WHO: Fake Drugs Major Factor in New Malaria Strain

The World Health Organization (WHO) raised the alarm about a new strain of drug resistant malaria in South East Asia.

According to SafeMedicines, a newly published report on antimalarial drug efficacy and resistance, scientists believe that fake and substandard malarial medications are a major factor in the development of new drug-resistant strains of malaria.

According to SafeMedicines:

• Resistance to artemisinin has emerged along the border of Cambodia and Thailand, and WHO is putting together a global panel of stakeholders to work to contain this new strain before it spreads to Africa, as other strains did in the 1960s and 1970s. Scientists believe that once a new strain occurs through spontaneous change in the parasite, its ability to survive is promoted by substandard medications.

• Current containment activities involve long-lasting insecticide-treated mosquito nets, recruitment and training of village health workers equipped with rapid diagnostic tests, and most importantly free malaria treatment and follow-up. Free treatment is key to the success of the containment effort because “free treatment and care helps to undermine the sale of counterfeit and substandard antimalarial drugs,” states WHO in the “Global Report on Antimalarial Drug Efficacy And Drug Resistance: 2000-2010.

• “Efforts have also been made to stop the sale of counterfeit and substandard drugs, which are a major factor in the development of resistance,” states the report.

• WHO’s report states that the Cambodian government is working closely to monitor malarial medications and educating consumers in workshops and through reading materials on the extensive dangers fake malaria drugs may cause them.

• “History has shown that once resistance to antimalarial treatment emerges it is only a question of time before it spreads. For the first time, the global malaria community has the opportunity to contain resistance before it spreads,” states the report.

• Artemisinin is a plant-based antimalarial medicine, which due its potency very quickly reduces the number of malaria parasites in humans. Artemisinin compounds are combined with other anti-malarial drugs in therapies called artemisinin-based combination therapies (ACTs). Using combination therapies provide multiple possible agents to kill the plasmodium parasites that cause malaria.

Drug resistant diseases know no borders and effect wealthy and the poor.

Counterfeit drugs have become one of the most insidious criminal and health care epidemics of the 21st century.

All members of the global pharmaceutical supply chain (manufacturers, distributors, regulatory agencies, dispensers and consumers) must insist on it members to use all laws, solutions and technologies to fight this lethal crime.

To view the entire SafeMedicines post, visit: http://www.safemedicines.org/2010/11/fake-drugs-major-factor-in-new-malaria-strain-says-who-49.html

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

Counterfeit Drugs Causing Drug Resistant Strains of TB

The proliferation of counterfeit drugs used for the treatment of tuberculosis in Africa is causing the rise of extremely resistant strains of TB.

Jeff Otieno reports in the Daily Nation on September 27th about an already serious health care problem becoming much more serious due to substandard, adulterated, fraudulent and counterfeit medications.

The major concern is that while easily and inexpensively treated TB can grow into an un-manageable disease when the drugs used to counter it are counterfeit.

As reported in the Daily Nation:

• Treatment drugs are becoming weaker by the day. Such is the case with two types of tuberculosis, multi-drug resistant TB and extremely resistant TB, which are on the rise not only in the East Africa, but also globally.

• “Drug resistant tuberculosis cases are spreading. We have already seen a rise in Kenya and we believe the case is the same in other parts of East Africa,” says Dr Joseph Sitienei, the head of the National Leprosy and Tuberculosis Control Programme.

• Extremely resistant TB is caused by poor treatment, mis-diagnosis and the unwitting use of counterfeit drugs. It is a case where a normal TB disease transforms itself becoming resistant.

Populations around the globe should be concerned because drug resistant strains of diseases transcend borders and quickly spread beyond underdeveloped nations.

Counterfeit medications are increasingly becoming one of the most dangerous health care issues of the 21st century.

To read the entire Daily Nation article, visit: http://www.nation.co.ke/News/Spread%20of%20resistant%20tuberculosis%20fails%20to%20catch%20world%20attention%20/-/1056/1019204/-/10aq73p/-/.

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

Sudan Combats Sale of Counterfeit Drugs

Countries in Africa continue to fight the incredibly deadly crime of counterfeit medications which attacks and kills many within underdeveloped nations.

