Sunday, October 24, 2021

FDA’s definition of a miraculous success rate in heart disease treatment has a flaw

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For the people with heart conditions who take COVID-19, a trial that proved the drug significantly improved their heart function, the welcome news was a double helping of good news. The Food and Drug Administration put forth two draft guidelines for approving the drug to treat heart failure – it will soon be in use in 41 countries. Scientists at the World Health Organization went a step further and pronounced COVID-19 an unlikely death sentence for heart failure patients. For the people who take COVID-19 – even the full treatment schedule – their chances of dying from heart failure decreased as much as 32 percent.

But for the people who take COVID-19 – the full treatment schedule – their chances of dying from heart failure decreased as much as 32 percent.

The FDA, though, is not so sure. The heart values overrode by COVID-19 have no obvious association with what happens to the heart after COVID-19 is taken. If most people’s chances of dying from heart failure were reduced by 33 percent or less, that’s an undeniable positive, perhaps even earth-shattering change. But it’s not an overwhelming positive, perhaps even less overwhelming than it sounds. The FDA is putting its blessing on COVID-19, but this time around, the FDA seems only slightly more than mildly enthusiastic about the drug. At the very least, COVID-19 has clear hurdles to achieve that seemingly remarkable benefits.

The FDA’s guide puts COVID-19’s efficacy in perspective. The most the FDA expects a miracle to deliver is a six-month reduction in heart failure deaths. The other guidelines put COVID-19 in a category of its own. More or less taking COVID-19, the guides say, has no clear health benefit but does have “potential short-term cardiovascular side effects.” If the drug works in this way, COVID-19 is no longer the miracle that the World Health Organization and the FDA have enthused over.

Perhaps they’ve learned something in recent years from the EpiPen debacle, or some other drugmaker’s mounting piles of press about the risks and side effects of their medications. Maybe the CDC, which is advising those taking COVID-19 to exercise in front of their doctor if it’s causing an irregular heartbeat, and reporting that number of episodes of arrhythmia, is now better able to speak to the prescription. It’s a common surprise to people who’ve been prescribed a new drug that they actually developed a small risk of developing a serious problem within weeks or months.

There’s no indication that the FDA has learned much from this history, either. In a two-page document addressing the FDA’s draft guidelines, the American Heart Association called out the FDA for explicitly not recommending that the COVID-19 population be lowered to a different dose of the drug. The Heart Association had already determined there was no safe lower dose for the COVID-19 population, so the FDA did not need to recommend that a different dose be used, the heart association said in its statement, calling the FDA’s draft guidelines “standard public health practices.” The Heart Association said the FDA should have endorsed the Heart Safety Technology Advisory Committee’s advice, which said “yield-reduction therapy” of COVID-19 patients should be evaluated “regardless of dosage” and that using COVID-19’s data to suggest the drug should be lower than the recommended dosage of 10 milligrams a day should be avoided.

Ultimately, COVID-19 was approved for use in this population last December. It’s unclear what will be known and what will be known as COVID-20, the FDA’s guideline on the final approval of COVID-19. Because there isn’t one, it’s up to health officials to think this through. There is a way to be confident this drug will save more lives than it will kill, but it may just be that the way it’s being used, COVID-19 isn’t smart enough to do it.

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