The federal government has permanently halted two unusual studies that allowed San Diego-area paramedics to give trauma patients an experimental treatment without their permission or knowledge.
Officials recently announced that both studies are finished for good because early results didn’t show any benefit in patients who received intravenous drips of super-charged saline solutions instead of the usual salt water.
Such “no-consent” studies are controversial because they allow medical experimentation without permission, a once-common practice that is now considered unethical and a violation of human rights. Some researchers say exceptions should be made for emergency medicine research.
I wrote about these studies last fall after the federal government temporarily suspended them. At the time, officials expected they’d start up again in the county, which was one of several communities in the U.S. and Canada to take part.
One study was designed to reveal how best to treat patients with blood loss as they’re transported to the hospital after a traumatic injury. Patients were to receive either the usual treatment — an ordinary intravenous saline solution — or one of two types of super-charged saline solution that doctors hoped would reduce the side effects of injury.
As of last August, 103 local patients took part in the study. The federal government temporarily suspended the study at that time, and then announced in March that the research would cease permanently because the alternative treatments showed no benefit.
For the same reason, the government announced on May 12 that it had permanently cancelled a study of the use of alternative intravenous solutions in traumatic brain-injury patients. That study was also temporarily halted last year after 89 local patients had taken part.
Doctors, researchers and some ethicists support exceptions to “no-consent” rules in the world of emergency medicine because it’s impossible to get permission for treatment from patients who are often unconscious and dying.
But the practice is controversial and created a national stir when hospitals — including two in San Diego — gave fake blood products to emergency patients instead of the real thing from 2004-2006.