Yet another miracle drug

Something remarkable happened in the USA last week: An advisory panel recommended the weight-loss drug Qnexa for approval by the influential U.S. Food and Drug Administration (FDA).

What makes this remarkable is that the FDA is notoriously strict on such products. In fact, the last time it approved a weight-loss drug for use in the USA was 13 years ago. In this time it has also forced countless products to be withdrawn from the market because of concerns over heart risks and other side effects. (The FDA usually follows panel recommendations, but may decide not to do so. It will make a final decision by April 17.)

The recommendation is indicative of the level of desperation in a country where obesity has escalated out of control. Qnexa’s possible side effects are serious and well-documented and it was rejected by the same agency in 2010 after a 10 to 6 vote against its approval, which included about half of the same members as this time round.

But last week, the panel agreed that the health risks of obesity and the benefits of losing weight outweighed the risks posed by the drug. That is chilling, given that these possible health risks include heart problems, birth defects in babies of mothers who takes the drug while pregnant and mental effects such as lack of concentration.

Since the 2010 decision, Qnexa’s manufacturer, Vivus Inc., has undertaken to try to minimize those risks through measures like clear labelling and an additional trial to investigate cardiovascular side effects. And, they point out, the risks of untreated obesity is even higher.

Part of the dilemma is that possible negative effects will not stop Qnexa from being an immediate and spectacular success – and making Vivus very, very rich.

“This is far from a great drug,” dr. David Katz, director of the Yale Prevention Research Center, told Associated Press. “The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that: desperation.”

Qnexa is a cocktail drug that combines the effects of the appetite suppressant phentermine and the anti-seizure drug topiramate. Vivus Inc. claims its product helped patients lose at least 10% of their weight after a year of treatment. Yet phentermine was also found in Fen-Phen, a notorious combination of drugs once popular in the 1980s. Prescribing the Fen-Phen combination was later prohibited because of damaging users’ heart valves and causing spikes in heart rate and blood pressure and resulting in heart palpitations.

For South Africans, Qnexa poses another important question: If a product this controversial battles to win approval in a tightly regulated market, yet promises only 10% weight loss after a year of use, what does that say about the dozens and dozens of “miracle” pills and potions available freely and without prescription on local shelves?