Schedule I Hearing Concludes; Judge’s Ruling Expected In December
udge Kimberly Mueller announced an end to five days of federal evidentiary hearings on the constitutionality of cannabis’ Schedule I status, requesting extensive briefings from the parties which realistically could delay her ruling by two months or more.
On October 30th, the final day of the often contentious review of complex scientific and policy evidence, former deputy drug czar Dr. Bertha Madras held her ground in insisting that cannabis lacks any accepted medical value, although NORML attorney Zenia Gilg managed to expose some of the researcher’s apparent biases. Following up on Dr. Madras’ stated opinion that too few clinical trials had been conducted with cannabis to satisfy FDA standards, Gilg presented the researcher with evidence that a majority of new drug applications approved by the FDA between 2005 and 2012 had included only one or two trials. After a couple of evasive answers, Madras finally admitted that “I never said there had to be more than one trial.”
Gilg, who had grown in equipoise through the course of the week and came out in top form on the hearing’s final day, scored again a few minutes later. Challenging her contention that there was no way to reliably reproduce the chemistry of a plant-based drug, Gilg forced Madras to admit that the federal government’s own cannabis farm, operated under the auspices of Dr. Mohamed ElSohly at the University of Mississippi, was able to control the chemical makeup of their produce and “manipulate it precisely for clinical trials.”
“So,” Gilg quickly followed up, “NIDA can reproduce this, but what’s happening in unregulated markets is not controlled?”
“Precisely,” answered Madras.
But by far the worst damage Gilg was able to inflict against the professor’s credibility came when she called her to answer for the very findings she cited in her declaration in favor of Schedule I status (thanks to John Balazs for posting these briefs). For example, Madras claimed that cannabis had a high potential for abuse in part because of the sheer prevalence of its abuse in absolute numbers, citing the annual NSDUH survey, which she declared one of the most authoritative data sets available to researchers studying US population trends. But when Gilg pointed out that the NSDUH survey actually showed that the number of diagnoses of cannabis use disorder remained flat from 2002 to 2012, Madras prevaricated, insisting that one had to also look at a separate study showing trends in adolescent use. But Gilg presented her with the very study she cited, and asked her to read the numbers showing that adolescent admissions for cannabis use disorder treatment had fallen over the same ten year period. Madras continued to demur, insisting she still needed to see “alternate numbers.”
Gilg lunged for the jugular. “So five minutes ago,” she demanded forcefully, “these were great data, but now they’re not good numbers?”
“I do not question the veracity of these numbers,” Madras finally admitted, calling them “solid surveys.”
Under Gilg’s interrogation, Madras also appeared to endorse a number of glaring double standards between what she called legitimate medicine and so-called “drugs of abuse,” which she defined as any agent which causes feelings of euphoria in the user. While testifying that she would be “comfortable” with a two-year period to test the long-term effects of a cannabinoid-based drug like Sativex, for example, she later testified that she would not be satisfied of the long-term effects of smoked cannabis without a study conducted over at least fifty years. She also drew sharp contrasts between the operation of endogenous cannabinoids like anandamide and exogenous cannabinoids like THC, labeling the former as “normal” and the latter as “abnormal” simply on the basis that cannabinoids like THC trigger feelings of euphoria in reward centers of the brain. She returned to the theme again when Gilg challenged her on the results of brain imaging scans which purported to show changes in brain structure in heavy cannabis users. “Perhaps,” she conjectured with a broad grin, “people who use marijuana simply begin with abnormal brains.”
Madras continued to insist on double standards when testifying about pre-clinical trials (such as experiments on rats) which she claimed showed evidence of cannabis’ long-term harm. Noting that Madras insisted that only randomized, double-blind, placebo-controlled trials conducted with human subjects according to the strictest possible methodological standards could prove that cannabis was a medicine, Gilg pointed out that the rat studies Madras used to make her case (which the professor called “not dismissible”) fell far short of such rigors.
