Did we not know all this process already? I am so UPSET with the way our TAX dollars are spent. I still feel that you need to read this and come to your own conclusions so putting it up on my BLOG
---------------------------------------------------------------------------------------------
Dear Verso,
Thank you for communicating your concerns to the U.S. Food and Drug Administration (FDA or the Agency) about the lorcaserin advisory committee meeting. As you know, on September 16, 2010, FDA held a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Advisory Committee) to discuss the safety and efficacy of lorcaserin, a drug developed by Arena Pharmaceuticals, Inc. (Arena) to treat obesity. The Advisory Committee—made up of physicians, scientists, statisticians, and patient and consumer representatives— reviewed extensive background information prior to the meeting. The sponsor, FDA staff, and members of the public gave presentations during the Advisory Committee meeting. After thoroughly considering all the available information, the Advisory Committee voted 9-5 to recommend that FDA not approve lorcaserin for marketing.
After the Advisory Committee meeting, FDA began receiving correspondence from numerous parties questioning the views of FDA staff and comments made by FDA staff during the meeting, as well as accusations that scientists with appropriate expertise had not evaluated lorcaserin’s safety and efficacy data. FDA takes all comments and concerns about advisory committee proceedings seriously and wants to take this opportunity to address some of the concerns about our policies and procedures.
FDA achieves its mission to protect and promote the public health through rigorous evaluation of all data submitted in support of a new drug application (NDA). Often, the data submitted raise challenging or novel scientific issues relating to the drug’s safety and/or efficacy. FDA advisory committees serve an important function by providing the Agency with an independent, expert evaluation of the data during the drug review process. FDA ensures that during the meeting, the full spectrum of views of the data are presented to the committee and that all committee members have the opportunity to ask questions and present their own views on the data. FDA staff also routinely present their own reviews, conclusions, and individual perspectives of the data. This practice ensures that differing opinions are transparently presented and debated and allows the committee to make recommendations after taking into account all perspectives. This public process helps FDA obtain expert advice during the review process and increases the transparency to those with an interest in a particular matter. Although FDA highly values the opinions of the independent experts on the committee and often incorporates those opinions into its decision-making process, FDA makes the final decision about whether a drug should be approved. Advisory committee votes and recommendations are not binding on the Agency.
FDA has strict rules governing conflicts of interest for both employees and advisory committee members. With certain limited exceptions, FDA employees and their families cannot hold a financial interest in any company that is significantly regulated by FDA. FDA employees must report their financial interests on a yearly basis and their reports are reviewed by Agency ethics staff. FDA has not been made aware of any evidence to suggest that these rules were not followed by the FDA staff at the lorcaserin Advisory Committee meeting.
Similarly, advisory committee members must report to FDA any financial interests they hold related to the subject matter of the advisory committee meeting. FDA screens advisory committee members broadly for financial or other relationships that could present even the appearance that they have conflicts of interest that could affect their impartiality. For the lorcaserin meeting, as with all advisory committee meetings, all Advisory Committee members were appropriately screened for conflicts of interest.
Although FDA strives to have broad representation of appropriate medical and scientific specialties on its advisory committees, optimal representation is often difficult to achieve given the strict conflict-of-interest regulations that apply, as well as calendar conflicts, which may limit the availability of experts for the selected meeting dates. The lorcaserin Advisory Committee included representation from the fields of Endocrinology, Cardiology, Pharmacology, Health Policy, Epidemiology, Biostatistics, Internal Medicine, and Clinical Research. In hindsight, FDA regrets that no toxicologist participated in the meeting. However, a team of FDA toxicology experts reviewed the lorcaserin NDA and interpreted the data related to the lorcaserin carcinogenicity studies. Moreover, the lorcaserin carcinogenicity studies were also thoroughly reviewed and discussed by the Center for Drug Evaluation and Research (CDER) Executive Carcinogenicity Assessment Committee, and the results of this scientific assessment were included in the background documents provided to the committee and discussed in Agency presentations at the Advisory Committee meeting.
