First appeared in Wall Street Journal
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. A
Miami
Medical Malpractice Lawyer is curious.
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. At
Milwaukee
cancer care, they have not noticed any irregularities yet.
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. A
Miami
Medical Malpractice Lawyer is contemplating what this means.
"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.
