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Indian Government uses special powers to slash cancer drug price by 97%

timesofindia.indiatimes.com

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Re: Indian Government uses special powers to slash cancer drug price by 97%

#111

Post by betterth »

Produce wrote: post #101
betterth wrote: post #90

Earlier quoted context omitted.

The majority of the money goes into Phase III clinical trials. Don't bash the FDA - they're the most evidence based, scientifically minded regulatory body in our government. Preclinical and Phase I - II trials aren't too expensive, in the order of millions of dollars. But also remember, for every ~10,000 candidates that enter preclinical trials, about 1-2 will actually pass FDA approval. The billion number isn't just…

>But the FDA is the most strict drug regulatory body in the world, and the amount of evidence for efficacy that they require from the industry is truly impressive and truly does warrant the billions price tag. Funny how there are so many SSRI's on the market. Funny how this model results in the conclusion that it's a good idea to give kids amphetamines when they are known neurotoxins. Funny how medical marijuana is t…

The FDA is not an ethics organization that evaluates drugs based on the total effect of public health. That simply isn't contained in the bevy of Bills that together form the Code that FDA mandate is derived from. I understand how frustrating watching these public health issues is, but the FDA isn't tasked with that, and only Congress can change that.

The FDA does something else: Drug company says they have a drug that does X. Does the drug do X?

That's it (okay, the FDA regulates a lot, but in the context of pharmaceuticals, this is their mandate -- "efficacy"). They require inordinate amounts of proof of efficacy.

Not the morality or ethics behind the application of the drug, but rather: does this molecule, in this concentration, in this delivery route, in this population, have the exact pharmacological effect that they claim it does.

From there, it is up to each person and their doctor to decide what treatments are needed!

Blame the doctors, then, or blame Congress, but the FDA follows it's mandate quite wonderfully.

Re: Indian Government uses special powers to slash cancer drug price by 97%

#112

Post by jerf »

nknight wrote: post #56
JunkDNA wrote: post #36

I worked in the drug R&D business for over 8 years. I still follow the industry closely. Some things always get lost in these discussions. First, manufacturing an existing drug is absurdly cheap. Modern industrial chemistry ensures this for all small molecule drugs (note that this is not the same case for the "biologics" which are often fiendishly difficult to make). Almost all the cost in a drug is the manufacturer…

> You don't need to be an industry expert to grok that those numbers are wildly unsustainable. Tell you what. When these companies stop being the most profitable in America, or even just when their EPS starts declining, I'll believe you.

Take a closer look at the post, and you'll see that what JunkDNA just said is that is going to happen, and hard. Right now they run about a 17% profit margin [1]. If they lose their cash cows en masse, that's going to go negative, fast. That's not that great a profit margin from that point of view.

What are they going to do then? The only thing they really can, slash costs. It seems unlikely the all the slashing is going to come out of everything except R&D.

We're ultimately going to have to deal with the fact that as a society we've chosen to make it extremely expensive to bring new drugs to market. Basically, our extremely high standards are/were sustainable only because we also gave them patent protection. It is going to be economically infeasible to have both extremely high standards for new drugs, then refuse to protect them for long enough to recoup their costs. There is no law of economics that says a thing must be produced; raise the cost above what can be recovered and what happens is that it won't be produced.

[1]: http://biz.yahoo.com/p/sum_qpmd.html

Re: Indian Government uses special powers to slash cancer drug price by 97%

#113

Post by betterth »

driverdan wrote: post #109
Produce wrote: post #101

Earlier quoted context omitted.

>But the FDA is the most strict drug regulatory body in the world, and the amount of evidence for efficacy that they require from the industry is truly impressive and truly does warrant the billions price tag. Funny how there are so many SSRI's on the market. Funny how this model results in the conclusion that it's a good idea to give kids amphetamines when they are known neurotoxins. Funny how medical marijuana is t…

> Funny how there are so many SSRI's on the market. Why? What's wrong with SSRIs? > Funny how this model results in the conclusion that it's a good idea to give kids amphetamines when they are known neurotoxins. Giving amphetamines to children is certainly debatable but amphetamines are not neurotoxic. Meth amphetamines are neurotoxic, especially in recreational doses, but non-methylated amphetamines are not. > Funny…

Funny thing about meth is that it's not that dangerous -- it's almost identical to adderral. The methyl group (meth-amphetamine vs amphetamine) really only improves the ability of the drug to cross the blood-brain barrier. It's basically a form of adderal with a slightly stronger bioavailability curve.

The reason why meth is a public health issue while addy arguably is not is mainly because requiring a Doctor rx, using an exact dosage with no refills, combined with the purity and safety of GMP-produced drugs, eliminates most of the issues behind meth.

I was shocked when I found how just how similar meth and adderall truly are.

Re: Indian Government uses special powers to slash cancer drug price by 97%

#114

Post by mjallday »

Alex3917 wrote: post #108
JunkDNA wrote: post #36

I worked in the drug R&D business for over 8 years. I still follow the industry closely. Some things always get lost in these discussions. First, manufacturing an existing drug is absurdly cheap. Modern industrial chemistry ensures this for all small molecule drugs (note that this is not the same case for the "biologics" which are often fiendishly difficult to make). Almost all the cost in a drug is the manufacturer…

> Almost all the cost in a drug is the manufacturer recouping R&D costs. Actually that's not true. Big pharma spends twice as much on advertising as they do on R&D: http://www.sciencedaily.com/releases/2008/01/080105140107.ht... They also spend a significant amount of money on government fines due to corrupt practices (i.e. killing people). They are now the single most corrupt industry, paying significantly more fine…

Is paying fines corrupt? I would say that dodging fines would be considerably more corrupt.

