WHO Fears Growing Malaria Drug Resistance May Be Spreading

WHO officials say counterfeit drugs and poor storage are to blame.

Ron Corben in the November 28th issue of the Voice of America News, reports on a story from the World Health Organization regarding the growing issue of malaria drug resistance in Asia primarily caused by adulterated, fraudulent, sub-standard and counterfeit medications.

Highlights from the Voice of America News article include:

• World Health Organization officials say there are signs of growing drug resistance to mosquito-borne malaria, raising concern millions of people in Asia may be at risk.

• The Asia region accounts for more than 60 per cent of the global population at risk of the parasite with the main focus on India, Burma, Bangladesh, Indonesia and Papua New Guinea.

• But World Health Organization officials point to troubling signs a current drug combination based on artemisinin, originally drawn from a Chinese herb, is losing its potency against the malaria parasite.

• Artemisinin is largely given to patients in combination with other drugs rather than by itself in a bid to preserve the drug's long term effective strength.

• "The place where we are really concerned is on the Cambodian-Thai border," said Eva Marie Christophel a World Health Organization official in the Phillipines. "It would be disastrous if that spread because there's hardly anything in terms of new drugs in the pipeline for malaria or what is in the pipeline will take years, so we're really very much relying on arthemisinin based combination therapy."

• The World Health Organization is concerned that drug resistance could spread from the Cambodian-Thailand border region to Africa, following a similar pattern with anti-malaria drugs such as cloroquine and sulfadoxine-pyrimethamine in the 1960s and 1970s.

• In February 2009, WHO confirmed anti-malarial resistance at the Cambodian-Thailand border. But recent WHO studies found up to 20 per cent of patients at the Burma-Thailand border also showed signs of malarial parasites in the blood after the normal artemisinin combination therapy.

• "We noticed years ago that the disappearance time for parasites to disappear from the blood is increasing. Usually they disappear in two days or less," said Dr. Charles Delacollette, coordinator of the Bangkok-based WHO Mekong Malaria Program. "And we observe that there are an increasing proportion of patients showing parasites, still parasites in their blood after two days of artemisinin treatment, which was not the case before."

• Dr. Delacollette says the growing drug resistance is in part due to the sale of substandard and counterfeit drugs. In recent years, authorities cracked down against illegal factories in China. Meanwhile, counterfeit producers have been found elsewhere, including Cambodia and Burma.

• "Drugs are not quality, the quality of the drugs sold in private sector is selling any kind of drugs which are stored in very bad conditions, so they becoming substandard and also you have sellers which are selling counterfeit - purposely made counterfeit," said Dr. Delacollette.

The crime of adulterated, fraudulent, sub-standard and counterfeit drugs is a dangerous threat to populations around the globe.

To think that unscrupulous organized gangs can impact the health and well being of populations around the globe, especially for diseases and maladies that have long since been conquered by the advances in medical science is unconscionable.

Unfortunately the issue with malarial drugs is just the beginning of a much larger issue of drug resistant strains of diseases around the world. Drug resistant diseases know no borders and impact all societies, rich and poor.

The global supply chain must take proactive measures to protect their inventories from this insidious crime by deploying solutions to track and authenticate their inventories.

To read the entire Voice of America News story, visit: http://www.voanews.com/english/news/WHO-fears-growing-malaria-drug-resistance-may-be-spreading---110934814.htmlmalaria-drug-resistance-may-be-spreading---110934814.html

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

North Carolina Man Charged with Conspiring to Sell Fake Viagra

A 54-year-old North Carolina man was indicted Thursday for transporting and selling hundreds of counterfeit erectile dysfunction pills.

Cleve R. Wootson Jr. in the December 16th issue of the Charlotte Observer, reports on the story of a North Carolina man charged with conspiring and traffic of bogus medications.

According to the Charlotte Observer story:

• Federal authorities say Awni Shuaib Zayyad, 54, of Wilson, has been charged with several counts of trafficking in Viagra and Cialis and with conspiracy to sell counterfeit drugs.

• The U.S. Attorney's Office says he sold more than 500 fake Viagra pills on May 25. In August, authorities say, he transported 600 fake Viagra pills and 226 counterfeit Cialis pills.

• If convicted, Zayyad faces a maximum of 10 years in prison for trafficking and five years for the conspiracy. He also faces a total fine of $7 million.

This arrest is a good sign that law enforcement and industry in the United States is becoming more active in pursuing criminals engaged in the potentially lethal felony.

For too long now, counterfeit drugs has taken a back seat in enforcement and public awareness.

Hopefully consumers and the pharmaceutical supply chain will become more aware and proactive in their approach to dealing with fraudulent, adulterated, sub-standard and counterfeit medications.

