IJCP: Counterfeit Internet Drugs Pose Significant Risks and Discourage Vital Health Checks

A story posted online at redOrbit.com on January 20th explores a recently published review of online internet drugs posted by the International Journal of Clinical Practice (IJCP).

One of the major warnings from the IJCP report is that men who buy fake internet drugs for erection problems can face significant risks from potentially hazardous contents and bypassing healthcare systems could leave associated problems like diabetes and high blood pressure undiagnosed.

The IJCP review, which looks at more than fifty studies published between 1995 and 2009 and provides a valuable overview of the scale of counterfeit internet drugs, with a specific focus on erectile dysfunction (ED) drugs.

Here are some interesting statements from the story:

• Medical and pharmaceutical experts from the UK, Sweden and USA carried out a detailed review of the growing problem of counterfeit drugs. Estimates suggest that up to 90 per cent of these illegal preparations are now sold on the internet.


• These have played a key role in driving the growth of counterfeit drugs, with studies suggesting that as many as 2.3 million ED drugs are sold a month, mostly without prescription, and that 44 per cent of the Viagra offered on the internet is counterfeit.


• The presence of unknown pharmaceutically active ingredients and/or impurities may lead to undesirable and serious adverse events, even death" warns lead author and journal editor Graham Jackson, a London-based cardiologist.


• Pfizer, which manufactures Viagra, analyzed 2,383 suspected counterfeit samples forwarded to the company by law enforcement agencies between 2005 and 2009. It found that that a Hungarian sample contained amphetamine, a UK sample contained caffeine and bulk lactose and that printer ink had been used to color some samples blue. Other samples contained metronidazole, which can have significant adverse effects when combined with alcohol."


• And a study of 370 seized "Viagra" samples carried out by the Dutch National Institute for Public Health found that only 10 were genuine, with a range of other drugs present in the samples.


• "In some cases producing counterfeit medicine can be ten times as profitable per kilogram as heroin, yet in the UK someone can face greater legal sanctions if they produce a counterfeit T-shirt.


• "What is clear is that we need much greater public awareness of the risks of buying counterfeit drugs, as lives are at risk.

To learn more about pharmaceutical anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

To read the entire redOrbit.com story: http://www.redorbit.com/news/health/1811733/counterfeit_internet_drugs_pose_significant_risks_and_discourage_vital_health/index.html

Two Minnesota Men Accused of Distributing Counterfeit Drugs

Two Minnesota men, Nicholas Lundsten, 26, of Spring Lake Park, and Patrick Barron, 29, of Fridley were charged Wednesday for distributing misbranded medication. The pair sent 10,419 pills labeled as Viagra; 3,600 pills labeled as Cialis; 1,582 pills labeled as Propecia; and 340 pills labeled as Levitra.

Viagra is manufactured by Pfizer; Cialis by Eli Lilly; and Levitra by Bayer; all treat erectile dysfunction. Propecia, manufactured by Merck, treats male pattern hair loss.

Lundsten and Barron are also accused of illegally importing about 40,000 pills of alprazolam — used to control anxiety disorders — and about 27,000 pills of sibutramine — an appetite suppressant used to treat obesity — into the United States. Both are classified as "Schedule IV" controlled substances.

The indictments are the result of an investigation by the FDA, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection.

If convicted, Lundsten and Barron face up to six years in prison.

To view entire article, visit: www.startribune.com.

Swiss Say Seizures of Counterfeit Meds Nearly Doubled

This week, Earthtimes reported that Switzerland stated their seizure figures for fake drugs rose 92 percent for the first half of this year. A majority of the counterfeit product came from Asia region, but several regions were also named including eastern and Western Europe.

Swiss say illegal medicines imports nearly double
(July 16, 2009) Geneva - Switzerland reported Thursday a 92 per cent increase in the amount of illegal and counterfeit medicines seized at its border crossings in the first half of this year, compared to the same period last year. The medicine consignments confiscated by Swiss customs officers came from several regions, including eastern and western Europe, the federal authorities said in a statement, though the majority arrived from Asia.

Erectile dysfunction drugs made up 24 per cent of the caught shipments. Slimming products were 14 per cent of the found products followed by muscle enhancers, at 12 per cent.

