Santorum

[john9blue]

asking for sources = dodging the question, amirite?

[Aradhus]

Well done you found one of the critics of the NHS, yes it isn't perfect I said that but how about you come up with your own arguments or thoughts rather than taking, at face value, the comments of a Southeast-England christian conservative who basically wants to americanise our entire political system?

The fact of the matter is we spend a lot less money on healthcare than the US, we cover people equally and fairly and the health care in the UK is not significantly worse than any other developed country.

When was the last time useful drugs were actually invented in the UK? Or any other country that has socialized medicine? Only free markets will develop new drugs and treatments, not ones that mandate costs and which drugs are allowed to be offered.

1 out of every 4 of the biggest selling drugs were developed in the Uk. 2 of the top 5 pharmaceutical companies in the world are from the uk.

Hmm... I'm going to need a link to the GlaxoSmithKline website that shows that the drugs they developed were actually developed in the UK (and not somewhere else).

I'm also going to need a link showing the relative corporate tax rates of the UK compared to the United States to discuss whether or not something other than the unbelievably awesome healthcare system corresponding to these companies being in the UK.

Finally, I'm going to need the founding date of these top 2 companies and the date that the NHS was formed.

Thanks bye.

You're just a needy little high maintenance dog, ain'tcha.

When Spain won the world cup, it was won in South africa, and not really the world, so it should be the south african cup, right?! derp-o-derp-a-derp?!

Seems like you think you already know the answers to the questions you're asking, which makes you asking me to provide links particularly tedious. I'm not a big fan of foreplay, either you whip it out or you don't, but asking me to bend closer while you slowly unzip is a little sleazy.

[tkr4lf]

Once again, you are talking out of your ass....

...FDA and their many requirements, but that is all about ensuring that the drugs that actually reach the market are safe. .

Now you're the one talking out of your ass.

So many FDA workers go to work for the companies after they push the drugs through, some consider the FDA as a simply lobby for them.
Its not that pharmaceutical companies don't do some great things, and come up with cures for horrible diseases, its more that they use the general public as guinea pigs for them, and to some degree, without their full knowledge.

My source for this statement is indirect, so can be taken with a grain of salt, but it originates from people in the FDA itself.

Well, there is a big difference in government funded research being given to pharmaceutical companies and former FDA employees going to work for pharmaceutical companies.

You may very well be correct about what you said, but it doesn't change anything I said. The FDA itself (not it's (former) employees, that is a different story) has virtually nothing to do with the process of a medication reaching the market apart from as a regulatory body. And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

Viagra was originally a heart medicine. It was during phase 1 testing that they noticed the side effect of massive erections.

I'd heard that before. Can you imagine the testee's (hehe...testee's) thoughts?

I didn't work there when the viagra testing was done, but I heard all sorts of stories. Apparently it took a while before any of the male subjects could work up the balls to even tell anybody about it. Finally some dude comes up to one of the team members and says something along the lines of "Look, nobody's really saying anything, but every guy in this study is walking around with a massive hard-on."

[thegreekdog]

Intimating that the UK is a bastion of pharmaceutical research and development is stupid. While NightStrike's arguments are similarly stupid (that NHS somehow cripples innovation is dumb), there is no reason to pretend that Glaxo or AstraZeneca are these awesome UK companies that develop awesome drugs due to the awesomeness of the UK healthcare system.

Glaxo and AZ are really American companies. They develop drugs in the US. They manufacture drugs probably somewhere in the third world. Their successes have little or nothing to do with the NHS.

[Woodruff]

And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

[aad0906]

When Spain won the world cup, it was won in South africa, and not really the world, so it should be the south african cup, right?! derp-o-derp-a-derp?!

It's the world cup allright, but since Spain won it in South Africa, we should credit South Africa for it, not Spain.

Any Americans here that have experience with both the UK and the US system of healthcare? No? Well, I have had experience with both. And the UK in my view wins (in terms of affordability at least because what good does it do to have the best doctors around but not being able to afford them).

[pmchugh]

Maybe I am getting too tired, but what has any of this got to do with anything?

I still don't see any valid refutes to a public health care system.

[aad0906]

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

Those lawsuits are part of the problem, they make US healthcare so expensive. US medical practicioners have to pay high insurance fees plus sometimes often order more tests then necessary out of fear for overlooking something or as having extra defense when sued.

