High probability that most Oncology drugs based on flawed research

Anonymous

Guest
Feeling good about selling or working for a company that develops and sells Oncology drugs? That is what many in pharma say that they feel when confronted by the fact that the FDA publicly publishes the fact that licensed generics are equivalent to the branded drugs that they compete with and numerous peer reviewed scientific studies by the largest and most influential clinical professional organizations in the world have shown that over 80% of the branded drugs docs write scripts for can be replaced by those same generics.

So what happens when the basis for the efficacy of the research for the justification of those drugs is undermined by a peer reviewed study published in one of the world's most influential scientific journals?


"Nature

Drug development: Raise standards for preclinical cancer research

The scientific community assumes that the claims in a preclinical study can be taken at face value — that although there might be some errors in detail, the main message of the paper can be relied on and the data will, for the most part, stand the test of time. Unfortunately, this is not always the case. Although the issue of irreproducible data has been discussed between scientists for decades, it has recently received greater attention (see go.nature.com/q7i2up) as the costs of drug development have increased along with the number of late-stage clinical-trial failures and the demand for more effective therapies.

Over the past decade, before pursuing a particular line of research, scientists (including C.G.B.) in the haematology and oncology department at the biotechnology firm Amgen in Thousand Oaks, California, tried to confirm published findings related to that work. Fifty-three papers were deemed 'landmark' studies (see 'Reproducibility of research findings'). It was acknowledged from the outset that some of the data might not hold up, because papers were deliberately selected that described something completely new, such as fresh approaches to targeting cancers or alternative clinical uses for existing therapeutics. Nevertheless, scientific findings were confirmed in only 6 (11%) cases. Even knowing the limitations of preclinical research, this was a shocking result."

http://www.nature.com/nature/journal/v483/n7391/full/483531a.html
 

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Feeling good about selling or working for a company that develops and sells Oncology drugs? That is what many in pharma say that they feel when confronted by the fact that the FDA publicly publishes the fact that licensed generics are equivalent to the branded drugs that they compete with and numerous peer reviewed scientific studies by the largest and most influential clinical professional organizations in the world have shown that over 80% of the branded drugs docs write scripts for can be replaced by those same generics.

So what happens when the basis for the efficacy of the research for the justification of those drugs is undermined by a peer reviewed study published in one of the world's most influential scientific journals?


"Nature

Drug development: Raise standards for preclinical cancer research

The scientific community assumes that the claims in a preclinical study can be taken at face value — that although there might be some errors in detail, the main message of the paper can be relied on and the data will, for the most part, stand the test of time. Unfortunately, this is not always the case. Although the issue of irreproducible data has been discussed between scientists for decades, it has recently received greater attention (see go.nature.com/q7i2up) as the costs of drug development have increased along with the number of late-stage clinical-trial failures and the demand for more effective therapies.

Over the past decade, before pursuing a particular line of research, scientists (including C.G.B.) in the haematology and oncology department at the biotechnology firm Amgen in Thousand Oaks, California, tried to confirm published findings related to that work. Fifty-three papers were deemed 'landmark' studies (see 'Reproducibility of research findings'). It was acknowledged from the outset that some of the data might not hold up, because papers were deliberately selected that described something completely new, such as fresh approaches to targeting cancers or alternative clinical uses for existing therapeutics. Nevertheless, scientific findings were confirmed in only 6 (11%) cases. Even knowing the limitations of preclinical research, this was a shocking result."

http://www.nature.com/nature/journal/v483/n7391/full/483531a.html

Not necessarily "flawed research" at all !!!
Incomplete and bullied research more likely.
Just too much eagerness to get things done quickly, please the management, the shareholders, massage own ego etc.
Of course, then there is simple greed, arrogance and ineptness amongst the "Leadership" (ouch)...so that doesn't help at all.
Any technical person (a vanishing breed) who objects or presents alternative opinions to the mission statement is quickly sanded down and eventually eliminated.
Always a new character available who might be more "cooperative".
All in all,except for the vultures and the predators, it's a terrible waste of time, funds and good will.
 




