This article explores the mid-stage development of a vaccine to control high blood pressure. It has several serious flaws.
Readers are not well served by this article. It may unduly raise patient hopes about the value of vaccinations for chronic disease.
The article says the vaccine developers see them as "potential low-cost" products to control or prevent chronic disease. If this assertion is made in the article it should be explored or challenged. The initial choices for management of hypertension are a thiazide diuretic and a beta blocker. These drugs are pennies a day.
The article reports that three shots over 12 weeks reduced systolic pressure by 5.6 millimeters of mercury, diastolic pressure by 2.8 millimeters.
While it usefully says this is roughly equivalent to the drop produced by a drug in someone with mild hypertension, it fails to report the disease state of the experimental group, whether they had previously taken medication and other essential details. The effectiveness of the vaccine in the long run is unclear as is the ability of this approach to actually reduce events. We learned from the ALLHAT study that reducing blood pressure may not reduce cardiovascular risk. The vaccine is a long way off from demonstrating effectiveness in cardiovascular risk reduction.
The story mentions the potentials for harm, including the most important–that a vaccine can have unanticipated consequences that may prove impossible to reverse or even control. These concerns should have appeared higher and more prominently in the story, however.
The study cited is unpublished, funded and operated by the vaccine maker. It is a stage II trial. The reporter failed to emphasize these limitations.
The opening anecdote describes a man who has difficulty complying with his blood pressure medication regimen. But his circumstances are extraordinary: He needs to take 9 pills in the morning and 9 pills at night.
The anecdote exaggerates the difficulties of drug compliance–and casts an excessively positive light on the following discussion of antihypertension vaccines.
Further, the report says "studies show that only about half of people with high blood pressure follow doctors’ orders." It’s not clear what that means. Compliance rates, or success in maintaining targeted blood pressure levels, would be more meaningful statistics.
The article quotes the vaccine developer’s chief scientific officer, the lead researcher who works on behalf of the vaccine developer, one skeptic and one neutral observer who adds an inconsequential comment about the mechanism of morning hypertension.
The article would have been better if it had added comments from one or two independent experts, especially those who could talk about more conventional methods of controlling blood pressure.
Many people with hypertension–especially those with early stage or mild-to-moderate disease, who are considered by the company to be likely targets of this product–can be treated successfully with lifestyle changes. Others are successfully treated with fairly simple generic medications.
The report failed to mention that these nearly free, low-tech treatment options exist and are well documented to be effective–and call into question the need for and value of vaccines for this condition.
The article makes clear that the vaccine is still in development.
The article makes clear that the use of vaccines for chronic disease is a novel concept.
A press release issued by a company along with the November presentation at the American Heart Association meeting makes some of the same points as the story. So does the American Heart Association release itself. However, it’s not possible to determine whether the article drew excessively on the releases.
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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