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Cardiac patients unknowingly receive placebo

Some ambulance patients in Niagara Region were unknowing participants in an experiment in which they may have received a placebo instead of previously approved emergency heart medication.

The test has been conducted six times since February by Niagara EMS paramedics when the previously approved protocol called for the injection of Lidocaine to help establish a normal heart rhythm in cases of ventricular fibrillation and tachycardia.

Patients may have received either of two drugs or a placebo of salt water solution (saline) if normal heart rhythm had not been established after at least one electrical defibrillation shock.

ALPS — short for Amiodarone, Lidocaine, Placebo study — is intended to test a new formulation of amiodarone and to test whether the administration of either of the anti-arrhythmic drugs is better than no drug at all for certain forms of cardiac arrest.

Neither the patients nor the paramedics know which substance is being injected in what is known as a “double blind” experiment, and the patients are not informed nor asked to consent.

“No consent is required,” said Niagara EMS commander of quality assurance, Karen Lutz-Graul.

There are some exemptions in consent guidelines for medical and clinical research, said Lutz-Graul, and the study has undergone and passed ethics reviews by federal, provincial and municipal authorities.

She said a notice was published in newspapers to inform residents of Niagara about EMS participation in the clinical trial.

She referred questions about research ethics to a physician who is site supervisor for the study but was not available for comment by press time, nor was a spokesman for the Niagara Health System research ethics review board which is believed to be one of the authorities that approved participation in the study.

The study is endorsed by universities and hospitals in North America and other organizations including the Canadian Institutes of Health Research, Heart and Stroke Foundation and the Department of National Defence.

ALPS is the clinical trial that was referenced when Niagara EMS issued a public alert June 25 when one of the packages of medication for the trial was lost after paramedics responded to a call in Niagara Falls.

The study originates from a research project at the University of Washington and is being conducted in a numerous jurisdictions in Canada and the United States and is expected to take another couple of years to complete.

Meanwhile, the lost package of medication has not been located but does not affect Niagara EMS’s participation in the study, said Lutz-Graul.

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