Clinical trials are the last, most expensive part of developing new drugs. More than anything else, one set of facts reveals the current status of drug trials. Earlier this month the British Medical Journal (BMJ) published a study showing that fewer than half the trials funded by the U.S. government's National Institutes of Health were published in a medical journal within 30 months after completion. Even four years after trials are finished, one-third of these publicly funded studies remain unpublished. But at least sixteen prior studies cited by this recent article showed between 25% and 50% of trials funded by pharma remained unpublished for several years after they were completed. In other words, whether funding comes from government or from pharma companies, the results of approximately half of all clinical trials are buried.
The authors of the BMJ article exercise some chest thumping about hidden results impeding the scientific dialogue and so forth, but the real implications are simpler and more frightening. Researchers and pharma companies both try to associate themselves with favorable drug studies, while medical journals are biased in favor of publishing positive results that attract readers, advertising and frequent citations. Yet regulatory agencies and physician groups rigorously review the published findings on drugs when considering whether to approve and use them.
For these reasons, the registration and adoption reviews of drugs are inherently flawed in favor of showing their efficacy and safety.
Because the same level of hidden results exists for studies sponsored by the government and pharma, the matter is not simply a phenomenon of corporate greed. No doubt that plays a part, but factors such as job promotion at the universities, bureaucratic prestige and old-boy favoritism are also due a share of the blame.
The problem involves a larger medical-industrial-government complex that favors pushing new drugs onto the market for its own interests. Much as President Eisenhower's military-industrial complex justifies the perpetual development of new weapons systems by claiming national security, the medical-industrial-government complex shoves new drugs down the public's throats by using biased data and claims of improved health.
The situation was summed up by a sign at Occupy Wall Street that stated, "The system is not broken, it's fixed." When the fix is in, medicine cabinets start to resemble black boxes.
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