Chinese Counterfeit Cancer Drugs Impact Consumers and Pharmaceutical Firms

While counterfeit pharmaceuticals have been prevalent in China for many years, China’s food and drug regulatory system has once again drawn attention to itself with the recent discovery that large amounts of fake anti-cancer drugs are flooding the market.

In an article written by Michelle Yu of the Epoch Times from June 22nd, Ms. Yu outlines yet another counterfeit drug scandal involving bogus cancer drugs that seem to permeate within China.

According to Ms. Yu’s Epoch Times article:

· Chinese authorities announced on June 12 that a Chinese-American person with a surname of Ding, along with three accomplices, had been arrested for manufacturing and selling fake anti-cancer drugs valued at US$4.4 million.

· Ding, 47, became an American citizen in 2003 after completing his postdoctoral studies abroad. He started selling counterfeit drugs in 2008, while serving as a general manager of a Hangzhou-based biopharmaceutical company.

· The counterfeits were sold through the Internet at one-tenth the price of the genuine products, which average around US$3,000 per bottle. The bogus anti-cancer drugs had been sold throughout at least eight provinces.

· The major counterfeited brands included Norvatis' leukemia drug Gleevec, Bayer's kidney cancer drug Nexavar, Astrazeneca's lung cancer drug Iressa, and Genentech's lung cancer drug Tarceva.

· There is speculation that Ding’s counterfeits account for only a small portion of the fake cancer drugs manufactured and sold in China and abroad.

· A spokeswoman for the Shanghai branch of the U.S.-based SciClone Pharmaceutical International drug company said that more than 20 percent of the company’s anti-cancer drug Thymosin Alpha-1 is counterfeit in the Chinese market, according to a May 26 report by China’s Southern Weekly. She added that counterfeits were found in government-owned drug stores.

Ms. Yu humanizes the scandal by telling the story of some of the victims of this counterfeit drug scandal:

· Among those that have been victimized by the counterfeits is Nanjing resident Geng, who spent thousands of dollars on Thymosin before realizing that the medication was having no effect. Geng purchased his medication from a state-certified drug store, Xinte.

· Tests conducted on the medication concluded the lot was counterfeit. Two members of Geng’s family who also took the counterfeit drug have since passed away.

· The same store’s stock supply of Alimta was also proven to be counterfeit by tests conducted by the brand’s manufacturer, Lilly LLC.

· Although pharmaceutical companies have reported these issues to China’s State Food and Drug Administration (SFDA), the agency has a history of being lenient on distributors of the fake drug products.

The Epoch Times story includes the deep seeded issue of official corruption that continues to feed these deadly criminal acts:

· The SciClone Pharmaceutical spokeswoman said she traveled to Nanjing for the Xinte drugstore case. The company issued a written testimony against the distributor of the bogus medication, but the local SFDA witnesses claimed that the samples collected from the drugstore were, in fact, authentic.

· Shortly afterward, the drugstore’s license—which had been revoked—was reinstated, after the wife of the former store owner registered for a new license and subsequently reopened the store. Her husband has not been indicted or punished.

· Eight different pharmaceutical companies, including SciClone Pharmaceutical and Lilly, have consulted with Nanjing SFDA officials and also reported the case to higher authorities.

· Former head of the SFDA Zheng Xiaoyu was executed in 2007 after being accused by the state of taking bribes to license bogus drugs.

· Chinese citizens have been quick to point the finger at the corruption and inertia of the drug regulatory authorities.

With a country’s regulatory agency either unable or unwilling to combat the deadly crime of counterfeiting drugs it is incumbent upon the industry’s supply chain to protect their individual brands, the supply chain as a whole and their consumer from nefarious entities bent on destroying lives and businesses for profit alone.

Secure Pharma Chain Blog endorses that individual members of the supply chain utilize technology to combat the criminal act of fraudulent, adulterated and counterfeit drugs, specifically solutions that allow the user to authenticate that the material that they have within their inventories is safe and efficacious for the consumer.

To read the entire Epoch Times article, visit:

http://www.theepochtimes.com/n2/content/view/37824/

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

Freightwatch International: Pharmaceutical Theft and Recovery

FreightWatch International an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released a pharmaceutical theft and recovery bulletin regarding a recent large pharmaceutical cargo theft.

The following is the entire FreightWatch bulletin:

A full truckload of pharmaceuticals was stolen in Glade Springs, Virginia, at approximately 9 pm the evening of Friday, June 25. The team drivers transporting the shipment left the load unattended while eating dinner inside a truck stop. The drivers returned to find the load missing.

Through an embedded tracking device, FreightWatch identified the load as being located at a truck stop in Bulls Gap, Tennessee, approximately 82 miles from Glade Springs, along I-81. At the same time, the proprietor of the truck stop where the load was found verified a trailer on the lot as fitting the description.

The trailer did not have a tractor attached, and the truck stop company parked an employee vehicle in front of the tractor until local police arrived.

Local police arrived on scene and recovered the load. Reports are the load was recovered intact. Details on this theft and recovery are still being developed and will be reported as they become available.

Secure Pharma Chain Blog endorses the use of sophisticated tracking devices be used in the transport of all pharmaceutical shipments to aid in the recovery of cargo thefts.

It remains unclear as to what will happen to these stolen goods because the chain of custody has been broken and their legitimacy is now in question. By using material authentication technology the cargo could be quickly verified as safe and efficacious inside their unit-of-sale containers without destroying or degrading the material.

To read the entire report from FreightWatch International, visit:

http://www.freightwatchintl.com/.

To learn more about material authentication solutions, visit: http://www.xstreamsystems.net/.

Pharmalot: Johnson & Johnson Was a Repeat Offender

Once again, Ed Silverman from the Pharma industry blog, Pharmalot seems to have the story on the continuing saga regarding Johnson & Johnson and the massive recalls from their McNeil Consumer Group.

In his blog Mr. Silverman provides some insight into some reports from CNN including video on their report.

According to Pharmalot:

· The recent rash of recalls, which has sullied the storied Johnson & Johnson image, actually reflects a series of production gaffes that go back several years, according to a report from CNN, which collected various FDA inspection reports by filing with Freedom of Information Act requests.
· The healthcare giant actually committed several violations that were detailed in inspection reports. Of course, companies with extensive manufacturing operations are likely to commit errors now and then, but the point CNN tries to make is that a pattern appears to exist.
· A December 2003 inspection report noted a mislabeling problem related to some lots of children’s soft-chew Tylenol; packages listed an incorrect amount of an ingredient per tablet. McNeil did not recall the affected products but destroyed and relabeled the products that had not yet been released into the market. In January 2006, FDA inspectors noted some equipment used to make drugs had not been properly cleaned. Another report from February 2008 listed insufficient follow-up and investigation of consumer complaints.

Clearly it would appear that there is a lot of past and present history that will be sorted out over the next several months as a variety of regulatory bodies, including Congress put Johnson & Johnson through their paces.

Secure Pharma Chain Blog, encourages everyone within the pharmaceutical supply chain, from manufacturer to dispenser, to deploy authentication technologies to protect their brand, inventories and the consumer from poor quality, fraud, adulteration and counterfeiting .

To read this excellent Pharmalot blog, visit: http://www.pharmalot.com/2010/06/johnson-johnson-was-a-repeat-offender/.

