Comments on: FDA Issues New Rules For Advisory Committees http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/ News, Comment and Conversation Fri, 10 Feb 2012 22:24:13 +0000 http://wordpress.org/?v=2.6.2 By: Dan http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368927 Dan Fri, 08 Aug 2008 00:41:43 +0000 http://www.pharmalot.com/?p=14958#comment-368927 I beg to differ with Laurie; most of the time the decisions are NOT cut and dried. Interpreting data is NOT black or white. Many factors are involved, and decisions have to be made in the context of the inclusion/exclusion criteria, protocol design, statistical analysis plan, the actual data obtained, the ADRs (and opinions of whether they are related to the drug or to the underlying disease) and many more factors. The FDA asks these Advisory Committee members specific questions for consideration that requires more than just the ability to look at numbers and listen to the public. For that, I'd want the biggest experts in the field, and if some have some COI, than as long as it's disclosed, then the FDA can weigh their input accordingly. To exclude them is to cut off some of the best advise available. Frankly, the public member is a waste of resources; they are there for political purposes...they add next to nothing to the consideration. I beg to differ with Laurie; most of the time the decisions are NOT cut and dried. Interpreting data is NOT black or white. Many factors are involved, and decisions have to be made in the context of the inclusion/exclusion criteria, protocol design, statistical analysis plan, the actual data obtained, the ADRs (and opinions of whether they are related to the drug or to the underlying disease) and many more factors. The FDA asks these Advisory Committee members specific questions for consideration that requires more than just the ability to look at numbers and listen to the public. For that, I’d want the biggest experts in the field, and if some have some COI, than as long as it’s disclosed, then the FDA can weigh their input accordingly. To exclude them is to cut off some of the best advise available. Frankly, the public member is a waste of resources; they are there for political purposes…they add next to nothing to the consideration.

]]> By: Laurie http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368745 Laurie Wed, 06 Aug 2008 00:34:54 +0000 http://www.pharmalot.com/?p=14958#comment-368745 ". Besides, do we really want input from those who have fewer credentials in the field? " Credentials are completely different than those that will gain financially from a drugs approval or who have a bias towards approval. There are plenty of experts who can and would serve on an Advisory Committee. Advisory Committees typically interpret data, that does not require an intimate knowledge of a particular drug. They even have a "public member" with minimal experience.It's about evaluting risk vs benefit, that doesn't require a job/consulting contract with a specific manufacturer. It requires an ability to look at date, listen to public testimony and make a decision based on that. Pretty cut and dried. “. Besides, do we really want input from those who have fewer credentials in the field? ”

Credentials are completely different than those that will gain financially from a drugs approval or who have a bias towards approval. There are plenty of experts who can and would serve on an Advisory Committee. Advisory Committees typically interpret data, that does not require an intimate knowledge of a particular drug. They even have a “public member” with minimal experience.It’s about evaluting risk vs benefit, that doesn’t require a job/consulting contract with a specific manufacturer.
It requires an ability to look at date, listen to public testimony and make a decision based on that. Pretty cut and dried.

]]> By: Adirondack http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368741 Adirondack Wed, 06 Aug 2008 00:22:30 +0000 http://www.pharmalot.com/?p=14958#comment-368741 Listening to and speaking at the advisory committee hearings, I would wager that it is not so much the COI per dollar amount, but the morality and ethics of the members. Evil is not only banal, but often results from brutal insensitivity rather than devilish malice. Surely, there much be another measure in addition to cash on hand to find members who are honest and learned. Listening to and speaking at the advisory committee hearings, I would wager that it is not so much the COI per dollar amount, but the morality and ethics of the members. Evil is not only banal, but often results from brutal insensitivity rather than devilish malice.

Surely, there much be another measure in addition to cash on hand to find members who are honest and learned.

]]> By: Dan http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368697 Dan Tue, 05 Aug 2008 15:31:23 +0000 http://www.pharmalot.com/?p=14958#comment-368697 The true experts will always be sought after by industry as consultants, trial sites, etc. These people are very sensitive to attacks on their credibility, so in my experience, they tend to go out of their way to NOT be biased toward the industry. Besides, do we really want input from those who have fewer credentials in the field? Isn't it just as likely that those with no conflicts (and likely lesser expertise) could misinterpret data to claim something is more safe and effective than it really is? For most of the experts involved, $50,000 is not a lot of money, and unlikely to sway their expert opinion. The true experts will always be sought after by industry as consultants, trial sites, etc. These people are very sensitive to attacks on their credibility, so in my experience, they tend to go out of their way to NOT be biased toward the industry. Besides, do we really want input from those who have fewer credentials in the field? Isn’t it just as likely that those with no conflicts (and likely lesser expertise) could misinterpret data to claim something is more safe and effective than it really is? For most of the experts involved, $50,000 is not a lot of money, and unlikely to sway their expert opinion.

