New antibiotics are desperately needed, but an advance in the synthesis of a new antibiotic should not be called a breakthrough when the drug has yet to be tested in people. This release fails to tell readers that all the claims are based on only laboratory tests. There is little acknowledgment of the uncertainties and challenges ahead. This research report is of great interest to drug researchers, but its relevance to practicing clinicians and the general public is not yet known.
Only a fraction of a percent of experimental drugs that produce positive laboratory test results survive the hurdles of animal and human testing. Especially when the need is so great, as is the case with antibiotic resistant infections, news releases should not proclaim success prematurely.
A key point of the release is that the researchers have developed a form of the teixobactin antibiotic that could be commercially viable. This statement implies that they made some rough calculations of the potential cost of manufacturing the drug. Even though it may be too early to guess at a market price (which depends on many factors other than actual manufacturing cost), it would have been nice to see some comparison to the production costs of other antibiotics.
The release says the simplified versions of teixobactin “have identical potency” to the natural form. A quote also claims teixobactin “kills bacteria without detectable resistance including superbugs such as MRSA.” But nowhere are readers told that teixobactin has yet to be tested in people. All the claims of benefits are based on laboratory tests. Readers should be told that the benefits for patients have not yet been tested.
As one commentary about new antibiotics published last spring noted, “Resistance development may not have been observed in initial experiments yet, but similar beliefs for e.g. vancomycin, have been proven wrong. As of yet, teixobactin has not yet reached testing in clinical trials.”
The release does not address potential harms. This omission is another reason the release should have made clear that although the researchers performed some laboratory tests for potential toxicity, teixobactin has not been tested in people, so its potential adverse effects are not known.
By neglecting to tell readers that the claims (which were not backed up by any numbers) are based entirely on laboratory tests, not tests in people with infections, the release may mislead many readers. The current evidence appears to be limited to in vitro studies in which the antibiotics were put into a test tube with the bacteria.
There is no doubt that antibiotic resistant infections are a widespread and growing threat. However, it is premature to claim that teixobactin is an answer to that threat when it has yet to be tested in people. This release dangles hope in front of millions of potential patients without the evidence to justify the claim that this drug will in fact help curtail antibiotic resistant infections.
The release does not discuss either funding or conflicts of interest. Readers would have to go to the journal article to learn:
Since other researchers investigating teixobactin have submitted patent applications and commercialization of basic research has become a routine part of academic science, it would have been nice to see this news release directly address the potential financial interest the researchers may have in the development of their work.
It appears that the release compares teixobactin to existing antibiotics, but it does not tell readers that the comparison is laboratory studies versus real world experience, which is not a fair comparison.
The release states that this work is a step closer toward creating drug treatments. There are no claims about how long subsequent testing and development may take. However, the failure to point out that this work is confined to laboratory tests and that human clinical trials have yet to begin implies a shorter path to potential clinical use than seems likely.
The release states that the researchers created versions of the teixobactin antibiotic that can be produced far more quickly and efficiently than the natural form. It also notes that this announcement builds on research done over the past 18 months.
The news release writers call this work a “breakthrough.” That’s what they also said in a release about an earlier research report from the researchers last June. Release writers were a bit more measured in a release issued in January, calling a research report from the team a “significant step.”
New antibiotics are desperately needed, but an advance in the synthesis of a new antibiotic should not be called a breakthrough when the drug has yet to be tested in people. This release neglects to tell readers that all the claims are based on only laboratory tests. There is little acknowledgment of the uncertainties and challenges ahead. This research report is of great interest to drug researchers, but its relevance to practicing clinicians and the general public is not yet known.
Only a fraction of a percent of experimental drugs that produce positive laboratory test results survive the hurdles of animal and human testing. Especially when the need is so great, as is the case with antibiotic resistant infections, news releases should not proclaim success prematurely.
A key point of the release is that the researchers have developed a form of the teixobactin antibiotic that could be commercially viable. This statement implies that they made some rough calculations of the potential cost of manufacturing the drug. Even though it may be too early to guess at a market price (which depends on many factors other than actual manufacturing cost), it would have been nice to see some comparison to the production costs of other antibiotics.
The release says the simplified versions of teixobactin “have identical potency” to the natural form. A quote also claims teixobactin “kills bacteria without detectable resistance including superbugs such as MRSA.” But nowhere are readers told that teixobactin has yet to be tested in people. All the claims of benefits are based on laboratory tests. Readers should be told that the benefits for patients have not yet been tested.
As one commentary about new antibiotics published last spring noted, “Resistance development may not have been observed in initial experiments yet, but similar beliefs for e.g. vancomycin, have been proven wrong. As of yet, teixobactin has not yet reached testing in clinical trials.”
The release does not address potential harms. This omission is another reason the release should have made clear that although the researchers performed some laboratory tests for potential toxicity, teixobactin has not been tested in people, so its potential adverse effects are not known.
By neglecting to tell readers that the claims (which were not backed up by any numbers) are based entirely on laboratory tests, not tests in people with infections, the release may mislead many readers. The current evidence appears to be limited to in vitro studies in which the antibiotics were put into a test tube with the bacteria.
The release doesn’t disease monger. There is no doubt that antibiotic resistant infections are a widespread and growing threat.
The release does not discuss either funding or conflicts of interest. Readers would have to go to the journal article to learn:
Since other researchers investigating teixobactin have submitted patent applications and commercialization of basic research has become a routine part of academic science, it would have been nice to see this news release directly address the potential financial interest the researchers may have in the development of their work.
It appears that the release compares teixobactin to existing antibiotics, but it does not tell readers that the comparison is laboratory studies versus real world experience, which is not a fair comparison.
The release states that this work is a step closer toward creating drug treatments. There are no claims about how long subsequent testing and development may take. However, the failure to point out that this work is confined to laboratory tests and that human clinical trials have yet to begin implies a shorter path to potential clinical use than seems likely.
The release states that the researchers created versions of the teixobactin antibiotic that can be produced far more quickly and efficiently than the natural form. It also notes that this announcement builds on research done over the past 18 months.
The news release writers call this work a “breakthrough.” That’s what they also said in a release about an earlier research report from the researchers last June. Release writers were a bit more measured in a release issued in January, calling a research report from the team a “significant step.”
Systematic, Criteria-Driven
Excelente conversación entre @garyschwitzer de @HealthNewsRevu y @marynmck sobre exageración y #COVID19 en el excelente MOOC de @utknightcenter. Vale la pena verlo. https://www.youtube.com/watch?v=SkgXiPojtg4&feature=youtu.be
Words of real wisdom, as usual @garyschwitzer
And: “There were no details, charts, graphs, numbers, nothing published in a journal."
#Pharma chairman:“If you don’t put out data people will say why are you withholding the data?”
Well, yes, that is exactly what people are asking. https://twitter.com/garyschwitzer/status/1264572399523180548
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