Andrew Kolodny on Chronic Pain – Kind Of

Andrew Kolodny on Chronic Pain – Kind Of

www.nationalpainreport.com/andrew-kolodny-on-chronic-pain-kind-of-8834549.html

By Ed Coghlan.

I spoke with Andrew Kolodny recently. The man who is aggressively pushing the idea of restricting or eliminating opioid usage has become the bane of many chronic pain patients.

The conversation was about a commentary we had published by Suzanne Stewart that he felt was unfair. We discussed what offended him and on a couple of matters he had a point (a couple of others, I didn’t think he did).

I hope that I’m reasonable and always try to be fair. So, I asked Suzanne – absent proof to the otherwise – to make a couple of changes, which she did, and we republished the story.

After Dr. Kolodny and I had discussed the issue he had with the story, I did a quick interview with him because I’ve not been able to get hold of him in the past (or as you’ll see, since).

I told him that he, no doubt, knew that chronic pain patients and patient advocates see him as an enemy.

He acknowledged that and said, “It is a common misunderstanding. I’m not trying to throw pain patients under the bus, I’m just very concerned about the opioid epidemic.”

He later stated that millions of chronic pain patients and many others have become addicted to opioids.

I shared with him that I believed the concentration on opioids had turned the debate into a binary one – opioids are bad or good, depending on your point of view – but little has been discussed about what should be done for chronic pain patients instead of opioids.

What I suggested to him was that he should write a blog for the National Pain Report aimed at pain patients and their advocates and providers that outlines his case against opioids, and importantly, what he would recommend be done for chronic pain patients if he’s successful in limiting or outlawing opioids.

He said, “I don’t think I would want to do that, but I’ll think about it.”

The days went on and I never heard back so, on September 23, I sent him the following email:

Dr. Kolodny,

Are you willing to write a piece for the National Pain Report?

I made the offer verbally in our phone call and wanted to follow up with a written invite.

Thanks,

Ed Coghlan

Haven’t heard back.

The offer stands.

Patient Advocates Call on Brandeis to Fire Kolodny

kolodny on CSPAN.jpg

Patient Advocates Call on Brandeis to Fire Kolodny

http://www.painnewsnetwork.org/stories/2017/10/3/patient-advocates-call-on-brandeis-to-fire-kolodny

A coalition of physicians, patient advocates and pain sufferers has written an open letter to Brandeis University asking for the dismissal of Andrew Kolodny, MD, a longtime critic of opioid prescribing who is co-director of opioid policy research at the university’s Heller School for Social Policy and Management.

Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that has lobbied politicians and regulators for years to enact stronger measures to limit prescribing of opioid pain medication.

“Dr. Kolodny has been prominent in a national campaign to deny chronic pain patients even minimal management of their pain.  His actions are directed toward forcing draconian restrictions or outright withdrawal of this class of medications from medical practice,” reads the letter to Brandeis President Ronald Liebowitz and other top administrators at the university.

“He calls for forced tapering of patients formerly prescribed opioids. Policy positions for which he advocates are leading to the deaths of hundreds of chronic pain patients by suicide or pain-related heart failure and medical collapse.”

The letter was drafted by Richard Lawhern, PhD, and signed by over 60 healthcare professionals and patient advocates, including pain management specialists Forest Tennant, MD, and Aimee Chagnon, MD. Lawhern is the corresponding secretary of the “Opioid Policy Correspondents List,” an ad hoc volunteer group that advocates for better pain care. The group receives no funding from outside sources.

To read the letter in its entirety, click here.

Kolodny is a controversial figure in the pain community and is often quoted in the news media as an expert on issues involving pain management, even though his professional background is in addiction treatment.  He often refers to opioid medication as “heroin pills” and has suggested that patients shouldn’t trust doctors who prescribe opioids.

“I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case,” Kolodny said on C-SPAN in 2015. “We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

“Although Dr. Kolodny has a work history in public health and addiction psychiatry, he is neither qualified nor Board Certified in pain management — a closely related field that has been profoundly and negatively impacted by his assertions concerning public policy. From his published articles and interviews, it is clear to many readers that he knows or cares little about chronic pain patients and their treatment,” Lawhern’s letter states.

In a series of Tweets earlier this year, Kolodny said patients on “dangerously high doses” of opioids should be tapered to lower doses even if they refuse. He then asked for specific examples of doctors “forcing tapers in a risky fashion.”

Dozens of people responded with examples of patients becoming seriously ill or committing suicide after forced tapering, which Kolodny ignored.   

The letter to Brandeis calls Kolodny “one of the most polarizing and hated figures in medicine” among people in pain.

“In our view and those of many people whom he has harmed, Dr. Kolodny makes no positive contribution to the work or reputation of Brandeis or its research centers.  To the contrary, we believe it is ethically and morally imperative that he be dismissed immediately from the University, before his presence further damages both your reputation and your financial endowments,” the letter states.

