Mark Henderson, Science Editor, in San Francisco
An antioxidant chemical found in tomatoes could be used to treat common causes of abdominal pain such as internal scarring after surgery and endometriosis, new research has suggested.
Lycopene, the bright red pigment that gives tomatoes their characteristic colour, can inhibit proteins that are linked to the formation of abnormal patches of tissue called adhesions, according to a study of cells in culture.
Though the findings are very preliminary, they hint that a diet rich in tomatoes and tomato products, or supplements containing lycopene, might be a promising way of controlling adhesions.
Adhesions are patches of scar tissue or fibrous strands that form on internal surfaces in the abdomen, often connecting two organs or parts of organs together. They are a common side effect of surgery, and they also occur in endometriosis, a condition in which tissue that normally lines the womb grows in other parts of the abdomen. These growths can cause pain, bowel obstructions, bladder problems and infertility.
Related Links
Endometriosis
Food detective: best tomatoes
Abdominal adhesions are commonly associated with tissue damage caused by free radical oxygen molecules, leading a team headed by Tarek Dbouk, of Wayne State University in Detroit, to investigate lycopene because of its antioxidant properties.
The chemical, which is particularly abundant in cooked tomato products such as ketchup and pasta sauces, is already thought to have protective effects against cardiovascular disease and some cancers.
In the study, Dr Dbouk exposed human cells to lycopene in the laboratory, and measured its effect on proteins that serve as markers for adhesion formation. Levels of these proteins were substantially reduced, by as much as 80 to 90 per cent.
Dr Dbouk told the American Society for Reproductive Medicine conference in San Francisco that the results suggest that lycopene – and tomatoes that contain it – could be useful for treating post-surgical adhesions and other conditions such as endometriosis and uterine fibroids.
“What we found in our laboratory study is that lycopene can help with the adhesions that these conditions cause,” he said. “One of the major complications of endometriosis is that it causes inflammation which induces adhesions.
“The inflammation basically causes scarring. What we did was to look at protein markers that could help us trace the activity of the abnormal cells that cause these adhesions. The lycopene worked to reduce the abnormal activity of these cells.
“This means that you would not get the adhesions, which suggests that lycopene could work to mitigate the complications and ailments of endometriosis. So, hypothetically speaking, we might be able to reduce the adhesion effects of endometriosis.”
The study does not show whether lycopene absorbed through the diet would have the same effect on real cells in the human body, but Dr Dbouk said it could be practical to get it in this way. “It is certainly possible that you could get the amount you need from your diet,” he said. “Or if the patient did not like tomatoes, you could give them the lycopene as a supplement.”
http://www.timesonline.co.uk/tol/news/uk/science/article5135497.ece
Sunday, November 30, 2008
Toamtoes, endometriosis and adhesions
Eating tomatoes may help treat endometriosisTimes Online, UK - Nov 11, 2008Adhesions are patches of scar tissue or fibrous strands that form on internal surfaces in the abdomen, often connecting two organs or parts of organs ...Tomatoes could hold key to treat painful condition suffered by women Telegraph.co.ukTomato 'could ease endometriosis' The Press Associationall 13 news articles »
Tuesday, November 18, 2008
The fate of Stacey Mullens
Stanford Surgeon's Procedures Raise Ethical and Legal Red Flags
Supporters say Camran Nezhat is a miracle worker -- critics call his operations bizarre and barbaric
With a white surgical mask dangling rakishly below his chin, Dr. Camran Nezhat looks every bit the part in his promotional video: medical pioneer, gifted surgeon, millionaire inventor of operating room tools. The Stanford clinical professor, recruited from his lucrative Atlanta practice, is a rainmaker for the university's medical center and obstetrics and gynecology department. Since he arrived at Stanford in 1993, he has brought patients, prestige, and scores of surgeons to study at the Stanford Endoscopy Center, which he directs.
But along with his brother gynecologists, Drs. Farr and Ceana Nezhat, he has also brought trouble to this elite enclave of high-tech medicine.
Trailing him to Stanford are allegations of reckless and unethical medical conduct. Critics accuse the Nezhats of performing a bizarre and dangerous medical experiment on the rectums of vulnerable female patients and of falsifying data reported in medical journal articles.
In the past five years, 20 doctors and surgeons across the country have signed statements of serious concern about the Nezhats' surgeries and published research and have called for an investigation.
''In my experience in the fields of law and medicine, I can't imagine a group of men who have crossed the line in more ways in the field of bioethics than the Nezhats,'' said Andrea Scott, a Los Angeles attorney and bioethicist.
And if the allegations against the Nezhats are true, soon top Stanford administrators may face troubling questions about the extent to which they heeded repeated warnings about the Nezhats and investigated the charges against them.
While the American College of Gynecology's code of ethics requires members to report questionable medical practices, a top Stanford official threatened at least one doctor with a lawsuit if he continued to criticize the Nezhats.
''There are serious, serious problems going on at Stanford,'' said Dr. Tom Margolis, a former Stanford Medical School professor who has signed a sworn affidavit charging the Nezhats with misconduct. ''Certain people are covering this up because there is a hell of a lot of money going to Stanford because of the Nezhats.''
The Nezhat brothers have declined to be interviewed. Through their Atlanta attorneys, they deny any wrongdoing and question the motives of their accusers, citing professional rivalry and economic competition. Stanford officials say they have thoroughly investigated and rejected allegations of scientific fraud.
Camran Nezhat is embraced by a large cadre of supporters, including Stanford colleagues and patients, who admire him personally and are awestruck by his abilities in the operating room.
''People like (Nezhat) are a rarity,'' said Salinas gynecologist Dr. Rene Charles. ''I'd compare him to Michelangelo, in terms of his surgical skills.''
In a letter of support sent to The Chronicle, 39 Stanford nurses and other health-care staff members describe Nezhat as a worker of ''miracles'' who takes cases ''others have given up on.''
Yet doubts about the Nezhats date back well into the 1980s, when Camran emerged in Georgia as a pioneer in the nascent art of laparoscopic surgery.
And they have been rekindled by recent developments in an astounding malpractice case that has been languishing in Atlanta courts for six years.
That case could determine once and for all whether the Nezhats are the pioneering surgeons they claim to be or whether they catapulted their careers to Stanford on the basis of a dangerous and grotesque medical fraud.
BUILDING A PRACTICE, 1988
Camran Nezhat and his brothers grew up in prerevolutionary Iran, where each attended medical school. Camran emigrated to the United States in 1974 and completed his obstetrics and gynecology residency at the State University of New York at Buffalo.
In 1978, he received a two-year reproductive endocrinology fellowship at Medical College of Georgia in Augusta. Farr and Ceana followed their older brother to Augusta and eventually joined Camran's growing practice in Atlanta.
During the 1980s, while practicing at Atlanta's Northside Hospital, the Nezhats began to develop a reputation for their skills in laparoscopy, a type of surgery in which laser scalpels, miniature cameras and long-stemmed instruments are worked inside the body through dime-sized incisions.
They published scores of articles in medical journals, claiming a remarkable series of ''surgical firsts.'' They also developed a number of ingenious instruments for the laparoscopic operating room. A company they co-founded, American Hydro-Surgical Instruments Inc., eventually sold for $40 million.
Their specialty was treating endometriosis, a painful ailment afflicting an estimated 5 million American women. It is caused when cells that make up the lining of the uterus migrate and bind to other parts of the abdominal cavity, swelling with the monthly menstrual cycle, sometimes causing debilitating pain. The condition is often linked to infertility.
Northside Hospital began promoting the Nezhats, hiring a public relations firm to spread the word about the doctors and their accomplishments. Camran was featured in Newsweek and the Chicago Tribune, and on MSNBC, CNN, ABC's ''20/20'' and elsewhere.
The brothers garnered a reputation as some of the world's foremost innovators of laparoscopic surgery, attracting cash-paying patients from around the globe.
THE MULLEN CASE, 1991
Suffering from endometriosis, 28-year-old Stacey Mullen flew from Southern California to Atlanta's Northside Hospital in 1988 to be operated on by Camran Nezhat. The surgery was quick, the pain was gone, and Mullen was elated as she walked out of the hospital the next day.
''I was ready to name my firstborn after Camran Nezhat,'' she said.
But, as often happens, the endometriosis and the pain returned. And in December 1991, Mullen flew back to Atlanta for what she thought would be another ''quick little surgery.''
The surgery, however, was neither little nor quick.
Camran and his brother Farr, with colorectal surgeon Dr. Earl Pennington assisting, spent hours using laparoscopic techniques to cut Mullen's colon and rectum free of nerves, blood vessels and connecting tissue. Her ''mobilized'' rectum was pulled inside out through her anus, and suspected endometrial tissue was removed. Her patched-up rectum was then pushed back inside.
Then the complications began.
Hours after surgery, part of her colon dropped out of her body as she sat on the toilet. For months, she suffered from extreme constipation. Sometimes she burped up her own feces.
Mullen never regained normal use of her bowel. Eventually, she received a colostomy and must insert a tube into an opening in her side to go the bathroom.
In December 1993, after nearly two years of continuing pain, she filed a malpractice suit against the Nezhats. ''Those bastards ruined my life,'' she said.
THREE ARTICLES, 1993
Shortly after taking Mullen's case, attorney James Neal discovered two medical journal articles that the Nezhats and Pennington had published after Mullen's operation.
The first appeared in Fertility & Sterility in May 1992, describing a single case using the new pull-through procedure for treating rectal endometriosis. ''As with all new procedures,'' the article said, ''there are no data to establish its safety.''
The second was published in the September 1992 issue of Surgical Laparoscopy & Endoscopy. It detailed a series of 16 rectal surgeries, similar to Mullen's, performed in late 1991 and early 1992 - the period during which her surgery took place.
Yet Mullen's case - and her complications - were not mentioned.
The article listed only a single complication: The doctors had to perform traditional open abdominal surgery in order to complete the suturing of one patient's bowel.
''This procedure has been performed safely in this initial series,'' the Nezhats wrote, and they claimed fewer problems than would be expected with regular open abdominal surgery.
The Nezhats aggressively publicized the ''success'' of the new procedure. It was touted by Ethicon Inc., the Johnson & Johnson subsidiary that made the instruments the Nezhats had used. ''For the estimated 185,000 women who suffer from endometriosis of the rectum, this new advance provides them with relief from the digestive symptoms,'' the company said.
At a 1991 American Fertility Society meeting in Orlando, and a 1992 convention of the American College of Obstetricians and Gynecologists in Las Vegas, Ethicon promoted their instruments and the Nezhats, even including a video of the surgery.
But skepticism about the Nezhats and their procedure was beginning to grow. The lack of complications did not make sense for such radical bowel surgery, doctors said. Some surgeons who viewed the promotional video were puzzled: They could not see evidence of endometriosis.
Stories began circulating in the surgical community around Atlanta's Northside Hospital. The medical journal articles said the average operating time for the surgeries was three hours, but during the time of the study, the Nezhat operating room had been burning lights deep into the Georgia night.
Then Neal discovered a third journal publication, written by one of Nezhat's Atlanta colleagues and published more than a year after Mullen's operation.
The article in Surgical Endoscopy described a ''pilot'' study testing the same procedure on pigs in order to assess its safety on humans.
''Some damage to the sphincter might occur,'' the authors wrote, but the long-term effects were unknown: The pigs were ''sacrificed'' before they awoke from anesthesia.
Neal and Mullen were stunned: Not only had the Nezhats omitted Mullen's case from their series - and in doing so did not report her complications - they apparently had tried out the new procedure on her and other women before it was tested on pigs.
Nezhat attorney David Walbert said the pig study ''had nothing whatever to do with the safety and efficacy'' of the human surgery described in the medical journals. The purpose of the pig experiment, he said, was to determine whether the procedure was suitable for treating cancer.
'BARBARIC,' 1993
When Neal began contacting medical experts about Mullen's surgery, many sent him letters and affidavits calling the operation radical and experimental; they characterized it as ''bizarre'' and ''barbaric.'' It resembled a cancer surgery that had been discredited years before, after complication rates as high as 50 percent were reported.
The surgery had not been vetted before a Northside Hospital Institutional Review Board, the usual requirement for an experimental procedure.
''Normally you go before an IRB, come up with scientific background, present a plan, torturous documentation, nine pages of informed consent, and you cannot charge for it,'' said Ohio general surgeon Dr. Francis Barnes.
Mullen and her insurance company, however, were billed $9,900 for the rectal surgery. She eventually ran up more than $1 million in additional medical expenses as a result of the operation, according to Neal.
Neal also learned that Mullen - and possibly four other women whose cases were included in the Nezhats' articles - had signed an unusual document, recently created by the Georgia legislature. It was called a ''waiver of informed consent,'' and it set aside a patient's right to detailed information about a surgery.
''This is incomprehensibly unethical,'' said Arthur Caplan, director of the University of Pennsylvania Center for Bioethics and one of the nation's foremost medical ethicists. ''You can no more sign away your right to informed consent than you can voluntarily sell yourself to slavery.''
''I never knew I was signing such a document,'' Mullen said. ''I thought it was a regular consent form.''
Yet the most disturbing discovery was made in Mullen's own medical records. In his operative notes, Camran Nezhat wrote: ''There was evidence of severe endometriosis of the rectum.''
But Mullen's pathology lab report disclosed that there had been no endometriosis on the wall of her rectum at all - just a few cells in the adjoining fat. The surgery had not been necessary in the first place.
16 MEDICAL RECORDS
Neal went to court and demanded to see the medical records of the 16 other patients the Nezhats had operated on in Georgia, convinced they would show complications, more waivers of informed consent, and surgical data different from what was reported in the Nezhat articles.
But the Nezhat legal team refused to turn them over, citing privacy concerns of other patients - at least 10 of whom signed affidavits opposing any release.
Mullen was given the waiver form by mistake, they explained, and she was told about the procedure's risks. Medical experts for the Nezhats also insist that the rectal surgery was not experimental, so no Institutional Review Board process was required.
''In my opinion, the surgery performed on Mary (Stacey) Mullen was a necessary procedure and would not require any special consent form for experimental surgery,'' said Dr. Robert R. Franklin, a clinical professor in the department of obstetrics and gynecology at Houston's Baylor College of Medicine.
The Nezhat lawyers also argue that Mullen's rectal surgery did not cause her bowel problems. ''She reported constipation before the procedure,'' said Walbert.
THE FIRST WARNING, 1993
In the early 1990s, Stanford Medical School's department of obstetrics and gynecology was in trouble. Despite the school's lofty reputation, the department was not fully accredited.
The Chicago-based Accreditation Council for Graduate Medical Education demanded more ''surgical volume'' before it would upgrade the program's ''provisional'' status.
Yet when Dr. Nick Spirtos heard that Stanford was recruiting the Nezhats, he could not believe it.
Spirtos is a Palo Alto gynecological oncologist with an august reputation of his own. Like the Nezhats, he is a clinical professor, which means he serves on the school's voluntary teaching faculty with surgical privileges at the medical center. He also holds the elected post of deputy chief of the obstetrics and gynecology department.
During the past nine years, he has become a leading critic of the Nezhats and their Stanford defenders.
''I think everything they've written is fraudulent,'' said Spirtos, whose office is just one floor below the Nezhats' in an upscale medical office building near Stanford. ''I don't think they should be allowed to practice medicine.''
Spirtos had traveled with colleagues to a gynecology convention in Florida to see the 1991 presentation by Camran and Farr Nezhat sponsored by Ethicon. The program included videos of two new Nezhat operations, one of them showing the rectal procedure that would be performed two months later on Mullen.
''We couldn't believe what we saw,'' Spirtos said, noting that there was no evidence of endometriosis. ''The surgeries didn't make any sense.''
But before they could quiz the Nezhats about their presentation, Spirtos recalled, the Nezhats left the podium, refusing to answer questions.
Two years later, after studying their journal articles, he warned university administrators not to bring them to Stanford. Spirtos argued that the Nezhats' published data were simply too good to be true.
But Spirtos said his advice was ignored.
''It was a perfect marriage,'' he said. ''The Nezhats had all the dough in the world but no title. And Stanford needed desperately to have surgical volume to legitimize their (obstetrics and gynecology) department.''
NEW TROUBLE, 1993
Within two years of the Nezhats' arrival in Palo Alto, Camran became director of the new Stanford Endoscopy Center for Training and Technology. And Ethicon, which had retained Nezhat as a surgical investigator, agreed to provide a $125,000 annual grant to the center.
Quickly, the Nezhats began pairing up with surgeons outside their immediate discipline - including specialists in cancer, heart and brain surgery - with the goal of expanding the use of minimally invasive surgical techniques.
The practice troubled Spirtos, and when he learned that Camran Nezhat intended to operate on a patient of one of Spirtos' medical partners, he wrote in protest to Dr. Mary Lake Polan, the chief of the obstetrics and gynecology department.
The patient was a 74-year-old woman who had undergone extensive surgery for the removal of pelvic cancer, and Spirtos told Polan that the patient's cancer had spread so extensively that laparoscopic surgery would be useless.
''Certainly, (Nezhat) has no experience in this area (treating cancer), and it seems to me serious patient care issues are being placed on the back burner in your headlong rush to promote the Nezhats,'' he said in a 1993 letter to Polan.
Despite Spirtos' protests, Nezhat and Stanford cancer surgeon Dr. Nelson Teng went ahead with the operation.
The patient was on the operating table for seven hours and was hospitalized for seven days afterward. Her bladder and bowel were punctured during the operation, Spirtos said, and the doctors could not remove all the cancer. In his report to the university's ''quality assurance'' review committee, Spirtos charged that Nezhat, credentialed as a gynecologist, was performing cancer surgeries, a specialty that requires years of extra formal training. He also laid out four other Nezhat cancer cases for the quality assurance review committee.
''No other hospital would allow a gynecologist to perform (cancer) surgeries,'' said Spirtos.
But his hope for a quick review of the five cases soon faded. ''Stanford sat on those cases for years,'' he said.
NEZHAT'S AFFIDAVIT, 1994
Meanwhile, Mullen and her attorney continued to press for the release of the files on the 16 other women who had undergone the rectal procedure. And the Nezhats continued to refuse.
In a sworn 1994 affidavit, Camran Nezhat declared it would disrupt his practice for months if he were ordered to produce records demanded by Mullen's legal team.
He described a filing system with 20,000 patients, each listed only alphabetically, with no index, no computer database and no cross-referencing by type of treatment, surgery performed, or journal publication.
''I would . . . have to manually review every single patient record . . . to determine whether the record referenced a patient whose procedure was the subject of a journal article,'' he testified.
The affidavit shocked Nezhat's critics, who say it has cast a pall on the validity of the Nezhats' research ever since.
''I've been doing this kind of research for 25 years. There is a substantial problem if you cannot link patient records to publications,'' said Dr. David Grimes, former chief of obstetrics and gynecology at San Francisco General Hospital, who briefly served as a paid expert to Mullen's legal team.
How, asks Grimes, can the Nezhats publish extensive studies based on old charts and old data involving hundreds of patients over many years if those patients' files are not indexed or cross-referenced?
Grimes was not the first doctor to question the Nezhats' research. Long before they publicized their controversial bowel surgery, competitors and collaborators alike were skeptical of the brothers' claims of surgical firsts and problem-free procedures. In 1987, Dr. Harry Reich, a world-renowned laparoscopic surgeon at New York's Columbia-Presbyterian Medical Center, agreed to collaborate with Camran Nezhat on a surgical study of 105 tubal pregnancies.
But Reich was bothered by Nezhat's repeated failure to share his data on 40 patients to be included in their article in the Journal of Reproductive Medicine.
''So we had to delete the data from the paper,'' Reich recalled.
The Nezhats' lawyers say Reich never requested any data that were not provided.
In 1990, a Nezhat report in the journal Obstetrics and Gynecology also raised eyebrows. The Nezhats stated they had performed 4,000 laparoscopic surgeries without injuring a ureter, the tube connecting the kidney and bladder.
