8 ms·

Unlikely. It has done this with US$290 million—about one-quarter of what a typical pharmaceutical company would spend to develop just one drug. The mod

Unlikely. It has done this with US$290 million—about one-quarter of what a typical pharmaceutical company would spend to develop just one drug. The model for its success is the product development partnership (PDP), a style of non-profit organization that became popular in the early 2000s. PDPs keep costs down through collaboration—with universities, governments and the pharmaceutical industry. So, was the $290 million the total amount for all 26 trials? Or did the collaborators kick in money? Because otherwise this is like claiming you've found a way to buy a new Tesla for $1000-- as long as your parents pay the other $69,000! Drug development from scratch is arduous and expensive. It begins with experiments on hundreds of thousands of chemicals in the lab, looking for one that kills a pathogen without harming the host. The article does not go out of its way to mention that this isn't the expensive and arduous part. The clinical trials are what's expensive, since you have to pay thousands of people, who have the disease you're targeting, to take your experimental drug. In many cases, they have to take your drug instead of a drug that's known to work. And you have to follow these people for years, just in case they don't all suddenly get liver cancer and die a year after they stop taking your drug. (Something like this cost Merck $4.85 billion dollars in 2004: https://en.wikipedia.org/wiki/Rofecoxib https://en.wikipedia.org/wiki/Rofecoxib ) The final trials on fexinidazole conclude this year, and Wourgaft is hopeful that the data will earn regulators' stamp of approval. The project has so far cost the DNDi about $45 million—and it stands to help 21 million people at risk of the disease in Africa. Which regulators? There is a rather huge difference between the FDA and the Central African Republic's FDA-equivalent. Is this how they're saving money on clinical trials, by running clinical trials on Africans, and only getting regulatory approval from African states?

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."
  - 10y ago
zubairq 10y ago
I totally agree. I work at Novo Nordisk and the trials are the expensive part!
refurb 10y ago
The clinical trials are what's expensive, since you have to pay thousands of people, who have the disease you're targeting, to take your experimental drug. You raise a great point. I was talking to a CRO (contract research organization - often hired to run clinical trials) and the rule of thumb is that a phase 3 trial will cost ~$10K to $15K per patient per year. It all depends on how involved the endpoint measurements are. A simple blood test pushes it to the lower part of that range and something more involved like an MRI might push it to the top (or higher). That doesn't seem bad until you start to look at the size and duration of trials. If you're coming up with a new heart disease drug, the FDA often requires a multi-year trial and 5K to 10K patients in each trial (two phase 3 trial are required by the FDA, generally). So if you're running two 10,000 patient trials that last 2 years, your phase 3 bill is already $300M. And that doesn't include all the other costs that come with bringing a new drug to market. Now that is the higher end. Oncology clinical trials or trials for orphan diseases can push that number down to 1/10th or ~$30M.
- deleted 10y ago
  [deleted]

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."
- 10y ago

zubairq 10y ago

I totally agree. I work at Novo Nordisk and the trials are the expensive part!

refurb 10y ago

The clinical trials are what's expensive, since you have to pay thousands of people, who have the disease you're targeting, to take your experimental drug. You raise a great point. I was talking to a CRO (contract research organization - often hired to run clinical trials) and the rule of thumb is that a phase 3 trial will cost ~$10K to $15K per patient per year. It all depends on how involved the endpoint measurements are. A simple blood test pushes it to the lower part of that range and something more involved like an MRI might push it to the top (or higher). That doesn't seem bad until you start to look at the size and duration of trials. If you're coming up with a new heart disease drug, the FDA often requires a multi-year trial and 5K to 10K patients in each trial (two phase 3 trial are required by the FDA, generally). So if you're running two 10,000 patient trials that last 2 years, your phase 3 bill is already $300M. And that doesn't include all the other costs that come with bringing a new drug to market. Now that is the higher end. Oncology clinical trials or trials for orphan diseases can push that number down to 1/10th or ~$30M.

deleted 10y ago
[deleted]