36 Million Americans Have Bought Rx’s From Illegal Online Pharmacies

Tens of millions of Americans have bought medications online without a prescription, according to a new study.


Alaric DeArment in Drug Store News writes about a study funded by the Alliance for Save Online Pharmacies and released by The Partnership at DrugFree.org, which finds that illegal online pharmacies have sold drugs to 36 million Americans.

According to the Drug Store News story:

• Many independent and chain retail pharmacies operate websites and there also are reputable online pharmacies, such as Drugstore.com. However, a number of illegal online pharmacies also exist, and buying drugs from them opens consumers to the risk of taking counterfeit, adulterated or unapproved medications.

• “Those who sell prescription drugs online without a valid prescription are operating illegally, undercutting the laws that were put in place to protect patients, and are thereby endangering the public health,” U.S. intellectual property enforcement coordinator Victoria Espinel said. “It is a real wake-up call that so many Americans have engaged in this dangerous behavior.”

• At the White House Intellectual Property Health and Safety Forum on Tuesday, Espinel said 11 companies had joined to create a nonprofit group designed to target illegal online pharmacies, including American Express, Visa, MasterCard, PayPal, eNom, Google, Microsoft, Neustar, Network Solutions, Yahoo! and Go Daddy.

The purchase of drugs from illegal online sites is a dangerous practice that impacts the health and safety of entire consumer populations.

With these illegal purchases, the consumer is potentially bringing dangerous fakes into the legitimate supply chain. It is critical that all members of the legitimate pharmaceutical supply chain take measures to protect themselves from these dangerous sources of supply.

To read the Drug Store News story, visit: http://www.drugstorenews.com/article/companies-band-together-end-illegal-online-pharmacies

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

Chinese SFDA Official Arrested in Rabies Vaccine Scandal

In an online story, written by Phil Taylor in Securing Pharma, the Chinese newspaper 21st Century Business Herald is reporting that an official with the SDFA, the Chinese State Food and Drug Administration has been arrested in connection with an investigation into the adulteration of rabies vaccine.

Wei Liang an official with SFDA's Drug Registration Department has been charged with taking nearly $145,000 in bribes.

The arrest is related to the adulteration and substitution of raw materials used in the manufacturing of thousands of doses of rabies vaccines at a vaccine manufacturing plant operated by Jiangsu Ealong Biotech Co.

According to SFDA officials the adulterated vaccines will not provide the appropriate protection against the disease but are unlikely to cause adverse effects.

SDFA’s have investigated another rabies vaccine-producing company - Hebei Bioforwell Co - but have to find any evidence of criminal activity.

The entire investigation was precipitated by the December 2009 discovery by the SFDA that more than 215,000 doses of rabies vaccine supplied by the Jiangsu Ealong Biotech and Hebei Bioforwell had quality problems.

The SDFA is concerned that some of the adulterated and sub-potent vaccine may still be in the Chinese supply chain.

This particular healthcare scandal apparently contains the gamut of premeditated fraud, raw material adulteration, medication quality control issues, official bribery and official corruption all at the expense of the health of the Chinese population.

This incident, much like the Heparin scandal that cost thousands of lives several years ago, should encourage all members of the pharmaceutical supply chain to authenticate and verify medications within their control to avoid liability, protect their business brand and make certain that the healthcare consumer is protected from potentially deadly consequences of fraudulent, adulterated or counterfeit drugs.

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

To read the Securing Pharma online story, visit: http://www.securingpharma.com/.

Medical High Jacking: Polish Police Recover 11 Tons of Stolen Plasma

Polish police announced that they have recovered 11 tons of human blood plasma that had been stolen from the U.S. Company BioLife Plasma Services, a collection facility owned by Baxter International. The plasma was on its way to Austria, officials said Thursday.

The stolen Blood Plasma was worth more than euro1 million ($1.4 million), and was taken while the driver made a rest stop in Germany.

The plasma was recovered in its original boxes originating from Harrisonburg, Virginia, where BioLife Plasma Services, has operations.

BioLife spokeswoman Laura Jacobs said the plasma had come from other facilities as well, but did not elaborate.

Jacobs said the company was working with local authorities to determine how the theft occurred. "Importantly, the plasma has been recovered and is currently in Baxter's Vienna facility," she said.

