Drug Legalization: Why I Believe it Will Never Happen

Lately, there has been much grief about the “opioid crisis”. As a pharmacist, I’m pretty much on the front lines in this battle. In some respects, I believe it’s over-blown and I’ve actually seen some statistics which shows that the peak of opioid prescribing was in 2013 and it’s been trending down since then. Regardless, the tightening of Federal and State laws as well as corporate regulations make it very hard to practice my profession in a truly compassionate manner.

Hence, I continue to buy lottery tickets.

Regardless, there is a problem. I’ll pull some rank here and try to explain things as best I can. The United States has a population of 330 million people. In other words, we make up 5 percent of the world’s population. Yet we consume 85 percent of the world’s legally prescribed opiates. That’s a problem a grant you.

In addition, the range of opioids available in the United States is staggering: tramadol, pentazocine, codeine, morphine, hydromorphone, oxymorphone and so on. In other countries (such as Turkey) there are only two options available: tramadol (for mild to moderate pain) and morphine (for severe pain). That’s it. I guess most people just “buck it up” and take an aspirin or a Tylenol for anything less than moderate pain.

There is of course a spiritual dimension to all this. Not in the sense that those who find themselves in the grip of addiction are sinners but that American consumerism has seduced our population in ways that make all sorts of addictions inevitable. Drugs for this, credit cards for that. One isn’t “somebody” unless one is wearing the right dress-shirt or the latest footwear. In the inner city, black youths will literally kill each other for the latest pair of Air Jordans (which are made in China by serfs toiling in sweatshops).

The Church Fathers call these things “the passions” and we are called to refrain from them. But when our government encourages so much of our pathology then one has to wonder what game is afoot. Consider: our agricultural policies distort farming and mandate subsidies that encourage the sale of unwholesome foods. This has resulted in a world-wide obesity epidemic the end-result of which is diabetes, the feminization of men, increased cancers in general and heart disease.

Regardless, there is (as I said earlier) a problem. However before we can discuss this problem, we must discuss the whys and wherefores of drug legalization and decriminalization. That is to say why or why not the harder drugs can (or cannot) be legalized.

I’ll cut right tot he chase and give you six reasons why I don’t believe it’s possible to legalize illegal drugs (such as marijuana, peyote, mescaline, heroin, etc.). Below is an overview which I will explore in more detail in the video below:

1. Money laundering. It would put an end to money laundering and thereby possibly collapse the international banking system.

2. It’s a honey-pot. That means it attracts the urban underclass and directs their creative energies in a negative fashion and keeps it confined to the urban ghetto. As to why the Oligarchy does this one can only guess. Perhaps the dysgenic effects of multi-generation welfare subsidies have taken their toll and the natural creative and entrepeneurial spirit can only be exercised in criminal enterprises.

3. Private prisons. The United States has 5 percent of the world’s population but 25 percent of the world’s prisons. That’s an astonishing number. Beginning in the last century, the State governments turned to private enterprise to warehouse the growing number of people that needed to be incarcerated.

4. Civil asset forfeiture. Governments, like people in general, like to acquire money as easily as possible with as little effort as possible. The bar for proving criminality in drug busts is fairly low. When the allure of a moral crusade is added in the mix, then seizing assets becomes all the more appealing.

5. Hiding assets. Like the bootleggers of old, drug lords have a vested interest in maximizing their profits. The illegality of drugs does this by driving up demand while driving down supply. For many poor whites in the rural and exurban areas, the sale of methamphetamine is not only lucrative, it’s profits are nearly impossible to see. Ex-wives are hard-pressed to exercise their claims to their assets if they’re “non-existent”.

6. Prudential reasons. Nobody wants to see bums passed out on their lawn. Opium dens are not a pretty sight. The attitude known as NIMBY (Not In My Back Yard) is a powerful one and can’t be minimized.

Anyway, Yours Truly will flesh out these reasons in more detail below.

[P.S. Mention just came to me that Nick Katich, a life-long Orthodox Christian just fell asleep in the Lord the other day. Nick was an activist who loved Christ’s Church and wanted what was best for Her. Although we didn’t always agree, his commentary on this blog was always thoughtful and heartfelt. I ask all of us to remember him and his family in your prayers. He will be missed.]


  1. George Michalopulos says

    At 9’15” I misstated a factoid: we have 1/4 of the world’s prison population. In other words, one out of four prisoners on earth at any one time are imprisoned in the United States.

  2. Memory Eternal to Nick Katich.

    The font of the above ailments is feminism, not just consumerism. Mommy’s answer to bad boys, which she created, is to give them a time out. Were there a Daddy on site, there would not be nearly as many bad boys misbehaving but rather grown men focusing their energies on being men rather than bad boys.

    But Daddy has been banished. Tragic, really.

  3. Addictions are where anyone goes to rest from a problem at hand, be it temporary or on-going. I follow food addiction so see this first-hand. George, what you wrote about this being spiritual is first and foremost, 100%. This society would not, if it had to, ever call it that, but it is. This puts you in the leagues of Warriors for Christ for calling it out; that you even say it. More like, Confessor of Christ. Thank you.
    And to think I marveled many years ago at the Sackler Gallery of Asian Art collections, not knowing then the magnitude of horror of where the funds for it came from. Time always tells.

  4. Christopher says

    Important subject George. Most “law abiding” citizens simply do not recognize how their own or the States interests reinforce the status quo. The moral tragedy that is our prison system and “the war on drugs” is hard to overstate. Interestingly, we tried Prohibition and it is so widely accepted that it was a failure with many “unintended consequences”, that we teach its history to school children. Yet, prohibition 2.0 (i.e. the “war on drugs”) is taken an obvious moral good.

  5. I’m going to sound like the SNL church lady character, but George you forgot one big reason. Maybe the most important, and prevalent. Satan! Imagine what a tool the evil one, and his demons have, not only on the ground level with the individual user, but every level of society. Kings to slaves!

    Yes all of us. Monetarily, and how we live our lives protecting our possessions, and loved ones. But, most importantly, spiritually we have become, numbed, dumbed, distracted, and distorted from all that is good, which keeps us farther away from God. Satan loves the control illegal drugs give him, power, money, control over one, one powerful person or small groups of powerful individuals helping him, destroy millions of souls. Illegal drugs literally networks to all, everywhere, and everywhere is also Satan and his demons to influence so many. This also includes legal drugs not used properly, and also illegally abused. Point is, so long as illegal drugs remain illegal, Satan and his demons control all levels of society, from the homeless junkie all the way to our President, who doesn’t even drink. With drugs legalized, Satan’s reach can only go so far, he likes the way things are, and will do all he can to keep it that way.

    “Be sober minded and alert. Your adversary the devil prowls around like a roaring lion, seeking someone to devour.” (1 Peter 5:8)

  6. Gail Sheppard says

    As an aside, the deaths attributed to opioid use include street drugs like heroin laced with fentanyl. Street drugs are much cheaper so if you’re going to stop the epidemic, it seems to me you would start there. But no! It is BELIEVED that illicit use of opiates is due to the experience one has with a prescribed opioid, but I am not aware of one study that legitimately supports this. I suspect this war on opiates is motivated by soon to be introduced drug(s) that purportedly have pain killing properties but do not trigger the addictive part of the brain. (But you all know how I embrace every single conspiracy theory. . . joke.) These drugs won’t be perceived as being strong enough for chronic pain unless tolerance is reduced, which the CDC has effectively done with a directive they published last April. It is now extremely difficult to be prescribed opiates in higher doses, even in the emergency room. Tramadol is being used and it is a poor substitute for severe pain which some people experience daily.

    There are some interesting books that have been published on the subject. One is called, “Dreamland,” by Sam Quinones. In the front of the book is a chapter entitled, “Dr. Jack’s Letter.” In the late 70s, Hershel Jick who worked for Boston University created a database of all the drugs prescribed in hospitals and their effects. The program was called the Boston Collaborative Drug Surveillance Program. He wrote a paragraph of his findings: “Of the almost 12K patients treated with opiates while in the hospital before 1979, and whose records were in the Boston database, only 4 had grown addicted.” That’s .03%. (See New England Journal of Medicine January 10, 1980.)

    There have been other studies that show similar results, although the CDC refuses to acknowledge them, while freely admitting they have NO studies that rigorously assess the long-term benefits of opioid use for chronic pain. Those who use medication for chronic pain represent 3%–4% of the adult U.S. population and they are, sadly, those who are hit hardest by the CDC’s meddling. It’s worth remembering that the mucky-mucks at the CDC are the same people who insist our children receive 4 vaccines for polio, even though polio was irradiated from this country back in the 70s. There are presently only 37 cases of polio IN THE WORLD (on the other side of the planet) and these patients are no longer contagious, as you can only get it from someone a week or two before symptoms begin or by ingesting the feces of an infected person a few weeks after. How likely is this? Seriously. Few people realize that of the people who ARE infected, only 1% will get symptoms. We probably all got it in the 50s but didn’t know it. Gone are the days of the polio virus thriving in our drinking water, contaminated by antiquated sanitation systems that have since been replaced, thank God. The final vaccine in the polio series is a booster that is believed to last a lifetime, but they don’t know! They do know that Big Pharma gets paid every time your kid gets vaccinated against a disease that for all practical purposes doesn’t exist. None of us question this practice because it comes from the CDC: The same people who have sounded the alarm on the evils of prescribed opiates because it makes so much more sense (being facetious) to get them on the street where they’re cheaper and stronger.


