The "Clinical Trial Register" as currently constructed is most unlikely to solve the problem. In fact it may provide an appearance of a solution, diverting attention from the real problem. There are several obvious reasons for this, some of which are given by the excellent medical reporter Jeanne Lenzer in her NPR interview of 18 January 2008 (Transcript here).
On the "federal fine for pharma companies who misreport or don't report"
LENZER: Ten thousand dollars, it’s meaningless. Even though some of those fines can accumulate after a certain period of time, they get a 30-day warning period, and at $10,000 a day that’s nothing next to the millions of dollars per day that they pull in. And if the past serves as any kind of information, then what we know is, is that they will ignore these.
Death as a trade secret: On the fact that we already had a Clinical Trial Register - it was called the FDA. Those charged with maintaining that register have colluded to hide inconvenient findings.
LENZER: Yes. There was a research scientist who really had a stricken conscience and called me and said that Congress is looking at whether antidepressants cause suicidality or not. And it’s natural to wonder is it really the drug or is it the underlying depression?
And what this research scientist, who remains anonymous, said to me was because they knew there was a question about suicidality with their pills. What they did in this study was they took healthy test subjects, screened them all to not be depressed and then tested them with this drug that they hoped they would be able to use for urinary incontinence.
And what they found was there was about a doubling of the suicidality among these patients. So that sure seemed like important information to patients who were taking that same drug for depression.
INTERVIEWER: But because the drug was not put on the market as an anti-incontinence product, the rules did not require Lilly to disclose the suicide of an otherwise healthy 19-year-old college student in the midst of a trial in its own laboratory.
LENZER: Exactly. And when I filed a Freedom of Information Act request with the FDA for all of the serious adverse events and deaths of patients taking this drug, and when I got that database back, it did not include her death. And it didn't include the deaths of at least four other patients. They weren't even patients. These were healthy volunteers who were taking the drug as part of a clinical trial.
And I asked the FDA why they hadn't released these deaths, and they said, because they are a trade secret. And they were a trade secret because the drug didn't make it onto the market for that particular use, for incontinence. But it was being used by many patients for depression.
The most important comment of all : On raw data
INTERVIEWER: It seems to me that, you know, there’s a very good solution for this at hand, and that would be a change in the law that would allow the FDA to demand and post on the Internet not only the existence of all clinical trials but the results, and then let it be sorted out by the medical community. But that’s not possible now, is it?
LENZER: You’re right, because right now, under trade secrecy rules, which is what affected the girl that we discussed earlier who committed suicide, her death was considered a trade secret. We need to change things so that anyone’s clinical outcome on a trial should never be a trade secret, and that should be available for scrutiny - and I'd also add not just the results of these trials but the actual underlying raw data. They need to be available to other scientists for scrutiny.
For other comments see Clinical Psychology and Psychiatry : Clinical Trial Registry of WHAT?
Labels: Clinical trials register