There’s a Reason Behind FDA “Red Tape”

And even then it’s not good enough

The pop-up experts on Twitter seem to believe that you can just poop a ventilator or a new vaccine if only the “red tape” was eliminated. There is actually some value to all that red tape in keeping us safe.

Back in 1999, Merck came out with a remarkable drug for managing pain for arthritis called Vioxx. It was considered much safer than steroid alternatives. In 2004, it was pulled off the market when it became clear that it roughly doubled patients’ risk of heart attack and stroke and lead to an estimated 60,000 deaths. In 2007, Merck  Merck agreed to pay $4.85 billion to settle 27,000 lawsuits.

What went wrong? Here’s the thing — nothing. Of course, there are lots of people who speculate that Merck knew or should have known.

FDA originally approved Vioxx in May 1999.  The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke.

A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000.  The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx.

Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial.  In the APPROVe trial, Vioxx was compared to placebo (sugar-pill).  The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps.  This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

To wrap this up, there is criticism that Merck should have been more conscious of the heart attacks in the VIGOR study and pulled Vioxx at that point. There were also three heart attacks that were not reported in the original VIGOR data which some said believe Merck hid from the medical community.

About 20 million people took Vioxx including my father-in-law. The mortality rate was 60,000/20,000,000 = 0.30%.

Vioxx was considered a debacle and a stain on the FDA testing procedures.

In Italy, the mortality rate of coronavirus is 7.8%.

The question before is what mortality rate for a new drug would you find acceptable? If we had a vaccine that we gave to 5,000 people and 3% died from the vaccine — ten times Vioxx — or 1,500 would that be OK? Perhaps if 1,500 survived who would have otherwise died. Of course, for this to work, you’d have to give the pill to all 5,000 people regardless of how serious their symptoms and their age. If you just gave the pill to the elderly who were likely to die anyone, then the mortality rate would be astronomical. Would you be OK with indemnifying companies that produce this drug from lawsuits?

This morning Scott Adams tweeted:

Ventilators require sticking a tube into someone’s windpipe. There are good reasons why this is a minimum of two years of training. So, no Scott, we have what we have. Throwing out the red tape entirely is going to get a lot of people killed with good intentions.

Mark Rosneck

Written by Mark Rosneck

Site owner and bilagáana


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