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Shkreli, Drug Price Gouger, Denies Fraud and Posts Bail


SoulMonster

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1 hour ago, PappyTron said:

You say that you are not happy to release such a drug ("a potentially increased "adverse side-effect profile".") and then go on to say that you are happy to release such a drug ("even if this drug now has a slight increased risk of not being as efficient for every patient or have a slight increased risk of having adverse side-effects") ; which of the two is it?

I am not questioning whether the market would want it. I am stating that it would not be responsible to release drugs to market unless they have gone through all testing protocols, and I do not believe that it would be a good idea to reduce the testing protocols simply to get the drug to market quicker and/or cheaper.

You say that litigation is not much of a problem in the drugs industry, which surprises me, given how many Billions of Dollars lawsuits cost. Just look at things such as Lipitor, for an example; something that was thoroughly tested yet was revealed to be linked with giving its patients severe diabetes. Who would be responsible for such lawsuits if the testing protocols were relaxed so that drugs could enter the market quicker and at a cheaper point? Should Pfizer et al be forced to cover lawsuits from your proposed relaxing of testing? Moreover, one of the best defenses that a patent holder of a drug has is to sue the companies who make generics and the best defense that the makers of the generics have is to sue the patent holders; in the US at least the FDA is required, by Federal law, to halt approval of drugs for 2.5 years when there is litigation underway. Heck, in the US holders of drug patents pay the generics companies to hold off on bringing their copies to market!

I'm not sure that the market does have a low acceptance rate of copy medicine; all research shows that branded drugs lose about 70-80% of their market share within the first few months of a generic copy coming about. I would suggest that any generic drug which is able to cannibalise 80% of the market share in a matter of a few months is certainly not struggling to gain traction due to patients and doctors having a lack of trust in it.

 

It is the one where you don't leave out the fact that I would ONLY accept a drug with potentially less efficacy and adverse side effects IF it would result in many more patients being treated. You simply asked me if I would be happy releasing a drug to market with side-effects, not mentiong that the premise is that the drug would be accessible to many more patients.

Again, the market already accepts that we can't test the drugs to the point of being 100 % certain they are safe. It would not be irresponsible to accept quicker regulatory pathways for certain drugs (notably for those where no other treatments exists and the outcome of not being treated is death) where the result would guaranteed be MANY more being treated while at the worst only a VERY FEW not have an effect of the medicine or, at the very worst, would experience side-effects. It is an easy cost-benefit analysis. Maintaining a system that lets millions die or suffer from not proper medication because they don't have access to necesarry medicine, is what is irresponsible.

I don't see any reason why there should be any changes to who would be held responsible for any approved drugs turning out to have unknown side-effects, if the system was less rigid and smarter.

Again, you are confusing generics for biosimilars. These are not the same. The market has a very low acceptance for biosimilars.

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9 hours ago, SoulMonster said:

It is the one where you don't leave out the fact that I would ONLY accept a drug with potentially less efficacy and adverse side effects IF it would result in many more patients being treated. You simply asked me if I would be happy releasing a drug to market with side-effects, not mentiong that the premise is that the drug would be accessible to many more patients.

Again, the market already accepts that we can't test the drugs to the point of being 100 % certain they are safe. It would not be irresponsible to accept quicker regulatory pathways for certain drugs (notably for those where no other treatments exists and the outcome of not being treated is death) where the result would guaranteed be MANY more being treated while at the worst only a VERY FEW not have an effect of the medicine or, at the very worst, would experience side-effects. It is an easy cost-benefit analysis. Maintaining a system that lets millions die or suffer from not proper medication because they don't have access to necesarry medicine, is what is irresponsible.

I don't see any reason why there should be any changes to who would be held responsible for any approved drugs turning out to have unknown side-effects, if the system was less rigid and smarter.

Again, you are confusing generics for biosimilars. These are not the same. The market has a very low acceptance for biosimilars.

Right, so you are happy for a drug to be released which may not be fully tested and may have lethal side effects as long as it can be taken by more people along the way.