Their claim drew a sarcastic response from three Yale University doctors: ''The authors are to be congratulated. . . . Either these surgeons had other complications, perhaps as serious, or they possess an unbelievably high level of skill and judgment.''
Other articles in which the Nezhats claim to have reviewed thousands of old cases include:
-- A 1995 textbook article describing 214 complications among 6,949 cases in Atlanta and Stanford from 1982 to 1993.
-- A 1996 medical journal report of severe urinary tract endometriosis in 28 women among 2,226 treated for endometriosis from 1989 to 1994.
-- A 1997 study examining 5,300 surgeries dating back to 1988, counting up 11 hernias caused by insertion of the laparoscope.
Atlanta attorney Walbert scoffs at accusations of medical fraud. ''Many, many surgeons'' have conducted research with the Nezhats, he said. ''Those who have any knowledge have never claimed there was anything 'bogus' about any of the reports.''
Dr. Sally Tazuke, a Stanford reproductive endocrinologist who has worked with Camran Nezhat frequently, said his reported complications are low because he is exceptionally good at what he does - even while taking on the riskiest cases. ''If I were a patient, I would sign up with him. I'd send any family member,'' she said.
Skeptics say the stakes are high. Dr. Thomas Lyons, an Atlanta gynecological surgeon who believes the Nezhats have published journal articles with phony data, said medical fraud can lead unsuspecting doctors to hurt their patients.
''This is as dangerous a situation as you can run into in medicine, because people may be making medical decisions based on something that doesn't exist,'' he said.
If someone ever questioned the veracity of his own data, Lyons said, ''The first thing I would do is throw that data right in their face. . . . The best defense in the world is the truth.''
NEAL'S LETTER, 1995
In January 1995, Mullen's attorney, James Neal, wrote to Stanford, alerting the university to the allegations his legal team was making against the Nezhats. As a former hospital counsel himself, he said he thought they would appreciate a copy of the Mullen lawsuit.
''I feel that your institution should have the opportunity to evaluate these matters . . . given your understandable and overriding concern for the patients within your institution,'' Neal wrote.
But Stanford took no action.
Instead, Margaret Eaton, a university lawyer, forwarded the letter to Nezhat's attorney in Atlanta, with a note saying that ''we do not intend to respond to this letter, nor are further communications from Mr. Neal welcome.''
In June 1995 the Accreditation Council for Graduate Medical Education approved full accreditation to Stanford.
ALLEGATIONS, 1996
A year later, Neal sent Stanford a thick package of documents, laying out in more detail the charges against the Nezhats and asking Stanford to investigate.
Dr. Richard Popp, Stanford's senior associate dean for academic affairs, said Neal provided a ''massive amount'' of what he called ''disorganized'' information.
Popp finally opened an inquiry into the charge of scientific misconduct. But university officials contend that by that time, some of the allegations, including Neal's claim of medical journal fraud, had been thrown out by the Georgia courts.
Neal, who freely admits that he has become obsessed with exposing the Nezhats, was running up a list of legal setbacks. In his dogged pursuit of the Nezhats, he was building a reputation as a crank.
He was disqualified from the malpractice case by a Georgia judge in 1995 for ''unethical behavior'' and could no longer represent Mullen. After a federal judge last year tossed out his attempt, on behalf of another client charging malpractice, to use racketeering charges against the Nezhats, Neal was charged with contempt of court. The judge also assessed $384,000 in ''sanctions'' against the plaintiff and her remaining attorneys. The sanctions are on appeal.
Neal denies the unethical conduct allegation, and the contempt of court charge was recently dropped. The only thing he is guilty of, he says, is aggressively representing his clients against institutions willing to look the other way.
''These guys are bad doctors, some have even said evil, and they have to be stopped,'' he said.
WITNESS, 1996
Shortly after Dr. Tom Margolis joined Stanford as an assistant professor and chief of pelvic surgery, Farr Nezhat invited the newcomer to watch him perform a complex laparoscopic procedure.
During the operation, Nezhat cut the patient's ureter. Margolis, who had also served as director of urogynecologic/pelvic surgery at Northwestern University Medical School, assumed it was an accident, a known but unwelcome complication of the difficult surgical technique. He stepped in to assist Nezhat in repairing it.
But a short time later Margolis learned that, in a post-operative review session and the operative report, Nezhat described the cut as deliberate. He said he sliced the ureter to remove endometriosis that could have blocked urine flow.
Margolis was outraged. He said that he saw no endometriosis on the ureter and that the pathology report proved it.
''It was clear that Dr. Nezhat was performing an unnecessary procedure,'' he said in a sworn affidavit.
THE POLAN MEETING, 1996
More than two years passed before Stanford's quality assurance committee took up the review of the five cancer cases in which Spirtos had alleged improper surgeries by Camran Nezhat.
Just before the review committee was finally set to meet, Dr. Mary Lake Polan, chairman of obstetrics and gynecology, dropped by Margolis' office. He was one of the physicians reviewing the cases.
''We need to make sure that Nezhat is cleared on all these (cancer) cases,'' she told him, according to his affidavit.
Ultimately Margolis - and the other members of the quality assurance committee - voted in favor of Nezhat on all charges.
Polan said Margolis' allegations are false.
''I adamantly deny the statements attributed to me and deny there has been any pressure to exonerate any physician during the quality of care committee process," she declared in a written response to The Chronicle.
Margolis' decision to vote to exonerate Nezhat would haunt him for more than a year, until finally he had to act.
THE SHUER LETTER, 1998
In April 1998, Margolis met with Dr. Lawrence Shuer, chief of staff of the medical center. He told Shuer about the cut ureter incident and the pressure Polan had allegedly exerted on him.
''He (Shuer) acutely and abruptly ended our conversation, and I was excused from his office,'' Margolis said.
More than a year later, when Shuer learned Margolis was still criticizing the Nezhats and Stanford, he sent a written warning:
''Rest assured that Stanford Hospital and Clinics intends to pursue its full legal remedies if these defamatory and libelous statement do not cease,'' Shuer wrote.
Furious, Margolis, who had left Stanford to practice with Spirtos at the Women's Cancer Center in Palo Alto and Los Gatos, wrote back, saying that Shuer's job as chief of staff was ''patient protection not doctor protection.''
''The data which (the Nezhats) have published, including the rectal eversion procedure, is fraudulent, yet their publications are being accepted as standards in the surgical community. Stanford, by not auditing this clinical data, has ignored the concerns of scores of surgeons,'' Margolis wrote.
STANFORD'S DUTY, 2000
Defenders of the Nezhats at Stanford dismiss both Spirtos and Margolis as jealous competitors. But other medical experts say Stanford should have demanded a review of the 16 cases and has shirked its responsibility to verify the Nezhats' research claims.
''Stanford has a duty to review this,'' said Dr. Warren Grundfest, chairman of Biomedical Engineering at UCLA and an expert in new medical technologies. ''Serious allegations have been made by credible people, but Stanford has played like an ostrich with its head in the sand.''
But Stanford officials contend they are not obligated to review the 16 patient records because the rectal surgeries were performed in Georgia before the Nezhats came to the West Coast. Shuer said the procedure in question has never been performed at Stanford.
It was appropriate for the Nezhats to leave Mullen's case out of the medical journal, according to Stanford, because she was ultimately found not to have rectal endometriosis like the other patients.
Stanford reviewers have never asked the Nezhats or Northside Hospital for the records to verify the accuracy of the other 16 cases. ''We have no right to the records and do not want to violate patient privacy,'' said Stanford's lawyer Debra Zumwalt.
The university also never interviewed Mullen or the 20 doctors who have expressed concern over the Nezhats' research.
According to Stanford, the appropriate institutions to investigate the Nezhats are Northside Hospital, the Georgia Medical Board and Mercer University, where the Nezhats were clinical professors at the time of the surgeries. ''Stanford will carefully review the conclusions of those investigations,'' said Popp.
But a spokesman for Mercer, a Macon, Ga., medical school founded in 1986, said the school has no investigation pending.
The Georgia Medical Board's investigation of the Nezhats is continuing. The board will not comment on its status.
Stanford attorney Zumwalt said Margolis' complaint to Shuer regarding the cut ureter incident was never put in writing. Shuer said he asked Margolis for more information, and none was provided, but the case has now been identified and is being investigated by the quality assurance committee.
The university said the Nezhats have been cleared of allegations that they operated outside their specialty. Officials would not comment, however, on any details of the five quality assurance cases because they are confidential.
''One thing I can point out,'' said Zumwalt, ''is that doctors and patients and their families can reasonably disagree as to how aggressive to be in treating terminal diseases.''
GEORGIA COURTROOM, 2000
Mullen has refused to engage in monetary settlement talks with the Nezhats and promises to continue her suit until the records of the 16 other women are made public.
''My life has been changed in a very horrible and profound way by the experiment (that) Camran Nezhat has conducted upon me without my knowledge,'' Mullen said in an affidavit. ''I despair that other women will be injured by well-meaning surgeons who believe Camran Nezhat's article that there were no complications from this new surgery.''
In November, after a battle spanning six years - and six judges - Superior Court Judge Melvin Westmoreland in Atlanta ordered a confidential release of the records to Mullen's lawyers, and in January, the Nezhats and Northside Hospital turned them over.
While the records remain sealed, medical experts hired by Mullen's legal team to review the documents have written Judge Westmoreland expressing their concern about what the records contain, and urging that they be unsealed, in the public interest. ..
William Carlsen can be reached at wcarlsen@sfgate.com. Sabin Russell can be reached at sabin@sfgate.com.
Supporters say Camran Nezhat is a miracle worker -- critics call his operations bizarre and barbaric
With a white surgical mask dangling rakishly below his chin, Dr. Camran Nezhat looks every bit the part in his promotional video: medical pioneer, gifted surgeon, millionaire inventor of operating room tools. The Stanford clinical professor, recruited from his lucrative Atlanta practice, is a rainmaker for the university's medical center and obstetrics and gynecology department. Since he arrived at Stanford in 1993, he has brought patients, prestige, and scores of surgeons to study at the Stanford Endoscopy Center, which he directs.
But along with his brother gynecologists, Drs. Farr and Ceana Nezhat, he has also brought trouble to this elite enclave of high-tech medicine.
Trailing him to Stanford are allegations of reckless and unethical medical conduct. Critics accuse the Nezhats of performing a bizarre and dangerous medical experiment on the rectums of vulnerable female patients and of falsifying data reported in medical journal articles.
In the past five years, 20 doctors and surgeons across the country have signed statements of serious concern about the Nezhats' surgeries and published research and have called for an investigation.
''In my experience in the fields of law and medicine, I can't imagine a group of men who have crossed the line in more ways in the field of bioethics than the Nezhats,'' said Andrea Scott, a Los Angeles attorney and bioethicist.
And if the allegations against the Nezhats are true, soon top Stanford administrators may face troubling questions about the extent to which they heeded repeated warnings about the Nezhats and investigated the charges against them.
While the American College of Gynecology's code of ethics requires members to report questionable medical practices, a top Stanford official threatened at least one doctor with a lawsuit if he continued to criticize the Nezhats.
''There are serious, serious problems going on at Stanford,'' said Dr. Tom Margolis, a former Stanford Medical School professor who has signed a sworn affidavit charging the Nezhats with misconduct. ''Certain people are covering this up because there is a hell of a lot of money going to Stanford because of the Nezhats.''
The Nezhat brothers have declined to be interviewed. Through their Atlanta attorneys, they deny any wrongdoing and question the motives of their accusers, citing professional rivalry and economic competition. Stanford officials say they have thoroughly investigated and rejected allegations of scientific fraud.
Camran Nezhat is embraced by a large cadre of supporters, including Stanford colleagues and patients, who admire him personally and are awestruck by his abilities in the operating room.
''People like (Nezhat) are a rarity,'' said Salinas gynecologist Dr. Rene Charles. ''I'd compare him to Michelangelo, in terms of his surgical skills.''
In a letter of support sent to The Chronicle, 39 Stanford nurses and other health-care staff members describe Nezhat as a worker of ''miracles'' who takes cases ''others have given up on.''
Yet doubts about the Nezhats date back well into the 1980s, when Camran emerged in Georgia as a pioneer in the nascent art of laparoscopic surgery.
And they have been rekindled by recent developments in an astounding malpractice case that has been languishing in Atlanta courts for six years.
That case could determine once and for all whether the Nezhats are the pioneering surgeons they claim to be or whether they catapulted their careers to Stanford on the basis of a dangerous and grotesque medical fraud.
BUILDING A PRACTICE, 1988
Camran Nezhat and his brothers grew up in prerevolutionary Iran, where each attended medical school. Camran emigrated to the United States in 1974 and completed his obstetrics and gynecology residency at the State University of New York at Buffalo.
In 1978, he received a two-year reproductive endocrinology fellowship at Medical College of Georgia in Augusta. Farr and Ceana followed their older brother to Augusta and eventually joined Camran's growing practice in Atlanta.
During the 1980s, while practicing at Atlanta's Northside Hospital, the Nezhats began to develop a reputation for their skills in laparoscopy, a type of surgery in which laser scalpels, miniature cameras and long-stemmed instruments are worked inside the body through dime-sized incisions.
They published scores of articles in medical journals, claiming a remarkable series of ''surgical firsts.'' They also developed a number of ingenious instruments for the laparoscopic operating room. A company they co-founded, American Hydro-Surgical Instruments Inc., eventually sold for $40 million.
Their specialty was treating endometriosis, a painful ailment afflicting an estimated 5 million American women. It is caused when cells that make up the lining of the uterus migrate and bind to other parts of the abdominal cavity, swelling with the monthly menstrual cycle, sometimes causing debilitating pain. The condition is often linked to infertility.
Northside Hospital began promoting the Nezhats, hiring a public relations firm to spread the word about the doctors and their accomplishments. Camran was featured in Newsweek and the Chicago Tribune, and on MSNBC, CNN, ABC's ''20/20'' and elsewhere.
The brothers garnered a reputation as some of the world's foremost innovators of laparoscopic surgery, attracting cash-paying patients from around the globe.
THE MULLEN CASE, 1991
Suffering from endometriosis, 28-year-old Stacey Mullen flew from Southern California to Atlanta's Northside Hospital in 1988 to be operated on by Camran Nezhat. The surgery was quick, the pain was gone, and Mullen was elated as she walked out of the hospital the next day.
''I was ready to name my firstborn after Camran Nezhat,'' she said.
But, as often happens, the endometriosis and the pain returned. And in December 1991, Mullen flew back to Atlanta for what she thought would be another ''quick little surgery.''
The surgery, however, was neither little nor quick.
Camran and his brother Farr, with colorectal surgeon Dr. Earl Pennington assisting, spent hours using laparoscopic techniques to cut Mullen's colon and rectum free of nerves, blood vessels and connecting tissue. Her ''mobilized'' rectum was pulled inside out through her anus, and suspected endometrial tissue was removed. Her patched-up rectum was then pushed back inside.
Then the complications began.
Hours after surgery, part of her colon dropped out of her body as she sat on the toilet. For months, she suffered from extreme constipation. Sometimes she burped up her own feces.
Mullen never regained normal use of her bowel. Eventually, she received a colostomy and must insert a tube into an opening in her side to go the bathroom.
In December 1993, after nearly two years of continuing pain, she filed a malpractice suit against the Nezhats. ''Those bastards ruined my life,'' she said.
THREE ARTICLES, 1993
Shortly after taking Mullen's case, attorney James Neal discovered two medical journal articles that the Nezhats and Pennington had published after Mullen's operation.
The first appeared in Fertility & Sterility in May 1992, describing a single case using the new pull-through procedure for treating rectal endometriosis. ''As with all new procedures,'' the article said, ''there are no data to establish its safety.''
The second was published in the September 1992 issue of Surgical Laparoscopy & Endoscopy. It detailed a series of 16 rectal surgeries, similar to Mullen's, performed in late 1991 and early 1992 - the period during which her surgery took place.
Yet Mullen's case - and her complications - were not mentioned.
The article listed only a single complication: The doctors had to perform traditional open abdominal surgery in order to complete the suturing of one patient's bowel.
''This procedure has been performed safely in this initial series,'' the Nezhats wrote, and they claimed fewer problems than would be expected with regular open abdominal surgery.
The Nezhats aggressively publicized the ''success'' of the new procedure. It was touted by Ethicon Inc., the Johnson & Johnson subsidiary that made the instruments the Nezhats had used. ''For the estimated 185,000 women who suffer from endometriosis of the rectum, this new advance provides them with relief from the digestive symptoms,'' the company said.
At a 1991 American Fertility Society meeting in Orlando, and a 1992 convention of the American College of Obstetricians and Gynecologists in Las Vegas, Ethicon promoted their instruments and the Nezhats, even including a video of the surgery.
But skepticism about the Nezhats and their procedure was beginning to grow. The lack of complications did not make sense for such radical bowel surgery, doctors said. Some surgeons who viewed the promotional video were puzzled: They could not see evidence of endometriosis.
Stories began circulating in the surgical community around Atlanta's Northside Hospital. The medical journal articles said the average operating time for the surgeries was three hours, but during the time of the study, the Nezhat operating room had been burning lights deep into the Georgia night.
Then Neal discovered a third journal publication, written by one of Nezhat's Atlanta colleagues and published more than a year after Mullen's operation.
The article in Surgical Endoscopy described a ''pilot'' study testing the same procedure on pigs in order to assess its safety on humans.
''Some damage to the sphincter might occur,'' the authors wrote, but the long-term effects were unknown: The pigs were ''sacrificed'' before they awoke from anesthesia.
Neal and Mullen were stunned: Not only had the Nezhats omitted Mullen's case from their series - and in doing so did not report her complications - they apparently had tried out the new procedure on her and other women before it was tested on pigs.
Nezhat attorney David Walbert said the pig study ''had nothing whatever to do with the safety and efficacy'' of the human surgery described in the medical journals. The purpose of the pig experiment, he said, was to determine whether the procedure was suitable for treating cancer.
'BARBARIC,' 1993
When Neal began contacting medical experts about Mullen's surgery, many sent him letters and affidavits calling the operation radical and experimental; they characterized it as ''bizarre'' and ''barbaric.'' It resembled a cancer surgery that had been discredited years before, after complication rates as high as 50 percent were reported.
The surgery had not been vetted before a Northside Hospital Institutional Review Board, the usual requirement for an experimental procedure.
''Normally you go before an IRB, come up with scientific background, present a plan, torturous documentation, nine pages of informed consent, and you cannot charge for it,'' said Ohio general surgeon Dr. Francis Barnes.
Mullen and her insurance company, however, were billed $9,900 for the rectal surgery. She eventually ran up more than $1 million in additional medical expenses as a result of the operation, according to Neal.
Neal also learned that Mullen - and possibly four other women whose cases were included in the Nezhats' articles - had signed an unusual document, recently created by the Georgia legislature. It was called a ''waiver of informed consent,'' and it set aside a patient's right to detailed information about a surgery.
''This is incomprehensibly unethical,'' said Arthur Caplan, director of the University of Pennsylvania Center for Bioethics and one of the nation's foremost medical ethicists. ''You can no more sign away your right to informed consent than you can voluntarily sell yourself to slavery.''
''I never knew I was signing such a document,'' Mullen said. ''I thought it was a regular consent form.''
Yet the most disturbing discovery was made in Mullen's own medical records. In his operative notes, Camran Nezhat wrote: ''There was evidence of severe endometriosis of the rectum.''
But Mullen's pathology lab report disclosed that there had been no endometriosis on the wall of her rectum at all - just a few cells in the adjoining fat. The surgery had not been necessary in the first place.
16 MEDICAL RECORDS
Neal went to court and demanded to see the medical records of the 16 other patients the Nezhats had operated on in Georgia, convinced they would show complications, more waivers of informed consent, and surgical data different from what was reported in the Nezhat articles.
But the Nezhat legal team refused to turn them over, citing privacy concerns of other patients - at least 10 of whom signed affidavits opposing any release.
Mullen was given the waiver form by mistake, they explained, and she was told about the procedure's risks. Medical experts for the Nezhats also insist that the rectal surgery was not experimental, so no Institutional Review Board process was required.
''In my opinion, the surgery performed on Mary (Stacey) Mullen was a necessary procedure and would not require any special consent form for experimental surgery,'' said Dr. Robert R. Franklin, a clinical professor in the department of obstetrics and gynecology at Houston's Baylor College of Medicine.
The Nezhat lawyers also argue that Mullen's rectal surgery did not cause her bowel problems. ''She reported constipation before the procedure,'' said Walbert.
THE FIRST WARNING, 1993
In the early 1990s, Stanford Medical School's department of obstetrics and gynecology was in trouble. Despite the school's lofty reputation, the department was not fully accredited.
The Chicago-based Accreditation Council for Graduate Medical Education demanded more ''surgical volume'' before it would upgrade the program's ''provisional'' status.
Yet when Dr. Nick Spirtos heard that Stanford was recruiting the Nezhats, he could not believe it.
Spirtos is a Palo Alto gynecological oncologist with an august reputation of his own. Like the Nezhats, he is a clinical professor, which means he serves on the school's voluntary teaching faculty with surgical privileges at the medical center. He also holds the elected post of deputy chief of the obstetrics and gynecology department.
During the past nine years, he has become a leading critic of the Nezhats and their Stanford defenders.
''I think everything they've written is fraudulent,'' said Spirtos, whose office is just one floor below the Nezhats' in an upscale medical office building near Stanford. ''I don't think they should be allowed to practice medicine.''
Spirtos had traveled with colleagues to a gynecology convention in Florida to see the 1991 presentation by Camran and Farr Nezhat sponsored by Ethicon. The program included videos of two new Nezhat operations, one of them showing the rectal procedure that would be performed two months later on Mullen.
''We couldn't believe what we saw,'' Spirtos said, noting that there was no evidence of endometriosis. ''The surgeries didn't make any sense.''
But before they could quiz the Nezhats about their presentation, Spirtos recalled, the Nezhats left the podium, refusing to answer questions.
Two years later, after studying their journal articles, he warned university administrators not to bring them to Stanford. Spirtos argued that the Nezhats' published data were simply too good to be true.
But Spirtos said his advice was ignored.
''It was a perfect marriage,'' he said. ''The Nezhats had all the dough in the world but no title. And Stanford needed desperately to have surgical volume to legitimize their (obstetrics and gynecology) department.''
NEW TROUBLE, 1993
Within two years of the Nezhats' arrival in Palo Alto, Camran became director of the new Stanford Endoscopy Center for Training and Technology. And Ethicon, which had retained Nezhat as a surgical investigator, agreed to provide a $125,000 annual grant to the center.
Quickly, the Nezhats began pairing up with surgeons outside their immediate discipline - including specialists in cancer, heart and brain surgery - with the goal of expanding the use of minimally invasive surgical techniques.
The practice troubled Spirtos, and when he learned that Camran Nezhat intended to operate on a patient of one of Spirtos' medical partners, he wrote in protest to Dr. Mary Lake Polan, the chief of the obstetrics and gynecology department.
The patient was a 74-year-old woman who had undergone extensive surgery for the removal of pelvic cancer, and Spirtos told Polan that the patient's cancer had spread so extensively that laparoscopic surgery would be useless.
''Certainly, (Nezhat) has no experience in this area (treating cancer), and it seems to me serious patient care issues are being placed on the back burner in your headlong rush to promote the Nezhats,'' he said in a 1993 letter to Polan.
Despite Spirtos' protests, Nezhat and Stanford cancer surgeon Dr. Nelson Teng went ahead with the operation.
The patient was on the operating table for seven hours and was hospitalized for seven days afterward. Her bladder and bowel were punctured during the operation, Spirtos said, and the doctors could not remove all the cancer. In his report to the university's ''quality assurance'' review committee, Spirtos charged that Nezhat, credentialed as a gynecologist, was performing cancer surgeries, a specialty that requires years of extra formal training. He also laid out four other Nezhat cancer cases for the quality assurance review committee.
''No other hospital would allow a gynecologist to perform (cancer) surgeries,'' said Spirtos.
But his hope for a quick review of the five cases soon faded. ''Stanford sat on those cases for years,'' he said.
NEZHAT'S AFFIDAVIT, 1994
Meanwhile, Mullen and her attorney continued to press for the release of the files on the 16 other women who had undergone the rectal procedure. And the Nezhats continued to refuse.
In a sworn 1994 affidavit, Camran Nezhat declared it would disrupt his practice for months if he were ordered to produce records demanded by Mullen's legal team.
He described a filing system with 20,000 patients, each listed only alphabetically, with no index, no computer database and no cross-referencing by type of treatment, surgery performed, or journal publication.
''I would . . . have to manually review every single patient record . . . to determine whether the record referenced a patient whose procedure was the subject of a journal article,'' he testified.
The affidavit shocked Nezhat's critics, who say it has cast a pall on the validity of the Nezhats' research ever since.
''I've been doing this kind of research for 25 years. There is a substantial problem if you cannot link patient records to publications,'' said Dr. David Grimes, former chief of obstetrics and gynecology at San Francisco General Hospital, who briefly served as a paid expert to Mullen's legal team.
How, asks Grimes, can the Nezhats publish extensive studies based on old charts and old data involving hundreds of patients over many years if those patients' files are not indexed or cross-referenced?
Grimes was not the first doctor to question the Nezhats' research. Long before they publicized their controversial bowel surgery, competitors and collaborators alike were skeptical of the brothers' claims of surgical firsts and problem-free procedures. In 1987, Dr. Harry Reich, a world-renowned laparoscopic surgeon at New York's Columbia-Presbyterian Medical Center, agreed to collaborate with Camran Nezhat on a surgical study of 105 tubal pregnancies.
But Reich was bothered by Nezhat's repeated failure to share his data on 40 patients to be included in their article in the Journal of Reproductive Medicine.
''So we had to delete the data from the paper,'' Reich recalled.
The Nezhats' lawyers say Reich never requested any data that were not provided.
In 1990, a Nezhat report in the journal Obstetrics and Gynecology also raised eyebrows. The Nezhats stated they had performed 4,000 laparoscopic surgeries without injuring a ureter, the tube connecting the kidney and bladder.
Their claim drew a sarcastic response from three Yale University doctors: ''The authors are to be congratulated. . . . Either these surgeons had other complications, perhaps as serious, or they possess an unbelievably high level of skill and judgment.''
Other articles in which the Nezhats claim to have reviewed thousands of old cases include:
-- A 1995 textbook article describing 214 complications among 6,949 cases in Atlanta and Stanford from 1982 to 1993.
-- A 1996 medical journal report of severe urinary tract endometriosis in 28 women among 2,226 treated for endometriosis from 1989 to 1994.
-- A 1997 study examining 5,300 surgeries dating back to 1988, counting up 11 hernias caused by insertion of the laparoscope.
Atlanta attorney Walbert scoffs at accusations of medical fraud. ''Many, many surgeons'' have conducted research with the Nezhats, he said. ''Those who have any knowledge have never claimed there was anything 'bogus' about any of the reports.''
Dr. Sally Tazuke, a Stanford reproductive endocrinologist who has worked with Camran Nezhat frequently, said his reported complications are low because he is exceptionally good at what he does - even while taking on the riskiest cases. ''If I were a patient, I would sign up with him. I'd send any family member,'' she said.
Skeptics say the stakes are high. Dr. Thomas Lyons, an Atlanta gynecological surgeon who believes the Nezhats have published journal articles with phony data, said medical fraud can lead unsuspecting doctors to hurt their patients.
''This is as dangerous a situation as you can run into in medicine, because people may be making medical decisions based on something that doesn't exist,'' he said.
If someone ever questioned the veracity of his own data, Lyons said, ''The first thing I would do is throw that data right in their face. . . . The best defense in the world is the truth.''
NEAL'S LETTER, 1995
In January 1995, Mullen's attorney, James Neal, wrote to Stanford, alerting the university to the allegations his legal team was making against the Nezhats. As a former hospital counsel himself, he said he thought they would appreciate a copy of the Mullen lawsuit.
''I feel that your institution should have the opportunity to evaluate these matters . . . given your understandable and overriding concern for the patients within your institution,'' Neal wrote.
But Stanford took no action.
Instead, Margaret Eaton, a university lawyer, forwarded the letter to Nezhat's attorney in Atlanta, with a note saying that ''we do not intend to respond to this letter, nor are further communications from Mr. Neal welcome.''
In June 1995 the Accreditation Council for Graduate Medical Education approved full accreditation to Stanford.
ALLEGATIONS, 1996
A year later, Neal sent Stanford a thick package of documents, laying out in more detail the charges against the Nezhats and asking Stanford to investigate.
Dr. Richard Popp, Stanford's senior associate dean for academic affairs, said Neal provided a ''massive amount'' of what he called ''disorganized'' information.
Popp finally opened an inquiry into the charge of scientific misconduct. But university officials contend that by that time, some of the allegations, including Neal's claim of medical journal fraud, had been thrown out by the Georgia courts.
Neal, who freely admits that he has become obsessed with exposing the Nezhats, was running up a list of legal setbacks. In his dogged pursuit of the Nezhats, he was building a reputation as a crank.
He was disqualified from the malpractice case by a Georgia judge in 1995 for ''unethical behavior'' and could no longer represent Mullen. After a federal judge last year tossed out his attempt, on behalf of another client charging malpractice, to use racketeering charges against the Nezhats, Neal was charged with contempt of court. The judge also assessed $384,000 in ''sanctions'' against the plaintiff and her remaining attorneys. The sanctions are on appeal.
Neal denies the unethical conduct allegation, and the contempt of court charge was recently dropped. The only thing he is guilty of, he says, is aggressively representing his clients against institutions willing to look the other way.
''These guys are bad doctors, some have even said evil, and they have to be stopped,'' he said.
WITNESS, 1996
Shortly after Dr. Tom Margolis joined Stanford as an assistant professor and chief of pelvic surgery, Farr Nezhat invited the newcomer to watch him perform a complex laparoscopic procedure.
During the operation, Nezhat cut the patient's ureter. Margolis, who had also served as director of urogynecologic/pelvic surgery at Northwestern University Medical School, assumed it was an accident, a known but unwelcome complication of the difficult surgical technique. He stepped in to assist Nezhat in repairing it.
But a short time later Margolis learned that, in a post-operative review session and the operative report, Nezhat described the cut as deliberate. He said he sliced the ureter to remove endometriosis that could have blocked urine flow.
Margolis was outraged. He said that he saw no endometriosis on the ureter and that the pathology report proved it.
''It was clear that Dr. Nezhat was performing an unnecessary procedure,'' he said in a sworn affidavit.
THE POLAN MEETING, 1996
More than two years passed before Stanford's quality assurance committee took up the review of the five cancer cases in which Spirtos had alleged improper surgeries by Camran Nezhat.
Just before the review committee was finally set to meet, Dr. Mary Lake Polan, chairman of obstetrics and gynecology, dropped by Margolis' office. He was one of the physicians reviewing the cases.
''We need to make sure that Nezhat is cleared on all these (cancer) cases,'' she told him, according to his affidavit.
Ultimately Margolis - and the other members of the quality assurance committee - voted in favor of Nezhat on all charges.
Polan said Margolis' allegations are false.
''I adamantly deny the statements attributed to me and deny there has been any pressure to exonerate any physician during the quality of care committee process," she declared in a written response to The Chronicle.
Margolis' decision to vote to exonerate Nezhat would haunt him for more than a year, until finally he had to act.
THE SHUER LETTER, 1998
In April 1998, Margolis met with Dr. Lawrence Shuer, chief of staff of the medical center. He told Shuer about the cut ureter incident and the pressure Polan had allegedly exerted on him.
''He (Shuer) acutely and abruptly ended our conversation, and I was excused from his office,'' Margolis said.
More than a year later, when Shuer learned Margolis was still criticizing the Nezhats and Stanford, he sent a written warning:
''Rest assured that Stanford Hospital and Clinics intends to pursue its full legal remedies if these defamatory and libelous statement do not cease,'' Shuer wrote.
Furious, Margolis, who had left Stanford to practice with Spirtos at the Women's Cancer Center in Palo Alto and Los Gatos, wrote back, saying that Shuer's job as chief of staff was ''patient protection not doctor protection.''
''The data which (the Nezhats) have published, including the rectal eversion procedure, is fraudulent, yet their publications are being accepted as standards in the surgical community. Stanford, by not auditing this clinical data, has ignored the concerns of scores of surgeons,'' Margolis wrote.
STANFORD'S DUTY, 2000
Defenders of the Nezhats at Stanford dismiss both Spirtos and Margolis as jealous competitors. But other medical experts say Stanford should have demanded a review of the 16 cases and has shirked its responsibility to verify the Nezhats' research claims.
''Stanford has a duty to review this,'' said Dr. Warren Grundfest, chairman of Biomedical Engineering at UCLA and an expert in new medical technologies. ''Serious allegations have been made by credible people, but Stanford has played like an ostrich with its head in the sand.''
But Stanford officials contend they are not obligated to review the 16 patient records because the rectal surgeries were performed in Georgia before the Nezhats came to the West Coast. Shuer said the procedure in question has never been performed at Stanford.
It was appropriate for the Nezhats to leave Mullen's case out of the medical journal, according to Stanford, because she was ultimately found not to have rectal endometriosis like the other patients.
Stanford reviewers have never asked the Nezhats or Northside Hospital for the records to verify the accuracy of the other 16 cases. ''We have no right to the records and do not want to violate patient privacy,'' said Stanford's lawyer Debra Zumwalt.
The university also never interviewed Mullen or the 20 doctors who have expressed concern over the Nezhats' research.
According to Stanford, the appropriate institutions to investigate the Nezhats are Northside Hospital, the Georgia Medical Board and Mercer University, where the Nezhats were clinical professors at the time of the surgeries. ''Stanford will carefully review the conclusions of those investigations,'' said Popp.
But a spokesman for Mercer, a Macon, Ga., medical school founded in 1986, said the school has no investigation pending.
The Georgia Medical Board's investigation of the Nezhats is continuing. The board will not comment on its status.
Stanford attorney Zumwalt said Margolis' complaint to Shuer regarding the cut ureter incident was never put in writing. Shuer said he asked Margolis for more information, and none was provided, but the case has now been identified and is being investigated by the quality assurance committee.
The university said the Nezhats have been cleared of allegations that they operated outside their specialty. Officials would not comment, however, on any details of the five quality assurance cases because they are confidential.
''One thing I can point out,'' said Zumwalt, ''is that doctors and patients and their families can reasonably disagree as to how aggressive to be in treating terminal diseases.''
GEORGIA COURTROOM, 2000
Mullen has refused to engage in monetary settlement talks with the Nezhats and promises to continue her suit until the records of the 16 other women are made public.
''My life has been changed in a very horrible and profound way by the experiment (that) Camran Nezhat has conducted upon me without my knowledge,'' Mullen said in an affidavit. ''I despair that other women will be injured by well-meaning surgeons who believe Camran Nezhat's article that there were no complications from this new surgery.''
In November, after a battle spanning six years - and six judges - Superior Court Judge Melvin Westmoreland in Atlanta ordered a confidential release of the records to Mullen's lawyers, and in January, the Nezhats and Northside Hospital turned them over.
While the records remain sealed, medical experts hired by Mullen's legal team to review the documents have written Judge Westmoreland expressing their concern about what the records contain, and urging that they be unsealed, in the public interest. ..
William Carlsen can be reached at wcarlsen@sfgate.com. Sabin Russell can be reached at sabin@sfgate.com.
Friday, October 03, 2008
Thursday, October 02, 2008
Monday, September 22, 2008
Out-of-control enzyme may trigger endometriosis
A news flash from Stephanie St. James
http://www.myspace.com/stjamesendoawareness
Out-of-control enzyme may trigger endometriosis
Scientists may be one step closer to solving the mystery behind endometriosis — what doctors say is a common health problem for women. In their latest study, scientists at the University of Liverpool in the UK have discovered what may be triggering this condition. Their findings were recently published in the journal Human Reproduction.
The telomeres enable egg cells to continue dividing
© Shutterstock
'Endometriosis occurs when cells of the inner lining of the womb are found growing outside of the uterus,' explained Dr Dharani Hapangama from the Department of Reproductive and Developmental Medicine, University of Liverpool. 'At the time of a woman's menstruation cycle these cells, called endometrial cells, are shed and can be expelled into the abdominal cavity,' he said. 'If these cells continue to live and are implanted in the pelvis and abdomen it can cause severe pain and in serious cases can lead to infertility.'
The telomerase enzyme, found in cells and the inner lining of the womb, patrols the end parts of chromosomes, called telomeres. These telomeres hold the two ends of the chromosomes together and ensure that they stay intact during cell division. The researchers found that telomerase is released by cells in the inner lining of the womb at the beginning and towards the end of the menstrual cycle in women suffering from this condition. Cancer cells also contain this enzyme, which seemingly replicates DNA sequences during cell division in chromosomes, experts say.
The lead researcher went on to say that the team found the telomere to be unusually long in women with endometriosis. 'During menstruation, telomeres normally shorten in length with each cycle of cell division until they reach a certain length at which they can no longer divide,' Dr Hapangama commented. 'The enzyme can extend the length of the telomeres so that they can continue to divide and this can happen in some special cells, such as sperm and egg cells, but not normally in cells that make up the organs of the body.'
'Women who have endometriosis express this enzyme in both the early and late stages of the menstrual cycle which means that the cells will continue to divide and lose their "focus" in supporting the establishment of a pregnancy,' he said. Due to this, the womb's lining 'may be more hostile to an early pregnancy', Dr Hapangama explained. 'The cells that are shed at this late stage in the menstrual cycle may be more "aggressive" and more able to survive and implant outside the uterus, causing pain in the pelvic or abdomen area.'
In general, endometriosis emerges in the lower region of the female pelvis causing extreme pain and discomfort. Around 50% of the cases involve the ovary, and the condition is also responsible for half of the infertility cases.
More than 88 million women worldwide are affected by endometriosis. While the condition affects around 15% of women of reproductive age, up to 4% of the cases are diagnosed in the postmenopausal period.
http://ec.europa.eu/research/headlines/news/article_08_09_18_en.html
http://www.myspace.com/stjamesendoawareness
Out-of-control enzyme may trigger endometriosis
Scientists may be one step closer to solving the mystery behind endometriosis — what doctors say is a common health problem for women. In their latest study, scientists at the University of Liverpool in the UK have discovered what may be triggering this condition. Their findings were recently published in the journal Human Reproduction.
The telomeres enable egg cells to continue dividing
© Shutterstock
'Endometriosis occurs when cells of the inner lining of the womb are found growing outside of the uterus,' explained Dr Dharani Hapangama from the Department of Reproductive and Developmental Medicine, University of Liverpool. 'At the time of a woman's menstruation cycle these cells, called endometrial cells, are shed and can be expelled into the abdominal cavity,' he said. 'If these cells continue to live and are implanted in the pelvis and abdomen it can cause severe pain and in serious cases can lead to infertility.'
The telomerase enzyme, found in cells and the inner lining of the womb, patrols the end parts of chromosomes, called telomeres. These telomeres hold the two ends of the chromosomes together and ensure that they stay intact during cell division. The researchers found that telomerase is released by cells in the inner lining of the womb at the beginning and towards the end of the menstrual cycle in women suffering from this condition. Cancer cells also contain this enzyme, which seemingly replicates DNA sequences during cell division in chromosomes, experts say.
The lead researcher went on to say that the team found the telomere to be unusually long in women with endometriosis. 'During menstruation, telomeres normally shorten in length with each cycle of cell division until they reach a certain length at which they can no longer divide,' Dr Hapangama commented. 'The enzyme can extend the length of the telomeres so that they can continue to divide and this can happen in some special cells, such as sperm and egg cells, but not normally in cells that make up the organs of the body.'