Consistent with the FDA’s policy on transparency, FDA announces the dates for advisory committee meetings in advance through publication of a notice in the Federal Register, and the Agency posts all advisory committee briefing materials on its public website 48 hours prior to the meeting. Prior to the public posting of the documents, they are kept in strict confidentiality with only the advisory committee members and the sponsor having the opportunity to review them. As soon as possible after an advisory committee meeting has concluded, a transcript of the meeting is made available on FDA’s public website. In this way, the diverse views of all participants, both FDA employees and advisory committee members, are made available to the public.
After obtaining advisory committee input on an NDA, FDA completes its review of the application and communicates its findings to the sponsor. FDA considers all of the data contained in the application and conducts its own independent analysis of the data before making a decision as to whether the benefits of the drug outweigh its risks for the proposed use. FDA believes that this rigorous review process leads to the most appropriate decisions about the safety and efficacy of proposed new drugs.
FDA remains committed to ensuring that its advisory committee process is conducted according to applicable statutes and regulations and will continue to make these proceedings transparent to the American public. With regard to the specific allegations made against FDA staff, FDA will continue to review these allegations and if misconduct is identified, will take appropriate action.
Again, we appreciate you taking the time to express your concerns.
Sincerely,
Division of Drug Information BLS
Center for Drug Evaluation and Research
Food and Drug Administration
Sept 20, 2010
Margaret Hamburg, M.D.
Commissioner, Food and Drug Administration
10903 New Hampshire Ave
Silver Spring , MD 20993
Commissioner, Food and Drug Administration
10903 New Hampshire Ave
Silver Spring , MD 20993
Dear Dr. Hamburg ,
I write this e-mail to you in hope that FDA will do the right thing in case of Lorqess a novel compound developed by Arena Pharmaceuticals for treating obese patients.
From FDAs own guidance on carcenogenicity studies
"It has been agreed that if a drug is only positive in rodents at doses above those producing a 25 fold exposure over exposure in humans, such a finding would not be considered likely to reflect a relevant risk to humans. I would like you to note that Rodents were dosed 84 fold, hence by FDA' own guidelines Rat Tumor issue should never have been the focal point of discussion. It is a non issue which was highlighted to panelists who were not carcenogenic experts.
Excerpt from FDA guidelines
Link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074919.pdf
"Note 11
It has been agreed that if a drug is only positive in rodents at doses above those producing a 25 fold exposure over exposure in humans, such a finding would not be considered likely to reflect a relevant risk to humans.
It has been shown that systemic exposure comparisons between rodents and humans are better estimated by a dose using mg/m2 than using mg/kg (see Note 3 above). Therefore, the human dose should be at least 25-fold lower on a mg/m2 basis than the high dose in the carcinogenicity study. The factor 6-7 (6.5) is used to convert rat doses from mg/kg to mg/m2 and the factor 40 is used to convert human doses from mg/kg to mg/m2. Thus, the estimated systemic exposure ratio of 25-fold rodent/human is equal to about a 25-fold mg/m2 ratio or a 150-fold mg/kg ratio (150 ≈ 25 x 40/6.5). Therefore a human dose below 10 mg/kg/day (about 500 mg/day or less) could be tested in rats at 1500 mg/kg as the high dose."
I disagree with the advisory committee vote on 9-16-2010 which was 9 to 5 against Lorcaserin(Lorqess). Lorcaserin clearly met one of two of the pre-established 2007 criteria for efficacy on obesity drugs. I would love to see obese patients have the option to take Lorcaserin and lose an average of 17 pounds in a year, to have 2/3 of obese patients on Lorcaserin lose 26 pounds in a year, and to have 1/4 of obese patients lose 35 pounds in a year.