I'm aware that no drug is 100% safe, and obviously so. Testing drugs to the best of our ability is not irresponsible, even if it takes a long time. You could make the argument that nations not providing for their sick is irresponsible, but not for ensuring that drugs are tested fully. As it stands, even drugs which are tested for years often end up giving people extremely dangerous and unforeseen side effects; Lipitor being a prime example.

"I don't see any reason why there should be any changes to who would be held responsible for any approved drugs turning out to have unknown side-effects, if the system was less rigid and smarter." - So, you want to force pharmaceutical companies to release drugs into the market with relaxed testing protocols and then have them cut adrift for potential lawsuits resulting from potentially unsafe drugs?

If the market has a low threshold for biosimilars then surely that is indicative that something does not sit right with them? America is a capitalistic market where the product will out; that people don't want biosimilars tells its own story. In your vision for how the drugs market should be we wouldn't actually need generic companies to make biosimilars as they could simply make the real thing. I mean, I am assuming that companies make biosimilars of popular drugs because they don't have the ability to just make the actual drug in the first place.

At the end of the day, drugs companies invest Billions into their products and deserve to have the fruit of their labour. If governments cared so much then they are free to subsidise, or even cover completely, the cost of any and all medication for their citizens, no matter the cost. Forcing drugs companies to cut their testing protocols simply so that drugs can reach more people, even if those drugs may end up having an increased possibility of having potentially dangerous or even lethal side-effects, is wholly irresponsible.

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On 7.2.2016 at 8:25 PM, PappyTron said:

Right, so you are happy for a drug to be released which may not be fully tested and may have lethal side effects as long as it can be taken by more people along the way.

I'm aware that no drug is 100% safe, and obviously so. Testing drugs to the best of our ability is not irresponsible, even if it takes a long time. You could make the argument that nations not providing for their sick is irresponsible, but not for ensuring that drugs are tested fully. As it stands, even drugs which are tested for years often end up giving people extremely dangerous and unforeseen side effects; Lipitor being a prime example.

"I don't see any reason why there should be any changes to who would be held responsible for any approved drugs turning out to have unknown side-effects, if the system was less rigid and smarter." - So, you want to force pharmaceutical companies to release drugs into the market with relaxed testing protocols and then have them cut adrift for potential lawsuits resulting from potentially unsafe drugs?

If the market has a low threshold for biosimilars then surely that is indicative that something does not sit right with them? America is a capitalistic market where the product will out; that people don't want biosimilars tells its own story. In your vision for how the drugs market should be we wouldn't actually need generic companies to make biosimilars as they could simply make the real thing. I mean, I am assuming that companies make biosimilars of popular drugs because they don't have the ability to just make the actual drug in the first place.

At the end of the day, drugs companies invest Billions into their products and deserve to have the fruit of their labour. If governments cared so much then they are free to subsidise, or even cover completely, the cost of any and all medication for their citizens, no matter the cost. Forcing drugs companies to cut their testing protocols simply so that drugs can reach more people, even if those drugs may end up having an increased possibility of having potentially dangerous or even lethal side-effects, is wholly irresponsible.

Yes, I am happy to accept a new system that is smarter and allows shorter development times by foregoing some clinical and pre-clinical experiments for some drugs when the net result is more people better off with it.

I wouldn't say new drugs "often" end up with "extremely dangerous and unforeseen side effects". At least not to the extent of them being withdrawn from the market, which would mean that they don't have any positive net effect at all. I think the number of drugs that are withdrawn is 1-2 %. The rest are deemed to work exactly as determined during the approval-process, or, for a minority, is shown to have unknown side-effecs that range the whole gamut from completely irrelevant to very dangerous under certain circumstances. But again, in those cases where the post-approval safety monitoring system discovers side-effects, these are very rarely so problematic that the drug can't be used anymore and must be taken off market.

The reason biosimilars is still in its early stages is varied and includes lack of regulatory pathways for their approval (which was only recently established by FDA in the US!), a regulatory pathway that makes it excessively expensive to get a biosimilar drug approved, strong opposition from originator drug companies which has included advertisements against competitive biosimilars (even to the point of some having advertisements withdrawn because they violated anti-competition laws!) and strong lobbying directly towards the Senate and FDA, and skepticism among doctors and comsumers against copy drugs which are consideres either less effective (helped by originator campaigns like "Similar but not the same"), or downright dangerous. Patent lawsuits are of less importance.