[Aradhus]

Intimating that the UK is a bastion of pharmaceutical research and development is stupid. While NightStrike's arguments are similarly stupid (that NHS somehow cripples innovation is dumb), there is no reason to pretend that Glaxo or AstraZeneca are these awesome UK companies that develop awesome drugs due to the awesomeness of the UK healthcare system.

Glaxo and AZ are really American companies. They develop drugs in the US. They manufacture drugs probably somewhere in the third world. Their successes have little or nothing to do with the NHS.

I wasn't saying they manufacture awesome drugs because of the awesome healthcare system. In fact I didn't say anything on the matter. My post only implied(not very well apparently) that the type of healthcare isn't an impediment.

Is glaxo and AZ really American companies like Britain, and all of Europe, is really protected and controlled by America?

[Symmetry]

1 out of every 4 of the biggest selling drugs were developed in the Uk. 2 of the top 5 pharmaceutical companies in the world are from the uk.

Hmm... I'm going to need a link to the GlaxoSmithKline website that shows that the drugs they developed were actually developed in the UK (and not somewhere else).

I'm also going to need a link showing the relative corporate tax rates of the UK compared to the United States to discuss whether or not something other than the unbelievably awesome healthcare system corresponding to these companies being in the UK.

Finally, I'm going to need the founding date of these top 2 companies and the date that the NHS was formed.

Thanks bye.

Of course you will. And when provided those sources will be dismissed as either proving your point or totally biased. Maybe google a little bit and find the relevant information you require. Seriously, when I asked you about your info on the Warren Buffet thread I just asked for your points. And that was considered borderline unreasonable by you.

You probably wouldn't understand the sources anyway, as you're from the US (I'm assuming that you're ok with me saying that- it's not something I would say to anyone else, but it's a symmetrical reply).

First, I didn't ask you. You don't have to provide shit.

Second, I already know the answers. I was making a point (as I suspect you know given your angry and upset reaction to my post).

Third, you dismissed my Warren Buffett discussion out of hand because you don't agree with it, not because you didn't understand it (unless you're an abject moron, and your grasp of the English language leads me to believe you're not). You didn't ask about it, you decided I was wrong. And you didn't come back after I explained for the fourth time. That's sad.

Fourth, if you provide me with those sources, they will in fact prove my point. So?

First: You posted in a public forum, if you only wanted Aradhus to reply, perhaps you chose the wrong venue. There is a PM system in place, and you can tell us of your many victories in personal combat with the socialists in another thread. Sadly for all involved, you got me.

Second: And yet you posted no sources. Or indeed a point for those sources to back up. (Apologies for this one, I realise that one of your standard replies is "I already explained this "x" number of times)

Third: In this case "x" equals "4" apparently. It tends to vary, you know, your indignation at how many times you have to express yourself clearly. Should I come back to the thread? Or should I take a vow not to reply to you? Kind of sounds more virtuous than foeing, right? Plus you get to talk about your vow when other players (generic; lower case) destroy your points on the first page. It seems to be about something else now, but I guess I'm good for a few posts if that won't warrant a vow.

Fourth: This one sounds like John9Blue's work. I'm going to need to see written permission from him, or proof that you're not plagiarising before I engage in a response.

[Woodruff]

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

Those lawsuits are part of the problem, they make US healthcare so expensive. US medical practicioners have to pay high insurance fees plus sometimes often order more tests then necessary out of fear for overlooking something or as having extra defense when sued.

How does any of that refute my point regarding the FDA?

[tkr4lf]

And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

I can speak to the rigorousness of the studies.

After a single person, "First in Human" study is done, Phase 1 studies begin. Phase 1 studies are studies run with "normal", healthy individuals. The primary concern of these studies is to figure out the side effects, the proper dosage, and to ensure safety. Depending on the drug and the format of the study, there can be anywhere from 5 to 60 subjects in a single study. And they don't just run one study, they normally run numerous Phase 1 studies. And they usually do some of them at different facilities in different parts of the country. These are the studies where participants are rewarded handsomely. Usually anywhere from $2,000 to $10,000 for successfully completing the study. It all depends on the length of the study and how many procedures (blood draws, EKG's, checking of vital signs, giving urine, etc.) they have. I've seen many, many smaller studies where the subjects get about $2,500 - $4,000. The largest study I personally ever saw was a 50-something-day long study (and yeah, they have to remain inside the clinic for the full 50 days, no leaving at all...) where the participants all received $10,000. It's pretty crazy, there are people who are "professional lab rats", they do this for a living. Check out this website: http://www.jalr.org. This is set up and run by one of our regulars. These Phase 1 studies are done all over the country and these people travel all over the place to get into a study...it's nuts.