'Women who have endometriosis express this enzyme in both the early and late stages of the menstrual cycle which means that the cells will continue to divide and lose their "focus" in supporting the establishment of a pregnancy,' he said. Due to this, the womb's lining 'may be more hostile to an early pregnancy', Dr Hapangama explained. 'The cells that are shed at this late stage in the menstrual cycle may be more "aggressive" and more able to survive and implant outside the uterus, causing pain in the pelvic or abdomen area.'
In general, endometriosis emerges in the lower region of the female pelvis causing extreme pain and discomfort. Around 50% of the cases involve the ovary, and the condition is also responsible for half of the infertility cases.
More than 88 million women worldwide are affected by endometriosis. While the condition affects around 15% of women of reproductive age, up to 4% of the cases are diagnosed in the postmenopausal period.
http://ec.europa.eu/research/headlines/news/article_08_09_18_en.html
Stephanie'>http://vids.myspace.com/index.cfm?fuseaction=vids.individual&videoid=6466478">Stephanie St. James talking about Endometriosis
Wednesday, September 17, 2008
Doctors Try New Approach To Treating Endometriosis
Sep 11, 2008 6:00 pm US/Eastern
BALTIMORE (WJZ) ― A commonly used treatment for breast cancer proves successful at reducing the pain of an entirely different illness.Healthwatch reporter Kellye Lynn says local doctors are combining two drugs to ease the discomfort of endometriosis.Amy Maddox says the severe pain started when her first period arrived 22 years ago. Every month, Amy was on her back. "Intense pain where I couldn't really even function," said Maddox.An official diagnosis didn't come until Amy turned 24. She had endometriosis."I really had to go on the Internet and look it up and see what it really meant," she said."The best way to define endometriosis is to say that it is the menstrual tissue that grows outside the uterus," said Dr. Fermin Barrueto with Mercy Medical Center.It's a disorder that affects up to 10 percent of women--50 percent of premenopausal woman and more than 85 percent of women who have pelvic pain.The strongest pain medications like narcotics may take care of it for two to three hours, but the pain still comes back.Now doctors have found a way to relieve the pain with a pill. They're combining aromatase inhibitors with the endometriosis drug Lupron. "When you use the combination of these two drugs, you have a better chance," Dr. Barrueto said.
READ MORE HERE
Oh man I would ask lots of questions before even considering it.
The Lupron effect can be horrible and sometimes permanant......thats what happened to me anyhow.
Best wishes to all....
BALTIMORE (WJZ) ― A commonly used treatment for breast cancer proves successful at reducing the pain of an entirely different illness.Healthwatch reporter Kellye Lynn says local doctors are combining two drugs to ease the discomfort of endometriosis.Amy Maddox says the severe pain started when her first period arrived 22 years ago. Every month, Amy was on her back. "Intense pain where I couldn't really even function," said Maddox.An official diagnosis didn't come until Amy turned 24. She had endometriosis."I really had to go on the Internet and look it up and see what it really meant," she said."The best way to define endometriosis is to say that it is the menstrual tissue that grows outside the uterus," said Dr. Fermin Barrueto with Mercy Medical Center.It's a disorder that affects up to 10 percent of women--50 percent of premenopausal woman and more than 85 percent of women who have pelvic pain.The strongest pain medications like narcotics may take care of it for two to three hours, but the pain still comes back.Now doctors have found a way to relieve the pain with a pill. They're combining aromatase inhibitors with the endometriosis drug Lupron. "When you use the combination of these two drugs, you have a better chance," Dr. Barrueto said.
READ MORE HERE
Oh man I would ask lots of questions before even considering it.
The Lupron effect can be horrible and sometimes permanant......thats what happened to me anyhow.
Best wishes to all....
Saturday, September 06, 2008
Find Out about ARD, before you have any surgery!
September is Adhesion Related Disorder Awareness Month.
What are Adhesions?
An ADHESION is a type of scar that forms an abnormal connection between two parts of the body. Adhesions can cause severe clinical problems. For example, adhesions involving the female reproductive organs (ovaries, Fallopian tubes) can and do cause infertility, dyspareunia (painful intercourse) and debilitating pelvic pain. Adhesions involving the bowel can cause bowel obstruction or blockage. Adhesions may form elsewhere such as around the heart, spine and in the hand where they lead to other problems.
Adhesions occur in response to injury of various kinds. For example, non-surgical insults such as endometriosis, infection, chemotherapy, radiation and cancer may damage tissue and initiate ADHESIONS. By far the most common kind of ADHESION is the one that forms after surgery. ADHESIONS typically occur at the site of a surgical procedure although they may also occur elsewhere.
An ADHESION is a type of scar that forms an abnormal connection between two parts of the body. Adhesions can cause severe clinical problems. For example, adhesions involving the female reproductive organs (ovaries, Fallopian tubes) can and do cause infertility, dyspareunia (painful intercourse) and debilitating pelvic pain. Adhesions involving the bowel can cause bowel obstruction or blockage. Adhesions may form elsewhere such as around the heart, spine and in the hand where they lead to other problems.
Adhesions occur in response to injury of various kinds. For example, non-surgical insults such as endometriosis, infection, chemotherapy, radiation and cancer may damage tissue and initiate ADHESIONS. By far the most common kind of ADHESION is the one that forms after surgery. ADHESIONS typically occur at the site of a surgical procedure although they may also occur elsewhere.
Dr. David Wiseman - International Adhesions Society
Please visit these site for advocacy news and general education.
International Adhesion Society
International Adhesion Society
Education helps prevent Adhesions!
Endo headlines
Sheesh, what ever happened to altruism.
As I scan the headlines...I feel like a widget to be profitable to corporate shareholders.
Tara's driveDanbury News Times, CT - 2 hours agoThe common wrong conclusion was that Tara had endometriosis, which occurs when endometrial tissue -- tissue normally found only in the lining of the uterus ...
Neurocrine Shares Edge Up After Promising Drug TestsSan Diego Business Journal, CA - 11 hours ago3 following positive mid-stage results for elagolix, a drug candidate aimed at treating endometriosis. Neurocrine shares, traded under the symbol NBIX on ...
Zacks Bull and Bear of the Day Highlights: Allegheny Energy ...PR-Inside.com (Pressemitteilung), Austria - Sep 5, 2008This encouraging data for the treatment of endometriosis should lead to the signing of a major partnership for pivotal trials in 2009. ...AYE - NVTL - HRB
Reunion connects now-healthy children with their medical staffLa Vista Sun, Ne - Sep 5, 2008Because of Colleen's severe endometriosis, the couple, who has lived in Papillion for five years, tried in vitro fertilization, and Colleen finally ...
High Growth Forecasted for the World Endoscopy Systems MarketMarketWatch - Sep 4, 2008... Ovarian Laparoscopy II-32 Endometriosis II-32 Tubal Ligation II-32 Vagina Creation II-33 Laparoscopic Myomectomies II-33 Ovarian Cystectomy II-33 Female ...
Androstenedione Up-Regulation of Endometrial Aromatase Expression ...Journal of Clinical Endocrinology and Metabolism, MD - Sep 4, 2008... in endometrial cells disseminated into the peritoneal cavity may enhance their survival via local estrogen synthesis, which may lead to endometriosis. ...
Extracellularly Signal-Regulated Kinase Activity in the Human ...Journal of Clinical Endocrinology and Metabolism, MD - Sep 4, 2008Context: Endometriosis is an estrogen-dependent disease characterized by the presence of endometrial tissue outside of the uterine cavity, causing pelvic ...
Neurocrine reports positive results from Phase II endometriosis trialTrading Markets (press release), CA - Sep 4, 2008The Petal study enrolled 252 patients, with a confirmed diagnosis of endometriosis, into three treatment groups - elagolix 150mg once daily, elagolix 75mg ...NBIX - OTC:CMTX
As I scan the headlines...I feel like a widget to be profitable to corporate shareholders.
Tara's driveDanbury News Times, CT - 2 hours agoThe common wrong conclusion was that Tara had endometriosis, which occurs when endometrial tissue -- tissue normally found only in the lining of the uterus ...
Neurocrine Shares Edge Up After Promising Drug TestsSan Diego Business Journal, CA - 11 hours ago3 following positive mid-stage results for elagolix, a drug candidate aimed at treating endometriosis. Neurocrine shares, traded under the symbol NBIX on ...
Zacks Bull and Bear of the Day Highlights: Allegheny Energy ...PR-Inside.com (Pressemitteilung), Austria - Sep 5, 2008This encouraging data for the treatment of endometriosis should lead to the signing of a major partnership for pivotal trials in 2009. ...AYE - NVTL - HRB
Reunion connects now-healthy children with their medical staffLa Vista Sun, Ne - Sep 5, 2008Because of Colleen's severe endometriosis, the couple, who has lived in Papillion for five years, tried in vitro fertilization, and Colleen finally ...
High Growth Forecasted for the World Endoscopy Systems MarketMarketWatch - Sep 4, 2008... Ovarian Laparoscopy II-32 Endometriosis II-32 Tubal Ligation II-32 Vagina Creation II-33 Laparoscopic Myomectomies II-33 Ovarian Cystectomy II-33 Female ...
Androstenedione Up-Regulation of Endometrial Aromatase Expression ...Journal of Clinical Endocrinology and Metabolism, MD - Sep 4, 2008... in endometrial cells disseminated into the peritoneal cavity may enhance their survival via local estrogen synthesis, which may lead to endometriosis. ...
Extracellularly Signal-Regulated Kinase Activity in the Human ...Journal of Clinical Endocrinology and Metabolism, MD - Sep 4, 2008Context: Endometriosis is an estrogen-dependent disease characterized by the presence of endometrial tissue outside of the uterine cavity, causing pelvic ...
Neurocrine reports positive results from Phase II endometriosis trialTrading Markets (press release), CA - Sep 4, 2008The Petal study enrolled 252 patients, with a confirmed diagnosis of endometriosis, into three treatment groups - elagolix 150mg once daily, elagolix 75mg ...NBIX - OTC:CMTX
Thursday, August 28, 2008
Headlines: Possible Cause Of Endometriosis Identified
Possible Cause Of Endometriosis Identified
Science Daily (press release) - Aug 5, 20085, 2008) — Scientists at the University of Liverpool have identified an enzyme that could be responsible for a condition called endometriosis – the most ...
Secret to damage caused by endometriosis unlocked Telegraph.co.uk
Breakthrough for endometriosis sufferers as discovery offers hope ... Daily Mail
Clue to cause of womb condition
BBC News
all 24 news articles »
Science Daily (press release) - Aug 5, 20085, 2008) — Scientists at the University of Liverpool have identified an enzyme that could be responsible for a condition called endometriosis – the most ...
Secret to damage caused by endometriosis unlocked Telegraph.co.uk
Breakthrough for endometriosis sufferers as discovery offers hope ... Daily Mail
Clue to cause of womb condition
BBC News
all 24 news articles »
Wednesday, August 27, 2008
Everything you always wanted to know about menopause but were afraid (or forgot) to ask
This article features a broad array of information.
Included as issues are bone density to heavy bleeding, even how it effects your teeth.
Also included:
Signs and symptoms of perimenopause
Signs that you are in perimenopause include:
Irregular menstrual periods.
Less frequent, light menstrual periods.
Heavier menstrual periods than you are used to having.
Symptoms of menopause
Symptoms related to menopause are caused by changing or dropping hormone levels and usually end 1 or 2 years after menopause. Some women continue to have symptoms for 5 or more years afterward. Menopause symptoms include:
Hot flashes.
Sleep disturbances (insomnia).
Emotional changes, such as mood swings or irritability.
A change in sexual interest or response.
Problems with concentration and memory that are linked to sleep loss and fluctuating hormones (not a permanent sign of aging).5
Headaches.
Rapid, irregular heartbeats (heart palpitations).
Generalized itching.
Menopause caused by surgery, chemotherapy, or radiation therapy can cause more severe symptoms than usual.6 Preexisting conditions such as depression, anxiety, sleep problems, or irritability can get worse during the perimenopausal transition.
When to Call a Doctor
During perimenopause or postmenopause, call your health professional about:
Menstrual periods that are unusually heavy, irregular, or prolonged (1½ to 2 times longer than normal).
Bleeding between menstrual periods, when periods have been regular.
Renewed bleeding after having no periods for 6 months or more.
Unexplained bleeding while you are taking hormones.
Perimenopause symptoms, such as insomnia, hot flashes, or mood swings, that aren't responding to home treatment and are interfering with your sleep or daily life.
Vaginal pain or dryness that does not improve with home treatment, or you have signs of a urinary tract infection.
If you have concerns about osteoporosis risk and prevention, talk to your health professional during your next office visit.
For more information, see the topics Abnormal Vaginal Bleeding, Dysfunctional Uterine Bleeding, and Osteoporosis.
Click here for even more!
Included as issues are bone density to heavy bleeding, even how it effects your teeth.
Also included:
Signs and symptoms of perimenopause
Signs that you are in perimenopause include:
Irregular menstrual periods.
Less frequent, light menstrual periods.
Heavier menstrual periods than you are used to having.
Symptoms of menopause
Symptoms related to menopause are caused by changing or dropping hormone levels and usually end 1 or 2 years after menopause. Some women continue to have symptoms for 5 or more years afterward. Menopause symptoms include:
Hot flashes.
Sleep disturbances (insomnia).
Emotional changes, such as mood swings or irritability.
A change in sexual interest or response.
Problems with concentration and memory that are linked to sleep loss and fluctuating hormones (not a permanent sign of aging).5
Headaches.
Rapid, irregular heartbeats (heart palpitations).
Generalized itching.
Menopause caused by surgery, chemotherapy, or radiation therapy can cause more severe symptoms than usual.6 Preexisting conditions such as depression, anxiety, sleep problems, or irritability can get worse during the perimenopausal transition.
When to Call a Doctor
During perimenopause or postmenopause, call your health professional about:
Menstrual periods that are unusually heavy, irregular, or prolonged (1½ to 2 times longer than normal).
Bleeding between menstrual periods, when periods have been regular.
Renewed bleeding after having no periods for 6 months or more.
Unexplained bleeding while you are taking hormones.
Perimenopause symptoms, such as insomnia, hot flashes, or mood swings, that aren't responding to home treatment and are interfering with your sleep or daily life.
Vaginal pain or dryness that does not improve with home treatment, or you have signs of a urinary tract infection.
If you have concerns about osteoporosis risk and prevention, talk to your health professional during your next office visit.
For more information, see the topics Abnormal Vaginal Bleeding, Dysfunctional Uterine Bleeding, and Osteoporosis.
Click here for even more!
Wednesday, August 13, 2008
Wednesday, August 06, 2008
Secret to endometriosis unlocked by scientists
Scientists may have solved the riddle of a mysterious womb complaint that causes infertility and pain for millions of women in the UK.
By Daily Telegraph Reporter Last Updated: 6:47PM
BST 05 Aug 2008
Endometriosis results in patches of the womb's inner lining growing in other parts of the body.
Around two million women in the UK are affected by the condition, which can cause severe pain, heavy periods and infertility.
The precise cause remains unknown but scientists have uncovered how it may cause infertility in some sufferers.
The team at University of Liverpool have identified an enzyme that could be responsible for the condition.
Telomerase is released by cells in the inner lining of the womb during the later stages of the menstrual cycle in women affected by endometriosis.
The enzyme found in cells that divide frequently, including cancer cells.
Around two million women in the UK are affected by the condition, which can cause severe pain, heavy periods and infertility.
The precise cause remains unknown but scientists have uncovered how it may cause infertility in some sufferers.
The team at University of Liverpool have identified an enzyme that could be responsible for the condition.
Telomerase is released by cells in the inner lining of the womb during the later stages of the menstrual cycle in women affected by endometriosis.
The enzyme found in cells that divide frequently, including cancer cells.
Click here to Read the Rest
By Daily Telegraph Reporter Last Updated: 6:47PM
BST 05 Aug 2008
Endometriosis results in patches of the womb's inner lining growing in other parts of the body.
Around two million women in the UK are affected by the condition, which can cause severe pain, heavy periods and infertility.
The precise cause remains unknown but scientists have uncovered how it may cause infertility in some sufferers.
The team at University of Liverpool have identified an enzyme that could be responsible for the condition.
Telomerase is released by cells in the inner lining of the womb during the later stages of the menstrual cycle in women affected by endometriosis.
The enzyme found in cells that divide frequently, including cancer cells.
Around two million women in the UK are affected by the condition, which can cause severe pain, heavy periods and infertility.
The precise cause remains unknown but scientists have uncovered how it may cause infertility in some sufferers.
The team at University of Liverpool have identified an enzyme that could be responsible for the condition.
Telomerase is released by cells in the inner lining of the womb during the later stages of the menstrual cycle in women affected by endometriosis.
The enzyme found in cells that divide frequently, including cancer cells.
Click here to Read the Rest
Sunday, June 22, 2008
Latest Endo News
Aromatase Inhibitors May Relieve Endometriosis-Associated Pain: ReviewMedscape (subscription) - Jun 20, 2008Symptoms include pelvic pain, dyspareunia, and painful bowel movements from cyclical bleeding and inflammation, which result in the formation of adhesions ...
Massage offers physical and mental benefits
Statesman Journal, OR - Jun 19, 2008... reduce scar tissue formation, improves circulation by increasing blood and nutrient flow to tissues, and reduce post surgery adhesions and swelling. ...
NeoMend Receives FDA Panel's Recommendation for Approval of ProGEL ...Earthtimes (press release), UK - Jun 17, 2008... is also developing a similar product, ProGEL-AB, for sealing surgical wound sites while also helping prevent the formation of post-surgical adhesions. ... Similar Outcomes for Patients After Laparoscopic and Open ...Abkhazia, CA - Jun 16, 2008... of incisional hernia, the number of reoperations for incisional hernia, or the number of reoperations for intraperitoneal adhesions, the authors report. ...
Haemacure Raises $7.8 Million and is Fully Funded Beyond First ...PharmaLive.com (press release), PA - Jun 16, 2008Follow-on development will focus on surgical hemostats, wound healing, adhesion prevention, regenerative medicine, drug delivery and combinations with ...TSE:HAE Haemacure Raises $7.8 Million and is Fully Funded Beyond First ...istockAnalyst.com, OR - Jun 16, 2008Follow-on development will focus on surgical hemostats, wound healing,adhesion prevention, regenerative medicine, drug delivery and combinationswith ...TSE:HAE
Massage offers physical and mental benefits
Statesman Journal, OR - Jun 19, 2008... reduce scar tissue formation, improves circulation by increasing blood and nutrient flow to tissues, and reduce post surgery adhesions and swelling. ...
NeoMend Receives FDA Panel's Recommendation for Approval of ProGEL ...Earthtimes (press release), UK - Jun 17, 2008... is also developing a similar product, ProGEL-AB, for sealing surgical wound sites while also helping prevent the formation of post-surgical adhesions. ... Similar Outcomes for Patients After Laparoscopic and Open ...Abkhazia, CA - Jun 16, 2008... of incisional hernia, the number of reoperations for incisional hernia, or the number of reoperations for intraperitoneal adhesions, the authors report. ...
Haemacure Raises $7.8 Million and is Fully Funded Beyond First ...PharmaLive.com (press release), PA - Jun 16, 2008Follow-on development will focus on surgical hemostats, wound healing, adhesion prevention, regenerative medicine, drug delivery and combinations with ...TSE:HAE Haemacure Raises $7.8 Million and is Fully Funded Beyond First ...istockAnalyst.com, OR - Jun 16, 2008Follow-on development will focus on surgical hemostats, wound healing,adhesion prevention, regenerative medicine, drug delivery and combinationswith ...TSE:HAE
Mom's the childish, egocentric oneSunHerald.com, MS - 9 hours agoI am a 6-foot-tall woman, and as a result of endometriosis, I have facial hair and a muscular build, too. After finding the right makeup, ...
Nitro dioxin report flawedCharleston Gazette, USA - 10 hours agoDioxin has been linked to cancer, birth defects, learning disabilities, endometriosis, infertility and suppressed immune functions. ...
Aromatase Inhibitors May Relieve Endometriosis-Associated Pain: ReviewMedscape (subscription) - Jun 20, 2008Describe the evidence supporting the use of aromatase inhibitors for endometriosis. Identify limitations of studies on the use of aromatase inhibitors for ...