Plasma is a critical component used in the treatment of a wide range of medical procedures. Given that the product was stolen and has lost its official chain of custody it remains to be seen if all of the Blood Plasma would need to be destroyed due to potential issues of contamination and adulteration.

This particular incident, based on stolen but critical medical supplies, energizes the need for routine material screening of products within the supply chain, from manufacturing to dispensing, to properly protect consumers from fraud, adulteration, contamination and counterfeiting.

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

WHO: Poor Quality Drugs Used to Treat Malaria

Both the BBC and the Associated Press are reporting on a new World Health Organization study regarding the quality of drugs used to treat malaria in Africa.

The study goes into some depth regarding the findings that up to 40% of the artemisinin drugs used to treat malaria in poor African nations are of such poor quality they are ineffective in treating the disease. In addition because these poor quality drugs contain some of the active ingredient of the drugs, they are now causing drug resistant strains of malaria.

Here are some of the highlights from the BBC story:

• The group, conducting the study for the World Health Organization, said low-grade drugs were being used in both public and private health practices.



• Some 90% of malaria deaths in the world occur in Africa.



• They found 44% of the drugs from Senegal failed the testing, followed by 30% from Madagascar and 26% from Uganda.

To read the entire BBC story, visit: http://news.bbc.co.uk/2/hi/africa/8504137.stm

Some of the highlights of the Associate Press story which was published in the Chicago Tribune include:

• Between 16 percent and 40 percent of artemisinin-based drugs sold in Senegal, Madagascar and Uganda failed quality testing, including having impurities or not containing enough active ingredients, the survey found.


• Artemisinin-based drugs are the only affordable treatment for malaria left in the global medicine cabinet. Other drugs have already lost effectiveness due to resistance, which builds when not enough medicine is taken to kill all of the mosquito-transmitted parasites.



• If artemisinin-based drugs stop working, there is no good replacement and experts worry many people could die.


• "It is worrisome that almost all of the poor-quality data that was obtained was a result of inadequate amounts of active (ingredients) or the presence of impurities in the product," said Patrick Lukulay, director of a nongovernmental U.S. Pharmacopeia program funded by the U.S. government, which conducted the survey. "This is a disturbing trend that came to light."


• The study is the first part of a 10-country examination of anti-malarials in Africa by the U.S. and the World Health Organization. It follows evidence from the Thai-Cambodian border that artemisinin-based drugs there are taking longer to cure malaria patients, the first sign of drug resistance.


• The three-country report also found bad drugs in both the public and private health sectors, meaning governments — some buying medicines with donor funds — are not doing enough to keep poor-quality pills out. All of the drugs tested from the public sector in Uganda, however, passed the quality tests. But 40 percent of the artemisinin-based drugs in Senegal failed.


• "There are countries where donated medicines are not subjected to quality controls, they're just accepted," said Lukulay. "There are countries in Africa where Chinese products have been donated and found to be unacceptable later in the public sector."

To read the entire Associated Press story, visit: http://www.chicagotribune.com/health/sns-ap-med-africa-malaria-drugs,0,1354782.story.

This issue of counterfeit, fraudulent and adulterated medications, which is causing a deadly healthcare crisis around the globe, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers everywhere.

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

USP Develops New Testing to Identify Deadly adulterants for Two Pharmaceutical Ingredients

The U.S. Pharmacopeial Convention (USP) this week announced revised standards for two ingredients widely used in pharmaceuticals as sweetening agents and solvents.

USP is a nonprofit, scientific organization that sets legally recognized standards designating the identity, quality, purity, strength and consistency of prescription and over-the-counter medications and their ingredients in the United States. These standards are enforced by the U.S. Food and Drug Administration (FDA).

The revisions respond to a request from FDA to revise the USP Propylene Glycol and Sorbitol Solution standards to include limits for diethylene glycol (DEG) to help prevent future episodes of pharmaceutical adulterations with this poisonous chemical. DEG is commonly used in antifreeze and has no legitimate place in medicines.

DEG historically has been substituted for Glycerin with deadly results.
Adulterations of cough syrups and other products with DEG have occurred many times and in many countries, including a tragic episode between November 2008 and January 2009 in which 84 children in Nigeria died after ingesting teething syrup contaminated with DEG. A similar episode occurred in July 2009 in Bangladesh, killing at least 24 children.

To view the press release from USP visit: http://www.eurekalert.org/pub_releases/2009-10/up-ntf103009.php

For more information, visit www.usp.org/hottopics/propyleneGlycolSorbitolInformation.html or email mediarelations@usp.org.

