Drug Suspected in Michael Jackson Death Subject of Recall

By Sheri Fink, ProPublica

Results of Michael Jackson’s toxicology tests have not yet been released, but suspicions have centered on the powerful anesthetic and sedative drug propofol, also known by the brand name Diprivan. It was reportedly found in Jackson’s house, and a nurse who worked with him said he begged for propofol to help him sleep.

Now, some lots of propofol are being recalled for contamination.

Last night, the Centers for Disease Control and the Food and Drug Administration advised clinicians immediately to stop using propofol from two lots found to be tainted with elevated levels of endotoxin, a toxin made by bacteria. Regulators said Teva Pharmaceuticals, the manufacturer, had begun a voluntary recall of the lots.

Several drug companies are licensed to produce propofol in the U.S.

FDA spokesperson Karen Riley said the agency’s investigators were currently at the Irvine, Calif., plant where the tainted propofol was manufactured. She was unaware of the size of the lots. At least 39 patients had been affected in Florida, Arizona and Missouri since May, Riley said.

The CDC’s lead investigator on the case, Dr. Arjun Srinivasan, said clinicians across the country are being urged to check their inventories because the product was distributed nationally.
Srinivasan said the agency received an initial report about the drug from an outpatient surgery center on June 29. The Missouri center had 20 cases of patients who developed high fevers and muscle aches shortly after receiving the drug.

The CDC put out word to the FDA, state and local health agencies and providers. That quickly led to discovery of the tainted propofol and Monday’s warning, Srinivasan said.
All patients known to have been affected have recovered, he said. However, at high doses, endotoxins can cause a sequence of reactions, beginning with fever and progressing to shock and death.

There is no confirmation on whether Jackson received propofol before his death or whether, if so, the drugs reportedly found at his home came from one of the two tainted lots.
Teva Pharmaceuticals had no immediate details.

"Everybody seemed to find out about this before we did," a Teva customer service representative said today at noon. "We just found out about this an hour ago." She said company officials were meeting about the recall and would have a statement later today.

The drug is typically used to anesthetize patients for procedures such as colonoscopies. It can be dangerous if it is not administered carefully in a medical setting, and should not be used as a sleep aid.

Researcher Lisa Schwartz contributed research to this article.

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Consumer Demand Flavors Food Import Safety Issues

An ever-changing U.S. consumer who enjoys the convenience of ready-to-eat produce and seasonable fruits during the dead of winter has brought new challenges to food import safety, experts say.

With U.S. food imports set to top more than $2 trillion this year and expected to triple by 2015, a panel on food safety commissioned by President Bush met at Texas A&M University to discuss ways to strengthen the national and global import infrastructure.

Dr. Andrew von Eschenbach, Food and Drug Administration commissioner, says the nation’s consumer is one who “expects to eat strawberries in February.”

That has led to more change and complexity among how food is processed and delivered into the U.S. “This nation and the people we serve, and their health that’s so critically important, is threatened - not that we haven’t been doing a good job,” he says. “In fact, we’ve been doing an incredibly good job. But the world is rapidly changing around us. Although we have been the gold standard (in food safety), we must respond and be prepared for new challenges that are emerging from radical changes.”

Texas Agriculture Commissioner Todd Staples says “consumers’ tastes and preferences are changing. “They are demanding specialty products from around the world, seasonal products such as fruits and vegetables,” he says.

The working group, comprised of senior officials from 12 federal departments and agencies, is charged to report an action plan by mid-November. Additional information on the panel’s activities can be found at http://www.importsafety.gov.

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Blood Donations in U.S. Testing Positive for Chagas' Disease

In the 10 months since the U.S. Food and Drug Administration licensed the first blood-screening test for Chagas' disease, some 241 blood donations in the United States have tested positive, indicating donor exposure to the parasite known to cause this serious and potentially fatal parasitic infection, according to data released today at the annual meeting of American Association of Blood Banks (AABB). The test is manufactured by Ortho-Clinical Diagnostics, Inc.

Chagas'-positive donations have been reported in 34 states with the highest concentration in California, Florida and Texas, according to data compiled by the AABB.

Also called American trypanosomiasis, Chagas' disease is an infection caused by the blood-borne parasite Trypanosoma cruzi, or T.cruzi. The disease is endemic to most countries in Central and South America, as well as Mexico. Transmission occurs through insect bites, blood transfusions, organ transplants and via infected pregnant women to children in utero.

