Counterfeit Drugs More Deadly Than Terrorism

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

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

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/.

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.

LA Times: Growth of Counterfeit Drugs Sparks International Response

As reported in the November 21 addition of the Los Angeles Times, authorities in the U.S. and across the globe conduct raids this week to intercept fake medications. Highlights from the story appear below:

New York - In highly orchestrated raids around the world this week, Interpol officers in Europe, drug agents in the United States and task forces from Sweden to Singapore confiscated counterfeit prescription drugs in an attempt to stem a rapidly growing criminal business that preys on financially pressed consumers looking for bargains.

The operation, code-named Pangea, is an effort to fight back against fraudulent prescription drug businesses, which have become a $28-million industry in the United States alone.

The national crackdown uncovered nearly 800 packages of fake or suspicious prescription drugs, including Viagra, Vicodin, and Claritin, and shut down 68 rogue online pharmacies, authorities said. They said some counterfeit drugs may have as much as three times more of an active ingredient than is typically prescribed; others may be placebos. Drywall material, antifreeze and yellow highway paint have been found in counterfeit pills.

The operation is centered in a sprawling mail center at New York's Kennedy Airport where hundreds of packages of suspected fake medicines were dumped into orange bins, piled on skids and stacked high waiting to be examined by agents from numerous government agencies. Overseas, Interpol officers and task forces stormed suspected counterfeit drug warehouses and distribution centers.

Counterfeit drugs are the latest -- and potentially most dangerous -- front in the long-running battle against intellectual-property crimes. Law enforcement officials said consumers typically think of counterfeited products such as fake Louis Vuitton purses or Nike sneakers. Although shoes are the most common phony product, accounting for 38%, or $102 million, of counterfeit products seized by customs officials last year, pharmaceuticals are one of the fastest-growing categories.

In 2007, they made up about 6% of total seizures. Last year, they accounted for 10% to become the third-largest category, with an estimated market value of $28 million. Federal officials say that trend is particularly disturbing because of the health dangers that such drugs present.


Counterfeit drugs have a history as old as snake oil, and now the high cost of many prescription drugs has driven consumers to hunt for cheaper alternatives on the Internet. According to the National Assn. of Chain Drug Stores, a trade group, Americans spent $254 billion on prescription drugs last year, up 1.8% from 2007. The long-running recession has made such costs more difficult for many consumers to bear, experts said.

The National Assn. of Boards of Pharmacy maintains a list of roughly 4,000 online pharmacies it says are questionable.

In New York, federal agents spent the week at Kennedy Airport pulling suspicious packages from China, India, Peru, Pakistan, Brazil, Turkey, Taiwan and Russia, trying to spot distribution trends and gathering leads. The leads can take months or years to track down, but officials said they needed to start somewhere.

"For the criminals, at least, we're telling them that everybody's looking," said Richard Halverson, unit chief at the National Intellectual Property Rights Coordination Center.

To see the entire story that appeared in the Los Angeles Times, visit: http://www.latimes.com/business/la-fi-counterfeit21-2009nov21,0,274882.story

20,000 or more Patients Receive Adulterated Prescriptions in “Medicine Mafia” Scheme

As the investigation proceeds in the “Medicine Mafia” Story, officials are just getting a glimpse of the extent of the problem. Authorities are uncovering well-entrenched criminal organizations going back maybe 5 years. At least seven large unions are involved in the scheme and up to fifty unions are under investigation.

Most of the substances in question were for life saving medications for cancer, HIV/AIDS, genetic disorders, and hemophilia. Suspects are accused of distributing expired, diluted, and fake medications.

Argentina’s Superintendent of Health Services estimated that a minimum of 20,000 patients received the illegal pharmaceuticals.


To view more information on counterfeit drugs, read the International Federation of Pharmaceutical Manufacturers and Associations (IFRMA) document on “Counterfeit Medicine: The Global Public Health Risks” at: www.ifpma.org.

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

We All Need To Be On The Lookout for Fake Anti-Viral Medications and Vaccines

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

As the United States slowly moves into the traditional flu season, it bears repeating to be on the lookout for scams regarding fake vaccines and anti-viral medications. These fake drugs seem to proliferating within the legitimate global pharmaceutical supply chain as we speak.

Anti-viral medications like Tamiflu and Relenza are being used worldwide to treat and lessen the impact of the H1N1 flu epidemic (formally known as the Swine Flu) and we are expecting shortly a flu vaccine for the H1N1 virus.

As stated before and predicted here on Secure Pharma Chain Blog, it would soon follow that unscrupulous counterfeiters would seize the opportunity of the epidemic and flood the market with counterfeit, adulterated and sub potent knock offs of these important medications. Unfortunately our predictions were right on target.

Those within the Southern Hemisphere, who are in the grip of flu season can attest, counterfeiters are attempting to flood the market with these dangerous knock offs and the impact of these fakes may impact more than just those who take the bogus medications.

