Rep. Buyer's Eight Minute Blitz on Counterfeit Drugs

On August 17th Postscript Community Catalyst Kate Petersen blogged about Rep. Steve Buyer’s (R-IN) exchange with FDA officials in July at a Energy and Commerce Subcommittee hearing on antibiotic drug resistance in farm animals.

This blog has the text of the testimony of Rep. Buyer, engaging in some animated exchanges with FDA officials over the state of pharmaceutical counterfeits in the United States.

Rep. Buyer has established for himself a reputation as a watchdog on counterfeit drug issues. In 2008, he joined with Rep. Jim Matheson (D-UT) to introduce the Safeguarding America’s Pharmaceutical Act.

Below are highlights from this portion of the hearing:

Mr. {Pallone.} Next is the gentleman from Indiana, who has 8 minutes. Mr. Buyer.

Mr. {Buyer.} Thank you very much. Dr. Clifford, I have a question that deals with adulterated, counterfeit, knockoff drugs. We have a problem in our country, and countries around the world are challenged by this. Do you see any escalation or any evidence of adulterated counterfeit drugs in animal health?

Dr. {Clifford.} Congressman, since this really falls under FDA’s jurisdiction, I would have to turn to them to answer that question.…

Dr. {Sharfstein.} For animal health, I think we are going to have to get back to you. I am not prepared to answer that. I have not heard of a significant counterfeit problem in the United States but I want to make sure and get back to you.

Mr. {Buyer.} You know, as our problem is growing, it is only time before it migrates. It is going to follow the money, right? Bad guys follow the money. And that is why I asked the question.
I want to thank the FDA for continuing the blitzes that you are doing at international mail facilities, so thank you for doing that. You are trying to “get the word out” to Americans that if you go on the Internet and you think that that is an approved website to order your pharmaceutical products, that you are really playing Russian roulette with your life, and so thank you for keeping these blitzes going and trying to get the word out. I noted in your testimony when you were with us in March, you had in your testimony, “Protecting Americans from unsafe or contaminated drugs is not just an important responsibility of the FDA, it is our core charge.” Do you agree with that today?

Dr. {Sharfstein.} I do believe that. I think it is one of the reasons that FDA—

Mr. {Buyer.} So–

Dr. {Sharfstein.} –was established.

Mr. {Buyer.} You also then in your testimony talked about FDA must adopt a new approach. Now, I think when you talked about your new approach, also you were concerned about the production, i.e., raw ingredients, that are used within our supply chain for which people are buying at retail outlets within the gold standard of our own country. So ensuring that we maintain that gold standard, you are putting your eyes on that supply chain and production. I don’t have any problems with that. I think that is wonderful. I think the Administration is doing what it is supposed to do. I applaud you with regard to your striking the agreements with other countries, putting more inspections on other soils. That is awesome.

…Now, as we are doing this, we have got both of these going on at the same time, is we are trying to then do our electronic pedigree, and Mr. Dingell has a bill, and we are going to do work and do this electronic pedigree, but let me tell you what I was bothered about what I read in the Miami Dade about your last blitz. I think it is great. Like I said, you are doing the blitz. You did a 3-day blitz. You did everything you were supposed to do, your coordination with Customs, Border Protection, thousands of pieces of foreign mail. You X-rayed them. You separated them. You identified them, the suspicious pharmaceutical products. You ID’d them. You showed how many of them were counterfeit and knocked off, and then you sent them back.

America has to be shocked, and the counterfeiters have to be excited that America is a place where you can counterfeit your drugs, send them to America, steal people’s money, and the American government will send the counterfeit drugs back to you so you can then send them to someone else that you can steal more money from. This is like one of the dumbest policies I think we have in this country…

I know you have got to be uncomfortable with that as a policy. Are you?

Dr. {Sharfstein.} Yes. I mean, I have spoken to some of the inspectors who are, you know, as frustrated as you are.

