SecuringPharma: Survey Results Suggest Drug Counterfeiting is on the Rise

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

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

According to the SecuringPharma post:

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

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

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

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

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

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

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

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

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

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

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

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

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/.

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

Canadian Man Pleads Guilty to Selling Counterfeit Cancer Drugs

Tuesday, Hazim Gaber, 22 of Edmonton, Canada, pleaded guilty to selling counterfeit cancer drugs over the internet. Gaber admitted selling what he falsely claimed was the experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the United States, Canada, the United Kingdom, Belgium and the Netherlands between October and November 2007. According to the plea agreement, Gaber charged $23.68 for 10 grams of the purported DCA, $45.52 for 20 grams or $110.27 for 100 grams, plus shipping.

DCA is an experimental cancer drug not yet approved for use in the United States or Canada. DCA is an odorless, colorless, inexpensive, relatively non-toxic experimental cancer drug that is highly sought after by cancer patients. A doctor at the University of Alberta in Canada published a report in early 2007 summarizing the results of a study, which showed that DCA caused regression in several cancers, including lung cancer, breast cancer, and cancerous brain tumors.

Gaber sold the counterfeits through a website named DCAdvice.com, which falsely claimed that it was the only authorized representative to sell DCA and was affiliated with the University of Alberta. Further lab analysis determined that the substances sold contained starch, dextrin, dextrose or lactose, and contained no DCA.

Gaber faces a maximum prison sentence of 20 years on each of the five counts of wire fraud to which he pleaded guilty. Gaber also faces maximum fines of $250,000 per count. As part of the plea agreement, Gaber agreed to forfeit or cancel any website, domain name or Internet services account related to this fraud scheme.


XStream System applauds all the regulatory and enforcement agencies involved in the capture of this counterfeiter: Criminal Division’s Computer Crime, Intellectual Property Section, Assistant U.S. Attorney Peter Sexton of the U.S. Attorney’s Office for the District of Arizona. the Edmonton Police Service, the Alberta Justice Office of Special Prosecutions-Edmonton, the Competition Bureau of Canada, the U.S. Postal Inspection Service, the Federal Trade Commission and the Alberta Partnership Against Cross Border Fraud, The Criminal Division’s Office of International Affairs and the Phoenix FBI Cyber Squad.

To view the Dept of Justice Press Release visit: www.justice.gov.

To view information regarding counterfeit detection solutions visit: www.xstreamsystems.net.

The Economist: The Spread of Counterfeiting, Knock-offs Catch On

Fake goods are proliferating, to the dismay of companies and governments, reports The Economist in a story that appeared in their March 4, 2010 edition.

The piece details the overall impact of counterfeiting in all marketplaces, its spread and impact to economies and consumers.

The impact of counterfeits hits everywhere, according to the article, “fake Porches and Ferraris zoom along the streets of China. A German bank has discovered an ersatz gold ingot made of tungsten in its reserves…NASA, America’s space agency, has even bought suspect materials.”

This story encapsulates how prevalent this criminal activity has become and that it not just a victimless crime of a bunch of knock-off purses or watches sold on the street corner.

Highlights of the article include:

· The OECD estimates that the international trade in counterfeit and pirated goods was worth around $250 billion in 2007. The International Anti-Counterfeiting Coalition (IACC), a lobby group, says the true figure is actually closer to $600 billion, because the OECD’s estimate does not include online piracy or counterfeits that are sold in the same country as they are made. Counterfeit goods make up 5-7% of world trade, according to the IACC.

· Several factors have contributed to the growth of counterfeiting in recent years. The shift of much of the world’s manufacturing to countries with poor protection of intellectual property has provided both the technology and the opportunity to make knock-offs. The internet in general and e-commerce sites like eBay in particular, have made it easier to distribute counterfeit goods. MarkMonitor, a firm that helps companies defend brands online, estimates that sales of counterfeit goods via the internet will reach $135 billion this year.

· The recession in the rich world may also have given a boost to counterfeit goods. Frederick Mostert of the Authentics Foundation, an anti-counterfeiting group, has noticed a “spike” in knock-offs this recession, as consumers short of money trade down from the real thing. Cost-cutting measures may also have made firms’ supply chains more vulnerable to counterfeit parts.

· Governments are also boosting their efforts to crack down on counterfeiting, which deprive them of tax revenue in addition to harming legitimate businesses. Counterfeiting and piracy cost G20 economies €62 billion ($85 billion) a year in lost taxes and higher spending on unemployment benefits, according to a study by Frontier Economics, a consultancy. For every dollar invested in the fight against counterfeiting in America, the government receives $5 in extra tax revenue, estimates the US Chamber of Commerce, a business lobby.

