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.
When it comes to therapies that are likely toxic, e.g. chemo, that’s why the sponsor has to demonstrate through pre-clinical data that there is a high enough likelihood that the benefits will outweigh the harm that it is a legitimate therapy to trial on humans. Even then there should still be thorough, audited processes for obtaining fully informed consent before recruiting patients into these trials, including making certain they are aware the trial may cause more harm than standard of care.
It’s the burden of evidence required in pre-clinical data that makes me defend animal testing despite being vegan.
The consent process for clinical trials has a ton of guidance (ICH GCP), but the onus is on the clinical monitors and hospitals to make sure it’s done correctly. Many trials now generate supporting documentation in which hospital staff are required to describe the circumstances in which consent was acquired. If the documents are generated, then it’s auditable.
Things get a bit hairy when you look at trials in Alzheimer’s and other cognitive disorders, because the patient may not be coherent enough to withdraw from the trial. In those cases, a legal guardian is responsible for the decision.
Yes, though if the sponsor is doing it on the cheap then they might pick facilities and monitors who don’t care or don’t have the capacity to pick up on all the details, or scrutinise minutiae. The monitor can only QC what’s written down for example, and an investigator can be perfectly capable of having the bare minimum of a consent process and copy pasta as if it was done thoroughly.
I’m glad all my participants are of sound mind; the idea of navigating the world of incapacity and research gives me the heebie jeebies.
technocrit