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Pharmaceutical managed care professional, consultant to Wall Street, SME, public speaker, biomedical ethicist. Big Pharma, Major Payer, PBM, and Biotech experience; chronic pain sufferer, and PTSD survivor. Advocate for appropriate and compassionate care for chronic pain sufferers no matter what a person's situation may be. Passionate about patient access to medicine and appropriate/timely health care for every man, woman, and child. Committed to the prevention of suicide, interested in finding ways to bring drugs to market safely and more efficiently as well as committed to care that treats the entire patient - physical, mental and spiritual = the human condition. Deep connection with God and all of the gifts he's provided; special place in my heart for animals and children. Strong belief that while developing employees you expose their greatness as well as your own! Fascinated by the changing healthcare environment every day!

Why Everyone MUST Care About Counterfeit Drugs

Knock off purses and Rolodex watches are one thing; most of us can spot them along with their sellers on the streets. We know what they are and we purchase with full awareness that we’re not getting the real deal.

But what about goods we rely on every day? Sadly, a little over six years ago Asia Pacific was plagued by a spurt of criminals selling counterfeit infant formula. The counterfeit formula was so intermingled with the real brand it was almost impossible to discern.

In fact, the fake looked so much like the original product, there simply was no way for parents to know if they bought the genuine product or the counterfeit formula and therefore were unaware that the counterfeit formula they were feeding their babies had no nutritional value until it was too late.

“Officially, 13 babies died and more than 170 suffered serious malnutrition as a result of drinking the fake milk powder. The toll’s almost certainly far higher, locals say. The milk powder packets have been sold locally for nearly two years, they add, resulting in untold numbers of deaths before angry residents finally made the link.” The actual number of infant deaths was much higher when the scandal was finally unraveled.

Fast forward to 2012: drug dealing criminals have figured out they can infiltrate the complex global drug market and make 10 x the money that they’d make on street drugs all while facing much lower risk of hard prison time.  For example, 3-5 years in prison as compared to 15-20 years for street drugs like heroine and cocaine. Additionally, it’s a lot harder to trace the drugs back to individuals – by the time the trace is completed, the criminals can be long gone and setting up shop somewhere else.

Almost two months ago, the US was rocked by news that fakes copies of a cancer drug were making their way through the US and into patients’ via infusion centers and clinic sites. It didn’t take long to determine that the source of the drugs were poorer counter with less restrictive regulations than the US.

According to an Associated Press article from February 28, 2012, “because medicines and their ingredients continue to be manufactured overseas more cheaply than in the U.S., the U.S. Food and Drug Administration (FDA) and other government agencies are concerned that more fake drugs will make their way to the U.S. and place patients at risk. The news of the fake Avastin spurred cancer physicians, hospitals and clinics immediately to check their records.

Not only cancer fighting products, but other widely used drugs including popular “lifestyle” drugs like Viagra and Cialis, and cholesterol lowering giant Lipitor all have been targets for manufacture of counterfeits. Reportedly, Connie Jung, FDA’s associate director of the Office of Drug Security, said in February that “the FDA was aware that counterfeits are continuing to try and make their way onto the U.S. supply chain.” A more recent CNN report, from March 15, 2012, noted “that the fake version of Avastin had been purchased by 19 hospitals and medical centers.”

It’s been reported that the fake drugs didn’t include any active ingredient but instead included ingredients like “salt, starch alcohol, and other chemicals, and [were] packaged in counterfeit boxes.”

Apparently some of the fakes are being manufactured to look very much like the original product and are quite difficult to detect. This should be a wake up call to the FDA, congress, manufacturers, distributors, and law enforcement.

There is also concern that the current and unprecedented number of drugs on short supply will just pour fuel on the demand for counterfeit drugs.  See:  Drug Shortages: A Crisis of Epidemic Proportion

Many of the drugs on short supply in the U.S. are life-saving products for children, and only-option drugs for those with rare and serious illnesses.

So the next time you fill your prescription, think about the safety you’ve enjoyed in the U.S. for virtually most of the history of the FDA  - freedom from worries about counterfeit drugs or purposeful contamination. Everyone should have the right to demand that the US drug supply is safe!

There is help on the way; “in mid-March, the U.S. Senate unanimously passed S. 1886, the Counterfeit Drug Penalty Enhancement Act, which increases penalties for trafficking counterfeit drugs. If passed in the House, the law will aim at violators who knowingly manufacture, sell, or traffic counterfeit medicines in the United States. The status as of March 28, Subcommittee hearings had been held in the U.S. House of Representatives on a House version of the bill, H.R. 3668.”

Additionally, there are drug pedigree laws underway to create standards for drug manufacturers to track products globally through the use of technology like bar coding to track products as they make their way through the supply chain – instantly, and seamlessly.
To follow the evolution of the drug pedigree laws, visit: http://www.rxtrace.com/

Sources:

Phony Baby Formula Proves Tragic for Many Poor Chinese

Mark Magnier | Times Staff Writer

Invasion Of The Fakes: Big Bucks May Be Drawing Counterfeit Medicines Into US Associated Press, The Daily News Record, February 16, 2012

Counterfeit Medicine Still Crossing US Borders – Greg Webb

FDA Finds New Batch of Counterfeit Avastin WSJ – Jonathan D. Rockoff and Christopher Weaver

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