Not necessarily "flawed research" at all !!!
Incomplete and bullied research more likely.
Just too much eagerness to get things done quickly, please the management, the shareholders, massage own ego etc.
Of course, then there is simple greed, arrogance and ineptness amongst the "Leadership" (ouch)...so that doesn't help at all.
Any technical person (a vanishing breed) who objects or presents alternative opinions to the mission statement is quickly sanded down and eventually eliminated.
Always a new character available who might be more "cooperative".
All in all,except for the vultures and the predators, it's a terrible waste of time, funds and good will.

From the article, "the issue of irreproducible data has been discussed between scientists for decades".

I think that cancer research provides one of the best places to illustrate why scientific integrity and the use of peer review to catch is probably failing.

In many other areas of science there is an incentive for peer reviewers to be skeptical of purported new findings presented for publication.

1) Many times, due to the lack of "super specialization" there is a much greater chance that someone will be able to detect the fact that even though it was peered reviewed before it was published, the findings of the research were actually not true.

2) The credibility of the entire field of research, and thus the risk to the continued funding of the entire field, is not at risk if a systematic flaw is found through the repeated rejection of papers.

3) Most scientists' research is not so dependent upon other researchers - in oncology, the co-use of cells lines, models etc is widespread.

So, over all these years, the incentive for peer reviewers to reject for publication their peers work, has been much less than in other fields.

Nice work if you can get it.
 




From the article, "the issue of irreproducible data has been discussed between scientists for decades".

I think that cancer research provides one of the best places to illustrate why scientific integrity and the use of peer review to catch is probably failing.

In many other areas of science there is an incentive for peer reviewers to be skeptical of purported new findings presented for publication.

1) Many times, due to the lack of "super specialization" there is a much greater chance that someone will be able to detect the fact that even though it was peered reviewed before it was published, the findings of the research were actually not true.

2) The credibility of the entire field of research, and thus the risk to the continued funding of the entire field, is not at risk if a systematic flaw is found through the repeated rejection of papers.

3) Most scientists' research is not so dependent upon other researchers - in oncology, the co-use of cells lines, models etc is widespread.

So, over all these years, the incentive for peer reviewers to reject for publication their peers work, has been much less than in other fields.

Nice work if you can get it.

Publication of individual laboratory results in a journal (and certainly there is a spectrum of rigor in the individual review mechanisms) is not the same as taking "research" (often internal or sponsored) and broadcasting conclusions about it, and then seeking commercial advantage....sometimes truth be damned...and that happens all too often in the last decade.
And to make matters even more insane, any push back by FDA etc.is met with vitriolic commentary about "preventing innovative medicines from reaching the public" !!! Yikes.
In fact, most of the time the regulatory bodies can only judge claims based upon the manufacturer or marketers own data.....(yikes again).
Yeah, that's been working well ??
 




I don't know what your agenda is or who's interests you represent but you clearly you see and conclude with myopia. There is nothing in this article about generics but you choose to add that to the discussion. This article jumps to none of the conclusions that you do. Unless a company or the medical profession promotes or applies the data from pre-clinical data, it is just that, pre-clinical data. That is call the scientific method. Early trials provide a hypothesis that is confirmed or invalidated by further trials. Please come out from the shadows and declare your true agenda.
 




I don't know what your agenda is or who's interests you represent but you clearly you see and conclude with myopia. There is nothing in this article about generics but you choose to add that to the discussion. This article jumps to none of the conclusions that you do. Unless a company or the medical profession promotes or applies the data from pre-clinical data, it is just that, pre-clinical data. That is call the scientific method. Early trials provide a hypothesis that is confirmed or invalidated by further trials. Please come out from the shadows and declare your true agenda.

Ok, I'll reveal mine by revealing yours.

The FACTS about generics is part and parcel the proof that the majority of the modern pharma industry is a fraud.

If you are involved in a process where you knowingly research, manufacture and sell a product that can be replaced by another product with a lower cost you are a FRAUD.

The FDA publicly publishes the fact that Generics are clinically equivalent to Generics.
Numerous studies have shown that, with Pharma's help, Dr's continue to prescribe labeled drugs instead of equivalent generics.

Thus you are a FRAUD.

Then, you tell yourself stuff like "at least we sell life saving oncology drugs" and this article is but one of many that make a mockery out of that argument.

Only a portion, 30% (?), of the total that we spend as a society on Pharma has a positive effect on anyone's health. And only a small portion of that is because of the effects of pharma sales i.e. new, more effective drugs.

