By Scott Dance, The Baltimore Sun
7:05 PM EST, November 14, 2012
— Pikesville resident Gerald Cohen was an active 71-year-old retiree, filling his free time with gardening, volunteering and enjoying the company of his grandchildren despite persistent back pain — until he sought relief for it.
Treated with steroids in the past, he received spinal injections of the medication again in August and September at a Baltimore-area clinic. But this time, side effects came quickly and severely — nausea, neck stiffness, fever and eventually a stroke. Aside from the physical ailments, he grew irritable and started seeing a psychologist over nightly worries that he wouldn't wake up the next morning.
"I was overcome with fear," Cohen said, standing alongside his wife, Harriet, at a news conference U.S. Rep. Edward J. Markey held Wednesday. "I told her I thought I was dying."
Since learning that both of the steroid doses were among the tainted batches linked to a Massachusetts facility, Cohen has joined Markey in a campaign to prevent such an outbreak from occurring again. As Congress delved further into the crisis in a hearing Wednesday, some lawmakers and Food and Drug Administration officials launched an effort to close what they call regulatory loopholes that allowed the compromised steroids to go undetected.
An outbreak of 461 cases of fungal meningitis, causing 32 deaths across the country, is linked to more than 17,000 doses of the steroids distributed across 23 states from the New England Compounding Center in Framingham, Mass. Twenty-three meningitis cases and one death have been reported in Maryland, but there are also thousands across the state and country like Cohen who received the injections and are seeing their health deteriorate or fear it will worsen soon.
In an investigative hearing before a House subcommittee, members of Congress heard from those affected by the outbreak and agreed the crisis should not be repeated. But there was some debate over how the outbreak could have been prevented — and whether it would take legislation giving the FDA greater authority.
The problem, FDA Commissioner Margaret Hamburg told the panel, is that facilities like the Massachusetts compounding pharmacies are regulated by states but some are increasingly having a national reach. Traditionally, compounding pharmacies have been small facilities that fill specialized prescriptions, such as those that require smaller-than-normal doses or mixing of drugs that are no longer sold commercially.
But as hospitals have moved to increase outsourcing of pharmacy services, many compounding pharmacies have grown in scope to act effectively as drug manufacturers, Hamburg said. While the FDA's authority over manufacturers is clearly spelled out in law, Hamburg called its oversight of facilities classified as compounding pharmacies fragmented, limited and contested.
Markey's proposed legislation would preserve states' oversight of small compounding pharmacies but would increase scrutiny and transparency of larger facilities. The Verifying Authority and Legality in Drug Compounding Act would require compounded drugs to be labeled as such and large compounding pharmacies acting as drug manufacturers to be regulated as such.
"If we fail to act, this type of incident will happen again," Hamburg said. "It's a matter of when, not if."
Members of the panel spoke of a need for bipartisan cooperation.
"This tragedy demands action from this Congress," said Rep. Henry A. Waxman, D-Calif., who urged his colleagues to take up the issue by the end of 2012 and their lame-duck session.
But there were questions among Republican members about whether more regulation is needed to ensure tainted drugs don't fall through the cracks in the future. They cited a warning letter the FDA sent to the New England Compounding Center in 2006 threatening seizure of drugs or shutdown of the facility over an unrelated issue and asked why the same thing wasn't done before the contaminated steroids were distributed.
"We're not buying it," Rep. Tim Murphy, R-Pa., said of the FDA's assertions. "There is no ambiguity."
Regardless of the conflict, those affected by the outbreak urged action. Cohen spoke to reporters before the panel's hearing, while the wife of the first patient to die in the outbreak gave emotional testimony to the members of Congress.
Kentucky Circuit Court Judge Eddie Lovelace became ill Sept. 11 after receiving a tainted spinal injection, and his health quickly deteriorated until he died from what doctors said was a stroke six days later, said his wife, Joyce Lovelace. It wasn't until a newspaper reporter called her Oct. 5 asking her whether her husband was the 78-year-old Kentucky man authorities said had died of fungal meningitis that she began to piece things together.
"It was not an easy death that we witnessed," Joyce Lovelace testified. "Whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life."
For those who are still fearing the effects of the steroid, it is a trying wait. Cohen underwent a painful spinal tap to test for fungal meningitis, but the result was negative. He will have to wait at least 30 days before testing again, but in the meantime, his life has turned dramatically.
"He's not really himself," said Harriet Cohen. Once easygoing, he has become and he is constantly exhausted despite an end to his busy schedule. He can no longer drive himself and relies on his wife for help with everyday activities.
Pikesville law firm Janet, Jenner & Suggs LLC is representing Cohen and several other Marylanders who received the contaminated steroids or other medications compounded at the Massachusetts facility. The firm has not filed any lawsuits yet, attorney Justin Browne said, but the lawyers are working to gather information on each of the patients' cases.
In the meantime, Cohen said he hoped lessons could be learned from the outbreak.
"I hope this epidemic will lead to constructive change in the way compounding pharmacies are regulated," Cohen said. "After tragic events, everyone always says 'Never again.' But 'never again' never comes true if you don't do something different the next time."
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