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In its report, the WHO team agreed that the concept of RISUG was intriguing. But they found fault with the homegrown production methods: Guha and his staff made

In its report, the WHO team agreed that the concept of RISUG was intriguing. But they found fault with the homegrown production methods: Guha and his staff made the concoction themselves in his lab, and the WHO delegation found his facilities wanting by modern pharmaceutical manufacturing standards. Furthermore, they found that Guha’s studies did not meet “international regulatory requirements” for new drug approval—certain data was missing. The final recommendation: WHO should pass on RISUG. Is this an example of why health care is so incredibly expensive in this country? Do these "modern pharmaceutical manufacturing standards" actually buy us extra safety?

zemaj 15y ago
This process may be a preferable alternative to condoms, but it does not stop the spread of STDs. From the WHOs perspective there's no obvious benefit. I suspect this may be the real cause of their lack of interest.
pyre 15y ago
> Do these "modern pharmaceutical manufacturing standards" actually buy us > extra safety? They certainly buy us jobs for bureaucrats. Recently the FDA confiscated all of the birthing pools (related to the surge in popularity of water births). Apparently inflatable pools should be classified as 'medical devices.' To quote the FDA, "pregnacy is an illness and birth is a medical procedure."
- towelrod 15y ago
  Do you have a source for that quote?
  - pyre 15y ago
    * http://blog.cuntastic.org/2011/05/26/birth-pools-seized-by-fda-in-portland-or/ http://blog.cuntastic.org/2011/05/26/birth-pools-seized-by-f... * http://blog.cuntastic.org/2011/05/27/interview-with-barbara-harper/ http://blog.cuntastic.org/2011/05/27/interview-with-barbara-...
jacoblyles 15y ago
Regulation costs account for 90% of bringing a drug to market, on average $1 billion and 10 years of clinical trials for each new drug [1]. Of course, a mere 10 years of clinical trial cannot catch all long-term side effects, and we would be safer if the FDA was more stringent. The flip side is that we would have fewer and more expensive health care options. For better or worse, our regulatory structure is heavily biased towards fewer deaths from approved treatments, very long clinical trials, and expensive health care. In general, the word "agile" and the health industry have nothing to do with each other. [1] yeah, yeah, citation needed. I pick facts up by listening to The Economist podcast on the way home, you go find a hyperlink.
pavel_lishin 15y ago
I'm sure it's not as black and white as that. There's a certain level of safety requirements, and we could probably relax them with only a small percentage of people suffering or dying as a result. We could also raise them, and decrease that number. Etc, etc., it's all a numbers game, and I'm already boring myself with this argument.
Sukotto 15y ago
Do these "modern pharmaceutical manufacturing standards" actually buy us extra safety? Yes, but we pay a price: * Evaluations take a really long time. So it's hard to get the drugs into the hands of people. * Development is now extremely expensive. That forces just about everyone except the largest drug mega-corporations out of the market. * Drugs that would be a net benefit to the world sometimes never make it through the entire process because the ROI isn't good enough, or the associated side effects are deemed too harsh. (We would likely not have aspirin today if it hadn't been developed prior to the modern way of drug development... it has too many high-risk side effects) -- On the plus side: * The drugs you do get are generally far safer and better understood than they otherwise would be * You can feel safe that each batch of the drug was made the same way, using the same process, and ends up having the same strength/effectiveness as every other batch of the same drug... even when made by a different company. (We take that for granted now... but it's actually a really big deal if you look at medication from a historical perspective.) * We have far fewer snake-oil salesmen ripping people off for cures that are, at best, useless and at worst, cause the condition to get worse, or cause birth defects, or some other harm. If we do find the drug doing harm, it gets pulled off the market
- jonprins 15y ago
  "We also have far fewer snake-oil salesmen ripping people off for cures" Yet we still have chiropractors and homeopathy.
  - cwp 15y ago
    Two weeks ago I went to see a chiropractor. I was in so much pain I could barely walk, and my lower back wouldn't flex enough for me to stand up straight. She thought I probably had a pulled muscle. She stretched my legs and hips, twisted my spine a bit and showed me some stretches that I could do at home. I left feeling a bit sore, but otherwise fine. It took 20 minutes and cost me $60. It might not be medicine, but it's not snake-oil either.
  - sorbus 15y ago
    Sadly, they get around all the regulation by not making specific medical claims. If they did, then regulation would come down on them like a ton of bricks (as it did to producers of Cherries at one point). It's the difference between saying "Product X will cure Y" (illegal unless it's gone through all the testing) and "Product X may promote health" (which is entirely legal). It doesn't make much sense.
T-R 15y ago
This is presented as though it's an instance of regulatory capture - which it may be - but I don't think we really have enough information to draw that conclusion. It's entirely possible that there was concern for contamination or the like in the methods used, which would be a fair concern. On the other hand, the current manufacturing methods don't strike me as sufficient reasoning to pass on the concept as a whole, if that's indeed what the final recommendation means, as the article seems to imply.
briggsbio 15y ago
It's difficult to assess the situation without having the WHO report or an inspection. The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace. There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so. If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors). The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.
lhnn 15y ago
My thoughts exactly. All the objections seem to sidestep the revolution that this drug could be. If the science is there, but some more studies are needed, why didn't the WHO back better lab conditions and make a go for it? Either they thought it was not a viable theory for a drug, or they were avoiding it for profit/political reasons.