To read the entire Charlotte Observer story, visit: http://www.charlotteobserver.com/2010/12/16/1915936/nc-man-charged-with-conspiring.html#ixzz19RArld6L

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

Counterfeit Drugs More Deadly Than Terrorism

“While 65,000 people have died in the past 40 years as a result of terrorism, fake medicine has killed 200,000 people in China in one year alone.”

Interpol Secretary-General Ronald Noble quoted in a presentation at an anti-counterfeiting conference in Africa.

Thieves Commandeer Pharmaceutical Delivery Truck and Abduct Driver

Police report of another pharmaceutical shipment hijacked by gunmen.

The Baltimore Sun reports on the story of a pharmaceutical delivery driver who was abducted December 13th while making his deliveries in Baltimore by thieves who made off with a truckload of drug products

Highlights from The Baltimore Sun article include:

• Police called the morning heist “incredibly thought-out,” and were looking for three suspects.

• The 55-year-old driver was forced at gunpoint into the back of his delivery truck and transported to an unknown location where the suspects unloaded about 80 crates of drug products.

• “The value of the drugs is significant,” said Baltimore Police spokesman Anthony Guglielmi, who said he could not place a dollar figure. “We believe the individuals responsible might have had knowledge about where and when the truck was going to be.”

• Guglielmi said police were in contact with the local FBI and DEA.

Clearly theft of prescription pharmaceuticals is proliferating given the high value and additional profitability of both the product and their packaging.

Organized criminal gangs are seizing the high profits and relative low risk in the criminal activity of pharmaceutical theft and drug counterfeiting.

The crime is has a double return to the criminal-prescription drugs are a valuable commodity and their packaging, used in the introduction of fraudulent, adulterated or counterfeit goods carries equal significance.

Members of the pharmaceutical supply chain must be on guard to protect their inventories from theft and fraudulent, adulterated, sub-standard and counterfeit drugs.

Consumers need to be made more aware of the prevalence and danger of bogus medications.

To read the entire Baltimore Sun article, visit: http://weblogs.baltimoresun.com/news/crime/blog/2010/12/thieves_commandeer_pharmaceuti.html

To learn more about pharmaceutical supply chain safety solutions, visit: http://www.xstreamsystems.net/

SecuringPharma: Survey Results Suggest Drug Counterfeiting is on the Rise

A survey of 1,000 specialists in pharmaceutical anti-counterfeiting measures surveyed have suggested that faking of medicines will become increasingly severe in the coming years, and that drugmakers will invest more in defensive measures.

SecuringPharma, in a December 24th post, reports on a survey that was created as a part of the pre-conference research for IQPC's Pharmaceutical Anti-Counterfeiting conference to be held in Amsterdam on February 15th-17th.

According to the SecuringPharma post:

• Almost two third of those polled in the survey (61.5 per cent) expected the threat of counterfeiting to increase in 2011, while more than half (53.8 per cent) said they were planning to increase their budget for investment in anti-counterfeiting area.

• With regard to the anti-counterfeiting technology they were using, just 53 per cent indicated they were satisfied with it and 23 per cent said they were not content with their current protection.

• A vast majority (84 per cent) said that they were looking to invest in new anti-counterfeiting measures, according to Pharma IQ, a division of conference organiser IQPC which carried out the poll.

• Emerging markets in Asia - and especially China - were perceived as the major source of the anti-counterfeit drugs by half of the respondents.

• 21 per cent cited the Internet as the major threat for the pharmaceutical market in the context of counterfeiting, with around the same proportion identifying organised crime as their top concern.

• On a positive note, while the results indicated that the perceived threat of counterfeit medicines was significant, most of those polled (84.6 per cent) said they believed it is possible to win the war with pharmaceutical counterfeiters.

The results of the survey are in line with all of the most recent media reports and statistics that are emerging at the close of 2010. The criminal enterprise of drug counterfeiting is on the rise and the threat to supply chains and populations around the world is very real.

Of comfort is the increased realization and reaction by governments, industry and consumers of this threat. In the past most members of the supply chain were looking for government mandates before moving to protect their inventories. Based on this survey it would appear that they are now in a more proactive mindset.

Ultimately it is incumbent on the supply chain members and the consumer to be vigilant in protecting themselves from this threat.

To read the entire SecuringPharma post, visit: http://www.securingpharma.com/40/articles/815.php

To learn more about the IQPC Pharmaceutical Anti-Counterfeiting Conference, visit: http://www.pharmaceuticalanticounterfeiting.com/Event.aspx?id=405182

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

Happy Holidays from Secure Pharma Chain Blog

The Team at Secure Pharma Chain Blog wishes everyone a Happy Holiday and a Prosperous, Safe and Secure New Year!