“Why,” asked Gilg, “can we use them [animal studies] to show it’s bad, but randomized, controlled clinical trials are not good enough to show the medical benefits of cannabis?”
“Because,” answered Madras, “the participants of those [human] trials had smoked cannabis before the study.”
Dr. Madras confidently drew her conclusions from what she called a vast range of knowledge drawn from “reading the literature” on the effects of cannabis, but under Gilg’s questioning it soon became obvious that the professor had been somewhat selective with her readings. For example, despite the fact that Madras had earlier testified that she had tried to be “fair” in her presentation of the evidence, she admitted under oath that she was “aware” of a study which showed that teen cannabis use had gone down in Colorado after voters demanded legalization there, but that she hadn’t “excavated the data” on the report and thus could not comment on it. She weaved a similar dance on the risks of stoned driving, confidently citing studies which purported to show an increase of THC metabolites in drivers killed in roadway accidents; but when Gilg presented her with another study which appeared to present conflicting evidence, Madras testified that she did not “have time to excavate this manuscript, but I know it disagrees with other research I’ve seen.”
Responding to earlier testimony, in which Madras insisted that if Gilg “could find even one study which looked at the long-term health effects of marijuana, I’ll evaluate my position,” the NORML attorney presented the professor with the results of a study on the health effects of patients enrolled in the federal IND program for medical cannabis which showed no major health problems to result from daily cannabis use over multiple decades. Seeming to sag somewhat, Madras admitted that although she was “aware” of the IND program in question, she was “not familiar with the results” of the study shown, despite the fact that it met the criteria she had demanded.
When Gilg asked why Madras, a Harvard professor with access to a world-class medical research library, didn’t locate research which the NORML legal committee had found themselves, Madras admitted that “I was unable to find it. That was a failure on my part.”
“But,” Madras protested in her defense, “there are thousands of studies on marijuana. It’s very difficult to study all of them.”
reference source
http://theleafonline.com/c/politics/2014/10/s...-december/
udge Kimberly Mueller announced an end to five days of federal evidentiary hearings on the constitutionality of cannabis’ Schedule I status, requesting extensive briefings from the parties which realistically could delay her ruling by two months or more.
On October 30th, the final day of the often contentious review of complex scientific and policy evidence, former deputy drug czar Dr. Bertha Madras held her ground in insisting that cannabis lacks any accepted medical value, although NORML attorney Zenia Gilg managed to expose some of the researcher’s apparent biases. Following up on Dr. Madras’ stated opinion that too few clinical trials had been conducted with cannabis to satisfy FDA standards, Gilg presented the researcher with evidence that a majority of new drug applications approved by the FDA between 2005 and 2012 had included only one or two trials. After a couple of evasive answers, Madras finally admitted that “I never said there had to be more than one trial.”
Gilg, who had grown in equipoise through the course of the week and came out in top form on the hearing’s final day, scored again a few minutes later. Challenging her contention that there was no way to reliably reproduce the chemistry of a plant-based drug, Gilg forced Madras to admit that the federal government’s own cannabis farm, operated under the auspices of Dr. Mohamed ElSohly at the University of Mississippi, was able to control the chemical makeup of their produce and “manipulate it precisely for clinical trials.”
“So,” Gilg quickly followed up, “NIDA can reproduce this, but what’s happening in unregulated markets is not controlled?”
“Precisely,” answered Madras.
But by far the worst damage Gilg was able to inflict against the professor’s credibility came when she called her to answer for the very findings she cited in her declaration in favor of Schedule I status (thanks to John Balazs for posting these briefs). For example, Madras claimed that cannabis had a high potential for abuse in part because of the sheer prevalence of its abuse in absolute numbers, citing the annual NSDUH survey, which she declared one of the most authoritative data sets available to researchers studying US population trends. But when Gilg pointed out that the NSDUH survey actually showed that the number of diagnoses of cannabis use disorder remained flat from 2002 to 2012, Madras prevaricated, insisting that one had to also look at a separate study showing trends in adolescent use. But Gilg presented her with the very study she cited, and asked her to read the numbers showing that adolescent admissions for cannabis use disorder treatment had fallen over the same ten year period. Madras continued to demur, insisting she still needed to see “alternate numbers.”