The university did not respond to a request for comment on the letter. Neither did Kolodny.

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Brandeis is a well-regarded liberal arts and private research university located near Boston. The Heller School for Social Policy and Management is often ranked as one of the top ten schools in social policy.  Kolodny joined Heller last year as a senior scientist after resigning as chief medical officer at Phoenix House, which runs a chain of addiction treatment centers.

Kolodny and PROP played central roles in developing the 2016 CDC opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Although voluntary and only intended for primary care doctors, the guidelines have been widely adopted as mandatory by insurers, federal agencies and throughout the U.S. healthcare system.

In an online survey of over 3,100 pain patients and healthcare providers on the first anniversary of the guidelines’ release, most said the guidelines were harmful to patients, had not improved the quality of pain care, and failed to reduce opioid abuse and overdoses. Critics also cite anecdotal evidence that the guidelines have contributed to an increase in patient suicides.

Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments

Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments

https://www.federalregister.gov/documents/2017/09/29/2017-20905/opioid-policy-steering-committee-establishment-of-a-public-docket-request-for-comments

 

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, on questions relevant to FDA’s newly established Opioid Policy Steering Committee (OPSC). Opioid addiction and the resulting overdoses and deaths have created a national crisis, which requires action by federal agencies that may in some instances be unprecedented in order to address the situation and attempt to turn the tide on the crisis. As a public health agency Start Printed Page 45598responding to the crisis, FDA seek public input as it considers how its authorities can or should be used to address this crisis. This information will help the Agency understand areas of focus important to the public and identify and address opioid product and policy issues that need clarification. FDA is especially interested in hearing from interested parties in three key areas: What more can FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid-related regulatory decisions; what steps can FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented?

DATES:

Submit either electronic or written comments by December 28, 2017.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 28, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 28, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-5608 for “Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Kathleen Davies, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2310, Silver Spring, MD 20993, 301-796-2205.

SUPPLEMENTARY INFORMATION:

On April 19, 2017, the Secretary of Health and Human Services announced the HHS strategy for fighting the opioid crisis. The five point strategy includes: (1) Improving access to prevention, treatment, and recovery services; (2) targeting availability and distribution of overdose-reversing drugs; (3) strengthening timely public health data and reporting; (4) supporting cutting-edge research; and (5) advancing the practice of pain management. Following that announcement, on May 23, 2017, the Commissioner of Food and Drugs announced his intention to take more forceful steps to combat the opioid crisis. An OPSC was established to explore and develop additional tools or strategies FDA can use to confront this crisis. The OPSC has a broad mandate to consider steps that FDA can take to confront the opioid crisis. FDA is seeking suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, with regard to a number of topics related to three overarching questions: (1) What more can or should FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid-related regulatory decisions; (2) what steps can or should FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and (3) should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented?Start Printed Page 45599

I. Assessing Benefit and Risk in the Opioids Setting

In a July 6, 2017, article in the Journal of the American Medical Association, FDA explained its approach to assessing the benefits and risks of drug products, describing a structured approach that, in the case of opioids, includes extensive additional review of the risks related to the potential misuse and abuse of these products. FDA explained that it is working to incorporate the effects of decisions on public health into its benefit-risk framework in a more quantitative manner that can supplement and enhance the strong qualitative work that the Agency already performs (Ref. 1). In addition, in March 2016, FDA commissioned a study from the National Academies of Sciences, Engineering, and Medicine to outline the state of the science regarding prescription opioid abuse and misuse, the evolving role that opioid analgesics play in pain management, and additional actions FDA should consider to address the opioid crisis with particular emphasis on strengthening its benefit-risk framework for opioids. That report was issued in July (Ref. 2). While FDA considers the report recommendations, we would like to solicit additional feedback that will supplement those recommendations.

Specific questions on which FDA seeks comment relating to this topic are as follows:

1. How should FDA tailor, or otherwise amend, its assessment of benefit and risk in the context of opioid drugs to ensure that the Agency is giving adequate consideration to the risks associated with the labeled indication of these drugs and the risks associated with the potential abuse and misuse of these products?

2. Are there specific public health considerations other than misuse and abuse that FDA should incorporate into its current framework for benefit and risk assessment as a way to reduce the opioid addiction epidemic? That framework includes, but is not limited to, how FDA makes regulatory decisions to approve new opioids, evaluates their use in the postmarket setting, or limits or influences their prescribing through product labeling or other risk management measures.

II. Steps To Promote Proper Prescribing and Dispensing

Proper prescribing and dispensing are critical to successfully reducing opioid misuse and abuse. A 2016 Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain reported that, “[w]hen opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.” (Ref. 3.) And a recent analysis showed that, across six studies of patients who had undergone a variety of surgical procedures, 67 percent to 92 percent of patients reported unused opioid analgesics. Moreover, “[r]ates of safe storage and/or disposal of unused opioids were low,” resulting in an “important reservoir of unused opioids available for nonmedical use . . . .” (Ref. 4). There are clinical situations that may require a supply of opioid analgesics that exceeds current CDC guidelines and FDA wants to make sure that patients have what they need in those cases. But FDA believes there are situations in which patients are prescribed an opioid analgesic when a non-opioid pain treatment would be adequate or, when an opioid product is necessary, treatment with a shorter course of therapy would be more appropriate, and without specific requirements, variance in prescribing habits are likely to persist.

