GAO Finds No Follow-Up on Some Fast-Tracked Drugs
PHILLIPS: Well, you trust them to protect your health, but is the FDA failing you? A new government study now showing that the FDA did not pull certain drugs, touted to fight cancer, HIV and others diseases, off the market, even after they didn't live up to their claims. Among those drugs investigated: ProAmatine for treating low blood pressure. Also, Iressa, to shrink lung cancer tumors. Marcia Crosse put out the report. She's the director of health care for the Government Accountability Office in Washington, D.C. And Marcia Crosse, let me just play devil's advocate for a second. Let's say -- actually, when I first read about this, read about the report, I was outraged, thinking, oh, my God, if I had one of these life-threatening diseases or illnesses and I was taking a drug that apparently there was no follow-up on and I could be taking it for nothing, that really upset me. But at the same time, you know, I tried to put myself in the shoes of, say, an HIV patient, and say this drug had a 1 percent chance of saving my life, and there wasn't a follow-up report, heck, I'd be -- you know, it would be worth taking the gamble for me.</s>MARCIA CROSSE, DIRECTOR, HEALTH CARE, GOVERNMENT ACCOUNTABILITY OFFICE: Well, I think the concern we have is there are a small number of drugs that FDA either has waited a very long time to get the evidence of effectiveness or has obtained evidence that's shown that the drug isn't effective, and yet has not followed up with the kind of actions that their own regulations say they would take. So, the vast majority of the drugs that have gone through this process for accelerated approval to get on to the market more quickly to treat serious or life-threatening conditions, those manufacturers have gone on to conduct the studies. We did have concerns that FDA wasn't tracking what was happening with those studies. But the biggest concern we had was when there was a lack of evidence or negative evidence and FDA didn't act.</s>PHILLIPS: So, did the FDA fail us? Should there have been more enforcement, more follow-up on the studies of these drugs in the accelerated program?</s>CROSSE: Well, we certainly think there should have been more follow-up. FDA itself wasn't aware of the status of many of the studies that it had required as a condition of approval of these drugs. They have been taking steps to clean up their process for tracking the study status, and so they have better information right now about where those studies stand, but we did find some instances where the manufacturers had failed to conduct the studies and FDA hadn't done anything about it.</s>PHILLIPS: Now see, here comes the outrage part. OK, let's say I am an HIV patient, and I've been taking this drug, but the FDA, I feel like the FDA failed me, and there was no follow-up, and I'm taking a drug that really has done nothing for me. Did I miss out possibly on a drug that could have saved my life?</s>CROSSE: Well, we don't have any evidence of that, and we weren't looking at individual patients. HIV patients were not patients for the particular drugs we saw that were of concern.</s>PHILLIPS: What about lung cancer? What about diabetes? What about cardiovascular disease, all the other things that were listed in your report?</s>CROSSE: We have concerns about how well FDA was overseeing those follow-up studies to know the status, particularly the non-small cell lung cancer patients, which is a small group of lung cancer patients. Those patients had been receiving this particular drug Iressa that when the follow-up studies were conducted, they were shown -- the drug was shown not to be effective in extending patients' survival. And there are now other treatments available. But FDA did take some action. They limited the drug so that no new patients could be given that drug, but they did allow doctors to continue prescribing that drug for patients who had already been put on that medication.</s>PHILLIPS: OK, so let's take Iressa for example. And by the way, the FDA says that millions of patients with serious or life- threatening illnesses have had earlier access to new, safe and effective treatments, thanks to this program, so of course, the FDA is standing by this program right now of the accelerated drugs. But let's take Iressa, since you brought it up, as an example, that's supposed to shrink lung cancer tumors. Finding out what you did, and you found out that really it wasn't doing what it was supposed to do. Should drugs like that be taken off the market?</s>CROSSE: Well, I think FDA needs to clarify when they will take a drug off the market. If that drug had come in under the traditional approval process, not under this accelerated process, the kind of evidence that they later obtained would have been such that the drug would not have been approved to go onto the market in the first place. We are not taking issue with the idea of the accelerated approval process. There certainly is substantial reason for FDA to allow certain drugs, as I said, to treat serious and life-threatening conditions like HIV or cancer to get onto the market quicker, and they do require that the manufacturers conduct these post-market studies, though, to follow up, to obtain the same kind of evidence that they otherwise would have had to obtain to go through the traditional approval process. Our concern is that they weren't tracking the status of what was happening with those required follow-up studies, and that when the follow-up studies weren't being completed or were showing negative information, FDA wasn't doing anything about it. That's where we have a concern.</s>PHILLIPS: Understandably. And we depend on the FDA to be in touch with that kind of information because it's an issue of life or death. Marcia Crosse, interesting report. Sure appreciate your time.</s>CROSSE: Thank you.</s>PHILLIPS: So, as a consumer, how can you tell if there is a problem with the medicine that you are taking? Our senior medical correspondent Elizabeth Cohen here with some help. I think that was one of the things we wanted to know, Elizabeth. Let's say we're told that a certain drug is good for us. Is there any way to track it and see what its success rate has been or if there has been follow-up to the drug?</s>COHEN: Well, I'll tell you, Kyra, after hearing the segment that you just did, I bet people are wondering, how do I know? Maybe I'm taking one of those drugs that the FDA approved quickly and then didn't follow up to make sure that it really worked and was safe. So, we've given you a link on the NEWSROOM blog for how to find the GAO report. You can look your drug up here and see if it's in this group that you were just discussing. Now, the issue, though, is that it's not just these fast-track drugs that are a potential problem here. So, there are other drugs, too. So, the FDA Web site has an alphabetical list of drugs. You can look it up very easily, and they'll tell you about side effects. Anything with a red star -- you can see one there, see one there -- means that there's been some kind of a safety alert. And as you can see, there's quite a few red stars. Another way, Kyra, to try to figure this out is on the FDA Web site. There's something called MedWatch. And MedWatch is a tracking system for problems with drugs. And you can type the name of your drug in and see if it's there. Now, Kyra, I know I've just given you three different Web sites. Obviously, no one's going to remember exactly where all of these are. If you go to the NEWSROOM blog, you can see links to all these sites.</s>PHILLIPS: There we go. That's easy enough, NEWSROOM blog. Elizabeth Cohen, sure appreciate it.</s>COHEN: Thanks.</s>PHILLIPS: And are any of the medicines that you're taking on the GAO's report? Well, you can find out about that also. Just go to my Web page, CNN.com/kyra. We've actually got a link to the full list and the full report. You can check it out for yourself. From culture clash to car crash? A young woman's in the hospital, and her father is nowhere to be found, a week after he allegedly took the wheel and ran her down.