Early infection is usually mild and unrecognized, but persists lifelong and may lead to organ damage, particularly of the heart and esophagus, causing an estimated 50,000 deaths annually worldwide. Infection also can be severe in people whose immune systems are suppressed, such as organ transplant recipients.

During presentations at the conference today, blood safety experts also say they are investigating new cases of transmissions of Chagas' disease that may have occurred through blood transfusions and via insect bites from bugs known to carry the parasite. Such cases have been extremely rare, or have gone undocumented, in the United States. Dr. Susan Stramer, executive scientific officer for the America Red Cross, says blood safety experts are
investigating 20 cases of possible insect-to-human transmissions with strong evidence suggesting that nine cases may have occurred in the U.S. Also, the Red Cross is investigating four possible transmissions via blood transfusions. Details of these cases were not disclosed.

"While we have known that Chagas' disease was present in North America, the numbers of Chagas'-positive blood donations, as well as new reports of transmission of infection to persons from bugs, are surprising," says Dr. James Maguire, M.D., director, International Health Division, University of Maryland School of Medicine. Maguire is the former chief of the parasitic
diseases branch at the U.S. Centers for Disease Control and Prevention (CDC).

The American Red Cross was among the first blood collection agencies in the U.S. to begin testing donations for Chagas' in late January, following FDA approval of Ortho's blood-screening test in December 2006. Today, approximately 70 percent of all blood donations in the U.S. are now being screened for Chagas'.

In additional developments, public health authorities in the state of Arizona have made Chagas' a "reportable" disease. Three southern states are considering similar action. A reportable disease is one that must be reported to federal, state, or local health officials when diagnosed --
like active tuberculosis, hepatitis, gonorrhea and HIV, for example.

According to the CDC, as many as 8 to 11 million people in Mexico, Central America and South America have Chagas' disease. Most do not know they are infected. Chagas' disease can be treated successfully if detected soon after the infection occurs, but there is no cure once the
disease has entered the chronic stage.

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Vaccines Help Kick Drug Habits

A pair of new vaccines designed to combat cocaine and methamphetamine dependencies not only relieve addiction but also minimize withdrawal symptoms, according to study results presented by Baylor College of Medicine (BCM) researchers at the Annual Meeting of the College on Problems of Drug Dependence in Quebec City, Canada.

The vaccines stimulate the body to produce antibodies which then attack the drug while it is in the blood stream. This prevents the drug from reaching the brain and creating the reactions that contribute to dependency.

“These are therapeutic, not preventative, vaccines,” says lead investigator Thomas Kosten, Jay H. Waggoner Professor of Psychiatry & Behavioral Sciences at the Menninger Department of Psychiatry at BCM and research director of the Veteran Affairs national Substance Use Disorders Quality Enhancement Research Initiative. “They are meant for those who are already suffering from drug addiction.”

Kosten stresses that while the vaccines have been shown to help overcome drug addictions, they do not necessarily curb relapse.

“This is not a stand-alone treatment,” Kosten says. “There is a reason drugs were used in the first place, and that needs to be dealt with either through counseling or behavioral therapies.”
TA-CD, the cocaine vaccine, works through a series of injections over a three-month period. Study participants began to respond favorably to the vaccine after about a month. TA-CD has one more large scale human study scheduled before it is ready for the FDA approval process.

“The vaccine slowly decreases the amount of cocaine that reaches the brain,” Kosten says. “It’s a slow process, and patients do not go through any significant withdrawal symptoms.”

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Doctor Advises Caution Over Flu Drug

In this week’s BMJ, a senior doctor advises caution over the use of the antiviral drug oseltamivir (Tamiflu).

His concern follows advice by the Japanese authorities in March 2007 against prescribing oseltamivir to adolescents after the separate suicides of two 14 year olds who jumped to their deaths while taking the drug.

So far, oseltamivir has been thought to be well tolerated and safe, but the recent events in Japan have prompted a reappraisal, writes Simon Maxwell from the University of Edinburgh.

Before 2007, there had already been more than 100 reports of neuropsychiatric events (including delirium, convulsions, and encephalitis) with oseltamivir in children, almost entirely from Japan, which has the highest usage of oseltamivir worldwide. But a Food and Drug Administration (FDA) review concluded that these events were not clearly drug related.

