Sponsored Insight
By Professor Ian Meredith AM
The earliest and yet most profound lesson I learned from three decades serving and caring for patients as an interventional cardiologist is “primum non nocere” — first, do no harm. Those three words elegantly capture the physician’s primary responsibility and obligation to do the utmost to ensure patient safety while delivering the best possible care. While I no longer care for patients directly, this remains my unwavering commitment in my current role as Global Chief Medical Officer at Boston Scientific.
Another invaluable early lesson, from an astute mentor, is that the way to provide the highest standard of care to patients involves listening carefully, understanding their needs and expectations, and then to engage in balanced, thoughtful, and patient-focused dialogue. It is unfortunate, therefore, that the focus and direction of recent media reports questioning the safety and integrity of the medical device industry may create unnecessary fear and apprehension and discourage patients from having such open and balanced conversations — and that, in turn, could do harm.
The recent coverage of spinal cord stimulators (SCS), which provide a drug-free alternative for long-term pain relief, brings this issue strikingly to light. Treating chronic pain, which afflicts more than 30% of Americans, is often relentless, progressive, and debilitating. It is a complex condition and many patients struggle to escape it. Far too often, opioids and other potentially addictive treatments have compounded patients’ suffering.
While decades of meticulous clinical research and real-world evidence go into documenting the safety and effectiveness of SCS devices to secure approvals from the FDA and other regulatory bodies across the world, recent news reports have misrepresented data and provided selective and incomplete facts. Understanding clinical evidence can be complicated, and patients deserve a fair, reasonable, and balanced perspective of such evidence. It should be explained carefully, logically, and in context.
Innovators, health care providers, and the public know that there are no panaceas and one therapy will never be right for all, but it is important for patients to have options and make informed treatment decisions. Stories of patients who have had difficult experiences are disheartening, but we remain committed to supporting patients and continuing to innovate and improve our therapies. We must also remember the millions of patients who benefit from medical technology.
We can’t eliminate all risk when complex technologies and patient conditions are involved but we can commit to making our devices as safe and effective as possible. At Boston Scientific we have a strong safety record, with an average annual complaint rate across our entire product range of less than 0.15% and an even lower rate of adverse events. We’ll never stop trying to improve.
There are mountains of available data about medical devices and the risks associated with any implant, accompanied by anecdotal information. We welcome meaningful dialogue, and we must seek to understand and communicate the nuance in this expanse of information. Just as we would not condone false hope for a patient not medically suited for an implant, fear and skewed interpretations of data should never stop patients from getting appropriate and indicated care.
Fulfilling the obligation to “first do no harm” includes encouraging patients in need to engage in thoughtful, balanced, patient-centric conversations, rather than callously frightening them away from important therapeutic innovations that can give them real hope—and real relief.
Read more here about Boston Scientific’s commitment to safe and effective medical devices.
Professor Ian Meredith AM is Executive Vice President and Global Chief Medical Officer of Boston Scientific Corporation.