7 ms·

Prostate cancer drug so effective trial stopped

149 points by joeyespo 14y ago

pixelcort 14y ago
This has interesting implications to the recent discussions about A/B testing and Multi-armed bandit algorithms. Assuming double blind tests are akin to A/B testing, at what point was the trial stopped? Was it stopped before there was statistical significance? Or, are there differences in how double blind tests are done than how A/B testing is done in software and websites?
- deleted 14y ago
  [deleted]
  - refurb 14y ago
    What do you mean by triple blinded? The research was double-blinded, what more are you looking for?
    - deleted 14y ago
      [deleted]
    - saurik 14y ago
      http://medical-dictionary.thefreedictionary.com/_/dict.aspx?word=triple+blind http://medical-dictionary.thefreedictionary.com/_/dict.aspx?...
      - refurb 14y ago
        OK, but what makes you think this wasn't triple-blinded? I've never heard a clinical trial called that, but usually the data analysts don't know which patients got the drug either.
- planetguy 14y ago
  at what point was the trial stopped? Was it stopped before there was statistical significance? I'm guessing... no. I'm guessing they don't call off a zillion-dollar phase III clinical cancer drug trial without running it by someone who has glanced at an undergrad statistics textbook. We're not just banging rocks together here, guys, we know how to do clinical trials.
  - DanBC2 14y ago
    > We're not just banging rocks together here, guys, we know how to do clinical trials. There are many problems with clinical trials. Read Ben Goldacre for examples. One problem is that good results are published, while bad results (when they're submitted, which isn't often) are too boring for publication. And then there are all the other problems of studies that aren't correctly blinded, or the selection is faulty, or etc. These are all reputable pharma companies with substantial funds to run tests. I am, obviously, addressing your comment because there's not nearly enough detail in the article to discuss.
    - refurb 14y ago
      Often bad clinical trial results aren't released because they are bad for reasons other than the drug doesn't work. Also, it's very rare for big pharma companies to screw up a clinical trial. It's much more common in the small biotechs and non-profits. If there is one thing that big pharma companies are good at is drug development (not so much drug research).
      - DanBC2 14y ago
        So a big pharma company like Merck wouldn't use a big publishing company like Elsevier to create fake "medical" journals and publish research? https://www.google.co.uk/search?&q=elseviers+fake+journal+merck https://www.google.co.uk/search?&q=elseviers+fake+journa...
        streptomycin 14y ago
        What does that have to do with clinical trials? You're not being logically coherent. The FDA isn't going to approve a drug because someone makes a fake journal and publishes some results in it.
- jerf 14y ago
  We are hearing about this precisely because it is unusual and thus newsworthy. This article is light on the scientific details. Given those things, let's extend them the benefit of the doubt for now and hold the standard (and somewhat tedious) litany of complaints until there's more evidence that they are called for, as exceptional actions in such a tightly regulated domain is reasonably likely to imply exceptional circumstances.
- Mvandenbergh 14y ago
  No. The effect size was large enough that the statistical significance agreed with the FDA before the start of the study was reached well before the end of the trial. This is not uncommon, and the possibility of ending the trial early will have been decided beforehand. Usually an independent advisory board not affiliated with the FDA or the pharma company will make these decisions - the other parties may not even have known that the results were better than expected until the independent board decided to end the study.
- Gatsky 14y ago
