Controversy
The thoroughness of carcinogenicity, teratogenicity, and toxicity testing in clinical trials has been questioned. In October 2002, India's Ministry of Health aborted the clinical trials due to reports of albumin in urine and scrotal swelling in Phase III trial participants. The Indian Council for Medical Research noted that dimethyl sulfoxide used as a solvent for the injection is known to cause kidney damage. Although the ICMR has reviewed and approved the toxicology data three times, WHO and Indian researchers say that the studies were not done according to recent international standards. Due to the lack of any evidence for adverse effects, trials were restarted in 2011.
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“And therefore, as when there is a controversy in an account, the parties must by their own accord, set up for right Reason, the Reason of some Arbitrator, or Judge, to whose sentence, they will both stand, or their controversy must either come to blows, or be undecided, for want of a right Reason constituted by Nature; so is it also in all debates of what kind soever.”
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