I’ve heard from several people that they’re not sure exactly what we’re asking Congress to do. Our narrative is long because it coveres many bases. Here’s the short version. We want Congress to mandate that the FDA talk to us directly through clinicaltrials.gov about the clinical trials of FDA regulated drugs. The drug and device manufacturers have created a whole fabulist industry that fills our journals with articles about clinical trials that are often/usually inaccurate and used as marketing tools. Meanwhile the FDA, the only kid on the block that can actually see the data in the raw, watches all of this happening but does nothing. The public interface designed to give us an alternative to these journal articles, the NIH’s clinicaltrials.gov, has withered from disuse atrophy because nobody populates it on time [if at all] or checks up on it.
We’re proposing that Congress give us an alternative to the jury-rigged articles published by industry in our journals. All the pieces to create that alternative system are already in existence. The NIH’s clinicaltrials.gov is a well designed system for telling us what we need to know. The FDA has access to all of the information about the clinical trials on FDA regulated drugs, submitted in applications for approval. If it’s not all there, they can suspend action until they get it. So we are asking Congress to make the NIH clinicaltrials.gov the official interface between the FDA and the physicians/patients who need to know about these clinical trials.
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Create a Protocol that defines the target population, the intervention(s) to be tested, and define the PRIMARY and SECONDARY OUTCOME PARAMETERS and how they will be analyzed BEFORE the study begins.
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Then do the study.
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Perform the a priori defined analyses on the a priori defined PRIMARY and SECONDARY OUTCOME PARAMETERS [a priori means BEFORE anyone gives the first subject the first pill].
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Display the RESULTS.
We want the FDA to actively check that the original REGISTRATION on clinicaltrials.gov is filed before the study starts, that the PRIMARY and SECONDARY OUTCOME PARAMETERS and how they will be analyzed are clearly specified, and that the version on clinicaltrials.gov is the same as the version filed with the FDA [NDA and PMA trials]. We want the FDA to post a notice on clinicaltrials.gov that this has been done.
We want the same thing with the RESULTS. We want the FDA to actively check that the results are posted on clinicaltrials.gov for every trial submitted to the FDA at the time of submission. We want the FDA to insure that those results on clinicaltrials.gov are the same as those in the FDA analysis [the a priori defined analysis of the a priori defined the PRIMARY and SECONDARY OUTCOME PARAMETERS]. We want the FDA to post a notice on clinicaltrials.gov that this has been done.
The sponsors of these clinical trials have so far succeeded in their bizarre claim that the clinical trial data is proprietary. But they can’t claim that that’s true of their version of the results. These are FDA regulated drugs and those results are part of the regulatory process. While the FDA has no jurisdiction over journal articles, if the articles misrepresent the FDA certified results or include other parameters or analyses without clearly annotating them as non-protocol results, the FDA should have the injunction to act [false advertising].
There’s more, but that’s enough. You get the drift. If the sponsors of these trials and the journals they publish in can’t give us accurate scientific reports on these crucial clinical trials, we are petitionong Congress to mandate that the FDA provide it to us – by law. Like many of you, we’re as…
… mad as hell and we’re not going to take it anymore!
2 questions:
1. It is my understanding that the data that pharmaceutical companies provide the FDA is considered proprietary. That the FDA currently does not hold the prerogative to unilaterally reveal that information (or appear to be doing so). My understanding of this is limited, but I believe is viewed as being at least in down way proprietary and I at least would find it helpful if you could provide context for what forms the basis of it being viewed that way. I believe that the legislative and/or executive branch have explicitly excluded that information from the transparency accorded to other information held by the federal government.
If we are to demand thinking outside the box it would seem important to first sufficiently understand the box.
2. There appears to be overlap between the concerns expressed in your petition and the work of the AllTrials USA campaign. The closest that I’ve seen to what you are suggesting were the efforts of the EU Ombudsman with EMA. AllTrials was a major force in relation to those efforts. Laying out who the other players in the US (if any) are in these efforts to impact FDA release of information (a la EMA) would also be helpful. A petition would appear most promising in the context of the infrastructure of a larger campaign. A bit more information around to whom the petition would be presented, and why they would care about the signatures might be helpful. AllTrials appears to have been created with the aim of creating a scaffolding, an infrastructure, for further work. I point to them NOT to say that your goals must be in full agreement, NOR to imply that there are not other niches to fill, but the sea change you propose will require a conflagration of which this petition would seem but a spark (however valunale and laudable a spark it might be). Who is likely to carry this work forward? Who is this meant to galvanize?
Actually, looking more for answers around question #2. Notice that you appear to be asking the FDA to use the proprietary information to assess accuracy of what’s being posted, and comment on lack thereof, rather than to release the information itself. So that might be a workaround. That might address the problem of #1.
I may be wrong about this, but here’s what I think is true. The study data that a pharmaceutical company gives the FDA may well be proprietary-I’m not sure of this. But the study protocol is not. If they’re doing a study, and they’re required to register it on clincialtrials.gov (which they are, even though it’s not enforced), then they have to indicate what they’re studying, and how they’re going to go about studying it, even if they don’t have to provide the individual data points.
Once the study ends, they have results. I don’t know if these can be proprietary. But if they are proprietary, then they shouldn’t be publishing them in peer reviewed journals, and simultaneously not revealing them on clinicaltrials.gov.
I guess you’re working through the existing infrastructure created by the Lown Institute. I guess you’ll be working with them to leverage the petition with a member of Congress. It’s interesting. AllTrisls is starting with a general concept and pursuing supporting various means of instantiation. You’re starting with an extremely specific proposal. It’ll be interesting to see what traction you get and with whom.
It strikes me as bizarre that data on pills that millions of people take, and which can either help or poison them, is considered proprietary. Very recent posts here have pointed out how serious adverse events are markedly under-reported in journal articles. This alone should strip the cloak of proprietary away from the data, as it is so distorted when it is reported to the public.
I can understand how a perfume company’s formulas are proprietary, and thus should be kept secret. But perfume does not kill people, in the way that Vioxx and other pills did. And perfume is a luxury, not something prescribed to frightened, ill, people.
Interesting to read this in parallel:
http://www.alltrials.net/news/fdaaa-2007-scope-compliance-hss-fda-nih/
http://www.alltrials.net/news/new-us-rules-fail-to-impose-full-transparency-on-clinical-trials/
Signed and contributed, many thanks and all the best in taking on this important issue.
This is a good idea, but I think access to raw data could be an Achilles heal.
I’m sure I’ve read from a number of sources that the raw data from PhARMA’s clinical trials are not submitted by drug companies to the FDA – the FDA only gets a summary. As I understand it, the FDA has, on rare occasions, gained access to raw data, but most often not.
I don’t know what hoops the FDA jumps through when they do get raw data, but: 1) The FDA might need a vast amount of additional resources (or changes in the law) to routinely acquire and to analyze raw data. 2) Given that 40 or 50% of the FDA’s drug approval funding is provided by the drug companies themselves, good luck getting PhARMA to pay for staff to keep them honest.
Looks like the Science and Evidence Council of the Lown institute is the sponsor of the petition?
http://rightcarealliance.org/rightcare-alliance-councils/science-and-evidence-council/