Specific questions on which FDA seeks comment relating to this topic are as follows:

1. Should FDA consider adding a recommended duration of treatment for specific types of patient needs (e.g., for specific types of surgical procedures) to opioid analgesic product labeling? Or, should FDA work with prescriber groups that could, in turn, develop expert guidelines on proper prescribing by indication?

2. If opioid product labeling contained recommended duration of treatment for certain common types of patient needs, how should this information be used by FDA, other state and Federal health agencies, providers, and other intermediaries, such as health plans and pharmacy benefit managers, as the basis for making sure that opioid drug dispensing more appropriately and consistently aligns with the type of patient need for which a prescription is being written?

3. Are there steps FDA should take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice?

4. Are there other steps that FDA should take to help promote the prescribing of treatment durations that are appropriately tailored to a clinical patient need?

III. Requirements for Prescriber Education

Recently, the option of mandating education or training for health care professionals who prescribe opioid medications has been more widely discussed,[1] and some states already are, or are considering, mandating such prescriber education. For example, as of July 1, 2017, health care professionals in New York State who are licensed to prescribe controlled substances must complete, and register their completion of, at least 3 hours of course work or training in pain management, palliative care, and addiction (Ref. 5).

Specific questions on which FDA seeks comment relating to this topic are as follows:

1. Are there circumstances under which FDA should require some form of mandatory education for health care professionals to ensure that prescribing professionals are informed about appropriate prescribing and pain management recommendations, understand how to identify the risk of abuse in individual patients, know how to get patients with a substance use disorder into treatment, and know how to prescribe treatment for—and properly manage—patients with substance use disorders, among other educational goals? Are there other steps FDA could take to educate health care professionals to ensure that prescribing professionals are informed about appropriate prescribing and pain management recommendations?

2. How might FDA operationalize such a requirement if it were to pursue this policy goal? For example, should mandatory education apply to all prescribing health care professionals, or only a subset of prescribing health care professionals? If only a subset, how would FDA construct a framework that focuses mandatory education on only that subset—for example, by requiring mandatory education only for those writing prescriptions for longer durations as opposed to those for very short-term use?

3. What steps should FDA take to make implementing such mandatory education efficient and more feasible? For example, should FDA work collaboratively with state public health agencies, state licensing boards, provider organizations, such as medical specialty societies and health plans, or with other stakeholders, such as Start Printed Page 45600pharmacy benefit managers, to integrate or avoid duplicating their educational programs or requirements? What other steps might FDA consider to make implementation less burdensome and more effective?

IV. Additional Matters for Consideration

1. What other steps should FDA take to operationalize the above described goals?

2. Are there additional policy steps FDA should consider relating to the OPSC that are not identified in this notice?

We invite interested parties to review these questions and submit comments to the docket for the OPSC to consider. In addition, we invite interested parties to submit additional policy considerations or recommendations for actions that FDA could or should undertake to help the Agency better address the opioid addiction crisis.

V. References

1. Gottlieb, Scott and J. Woodcock. “Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic.” Journal of the American Medical Association. 2017;318(5):421-422. Doi:10.1001/jama.2017.9205. Available at http://jamanetwork.com/​journals/​jama/​fullarticle/​2643333. Accessed August 2017.

2. National Academies of Sciences, Engineering, and Medicine. “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (2017), Consensus Study Report.” Richard J. Bonnie, Morgan A. Ford, and Jonathan K. Phillips (eds.). Available at https://www.nap.edu/​catalog/​24781/​pain-management-and-the-opioid-epidemic-balancing-societal-and-individual. Accessed August 2017.

3. Dowell, D., T. M. Haegerich, and R. Chou. “CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016.” Item 6 in “Determining When to Initiate or Continue Opioids for Chronic Pain.” Morbidity and Mortality Weekly Report Recommendations and Reports 2016;65(No. RR-1):1-49. DOI: http://dx.doi.org/​10.15585/​mmwr.rr6501e1. Accessed August 2017.

4. Bicket, M. C., J. J. Long, P. J. Pronovost, et al. “Prescription Opioid Analgesics Commonly Unused After Surgery, A Systematic Review.” JAMA Surgery. Published online August 2, 2017. DOI:10.1001/jamasurg.2017.0831. Available at http://jamanetwork.com/​journals/​jamasurgery/​fullarticle/​2644905. Accessed August 2017.

5. New York State Department of Health, Mandatory Prescriber Education. Available at https://www.health.ny.gov/​professionals/​narcotic/​mandatory_​prescriber_​education/​. Accessed August 2017.

