Healthy Skepticism Library item: 1404

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Publication type: news

Landers S.
Federal crackdown targets bogus copies of popular drugs:The FDA is devising a plan to halt the influx of counterfeit medicines.
AMNews 2003 Aug 25

Full text:

Washington — Skillfully crafted counterfeits of certain best-selling drugs have turned up in pharmacies across the nation as unscrupulous suppliers find that these fakes have considerable street value.

Thousands of bottles of fake Lipitor were recalled in May and June. Patients also have been found to be injecting bogus versions of anemia drugs Procrit and Epogen and fake Neupogen. And, although no fatalities have been linked to the counterfeits, the pattern is viewed as a threat to patient health.

That’s why physicians likely will play an important role in a new Food and Drug Administration initiative to identify such shams.

From the late 1990s until 2000, the FDA typically investigated between four and six of these cases a year. But in 2002, the number rose to 22. This uptick prompted the agency to announce July 16 its initiative to combat counterfeits. It also will assemble an internal task force on the subject. Preliminary findings are expected next month.

“The sole purpose of this initiative is to develop new and innovative ways to make sure that Americans can continue to have confidence that the drugs they buy are, in fact, the real deal,” said FDA Commissioner Mark B. McClellan, MD, PhD.

But even before the specific marching orders are unveiled, patients and physicians should be vigilant. Although the nation’s pharmaceuticals are among the world’s safest, they are not invulnerable to tampering. And a patient’s inexplicable failure to respond to a medication could be a signal that the bottle in the medicine cabinet does not contain the real thing.

Experts offer a number of signals for which physicians and patients should be on the lookout.

A change in the way a medication affects a patient could indicate a fake or altered medication, said Susan Winckler, RPh, vice president for policy and communications for the American Pharmacists Assn. “If the medication usually makes you light-headed and it [suddenly] doesn’t, then the patient should go right to their physician and to their pharmacist.”

The absence of side effects is not something a patient usually would consider notable, said Winckler. But it could be. “It may be OK because you are developing tolerance, but it is still worthwhile to bring it to everyone’s attention.”

Patients also should be educated to pay attention to any changed appearance in a medication, cautioned Ilisa Bernstein, PharmD, an FDA senior adviser for regulatory policy. Patients might notice that their pills are chipped or a different size or color or that they taste different, she said. “While manufacturers coat pills to certain specifications, counterfeiters … are going to cut corners.”

Advising patients to purchase pharmaceuticals only from legitimate sources also can help cut down on illicit products, Winckler said. Internet purchases are an increasingly popular method of obtaining medications more cheaply and have been one route counterfeits have taken into the country. Winckler advised patients to look for a seal put out by the National Assn. of Boards of Pharmacy, called the VIPPS seal, for Verified Internet Pharmacy Practice Site. It indicates that the sites are licensed in the states where they serve patients and that their facilities have been inspected.

Countermeasures
The counterfeit problem has been particularly severe in Florida, where investigators uncovered the diversion of an estimated $250 million a year in pharmaceuticals.

In a move to prevent more such crimes, Florida Gov. Jeb Bush recently signed the Prescription Drug Protection Act. It increases counterfeiting penalties, requires new standards for licensing wholesale distributors and strengthens pharmaceuticals’ pedigree papers, which constitute a paper trail that accompanies the drugs from manufacturer to pharmacy, making it easier to detect any unauthorized diversion.

Although there are only about a half-dozen major pharmaceutical wholesalers in the nation, there are many more second-tier wholesalers who participate in the system. “Some are legitimate and do a good job of providing the products. Others have sneaked in and don’t really meet the standards,” Winckler said.

The wholesalers who distributed fake Lipitor and are now under FDA investigation also are the targets of lawsuits. One, a class action filed by Paul and Cindy Dumas, who purchased bogus Lipitor at a pharmacy in Rumford, Maine, and another by Pfizer Inc., Lipitor’s manufacturer.

Dr. McClellan said these fake products most likely came from outside the country but were packaged in the United States, according to Dumas’ court papers. The wholesalers were not available for comment.

This theory fits the new criminal model. Counterfeiting in recent years has shifted from supplying bulk drug ingredients to supplying the finished product, according to documents outlining the FDA initiative.

Meanwhile, tracking the product to ensure its safe delivery into patients’ hands is a hot topic. Security experts are exploring whether radio frequency ID tags will save the day, said Jonathan Senft, vice president of consulting for Reconnaissance International, a Denver-based firm working to spot vulnerabilities in the pharmaceutical pipeline. Now being considered as retail surveillance devices to replace bar codes, the tiny computer chips could also be used to track pharmaceuticals from the manufacturer to the medicine cabinet.

However, cost could become an issue, said Winckler. “How [do] we stay a couple of steps ahead of the counterfeiters without creating more of a barrier to people being able to afford medications?”