Slimming products made the largest increase, and health officials warned the public to take care that they only bought official and licensed drugs. The counterfeit products do not always contain the appropriate amounts of active and inactive chemicals and can cause health problems.

The authorities also warned about buying medicines through dubious Websites.

To view the entire article visit the Earth Times website at: www.earthtimes.org.

Hi-Tech Pharmaceuticals Recalls Sexual Performance Supplement

The Food and Drug Administration (FDA) has ordered Hi Tech Pharmaceuticals to recall their sexual performance Supplement Stamina-Rx after it was discovered to contain an undeclared ingredient, benzamidenafil. The ingredient is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Since the recall is due to an undeclared ingredient and Hi-Tech Pharmaceuticals is under a Consent Decree of Permanent Injunction with FDA since September 23, 2003, FDA has ordered a recall of all lots to the consumer level. Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088].

Are Counterfeit Drugs in the U.S. Supply Chain?

The general consensus has always been that only a small amount of counterfeit drugs are in the domestic supply chain. True relatively speaking, the percentage of counterfeits found in the United States is lower (estimated at around 1%) than some underdeveloped countries (estimated as high as 50%).

However, this does not paint the whole picture… The U.S. has almost 43% of the market share, which means there are still thousands of counterfeit pills in our distribution cycle. To the consumer that is a victim, it matters not whether he is in the company of many fellow victims or only a few.

Furthermore, the frequency of counterfeits is increasing in more developed countries such as the U.K and the U.S. Now, incidents are showing up in the regular supply chain as you can see from the following news items:

First Foreign National Extradicted For Importing And Distributing Counterfeit Pharmaceuticals Drugs In U. S. Sentenced To Prison
Randy Gonzales, 40, a citizen of the Republic of the Philippines, was sentenced to prison for his role in a scheme to manufacture, import and distribute counterfeit pharmaceutical drugs in the United States.

Gonzales was extradited to the United States from Bangkok, Thailand on March 26, 2008 and indicted four days later. Special agents of the Immigration and Customs Enforcement (ICE) and the Food and Drug Administration Office of Criminal Investigations (FDA)seized more than 60,000 counterfeit Viagra pills and 15,000 counterfeit Cialis pills. The counterfeit drugs were valued at more than $776,000.


Miami Man Sentenced To 20 Years For Massive Drug Diversion Operation
A Miami man has been sentenced to 20 years in prison for running a massive drug diversion operation that made millions of dollars in illegal profit. Jose Luis Perez, 52, had illegally bought expired, counterfeit or adulterated medicines, relabeled them and shipped them through a series of his own pharmaceutical firms in order to sell them to mainstream suppliers.

Investigators were tipped off by a Cincinnati pharmaceutical wholesaler who, while filling a prescription, noticed that the wrong pills were inside and the accompanying paperwork was for a different drug.

At Perez’ Hialeah warehouse, law enforcement officers found $500,000 of prescription pills used for the treatment of HIV-related illnesses, Schizophrenia and erectile dysfunction. Law enforcement also found counterfeit labels and prescription paperwork for more that $8 million-worth of pharmaceuticals.


Local pharmacist, businesses disciplined by state
(Nov. 30, 2008; The Telegraph) In 2006, Hudson resident Richard Minasian, owner of Nashua-based Armin Medical LLC, pleaded no contest in a Florida court that he and a Miami man had sold drugs with fake pedigrees.

That same year, the New Hampshire Board of Pharmacy revoked Minasian's license to sell drugs for at least 10 years, and he was assessed a $29,000 fine, but $20,000 of it was stayed for two years pending good behavior.


As these stories indicate, government intervention is gearing up and we at XStream Systems applaud the increased authority given to FDA and law officials to seize products and prosecute criminals. But the reality is that these undercover operations often take a year or more to complete. During this time consumers, wholesalers, and repackagers are exposed.

Now is time for businesses to protect themselves and their customers by effectively securing their on-site inventories. It is too late to hide our heads in the sand and deny that counterfeits exist – they do and what are the implications for you if they unknowingly pass through your hands!