Comments on: How Safe Is That Drug? Get A Rating! http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/ News, Comment and Conversation Fri, 10 Feb 2012 17:00:49 +0000 http://wordpress.org/?v=2.6.2 By: Lisa Van S http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21165 Lisa Van S Wed, 03 Oct 2007 15:00:59 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21165 Reality, Great response..... Reality,
Great response…..

]]> By: Reality http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21163 Reality Wed, 03 Oct 2007 14:51:52 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21163 "What will happen when pharma is able to go directly to the patient?" +++++++++++++++++++++ Too late. It's called DTC advertising. Not to mention the colossally boneheaded Prozac mailing by Lilly a few years ago (http://query.nytimes.com/gst/fullpage.html?res=9C07E2DE1E31F935A35754C0A9649C8B63). “What will happen when pharma is able to go directly to the patient?”
+++++++++++++++++++++
Too late. It’s called DTC advertising. Not to mention the colossally boneheaded Prozac mailing by Lilly a few years ago (http://query.nytimes.com/gst/fullpage.html?res=9C07E2DE1E31F935A35754C0A9649C8B63).

]]> By: sea http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21158 sea Wed, 03 Oct 2007 14:29:41 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21158 I don't like the data-mining possibilities. Doctors have a hard enough time responding to reps who have their prescribing information - what will happen when pharma is able to go directly to the patient? Are we going to see scenarios where a rep is calling patients and telling them that their product will work better so ask your doctor for a scrip? Another question - if Quintiles has "helped develop or commercialize" the top 30 best-selling drugs (as Paul says), why hasn't "risk... been communicated very well to consumers, or in a timely fashion"? If you help develop and commercialize a drug don't you bear some responsibility for safety? It all sounds fishy to me. I'll do my own research. I don’t like the data-mining possibilities. Doctors have a hard enough time responding to reps who have their prescribing information - what will happen when pharma is able to go directly to the patient? Are we going to see scenarios where a rep is calling patients and telling them that their product will work better so ask your doctor for a scrip?

Another question - if Quintiles has “helped develop or commercialize” the top 30 best-selling drugs (as Paul says), why hasn’t “risk… been communicated very well to consumers, or in a timely fashion”? If you help develop and commercialize a drug don’t you bear some responsibility for safety?

It all sounds fishy to me. I’ll do my own research.

]]> By: Chris http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21154 Chris Wed, 03 Oct 2007 13:39:49 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21154 Paul, as I understand it people registering with iguard have to upload the various drugs they are using so each person's profile is taken into account and the particular combo of drugs they are on is taken into account in their personalized risk factors. And Ed, I think this topic of CROs' impartiality was touched on before. I said then that their business is too large to jeopardise by skewing results. The trials they conduct are subject to the same guidelines, inclusion/exclusion criteria and reporting conventions as any other - academic, industry or whatever. They are expected to (and do) operate under the same ethical guidelines as any other investigator. And I do not work at Quintiles or any other CRO. I just happen to know how it works. Chris Paul, as I understand it people registering with iguard have to upload the various drugs they are using so each person’s profile is taken into account and the particular combo of drugs they are on is taken into account in their personalized risk factors.

And Ed, I think this topic of CROs’ impartiality was touched on before. I said then that their business is too large to jeopardise by skewing results. The trials they conduct are subject to the same guidelines, inclusion/exclusion criteria and reporting conventions as any other - academic, industry or whatever. They are expected to (and do) operate under the same ethical guidelines as any other investigator.

And I do not work at Quintiles or any other CRO. I just happen to know how it works.
Chris

]]> By: Laurie http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21124 Laurie Wed, 03 Oct 2007 01:51:37 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21124 The fact that Iguard is spamming web based message boards, mine included, is a big red flag for me. The fact that Iguard is spamming web based message boards, mine included, is a big red flag for me.

