Controversial Cancer Treatment in Cancun

CANCUN, Mexico, June 6, 2008 — -- Most Americans go to Cancun in the winter to escape the cold, have fun in the sand and bake in the sun. But that is not what brought Richard and Diane Brightmire all the way from Denver.

"I'm off to a hospital to improve my life," said Richard Brightmire, as he and his wife left their hotel at sunrise and loaded into a waiting van.

Brightmire, 61, has prostate cancer. He came to Mexico for medical treatment at a private hospital just 20 minutes from the beaches of Cancun — treatment that he can't get in the United States, even though it was developed there and is legal just about everywhere else in the world.

The treatment — called HIFU or high intensity focused ultrasound — literally burns the prostate and cancerous cells using focused ultrasound waves.

Europe, Canada, Japan, Mexico and many other countries have accepted the science behind HIFU, but the U.S. Food and Drug Administration has demanded lengthy scientific trials before the technology will be approved for use here.

Prostate cancer is the most common cancer found in U.S. men. Conventional treatments usually involve surgical removal, radiation or hormone injections.

After two years of holistic treatments, Brightmire's cancer hadn't gone away and his urologist in Denver told him it was too advanced to ignore. Brightmire didn't like the options his urologist offered, particularly the possible side effects and consequences of the procedures.

"They probably eliminate the cancer but you have to live in so many cases with the undesirable consequences," he said.

What Brightmire is talking about are some of the biggest fears facing men with prostate cancer. In eradicating the cancer, the prevailing therapies — surgical removal, radiation seeds, freezing and hormone therapy — can have devastating effects on urinary and erectile function.

The possibility of a better outcome is why men like Brightmire are willing to travel to Mexico and spend $25,000 of their money on an experimental treatment.

George Suarez is the medical director of USHIFU, the American company behind the technology. A licensed and practicing urologist in Miami, he travels to Cancun most weekends to provide the treatment.

Kill the Tissue, Kill the Cancer

HIFU is 21st-century medicine — no incisions, no blood and the entire procedure takes just a few hours.

"This is completely hands off, image guided," Suarez said as he prepared to insert an ultrasound probe inside Brightmire, who lay on the operating table under anesthetic. "Once I place the transducer into the patient, I should not need to touch the patient until I'm finished. Everything will be done by the computer."

Gradually, an ultrasound image of the prostate began to appear on the computer screen.

"What we're going to do is we're going to mark off the prostate area that we want to treat," Suarez said, explaining how he would use the computer to mark grids of 3-millimeter-wide lesions that would cover the entire prostate. "It'll burn off that region."

Suarez was quick to add that he was "not going to boil it to the point one would think of it. The idea is to kill the tissue and to kill the cancer. Both."

Burn by microscopic burn, the prostate — and they hope the cancer — will be killed. The ultrasound allows the doctor to identify and, in theory, avoid critical nerves and blood vessels.

It is a procedure that Patrick Walsh, a urologist at Johns Hopkins and one of the world's leading experts on prostate cancer, said he would never recommend to his patients.

"I think it's entirely experimental," Walsh said. "That any enthusiasm that's been engendered for it is really coming from the industry that makes the machine."

Walsh is referring to the Sonablate 500, the high-tech machine used to perform the procedure. Suarez has part ownership of the company that makes it.

But the enthusiasm is real, and it's easy to see why. Suarez claims his success in curing cancer is equivalent to that of conventional methods, but the real selling point is the claim that there are fewer side effects.

"Our goal is to treat this man, eradicate his cancer and return him to baseline function as far as sexual function, urinary function and rectal function," Suarez said.

It is the neurovascular bundles that control a man's erectile function. Suarez uses the ultrasound to identify them and avoid damaging them.

"I'll treat right up to the neurovascular bundle," he said. "And by not treating beyond the neurovascular bundle, I'll be able to perform a potency-sparing HIFU procedure and hopefully decrease the risk of erectile dysfunction in this patient."

It's not every day that you see a doctor bring a plate of fruit into an operating theater, but because this procedure does not require a sterile environment — there's no surgery happening here — Suarez thought some props would help us understand.

"I've had them bring in a grapefruit," he explained, pointing to a half grapefruit on a tray. "And if you took this grapefruit, and the outer part of the crust was a prostatic capsule [the shell of the prostate], what we're going to do with HIFU is we're going to create lesions across the prostate so that, in the end, the only thing that is left intact is the prostatic capsule or the skin of the grapefruit."