· In 2008 the value of fake goods seized at America’s borders increased by nearly 40% over the year before. It subsequently fell by 4% last year—far less than the 25% decline in imports overall. In Europe in 2008 customs services confiscated more than double the previous year’s haul of counterfeit goods.

· MarkMonitor raised the price of its online brand-protection service by 18% last year because demand was so high. America’s biggest firms spend $2m-4m a year to combat counterfeiting on average—a figure that is growing along with internet shopping.

· In China, where 80% of the world’s fake goods are thought to be produced, officials are loth to crack down on a thriving local business.

Secure Pharma Chain Blog continues to highlight medication counterfeiting as one of the most dangerous forms of this criminal activity and encourages all within the pharmaceutical supply chains to deploy a variety of solutions and technologies in their efforts to protect the healthcare of the consumer.

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

To read this excellent article which appeared in the March 4th edition of The Economist, visit: http://www.economist.com/.

WSJ: US Authorities Investigating Alleged Sales Of Counterfeit Insulin Test Strips

Peter Loftus in the Wall Street Journal reports that the US government is currently investigating a Florida businessman who Johnson & Johnson says sold counterfeit versions of its OneTouch diabetes test strips.

J & J has aggressively conducted this investigation, which it says involves participants in China, Pakistan and the US, for the last four years.

According to the WSJ, if charges are filed against the US distributor, Jacques Duplessis, it would be the first instance resulting from J&J's four-year effort. Notably, a 2006 FDA alert about the counterfeit strips warned that they could give inaccurate readings, causing diabetes patients to take either too much, or too little, insulin.

This incident is very relevant in that it shows that the prevalence of counterfeit medications and devices that have been a major issue in the rest of the world outside of the United States has been impacting our consumers and will likely proliferate further.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain to use a variety of technology solutions to secure their inventories specifically material authentication which allows the user to verify the molecular fingerprint of the tested material inside its unit-of-sale container.

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

To read the WSJ article, visit: http://online.wsj.com/article/SB10001424052702303591204575169990446786552.html.

XStream Systems Presents Quad Layer of Protection against Counterfeit Drugs

With an invitation from Pfizer Inc.. and Dr. Mohammed Abuelkhair, Head, Pharma/Medicine and Medical Products Regulation Section – Health Authority Abu Dhabi, XStream Systems had the opportunity to present at the joint Regional Conference on Fighting Counterfeit Medicines in Dubai December 15 and 16, 2009.

Representing XStream Systems were Brian Mayo, President and CTO, Patricia Earl, Vice President Business Development and Simon Irish, XStream Systems’ Director.

XStream Systems representatives had an opportunity to interact with officials from the Ministries of Health, Police, and Customs representing governments of the Middle East and North Africa region.

On the second day of the conference XStream Systems’ President formally presented the company’s vision of the “Quad-Layer Approach” that integrates molecular screening, serialization, sealants and pedigree. He shared with the attendees that this was an all-encompassing system that will deliver a seamless method of counterfeit control and product integrity assurance, and, in this regard discussed XStream Systems’ on-going collaboration with the Kodak Security Solutions and use of the Traceless System for Anti-Counterfeiting.

To view entire article visit: www.xstreamsystems.net.

Anti-Counterfeiting: Thinking Inside the Box

The Autumn 2009 issue of Pharmaceutical Manufacturer and Packing Sourcer (PMPS) features an editorial article written by XStream Systems’ Senior Vice President, Alan Clock.

The editorial piece discusses analyzes the various segments of anti-counterfeiting technology and introducing EDXRD and material screening as a robust tool in combating counterfeit, adulterated and fraudulent medications within the global supply chain.

The phrase, “Thinking Inside the Box” refers to EDXRD’s capability to screen and authenticate materials inside their sealed, unit-of-sale containers without destroying or degrading the materials. This unique solution allows all members of the pharmaceutical supply chain to efficiently, accurately and inexpensively test and screen product to ensure that their inventories are safe and efficacious.

