6th Global Congress Combating Counterfeiting & Piracy‏

First, I want to thank Mr. George Kearse for emailing me a few weeks ago telling me about this event. Also, it was awesome that my blog was mentioned! Thanks.

The 6th Global Congress Combating Counterfeiting & Piracy‏ was held in Paris on February 2-3, 2011. From the website it says that this congress aims to build cooperation to enhance public awareness — and concerted action — to successfully confront these problems. It seeks to create a better understanding of the elements fueling the trade in illegitimate goods and to develop sustainable solutions to stop it.

There will be materials concerning what was talked about at the event up shortly on their website. I would advise for you to keep checking it. However, I did receive some information from George Kearse about his talking points. He spoke about consignments and shipping and he said, “We have to be constantly reinventing ourselves to be ahead of the game!” I really liked his speech on public awareness. This blog is aimed towards that. I try to keep things updated so that tihs problem can be known.

He goes on wondering what is being done about public awareness, such as campaigns. Just as he stated “where are the posters?” I’ve been wondeirng the same thing. I follow a few people on Twitter that talk about this problem, but generally no one knows this is a problem at all. This problem affects us all,even our pets! The WHO has a taskforce aimed at counterfeits called “International Medical Products Anti-Counterfeiting Taskforce” The taskforce, created in 2006, has been active in forging international collaboration to seek global solutions to this global challenge and in raising awareness of the dangers of counterfeit medical products.

Please go on the congress webpage to get more information. Please spread the word out about counterfeits! Follow me on twitter @JustFinishIt.  Another GREAT account is @SafeMedicines <— Just for pharmaceuticals.

Safe Medicines Interchange

Today, I was at the Partnership for Safe Medicine’s 2010 Interchange. I had the ability to attend and listen to a bunch of speakers and learn many different things about counterfeit drugs from various perspectives. It started this morning at 8:30 with a panel discussion headed up by Dr. Marv D. Shepherd. The next panel was headed by Dr. Bryan A. Liang and the last panel was lead by Tom Kubic. The Interchange adjourned with Margaret Hamburg’s, the FDA commissioner, remarks.

The whole conference was very enlightening. I felt educated today. Also, I could actually talk with others about this topic and I could follow along with the panels and come to my own conclusions. If you missed the panels or the commissioner’s discussions, you can click HERE to view in the C-Span archives. I will quickly summarize each of the panels and what I got out of them. Watching the video feed would be more beneficial. There is so much good information there.

Panel 1: Who’s Getting Hurt by Counterfeit Drugs?
I thoroughly enjoyed what Rick Roberts had to say. He talked about his encounter with counterfeit medications. It is an amazing story. Consumers need to be more educated in light of their medications and what they are taking. He takes over 10,000 pills a year. He has to depend on prescription drugs to stay alive. Most Americans use medications everyday from multi-vitamins to Insulin shots. AZT was the drug that Rick took because he was infected with HIV. His friends were dying. It was tough. Then in 2000 he was diagnosed with HIV-wasting syndrome and had to take a growth hormone that is injected daily. Halfway through he noticed a stinging of the injection sights. With his experience prior with the drug, it never stung him before. He started checking out the different sets of drugs he had and then he asked for his pharmacist and told him of the stinging and problems. His pharmacist told him to go home and check because they may be the fake stuff. Basically, Rick went home and check he compared the boxes and found a box and some darker ink and missing a symbol, etc. He had counterfeit meds. I also liked what Salvatore Giorgianni said about counterfeits. He was talking about his son in the beginning, who is a pharmacist. His son asked his dad “countefeits drugs… there are such things?” Salvatore Giorgianni is saying that we need to let people know about this. I agree with him. EVERYONE is affected and everyone should know about this. He finds it amazing that people pay more attention to what pet food they buy and what oil they put in their cars. We need to pay more attention to what is in our own bodies! If we cannot work our bodies then we cannot buy our pet food and we cannot buy our oil. The whole panel was very good.

