Miracle weight-loss drugs? Not so fast.
When the weight-loss drug Fen-phen etched itself into the American consciousness in the late ‘90s, the early results looked promising – at last, just taking a pill could cause pounds to drop off quickly; but the magic ended when researchers found that the pills caused severe heart valve damage that required surgery to repair.
Since then, the U.S. Food and Drug Administration has taken other weight loss drugs off the market, removed for causing scary side effects, including possible death. The most recent prescription drug to go was Meridia in 2010.
Any new drug faces a mountain of skepticism and justifiably so, according to one of the Cleveland Clinic’s best known cardiologists – Dr. Steve Nissen.
"The problem we face with obesity drugs is they have a pretty horrible track record. You know, this track record has made the FDA cautious, it's made the public cautious and it's made the requirement that we really think our way through this and do careful clinical trials, it's made it much more important to do that," Nissen said.
Nissen is well known for his work raising alarms about other drugs such as the diabetes drug Avandia. So, when the FDA approved a new weight-loss drug called Qsymia late last year under the condition that a long-term trial be conducted after its release to consumers, the makers figured who better to oversee that trial than someone with a watchdog reputation like Dr. Nissen.
Nissen agreed and will begin enrolling patients in a long-term trial for Qsymia early next year.
"We've had drugs approved and come to widespread use that ultimately proved to be harmful and we've also had drugs come to widespread use that turned out not be effective because they were approved based upon the wrong studies. Now, what I've argued is for more rigor and I don't think it's ever a mistake to do that," he said.
Qsymia is recommended by its makers for patients who are obese or overweight and suffer at least one serious medical condition, such as Type 2 diabetes or high blood pressure. In the early trials, those taking Qsymia showed a slight uptick in heart rates. Regulators expressed concern about the possibility of heart attacks and strokes.
Dr. Nissen says there’s a need for medications that will assist in fighting obesity. But some others with watchdog reputations disagree. Dr. Sidney Wolfe, a founder of the consumer group Public Citizen, says that doing a long-term trial to address heart attack and stroke concerns after the drug goes to market is not fair to the American public.
"This was a reckless decision and it doesn't go along with what we think public health is about, which is harm reduction, precautionary principal," Wolfe said.
Wolfe has added Qsymia and the other newly available weight-loss drug called, Belviq to his consumer database worstpills.org. He shares concerns that Qsymia will cause heart attacks and other severe side effects. But he's also concerned about Belviq, saying that early trials revealed heart valve damage in some patients taking the drug.
Wolfe wrote a column published in British Medical Journal in August noting that the FDA's counterpart in Europe - the European Medicines Agency - rejected both drugs.
The agency had said that the amount of weight loss caused by Belviq and Qsymia - both 10 percent or below - just wasn't worth the risks that the drugs posed, says Wolfe.
The Cleveland Clinic’s Dr. Nissen says he believes Qsymia is safe for the market and added that there will be appropriate precautions during his trial, including the use of an independent review board that can recommend stopping the study at any time.
Qsymia's parent company Vivus did not respond to requests for an interview. Last week, financial analysts reported that Qsymia's parent company was laying off 20 employees because of lackluster sales.
Arena Pharmaceuticals, the maker of Belviq, did agree to talk. Chief Executive Jack Lief said he felt very comfortable from pre-market trials that the drug is safe for patients.
"Belviq is not a stimulant and there's no heart rate issues, there are no blood pressure increases or anything like that. And then we tested our drug really extensively, the drug went into human testing beginning in 2004 over 9,000 patients were involved in that testing. In the phase three studies alone, some of the patients have been on for two years. So, the drug has been really well evaluated during the clinical process," Lief said.
Arena did get some welcomed news in late October. An industry analyst commented favorably on new forecasts for Belviq from the company’s executives.
"Expectations for sales,” he wrote, “have finally come down to reality."