In an African health clinic, 18 patients who did not respond to conventional malaria therapy received tablets made from dried leaves artemisia annua (DLA). The patients, who were described as near death, all recovered according to a case report from Worcester Polytechnic Institute.
The news release on this case series is short on typical medical measurements, and we wish it had included details on how long the patients were followed. Did their “cures” remain for months or years? We also wonder if there is any financial benefit to the university or researchers if the new therapy were adopted. The release does not explain.
Finding a low-cost way to truly cure patients with malaria would be a stunning development that could save 429,000 deaths per year worldwide, according to the World Health Organization estimates. But this single report from a clinic about 18 patients is not enough to trumpet a cure, and we wish the release had taken more care to provide additional caveats. If this drug is used as the first line treatment, it is very likely that the parasite would eventually become resistant to the drug.
The release mentions this would be an “inexpensive treatment option” and goes into some detail about the economics of the region where the drug was tested and the advantage of a low cost therapy.
“Another advantage of DLA over conventional malaria treatments is its low cost and the relative simplicity of its manufacture, Weathers said. While the processes for manufacturing ACT is costlier and requires a higher degree of expertise, producing DLA tablets can be accomplished with simpler equipment and a modest amount of training. Growing Artemisia annua and producing and testing the tablets, Weathers noted, are ideal local business that can provide jobs in impoverished areas and greatly expand access to antimalarial therapy.”
Normally we like to see specific costs but in this case, an attempt is made to discuss the challenges and opportunities of developing a low cost therapy which seems appropriate here.
The story poses a hopeful scenario, but does not back up the claim of “cure” with the kind of numbers or measurements that we usually expect to cement the credibility of the evidence.
Here’s what the story says about 18 patients.
“After five days of treatment with tablets made from only the dried and powered leaves of Artemisia (which has been prepared and analyzed using methods developed by Weathers and postdoctoral fellow Melissa Towler), all 18 patients fully recovered. Laboratory tests showed they had no parasites remaining in their blood. (Weathers noted more than 100 other drug-resistant patients also have been successfully treated with DLA tablets.)
These 18 patients were dying,” Weathers said. “So to see 100 percent recover, even the child who had lapsed into a coma, was just amazing. It’s a small study, but the results are powerful.”
So the information provided suggests a strong likelihood of success. However, the release contradicts itself in a single paragraph. While it says more comprehensive clinical trials are warranted, in the very next sentence it states that the drug should be “rapidly incorporated” in areas with drug-resistant malaria.
We also aren’t told which test or tests were used to determine the absence of the malarial parasites and how sensitive they are. As testing technology advances, researchers are aware that it’s possible for malaria parasites to be present but undetected using current standard tests. A word of caution about the potential to miss these “hidden parasites” would have been helpful. In addition, another research institution states on its website that when artemisia annua has been used to treat malaria “recurrence is more likely than with conventional antimalarial treatment.”
We expect releases to state “there are no known harms” if that is the case, but this story does not mention potential harms at all. The story speculates that the stronger value of the dried-leaf product may come from other phytochemicals (not named) that are in the leaves. What if one or more of those have other impacts on patients months from now? Just because a drug is “natural” doesn’t mean it is free of side effects.
Memorial Sloan Kettering has studied artemisia annua and states that people taking antiseizure medications should avoid artemisia since it can induce seizures and make these medications less effective.
The release does a decent job explaining the study protocol. Since this is a study of patients who were likely to die without the treatment, this could be considered good evidence. However, the report focused on just 18 cases but the researchers mentioned they’d used this drug in 100 other patients as well. The response to the drug from those patients was not documented, suggesting there may be some serious side effects or other limitations with the study.
There was no disease mongering. The context provided about treatment-resistant malaria was helpful.
The release is wise to tell us that author Weathers is herself part of a project by the Polytechnic Institute to create processing techniques for the plant under study. But we are confused about patents held by Weathers and some of the other authors. Is there any profit possible for the authors, or WPI, if widespread use of the tablets was to begin?
If there is no conflict, the release could have said “The authors, while they hold patents related to the plant, do not have any potential profits or conflict of interest.”
The release states all patients had previously received artemisinin-based combination therapy (ACT), followed by intravenously administered artesunate, a medication for severe malaria, but did not respond to either.
The study is perhaps different than most because these patients had exhausted other therapies available to them and received this new therapy under experimental “compassionate use” rules.
These tablets are only available as part of experimental compassionate use. We think the release makes it clear they aren’t widely available.
The release quotes the researchers as saying they are the first to study and report on administering these dried leaves in tablet form. It explains that one of the ingredients in the plant is already a component of a drug administered to patients, but the dried leaves seem to hold extra potency.
The release uses the word “cure” in the headline and text without giving clear evidence that this is a universal cure for drug-resistant malaria. The release doesn’t tell us how long patients were followed after treatment, and we don’t know if they relapsed months or years later.