Here is an excerpt from the article:

Today, the various members of the pharmaceutical supply chain find themselves in an expanding global marketplace and in the midst of an ever growing epidemic that threatens each relevant party. As globalization increases, so too does the risk of counterfeit, substandard or fraudulent medications within the supply chain. This increase in risk threatens both the economic and physical health of the pharmaceutical industry and its consumers. Here are a few staggering statistics related to this scourge:

• The World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion global industry in 2010.
• The WHO projects the annual growth of counterfeit medications to be between 12 and 16 per cent annually, worldwide.
• According to the WHO, more than 2,000 children in Africa alone die each day as a result of taking counterfeit medications.
• The WHO reports that, across the world, 10 per cent of pharmaceuticals are counterfeit, fraudulent or adulterated. Proliferation and percentages are much higher in developing countries in Asia, Africa and South America, with up to 50 per cent of the supply chain projected to be identified as counterfeit or adulterated.

TRACK AND TRACE

To date, nearly all of the solutions for this global epidemic emphasize what are known as ‘track and trace’ methods (such as barcodes, holograms, RFID, pedigree, taggants and serialization). These solutions are primarily based on traditional technology for inventory control and security and are common within most sophisticated supply chains. They are incredibly effective in tracking products, especially in direct or short supply chains, where the additional cost can be justified in their inventory control capabilities because the members of the supply chain use common systems and tools for tracking, distribution and sales. However, track and trace solutions have their limitations. They generally require some sort of addition to the outside of the box or package, and a common technology to be read and documented. These processes and technologies add further cost to the product and are difficult to maintain across large global supply chains. In addition, because of its external placement, the track and trace item may be easily replicated, and it does not verify that the material inside the package is safe and efficacious.

To read the complete article either visit PMPS at www.samedanltd.com/magazine/15/issue/122/article/2531 or visit XStream Systems website at www.xstreamsystems.net.

Turkish Government to Delay Implementation of Barcode System to Stamp Out counterfeit Drugs

Initiative officially delayed until October, but industry experts anticipate the process to be pushed back further.

The Turkish newspaper, Today’s Zaman recently published a story about the implementation of a drug tracking barcode system in place to combat counterfeit drug in Turkey. However since the publication of the article, pressure from pharmacies has delayed the implementation from July to October. Most industry experts expect the delays to go beyond the October schedule because of the significant costs to small dispensing pharmacies.

According to the article:

• Turkey is identified as being one of the largest global purveyors of counterfeit drugs.


• The ambitious tracking system, which industry insiders estimate has already cost more than $200 million this year alone in the run-up to its implementation, has been fraught with difficulties.


• Dr. Roger Bate in last week's Journal of the American Enterprise Institute, his limited study of a small sample of drugs in the US purchased over the Internet revealed that Turkey is the largest single supplier of drugs bought online in the US. He documented a number of raids in Turkey that revealed all aspects of the counterfeit drug trade -- importers and local manufacturers of counterfeit products, wholesale distributors repackaging fake and old medicines that should have been destroyed and printers making packaging for the manufacturers. “The products I have seen,” he told Today's Zaman, “were manufactured by large Western companies in Turkey for the Turkish market which were diverted -- possibly illegally -- to the US by Internet sellers.”


• The implementation of this system is also meant to act as a prevention of fraud against the medical insurance system, which is being defrauded by unscrupulous doctors and pharmacists hungry to take advantage of the easily cheated system.


• Pharmaceutical companies -- the ones whose pocket books are arguably most affected by the proliferation of counterfeit drugs in Turkey -- have been amongst those who were resisting the implementation of the barcode system.

Most have said that this program which is slated to use a GS1-compliant 2D barcode will cost the country over $150m per year. The delay in this program is seen as a major setback to companies who tout track and trace technologies as the answer to counterfeit and adulterated medications.

XStream endorses all solutions to the issue of counterfeit, adulterated and diverted medications and believes that a comprehensive suite of technologies are necessary to adequately protect the global pharmaceutical supply chain. XStream believes that autentication and verification of the contents of the unit of sale, which is available via its XT250, is a critically important componant to securing medications from production to dispensing.

To read the entire article, access the link below:
http://www.todayszaman.com/tz-web/news-184271-105-barcode-system-to-stamp-out-counterfeit-drugs.html

To learn more about the XT250 visit us at:

http://www.xstreamsystems.net/

Global Health Change: Counterfeit Medicine

Alanna Shaikh, in a July 17th GlobalHealth.Change.Org posting reports on “a future of cat and mouse between manufacturers of fake medicines and the technology that detects it.”

