The union of drugs and devices offers major breakthroughs in health care
|
|
Back in the mid-1980s, medical device maker Medtronic Inc. (MDT ) discovered a way to improve pacemakers. The devices work by stimulating the heart with electrical impulses. But after being implanted, the electrode that delivers the electric jolts causes the tissue to scar. The device has to deliver a more powerful shock as a result, shortening its life and requiring surgery more often to replace it. So Medtronic scientists hit upon a solution: putting a steroid drug in the electrode. As the drug diffuses from the electrode, it speeds healing and reduces scarring. Thus was born the first major product that combined a drug and an implantable medical device in one package. And from that simple beginning has come a major trend that offers big improvements in health care — assuming that regulatory agencies can keep up with the science. “So many of the new and highly promising technologies are combinations of devices, drugs, and biologics,” says Clifford Goodman, senior scientist at the Lewin Group, a health-care consultant. The most visible example: so-called drug-eluting stents from Johnson & Johnson and other companies. These expected blockbusters are tubelike devices that hold arteries open. They release a drug that helps keep the artery from narrowing again. Once the stents hit the market this year, their use “will be huge,” says Dr. Kevin Browne, cardiologist and chairman for research at the Watson Clinic in Lakeland, Florida. Drug-eluting stents are just the tip of the iceberg. Combinations of drugs and devices are treating Parkinson’s disease, improving damaged lungs, breaking up clots that cause heart attacks or strokes, and building bone to fuse spines (table). Companies are even using tiny needles to inject new muscle-building cells into damaged hearts. And coming soon, scientists expect, will be artificial pancreases for diabetics. By combining glucose monitors, sophisticated algorithms to sense the body’s need for insulin, and implantable insulin-delivery pumps to secrete it exactly when it’s needed, these devices will mimic a real pancreas. Until recently, most medical advances came from better drugs, more sophisticated devices, or improvements in information technology, says Sami Hamade, vice-president for business development at device maker Guidant Corp. (GDT ) But more and more, says Hamade, “true innovation will happen at the intersection of two or more of these areas.” Adds Richard A. Gonzalez, president and COO of Abbott Laboratories’ Medical Products Group (ABT ): “We believe the best way to treat patients with very complex diseases is a combination approach.” Guidant and others are working with wireless companies to create defibrillators linked to the airwaves, for instance. If a device senses an impending problem in a patient’s heart, it can alert a doctor immediately, who can then prescribe medicines — such as a blood-thinning drug — to prevent problems before they occur. “If you imagined a few years ago that I’d be sitting at the same table with the wireless guys, I’d have said you were crazy,” says Hamade. More often, though, the new alliances spawned by the combination products are between medical device companies and pharmaceutical or biotech companies. Abbott is supplying a drug that inhibits cell proliferation — ABT-578 — for Medtronic’s stent. And Guidant has invested in Bioheart Inc., which is trying to fix failing hearts. The idea: Take skeletal muscle cells from a person’s thigh, grow them in a test tube, then put them inside a tiny needle atop a catheter. Doctors insert the catheter into an artery in the groin and thread it up to the heart, where the needle injects the cells directly into the damaged area. So far, more than 15 patients have been treated. Many doctors aren’t waiting for companies to put out combination products, however. They’re busy mixing and matching drugs and devices on their own. At the Lafayette (La.) facility of the Cardiovascular Institute of the South, Dr. David E. Allie has modified a clot-busting water-jet device from Possis Medical Inc. to also deliver a drug. On their own, drugs take hours to dissolve big clots and often cause life-threatening bleeding elsewhere in the body. The Possis device uses a powerful spray to create a suction that vacuums the blockages out in seconds. But it doesn’t work well on older, harder clots. So Allie first uses the device to shoot Genentech’s (DNA ) tenecteplase (TNK) directly into clots blocking leg arteries, which can cause gangrene and require leg amputation if not removed. About 20 minutes later, he uses the device in its normal clot-sucking mode of action to remove the now-softened clump. That quickly restores normal blood flow. “This has decreased the time it takes to revascularize the leg from many hours to minutes,” he says. Doctors hope for similar dramatic results in stroke victims. Scientists once were optimistic that experimental nerve-protecting drugs could limit damage to the brain when clots cut off blood flow. But trials proved disappointing. The reason, researchers realized, is that drugs couldn’t help when the blood flow is still cut off. Clot-busting medications, meanwhile, only work in a minority of patients — and at the risk of deadly bleeding. So companies are developing devices such as miniature corkscrews or catheters equipped with tiny ice-pick-like tips, ultrasound generators, or lasers to break up the clot and help the drugs dissolve the smaller pieces. Ultimately, predicts Dr. Wayne M. Clark, director of the Oregon Stroke Center in Portland, physicians will use “a cocktail approach” for stroke, employing mechanical devices first — perhaps with a small amount of clot-dissolving drug — and then quickly adding nerve-cell protectants to keep the brain as healthy as possible after the injury. The advances brought by this new marriage of technologies, however, could be slowed by regulatory delays, many executives fear. In the past, the Food & Drug Administration has struggled to review combination devices under its existing structure, with separate centers for drugs and devices. The “FDA has taken up to 13 months just to determine which agency center should perform the review, and sometimes routes technologies inappropriately through the approval process,” according to a report by the Lewin Group. To tackle the problem, the industry, Congress, and the FDA worked out an arrangement last year to create a new office of combination products. But “there are still jurisdictional squabbles at the agency about who really regulates this kind of thing,” says Blake Devitt, leader of Ernst & Young’s pharmaceutical industry practice. FDA officials believe that they can meet the challenges involved in regulating these new hybrid therapies — and they must. By all indications, combination therapies are poised to produce remarkable advances for modern medicine. Source : businessweek.com |