Quacks & Pseudoscience

[milo]

This thread belongs over here

http://www.glory-glory.co.uk/community/threads/employment-law-pseudoscience.8126/

 

[monkeybarry]

This thread belongs over here

http://www.glory-glory.co.uk/community/threads/employment-law-pseudoscience.8126/

Touche!

Be a darling and move it.
Chin chin

 

[thfcsteff]

Not followed this whole thread in detail beyond the first two pages, other than seeing Scara only appears to believe in medical benefits if they are sanctioned by some chap in a coat with an 'MD' stuck on the end of his name whose entire practice right be funded/supported by a drug company (who, of course, are operating in pure benevolence and have no interest whatsoever in only promoting the line of products they manufacture).

I have used electric acupuncture twice, each time in conjunction with rest, anti-inflammatories, ice and swimming pool stretches/exercises, for torn calf muscles. Very helpful indeed.

I agree wholeheartedly with Scara that moderation is the key to achieving a healthy lifestyle (though I would add it's a bloody good idea to limit your carb/sugar intake the older you get, or at least be smart about timing when you eat them) and I think everyone should get some form of exercise 6 days a week with maybe one day a week of loafing if necessary.

I do, however, think there are several ways to teat conditions, and acupuncture is absolutely one of them. Understand the legal thing from your perspective. I hope it sorted out for all concerned.

 

[scaramanga]

Not followed this whole thread in detail beyond the first two pages, other than seeing Scara only appears to believe in medical benefits if they are sanctioned by some chap in a coat with an 'MD' stuck on the end of his name whose entire practice right be funded/supported by a drug company (who, of course, are operating in pure benevolence and have no interest whatsoever in only promoting the line of products they manufacture).

I think you've misunderstood my position (or, more likely, I've failed to make it clrear).

I only believe in medical benefits that are proven to work. I dismiss those yet to be proven and ridicule those proven not to work.

Acupuncture is no better than sticking needles in a person at random. I can say that with absolute certainty because all the evidence of all the trials on acupuncture prove that. There is no level of anecdotal "evidence" or confirmation bias that can weigh up against real testable evidence.

 

[thfcsteff]

I think you've misunderstood my position (or, more likely, I've failed to make it clrear).

I only believe in medical benefits that are proven to work. I dismiss those yet to be proven and ridicule those proven not to work.

Acupuncture is no better than sticking needles in a person at random. I can say that with absolute certainty because all the evidence of all the trials on acupuncture prove that. There is no level of anecdotal "evidence" or confirmation bias that can weigh up against real testable evidence.

Apologies for misinterpretation.
I think the one thing I would say here is that if , say, Pfizer thought there were pottable money to be made from acupuncture (i.e. they could sell the needles/home-kits and people could self-administer) then studies would be, hmmm, done. However it remains something which still requires a practitioner and a relatively low-material-based cure.
Hope it worked out for you.

 

[scaramanga]

Apologies for misinterpretation.
I think the one thing I would say here is that if , say, Pfizer thought there were pottable money to be made from acupuncture (i.e. they could sell the needles/home-kits and people could self-administer) then studies would be, hmmm, done. However it remains something which still requires a practitioner and a relatively low-material-based cure.
Hope it worked out for you.

Pfizer (being a company that produces real medicine) is very heavily regulated and cannot promote treatments without overwhelming evidence that they work.

That's why Pfizer aren't involved in acupuncture, not because of a lack of money. There's clearly a lot of money in it because there are a lot of very rich charlatans that practise it.

 

[ricky2tricky4city]

Pfizer (being a company that produces real medicine) is very heavily regulated and cannot promote treatments without overwhelming evidence that they work.

That's why Pfizer aren't involved in acupuncture, not because of a lack of money. There's clearly a lot of money in it because there are a lot of very rich charlatans that practise it.

The only problem with that, is many things that are getting medicine, don't require medicine at all. They are being mistreated or misprescribed.

 

[scaramanga]

The only problem with that, is many things that are getting medicine, don't require medicine at all. They are being mistreated or misprescribed.

That's not down to the drug companies making the medicine.

They make treatments for certain conditions or sets of conditions, it's up to doctors to do the rest.

