Dr. Victor Gurewich, a researcher and Harvard Medical School faculty member since 1965, discovered a breakthrough drug treatment for heart attacks and strokes with the potential to save millions, but institutional resistance and a U.S. healthcare system that puts profits over patients are keeping it out of reach.
Chest tightness. Arm pain. Panic. The warning signs hit hard, and for a moment, the thought of a heart attack is no longer just a fear—it’s happening.
The ambulance tears through the city, and soon you’re in the ER. They give you aspirin, nitroglycerin, and a drug called tPA to try to dissolve the clot. But the doctor’s face darkens. The blockage is severe. You’ll need a PCI – a percutaneous coronary intervention – where a catheter is threaded through your artery, a balloon is inflated to open the blockage, and a stent is placed to keep the artery open.
The problem? Your hospital doesn’t have a catheterization lab—only two-thirds of hospitals do. The PCI should ideally happen within 90 minutes, known as the “door-to-balloon” window. An hour-long transfer to a bigger hospital is in order—and time is slipping away. And what will your insurer allow?
The reality hits: you might not make it.
Every 43 seconds, someone in the United States has a heart attack. Heart disease has been the leading cause of death in the U.S. for 100 years, and too many of us just keep dying. More than one out of ten people who experience the dreadful symptoms of a heart attack will not survive.
Dr. Victor Gurewich is on a mission to change this. He insists that many heart attack deaths could be avoided with the proper drug intervention, but catheterization—the go-to treatment—has major flaws that cause needless death.
Gurewich’s argument boils down to three key points. First, with so many U.S. hospitals lacking cath labs, heart attack victims often face transfers that can lead to delays—delays that can double mortality as blockages persist. Second, catheterization works only on larger vessels, leaving smaller arteries vulnerable. Third, a simple, more effective clot-dissolving drug treatment exists—if only doctors could access and use it. “If you had a heart attack right now, I could treat it by injecting a drug into your vein,” he says. “You’d be more likely to survive.” (This is a hypothetical situation, as the drug does not yet have full FDA approval).
According to Gurewich, his drug therapy mirrors the body’s natural clot-dissolving process, making it a far superior alternative to introducing foreign materials – stents that can cause complications such as allergic reactions, blood clots, scar tissue, and blood vessel collapse. Medication, on the other hand, works on the blood rather than the vessel so it is not limited by vessel size. And since no procedure or special facility is needed, it’s far less costly than catheterization.
“There is evidence that it is effective for strokes, too,” adds Gurewich. “Heart attacks and strokes are essentially the same disease process — clots in different parts of the body.”
He is confident that his treatment, which involves a combination of two agents that replicate the body’s innate mechanism for dissolving unwanted clots, delivers better outcomes than standard protocols – a claim backed up by studies.
Gurewich—an unstoppable force in his field—is challenging medical traditions with relentless determination. At 95, his mind is as sharp as ever, and he has been advocating for his innovative treatment since the 1980s, with no plans to back down.
The story of how an invasive procedure came to be preferred over a potentially superior drug treatment exposes a medical system that too often resists progress and values profits over patient care, sabotaging public health in the name of financial gain.
Fibrinolysis: The Body’s Natural Defense System
Born in Berlin, Gurewich hails from a family with a rich legacy in medicine. His father, Vladimir, was one of Sigmund Freud’s trusted doctors in London, while his uncle, David, attended to none other than Eleanor Roosevelt. Gurewich’s grandfather, David, was a physician, and his grandmother, Maria, was renowned for her unconventional massage techniques, attracting high-profile patients, including Roosevelt.
When the Nazis rose to power, Gurewich’s family fled Germany, first to the U.K. and later to the U.S., where his father built a successful medical practice. He studied medicine at Harvard, where his passion for vascular disease took root. When the Vietnam War started, he got a deferment by serving two years in the Air Force medical service in Florida. By 30, he was named chief of medicine at a military hospital in Tampa after the current chief fell ill, and he started publishing significant work in the New England Journal of Medicine, including a case study of pulmonary bleeding. His career has fused patient care with scientific inquiry, culminating in over 200 published research papers.
