focused on human randomized controlled trials that were funded by the US National Heart, Lung, and Blood Institute (NHLBI). The authors conclude that registration of trials seemed to be the dominant driver of the drastic change in study results. They found no evidence that the trend could be explained by shifting levels of industry sponsorship or by changes in trial methodologies.
does anyone know if they're redoing those trials with the new goalposts?
When the new goalpost looks like it might address an unmet medical need: Pretty much as soon as the patent application has been filed. If it looks like revenue, the company will either develop it or sell the IP to a company that can.
You couldn't publish something like that in a major peer-reviewed medical journal today.
Anil Potti, Sheng Wang, and many others managed to do it just fine. Where drug companies get into trouble it is usually when they hire people at hospitals/companies/universities to run sites for a clinical trial. The contracts often create huge conflicts of interest that can skew the results of the trial.
I don't think it was entirely due to drug companies. A lot of studies are proposed and led by academics with public funding. For them, the reward is the publication, so there's a big disincentive to complete studies if it looks like they aren't leading to publishable results. A couple of years ago there was a review of how the compulsory registration rules were affecting research. It found that academics were actually less likely to follow the registration rules than pharmas.
A result has to be proven by a second independent study before you can take it seriously. Instead, they would do one study, get the results they wanted, and then declare success.
If by "taken seriously" one means "approved by the FDA", then two trials is pretty much the minimum (one phase II and one phase III).
And the finisher: for years everyone who called the bubble a bubble underperformed the people who bet ever more recklessly. Calling a bubble too soon would just get you fired from your real estate/securities job: you would be scaring the customers and pissing off the partners. Calling it just right would still just piss off the partners at your company - unless you managed to convince them you were right in time for them to change course. Calling a bubble too late: you look just like everyone else, you'll catch no individual blame.
He also has a track record of running his companies into bankruptcy (4 times). On this narrow point I'll agree with him though: unless we're all planning on driving off road vehicles over a maze of potholes an extra 20 miles (to get to a bridge that hasn't fallen down yet) to work every day, rebuilding our infrastructure before 2037 seems like a good plan.
Since then they've been the ruling party (in a coalition with another party).(Not saying it needs to be the green party - just that doing away with a two party system is possible).
In countries with a party list proportional representation system (i.e., Germany) sure. 5% of the vote gets you a seat at the table. In our system voting third party in an election when your candidate is not competitive doesn't "make a point", it just bleeds support from the party (dem or rep) that is closer to your interests. If you're going to vote third party, do it in local election IF your candidate has a chance of getting elected and moving to higher office later on.
MIT researchers performed brain scans on 38 SAD patients and were able to predict with about 80% accuracy which patients would do well in cognitive behavioral therapy (CBT). Use of the scans to predict treatment outcomes improved predictions fivefold over use of a clinician's assessment alone.
If the scan is both 80% accurate and five fold better than the clinicians' assessments, then the clinicians' assessments are only 16% accurate. Unless it has already been shown that only a small percentage of SAD patients respond well to CBT, clinicians would be much better off just flipping a coin than using their own judgement. But if the percentage is small, then you can't determine the accuracy of the test by looking at just 38 patients.
Not quite. 30 cents for the filament to print one part of the stethoscope (the diaphragm). The rest of the stethoscope shown in the article was definitely not printed. It would probably be a lot cheaper to buy them in bulk on Ali Baba.
And if they had actually been pouring gallons of hydrofluoric acid into a tub they would have been dead and the entire neighborhood would have had severe lung and nerve damage.
Hydrogen fluoride does make white fumes at room temperature, though they dissipate pretty quickly (I only worked with it in small scale). For a look at a large scale HF release:
http://www.usw.org/workplaces/...
