Health & Beauty | January 2008
|Despite Doubts, Cancer Therapy Draws Patients|
Stephanie Saul - NYTimes
go to original
Puerto Vallarta — Some weekends, more than a dozen American men wait at beachfront hotels, anxious for their turns in the treatment room at a small private hospital here.
|Fred Gillick has complications from his cancer treatment. (Peter Wynn Thompson/The New York Times)|
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 the 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. They argue that there is not yet enough evidence that the treatment stops cancer over the long run and they say the side effects are not as minimal as described by 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 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 A. 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, doing what’s right for the patient gets a little blurry.”
But Dr. George M. 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 that it works as well as surgery or radiation, with fewer side effects.
Nearly a quarter-million cases of prostate cancer are diagnosed in American men each year, and newer detection methods and increased vigilance mean that more cases can be caught while the disease is still curable.
Even earlier detection is expected with the advent of new genetic tests, like one announced Wednesday, that can identify which men are at high risk. Despite such advances, though, doctors still cannot predict which cases of cancer will spread. And so most cases are treated, even though most prostate cancer is slow-growing and in many cases would be harmless if left alone.
The company says it has treated more than 1,000 men in its centers since 2004. Stephen R. Puckett Sr., the company’s chairman, said that 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.
Mr. 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 Mr. 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.
Mr. 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,” Mr. Gillick said in a Web posting on a cancer support site.
Even patients whose testimonials appear on the company’s Web site do not always have good outcomes.
Charles A. Reinwald of Tequesta, Fla., said Dr. Suarez treated him in the Dominican Republic in June 2004. Mr. Reinwald’s statement on the site, written a short time later, applauded HIFU for what he said were minimal side effects.
But three and a half years later, Mr. Reinwald, now 82, said in an interview that his cancer was not cured. Still, Mr. Reinwald, a retired lawyer who is the founder of the Cancer Cure Coalition, an organization seeking new cancer treatments, said that HIFU should remain available and that he had not asked the Web company to remove his testimonial.
The company declined to discuss individual cases.
Dr. Suarez, who is also an owner of the company, said he set up a HIFU machine in the Dominican Republic five years ago after learning about the technology at a urology conference. That led to the formation of the company with Mr. Puckett, who previously founded the MedCath Corporation, a national chain of cardiovascular specialty hospitals.
Although the company’s international treatment sites are outside the jurisdiction of the Food and Drug Administration, the company is sponsoring F.D.A.- 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 also 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 head of the prostate cancer program at Memorial Sloan-Kettering Cancer Center, Dr. Peter T. 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.”
Dr. Scardino is among prostate cancer experts concerned that when HIFU treatment preserves sexual potency, it is not eradicating the cancer.
The primary treatments for prostate cancer have an impotence rate approaching 50 percent, as well as a lesser risk of urinary incontinence. Dr. Suarez and Dr. Stephen Scionti, who performs many of the company’s HIFU procedures in Puerto Vallarta, said that they could reduce impotence rates to the single digits.
But some doctors are skeptical of those figures.
Dr. Cary N. Robertson, a Duke urologist who has studied HIFU, said published research suggested that up to 50 percent of patients who undergo the therapy might lose all or part of their sexual function.
The company says that improvements in the equipment since those studies were completed have reduced impotence rates. There are also questions about whether HIFU’s long-term cancer cure rates are as high as those with standard therapies.
Citing a shortage of long-term data on the procedure, Dr. Scionti, who is based in Hilton Head Island, S.C., acknowledged, “We don’t know what the results are in 10 or 15 years.”
In the treatments done in Puerto Vallarta, after patients are sedated and given spinal epidurals, they lie on a surgical table with their legs in stirrups. The treatment is delivered through a probe inserted into the rectum.
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. Mr. 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.
“Let’s say they didn’t get all of it,” he said. “The procedure can be redone if necessary. At a later day, I still have the options of surgery or radiation.”
In a telephone interview three weeks after the procedure, Mr. Crissman described his condition as so far, so good. “Everything works,” he said.