About Careers Internship MedBlog 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
 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
Font : A-A+

Advertisement

Advertisement
Advertisement

Recommended Readings

Latest Drug News

Projected Growth: Psychedelic Drug Market Anticipated to Hit $7.2 Billion by 2029
The psychedelic market set for remarkable growth, projected to hit $7.2B by 2029 with a strong 55% CAGR.
Promising ALS Drug Candidate Extends Lifespan
The study explores whether CDNF could influence the progression of ALS in rodent models and to elucidate the mechanism through which it operates.
Amoxicillin-Calvulanate Vs Amoxicillin Preference in Child Sinusitis Treatment
Amoxicillin-clavulanate use in acute sinusitis patients is associated with a higher incidence of adverse events.
ADHD Medication Errors Surge by Nearly 300%
Professionals advocate for enhanced education of patients and caregivers, and creation of more effective child-resistant systems for monitoring ADHD medication.
Unknown Medication Side Effects Reported by 52% of Indian Families
In June, WHO raised concerns about 7 Indian cough syrups after complaints from several countries about contamination and health issues.
View All
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  Ok, Got it. Close
MediBotMediBot
Greetings! How can I assist you?MediBot
×

Report Says Fatal Flaws in Drug Testing may Up Side Effects Risk Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests