Lack of Authentication 'Undermines US Anti-Counterfeit Strategy'

Phil Taylor in SecuringPharma reports on the International Authentication Association's critical stance of a recently published plan by the Obama Administration's US Joint Strategic Plan on IP Enforcement.

In this excellent July 30th SecuringPharma post, Mr. Taylor reports on the International Authentication Association (IAA) take on the US governments plan:

• US policymakers have "missed a golden opportunity" to make authentication technologies mandatory for intellectual property protection and protection against counterfeits, according to the International Authentication Association (IAA).

• Referring to the USA's recently-published Joint Strategic Plan on IP Enforcement document, the IAA says that it is "disappointed to see the only reference to authentication methods is the proposal to establish a mandatory requirement for a track and trace system for pharmaceuticals and medical products."

• The strategic plan was drawn up by the USA's IP Enforcement Coordinator (IPEC) and sets out a series of measures to tackle the trade in counterfeit and pirated products, including pharmaceuticals, both domestically and internationally.

• "The plan does not go far enough and should have been stronger in endorsing the use of authentication technologies and methods - not just track and trace - for IP protection," said the organisation in a statement.

• Track and trace can help to secure the supply chain from the infiltration of counterfeiting but it cannot in itself identify nor confirm whether products distributed beyond legitimate supply chains are genuine or not, it pointed out.

• "The national plan to fight counterfeiting should include references and guidance on the means of authentication, because detecting fakes is a key part of any anti-counterfeiting strategy," said Jim Rittenburg, the IAA's chairman.

• He pointed out that the International Organisation for Standardisation (ISO) has been developing performance criteria for authentication tools used in anti-counterfeiting, and has said that "...track and trace technology when used alone is not considered to be an authentication solution."

• "We would like to see the IP Enforcement Coordinator look at the broader role of authentication technologies and programs for the next strategic plan," said Rittenburg.

Secure Pharma Chain agrees and endorses IAA’s criticism of the recently published plan and its lack of authentication as a proposed standard and strategy. The Joint Strategic Plan missed an opportunity to provide global leadership, regualtory guidance and protect industry and consumers from dangerous and potentially deadly criminal activity.

Authentication of the products is the critical component of enforcing intellectual property and protecting supply chains and consumers from fraudulent, adulterated and counterfeit products.

While track and trace solutions are important in understanding the transactional process, it does not protect the consumer from fraudulent product.

All of the most recent counterfeit and fraudulent medication incidents that have resulted in death or significant health care issues with consumers have the appropriate track and trace pedigrees and would likely have been interdicted had their been an authentication process in place.

To read the entire SecuringPharma story, visit: http://www.securingpharma.com/40/articles/537.php.

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

Stolen in 2009, GSK Inhalers Showing Up in Pharmaceutical Supply Chain

The FDA and GlaxoSmithKline have recently announced that some of the Advair Diskus inhalers stolen from a GSK distribution warehouse in 2009 have been found in some pharmacies.

According to the GSK press release:

• The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

• The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and GSK continues to work with the FDA to aggressively investigate the matter.

• Medicine in the stolen cartons could represent a health risk because it has been removed from the legitimate supply chain. The product may have been tampered with and the storage conditions under which the stolen products were held are unknown. Inhalers from these lots should not be dispensed, sold, or used.

• The lot numbers, doses, and expiration dates of the stolen Advair Diskus inhalers are:
Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose – Exp: Sep 2010
Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose – Exp: Sep 2010


The discovery of the stolen products within the legitimate supply chain magnifies the commercial gaps that exist within the legitimate pharmaceutical supply chain and the ability for those with a nefarious intent to exploit them.

As Secure Pharma Chain continues to report, there is a vast network of criminal elements that are taking advantage of the huge profits in dealing with stolen, sub-standard, adulterated, fraudulent and counterfeit medications. This criminal element imperils the legitimate industry and victimizes the consumer, sometimes with deadly consequence.


In this particular incident, the danger to the consumer is the efficacy of the drug and the unknown as to the conditions that it has been stored and if it has been somehow altered, diluted, adulterated or the contents counterfeited by the criminal element which could harm the end use consumer.

Secure Pharma Chain endorses that all members of the legitimate supply chain deploy a variety of solutions and technologies to close these commercial gaps, protect their inventories and make certain that the products that they are passing onto the consumer are safe and efficacious.


To learn more about pharmaceutical supply chain solutions, designed to protect and authenticate materials, visit: http://www.xstreamsystems.net/.

SecuringPharma: Medicine Seizures by EU Customs Rise Again in 2009

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

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

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

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

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

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

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

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

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

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

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

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

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

Dallas Morning News: Investigation Reveals That Chinese Government "Hampered" FDA Probe of Tainted Heparin

In a follow up to a previous posting on a July 23rd posting of a Pharmalot.com blog, The Dallas Morning News in its Trail Blazers Blog continues the reporting on Congress questioning the FDA on their ability to work with the FDA on the Tainted Heparin probe.

According to the Dallas Morning News Trailblazer Blog:

"An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had 'severely hampered' a Food and Drug Administration probe into contaminated heparin." They wrote to FDA commissioner Dr. Margaret Hamburg, saying that "FDA officials informed them in June that the agency was 'denied full access to manufacturing and laboratory facilities,' nor were they allowed to review records." Notably, the "FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008."

