FDA

OIG Reports FDA Approved Drugs without Following Federal Safety Laws

Wednesday, January 14, 2009 by: Tony Isaacs
Tags: pharmaceuticals, health news, Natural News

eTrust Pro Certified

Delicious Pin It
(NaturalNews) The Office of Inspector General (OIG) has just released a damning report on the FDA`s drug approval process which provides clear evidence the FDA has approved drugs without following required legal procedures. Specifically, the Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators report.

The OIG investigation of the FDA drug approval process found that in 2007 the FDA approved numerous new drugs without complete information; specifically conflict of financial interest information of clinical trial investigators.

The Office of Inspector General, as mandated by law, is the government agency responsible for making sure the FDA is abiding by Federal law and properly following procedure and protocol to assure the safety of human and animal drugs, medical devices and foods. A critical area of oversight is making sure there have been no financial conflicts of interest such as drug companies providing stock or other financial incentives to doctors to insure that their drugs are approved and rushed to market as soon as possible.

The report from the OIG provides clear cut evidence the FDA is NOT doing that job and not following proper protocol required by Federal law.

Here are some of the findings:

Only one percent of clinical investigators disclose a financial interest.

42 percent of FDA-approved marketing applications were missing financial disclosures. Companies are required to disclose any financial interests with the companies they are conducting trials for, but the HHS report found that in 42 percent of the trials, the FDA did not receive the required forms.

23% of 2007`s approved drugs and approved medical devices were missing required attachments.

31% of the 2007 FDA approved drugs and approved medical devices showed the FDA did not document any financial information.


When there were financial conflicts, in 20 percent of applications, the FDA reviewers did not take action.

In 1999, the FDA required drug and device makers to divulge any conflicting interests with doctors who oversee patients involved in clinical trials. The companies are supposed to disclose that information to the FDA, but the inspector general found there was almost no enforcement of those rules. The new report clearly shows that the The Food and Drug Administration (FDA) continue to have a hands-off policy over conflicts.

The New York Times reported that the FDA admitted that the efforts to try and protect patients from such conflicts is, "not worth the effort". FDA spokeswoman Karen Riley offered up the lame excuse that the agency opposed reviewing doctors` financial conflicts before trials because they represented just one possible source of bias.

Conflicting interests between drug companies and researchers conducting clinical drug/device trials is a story that makes the headlines almost weekly, especially since the research generated often dictates the prescriptions doctors write nationwide. The new federal inquiry feeds a growing debate and sense of outrage over the FDA`s cozy relationship with the drug companies it is supposed to oversee and about how money that doctors collect from drug and device makers may hurt patients and skew studies.

The Department of Health and Human Services (HHS) inspector general report issued Monday reviewed 118 clinical trials marketing applications approved by the FDA in 2007.

To read the full Inspector General report: http://www.oig.hhs.gov/oei/reports/oei-05-07...

Sources included:

The Office of Inspector General
The NY Times


About the author

Tony Isaacs, is a natural health author, advocate and researcher who hosts The Best Years in Life website for those who wish to avoid prescription drugs and mainstream managed illness and live longer, healthier and happier lives naturally. Mr. Isaacs is the author of books and articles about natural health, longevity and beating cancer including "Cancer's Natural Enemy" and is working on a major book project due to be published later this year. He is also a contributing author for the worldwide advocacy group "S.A N.E.Vax. Inc" which endeavors to uncover the truth about HPV vaccine dangers.
Mr. Isaacs is currently residing in scenic East Texas and frequently commutes to the even more scenic Texas hill country near Austin and San Antonio to give lectures and health seminars. He also hosts the CureZone "Ask Tony Isaacs - featuring Luella May" forum as well as the Yahoo Health Group "Oleander Soup" and he serves as a consultant to the "Utopia Silver Supplement Company".

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.