Panel 2: Who’s Benefiting from Unsafe Drugs?
Basically, what I gathered was that the bad people are the only ones that benefit. Nancy Kennedy, Food & Drug Administration, Office of Criminal Investigations, deliberately states that the bad guys are the ones benefiting. Jeffrey Gren, from the U.S. Department of Commerce, states that the criminals are at every level of manufacturing. This is so true and so scary. Your medicines can be tainted at ANY level. The beginning process to the end process of shipment and even at the pharmacy. To me it seems a lot of this boils down to money. Even though the conference stressed the consumer side the most. I do not even have to wonder why people do what they do… usually, it boils down to money.

Panel 3: Who’s Making Progress Against Counterfeit Drugs?
After a great lunch and a great talk by Bejon Misra, Healthy You Foundation (India). We all proceeded back to the conference room and heard from more speakers on this topic. Dr. Michael Green, Centers for Disease Control and Prevention, talked about PH levels in counterfeits and how you can tell they are fake because of the levels in them. There are simple field tests that can be done and there are tests where you collect the drug sample and sent it to a lab equipped with a HPLC (High-performance liquid chromatography). It got pretty technical in this panel. Sending drugs to a lab takes a while though and new technology will help this process way faster so that consumers can get information faster and then recalls of “bad” medications can be stopped. This will save money and lives. Hugo Bonar, Irish Medicines Board, talked about Europe and the initiatives going on there. He stated that,  “By the end of the day the focus is to get the packaging with security measures on them.” Medicines need to be checked at point of dispensing by the pharmacist. It seems that there is some progress being made, such as organizations addressing products and manufacturing, but we are still a long way to go. With as big of an issue that this is more people need to know!

FDA Commissioner Remarks.
Dr. Margaret Hamburg, who is the FDA commissioner, mostly summarized how bad counterfeits are and what the FDA’s goals are. She talked about the FDA beginning with the “pure food and drug act”. She says that, “We must use all the tools are our disposal to do the right thing.” With the information you receive… do the right thing.

I would highly recommend going back and watching the videos. Each of the panels were great and had good information. You can visit PSM’s website and find the whole agenda and then go to C-Span and watch each individual panel if you choose. At least educate yourself just a bit more on this topic.

More $$$ in Counterfeiting than Heroin

I came across an article today that was posted a few days ago from USAToday. The article called “Growing Problem of Fake Drugs Hurting Patients, Companies.”

“You can make more money in counterfeit drugs than heroin,” says Tom Kubic, CEO of Pharmaceutical Security Institute (PSI). “There’s a major financial incentive for criminals because of the low risk of detection and prosecution.”

From all of my research on this subject. I have come to the same conclusion. Everyone wants/needs medicines. Half of the time people do not even realize they are counterfeits. Some people may realize the risk, but go ahead anyways because that risk outweighs their health and money status.

There are so many things wrong with counterfeits it is amazing. Different people and sectors are hurt from this problem; property rights are infringed upon, medicine companies lose profits, patients’ health worsen, jobs are lost, gangs get more “funding”, etc.  Since 2004, counterfeit drug incidents have tripled! 1,700 incidents were reported world-wide last year. PSI estimates the size of counterfeit drug market range from $75 billion to $ 200 billion a year. Honestly, this number is bigger due to the lack of detection.

Scott Davis, a senior regional director in U.S. drug giant Pfizer‘s global security division, believes the “lack of education and awareness of the dangers,” is what drives consumers to purchase counterfeit medicines. Counterfeits have been around for years and have become harder to detect. About 50% of medicines purchased from online retailers have found to be fake says the WHO (World Health Organization). Bryan Liang, a professor at California Western School of Law in San Diego and a Board Member for the Partnership for Safe Medicines (PSM) says the “perfect storm” from the popularity of Pfizer’s erectile dysfunction drug, Viagra, in the 1990s fueled the underground economy of selling fake pharmaceuticals.

Counterfeits are a real problem. It is a shame that it is not a more “well-known” public health issue.  Education of this problem would be very beneficial to all. I encourage everyone to read more on this and spread the word and use your education to be a better consumer.