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

in-Pharma Technologist: Sanofi Works to Secure Egyptian Drug Supply Chain

French drug maker Sanofi-Aventis continues to spearhead the fight for a more secure pharmaceutical supply chain by launching an anti-counterfeit medication initiative in Egypt

Wai Lang Chu on June 23rd posted a story on in-Pharma Technologist about the mega Pharma manufacturer working within Egyptian authorities on addressing and countering the growing problem of drug manufacturing infiltration and drug counterfeiting in Egypt.

The following are some of the highlights of the posting:

· The move (by Sanofi) is the first of a three-phase initiative undertaken by the drug company and the Egyptian Ministry of Health to try to address and counter the growing problem of drug manufacturing infiltration and medicine counterfeiting in the country.
· Under the new project, Sanofi have worked alongside the country’s authorities providing them with guidance and training on the latest techniques in identifying counterfeit medication.
· Staff from Sanofi led an Egyptian delegation including officials from the Ministry of Health, the Customs Authority and the Ministry of Interior's Anti-smuggling Unit from the Ministry of Finance, to its Central Anti-Counterfeit Laboratory based in Tours, France.
· The delegation also visited the Customs Authority located in Le Havre to examine its anti-smuggling measures before visiting the French Ministry of Health.
· Over the last couple of years Sanofi have been making significant ground on tackling the problem of counterfeit drugs. Its Tours laboratories, opened in 2008, are the first of its kind and illustrate the measures pharma companies have to go to in order to secure it manufacturing and worldwide production capabilities.
· For example, Sanofi’s laboratories routinely conduct direct examinations of packaging items and leaflets as well as definitive chemical tests on suspect samples of commonly counterfeited products.
· Staff at the lab have developed test methods, distributing them globally in order to allow industrial plants to inspect and test, with the same criteria, the suspect products corresponding to those manufactured by Sanofi-Aventis.
· The drug firm have also introduced centralised ‘Identity Cards’ for the counterfeit drugs found, in a single, central data base, to make it possible to compare different types of counterfeit. · Sanofi’s collaboration with Egypt is part of efforts by its Government to tackle a problem that is picked up on globally and tarnishes the county’s reputation. Data from Business Monitor International (BMI) has identified Egypt as having made significant progress in tackling the counterfeit drug problem in the last two years.

Secure Pharma Chain Blog endorses the joint effort of industry and regulatory authorities working together to solve this insidious, deadly criminal act and encourages all members of the global pharmaceutical chain to work closely with government agencies in their anti-counterfeiting efforts.

The most effective processes to interdict fraud, adulteration and counterfeit medications includes a multi-layered approach of authentication technology solutions within the supply chain from production to dispensing.

It will take all members of the pharmaceutical supply chain, working together to solve this deadly crime to the consumer. No single link in the chain can effectively or successfully eradicate bogus drugs by itself.

To read the entire in-Pharma Technologist story, visit: http://www.in-pharmatechnologist.com/Industry-Drivers/Sanofi-works-to-secure-Egyptian-drug-supply-chain/?c=qendTuKNp6H%2BO0zFmrXycw%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily.

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

2010 Pain in the (Supply) Chain Survey: Product Security Continues to Be a Major Concern

Findings show the industry’s greatest pain points and reveal companies’ plans for the year ahead and beyond.

UPS, a leading provider of healthcare logistics and transportation services, launched its third annual “Pain in the (Supply) Chain” survey. The survey taken by healthcare supply chain executives, measures concerns about business and supply chain issues in the wake of healthcare reform and other industry changes.

The Survey was conducted by Harris Interactive on behalf of UPS and consisted of blind, in-depth telephone interviews with senior-level decision makers at nearly 150 pharmaceutical, biotech and medical/surgical device companies. All of the survey respondents were responsible for supply chain and logistics at their company.

The “Pain” study is an excellent resource as it relates to the most relevant trends and thoughts of the healthcare industry leadership.

The survey key findings are organized by nine key trend areas including Product Security concerns.

Regarding Product Security, the 2010 survey found the following:

• In the nine key trend areas, Product Security is tied with Access to Global or Emerging Markets.

• Product Security ranks as the third largest supply chain issue following Managing Costs and Regulatory Compliance.

• Product Security ranks as the second largest barrier to global expansion.

• 40% of industry respondents are highly concerned about product security, specifically their concerns are:

o 69% cite attempts to counterfeit products
o 60% name product theft as a top challenge
o 53% worry about product diversion
o 50% name theft in transit as a key challenge

The survey confirms the trend that industry leadership is beginning to understand the relevance of the criminal acts, namely theft, fraud, adulteration and counterfeiting impacting product security within the various healthcare supply chains.

Secure Pharma Chain Blog encourages both industry leadership and regulatory agencies to deploy advanced technologies and solutions to combat the various product security challenges cited in the survey.

To view the UPS survey, visit: http://www.ups.com/.

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

Reuters: World Customs Organization to Fight $200B Counterfeit Drug Industry

“Counterfeit drugs have become a $200-billion-a-year industry and the 176-nation World Customs Organization (WCO) will sign a declaration later this month to fight the scourge, an official said on Thursday.”

As reported by John Irish from Reuters on June 10th, the WCO announced their efforts to sign a document and unit behind international efforts to eradicate and fight counterfeit drugs.

The story is full of excellent facts, statistics and official quotes.

According to the Reuters story:

• "We have more fakes than real drugs in the market," said Christophe Zimmermann, the WCO's anti-counterfeiting and piracy coordinator. "In 2007-2008 alone, it rose 596 percent."

• The World Trade Organization says fake anti-malaria drugs kill 100,000 Africans a year and the black market deprives governments of 2.5-5 percent of their revenue.

• The Brussels-based WCO represents customs operations globally and has joined with former French president's Jacques Chirac's foundation to raise awareness at upper echelons to curtail the illicit industry.

• Spurred by Chirac's foundation, 176 national customs chiefs will sign a declaration on June 24 to ban the making and marketing of counterfeit drugs, Zimmermann told Reuters.

• Fake medicines often contain the wrong or toxic ingredients and pose a growing health threat worldwide, especially in poor countries where drugs are sold to treat conditions such as malaria, tuberculosis and HIV.

• "If these subjects are not dealt with and strong action not taken, they will be a source of conflict," said Catherine Joubert, director general of the Fondation Chirac, adding that so far 30 groups had signed the declaration.

• Getting the WCO's 176 members on board will lend legitimacy to proposals to revamp obsolete legislation and improve coordination between enforcement agencies, Zimmermann said.

Secure Pharma Chain Blog endorses the efforts of the WCO and other international agencies to fight this terrible criminal act that kills and impairs the health of millions globally each year.

Important to the success of the fight is the use of anti-counterfeiting technologies and authentication solutions designed to interdict bogus drugs within pharmaceutical supply chains to protect consumers.

To read Mr. Irish’s story in Reuters, visit: http://www.reuters.com/article/idUSTRE65961U20100610.

Or visit WCO's site at: http://www.wcoomd.org/.

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

MHRA Press Release: £150,000 Fake Drug Stash Seized in Sting Operation

MHRA, the United Kingdom’s agency responsible medicines and medical devices work, released a press announcement regarding a large seizure of counterfeit, unlicensed medicines and controlled drugs in London on June 9th.

