42 Police Raids In Argentinean Counterfeit Drug Probe

In Argentina, 42 raids were conducted as part of continuing investigations into counterfeit and illegal drug distribution by organized crime.

According to the Argentinean news organization, Momento 24, Argentinean authorities are continuing their two year investigation of counterfeit drug sellers that operate within workers' unions that involve the use of expired drugs, counterfeiting and murder.

Last week Judge Norberto Oyarbide ordered over 40 raids on suspected workers’ union sites in Capital Federal, Avellaneda, San Justo and other interior locations within Argentina.

As reported by Partnership for Safe Medicines: Among the organizations raided were employment organizations for truckers, metalworkers, air navigators, lottery, port, petrochemical, turf, post and telecommunications, teachers and automotive industries.

In Argentina, healthcare including doctor care and prescription drugs are distributed to the majority of Argentineans’ through their employment union organizations.

According to Momento 24:

• Police collected documentation on the purchase and distribution of cancer drugs, hemophilia medication and AIDS drugs.

• Police are looking for possible connections with drug companies, including San Javier of businessman Nestor Lorenzo, previously arrested and prosecuted for organized crime medicine distribution in 2009.

In earlier reports by Momento 24, Mr. Lorenzo has testified in the investigation for the murders of Sebastián Forza, Damian Ferron and Leopoldo Bina. He testified on the chain of suppliers and creditors of Forza, who, allegedly, sold a shipment of counterfeit hemophilia medications to the National Drug and Technology Agency (Anmat).

According to an earlier Momento 24 story, one of Mr. Lorenzo’s previous business partners in a small chain of drug stores, Luis Marcelo Tarzia died in jail after his arrest for allegedly being the local manager of a Mexican drug gang that set up a methamphetamine lab in Ingeniero Maschwitz.

This is a cautionary tale to industry stakeholders and consumers of pharmaceuticals within developed countries over the possible interdiction of dangerous medications within the legitimate supply chain.

Unfortunately this type of crime is becoming commonplace within the legitimate supply chain in the UK, Germany and even the United States.

Because of its high profit and low risk, counterfeiting or dealing in adulterated, fraudulent or sub-standard medications has become a lucrative trade and has drawn the attention of organized criminal elements. The real danger however is that it not only impacts those involved with the transaction but has potentially lethal implications for unsuspecting consumers who take these dangerous knock offs.

All members of the pharmaceutical supply chain must proactively take measures to protect their inventories.

To read the entire Momento 24 story, visit: http://momento24.com/en/2010/11/26/at-least-42-police-raids-on-the-case-of-counterfeit-drugs/

To read the entire story on Partnership for Safe Medicine, visit: http://www.safemedicines.org/2010/12/argentina-federales-investigate-fake-drug-crime-ring-60.html

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

Chinese Court Jails Four for Fake Medicine

Chinese gang sentenced to jail for selling expired and bogus medications.

According to a story in the Shanghai Daily, four members of a group that sold expired medicine and produced fake prescription drugs without a license were given jail sentences ranging from eleven months to five and a half years yesterday.

According to the Shanghai Daily story:

• The drugs produced by the gang were tested and found to be fake. Fortunately, none of them were sold thanks to quick action by the police.

• The Putuo District People's Court heard that the gang collected expired medicine around the city at low prices and then sold them outside Shanghai, after changing the production and expiration dates on the labels.

• Zhang Dezhi, 45, from Liaoning Province, and Zhang Wenzhong, 48, from Anhui Province, who do not have licenses to sell or produce drugs, began to collect medicines around the city last year, the court heard.

• Police seized more than 3,100 boxes of medicine in Zhang Dezhi's home in Shanghai on February 3 and intercepted more than 20,000 boxes on their way to Shen-yang. They were estimated to be worth around 550,000 yuan (US$82,614).

• Police later confiscated medicine valued at 230,000 yuan from Wang's home in Shenyang, and drugs in Zhang Wenzhong's residence in Shanghai valued at more than 400,000 yuan.

• In addition to collecting and selling the drugs, Zhang Dezhi also produced fake drugs by buying in cheap and inferior medicines and attaching false labels of more expensive brands.

