Criminals around the world have found that they can maximize gain with relatively little capital outlay through product fraud. It could be pharmaceuticals, baby formula, toothpaste, brake pads, or toys. The more fraud that we allow to take place, the more patients will be put at risk for counterfeit medicines, or, the more chance that your children (or grand-children) will have toxic lead paint on their toys. The problem goes beyond violation of intellectual property rights. Counterfeiting is not a victimless crime. People die each day from unsafe counterfeited items. The problem is as old as mankind.

Early currency was plainly labeled “To Counterfeit Is Death”. The example below is a 4 Pound Note issued by Pennsylvania in 1777.

The theory behind such harsh punishments was that one who had the skills to counterfeit currency was considered a threat to the safety of the state, and had to be eliminated. Far more fortunate was an earlier practitioner of the same art, active in the time of the Emperor Justinian (527 A.D., mosaic shown below), who got the nickname “Alexander The Barber”. Rather than executing the counterfeiter when he was caught, the Emperor decided to employ his financial talents in the government’s own service.

Modern U.S. Currency has changed many times over the past few years:

With the exception of the one-dollar bill (above), all of these notes are obsolete. This is because the United States Government “Mixes & Rotates” (M&R) its overt and covert techniques to stay one step ahead of the counterfeiters. Shown below are examples of anti-counterfeiting “layered levels” of the “ever-changing” “face” of U.S. notes. You will notice the different colors when compared to the notes that are now obsolete:

Overt and Covert M&R (Mix And Rotate) anti-counterfeiting measures include fine detail with raised intaglio printing on bills. This allows non-experts to easily spot forgeries. As a side note, on coins, milled or reeded (marked with parallel grooves) edges are used to show that none of the valuable metal has been scraped off. This detects the shaving or clipping (paring off) of the rim of the coin. However, this does not detect sweating, or shaking coins in a bag and collecting the resulting dust. Since this technique removes a smaller amount, it is primarily used on the most valuable coins, such as gold.

For paper bills, in the late twentieth century advances in computer and photocopy technology made it possible for people without sophisticated training to easily copy currency. To combat this, national engraving bureaus began to include new (more sophisticated) anti-counterfeiting systems such as holograms, multi-colored bills, embedded devices such as strips, microprinting, and inks whose colors change depending on the angle of the light. New technology also includes the use of design features such as the “Eurion Constellation” which disables modern photocopiers.

This is very similar in concept to the “Canada Green” overprint on the U.S. 1862 note (used almost 150 years ago). The tint made it very difficult to photograph (complete story and photo are in the President’s Corner dated October 6th, 2008).

To protect your intellectual property, ATL recommends that you educate yourself about overt and covert anti-counterfeiting (anti-piracy) technologies. We also recommend that you take a long look in the mirror. You, as a brand owner, have the power to do the right things. You have the power to protect the public against diversion, dillution, and counterfeiting. By taking these extra steps you will find out something very surprising in the journey – you, in all likelihood, will be saving money in the process.

Bill Cosby said it best: “A word to the wise ain’t necessary – it’s the stupid ones that need the advice.”

Question. Do I have to notify FDA before I start to use covert markings or materials in my labels?

Answer. The current labeling requirements for pharmaceuticals are part of 21 CFR Parts 210 and 211 – Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General and Current Good Manufacturing Practice For Finished Pharmaceuticals. These are the cGMP’s (Current Good Manufacturing Practices).

The cGMP’s deal mainly with overt labeling features. These include, but are not limited to:
Written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products. These written procedures must be followed. These procedures incorporate the following features:
(a) Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products.
(b) Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container.
(c) Identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch.
(d) Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record.
(e) Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records.

As for pharmaceuticals and tamper-evident packaging: Each manufacturer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale must package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture).

The term “distinctive by design” means the packaging cannot be duplicated with commonly available materials or through commonly available processes.

Photos Below: “Distinctive By Design” examples from August 13, 1776. This New York ten dollar bill had a distinctive pattern on the back. Please note the penalty that was printed on the bill: “Tis Death To Counterfeit”.

