The news release reports on the development of a new “mechanism of action” in the antibiotic vancomycin. However, while the release tells readers that vancomycin now has “new superpowers,” which “could eliminate the threat of antibiotic-resistant infections for years to come,” the new form of vancomycin has yet to be tested in an animal model — much less gone through the clinical trials in humans that would be necessary to determine how viable the new form may be in treating patients on any kind of widespread basis.
The release also says that “bacteria are only now developing resistance” to vancomycin — which is misleading. Vancomycin-resistant bacteria were first reported in 1987, 30 years ago — and papers (like this one) on how to limit the spread of vancomycin resistance date back more than 20 years. Is the new work interesting? Absolutely. But it is much too early to bandy about the kind of language used here.
The rise of antibiotic resistance in bacterial pathogens is a huge problem. As the 2015 paper, “The Antibiotic Resistance Crisis,” states: “The rapid emergence of resistant bacteria is occurring worldwide, endangering the efficacy of antibiotics, which have transformed medicine and saved millions of lives. Many decades after the first patients were treated with antibiotics, bacterial infections have again become a threat.” And that’s not an overstatement. The paper goes on to note that antibiotic-resistant strains of MRSA bacteria alone “kill more Americans each year than HIV/AIDS, Parkinson’s disease, emphysema, and homicide combined.”
In other words, developments regarding new antibiotics that work against bacterial infections are certainly newsworthy. They do not, however, benefit from being over-hyped. The advance discussed in this news release is interesting and newsworthy, but it is several steps removed from clinical relevance — and that is far from clear in the news release.
Cost is not addressed at all, likely because so much work remains to be done before the modified vancomycin is clinically relevant. However, if it’s not too early to talk about the clinical relevance of the findings (which the release does), then it is not too early to talk about potential cost — at least in broad terms.
Given that producing the modified vancomycin currently involves a 30-step process (which researchers are hoping to streamline), the cost may be considerable. The release goes so far as to say that “the new vancomycin’s lifesaving powers make its production valuable.” If they’re willing to say that, it would have been worthwhile to discuss, in a sentence or two, whether this new version of vancomycin may be more expensive than existing antibiotics. At any rate, cost should not have been overlooked completely.
The release tells readers that “Combined with the previous modifications, this [new] alteration gives vancomycin a 1,000-fold increase in activity, meaning doctors would need to use less of the antibiotic to fight infection.” It’s not entirely clear what this means. Does it kill relevant bacteria more quickly? More efficiently? Clinical trials in humans haven’t been conducted, so it’s not clear what the benefits would look like in patients — and the release doesn’t tell readers that.
As the final sentence in the abstract of the scientific article states: “Such antibiotics are expected to display durable antimicrobial activity not prone to rapidly acquired clinical resistance.” No where could we find quantifiable benefits of the drug in fighting antibiotic-resistant infection.
As noted above, the modified vancomycin hasn’t been tested in human trials. As such, it’s not clear what the potential harms may be. The release doesn’t mention this. And there will almost certainly be potential harms, given that conventional vancomycin has a range of potential side effects, from nausea and diarrhea to kidney damage. Could risk of these potential harms decrease if the modified vancomycin can be used in smaller doses to address bacterial infection? If so, that’s something the release could have addressed.
We also understand that some side effects would we a trade-off people might be willing to accept if it turns out the drug could prevent death or painful treatments that can come with an overwhelming bacterial infection.
The release tells readers only that the new form of vancomycin was tested against both vancomycin-resistant Enterococci bacteria and Enterococci that are not resistant to the drug. Was the study done using an in vitro model? In vivo testing in an animal model? How large was the n, or sample size? Based on the paper, the modified vancomycin was tested solely in an in vitro model. That would be useful context to provide for readers.
The drug needs to be tested in humans before it’s approved and judged to be of clinical relevance.
No disease mongering here. The release provides some useful context about vancomycin’s 60-year run as an antibiotic.
The funding source is clearly identified, and there does not appear to be a conflict of interest for the researchers. The release would have been stronger if it had clearly stated that there was no conflict of interest.
The release doesn’t discuss the other areas of research into developing new drugs that may be useful in addressing antibiotic resistance — and it’s a large field. We would not expect a news release to provide an exhaustive overview of other approaches being taken, but providing a sentence or two about other approaches would be extremely valuable in helping readers to place the new work in context.
The release says that “The next step in this research is to design a way to synthesize the modified vancomycin using fewer steps in the lab, as the current method takes 30 steps. But [lead researcher Dale] Boger calls this the ‘easy part’ of the project, compared with the challenge of designing the molecule in the first place.” Readers could be forgiven for thinking that this modified antibiotic could be in pharmacies by Christmas. But a lot of work remains to be done, in terms of both additional studies on safety and efficacy and (presumably) finding pharmaceutical industry partners who want to help this discovery move beyond the lab bench. We say presumably, because the release doesn’t address either of these hurdles.
The release doesn’t offer much in the way of specific details, but does make clear that this provides an additional mechanism of action for vancomycin. Presumably it is a mechanism of action not found in other drugs, which is what makes it more valuable in addressing antibiotic resistance, but that is not clear.
When saying that research has given a drug “new superpowers,” one expects to find robust and overwhelming data that demonstrates the efficacy of the relevant drug in a clinical setting. That is not the case here. And, frankly, it is difficult to think of a context in which a drug could be accurately described as “magical.” The language is over the top, particularly for a modified drug — even a promising one — that is this far removed from clinical use.