Dated: September 26, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

Could the war on pain pts be considered DOMESTIC TERRORISM ?

Effort to fight opioid abuse is too fragmented

http://www.stltoday.com/opinion/mailbag/effort-to-fight-opioid-abuse-is-too-fragmented/article_04bdd9ef-221b-5e78-bb1f-1f13531102ca.html

It is clear that mass hysteria about the opioid crisis in America has occurred because there is an overwhelming lack of knowledge about the facts and myths surrounding opioid abuse and addiction that delays the implementation of a cohesive plan to address this crisis.

 There is no coordinated effort among interested parties, such as the Centers for Disease Control and Prevention staff, clinical staff, pain management physicians/clinicians, inpatient, outpatient and retail pharmacy staff, administrative and pharmaceutical company staff to do a comprehensive professional literature search, reach consensus about their findings and develop a joint national plan, based on rigorous scientific research, to address this crisis.

As a result, fragmented actions are being implemented by interested parties without a clear understanding of the opioid epidemic and that a joint effort must be taken to resolve this crisis. For example, CVS Health recently issued a news release indicating that it was going to limit opioid prescriptions to seven days, perhaps not fully understanding the ramifications such action would have for patients, especially for those with chronic pain. In addition, their impulsive action begs the question as to whether or not they have appropriate licensure, such as physicians, to limit opioid prescriptions to seven days.

 

It would be a grave injustice and inhumane treatment of patients who have legitimate pain and who really need opioid medications, especially if they are experiencing chronic pain. Without adequate pain medication, these patients may suffer horrific and unrelenting pain for unacceptable, unreasonable and lengthy periods of time, that may ultimately persuade them that death is better than suffering severe pain while living. It would be such a shameful legacy for patient care and for the clinicians who strive to provide high-quality patient care.

CVS Health Refuse to make a Public Apology

Why complaints and petitions are not getting the chronic pain community NO WHERE ?

A ever increasing number of prescribers are becoming EMPLOYEES of large corporations… mostly hospitals.  The reason that many prescriber are becoming employees of these hospitals is because the cost of the “back office” .. where all the billing and other administrative functions are done… is getting more and more costly to keep the hardware and software “current”.

In giving up their private practice, they are subjecting themselves to the whims of the bureaucrats in trying to increase the productivity – and profits – out of the fewest employees.  These prescriber/employees can often be given the choice of following the policies & procedures (P&P) regarding how/when pts are treated.. or they can find themselves becoming unemployed if they don’t follow those P&P’s.

It doesn’t seem to matter that these corporations are attempting to over-write or supersede the state’s medical practice act, which is the basis that gives prescribers their authority to practice medicine. The medical licensing boards seem to have turned a “blind eye” or “deft ear” to what is going on.

Pharmacists are going thru similar troubles…  and both of these boards have professionals sitting on them… most are political appointments… payback for large contributions to election campaigns ? and are employees of the these same corporations, and many wonder why the boards will not call these large corporation “on the carpet” for dictating how these professional practice their respective professions.

So if complaining to a healthcare licensing board and nothing happens… what is a pt to do… Technically, the state’s attorney general is the enforcer of the state’s laws.. and suppose to oversee the various boards to make sure that they do their job.

However, the vast majority of AG’s are suing various entities within legal pharmaceutical medication distribution system over the theoretical opiate crisis… so who believes the various AG’s are concerned about pts that have a valid medical necessity for taking controlled substances ?

The next step on the ladder to get someone to listen to pts being denied care or only receiving “token doses” of their necessary medications… that would be the state legislators… these are the people who passed the laws that are being ignored and not followed.

BUT… these same legislatures are passing laws,rules, regulations that are restricting how many days and how many mgs/day chronic pain pts can be legally prescribed.  So will they care, if chronic pain pts are not getting their necessary medication(s) ?

SO, it would seem that every part of the legislator, executive and judicial branches of our government… are collectively turning a blind eye or deft ear to what is going on..  Really doesn’t make much difference if you are looking at the state or federal level bureaucracies.

IF any of you have noticed, various cities, counties, states are SUING various parts of the pharmaceutical drugs distribution system ( Pharmas, wholesalers, pharmacies) because they are selling a legal product is perceived as the underlying cause of the opiate crisis.  The fact that the drug cartels are generating 100 BILLION/yr in revenue selling ILLEGAL OPIATES/SUBSTANCES… seems to have escaped their notice or they don’t consider them as contributing anything to the opiate crisis.

Has anyone noticed how many hundreds or thousands of petitions have been put up on the web ? AND, how many has produced at least some attention from a bureaucrat/politician that even wants to ask questions to try and find out some of the truth about the opiate crisis that seems to be left out of the majority of the conversation(s) ?

Should the chronic pain community pay attention to what others are doing to interfere/slow down/ stop the opiate crisis ? Hire law firms to sue these corporations for attempting to practice medicine without a license.

