Feds Investigate Brilinta Clinical Trials
The U.S. Department of Justice as launched a probe investigating possible data manipulation in AstraZeneca’s Brilinta clinical trials, particularly the Plato trial.
Discrepancies and Possible Manipulation in Brilinta Clinical Trials
Brilinta is a blood thinner that was approved by the U.S. Food and Drug Administration in July 2011 as a preventive treatment for stroke, heart attack and blood problems.
Pharmalot reports that the data presented to the FDA in order to gain approval is now the subject of a federal investigation as an estimated 23 possible cardiovascular events or deaths were omitted or mitigated upon submission of the trial data to the FDA.
Further, while Brilinta subjects were more likely to be hospitalized after index events than patients on a competitor’s drug, Plavix, researchers failed to report the hospitalizations as primary events.
The FDA has stated that there “appears to be multiple serious deficiencies” in the clinical trial data, and that clinicians should “carefully reconsider their practice of (Brilinta) prescription for this indication.”
Details of the Plato Clinical Trials
- The Plato clinical trial enrolled 18,624 patients being treated for blocked arteries or heart attack across 46 countries.
- During the trials patients were given Plavix (Clopidogrel) or Brilinta (Ticagrelor) as part of a double blind study.
- While the results presented by researchers suggested treatment with Brilinta reduced death by stroke, heart attack and cardiovascular problems by 16 percent when compared to Plavix, the FDA and Department of Justice believe the data may not have been accurate or complete.
- Adverse events associated with Brilinta include:
- Heart Failure
- Allergic Reactions
- Renal Disorders
- Hemorrhage
- Coronary Artery Occlusion
- Death
Plato Clinical Trial Locations
- Alabama
- Birmingham
- Huntsville
- Mobile
- Arizona
- Tucson
- California
- Bakersfield
- Beverly Hills
- Burbank
- Healdsburg
- Los Angeles
- Roseville
- Sacramento
- San Diego
- Torrance
- Colorado
- Fort Collins
- Connecticut
- Danbury
- Hartford
- Delaware
- Newark
- Washington D.C.
- Florida
- Atlantis
- Daytona Beach
- Ft. Lauderdale
- Hollywood
- Jacksonville
- Jupiter
- Melbourne
- Miami Beach
- Ocala
- Orlando
- Ormond Beach
- Pensacola
- Sarasota
- St Petersburg
- Illinois
- Chicago
- Park Ridge
- Rock Island
- Rockford
- Indiana
- Indianapolis
- Muncie
- Valparaiso
- Iowa
- Iowa City
- West Des Moines
- Kansas
- Kansas City
- Olathe
- Kentucky
- Ashland
- Louisville
- Louisiana
- Shreveport
- Maine
- Auburn
- Bangor
- Maryland
- Baltimore
- Bethesda
- Salisbury
- Massachusetts
- Boston
- Springfield
- Michigan
- Ann Arbor
- Kalamazoo
- Lansing
- Laper
- Pontiac
- Royal Oak
- Saginaw
- Troy
- Ypsilanti
- Minnesota
- Duluth
- Minneapolis
- St Paul
- Mississippi
- Tupelo
- Missouri
- Columbia
- Joplin
- Kansas City
- St Louis
- Nebraska
- Lincoln
- Omaha
- Papillion
- New Jersey
- Newark
- Oakland
- Paterson
- New Mexico
- Albuquerque
- New York
- Brooklyn
- Buffalo
- Johnson City
- Kingston
- New Hartford
- New York
- Rochester
- Syracuse
- Williamsville
- North Carolina
- Chapel Hill
- Charlotte
- Greensboro
- High Point
- Raleigh
- Winston-Salem
- Ohio
- Cleveland
- Columbus
- Kettering
- Zanesville
- Oklahoma
- Oklahoma City
- Tulsa
- Oregon
- Bend
- Pennsylvania
- Camp Hill
- Danville
- Doylestown
- Harrisburg
- Lancaster
- Langhorne
- Philadelphia
- Pittsburgh
- Sayre
- Sellersville
- Wormleysburg
- York
- Rhode Island
- Providence
- Wakefield
- South Carolina
- Anderson
- Charleston
- Columbia
- Greenville
- South Dakota
- Rapid City
- Tennessee
- Jackson
- Knoxville
- Memphis
- Texas
- Amarillo
- Austin
- Dallas
- Houston
- Lubbock
- San Antonio
- San Marcos
- Tyler
- Victoria
- Vermont
- Burlington
- Virginia
- Falls Church
- Fredericksburg
- Norfolk
- Winchester
- Washington
- Everett
- Tacoma
- West Virginia
- Morgantown
- Wisconsin
- Green Bay
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.