Gilg lunged for the jugular. “So five minutes ago,” she demanded forcefully, “these were great data, but now they’re not good numbers?”
“I do not question the veracity of these numbers,” Madras finally admitted, calling them “solid surveys.”
Under Gilg’s interrogation, Madras also appeared to endorse a number of glaring double standards between what she called legitimate medicine and so-called “drugs of abuse,” which she defined as any agent which causes feelings of euphoria in the user. While testifying that she would be “comfortable” with a two-year period to test the long-term effects of a cannabinoid-based drug like Sativex, for example, she later testified that she would not be satisfied of the long-term effects of smoked cannabis without a study conducted over at least fifty years. She also drew sharp contrasts between the operation of endogenous cannabinoids like anandamide and exogenous cannabinoids like THC, labeling the former as “normal” and the latter as “abnormal” simply on the basis that cannabinoids like THC trigger feelings of euphoria in reward centers of the brain. She returned to the theme again when Gilg challenged her on the results of brain imaging scans which purported to show changes in brain structure in heavy cannabis users. “Perhaps,” she conjectured with a broad grin, “people who use marijuana simply begin with abnormal brains.”
Madras continued to insist on double standards when testifying about pre-clinical trials (such as experiments on rats) which she claimed showed evidence of cannabis’ long-term harm. Noting that Madras insisted that only randomized, double-blind, placebo-controlled trials conducted with human subjects according to the strictest possible methodological standards could prove that cannabis was a medicine, Gilg pointed out that the rat studies Madras used to make her case (which the professor called “not dismissible”) fell far short of such rigors.
“Why,” asked Gilg, “can we use them [animal studies] to show it’s bad, but randomized, controlled clinical trials are not good enough to show the medical benefits of cannabis?”
“Because,” answered Madras, “the participants of those [human] trials had smoked cannabis before the study.”
Dr. Madras confidently drew her conclusions from what she called a vast range of knowledge drawn from “reading the literature” on the effects of cannabis, but under Gilg’s questioning it soon became obvious that the professor had been somewhat selective with her readings. For example, despite the fact that Madras had earlier testified that she had tried to be “fair” in her presentation of the evidence, she admitted under oath that she was “aware” of a study which showed that teen cannabis use had gone down in Colorado after voters demanded legalization there, but that she hadn’t “excavated the data” on the report and thus could not comment on it. She weaved a similar dance on the risks of stoned driving, confidently citing studies which purported to show an increase of THC metabolites in drivers killed in roadway accidents; but when Gilg presented her with another study which appeared to present conflicting evidence, Madras testified that she did not “have time to excavate this manuscript, but I know it disagrees with other research I’ve seen.”
Responding to earlier testimony, in which Madras insisted that if Gilg “could find even one study which looked at the long-term health effects of marijuana, I’ll evaluate my position,” the NORML attorney presented the professor with the results of a study on the health effects of patients enrolled in the federal IND program for medical cannabis which showed no major health problems to result from daily cannabis use over multiple decades. Seeming to sag somewhat, Madras admitted that although she was “aware” of the IND program in question, she was “not familiar with the results” of the study shown, despite the fact that it met the criteria she had demanded.
When Gilg asked why Madras, a Harvard professor with access to a world-class medical research library, didn’t locate research which the NORML legal committee had found themselves, Madras admitted that “I was unable to find it. That was a failure on my part.”
“But,” Madras protested in her defense, “there are thousands of studies on marijuana. It’s very difficult to study all of them.”
reference source
http://theleafonline.com/c/politics/2014/10/s...-december/