The continued exposure of the lack of Chinese cooperation reveals to everyone within the pharmaceutical supply chain that there are many significant gaps in the ability of regulatory authorities to control and enforce the quality of medications that are now such a prevalent part of the pharmaceutical supply chain.

Secure Pharma Chain encourages industry supply chain leaders to take appropriate measures and deploy technologies that protect their brand, secure their inventories, differentiate themselves in the marketplace and most importantly save from harm consumers who take these medications.

To view the Dallas Morning News blog, visit: http://www.trailblazersblog.dallasnews.com/.

Pharmaceutical Cargo Theft and Recovery

FreightWatch International via a cargo theft update, reports on a July 16th pharmaceutical cargo theft in Jefferson, Ohio.

According to the FreightWatch report, a full truckload of pharmaceuticals was stolen from a truck stop in Jefferson, Ohio, at approximately 4 p.m. Central on Friday, July 16. The solo operator entered the truck stop and found the tractor-trailer missing upon return.

The FreightWatch Emergency Response Center (ERC) was notified, and through an embedded tracking device, the load was located.

FreightWatch coordinated a multi-jurisdictional response as the load remained in-transit, resulting in a full recovery and arrest of the suspect.

The load was subsequently returned to the transportation provider for an on-time delivery.

Secure Pharma Chain is encouraged by the use of technology to aid in the interdiction of pharmaceutical cargo theft and to minimize the negative impact to the supply chain and consumers.

It remains apparent that criminal elements realize the huge profits of pharmaceutical theft and are targeting these products.

Secure Pharma Chain endorses all members of the pharmaceutical supply chain (manufacturers, distributors, transportation providers, dispensers and consumers) to be aware of and take measures to protect themselves from theft, fraud, contamination, adulteration and counterfeiting.

Not only should members of the pharmaceutical supply chain protect the distribution process and the transaction but they should also verify, protect and authenticate their inventories by deploying solutions that guarantee the quality and efficacy of the product inside the container.

To learn more about these types of technologies, visit: http://www.xstreamsystems.net/.

Pharmaceutical Technology: New Treaty to Curb Counterfeit Drugs

Stephanie Sutton in a July 15th report in the electronic newsletter of Pharmaceutical Technology writes about a Council of Europe (CoE) Medcrime Treaty that is hoped will curb the lucrative global trade in counterfeit medications.

According to Ms. Sutton's story, the treaty is the first global convention against counterfeit pharmaceuticals and encourages cooperation among law enforcement agencies, customs, health professionals, and the judiciary.

“This treaty offers a comprehensive approach to tackling a crime that threatens public health and public healthcare systems,” said a spokesman, according to a news briefing from CoE.

“Counterfeit medicines are more lucrative than heroin. It is a vile crime to fraudulently provide patients with products that don’t work.”

Ms. Sutton writes:

· CoE has been long concerned about the absence of harmonized international legislation, nondeterrent sanctions, and the involvement of cross-border criminal organizations. Experts also believe the trend toward self-treatment has “flooded the Internet with medicines produced without any controls, tests or authorisation,” according to the news briefing.

· Another significant worry is the growing incidence of counterfeit medicines in supply chains. The healthcare systems of developing countries are particularly vulnerable to the mass entry of counterfeits; however, CoE believes that fake anticoagulation drugs may already have been taken by patients in the UK. Adultered antibiotics, cancer treatments, antipsychotic drugs, cholesterol-lowering treatments, and erectile dysfunction may also be present in Europe.

· According to CoE, counterfeiters are attracted by the potential for huge profits (i.e., economically motivated adulteration) coupled with low detection rates and comparative light penalties. The treaty will introduce tougher sanctions and help to ensure more effective pursuit of counterfeit manufacturers across international borders.

· The Medicrime Treaty will be opened for signatures later this year at a conference in Istanbul, which will be attended by representatives from more than 40 countries.

Secure Pharma Chain is encouraged by this step by the CoE to gain a more global, regulatory mandate to combat this deadly criminal act.

This treaty along with enhanced technologies and supply chain solutions are critical in eradicating the danger of bogus drugs to consumers around the globe.

To read the entire Pharmaceutical Technology story and see the text of the Medcrime Treaty, visit: http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=678874

Counterfeit Drugs: What the Doctor Didn't Order

Pharmaceutical-Technology.com features an excellent Q & A with several industry experts on the deadly global epidemic of counterfeit drugs.

The following are the ten questions and the responses from the July 20th Pharmaceutical-Technology.com Q & A:

As the number of counterfeit drugs on our streets continues to rise, Paul French asks Global Insight analysts Shuang Lewis and Denise Claux for the lowdown on the potentially deadly pills.

Research commissioned by the major drug companies suggests that the use of counterfeit drugs is on the rise. Would you agree?

Shuang Lewis: Yes, I'd agree that this is a trend we're seeing across many countries. The World Health Organisation (WHO) estimates that around 10% of drugs used worldwide are fake. The number varies from region to region but could be as high as 30% in Africa right now. And the signs are that the numbers are increasing year on year.

Denise Claux: In Brazil in 2008 the government seized 40t of counterfeit drugs coming into the country. In 2009 it was 333t. This to me shows two things – the problem is getting worse but also the authorities are getting better at finding these drugs as they come into the country.

Is it just a case of the major drugs companies, being concerned about protecting their patents from legitimate generic competitors, and wanting to sell more drugs by scaring people away from cheaper alternatives? Or is this a real problem?

