It would have been helpful if the story had pursued the question about out how long it typically takes a lab discovery of this nature to go to market as an available treatment (if it proves effective in humans). Instead, a mouse study that was inadequately explained was headlined as if the “drug may help people.”
We wish that the story had quantified some of the benefits and side effects and that it had brought in some outside perspectives, which might have toned down the comment about “at only twice the right dose (lithium) could kill a patient.” Also, adverse effects aren’t the only reason patients stop lithium. Many stop because they enjoy the mania and don’t like the so-called “neutral” mood (absence of a depressive or manic cycle).
Early stage research can be tricky for reporters. There can appear to be a lot of promise in laboratory studies that quickly disappears when the drug is tested in humans. Stories should signal clearly — and repeatedly — that there are many steps to the process and that a drug can even make it all the way through the approval process and end up shelved.
We do need better treatments for bipolar disorder and early lab-based discoveries need to be reported with care.
We couldn’t find good cost information for this drug. It hasn’t been on the market, for one, and the company that once had the patent on the drug is now out of business, so there are no good company filings that might shed light.
The story misses the mark in two main areas. No benefits are quantified, and no risks are quantified. Readers are only told “mice…were able to be calmed again with ebselen….In mice ebselen works like lithium.” Even if the technical explanation for how the mice improved in the study is difficult to explain to a general audience, we think readers deserve some hard data here. All mice were calmed? Half the mice? How many mice were made manic? How big was the experiment? Over what period of time.
At a very high level, it is troubling to see a study in mice headlined as “Experimental drug may help people.” It may just as readily be found NOT to help people.
The story focuses on the side effects from lithium, saying, for example, “But it is very toxic – at only twice the right dose it could kill a patient, Churchill said – and its adverse side-effects mean many people stop taking the drug and relapse into episodes of mania and depression.” We’d rather have hard data – e.g., if 100 or 1,000 people with bipolar disorder took lithium for five years, how many would be expected to die from lithium toxicity?”
We would have liked to have seen some side effect information for ebselen. Instead, the story states that the drug “may be a swift answer…since it is already known to be safe.” Data, please?
The story explains how the study was conducted. As noted before, it says right in the lead that the study was in mice. It also shows what the study compared. The mice didn’t have bipolar disorder, for example. Instead, “mice who were made manic with small doses of amphetamines were able to be calmed again with ebselen.”
But there wasn’t one comment about how good the mouse model is for understanding drug effects in humans with bipolar disorder. That’s a pretty important detail before a headline is allowed to trumpet that the drug “may help people.” How does one make that leap when the human trials haven’t been done?
There is no disease mongering in this story. In fact, the story provides this summary of the disease. “Bipolar disorder effects around 1 percent of the population worldwide and sufferers can experience moods that swing from one extreme to another, and have periods of depression and mania lasting several weeks or longer. These high and low phases are often so extreme they interfere with everyday life and work.”
The story would have benefited from some independent perspective. The two quoted sources are both researchers involved in the study. This was a story for which independent perspective was sorely needed.
The story describes lithium as the dominant treatment for bipolar disorder. “Some 60 years after it was first discovered, lithium – a mood stabiliser that can protect against both depression and mania, and reduce the risk of suicide – remains the most effective long-term treatment.”
The story explains that the drug is not available by noting, “Ebselen is an antioxidant originally developed up to late stage, or phase III, clinical trials by the Japanese firm Daiichi Sankyo for the treatment of stroke, but which never reached market and is now out of patent.”
About the only claim of novelty is the statement that “This is one of the first handful of examples of drug repurposing, where a new use has been found for an existing drug.” Interesting approach.
It does not appear that the story relied on a press release.