How far will you go to promote your medical invention? This is a question for clinical innovators. How far will you go to market the invention? This is a question for corporations whose primary purpose is to keep pleasing their shareholders. The limits of promotion, of course, should be reached when the balance of benefits and harms is no longer favourable. That balance is a judgment, made by people capable of deciphering the evidence and seeking to protect the public—drug and device regulators, for example.
What happens when an intervention seems innocuous, the data are equivocal, and the benefits are more theoretical than demonstrable? Again, it depends. There is no free good; every intervention is a vector of harm—trivial, minor, major, or yet to be determined. It is in these grey areas, where judgment is required, that the peddlers of a new product show their true colours and the vigilance of regulators is needed. A company will see the financial potential in a product it has invested in. An inventor will see the success in their idea—and often, too, the possibility of financial reward. But it’s hard to see what benefit a regulatory authority can achieve from misleading the public; of failing to do the exact job it’s meant to do.
Interestingly, it can be the case that every actor means well. The inventor is genuinely convinced of the benefits of their invention. The company has faith in the data that it has generated, analysed, and summarised—through investment—to support regulatory approval of its product. The regulator seeks to approve a product that will solve a problem. The thinking goes: if we can help people, if we can make them better, if we can prevent an illness or injury—let’s get it done.
The story of Q-Collar (doi:10.1136/bmj.r2028)—a device that applies pressure on the jugular vein and is claimed to cushion head injuries in sport by retaining more blood around the brain—is one of ambition and hope that preventing concussion and long term head injuries in sportspeople (namely, American football players) can be realised.12 We know that both short and long term injuries across a range of sports in players of all ages, particularly children, are an increasing concern. However, the hope in this case is false.
Evidence is building about the detrimental impact of head injuries in sport. Many different sports are affected. Rugby and American football involve head-to-head collisions. Association football has adopted new concussion protocols for immediate management, but worries are growing about the long term impact of repeated head injuries and the effect of heading a football. Cricket introduced helmets for batters in the 1970s, but the head remains a target, and the optimal helmet design remains a challenge. Medical organisations have a history of calling for bans on boxing, where the objective—whether the boxing world acknowledges this or not—is to inflict a brain injury on your opponent.
Duty of care
You might argue that sportspeople are willing participants. Yet why should they be deceived in the course of creating “entertainment”? The world of medical regulation owes all sportspeople—young or old, professional or amateur—a duty of care. It’s a duty that the nexus of inventors, companies, and regulators seem to be taking too lightly.
In the case of Q-Collar, our new investigation reveals data irregularities in some of the studies that supported the device’s approval by the US Food and Drug Administration (FDA). Even then, the mechanism of action of the product and evidence of its benefits are more hypothetical than real. Is this how athletes should be treated? Should they be given reassurance that they’re protected from head injury when that isn’t the case? Putting aside the responsibilities of the company and the inventors of the product, at the very least the regulator, the FDA, has a duty of care to the athletes and therefore the public. It’s a duty of care that the FDA failed to provide in its approval of Q-Collar—a decision that must be revisited.
The new regime under Robert F Kennedy Jr is built partly on its strong messaging around reform of regulatory approval in the US. Well, the message to the US secretary of health and human affairs is this: walk the talk of best practice—and don’t ignore medical devices and technology, where processes seem less stringent than for drugs. It’s a familiar message that continues to be delivered to the FDA and other influential regulatory authorities. Why don’t they listen?