I have never argued that drug companies shouldn't enjoy the fruit of their labour. With margins above 90 % on some drugs, with multi-billion revenues, with very well-compansated executives, and with high profits, I think it is without doubt that they indeed do and can afford a little bit more competition. In fact, making the drug development pathway shorter, would mean they could also keep their margins while still cutting exit-prices on drugs. More importantly than protecting big pharma is to protect patients. And this would definitely benefits patients across the world. The ones that would primarily lose from less requirements on certain drugs in development, would be ccompanies offering services in clinical and pre-clinical trials.

No one is forcing anyone here. Pharma would still be able to do as much clinical tests as they would like. Already today they are free to do any trials they want beyond what is required by FDA (and often they don't really know what FDA requires and reluctantly do a lot more just to be sure they have enough for approval! Which again highlights how bad the system works). The difference would be that FDA/EMA wouldn't require the same amount of data for approval for some drugs and the companies could then choose to do less.

Again, what is iresponsible is stubbornly and ignorantly clinging to a system that can be improved with the net result that more people would be better off. The reason why you don't see this is an inflated belief in the amount of drugs that with the current system are discovered post-approval to have side-effects to the point of the drug not doing anything good, not accepting the extent to which the high costs of many drugs leave huge tracts of patients untreated with the current system, and a lack of understanding of the redundancy of pre-clinical and clinical trials that are required for approval of especially biosimilars.

The reasons why this system is maintained are people sharing your belief that any loosening of its mindless rigidity would lead to devastation through lots of unsafe drugs on the market, and srong lobbying pressure from big pharma who benefits from a system that prevents smaller biotech and pharma, especially biosimilar companies, from getting their drugs to market because of the very high costs involved. In the end it is the patients who lose.

 

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Just a short apropos on originator drugs companies resistance to the coming of biosimilars: Celltrion's biosimilar Inflectra has today been suggested for approval by independent FDA advisors despite strong opposition from J&J who owns the originator version of this drug, Remicade, a drug that brings in USD 5.4 billion in annual revenues. J&J attempted to argue that Celltrion (and their partner Pfizer) had not adequately demonstrated that Inflectra was not safe to use, saying that the clinical data supplied by Celltrion "do not adequately address residual uncertainty regarding use in inflammatory bowel disease". FDA disagreed arguing that requiring biosimilar developers to conduct randomized clinical trials in every potential indication would run counter to the spirit of FDA policy. This is an example of fierce opposition from originator companies who fear the competition of biosimilars, taking advantage of the vague guidelines that exist when it comes to clinical requirements in biosimilars (and NDA) drug approval applications. Bravo, FDA!

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10 hours ago, SoulMonster said:

Yes, I am happy to accept a new system that is smarter and allows shorter development times by foregoing some clinical and pre-clinical experiments for some drugs when the net result is more people better off with it.

I wouldn't say new drugs "often" end up with "extremely dangerous and unforeseen side effects". At least not to the extent of them being withdrawn from the market, which would mean that they don't have any positive net effect at all. I think the number of drugs that are withdrawn is 1-2 %. The rest are deemed to work exactly as determined during the approval-process, or, for a minority, is shown to have unknown side-effecs that range the whole gamut from completely irrelevant to very dangerous under certain circumstances. But again, in those cases where the post-approval safety monitoring system discovers side-effects, these are very rarely so problematic that the drug can't be used anymore and must be taken off market.

The reason biosimilars is still in its early stages is varied and includes lack of regulatory pathways for their approval (which was only recently established by FDA in the US!), a regulatory pathway that makes it excessively expensive to get a biosimilar drug approved, strong opposition from originator drug companies which has included advertisements against competitive biosimilars (even to the point of some having advertisements withdrawn because they violated anti-competition laws!) and strong lobbying directly towards the Senate and FDA, and skepticism among doctors and comsumers against copy drugs which are consideres either less effective (helped by originator campaigns like "Similar but not the same"), or downright dangerous. Patent lawsuits are of less importance.