]]> By: Laurie http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368662 Laurie Tue, 05 Aug 2008 02:33:27 +0000 http://www.pharmalot.com/?p=14958#comment-368662 "This policy means that the true experts in the field, i.e. those who do clinical trials, would not be able to give their opinion. So let’s ask the opinion of people who don’t do clinical trials, don;t do publications, don’t do CME." No, lets omit those who do the clinical trial as members of the advisory committee. Those that have a connection with the specific drug are free to testify in a public hearing, but they should NOT be in a decision making position that they will benefit from. Those that do the clinical trials are well represented in the data....we need someone who looks at the drug information without bias. “This policy means that the true experts in the field, i.e. those who do clinical trials, would not be able to give their opinion. So let’s ask the opinion of people who don’t do clinical trials, don;t do publications, don’t do CME.”

No, lets omit those who do the clinical trial as members of the advisory committee. Those that have a connection with the specific drug are free to testify in a public hearing, but they should NOT be in a decision making position that they will benefit from.

Those that do the clinical trials are well represented in the data….we need someone who looks at the drug information without bias.

]]> By: Paul G http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368651 Paul G Tue, 05 Aug 2008 01:05:06 +0000 http://www.pharmalot.com/?p=14958#comment-368651 This policy means that the true experts in the field, i.e. those who do clinical trials, would not be able to give their opinion. So let's ask the opinion of people who don't do clinical trials, don;t do publications, don't do CME. I don't think $50K is too high a threshold. This policy means that the true experts in the field, i.e. those who do clinical trials, would not be able to give their opinion. So let’s ask the opinion of people who don’t do clinical trials, don;t do publications, don’t do CME.

I don’t think $50K is too high a threshold.

]]> By: Deborah B http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368643 Deborah B Mon, 04 Aug 2008 23:37:13 +0000 http://www.pharmalot.com/?p=14958#comment-368643 Thanks Ed, for this fascinating discussion. I want to start a pharma company at some point, and I've always been concerned about this COI problem. The problem of COI gets larger, and thornier, in direct proportion to the size of the market/patient population that the drug addresses. Its ubiquitous in this agency, and as in the example of Dr. Scher above, clearly subject to subjective interpretation. I think the FDA needs to re-write the rules for who serves on these committees AGAIN. (Even given the "new rules" guidance.) Tony F is correct. Even a hint of conflict of interest only serves to intimate that we are all ultimately at some risk when we choose to use an FDA-approved drug. (ie: Was this drug approved because it was the best in treating my particular indication? or was it approved because a majority of committee members, all of whom have relationships with the applicant, said it should be?) Eliminating COI, in all it's varieties, should be a top priority. And yes, I personally feel that $50K is too high a threshold. Thanks Ed, for this fascinating discussion. I want to start a pharma company at some point, and I’ve always been concerned about this COI problem. The problem of COI gets larger, and thornier, in direct proportion to the size of the market/patient population that the drug addresses. Its ubiquitous in this agency, and as in the example of Dr. Scher above, clearly subject to subjective interpretation.

I think the FDA needs to re-write the rules for who serves on these committees AGAIN. (Even given the “new rules” guidance.) Tony F is correct. Even a hint of conflict of interest only serves to intimate that we are all ultimately at some risk when we choose to use an FDA-approved drug. (ie: Was this drug approved because it was the best in treating my particular indication? or was it approved because a majority of committee members, all of whom have relationships with the applicant, said it should be?) Eliminating COI, in all it’s varieties, should be a top priority. And yes, I personally feel that $50K is too high a threshold.

]]> By: M Helm, MD http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368640 M Helm, MD Mon, 04 Aug 2008 22:38:07 +0000 http://www.pharmalot.com/?p=14958#comment-368640 If I were the King, I'd look at this differently. I think I would divided the responsibilities of the FDA into at least three broad categories - Human Health, Human Nutrition, and Animal Health and Nutrition. Then I would consider income and assets differently. First, I'd consider income - anyone who derived more than 2% of their individual or family income from any of the interests regulated in relevant area in any of the past five years would require review for a waiver. Anyone with more than 5% of their income would be ineligible for participation in any decision-making or advisory capacity. I would then look at assets, and make the same sort of determinations. However, I'm not the King, and I didn't think about this more than five minutes. It is obvioulsy difficult to set arbitrary cutoffs. Everyone's perspective on "a lot" is different. If I were the King, I’d look at this differently. I think I would divided the responsibilities of the FDA into at least three broad categories - Human Health, Human Nutrition, and Animal Health and Nutrition. Then I would consider income and assets differently. First, I’d consider income - anyone who derived more than 2% of their individual or family income from any of the interests regulated in relevant area in any of the past five years would require review for a waiver. Anyone with more than 5% of their income would be ineligible for participation in any decision-making or advisory capacity. I would then look at assets, and make the same sort of determinations. However, I’m not the King, and I didn’t think about this more than five minutes.