The rest, 70% (?), is basically waisted on paying an Army of researchers who have mostly, over the last 30 years, produced "me-too" labeled drugs that provide no effects over-and-above other existing drugs, including generics, and leadership who uses lobbying, false market place info using paid speakers and then hire the obscene sales forces to go out there and push them.

We will look back on this time and see that Pharma's are today, what cigarette makers were years ago - frauds standing behind misinformation.

The sad part is that this is masks the real positive contribution that pharma makes - fair pricing of the drugs that are needed routinely and the break through drugs when we need them.

As this article EXPLICITLY points out, many clinical trials are begun using this un- reproducible data and thus take away resources from trials that could save lives.

Reproducibly? - hum, I seem to remember that being a part of the scientific method? Now it becomes clear, it is the basis of the modern scientific method.

In freshman physics lab I remember reproducing Galileo's experiment where he rolled balls down inclined planes thus deriving the universal constant for the Gravitational constant. Without and exact knowledge of that number we couldn't do astronomy or go to the moon.

Now we have a credible study that shows that a significant proportion of studies that the oncology field says are fundamental and we have launched numerous trials based upon to be un-reproducible.

Analogy used above - we know G, we send men the the moon successfully.

We think that we know the root causes of many form of cancer but the studies are flawed - we spend 40 years a $ billions on clinical studies with limited results; sometimes succeeding but mostly failing.

I think that the later best describes the reality, it is NOT the result of a Scientific method and this study show why.
 




Ok, I'll reveal mine by revealing yours.

The FACTS about generics is part and parcel the proof that the majority of the modern pharma industry is a fraud.

If you are involved in a process where you knowingly research, manufacture and sell a product that can be replaced by another product with a lower cost you are a FRAUD.

The FDA publicly publishes the fact that Generics are clinically equivalent to Generics.
Numerous studies have shown that, with Pharma's help, Dr's continue to prescribe labeled drugs instead of equivalent generics.

Thus you are a FRAUD.

Then, you tell yourself stuff like "at least we sell life saving oncology drugs" and this article is but one of many that make a mockery out of that argument.

Only a portion, 30% (?), of the total that we spend as a society on Pharma has a positive effect on anyone's health. And only a small portion of that is because of the effects of pharma sales i.e. new, more effective drugs.

The rest, 70% (?), is basically waisted on paying an Army of researchers who have mostly, over the last 30 years, produced "me-too" labeled drugs that provide no effects over-and-above other existing drugs, including generics, and leadership who uses lobbying, false market place info using paid speakers and then hire the obscene sales forces to go out there and push them.

We will look back on this time and see that Pharma's are today, what cigarette makers were years ago - frauds standing behind misinformation.

The sad part is that this is masks the real positive contribution that pharma makes - fair pricing of the drugs that are needed routinely and the break through drugs when we need them.

As this article EXPLICITLY points out, many clinical trials are begun using this un- reproducible data and thus take away resources from trials that could save lives.

Reproducibly? - hum, I seem to remember that being a part of the scientific method? Now it becomes clear, it is the basis of the modern scientific method.

In freshman physics lab I remember reproducing Galileo's experiment where he rolled balls down inclined planes thus deriving the universal constant for the Gravitational constant. Without and exact knowledge of that number we couldn't do astronomy or go to the moon.

Now we have a credible study that shows that a significant proportion of studies that the oncology field says are fundamental and we have launched numerous trials based upon to be un-reproducible.

Analogy used above - we know G, we send men the the moon successfully.

We think that we know the root causes of many form of cancer but the studies are flawed - we spend 40 years a $ billions on clinical studies with limited results; sometimes succeeding but mostly failing.

I think that the later best describes the reality, it is NOT the result of a Scientific method and this study show why.

and the response? . . . . . . . "chirp. . . . . chirp . . . . chirp" (the sounds crickets make).
 




I don't know what your agenda is or who's interests you represent but you clearly you see and conclude with myopia. There is nothing in this article about generics but you choose to add that to the discussion. This article jumps to none of the conclusions that you do. Unless a company or the medical profession promotes or applies the data from pre-clinical data, it is just that, pre-clinical data. That is call the scientific method. Early trials provide a hypothesis that is confirmed or invalidated by further trials. Please come out from the shadows and declare your true agenda.