Regarding the rat studies, cancer expert Gary Williams from new york said that the cancers seen in one species of rat did not apply to humans, that excess cancer was not seen in mice, and that excess cancer was not seen in the human studies. A clear distinction must be made between Fibroadenomas (benign) and Adenocarcinomas, (malignant) in the breast. As I understand it, the dose of Lorcaserin in the rats had to be 82 times that of the human dose to cause the Adenocarcinomas. The right thing for the FDA to do is to review all rat data in detail and if that is not applicable to humans then Approve Lorqess and let physicians and patients have an additional option to choose from.
My concerns and questions about how FDA handled the Lorqess drug review meeting
1. Can FDA change guidelines after approving clinical trails, if yes then would that apply to clinical trails that commenced prior to the date of new guideline issuance?
2. If FDA was concerned about rat tumors then why did they even allow Arena to start clinical trials (Phase I, II, and III) and try it on 8000+ humans? When Arena discussed the data with FDA; why did FDA not stop the clinical trials?
3. Why did FDA not have a Carcinogenic expert and Oncologist on the panel if the focal point of the meeting would be Rat Tumors? Thus drug did not cause tumors in Monkey's or Mice, why was that not discussed at all?
4. Why did Eric Colman make public statements after Vivus' Qnexa review like
"When you listen to even the 'no' voters, you got the sense a lot of people had a little bit of hesitancy," FDA Deputy Director for Endocrine Products Eric C. Colman, MD, said in a news conference. "They were not strongly against the drug but had lingering concerns that made them vote 'no.'"
“I was a little surprised that the vote went as it did,” said Eric Colman, the deputy director of the FDA Division of Metabolism and Endocrinology Products, in a press briefing after the meeting. He declined to elaborate.
Is this legal or is it violation of code of conduct?
5. Can FDA personnel play scare tactics by making intimidating statements like
"your name would be forever attached to a drug that you helped approve and then recalled"
So does this mean Eric Colman thought this drug would be recalled if approved? On what basis? scientific or non-scientific?
6. When FDA is the final authority to approve or deny why would panelists names be of such an importance?
7. Last but not the least, how is it that one nanosecond after FDA briefing docs are made public the analysts and MSM have articles up on line and ready to go? Did they take a speed reading class? And, more to the point: why did they have short positions as of about a month ago, before there was any real news to trade on?
Were the documents leaked ahead of time?
Meridia; a drug that is much less efficacious and actually doesn't even meet FDA' 2007 guidelines and has lot more side effects was reviewed by pretty much the same panel and surprisingly tumors were not the topic of discussion. Meridia is pulled out of Europe for its safety concerns, why is it still available in the US market? It is my understanding that any drug can be dangerous at a toxic dose so not sure why that is an issue with Lorqess. Denying a novel compound which improved life style,controlled sugar levels, controlled LDL and met FDA efficacy and safety guidelines is a mistake that should be avoided, I plead you and FDA to review this matter as it deserves utmost attention.
Note: Lorqess met both efficacy and safety benchmarks, Valvular issues were ruled out in human trails.
I'd also like you to investigate the events and I hope you take necessary action to prevent any unprofessional conduct of any FDA employee.
Full disclosure: I have a small LONG position in ARNA but that doesn't make this letter invalid by any means.
Sincerely,
Raghu
----------------------------------------------------- ------------------------------------------------------- --------
P.S. The excerpts for your reference:
#1
Source: http://neurologicalcorrelates.com/wordpress/2010/09/15/lorcaserin-fraud-and-market-manipulation-nah-clairvoyance-and-speed-reading/#comments
We wonder if a secret FDA document with material, market moving information was selectively released only to large financial people.
How is it that one nanosecond after FDA briefing docs are made public the analysts and msm have articles up on line and ready to go?
Did they take a speed reading class? And, more to the point: why did they have short positions as of about a month ago, before there was any real news to trade on?
