Arena Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
Wednesday, September 29, 2010
Beavis and ButtHead do AdCom preparations on Lorqess
Beavis: Nice job Butthead on doing the statistical tables on the rat tumor data in the FDA briefing documents for the lorcaserin review panel. That was a stroke of genius to combine the benign mammary tumors with the malignant mammary tumors even though there is no connection between the two other than they both appear in the same anatomical location
Butthead: Thanks Beav. I thought you’d like that. Nothing like the specter of breast cancer to get the panel members riled up. Not to mention the women’s support groups to who this information will be helpfully provided.
Beav: Stroke of genius. You’re not vying for my job are you?
BH: Just following your lead. I read your paragraph from the executive summary on the rat tumor data; you sure you’re okay with that? There are three statements there that aren’t even supported by my combinatorial analyses.
Beav: C’mon Butthead, you’re not getting cold feet on me are you? Which statements are you referring to?
BH: First one says “An excess number of malignant mammary tumors developed in female rats treated with lorcaserin at doses within 7-fold of the proposed clinical dose of 10 mg BID” but the results at that level were clearly nonsignificant.
Beav: I didn’t say anything about significance did I? I just said excess number, and technically there were a handful of extra adenocarcinomas in this group even if it could have happened by chance. What else ya got?
BH: You also wrote “Male rats developed malignant mammary tumors when treated with lorcaserin at doses 17-fold higher than the proposed clinical dose” but there were only two tumors in this group and this in no way approached statistical significance.
Beav: C’mon Butt – I just said “male rats developed” which again is technically true; nobody is going to question whether my summary statements are backed up by statistically significant data. What’s the third concern?
BH: Well there is really only one other statement in the summary tumor paragraph and that one states “lorcaserin-treated rats had an excess number of malignant astrocytomas, squamous carcinomas of the subcutis, and malignant schwannomas.” However, the data for these three tumor types were only significant when the rats were given 55 times the human dose. Don’t you think we should at least acknowledge that and indicate that absolutely no such tumors were seen for all three of these tumor types at 5 times the human dose.
Beav: C’mon grasshopper, don’t get soft on me.
BH: But with all our degrees and years of experience, and fiduciary duty to the public, aren’t we suppose to have a handle on basic concepts like statistical significance and the inappropriateness of mixing apples with oranges?
Beav: Don’t worry about it.
BH: And you have no concerns about violation of 42 CFR 93 – Manipulating research materials, or changing or omitting data or results such that the research is not accurately represented in the research record.
Beav: C’mon now, what are the requirements for making such a determination?
BH: That (a) there be a significant departure from accepted practices of the relevant research community; and (b) the misconduct be committed intentionally, knowingly, or recklessly; and (c) the allegation be proven by a preponderance of the evidence.
Beav: Don’t be overly paranoid. You gonna back my play or not?
BH: Sure, you’re the boss. Remind me again why we hate lorcaserin so much even though it’s demonstrably safer than two other diet drugs that the panel reviewed in the last three months.
Beav: (raising right hand and rubbing thumb and forefinger together). Heh, heh, heh, heh.
(Repost from Yahoo MB, courtesy of CGBlood)
EISAI at Obesity 2010 ASM conference
Booth # 103. I am wondering why Eisai is at this conference, are they going to release BLOOM-DM data?
http://www.afassanoco.com/media/pdf/tos/currentfloorplan.pdf
http://www.afassanoco.com/media/pdf/tos/currentfloorplan.pdf
New PATENT Awarded to ARNA - Combination therapy for the treatment of diabetes and conditions related thereto
Full credit to Suauve9 - my hat tips to his research.
United States Patent 7,803,754
Chu , et al. September 28, 2010
Combination therapy for the treatment of diabetes and conditions
related thereto and for the treatment of conditions ameliorated by
increasing a blood GLP-1 level
Abstract
The present invention concerns combination of an amount of a GPR119
agonist with an amount of a dipeptidyl peptidase IV (DPP-IV) inhibitor
such that the combination provides an effect in lowering a blood
glucose level or in increasing a blood GLP-1 level in a subject over
that provided by the amount of the GPR119 agonist or the amount of the
DPP-IV inhibitor alone and the use of such a combination for treating
or preventing diabetes and conditions related thereto or conditions
ameliorated by increasing a blood GLP-1 level. The present invention
also relates to the use of a G protein-coupled receptor to screen for
GLP-1 secretagogues.
