About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Report Says Fatal Flaws in Drug Testing may Up Side Effects Risk

by Rajashri on August 6, 2008 at 3:02 PM
Font : A-A+

 Report Says Fatal Flaws in Drug Testing may Up Side Effects Risk

An American sociologist says that there are fatal flaws in the way new drugs are tested and marketed these days.

"Drug disasters are literally built into the current system of drug testing and approvals in the United States. Recent changes in the system have only increased the proportion of new drugs with serious risks," said Donald Light, the sociologist who authored the study and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey.

Advertisement

According to a 1999 report for the Institute of Medicine, adverse drug reactions (ADRs) can occur for a number of reasons, including improper prescribed dosage, drug abuse and drug interactions.

This study has found the organizational basis of patient risk from prescription drugs, and suggests institutional reforms to help avoid or reduce future drug disasters.
Advertisement

Lights said that the existing testing system evaluates the effectiveness of new drugs based on their effects compared to placebos, instead of using current approved drugs as benchmarks of efficacy.

Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.

This made Light to say that new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs.

Light's analysis suggests another flaw lies within the design of clinical trials, as they are conceptualized with an aim to minimize evidence of toxic side effects. For this pharmaceutical companies sample from a healthier population atypical of patients who will actually take the drug, excluding people who are older, poorer or who have multiple health problems.

Trials are run long enough to pick up main effects but not to detect some long term side effects. As approvals are based on these data, thus drugs with harmful effects sometimes get through.

"Based on our current system, the designation of 'safe and effective' on today's new drugs could be replaced with, 'apparently safe based on incomplete information, and more effective than a placebo,'" said Light.

The study will be presented at the annual meeting of the American Sociological Association (ASA).

Source: ANI
RAS/L
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Advertisement
News Category
What's New on Medindia
International Day of Persons with Disabilities 2021 - Fighting for Rights in the Post-COVID Era
Effect of Blood Group Type on COVID-19 Risk and Severity
Woman with Rare Spinal Cord Defect from Birth Sues Doctor
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Signature Drug Toxicity 

Recommended Reading
Chemotherapy
'Chemo' means medicine or 'drug'; 'therapy' means 'treatment'. Chemotherapy refers to the use of .....
Chemotherapy Drugs
Chemotherapy drugs perform like 'magic bullets' to destroy cancer cells in the body....
Interaction Between Antidepressant Drugs, Cocaine and Brain Cells Identified
A team of researchers from Weill Cornell Medical College and Columbia University Medical Center has ...
A Suicidal Child can Be Known by His Music Tastes
Doctors can determine whether a teenager is at the risk of developing a mental illness or ......
Drug Toxicity
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a d...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2021

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use