Fake Cancer Drug Found in U.S.

(real Avastin on top/Fake Avastin on bottom)

The maker of the widely used Avastin cancer drug said Tuesday that it is warning doctors, hospitals and patient groups that a counterfeit version of the medicine has been found in the U.S. Tests of counterfeit vials of Avastin showed that they didn't contain the active ingredient in Roche Holding AG's intravenous drug, according to the Swiss company's Genentech unit.

It isn't clear how much of the counterfeit product was distributed in the U.S. or whether it has caused any harm. A Genentech spokeswoman said the company doesn't know if any patients were given the fake drug. The Food and Drug Administration is investigating, and has sent letters to 19 medical practices in the U.S. that the agency says buy unapproved cancer medicines and might have bought the counterfeit Avastin. An FDA spokeswoman said it hasn't received any reports of patient side effects that appear to be linked to the counterfeit product. Most

Americans don't question the integrity of the drugs they rely on. They view drug counterfeiting, if they are aware of it at all, as a problem for developing countries. But the latest incident, which follows the appearance of other fake drugs in the U.S.—including counterfeits of the weight-loss treatment Alli and the influenza treatment Tamiflu—suggests it is a growing risk, especially as more medicines and drug ingredients sold in the U.S. are made overseas. In addition to the specter of fake medicines, U.S. drug makers are confronting their own shortcomings. Companies including Johnson & Johnson have had to shut down manufacturing plants due to quality problems.

Earlier this month, Pfizer Inc. said it recalled about a million packs of birth-control pills because improper packaging could raise the risk of unplanned pregnancies. Roche still is testing the vials of counterfeit Avastin to see what ingredients they contain, but the Genentech spokeswoman said: "It's not Avastin. It's not safe and effective, and it shouldn't be used."

Genentech said it is asking health-care providers to report any suspected counterfeits to the FDA's Office of Criminal Investigations. Avastin belongs to a class of cancer therapies that interferes with the development of new blood vessels that tumors need to grow. The pricey drug, often used with chemotherapy, is for certain patients with colon, lung and other cancers.

The drug was at the center of a controversy last year, because the FDA withdrew approval for its use for breast cancer, angering many patients. A 400-milligram vial of Avastin—the size that was counterfeited—costs $2,400, according to the Genentech spokeswoman. Last year, Genentech's sales of Avastin in the U.S. generated more than $2.5 billion, the spokeswoman said. Many patients receive it intravenously, typically in a hospital or doctor's office, every two or three weeks for as long as a year.

"Most [cancer] doctors in an average workweek will be using it. It is a commonly used drug," said Leonard Saltz, who runs the colorectal oncology section at Memorial Sloan-Kettering Cancer Center in New York. Dr. Saltz, who also chairs the pharmacy committee monitoring the safety of Sloan-Kettering's drug supply, said the Avastin news will prompt doctors and hospitals to double-check their sourcing of the product and make sure their supplies are safe.

Experts say counterfeits are a relatively small but still serious problem for the nation's drug supply. In the U.S., most prescription medicines are distributed by authorized suppliers, who buy them from their manufacturers and assure their integrity. Pharmacies, too, put pressure on the distributors to ensure quality. Still counterfeits can enter the drug supply through unauthorized distributors and Internet pharmacies that try to turn a quick profit selling the inauthentic products.

Doctors and patients might not know they are using a counterfeit if it doesn't cause harm but simply fails to work. The counterfeit Avastin was packaged in boxes and vials whose markings were clearly different from the authentic product, according to the Genentech spokeswoman. In the U.S., boxes of authentic Avastin are labeled in English, say they were made by Genentech and have a six-digit lot number with no letters. The counterfeit boxes had writing in French, identified Roche as the manufacturer, and had lot numbers on the boxes or vials starting with B86017, B6011 or B6010.

Roche first learned there might be a counterfeit problem when an unnamed foreign health authority notified the company in December of inauthentic Avastin made overseas and said it was investigating, the Genentech spokeswoman said. Later, the FDA warned the company.

The FDA said it was alerted by the Medicines and Healthcare Products Regulatory Agency in the U.K. On Friday, the FDA sent letters to 19 medical practices, mostly in California, that the agency said had bought medicines from the suppliers of the counterfeit Avastin.

The two-page letters identified the suppliers as Quality Specialty Products, which the FDA said also might be known as Montana Health Care Solutions. The letter said that QSP's products are distributed by Volunteer Distribution in Gainesboro, Tenn.

"A high percentage of these products are injectable cancer medications whose quality could be adversely affected if they are not stored or transported under specific temperatures," the letter added. QSP and Volunteer Distribution couldn't be reached for comment Tuesday night, nor could 17 of the 19 medical practices.

"I did not have the Avastin they were referring to," said Naresh Gupta, a Plano, Texas, oncologist who received the FDA's letter Monday. He said he purchased Avastin for his practice from a large national drug distributor that wasn't named in the FDA's announcement. A second doctor, Raymond Heung, of San Diego, said he didn't know anything about the Avastin problems or the FDA letter.

In its letter, the FDA asked the medical practices to "cease using and retain and secure all remaining products" from the suppliers. It also issued a general warning to medical practices asking them to "stop using" any products they might have from the two companies and report any suspect items that the companies supplied.

The Genentech spokeswoman said none of the suppliers identified by the FDA are authorized to distribute Avastin. "Genentech limits the distribution of many of its products and only sells its products directly to a defined number of fully licensed and contracted wholesalers and specialty distributors," she said.

Counterfeiting has historically been more of a problem outside the U.S. Counterfeit Avastin was injected into the eyes of 116 patients at a Shanghai hospital, resulting in an outbreak of complications, hospital officials reported last year in a letter to the New England Journal of Medicine.

The active ingredient in Avastin is sometimes used to treat macular degeneration, a disease that causes vision loss, though it isn't approved for that use in the U.S. Concerns about counterfeit drugs sold in the U.S. have grown as more products and their ingredients are made abroad. The FDA has been issuing warnings about counterfeits on average once or twice a year. In 2010, fake versions of the over-the-counter weight-loss drug Alli were being sold over the Internet.

The counterfeit versions didn't contain the active ingredient in Alli and instead contained sibutramine, the active ingredient in the prescription-strength weight-loss drug Meridia, which has since been removed from the U.S. market because of concerns the drug increased the risk of heart attacks.

Also in 2010, the FDA warned consumers that a product sold as "Generic Tamiflu," an influenza treatment, was actually a counterfeit containing a penicillin-like antibiotic, rather than flu-fighting antiviral drugs. And a Belgian man pleaded guilty in a U.S. court last year to selling $1.4 million worth of fake or misbranded drugs, including potentially phony Viagra and Lipitor, both Pfizer drugs, over the Internet.

U.S. customs agents and regulators are spot-checking drug imports with increasingly sophisticated laboratory equipment, but the growing volume of shipments has made it "increasingly difficult for us to regulate our own supply chain," said Tom Woods, of Woods International LLC, a consulting firm that advises on avoiding drug counterfeiting. SOURCE: Jennifer Corbett Dooren, Jonathan D. Rockoff and Christopher Weaver