the FDA

Conflicts of interest at the FDA are rampant and largely ignored

Friday, January 05, 2007 by: Dani Veracity
Tags: conflicts of interest, FDA corruption, pharma corruption

eTrust Pro Certified

Delicious Pin It
Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA's drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants rarely step down because of them. If a new conflict-of-interest amendment by Congressman Maurice Hinchey, D-NY, goes through, this will soon change for the better.

The foundation of the American drug approval process is theoretically objective science; however, the very nature of the process often allows subjectivity to come into play. In order for a new pharmaceutical to be approved by the FDA, the Center for Drug Evaluation and Research (CDER) looks at the pre-approval clinical trials paid for by the drug's maker and determines whether the drug is safe and effective. This is done at a rate of 25 to 30 new pharmaceutical drugs per year, according to Public Citizen.

The CDER often relies on advice from external advisory committee members and voting consultants, who are invited by the FDA to make the decisions. According to Public Citizen, this is where the problem is. In September 2001, Public Citizen threatened to sue the FDA and force it to disclose detailed information about committee members' financial interests. This is by no means an uncommon request. According to current conflict-of-interest law, politicians and high-ranking government officials are routinely required to disclose financial holdings.

In January 2002, the FDA responded to the problem by setting new guidelines for committee members. As of the beginning of 2002, all committee members and voting consultants are required to publicly disclose more detailed financial conflict-of-interest information at the beginning of advisory meetings. In theory, this should have solved the drug evaluation process' conflict-of-interest problems, but it did not.

The Public Citizen study examined all of members' disclosed conflicts from 2001 to 2004, a time range carefully set to include one year before the January 2002 guidelines took effect, and three years after the onset of the new guidelines. By looking at this period of time, Public Citizen could determine whether the January 2002 guidelines have effectively lessened conflicts of interest among the committee members who decided whether a new pharmaceutical drug "makes the grade."

From 2001 to 2004, 28 percent of voting consultants and advisory committee members had conflict of interest, and at least one consultant or member had conflict of interest in 73 percent of all drug approval meetings. This means that, at least 73 percent of the time, new pharmaceutical drugs weren't entirely objectively approved by the FDA because at least one person in power possibly had an external financial motive. Ethically speaking, someone with conflict of interest is expected to recuse himself or herself, or step down from, any and all decisions where that conflict of interest exists. Unfortunately, according to the Public Citizen study, only one percent of members with conflicts of interest actually abstained from attending the meeting in question. Such a low percentage is inexcusable.

Furthermore, this conflict doesn't involve small change. The same study that discovered the epidemic nature of the conflict of interest found that 19 percent of consulting arrangements were over $10,000; 30 percent of investments were worth over $25,000; and 23 percent of contracts or grants equaled sums over $100,000.

These sums are too large to ignore. "Conflicts of these magnitudes should result in automatic recusal from advisory committee meetings," says Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group. "With as many highly qualified professionals as we have in this country, there should be little difficulty identifying members with more limited or, ideally, no conflicts of interest."

The conflict of interest doesn't end with the committee members and the voting consultants. Even the public speakers that the committee members and voting consultants listen to in order to make their decisions are under the influence of Big Pharma. In fact, they're often supported by and sometimes provided travel by the very pharmaceutical company that makes the drug under review.

However, the question is whether this widespread conflict of interest affects the behavior of the committee members, voting consultants and public speakers. Ironically, the study found that the public speakers supported by the drug companies are more likely to disclose conflict than voting consultants and committee members. It also found that, in the words of Public Citizen, "For every voting member with a conflict of any type (index drug or competitor drug), there was a 10 percent greater likelihood that the meeting would favor the drug being considered."

A sway of even 10 percent is too much. Dr. Lurie believes that the external committee members and voting consultants who advise the CDER during new drug trials should be held to the same standards as the jurors in high-profile legal trials. "If a juror is found to have so much as read a newspaper, he or she can be dismissed in certain trials," he explains. "We should have zero tolerance for accepting levels of conflict that would have even a small impact upon voting outcome, but in our study we found such impacts. What we need is not simply disclosure of conflicts, but also greater efforts to identify members without conflicts."

On May 9 of 2006, less than two weeks after the Public Citizen study was published in the April 26 issue of JAMA, the House Appropriations Committee approved Rep. Hinchey's proposed amendment to the Agriculture, Rural Development, FDA and Related Agencies Appropriations bill for Fiscal Year 2007.

"Plain and simple, if a doctor or scientist has a personal, financial stake in a drug, they should not be allowed to sit on an FDA advisory panel and determine whether that drug is safe," Hinchey explains of the amendment that popularly bears his name. "This amendment puts an end to the FDA's rampant use of waivers for advisory panels that have for far too long endangered the safety of the American people. Now that this measure is in the House bill, it will take a lot of work to ensure that it stays in all the way until it becomes law, but I am confident that we can succeed."

The success of this amendment affects everyone who has ever used a prescription. Drugs should be approved on basis of science alone, not the financial interests of people in power.

###

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.