UPDATE 2-US FDA staff questions J&J sedation device data

* FDA: device meets colonoscopy goal, safety an issue

* Ethicon: device allows clinicians to focus on patient

* Doctors mixed on device's safety, efficacy

* J&J shares close 1.9 pct lower
(Adds reaction by medical community, share price)

By Susan Heavey

WASHINGTON, May 27 (Reuters) - A study of Ethicon
Endo-Surgery Inc's computerized system to help sedate patients
undergoing a colonoscopy showed it was effective but other
factors may have played a role, the U.S. Food and Drug
Administration said in a memo released on Wednesday.

The unit, called Sedasys, monitors patients' vital signs
while intravenously delivering the sedative drug propofol --
made by a variety of manufacturers as a generic and also by
AstraZeneca (AZN.L) under the brand name Diprivan.

Ethicon Endo-Surgery, part of Johnson & Johnson (JNJ.N), is
seeking approval to market the device for use for patients
undergoing a colonoscopy by healthcare providers with no special
training in general anesthesia.

The FDA document was released ahead of a public meeting on
Thursday when the agency will seek recommendations from outside
advisers on whether to approve the product.

While a company study showed Sedasys was superior to current
sedation methods, FDA staff noted "a marked study site effect"
that showed "investigator behavior rather than product
performance may have favored the Sedasys System."

Ethicon Endo-Surgery is also seeking approval for tests to
diagnose upper gastrointestinal tract disorders but data for
that indication did not meet its goals, the FDA said.

Company officials, in a separate document, said Sedasys
provides automated sedation with fewer side effects which could
help ease patients' concerns about colonoscopies and encourage
more people to get the procedure.

Sedasys does not change the actual colonoscopy procedure
itself, but company officials said it helped control dosing and
allowed patients to recover faster.

A company-funded study of 1,000 patients showed patients
sedated with Sedasys recovered in a mean time of 2.7 minutes
compared with 6.3 minutes in patients sedated traditionally.

Various experts cite low compliance among Americans who are
supposed to undergo a colonoscopy, which is generally
recommended for those age 50 or older to detect colon cancer.

But the FDA noted a number of cases where Sedasys patients
became unresponsive or lapsed into deep sedation. It said it
would ask its outside experts whether the device was safe and
effective.

Sedasys monitors patients to help deliver the most accurate
drug dose possible, said Ethicon Endo-Surgery's general manager
for sedation products, Mike Gustafson. He added it would allow
clinicians giving the tests to focus more on patients.

"The device is only going to make conservative drug dosing
decisions ... the clinicians are watching the patient using the
device as a tool," he told Reuters.

The American Gastroenterological Association, which
represents doctors who give colonoscopies, said it supported
computerized sedation and that propofol can be given safely by
doctors and nurses who are not trained anesthesiologists.

Requiring anesthesia specialists "add(s) significant costs
to endoscopic procedures, despite no evidence for improved
patient outcomes for average risk patients," it said.

But the American Society of Anesthesiologists (ASA) said it
was concerned about patient safety with Sedasys, noting propofol
is a potent sedative but inadequate for such tests when used
alone.

Anesthesiologists are also trained to anticipate difficult
parts of a procedure and adjust medication accordingly, unlike
"a machine reacting to a patient's response," Donald Martin, an
anesthesiology professor at Penn State University, told Reuters
on behalf of the ASA.

It is unclear how many doctors' offices, clinics or
hospitals would invest in such a device. Gustafson said it was
too soon to say how much Sedasys would cost but said that there
are 16 million gastroenterological procedures in the United
States each year, including 12 million colonoscopies.

Shares of Johnson & Johnson closed down 1.9 percent at
$54.22 on the New York Stock Exchange on Wednesday.
(Editing by Brian Moss, Dave Zimmerman and Matthew Lewis)