Hopefully this is a sign that as reported previously in Secure Pharma Chain, Chinese officials are becoming proactive and more diligent in aggressively prosecuting a lethal crime that impacts the lives of their population and that they export around the world.

China and India have become the epicenter of a global counterfeit drug issue that is worth billions annually and is estimated to kill and impact the health of millions.

To read the entire Shanghai Daily story, visit: http://english.eastday.com/e/101126/u1a5572554.html

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

China Launches New Product Piracy Crackdown

According to Bloomberg News and the Associated Press, China's government is launching a new six-month crackdown on rampant copying and counterfeiting of software, medicines and other goods.

According to the reported announcement:

• The announcement comes amid complaints by industry groups that piracy of software and some other goods is growing despite repeated government pledges to stamp it out.

• Cabinet officials said the crackdown will target a wide array of products from illegally copied computer software to corn that is falsely labeled as organic.

• Fake or illegally copied music, designer clothes, medicines and other goods are widely available in China. Industry groups say Chinese piracy costs legitimate producers billions of dollars a year in lost sales.

China leads the way in fraudulent, adulterated, sub-standard and counterfeit medications that is exported to the developed and underdeveloped nation’s pharmaceutical supply chains.

Hopefully this announcement is a serious effort on behalf of the Chinese government to protect consumers around the globe from this potentially lethal crime.

To read the entire Bloomberg News story, visit: http://www.bloomberg.com/news/2010-11-30/china-launches-new-product-piracy-crackdown.html

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

The Lancet: Tackling the Booming Trade in Counterfeit Drugs

The black market in counterfeit drugs is worth billions, but it does untold damage to the health of the poorest populations.

Nayanah Siva writes an exceptional article in the November 20th issue of The Lancet on international efforts to tackle the problem of counterfeit drugs.

The importance of this article is the excellent timely information and its historical perspective.

Highlights of The Lancet editorial article include:

• WHO are of the opinion that “studies can only give snapshots of the immediate situation. Counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day, so when the results of a study are released, they may already be outdated.

• “In many cases where successful actions against counterfeit, illegal and substandard drugs were undertaken by authorities, little public information is forthcoming about the case…As a consequence it is difficult for the stakeholders to understand the nature and extent of the problem, let alone to develop strategies to combat illegal medicines.”

• Steve Allen, Senior Director of Pfizer Global Security told The Lancet “I saw [counterfeiting] first hand in Tanzania last year, where we had anti-malarial products being counterfeited, to the degree that they were using identical batch numbers, identical expiry dates, the packaging, to all intents and purposes, seemed to be absolutely genuine, the blisters looked genuine, the tablets looked as if they were genuine, you would not be able to tell the difference, I can promise you, I've seen them myself.” It was only after these tablets were tested in a laboratory in the UK that it was discovered they had no active ingredients at all. “I can't think of many more worst-case scenarios, you have a counterfeiter somewhere in the world manufacturing a medicine for someone [pregnant women], she believes she might die anyway from malaria but it also impacts the unborn child, it is one of the most despicable of crimes.”

• The problem, Allen explains, is that counterfeiting is a “relatively low-risk, high-reward business to be in…and that is why organized crime gangs are using this far more frequently. In 2006 our colleagues in the narcotics units in Istanbul raided a manufacturing plant for narcotics but actually discovered a large quantity of our erectile dysfunction products and at the same time recovered 378,000 ecstasy tablets alongside the ingredients to manufacture 150 kg of heroin.”

• Newton is deeply concerned about the substantial detrimental effects counterfeit medicines have on African populations. “The main consequences…are increased mortality and morbidity, endangering drug resistance and loss of medicine efficacy, loss of confidence in health systems and health workers, economic loss for patients, their families, health systems, and the producers and traders in good-quality medicines, adverse effects from incorrect active ingredients, a waste of enormous human efforts and financial outlay in the development and manufacture of medicines…”

• Allen emphasizes the importance of international collaboration among regulators, the pharmaceutical industry and political representatives, and thinks this strategy will have the best chances of tackling counterfeiting. “This is not just an issue for one company, it is not an issue for one country, it is an issue for all of us.”