Here are several strong quotes from the posting:

• The proliferation of new medicines will make it easier to slip a fake into the mix; so will the increasing capacity to produce authentic looking fake pills and packaging. At the same time, a host of innovation ideas for authenticating medicine are taking hold. At any given moment, the balance will be in favor of either the black market or the legitimate manufacturers.


• The drugs that get counterfeited tend to be the most important ones. Anti-retrovirals, tuberculosis drugs, anti-malarial medications.


• The worst fake medicines contain the drugs they claim to, but in amounts too small to do any good. Instead, they lead to resistance from the microbes they are meant to eliminate.


• According to one source, between 50% and 90& of drugs in some African and Asian countries are counterfeit.


• Technology is neutral. It's also increasing the ways that we can detect and eliminate counterfeit medicines.

XStream Systems believes that its technology, which uses EDXRD and allows the user to authenticate medications non-destructively inside their sealed container is a significant step forward in combating this global issue.

To read the entire posting follow this link:
http://globalhealth.change.org/blog/view/friday_futures_counterfeit_medicine

COMBATING THE SPREAD OF FAKE DRUGS

In the June 28, 2009 Online Issue Daily Policy Digest, the National Center for Policy Analysis highlights a very relevant policy document titled, "Keeping It Real: Combating the Spread of Fake Drugs in Poor Countries" by Julian Harris, Philip Stevens and Julian Morris of the International Policy Network.

XStream endorses the primary assertion that one of the most effective ways in combating this international problem is for the private sector of the pharmaceutical supply chain to take advantage of its innovative capacity to experiment with various technological solutions that enable it to protect the identity of its products. Members of the pharmaceutical supply chain need to utilize a variety of technologies, like XStream’s XT250 solution which allows the end user to verify and authenticate medications inside its sealed manufacturer’s unit of sale container without destroying or degrading the material.

The text of the Daily Policy Digest review on "Keeping It Real":

Counterfeit and substandard drugs are a serious and growing problem around the world -- especially in less developed countries. These fake drugs pose three direct threats to patients: failure to provide effective treatment; adulteration with toxic chemicals, often leading to death or injury; and if a drug contains some active ingredient but too little to kill all the disease agents, it can lead to the emergence of drug resistant strains of disease.

These problems are caused in large part by a combination of defective legal systems and government-imposed distortions of the pharmaceuticals market, say researchers at the International Policy Network:

Poor countries tend to have highly inefficient, slow and expensive legal systems, which makes it very difficult for people to be assured of the quality of the medicines they purchase.

Lack of enforceable trademarks and civil liability are instances of a wider problem; in such an environment, legal decisions tend to be arbitrary and designed to benefit the elite.

Price control measures, like tariffs, on imported medicines are very common in poor countries and drive up the price of high quality medicines creating opportunities for suppliers of fakes, who can then more easily undercut them.

Tariffs can also lead to unnecessary delays in ports, where improper storage conditions can cause drugs degrade.

However, bolstering the rule of law is a long term process in many countries. In the short-term, the private sector should take advantage of its innovative capacity to experiment with various technological solutions that enable it to protect the identity of its products. Governments, meanwhile, should reduce those interventions which undermine the supply of quality drugs, such as taxes, tariffs, price controls and other arbitrary regulations, say researchers.

Source: Julian Harris, Philip Stevens and Julian Morris, "Keeping it Real: Combating the spread of fake drugs in poor," International Policy Network, 2009.

The National Center for Policy Analysis (NCPA) is a nonprofit, nonpartisan public policy research organization, established in 1983. The NCPA's goal is to develop and promote private alternatives to government regulation and control, solving problems by relying on the strength of the competitive, entrepreneurial private sector.

To read the entire piece by Harris, Stevens and Morris, follow the link below:
http://policynetwork.net/uploaded/pdf/keeping_it_real_2009.pdf

Ghana: Food and Drug Board Detects Fake Anti-Malaria Drugs

The Foods and Drugs Board (FDB) this month warned the public of fake cortem tablets, anti-malaria drugs, in the market in Kumasi, Ghana.

The Board has confiscated 150 packs of the product from nine wholesale and retail pharmacies involved in the distribution and sale of the fake products.

Ashanti and Brong Ahafo Zonal Officer of the FDB, Joseph Bennie, said the board has adopted a name-and-shame strategy to fight drug counterfeiting. The following wholesale and retail pharmacies, and licensed chemical sellers were mentioned as distributing the counterfeit Coartem with batch numbers X0089 and M1200:

Wholesale and retail pharmacies included Salom Pharmacy Limited (Kejetia), Habmay Pharmacy Limited (Asafo), Pharmax Ghana Limited, (Bantama), New Tafo), Edikay Pharmacy, (Buokrom Estates), Tracmar Pharmacy (Anwomaso), Fredimens (KO-Ashtown).