Challenge the constitutionality of many laws that our judicial system is using to “fight” the war on drugs

The vast majority of politicians (abt 98%) will get reelected … doesn’t matter what they did do or didn’t do…   How many have sent letters to your elected politician and got a response back that may have – or not have – anything in it that begins to approach the concerns in the pt’s original letter..  Typically, the person gets back a form letter, that may have a few “catch words” that appear in the original letter.

Up to 40% of post-operative pts .. 7 days opiate Rx – NOT ENOUGH !!!

Defining Optimal Opioid Pain Medication Prescription Length Following Surgery

https://www.news-line.com/PH_news28370_enews

A new study led by researchers at the Center for Surgery and Public Health at Brigham and Women’s Hospital analyzed opioid prescription data from the Department of Defense Military Health System Data Repository, identifying more than 200,000 opioid-naïve individuals who had undergone one of eight common surgical procedures between 2006 and 2014 and were subsequently prescribed opioid pain medication. Their findings appear in JAMA Surgery.

Every day, more than 90 Americans die after overdosing on opioids, according to the National Institute on Drug Abuse. Misuse of and addiction to opioids has become a public health crisis with more than 2 million Americans suffering from substance abuse issues related to prescription opioid pain medication. While over-prescription of pain medications has been implicated as a driver of this growing opioid epidemic, few guidelines exist on how to appropriately prescribe opioid pain medication following surgery with the goal of balancing pain with risk of addiction. There have been several recent governmental efforts to address the rise in opioid pain medication prescriptions, which quadrupled between 1999 and 2012. In Mass. and New York, legislation has limited initial prescription lengths to less than seven days and driven the development of drug monitoring programs.

To determine optimal opioid pain medical prescribing practices, particularly in the setting of postoperative, outpatient pain management, researchers from the CSPH at BWH investigated opioid pain medical prescription patterns following common surgical procedures. The team sought to identify the appropriateness of the prescription as indicated by the rate of prescription refills and to develop recommendations.

Using a nationally representative sample of people who were opiate naïve undergoing common procedures, researchers found that median prescription length for the first-time prescriptions was four to seven days, and that the number of people who required a refill of their opiate prescription varied from 11.3% to 39.3% depending on the type of procedure performed. The duration of the prescription also varied depending on the category of procedure, from nine days for general surgery procedures to 15 days for musculoskeletal procedures.

“While seven days may be more than adequate for many patients undergoing common general surgery and gynecological procedures, prescription length limits may need to be extended to 10 days, recognizing that as many as 40% of patients may still require a refill at a seven-day limit for pain management, particularly following many orthopedic and neurosurgical procedures,” said first author Rebecca Scully, MD, MPH, a resident in the Department of Surgery at BWH who works in the CSPH.

Researchers used data from the Military Health System Data Repository, which tracks care delivered to active, disabled and retired members of the US armed forces and their dependents. Researchers identified 215,140 individuals aged 18-64 who had undergone one of eight common surgical procedures (cholecystectomy, appendectomy, inguinal hernia repair, ACL reconstruction, rotator cuff tear repair, discectomy, mastectomy and hysterectomy) between 2006 and 2014 and had filled at least one opioid pain medication prescription in the 14 days following the procedure. The study excluded individuals with a prior diagnosis of chronic pain, substance dependence or an opioid prescription within six months preceding the index procedure. General surgery procedures were performed on 122,435 individuals, while 47,998 underwent musculoskeletal procedures, and 44,707 received a mastectomy or hysterectomy.

Using a mathematical model, researchers determined that the optimal length of opiate prescription was four to nine days for general surgery procedures, four to 13 days for women’s health procedures, and six to 15 days for musculoskeletal procedures.

“We recognize that the opiate crisis is being addressed on many social, legislative, and policy levels,” said senior author Louis Nguyen, MD, MBA, MPH. “We hope our paper provides a quantitative analysis of current prescribing patterns and sheds light on the optimal prescription in patients undergoing surgical procedures.”

CVS’s Transparent Opioid PR Stunt

CVS’s Transparent Opioid PR Stunt

https://www.acsh.org/news/2017/09/28/cvss-transparent-opioid-pr-stunt-11880

CVS has taken it upon itself to enact rules that allow their pharmacists to ignore a physician’s prescription by changing the number of pills, the daily maximum dose, and even the form of the drug itself. And the company’s new policy is based on a decidedly faulty premise, which I will describe below. What the company just did is bad news for both physicians and their patients. Let’s try to set them straight.

Since I am nothing if not helpful, I have taken the liberty of writing up a memo for the company to distribute to its pharmacists. Of course, CVS is free to tinker with the phraseology if they so choose. Corporate-speak is not one of my strengths. Here it is:

MEMO TO ALL CVS MANAGERS (RE: DISPENSING PRESCRIBED PAIN DRUGS, NEW PROTOCOL)

  1. In the morning, open the store.
  2. Have your pharmacists go behind the counter and do their jobs.
  3. Not the jobs of the FDA, DEA, CDC or the KGB.
  4. Tell them to dispense the f######ing pills that the doctor ordered. It is the doctor’s call, not theirs.
  5. Close the store.

