This story would not exist without the company news release. There was no conference where these results were released. There was no journal that published these results. The drug in question — an antibiotic called solithromycin — showed no clear benefits over existing drugs. Yet the story does not spell out for readers that this is as much marketing as it is science. We get that this story was meant for investors, but we found it in the health section of the Fox News website where it will be seen and shared by average readers. These readers deserve more than what this story delivered.
Multiple studies have shown a rise in antibiotic resistance as previously stalwart drugs have proven less and less effective over time. On the whole, the world has done a terrific job in lowering rates of infectious diseases, but the threat of bacteria that can overpower antibiotics — especially for older people and people with compromised immune systems — remains real. New classes of drugs have been tried with varying degrees of success, and so companies like Cempra are trying to bring drugs to market that they hope will prove more effective and ultimately become big sellers. Because the only reason the world needs new antibiotics is because the old ones aren’t working as well as they used to, it’s important even in an investor-focused story like this one to make it clear whether a drug has been shown to have more benefits and fewer risks than existing drugs.
There was no discussion of costs in this story, only the effects on company stock values. The drug is not yet on the market, but, given that similar drugs are already being sold, a range of prices could have been offered. No doubt the analyst quoted in the story could have helped provide some new-drug-pricing predictions.
If you read the story fast, you might think that the benefits are quantified. It talks about “the unparalleled rate” of “bioavailability,” meaning how quickly a patient’s blood absorbs the drug. But this is not a clear health benefit. It’s just part of the pathway on the way to a benefit. Ineffective drugs and even harmful drugs can absorb in the blood quickly or slowly. Does the drug actually control infections? Our primer on surrogates offers some great information about evaluating these indirect markers of treatment efficacy.
The story mentions that the drug has an “impressive safety profile” and calls out its “low degree of gastrointestinal toxicity,” and it alludes to other drugs that were “associated with liver toxicity” and “linked with heart risk.” It does not provide any numbers to back up the claim that the drug’s safety profile is better than existing drugs.
The story makes no mention of how many people were studied, where the study was published or who funded the study. It refers to the study as a “late-stage trial,” indicating that the drug must have passed through other trials and regulatory hoops to get to this point. If you read the press release about the study, you find out that the trial was a “double-blind, active-controlled global, multi-center trial that enrolled 860 adult patients with moderate to severe CAPB,” which stands for community-acquired bacterial pneumonia. You also find out that there are other trials underway. You find out that the trial was conducted by Cempra Inc., the company that makes the drug, and you find out — by omission — that the trial results were not published in any peer-reviewed journal.
The story does not point out that the trial was conducted by the company that makes the drug. It only quotes one source outside the company, and that’s a market analyst who has a stake in whether the company does well or poorly.
The story does make references to how the drug compares to other drugs on the market, but it does not present enough evidence to make fair comparisons. For example, it says that “Data showed solithromycin outperformed moxifloxacin by a slight margin.” This is misleading. The press release about the trial stated that the “early clinical response” — without explaining what that is — was 78.2% for solithromycin and 77.9% for moxifloxacin. If you round in both cases, you get 78%, and that would not be unreasonable because the press release stated that the rates could be as much as 5.5% lower or 6.1% higher, given the confidence interval. So, really, the story should have said the two drugs were statistically equivalent.
The story makes it clear that the drug is in the clinical trial phase.
The story makes it clear that Cempra is trying to enter a market with multiple, similar drugs.
It’s questionable whether this story merited publication based solely on an announcement by the drug company. That said, the story takes a very confusing, jargon-heavy press release and attempts to make sense of it. It doesn’t get all the way there, but the story provides more context than the press release and explains a little bit better why readers — whether they are potential patients or potential investors — should care about this drug.
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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