Report On Presentations From The European Society For The Study Of ...Medical News Today (press release), UK - Jun 20, 2008Dr. Andrey Zaitcev and coworkers from Moscow presented a series of 19 women diagnosed with chronic pelvic pain from endometriosis who were subsequently ...
'Color Purple' -- or Is That Blue-and-White?Jewish Exponent, PA - Jun 19, 2008... including one which serves her as a spokeswoman in the battle against endometriosis, a gynecological problem she has dealt with in her life. ...
Nitro dioxin report flawedCharleston Gazette, USA - 10 hours agoDioxin has been linked to cancer, birth defects, learning disabilities, endometriosis, infertility and suppressed immune functions. ...
Aromatase Inhibitors May Relieve Endometriosis-Associated Pain: ReviewMedscape (subscription) - Jun 20, 2008Describe the evidence supporting the use of aromatase inhibitors for endometriosis. Identify limitations of studies on the use of aromatase inhibitors for ...
Report On Presentations From The European Society For The Study Of ...Medical News Today (press release), UK - Jun 20, 2008Dr. Andrey Zaitcev and coworkers from Moscow presented a series of 19 women diagnosed with chronic pelvic pain from endometriosis who were subsequently ...
'Color Purple' -- or Is That Blue-and-White?Jewish Exponent, PA - Jun 19, 2008... including one which serves her as a spokeswoman in the battle against endometriosis, a gynecological problem she has dealt with in her life. ...
Friday, June 20, 2008
Fluid and pharmacological agents for adhesion prevention after gynaecological surgery
Fluid and pharmacological agents for adhesion prevention after gynaecological surgery
Fluid and pharmacological agents for adhesion prevention after gynaecological surgeryThe use of fluids and pharmacological agents (medicinal drugs) to prevent the formation of adhesions (scar tissue) that may interfere with becoming pregnant after surgery of the female pelvis.Adhesion formation is a condition in which bodily tissues that are normally separate grow together. This can occur after surgical procedures such as operations on the female pelvis to remove a cyst, treat endometriosis, remove a tubal pregnancy, or remove a fibroid (a benign tumour of the womb). This scar tissue can have serious effects on the woman's future fertility as it can lead to blockage of her tubes. Careful tissue handling at the time of surgery and control of the blood loss are important ways of reducing scar tissue, however, over the years other methods have been developed to minimise the risk of scar tissue formation. Surgeons have tried using different types of drugs or leaving different types of fluids inside the pelvis at the end of surgery to prevent tissue surfaces from sticking to each other. Fluids include dextran, icodextrin (Adept), SprayGel, and fluids containing the chemical hyaluronic acid (Intergel, auto-crosslinked hyaluronic acid, Sepracoat). Drugs that have been tried include steroids (anti-inflammatory drug), the anti-coagulant heparin, promethazine, and noxytioline.This review aimed to evaluate the role of these different agents in the prevention of adhesion formation. The results showed that there is currently insufficient evidence to recommend the use of steroids, icodextrin, SprayGel or dextran. The review did show that fluids that contained hyaluronic acid may help lower the chance of scar tissue forming; however, more studies are needed to confirm this. There are also some major safety issues concerning the use of one of these agents (Intergel), which has been withdrawn from the market due to reports of serious side effects such as allergic reactions and pain.A major problem with studies in this review is that most of them did not look at the rate of pregnancy following the use of these substances. Since the occurrence of pregnancy is the gold standard for measuring how well these agents work to preserve fertility, it is important that future studies take this into consideration.http://www.cochrane.org/reviews/en/ab001298.htmlMain resultsThere is no evidence of benefit from the use of steroids, dextran or other pharmacological agents in any of the outcomes. The use of hyaluronic acid agents may decrease adhesion formation (OR 0.31, 95% CI 0.19 to 0.51) and prevent the deterioration of pre-existing adhesions (OR 0.28 (95% CI 0.12 to 0.66). There is insufficient evidence for the use of icodextrin 4% or SprayGel as adhesion-preventing agents. None of the studied agents has been shown to improve the pregnancy rate when used as an adjunct during pelvic surgery.Authors' conclusionsThe current evidence for the use of fluid and pharmacological agents for the prevention of adhesions is limited. There is no evidence on any benefit for improving pregnancy outcomes when pharmacological and fluid agents are used as an adjunct during pelvic surgery.There is insufficient evidence for the use of the following agents: steroids, icodextrin 4%, SprayGel and dextran in improving adhesions following surgery.There is some evidence that hyaluronic acid agents may decrease the proportion of adhesions and prevent the deterioration of pre existing adhesions. However, due to the limited number of studies available, this evidence should be interpreted with caution and further studies are needed.Full studyhttp://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001298/frame.htmland who do they as one of the references??????METTLER!!!!
Posted by IHRT at 6/20/2008 01:26:00 PM 0 comments Links to this post
Labels: Adept, adhesion barrier, adhesion prevention, Adhesion related disorders, adhesions, endometriosis, postoperative complications, SprayGel, surgeons, surgery
Fluid and pharmacological agents for adhesion prevention after gynaecological surgeryThe use of fluids and pharmacological agents (medicinal drugs) to prevent the formation of adhesions (scar tissue) that may interfere with becoming pregnant after surgery of the female pelvis.Adhesion formation is a condition in which bodily tissues that are normally separate grow together. This can occur after surgical procedures such as operations on the female pelvis to remove a cyst, treat endometriosis, remove a tubal pregnancy, or remove a fibroid (a benign tumour of the womb). This scar tissue can have serious effects on the woman's future fertility as it can lead to blockage of her tubes. Careful tissue handling at the time of surgery and control of the blood loss are important ways of reducing scar tissue, however, over the years other methods have been developed to minimise the risk of scar tissue formation. Surgeons have tried using different types of drugs or leaving different types of fluids inside the pelvis at the end of surgery to prevent tissue surfaces from sticking to each other. Fluids include dextran, icodextrin (Adept), SprayGel, and fluids containing the chemical hyaluronic acid (Intergel, auto-crosslinked hyaluronic acid, Sepracoat). Drugs that have been tried include steroids (anti-inflammatory drug), the anti-coagulant heparin, promethazine, and noxytioline.This review aimed to evaluate the role of these different agents in the prevention of adhesion formation. The results showed that there is currently insufficient evidence to recommend the use of steroids, icodextrin, SprayGel or dextran. The review did show that fluids that contained hyaluronic acid may help lower the chance of scar tissue forming; however, more studies are needed to confirm this. There are also some major safety issues concerning the use of one of these agents (Intergel), which has been withdrawn from the market due to reports of serious side effects such as allergic reactions and pain.A major problem with studies in this review is that most of them did not look at the rate of pregnancy following the use of these substances. Since the occurrence of pregnancy is the gold standard for measuring how well these agents work to preserve fertility, it is important that future studies take this into consideration.http://www.cochrane.org/reviews/en/ab001298.htmlMain resultsThere is no evidence of benefit from the use of steroids, dextran or other pharmacological agents in any of the outcomes. The use of hyaluronic acid agents may decrease adhesion formation (OR 0.31, 95% CI 0.19 to 0.51) and prevent the deterioration of pre-existing adhesions (OR 0.28 (95% CI 0.12 to 0.66). There is insufficient evidence for the use of icodextrin 4% or SprayGel as adhesion-preventing agents. None of the studied agents has been shown to improve the pregnancy rate when used as an adjunct during pelvic surgery.Authors' conclusionsThe current evidence for the use of fluid and pharmacological agents for the prevention of adhesions is limited. There is no evidence on any benefit for improving pregnancy outcomes when pharmacological and fluid agents are used as an adjunct during pelvic surgery.There is insufficient evidence for the use of the following agents: steroids, icodextrin 4%, SprayGel and dextran in improving adhesions following surgery.There is some evidence that hyaluronic acid agents may decrease the proportion of adhesions and prevent the deterioration of pre existing adhesions. However, due to the limited number of studies available, this evidence should be interpreted with caution and further studies are needed.Full studyhttp://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001298/frame.htmland who do they as one of the references??????METTLER!!!!
Posted by IHRT at 6/20/2008 01:26:00 PM 0 comments Links to this post
Labels: Adept, adhesion barrier, adhesion prevention, Adhesion related disorders, adhesions, endometriosis, postoperative complications, SprayGel, surgeons, surgery
Wednesday, May 28, 2008
Bid to treat painful disease
Bid to treat painful disease
A REPRODUCTIVE science unit in Edinburgh has teamed up with researchers from Aberdeen University to find new treatments for a painful disease that afflicts an estimated two million women in the UK each year.
The Medical Research Council Human Reproductive Sciences Unit in Edinburgh has set out to try to discover clues to the causes of endometriosis, a condition in which the cells that line the womb are found elsewhere in the body.It costs the economy at least £2.8 billion a year in lost working days and can also affect fertility.
http://edinburghnews.scotsman.com/health/Bid-to-treat-painful-disease.4121709.jp
A REPRODUCTIVE science unit in Edinburgh has teamed up with researchers from Aberdeen University to find new treatments for a painful disease that afflicts an estimated two million women in the UK each year.
The Medical Research Council Human Reproductive Sciences Unit in Edinburgh has set out to try to discover clues to the causes of endometriosis, a condition in which the cells that line the womb are found elsewhere in the body.It costs the economy at least £2.8 billion a year in lost working days and can also affect fertility.
http://edinburghnews.scotsman.com/health/Bid-to-treat-painful-disease.4121709.jp
Friday, May 23, 2008
On the Teen Scene:Endometriosis: Painful, but Treatable
by Dixie Farley
"The pain was so sharp I thought I'd ruptured my appendix, but the doctor said, no, it wasn't that. It was between my periods, so I didn't connect it with menstruation. I was 16.
"Over the next 10 years, I had more and more of these 'pain attacks,' and my periods gradually became heavier and more painful.
"When I was pregnant with my first child, I was virtually pain-free. But shortly after he was born, each month around ovulation, I went to bed in tears from horrible pain. And I bled so much during menstruation I didn't dare leave the house. I went back to the doctor. It was endometriosis."
--A woman from Des Moines, Iowa
Endometriosis is a mysterious, often painful, and disabling condition in which fragments of the lining of the uterus (womb) become embedded, or implanted, elsewhere in the body.
Of the more than 3,000 patients registered with the research program of the International Endometriosis Association in Milwaukee, 41 percent report having symptoms as teenagers. About 5 million American women and girls, some as young as 11, have endometriosis, according to the association.
"These girls have terrible pain," says Lyle Breitkopf, M.D., a gynecologist in New York City. "Typically, they come to the school nurse month after month--maybe six to eight of their 12 menstrual cycles--needing something for pain or being sent home vomiting, writhing on the floor."
For the woman from Des Moines, 25 years with endometriosis led to removal of her uterus, fallopian tubes, and ovaries a number of years ago. For many women today, new medicine and less drastic surgery reduce endometriosis symptoms and preserve reproductive organs.The Food and Drug Administration has approved several drugs to treat endometriosis and regulates medical devices, such as lasers, used in surgical treatment.
A woman who thinks she may have endometriosis should be examined by a gynecologist. The sooner treatment begins, the better it is for the patients, says Breitkopf. "When we find them at an early stage, we can arrest the condition more easily and keep after it so it doesn't progress as far."
Doctors don't know why endometriosis only strikes certain women.
Some probably inherit it, says Breitkopf. "I've seen it in sisters, including identical twins, and in grandmother-mother-daughter situations."
According to Robert Badwey, M.D., a gynecologist in suburban Washington, D.C., "For whatever reason--greater incidence, better diagnostic techniques, or both--we're much more aware of endometriosis now than even a few years ago."
What's Happening in the Body?
Normally, an increased level of hormones each month triggers the release of an egg from the ovary. Finger-like tissues on one of the fallopian tubes grasp the egg, and tiny hair-like "cilia" inside the tube transport it toward the uterus. When the egg is not fertilized, the uterine lining breaks down and is shed during menstruation.
The abnormal implants of endometriosis are not in the uterus, but they respond to hormonal changes controlling menstruation. Like the uterine lining, these fragments build tissue each month, then break down and bleed. Unlike blood from the lining, however, blood from implants outside the uterus has no way to leave the body. Instead, it is absorbed by surrounding tissue, which can be painful.
As the cycle recurs month after month, the implants may get bigger. They may seed new implants and form scar tissue and adhesions (scarring that connects one organ to another). Sometimes, a collection of blood called a sac or cyst forms. If a cyst ruptures, it often causes excruciating pain.
Symptoms vary from patient to patient. Severity of symptoms frequently has little to do with the extent of the implants. For instance, some women with just a few implants have severe pain, while some with many implants have little or no pain.
For some, pain starts before or during menstruation and gets worse as the period progresses. Others report pain at a variety of times during the month. There may be a sharp pain at ovulation when the egg, trying to move into the fallopian tube, causes a cyst on the ovary to burst. (Many women normally feel a twinge of pain at ovulation. Pain caused by a ruptured endometriosis cyst is severe.)
Patients whose implants affect the bladder or intestines often report painful urination or bowel movements and, sometimes, blood in the urine or stool.
Endometriosis sometimes causes premenstrual staining and, as the period progresses, heavy menstrual flow.
Often, endometriosis remains hidden a long time. A symptom such as pain at menstruation may not be seen as unusual, explains Mary Lou Ballweg, executive director of the Endometriosis Association.
"Perhaps a young woman is told by Mom, who had the same problems, that menstrual pain is normal," Ballweg says. "So she just lives with it and doesn't see a doctor until the symptoms become unbearable. Some young women with endometriosis have apparently normal menstrual periods for years before having discomfort and pain. Others report they've nearly always had difficult periods."
As many as 30 percent of women who report infertility problems have endometriosis.
Severe endometriosis can lead to infertility in various ways. In the ovaries, it can produce cysts that prevent the egg's release. In the fallopian tubes, implants can block the passage of the egg. Also, adhesions can fix ovaries and tubes in place so that projections on the tubes can't grasp the egg and move it into the tube. The effect of mild endometriosis on infertility is less clear.
Women with endometriosis may have a higher rate of "ectopic" pregnancy, a potentially life-threatening condition in which the fertilized egg begins to develop outside the womb.
The most common way to see whether a woman has endometriosis is by surgical examination using laparoscopy, a fairly simple procedure usually done without an overnight hospital stay. The doctor makes a tiny incision and inserts a lighted, flexible, telescope-like device called a laparoscope that allows a close look at the pelvis and internal organs. However, sometimes the implants themselves can only be seen through microscopic evaluation of biopsy specimens.
Drug Treatment
Drugs for endometriosis should not be taken by women who are, or who may be, pregnant.
The earliest drug approved to treat endometriosis was Danocrine (danazol), a synthetic steroid related to the hormone testosterone. Taken orally, in pill form, Danocrine changes endometrial tissue, shrinking and eliminating implants in some cases. Side effects include fluid retention, weight gain, and masculinizing effects such as voice change, hairiness, and reduction of breast size. Other side effects include menstrual irregularities, hot flashes, and vaginal dryness.
Other drugs, related to gonadotropin-releasing hormone (GnRH), act in a different way to decrease the hormones that make abnormal implants grow. One version is a nasal spray called Synarel (nafarelin acetate). In clinical studies, Synarel, at 400 or 800 micrograms a day (within the prescribed dosage range), was comparable to Danocrine at 800 milligrams a day (the recommended dosage) in relieving the clinical symptoms of endometriosis (such as pain) and in reducing the size of implants. Side effects include non-menstrual vaginal bleeding or ovarian cysts during the first two months of use, cessation of menstruation, hot flashes, headaches, decreased sex drive, vaginal dryness, acne, reduction in breast size, and a small loss in bone density. In clinical trials, about 10 percent of the patients experience nasal irritation from the spray.
Other drugs approved for treatment of endometriosis that are chemically related to Synarel include Lupron Depot (leuprolide acetate), a drug injected monthly into muscle, and Zoladex (goserelin acetate implant), which is injected under the skin of the upper abdomen. These drugs don't cause nasal irritation, but otherwise their side effects are similar to those of Synarel, and their effectiveness is also similar.
Women taking endometriosis drugs need to watch for problems such as difficulty breathing or chest or leg pain, which may indicate a blood clot and should be reported to the doctor immediately. Other possible severe side effects include irregular heart rhythms. Frequent checkups are needed to monitor effects such as possible thinning of the bones. A patient should immediately report any new or worsened symptoms to the doctor. However, it's normal for endometriosis symptoms to temporarily worsen when a woman begins taking medicine.
Surgery
Sometimes medicine is not enough. Surgery may be needed to remove diseased tissue or to correct misaligned organs.
One method to remove diseased tissue combines laparoscopy with laser surgery. The laser is connected to the laparoscope and positioned so that its intense light beam is directed through the laparoscope onto the tissue to destroy it. The procedure usually is done without an overnight hospital stay and requires only about a week's recovery time at home.
Recurrence rates after treatment need further study, Ballweg says.
The monthly pain and heavy menstrual periods of chronic endometriosis can be frustrating and painful, and can lead to conceiving and infertility problems. But today, with prompt diagnosis and treatment, a young woman's life can often return to normal.
Dixie Farley is a staff writer for FDA Consumer.
For more information, contact:International Endometriosis Association 8585 N. 76th PlaceMilwaukee, WI 532231-800-992-3636
Publication No. (FDA) 93-1205
"The pain was so sharp I thought I'd ruptured my appendix, but the doctor said, no, it wasn't that. It was between my periods, so I didn't connect it with menstruation. I was 16.
"Over the next 10 years, I had more and more of these 'pain attacks,' and my periods gradually became heavier and more painful.
"When I was pregnant with my first child, I was virtually pain-free. But shortly after he was born, each month around ovulation, I went to bed in tears from horrible pain. And I bled so much during menstruation I didn't dare leave the house. I went back to the doctor. It was endometriosis."
--A woman from Des Moines, Iowa
Endometriosis is a mysterious, often painful, and disabling condition in which fragments of the lining of the uterus (womb) become embedded, or implanted, elsewhere in the body.
Of the more than 3,000 patients registered with the research program of the International Endometriosis Association in Milwaukee, 41 percent report having symptoms as teenagers. About 5 million American women and girls, some as young as 11, have endometriosis, according to the association.
"These girls have terrible pain," says Lyle Breitkopf, M.D., a gynecologist in New York City. "Typically, they come to the school nurse month after month--maybe six to eight of their 12 menstrual cycles--needing something for pain or being sent home vomiting, writhing on the floor."
For the woman from Des Moines, 25 years with endometriosis led to removal of her uterus, fallopian tubes, and ovaries a number of years ago. For many women today, new medicine and less drastic surgery reduce endometriosis symptoms and preserve reproductive organs.The Food and Drug Administration has approved several drugs to treat endometriosis and regulates medical devices, such as lasers, used in surgical treatment.
A woman who thinks she may have endometriosis should be examined by a gynecologist. The sooner treatment begins, the better it is for the patients, says Breitkopf. "When we find them at an early stage, we can arrest the condition more easily and keep after it so it doesn't progress as far."
Doctors don't know why endometriosis only strikes certain women.
Some probably inherit it, says Breitkopf. "I've seen it in sisters, including identical twins, and in grandmother-mother-daughter situations."
According to Robert Badwey, M.D., a gynecologist in suburban Washington, D.C., "For whatever reason--greater incidence, better diagnostic techniques, or both--we're much more aware of endometriosis now than even a few years ago."
What's Happening in the Body?
Normally, an increased level of hormones each month triggers the release of an egg from the ovary. Finger-like tissues on one of the fallopian tubes grasp the egg, and tiny hair-like "cilia" inside the tube transport it toward the uterus. When the egg is not fertilized, the uterine lining breaks down and is shed during menstruation.
The abnormal implants of endometriosis are not in the uterus, but they respond to hormonal changes controlling menstruation. Like the uterine lining, these fragments build tissue each month, then break down and bleed. Unlike blood from the lining, however, blood from implants outside the uterus has no way to leave the body. Instead, it is absorbed by surrounding tissue, which can be painful.
