6 ms·

Europe votes for clinical trial transparency

108 points by oyvindeh 12y ago

fit2rule 12y ago
This is great news - no more pharmaceutical profit projects getting pushed to the forefront, only to discover a few years later that the adverse affects were buried in 'company proprietary confidental' reports .. makes it safer to live in Europe!
- refurb 12y ago
  The EMA should work on discovering the drugs that already have publically reported serious side effects. It took the EMA how long to pull Mediator?
  - fit2rule 12y ago
    Corruption also happens in Europe, friend! Big steps, one step at a time.
arethuza 12y ago
Both "Bad Pharma" and "Bad Science" are excellent books - strongly recommended: http://en.wikipedia.org/wiki/Bad_Pharma http://en.wikipedia.org/wiki/Bad_Pharma http://en.wikipedia.org/wiki/Bad_Science_%28book%29 http://en.wikipedia.org/wiki/Bad_Science_%28book%29 I wonder if you can get "I am a Nutritionist!" T-shirts? [Edit: Thanks for pointing out the T-Shirt pretty much does exist].
- JonnieCache 12y ago
  He sells shirts picturing a rubber ducky with "nutritionist" printed underneath: http://badscience2.spreadshirt.co.uk/sophisticated-visual-gag-A18169393/customize/color/1 http://badscience2.spreadshirt.co.uk/sophisticated-visual-ga... Congrats to ben goldacre and everyone else who worked on this!
  - deleted 12y ago
    [deleted]
ekianjo 12y ago
> • Require that a summary understandable to a lay person of what was found in the trial is published on the register. Good luck with that. Explaining complex cellular mechanisms to a lay person without any scientific nor statistical background is a very difficult task. When you consider modern medicine, you need basic knowledge in genetics, biochemistry, biology, proteins, drug formulation, pharmacology, pharmadynamics, toxicity, clinical studies design, to have a proper understanding of what a study means. We're not talking about aspirin class of medicines anymore, and more and more drugs are now in the class of large molecules.
- arethuza 12y ago
  It might not be possible in every case, but it sounds like a laudable goal to me. Also, what do they tell people who take part in trials - I'd be pretty annoyed if I took part in a trial and someone told me "we can't tell you because with your humble CS education you wouldn't understand it".
  - ekianjo 12y ago
    People who take part in trials usually dont care about the science, they take part in it because all the other treatments failed and they are willing to try something new. That's their main incentive, at least for life threatening diseases.
    - arethuza 12y ago
      What percentage of clinical trials involve people in those kinds of situations?
      - ekianjo 12y ago
        All oncology trials. And thats already A LOT.
        arethuza 12y ago
sveme 12y ago
Getting all the information from all clinical trials will probably spur some great data mining efforts, on a much broader scale than what has been done so far. For example, a former colleague of mine used the correlation of published drug side effects between different drugs [1] to predict potential alternative therapeutic targets. Getting all the data on drug efficacy, availability, correlate it with chemical structure, combine it with the information on other drugs could potentially help us a lot in predicting better working future drugs and the workings of existing drugs. Also, transparency. No more picking out those trials that worked and conveniently forgetting about those that did not work. [1] https://www.sciencemag.org/content/321/5886/263.abstract https://www.sciencemag.org/content/321/5886/263.abstract
srean 12y ago
As far as I know, US laws require that the `x` number of trials demonstrate the effectiveness of the drug and failured dont need to be reported. But this does not make sense to me, and I welcome the European laws. In the US system, even if I have a coin biased badly against coming up heads, if I toss it enough number of times I will get `x` heads. The tosses cost money and that is then used to justify the patent system. One of the oft repeated justification for the absurd levels of IP protection and patent extensions that pharma enjoys is the huge cost of trials. But if huge development costs are the reason for these protections to exist, guess what, these costs will continue to remain huge. Its just self perpetuating. Patents are primarily a preemptive measure against a hypothetical scenario. The hypothesis is that unless market pressures are cordoned off, innovation will stop. It is a believable hypothesis but not a quantitative one, and this exactly where we need a quantitative one. How many years exactly does one need to subvert the market so that a satisfactory level of innovation is maintained ? Nobody knows. In these scenario what we need is a feedback system, and pretty much the only scalable and fair apparatus that we have for such feedback on economic affairs is the market. So rather than subverting the market, market should be explicitly and actively involved to work out this trade-off. How exactly this is to be done needs to be worked out. There could be a futures market on patents on drugs undergoing testing: competitors can promise to buy the patent to the (drug,usecase) pair at a particular price (even if its a dud) and if the owner decides not to sell the owner pay a particular compensation. Such measures will spread the risk. There should be mechanisms for a company to raise money for testing in lieu of rights over the product. The initial period of validity of a patent should be short, like 3~6 years, following which the patent is on the market. Entities can bid to bring the patent to public domain. The owner(s) bids to retain it. Whoever wins gets the balance. Of course the "bring it to public domain" bidders will bid less because profitability is less when its in the public domain, but market decides who gets to own it. If the owner(s) think they can still extract lots of profit from the drug, bid high. We should stop handing out blank checks without a feedback loop, that is just bad design.
- deleted 12y ago
  [deleted]
- Alex3917 12y ago
  In the US you need two trials showing that a drug is effective, but you can have an unlimited number showing that it's not effective. Also it doesn't need to be shown to be effective against a disease, it can just be effective at reducing some number that correlates with a disease. And you don't need to show that it's effective in the longterm, only for up to 6 weeks - it could make the disease dramatically worse in the longterm, and that's fine even if the drug is meant for longterm use. There are some rules trying to get all new trials registered, but the rules aren't followed at all and the FDA doesn't enforce them.
barking 12y ago
Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.
- pjc50 12y ago
  The EP is actually quite good at producing the right decisions, especially when the public remember that it exists and lobby them over this issue. Unfortunately it's the weakest of the legislating institutions (Parliament/Commission/Council).
  - mercurial 12y ago
    Yes. I'd like to have EU institutions which look more like "normal" democratic systems, and greater power for the EU parliament. But it's still a lot better since the Lisbon treaty.
- peteretep 12y ago
  Another excellent decision made by the MEPs that the general public will simply not give a shit about. Your cynicism is too high. Votes for "tax the right", "throw out the immigrants", "abandon the EU" are popularism. Good science and technology votes stand by themselves.
  - barking 12y ago
    Maybe your right but to my mind there's been a suspiciously high level of superficially praiseworthy pronouncements emanating from Strasbourg just lately. Given the limited powers of the parliament do they carry any more weight than politicians' pre-election promises? I don't know where you live 3 billboards on my way to work are now taken up with advertisements on behalf of our local MEP. She had been all but invisible previously. As I said in a comment lately she has recently been on the radio here claiming credit for another measure that promises much but has been criticised for being easily sidestepped.
- Mvandenbergh 12y ago
  Well, yes, elected politicians doing things their constituents want so that they'll get re-elected is surely the point of the system.
andrewla 12y ago
In the US, this is already present, to some extent, with FDAAA 801 [1], which requires that all clinical trials be registered before they start. Missing things like required publication and the "human-readable" digest, but the absence of data can be factored in by the FDA when considering approval -- that is, studies that terminate without reaching a finding can be considered weak indicators of problems, and in the long run, potentially point to organizations or individuals who might be suppressing negative results. Even required publication is no cure for this; a result saying "we inadvertently broke the blind" or "the protocol was poorly implemented" is perfectly possible even in good faith. [1] http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa
switch007 12y ago
For God's sake, another article that conflates Europe and the EU! Lazy, lazy journalism.

