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U.S. Department of Health and Human Services

Drugs

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Cracking Down on Health Fraud

By Michelle Meadows

On April 19, 2006, the Federal Trade Commission (FTC) led a massive "Hispanic Multimedia Surf" to identify potentially fraudulent advertising aimed at Spanish-speaking consumers. More than 160 participants from government agencies and Hispanic consumer and student groups "surfed" the Internet, Spanish radio and television broadcasts, and print media for deceptive advertising in the areas of credit, work opportunities, and health.

"The FDA's role in the surf was to focus on unapproved products with claims to cure, treat, or prevent serious diseases such as diabetes, cancer, HIV/AIDS, and heart disease," says Gary Coody, national health fraud coordinator in the Food and Drug Administration's Office of Enforcement. More than 30 Spanish-speaking employees from the FDA's headquarters in Rockville, Md., and 14 FDA district offices nationwide and in Puerto Rico participated.

The FTC released results of the project in September 2006, reinforcing the need for consumers to recognize the signs of health fraud and to communicate with their doctors before using new medical products. Whether an ad runs in English or Spanish, the characteristics of health fraud are the same, according to Coody. A product is promoted as offering some type of health benefit, but the claims have not been scientifically proven. The product may be ineffective or even harmful.

"Because of the sheer volume of fraudulent health products and their accessibility from foreign locations, the FDA has forged partnerships with many federal, state, and international enforcement agencies," Coody says. Here is an overview of recent regulatory actions.

Weight Loss Fraud 

False and misleading claims in weight loss ads are widespread. Since 2003, the member organizations of the Mexico, United States, Canada Health Fraud Working Group (MUCH) have taken more than 700 compliance actions against companies pushing bogus and misleading weight loss schemes. The FDA and the FTC are MUCH members under a Trilateral Cooperation charter agreement between the three countries. The agreement increases communication and collaboration among the three countries in the areas of drugs, biologics, medical devices, food safety, and nutrition.

As part of the MUCH weight loss initiative, the FDA sent Warning Letters to 25 firms that were promoting products with false weight loss claims. The FDA recently warned consumers not to use Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement. Both products are made in Brazil by Fitoterapicos and Phytotherm Sim. These products may contain prescription drug ingredients that could lead to serious side effects or injury. The FDA has increased efforts to prevent importation of the products. Consumers are advised not to use Emagrece Sim and Herbathin and to return them to suppliers.

Sexual Enhancement Supplements 

In July 2006, the FDA warned consumers not to buy several drugs that were promoted and sold on Web sites as dietary supplements for treating erectile dysfunction (ED) and for enhancing sexual performance. The products are Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, and 4EVERON. Marketed as dietary supplements, they are really illegal drugs that contain ingredients not mentioned in the labeling.

Chemical analysis by the FDA revealed that Zimaxx contains sildenafil, the active ingredient in the prescription drug Viagra, which is approved to treat ED. The other products contain chemical ingredients that are similar to either sildenafil or vardenafil. Vardenafil is the active ingredient in Levitra, another drug approved by the FDA to treat ED.

These ingredients could interact with nitrates in some prescription drugs such as nitroglycerin and could lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The FDA encourages consumers with ED to seek guidance from a health professional before buying any products to treat it.

‘Natural Healer' Convicted 

In August 2006, a federal judge sentenced John E. Curran to 12.5 years in prison for fraud and money laundering. Promoting himself as a natural healer and posing as a medical doctor, Curran operated the Northeastern Institute for Advanced Natural Healing in Providence, R.I. He made false claims about his qualifications, educational background, and training.

Curran sold bogus products called "E-water" and "Green Drink." In promotional materials, Curran claimed to have cured people of cancer. One 17-year-old girl with ovarian cancer reportedly drank only Green Drink, a powdered vegetable drink, in the last weeks of her life.

In other instances, Curran used scare diagnosis tactics so that he could prescribe the phony cures to healthy people. Curran sold about 1.4 million dollars' worth of treatment and products after making his false diagnoses. He told patients they had "live parasites" in their blood, reduced blood cell counts, and ruined immune systems.

In 2005, the Rhode Island Department of Health suspended Curran's health care practice. The FDA and the U.S. Attorney's Office confiscated equipment from Curran's office for misuse of medical devices and other offenses. This case was jointly investigated by the FDA's Office of Criminal Investigation, the Internal Revenue Service, the U.S. Postal Inspection Service, and the Rhode Island Department of Health.

Influenza Scams 

Consumers should be aware that there have been cases involving contaminated, counterfeit, and subpotent influenza products. The FDA, with the U.S. Customs and Border Protection Service, has intercepted products claiming to be a generic version of the influenza drug Tamiflu (oseltamivir). But the products really contained vitamin C and other substances not shown to be effective in treating or preventing influenza.

In January 2006, a licensed practical nurse was sentenced to nine months in prison for running unauthorized influenza vaccine clinics at Augsburg College in Minneapolis. She also was ordered to pay $4,598 in restitution to the victims. The director of security at the school reported to Minneapolis Police that a woman was administering influenza shots to students and faculty members for $20 per shot without authorization by the college.

Investigators analyzed the vials that were seized from the nurse, and found that the labeling and packaging were consistent with authentic flu vaccine, but two of the vials were diluted with saline solution, which lowers the quality and effectiveness of the vaccine.