    • M. Stankovich says

      So now if you would, Gail, please cite the data “Dr. Jack” provided with his historic letter to the NEJM, indicating that his was a “scientific examination” of those patients who “experienced no iatrogenic addictions or significant consequences” to opiates prescribed in the metropolitan area of Boston in the period of his “examination.” Since you obviously didn’t read the narrative as was published in the same New England Journal of Medicine last Fall, allow me to summarize the result of a two-year investigation by Canadian researchers into this “study.” What they found was this man’s pure conjecture and generalization based on his own and his single practice’s anecdote – and that would be himself and one other physician. It was not a research article submitted to the NEJM – arguably the most prestigious and respected medical journal in the world – but a letter to the uncorroborated, uninvestigated Correspondance section of the journal, and from there – without any evidence, absolutely none, to support its conclusion whatsoever – made its way into the canon of medical practice in the US. And so much so that the Canadian researchers found it last quoted and “cited” in a reputable cancer treatment journal in 2014, continuing to scold physicians who “under-medicate patients which needlessly causes undo pain & suffering.” If you are suggesting there are “other” supporting studies – and the CDC is purposely negligent or manipulative- I for, one, am certainly not amused, as one who twice a week walks in to deliver a lecture to a gathering of individual who draw air by the merciful intervention of God and a little Narcan. By all means cite them, and soon. Otherwise, I find this entire post especially irresponsible. This has become a c-r-a-z-y-t-o-w-n of conspiracy. And for heaven’s sake, all the time invested in crank theories, you could have taken a real course in epidemiology if you really wanted to know who’s buying dope on the streets… Madonna Mia!

      • M. Stankovich says

        An addendum: This is what I have described as was published by the Canadian researchers in the New England Journal of Medicine N Engl J Med 2017; 376:2194-2195:

        A 1980 Letter on the Risk of Opioid Addiction

        To the Editor:

        The prescribing of strong opioids such as oxycodone has increased dramatically in the United States and Canada over the past two decades.[1] From 1999 through 2015, more than 183,000 deaths from prescription opioids were reported in the United States, [2] and millions of Americans are now addicted to opioids. The crisis arose in part because physicians were told that the risk of addiction was low when opioids were prescribed for chronic pain. A one-paragraph letter that was published in the Journal in 1983 was widely invoked in support of this claim, even though no evidence was provided by the correspondents (see Section 1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org).

        We performed a bibliometric analysis of this correspondence from its publication until March 30, 2017. For each citation, two reviewers independently evaluated the portrayal of the article’s conclusions, using an adaptation of an established taxonomy of citation behavior [4] along with other aspects of generalizability. For context, we also ascertained the number of citations of other stand-alone letters that were published in nine contemporaneous issues of the Journal (in the index issue and in the four issues that preceded and followed it).

        We identified 608 citations of the index publication and noted a sizable increase after the introduction of OxyContin (a long-acting formulation of oxycodone) in 1995. Of the articles that included a reference to the 1980 letter, the authors of 439 (72.2%) cited it as evidence that addiction was rare in patients treated with opioids. Of the 608 articles, the authors of 491 articles (80.8%) did not note that the patients who were described in the letter were hospitalized at the time they received the prescription, whereas some authors grossly misrepresented the conclusions of the letter . Of note, affirmational citations have become much less common in recent years. In contrast to the 1980 correspondence, 11 stand-alone letters that were published contemporaneously by the Journal were cited a median of 11 times.

        In conclusion, we found that a five-sentence letter published in the Journal in 1980 was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy. We believe that this citation pattern contributed to the North American opioid crisis by helping to shape a narrative that allayed prescribers’ concerns about the risk of addiction associated with long-term opioid therapy. In 2007, the manufacturer of OxyContin and three senior executives pleaded guilty to federal criminal charges that they misled regulators, doctors, and patients about the risk of addiction associated with the drug.[5] Our findings highlight the potential consequences of inaccurate citation and underscore the need for diligence when citing previously published studies.

        Pamela T.M. Leung, B.Sc. Pharm., et al.
        University of Toronto, Toronto, ON, Canada

        1. Ballantyne JC. Opioid therapy in chronic pain. Phys Med Rehabil Clin N Am 2015;26:201-218

        2. Prescription opioid overdose data. Atlanta: Centers for Disease Control and Prevention, 2016

        3. Porter J, Jick H. Addiction rare in patients treated with narcotics. N Engl J Med 1980;302:123-123

        4. Bornmann L, Daniel H. What do citation counts measure? A review of studies on citing behavior. J Doc 2008;64:45-80

        5. Meier B. In guilty plea, OxyContin maker to pay $600 million. New York Times. May 10, 2007 (http://www.nytimes.com/2007/05/10/business/11drug-web.html).

        • Gail Sheppard says


          I think I characterized what Jick submitted accurately, citing MY source, which was a book! Here is the paragraph he submitted to the NEJM: http://www.nejm.org/doi/pdf/10.1056/NEJM198001103020221

          Based on your post, it appears as if Jick’s critics were concerned that it shaped a narrative to which they did not ascribe. They did not, however, directly dispute his findings.

          Let’s look more closely at the causes for the overdose deaths from 2010 to 2015, as that’s what the CDC was looking at when they came out with their directive recommending the use of OTC medications, as opposed to opiates, for anything other than terminal cancer:

          1. Deaths from drug overdose involving heroin TRIPLED from 8% in 2010 to 25% in 2015 (Figure 5).

          2. For drug overdose deaths involving natural and semisynthetic opioid analgesics, which include drugs such as oxycodone and hydrocodone, the percentage DECREASED from 29% in 2010 to 24% in 2015.

          3. The percentage of drug overdose deaths involving methadone also DECREASED, from 12% in 2010 to 6% in 2015.

          4. For drug overdose deaths involving synthetic opioids other than methadone, which included drugs such as fentanyl (heroin is often laced with fentanyl) and tramadol (which the CDC recommends in lieu of other opiates), the percentage INCREASED from 8% in 2010 to 18% in 2015.

          5. The percentage of drug overdose deaths involving cocaine INCREASED from 11% in 2010 to 13% in 2015.

          6. Drug overdose deaths involving psychostimulants with abuse potential, which include drugs such as methamphetamine, INCREASED from 5% in 2010 to 11% in 2015.


          So, drug deaths from prescribed opiates were DECREASING when the CDC felt the need to step in and tell doctors how to practice medicine, ignoring other overdose related deaths that were increasing. Explain to me how this makes sense.

          • M. Stankovich says

            As I am very familiar with what Jick presented to the NEJM in his correspondence, and for the second time I will ask you, what evidence did he provide to support his contention? And the answer is none whatsoever. Jick authored and/or co-authored 368 scientific papers in his career, but on this occasion, he chose to write a write a letter and supported his opinion with nothing.

            Secondly, I object to you drawing any further conclusions from his “critics” when you have not even read the Canadian study, but you are suggesting “They did not, however, directly dispute his findings?” WAT! That is the entire point of their research! In the full study – as they briefly note in the accompanying letter I posted – they identified 608 published occasions – one more outrageous than the next – where an author specifically cited Jick as scientific authority to utilize narcotic preparations as safe and effective without the fear of addiction in patients with what we now refer to as “acute pain syndrome.” Gail, did you miss the part about about massive fines and criminal proceedings against pharmaceutical companies for purposely misleading and outright deception of the dangers in order to boost sales? It was a criminal enterprise as well.

            And finally, you are so seemingly “shocked” by 5-year trends in addiction and subsequent over-dosage data – “Explain to me how this makes sense” – as to miss the truly shocking longitudinal consequences of Jick’s impact from January, 1980 until 2017. 5-yr trends in the epidemiological profile of drug use, abuse, marketing trends, and so on are common. Many would say that if the CDC – as the assigned monitor of epidemiological patterns, be they contagion or over-dosage – had stepped in 10-years earlier, countless lives might have been saved, making your comparison with polio a cheap shot, a very cold analogy. I repeat myself that you and Mr. Michalopulos are not qualified to speak to these matters reliably. The whole point of the Canadian study was to demonstrate the danger of the promulgation of anecdote and conjecture, and you answer with more of the same, in a matter of five lines.

          • M. Stankovich. says

            The Morbidity & Mortality Weekly Report of the CDC for 03/28/18 corroborates a significant point Gail made here and I stand corrected.

            The CDC noted that there were 63,632 deaths in the US related to drug overdoses, 66.4% of which were related to opiates. What was remarkable about the 2015-2016 statistics was that the rate of deaths from synthetic opiates not methadone rose to 27.9%, double the rate fro 2014-2015; prescription opiates overdoses rose 10.6% and heroin overdoses rose 19.5%, and cocaine overdoses dramatically rose by 52.4% and psychostimulants (e.g. amphetamine and derivatives) by 33..3%. The answer to Gail’s question regarding cocaine & stimulants, “What’s up with that?” is strongly suspected to be an infiltration of some form of an illicit fentanyl in the cut (interestingly for which any chemist can now download free software to identify fentanyl analogs in mass spectography. The rates of the presence of multiple drugs in overdose deaths rose as well, with the predominate 2nd drug and beyond being a fentanyl analog, benzodiazepine, and/or cocaine. The empidemiological data of age adjusted rates of drug overdose deaths for 2015-2016 were natural opiates not methadone, 13.5 per 100,00 people; synthetic opiates other than methadone, 6.2 per 100,000; prescription opiates, 4-5 per 100,000; heroin, 4.2 per 100,000; cocaine, 3.2 per 100,000; and psychostimulants with abuse potential at 2.5 per 100,000.

            There most certainly is an opiate epidemic, for which the CDC recommends “naloxone availability, safe prescribing practices, harm-reduction practices, linkage into treatment, and more collaboration between public health and public safety agencies.” In my estimation, this a prudent, rational, conservative, and life-saving response.

      • George Michalopulos says

        Dr S, two points:

        1. This blog does not traffic in “crazytown” conspiracies. Gail almost always backs up what she writes with facts. We can disagree about the research (as you have) but it’s not conspiracy talk.

        2. As for Dr Jack, you may be right but we must never forget that “data” are derived from the much-derided concepts known as “anecdotes”.

        Color me cynical but even the best research by honest researchers even can be skewed and or presented in such a light as to convince regulatory bodies to rejigger policy into certain ways. We see this with changes in therapeutic modalities all the time. For example, frontal lobotomies, waterboarding and electroshock therapy were all considered to be perfectly correct psychotherapies. Likewise estrogen therapy was almost mandatory for menopausal women. Etc. (I’m sure we’ll discuss more of this in due time and I very much appreciate your input and the give-and-take which you provide to this discussion especially.)

