Obama and McCain Both Support Drug Re-Importation

As the 2008 Presidential Campaign heads into its inevitable heated conclusion and the individual campaigns separate themselves on the issues, it may be time to reflect briefly on an issue that both Barrack Obama and John McCain seem to be in agreement.

Both Barrack Obama and John McCain have publically stated their support of drug re-importation as a way to curb the high price of pharmaceuticals.

Given this seemingly rare consensus it is important to realize that there is a significant possibility that drug re-importation may become a reality once the new administration comes into power.

There are certainly many pros and cons to the issue and many reasons why there is significant support for this stance by both candidates. It is important however to understand the considerable danger that re-importation magnifies if it becomes law.

As we all know by now, the issue of counterfeit, adulterated and contaminated drugs has been proliferating both domestically and globally dramatically in recent years. To date the United States has little in the way of regulations or solutions in place to adequately protect the domestic pharmaceutical supply chain from this threat, outside of weak state pedigree laws which attempt to track the transaction of drugs from the manufacturer to the drug store.

If the re-importation of drugs becomes a reality, the potential threat of even more counterfeit, adulterated and contaminated medications reaching the American consumer will automatically triple given the supply chain’s inability to adequately track and authenticate the actual contents of the medication.

This is where XStream Systems technology can save the day. XStream’s XT250 system has the ability to authenticate and verify the contents of a sealed container in a non-destructive manner. Authenticating the contents of the imported pharmaceuticals will be critical in making certain that pharmaceuticals imported from other countries are clinically safe and efficacious.

Please visit XStream Systems website at www.xstreamsystems.net for more information on this technology.

Do counterfeiters have no shame?

Who would target innocent children in the pursuit of money? Fourteen babies have been hospitalized with kidney stones after drinking what is thought to be counterfeit baby formula. This recent scheme seems targeted toward the poorer rural areas of China where young families have turned to discounted milk powder to lower their household costs.

Why did they choose infant formula? – Well, just as in the case of the adulterated heparin, as demand exceeds supply so does the increased risk of susceptibility to counterfeiting. Over the past few years, increases in the cost of raw milk coupled with the decrease of dairy farming have further complicated this matter.

Sanlu, one of the four largest powdered milk companies in China, has stated that the product labeled as theirs is a fake and has sent their own personnel to investigate. This, however, is little consolation to the poor rural families whose babies are now suffering.

This is not the first case of deadly Chinese baby formula. In 2004, thirteen infants died and 170 were left malnutrition and underdeveloped by counterfeit formulas with little or no nutritional value which were sold under 45 different brands and manufactured in over 141 different factories.

The mere expanse of the operation is disheartening and its implications frightening in light of the fact that China is one of the largest exporters in pharmaceutical ingredients to the U.S.

We must fortify our inspection and authentication methods to ensure our brands integrity. Fool me once shame on you …. Fool me twice shame on me.

Track and Trace versus Inspection and Authentication Technologies?

In a comparison of Track and Trace versus Inspection and Authentication technologies it is apparent that Track and Trace solutions such as RFID, bar coding, holograms, tracing and pedigree products are not a one-size-fits-all solution to protecting the domestic and global pharmaceutical supply chain.

Track and Trace products might be sufficient, when employed throughout the Supply Chain to protect it from Drug Diversion which is one source of counterfeit activity, but these Track and Trace technologies cannot provide full protection for the product within the package. For example, how can anyone expect a Track and Trace product to determine if, either in the manufacturing or distribution process, the wrong ingredient was purposely or accidentally added into the product? Pedigree or Serialization may help, after a threat has propagated to the general public and was detected by other means, to help backtrack to the source of the problem. But by then it may be too late and the consumer will have already suffered.…

Only through the use of Inspection and Authentication technology such as XStream Systems’ XT250 Pharmaceutical Authentication System can those within the drug supply chain immediately inspect and authenticate the product within the container. Don’t let problems reach the general public. Stop the issues in their tracks.

For more information on XStream Systems and the XT250™ Pharmaceutical Authentication System, visit their website at www.xstreamsystems.net.