It is obvioulsy difficult to set arbitrary cutoffs. Everyone’s perspective on “a lot” is different.

]]> By: Ed Silverman http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368634 Ed Silverman Mon, 04 Aug 2008 20:05:40 +0000 http://www.pharmalot.com/?p=14958#comment-368634 Hi Atlex, Unfortunately, I don't have a lot of time today to spend on this right now. But I agree it's all too arbitrary, for me as well. As I indicated earlier, I think, I don't have a good answer as to why any one number should be set. But I continue to believe that $50k is still a lot, which is why zero is a tempting solutuion. Again, this is all imperfect. (To answer your other questions, yes, the health plan example could be considered a conflict and same for the panelist who lost the grant, but that's not a financial holding, is it? So that becomes a slightly separate, if related discussion). When I have more time, I'll stop back later. Cheers ed Hi Atlex,

Unfortunately, I don’t have a lot of time today to spend on this right now. But I agree it’s all too arbitrary, for me as well. As I indicated earlier, I think, I don’t have a good answer as to why any one number should be set. But I continue to believe that $50k is still a lot, which is why zero is a tempting solutuion. Again, this is all imperfect. (To answer your other questions, yes, the health plan example could be considered a conflict and same for the panelist who lost the grant, but that’s not a financial holding, is it? So that becomes a slightly separate, if related discussion). When I have more time, I’ll stop back later.

Cheers
ed

]]> By: atlex http://www.pharmalot.com/2008/08/fda-issues-new-rules-for-advisory-committees/#comment-368632 atlex Mon, 04 Aug 2008 19:45:52 +0000 http://www.pharmalot.com/?p=14958#comment-368632 Ed, Why $10K? To some people that's a lot of money. To others, it's not. So why pick that number? I've yet to hear a compelling argument for any specific number. While I vehemently disagree with those who want to eliminate all panelists with even a hint of conflict, at least they have a cogent argument for their non-arbitrary number (ie, $0). Your focus on what the "average person" thinks doesn't work for in my mind for a couple of reasons. First, I don't know of any data to support what the "average person" believes is enough to be considered a conflict. Second, even if there was data, relying on the "average person", while wonderfully democratic, its not necessarily a good way to set public policy. The "average person" may not have a frame of reference for making his or her determination. My concern is not being able to access the world's most knowledgeable experts on a disease because they may have a couple of hundred shares of stock in their kid's 529 account and receive $2500 a piece for 2 speaking engagements. At least the The $50K limit before an outright ban kicks in, gives the FDA some flexibility. By the way, I don't think the policy deals with other types of financial interests that can be conflicts? Suppose a panelist has no pharma holdings that are in conflict, but does receive consulting fees or has stock in health plans. Certainly, the approval of a new high cost drug could hurt profits at the health plan. Is that a conflict we should be concerned with? Supposed a panelist just lost out on a grant from the drug company involved in the review? Should that be noted at a COI or bias? Atlex Ed,

Why $10K? To some people that’s a lot of money. To others, it’s not. So why pick that number? I’ve yet to hear a compelling argument for any specific number. While I vehemently disagree with those who want to eliminate all panelists with even a hint of conflict, at least they have a cogent argument for their non-arbitrary number (ie, $0).

Your focus on what the “average person” thinks doesn’t work for in my mind for a couple of reasons. First, I don’t know of any data to support what the “average person” believes is enough to be considered a conflict. Second, even if there was data, relying on the “average person”, while wonderfully democratic, its not necessarily a good way to set public policy. The “average person” may not have a frame of reference for making his or her determination.

My concern is not being able to access the world’s most knowledgeable experts on a disease because they may have a couple of hundred shares of stock in their kid’s 529 account and receive $2500 a piece for 2 speaking engagements. At least the The $50K limit before an outright ban kicks in, gives the FDA some flexibility.

By the way, I don’t think the policy deals with other types of financial interests that can be conflicts? Suppose a panelist has no pharma holdings that are in conflict, but does receive consulting fees or has stock in health plans. Certainly, the approval of a new high cost drug could hurt profits at the health plan. Is that a conflict we should be concerned with? Supposed a panelist just lost out on a grant from the drug company involved in the review? Should that be noted at a COI or bias?

Atlex

]]>