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Exposing Pharma's playbook - Part 1

Fudging Clinical Trials
6

In the video above, Aseem sheds light on two tactics employed by Big Pharma to manipulate clinical trials, making drugs appear more effective than they truly are while minimizing the reported side effects. Let me elaborate further on this issue, and add a few more tactics used by Big Pharma!

False Endpoint Selection

The first thing that Aseem mentioned was the "False Endpoint" selection.

Endpoint selection is a crucial aspect of clinical trials, as it determines the specific goals or outcomes that researchers will measure to evaluate the effectiveness and safety of a drug. By carefully selecting the endpoints, Big Pharma can manipulate the results to make their drugs appear more favourable.

There are two main types of endpoints: primary and secondary. The primary endpoint is the main outcome that a study is designed to assess. Secondary endpoints, on the other hand, are different outcomes that researchers will also measure, but they're not the main focus of the study.

Here's where it gets interesting: Big Pharma can carefully pick primary and secondary endpoints to make their drug appear more effective or minimize potential side effects.

Imagine this; they've got this new drug called "SuperRelaxDeluxe(™)" that's supposed to help you unwind after a long day. Of course, they could be honest and set a primary endpoint like "reduces stress levels by 50%," but that's not as easy. So instead, they go for something like "makes you feel 10% more relaxed within 30 minutes," which sounds pretty good, but it's not quite the same as being genuinely stress-free, right?

Endpoint selection is a powerful tool that Big Pharma can use to manipulate the results of clinical trials and shape public perception of their drugs. By carefully choosing primary and secondary endpoints, they can create a favourable image for their products, even if the real-world benefits are less impressive or come with significant risks.

This could be why it was unexpectedly revealed that the experimental vaccines were not evaluated for their impact on transmission. It's possible that the vaccines didn't perform well in that aspect, leading to the decision to abandon that part of the trial and focus on other secondary endpoints instead.

Now, what if they fail both primary and secondary endpoints???

Data Dredging

You see, clinical trials generate a whole bunch of data, and sometimes, things go differently than planned. Maybe the drug isn't as effective as they'd hoped, or the side effects are a bit more gnarly than expected. But fear not, Big Pharma's got their trusty data dredging pan, and they're ready to sift through the numbers to find those golden nuggets of positivity.

Not wanting to give up on their potential moneymaker, they decide to dig deep into the data to find any glimmer of hope. And bingo! They notice that among a small group of participants who happen to be left-handed, live in the countryside, and own at least three cats, there's a remarkable decrease in stress levels after taking SuperRelaxDeluxe(™).

So Big Pharma pounces on this niche discovery and starts marketing SuperRelaxDeluxe as the ultimate stress reliever for left-handed, rural-dwelling cat lovers. They even throw in a catchy slogan, like "SuperRelaxDeluxe(™): The perfect solution for lefties and their kitties!"

Pre-randomization Selection Phase

The second thing that Aseem mentioned is the pre-randomization of samples.

It's basically when they're selecting the participants for the study, and this is where Big Pharma gets crafty. They cherry-pick the healthiest individuals who are least likely to experience side effects from the drug being tested. So, they're really going for the A-team here, people who are perfect specimens of health.

What about those who might be more prone to experiencing side effects? Well, Big Pharma makes sure to weed them out before the trial even kicks off. It's like they're throwing a super exclusive party and handpicking the guest list to ensure everything goes off without a hitch.

By doing this, they can paint a pretty picture of their drugs, making them seem like miracle workers without any downsides. It's all about crafting that perfect image, right?

Ghostwriting

Another method that Big Pharma uses is called Ghostwriting.

Basically, ghostwriting is when a big pharma company hires a professional writer to create a scientific article or manuscript, and then they slap the name of a well-respected doctor or researcher. By attaching a reputable name to their research, they can increase their credibility and influence in the industry, which can help them sell more drugs.

Ghostwriting is not new in the industry, but the trick is not getting caught. Pfizer got caught once with Neurontin and slapped with a $430 million fine for engaging in ghostwriting practices to promote the off-label use of Neurontin (gabapentin), an antiepileptic drug, for various indications such as bipolar disorder and neuropathic pain. The company hired a medical writing agency, which produced articles published in medical journals under the names of respected researchers. [SOURCE]

Neurontin generated $2-3 billion in annual sales and was hit with a hefty one-time fine of $430 million. Perhaps Pfizer was viewing it as just another cost of doing business, or as we say in the business world, a small price to pay for being at the top of the game. The experimental mRNA brought in a whopping $37 billion in 2022 alone. Who knows, they may end up getting hit with a fine too. Would it be sufficient to stop their business practices?

Signing off for now
-Aussie17

(Part 2 incoming)

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