Inventors: Chu; Zhi-Liang (San Diego, CA), Leonard; James N. (San
Diego, CA), Al-Shamma; Hussien A. (Encinitas, CA), Jones; Robert M.
(San Diego, CA)
Assignee: Arena Pharmaceuticals, Inc. (San Diego, CA)
Appl. No.: 11/603,417
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,803,754.PN.&OS=PN/7,803,754&RS=PN/7,803,754
United States Patent 7,803,754
Chu , et al. September 28, 2010
Combination therapy for the treatment of diabetes and conditions
related thereto and for the treatment of conditions ameliorated by
increasing a blood GLP-1 level
Abstract
The present invention concerns combination of an amount of a GPR119
agonist with an amount of a dipeptidyl peptidase IV (DPP-IV) inhibitor
such that the combination provides an effect in lowering a blood
glucose level or in increasing a blood GLP-1 level in a subject over
that provided by the amount of the GPR119 agonist or the amount of the
DPP-IV inhibitor alone and the use of such a combination for treating
or preventing diabetes and conditions related thereto or conditions
ameliorated by increasing a blood GLP-1 level. The present invention
also relates to the use of a G protein-coupled receptor to screen for
GLP-1 secretagogues.
Inventors: Chu; Zhi-Liang (San Diego, CA), Leonard; James N. (San
Diego, CA), Al-Shamma; Hussien A. (Encinitas, CA), Jones; Robert M.
(San Diego, CA)
Assignee: Arena Pharmaceuticals, Inc. (San Diego, CA)
Appl. No.: 11/603,417
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,803,754.PN.&OS=PN/7,803,754&RS=PN/7,803,754
Tuesday, September 28, 2010
Weight-Loss Trial Final Report: 52 Pounds of Fat Melted Away
Ed Susman story and very interesting comments
http://neurologicalcorrelates.com/wordpress/2009/02/20/weight-loss-trial-final-report-52-pounds-of-fat-melted-away/
http://neurologicalcorrelates.com/wordpress/2009/02/20/weight-loss-trial-final-report-52-pounds-of-fat-melted-away/
Monday, September 27, 2010
Thought on Alicia Munday's recent article
This is from Cindy :
Alicia Munday who authored this article also wrote about Restructuring the FDA and another entitled "A Wolfe in Regulators Clothing”:
She also wrote a book called "Dispensing the Truth" - a story about a bride-to-be who died "because" of fen-phen.
This web just keeps getting larger and more entangled. I've gone from having tunnel-vision on Arena and whether rat carcinogenic studies actually have statistical significance and were improperly highlighted by the FDA - along with their obvious bias to: leaked documents; hedge fund or other Wall St. manipulation/control; deep capture; and a new world order. It's mind boggling.
One has to question how much influence any of us has when trying to confront or bring to light the improprieties of entrenched yet questionable or even illegal practices widely accepted on Wall St. and ignored by federal regulators and the media. How can we fight the big money influences Wall St., lobbyists, or the "elite" have on our federal agencies and politicians? How do we right this ship? How do we level the playing field? I don't have the answer to those questions, but know there is power in numbers and somehow those numbers have to join to create a very loud voice.
If only Alicia Munday could join forces with Mark Mitchell of deepcapture ....
Senator Grassley's letter to Obama - Is FDA Corrupt?
Public should decide that, this letter shows how deeply corrupt FDA is.
http://abcnews.go.com/images/Politics/Grassley-letter-FDA.pdf
What actions did the government take, can government fix this problem? What are these Ex. FDA chiefs and executives doing now? working at hedge funds?
Lot of unanswered questions.
http://abcnews.go.com/images/Politics/Grassley-letter-FDA.pdf
What actions did the government take, can government fix this problem? What are these Ex. FDA chiefs and executives doing now? working at hedge funds?
Lot of unanswered questions.
Sunday, September 26, 2010
CDER Ombudsman - BEST Person to complaint about FDA
This is who we all should complaint to
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ContactCDER/CDEROmbudsman/default.htm
Copy from FDA site
The CDER Ombudsman receives and investigates complaints from CDER-regulated industry, law firms, health care providers, and consumers, and informally resolves disputes between those entities and CDER. The Ombudsman advises CDER management about Center program issues. Also, the Ombudsman can assist with resolution of scientific differences of opinion amongst CDER staff. The Ombudsman performs these duties while adhering to the ombudsman principles of ensuring confidentiality, neutrality, and informality.
