Dangerous Crosscurrents for Obesity Medicines
Dangerous crosscurrents remain in the regulatory environment for obesity medicines, even though progress has been considerable over the last five years. You need look no further than headlines of the last week.
In just one news cycle Orexigen — the originators of Contrave — made both good and bad news for themselves when they disclosed interim results from an ongoing cardiovascular outcomes study. At first glance, investors cheered the findings which showed a 41% reduction of major adverse cardiovascular events — heart attacks, strokes, and deaths. Their stock price jumped by 47%.
But then came a backlash from FDA, and a 16% drop in the Orexigen stock price. John Jenkins, Director of FDA’s Office of New Drugs, characterized these interim results as “highly unreliable,” “misleading,” and “likely false.” In expressing his concern about the release of these preliminary data, he said:
The paradigm has always been that the interim analysis data must be kept very confidential so that it doesn’t become available for business purposes within the company.
In plain English, this means FDA is totally ticked. Given that regulatory decisions always require FDA to make a judgement call, a company that ticks off the agency can wind up paying a heavy price. Trust is essential and extremely fragile. If Orexigen is indeed “crying all the way to the bank” (as Forbes suggested in one story about the situation) they might not fully understand how much grief they could eventually suffer because of a loss of trust with FDA.
A less risky way to release new clinical results came from Novo Nordisk in the same week. At the annual meeting of the Endocrine Society, Patrick O’Neil — a respected, independent obesity scientist from the Medical University of South Carolina — presented 56-week results from a study of liraglutide (Saxenda) that will continue for a total of three years in people with obesity. Active treatment more than doubled the odds of people achieving a 5% weight loss compared to people treated with placebo, diet, and exercise. Plasma glucose, waist circumference, blood pressure, and quality of life were all improved as well. The investigators stuck with the facts of this planned analysis without making inferences about longer-term outcomes.
It hasn’t been long since FDA was turning up its nose at every new obesity drug that came up for approval. We’re in a better place now, with more balanced consideration of medical needs and risks. But dangerous crosscurrents remain.
Sloppy mistakes by industry can be costly to people with obesity and professionals who care for them.
Click here and here to read more about the misadventures of Orexigen. Click here to read more about the liraglutide study and here to access the study abstract.
Medicine Bottles, photograph © Leo Reynolds / flickr
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