login
Become a member
Quick Registration
Full Registration Benefits -
Free Homepages for Doctors
Free Homepages for Hospitals
Free Homepages for Medical Conference
Free Homepages for NGO's
Personal Health Record Creation
Access to all Medical Slides
Access to all Jobs & Products Sale
Standards Need to be More Strict for Drugs Up for FDA Approval
Alec B. O'Connor, M.D., M.P.H., associate professor in the Hospital Medicine Division of the Department of Medicine, says that while the U.S. Food and Drug Administration does an "incredible job, considering its long list of responsibilities and budget constraints," the agency should be empowered to demand more detailed data when a new drug is being considered for approval.
O'Connor's main point is that the FDA should require studies comparing the effectiveness and safety of a new drug to an established first-line drug when considering a drug for approval. Currently the agency does not require such studies, known as "active comparator trials," though some large studies of new drugs do include them. In many cases, to gain approval, the main criterion besides safety is that a new drug must be shown to be more effective than placebo.
"When new medications have been compared only to placebo, not to drugs already on the market, it's very difficult to know whether and how we should prescribe them to patients," O'Connor said. "For example, if a new medication to treat depression is approved based only on placebo comparisons, it's very difficult to know how the new drug compares with the dozens of medications already approved for depression. Faced with the extensive and very successful marketing undertaken by the drug manufacturer, oftentimes physicians will assume that the newer drug is more effective or has important advantages over older treatments, even though there may be no evidence showing that to be so."
|
|
|
More News on: Drug Toxicity, Drugs Banned in India
 Comment & Contribute
|
Medwonders Health Network
- Health News Index
- News Quick Links
| News Categories: |
| » | Schizophrenia Drug Differentiates Cancer Stem Cells into Less Threatening Cells |
| » | Docs Who Seldom Meet Drug Reps Continue to Prescribe Drugs With FDA “Black Box” Warnings |
| » | Revision in Quality Standards for Heparin |
| » | Acne Drug Users At High Risk of Developing Eye Infections |
| » | Patients Who Take Antidepressants When in ICU More Likely to Die |
| More Drug News | |
|