The following is the Press Release from MHRA:

Counterfeit and unlicensed medicines, along with controlled drugs to the street value of approximately £150,000, were seized by the MHRA yesterday as part of a simultaneous raid on six locations across London, and two in Yorkshire with the assistance of local police.

Six people in the UK believed to be linked to a gang in Asia were arrested in connection with the illegal sale and supply of a range of medicinal products, most of which are suspected to be counterfeit.

Information was initially passed to the MHRA by pharmaceutical manufacturers Pfizer, Lilly and Sanofi-Aventis.

MHRA Head of Intelligence Nimo Ahmed said, “Large boxes containing counterfeit and unlicensed medicines together with packaging, computers and cash were seized and the suspect medicines will now be sent to government laboratories to assess their authenticity.

“The products seized relate to treatment for depression, erectile dysfunction, as well as painkillers, sedatives and injectable anabolic steroids.

“At this stage it is suspected that these medicines would have been supplied illegally over the internet.”

Mr. Ahmed said people should be vigilant when buying medicines online and should only do so from registered websites that clearly display a contact name, number, the logo from the Royal Pharmaceutical Society of Great Britain (RPSGB), and from premises that are registered with the RPSGB. Buying medicines from unregistered websites is dangerous as people would not know what they are actually taking. The dosages could be either too high or too low, or worse, the tablet could contain harmful ingredients.

“Better still, the safest way to obtain Prescription Only Medicines is from a ‘bricks and mortar’ pharmacy following a consultation with a GP or a healthcare professional,” he said.

“Those involved in this type of criminality do not care about your health. They are only in it for one reason, and that is to make money.”

The MHRA are grateful for the assistance provided by the Metropolitan Police, West Yorkshire Police, South Yorkshire Police and the pharmaceutical manufacturers in this case.

This seizure is an excellent example of the continued proliferation of counterfeit medications within developed countries and sophisticated pharmaceutical supply chains. Since 2006 the MHRA has seized more than £6 million worth of counterfeit medicines.

Secure Pharma Chain Blog endorses continued regulation and enforcement related to fraudulent, adulterated and counterfeit medications and encourages all within the supply chain, including regulatory agencies to deploy solutions and technologies to protect their inventories and consumers from the deadly effects of this criminal act.

To read the entire Press Release on the MHRA website, visit: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON084731.

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

Counterfeit Viagra Found in Australia’s Legitimate Supply Chain

In a June 21st press release Australia’s Therapeutic Goods Administration (TGA), the government agency tasked with protection the nation’s pharmaceutical and health care products announced the following:

The TGA is urgently investigating the source of the counterfeit Viagra (sildenafil) that has been supplied in Australia and has entered the wholesale/pharmacy supply chain.

The counterfeit product is labeled as 100 mg tablets in packs of 4 with Batch Number 314833021 and Expiry Date 04 2012.

To date there is no evidence that the product is harmful. The TGA has analysed a number of the counterfeit tablets and has found that sildenafil is present but not in the correct dose. However, because this batch has not been manufactured under controlled conditions it is not possible to extrapolate these test results to other samples of this batch. Therefore consumers in possession of Viagra tablets bearing this batch number and expiry date are advised not to take them but to return them to the pharmacy at which they were dispensed.

The details of the batch and expiry date for the product can be found embossed on the white left-hand panel of the carton flap.

No other batches of product have been implicated.

Pharmacies across Australia have been advised to quarantine stocks of this batch to prevent any further distribution.

This incident reiterates the need for supply chain authentication by all members of the pharmaceutical supply chain (production to dispenser) to eliminate the risks of consumers receiving fraudulent, adulterated or counterfeit medications.

Secure Pharma Chain Blog endorses the the deployment of a variety of solutions including authentication of drugs within their unit-of-sale container to verify the legitimacy and efficacy of the product to the consumer.

To read the press release, visit: http://www.tga.gov.au/alerts/medicines/viagra.htm.

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

FreightWatch International: May 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 May 2010.

FreightWatch recorded 63 cargo theft incidents in North America during May; a negligible increase from the 61 recorded in April. As is the most common M.O. in North America, slightly more than two-thirds of theft incidents reported to FreightWatch this month involved thieves commandeering stationary trailers with or without the paired tractor. Of the remaining third, three involved pilfering of trailers, two were driver-thefts, and fifteen lacked theft-type specification in their reports.

By commodity, pharmaceuticals experienced two incidents in May, one less than in April. However the May incidents were notable in that they happened in the same region/city and seemed to have been specifically targeted for their cargo.
The two pharmaceutical thefts in the report include:

• May 20th trailer theft of pharmaceutical products valued at $611,461. This theft has been reported in Secure Pharma Chain Blog on June 1st as being fifteen pallets of Lupin Pharmaceutical products.

• May 26th trailer theft of an unvalued amount of pharmaceutical products. This theft has been reported in Secure Pharma Chain Blog on June 14 as being several cases of products from Shionogi Pharmaceuticals.

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 supply chain security solutions, visit: http://www.xstreamsystems.net/.

Bloomberg: India May Send Officials to Inspect China Drug Units

In a story written by Thomas Abraham for Bloomberg News, India may be sending health officials to China to inspect manufacturing units of bulk drug suppliers to the South Asian nation.

The Press Trust of India is citing an un-named government official, that this action may be necessary to prevent cheap imports.

According to the Press Trust of India, “Indian Health officials want to verify drugs supplied to India are made at units certified by government agencies.”

To read the entire story, visit: http://www.bloomberg.com/apps/news?pid=20601091&sid=aC4k5.Pgfv.g.

This is an ironic twist given that both India and China’s pharmaceutical industries and supply chains have a notorious reputation around the globe.

Secure Pharma Chain Blog endorses any amount of increased regulatory scrutiny within either country to protect health care consumers around the globe.

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

Report: Drug Resistance Driven By Giving Underdeveloped Nations Access to Drugs

Drug-Resistant Diseases Driven By Non-Profits’ Giving Access to Drugs

The Center for Global Development (CDG), an independent, nonprofit group, has released a report about drug resistant diseases being driven by more access to drugs in underdeveloped nations.

In the report, the CDG states that the World Health Organization (WHO), governments and nonprofit groups are saving lives by distributing drugs to developing countries, but these groups are not paying enough attention to the dangers of drug-resistant diseases and may be contributing to endangering the lives they are meaning to save.

"Drug resistance is a natural occurrence, but careless practices in drug supply and use are hastening it unnecessarily," the CGD’s Rachel Nugent, who led the group writing the report, said in a public statement.

Millions of children in the developing world die every year from drug-resistant strains of malaria, tuberculosis, AIDS and other diseases. Strains of those diseases are increasingly resistant to antibiotics, and the world is losing its ability to treat these and more common diseases such as dysentery and respiratory infections.

The CGD's report urges the WHO to lead others, including pharmaceutical companies, governments, philanthropies that buy and distribute medicines, hospitals, healthcare providers, pharmacies and patients.

The report finds clear links between increased drug availability and resistance. For instance, in countries with the highest use of antibiotics, 75 to 90 percent of Streptococcus pneumoniae strains are drug-resistant, it found.

Poor quality drugs, counterfeit drugs, incomplete use of drugs and other factors all contribute to the problem, the report found. And this problem will worsen as drug access programs succeed, it cautions.

