drug

Children as Big Pharma Guinea Pigs: 98 Percent of Drug Trials on Children Have no Safety Checks

Monday, August 18, 2008 by: David Gutierrez, staff writer
Tags: drug trials, health news, Natural News

eTrust Pro Certified

Delicious Pin It
(NaturalNews) Fewer than 2 percent of drug trials conducted on children have independent safety advisory boards, a review published in the journal Acta Paediatrica has found.

Researchers from Nottingham University reviewed reports on 739 international drug trials that had been published between 1996 and 2002. They found that although 74 percent of studies described their safety monitoring procedures, less than 2 percent included an independent safety review committee.

Such committees are composed of independent health experts who can review the study data as it comes out and warn if the drug appears to be placing study participants at risk.

"It is invaluable to have an independent monitor who can swiftly question any adverse drug reactions or differences in illness and death rates between groups taking part in the clinical trials," said lead researcher Helen Sammons. "Parents also need to be made aware of the risks of adverse drug reactions when a child takes any medicine so that they can make informed decisions that balance those risks against the possible benefits the drug may provide their child."

The Nottingham University review also suggests that independent committees lead to more rigorous safety standards. Of the 13 studies with independent review committees, six were halted early due to highly toxic drug effects.

None of the studies without independent committees were stopped early.

Although the researchers looked only at studies conducted on children, they said the statistics for adult trials are probably similar.

"There is general agreement by pediatric health professionals, regulatory authorities and the pharmaceutical industry, as well as politicians and parents, that drug trials are essential in order to improve drug therapies," Sammons said. "We are calling for all pediatric drug trials to include independent safety monitoring committees to ensure that this vital work is carried out in a way that minimizes risks and maximizes benefits for the children taking part."

Adverse health effects were reported in the majority of drug trials, although not all of them were thought to be related to the drugs. A total of 70 percent of drug trials reviewed reported adverse effects, and 20 percent reported serious adverse effects. Almost 37 percent of drug trials reported side effects attributed to the drugs; 11 percent of trials reported moderate, severe or life-threatening side effects.

Adverse effects reported included bleeding, high blood pressure, seizures, psychosis, acute renal failure and suicide.

Deaths were reported in 11 percent of drug trials, particularly in those involving premature babies. A total of 56 percent of studies involving newborns involved deaths. Deaths were also reported in trials for drugs meant to treat infectious diseases and problems with the nervous system, respiratory system and kidneys.

Most cases of death were not thought to be caused by the drugs.

According to Sammons, the practice of conducting clinical drug trials on children is fairly new. In the past, drug companies only conducted safety tests on adults and doctors were left to guess at what drugs would work for children, and in what doses.

Five years ago, the United States began providing longer exclusive drug licenses to pharmaceutical companies that carry out drug trials on children as well as adults. In reaction to this incentive, the number of trials including children has increased. A similar incentive system is about to go into effect in the European Union.

It is important to conduct these trials, Sammons said, to decide if the benefits of drugs outweigh the risks.

"We need to test drugs on children, as the only other options are to use unlicensed drugs or prescribe drugs that have been licensed for adults," Sammons said. "But we feel that the small number of studies that reported having safety monitoring committees was unacceptable."

Get breaking news alerts on GMOs, fluoride, superfoods, natural cures and more...
Join over four million monthly readers. Email privacy 100% protected. Unsubscribe at any time.


Have comments on this article? Post them here:

comments powered by Disqus

Take Action: Support NaturalNews.com

Email this article to a friend

Permalink to this article:

Reprinting this article: Non-commercial use OK, cite NaturalNews.com with clickable link.

Embed article link: (copy HTML code below):
Most Popular
Today | Week | Month | Year

See all Top Headlines...



GET SHOW DETAILS
+ a FREE GIFT

Now Available at ShopNaturalNews.com

O3 Essentials OraJuvenate™
A powerful, cleansing dental cream for maximum oral/dental health.
New Cancer Solutions
Over 3 hours of content covering today’s best cancer tests, how to kill cancer cells and the best diets and exercise routines.
Freeze-Dried 100% Organic Whole Corn
Our freeze-drying method preserves taste, texture and nutrients better than any other food preservation method ever invented.
Fenix TK35 Flashlight
Tough, waterproof, extremely bright and it’s touted to throw an 800+ lumen beam more than 1,000 feet into the night.
Inca Treasure Smoothie Pack
This pack of our four most popular superfoods from South America is the perfect combo pack for smoothie lovers.
Pink Himalayan Salt
This salt delivers significant levels of magnesium, zinc and selenium, with trace levels of dozens of other elements.
Pinhole Glasses - Aviator Style
Pinhole glasses are becoming famous for helping people improve their vision without the risks of laser surgery.
Oxy-Rich Facial Serum
O3 Essentials Jojoba Oxy-Rich Facial Serum is cellular nourishment for your skin. Helps smooth fine lines while enhancing tissue elasticity.
Freeze-Dried 100% Blackberry Halves
Our freeze-dried blackberry halves are grown in Serbia under strict organic standards.