----------------------------------------------------- ------------------------------------------------------- --------
#2
Source: http://klljinvestments.blogspot.com/2010/09/arena-panel-set-up-for-failure.html
The panel itself was a complete disappointment and it is sad to see a group such as this one, decide the fate of a drug that by all accounts had very safe results and approvable, clinically significant weight loss. Deputy Director Colman should receive much of the blame. He pre-disposed the panel on how to vote. Colman stressed how it ‘barely met guidelines’ in his briefing document and in the panel discussion. The FDA focused only on the placebo adjusted weight loss and not ever discussing the impressive subgroup that lost at least 10% (I also am disappointed ARNA didn’t spend more time focusing on this.) I think it was Felner maybe who finally called Colman out on it wanting to know if it met efficacy guidelines or not. If categorical weight loss wasn’t enough then why are they even having the meeting? When another panel member asked if it is sometimes better to pass a drug and get more data then recall it later in certain circumstances. Colman’s response was a smug one stating that your name would be forever attached to a drug that you helped approve and then recalled. That makes anyone on the fence, and most of them were, vote no.
----------------------------------------------------- ------------------------------------------------------- --------
DATE:
19 August 2010
FROM:
Eric Colman, MD
Deputy Director
Division of Metabolism and Endocrinology Products (DMEP) Office of Drug Evaluation II Center for Drug Evaluation & Research
U.S. Food & Drug Administration
When gauged by the standards of the Division’s 2007 draft guidance for Developing Products for Weight Management, the mean weight loss associated with the lorcaserin 10 mg QD and BID dose was about 3% greater than the mean weight loss with placebo. Therefore Lorcaserin did not satisfy the guidance’s mean efficacy criterion. However, the lorcaserin 10 mg BID dose did, by a slim margin, satisfy the categorical efficacy criterion.
----------------------------------------------------- ------------------------------------------------------- --------
July 15, 2010
FDA Panel Says 'No' to Weight Loss Drug Qnexa
"When you listen to even the 'no' voters, you got the sense a lot of people had a little bit of hesitancy," FDA Deputy Director for Endocrine Products Eric C. Colman, MD, said in a news conference. "They were not strongly against the drug but had lingering concerns that made them vote 'no.'"
----------------------------------------------------- ------------------------------------------------------- --------
Vivus Plunges Most Ever After U.S. Review of Qnexa
July 16, 2010,
“I was a little surprised that the vote went as it did,” said Eric Colman, the deputy director of the FDA’s Division of Metabolism and Endocrinology Products, in a press briefing after the meeting. He declined to elaborate.
----------------------------------------------------- ------------------------------------------------------- --------
“Lorcaserin did not satisfy the guidance’s mean efficacy criterion,” said Eric Colman,
Lorcaserin only barely satisfied the first criteria, and didn’t meet the second, the agency said.
----------------------------------------------------- ------------------------------------------------------- --------
2010-07-15
VIVUS Confident Though FDA Panel Rejects Qnexa
The FDA is expected to make a final ruling on Qnexa on October 28, 2010. The agency usually follows its panel recommendations but isn't required to. However, they often considers close votes a split decision. Eric Colman, FDA’s deputy director of its metabolic and endocrinology products division said, “"They weren't strongly against the drug but had lingering concerns.”
----------------------------------------------------------------------------------------------------------------------
Arena Pharmaceuticals conference call
May 7th, 2010
Question from Jason Zhang -- BMO Capital Markets
"another question is, umm, you know a couple days ago I went to a your competitors lunch and they were suggesting that the FDA's approval, umm, I guess, hurdle is a working in progress and..you know, the old five percent weight loss as the benchmark, could change
ahhh you know I don't have anything specific because mentioning that I wonder during your dialogue with the FDA is that something you heard could the FDA be using a new benchmark, other than the five percent average weight loss?"
----------------------------------------------------------------------------------------------------------------------
July 16, 2010
FDA Panel Rejects Vivus Obesity Pill Qnexa
Eric Colman, deputy director of the FDA's Division of Metabolism and Endocrinology Products, noted that the agency's current draft guidelines only call for one year of safety data.
