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Shkreli, Drug Price Gouger, Denies Fraud and Posts Bail


SoulMonster

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Just now, PappyTron said:

Which is the way that I would suggest it be done in the US. However, I'm not convinced that a Goverment should have a moral obligation to those who effectively put themselves in a position of needing help. Should the government pay for a person to have a double lung transplant after a lifetime of heavy smoking? Some would say that their taxes paid for it.

I'm not going to lie, it does bother me seeing some 500 pound behemoth in a motorized scooter paying for their chips, pop, and other junk food instead of fruit and vegetables at a grocery store knowing that their poor choices will require medical care paid for by other tax payers.  So I see what you're saying.  We pay for cancer treatment in Canada regardless of whether you've never smoked a day in your life or every day for however many years.  It seems unfair but I'm not sure there's any way around it save for de-regulation and/or privatization.  

Constitutionally, the Commerce Clause would allow the U.S. federal government to regulate drug prices should laws ever be changed.  While less common now (with exception of rent control), price controls have been employed many times in U.S. history.  

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7 minutes ago, downzy said:

I'm not going to lie, it does bother me seeing some 500 pound behemoth in a motorized scooter paying for their chips, pop, and other junk food instead of fruit and vegetables at a grocery store knowing that their poor choices will require medical care paid for by other tax payers.  So I see what you're saying.  We pay for cancer treatment in Canada regardless of whether you've never smoked a day in your life or every day for however many years.  It seems unfair but I'm not sure there's any way around it save for de-regulation and/or privatization.  

Constitutionally, the Commerce Clause would allow the U.S. federal government to regulate drug prices should laws ever be changed.  While less common now (with exception of rent control), price controls have been employed many times in U.S. history.  

I would say, with general broad strokes, I believe that nobody should be cast adrift by either society or by the government in general; however, I'm all for personal responsibility being the core of society. How we get those two things to line up with each other is the trick, obviously, as is the balance between capitalism and the pursuit of business and the protection of a nation's citizens from modern day robber barons. WalMart would be a good example; I am all for them pursuing the market and cornering any area that they enter into, but I am fully against their practice of having zero hour contracts, or employing staff for less than the minimum hours where WalMart have to pay state insurance, and am strongly against them being subsidised, in any field or in any capacity, by the state or Federal government.

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3 minutes ago, PappyTron said:

I would say, with general broad strokes, I believe that nobody should be cast adrift by either society or by the government in general; however, I'm all for personal responsibility being the core of society. How we get those two things to line up with each other is the trick, obviously, as is the balance between capitalism and the pursuit of business and the protection of a nation's citizens from modern day robber barons. WalMart would be a good example; I am all for them pursuing the market and cornering any area that they enter into, but I am fully against their practice of having zero hour contracts, or employing staff for less than the minimum hours where WalMart have to pay state insurance, and am strongly against them being subsidised, in any field or in any capacity, by the state or Federal government.

So where do you land on the minimum wage?  Many have argued that the low minimum wage in the U.S. is a form of corporate welfare for companies like Walmart, as their under-paid employees are then forced to use government subsidies and services (food stamps, medicaid, disability insurance) for survival.  

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2 minutes ago, downzy said:

So where do you land on the minimum wage?  Many have argued that the low minimum wage in the U.S. is a form of corporate welfare for companies like Walmart, as their under-paid employees are then forced to use government subsidies and services (food stamps, medicaid, disability insurance) for survival.  

I think that minimum wage is a good thing, but needs a balance on the other end of the lever, because a lot of companies (such as WalMart) will use it to exploit workers in another way. "Oh, we don't need you for 40 hours, just 20". So, for that person being paid 50% more per hour has done them no favours because they are taking home less when all is said and done. Obviously a minimum wage needs to be relative to the cost of the society around it, but we also need to be realistic and accept that some jobs, even if tedious and boring, require next to no skills and should be paid accordingly. My big issue with companies such as WalMart and minimum wage is that they use it as an excuse to push the workers onto government benefits by ensuring that they don't quite make the cutoff point.

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13 minutes ago, downzy said:

So where do you land on the minimum wage?  Many have argued that the low minimum wage in the U.S. is a form of corporate welfare for companies like Walmart, as their under-paid employees are then forced to use government subsidies and services (food stamps, medicaid, disability insurance) for survival.  

