In December of 2007, my primary care physician measured my weight at 293 pounds, and implored me to lose weight because he had no more medications that could help me with diabetes, high blood pressure, and high cholesterol. I told him I was entering a clinical trial of a new weight loss drug called lorcaserin. He was skeptical.
Lorcaserin eventually showed that it could help people lose weight – in my case a life-altering 55 pounds. But now the drug, which was approved in 2012 under the Belviq brand, has been removed from the market because of a signal that it may increase the risk of cancer. I chronicled my trial results in a series of articles and videos for 乌鸦传媒 during 2008 and 2009.
The latest twist in the long history of lorcaserin which struggled to prove to the FDA that it did work to reduce weight is distressing in a number of ways.
I have been an unabashed advocate of the drug because it took me from a heart-attack-in-the-making to someone who can climb stairs without puffing. I told anyone who would listen how much the drug helped me, and how I experienced no adverse events, no vivid dreams, no night sweats, no thoughts of suicidal or homicidal ideation.
So it was a shock to read that the drug was being removed from the market.
The FDA approved lorcaserin in 2012, but the agency required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems. In that trial, it was found that 7.7% of patients on lorcaserin were diagnosed with cancer compared with 7.1% of patients taking placebo. The study was conducted among 12,000 patients over 5 years. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.
My last dose of lorcaserin was in January 2009, and, so far, thankfully, I have not been diagnosed with any cancers. Interestingly, I was prescribed lorcaserin after it was approved because my weight had edged upwards in the period from 2009 to 2012. But I never filled the prescription because it was not covered by insurance and was financially toxic for me. I was a bit miffed that Eisai, the company that took over for Arena in marketing Belviq, did not have an extension trial. I would have liked to have taken the drug for an extended period of time – but considering recent events, one should be careful for what one wishes.
At any rate, I have managed to keep my weight under control without the drug, and have since been able to reduce my weight back to the level of 2009 when I stopped taking lorcaserin, about 228 pounds.
So now I wonder if I am out of the woods for cancer due to lorcaserin. Although there was a greater risk of cancer in the new study, the absolute increased risk was 0.6 percentage points greater than people who did not take lorcaserin. But there was no heart-attack benefit with lorcaserin either, so the risk-benefit ratio appears to have tilted toward overall harm.
Nevertheless, for me, I will always think of lorcaserin as something that benefited me greatly, and that for me it worked very well. I recall that in April 2008, when I saw my primary care physician after about 3 months on the clinical trial, he looked at my chart in shock and said: "How did you lose 27 pounds in 3 months ?" I was then at 266 pounds on his scale.
I told him, "Well, I'm in this clinical trial, but I could be on placebo."
He waved off those comments. "You are not on placebo," he asserted.
He was right.
But lorcaserin wasn't a complete miracle for me. I was probably 100 pounds overweight when I started on the clinical trial. And I am still more than 30 pounds heavier than I should be. There is still work to be done – but it is going to be done by diet and, ugh, exercise.
Considering everything that has occurred over the past 12-plus years, I am still happy that I was in the clinical trial and was one of the program's biggest winners by being one of the biggest losers.
Ed Susman is a veteran medical journalist who has written frequently for 乌鸦传媒 and other publications.