The FDA and the Diet Pill Dilemma

Recently I've written about the FDA's needing to balance safety and innovation. A new opportunity is on the horizon that will put the Agency to the ultimate test. For the first time in over a decade, the FDA is considering the approval of a new diet pill... and more than one company has a promising product for the FDA to review. With the epidemic of obesity being one of our nation's biggest health concerns, it seems only logical that a weight loss pill that demonstrates some clear benefits should be given the utmost consideration. But history (Fen-Phen) and the potential for severe negative side effects has made the decision less than automatic. Determining the best approach requires a careful analysis of the level of risk that is acceptable when dealing with a crisis like obesity.

The drug combination fenfluramine/phentermine (commonly called Fen-Phen) was an anti-obesity treatment. Fenfluramine was created in the 70s and proved to only temporarily reduce weight. But when the drug was combined with phentermine in the 90s, its popularity soared and it was hailed as a miracle weight loss drug. That was, until 1996 when the New England Journal of Medicine published a paper reporting 24 cases of heart-related problems linked to Fen-Phen. Ultimately, the product was recalled in 1997 (one-third of the people taking it experienced heart valve damage), but the damage incurred before the recall was costly... approaching upwards of $13 billion dollars, to say nothing about the lives that were impacted negatively.

Unfortunately, the FDA did not fully do its homework on Fen-Phen. In 1994, the Agency became aware that fenfluramine was potentially linked to pulmonary hypertension, but refused to incorporate this into labeling (even though European agencies had already done so). This mistake has resonated throughout the years, and since then, the FDA has been reluctant to approve diet pills.

But almost 15 years later, the Agency has seemingly changed its stance. Today, obesity stands as one of our nation's most pressing challenges. Over two-thirds of the country is considered to be overweight or obese. And this is more than just a mere image problem. With obesity comes the rising cost of healthcare. The extra weight has been linked to chronic diseases such as Type 2 Diabetes and hypertension, and the cost of treating complications has been astronomical. The crisis has placed a disproportionately heavy burden (pun intended) on our nation's healthcare system.

In come Vivus and Arena Pharmaceuticals with their respective weight loss drugs Qnexa and Lorqess. In the last few months, both drugs have seen resounding approval by FDA panels. While these panels' votes don't necessarily mean that the drugs will be approved by the FDA, they have to be considered influential in the final decision. And this could be promising in the fight against obesity.

Arena's Lorqess showed an average weight loss of over three percent over a year, and over one-third of patients losing at least five percent of their weight. Qnexa demonstrated an even greater impact. Average weight loss was 11 percent, with 83 percent losing five percent of their weight or more. Both drugs demonstrated weight loss success that meets FDA standards for "significant" weight loss.

But it's not enough that these drugs may help treat the epidemic. They must prove to be safe as well. Research on Lorqess and Qnexa includes data that indicate some potential safety hazards. Lorqess may be linked to an increasing risk of high blood pressure in diabetics, or possibly damaged heart valves (much like Fen-Phen), and even a small chance of tumors (in rats). Research on Qnexa showed a potential rise in heart rate and heart palpitations, as well as the possibility of birth defects (such as cleft palates).

The FDA - although faced with the pressure of fostering innovation in the fight against obesity - can't afford to take these potential adverse events lightly. And to date, there is no sign the Agency intends to do so. Both manufacturers were tasked with additional studies and providing information to rule out these side effects, or to at least demonstrate they were not prevalent (prior to a final decision). In fact, the FDA will likely delay the final decision a few additional months to give Arena and Vivus ample time to properly collect data. Additionally, it appears as if post approval cardiovascular studies will be required (should either or both drugs be approved) to ensure that history doesn't repeat itself.

Obesity is clearly a huge problem for Americans. If there really is a pill out there that can assist in the weight loss process (in addition to changing lifestyle habits), the FDA has a duty to make every effort to get it to market. But it should not sacrifice safety to do so. The FDA must consider whether the benefits outweigh the risks... and even then, the Agency must still provide the entire story. Information needs to be effectively communicated to the public in the form of properly worded labels - and if brought to market, ensure appropriate post-market surveillance. And it seems that this is exactly what the FDA is on track to do.

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