  I was at the announcement of the trial data by the investigators this morning. The results were also discussed by a statistician not involved with the trial directly. Not sure that hacker news needs an in depth analysis of the trial design and outcome, but anyway... In summary, the trial looked at patients who had incurable prostate cancer that had spread and stopped responding to traditional hormonal treatments. Patients had to have no symptoms to be enrolled on this trial. The trial compared abiraterone, a new type of hormonal treatment plus steroids to just being on steroids alone. The question that the trial was asking can be framed as "Does taking abiraterone prolong the period of time that a patient can be symptom free and their cancer is under control?" That was the primary endpoint. A secondary endpoint was survival, or how long they lived. Built in to the study design was a planned interim analysis of the data. Normally, the investigators are not allowed to just look at the data as it accrues continuously because it creates bias. It is a standard approach to allow one look at the data when say 40% of the expected events (in this case, development of progressive cancer) have occurred. When they did this, the difference between getting the drug and not getting the drug was considered big enough to unblind the trial. This means that everyone finds out if they were getting placebo or the real drug. There are multiple reasons why one may decide to do this. First and foremost is that if the drug really works, it would be unethical to leave people on a placebo for long periods, because it is clear they have an inferior outcome. Stopping early also speeds the time to drug approval and market entry for a given indication. There are somewhat esoteric statistical procedures that can determine at an interim analysis if the accrued data shows a statistically significant difference between groups, which would therefore justify stopping the trial, while adjusting for the impact of repeated testing on the type I error rate (ie the chance of finding an association that doesn't really exist). In this trial, there is no doubt that the primary endpoint was positive and clinically and statistically significant, even with only 40% of people on the trial having had a progression event. So they stopped. The data on whether abiraterone reduces the chance of death are not mature, because not enough of the people on the trial have died yet, so those results will be awaited. Stopping early means that these results may be biased however, because the trial is no longer blinded. This was a large and well done trial, that employed standard statistical practices.
  - firebones 14y ago
- m104 14y ago
  No interesting implications, just the reaffirmation that real significance is more important than statistical significance.
novalis 14y ago
This brings great hope to all affected and I hope it gets approved and helps the people that have not gone through chemo yet, as stated in the article.
geuis 14y ago
Story is a bit light on details. Can anyone provide links to the study and the rationale behind ending it early?
- notatoad 14y ago
  according to the commenters on reddit, the rationale behind ending it early is that this is how clinical trials work. A trial is run until it is statistically clear that a drug is either better or worse than the current market leader it is being compared against. The trial might be ending earlier than expected, but it is not being cut short. The success metrics were reached.
  - refurb 14y ago
    Clinical trials are monitors by IRBs (institutional review boards) that independently monitor the trial to ensure that it is being conducted ethically. It's not odd at all for a trial to be ended early if the drug being tested is obviously better than the control arm. It's especially true in trials that are testing drugs for potentially lethal diseases like prostate cancer. What likely happened was that an interim data review was conducted, the results showed that the new drug was substantially better than the control arm (and statistically significant) and the IRB and sponsoring company decided that it had an ethical obligation to end the trial and provide the drug to all the patients.
  - khuey 14y ago
    It's more complicated than that. http://newsblog.mayoclinic.org/2010/03/19/study-on-stopping-clinical-trials/ http://newsblog.mayoclinic.org/2010/03/19/study-on-stopping-... http://sciencelife.uchospitals.edu/2010/04/19/when-clinical-trials-go-too-well/ http://sciencelife.uchospitals.edu/2010/04/19/when-clinical-...
- ceejayoz 14y ago
  Essentially, it appears to work so well the review board feels it's unethical to withhold the treatment from the control group.