        As a practicing pharmacist, I can assure everybody reading these words that except for some customers acting in bad faith, I’ve learned to take a lot of what people tell me re drug therapy seriously. For example: according to the FDA, any given generic drug must be “AB rated”. It must conform to the name brand drug as closely as possible. (Many are even made by the name brand manufacturer just during the midnight shift at their respective plant in Puerto Rico which has lower costs) Yet when it comes to certain drugs –i.e. Synthroid & Coumadin spring instantly to mind–there is just enough variance between the name brand and the generic that if the Dr mandates the name brand, we can override the insurance code which 99% of the time mandates the dispensing of the generic.

        What’s the point? Mainly this: that it was individual people complaining about the side-effects of certain generic drugs and/or doctors complaining because inconsistent lab results (either representing sub-therapeutic or super-therapeutic blood levels).

        • M. Stankovich says

          Mr. Michalopulos,

          I regret mentioning that what I posted from the NEJM, from the Canadian researchers, is what is on the free access material page regarding this study; the full study is available by subscription only, and I will not post copyrighted material. The full report is obviously much more detailed.

          When one says,

          I suspect this war on opiates is motivated by soon to be introduced drug(s) that purportedly have pain killing properties but do not trigger the addictive part of the brain

          one is accusing conspiratorial activities on the part of dedicated physicians, researchers, and addiction professionals such as myself – or who are at least too naive or too goddam stupid to realize they are being pawned by “deep gov’t” – who are watching addicts needlessly succumb to addiction. And apparently these “activities” include purposely misdirecting resources, funding, and even jeopardizing the safety of law enforcement in order to what? Come forth to champion, like Might Mouse, some new med that alleviates pain without promoting addiction? And this does not rise to the level of c-r-a-z-y-t-o-w-n conspiracy, Mr. Michalopulos? But then again,you championed the rationality of pedophilic “merchants” dealing children out of a pizza restaurant in Washington, DC…

          Secondly, you are absolutely incorrect in stating “we must never forget that “data” are derived from the much-derided concepts known as “anecdotes”. There is one, singular indication for anecdote in science and that is to promote research. Data derived from anecdote is folly, extraordinarily dangerous, and flat-out unethical. Jick delivered delivered five sentences to the NEJM – there was no study, no database, only anecdote – and pharmaceutical heads and others paid massive fines, and some went to jail, for misrepresentation and deceit. But how do you account for nearly 200,00 lives?

          My point to both you and Gail is a simple one: neither of you are qualified to speak to the issue at hand reliably. Gail, as soon as I read, ” It is BELIEVED that illicit use of opiates is due to the experience one has with a prescribed opioid, but I am not aware of one study that legitimately supports this,” I knew where this was headed, because anyone aware of the epidemiology of this problem doesn’t BELIEVE any such thing. I knew immediately the problem with your statement regarding Jick & Porter because I read the NEJM. And it is the FDA that sets policy, regulates, licenses, and controls medications, not the CDC. These are significant errors, and you have Mr. Michalopulos covering your back, suggesting these are my “opinions,” when they are fact. Had I not been here, they certainly would have blended into the conspiracy theme that is prevalent here.

          • Gail Sheppard says

            Michael, I supported my arguments. I would be happy to take a look at any studies you send me that support yours. I think the CDC’s arguments are flawed and I explained why.

            I do have some experience with epidemiology. I have worked in healthcare since the mid-70s. More recently, I’ve worked in Quality where I managed a portfolio of 20 or so projects for a Fortune 500 company in the Medicaid market. I have installed pharmacy systems and multiple programs to meet CMS guidelines for medication adherence. I brought up 350,000 lives in behavioral health. I know a little something about this, OK.

            The CDC released the directive I provided you, not the FDA. If CMS supports it, which they do, any provider group that receives federal money has to follow it. Many of my opinions were formed by talking to providers who find themselves between a rock and a hard place with all these “guidelines” that have become policy. They feel they can’t practice medicine anymore.

            Give me some links that show that addiction to illicit drugs is caused by exposure to a prescribed opiate. Because it is my understanding that your profession supports the disease model of addiction. So which is it? Are we all turned into addicts when exposed to opiates or is addiction caused by a combination of behavioral, environmental and biological factors?

            Don’t attack me, enlighten me! I am SO TIRED of being attacked. There is no reason for this.

            • M. Stankovich says

              I am not “attacking” you. I am an evidence-based scientist BONE TIRED of presumption, conjecture, misrepresentation of qualification, and the acceptance of the “authority” of people like Jick. I recently – and very reluctantly – attended a county “training,” where, directly behind me Dr. nobody made some moronic claim I knew, pursuant to the Cochrane Database of Systematic Reviews, was wildly erroneous. She was then “supported” by at least five other people in the room, all equally passionate about their opinion. I quietly raised my hand and asked for scientific citations that supported their claim. Silence and scowls. I sat back down. At the break, more scowls, to be followed with the same at lunch. Au revoir et bonne chance.

              If you are pissed off at me, so be it. I know the literature backward and forward, but more importantly, I am an “on the ground provider.” My days are filled with days like last Tuesday: joyfully putting into transport to a board-and-care facility a 22-year old chemically dependent felon with schizophrenia (whom I have finally convinced to accept the depo-injectable extended-release form of med to facilitate compliance), whose Positive & Negative Symptom score improved dramatically after 6-months in our care; then turning around, walking 60-feet, only to be told, “Mario (a similar patient) was found dead in a doorway downtown this morning.” How did he die? TRAMADOL. His partners saw violent seizures and left his ass cold (You didn’t know tramadol lowered the seizure threshold, making it one one of the stupidest things to give an addict? Tell her Mr. M.). Were did he get it? ER. And you would really like to know my subscribed model of addiction, or are you mocking me, a known genetics researcher? Your experience to speak to these matters is, at best, “casual.”

              I would be honoured to enlighten you and anyone else. But that would be in regard to literature you have actually read, and before you publish.

        • Billy Jack Sunday says

          Those who quickly dismiss conspiracies are not familiar with Sun Tzu’s “Art of War” military guide masterpiece, or Psalm 2 for that matter

          I find it odd for Christians to be uncomfortable with the concept of conspiracies

          The Gospel is the greatest conspiracy story ever told

          The invisible battle for our souls

          God conspired by working throughout ALL of human history, keeping His plan secret to save the world through Jesus Christ

          Satan used men to conspire against Christ. Herod and Pilate conspired to deal with their problem, which was political pressure from the conspiring Sanhedron that wanted to kill Jesus

          So they paid an insider – Judas!

          Nobody expected Judas. After all, he was the one entrusted with the entire kept resources of Jesus’ mission. If Jesus trusted Judas, why wouldn’t the disciples?

          But Jesus privately (though ultimately revealed somewhat) didn’t trust Judas. He allowed what happened with Judas to be a part of God’s secret plot against Satan. A double agent that was played

          Religious leaders conspiring with political leaders – paying off conspiring insiders to betray. Conspiracy!!

          But Jesus had disciples, then 70, then 12, then an inner circle of 3

          He kept His secret hidden, just revealing the bare minimum to His disciples so they would understand what He did after His plan was accomplished. Conspiracy!!!

          Today, we believe in a resurrected Jewish God-man rabbi, Who is Lord over all

          Something that the vast majority of humanity does not believe and finds completely implausable

          But we totally do

          We totally do, and even make related blog comments about that miraculous proven conspiracy. Then we make disparaging comments about those who are willing to speculate possible conspiracies when something is obviously fishy

          There are plenty of our friends here that will mock those who understand the nature and working of conspiracies

          Not that all conspiracies turn out to be true, but that all power structures have them on a regular basis. It’s built into the nature of conflict. Just hang around an office job for a while.

          • Gail Sheppard says

            BJS, you’re right. The greatest conspiracy story ever told!

            If back in the day I said, “Hey, there is something up with Judas. He took all this money from those Jewish guys who hate Jesus. What’s up with that?” people would have accused me of seeing crop circles back then, too.

            • George Michalopulos says

              Interesting. Reminds me of something Mark Levin recently said about the whole Russia conspiracy thing. It’s interesting that an Alinskyite tactic of “projection” is being used here. Those who are guilty of something are trying to deflect attention from themselves by accusing an innocent party of that which they themselves are doing.

              • Deep Steak says

                finally! it took a while but old george has finally caught on that trump always accuses others of that which trump does, the scales are finally off the eyes!

    • George Michalopulos says

      Gail, lots to chew on here. Can you give me the name of that drug coming down the pike? I remember seeing it on your Facebook page but I forgot it.

      And no, it’s not a “conspiracy theory” but a “conspiracy fact”. The Sackler family (the people behind Purdue Pharma started a program (with others) back in the late 40s to reorient pharmaceutical care from being mainly acute to chronic. In the 90s this kicked into high gear with OxyContin which their drug reps assured doctors all over that it wasn’t addictive.

      As an aside, it was during the 70s when Big Pharma started using women as drug reps. They made the calculation that 95% of doctor were men. At first they used teachers who were burned out by education because they’re really good at presentation of fast facts in a simple, easy-to-understand manner. In the late 90s, they started using women who had been cheerleaders in college footbal because they were even more vivacious and perky.

      I know this sounds sexist but I’ve been practicing since 1982 and I’ve seen first-hand how the demeanor of male pharmacists change when an attractive woman comes into the pharmacy to peddle the latest drug therapy for condition “X”. Back in 82 I was still a clerk and I remember the Tues after Labor Day we were getting slammed. In walk two guys with crew cuts, dry as dust and my boss said “we shoot detail men if they come in the day after a holiday”. He said it with a grin but they got the picture and said they’d come back later in the week. He never acted this way with a woman drug rep.

      Anyway, just more food for fodder. It’s amazing how medical protocols change and how they are often driven by a desire to increase market share. Think of all the disease states that are prevalent now that were never heard of back in the old days.

