Probe Into Fake Cancer Drugs

Cypriot police investigating counterfeit cancer treatment drugs which are being smuggled into the European Union.

In a story by Constantinos Ioannou which appeared in the November 11 issue of the Cyprus Mail, two pharmaceutical companies within Cyprus have been implicated in a case of counterfeit cancer treatment drugs which are being illegally smuggled into the European Union.

According to the Cyprus Mail article:

• Cypriot police received a court order from the German Federal Police on Tuesday and searched four premises on the island, two in Larnaca district and two in Limassol district.

• The premises searched belong to two pharmaceutical companies which have been operational since March. There were also simultaneous searches conducted in Germany, Norway and Switzerland.

• Police spokesman Michael Katsounotos yesterday said: “From investigations conducted so far it does not appear that any crime was committed on Cypriot soil.” Katsounotos also assured the public that none of these counterfeit drugs were available in the Cypriot market.

• According to Katsounotos the counterfeit cancer treatment drugs were manufactured in England and were due to be distributed outside the European Union only. However upon receiving them, pharmacists in an unnamed third country modified the drugs and sold them to various other countries, some of which are based in the European Union. Investigators in Norway and Germany came to the conclusion that the modified counterfeit drugs were brought to Cyprus and then distributed to markets around the world.

• The two pharmaceutical companies on the island which have been implicated in the investigations are alleged to have purchased the counterfeit cancer treatment drugs before distributing them to Norway and Germany.

• Katsounotos said that the owners of the companies have been questioned but it appears at this point that no crime was committed on Cypriot soil. However he added: “Further investigations are due to take place and the completed file will be given to the Attorney-general who will make the final decision if there are any charges to be brought against the companies.” Katsounotos also added that some of the drugs were taken to the Netherlands where documents were falsified to show that they came from Cyprus.

• Katsounotos assured the public that none of the drugs were available in Cyprus, although he could not clarify if the counterfeit cancer treatment drugs were in Cyprus at any point.

• “That is the object of our investigation, what we know as fact is that documents were falsified in Holland to show that these drugs came from Cyprus,” he said.

• The Director of the State Laboratory Popi Kanari also warned yesterday that the use of counterfeit drugs, which can be usually purchased via the internet or other unofficial sources may pose serious risks to a person’s health.

• Kanari stressed that these drugs have not gone through the proper procedure of registration at the ministry of health. Kanari said: “Such drugs have been tested numerous times by the lab and have been found to contain toxic substances that can cause serious problems to one’s health”.

The criminal act of counterfeit medications is not limited to undeveloped countries and traditional black market activities.

Adulterated, fraudulent, sub-standard and counterfeit medications are making their way into the legitimate supply chains in developed countries by using illegal transactions and documentation.

The fraud of altering the transactional drug pedigrees, basically authenticating counterfeit or sub-standard drugs as real and efficacious is as dangerous and lethal to the patient as the poisons inside the bogus drugs.

The danger counterfeit drugs represent to entire health care populations is very real and all members of the pharmaceutical supply chain should take proactive measures to protect their inventories and consumers.

Authenticating and verifying what is inside the medications is the only way to make certain that the consumer is taking the real thing.

To read the entire Cyprus Mail article, visit: http://www.cyprus-mail.com/healthcare/probe-fake-cancer-drugs/20101111

To learn more about proactive, anti-counterfeiting authentication technologies, visit: http://www.xstreamsystems.net/

IPS: Fake Medicines May Kill a Million a Year

Central and Eastern Europe is facing "significant challenges" in combating a multi-billion euro, and often lethal, trade in fake medicines, security and pharmaceutical groups have warned.

Pavol Strancansky writes a disturbing if not interesting story about the size, scope and danger of counterfeit medication in Europe for the Inter Press Service. The story is full of insider insight and current statistics.

Included in Mr. Strancansky’s story:

• Millions of counterfeit tablets and medicines, some of them containing lethal heavy metals, are smuggled annually. The World Health Organisation (WHO) estimates that 50 percent of medicines sold online are fake.

• But while some Eastern European states have brought in strict laws and procedures to fight fake medicine smugglers, criminals in the region are thought to be working with international gangs in neighbouring states to bring contraband medicines into the EU.

• Gabriel Turcu, partner at the European anti-counterfeiting organisation REACT, told IPS: "It has been shown that there are people in Central and Eastern European EU member states working with organised gangs in neighbouring countries to bring counterfeit medicines into the European Union and westwards. This is a significant challenge for the region."

• Just like the drug and people trafficking trade, the counterfeit medicine industry is estimated to be worth tens of billions of euros per year for crime gangs, and is mushrooming every year.

• The United Nations Office on Drugs and Crime has estimated that this year the illegal market in counterfeit medicines will provide more than 75 billion euros in revenues for smugglers -- a rise of 92 percent on 2005.

