Comparative effectiveness research becomes battleground

If you think about it for a little while, you will realize that while it is superficially appealing, the comparative effectiveness research is a sham intended only to beat down the pricing on new therapeutics. To show that drug A is superior to drug B you have to compare the full range of doses of A, B, and C - low, medium, high - and show that A beats B across the dose range. Plus you want to show that A beats Placebo. That means a 7-armed trial and that A has to win on at least 4 direct comparisons. With a Bonferonni correction for multiple comparisons it has to win at p<0.0125 on each comparison to get a positive trial. The probability for a type two error is such that you are very likely to fail on at least one arm even if you are in reality superior. AND EVEN IF YOU RUN this multi-thousand person 7 armed trial, the Agency will turn around and say - Ah, But you have to have TWO positive trials. Given that costs per patient, procedures etc vary from indication to indication, the reality is that for most therapeutic areas for chronic diseases you are talking a cost of $30,000 per patient PLUS CRO, data and analytic costs. A comparative effective set of two trials is easily a $70-100M expenditure, taking years, with a low probability of meeting the standard even if your drug is actually superior by a clinically important margin. And given that approval typically comes at 13 years into a 20 year patent life and that such trials would take years more plus FDA advisory time, any advantage would come in the last few years of patent life before generics cannabalize the product. Hence the bottom line is that comparative effectiveness trials will have an exceptionally low probability of success even with a better drug, will cost a fortune and will produce their results at a time in the product lifecycle when the yield is minimal. Nobody in their right mind would do such a program. The REAL point of the comparative effectiveness trials stems from their very impossibility. They enable payers to try to dictate pricing. End of story.

The problem with following through with the modifications for quality healthcare is top down communication verses lateral and the continuous authorization of unneeded grapevine communications held in the healthcare arena.

For instance, grapevine utilization is activated way before,the changem to create improvements. The culture of the alcholics, sick, drug abusers, step forward and create fear in their peers.
We forget employees come with his or her baggage. Some employees are alcoholics, drug abusers, ill, and simply dimented.
Most times we forget this population, whom do not have the capacity to use the cognition,to direct change in his or her department. The employees with the language barriers, tend to follow the maladaptive behaviors, because he or she is accustomed to his or her behavior.
Behavioral rational enotional therapy is not only for the patients, most employees need these focus groups during his or her meetings during work. These groups may prevent domestic abuse, and other maladaptive behaviors in all households. The need to treat everyone with undivided attention seems to be an answer.
The new study "Careology" Barb Guster 2008