Dr. Aric Hausknecht Responds to SG Jerome Adams' Tylenol Recommendation

By Josh Bloom — July 12, 2019 @ American Council on Science and Health

#Special to ACSH.

ACSH friend Dr. Aric Hausknecht, a New York neurologist and pain management physician, has taken issue with the July 4th advice tweeted by Surgeon General Jerome Adams, M.D., which recommended the use of IV Tylenol for post-op pain.

Dr. Hausknecht gave us exclusive permission to print his response to Dr. Adams.

I am writing in response to recent comments made by the U.S. Surgeon General, Jerome Adams, regarding the use of intravenous acetaminophen for anesthesia and post-operative pain relief. The Surgeon General implies that acetaminophen (Tylenol) is equally efficacious to intravenous (IV) opioids for pain relief. Apparently, his comments are based upon, Comparison of the Analgesic Effect of Intravenous Acetaminophen and Morphine Sulfate in Rib Fracture; a Randomized Double-Blind Clinical Trial,  Emerg (Tehran). 2015 Summer; 3(3): 99–102. The authors of this paper concluded, "The findings of the present study showed that IV acetaminophen and morphine have the same therapeutic value in relieving the pain of rib fracture."

However, this study was carried out on a limited population group, 54 patients in total, and the statistical analysis is of questionable validity. At best, this study establishes a need for further inquiry, but in no way does this study provide adequate evidence to use IV acetaminophen as a substitute for IV opioids.

In another related paper, Intravenous versus Oral Acetaminophen for Pain: Systematic Review of Current Evidence to Support Clinical Decision-Making, Can J Hosp Pharm. 2015 May-Jun; 68(3): 238–247, the authors performed a literature review from 1948-2014 and "summarized and evaluated the available published literature describing efficacy, safety, and pharmacokinetic outcomes of randomized studies assessing oral versus IV dosage forms of acetaminophen." The authors concluded, "For patients who can take an oral dosage form, no clear indication exists for preferential prescribing of IV acetaminophen." On the basis of this comprehensive review, the authors concluded, "Therefore, on the basis of current evidence, if a patient has a functioning gastrointestinal tract and is able to take oral formulations, IV formulations (of acetaminophen) are not indicated."

Additionally, IV acetaminophen is FDA approved for use in the management of mild-to-moderate pain and moderate-to-severe pain with adjunctive opioid analgesics. It is not clear why a physician who is in a position to shape public policy would recommend  standards of care that suggest that IV acetaminophen is equally efficacious to IV opioids when: 1) that premise is unproven, 2) there is strong evidence that oral acetaminophen is equally efficacious to IV acetaminophen,  3) IV acetaminophen should probably not be administered to a patient that can tolerate oral administration, 4) IV acetaminophen is not FDA approved as a stand-alone analgesic agent for mild-to-moderate pain and moderate-to-severe pain, and, 5) it is contrary to good and accepted medical practice that has established that opioids are more efficacious than acetaminophen for postoperative pain and for moderate-severe pain.
I remain,

Aric Hausknecht, MD
Diplomate American Board of Psychiatry and Neurology
 

Tags: 

Tylenol

post-operative care

post-operative pain

opioid denial

 

And then to follow up

US Surgeon Gen. Backpedals on Flawed Tylenol Study. Cause of ACSH.
Dr. Jerome Adams celebrated Independence Day by trumpeting a study which concluded that Tylenol worked as well as morphine for controlling the pain from a broken rib. But the study was complete nonsense. ACSH caught the Surgeon General and now he's backpedaling like the woman in the bicycle scene from The Wizard of Oz (played backward of course)..............To Read More.....

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Need General Surgery? Ignore The Surgeon General

By Josh Bloom — July 8, 2019 @ American Council on Science and Health

Just what we don't need. Another anti-opioid (pro-pain) zealot spreading the false gospel. But we have one anyhow - US Surgeon General Jerome Adams, M.D.

On July 3rd Dr. Adams Tweeted the following:

Isn't that swell? Being obsessed over whether post-op patients do or don't need a few doses of opiate pain medication instead of focusing on the patient's individual needs? Since when did recovery from surgery become a contest?

"My patients can survive a knee replacement with only ibuprofen. They may scream a little, but eventually, they stop. Usually."

"Oh yeah? My patients don't even need general anesthesia for spinal fusion! We just strap 'em down, stick a couple of acupuncture needles at their ear and... voila! A titanium rod across four cervical vertebrae."

Sort of an analgesic version of "Name The Tune."

Adams' Tweet the next day was worse...

Wow! Tylenol works better than morphine. That must be one hell of a study.

It is - one hell of a terrible study. Here's why.

Adams was referring to a 54-person randomized clinical trial of pain control following rib fractures, which are notoriously painful. The trial, which was conducted in an emergency department Iran, compared IV Tylenol (1000 mg) and morphine (0.1 mg per kilo of body weight) (1). The result? Tylenol worked as well as IV morphine for relief of pain from rib fractures, that is until you bother to read the paper, which was published in the journal Emergency (Tehran). On the slight chance that you're not a subscriber, here's a summary.

• Thirty 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. These two numbers make up the "evidence" behind Dr. Adams' claims of equivalence of Tylenol and morphine. Except the data aren't even close to statistically significant - P = 0.23. No, Tylenol is not equivalent to morphine; there is no way to tell from this study. Its numbers are meaningless.

Even the authors seem to acknowledge this fact, assuming you can figure out what they're talking about:

The success rate reported for this drug in this study was 80% that although [sic] did not have significant difference with morphine (58.6%), it had more improvement rate, clinically. 

Huh?

ACSH advisor, biostatistician Dr. Stan Young had this to say.

The rage these days is to say OTC pain med is as good as morphine etc. Here the authors claim victory if there is no difference. "Proving equal" is a different game. You just have to worry about statistical power. Just run a small, underpowered study and you can easily get no difference (victory).

It gets worse...

• There was no control group, so we don't know if either group got relief from the medicine or the reduction in pain score was due to a placebo effect. 

The initial pain score of both groups was "the same" but with P = 0.19 this may or may not be true. The group that received the Tylenol could have come in with more pain, less pain, or no difference. We cannot tell from the data.

• The success rate (defined as a 3 point reduction in pain score) was 80% for Tylenol and 59% for morphine. That isn't significant either. P = 0.09. Even the authors acknowledge this:

"The success rate reported for this drug in this study was 80% that although did not have [sic] significant difference with morphine (58.6%), it had more improvement rate, clinically." 
Mehrdad Esmailian, et. al., Emerg (Tehran). 2015 Summer; 3(3): 99–102.

• 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 this happened. 

Finally, we have this:

"Presentation of side effects was similar in both groups."

Are they kidding? All we've been hearing for a decade is how dangerous opiate analgesics are and there was no difference in side effects between the Tylenol and morphine groups? Was there any morphine in the morphine, because I can't think of any other explanation for this.

This is what our Surgeon General used to "inform" us that IV Tylenol works as well as morphine - a 2015 paper in a journal with maybe two readers, which is filled with a whole lot of information, none of it valid.

What a joke.

NOTE

(1) A dose of 0.1 mg per kilo of body weight (7 mg for a 70 kg patient) is within guidelines for an initial dose of morphine.

Please Help Fund Our Work - If you follow our work, you know that we here at ACSH go after the fraudsters, the hucksters and the snake-oil peddlers. And when we're not debunking their misleading or dangerous junk science, we're always aiming to give you the most accurate and dependable health news. But we can only continue to do that with support from our readers and friends who value what we do. So if you can ... Please Donate. Thank you.