A new dangerous consequence has emerged in this fight against H1N1 and counterfeit drugs.

Many global healthcare officials are now concerned that some counterfeit or knock off vaccines/ anti-viral medications could contain some of the active ingredients of the legitimate medications used in the fight against this epidemic and build drug resistant strains of the H1N1.

Much like what is seen in third world with Malaria, some counterfeiters use just enough active ingredients in their knock off drug to fool rudimentary screening tools but not enough for any therapeutic value against the disease.

The insidious practice of partially active ingredients in fake drugs adds injury to insult. It essentially creates super strains of a disease that resist the drugs used against them. This means that we all suffer the consequence of counterfeit drugs not just the unfortunate suckers who bought and consumed them. Because of counterfeit medications we may now all face a super charged H1N1 virus with limited medications to protect ourselves.

As it relates to the H1N1 epidemic, we all need to be on the lookout for counterfeit vaccines and anti-viral medications, here are a few tips to keep in mind:

• Only buy anti-viral medications with a prescription from your physician and from a licensed, established local or chain pharmacy in your area.


• Only get vaccinations from licensed, established local healthcare providers.


• Make certain that your pharmacy only buys product from reliable wholesalers and distributors that utilize transactional pedigrees and use some sort of verification process to screen their inventories.


• Never buy anti-viral medications or vaccines on-line from unknown vendors that do not require a prescription from your physician.


• Never buy anti-viral medications on-line from international sources or from sites that are not accredited by the National Association of Boards of Pharmacy.


• Always remember, if it sounds to good to be true, it probably is…

As this epidemic runs its course over the next several months or years, it is especially important for us all to be on the lookout for fake medications.

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

Using Scientific Tools in an International War on Fake Drugs

The July 20th edition of the New York Times published an excellent article written by Thomas Fuller about using mass spectrometers and other forensic laboratory technologies to identify and interdict fraudulent and counterfeit medications.

The article is an excellent source of information on counterfeit drugs and the efforts to use authentication technology as an effective tool in finding and securing international pharmaceutical supply chain.

Laboratory instruments are an excellent resource in gaining granular and exact information on suspect materials and fake medications.

XStream’s XT250 Material Identification solution like these laboratory technologies has proven to be an effective tool in identifying fake medication but has been developed to be deployed within the supply chain and used by a non-technical resource for instant and exact information on suspected product. The XT250 does not require the destruction of the material and allows the testing of the material inside its sealed unit-of-sale container so that material found to be good can remain in the supply chain and go onto the consumer. To find out more about XStream’s revolutionary technology visit our website at www.xstreamsystems.net.

XStream endorses all technologies used in the fight against counterfeit drugs because we realize that there is no one solution to protect the vital health care supply chain.
To read the Thomas Fuller’s article please follow the link:

http://www.nytimes.com/2009/07/21/science/21coun.htl?pagewanted=1&_r=1&emc=eta1

Why We Need A Suite of Solutions To Secure the Pharmaceutical Supply Chain — Now!

By: Alan Clock, Senior Vice President, XStream Systems

Gary Noon the CEO of Aegate, argues the case for mass serialization in an editorial titled “Why We Need Mass Serialization – Now!” which appeared in the June issue of Pharmacy Technology Europe. In this article, Noon explains why point of dispensing drug authentication is not only a guarantee of medicine integrity, but also a beneficial and cost-effective solution for the pharmaceutical industry.


Noon cites many compelling statistics in his piece, most of these are statistics are centered on the European medication supply chain but their points are global:

• Approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year — in other words; one pack in every 20,000 is counterfeit.
• Between now and 2020, the spread of counterfeit drugs is estimated to rise to either an 'optimistic' 19.5 million or a pessimistic 192 million packs in the legal supply chain.

Noon also correctly points out the danger of products that hit the legitimate market and the costs:

• In 2005, 2,500 packets of fake Lipitor, Pfizer's widely used anti-cholesterol medicine, were believed to have entered the UK market. Research by Frost & Sullivan estimates that fewer than 15% of the packs were recovered. Aside from the potential danger to patients this inability to effectively recall drugs poses, the damage to the reputations of individual manufacturers and to the industry as a whole is vast.
• According to the EU Commission consultation on combating counterfeiting medicines for human use, released in December 2008, the annual direct and indirect societal costs of counterfeiting are approximately €950 million. The overall costs of inaction will reach €9.5 billion–€116 billion by 2020, and this does not take into account the intangible yet significant damage to brand reputation and trust.

