Wednesday, June 3, 2015

Pharmaceutical Fraud: A Billion Dollar Industry



There probably isn’t anyone who hasn’t received spam email for “lifestyle drugs” such as those commonly used to treat depression, anxiety, weight-loss and erectile dysfunction. While many simply click delete and would never consider buying these drugs or any off the internet, for others it’s become common place and sometimes the only affordable access.

While lifestyle drugs are the most common drugs caught in pharmaceutical fraud investigations, no drugs have been off limits. Many medications from those used to treat diabetes, to HIV and even cancer drugs have been linked to cases in the growing pharmaceutical fraud industry.

Pharmaceutical fraud could be anything from theft of prescription drugs stolen from the manufacturer to thefts at local pharmacies and also includes drug counterfeiting by wholesalers and other as well as fake drugs being sold over the internet. Sometimes these counterfeit drugs make their way into local legitimate pharmacies and are then passed on to consumers with consequences that pose serious health risks and even death.

There is no denying that the pharmaceutical industry is big business generating close to 180 billion a year and fraud in this industry is an ever growing concern. Federal officials acknowledge that it has been a challenge to know the full extent of the problem of counterfeit drugs. But many believe that it poses a growing danger. With medication costs on the rise, consumers are turning to the internet, foreign “pharmacies” and the black market for lower prices. Criminal cases have tripled over the last several years.   

Counterfeiters are more active than ever and are becoming savvier creating drugs that mimic in size, color and shape real prescription medication as well as reproducing packaging almost identical right down to the holograms, to the point where sometimes the only way to tell that the medications are counterfeit is after the damage is done.
This growing problem seems to be affecting all areas of the pharmaceutical industry. 

While there remain many avenues for criminals to sell counterfeit and fake drugs on internet sites as well as bringing in counterfeit drugs from other countries, the evidence from recent seizures of counterfeit drugs suggests that the more serious problem comes from within the United States. The problem, authorities say, is a lax drug distribution system that provides ample opportunities for counterfeit and fake drugs to enter the supply chain.

Prescription drugs often follow a long tangled path before reaching a licensed pharmacy and then the consumer themselves. Pharmaceuticals travel from manufacturers ranging in size from major national companies to tiny operations that may consist of nothing more than a few staff and a small office, to re-packagers and then on to pharmacies; moving from one destination to another before landing on a pharmacy shelf.

The greatest opportunity for counterfeiting can come when wholesalers and re-packagers get their prescription drug products from sources other than original manufactures. This is seen frequently when low-priced drugs that are supposed to be used by health clinics or Medicaid programs end up being sold instead for a higher price and used elsewhere.

Drugs that have been outside the regular distribution system are no longer protected by the safeguards for re-packaging, content, and storage, which then can alter the effectiveness and potency of the drug.

Although most wholesalers are legitimate, some are nothing more than fronts used to illegally divert drugs and resell them at a higher profit. As prescription drugs change hands, in some cases, multiple times between the drug makers and patients, counterfeiters have plenty of opportunities to introduce altered and outright fake drugs into the system.

The same tactics are often used by companies that buy prescription drugs in bulk quantities from manufacturers at a discount, and then sell them to hospitals, nursing homes and other healthcare facilities. These companies may buy more than they need and sell the rest to wholesalers. The wholesale market for prescription drugs in wrought with corruption and in many instances when counterfeit drugs have been entered into the supply chain; it’s been through a dishonest wholesaler.

The FDA has acknowledged that is not just wholesalers but companies whose sole purchase is repackaging can enter bogus drugs into the supply chain. Many drugs are sold by pharmaceutical manufacturers in bulk. Along the way from drug maker to consumer, pills and other medicines are repackaged into the familiar 30-, 60- or 90-dose bottles that most people buy. This offers one more opportunity for counterfeiters to introduce counterfeit pills.

Yet another way counterfeit drugs enter the system is when prescription drugs are sold to wholesalers by patients who go from doctor to doctor, getting prescriptions, filling them at a discount, and then selling them to street wholesalers.

Drugs too can be diverted from the normal supply chain through thievery. Drugs are hijacked during shipping and then the products sold on the street, on fake internet pharmacies or sometimes sold back to unscrupulous wholesalers.

Legitimate drugs are sold on the Internet from reputable licensed pharmacies. But the internet also provides a vast opportunity for fake internet pharmacies. Some of the fake pharmacy sites provide avenues for entry of counterfeit drugs imported from other countries, most commonly Mexico, Canada and China. These sites are found by bargain hunters enticed by cheaper versions of the medications and advertisements most commonly sent via spam email advertisements.

Fake internet pharmacies have been known to sell consumers contaminated or counterfeit products or products that have not been approved by the FDA. These sites have been known to deliver the wrong product, or just take consumers money and never deliver anything in return. Still others drugs sold are those that have been withdrawn from the U.S. market for safety reasons.

Many are packaged and sent without the original labeling and instructions for use. Some drugs purchased off the internet are nothing more than complete fakes that contain nothing medicinal and are total placebos.  

When these counterfeit drugs end up with consumers by any of the means above it is very difficult to tell prior to ingestion that the drugs received are counterfeit. Investigators may be called in to nursing homes, hospitals and individual consumers because counterfeit drugs caused serious harm and even death to those that have consumed them. Others still may not receive the life saving medications they desperately need. Investigators may be called in to investigate when these situations occur.

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