    • Michael Bauman says

      Gail, my wife is one who uses opioids for chronic pain. She is habituated to them. She recently found an very effective, cheap alternative CBD oil which is a hemp-cannabis derivative that contains little to no THC. She was gradually reducing her use of the opioid. Then, the AG of the State of Kansas ruled CBD to be illegal and under the same penalties for possession, use and sale as marijuana.

      We have a friend who was also finding great pain relieving benefits from CBD oil when nothing else worked.

      Now–there’s a conspiracy

      • Gail Sheppard says

        I am so sorry to hear about your wife’s struggles, Michael. It’s crazy that in CA you can walk into a store that looks like a Circle K or a 7 Eleven and buy anything you want but in other states face prosecution for making the same choices. As you said, it contains no THC and it DOES help with pain. How is it helpful to outlaw it?

        I’ll say prayers for your wife.

        • Michael Bauman says

          Gail thank you for your prayers. My wife is an old time cow girl. She has had more than one doctor look at her x-rays and wonder how she can even walk or use her right arm. Apparently she defies medical science.

          The CBD makes a really big difference for her. Interestingly enough it does not seem to do anything at all for my much lower level of pain.

          Even though we manage to irritate each other from time to time, I am blessed.

  7. Zalis Perifarmis says

    Coffee (espresso/turkish) has got to be the major cause of Mediterranean violence. Alcohol and incense have to count as drugs if you are honest. Giving women the vote led to Prohibition. Muhammad banned alcohol but the sultan Murad II who took Constantinople died because his gizzard burst from too much morphine. Greeks made ship rope and sails from Canavis (aka Canvas) and always smoked it, so did George Washington. Whenever a pope goes to the Andes they give him a mild cocaine tea to make breathing easier. German physicians prescribed the methamphetamine drug Pervitin when nazi troops felt tired or depressed and sought to enhance their energy. Afghan soldiers won over their soviet enemies with hashish the same way Vietcong won over Americans. Ancient Greeks oracles used morphine poppies. American Indian Shamanism was all about using drugs to get schizophrenic visions. Furthermore the entire hallucinatory hyperventilation of the philokalia is a drug-like thing brought over by the first Mongols, who were Buddhist before they were muslim.

    • George Michalopulos says


    • George Michalopulos says

      Before the Food, Drug & Cosmetic Act was passed in 1903 (I believe it was), a minor could go into any pharmacy in America and purchase heroin over-the-counter. For Bayer Aspirin, a prescription was needed.

  8. “It’s amazing how medical protocols change and how they are often driven by a desire to increase market share.”

    Yes… as well as provider reimbursement. And how interesting that when reimbursement for a drug or a medical test or procedure falls and they cease to be a highly profitable source of revenue, suddenly the all-important protocol “for the sake of your good health” becomes unimportant. The tests and procedures cease to be routinely performed and the drugs cease to be routinely prescribed.

    • Gail Sheppard says

      Brian, read down to the point where it says: “At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.”

      Tell me this isn’t terrifying. https://www.painnewsnetwork.org/stories?category=Pain+Medication

      • George Michalopulos says

        Gail, everybody: this hit me in the gut last night as I waited on a woman who was getting her Norco filled. She was near tears because she could no longer have a benzodiazepine (i.e. Xanax, Valium) filled at the same time. (For those who don’t know, benzos are great adjuncts to the analgesic narcotics.) She was getting ready for her 14th surgery and she wondered allowed whether she should just go to the park near her house where men were buying and selling drugs all day long.

        All I could do was listen to her. While I agree that all types of drugs in the US are over-prescribed, what the lady described to me was not compassionate care in any sense of the word.

        What will happen is that the truly desperate will get their drugs from the street and they will be of uneven quality. Heroin mixed with Fentanyl from China which will most likely kill them.

        • M. Stankovich says

          First, the FDA now provides exactly three labeled indications for the use of benzodiazepines: Alcohol Withdrawal Syndrome, refractory anxiety, and acute panic. There are 96 evidence-based meta-analyses in the Cochrane Database of Systematic Reviews dating back to 2006 regarding the use of benzodiazepines in human medicine, and there is not a single supporting indication for the adjunctive use of benzodiazepines with narcotics. I would first refer you to the June 8, 2017 issue of the New England Journal of Medicine where there is a landmark study titled, “Social Anxiety Disorder,” which is important for a number of reasons, but for this purpose, its discussion of front-line treatment for anxiety disorders and panic: “Preferred treatments include cognitive behavioral therapy and selective serotonin-reuptake inhibitors.” I would likewise refer you to the February 10, 2018 edition of the New England Journal of Medicine for their perspective, Our Other Prescription Drug Problem. And finally, most troubling is a recent study that investigated whether the initial inappropriate prescribing of a benzodiazepine in psychotic patients or patients with mood disorder actual delays their receiving the appropriate medication for their condition: “The present findings suggest that initial benzodiazepine treatment may prolong the overall duration of undiagnosed illness, although their prescription seems to be influenced by specific sociodemographic and clinical factors.” And I fight these “sociodemographic and clinical factors every time I have to send one of our dual mental health/chemical dependency patients to the ER across the street: What is the indicated treatment for acute mania? Try 15-40 mg ziprasidone IM and titrate upward. What do they always get? A Benzo. The first 200 citations in the National Library of Medicine are either examining the long-term detrimental effects of BZD, or discussing the detoxification and treatment of long-term users for cause.

          It might seem cold to say this, Mr. M., but I have heard your woman’s story a thousand times over the years. She is not a victim of the system, the CDC, or the FDA. She’s an addict. The question of her “predicament,” post-13 surgeries and so on is not “possibility,” but rather “probability.” She will go to buy drugs off the street? Bullshit. She will con, manipulate, cry, falsify symptoms, steal from friends and family, beg family and/or friends to get prescriptions for her, and forge prescriptions until she is caught. I will say this much, Customs & Naturalization is an astute group with a ton of dogs at the border, sniffing around everybody walking across the border from Mexico and driving across, and major profiling & questioning, and there is significantly more pressure on Mexican discount pharmacies to demand prescriptions for US controlled substances.

          When I started working with addicts in the criminal justice system, a judge referred a woman with young children to see me for an assessment – one decision being made was whether she should retain custody of her children. An hour before the appointment, she called me, very upset and in tears that she could not find anyone to watch her children, so I rescheduled her. A week later, she repeated the same call. I told her I needed to check with my supervisor before I could reschedule again. I went to my supervisor and explained the situation; she asked, “What line is she on?” I told her and she picked up the phone and said, “You didn’t give a damn about your kids when you were out copping dope. You have your ass in here on time or you’re going to jail” and slammed the phone down. I was stunned. The young lady was on time and never mentioned her “difficulty.” This was the same supervisor who told me she didn’t believe a man’s name without two forms of ID, one had to be a state-issued ID with his picture.

          Grancini, B., DeCarlo, V. et al. “Does initial use of benzodiazepines delay an adequate pharmacological treatment?: a multicentre analysis in patients with psychotic and affective disorders.” Int Clin Psychopharmacol. 2018 Feb 15.

          • Gail Sheppard says

            RE: “. . . there is not a single supporting indication for the adjunctive use of benzodiazepines with narcotics.”

            Providers have been prescribing benzodiazepines with opiates for YEARS. If that weren’t true, why would the CDC try to uncouple them?

            Seriously, Michael, WAKE UP and read the CDC directive, specifically where it says: “Scientific research has identified high-risk prescribing practices that have contributed to the overdose epidemic (e.g., high-dose prescribing, overlapping opioid and benzodiazepine prescriptions, and extended-release/long-acting [ER/LA] opioids for acute pain) (24,33,34).”

            You need to be in this fight and you can’t be if you’re not seeing what’s transpiring.


            What is an addict? Is someone who is dependent upon insulin an “addict?” What about someone who needs thyroid medication or statins or diuretics or channel blockers? If someone is dying of terminal cancer and they need anti-anxiety medication just to get through their goodbyes with their family, does that make them an “addict,” even though they will never withdraw from the drug or have deleterious results? What if someone is in so much pain that they can’t sleep at night and Xanax helps with this? Is that person an “addict?” “Addict” is a loaded, pejorative word. I think we need to redefine this term if it applies to people who are legitimately prescribed a drug and are compliant.

            • George Michalopulos says

              Gail, I’ll pull rank here and state that regarding the co-administration of benzodiazepines and opioids, I don’t care about what the literature says, I’ve seen with my own eyes that they are extremely useful for the management of chronic pain. Too many people have told too many times that this is true.

              This of course does not go against the idea that opioids have been over-prescribed for mild to moderate pain. They have. But then the US drug market has resulted in the over-prescription of basically any class of drug there is. It’s frightening really. My European relatives cannot believe who drugged up we are in this country.

              Something had to be done, unfortunately, whenever the govt gets involved, it’s always the wrong thing that’s being done. As we learned with the Syosset coup against Jonah, when the only tool you have is a hammer, every problem looks like a nail.

            • M. Stankovich says

              Here in CA, the laws were changed in 2016-7 to restrict the use of BZD’s (e.g. a new prescription for each refill, and the use of a special unalterable prescription form). Before each prescription for a Schedule IV-II medication, a physician is obligated to check a state prescription drug monitoring program (PDMP) of the patient’s purchases of Schedule IV-II medications to see if other providers have prescribed the same medications. The PDMP monitors physician prescribing records for controlled substances and patient purchases. These precautions were taken in acknowledgement of the medical community’s call for the reduction in the prescribing of BZD and the education of providers as to the dangers of their use.

              It is impossible that either of you read the perspective in the New England Journal of Medicine, “Our Other Prescription Drug Problem” I cited above. I’m not seeing what is happening Gail?

              8791 BZD related deaths in 2015, Three quarters of these deaths involving benzodiazepines also involve an opioid, which may explain why, in the context of a widely recognized opioid problem, the harms associated with benzodiazepines have been overlooked.

