CONSUMER CORNER: Where DID your medicine come from? ~ By Alan Marx

Do you know where your medicine came from? ...and do you want pasta with that?

As we age most of us learn far more about medicine than we ever wanted to know. We also discover how expensive pharmaceuticals are. Unless you are very lucky, the cost of the medicines you need to stay healthy and alive is a significant part of your budget. Scammers know this, and they are active in this area trying to relieve you of your money, often plying their tricks on the internet, over the telephone, and through the mail.

Pharmacy Fraud

The federal Food and Drug Administration (“FDA”) has a Cybercrimes Investigation Unit that focuses on illegal acts involving prescription drugs done with the use of a computer and a network.

In March 2013 a special team was created in the FDA’s Office of Criminal Investigations to track down the operators and suppliers of web sites that illegally sell prescription medicines. Many of these sites claim to be Canadian pharmacies, but most are not legitimate pharmacies. The drugs they sell often are not made in Canada, but originate in other parts of the world, including Southeast Asia, the Middle East, North Africa, and South and Central America, where they are may be manufactured without regulation or supervision. Some of these drugs are potentially dangerous counterfeits, without the claimed and essential active ingredients or with undisclosed ingredients. They may have never been approved for the intended use. Taking these drugs could endanger your health and could be life-threatening.

Some of the drugs may be legitimate, but they were obtained by the seller through theft. Unlike purchases from legitimate on-line pharmacies, which are regulated the same way as your corner drugstore, a consumer who tries to save money by purchasing from these on-line “Canadian” style pharmacies has no way to know what he or she is getting. (Incidentally even if an on-line Canadian pharmacy is legitimate, the FDA advises that, in general, it is unlawful for a U.S. citizen to import prescription medicine from other countries.)

In June 2013 the FDA, working with international regulatory and law enforcement agencies, seized 1,677 pharmacy websites and shut them down. The common thread for many of the websites was that they represented themselves as “Canadian pharmacies.” They described the medicines they sold as “brand name” or “FDA approved,” both of which were untrue, and in some cases used web names intended to trick customers. Two examples cited by the FDA were "www.walgreens-store.com“ and “c-v-s-pharmacy.com.

A representative of the FDA said an estimated 10,000 sites were believed to be part of this network and at that time 40,000 to 60,000 domain names could be tied to these pharmacies, although the number changes constantly. In some cases, the suspects who operated these sites were turned over to authorities in the country in which they were based, and in other cases they are extradited to the United States for prosecution.

The FDA warned that using these sites pose other risks for consumers, such as identity theft, credit card fraud, and computer viruses. Report suspected criminal activity.

There are legitimate on-line pharmacies that operate on the internet, and they offer convenience and in some cases good prices.

How can you tell if a pharmacy you are considering is legitimate? The FDA says that signs that indicate an online pharmacy is legitimate include: requiring patients to have a valid prescription; providing a physical address in the U.S.; being licensed by a state pharmacy board; and having a state-licensed pharmacist to answer questions. If you have doubts, ask your doctor or your health insurance company before you place an order with an on-line pharmacy.

Phony Diabetes Products

According to the Centers for Disease Control and Prevention, 26 million people in the U.S. (about 8.3 percent of the population) have diabetes, including about 7 million who are undiagnosed. Millions more have higher than normal blood sugar levels, a condition known as pre-diabetes. The percentage of the population with diabetes is even higher for older Americans. 10.9 million Americans ages 65 and older have diabetes — 26.9 percent of this age group.

Whether you have diabetes or not, you probably have heard radio advertisements that promise you can prevent, control, treat, or even cure diabetes without medication by just taking a pill that you can obtain without a prescription. One current advertisement claims that one of the main ingredients in its pill is found in the kitchen of most households (that would be cinnamon), although the advertisement then ends with a disclaimer saying that its product is not intended to treat, cure, etc., any disease or condition.

Products promising to improve the life of people with diabetes are flooding the market. The FDA warns against the use of these products, for two reasons. First, the ingredients found in some of the products may be harmful. Second, these products may lead diabetics to delay proper medically necessary treatment, which can lead to serious health complications that result in amputations, kidney disease, blindness, and death.

In July 2013 the FDA warned 15 companies that their sales of diabetes products violated federal law. The following are examples of some of the claims made for these products: "Lower your blood sugar naturally." "You'll lower your chances of having eye disease, kidney disease, nerve damage and heart disease!" "It can replace medicine in the treatment of diabetes."

The FDA found that some of the products that claimed to be “all natural” treatments contained undeclared, active ingredients that are also found in prescription drugs for diabetes. The presence of these undeclared ingredients is dangerous for consumers, particularly if they are taking other medications or if they are taking a medication that contains the same ingredient. Taking too much of a diabetes medication can lead to a serious drop in blood sugar levels.

Pasta Fraud

While we are on the subject of diabetes and fraud, let’s turn to food. Medicare provides coverage of diabetes screening, supplies, self-management training, and medical nutrition therapy services. Nutritionists who specialize in diabetes management teach people with diabetes to closely monitor their diets. Diabetics are strongly encouraged to read food labels and to limit the amounts and types of carbohydrates they eat. Diabetics also get advice from magazines that report on latest medical research in the field. Those magazines contain advertisements for products that claim to be suitable for diabetics.

For several years pasta sold under the name “Dreamfields” was advertised in one of the leading magazines for diabetics, using the slogan “Healthy Carb Living.” The advertising said that Dreamfields pasta has “the authentic taste and al dente” texture of traditional pasta. Of even greater importance, the advertising, as well as statements on the packaging, claimed that Dreamfields pasta was low-carbohydrate alternative to traditional pasta and that the pasta had a low glycemic index when consumed. (The glycemic index ranks foods from 1 to 100 based on their effect on blood sugar levels.)  Specifically, the makers of Dreamfields pasta claimed that because of their unique manufacturing process, most of the carbohydrates in the pasta were not digested and that the pasta had a 65 percent lower glycemic index than regular pasta.

In 2013 two federal complaints were filed, one in New Jersey and one in Minnesota, alleging that the low carbohydrate claims were false. The defendants were Carrington, North Dakota-based Dakota Growers Pasta and its parent company at the time. According to the Associated Press, the plaintiffs noted a study at the University of Minnesota that showed the people who ate Dreamfields pasta did not have a smaller blood-glucose increase than people who ate regular pasta. The defendants responded that the study was not published in a peer-reviewed journal and was "flawed methodologically."

Nevertheless, after mediation the defendants agreed to settle the class-action lawsuit by paying $5 million to purchasers who bought the pasta after February 2004. Consumers will receive a refund of $1.99 for each box of pasta up to 15 boxes of pasta bought at any store. Reimbursement will be paid for all boxes bought online. In addition, new labeling will be required.

Conclusion

Most of the time we tend to take our medicine and our food for granted. The neighborhood pharmacist is a trusted figure like a Norman Rockwell picture from an earlier era. As the matters discussed above show, we now live in a much more complicated world. Our neighborhood pharmacist now may be a remote voice on the internet or just an email. It is a situation that is ripe for abuse, and abuse has occurred.

The solution is not to stop using the internet or mail order, but it does call for knowing with whom you are dealing. The risks to your health are too great to fall victim to counterfeit or unsafe medicine. In the Dreamfields case, people who tried to do the right thing to control their blood sugar were misled. The protections of government regulation and even of the diabetes watchdogs were not enough. In this instance two private lawsuits opened the door to corrective action. It is only a shame that it took so long.

Alan Marx is a volunteer and Consumer Protection blogger for AARP in Tennessee. Alan practices law and resides in Nashville.