After his military service, Gurewich completed his cardiology residency at West Roxbury VA Hospital near Boston. Though officially a cardiologist, his fascination with the vascular system led him to specialize in fibrinolysis— the body’s fascinating natural process that dissolves clots. Early in his career, the death of a young woman from a pulmonary embolism after childbirth haunted him deeply. “Childbirth is a bloody business,” he explains, noting that while he wasn’t the first to discover that clotting factors surge during pregnancy, he may have been the first to see just how critical it is. “The body prepares to stop bleeding, but clotting can also be deadly,” he says. “I wanted to understand it better.”
In other words, clotting is a defense mechanism that can sometimes go too far. While you need blood to flow freely to carry oxygen and nutrients in the body, it has to thicken into clots to stop bleeding when you’re hurt. Once the wound heals, fibrinolysis breaks down the clot, preventing blockages in blood vessels. “Clotting has to happen on the outside of the vessel,” explains Gurewich. “If it’s on the inside, you’ve got a serious problem.”
Clotting is thus both a lifesaver and, if unchecked, a potential killer. In this paradox lies the game-changing insight of Gurewich’s work.
While drugs like heparin (fast-acting, intravenous) and warfarin (slower, oral) had long been used to prevent clots, Gurewich was interested in dissolving them. That’s why he zeroed in on thrombolytics, the class of drugs known as “clot busters” —because once you’ve got a clot, those other medicines won’t help you. He started an anticoagulant clinic to further explore the process, treating patients with clots in the lungs, legs, heart, and brain.
Back in the 1940s, Danish researchers discovered an enzyme that eventually led to the identification of a more specific agent: tissue plasminogen activator (tPA), the first clot-busting drug. The FDA approved tPA for heart attacks in 1987 and for acute ischemic strokes in 1995. Gurewich points out that while tPA became the standard drug treatment, “it was never as effective as we’d hoped—too much of it can cause bleeding.” He notes that from the 1950s to the 1970s, early studies explored other clot busters, but they, too, carried bleeding risks, causing interest in thrombolytics to wane.
Here’s where Gurewich comes in. He could see that tPA’s mechanism made sense but realized it wasn’t the full answer. He likens the use of tPA by itself to putting the key in a car’s ignition: “The starter alone won’t do it; you need the engine,” he says. So, he figured out the solution: combine tPA with something else—the engine—to get the clot-busting process going in just the right way.
Gurewich’s search to identify tPA’s natural partner led him to investigate urokinase, an enzyme that had been known but was first described by him for its complementary role in blood clotting alongside tPA. While urokinase helps break down clots, it doesn’t work well in the bloodstream because of natural inhibitors that block its action. In 1981, he discovered an enzyme in urine that was the “inactive” form of urokinase, which he named pro-urokinase (proUK). He then found that combining proUK with tPA created an even more powerful clot-busting system than urokinase or tPA alone. “Now you’ve got the starter and the engine,” he says.
When tPA was first used to treat heart attacks, large doses of 100 milligrams were common, which could cause dangerous bleeding by targeting hemostatic fibrin and affecting other parts of the body. But Gurewich discovered that combining tPA with proUK allowed for just 5 milligrams of tPA, a safe dose.
In 1995, he worked with an Italian company, FarmItalia, on a small study testing the combination of tPA and proUK in 101 heart attack patients. The results were impressive: 82% in a subset of patients had their blocked artery fully open and just 1% died. In comparison, traditional treatments at the time only showed 45% of patients with the blocked artery fully open and a 6% death rate. “It blew all the other statistics out of the water,” he says. “No treatment has ever matched its efficacy and low mortality, and the study confirmed that only 5 milligrams of tPA were necessary, while also demonstrating that a 90-minute infusion of proUK was optimal.” The findings were published in the prestigious Journal of the American College of Cardiology.
Despite promising results from the Italian trial, progress on his drug therapy stalled. The sale of the firm shortly after the trial shifted priorities—though the company had licensed Gurewich’s treatment, cardiology was no longer a focus after the sale. It was an unfortunate case of bad timing. What could have been a revolutionary breakthrough didn’t happen.
While strong study results often lead to replication, this was not the case with Gurewich’s treatment. Alongside the misfortune surrounding the sale of FarmItalia, Gurewich believes a key factor in the stalling was the medical field’s growing fascination with high-tech procedures, which overshadowed the potential of developing drugs that harness the body’s own natural processes. Like a clot in the mind, once it set, dislodging it became a major challenge.
