When it comes to an Ischemic stroke—one that occurs when a blood clot blocks a vessel carrying blood to the brain—time is of the essence. Often medical staff have just hours to act or the blockage can cause serious, irreparable damage to brain cells. In fact, for years E.R. doctors have lived by the saying “time lost is brain lost”—referring to the concept that fast and efficient care is paramount to a positive outcome.
It is this life-threatening limitation that some doctors feel was adequately addressed decades ago with the release of a clot-busting drug called tissue plasminogen activator, or tPA for short. The only FDA-approved treatment for ischemic strokes and capable of quickly opening an impaired vessel to prevent most brain injury, it is viewed by many worldwide to be the gold standard of care for those suffering from certain types of strokes. First introduced in the 1980s, it has been subjected to numerous large-scale, high-quality clinical trials that have shown promising results—yet there still exists doubt and reluctance within the medical community regarding its efficacy and safety as a treatment.
For many who have been directly involved in the use and testing of the drug, such fears are unwarranted and potentially harming patients who might otherwise be saved from the devastating effects of a stroke.
Dr. Christopher Lewandowski was one of the principal investigators at the Henry Ford Health System in Detroit during a federally sponsored trial for tPA over 22 years ago, and he was amazed by the results of the testing. As much as 30 percent of stroke victims who arrive at a hospital within a 3-hour window are perfect candidates for the treatment, yet recent numbers show that only about 4.2 percent of them actually do, or just over 35,000 patients out of 844,000 stroke victims according to a 2015 study by University of Michigan Medical School. At the time of the Detroit trial, Dr. Lewandowski published, “We felt the data was so strong, we didn’t have to explain it”—yet, decades later, he’s still fighting an uphill battle.
Opponents to the treatment tend to cite that the conducted studies were flawed, or that clot-busting ability can lead to hemorrhaging in the brain. Worse, many convey such unfounded views to medical students and residents. Dr. Charles R. Wira III is a professor of emergency medicine at Yale, and he often deals with such misinformation firsthand—claiming that many younger physicians get their opinions from blogs and podcasts rather than medical journals or practice guidelines. Worse still, Dr. Wira often has to deal with stroke patients being transferred from community hospitals where the effective timeframe has been squandered. At that point, it’s simply a missed opportunity, but the doctor might not tell you or your family about it. “We try not to raise issues that may lead to litigation,” explains Dr. Wira.
Think such scenarios only happen to the uninformed or the underprivileged? Think again. Approximately 10 years ago, Dr. Lewandowski’s own father suffered a stroke. He told his mother to make the family’s wish clear that her husband receive the clot-busting drug as they were well within the time window—but the E.R. doctor refused because he didn’t “believe in the drug.” Lewandowski immediately drove 400 miles to help, but time had been lost and his father ended up with partial paralysis. “It was very difficult for me personally,” he reflected, “I had spent so much of my professional life working on this treatment. I felt like I had let my dad down.”
So how is it that such a major opportunity to improve emergency stroke care has been passed over for decades? Or why is it that so few patients or their families are even offered the option, allowing them to make the decision as to what care they receive? It is possible that the issue lies not with the drug or the results of its clinical trials, but with the medical community’s attitude toward new treatment options and continuing education. Regardless of the reason, such roadblocks to progress are unfortunate—because ultimately it’s the patient who suffers.
Both an Emory School of Law graduate and MBA graduate of Goizueta Business School at Emory, Chris Nace focuses his practice on areas of medical malpractice, drug and product liability, motor vehicle accidents, wrongful death, employment discrimination and other negligence and personal injury matters.