UN officials are establishing the first pharmaceutical standards for medicines used in treating African farm animals.[...]
In the wake of cancer clinic scandal involving counterfeit Avastin, a vital medication that breast cancer, lung cancer and colorectal cancer patients take to cut off the blood supply to tumors, new research shows that Avastin may be more vital than ever when used in conjunction with a medication which prevents the cancer from spreading…[...]
A week after the US Food and Drug Administration notified 19 clinical medical practices that the Avastin with which they were treating cancer patients was counterfeit and contained no active ingredient, the Health Ministry of Israel announced a shipment of Avastin bearing an identical number to a batch identified as fake was sold in Israel…[...]
View larger map In an FDA report unsealed February 16th, La Jolla CA businessman, James R. Newcomb has pled guilty on charges of conspiracy to cause the introduction of adulterated prescription drugs into interstate commerce. Newcomb’s business, Ban Dune Marketing Inc (BDMI) of La Jolla, CA. has been named as a source of the counterfeit…[...]
This is a reprint of the Company Safety Recall posted on the FDA website. February 22, 2012 – Healthy People Co. announced today that is expanding its voluntary nationwide recall of the company’s dietary supplements sold under the brand names described below, regardless of the lot numbers referenced herein, and to the extent these products were…[...]
View larger map In an FDA report unsealed February 16th, Saint Louis, MO oncologist, Dr. Abid S. Nisar has pled guilty on charges of distributing and receiving misbranded and adulterated prescription drugs, including the cancer treatment drugs marketed in the United States as Neupogen®, Herceptin® and Rituxan®. Nisar purchased the counterfeit cancer from Ban Dune…[...]
Patients can take measures to protect themselves against counterfeit medications, says Connie Jung from the Office of Drug Security, Integrity and Recall of the U.S. Food and Drug Administration. Speaking at the 2011 Partnership for Safe Medicines Interchange, she said that patients first of all need to be aware of the risk of receiving counterfeit…[...]
Cooperation between the U.K.’s Medicines and Healthcare Products Regulatory Agency and the USFDA brought the counterfeit Avastin distribution to light in the U.S. when MHRA officials let U.S. Food and Drug Administration agents know in December that they suspected the problem.
MHRA officials notified U.S. agents and Roche, which led Roche to test and confirm the vital life-saving medication as counterfeit last week, reported Reuters.
“As tragic as this incident is, it is to the credit of the manufacturer and law enforcement that they’ve been able to track down the source of the supplier of the counterfeit medication and contact their other customers. In many countries counterfeits make their way to patients without anyone ever being held accountable,” said Partnership for Safe Medicine’s board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute.
Connie Jung, of the FDA’s Office of Drug Security, said it was possible that more than the 19 originally notified practices could be involved and warned that if a price appears to be too good to be true, it probably is.
Sources say that Montana Health Care Solutions sold the vials for 25% less than the expected cost, reports ABC World News.
Patients are beginning to be aware of the counterfeits, with growing outrage.
Said cancer patient Diane Barraza to ABC World News, “To sit in the chemo chair and watch that stuff drop into my veins,” who lives in Fullerton, Calif., with her 6-year-old daughter. “It’s all I’ve got. And it might just be water?”
The FDA has issued letters to 19 US medical practices that purchased medication from a foreign supplier, Quality Specialty Products (QSP), warning that drugs distributed by QSP are known to be unapproved by the FDA, and in at least one instance verified counterfeit.
QSP, also known as Montana Health Care Solutions, has been identified by the FDA as the distributor of counterfeit Avastin. Roche AG, the manufacturer, has said that the counterfeit Avastin was tested and found to contain no active ingredient. Avastin is FDA approved for use in metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer, metastatic kidney cancer, and glioblastoma.[...]