Mr. {Buyer.} All right. Now, if you are willing to step into a new–and that was your testimony that you gave to us in March, that you embrace and wanted to adopt a new approach with regard to the raw ingredients, through production and distribution always to U.S. consumers, I think I have an opportunity. I think, Mr. Dingell, we have an opportunity to help protect America, and that is embrace what the FDA is saying here, Mr. Dingell, and let us figure out how we can destroy these when they are identified, when your inspectors identify them. Let us not send them back to the counterfeiters so they can continue to rip off people. You know, Doc, come on, they are preying upon the most vulnerable of our population, which is awful. Would you be willing to work with Mr. Dingell and I to come up with a policy here that can give your inspectors the ability to destroy these counterfeit, knockoff, adulterated drugs?

Dr. {Sharfstein.} Yes, and I believe we have been already starting that process by working with your staff and Congressman Dingell’s staff on this issue.

Mr. {Buyer.} All right. Well, I want to be as proactive as we possibly can. John Dingell, to his credit, started this a long time ago with his paper pedigree, and he has always had a great interest. It goes all the way back many years into the 1970s, and I applaud what he has done. I think he has got to be pretty shocked on where America is today compared to where we were in the 1970s, and as a policy and I know you adopted this, I was just as frustrated with the last Administration but I am embracing your spirit, and if we are able to move ahead, Mr. Dingell, I want to join with you today and I want to work with the FDA and I want to resolve this matter. I want to yield to the chairman for a second.

Mr. {Dingell.} I thank the gentleman. He is most kind to me, and I want to thank him for the kind comments he has made about me. I want to assure him that my assurances of the last Congress, I would be happy to work with him, and I happen to agree with the gentleman about the problem of imports, about tracing pharmaceuticals and other drugs, and I am pleased to report to the gentleman that very shortly we will be circulating a draft for comments about pharmaceutical safety, and I hope that the gentleman when that occurrence happens that he will look at it with sympathy and I look forward to working with him because he is a valuable member of the committee, and I thank him.

Mr. {Buyer.} I thank the gentleman. The last, can I do this piece of math? Thirteen-

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Mr. {Pallone.} The gentleman’s time has expired, but all the love–

Mr. {Buyer.} I ask unanimous consent for 30 seconds.

Mr. {Pallone.} Yes, with all the love and bipartisan here–

Mr. {Buyer.} God bless you.

Mr. {Pallone.} I certainly don’t want to stop the gentleman.

Mr. {Buyer.} Thirteen international mail facilities, on average 35,000 are pharmaceutical packages, times 365 days, that is 1,666,075 packages a year. If 80 percent are counterfeit, adulterated or knocked off, that means there are 132,860 pharmaceutical packages that are coming into the country that are either adulterated, counterfeit or knockoff, and people are taking these and they are not metabolizing in the body in ways in which as doctors you intend.

With that, I yield back.

To read the entire blog, visit: http://postscript.communitycatalyst.org/?cat=126.

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

Stolen Drugs Found Back in US Supply Chain

The US Food and Drug Administration is alerting the pharmaceutical supply chain regarding the reappearance of drugs stolen in a 2008 cargo theft.

On October 17, 2008, a shipment of Carbatrol and Adderall XR made by Shire Pharmaceuticals was stolen en route between the company's manufacturing facility in North Carolina and a distribution center in Florence, Kentucky.

In the theft nearly 35,000 capsules of Carbatrol, which expired between April 30 and May 31 of this year, were stolen.

Shire recently announced that some of these stolen pharmaceuticals have begun to appear in its expired returns and that some of the stolen medication may still be on the pharmaceutical market and a possible threat to consumers.

Shire warns that the drugs taken during pharmaceutical cargo thefts are unsafe because they may have experienced improper storage and handling or tampering outside of the secure supply chain. Additionally the drugs may have been adulterated or their packaging used for counterfeit medication.

The product lot numbers for the stolen Carbatrol are 2172127 and Adderall XR are 2385012.

