This Associated Press story highlights FDA approval of a new drug–the first medication approved specifically for treating tardive dyskinesia. A new drug that promises to alleviate a previously intractable movement disorder is good news. However, even when benefits are clear, the decision to take a drug involves weighing the benefits against the potential harms, costs, and alternatives. This story included some key basics around those points, but would have been bolstered by an independent expert’s viewpoint on the veracity of the study findings.
Tardive dyskinesia is a serious movement disorder that emerges as a consequence of long-term treatment with certain drugs used to treat schizophrenia and gastrointestinal conditions. It affects about 20% of people taking antipsychotic drugs. Presently, doctors try to prevent the condition from arising by using newer lower-risk drugs. If symptoms begin, patients and doctors must consider stopping the causative drug. In people with schizophrenia, stopping or switching medications can mean symptoms of the primary disease may re-emerge.
An independent source would have helped the story go beyond what the drugmaker’s executives have said, and helped people affected by this condition understand both the promise and potential pitfalls of a new drug. Is the evidence for the drug as solid as the drug company is saying it is?
Although there’s no cost estimate, the story informs readers that the newly approved drug doesn’t have a market price yet, but it should be available next month.
The article says that “40 percent of patients given a high dose of Ingrezza saw their movement symptoms decrease by at least half after six weeks,” whereas 19 percent of patients on placebo saw the same improvement. We applaud the reporter for relaying this information with the placebo measurement, but would have liked to seen a bit more detail on what a decrease in movements looks like. Did researchers count the number of movements or somehow measure the size or severity of movements?
On the question of whether the patients would have to take the drug forever, the reporter notes that “a small percentage” of patients who stopped the drug after year did not see their dyskinesia symptoms return. Encouraging news, but not a definitive answer on long-term symptoms.
The article lists the possible side effects of the drug, which is good. But that list left out a critical one that the FDA news release mentions: “serious side effects including sleepiness and heart rhythm problems (QT prolongation).” QT prolongation is a significant side effect in some patients with heart conditions or who are taking others drugs that also prolong the QT interval.
The reporter describes what the involuntary movements of tardive dyskinesia look like: “including rapid eye blinking, grimacing, lip-smacking and rapid movements of the trunk, arms and legs.” But it is not at all clear what was measured in the drug trial. Any movement? Just the biggest ones? Over a 5-minute observation period or for hours a day? What were the limitations to the study? These kinds of details help readers ascertain the veracity of the evidence.
The article does not engage in disease mongering. If anything, it downplays the fact that tardive dyskinesia is usually irreversible, a serious and permanent side effect that results from taking certain medications.
The only source cited in the article is the drug maker’s chief executive. Without talking to an independent expert who can provide insight, how are readers to know if this is truly an important new drug for an unmet medical need or an excited company head about to make money on the shares he owns?
The article makes clear that one alternative to the new drug is stopping the medication that caused the tardive dyskinesia, which comes with its own consequences. The reader also learns that a second drug company is expected to received FDA approval for its tardive dyskinesia drug later this year.
The article states that the new drug should become available next month.
This is the first FDA-approved drug for treatment of tardive dyskinesia, which the article’s headline makes clear.
The article does not seem based on this company news release.