The very same reason I argue against Bernie's stance on minimum wage is relevant here. States, and even cities, are completely free to set their own minimum wage. Seattle and LA have done the $15 an hour thing, because it's expensive to live there. The federal minimum wage should be the lowest, and states and cities can raise it if they need to. Minimum wage is not to live a comfortable life, it's to live, with the minimum. Not to raise a family, not to pay for your new flatscreen. Rent for a place to live, which is held to certain standards, food to eat. If you can't afford food, there are food stamps, there is medicaid. But a blanket minimum wage that is higher than necessary in certain parts of the country is just wrong, you think that guy making $16 an hour is gonna get a bump in pay? Nope, sorry, you make just above minimum wage now. Where I live, I initially got approved to buy my house on 15 an hour.

 

Move this to the political thread if need be, I kind of got on a rant.

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8 hours ago, downzy said:

I can't speak for other developed countries (FYI, of all the OECD countries, only Chile and the U.S. do not control drug prices), but here in Canada, it works fairly well.  We have something called the Patented Medicine Prices Review Board that determines the maximum price a patented drug that has no generic substitutes can sell in Canada.  If drug companies don't like it, well, Canadians do not get the drugs.  While I'm sure there are some examples, I'm unaware of any drugs that are sold in the U.S. but not sold in Canada (and in most cases, Canadians pay substantially far less for the same drugs).  

Similar system in Norway, and some drugs are so expensive we just won't buy them. It's atrocious.

As for a cap on prices. Yes, there should be some cap on the price of originator drugs. A pharmaceutical company with monopoly on a drug shouldn't be allowed to set whatever price they want. Sick people will pay ANYTHING for medicine, especially if it is life-saving. So to prevent pharma companies exploiting this by raising the price as high as possible, there should be some cap that would ensure that they get only good margins (enough to compensate for the costs they have had, and some). Exactly what that cap will be I don't know, and I have no problems with pharma earning money and people getting rich. The important thing is not to cut their earnings but to fix a system where large porportions of patients (both in poor countries but also in rich countries) don't have access to necessary medicine because of prohibitive high prices.

But more importantly than a cap on exit-prices, there should be quicker regulatory pathways for non-originator drugs (generics and biosmilars) so that these may come to market earlier to create compettion and lower the prices. The way it is now, getting a non-originator to market takes too long (so that the originator can rule the market alone with their high prices) and costs too much because of obligatory clinical trials and similarity demands (so that the price of the replica isn't as low as it should be). This means the originator can rule the market alone beyond its patent protection, and when it gets competition from copy medicine, that competition isn't as harsh as it should be.

Lastly, the costs of developing drugs must be reduced so that the exit-price of drugs can be lowered without this meaning a cut in the companies' margins. Developing a drug costs WAY too much today. There are many reasons for this, including regulatory pathways and costs of clinical trials, but also inefficient R&D in pharma, the structure of M&As, inefficient tech transfer from Academia, etc. A lot can be done to reduce these costs.

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59 minutes ago, SoulMonster said:

Similar system in Norway, and some drugs are so expensive we just won't buy them. It's atrocious.

As for a cap on prices. Yes, there should be some cap on the price of originator drugs. A pharmaceutical company with monopoly on a drug shouldn't be allowed to set whatever price they want. Sick people will pay ANYTHING for medicine, especially if it is life-saving. So to prevent pharma companies exploiting this by raising the price as high as possible, there should be some cap that would ensure that they get only good margins (enough to compensate for the costs they have had, and some). Exactly what that cap will be I don't know, and I have no problems with pharma earning money and people getting rich. The important thing is not to cut their earnings but to fix a system where large porportions of patients (both in poor countries but also in rich countries) don't have access to necessary medicine because of prohibitive high prices.

But more importantly than a cap on exit-prices, there should be quicker regulatory pathways for non-originator drugs (generics and biosmilars) so that these may come to market earlier to create compettion and lower the prices. The way it is now, getting a non-originator to market takes too long (so that the originator can rule the market alone with their high prices) and costs too much because of obligatory clinical trials and similarity demands (so that the price of the replica isn't as low as it should be). This means the originator can rule the market alone beyond its patent protection, and when it gets competition from copy medicine, that competition isn't as harsh as it should be.

Lastly, the costs of developing drugs must be reduced so that the exit-price of drugs can be lowered without this meaning a cut in the companies' margins. Developing a drug costs WAY too much today. There are many reasons for this, including regulatory pathways and costs of clinical trials, but also inefficient R&D in pharma, the structure of M&As, inefficient tech transfer from Academia, etc. A lot can be done to reduce these costs.