RexRollman 14y ago
Let's hope that this drug works as well for everyone as described in the article.
tshtf 14y ago
Apparently this drug[1] was discovered at non-profit Cancer Research UK[2], not a drug company. 1. https://en.wikipedia.org/wiki/Abiraterone https://en.wikipedia.org/wiki/Abiraterone 2. https://en.wikipedia.org/wiki/Cancer_Research_UK https://en.wikipedia.org/wiki/Cancer_Research_UK
- mrkmcknz 14y ago
  Johnson & Johnson own the rights to this drug they purchased it sometime ago I believe.
  - ars 14y ago
    Yah, it was discovered in 1990, and goes off patent in 2 years.
  - pbhjpbhj 14y ago
    The Wikipedia article for https://en.wikipedia.org/wiki/Abiraterone https://en.wikipedia.org/wiki/Abiraterone says that they acquired the license to produce the drug based on acquisition of a licensee. If true then they have licensed a right rather than owning "the rights". Possibly J&J "invented" a novel therapeutic use for the drug and so gained a further patent? As charities are required to open their accounts in the UK then presumably the amount the licensee paid to Cancer Research UK is part of the public record. It would be interesting to read the terms and the fee involved; presumable Cancer Research would only give an exclusive license for a very generous consideration otherwise they might be in the position of being locking up a useful drug that was paid for by charitable giving and presumably that would be so contrary to their principles. I wonder if they have an SPC in the UK?
- refurb 14y ago
  And I'll bet that some of the research that resulted in the drug being discovered by Cancer Research was not conducted by Cancer Research UK. And I'll bet that Cancer Research UK never could have taken the drug to market because they didn't have the expertise to do so. That's the nature of science, no one person ever discovers a drug independently. All new science is build on the basis of old science.
domwood 14y ago
As someone who's grandfather and grandmother both died of cancer-related complications (edit: in the last four months, my grandmother not even a week ago) and with a grandfather-in-law who has terminal cancer, for once I'm going to abandon cynicism, gloss over the lack of scientific details, and dare to hope.
- tsotha 14y ago
  Don't go overboard. This drug works by suppressing the ability of cancer cells to produce testosterone, which prostate cancer cells need to grow. So it isn't effective against any other type of cancer. Also, I would bet my last dollar the cancer will eventually find a way around it since cancer cells mutate like crazy. So it's probably a question of adding some time to the patient's life instead of curing or even controlling the disease. And there are side effects. Don't get me wrong - if I have terminal prostate cancer I'm gonna pop these pills like candy. But it's only going to help men with aggressive prostate cancer that can't be cured with surgery because it's already metastasized.
  - domwood 14y ago
    No, it's no wonder drug, it's not a cure, it's a treatment. Yes, it probably will become redundant eventually, but as cancer's a genetic thing, it'll be on a patient by patient basis, that means even if a patient's cancer start to develop an immunity to the drug, it'll take a very long time for that immunity to be spread by reproduction, especially as people tend to get cancer after having children (it's far more common in later life after all, or don't have them after they are diagnosed. That means that it'll be useful for a long period of time for the majority of people. In the meantime, that gives science a chance to continue to develop the "next step", whatever that may be. And it's not the only drug of its kind, we've got to the point of being able to target individual cancers, so perhaps the research from this will have uses elsewhere. P.S. I'm not going overboard, cancer has done a damned good job of rampaging through my family, so I think I'm excused a little drama ;)
    - tsotha 14y ago
ck2 14y ago
Now let's hope people in the USA without insurance can afford it. It certainly will be a lucrative, profit-making drug and the temptation will be high to milk it for all it's worth.
- tsotha 14y ago
  If by that you mean the drug company needs to recover development costs plus enough to cover drugs that never made it to market, then... yeah.
