Tested on the young, used on the old

Ever notice that medical devices are tested on non-Medicare populations and then paid for mostly by Medicare? Dr. Rita F. Redberg did. See (Medicare coverage decisions often based on trials in irrelevant populations)

“I was appointed to the [Medicare Evidence Development and Coverage Advisory Committee] MedCAC in 2002, and my first meeting was called because Guidant had requested expansion of defibrillator coverage in the Medicare population,” co-author Dr. Rita F. Redberg told Reuters Health. “In reviewing the technology assessment, it was obvious that the data were based on a population that was different than the population we were being asked if defibrillators would provide benefit for.”

“It was difficult to make that extrapolation, ‘how would the Medicare population do based on a study in middle-aged healthy men?'” she added. “It made me think that this was not an isolated incident.”

Sure enough, when Redberg and co-author Sanket S. Shruva looked at assessment of cardiovascular technologies between 1998 and 2006 they found that the hunch was true and their study (Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions) was published in The Archives of Internal Medicine published  on January 28, 2008.

The clinical trial participants tended to be about 10 years younger (70.8 v. 60.1) and much more likely to be male (75% v. 44%) than the Medicare population.

My understanding is that the vast majority of these devices are used in the Medicare population, so this is a legitimate point. Still, it would be a shame if the impact of this report were to require companies to do more or larger clinical trials, since it would raise development costs and keep some products off the market.

I’m sure it’s not easy, but it would be great to find a reliable way to extrapolate from typical study participants to Medicare members –or real world users of devices overall. I know that this is already done to some extent through the use of patient registries and databases such as ADHERE.

January 31, 2008

2 thoughts on “Tested on the young, used on the old”

  1. There are difficulties performing clinical trials in the elderly population. This is most often due to multiple comorbid illnesses in the older patients. Trials are usually designed to exclude such subjects lest their other illnesses cloud the outcome of the study and cast into doubt the significance of the results. Performing clinical trials is challenging to begin with because we are constantly assessing a sample of the general population and then applying these results to the world-at-large. The same statistical flaws can therefore theoretically affect clinical trials as they can New Hampshire poll results.

    While we would love to study outcomes in a target population with every intervention, researchers hold sacred the validity of their results. Having results as iron-clad as possible, therefore, means that one must remove any confounding variables.

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