Imagine a tiny camera traveling through the body, taking pictures of potential ailments in the digestive tract. It's no science fiction movie.
By JENNIFER LIBERTO
Published July 29, 2003
It started with stomach aches, nausea and trips to the bathroom every 20 minutes. It didn't bother Joyce Manspeaker much, since the Spring Hill retiree lost almost 30 pounds, slimming to a size 12 in just a few months.
But as her potassium levels spiraled downward, Manspeaker, 63, grew weak and found herself in the hospital for a week-long barrage of unpleasant pokes, prods, drinks, scans and scopes.
Then her gastroenterologist suggested she try a different kind of test.
All she had to do was swallow a vitamin-size pill with a tiny camera inside and strap-on a 5-pound vest for a day.
No tubes, no nasty drinks? No problem, Manspeaker said.
"I've been through so many tests, this one will be easy," said Manspeaker with confidence one morning in April, as a nurse attached sensors to her chest.
With a "lights, camera, action" and a gulp, Manspeaker sent the $450 pill on its corporeal journey.
Pill camera comes to Tampa Bay
Capsule endoscopy consists of a tiny camera nestled inside a pill that takes thousands of pictures of the digestive system, including the hard-to-reach small intestine. It is becoming a standard tool among hundreds of gastroenterologists nationwide.
The pill camera arrived in the Tampa Bay area in March and April at five locations: at the office of her gastroenterologist, R.P. Kanuri of Spring Hill; Tampa General Hospital; Morton Plant Hospital in Clearwater; Town & Country Hospital in Tampa; Sun Coast Hospital in Largo; and East Pasco Medical Center in Zephyrhills.
Strangely enough, the concept of capsule endoscopy originated with the Israeli weapons industry. Given Imaging Ltd., which has its U.S. headquarters in Norcross, Ga., developed the pill based on an idea from a missile scientist who worked for an Israeli defense contractor who specialized in a technology that transmitted video images from missiles in flight to bases.
Capsule endoscopy works on a similar concept. The capsule starts photographing at a rate of two pictures per second the moment it is unwrapped from its packaging. Once swallowed, the capsule works its way through the digestive system and transmits digital images to antennae attached to the patient's chest. The sensors are wired to a data recorder, which the patient wears on a vest or belt. Patients can go about their day working, running errands or even dining.
Eight hours later, the patient returns the data recorder and the gastroenterologist plugs the $5,500 recorder into a $17,000 computer system. The computer downloads 50,000 pictures and then strings them together in a marathon movie that often ends with a flush.
"It's a one-time use capsule, so don't go looking for it or retrieving it," said Kanuri to about 30 people who shrieked with laughter during an informational lecture on the pill camera held in Spring Hill in June.
Breakthrough in technology
Even though the capsule takes pictures of the entire digestive tract, in August 2001 the Food and Drug Administration approved the device to be used only in the identification of small bowel disorders. That means capsule endoscopy won't be replacing the colonoscopy, the upper gastrointestinal endoscopy or the barium X-ray series any time soon.
But capsule endoscopy does offer some of the clearest color photographs of the small intestine, a 22-foot mystery. Previous technology relayed glimpses through fuzzy X-rays or enteroscopy, during which patients are given sedatives and anti-gagging drugs and told to lie still and swallow a long tube.
"We were leaving a large portion of the small intestine unevaluated," said Umesh Choudhry, a gastroenterologist at Morton Plant in Clearwater, where about a dozen patients have undergone capsule endoscopy. "This came as a really good breakthrough in technology."
In Manspeaker's case, her doctor saw red spots in the soft pink pictures of her small bowel and diagnosed her with arteriovenous malformations, or weak capillaries in the intestinal lining, which become inflamed and bleed, causing her to have diarrhea. Manspeaker is currently taking steroids for AVM.
Capsule endoscopy is slowly gaining acceptance in the health care industry. Medicare and several other private insurers, including Aetna and United Healthcare in Florida, have started reimbursing for the procedure. Medicare pays about $700 for the procedure.
A few weeks ago, the FDA dealt the Israeli company a small victory. They had approved capsule endoscopy for "adjunctive use," meaning it could be used along with more conventional tests. The FDA agreed to allow doctors to prescribe capsule endoscopy by itself for small bowel problems, FDA spokeswoman Sharon Snider said.
Given Imaging took that move a step further and issued a news release that the FDA announced capsule endoscopy as a "first line tool," in small bowel disorders, which sent Given Imaging stock soaring.
Capsule endoscopy is particularly heralded as a tool in the battle to diagnose Crohn's disease, a chronic immune system disorder that results in an inflammation in the small intestine and in the worse untreated cases can lead to strictures in the intestine, which must be cut out.
"One of the great problems is that Crohn's does go undiagnosed for great periods of time and is often discovered more advanced than it might, had it been diagnosed earlier," said Christopher Hughan, Florida chapter executive director of Crohn's and Colitis Foundation.
Yet capsule endoscopy is not perfect nor risk-free.
In clinical trials, comparative methods such as X-rays or enteroscopy found problems in the small intestine that capsule endoscopy did not detect in about 18 percent of the cases, according to records filed with the federal government. But, the capsule did find problems not detected by comparative methods in about 49 percent of the cases.
The capsule can also get stuck, especially in Crohn's patients, if their intestines swell shut and block the progress of the capsule, which would have to be surgically removed. But that happened in less than 1 percent of the clinical trials, Given's financial records show.
The biggest challenge for Given Imaging, which has so far sold about 550 systems through March 31, will be winning over more gastroenterologists. Analyzing the data takes a doctor 40 minutes to two hours.
And though Medicare and insurers are reimbursing the cost of the pill camera and the equipment, several doctors said they don't see their services being reimbursed adequately for the amount of time spent on the procedure.
Insurance companies generally pay doctors about $200 per procedure or about as much as they reimburse for an upper gastrointestinal endoscopy, "which takes half the time and one-tenth of the fatigue level," said Choudhry, the Clearwater doctor.
"A majority of doctors don't pick it up, because why should they do that when they can do two or three procedures in that same time and get paid three times as much," Choudhry said.
But winning over patients has proven much easier. Local hospital studies detailing their experience with capsule endoscopy often include a line that their patients prefer capsule endoscopy over other tests.
"The pill was the greatest of all because there's no invasion," said Manspeaker, who has had no intestinal problems since her doctor started treating her several weeks ago.