"The number of people being treated for HIV/AIDS, for example, increased 10-fold between 2002 and 2007; there was an 8-fold rise in deliveries of (drugs) for malaria treatment between 2005 and 2006, and the Stop TB Partnership's Global Drug Facility has expanded access to drugs for TB patients, offering nearly 14 million patient treatments in 93 countries since 2001," the report reads.

"While increased access to necessary drugs is clearly desirable, it brings challenges in preserving the efficacy of these drugs and ensuring they are used appropriately."

The CGD is recommending pharmaceutical companies, governments, donors, global health institutions, health providers, and patients to tackle this global health threat by implementing four key recommendations:

1. Collect and share drug resistance information across disease networks.
2. Secure the drug supply chain to ensure quality products and practices.
3. Strengthen national drug regulatory authorities in developing countries.
4. Catalyze research and innovation to speed the development of resistance-fighting technologies.

Secure Pharma Chain Blog endorses the concept by the CDG that an increased vigilance in securing the supply chain of these programs limits their vulnerability to fraud, adulteration and counterfeiting is one of the most significant steps in ensuring the efficacy of these efforts to fight these deadly diseases.

Unfortunately criminal elements are seizing on the opportunity of the tens of millions of dollars being poured into these programs to make huge profits while perpetuating and exacerbating the deadly effects of these horrible diseases.

Efforts and investment in solutions and technologies to protect the supply chain are necessary by every stakeholder of the supply chain to realize the goal of providing life saving medications.

Poor quality, fraudulent, adulterated and counterfeit drugs are causing millions to die each year from drug resistant strains of diseases that should be easily treated and contained. This epidemic is easily solved by more regulatory control and in the supply chains protecting themselves from criminal acts.

To read the entire CDG report, visit: http://www.cgdev.org/section/initiatives/_active/drugresistanceglobalhealth.

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

MedPage Today: FDA Warns Consumers About Fake Tamiflu

MedPage Today’s Cole Petrochko, writes about the FDA warning consumers on Friday about websites selling a fake "generic" version of the flu drug oseltamivir (Tamiflu), which may be dangerous to patients allergic to penicillin.

According to the FDA and MedPage Today:

· The Tamiflu fake does not contain the active ingredient of the drug it imitates but does contain cloxacillin, which can cause anaphylaxis in patients allergic to antibiotics in the same class as penicillin.

· The FDA uncovered the mimic through purchasing the drug from an online retailer claiming to be an out-of-business drugstore, which mailed the agency a package from India, the FDA said in a prepared statement.

· The drug came in two foil-backed blister packages labeled "Oseltamivir Phosphate 75 mg. Capsules TM-FLU" and containing 15 yellow and tan capsules each filled with white powder. The fraudulent pills are manufactured by TRYDRUGS Pharmaceuticals PVT. LTD. according to the sample blister pack, the agency said.

· The FDA cautioned that legitimate online pharmacies exist and that consumers can protect themselves against fraudulent and potentially dangerous drugs by looking for the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites (VIPPS) Seal.

Although this counterfeit retailer has been caught, the FDA is warning all that it is likely that other nefarious sources will attempt to sell this harmful counterfeit.

To date the FDA has not received any reports of consumers suffering from adverse effects of the fake. Anyone who has purchased a generic Tamiflu medication is encouraged to contact the FDA’s Office Of Criminal Investigations. If a consumer has taken the drug and is showing signs of adverse effects the should report them to the FDA’s MedWatch program.

To read the entire MedPage Today story, visit:

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/20741.

This is another significant chapter in the continued assult on global health care consumers by criminals selling dangerous counterfeit drugs.

Secure Pharma Chain Blog endorses and encourages consumers of only buying medications and health care products from legitimate, regulated and licensed pharmacies that utilize solutions and technologies which protects their inventories from fraudulent, adulterated and counterfeit medications.

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

Pharmalot: How Can J&J Recover From The Recall Scandal?

Once again Ed Silverman in his leading pharmaceutical insider blog Pharmalot continues to scoop the media with some of the most insightful perspectives on the recent Johnson & Johnson Recall Scandal.

In his latest Pharmalot blog piece, he interviews Laura Ries a Marketing Consultant for her take on how Johnson & Johnson handles their image in the midst of this continuing saga.

To view this excellent Pharmalot blog, visit:
http://www.pharmalot.com/2010/06/how-can-jj-recover-from-the-recall-scandal/#more-23772.

J&J Unit Recalls More OTC Drugs

Late Tuesday, Johnson & Johnson's McNeil Consumer Products division announced the inclusion of several other of its hugely popular brands to its massive OTC recall. It is now recall four lots of Benadryl allergy tablets and one specific lot of its Extra Strength Tylenol gel pills.

Including this recent recall announcement Johnson & Johnson’s McNeil Consumer Products division has issued four recalls over the past twelve months.

Various media outlets are reporting on this development:

The New York Times: "The Johnson & Johnson unit whose recall of liquid children's Tylenol and other pediatric medicines is under Congressional investigation said on Tuesday evening that it was recalling additional over-the-counter drugs." Specifically, McNeil Consumer Healthcare "said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills." According to a company statement, "'the products were inadvertently omitted' from an earlier recall -- one preceding the children's drug recall -- involving medicines made at a company plant in Puerto Rico." Although the drugmaker maintains that the chances of experiencing serious side effects are nil, it began recalling products from the Las Piedras plant in November after consumers were reportedly overcome by a mildew-like odor.

The Wall Street Journal: The smell purportedly prompted stomach pain, diarrhea, and nausea. The unit has since identified the manufacturing issue.

Bloomberg News: "the odor has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets."

Reuters: US House of Representatives Oversight and Government Reform Committee Chairman Edolphus Towns (D-NY) said, "This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson." He added, "I am troubled by what we have learned so far in our investigation, and this latest development adds to my concern."

The recent proliferation of recalls generated from pharma manufacturers due to poor quality production, inadequate quality control, cargo theft and various other adulterations to the consumer product strengthens the concept of material authentication by all members of the pharmaceutical supply chain. Material authentication, inside the products unit-of-sale container protects the members of the suppy chains inventories and the end use consumer.

To read the various reports on this recent announcement and the J&J recall from The New York Times, Wall Street Journal, Bloomberg News and Reuters, visit these sites:

http://www.nytimes.com/2010/06/16/health/16drug.html.

http://online.wsj.com/article/SB10001424052748704009804575309132577939048.html?mod=googlenews_wsj.

http://www.bloomberg.com/apps/news?pid=20601202&sid=awltXaS.MHl4.

http://www.reuters.com/article/idUSN159754220100615.

To learn more about pharmaceutical supply chain security solutions that protect the supply chain and consumers from poor quality, fraudulent, adulterated and counterfeit drugs, visit: http://www.xstreamsystems.net/.

AP: Chinese Drug Regulator Fired For Suspected Violations

The Associated Press is reporting that Zhang Jingli, the "deputy head of China's food and drug regulator, is being investigated and has been dismissed from his post, a state news agency said Sunday, citing an anti-corruption agency."

Xinhua, a state news agency, "cited the Communist Party of China Central Commission for Discipline Inspection, an anti-corruption body, in a brief report that offered no details on what the suspected violations were."

