EXCERPT: `Kill Shot' probes shadow industry, deadly disease

EDITOR’S NOTE – This is an exclusive excerpt adapted from ‘œKill Shot: The Untold Story of the Worst Contaminated Drug Crisis in U.S. History,’� by Associated Press investigative reporter Jason Dearen. The book chronicles the rare fungal meningitis outbreak in 2012 that killed more than 100 people, and infected some 750 others. When the first patients began dying, doctors were confused; none of the usual tests identified the cause. An epidemiological investigation would help expose a little-known part of the pharmaceutical industry: a compounding pharmacy where pharmacists mix customized drugs outside the purview of the Food and Drug Administration’s safety system. In 3 1/2 years of research and writing, Dearen drew on thousands of public documents, interviewed some 150 sources and reported from eight states and Washington, D.C. ‘œKill Shot’� is being published Tuesday by Avery Books, a Penguin Random House imprint. In this excerpt, Dr. Rachel Smith, a disease investigator with the Centers for Disease Control and Prevention in Atlanta, is looking into a mysterious cluster of deaths in Tennessee. Smith and her colleague, Dr. Benjamin Park, raced to discover if the problem was spreading, or confined just to Tennessee. They began by tracing the supply chain for every medical product used on the sick patients. ___ DAY 10: SEPT. 27, 2012: CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA Dr. Rachel Smith sat at her desk in a beige cubicle surrounded by a few dozen colleagues at the CDC. While the other scientists worked quietly, Smith had a telephone headset tangled in her hair and was dialing numbers as fast as she could. She had the unenviable but critical task of cold-calling 76 clinics and hospitals around the U.S. that had received thousands of vials of possibly contaminated steroids that had been injected into people’s spines. She started with those that had received the largest shipments. The previous evening, the CDC had sent out its first nationwide alert about the concerning meningitis-stroke cases over the Epidemic Information Exchange, or Epi-X: ‘œOn 9/18/2012, the Tennessee Department of Health was notified of a patient with culture-confirmed Aspergillus fumigatus meningitis following epidural steroid injection at a TN ambulatory surgical center. Patients have generally received antibacterial antibiotics without improvement. All patients received injections of preservative-free methylprednisolone, preservative-free normal saline, lidocaine, and skin prep with povidone-iodine. To understand the scope of this cluster and identify possible etiologies (sources), we are seeking information on patients with clinical meningitis or possible neurological infection following epidural injections since July 1.’� The decision to alert the nation had come 10 days after the first known case. Patient zero was a previously healthy man in his 50s who was close to death after a diagnosis of fungal meningitis and a devastating stroke. Two days before Smith’s flurry of calls, she and her boss, Dr. Benjamin Park, had spoken with a pharmacist named Barry Cadden. He was the owner of a compounding pharmacy located in suburban Boston called the New England Compounding Center, or NECC. His steroids were among a list of injectable drugs used on the ill patients, but he’d assured them that his drugs had been made under strict sterility standards. Park and Smith had to take his word for it; no one had inspected the pharmacy’s sterile ‘œclean rooms’� in years. They didn’t know NECC had signed fake prescriptions for patients named Donald Trump, Tom Brady and even Edgar Allan Poe. After the call with Cadden, NECC’s email appeared in Park’s inbox. Park double-clicked to open the attachment. He scrolled: some 17,675 vials from three different batches had been distributed to twenty-three different states.