Comments on: Steve Nissen Gives The FDA Some Advice http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/ News, Comment and Conversation Fri, 19 Mar 2010 06:40:15 +0000 http://wordpress.org/?v=2.6.2 By: Vince http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365348 Vince Thu, 03 Jul 2008 12:11:19 +0000 http://www.pharmalot.com/?p=14441#comment-365348 The repeated statement here that Nissen has a lot to gain simply does not hold water. Drug companies are not going to reward a researcher who does not know how to provide the right answer. Read the history of the studies used to get Ketek approved or the NEJM editorial related to Vioxx. With the new trend toward preemption ;how long would dangerous and sometimes lethal drugs unfettered by lawsuits; remain on the market. Nissen is actually stating the old principle "First do no harm" The repeated statement here that Nissen has a lot to gain simply does not hold water. Drug companies are not going to reward a researcher who does not know how to provide the right answer. Read the history of the studies used to get Ketek approved or the NEJM editorial related to Vioxx. With the new trend toward preemption ;how long would dangerous and sometimes lethal drugs unfettered by lawsuits; remain on the market. Nissen is actually stating the old principle “First do no harm”

]]> By: Justice in MI http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365332 Justice in MI Thu, 03 Jul 2008 03:19:06 +0000 http://www.pharmalot.com/?p=14441#comment-365332 As we now know from the thread above, the advisory committee, mostly endocs, voted 14-2 endorsing essentially what Nissen recommended. As we now know from the thread above, the advisory committee, mostly endocs, voted 14-2 endorsing essentially what Nissen recommended.

]]> By: Doc http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365314 Doc Thu, 03 Jul 2008 00:38:45 +0000 http://www.pharmalot.com/?p=14441#comment-365314 Pharma hates Nissan, but it takes someone in his position to get real attention to the issues pharma wants to brush under the carpet. There are a number of agents that work quite well in diabetics, metformin being the major agent with proven CV benefit. Making new agents prove their benefits and/or risks ultimately helps patients. Go Stevie!! Pharma hates Nissan, but it takes someone in his position to get real attention to the issues pharma wants to brush under the carpet.

There are a number of agents that work quite well in diabetics, metformin being the major agent with proven CV benefit. Making new agents prove their benefits and/or risks ultimately helps patients.

Go Stevie!!

]]> By: Meg http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365311 Meg Wed, 02 Jul 2008 22:43:27 +0000 http://www.pharmalot.com/?p=14441#comment-365311 I will never forget the FDA's ADHD hearing when Steve Nissan boldly called for a vote for black box warnings for this array of dangerous drugs for children. The FDA was shocked. SHOCKED! His committee was not supposed to do that but the vote passed 8-7. What a hero (to me). Unfortunately, it was business as usual when the Pediatrics Committee reversed this vote when they met later. Not too many heroes on the FDA Advisory Committees. As I recall, Dr. Kurt Fuhrberg also spoke out in favor of the warning. I will never forget the FDA’s ADHD hearing when Steve Nissan boldly called for a vote for black box warnings for this array of dangerous drugs for children. The FDA was shocked. SHOCKED! His committee was not supposed to do that but the vote passed 8-7. What a hero (to me). Unfortunately, it was business as usual when the Pediatrics Committee reversed this vote when they met later.

Not too many heroes on the FDA Advisory Committees. As I recall, Dr. Kurt Fuhrberg also spoke out in favor of the warning.

]]> By: Justice in MI http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365308 Justice in MI Wed, 02 Jul 2008 22:00:45 +0000 http://www.pharmalot.com/?p=14441#comment-365308 From the bits and pieces that have come out, it appears that some very senior science people in Merck wanted to do precisely this even before Vioxx was approved, and certainly afterward. They were overridden for a variety of reasons, although - yes VIGOR, et. al., did go forward, as well as AdVANTAGE. While not done to assess CV events, they were certainly being monitored. Wider point being - as above, this may or may not cause signficiant delay. And it may or may not be something that some comapanies would do anyway. From the bits and pieces that have come out, it appears that some very senior science people in Merck wanted to do precisely this even before Vioxx was approved, and certainly afterward. They were overridden for a variety of reasons, although - yes VIGOR, et. al., did go forward, as well as AdVANTAGE. While not done to assess CV events, they were certainly being monitored.