• Police forces say that fake medicines, sometimes so well-prepared and packaged that they can fool even healthcare professionals, are being shipped out by crooks in the same illegal consignments as narcotics. Gangs then sell them on to unscrupulous medicine wholesalers or direct to the public online.

• Health experts estimate that fake medicines -- made from anything from crushed brick to arsenic -- cause up to one million deaths a year, and the UN has said they are contributing to growing drug resistance.

• India and China are thought to be the main source countries for the fake medicines, but customs officers in central and Eastern Europe have said that they are being brought into Europe on the same smuggling routes used for narcotics and people -- through Eastern Europe and the Balkans.

• Pfizer issued a report earlier this year saying that the market in counterfeit medicines in Europe is worth an estimated 10.5 billion euros annually, with people in Italy and Germany spending the most on what later turn out to be fake medicines -- an estimated 3.6 billion and 2.7 billion euros respectively.

• EU officials have said that in a two-month period last year 34 million fake tablets were seized by customs officials while the Council of Europe says that in some parts of Europe fake medicines make up between six and 20 percent of the market.

• Public awareness of the risks of counterfeit medicines is also low, according to research.

• While punishments for drug running and people smuggling are severe and risks high, those for counterfeit medicines are generally far less. In some countries production and selling of counterfeit medicines is not considered a crime and in many Western states it was until relatively recently viewed legally as being on a par with trading in fake branded clothes.

• Turcu, who last week attended a special conference in Bucharest which brought together country representatives and law enforcement officials from across the region to discuss the threat of counterfeit medicines, told IPS: "What is needed is a directive from the EU making it mandatory for countries at national level to qualify counterfeiting as a crime and counterfeiting that harms people as a serious crime."

Along with regulatory action, public awareness and action by industry leaders and members of the pharmaceutical supply chain are crucial in eradicating this very serious, potentially lethal crime.

To read the entire IPS story, visit: http://ipsnews.net/news.asp?idnews=53318

To learn more about anti-counterfeiting technologies designed for pharmaceuticals, visit: http://www.xstreamsystems.net/.

Healthcare Fraud Costing EU €56bn a Year

In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

Euractiv.com posted a story about a study stating that €56 billion is lost to healthcare fraud each year in the EU.

In the October 6th post, Euractiv.com claims that experts say conflicts of interest in the pharmaceutical sector mean that the true extent of expenditure being directed away from patients remains unknown.

The study by The European Healthcare Fraud and Corruption Network (EHFCN) was done to determine “the burden healthcare fraud places on society and facilitate the exchange of best practice on its detection.”

The research was conducted in the countries of Belgium, France, the Netherlands, Northern Ireland, Norway, Poland, Slovenia and Scotland and was presented at the EHFCN conference in Brussels in September.

According to the EHFCN report:

• The vast number of parties involved in the healthcare sector and the subsequent potential complexity of fraud schemes means that special fraud detectors - professionals already working in health care - have to be employed in order to carry out investigations into bills, patient notes and medication receipts.

• Trade in counterfeit medicines has exploded and it is now estimated that global counterfeit drug sales will reach €60 billion this year. In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

• Low quality treatment - including from unqualified practitioners, forged receipts and sickness certificates, price cartels and the provision of counterfeit medicines - were identified as contributing to a phenomenon difficult to measure but ringing alarm bells at a time when austerity measures are being undertaken across the EU.

• 4,188 instances of suspected fraud were identified in the study, which was carried out in seven member states. The Netherlands and Belgium - working under a 'pay for service' system where doctors have an incentive to provide as much treatment as possible - hold the highest rates.

Hopefully this study will bring awareness to government, industry leaders and consumers to the negative impact that fraudulent, adulterated, sub-standard and counterfeit drugs have on health care and populations as a whole.

Secure Pharma Chain believes that it is important that all members of the pharmaceutical supply chain take proactive measures to deploy solutions to protect their inventories and provide themselves with a competitive edge as consumers begin to understand the potential risks of counterfeit and fraudulent medications.

To read the entire Euractiv.com story, visit: http://www.euractiv.com/en/health/healthcare-fraud-costing-eu-56bn-a-year-news-498480

To learn about pharmaceutical anti-counterfeiting technologies, visit: www.xstreamsystems.net.

SecuringPharma: Medicine Seizures by EU Customs Rise Again in 2009

Phil Taylor in a July 23rd post in SecuringPharma.com writes about the increase in the seizure of pharmaceuticals from 2008 to 2009.

Although overall there were fewer detained shipments from 2008 to 2009 apparently “the downturn did not extend to medicinal products”.

Also in the blog, Mr. Taylor adds some curious statistics as to what countries lead the way in originating and presumably supplying many of the interdicted medications.