The Ombudsman makes every effort to respond to all complaints in a timely and effective manner. Upon request, communications with the Ombudsman will be considered confidential.
Mission/Vision
Mission: To quickly and impartially investigate complaints and resolve disputes between CDER and CDER-regulated industry, health care providers, and consumers by offering an informal, confidential, and neutral environment.
Vision: To improve the functionality and transparency of CDER by providing efficient resolution of disputes and by fostering communications with stakeholders.
Non-retaliation policy
The FDA Ombudsman page discusses FDA's position on retaliation.
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ContactCDER/CDEROmbudsman/default.htm
Copy from FDA site
CDER Ombudsman
The CDER Ombudsman, Virginia Behr, will be on extended leave September 1 until December 6, 2010. During that time, Captain Mary Kremzner will be the Acting CDER Ombudsman. You can contact her via email at mary.kremzner@fda.hhs.gov or cderombudsman@fda.hhs.gov or via telephone at 301-796-3144. |
The Ombudsman makes every effort to respond to all complaints in a timely and effective manner. Upon request, communications with the Ombudsman will be considered confidential.
Mission/Vision
Mission: To quickly and impartially investigate complaints and resolve disputes between CDER and CDER-regulated industry, health care providers, and consumers by offering an informal, confidential, and neutral environment.
Vision: To improve the functionality and transparency of CDER by providing efficient resolution of disputes and by fostering communications with stakeholders.
Non-retaliation policy
The FDA Ombudsman page discusses FDA's position on retaliation.
Novel Weight-Loss Pill Helps
Novel Weight-Loss Pill Helps Shed Pounds by Medpagetoday.com, very interesting and unbiased video
http://www.medpagetoday.com/PrimaryCare/Obesity/21166
What is wrong with the system? Manipulation of data by FDA
Excellent post on yahoo MB by "rainbowin1" and a must read for ALL.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=152737&mid=152737&tof=1&frt=2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=152737&mid=152737&tof=1&frt=2
Saturday, September 25, 2010
Petition to U.S Congress by "Citizens of Lorcaserin"
http://www.petitiononline.com/passlorc/petition.html
Dear Readers,
I strongly urge you all to sign the petition put up by "Citizens of Lorcaserin". This is a key in our campaign, let us educate, encourage and rally around this campaign. We can not let hedge funds or FDA deny this novel weight loss drug to the general public. Keeping this drug away from needy patients and doctors is a CRIME and a SIN, let us do our moral duty and support this campaign.
Sincerely,
Versoljobs
Dear Readers,
I strongly urge you all to sign the petition put up by "Citizens of Lorcaserin". This is a key in our campaign, let us educate, encourage and rally around this campaign. We can not let hedge funds or FDA deny this novel weight loss drug to the general public. Keeping this drug away from needy patients and doctors is a CRIME and a SIN, let us do our moral duty and support this campaign.
Sincerely,
Versoljobs
Interview by Medpage Today - Ed Sussman's interview on 50 lb weight loss
Compelling interview by Medpage Today - Ed Sussman's interview on 50 lb weight loss and under control diabetes.
Must watch
http://www.youtube.com/watch?v=lcTNh80quS4&feature=related
Must watch
http://www.youtube.com/watch?v=lcTNh80quS4&feature=related
Thursday, September 23, 2010
The vultures are circling us!
An article on the opportunistic lawyers that are trying to cash in on Arena's difficult situation:
http://www.fiercebiotech.com/story/lawsuits-start-pile-wake-arena-setback/2010-09-23
http://www.fiercebiotech.com/story/lawsuits-start-pile-wake-arena-setback/2010-09-23
FDA to limit AVANIDA access
Is it possible that FDA will approve Lorqess with restrictions? I think there is 15% chance.
http://www.latimes.com/health/la-sci-avandia-20100924,0,7722606.story
http://www.latimes.com/health/la-sci-avandia-20100924,0,7722606.story
USA fattest of 33 countries, FDA doesn't get it
Article in USA Today, everyone gets it but not the FDA.
http://www.usatoday.com/news/health/weightloss/2010-09-24-fatusa24_ST_N.htm?csp=YahooModule_News
http://www.usatoday.com/news/health/weightloss/2010-09-24-fatusa24_ST_N.htm?csp=YahooModule_News
Wednesday, September 22, 2010
Letter to Government by KLLJInvestments
This is a compelling letter written by "klljinvestments". This is a must read and contact Mo to re-purpose the letter
http://klljinvestments.blogspot.com/p/letter-to-government.html
Other recommended content from "klljinvestments"
http://klljinvestments.blogspot.com/2010/09/live-blog-of-lorcaserin-advisory.html
http://klljinvestments.blogspot.com/p/letter-to-government.html
Other recommended content from "klljinvestments"
Live Blog of Lorcaserin Advisory Committee
http://klljinvestments.blogspot.com/2010/09/live-blog-of-lorcaserin-advisory.html
FDA knew about secret Motrin recall??
