A follow up to the noxious fearmongering and the failure of the media to look at the implications of Congressman Markey, Waxman and the esteemed expert in clinical trial design Charles Grassley to scuttle non-inferiority studies and demand randomized clinical trials to determine safety and effectiveness for all medicines: There is no other way to say it than to state that such an approach would harm the sickest and most vulnerable among us and cripple efforts to accelerate treatments for Alzheimer’s, cancer and AIDS. Perhaps that it why even the NIH regards this politically motivated and doctrinaire approach to be unethical
Consider the following study:
“Enrolling children with asthma in the placebo arm of a clinical trial is common, harmful and ethically unjustified argue researchers from the University of Chicago and the National Institutes of Health (NIH) in the January 2004 issue of Pediatrics. After a systematic review of all clinical asthma trials involving children in the United States published between 1998 and 2001, the researchers found that children with asthma were more than twice as likely to be harmed — defined as forced to withdraw from the trial due to asthma exacerbation — if they did not receive standard asthma therapy compared to children who received standard treatment.”
Or here’s another way to look at it. If, as Markey (who has also pushed for a federal G force standard for rollercoasters) had his way, Ketek would be taken off the market. t’s “lethal” says he. Try telling that to the hundreds of thousands of children who would have died from community acquired pneumonia without it.
To my mind, the real killer in all this is not Ketek, but the politically motivated decisions of pols like Markey who ignore science and mislead the media for their own self serving agenda.