling PROP
there is no scientific evidence to suggest these limitations are necessary or useful.
● Pharmacies and insurance companies began limiting opioid quantities and/or refusing to fill opioid prescriptions
based on perceived addiction bias against patients with pain from all causes due to media/government
misinformation, namely the original 2016 CDC opioid death report and guidelines.
● FDA cut production of opioids creating shortages and leaving many hospitals, cancer patients, and pain patients
without medication to treat pain.
● In 2018, CDC finally issued a correction for the 2016 opioid death report admitting that the majority of the deaths
were from illicit fentanyl and heroin, not legal prescription pain pills. CDC and National Institute on Drug Abuse
(NIDA) concede pain patients are almost never involved in opioid-related deaths. According to SAMHSA 2016
and similar studies the addiction rate for pain patients is .8%. That means 99.2% do not get addicted.
● Government/regulators ignore CDC and NIDA statements, continue threatening doctors. Many doctors stopped
treating pain patients and many closed their practice due to fear of losing their license or being prosecuted. Many
pain patients are left with no treatment for pain leaving them to suffer in agony with no support.
● NIH, FDA, DEA, CMS, Medical Boards, States abandon pain patients based on CDC’s initial report and guidelines
implemented as rule because of the false ideology CDC created. The majority of drug addicts continue to get
their drugs on the street and are still dying with no help. All pain patients, including cancer patients, blamed for
illicit fentanyl and heroin addiction/overdoses and continue to suffer needlessly. Production of opioids scheduled
to be cut again which will create even more shortages for the few patients still able to get meds and for hospitals.
CMS due to implement CDC guidelines as rule for Medicare and Medicaid patients in 2019.
● PROP stands to gain millions in federal money for addiction treatment that will likely never be fully utilized
because pain patients are the ones targeted yet most are not addicted. Most of the real addicts do not see
doctors unless they OD, thus little access to treatment.Pain patients and providers need your support! Please call your state and federal
legislators, the Medical Board of California, DEA, FDA, CMS, and media and tell them to
protect pain patients and their doctors from unfair discrimination. Tell the DEA to
leave our doctors alone! Tell them to remove the CDC guidelines and allow access to
opioid treatment as allowed by the manufacturer’s guidelines. Spread the word!
dontpunishpainrally.com
dontpunishpainrally.com/docs/
Resources
FDA Refuses PROP’s Request To Limit Opioid Dosage and Usage
http://paindr.com/wp-content/uploads/2013/09/FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribin
g_Partial_Petition_Approval_and_Denial.pdf
https://www.huffingtonpost.ca/marvin-ross/doctors-evidence-pain-patients_a_23371118/
PROP Involved in Drafting CDC Guidelines
https://www.painnewsnetwork.org/stories/2015/9/21/prop-helped-draft-cdc-opioid-guidelines
http://nationalpainreport.com/cdc-opioid-prescribing-guideline-unintentional-consequences-8836710.html
Illicit Fentanyl on the Rise
https://www.cdc.gov/drugoverdose/images/pbss/CDC-Fentanyl-overdoses-rise.pdf
https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
CDC Admits Death Data Inaccurate
https://ajph.aphapublications.org/doi/10.2105/AJPH.2017.304265
http://www.clinicalpainadvisor.com/opioid-addiction/the-issues-with-the-cdc-guidelines-on-opioids-for-chronic-pain/article/5
24976/
Pain Reliever Use Disorder – SAMHSA
https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.htm#opioid4
Cochran Report – Rate of Addiction Rare
https://www.cochrane.org/CD006605/SYMPT_opioids-long-term-treatment-noncancer-pain
Living with CDC Opioid Guidelines
https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/living-cdc-opioid-guidelines
https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/inhumane-dangerous-game-forced-opioid
-reduction
The Myth That Prescriptions Caused The Opioid Crisis
https://amp-newsobserver-com.cdn.ampproject.org/c/amp.newsobserver.com/

 

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Kolodny: “I think it’s a good idea”… taxing opiate prescriptions

Posted on September 12, 2018 by Pharmaciststeve

States Looking To Tax Opioids Pin Hopes On November Elections

https://khn.org/news/states-looking-to-tax-opioids-pin-hopes-on-november-elections/

After almost slapping a tax on makers of opioid pills earlier this year, Minnesota lawmakers are set to try again when they meet in January.

The drug manufacturers that helped create the opioid addiction crisis should help fix it, said state Sen. Chris Eaton, whose daughter died of an overdose.

“I’m definitely going to pursue it” in the next legislative session, said Eaton, a Democrat. “Whether it has a chance or not kind of depends on the election.”

Lawmakers in at least 10 other states intend to consider opioid taxes in upcoming legislative sessions. Many pin their hopes on the November midterm elections.

If Democrats retake governorships and legislatures this fall, lawmakers and policy analysts predict other states would be more likely to follow New York, whose groundbreaking opioid tax to raise $100 million a year took effect July 1.