I have never argued that drug companies shouldn't enjoy the fruit of their labour. With margins above 90 % on some drugs, with multi-billion revenues, with very well-compansated executives, and with high profits, I think it is without doubt that they indeed do and can afford a little bit more competition. In fact, making the drug development pathway shorter, would mean they could also keep their margins while still cutting exit-prices on drugs. More importantly than protecting big pharma is to protect patients. And this would definitely benefits patients across the world. The ones that would primarily lose from less requirements on certain drugs in development, would be ccompanies offering services in clinical and pre-clinical trials.

No one is forcing anyone here. Pharma would still be able to do as much clinical tests as they would like. Already today they are free to do any trials they want beyond what is required by FDA (and often they don't really know what FDA requires and reluctantly do a lot more just to be sure they have enough for approval! Which again highlights how bad the system works). The difference would be that FDA/EMA wouldn't require the same amount of data for approval for some drugs and the companies could then choose to do less.

Again, what is iresponsible is stubbornly and ignorantly clinging to a system that can be improved with the net result that more people would be better off. The reason why you don't see this is an inflated belief in the amount of drugs that with the current system are discovered post-approval to have side-effects to the point of the drug not doing anything good, not accepting the extent to which the high costs of many drugs leave huge tracts of patients untreated with the current system, and a lack of understanding of the redundancy of pre-clinical and clinical trials that are required for approval of especially biosimilars.

The reasons why this system is maintained are people sharing your belief that any loosening of its mindless rigidity would lead to devastation through lots of unsafe drugs on the market, and srong lobbying pressure from big pharma who benefits from a system that prevents smaller biotech and pharma, especially biosimilar companies, from getting their drugs to market because of the very high costs involved. In the end it is the patients who lose.

 

 

 

Quote

The reasons why this system is maintained are people sharing your belief that any loosening of its mindless rigidity

 

Oh, well if you see me, of all people, as someone who is nothing but "mindlessly rigid" then there is nothing else to say on the subject.

Edited by PappyTron
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13 hours ago, PappyTron said:

 

 

 

Oh, well if you see me, of all people, as someone who is nothing but "mindlessly rigid" then there is nothing else to say on the subject.

No, I was referring to the current regulatory system as being "mindlessly rigid", not you. I fully understand that most people would be reluctant to make any changes that could potentially lead to drugs being less safe. They just don't take into account the positive effects such changes could make to drug access across the globe, and they tend to exaggerate the negative effect of modest but clever changes to the regulatory requirements.

I am not the only person calling for a revision in drug development pathways, there was an interesting article in Nature in 2004, if I remember correctly, that went in great detail on how few of the current requirements are actually evidence-based and not just the opinions of regulatory KOLs, and thus why the system should be revamped so that new drugs could hit the market sooner and cheaper.

I guess the average cost of getting a drug to market today is about USD 1500 million. That's a lot of costs to recuperate on sales in the limited period where an originator drug rules the market! The awful result of this is that pharma companies don't bother to develop drugs for markets less than 1500 million, it wouldn't make economic sense. This is a huge problem to all patients of rarer diseases, or patients of those diseases that primarily affect poor people, or patients of diseases that aren't chronic (which is why so few pharam companies bothers to develop new antibiotics, despite the huge need -- they simply can't cover the development expenses on medicine tha actually quickly heal their patients and will only be used as a last-resort approach when all conventonal antibiotics have failed). Anyway, these high costs of development is the reason why pharma companies have margins above 90 % on their drugs. They need to cover these 1500 million in costs, finance future expensive drug developments, and have a profit in the end.

When copy drugs hit the market we know from small molecule copy drugs (= generics) that the competition will lower the prices by 30-70 %. So they have a fairly short time to recuperate their losses and make their profit. A cheaper regulatory process, more evidence-based, and smarter, could reduce the costs of developing new drugs substantially, with only insiginificant changes to the risk profile of a new drug. This would mean pharma could reduce margins, and hence the exit-price of the drugs, and still, when all the prior costs are accounted for, end up with the same profit. The existing drugs could not onæy become accessible to larger groups of patients, but pharma could also afford to develop drugs for neglected diseases.

