New prostate cancer treatment drawing U.S. patients, doctors to Mexico

Not long after Dick Schwab learned he had prostate cancer at age 56, he flew to Mexico for a procedure not approved in the United States. As he joined a rising tide of medical tourists going abroad for treatment, Schwab's October trip had a twist: His Austin doctor joined him in Cancún, Quintana Roo, on Mexico's Yucatán Peninsula, to do the procedure.

Schwab, general manager of an industrial uniform service company, said Austin urologist Richard Chopp encouraged him to learn about his options, including the standard treatments for prostate cancer: radiation to kill cancer cells and surgery to remove the prostate. After two months, he decided on high-intensity focused ultrasound, which heats the prostate to destroy cancerous tissue. Chopp told him it was being done successfully in about 30 countries and had lower rates of impotence and incontinence than the standard treatments.

But some leading urologists say that while the technology is promising, patients should be cautious about HIFU. Until clinical trials in the U.S. are completed, claims that HIFU is safe and effective and has fewer complications than more established treatments can't be assured, said Dr. J. Brantley Thrasher, chairman of urology at the University of Kansas
Medical Center and spokesman for the American Urological Association on prostate cancer.

"We need trials that give us good comparisons with our standards," said Thrasher, who said he disapproves of U.S. doctors going overseas to do procedures. "It would not be my recommendation" to have HIFU, he said.

Before traveling to Mexico, Schwab wrote a check for $25,000 to International HIFU, the Charlotte, N.C., company that created the machine Chopp would use. The company also booked Schwab's flight and hotel, although he had to pay those costs separately. After the two-hour, 20-minute procedure, Schwab was eating dinner that night with his wife in his hotel room. It was worth "every penny," he said.

Schwab, now 57, said that except for two doctor visits to correct some "sloughing off" of dead tissue that slightly impeded urinary flow, he's had no problems. "I'm still thrilled beyond belief," Schwab said.  "I feel I have a strong obligation to help people learn about this."

U.S. researchers say they haven't learned enough about HIFU yet to make judgments about it. And some have questioned the ethics of doctors being paid directly by a company for a procedure that must be performed in another country.

Procedure's risk
HIFU is different from standard ultrasound, which takes an image of an internal body part, because it uses two ultrasound probes. One is placed inside the rectum, which is close to the prostate, and focuses sound waves, working like a magnifying glass in the sun to produce intense heat that kills cancer cells, said Amanda Willis, vice president of marketing
and communications for International HIFU.

The company says the procedure can result in complications such as damage to the rectal wall, infections and blood in the urine. It said its device has been tested in Japan and Europe and has shown good results.

The Japanese study, the largest to date, tracked 662 patients, including 224 patients over 10 years who underwent procedures using the Sonablate 500 device made by International HIFU - similar to the device Chopp uses. The study said 1.5 percent of the smaller group of men experienced urinary problems and 34 percent experienced erectile dysfunction, according to an abstract published last month in The Journal of Urology. The study must undergo a more rigorous review before it can be published. Chopp, one of 200 urologists around the country who have been trained by the company to do the procedure, said he has done about a dozen in Mexico since September.

The American Cancer Society says traditional external beam radiation therapy can result in bladder problems for one in three men, while impotence can occur in as many as 50 to 75 percent of men, depending on their age and condition. For Dick Schwab, with wife Denise, chose to have a procedure not approved in those who had surgery to remove the prostate, impotence rates were similar - although sexual function sometimes improved over time - and urinary problems were more frequent than in men who had radiation therapy. Cryotherapy,
which freezes the prostate to kill cancer cells rather than heating it, had impotence rates of up to 80 percent, according to the cancer society.

It said one in six men will get prostate cancer - the risk rises with age - and one in 35 will die of it. Deaths are declining with earlier detection, and more than 2 million American men who have prostate cancer are alive today.

But early detection also has meant that prostate cancer is being overtreated, experts said. Some elderly men with slowgrowing cancer might be better off monitoring the disease, doctors say, adding that they are seeing fewer side effects from standard therapies than what the American Cancer Society reported. Even some younger men might benefit from
"watchful waiting," but because it can be difficult to know which tumors are deadly, most men opt for treatment, as Schwab did.

