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Real life is not a clinical trial

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June 06, 2013

Author: Angela Herring



All clin­ical drugs are intended to go through lengthy and thor­ough trials before reaching a pharmacist’s shelves. These tests are designed in part to catch any adverse effects of the drug on the patients. But these clin­ical trials are extremely con­trolled and the test sub­jects are cherry picked from the patient pool, according to Nick O’Donnell, a recent grad­uate of Northeastern’s doctor of phar­macy pro­gram. The real world looks a lot dif­ferent than this, he said.

That’s why O’Donnell, in con­junc­tion with John Devlin, an asso­ciate pro­fessor of phar­macy prac­tice in the Bouvé Col­lege of Health Sci­ences, decided to delve a little deeper into one class of drugs: intra­venous seda­tives. Because of their sys­temic action, these drugs have the poten­tial to dis­rupt processes across the body.

Every time a patient expe­ri­ences an adverse effect of a drug—be it an increase in heart rate, the devel­op­ment of an infec­tion, a failure in the gas­troin­testinal track, or any­thing in between—the attending physi­cian has the option of reporting the event to a cen­tral data­base main­tained by the Fed­eral Drug Admin­is­tra­tion. Because the system is vol­un­tary, O’Donnell said, there are some serious reporter bias prob­lems built in. For instance, if a patient expe­ri­ences an adverse effect that doesn’t sur­prise the physi­cian, it’s less likely to be reported.

Still, the data­base rep­re­sents the most inclu­sive col­lec­tion of wisdom on drug side-​​effects post-​​marketing. O’Donnell used this infor­ma­tion to per­form the most com­pre­hen­sive exam­i­na­tion on the most often used IV seda­tives to date. He selected 2,500 anony­mous patients from the data­base, who col­lec­tively expe­ri­enced 6,000 adverse events over an eight-​​year period from 2004 to 2011.

He looked at the rel­a­tive inci­dence of events per organ system, including the neu­ro­log­ical, car­diac, res­pi­ra­tory, meta­bolic, and gas­troin­testinal sys­tems. He also looked at infec­tion rates.

“No one had looked at which seda­tives affect dif­ferent organ sys­tems the most,” O’Donnell said. Much of what they found was to be expected. But there were a few anom­alies that could never have been detected without this kind of search.

For instance, one of the seda­tives known to decrease blood pres­sure and heart rate was also asso­ci­ated with a large inci­dence of car­diac arrest, some­thing doc­tors would never have pre­vi­ously been con­cerned about with this par­tic­ular drug. Another drug com­monly known to affect the GI tract had sim­i­larly high rates of respiratory-​​related events.

O’Donnell pre­sented the work at the Research, Inno­va­tion, Schol­ar­ship, and Entre­pre­neur­ship expo, or RISE, ear­lier this year and earned an award in the Health Sci­ences cat­e­gory. “I enjoy this kind of work because I can turn the data I have into some­thing useful for the field,” he said.