Re: Indian Government uses special powers to slash cancer drug price by 97%

#115

Post by onemoreact »

Retric wrote: post #53
JunkDNA wrote: post #36

I worked in the drug R&D business for over 8 years. I still follow the industry closely. Some things always get lost in these discussions. First, manufacturing an existing drug is absurdly cheap. Modern industrial chemistry ensures this for all small molecule drugs (note that this is not the same case for the "biologics" which are often fiendishly difficult to make). Almost all the cost in a drug is the manufacturer…

There are a finite number of useful small molecules you can use as drugs. If it's costing 3-12 billion to find new ones and even then we are failing we may be at a point where it's time to 'give up' on our existing approach. As an upside we can remove a significant slice of our spiraling healthcare costs. We can also remove a lot of drug related advertizing that has dubious healthcare benefits. Unfortunately, that al…

Why the down votes? Diminishing returns is a real issue and randomly testing chemicals until one happens to work for something is hardly the most effective approach possible.

Re: Indian Government uses special powers to slash cancer drug price by 97%

#116

Post by man1sh »

mjallday wrote: post #114
Alex3917 wrote: post #108

Earlier quoted context omitted.

> Almost all the cost in a drug is the manufacturer recouping R&D costs. Actually that's not true. Big pharma spends twice as much on advertising as they do on R&D: http://www.sciencedaily.com/releases/2008/01/080105140107.ht... They also spend a significant amount of money on government fines due to corrupt practices (i.e. killing people). They are now the single most corrupt industry, paying significantly more fine…

Is paying fines corrupt? I would say that dodging fines would be considerably more corrupt.

They pay fines for their corrupt behavior. You understood it wrong

Re: Indian Government uses special powers to slash cancer drug price by 97%

#117

Post by man1sh »

gaius wrote: post #21
man1sh wrote: post #19

Earlier quoted context omitted.

also don't forget that for these companies the poor people in India are the subjects of clinial trials. The mindset of these companies of treating the poor people as Guinea pigs is also disgusting 671 reported deaths http://www.business-standard.com/india/news/human-rights-pan... There is no count of no of people who get disabilities but don't die due to trials failing. Who will pay for these? These pharma companies…

I am referring to FDA trials, in the US, which can take over a decade and cost 8- or 9-figure dollar sums. These are required before the drug even comes to market.

They cannot afford clinical trials in developed countries, so they turn to poorer countries.

India is one of the biggest hub for most of the pharma's clinical trials due to huge poor population. The rules are lax and they take advantage of it. Lot of people die and many turn paralyzed or disabled permanently due to drug's unknown side-effect.

These corrupt pharma companies want to use India as it's test-bed but want to sell the drugs tested here at an abysmal high price such that it is even out of my reach (even though I am well off).

Re: Indian Government uses special powers to slash cancer drug price by 97%

#118

Post by dlytle »

betterth wrote: post #113
driverdan wrote: post #109

Earlier quoted context omitted.

> Funny how there are so many SSRI's on the market. Why? What's wrong with SSRIs? > Funny how this model results in the conclusion that it's a good idea to give kids amphetamines when they are known neurotoxins. Giving amphetamines to children is certainly debatable but amphetamines are not neurotoxic. Meth amphetamines are neurotoxic, especially in recreational doses, but non-methylated amphetamines are not. > Funny…

Funny thing about meth is that it's not that dangerous -- it's almost identical to adderral. The methyl group (meth-amphetamine vs amphetamine) really only improves the ability of the drug to cross the blood-brain barrier. It's basically a form of adderal with a slightly stronger bioavailability curve. The reason why meth is a public health issue while addy arguably is not is mainly because requiring a Doctor rx, usi…

As an Adderall user, I can back this up. The symptoms of use are very similar to meth. Ever seen that "meth jingle" ad? The whole "pulling hairs out of your face, cleaning everything, etc" pitch is spot on to Adderall side effects. The difference is that Adderall side effects are dramatically more mild due to (as betterth said) a properly calibrated and reliable dose.

Also, with Adderall, you can't afford to just take more to offset withdrawal symptoms, because you only have so much. The temptation to take another as it wears off is pretty substantial, especially for long-time users.

Re: Indian Government uses special powers to slash cancer drug price by 97%

#119

Post by liber8 »

man1sh wrote: post #116
mjallday wrote: post #114

Earlier quoted context omitted.

Is paying fines corrupt? I would say that dodging fines would be considerably more corrupt.

They pay fines for their corrupt behavior. You understood it wrong

Simply because you are forced to pay fines doesn't mean you are "corrupt".

The abstract indicates most of the fines come from "illegal off-label drug promotion" and "overcharging state governments". It could be argued that the first shouldn't even be an issue, and the second, depending on how "overcharging" is defined could be outright fraud on the part of big pharma, fraud on the part of state governments, or something in between.

Re: Indian Government uses special powers to slash cancer drug price by 97%

#120

Post by roadnottaken »

vannevar wrote: post #106
JunkDNA wrote: post #36

I worked in the drug R&D business for over 8 years. I still follow the industry closely. Some things always get lost in these discussions. First, manufacturing an existing drug is absurdly cheap. Modern industrial chemistry ensures this for all small molecule drugs (note that this is not the same case for the "biologics" which are often fiendishly difficult to make). Almost all the cost in a drug is the manufacturer…

Somewhere out there, a business model is waiting to be found. I hope so, because the current one isn't working for consumers. Even with the billions spent on R&D, it turns out that many of the drugs Big Pharma turns out are no better than placebos. It's not hard to see why: a big company spends X amount on each failure and needs a 10X hit to offset the costs. If one doesn't materialize, it's not hard to rig the stati…

Actually it's almost impossible to rig the statistics. And every drug on the market has shown efficacy compared to placebo in large tests calle phase 3 clinical trials.
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