Unneeded Regulation

I just recently wrote a blog post for the Property Rights Alliance, which is part of my internship. It is a better write-up of it than I previously did earlier on this blog. To read the article, click here.

Here is a little brief overview… The FDA is wanting to regulate cough medicines, which I mentioned earlier. This is not a good idea at all. Property rights and safety will take the ultimate toll. After property rights and safety what much left is there? To read more about this regulation you can follow it at ATR or the PRA website.

Cough Medicines May Become More Regulated

I recently stumbled on an article called “Regulatory Overreach in the Making: FDA Sets Sights on Cough Medicines” on the American’s for Tax Reform (ATR) website. Grover Norquist wrote a letter to the Drug Safety and Risk Management Advisory Committee. This article was written by Mattie Corrao on August 9, 2010. Since I am doing my internship here for ATR, I constantly look on the website and find good timely information.

This article about cough medicines focused more on the tax side. It makes sense considering where I retrieved the source, but regardless… To me, this means that cough syrup could potentially be counterfeited more. In reality every medication taken could be counterfeited, but when there is a need for something then it seems that people will go to great lengths to fill that need. That is a big reason there are counterfeits. Since the cough medicines might be more regulated, thus increasing health care costs, that means people are going to want to find cheap alternatives.

If our cough medicines become more regulated then, I believe, more counterfeits will pop-up in the United States and more people will be buying them. In the 1990s when I was just a child, there were children in Haiti that took cough medicine and died. The cough medicine was made out of antifreeze [Counterfeit Drugs: Coming to a Pharmacy Near You (Condensed Version)].  People stricken with poverty will usually buy any medication if it is cheap and could possibly help. If cough medicine is more regulated then more people will be buying them illegally.

International Property Enforcement Coordinator

I was able to watch the IPEC webcast online. They mentioned a little bit about counterfeit drugs, but mostly about downloading music and how China is the biggest offender with counterfeiting medical devices. The hearing was about 2 hours and some of the Senators there seemed bored. It was funny they just had to announce how the U.S. won the game in the world cup. Anyways, here is just a quick paragraph of my notes that I took while watching.

Victoria A. Espinel talked the most in the beginning about counterfeits. They were also mentioned throughout the hearing, but nothing too new about the problem. China is the greatest counterfeiter of medical devices and there has not been a lot of improvement in China. They have created a counterfeit pharmaceutical agency committee that is geared towards helping the fight against counterfeits. They want to strengthen relationships with organizations. They are going to increase the efforts on enforcement with FDA and other agencies. Also facilitate infringement over the internet and reduce fraud online with various tools and strengthen IP enforcement.

Here is a press release on it for more information. It is called “Conyers and Smith Welcome IPEC Report and Urge IPEC Be Given Sufficient Resources“

Here is another interesting article about global piracy that might be of interest to look at as well: “White House Touts Anti-Piracy Strategy“

Online Pharmacies

In today’s world we can buy virtually anything online; from nail polish, bed sheets, and music to medicines. It is a great blessing that we have such technology that allows the globe to be connected so quickly. Keeping in touch with relatives on the other side of the world has never been easier (I do not speak from much experience due to my age, but I am glad I was born into all this easily accessible technology).

When I typed “buying drugs online” into google the first few results were from the FDA. This gives me peace of mind because there are plenty of non-reputable sources that have an opinion on buying drugs online and say it is safe and cheap. Those two words will appeal to anyone if they are not educated enough in counterfeiting. The FDA lists some positive points and negative ones in regards to purchasing your medicines online.

Good points:

1. Easier to get products without leaving your home.
2. Check different sites for products and prices.
3. Ask pharmacist questions privately.

Bad points:

1. May not know the cause of your health problem. They could also give you the wrong medicine for your illness.
2. Some sites will sell you prescription drugs even if you don’t have a prescription. This is against the law.
3. Don’t protect your private information, like your credit card number.
4. With Medicines sold online… some are fake, too strong or too weak, too old to work, are not approved by the FDA, are not labeled, are not stored or shipped right away, are not safe with out medicines or products you may use, not made using safe standards, and have things in them that could be harmful.