A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature must be designed to and must remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

Covert features lack the standardization that you would find in cGMP’s. To my knowledge, the FDA supports covert features, but there are no standards that are mandated. This is why “The International Organization of Standardization” (ISO) has approved the creation of a new Technical Committee (TC) on fraud countermeasures and controls to help address development of standards related to combating fraud. The TC, proposed by the American National Standards Institute (ANSI) in conjunction with the North American Security Products Organization (NASPO), focuses on the development of standards in the areas of brand and intellectual property protection, identity management, and financial fraud.

The proposal, identified as ISO/TS/P 206, hopes to bring together fraud experts, law enforcement, government agencies, criminologists, brand owners, and solution providers to develop relevant security standards for the use of private industries and governments worldwide. ISO recognition and support from other international standards organizations will help to counter the rising financial and social cost of worldwide fraud activity.
The new committee provides a framework to engage international fraud experts with existing ISO technical committees to create solutions to complex issues. Standards will affect parties concerned with brand protection, intellectual property, drug counterfeiting, supply chains for products of value, authentication of goods, food supply chains, identity credentials, identity management, identity theft, customs and immigration enforcement, and financial fraud. Although the scope may appear broad, it effectively addresses the wide variety of fraud throughout industry segments.

So, for now, the FDA is concerned with 21 CFR 210 and 211. These standards do not encompass covert features.

Notable & Quotable: “Your true value depends entirely on what you are compared with.” — Bob Wells

We would like to give you a glimpse of the counterfeit drug issues as they exist today. The simple fact is that your life may be at risk, or the life of someone close to you. As you read of the startling facts, please look for the words “ATL Security Note”. At this juncture we will recommend a solution that will inhibit (or eliminate) the counterfeiters ability to provide you (the public) with fake or diluted medicines.

Photo Above: Illicit drugs that were gathered during a law enforcement raid.

Counterfeit Medications – History

First documented cases of counterfeit medicines date back to 4th century BC. For more than 2,000 years, issue of fraudulent production of medicines has mostly been ignored.
Today it is multi-billion-dollar worldwide trade. Fake drugs are estimated to lead directly to the deaths of more than 500,000 people a year across the globe.

WHO (World Health Organization)

Definition of a Counterfeit Medicine

“A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with fake packaging.”

Counterfeit Medications

The illicit business is worth $18 billion. It is estimated that it will double in the next two years. It represents about 10% of all pharmaceutical sales worldwide.
30% of medicines in Russia and some countries in Africa, Asia and Latin America are counterfeit. In wealthy nations this figure is approximately three percent.
In the United States this equates to eight million packs of medicines worth approximately $975 million a year.
Approximately 25% of all emails – 15 billion messages a day – are spam advertising drugs. 50% of medicines offered by websites that conceal their physical addresses are fakes. Counterfeited, diverted, and diluted medications make more illicit money than cocaine and heroin.
In 2005, more than 500,000 single doses of fake medicines were discovered across Europe. In 2006 this number had shot up to 2.5 million. Only because fake drugs have spread from local markets to more global outlets, aided by the rise of the internet, has the world recognized the magnitude of the problem.

Photo Above: This machine is manufacturing fake drugs.

WHO & IMPACT

In February 2006, WHO created first global partnership known as International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). It is made up of all 193 WHO Member States on voluntary basis. The goal is to improve coordination and harmonization across and between countries so eventually production, trading and selling of fake medicines will cease.

IMPACT focuses on following key areas:
Looks at existing laws in countries.
Provides effective models countries can use.
Develops set of principles for establishment of appropriate legislation and penal sanctions.
Coordinates action at local levels between health authorities, police, customs, and judiciary institutions to ensure proper regulation, control, investigation and prosecution.
Helps countries with weak regulatory systems to strengthen them.
Comprised of five working groups to combat the spread of counterfeits:
- legislative and regulatory infrastructure
- regulatory implementation
- enforcement
- technology
- communication

The United States and Fake Medicines

The US is a lucrative market for counterfeiters of medicines and medical devices. This is because of high prices, a large market, widespread internet connectivity, and complex supply chain. Counterfeits are not normally manufactured in US. They are distributed through online pharmacies, most of which are outside the United States.