November results “are absolutely going to drive some of this,” said Tara Ryan, vice president of state government affairs for the Association for Accessible Medicines, which represents makers of generic medications and opposes opioid taxes. “If the Democrats take the elections, like some people say they will, it could definitely change the votes.”

California, Delaware, Iowa, Kentucky, Maine, Massachusetts, Montana, New Jersey, Tennessee and Vermont are all eyeing renewed attempts to pass opioid taxes, officials in those states say. The proceeds would mostly pay for addiction treatment and prevention.

“We’ll be back come January,” said Tim Ashe, president pro tempore of the Vermont Senate, which overwhelmingly passed a tax measure this year that faded in the House and was opposed by the state’s Republican governor, Phil Scott, who is up for re-election.

New York’s law taxes manufacturers and distributors according to an opioid medication’s strength and will direct proceeds toward addiction treatment, prevention and education. The tax is expected to amount to roughly a dime per lower-strength opioid pill and higher for more powerful ones.

“I think it’s a good idea,” said Andrew Kolodny, an opioid-policy researcher at Brandeis University and frequent critic of the pharma industry. “The human and economic costs of these meds are enormous.”

Adding to the momentum is frequent support from Republicans, who are normally reluctant to tax businesses.

“I’m probably the No. 2 or 3 most conservative individual in the legislature, and I’m standing up there proposing a[n opioid] sales tax,” said Montana Republican Sen. Roger Webb.

But an industry backlash is growing. An association representing pharmaceutical distributors sued in July to block the New York law, arguing that those businesses were unfairly targeted.

Pharma’s main trade group has also fought hard against such measures, arguing they drive up the cost of medicine and unfairly penalize patients with chronic pain.

“We do not believe levying a tax on prescribed medicines that meet legitimate medical needs is an appropriate funding mechanism for a state’s budget,” said Priscilla VanderVeer, spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA.

New York’s law prohibits passing the tax on to consumers and other purchasers such as insurance companies, but enforcing that could be tricky, according to legal experts.

The Association for Accessible Medicines opposes all opioid taxes but especially objects to that measure because it taxes drugs per pill rather than according to revenue. That puts most of the burden on makers of cheap generics and largely spares brand-name sellers, whose marketing helped fuel the addiction crisis, Ryan said.

Drugmakers will prove to be tough opponents regardless of electoral outcomes, said Regina LaBelle, a visiting fellow at Duke-Margolis Center for Health Policy who worked on drug strategy in the Obama White House.

“These types of taxes face an uphill battle in state legislatures as powerful forces, including industry and industry-funded groups, ally against them,” she said. Pharma-funded chronic-pain patients can be a powerful lobby, she said.

Surging mortality rates caused by fentanyl, heroin and other illegal opioids give pharma companies a chance to deny blame, even if many of those victims became addicted through prescription pills, LaBelle said.

Drug overdoses killed more than 70,000 people last year, a record, according to new, preliminary estimates from the Centers for Disease Control and Prevention.

Dozens of cities, counties and states have sued opioid makers and distributors, arguing the companies downplayed the dangers of addictive pills and ignored signs they were being abused on a massive scale. Often compared to litigation against tobacco companies in the 1990s, the cases could produce billions of dollars in government revenue to fight addiction and overdose.

But that could take years. Through opioid taxes and related measures, states could quickly supplement addiction-prevention funds made available by Washington, which many consider inadequate and unpredictable.

Members of Congress have pushed more opioid legislation this summer, but the House’s package so far has no clear path to becoming law.

Federal funding “is a drop in the bucket,” said Patrick Diegnan, a Democratic New Jersey state senator who backed an opioid tax this year. “We really basically have to put in place the infrastructure for treatment. It will cost a lot of money.”

Minnesota’s proposed opioid tax had bipartisan support this year, passing the state Senate by a huge margin. But under heavy pressure from drug companies, a measure in the Republican-controlled house failed at the end of the legislative session in May.

In the governor’s race this fall, Tim Walz, a Democratic congressman, faces Jeff Johnson, a county commissioner who upset former Gov. Tim Pawlenty in the Republican primary.

Minnesota recently got Washington’s permission to bill Medicaid, the state and federal program designed for low-income people, for psychiatric hospital stays for those with intense addiction-treatment needs.

But none of the moves so far will furnish resources adequate to relieve the crisis, argue patient advocates. Many see an element of justice in making opioid companies contribute.

“Why is it important for the drug industry to pay reparations?” said Lexi Reed Holtum, executive director of the Steve Rummler Hope Network, a Minnesota advocacy group named for her fiancé, who died of an overdose in 2011. “No matter what, this is going to go on for decades to come.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Why doesn’t the DEA use all the money they confiscate from “bad guys” to help fund the treatment of those who are substance abusers ?

 

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