Deaths attributable to the SPA rescission –
I’ve been honing my version of the Vascepa saga, and added remarks about death caused by the SPA rescission. I post it below, and welcome corrections and comments.
BTW, the Shawshank reference is very appropriate. I love that movie. Seemingly endless nightmares do end, and Amarin’s will.
My father suffered for years and eventually died from a series of strokes, and both my grandfathers died of CVD, so, as I wait my turn, I have strong feelings about CVD. (I already take Vascepa and B complex off-label based on advice from this board (thanks for that BTW), but my wife’s doctor won’t prescribe off-label.)
Life and Death Consequences of the Anchor SPA Recission
A crucial question I haven’t heard the FDA ask is 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, 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 lower dose), and a typical major cardiac event rate of 5% in 5 years (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 assumptions, rescinding the SPA can be expected to cause in the ballpark of an additional 100,000 major strokes and heart attacks over a five year period, including 20,000 deaths [footnote: due to biological and marketing delays, each day of delay causes 10 expected deaths about 3 or 4 years later.]. Given the conservative assumptions, it could easily be several times that. With foreign markets often following US approvals, and the disincentive to future innovation, it’s not crazy to wonder if this one incident could cause a million deaths globally over the next 20 years, with millions more disabled.
But, it’s enough to consider the 20,000 preventable American deaths that seem quite certain within a few years (about three times more than 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, ten will slip beneath the waves daily for five years. As of mid-2015, over 6,000 have already been doomed since the delay began in December 2013.
Although we don’t know exactly who they are, these are thousands and 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. We must help them get back on track. I believe they chose careers in medicine and public service to help people, not to cause death.
No one says not to test, but with so many lives at stake while we wait years for the results, doctors need access to the best available option based on current information, and they need unhindered access to that information.
