Midwest Chick's Place

The folks at the Brownstone Institute take a look at a study by Jeanne Lenzer and Shannon Brownlee regarding FDA approval of drugs. The results are telling.

73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

And worse:

But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”

“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.

More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively. 

This is reflected in the new CDCs panel’s approval of an RSV shot for babies as well.

Two of the panel expressed concerns.

“In one of the trials, immunized babies admitted to the hospital for RSV-related illness stayed longer than non-immunized babies with the same condition. Levi said this raises concerns that the immunization may have worsened their illness — a phenomenon called immunization-enhanced disease, which has complicated previous attempts to develop an RSV vaccine for infants,” it continued.

…

A researcher from the FDA acknowledged Levi’s point, saying “numerical numbers go in the wrong direction,” but the percentage differences were very small, between 0.2% and 0.3%, she said.

Co-chair Martin Kulldorff, Ph.D., said it would be critically important to monitor adverse events going forward.

So they are going to wait until the shot is widely disseminated and used rather than catching problems on the front end. And they are going to, most likely, rely on VAERS for reporting, which has been shown to be woefully inadequate.

And doctors don’t know any better either.

Of 1148 physicians contacted, 692 physicians (60%) responded: mean age, 46 years (SD, 10); women, 45%; specialists, 79%. Nonrespondents were similar: mean age, 49 years; women, 43%, and specialists, 80%. Respondents showed limited knowledge of FDA approval: 73% (95% CI, 69%-76%) incorrectly believed FDA approval meant comparable effectiveness to other approved drugs; 70% (95% CI, 66%-73%) incorrectly believed approval required both a statistically significant and clinically important effect. 

Which is something we pretty much knew. This process has been running on incorrect assumptions: it’s assumed that the FDA won’t approve something unless it meets the four basic criteria: “presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival” and that’s not happening.