Do you not feel that if a company has spent Billions of Pounds/Euros/Dollars researching a drug and perhaps a decade of time, that they deserve the fruit of their endeavors? Most drugs patents last for 20 years, but that includes the time it takes to get FDA approval after clinical trials etc. The last thing we want is to cut corners when it comes to the voracity of the testing protocols. What I'd like to see is a better balance between generic manufacturers and originator companies because as it stands they both try and "win" by suing the other which either lengthens or shortens the available time the other company has to utilise the drugs.

What I find interesting is the close relationship that some drugs companies have with universities; Yale, for example, does a LOT of work with Pfizer, to the tune of millions of Dollars a year (the money goes both ways). Yale have their own hospital, transplant center, biomedical research division, and they do clinical trials worth millions of Dollars every year.

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34 minutes ago, PappyTron said:

Do you not feel that if a company has spent Billions of Pounds/Euros/Dollars researching a drug and perhaps a decade of time, that they deserve the fruit of their endeavors? Most drugs patents last for 20 years, but that includes the time it takes to get FDA approval after clinical trials etc. The last thing we want is to cut corners when it comes to the voracity of the testing protocols. What I'd like to see is a better balance between generic manufacturers and originator companies because as it stands they both try and "win" by suing the other which either lengthens or shortens the available time the other company has to utilise the drugs.

What I find interesting is the close relationship that some drugs companies have with universities; Yale, for example, does a LOT of work with Pfizer, to the tune of millions of Dollars a year (the money goes both ways). Yale have their own hospital, transplant center, biomedical research division, and they do clinical trials worth millions of Dollars every year.

I didn't say they shouldn't earn money. There could easily be a cap on prices and big pharma would still earn money. Trust me, they have pretty substantial margins as it is :) I am not against capitalism, and think it is great that one can earn lots of money from selling producs others desire. But there is a difference between the owners of Tesla becoming filthy rich from selling cars and the owners of Pfizer becoming filthy rich from selling life-saving drugs. Everybody can't afford a Tesla, and that is fine, they can have a cheaper car or maybe get by without one altogether. But everybody can't find a cheaper cancer drug, or "get by" with advanced stage cancer or other forms of terminal cancer. There simply is a differece between these things and in this specific and rare case I believe governments should enforce caps that would open up access to certain medicines and STILL allow pharma to earn nice money.

I disagree with your opinion that "the last thing we want is to cut corners when it comes to the voracity of the testing protocols". If we could reduce the requirements for some clinical trials then drug development would become less expensive, and pharma could lower prices without losing revenues resulting in drugs becoming accessible to more patients. There is a balance here between approving something for market which could potentially be ineffective or dangerous, and having so expensive approval process that the costs of drugs becoming prohibitive to many patients. What would we be best off with? I believe that by skewing the balance slightly in favor of quicker (and less expensive regulatory pathways) the net effect would be more patients treated due to lower prices and quicker market access (although we would have slightly more cases of drugs being taken off market because it would turn out that post-approval their efficacy wasn't so great).

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3 minutes ago, SoulMonster said:

I didn't say they shouldn't earn money. There could easily be a cap on prices and big pharma would still earn money. Trust me, they have pretty substantial margins as it is :) I am not against capitalism, and think it is great that one can earn lots of money from selling producs others desire. But there is a difference between the owners of Tesla becoming filthy rich from selling cars and the owners of Pfizer becoming filthy rich from selling life-saving drugs. Everybody can't afford a Tesla, and that is fine, they can have a cheaper car or maybe get by without one altogether. But everybody can't find a cheaper cancer drug, or "get by" with advanced stage cancer or other forms of terminal cancer. There simply is a differece between these things and in this specific and rare case I believe governments should enforce caps that would open up access to certain medicines and STILL allow pharma to earn nice money.

I disagree with your opinion that "the last thing we want is to cut corners when it comes to the voracity of the testing protocols". If we could reduce the requirements for some clinical trials then drug development would become less expensive, and pharma could lower prices without losing revenues resulting in drugs becoming accessible to more patients. There is a balance here between approving something for market which could potentially be ineffective or dangerous, and having so expensive approval process that the costs of drugs becoming prohibitive to many patients. What would we be best off with? I believe that by skewing the balance slightly in favor of quicker (and less expensive regulatory pathways) the net effect would be more patients treated due to lower prices and quicker market access (although we would have slightly more cases of drugs being taken off market because it would turn out that post-approval their efficacy wasn't so great).

