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Europe votes for clinical trial transparency

108 点作者 oyvindeh大约 11 年前

8 条评论

arethuza大约 11 年前
Both &quot;Bad Pharma&quot; and &quot;Bad Science&quot; are <i>excellent</i> books - strongly recommended:<p><a href="http://en.wikipedia.org/wiki/Bad_Pharma" rel="nofollow">http:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Bad_Pharma</a><p><a href="http://en.wikipedia.org/wiki/Bad_Science_%28book%29" rel="nofollow">http:&#x2F;&#x2F;en.wikipedia.org&#x2F;wiki&#x2F;Bad_Science_%28book%29</a><p>I wonder if you can get &quot;I am a Nutritionist!&quot; T-shirts?<p>[Edit: Thanks for pointing out the T-Shirt pretty much does exist].
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sveme大约 11 年前
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.<p>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.<p>Also, transparency. No more picking out those trials that worked and conveniently forgetting about those that did not work.<p>[1] <a href="https://www.sciencemag.org/content/321/5886/263.abstract" rel="nofollow">https:&#x2F;&#x2F;www.sciencemag.org&#x2F;content&#x2F;321&#x2F;5886&#x2F;263.abstract</a>
srean大约 11 年前
As far as I know, US laws require that the <i>`x`</i> 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 <i>`x`</i> heads. The tosses cost money and that is then used to justify the patent system.<p>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.<p>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.<p>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.<p>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.<p>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 &quot;bring it to public domain&quot; 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.
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ekianjo大约 11 年前
&gt; • Require that a summary understandable to a lay person of what was found in the trial is published on the register.<p>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&#x27;re not talking about aspirin class of medicines anymore, and more and more drugs are now in the class of <i>large molecules</i>.
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fit2rule大约 11 年前
This is <i>great</i> 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 &#x27;company proprietary confidental&#x27; reports .. makes it safer to live in Europe!
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andrewla大约 11 年前
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 &quot;human-readable&quot; 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.<p>Even required publication is no cure for this; a result saying &quot;we inadvertently broke the blind&quot; or &quot;the protocol was poorly implemented&quot; is perfectly possible even in good faith.<p>[1] <a href="http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa" rel="nofollow">http:&#x2F;&#x2F;www.clinicaltrials.gov&#x2F;ct2&#x2F;manage-recs&#x2F;fdaaa</a>
switch007大约 11 年前
For God&#x27;s sake, <i>another</i> article that conflates Europe and the EU! Lazy, lazy journalism.
barking大约 11 年前
Another popular decision by our MEPS just in advance of the EU parliament elections this summer.<p>Next comes mom and then apple pie.
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