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:
- The maximum therapeutic single dose of ibuprofen is 400 mg. (Doses higher than 400 mg have not been shown to be more effective.)
- The maximum recommended single dose of acetaminophen is 1,000 mg. Higher doses can cause irreversible liver damage.
- The usual adult dose of hydrocodone is 5-10 mg.
- The usual adult dose of oxycodone is 5-15 mg.
- The usual adult dose of codeine is 15-60 mg.
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.
- 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.
- 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.
- 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:
- CDC Issues Key Clarification on Guideline
- FDA Implies CDC Guidelines Are Not Evidence-Based
- FDA identifies harm from discontinuation of opioids
- Stanford Letter to Oregon Chronic Pain Task Force
- Pain Experts Call for End to Forced Opioid Tapering
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.
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