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Merck Has A History of Producing Contaminated Vaccine Product

April 22, 2009 – 9:52 pm

The issues discussed in the 1987 filmed interview of Merck’s chief vaccine researcher, Dr Maurice Hilleman, conducted by Dr. Edward Shorter, Professor of the History of Medicine and Professor of Psychiatry, University of Toronto raise serious doubts about the propaganda the public has been fed about the safety of Merck vaccines. Vaccines that have been promoted as “safe and effective” miraculous cures have been infecting (possibly) millions of people with cancer, leukemia, and AIDS.

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

Can Glaxo learn from Merck

March 29, 2009 – 7:34 am

As Glaxo is forced to wait for FDA’s approval for its own HPV vaccine, Cervarix, will the company use its time on the sidelines to absorb lessons learned from Merck’s missteps? There is a building backlash against Merck’s ‘BIG-FOOT’, political lobbing strategy that aggressively pushes politicians to mandate its vaccine. Merck has pushed through from one political firestorm to the next. An increasing resentful public is feeling like Atlanta to Merck’s Sherman-like march to market share.

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

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)

Sen. Grassley (R-IA) Keeps Pharmaceutical Industry, FDA In The Crosshairs

February 16, 2009 – 12:00 pm

A BIG thank you to the Philadelphia Inquirer…
One of the few major media outlets that consistently cover Big Pharma and the FDA…
This weekend The Philadelphia Inquirer examined how Sen. Chuck Grassley (R-Iowa) has “found a congressional calling” in “creating uproars that often transform public opinion and policy” and “in recent years … has repeatedly turned [...]

By H. Sandra Chevalier-Batik | Posted in Big Pharma Watch, FDA Failure To Protect | 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)

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)

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)

September 12, 2008 – 9:52 pm

FDA Consumer Update addressing recent, questions about the safety of Gardasil, a HPV-vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.

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

FDA Thwarts Merck’s Expanded Use of Gardasil, For Now

June 25, 2008 – 8:19 am

The FDA rejected Merck’s request to approve its HPV vaccine, Gardasil for women between ages 27 and 45, citing “issues that preclude approval within the expected review timeframe,” Merck offered no additional specific explanation in their prepared statement. Merck indicated that it is in ongoing discussions with FDA officials about to the application and expects to officially respond to the agency within the next 30-days. The HPV- vaccine, Gardasil, was approved June 8, 2006 for girls and women between 9 and 26 years old to prevent human papillomarivus related cervical cancer.

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

FDA 101:

June 10, 2008 – 2:46 pm

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 | Posted in FDA Clinical Trials, Take Action! | Comments (0)
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