Did hundreds of patients at St. Joseph Medical Center get heart stents when they weren't called for under accepted medical standards?
That's a disturbing question. But for taxpayers, insurers and most medical consumers, it pales next to this one: Are millions of patients getting stents that are unnecessary even when the rules give doctors a green light?
Accumulating evidence says the answer is yes.
"In many instances we're seeing it overused and in some instances abused," says Dr. William E. Boden, a professor at the University at Buffalo Schools of Medicine & Public Health who led a major study on stent effectiveness. "Surgeons and hospitals get reimbursed handsomely for doing procedures."
Don't let the situation at St. Joseph, where patients received stents when they might have had only slightly blocked arteries, obscure the big picture. Most people getting stents don't need them even if scans show substantial blockage, studies suggest. Stents can be dangerous, too.
"You're trading one disease for another - the disease of having a blockage for the disease of having a metallic stent in your heart. And that is a disease, make no mistake," says Dr. Michael Ozner, medical director of the Cardiovascular Prevention Institute of South Florida. "These procedures are not without risk."
Thanks to extraordinary promotion and advertising, stents have become a multibillion-dollar business, substantially contributing to soaring medical-insurance costs and federal deficits. They're a perfect illustration of why American health care costs more but delivers less.
The popularity of the tiny tubes, intended to prop open clogged heart vessels, took off when companies began coating them with drugs to prevent arteries from reclogging. But the coated versions cost as much as three times more than bare-metal stents.
Dr. Mark Midei, the surgeon associated with the implants questioned by Towson-based St. Joseph, was an early proponent.
"This is the hottest thing in cardiology in years," he told The Sun in 2003, referring to the drug-coated Cypher stent made by Johnson & Johnson's Cordis division.
Cordis turned up the buzz with an expensive TV-ad campaign for Cypher that ran nationwide in 2007 but also aired exclusively in Baltimore in early 2008.
Health-policy professionals were used to companies hawking pills directly to patients. Even so, J&J's "Life Wide Open" stent commercial shocked them because it expanded the pitch to medical hardware.
Baltimore "was apparently a key market for Cordis at the time, given the proximity of a lot of hospitals in that region," said J&J spokeswoman Carol Goodrich.
Boy, was it. Last fiscal year, Maryland hospitals did $222 million in stent-related business, a two-thirds increase from fiscal 2002, just before the launch of the coated stents, according to the Health Services Cost Review Commission. And that doesn't count doctor charges.
Stent business at St. Joseph jumped even higher, going from $22 million to $38 million in the same period, the commission says.
Competition for stent spoils helped set off a bitter split at MidAtlantic Cardiovascular Associates, a big Baltimore cardiology practice. It also prompted a federal investigation that preceded the revelation of alleged clinical irregularities at St. Joseph.
Did patients benefit as much as the medical industry? Nobody suggests stents don't save lives when somebody is having a heart attack. But Boden's study and others show little benefit and lots of risk for patients with partly-blocked vessels who aren't in cardiac distress, doctors say. That's most stent cases.
"There has never been a study showing that people who are stable who get stents live one day longer or have fewer heart attacks" than patients with similarly blocked arteries who don't, said Ozner, author of "The Great American Heart Hoax."
In fact, medicine is revisiting the whole Roto-Rooter model that assumes vessel blockage is the main predictor of a heart attack. The worse culprits are often inflammation and smaller plaques that break off and cause clots.
Numerous patients getting stents would be better off exercising, changing diet, losing weight and taking appropriate drugs, says Boden. That way they won't risk the surgical complications of implants and, in the case of coated stents, won't have to take blood thinners for years.
But nobody makes money giving patients sensible and conservative advice.