  - ck2 14y ago
    Right, just like they charge a fraction of the price outside the USA vs pumping insurance for all it's worth in the USA. After all, the cancer market is so small, only one third of the entire population has cancer at any given time, it might take them more than a year to start making net profit. Please stop defending and apologizing for billionaires.
    - tsotha 14y ago
      >Right, just like they charge a fraction of the price outside the USA vs pumping insurance for all it's worth in the USA. This US is where they recover their development costs. People in poor countries just can't afford to pay what it costs to develop a drug, and the US has only so much influence when it comes to drug patents. Witness India's abrogation of patents on AIDS drugs. When you're Pfizer and Canada tells you "this is what we're willing to pay for your drug. If you don't don't like it we'll just invalidate your patent and give you nothing" you take what you can get. >After all, the cancer market is so small, only one third of the entire population has cancer at any given time, it might take them more than a year to start making net profit. A third of the population has cancer? Not even close. Cancer prevalence in the US is something like 12 million people, http://www.cancer.org/Cancer/CancerBasics/cancer-prevalence http://www.cancer.org/Cancer/CancerBasics/cancer-prevalence out of a population of about 314 million, which works out to something less than a 4%. And there is no "cancer market". Cancer is a class of diseases. This drug is specifically designed to treat prostate cancer (which is itself not one disease but a class of different types of cancers that start in the prostate) that has metastasized, which isn't even most prostate cancer patients. So no, this isn't Lipitor or the next big allergy medication. They're not going to sell this to very many people, and the people who take it are very sick, so most of them won't be taking it for very long. >Please stop defending and apologizing for billionaires. Name one person who made a billion dollars in legal pharmaceuticals. Hell, I wish people were making billions from drugs like this one instead of adding "time release" to drugs that have been on the market forever.
losvedir 14y ago
Ah, yes, abiraterone. In another life, when I did equity research, we covered Cougar Biotech (the owners of the drug before JNJ). Even then (years ago), it was clear this would be a successful drug. Glad to hear science and drug development are moving forward!
- lonnyk 14y ago
  Please elaborate on what made it clear so long ago.
  - losvedir 14y ago
    It did very well in all its trials. To get approved for use in any indication a drug has to go through a number of clinical trials - a Phase 2 in a small group of patients and multiple Phase 3's in a larger group. And that's for one indication only. So a cancer drug might try to get approved for "4th line" use in some cancer, meaning the FDA says it's okay to use after 3 other drugs have failed. After some success there, the drug company might push to expand its label into 3rd line or front line treatment and sponsor more clinical trials to compare it to the drugs currently used at those times. I don't know what trial this article was talking about specifically, but there were a number of other trials abiraterone did spectacularly in beforehand. Unfortunately, I don't recall the specific data from years ago when I kept up with this stuff. Cancer drugs frequently "work", but just barely, stopping the progression of symptoms for a few months or so, and this is enough to get approved. On the other hand, you have Gleevec[1], which turned a certain variety of leukemia from invariably fatal to a death rate of just 1%. Its efficacy was noted early in the trials and got approved quickly. Similarly, abiraterone's efficacy showed clearly in the early trials, although it's somewhere in the middle of the spectrum between "barely efficacious" and Gleevec. [1] https://en.wikipedia.org/wiki/Imatinib https://en.wikipedia.org/wiki/Imatinib
mathattack 14y ago
Great news! For better or worse, there's a lot of benefit from rich people dedicating their lives to beating drugs like this. In a perverse way, Mike Milliken getting prostate cancer was one of the best things for beating this cancer.