Highlights of the Associated Press story include:

· The move comes three years after the former chief of the drug agency was executed after a bribe-taking scandal in which several deaths were blamed on medicines the agency approved.

· Zhang Jingli, deputy director of the State Food and Drug Administration is under investigation for suspected "serious disciplinary violations," the official Xinhua News Agency said. The term is a standard party reference for graft and abuse of power.

· In 2007, Zheng Xiaoyu, the former head of the drug and food watchdog was executed after he was convicted of taking bribes to approve flawed medicine blamed for several deaths.

· Zheng was sentenced to death for taking bribes to approve an antibiotic blamed for at least 10 deaths and other substandard medicines.

· China said in April it would step up monitoring of a faulty rabies vaccine that was recalled last year but could have still been on the market. It was the latest in a series of quality problems in China in recent years, including tainted infant formula and other milk products that sickened children.

· China's pharmaceutical industry is lucrative but often poorly regulated. Local manufacturers and other players along the drug supply chain have been blamed in recent years for deaths linked to counterfeit or shoddy medications at home and abroad.

To read the entire Associated Press story: http://www.google.com/hostednews/ap/article/ALeqM5gHqNTMIPOepIIcWUsEuBqru23vrAD9GA86VG0

Given all of the issues with fraudulent, adulterated and counterfeit medications that have emanated from China internal regulatory scrutiny seems a very wise course of action.

Secure Pharma Chain Blog endorses all within the pharmaceutical supply chain to protect their receivables and inventories by deploying authentication technologies which allow for their validation within their unit-of-sale container.

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

DOJ/FBI: Georgia Man Pleads Guilty to Multi-Million-Dollar Cargo Theft Conspiracy

Goods Traced to More Than 20 Interstate Cargo Thefts Totaling More Than $3 Million Over Four-Year Period

In a June 2 Press Release, the Department of Justice and Federal Bureau of Investigation announced that a Georgia man, John Raymond Smith, has plead guilty in Atlanta Federal Court to conspiring to buy, receive and possess goods stolen from multiple interstate tractor trailer and container shipments throughout Georgia and the Southeastern United States from May 2005 and July 2009.

Mr. Smith also pleaded guilty to related cargo theft and money laundering charges.
The stolen goods included consumer goods, electronics, food and pharmaceuticals and many of the stolen shipments were bound for major retailers.

According to the Department of Justice Press Release:

· United States Attorney Sally Quillian Yates said of today’s plea, “Metro Atlanta is a major transportation hub, which makes it an attractive target for cargo thieves. By creating a market in this area for stolen goods, dealers like SMITH encourage others to steal interstate shipments, knowing that they will have a safe haven to unload and sell their truckloads of stolen goods. Consumers who buy these products should suspect they are stolen if they seem to be first-quality, name-brand products at unrealistically low prices.”

· IRS Criminal Investigation Special Agent In Charge Reginael D. McDaniel said, “Money laundering is not a victimless crime. This case is a prime example of how a criminal enterprise creates an underground, untaxed economy that harms our country's overall economic strength.”
· Georgia Bureau of Investigation Director Vernon Kennan said, “Cargo theft is an under-reported criminal phenomenon that has disastrous cascading economic consequences to Georgians. This annual estimated five billion dollar criminal activity negatively impacts transportation providers, retailers and consumers through higher shipping, insurance premiums and retail costs. These modern-day pirates cruise the nation's asphalt interstate corridors and parking lots, much like their predecessors who sailed the open seas for unsuspecting targets of opportunity. These pirates have been stopped.”

· According to United States Attorney Yates, the charges, and other information presented in court: Between May 2005 and July 2009, SMITH, who operated “Smith Sales Company” out of warehouses in Mableton and Hiram, Georgia, conspired with ROBIN L. CHEATWOOD, who operated “A-Z Discount” in Cedartown, Georgia, and other co-conspirators to buy, receive, and possess goods stolen from nearly two dozen interstate tractor trailer and container shipments valued at over $3 million throughout the Southeastern United States, including shipments stolen in Alabama, Georgia, South Carolina, and Tennessee. The tractor trailers and containers were stolen while parked at truck stops, motels, and container storage facilities, often at night. SMITH, CHEATWOOD, and others then sold the goods at discounted prices to consumers and wholesalers.

· As part of a plea agreement with the government, SMITH pleaded guilty to a three count Criminal Information filed on May 17, 2010, charging one count of conspiracy; one count of buying, receiving, and possessing goods stolen from an interstate cargo shipment; and one count of money laundering. He could receive a maximum sentence of up to 5 years in prison on the conspiracy count, 10 years in prison on each of the cargo theft and money laundering counts, and a fine of up to $250,000 on each count.

Mr. Smith’s sentencing is scheduled for August 17, 2010, at 9:30 a.m., before United States District Judge William S. Duffey, Jr.

This conspiracy of cargo theft underscores the vulnerability of the pharmaceutical supply chain and is evidence of how vulnerable the products that they consume daily are and the growing prevalence of adulterated, fraudulent and counterfeit medications.

Secure Pharma Chain Blog, endorses the concept of all members of the supply using authentication technologies to verify their inventories and chain of custody.

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

SecuringPharma: Another Pharma Cargo Theft in Memphis

Shionogi suffers cargo theft on the heels of the large theft of Lupin products in Tennessee.

According to SecuringPharma.com, Shinogi a Japanese pharmaceutical company with a US division was hit by cargo thieves towards the end of May.

As reported by SecuringPharma.com:

· The theft was of two cases of its OraPred a prednisolone product stolen from a trailer parked at a truck stop in Memphis, Tennessee.

· The Pharmaceutical Cargo Security Consortium said the small amount of material stolen could mean the incident was a 'probe' – in which thieves take a small amount of material to identify what pharmaceuticals are being distributed in the area.

· PCSC also notes the incident could be linked to the theft of two pharmaceutical shipments in the Memphis area earlier in May.

This theft underscores the vulnerability of the pharmaceutical supply chain and undermines the confidence of consumers.

Secure Pharma Chain Blog, endorses the concept of all members of the supply using authentication technologies to verify their inventories and chain of custody.

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

To read the entire SecuringPharma.com article, visit: http://www.securingpharma.com/40/articles/499.php.

Phamalot: Johnson & Johnson And Its Mystery Shoppers

Pharmalot, Ed Silverman’s excellent pharmaceutical insider blog posted a riveting blog on the continued saga of the truth behind Johnson & Johnson's recent recalls of its hugely popular over-the-counter brands which included Motrin and Tylenol.

Currently the industry giant finds itself in embroiled in Congressional investigations and regulatory review from the FDA which may involve criminal charges.

Here are some of the highlights from the Pharmalot blog:

· The Johnson & Johnson recall scandal is threatening to envelope the healthcare giant in ways that, just a few months ago, no one could imagine. The latest twist involves a series of emails that appear to lend further credence to what a Congressional committee is calling a ‘phantom recall,’ which was allegedly undertaken to obscure serious problems with widely used over-the-counter pediatric medications. The episode is part of a long-running chain of events may prompt the FDA to consider criminal charges.

· At issue are quality-control failures that forced J&J to recently recall tens of millions of bottles of such venerable brands as Tylenol and Motrin, among others, which had been found to contain too much active ingredient or metallic specks. But instead of issuing a recall, J&J hired an outside contractor to buy Motrin from stores, and its employees were instructed to act like “regular customers” and not discuss a possible recall. This was disclosed at a May 27 Congressional hearing.

