Weighing obesity drugs: Panel ponders what’s next
With two new prescription weight-loss drugs approved for the U.S. market and a third under consideration, an industry-sponsored panel of experts has adopted a welter of recommendations on how the new crop of medications should be used, how their risks and benefits should be assessed by physicians and regulators, and what patients should expect of them.
On the last of those questions--what patients should expect of the new drugs--the expert panel urged the Food and Drug Administration to “help patients manage their expectations regarding obesity drug use.” The panel noted that for those taking any of the drugs newly approved or still under consideration, weight reduction would likely plateau at 5% to 10% of body weight loss. Patients should understand that “such weight loss is not likely to produce dramatic results in physical appearance” but could result in”significant improvements in health,” the panel declared.
The report released Tuesday, titled “Obesity Drug Outcome Measures,” reflects the consensus of a “dialogue group” convened by public health experts at George Washington University in Washington. The group and its consensus report were funded with grants from five pharmaceutical companies (among them the makers of the newly approved Qsymia and Belviq and the candidate drug Contrave) and the Obesity Action Coalition. The group’s aim was to consider the regulatory and public health challenges of pharmacological interventions for obesity.
The consensus group’s 19 signers included three employees of pharmaceutical companies, with the remainder coming from universities, clinical centers and groups active in public health promotion and research. Seven senior officials from the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health were listed as nonvoting “observers.”
Among the group’s recommendations: that the FDA and makers of obesity drugs quickly develop a registry of children and adolescents who use the medications so that those with long-term exposure to the drugs can be identified and tracked.
The group also recommended that in approving future drugs, the FDA might depart from existing practice and approve certain medications for restricted use by sub-populations of obese patients. The FDA has been cautious in approving medications that in broad use might lead to a rash of birth defects or heart problems. Such a conditional FDA approval would recognize that for some patients the medications may be too dangerous for the broadest use, but could benefit a subset of dangerously obese patients.
In discussing future candidate-medications for weight loss, the panel also recommended that the FDA take into consideration measures of benefit that it has not recognized in assessing the current crop of candidates.
Qsymia, Belviq and Contrave all have been required to bring about weight loss of at least 5% of subjects’ body weight in 35% of clinical trial subjects, and to perform statistically better in inducing weight loss than placebo drugs. The panel report issued Tuesday urged the FDA in future deliberations to consider the effect of future drug candidates on patients’ quality of life, including mobility, joint pain and sleep apnea.