But also the developer of copy drugs faces expensive development, not only the originatorm especially so for large molecule copy drugs (=biosimilars) that due to their complexity requires much more pre-clinical data in their approval process. They typically don't need to demonstrate the same efficacy and safety profile as the originator drug, but instead focus on proving bioequivalence (that the copy and the proginator is the same (mix of) chemical compunds), yet the average costs of developing a biosimilar drug is still 500-750 million (!). Okay, you might think, that is only half of what the originator drug costs, what is the problem? The problem is that when they launch their biosmilar, they have a strong, established competitor in the market they have to compete with. They don't have an open market and with exclusivity so they can set the margins more or less where they want them. They have had less costs in development, but will probably have much less revenues due to fierce competition. So they can't lower the prices to the same extent as generics have been doing this last decades, and hence we don't expect to see the same cut throat pricing competition leading to the same large reductions in drug exit-prices. Bt there will still be some, as we see for insulin biosimilars.

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9 hours ago, SoulMonster said:

No, I was referring to the current regulatory system as being "mindlessly rigid", not you. I fully understand that most people would be reluctant to make any changes that could potentially lead to drugs being less safe. They just don't take into account the positive effects such changes could make to drug access across the globe, and they tend to exaggerate the negative effect of modest but clever changes to the regulatory requirements.

I am not the only person calling for a revision in drug development pathways, there was an interesting article in Nature in 2004, if I remember correctly, that went in great detail on how few of the current requirements are actually evidence-based and not just the opinions of regulatory KOLs, and thus why the system should be revamped so that new drugs could hit the market sooner and cheaper.

I guess the average cost of getting a drug to market today is about USD 1500 million. That's a lot of costs to recuperate on sales in the limited period where an originator drug rules the market! The awful result of this is that pharma companies don't bother to develop drugs for markets less than 1500 million, it wouldn't make economic sense. This is a huge problem to all patients of rarer diseases, or patients of those diseases that primarily affect poor people, or patients of diseases that aren't chronic (which is why so few pharam companies bothers to develop new antibiotics, despite the huge need -- they simply can't cover the development expenses on medicine tha actually quickly heal their patients and will only be used as a last-resort approach when all conventonal antibiotics have failed). Anyway, these high costs of development is the reason why pharma companies have margins above 90 % on their drugs. They need to cover these 1500 million in costs, finance future expensive drug developments, and have a profit in the end.

When copy drugs hit the market we know from small molecule copy drugs (= generics) that the competition will lower the prices by 30-70 %. So they have a fairly short time to recuperate their losses and make their profit. A cheaper regulatory process, more evidence-based, and smarter, could reduce the costs of developing new drugs substantially, with only insiginificant changes to the risk profile of a new drug. This would mean pharma could reduce margins, and hence the exit-price of the drugs, and still, when all the prior costs are accounted for, end up with the same profit. The existing drugs could not onæy become accessible to larger groups of patients, but pharma could also afford to develop drugs for neglected diseases.

But also the developer of copy drugs faces expensive development, not only the originatorm especially so for large molecule copy drugs (=biosimilars) that due to their complexity requires much more pre-clinical data in their approval process. They typically don't need to demonstrate the same efficacy and safety profile as the originator drug, but instead focus on proving bioequivalence (that the copy and the proginator is the same (mix of) chemical compunds), yet the average costs of developing a biosimilar drug is still 500-750 million (!). Okay, you might think, that is only half of what the originator drug costs, what is the problem? The problem is that when they launch their biosmilar, they have a strong, established competitor in the market they have to compete with. They don't have an open market and with exclusivity so they can set the margins more or less where they want them. They have had less costs in development, but will probably have much less revenues due to fierce competition. So they can't lower the prices to the same extent as generics have been doing this last decades, and hence we don't expect to see the same cut throat pricing competition leading to the same large reductions in drug exit-prices. Bt there will still be some, as we see for insulin biosimilars.

I am all for a regulatory overhaul in the drugs market, because there is no industry that could not benefit from doing things better, but I simply feel that any changes which serve to lower the current safety protocols are potentially dangerous and that the area is industry is large enough that positive changes can be affected in other areas.

