A neurosurgeon at an American university hospital has been accused of experimenting on 3 terminally ill brain cancer patients without university permission.
Although the average survival for such patients in Oregon and nationwide is only about 15 months from diagnosis, the doctor’s unauthorized treatment may have hastened the patients’ decline, resulting in wrongful deaths. The doctor may now be facing a potential medical malpractice suit.
The doctor’s procedure involved introducing bacteria into the open head wounds of the patients. The doctor hoped that postoperative infections might prolong the patients’ lives. Specifically, he theorized that infection might stimulate a patient’s immune system, which in turn would help in attacking the cancer. However, the university has confirmed that 2 of the patients developed sepsis and died.
Under federal regulations, any research involving human subjects must be reviewed and monitored by an institutional review board. A university found to be in violation of that safeguard might be denied federal research money from the National Institutes of Health. In addition, unauthorized use of experimental drugs or medical devises can trigger an audit by the U.S. Food and Drug Administration, which has the power to disqualify researchers from further clinical studies.
In this case, the university hospital had 3 such IRBs. However, the doctor states that he did not contact them because he regarded his medical procedure as experimental treatment, not research. Although each patient had consented to the experimental treatment, such consent does not relieve the doctor from seeking proper FDA approval.
Although there can be risks associated with almost any medical procedure, patients deserve to be fully informed about all treatment options available to them, including potential side effects. In the event a treatment is experimental, that must be disclosed. If you believe your injury or condition was worsened because your doctor failed to fully inform you about a medical procedure, an attorney can get you the answers you need.
Source: The Sacramento Bee, “2 UC Davis neurosurgeons accused of experimental surgery are banned from human research,” Marjie Lundstrom, July 22, 2012