Unproven cancer therapy lures U.S. men to Mexico

PUERTO VALLARTA, Mexico — Some weekends, more than a dozen American men wait at beachfront hotels, eager for their turns in the treatment room at a small private hospital here.

They are medical tourists with prostate cancer. And they are queued up for the latest therapy — one advertised with pictures of couples strolling on the beach and pitched as a way to treat patients' disease while preserving their sex lives.

The treatment is called high-intensity focused ultrasound, or HIFU (pronounced HIGH-foo). And instead of using surgery or radiation, it attacks the cancerous tissue by heating the prostate to temperatures near boiling.

Tropical beaches aside, there is a reason that hundreds of American men have traveled out of the country to receive HIFU. It is not approved in the United States. And its growing popularity has some cancer experts voicing caution over US HIFU, the company sponsoring the offshore treatment weekends.

The company is attracting attention for its aggressive recruitment of American doctors who will go through training and perform the treatments. The company charges patients $25,000 to $30,000, a fee that is usually not reimbursed by insurance. Of that, the company pays the doctors $5,000 to $7,500 — several times more than what physicians earn for conventional prostate-cancer procedures in the United States.

Critics worry that financial motives might influence medical decisions.

"The people doing the treatments down there, they're just printing money," said Dr. Thomas Gardner, an Indiana University School of Medicine urologist who has been involved in clinical studies of HIFU and who, despite his concerns, is enthusiastic about its potential. "Anytime anyone's printing money," he said, "doing what's right for the patient gets a little blurry."

But Dr. George Suarez, medical director of US HIFU, which is based in Charlotte, N.C., defends the company's fees, which are less than the cost of some other prostate-cancer treatments. And he says he recommends the treatment because he believes it works as well as surgery or radiation, with fewer side effects.

The company says it has treated more than 1,000 men in its centers since 2004. Stephen Puckett, the company's chairman, said those patients "should have the right to choose their medical treatment and to choose where to have it."

One of those patients is Gary Crissman, 54, a manufacturer's representative from Pittsburgh, who was among five Americans treated at the small private hospital here one weekend in December. He arrived for his three-hour procedure wearing a T-shirt that proclaimed, "Hey cancer, you picked the wrong guy."

Crissman said he had considered surgery and radiation, but worried about the common side effects of both — sexual impotence and urinary incontinence.

"I didn't want to have the problem of potentially leaking, and I didn't want to have the problem of erectile dysfunction," said Crissman. Afterward, he said, his procedure was such a pain-free "breeze" that he celebrated with a Mexican buffet dinner in his hotel's restaurant.

Positive patient testimonials can be found on the company's Web site, which also lists the company's treatment sites elsewhere in Latin America and the Caribbean and affiliates in Canada.

Not every customer has a good experience, though.

"The US HIFU site makes it all sound rosy; they give you none of the side effects and none of the bad results," said Fred Gillick, a Park Ridge, Ill., real-estate executive who received the treatment here in April 2006.

Gillick, 69, says the procedure left him impotent and he must wear a catheter at all times. Worse yet, he said, the treatment did not eliminate his cancer.

"Guys, there's a reason HIFU isn't approved here," Gillick said in a Web posting on a cancer support site.

In the treatments performed in Puerto Vallarta, after patients are sedated and given spinal epidurals, they lie on an operating room table with their legs in stirrups. The treatment is delivered through a probe inserted into their rectums.

During the treatment, doctors monitor a video-screen image of the prostate. Because each dose of highly focused ultrasound is delivered in short spurts to small areas, it can take several hours. Crissman, the patient who described the procedure as "a breeze," said the only discomfort was the catheter, inserted directly into his bladder through an incision below his navel, that all patients wear for about two weeks.

In telephone interview three weeks after the procedure, Crissman described his condition as so far, so good. "Everything works," he said.

Although the company's international treatment sites are outside the jurisdiction of the Food and Drug Administration, the company is sponsoring FDA-approved clinical studies in the United States geared toward getting approval of the therapy. The treatment is approved in the European Union and Canada, where some American men have traveled for treatment at centers operated by various providers.

But there is skepticism among leading American doctors, as well as the American Urological Association, which has said there is too little long-term data to evaluate HIFU.

The primary treatments for prostate cancer have an impotence rate approaching 50 percent, as well as a lesser risk of urinary incontinence. Suarez and Dr. Stephen Scionti, who performs many of the company's HIFU procedures in Puerto Vallarta, said that they can reduce impotence rates to the single digits.

The head of the prostate-cancer program at Memorial Sloan-Kettering Cancer Center in New York, Dr. Peter Scardino, said the procedure might prove useful for some special cases, but "for the treatment of the average ordinary prostate cancer, I think it's a second-class form of therapy."

Scardino is among prostate-cancer experts concerned that when HIFU treatment preserves sexual potency, it is not eradicating the cancer. "I don't think you can treat the entire prostate gland with this heat," he said, "without causing all the same side effects that people worry about with surgery or radiation."