He told reporters after the meeting that based on the outcome of Thursday's committee and the upcoming panels for lorcaserin and Contrave, the FDA likely will update that guidance before releasing a final version of the document.
----------------------------------------------------------------------------------------------------------------------
Dr. Jessica Henderson
After Meridia Panel:
"I think that just because we didn't measure the benefits scientifically doesn't mean they don't exist," said Dr. Jessica Henderson of Western Oregon University . "I don't think a consumer's right to have that treatment should be taken away just because the scientists didn't do their job."
http://www.wtop.com/?nid=106&sid=2053842
After Lorcaserin Panel:
"I voted no because there is too much uncertainty about brain and breast tumor development and too much uncertainty about the actual population this drug would be used in," said Dr. Jessica Henderson, of Western Oregon University .
http://www.wtop.com/?nid=106&sid=2052408
---------------------------------------------------------------------------------------------------------------------
From FDAs own guidance on carcenogenicity studies
"It has been agreed that if a drug is only positive in rodents at doses above those producing a 25 fold exposure over exposure in humans, such a finding would not be considered likely to reflect a relevant risk to humans. I would like you to note that Rodents were dosed 84 fold, hence by FDA' own guidelines Rat Tumor issue should never have been the focal point of discussion. It is a non issue which was highlighted to panelists who were not carcenogenic experts.
Excerpt from FDA guidelines
Link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074919.pdf
"Note 11
It has been agreed that if a drug is only positive in rodents at doses above those producing a 25 fold exposure over exposure in humans, such a finding would not be considered likely to reflect a relevant risk to humans.
It has been shown that systemic exposure comparisons between rodents and humans are better estimated by a dose using mg/m2 than using mg/kg (see Note 3 above). Therefore, the human dose should be at least 25-fold lower on a mg/m2 basis than the high dose in the carcinogenicity study. The factor 6-7 (6.5) is used to convert rat doses from mg/kg to mg/m2 and the factor 40 is used to convert human doses from mg/kg to mg/m2. Thus, the estimated systemic exposure ratio of 25-fold rodent/human is equal to about a 25-fold mg/m2 ratio or a 150-fold mg/kg ratio (150 ≈ 25 x 40/6.5). Therefore a human dose below 10 mg/kg/day (about 500 mg/day or less) could be tested in rats at 1500 mg/kg as the high dose."
I disagree with the advisory committee vote on 9-16-2010 which was 9 to 5 against Lorcaserin(Lorqess). Lorcaserin clearly met one of two of the pre-established 2007 criteria for efficacy on obesity drugs. I would love to see obese patients have the option to take Lorcaserin and lose an average of 17 pounds in a year, to have 2/3 of obese patients on Lorcaserin lose 26 pounds in a year, and to have 1/4 of obese patients lose 35 pounds in a year.
Regarding the rat studies, cancer expert Gary Williams from new york said that the cancers seen in one species of rat did not apply to humans, that excess cancer was not seen in mice, and that excess cancer was not seen in the human studies. A clear distinction must be made between Fibroadenomas (benign) and Adenocarcinomas, (malignant) in the breast. As I understand it, the dose of Lorcaserin in the rats had to be 82 times that of the human dose to cause the Adenocarcinomas. The right thing for the FDA to do is to review all rat data in detail and if that is not applicable to humans then Approve Lorqess and let physicians and patients have an additional option to choose from.
My concerns and questions about how FDA handled the Lorqess drug review meeting
1. Can FDA change guidelines after approving clinical trails, if yes then would that apply to clinical trails that commenced prior to the date of new guideline issuance?
2. If FDA was concerned about rat tumors then why did they even allow Arena to start clinical trials (Phase I, II, and III) and try it on 8000+ humans? When Arena discussed the data with FDA; why did FDA not stop the clinical trials?
