IN THE NEWS
IRE and NICAR offer data, stories and tipsheets to help cover the latestOther resources for covering the news
Vioxx judgment
Aug. 19, 2005
Following the verdict in the first lawsuit against Merck about Vioxx,
IRE and NICAR have compiled data, related stories and tipsheets to help
journalists cover the case and its effect on similar cases.
| Data from the IRE and NICAR Database Library | Information from IRE publications |
| Stories available from the IRE Resource Center | Tipsheets available from the IRE Resource Center |
Databases
Adverse Event Reporting data
The U.S. Food and Drug Administration relies on the Adverse Event Reporting system to flag safety issues and identify pharmaceuticals or therapeutic biological products (such as blood products), for further epidemiological study. It may ultimately prompt regulatory responses such as drug labeling changes, letters to health care professionals, or market withdrawals. The agency requires product manufacturers and distributors to report adverse events regularly in accordance with 21 CFR 310.305 and 314.80. Mandatory reports for drugs in clinical trials and newly marketed drugs are submitted in various forms: 15-day alerts, quarterly or annual updates. The MedWatch program also collects voluntary reports from health care professionals and consumers. Adverse drug experiences include any serious and unexpected consequences of human drug use in a medical practice - such as failure of "expected pharmacological action," as well as accidental or intentional overdoses or abuse.
Mortality Multiple Cause-of-Death data
The Mortality Multiple Cause-of-Death database contains detailed information found in U.S. standard death certificate records from the United States and its territories. The data includes information on causes of death as well as detailed information about the deceased. Some of these details include the decedent's age, race, sex, marital status at the time of death and much more. Due to privacy reasons, names and dates of birth of the decedents are not included in this database. Specific information about the circumstances of each death is included, such as whether it was a natural death, an accident, occurred in the workplace, or was a suicide. This data traces locations by offering such details as the deceased's state of birth, state of residence as well as the state where the death occurred. Geographic information is complete for areas with population of 100,000 or more, and includes counties, cities and MSAs.
To order the data, call the Database Library at 573-884-7711 or download an order form.
Stories
To order stories from the IRE Resource Center, send e-mail to rescntr@ire.org or call us at 573-882-3364.
The impact of drug industry issues can be seen in several stories in the IRE Resource Center:
Story #17368: The Los Angeles Times follows seven drugs approved since 1993, despite misgivings inside the FDA. The drugs were later withdrawn, and the article links them to roles in 1,000 deaths.
Story #17401: CBS News tells the story of Relenza and Rezulin, and internal FDA debates over their safety and efficacy.
Story #18243: More than 100,000 patients die each year due to adverse drug reactions, according to the American Prospect. Its story examines deregulation trends and pharmaceutical companies political contributions.
Search for more stories in IRE's Resource Center.
Tipsheets
To order tipsheets from the IRE Resource Center, send e-mail to rescntr@ire.org or call us at 573-882-3364.
For more pointers on investigating these issues:
Tipsheet #2044 by Linda J. Johnson: For the Herald-Leader's series "Prescription for Pain," which covered the Oxycontin outbreak in Kentucky, the newspaper had to obtain data on the drug from multiple sources. Local, state and federal data were all necessary, and this tipsheet looks at how they obtained all their data, and what they did with it once it was in their possession. (2004)
Tipsheet #1455 provides a listing of Web sites for information about drug trials; lists sites to help track money, survivors and doctors; includes reference points to use in accountability; lists other databases available on the FDA Web site that are helpful. From Duff Wilson, Deb Nelson and David Willman on the "Investigating the Pharmaceutical Industry Here and Abroad" panel at the 2001 IRE Conference
Tipsheet #2161: "Drug data: Key data sources on prescription drug sales and marketing" from Chris Adams, Knight Ridder Washington Bureau, 2004. Adams lists sources of pharmaceutical data that include the National Ambulatory Medical Care Survey as well as data from the FDA. The background, data description and pitfalls are described for each dataset.
Tipsheet #1899 about "Covering Biotechs, Pharmas and Licensing Issues" from Mike McGraw, The Kansas City Star, includes a list of seven useful Web sites for reporters to consult while working on pharmaceutical-related stories. Also includes brief descriptions of each site.
Tipsheet #1284 compiles information on searching for pharmaceutical websites, based on a New York 2000 Conference panel of medical reporters.
Search for more tipsheets in IRE's Resource Center.
IRE Publications
The Investigative Reporter's Handbook, Brant Houston's Computer-Assisted Reporting book and other helpful publications are available from IRE and NICAR.
IRE members can search the indexes of The IRE Journal and Uplink. Back issues of The IRE Journal and Uplink may be purchased for $10 each. There is an additional $10 user fee for nonmembers. Check with the Resource Center at 573-882-3364 or rescntr@ire.org for availability.
| For more information, contact: | |
| Jeremy Milarsky Database Library Director IRE and NICAR E-mail: jeremy@ire.org Voice: 573-882-1982 Fax: 573-884-5544 |
Beth Kopine Research Director IRE Resource Center E-mail: beth@ire.org Voice: 573-882-6668 Fax: 573-884-8151 |
