FDA Rules Override Warnings About Drug
Cattle Antibiotic Moves Forward Despite Fears of Human Risk
By Rick Weiss
Washington Post Staff Writer
Sunday, March 4, 2007; Page A01
The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.
The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people."The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."
WTF does this mean - "direct link to human mortality?" It means that until some one or some many die, they will use this product on cattle, which we will then eat! Bayer pushed for this and won! Show me the money!!
Mar 10, 2007
This is the Kind of Shit That Pisses Me Off!
Dec 22, 2006
FOR IMMEDIATE RELEASE 06-123 August 30, 2006
Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Warns Consumers Not to Buy or Use Prescription Drugsfrom Various Canadian Websites that Apparently Sell Counterfeit Products
The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.
FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.
DRUG NAME
USE(S)
LIPITOR
Cholesterol disorders
CRESTOR
Cholesterol disorders
ZETIA (US name) / EZETROL (Canadian name)
Cholesterol disorders
DIOVAN
High blood pressure
HYZAAR
High blood pressure
ACTONEL
Osteoporosis in postmenopausal women
NEXIUM
Gastroesophageal reflux disease (GERD)
CELEBREX
Arthritis-related pain
ARIMIDEX
Breast cancer
PROPECIA
Male-pattern baldness
Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are:
www.RxNorth.com;
www.Canadiandrugstore.com;
www.Rxbyfax.com;
www.Northcountryrx.com;
www.Canada-pharmacy.com;
www.My-canada-pharmacy.com;
www.NLRX.com;
www.Canampharmacy.com;
www.Canada-Meds-For-Less.net; and
www.Canadian-safe.com
As a general matter, FDA advises consumers to use caution when buying medical products online. Although a website may appear reputable and similar to legitimate retail pharmacy websites, many actually operate from outside the U.S. and provide unapproved drugs from unreliable sources.
For example, in August of 2005, FDA conducted an operation at New York, Miami, and Los Angeles airports which found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with “Canadian pharmacies.” Of the drugs being promoted as “Canadian,” based on accompanying documentation, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit. These results demonstrated that some Internet sites that claimed to be “Canadian” were, in fact, selling drugs of dubious origin, safety and efficacy.
Today’s announcement is consistent with FDA’s earlier message of the dangers posed by such websites and the need for caution on behalf of the public. Drug counterfeiting is illegal for good reason. Drug counterfeiting defrauds consumers and can expose them to products containing unknown, ineffective, or harmful ingredients. Counterfeit drugs may be toxic or contain doses that are too small to treat a medical condition, or so large that they could endanger the health of the user. Because of the dangers posed by counterfeit drugs, the FDA aggressively investigates all instances of drug counterfeiting.
www.fda.gov/counterfeit/.