The news release reports on the development of a new “mechanism of action” in the antibiotic vancomycin. However, while the release tells readers that vancomycin now has “new superpowers,” which “could eliminate the threat of antibiotic-resistant infections for years to come,” the new form of vancomycin has yet to be tested in an animal model — much less gone through the clinical trials in humans that would be necessary to determine how viable the new form may be in treating patients on any kind of widespread basis.
The release also says that “bacteria are only now developing resistance” to vancomycin — which is misleading. Vancomycin-resistant bacteria were first reported in 1987, 30 years ago — and papers (like this one) on how to limit the spread of vancomycin resistance date back more than 20 years. Is the new work interesting? Absolutely. But it is much too early to bandy about the kind of language used here.
The rise of antibiotic resistance in bacterial pathogens is a huge problem. As the 2015 paper, “The Antibiotic Resistance Crisis,” states: “The rapid emergence of resistant bacteria is occurring worldwide, endangering the efficacy of antibiotics, which have transformed medicine and saved millions of lives. Many decades after the first patients were treated with antibiotics, bacterial infections have again become a threat.” And that’s not an overstatement. The paper goes on to note that antibiotic-resistant strains of MRSA bacteria alone “kill more Americans each year than HIV/AIDS, Parkinson’s disease, emphysema, and homicide combined.”
In other words, developments regarding new antibiotics that work against bacterial infections are certainly newsworthy. They do not, however, benefit from being over-hyped. The advance discussed in this news release is interesting and newsworthy, but it is several steps removed from clinical relevance — and that is far from clear in the news release.
Cost is not addressed at all, likely because so much work remains to be done before the modified vancomycin is clinically relevant. However, if it’s not too early to talk about the clinical relevance of the findings (which the release does), then it is not too early to talk about potential cost — at least in broad terms.
Given that producing the modified vancomycin currently involves a 30-step process (which researchers are hoping to streamline), the cost may be considerable. The release goes so far as to say that “the new vancomycin’s lifesaving powers make its production valuable.” If they’re willing to say that, it would have been worthwhile to discuss, in a sentence or two, whether this new version of vancomycin may be more expensive than existing antibiotics. At any rate, cost should not have been overlooked completely.
The release tells readers that “Combined with the previous modifications, this [new] alteration gives vancomycin a 1,000-fold increase in activity, meaning doctors would need to use less of the antibiotic to fight infection.” It’s not entirely clear what this means. Does it kill relevant bacteria more quickly? More efficiently? Clinical trials in humans haven’t been conducted, so it’s not clear what the benefits would look like in patients — and the release doesn’t tell readers that.
As the final sentence in the abstract of the scientific article states: “Such antibiotics are expected to display durable antimicrobial activity not prone to rapidly acquired clinical resistance.” No where could we find quantifiable benefits of the drug in fighting antibiotic-resistant infection.
As noted above, the modified vancomycin hasn’t been tested in human trials. As such, it’s not clear what the potential harms may be. The release doesn’t mention this. And there will almost certainly be potential harms, given that conventional vancomycin has a range of potential side effects, from nausea and diarrhea to kidney damage. Could risk of these potential harms decrease if the modified vancomycin can be used in smaller doses to address bacterial infection? If so, that’s something the release could have addressed.
We also understand that some side effects would we a trade-off people might be willing to accept if it turns out the drug could prevent death or painful treatments that can come with an overwhelming bacterial infection.
The release tells readers only that the new form of vancomycin was tested against both vancomycin-resistant Enterococci bacteria and Enterococci that are not resistant to the drug. Was the study done using an in vitro model? In vivo testing in an animal model? How large was the n, or sample size? Based on the paper, the modified vancomycin was tested solely in an in vitro model. That would be useful context to provide for readers.
The drug needs to be tested in humans before it’s approved and judged to be of clinical relevance.
No disease mongering here. The release provides some useful context about vancomycin’s 60-year run as an antibiotic.
The funding source is clearly identified, and there does not appear to be a conflict of interest for the researchers. The release would have been stronger if it had clearly stated that there was no conflict of interest.
The release doesn’t discuss the other areas of research into developing new drugs that may be useful in addressing antibiotic resistance — and it’s a large field. We would not expect a news release to provide an exhaustive overview of other approaches being taken, but providing a sentence or two about other approaches would be extremely valuable in helping readers to place the new work in context.
The release says that “The next step in this research is to design a way to synthesize the modified vancomycin using fewer steps in the lab, as the current method takes 30 steps. But [lead researcher Dale] Boger calls this the ‘easy part’ of the project, compared with the challenge of designing the molecule in the first place.” Readers could be forgiven for thinking that this modified antibiotic could be in pharmacies by Christmas. But a lot of work remains to be done, in terms of both additional studies on safety and efficacy and (presumably) finding pharmaceutical industry partners who want to help this discovery move beyond the lab bench. We say presumably, because the release doesn’t address either of these hurdles.
The release doesn’t offer much in the way of specific details, but does make clear that this provides an additional mechanism of action for vancomycin. Presumably it is a mechanism of action not found in other drugs, which is what makes it more valuable in addressing antibiotic resistance, but that is not clear.
When saying that research has given a drug “new superpowers,” one expects to find robust and overwhelming data that demonstrates the efficacy of the relevant drug in a clinical setting. That is not the case here. And, frankly, it is difficult to think of a context in which a drug could be accurately described as “magical.” The language is over the top, particularly for a modified drug — even a promising one — that is this far removed from clinical use.
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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