Since last November, the FDA has required that doctors be warned that patients should be closely monitored for signs of abnormal behaviour throughout the treatment period and the European Medicine Evaluation Agency (EMEA) took similar steps in February.

In the UK, oseltamivir is a “black triangle” drug so it remains under more intensive surveillance and healthcare professionals are asked to report all minor as well as serious adverse events.
The controversy about oseltamivir is a further reminder that, although common adverse effects of a drug may emerge in prelicensing studies, the detection of rarer and potentially more serious events has to await exposure of large numbers of patients, he says.

In the light of these concerns, how should prescribers proceed?

There seems little doubt that oseltamivir reduces the number and seriousness of flu episodes when used as treatment and prophylaxis, he says. However, the impact of such events in otherwise healthy people is usually modest and of short duration, so they should be encouraged to use conservative strategies such as resting, increasing fluid intake, and taking simple analgesics.

In people at higher risk of serious complications the potential benefit of treatment seems greater, although convincing evidence about reductions in hospital admission or mortality is still awaited, he writes. In these groups, vaccination still offers a cost effective first line of defense.

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Suicide Attempts Decline After Depression Treatment

In a study of more than 100,000 patients treated for depression, suicide attempts declined during the first month of treatment—whether that treatment consisted of medication, psychotherapy, or both. The findings, published by Group Health researchers in the July American Journal of Psychiatry, show a similar pattern for populations of adolescents and young adults (up to age 24) as for older adults.

The study sheds new light on the “black box” advisory that the U.S. Food and Drug Administration (FDA) placed in 2004 and has revised since then, said Greg Simon, MD, MPH, the Group Health psychiatrist who led the study. The advisory—which has concerned many patients, families, and care providers—warns that suicidal behavior may emerge soon after people younger than 25 start treatment with newer antidepressant medications called selective serotonin reuptake inhibitors (SSRIs). It was spurred by randomized placebo-controlled trials showing that starting to take an SSRI can make thoughts of suicide more common among some teens and young adults.

Dr. Simon’s study is the first published research to compare the risk of suicide attempts before and after the start of treatment with not only antidepressants but also psychotherapy. It is based on computerized medical and pharmacy records for more than 109,000 patients who started treatment for depression at Group Health from 1996 to 2005.

In the study, suicide attempts were about twice as common among patients up to age 24 as among older adults. However, the time pattern was the same for both age groups, regardless of the type of treatment they received: Suicide attempts were most likely during the month before treatment started, falling by at least 50 percent in the month after treatment began, with steady declines thereafter.

At all time points—up to three months before and six months after starting treatment—patients who received their antidepressant prescription from a psychiatrist tended to be most likely to attempt suicide. Those who received it from their primary care doctor were least likely to attempt suicide, with levels in between for those who got individual psychotherapy from a therapist other than a psychiatrist. “That’s not because seeing a psychiatrist makes you want to kill yourself,” says Dr. Simon. Rather, he suggests, these results reflect the fact that people with severe depression, who tend to be more suicidal, are more likely to be referred to psychiatrists, while those with milder depression stick with their primary doctors.

“Our study indicates that there’s nothing specific to antidepressant medications that would either make large populations of people with depression start trying to kill themselves—or protect them from suicidal thoughts,” says Dr. Simon. “Instead, we think that, on average, starting any type of treatment—medication, psychotherapy, or both—helps most people of any age have fewer symptoms of depression, including thinking about suicide and attempting it.” That said, he likened population-based studies—both observational studies such as this one and randomized controlled trials of medications—to “circumstantial evidence” about what happens to individual patients.

Like other psychiatrists, Dr. Simon has seen a few depressed patients start having suicidal thoughts while taking antidepressant medication despite never having thought about suicide before then. He hypothesizes that subgroups of people may be vulnerable to becoming more agitated or suicidal after taking these drugs. “We hope to learn how to identify these people in advance,” he says.

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Researchers Find Deadly Prescription Drug Effects Six Years Before FDA

Northwestern University's Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADAR (Research on Adverse Drug Events and Reports) based out of Northwestern's Feinberg School of Medicine.

They swoop in to investigate early signs of trouble years before the Food and Drug Administration (FDA) takes notice.