              As I also said above, yours is a Google scholars’ casual relationship with this problem; twice a week, I walk into a meeting room full of patients waiting to hear the medical consequences of drugs of abuse, and I tell them, “If you were taking BZD’s and you stopped to come in here, you need to be honest and tell the doctor or the nurse, because you could have a seizure as late as two weeks after you stopped.” How many times have I seen a patient drop into an “unexplained” seizure and wait for the paramedics to arrive; how many times have I seen the woman exactly as Mr. Michalopulos described, coming into the community clinic because she lost her prescription, or someone stole it, or it was to early to refill her prescription and she was afraid she would have a panic attack. A friend of mine at a medical center called me to say he had seen a former patient of mine, a young woman who had been a Playboy centerfold, and to whom he had given a prescription for a BZD for anxiety. He told her specifically to take it exactly as prescribed or he would not refill it. A pharmacy called to say she was trying to refill it early and he refused. She came to his office, and when he agreed to see her, she swept everything off his desk emptied his bookcase, and threw a plant at him. She was arrested. It is a constant scourge in our treatment facility – in any treatment facility I’ve worked in – because it is so readily available on the street for parolees & probationers to get. Someone acting “different?” Rapid test them and they may have meth or marijuana in their system, but always a BZD. And anecdotes aside, I refer you to the first 200 citations regarding BZD in the National Library of Medicine, sorted by most recently published, nearly exclusively speak to the issues the negative consequences of long-term use, the harmful consequences of their use in general, and the detoxification and treatment of BZD users. As The NEJM citations and the information I offered clearly state, the research is clear that insomnia, anxiety, and panic are better and more safely treated with other medications and cognitive behavioural therapy; and there is a strong emphasis on psychotherapy for pain and anxiety patients no one has mentioned .

              And finally, let me educate with a clear distinction of the terms addiction and dependency for you: the term addiction means the use of a drug producing a physical adaptation, that with abrupt cessation results in an acute withdrawal syndrome. Obviously, the abrupt cessation of insulin will not result in an acute withdrawal syndrome despite the fact it is used daily. People who use narcotics for pain relief for longer periods, for example, as the result of trauma, will experience a withdrawal syndrome if a narcotic pain medication is abruptly withdrawn; they must be gradually reduced – in effect detoxified – from the narcotic for a period of time. They are not necessarily dependent. Physical addiction to a medication for a medical reason is hardly a pejorative. It happens quite frequently.

              Dependency is defined as the use of a drug that results in a harmful life consequence, and despite the harmful life consequence, the individual continues to use. This condition is characterized by “loss of control,” meaning that without plan or intention, once using the drug (and this obviously includes alcohol), the individual cannot predict the outcome i.e. while my plan was to have a pleasant evening with friends, I was using until 0500, missed a day of work, disappointed my family, etc. Attempts to “change” this outcome become more improbable because its occurrence is unpredictable. This adds to the definition, the fact that dependence is the loss of the ability to reasonably predict the outcome once use begins. Those who are dependent are not necessarily addicted, though the term addict is often used interchangeably. The term chemical dependency is used commonly, as is the DSM-V designation, Substance Use Disorder.

              As I have noted so many times, your arguments are sine quibus non the reason we do not act according to “what I see,” or “what somebody told me,” or what Google happened to spit out. I need to wake up? I repeat that I am an on-the-ground provider who can match your anecdotes 10-1 with the ravaged lives of real human beings who used BZD’a, presenting with all the cognitive and neurological deficits the textbooks describe that will not be repaired. What we need to do is rely on the evidence-base of practice, not debate loaded questions such as my “school of belief” and the underlying meaning of common terminology.

              • George Michalopulos says

                Dr S, as always, thank you for your reasoned opinions in this (and other) matters.

                My first instinct is to recoil in horror from the chaos that is being perpetrated upon the patients and those who provide health services to them in the once-Golden State. That is insane. As bad as things are getting for us in the other 49, it seems like a walk in the park compared to the protocols you describe.

      • Gail,

        As someone in the industry who is simply attempting to service the legitimate needs of physicians and ambulatory surgery centers, I can attest to the factual, real-life accuracy of the article to which you linked.

        George’s perspective is as a pharmacist serving patients’ prescription needs. Mine is as one who serves those who perform surgeries. Every single drug used for pain in surgical procedures is either in extremely short supply or simply unavailable as a result of this madness. I now spend hours each day scrambling for possible alternatives and keeping my clients informed of uncertain inventory statuses and lead times (which can be as long as months).

        This is so typical of government. Don’t follow your own laws. Don’t go after the extremely few “bad apples.” Instead, make everybody’s life miserable so you can tell the public you are ‘doing something’ about the problem.

      • Michael Bauman says

        Get us hooked, restrict the supply. Scapegoat someone. Government control of healthcare=government control of the population. Who, how and when folks die.

        It is part and parcel to the nihilist anti-culture.

        Destroy the herd so that the Ubermenschen triumph. The satanic will at work.

      • M. Stankovich says

        You are not being forthcoming in your report that the DEA has called for a reduction in the production of opioid painkillers in an attempt to reduce the misuse. The FDA, for example, has moved to eliminate redundancy, and is asking manufacturers to voluntarily remove from the market formulations that are known to be the targets of abuse specifically because of their formulations. Case in point, Opana (Oxymorphone) manufactured by Endo Pharmaceuticals, Inc.

        Oxymorphone is a potent opioid that has a three to five times higher μ-opioid receptor affinity than that of morphone, and is equigesic to oxycodone at half the dosage. The delivery system was changed several times by the manufacturer because it was first defeated to be crushed and snorted, then defeated to be crushed and used intravenously. Opana voluntarily carried the following “Black Box Warning” after both defeats:

        OPANA ER- oxymorphone hydrochloride tablet, extended release

        Endo Pharmaceuticals Inc.


        See full prescribing information for complete boxed warning.

        OPANA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.

        Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow OPANA ER tablets whole to avoid exposure to a potentially fatal dose of oxymorphone. (5.2)

        Accidental ingestion of OPANA ER, especially by children, can result in fatal overdose of oxymorphone.

        Prolonged use of OPANA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

        Instruct patients not to consume alcohol or any product containing alcohol while taking OPANA ER because co-ingestion can result in fatal plasma oxymorphone levels.

        Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

        The FDA gathered an advisory council representing of a variety of specialists in the medical, addiction treatment, pharmaceutical manufacturing & marketing, and consumer interests that met for two days in March, 2017 to hear testimony on whether the FDA should ask Endo Pharmaceuticals Inc. to voluntarily remove Opana from the market “because the benefits no longer outweighed the risks.” The advisory council voted in favor by 18-8 (the 8 dissenting were not opposed to its withdrawal from the market, but unconvinced it would make a substantial difference). Personally, I don’t find decisions like these “terrifying” in the least. Is this discussion headed for something analogous to our 2nd Amendment right to “bear arms” vis-à-vis narcotics? Smells like teen spirit…

        • Gail Sheppard says

          Michael, you do realize that Brian was talking about drugs that are injected into IVs in hospitals, right? He’s not talking about tablets.

          Google “opiate shortage hospital” and you will see that everything we’ve said has been widely reported.

          You’ll have to forgive those of us who do not share your magnanimous view of bureaucrats, especially in healthcare. Were you on these committees you so vigorously defend? Are you directly involved in making decisions regarding the “crisis,” which is so clearly related to the affordability and availability of fentanyl-laced heroin, dwarfing any and all other causes? Or do you defend them because you want so much to believe in the institutions that have served us in the past and are no longer doing so? It’s a hard reality to face, even for me.

          That the CDC combines heroin deaths with deaths resulting from prescribed opiates should tell you that THEY are the ones who are not being forthcoming.

        • Michael S.,

          What I can tell you with absolute certainty is that the following statements in the article to which Gail linked are true. Note that my area of expertise is injectable drugs used in surgeries. I cannot speak to those dispensed by pharmacists.

          Pfizer Manufacturing Problems

          The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.

          A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kansas.

          The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.

          That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.

          Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.

          And it isn’t opioids alone. Even common locals like Lidocaine and Marcaine are in extremely tight supply. Name any drug that has been available as a generic for years, and approximately 40% of them have been completely unavailable for months now with a large percentage of the remaining 60% on constant rolling back-order because the existing production capacity cannot meet the demand

          Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl….When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.

          “But they didn’t,” he said.

          No. They didn’t. Even though they knew the FDA had Pfizer at less than half their normal production and that they wouldn’t recover until June at the earliest

          The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.

          This group is/was fortunate at the time of being quoted, as Ketamine hasn’t been available for over a month now.

          And this doesn’t even speak to the shortages of IV Solutions (Sodium Chloride. Lactated Ringers, etc.) that have been ongoing for well over three years now – long before Hurricane Maria shut down Baxter’s plant in Puerto Rico. Maria hit that island in September of last year(!), literally creating critical shortages, yet only about three weeks ago did the FDA finally give approval to import enough IV Fluids to take us from critical back to ‘mere’ ongoing shortage.

        • Take a look at the list of all the shortages, that is, if you have the patience to scroll through all the pages. And you have to click on each drug to see all the strengths and package/vial sizes to get a sense of just how outrageously bad the situation is and has been for several years.

        • George Michalopulos says

          Dr S, this is one of those rare occasion in which two people who hold opposite views regarding a single phenomenon are both correct. You as well as Gail.

          You are right that the government is (wisely IMHO) decreasing “redundancies” in the analgesic market. Opana (Oxymorphone HCl) should have never been developed in the first place. Having said that, its availability has “dried up” the market (so to speak) by creating undo competition with the cheaper analgesics (i.e. Vicodin, Norco, etc).

          The practical effect of what I mean is that since all retail pharmacies are given a monthly allocation on CII narcotics (for those who don’t know there are five “schedules” of controlled substances with CII being the most highly restricted legal category), Nucynta and Opana have taken up unnecessary space on the shelf. This has created downward pressure on the typical Hydrocodone allocation.

          It’s gotten so bad these last few years when every month around the 23rd of that month I am literally out of Oxycodone and Hydrocodone and have to turn people away. In other words, I can’t reorder either one until I execute a new DEA-222 form until the first of the month arrives and a new allocation is in place.

