Meningitis Sufferer Still Ailing, Pharmacy Policy Up in Air

Danny Lindenberg suffered for a month from the toxic effects of a drug meant to keep him alive, and aside from constant pain, all he said he remembers is chasing rabbits and squirrels through the hospital. The drug caused hallucinations, but those were the milder side effects. His wife, Carolyn, said she remembers watching Danny's eyes roll back into his head and holding his hands as he suffered his first seizure.Each of those initial 28 days was equally chaotic and agonizing, Carolyn said. Today Danny still suffers hallucinations, seizures and debilitating lethargy.Danny, an Evansville resident, was diagnosed with fungal meningitis in November 2012 after contaminated shots infected his spine with black mold.According to the Centers for Disease Control and Prevention, the contaminated shots were sold in 20 states. More than 700 people developed meningitis or other illnesses, and 61 died.Although the company responsible for the outbreak was shut down and the contaminated drugs were eliminated, similar facilities continue to endanger public health, according to a May 2013 report from a U.S. Senate health committee.Since last year's outbreak, at least 48 facilities have produced and sold unsafe drugs.State governments around the nation have increased scrutiny of the industrial-scale compounding pharmacies. These facilities—drug manufacturers in practice—lie outside the scope of stricter regulation because they're technically pharmacies.Now a bill is before the U.S. Senate that would empower the Food and Drug Administration (FDA) to regulate industrial-scale compounding pharmacies like the one that caused the outbreak.Danny and Carolyn said they don't know when his meningitis will subside and when the treatment will stop, but they do know they want the government to prevent these companies from causing another outbreak.Several states need to review their regulatory laws to prevent another outbreak, according to the Senate report.Black particles floated inside syringes at one facility in Florida, according to the report. Dosages in medicines produced by a Texas facility ranged from 62% of the declared amount up to 640%.Between 2001 and 2011, at least 25 deaths were tied to drugs produced and sold by companies like the one that caused last year's outbreak, according to the report. There were 13 deaths in 2011 alone.While dangerous facilities disseminated bad drugs, FDA regulators were halted.A 1997 law extending the FDA's regulation to industrial-scale compounding facilities was rendered unenforceable due to a clause concerning advertising.Although the FDA was defanged, the facilities weren't without regulation. States each have their own agency responsible for overseeing and regulating the facilities.In Indiana, the Board of Pharmacy can revoke pharmacists' licenses, shutting down facilities.The Indiana board is committed to protecting citizens, Director Greg Pachmayr said. Board investigators conduct unannounced inspections in compounding facilities.The pharmacy board is doing the best it can, pharmacy law expert and Purdue University professor G. Thomas Wilder said, but that might not be enough.Indiana's board has a handful of investigators, Wilder said. After last year's outbreak, other states' legislatures expanded their regulatory agencies' budgets and staffs.The Indiana General Assembly hasn't responded to last year's outbreak with similar legislation.Ninety-one people in Indiana developed illness or injury from the outbreak, and 11 died. FDA observers found unsafe conditions at an Indianapolis facility in April. Later that month, the facility recalled all its products, and no injuries or illnesses were reported.The Indiana Board of Pharmacy is probably under-budget and understaffed, State Rep. Steve Davisson, R-Salem, said. Davisson is Vice Chairman of the Indiana General Assembly's Public Health Committee.He said the Legislature will likely wait and see what happens to the bill in Congress. Voting on that bill isn't scheduled yet, so it's far from law.Opponents of expanding FDA regulation to industrial-scale compounding pharmacies say normal pharmacies, which compound every day for individual patients, will suffer greatly under stricter regulation.But the Senate bill is designed to balance regulation between state agencies and the FDA. Indiana's board would regulate small, normal pharmacies, for example, and the FDA would handle industrial-scale compounders.That's a valid fear, Wilder said, because compounding is very important to the healthcare industry.Compounding is the mixing of drug ingredients to the specifications of a physician's prescription. All pharmacists compound, but it becomes a problem when larger facilities employ it on a manufacturing scale.Overregulation of pharmacies conducting compounding can lead to higher costs for consumers. The vast majority of compounders are safe, Wilder said, but some industrial-scale compounders are unsafe.Indiana's board needs that help from the FDA regulating the facilities, Wilder said.While the legislative process grinds on, Carolyn and Danny are reminding others that victims of unsafe compounding need help, too."There are people out there suffering," Danny said. "They're losing their jobs, their houses and their lives."

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