The following story comes from the August 7th edition of the Sudan Tribune and describes how the Sudanese government wages a war against counterfeiters who blatantly shop their dangerous wares on an unsophisticated population.

In Africa, where counterfeit medications can make up over 50% of a nation’s pharmaceutical supply chain, the issue of bogus drugs is at epidemic proportions and its impact on the health and well being of these populations is increasingly more deadly.

Consumers in developed nations should not feel comfortable that they are immune from the dangers of these criminal acts.

Because of huge profits, the likelihood that they will avoid legal punishment and without consumers or regulatory agencies on guard against it, counterfeiters are even more incentivized to ply their deadly inventories within developed nation’s legitimate supply chains.

The following are the highlights from the Sudan Tribune article:

· A megaphone atop a double cabin land cruiser roamed Luonyaker main market on Friday warning customers that some unscrupulous persons have flooded most of the rural towns with fake medicines purportedly to cure all diseases.
· In Southern Sudan, even those selling fake drugs are vulnerable to counterfeiting. Wol Kon Laau, head of Yiik Adoor Primary Health Care Unit in Gogrial East County, Warrap State, said the common use of counterfeit or sub-standard pharmaceuticals means many patients wait too long to seek proper medical attention.
· "As a practitioner I have had examples to give. I encountered most of them when I was practicing as a medical student that certain drugs were brought in into the system even in the normal delivery system which were of low quality and it even becomes worse with the drug peddlers who are going about villages killing people," he added.
· A salesman without medical background says his Capsule cures high blood pressure, arthritis, kidney disease, premature menopause, cardiovascular disease, and infertility, saying it might be correct but this requires prescription from medical practitioners not by assumption.
· "Fake and counterfeited products usually involve products that are either high volume or high cost. So you look mostly at anti-Malarial currently the Artemisinine combination therapy. In addition to that there are products for erectile dysfunction and because these are often sold at pubs and places where people try to get them without prescription they go for high value, they go for high cost," he explained.
· "With me in the committee we go on the market. We sample products, and we publish the results so that we can name and shame. We hope that within 18 months Southern Sudan in general and Warrap state in particular should be able to have very decent data on the extent of the quality problem in the area," said Laau.
· He says that this will give health officials a better sense of the scale of the problem and allow for the eventual prosecution of those purposely endangering public health.

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

To read the entire Sudan Tribune article, visit: http://www.sudantribune.com/spip.php?article35875.

Six Chinese Sentenced to Death for Selling Fake Drugs Labeled “Made in India”

Six Chinese traders who exported fake anti-malaria drugs to Africa Labeled as “Made in India” have been sentenced to death. Chinese officials have offered apologies to India, but no further information on the traders’ identities was given.

The issue became a major controversy last June when Nigeria's National Agency for Food and Drug Administration and Control said it had seized a large consignment of spurious anti-malaria drugs worth $210,000.

Indian officials had received complaints that drugs exported from China but mislabeled as manufactured in India were being exported to South Africa, Ghana, Ivory Coast and other parts of Africa.

To view the entire article visit: timesofindia.indiatimes.com.

Counterfeit Malaria Drugs Responsible for Thousands of Deaths throughout Africa

According to the September 13th issue of Media Global, a global media outlet based in the United Nations Secretariat, the World Health Organization has revealed some disturbing statistics as it relates to the deathly impact of counterfeit medications in Africa. Some of the most revealing and interesting portions of the article are:

• The World Health Organization (WHO) has increased efforts to fight the distribution and manufacture of counterfeit malaria drugs in Africa.



• According to the World Health Organization, upwards of 2,000 children per day die as a result of taking these counterfeits medications.



• Due to their high demand and price, malaria drugs are a prime target for counterfeiters.



• Many of these counterfeits contain little to no active ingredients or even the wrong active ingredient. The active ingredient may temporarily soothe the symptoms but have no real effect on the disease itself.



• "There is usually a low amount of active ingredient, like the pain reliever paracetamol, in fake malaria medications,” according to Dr. Lembit Rago, Coordinator of WHO Essential Medicines and Pharmaceutical Policies," in order to “cheat qualitative screening tests that just react to the presence of certain actives, and thus may mimic false positive results.”

