Saturday, February 12, 2011

Drug safety;Counterfeit Medicines

A few days ago I posted this alarming FDA alert about counterfeit drugs. I wanted to to explore this in more detail but my two year old grandson, my love, my heart was here visiting me, after he said "Target grandma" we were off.

Today, I thought it was time to bring myself up to speed on the world of counterfeit drugs. I found my starting point when I read at US Today what really fueled the counterfeit drug market, it all began with one little drug, Viagra. In the 1990's Pfizer's drug Viagra gave men a staying power which for good reason soon went on to become in high demand, or low demand depending on the man, I suppose. However, men being men, were not conformable with visiting the general practitioner for a prescription. Enter, online pharmacies, the "perfect storm" was soon created and thus the underground industry took off.
I didn't realize the magnitude of the problem, with the sale of these fake drugs now a global problem. Apparently the technology is so widely available to produce these active pharmaceutical ingredients, that fake drugs can be manufactured anywhere, and they are. These facilities produce the drug, label it and wrap it up in a perfect deceptive package.
If you think these drugs aren't hitting close to home you're mistaken folks. The HCV community is familiar with the drug Procrit (epoetin alfa), in 2003 a counterfeit version of the drug was seized by U.S. government officials. The fake drug contained nothing but bacteria-tainted water. Last year the FDA warned the public of fake versions of the flu drug Tamiflu, remember? The drug was sold through Internet pharmacies, without a prescription; the drug contained an active ingredient that could be deadly to people allergic to penicillin.

A Few Examples From The FDA;
Drugs purchased over the Internet by an American patient who was told that the products were manufactured in the United States and were being sold from Canada. The drugs he actually received are fake “knockoffs” from India.

The Internet is home to counterfeiters who have no doubt found a direct access to consumers. Most of the illegitimate online pharmacies are based outside the U.S., with these sites providing cheaper prescription medications under the term "generic". Many of the popular drugs purchased online are for "lifestyle" conditions; wrinkles, herpes, acne, obesity, or baldness. However, a large amount of counterfeit drugs such as antibiotics are also sold, these drugs are often ineffective because they do not contain enough of the active ingredient to aid the consumer. The individuals who purchase these counterfeit drugs may become seriously ill, and end up seeking medical treatment from the physician they started out to avoid.

FDA Cracks Down On Internet Pharmacies

Recently, an online pharmacy was blown wide open at the end of January, this was released by the FDA ; "Manuel Calvelo, 37, a citizen of Belgium pleaded guilty to charges filed in U.S. District Court in Kansas alleging he operated an Internet pharmacy that sold $1.4 million worth of misbranded and counterfeit drugs as well as controlled substances. Calvelo’s Web sites offered for sale more than 40 prescription drugs including brand names Viagra, Depakote, Glucophage, Zoloft, Lipitor, Cialis, Xanax, Ativan and Klonopin. Controlled substances for sale from the Web site included Alprazolam (sold under the brand name Xanax), Lorazapam (Ativan) and Clonazepam (Klonopin).

Calvelo’s Web sites included,,,,,,, and

Counterfeit Drugs At Your Corner Pharmacy and Hospital

The assumption for most of the public, including me, is that counterfeit drugs are mostly just sold online, however some of these drugs make their way into the U.S. drug supply and then to your local pharmacy. How is this accomplished ?
Clarified at the website "New Momentum’s"; "Within the legitimate U.S. supply chain, medicines are commonly sold directly by pharmaceutical companies to major authorized distributors, which then supply them to hospitals and pharmacies where they are dispensed to patients. However, drugs may also move sideways from the authorized distributors to middlemen or secondary wholesalers who sell drugs to one another. It is at this point that fake or unapproved and potentially dangerous drugs from other countries can enter the U.S. supply chain.

As I continued reading various reports online, I realized the devastation felt across the globe, with Africa receiving an overflow of counterfeit medicine. A few examples are malaria tablets, heart treatment medication and even H1N1 vaccines, all because of the financially lucrative trade of trafficking fake drugs.