For a list of places to look for counterfeit drugs or more information visit my Related Links section. A link in that section I have posted is for the National Association of Boards of Pharmacy (NABP). They have a buying drugs online page and have reviews of online pharmacies that would be a big help in your quest to purchase pharmaceuticals online.

Another web page I find very helpful is called ScamWatch. They deal with a variety of online offenses; money order, medical, lottery, chain letters, banking, etc. VERY HELPFUL site!

E-Prescriptions

Today there seems to be a big push towards doctors filing  “e-prescriptions.” What does this mean? Well, researchers say that it means doctors are less likely to make a mistake in prescribing the medication. Weill Cornell Medical College physician-scientists conducted a study that showed that when doctors and health care providers use an electronic system they are 7 times less likely to make an error opposed to writing them out by hand.

I found an article on the medical news today website and thought it was pertinent to the subject of this blog. The article is called Electronic Prescriptions Reduce Errors By Seven-Fold.

Dr. Rainu Kaushal states that they “found nearly two in five handwritten prescriptions in these community practices had errors.” When talking about prescription drugs that is huge! These errors are not likely to be lethal, but they are errors nonetheless and can be damaging.

This article describes a study done in New York: Researchers looked at the prescriptions written by health physicians at 12 different community places in the Hudson Valley area. They compared the prescription errors between 15 health care providers who used e-prescriptions and 15 who wrote them out by hand.

This is what they found: The authors reviewed 3,684 paper-based prescriptions at the beginning and 3,848 paper-based and e-prescriptions a year later. The percentage of errors, after one year, was astounding. They dropped from 42.5% to 6.6% for those using the electronic system. The ones who wrote prescriptions by hand has slightly increased from 37.3% to 38.4%.

Benefits of e-prescriptions: Looking at the Government’s Health and Human Services website they give some reasons electronic prescriptions are beneficial. Here are a few reasons why it is beneficial. (Article: The Benefits on Electronic Prescribing)

1. Improve quality and proficiency
2. Reduce costs (co-payments)
3. Work-flow efficiencies
4. Eliminate ineligibility problems of hand-written prescriptions
5. Reduce incidence of drug diversion by alerting health care providers (i.e. duplicating prescriptions)

When dealing with counterfeit drugs electronic prescriptions may or may not help. It seems to be very beneficial. The consequences though, may be that people are more apt to purchase their drugs online since the prescriptions are electronic. This could pose as a huge problem and a better way to get fake pharmaceuticals to more people. Consumers are still going to have to be smart.

EXAMPLES:

Hand-written prescription

Electronic Prescription

Malaria

Left=Fake. Real=Right

Malaria is a tremendous concern in Africa so antimalarial counterfeit drugs are one of the biggest problems they face. Each year it is estimated that malaria kills 1.5 million people, those of which are mainly children. This parasite has become resistant to most antibiotics and drugs. In 2006, there has been a recent introduction of antimalarial drugs made from the artemisinin plant and has subsequently revolutionized the healing of malaria. The drug taken from this plant to fight malaria is called artesunate. Up to 90% of artesunate that is used is fake. The problem about artesunate is that it is in high demand and very expensive. Therefore, the counterfeiting industry has taken it upon themselves to help create a drug to make it relatively inexpensive for Africans. This has helped the counterfeiting industry thrive. These forged drugs have enough of the plant to fool the laboratory tests, but do not have enough of the artesunate needed to help treat people.

International Coordination System

I found a website called Sanofi-Aventis. They are becoming a global healthcare leader, that is their vision.

Chris Viehbacher is their CEO. On their website it states they they are “Focused on patients’ needs, sanofi-aventis offers a range of essential healthcare assets, including a broad-based product portfolio and a presence worldwide.”

I found a page about counterfeit drugs. They have organized an international system on controlling the use and production and detection of counterfeit drugs. Here is a visual on the website about the corespondents and coordinators.

Click on Map for the whole picture