Although known to many within global health organizations and those with insight into the issue of counterfeiting the death toll and scope of the issue is nonetheless shocking. The insidious nature of counterfeit drugs and the cost in human life should be galvanizing and accelerating industry and governments around the globe to combat this plague before it continues its proliferation around the globe.

XStream Systems and its EDXRD technology offer a solution to this issue by being able to screen and test materials within their unit of sale, penetrating through the packaging and being able to do a complete molecular screening of the product (active ingredients, excipients, dosage) without destroying or degrading the medication.

To read the Media Global article, ("Counterfeit Malaria Drugs Kill Thousands in Africa," Media Global, September 13, 2009), visit: mediaglobal.org.

To learn more about XStream Systems, visit: www.xstreamsystems.net.

Baltimore Pharmacist Charged with Fraud in Counterfeit Drug Case

1,700 pounds of suspected counterfeit drugs was found in two Medicine Shoppes in Maryland last year - In addition, the owner is being charged with Medicare and Medicaid fraud.

A year ago we wrote regarding two Medicine Shoppes in the Maryland area that had been cited for having expired drugs on their shelves. This, however, does not even begin to tell the true story of expired drugs, counterfeit drugs, Medicare and Medicaid fraud, and the exportation of these drugs to Africa.

Pamela Arrey, a Maryland pharmacist, has most recently been charged with Medicare and Medicaid fraud. She is accused of charging about $350,000 to the federal insurance programs for drugs she never dispensed. In fact in some cases she billed for prescriptions the patients did not even request.

Last July, she was charged with mislabeling and selling counterfeit drugs when nearly 1,700 pounds of suspected counterefeit drugs were found at one of Arrey’s two Medicine Shoppes in Maryland. The durgs valued at $749,000, were medications to help epilepsy patients control seizures. Mislabeled, expired and suspected counterfeit drugs, including those designed to help fight breast cancer, were also found at Arrey’s second Baltimore Medicine Shoppe.

In August of last year, the Food and Drug Administration(FDA) issued a press release warning to consumers who purchased prescriptions from Arrey’s pharmacies that the following drugs could be expired or counterfeit:

* Lisinopril (20 milligrams)
* Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
* Gabapentin (100 mg, 300 mg and 400 mg)
* Metoprolol (50 mg)
* Nifedipine (30 mg)
* Diclofenac Sodium (30 mg)
* Glucophage (500 mg Extended Release)
* Glucovance (125 mg and 500 mg)
* Glipizide/Metformin (2.50 mg/250 mg)
* Furosemide (20 mg)
* Tamoxifen Citrate (10 mg)
* Metformin HCl ER (500 mg)
* Calcitrol (0.25 micrograms)

“The health and safety of Arrey’s pharmacy customers has been put in danger as Arrey, through her pharmacies, dispensed misbranded and expired drugs,” FDA Special Agent Matthew Rosenberg wrote in a sworn statement.

For more on this story....

Keeping It Real Report reveals 700,000 Die Each Year from Counterfeit Drugs

Do you think that the counterfeit drugs issue is a small issue? Think again! In poorer countries they can account for as much as half of the supply chain and they claim an estimated 700,000 lives a year. In addition, their very use can undermine the effectiveness of the legitimate drug, thus adding research time and dollars to its list of victims.

A report issued this month from the International policy network gives a good overview of the problem of counterfeits in poorer nations. Below is a some highlights of an article by Franklin Cudjoe from IMANI Health on the report:

Counterfeit drugs kill over 700,000 people every year - new report

A new report from the International Policy Network and sponsored by IMANI Center for Policy & Education details the shocking burden of fake drugs in less developed countries. Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. That's equivalent to four fully laden jumbo jets crashing every day.

The report lays bare the ballooning problem of counterfeit and substandard drugs, which can constitute one third of the drug supply in certain African countries. These dodgy drugs result in unnecessary death and increased levels of drug resistance.

