University of Colorado fails to act
Many of you are aware of, and participated in, our efforts to bring the behavior of the researcher who made outlandish, unsubstantiated comments in Newsweek regarding the connection between a rise in youth suicides and the drop in prescriptions for SSRIs. Because his study in NO way supported his over-the-top assertions, we filed a formal complaint with the University of Colorado. We just heard back from the University of Colorado Committee on Research Ethics (CRE), specifically, John E. Repine, M.D. who informed us that the CRE did not find sufficient evidence to warrant an inquiry. I invite you to judge for yourself. Here is our complaint:
I am filing this complaint in behalf of a group of scholars at the Institute for the Study of Therapeutic Change in response to Dr. Valuck's comments in the July 16 Newsweek article “Trouble in a Black Box.” Here are excerpts from that article and his comments:
"According to a new study in The Journal of American Psychiatry, the number of SSRI prescriptions for pediatric depression (ages 5 to 18) tumbled more than 50 percent between 2003 and 2005. In a troubling parallel development, the number of teen suicides jumped a record 18 percent between 2003 and 2004, the most recent year for which data exist. Are the two trends connected? Many experts say yes…
'You may induce two suicides by treatment, but by stopping treatment you're going to lose dozens to hundreds of kids. You're losing more than you're saving. That's the calculus,' says Dr. Robert Valuck, of the University of Colorado Heath Sciences Center, coauthor of the new paper.’"
The problem is that an examination of the study revealed that the "parallel" development was not parallel at all. An inspection of Figure 3 in the study clearly shows that the precipitous drop in prescriptions occurred AFTER the increase in suicides. Lifting the black box warning could put many children at risk. It is an egregious ethical violation for a researcher to respond to the findings as a "parallel development" while understanding full well that the precipitous drop in his study occurred after the increase in suicides. In addition, examination of the suicide data from the CDC reveals that the "jump" in suicides from 2003 to 2004 was in fact a return to normal levels after an unexplained temporary decline for the years 2002 and 2003. Again, this shows no relationship to prescribing patterns whatsoever reported in his study referenced in the Newsweek article.
While sloppy journalism and lack of fact checking is expected from the media, the bold and even outrageous comments that Dr. Valuck made went well beyond just an unfortunate misrepresentation of the data. His comments bordered on hysteria and fear mongering, far removed from an objective interpretation of the facts and offered a conclusion from the data that he must have known, as a study co-author, to be false. This is a serious ethical violation because it created unjustified fear and could potentially influence the repeal of a warning label implemented, after extensive scientific debate, to protect children. This was neither balanced nor ethical science especially as it involves a life-and-death issue impacting our nation’s youth. A New York Times article has since appeared raising this issue and questioning the conclusions of "experts" like Dr. Valuck.
Researchers, especially those funded by corporate interests have to be held accountable.
Thank you for your consideration.
If you disagree with the University of Colorado’s decision that there was not sufficient evidence to warrant an inquiry, please contact John E. Repine, M.D. at john.repine@uchsc.edu
FYI: The National Center For Health Statistics (a branch of the CDC) released preliminary death data for 2005. The suicide rate dropped from 10.9 per 100,000 in 2004 to 10.6 per 100,000 in 2005, a decrease of about 3 percent. 2005 was the first full year of the black box warning of possible suicides and suicidal ideation. The new data won't be broken out by age groups, genders and race until next summer, so for now it isn't possible to say how the 2004 and 2005 suicide data compared. But it appears to be a fly in the ointment to the increase in suicides caused by the Black Box Warning argument.
And finally, even if the two events (rise in suicide and decrease in SSRI prescriptions) did occur (but they didn’t), one should be cautious before reading much into a correlation, especially at such a large population level. Many other factors are involved. Following their logic, it could be argued that the dramatic increase in antipsychotic prescriptions to youth is causative to increased suicides.
Barry
I am filing this complaint in behalf of a group of scholars at the Institute for the Study of Therapeutic Change in response to Dr. Valuck's comments in the July 16 Newsweek article “Trouble in a Black Box.” Here are excerpts from that article and his comments:
"According to a new study in The Journal of American Psychiatry, the number of SSRI prescriptions for pediatric depression (ages 5 to 18) tumbled more than 50 percent between 2003 and 2005. In a troubling parallel development, the number of teen suicides jumped a record 18 percent between 2003 and 2004, the most recent year for which data exist. Are the two trends connected? Many experts say yes…
'You may induce two suicides by treatment, but by stopping treatment you're going to lose dozens to hundreds of kids. You're losing more than you're saving. That's the calculus,' says Dr. Robert Valuck, of the University of Colorado Heath Sciences Center, coauthor of the new paper.’"
The problem is that an examination of the study revealed that the "parallel" development was not parallel at all. An inspection of Figure 3 in the study clearly shows that the precipitous drop in prescriptions occurred AFTER the increase in suicides. Lifting the black box warning could put many children at risk. It is an egregious ethical violation for a researcher to respond to the findings as a "parallel development" while understanding full well that the precipitous drop in his study occurred after the increase in suicides. In addition, examination of the suicide data from the CDC reveals that the "jump" in suicides from 2003 to 2004 was in fact a return to normal levels after an unexplained temporary decline for the years 2002 and 2003. Again, this shows no relationship to prescribing patterns whatsoever reported in his study referenced in the Newsweek article.
While sloppy journalism and lack of fact checking is expected from the media, the bold and even outrageous comments that Dr. Valuck made went well beyond just an unfortunate misrepresentation of the data. His comments bordered on hysteria and fear mongering, far removed from an objective interpretation of the facts and offered a conclusion from the data that he must have known, as a study co-author, to be false. This is a serious ethical violation because it created unjustified fear and could potentially influence the repeal of a warning label implemented, after extensive scientific debate, to protect children. This was neither balanced nor ethical science especially as it involves a life-and-death issue impacting our nation’s youth. A New York Times article has since appeared raising this issue and questioning the conclusions of "experts" like Dr. Valuck.
Researchers, especially those funded by corporate interests have to be held accountable.
Thank you for your consideration.
If you disagree with the University of Colorado’s decision that there was not sufficient evidence to warrant an inquiry, please contact John E. Repine, M.D. at john.repine@uchsc.edu
FYI: The National Center For Health Statistics (a branch of the CDC) released preliminary death data for 2005. The suicide rate dropped from 10.9 per 100,000 in 2004 to 10.6 per 100,000 in 2005, a decrease of about 3 percent. 2005 was the first full year of the black box warning of possible suicides and suicidal ideation. The new data won't be broken out by age groups, genders and race until next summer, so for now it isn't possible to say how the 2004 and 2005 suicide data compared. But it appears to be a fly in the ointment to the increase in suicides caused by the Black Box Warning argument.
And finally, even if the two events (rise in suicide and decrease in SSRI prescriptions) did occur (but they didn’t), one should be cautious before reading much into a correlation, especially at such a large population level. Many other factors are involved. Following their logic, it could be argued that the dramatic increase in antipsychotic prescriptions to youth is causative to increased suicides.
Barry
posted by Barry at
7:35 PM
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