Discussion of Trial and Barriers to Recruitment



Cancer's Enema No. 1? Make That 2 By Kristen Philipkoski

A study testing a controversial pancreatic cancer treatment that uses coffee enemas should by all rights be nearly complete.

But three years into it, Dr. Nicholas Gonzalez has only 25 of the 90 patients he needs to complete recruitment for the trial.

His clinical trial has been stalled by economics, logistics and outright prejudice against the twice-daily enema regimen, despite a promising pilot study.

"I'm the first person to say it: In the oncology world I'm a very controversial guy," Gonzalez said. "But we're trying to do very serious research."

Because pancreatic cancer is one of the most deadly types, it doesn't take long for researchers to find out if one treatment extends life longer than another. In the pilot study, Gonzalez's treatment more than tripled the 5-1/2 month life expectancy of pancreatic cancer patients on standard treatment.

Still, because the program is unusual, oncologists have not been chomping at the bit to refer their patients to the Gonzalez trial, which is being carried out by the Columbia College of Physicians and Surgeons.

Many seem troubled by the coffee enemas.

"I respect his willingness to have his regime studied," Barrie R. Cassileth, chief of integrative medicine at Sloan-Kettering, told the New Yorker last year. "But the coffee enemas are ludicrous. He ought to just get rid of them."

But Gonzalez said they are an integral part of the program. Caffeine stimulates certain nerves in the lower bowel, he said, that trigger a neurological reflex that makes the liver -- the body's main detoxification organ -- work more efficiently.

He says he follows the program himself as a preventive measure, works 14 hours a day and feels great.

"I thought (coffee enemas) were yucky when I first started doing them -- I had to get used to them," he said. "But I felt so much better from the first day that I never looked back."

Gonzalez began his latest study in 1999 with a $1.4 million grant from the National Institutes of Health -- a coup for an alternative treatment. The NIH predicted he would sign up the patients he needed in three years, but it's taken Gonzalez much longer.

"In the United States it's hard for a therapy that represents not only a different paradigm clinically but a different paradigm economically," said Peter Chowka, an investigative journalist who has reported on alternative medicine for 25 years and served as a consultant for the NIH Office of Alternative Medicine.

Gonzalez's treatment includes two coffee enemas every day, plus about 150 supplements in pill form and a strict organic and vegetarian diet -- none of which are patentable and therefore are not potential blockbusters for drug companies.

You can't even buy the supplements used in the treatment at a health food store. Gonzalez has them specially made for the clinic.

"You're not going to go to the store and find 'Gonzalez Supplements' with my smiling face on them," he said.

It's not the kind of treatment most oncologists are accustomed to. But Gonzalez believes conventional pancreatic cancer treatment is much more unpleasant.

"When dealing with oncologists I always say, 'You give bone marrow transplants to patients, injecting toxic drugs and almost killing them,'" Gonzalez said. "Compared to that, coffee enemas are not that big a deal."

Another reason oncologists might prefer to send their pancreatic cancer patients elsewhere is that pharmaceutical companies often pay a "bounty" of around $8,000 per patient when doctors refer them to drug makers' trials.

"It's a very common practice, and the competition for subjects is fierce these days," said Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics. Study volunteers are not always told about this potential conflict of interest, he added.

The rationale behind the bounty is that the oncologist loses a patient and should be compensated for lost income. But Gonzalez believes the practice skews trials.

"I don't think it should be that way, although it's perfectly legal and legitimate," Gonzalez said. "We're not doing that. This is a government study and government studies don't do that."

However, Jeffrey White, director of the Office of Cancer Complementary and Alternative Medicine at the National Cancer Institute, said that financial incentives don't actually work very well: Less than 5 percent of cancer patients in the United States participate in clinical trials.

Surveys also show that about half of patients never hear about the trials. And when they do, only about half of those patients are willing to participate.

What really gets Gonzalez riled is that some researchers suggest the patients in his pilot study may have been healthier than those in other pancreatic cancer studies to start with, thereby skewing results. One National Cancer Institute website, for example, mentions this possibility.

"That's a pile of garbage," he said. "There's no such thing as a group of pancreatic cancer patients that lives a long time."

Outside labs performed the diagnoses and biopsies for the patients in Gonzalez's pilot study, he said. Of 11 patients, eight were in stage four, meaning the cancer had spread to other organs.

Such a diagnosis is almost always a death sentence. Only 4 percent of all pancreatic cancer patients live five years or longer, and more than 80 percent die in the first year.

Gonzalez was incredulous that anyone might believe he could handpick "healthier" cancer patients.

"I have this magical ability to find pancreatic cancer patients no one has ever been able to find? We can outsmart an entire pharmaceutical company in our puny little office with one other doctor?"

In the National Cancer Institute's largest study of 126 patients, none lived longer than 19 months. In Gonzalez's pilot study, two patients lived for four years and one for almost five. The median survival time was 17 months.

Although Gonzalez looked at just 11 patients, it was impossible to ignore the data.

Despite the promising evidence, some patients are not willing or able to comply with the demands of the therapy, which also requires that patients take some of the supplements in the middle of the night.

But at 78, Edmund Rubin of Sarasota, Florida, says he's happy to comply with the regimen. Rubin was diagnosed with liver cancer in 1990. He took an interferon drug for nine months, which caused constant flu-like symptoms. Despite the treatment, doctors found a second tumor behind his ear. Fifteen radiology treatments later, the tumor was still there and doctors gave him six months to live.

That's when he heard about Dr. Gonzalez's treatment.

"In six months I regained my weight and the second tumor completely disappeared," Rubin said. "I had a CAT scan and bone scan a year later and there were no signs of tumors."

Rubin has been in remission for 11 years and still faithfully adheres to the Gonzalez regimen. He calls it "labor intensive" -- he can spend up to six hours a day administering it. It costs him about $6,000 per year and, although it's not covered by insurance, he gets about $2,000 back from the IRS.

Gonzalez began developing his treatment at Memorial Sloan-Kettering School of Medicine in the early 1980s.

During this time, Gonzalez compiled data from an orthodontist who became famous for treating Steve McQueen's cancer with coffee enemas and nutritional therapies, William Donald Kelley. For five years, Gonzalez analyzed Kelley's data, and by the time Gonzalez finished his immunology internship, he had written a 300-page treatise on Kelley's therapy.

Gonzalez was called crazy and a fraud, but he says the data was compelling and that's what mattered. He opened his own practice in New York City in 1987.

Despite the criticism, Gonzalez has played by the book. He wanted the opportunity to test his treatment, and he's gotten it. But he may have to wait several more years for results.

"No matter what one thinks of his approach," Chowka said, "I think you have to give him credit for the way he's gone about trying to validate it -- by working closely with the NCI and the NIH and all that entails, and by adhering to the scientific method."

Thanks to Wirednews.com


Phase III Gonzalez Protocol Trial

LINK to NCCAM site on this protocol

ALERT for Alternative Community

NYS Dept of Health complicates this trial, 1/03


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