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.

Zanola to Remain Free Pending the "Medicine Mafia" trial

Recent events in Argentina have shocked citizens as those in the power to protect their health have been implicated in the "Medicine Mafia" scandal where top leaders are accussed of distributing counterfeit, aduterated,and expired medications for life threatening diseases. Here is one of the latest developments in the case from Buenos Aires Herald:

Federal Judge Norberto Oyarbide authorized Bank Clerks' union leader Juan José Zanola to remain free pending a trial in which he is charged with adultering medicines.

Zanola will have to pay three million and and his girlfriend Paula Aballay, a million pesos bail money for that freedom.

According to Federal Judge Norberto Oyarbide, Zanola would have been "highly compromised" in the purchase of the adulterated medicine from San Javier pharmaceuticals for the Bank Clerks' health centre. The pharma company is owned by businessman Néstor Lorenzo, currently in prison. San Javier manufactured drugs for cancer and aids patients.

To view entire article visit: www.buenosairesherald.com.

Doctor of Pharmacology Dies from Counterfeit Medication

In a sad and incredibly ironic story, a 29 year old with a doctorate in physiology and pharmacology, died recently after injecting herself with substandard buprenorphine. Buprenorphine, a drug used to treat addiction, had been purchased by the victim from an online pharmacy based in the Philippines.

Carrie John of Baltimore, a post graduate research fellow at the University Of Maryland School Of Medicine, died September 27 after diluting the drug in water from its original pill format and injecting the drug. John earlier this year co-authored and published a study on her research of "compulsions and habit formation”.

Buprenorphine is a narcotic known on the street as "bupe" and commonly used to treat heroin addiction. The woman and her boyfriend, also a post graduate researcher, apparently have been purchasing various narcotics for recreational use for the past two or three years from New Mikee Online Pharmacy, a Web site pharmaceutcal supplier based in the Philippines.

According to the boyfriend the couple used the pharmacy to buy not only buprenorphine but morphine, OxyContin and marijuana.

This terrible story is a cautionary tale to all about the evils of drug addiction and the real life danger of counterfeit, adulterated and fraudulent drugs. When a highly educated, pharmaceutical professional falls victim to both addiction and fraudulent drugs bought online, it begs the question as to what kind of risk average consumers face when drugs that are purchased online find their way into the legitimate drug supply.

To read the entire story, which appeared in the Baltimore Sun, follow the link:
http://www.baltimoresun.com/news/maryland/baltimore-city/bal-md.overdose30sep30,0,1002971.story

Associated Press: FDA Announces Plans to Improve Public Announcements on Food, Drug Safety

The Associated Press on September 30, 2009 reported, "The Food and Drug Administration is laying out plans to improve its public announcements on food and drug safety, more than three years after federal advisers recommended major changes." The agency "will begin studying public response to its announcements on potentially dangerous food and drugs."

Given the recent proliferation of counterfeit, adulterated, fraudulent and production issues on medications and consumer products produced and distributed in the United States, this is announcement is seen as an important step forward in protecting the domestic consumer.

The Limitations of Track and Trace Technologies in Fighting Counterfeit Drugs

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

To date, nearly all of the solutions for the global epidemic of counterfeit and adulterated drugs has emphasized technologies that are known as Track and Trace methods (e.g. barcodes, holograms, RFID, pedigree, taggants, and serialization).

Track and Trace methods were developed and are based on technology designed for inventory control/security and are common within most sophisticated supply chains. These solutions are very effective in tracking product, 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.

That being said, Track and Trace solutions have their limitations:

• They generally require some sort of an addition to the outside of the box or package and a common technology to be read and documented.


• These processes and technologies add additional cost to the product and are difficult to maintain across large global supply chains.


• Because of its external placement of these methods on the material’s packaging, the Track and Trace item may be easily replicated, and, at the very least, does not verify that the material inside the package is safe and efficacious.

The costs for a global supply chain to implement Track and Trace solutions are staggering. According to an EU Commission Consultant, the initial cost for deploying a Mass Serialization pharmaceutical program in the European Union would include:

• An industry wide one-time cost of €11.5 billion to set up the proper systems within all members of the pharmaceutical supply chain in Europe.


• Annual “running costs” for serialization with European pharmaceutical companies to be €185.5 million for non-OTC companies.


• EU pharmacies would incur costs of installing the right IT and reading devices to support serialization estimated to be approximately €157 million, with no estimates on the annual costs of running the system.

Although Track and Trace solutions are useful to a point, they are significantly limited in their effectiveness. When additional costs to all members of the supply chain are added, they include significant changes to the manufacturing, packaging and distribution processes. Additionally, as we have seen lately, many of the incidents of substandard, fraudulent and counterfeit product all had perfect pedigrees and their packaging was either original or perfect facsimiles.

The best way to effectively purge the pharmaceutical supply chain of poor quality, fraudulent or counterfeit medications is to look inside the box to screen, verify and authenticate the product inside the package.

Ideally, a quality control and anti-counterfeit solution for the pharmaceutical supply chain would not require any alterations to the product or the package. The remedy would allow packaged drugs to remain intact and will be readily deployable. The placement of the testing unit could be at strategic points within the supply chain or deployed throughout without onerous costs or prohibitive timelines.
This new cure would provide a level of confidence that public safety is ensured by verifying the material inside the package.

We at XStream Systems are very excited about our technology which meets the needs as an effective quality control and anti-counterfeit technology solution for the pharmaceutical supply chain. The XT250 system allows the members of the pharmaceutical supply chain to screen and verify the contents of product inside its unit of sale container without opening it, changing its label, or destroying or degrading the material inside.

To learn more about XStream’s XT250 and its revolutionary technology, visit: http://www.xstreamsystems.net/.

Bangladesh: Tainted pain reliever kills 25 children

An Industrial solvent was added to a popular over-the-counter pain reliever rendering it toxic. It is estimate that the tainted paracetamol syrup is responsible for killing over 25 children in Bangladesh. Tests revealed that diethylene glycol was substituted for propylene glycol in the formula.

Diethylene glycol is often used as a solvent for dyes and resins. It is also used as a coolant, a substance found in antifreeze. Diethylene glycol is often illegally used as counterfeit glycerin in some nations and sold internationally as a component of cough syrup, toothpaste, and mouthwash because it is less expense than the legitimate ingredient. However, because it is toxic, this often leads to disastrous results.

In Bangladesh, twenty-five children age 1 to 5 have died in the past six weeks. According to authorities, the tainted medicine killed most if not all of the children. Most of the deaths have been reported in the district of Comilla, where the factory is. The plant has since been shut down.

Last year in the United States, two New Yorkers, Saifoulaye Diallo and Habib Bah, pleaded guilty to importing counterfeit Colgate toothpaste tainted with Diethylene glycol. In their testimony they admitted to buying the Chinese toothpaste and repacking it to look like the Colgate brand, but were unaware that the toothpaste itself was toxic. The packaging of the counterfeit toothpaste was mostly indistinguishable from real Colgate, although the wording did contain some spelling and grammatical errors. Additionally, the toothpaste was identified as being made in South Africa, in an effort to avoid scrutiny from customs officials.

These individuals and various additional importers of the tainted Chinese toothpaste sold under different brands popular at dollar stores and state institutions (such as prisons). The imports accounted for over a million tubes of counterfeit toothpaste distributed in the U.S. throughout several states between 2007 – 2008.

This along with other recent examples of substandard medications, emphasize the need to have molecular pharmaceutical authentication along the supply chain route to protect consumer sagainst toxic substitutions. To view more on molecular authentication, visit www.xstreamsystems.net.

Bi-Annual Cargo Theft Report: Value of Pharmaceutical Cargo Theft Has Skyrocketed in the First Half of 2009

FreightWatch International (USA), an international logistics security company, whose expertise is in identifying threats and vulnerabilities to high-value supply and distribution chains, publishes a Bi-Annual Cargo Theft Report that contains some very interesting statistics and observations.

The Bi-Annual Cargo Theft Report is available on-line and outlines statistics and vulnerabilities of various supply chains, specifically reporting on pharmaceutical cargo theft incidents.

As you read through the Cargo Theft Report it is striking how sophisticated and prevalent cargo theft has become. Additionally as it relates to the domestic pharmaceutical supply chain it is illuminating on how cargo theft can impact the amount of fraudulent, counterfeit and adulterated medications within our medication supply.

