The FDA Is Approving Drugs Without Evidence They Work
>Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with clear signs that they pose a risk of serious harm.
The article brings up some great points, some of which that I, an industry insider, weren’t even aware of, especially the historical context surrounding the AIDS epidemic. I’ll jump into the thread to critique an issue within the article.
One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.
If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.
Happy to answer questions about the industry if anyone has them.
technocrit