"Knowing I have cancer, that (monitoring) doesn't really make sense to me," Schwab said. "I'm pretty much about - let's handle this. I've got cancer; let's do something."

Dr. John Ward, an assistant professor of urology at the University of Texas M.D. Anderson Cancer Center in Houston, said he is a proponent of the new technology and is doing clinical trials on a rival device from a French company called EDAP. He expects to test International HIFU's equipment soon, but he said he is concerned about patients being seduced "with the flash of technology" and the promise of better outcomes while the trials are under way. Ward said patients should consider enrolling in clinical trials in the United States rather than paying out of pocket to leave the country for procedures. "We need to learn the proper patient that can benefit most from this technology," he said. "It's not right for everybody." HIFU is not for patients with later-stage disease, Ward said, and it can't be done in patients whose prostates
are too enlarged.

Financial concerns
Although Chopp claims HIFU is cheaper than standard treatments, many patients could pay much more in the end because insurance might not cover it. Schwab said he chose HIFU not to save money but to avoid impotence and incontinence. To his surprise, his insurance company reimbursed him for all but about $2,500 for the procedure, he said.

International HIFU, which has been in business for five years, says it charges patients $25,000 to $30,000 for the surgery and pays the doctor's fee out of that. Doctors get $3,000 for the procedure and another $3,000 if they take care of patients before and after it, said
Willis, the International HIFU vice president.

The American Board of Urology said in a statement it is concerned that some doctors could be encouraging men to get HIFU not because the treatment is in the best interest of the patient but because it is in the doctor's financial interest.

But when Dr. Stuart Howards, the board's executive secretary, was told that International HIFU pays doctors a maximum of $6,000, he said he did not find the amount to be excessive. Thrasher, the American Urological Association spokesman, said having a device company directly pay for a doctor for a treatment is not the way medicine is practiced in the U.S., where fees are set and then paid through fee schedules established by insurance companies and hospitals. "I see it as a medical/legal issue, I see it as an ethical issue, and I see it as a patient safety issue," he said.

The urology board also raised concerns that safeguards to protect patients "may be absent or far less stringent in foreign countries" than in the U.S. In Canada, doctors must be licensed in that country to do the procedure; in Mexico, U.S. doctors do the procedure as
technical advisers, Willis said. They work with a Mexican urologist, and Chopp said that doctor is generally in the room with him while Chopp performs the procedure.

The company is aware of the criticism and has responded by opening its policies, procedures and fees to scrutiny, Willis said. "We have been an open book with all of those organizations," she said. "We have asked for feedback and have gotten nothing back."
Chopp, who said he performs HIFU on about two or three patients a month, doesn't see the fees he receives as excessive. "I have to pay for my airfare down and back; I have to pay for my hotel; I have to pay for my meals," he said. "I'm not doing it for the money. It's the treatment I would pick if I had prostate cancer." He said concerns about the safety of doing the procedure in other countries are unfounded. The Food and Drug Administration's "counterparts in other countries are equally as restrictive, and I think in some cases, more so. They have looked at this technology and approved it. ... I think the United States is the last place open to question ... and it will be approved here eventually."

Schwab disagrees with U.S. urologists that patients should wait until HIFU is FDA-approved.
"It seems crazy to me that no one else's research counts," he said. Several urologists said
they hope patients wait the couple of years it could take the FDA to rule on the procedure's
safety and effectiveness.

"It sounds encouraging, and there's potential," said Dr. Anthony Smith, professor and chief of
urology at the University of New Mexico. But "our country has decided this treatment is not
ready for prime time."

Three Central Texas Locations to Serve You

North Austin Location

11410 Jollyville Road, Suite 1101

Austin, Texas 78759

Tel: 512-231-1444 / Fax: 512-231-1470

Toll Free: 877-231-1444

Round Rock Location

511 Oakwood Boulevard, Suite 103

Round Rock, Texas 78681

Tel: 512-828-5522

Fax: 512-828-5511

South Austin Location

5656 Bee Caves Road, Suite D-200

Austin, Texas 78746

Tel: 512-328-1313

Fax: 512-328-1316