Those who come in contact with these products should contact the FDA's Office of Criminal Investigations at 1-800-551-3989.

Secure Pharma Chain encourages all within the pharmaceutical supply chain to verify and authenticate the medications that they distribute and dispense to make certain that the product within their inventories are safe and efficacious.

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

Interpol: Over 80 Arrested in Africa in Police Operation on Counterfeit Drug Rings

In a story published in The Telegram on August 26th, Interpol is announcing that more than 80 people have been arrested and at least 10 tons of counterfeit and illegal medical products seized as part of a joint police operation in five east African nations since July 1st.

According to the story :

· "Operation Mamba III" involved the Lyon, France-based international police organization and a World Health Organization unit and targeted alleged networks of counterfeit drugs makers, traffickers and vendors.
· Interpol said Thursday about 300 sites were inspected or raided in Burundi, Kenya, Rwanda, Tanzania and Uganda. The operation was the third of its kind in three years.
· Many nations have noticed a recent increase in police seizures of fake medicines. Interpol said they are becoming more prevalent, sophisticated and dangerous.

International law enforcement agencies working across borders is a significant step forward in combating the global epidemic of fraudulent, adulaterated and counterfeit medications. Continued and enhanced international cooperation is vital in making a significant impact on this deadly criminal act.

Along with enhanced enforcement, Secure Pharma Chain encourages all within the global pharmaceutical chain to deploy anti-counterfeiting technologies to protect their businesses and consumers from deadly bogus medications.

To read the entire story, visit: http://www.thetelegram.com/Canada---World/Arts/2010-08-26/article-1700417/Interpol%3A-Over-80-arrested-in-Africa-in-two-month-police-operation-on-counterfeit-drug-rings/1

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

Canadian Man Sentenced to 33 Months in Prison for Online Cancer Drug Scam

This week, Hazim Gaber, 22, of Edmonton, Canada, was sentenced in Phoenix by U.S. District Court to 33 months in prison for selling counterfeit cancer drugs using the Internet. He was ordered to pay a $75,000 fine, as well as $53,724 in restitution, and to serve three years of supervised release following his prison term.

Garber admitted to selling counterfeit experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the United States, Canada, the United Kingdom, Belgium and the Netherlands between October and November 2007.

DCA is a highly sought cancer drug for its reputed ability to shrink tumors in lung cancer, breast cancer and brain cancer. However, the drug is experimental and not yet approved for use in either the United States or Canada.

The white powdery substance that Garber supplied to the victims was later determined through laboratory tests to contain starch, dextrin, dextrose or lactose, and contained no DCA. The packages also contained a fraudulent certificate of analysis from a fictitious laboratory and instructions on how to dilute and ingest the bogus DCA.

The sentencing is part of a larger department-wide effort led by the Department of Justice Task Force on Intellectual Property (IP Task Force) to combat the growing problem of IP violations and to protect the health of American consumers.

The case was prosecuted by Trial Attorney Thomas S. Dougherty of the Criminal Division’s Computer Crime and Intellectual Property Section and Assistant U.S. Attorney Peter Sexton of the U.S. Attorney’s Office for the District of Arizona. Significant assistance has been provided by the Edmonton Police Service, the Alberta Justice Office of Special Prosecutions-Edmonton, the Competition Bureau of Canada, the U.S. Postal Inspection Service, the Federal Trade Commission and the Alberta Partnership Against Cross Border Fraud. The Criminal Division’s Office of International Affairs provided assistance in this case. The case was investigated by the Phoenix FBI Cyber Squad.

XStream Systems applauds the IP Task Force and the FBI Cyber Squad for bringing this criminal to justice and cautions consumers against buying medications from questionable sources.

This story appears to be a classic case of a relatively unsophisticated individual taking advantage of and preying on the frantic needs of the sick with bogus drugs being peddled over the internet. His global scheme was aided by the relative anonymity and world wide access of the Internet which allowed him to market and sell his fakes to the desperately ill.

