Day 2 of the FDA Avandia Panel: Live Blogging the End

Meeting Adjourned.

4:33: Konstam: I don’t get him. He’s defended rosi for 2 days and then votes E. Now he votes against TIDE but says it should be cont’d.

4:29: Would love feedback from readers about this live-blogging experiment. This is my first time doing it. Fun but exhausting. Did you find it useful? Any suggestions?

4:27: Should TIDE continue:  yes: 20, no: 10, abstain 2

4:24 Now starting discussion about TIDE. Should it be allowed to continue? (I think given the previous vote they will have to allow TIDE to continue.)

4:21: Konstam says FDA is not broken, doesn’t need to be reorganized, and congratulates Woodcock. I’d like to hear Nissen’s response…

4:01: CardiologyToday’s tweet: “FDA advisory panel voted 20-12 to keep #Avandia on the market.” I hadn’t thought about it in that way exactly. Will this be the headline tomorrow? On the other hand, Matt Herper wrote: “29 voted to strengthen label. It sounds like the mother of all REMS.”

3:55: Vote very hard to interpret. I’m guessing the real winner is D, so that the drug will be allowed to stay on the market but with additional restrictions. This won’t make anyone happy, and there will probably have to be another panel to decide the new restrictions. Does the FDA have a frequent flyer program for drugs?

3:40: RitaRubin:  “so a plurality for withdrawal, but a majority for being on the market???” So this means the Avandia controversy may only be starting! (Why didn’t anyone do the math beforehand?)

3:35: Vote: Withdrawal gets plurality. But note that more total votes to keep it on market. How to interpret?

• A 0
• B 3
• C 7
• D 10
• E 12

1 abstention

3:32: According to the FDA’s Jenkins: Previous withdrawals for CV concerns: Vioxx and Zelnorm

3:25: Now talking about all the reasons and precedents for withdrawing a drug. Jeez, if they haven’t thought about this before this point…

3:05: Konstam: the evidence for harm does not reach a very high standard. Furberg: when rosi was approved the benefit outweighed the harm. Today the risk clearly outweighs the benefit.

3:03: Vote scheduled for 3:10

2:45: Now discussing rosi risk-to-benefit compared to other nonTZDs. This discussion is leading to the BIG question:

Based on the available data, which of the following regulatory actions do you recommend FDA pursue regarding rosiglitazone? Please select only one option or if you wish to abstain, do not vote. (These options are listed from most favorable to rosiglitazone to least favorable to rosiglitazone and do not reflect any prejudgment on the part of FDA.)

A. Allow continued marketing and revise the current label to remove the boxed warning and other warnings regarding an increased risk of ischemic CV events, or

B. Allow continued marketing and make no changes to the current label, or

C. Allow continued marketing and revise the current label to add additional warnings (e.g.,contraindications for certain patient populations, recommendation for second-line use in patients intolerant of or uncontrolled on other anti-diabetic agents); or

D. Allow continued marketing, revise the current label to add additional warnings, and add additional restrictions on use (such as restricting prescribing to certain physicians or requiring special physician and patient education)

E. Withdrawal from the U.S. market

2:43: Hammerschmidt voted C on “datapenia” (I think that’s what he said)

2:38: Live coverage on CNN.com– better picture and video than FDAlive, and MUCH MUCH cheaper

2:28: Question #6 for morality concern for Rosi relative to Pio:

yes 7, no 12, maybe 14

2:25: [corrected count] Vote: Do you have significant concerns about mortality?

A yes 1, B no 20, C not sure 12

2:07: Mortality discussion gets underway. Nice geeky cardiology perspective from Moss, who performs trials on SCD: “I have trouble accepting sudden cardiac death even in a trial that’s looking at sudden cardiac death.”

2:00: Kaul and Kostam resisting efforts to cut off discussion. Good point made by TheHeart.Org: “Comments are all over the map, but in 2007, most agreed that risk existed, then most said the drug should stay available.”

1:58: Discussion over questions 2 & 3 nearly over. Now move on to discussion and question about mortality.

1:51: With solid majority finding harm for rosi in both questions 2 & 3, does this mean it’s already over? But Henderson who voted A still wants to see long term data– is she supporting TIDE?

1:38: Now question 3, same question, but comparing rosi to pio. Vote is 21,4,8. Teerlink voted for B instead of C, as he intended, so the vote is now 21 vs 3 vs 9.

1:36: Voting A= rosi increases risk, B = does not increase risk, C = can’t decide. A= 18, B=6,  C=9

1:30: Now comes voting on questions 2 and 3. They are using electronic voting systems.

1:25: Sanjay Kaul: The key question is quantity and quality of the data. The problem is that the data is really weak.

1:18: Konstam basically agrees with Marciniak that RECORD is hopelessly biased but Teerlink finds only minor problems with the trial.

1:14: Various members now saying they are not concerned by all the issues raised over RECORD.

1:09: Good question to FDA: are we (the panel) setting a precedent by comparing 1 drug to another. Woodcock says yes, I think. But not asking whether you think one drug is superior to another. Temple says this is not an entirely novel issue. (Alicia Ault tweeted: “FDA guru Bob Temple suggests that it’s not unheard of to pull one drug when there are relatively safer alterns in a class.”)

1:05: Panel voting to revise the wording of question #2, as per discussion this morning. Panel votes 16-8 to change the question. Now 25 minutes of questions.

1:00: And we’re off! Chair: not enough time and some will be cut off.

Get ready for the fireworks.