The Fake Drug Menace

In China Counterfeiters are turning out bogus 'life-saving' medicines.

In Part 1 of a two-part special report, Straits Times correspondent Grace Ng focus on the huge underground trade in China of fake pharmaceutical drugs and the dangers it poses to the population.

Ms. Ng writes an excellent essay with personal stories, statistics and examples of the danger posed to the consumer.

Some of the highlights of Ms. Ng’s story include:

• The estimate from the US-based Centre for Medicine in the Public Interest shows global sales of counterfeit drugs almost doubling in the past five years.

• The World Health Organisation also believes that in some developing regions, more than 30 per cent of medications sold are fake. Online retailing has only made it worse: As much as half of what is offered online could be fake.

• Interpol secretary-general Ronald Noble has described this trade as more deadly than terrorism. While 65,000 people have died in the past 40 years as a result of terrorism, fake medicine has killed 200,000 people in China in one year alone, he said at a recent conference on anti-counterfeiting in Africa.

• The world's second largest economy [China] is also one of the main sources - possibly the biggest - of counterfeit drugs.

• A significant share of the revenue from the global sale of fake drugs is pocketed by Chinese manufacturers, who are becoming increasingly savvy in exploiting online sales and technology to grow their business.

• Chinese counterfeiting syndicates used to make most of their money from sales in Africa, inundating countries like Nigeria with fake anti-malarial drugs that were labeled 'Made in India'.

• Investigations have also revealed the technological savviness and sophistication of Chinese manufacturers. Not only do they have the laser printers and chemical labs to churn out perfect replicas of genuine drug packaging, down to the holograms, but they are also using major websites to market their wares aggressively.

As this outstanding article points out, China has become the epicenter of bogus medications and the threat to consumers’ world wide continues to grow.

Consumers around the globe must be made aware of the very real threat to their health and well being while members of the pharmaceutical supply chains must take proactive efforts to protect their brands and inventories.

To view the entire Straits Times story, visit: http://admpreview.straitstimes.com:90/vgn-ext-templating/v/index.jsp?vgnextoid=29b07cac3afec210VgnVCM100000430a0a0aRCRD&vgnextchannel=f511758920e39010VgnVCM1000000a35010aRCRD


To learn about solutions used to combat counterfeit medications, visit: http://www.xstreamsystems.net/

Pharmacists Caught Selling Fake Viagra

Fake Viagra Imported from China.

Park Si-soo in the Korea Times reports on a group of pharmacists in Seoul, South Korea who were charged with selling counterfeit drugs.

According to the Korea Times article:

• A group of pharmacists were caught selling fake Viagra pills imported from China.

• The Seoul Metropolitan Police Agency said 15 pharmacists were booked on suspicion of selling the fake pills that could cause consumers to die of a heart attack in the worst case.

• Each pill was purchased for 2,000 won and resold to consumers for 15,000-18,000 won each.

• Experts called for a tough crackdown on the circulation of fake Viagra pills.

• Offenders without a prior criminal record face a fine of up to 5 million won or a business suspension for up to 15 days.

Clearly the selling of dangerous, potentially deadly counterfeit drugs by healthcare professionals to their unsuspecting patients is troubling.

Especially troubling is the light penalties for those convicted of this potentially lethal criminal act.

When pharmacists, healthcare providers or members of the supply chain have few legal barriers or no imposing penalties to protect their inventories from bogus drugs, the potential for the introduction of fraudulent, adulterated, sub-standard and counterfeit drugs into the legitimate pharmaceutical supply chain increases significantly.

The proliferation of fraudulent, adulterated, sub-standard and counterfeit drugs has become one of the most lethal criminal acts and healthcare epidemics in the 21st century. All members of the pharmaceutical supply chain-regulators, raw material providers, manufacturers, distributors and providers-must take proactive steps in protecting the consumer from these lethal fakes.

To read the entire Korea Times article, visit: http://www.koreatimes.co.kr/www/news/nation/2010/12/113_77963.html

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

Details on the Memphis Pharmaceutical Distribution Center Hijacking

Two men are in custody, one man still at large in hijacking that occurred early Friday.

According to an article written by Scott Carroll which appeared in the December 19th edition of the Memphis Commercial Appeal:

• Two men are in jail and another remains at large following a hijacking early Friday in which gunmen robbed eight employees and stole vans containing $200,000 worth of pharmaceuticals from a South Memphis distribution center.

• Ralph Jones, 22, and Patrick Dotson, 20, each were charged with eight counts of aggravated robbery, eight counts of aggravated kidnapping and one count of aggravated assault for the robbery of Hackbarth Delivery Service.

