List date(s) this work was published or aired.
6/25/2011, 8/20/2011, 12/26/2011
Provide a brief synopsis of the story or stories, including any significant findings.
These articles are part of a collection of stories about the dangers of hydrocodone, the key ingredient in Vicodin and the nation’s second most-abused medicine. For years the problem of hydrocodone abuse was overshadowed by concern over oxycodone, its chemical cousin. Oxycodone came in stronger versions, like OxyContin, and so it grabbed most of the headlines. This series of articles was prompted by a violent pharmacy robbery on Long Island. The robber took thousands of pills containing hydrocodone. My first enterprise piece used data from a DEA database to show how pharmacy robberies rose 81 percent in four years. But this led me to other discoveries about hydrocodone that I fleshed out over the next several months. In one package of two articles, I revealed how the DEA and FDA have been dragging their feet for 12 years on a review over whether to close a regulatory loophole that has fed hydrocodone addiction. Another story revealed that four companies are quietly developing pure hydrocodone drugs.This story alarmed drug control experts nationwide and dominated headlines.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The June 25 story on pharmacy robberies relied on a database that the DEA maintains. I requested the data after the Long Island robbery. I used Microsoft Access and Excel to tease out trends from this information. For the Aug. 20 story about hydrocodone regulation: Both the FDA and DEA had previously rejected FOIA requests for information about their review, invoking a clause that protects documents that could have an “inhibitive effect” on policy. So I turned to other methods to learn what I could. A source who is a former top DEA official tipped me off about court cases mentioning the study. Those case files led me to the original rescheduling petition, the original petitioner — and the shocking revelation that this all began in 1999. Another source gave me a document showing how the DEA’s secret dossier regarding the hydrocodone review had grown over the years. Next I went through hundreds of pages of FDA regulatory filings on related drugs, looking for mentions of the secret study. I was able to piece together a rough history showing how the DEA and FDA have been playing hot-potato with hydrocodone since the late 1990s, repeatedly passing responsibility back and forth without making a decision. Meanwhile, hydrocodone addiction has exploded. AP also filed its own FOIA requests with both agencies, trying to get access to the FDA’s file on the review. The agencies have only given us a small number of documents. We continue to fight for the rest. The Dec. 26 article on pure hydrocodone products built upon the other two articles. I had spotted a brief in a trade publication about Zogenix developing an acetaminophen-free hydrocodone. Because of my earlier reporting I realized this could be big. I read through Zogenix’s SEC filings and listened to quarterly earnings calls until I understood what they were doing. Buried deep in a 10-Q was a gold nugget: a sentence mentioning competitors suspected to be under development. Suddenly I had a trend. Two of the other companies refused to talk about their pipeline of drugs, so I had to use other means to figure out what they were doing. I mainly used reports of clinical trials filed with the National Institutes of Health. I also searched a database of patent applications and FDA manufacturing permits. Then I called some of my addiction-treatment sources and showed them what I had. They were stunned.
Explain types of human sources used.
I talked to doctors, pharmaceutical experts, patients and drug addiction counselors. A former high-ranking DEA official also provided invaluable guidance on a background-only basis. In May, weeks before the Long Island robbery, I had also interviewed a pharmacist on Staten Island who had been robbed twice in the previous year. The man had refused to be quoted for fear of retaliation by drug dealers. But in the wake of the Long Island killings I called him back and persuaded him to go on the record.
Results:
These articles received huge play and have had a big impact on readers, lawmakers and advocacy groups. The June 25 story ran in newspapers from the Washington Post to the New Zealand Herald. Newspapers that printed the story included the Newark Star-Leger, the Tulsa World, and the Virginian-Pilot. At least 332 websites used the story. Some TV stations used our numbers in localized versions of the story. The Aug. 20 on hydrocodone regulation was likewise a hit, running in hundreds of media. It prompted a bill in the New York state legislature, and the American Society of Addiction Medicine sent a formal request to the FDA to reschedule hydrocodone. New York Sen. Kristen Gillibrand sent a letter to the FDA and DEA demanding action. But the Dec. 26 story on pure hydrocodone was the real blockbuster. It ran on the front pages of at least 46 newspapers, including the Tennessean, the News and Observer, the Oregonian, the Charlotte Observer, Las Vegas Review-Journal, the Dayton Daily News and others. It appeared on more than 470 websites. One of the sources I talked to was contacted by radio stations from Florida, Texas, Oregon, New Jersey and California. ABC News did this matcher and TV stations nationwide did their own matchers, including WKYT, WPSD, WSAZ, and CarolinaLive. Time’s website ran an op-ed on this “super-duper hydrocodone.” The story generated editorials in areas with abuse problems, including: The Des Moines Register Lebanon (Pa.) Daily News Floyd County (Ky.) Times New York Sen. Charles Schumer sent a letter to the FDA warning it against approving any pure hydrocodone products.
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.
There was one correction on the Aug. 25 story, and it is appended to the story here. It corrected that Schedule III prescriptions can be refilled five times instead of six. It also clarified that state regulations about the storage of drugs may sometimes be stricter than the federal rules. Neither issue affects the substance of the article.
Advice to other journalists planning a similar story or project.
Don’t be discouraged by the lack of transparency at the FDA and DEA. There may be other ways of getting information, such as combing through lawsuits, financial filings or patent applications.