The following are some striking statistics from January to June 2009 as it relates to the pharmaceutical cargo theft incidents:

• The first six months of 2009 has seen a decrease in cargo theft incidents involving pharmaceuticals from 25 reported incidents in 2008 to 14 incidents in 2009. However, the total value of pharmaceutical products lost as a result of cargo theft has skyrocketed in the first half of 2009.


• From January to June 2009 over $73,000,000 in pharmaceutical products has been stolen. One loss was valued at $37 million, which was subsequently recovered, however, not after the chain of custody was broken for a short period of time.


• The average pharmaceutical loss for the first six months in 2009 is $6,712,500 per theft, a tremendous increase from 2008’s six month average of $704,685 per theft.

Both in 2008 and 2009, the vast majority of pharmaceutical thefts occurred on the East and South Eastern U.S., particularly along major interstate highways as well as in Florida.

The statistics and relevance of this Report supports XStream Systems’ assertion that it is important that pharmaceutical inventories be screened through a level of material verification that is available via our XT250 and its revolutionary EDXRD technology. This exciting technology allows the XT250 to authenticate pharmaceuticals inside their unit of sale containers without destroying or degrading the medication inside.

With so many millions lost each month in cargo theft and presumably re-introduced into the supply chain at various points, it is critical that the provider and consumer are assured that the medications they are taking are safe and effective.

To learn more about FreightWatch’s services or to view the entire Bi-Annual Cargo Theft Report January-June 2009, visit their website at www.freightwatchusa.com.

Hi-Tech Pharmaceuticals Recalls Sexual Performance Supplement

The Food and Drug Administration (FDA) has ordered Hi Tech Pharmaceuticals to recall their sexual performance Supplement Stamina-Rx after it was discovered to contain an undeclared ingredient, benzamidenafil. The ingredient is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Since the recall is due to an undeclared ingredient and Hi-Tech Pharmaceuticals is under a Consent Decree of Permanent Injunction with FDA since September 23, 2003, FDA has ordered a recall of all lots to the consumer level. Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088].

Canary in the Coal Mine; Why Everyone Should Be Concerned Over the Death of Polo Ponies in Florida

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

Back in the days before high tech ventilation and gas detectors, one of coal mining’s earliest tools for detecting dangerous levels of methane gas in a mine shaft was a canary. Basically if the bird died, miners had to get out the shaft, quickly.

In a tragic 21st century adaptation of this low tech scenario, last Sunday in Florida, 21 polo ponies died from what is being initially reported as injections believed to be of a steroid derivative potentially contaminated with a toxin. Details are still sketchy and forensic tests are being conducted but this was not a random or unfortunate mistake of spoiled feed or un-potable water, but likely an unintentional mass poisoning at the hands of trained animal healthcare professionals through medications.

According to published reports, apparently prior to the incident, shots were injected by a Team Veterinarian and are suspected to be the cause of this toxic reaction and heart failure in these horses. It is still not clear as to why and for what purpose the horses were receiving the injection.

Bear in mind that these horses are some of the most pampered equines on the planet. Their diet and exercise are closely monitored and regulated by their very demanding owners. Most polo ponies live and receive a higher level of care than 95% of the world’s human population. Their average value is well over $100,000 each, which make this a $2.1m tragedy presumably caused by contaminated product that was thought to enhance their health and performance.

Why is this important to humans? Much like the miners of long ago, we humans are basically sharing the medications literally and figuratively that are used on animals. Although not specifically shared, most of the raw materials and basic production of our medications are identical or the same. Similarly the value and supply chain of medications share many commonalities. Basically, if the high priced pampered pets of the rich can receive contaminated pharmaceuticals, so will humans.

Just like the heparin contamination that caused over 250 deaths in the United States last year, we should take heed of this equine tragedy and realize that our safety is in peril. The drugs that we consume must be protected and analyzed within their supply chain so that we have a level of confidence in the products we are taking to make us or keep us healthy. Not unlike the miners of the 21st century, it is time to protect ourselves with modern technology instead of relying on a canary or in this case a polo pony to keep us safe.

Tainted Drugs Kill 21 Horses in Florida

(Details Developing)

Various news sources, including the South Florida Sun Sentinel, are reporting that as many as 21 horses have died after receiving injections of a drug from an Argentine Veterinarian. It is believed that shots from the veterinarian, who is not licensed in the United States, may have been tainted with some sort of toxic agent.