• The incident began around 5 a.m., as the loading dock doors were opening. The three gunmen confronted eight Hackbarth employees and demanded money, cell phones and personal items before forcing them to load three company vans with prescription drugs, according to a police affidavit.

• Employees told investigators they were then stripped of their clothes and locked in a fenced area.

• Hidden tracking devices embedded in the pharmaceutical products led police later that day to a house at 1279 College, where they recovered two of the vans and arrested Jones and Dotson.

• Dotson gave a statement of confession to police in which he implicated Jones, police said. Both are being held on bonds of $1 million.

• A Memphis Police Department spokesman said no information on the third gunman, who is still at large, was available Saturday.

The value of pharmaceutical drugs as both a high value commodity for their contents and for their packaging-which is used in drug counterfeiting-has made the theft of prescription drugs one of the more profitable and prolific crimes of the 21st century.

Consumers need to be made aware of the danger that this crime imposes on their safety and buy and consume medications only from known legitimate health care professionals.

Members of the supply chain need to take proactive measures to protect their inventories from theft, adulteration, fraud, sub-standard and counterfeit drugs.

To read the entire Commercial Appeal article, visit: http://www.commercialappeal.com/news/2010/dec/19/2-charged-in-theft-of-vans-full-of-drugs/

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

Drug Topics: Counterfeit Drug War Continues, Threatens Supply Chain

Kathryn Foxhall writes an outstanding article in Drug Topics on new efforts by federal authorities to attack the growing issue of counterfeit medications.

The article includes industry insight and relevant statistics. Highlights of Ms. Foxhall’s Drug Topics article include:

• To jump-start efforts to deal with supply-chain threats that include counterfeiting, economically motivated adulteration, diversion, and cargo thefts, FDA is creating a new Drug Integrity and Security Program within the Office of Compliance of the FDA's Center for Drug Evaluation and Research.

• FDA is developing standards for track-and-trace and authentication systems that would enable the identification of substandard prescription drugs as they move along the supply chain.

• The counterfeiters are winning the global counterfeit drug war, with counterfeit medications more abundant than ever before, according to Jeffrey Gren, director of the Office of Health and Consumer Goods in the U.S. Department of Commerce.

• According to FDA, Gren said, 80% of active pharmaceutical ingredients (API) in drugs consumed in the United States come from other countries, mostly from nations that don't have sophisticated regulatory regimes. An API, he said, "may come from China, it may be packaged in the Middle East, it may be sent through Brazil; ultimately it makes it to the United States or other parts of the world," making the problem difficult to solve.

• Nancy Kennedy, senior operations manager of drug investigations in FDA's Office of Criminal Investigations, said that some years ago imported, unapproved, and counterfeit drugs came into the United States addressed to individuals or packaged in small quantities. Then quantities increased, and counterfeits started going to drop-shippers and distributors working from online pharmacy operations. "Now we see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar-pharmacies— and these are for use and distribution directly to patients," Kennedy said.

• Kennedy said that for some time Congress and others have been saying, "Show us the bodies." But there may not be many bodies at one time, she said, unless an event occurs such as the mass poisonings that have happened in other countries.

With the pharmaceutical supply chain threatened by dangerous fakes from all over the globe, it is vital for the supply chain to take proactive steps to protect itself and not wait for regulatory mandates or law enforcement action.

Deploying technologies, solutions and best practices protect both the supply channel and the consumer.

Businesses that take these proactive steps will be able to differentiate themselves and will be in a prepared protected position when there is a large counterfeit drug incident within the supply chain.

To read the entire Drug Topics article, visit: http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Counterfeit-drug-war-continues-threatens-supply-ch/ArticleStandard/Article/detail/699610?contextCategoryId=40159

To learn about pharmaceutical supply chain solutions, visit: http://www.xstreamsystems.net/

FreightWatch: Armed Hijacking at Pharmaceutical Distribution Center

Gunmen hijack delivery vans at a pharmaceutical distribution center, police recover product and apprehend the suspects.

FreightWatch International, an industry leader in providing cargo theft intelligence released a news bulletin regarding the armed hijacking of a pharmaceutical distribution center.

According to the bulletin:

• Three armed men entered a pharmaceutical distribution facility as the dock doors were rolled up in the early hours of December 17, in Memphis, Tennessee.

• The armed men held 9 people at gunpoint and proceeded to drive away with three delivery vans full of product.

• Through the use of redundant covert tracking devices embedded in the pharmaceutical products, the suspects and product were tracked to a house where police were able to recover the product and apprehend several of the suspects.

Pharmaceuticals have become a valuable currency and organized gangs realize the high profitability in the theft, adulteration, fraud and counterfeiting of all medications.