After Phase 1 studies have concluded, they start Phase 2 studies. Phase 2 studies are done on people who actually need the medication. So, if it was an AIDS drug, then only people who actually have AIDS can participate in these studies. The main goal of these is to ensure the effectiveness of the drug in people who actually suffer from the illness. (Sorry, my knowledge of the later phases of clinical trials is sorely lacking. I know way more about Phase 1, but that makes sense, considering that's where I worked.)

Then come Phase 3 studies. Rather than talk out of my ass and act like I know anything about these, I'll just say that I honestly don't know what they do in Phase 3, or Phase 4 for that matter.

All of these Phases are done after all of the initial R&D and animal studies, etc., are done.

So, this should show that the actual studies are performed rigorously. Do mistakes get made? Oh yeah, all the time. The people doing the research are still people, prone to mistakes like all people. And really, no matter how many people you test a drug on, you will never see every possible side effect that could result. There are just too many people, and each person is different.

So, I guess, my main point here is that all these lawsuits and the like, are the exception, not the rule. For every drug you hear about that causes some life threatening illness or has horrible side effects that were previously unknown, or for every lawsuit about said drugs, there are easily hundreds that reach the market and are generally safe and effective.

[Woodruff]

And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

I can speak to the rigorousness of the studies.

After a single person, "First in Human" study is done, Phase 1 studies begin. Phase 1 studies are studies run with "normal", healthy individuals. The primary concern of these studies is to figure out the side effects, the proper dosage, and to ensure safety. Depending on the drug and the format of the study, there can be anywhere from 5 to 60 subjects in a single study. And they don't just run one study, they normally run numerous Phase 1 studies. And they usually do some of them at different facilities in different parts of the country. These are the studies where participants are rewarded handsomely. Usually anywhere from $2,000 to $10,000 for successfully completing the study. It all depends on the length of the study and how many procedures (blood draws, EKG's, checking of vital signs, giving urine, etc.) they have. I've seen many, many smaller studies where the subjects get about $2,500 - $4,000. The largest study I personally ever saw was a 50-something-day long study (and yeah, they have to remain inside the clinic for the full 50 days, no leaving at all...) where the participants all received $10,000. It's pretty crazy, there are people who are "professional lab rats", they do this for a living. Check out this website: http://www.jalr.org. This is set up and run by one of our regulars. These Phase 1 studies are done all over the country and these people travel all over the place to get into a study...it's nuts.

After Phase 1 studies have concluded, they start Phase 2 studies. Phase 2 studies are done on people who actually need the medication. So, if it was an AIDS drug, then only people who actually have AIDS can participate in these studies. The main goal of these is to ensure the effectiveness of the drug in people who actually suffer from the illness. (Sorry, my knowledge of the later phases of clinical trials is sorely lacking. I know way more about Phase 1, but that makes sense, considering that's where I worked.)

Then come Phase 3 studies. Rather than talk out of my ass and act like I know anything about these, I'll just say that I honestly don't know what they do in Phase 3, or Phase 4 for that matter.

All of these Phases are done after all of the initial R&D and animal studies, etc., are done.

So, this should show that the actual studies are performed rigorously. Do mistakes get made? Oh yeah, all the time. The people doing the research are still people, prone to mistakes like all people. And really, no matter how many people you test a drug on, you will never see every possible side effect that could result. There are just too many people, and each person is different.

So, I guess, my main point here is that all these lawsuits and the like, are the exception, not the rule. For every drug you hear about that causes some life threatening illness or has horrible side effects that were previously unknown, or for every lawsuit about said drugs, there are easily hundreds that reach the market and are generally safe and effective.

Ok, I understand all of that. But that just doesn't strike me as particularly rigorous, given the potential problems (particularly long-term) that can occur from medication. I guess to my view, "rigorous" would almost have to include some sort of a long-term study (which admittedly could be in the Phase 3 or 4 you described, as I have far less knowledge of it than you do).

[tkr4lf]

And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

I can speak to the rigorousness of the studies.

