Opioids: Bad Science, Bad Policy, Bad Outcomes

Opioids: Bad Science, Bad Policy, Bad Outcomes – by Henry I. Miller and Josh Bloom – 2019

 As is so often the case nowadays, this article does not show what date it was published. This is clearly intended to confuse the reader about whether it’s a “current” article or from much older archives.

I can only estimate the date of publication by what other studies it references. In this case, it refers to a JAMA article from Feb 2019, so it must be later than that.

There’s an old joke about the drunk who’s hunting for his lost keys under the lamppost, not because he thinks they’re there, but because the light is good. Well, that’s what the feds and state governments are doing to try to quell the epidemic of opioid addiction and overdoses.   

The problem is quite real, but legislators and regulators are making incorrect assumptions and adopting flawed strategies.

This is due to all the current anti-opioid research bias and the distorted numbers published by the CDC, which includes overdoses counted multiple times for each drug found in the dead body. (See CDC Over-Counting Rx Opioid Overdose Deaths)

And then, there are some flawed clinical studies and statements by the U.S. surgeon general that conspire to create misunderstanding of the landscape. 

For a start, the problem isn’t currently prescribed opioids, such as fentanyl, morphine, oxycodone, and hydrocodone.

A study published earlier this year in the New England Journal of Medicine found that from 2012 to 2017, a time when the overdose death rate was markedly accelerating, the rate of opioid prescriptions in patients who had not previously used opioids fell 54%, a decline driven by a decreasing number of prescribers.

In spite of such findings indicating that the crux of the problem is not physician-prescribed opioids but illicit fentanyl and its analogs smuggled from abroad, like the drunk in the parable the feds and state governments are looking in the wrong place

The feds misunderstand the role of opioids in providing relief from significant pain — such as from kidney stones, sciatica, cancer, or broken bones, which can be excruciating — but they are not entirely to blame.

Academics have also contributed — for example, a 2017 article in JAMA Network by Chang et al.  The study is so poorly designed that we can only conclude that the investigators intended to get a desired, albeit inaccurate, result — namely, that acetaminophen (brand name: Tylenol) and ibuprofen (brand name: Advil) are as effective pain relievers as opioids alone or opioids in combination with acetaminophen.

If they were real, these findings would be hugely important, because opioids could be supplanted by widely used, over-the-counter analgesics. For that reason, it is worth enumerating the flaws — or, more precisely, tricks — in the study.

Indeed, let’s call these supposed “flaws” what they really are: tricks to make the results show opioids don’t work well.

The four groups that were compared:

  • Group 1 received 400 mg of ibuprofen plus 1,000 mg of acetaminophen
  • Group 2 received 5 mg of hydrocodone and 300 mg of acetaminophen
  • Group 3 received 5 mg of oxycodone plus 325 mg of acetaminophen
  • Group 4 received 30 mg of codeine and 325 mg of acetaminophen

There are several problems with the study design:

  1. Dose

It appears that the study was designed to compare the analgesic power of the highest permitted dose of ibuprofen and acetaminophen with the lowest effective doses of hydrocodone and oxycodone.

That’s not playing fair. If this trial had been performed with realistic, instead of barely therapeutic, opioid doses we would expect to see very different results.

  1. Selection criteria

If the patients had been experiencing really intense pain from, say, kidney stones or severe sciatica, ibuprofen and acetaminophen would hardly touch it.

  1. Opioids to the rescue — for some

Approximately 18% of the patients received “rescue analgesia.” In other words, when the initial treatment failed, the patient was given oxycodone or morphine.

  1. We wonder why those patients were given insufficient pain medicine in the first place

And we believe that the rescue data indicate that opioids are superior for pain relief.

The 73 did not get “rescue acetaminophen” because

a) some of them had already been given the maximum dose, and
b) literature reviews have shown that acetaminophen is pretty worthless as an analgesic.

We can’t help wondering why anyone in an emergency room with “moderate to severe acute extremity pain” would agree to be part of a study in which three-quarters of the patients weren’t going to receive an opioid.

We suspect that there’s not a compos mentis physician in the world who would volunteer to be a patient in such a study.

Does Tylenol relieve pain better than morphine? Count us as skeptical. Adams was referring to a 54-person randomized clinical trial of pain control following rib fractures, which are notoriously painful.

Basically, that study found that 30 minutes post-administration of drug, the mean pain score on a scale of 1-11 was

  • 5.5 for the morphine-treated patients and
  • 4.9 for the Tylenol-treated patients.