          Gail, you are correct in that diversion is the reason why there are many innocent people suffering. Likewise she is correct to point out that the Feds are not targeting those who abuse diverted drugs (and participate in the diversionary market) but is instead putting pressure on physicians to be unnecessarily stingy with the proper prescribing thereby causing unnecessary pain and suffering for those in legitimate need.

          The question is: is this by design (a feature) or is this due to incompetence (a bug). I’d like to think that this is because any bloviated institution inevitably succumbs to bass-ackwardness and priorities get horribly skewed. I’ll give an example at another time as I gotta get ready for work.

          Regardless, none of this would have come to light were it not for Brian who has shed immense light on this problem (admittedly from a hospital perspective, to which I am not privy).

          It’s a hot mess.

          • I do not see a conspiracy, but the incompetence is beyond belief. This is what happens when regulatory agencies, each with their own agendas (which, in general, I do not question), with overlapping impacts fail to communicate and/or recognize the combined impact they have on our health system.

            I cannot say the same for how the DEA has approached the opioid crisis. They have the tools (and have had them for as long as I can remember) to figure out how these drugs are getting into the wrong hands. What they obviously lack is the will (or, perhaps, the staff) to do so. And I haven’t heard any complaints about lack of staff in media reporting.

            • George Michalopulos says

              I hope you’re right.

              • George,

                If there is a conspiracy it is on the part of the drug manufacturers. When a plant is shut down by the FDA (as has happened more times than I can count over the last six years), it creates shortages because the other manufacturers (if any) do not have the capacity to meet the demand. When the remaining manufacturer(s) finds itself in the enviable position of being the only supplier, they raise the price to astronomical levels. Just a few examples:

                American Regent was for many years the primary source for Cyanocobalamin, commonly known as Vitamin B12. A 30ml vial sold for about $10.00 for many years. After the FDA shut them down their only competitor raised its cost to over $100.00 for the same amount. Now that American Regent is finally recovered, their cost is ‘magically’ just as high as the competitor.

                Following the same scenario, a 1ml vial of Adrenalin Chloride (Epinephrine) went from $1.29 to over $10.00. I won’t even mention the outrageous increases in the cost of Epi-pens (which contain the exact same drug), but this should give folks some idea of just how inexpensive the drug itself in an Epi-pen actually is and just how much profit our friends at Mylan are making. For those who don’t know, an Epi-pen now costs about $260.00 or more.

                The list of injectable drugs and their rising costs following this scenario is almost endless.

                How is this possible? It is made possible courtesy of our government. Medicare reimbursement rates to hospitals and licensed Ambulatory Surgery Centers (which is also the formula used by other insurers) are based upon what is known as WAC (Wholesale Acquisition Cost) plus a small margin. As the WAC rises, so do the rates of reimbursement within six months when Medicare updates their payment rates. Thus there is no incentive to contain costs at the manufacturing level. There are some exceptions to this rule such as oncology and some other specialty drugs. ‘Magically,’ the manufacturers of the drugs to which these exceptions apply manage to keep their costs slightly below the applicable Medicare reimbursement rate.

                In short, if they can afford a short-term loss from a plant shut-down, drug manufacturers can realize ten times (or more) greater profits on their products once they return to market. Nice gig, if you ask me.

                Now it is only fair to point out that the regulations to which these manufacturers are subject are onerous, and the costs of building and maintaining plants in compliance with FDA standards is extremely high compared to that of other counties. But if you want to know why healthcare costs in the U.S. always rise at a much higher rate than other industrialized countries, this one of the main reasons – among several others that do not pertain to the subject at hand.

          • George,

            I just realized that when you asked..

            The question is: is this by design (a feature) or is this due to incompetence (a bug).

            … you were apparently referring to the DEA’s

            “not targeting those who abuse diverted drugs (and participate in the diversionary market)…”

            …and not the shortages that prompted my comment that I don’t see government conspiracy in the shortages.

            There may well be conspiracy as far as diverting attention from the DEA’s lack of enforcement goes. The companies being demonized have deep pockets. and “big business” makes for an easy target in the public eye. Only recently our old buddy Rahm Emanuel was, I believe, the first among what will doubtless become many governments, organizations, and individuals, to announce lawsuits against these distributors.

            As with most everything, it’s likely a case of following the money. Who will gain from these suits? Those suffering? Yyyyeah… sure. And heaven forbid that government be should ever be held accountable for failure to enforce its own laws. Though Alinsky is dead, his master is not.

  9. I feel compelled to make an additional comment about distributors of opioids. The process of ordering opioids is largely unknown to the general public. As a pharmacist, George can attest to the accuracy.

    First of all, wholesale drug distribution is a business. Are the distributors greedy? Absolutely. They are in business to make money.

    Second, the profit margins of these distributors are razor thin. The sales are in the hundreds of billions and the profits are enormous in terms of dollars, but the profit margin is tiny – usually about 1-2%. Unlike drug manufacturers who often have extremely high profit margins due to exclusive patents for their products, the three major wholesalers merely distribute, rather than produce, all the same “me too” drugs; and the price competition among them is fierce.

    Third, compared to other drugs opioids are very inexpensive and not even close to being as profitable for distributors as other drugs (for reasons explained below). An average dose of injectable Fentanyl, for example, costs about $2.00 (more or less) at the wholesale level, meaning that this is approximately what a pharmacy, physician, hospital, or ambulatory surgery center pays their distributor for the drug. Thus a package of 10x2ml 50mcg Fentanyl sells for about $20 with a profit to the distributor of about $0.40 (cents).

    Now to the meat of my comment.

    In order to purchase opioids or any other controlled substances classified by the DEA as CII, the following is required of the purchaser and the distributor.

    Either a DEA Form 222 or its electronic equivalent submitted through a system known as CSOS (Controlled Substance [electronic] Ordering System) must be completed by the purchaser. Only purchasers with valid, address-specific, verifiable Federal DEA (and State) licenses to purchase Controlled Substances have the ability to obtain 222 forms from the DEA or an electronic CSOS signature (also provided by the DEA after a approximately six week period of validation performed, again, by the DEA) to purchase through the CSOS electronic system. Those qualified in either case are licensed by the DEA itself. Every time an order of any size for CII substances is placed with a distributor, the DEA is notified of the shipment – either via their copy of the 222 form within days or in real-time via the CSOS.

    In other words, the DEA’s own system ensures that the DEA knows precisely what is ordered, when it is ordered, who is ordering it, where it is being shipped, and the quantities of every single purchase. The only way the DEA would not know precisely where these opioids are ending up is if these distributors sold these products illegally. And, importantly, it has never even been alleged that any of the “Big Three” distributors failed to follow the law or DEA’s own processes.

    What has been alleged is that distributors “looked the other way” as orders from some pharmacies/providers increased in size. However, consider the following scenarios that occur every day in such a business.

    Let us say George, a legitimate, fully licensed pharmacist, chooses to leave his employer and open his own pharmacy. As a new business his orders start out small, but as his business grows, so do his order quantities. George may also find that providers in his area find him to be a convenient source in place of the somewhat cumbersome process that small medical practitioners face in dealing directly with the “Big Three” for the meds they use in their surgeries. George also must follow the same DEA laws and procedures outlined above as a reseller, but the providers can obtain needed product in a more timely fashion because they can drop off the 222 form in person and pick the meds up rather than mailing the form and waiting for the shipment. Or a new Surgery Center opens. Again, their orders start out small, but as their business grows and their surgeries increase, so do their orders.

    The key aspects to this that I have yet to hear mentioned in any of the reporting about this opioid crisis are these:

    1.) No opioids distributed by the “Big Three” Pharma distributors make their way to any person apart from either a licensed physician administering them and/or a licensed pharmacist dispensing them. I repeat that no allegation to the contrary has ever been made by anyone.
    2.) The DEA itself controls the licensing, not the distributors.
    3.) The DEA is advised on a daily basis precisely who is receiving these drugs and in what quantities.
    4.) If the DEA sees anything they deem suspicious in ordering patterns (which is, after all, one of the primary purposes of the process the DEA established in the first place), they have the authority to investigate the licensees and can easily ascertain from pharmacy prescription records and/or their resale records whether there is diversion through the pharmacy and/or specifically which physicians are over-prescribing (as well as even who the specific patients are for whom they were prescribed); or in the case of physicians and medical facilities, whether their patient/surgery load justifies their purchases.

    The “Big Three” pharmaceutical distributors are very big and very politically influential. Of that there is no question. The entire pharmaceutical industry in the US, from manufacturing to distribution to government reimbursement policies that do nothing to discourage rising prices at the manufacturing level, is thoroughly corrupt. But these are not issues related to the current crisis. So the question is, why are companies who do not stand accused of disobeying the law demonized when under that same law the DEA alone has the mandate and the legal powers of enforcement?

    • George Michalopulos says

      Brian, brilliant analysis! You’ve got the complexity down pat. But it’s even more complex when it comes to returning expired CII medications (i.e. morphine, Dilaudid, Fentanyl, Norco, etc.). A different set of DEA 222 forms must be used in which the pharmacy is the source while the DEA is the final “vendor”. I hated to watch them go out of date because of the rigmarole involved and fortunately I tried to keep the inventory as lean as possible because some items didn’t jump off the shelf. I didn’t have to worry about this with Norco (Hydrocodone/APAP) or Percocet (Oxycodone/APAP) because those things flew off the shelves.

      And then I dreaded every 25th or so of the month when I’d get a call from corporate HQ wondering why I had exceeded my limit of CIIs for the month. That would happen around the same time that the wholesaler would call and inform me that I’d exceeded my quota for the month.

  10. Working where the opioid epidemic is very visible, and cannabis is legal, I believe cannabis should be used to treat opioid and alcohol addiction, and be embraced as an alternative for addressing pain and anxiety. Working in social services for nearly two decades, I see good people ravaged by heroin, meth, alcohol and every other variety of opioid available in the Pacific Northwest. The prescription drug problem is far more visible and important to me than popular media narratives of North Korea, terrorism, ‘unhinged’ presidents, etc.