The Licensed Chemical Sellers included Martin Owusu Licensed Chemical Seller (Tanoso), Augustine Evans Adu Chemical Shop (Old Tafo).

FDB announced they will soon be handing over to the police the 9 institutions caught trading in counterfeit drugs.

Swine Flu (H1N1 Flu) – Is There Really Cause for Worry?

So consumers want to know about the H1N1 influenza A (otherwise known as Swine Flu) and what does it mean to them? Is it all hype or is this something they should worry about? Well…the best answer is to stay informed, be cautious and be prepared.

Authorities agree that this strain of H1N1 Flu should not be dismissed as a threat just because it has started off as mild cases. This particular flu is genetically a descendant of the Spanish flu of 1918, which started mild, but returned to infect two-thirds of the population and kill over 50 million people. Scientists believe that the current flu will return at the peak of flu season this fall and it will be a stronger more viable foe than the one that stands before us today.

The H1N1 Flu currently has around 6500 confirmed cases in 33 countries globally, of which about 3,400 are in the United States. As to date, most deaths due to this strain have occurred in Mexico. The United States has three confirmed deaths, but those individuals also had underlying health issues that contributed to a more severe case that required hospitalization.

So what about natural immunization? There is very little natural immunity to this strain. There is a possibility that individuals who are in their 90’s and above would be immune since they were most likely exposed to the Spanish Flu. However, the rest of us are probably out of luck.

So what about immunization shots? There are several pharmaceutical companies working on these shots to be delivered in the fall. The problem is that vaccines are developed in hen eggs and take about 4 months for completion. It is unlikely that a mass immunization of the population is feasible and will probably be restricted to those most vulnerable.

So what about medication treatment for those with the flu? This is where the real danger is and consumers need to be cautious. When demand exceeds supply, unscrupulous individuals take advantage of the public. No country has enough flu medication to serve its entire population. Some areas such as UK have enough to accommodate around 80% of their population. This is rare as most do not have enough to cover 50%. Some areas such as California only have enough to cover around 25% of their population.

Beware! Already the public is being spammed with individuals trying to sell Tamiflu over the internet only to steal their credit card information. Expect to see some cases of counterfeit Tamiflu as this was the case when SARS became an issue a few years ago and resulted in counterfeit flu remedies infiltrating the marketplace.

So what can a consumer do to protect themselves? The H1N1 Flu travels the same way as other flues. If you don’t have the flu yet practice good hygiene (i.e. wash your hands frequently; always cover your mouth when you cough) to lessen the spread of the disease to yourself or others. If you think you have the flu, stay home. If you suspect the H1N1 flu see your doctor and get tested. Whatever you do, don’t order medication online except through a known pharmacy. You will need a prescription from your doctor and you should only buy medication through known sources!

For pharmaceutical wholesalers, test your inventories. Pharmacists trust you to give them safe efficient medication to supply the public. Forewarned is forearmed. Be prepared - Get your security procedures in place now to ensure you have the safest medication possible for your distribution chain.

Below are some helpful links for information on the H1N1 Flu:

For General Information and preventative measures visit: http://www.cdc.gov/h1n1flu/qa.htm

To view “How Time and Mutations Engineered the New H1N1 Strain” visit: www.washingtonpost.com.

To view statistics on US confirmed cases by state visit the Center for Disease Control at:www.cdc.gov.

To view statistics on global confirmed cases visit the World Health Organization at: www.who.int.

Khaleej Times: No Country Immune to Menace of Counterfeit Medicines

The following story from the Khaleej Times Online, outlines the overall issue and fight against fake drugs in the UAE. The story in full appears below:

Khaleej Times Online
23 April 2009

DUBAI - Though counterfeit drugs are not readily available in the UAE, they still exist since dealing in fake medicines can be lucrative, say experts.

“In the UAE we don’t see too much, but counterfeit medicines are definitely available. It will always be there. There is big money to be made from dealing in counterfeit medicines and there will always be people who try to exploit this, even if it is at the expense of someone’s life,” he said.

“We are looking at different technologies in the fight against counterfeit medicine,” said Dr Mohammed Abu Elkhair, Head, Pharma/Medicine and Medical Products Regulation Section, Abu Dhabi Health Authority (HAAD).