 

[braineclipse]

Not followed this whole thread in detail beyond the first two pages, other than seeing Scara only appears to believe in medical benefits if they are sanctioned by some chap in a coat with an 'MD' stuck on the end of his name whose entire practice right be funded/supported by a drug company (who, of course, are operating in pure benevolence and have no interest whatsoever in only promoting the line of products they manufacture).

I have used electric acupuncture twice, each time in conjunction with rest, anti-inflammatories, ice and swimming pool stretches/exercises, for torn calf muscles. Very helpful indeed.

I agree wholeheartedly with Scara that moderation is the key to achieving a healthy lifestyle (though I would add it's a bloody good idea to limit your carb/sugar intake the older you get, or at least be smart about timing when you eat them) and I think everyone should get some form of exercise 6 days a week with maybe one day a week of loafing if necessary.

I do, however, think there are several ways to teat conditions, and acupuncture is absolutely one of them. Understand the legal thing from your perspective. I hope it sorted out for all concerned.

The money argument is old and tired at this point. The alternative medicine industry is a huge industry that's less regulated than big pharma and making tons of money. Many of the vilified big pharma companies are also doing vitamin, supplement and herbal stuff for example because it's such an easy cash cow for them with little to no regulation in way too many countries.

Compared to other big industries I'm not sure big pharma is that much worse. Are they worse than big oil and gas? Big weapons? Even your tech companies - are they worse than companies that produce their products in developing countries with suicide nets outside the factory buildings? Are they worse than big clothing and the way they exploit workers and push warped body images on young people? Etc etc etc...

Apologies for misinterpretation.
I think the one thing I would say here is that if , say, Pfizer thought there were pottable money to be made from acupuncture (i.e. they could sell the needles/home-kits and people could self-administer) then studies would be, hmmm, done. However it remains something which still requires a practitioner and a relatively low-material-based cure.
Hope it worked out for you.

Studies have been done and are being done. Yes, often by those that make money off acupuncture... And often the quality of those studies is poor. I think it's quite telling that those that make money from it choose to perform poorly designed studies instead of well controlled studies, but that's a bit speculative of course.

It's true that it's not as interesting to big pharma as pills and injections. Similar issues are seen with other non-pharmalogical treatments in other areas too. Though the evidence that is there points pretty clearly towards what Scara is saying.

 

[braineclipse]

Pfizer (being a company that produces real medicine) is very heavily regulated and cannot promote treatments without overwhelming evidence that they work.

That's why Pfizer aren't involved in acupuncture, not because of a lack of money. There's clearly a lot of money in it because there are a lot of very rich charlatans that practise it.

Overwhelming is unfortunately not true. The evaluation of evidence is unfortunately not stringent enough (imo). Researcher bias, file cabinet effect etc and these companies can get away with stuff they shouldn't get away with.

This is illustrated quite well in some of the settlements they've paid in the past over what seems like criminal activity.

For me the oversight is not strong enough. Though there are improvements. Europe seems to be doing a good job in this regard actually, which is good because the US has been slacking off on this one unfortunately. This gets back to money in politics that we talked about in the Trump thread. Big Pharma has a ridiculous influence over US politicians and it's part of why they get away with so much stuff they really shouldn't get away with.

That's not down to the drug companies making the medicine.

They make treatments for certain conditions or sets of conditions, it's up to doctors to do the rest.

It's down to the drug companies when they push diagnostic agendas in directions that help their bottom line. It's down to the drug companies when they bribe medical doctors and researchers. It's down to the drug companies when they make ads aimed at the general population influencing their opinions on illness and treatment as lay people.

Again, the reasons they're able to do this is of course...

 

[scaramanga]

Overwhelming is unfortunately not true. The evaluation of evidence is unfortunately not stringent enough (imo). Researcher bias, file cabinet effect etc and these companies can get away with stuff they shouldn't get away with.

This is illustrated quite well in some of the settlements they've paid in the past over what seems like criminal activity.

For me the oversight is not strong enough. Though there are improvements. Europe seems to be doing a good job in this regard actually, which is good because the US has been slacking off on this one unfortunately. This gets back to money in politics that we talked about in the Trump thread. Big Pharma has a ridiculous influence over US politicians and it's part of why they get away with so much stuff they really shouldn't get away with.