The horses, or pedigreed polo ponies, belonged to a single Venezuelan team competing in the U.S. Open Polo Tournament at the Palm Beach Polo Club in Wellington, Florida. Each of the horses is estimated to be valued in excess of $100,000.

Fourteen of the horses collapsed on the polo grounds before the start of their scheduled match and seven others died at or while in route to an equine animal hospital several hours later. Efforts to treat the horses at the polo grounds and the hospital were unsuccessful.

The story and details are still developing but Florida officials are conducting necropsies and blood analysis on the animals to determine what specifically caused their death.

It still remains to be determined if the drugs that were injected were legal in the US, where they came from and the source of contamination of the drug.

This tragedy seems to be a harbinger of concern as it relates to medication and product safety for both animals and humans in the United States. The issue of counterfeit, adulterated and tainted medications worldwide continue to kill and injure hundreds of thousands of people and animals annually and now appears to be poised to significantly impact the population here in the United States. There is little distinction between human and animal medications as it relates to the production of pharmaceuticals, any issue that impacts one group of consumers will ultimate impact the other.

XStream believes that materials analysis of all medications within the supply chain (production, distribution and dispensing) is vital as it relates protecting all health care consumers from counterfeit, adulterated and contaminated medications.

Ahead of the Curve

Charles R. Earl, M.A., ABD
CEO, Communication Connections

The major portion of our discussions on these pages has focused on the impact of counterfeiting and adulteration on patient safety and supply chain reliability. This is where the primary consideration should be, but there are other important factors in play, too. Much of the recent news coverage has chronicled the challenges facing the national … and global economies. Corporations and businesses everywhere are belt-tightening, downsizing or closing. Some businesses will thrive in this environment by becoming leaner and more efficient while others will enter “panic mode” and never fully recover from these trying times.

From my experience as a business manager and as a corporate and business trainer, I have had the opportunity to witness how truly successful leaders cope with difficult circumstances. Although the “right now” requires intensely concentrated effort and resources, successful leaders never fail to look ahead to tomorrow. They do not abdicate their duties for visionary thinking and acting. They race ahead of the curve.

It is difficult for a corporate officer or manager to justify purchasing new technology when the market is uncharacteristically tough. Concentration is directed to monthly P&L’s, quarterly statements, and annual reports. Every nickel that can be saved and every penny pinched become important for day-to-day operations. “No major expenditures” and “no new commitments” become the rallying cries for weathering the economic storm. Count the pens! Inventory the paper clips! Use both sides of the printer paper! I could go on, but you get the idea.

While the market, the governments, customers and patients are clamoring for safer and more reliable pharmaceutical delivery, you cannot afford to retreat into a posture of preservation. You, as a leader, who wants to guide a leading company of the industry must seize the initiative. The old reliable aphorism “if you’re not moving forward, then you’re falling backward” is still true. Offer more for your customers—better service and safer product.

Imagine this scenario: A customer calls your office and asks you to submit an RFIP. This company is impressed with your innovative efforts to supply safe, trustworthy products as well as your obvious commitment to top-rate customer service. Another customer calls your competitor, and the receptionist responds,” I’m sorry, he can’t come to the phone right now. He’s in the supply closet counting paperclips.”

XStream Systems Stories and News for the Week of November 21, 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. As counterfeits become more prevalent globally and domestically, science will play a strong role in protecting our nation’s supply chain and molecular pharmaceutical authentication will be an important part of solving this global problem:

Israel joins world effort to halt counterfeit drug sales
Inspectors went to the Tel Aviv package warehouse of the Israel Postal Company and other facilities last week, seizing drugs prohibited in Israel and others suspected of being counterfeit that had been shipped from India and China.

FDA: FDA Hosts Its First Science Writers Symposium
Recently FDA experts met with more than 50 journalists and science writers at the FDA’s first Science Writers Symposium. At this day-long event, FDA’s scientists and physicians presented on such research as the science behind the Salmonella outbreaks, melamine adulteration of food substances, and nutrigenomics – an emerging field that has the potential to prevent disease and maximize health by using genetic profiles to tailor what we eat. FDA experts also presented their novel discoveries to prevent pandemic flu, identify contaminated heparin, and analyze the safety of drug-eluting stents down to the molecular level.

FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.

Daschle Accepts HHS Cabinet Post
Former Senate Majority Leader Tom Daschle has accepted President-elect Barack Obama's offer to be Secretary of Health and Human Services.