Approval of a tuberculosis drug based on a paradoxical surrogate measure

JAMA

Volumn 309, Issue 13, 2013, Pages 1349-1350

  Avorn, Jerry ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEDAQUILINE; EZETIMIBE; EZETIMIBE PLUS SIMVASTATIN; HEMOGLOBIN A1C; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; PROTON TRANSPORTING ADENOSINE TRIPHOSPHATASE; ROSIGLITAZONE; SIRTURO; UNCLASSIFIED DRUG;

CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; DIABETES MELLITUS; DRUG APPROVAL; DRUG EFFICACY; DRUG MECHANISM; DRUG TREATMENT FAILURE; ENZYME INHIBITION; HEART INFARCTION; HEART VENTRICLE FIBRILLATION; HEMOGLOBIN BLOOD LEVEL; HIGH RISK PATIENT; HUMAN; HYPERCHOLESTEROLEMIA; LIVER TOXICITY; MULTIDRUG RESISTANT TUBERCULOSIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QT PROLONGATION; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY; SPUTUM CULTURE;

EID: 84875639613     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2013.623     Document Type: Short Survey

References (8)

1. US Food and Drug Administration. Briefing Package: NDA 204-384: Sirturo. US Food and Drug Administration website. http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti- %20InfectiveDrugsAdvisoryCommittee/UCM329258.pdf. November 28, 2012. Accessed January 7, 2013.
2. Janssen Briefing Document: TMC207 (bedaquiline): Treatment of Patients with MDR-TB: NDA 204-384. US Food and Drug Administration website. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/Anti-%20InfectiveDrugsAdvisoryCommittee/UCM329260.pdf. November 28, 2012. Accessed January 7, 2013.
3. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med. 2008;358(13):1354-1361. (Pubitemid 351468412)
4. Hirschler B, Humer C. FDA new drug approvals hit 16-year high in 2012. Reuters website. http://www.reuters.com/article/2012/12/31/us-pharmaceuticals- fda-approvals-idUSBRE8BU0EK20121231. December 31, 2012. Accessed January 15, 2013.
5. Cox EM. FDA accelerated approval letter to Janssen Research and Development. US Food and Drug Administration website. http://www.accessdata.fda. gov/drugsatfda-docs/appletter/2012/204384Orig1s000ltr.pdf. December 28, 2012. Accessed January 16, 2013.
6. Carome MA, Wolfe SM. Letter to Janet Woodcock and John Farley. Public Citizen website. http://www.citizen.org/documents/2088.pdf. December 21, 2012. Accessed January 7, 2013.
7. Ridley DB, Grabowski HG, Moe JL. Developing drugs for developing countries. Health Aff (Millwood). 2006;25(2):313-324. (Pubitemid 43529539)
8. Kesselheim AS. Drug development for neglected diseases - the trouble with FDA review vouchers. N Engl J Med. 2008;359(19):1981-1983.