It would appear that the criminal elements behind counterfeiting must be realizing the high profit and low risk associated with pharmaceutical counterfeiting which means a far higher risk to consumers everywhere.

Secure Pharma Chain encourages all regulatory and pharmaceutical supply chain members utilize solutions and technologies such as XStream Systems’ XT250 to authenticate and secure supply chain transactions and inventories to protect the end use consumers.

Here are some of the highlights and interesting statistics from Mr. Taylor’s post:

· Customs officers in the European Union detained fewer shipments suspected of infringing intellectual property rights in 2009 compared to 2008, but sadly that downturn did not extend to medicinal products.

· Overall medicines accounted for around 10 per cent of all the 118 million articles intercepted by EU customs last year, and 8 per cent of the 43,500 individual cases.

· In absolute terms, the number of seized medical products rose to around 11.5 million from a little under 9 million in 2008, which in turn was double the number in 2007.

· The origins of the intercepted medicine shipments also makes interesting reading with 74 per cent of the articles coming from United Arab Emirates - a well-known hub for goods in transit from other markets into the EU - and 23 per cent coming from India.

· China featured highly among other industrial sectors such as apparel and electronics, but was the source in just 1.4 per cent of medicinal product detentions. The only other country of origin worth mentioning was Syria, with around 1 per cent of the total.

To read SecuringPharma’s post, visit: http://www.securingpharma.com/40/articles/532.php.

To learn more about supply chain security technologies, visit: http://www.xstreamsystems.net/.

Securing Pharma: Survey Reveals European Views on Counterfeits

A study posted online on SecuringPharma.com on November 25th, was conducted by ICM and sponsored by Aegate.

The results demonstrate the awareness of counterfeit products in general and drugs in particular on the European continent. The research was based on interviews with 5,000 consumers in five European countries between October 15 -21, 2009.

The findings show a growing awareness of counterfeit drugs which seemingly correlates with the growth of issue within developed countries globally. The following are several interesting findings from the study:

· One in 20 Europeans suspect they have received a counterfeit prescription drug and 1 per cent believe they definitely have, according to consumer research group ICM. Which translates to as many as 12.8 million European consumers could have been exposed to counterfeit drugs.
· Awareness of the phony drugs market was moderate, with 61 per cent of those polled saying they know prescription drugs can be faked. Awareness was higher in the UK, at 75 per cent.
· Medicines topped the list of counterfeit items that respondents said would most concern them - at 79 per cent - with all other items mentioned in the poll (clothes, toys, cosmetics, alcohol, CDs and DVDs, cigarettes and golf clubs) in the low single digits.
· Consumers see the fake drugs trade to be largely the responsibility of medicines suppliers, with 45 per cent saying the manufacturer is responsible for keeping counterfeits out of the supply chain, 31 per cent saying it is the responsibility of the wholesaler and 30 per cent pointing to the pharmacist.
· Consumers also want tougher punishments. Over two thirds of them believe the penalty for counterfeiting medicines should be between five and 15 years in prison, despite the current penalties being far lower - while 19 per cent felt a life sentence was warranted by the crime.
· Meanwhile, 85 per cent of consumers said they would feel more confident if medicine packs contained a safety feature that enabled the pharmacist to verify the medicine is genuine before dispensing.
· In addition, 90 per cent said they would not buy drugs on-line if pharmacies in Europe had a tool to authenticate prescription drugs.

To read the entire article online in SecuringPharma, visit their website at: www.securingpharma.com.

To learn more about XStream Systems robust solution to counterfeit products, visit our website at: www.xstreamsystems.net.

Up to 30 per cent of EU generics 'contain falsified APIs'

On Friday, SecuringPharma, published an interesting article on the quality of active pharmaceutical ingredients (APIs) in European generics.

The European Fine Chemicals Group claims that 20 to 30 percent of the APIs come from unapproved sources.

EFCG board member Guy Villax quoted that figure, which he attributed to EU inspectors, at a press conference at the Conference on Pharmaceutical Ingredients (CPhI) held last week in Madrid, Spain.

This causes a huge challenge to the validity and efficiency of the finished product as a single batch of an API can reach from 10,000 to 1,000,000 patients. Currently a manufacturer receives Good Manufacturing Practice (GMP) certification based not only on their own practices, but those of their suppliers as well. If their suppliers are in reality not as they have stated, you can see how this circumvents the inspection process.

Council of Europe is drafting legislation on counterfeit medicines to be reviewed by 40 countries. However, EFCG does not agree with the current wording of the EU's draft directive which suggests that API manufacturers can be inspected by their own domestic authorities, providing their enforcement systems are deemed 'equivalent' by the EU, i.e. they conform to ICH Q7 and are based on regular inspections.