• Counterfeit drug crime is a complex issue requiring international and regional initiatives among industry, government, charities, and law enforcement…More political will and collaboration between medicine regulatory authorities, police and customs is essential.

All members of the legitimate pharmaceutical supply chain (governments, manufacturers, distributors and dispensers) must take it upon themselves to proactively protect and interdict their inventories from adulterated, fraudulent, sub-standard and counterfeit medications. This is a critical step by all of the supply chain stakeholders as a way to protect their industry, individual businesses and most importantly the consumer.

Everyone must be made aware that the impact of counterfeit drugs knows no borders. What happens in underdeveloped nations will ultimately impact and effect populations in developed nations around the globe.

To read the entire The Lancet editorial article which appeared in Volume 376, visit: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962118-6/fulltext

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

Counterfeit Medicines: Health and Harm

Counterfeiting has a long history. For most commodities it is simply the theft of brand owners' intellectual property, a trademark violation. But fake medicines can also kill.

Political wrangling over language, and confusion over how to deal with the public health and private property aspects of counterfeiting, is hampering international action.

Charles Clift writes an excellent article for the December 2010 issue of The World Today that goes into detail and insightfully probes into the issues, aspects and consequences surrounding drug counterfeiting.

Mr. Clift’s article is a must read for both those who are schooled on the issue and the uninitiated.

Here are a few insights from Mr. Clift’s The World Today article:

• Counterfeit, falsified and substandard medicines pose a considerable threat to health. Although detailed knowledge of their prevalence and impact on human well-being is limited, they can fail to cure, promote antimicrobial resistance, and ultimately kill. The threat from these medicines is probably growing, particularly in poorer countries with weak regulation and poorly monitored distribution networks.

• Counterfeiting can be very profitable, and those who do it are becoming increasingly sophisticated, which makes patients in developing countries, who usually have to buy medicines from their own resources, particularly vulnerable.

• In the case of food, medicines, cosmetics and some other goods, counterfeiting can also pose a serious threat to human health because products are likely to be either substandard or contain positively dangerous components or ingredients. This kind of counterfeiting is thus qualitatively different from, for example, a fake Rolex watch.

• Pharmaceutical products are a rather special case for several reasons. Typically it is more difficult to decide whether a product is counterfeit or not, not least because the consumer or prescriber cannot know the contents of the medicine. Before they can be legally marketed, medical products are, at least in principle, subject to much stronger regulation concerning their safety and quality than other items. Bodies such as the Food and Drug Administration in the US are responsible, so counterfeit products will also contravene drug safety, as well as intellectual property, laws.

• The general war on counterfeits is principally about protecting markets and private intellectual property rights, but in the case of pharmaceuticals this self-interested motive is overlaid by a concern to protect public health. The combination of self-interested and altruistic motives can be confusing to observers, and suspicious to some.

• However, the issue of counterfeit medicines has recently become extremely controversial. The definition that the World Health Organization (WHO) first developed in 1992 has generated continuing controversy by conflating the concept of counterfeiting - which has a specific meaning in relation to intellectual property - with issues concerned with the quality, safety and efficacy of medicines.

• Thus, counterfeits become inextricably confused with medicines that are falsified in some other way - for example by concealing their true identity and source - and medicines that are simply substandard: not containing ingredients to the specifications required by regulatory authorities.

• In addition, concerns have been raised that anti-counterfeiting measures might lead to threats to the legitimate trade in generic drugs. These concerns were made worse by the detention in the European Union (EU) in 2008 of generic versions of brand name drugs in transit from India to other developing country markets on the grounds they were infringing European patents.

• Undoubtedly, no one supports the work of the counterfeiters, with the harm they can do to sick people. The controversies are a reflection, in part, of perceived conflicts of economic interest between countries with brand name and generic pharmaceutical industries in the means used to tackle counterfeiting, as well as substandard medicines in general.

• Overcoming these perceptions of conflicting interest, including ensuring that definitions and rules and procedures do not discriminate between generic and brand name products, will be the key to more effective anti-counterfeiting measures.

Mr. Clift’s article is an excellent encapsulation of the problem of counterfeit medications and the complexity in dealing with this deadly crime.

