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FDA: Bird flu 'remedies' not so helpful

By Audrey Gruber and Randi Kaye

David Elder
David Elder of the U.S. Food and Drug Administration polices drug frauds and counterfeits on the Internet.


NEW YORK (CNN) -- Type "avian flu" or "bird flu" into an Internet browser, and you will find Web sites selling "generic Tamiflu," herbal cures, and many other ways to fight the illness.

But these products offer little protection against the H5N1 virus that causes bird flu, federal health officials say.

"None of them have any scientific evidence to show that they are safe and effective for the treatment of bird flu," said David Elder, director of enforcement at the U.S. Food and Drug Administration.

In his role at the FDA, Elder polices drug frauds and counterfeits on the Internet. Working with Customs, his agents recently seized 51 shipments of so-called "generic Tamiflu" that was on its way to U.S. consumers from China.

Tamiflu, made by Roche, is the only drug approved in the United States for treating bird flu symptoms.

The agents were tipped-off to the illicit nature of the shipments because there is no generic version of Tamiflu on the market.

When the contents were tested after being seized, it was revealed that the pills contained Vitamin C.

The FDA has sent out at least 28 warning letters to Internet-based companies that claim to offer a cure for or protection from bird flu.

"We've seen counterfeit Gucci and counterfeit Rolex watches. These are counterfeit prescription drugs," Elder said. "People are taking these to protect [against] serious illness. The stakes are high, and our tolerance is zero."

A simple Internet search by CNN reporters turned up other instances of companies marketing products as cures for or protection against bird flu.

One product, Avian RX, appears on a Web site that says "It claims to be the herbal Tamiflu." But the FDA said that claim is not legitimate.

"Making the claim that it is an herbal alternative to Tamiflu is equivalent to a prescription drug claim. I am not aware that anybody has submitted an application to the FDA seeking approval for that claim," Elder said.

When CNN contacted Jared Wheat, president of Hi-Tech Pharmaceuticals, which makes Avian RX, he said his company has no control over the claims made by the distributor on the Web site. He said he chose the name "Avian RX" at random, but that he had changed the name to "Defend RX."

The next day, Defend RX was being offered on the Internet. The name of the product had changed, but not the claims about it. And when CNN ordered "Defend RX," "Avian RX" was shipped.

Asked about this, Wheat e-mailed a reply: "No comment."

In the meantime, the FDA has concerns about the company.

"The manufacturer of Avian RX is under injunction from 2003 for past practices of marketing products without approval by the agency and remains under that injunction," Elder said. "So if this manufacturer was marketing this product with those claims, then it's likely that they are violating court orders for the injunction."

The FDA will not comment on what, if anything, it's doing about Avian RX or Defend RX, saying it can't talk about investigations.

CNN found another company, Hamrick's LLC, using fears of bird flu to market its products. claims that its product, AVN 36, is a "powerful immune system booster to help protect your family against bird flu."

But the company offered no published, peer-reviewed studies to back up that claim.

"It's actually not a cure for bird flu. It doesn't really stop it. At this point, there is no vaccine for the H5N1 virus, the avian influenza," said Gayla Young, the company's marketing director.

So why call it

"When we had the domain name, it's primarily to promote our product the AVN 36," Young said. She said the small print notes that AVN 36 does not cure bird flu.

Elder said consumers will get little more than a credit card charge if they purchase these types of products.

He said consumers can figure out what is real and what is not by following this simple rule: "There are no products currently approved that consumers can purchase over the Internet that are approved for the treatment or prevention of the avian flu."

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