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Safety For Sale…It Is Time To Demand Accountability From the FDA, and BIG PHARMA

March 5, 2009 – 11:09 pm

Its time to look at the faces of lives lost…
In the early 1990s, faced with protests by AIDS activists about the glacier-like approval of potential life saving drugs, the Clinton administration changed the FDA drug approval process. They allowed pharmaceutical companies to “fast track life-saving” drugs by absorbing the extra costs involved. The unintended consequence [...]

By H. Sandra Chevalier-Batik | Posted in Gardasil® | Comments (0)

FDA Unveils List of 20 Drugs In Side-Effect Probes

February 23, 2009 – 8:20 am

Goal Is to Provide Signs of Possibility Of Adverse Effect
By JARED A. FAVOLE
Wall Street Journal
WASHINGTON  The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.
The [...]

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

Kansas teen wants Gardasil taken off the market

February 19, 2009 – 2:32 pm

As Reported on KVUE News, Sunday February 15, 2009…
It was a hot issue here in Texas a couple of years ago.  Now Gardasil, the vaccine against the virus that causes cervical caner, is back in the spotlight.
Gabi Swank, a 16-year-old from Wichita, Kansas, says she and other girls are dying from the side-effects of the [...]

By H. Sandra Chevalier-Batik | Posted in Gardasil® | Comments (0)

Congresswoman DeLauro Questions Political Influence Over FDA

February 13, 2009 – 1:32 pm

DeLauro Seeks Info From FDA Amid Political Influence Concerns
By Jared A. Favole, Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- Congresswoman Rep. Rosa DeLauro, concerned about political influence in device and drug approvals, wants details about what products the Food and Drug Administration has approved in the last several months.
She fears that industry influence “has permeated the [...]

By H. Sandra Chevalier-Batik | Posted in Drug Approvals | Comments (0)

NVIC Says Government Denies Gardasil Risks

November 4, 2008 – 8:05 pm

Vaccine Watchdog Group Calls for Transparency
WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side [...]

By H. Sandra Chevalier-Batik | Posted in Gardasil® | Comments (0)

Supreme Court To Consider Federal Pre-Emption In Wyeth V. Levine

November 4, 2008 – 8:53 am

The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27). The case involves Diana Levine, who lost her [...]

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

Drug Web site raises important questions

October 24, 2008 – 11:50 am

By DAN RODEN, M.D. • October 10, 2008
Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine.
The Food and Drug Administration recently announced a public Web site listing potential drug [...]

By H. Sandra Chevalier-Batik | Posted in FDA Failure To Protect | Comments (0)

More Questions About Gardasil®

October 13, 2008 – 7:51 am

A Recent CNN Article lead with this headline…
Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -
Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?
A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.
Gardasil® has been the subject of [...]

By H. Sandra Chevalier-Batik | Posted in Gardasil®, STD Infection | Comments (0)

Science Experiment Likely To End Up on Your Dinner Table

September 18, 2008 – 10:22 am

FDA Releases Draft Guidance on Regulation of Genetically Engineered Animals

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On this page:

Genetic Engineering
Benefits of GE Animals
GE Animals Regulated Under New Animal Drug Provisions

The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) animals.
Although the guidance, released Sept. [...]

By H. Sandra Chevalier-Batik | Posted in FDA Failure To Protect, Follow The Money, Proactive Nutrition, Take Action!, Your Body/Your Self | Comments (0)

Merck Wins Expanded Uses for Gardasil®

September 16, 2008 – 12:09 pm

FDA News

FOR IMMEDIATE RELEASE
September 12, 2008

Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves Expanded Uses for Gardasil® to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and [...]

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