Just adding to the response stream...
Pharma is built on greed and bullshit...now the over fed chickens are coming home to take a crap.
Science indeed !!!!!!!!!!!!!!!!
 












and there is something wrong with what i do, or who i am - but not you?

what you and say is more moral and ethical than me?

how do i become more moral and ethical like you? Get on a site that provides a industry related forum and blab? If somebody asks a question you dump on them.
 




and there is something wrong with what i do, or who i am - but not you?

what you and say is more moral and ethical than me?

how do i become more moral and ethical like you? Get on a site that provides a industry related forum and blab? If somebody asks a question you dump on them.

the vast majority of the porfits the company makes, pays your salary with and wall street gives them credit for in thier stock price for is fraudulenty and dishonestly made. If you company makes a product that is more expensive than an equivalent then they are a fraud. Selling branded drugs, paying people like you to go out and infuence DRs to do so when all the most infuential medical organizations in the country are trying to educate DRs not to do, then you are an immoral fraud.

These are facts no opnions.
 




If a product is deemed safe ie non-prescription status by the FDA - and it has recommended doses and public safety notices where, and what ever, is required on the label an in advertising - then how is it a fraud...brand or generic?

If somebody takes a kitchen knife and slices their finger - it's the individuals fault...not edge. If one stabs somebody - it is the individual hurting somebody...not the knife.
One knife might be prettier or better than another - but they're all capable of doing the same thing...cutting.

If I'm out there selling knives to MDs - showing them the features and benefits, telling them exactly how it's to be used: either for carving meat or slicing vegetables. Maybe the handles are a little different - colors etc. As is every other knife Rep is. We all have the same basic product - just here are the differences and what the FDA, and other recognized authorities who stake their institution's reputation and their's as well say about blah blah blah....

You think the MD cares any - really? He just likes my "style and approach" the fact I feed his staff is no different than any other knife Rep. The fact my knives are no different than the others in it's ability to do one basic fact, and that is cut. But MY knives have different handles - and that makes all the difference in the world. My handles are Florescent Zombie Killer Goblin Green - you can see 'em at night - and day. My competitor's handles are standard - if there is a Zombie attack at night where are you with my competitor's knife? Maybe it was hanging where you left it - maybe you didn't put it back, but then where...? Your knife, my competitor, is a great knife - in fact both our blades are exactly the same in doing what they're suppose to do. No difference there - that's why I say they're a great knife, and they have to admit the same of ours.

Except - my blade is Florescent Zombie Killer Goblin Green BUDDY!!! Here - BEFORE - I unsheath this knife - put on these sunglasses. Oh yeah - the blade is that bright. (Of course this is gimmick). You can see it ANYWHERE. Buddy, get this, - at night....it glows. How about that? Hun? Trick isn't it? But HEY, There is a real thought behind this.....

Maybe you didn't put it back where you thought you did, but don't worry - you're not going to expose your position by turning on the lights of your hide-out IF you own this knife, the FZKGG knife...just look for the glow...safety is within eyesight. EVERYTIME - ALL THE TIME - DAY or NIGHT! WhooooEEEEeee ain't no Zombie safe now!

Still - my knifes are just that - a knife - like any other knife in all that is suppose to do. Cut.

Maybe I spend a little time educating him on knife terminology (nobody else does, but I do), maybe I expend effort talking to him about our warranties and service (everybody has the same, but nobody explains it to him - but I do). Maybe I sharpen all his knives for free - his one time, ours for life. Maybe it's just my knives are Florescent Zombie Killer Goblin Green.

I have that FZKGG Knife (for real - I do, honest) and all that focus for that MD's knife business- I had to spend some money to "buy" my time and get his attention at lunch...yeah I buy the office staff lunch. By the way he isn't blown away with that gesture - he's treated daily by somebody. That and his bloated sniveling staff snarking up at the catered food trough doesn't care either. It's a jaded trade for time, and it's an expected practice.

Oh yeah - one last warning I tell him to be careful who he gives these knives to. First they must be old enough to hold one and understand responsibility. Second they have to have physical ability to hold one...ie enough fingers - and or artificial mechanical dexterity to manipulate one safely. We can't account for stupidity or carelessness, knives are dangerous and at this time knives still don't require a prescription.

