>>8865286 FDA allows Novartis to test hydroxychloroquine against COVID-19
WARNING to POTUS/Qteam RE Big Pharma Trials on HCQ
PharmaR&D fag here. Qteam should be aware that Big Pharma companies like Novartis are masters of clinical trial sabotage especially if a negative trial result benefits their current investments. For example, if Novartis or its affiliate companies already have a COVID19 vaccine and/or expensive small molecule antiviral therapeutic in the pipeline for COVID19, getting a positive trial result and FDA approval of HCQ will undermine their future ROI. Because HCQ is a generic for which no use patent currently exists for COVID19, it is impossible to make this a "blockbuster" monopoly drug. FDA approval of a common generic drug with no patent protection would allow any generic HCQ manufacturer to market the drug under Novartis's NDA. Their stockholders will NEVER allow this to happen.
Therefore, there is a very high probability that this Phase III trial will be designed to fail. How? Easy. For example, by employing high doses known to cause adverse events, recruiting patients with preexisting cardiovascular risks, or who are chronically ill or elderly patients who are already hospitalized and who are unlikely to benefit the most. Remember, it only takes a couple of patients to have severe adverse events or die for the company to halt the trial and claim that the drug is too dangerous to proceed with further testing.
There are numerous examples of such botched trials in the literature if you know what to look for, but some examples include clinical trials on omega3 fatty acids (fish oil) for cardiovascular disease, vitamin E for cardiovascular disease, Niacin for hyperlipidemia, etc. all funded by drug companies where a positive outcome would not benefit their share holders.
For example, Niacin (vitamin B3) was the "gold standard" in treating hyperlipidemia and heart disease for decades, being one of the only "drugs" known to increase HDL (good cholesterol). Numerous clinical trials over the years demonstrated that this cheap and effective treatment reduced all cause mortality by several years. This was a huge problem for Big Pharma who wanted to exploit this potential market, so they had to figure out a way to tarnish Niacin's long held reputation among doctors. So what Merck did was to combine Niacin with one of their own drugs, which had already failed to get FDA approval in a trial with patients who already had low LDL levels. Predictably, the trial failed and actually increased the risk of stroke. The findings were then used in a vast media campaign to tarnish the reputation of this old cheap and effective drug. Novartis will do exactly the same thing to HCQ if giving the opportunity, which appears to be the case.
https://www.npr.org/blogs/health/2012/12/20/167713438/merck-undercuts-popular-notion-that-niacin-prevents-heart-attacks