Via Twitter, from the Wall Street Journal Health Blog: “The FDA should do a lot more to police potential conflicts of interest among researchers conducting clinical trials of experimental drugs and medical devices, a government watchdog says. Read the report, out today from the office of the Inspector General at the Department of Health and Human Services.” The details are, pardon my extremism, shocking:
“The IG’s office reviewed the paperwork for studies tied to the 118 marketing applications approved by FDA in FY ‘07. They found that 42% of approved applications were missing financial information, and only 1% of investigators disclosed financial ties (!!!). What’s more, the FDA can’t know whether all clinical investigators have submitted financial disclosure statements, because the agency never gets a complete list of all clinical investigators (!!!).” Emphasis and !!! added.
There’s more, but that’s enough to raise a really important issue about healthcare delivery.
I think one central question for the e-patient movement in 2009 will be: What is the nature of “reliable information”? We were raised to trust medical journals and the randomized clinical trials that feed them. If that process is unreliable, no wonder many patients (including me) have found that the best information came from the patient community.
N.B.: It ain’t just patients who may be getting misled by this apparently misguided trust. What about doctors who were raised to trust those same sources?