ADR Article in Orgenonian

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Full text of article posted below...

A client of mine sent me a link to this artcile yesterday. (link good at time of posting) It's an article about 3 spine patients who went overseas. Folks who've been here for a while will recognize Rob Wilson as on of the Stenum patients with vascular complications. I'm very familiar with both Rob and Dr. Kari Swarztrauber as they are GPN clients. I look forward to seeing them post about the article here. There is much to say about the article and I'll post more later.

Mark

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Destination surgery lures Oregonians
Those with back pain and other ailments are finding relief overseas

Monday, July 09, 2007
PATRICK O'NEILL
The Oregonian Staff

The pain in his back got so intense Phil Chizum wondered whether life was worth living. It began in earnest five years ago when Chizum, owner of the Glass Butterfly clothing stores, hefted a large box of dresses in his Lake Oswego shop.

"I bent over the wrong way, and my back went out," he said. He couldn't work for two months. Chizum had battled back problems for the previous decade -- enduring episodes when his spine would "lock up." Walking was sometimes difficult, never mind the sports he loved -- skiing, golfing, tennis and basketball. And sometimes he'd wind up bedridden for days. A year ago, the pain moved to Chizum's legs. "It felt like my feet were standing in fire," he said. "It felt like knives were stabbing me in the thighs."

Chizum, 48, said he sought help from 10 physicians, had seven steroid injections, was treated by three physical therapists and took half a dozen drugs in an effort to tamp down the pain. But nothing. Doctors told Chizum he'd simply have to live with it.

"I got to the point where I wanted to die," he said. Chizum didn't realize it at the time, but his pain pushed him into the ranks of Americans who seek a type of surgery that is available in Europe but not the U.S.

The procedure, in which two or more spinal discs are replaced with artificial ones, is federally approved in the U.S. only for research purposes. But that's not the case in Germany, where the approach to spinal surgery is looser.
Surfing the Internet on Christmas Day, Chizum found a site operated by Stenum Hospital near Bremen, Germany, promoting the procedure. Stenum is so open to foreign patients it has a U.S. marketing representative in Medford-based Jim Rider, who three years ago became the first American to undergo multiple-disc surgery at Stenum.

With the urging of his wife, Chizum sent his X-rays to Germany. He signed up. When he woke up in Stenum's recovery room Feb. 2, the pain in his legs was gone. A week ago Chizum returned from a Caribbean cruise where he played tennis and 36 holes of golf.

"My back has not felt this good in 15 years," he said.

Chizum paid $32,000 of his own money for the surgery, which insurers decline to cover. But for Chizum, the money -- and the many risks of traveling afar for a procedure -- were never in the way. He weeps at the memory.

"I was willing to risk my life for this surgery," he said.

Stenum now operates on roughly 200 Americans a year, thanks in part to the efforts of Rider, in Medford. But it's just a dot in a global marketplace of surgery that entices more and more Americans to travel for a solution.

The phenomenon, known as medical tourism, has grown with the Internet and is dominated by clients saving money on procedures costing far more in the U.S. The list is long -- cardiac, dental, cosmetic -- and driven by the fact that most foreign surgeries cost less than half what they would here.

Joe Woodman, author of the popular book "Patients Beyond Borders: Everybody's Guide to Affordable, World-Class Medical Tourism," estimates Chizum is just one among roughly 150,000 Americans who journey each year to a foreign country for surgery.

In February, the American Society of Anesthesiologists' Newsletter reported that countries including Thailand, Malaysia, South Korea, South Africa, Costa Rica, Belgium and Poland promote themselves as treatment destinations. Big-ticket surgeries include coronary bypass, knee and hip replacement, spine surgery, plastic surgery and eye operations.

"The main reason people travel is to save money," Woodman says.
But a growing number, like Chizum, are seeking procedures that are unavailable here.

Many spinal options
Back pain in America is one of the most widespread and intractable problems of an aging population. Doctors offer few options, and patients often are unhappy with treatment results.

Yet Stenum Hospital's Web site is so matter-of-fact: "At Stenum Hospital the doctors can select your spine solution from an extensive list of globally available options. Multi-level ADR (artificial disc replacement), Lumbar and Cervical, is common, and ADR adjacent to fused levels is done with great success."