This would work with countries such as the USA, Japan and Australia, said Villax, but he is concerned that equivalence could be granted for political reasons to other countries where the systems may be prone to fraud and corruption.

We at XStream Systems agree that the quality of the finished product is only as good as the quality of the ingredients that are contained therein. In the United States this was only too evident in last year’s case of tainted heparin, where the active ingredient had been tainted by unapproved suppliers and resulted in the death of over 80 people.

To view the entire article visit: www.securingpharma.com.

Euractive.com: Commission Slammed Over Internet Medicines

According to Euractive.com:

The Minister responsible for steering the Counterfeit Medicines Directive through the European Parliament has lashed out at the EU executive for failing to include online sales in the scope of the proposal.

Adamos Adamou (GUE/NGL, Cyprus) described the Internet as a "Trojan horse" in the medicines supply chain that the Commission has left the Parliament to deal with.

He said there were a number of flaws in the proposed directive, including the failure to provide a definition of counterfeit medicines and the omission of excipients such as the capsules used to package active ingredients.

Adamou said he had drafted amendments which would extend the scope of the directive to include over-the-counter medicines and to harmonize safety features on medicine packaging.

"Today, there is no guarantee of buying safe medicines. Counterfeit medicines are a form of terrorism against human health. It doesn't matter whether a pill contains sugar or poison. If the safety is compromised, so is our health," he said.

To View entire piece, visit: www.euractiv.com.

Dramatic Rise in Drug Seizures by EU Customs

SecuringPharma.com posted a story by Phil Taylor on July 24th, outlining and giving background on an astounding increase in drug seizures by EU Customs Officials.

Some interesting tidbits include:

• Seizures of pharmaceutical products at the European Union’s borders rose 57 per cent last year, while the total number of items detained more than doubled to around 8m items.


• That increase came against a backdrop of a 13 per cent hike across all product categories to nearly 50,000 seizures overall, with the number of detained articles swelling to 180m from 80m in 2007.The report notes that seizures of medicines were among the most controversial developments in 2008.


• There were cases in which generic medicines destined for a developing nation being seized in transit at EU borders, even though they did not infringe intellectual property rights in their destination markets (such as Latin America and Africa).


• Around 70 per cent of all seizures were carried out at the request of an intellectual property rights holder, with the remainder ex officio actions by customs officials where there was a suspicion of infringement.

To read the story visit SecuringPharma.com at the following link: http://www.securingpharma.com/40/articles/184.php

FDA says drug stores sold expired medications

The Medicine Shoppe, a subsidiary of Cardinal Health (one of the “Big Three Distributors”), sold expired or presumed fake prescriptions to their customers. Granted this was just two of their stores located in Baltimore, but it does make one wonder – How did this happen?

Especially troubling is that this may just be the beginning. In Europe, officials are seeing an upward trend of expired product simply being relabeled to appear good. It is estimated that 10% of medicines sold there are counterfeited or adulterated.

The Medicine Shoppe's suspect medications and the conditions they treat include:

• Lisinopril (20 milligrams) _ hypertension
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg) _ cough
• Gabapentin (100 mg, 300 mg and 400 mg) _ epilepsy
• Metoprolol (50 mg) _ hypertension
• Nifedipine (30 mg) _ hypertension
• Diclofenac Sodium (30 mg) _ anti-inflammatory
• Glucophage (500 mg Extended Release) _ diabetes
• Glucovance (125 mg and 500 mg) _ diabetes
• Glipizide/Metformin (2.50 mg/250 mg) _ diabetes
• Furosemide (20 mg) _ diuretic
• Tamoxifen Citrate (10 mg) _ breast cancer
• Metformin HCl ER (500 mg) _ diabetes
• Calcitrol (0.25 micrograms) _ osteoporosis

It has long been assumed that if product was purchased straight from the manufacturer and/or one of the major distributors, that naturally, the medicine was pristine. However, these days that assumption, sadly, is no longer valid. This year alone, we have witnessed recalls from Baxter for adulterated heparin, Ranbaxy for counterfeit HIV medications, and NOW a major drug store chain for fake or expired prescriptions.

To view the full article from Associated Press, click here.


Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

"Drug counterfeiting underestimated for too long..." states the Chairman of Sanofi-Aventis

As reported by the Dow Jones News Service, "Drug counterfeiting has been underestimated for too long, Sanofi-Aventis Chairman said Thursday, also calling for more action from the European Union."

At the annual meeting of the European Federation of Pharmaceutical Industries and Associations, Jean-Francois Dehecq said that "drug counterfeiting 'used to be marginal, it is now totally industrialized.'" Counterfeit pharmaceuticals "represented approximately EUR45 billion in sales in 2006, making up for almost 10 percent of the world pharmaceutical market the World Health Organization estimates.

Link to the full story at Dow Jones.