Also on NaturalNews:

Health Ranger Videos
Activist music
CounterThink Cartoons
Food documentaries
FREE Special Reports
Podcasts
Colloidal Silver

Advertise with NaturalNews...

Support NaturalNews Sponsors:

Advertise with NaturalNews...

Most Popular Stories

Flu shot kills 19-year-old, but vaccine industry still has total immunity against lawsuits
Here's a nutty fact: Eating more tree nuts lowers the risk of all-cause death by up to 20 percent
Six important facts you're not being told about lost Malaysia Airlines Flight 370
Malaysia Airlines Flight 370 now clearly a government cover-up: All evidence contradicts official story
10 other companies that use the same Subway yoga mat chemical in their buns
BLM fracking racket exposed! Armed siege and cattle theft from Bundy ranch really about fracking leases
High-dose vitamin C injections shown to annihilate cancer
U.S. treating meat with ammonia, bleach and antibiotics to kill the '24-hour sickness'
USDA to allow U.S. to be overrun with contaminated chicken from China
Vaccine fraud exposed: Measles and mumps making a huge comeback because vaccines are designed to fail, say Merck virologists
Battle for humanity nearly lost: global food supply deliberately engineered to end life, not nourish it
Diet soda, aspartame linked to premature deaths in women

25 Amazing Facts About Food

This FREE downloadable report unveils a collection of astonishing and little-known facts about the food we eat very day. Click here to read it now...

 

Resveratrol and its Effects on Human Health and Longevity - Myth or Miracle.

Unlock the secrets of cellular health with the "miracle" nutrient Resveratrol Click here to read it now...

 

Nutrition Can Save America

FREE online report shows how we can save America through a nutrition health care revolution. "Eating healthy is patriotic!" Click here to read it now...

The Healing Power of Sunlight and Vitamin D

In this exclusive interview, Dr. Michael Holick reveals fascinating facts on how vitamin D is created and used in the human body to ward off chronic diseases like cancer, osteoporosis, mental disorders and more. Click here to read it now...

Vaccines: Get the Full Story

The International Medical Council on Vaccination has released, exclusively through NaturalNews.com, a groundbreaking document containing the signatures of physicians, brain surgeons and professors, all of which have signed on to a document stating that vaccines pose a significant risk of harm to the health of children. Click here to read it now...

Health Ranger Storable Organics

GMO-free, chemical-free foods and superfoods for long-term storage and preparedness. See selection at www.StorableOrganics.com



Recommended Resources On:

Natural News trends
Health Ranger news
Natural News GMOs
Mike Adams tracker
Natural News photos
Natural News Global
Natural News in focus
Natural News connect
Natural News shocking stories
Natural News radar
GMOs
Quackwatch
Vaccines
Health freedom
Dr. Paul Offit

This site is part of the Natural News Network © 2014 All Rights Reserved. Privacy | Terms All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing International, LTD. is not responsible for content written by contributing authors. The information on this site is provided for educational and entertainment purposes only. It is not intended as a substitute for professional advice of any kind. Truth Publishing assumes no responsibility for the use or misuse of this material. Your use of this website indicates your agreement to these terms and those published here. All trademarks, registered trademarks and servicemarks mentioned on this site are the property of their respective owners.

eTrust Pro Certified Android app on Google Play

Sign up for the FREE Natural News Email Newsletter

Receive breaking news on GMOs, vaccines, fluoride, radiation protection, natural cures, food safety alerts and interviews with the world's top experts on natural health and more.

Join over 7 million monthly readers of NaturalNews.com, the internet's No. 1 natural health news site. (Source: Alexa.com)

Your email address *

Please enter the code you see above*

No Thanks

Already have it and love it!

Natural News supports and helps fund these organizations:

* Required. Once you click submit, we will send you an email asking you to confirm your free registration. Your privacy is assured and your information is kept confidential. You may unsubscribe at anytime.