Unfortunately this tale is not an isolated occurrence but is something that happens all over the world on a daily basis. This appalling crime is being perpetrated by far more sophisticated and nefarious criminals who take advantage of people’s frantic need for healthcare and kill millions each year.

For more information visit:

US. Justice Department at http://www.justice.gov/opa/pr/2010/August/10-crm-958.html

“Canadian Man Charged in Online Cancer Drug Scam” at SecurePharmachain Blog

2010, The Year That Counterfeit Drugs Becomes a $75B Global Business

Alan Clock, SVP, XStream Systems, Inc.

As we find ourselves with a little over four months left in 2010, Secure Pharma Chain is re-posting a blog from January regarding the proliferation of counterfeit drugs globally this year.

In 2005, the Center for Medicines in the Public Interest (CMPI), released a report projecting global counterfeit drug sales to reach $75 billion in 2010. At the publication of the report, this projection was a 92% increase from the 2005 estimate of $39 billion of worldwide counterfeit drug sales. Most global experts then and now do not dispute this estimate. In fact, many would not argue the point that today, this estimate may be entirely too conservative and the real financial impact and overall number is much higher.

In 2010, we as a society face a global health catastrophe that will impact people of all countries, race, religion and economic strata.

What will be the key factor that will turn this issue around in the new decade?

"The business of selling fake prescription drugs to unsuspecting consumers is burgeoning, and is a global industry," stated Peter Pitts in 2005, senior fellow for health care studies at the Pacific Research Institute and director of the CMPI. "Nearly $39 billion, or 11 per cent of global pharmaceutical commerce will be counterfeit this year (2005)," added Mr. Pitts. "By 2010, that number will nearly double. We must enact controls to strengthen the security of our health care system from outside threats."

At the time that this report was published, Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration stated. "The increasing flow of counterfeit drugs represents a significant public health threat. We must step up our efforts to safeguard the drug supply -- we certainly should not weaken those controls."

Even with these dire predictions and public support for action in 2005, there has been little appreciable progress in the domestic and international efforts to stem the flow of this worldwide health care crisis. Regulatory, law enforcement and industry efforts to date have been inconsistent overall and seemingly lack an overall perspective of the severity and impact of this issue.

One of the most startling examples of the deadly impact of the global counterfeit medication epidemic is the World Health Organization’s (WHO) estimate that nearly 2,000 children die each day in Africa as a result of bogus drugs. Counterfeit medications in underdeveloped countries not only do not treat illness and disease but are now a major factor in creating drug resistant strains of deadly diseases such as malaria, tuberculosis and HIV/AIDS.

With the proliferation of counterfeit medications and the impact to people all over the world, the issue, in its extreme, is only now beginning to garner important public awareness.

The public awakening to this deadly scourge is the first critically important step in motivating public and industry leadership to move forward and take action.

With a motivated and aware public, elected and industry leaders will be encouraged to step up their efforts to protect their constituents, businesses and customers.

When properly inspired, these leaders will look to strengthening regulatory authority and in expanding their technology/ processes to thwart these nefarious sources of a deadly criminal act.

To learn more about technologies that are used to combat counterfeit medications, visit: http://www.xstreamsystems.net/.

How the Current Economy Will Drive Counterfeit and Fraudulent Medications

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

The following is a re-post of a Secure Pharma Chain commentary blog from October 30th, 2009.

The World Health Organization (WHO) has estimated that in 2010 the value of counterfeit medications worldwide will be approximately $75 billion. This is an increase from $35b in 2006 and it is now estimated that 10% of the global pharmaceutical supply chain is or will be counterfeit or fraudulent.

Although this estimate is dramatic in its size and growth, the WHO came up with this estimate prior to the true realization of the global financial meltdown and its impact on the world’s economies. As the impact of the financial meltdown continues to trickle through the populations of the developed countries it is anticipated by many that the worldwide estimates of counterfeit and fraudulent drugs may in fact grow beyond the $75b and begin to mirror the growth to those of emerging and non-developed countries.

