4 ms·

Running unregulated clinical trials in impoverished nations is demonized and illegal when done by big pharma, but championed when done by some little company "t

by daxfohl 10y ago

Running unregulated clinical trials in impoverished nations is demonized and illegal when done by big pharma, but championed when done by some little company "trying to make a difference". I like the ideal but so much of this seems like marketing. Granted, motivation makes a big difference here. However it's often hard to tell profit motive from innate motive, especially in a legal context. What starts off as innate can quickly become profit-oriented (or even worse "I told you so"-oriented) behind closed doors when stuff hits the fan.

jedmeyers 10y ago
> I like the ideal but so much of this seems like marketing. Running unregulated clinical trials in impoverished nations makes a corporate comeback.
sandworm101 10y ago
>> unregulated clinical trials in impoverished nations is demonized It is, but regulated trials in such countries have real scientific advantages. The average US patient (older, overweight, probably diabetic) swims in a cocktail of drugs ranging from painkillers[1] to cholesterol reducers. By some estimates 60% of American adults are on one or more prescription drugs, a percentage that no doubt climbs with age. That makes them difficult guinea pigs for the study of new treatments. But the average African cannot afford such cocktails and so is most likely clean of other drugs. Costs and poverty aside, if you are looking for a drug-free study population, Africa is easier than the west. [1] "In 2010, enough prescription painkillers were prescribed to medicate every american adult every 4 hours for 1 month." https://www.drugabuse.gov/related-topics/trends-statistics/infographics/popping-pills-prescription-drug-abuse-in-america https://www.drugabuse.gov/related-topics/trends-statistics/i...
- arkades 10y ago
  That's the opposite of a real scientific advantage. Most drug effectiveness is related to the population in which it is deployed, based on their combination of unique risk factors and etiologies. Socioeconomic factors (and I mean that in its accurate usage, not just a short-hand for "income") are a huge example: they're one of the biggest predictors of health outcomes and responsiveness to various treatments, and using a population with wildly different SES factors fundamentally kills the trial. A sample population which accurately reflects the general population in which a drug is to be deployed is assessed, in clinical trials, as something known as "external validity" (as opposed to "internal validity", which is just whether the experiment is properly designed to test its stated hypothesis). tl;dr apparent drug effects in Africans are not useful indicators of drug effects in Americans, particularly if your premise is "those drugs have different outcomes in Americans."
- Thriptic 10y ago
  It's not important that the medication works on an ideal population, it's important that it works on the actual target population. If you can't show efficacy and safety in your target population who may have several comorbidities and could be taking many other drugs which may interact poorly with your drug, then your drug is a failure in the real world. It therefore is not sensible to test for safety and efficacy on a population that poorly mirrors your target population.
  - pixl97 10y ago
    Eh, it's both. You need a baseline for any testing. When testing physical equipment with a difficult to diagnose problems the easiest way to figure out what is going on is to take the hardware down to a base state and then add one component at a time to see where things go wrong. When you have one population that is positively effected by your drug and takes no other medications it gives a great deal of insight when another population is negatively effected that is highly medicated. We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. With the huge amount of medications taken we need the baseline to tell doctors to stop giving patients drugs X, Y, and Z because they would be much better off only taking A.
    - refurb 10y ago
      We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. That's a huge exaggeration. There are maybe a handful of drugs where the side effects/interactions are so bad that they wouldn't be approved by today's FDA.
  - sandworm101 10y ago
    To get to the "does it work" or "is it worth it" questions one has to first determine what it actually does, what effects the drug has on the human body. For that you want to start with a neutral test subject. As others have said, many drug studies are looking for a degree of effect, whether the drug out performs some other drug already in use. For such comparisons you need a baseline effect. The US population's drug consumption, while certainly the eventual market, is a shifting target. If you want a common baseline for comparisons, the easiest is a drug-free test subject. Also, drugs are tested on groups but administered to individuals. A prescribing doc needs to know the effect absent any other drug interactions. Having a patient stop taking other drugs is always an option. So you need an understanding of how the drug operates under ideal conditions and in the presence of other drugs. Prescriptions remain an individualised medical choice.
landryraccoon 10y ago
Note that this is a nonprofit, not a company. There is no big exit for founders or profit motive at work here.
- drakonandor 10y ago
  Nevertheless, many non-profits have hefty salaries and pensions.