SOOOooooo I don't know where the fraud is unless it's you just don't believe in Zombies. And if you don't - well....just don't go around saying you don't.
 




If a product is deemed safe ie non-prescription status by the FDA - and it has recommended doses and public safety notices where, and what ever, is required on the label an in advertising - then how is it a fraud...brand or generic?

If somebody takes a kitchen knife and slices their finger - it's the individuals fault...not edge. If one stabs somebody - it is the individual hurting somebody...not the knife.
One knife might be prettier or better than another - but they're all capable of doing the same thing...cutting.

If I'm out there selling knives to MDs - showing them the features and benefits, telling them exactly how it's to be used: either for carving meat or slicing vegetables. Maybe the handles are a little different - colors etc. As is every other knife Rep is. We all have the same basic product - just here are the differences and what the FDA, and other recognized authorities who stake their institution's reputation and their's as well say about blah blah blah....

You think the MD cares any - really? He just likes my "style and approach" the fact I feed his staff is no different than any other knife Rep. The fact my knives are no different than the others in it's ability to do one basic fact, and that is cut. But MY knives have different handles - and that makes all the difference in the world. My handles are Florescent Zombie Killer Goblin Green - you can see 'em at night - and day. My competitor's handles are standard - if there is a Zombie attack at night where are you with my competitor's knife? Maybe it was hanging where you left it - maybe you didn't put it back, but then where...? Your knife, my competitor, is a great knife - in fact both our blades are exactly the same in doing what they're suppose to do. No difference there - that's why I say they're a great knife, and they have to admit the same of ours.

Except - my blade is Florescent Zombie Killer Goblin Green BUDDY!!! Here - BEFORE - I unsheath this knife - put on these sunglasses. Oh yeah - the blade is that bright. (Of course this is gimmick). You can see it ANYWHERE. Buddy, get this, - at night....it glows. How about that? Hun? Trick isn't it? But HEY, There is a real thought behind this.....

Maybe you didn't put it back where you thought you did, but don't worry - you're not going to expose your position by turning on the lights of your hide-out IF you own this knife, the FZKGG knife...just look for the glow...safety is within eyesight. EVERYTIME - ALL THE TIME - DAY or NIGHT! WhooooEEEEeee ain't no Zombie safe now!

Still - my knifes are just that - a knife - like any other knife in all that is suppose to do. Cut.

Maybe I spend a little time educating him on knife terminology (nobody else does, but I do), maybe I expend effort talking to him about our warranties and service (everybody has the same, but nobody explains it to him - but I do). Maybe I sharpen all his knives for free - his one time, ours for life. Maybe it's just my knives are Florescent Zombie Killer Goblin Green.

I have that FZKGG Knife (for real - I do, honest) and all that focus for that MD's knife business- I had to spend some money to "buy" my time and get his attention at lunch...yeah I buy the office staff lunch. By the way he isn't blown away with that gesture - he's treated daily by somebody. That and his bloated sniveling staff snarking up at the catered food trough doesn't care either. It's a jaded trade for time, and it's an expected practice.

Oh yeah - one last warning I tell him to be careful who he gives these knives to. First they must be old enough to hold one and understand responsibility. Second they have to have physical ability to hold one...ie enough fingers - and or artificial mechanical dexterity to manipulate one safely. We can't account for stupidity or carelessness, knives are dangerous and at this time knives still don't require a prescription.

SOOOooooo I don't know where the fraud is unless it's you just don't believe in Zombies. And if you don't - well....just don't go around saying you don't.

The fraud is that your company sells drugs at a higher proce than is required. That is ending and it is the end to the vast majority of those in your profession. Suck on that "knife"!
 




The Zombie poster forgot to ask for the business. ha. Uhh - what fraud is there? Everything being equal between generic and brand, one company wants to charge more and another less, constitutes fraud?

Hi? Who would you like to buy from? This ugly guy selling drug A, cheaper than the pretty girl is selling it? Oh - you want to buy it from her? Because it's more expensive? No? Because she's pretty, and you want to pay more for that? Yes? Oh. Okay. Where is the fraud?