3. Why did FDA not have a Carcinogenic expert and Oncologist on the panel if the focal point of the meeting would be Rat Tumors? Thus drug did not cause tumors in Monkey's or Mice, why was that not discussed at all?
4. Why did Eric Colman make public statements after Vivus' Qnexa review like
"When you listen to even the 'no' voters, you got the sense a lot of people had a little bit of hesitancy," FDA Deputy Director for Endocrine Products Eric C. Colman, MD, said in a news conference. "They were not strongly against the drug but had lingering concerns that made them vote 'no.'"
“I was a little surprised that the vote went as it did,” said Eric Colman, the deputy director of the FDA Division of Metabolism and Endocrinology Products, in a press briefing after the meeting. He declined to elaborate.
Is this legal or is it violation of code of conduct?
5. Can FDA personnel play scare tactics by making intimidating statements like
"your name would be forever attached to a drug that you helped approve and then recalled"
So does this mean Eric Colman thought this drug would be recalled if approved? On what basis? scientific or non-scientific?
6. When FDA is the final authority to approve or deny why would panelists names be of such an importance?
7. Last but not the least, how is it that one nanosecond after FDA briefing docs are made public the analysts and MSM have articles up on line and ready to go? Did they take a speed reading class? And, more to the point: why did they have short positions as of about a month ago, before there was any real news to trade on?
Were the documents leaked ahead of time?
Meridia; a drug that is much less efficacious and actually doesn't even meet FDA' 2007 guidelines and has lot more side effects was reviewed by pretty much the same panel and surprisingly tumors were not the topic of discussion. Meridia is pulled out of Europe for its safety concerns, why is it still available in the US market? It is my understanding that any drug can be dangerous at a toxic dose so not sure why that is an issue with Lorqess. Denying a novel compound which improved life style,controlled sugar levels, controlled LDL and met FDA efficacy and safety guidelines is a mistake that should be avoided, I plead you and FDA to review this matter as it deserves utmost attention.
Note: Lorqess met both efficacy and safety benchmarks, Valvular issues were ruled out in human trails.
I'd also like you to investigate the events and I hope you take necessary action to prevent any unprofessional conduct of any FDA employee.
Full disclosure: I have a small LONG position in ARNA but that doesn't make this letter invalid by any means.
Sincerely,
Raghu
----------------------------------------------------- ------------------------------------------------------- --------
P.S. The excerpts for your reference:
#1
Source: http://neurologicalcorrelates.com/wordpress/2010/09/15/lorcaserin-fraud-and-market-manipulation-nah-clairvoyance-and-speed-reading/#comments
We wonder if a secret FDA document with material, market moving information was selectively released only to large financial people.
How is it that one nanosecond after FDA briefing docs are made public the analysts and msm have articles up on line and ready to go?
Did they take a speed reading class? And, more to the point: why did they have short positions as of about a month ago, before there was any real news to trade on?
----------------------------------------------------- ------------------------------------------------------- --------
#2
Source: http://klljinvestments.blogspot.com/2010/09/arena-panel-set-up-for-failure.html
The panel itself was a complete disappointment and it is sad to see a group such as this one, decide the fate of a drug that by all accounts had very safe results and approvable, clinically significant weight loss. Deputy Director Colman should receive much of the blame. He pre-disposed the panel on how to vote. Colman stressed how it ‘barely met guidelines’ in his briefing document and in the panel discussion. The FDA focused only on the placebo adjusted weight loss and not ever discussing the impressive subgroup that lost at least 10% (I also am disappointed ARNA didn’t spend more time focusing on this.) I think it was Felner maybe who finally called Colman out on it wanting to know if it met efficacy guidelines or not. If categorical weight loss wasn’t enough then why are they even having the meeting? When another panel member asked if it is sometimes better to pass a drug and get more data then recall it later in certain circumstances. Colman’s response was a smug one stating that your name would be forever attached to a drug that you helped approve and then recalled. That makes anyone on the fence, and most of them were, vote no.