Denise Claux: There is an issue with classification. For instance, a batch of generic Dutch drugs was recently confiscated on entry to Brazil because there was confusion between the two countries on what constituted a counterfeit drug. This kind of thing needs tightening up as statements about fake medicines create fear amongst patients. However, that's not to say there is no problem with counterfeit drugs. There is and it is very real.

So what sort of drugs are the counterfeit drugs mimicking? Is counterfeiting prevalent in a certain area of pharmaceuticals or all areas?

Shuang Lewis: Counterfeit drugs tend to be prevalent in therapeutic areas or at times of opportunity to cash in on lack of supply from legitimate sources.

For instance, during the swine flu pandemic, sales of fake medicines to combat it increased because there was a shortage of genuine Tamiflu available.

Weight loss is another area where counterfeit drugs capitalise on opportunity. Patients have to meet certain criteria in terms of their body mass index in regulated markets and if they can't get what they want, they can often find fake versions of what they're looking for elsewhere.

What about the geographical split? I heard that there's a lot of counterfeit anti-cancer and lifestyle drugs in the west whereas there's more anti-malaria and HIV fakes in developing countries like Africa? Is that right?

Denise Claux: I don't have any figures to prove that but it could well be a trend. Certain drugs are definitely more prevalent in some countries than others. For instance, erectile dysfunction drugs are the most commonly counterfeited drugs in Brazil. There are many factors behind this particular niche including availability and I guess social embarrassment. It's perhaps not the type of thing people want to go into chemists and ask for!

Do people take these medicines knowing they are counterfeit or do they believe them to be the real thing?

Shuang Lewis: It varies from case to case. Counterfeit drugs are often packaged up to look exactly like the drugs they're mimicking, so people would take them thinking they are legitimate drugs. In other cases people take counterfeit drugs knowingly because they are all they can afford or get hold of.

Why would people take these fake drugs instead of the real thing?

Denise Claux: The two main reasons are accessibility and cost. The price of medicinal drugs can be very high and sometimes the only way people can afford to take them is by getting them from the black market. If it's a choice of risking authenticity or not taking anything at all, of course people are going to be tempted into trying the drugs they can afford.

And if you're taking pills that have the wrong quantities of active ingredients inside, it can lead to health problems and even death.

Counterfeit drugs are so easy to get these days too. You can get hold of almost anything online, which can sometimes save people embarrassment if the drugs are for something they're not comfortable asking their pharmacist for. There's also a lot of unregistered pharmacies in places like Latin America, where fake drugs can be bought at knock-down prices.

So who’s producing these fake drugs and why?

Shuang Lewis: There are two types of counterfeit drugs – those with no actual medicine in and those that have the right ingredients but in the wrong quantities. Those with no active ingredients can be made by anyone, the others would probably need input from some kind of chemist but they’re all produced in factories that are not regulated.

Denise Claux: A lot of the counterfeit drugs in Western Europe are produced in factories in China and other developing markets and then smuggled across borders, just like cocaine and heroin.

What's the problem with taking counterfeit medicines? Aren't they just cheaper alternatives than the real thing?

Shuang Lewis: Some of the generic drugs can be cheaper alternatives to prescription drugs but most counterfeit medicines have significant health risks. If there is nothing actually in the tablets then by taking them, you're delaying the treatment you really need, which could be extremely harmful. And if you’re taking pills that have the wrong quantities of active ingredients inside, it can lead to health problems and even death.

So what's being done to counter the problem of counterfeit drugs?

Denise Claux: There are two levels of activity here. On a national level, governments like Bolivia are implementing national strategies and bringing in tougher penal codes for people caught making or selling counterfeit drugs. Brazil has also brought in a unique medicine identifying barcode to help them track the authenticity of drugs coming into the country.

The problem is that there's perhaps not enough being done yet on a regional level. The majority of counterfeit drugs in any given place come in from outside the country, but border patrols and customs officers are not yet proficient enough at detecting them.

Finally, what do you think the future holds for counterfeit drugs? Are they going to become increasingly prevalent or is it something that the authorities can get control of?

Denise Claux: It's a difficult trend to assess on a worldwide basis. Developing countries have different needs to the rest of the world but I think we could say that in the short-term, the number of counterfeit drugs available will continue to rise but as government initiatives to combat the problem begin to take effect, we could see an improvement in the longer term.

This Q & A had some interesting insight and statistics. Secure Pharma Chain believes, like these experts that the number of counterfeit drugs available world wide will continue to increase until regulatory authorities, the supply chain and consumers become more aware and take the necessary steps to eliminate and protect themselves from this potentially deadly criminal act.

To read the entire Pharmaceutical-Technology.com story, visit: http://www.pharmaceutical-technology.com/features/feature90441/?WT.mc_id=WN_Feat.

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

FreightWatch International: 2010 Bi-Annual Cargo Theft Report

FreightWatch International recently released its 2010 Bi-Annual Cargo Theft report.

As it relates to pharmaceutical cargo theft, FreightWatch is reporting the number of incidents has declined so far this year from last. However, the the overall volume or value of each incident and sophistication/organization has increased.

This seems to be exemplified by the huge Eli Lilly warehouse theft earlier this year where thieves stole $76 million in pharmaceuticals in a very sophisticated burglary.

Here are some of the highlights of the bi-annual report:

• In the first six months of 2010, cargo theft recorded by FreightWatch has increased 5% over the same time period in 2009. Additionally, there have been several noteworthy trends that differ from cargo theft recorded in the previous year.

