To begin with, the headline of this story is a little much: a “side-effect free future” with this patch? Surely, we can’t dispense entirely with oral ibuprofen even if this patch were to deliver everything it promises. And while it makes sense that transdermal delivery would reduce stomach-related side effects, do we really know if this approach will eliminate other possible side effects that aren’t related to the GI tract — for example related to cardiovascular risk? The advantages of the TEPI patch (this apparent acronym is never spelled out in the story) over existing products on the market sound impressive and believable — although very little evidence is given to help us assess the quality of these claims.
The promise of transdermal drug delivery has been on the horizon for decades and the TEPI patch is the latest iteration. Ibuprofen and the other NSAID’s are safe and effective for the vast majority of people taking them. People with chronic conditions like osteoarthritis are at risk for side effects because of the relatively large doses taken orally. In theory, a patch could reduce the likelihood of these side effects but the proof is simply not there yet.
We’ll rate this N/A since the patches are still in development for the consumer market. Having said that, we should point out that generic ibuprofen is very inexpensive. It is very likely that the TEPI system will cost the consumer much more.
The story is full of superlatives but provides absolutely no information on how the TEPI patches were tested. All of the information provided appears to be related to results in the lab and not on people. We are told, “…capable of releasing between five and ten times the amount of drugs used in gels and patches currently on the market, for periods of six hours, 12 hours, and even 24 hours.” How long do current gels and patches last? How much medication do they release? Is is important to be able to achieve the higher dosages discussed in this story? While it all sounds very impressive, the reader isn’t provided enough information to tell if any of these results are meaningful.
The story provides no information on the potential side effects of this method of drug delivery. Ibuprofen is a drug and all drugs have side effects. It sounds like the TEPI patches will have the same possible side effects as topical gels or other patches, which are mostly limited to irritation on the skin and other minor issues. It is claimed that the TEPI patches cause little discomfort, but how was this assessed?
It is not at all clear how the advantages of TEPI patches over current products on the market were established.
No independent sources were interviewed. The two sources that were interviewed for this article were both disclosed to be affiliated with the company Medherant, producer of the TEPI patches. Since the use of transdermal patches has been around for decades, it should have been relatively easy to identify experts in the field.
There was a decent amount of discussion about alternatives like ibuprofen administered orally or topically as a gel.
The story tells us the the patches are expected to hit the market in three years, but the information comes direct from the company and isn’t independently verified. Given the stage of development for this technology, three years sounds like a very aggressive timeline given the need for clinical validation of the assumptions made and the need for regulatory approval.
The story establishes what’s new about the patch compared with existing transdermal technologies, including that it might be applied to drugs that previously haven’t been suitable for this approach.
It’s clear that some original reporting was done in an interview, so the story does enough to clear our bar. That being said, the end result doesn’t seem to be much different than this December 2015 news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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