Radiation Machines Treating Brain Cancer

Brain Cancer Patients in France and U.S. May Be Contacted Due to Error in
Radiation Machines
Thursday, June 14, 2007 1959 PDT

PARIS, France -- Hundreds of brain cancer patients in France and perhaps
others in the United States may be contacted about their radiation
treatments from malfunctioning machines, which were ordered shut down by the
French government after a manufacturer's warning.

The maker of the equipment, Brainlab of Munich, Germany, downplayed the
risks and the company's founder said it involved a small targeting error
that was unlikely to cause problems for patients. However, a company
notification sent to a U.S. clinic warned the problem could cause "injury or
death."

Brainlab officials said they believed the malfunction occurred in just seven
models in use worldwide. Four hospitals in France, two in the United States
and one in Spain have the equipment, but the company would not name the U.S.
hospitals. Brainlab would only say that U.S. government health authorities
and the affected U.S. hospitals were notified.

A company official said the hospitals were in Ohio and Washington state.

The Cleveland Clinic confirmed that it is the Ohio hospital that uses the
BrainLab machine. The hospital discontinued use of the machine after being
notified of the problems last week, spokeswoman Eileen Sheil said.

Martin Weinhouse, a physics expert at Cleveland Clinic, said the problem
involves a small aiming error that can occur when Brainlab's Novalis system
is used with another manufacturer's head frame, a ring-shaped device that
circles the head and is used in delivering radiation.

Weinhouse said the error involves a deviation of about 1.25 millimeters,
which is similar to variations inherent in the delivery system anyway and he
did not believe it would lead to serious problems.

Brainlab founder and chief executive officer Stefan Vilsmeier told The
Associated Press that because doctors typically allow a certain margin of
error in targeting a tumor with radiation, "We don't expect any problems
with the patients."

A copy of the notification sent to hospitals and dated June 4, was obtained
by the Associated Press. It said the malfunction meant the "patient is set
to an unintended position" when receiving radiation treatment and added:
"This may cause serious injury or death to the patient."

The Food and Drug Administration regulates radiation therapy, but
spokeswoman Julie Zawisza said the agency had no knowledge of the problem.
FDA rules require that manufacturers promptly notify the agency of serious
problems that could affect patient health.

Dr. Georges Noel, a radiotherapy expert at the Paul Strauss cancer center in
Strasbourg, said machine malfunctions were potentially harmful.

"A mistargeted machine could irradiate healthy brain tissue ... It could
kill healthy tissue," Noel said. Whether this would have a large or small
effect on the patient depends on the part of the brain affected, he said.

Some 550 Brainlab radiotherapy machines are in use worldwide _ the largest
number of them in the United States.

Valley Medical Center in the Seattle suburb of Renton, Wash., was notified
by Brainlab on June 5 and has discontinued its use of the machine, spokesman
Perry Cooper said.

About 70 patients were treated with the machine in the past two years at
Valley Medical, Cooper said, adding doctors were reviewing patients' records
and notifying them of the defect. The hospital has not seen any problems
with patients, Cooper said.

In France, where there has been a rash of problems with radiotherapy, the
Health Ministry this week ordered use of four of the country's eight
radiotherapy machines suspended indefinitely following the warning that they
were not targeting properly. All four were Brainlab models.

Radiotherapy treatment involves a one-time blast by a high-energy X-Ray that
is aimed from several sources and focused on one point to kill the tumor. It
typically has a margin of error of 0.8 millimeters when used on brain
tumors.

In the malfunctioning French machines, the margin was found to have
increased to 1.25 millimeters, Brainlab said in a statement.

"This security margin is always used to avoid critical organs: very
important parts of the brain such as those that control sight," said Dr.
Christian Carrie, coordinator of radiotherapy at the Leon Berard Cancer
Center in Lyon.

Carrie said that with a security margin, "we cannot be sure, but we can
hope" to avoid killing healthy brain tissue "even if there is a problem with
the targeting of 1 millimeter."

Brainlab sent out its notification after it identified a calibration error
in a new machine in Spain, Vilsmeier said. That machine has not yet been
used on patients.

The problem was the second in France involving Brainlab machines in recent
months. In April, 145 patients received an improper dose of radiation from
Brainlab equipment in Toulouse in southern France. The company blamed the
problem on a "calibration error" and French nuclear safety officials are
investigating.

Brainlab says that problem was not connected to the latest malfunction with
the radiotherapy machines.

Four hospitals, in Nancy, Tours, Montpellier and Paris, shut down their
radiotherapy machines Monday and an analysis of the machines has begun.

The hospitals have also begun tracking down all patients who may have
received treatment from the malfunctioning machines, a number that may top
620, reported Le Parisien newspaper.

Brainlab is offering a software update that should take care of the problem,
Vilsmeier said.

In 2004 and 2005, 24 patients in Epinal received as much as a 30 percent
overdose of radiation while undergoing prostate cancer treatment. Four of
these patients died, and their families are suing the hospitals, claiming
that the deaths were a result of the overdoses.

A 32 year-old woman died of complications after receiving a radiation
treatment to an area 10 times the size she should have, in Lyon in 2004.

In both the Epinal and Lyon incidents, hospitals blamed the problems on
human error.

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