After a single person, "First in Human" study is done, Phase 1 studies begin. Phase 1 studies are studies run with "normal", healthy individuals. The primary concern of these studies is to figure out the side effects, the proper dosage, and to ensure safety. Depending on the drug and the format of the study, there can be anywhere from 5 to 60 subjects in a single study. And they don't just run one study, they normally run numerous Phase 1 studies. And they usually do some of them at different facilities in different parts of the country. These are the studies where participants are rewarded handsomely. Usually anywhere from $2,000 to $10,000 for successfully completing the study. It all depends on the length of the study and how many procedures (blood draws, EKG's, checking of vital signs, giving urine, etc.) they have. I've seen many, many smaller studies where the subjects get about $2,500 - $4,000. The largest study I personally ever saw was a 50-something-day long study (and yeah, they have to remain inside the clinic for the full 50 days, no leaving at all...) where the participants all received $10,000. It's pretty crazy, there are people who are "professional lab rats", they do this for a living. Check out this website: http://www.jalr.org. This is set up and run by one of our regulars. These Phase 1 studies are done all over the country and these people travel all over the place to get into a study...it's nuts.

After Phase 1 studies have concluded, they start Phase 2 studies. Phase 2 studies are done on people who actually need the medication. So, if it was an AIDS drug, then only people who actually have AIDS can participate in these studies. The main goal of these is to ensure the effectiveness of the drug in people who actually suffer from the illness. (Sorry, my knowledge of the later phases of clinical trials is sorely lacking. I know way more about Phase 1, but that makes sense, considering that's where I worked.)

Then come Phase 3 studies. Rather than talk out of my ass and act like I know anything about these, I'll just say that I honestly don't know what they do in Phase 3, or Phase 4 for that matter.

All of these Phases are done after all of the initial R&D and animal studies, etc., are done.

So, this should show that the actual studies are performed rigorously. Do mistakes get made? Oh yeah, all the time. The people doing the research are still people, prone to mistakes like all people. And really, no matter how many people you test a drug on, you will never see every possible side effect that could result. There are just too many people, and each person is different.

So, I guess, my main point here is that all these lawsuits and the like, are the exception, not the rule. For every drug you hear about that causes some life threatening illness or has horrible side effects that were previously unknown, or for every lawsuit about said drugs, there are easily hundreds that reach the market and are generally safe and effective.

Ok, I understand all of that. But that just doesn't strike me as particularly rigorous, given the potential problems (particularly long-term) that can occur from medication. I guess to my view, "rigorous" would almost have to include some sort of a long-term study (which admittedly could be in the Phase 3 or 4 you described, as I have far less knowledge of it than you do).

It could be, but I doubt it. From my understanding, there aren't many (if any at all) "long term" studies like what would be ideal. The costs associated with running these studies is already enormous. I couldn't imagine how much they would have to spend to run the type of study that would pass your rigorous test.

That's not to say I don't agree. I do. I think they should continue to run tests on these medications, just to ensure the safety and efficacy. Unfortunately, big pharma is just like any other "evil corporation" in that their bottom line is profits. I think that in their eyes, it's more cost effective to simply pay off the people who bring up the law suits than to devote the significant amount of money and man hours needed to do a serious long-term study. That's pretty fucked up, but it is the truth (or at least I think it is, I could be wrong).

[BigBallinStalin]

You may very well be correct about what you said, but it doesn't change anything I said. The FDA itself (not it's (former) employees, that is a different story) has virtually nothing to do with the process of a medication reaching the market apart from as a regulatory body. And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

But there are other alternatives other than FDA or no certification agencies at all. Why can't there be other certification organizations which bear their reputation on the risk of being wrong?

The FDA can label something "FDA-approved" through an inefficient filtering process, and sometimes they get it wrong. But do they go out of business after killing many people? Nope! I find that worrisome, and I don't see why allowing competition into the market of certification for drugs is being prohibited*...


*I'm not implying anything about your stance. I'm just wondering what you think about allowing certification agencies being allowd to compete against FDA's monopoly.

[tkr4lf]

You may very well be correct about what you said, but it doesn't change anything I said. The FDA itself (not it's (former) employees, that is a different story) has virtually nothing to do with the process of a medication reaching the market apart from as a regulatory body. And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

But there are other alternatives other than FDA or no certification agencies at all. Why can't there be other certification organizations which bear their reputation on the risk of being wrong?

The FDA can label something "FDA-approved" through an inefficient filtering process, and sometimes they get it wrong. But do they go out of business after killing many people? Nope! I find that worrisome, and I don't see why allowing competition into the market of certification for drugs is being prohibited*...