I see CVS’ recent move to place restrictions on pain medication as little but a calculated attempt to look like heroes in a crisis. This just doesn’t smell right, only self-serving. And pardon me if I’m not impressed by the company’s $2 million contributed to opioid abuse treatment charities. It may appear to be altruistic, but it’s peanuts to CVS since it represents a whopping 0.02% of their annual profits and 0.001% of its sales ($177 billion in 2016).

I can almost picture all the CVS execs on the golf course patting themselves on the back for scoring big PR points with the public. Perhaps a few of them are even delusional or uninformed enough actually to believe that they just did something useful. But I doubt it. This has “disingenuous” written all over it.

And, if I’m a doctor, I’m gonna be mighty unhappy if a pharmacy doesn’t do what I tell them (not ask them) to do. And plenty of doctors around the country are not terribly happy about it either. I spoke with six. All were unhappy.

One is Dr. Arthur Kennish, a New York cardiologist who has been hassled, just like many other physicians for having the unmitigated gall to treat patients the way they choose. 

“CVS has some nerve. The use of opioids, or any other drug, really, is up to the doctor and his or her patients, not a pharmacist. This is a terrible precedent, which will drive an even bigger wedge between physicians and patients. It’s already too big”

Arthur Kennish, M.D. September 26, 2017

And Dr. Thomas Kline, who is a geriatric specialist in North Carolina, and active in fighting what he calls “a war on pain patients” was even blunter:

“Limiting prescriptions discriminates against 9 million people with painful diseases who will never addict nonetheless suffering inconvenience and humiliation to assuage the comfort zones of a long history of abstinence reformers, coming once again to the polemic footlights.”

Thomas Kline, M.D. September 27, 2017

(See below for quotes from the American Council physicians’ take on this matter)

So, what is CVS doing that has pain patents angry and terrified? Let’s examine the three worst ideas.

  1. Limiting to seven days the supply of opioids dispensed for certain acute prescriptions.
  • Let’s say that an orthopedic surgeon knows that an operation will cause a patient two weeks of bad pain. At which point they can switch to something like Advil. Yet, a bunch of executives decided that the store will only give a new patient a one-week supply. Do they know better than the surgeon what is best for his patient? 

     2. Limiting the daily dosage of opioids dispensed based on the strength of the opioid.

  • This one is even worse. At least in the first case, despite wasting the doctor’s time by making him write another script, and having to make two trips instead of one, at least the patient will get what is needed. But having a pharmacist dictating a maximum daily dose is really crossing the line. It is none of their damn business. Scientifically, it’s even worse. All people react differently to opioids. For example, some are 15-times better at metabolizing the drug than others. So an arbitrary maximum dose may work well for one person but be inadequate for another. Do you guys even know this?

     3. Requiring the use of immediate-release formulations of opioids before extended-release opioids are dispensed.

  • This is really dumb. Depending on the individual situation, there can be advantages for either immediate-release pills and time-release. A regular opioid pill will bring faster relief than an extended-release version, but wear off much sooner. Time-release medications result in a more consistent concentration of the drug in the blood; fewer ups and downs, as illustrated in Figure 1, but  they don’t dull the pain as quickly. How exactly has CVS figured out that short-acting opioids are better than long-acting ones for new patients? 

 

Figure 1. A comparison of blood levels of short-and-long acting pain medication.

But the CVS policy raises larger and more far-reaching concerns. Who is in charge of our own health? Why are laws being made that tell us how much medicine we can take? And, since when do pharmacists overrule physician decisions?

Unless there is an obvious prescribing error or a serious drug-drug interaction or any other pharmacological issue, they don’t (1). Until now. And you don’t want them to. It takes away a little more of your control of your own health, something that has been trickling away for years.

Why is CVS doing this now? I’ll speculate. During a crisis, it is always a good idea to hop on the “Let’s find someone to blame” bandwagon. It works splendidly, something that politicians and bureaucrats know quite well. Doctors and drug companies have taken the brunt of the blame (the FDA to a lesser extent) because they are easy and convenient targets. Yes, it’s true. There were some unscrupulous doctors who ran pill mills and did much damage. Purdue Pharma, the makers of OxyContin got a $685 million spanking for promoting an exaggerated safety profile of the drug. And there are some other companies that don’t look so hot right now either. But blame is merely a distraction. Hundreds of people are dying every day and it’s not from the pills. There’s your crisis.