I worked in academic organic chemistry for quite a few years, and was constantly spooked by some of the careless and dangerous things organic chemists would do to speed things up. And got to see a few ambulances pull up after things went "boom". The one thing all the organic chemists were afraid of though was the pure hydrogen fluoride our lab was working with daily. People who do peptide chemistry treat their HF apparatus like an airplane: preflight safety checks every time. If we had ever had an exposure (no accidents while I was working there), we had 4l bottles of magnesium sulfate to douse ourselves with and calcium gluconate gel right at the hood. I also had MSDS and current standards of care attached to the fume hood and sterile injectable calcium gluconate, all to be brought with us to the ER. I also kept the phone number for the ER handy - and the phone number for the president our our research institute. He's a chemist and knows the president of the hospital we would be taken to, which I hoped would provide some leverage in getting the ER up to speed before the ambulance arrived.
If saving money on gas is important to you, wouldn't you be better off with a smaller can than a large car (or SUV or truck or whatever) that has a 24+ gallon tank?
Note:
which I had to drive to get to my surfing beach
Personally I can fit a 9'6" longboard in my Mazda3, but that precludes carrying anyone or much of anything else. Some folks head to the beach with a quiver.
How about this case: The airspace above private property is private up to 500 ft, according to the FAA. If Amazon wants to do drone delivery, they will have to either stay above public land or above 500 ft until they reach their destination or they will be at risk of lots of counts of trespassing.
No, the market is horrible at working things like this out. Even giant health insurance companies generally would not have access to the data they would need to separate the wheat from the chaff. And yes, look at the vitamin market. Lots of folks taking vitamins: most aren't receiving any benefit from them. But hey, if you market them, people will buy them.
UL testing, in comparison to drug testing, is child's play, super cheap, and super fast. The equivalent would be sending a drug candidate to a lab that returns a result of "hey, we looked at this for a few weeks. It didn't kill any more mice than we expected it to. Go sell your new UL approved drug". Figuring out if a new chemical entity is a useful new drug, a drug that is inferior to other treatments on the market, or a drug that does more harm than good generally takes several years and several hundred million dollars. And since the end result is almost always "No, this is not a good drug", you would actually be better off spending the money on marketing it than on continued testing. Hence the supplement industry. Why bother to prove something works if you are already allowed to sell it?
If you think pharma is asinine now, imagine what it would be like if they could just sell whatever they want.
No reason someone couldn't pay for drugs undergoing early development.
Have to disagree with you there. Here are a couple:
1. Which drugs are "newer and potentially more risky" and which are just straight up snake oil? Should both be allowed on the market, caveat emptor? How do you tell the two apart?
2. If you own a new potential drug, why even bother finishing clinical trials? You're much better off doing small trials on random molecules until one looks "promising" and then putting it up for sale. So long as you don't do more research (which would just prove that your promising drug is actually crap), you can just keep on selling it.
3. If you need a new drug, would you buy a "promising" drug or participate in a clinical trial where there's a 50% chance you will end up in the placebo wing? Would you maybe decide to do both and just not tell the folks running the trial about the other drug you are taking, thus messing up the trial? A lot of drug development efforts stall because they cannot enroll enough patients. This is especially true for cancer drugs.
Basically it boils down to this: Imagine there are 10 new drug candidates for a particular cancer that have made it through Ph 1 clinical trials. 1 of them is actually a drug worth taking, the rest would prove to be failures if they are tested sufficiently. If you let people sell unproven drugs then 10 years from now all 10 will still be on the market. 10% of the people will be getting the best drug available, 90% will be getting prescribed the failures. The little dribs and drabs of data that come back about the prescriptions won't be statistically powerful enough to figure out which drug is the good one.
Remember that, to corporate management, scientific research appears to have a record of 90% failure; i.e., 90% of funded research projects fail to produce a patentable and marketable product.
Oh, they're pretty much 100% successful at creating patents. The patents get filed before the clinical trials even get started, for the most part. It's the "safe and effective" hurdles that trip everyone up.
I'm not quite sure what your point is. Most industries spend more on revenue on marketing and overhead as a percentage of revenue than Pharma.
What is wrong with the production process at the brand name companies that they cost so much more to make?