The spine is a delicate string of bones called vertebrae housing the spinal cord. Between each vertebra is a rubbery pad called a disc, which acts as a lubricated cushion, allowing the spine to bend. Discs can shrink and distort with age and heavy use, pressing on nerves and causing pain. Surgeons use a variety of procedures to take away the pain. One, fusion, immobilizes two adjacent vertebrae to keep spinal nerves from being irritated. Fusion sometimes fails and can restrict mobility.

But another solution is to replace the damaged discs with artificial ones.
Practiced for the past 20 years in Europe, the surgery has been available in the U.S. only since 2004, when the U.S. Food and Drug Administration approved the first artificial disc. But a subsequent refinement of the procedure, in which two or more adjacent discs are replaced -- the kind Chizum sought -- is approved by the FDA only for experimental use.

Insurance is a long shot. Angela Hult, spokeswoman for Regence BlueCross BlueShield of Oregon, said her organization won't cover any artificial disc implants, which it considers "investigational." Despite FDA's approval of single-disc surgery, BlueCross is not convinced the technology works any better than fusion, Hult said.

Measure of desperation
Dr. Karleen Swarztrauber, 43, a neurologist at Providence Newberg Medical Center, knows firsthand the desperation of patients with back pain. Not only does she treat them, she was one.
Several years ago, the athletic physician was heavily involved in windsurfing, horseback riding and skiing when she suffered a "severe and bizarre spasm" of her lower back muscles. Within two years injured discs in her lower back brought on chronic back pain for which physicians, acupuncturists, chiropractors and massage therapists could offer only limited help.
Swarztrauber, like Chizum, searched the Web and found the ProSpine Center in Bogen, Germany, offering multi-level disc replacements of the kind promoted by Stenum.

She views sending $20,000 -- half of the cost of the surgery -- to Germany as a measure of her desperation.

"My social life was falling apart because I couldn't sit at a restaurant," she said. "You can't see when it's going to end. You're as good as a paraplegic, except you're in pain." Intractable back pain, she said, "was a tremendously isolating experience, because nobody could see my disability."

Knowing that back surgery is never a sure cure, she, like Chizum, was willing to gamble. And it worked, if not perfectly. She plays sports and can sit comfortably. But her back doesn't bend as easily as before.

Swarztrauber has not advised any of her patients to follow suit. She says the procedure isn't for everyone with back pain, and insurance doesn't normally pay the $30,000 to $40,000 required.

Some folks have downright bad outcomes, too. Rob Wilson, 51, an Akron, Ohio, purchasing manager, said his 2006 double-disc replacement at Stenum went awry, causing internal bleeding, and failed to relieve his back pain.

"There's no real way to check out its quality," Wilson said of a foreign hospital. "The only thing you can do is get references -- and all the references I had were good."

Differing regulations
But others, like Chizum and Swarztrauber, are likely to continue to make the trip for unapproved treatments. Dr. Aaron V. Kaplan, director of device development at Dartmouth-Hitchcock Medical Center at Dartmouth Medical School, has written about the differing medical regulatory environments of the U.S. and Europe.

European officials are concerned more with the safety of medical devices than with their effectiveness, he reports. But the FDA requires studies that demonstrate devices are both safe and effective -- a regulatory hurdle that takes more time. In Europe, physicians simply decide whether a device works -- a key difference from the American model. European medical devices do have to pass a review process by private organizations, but the reviewing is not extensive.

The device you'll be getting, by its nature, is new and is not as well evaluated -- and that has its risks," says Dartmouth's Kaplan.

Dr. Daryll C. Dykes, a surgeon and researcher at the Twin Cities Spine Center in Minneapolis and spokesman for the American Academy of Orthopedic Surgeons, says researchers in the U.S. "have not done studies on the multiple-level procedures. Also, there are no good studies anywhere else in the world on multiple-level procedures." Studies in the U.S. of single-level disc replacement, meanwhile, show that it can benefit some patients, he said. Yet the risks multiply if things don't turn out right.

If an artificial disc fails, Dykes said, removing it can be hazardous. In both disc implantation and removal, the surgeon enters the patient's body through the abdomen, pushing aside organs and major blood vessels to reach the spine.

"The revision operation is a huge deal," he said. "You're operating in a field that has . . . scar tissue. You take an uneventful procedure and turn it into a life-threatening surgery."

Chizum said he's willing to face that possibility. If his devices should fail him, he'll take it in stride. Before the surgery, "I didn't want to live," he said. "If I can live for just 10 years without pain, I've already won."