Scientific Skepticism

"I think it's being hyped," Johns Hopkins' Walsh said of the procedure. "I think that people have skipped over a critical analysis of cancer control, and I think physicians are being encouraged to do it because they can make a lot of money."

"Nightline" spoke with more than a dozen leading American urologists who share Walsh's skepticism of HIFU.

Mark Soloway, chairman of the Department of Urology at the University of Miami School of Medicine, said many men who seek HIFU and the more conventional traditional treatments don't need them. Prostate cancer grows so slowly that active monitoring is often the best option.

"One in six men in the U.S. will have prostate cancer in their lifetime. How many will die? One in 35. That tells you right away that most men will not die of this cancer even if followed for 15 to 20 years."

Suarez insists that the procedure works.

"I think more than anything I could tell you that could make you believe in me is the number of patients that have had very successful treatment," he said. "I think the outcomes of the therapy speak for themselves."

But that doesn't satisfy critics who want to see what science says about the procedure. Suarez says USHIFU has treated more than 1,000 men in the last five years in Cancun, Canada and across the Caribbean, but he only tracks medical results by what he calls patient "testimonials." He can't supply solid scientific data that proves his patients are cancer free with fewer side effects.

Suarez directed us to a Japanese study that found promising results from HIFU: It found a cancer cure rate of 91 percent for low-risk patients and reported that 80 percent of patients retained sexual function. But other studies "Nightline" reviewed found far less favorable results.

"All therapies have some degree of efficacy," Suarez said. "But efficacy is not always the entire answer. The collateral damage and other issues are equally important to patients."

Walsh said, "There is no good evidence at this point that HIFU can effectively cure prostate cancer without significant side effects."

The most common treatment for advanced prostate cancer is surgical removal. And in the hands of a skilled surgeon there is no question it works. Most men are cancer free after five years, but on average 50 percent of them will be left impotent. And that may be why men like Brightmire are prepared to take a leap of faith and pay the hefty price.

"The truth of the matter is it costs less than an operation in the United States, less than radiation therapy," Suarez said. "[It's] a fraction of what an American would be paying if he had to pay out of pocket."

His critics disagree. They worry that Suarez has a major business incentive to promote the procedure.

Suarez counters that he has sacrificed a large part of his practice by spending so much time away from it. "I could stay at home and probably have more financial incentive to operate," he said. "But the fact is … I do believe in this technology."

'Disease Won't Wait'

It is not just patients who are making the pilgrimage to Cancun and to Canada for this procedure, so are American urologists such as Hugh Solomon from Ann Arbor, Mich., and Gene Rosenberg from Hackensack University Medical Center in New Jersey.

Both men came to Cancun at their own expense to learn more about the procedure, even though FDA approval is still years away. Suarez said that "we've had several hundred urologists come for training."

"I'm here because there are many patients in my practice who don't fit into the usual treatment protocols that we have," Rosenberg said.

He added, "The United States, justly so, wants to see the evidence before they allow it to be used in the United States. I think that's a fair requirement. However, many of our patients' disease won't wait for that time to come."

Brightmire didn't want to wait, and he was willing to pay the steep price as well as the travel costs. Brightmire is no Palm Beach millionaire. He's a former Army helicopter pilot and a former National Park Ranger who dipped into his savings to pay for the treatment.

"I flew helicopters all my life and they needed maintenance and so I see the same is true for my body," he said the night before the operation. "And it costs a lot of money and time to keep a helicopter flying safely, so I do not mind putting the money into my body."

He added that "a lot of people worry about the expense, but I don't think you can put your money into anything better than yourself, your health."

An hour after the procedure was over, he walked out of the hospital holding his wife's hand. He said the day marked "a new beginning" with "no cancer."

That is certainly the hope. He's betting his life and $25,000 on it, and he will have to get tested regularly to know for sure.

A day after the procedure Richard and Diane Brightmire went for a walk on the beach. A stranger would have no idea that instead of coming to Mexico for some sun, Brightmire came to burn away his cancerous prostate.

After the treatment in early February, Brightmire reported that he had recovered quickly from the procedure, with no side effects. He has since had a follow-up PSA test that came back with a zero score, which is exactly what he was hoping for, but it will take years to determine whether this unproven, 21st-century treatment leaves him cancer free for good.