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Fungal meningitis caused 37 needless deaths

The widow of the first patient who died from fungal meningitis due to  contaminated steroid injections told a Washington hearing her nightmare will  never end, but many of the almost 600 sickened from the steroid say their  nightmare doesn't seem to end either.

 

Ngoc Le and Joyce Peterson work to understand the nature of the fungal infection and how best to stop them. (CDC/UPI)

The widow of the first patient who died from fungal meningitis due to  contaminated steroid injections told a Washington hearing her nightmare will  never end.

Eddie C. Lovelace was a circuit judge in Kentucky. His wife, Joyce, described  him as very healthy until he was in a traffic accident last March that damaged  his spine. The 78-year-old did physical therapy and everything else the doctors  ordered so he could return to the bench, she said.

On Sept.  11, he had numbness in his hand, a bad headache, he fell twice and when he  said his legs didn't work he went to the emergency room. Several days later he  died.

"We will be living this nightmare for ages to come," Joyce Lovelace told a public hearing of the House Energy and Commerce Committee in November. "It's something probably we will never really be able to get closure [on] because it was just such a useless thing that happened to my husband.

"I want them to know -- whoever is responsible -- their lack of attention to  their duties cost my husband his life, cost my family, cost them a loss that  we'll never recover from."

Tennessee was the first state to report a case of fungal meningitis -- a  non-contagious form of meningitis caused by a mold spores, while other kinds of  meningitis, which are contagious, are usually caused by bacteria or viruses.

A patient treated at the the St. Thomas Outpatient Neurosurgery Center in  Nashville developed an infection after receiving methylprednisolone acetate  steroid injections for back pain. The center had 2,000 vials from the suspect  lots of steroid.

After Nashville reported a high number of similar infections, the Tennessee  Department of Health identified a methylprednisolone acetate -- an epidural  steroid injection administered June 27 to Sept. 20 -- as a prime suspect in this  outbreak and alerted the Centers for Disease Control and Prevention. The CDC  coordinated a multistate investigation.

The CDC confirmed the fungus Exserohilum rostratum was detected in unopened  vials of the preservative-free steroid produced at the New England Compounding  Center. The NECC produced about 17,000 doses of the injectable steroid, which  was shipped to 23 states and an estimated 14,000 doses were used to treat back  and joint pain. By mid-December, the CDC reported nearly 600 sickened from the  steroid, 37 dead.

NECC voluntarily recalled three lots of the steroid Sept. 26, but on Oct. 6,  the recall was expanded to all products compounded at and distributed from the  Framingham, Mass., facility. The pharmacy voluntarily closed and surrendered its  pharmacy license.

The U.S. Food  and Drug Administration advised physicians to follow up with patients who  were administered NECC injectable products and told them to watch for symptoms  including headache, fever, nausea, dizziness/unsteadiness, worsening lower back  pain, weakness or numbness, slurred speech, sensitivity to light, difficulty  walking and stiff neck.

Most patients became ill within four weeks following the injection, but  health officials said infections, meningitis and stroke could wait 42 days to  manifest. They estimated the peak of the illnesses around Nov. 6, but spinal  infections and other complications -- paraspinal/spinal infections, or epidural  abscesses -- continue to arise.

In October, the FDA investigation found a quarter of the steroid vials in a  NECC bin contained greenish black foreign matter, and several clean rooms -  where sterile products are produced -- had either mold or bacterial  overgrowths.

The FDA conducted several inspections of NECC, each based on a separate set  of allegations in 2002 and 2003 and one warning letter in 2006. The  Massachusetts Board of Pharmacy -- responsible for regulating compounding  pharmacies -- has an even more extensive history with NECC.

The U.S. House of Representatives' Energy and Commerce Committee's  Subcommittee on Oversight and Investigations released a 25-page report on the  history of NECC's regulatory issues in advance of a public hearing Nov. 13-14.

In 2011, the Colorado State Board of Pharmacy determined NECC was  distributing unlicensed and unregistered drugs in the state and issued a  cease-and-desist order. In addition, on April 18, 2002, the Massachusetts board  received a letter from the Nevada Board of Pharmacy describing allegations of  NECC selling non-FDA-approved products to physicians in Nevada, the report said.

At the hearing, Rep. Diana  DeGette, D-Colo., said Colorado officials notified the Massachusetts Board  of Pharmacy and it did nothing.

FDA inspectors and officials were repeatedly informed of problems at NECC,  but the strongest action taken by the FDA was a warning letter sent to the  company in 2006, a letter that appeared to have very little effect, DeGette  said.

"The FDA tells us that they were hobbled by questions about whether they had  the legal authority to address the problems," DeGette said.

In an article published in the Nov. 22 issue of the New England Journal of  Medicine, Kevin Outterson of the Boston University School of Law wrote since  1938, the FDA has had clear authority to regulate drug manufacturing but  compounding fell into a gray area between state and federal oversight.

Traditional compounding pharmacies -- which make individual medications  ordered by a doctor -- are not registered with the FDA and related adverse  events need not be reported to the FDA.

For more than two decades, the FDA struggled to regulate industrial-scale  compounding. In 1992, it issued a Compliance Policy Guide, attempting to police  the line between traditional compounding and drug manufacturing. This guide  attracted enough criticism that Congress created a statute in 1997, amending the  Food, Drug and Cosmetics Act with a new section, 503A.

But two days before this law was to take effect, seven compounding pharmacies  sued. Section 503A(c) banned the advertising and promotion of compounded drugs.  The theory was since traditional compounding occurred in response to individual  prescriptions, advertising was unnecessary, the article said.

In 2002, in a 5-4 decision in Thompson vs. Western States Medical Center -  an early example of the use of free speech against public health regulation -  the Supreme Court ruled compounders have a constitutional right to advertise  their drugs, Outterson wrote.

Outterson noted, some observers chastised the FDA for not acting sooner  against NECC, but this critique ignored the complex regulatory history. Although  the agency could react once a problem was obvious, it was unclear how it should  proactively gather information before a crisis erupted.

Thousands of U.S. compounding pharmacies are not registered with the FDA or  subject to reporting rules for drug manufacturers, so the FDA could be blocked  for many months from visiting them. Without information about the actual  conditions in compounding pharmacies, regulators cannot address violations, the  article said.

"It's possible that if the Supreme Court hadn't struck down Section 503A, the  tragedy at NECC could have been averted. Several features of that law are  relevant," Outterson wrote.

As the year came to a close, there are some 50 federal lawsuits in nine  states filed against NECC, and more are being filed in state courts alleging  NECC negligently produced a defective and dangerous product. The civil lawsuits  seek millions to repay families for the death of spouses, physically painful  recoveries, lost wages and mental and emotional suffering.

John Day, a Nashville attorney who represents several fungal meningitis  patients, told KVUE-TV, Austin, Texas, the lawsuits might take years and the  chance of recovering damages from NECC was extremely low.

NECC laid off its workers and surrendered all pharmacy licenses, and it's  unclear whether it had adequate liability insurance, Day said.

"It's clear to me that at the end of the day, NECC is not going to have  sufficient assets to compensate any of these people, not even 1 percent," Day  told KVUE.

Many attorneys are seeking compensation from other parties including NECC  pharmacist and co-founder Barry Cadden; co-founder Greg Conigliaro; sister  company Ameridose and its related  Medical Sales Management; pharmaceutical  distributors, and perhaps even doctors, hospitals, pain clinics, those who  actually injected the drugs and people who bought the drugs.

Source: http://www.upi.com/Health_News/2012/12/26/The-Year-in-Review-2012-Fungal-meningitis-caused-37-needless-deaths/UPI-22961356510600/

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