Providing quality pharmaceutical products to the public is a priority for the health ministries across the region.

“The problem of counterfeit drugs is relevant in the Middle East without being a major cause for concern,” Minister of Health Humaid Mohammed Obaid Al Quttami said while inaugurating the Pharmaceutical and Biotechnology Middle East (PABME) congress and exhibition on Tuesday.

He said the issue is less about fake drugs and more about regulating the market. “Legislation has an important part to play,” he added.

The newly formed Saudi Food and Drug Authority (SFDA) in the Kingdom of Saudi Arabia is also aware of the need to maintain a watch over the trade in counterfeit medicines.

Ibrahim Alshowaier, Consultant, SFDA, indicated that a proactive approach should yield best results.

“Counterfeit drugs are a big problem all over the world. It’s not big in Saudi Arabia, but this doesn’t mean we’re immune from the problem. We’re working closely with pharmaceutical companies, the customs people and the police to tackle this issue and maintain vigilance,” he said.

“We’re actively taking measures to block the traffic of counterfeit drugs. For example, we advise customs and the police about what to specifically look for, and we’ll have SFDA personnel operating at border controls and working with the customs officials there. We see this as preventive, and the best way to proceed, rather than targeting the counterfeits once they’re already here,” he added.

However, the UAE Health Minister placed training in the forefront of developing life sciences, specifically the pharmaceutical industry, in
the country.

“The challenges we face in this area are the quality of the industry, and this includes the quality of our human resources available,” he said.

“The people working in this industry need high levels of training, and I think with training, we need to see international practices adopted that will allow us to see solutions developed.

“The pharmaceutical industry will add value to the health services in the country and the region. The economy will benefit also. By providing access to the right level of training, this will be achieved.”

asmaalizain@khaleejtimes.com

CEO of Hi-Tech Pharmaceuticals sentenced to 4 years for selling Knock-off Drugs

Jared Wheat, the CEO and founder of Hi-Tech Pharmaceuticals was charged $50,000 and sentenced to 50 months in prison for illegally selling prescription drugs online. He distributed fake versions of a variety of medications which included Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra, and Cialis, which he ultimately sold over the Internet without requiring prescriptions.

Hi-Tech Parmaceuticals is located in Georgia and is known for their herbal supplements which are distributed to a variety of American retailers and convenience stores nationwide. Hi-Tech’s most popular products include Stamina-Rx, which it describes as a "maximum sexual stimulant," Lipodrene, "for advanced appetite control and metabolic stimulation," and Metanabol, a "revolutionary catalyst for increasing lean mass and strength.

By accepting a plea bargain, a variety of other charges against him were dropped. These included such charges as racketeering, blackmail and murder conspiracies, and for spiking supplements with ephedrine alkaloids. The U.S. Food and Drug Administration (FDA) banned ephedrine alkaloid use in 2004 after finding that it has potential for dangerous effects on the heart.

Also as part of the plea, said MSNBC, the defendants admitted to operating a manufacturing facility—described as filthy—in Belize in which they produced generic versions of a variety of medications such as Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra, and Cialis, which they ultimately sold over the Internet without requiring prescriptions.

Apparently, reported MSNBC, Wheat conspired to murder an FDA agent and to blackmail a former assistant U.S. attorney general. And, while the allegations were made based on information provided by confidential informants, the charge was dropped in plea bargaining talks.

If the leadership of a national known manufacturer who distributes nationwide could instigate distribution of fake products, how can the public be protected?

It is for this reason that pedigree by itself cannot protect consumers– What needs authenticated is not just WHO it was received from but also WHAT was received! – For this reason, we recommend authentication of the product itself. To find out more on how authentication can protect your supply from adulteration – please visit www.xstreamsystems.net.

Pharmaceutical Returns: The Weak Link in the US Rx Supply Chain

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

As many within domestic regulatory agencies and pharmaceutical industry leaders ponder the battles against counterfeit medications and the many solutions available to combat this global scourge, most have over looked probably the most obvious and weakest link in the overall supply chain, returns.

Pharmaceutical returns, although a small percentage of the overall transactions of the supply chain, account for a significant amount of fraud and counterfeit activities. Most major wholesale pharmaceutical distributors average less than 1% of their monthly gross sales revenues in returns however given the size of their transactions and revenues; this is still a multi-billion dollar weak link that cannot be ignored.

In addition, product transfers within a given distributor, entity or dispenser also are part of this weak link. It is not unusual for a single bottle of pills to be transferred a dozen or more times before a product reaches the dispenser.

