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category archive listing Category Archives: FDA Clinical Trials

Researchers Question Wide Use of HPV Vaccines

August 21, 2008 – 1:04 pm
Posted by H. Sandra Chevalier-Batik

FINALLY!
In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, Cancer Research, Cervical Cancer, FDA Failure To Protect, Follow The Money, HPV Infection, HPV Vaccine, Take Action! | Comments (0)

Your Guide to Reporting Problems to FDA

June 12, 2008 – 11:19 am
Posted by H. Sandra Chevalier-Batik

Reporting any adverse events (unexpected side effects) to FDA after using a medical product, or other problems with any products that the agency regulates.

Printer-friendly PDF (366 KB)

On this page:

Tips for Reporting
Quick-Reference Chart for Reporting Problems to FDA
Types of Problems FDA Doesn’t Handle

Consumers play an important public health role by reporting to the Food and Drug [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch | Comments (0)

FDA 101:

June 10, 2008 – 2:46 pm
Posted by H. Sandra Chevalier-Batik

How to Use the Consumer Complaint System and MedWatch

On this page:

Consumer Complaint Reporting
Reporting Problems Can Spur Action
MedWatch Reporting
How to Report to MedWatch
Problems to Report to MedWatch
Reporting Emergencies
FDA Consumer Complaint Coordinators (regions and telephone numbers)

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear [...]

By H. Sandra Chevalier-Batik | Also posted in Take Action! | Comments (0)

The FDA Fails To Protect Patient Rights

June 7, 2008 – 7:21 am
Posted by H. Sandra Chevalier-Batik

The Food and Drug Administration should rethink its rejection of the Declaration of Helsinki.
Later this year, the US Food and Drug Administration (FDA) will adopt new standards for human clinical trials conducted without its advance sign-off in foreign countries. The rules will govern whether data from such trials can be used in applications to market [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, FDA Failure To Protect, Follow The Money | Comments (0)

Surgery Beta Blockers ‘Up Risk’

May 15, 2008 – 6:23 am
Posted by H. Sandra Chevalier-Batik

The use of beta blocker drugs before surgery to cut the risk of heart problems may be counter-productive, a study suggests.
 
Researchers found patients given the drugs were a third more likely to die within a month of surgery than those given a dummy pill.
Those on the blood pressure-lowering drugs also had double the risk [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, Uncategorized | Comments (0)

A Guide to Drug Safety Terms at FDA

April 11, 2008 – 10:29 am
Posted by H. Sandra Chevalier-Batik

Inconvenient Woman readers know that I’m not an FDA fan.
In my opinion, the troubled agency’s close ties and financial dependence on Big Pharma
has been weakened its ability to perform its primary function — protecting the public. The FDA’s documented failure to impartially judge the veracity of drug trial results and enforce safety oversight of the [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch | Comments (0)

There is A New Book in the Iconic Woman Bookshelf…

April 9, 2008 – 9:24 am
Posted by H. Sandra Chevalier-Batik

The Secret History of the War on Cancer
By Devra Davis, PhD, MPH
Review by Leslie Botha, Holy Hormones Honey!
In a recent interview on CSPAN Davis stated, “For much of its history, the cancer war has been fighting the wrong battles, with the wrong weapons, against the wrong enemies.”

The Secret History of the War on Cancer by [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, Breast Cancer, Cancer Research, Cervical Cancer, Follow The Money, HPV Infection, HRT, PAP Test, Proactive Nutrition, STD Infection | Comments (0)

Vytorin — Another FDA Failure To Protect Public

April 8, 2008 – 10:12 am
Posted by H. Sandra Chevalier-Batik

Big Pharma Giants Schering and Merck
Take Heavy Criticism Over Vytorin Failure
This week Merck executives are very grateful for the revenue predictions for their blockbuster HPV vaccine, GARDASIL. Profits are predicted to climb from $300 million to $4 billion over the next year. After the Vytorin debacle —they’re going to need the cash.
So lock up your [...]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, Follow The Money | Comments (0)

Who is Bankrolling the FDA and Why?

July 20, 2006 – 9:02 am
Posted by H. Sandra Chevalier-Batik

There has been no increase in congressional appropriations to the FDA from fiscal years 1986 through 2006. (1)
FDA’s Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The [...]

By H. Sandra Chevalier-Batik | Comments (0)

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials

June 26, 2006 – 1:38 pm
Posted by H. Sandra Chevalier-Batik

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring
The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency’s oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency’s approach [...]

By H. Sandra Chevalier-Batik | Comments (0)