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Entries in Steroids (2)

Thursday
Oct112012

Fungal Meningitis Prompts Fear Among Steroid-Injection Patients

Jared Wickerham/Getty Images(NEW YORK) -- Jim McGuire is unlikely to forget waiting in a hospital bed for the results of his spinal tap, as a doctor walked into the room across the hall and told a stranger he'd met earlier in the day that she had tested positive for fungal meningitis.  The friend he made as they'd waited all day in the hospital was admitted on the spot.

And McGuire was next in line.

"I saw the doctors go in, and I thought, 'They're talking to her for quite a while,'" he said.  "I knew when she got her results that I would be next. "

McGuire, 51, is from Tennessee, the state hit hardest by the recent fungal meningitis outbreak with 44 cases, including six deaths to date.  Up to 13,000 pain management patients nationwide may have been exposed to fungal meningitis if they received compounded steroid injections manufactured by New England Compounding Co. in Massachusetts.  It is not spread person-to-person.

McGuire received his first steroid injection for back pain on Aug. 28, and learned Monday that his injection was among the three tainted batches NECC distributed nationwide, ultimately sickening 137 people in all and killing 12 of them.  McGuire's doctor ordered him to go to the emergency room immediately.  It was 9:30 a.m.

"It was kind of a chaos in the emergency room," he said.  "The triage for this was incredible.  There were beds lined up in the hallway.  As soon as one spinal tap was over, they were pushing another one in."

He sat hours in the waiting room next to the elderly woman who would later test positive, anxiously wondering whether he had the deadly inflammatory infection that affects the spine and membrane surrounding the brain, ultimately causing permanent neurological damage and death if left untreated.

Early symptoms can take weeks to appear and include headache, dizziness and slurred speech, but McGuire didn't have those yet.  The only way to know for sure was a spinal tap, in which spinal fluid is extracted and tested.

When McGuire finally lay down on his stomach for the test, doctors swabbed his back, and gave him one needle to numb the area and another to extract three vials of fluid.  The pain wasn't "ungodly" but he felt it, he said, especially when the needle brushed a nerve and sent an electric feeling down his leg.

When the doctor finally walked across the hall from his friend's room to his, he told McGuire he was meningitis-free.  He could go home.  It was 5 p.m.

Other steroid injection patients were able to avoid the ER, but they panicked just the same, prompting many to call their physicians for peace of mind.

"There's no question that we're getting a lot of phone calls," said Dr. David Kloth, a pain management physician and board member of the American Society of Interventional Pain Physicians.

He said the Connecticut facility where he works has received hundreds of calls from concerned patients even though no meningitis cases have been reported in the state.  Only one facility in Connecticut received the tainted injections.

Copyright 2012 ABC News Radio

Wednesday
Oct102012

Meningitis Outbreak Toll Rises Amid New Questions on Oversight

Jared Wickerham/Getty Images(WASHINGTON) -- As the death toll climbs to 12 in the nationwide fungal meningitis outbreak, calls for FDA oversight of the contaminated drugs that caused the outbreak continue to stack up from congressmen, doctors and think tanks.

All 137 confirmed victims of this outbreak received spinal injections of a compounded steroid, methylprednisolone acetate, manufactured by New England Compounding Company in Framingham, Mass. The special pharmacy that compounded drugs has since shut down operations and recalled all products. An estimated 13,000 patients are at risk because they received the injections, according to the CDC.

[For a map of cases by state, click here.]

"What is particularly tragic for the families of those who have been sickened or killed by the tainted drugs is that this situation was completely avoidable," said Dr. Michael Carome, Deputy Director of Public Citizen's health research group. Public citizen is a 41-year-old non-profit think tank in Washington, D.C.

Unlike other forms of meningitis, the fungal type is not spread person to person. It does, however, affect the spine and membrane surrounding the brain. Early symptoms of fungal meningitis are mild and include headache, fever, dizziness, nausea and slurred speech, but the inflammatory disease can later cause permanent neurological damage and death. Patients are told symptoms can occur up to a month after their spinal injections.

Carome said the meningitis outbreak highlights an oversight "failure" by the Food and Drug Administration, which knew the once niche pharmacy that tailor-made mixed steroids for individual patients had become a bulk drug manufacturer when it started compounding drugs in large quantities. As a drug manufacturer, New England Compounding Company would have been held to safety, effectiveness and manufacturing standards, but Carome said these were not enforced, calling it a "double-standard."

The FDA responded to Carome's allegations by saying that it is working with Massachusetts to identify and recall harmful products because the states have primary jurisdiction over compounding pharmacies. However, the FDA did not answer whether it knew NECC was manufacturing drugs in bulk before the outbreak. It's investigation is ongoing.

"Traditional drug manufacturers must adhere to rigorous drug safety standards intended, for example, to prevent the contamination of their products," he said. "But so-called compounding pharmacies engaging in large-scale drug production do not."

Earlier this week, Rep. Edward Markey, D-Mass., wrote a letter to the Food and Drug Administration to ask how the drug contamination happened and followed up by introducing new oversight legislation on Wednesday.

"Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer," Markey said.

With compounded drugs under attack, hospitals are pulling compounded steroids, according to board members from the American Society of Interventional Pain Physicians.

"The vast majority of hospitals and facilities have done that for liability reasons," said Dr. David Kloth, an ASIPP board member and pain management physician.

Although Kloth does not use the NECC compounded steroid that was tainted, he said it's important to remember that this is an aberration.

"I don't think compounding should be condemned for this," Kloth said. "There have been compounding pharmacies that have produced millions and millions of doses of units to patients safely."

Carome called for an investigation into the fungal contamination and said FDA officials should be held accountable if investigators learn existing regulations were not enforced.

For a full list of clinics that received the recalled lots of spinal steroid injections, CLICK HERE.

Copyright 2012 ABC News Radio







ABC News Radio