Long wait for answers in US tainted drug outbreak

October 13, 2012 by Mira Oberman

Thousands of Americans who may have been injected with a tainted steroid will have to wait weeks to see if they have been infected with meningitis as investigators seek answers to a widening outbreak.

That is because testing for the carries its own risks and only a small fraction of the nearly 14,000 people exposed have gotten sick, health officials said.

"It will take months for this whole story to be told," said John Dreyzehner, head of the department of health in Tennessee, the hardest-hit US state.

The number of cases nationwide has risen sharply since began contacting patients in 23 states to warn them of the danger, climbing from 64 on October 6 to 185 on Friday. The currently stands at 14, with six of the fatalities in Tennessee.

Patients have been cautioned to contact their doctors if they develop any of the flu-like symptoms of the slow-moving infection, which causes an of the protective membranes that cover the brain and .

A long has complicated efforts—one patient did not develop symptoms until 42 days after receiving a tainted injection.

"We're not testing people generally unless there's a reason to test them because the test itself is not entirely benign," Dreyzehner told reporters Friday.

"It's fairly routine—it's a —but it's more significant than a simple and it's not entirely without risk."

While the test can catch signs of infection by a quick analysis of the spinal fluid, it cannot rule out a dormant infection and patients could need to be retested, he added.

Quick detection is key to keeping the infection under control, but patients will require at least 10 days and possibly as much as four to six weeks of hospitalization to receive intravenous anti-fungal therapy.

The has led to calls for tighter regulation of the loosely controlled pharmaceutical compounding industry.

Critics said have found a way to sidestep costly and strict oversight by classifying themselves as pharmacies, which are given freer rein to mix drug compounds for patients.

A senior official with the Food and Drug Administration said Thursday it is "really unfortunate" that it has taken a crisis to highlight the long-standing regulatory gap and called for more authority to oversee the industry.

"The world has changed a lot since the days of mortar and pestle, and this is the time for pharmacists, for lawmakers, for regulators and for doctors to sit down to grapple with this new model of pharmacy compounding and come up with a regulatory scheme that appropriately controls the risk," said Deborah Autor, deputy commissioner for global regulatory operations and policy.

Investigators have not yet determined how the steroids—which are typically injected into the spine to treat back pain—were contaminated but said 50 vials have already been found to contain fungus.

The New England Compounding Pharmacy has voluntarily shut down operations and recalled all of its products after it was discovered that three lots amounting to some 17,000 doses were contaminated.

The sheer volume indicates that the firm had broken the rules, officials said.

"NECC, under Massachusetts board of pharmacy licensing regulations, was licensed to deliver compounded products in response to individual patient specific prescriptions," said Madeleine Biondolillo of the Massachusetts Department of Public Health.

"And it looks through the investigation as though they have violated that aspect of the state licensing regulation despite their assertion that they were operating under the regulations."

Several lawmakers have already vowed to introduce new legislation to tighten oversight and Senator Richard Blumenthal has called for a criminal investigation.

The company had been warned by the FDA in 2006 that its practices were violating the rules and has also been under investigation by state authorities, who have the primary regulatory responsibility for pharmacies.

Meanwhile, the first class action suit against the firm was filed Thursday on behalf of a Minnesota woman who injected with the drug and had to undergo testing after she developed a headache and nausea. The court filings did not indicate whether Barbe Puro was actually infected with .

Explore further: US tainted drug outbreak rises to 185 cases

Related Stories

US tainted drug outbreak rises to 185 cases

October 12, 2012
The number of people believed to have been sickened by a contaminated drug rose to 185 Friday, but US health officials said the death toll from the rare meningitis outbreak held steady at 14.

US warns meningitis cases could rise

October 12, 2012
US authorities have managed to contact most of the thousands of people exposed to the tainted drug blamed for a meningitis outbreak that has killed 14, but warned the number of infections could rise.

Tainted drug death toll rises to 14 in US

October 11, 2012
The death toll from a deadly meningitis outbreak in the United States blamed on a tainted drug rose to 14 Thursday as the number of cases jumped to 172 in 11 states, health officials said.

Official: pharmacy tied to meningitis outbreak may have broken state law

October 12, 2012
(HealthDay)—The company at the center of the ongoing meningitis outbreak appears to have violated Massachusetts law by producing and distributing large quantities of a contaminated steroid compound, a state health official ...

US clinics rush to warn of tainted steroid; 5 dead

October 5, 2012
(AP)—Health providers scrambled to notify patients in nearly two dozen U.S. states that the steroid injections they received for back pain may have been contaminated with a deadly fungal meningitis. Five people have died.

Calls for more US oversight after tainted drug outbreak

October 11, 2012
A deadly meningitis outbreak in the United States blamed on a tainted drug has triggered outrage and calls for tighter regulation of the loosely controlled pharmaceutical compounding industry.

Recommended for you

Scientists develop infection model for tickborne flaviviruses

August 22, 2017
National Institutes of Health (NIH) scientists have filled a research gap by developing a laboratory model to study ticks that transmit flaviviruses, such as Powassan virus. Powassan virus was implicated in the death of a ...

Zika virus stifles pregnant women's weakened immune system to harm baby, study finds

August 21, 2017
The Zika virus, linked to congenital birth defects and miscarriages, suppresses a pregnant woman's immune system, enabling the virus to spread and increasing the chances an unborn baby will be harmed, a Keck School of Medicine ...

Fatty liver can cause damage to other organs via crosstalk

August 21, 2017
Nonalcoholic fatty liver disease is increasingly common. Approximately every third adult in industrialized countries has a morbidly fatty liver. This not only increases the risk of chronic liver diseases such as liver cirrhosis ...

Novel approach to track HIV infection

August 18, 2017
Northwestern Medicine scientists have developed a novel method of tracking HIV infection, allowing the behavior of individual virions—infectious particles—to be connected to infectivity.

Faulty gene linked to obesity in adults

August 18, 2017
Groundbreaking new research linking obesity and metabolic dysfunction to a problem in the energy generators in cells has been published by researchers from the Harry Perkins Institute of Medical Research and The University ...

Two lung diseases killed 3.6 million in 2015: study

August 17, 2017
The two most common chronic lung diseases claimed 3.6 million lives worldwide in 2015, according to a tally published Thursday in The Lancet Respiratory Medicine.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.