Canadian Man Pleads Guilty to Selling Counterfeit Cancer Drugs

Tuesday, Hazim Gaber, 22 of Edmonton, Canada, pleaded guilty to selling counterfeit cancer drugs over the internet. Gaber admitted selling what he falsely claimed was the experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the United States, Canada, the United Kingdom, Belgium and the Netherlands between October and November 2007. According to the plea agreement, Gaber charged $23.68 for 10 grams of the purported DCA, $45.52 for 20 grams or $110.27 for 100 grams, plus shipping.

DCA is an experimental cancer drug not yet approved for use in the United States or Canada. DCA is an odorless, colorless, inexpensive, relatively non-toxic experimental cancer drug that is highly sought after by cancer patients. A doctor at the University of Alberta in Canada published a report in early 2007 summarizing the results of a study, which showed that DCA caused regression in several cancers, including lung cancer, breast cancer, and cancerous brain tumors.

Gaber sold the counterfeits through a website named DCAdvice.com, which falsely claimed that it was the only authorized representative to sell DCA and was affiliated with the University of Alberta. Further lab analysis determined that the substances sold contained starch, dextrin, dextrose or lactose, and contained no DCA.

Gaber faces a maximum prison sentence of 20 years on each of the five counts of wire fraud to which he pleaded guilty. Gaber also faces maximum fines of $250,000 per count. As part of the plea agreement, Gaber agreed to forfeit or cancel any website, domain name or Internet services account related to this fraud scheme.


XStream System applauds all the regulatory and enforcement agencies involved in the capture of this counterfeiter: Criminal Division’s Computer Crime, Intellectual Property Section, Assistant U.S. Attorney Peter Sexton of the U.S. Attorney’s Office for the District of Arizona. the Edmonton Police Service, the Alberta Justice Office of Special Prosecutions-Edmonton, the Competition Bureau of Canada, the U.S. Postal Inspection Service, the Federal Trade Commission and the Alberta Partnership Against Cross Border Fraud, The Criminal Division’s Office of International Affairs and the Phoenix FBI Cyber Squad.

To view the Dept of Justice Press Release visit: www.justice.gov.

To view information regarding counterfeit detection solutions visit: www.xstreamsystems.net.

Canadian Drug Maker Apotex Recalls Medications

CanWest News Service Reported September 17th that Canadian generic drug giant Apotex voluntarily recalled some of its drugs late Thursday following a Health Canada investigation launched last July into the company's manufacturing practices.

The investigation was initiated after U.S. regulators found "significant deviations" from good manufacturing practices during an inspection at Apotex's Toronto plant.

In a news release, Health Canada said Thursday the recall applies to three lots of drugs including:

• Apo-Amilzide (5 to 50 mg),
• Apo-Meloxicam (7.5 and 15 mg)
• Apo-Ranitidine (75 and 150 mg)

These medications are used to treat rheumatoid arthritis, osteoarthritis, excess stomach acid or liver cirrhosis.

Health Canada said that it will continue to inspect the Apotex facilities for the next few weeks to ensure that there is compliance.

It urges any Canadians currently taking the drugs to contact their family doctor.
The FDA warned Apotex in June that officials would begin blocking drugs at the border by the Toronto-based company if it did not begin complying with good manufacturing practices, which are universally accepted standards for product quality control.

To read the entire CanWest article visit: www.canada.com.

US Drug makers Express Concern with USA Trading Partner Countries

The US Trade Representative (USTR) released its 2009 Special 301 Report on Friday May 1, 2009. According to the report, US drug makers have expressed concern over the policies of a number of USA’s trading partners - including Canada, France, Germany, Italy, Japan, New Zealand and Taiwan in regards to global intellectual property protection.

“In this time of economic uncertainty, we need to redouble our efforts to work with all of our trading partners – even our closest allies and neighbors such as Canada – to enhance protection and enforcement of intellectual property rights in the context of a rules-based trading system,” said the USTR, Ambassador Ron Kirk.

The USTR Priority Watch List for 2009 names countries requiring particular scrutiny - Algeria, Argentina, Canada, Chile, France, Germany, India, Indonesia, Israel, Italy, Japan, New Zealand, Pakistan, Taiwan, Thailand and Venezuela. Canada was added to list for the first time this year, due to “increasing concern about the continuing need for copyright reform, as well as continuing concern about weak border enforcement.”

Brazil, China, India, Indonesia and Russia are listed as areas where the manufacture of counterfeit drugs is rampant.

Indonesia joins the list for its counterfeit manufacturing, its counterfeit drug trade and the introduction last year’s law on the operation of foreign pharmaceutical companies that raises “significant market access concerns;”

China is also listed due to its regulatory lapse in the enforcement of active pharmaceutical ingredients (API) – since often these ingredients are not declared as a bulk chemical intended for use in pharmaceuticals by API makers to avoid regulatory oversight.

To read a recap on the USTR Report visit Pharma Times.

It is understandable that China’s lack of regulatory control for APIs would be of particular concern to the US since China provides 40% of the APIs for drugs. The impact of this danger was felt dramatically last year when an adulterated substance added by a Chinese supplier resulted in the heparin recall and almost 100 deaths in the United States.