149 points by joeyespo 14y ago

This has interesting implications to the recent discussions about A/B testing and Multi-armed bandit algorithms. Assuming double blind tests are akin to A/B testing, at what point was the trial stopped? Was it stopped before there was statistical significance? Or, are there differences in how double blind tests are done than how A/B testing is done in software and websites?

deleted 14y ago
[deleted]
- refurb 14y ago
  What do you mean by triple blinded? The research was double-blinded, what more are you looking for?
  - deleted 14y ago
    [deleted]
  - saurik 14y ago
    http://medical-dictionary.thefreedictionary.com/_/dict.aspx?word=triple+blind http://medical-dictionary.thefreedictionary.com/_/dict.aspx?...
    - refurb 14y ago
      OK, but what makes you think this wasn't triple-blinded? I've never heard a clinical trial called that, but usually the data analysts don't know which patients got the drug either.
planetguy 14y ago
at what point was the trial stopped? Was it stopped before there was statistical significance? I'm guessing... no. I'm guessing they don't call off a zillion-dollar phase III clinical cancer drug trial without running it by someone who has glanced at an undergrad statistics textbook. We're not just banging rocks together here, guys, we know how to do clinical trials.
- DanBC2 14y ago
  > We're not just banging rocks together here, guys, we know how to do clinical trials. There are many problems with clinical trials. Read Ben Goldacre for examples. One problem is that good results are published, while bad results (when they're submitted, which isn't often) are too boring for publication. And then there are all the other problems of studies that aren't correctly blinded, or the selection is faulty, or etc. These are all reputable pharma companies with substantial funds to run tests. I am, obviously, addressing your comment because there's not nearly enough detail in the article to discuss.
  - refurb 14y ago
    Often bad clinical trial results aren't released because they are bad for reasons other than the drug doesn't work. Also, it's very rare for big pharma companies to screw up a clinical trial. It's much more common in the small biotechs and non-profits. If there is one thing that big pharma companies are good at is drug development (not so much drug research).
    - DanBC2 14y ago
      So a big pharma company like Merck wouldn't use a big publishing company like Elsevier to create fake "medical" journals and publish research? https://www.google.co.uk/search?&q=elseviers+fake+journal+merck https://www.google.co.uk/search?&q=elseviers+fake+journa...
      - streptomycin 14y ago
        What does that have to do with clinical trials? You're not being logically coherent. The FDA isn't going to approve a drug because someone makes a fake journal and publishes some results in it.
jerf 14y ago
We are hearing about this precisely because it is unusual and thus newsworthy. This article is light on the scientific details. Given those things, let's extend them the benefit of the doubt for now and hold the standard (and somewhat tedious) litany of complaints until there's more evidence that they are called for, as exceptional actions in such a tightly regulated domain is reasonably likely to imply exceptional circumstances.
Mvandenbergh 14y ago
No. The effect size was large enough that the statistical significance agreed with the FDA before the start of the study was reached well before the end of the trial. This is not uncommon, and the possibility of ending the trial early will have been decided beforehand. Usually an independent advisory board not affiliated with the FDA or the pharma company will make these decisions - the other parties may not even have known that the results were better than expected until the independent board decided to end the study.
Gatsky 14y ago
I was at the announcement of the trial data by the investigators this morning. The results were also discussed by a statistician not involved with the trial directly. Not sure that hacker news needs an in depth analysis of the trial design and outcome, but anyway... In summary, the trial looked at patients who had incurable prostate cancer that had spread and stopped responding to traditional hormonal treatments. Patients had to have no symptoms to be enrolled on this trial. The trial compared abiraterone, a new type of hormonal treatment plus steroids to just being on steroids alone. The question that the trial was asking can be framed as "Does taking abiraterone prolong the period of time that a patient can be symptom free and their cancer is under control?" That was the primary endpoint. A secondary endpoint was survival, or how long they lived. Built in to the study design was a planned interim analysis of the data. Normally, the investigators are not allowed to just look at the data as it accrues continuously because it creates bias. It is a standard approach to allow one look at the data when say 40% of the expected events (in this case, development of progressive cancer) have occurred. When they did this, the difference between getting the drug and not getting the drug was considered big enough to unblind the trial. This means that everyone finds out if they were getting placebo or the real drug. There are multiple reasons why one may decide to do this. First and foremost is that if the drug really works, it would be unethical to leave people on a placebo for long periods, because it is clear they have an inferior outcome. Stopping early also speeds the time to drug approval and market entry for a given indication. There are somewhat esoteric statistical procedures that can determine at an interim analysis if the accrued data shows a statistically significant difference between groups, which would therefore justify stopping the trial, while adjusting for the impact of repeated testing on the type I error rate (ie the chance of finding an association that doesn't really exist). In this trial, there is no doubt that the primary endpoint was positive and clinically and statistically significant, even with only 40% of people on the trial having had a progression event. So they stopped. The data on whether abiraterone reduces the chance of death are not mature, because not enough of the people on the trial have died yet, so those results will be awaited. Stopping early means that these results may be biased however, because the trial is no longer blinded. This was a large and well done trial, that employed standard statistical practices.
- firebones 14y ago
m104 14y ago
No interesting implications, just the reaffirmation that real significance is more important than statistical significance.

novalis 14y ago

This brings great hope to all affected and I hope it gets approved and helps the people that have not gone through chemo yet, as stated in the article.

geuis 14y ago

Story is a bit light on details. Can anyone provide links to the study and the rationale behind ending it early?

