It's been 50 years since a scare over a popular drug first led to tighter controls over drug safety. The drug thalidomide was given to pregnant woman as a sedative and for morning sickness. The drug, which was never released in the United States, caused babies to be born with deformed and shortened limbs.
Dr. Jon Hallberg, MPR's regular medical analyst, said there are important lessons to be learned from the thalidomide tragedy. Hallberg is a physician in family medicine at the University of Minnesota and director of the Mill City Clinic. He discussed drug safety with MPR's Tom Crann this week.
An edited transcript of that discussion is below.
Tom Crann: Jon, what got you thinking about this issue?
Dr. Jon Hallberg: Well, what prompted it was there's an article in this week's New England Journal of Medicine about drug safety and reflecting on the fact that it's been 50 years since legislation went into place putting tighter control on things. And I'm always reflecting about new medications and things I've been very excited about and later have sort of regretted that I jumped on the bandwagon.
Crann: What did that thalidomide drug scare actually bring about at the time?
Hallberg: There was some legislation that had been proposed, and they thought it was dead in the water. It was asking for, frankly, tighter government control because at the time, physicians had to decide if a drug was safe for their patients ... The FDA did not have the authority to say is a drug safe and ready to be released to the market.
Crann: Let's say a new drug comes out. It's been through its trial. Now it's being prescribed to the general public. How cautious are you then in starting to prescribe that?
Hallberg: Personally, I'm very cautious. I can't say that I don't prescribe new medications, but I almost don't prescribe them. I really try not to be swayed by advertising. I'm just cautious. I think doing this for 15, 16 years, I've had enough cases of drugs that I was pretty excited about, only to realize that there are some unacceptable side effects. It's very expensive. People might get drug samples for something, free samples, and then now they're stuck with the bill, and so I don't do samples here.
So I kind of tend to sit back, watch what happens. I'll work with my cardiology colleagues, let's say, or my endocrinology colleagues with a new drug and then see what unfolds.
Crann: You see all kinds of things advertised, some perhaps more reputable and some not, all sorts of supplements. They sometimes have a warning, like, "This is not approved by the FDA." There's no approval on things like that, right?
Hallberg: No. Any dietary or nutritional supplements are sort of exempt from that kind of scrutiny. Now that's changing a little bit in the sense that now that those drugs are on the market, the FDA is starting to look at them, especially the ones that make claims, like, 'You can lose weight with this drug.'
We're not talking about a calcium pill or Vitamin D. Those things are safe, by and large, but the things that make claims that sound a little bit too much, I look at those with great caution. And they're discovering that many of them are contaminated with things that are actually prescription medications that shouldn't be in there.
Crann: What about all of the marketing? You just can't escape prescription drug advertising. So it's a very competitive field out there. Even with the FDA approval process, do you think there's a rush to get things on the market and get them out there?
Hallberg: I think there's even more and more rush to do that, and not just with drugs, but with medical devices as well. If you're a patient suffering from a particular condition and you really feel that there's a chance that this new drug or this new device might help you, you want that thing to be fast-tracked. And so of course there's the pressure to sort of overlook some things, but I think we have to hope that there are checks and balances in place that keep it held until we really feel that it is safe.
Crann: And then what would you say to patients who see on the evening news the new miracle drug for them and they're supposed to ask their doctor if it's right for them?
Hallberg: And they do every day. I'm sure that when I'm in clinic today, in fact, I know that I'll have people ask me that very question. I'm always cautious ... I'll tell them that first of all this is probably not going to be covered by your insurance. I don't have a free sample to give. I tell them that I tend to take a wait and see approach.
I've said this before, but I really think we're kind of in a golden age of generic medication right now. Virtually every category of drug has a generic equivalent now that is tried and true, it's been on the market for a long time, not that they're completely free of any side effects either, but at least we know what those side effects are.
Crann: Because there's been time.
Hallberg: There's been time.
(Interview edited and transcribed by MPR reporter Madeleine Baran)