T Nation

Most FDA-Approved Drugs Are Never Tested

Most drugs approved by FDA have never been tested to be either safe or effective. That comes as news not only to the public – but to most doctors.

Aaron Kesselheim, a professor at Harvard and one of the FDA advisers who resigned in protest over the approval of aducanumab—reported that only 41 of 687 (6%) US physicians correctly answered the following question:

For a drug to get FDA approval it has to have: a) a statistically significant result; b) a clinically important result; c) both results; d) neither of the results.

The correct answer is d.

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For this to be true, significant torque must be applied to the words approved and tested.

In my experience, individuals who make this sort of statement typically have an agenda beyond the words on the screen. Do you have an agenda of this sort? If I may ask, what is your top-line point?

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It was a post by Jeanne Lenzer a medical investigative journalist.

You can ask her directly.

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No agenda
… But I have a bridge and a bottle of snake oil i’d like to show you!

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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.

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Do you realize that due to climate change all the suckers over the years who bought the deeds to Arctic resort properties finally realized a good deal?

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I’ve pointed this out re the people who argue those taking covid vaccines are Lab rats

The only Lab rats were those in the initial trials (as some vaccines bypassed rodent models)

I can understand why some are skeptical as I think there’s a lot of misinformation going around. I can also understand why one might not want their young child to be given a vaccine wherein the possibility of a SAE may be higher relative to actually catching covid (in covid zero states).

For instance around 0.2-0.5% of children appear to be hospitalised after catching covid. However the death rate is veeeerrrrrry low for kids. You’re arguably more likely to contract myocarditis from Pfizer, or acquire TTS from AZ… Or even die from AZ then you are to die from covid as a healthy 10y/o kid

Still, I’d advocate for vaccination to reduce community transmission. Lessen burden on hospitals mediated by downstream transmission.

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Well thats a slightly more complex issue.

I have only every been involved in large scale manufacturing once a drug has already been brought to market.

Having said that. I am aware that part of the data set includes longitudinal data. Which there is obviously a lack of with the COVID vaccinations. Well at least initially. I am sure we have people 1 + year out from their first dose now. I understand the hesitancy. I appreciate the hesitancy. And I am conflicted on the issue. But like you I still think everyone should get vaccinated.

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Good to know after taking a break from that PWI never changes :joy:

People really have no idea how stringent the regs are for drug development. It’s absolutely unbelievable. I’ve been involved in the basic lab research aspect, and while you have a much better understanding of the manufacturing regs and QA than I could the pre-manufacturing oversight is just as strict.

Important debates concerning surrogate endpoints and allowing post-hoc analysis - and/or disregarding clear guidance from committee as in Biogen’s case - are completely and utterly different than saying “most drugs are never tested for safety and efficacy”.

Wow.

Also agree. I feel personally that the vast majority of hesitancy now is being pushed or influenced by anti-vax conspiracy bullshit. But like you I am conflicted, because I definitely appreciate that there are real issues and trade-offs to be made and that it can be a messy decision. My cousin has two boys that she has not vaccinated yet, so this conflict is close to home. She is hardly a conspiracy nut, but just trying her best and talking to doctors.

Its like the warm comfort of returning to your parents house after many years away to see that things are just the way they were when you left.

They really don’t. But that is ok.

My thought exactly. Wow.

My sister refuses to get vaccinated. She has a certain susceptibility for conspiratorial bullshit.

I remember vehement opposition to vaccinating a child for Hep B. “Why do they need to vaccinate my child for a sexually transmitted disease.”

Oh that was a fun one to try to unpack. It was crystal clear. From an epidemiological standpoint. How many people for first two maybe even three decades of their life have very limited interaction with health care systems. Get them while they are young.

300 million people living with chronic hep B in the world. That is nearly the population of the states. Imagine that. And 1/4 with chronic hep b die of either cirrhosis or hepatocellular carcinoma. So we are likely talking about billions of dollars spent managing sequelae of chronic hep B. Now obviously most those cases are in south east Asia. But that is only because the West vaccinates against it.

My dear sister also was hesitant to microwave food for a while because she believed it was bad for her health. I also tried explain that it is simply a light wave. Like a rainbow that just so happens to make water molecules vibrate which causes friction which causes heat.

At least shes not a flat Earther.