I have no idea. Searching for “deaths in clinical trials” returns alarming hits.
Clinical Trials Do Go Wrong: How Many Human Subjects Are Injured By Scientific Research Each Year? “No one knows…”
Clinical trial disasters (Wikipedia category)
Top 10 Clinical Trials That Went Horribly Wrong
Haphazard reporting of deaths in clinical trials: A review of cases…
Over 24,000 clinical trial deaths and SAEs [serious adverse events] in India in ten years
A hydroxychloroquine trial just bit the dust over participants developing irregular heartbeats:
I worked for several years in pharmaceutical research. It happens. It’s bad, and may cause the drug trials to end. I say “may” because it’s one of those things where you have to balance the severity of the issue you’re solving for versus the dangers of the drug. So a cancer drug may continue, Hepatitis and certain heart medications have continued, but something to combat hay fever would be shut down immediately.
Yes, there are over 70 vaccines in the works already. 3 of them are in the stage 2 human testing phase. When those are complete they go to stage 3 with a higher number of people being tested.
With that said I don’t know the timeline of stage 2 and stage 3 testing or if there is any red tape that slows it down.
According to your cite it was the drug chloroquine in the trial.
A small study in Brazil was halted early for safety reasons after coronavirus patients taking a higher dose of chloroquine developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia.
Patients in the trial were also given the antibiotic azithromycin, which carries the same heart risk.
So to clarify, this was a small study using different drug than the one you referenced, at a higher dose, given with another drug known for the same heart risk.
You might consider that there are other countries out there using it with some level of success. The actual drug you listed has been around for a very long time and it’s dosage and side affects are known.
Yes, we know it has some pretty bad side effects. I would risk covid-19 rather than a steady dose of hydroxychloroquine. Not even a question.
From the cite:
I’d say a ~14% death rate is an “increased risk”. Extrapolate that to dosing-up 330 million Americans. ~45 million die. There goes the Deep South. :eek:
Not really. That was 81 patients who already had COVID-19, and were hospitalized. Presumedly, some of them would have died anyway. Testing the drug on them was one thing. Their risk of dying was already high.
Giving it prophylactically to 330,000,000 adults and children, most uninfected, and few recovered, many with no risk factors for a bad infection. Their risk of eventually contracting it, then having a bad case, then dying from it, was non-zero, but not high enough for prophylactic use of the drug.
However, it is probably possible to calculate whose risk, even in semi-quarantine, is high enough that it is worth the risk of the drug-- say, a necessary worker who can’t fully work from home, and must go in twice a week, and be around everyone, while having diabetes, heart disease, and asthma. That is someone who might choose to take the drugs prophylactically…
In the movie the Martian they decided to cut some red tape. For those that did not see it, they skipped some tests and the rocket blew up.
Interesting tangent: Barry Marshall, Nobel Prize in in Physiology or Medicine, “drank a broth containing cultured H. pylori” … “This experiment was published in 1985 in the Medical Journal of Australia and is among the most cited articles from the journal.” (Wikipedia).
No, we don’t know it has some pretty bad side effects. It’s been used successfully since the 50’s. the study I questioned involved long term high doses of a different drug versus low doses of hydroxychloroquine over a short period of time.
For clarification, I’m not saying we ***should ***skip clinical trials and certification and all that. I’m just asking, if we *did *eliminate it, what’s the fastest/soonest that the pharmaceutical labs could pump vaccines out.
You don’t.
Vaccines for dengue and rotavirus have been withdrawn because it was discovered that people who got those vaccines, and were later exposed to those viruses, got sicker than those who didn’t!
That red tape was not about its use for morning sickness, but instead one of the side effects experienced by long-term users - peripheral neuropathy, and specifically people who lost the use of their thumbs. Some of those turned out to be permanent, and it’s still a risk people take when they take it for multiple myeloma (this happened to Geraldine Ferraro) or Hansen’s disease, aka leprosy.
It takes time for the labs to setup production. Different vaccines are made different ways. The flu vaccine is produced in eggs. It takes time for eggs to produce the virus, and the virus to be harvested, inactivated, and turned into a vaccine. That’s a process that we’ve been doing for 70 years or so. There are lots of other ways to make vaccines. The stuff I’ve heard says months to years to get manufacturing running. Part of the accelerated plan is to debug manufacturing problems while the vaccine is in clinical trials. Multitasking. If it fails in clinical trials, then the manufacturing work might have been wasted (unless it can be applied to another vaccine candidate), but it is a reasonable gamble to take to get something as fast as possible.
The clinical trials are the fundamental step that takes some potion and determines that it is useful as a vaccine. Until then it’s just a bunch of stuff some people in a lab mixed together. Do you want to inject that? May as well use elderberries or essential oils. How long would it take to build a car if all those pieces didn’t have to be welded and bolted together and stuff?
Developing some vaccines means culturing the virus in a medium. Animals are frequently used. The length of time to produce a vaccine can depend on the life cycle of the animal.
Flu vaccines come from chicken eggs.
At least one vaccine is developed from horses.
Vaccines are a fascinating topic. There are many ways to create them; this is not a one size fits all process.
~VOW
You mean the red tape of testing the consequences of the drug? See how well that worked with Thalidomide.
they could do it right now as a theoretical answer to your question. But as we know, people react differently to the same drug.
Some people have severe reactions to the tiniest amount of peanuts. Some people do very poorly with gluten. Anti-viral drugs are drugs that train the immune system to react to a virus. If the immune reacts poorly then the body may end up attacking itself.
It might be possible to accelerate stage 2 and 3 testing with more people but it increases the risk to those people.
The way to get a good trial of a vaccine very quickly is to get a bunch of experimental subjects, vaccinate half of them with your trial vaccine, and then expose all of them to the pathogen. Oh, and then kill a lot of them and autopsy to look for signs of damage from the pathogen and/or the vaccine. This is one reason it’s easier to develop veterinary vaccines than ones for humans. It’s hard to find humans to volunteer for those trials.
But your question still assumes that you can make a vaccine without those steps. How can you say you have a “Covid-19 vaccine that works” if you don’t know anything about its quality or if it’s even safe to use?