notatoad 14y ago
according to the commenters on reddit, the rationale behind ending it early is that this is how clinical trials work. A trial is run until it is statistically clear that a drug is either better or worse than the current market leader it is being compared against. The trial might be ending earlier than expected, but it is not being cut short. The success metrics were reached.
- refurb 14y ago
  Clinical trials are monitors by IRBs (institutional review boards) that independently monitor the trial to ensure that it is being conducted ethically. It's not odd at all for a trial to be ended early if the drug being tested is obviously better than the control arm. It's especially true in trials that are testing drugs for potentially lethal diseases like prostate cancer. What likely happened was that an interim data review was conducted, the results showed that the new drug was substantially better than the control arm (and statistically significant) and the IRB and sponsoring company decided that it had an ethical obligation to end the trial and provide the drug to all the patients.
- khuey 14y ago
  It's more complicated than that. http://newsblog.mayoclinic.org/2010/03/19/study-on-stopping-clinical-trials/ http://newsblog.mayoclinic.org/2010/03/19/study-on-stopping-... http://sciencelife.uchospitals.edu/2010/04/19/when-clinical-trials-go-too-well/ http://sciencelife.uchospitals.edu/2010/04/19/when-clinical-...
ceejayoz 14y ago
Essentially, it appears to work so well the review board feels it's unethical to withhold the treatment from the control group.

RexRollman 14y ago

Let's hope that this drug works as well for everyone as described in the article.

tshtf 14y ago

Apparently this drug[1] was discovered at non-profit Cancer Research UK[2], not a drug company. 1. https://en.wikipedia.org/wiki/Abiraterone https://en.wikipedia.org/wiki/Abiraterone 2. https://en.wikipedia.org/wiki/Cancer_Research_UK https://en.wikipedia.org/wiki/Cancer_Research_UK

mrkmcknz 14y ago
Johnson & Johnson own the rights to this drug they purchased it sometime ago I believe.
- ars 14y ago
  Yah, it was discovered in 1990, and goes off patent in 2 years.
- pbhjpbhj 14y ago
  The Wikipedia article for https://en.wikipedia.org/wiki/Abiraterone https://en.wikipedia.org/wiki/Abiraterone says that they acquired the license to produce the drug based on acquisition of a licensee. If true then they have licensed a right rather than owning "the rights". Possibly J&J "invented" a novel therapeutic use for the drug and so gained a further patent? As charities are required to open their accounts in the UK then presumably the amount the licensee paid to Cancer Research UK is part of the public record. It would be interesting to read the terms and the fee involved; presumable Cancer Research would only give an exclusive license for a very generous consideration otherwise they might be in the position of being locking up a useful drug that was paid for by charitable giving and presumably that would be so contrary to their principles. I wonder if they have an SPC in the UK?
refurb 14y ago
And I'll bet that some of the research that resulted in the drug being discovered by Cancer Research was not conducted by Cancer Research UK. And I'll bet that Cancer Research UK never could have taken the drug to market because they didn't have the expertise to do so. That's the nature of science, no one person ever discovers a drug independently. All new science is build on the basis of old science.

domwood 14y ago

As someone who's grandfather and grandmother both died of cancer-related complications (edit: in the last four months, my grandmother not even a week ago) and with a grandfather-in-law who has terminal cancer, for once I'm going to abandon cynicism, gloss over the lack of scientific details, and dare to hope.

tsotha 14y ago
Don't go overboard. This drug works by suppressing the ability of cancer cells to produce testosterone, which prostate cancer cells need to grow. So it isn't effective against any other type of cancer. Also, I would bet my last dollar the cancer will eventually find a way around it since cancer cells mutate like crazy. So it's probably a question of adding some time to the patient's life instead of curing or even controlling the disease. And there are side effects. Don't get me wrong - if I have terminal prostate cancer I'm gonna pop these pills like candy. But it's only going to help men with aggressive prostate cancer that can't be cured with surgery because it's already metastasized.
- domwood 14y ago
  No, it's no wonder drug, it's not a cure, it's a treatment. Yes, it probably will become redundant eventually, but as cancer's a genetic thing, it'll be on a patient by patient basis, that means even if a patient's cancer start to develop an immunity to the drug, it'll take a very long time for that immunity to be spread by reproduction, especially as people tend to get cancer after having children (it's far more common in later life after all, or don't have them after they are diagnosed. That means that it'll be useful for a long period of time for the majority of people. In the meantime, that gives science a chance to continue to develop the "next step", whatever that may be. And it's not the only drug of its kind, we've got to the point of being able to target individual cancers, so perhaps the research from this will have uses elsewhere. P.S. I'm not going overboard, cancer has done a damned good job of rampaging through my family, so I think I'm excused a little drama ;)
  - tsotha 14y ago

ck2 14y ago

Now let's hope people in the USA without insurance can afford it. It certainly will be a lucrative, profit-making drug and the temptation will be high to milk it for all it's worth.