• First, multi-trailer losses are becoming increasingly common. Cargo theft gangs are stealing two, three and even four trailers at a time, most commonly from terminals where trailers are more likely loaded with similar product. FreightWatch views this as the natural progression for cargo theft gangs, as they moved from "pot luck" style cargo theft to active targeting; now gangs are seeking a better return for their efforts, hitting multiple trailers at once while incurring the same level of risk.

• Second, Food and Drinks replaced Electronics as the commodity type most targeted by cargo theft gangs over the period examined. Electronic theft has decreased by 23% in the first half of 2010. As a point of comparison, at this same time last year, pharmaceutical thefts were down 50% over the previous year's rate, while the commodity group ended with a slight increase in volume for 2009.

• Third, in 2009, warehouse burglaries were up 50% over the previous year's rate, but slowed significantly through the rest of the year. FreightWatch recorded 12 warehouse burglaries in the first half of 2010, a decrease in the overall rate of incidents. However, due to a $76 million dollar loss in Enfield, Connecticut, the largest cargo theft incident on record, the total estimated loss rose sharply from $38 million in 2009 to $102 million in 2010.

The rise of the sophistication and organization of pharmaceutical cargo theft should trouble all within the pharmaceutical supply chain. This criminal act within the vital health care chain is evolving beyond random acts of theft and threatens the ability of all its members to protect their inventories, brand and safety of the consumer.

Secure Pharma Chain encourages all members of the pharmaceutical supply chain to utilize technologies to protect their inventories and authenticate all products within it.

To download this report in its entirety, visit: http://www.freightwatchintl.com.

FDA a Paper Tiger: China and the Heparin Probe

Ed Silverman on July 22nd blogs in Pharmalot about the questions being raised in Congress and within the media of the FDA’s lack of holding Chinese officials accountabile in tracking down the issue of the deadly Heparin issue that killed dozens in the US several years ago.

In this excellent blog post, Mr. Silverman highlights:

· ...how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation.

· You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there. Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger.

· “It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Joe Barton, the top Republican on the House Energy and Commerce Committee, tells the Wall Street Journal. He and Mike Burgess, another Texas Republican who is the ranking member on the Subcommittee on Oversight & Investigations, blast the FDA for not pressing the Chinese or acting on info obtained over the past two years . The probe, by the way, comes as FDA commish Margaret Hamburg prepares for her first trip to China.

· An FDA spokeswoman tells the Journal that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.” In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

· Chinese security authorities told a US official in Beijing in June 2008, that China wasn’t investigating the heparin episode as a criminal or administrative matter, he tells the paper.

This excellent blog brings to light the ability of the US government to properly investigate serious issues with quality, adulteration, fraud and counterfeiting with an important trading partner where a significant number consumer and health care products and their raw materials originate.

The lack of regulatory cooperation between nations is a serious concern to all within health care and its consumers.

Given the inability of the regulatory authorities to work together and properly vette and secure the global supply channels. Secure Pharma Chain believes that it is critical for all members of the global pharmaceutical supply chain to take measures to protect its inventories and brand by deploying technologies that validate the authenticity and efficacies of its products.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/china-stymies-fda-probe-into-contaminated-heparin/#more-25075

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

Pharmalot: Johnson & Johnson Gets Subpoena Over Recalls

Ed Silverman in Pharmalot reports today about the most recent wrinkle of a Federal Grand Jury Subpoena in the ongoing Johnson & Johnson recall saga.

During the an earning teleconference a Johnson & Johnson exec disclosed that the US Attorney’s Office in Philadelphia sent a grand jury subpoena about the vast and ongoing recall of millions of bottles of over-the-counter pediatric medicines by J&J’s McNeil Consumer Healthcare unit.

To read the entire Pharmalot blog post and another blog post regarding new legislation mandating drug recalls, visit: http://www.pharmalot.com/

Drug Safety Responsibility-For Whom Does the Finger Point?

This blog posting first appeared in Secure Pharma Chain in May 2008.

This posting still remains relevant today as the issue of poor quality, fraudulent, adulterated and counterfeit medications continues to proliferate in pharmaceutical supply chains around the globe-and the regulatory ability to meet this threat remains woefully inadequate.

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw. In reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply.

Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.Now it is the consumer who is doing the pointing and he or she is pointing at us all!

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

SecuringPharm.com: Thieves Make Off with Two GSK Shipments

Phil Taylor in a July 14th story in SecuringPharma.com updates and provides detail to the recent in-transit cargo theft of GlaxoSmithKline products in Pennsylvania late last month.

The thefts of the two trailers had a combined value estimated at about $400,000. One trailer load of products was recovered, thanks to an on-board GPS tracking device.

According to the SecuringPharma.com story:

• The two trailer loads contained personal care products such as Aquafresh mouthwash and Sensodyne toothpaste and were taken at a logistics provider terminal in York. The thieves moved the loads to another logistics provider site, stole a tractor fitted with the GPS device, and drove one of the trailers away. It was subsequently recovered with about two-thirds of its contents in New Jersey. The other trailer remains unaccounted for, according to an update from the Pharmaceutical Cargo Security Consortium.

The SecuringPharma.com piece also included some news on two other pharmaceutical cargo thefts:

• The Florida TOMCATS - a specialist police group focusing on cargo theft - has recovered a load of around 35,000 albuterol 3ml vials worth around $500,000 which had been stolen back in August 2009. The theft occurred whilst in transit from a manufacturing site in South Carolina to a distribution centre in Texas.