As the cycle recurs month after month, the implants may get bigger. They may seed new implants and form scar tissue and adhesions (scarring that connects one organ to another). Sometimes, a collection of blood called a sac or cyst forms. If a cyst ruptures, it often causes excruciating pain.
Symptoms vary from patient to patient. Severity of symptoms frequently has little to do with the extent of the implants. For instance, some women with just a few implants have severe pain, while some with many implants have little or no pain.
For some, pain starts before or during menstruation and gets worse as the period progresses. Others report pain at a variety of times during the month. There may be a sharp pain at ovulation when the egg, trying to move into the fallopian tube, causes a cyst on the ovary to burst. (Many women normally feel a twinge of pain at ovulation. Pain caused by a ruptured endometriosis cyst is severe.)
Patients whose implants affect the bladder or intestines often report painful urination or bowel movements and, sometimes, blood in the urine or stool.
Endometriosis sometimes causes premenstrual staining and, as the period progresses, heavy menstrual flow.
Often, endometriosis remains hidden a long time. A symptom such as pain at menstruation may not be seen as unusual, explains Mary Lou Ballweg, executive director of the Endometriosis Association.
"Perhaps a young woman is told by Mom, who had the same problems, that menstrual pain is normal," Ballweg says. "So she just lives with it and doesn't see a doctor until the symptoms become unbearable. Some young women with endometriosis have apparently normal menstrual periods for years before having discomfort and pain. Others report they've nearly always had difficult periods."
As many as 30 percent of women who report infertility problems have endometriosis.
Severe endometriosis can lead to infertility in various ways. In the ovaries, it can produce cysts that prevent the egg's release. In the fallopian tubes, implants can block the passage of the egg. Also, adhesions can fix ovaries and tubes in place so that projections on the tubes can't grasp the egg and move it into the tube. The effect of mild endometriosis on infertility is less clear.
Women with endometriosis may have a higher rate of "ectopic" pregnancy, a potentially life-threatening condition in which the fertilized egg begins to develop outside the womb.
The most common way to see whether a woman has endometriosis is by surgical examination using laparoscopy, a fairly simple procedure usually done without an overnight hospital stay. The doctor makes a tiny incision and inserts a lighted, flexible, telescope-like device called a laparoscope that allows a close look at the pelvis and internal organs. However, sometimes the implants themselves can only be seen through microscopic evaluation of biopsy specimens.
Drug Treatment
Drugs for endometriosis should not be taken by women who are, or who may be, pregnant.
The earliest drug approved to treat endometriosis was Danocrine (danazol), a synthetic steroid related to the hormone testosterone. Taken orally, in pill form, Danocrine changes endometrial tissue, shrinking and eliminating implants in some cases. Side effects include fluid retention, weight gain, and masculinizing effects such as voice change, hairiness, and reduction of breast size. Other side effects include menstrual irregularities, hot flashes, and vaginal dryness.
Other drugs, related to gonadotropin-releasing hormone (GnRH), act in a different way to decrease the hormones that make abnormal implants grow. One version is a nasal spray called Synarel (nafarelin acetate). In clinical studies, Synarel, at 400 or 800 micrograms a day (within the prescribed dosage range), was comparable to Danocrine at 800 milligrams a day (the recommended dosage) in relieving the clinical symptoms of endometriosis (such as pain) and in reducing the size of implants. Side effects include non-menstrual vaginal bleeding or ovarian cysts during the first two months of use, cessation of menstruation, hot flashes, headaches, decreased sex drive, vaginal dryness, acne, reduction in breast size, and a small loss in bone density. In clinical trials, about 10 percent of the patients experience nasal irritation from the spray.
Other drugs approved for treatment of endometriosis that are chemically related to Synarel include Lupron Depot (leuprolide acetate), a drug injected monthly into muscle, and Zoladex (goserelin acetate implant), which is injected under the skin of the upper abdomen. These drugs don't cause nasal irritation, but otherwise their side effects are similar to those of Synarel, and their effectiveness is also similar.
Women taking endometriosis drugs need to watch for problems such as difficulty breathing or chest or leg pain, which may indicate a blood clot and should be reported to the doctor immediately. Other possible severe side effects include irregular heart rhythms. Frequent checkups are needed to monitor effects such as possible thinning of the bones. A patient should immediately report any new or worsened symptoms to the doctor. However, it's normal for endometriosis symptoms to temporarily worsen when a woman begins taking medicine.
Surgery
Sometimes medicine is not enough. Surgery may be needed to remove diseased tissue or to correct misaligned organs.
One method to remove diseased tissue combines laparoscopy with laser surgery. The laser is connected to the laparoscope and positioned so that its intense light beam is directed through the laparoscope onto the tissue to destroy it. The procedure usually is done without an overnight hospital stay and requires only about a week's recovery time at home.
Recurrence rates after treatment need further study, Ballweg says.
The monthly pain and heavy menstrual periods of chronic endometriosis can be frustrating and painful, and can lead to conceiving and infertility problems. But today, with prompt diagnosis and treatment, a young woman's life can often return to normal.
Dixie Farley is a staff writer for FDA Consumer.
For more information, contact:International Endometriosis Association 8585 N. 76th PlaceMilwaukee, WI 532231-800-992-3636
Publication No. (FDA) 93-1205
Thursday, May 22, 2008
Chronic Pelvic Pain: Diagnosis and Treatment
From the Reproductive Health Center: Endometriosis Corner
Trying to describe pain to someone is never easy. It's kind of like trying to describe the sound of a flute to someone who was born deaf. This can be particularly difficult when describing pelvic pain because it can be so hard to even know exactly where the pain is coming from. Thus, it's not surprising that a survey from the Endometriosis Association found a 10-year delay from the time women start experiencing symptoms until they receive a diagnosis.
That's a long time to live in pain.
Pelvic pain is inextricably linked to endometriosis--a medical condition in which tissue lining the uterus exists outside the uterus, where it grows and shrinks according to hormonal changes. An estimated 71 to 87 percent of women with chronic pelvic pain have endometriosis, which occurs in 7 to 10 percent of all women. And, contrary to what many health care professionals think, the condition can be quite common in adolescents and is often behind their chronic pelvic pain.
Read More
Trying to describe pain to someone is never easy. It's kind of like trying to describe the sound of a flute to someone who was born deaf. This can be particularly difficult when describing pelvic pain because it can be so hard to even know exactly where the pain is coming from. Thus, it's not surprising that a survey from the Endometriosis Association found a 10-year delay from the time women start experiencing symptoms until they receive a diagnosis.
That's a long time to live in pain.
Pelvic pain is inextricably linked to endometriosis--a medical condition in which tissue lining the uterus exists outside the uterus, where it grows and shrinks according to hormonal changes. An estimated 71 to 87 percent of women with chronic pelvic pain have endometriosis, which occurs in 7 to 10 percent of all women. And, contrary to what many health care professionals think, the condition can be quite common in adolescents and is often behind their chronic pelvic pain.
Read More
Tuesday, April 29, 2008
Article: Dioxin Class Action Cases against Monsanto in West Virginia
.....alleging dioxin from a former Monsanto Company plant contaminated residential properties and streams will be tried as class-action cases.
Continue to read this article...
Thanks to The Endometriosis Blog. Check them out!
http://theendometriosisblog.blogspot.com/
Continue to read this article...
Thanks to The Endometriosis Blog. Check them out!
http://theendometriosisblog.blogspot.com/
Friday, April 04, 2008
Stanford Surgeon's Procedures Raise Ethical and Legal Red Flags
Supporters say Camran Nezhat is a miracle worker -- critics call his operations bizarre and barbaric
William Carlsen, Sabin Russell, Chronicle Staff Writers
Wednesday, April 5,
With a white surgical mask dangling rakishly below his chin, Dr. Camran Nezhat looks every bit the part in his promotional video: medical pioneer, gifted surgeon, millionaire inventor of operating room tools. The Stanford clinical professor, recruited from his lucrative Atlanta practice, is a rainmaker for the university's medical center and obstetrics and gynecology department. Since he arrived at Stanford in 1993, he has brought patients, prestige, and scores of surgeons to study at the Stanford Endoscopy Center, which he directs.
But along with his brother gynecologists, Drs. Farr and Ceana Nezhat, he has also brought trouble to this elite enclave of high-tech medicine.
Trailing him to Stanford are allegations of reckless and unethical medical conduct. Critics accuse the Nezhats of performing a bizarre and dangerous medical experiment on the rectums of vulnerable female patients and of falsifying data reported in medical journal articles.
In the past five years, 20 doctors and surgeons across the country have signed statements of serious concern about the Nezhats' surgeries and published research and have called for an investigation.
''In my experience in the fields of law and medicine, I can't imagine a group of men who have crossed the line in more ways in the field of bioethics than the Nezhats,'' said Andrea Scott, a Los Angeles attorney and bioethicist.
And if the allegations against the Nezhats are true, soon top Stanford administrators may face troubling questions about the extent to which they heeded repeated warnings about the Nezhats and investigated the charges against them.
While the American College of Gynecology's code of ethics requires members to report questionable medical practices, a top Stanford official threatened at least one doctor with a lawsuit if he continued to criticize the Nezhats.
''There are serious, serious problems going on at Stanford,'' said Dr. Tom Margolis, a former Stanford Medical School professor who has signed a sworn affidavit charging the Nezhats with misconduct. ''Certain people are covering this up because there is a hell of a lot of money going to Stanford because of the Nezhats.''
The Nezhat brothers have declined to be interviewed. Through their Atlanta attorneys, they deny any wrongdoing and question the motives of their accusers, citing professional rivalry and economic competition. Stanford officials say they have thoroughly investigated and rejected allegations of scientific fraud.
Camran Nezhat is embraced by a large cadre of supporters, including Stanford colleagues and patients, who admire him personally and are awestruck by his abilities in the operating room.
''People like (Nezhat) are a rarity,'' said Salinas gynecologist Dr. Rene Charles. ''I'd compare him to Michelangelo, in terms of his surgical skills.''
In a letter of support sent to The Chronicle, 39 Stanford nurses and other health-care staff members describe Nezhat as a worker of ''miracles'' who takes cases ''others have given up on.''
Yet doubts about the Nezhats date back well into the 1980s, when Camran emerged in Georgia as a pioneer in the nascent art of laparoscopic surgery.
And they have been rekindled by recent developments in an astounding malpractice case that has been languishing in Atlanta courts for six years.
That case could determine once and for all whether the Nezhats are the pioneering surgeons they claim to be or whether they catapulted their careers to Stanford on the basis of a dangerous and grotesque medical fraud.
BUILDING A PRACTICE, 1988
Camran Nezhat and his brothers grew up in prerevolutionary Iran, where each attended medical school. Camran emigrated to the United States in 1974 and completed his obstetrics and gynecology residency at the State University of New York at Buffalo.
In 1978, he received a two-year reproductive endocrinology fellowship at Medical College of Georgia in Augusta. Farr and Ceana followed their older brother to Augusta and eventually joined Camran's growing practice in Atlanta.
During the 1980s, while practicing at Atlanta's Northside Hospital, the Nezhats began to develop a reputation for their skills in laparoscopy, a type of surgery in which laser scalpels, miniature cameras and long-stemmed instruments are worked inside the body through dime-sized incisions.
They published scores of articles in medical journals, claiming a remarkable series of ''surgical firsts.'' They also developed a number of ingenious instruments for the laparoscopic operating room. A company they co-founded, American Hydro-Surgical Instruments Inc., eventually sold for $40 million.
Their specialty was treating endometriosis, a painful ailment afflicting an estimated 5 million American women. It is caused when cells that make up the lining of the uterus migrate and bind to other parts of the abdominal cavity, swelling with the monthly menstrual cycle, sometimes causing debilitating pain. The condition is often linked to infertility.
Northside Hospital began promoting the Nezhats, hiring a public relations firm to spread the word about the doctors and their accomplishments. Camran was featured in Newsweek and the Chicago Tribune, and on MSNBC, CNN, ABC's ''20/20'' and elsewhere.
The brothers garnered a reputation as some of the world's foremost innovators of laparoscopic surgery, attracting cash-paying patients from around the globe.
THE MULLEN CASE, 1991
Suffering from endometriosis, 28-year-old Stacey Mullen flew from Southern California to Atlanta's Northside Hospital in 1988 to be operated on by Camran Nezhat. The surgery was quick, the pain was gone, and Mullen was elated as she walked out of the hospital the next day.
''I was ready to name my firstborn after Camran Nezhat,'' she said.
But, as often happens, the endometriosis and the pain returned. And in December 1991, Mullen flew back to Atlanta for what she thought would be another ''quick little surgery.''
The surgery, however, was neither little nor quick.
Camran and his brother Farr, with colorectal surgeon Dr. Earl Pennington assisting, spent hours using laparoscopic techniques to cut Mullen's colon and rectum free of nerves, blood vessels and connecting tissue. Her ''mobilized'' rectum was pulled inside out through her anus, and suspected endometrial tissue was removed. Her patched-up rectum was then pushed back inside.
Then the complications began.
Hours after surgery, part of her colon dropped out of her body as she sat on the toilet. For months, she suffered from extreme constipation. Sometimes she burped up her own feces.
Mullen never regained normal use of her bowel. Eventually, she received a colostomy and must insert a tube into an opening in her side to go the bathroom.
In December 1993, after nearly two years of continuing pain, she filed a malpractice suit against the Nezhats. ''Those bastards ruined my life,'' she said.
THREE ARTICLES, 1993
Shortly after taking Mullen's case, attorney James Neal discovered two medical journal articles that the Nezhats and Pennington had published after Mullen's operation.
The first appeared in Fertility & Sterility in May 1992, describing a single case using the new pull-through procedure for treating rectal endometriosis. ''As with all new procedures,'' the article said, ''there are no data to establish its safety.''
The second was published in the September 1992 issue of Surgical Laparoscopy & Endoscopy. It detailed a series of 16 rectal surgeries, similar to Mullen's, performed in late 1991 and early 1992 - the period during which her surgery took place.
Yet Mullen's case - and her complications - were not mentioned.
The article listed only a single complication: The doctors had to perform traditional open abdominal surgery in order to complete the suturing of one patient's bowel.
''This procedure has been performed safely in this initial series,'' the Nezhats wrote, and they claimed fewer problems than would be expected with regular open abdominal surgery.
The Nezhats aggressively publicized the ''success'' of the new procedure. It was touted by Ethicon Inc., the Johnson & Johnson subsidiary that made the instruments the Nezhats had used. ''For the estimated 185,000 women who suffer from endometriosis of the rectum, this new advance provides them with relief from the digestive symptoms,'' the company said.
At a 1991 American Fertility Society meeting in Orlando, and a 1992 convention of the American College of Obstetricians and Gynecologists in Las Vegas, Ethicon promoted their instruments and the Nezhats, even including a video of the surgery.
But skepticism about the Nezhats and their procedure was beginning to grow. The lack of complications did not make sense for such radical bowel surgery, doctors said. Some surgeons who viewed the promotional video were puzzled: They could not see evidence of endometriosis.
Stories began circulating in the surgical community around Atlanta's Northside Hospital. The medical journal articles said the average operating time for the surgeries was three hours, but during the time of the study, the Nezhat operating room had been burning lights deep into the Georgia night.
Then Neal discovered a third journal publication, written by one of Nezhat's Atlanta colleagues and published more than a year after Mullen's operation.
The article in Surgical Endoscopy described a ''pilot'' study testing the same procedure on pigs in order to assess its safety on humans.
''Some damage to the sphincter might occur,'' the authors wrote, but the long-term effects were unknown: The pigs were ''sacrificed'' before they awoke from anesthesia.
Neal and Mullen were stunned: Not only had the Nezhats omitted Mullen's case from their series - and in doing so did not report her complications - they apparently had tried out the new procedure on her and other women before it was tested on pigs.
Nezhat attorney David Walbert said the pig study ''had nothing whatever to do with the safety and efficacy'' of the human surgery described in the medical journals. The purpose of the pig experiment, he said, was to determine whether the procedure was suitable for treating cancer.
'BARBARIC,' 1993
When Neal began contacting medical experts about Mullen's surgery, many sent him letters and affidavits calling the operation radical and experimental; they characterized it as ''bizarre'' and ''barbaric.'' It resembled a cancer surgery that had been discredited years before, after complication rates as high as 50 percent were reported.
The surgery had not been vetted before a Northside Hospital Institutional Review Board, the usual requirement for an experimental procedure.
''Normally you go before an IRB, come up with scientific background, present a plan, torturous documentation, nine pages of informed consent, and you cannot charge for it,'' said Ohio general surgeon Dr. Francis Barnes.
Mullen and her insurance company, however, were billed $9,900 for the rectal surgery. She eventually ran up more than $1 million in additional medical expenses as a result of the operation, according to Neal.
Neal also learned that Mullen - and possibly four other women whose cases were included in the Nezhats' articles - had signed an unusual document, recently created by the Georgia legislature. It was called a ''waiver of informed consent,'' and it set aside a patient's right to detailed information about a surgery.
''This is incomprehensibly unethical,'' said Arthur Caplan, director of the University of Pennsylvania Center for Bioethics and one of the nation's foremost medical ethicists. ''You can no more sign away your right to informed consent than you can voluntarily sell yourself to slavery.''
''I never knew I was signing such a document,'' Mullen said. ''I thought it was a regular consent form.''
Yet the most disturbing discovery was made in Mullen's own medical records. In his operative notes, Camran Nezhat wrote: ''There was evidence of severe endometriosis of the rectum.''
But Mullen's pathology lab report disclosed that there had been no endometriosis on the wall of her rectum at all - just a few cells in the adjoining fat. The surgery had not been necessary in the first place.
16 MEDICAL RECORDS
Neal went to court and demanded to see the medical records of the 16 other patients the Nezhats had operated on in Georgia, convinced they would show complications, more waivers of informed consent, and surgical data different from what was reported in the Nezhat articles.
But the Nezhat legal team refused to turn them over, citing privacy concerns of other patients - at least 10 of whom signed affidavits opposing any release.
Mullen was given the waiver form by mistake, they explained, and she was told about the procedure's risks. Medical experts for the Nezhats also insist that the rectal surgery was not experimental, so no Institutional Review Board process was required.
''In my opinion, the surgery performed on Mary (Stacey) Mullen was a necessary procedure and would not require any special consent form for experimental surgery,'' said Dr. Robert R. Franklin, a clinical professor in the department of obstetrics and gynecology at Houston's Baylor College of Medicine.
The Nezhat lawyers also argue that Mullen's rectal surgery did not cause her bowel problems. ''She reported constipation before the procedure,'' said Walbert.
THE FIRST WARNING, 1993
In the early 1990s, Stanford Medical School's department of obstetrics and gynecology was in trouble. Despite the school's lofty reputation, the department was not fully accredited.
The Chicago-based Accreditation Council for Graduate Medical Education demanded more ''surgical volume'' before it would upgrade the program's ''provisional'' status.
Yet when Dr. Nick Spirtos heard that Stanford was recruiting the Nezhats, he could not believe it.
Spirtos is a Palo Alto gynecological oncologist with an august reputation of his own. Like the Nezhats, he is a clinical professor, which means he serves on the school's voluntary teaching faculty with surgical privileges at the medical center. He also holds the elected post of deputy chief of the obstetrics and gynecology department.
During the past nine years, he has become a leading critic of the Nezhats and their Stanford defenders.
''I think everything they've written is fraudulent,'' said Spirtos, whose office is just one floor below the Nezhats' in an upscale medical office building near Stanford. ''I don't think they should be allowed to practice medicine.''
Spirtos had traveled with colleagues to a gynecology convention in Florida to see the 1991 presentation by Camran and Farr Nezhat sponsored by Ethicon. The program included videos of two new Nezhat operations, one of them showing the rectal procedure that would be performed two months later on Mullen.
''We couldn't believe what we saw,'' Spirtos said, noting that there was no evidence of endometriosis. ''The surgeries didn't make any sense.''