All members of the pharmaceutical supply chain must take proactive steps to protect their inventories from theft, adulteration and counterfeited products.

To read the entire bulletin from Freightwatch International, visit:
http://www.freightwatchintl.com/

To learn more about pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/

36 Million Americans Have Bought Rx’s From Illegal Online Pharmacies

Tens of millions of Americans have bought medications online without a prescription, according to a new study.


Alaric DeArment in Drug Store News writes about a study funded by the Alliance for Save Online Pharmacies and released by The Partnership at DrugFree.org, which finds that illegal online pharmacies have sold drugs to 36 million Americans.

According to the Drug Store News story:

• Many independent and chain retail pharmacies operate websites and there also are reputable online pharmacies, such as Drugstore.com. However, a number of illegal online pharmacies also exist, and buying drugs from them opens consumers to the risk of taking counterfeit, adulterated or unapproved medications.

• “Those who sell prescription drugs online without a valid prescription are operating illegally, undercutting the laws that were put in place to protect patients, and are thereby endangering the public health,” U.S. intellectual property enforcement coordinator Victoria Espinel said. “It is a real wake-up call that so many Americans have engaged in this dangerous behavior.”

• At the White House Intellectual Property Health and Safety Forum on Tuesday, Espinel said 11 companies had joined to create a nonprofit group designed to target illegal online pharmacies, including American Express, Visa, MasterCard, PayPal, eNom, Google, Microsoft, Neustar, Network Solutions, Yahoo! and Go Daddy.

The purchase of drugs from illegal online sites is a dangerous practice that impacts the health and safety of entire consumer populations.

With these illegal purchases, the consumer is potentially bringing dangerous fakes into the legitimate supply chain. It is critical that all members of the legitimate pharmaceutical supply chain take measures to protect themselves from these dangerous sources of supply.

To read the Drug Store News story, visit: http://www.drugstorenews.com/article/companies-band-together-end-illegal-online-pharmacies

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

Illinois Man Charged in Counterfeit Drug Bust

Thousands of fake valium found in an Illinois business after FDA and CBP intercept a United States Postal Service package.

Authorities charged an Illinois businessman with unlawful possession of a controlled substance after authorities discovered a package, sent to his address, contained bogus drugs.

According to a report from Sun-Times Media story:

• Bond has been set at $30,000 for a Naperville man found in possession of thousands of counterfeit Valium pills, Cook County Sheriff Tom Dart’s office announced Monday.

• Amin Rupani, 40, of the 2600 block of Salix Circle in Naperville, has been charged with unlawful possession of a controlled substance, a release from the sheriff’s office said. He was arrested at his computer business, Precision Technologies.

• The Sheriff’s Police Special Operations Unit began its investigation into Rupani’s activities after the U.S. Food and Drug Administration, along with the U.S. Customs and Border Patrol, detained a package containing counterfeit Valium pills. The 20,000 pills packed inside plastic containers had Rupani’s business address, but a fake name.

• On Dec. 9, sheriff’s office investigators, along with agents from the FDA and the U.S. Postal Service, wired the Valium package with a monitoring and tracking device and conducted a controlled delivery to Rupani’s office. When officers received a radio transmission signal that the package had been opened, they entered the business and placed Rupani under arrest.

• Rupani told investigators he received the packages from a friend who lives in Karachi, Pakistan, and that he was told the pills were vitamins and weight loss drugs. Forensic tests of the seized pills show they contain the active ingredient in Valium, but they were manufactured by a criminal enterprise in China. The estimated street value of the drugs is $200,000.

• Rupani admitted he forwarded the packages sent by his co-conspirator to addresses in Texas and California on a regular basis, using his company’s UPS account. After a search of Rupani’s business, officers also recovered nine plastic bags containing an estimated 20,000 light green triangular pills, suspected counterfeit Xanax, and a box of diet pills.

Kudos to the FDA and CBP for the interception of this particular shipment but it begs the question as to the extent of the greater issue of these types of dangerous fakes within the pharmaceutical supply chain.

Certainly this particular bust must be but a tiny fraction of a much larger pipeline of counterfeit drugs that are introduced into the United States each day.

This type of crime is proliferating at an epic pace given the high profits and extremely low risk of getting caught or doing time. In this particular instance because the fakes were of a controlled substance, the suspect may be in for a significant penalty, however those that fake prescription drugs like Viagra have fewer penalties.

Members of the legitimate pharmaceutical supply chain must take proactive measures from these types of deadly fake products ending up in their inventories.

To read the entire Sun-Times Media story, visit: http://napervillesun.suntimes.com/news/crime/2828874-418/rupani-pills-valium-business-office.html

To learn more about anti-counterfeiting technologies for the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/

Freightwatch International: November 2010 Cargo Theft Report

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released their monthly report on cargo theft for November 2010.