• Proctor & Gamble lost a shipment of its products (assorted razors and related items) worth over $600,000 from a truckstop in Iowa on July 3. The load was being carried by shipping firm Schneider National.

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 all of Phil Taylor’s story, visit: http://www.securingpharma.com/40/articles/522.php

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

Pharmalot: J&J Fires 300 Employees Over the Tylenol Recalls

Once again Ed Silverman in his Pharmalot blog continues to maintain the best insight and commentary on the never ending J&J Recall scandal.

In a July 15th blog, Mr. Silverman reports on J&J’s recent publicly released statement which included the announcement that they will fire 300 to 400 people who work in the Fort Washington, Pennsylvania McNeil plant. This is the site and headquarters where most of the quality-control problems were found and the managerial decisions were made.

Mr. Silverman’s Pharmalot commentary included:

· The healthcare giant submitted its long-awaited remediation plan to the FDA today - you know, the plan that is supposed to help Johnson & Johnson’s McNeil Consumer Healthcare unit get back on track after recalling tens of millions of over-the-counter pediatric medicines. And in a vague statement, J&J says one way to cope is to can 300 of the 400-plus people who work at the Fort Washington, Pa., plant where most of the quality-control problems were found and managerial decisions were made.

· The employees are being let go because it’s not clear when the plant will operate again. A J&J spokeswoman says the “best estimate” is the middle of 2011. Recently, J&J acknowledged that a few hundred million dollars in sales will be lost; the average annual sales of the products made at this plant over the last three years were about $650 million, although that remains a sliver of J&J consumer sales, which last year were $4.2 billion out of $16.5 billion total sales worldwide. J&J vows to expand capacity elsewhere to compensate for the shortages.

· There was no word, however, whether any senior McNeil execs are among those being shown the door, given that the McNeil unit is headquartered in Fort Washington. Take Peter Luther, who heads the unit. He allegedly recommended a recall of Motrin pills without notifying the FDA or the public.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/jj-fires-300-employees-over-the-tylenol-recalls/#more-24878.

As quality control issues continue to dog large branded and generic pharmaceutical companies it is vital that all members of the pharmaceutical supply chain monitor the quality and protect their inventories in order to make certain that health care consumers have access to safe and efficacious medications.

Secure Pharma Chain Blog endorses material authentication which can be deployed easily and efficiently within the supply chain to verify the authenticity and quality of medications within their unit of sale container.

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

FreightWatch International: June 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 June 2010.

FreightWatch recorded 54 cargo theft incidents in North America during June; a decrease of 14% from May.

By commodity, pharmaceuticals experienced one incident in June, one less than in May. However the in subsequent follow up reports may prove that were more stolen cargo than initially reported in this particular incident.

The one pharmaceutical theft in the report is:

• The June 25th trailer theft of a trailer of pharmaceutical products in Glade Springs, Virginia with an unreported value. This theft was quickly recovered because of tracking devices placed within the stolen cargo. The theft was reported in Secure Pharma Chain Blog.

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/.

BusinessWeek: Pfizer Taking the Financial Spoils of Counterfeiters

Simeon Bennett in the July 8th BusinessWeek, writes about Pfizer going after the financial spoils of convicted counterfeiters.

Overall this is an excellent encapsulation of a new tactic of Big Pharma of attacking counterfeiters financially while detailing with excellent statistics and examples of the overall danger of this issue.

Initially, the story details the case of Martin Hickman, who made a fortune and is now one of the first successes of Pfizer’s new strategy.

Hickman between 2003 and 2007 sold more that $8.9 million of bogus Viagra and other drugs via 150 websites according to Britain’s MHRA.

Hickman used the proceeds of his counterfeiting business to by a high end flat in Chelsea, a villa in Spain, Bentley, Range Rover and hundreds of thousands of dollars of jewelry.

According to Pfizer when Hickman was finally caught in 2007 for his illegal activities he was sentenced to only 3 months in jail for contempt of court and ordered to stop advertising Viagra on his websites. This lax penalty forced Pfizer to employ other tactics to fight counterfeiters.

Highlights from the BusinessWeek piece on Hickman and the Pfizer strategy are:

• “The point is to make them realize that there’s no sense from a business perspective in counterfeiting our products, because if we find you, we’re taking your money away,” says John P. Clark, a 55-year-old U.S. law enforcement veteran who now serves as New York-based Pfizer’s chief security officer.
• The spoils of Hickman’s crimes helped settle a trademark infringement lawsuit brought by the world’s largest drugmaker three years ago. It’s the biggest example of a new approach Pfizer is taking to fight counterfeiting of prescription drugs, an industry that’s almost doubled to $75 billion over five years, according to the New York-based Center for Medicine in the Public Interest.
• Pfizer, whose erectile dysfunction pill Viagra is one of the most copied medicines, once relied on local authorities and criminal courts to hunt down offenders. Now it’s taken matters into its own hands, hiring former U.S. customs officials, FBI agents, Turkish narcotics experts and Hong Kong police to hunt counterfeiters. In China, they’re tracking fakes to the source, raiding derelict warehouses for evidence of illegal drug-making. In the U.K., they’re using civil courts to hit fake pill peddlers where it hurts most.
• Previously, the company would refer cases of counterfeiting to regulators and police for criminal prosecution. Civil suits allow Pfizer to conduct investigations and raids itself with a judge’s authorization, according to Clark.
• In a second criminal prosecution in June last year, Hickman pleaded guilty to six counts of selling and supplying fake and unlicensed medicines and money laundering, and was sentenced to two years’ jail, according to the MHRA. The regulator is now taking legal action to seize his assets, William Mach, a spokesman for the MHRA, said in an e-mail.

