Patients say their cases ignored in meningitis outbreak

• Health officials say no confirmed illnesses linked to other drugs from company
• Official count doesn't include those whose symptoms don't match profile of other victims
• Patient advocate believes illnesses going undetected

NASHVILLE -- After being treated with drugs from New England Compounding Center, 52-year-old Bret Moody was told he has fungal meningitis. He's infected with Aspergillus, the first contaminant found in a national outbreak of illness tied to tainted medication.

But when health officials count the nearly 500 people sickened by the moldy drugs, they don't include Moody and others like him who fail to match the profile of most victims.

Moody, who also has been diagnosed with leukemia, is one of many patients nationwide who question whether health officials are undercounting the victims of the crisis.

Some got the spinal steroid, methylprednisolone acetate, blamed for the meningitis outbreak that has killed at least 34 nationwide. Some, like Moody, got other drugs from the Massachusetts firm. But if their symptoms are not already linked to the outbreak, they say, medical professionals aren't taking their illnesses seriously.

Health officials say they are watching closely and haven't yet confirmed any illnesses related to other drugs from New England Compounding or its sister company, Ameridose, both of which recalled all products amid sterility concerns.

Developments last week, however, indicate that the scope of the outbreak could be wider than previously believed. The U.S. Food and Drug Administration reported finding a new batch of bacterial and fungal contaminants in drugs from New England Compounding. Meanwhile, the U.S. Centers for Disease Control and Prevention reported a surge in epidural abscesses and bone infections among patients treated with three suspect lots of methylprednisolone acetate. Previously, the dominant infection had been fungal meningitis.

Dr. Diana Zuckerman, president of the patient advocacy organization National Research Center for Women & Families, said she believes more illnesses caused by contaminated drugs may be under the radar.

"This is the tip of the iceberg," Zuckerman said.

Questions about infection

Molds such as Aspergillus are common in the environment and have been known to sicken patients with weakened immune systems in rare instances. But Moody and his wife, Joy, are convinced that his fungal infections were triggered by the drugs he was given through a port.

Like hundreds of others across the country, Bret Moody got a letter telling him that during a recent hospital stay, he was treated with drugs from New England Compounding.

The Oct. 29 letter from the Eliza Coffee Memorial Hospital in Florence, Ala., said three different drugs administered to him -- Toradol, Lasix and potassium chloride -- came from NECC during a 45-day stay ending July 26.

Although he did not get the spinal steroid directly implicated in the ongoing outbreak, Moody was subsequently diagnosed with pneumonia caused by Aspergillus. Later, Joy Moody said, he was told he had fungal meningitis.

After a second hospital stay in Alabama and treatment with antifungal medications, he was transferred to Saint Thomas Hospital in Nashville, she said.

When a spinal tap was performed in Nashville, "of course it came out negative, because he had been getting the antifungals," she said.

The Moodys say all they want right now are some answers, but so far they aren't getting them.

They say they have asked Coffee Memorial about how he became infected but have been rebuffed.

"They did get answers," said Coffee Memorial spokesman Tom Whetstone, adding that privacy rules barred him from discussing particulars of the case.

He said no drug used at the hospital has been implicated in any infections. Alabama Health Department officials said they have had no confirmed cases of patients infected from NECC drugs.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said that while the possibility of infections from NECC drugs other than methylprednisolone acetate was "a matter of substantial concern" initially, those concerns lessened as time passed and confirmed cases failed to appear.

Nonetheless, he said it was at least a possibility that a case like Moody's could stem from other drugs from the New England firm.

The CDC has received "numerous reports of events following use of other NECC products, said agency spokesman Curtis Allen, but so far has not confirmed infections linked to those drugs.

Confirmation "is complicated and involves gathering clinical and epidemiological evidence of an association," he said.

Jonathan Golubiewski of Bradford, N.H., who suffers from Lyme disease, has faced an experience similar to Moody's.

He said he was first told he had received injections from a tainted lot of methylprednisolone in his ankles and he couldn't have fungal meningitis, even though he had some of the symptoms.

Later, he said, he looked through his medical record and discovered that he had received potentially tainted steroid in a spinal injection as well.

One spinal tap showed a high white blood cell count, an indicator of infection, but a subsequent one showed it below the warning level, he said. An infectious disease doctor did yet another spinal tap and found it normal.

"I still have a constant annoying headache," Golubiewski said, and his back pain has become "more focal." He also has increased sensitivity to sounds.

"It's totally frustrating. No one is treating me," he said.

States without cases

Four of the 23 states that received potentially tainted methylprednisolone acetate have reported no illnesses. Three of them -- Connecticut, Nevada and West Virginia -- got the smallest amounts of the drug, 200 or fewer vials, in shipments to a single clinic.

California, however, was one of eight states to get more than 1,000 vials, a list posted by the FDA shows. The drugs were distributed among four facilities.

"We don't know the reason why we don't have any illnesses," said Ralph Montano, a spokesman for the California Department of Public Health. "Perhaps CDC may have a theory on that. We don't."

Some California patients have complained that their illnesses are not being counted. Montano said the state has reached out to all patients who may have been exposed.

"The counties that have each of those facilities in them ... worked with the facility on notifying every patient who received an injection at those facilities and checking with them for any illnesses," Montano said. "We found none. That's where we are."

Sherry Mindel, who received an injection with the recalled steroid medicine on Sept. 19, said California is missing cases because health officials have had inadequate follow-up.

"I think they have closed ranks among themselves," she said.

She said she received four phone calls within three hours on Oct. 5 from Universal Pain Management in Palmdale, Calif., but no one has checked on her since. Even when she began suffering uncontrollable shakes, her doctor did not report the problem as a possible complication from the tainted medicine, Mindel said.

Patient advocate Zuckerman said she believes many illnesses from contaminated drugs may be going undetected.

"We happened to find out about this because it is a very unusual type of meningitis," she said. "That's why it became obvious rather quickly, but it still took quite awhile.

"None of these compounded pharmacy drugs -- none of them -- are proven safe and effective in the usual way. There could be many, many more drugs out there"

Nefarious organism

Ken Pierce of Kuttawa, Ky., had his last epidural injection of methylprednisolone acetate at Saint Thomas Outpatient Neurosurgery Center in Nashville on Sept. 14. Seven weeks later, he began having headaches, stiff neck, pain and nausea.

Lumbar punctures showed a small elevation in his white blood cell count, but not enough to warrant treatment with antifungal medications, which can have serious side effects. An MRI showed a "small hot spot of inflammation" in the right rear of his brain.

Pierce, who is not counted among the sick, is scheduled for another MRI on Thursday. That test will determine whether his doctor prescribes an antifungal medication, he said.

Pierce wonders if he has contracted another type of infection from the medicine instead of meningitis or an epidural abscess.

"I truly believe you can have a fungal infection in your body somewhere else," he said. "I don't think the protocols call for enough or the correct testing to find that infection."

He said he feels unusually fatigued, which makes him wonder if his body is trying to fight off an infection.

"There's not a doubt in my mind that it's not in there somewhere," Pierce said. "It's a nefarious organism that can lie and wait for nobody knows how long."