FreightWatch recorded 70 incidents in November. Prior to the Holiday season, Electronics and Food/Drinks continue to be the most stolen commodities.

By location, California, New Jersey and Texas accounted 64% of all the thefts recorded in November with 28, 11, and 6 thefts respectively.

This month, an average loss value of $642,371 resulted from the 24 incidents that contained an estimated load value.

On November 10, a load of pharmaceuticals worth $10.9 million was stolen a few miles away from its point of origin. The driver left the load unattended for approximately 15 minutes when it was stolen.

The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.

To read the entire report from Freightwatch International, visit:
http://www.freightwatchintl.com/

To learn more about pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/

FDA: Don’t “Man Up Now”

FDA issues warning against supplement marketed for sexual enhancement which contains potentially dangerous ingredient.

In a government recent press release the U.S. Food and Drug Administration is warning consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

Man Up Now claims to be “herbal” and “all natural,” and consumers may mistakenly assume the product is harmless and poses no health risk.

Consumers who have Man Up Now capsules should stop using them immediately. The FDA analyzed Man Up Now and determined that it contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply that can lead to dizziness or lightheadedness.

Man Up Now, distributed by Synergy Distribution LLC, is sold on Internet sites, online marketplaces, and possibly in retail outlets in single, double, and triple blister packs, and in six-, 12-, and 30-count capsule bottles.

Consumers should take great care when purchasing or taking dietary supplements products, the FDA has found many products marketed for sexual enhancement can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients.

To read the FDA Press Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm236538.htm

Holiday Cargo Theft: A Concern for the Pharmaceutical Supply Chain

During the seven major holidays in the United States, cargo theft rates increase by 28% on a per-day basis compared with the remaining calendar days.

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released a report outlining the statistics and concern over the increase of cargo theft during the holiday season.

The FreightWatch report analyzes the statistics supporting this commonly understood maxim in an attempt to better explain the increased risk faced by shippers and their supply chain providers.

By commodity, pharmaceutical thefts increases from 6% to 8% during the holiday.

It is critical that all members of the supply chain protect their inventories from theft, adulteration, fraud, and counterfeiting through increased vigilance and by deploying solutions and technologies.

To read the FreightWatch International Holiday Cargo Theft report, visit: http://www.freightwatchintl.com/?q=webfm_send/31

Fake Drug Factory Seized

Bangladesh’s BDNews24 is reporting that several fake counterfeit drug factories have been raided and closed this week by authorities.

According to the December 7th report in BDNews24:

• The Rapid Action Battalion has sealed a fake drug factory and arrested three people in a special drive at Babubazar Bhuiyan Medicine Market in the capital.

• Magistrate A B M Anwar Pasha told bdnews24.com that they seized fake drugs worth Tk 500,000 conducting the special raid at Lakkhi Drug House and Joy Corporation of Bhuiyan Medicine Market on Tuesday and arrested three in this connection.

• Pasha alleged that the arrestees used to manufacture fake drugs rapping covers [packaging labels] of different well-known drug companies and release those in the markets.

• The RAB on Monday also sealed a fake drug factory at Nagarzanj of Keraniganj Upazila in Dhaka.

With its proximity to China and India and its stifling poverty, Bangladesh’s population is significantly impacted by the proliferation of counterfeit medications within its pharmaceutical supply chain.

It is encouraging that authorities are taking proactive action against the criminal elements that are attempting to insert their fakes into the legitimate supply. It is especially important to interdict the point of production to keep these lethal fakes from impacting the health and well being of millions. Apparently these were organizations posing as legitimate businesses that were selling their fakes into traditional medication markets.

To read the entire news story, visit: http://bdnews24.com/details.php?id=180957&cid=2

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

The Recalls Keep Piling Up for J&J

McNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF ALL LOTS OF ROLAIDS® EXTRA STRENGTH SOFTCHEWS, ROLAIDS® EXTRA STRENGTH PLUS GAS SOFTCHEWS, AND ROLAIDS® MULTI-SYMPTOM PLUS ANTI-GAS SOFTCHEWS SOLD IN THE UNITED STATES

No sooner had Secure Pharma Chain posted it blog from Pharmalot but comes more bad news from the pharmaceutical industry giant.

In a seemingly never-ending story, Johnson & Johnson’s embattled McNeil Consumer Healthcare unit has issued yet another recall, this time for its ubiquitous Rolaids brand.

It remains to be seen how many hits to its venerable brands can the industry giant take and retain its trust regarding the safety and efficacy of its respected and ever-present products with consumers.