If a government is concerned about the well-being of its citizens it could always get involved in the pharmaceutical business directly. In fact, it would probably be beneficial if a government was the direct supplier of given drugs; anything that cuts out the middleman is always cheaper.

I'm surprised that you want to reduce the requirements for clinical trials, given that the purpose of clinical trials is to ensure not just the effectiveness of the drug, but also the safety of it. Your last sentence is actually quite worrying; the last thing you want is for drugs to have to be taken off market because after time in the market they are proved to either be inefficient, or possibly dangerous. So, let's say that Pfizer develop a diabetes drug and rather than the 8 years it currently takes to get to market they follow your plan and it takes 4. However, after 2 years it is shown to not only be not as effective as first hoped, but also to have dangerous side effects up to and including death. We now have millions of people, potentially, who are using this drug daily, and who knows how many dead or with side-effects because of it. What is the recourse for that situation? Even as it stands drugs have to be pulled from the market because of unforeseen problems with them; reducing the testing process would make this far worse, and would be hugely detrimental to those who need the drugs.

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5 minutes ago, PappyTron said:

If a government is concerned about the well-being of its citizens it could always get involved in the pharmaceutical business directly. In fact, it would probably be beneficial if a government was the direct supplier of given drugs; anything that cuts out the middleman is always cheaper.

I'm surprised that you want to reduce the requirements for clinical trials, given that the purpose of clinical trials is to ensure not just the effectiveness of the drug, but also the safety of it. Your last sentence is actually quite worrying; the last thing you want is for drugs to have to be taken off market because after time in the market they are proved to either be inefficient, or possibly dangerous. So, let's say that Pfizer develop a diabetes drug and rather than the 8 years it currently takes to get to market they follow your plan and it takes 4. However, after 2 years it is shown to not only be not as effective as first hoped, but also to have dangerous side effects up to and including death. We now have millions of people, potentially, who are using this drug daily, and who knows how many dead or with side-effects because of it. What is the recourse for that situation? Even as it stands drugs have to be pulled from the market because of unforeseen problems with them; reducing the testing process would make this far worse, and would be hugely detrimental to those who need the drugs.

Goverrment shoud be more involved. The safety of its citizens is to important to be put into the hands of companies. That is why governments ARE involved to diffeernt degrees around the world. E.g. Norway has a system for getting biosimilars to market much more afforably than its originator drugs.

What you need to understand is that the approval system already today is a cut-off between making sure that the drug is safe, and that the drug actually enters the market. In theory you can never be 100 % certain the drug is safe for every patient, so we have decided to ONLY test each drug for X no of patients in such and such ways. I am not saying that we shouldn't test drugs, just that we shoudl reduce the amount of trials experiments for some drugs, and be a little smarter about what trials must be passed (i.e. the extent of physicochemical tests to be done with biosimilars is ridiculous!). This would ensure that, say, twice as many patients can get access to a drug globally, but with only slight increase in risk of that drug not being exactly as efficious as expected or with only a slight increase in probablity of side-effects.

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17 minutes ago, SoulMonster said:

Goverrment shoud be more involved. The safety of its citizens is to important to be put into the hands of companies. That is why governments ARE involved to diffeernt degrees around the world. E.g. Norway has a system for getting biosimilars to market much more afforably than its originator drugs.

What you need to understand is that the approval system already today is a cut-off between making sure that the drug is safe, and that the drug actually enters the market. In theory you can never be 100 % certain the drug is safe for every patient, so we have decided to ONLY test each drug for X no of patients in such and such ways. I am not saying that we shouldn't test drugs, just that we shoudl reduce the amount of trials experiments for some drugs, and be a little smarter about what trials must be passed (i.e. the extent of physicochemical tests to be done with biosimilars is ridiculous!). This would ensure that, say, twice as many patients can get access to a drug globally, but with only slight increase in risk of that drug not being exactly as efficious as expected or with only a slight increase in probablity of side-effects.

I'm aware that there is a balance between safety and the ability for the drug to enter the market. However, I don't agree that there should be trade off where the net result is effectively "We can reach twice as many people, but 20% of the people may not get the correct treatment, or may experience extreme side effects up to and including death because it turns out that the drugs were not tested correctly either for efficacy or suitability". Now, for drugs that are generic copies of previously patented drugs I do agree that there should be less red tape because they are, after all, chemical copies and any company with a chemical lab and staff are able to make exact chemical twins of a given drug, and if they can't then they shouldn't be in business.

