Now, it appears we have another inconsistency - Phase IV trials completed before July 1, 2004 aren't posted. Why that date? That's when Lilly implemented its policy, which says the drugmaker "discloses publicly all medical research results that are significant to patients, health care providers or payers â€“ whether favorable or unfavorable to a Lilly product - in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products."
A Lilly spokesman writes us to say the drugmaker posts "all phase 1-3 core efficacy and safety registration trials of all Lilly products approved between July 1, 1994 and July 1, 2004. Compounds approved after July 1, 2004 will have all Phase 1-3 trials conducted in support of the initial indication posted when the compound is approved and commercially available anywhere in the world. Phase 2-4 trial results on marketed products are posted for trials completed on or after July 1, 2004." He adds that least one Phase IV trial is posted for each of the following drugs: Cymbalta, Evista, Forteo, Humalog, Humatrope, Prozac, Strattera, Symbyax, Xigrix, Yentreve and Zyprexa. But again, Phase IV trials finished before July 2004 won't show up.
Why should this matter? Well, Phase IV trials are conducted to look at side effects and safety; long-term risks and benefits, and how well the drug works when used in a real-world population beyond a clinical setting. In other words, new info and fresh insights can be learned. For reasons that aren't clear, Lilly has chosen to use a specific cut-off date and, as a result, patients, health care providers and payers are denied an opportunity to know as much as possible about its meds. One question that may be asked: what may be learned from those unposted trials?
We recognize that some will say we are parsing, and they would be correct to note that Lilly has been more aggressive than many of its rivals in developing an online registry and disclosure policy. And others could say it's possible to locate trial info elsewhere. But the point here is that Lilly's ceo, and Lilly's stated policy, both used the word 'all' to describe their efforts at transparency. To be selective, however, is to be less than transparent.