A new study by Bennett, the A.C. Buehler professor in Economics and Aging at Northwestern's Feinberg School of Medicine, and a hematologist and oncologist at Northwestern Memorial Hospital, found RADAR identified serious drug reactions six years earlier than the FDA and drug companies.

RADAR's proactive safety efforts and reports also were much more comprehensive than those from the FDA or drug companies, according to the study. RADAR's reports provided doctors with important medical insights as well as guidance for prevention, diagnosis and treatment.
The study will be published in Archives of Internal Medicine.

Since Bennett launched RADAR in 1998, his research has resulted in black box warnings on billion dollar drugs like Plavix that may have saved thousands of lives. He has also provided guidance to help physicians more safely administer drugs. More than 100,000 people die each year from reactions to medications. The FDA is under attack for its passive and inefficient methods of learning about these problems.

Why is RADAR so nimble" Bennett's network includes hematologists and oncologists around the country and the world. His phone rings weekly with calls from concerned doctors alerting him to possible new trouble. After such a call, Bennett probes for clues that led to a life-threatening reaction to a drug. ‘What's the age and weight of the patient, x-rays, details of the physical exam and blood tests"' he'll ask. He'll canvas doctors to see if they've seen similar cases. If a vital piece of evidence is missing, Bennett even will track down a doctor at home on a Sunday and ask her to drive back to her office to check a chart. Then Bennett and his team fit all the puzzle pieces together to figure out what happened and how to prevent it in the future.

The new study also shows, however, that the FDA and drug companies were faster than RADAR to spread the word about serious adverse drug reactions. RADAR relies on publishing its studies in peer-reviewed medical journals, a process that takes longer than the FDA's warning letters to doctors and the drug companies' package inserts.

Thus, it's time for a formal collaboration between RADAR and the FDA to wed their strengths, said Bennett, who also is co-director for cancer control of the Robert H. Lurie Comprehensive Cancer Center.

"We need to work together as partners," Bennett says of the FDA. "Pharmaceutical side effects are one of the top five causes of death in this country. We want to move it out of the top five. This is the way to start that process and save thousands of lives."

Bennett envisions a formal partnership with the FDA in which he would share RADAR's investigations on safety issues, arrive at a joint insight on drug problems and have the FDA distribute the information to doctors.


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Bottled Water Industry Sees Growth in 2006

The International Bottled Water Association (IBWA), in conjunction with Beverage Marketing Corporation (BMC), today released bottled water statistics for the year 2006, compiled by BMC. These numbers show that U.S. bottled water sales and consumption continue to rise, with the latest upward trend reflected in 2006 when total bottled water volume exceeded 8.25 billion gallons, a 9.5 percent increase over 2005, and the 2006 bottled water per capita consumption level of 27.6 gallons increased by over two gallons, from 25.4 gallons per capita the previous year.

Additionally, the wholesale dollar sales for bottled water exceeded$10.8 billion in 2006, an 8.5 percent increase over the $10 billion in2005. These statistics demonstrate continued consumer demand and appreciation for the convenience and good taste of bottled water brands consumed on-the-go, during exercise, at restaurants or meetings, and at home or the office, according to the association. However, consumers should also know that bottled watersafety and quality result from multiple layers of regulation and standards at the federal, state and industry levels, the association says.

Bottled water is regulated by the U.S. Food and DrugAdministration (FDA) as a packaged food product, and has issued standards for safety, quality, production, labeling, and identity. Along with the FDA's Good Manufacturing Practices (GMPs), which are required of all foods, bottled water must comply with several other applicable regulations, including Standards of Identity, Standards of Quality and additional, specific bottled water GMPs. Being a packaged food product,bottled water is also bound by the Nutrition Labeling Education Act (NLEA) and the full range of FDA protective measures designed to enforce productsafety and protect consumers, the water association says. States also regulate bottled waterinspections, sampling, analyzing and approving bottled water sources, it adds.

"While all beverages have their role in a marketplace with an abundance of drink choices," says Stephen Kay, IBWA vice president of communications, "consumers are choosing bottled water as a refreshing, hydrating beverage and as an alternative to others that may contain calories, caffeine, sugar, artificial colors, alcohol or other ingredients,which they wish to moderate or avoid. For instance, during 2006, individual servings of bottled water in sizes of 1.5 liters and smaller accounted for 57.1% of the volume of bottled water sold, indicating that consumers are choosing bottled water in lieu of other bottled drinks."

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