Evidence-based - EBM and Ethics of Experimental or Risky Treatments

EBM and Ethics of Experimental or Risky Treatments

Insurance companies in the United States and public insurers in other countries usually wait for drug use approval based on evidence-based guidelines before funding a treatment. Where approval for a drug has been given, and subsequent evidence-based findings indicating that a drug may be less safe than originally anticipated, some insurers in the U.S. have reacted very cautiously and withdrawn funding. For example, an older generic statin drug had been shown to reduce mortality, but a newer and much more expensive statin drug was found to lower cholesterol more effectively. However, evidence came to light about safety concerns with the new drug which caused some insurers to stop funding it even though marketing approval was not withdrawn.

Some people are willing to take their chances to gamble their health on the success of new drugs or old drugs in new situations which may not yet have been fully tested in clinical trials. However insurance companies are reluctant to take on the job of funding such treatments, preferring instead to take the safer route of awaiting the results of clinical testing and leaving the funding of such trials to the manufacturer seeking a license.

Sometimes caution errs in the other direction. Kaiser Permanente did not change its methods of evaluating whether or not new therapies were too "experimental" to be covered until it was successfully sued twice: once for delaying in vitro fertilization treatments for two years after the courts determined that scientific evidence of efficacy and safety had reached the "reasonable" stage; and in another case where Kaiser refused to pay for liver transplantation in infants when it had already been shown to be effective in adults, on the basis that use in infants was still "experimental." Here again, the problem of induction plays a key role in arguments.