As it relates to the industry and the scope of the issue, Mr. Bennett’s piece includes:

• Pfizer isn’t alone in taking civil action. Eli Lilly & Co., the maker of the impotence drug Cialis, investigates phony pill makers with Pfizer because their products are often copied together, said Bruce Longbottom, legal counsel for Indianapolis- based Lilly.
• “The civil action gives the financial deterrent where they’re actually hit in the pocket book,” Longbottom said in a telephone interview. “We do think that sends a message that’s a little bit different from what a criminal action might give us.”
• International criminal syndicates are increasingly turning to prescription drugs because they offer higher returns and lower risks than narcotics, according to Aline Plancon, an Interpol officer who works with police worldwide to investigate counterfeiters.
• “These people mastered the technology of making pills, because they are doing narcotics,” she said. “They know that the risks of being punished are low compared to the benefit.” Plancon estimates that $1,000 spent making heroin can earn a return of $20,000. The same investment in copied medicines can earn as much as $450,000.
• The global trade in counterfeit drugs will rise to $90 billion by 2015, according to the Center for Medicine in the Public Interest. The Organization for Economic Cooperation and Development says it’s hard to put a value on the problem because of “a paucity of reliable data.” Trade in all counterfeit and pirated goods rose to about $250 billion in 2007 from about $200 billion in 2005, the OECD estimated in November.
• There were 2,003 discoveries of counterfeit, illegally diverted or stolen medicines worldwide last year, compared with 195 reported in 2002, according to the Pharmaceutical Security Institute, a Vienna, Virginia-based nonprofit organization that monitors fake medicines.

Bennett's backgrond on the human toll of counterfeiting include:

• Counterfeits take a toll on human life. Fake medicines against malaria and tuberculosis alone are responsible for about 700,000 deaths a year, the London-based International Policy Network estimated in a report last year.
• “A mother who buys fake medicine to treat malaria does not know that she is paying for her own death or that of her sick child,” Jacques Chirac, a former president of France, said in a speech to the World Customs Organization’s council on June 24. Chirac’s charitable foundation is working to combat fake drugs.
• In the U.K., Pfizer says its civil suits have reduced the availability of fake drugs over the Internet. The drugmaker says it has sued at least seven other counterfeiters there, and last month settled its first civil suit in the U.S.
• “Even if you have a few bucks, we’re going to take it,” Clark says. “It’s not going to be there in the Caymans, so you can’t turn around and just tap your bank account and start the operation over again.”

Secure Pharma Chain Blog is excited about Pfizer’s and Pharma's new strategy to go after the proceeds of this criminal act and encourages all members of the supply chain to take further proactive steps including the deployment of anti-counterfeiting technologies to interdict this deadly threat before it reaches consumers.

To learn more about anti-counterfeiting technology: http://www.xstreamsystems.net/.

To read the entire BusinessWeek article, visit: http://www.businessweek.com/news/2010-07-08/pfizer-spies-find-spanish-villa-gold-rolex-in-fake-viagra-bust.html.

CNBC Video: Combating Counterfeit Drugs

The following short video report appeared on CNBC on July 6th as a precursor to their major network story titled, Crime Inc. Counterfeit Goods.

The expose’ premiers Wednesday, July 14, 2010 9pm eastern on CNBC. Although it is a global report on the criminal act of counterfeiting in general, pharmaceutical counterfeiting is obviously one of the more relevant, sizeable, profitable and dangerous aspects of this growing world wide issue.

Secure Pharma Chain Blog encourages media making the industry and consumers aware of the dangers and prevalence of this deadly scourge.

Bristol-Myers Squibb Recalls Lots of Coumadin

Bristol-Myers Squibb is recalling eight production lots of its anti-clotting drug Coumadin because the amount of the active ingredient in the drug could change.

Bristol-Myers Squibb (BMS) is recalling a total of 144,672 1-milligram tablets of Coumadin, all of which were distributed in the U.S. The recall includes five production lots of Coumadin hospital unit doses and three lots of physician samples. All the tablets were distributed in blisterpacks, no bottled medicine or other doses are involved.

The company said the recall is a precaution, and no side effects have been reported.

BMS said the amount of isopropanol in the tablets could change over time. Isopropanol, or isopropyl alcohol, is used to keep the drug's active ingredient in a crystalline state. The changing levels of isopropanol could increase or reduce the amount of the active ingredient in the tablets.

Secure Pharma Chain Blog endorses the use of authentication technologies to verify the efficacy, quality and effectiveness of pharmaceutical products inside their unit of sale containers within the supply chain.

SecuringPharma: Anti-Counterfeit Technology Market Set for 'Steady' Growth

“The fundamental market drivers for anti-counterfeit technologies remain strong.”

In a July 12th story posted on SecuringPharma.com, they report on a Global Industry Analysts (GIA) study regarding the market for anti-counterfeiting technologies.

In the report the GIA states that the global market for anti-counterfeiting technologies could reach $82.2bn by 2015. The GIA says that the food and pharmaceutical industries are currently the most vulnerable to the actions of counterfeiters and that the pharmaceutical and food companies suffer "substantial" losses every year from counterfeiting. These losses are encouraging various strategies to prevent brand damage, including investments in anti-counterfeit technologies.