· Since then, internal J&J documents obtained by Pharmalot would appear to undercut some of J&J’s contentions, such as the notion that its contractor’s assignment was limited and transparent. A J&J spokeswoman told The New York Times the contractor’s memo was created without the knowledge of its McNeil Consumer Healthcare unit. But e-mails suggest J&J employees were aware, including Lily Vandermolen, an associate product director at McNeil, and Carolyn Parziale, a diretor of quality assurance at McNeil.

Mr. Silverman’s blog goes into detail about Johnson & Johnson’s insider knowledge and it would surely mean that there are many documents that leave a trail to an institutional knowledge of the product out in the supply chain was well known to have quality issues and be potentially harmful to the consumer.

Secure Pharma Chain Blog endorses that all members of the pharmaceutical supply chain deploy technologies and solutions to actively verify the authenticity and quality of its inventories to protect themselves and the consumers from poor quality control, adulteration, fraud and counterfeit product.

To learn more about authentication technologies that can verify pharmaceutical products inside their sealed unit-of-sale container, visit: http://www.xstreamsystems.net/.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/06/johnson-johnson-and-its-mystery-shoppers/#more-23843.

The Genuine Danger of Counterfeit Medicines

This European Federation of Pharmaceutical Industries and Associations (EFPIA) YouTube video from 2008 details the dangers and prevalence of fraudulent, adulterated and counterfeit medications in developed and non-developed countries around the globe.

The data and information in this story is still particularly relevant given that this dangerous criminal act has grown in size and scope since this piece was first produced.

Secure Pharma Chain Blog, endorses the use by all members of the global pharmaceutical supply chain to deploy technologies and solutions to protect their inventories and the health care consumer.

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

PSI Statistics on Pharmaceutical Counterfeits Cited on SafeMeds

The Pharmaceutical Security Institute (PSI), a pharmaceutical manufacturer organization that tracks and investigates counterfeit drugs globally, recently released updated survey finding statistics on SafeMedicines.org regarding drug counterfeiting.

According to the PSI data, drug counterfeiting has increased by 9.2 percent worldwide over the past year.

Other key survey findings include:

· Variety of Pharmaceutical Products Increasing: There were 808 types of counterfeit pharmaceutical products identified in 2009, up more than 36 percent from 2008.

· Geographical Locations More Diverse: Counterfeits were detected in 118 countries in 2008.

· Counterfeit Drugs Going Wholesale: In 531 incidents, counterfeit products reached licensed wholesale distributors and/or pharmacies in 48 different countries. 472 of the 978 counterfeit medicine seizures made by law enforcement were of "commercial" size.

To read the entire Safe Medicines.org posting, visit: http://www.safemedicines.org/2010/06/partnership-for-safe-medicines-psm-joins-with-irish-patients-association-to-combat-counterfeit-medicine-threat.html

The prevalence of this deadly criminal act continues to grow globally within developed and non-developed countries and impacting the health and well being of hundreds of millions of healthcare consumers.

Secure Pharma Chain Blog endorses global regulatory agencies and the members of the various pharmaceutical supply chains to deploy technologies to interdict nefarious product and to verify the authenticity of their inventories.

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

Fake Drugs are a Real Menace

Quality and safety concerns hurt India’s pharmaceutical promise. A new report studies the extent of such worries.

Nick Schulz, Editor of American.com and a fellow at the American Enterprise Institute writes an interesting piece which was posted June 3rd on Livemint.com regarding the Indian Pharmaceutical industry and its largest obstacle in its rise to become a true pharmaceutical power-“concern over the quality and safety of its pharmaceutical supply chain.”

Mr. Schulz states, “if India can overcome these concerns—something a report published on 18 May indicates is possible—the sky is the limit for Indian firms to push the technological frontier in this critical industry.”

Some of the highlights from Mr. Schulz:

· Concerns about fake and substandard drugs have led to multiple actions by governments around the world to hinder trade in Indian medicines. In 2008, the European Union detained Indian drugs citing concerns over counterfeiting and fakes. Governments from Sri Lanka to Nigeria have also blocked some Indian drugs from entering the market. Drug industry officials from Japan to the US have also fingered fakes as a chief obstacle to a more robust Indian drug industry.

· The Indian government has pushed back against this common perception, releasing a report late last year claiming that the vast majority of drugs produced in India were of high quality. But that government-sponsored report was likely far too optimistic. Its underlying data and methodology have not been made available to the public, and its findings flew in the face of anecdotal and other evidence that India’s problem with quality is genuine.

The article also reports on a recent study co-sponsored by the London-based Legatum Institute and the New Delhi-based Liberty Institute, A Safe Medicines Chest for the World: Preventing Substandard Products from Tainting India’s Pharmaceuticals.

· In Delhi, 80% of the sampled pharmacies were providing at least some substandard medicines (ranging from drugs with zero-active ingredient to those with chalk or talcum powder substituting for active ingredient). In Chennai, almost 40% of the surveyed pharmacies were found to have sold some below-standard products.

· Meanwhile, 7% of the samples from wholesale traders that the researchers investigated were found to be of poor quality. This is encouraging, in that it is a small enough percentage that one can imagine a concerted effort tackling this problem. But since wholesalers sell across the market, it means just a few bad actors can have widespread impact.

· Almost three quarters of the pharmacists surveyed admitted there was a problem with substandard medicines and said they knew of pharmacists who were complicit in the sale of substandard drugs. Perhaps most worrisome, over 90% of respondents said they had been approached by a wholesale trader offering to sell them substandard pharmaceuticals at a discount. Most of the pharmacists claimed that government corruption and bribery were problems in maintaining high standards. And almost 25% of the pharmacists reported that government officials had demanded bribes of them.

Mr. Schulz explores some of the necessary measures that the Indian Government and the Indian Pharmaceutical Industry need to do to improve their quality, protect the pharmaceutical supply chain, improve their commercial reputation and protect consumer’s world wide.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain world wide to protect themselves from fraudulent, adulterated and counterfeit medications by deploying solutions that authenticate and verify the inventories.

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

To view the report on livemint.com, visit: http://www.livemint.com/2010/06/03210904/Fake-drugs-are-a-real-menace.html.

Forbes: The World's Biggest Illicit Industries

Nathan Vardi reports in a June 4th edition of Forbes.com on the World’s Biggest Illicit Industries.

According to Forbes.com the seven illicit industries are:

· Counterfeiting
· Illicit Drugs
· Cargo Theft
· Cigarettes
· Oil Smuggling
· Human Trafficking
· Art Theft

Mr. Vardi states, “from drugs to oil smuggling, the dark side of globalization generates hundreds of billions in profits annually.”

Of the seven primary illicit industries, three of these (counterfeiting, illicit drugs and cargo theft) significantly impact the health care of consumers via fraudulent, adulterated and counterfeit drugs within the legitimate pharmaceutical supply chains globally.

Here are some of the highlights from Mr. Vardi’s piece:

· “But it's not the only criminal enterprise raking in billions of dollars a year. The world's biggest illicit industries continue to grow by circumventing national laws and regulations, and taking advantage of new international networks and technologies. This dark side of globalization has generated huge profits and political instability. The exact size of these industries can be estimated only vaguely, but their scope and impact cannot be denied.”