Returns are also a necessary component of any supply chain; it is unlikely that restricting the process altogether is a reasonable solution given the enormity of the cost and the thin profit margins of most of the members of the pharmaceutical supply chain.

Most current anti-counterfeiting solutions are capturing the transaction (pedigree) or utilize a sensor based technology on the packaging (RFID) and are totally ineffective in tracking the validity of the product once it has left a secure chain of custody and is returned back into a distributors inventory.

In a time of economic tough times it is far too easy and far too profitable for a pharmaceutical provider or dispenser to fraudulently extract good product, replace all or some of it with inexpensive fillers and then re-seal the bottle. At best a pharmacist can double his profitability on a bottle of pharmaceuticals by replacing good product with harmless fillers, minimally he can re-coup margin lost to unprofitable reimbursement by replacing some pills from a bottle to cover his losses.

Although all pharmaceutical wholesalers require some sort of statement from the provider stating that the product they are returning is the original product that was purchased, sophisticated providers realize that the distributor has very little chance in identifying the adulterated products in its returns as most are tracking hundreds of thousands of bottles that flow through their receiving and returns departments daily. These healthcare professionals must rationalize that their fraud will ultimately be realized in a future transaction by a dispensing pharmacist when they go to fill a prescription and realize that the product in the sealed container is filler and not the actual medication. Even though a pharmacist will be dispensing the medication, it seems likely that too high of a percentage of this fraudulent product will make its way to the consumer and will impact their health adversely.

To date, the majority of the counterfeit materials that XStream’s Authentication solution is discovering at our distributor end users are primarily products that have been fraudulently tampered/adulterated and somehow brought back into the pharmaceutical supply chain inventory via a return goods or transfer process.

XStream encourages all within the pharmaceutical supply chain to protect their inventories by validating their inventories and using an authentication solution to identify the product. The only way that the pharmaceutical supply chain can protect itself is for its members to authenticate its inventories especially when it is processing returns.

If you are a member of the pharmaceutical supply chain or an end user consumer it is important that you are aware of and insist that the partners that you trade with as it relates to pharmaceuticals utilize an authentication technology to protect their inventories and fill in the holes that potentially will impact your health.

Counterfeit Drugs – The Silent Killer of Our Time?

Don’t do the Crime unless you can do the Time – At least that is how the saying goes. But what kind of deterrent is a relatively short sentence vs. the potential loss of thousands of lives?

Recently Mr. Kevin Xu, a known counterfeiter from China was sentenced for his role in a massive plan to distribute counterfeit drugs here in the United States.

He sold counterfeit drugs to U.S. citizens via the Internet. The income from the sales in the U.S. in 2007 totaled $232,568.

His next step was to make inroads into the legitimate supply chain. In negotiations with undercover agents he thought were potential buyers, he listed 25 drugs he could manufacture. These medications included Tamiflu, Plavix, Zyprexa, Aricept and Casodex. What’s more, the samples he provided to “the buyers” looked identical to the real pills.

His plan was ultimately foiled by the undercover agents from U.S. Immigration and Customs Enforcement (ICE) and U.S. Food and Drug Administration(FDA).

In their investigation, agents also learned that Xu distributed counterfeit pharmaceuticals in the United Kingdom which had penetrated the legitimate supply chain in London, and prompted a massive recall for Zyprexa, Plavix and Casodex by the Medicines Health and Regulatory Agency in London, England.

Xu received more than $1.5 million from selling counterfeit pharmaceuticals globally in 2007 alone, yet his sentence was only 6 ½ years!

Fake Drugs More Deadly than Terrorism?

Since 911, we are well familiar with the deadly effects of terrorism, but are you aware there is another danger lurking that has silently killed hundreds of thousands of individuals worldwide?

I am speaking of counterfeit medications, which have been a growing problem in underdeveloped countries for years and are now showing a steep increase in developed countries as well.

According to The Observer, British intelligence has found that criminal gangs (mostly out of China) have shifted away from selling “lifestyle” drugs like Viagra and have switch to “life-saving” medications. These drugs have infiltrated the regular supply chain in Britain and are threatening the health of millions of their citizens.

In fact more the ₤3M of these fake “life-saving” medications for ailments such as heart disease and cancer were seized in the first 10 months of 2008. Some of these medications were found within the official healthcare supply chain. These included Zyprexa, 40,000 doses of Casodex, a hormone treatment for men with advanced prostate cancer, and Plavix, a blood thinner.

