The FDA has dubious standards

FDA has been playing this game for a while. Understanding how the game is played puts the COVID vaccines situation in context.

The FDA approves drugs, but its standards have been slipping for some time. This 2013 Harvard blog highlights that one in every five approved drugs “ends up causing serious harm.” Also noteworthy, 90% of all new drugs have “little” benefit over existing drugs and there are 53,000 excess hospitalizations and 2400 excess deaths every week.

A more recent study in 2017 showed that “nearly a third of FDA-approved drugs had problems… As the study notes, the majority of these drugs were trialed in 1,000 or fewer patients to get FDA approval”.

This 2022 NPR article shows that badly this process is accelerating. Now, new drugs “need to do an additional study after the drug is on the market to prove the drug really works.” As the article notes, many companies have “fallen behind” in completing their “confirmatory” studies to show that their drugs really work.

As NPR states, this has been ongoing for 30 years, with 42% of drugs not having started their trial for a year or more:

And maybe you can spot the trend this has been heading in:

And safety? Well, it seems it has been an issue.

From 2013: “Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits… Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate.”

Each year, “more than 2 million Americans suffer serious adverse reactions from FDA-approved drugs… these side effects lead to about 100,000 deaths.”

Pharma companies are no stranger to fines.

Even worse, the rate of fines has been increasing in past years. Pharma companies have figured out that they can get by the fines by increasing drug prices. In other words, the fines are not incentivizing the companies to stop illegal activity:

Who funds the regulators? Well, actually it’s mostly the companies now in several of the largest economies. This BMJ investigation reveals the US has increased its fees from the pharma industry “30 fold”, 65% of the FDA budget, and the EMA receives 89% of its budget covered by the pharma industry:

And here’s Taking Action to Clean Up the Medical Misinformation Mess by Dr Aseem Malhotra:

So that’s a decent overview of the scale of the problem.

And the FDA isn’t the only problem.