108 points by oyvindeh 12y ago

This is great news - no more pharmaceutical profit projects getting pushed to the forefront, only to discover a few years later that the adverse affects were buried in 'company proprietary confidental' reports .. makes it safer to live in Europe!

refurb 12y ago
The EMA should work on discovering the drugs that already have publically reported serious side effects. It took the EMA how long to pull Mediator?
- fit2rule 12y ago
  Corruption also happens in Europe, friend! Big steps, one step at a time.

arethuza 12y ago

Both "Bad Pharma" and "Bad Science" are excellent books - strongly recommended: http://en.wikipedia.org/wiki/Bad_Pharma http://en.wikipedia.org/wiki/Bad_Pharma http://en.wikipedia.org/wiki/Bad_Science_%28book%29 http://en.wikipedia.org/wiki/Bad_Science_%28book%29 I wonder if you can get "I am a Nutritionist!" T-shirts? [Edit: Thanks for pointing out the T-Shirt pretty much does exist].

JonnieCache 12y ago
He sells shirts picturing a rubber ducky with "nutritionist" printed underneath: http://badscience2.spreadshirt.co.uk/sophisticated-visual-gag-A18169393/customize/color/1 http://badscience2.spreadshirt.co.uk/sophisticated-visual-ga... Congrats to ben goldacre and everyone else who worked on this!
- deleted 12y ago
  [deleted]

ekianjo 12y ago

> • Require that a summary understandable to a lay person of what was found in the trial is published on the register. Good luck with that. Explaining complex cellular mechanisms to a lay person without any scientific nor statistical background is a very difficult task. When you consider modern medicine, you need basic knowledge in genetics, biochemistry, biology, proteins, drug formulation, pharmacology, pharmadynamics, toxicity, clinical studies design, to have a proper understanding of what a study means. We're not talking about aspirin class of medicines anymore, and more and more drugs are now in the class of large molecules.