J&J explains the recall in its press release with the following:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

J&J is feeling the immediate financial impact of the loss of sales, expense of recalls and operational expenses. The long term impact in liabilities, brand erosion and loss of consumer confidence will continue to accrue for many years to come.

Members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should take heed from the woes of J&J. Testing and protection of the brand and inventories from poor quality, fraud, adulteration and counterfeiting does not stop at any one point of the supply chain process. Measures must be deployed at all stops of the supply chain to test the quality and authenticate that the product being consumed is safe and efficacious.

To read the entire official J&J Press Release regarding the recall and its details, visit: http://www.rolaids.com/page.jhtml?id=rolaids/include/recall_dec.inc

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

Pharmalot: The Sorry List of Johnson & Johnson Troubles

“We now see a strong likelihood of near-term FDA enforcement action.”

Once again Ed Silverman in his Pharmalot blog outlines the issues that have plagued the pharmaceutical industry giant over mandated recalls, “phantom recalls”, other regulatory misdeeds that have impacted their venerable brands including Tylenol, Mylanta, Motrin, Rolaids and Benadryl.

In his blog, Mr. Silverman cites Wells Fargo Securities analyst Larry Bigelsen regarding the potential impact of continued FDA scrutiny on their operations and to J&J stock.

This blog presents some interesting, whimsical insight into the depth of the problem and the potential impact operationally and financially to J&J.

Secure Pharma Chain sees this as a cautionary tale to the pharmaceutical supply chain- protect the production, quality, efficacy and distribution of your product and inventories within the supply chain or risk the reputation and viability with the consumer. The stakes are high and the consequences to the brand and the consumer can be lethal.

It is vital that all members of the pharmaceutical supply chain deploy and utilize technologies that protect consumers from adulterated, fraudulent, sub-standard, poor quality and counterfeit drugs.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/12/the-sorry-list-of-johnson-johnson-troubles/

To learn more about pharmaceutical authentication technology, visit: http://www.xstreamsystems.net/.

Court Told of Multi-Million Pound Medicines Scam

“This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,”

The Tuesday, December 7th edition of the Bath Chronicle reports on the court case of five accused of a multi-million pound pharmaceutical plot involving bogus Chinese-manufactured life-saving drugs.

According to the Bath Chronicle story:

• A jury was told the people behind Europe’s biggest ever scam of its kind were motivated by “pure greed.”

• The court was told that as a result of the scam, medicine watchdogs ordered a recall of all suspected drugs – taken by heart and cancer patients and people with mental health problems – resulting in shelves being cleared in pharmacies all over the country.

• “They were prepared to make profits by feeding duff drugs to people with serious illnesses, prostrate cancer, heart disease and psychiatric issues,” prosecutor Andrew Marshall told Croydon Crown Court.

• All five have pleaded not guilty to conspiring between January 1, 2006 and June 30, 2007 together and with others to defraud pharmaceutical wholesalers, pharmacists, the public and holders of intellectual property rights in pharmaceuticals by dishonestly distributing for gain counterfeit medicines.

• Charges were brought following a two-year investigation by the Medicines and Health Care Products Regulatory Agency, part of the Department of Health, into Consolidated Medical Supplies Ltd.

• The company, of Unit 14, Sherrington Way, Lister Road, Industrial Estate, Basingstoke, had its wholesale dealer’s licence revoked by the agency on January 8, 2008.

• “This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,” Mr Marshall told the jury.

• “The most serious in the European Union, with far-reaching effects for pharmaceutical companies, patients and the confidence of the general public.

• “The purpose is just greed. To obtain the profits of buying illegal goods cheaply.”

• The charges relate to ‘Casodex‘, used to treat advanced prostate cancer, ‘Plavix‘, a drug prescribed to prevent blood clots and prevent heart attacks for angina patients and ‘Zyprexa’ a anti-psychotic drug prescribed to schizophrenic and bipolar patients.

• “They are just importing danger,” Mr Marshall told the jury. “The drugs imported are not extensively and expensively tested, but instead have been smuggled into the EU and distributed regardless of their chemical qualities.”

• The drugs were said to be manufactured by a notorious Chinese pharmaceutical counterfeiter currently serving a prison sentence for a similar scam in the United States.

• “No one pretended these were cheap counterfeits, they were pretended to be real. These men are not a charity importing cheaper drugs, it is I am afraid, pure greed in order to make money, working totally outside the system.

Hopefully the pharmaceutical supply chain and consumers will use this story to educate themselves about the danger that counterfeit drugs pose, even in sophisticated health care delivery systems within developed nations.

There are bad guys everywhere that realize that huge profits with little risk are involved in the sale of bogus medications.