In 2005 and 2006, the FDA issued Warning Letters to marketers of bogus influenza products claiming to prevent the bird (avian) influenza and other forms of influenza. These sites claimed to sell products that "kill the virus," among other claims. While there are vaccines to protect against seasonal influenza, there are no vaccines for preventing or treating avian influenza in people. There are also no drugs approved for treating the specific symptoms of bird influenza. In 2006, the FDA's Center for Devices and Radiological Health issued eight Warning letters to firms that were selling masks on the Internet that claimed to prevent or cure avian influenza.

 Other Fraudulent Products

  • "The Antidote." The FDA sent a Warning Letter to a foreign-owned Web site touting an unapproved product, The Antidote. Purportedly derived from the blood of crocodiles, the Antidote was promoted as a drug, with claims that it can treat cancer, AIDS, and other life-threatening diseases. The FDA issued an Import Alert intended to prevent all shipments of the Antidote from entering U.S. borders.
  • "Viralsol." A firm's Web site claimed that Viralsol could treat herpes and HIV/AIDS. Patients were instructed to take varying amounts of Viralsol based on their viral load. The FDA considers Viralsol to be an unapproved new drug, Coody says.
  • Fraudulent fruit. In 2005, the FDA sent Warning Letters to 29 businesses making unproven health-related claims about fruit products on their Web sites and on product labels. The companies marketed dried fruit, fruit juice, and juice concentrate for treating and preventing cancer, heart disease, arthritis, and other diseases.
  • Unapproved "cancer treatments." In August 2006, the FDA announced that a federal District Court in Newark, N.J., ordered Lane Labs of Allendale, N.J., to pay refunds to people who bought BeneFin, MGN-3, and SkinAnswer between Sept. 22, 1999, and July 12, 2004. BeneFin, produced from shark cartilage, was promoted as a treatment for cancer; SkinAnswer, a glycoalkaloid skin cream, was marketed as a treatment for skin cancer; and MGN-3, a rice bran extract, was promoted as a treatment for cancer and HIV, the virus that causes AIDS.
  • Unapproved devices for autism. In 2004, FDA investigators recovered ozone generator machines from the Edelson Center for Environmental and Preventive Medicine in Atlanta. Stephen B. Edelson promoted an ozone generator device and other alternative therapies as cures for autism. Some marketers of ozone generators claim that inhaling ozone can "detoxify" the body or stimulate the immune system. According to the FDA, ozone is an unapproved drug. This toxic gas can cause lung damage and other health problems. Edelson's medical license was revoked by the Georgia Medical Board. This case was jointly investigated by the FDA's Atlanta District Office, the FDA's Office of Criminal Investigations, the Georgia Medical Board, and the Georgia Drugs and Narcotics Agency.

 Health Fraud Red Flags

To avoid becoming a victim of health fraud, consumers should learn how to evaluate health-related claims. "I advise consumers to avoid web sites that offer quick and dramatic cures for serious diseases," says David Elder, director of the FDA's Office of Enforcement. "Recognize the red flags and always consult a health professional before using any product or treatment."

Consumers should be wary of

  • Statements that the product is a quick and effective cure-all or a diagnostic tool for a wide variety of ailments. "Beneficial in treating cancer, ulcer, prostate problems, heart trouble, and more …"
  • Statements that suggest the product can treat or cure diseases. "Shrinks tumors, cures impotency …"
  • Promotions that use words like "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy."
  • Text that uses impressive-sounding terms like these: "hunger stimulation point" and "thermogenesis" for a weight loss product.
  • Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results. "After eating a teaspoon of this product each day, my pain is completely gone …"
  • Limited availability and advance payment requirements. "Hurry! This offer will not last."
  • Promises of no-risk money-back guarantees. "If after 30 days you have not lost at least four pounds each week, your uncashed check will be returned to you."
  • Promises of an "easy" fix.

Sources: The Federal Trade Commission, the U.S. Food and Drug Administration

Diabetes Health Fraud 

Over the past year, the Mexico, United States, Canada Health Fraud Working Group (MUCH) has focused enforcement and consumer education efforts on fraudulent products to treat diabetes. In October 2006, MUCH member agencies announced that they had taken nearly 200 compliance actions against companies promoting bogus products that provide false hope to people with diabetes. The compliance actions include Advisory Letters, Warning Letters, and import refusals. Many of the actions are still pending, but some firms have voluntarily removed false claims and discontinued sales of the bogus products.

Regulatory authorities in Canada and Mexico also released educational materials for consumers and announced the compliance actions they took against bogus diabetes treatments.

 

Here are some examples of unproven claims to treat diabetes:

  • Drop your blood sugar 50 points in 30 days, or it's free …
  • Eliminate insulin resistance.
  • Prevent the development of type 2 diabetes.
  • Reduce or eliminate the need for diabetes drugs and/or insulin.
  • Prevent diabetes-related eye disease, damage to cells caused by poor blood sugar control.
  • Take the natural alternative to…the diabetes drug metformin.

For more information on MUCH actions, visit the Health Canada Web site.

 

 Home Genetic Tests

In July 2006, the FDA, the Federal Trade Commission, and the Centers for Disease Control and Prevention (CDC) alerted consumers about the facts surrounding direct-to-consumer marketing of genetic tests. Genetic tests examine genes and DNA to see whether they indicate particular diseases and disorders.

Some companies claim their tests can screen for diseases, evaluate health risks, or suggest treatments. But genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a trained health care professional or a genetic counselor. Home genetic tests are not a suitable substitute for a medical checkup.

"At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription" is available on the Federal Trade Commission Web site.  

Search the FDA's Over the Counter Tests Database  to find out whether an over-the-counter genetic test is FDA-approved/cleared.