But before they could quiz the Nezhats about their presentation, Spirtos recalled, the Nezhats left the podium, refusing to answer questions.
Two years later, after studying their journal articles, he warned university administrators not to bring them to Stanford. Spirtos argued that the Nezhats' published data were simply too good to be true.
But Spirtos said his advice was ignored.
''It was a perfect marriage,'' he said. ''The Nezhats had all the dough in the world but no title. And Stanford needed desperately to have surgical volume to legitimize their (obstetrics and gynecology) department.''
NEW TROUBLE, 1993
Within two years of the Nezhats' arrival in Palo Alto, Camran became director of the new Stanford Endoscopy Center for Training and Technology. And Ethicon, which had retained Nezhat as a surgical investigator, agreed to provide a $125,000 annual grant to the center.
Quickly, the Nezhats began pairing up with surgeons outside their immediate discipline - including specialists in cancer, heart and brain surgery - with the goal of expanding the use of minimally invasive surgical techniques.
The practice troubled Spirtos, and when he learned that Camran Nezhat intended to operate on a patient of one of Spirtos' medical partners, he wrote in protest to Dr. Mary Lake Polan, the chief of the obstetrics and gynecology department.
The patient was a 74-year-old woman who had undergone extensive surgery for the removal of pelvic cancer, and Spirtos told Polan that the patient's cancer had spread so extensively that laparoscopic surgery would be useless.
''Certainly, (Nezhat) has no experience in this area (treating cancer), and it seems to me serious patient care issues are being placed on the back burner in your headlong rush to promote the Nezhats,'' he said in a 1993 letter to Polan.
Despite Spirtos' protests, Nezhat and Stanford cancer surgeon Dr. Nelson Teng went ahead with the operation.
The patient was on the operating table for seven hours and was hospitalized for seven days afterward. Her bladder and bowel were punctured during the operation, Spirtos said, and the doctors could not remove all the cancer. In his report to the university's ''quality assurance'' review committee, Spirtos charged that Nezhat, credentialed as a gynecologist, was performing cancer surgeries, a specialty that requires years of extra formal training. He also laid out four other Nezhat cancer cases for the quality assurance review committee.
''No other hospital would allow a gynecologist to perform (cancer) surgeries,'' said Spirtos.
But his hope for a quick review of the five cases soon faded. ''Stanford sat on those cases for years,'' he said.
NEZHAT'S AFFIDAVIT, 1994
Meanwhile, Mullen and her attorney continued to press for the release of the files on the 16 other women who had undergone the rectal procedure. And the Nezhats continued to refuse.
In a sworn 1994 affidavit, Camran Nezhat declared it would disrupt his practice for months if he were ordered to produce records demanded by Mullen's legal team.
He described a filing system with 20,000 patients, each listed only alphabetically, with no index, no computer database and no cross-referencing by type of treatment, surgery performed, or journal publication.
''I would . . . have to manually review every single patient record . . . to determine whether the record referenced a patient whose procedure was the subject of a journal article,'' he testified.
The affidavit shocked Nezhat's critics, who say it has cast a pall on the validity of the Nezhats' research ever since.
''I've been doing this kind of research for 25 years. There is a substantial problem if you cannot link patient records to publications,'' said Dr. David Grimes, former chief of obstetrics and gynecology at San Francisco General Hospital, who briefly served as a paid expert to Mullen's legal team.
How, asks Grimes, can the Nezhats publish extensive studies based on old charts and old data involving hundreds of patients over many years if those patients' files are not indexed or cross-referenced?
Grimes was not the first doctor to question the Nezhats' research. Long before they publicized their controversial bowel surgery, competitors and collaborators alike were skeptical of the brothers' claims of surgical firsts and problem-free procedures. In 1987, Dr. Harry Reich, a world-renowned laparoscopic surgeon at New York's Columbia-Presbyterian Medical Center, agreed to collaborate with Camran Nezhat on a surgical study of 105 tubal pregnancies.
But Reich was bothered by Nezhat's repeated failure to share his data on 40 patients to be included in their article in the Journal of Reproductive Medicine.
''So we had to delete the data from the paper,'' Reich recalled.
The Nezhats' lawyers say Reich never requested any data that were not provided.
In 1990, a Nezhat report in the journal Obstetrics and Gynecology also raised eyebrows. The Nezhats stated they had performed 4,000 laparoscopic surgeries without injuring a ureter, the tube connecting the kidney and bladder.
Their claim drew a sarcastic response from three Yale University doctors: ''The authors are to be congratulated. . . . Either these surgeons had other complications, perhaps as serious, or they possess an unbelievably high level of skill and judgment.''
Other articles in which the Nezhats claim to have reviewed thousands of old cases include:
-- A 1995 textbook article describing 214 complications among 6,949 cases in Atlanta and Stanford from 1982 to 1993.
-- A 1996 medical journal report of severe urinary tract endometriosis in 28 women among 2,226 treated for endometriosis from 1989 to 1994.
-- A 1997 study examining 5,300 surgeries dating back to 1988, counting up 11 hernias caused by insertion of the laparoscope.
Atlanta attorney Walbert scoffs at accusations of medical fraud. ''Many, many surgeons'' have conducted research with the Nezhats, he said. ''Those who have any knowledge have never claimed there was anything 'bogus' about any of the reports.''
Dr. Sally Tazuke, a Stanford reproductive endocrinologist who has worked with Camran Nezhat frequently, said his reported complications are low because he is exceptionally good at what he does - even while taking on the riskiest cases. ''If I were a patient, I would sign up with him. I'd send any family member,'' she said.
Skeptics say the stakes are high. Dr. Thomas Lyons, an Atlanta gynecological surgeon who believes the Nezhats have published journal articles with phony data, said medical fraud can lead unsuspecting doctors to hurt their patients.
''This is as dangerous a situation as you can run into in medicine, because people may be making medical decisions based on something that doesn't exist,'' he said.
If someone ever questioned the veracity of his own data, Lyons said, ''The first thing I would do is throw that data right in their face. . . . The best defense in the world is the truth.''
NEAL'S LETTER, 1995
In January 1995, Mullen's attorney, James Neal, wrote to Stanford, alerting the university to the allegations his legal team was making against the Nezhats. As a former hospital counsel himself, he said he thought they would appreciate a copy of the Mullen lawsuit.
''I feel that your institution should have the opportunity to evaluate these matters . . . given your understandable and overriding concern for the patients within your institution,'' Neal wrote.
But Stanford took no action.
Instead, Margaret Eaton, a university lawyer, forwarded the letter to Nezhat's attorney in Atlanta, with a note saying that ''we do not intend to respond to this letter, nor are further communications from Mr. Neal welcome.''
In June 1995 the Accreditation Council for Graduate Medical Education approved full accreditation to Stanford.
ALLEGATIONS, 1996
A year later, Neal sent Stanford a thick package of documents, laying out in more detail the charges against the Nezhats and asking Stanford to investigate.
Dr. Richard Popp, Stanford's senior associate dean for academic affairs, said Neal provided a ''massive amount'' of what he called ''disorganized'' information.
Popp finally opened an inquiry into the charge of scientific misconduct. But university officials contend that by that time, some of the allegations, including Neal's claim of medical journal fraud, had been thrown out by the Georgia courts.
Neal, who freely admits that he has become obsessed with exposing the Nezhats, was running up a list of legal setbacks. In his dogged pursuit of the Nezhats, he was building a reputation as a crank.
He was disqualified from the malpractice case by a Georgia judge in 1995 for ''unethical behavior'' and could no longer represent Mullen. After a federal judge last year tossed out his attempt, on behalf of another client charging malpractice, to use racketeering charges against the Nezhats, Neal was charged with contempt of court. The judge also assessed $384,000 in ''sanctions'' against the plaintiff and her remaining attorneys. The sanctions are on appeal.
Neal denies the unethical conduct allegation, and the contempt of court charge was recently dropped. The only thing he is guilty of, he says, is aggressively representing his clients against institutions willing to look the other way.
''These guys are bad doctors, some have even said evil, and they have to be stopped,'' he said.
WITNESS, 1996
Shortly after Dr. Tom Margolis joined Stanford as an assistant professor and chief of pelvic surgery, Farr Nezhat invited the newcomer to watch him perform a complex laparoscopic procedure.
During the operation, Nezhat cut the patient's ureter. Margolis, who had also served as director of urogynecologic/pelvic surgery at Northwestern University Medical School, assumed it was an accident, a known but unwelcome complication of the difficult surgical technique. He stepped in to assist Nezhat in repairing it.
But a short time later Margolis learned that, in a post-operative review session and the operative report, Nezhat described the cut as deliberate. He said he sliced the ureter to remove endometriosis that could have blocked urine flow.
Margolis was outraged. He said that he saw no endometriosis on the ureter and that the pathology report proved it.
''It was clear that Dr. Nezhat was performing an unnecessary procedure,'' he said in a sworn affidavit.
THE POLAN MEETING, 1996
More than two years passed before Stanford's quality assurance committee took up the review of the five cancer cases in which Spirtos had alleged improper surgeries by Camran Nezhat.
Just before the review committee was finally set to meet, Dr. Mary Lake Polan, chairman of obstetrics and gynecology, dropped by Margolis' office. He was one of the physicians reviewing the cases.
''We need to make sure that Nezhat is cleared on all these (cancer) cases,'' she told him, according to his affidavit.
Ultimately Margolis - and the other members of the quality assurance committee - voted in favor of Nezhat on all charges.
Polan said Margolis' allegations are false.
''I adamantly deny the statements attributed to me and deny there has been any pressure to exonerate any physician during the quality of care committee process," she declared in a written response to The Chronicle.
Margolis' decision to vote to exonerate Nezhat would haunt him for more than a year, until finally he had to act.
THE SHUER LETTER, 1998
In April 1998, Margolis met with Dr. Lawrence Shuer, chief of staff of the medical center. He told Shuer about the cut ureter incident and the pressure Polan had allegedly exerted on him.
''He (Shuer) acutely and abruptly ended our conversation, and I was excused from his office,'' Margolis said.
More than a year later, when Shuer learned Margolis was still criticizing the Nezhats and Stanford, he sent a written warning:
''Rest assured that Stanford Hospital and Clinics intends to pursue its full legal remedies if these defamatory and libelous statement do not cease,'' Shuer wrote.
Furious, Margolis, who had left Stanford to practice with Spirtos at the Women's Cancer Center in Palo Alto and Los Gatos, wrote back, saying that Shuer's job as chief of staff was ''patient protection not doctor protection.''
''The data which (the Nezhats) have published, including the rectal eversion procedure, is fraudulent, yet their publications are being accepted as standards in the surgical community. Stanford, by not auditing this clinical data, has ignored the concerns of scores of surgeons,'' Margolis wrote.
STANFORD'S DUTY, 2000
Defenders of the Nezhats at Stanford dismiss both Spirtos and Margolis as jealous competitors. But other medical experts say Stanford should have demanded a review of the 16 cases and has shirked its responsibility to verify the Nezhats' research claims.
''Stanford has a duty to review this,'' said Dr. Warren Grundfest, chairman of Biomedical Engineering at UCLA and an expert in new medical technologies. ''Serious allegations have been made by credible people, but Stanford has played like an ostrich with its head in the sand.''
But Stanford officials contend they are not obligated to review the 16 patient records because the rectal surgeries were performed in Georgia before the Nezhats came to the West Coast. Shuer said the procedure in question has never been performed at Stanford.
It was appropriate for the Nezhats to leave Mullen's case out of the medical journal, according to Stanford, because she was ultimately found not to have rectal endometriosis like the other patients.
Stanford reviewers have never asked the Nezhats or Northside Hospital for the records to verify the accuracy of the other 16 cases. ''We have no right to the records and do not want to violate patient privacy,'' said Stanford's lawyer Debra Zumwalt.
The university also never interviewed Mullen or the 20 doctors who have expressed concern over the Nezhats' research.
According to Stanford, the appropriate institutions to investigate the Nezhats are Northside Hospital, the Georgia Medical Board and Mercer University, where the Nezhats were clinical professors at the time of the surgeries. ''Stanford will carefully review the conclusions of those investigations,'' said Popp.
But a spokesman for Mercer, a Macon, Ga., medical school founded in 1986, said the school has no investigation pending.
The Georgia Medical Board's investigation of the Nezhats is continuing. The board will not comment on its status.
Stanford attorney Zumwalt said Margolis' complaint to Shuer regarding the cut ureter incident was never put in writing. Shuer said he asked Margolis for more information, and none was provided, but the case has now been identified and is being investigated by the quality assurance committee.
The university said the Nezhats have been cleared of allegations that they operated outside their specialty. Officials would not comment, however, on any details of the five quality assurance cases because they are confidential.
''One thing I can point out,'' said Zumwalt, ''is that doctors and patients and their families can reasonably disagree as to how aggressive to be in treating terminal diseases.''
GEORGIA COURTROOM, 2000
Mullen has refused to engage in monetary settlement talks with the Nezhats and promises to continue her suit until the records of the 16 other women are made public.
''My life has been changed in a very horrible and profound way by the experiment (that) Camran Nezhat has conducted upon me without my knowledge,'' Mullen said in an affidavit. ''I despair that other women will be injured by well-meaning surgeons who believe Camran Nezhat's article that there were no complications from this new surgery.''
In November, after a battle spanning six years - and six judges - Superior Court Judge Melvin Westmoreland in Atlanta ordered a confidential release of the records to Mullen's lawyers, and in January, the Nezhats and Northside Hospital turned them over.
While the records remain sealed, medical experts hired by Mullen's legal team to review the documents have written Judge Westmoreland expressing their concern about what the records contain, and urging that they be unsealed, in the public interest. ..
William Carlsen can be reached at wcarlsen@sfgate.com. Sabin Russell can be reached at sabin@sfgate.com.
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2000/04/05/MN29STA.DTL
William Carlsen, Sabin Russell, Chronicle Staff Writers
Wednesday, April 5,
With a white surgical mask dangling rakishly below his chin, Dr. Camran Nezhat looks every bit the part in his promotional video: medical pioneer, gifted surgeon, millionaire inventor of operating room tools. The Stanford clinical professor, recruited from his lucrative Atlanta practice, is a rainmaker for the university's medical center and obstetrics and gynecology department. Since he arrived at Stanford in 1993, he has brought patients, prestige, and scores of surgeons to study at the Stanford Endoscopy Center, which he directs.
But along with his brother gynecologists, Drs. Farr and Ceana Nezhat, he has also brought trouble to this elite enclave of high-tech medicine.
Trailing him to Stanford are allegations of reckless and unethical medical conduct. Critics accuse the Nezhats of performing a bizarre and dangerous medical experiment on the rectums of vulnerable female patients and of falsifying data reported in medical journal articles.
In the past five years, 20 doctors and surgeons across the country have signed statements of serious concern about the Nezhats' surgeries and published research and have called for an investigation.
''In my experience in the fields of law and medicine, I can't imagine a group of men who have crossed the line in more ways in the field of bioethics than the Nezhats,'' said Andrea Scott, a Los Angeles attorney and bioethicist.
And if the allegations against the Nezhats are true, soon top Stanford administrators may face troubling questions about the extent to which they heeded repeated warnings about the Nezhats and investigated the charges against them.
While the American College of Gynecology's code of ethics requires members to report questionable medical practices, a top Stanford official threatened at least one doctor with a lawsuit if he continued to criticize the Nezhats.
''There are serious, serious problems going on at Stanford,'' said Dr. Tom Margolis, a former Stanford Medical School professor who has signed a sworn affidavit charging the Nezhats with misconduct. ''Certain people are covering this up because there is a hell of a lot of money going to Stanford because of the Nezhats.''
The Nezhat brothers have declined to be interviewed. Through their Atlanta attorneys, they deny any wrongdoing and question the motives of their accusers, citing professional rivalry and economic competition. Stanford officials say they have thoroughly investigated and rejected allegations of scientific fraud.
Camran Nezhat is embraced by a large cadre of supporters, including Stanford colleagues and patients, who admire him personally and are awestruck by his abilities in the operating room.
''People like (Nezhat) are a rarity,'' said Salinas gynecologist Dr. Rene Charles. ''I'd compare him to Michelangelo, in terms of his surgical skills.''
In a letter of support sent to The Chronicle, 39 Stanford nurses and other health-care staff members describe Nezhat as a worker of ''miracles'' who takes cases ''others have given up on.''
Yet doubts about the Nezhats date back well into the 1980s, when Camran emerged in Georgia as a pioneer in the nascent art of laparoscopic surgery.
And they have been rekindled by recent developments in an astounding malpractice case that has been languishing in Atlanta courts for six years.
That case could determine once and for all whether the Nezhats are the pioneering surgeons they claim to be or whether they catapulted their careers to Stanford on the basis of a dangerous and grotesque medical fraud.
BUILDING A PRACTICE, 1988
Camran Nezhat and his brothers grew up in prerevolutionary Iran, where each attended medical school. Camran emigrated to the United States in 1974 and completed his obstetrics and gynecology residency at the State University of New York at Buffalo.
In 1978, he received a two-year reproductive endocrinology fellowship at Medical College of Georgia in Augusta. Farr and Ceana followed their older brother to Augusta and eventually joined Camran's growing practice in Atlanta.
During the 1980s, while practicing at Atlanta's Northside Hospital, the Nezhats began to develop a reputation for their skills in laparoscopy, a type of surgery in which laser scalpels, miniature cameras and long-stemmed instruments are worked inside the body through dime-sized incisions.
They published scores of articles in medical journals, claiming a remarkable series of ''surgical firsts.'' They also developed a number of ingenious instruments for the laparoscopic operating room. A company they co-founded, American Hydro-Surgical Instruments Inc., eventually sold for $40 million.
Their specialty was treating endometriosis, a painful ailment afflicting an estimated 5 million American women. It is caused when cells that make up the lining of the uterus migrate and bind to other parts of the abdominal cavity, swelling with the monthly menstrual cycle, sometimes causing debilitating pain. The condition is often linked to infertility.
Northside Hospital began promoting the Nezhats, hiring a public relations firm to spread the word about the doctors and their accomplishments. Camran was featured in Newsweek and the Chicago Tribune, and on MSNBC, CNN, ABC's ''20/20'' and elsewhere.
The brothers garnered a reputation as some of the world's foremost innovators of laparoscopic surgery, attracting cash-paying patients from around the globe.
THE MULLEN CASE, 1991
Suffering from endometriosis, 28-year-old Stacey Mullen flew from Southern California to Atlanta's Northside Hospital in 1988 to be operated on by Camran Nezhat. The surgery was quick, the pain was gone, and Mullen was elated as she walked out of the hospital the next day.
''I was ready to name my firstborn after Camran Nezhat,'' she said.
But, as often happens, the endometriosis and the pain returned. And in December 1991, Mullen flew back to Atlanta for what she thought would be another ''quick little surgery.''
The surgery, however, was neither little nor quick.
Camran and his brother Farr, with colorectal surgeon Dr. Earl Pennington assisting, spent hours using laparoscopic techniques to cut Mullen's colon and rectum free of nerves, blood vessels and connecting tissue. Her ''mobilized'' rectum was pulled inside out through her anus, and suspected endometrial tissue was removed. Her patched-up rectum was then pushed back inside.
Then the complications began.
Hours after surgery, part of her colon dropped out of her body as she sat on the toilet. For months, she suffered from extreme constipation. Sometimes she burped up her own feces.
Mullen never regained normal use of her bowel. Eventually, she received a colostomy and must insert a tube into an opening in her side to go the bathroom.
In December 1993, after nearly two years of continuing pain, she filed a malpractice suit against the Nezhats. ''Those bastards ruined my life,'' she said.
THREE ARTICLES, 1993
Shortly after taking Mullen's case, attorney James Neal discovered two medical journal articles that the Nezhats and Pennington had published after Mullen's operation.
The first appeared in Fertility & Sterility in May 1992, describing a single case using the new pull-through procedure for treating rectal endometriosis. ''As with all new procedures,'' the article said, ''there are no data to establish its safety.''