Secure Pharma Chain encourages all within the regulatory and supply chain to take measures to protect their constituents from fraudulent, adulterated, sub-standard and counterfeit medications.

To read the Bath Chronicle article, visit: http://www.thisisbath.co.uk/health/Court-told-multi-million-pound-medicines-scam/article-2976972-detail/article.html

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

‘Made in India,’ Faked in China

China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Roger Bate a Legatum Fellow at the American Enterprise Institute and Tom Woods President of Woods International write an excellent article in The American, the Journal of the American Enterprise Institute about the huge role that China is playing in polluting the pharmaceutical supply chains around the globe by producing massive amounts of fake drugs that often times with lethal consequences.

Mr. Bate, a long time favorite of Secure Pharma Chain, along with Mr. Woods once again provides insightful analysis into one of the most insidious and deadly crimes of the 21st century.

Highlights of The American article include:

• Chinese manufacturers are faking drugs, endangering patients' lives, and undermining legitimate brands, especially those from India. Indian companies provide vast amounts of generic drugs to mid-income and developing nations. By some estimates, 80 percent of HIV drugs for the developing world come from India, and probably half the anti-malarials and antibiotics, too.

• From the counterfeiters' perspective, faking Indian drugs makes sense. Even in those categories where Indian products do not dominate the market, they may still be copied. In part this is because Western brand owners are more likely to go after those faking their brands, whereas Indian drug makers have smaller margins and hence spend less on brand enforcement.

• Criminals often manage to bypass… inspections by inserting their fake versions further along the distribution chain. So more often tip-offs from underworld contacts, probably disaffected parts of criminal networks, provide the greatest likelihood of intercepting fakes.

• Of course, sometimes the fakes make it to market, often with lethal effect. In 2009, our Nigerian colleague Thompson Ayodele came across another fake of an Indian drug in a Lagos pharmacy, this time an antibiotic. Later, we found out it too had been made in China. It is impossible to know how many patients had taken this fake antibiotic before authorities were alerted.

• Chinese gangs do not discriminate—every major drug company and every country has probably had drugs faked by the Chinese. China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. In fact, Chinese operators will fake in or for any location and they will fake anything popular. Take Artesunat, the brand of a Vietnamese anti-malarial made by the Ho Chi Minh–based company Mekophar Chemical Pharmaceutical, which is also widely faked. Ongoing research shows that fake Artesunat was found in Nigeria, Ghana, Kenya, Uganda, Tanzania, and Thailand; and it was all the handiwork of Chinese counterfeiters.

• Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Clearly China has become the primary incubator and exporter of the counterfeiting drug trade which now stretches beyond the globe. China must do more to protect supply chains from a criminal act that can cause death and create health care catastrophes among entire populations. All members of the pharmaceutical supply chain must take proactive steps to interdict and eradicate these deadly fakes and protect the consumer.

To read Mr. Bate and Mr. Woods article, visit: http://www.american.com/archive/2010/december/made-in-india-faked-in-china

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

Pharmaceutical Counterfeiting: The Effect of Technology, Regulation, and Legislation on Manufacturer Liability

“As more technologies become available and affordable, plaintiffs will contend that companies not employing technological protections—especially for drugs highly likely to be counterfeited—breach some duty to consumers.”

Caitlin Blanche an Associate with Snell & Wilmer out of Orange County, writes an outstanding essay in the American Bar Associations Mass Torts, Winter 2010 edition regarding the legal and liability perspective of the pharmaceutical supply chain stakeholder and the overall issue of pharmaceutical supply as it relates to fraudulent, adulterated, sub-standard and counterfeit drug.

While clearly written for a pharmaceutical industry General Counsel, Ms. Blanche’s article should be a must read for all industry insider’s as they look at dealing with one of the most insidious threats to the pharmaceutical industry and health care consumers at large.

Ms. Blanche outlines the issue, discusses relevant technologies/solutions and reports on regulatory initiatives while concluding with:

"Now, more than ever, attorneys should counsel clients about supply chain management, internal audits, the careful analysis and adoption of track-and-trace and anti-counterfeit technology, remedial measures, and monitoring of all relevant legislation introduced. Although courts have not yet imposed common-law liability for drug counterfeiting, there are a number of evolving variables in play, and plaintiffs could use any one of them to allege a new standard of care for manufacturers."

Secure Pharma Chain endorses Ms. Blanche's conclusions and encourages all within the supply chain to take proactive steps to secure their inventories from adulterated, fraudulent, sub-standard and counterfeit medications.

To read Ms. Blanche’s essay visit: http://www.swlaw.com/assets/pdf/news/2010/12/01/ABAMassTortsPharmaceuticalCounterfeiting_Blanche.pdf

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

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/