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posted by martyb on Saturday May 02 2020, @09:12PM   Printer-friendly
from the festina-lente dept.

With a major pandemic sweeping the world, the standard process of clinical trials for drug approval has come under criticism as a needless source of bureaucracy and delay. Drug discovery chemist Derek Lowe in a blog post explains how clinical trials for drug approval work and the reasons behind the various requirements that the FDA and equivalent organisations around the world generally put in place before approving a new drug. He explains how most of these apparently pointless bureaucratic hurdles are actually there to help protect the integrity of the scientific process and ensure that the human subjects undergoing the trials are treated ethically. While a case can be made for relaxing some of these safeguards, especially in this time of pandemic, it is probably not a good idea to do so without at least understanding what these safeguards are for.

Determining how much of a pharmaceutical is needed to prepare for the trial. Ensuring your are actually preparing just that drug and not a polymorph. Proper laboratory and manufacturing practices to ensure the desired drug is actually prepared without impurities and contaminants. Preparing a plan for a drug trial. Demographics — age, gender, weight, current medications being taken. Getting a representative distribution of these as participants. And there's much more.


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  • (Score: 2, Interesting) by anubi on Sunday May 03 2020, @01:11AM (9 children)

    by anubi (2828) on Sunday May 03 2020, @01:11AM (#989656) Journal

    You have a crude way of saying it, but invariably, herd immunity or tolerance will be the final outcome.

    If it didn't, leprosy would have eventually wiped out the whole human race. Or that Covid19 would have completely wiped out those Chinese bats who supposedly gave it to us.

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    "Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
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  • (Score: 2, Informative) by Anonymous Coward on Sunday May 03 2020, @03:18AM

    by Anonymous Coward on Sunday May 03 2020, @03:18AM (#989687)

    leprosy takes 20+ years to start presenting symptoms. and it is relatively hard to get in the first place. it has never reached epidemic status, even though it is still endemic in some regions.

  • (Score: 3, Insightful) by JoeMerchant on Sunday May 03 2020, @04:07AM (7 children)

    by JoeMerchant (3937) on Sunday May 03 2020, @04:07AM (#989694)

    Part of why it spreads so well is that a very large percentage of us already have immunity/tolerance - it's turning most of the people it infects into "Typhoid Marys."

    Latest numbers I've heard are 63,000 dead in the US, that's somewhere around 0.02% of the population, and I have a hard time believing that our present total infected level is less than 0.5%. In other words: I believe the overall death rate is pretty far below the 3.4% level that I've seen quoted. Which is fine, people wouldn't take it seriously if you told them the overall death rate after infection was 0.1%, and below age 70 was 0.01%, and the whole "curve flattening" thing wouldn't work.

    --
    🌻🌻 [google.com]
    • (Score: 1, Interesting) by Anonymous Coward on Sunday May 03 2020, @06:33AM (2 children)

      by Anonymous Coward on Sunday May 03 2020, @06:33AM (#989704)

      Viruses usually evolve to be less lethal due to the selective pressures on them. Last I checked, the various clades already have drastically differing mortality rates. They are also not distributed geographically in an even fashion, which is part of the reason why death rates are so different. It wouldn't be too surprising if those less-lethal strains are dragging the overall mortality rate down. Either way, the phylogenetic analysis will be interesting.

      • (Score: 2) by hendrikboom on Sunday May 03 2020, @04:07PM (1 child)

        by hendrikboom (1125) Subscriber Badge on Sunday May 03 2020, @04:07PM (#989823) Homepage Journal

        We can hope that immunity against the less-lethal strains confers immunity against the more lethal strains.

        • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @08:40PM

          by Anonymous Coward on Sunday May 03 2020, @08:40PM (#989894)

          It should. It is the major reason the Pandemic Flu disappeared.

    • (Score: 1, Informative) by Anonymous Coward on Sunday May 03 2020, @08:29AM (1 child)

      by Anonymous Coward on Sunday May 03 2020, @08:29AM (#989722)
      Which still translates to hundreds of thousands to millions of deaths if business is allowed to proceed as usual.
      • (Score: 2) by JoeMerchant on Sunday May 03 2020, @12:37PM

        by JoeMerchant (3937) on Sunday May 03 2020, @12:37PM (#989767)

        Which still translates to hundreds of thousands to millions of deaths if business is allowed to proceed as usual.

        Absolutely, and we should take measures to prevent that. Hell, we should also have taken stronger measures to prevent the million+ deaths caused by Gulf War II. It's just a shame that you have to lie to the general population to get them to react in an appropriate manner.

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        🌻🌻 [google.com]
    • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @11:46AM (1 child)

      by Anonymous Coward on Sunday May 03 2020, @11:46AM (#989753)

      whole "curve flattening" thing wouldn't work.

      Seems to work here in Germany.

      • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @02:36PM

        by Anonymous Coward on Sunday May 03 2020, @02:36PM (#989807)

        We know that Germany is reporting the underlying condition as the cause of death even if a person is infected, and that in the US we are reporting covid as the cause of death even if the person has an underlying condition. I spent some time yesterday trying to figure out Canada's death criteria but couldn't find it. Anyway, the point is, all these numbers being thrown around are just numbers and may not be all that comparable and whether Germany has or has not flattened the curve is hard to know.