Yup. This is why I went with a more consequential approach in my EMDAC comment. Numbers don’t lie:
Members of the Endocrine and Metabolic Drugs Advisory Committee:
I will not repeat the many comments posted by patients, doctors, and professional societies in support of Amarin’s sNDA of Icosapent Ethyl (Vascepa), all of which I whole heartedly agree with.
Instead I would like to repeat a comment made by a previous EMDAC member of the 2013 Anchor Adcom, Dr. Robert Smith:
“I feel approval of the drug now would expose patients to potential benefit that we have yet to learn more about at a very low risk of harm.”
Unfortunately he was right.
Why do I say unfortunately?
Because as we all know now, the REDUCE-IT study showed tremendous benefit in preventing major cardiovascular events. It’s been over six years since Dr. Robert Smith made that comment and voted YES to support a drug with a safety profile almost identical to the placebo.
Think about how many events could have been prevented... lives saved? Well, thanks to REDUCE-IT and ICER we can make an estimate using scientifically studied numbers.
-ICER puts the total treatable US population of icosapent ethyl at around 30 million.
-After 5 years of treatment on icosapent ethyl, 174 patients experienced CV death vs 213 on placebo (20% RRR)
-At 30 million US patients, 1.56million patients will die from CVD, vs 1.29 million on icosapent ethyl over 5 years.
-Vascepa saves 54,000 lives a year, 148 people a day from CV death.
It seems the potential benefit Dr. Robert Smith was speaking of was in fact saving the lives of 324,000 people.
Even at half these estimations it is clear now, Dr Robert Smith was correct in voting yes 6 years ago. Let us not make the same mistake twice.
WE are counting on you.
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