Nobody is fooling MDs with their products/marketing. Seriously - you think a brat out of college (with Brand Team wisdom) is going to BS today's MD? Even way back when, in the "lawless" days Reps were not fooling MDs - just enticing them and getting in trouble with graft and sample fraud. It ain't nowhere like that - you might have exceptions and even those are getting rarer and rarer...

Today's MD doesn't give a shit about a walking talking PI that serves lunch. There is no fraud in choice.
 




The Zombie poster forgot to ask for the business. ha. Uhh - what fraud is there? Everything being equal between generic and brand, one company wants to charge more and another less, constitutes fraud?

Hi? Who would you like to buy from? This ugly guy selling drug A, cheaper than the pretty girl is selling it? Oh - you want to buy it from her? Because it's more expensive? No? Because she's pretty, and you want to pay more for that? Yes? Oh. Okay. Where is the fraud?

Nobody is fooling MDs with their products/marketing. Seriously - you think a brat out of college (with Brand Team wisdom) is going to BS today's MD? Even way back when, in the "lawless" days Reps were not fooling MDs - just enticing them and getting in trouble with graft and sample fraud. It ain't nowhere like that - you might have exceptions and even those are getting rarer and rarer...

Today's MD doesn't give a shit about a walking talking PI that serves lunch. There is no fraud in choice.

If you are involved in selling a branded drug to a Doc thta could have been replaced with a generic you are a fraud. The largest professional clinical medical organizations think so. So do the largest teaching hospitals as all of these orgs have Doc training programs to try and educate Docs not to choose you fraud.

How do you sleep at night? Let me guess, "very well thank you".

Obama Care begins to take the trough away from you frauds.
 




If you are involved in selling a branded drug to a Doc thta could have been replaced with a generic you are a fraud. The largest professional clinical medical organizations think so. So do the largest teaching hospitals as all of these orgs have Doc training programs to try and educate Docs not to choose you fraud.

How do you sleep at night? Let me guess, "very well thank you".

Obama Care begins to take the trough away from you frauds.


If a company REALLY discovers and develops a new and safe and efficacious drug, then they deserve all the reasonable protections of IP etc., as well as premium but not predatory pricing !!!!
But that's not what's happening at all.
Either they are "buying in" compounds from groups who can no longer make it financially because they don't sell over priced consumer products as well, or don't have powerful lobby buddies....OR, as is more common and likely,, we are putting forward "me-too" formulations with extravagant claims or marketing prowess.....OR, as is much worse...putting forward compounds with incomplete or cherry-picked clinical data and then screaming bloody murder that the evil FDA is holding up "innovation" !!!!!!!!!!!!

It's not "fraudulent science"...it's greedy people committing fraud with science !!!!!
 




If you are involved in selling a branded drug to a Doc thta could have been replaced with a generic you are a fraud. The largest professional clinical medical organizations think so. So do the largest teaching hospitals as all of these orgs have Doc training programs to try and educate Docs not to choose you fraud.

How do you sleep at night? Let me guess, "very well thank you".

Obama Care begins to take the trough away from you frauds.

I don't see the fraud. You go to the store - store A has tennis shoe at one price, store B has tennis shoe at cheaper price. You buy one or the other...where is the fraud? Unless it's your intelligence over allowing people freedom of choice.

*yawn* this bores me...as does AHCA
 




If a company REALLY discovers and develops a new and safe and efficacious drug, then they deserve all the reasonable protections of IP etc., as well as premium but not predatory pricing !!!!
But that's not what's happening at all.
Either they are "buying in" compounds from groups who can no longer make it financially because they don't sell over priced consumer products as well, or don't have powerful lobby buddies....OR, as is more common and likely,, we are putting forward "me-too" formulations with extravagant claims or marketing prowess.....OR, as is much worse...putting forward compounds with incomplete or cherry-picked clinical data and then screaming bloody murder that the evil FDA is holding up "innovation" !!!!!!!!!!!!

It's not "fraudulent science"...it's greedy people committing fraud with science !!!!!

The majority of branded drugs offer absultely no benefit above and beyond the generics that could be substitutued for them. That is a fact.
 




ZKGG poster here - what intrigues me is somebody pointing a finger at somebody yelling fraud! - but can't defend profit, freedom, choice, and although I think he is quite stupid, can't defend smart people making stupid decisions either. That boy's got a bugs in his head - watch him.