Yesterday we commented on the New York Times neglecting to mention -- in a story about clinical trial transparency and Prozac (along with other drugs) that Eli Lilly & Co. posts its clinical trials on a public website.
Well, sins of omission are seldom fun.
Here's Lilly's response:
INDIANAPOLIS, Jan 18, 2008
"Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials.
The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac -- the NEJM article didn't identify a single Prozac study as unpublished -- but it also likely created a strong false impression with readers that Lilly suppresses data.
Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results -- whether favorable or unfavorable to a Lilly medicine -- in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products.
In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004.
In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice -- first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004.
The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data.
We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it -- more than once -- in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times ... if only they had called and asked."
Has the New York Times changed its motto from "All the news that's fit to print" to "Don't ask, don't tell?"
Well, sins of omission are seldom fun.
Here's Lilly's response:
INDIANAPOLIS, Jan 18, 2008
"Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials.
The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac -- the NEJM article didn't identify a single Prozac study as unpublished -- but it also likely created a strong false impression with readers that Lilly suppresses data.
Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results -- whether favorable or unfavorable to a Lilly medicine -- in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products.
In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004.
In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice -- first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004.
The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data.
We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it -- more than once -- in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times ... if only they had called and asked."
Has the New York Times changed its motto from "All the news that's fit to print" to "Don't ask, don't tell?"
