tag:blogger.com,1999:blog-8550428.post115901577827770823..comments2024-03-28T13:38:36.788-04:00Comments on Pharma Marketing Blog: IOM Report Calls for DTC MoratoriumVladhttp://www.blogger.com/profile/04114063498108633047noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-8550428.post-1159404252544304862006-09-27T20:44:00.000-04:002006-09-27T20:44:00.000-04:00So how much should the industry have to spend to g...So how much should the industry have to spend to get to that 0.3% rate? Remember, some of these recalls are due to rare but serious events, that just aren't going to be picked up in current Phase III trials. To catch those events, you would have to dramatically increase the size and possibly length of the trials, with attendant increase in cost. At some point, companies will pull the plug on those products.<BR/><BR/>As the IOM report suggests, we could do better with vigorous Phase IV and adverse events programs with REAL enforcement authority, not the lack of company follow-through we now get. Rare events should then be quickly noticed as the number of patients increases with adoption; noticed, that is, by someone other than the manufacturer with their revenue and profits on the line. We've seen how eager they are to report in those cases...Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-1159288348648374892006-09-26T12:32:00.000-04:002006-09-26T12:32:00.000-04:00The initial public response by Nearly-FDA-Commissi...The initial public response by Nearly-FDA-Commissioner von Eschenblocked (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01461.html) concludes with an affirmation of the FDA's role relative to the public: "This is more than just a contract with the public to provide a list of services or regulatory functions but rather it is a covenant with the patients and the people we serve to protect and promote their health and to achieve our mission we will evaluate the report and take necessary steps."<BR/><BR/>Interesting word choice: "covenant." While I would not ascribe delusions of godhood to an FDA administrator, "covenant" does imply that the FDA undertakes some responsibilities for the welfare of the people, SO LONG AS the people behave themselves. That part of the meaning, I like: patients cannot simply blame the meds for any and every health consequence.<BR/><BR/>However, another implication of "covenant" is that it's a bilateral commitment, without recourse to outside authority. Sure, if I were an FDA administrator, I'd love to regard myself as the authority of last resort; however, a Senator or two come to mind who have contrary views, quite legitimately.<BR/><BR/>I am, of course, reading volumes into one word in a press release. Yet, I believe this word suggests a couple of themes to watch as this new debate on the future of the FDA plays out.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-1159268604725760522006-09-26T07:03:00.000-04:002006-09-26T07:03:00.000-04:00George,Thanks for the comment. You are right that ...George,<BR/><BR/>Thanks for the comment. You are right that the airline analogy may not be a good one -- it was done a bit tongue-in-cheek. The main idea I think I wanted to get across was that flying is perecieved as a high-risk venture by the public, much like taking drugs should be (but isn't). The data don't support the public's perception in both cases. <BR/><BR/>JohnPharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-1159235865330487102006-09-25T21:57:00.000-04:002006-09-25T21:57:00.000-04:00I agree with you that the 3% is good argument demo...I agree with you that the 3% is good argument demonstrates PhRMA's lack of public relations acumen. I do not think, however, that the airline analogy is a good one. The drug business is more like inventing the plane for the first time every time a new drug is born. At least that's the case with the first of a class drug. The "new and improved" products like atenolol coming after propranolol represent a milder case. You simply improve on something that came before. The key industry argument and the one that the IOM also focused on is that you really can't know the true safety of a drug until a large number of patients have been exposed to it over time. I'm not sure that any technique will be found in the short term that will change this basic truth. So, perhaps the PhRMA should have come up with a better rebuttal. I'm sure that some of the drug firms would have done a better job responding the the report. Since the PhRMA is an association that represents everyone in our industry, perhaps it actually serves no one. At least, not very well.Anonymousnoreply@blogger.com