The report highlights more shocking evidence, such as:

• Nearly half the drugs sold in Ghana, Nigeria, Angola, Burundi, and the Congo are substandard

• About two thirds of artesunate (anti-malaria) drugs in Laos, Myanmar Cambodia and Vietnam contain insufficient active ingredient.

The entire article can be viewed at: www.modernghana.com

May 2009 report can be viewed at: www.africanliberty.org.

Vested Interests in Counterfeit Drugs

The following article by Bright Simmons appeared in Business Daily Africa and deals with the complicated politics of global anti-counterfeiting initiatives.

Apparently many countries are not convinced that a collaborative international initiative is advantageous for all in respect to global pharmaceutical supply chain security.

February 23, 2009:
Counterfeit drugs are flooding into Africa, where up to one in three medicines can be fake, causing widespread suffering and death.

The World Health Organisation wants an international agreement to tackle the threat but is being thwarted by members such as India and Brazil, more concerned with vested interests than African patients.

To fight counterfeits, the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) first needs to define them—but this new definition is opposed by an unholy coalition ranging from global anti-corporate activists to Indian and Brazilian pharmaceutical associations and heavily-lobbied governments.

They claim the definition would covertly introduce stricter patent protection and prevent generics manufacturers from exporting cheap drugs to Africa (generics are copies of drugs whose patents have expired, although some are in dispute). They accuse IMPACT of being a front for Western “Big Pharma.”

But IMPACT principally consists of and is led by national drug-regulatory authorities. Participation is open to every WHO member, so power lies mainly with developing countries that have negligible pharmaceutical sectors—and where counterfeit drugs are most common. A leading light in IMPACT has been Nigerian cabinet minister Dora Akunyili, the famous fighter against counterfeit drugs.

Moreover, there is no basis in the accusation that the new definition of “counterfeit” would stifle the trade of good quality generic medicines through tougher patent enforcement. The new definition states: “disputes concerning patents must not be confused with counterfeiting.”

This seems clear enough. If IMPACT threatens the global trade in quality generics, as its opponents claim, why do international generics associations support it?

In December the European Generic-medicines Association (EGA) welcomed the new definition, specifically because it “puts an end to any confusion with alleged patent infringement products which have nothing to do with counterfeiting.” The International Generic Pharmaceuticals Alliance was a founder of IMPACT.

Indeed its fundamental principles match those of reputable Indian organisations such as the Confederation of Indian Industry (CII): fakes and sub-standards have “tainted the image of many Indian brands,” it notes, “…placing patients’ health at risk.”

The Organisation for Economic Cooperation and Development (OECD) estimated last year that up to 75 per cent of the world’s counterfeit drugs come from India, most of which end up in Africa.

Strange alliance
But a strange alliance of anti-business activists and business associations purporting to represent India’s best interests has successfully lobbied the government to oppose IMPACT. The Indian Pharmaceutical Association says the counterfeit definition would harm the drug industry.

The SME Pharma Industries Confederation (SPIC), called “for safeguarding the export interests of the SME (small- and medium-sized enterprises) sector” by opposing it.

Indian delegates subsequently blocked IMPACT’s progress at the recent WHO Executive Board meeting and are threatening to prevent progress at May’s World Health Assembly (WHA): all the horse-trading will be done in coming months because WHA decisions are based on consensus.

But India’s own world-class and brand-conscious major producers stand to lose from India’s opposition to IMPACT. Fake versions of successful Indian generics have begun to flood the market, not least in India itself, losing them money, damaging their image and increasing disease.

Another fake argument is that “counterfeiting is an issue of trademark violation and has no bearing on public health,” to quote anti-patent campaigner KM Gopakumar of the Indian Centre for Trade and Development (CENTAD) think-tank.

IMPACT’s definition makes no specific mention of trademark violation but does of course outlaw “false representation” and “fake packaging”: if the packet is fake, do you really expect to find real medicine inside?Without trademark protection, manufacturers cannot protect against counterfeits.

Cheap drugs are a boon to health but they must be of a high standard, lest they do more harm than good. IMPACT cannot save Africa but nor does it set out to do so. It merely provides guidance to countries.