That's interesting. I can't say I've heard of many cases where medicine has been found to not work.

I've seen plenty of uncompetitive practices which should be dealt with like it should in any other market. I've seen cases where safety controls were not as tight as they could/should have been and again, they are dealt with by the authorities.

It's down to the drug companies when they push diagnostic agendas in directions that help their bottom line. It's down to the drug companies when they bribe medical doctors and researchers. It's down to the drug companies when they make ads aimed at the general population influencing their opinions on illness and treatment as lay people.

Again, the reasons they're able to do this is of course...

Doctors are the ones who take the Hippocratic oath. I tell everyone who will listen that my company's products are the best on the market and the only ones that will do the job. At times I tender for work when someone else's product would do a better job - that's just part of being in business.

Last time I read into this heavily (about 7 or 8 years ago), doctors were not getting the training required to be able to properly analyse the studies presented to them. I believe this has now changed. There's no excuse for them or researchers taking bribes, I find it hard to imagine that it's commonplace (although I'm probably wrong).

 

[braineclipse]

That's interesting. I can't say I've heard of many cases where medicine has been found to not work.

I've seen plenty of uncompetitive practices which should be dealt with like it should in any other market. I've seen cases where safety controls were not as tight as they could/should have been and again, they are dealt with by the authorities.

The evidence material is too small, and too much of the research is controlled by the pharmaceutical industry. As long as they can choose what to publish and what not too it should be pretty obvious why we could be in trouble... There have been moves to correct this, but it's not moving fast enough for my liking.

Mental health remains the topic I'm closest to up to date on (though I'm not up to date). And there have been serious questions asked by serious people about a lot of the pharmacological treatments in psychiatry. Even the newer one's.

Doctors are the ones who take the Hippocratic oath. I tell everyone who will listen that my company's products are the best on the market and the only ones that will do the job. At times I tender for work when someone else's product would do a better job - that's just part of being in business.

Last time I read into this heavily (about 7 or 8 years ago), doctors were not getting the training required to be able to properly analyse the studies presented to them. I believe this has now changed. There's no excuse for them or researchers taking bribes, I find it hard to imagine that it's commonplace (although I'm probably wrong).

John Oliver did a decent take on this on his last week tonight show I thought:

Bribes might be me being a bit harsh... I don't know, I use the word lightly sometimes I think. But that the US pharma rep way of doing things is ethically questionable and damaging seems difficult to question.

I think it's a bit naive to just say that doctors shouldn't let themselves be influenced. We know enough about how human thinking works to know that.

 

[Millsy_Yiddo]

I work in R&D for a drug company.

Some stuff in that has been mentioned is correct, some stuff is nonsense.

Bottom line, I'm with @scaramanga. A drug company can't market a drug without showing through one or a number of correctly powered clinical studies that the drug works better than placebo or equal/better than equivalent competitor product. It's incredibly strict no matter who you are.

I've seen loads of development programs stopped due to lack of safety/efficacy in clinic (before even submitting to FDA/MHRA/whoever). Seen some rejected by FDA/MHRA or other even though studies have passed due to them not being powered correctly. I've never seen anything approved without adequate statistically reviewed and approved evidence that the drug works.

 

[braineclipse]

I work in R&D for a drug company.

Some stuff in that has been mentioned is correct, some stuff is nonsense.

Bottom line, I'm with @scaramanga. A drug company can't market a drug without showing through one or a number of correctly powered clinical studies that the drug works better than placebo or equal/better than equivalent competitor product. It's incredibly strict no matter who you are.

I've seen loads of development programs stopped due to lack of safety/efficacy in clinic (before even submitting to FDA/MHRA/whoever). Seen some rejected by FDA/MHRA or other even though studies have passed due to them not being powered correctly. I've never seen anything approved without adequate statistically reviewed and approved evidence that the drug works.

Development stopping because of a lack of safety or efficacy is obviously the way it should be.

I'm not sure I can accept "incredibly strict". I heard a claim that two RCTs showing positive results is enough. If drug companies themselves can shelf studies that show no effect that's far from "incredibly strict". Though I realize the ability to do so has been limited somewhat in recent years.

Any views on psychiatric pharma? Seems to be a lot of valid criticism aimed both at methodological research issues as well as questionable marketing practices and overall evaluation of evidence.