zemaj 15y ago

This process may be a preferable alternative to condoms, but it does not stop the spread of STDs. From the WHOs perspective there's no obvious benefit. I suspect this may be the real cause of their lack of interest.

pyre 15y ago

> Do these "modern pharmaceutical manufacturing standards" actually buy us > extra safety? They certainly buy us jobs for bureaucrats. Recently the FDA confiscated all of the birthing pools (related to the surge in popularity of water births). Apparently inflatable pools should be classified as 'medical devices.' To quote the FDA, "pregnacy is an illness and birth is a medical procedure."

towelrod 15y ago
Do you have a source for that quote?
- pyre 15y ago
  * http://blog.cuntastic.org/2011/05/26/birth-pools-seized-by-fda-in-portland-or/ http://blog.cuntastic.org/2011/05/26/birth-pools-seized-by-f... * http://blog.cuntastic.org/2011/05/27/interview-with-barbara-harper/ http://blog.cuntastic.org/2011/05/27/interview-with-barbara-...

jacoblyles 15y ago

Regulation costs account for 90% of bringing a drug to market, on average $1 billion and 10 years of clinical trials for each new drug [1]. Of course, a mere 10 years of clinical trial cannot catch all long-term side effects, and we would be safer if the FDA was more stringent. The flip side is that we would have fewer and more expensive health care options. For better or worse, our regulatory structure is heavily biased towards fewer deaths from approved treatments, very long clinical trials, and expensive health care. In general, the word "agile" and the health industry have nothing to do with each other. [1] yeah, yeah, citation needed. I pick facts up by listening to The Economist podcast on the way home, you go find a hyperlink.

pavel_lishin 15y ago

I'm sure it's not as black and white as that. There's a certain level of safety requirements, and we could probably relax them with only a small percentage of people suffering or dying as a result. We could also raise them, and decrease that number. Etc, etc., it's all a numbers game, and I'm already boring myself with this argument.

Sukotto 15y ago

Do these "modern pharmaceutical manufacturing standards" actually buy us extra safety? Yes, but we pay a price: * Evaluations take a really long time. So it's hard to get the drugs into the hands of people. * Development is now extremely expensive. That forces just about everyone except the largest drug mega-corporations out of the market. * Drugs that would be a net benefit to the world sometimes never make it through the entire process because the ROI isn't good enough, or the associated side effects are deemed too harsh. (We would likely not have aspirin today if it hadn't been developed prior to the modern way of drug development... it has too many high-risk side effects) -- On the plus side: * The drugs you do get are generally far safer and better understood than they otherwise would be * You can feel safe that each batch of the drug was made the same way, using the same process, and ends up having the same strength/effectiveness as every other batch of the same drug... even when made by a different company. (We take that for granted now... but it's actually a really big deal if you look at medication from a historical perspective.) * We have far fewer snake-oil salesmen ripping people off for cures that are, at best, useless and at worst, cause the condition to get worse, or cause birth defects, or some other harm. If we do find the drug doing harm, it gets pulled off the market

jonprins 15y ago
"We also have far fewer snake-oil salesmen ripping people off for cures" Yet we still have chiropractors and homeopathy.
- cwp 15y ago
  Two weeks ago I went to see a chiropractor. I was in so much pain I could barely walk, and my lower back wouldn't flex enough for me to stand up straight. She thought I probably had a pulled muscle. She stretched my legs and hips, twisted my spine a bit and showed me some stretches that I could do at home. I left feeling a bit sore, but otherwise fine. It took 20 minutes and cost me $60. It might not be medicine, but it's not snake-oil either.
- sorbus 15y ago
  Sadly, they get around all the regulation by not making specific medical claims. If they did, then regulation would come down on them like a ton of bricks (as it did to producers of Cherries at one point). It's the difference between saying "Product X will cure Y" (illegal unless it's gone through all the testing) and "Product X may promote health" (which is entirely legal). It doesn't make much sense.

T-R 15y ago

This is presented as though it's an instance of regulatory capture - which it may be - but I don't think we really have enough information to draw that conclusion. It's entirely possible that there was concern for contamination or the like in the methods used, which would be a fair concern. On the other hand, the current manufacturing methods don't strike me as sufficient reasoning to pass on the concept as a whole, if that's indeed what the final recommendation means, as the article seems to imply.

briggsbio 15y ago

It's difficult to assess the situation without having the WHO report or an inspection. The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace. There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so. If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors). The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.

lhnn 15y ago

My thoughts exactly. All the objections seem to sidestep the revolution that this drug could be. If the science is there, but some more studies are needed, why didn't the WHO back better lab conditions and make a go for it? Either they thought it was not a viable theory for a drug, or they were avoiding it for profit/political reasons.