arethuza 12y ago
It might not be possible in every case, but it sounds like a laudable goal to me. Also, what do they tell people who take part in trials - I'd be pretty annoyed if I took part in a trial and someone told me "we can't tell you because with your humble CS education you wouldn't understand it".
- ekianjo 12y ago
  People who take part in trials usually dont care about the science, they take part in it because all the other treatments failed and they are willing to try something new. That's their main incentive, at least for life threatening diseases.
  - arethuza 12y ago
    What percentage of clinical trials involve people in those kinds of situations?
    - ekianjo 12y ago
      All oncology trials. And thats already A LOT.
      - arethuza 12y ago

sveme 12y ago

Getting all the information from all clinical trials will probably spur some great data mining efforts, on a much broader scale than what has been done so far. For example, a former colleague of mine used the correlation of published drug side effects between different drugs [1] to predict potential alternative therapeutic targets. Getting all the data on drug efficacy, availability, correlate it with chemical structure, combine it with the information on other drugs could potentially help us a lot in predicting better working future drugs and the workings of existing drugs. Also, transparency. No more picking out those trials that worked and conveniently forgetting about those that did not work. [1] https://www.sciencemag.org/content/321/5886/263.abstract https://www.sciencemag.org/content/321/5886/263.abstract

srean 12y ago

As far as I know, US laws require that the `x` number of trials demonstrate the effectiveness of the drug and failured dont need to be reported. But this does not make sense to me, and I welcome the European laws. In the US system, even if I have a coin biased badly against coming up heads, if I toss it enough number of times I will get `x` heads. The tosses cost money and that is then used to justify the patent system. One of the oft repeated justification for the absurd levels of IP protection and patent extensions that pharma enjoys is the huge cost of trials. But if huge development costs are the reason for these protections to exist, guess what, these costs will continue to remain huge. Its just self perpetuating. Patents are primarily a preemptive measure against a hypothetical scenario. The hypothesis is that unless market pressures are cordoned off, innovation will stop. It is a believable hypothesis but not a quantitative one, and this exactly where we need a quantitative one. How many years exactly does one need to subvert the market so that a satisfactory level of innovation is maintained ? Nobody knows. In these scenario what we need is a feedback system, and pretty much the only scalable and fair apparatus that we have for such feedback on economic affairs is the market. So rather than subverting the market, market should be explicitly and actively involved to work out this trade-off. How exactly this is to be done needs to be worked out. There could be a futures market on patents on drugs undergoing testing: competitors can promise to buy the patent to the (drug,usecase) pair at a particular price (even if its a dud) and if the owner decides not to sell the owner pay a particular compensation. Such measures will spread the risk. There should be mechanisms for a company to raise money for testing in lieu of rights over the product. The initial period of validity of a patent should be short, like 3~6 years, following which the patent is on the market. Entities can bid to bring the patent to public domain. The owner(s) bids to retain it. Whoever wins gets the balance. Of course the "bring it to public domain" bidders will bid less because profitability is less when its in the public domain, but market decides who gets to own it. If the owner(s) think they can still extract lots of profit from the drug, bid high. We should stop handing out blank checks without a feedback loop, that is just bad design.

deleted 12y ago
[deleted]
Alex3917 12y ago
In the US you need two trials showing that a drug is effective, but you can have an unlimited number showing that it's not effective. Also it doesn't need to be shown to be effective against a disease, it can just be effective at reducing some number that correlates with a disease. And you don't need to show that it's effective in the longterm, only for up to 6 weeks - it could make the disease dramatically worse in the longterm, and that's fine even if the drug is meant for longterm use. There are some rules trying to get all new trials registered, but the rules aren't followed at all and the FDA doesn't enforce them.

barking 12y ago

Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.

pjc50 12y ago
The EP is actually quite good at producing the right decisions, especially when the public remember that it exists and lobby them over this issue. Unfortunately it's the weakest of the legislating institutions (Parliament/Commission/Council).
- mercurial 12y ago
  Yes. I'd like to have EU institutions which look more like "normal" democratic systems, and greater power for the EU parliament. But it's still a lot better since the Lisbon treaty.
peteretep 12y ago
Another excellent decision made by the MEPs that the general public will simply not give a shit about. Your cynicism is too high. Votes for "tax the right", "throw out the immigrants", "abandon the EU" are popularism. Good science and technology votes stand by themselves.
- barking 12y ago
  Maybe your right but to my mind there's been a suspiciously high level of superficially praiseworthy pronouncements emanating from Strasbourg just lately. Given the limited powers of the parliament do they carry any more weight than politicians' pre-election promises? I don't know where you live 3 billboards on my way to work are now taken up with advertisements on behalf of our local MEP. She had been all but invisible previously. As I said in a comment lately she has recently been on the radio here claiming credit for another measure that promises much but has been criticised for being easily sidestepped.
Mvandenbergh 12y ago
Well, yes, elected politicians doing things their constituents want so that they'll get re-elected is surely the point of the system.

andrewla 12y ago

In the US, this is already present, to some extent, with FDAAA 801 [1], which requires that all clinical trials be registered before they start. Missing things like required publication and the "human-readable" digest, but the absence of data can be factored in by the FDA when considering approval -- that is, studies that terminate without reaching a finding can be considered weak indicators of problems, and in the long run, potentially point to organizations or individuals who might be suppressing negative results. Even required publication is no cure for this; a result saying "we inadvertently broke the blind" or "the protocol was poorly implemented" is perfectly possible even in good faith. [1] http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa

switch007 12y ago

For God's sake, another article that conflates Europe and the EU! Lazy, lazy journalism.