50% of medicines sourced from websites that conceal their physical address are counterfeit. These websites advertise and supply medicines illegally, with no prescriptions.
The fake drugs are discovered in the regulated supply chain, through licensed wholesalers, parallel traders, and pharmacies.

Thus, counterfeit medicines reach patients necessitating batch recalls. Fake medicines found in US regulated supply chain are designed to deceive pharmacists and patients into believing that they are genuine. Often only laboratory analysis reveals counterfeit product.

ATL Security Note: the need for lab analysis can be reduced by the use of a mixed and rotated “layered” security approach in labels and packaging. Invisible forensic digital markers can authenticate the product as genuine from virtually anywhere in the world.

Counterfeit medicines discovered in US typically contain reduced amount of active
pharmaceutical ingredient, or wrong ingredient, or no ingredient.

All counterfeit medicines are dangerous.

There are also reports of counterfeit medical devices discovered in US, or seized on their way to US.
Drug counterfeiting occurs less frequently in the US due to strict regulatory framework that governs production of drug products and distribution chain, and enforcement against violators.
The FDA works to ensure overall quality of drug products that consumers purchase from US pharmacies remains high.
The FDA advises pharmacists, physicians, and other healthcare professionals on drugs most likely to be counterfeited and how to identify them.

A suspect patient may have received counterfeit drug if:
He has unexplained worsening of medical condition or unexpected side effect.
He reports drug tastes or looks different, tablets chipped or cracked.
He experiences unusual burning at injection site.

Photo Above: Are you willing to keep taking drugs that are not authenticated as genuine? Will you do this until “death do you part?”

The Internet

Online pharmacies offer benefits of convenience, privacy, and (often) cheaper prices.
Many online pharmacies appear reputable and similar to legitimate retail pharmacy websites BUT sell fake pills that:
- do not contain medicine approved by regulators.
- have doses that are too strong or too weak.
- contain dangerous ingredients.
- aren’t manufactured using safe standards.
- aren’t labelled, packaged or shipped properly.
- are out of date.

Online pharmacies flourish because the public cannot get many new medicines for cancer, dementia, or influenza from publicly funded services. Many sites connected to other sites and have multiple links making investigation difficult. There are jurisdictional challenges as regulatory and enforcement issues cross international lines. The system is difficult to regulate – but governments can do more to warn public of the dangers.

India

India accounts for approximately one-third of counterfeit (fake, diverted, or diluted) drugs.
The EC claims India largest source of 2.7 million counterfeit drugs was seized by its customs in 2006.
India is the number one source of counterfeit medicines, followed by UAE and China.
India’s existing regulations pose little deterrence to unscrupulous drug vendors.

India is to introduce the death penalty for sale and manufacture of fake and counterfeit medicines that cause grievous harm. The minimum prison sentence is to be increased from five to ten years. There will be higher fines for those convicted for trading in fake drugs.

Drug regulatory officials are often in collusion with manufacturers of fake medicines.
It is against the law to sell fake drugs for domestic use, but no regulatory requirements apply to India’s export market.
Common fake drugs are antibiotics, drugs for tuberculosis, malaria, and cough syrups, as well as ingredients for lifestyle drugs.
Exportation of Active Pharmaceutical Ingredient (API) plays integral role in the manufacture of counterfeit medicines.

ATL Security Note: the use of a mixed and rotated “layered” security approach in labels and packaging works just the same when protecting the public for the purity of API (Active Pharmaceutical Ingredients). Invisible forensic digital markers, color-shifting inks, and other covert features can protect the public by ensuring the API are genuine. This is commonly known as maintaining the “pedigree”.

During first six months in 2005, more than 250kg of sildenafil citrate, Viagra’s active ingredient, were exported from India to Europe. Out of one kilogram sildenafil citrate, approximately 14,000 tablets of counterfeit Viagra-pills can be produced. If sold at normal market price of genuine Viagra a profit of up to 2,000% could result.

Photo Above: Real and fake drugs, side by side. Which would you take?