 

[Millsy_Yiddo]

Development stopping because of a lack of safety or efficacy is obviously the way it should be.

I'm not sure I can accept "incredibly strict". I heard a claim that two RCTs showing positive results is enough. If drug companies themselves can shelf studies that show no effect that's far from "incredibly strict". Though I realize the ability to do so has been limited somewhat in recent years.

Any views on psychiatric pharma? Seems to be a lot of valid criticism aimed both at methodological research issues as well as questionable marketing practices and overall evaluation of evidence.

It depends on the type of drug and is all based on the risk to safety of the patient. One clinical trial is enough for a bioequivalence study where you're taking a reference drug that is already on the market and all you have to show is that blood levels are equal to that of the reference drug. For a new chemical entity that is being taken from conception through to commercialisation, if you take into account the drug substance trials you are literally talking about upwards of 100 studies. The phase 3 studies that are the final piece are also very large.

I'm not sure what point you're trying to make regarding drug companies being able to shelve studies that show no effect? To start a clinical study the company has to submit an IND (or similar) to FDA (or similar). This details what they are doing and why. So, even if the company shelves the study, FDA are aware that the study was started. If they were to continue development of the same drug, FDA will take previous studies into account during their review. So there's no way a drugs company can 'hide' results that they didn't like. I'm not sure if that is what you were suggesting?

I don't have any experience in psychiatric pharma, although the company I work for does have some products. All I know is that the brain is a completely different ball game to 'normal' pharmaceutical development as you can probably imagine. I don't know enough about it to comment but I would assume the potential variation in efficacy from patient to patient must be massive.

 

[braineclipse]

It depends on the type of drug and is all based on the risk to safety of the patient. One clinical trial is enough for a bioequivalence study where you're taking a reference drug that is already on the market and all you have to show is that blood levels are equal to that of the reference drug. For a new chemical entity that is being taken from conception through to commercialisation, if you take into account the drug substance trials you are literally talking about upwards of 100 studies. The phase 3 studies that are the final piece are also very large.

I'm not sure what point you're trying to make regarding drug companies being able to shelve studies that show no effect? To start a clinical study the company has to submit an IND (or similar) to FDA (or similar). This details what they are doing and why. So, even if the company shelves the study, FDA are aware that the study was started. If they were to continue development of the same drug, FDA will take previously completed studies into account during their review. So there's no way a drugs company can 'hide' results that they didn't like. I'm not sure if that is what you were suggesting?

I don't have any experience in psychiatric pharma, although the company I work for does have some products. All I know is that the brain is a completely different ball game to 'normal' pharmaceutical development as you can probably imagine. I don't know enough about it to comment but I would assume the potential variation in efficacy from patient to patient must be massive.

How about for a known chemical entity that is going to be marketed for a new illness?
How about a slight tweak of a chemical entity to gain a new patent?

How long has the IND or similar to FDA or similar regulations been in place? My understanding has been that this has been a rather recent development (hence my comment about shelving studies has been limited). My understanding has been that hiding results the company does not like certainly has been possible.

I agree that psychiatric pharma is a completely different ball game to most other pharmaceuticals.

 

[Millsy_Yiddo]

How about for a known chemical entity that is going to be marketed for a new illness?
How about a slight tweak of a chemical entity to gain a new patent?

How long has the IND or similar to FDA or similar regulations been in place? My understanding has been that this has been a rather recent development (hence my comment about shelving studies has been limited). My understanding has been that hiding results the company does not like certainly has been possible.

I agree that psychiatric pharma is a completely different ball game to most other pharmaceuticals.

How about for a known chemical entity that is going to be marketed for a new illness?

At minimum you'd need to go back into Phase 3, which would mean you'd need a repeat end of Phase 2 meeting with FDA. As part of the meeting package you'd detail that you want to go for a new indication. The clinical protocol & plan would be included in the meeting package. FDA would then either agree or disagree with your proposal. If they agree you'd do the Phase 3 study in patients with the new illness. If they disagree then you could be back into Phase 2 or even Phase 1 depending on their position.

How about a slight tweak of a chemical entity to gain a new patent?

Again depends on the type of the tweak, but if you are altering the drugs form in a way that could impact its efficacy or safety the FDA would expect to see a full and comprehensive clinical plan. You could looking at going back to P1.

