Can FDA Really Ensure Drug Safety? An interview with Harvard Medical School professor Jerry Avorn

Coming right after news that most drug companies haven't even begun the post-approval studies that they had promised to begin, this video interview*, on Bloomberg's "Money and Politics" , with Dr. Jerry Avorn, Harvard Medical School professor and author of the book, "Powerful Medicine," discusses FDA resources, politics and the difficulty the Agency currently has in ensuring drug safety. He believes that there are other "Vioxx" cases out there, waiting to happen. (Please note: there are brief pauses between clip segments, and the end has been cut off (what was lost was the final sentence, that "FDA doesn't have the tools it needs right now")

BLOOM (BLOOM), National

Fri 2 Feb 2007 06:42 PM EDT

For a very different look at Dr. Avorn, The Village Voice ran an interesting article on him(a "father/son" piece that discusses  Dr. Avorn's college career at Columbia University) recently. *For a  rough transcript of the videotaped interview (it is not 100% complete ), read below: Bloomberg Money and Politics, February 2, 2007 Bloomberg:  In September, the Institute of Medicine offered a disturbing picture of drug safety and said that FDA lacked the tools and organization to protect consumers' health. FDA is  addressing these issues and says that the Agency is looking at the drugs 18 months after they hit the market. But legislation was proposed yesterday for new drug safety measures, so we ask, "Are the changes necessary and do they go far enough?" Joining me from Harvard University Medical School, Dr. Jerry Avorn, author of a new book. Thank you for joining us. Does this week's announcement go far enough to address the concerns in your opinion? JA - Not really. It's a nice try for a starter, but it doesn't get to the root of the issues in the report and that many of us have worried about for years. Bloomberg: Sir, what are those concerns? JA - It all comes down to the name of your program, "money and politics," and we won't have the time to get the work done that the patients need. And the politics piece, the regulatory agencies didn't have the clout for that and it ends at the point of approving the drug unless they want to get the drug off the market. There will have to be action taken in Congress to give the FDA more power to get the companies to do what they need them to do. Bloomberg: Doctor, we have a report that says that Congress is investigating that the FDA is improperly looking at the food supply. A  letter written on January 29 and released yesterday reads, in part, "Annual outbreaks of food illness have grown from 40 in 1989 to hundreds in later years..."  JA. That's beyond my area of expertise but what I know from the drug side is that FDA is having a hard time doing safety surveillance of drugs, and whether that carries over to food is beyond my expertise. Bloomberg - In your opinion, are there the safety features in place so that a situation like Vioxx won't happen again? JA - No, very little has changed. Recall Dr. David Graham's statement that he  was not comfortable that the FDA could protect the public from situations like Vioxx recurring. There were good intentions but those are not enough. Bloomberg - And there is criticism that you are aware of on capitol hill saying that FDA is becoming too cozy with drug companies. Would you agree, and what impact does that have on drug safety? JA - Many of us are worried that the FDA is not using the dollars [from user fees] to pay for the salaries and would like to see those dollars to be used on safety.  That's a problem within the Agency and they need to deploy their manpower to look at the problems rather than focusing on the approvals. Bloomberg - I am sure you aware that two of three companies are not getting the safety testing complete, who is to blame for that? JA - That's the problem, the FDA will approve the drug and say "You need to look in these safety problems before you approve the drug," and every year they report on how many of these studies get done and often it's between 50 and 70 percent of them haven't been started in their active files. That's worrisome and that trend hasn't gotten better, and  the FDA didn't have any other recourse but to take the drug off the market...if they don't have the data they need, they can't do that.  We need to do more balancing, but that usually won't be done by the drug developing company, which  tell us about the benefits of the new drug.  That's why we need a regulatory agency and now the FDA doesn't have the tools that it needs to do a better job. Bloomberg - May I ask about your book, Powerful Medicines, and the cost of prescription drugs. Please ell me a bit about that. JA - That was an attempt to look at how we, as a society, doctors and patients. look at drugs and how we have to to balance the risks and costs. We have the benefits but  we sometimes lose track of the risks and costs. It's an attempt to look at those issues and examine results of studies at harvard...there are three sides that must be examined... The fda would like to do a better job but they don't have the tools to do it better. we need to measure and look at each sides than to have the most publicized product to rise to the surface. and we need to do more balancing and that won't be done by the company and they tell us about the benefits and that's why we need a regulatory agency and now the fda doesn't have those tools.