Could you give some specifics? The specifics I can think of are that offshore generic drug factories in 3rd world countries were historically not inspected very often or very thoroughly by the FDA. So they faked quality control and shipped a lot of garbage. Hence the $500M fine for selling adulterated statins that Ranbaxy caught.
Slashdot Mirror
focused on human randomized controlled trials that were funded by the US National Heart, Lung, and Blood Institute (NHLBI). The authors conclude that registration of trials seemed to be the dominant driver of the drastic change in study results. They found no evidence that the trend could be explained by shifting levels of industry sponsorship or by changes in trial methodologies.
does anyone know if they're redoing those trials with the new goalposts?
When the new goalpost looks like it might address an unmet medical need: Pretty much as soon as the patent application has been filed. If it looks like revenue, the company will either develop it or sell the IP to a company that can.
You couldn't publish something like that in a major peer-reviewed medical journal today.
Anil Potti, Sheng Wang, and many others managed to do it just fine. Where drug companies get into trouble it is usually when they hire people at hospitals/companies/universities to run sites for a clinical trial. The contracts often create huge conflicts of interest that can skew the results of the trial.
I don't think it was entirely due to drug companies. A lot of studies are proposed and led by academics with public funding. For them, the reward is the publication, so there's a big disincentive to complete studies if it looks like they aren't leading to publishable results. A couple of years ago there was a review of how the compulsory registration rules were affecting research. It found that academics were actually less likely to follow the registration rules than pharmas.
A result has to be proven by a second independent study before you can take it seriously. Instead, they would do one study, get the results they wanted, and then declare success.
If by "taken seriously" one means "approved by the FDA", then two trials is pretty much the minimum (one phase II and one phase III).
And the finisher: for years everyone who called the bubble a bubble underperformed the people who bet ever more recklessly. Calling a bubble too soon would just get you fired from your real estate/securities job: you would be scaring the customers and pissing off the partners. Calling it just right would still just piss off the partners at your company - unless you managed to convince them you were right in time for them to change course. Calling a bubble too late: you look just like everyone else, you'll catch no individual blame.
He also has a track record of running his companies into bankruptcy (4 times). On this narrow point I'll agree with him though: unless we're all planning on driving off road vehicles over a maze of potholes an extra 20 miles (to get to a bridge that hasn't fallen down yet) to work every day, rebuilding our infrastructure before 2037 seems like a good plan.
Since then they've been the ruling party (in a coalition with another party).(Not saying it needs to be the green party - just that doing away with a two party system is possible).
In countries with a party list proportional representation system (i.e., Germany) sure. 5% of the vote gets you a seat at the table. In our system voting third party in an election when your candidate is not competitive doesn't "make a point", it just bleeds support from the party (dem or rep) that is closer to your interests. If you're going to vote third party, do it in local election IF your candidate has a chance of getting elected and moving to higher office later on.
Are you in a swing state? If not, focus on someone local.
(little track record for Carson, but then again he's not already a known-corrupt politician
If that is a necessary qualification then Walker is out.
MIT researchers performed brain scans on 38 SAD patients and were able to predict with about 80% accuracy which patients would do well in cognitive behavioral therapy (CBT). Use of the scans to predict treatment outcomes improved predictions fivefold over use of a clinician's assessment alone.
If the scan is both 80% accurate and five fold better than the clinicians' assessments, then the clinicians' assessments are only 16% accurate. Unless it has already been shown that only a small percentage of SAD patients respond well to CBT, clinicians would be much better off just flipping a coin than using their own judgement. But if the percentage is small, then you can't determine the accuracy of the test by looking at just 38 patients.
Article is fucked.
Not quite. 30 cents for the filament to print one part of the stethoscope (the diaphragm). The rest of the stethoscope shown in the article was definitely not printed. It would probably be a lot cheaper to buy them in bulk on Ali Baba.
1) not really, no. Plenty of research (on humans) finds no effect on appetite for most non-caloric sweeteners.
