Stanford Reverses, Begins Investigation of 2 Doctors

San Francisco Gate

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Stanford Reverses, Begins Investigation of 2 Doctors

Surgeons allegedly failed to reveal problems

William Carlsen, Chronicle Staff Writer

Friday, September 8, 2000

©2000 San Francisco Chronicle

http://www.sfgate.com/cgibin/article.cgi?file=/chronicle/archive/2000/09/08/MN91532.DTL&type=health

STANFORD—Stanford University is investigating allegations that two prominent surgeons affiliated with its medical center made errors and omitted serious medical complications in articles they wrote about new surgical techniques.

The investigation comes in response to mounting evidence that Drs. Camran and Farr Nezhat did not include some complications in two journal articles in 1991 and 1992 that described a controversial new procedure they developed to treat endometriosis in women. There are also new allegations that the doctors may have made errors in a third article published in 1996 about an entirely different procedure.

Stanford general counsel Debra Zumwalt said yesterday that the university will also appoint an independent third party from outside the university to review the Nezhats’ underlying research.

The investigation marks a dramatic shift for Stanford officials who said earlier this year that it was not their responsibility to look into allegations involving operations that were performed in Atlanta before the Nezhats came to Stanford in 1993.

The university has insisted that it has "thoroughly investigated" allegations against the Nezhats in 1996, ‘97 and ‘99 and found no improper conduct.

‘INSTITUTIONAL INTEREST’

But Zumwalt said yesterday that "even though the (1991) operations were not done at Stanford, we have an institutional interest in whether there is integrity in the research done by those connected to the university."

The Nezhats are nationally acclaimed pioneers in laparoscopic surgery, a technique that uses miniature video cameras, laser scalpels and long-stemmed instruments worked through tiny incisions in the body.

The two surgeons are directors of the Stanford Endoscopy Center for Training and Technology, a leading educational center that teaches advanced surgical techniques to doctors from across the country.

Farr Nezhat, however, recently ended his affiliation with Stanford as a clinical professor in the school’s gynecology and obstetrics department. He recently joined the faculty at Mount Sinai Hospital in New York City.

ATLANTA OPERATIONS SCRUTINIZED

The university’s investigation will focus on the controversial series of operations the Nezhats performed on 16 female patients at Atlanta’s Northside Hospital in 1991.

Those operations used a new laparoscopic technique to treat endometriosis of the rectum. Critics have called the procedures used in the surgeries "barbaric" and "bizarre" experiments that apparently were conducted even before they were tested on animals.

In court documents filed recently in an Atlanta malpractice lawsuit, Farr Nezhat acknowledged that he made a number of errors in one of the articles describing the procedure. He insisted, however,

that the errors were harmless oversights and not fabrications.

Zumwalt said yesterday that the university is also investigating whether the Nezhats accurately reported data in a third journal article published in a 1996 issue of Surgical Laparoscopy and Endoscopy.

In that article, written while the Nezhats were at Stanford, the gynecological surgeons reported that they had fully examined tissue necessary to determine the extent of the spread of cancer in a 47-year-old patient they had operated on at the university in 1994.

The patient, a practicing gynecologist, said the Nezhats misreported her surgery in the article, and she recently filed a complaint with the university.

A Chronicle review of her medical records shows that Camran Nezhat failed to remove lymphatic tissue on the same side of the woman’s pelvis where earlier cancer was found, indicating that the exploratory surgery may not have been complete and may not have been described accurately in the journal.

The Nezhats and their attorneys could not be reached for comment yesterday.

ALLEGED OMISSIONS

The Atlanta malpractice lawsuit was filed by a Southern California woman, Stacey Mullen, who was operated on by the Nezhats in 1991 using the same surgical technique used on the 16 women.

Mullen claims that her operation resulted in serious complications leaving her with a colostomy. She also claims the Nezhats omitted her case from their journal articles because of the complications she suffered.

The Nezhats have denied her charges.

Their 1991 and 1992 journal articles describing the series of surgeries performed on the 16 patients, also published in Surgical Laparoscopy and Endoscopy, claimed virtually no complications.

A recent Chronicle review of the 16 patients’ charts, however, found substantial discrepancies between the records and the data reported in the Nezhat articles, including much greater blood losses and operating times and complications that were not reported.

In his sworn affidavit filed in Mullen’s malpractice case, Farr Nezhat admitted that two of the 16 patients did not even have the surgical procedure described in the article.

He also said other errors were also made in reporting the data. "I did not supervise the collection and tabulation of the data for the article as closely as I should have," he said.

RECORDS WILL GO PUBLIC

Zumwalt said Stanford officials are carefully reviewing Nezhat’s affidavit and other documents in the malpractice case, and they also plan to request a copy of all the patients’ records from the court.

‘’People can then look at the underlying records and draw their own conclusions," she said.

The judge in the case said last week that he intends to make the medical records a part of the court record—which will make the records available to the public—as soon as he completes his review of them.

Zumwalt also said the university is attempting to identify all the journal articles the Nezhats have published while at Stanford.

"Any time there are discrepancies," she said, "there is a concern about whether they form an isolated incident."

E-mail William Carlsen at wcarlsen@sfchronicle.com.

©2000 San Francisco Chronicle Page A1

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