- http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/27/doctors-piece-together-rare-cases-fungal-meningitis-uncover-outbreak/55SIHvy58Pf8lCB0yFvpHJ/story.html?camp=aw&rico=1&zph=9avc
- http://www.bostonglobe.com/metro/2012/12/09/little-scrutiny-drug-compounder-expanded/smg30vIQyW7qbIgROxYpaK/story.html?camp=aw&rico=1&zph=9avc
- http://www.bostonglobe.com/lifestyle/health-wellness/2012/12/21/tainted-steroids-cause-spine-infections-addition-meningitis-all-patients-face-grueling-recovery/Wk6B2zgzyn8X7lM1PwBzhI/story.html?camp=a
Provide names of other journalists involved.
Carolyn Y. Johnson, Liz Kowalcyzk, Todd Wallack, Patricia Wen & Kay Lazar
List date(s) this work was published or aired.
10/28/12, 12/9/12 & 12/21/12
Provide a brief synopsis of the story or stories, including any significant findings.
At first there were four deaths and more than 25 people in five states infected with fungal meningitis, a disease so rare most doctors never see it. Investigators had linked the illnesses to a compounding pharmacy in suburban Boston, which made the injectable steroid given to all the patients. As the number of deaths and cases and states rapidly mounted, The Boston Globe deployed a team of reporters to not just report the news but to explain what had gone so terribly wrong. The story was unfolding fast, it was competitive, and it was complicated, involving medicine, a heretofore obscure corner of the pharmaceutical industry, and a complex patchwork of state and federal regulations. Explanatory journalism is most difficult under such circumstances, when there’s little time to think and analyze, but that’s when it’s most necessary. Even as we unearthed new information, we made what could have been a dense subject thoroughly absorbing, writing in a narrative style worthy of a detective novel. Reporters dissected documents and tracked down victims and salespeople, customers and competitors of New England Compounding Center to answer the many questions raised by the outbreak:
* Compounding pharmacies are typically small local retail stores that custom-make drugs, so how did New England Compounding grow into a national company that could endanger so many lives? Our reporting showed that the company cornered the lucrative pain market by promoting itself at medical conferences and faxing fliers to doctors. It sold drugs in bulk and without requiring individual prescriptions, a violation of Massachusetts regulations.
* Why didn’t regulators intervene? A decade ago, several patients had fallen ill with meningitis-like symptoms after injections with the company’s steroids. The Food and Drug Administration was so worried it convened a meeting with the Massachusetts pharmacy board. But the FDA decided it didn’t have legal authority to step in, and the pharmacy board dropped proposed sanctions when the company objected — even after one patient died.
* How did investigators crack the case? Around the country, people were showing up with unusual life-threatening symptoms, and doctors were confused and alarmed — one compared it to the early days of AIDS. Finally, a Tennessee doctor noticed her patient had received a pain injection and called public health officials, who learned other patients got similar shots.
* What’s in store for patients sickened by the contaminated steroids? They face an uncertain future. Treatments for fungal meningitis are arduous and not always effective, and many have suffered painful complications requiring hospitalization and even surgery.
In other stories not included in this entry (because we’re limited to three), we also illuminated a cozy relationship between the pharmacy board and New England Compounding: an executive of a sister company was the board’s president, and co-owner Barry Cadden served on a board task force. And we revealed that New England Compounding sent customers a “report card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
We submitted dozens of FOIA requests, some of which are still outstanding, for: FDA inspection records and correspondence related to New England Compounding and its related companies; Mass. and other states’ pharmacy boards’ inspection and licensing records of the pharmacy; DEA inspection records of the pharmacy. We also examined the Massachusetts Secretary of State’s online corporation records database to determine the interlocking ownership and management of New England Compounding and sister companies and local property records; an FDA database of inspection reports and notices of violations issued to companies nationwide, including NECC and related companies; New England Compounding documents posted by the FDA and state of Massachusetts listing the pharmacy’s customers and the drugs they ordered; and the CDC website tracking fungal meningitis cases and deaths and other infections. We obtained FDA and Massachusetts Pharmacy Board documents that had been provided to congressional investigators, congressional staff reports, and transcripts of congressional testimony from hearings a decade ago. We also did a computer-assisted analysis of the National Association of Boards of Pharmacy’s national disciplinary actions database to assess the performance of the Massachusetts pharmacy board (for a story not included in this entry). Finally, we used Accurint and LinkedIn to find former employees of New England Compounding and its sister companies.
Explain types of human sources used.
We interviewed dozens and dozens of people, including state and federal government officials, former FDA officials and current and former members of the Massachusetts pharmacy board and congressional staffers; infectious disease specialists in academia and with the CDC and state health departments; former salespeople and other employees of New England Compounding Center and its related companies, as well as acquaintances of its owners; physicians and hospital executives who purchased products from the pharmacy; and owners of other compounding pharmacies and industry consultants.
Results:
There are ongoing federal and state public health investigations into the causes of the outbreak, and a federal criminal probe. Massachusetts Gov. Deval Patrick has proposed legislation to revamp the state pharmacy board based on recommendations of a special state task force, and Congress and the Massachusetts legislature also have held hearings. While our reporting may have helped to shape the direction of some of these investigations, we can’t claim credit for initiating them.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
We continue to aggressively report on followup angles. We have run one correction (on a story not included in this entry): A story about layoffs at Ameridose, a sister company to New England Compounding, misstated the amount of Ameridose’s $1 million weekly payroll because the words “a week” were accidentally dropped from the story.
Advice to other journalists planning a similar story or project.
Put as many reporters as possible on a big story like this so you can pursue the many breaking news angles while at the same time stepping back to write the deeper, explanatory and investigative pieces. Find industry sources, especially competitors, customers, and consultants, who can explain the workings of the industry to you if, like compounding, it’s an obscure area. And former employees and former government regulators are indispensable.