*I'm not implying anything about your stance. I'm just wondering what you think about allowing certification agencies being allowd to compete against FDA's monopoly.

Oh, I wouldn't have a problem with competition. It could only result in improvement. I don't agree with the government's monopoly over certain things, food and drug safety being one of them.

I too find it worrisome that there is basically nobody watching the watchers, ensuring they are doing their job properly. I just wanted to point out that without them, things would be much worse than they already are. However, that doesn't mean there isn't room to improve. And I think allowing competition would improve things, as that's what tends to happen when there is competition for providing a service.

Admittedly, I know very little about economics, free markets, and the like, so I wouldn't have a clue about how it could get started, how it ( a private, for-profit company that provided the same services as the FDA) would run, or how effective it would be. But I do agree that it couldn't hurt to try. I'm pretty sure the FDA wouldn't like that, though. And good luck getting an embedded government organization to give up its power...

[Aradhus]

Private companies competing to regulate drugs. Oh yeah, no worries there..

[BigBallinStalin]

Private companies competing to regulate drugs. Oh yeah, no worries there..

Sure, there's plenty of worries. The lawsuits would sort out the losers from the winners, thus developing a trusty reputation behind Drug Certification Agency A's approval stamp.

Of course, I wouldn't be the first to take their drugs. I'd wait it out some years until then, or if I really needed a certain medicine, and I couldn't get in the clinical studies controlled by the FDA, then there's my opportunity to live: thank you, Drug Certification Agency A.

Competition would provide more opportunities and a faster rate of innovation in the long-run. This would very likely drive down the costs of producing and distributing safe drugs. A monopoly like the FDA has very little incentive to become more efficient and just as safe.




EDIT: @TKR, thanks for responding!

[Woodruff]

I think that in their eyes, it's more cost effective to simply pay off the people who bring up the law suits than to devote the significant amount of money and man hours needed to do a serious long-term study.

And they're probably right. Particularly when the long-term study might even result in the product not selling at all...REALLY not worth the risk.

[thegreekdog]

Intimating that the UK is a bastion of pharmaceutical research and development is stupid. While NightStrike's arguments are similarly stupid (that NHS somehow cripples innovation is dumb), there is no reason to pretend that Glaxo or AstraZeneca are these awesome UK companies that develop awesome drugs due to the awesomeness of the UK healthcare system.

Glaxo and AZ are really American companies. They develop drugs in the US. They manufacture drugs probably somewhere in the third world. Their successes have little or nothing to do with the NHS.

I wasn't saying they manufacture awesome drugs because of the awesome healthcare system. In fact I didn't say anything on the matter. My post only implied(not very well apparently) that the type of healthcare isn't an impediment.

Is glaxo and AZ really American companies like Britain, and all of Europe, is really protected and controlled by America?

First, I did probably overreact a little, but your post annoyed me.

If you look up the two companies, you will note the number of employees, expenses, property, plant, and equipment that is in the United States compared to what is in the UK. I'm not saying that Europe or the UK is protected by America. I was pointing out in my overly sarcastic post that there is likely very little connection between the NHS and pharmaceutical development by two UK companies. In fact, I would say I'm arguing against both you and Nightstrike. The pharmaceutical industry in the UK is neither hurt nor helped by the NHS. Your post indicated, to me (and again, I probably overreacted) that you thought the NHS helped pharmaceutical development.

First: You posted in a public forum, if you only wanted Aradhus to reply, perhaps you chose the wrong venue. There is a PM system in place, and you can tell us of your many victories in personal combat with the socialists in another thread. Sadly for all involved, you got me.

Second: And yet you posted no sources. Or indeed a point for those sources to back up. (Apologies for this one, I realise that one of your standard replies is "I already explained this "x" number of times)

Third: In this case "x" equals "4" apparently. It tends to vary, you know, your indignation at how many times you have to express yourself clearly. Should I come back to the thread? Or should I take a vow not to reply to you? Kind of sounds more virtuous than foeing, right? Plus you get to talk about your vow when other players (generic; lower case) destroy your points on the first page. It seems to be about something else now, but I guess I'm good for a few posts if that won't warrant a vow.

Fourth: This one sounds like John9Blue's work. I'm going to need to see written permission from him, or proof that you're not plagiarising before I engage in a response.