· Counterfeiting - The Organization for Economic Cooperation and Development in 2009 said the international trade in counterfeit and pirated goods increased to more than U.S. $250 billion, almost 2% of world trade, up from US$200 billion in 2007. The world is awash in fakes--from trademarks like Nike to copyrighted music and high-tech invention like pharmaceuticals or computer chips. The World Customs Organization guesses that counterfeiting accounts for 5% to 7% of global merchandise trade.

· Cargo Theft - Cargo theft is as much as a $30 billion problem annually, according the Federal Bureau of Investigation, which points out it can include anything moved by truck or plane--tailored suits, frozen shrimp, computer chips, toilet paper. These are often non-violent thefts of goods in transit, but they can include sophisticated methods that often involve surveillance. The U.S., Mexico, Brazil, South Africa, Russia, India and the U.K. are the countries most at risk for cargo theft globally, according to FreightWatch International.

· Still, while the size and reach of global illicit industries can seem overwhelming, there are signs of hope. Law enforcement groups from around the world are learning to cooperate in the battle against international crime. Just this week seven people were arrested in Liberia in connection with a conspiracy to distribute more than $100 million of South American cocaine in Europe after the son of the president of Liberia worked undercover with U.S. drug agents.

Secure Pharm Chain Blog has reported extensively on the growing threat of these illicit industries and the impact that it has on the health and welfare of consumers througout the globe.

Secure Pharma Chain Blog, endorses increased cooperation between countries through enhanced enforcement and in the various global supply chains (specifically pharmaceuticals) incorporating various technologies to protect their inventories and consumers from fraudulent, adulterated and counterfeit medications.

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

To read the entire Forbes.com article, visit:
http://www.forbes.com/2010/06/04/biggest-illegal-businesses-business-crime.html

Health Canada Provides Counterfeit Health Products Guidance

Health Canada, the official Canadian governmental regulatory agency charged with the responsibility of the countries public health, has released a guidelines document on the public health issue of the counterfeiting of health products and outlines how the agency intends to identify and manage health risks associated with fakes.

According to Diana Dowhwaithe, Health Canada’s Director General the document is meant "to manage the risk to Canadians and to have the counterfeit product removed from market using the most appropriate level of intervention and notifying parties at risk."

The purpose of the new guidelines document is to help Health Canada's inspectorate and enforcement officials focus on potential vulnerabilities in health product "manufacturing, packaging/labelling, wholesaling, importation, distribution, sale and use."

The scope of the guidance covers finished medicinal products, raw materials and ingredients used in their manufacture and primary and secondary packaging, as well as advertising materials used to promote products.

It also lays out a detailed definition for counterfeiting, noting that - in general - the term does not cover: diverted products (although these could serve as an indicator of counterfeit distribution); products using patented ingredients/design but which do not mislead or claim to originate from the rights holder; and products which do not disclose all ingredients or have labelling issues.

The document defines counterfeit medical products as:

"A counterfeit health product is one that is represented as, and likely to be mistaken for, an authentic product. Counterfeiting can apply to both branded and generic products, and could relate to a product’s identity or source, could include products with the correct ingredients/components, with the wrong ingredient/components, without active ingredients, with insufficient active ingredients or with misleading packaging or labelling."

The lone point of contention of the document by Secure Pharma Chain Blog's perspective is the report's minimizing of the potential risk to the Canadian population of counterfeit health care products, which runs counter to most relevant statistics, trends and generally acceptated authorities opinion's of the growing nature of this potentially deadly threat.

Secure Pharma Chain Blog endorses the continued enforcement, guidance and improved focus of all regulatory agencies in dealing with fraudulent, adulterated and counterfeit medications and medical products and encourages all members of the pharmaceutical supply chains to utilize solutions and technologies to protect their inventories and healthcare consumers.

To learn about supply chain solutions to pharmaceutical counterfeiting, visit: www.xstreamsystems.net.

To read the entire document from Health Canada, visit:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/activit/pol_0048_counterfeit-contrefacon_eng.pdf.

Dubai Seizes 7 million Counterfeit Pills in a Private Company Warehouse

Zawya.com reports about a press conference held on May 31st by Dubai Customs announcing a seizure of a large amount of counterfeit medicine in a warehouse of a registered local company at the Dry Port in Dubai.

The seizure of 7 million counterfeit pills of different medication is considered one of the largest seizures in the region.

According to Zawya.com:

· H.E. Ahmed Butti Ahmed, Executive Chairman of Ports, Customs and Free Zone Corporation and Dubai Customs Director General issued a statement during a media conference.

· H.E. Ahmed Butti Ahmed clarified in the statement that the seized medicine is locally prohibited as approved by the tests conducted on its samples and is of counterfeited sexual supplements which bear trademarks of international companies.

· The case is considered an infringement of legal protection of the companies owning such trademarks and a clear violation of the UAE health legislations which prevents selling this medicine unless a medical prescription is issued by a licensed human doctor- as per the ministerial decisions issued under the law of pharmacy profession and pharmaceutical institutions.

· H.E. Ahmed Butti Ahmed said that the investigations conducted by Dubai Customs revealed that an employee working in the implicated company stored the medicine after receiving it from an Arab trader. He kept the haul on a quay at the Dry Port Customs Centre which belongs to the referred company, without notifying the manager of the company who was outside the UAE, in exchange of AED 3000 a month.

· H.E. Dubai Customs Director General expressed his appreciation to the Customs Intelligence employees for the proper handling of the information they received about this counterfeited medicine which played a major role in seizing it. He also praised Customs inspectors for their vigilance as they work night and day to secure the country and the great role of the IPR Department at Dubai Customs in this regard.

To read the entire story on Zawya.com, visit:

http://www.zawya.com/story.cfm/sidZAWYA20100531105654/Dubai%20Customs%20seizes%207%20million%20counterfeit%20pills%20in%20a%20private%20company%20warehouse%20in%20Dry%20Port.

This large seizure shows the vulnerability of the international pharmaceutical supply chain and the various nefarious entities that are impacted by this criminal act.

Secure Pharma Chain Blog endorses that all members of the pharmaceutical supply chain use of authentication technologies to protect and verify their inventories and protect health care consumers.

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

Health Day: Dangers Lurk in Impotence Drugs Sold on Web

"Study finds many contain toxins, or too much/too little of the active ingredient."

Amanda Gardner in Health Day reports on a new South Korean study warning of the dangers of buying erectile dysfunction drugs over the internet.

The new study, which was conducted in South Korea and is being presented at the American Urological Association annual meeting in San Francisco, “finds that not only can these knock-off drugs be contaminated, they may contain too much of the active ingredient or none at all. The drugs could especially be dangerous for men with hypertension or heart disease, the study found.”

The following are the highlights from Ms. Gardner’s story:

· "There are lots of rip-offs," said Dr. John Morley, director of geriatrics and acting director of endocrinology at Saint Louis University. "There's still a lot of evidence that many of the things you buy off the Internet without going through a regular pharmacy might appear cheaper or better but they're usually not and they usually don't work."

· "Men who have sexual dysfunction are prepared to try anything and they do try a large number of bizarre things," said Morley. "They try all the Viagra look-alikes, so people are going to buy them."