Several economic factors will likelly drive this growth beyond the 2010 WHO estimates:

The rising costs of pharmaceuticals will simply become too much for many consumers to afford, especially when coupled with job loss, loss of health benefits or underemployment. Affordability will drive many to nefarious sources like the internet and many will fall prey to unscrupulous deals for bogus medications.

The lack of comprehensive laws or the ability to catch those who counterfeit, adulterate or fraudulent deal in bogus pharmaceuticals. Simply put it is very unlikely that those who perpetrate the crime will be caught or suffer any real consequence for their deeds.

The high profitability of the crime of counterfeit and fraudulent medications. It is widely accepted that anyone dealing in this crime will likely profit many times more than others dealing illicit street drugs.

Lack of regulatory oversight of the legitimate pharmaceutical supply chain which allows for systematic gaps in the supply chain that can be exploited by those with criminal intent.

The globalization of the manufacturing and raw materials process. Most medications consumed in developed countries have been outsourced to non-developed countries for economic reasons. This creates huge gaps in the quality of the product and lack of regulatory oversight which is critical and necessary for the protection of the supply chain from criminal enterprises.

Solutions to this issue within the pharmaceutical supply chain are also heavily impacted by the global economy. Track and Trace, Taggants, Serialization, Pedigree and Authentication solutions are all very effective in dealing with counterfeit, fraudulent and adulterated drugs but diminishing capital expenditures budgets and tight margins by manufacturers, repackagers, distributors and dispensers are hampering the deployment of the tools needed to eradicate this very dangerous threat to public health. Without regulatory mandates or incentives, businesses cannot easily justify the expense of solutions until or unless their business is or has been affected by counterfeit and fraudulent medications.

The initial WHO estimates were troubling enough but it would appear that based on the current economic conditions their predictions may prove to be more optimistic than what we may ultimately realize in our global pharmaceutical supply chain.

To learn more about solutions to combat counterfeit, fraudulent and adulterated medication, visit: http://www.xstreamsystems.net/.

Comparison and Combination of Spectroscopic Techniques for Detection of Counterfeit Medicines

ScienceDirect.com has made available an online report comparing spectroscopic techniques in the detection of counterfeit medications.

In this highly technical report, scientists studied Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy to determine which techniques and associations were the best for discriminating genuine from counterfeit and imitations samples.

The medications tested were counterfeit and imitations of Viagra and Cialis two of the most counterfeited products globally.

According to the report:

It is shown that for the Viagra® samples, the best results were provided by a combination of FT-IR and NIR spectroscopy. On the other hand, the best results for the Cialis® samples were provided by the combination of NIR and Raman spectroscopy (1400–1190 cm−1).

These techniques not only permitted a clear discrimination between genuine and counterfeit or imitation samples but also the distinction of clusters among illegal samples. This might be interesting for forensic investigations by authorities.

Secure Pharma Chain endorses all techniques and testing as it relates to being able to detect and interdict fraudulent, adulterated and counterfeit medication however technologies are in use today within the supply chain that allow for the accurate testing of pharmaceuticals within their sealed, unit of sale container.

Unlike Spectroscopy, these technologies do not require destruction or degradation of the product, laboratory testing or technicians to run and analyze testing results.

EDXRD allows the end user to deploy forensic level testing without opening up the container for testing or sample prep. Additionally EDXRD can accurately test products within the supply chain by warehouse resources within seconds.

To date the EDXRD testing has accurately, efficiently and effectively protected the supply chain end user from receiving or shipping adulterated, fraudulent or counterfeit drugs including Cialis and Viagra.

Spectroscopy is an excellent technology when you need very specific forensic sampling, but when you need to know if your inventories are safe before you ship them,

you don't need a laboratory to interdict counterfeit medications.

To read the entire survey report, visit: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TGX-504127R-1&_user=10&_coverDate=11%2F02%2F2010&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=f9acd7f0661b04a5da0138dbac9966fa.

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