It is always easier to run with the crowd than swim against it, no matter which way it’s going. It did not take long for politicians to buy a one-way ticket in the wrong direction: “Sure, everyone knows that these damn pills are killing everyone, so let’s stop them,” they tell the public.  In what almost seems to be a tough guy contest, states are blindly following the CDC’s 2016 very flawed “advice” and passing some awful laws. If Kentucky enacts tough laws, then Florida better get tougher, as evidenced by Gov. Rick Scott’s proposed law that would allow a three-day maximum prescription unless strict conditions are met. What’s next? Mandatory bamboo under the fingernails tolerance workshops? If there’s a problem someone has to do something about it, right? If it’s the wrong thing, what are you gonna do? At least it sounded good.

But the worst problem with these already-flawed policies and laws is that they are based on the premise that pain patients got hooked on drugs and are now dying from fentanyl. This is false. There is ample evidence in the literature that very few pain patients become addicts; estimates range from .05-10%. (See: Heads In The Sand — The Real Cause Of Today’s Opioid Deaths.“) So the ill-conceived laws that are popping up like weeds and policies that CVS initiated are solving the wrong problem. In (supposedly) trying to protect pain patients from themselves, these policies do nothing but punish them with pain, terror, and despair while at the same time tying the hands of physicians who prescribed opioids wisely and responsibly. 

If CVS doesn’t know all of this, they should. If CVS does know this as well and doesn’t much care, you have to give them credit. Nicely played.

Notes:

(1) In these cases, the pharmacist will consult the physician and offer advice if necessary. They are not overruling anyone. 

(2) Comments from the American Council’s physicians:

“I have an OB/Gyn colleague who prescribed antidepressants to her patient. The pharmacist refused to fill it saying not within the scope of her practice. The pharmacist’s role is not to be questioning a physician’s clinical skill or clinical decision-making. Leave doctoring to doctors.” Dr. Lila Abassi

“Pharmacists, as part of their licensure responsibility, should check prescriptions for accuracy in dosage and can question the use of medications especially in settings of allergies or cross-reactivity with other medications on a patient’s med list. I do not believe that a pharmacist can or should refuse to fill a prescription based on quantities to be dispensed without speaking directly to the prescribing physician.” Dr. Charles Dinerstein

“For pharmacists to be able to override a physician’s order, given the limited scope of their training and that they are not privy to a patient’s entire clinical picture (or medical history), could put a patient at greater risk. As is current practice, discussions with the treating physician to clarify concerns are always welcomed and encouraged before a pharmacist fills a prescription. But, not mandates–and one not in the best interest of the patient is simply unacceptable.”  Dr. Jamie Wells

It would seem that CVS is trying to “ride the wave” of public sentiment…  Abt one + year ago CVS eliminated all the sales of tobacco products… given that this is a LOW GROSS PROFIT MARGIN product and at risk of high pilferage … and was not a customer self-service item… so it is questionable if this category of product even produced a NET PROFIT, so… was this move toward a “more healthy image” for CVS or them “dumping” a unprofitable category and put a spin on it as being giving CVS a more of a “healthcare provider” image and not the convenient/variety store with a prescription dept in the back…that is reality.

CVS’ front end sales have been sliding for several years…  http://marketrealist.com/2015/08/can-cvs-front-store-business-overcome-key-headwinds/

They are adding more “healthy snack product” to their inventory… placing them in the high visibility space that was previously occupied by what is now deemed “unhealthy snack foods” and moved those “unhealthy products” to less visible shelf space.

Even though use/abuse of tobacco products directly/indirectly contributes to abt 450,000/yr death, Many CVS stores continue to sell Alcohol products who use/abuse contributes to some 100,000/yr deaths…

Over the last decade, CVS has been fined tens to hundreds of millions of dollars by the DEA for what the DEA determined as “contributing to opiate diversion and addiction”.  Two of their stores in Sanford, FL were “ground zero” when the pill mill problem in FL erupted earlier in this decade.

Now CVS and its PBM subsidiary (Caremark/Silver Scripts) are jumping on the current  and revised “war on drugs” bandwagon ?  Will this denial of care to those with chronic pain and other subjective diseases just an attempt by CVS to get them in DEA’s “good graces” … since they are now a full fledged “partner” in fighting the war on drugs.

Which could means fewer fines for CVS and larger bottom line profits for CVS… if many pts end up suffering from untreated pain and/or ends up committing suicide because of the denial of care that they experience at the hands of CVS Health… just COLLATERAL DAMAGE so that CVS can make more profits ?

 

The War on Drugs is based on FAKE SCIENCE, warns lab science director who says labs routinely engage in “science crimes” against innocents

https://youtu.be/RqJ7kLGjU9s

The War on Drugs is based on FAKE SCIENCE, warns lab science director who says labs routinely engage in “science crimes” against innocents

http://www.naturalnews.com/2017-04-20-the-war-on-drugs-is-based-on-fake-science-warns-lab-science-director.html

(Natural News) The “War on Drugs” is a grand science hoax based on faked laboratory analyses conducted by lab science con artists working for government.

That’s not hyperbole, by the way: It’s a matter-of-fact description of exactly how the drug war is being waged in America, thanks to lab science criminals like Annie Dookhan, who pleaded guilty to systematically faking lab science that convicted over 24,000 people on charges of drug possession. (See the video below.)

