More and more men are facing a medical conundrum: Either risk losing your sex life forever, or travel abroad for a $20,000 procedure that the FDA hasn’t approved yet.
Bowman first learned about HIFU while researching on the Web. The more
he learned about it, the better it sounded. HIFU technology was first
used to treat prostate-cancer patients in France in the 1990s, and was
refined by researchers at the Indiana University School of Medicine,
who developed the first version of the Sonablate machine. To date, HIFU
has been used on more than 20,000 patients worldwide, and the Sonablate
500 scored a success rate of 94 percent in patients with low-grade
localized cancer, according to recent research by Toyoaki Uchida, MD,
of Japan’s Tokai University.
“In the course of my sales work,” says Bowman, “I’ve sat in on a lot of
surgical procedures and seen things I’d like to forget. For my own
surgery, I wanted the least invasive, most controllable procedure
possible.” But Bowman quickly learned that this favorite treatment of
aging rock stars, airline pilots, and, intriguingly, American
physicians, comes with a significant catch: It’s not offered in the
United States (nor is it covered by U.S. insurers, for that matter). To
receive it, one must travel to Europe, Japan, Mexico, or Canada and pay
a fortune in medical expenses.
Bowman’s plight raises an important question: Why isn’t HIFU available
in the United States? “The FDA is very rigorous when it comes to
clinical trials for cancer treatment,” explains Naren Sanghvi, who
helped develop the Sonablate machine. “In the case of the Sonablate
500, studies must prove unequivocally that it resolves prostate cancer.
Then researchers must follow the trial participants for years to
determine that the cancer doesn’t recur.” In the United States, such
data has been slow in coming. The Canadian government approved the
procedure in 2004, but it is not covered by national health insurance
because Health Canada is still waiting on 10-year results and it pays
for the other treatments that are currently as effective.
In the summer of 2006, the Sonablate 500 passed the first round of
testing in the United States, which deemed it safe for clinical trials.
Last spring, clinical trials began at two clinics in Tennessee and one
in Texas. To enroll, visit focus-surgery.com. According to Sanghvi,
test data will be gathered and evaluated over the next several years,
and if all goes well, FDA approval will follow within the next decade.
“Every American urologist who looks at HIFU is intrigued,” says Ian
Thompson, MD, chair of the urology department at the University of
Texas Health Science Center at San Antonio. “But the big question, and
the greatest hurdle for FDA approval, is whether HIFU can be proved to
cure prostate cancer. And that takes time.”
Once the procedure is complete, it takes Bowman several minutes to
shake off the anesthesia. He emerges groggily, feeling his way back
into reality bit by bit, almost at the pace it took the Sonablate to
cook his prostate. News that the procedure was a success takes a while
to sink in. He is reluctant to sit up in bed, let alone take his first
steps down the hallway toward the recovery room, but once he gets his
legs under him, he feels a surge of relief and energy. He vows that
when he returns to Charlotte he will mount the soapbox about prostate
cancer.
“The week before the Komen Foundation’s Race for the Cure, you couldn’t
turn on the television or walk down the street without hearing about
breast cancer,” he says. “Well, September is National Prostate Cancer
Awareness Month in the United States. Are you aware of that fact? I
didn’t think so.”
Then, in midafternoon, almost exactly seven hours after Mike Bowman
entered the clinic, Dr. Barkin gives him the okay to leave. Bowman
accepts a nurse’s arm in the elevator, but once out on the sidewalk and
tasting the cool autumn air, he lets go. The nurse urges him to move
cautiously, to cross Bay Street at the traffic light, but Bowman,
declaring that he’s ravenous, is eager to get back to his hotel.
“Hell, let’s jaywalk,” he says, stepping lightly off the curb.
Three days later, back home in Charlotte, Bowman’s bladder function
returns to normal and a doctor removes his catheter. The next night,
his greatest fear regarding prostate-cancer surgery is laid to rest
.