The second was published in the September 1992 issue of Surgical Laparoscopy & Endoscopy. It detailed a series of 16 rectal surgeries, similar to Mullen's, performed in late 1991 and early 1992 - the period during which her surgery took place.
Yet Mullen's case - and her complications - were not mentioned.
The article listed only a single complication: The doctors had to perform traditional open abdominal surgery in order to complete the suturing of one patient's bowel.
''This procedure has been performed safely in this initial series,'' the Nezhats wrote, and they claimed fewer problems than would be expected with regular open abdominal surgery.
The Nezhats aggressively publicized the ''success'' of the new procedure. It was touted by Ethicon Inc., the Johnson & Johnson subsidiary that made the instruments the Nezhats had used. ''For the estimated 185,000 women who suffer from endometriosis of the rectum, this new advance provides them with relief from the digestive symptoms,'' the company said.
At a 1991 American Fertility Society meeting in Orlando, and a 1992 convention of the American College of Obstetricians and Gynecologists in Las Vegas, Ethicon promoted their instruments and the Nezhats, even including a video of the surgery.
But skepticism about the Nezhats and their procedure was beginning to grow. The lack of complications did not make sense for such radical bowel surgery, doctors said. Some surgeons who viewed the promotional video were puzzled: They could not see evidence of endometriosis.
Stories began circulating in the surgical community around Atlanta's Northside Hospital. The medical journal articles said the average operating time for the surgeries was three hours, but during the time of the study, the Nezhat operating room had been burning lights deep into the Georgia night.
Then Neal discovered a third journal publication, written by one of Nezhat's Atlanta colleagues and published more than a year after Mullen's operation.
The article in Surgical Endoscopy described a ''pilot'' study testing the same procedure on pigs in order to assess its safety on humans.
''Some damage to the sphincter might occur,'' the authors wrote, but the long-term effects were unknown: The pigs were ''sacrificed'' before they awoke from anesthesia.
Neal and Mullen were stunned: Not only had the Nezhats omitted Mullen's case from their series - and in doing so did not report her complications - they apparently had tried out the new procedure on her and other women before it was tested on pigs.
Nezhat attorney David Walbert said the pig study ''had nothing whatever to do with the safety and efficacy'' of the human surgery described in the medical journals. The purpose of the pig experiment, he said, was to determine whether the procedure was suitable for treating cancer.
'BARBARIC,' 1993
When Neal began contacting medical experts about Mullen's surgery, many sent him letters and affidavits calling the operation radical and experimental; they characterized it as ''bizarre'' and ''barbaric.'' It resembled a cancer surgery that had been discredited years before, after complication rates as high as 50 percent were reported.
The surgery had not been vetted before a Northside Hospital Institutional Review Board, the usual requirement for an experimental procedure.
''Normally you go before an IRB, come up with scientific background, present a plan, torturous documentation, nine pages of informed consent, and you cannot charge for it,'' said Ohio general surgeon Dr. Francis Barnes.
Mullen and her insurance company, however, were billed $9,900 for the rectal surgery. She eventually ran up more than $1 million in additional medical expenses as a result of the operation, according to Neal.
Neal also learned that Mullen - and possibly four other women whose cases were included in the Nezhats' articles - had signed an unusual document, recently created by the Georgia legislature. It was called a ''waiver of informed consent,'' and it set aside a patient's right to detailed information about a surgery.
''This is incomprehensibly unethical,'' said Arthur Caplan, director of the University of Pennsylvania Center for Bioethics and one of the nation's foremost medical ethicists. ''You can no more sign away your right to informed consent than you can voluntarily sell yourself to slavery.''
''I never knew I was signing such a document,'' Mullen said. ''I thought it was a regular consent form.''
Yet the most disturbing discovery was made in Mullen's own medical records. In his operative notes, Camran Nezhat wrote: ''There was evidence of severe endometriosis of the rectum.''
But Mullen's pathology lab report disclosed that there had been no endometriosis on the wall of her rectum at all - just a few cells in the adjoining fat. The surgery had not been necessary in the first place.
16 MEDICAL RECORDS
Neal went to court and demanded to see the medical records of the 16 other patients the Nezhats had operated on in Georgia, convinced they would show complications, more waivers of informed consent, and surgical data different from what was reported in the Nezhat articles.
But the Nezhat legal team refused to turn them over, citing privacy concerns of other patients - at least 10 of whom signed affidavits opposing any release.
Mullen was given the waiver form by mistake, they explained, and she was told about the procedure's risks. Medical experts for the Nezhats also insist that the rectal surgery was not experimental, so no Institutional Review Board process was required.
''In my opinion, the surgery performed on Mary (Stacey) Mullen was a necessary procedure and would not require any special consent form for experimental surgery,'' said Dr. Robert R. Franklin, a clinical professor in the department of obstetrics and gynecology at Houston's Baylor College of Medicine.
The Nezhat lawyers also argue that Mullen's rectal surgery did not cause her bowel problems. ''She reported constipation before the procedure,'' said Walbert.
THE FIRST WARNING, 1993
In the early 1990s, Stanford Medical School's department of obstetrics and gynecology was in trouble. Despite the school's lofty reputation, the department was not fully accredited.
The Chicago-based Accreditation Council for Graduate Medical Education demanded more ''surgical volume'' before it would upgrade the program's ''provisional'' status.
Yet when Dr. Nick Spirtos heard that Stanford was recruiting the Nezhats, he could not believe it.
Spirtos is a Palo Alto gynecological oncologist with an august reputation of his own. Like the Nezhats, he is a clinical professor, which means he serves on the school's voluntary teaching faculty with surgical privileges at the medical center. He also holds the elected post of deputy chief of the obstetrics and gynecology department.
During the past nine years, he has become a leading critic of the Nezhats and their Stanford defenders.
''I think everything they've written is fraudulent,'' said Spirtos, whose office is just one floor below the Nezhats' in an upscale medical office building near Stanford. ''I don't think they should be allowed to practice medicine.''
Spirtos had traveled with colleagues to a gynecology convention in Florida to see the 1991 presentation by Camran and Farr Nezhat sponsored by Ethicon. The program included videos of two new Nezhat operations, one of them showing the rectal procedure that would be performed two months later on Mullen.
''We couldn't believe what we saw,'' Spirtos said, noting that there was no evidence of endometriosis. ''The surgeries didn't make any sense.''
But before they could quiz the Nezhats about their presentation, Spirtos recalled, the Nezhats left the podium, refusing to answer questions.
Two years later, after studying their journal articles, he warned university administrators not to bring them to Stanford. Spirtos argued that the Nezhats' published data were simply too good to be true.
But Spirtos said his advice was ignored.
''It was a perfect marriage,'' he said. ''The Nezhats had all the dough in the world but no title. And Stanford needed desperately to have surgical volume to legitimize their (obstetrics and gynecology) department.''
NEW TROUBLE, 1993
Within two years of the Nezhats' arrival in Palo Alto, Camran became director of the new Stanford Endoscopy Center for Training and Technology. And Ethicon, which had retained Nezhat as a surgical investigator, agreed to provide a $125,000 annual grant to the center.
Quickly, the Nezhats began pairing up with surgeons outside their immediate discipline - including specialists in cancer, heart and brain surgery - with the goal of expanding the use of minimally invasive surgical techniques.
The practice troubled Spirtos, and when he learned that Camran Nezhat intended to operate on a patient of one of Spirtos' medical partners, he wrote in protest to Dr. Mary Lake Polan, the chief of the obstetrics and gynecology department.
The patient was a 74-year-old woman who had undergone extensive surgery for the removal of pelvic cancer, and Spirtos told Polan that the patient's cancer had spread so extensively that laparoscopic surgery would be useless.
''Certainly, (Nezhat) has no experience in this area (treating cancer), and it seems to me serious patient care issues are being placed on the back burner in your headlong rush to promote the Nezhats,'' he said in a 1993 letter to Polan.
Despite Spirtos' protests, Nezhat and Stanford cancer surgeon Dr. Nelson Teng went ahead with the operation.
The patient was on the operating table for seven hours and was hospitalized for seven days afterward. Her bladder and bowel were punctured during the operation, Spirtos said, and the doctors could not remove all the cancer. In his report to the university's ''quality assurance'' review committee, Spirtos charged that Nezhat, credentialed as a gynecologist, was performing cancer surgeries, a specialty that requires years of extra formal training. He also laid out four other Nezhat cancer cases for the quality assurance review committee.
''No other hospital would allow a gynecologist to perform (cancer) surgeries,'' said Spirtos.
But his hope for a quick review of the five cases soon faded. ''Stanford sat on those cases for years,'' he said.
NEZHAT'S AFFIDAVIT, 1994
Meanwhile, Mullen and her attorney continued to press for the release of the files on the 16 other women who had undergone the rectal procedure. And the Nezhats continued to refuse.
In a sworn 1994 affidavit, Camran Nezhat declared it would disrupt his practice for months if he were ordered to produce records demanded by Mullen's legal team.
He described a filing system with 20,000 patients, each listed only alphabetically, with no index, no computer database and no cross-referencing by type of treatment, surgery performed, or journal publication.
''I would . . . have to manually review every single patient record . . . to determine whether the record referenced a patient whose procedure was the subject of a journal article,'' he testified.
The affidavit shocked Nezhat's critics, who say it has cast a pall on the validity of the Nezhats' research ever since.
''I've been doing this kind of research for 25 years. There is a substantial problem if you cannot link patient records to publications,'' said Dr. David Grimes, former chief of obstetrics and gynecology at San Francisco General Hospital, who briefly served as a paid expert to Mullen's legal team.
How, asks Grimes, can the Nezhats publish extensive studies based on old charts and old data involving hundreds of patients over many years if those patients' files are not indexed or cross-referenced?
Grimes was not the first doctor to question the Nezhats' research. Long before they publicized their controversial bowel surgery, competitors and collaborators alike were skeptical of the brothers' claims of surgical firsts and problem-free procedures. In 1987, Dr. Harry Reich, a world-renowned laparoscopic surgeon at New York's Columbia-Presbyterian Medical Center, agreed to collaborate with Camran Nezhat on a surgical study of 105 tubal pregnancies.
But Reich was bothered by Nezhat's repeated failure to share his data on 40 patients to be included in their article in the Journal of Reproductive Medicine.
''So we had to delete the data from the paper,'' Reich recalled.
The Nezhats' lawyers say Reich never requested any data that were not provided.
In 1990, a Nezhat report in the journal Obstetrics and Gynecology also raised eyebrows. The Nezhats stated they had performed 4,000 laparoscopic surgeries without injuring a ureter, the tube connecting the kidney and bladder.
Their claim drew a sarcastic response from three Yale University doctors: ''The authors are to be congratulated. . . . Either these surgeons had other complications, perhaps as serious, or they possess an unbelievably high level of skill and judgment.''
Other articles in which the Nezhats claim to have reviewed thousands of old cases include:
-- A 1995 textbook article describing 214 complications among 6,949 cases in Atlanta and Stanford from 1982 to 1993.
-- A 1996 medical journal report of severe urinary tract endometriosis in 28 women among 2,226 treated for endometriosis from 1989 to 1994.
-- A 1997 study examining 5,300 surgeries dating back to 1988, counting up 11 hernias caused by insertion of the laparoscope.
Atlanta attorney Walbert scoffs at accusations of medical fraud. ''Many, many surgeons'' have conducted research with the Nezhats, he said. ''Those who have any knowledge have never claimed there was anything 'bogus' about any of the reports.''
Dr. Sally Tazuke, a Stanford reproductive endocrinologist who has worked with Camran Nezhat frequently, said his reported complications are low because he is exceptionally good at what he does - even while taking on the riskiest cases. ''If I were a patient, I would sign up with him. I'd send any family member,'' she said.
Skeptics say the stakes are high. Dr. Thomas Lyons, an Atlanta gynecological surgeon who believes the Nezhats have published journal articles with phony data, said medical fraud can lead unsuspecting doctors to hurt their patients.
''This is as dangerous a situation as you can run into in medicine, because people may be making medical decisions based on something that doesn't exist,'' he said.
If someone ever questioned the veracity of his own data, Lyons said, ''The first thing I would do is throw that data right in their face. . . . The best defense in the world is the truth.''
NEAL'S LETTER, 1995
In January 1995, Mullen's attorney, James Neal, wrote to Stanford, alerting the university to the allegations his legal team was making against the Nezhats. As a former hospital counsel himself, he said he thought they would appreciate a copy of the Mullen lawsuit.
''I feel that your institution should have the opportunity to evaluate these matters . . . given your understandable and overriding concern for the patients within your institution,'' Neal wrote.
But Stanford took no action.
Instead, Margaret Eaton, a university lawyer, forwarded the letter to Nezhat's attorney in Atlanta, with a note saying that ''we do not intend to respond to this letter, nor are further communications from Mr. Neal welcome.''
In June 1995 the Accreditation Council for Graduate Medical Education approved full accreditation to Stanford.
ALLEGATIONS, 1996
A year later, Neal sent Stanford a thick package of documents, laying out in more detail the charges against the Nezhats and asking Stanford to investigate.
Dr. Richard Popp, Stanford's senior associate dean for academic affairs, said Neal provided a ''massive amount'' of what he called ''disorganized'' information.
Popp finally opened an inquiry into the charge of scientific misconduct. But university officials contend that by that time, some of the allegations, including Neal's claim of medical journal fraud, had been thrown out by the Georgia courts.
Neal, who freely admits that he has become obsessed with exposing the Nezhats, was running up a list of legal setbacks. In his dogged pursuit of the Nezhats, he was building a reputation as a crank.
He was disqualified from the malpractice case by a Georgia judge in 1995 for ''unethical behavior'' and could no longer represent Mullen. After a federal judge last year tossed out his attempt, on behalf of another client charging malpractice, to use racketeering charges against the Nezhats, Neal was charged with contempt of court. The judge also assessed $384,000 in ''sanctions'' against the plaintiff and her remaining attorneys. The sanctions are on appeal.
Neal denies the unethical conduct allegation, and the contempt of court charge was recently dropped. The only thing he is guilty of, he says, is aggressively representing his clients against institutions willing to look the other way.
''These guys are bad doctors, some have even said evil, and they have to be stopped,'' he said.
WITNESS, 1996
Shortly after Dr. Tom Margolis joined Stanford as an assistant professor and chief of pelvic surgery, Farr Nezhat invited the newcomer to watch him perform a complex laparoscopic procedure.
During the operation, Nezhat cut the patient's ureter. Margolis, who had also served as director of urogynecologic/pelvic surgery at Northwestern University Medical School, assumed it was an accident, a known but unwelcome complication of the difficult surgical technique. He stepped in to assist Nezhat in repairing it.
But a short time later Margolis learned that, in a post-operative review session and the operative report, Nezhat described the cut as deliberate. He said he sliced the ureter to remove endometriosis that could have blocked urine flow.
Margolis was outraged. He said that he saw no endometriosis on the ureter and that the pathology report proved it.
''It was clear that Dr. Nezhat was performing an unnecessary procedure,'' he said in a sworn affidavit.
THE POLAN MEETING, 1996
More than two years passed before Stanford's quality assurance committee took up the review of the five cancer cases in which Spirtos had alleged improper surgeries by Camran Nezhat.
Just before the review committee was finally set to meet, Dr. Mary Lake Polan, chairman of obstetrics and gynecology, dropped by Margolis' office. He was one of the physicians reviewing the cases.
''We need to make sure that Nezhat is cleared on all these (cancer) cases,'' she told him, according to his affidavit.
Ultimately Margolis - and the other members of the quality assurance committee - voted in favor of Nezhat on all charges.
Polan said Margolis' allegations are false.
''I adamantly deny the statements attributed to me and deny there has been any pressure to exonerate any physician during the quality of care committee process," she declared in a written response to The Chronicle.
Margolis' decision to vote to exonerate Nezhat would haunt him for more than a year, until finally he had to act.
THE SHUER LETTER, 1998
In April 1998, Margolis met with Dr. Lawrence Shuer, chief of staff of the medical center. He told Shuer about the cut ureter incident and the pressure Polan had allegedly exerted on him.
''He (Shuer) acutely and abruptly ended our conversation, and I was excused from his office,'' Margolis said.
More than a year later, when Shuer learned Margolis was still criticizing the Nezhats and Stanford, he sent a written warning:
''Rest assured that Stanford Hospital and Clinics intends to pursue its full legal remedies if these defamatory and libelous statement do not cease,'' Shuer wrote.
Furious, Margolis, who had left Stanford to practice with Spirtos at the Women's Cancer Center in Palo Alto and Los Gatos, wrote back, saying that Shuer's job as chief of staff was ''patient protection not doctor protection.''
''The data which (the Nezhats) have published, including the rectal eversion procedure, is fraudulent, yet their publications are being accepted as standards in the surgical community. Stanford, by not auditing this clinical data, has ignored the concerns of scores of surgeons,'' Margolis wrote.
STANFORD'S DUTY, 2000
Defenders of the Nezhats at Stanford dismiss both Spirtos and Margolis as jealous competitors. But other medical experts say Stanford should have demanded a review of the 16 cases and has shirked its responsibility to verify the Nezhats' research claims.
''Stanford has a duty to review this,'' said Dr. Warren Grundfest, chairman of Biomedical Engineering at UCLA and an expert in new medical technologies. ''Serious allegations have been made by credible people, but Stanford has played like an ostrich with its head in the sand.''
But Stanford officials contend they are not obligated to review the 16 patient records because the rectal surgeries were performed in Georgia before the Nezhats came to the West Coast. Shuer said the procedure in question has never been performed at Stanford.
It was appropriate for the Nezhats to leave Mullen's case out of the medical journal, according to Stanford, because she was ultimately found not to have rectal endometriosis like the other patients.
Stanford reviewers have never asked the Nezhats or Northside Hospital for the records to verify the accuracy of the other 16 cases. ''We have no right to the records and do not want to violate patient privacy,'' said Stanford's lawyer Debra Zumwalt.
The university also never interviewed Mullen or the 20 doctors who have expressed concern over the Nezhats' research.
According to Stanford, the appropriate institutions to investigate the Nezhats are Northside Hospital, the Georgia Medical Board and Mercer University, where the Nezhats were clinical professors at the time of the surgeries. ''Stanford will carefully review the conclusions of those investigations,'' said Popp.
But a spokesman for Mercer, a Macon, Ga., medical school founded in 1986, said the school has no investigation pending.
The Georgia Medical Board's investigation of the Nezhats is continuing. The board will not comment on its status.
Stanford attorney Zumwalt said Margolis' complaint to Shuer regarding the cut ureter incident was never put in writing. Shuer said he asked Margolis for more information, and none was provided, but the case has now been identified and is being investigated by the quality assurance committee.
The university said the Nezhats have been cleared of allegations that they operated outside their specialty. Officials would not comment, however, on any details of the five quality assurance cases because they are confidential.
''One thing I can point out,'' said Zumwalt, ''is that doctors and patients and their families can reasonably disagree as to how aggressive to be in treating terminal diseases.''
GEORGIA COURTROOM, 2000
Mullen has refused to engage in monetary settlement talks with the Nezhats and promises to continue her suit until the records of the 16 other women are made public.
''My life has been changed in a very horrible and profound way by the experiment (that) Camran Nezhat has conducted upon me without my knowledge,'' Mullen said in an affidavit. ''I despair that other women will be injured by well-meaning surgeons who believe Camran Nezhat's article that there were no complications from this new surgery.''
In November, after a battle spanning six years - and six judges - Superior Court Judge Melvin Westmoreland in Atlanta ordered a confidential release of the records to Mullen's lawyers, and in January, the Nezhats and Northside Hospital turned them over.
While the records remain sealed, medical experts hired by Mullen's legal team to review the documents have written Judge Westmoreland expressing their concern about what the records contain, and urging that they be unsealed, in the public interest. ..
William Carlsen can be reached at wcarlsen@sfgate.com. Sabin Russell can be reached at sabin@sfgate.com.
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2000/04/05/MN29STA.DTL
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