China

In China, between 200,000 and 300,000 people are estimated to die each year because of counterfeit or substandard medicines. The current baby formula incidents are a sad reminder of the human pain and suffering.

China has 80,000 chemical companies, and the FDA does not know how many sell ingredients used in drugs consumed by Americans. China exports “drug ingredients” to customers in 150 countries.

China’s State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies.
Corruption and lack of protection for whistleblowers undermines China’s attempt to establish a more rigorous drug regulatory system.

In 2007, a series of scandals involving counterfeit pharmaceutical exports led to intense international pressure on the Chinese government. This resulted in conviction and subsequent sentencing to death of the country’s two top drug regulators for accepting bribes.
Some counterfeiters have the same equipment used by pharmaceutical companies.
Cases have occurred of pharmaceutical laboratories that manufacture genuine drugs during business hours and produce counterfeits at night.
Counterfeiters have set up companies that provide service of disposing of expired medicines, thus they obtain real expired medicines that they repack and re-label.

ATL Security Note. Repackaging and relabeling (as described above) could be detected if an invisible forensic code was used in security packaging for the pharmaceuticals. If this covert technique was used, the break in the pedigree could be discovered before the consumer is harmed.

Photo Above: Fake hologram (left), and genuine hologram (right).

ATL Security Note. The following is a portion of the FDA’s conclusions from 2006: “The FDA’s vision of a safe and secure prescription drug supply chain is based on transparency and accountability by all persons who handle the prescription drug throughout the supply chain. With the implementation of the pedigree regulations in December 2006, the FDA expects that supply chain stakeholders will move quickly to adopt electronic track and trace technology, implementing RFID or an alternative track and trace technology in a phased-in approach. Although there are important issues that still need resolution, these issues should not hinder the forward progress and momentum toward widespread adoption. In the meantime, the FDA believes that public health would be better protected if all stakeholders work cooperatively to enable all distributors to pass pedigrees.”

The 2006 Report also considered several technical issues related to adoption of electronic track and trace technology that were perceived as obstacles to implementation and are in need of resolution. These include:
Mass serialization and unique identification of each drug package; and Universal pedigree with national uniform information.

As a brand owner ATL believes that you can protect the public by maintaining a record containing information regarding each transaction that results in a change of ownership of a given drug or pharmaceutical ingredient. This includes its sale by the manufacturer, through the wholesalers, distributors, and pharmacies.
As a brand owner, ATL can work with you to develop:

Lot or batch codes;
Integrated Mass Serialization;
2D DataMatrix Codes;
Forensic (invisible, non-degradable, nano-molecular markers);
Many other covert techniques.

In the 1950’s, when W. Edwards Deming tried to teach U.S. Manufactures about statistical quality control, he was not listened to. At the time, the stigmas of the past (as well as arrogance and ignorance) lived within the powerful decision makers in this country. Dr. Deming went on to huge success in Japan. He believed in quality before it was a buzzword.

“We are here to make another world.” W. Edwards Deming

Photo Above: W. Edwards Deming.

I believe that U.S. pharmaceutical manufacturers (and other brand owners) must protect the public from harm by providing safety and security for the genuine purity of their products. The citizens of the world must demand this.

“We must not inhibit our forward thinking by the comfort levels of the past. If something is not working, you must fix it, repair it, or invent a new paradigm. If you don’t, how many people are you willing to harm for the sake of a few dollars?” Donald J. Dobert, President, ATL.

Above: Two Beatles albums from the “Capitol” days. Did you know there were thousands of counterfeit Beatles albums before Capitol (B.C.)?

I came across an absolutely fascinating article written by Frank Daniels in 2002. It was all about “The Beatles” early albums B.C. (Before Capitol). As I read this I wondered: “If counterfeiters will go through these extreme measures to flood the market with fake records, then I had better be very careful when buying medicines or safety related items.” Here are parts of Mr. Daniels writings:
Fakes and Fantasies
A counterfeit or fake record is one that attempts to pass itself off as a genuine record that was actually issued by a legitimate record company at one time. Sometimes, counterfeits do not look exactly like the genuine copies that they mimic but are slightly different. A fantasy record or sleeve is one that pretends to be a rare and otherwise unknown item. However, no legitimate record company ever pressed or printed an item like that one.

