Amended estimate of deaths caused by SPA rescission -
The FDA didn’t ask how many lives are likely to be saved or lost by delaying access to Vascepa. We can make a quick but reasonable ballpark estimate.
Using round numbers on the low side of what’s likely, let’s assume a 5 year delay, ten million at-risk US patients after post-approval ramp-up (a small fraction of the Anchor population), modest 20% CVD risk reduction (less than JELIS attained with a smaller dose), and a typical major cardiac event rate of 5% annually (assuming 20% of events are fatal, which is low). As an exceptionally safe drug from a safe class of drugs, Vascepa has a negligible death rate.
With these conservative assumptions, rescinding the SPA can be expected to cause in the ballpark of an additional 500,000 major strokes and heart attacks over a five year period, including 100,000 deaths [footnote: Due to biological and marketing delays, each day of delay causes about 50 expected deaths about 3 to 5 years later.]. It could easily be several times that. With foreign markets often following US approvals, and the disincentive to future inovation, it’s not crazy to wonder if the deaths stemming from this one incident could be millions globally over the next 20 years, with several times as many disabled.
But, it’s enough to consider the 100,000 preventable American deaths that seem quite certain within a few years (about twice as many as US combat deaths in the Viet Nam War, about a third as many as in World War II, and more than 10 times the Iraqi and Afghan wars combined from 2001 to 2015). After REDUCE-IT, we’ll know better how many, but it will be too late to do much about it. It’s like a lifeguard forbidding good ropes to be thrown to drowning people until extra tests are completed, while the drowning people struggle with dangerous, useless, rotten ropes. Under our conservative assumptions, fifty will slip beneath the waves daily for five years. As of mid-2015, over 30,000 have already been doomed since the delay began in December 2013.
Although we don’t know exactly who they are, these are tens of thousands of real people with loved ones and hopes and dreams for a future they will never see because some people at the FDA have lost their way. I believe they chose careers in medicine to help people, not to cause death, and they need help to get back on track.
While Anchor was under review, niacin was found ineffective and dangerous after many years of wide use, and I’m sure the FDA was outraged and frustrated when they couldn’t withdraw approval. [The difficulty FDA has un-approving drugs is well-known.] It’s natural to over-correct, and they veered from one extreme to the other, perhaps taking their frustration out on Vascepa instead of niacin, because they could. Now, with more information available, it’s time to calmly rethink the situation and steer back toward the reasonable middle of the road.
No one says not to test, but with so many lives at stake while we wait years for the results, doctors need unhindered access to the best available option based on current information.
AI