    My sense of the general Orthodox attitude is toward cannabis these days is optimistic. I personally know a handful of priests, a few bishops and some monasteries who treat it as, well, natural medicine for the sick, and dying. God did give us cannabinoid receptors for a reason, and their only use is for the reception of THC, so far as I know. Cannabis isn’t the harbinger of demonic delusion together with card playing, alcohol and dancing, although many of the people I know who use cannabis, medicinally, do find it much safer than those vices. But I wouldn’t recommend it to forming brains any more than I’d recommend i-gadgets, media and social media, and the horrifying number of anti-depressents and caffeine consumed in our culture.

    • I get that medical marijuana can really be of assistance to people. I get that. What concerns me still is the potential (if not the inevitability) of medical use giving way to all out recreational/’medical use’, and the definite psychological problems such use/abuse can help create. What I’m saying is that this proposal for medical use, which is already somewhat widely accepted, can’t be considered independently of other social mores, such as the current craze for (false) equality. In that light, we’ve recently seen, for example, the developed world swept away in a tide of gay friendly activity, one of the consequences being the acceptance of gay marriage.

      Rampant (false) equality plus widespread homosexuality (whether in act or just in sympathy) eventually equates to the legalisation (not to mention the celebration) of bestiality. It can only go that way. In following these same laws, we can begin to see that (false) equality plus widespread medical marijuana (whether in act or just in sympathy) eventually equates to the abuse of marijuana by people not in need of it.

      The ‘logic’ in both cases described above goes that if gays/actual patients are needlessly suffering, then so too are those who ‘love’ animals/are bored, and in the interest of ‘being fair’ we must help them, too. Anything else would cut against the grain of the thinking of these times, and so I’m reluctant to add my support to medical marijuana.

      I understand that other medical drugs haven’t gone on so much to become recreational drugs, and yet I see a difference between these and marijuana i.e. these other drugs either didn’t start out in popular culture with a recreational stigma, or are just not as conducive (by their nature) to being truly recreational.

      As for what’s to be done for the few who genuinely benefit from medical marijuana, and would therefore be disadvantaged by its continued prohibition, I’ll leave that open to someone with more qualifications than me.

      • M. Stankovich says

        This is not logic, this is lunacy. This is like asking the question, “I have a terrible cough. Isn’t that a symptom of lung cancer?” If I answer, “Yes it is,” and your real question was, in fact, “Do you think I have cancer?” I have told you nothing except possibility. The point being, there is a distinct difference between possibility and probability. Your logic is based solely on the “possibility” that our society will except sexual relationships between humans and animals driven by human “boredom” and “in the interest of being fair.” My logic says, “But how probable is this to occur, realistically?” Beside the fact that sexual contact with animals provokes a “natural revulsion” in the overwhelming majority of humans and is considered a mental disorder, it would likewise seem necessary for you to demonstrate that our society has “codified” a universally revulsed practice pursuant to the criteria of “boredom” and fairness.” As to your understanding of “other medical drugs haven’t gone on so much to become recreational drugs,” I would direct your attention to the history of cocaine, used as a topical medical anesthetic and popular commercial stimulant (hint: coca-cola). I must admit that your association of medical marijuana & homosexuality is fabulous entertainment – even by Monomakhos standards – but it is fabulous lunacy.

        • Stankovic, it’s logic, like I said in the first place. Everything you’ve said against it is non-exhaustive.

          For instance, Stankovic, how ‘probable’ was it even 50 to 100 years ago that today many, many people would be dancing in the street celebrating homosexuality? The answer is very ‘improbable’ and yet there it now is for all to see.

          You say, Stankovic, that people feel a natural revulsion to ‘loving’ animals, and then deny the wide acceptance of it by society on this. Do I need to remind you that almost everybody, but a minority, used to feel (and still do) repulsed by homo-sex, and yet despite that it’s still now widely celebrated, and growing?

          Are you not able to see the parallels between what was once unthinkably hip (homosexuality) and that which is still unthinkably hip (bestiality)? – both being analogous in that all it takes is a good enough number of irrational bleeding hearts to want to normalise the abnormal, in the name of ‘equality’. Are you able to join the dots yet? Or do you dream that humanity is evolving?

          And as for your reference to cocaine, note well that the comment of mine you were responding to was not absolute. I didn’t say no medical drugs haven’t become recreational, I merely said they mostly haven’t. Do you get the difference? And for all that, the only one you could come up with was cocaine. How excited you must have been when it came to mind, but what a shame for you it was beside the point.

        • Stankovic, it’s logic, like I said in the first place. Everything you’ve said against it is non-exhaustive.

          For instance, Stankovic, how ‘probable’ was it even 50 to 100 years ago that today many, many people would be dancing in the street celebrating homosexuality? The answer is very ‘improbable’ and yet there it now is for all to see.

          You say, Stankovic, that people feel a natural revulsion to ‘loving’ animals, and then deny the wide acceptance of it by society on this. Do I need to remind you that almost everybody, but a minority, used to feel (and still do) repulsed by homo-sex, and yet despite that it’s still now widely celebrated, and growing?

          Are you not able to see the parallels between how what was once unthinkably hip (homosexuality) and that which is still unthinkably hip (bestiality)? – both being analogous in that all it takes is a good enough number of irrational bleeding hearts to want to normalise the abnormal, in the name of ‘equality’, ‘freedom’ etc. Are you able to join the dots yet? Or do you dream that humanity is evolving?

          And as for your reference to cocaine, note well that the comment of mine you were responding to was not absolute. I didn’t say no medical drugs haven’t become recreational, I merely said they mostly haven’t. Do you get the difference? And for all that, the only one you could come up with was cocaine. How excited you must have been when it came to mind, but what a shame for you it was beside the point.

          • M. Stankovich says

            Apparently, chief, you missed the course on statistical probability – it is, after all, considerably more than a coin toss. Catch it on the next go round. I say this to suggest that if you had caught that course, you would see the enormous leap from, not “loving” animals, but from “loving” animals to having sexual relationships with animals. Do you see the difference? And it was you who set the parameters of societal acceptance to be “boredom” and “equity.” I will end this foolishness by simply saying that the practice of homosexuality has been famously “tolerated” if only by simple benign neglect and “looking the other way,” with no “celebration in the streets” whatsoever. Did I personally find it within the scope of statistical probability that homosexuality would be given “civil rights” in my lifetime in the evolution of this godless society and the failure of the Church to maintain a moral presence and voice? I sat in a shopping center parking lot in NY and heard the announcement of the Rowe v. Wade decision as an 18-year old, without the Church doing anything appreciable as a moral witness before or after and believed it probable. Nevertheless, your contention bestiality is “hip,” in the same league, and probable is lunacy. Trust me bro’. I’m a smart guy, and this concludes my participation in lunacy.

            • George Michalopulos says

              Dr S, I must disagree. Whatever the etiology of homoerotic passions, the plain fact remains that once sexual restraint is removed, then it’s Katy bar the door. Now mind you, the first restraint that was removed was heterosexual chastity and that was thanks to the “Playboy philosophy”.

              Having said that, I realize that there probably never was a golden age of chastity but instead a golden age of hypocrisy in which everybody paid lip service to it. But as Churchill said about hypocrisy, it “is the tribute that vice pays to virtue”. You can tell a lot about a culture based on what it pays homage to.

            • Dr Stankovich,

              We could on, it’s true, but I agree with your implication that there’s no point. Everything that I needed to say to anything anyone could possibly say was included in my last post – explicitly or otherwise. For those who can see this, great. For those who can’t, no worries.

            • Dr Stankovich,

              If I’m being honest, I think my last response addressed all of yours. But still we disagree. No worries.

              Thanks for your input

  11. I think the reasons given for why illicit drugs won’t be legalised are fair enough. Still, I see room for expecting that they will eventually become legal. The crux of this prediction rests on the ultimate distinction between Orthodox Christianity and satanism: the former recognising mankind as fallen and with its sights now set on the Heavenly Kingdom, while the latter strives towards some kind of ‘heaven on earth’. Thus, while the heights of Orthodox Christianity encourages asceticism (and all the rough living this implies), satanism is bent on luxury and comfort, so as to show everyone who’s really ‘in charge’. This aim of satanism, as we can see, is closely related to certain branches of heretical gnosticism which posit that the earth, and all its suffering, is but the work of a maniacal demiurge, thus charging everybody with the responsibility of defying its evil schemes and becoming gods that can and will rise above. Certainly, freemasonry and the like fit this description, with their ‘god-like’ powers that can help them manifest at will.

    So, if satanism is to ever win everyone over, it will want to make good on its ‘promise’, and I see illicit, mind altering and mood enhancing substances as playing a crucial role in that. After all, what better ally could the false religion of the devil have than substances which invoke in someone the false euphoria of the demons? In that regard, it’s worth citing here the book by Aldous Huxley, A Brave New World, which all but invisions, somewhat prophetically, just this kind of scenario i.e. a society hopped up (not so much by force, but by force of social habit) on ‘feel-good’ pills, while they go about getting ‘ecstatic’ at their ‘church’. To my mind, a scene such as this seems to be the logical conclusion of the devil’s fall from grace and mankind’s expulsion from the Garden; each in their turn looking for godliness independent of God.

    Indeed, the devil’s greatest weapon, as we know, is that he appears as an angel of light, if not the very Lord Himself, and yet this ruse can only go on for so long until it’s up. Sooner or later Revelation will show things for what they are, and there’s nothing more repugnant than Gehenna. Be that as it may, the veil is still fastly drawn, allowing this imitator of Life to do ‘good’ things. This, ultimately, is the ‘heaven on earth’ discussed above, and the ‘benefits’ of illicit (for now) drugs will only sell it.

    Currently, the developed world is (strange to say) still relatively guarded by the influence of Christianity and this provides us with whatever resistance is left to the above scenes playing out in full. That said, it is too easy to see that we are perhaps but one generation away from a generation of complete radicals, the only distinction to come from them being their drug of ‘choice’.

    All things considered, now, I will admit that the future antichristian state of things needn’t be as homogenous as this, and yet I won’t be surprised if it’s at the forefront.

