As someone who has been on the corporate side of this type of debate, I can assure you that Gilead has several magnitudes of more information about both of these molecules than the author has.
And as others have mentioned, the only data for the alternative molecule is animal data versus remdesivir which already has phase 3 data. Sure, the other drug might be better, but it might not work at all.
Sure, and that can include unpublished negative data.
Ben Goldacre (a Senior Clinical Research Fellow at the Centre for Evidence Based Medicine in the Department of Primary Care in the University of Oxford{0}), wrote in his book Bad Pharma, about an instance where a specific subset of SSRIs were given to eight(?) year olds for clinical depression. What the GPs prescribing them didn't know, however, was that the suicide rate for those children would go up after prescription. The pharmaceutical company knew about this. It was a negative result, and was unpublished.
Pharmaceutical companies' only duty is to turn a profit to their shareholders. If they spend five or ten years developing a drug that they find has either no or negative use, then in the eyes of the shareholders, they have wasted that money. The duty of the company is to find a use for the drug regardless of whether it is useful or not, regardless of whether there is a more beneficial alternative.
I’m not sure your example of increased risk of suicide is a good one - the FDA already responded to that data and increases warnings. Sounds like the system worked.
This is a pretty good paper that covers the issue. It wasn't that straightforward to actually get reliable data and the author here is arguing that the pendulum swung too far - adolescents weren't get antidepressants because doctors were so scared of the boxed warning the FDA added.[1]
And there is likely a bit of 20/20 hindsight going on here. Clinical trial is never black and white. You can get “signals” in the data that aren’t real, especially if the trial wasn’t powered well enough.
If we pulled drugs from the market every time someone found a signal, we’d probably have 10% of the drugs we do now, and people would be denied any benefit.
Drug development is all about risk versus benefit, and yes, the FDA is willing to approve a drug with significant risks if the drug is treating a serious disease.
As a contrast, and since you've mentioned Good Pharma, I suggest reading also "Bottle of Lies: The Inside Story of the Generic Drug Boom" ( https://www.amazon.com/dp/0062338781/ )
This book discusses the supply line of generic drugs on US shelves today.
This is exactly why Gilead won’t allow the similar drug to be used in cats. They don’t want to know about negative side effects that might then hinder the drug’s approval for use in humans.
If ever there has been a business decision to illustrate the whole “putting profits over people” this is it. And sunk costs, too.
Where are you getting this from? The only mention of cats in the article is actual data of the drug in cats.
When GS-441524 was used to treat cats with feline infectious peritonitis, a progressive and usually fatal disease caused by a coronavirus, it displayed remarkable safety and therapeutic efficacy, with 96% of cats recovering after treatment.
> They don’t want to know about negative side effects that might then hinder the drug’s approval for use in humans.
This argument actually threw me for a loop. Now I'm concerned about all the other drugs that the cats didn't use first. It must be the one major missing protocol from our vastly successful drug regulation system. /s
There are a ton of studies that show side effects in non-human animals are not a good predictor of side effects in humans; and this becomes more true with rarer side effects.
There is not good correlation of side effects between different animals and failures in phase 1 studies often show that safety data in animals did not predict side effects in humans that became apparent in very small human populations.
So, widespread use in animals can actually harm humans by bubbling up side effects that are not relevant to humans.
Among some safety people, there is even a question of whether there are drugs shelved for animal side effects that would be 100% safe in humans. But if a drug killed half your rats, you cannot ethically start dosing humans with it.
The book “Medical Nihilism” by Jacob Stegenga similarly covers the subject of hiding negative results, how even apparently carefully performed double-blind studies can be manipulated to favor pharmaceutical companies and how those companies “invent” deceases to get more prescriptions of their drugs.
None of that really addresses the public health policy question of what to do about drugs/compounds that are identified as strong candidate treatments.
> As someone who has been on the corporate side of this type of debate, I can assure you that Gilead has several magnitudes of more information about both of these molecules than the author has.
Which is a neverending scandal that should outrage everyone.
Yeah, that’s almost certainly true. But it’s human nature to second-guess organizations that should know what they’re doing, and it makes for a fun mental diversion.
And as others have mentioned, the only data for the alternative molecule is animal data versus remdesivir which already has phase 3 data. Sure, the other drug might be better, but it might not work at all.