After Noon points out the compelling need for a solution, he leaps to the assumption that the only solution for this problem is via mass serialization of the supply chain. Basically he asserts that only a complex serialization solution from manufacturer to dispenser, which according to the an EU Commission consultant would result in staggering set up and annual costs across the supply chain, is the best and only way to secure the Pharmaceutical Supply Chain:

• An industry wide one- time cost of €11.5 billion to set up the proper systems within all members of the supply chain in Europe alone.
• Annual “running costs” for serialization with European companies to be €185.5 million for non-OTC companies. There were no estimates of costs associated to OTC companies.
• EU pharmacies would incur costs of installing the right IT and reading devices to support serialization estimated to be €157 million. Noon offered no estimates on the annual costs of running this the system.

We at XStream take a different view, frankly it doesn’t matter with what currency or market that you are serializing, Euros or Dollars, the costs are astronomical, very unrealistic given the current global economic malaise and the solution is so complex to implement it is very unlikely to impact the problem. Additionally it doesn't seem a stretch to make the point that the estimated costs are overly optimistic and and he is only referencing Europe.

What Noon does not factor in or discuss in this piece are the basic realities necessary to make serialization work:

• Mass serialization requires that each member of the supply chain be perfectly in synch, every link in the chain and each company has to be in a virtual daisy chain process to make it work.
• Each member's system and technology has to work seamlessly to process and communicate the serialization throughout the chain.
• Although Noon makes this serialization synchonization sound simple and seemingly downplays the costs, practically it would prove to be nearly as impossible to globally integrate and effective as herding cats.

In any industry there is little hope that an entire supply chain could be efficiently managed, globally integrated and synchronized across the spectrum without significant effort and coordination. Mass serialization would require massive regulatory mandates, huge cost overruns in the billions (Euros and Dollars) and many years of significant legal arm twisting across multiple borders.

Even if, by chance, the supply chain was all properly serialized, integrated, managed and set up, all it would take would be one link failing in this “daisy chain” even temporarily for the entire system to fall apart.

Bottom line one single failure and the multiple billions in Euros or Dollars becomes wasted and the security and efficacy of the product in doubt.

Although we see limited merit in serialization, where we differ from Noon is that we realize, as most who have studied the issue of global pharmaceutical counterfeiting, is that there is no one single technology or solution to the problem.

Even though there is no technology or singular solution that can offer comprehensive protection from raw materials to dispensing and ultimately consumption by the consumer; it is a battle that all within the pharmaceutical supply chain should join in to solve.

Serialization, like other Track and Trace solutions such as RFID, Pedigrees and Bar Codes has its place and uses and we believe can and should be a part of any sophisticated supply chain. But in order to properly protect the supply chain and the consumer comprehensively, a system and process of screening the actual product, not just the transaction or package, is necessary to eliminate fraudulent and counterfeit medications.

In recent memory there have been a variety of fraudulent and counterfeit medications that have passed through the global pharmaceutical supply chain, in most cases nearly all would have passed a pedigree, packaging tag or serial code but their contents impacted the health of those who consumed it.

Analytical screening throughout the process takes away the “daisy chain” effect which mandates and requires participation by all to be effective. By using technology like EDXRD, XStream’s XT250 can screen and validate the medication inside its sealed container, creating an instant pedigree while authenticating the medication inside the package is efficacious.

Screening and authentication technologies do not require complex integrations and can be deployed anywhere within the supply chain to validate the safety of the inventories on hand. Additionally screening solutions, at the point of dispense, can assist providers from averting medication and dispensing errors. The cost of implementing screening solutions would be a fraction of a mass serialization solution and could be deployed almost immediately.

Overall, we are not completely dismissing Mr. Noon’s point as it relates to the need for a solution; we do however take exception to his conclusion that Serialization is the only answer. XStream Systems believes that governments and industry need to deploy a variety of tactics and technology to defeat fraudulent and counterfeit medications and we do not believe that it will requires tens of billions of Euros or Dollars to begin the process. XStream suggests that each member of the supply chain needs to understand their place and responsibility within the chain and deploy the proper tools to secure it so that we can all have faith that the medications we supply and consume are safe.

XStream Systems Stories and News for the Week of October 17, 2008

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. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Study Finds Prescription Drug Packaging Varies In Quality
The quality of prescription drug packaging from leading manufacturers varies considerably, according to a study by Pharmacy Healthcare Solutions Inc. (PHSI), a finding that could affect the integrity of the medications contained in them.

Bush signs anti-counterfeiting bill
President Bush signed a bill creating an intellectual property czar to beef up U.S. enforcement of laws against pirated and counterfeited products, including pharmaceuticals.

New Zealand: Death Highlights Dangers of Ordering Drugs Online
Earlier this year, Graham David Goodwin of Blenheim died after taking drugs that included an anti-depressant he had ordered online and had mailed to him. As a result, Parliament is being urged to crack down on the illegal importation of prescription medicines.

Sex Doctor Sold Dodgy Tablets
Dr George Patino, 48, dubbed the “King of Viagra” was jailed for his part in a multi-million pound fake medicine ring. He sold thousands of counterfeit impotence tablets to customers across the world.