By guest blogger Daniel Hoffman:
Last winter the federal government’s Center for Medicare and Medicaid Studies (CMS) eased funding for physicians to adopt electronic medical records (EMRs), even as the agency also announced reimbursement penalties for those who refuse to make the conversion by 2015. While that may appear as merely a pedestrian matter related to bookkeeping, the fact is EMRs will bring major changes to medical practice and every other aspect of the healthcare system.
For the pharmaceutical industry the fact that all US physicians will maintain digital patient records represents both an embarrassment and a challenge. For several generations the clinical trials designed and sponsored by pharma companies provided the principal basis on which physicians selected drug therapies. The advent of universal EMRs in this country will soon permit retrospective analysis of these electronic databases as an alternative foundation for selecting cost-effective therapies. One factor behind the adoption of this new standard is the increasing percentage of physicians that implicitly say they don’t trust pharma’s clinical data.
The rising tide of distrust does not necessarily result from the industry’s deliberate misdeeds such as bribing investigators, ghost-written studies, or hiding critical results, although such pervasive practices didn’t help. The problems are more basic and would likely arise even if drug development had been a model of scientific probity and ethical integrity.
Pharmaceutical companies prospectively design clinical trials to get their drugs approved and to enhance their utility in the eyes of physicians. For this reason the designs they use, the measures of success they select and the comparisons they make are all intended to reflect favorably on their products. The fact that sponsoring pharma companies pay the pipers (i.e., the “independent clinicians”) means they get to call the tunes.
A second reason for doubting trials is the fact that even if rigorously pure scientists designed, ran and assessed them, clinical studies are not the real world. Patients prescribed medications in the real world are not carefully selected or closely monitored. They often miss doses and do other things that either prevent them from obtaining desirable results or expose them to dangerous side effects. For this reason a growing number of physicians claim that a more persuasive source of evidence consists of outcomes among patients that used various therapies in ordinary settings outside of clinical trials.
Pharma spokespeople may scream like banshees about the disparagement of their trials and the growing use of retrospective databases, but this is just another change due to the prohibitive cost of drugs. In European countries such as Great Britain, the National Institute for Clinical Excellence uses this type of database analysis to advise the National Health Service on which drugs to cover. Pharma companies make handsome profits in Europe, although not unconscionable profits. Selecting drugs by analyzing patient databases is one means to produce a similar result here.
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