A pirate copy of a record is a counterfeit that is made while the legitimate record is still selling. These lower quality “knock-offs” are intended to dupe people into buying them at a lower price than the genuine record album would cost. While Vee Jay and Swan (Record Companies) were still producing Beatles records, there was certainly no need for anyone to make “pirate,” “counterfeit,” or “fantasy” records on those labels. However, during the late 1960’s demand arose for Beatles records on those two labels. Counterfeiters filled that void, making counterfeit copies of “Introducing the Beatles” and of the Swan “She Loves You” single. The 1970’s and ’80’s saw even more counterfeits being circulated. Since there were no legitimate copies selling, these counterfeits are — strictly speaking — NOT “pirate” copies, even though they were not being sold as “collectors’ items.”

“She Loves You”/”I’ll Get You” – (Counterfeit) Swan 4152: white label with red print or black label with silver print.

It has been believed for some time that “thin print” copies with quotation marks were reissues available in 1966 and 1967 (just before Swan Records folded in 1967). These rumors are false, for Swan had a contract to release the single for two years and stopped pressing “She Loves You” in 1965. There are two common issues of these fakes: (1) The matrix numbers are stamped into the trail-off by machine. Unlike the genuine Swan issues, the matrix numbers are only 1/16″ high, and neither the “Reco-Art” nor “Virtue Studio” company information appears in the matrix. (2) The matrix numbers are etched by hand, otherwise as above.

The “stamped matrix” fakes have been promoted as reissues. Even though these fakes are almost as common as the ‘black label’ issues and are not genuine, public opinion for years that they were genuine has caused them to sell for $40 to $50 each. The “etched matrix” fakes have been recognized as counterfeits and usually sell for under $10.
Some counterfeit/fantasy copies of the white and red label “She Loves You” were pressed in red vinyl. These tend to sell for about $20, twice as much as the more common black vinyl counterfeits.

“Please Please Me” – “Ask Me Why” – (Fantasy) Vee Jay 498 sleeves: Since the Beatles were complete unknowns in the USA in early 1963, Vee Jay Records never issued a picture sleeve for their first release. Bootleggers have filled the void by producing fantasy sleeves. Each of the above sleeves first appeared after 1980. The first sleeve, shown above, features an early photo of the group. Like the actual single, the sleeve misspells “Beatles,” using two T’s. There are promotional markings on the reverse side, as though the sleeve had accompanied original white/gray label promo copies. In reality, the sleeve came about 20 years too late.

The second sleeve sports four drawings of the Beatles that Vee Jay actually did produce. These are the drawings that appear inside “Songs, Pictures, and Stories”. On this fantasy sleeve, the brackets logo was used, even though Vee Jay hadn’t come up with it in early 1963. The group’s name is also spelled correctly.

“From Me to You” – “Thank You Girl” – (Fantasy) Vee Jay 522 sleeves. As with the above single, there were no original picture sleeves accompanying the Beatles’ second single for Vee Jay. Bootleggers have produced at least two fantasy sleeves for the record. Again, both sleeves are of recent origin. The first sleeve is a pale imitation of the genuine sleeve to Vee Jay 581, with the photograph flipped around. The second sleeve uses the photo from the 1982 re-release of “Love Me Do.” This second-generation picture is blurry.

“Please Please Me” – “From Me to You” -(Counterfeit) Vee Jay 581 sleeves. The first of these sleeves is actually a counterfeit/fantasy item, not intended to fool someone but to simply occupy the missing place of a rare item in someone’s collection. The sleeve is clearly unlike the genuine sleeve, for the group’s name appears here in green (above photo, top) and in red on the original sleeve. The sleeve on the bottom is a different matter! Look at the top (opening) of the sleeve. Genuine copies of the VJ 581 sleeve have the slick cut so that the corners at the top are slightly rounded; copies that have the corners cut square are counterfeits.