]]> By: Ed Silverman http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21103 Ed Silverman Tue, 02 Oct 2007 20:11:52 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21103 Hi Paul, You asked a good question. And there would be a problem if, for instance, a Quintiles-run trial overlooked some data, or worse. Of course, that would create all sorts of issues before we even think about iGuard. Another question, perhaps, is whether a drug would get a more favorable rating if Quintiles was involved the trials. We don't know, although the company is involved in so many trials that, theoretically, many drug ratings would be open to question. This is all hypothetical. What's interesting is the small number of iGuard's 'clinical review team,' and the large number of drugs. Simply put, a larger team may be desirable. And those undisclosed consulting ties should be disclosed - at the very least. I think the site will be interesting to watch and generate more fodder for comment as it progresses. We'll be watching. Thanks for writing, ed at Pharmalot Hi Paul,

You asked a good question. And there would be a problem if, for instance, a Quintiles-run trial overlooked some data, or worse. Of course, that would create all sorts of issues before we even think about iGuard.

Another question, perhaps, is whether a drug would get a more favorable rating if Quintiles was involved the trials. We don’t know, although the company is involved in so many trials that, theoretically, many drug ratings would be open to question.

This is all hypothetical. What’s interesting is the small number of iGuard’s ‘clinical review team,’ and the large number of drugs. Simply put, a larger team may be desirable. And those undisclosed consulting ties should be disclosed - at the very least.

I think the site will be interesting to watch and generate more fodder for comment as it progresses. We’ll be watching.

Thanks for writing,

ed at Pharmalot

]]> By: Hank http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21100 Hank Tue, 02 Oct 2007 19:41:03 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21100 It's not as immediate in terms of "the latest," but Therapeutics Initiative in BC is another great site to get good, evidence-based analyses. It’s not as immediate in terms of “the latest,” but Therapeutics Initiative in BC is another great site to get good, evidence-based analyses.

]]> By: Reality http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21099 Reality Tue, 02 Oct 2007 19:35:02 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21099 I'm very disappointed in the readership of Pharmalot that it took over 3 hours for someone to point out the relationship of Quintiles to pharmaceutical development, CME, etc. You guys are slipping! ;-) Also, I have to say -- and forgive the superficiality -- but iGuard's leadership team (http://www.iguard.org/help/about/leadership.html) better do something about those photos if they want their site to be taken as a serious source of pharma safety info. The lack of professionalism with their casual couch and vacation photos doesn't exactly instill a lot of confidence. I’m very disappointed in the readership of Pharmalot that it took over 3 hours for someone to point out the relationship of Quintiles to pharmaceutical development, CME, etc. You guys are slipping! ;-)

Also, I have to say — and forgive the superficiality — but iGuard’s leadership team (http://www.iguard.org/help/about/leadership.html) better do something about those photos if they want their site to be taken as a serious source of pharma safety info. The lack of professionalism with their casual couch and vacation photos doesn’t exactly instill a lot of confidence.

]]> By: Paul Joannides http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21093 Paul Joannides Tue, 02 Oct 2007 18:18:42 +0000 http://www.pharmalot.com/2007/10/how-safe-is-that-drug-get-a-rating/#comment-21093 You report that iGuard's biggest backer is Quintiles. On their website, Quintiles says, "Quintiles has helped develop or commercialize all 30 of the world's top 30 best-selling drugs." Forgive me, as I don't know about the safeguards in your industry, but how does this differ from the fox guarding the hen house? Also, it seems like the biggest risk occurs when a patient is taking multiple drugs. For instance, Drug X by itself might not be a problem, but what is the risk if you are taking Drug X, Drug Y and Drug Z? Is this something that iGuard can help patients assess? You report that iGuard’s biggest backer is Quintiles. On their website, Quintiles says, “Quintiles has helped develop or commercialize all 30 of the world’s top 30 best-selling drugs.”

Forgive me, as I don’t know about the safeguards in your industry, but how does this differ from the fox guarding the hen house?

Also, it seems like the biggest risk occurs when a patient is taking multiple drugs. For instance, Drug X by itself might not be a problem, but what is the risk if you are taking Drug X, Drug Y and Drug Z? Is this something that iGuard can help patients assess?

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