And if they had actually been pouring gallons of hydrofluoric acid into a tub they would have been dead and the entire neighborhood would have had severe lung and nerve damage.
it doesn't form white fuming clouds easily
Hydrogen fluoride does make white fumes at room temperature, though they dissipate pretty quickly (I only worked with it in small scale). For a look at a large scale HF release: http://www.usw.org/workplaces/...
Bingo.
I worked in academic organic chemistry for quite a few years, and was constantly spooked by some of the careless and dangerous things organic chemists would do to speed things up. And got to see a few ambulances pull up after things went "boom". The one thing all the organic chemists were afraid of though was the pure hydrogen fluoride our lab was working with daily. People who do peptide chemistry treat their HF apparatus like an airplane: preflight safety checks every time. If we had ever had an exposure (no accidents while I was working there), we had 4l bottles of magnesium sulfate to douse ourselves with and calcium gluconate gel right at the hood. I also had MSDS and current standards of care attached to the fume hood and sterile injectable calcium gluconate, all to be brought with us to the ER. I also kept the phone number for the ER handy - and the phone number for the president our our research institute. He's a chemist and knows the president of the hospital we would be taken to, which I hoped would provide some leverage in getting the ER up to speed before the ambulance arrived.
Why look at raw data from just the USA instead of global when the topic is a global phenomenon?
Says the anonymous coward
If saving money on gas is important to you, wouldn't you be better off with a smaller can than a large car (or SUV or truck or whatever) that has a 24+ gallon tank?
Note:
which I had to drive to get to my surfing beach
Personally I can fit a 9'6" longboard in my Mazda3, but that precludes carrying anyone or much of anything else. Some folks head to the beach with a quiver.
How about this case: The airspace above private property is private up to 500 ft, according to the FAA. If Amazon wants to do drone delivery, they will have to either stay above public land or above 500 ft until they reach their destination or they will be at risk of lots of counts of trespassing.
If you think pharma is asinine now, imagine what it would be like if they could just sell whatever they want.
No reason someone couldn't pay for drugs undergoing early development.
Have to disagree with you there. Here are a couple:
1. Which drugs are "newer and potentially more risky" and which are just straight up snake oil? Should both be allowed on the market, caveat emptor? How do you tell the two apart?
2. If you own a new potential drug, why even bother finishing clinical trials? You're much better off doing small trials on random molecules until one looks "promising" and then putting it up for sale. So long as you don't do more research (which would just prove that your promising drug is actually crap), you can just keep on selling it.
3. If you need a new drug, would you buy a "promising" drug or participate in a clinical trial where there's a 50% chance you will end up in the placebo wing? Would you maybe decide to do both and just not tell the folks running the trial about the other drug you are taking, thus messing up the trial? A lot of drug development efforts stall because they cannot enroll enough patients. This is especially true for cancer drugs.
Basically it boils down to this: Imagine there are 10 new drug candidates for a particular cancer that have made it through Ph 1 clinical trials. 1 of them is actually a drug worth taking, the rest would prove to be failures if they are tested sufficiently. If you let people sell unproven drugs then 10 years from now all 10 will still be on the market. 10% of the people will be getting the best drug available, 90% will be getting prescribed the failures. The little dribs and drabs of data that come back about the prescriptions won't be statistically powerful enough to figure out which drug is the good one.
Remember that, to corporate management, scientific research appears to have a record of 90% failure; i.e., 90% of funded research projects fail to produce a patentable and marketable product.
Oh, they're pretty much 100% successful at creating patents. The patents get filed before the clinical trials even get started, for the most part. It's the "safe and effective" hurdles that trip everyone up.
What is wrong with the production process at the brand name companies that they cost so much more to make?
Could you give some specifics? The specifics I can think of are that offshore generic drug factories in 3rd world countries were historically not inspected very often or very thoroughly by the FDA. So they faked quality control and shipped a lot of garbage. Hence the $500M fine for selling adulterated statins that Ranbaxy caught.
About 18% I think, much higher than pretty much any other industry outside of semiconductors. "Big Innovators" like Apple spend about 2% on R%D.