Thank you for the opportunity to speak today. I am Dr. Nicholas Jury, I have a PhD in Neuroscience, was a post-doctoral fellow at NIH, and am now 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. Those are the perspectives I bring with me today. We do not accept funding from pharmaceutical companies and therefore I have no conflicts of interest.
The Center strongly supports research to advance the understanding of, and solutions to, cardiovascular disease. We also support the search for safe and effective alternatives to statins.
We were glad to see that Alirocumab lowered LDL cholesterol compared to placebo, but this effect is more likely to be significant for the men in the studies, not the women.
In addition to the lack of efficacy in women, there were no useful data for people of color. Approximately 95% of the patients were Caucasian. Subgroup analyses were not conducted to determine if this drug would be safe and effective in other racial and ethnic populations, and yet minorities have even higher rates of heart disease than Whites.
And of course, the fact that the drug lowered LDL does not prove it improves health outcomes for any group, as you all know.
In summary, based on the data provided:
- The data do not support approving this drug for women
- The lack of subgroup analysis makes it inappropriate to approve this drug for people of color.
- Although the drug lowered LDL cholesterol in white men, there is no conclusive evidence that it lowers their risk of heart disease.
In conclusion, we are asking you to reject approval of this drug for women and people of color until and unless subgroup analyses indicate the benefits outweigh the risks for those populations.
It is long past time that companies that want the FDA to approve their drugs for all adults do a better job of proving they are safe and effective for all adults.