Aw, Symm - I didn't mean to offend you buddy. If you don't have the wherewithal to address my points, it's okay. Resorting to ad hominem attacks is fine big guy. As Saxi may say - we're all friends here. Let's talk it out.

[PLAYER57832]

And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

I can speak to the rigorousness of the studies.

After a single person, "First in Human" study is done, Phase 1 studies begin. Phase 1 studies are studies run with "normal", healthy individuals. The primary concern of these studies is to figure out the side effects, the proper dosage, and to ensure safety. Depending on the drug and the format of the study, there can be anywhere from 5 to 60 subjects in a single study. And they don't just run one study, they normally run numerous Phase 1 studies. And they usually do some of them at different facilities in different parts of the country. These are the studies where participants are rewarded handsomely. Usually anywhere from $2,000 to $10,000 for successfully completing the study. It all depends on the length of the study and how many procedures (blood draws, EKG's, checking of vital signs, giving urine, etc.) they have. I've seen many, many smaller studies where the subjects get about $2,500 - $4,000. The largest study I personally ever saw was a 50-something-day long study (and yeah, they have to remain inside the clinic for the full 50 days, no leaving at all...) where the participants all received $10,000. It's pretty crazy, there are people who are "professional lab rats", they do this for a living. Check out this website: http://www.jalr.org. This is set up and run by one of our regulars. These Phase 1 studies are done all over the country and these people travel all over the place to get into a study...it's nuts.

After Phase 1 studies have concluded, they start Phase 2 studies. Phase 2 studies are done on people who actually need the medication. So, if it was an AIDS drug, then only people who actually have AIDS can participate in these studies. The main goal of these is to ensure the effectiveness of the drug in people who actually suffer from the illness. (Sorry, my knowledge of the later phases of clinical trials is sorely lacking. I know way more about Phase 1, but that makes sense, considering that's where I worked.)

Then come Phase 3 studies. Rather than talk out of my ass and act like I know anything about these, I'll just say that I honestly don't know what they do in Phase 3, or Phase 4 for that matter.

All of these Phases are done after all of the initial R&D and animal studies, etc., are done.

So, this should show that the actual studies are performed rigorously. Do mistakes get made? Oh yeah, all the time. The people doing the research are still people, prone to mistakes like all people. And really, no matter how many people you test a drug on, you will never see every possible side effect that could result. There are just too many people, and each person is different.

So, I guess, my main point here is that all these lawsuits and the like, are the exception, not the rule. For every drug you hear about that causes some life threatening illness or has horrible side effects that were previously unknown, or for every lawsuit about said drugs, there are easily hundreds that reach the market and are generally safe and effective.

Ok, I understand all of that. But that just doesn't strike me as particularly rigorous, given the potential problems (particularly long-term) that can occur from medication. I guess to my view, "rigorous" would almost have to include some sort of a long-term study (which admittedly could be in the Phase 3 or 4 you described, as I have far less knowledge of it than you do).

It could be, but I doubt it. From my understanding, there aren't many (if any at all) "long term" studies like what would be ideal. The costs associated with running these studies is already enormous. I couldn't imagine how much they would have to spend to run the type of study that would pass your rigorous test.

That's not to say I don't agree. I do. I think they should continue to run tests on these medications, just to ensure the safety and efficacy. Unfortunately, big pharma is just like any other "evil corporation" in that their bottom line is profits. I think that in their eyes, it's more cost effective to simply pay off the people who bring up the law suits than to devote the significant amount of money and man hours needed to do a serious long-term study. That's pretty fucked up, but it is the truth (or at least I think it is, I could be wrong).

Even the most rigorous study is incomplete, but
right now, there is not even any real obligation to report probelms once a drug is released, not in a sustained and equal manner.

At some point, you have to cut off any study. The truth is that you don't really know a drug's full impact unless it is used for a lifetime among huge numbers of people. However, most people are willing to accept that. The problem comes when people are not given full information about what IS available and when there are incentives to distort real results.

This comes in many guises. You have a lot of people claiming that the "FDA is a joke", you have people claiming that vaccines should not be used because there is a 1 in 10,000 or 1 in 1000 chance of a serious side effect (but ignoring the risk from getting the diseases themselves).

In the end, this is less about efficacy of testing and more about education.

[PLAYER57832]

You may very well be correct about what you said, but it doesn't change anything I said. The FDA itself (not it's (former) employees, that is a different story) has virtually nothing to do with the process of a medication reaching the market apart from as a regulatory body. And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

But there are other alternatives other than FDA or no certification agencies at all. Why can't there be other certification organizations which bear their reputation on the risk of being wrong?