· In the study, the South Korean team compared 19 counterfeit erectile dysfunction (ED) drugs against prescription Viagra, obtained directly from Pfizer Pharmaceuticals, and Cialis, provided by Lilly.

· About one-third of the counterfeit pills actually differed in size from the real thing, while 42 percent differed in color.

· Fifty-eight percent had too much active ingredient, sometimes as much as 2.4 times more, while 3 percent had no active ingredient at all.

· Some contained unapproved compounds intended to promote an erection.

· Only one of the counterfeit drugs contained "proper active ingredients," the researchers stated. Some contained potential toxins, including mercury and lead.

· Even genuine Viagra has risks, experts note, especially for men who take nitrates for chest pain. And there could be drug interactions with both real and fake ED drugs.

· "All these drugs have side effects and that's probably the big reason why patients should be getting them through a physician," Morley said. "While these things may be cheaper, they potentially have much greater side effects."

The study reinforces the deadly issue of fraudulent, adulterated and counterfeit medications which seem to proliferate on the internet and ultimately lead to the contamination of the legitimate pharmaceutical supply chain.

Secure Pharma Chain Blog, recommends that all members of the pharmaceutical supply chain use a variety of technologies and solutions to protect their inventories from fraudulent medications.

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

Read the entire Health Day article, visit: http://healthday.com/Article.asp?AID=639623.

Dr. Weil: Bogus Drugs Online

The following blog, from Dr. Weil’s Daily Blog, Your Health Today, appeared online on Wednesday, March 24, 2010.

Andrew Weil, M.D., is a world-renowned leader and pioneer in the field of integrative medicine, a healing oriented approach to health care which encompasses body, mind, and spirit. In this particular blog, Dr. Weil takes on the deadly issue of fraudulent, adulterated and counterfeit drugs:

The worldwide market for counterfeit drugs sold online is projected to reach $75 billion this year, a 92 percent increase over the past five years. The biggest sellers: fake drugs for erectile dysfunction (ED), which are especially popular because many men are embarrassed to discuss sexual problems with their physicians and because the genuine pharmaceuticals are costly. A study published online in January, 2010, by the International Journal of Clinical Practice estimated that as many 2.5 million men in the European Union alone may be using counterfeit Viagra, some of which can be harmful, even deadly. The researchers found that 150 patients had been admitted to hospitals in Singapore and four died after taking fake Cialis and herbal preparations sold as ED cures. The "Cialis" contained a powerful drug for diabetes.

Fake ED drugs aren't the only problems: in Argentina two pregnant women died after injections of a counterfeit treatment for anemia; in Bangladesh, 51 children died of kidney failure after taking paracetamol (acetaminophen) contaminated with anti-freeze. Some fake Viagra contained amphetamine or caffeine and bulk lactose or was colored blue with printer ink. A "vaccine" for life-threatening meningitis was found to be only water. Other fakes included antibiotics, contraceptives and anti-malarial pills.

My take? Aside from this additional evidence of over-reliance on drugs to solve real or perceived health problems, this is a disturbing trend. Not only does it pose the threat of ingesting harmful ingredients, but presents the danger that by circumventing your physician to buy drugs you think you need, any underlying, undiagnosed medical problem you may have would be missed, potentially putting you at additional risk.

To view Dr. Weil’s blog, visit: http://www.drweilblog.com/home/2010/3/24/bogus-drugs-online.html.

Advertising Age: Combating Counterfeit Drugs

“In the U.K., a Rat Makes a Graphic Point”

In an article, which appeared in July, 2009, Advertising Age published a story about Big Pharma using mass media and advertising to draw public awareness to the deadly issue of counterfeit drugs.

Specifically, it discusses Pfizer and its adverstising agency, Universal McCann’s shocking campaign to lead the fight against the availbility of counterfeit drugs on the internet.

The following are some of the highlights from the piece:

· Counterfeit drugs not only cost drug companies a lot of money each year but also can cause long-term side effects or in some cases death. Drug company Pfizer and its agency, Universal McCann, decided to take the lead in fighting against the availability of counterfeit drugs on the internet and shock people into taking the problem more seriously.

· A multiplatform campaign ran in the U.K. with the central image of a rat coming out of a person's mouth. The "regurgitated rat" campaign was rolled out across TV, cinema and print. In order to reach those most likely to be purchasing counterfeit drugs, the online community, Pfizer redirected users searching under health and medical terms to a website that offered more information.

Secure Pharma Chain Blog, endorses the concept of using all mass media outlets to raise awareness of this deadly crime within the general public and all health care consumers.

To read the entire story in Advertising Age, visit: http://adage.com/mediaworks/article?article_id=137812.

Reuters: Counterfeit Drugs on Rise, Pose Global Threat

“Unwary consumers buying counterfeit drugs on Internet.”

On May 19th, Reuters posted a story written by Stephanie Nebehay regarding the recent World Health Organization meeting in Geneva, Switzerland.

The article encapsulates the proliferation of this deadly crime and the difficulty in countries around the globe in developing a comprehensive strategy in dealing with it. Although many nations realize the deadly consequences, there are many commercial interests including generics and intellectual properly rights which are complicating efforts to fight this illicit activity on a global scale.

The following are some of the highlights from Ms. Nebehay’s report:

· Production and sale of counterfeit drugs is on the rise in rich and poor countries, with more unwary consumers buying them over the Internet, experts warned on Wednesday.

· Fake or substandard versions of medicines are often hidden in cargos taking circuitous routes to mask their country of origin as part of criminal activity worth billions, they add.

· "They put people at risk of harm from medical products that may contain too much, too little, or the wrong active ingredient and/or contain toxic ingredients," said Margaret Hamburg, head of the U.S. Food and Drug Administration (FDA). "Counterfeiting is growing in complexity, scale and geographic scope," she said in a speech to the annual ministerial meeting of the World Health Organization (WHO).

· In wealthy countries, counterfeiting often involves "expensive hormones, steroids and anti-cancer medicines and pharmaceuticals related to lifestyle," a WHO report said.

· But in developing countries, especially Africa, counterfeit medicines are commonly available to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS, it said.

· Margaret Chan, WHO director-general, said that illicit products had also increased the problem of drug resistance, including to vital anti-malarials and HIV/AIDS drugs. "For a patient, any medicine with compromised safety, efficacy or quality is dangerous," she said.

· Major generic drug makers in India and Brazil, backed by health activists, charge that concerns about counterfeit drugs are being hijacked by pharmaceutical companies keen to protect their patents against legitimate generic competitors.

· (Margaret) Chan said that her United Nations agency would not be drawn into policing intellectual property (IP). "The role of the WHO should be concentrating on public health, not on law enforcement nor intellectual property enforcement."

· There were 1,693 known incidents of counterfeit medicines last year, a rise of 7 percent

Drug counterfeiting is a widely growing, deadly illicit act that is impact millions each year while most of the world’s population remains ignorant of the dangers that they face daily as they consume medications.

Secure Pharma Chain Blog, encourages the pharmaceutical supply chain in advance of regulatory mandates to deploy technology and solutions to protect their inventories and the consumer from this deadly criminal deed.

It is incumbent upon industry to lead the way to supply chain safety and protect their businesses and consumers.

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

To read the entire Reuters article, visit: http://www.reuters.com/article/idUSLDE64I26E20100519.