Fake Cancer Drug Found in U.S.
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.
Swiss drug maker Roche said it is warning
doctors, hospitals and patient groups that a counterfeit version of its
widely used Avastin cancer therapy was found in the U.S. Jonathan
Rockoff has details on The News Hub. Photo: AP
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."
Zuma Press
The maker of the widely used
Avastin cancer drug said that it is warning doctors, hospitals and
patient groups that a counterfeit version of the medicine has been found
in the U.S.
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.
—Jennifer Corbett Dooren contributed to this article.
Molecule:
SOURCE: http://www.kidneycancerinstitute.com/Bevacizumab.html
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