Oh boy, it’s time again to try to disabuse people of the notion that the NIH and academic labs are really behind all new drugs. Here is Derek Lowe’s list of postings on the topic. To try to summarize:
A target is not a treatment. In other words, just because it appears that hitting receptor A has an effect on B doesn’t mean it will actually work in animals or humans.
A hit is not a drug. A hit may not even be a lead. Any number of molecules can give a response in an assay. It doesn’t mean that they will all work for any number of reasons.
Lots of analogs of the lead need to be synthesized. You always want to have something else to try in case your first lead goes down. This takes people and money, even if the syntheses are pretty convergent. You’ll need to make a reasonable amount on small scale as well for testing.
Once you’ve finally narrowed it down to a single molecule, you still need to make more of it. Lots more. There’s lots of studies before you even get to Phase I in humans. And unless you’ve gotten extremely lucky, it’s unlikely that the original synthetic route will scale to the amounts required and even less likely that it would be fine for plant production. So now your target comes to me and chemists like me.
I get the fun of trying to turn whatever your original route was into something we can do on a large scale. Large scale may only be 100 g at one point in time that can be made in my hood or a larger amount in our kilo lab. Or it could be making sure we have a route that can go into small-scale GMP and eventually the plant. Developing a suitable process can take months or years. In the meantime, the formulations people are coming up with ways to make a single compound into a useable form, the analytical chemists are coming up with ways to make sure that we can always test that the material meets spec, we’re making sure that the chemistry can be performed safely, and the chemical engineers are making sure that the process can work in their equipment.
You’ve got your material, it’s made it all the way through pre-Phase I testing, and you’re ready to go into humans for the initial studies on blood levels and tolerability. In the meantime, you still need to be sure that you’ll have a good enough route and trusted suppliers to supply materials going forward.
Pass Phase I? Great. Now it’s time to give it to sick patients in Phase II. Will it actually do in the human body what you want it to do? If it doesn’t, be glad you failed right now and not in Phase III.
Pass Phase II? Great. Here’s the last set of studies with Phase III before the FDA and other agencies will let you sell it. Better pray you don’t fail now. Phase III trials are huge and hugely expensive. A failure in Phase III represents most of a decade of work going down.
Congratulations, you have a drug. It’s taken probably a decade of work, lots of people, gobs of money, and you’ve beaten the odds. Better hope it makes enough cash to recoup all the costs and doesn’t wind up being pulled off the market for reasons that were not seen in Phase III but were observed over time in the general population (say, for instance, the COX2 inhibitors.)
[QUOTE=FiveYearLurker]
Because there is a big difference between saying, “Hey, I’m a layperson and I don’t understand why cancer hasn’t been cured,” vs. “Hey, I’m a layperson and I don’t understand why cancer hasn’t been cured and it’s probably because you greedy people who have spent your lives trying to study this disease are secretly conspiring to make sure that it is never actually cured.”
[/QUOTE]
There is a big difference between asking “Is a conspiracy possible?” and stating “This is a conspiracy.”, so some of you can just pull your dick out of the high horse you’re fucking.
[QUOTE=FiveYearLurker]
I’m a scientist. Nearly everyone I know is a scientist. We are all working hard to cure these diseases. We spent our youth in the lab earning a pittance because of passion for science. This conspiracy that you are “just asking questions about” would have to involve me and everyone I know.
[/QUOTE]
Oh, please, cue the violins. Do you need a tissue? I’m pretty sure there’s a pill for calming your emotional overreactions.
There have been some excellent posts here that have helped me to clarify my understanding (or misunderstand rather) of how the industry works. I don’t think questioning any industry is necessarily a bad thing, and I appreciate those who have shared information with me in a clear way.
Oh and thanks for that little nugget, Captain Obvious.
JackMannii, when i said “I thought that the pharmaceutical companies were behind most of the research.”, I wasn’t clear. What I meant was, I had previously thought that the drug companies were behind all of the research, now I see from her post that they are not.
To be JAQing off, I would have to have more knowledge of how things work, and just trying to incite. obviously, I kicked the beehive, which I do for fun sometimes, but this time it wasn’t intentional. I clearly stated that I am a layperson.
By the way, step #8 is mostly where I’m involved in the process, and in the clinic that suggests to patients that they might or might not want to participate. As I noted before, I have seen multiple failures on this end of things, including one device failure (that looked like it had serious potential, and for a sight-destroying disease where there is still no treatment, much less a cure) that bankrupted the small company that created it.
I would still like to hear a single example of BIG PHARMA finding a cure for a disease and withholding it so they can continue to treat the symptoms. I suspect I will be waiting awhile.
I don’t know about the withholding of a cure for anything, but if Ben Goldacre’s criticisms of the pharmaceutical industry are accurate, I wouldn’t put it past them. For clarity, I will say that I am not an anti-vaxxer or a conspiracist.