UH.. you have described the FDA. However, any process will be corrupted when there are huge amounts on money involved. More telling than that there have been issues is that these issues have been discovered because of the freedom of information act, various investigations by folks concerned with everything from fiscal responsibility to testing regimes to ... you name it.

The FDA can label something "FDA-approved" through an inefficient filtering process, and sometimes they get it wrong. But do they go out of business after killing many people? Nope! I find that worrisome, and I don't see why allowing competition into the market of certification for drugs is being prohibited*...

That last is because of patents. The theory is that if they did not have that incentive, they would not be marketing their drugs. However, the problem is that companies don't really and truly do the bulk of the research (in many cases). ALSO, many just hold onto patents without necessarily even producing them. Sometimes the reasons are "legitimate" from a medical perspective, but many times a drug is not produced simply becuase a company cannot make as much profit as they can for another. That is perfectly acceptable if you are talking about tennis shoes or toasters. However, when you are talking about medications, particularly medications that save people's lives, then its just not OK.

If you allowed the "free market" to dictate drugs, you would see what we now have with appliances. You can no longer get a refridgerator or any major appliance that lasts more than 5 years. Even finding parts for many items is difficult, no matter how easy they are to repair. We just wound up having to pitch a 3 year old dishwasher simply because the company was no longer making the front panel! Its bad enough when its a dishawasher. Its tragic when that happens with medications.

[PLAYER57832]

Well done you found one of the critics of the NHS, yes it isn't perfect I said that but how about you come up with your own arguments or thoughts rather than taking, at face value, the comments of a Southeast-England christian conservative who basically wants to americanise our entire political system?

The fact of the matter is we spend a lot less money on healthcare than the US, we cover people equally and fairly and the health care in the UK is not significantly worse than any other developed country.

When was the last time useful drugs were actually invented in the UK? Or any other country that has socialized medicine? Only free markets will develop new drugs and treatments, not ones that mandate costs and which drugs are allowed to be offered.

OUR system is not a free market system. Companies take government funded research and "tweek" it or work on things that will provide quick pay offs.

Viagra.. not cures for breast cancer, never mind malaria.

There are 2 primary reasons the US has provided so many drugs to date. The first is our sheer size. Our institutions have attracted people from all over. Other places had good research, but we tended to have more.

AND.. our wonderful education system, particularly the higher education system that has been open to more people than other countries' systems.

NOTHING about free markets. Sorry, that is pure illusion. (and no, you CANNOT find this by checking patents because the government does not get patents)

Once again, you are talking out of your ass. Viagra was originally a heart medicine. It was during phase 1 testing that they noticed the side effect of massive erections. Fun fact: The PPD phase 1 clinic here in Austin that I worked at actually tested Viagra.

And you think that runs counter to what I said?
Many drugs are discovered that way, but its only when they have a highly marketable effect that the companies push for approval.

ALSO... the drug companies did NOT come up with a cure for malaria, and most of that heart research to which you refer is funding by government grants. Some individual studies in the mix are not, but on the whole.. we get drugs more from government research than private funding. AND, when it IS "private" funding, its often groups the the Komen foundation, American Diabetes association, etc. NOT private corporations needing a profit.

Also, these companies don't take government funded research and "tweek" it. They have extensive R&D departments of their own that do the research, and then Contract Research Organizations to do the actual studies. The only part the government plays in any of this is the FDA and their many requirements, but that is all about ensuring that the drugs that actually reach the market are safe.

LOL..
Not wrong here. Just look at the funding for any university doing medical studies, as well as even the funding for many of those "private" companies. Its not really so private. Also, again, they do "big bang" research. They don't do baseline research that takes years, may or may not have a real result..b ut that lays the foundation for all thes "phenomenal discoveries".

You really should try to learn about things before you just start spouting stuff out about things of which you have no knowledge.

Then again, you should take your own advice.

I, others have posted this research many times, in the Socialized medicine thread and other places. We KEEP posting it.. and you promptly ignore it.

[PLAYER57832]

And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

I have difficulty understanding how rigorous the clinical testing is when we have numerous class action lawsuits going on for these medications causing extremely serious problems for a large number of people.

I can speak to the rigorousness of the studies.