Wider point being - as above, this may or may not cause signficiant delay. And it may or may not be something that some comapanies would do anyway.

]]> By: Marilyn Mann http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365304 Marilyn Mann Wed, 02 Jul 2008 20:23:47 +0000 http://www.pharmalot.com/?p=14441#comment-365304 There are sometimes earlier approvals for orphan diseases. I don't know offhand how long these preapproval trials would take. If I find out anything I'll let you know. There are sometimes earlier approvals for orphan diseases.

I don’t know offhand how long these preapproval trials would take. If I find out anything I’ll let you know.

]]> By: Nathan http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365299 Nathan Wed, 02 Jul 2008 19:56:42 +0000 http://www.pharmalot.com/?p=14441#comment-365299 That's a good point Marilyn -- maybe my 3-6 year estimate was off. How long would a CV harm test take? 1-2 years? It seems that a pretty large patient population would have to be used. That would be fine for a major therapeutic area (diabetes) but would devastate research in orphan metabolic diseases. Hopefully an exemption would be made based on therapeutic market size. That’s a good point Marilyn — maybe my 3-6 year estimate was off. How long would a CV harm test take? 1-2 years? It seems that a pretty large patient population would have to be used. That would be fine for a major therapeutic area (diabetes) but would devastate research in orphan metabolic diseases. Hopefully an exemption would be made based on therapeutic market size.

]]> By: Marilyn Mann http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365290 Marilyn Mann Wed, 02 Jul 2008 18:30:56 +0000 http://www.pharmalot.com/?p=14441#comment-365290 OK, my information is that he recommended that the preapproval trials be required to show no cardiovascular harm. He also recommended that the companies be required to conduct large post-approval trials with cardiovascular endpoints very soon after approval. OK, my information is that he recommended that the preapproval trials be required to show no cardiovascular harm. He also recommended that the companies be required to conduct large post-approval trials with cardiovascular endpoints very soon after approval.

]]> By: truthman30 http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365289 truthman30 Wed, 02 Jul 2008 18:25:09 +0000 http://www.pharmalot.com/?p=14441#comment-365289 hahaha... Nathan and Atlex.... You have to be joking right? Dr Nissen has saved many lives with his Avandia warning, he is totally on the side of the consumer, and you guys try to discredit him.. Give credit where credit is due guys... hahaha…

Nathan and Atlex….

You have to be joking right?

Dr Nissen has saved many lives with his Avandia warning, he is totally on the side of the consumer, and you guys try to discredit him..

Give credit where credit is due guys…

]]> By: James http://www.pharmalot.com/2008/07/steve-nissen-gives-the-fda-some-advice/#comment-365287 James Wed, 02 Jul 2008 18:13:08 +0000 http://www.pharmalot.com/?p=14441#comment-365287 Nathan, surely you wouldn't impugn the credibility and unbiased viewpoint of Dr. Nissen, would you? The same man who touted a meta-study to prove a drug was dangerous, even though he had previously discounted the validity of meta-studies as a whole? The same man who so strongly criticizes industry, yet refuses almost all invitations to speak at and defend his view at industry conferences? How dare you? ;) Nathan, surely you wouldn’t impugn the credibility and unbiased viewpoint of Dr. Nissen, would you?

The same man who touted a meta-study to prove a drug was dangerous, even though he had previously discounted the validity of meta-studies as a whole?

The same man who so strongly criticizes industry, yet refuses almost all invitations to speak at and defend his view at industry conferences?

How dare you? ;)

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