Yeah this is the biggest load of hog wash I’ve ever read.
For the record. I spent several years working in biopharmaceutical manufacturing. For multiple different global giants in the industry.
From cell culture to protein purification making mono clonal antibodies to final fill processes and lyophilization in viral vaccine manufacturing.
As far as regulatory oversight goes pharma is second to only one other industry.
Can you guess which one? If not I will tell you. Its the nuclear industry.
Did you read the article? The title of your post is not accurate. And the articles do not substantiate that claim.
Undoubtedly the article highlights an important issue.
What does the article say.
The drug was approved even though two RCTs showed no patient benefit.
They were approved because they did a post hoc analysis that showed decreased beta amyloid plaque.
So the whole issue is the surrogate end points.
At the end of the day these companies are trying to make money. But they can only make money if they bring a drug to market. To do that they have to play by a strict set of rules outlined by the regulatory agencies. Like any rule set there is a risk for exploitation. Which is perhaps what we are seeing here.
But by far and large. Drug companies are mandated to produce safety data via various stages clinical trials. Which is rigorously evaluated by the regulatory agencies.
And for the record it doesn’t stop there.
Every batch of drug I was ever involved in has literal tons of hard copy paper work where each step of the process is performed by one individual and verified that it was done according to SOP by another person.
Even stuff as trivial as standardizing a ph meter is performed to stringent criteria observed and verified.
I have personally seen near 50 million dollars worth of product “dumped” down the drain because of a careless mistake, something like media for cell culture being held in a tank for 5 hours when the process has only been validated to hold it in a tank for 4 hours and 45 minutes. Even though the media was still very likely good our manufacturing standards are so high that we do not even consider taking the chance. Why because patient safety is number one.
Well. I’ve rambled on long enough.
Point is. Big pharma is safe. Is it perfect no. But its closer to it than any other industry and constantly moving closer.