FDA says drug stores sold expired medications

The Medicine Shoppe, a subsidiary of Cardinal Health (one of the “Big Three Distributors”), sold expired or presumed fake prescriptions to their customers. Granted this was just two of their stores located in Baltimore, but it does make one wonder – How did this happen?

Especially troubling is that this may just be the beginning. In Europe, officials are seeing an upward trend of expired product simply being relabeled to appear good. It is estimated that 10% of medicines sold there are counterfeited or adulterated.

The Medicine Shoppe's suspect medications and the conditions they treat include:

• Lisinopril (20 milligrams) _ hypertension
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg) _ cough
• Gabapentin (100 mg, 300 mg and 400 mg) _ epilepsy
• Metoprolol (50 mg) _ hypertension
• Nifedipine (30 mg) _ hypertension
• Diclofenac Sodium (30 mg) _ anti-inflammatory
• Glucophage (500 mg Extended Release) _ diabetes
• Glucovance (125 mg and 500 mg) _ diabetes
• Glipizide/Metformin (2.50 mg/250 mg) _ diabetes
• Furosemide (20 mg) _ diuretic
• Tamoxifen Citrate (10 mg) _ breast cancer
• Metformin HCl ER (500 mg) _ diabetes
• Calcitrol (0.25 micrograms) _ osteoporosis

It has long been assumed that if product was purchased straight from the manufacturer and/or one of the major distributors, that naturally, the medicine was pristine. However, these days that assumption, sadly, is no longer valid. This year alone, we have witnessed recalls from Baxter for adulterated heparin, Ranbaxy for counterfeit HIV medications, and NOW a major drug store chain for fake or expired prescriptions.

To view the full article from Associated Press, click here.


Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Ranbaxy Probed Over Counterfeit Medicine

In an article that appeared in the Washington Times, the Justice Department is investigating whether Ranbaxy Laboratories Ltd., which supplies generic drugs to the U.S. market and to President Bush's global AIDS initiative, has falsified data, followed sub-par manufacturing practices and distributed counterfeit medicine.

The filing stated that "allegations from reliable sources indicate a pattern of systematic fraudulent conduct" by the company. The allegations include that in its application process, the company submitted fabricated data to the Food and Drug Administration for generic drugs to be distributed in the U.S. and anti-retroviral drugs to be distributed in other countries as part of the President's Emergency Plan for AIDS Relief.

This is yet another example of potentially counterfeit product distributed widely in the global pharmaceutical supply chain that would have passed all Track and Trace methods of interdiction. These products have been distributed and consumed because pedigree or tracing processes do not authenticate the medication inside the container.

XStream Systems XT250 would have been able to discover the fraudulent and counterfeit material before they were distributed and dispensed because the technology verifies the molecular structure of the medication inside the sealed container.

To learn more about the XT250, visit our website at www.xstreamsystems.net.

To read more of the Washington Times article click here.

Making a Killing: The Deadly Implications of the Counterfeit Drug Trade

This book written by Roger Bate and published by American Enterprise Institute for Public Policy Research is an excellent encapsulation of the growing danger that is facing consumers globally. In his book Bate masterfully researches the history, scope, globalization, causes and current solutions on the issue of counterfeit pharmaceuticals.

Unfortunately this is an issue that far too few industry and government thought leaders are aware of, adequately educated on or are taking the proper steps to protect their company or constituents against.

Bate recommendations seem to be fixed primarily on dated technologies such as e-pedigrees and RFID as the answer to protecting the drug supply chain. Regrettably he seems unaware of other technologies like XStream Systems' XT250 that can authenticate medications inside a sealed container and which teamed with or in a standalone fashion can properly protect inventories throughout the global and domestic pharmaceutical supply chain. Here’s hoping that as Bate follows up on this well written book, he goes beyond his excellent foundation of the issue and deeper and further in researching potential solutions.

All-in-all, Making a Killing is an excellent book that is a must read for everyone involved in the healthcare industry and the pharmaceutical supply chain.

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.