To read and download the entire The World Today article, visit: http://www.chathamhouse.org.uk/publications/twt/archive/view/-/id/2102/


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

SafeMeds: Mississippi Stores Selling Counterfeit Drugs Raided

Operation Knock Out Knock Offs- A law enforcement partnership in Mississippi between federal, state and local officials, yields approximately 30 federal search warrants in search of counterfeit pharmaceuticals.

According to a press release from the Mississippi’s Attorney General’s Office and a blog post in SafeMeds:

• On November 18, a team of nearly 100 law enforcement agents from the U.S. Attorney’s Office-Northern and Southern Districts (MS), the Department of Homeland Security/Immigration and Customs Enforcement (ICE), the Food and Drug Administration and the Mississippi Attorney General’s Office, participated in raids via Mississippi’s Operation Knock Out Knock-Offs Task Force.

• "[The raids are] a key example of how Operation Knock Out Knock-Offs is working in Mississippi," said Attorney General Jim Hood. "By partnering with federal and local officials, we can help protect consumers from dangerous fakes."

• The first part of the operation focused on creating the state task force and the second phase centered around educating consumers and vendors about the dangers of counterfeit drugs. The operation received additional federal funding in October and will continue into next year.

• "We are just getting started," said Hood. "Counterfeiters are on notice that we mean business."

• From February 2010 to November 2010 undercover agents made dozens of purchases of counterfeit drugs at “convenience type businesses” throughout the Magnolia State. These counterfeit drugs reportedly included fake pain killers, antibiotics and birth control medication along with supplements not approved for sale in America.

• "Unapproved, uncleared, or misbranded products pose a clear and present danger to the public health," said David W. Bourne, Special Agent in Charge of U.S. Food and Drug Administration's Office of Criminal Investigations Miami Field Office. "We will continue to join with our law enforcement counterparts to aggressively pursue those who place consumers at risk for their own financial gain."

• "The smuggling of substandard, tainted or counterfeit products violates U.S. laws and regulations and threatens public health and safety," said, Raymond R. Parmer, Jr., special agent in charge of the ICE Homeland Security Investigations (HSI) office in New Orleans. "Our ability to work together across the federal government and with agencies around the world is a strong and appropriate response to a growing international threat."

The deadly criminal phenomenon of counterfeit medications is not limited to underdeveloped countries. These products exist, have significant consequence to the consumer and have the ability to become part of the legitimate supply chain.

All members of the legitimate supply chain must proactively protect their inventories and customers from these lethal fakes.

To read the entire SafeMeds post, visit: http://www.safemedicines.org/2010/11/mississippi-stores-selling-counterfeit-drugs-raided-51.html

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

Pharmalot: Another Day, Another Johnson & Johnson Recall

Ed Silverman continues his insightful and humorous blogging on yet another recall from J&J’s McNeil Consumer Health unit:

Highlighted in Mr. Silverman's blog:

• Once again, Johnson & Johnson has yanked a huge amount of over-the-counter medicines. This time, the recall involved about 4 million packages of children’s Benadryl allergy tablets and about 800,000 bottles of children’s Motrin caplets from pharmacies and distributors due to “inefficiencies” in manufacturing.

• Specifically, all product lots of Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors distributed in the US, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength Motrin Caplets distributed in the US. However, there was no indication of any adverse event reports or that the products “do not meet quality standards,” she wrote. Consequently, consumers can continue to use the products.

• Unlike the series of previous recalls, the health care giant did not issue a press release to announce these moves. When asked to explain the difference in procedure, the spokeswoman wrote this is considered a distributor recall, but that the info was posted on the individual product web sites on Nov. 15.

• Tens of millions of bottles have since been recalled; a plant in Fort Washington, Pa., has been shuttered and may be retrofitted; some 300 plant workers lost their jobs; Congressional hearings have been held; federal and state investigations are under way; consumer confidence in the company is falling; a quality control guru was appointed at the corporate level and at least $600 million in sales will be lost this year.

Since the posting of the Pharmalot blog, J&J has added another recall, this time of nearly 9 million bottles of Tylenol.

At some point, it seems logical that J&J would aggressively be doing everything in its power to alleviate these quality control issues.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/11/another-day-another-johnson-johnson-recall/