IMPACT’s definition can serve as a template for an African legislature tightening laws against counterfeiting--or improving trademark law to help genuine brands compete. African governments must not allow fake accusations to obstruct the campaign against fakes.

Simons is an executive of Ghana’s IMANI and is also involved in developing SMS verification for medicines.

Weekend News Highlights International Epidemic of Counterfeit Medications

XStream Systems found an op-ed article in the New York Times regarding the health epidemic in the third world regarding poor quality and counterfeit medications and a story reported by Bloomberg News about the seizure of millions in counterfeit malaria, HIV and tuberculosis drugs in SE Asia.

The phenomenon of counterfeit, adulterated and contaminated pharmaceuticals continues to grow and flourish as our global economy declines.

Until technology solutions such as XStream’s XT250 become ubiquitous, this malady will continue to proliferate and impact those beyond the third world.

Op-ed: More needs to be done to ensure safety, quality of drugs in the developing world.

In an op-ed in the New York Times (11/15, A21), Roger Bate, author, director of the health advocacy group Africa Fighting Malaria, and resident fellow at the American Enterprise Institute, wrote that, "if aid organizations are serious about combating the spread of deadly diseases in the developing world, they must do more to ensure the safety and quality of drugs."

According to Bate, the importations of counterfeit medicines "are only part of the problem." Bate explained that in order "deal with the scarcity of drugs, many poor governments have turned to local production." Still, "local producers often make low-quality" medicines. "Many poor countries," he wrote, "lack the regulatory structure needed to monitor safety and effectiveness. Some do not even have laws against selling substandard drugs, and none have sophisticated agencies like the" Food and Drug Administration (FDA).

Bate concluded that aid organizations must first "give technical and financial support to governments' sincere efforts to maintain strict drug inspection standards." Second, they should "always refuse to subsidize any low-quality drugs." And finally, organizations need to "insist that only brand-name and generic products approved by stringent drug agencies like the FDA be distributed."


Interpol seizes more than $6.65 million of counterfeit medicines in Southeast Asia.

Bloomberg News (11/17, Bennett) reports, "Interpol seized more than $6.65 million of counterfeit medicines against malaria, HIV, and tuberculosis in Southeast Asia and made 27 arrests, disrupting the region's fake drug trade for the second time in three years."

According to Aline Plancon, an officer involved in the "five-month investigation called Operation Storm," officials "seized more than 16 million pills, including fake antibiotics for pneumonia and child-related illnesses." Operation Storm "involved almost 200 raids" conducted across "Cambodia, China, Laos, Myanmar, Singapore, Thailand, and Vietnam."

Health officials were particularly concerned by "copies of a class of malaria drugs called artemisinins." Fake "artemisinin-based treatments containing small amounts of the medicine are helping the parasite responsible for malaria to evade authentic drugs in patients near Cambodia's border with Thailand, a recent study showed."

Largest European Seizure: Two Million Counterfeit Pills Seized in Brussels Airport

Two million counterfeit pills have been seized in Brussels Airport. The seizure of the drugs which originated in Mumbai, Indian and were bound for West Africa is the largest confiscation of counterfeit medicine in Europe.

The three Indian shipments contained counterfeit pharmaceuticals labeled as Tramal, a painkiller, and Fansidar, an anti-malaria drug.

Africa already has the daunting task of trying to control its malaria outbreaks without further obstacles of fake treatments. Many countries, organizations, and businesses have been aiding Africa to fight malaria and therefore, counterfeit medicine is a real threat to their work. In some countries up to 60% of anti-malaria drugs are fake and are aiding in the drugs resistance to current therapies.

Furthermore, the biggest victims are the children, because according to the Worlds Health Organization (WHO) a majority of malaria deaths are children under the age of five and Fasidar is one of the drugs given to pregnant women for the prevention of malaria.

The scope and intent of this particular case leads us to ask – Is any medication safe? How can we protect our most vulnerable medications? We believe the answer can be found in pharmaceutical authentication which verifies the drug itself. With nothing added and nothing destroyed; the method can be programmed to test various oral medications.

To learn more of this fascinating technology, see XStream Systems website at http://www.xstreamsystems.net/products.html.