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

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

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

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

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

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

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

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

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

Will the FDA’s China Office Protect US Consumers?

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

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

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

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

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

Economic Downturn Means Counterfeit Medications Likely to Increase

As the economies around the globe continue to teeter and decline, it seems apparent that those same dynamics will trigger an increase in the criminal enterprises that deal in counterfeit medications.

This next year, we anticipate a sharp increase in reported instances of counterfeit pharmaceuticals discovered within the pharmaceutical supply chain.

“All of the economics drivers that are driving the economy down, give counterfeiters the perfect environment to flourish, “stated Alan Clock, Senior Vice President at XStream Systems. “Consumers and healthcare providers that are looking for cheaper medications often look outside of the secure sources and can easily fall prey to unscrupulous suppliers who may be selling counterfeit or adulterated medications.”

As consumers look for value in purchasing medications, it is important to buy products from established, licensed drug stores. Only buy products on-line that are affiliated with a national chain drug store or licensed pharmacy benefit organization.

Most importantly, remember, if it sounds too good to be true…it probably is. Let the buyer beware, especially when you are buying your medications in a troubled economy.

Schwarzenegger Terminates the Momentum of E-Pedigree in California

In a story reported in Drug Store News, Tuesday, California Governor Arnold Swarzenegger signed a bill which essentially pushes back the deadline for compliance of e-pedigree requirements within the supply chain until 2017.

Given the seriousness of the threat of counterfeit, adulterated and contaminated medications within the US pharmaceutical supply chain it is apparent that manufacturers, distributors and dispensers still need to take precautions to protect their drug inventories.

XStream’s EDXRD technology allows each member to independently protect itself from counterfeit and adulterated medications without an elaborate and expensive process that only tracks the transaction.

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.

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.

What Measures Can Ensure the Integrity of Purchased Pharmaceuticals?

The integrity of our pharmaceutical supply chain is being questioned! Diversion, counterfeited products and adulterated ingredients have left consumers, regulators, and dispensers clamoring for more stringent anti-counterfeiting methods. Furthermore, the recent heparin recalls have emphasized the need for protection not only of the finished product, but also of the raw materials used in the production of medications.

In the May issue of Pharmacy Times, James C. McAllister, a health-systems consultant, addresses the security responsibilities of all players within the supply chain to combat these threats.

Mr. McAllister states, “Solving this dilemma will be challenging. Collaboration of pharmacists, manufacturers, wholesalers, and distributors, as well as regulatory agencies at the state and national level, should begin expeditiously.”

He moves forward to suggest that manufacturers bear all recall costs and financial responsibility for the quality of their drugs. For distributors and manufacturers, he asks that the FDA levy heavy economic sanctions on those selling substandard drugs. His proposal is a wake up call to the risks that are present – Those who risk our health – Risk their wealth.

Which begs the question - How do your anti-counterfeiting methods measure up?

FDA Links 100 Deaths to Heparin Since 2007

Late yesterday, the FDA announced publicly that over 100 patients within the United States have died while taking the blood thinning medication Heparin since January 2007.

The FDA found that over 62 of the deaths are the result of allergic reactions to contaminated batches of Heparin, which is significantly higher than their previous estimate of 19 deaths. Many of these deaths were not reported when they occurred, but are only now being reported to the FDA.

Allergic reactions to heparin are rare with only 3 deaths reported in 2006. However these increased in 2007, jumping dramatically to 8 in November, 12 in December, 16 in January, and 11 in February. FDA has posted the month to month mortality statistics on their website.

The presumed cause of the increased reactions is the adulterated compound the FDA discovered in the recalled products, whose ingredients were imported from China (See: Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin).

China is a major supplier of raw heparin, which is derived from pig intestines. Recent decreases in swine population, due to blue ear disease, have caused Chinese plants to turn to smaller wholesalers for their own supply. Chondroitin-Sulfate is less expensive than its genuine heparin counterpart, which may explain why it was incorporated in the raw heparin.

In answer to this major threat, recalls have expanded to seven countries: U.S., Germany, Japan, Denmark, France, Italy, and Australia. Furthermore, the FDA has upgraded the pharmaceutical testing of imported Heparin.

Where, Oh Where Did My Medicine Come From?

You may think you know where your medicine originated. It came from Pfizer, or Merck, or Bayer, or some other big name pharmaceutical manufacturer. The question is where did they get it?

Many of our modern day medications are complex. They might be synthesized from chemicals or use biological agents and all have some kind of filler, bulking agent, or suspension liquid. So where do all those ingredients come from and why can’t you tell where your medication was made?

Almost 80% of the active ingredients come from overseas and many of the companies that supply the fillers or chemicals are not inspected by the FDA because the product is not considered pharmaceutical. Even to inspect only the active ingredients, the FDA has stated it would take them over 13 years to inspect each plant.

What’s more – pharmaceutical companies are only required to list active ingredients not the raw material or fillers that make up the medicine.

It’s like a giant puzzle; but what if you could zoom out and see the whole picture, match it against the picture on the box and know if something didn’t fit? That might be just around the corner with EDXRD technology. A new product, the XT250 System, uses this technology to build an industry standard of a compound and then use it when comparing a sample. The software will even do the thinking for you to determine if it is or is not a match – no scientific knowledge required. It’s like a pharmaceutical lie detector to stand guard at our gates.

It would give consumers the peace of mind to know “what they see is what they get” because after all, isn’t that what really counts?