7 ms·

This isn't what "the problem" is. There are lots of problems, but one of the big ones this combats is systematic deliberate fraud. Companies were cherry-picking

by ZoFreX 11y ago

This isn't what "the problem" is. There are lots of problems, but one of the big ones this combats is systematic deliberate fraud. Companies were cherry-picking the trials that got results (and if you run enough trials, some will have results just through chance) in order to get drugs approved that were not any better than placebo. If there is actual data to suggest who the drug works on best, and empirical tests to determine who that is, it can absolutely be tested within those limits and approved for use on that population.

danieltillett 11y ago
The reason the companies are cherry picking the results is they know this basic problem exists. Only drugs that have evidence of working at stage I and II progress to stage III. What happens is the drug companies decide at stage III what patients to let into the trial. What they are trying to avoid is anything that will limit the market size once approved. This means they try to skate as close as they can to the effectiveness limit and still get the drug approved. For example, if they have a new cancer drug that they know only works on cancers with certain mutations, what they will try to do is to test the drug in a broad population of patients including those without the mutation. Since for the approval process it does not really matter how effective the drug is (as long as overall it is statically significant) and that you can only market to the population you tested in, you will want to shove in as many “filler patients" as you think the drug can support. Due to the difficulty of designing large trials they often get the filler number wrong. I don’t condone this activity, but this is the commercial reality. More fundamentally the pharmaceutical industry is being crushed between two very powerful forces - the cost of developing new drugs continues to get more expensive every year (mostly thanks to regulations), while the real market for each drug shrinks as sub-populations are identified for each disease. Combine this with a refusal of society and insurance companies to pay ever increasing drug prices and the outlook for the industry is not great.
- ZoFreX 11y ago
  I've never heard this conspiracy theory before. Have you got some written evidence to hand?
  - danieltillett 11y ago
    This is not a conspiracy theory. Who to include in a stage III trial is one of the most difficult problems facing pharma management. They aim to make these as broad as possible and lots of drugs have died because the stage III trials were made too open. If you want to get a good idea of what really goes on in the pharam industry have a read of the “In The Pipeline” blog [1]. Most of the real value is in the comments. 1. http://blogs.sciencemag.org/pipeline/ http://blogs.sciencemag.org/pipeline/

by ZoFreX 11y ago

danieltillett 11y ago

The reason the companies are cherry picking the results is they know this basic problem exists. Only drugs that have evidence of working at stage I and II progress to stage III. What happens is the drug companies decide at stage III what patients to let into the trial. What they are trying to avoid is anything that will limit the market size once approved. This means they try to skate as close as they can to the effectiveness limit and still get the drug approved. For example, if they have a new cancer drug that they know only works on cancers with certain mutations, what they will try to do is to test the drug in a broad population of patients including those without the mutation. Since for the approval process it does not really matter how effective the drug is (as long as overall it is statically significant) and that you can only market to the population you tested in, you will want to shove in as many “filler patients" as you think the drug can support. Due to the difficulty of designing large trials they often get the filler number wrong. I don’t condone this activity, but this is the commercial reality. More fundamentally the pharmaceutical industry is being crushed between two very powerful forces - the cost of developing new drugs continues to get more expensive every year (mostly thanks to regulations), while the real market for each drug shrinks as sub-populations are identified for each disease. Combine this with a refusal of society and insurance companies to pay ever increasing drug prices and the outlook for the industry is not great.

ZoFreX 11y ago
I've never heard this conspiracy theory before. Have you got some written evidence to hand?
- danieltillett 11y ago
  This is not a conspiracy theory. Who to include in a stage III trial is one of the most difficult problems facing pharma management. They aim to make these as broad as possible and lots of drugs have died because the stage III trials were made too open. If you want to get a good idea of what really goes on in the pharam industry have a read of the “In The Pipeline” blog [1]. Most of the real value is in the comments. 1. http://blogs.sciencemag.org/pipeline/ http://blogs.sciencemag.org/pipeline/