----------------------------------------------------- ------------------------------------------------------- --------
DATE:
19 August 2010
FROM:
Eric Colman, MD
Deputy Director
Division of Metabolism and Endocrinology Products (DMEP) Office of Drug Evaluation II Center for Drug Evaluation & Research
U.S. Food & Drug Administration
When gauged by the standards of the Division’s 2007 draft guidance for Developing Products for Weight Management, the mean weight loss associated with the lorcaserin 10 mg QD and BID dose was about 3% greater than the mean weight loss with placebo. Therefore Lorcaserin did not satisfy the guidance’s mean efficacy criterion. However, the lorcaserin 10 mg BID dose did, by a slim margin, satisfy the categorical efficacy criterion.
----------------------------------------------------- ------------------------------------------------------- --------
July 15, 2010
FDA Panel Says 'No' to Weight Loss Drug Qnexa
"When you listen to even the 'no' voters, you got the sense a lot of people had a little bit of hesitancy," FDA Deputy Director for Endocrine Products Eric C. Colman, MD, said in a news conference. "They were not strongly against the drug but had lingering concerns that made them vote 'no.'"
----------------------------------------------------- ------------------------------------------------------- --------
Vivus Plunges Most Ever After U.S. Review of Qnexa
July 16, 2010,
“I was a little surprised that the vote went as it did,” said Eric Colman, the deputy director of the FDA’s Division of Metabolism and Endocrinology Products, in a press briefing after the meeting. He declined to elaborate.
----------------------------------------------------- ------------------------------------------------------- --------
“Lorcaserin did not satisfy the guidance’s mean efficacy criterion,” said Eric Colman,
Lorcaserin only barely satisfied the first criteria, and didn’t meet the second, the agency said.
----------------------------------------------------- ------------------------------------------------------- --------
2010-07-15
VIVUS Confident Though FDA Panel Rejects Qnexa
The FDA is expected to make a final ruling on Qnexa on October 28, 2010. The agency usually follows its panel recommendations but isn't required to. However, they often considers close votes a split decision. Eric Colman, FDA’s deputy director of its metabolic and endocrinology products division said, “"They weren't strongly against the drug but had lingering concerns.”
----------------------------------------------------------------------------------------------------------------------
Arena Pharmaceuticals conference call
May 7th, 2010
Question from Jason Zhang -- BMO Capital Markets
"another question is, umm, you know a couple days ago I went to a your competitors lunch and they were suggesting that the FDA's approval, umm, I guess, hurdle is a working in progress and..you know, the old five percent weight loss as the benchmark, could change
ahhh you know I don't have anything specific because mentioning that I wonder during your dialogue with the FDA is that something you heard could the FDA be using a new benchmark, other than the five percent average weight loss?"
----------------------------------------------------------------------------------------------------------------------
July 16, 2010
FDA Panel Rejects Vivus Obesity Pill Qnexa
Eric Colman, deputy director of the FDA's Division of Metabolism and Endocrinology Products, noted that the agency's current draft guidelines only call for one year of safety data.
He told reporters after the meeting that based on the outcome of Thursday's committee and the upcoming panels for lorcaserin and Contrave, the FDA likely will update that guidance before releasing a final version of the document.
----------------------------------------------------------------------------------------------------------------------
Dr. Jessica Henderson
After Meridia Panel:
"I think that just because we didn't measure the benefits scientifically doesn't mean they don't exist," said Dr. Jessica Henderson of Western Oregon University . "I don't think a consumer's right to have that treatment should be taken away just because the scientists didn't do their job."
http://www.wtop.com/?nid=106&sid=2053842
After Lorcaserin Panel:
"I voted no because there is too much uncertainty about brain and breast tumor development and too much uncertainty about the actual population this drug would be used in," said Dr. Jessica Henderson, of Western Oregon University .
http://www.wtop.com/?nid=106&sid=2052408
---------------------------------------------------------------------------------------------------------------------
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