You're Norwegian, correct? How do the regulatory bodies do things in Norway, in regards to testing protocols and the amount of time and money it takes to bring a drug to market? The reason that I ask is that Norway is a small country, but is also socially minded and forward thinking; I would assume that things are more relaxed in Norway? Obviously we have to take into account the fact that Norway has socialised medicine (a good thing), so the government is always there to pick up the tab, but I would assume that Norway has far less paperwork than the USA does and therefore drugs can come to market at a lower price and in quicker time.

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1 minute ago, PappyTron said:

I am all for a regulatory overhaul in the drugs market, because there is no industry that could not benefit from doing things better, but I simply feel that any changes which serve to lower the current safety protocols are potentially dangerous and that the area is industry is large enough that positive changes can be affected in other areas.

You're Norwegian, correct? How do the regulatory bodies do things in Norway, in regards to testing protocols and the amount of time and money it takes to bring a drug to market? The reason that I ask is that Norway is a small country, but is also socially minded and forward thinking; I would assume that things are more relaxed in Norway? Obviously we have to take into account the fact that Norway has socialised medicine (a good thing), so the government is always there to pick up the tab, but I would assume that Norway has far less paperwork than the USA does and therefore drugs can come to market at a lower price and in quicker time.

Oh, don't get me wrong, I agree completely that there is much that could be done in other areas to fix problems with this industry, and looking at simplifying regulatory pathways is probably not on top of that list.

Yes, I am Norwegian. As far as I know, no drugs are developed in Norway. But even if they were then Norway has decided, through its European Economic Area membership, to implement EMA's guidelines on this, so you wouldn't be able to get around strict guidelines elsewhere by developing your drug in Norway. And even if you were, you would still only be allowed to market that drug in Norway, as soon as you tried elsewhere you would have to do provide any extra documentation as per that jurisdiction's guidelines.

This brings to mind another thing that makes drug development so costly. You have to adhere to multiple guidelines for different regions (FDA, EMA, Japan, etc) if you want to market that drug in these regions. And just understanding what is required is in itself so complicated it allows for a thriving industry of well-paid consultants and advisors that help pharmaceutical companies navigate the jungle of often vague rules and requirements.

It's a mess.

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5 minutes ago, SoulMonster said:

Oh, don't get me wrong, I agree completely that there is much that could be done in other areas to fix problems with this industry, and looking at simplifying regulatory pathways is probably not on top of that list.

Yes, I am Norwegian. As far as I know, no drugs are developed in Norway. But even if they were then Norway has decided, through its European Economic Area membership, to implement EMA's guidelines on this, so you wouldn't be able to get around strict guidelines elsewhere by developing your drug in Norway. And even if you were, you would still only be allowed to market that drug in Norway, as soon as you tried elsewhere you would have to do provide any extra documentation as per that jurisdiction's guidelines.

This brings to mind another thing that makes drug development so costly. You have to adhere to multiple guidelines for different regions (FDA, EMA, Japan, etc) if you want to market that drug in these regions. And just understanding what is required is in itself so complicated it allows for a thriving industry of well-paid consultants and advisors that help pharmaceutical companies navigate the jungle of often vague rules and requirements.

It's a mess.

Do the bulk of the testing results carry over from region to region? That is to say, if a drug is passed by the FDA does it get a head start when the company wants to introduce it to Europe, or do the EMA simply say "That drug is new to us, as far as we are concerned, so you have to test it from the beginning"?

Following on from what I touched on in the last post, but Norway has a completely socialised healthcare service, correct? If you fall over tomorrow and break your arm you simply go to the hospital to be patched up, no cost incurred? Here in the UK you don't even need to be a citizen of the country; you could come to London and have an accident and they will take care of you 100%, though I am assuming that that holds true in Norway as well. One of the major expenses of the UK's health service is the fact that they tend to purchase their medicine from private supply houses which massively increase the selling price. So, I can walk to the chemist and buy some antibiotics for, let's say £1.00 a tablet, yet the NHS will buy the same tablet for £3.50.

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2 minutes ago, PappyTron said:

Do the bulk of the testing results carry over from region to region? That is to say, if a drug is passed by the FDA does it get a head start when the company wants to introduce it to Europe, or do the EMA simply say "That drug is new to us, as far as we are concerned, so you have to test it from the beginning"?