Despite Gurewich’s discoveries, doctors continued to rely on tPA as the standard drug treatment for breaking up blood clots—it’s still the only drug available on the market. He is frustrated that fibrinolysis still revolves around tPA alone, even though more effective alternatives are available. Partly due to the limited effectiveness of tPA on its own, the medical field has increasingly turned to more invasive procedures as a treatment option. (He recently co-authored a paper in the Journal of Vascular Research outlining his concerns about this direction).
“In a heart attack, blood flow to part of the heart muscle is blocked, so the top priority is restoring circulation as quickly as possible,” Gurewich points out. “Yet, current first-line treatments—such as PCI or the current thrombolytics—are slow, interventional, inpatient procedures. Why is that? Patients with heart attacks seemed to fare better 20 years ago.”
Profits Over Patients
Gurewich believes there’s another reason invasive procedures have become standard: “They offer a big financial incentive,” he says. “Each catheterization is reimbursed around $23,000 in the U.S. – that’s the amount the hospital gets for the procedure.”
While hospitals don’t directly regulate drugs, they have a significant influence on which treatments are used. David Segarnick, a pharmacology professor at Rutgers New Jersey Medical School and advisor to Thrombolytic Science International (TSI)—a biopharmaceutical company co-founded in 2006 by Gurewich to further study his drug treatment—points to what he calls the “PCI Industrial Complex.” This refers to the costly infrastructure built around cath labs, which require expensive equipment, specialized facilities, and skilled staff. To justify these high costs, hospitals often need to perform a high volume of procedures, which can lead to a preference for invasive treatments over less costly, non-invasive alternatives. To make matters worse, the grip of rapacious private equity firms on healthcare is tightening, with many of these shadowy firms now owning hospitals and other medical facilities, laser-focusing on profits, not human life.
In 1996, as more and more heart attack patients were getting stents—or dying—Gurewich developed a drug that combines a more stable version of proUK—mutant prourokinase (mproUK)—with a small dose of tPA. He was hopeful that further study would help convince another drug company to license the medicine and make it available. However, clinical trials are incredibly costly, and his small company could only stretch its resources so far.
Gurewich and Segarnick are currently trying to attract funding from the NIH, venture capital firms, and established pharmaceutical companies to enable TSI to carry out the expensive clinical trials to demonstrate the efficacy of their therapeutic—notwithstanding the skepticism that they face from the “PCI Industrial Complex.” But venture capitalists and Big Pharma might doubt that TSI’s treatment can attract enough interest from stock traders to raise the funds it needs—both while the company is still private and later, during a potential initial public offering (IPO). Without this funding, they may not see the investment as worthwhile.
How could this be, with a drug treatment that could potentially save so many lives? The answer lies in financial incentives that may not align with the public good. When large profit-driven firms invest in a small drug developer, the goal isn’t always to get a drug approved by the FDA. As economist William Lazonick points out, based on his research with Öner Tulum, “When VCs invest in a biopharma company, their payoff is not dependent on whether the startup generates an FDA-approved drug.” He explains that “almost all biopharma IPOs occur without a commercial product” and no matter how effective the drug might be, “the VCs just want enough hype surrounding the startup to rake in as much money for as little equity as possible prior to and through the IPO.”
In other words, generating buzz and making quick profits too often takes priority—whether or not patients get access to getting life-saving medicines.
In Gurewich’s case, the hype around his form of treatment waned as the medical community shifted away from thrombolytics, and the promising 1995 study faded in time. However, one piece of news was encouraging: unrelated research published in The Lancet in 2006 provided indirect support for his concept. In a study involving nearly 100,000 patients, it was found that in 15% of cases, the artery blocked by the heart attack was fully opened, meaning the blood clot had dissolved. This was due to the natural clot-dissolving enzymes, tPA and proUK, present in the blood, which helped break down the clot.
In a nutshell, the patient’s body did the clot-busting job on its own, showing that it’s possible even with the small amounts of enzymes naturally in the body. This gave a great example of how Gurewich’s treatment could work. Some people could actually recover from a heart attack on their own if they have a strong natural ability to break down clots, which really shows how powerful nature’s own system is. He believed that many more patients could benefit if higher, therapeutic levels of these enzymes were used.
