The position against the House version of the FDA reform bill, which is labeled 'unofficial,' centers on three concerns - the FDA and NIH wouldn’t be able to validate the accuracy of the trial results posted; results data is too technical, and lay summaries may have too much bias, according to
Consumers Union. White House opposition was first reported by
Inside Health Policy (subscription required).
Both House and Senate FDA reform bills require that drug trials are publicly registered, but the House bill would require a public technical trial results database, as well a lay summary of a drug trials, on the Internet. The Senate bill only calls for a study on how to create such a results registry, and gives the FDA 2-1/2 years to make it happen. A final version of the Food and Drug Administration Revitalization Act is being negotiated.
The White House position - official or unofficial - is in line, as it so happens, with PhRMA's position. And there is one problem with this view - failing to make trial results public would allow drugmakers to hide safety problems. Drugmakers may be worried that results can be misinterpreted, but after several years filled with controversies over safety data - antidepressants, Vioxx, Avandia, Ketek, Trasylol, to name a few - industry brought the congressional push for a public database on itself.
“If this is truly the administration’s position, it’s shocking,†said Bill Vaughan, senior health policy analyst with Consumers Union. “At a time when parents can’t even trust their kids’ toys to be safe, it doesn’t make sense the White House would oppose legislation to help make prescription drugs safer.â€
"White House opposition to this aspect of the FDA reform bill is in line with its general approach to open government, which is to say, it opposes it," writes Merrill Goozner in GoozNews, adding that the NIH's Library of Medicine database links to scores of articles not yet validated by peer review. "But disclosure of clinical trial results data is crucial if independent researchers are going to be able to conduct meta-analyses of problematic drugs."
19 Comments
Why does this not surprise me.
"The White House position - official or unofficial - is in line, as it so happens, with PhRMA’s position. And there is one problem with this view - failing to make trial results public would allow drugmakers to hide safety problems"
Big surprise that the White House has the same position as Pharma......The whole point of a clinical trial registry is to get ALL the data out there. That is the ONLY way to get complete and unbiased information.
Politics, n. Strife of interests masquerading as a contest of principles. - Ambrose Bierce
The one problem with mandatory disclosure is that it changes the risk/benefit of conducting the trial, and thus will impact not only which trials are conducted but also the design of the clinical trial. For example, why would you conduct a safety trial or a head to head trial if you have a chance of not being successful? Why would you want to jeopardize your market potential?
Lori,
"Why would you want to jeopardize your market potential?"
PATIENT SAFETY..Maybe
Didnt see the logic in that one...
Lori, that's exactly the point. Accountability is something that they don't want. Market potential should not be the priority..safety and efficacy are..
I think Lori's point is important - it is a key reason why the industry has resisted _anyone_ doing head-to-head trials that they can't entirely control.
While it takes us a bit beyond topic, that is also why many have argued that public agencies need to be funded to perform exactly such trials. The industry, indeed, has little or no incentive to do it unless they can set things up (by jiggering doses, comparator drug, inclusion criteria, etc.) to virtually guarantee their own product will come out on top.
Having "access" to such data, under such circumstances, doesn't provide much (beyond further examples of how easy it is to control results before you have them).
You seem to be assuming that clinical trials are required (beyond pivotal trials required for approval) and that all trials are designed the same. Do you really think that clinical trials are done to objectively assess drug safety? These trials are typically conducted to enhance market potential, and to demonstrate BETTER or EQUIVALENT safety and efficacy.
I happen to believe in full disclosure. My point is that full disclosure is not necessarily the answer, as pharmaceutical companies will then either 1) not conduct any risky trials or 2) design the trials such that any risk and therefore any potential negative result is minimized (e.g. low sample size, selection of endpoints, limiting the eligible patient population, etc). One option to address this problem would be for the FDA (or other third party) to have the authority to mandate conducting specific clinical trials and to have control over their design, in conjunction with full disclosure. Unfortunately, that will never happen.
An addendum - But in case anyone hasn't heard the industry's usually stated reasons for opposing, or limiting, posting of studies:
1. Will "scare" patients before results are really in. Will lead to "deadly overwarning." Essentially, the same argument being used to remove black box from SSRIS.
2. Implicit in above, regular folks are too dumb to understand the what "study" means. This the same argument as pro-preemption. Regular folks are too dumb to be on juries to decide whether a company covered up red flags, etc..
