On the eve of congressional negotiations to pass an FDA reform bill, we asked you whether the legislation should include a provision requiring drugmakers to post their results on the Internet as part of a proposed database. The idea is controversial because drugmakers worry about competitive snooping, while those outside industry fear safety issues may be hidden.
Nonetheless, the overwhelming majority of you voted in favor of disclosure. One caveat: this isn't a scientific poll. Moreover, judging by the outcome, it would appear many industry people sat this one out. Perhaps, those of you who work for drugmakers recognized this was a losing cause? Or perhaps, as some readers wrote in to remind us, many pharma employees agree. The House yesterday passed a bill that requires such a database, although the level of disclosure needs to be determined. The Senate must now vote.
Should there be a complete public trials database on the Internet?
Yes - 1,681, or 99 percent; No - 19, or 1 percent.
Total Voters: 1,700*
* - We updated the final tally on Sept. 23, because the results were posted a few hours before the poll actually closed and another 214 votes were cast. We did so because the Senate was set to vote on the legislation and we wanted lawmakers and their staffs to know what people were thinking. We would like to point out that the additional votes didn't change the percentages in favor or against.
7 Comments
Perhaps those in the pharmaceutical industry voted their personal feelings as consumers, rather than representing their companies.
Maybe industry people sat it out because they know that such a database ALREADY EXISTS (i.e., www.clinicalstudyresults.org)? Boy, I'm sounding like a broken record, but no one seems to want to acknowledge that this has been going on since 2004.
As I said previously, having only read the blurbs about the proposed FDA database (and not the text of the bill), I fail to see what the FDA database adds to what already exists.
As for the snooping aspect, I think that only really applies to investigational prodcuts, and I think drug companies have every right to keep that data confidential until the drug is approved/marketed. Even for investigational compounds, serious safety issues have to/will be reported -- early phase trials are stopped all the time for safety reasons, sometimes with substantial coverage.
Somewhat tangential to Lori's comment, isn't it possible that Pharma folks also value transparency and disclosure? And that's regardless of consumer vs. commercial interests. The 2 ARE NOT mutually exclusive. Let's please not paint all Pharma employees with such a broad brush.
Dear Reality,
Understood. And so we've added a line indicating that pharma employees may privately agree and voted that way. Thanks to you and Lori for underscoring this point.
ed at Pharmalot
Someone said that there is already a database for this. However, the issue here is the legislation that will require that studies are posted, not whether there is already a place to publish them. The question to ask is: why was there pressure to remove the requirement from the legislatoin, do they have something to hide?
Ed,
Let's not forget that there are plenty of pharma employees who publicly agree as well.
Adam,
The PhRMA database is more than just a place to publish the studies -- it is an agreement by member companies to post results there (http://www.clinicalstudyresults.org/primers/Clinical_Study_Results_Database.pdf). While the PhRMA database is technically voluntary, the companies that I'm familiar with treat posting as mandatory and take it quite seriously.
There will be those in the industry opposed to a mandatory database for any number of reasons, but there are legitimate reasons for opposing certain aspects (e.g., investigational compounds, provisions that posting will not endanger publication in journals, etc.). I have not read the bill, but I know that these were issues with the PhRMA database. That said, I'm sure there are those who have less-than-honorable reasons for not wanting the database, and they are the ones who perpetuate the industry's subversive reputation.