Following on from what I touched on in the last post, but Norway has a completely socialised healthcare service, correct? If you fall over tomorrow and break your arm you simply go to the hospital to be patched up, no cost incurred? Here in the UK you don't even need to be a citizen of the country; you could come to London and have an accident and they will take care of you 100%, though I am assuming that that holds true in Norway as well. One of the major expenses of the UK's health service is the fact that they tend to purchase their medicine from private supply houses which massively increase the selling price. So, I can walk to the chemist and buy some antibiotics for, let's say £1.00 a tablet, yet the NHS will buy the same tablet for £3.50.

Yes, the bulk can be carried over, IF they comply with each regulatory body's clinical-trial legislation. To some extent FDA and EMA (and other regulatory bodies) are harmonized and this is set out in the joint ICH guidelines which, among other, defines what is considered Good Clinical Practice by all parties; but they to differ in certain ways, so to make sure that data can be carried over, you have to take care when designing the clinical trials, both in terms of where and how they are done. And in some cases you simply have to to certain clinical trials twice to adhere to conflicting guidelines. Eventually, though, it is hoped and assumed FDA and EMA will merge their guidelines, but this is some time in the future.

In Norway healthcare is free for anyone under 16 or who is pregnant. Adults have to pay a little bit themselves when they need healthcare, but when they have done that they get free healthcare for the rest of the year. An exception is immediate healthcare, like if you have to go to the emergency room, which is free for everyone regardless of age. The Norwegian goverment negotiates with pharma for prices on drugs. In some cases we say no and some drugs, especially cancer drugs for alleviating care, are not accessible to Norwegians through the healthcare system because we couldn't agree on a price. So even in the country with the highest healthcare expenditure per capita, some drugs are deemed too expensive.

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2 hours ago, SoulMonster said:

Yes, the bulk can be carried over, IF they comply with each regulatory body's clinical-trial legislation. To some extent FDA and EMA (and other regulatory bodies) are harmonized and this is set out in the joint ICH guidelines which, among other, defines what is considered Good Clinical Practice by all parties; but they to differ in certain ways, so to make sure that data can be carried over, you have to take care when designing the clinical trials, both in terms of where and how they are done. And in some cases you simply have to to certain clinical trials twice to adhere to conflicting guidelines. Eventually, though, it is hoped and assumed FDA and EMA will merge their guidelines, but this is some time in the future.

In Norway healthcare is free for anyone under 16 or who is pregnant. Adults have to pay a little bit themselves when they need healthcare, but when they have done that they get free healthcare for the rest of the year. An exception is immediate healthcare, like if you have to go to the emergency room, which is free for everyone regardless of age. The Norwegian goverment negotiates with pharma for prices on drugs. In some cases we say no and some drugs, especially cancer drugs for alleviating care, are not accessible to Norwegians through the healthcare system because we couldn't agree on a price. So even in the country with the highest healthcare expenditure per capita, some drugs are deemed too expensive.

What is your opinion on a government getting involved in the drugs business directly, and treating it just the same as another branch of government such as transport or education?

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1 hour ago, Amir said:

What is interesting is that he is on bail on a $5 million bond which was secured against his stock account which has fallen from $45 to under $4 million. In other words, his net worth has plummeted so far in the last few weeks that his liquid assets don't even cover his posted bond.

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8 hours ago, PappyTron said:

What is your opinion on a government getting involved in the drugs business directly, and treating it just the same as another branch of government such as transport or education?

On the face of it it sounds like a brilliant idea, but I haven't given it much thought. To some extent we already allow governmental institutions and the like (WHO among others) to facilitate research and development of drugs where pharmaceutical companies would take too long or be too expensive.

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Years of research and trials are nessecary to prove the effectiveness of medications. However generic equivalents are not required the same trials but must prove they are of the same formula. In some cases our bodies don't break down the compounds.

 

There is some belief that money is the incentive for medical breakthroughs, not just for the common good. The polio vaccine and pennicillin was never patent by their inventors because they wanted them cheap and available. There's more incentive to treat long term illnesses because that means more money for the drug companies. HIV meds are espensive, finding a cure would eventually cost them.

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