Indian Government uses special powers to slash cancer drug price by 97% • Hacker News Board

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

#101

Post by Produce » Tue, Mar 13, 2012, 2:25 PM UTC

betterth wrote: post #90

tripzilch wrote: post #65

Earlier quoted context omitted.

But most of those R&D costs are for getting "FDA" approval. I don't see why India (or anyone, really) should pay for lining the pockets of the USA's inefficient and corrupt bureaucratic machinery. Or I could be wrong and those $12B really goes into equipment and lab workers wages, but you won't blame me for finding it real hard to believe until I see at least a rough breakdown of how those costs are summed up. From t…

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 taking such a long time to break through into the mainstream. Politics play a huge role in business and tend to turn it into a theater of the absurd.

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

#102

Post by jbooth » Tue, Mar 13, 2012, 2:27 PM UTC

crusso wrote: post #67

x3c wrote: post #55

I propose the following solution. R&D stays in private sector. All successful drugs are bought by the government at the cost of R&D and a sizable profit. The government, then, distributes it. Government can control the distribution and Pvt. markets can control the invention. Government can then tie up with other govts. and allow sales of the said medicine in those countries. It's not an ideal solution, but it has bes…

So the government then picks "successful drugs" and hands out massive amounts of money to those companies based on the definition of success as determined by politicians, bureaucrats, and lobbyists. Sounds like a nonstarter to me.

I'm not advocating for the proposal necessarily, but it's worth pointing out that a solution could be all kinds of bad yet still better than the mess we have today.

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

#103

Post by sanderoak » Tue, Mar 13, 2012, 2:30 PM UTC

finally atleast 1 government has the common sense i was waiting for!

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

#104

Post by SystemOut » Tue, Mar 13, 2012, 2:31 PM UTC

tripzilch wrote: post #65

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…

But most of those R&D costs are for getting "FDA" approval. I don't see why India (or anyone, really) should pay for lining the pockets of the USA's inefficient and corrupt bureaucratic machinery. Or I could be wrong and those $12B really goes into equipment and lab workers wages, but you won't blame me for finding it real hard to believe until I see at least a rough breakdown of how those costs are summed up. From t…

Don't you think that the drug companies would have found cheaper ways to develop drugs since they've realized that people will still pay them? That would lead to even higher profits.

It's insanely difficult to bring a new drug to market. Imagine all of the crazy combinations of people that take them and if you miss one small group that has an adverse reaction you could be talking 1000s of people that are lining up to sue you out of existence or if you're in another company the regulatory body doing it for them. People around the world benefit immensely from our "inefficient and corrupt bureaucratic machinery" because they get safe drugs.

Also, from the article, "Bayer tried to justify its high price by making claims of high R&D costs, but refused to provide any details". This is just plain rhetoric plain and simple. You see politicians do this everyday because there is no real way to refute it.

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

#105

Post by Produce » Tue, Mar 13, 2012, 2:32 PM UTC

nikcub wrote: post #99

Produce wrote: post #94

Earlier quoted context omitted.

>The more drugs we know, the harder it is to prove that the new drug you propose is better than current therapy. No it's not. Example: 1980: Drug A is invented to treat illness X, proves to be the most effective 1990: Drug B is invented for illness X, effectiveness is tested against Drug A 2000: Drug C is invented for illness X, effectiveness is tested against Drug B 2010: Drug D is invented for illness X, effectiven…

for some reason the placebo effect is getting stronger and more drugs are failing in stage II and III against sugar: http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo...

I'm honestly gobsmacked that our model of health and physiology is so primitive that it doesn't use the most widely available treatment as a first line approach, which, as you point out, is the placebo effect. Why are so many resources being wasted on developing new chemicals when the brain can seemingly perform the same functions with nothing? I get that for a lot of things you need a physical intervention, but should this not be the last resort as it tends to have the most side effects?

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

#106

Post by vannevar » Tue, Mar 13, 2012, 2:34 PM UTC

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 statistics to show some marginal benefit for a chosen winner, and a big marketing budget and the placebo effect takes care of the rest. Thanks to this model, we've finally conquered the scourges of restless leg syndrome, overactive bladder, and general anxiety disorder.

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

#107

Post by leonth » Tue, Mar 13, 2012, 2:37 PM UTC

Produce wrote: post #94

leonth wrote: post #77

Earlier quoted context omitted.

It does not go down. The more drugs we know, the harder it is to prove that the new drug you propose is better than current therapy. A proposed molecule that does not have significant advantage compared to the current gold standard will never sell. To put it in another way: all the low-hanging fruits are already taken. Add to the fact that science progresses; we now know more about the human body and generally everyt…

>The more drugs we know, the harder it is to prove that the new drug you propose is better than current therapy. No it's not. Example: 1980: Drug A is invented to treat illness X, proves to be the most effective 1990: Drug B is invented for illness X, effectiveness is tested against Drug A 2000: Drug C is invented for illness X, effectiveness is tested against Drug B 2010: Drug D is invented for illness X, effectiven…

Yes it is. It is not about the cost of comparing 2 products, it is about market saturation. When 2010 came, drug A would be off-patent and evidence for using A would be piling up. As a doctor that cares about his patient, one would very reasonably choose drug A over the still-on-patent drug D which is only slightly more effective but since it's new the evidence is weaker (as in -- will this work for the relevant genetic makeup, disease state profile, microbial resistance pattern for antibiotics, is this better efficacy real and not just some shady number crunching by big pharma etc.), nobody exactly knows the long-term side effects, and it's much more expensive. Do you think that the pharma would spend millions to face this bleak market?

(EDIT: this assumes that drug A works "satisfactorily". Drug D still have a chance if it has markedly differentiating features, say if drug A is injected while drug D is taken orally.)

(as a side note, cancer drugs are hot because of precisely opposite of these -- most are fairly new, those that are old are not exactly pleasant to take, there is no "silver bullet" found yet so there are lots of room for improvement.)

Another take on the market saturation is that when the current therapy is simply already good enough, ie. the "silver bullet" has been discovered. That's the reason why there has been no new drugs developed for headache in recent few years (or pain management drugs in general). It's a totally different story when, say, aspirin was first introduced: there is a lot more room to improve on / differentiate from its side effect profile, pharmacological properties, etc.

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

#108

Post by Alex3917 » Tue, Mar 13, 2012, 2:39 PM UTC

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 fines per year than the entire military industrial complex:

http://www.citizen.org/hrg1924

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

#109

Post by driverdan » Tue, Mar 13, 2012, 2:39 PM UTC

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…

> 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. Methamphetamines are neurotoxic, especially in recreational doses, but non-methylated amphetamines are not.

> Funny how medical marijuana is taking such a long time to break through into the mainstream.

Entirely different issue.

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

#110

Post by tomjen3 » Tue, Mar 13, 2012, 2:40 PM UTC

Produce wrote: post #100

crusso wrote: post #79

Earlier quoted context omitted.

And if they lower the price drastically in India and then are accused of gouging their customers in other countries? When they lower the price of the drug in India, a gray market arises that resells the drugs to other countries. The presence of the gray market creates yet more opportunities for scam artists to sell fake versions of the drug, creating yet more victims. My point is that this isn't as cut and dry of an…

Human lives are at stake, there's nothing more cut and dry than that. We need to stop trying to make our reality fit our models and start adapting our models to fit reality. This whole business is backwards.

Yes human lives are at stake. All the people who invested their stock money in Bayer and plane to retire some day. All the people who depend on the drugs the company makes and so on.