Here’s another trick: they used a different pain scale than the one that’s used by 99.9% of doctors. By adding another choice at the top of the scale, the results are skewed slightly higher.

That supposed difference was the entire basis for Adams’ claims of equivalence of Tylenol and morphine — except that the data aren’t even close to being statistically significant: p = 0.23. (Statistical significance would be p<0.05.) In plain language, one cannot conclude from this study that Tylenol is equivalent to morphine.

There were many other deficiencies in the design of the study. For example, there was no control group.

This is because all opioid studies these days have grossly flawed designs, meticulously devised to “prove” that opioids aren’t effective.

Perhaps more baffling about the study is that when there was a treatment failure after 30 minutes (inadequate pain relief), morphine was given as a rescue therapy.

This automatically skews the results. It’s like saying “Tylenol works as well as morphine except when it doesn’t.”

Nor do the authors tell us how often rescue therapy was given.

So, this significant outcome of a pain study did not count those that needed an opioid to finally ease their pain when OTC pills didn’t help.

This is exactly what’s happening in so many other studies, where any positive role of opioids is not recorded as part of the study, but carefully hidden. (see also Study finds opioids ARE effective for chronic pain)

Finally, there was this:

“Presentation of side effects was similar in both groups.”

That is hard to explain. We’ve been hearing for a decade how dangerous opiate analgesics are, but there was no difference in side effects between the Tylenol and morphine groups?

And, no “innocent” patients became addicted, which negates the PROPaganda about pain pills being “heroin pills” that cause instant addiction. (See also “Krebs Study” Shows Opioids are Safe)

This is something I see in most of the studies comparing opioids to whatever else the researcher is suggesting “works as well” as opioids. (See Studies Show Addiction NOT Induced by Opioids for Pain)

The fact that the patients who received morphine did not report nausea or dizziness suggests that morphine was either not used at all, or used at a sub-therapeutic dose.

The evidence continues to accumulate that the government’s opioid policies — and pronouncements — need adult supervision.  We are not optimistic that it will materialize.

Yet there has now been pushback from the CDC, FDA, several doctors, and medical groups:

Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology. Josh Bloom is the director of chemical and pharmaceutical science at the American Council on Science and Health. He has a Ph.D. in chemistry.
Issues & Insights is a new site formed by the seasoned journalists behind the legendary IBD Editorials page. We’re just getting started, and we’ll be adding new features as time permits. We’re doing this on a voluntary basis because we believe the nation needs the kind of cogent, rational, data-driven, fact-based commentary that we can provide. 

11 thoughts on “Opioids: Bad Science, Bad Policy, Bad Outcomes

  1. Kathy C

    We have had 22 years of lies, propaganda and misinformation. These deliberate “flawed” studies, get amplified by mass media, while factual analysis, is censored. For 22 years they have lied to the public and to patients. Even though the government was tracking every dose of opioids, and threatening physicians and patients, a decade ago, they ignored the supply chain, to protect the industry.

    These deliberately flawed and distorted “studies” are frequently used in marketing, and misinformation, yet they get amplified every day. It is no wonder that the general public questions science. Perhaps they justify this misinformation by claiming it has a public health message, such as opioids are not good. They are terrifying the general public, while keeping us all distracted.

    The so called opioid epidemic should have had us all questioning the role of money in politics, and the lack of a public health response back in 1996, instead we just get more marketing and misinformation. It is clear there are no scientific standards applied to any of this distorted science. This problem has been very profitable, for a few, and there is still money to make made spreading lies and misinformation.

    The fact remains that the regulatory agencies that were supposed to be protecting public health, were overrun by the industry. https://www.politico.com/story/2019/08/21/federal-scientists-opioid-crisis-1673694 They did not come out with a fact based public health response back then. Instead they allowed the industry to go unhindered and protected, while they attacked patients, and stigmatized the addicted. They denied medication to patients, to prevent heroin addiction. Even though it did not work, the death rate rose,along with the number of suicides, they continued on.

    It is no wonder Perdue, the maker of Oxycontin wants to suddenly settle, they want to protect the industry insiders who helped them. If they settle the facts won’t come out. They had a lot of help and they don’t want the general public to be aware of the deceptive marketing of more than just the opioids. They deregulated pharmaceutical marketing, and allowed a public health crisis to go unchecked. Only 2 nations allow pharmaceutical marketing, and here in the US they want to keep the public in the dark about the danger to public health.

