Michael Jackson’s death, on June 25, of an apparent cardiac arrest possibly due to an infusion of propofol, has focused intense scrutiny on the misuse of the sedative. But some anesthesiologists say much of the attention is unfair and uninformed. Although abuse of propofol appears to be on the rise—including among anesthetists—the central issue in the Jackson case for many clinicians is less where propofol should be administered and for what indications than by whom.

“To say that it’s about the site of service is irresponsible and incorrect,” said Marc Koch, MD, chief executive officer of Somnia, Inc., an anesthesia services provider based in New Rochelle, N.Y. “It doesn’t have to do with the site of service, it doesn’t have to do with the drug. It has to do with the provider. I’ve given propofol to thousands and thousands of patients in office settings, and Somnia has overseen propofol [administration] for well over 1 million patients in offices.”

Dr. Koch said he feared that the portrayal of propofol—now at times called “milk of amnesia” on the nightly news—by the mainstream media has unnecessarily stoked fears among patients. “Certainly the number of questions [about the drug] has gone up,” he said.

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‘As Deadly as They Get’

Jackson’s personal doctor, Conrad Murray, MD, bills himself as a cardiologist but is not board certified in that specialty. The Drug Enforcement Administration (DEA) have searched Dr. Murray’s Houston and Las Vegas offices, as well as his Las Vegas home, in search of evidence in Jackson’s death. According to news reports, a law enforcement official told reporters that Dr. Murray gave the entertainer propofol by IV sometime after midnight on the day he died. The Associated Press reported that Dr. Murray had given Jackson propofol “several times” for insomnia and that the singer had a walk-in closet stocked with the drug and other sedatives.

Dr. Murray’s lawyer, Edward Chernoff, said his client “didn’t prescribe or administer anything that should have killed Michael Jackson.”

“Anesthesia drugs are about as deadly as they get. That’s why you need a medical specialist trained in anesthesiology to be in control,” said Eugene Viscusi, MD, director of acute pain management at Thomas Jefferson University, in Philadelphia. “We have made anesthesia so safe that people are beginning to forget the risk,”  he added. “In reality, these drugs don’t make you better. The best you can expect is to break even—be the same as you were before.”

Since the approval of Diprivan (AstraZeneca) in 1989, the FDA has received 440 reports of deaths related to propofol. Of those, 129 (nearly 30%) have occurred since 2006, according to the agency.

Propofol experts said anyone without training in the administration of general anesthesia takes a great risk by using the sedative. Indeed, the warning label for Diprivan  states that “for general anesthesia or monitored anesthesia care (MAC) sedation, Diprivan Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Patients should be continuously monitored, and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available.”

For patients in the intensive care unit, the label adds, the drug “should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.”

According to the Web site TMZ.com, police investigating Jackson’s death found neither an electrocardiograph nor a pulse oximeter in the pop star’s rented Beverly Hills mansion. The online news service cited unnamed “authorities” who said they believe Dr. Murray may have fallen asleep after starting the propofol drip and that he awakened to find Jackson dead. TMZ has reported that Los Angeles law enforcement officials are treating Jackson’s death as a homicide.

Drug enforcement officials said the DEA has been involved in a two-year inquiry into whether to make propofol a controlled substance. Most anesthesiologists find that prospect concerning. An online survey in July by Anesthesiology News found that nearly 62% of respondents—who included some certified registered nurse anesthetists (CRNAs)—believe propofol is not sufficiently addictive to warrant DEA scheduling. However, more than 82% said their hospital or clinic had already taken steps to restrict access to the sedative, such as keeping it in locked cabinets, requiring clinicians to log the drug in and out and other measures.


Tug-of-War
      
The product label for propofol has been the subject of an ongoing tug-of-war between anesthesiologists and CRNAs, on one side, who believe that they alone are qualified to administer the drug, and gastroenterologists on the other, who have called for fewer restrictions on its use. The FDA so far has refused to remove the warning.  

To Dr. Koch, Jackson’s death should settle the matter. “Anesthesiologists and CRNAs should be the persons administering the drug. Case closed. I don’t care whether it’s given in a house, an office or a surgicenter. That’s the issue here and that’s what I tell patients.”

But Douglas K. Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, and an outspoken advocate for the administration of propofol by gastroenterologists, said the Jackson case should not affect the debate.  

“I don’t see how that’s really relevant to the administration of propofol by nonanesthesiologists with monitoring in hospitals and ambulatory clinics,” Dr. Rex said. “The evidence with regards to the published literature indicates clearly that nonanesthesiologists can administer propofol safely for endoscopic procedures and emergency room procedures, and there’s even emerging literature on bronchoscopy. It’s not really open to interpretation.”

Dr. Rex also noted that having an anesthetist provide sedation can increase the cost of clinical services, such as endoscopy, for patients—sometimes substantially. The use of anesthetists to administer sedation for normal risk patients for endoscopy is not cost-effective medicine,” he said.   
            
For anesthesiologists, said Dr. Viscusi, the additional cost of having a sedation specialist on hand is a modest price to pay for the extra safety they provide in the event of a problem.

Spike in Concern

Some anesthesiologists said they have seen a surge in concern among patients about the safety of propofol. Clifford Gevirtz, MD, medical director for Somnia's pain service, said he has had “several patients become very alarmed when they were told that were going to get the same drug as Michael Jackson.  I use the moment as a teaching point: As anesthesiologists, we know how to administer the drug safely and that we will monitor the patient closely.  This has reassured the patients and we haven’t had anyone cancel a case—so far.”

Yet not everyone is so receptive to the message. Elizabeth Frost, MD, clinical professor of anesthesiology at Mount Sinai School of Medicine in New York City, said that one of her recent patients “demanded to know if I was going to give her the ‘M.J.’ drug and leave her to die. I told her that anesthesiologists were trained to use propofol safely and she would have no adverse consequences.”

Dr. Frost said that after "considerable reassurance, we went ahead with the procedure with no adverse effect. Many patients have asked if the propofol we are using is the same as the 'M.J. one,' and how it is possible that it is available for home use," she added. "I tell them that it is not."