Looks like I should have read further into the article I linked, although the cited case is only of withholding treatment, not suppressing a cure:
That has happened decades ago in the US, and there are serious protections against it happening here (and in most developed countries) today. The main example is via the US government: the Tuskegee syphilis study in the 1930s to 1970s where a study of the progress of untreated syphilis was allowed to continue even after a cure was developed because the researchers wanted to get more data - and frankly, because they probably didn’t really care as much about poor black men as they should have.
This lead to the creation of the Belmont Report which is one of the prime documents governing what constitutes good clinical practice in research, as well as the formation of the Office for Human Research Protections.
I am a member of my hospital’s Institutional Review Board, which oversees new and continuing studies carried out there, and evaluates them for ethics, scientific validity, etc. Studies comparing medication efficacies have to establish both to the FDA (or equivalent agencies elsewhere) and to the institutions carrying them out that they’re using the appropriate alternative treatments as a comparison.
Probably the worst I’ve personally seen is a study that was putting patients on two different pain medications for some kind of problem, then abruptly discontinuing them at the end of the study. One of them was oxycodone. We sent the study back, telling them to justify not tapering them off the dose, or add in a tapering plan. I know problems must and do sneak past oversight boards, but I would say most modern countries have decent review oversight on studies, and the regulations are being adjusted every year.
Of course any company has people and groups who are interested in pushing boundaries, evading rules, breaking laws, if it means they will profit tremendously. Sometimes the problems are just due to laziness, apathy, etc. instead of greed. When any of that happens you get problems like oil rigs exploding or factory workers being worked like slaves or poisonous additives going into baby formula and pet food or unethical research.
Ben Goldacre has written very good articles on misdeeds in the pharmaceutical industry and on alt med quackery. But I’ve yet to see him claim that Big Pharma is preventing cures from being available.
And given the quadrabillions to be made marketing a breakthrough cure for any chronic ailment or cancer, pharma companies would have to be stupid beyond belief not to take advantage and knock their competitors silly.
I read a few years back that RLS is often associated with depression. Your post confirms that I didn’t misremember. I have not been as regular about taking prozac lately. Back I go to better self-discipline.
Someone mentioned Vitamin C too. Thanks for that. That’s another daily duty that I have let slide.
Thanks for this information. I do have iron-deficient anemia and have avoided getting back to Geritol. (I can’t swallow iron pills.) Vitamin D is something else I have been skipping.
Meanwhile, the RLS has been going crazy. Thanks to all of you for your reminders.
I get so tired of taking pills. I’m sure many of you understand.
Requip/Roprinole has helped my wife immensely. She has had to fiddle with the dose to decrease it enough to avoid sleepiness and has found that she needs to take it no later than 6pm.
I missed where somebody said he did. My point was that his criticisms of the pharmaceutical industry are grave. In my mind, those criticisms raise the suspicion that if there were a way to profit by withholding a cure for some ailment, some segment(s) of the industry might do so.
I should say that I don’t see how there could be a profit using such methods. Further, I think it would be extremely dangerous for a company to knowingly do so.
I’d also like to observe that asking questions is not always JAQ. I’m aware of how annoying JAQ can be, but you and I will not be correct if our immediate response to questions on certain topics is ridicule. Further, if the person really is JAQ, that person is a conspiracist and in my understanding there is very little hope of dissuading conspiracists. Ridiculing them will not change their minds and may make the skeptic look like a bully, thereby raising sympathy for the crackpot, so it is counterproductive to do so. Of course, that’s like the advice to not feed trolls, some people get off on it. And thus we have the situation where skeptics and conspiracists JAQ each other off.
[QUOTE=Dave Hartwick]
I’m aware of how annoying JAQ can be, but you and I will not be correct if our immediate response to questions on certain topics is ridicule.
[/QUOTE]
I think some people are extremely defensive which I can understand now. I hadn’t realized how frequently many of you must come up against the idea that you are all money grubbing no morals shyters. That’s likely very frustrating and certainly sheds some light on many of the responses here.
I understand many things in relation to vaccines and the eradication of diseases that I hadn’t previously considered. I also better understand the process of how a drug is developed and tested. Thanks to those who were able effectively convey that information to me. The rest of you are just stupid assholes that like to hear yourselves talk and you should shut your dicksuckers.
Oh, upper management are the money grubbing no morals shysters. Us scientists are just trying to survive the next site closing, reorganization, and layoffs. Unfortunately, the shysters are rarely the ones who get fired.
Having lost many nights of sleep over this, I totally feel you. A magnesium supplement now helps my RLS like you wouldn’t believe. It’s a long read, but my [battle story](Having lost countless nights of sleep due to RLS, I feel your pain. A magnesium supplement has helped me tremendously. It’s a long read, but here’s how I discovered it:http://m.voices.yahoo.com/magnesium-calms-restless-leg-syndrome-1816063.html) is here if you’re interested.