Basically the FDA guides the company to the type of studies required. You can ignore their advice and stick with your original plan, but then the likelihood of getting approval is pretty much nil.

The Thalidomide tragedy prompted some amendments to the food and drug act which meant you had to show safety and efficacy before approval (previously you only had to show safety). I think the amendments were passed in the 60s. It was the basis for the introduction of INDs in my understanding.

 

[braineclipse]

@Millsy_Yiddo @scaramanga

An excerpt from Ben Goldacre's book Bad Pharma: http://www.scientificamerican.com/a...unded-research-cherry-picks-positive-results/

Rather long for an internet link in a forum discussion, but I honestly don't think you have to read all of it even to get the point he is making. Which is essentially the point I've tried to make, though obviously not as thoroughly as Goldacre makes it.

Small part through the article he summarizes:

I am setting out this evidence at length because I want to be absolutely clear that there is no doubt on the issue. Industry sponsored trials give favorable results, and that is not my opinion, or a hunch from the occasional passing study. This is a very well-documented problem, and it has been researched extensively, without anybody stepping out to take effective action, as we shall see.

How this is not hugely problematic I don't understand... Again, I believe steps are being taken to correct this. But too late and the effectiveness of those steps cannot really be judged at this point.

 

[Millsy_Yiddo]

@Millsy_Yiddo @scaramanga

An excerpt from Ben Goldacre's book Bad Pharma: http://www.scientificamerican.com/a...unded-research-cherry-picks-positive-results/

Rather long for an internet link in a forum discussion, but I honestly don't think you have to read all of it even to get the point he is making. Which is essentially the point I've tried to make, though obviously not as thoroughly as Goldacre makes it.

Small part through the article he summarizes:

I am setting out this evidence at length because I want to be absolutely clear that there is no doubt on the issue. Industry sponsored trials give favorable results, and that is not my opinion, or a hunch from the occasional passing study. This is a very well-documented problem, and it has been researched extensively, without anybody stepping out to take effective action, as we shall see.

How this is not hugely problematic I don't understand... Again, I believe steps are being taken to correct this. But too late and the effectiveness of those steps cannot really be judged at this point.

I've not read the book (I'd like to though, if I ever find the time). I skim read the article. I'd like to see more detail on the types of trial that are being run by industry verses non industry. My inclination is that they are likely to be very different. However, considering Ben Goldacre has taken the time to write a book and several newspaper columns I'd say he's probably done his homework.

I don't know of a mechanism where a company can with hold clinical data from FDA if it is not seen as favourable for an un-approved drug, due to the fact they need approval from FDA to actually carry out the study.

 

[braineclipse]

I've not read the book (I'd like to though, if I ever find the time). I skim read the article. I'd like to see more detail on the types of trial that are being run by industry verses non industry. My inclination is that they are likely to be very different. However, considering Ben Goldacre has taken the time to write a book and several newspaper columns I'd say he's probably done his homework.

I don't know of a mechanism where a company can with hold clinical data from FDA if it is not seen as favourable for an un-approved drug, due to the fact they need approval from FDA to actually carry out the study.

Bit of an understatement that... Yes he's almost certainly done his homework.

And he partly answers your question about types of studies...

It’s not ideal to lump every study of this type together in one giant spreadsheet, to produce a summary figure on publication bias, because they are all very different, in different fields, with different methods. This is a concern in many meta-analyses (though it shouldn’t be overstated: if there are lots of trials comparing one treatment against placebo, say, and they’re all using the same outcome measurement, then you might be fine just lumping them all in together).

But you can reasonably put some of these studies together in groups. The most current systematic review on publication bias, from 2010, from which the examples above are taken, draws together the evidence from various fields. Twelve comparable studies follow up conference presentations, and taken together they find that a study with a significant finding is 1.62 times more likely to be published. For the four studies taking lists of trials from before they started, overall, significant results were 2.4 times more likely to be published. Those are our best estimates of the scale of the problem. They are current, and they are damning.

Many issues not even mentioned here by Goldacre even. Like the point about placebos not showing side effects and studies using "active placebos" mimicking the side effects of the actual drugs sometimes showing less or no drug efficacy.