    • George Michalopulos says

      Brilliant! Much to think about here. If anything, your bringing in Gnosticism (in all its forms) into this calculus solidifies suspicions I have.

    • Michael Bauman says

      Stefan, one must also take into account the “extension of life” drugs and technologies in your scenario. Somewhere in all of that AI also has a place in bringing about the secular eschaton don’t you think?

    • M. Stankovich says

      I believe you need a lesson about chemical dependency, and for that I suggest you take in a few self-help meetings – AA, NA – and listen to people in recovery; hear their stories of helplessness & hopelessness, not “false power,” and of the depth of shame you can only imagine, that drove the urges for the next drink or drug, not “a brave new world,” satanic and gnostic. Your interpretation is book or movie-derived fantasy, while the real motivation of chemical dependency is experienced in the suffering of the emotional human being, psychologically, morally, ethically, & spiritually, manifested in negative consequences biologically/medically, socially, legally, occupationally, and profoundly, and frequently irreparably, impacting the most important relationships in their lives: parents, siblings, spouse, children, and friends. To refer to this as purposefully “satanic” or “gnostic” is flat out foolishness, and they are no more “satanic” than you or me in this broken creation and in our fallen humanity, brought about by our purposeful arrogance and disobedience. At least they may claim that they looked and misinterpreted the depth of their impairment and behaviour because of a mood-altering drugs, while St. John Climacus even points to his own “sinful eyes” that saw a brother do some thing, misinterpreted his action, and thought badly of him. Only at the brother’s death bed did Blessed John see his great piety and humility before the Lord and was ashamed. He warn us “not to believe everything we see, and judge it” for many have been fooled. And pay attention here: it was not a mood-altering substance that drove and altered this great saints’ perception of what he saw and how he interpreted it. It was his his own sinful arrogance.

      Go to a few meetings and then tell me your opinion.

      • Stankovich, everything you’ve said (in so far as the broader picture you were painting goes) supports what I said. It’s amazing you thought you were contradicting me

        • M. Stankovich says

          Chief, you have obviously missed something in what I wrote if you conclude I have supported you.. But I am finished.

          Let me say to you that you are welcome to refer to me as Mr., Dr., M., or preferably, Michael, but I find it exceptionally rude of you to simply, and quite disrespectfully, refer to me by my last name alone, particularly when you don’t know me, nor share your own last name.

  12. M. Stankovich says

    This week in the England Journal of Medicine, there is a report of the the current ongoing shortage of sterile saline in water – notably “.09% Sodium Chloride, small volume bags,” that began in 09/25/2017 and has reached critical levels. The Journal notes that, while saline is an inexpensive product, “Production demands are challenging, since very large quantities are needed: more than 40,000,000 per month. Saline is required for virtually all hospitalized patients, whether as a component of a medication infusion a or as a hydration, resuscitation, or irrigation fluid. Unfortunately, shortages of saline have become commonplace in recent years. Further, they note, as did Brian, that most shortages occur because we rely on three or fewer suppliers; in the case of saline, three. One of the US suppliers, Baxter International, who supplies more than 50% of all US hospitals with saline (and are not required to have any redundancy or a contingency plan in the event of disaster), was devastated by Hurricane Maria at their facility in (drum roll) Puerto Rico. The two other suppliers are too small to make up the deficit, one of which was even cited for quality problems before the hurricane. Large-volume products (>500 ml), which are used for maintenance, resuscitation, or irrigation had actually begun the shortage in 2014 because of high demand during the severe influenza season and a series of manufacturing problems. Without saline, it becomes necessary to dilute medications with less familiar substitutes, which necessarily increases the chances for “dilution errors, drug interactions and adverse events, and microbial contamination.”

    Neither the congress, nor the president, nor the FDA can force a manufacturer to produce a medication, no matter how compelling or lifesaving the production might be, how critical the need, or how much the production might benefit the community as a whole. Incentives – such as tax relief or accelerated approval of other products may help, or Homeland Security could declare saline to be “part of the essential infrastructure,” requiring manufacturers to develop “business continuity plans… [which] would be costly & time consuming.” One alternative already taking place is importation from countries such as Brazil, bypassing the US distributors altogether and importing experimental medical devices from Europe that use less saline to accomplish similar tasks. “Supplies may need to be reserved for the sickest patients, and providers require an ethical framework for rationing products, while pharmacy staff closely monitor inventory.”

    • Actually, Michael S., all three U.S. IV Solutions manufacturers were cited in succession. First Hospira, which recently sold its IV division to ICU Medical (and its injectable drug division to Pfizer), then Baxter before the Hurricane, and then B. Braun Medical. ICU Medical is the only one that has recovered fully, but it has been forced into allocating its production to its longstanding existing customers only, or they wouldn’t even be able to service their current customer’s needs. However, Baxter always was and remains the largest of the three because they make close to 85% of the small volume “piggyback” bags used for antibiotics and premeds.

      I would only say that it is doubtless due to the fact that the impact wasn’t felt by the general public (they having no idea what is going on) that the FDA wasn’t forced to act quickly in allowing imported supplies from other countries. They allowed it, for example, for a time when Baxter was shut down prior to the hurricane, but then they stopped the import approval until just recently, even though supplies have been, and continue to be, extremely tight for three years and running.

      I understand the FDA’s need to be watchful of product safety, but how long does it take – especially when they allowed the imports previously and had, presumably, already vetted the overseas manufacturers (Baxter/Brazil and B. Braun/ Europe)? I have to wonder whether it would have taken them so long if this were a highly visible consumer OTC drug like Aspirin, Acetaminophen, Ibuprofen, or the antacids.

      The same can be said of Fentanyl and other pain drugs used in surgery that are currently on constant rolling back-order. The public doesn’t care because they don’t know, and so the FDA is slow to act.

      I do agree, though. We live in a free country, and no manufacturer can be forced to produce anything. I don’t know what the answer is, or should be. I only know its a real mess and has been for years now. A manufacturer can choose to produce a cheap, high volume generic drug like Fentanyl or Lidococaine that sells for $2.00 (or less) a dose, or they can invest in another drug that sells for $1,000.00 or more per dose, albeit with fewer doses sold. If the FDA comes in and says they need to spend $30 million to upgrade their generic drug plant, many are choosing to shut it down and invest in something more profitable.

      • Michael Bauman says

        My first real job out of high school in 1966 was working in the Central Service department of a local hospital. I earned $1.55 an hour. My main job was running the autoclaves (anybody remember them?). One of the main things I did was the sterile saline and sterile water solutions. They were in glass bottles of different sizes that had replaceable rubber tops that would seal the bottles after the autoclave session and allowed needle penetration. For the saline solution I had salt pills that I put into the water before sterilization. The surgery paks were also an important part of my job (no disposables). I had to follow specific protocols for filling, labeling and time in the autoclave plus a specific cool down period. I also got to sing while I worked and my fellow workers encouraged me to do so. Mostly Broadway Show Tunes.

        We never had a shortage. Supplies started running low, we made it a priority. We had assigned quotas for each shift. The time involved usually meant a shift could run no more than one rack of water though. Part of the problem seems to be centralization. Sometimes technology complicates things.

      • Gail Sheppard says

        They will invest in these newer drugs and there will be something wrong with them because the FDA fast-tracked them into the marketplace in a knee-jerk reaction to the overinflated hype on opiates. It will bring me no pleasure to me to say I told you so, but at least I’ll know I didn’t belong to the camp who promoted these expensive newcomers, over the cost-effective, tried and true drugs we’ve had for decades. Nor will I be the one with egg on my face when it becomes known (and it will) that all of this was to expand the revenue base of the “professionals” who made the prudent (for them) decision to redefine the term “addiction” to include the consumption of any drug associated with withdrawal. In one fell swoop, they created a whole new population of “addicts,” justifying the expensive new outpatient departments, rehab centers, and behavioral health groups we see popping up all over the place so they can track and treat those of us who are taking (or have taken) opiates, but who are not now, never have been or likely ever will be overtaken by them.

        • M. Stankovich says

          First I will say to you simply this: I stand by my personal training, qualification, expertise, experience, and most importantly, integrity. You are foolishly & arroganantly casting me among some league of vague “professionals” you read about in some book, and feel qualified & competent to challenge me with no factual basis. I would have been laughed out of my department with a similar level of “evidence.”

          Secondly, you obviously know nothing about the already clearly defined diagnostic criteria; ignore the distinction I have already provided between addiction & dependency; know nothing about the process or provision of treatment; or the fact that in the current philosophy of chemical dependency, the “chemical” to which one is dependent – be it an opiate or otherwise – is insignificant in regard to treatment, which should have been obvious from my description of dependence. And just this week, the FDA approved the first non-opiate medication for detoxification for opiate withdrawal. The bottom-line is that you have considerable opinions regarding the nature and goals to treatment, while factually knowing nothing about treatment, nor, apparently, ever having familiarized yourself with the basic concepts or extended yourself to living human being pushing air. It tends to give a poignancy to the whole matter.

          Finally, I am hardly concerned with getting “egg on my face” for the simple reason that my first and primary goal, above all else, is not to impress this, or any forum, with my “knowledge” of the issue(s), but to provide patient care in the most ethical, dedicated, and expert manner pursuant to my traning and expertise. That’s what they deserve, and that is my commitment. To suggest my commitment – and the commitment of the dedicated “professionals” with whom I chose to align myself is any less than I describe is unfounded, malicious, and certainly shortsighted, regardless of the “book” from which you have drawn you “expertise,” something into which I personally cannot imagine extending myself. And to suggest it is founded in profiteering is as offensive as it is idiotic. You mock the wrong guy. You don’t have any real point to make here because it doesn’t actually affect you. I suspect you didn’t like being corrected and I’m being asked to pay for it. Again, I stand by integrity.

  13. cynthia curran says

    Well, Pot is more likely to be legalized than the other drugs, Opium is an old drug, William Wilberforce used opium as a pain killer, In the 19th century there was hardly any drug regulation and opium use was probably worst then than now, Opium wars and opium dens,