| . Today's Managing Health Care Costs Number is $80 billion |
The US government dodged an $80 billion dollar bullet by requiring extensive testing before approval of Solanezumab, a new Alzheimer's Disease medication, according to new research in the New England Journal of Medicine. Eli Lilly did two human studies that found the drug no better than placebo, but subgroup analysis suggested that it might be helpful in those with especially early disease. A trial to examine this, however, also showed no effect of the drug.
That's bad news for Eli Lilly's shareholders -but it's good news for patients who won't be given (1) false hope (2) inevitable side effects and complications and (3) giant bills. And it's especially good news for Medicare. The researchers estimate that the cost of this drug to Medicare alone, were it approved, would have likely been about $80 billion over a four year period. This good regulatory outcome was only possible because the FDA takes its job seriously and looks to approve only drugs with a credible chance of improving patient health.
The FDA mission would change, though, if it followed the recommendations of a group of scientists and advocates writing for US Against Alzheimers. This organization (at least partially funded by the pharmaceutical industry) advocates that "the FDA should clarify for the field that a clinically meaningful benefit on a single primary endpoint of cognition or function is a sufficient basis for a New Drug Application filing." In other words, no need for new drugs to improve both cognition and function - improving one alone is enough. There is already substantial controversy about the current group of Alzheimers drugs approved under the current approach. These drugs consistently show modest improvement on psychometric testing which some critics feel is not clinically significant.
The current administration is clearly aiming to dramatically decrease regulation. But easing the rigor of drug approval, in a time when new drugs are always priced at very high prices, has the potential to dramatically increase the cost of health care. This is especially problematic in the US with direct to consumer advertising, where research shows that marketing
It's most important in the US that the FDA hold firm and not approve drugs that are of no marginal benefit, as once approved marketing (as opposed to research) can drive drugs to be blockbusters.
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