In Southeast Asia counterfeit malaria tablets are killing children, and adults alike. If you have the time this 2010 story; "The Fatal Consequences of Counterfeit Drugs" by Andrew Marshall published at the Smithsonian is a chilling look into the reality of counterfeit drugs. Just one quick astonishing statistic from article; "The World Health Organization (WHO) estimates that counterfeit drugs are associated with up to 20 percent of the one million malaria deaths worldwide each year"

Pharmaceutical companies have taken the initiative and have become actively involved in finding a solution to the globalisation of counterfeit drugs. Rather it is to protect their own interest or not, the need is great and the effort is appreciated by this concerned citizen.

Last week over at ABC Radio on the "Health Day" program reporter Joel Werner reported on the seriousness of the problem. A guest on the show, Greg Simon the Senior Vice President of Pfizer was interviewed and discussed the globalisation of counterfeit drugs and how it has allowed substandard medications to flood the international pharmaceutical market. Simon remarked during the broadcast "To really follow this story you have to realise just how substantially the drug industry has changed over the past 20 years. It used to be that big pharmaceutical companies such as Pfizer, Merck and Eli Lilly were responsible for most of the world's medicines and these companies were based in nations with strong regulation.
But according to Besser this has now flipped, with most of the world's trade in pharmaceuticals controlled by others. And it's these new markets in developing countries that are creating the demand for cheap, affordable meds, a demand met in part by counterfeiting."

For more on the story you can listen to the broadcast or read the transcript .

Quick Video From CNBC 2010;

Helpful Links;
How do you know if your online pharmacy is safe ?
The National Association of Boards of Pharmacy (NABP) has created a database of online pharmacies that are appropriately licensed and operating legitimately on the Internet.
Click here To check your pharmacy with NABP’s Verified Internet Pharmacy Practice Sites (VIPPS) by entering its web address.

Find a VIPPS online pharmacy
You have options when you are buying medicine online, but the safest way to purchase drugs online is through pharmacies accredited by the VIPPS or Vet-VIPPS programs. Choosing to buy your prescriptions from a trustworthy provider can help eliminate the risks associated with sites that fail to comply with federal and state laws and regulations. Protect yourself from these rogue sites and select a VIPPS pharmacy for you and your family.

Counterfeit Medicines - Filled With Empty Promises
You can avoid counterfeit medicine by purchasing
only from U.S. state-licensed pharmacies.

(NAPS)—While counterfeit medicines are rare in the United States, you must take an active role in managing your medicines to ensure you’re not at risk. Here are some important facts about
counterfeit medicine from the Food and Drug Administration (FDA).

Counterfeit medicines are fake or copycat medicines. They may:

be contaminated
contain the wrong active ingredients (the formula that makes the medicine work)
be made with the wrong amount of ingredients
contain no active ingredients at all
be packaged in phony packaging.
Medicines that are counterfeit may not help the condition the medicine was intended to treat and may lead to dangerous side effects. How can you avoid counterfeits?

Purchase ONLY from state-licensed pharmacies that are located in the United States, where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. This way, you know your medicine is coming from a reputable source, and you can get help if you have any problems with your medicine. If you buy over the Internet:
Check to see if a pharmacy is licensed, is in good standing, and is located in the United States. Contact your local state board of pharmacy or the National Association of Boards of Pharmacy (NABP) at 1 or 1-847-698-6227, or
Check to see if an Internet pharmacy site has the VIPPS Seal, the seal of the Verified Internet Pharmacy Practice Sites Accreditation Program. This program was established by the NABP to help protect you and guide you through Internet pharmacy shopping. Legitimate pharmacies that carry the VIPPS Seal are listed at

Know your medicine. Any time you get a prescription refilled, check the color, texture,
taste and shape of the medicine. Anything different? Talk to your pharmacist.

Give your doctor and pharmacist a complete list of all medicines (over-the-counter and prescription) that you use. They will also want to know what dietary supplements you use, including vitamins and herbals.

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