Worldwide, counterfeit drugs kill more than 1 million people each year. The recent conviction of a Palm Harbor oncologist demonstrates that Florida patients are directly at risk.
Unregulated, illegally imported medications have become a big threat to public safety. Over the years, cancer patients have received fake medications containing salt and starch and no active ingredient at all. Counterfeits are reaching hospitalized liver transplant patients, as well as schizophrenia, high cholesterol and impotency patients. Also affected are heart, antibiotic, hair loss and arthritis patients, as well as those suffering from Parkinson's and HIV/AIDS. In one case, a foreign-sourced blood thinner was suspected to have resulted in as many as 81 deaths.
Florida is ripe with illicit activity — with online pharmacies becoming an increasingly common source of counterfeits and illegally imported medications. As consumers flock to the Internet to find savings and discounts, online scammers see a new avenue to push fake and reimported drugs. These online pharmacies are well-represented in Florida and include a good share of fake pharmacies that have also engaged in money laundering.
A White House report noted that Florida has become a hotbed for this activity, stating:
"Diverted pharmaceuticals are supplied in significant quantities to other regions of the United States by doctors, pharmacists and pain management clinics based in Florida using fraudulent methods. South Florida (Drug Enforcement) Task Force operations are successfully targeting these organizations, and long-term undercover operations are beginning to yield significant results with arrests of high-level multiple clinic owners and a large number of corrupt physicians."
Drugs that are reimported have frequently changed hands up to seven or eight times through countries like China, Vietnam, Bahrain, the United Arab Emirates and Lebanon, skirting FDA oversight. Even if the products turn out to be authentic, because there is no FDA oversight, doctors and patients have no way to check if these drugs were handled properly, contaminated during storage or shipped at unsafe temperatures.
In March the FDA sent letters, including 159 to Florida medical offices, notifying them that they purchased illegal Botox from a supplier that later pleaded guilty to smuggling misbranded drugs into the United States. These online pharmacies have websites that appear completely legitimate and they often appear to use U.S. toll-free numbers, although the actual calls may terminate in the Philippines or another foreign country.
If these illegal distributors and counterfeiters are fooling medical offices, fooling patients may not be difficult.
Unlike the sale of inferior quality counterfeit designer handbags, for example, there are real victims here. The distribution and sale of counterfeit and illegally imported medications can have life-threatening consequences for patients. In November 2004, fake and toxic injections passed off as Botox caused paralysis to four patients near Oakland Park in South Florida. Counterfeit versions of the blood-thinning drug heparin were responsible for the deaths of 149 Americans in 2007 and 2008. Recently, federal officials announced they were investigating the deaths of at least 20 individuals suspected of overdosing on black-market oxycodone.
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Explore all your optionsAuthorities in Florida need to do more to crack down on illegal distributors and doctors who are operating in clear violation of Florida law. State law prohibits the "manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use."
As for the next steps, it is important that state officials take action to enforce existing laws and to give law enforcement more resources to fight this war. If necessary, the Legislature needs to strengthen the laws to protect the public interest.
Patients deserve better.
Steve Pociask is president of the American Consumer Institute, a nonprofit educational and research organization.