 

 

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11 minutes ago, PappyTron said:

I'm aware that there is a balance between safety and the ability for the drug to enter the market. However, I don't agree that there should be trade off where the net result is effectively "We can reach twice as many people, but 20% of the people may not get the correct treatment, or may experience extreme side effects up to and including death because it turns out that the drugs were not tested correctly either for efficacy or suitability". Now, for drugs that are generic copies of previously patented drugs I do agree that there should be less red tape because they are, after all, chemical copies and any company with a chemical lab and staff are able to make exact chemical twins of a given drug, and if they can't then they shouldn't be in business.

There already IS a trade off. FDA and EMA has decided where that trade off should be. I am suggesting it is skewed slightly in favor of quicker development times so that we can reduce the prices and treat more people, even if there is a slight increase in an approved drug not beign equally efficaous. Your example of 20 % is not something I too would accept, but it is a gross exaggeration. In my opinion we are looking at drugs that could potentially treat 5 million more patients globally with only very slight probabilities of the drug being less efficaous (not being inert, just less efficaous) or having an increased adverse side-effect profile. I am also not saying that the requiremnets should be less rigid for all drugs, just that the regulatory bodies should be smarter in terms of what they require of clinical trials and documentation for specific drugs. E.g., should REALLY an insulin biobetter with only one amino acid substitution need the FULL clinical trial requirements as if it was a NBA (new biological entity), or could such biobetter drugs rather be approved through the now established biosimilar fast-track program 501(k)? In my opinion we would be WAY better off if we allowed this.

I wasn't talking so much about generics (small-molecule copies) as biosmilars (biologics copies; large-molecule copies) where 501(k) approval exists now but where there is still a too high demand on both clinical trials (despite the FDA voiced requirement to only show bioequvalence (aka similarity) and not drug efficacy!) and physicochemical tests to demonstate that the originator and the biosimilar are biologically equivalent.

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Just now, SoulMonster said:

Wrong type of drugs, I guess...

Still...

 

$13.00 a pill to $750 overnight?

 

Srsly, what happened? Did one of my enemies or friends discover time travel, go back in time, created this alternate timeline and did that...

WHO IS THAT GUY? Worse thing I saw was him acting like typical ass hole just being.

Damn... He's out of nowhere and acts... Like someone probably went back, from my social circles, and changed a bunch of a crap, and now we have him. :lol:

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Can i give you a little life tip Snakes?  When something new is presented to you, that you're not privy to the details of, look it up if your interested, or just perhaps observe the discourse and get some sort of a grasp on the subject...then give your opinion.  Saying this cuz i love you :lol:

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18 hours ago, Silent Jay said:

I like Shkeli. He's a bit cocky but with success that is unavoidable. What they don't report and won't is insurance companies pay the increase, not the end user (only 1 to 10$). Actually, Shkreli's company is the only one that gives away medecine to the uninsured.

 

 

 

Uhm.....you do realize that eventually, higher cost medicine would increase the premiums people pay for insurance, right?

 

 

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On 2/6/2016 at 2:09 PM, Len B'stard said:

Can i give you a little life tip Snakes?  When something new is presented to you, that you're not privy to the details of, look it up if your interested, or just perhaps observe the discourse and get some sort of a grasp on the subject...then give your opinion.  Saying this cuz i love you :lol:

7NT3iJa.gif

Normally, I'd agree with you Len - you're usually pretty smart when it comes to this type of thing; but this is clearly a case of time travel into the past, for some reason - I seem to be immune to some of the effects of this, but; I don't know if I can fix things to 'how it was'.. The bastard may have just gotten away with it.

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9 hours ago, SoulMonster said:

There already IS a trade off. FDA and EMA has decided where that trade off should be. I am suggesting it is skewed slightly in favor of quicker development times so that we can reduce the prices and treat more people, even if there is a slight increase in an approved drug not beign equally efficaous. Your example of 20 % is not something I too would accept, but it is a gross exaggeration. In my opinion we are looking at drugs that could potentially treat 5 million more patients globally with only very slight probabilities of the drug being less efficaous (not being inert, just less efficaous) or having an increased adverse side-effect profile. I am also not saying that the requiremnets should be less rigid for all drugs, just that the regulatory bodies should be smarter in terms of what they require of clinical trials and documentation for specific drugs. E.g., should REALLY an insulin biobetter with only one amino acid substitution need the FULL clinical trial requirements as if it was a NBA (new biological entity), or could such biobetter drugs rather be approved through the now established biosimilar fast-track program 501(k)? In my opinion we would be WAY better off if we allowed this.