Graham Satchwell, the former head of Scotland Yard’s organized crime group believes a significant number of patients may have died already, but it has not been attributed to counterfeit drugs. “They may have less of the active ingredient, meaning people could die because they are not receiving their life-saving treatment. Even now, though, healthcare professionals never assume it is the drug. No one asks whether deaths are attributable to fake medicines,” said Satchwell.

Interpol recently revealed it is investigating reports that profits received from counterfeiting activities are being used to fund terrorist groups such as al-Qaida. And these profits can be huge – as much as ₤1M for the shipment that successfully penetrates into the normal supply chain.


These criminals prey on the most vulnerable: “The counterfeiters target the weakest members of our societies – the young, the sick, the economically disadvantaged, and it is our obligation to take action,” said Ronald Noble, Interpol’s secretary-general.

While the European commission is considering several anti-counterfeiting methods, most are tied to the packaging rather than the drug itself. History has shown that such deterrents such as holograms are only temporary solutions as they themselves are usually copied within a few months. What is needed is verification of the drug itself – such authentication would act as a firewall to make the legitimate supply chain immune from threats.

Will the FDA’s China Office Protect US Consumers?

The Washington Post, New York Times, Bloomberg News and a variety of other media outlets all have stories today announcing the Food and Drug Administration (FDA) deploying staff and opening its first office in Beijing, China.

This is the FDA’s reaction to China’s increasing role as a major exporter to the United States in food, drug and consumer products. Unfortunately China is also the world leader in exporting counterfeit, adulterated and contaminated products and the FDA is attempting to slow down the dangerous impact to US consumers. Recent high profile examples of counterfeit, adulterated and contaminated products include the recent heparin contamination which resulted in over 250 deaths in the US, the pet food contamination with melamine and the huge issue over lead paint on children’s toys. Most experts agree that these examples of toxic products within our consumer supply chain represent only a fraction of the dangerous products that are reaching our shores on a daily basis.

Apparently the FDA has plans this year to open up other offices throughout China and certify third-party inspectors who can approve and qualify the safety of exports to the United States.

The question is when will the FDA deploy a materials analysis technology that can look inside product packaging to inspect and protect the US consumer instead of throwing bodies at a high expense to attempt to catch the problem before it gets into our supply chain?

Stay tuned, we at XStream Systems are trying our best to introduce our revolutionary technology as a solution to catching the problem before it impacts our nations health.

Pharmaceutical Regulatory News Headlines - Week of October 31, 2008

In the United States, Halloween is the day for Tricks and Treats. But - Globally regulatory authorities have Penalties not Treats for would be counterfeiters.

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. Global regulatory authorities are now recognizing the increasing threat these fraudulent products place on their citizens and are taking legal actions to discourage it:

Saudi Arabia: Local Markets Flooded with Counterfeit Drugs
Agreements were made on Tuesday to step up legal action against counterfeiters in Saudi Arabia to ensure consumer safety. According to Abdullah Al-Abdelgader, a pharmaceutical manufacturing director, counterfeit drugs account for around 30-40 percent of medicines sold at local pharmacies and hospitals in Saudi Arabia and expose consumers to great risk. In the Gulf area, the counterfeiting economy accounts for $13 billion, with a share of $4 billion in the Saudi market. ("Some 30-40% of Medicines Sold Locally 'Are Counterfeit', Says Manufacturer," Saudi Gazette, October 22, 2008)

FDA Oversight of Foreign Drugs Lacking
The Food and Drug Administration is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections, according to a report by the Government Accountability Office. The House Energy and Commerce Committee introduced a bill that would mandate foreign inspections at a rate close to that of FDA inspections of U.S. plants. U.S. companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years. ("FDA Is Faulted for Oversight of Foreign Drugs," Wall Street Journal, October 21, 2008)

Nigeria: Government Takes Steps to Block Counterfeit Drugs
The National Agency for Food and Drugs Administration and Control (NAFDAC) has blocked 22 Indian pharmaceutical companies from importing and distributing drugs in Nigeria. The agency has outlawed the use of about 40 imported drugs in the country, describing them as potentially dangerous for human consumption. As part of its efforts to curb drug counterfeits, NAFDAC is advocating for greater public education and awareness. ("Fake Drugs: NAFDAC Bans 22 Indian Firms," AllAfrica.com, October 22, 2008)

XStream Systems thinks that its penetrating authentication technology can be an integral part of the comprehensive solution to this global problem.