Included in the SecuringPharma story:

• With the security threat graph spiking a tad too rapidly for manufacturer’s comfort, demand for anti-counterfeit products and services is experiencing a steady rise," says the report, which notes that holograms, tamper-evident closures, taggants and markings and RFID labels will all play their part in the fight against counterfeiting.

• GIA also note that this increase in investment in technologies is coming despite the downturn in the global economy, helped by regulatory drivers including US and EU moves towards serialization and track-and-trace for pharmaceuticals.

• North America and Europe collectively account for a major share of the global anti-counterfeit packaging market, according to GIA, and brand owners there are increasingly investing in multilayered brand protection using overt, covert and forensic technologies.

• "Government regulations necessitating the need for anti-counterfeit technologies are the silver lining from the downturn in the global economy [and] the present recessionary climate also makes sense to invest in anti-counterfeit packaging to gain back the lost sales from the counterfeiters."

Secure Pharma Chain Blog is encouraged by the GIA report and endorses that all members for the pharmaceutical supply chain protect their brand, limit their liability, manage costs, secure inventories and ultimately protect consumers by deploying anti-counterfeiting technologies.

It is vital that these technologies continue to be deployed to protect the global supply chain from poor qualtiy, fraudulent and counterfeit drugs.

To read the SecuringPharma.com post, visit: http://www.securingpharma.com/40/articles/520.php.

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

Johnson & Johnson, The Recalls Continue

J&J recalls more Tylenol, over-the-counter drugs, recalled lots linked to odors.

Johnson & Johnson recalled more Tylenol and other over-the-counter drugs on July 8th after the 21 lots of Tylenol, Benadryl and Motrin were linked to a musty or moldy odor. This action continues to expand a recall the company’s McNeil Consumer Healthcare unit started in January.

Johnson & Johnson’s McNeil Consumer Healthcare unit said the latest recall involved 21 lots of medications, including Tylenol for children and adults, several forms of Benadryl allergy tablets and Motrin painkiller. However J&J spokesperson Bonnie Jacobs was unable to disclose how many pieces were in each lot or give a total number of items involved.

Thursday's recall, like the one in June, was related to J&J's January recall of 53 million bottles of widely used products, which were also linked to odors.

On June 15, J&J recalled four lots of Benadryl and one lot of Extra Strength Tylenol gels.

"These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots," Johnson & Johnson said in a press statement.

As with the previous recalls, Johnson & Johnson are encouraging consumers who have purchased the products included in the recall should stop taking them and contact the company about a refund or replacement

Not counting the subsequent follow up recalls to the January 15th recall, McNeil has issued four product recalls in the past year due to quality control problems at its plants, sparking a congressional investigation and scrutiny from the U.S. Food and Drug Administration.

Secure Pharma Chain Blog encourages all within the pharmaceutical supply chain to authenticate and verify the quality of their inventories while protecting consumers from fraud, adulteration and counterfeit product.

To learn more about pharmaceutical supply chain solutions to quality control and product authentication, visit: http://www.xstreamsystems.net/.

FDA: Counterfeit Alli Contains 3 Times Daily Dose

The U.S. Food and Drug Administration is announcing that recently confiscated Counterfeit pills of the diet drug Alli contain up to three times of an active ingredient, which may be harmful to consumers.

Earlier this month, the FDA warned consumers about the counterfeit Alli pills circulating on the Internet and for sale in online auction sites. Alli is the brand name for the drug orlistat, but the counterfeit drugs being passed off as Alli contain a different stimulant drug, sibutramine.

The bogus drugs discovered were counterfeits of Alli 60 mg capsules sold in 120-count refill packs, officials said.

Alli is an FDA-approved over-the-counter weight loss drug made by GlaxoSmithKline.

Following laboratory testing, the FDA now has determined that the counterfeit Alli pills contain up to three times the usual daily dose of sibutramine if they are following the dosing instructions for Alli.

According to the FDA, that much sibutramine may cause health individuals to develop anxiety, nausea, heart palpitations, accelerated heart beat (tachycardia), insomnia, and increased blood pressure.

Also, such high levels of sibutramine can be fatal for patients with histories of cardiovascular disease and can cause high blood pressure, stroke, and heart attack.

Consumers first began reporting their suspicions of the counterfeit Alli to GlaxoSmithKline in early December 2009, officials said.

The bogus Alli product looks similar to the authentic product, but there are a few notable differences:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.

Secure Pharma Chain Blog encourages all consumers to only purchase pharmaceuticals through internet sites that are affiliated with a reputable pharmacy or that are sanctioned by the National Boards of Pharmacy through their VIPP accreditation. Never buy from an internet site that does not require a prescription from your individual physician.

In addition Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain use authentication technologies to verify and secure their inventories to protect both their brand and all health care consumers.

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

AllAfrica.com: Nigerian Customs Hands Fake Drug Importer to NAFDAC

As reported in the June 29th edition of AllAfrica.com, the Nigerian Customs Service FCT handed over a suspected fake drug and contraband textile materials importer to the Nigerian National Agency for Food, Drugs and Control (NAFDAC).

