Last week, we wrote about Lilly's approach to its policy concerning clinical trial disclosures. The impetus was
a recent speech by the drugmaker's ceo, Sid Taurel, who maintained that
all trial results are posted on a registry on the Lilly web site. And we pointed out an inconsistency regarding the Cialis erectile dysfunction med - Lilly boasts about results of 22 trials, but has so far posted just two and plans to, ultimately, post 15. And the others? Those won't be posted because the trials were conducted by ICOS, a company Lilly bought this year.
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 – 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.
3 Comments
Where are any trials of Zyprexa given to children? Nothing that I know of has been published even though they have been given off label for a long time. And now that it looks as if the FDA will cave and approve this most lethal atypical for adolescents, objective clinical trials become even more urgent.
Imagine if real trials had been made available back in 1996.
With regards to the Cialis issue, Lilly and ICOS have been 50/50 joint venture partners since 10/98 (Lilly ICOS LLC). The arrangement was to 'jointly develop and commercialize PDE5 inhibitors'. A global Phase III trial, started in 10/99, was presumably done under the 50/50 partnership. The product approval itself was addressed to Lilly ICOS LLC, at Lilly Corporate Center.
Lilly's excuse for not following their own disclosure policy, i.e. "since the compound was not a Lilly drug when it was approved, we have made the decision not to post the core safety and efficacy trial resultsâ€, rings hollow.
[...] but feels constrained. Here’s an example of trying but not quite getting there — Lilly’s clinical trial database is a half-measure, with too many exceptions and not enough [...]