3. Especially for registries - companies A will know what company B is looking at, and will get to the secret potion first. Trade secrets. (It occurs to be that this could be solved by naming all experimental drugs like we do hurricanes. Rather than fancy letters and numbers - compound A326Z7 - we could just say Merck is testing "Hugo."
Lori and I on same page.
If you notice the language of these proposals, it is typically for disclosure of all trials not currently completed or those started after a certain date. What I think would be of immense interest is to require pharmaceutical companies to fully disclose all EXISTING clinical trials and their results, i.e. those trials conducted prior to knowing that the results might have to be disclosed. Lots of completed studies never see the light of day, in part because the results are not favorable.
Hank, I think we're all on the same page, just expressing it differently.
I'm not arguing against transparency, but let's face it, 99% of folks, including the news media, do not have the capability to understand trial results. Experts in various specialties spar over results, typically with multiple interpretations of the same study. We can't and shouldn't expect the average high school or college graduate to understand these results. I have little doubt that transparency, while overall a good thing, will end up cuasing significant harm as the new media whips itself into a frenzy over meaningless or near meaningless study results.
Lori. Excellent points! With Antipsychotics being prescribed at an alarming rate to infants,toddlers and teens,you would think that FDA and Congress would compel the Industry to disclose the clinical trial data they already have completed,but keep it sealed away from public scrutiny.
Atlex, "Folks including the news media,do not have the capability to understand trial results"
Please speak for yourself!! And as far as the Media is concerned,many of the Reporters are highly INTELLIGENT.The Industry understands this.
I can understand the desire to implement mandatory disclosure rules. I don't necessarily oppose this requirement. However, in addition to some of the challenges already mentioned that mandatory disclosure brings:
1. The proposals I've heard about require publication of results within one year. However, it can take longer than one year to publish, especially if the investigators submit the results to a couple journals that reject the article after a long review. If the law then requires industry to disclose these results on a website, then many journals will no longer consider the data for publication since it was already published.
2. It will complicate collaborations between industry and academia, since academics will not face this requirement, but are instead encouraged to pursue the most high profile publications possible.
3. Although many in the media do there job with a mind towards fairness and balance, dramatic negative results sell best. So, IMO, the media does fixate on negative safety data and can ignore positive efficacy data.
Altex, you state:
Experts in various specialties spar over results, typically with multiple interpretations of the same study. We can’t and shouldn’t expect the average high school or college graduate to understand these results.
So, if the experts can take diametrically opposed views after "studying" the data--applying their own metrics and interpretation--how can the "average" high school graduate miss the mark? He will obviously be no more right or wrong than some leading expert.
I guess I'm a little confused. PhRMA began hosting clinicalstudyresults.org in 2004, in which companies reported results on any study not published (or submitted within the year of study end), with companies backfilling results to studies completed as of October 2002.
Granted, this is different than the FDA hosting one, but I think it's quite misleading of consumersunion.org to say that the pharmaceutical industry isn't/doesn't want to disclose results.
Moreover, from the article, it seems that the administration isn't opposed to an FDA database, but rather, are opposed to the 2 areas mentioned in the bill: the FDA can't confirm the accuracy, and that the lay summaries may be biased.
In examining the concerns of the WH:
1. the FDA and NIH wouldn’t be able to validate the accuracy of the trial results posted.
Why not? They can verify who submits AE reports. NIH has a login process for companies submitting grants. You can track IP addresses. FDA investigators can obtain documentation. If you know who is posting the data, and there is ever a questions about the accuracy, you can go back to the source.
2. results data is too technical.
So what? Don't insult my intelligence by keeping information away from me. There are plenty of smart people who can understand data, and people who can explain data to those who can't interpret the primary source. If those interpreters oversimplify, manipulate or lie about the data, other smart people will point it out. It happens all the time--notably when Nissen applied a meta-analysis that may have been inappropriate. 3. and lay summaries may have too much bias.
Again I say, so what? If you release the primary data, there are enough people who will catch such biases and expose them.
The last thing I need is the government protecting me from myself, whether it benefits the drug companies (such as in this case), or harms them (such as the Provenge debate).
And for the drug companies to take this stand certainly undermines the image they want to cultivate of having patients' best interests at heart.
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