Limited recall of drug central to Jackson probe
(Agencies)
2009-07-15 08:42
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LOS ANGELES – A maker of the potent anesthetic propofol found in Michael Jackson's home has been contacted by federal officials investigating the pop star's death and has recalled tens of thousands of vials of the drug after two tainted lots sickened dozens of patients.
There is no apparent connection between the bacterial contamination that prompted the recall and Jackson's death on June 25, Teva Pharmaceuticals spokeswoman Denise Bradley told The Associated Press on Tuesday. The tracking number on the tainted lots was different from the number on a vial that Drug Enforcement Administration investigators told the company was found at Jackson's home, she said.
Propofol usually is administered intravenously in hospitals to patients who need to be unconscious for surgery or other procedures. A central question in the Jackson investigation is who provided that drug and other prescription medications found at his rented Beverly Hills mansion. Investigators are talking to doctors who treated Jackson.
On Tuesday, Los Angeles assistant chief corner Ed Winter went to the offices of Dr. Arnold Klein, Jackson's dermatologist, seeking subpoenaed medical records. He did not get the documents but said Klein's office had promised to provide them.
Klein has said he sometimes sedated the pop star for medical procedures but never prescribed propofol.
Meanwhile, a nurse who provided nutritional therapy for Michael Jackson said Tuesday that she was interviewed by Los Angeles homicide detectives who told her needle marks were found on the pop singer the day he died. Cherilyn Lee said she told the detectives that she didn't see any so-called "track marks" on Jackson's arms when she visited his home to provide vitamins and other supplements earlier this year.
The detectives replied that "the day the paramedics came (to Jackson's house), he had a lot of track marks," Lee said.
Lee also was asked in the 20-minute interview at her office last Friday if she saw bruising on Jackson. Lee said she didn't but told police Jackson's veins were small, which made placing an IV needle difficult and could result in bruising.
Lee has said Jackson asked her for Diprivan, the brand-name version of propofol, to alleviate his insomnia. She said she refused to help him get access to the drug.
Lee, a registered nurse, said Jackson had complained of sleeplessness and told her he knew that Diprivan could provide immediate relief. She cautioned him the drug was to be administered in a hospital under careful supervision and had potentially dangerous side effects.
Jackson replied that he would be "fine as long as I'm monitored. ... He knew that somebody should monitor him with equipment," Lee said, which she took as an indication that he had used Diprivan before.
Lee was asked if there was an IV pole at Jackson's house, and told detectives that the only one she saw was the one she brought to administer a vitamin-mineral supplement, known as a "Myers' cocktail," through a needle placed in the back of Jackson's hand. While administering the vitamin IV on several occasions, Lee said, she needed to move Jackson's sleeves up his arms and saw no evidence of needle marks. She treated the singer from January to April.
Jackson investigators are seeking to trace how propofol ended up in his home. Teva can provide information on which distributor bought specific vials. From there, distributors typically sell directly to hospitals or doctors.
Bradley said she didn't know which distributor handled the drug found at Jackson's home. DEA spokesman Rusty Payne declined to comment.
Teva announced it was recalling two lots of propofol — 57,620 vials in all — after concluding bacterial contamination caused up to 40 patients in Florida, Arizona and Missouri to develop fevers and chills since May. Investigators believe vials were distributed nationally and are urging doctors not to use any propofol from the two lots.
Most of the affected patients were undergoing an endoscopy, an examination in which a tube-like instrument, usually with a camera attached, is passed into an area of the body such as the colon or esophagus. One patient was hospitalized and all recovered, said Dr. Arjun Srinivasan, lead investigator for the U.S. Centers for Disease Control and Prevention.
Karen Riley, spokeswoman for the Food and Drug Administration that oversees drug recalls, said the contamination was found in a single outpatient facility in each of the three states. She did not identify the sites.
FDA investigators arrived Monday at the Teva plant in Irvine, Calif., where the suspect lots were made and were looking for any irregularities in the manufacturing process, Riley said.
Investigators believe that bacteria in vials of the anesthetic released toxins into the drug which caused the fever, Srinivasan said.