Now, over 20,000 of those convictions are about to be thrown out because Dookhan deliberately faked the science.

“About 21,000 drug convictions are set to be thrown out in Massachusetts after a chemist admitted tampering with evidence and falsifying results,” reports Sky News. “It could be the single largest dismissal of criminal convictions in US history.”

Knowingly falsified drug test results to convict innocent people in the interests of government prosecutors

Natural News covered all this five years ago when it was first learned that Dookhan falsified lab science evidence in as many as 34,000 cases. As this Natural News story documented:

Dookhan has admitted she improperly removed evidence from storage, forged the signatures of colleagues and did not conduct proper tests on drugs for “two or three years,” according to a copy of a State Police report obtained by the Boston Globe newspaper recently.

It took five years for the courts to finally order prosecutors to drop the 24,000+ drug convictions, all while innocent people were left to rot behind bars while the “justice system” kept them all imprisoned under false pretenses. As Natural News reported earlier this year:

Recently, the state’s highest court ordered prosecutors to drop a significant portion of the more than 24,000 drug convictions to resolve a scandal – where thousands of people were wrongfully convicted on drug charges in Massachusetts – that has plagued the legal system since 2012.

Annie Dookhan is just one of thousands of lab scientists across America who are faking drug tests every day to falsely convict innocent people

As the lab science director of an internationally accredited laboratory — CWC Labs — I can authoritatively tell you two astonishing things that have become clear to me over the last three years of interacting with the lab science community:

#1) Nearly all the field drug test kits produce false positives for a wide range of substances, from over-the-counter medicines to chocolate bars. A narcotics detective can easily produce a “hit” for almost any suspected substance by coaxing a “positive” from the drug test kits. These kits are scientifically worthless and meaningless, yet the courts continue to treat them as some sort of gold standard proof of evidence of possession. Many of these kits are read by a totally subjective opinion of the color of the resulting liquid, for example. “Color” is completely subjective, and it varies wildly based on ambient light conditions, the mood of the law enforcement officer, and the color pigmentation of the original sample. The human eye gauging a color is not science… it’s total hokum.

#2) Most science labs have no real interest in analytical accuracy. I know this because people in the industry keeps telling me I’m totally obsessed with extreme accuracy, and I’m finding that this dedication is apparently unique to my own lab. To my astonishment, I’ve come to learn that typical drug labs have huge “error budgets” for analytical accuracy, and many of those labs have no idea what their real error rates might be through the entire process of sample prep, analyte extraction, instrument analysis and reporting.

Some labs don’t even know the real LoD or LoQ (Limit of Detection / Quantitation) of the substances they’re looking for (analytes) in the instruments they’re using for testing, and even worse, many labs operate with unclean analytical practices that can result in significant “carryover” which can contaminate one sample with the residues of the previous sample. In other words, there are without question people sitting in prison right now whose only crime was being the next sample in the sequence after a high-concentration sample was run before theirs.

Right now, I could walk into almost any crime lab in America and find huge faults, errors and even fraud in their analytical methods, lack of proper sample handling, lack of technician training, bad statistics, bad reference curves, bad instrument calibration and so on. I’m convinced that nearly every government-promoted crime lab in America is engaged in its own “science crimes” that are designed to deliberately produce false positives in order to continue the tyrannical, idiotic “war on drugs” and keep themselves in business, collecting government money for producing totally junk science.

Annie Dookhan is just the tip of the iceberg on all this. Watch my mini-documentary below to learn the shocking truth about fake lab science pushed by governments all across America. Share this video everywhere… there are innocent people behind bars right now who were convicted by all this fake science.

Governor Jerry Brown Ties To CVS Pharmacy Under Grand Jury Investigation

Governor Jerry Brown is accused of giving CVS Pharmacies access to top secret confidential Government files used to open thousands of Minute Clinics and run unsuspecting doctors out of business by telling patients their doctors are criminals. BAD NEWS MEDIA DISCLAIMER: The content of this video does not reflect the opinion of Bad News Channel. The video provided is the property of a 3rd party and all rights are reserved. Please Support: www.americanpaininstitute.com and Please Donate to Our March on Washington DC: https://www.gofundme.com/sickle-cell-… Please Sing Petition For Police Review Committee of Medical Boards at Change.org: https://www.change.org/p/medical-boar… 2018 PAIN PATIENTS ADVOCACY WEEK April 23 to 30 Click Here: http://www.painpatientscoalition.com/… Video Testimony is the property of 3rd party source. Please contact Mr. Billy Z. Earley directly at bze123.fccf@gmail.com if you have any questions. Billy Z. Earley Physician Assistant, Healthcare Medical Advocate, World Sickle Cell Federation Advocate, National Advisory Board Black Doctors Matter, National Advisory Board American Pain Institute, Coalition for the Humane Treatment of Sickle Cell.