Clearly Counterfeit Covers
Let’s first look at some fakes that are clearly identifiable just from the cover:

The cover is ugly and yellowed. The photograph is clearly a second-generation copy. The word “STEREO” is printed on the front cover (since the counterfeiters did not actually own a stereo cover). These fakes date to the late 1960’s.

Below: Here’s another “easy loser.” There are no genuine copies of the LP with a brown border around the album. Most likely, these were semi-fantasy items that were never intended to pass themselves off as genuine. Since they first appeared in the mid-to-late 1970’s, some people have forgotten that they are fakes.

Clearly Counterfeit Labels
The vast majority of counterfeit copies of “Introducing the Beatles” cannot be easily identified by their covers alone. Chances are, though, if it claims to be in stereo and claims to have “Love Me Do” in the titles on the back, it’s a phony. The best test to determine whether your item is genuine is to look at the symbols that are stamped into the matrix of the record. Since this can be difficult — even confusing for some — we’ll take the next best route: to look at the labels.

Above: This is an all black label with large brackets. These were first introduced in the late 1970’s, along with fakes of “Songs, Pictures, and Stories” and “Hear the Beatles Tell All”. The label is of higher quality than some of the “rainbow label” fakes, but since the artist name and title are separated by the spindle hole, it’s a clear fake. Also, during the 1960’s, Vee Jay never released a “large brackets” version of an “all black label.” Finally, these usually come in covers claiming that the record is in stereo; the label does not say “STEREO” — another sign of a counterfeit. Some “all black” counterfeit labels from the same period list “Ask Me Why” and “Please Please Me” — since the counterfeiters did not own copies that had “Love Me Do” and “PS I Love You” on them.

Above: This style counterfeit label was very popular — some copies date back to the 60’s. Notice the thin print on the catalog number. Like the other fakes, the mono catalog number is shown on the label; the bootleggers did not have stereo copies to copy from. That’s why the songs are in mono, too. Here, we see again the telltale sign — that the word “STEREO” is absent, and the title and artist name are separated by the spindle hole. Either one of these is the sign of a fake.

Above: By the late 1970’s, some copies of the same style fake as the one above were being made sloppily. Notice that the label is not the right size. Part of the color band is missing around the label’s edge. Otherwise, it exhibits the same counterfeit characteristics as the label above.

Above: This counterfeit, from the early 1980’s, looks slightly better. The colors in the color band are more realistic. However, the word “STEREO” is still missing, and the cover this record came with claimed it was in stereo. It’s also got the title and artist’s name separated. Another fake.

Above: Here’s another fake, again slightly more professional looking. This one came out during the mid 1980’s. Once again, though, we have a brackets label copy without “STEREO” (and the cover promised us stereo). And even more clearly, the title and artist’s name are separated by the spindle hole in the middle. A disappointing effort.

Above: This counterfeit was color photocopied from a genuine MONO copy of the LP, so the title and artist’s name are in the right place. The colors are strange, but it would fool most people. It came in a “stereo” cover, though, so again something is wrong. Notice that the color green is missing from the label. The record also lists “Please Please Me” and “Ask Me Why,” since that’s the kind of genuine copy that was being photocopied. The label also has a large pressing ring, a kind not found on genuine 1964 releases.

Fast Forward To 2008

Many thanks go to Mr. Frank Daniels for his highly interesting work on different Beatles counterfeits. As he pointed in 2002, counterfeiters were running wild when a buck was to be made. Today, why would you risk buying prescription medicines and “genuine” OEM auto parts that cannot be authenticated as “the real goods”?

If you are a brand owner, it doesn’t cost much to secure packaging and provide consumers with labeling that has “layered” overt and covert anti-counterfeiting protection.

If you are a consumer, we encourage you to ask manufacturers what they are doing to protect you from purchasing counterfeited goods. After all, if there are “hundreds” of Beatles counterfeits, it is logical to assume that there are thousands of chances that you are purchasing “fake”, “illicit”, “diverted”, or “diluted” prescription medications. Fight back. Insist on brand protection.

It’s time to take bold leadership and protect the public. Mark Twain said it best: “Keep away from people who try to belittle your ambitions. Small people always do that, but the really great make you feel that you, too, can become great, and your ideas have merit.”