Research and Responsibility

Question: A friend of mine from high school is in medical school right now. I’m thrilled that she’s following her dream and is going to become a doctor. Recently, though, we can’t get through a round of drinks together without talking about healthcare, politics, and law. That wouldn’t be such a big deal if my dad wasn’t a lawyer. My friend is no fan of lawyers, and she thinks that malpractice law and healthcare regulation are excessive. She says this drives up the cost of healthcare for everyone and unfairly punishes doctors and researchers who are trying to develop and deliver better care. I’m not sure she’s right (or even if I care!), but it’s really coming between us. Help!

Answer: You and your friends aren’t the only ones debating the role of regulation in healthcare–it’s a common discussion among industry insiders, attorneys, and lawmakers. Let’s take a look at the roots and realities of the debate, so that you can decide for yourself what you believe.

Regulation of medicine in the United States is the job of the FDA–the Food and Drug Administration, which has been around since 1906 (though not under its current name). The idea, of course, is to protect consumers. Medicines rushed to market could be dangerous, and if their producers were allowed to make untrue claims, consumers could be taken advantage of. So the FDA doesn’t make it easy to get a drug approved. Between research and the approval process, drug companies estimate that it takes $2.6 billion to bring a drug to market. Other observers disagree, pegging the figure at more like $800 million. Still, that’s far from cheap, and you can see the outlines of the debate emerging already: nobody wants consumers at risk, but everyone wants drug companies to develop life-saving medicines, and they therefore want it to make financial sense to do so. This debate also extends into issues like medical patents.

Similar debates exist in the medical device industry, say the medical device consultants at Global Regulatory Partners. Regulations are so dense and complex that lawyers and consultants are must-have allies for medical companies. Companies that make devices, machines, and fixtures designed the help the sick, injured, and elderly have a responsibility to make sure their products are safe and effective, say the experts behind American Standard’s handicap tubs. Again, of course, the question is whether these regulations are–as your friend suggests–slowing down progress.

The reality is that this is a debate that won’t be solved by you and your friend over drinks. Rather than let the issue ruin your friendship, you may both be better off not discussing this–especially since your friend seems unwilling or unable to avoid expressing distaste for your father’s line of work. Perhaps you’ve already hinted that you’re not enjoying these conversations, but maybe it’s time for a more direct conversation. It’s okay to avoid some subjects with some friends, so don’t be afraid to set boundaries with your friend!

“Time spent arguing is, oddly enough, almost never wasted.” — Christopher Hitchens