But the problem remains that invasive procedures like catheter-based treatments for heart attacks, surgeries, and high-tech interventions can be lucrative for healthcare providers, often overshadowing simpler, cost-effective drug treatments that may be just as effective, if not more so. The financial interests tied to medical devices and procedures create a bias toward these options that can mean more medical costs and greater risks for patients.
Ultimately, consumers and taxpayers foot the bill for heart attack catheterizations because hospitals are reimbursed by insurance companies (private or government-funded), which are paid for through premiums from individuals, employers, and taxes. Patients may also pay part of the cost through co-pays or deductibles, while the uninsured may rely on public programs, with the financial burden ultimately falling on the public.
Gurewich criticizes the incentives of a healthcare system where interventions categorized as “procedures,” no matter how costly, are reimbursed generously, while “treatments,” such as drug injections, are not. He explains, “Even if I injected gold, there’s no reimbursement because an injection isn’t considered a procedure.” He points out that interventional procedures are so popular because they pay well. “I was on the board of a remote cardiac monitoring company,” he says, “and the financial incentives for doctors—based on what they were paid per procedure—were a key part of the strategy.”
He laments that even when a treatment has “clear, compelling health economics,” doctors won’t use it unless there’s a way for them to get paid. A drug injection treatment such as his is potentially inexpensive to manufacture at scale (though drug companies can still inflate the price), doesn’t require specialized facilities, and could be administered by healthcare practitioners other than doctors— all of which could save Americans money.
In his view, the real challenge is the way financial interests are shaping medicine for the worse. “It’s all about money, money, money,” he complains. “Instead of improving fibrinolysis, the medical field abandoned it and replaced it with high-cost procedures.”
He observes that stroke treatment has gone down a similar road. For larger clots, doctors can do surgery to remove them, but it’s not an option for smaller vessels. In those cases, tPA is often used, but it can cause seizures and deadly brain bleeds, making doctors hesitant – nobody wants to be sued for malpractice. Gurewich believes his combo of tPA and proUK would be far more effective at safely dissolving clots: “The safety of my sequential combination was shown in both the 1995 trial for heart attacks and a 2023 trial of dual thrombolytic treatment for stroke.”
Bottom line: America’s profit-driven medical system is a textbook case of market failure—where profits drive decisions, better treatments are ignored, and patient care is sidelined.
Developing Countries Leading the Way?
Gurewich has been encouraged by a phase 1 trial of his treatment in 2017, as well as a phase 2 trial in ischemic stroke. He’s excited about a current heart attack trial of the therapy underway in the U.K. funded by TSI. “It’s a small trial, with just 48 patients, but the results so far are very promising,” he says. He’s confident that in just a year, he’ll have the data to back up his treatment’s success again.
In the meantime, developing countries are turning to Gurewich to help get treatment for patients in a medical landscape where more invasive interventions are simply unaffordable. His company is collaborating with Osman Khalid Waheed, the director of Ferozsons, a pharmaceutical company in Pakistan, on a privately funded trial, hoping that the Pakistani government will eventually adopt his treatment nationwide. “If we can get everything in place,” he says, “they could start in the middle of next year on a trial.”
Gurewich remains hopeful that a U.S. company will help bring his drug therapy to American patients: he’s already cleared a major hurdle—FDA approval for an IND (Investigational New Drug) status. Securing an IND is the first step in bringing a new drug to market, and Gurewich’s application was accepted, which means that the combination of mproKU and tPA can be used to treat people with heart attacks and stroke in a controlled study. The National Heart, Lung & Blood Institute (NHLBI) is also interested in working with TSI to support a larger phase 3 study in heart attack patients. He’s optimistic that these milestones, along with additional data from the U.K. study, will capture the attention of American investors.
Defenders of America’s healthcare system love to tout its “world-class” results, claiming that its high cost is justified by advanced technology and cutting-edge treatments. But here’s the kicker: in some cases, developing countries actually get access to cheaper, simpler, and sometimes even better drug treatments because the U.S. is too busy pushing expensive, invasive procedures. Driven by profit motives, the focus on high-cost interventions often slows down or outright blocks better, life-saving options. Meanwhile, places like Pakistan, where cost-efficiency is key, can leapfrog to adopting straightforward treatments that are far more practical and accessible.
As 800,000 Americans die from heart disease and stroke every year, the U.S. can’t afford to fall further behind.