by daxfohl 10y ago

jedmeyers 10y ago

> I like the ideal but so much of this seems like marketing. Running unregulated clinical trials in impoverished nations makes a corporate comeback.

sandworm101 10y ago

>> unregulated clinical trials in impoverished nations is demonized It is, but regulated trials in such countries have real scientific advantages. The average US patient (older, overweight, probably diabetic) swims in a cocktail of drugs ranging from painkillers[1] to cholesterol reducers. By some estimates 60% of American adults are on one or more prescription drugs, a percentage that no doubt climbs with age. That makes them difficult guinea pigs for the study of new treatments. But the average African cannot afford such cocktails and so is most likely clean of other drugs. Costs and poverty aside, if you are looking for a drug-free study population, Africa is easier than the west. [1] "In 2010, enough prescription painkillers were prescribed to medicate every american adult every 4 hours for 1 month." https://www.drugabuse.gov/related-topics/trends-statistics/infographics/popping-pills-prescription-drug-abuse-in-america https://www.drugabuse.gov/related-topics/trends-statistics/i...

arkades 10y ago
That's the opposite of a real scientific advantage. Most drug effectiveness is related to the population in which it is deployed, based on their combination of unique risk factors and etiologies. Socioeconomic factors (and I mean that in its accurate usage, not just a short-hand for "income") are a huge example: they're one of the biggest predictors of health outcomes and responsiveness to various treatments, and using a population with wildly different SES factors fundamentally kills the trial. A sample population which accurately reflects the general population in which a drug is to be deployed is assessed, in clinical trials, as something known as "external validity" (as opposed to "internal validity", which is just whether the experiment is properly designed to test its stated hypothesis). tl;dr apparent drug effects in Africans are not useful indicators of drug effects in Americans, particularly if your premise is "those drugs have different outcomes in Americans."
Thriptic 10y ago
It's not important that the medication works on an ideal population, it's important that it works on the actual target population. If you can't show efficacy and safety in your target population who may have several comorbidities and could be taking many other drugs which may interact poorly with your drug, then your drug is a failure in the real world. It therefore is not sensible to test for safety and efficacy on a population that poorly mirrors your target population.
- pixl97 10y ago
  Eh, it's both. You need a baseline for any testing. When testing physical equipment with a difficult to diagnose problems the easiest way to figure out what is going on is to take the hardware down to a base state and then add one component at a time to see where things go wrong. When you have one population that is positively effected by your drug and takes no other medications it gives a great deal of insight when another population is negatively effected that is highly medicated. We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. With the huge amount of medications taken we need the baseline to tell doctors to stop giving patients drugs X, Y, and Z because they would be much better off only taking A.
  - refurb 10y ago
    We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. That's a huge exaggeration. There are maybe a handful of drugs where the side effects/interactions are so bad that they wouldn't be approved by today's FDA.
- sandworm101 10y ago
  To get to the "does it work" or "is it worth it" questions one has to first determine what it actually does, what effects the drug has on the human body. For that you want to start with a neutral test subject. As others have said, many drug studies are looking for a degree of effect, whether the drug out performs some other drug already in use. For such comparisons you need a baseline effect. The US population's drug consumption, while certainly the eventual market, is a shifting target. If you want a common baseline for comparisons, the easiest is a drug-free test subject. Also, drugs are tested on groups but administered to individuals. A prescribing doc needs to know the effect absent any other drug interactions. Having a patient stop taking other drugs is always an option. So you need an understanding of how the drug operates under ideal conditions and in the presence of other drugs. Prescriptions remain an individualised medical choice.

landryraccoon 10y ago

Note that this is a nonprofit, not a company. There is no big exit for founders or profit motive at work here.

drakonandor 10y ago
Nevertheless, many non-profits have hefty salaries and pensions.