Counterfeit drugs online and from doctors disturb experts, FBI

FBI says La Jolla doctor put patients at risk

SAN DIEGO - The prescription medicine you get online or from your doctor could be fake and deadly, according to industry experts and former FBI agents recently in town for a convention aimed at fighting counterfeit drugs.

Team 10 found out even if one percent of prescriptions on the market are fake, millions of Americans are at risk because so many people take prescriptions.

A graduate student demonstrated one way it's easy to get counterfeit drugs -- he set up a fake pharmacy online that is set to sell counterfeit prescriptions.

"We were up and running in an hour," said Dr. Bryan Liang, the student's professor from the University of California, San Diego.

The fake pharmacy called "No prescription drugs" has a domain name, Facebook page, Twitter account and plenty of willing customers.

"We had an average of 100 hits a month for each of our online pharmacies from 12 countries," said Liang.

Liang's graduate student set up the fake online site to study the massive problem of counterfeit drugs, and how easy it is to push counterfeit pills online. His site could not actually sell drugs, only track the number of hits that came to the site but he said there are hundreds of sites selling fake drugs.

The Scripps Howard News Service recently reported a 2009 crackdown by the Food and Drug Administration on unauthorized online pharmacies led to the seizure of more than 800 packages that included Viagra, the pain reliever Vicodin and antihistamines.

Some of the fake drugs had three times the level of active ingredient they should have, others none. Fillers included drywall, antifreeze and yellow highway line paint.

"You can buy any drug you can imagine," said Liang.

Liang is an expert on counterfeit drugs and the director of San Diego Center for Patient Safety.

Liang, former FBI agents and drug experts met in San Diego last month to try and fight the problem at a one-of-a-kind conference held each year in the San Diego.

Team 10 talked to several industry experts at the conference about the problem they called potentially lethal.

Liang said some people think when they buy drugs online, they are getting real meds for a good deal.

"Just because the label says it's the same doesn't mean it is," said Liang. 

Liang said the drugs are made in other countries, in factories that aren't regulated by the FDA or any other oversight agency.

The Scripps Howard News Service reported the FDA has issued warnings about substandard -- and illegal -- imported versions of the tumor-fighting drug Avastin three times in the past year, most recently shipments of a Turkish version of the drug.

Scripps reported in 2008, there were at least 149 deaths and many more severe allergic reactions to tainted blood thinner imported from China. Other times, officials have seized drugs that include ingredients that have been banned in the U.S. for safety reasons.

"If I don't have to follow laws, it's much cheaper," said Liang.

The World Health Organization estimates that 25 percent of drugs consumed in poor countries are counterfeit or substandard, some international watchdog groups say up to 50 percent of treatments sold in the developing world are fraudulent.

Counterfeit estimates for the U.S. are much lower -- one to two percent of drugs are fake, according to the FDA and the National Association of Boards of Pharmacy. It's assumed by industry experts that federal and state authorities' tighter controls over manufacturing, distribution and retail sale of prescription and over-the-counter drugs reduce the incidence of fraud.

But with more than four billion prescriptions filled in the United States each year -- worth an estimated $310 billion -- even one percent translates to four million packages that either have no active ingredient or an insufficient amount, or that contain useless or even toxic fillers.

La Jolla Dr. Joel Bernstein pleaded guilty this year to giving the unapproved cancer drug, Mabthera, to his patients.

The criminal complaint said he billed Medicare $1.2 million dollars.

The drugs were tested and shown to have the same ingredients as the approved drug and Bernstein's patients were not at risk of dying, according to the FBI.

Bernstein declined to be interviewed for this story through his attorney.

The FBI released a statement regarding the Bernstein case that said in part, "The cases involving Dr. Bernstein and his practice are the latest example of an alarming nationwide trend that potentially puts patients at risk by exposing them to foreign drugs-particularly injectable chemotherapy drugs-that are not vetted by the FDA. Agency officials have described the trend as an "epidemic of unapproved and counterfeit drugs."

John Roth, director of the FDA's Office of Criminal Investigations, the lead agency on the case, said, "When medical professionals decide that patient safety is less important than finding a great deal on pharmaceutical products from foreign countries and unknown suppliers our nation's pharmaceutical supply chain is at risk and patients are vulnerable.  We hope this message is heard loud and clear within the medical community-you will face criminal prosecution if you engage in this type of illegal activity."

Liang said it's a big risk to sell drugs not approved by the FDA.

"If it was the same thing," Liang said, "how come you didn't report this? How come you didn't engage the entire oncology community in San Diego. Oh, I can find better source cheaper, better for my patients. It's because you want to make money."

Liang said, another problem, other doctors buy fake drugs for cheap with little or no active ingredients and prescribe them to patients.

Liang gave an example of breast cancer patient given counterfeit drugs, who dies. "Aw, you must have succumbed from the disease," said Liang. "But it's not true - you didn't succumb to the succumbed to the fact that there is no real medicine that you were being provided."

The National Crime Prevention Council and The U.S. Food and Drug Administration lists the following threats to health caused by counterfeit drugs:

--Toxic effects: The counterfeit drugs contain ingredients that, if ingested or injected, can cause health problems.

--Unintended effects: Some counterfeits are presented as substitutes for other drugs. For example, counterfeiters recently emptied bottles of the anti-psychotic drug Zyprexa and filled the bottles with aspirin. The drugs had no therapeutic value.

--Ineffective treatments: Some fake drugs contain some active ingredient, but are sub-potent. Sub-potent drugs are especially dangerous in the treatment of illnesses like HIV and malaria.

--No active ingredients. Some drugs are just chalk or water. A counterfeit version of Serostim, a growth hormone used to treat AIDS patients, was found to have no active ingredient.

The worst part, Liang said, patients can't tell the difference.

"They'd have to go through a laboratory. The stuff looks perfect," said Dr. Liang.

Some counterfeit copies of drugs are impossible to detect without a laboratory test. But the National Association of Boards of Pharmacy offers several red flags for consumers concerned that the drug they've been given is not legitimate.

The group advises consumers to watch out for the following:

--Packaging that appears to have been opened or labels that appear different from those seen in the past;

--Medicines that are cracked or chipped or have a different color or shape than you're used to;

--A medicine that has a different taste or texture than you've previously experienced;

--Adverse effects after taking the medicine -- side effects that you have not had before or that are not mentioned on warning labels.

If you suspect you have a fake drug, contact the FDA's Medwatch program  ( or 1-800-332-1088), or state pharmacy board, report it to the manufacturer or to the pharmacist that dispensed the drug.



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