I wasn't talking so much about generics (small-molecule copies) as biosmilars (biologics copies; large-molecule copies) where 501(k) approval exists now but where there is still a too high demand on both clinical trials (despite the FDA voiced requirement to only show bioequvalence (aka similarity) and not drug efficacy!) and physicochemical tests to demonstate that the originator and the biosimilar are biologically equivalent.

You are happy to release a drug to market that has a potentially increased "adverse side-effect profile", with those potential side-effects including anything up to and death. I'm not sure whether that is a road that the market would want to take. Of course there is already a balance, as without one nothing would ever get to market, but I think that a better area of attack, rather than cutting the testing process, would be to work on reducing the litigation between drugs originators and those companies which seek to reproduce them. My doctorate is not in biochemistry, nor do I work in the industry, so I am neither that familiar with the industry or the field of chemistry as a whole, but if a derivative comes to market then it should have the same end testing as an originator drug; if that testing only needs to be around whatever chemical properties have been changed, or have the potential to have an effect on the end user, then so be it.

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7 hours ago, Snake-Pit said:

srsly though, who the Hell is this guy people are 'so readily to have heard of'?

He's got the only copy of Wu-Tang's 'Once Upon A Shaolin' and he's using it as a drink coaster :facepalm:

Replace 'Wu-Tang's Once Upon A Shaolin' with CD II and you catch my drift :lol:

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2 hours ago, Bumblefeet said:

He's got the only copy of Wu-Tang's 'Once Upon A Shaolin' and he's using it as a drink coaster :facepalm:

Replace 'Wu-Tang's Once Upon A Shaolin' with CD II and you catch my drift :lol:

Could you imagine the utter rage and venom expressed here at this forum if Axl had sold CD II to a guy like Shkreli?

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10 hours ago, PappyTron said:

You are happy to release a drug to market that has a potentially increased "adverse side-effect profile", with those potential side-effects including anything up to and death.

I am not happy to release such a drug. Why would I want that? But I would be happy to release a drug to market for which I could half the price leading to 10-fold more patients surviving a disease, 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 for a small minority of patients.

You are questioning whether the market would want it. Yes, a terminally ill patient in Angola would EMBRACE the chance to get access to a drug for which he (or his nation) otherwise could not afford even if it meant there was a small chance that he could be in the subgroup for which it wouldn't be effective, or even have an adverse side-effect. The alternative is DEATH. The worst-case scenario is death with an adverse side-effect. I think he, and anyone else, would jump at such an opportunity.

You suggest that it would be better to work on "reducing the litigation between drugs originators and those companies which seek to reproduce them". I don't see this as much of a problem, at least not to rival excessive drug costs as a problem. The main barrier to generics/biosimilars isn't litigation from originators, but market acceptance (patients and doctors not trusting copy medicine) and regulatory hurdles (incessant requirements that means development of replica medicine costs much more than needed). I spent Monday and Tuesday this week at a conference in Berlin discussing exactly WHY biosimilars only now start to enter the markets, and litigation never came up. Sure, this is an area of industry with plenty of legal disputes but this is not considered a particular problem for copy medicines and their market penetration.

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1 hour ago, SoulMonster said:

I am not happy to release such a drug. Why would I want that? But I would be happy to release a drug to market for which I could half the price leading to 10-fold more patients surviving a disease, 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 for a small minority of patients.

You are questioning whether the market would want it. Yes, a terminally ill patient in Angola would EMBRACE the chance to get access to a drug for which he (or his nation) otherwise could not afford even if it meant there was a small chance that he could be in the subgroup for which it wouldn't be effective, or even have an adverse side-effect. The alternative is DEATH. The worst-case scenario is death with an adverse side-effect. I think he, and anyone else, would jump at such an opportunity.

You suggest that it would be better to work on "reducing the litigation between drugs originators and those companies which seek to reproduce them". I don't see this as much of a problem, at least not to rival excessive drug costs as a problem. The main barrier to generics/biosimilars isn't litigation from originators, but market acceptance (patients and doctors not trusting copy medicine) and regulatory hurdles (incessant requirements that means development of replica medicine costs much more than needed). I spent Monday and Tuesday this week at a conference in Berlin discussing exactly WHY biosimilars only now start to enter the markets, and litigation never came up. Sure, this is an area of industry with plenty of legal disputes but this is not considered a particular problem for copy medicines and their market penetration.

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.

 

Edited by PappyTron
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