Though government bureaucracies are often deserving punching bags for critics, there are some instances where merely shifting the blame for a particular problem doesn't absolve individual responsibility.
Such is the case with a study by the General Accounting Office, which shows that 51.5 percent of all drugs approved by the Food and Drug Administration from 1976 to 1985 have been found to cause "serious" adverse reactions in some patients taking the medication.While that initial summary is undoubtedly alarming, a closer look at the specifics of the report shows that:
- The GAO didn't keep track of the numbers of people with "serious" adverse reactions. In theory, that means that just one unpredicted outcome could land a drug - which has helped untold thousands of people - on the GAO's hit list.
- Investigators didn't attempt to determine whether the risks for reaction could have been discovered during preapproval testing by the FDA. Isn't publishing such inflammatory figures without determining whether the FDA even had the capability to predict such effects a little like convicting of murder a mother who inadvertantly runs over her child? Where's the evidence to show grave irresponsibility? There is none - the GAO simply failed to do its homework.
- The GAO said many of the reactions documented in the report were manifestations of less severe side effects known by the agency at the time it approved the drug. Because the FDA is required by law to list the known possible side effects of any drug it approves, physicians and patients are expected to take the responsibility of determining whether any of the drawbacks listed could aggravate symptoms already being experienced by the user.
For years, the public has been crying for expedited approval of new drugs - and with some success. The push to approve AZT early on for treatment of AIDS has helped - and prolonged life for - thousands who needed the medication before final testing was complete.
Now the study criticizes attempts to get the drugs to market quickly, saying that drugs with serious postapproval risks were often approved in a shorter time than drugs found to have no risks. Small wonder.
The fact is, if Americans want the miracles that new drugs can provide, they have to be willing to take the risks associated with using them before several years of study has been completed. If a more ominous warning label needs to be attached to such medications, so be it.