After a single person, "First in Human" study is done, Phase 1 studies begin. Phase 1 studies are studies run with "normal", healthy individuals. The primary concern of these studies is to figure out the side effects, the proper dosage, and to ensure safety. Depending on the drug and the format of the study, there can be anywhere from 5 to 60 subjects in a single study. And they don't just run one study, they normally run numerous Phase 1 studies. And they usually do some of them at different facilities in different parts of the country. These are the studies where participants are rewarded handsomely. Usually anywhere from $2,000 to $10,000 for successfully completing the study. It all depends on the length of the study and how many procedures (blood draws, EKG's, checking of vital signs, giving urine, etc.) they have. I've seen many, many smaller studies where the subjects get about $2,500 - $4,000. The largest study I personally ever saw was a 50-something-day long study (and yeah, they have to remain inside the clinic for the full 50 days, no leaving at all...) where the participants all received $10,000. It's pretty crazy, there are people who are "professional lab rats", they do this for a living. Check out this website: http://www.jalr.org. This is set up and run by one of our regulars. These Phase 1 studies are done all over the country and these people travel all over the place to get into a study...it's nuts.

After Phase 1 studies have concluded, they start Phase 2 studies. Phase 2 studies are done on people who actually need the medication. So, if it was an AIDS drug, then only people who actually have AIDS can participate in these studies. The main goal of these is to ensure the effectiveness of the drug in people who actually suffer from the illness. (Sorry, my knowledge of the later phases of clinical trials is sorely lacking. I know way more about Phase 1, but that makes sense, considering that's where I worked.)

Then come Phase 3 studies. Rather than talk out of my ass and act like I know anything about these, I'll just say that I honestly don't know what they do in Phase 3, or Phase 4 for that matter.

All of these Phases are done after all of the initial R&D and animal studies, etc., are done.

So, this should show that the actual studies are performed rigorously. Do mistakes get made? Oh yeah, all the time. The people doing the research are still people, prone to mistakes like all people. And really, no matter how many people you test a drug on, you will never see every possible side effect that could result. There are just too many people, and each person is different.

So, I guess, my main point here is that all these lawsuits and the like, are the exception, not the rule. For every drug you hear about that causes some life threatening illness or has horrible side effects that were previously unknown, or for every lawsuit about said drugs, there are easily hundreds that reach the market and are generally safe and effective.

A RIGOROUS study into drug impacts lasts years, not days. Sorry.. you just prove Woodruff's point.

[BigBallinStalin]

You may very well be correct about what you said, but it doesn't change anything I said. The FDA itself (not it's (former) employees, that is a different story) has virtually nothing to do with the process of a medication reaching the market apart from as a regulatory body. And people can say what they like about the FDA (and I won't defend them, I'm not a huge fan either), but without them, we wouldn't have side effects listed on the sides of bottles, we wouldn't have rigorous clinical testing being done on all new medications, etc.

But there are other alternatives other than FDA or no certification agencies at all. Why can't there be other certification organizations which bear their reputation on the risk of being wrong?

UH.. you have described the FDA. However, any process will be corrupted when there are huge amounts on money involved. More telling than that there have been issues is that these issues have been discovered because of the freedom of information act, various investigations by folks concerned with everything from fiscal responsibility to testing regimes to ... you name it.

The FDA can label something "FDA-approved" through an inefficient filtering process, and sometimes they get it wrong. But do they go out of business after killing many people? Nope! I find that worrisome, and I don't see why allowing competition into the market of certification for drugs is being prohibited*...

That last is because of patents. The theory is that if they did not have that incentive, they would not be marketing their drugs. However, the problem is that companies don't really and truly do the bulk of the research (in many cases). ALSO, many just hold onto patents without necessarily even producing them. Sometimes the reasons are "legitimate" from a medical perspective, but many times a drug is not produced simply becuase a company cannot make as much profit as they can for another. That is perfectly acceptable if you are talking about tennis shoes or toasters. However, when you are talking about medications, particularly medications that save people's lives, then its just not OK.

If you allowed the "free market" to dictate drugs, you would see what we now have with appliances. You can no longer get a refridgerator or any major appliance that lasts more than 5 years. Even finding parts for many items is difficult, no matter how easy they are to repair. We just wound up having to pitch a 3 year old dishwasher simply because the company was no longer making the front panel! Its bad enough when its a dishawasher. Its tragic when that happens with medications.

What appliances have you been buying? Mine are awesome!