My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug companies, and therefore I have no conflicts of interest.
We all know that obesity comes with many health risks, and millions of Americans would benefit from safe and effective treatment options. After a careful review of the data, I am sure that many of you share our skepticism about whether Liraglutide meets the standards of safety and efficacy that patients and consumers deserve.
1) Like most weight loss strategies, this drug helps patients lose weight during the first year. But obesity is usually a chronic condition and any potential treatment should be studied for much longer than 1 year. We need more than 2-year data to know if the drug is effective and safe.
The data from the largest trial (trial 1839) show that patients in the Liraglutide group were almost 3 times as likely to experience an adverse event compared to the placebo group, some of them serious. When the weight management data were pooled, patients on Liraglutide were more likely to experience gallbladder disorders and pancreatic conditions. Victoza when used for diabetes, has been found to cause pancreatitis in post-market studies. Now that we know these risks, we need to be very concerned about them with Liraglutide as well, since it has the same active ingredient. At the very least, longer term studies are needed BEFORE Liraglutide is approved and BEFORE patients are buying it.
2) We question whether this drug will work effectively and safely in people of color. Pooled data from the 4 phase 3 trials showed that Black patients made up only 11% of the trial samples and Hispanic patients made up only 10%. The sponsor states that the U.S. trial population reflects the racial and ethnic distribution in the U.S. but it does NOT reflect the prevalence of obesity in these racial and ethnic groups.
Black adults, particularly Black women, are more likely to be overweight and obese than any other racial group in the U.S. They are also more likely to have sleep apnea and type 2 diabetes. Because the sponsor did not conduct any subgroup analyses, despite FDA guidance to do so, we don’t know about the safety or efficacy for Black men or women based on these data.
If the sponsor wants this drug approved for all adults, not just White adults, it needs to be analyzed separately for a reasonable number of Black and Hispanic adults.
We urge you to vote that the benefit-risk assessment is NOT favorable and does NOT support approval because of the lack of data on long-term efficacy and safety AND the lack of meaningful data on safety and efficacy for people of color.