Wednesday, February 03, 2021

Randomized Controlled Trials and Covid-19

 Usually drug trial are divided in four phases:

 - (optional: phase 0): initial studies in animals and low doses for humans

 - phase 1: basic exploration. How does the medicine work? Is it safe? What dose is optimal?

 - phase 2: small scale test (25-100 patiënts): does it work?

 - phase 3: in a Randomized Controlled Trial the medicine is compared to placebos or existing products.

With the corona epidemic only phase 3 studies are done. The excuse is that we are in an emergency and that speed is essential. 

Sounds reasonable. Problem is that even if it results in a workable solution it may not be the optimal solution. We saw that illustrated when AstraZenica accidentally found that giving half a dose in the first round worked better. It may very well be that doses for other vaccines are far from optimal too. And although the claims of 90+% effectiveness for some vaccines may seem to leave little room for improvement both their need for a second dosage and their considerable side effects suggest otherwise.

The New York Times published an article "How the Search for Covid-19 Treatments Faltered While Vaccines Sped Ahead". According to the article:

The government poured $18.5 billion into vaccines, a strategy that resulted in at least five effective products at record-shattering speed. But its investment in drugs was far smaller, about $8.2 billion, most of which went to just a few candidates, such as monoclonal antibodies. Studies of other drugs were poorly organized.

But even given the 8 billion dollar expenditure, the results are very meager. Seeing how promising treatments like HCQ and Ivermectin are maltreated one has to wonder whether other motives play a role. Robert F. Kennedy, Jr. suggests that the interests of the vaccine producers play a role. If there is a medicine against Covid-19 it would no longer be possible to approve the vaccines according to the emergency rules.

What also plays a role that - given the absence of independent government institutes (many government paid experts have strong ties with the pharmaceutical industry) - it is hard to get the high volume research that would take away all doubts.

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