tsotha 14y ago
If by that you mean the drug company needs to recover development costs plus enough to cover drugs that never made it to market, then... yeah.
- ck2 14y ago
  Right, just like they charge a fraction of the price outside the USA vs pumping insurance for all it's worth in the USA. After all, the cancer market is so small, only one third of the entire population has cancer at any given time, it might take them more than a year to start making net profit. Please stop defending and apologizing for billionaires.
  - tsotha 14y ago
    >Right, just like they charge a fraction of the price outside the USA vs pumping insurance for all it's worth in the USA. This US is where they recover their development costs. People in poor countries just can't afford to pay what it costs to develop a drug, and the US has only so much influence when it comes to drug patents. Witness India's abrogation of patents on AIDS drugs. When you're Pfizer and Canada tells you "this is what we're willing to pay for your drug. If you don't don't like it we'll just invalidate your patent and give you nothing" you take what you can get. >After all, the cancer market is so small, only one third of the entire population has cancer at any given time, it might take them more than a year to start making net profit. A third of the population has cancer? Not even close. Cancer prevalence in the US is something like 12 million people, http://www.cancer.org/Cancer/CancerBasics/cancer-prevalence http://www.cancer.org/Cancer/CancerBasics/cancer-prevalence out of a population of about 314 million, which works out to something less than a 4%. And there is no "cancer market". Cancer is a class of diseases. This drug is specifically designed to treat prostate cancer (which is itself not one disease but a class of different types of cancers that start in the prostate) that has metastasized, which isn't even most prostate cancer patients. So no, this isn't Lipitor or the next big allergy medication. They're not going to sell this to very many people, and the people who take it are very sick, so most of them won't be taking it for very long. >Please stop defending and apologizing for billionaires. Name one person who made a billion dollars in legal pharmaceuticals. Hell, I wish people were making billions from drugs like this one instead of adding "time release" to drugs that have been on the market forever.

losvedir 14y ago

Ah, yes, abiraterone. In another life, when I did equity research, we covered Cougar Biotech (the owners of the drug before JNJ). Even then (years ago), it was clear this would be a successful drug. Glad to hear science and drug development are moving forward!

lonnyk 14y ago
Please elaborate on what made it clear so long ago.
- losvedir 14y ago
  It did very well in all its trials. To get approved for use in any indication a drug has to go through a number of clinical trials - a Phase 2 in a small group of patients and multiple Phase 3's in a larger group. And that's for one indication only. So a cancer drug might try to get approved for "4th line" use in some cancer, meaning the FDA says it's okay to use after 3 other drugs have failed. After some success there, the drug company might push to expand its label into 3rd line or front line treatment and sponsor more clinical trials to compare it to the drugs currently used at those times. I don't know what trial this article was talking about specifically, but there were a number of other trials abiraterone did spectacularly in beforehand. Unfortunately, I don't recall the specific data from years ago when I kept up with this stuff. Cancer drugs frequently "work", but just barely, stopping the progression of symptoms for a few months or so, and this is enough to get approved. On the other hand, you have Gleevec[1], which turned a certain variety of leukemia from invariably fatal to a death rate of just 1%. Its efficacy was noted early in the trials and got approved quickly. Similarly, abiraterone's efficacy showed clearly in the early trials, although it's somewhere in the middle of the spectrum between "barely efficacious" and Gleevec. [1] https://en.wikipedia.org/wiki/Imatinib https://en.wikipedia.org/wiki/Imatinib

mathattack 14y ago

Great news! For better or worse, there's a lot of benefit from rich people dedicating their lives to beating drugs like this. In a perverse way, Mike Milliken getting prostate cancer was one of the best things for beating this cancer.