PATIENTS WILL DEMAND BETTER, FASTER
DIAGNOSES AND TREATMENTS, DOCS SAY

By Tom Henderson
Small Times Senior Writer

COLUMBUS, Ohio, Sept. 26, 2001 — The driving force that will propel small tech into the medical marketplace won’t be the devices, themselves, or the science behind them.

It will be a better informed and much more demanding patient who won’t put up with the traditional

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“All I’m doing is
creating fancy
plumbing. I need
your help. We
need to identify
the genes that
lead to heart
disease.”
Dr. Robert Michler
heart surgeon
level of medical mistakes, engineers and scientists were told Tuesday on the concluding day of BioMEMS and Biomedical Nanotechnology World 2001.

Delivering the message was a doctor, himself, Dr. Fred Sanfilippo, senior vice president of health sciences and dean of the College of Medicine and Public Health at Ohio State University.

“These devices are going to change the way we assess disease and the way we deliver medicine,” he said. “And they are going to put much more of the assessment, diagnosis and treatment in the hands of the patient.”

A health-care industry resistant to change will be driven to accept the disruptive technologies of small tech by an informed patient base, he said.

“I share your concern about the medical profession changing in a timely manner,” he told an audience member who had risen to assert that the medical establishment is reluctant to adjust to new technology.

“One difference now is the ability to disseminate information to the patient. One example are the patients on the Web, moving from one institution to another to learn all they can,” he said.

“The difference is consumerism. You better believe the patients, and their families, have access to this information on the Web. Patients are going to drive this. That’s the big difference. You see it over and over again. Ask any doctor. Patients are coming to the office armed with more information than ever before.”

They are more knowledgeable, asking questions, better aware of medical advances and more demanding, he said, and they won’t continue to tolerate unreasonable delays and errors.

Now, health assessment requires laboratory tests, often off-site and at a delay of hours or days. BioMEMS sensors and such emerging tools as labs-on-a-chip will not only give those assessments in real time, he said, but they will take much of it out of out of doctors’ hands and into the hands of patients.

Just as diabetics can now monitor their glucose levels at home, other patients will be able to use biosensors to diagnose themselves — more accurately and at a lower price.

The very clear results that biosensors deliver will also take much of the current guesswork out of deciding on a course of treatment, he said. And the sensors will guide therapy as it goes along — in real time, at the patient’s house, with smart small tech devices that are able to constantly adjust drug delivery to maximize results.

As for error, Sanfilippo used cancer as an example. “The biopsy as the gold standard is worrisome, because it is so subjective,” he said. “It’s looking at tissue prepared in the most sub-optimal way.

“We need real-time assessment. Is this cancer or benign? Is it a tumor or a reaction process? Is this disease A or disease B?”

Biosensors will provide those answers, he said.

Sanfilippo told of a study, published when he was at Johns Hopkins, of the autopsy records of 1,105 patients from 1986-1995, 250 of whom had cancer. Fully 111 of those cancers had been misdiagnosed or undiagnosed during treatment for various symptoms. In 57 of the patients, cancer was the immediate cause of death.

“The fact that you can misdiagnose cancer or miss it altogether tends to wake people up,” he said. “That’s an error rate of 44 percent. And a 40 percent error rate is consistent in cancer studies throughout the 20th century. There’s a huge opportunity to improve health care if we focus on disease assessment.”

Five percent of health-care expenditure in the United States is on disease assessment, he said. The outcome of that assessment drives intervention and direct treatment, which represents 70 percent of health-care expenditures.

Developing micro and nanotechnology tools may substantially increase the front-end cost, he said, but the resulting improvement in assessment would be leveraged into far greater cost savings on the back end.

“The added cost of technology really pays off in terms of the cost of patient care,” he said.

But more important than cost is the improvement in health care that small tech diagnostic tools such as labs-on-a-chip, implantable sensors to monitor disease and micro and nano drug-delivery devices will bring patients, he said.

Sanfilippo told of another study done when he was at Johns Hopkins of men who had been diagnosed elsewhere with prostate cancer and who were scheduled there for surgery. The study found that 2 percent did not have the disease.

“The cost for the additional tests to determine that they didn’t have cancer was about one-tenth the cost of the savings, so better diagnosis is a tremendous lever,” he said.

In other studies, 1.5 percent of women diagnosed with breast cancer didn’t have it, and three percent of skin-cancer diagnoses were false positives. “That may not seem very high, but the costs are enormous,” he said.

“As the technology evolves, patients will have data and the ability to translate those data into decisions. That’s not something we doctors should be afraid of. It’s something we should appreciate.”

SMALL TECH WITH HEART

Dr. Robert Michler, a heart surgeon and professor at Ohio State, followed Sanfilippo by asking the audience “to focus some of your unique talents into cardiac disease.”

He said that cardiovascular disease is the top killer of men and women in the United States, accounting for more deaths than the next seven causes combined — one death every 33 seconds.

“And the most common symptom isn’t angina, it’s death,” he said.

The cost in health care in the United States, alone, is $286 billion a year.

Michler showed the audience dramatic films of a new robotic surgery device at Ohio State, the first to be approved by the U.S. Food and Drug Administration. It allows physicians to perform minimally invasive heart surgery, using robotic arms that enter the chest cavity through small incisions and do the most delicate of procedures.

He said sensors and small tech monitors could do what can’t be done now — giving him biofeedback, for example, on whether an area of the heart was beginning to receive a blood supply.

Better yet, small tech devices would be able to assess plaque buildup in coronary arteries, even point out which patients will likely develop heart disease before they do or before they become symptomatic.

“We need to treat the underlying disease. You saw the incredible machinery we have. And I’m amazed every time I hold a heart in my hands. But all I’m doing is creating fancy plumbing. I need your help. We need to identify the genes that lead to heart disease. We need stem cells to rejuvenate cardiac tissue and blood vessels. We need laser revascularization.

“And there are huge nanotech opportunities, too. We need vehicles to transport muscle cells and blood-vessel cells, to deliver blood-clotting drugs. We need nanopore biologic valves that will sense something in the body and be stimulated to open, release their contents and close.

“Traditional heart surgery is here to stay, but there is going to be an intense area of exploration in bioengineering to make it easier for the patient and the surgeon. Can we go beyond the palliative? Can we do more than just create fancy plumbing? I think so, because of the capabilities in this room.”


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CONTACT THE AUTHOR:
Tom Henderson at [email protected] or call 734-528-6292.

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