CHICAGO (Reuters) - a group of U.S. consumers alleged Tuesday that researchers with ties to Eli Lilly and Co withheld important information of a medical journal in their study of a drug of Imaging for Alzheimer's disease.
In a letter published in the Journal of the American Medical Association, Public Citizen criticized a study on 19 January that assessed the effectiveness of the scans of the brain to help Lilly Amyvid, dye experimental to detect abnormalities of the brain.
They said that the authors of the study excluded data on how accurately the scans have been interpreted by a doctor to another.
"Conceal important information, were induced the newspaper and its readers to believe that this test to identify abnormalities of the brain was more reliable than it actually is," Dr. Michael Carome, Director Assistant of the Public Citizen health research groupwritten.
"Given what you know of Alzheimer's disease and the lack of effective treatments, no test for the diagnosis of this disease must be proved to be very precise in studies of large, carefully before it is approved by the FDA for marketing"carome."said."
Lilly strongly dispute their claims, calling it "inaccurate."
"We have worked with the FDA to identify and specify all end points for the study of Phase III of Amyvid", the company said in a news release.
Lilly said all points of termination in the study have been met, and they have "communicated adequately."
In March, the U.S. Food and Drug Administration refused to approve Amyvid, citing the need to ensure the scans can be read accurately.
An Advisory Committee of the FDA said in January that it would take more data before approval.
Amyvid is designed to detect the plate of beta-amyloid associated with Alzheimer's disease in the brains of people living on a procedure for imaging called a computed tomography scan pet (pet).
A non-reliable test could lead some people to believe that they had Alzheimer's disease when they are not, and it could be others the false assurance that the did not have the disease, when they could, Public Citizen, said in an e-mail.
Lilly is to research the agent for use with pet market, to help doctors rule on the plate related to Alzheimer's disease, but do not to diagnose disease.
General Electric, and Bayer AG also develop rival products.
Lilly and his unit of Avid Radiopharmaceuticals have said they are trying to answer the questions raised by the FDA Advisory Committee and will continue to do so in an ongoing dialogue.
Currently, some 26 million people globally have Alzheimer's disease, the most common dementia form.
(Reported by Julie Steenhuysen.) (Editing by Laura MacInnis and Paul Simao)
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