According to All Africa.com:

· In a press conference, Usman K. Bellow, the Customs Area Comptroller, FTC Command stated that the suspect, Mrs Anyaoha Ngozi Margret was arrested at the airport with 12 bags of CIPRO tabs 500mg and 87 veils of textile materials.He said following the request from NAFDAC, the Comptroller General of Customs, Abdullahi Dikko Inde approved the handing over of the suspect and the medicaments to them.
· Bello said it is very disheartening to see Nigerian traders importing fake medicaments with the intention of selling to unsuspected Nigerians who will eventually be harm by the drugs.
· He said: "It is really a very bad and sad way of making money while killing innocent Nigerians. It should be noted that importation of pharmaceuticals are allowed by law. These items are dutiable not banned but there is a procedure such as registration of NAFDAC etc."
· The comptroller also warned Nigerians to desist from smuggling contraband goods such as textile materials, adding that the nefarious crime is responsible for crippling the country's economy especially the manufacturing sector.

Secure Pharma Chain Blog is encouraged by this latest interdiction in Nigeria an area impacted especially hard by the deadly crime of pharmaceutical counterfeiting and encourages all members of the pharmaceutical supply chain to enhance their protection of inventories by deploying anti-counterfeiting technologies and solutions.

To read the entire AllAfrica.com story, visit: http://allafrica.com/stories/201006300123.html.

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

Drug Cargo Theft: The New Goldmine

Top 10 Pharma Cargo Thefts By Value

Eric Duggan in the June 29th edition of the FiercePharma Manufacturing, writes an excellent story encapsulating the proliferation of pharmaceutical cargo theft and how it has become one of the most profitable and dangerous crimes to the public-at-large in the 21st century.

The story, aptly titled Drug Cargo Theft: The New Goldmine, describes how this specific criminal activity is likely to continue to grow because of the huge profits gleaned from targeting pharmaceuticals.

Mr. Duggan presents the listing of the top 10 ten pharmaceutical thefts in the 2009 and 2010 to-date, which with few exceptions, seem to have been lightly reported about in the media or otherwise not well known by the general public.

The reality is that with relative ease, a criminal can target a pharmaceutical shipment or warehouse and potentially make millions on the sale of the stolen product along with the ability to gain significantly more by other illegal activities after the fact.

The following is a list of the Top Ten Pharmaceutical Thefts of 2009 and 2010 (to date):

• Eli Lilly Warehouse - $76M
• Eli Lilly Truck - $37M
• Teva Truck - $11.8M
• Novo Nordisk Truck - $11
• Astellas Truck - $10M
• Unknown company - $8.8M
• GSK Warehouse - $5M
• Exel Distribution Center - $3M
• Dey Pharmaceuticals Truck - $2M
• Dey Pharmaceuticals Truck - $2M

With hundreds of millions of dollars of pharmaceuticals cycling through a black market the criminals have the ability to double their profits of the theft by separating the product from the packaging, selling the product and then put counterfeit product into the packaging and sell that as well.

With the advent of the internet, there is also a ready made, anonymous tool to market their stolen and fraudulent goods directly into consumers and the legitimate supply channel for even higher margins.

In a sense pharmaceutical cargo theft and its down stream activity seemingly is a perfect crime. It has high profitability, there is the ability to double dip on the spoils of their theft by adding counterfeit product to packaging and they can sell their stolen wares into legitimate supply chains globally through the anonymity of the internet.

Here are some of the highlights of Mr. Duggan’s FiercePharma story:

• Stolen drugs are most often shipped to Latin America or to illegal online pharmacies. Sometimes they also make their way back into the legitimate supply chain with new fake labels. This poses a potent public health risk that keeps the FDA involved, issuing recalls and investigating cases through its Office of Criminal Investigations.

• Aside from the appealing pay-off, cargo theft has gained momentum in the U.S. because of the relatively light penalty thieves risk if caught. As reported in Security Director News, cargo theft in the past has been viewed as a victimless crime, leading to slow response from law enforcement. According to Keith Lewis, task force agent for the major theft unit of the Georgia Bureau of Investigation, "This is a very easy crime to commit and get away with. Law enforcement does not understand the nature of this crime." courtesy of FreightWatch International.

Fortunately Mr. Duggan offers some hope that there are some efforts being made to combat this crime:

• Greater industry efforts to combat the crime are already having an effect, however. The Transported Asset Protection Association (TAPA) offers a snapshot of cargo-theft in its 2009 incident information report, noting, "With an insight into the industry, the data signify the beginnings of a trend toward improvement--and a greater adherence to supply chain security practices throughout the pharmaceutical supply chain."

• Cooperation is improving between industry and law-enforcement. Companies like FreightWatch and the newly minted CargoNet offer loss control services, including compiling crime data and coordinating with law enforcement. CargoNet managing director Maurizio Scrofani told us, "There is a problem in fragmentation [of data]. You need a central database to tie in regional databases, which is a common way of pulling in law enforcement."

The era of pharmaceuticals targeted for criminal activity carries a huge price tag to the downstream consumer with the potentially deadly effects of contamination, adulteration and counterfeiting impacting the health of large groups of a population.

Secure Pharma Chain Blog encourages all members of the supply chain to deploy technologies and solutions to both secure and authenticate their inventories from the criminal acts of theft, fraud, adulteration and counterfeiting.

Read more of the FiecePharma article, visit: ttp://www.fiercepharmamanufacturing.com/special-reports/top-10-pharma-cargo-thefts-value-2009-2010?utm_medium=nl&utm_source=internal#ixzz0sR3PFWnN

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