    In the meantime, content marketers and hucksters, continue to peddle everything from marijuana to homeopathy, and mindset.. Lies and propaganda are profitable. They turned a public health problem into a marketing campaign, a profitable one,. The fact that people are dying because of the lies and misinformation, is being suppressed. We are in the land of Alternate Facts!

    Liked by 3 people

    Reply
  2. canarensis

    I think I already added this comment to another post, but am gonna do it again b/c it strikes me as going particularly straight to the heart of the “pain don’t need relieving” new paradigm. Sorry if I’m boringly (or annoyingly) repetitive. But I keep hoping that maybe some non-pain person will see it & go “Hey, that’s not a bad point. Maybe pain really is real & should be treated.”

    If pain is so not-a-big-deal that we’re just supposed to live with it (& it’s not hard, according to the anti-opioid zealots), why is it that pain is used in torture, has been for pretty much all of human history? If pain is no big deal, then neither is the rack or the Iron Maiden or pulling out fingernails or breaking fingers with pliers or whatever. Everyone who insists that pain is no big deal should be forced to spend several hours in a torture device, then tell us that pain is minor & easy to deal with. Or, since many of us have severe pain 24/7/365 that is supposed to be no big deal to live with, let ’em be locked in it forever.

    Liked by 2 people

    Reply
      1. canarensis

        Really. As we all prolly know, that’s the main reason there are basically no good clinical studies on the efficacy of opiate pain meds for chronic pain…they deemed it unethical to force folks to go without pain relief for longer than 3 months (IMO, even 3 months is unethical). But now it’s not only ethical but pretty much required –the moral thing to do!– that we go without pain relief forever, for propagandistic & greed “reasons.”

        But yeah, the control group for this…surgery w/o pain relief? God help us, that IS torture. Of course, nationwide the new policy of no opiate pain meds after surgery is institutionalized torture…all so the less than 1% of patients don’t get addicted. Sanity & sense are truly things of the past. As are mercy and compassion.

        Liked by 1 person

        Reply
  3. Kathy C

    This nation did endorse torture. One of the main torture doctors, came up with new ways to market it. https://www.newyorker.com/science/maria-konnikova/theory-psychology-justified-torture

    https://www.huffpost.com/entry/do-torture-shunning-shami_b_7188914 They even used Seligmans Ideas to justify underfunded schools and low income traumatized kids who did not have regular meals. They cliamed these kinds did not have “Grit.”

    https://www.economist.com/democracy-in-america/2015/07/28/how-americas-psychologists-ended-up-endorsing-torture

    https://www.psychologytoday.com/us/blog/the-fight-against-hate/201507/torture-apa-and-the-hoffman-report-what-now

    Not one pain psychologists has come out publicly stating that withholding pain medication is torture. They never stated that withholding medical care for people with painful conditions is r. They also stayed out of the addiction problem too, failing to explain that refusing addiction treatment, shaming and stigma may be torture or drive addiction. They wanted to increase the scope of their practice in all cases, from torture to addiction to pain. Not one ever considered the ethical issues with their marketing and misinformation.

    https://www.nybooks.com/articles/2016/04/21/learned-helplessness-torture-an-exchange/

    It looks like they monitor this page frequently to remove references to his torture program.
    https://en.wikipedia.org/wiki/Martin_Seligman

    Liked by 2 people

    Reply
    1. canarensis

      Lacked grit…God help us. Let’s bring back child sweatshop labor to toughen up the little weenies. Spare the rod & spoil the child –child abuse is good! Builds character. Toss out this lily-livered notion of getting rid of bullies & bullying –bullies are just the kind of youngster we need, not a bunch of 48 pound weaklings, & those weaklings might develop some grit if they get beat up enough.

      I can’t stand it. honestly.

      Liked by 2 people

      Reply
      1. Zyp Czyk Post author

        I was raised in the traditional German manner – my mother did what “they” said and didn’t hug me because it would make me a sissy. She trained, not taught, me and my brother and used only punishment because praise was inappropriate when we were just doing what we were “supposed” to.

        She and I were a terrible match: her demanding strictness and my ultra-sensitivity. Damage was done, but we’ve talked about it, cleared the air, and moved on.
        Nowadays, she doesn’t act anything like she used to – and neither do I.

        Liked by 1 person

        Reply

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