Health Care in the USA

[KEW]

First, this is not a political thread, so please try to keep it on topic as such!

The linked article on the surface is talking about doing more accurate research by using primates instead of lab rats, which is surely a positive regarding accuracy of treatments.

Animal rights advocates don't like the idea of the monkeys being confined without a good source of exercise. I say give the monkeys a recliner and cable TV - they'll figure out how to work it and their lack of exercise will be by choice like many of us!
...Or would that be inhumane (I could argue it either way)!

However, what really struck me in this article was:

Rinat Neuroscience had an experimental drug that sharply reduced appetite in rodents. But obese baboons in San Antonio doubled or tripled their food intake when they got the drug.

The surprising result prompted Pfizer, which acquired Rinat, to explore whether the drug instead could promote weight gain, perhaps for cancer patients or others suffering from wasting.

So, is drug development really this trial and error? It sounds like they have little idea of the mechanism, but are fine with flipping the drug to a completely opposite purpose!

Again - Please, let's try to avoid getting political here!

http://www.nytimes.com/2011/02/20/health/20monkey.html?_r=2

 

[Todesengel]

Good read! Thanks for posting the link.

 

[Swerd]

In cancer drugs (the subject I know) the FDA requires (by federal law) that new drugs be tested in rats and dogs, and more often recently, monkeys before any human trials are done. There have been a number of times where major differences were found when comparing responses or toxicity in monkeys to other non-primates.

So, regardless of what animal rights people say, testing in monkeys is definitely here to stay for any drug that may become licensed for sale in the US. In fact you can argue that the animal rights protests were directly responsible the huge increase in costs of all animal testing.

Yes, new drug development really does come down to trial and error. In the past 25 years science has become much better at understanding mechanisms of action for potential new drugs. But when it comes to determining the safety of these new drugs, the only way to find out is trial and error.

 

[KEW]

Yes, new drug development really does come down to trial and error. In the past 25 years science has become much better at understanding mechanisms of action for potential new drugs. But when it comes to determining the safety of these new drugs, the only way to find out is trial and error.

Yes, I definitely agree that safety requires trial and error testing, but in this case it wasn't safety issues, but the mechanism/application which was completely mistaken.

 

[Swerd]

Yes, I definitely agree that safety requires trial and error testing, but in this case it wasn't safety issues, but the mechanism/application which was completely mistaken.

That isn't the first time something was first studied in the lab with mice or rats, and much later it was found that humans (or other primates) work very differently. Pfizer just changed the title, and moved along . As long as they can find a market for their drug, and demonstrate its efficacy and safety to the FDA, they're doing it right.

 

[highfigh]

First, I say give the monkeys a recliner and cable TV - they'll figure out how to work it and their lack of exercise will be by choice like many of us!
...Or would that be inhumane (I could argue it either way)!

No, inhumane would be strapping them in that chair and making them watch some of the garbage that's popular on TV with no way to escape, close their eyes or cover their ears.

Ohhhh, I have a plan! Waterboarding terrorists? Not anymore!

 

[KEW]

TV with no way to escape, close their eyes or cover their ears.

Clockwork Orange, what a great book!

 

[skers_54]

Yes, I definitely agree that safety requires trial and error testing, but in this case it wasn't safety issues, but the mechanism/application which was completely mistaken.

Drugs are extremely complex and often unpredicable. Very small differences in structure can have large changes in efficacy. Plus, a lot of times the mechanism is paradoxical. Beta blockers, some of the most efficatious heart meds in use, for a long time were contraindicated in heart failure because they reduce the heart's ability to pump blood over a short time. However, it was found that this actually leads to an increase in heart function over a longer period of time. A newer osteoporosis drug (teriparatide) works similarly.

There are also quite a few drugs that are commonly used that we're not sure of the mechanism for. Tylenol is a great example. Very useful and overall safe, but with mechanism unknown. In the end, efficacy and safety are more important than mechanism from a clinical standpoint. Now, often one comes with the other but you don't see any labeling changes or FDA decrees when the proposed mechanism of action changes (which is more common than you would think) like you do if a med is shown to be unsafe.

 

[highfigh]

Clockwork Orange, what a great book!

"Is it safe? Is it safe?"

 

[mtrycrafts]

"Is it safe? Is it safe?"

Marathon Man.

 

[s162216]

It is like that with how drugs are developed, basically drug companies have libraries of hundreds of thousands of different types of molecules etc that they try and see whether it has an effect on the receptors of interest for a medical condition in tissue samples such as ilium or trachea initially, and then whole animals if its successful, and most of the time there is no effect in the tissue sample or in the actual whole animal it shows unwanted/no effects. Eventually if this is successful, then after a long time human trials can begin and a long time after that it can come to market if after multiple trials it has shown to be relatively safe and of clinical use.
Of course throughout this it could be that the drug actually shows no effect in the condition of interest but it may show 'side effects' that are useful in other conditions.
Why do you think it takes usually about 10 years and about $2,000,000,000 to develop a drug and bring it to market?

The biggest example is probably 'Sildenafil citrate', popularly known as Viagra, which was originally designed as a drug for angina but in humans it was actually shown to have very little effect but the other 'interesting' property was discovered and Pfizer decided to market it for that instead. to recoup their loses and in the process made them a fortune.

I'm studying for a degree in Pharmacology at university and I get to learn about all this sort of stuff all week, its very interesting and certainly gives you a different take on what drugs are and how drug companies work.