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FOR IMMEDIATE RELEASE: August 7, 2005

SCHUMER REVEALS: MILLIONS OF NY’ers AT RISK
AS GAPING HOLES IN Rx REGULATIONS ALLOW CRIMINALS TO INTRODUCE COUNTERFEITS INTO DRUG SUPPLY CHAIN

Those Most at Risk Including, Elderly, Cancer Patients, Transplantees, are Targeted

Schumer Stands with Tim Fagan, a Victim of Counterfeit Drug Treatment Following His Liver Transplant and Parents

Counterfeit Drugs Can be Harmful, but even Those that are Harmless can Cause Severe Injury Because Patients Aren’t Getting Real Drugs that they Need

As cases of counterfeit drugs have nearly doubled in the past year, endangering anyone who takes prescription medication, today U.S. Senator Charles E. Schumer detailed how these counterfeits can enter the drug supply and cause further illness and even death to patients. Schumer, standing with Tim Fagan, a victim of drug fraud, and his parents, announced legislation in the United States Senate to combat this deadly scourge.

“These criminals have found a loophole to exploit and now can go around the safety mechanisms trusted by trained doctors and pharmacists and endanger the lives of Americans. It's time for the Federal government to step up the effort to shut them down" Schumer said. “We shouldn’t have to play Russian roulette with our prescription medication.”

A new gray market of pharmaceutical drugs allows criminals to introduce counterfeits into the drug supply, contaminating it and endangering patients, especially the most vulnerable. Prescription medications, before getting stocked in a pharmacy can follow a long and winding path that leads them through wholesalers and repackagers. Most wholesalers are honest brokers, but the occasional criminal can taint the entire system by introducing counterfeits. When repackagers and wholesalers get their medicine from anywhere other than the manufacturer it becomes easier to counterfeit. Once outside the normal distribution system the rules aren’t as stringent. For example, at times, low priced drugs that are distributed to health clinics or Medicaid programs are taken from those places and sold at a higher price.

Though there are various mechanisms of counterfeiting a drug the most common way is to interfere with the active ingredient either by: changing it, watering it down, using too much, or switching it altogether. Results can be very harmful and even deadly. In most cases the most infirmed are targeted as medicines to treat HIV, cancer and transplant recipients are the most expensive.

According to the Food and Drug Administration, cases of counterfeit drugs are up nearly 100% nationwide in the past year. According to National Association of Chain Drug Stores, in 2004 in New York there were over 220 million prescriptions for a cost of over $16 billion. For New York City that translates to over 92 million prescriptions for a cost of almost 7 billion dollars. New Yorkers could be buying over 93,000 counterfeit prescriptions a year at a counterfeit cost of almost 7 million dollars.

In 2002, Procrit, a drug used to treat Cancer and HIV patients to combat fatigue and other symptoms was counterfeited. Counterfeiters diluted the medicine with tap water that was non sterile, making the medicine a fraction of the strength of what it was supposed to be. The tap water increased the risk of infection in these patients exponentially. Other drugs such as Lipitor, Viagra, and Epogen have also been recently counterfeited.

Schumer today stood with his consitituent Tim Fagan and his family. In 2002 after Fagan had a liver transplant he was prescribed the prescription drug Epogen , which he was to be injected with to increase his red blood cell count which was depleted after his surgery. The Fagan’s purchased the drug from a major pharmacy. Each time Tim was injected with the drug he would suffer from terrible, crippling muscle spasms that would make him scream in agony. His doctors were bafffled, and after looking further into Tim’s reaction, the Fagan’s discovered that Tim was being treated with counterfeit drugs.

“The bottom line is, we shouldn’t be concerned that medicine we take to make us better will actually make us sicker,” Schumer said. “We should not have to worry that our medicines have been tampered with, contaminated, relabeled and counterfeited”

In an effort to combat this dangerous scenario, today Senator Schumer announced legislation to improve the tracking of drugs as they make their way from the manufacturer to the hands of patients.

Schumer’s legislation will:
• Beef up criminal penalties for people who make counterfeit drugs or knowingly sell them
• Phase in over five years a mandate for drug manufacturers and distributors to keep a record of where the drug has been between the time it left the manufacturer and arrived at the pharmacy
• Allow more resources for the FDA to conduct random inspections of drugs
• Give the FDA the authority to recall prescription drugs if they are expected to cause serious harm to consumers

Congressman Israel is working on a different bill in the House aimed at solving the same problem.
Schumer today was joined by Tim Fagan and his parents Kevin and Jeanne.

For additional information on counterfeit drugs:
Dangerous Doses
http://www.dangerousdoses.com
The Turkewitz Law Firm Counterfeit Drug Resource Page
http://www.ericturkewitz.com/counterfeit-drugs.htm
The National Consumers League
http://fraud.org/fakedrugs/
The Food and Drug Administration
http://www.fda.gov/counterfeit/

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