Courtesy AP and Yahoo finance
http://finance.yahoo.com/news/JampJ-lawyers-FDA-knew-of-apf-2195851970.html?x=0&sec=topStories&pos=9&asset=&ccode=
"The ranking Republican on the oversight committee, Rep. Darrell Issa, R-CA, wrote in an e-mail to The Associated Press, "We need to uncover the true extent of what the FDA knew and when they knew it and determine whether or not they acted appropriately and timely."
http://finance.yahoo.com/news/JampJ-lawyers-FDA-knew-of-apf-2195851970.html?x=0&sec=topStories&pos=9&asset=&ccode=
"The ranking Republican on the oversight committee, Rep. Darrell Issa, R-CA, wrote in an e-mail to The Associated Press, "We need to uncover the true extent of what the FDA knew and when they knew it and determine whether or not they acted appropriately and timely."
My E-mail to Alicia Mundy at WSJ and Jared Favole at DOW
Alicia and Jared,
I write you in hope that someone will investigate what happened prior to ARNA AdCom meeting. Please review e-mail sent to Dr. Margaret Hamburg below. We have started a blog
http://arenadeepcapture.blogspot.com/
Lorcaserin is a novel compound, please expose the TRUE RATs in this case. We are more than willing to provide you with all scientific data in support of Lorqess and why it should be approved, please help us find the answers to why FDA hijacked this panel.
Your help in bringing this story to forefront is much appreciated.
Sincerely,
XXXXXXXX
I write you in hope that someone will investigate what happened prior to ARNA AdCom meeting. Please review e-mail sent to Dr. Margaret Hamburg below. We have started a blog
http://arenadeepcapture.blogspot.com/
Lorcaserin is a novel compound, please expose the TRUE RATs in this case. We are more than willing to provide you with all scientific data in support of Lorqess and why it should be approved, please help us find the answers to why FDA hijacked this panel.
Your help in bringing this story to forefront is much appreciated.
Sincerely,
XXXXXXXX
NEJM questions sale of Meridia
NEJM questions sale of Meridia - "It is difficult to discern a credible rationale for keeping this medication on the market," they wrote.
Credits to Yahoo and AP
http://finance.yahoo.com/news/Journal-editors-question-sale-apf-905590735.html?x=0&.v=2
Credits to Yahoo and AP
http://finance.yahoo.com/news/Journal-editors-question-sale-apf-905590735.html?x=0&.v=2
Finally - SEC May Rein in High-Frequency Trading Firms
Courtesy Bloomberg
http://www.bloomberg.com/news/2010-09-22/schapiro-says-sec-will-weigh-restrictions-on-high-frequency-trading-firms.html
An Excerpt
The SEC is increasingly signaling concern that a surge in computer-based trading, accounting for more than 50 percent of the daily volume in stocks, has outpaced regulation. The agency faces pushback from hedge funds and other financial firms, which say that new rules shouldn’t be imposed without specific evidence that high-frequency trading hurts markets.
The May 6 plunge in stock prices, in which $862 billion was temporarily erased from the value of U.S. equities in less than 20 minutes, has prompted regulators to question whether markets can “handle the high-speed, pre-programmed trading algorithms that generate much of today’s trading volume,” Schapiro said.
http://www.bloomberg.com/news/2010-09-22/schapiro-says-sec-will-weigh-restrictions-on-high-frequency-trading-firms.html
An Excerpt
The SEC is increasingly signaling concern that a surge in computer-based trading, accounting for more than 50 percent of the daily volume in stocks, has outpaced regulation. The agency faces pushback from hedge funds and other financial firms, which say that new rules shouldn’t be imposed without specific evidence that high-frequency trading hurts markets.
The May 6 plunge in stock prices, in which $862 billion was temporarily erased from the value of U.S. equities in less than 20 minutes, has prompted regulators to question whether markets can “handle the high-speed, pre-programmed trading algorithms that generate much of today’s trading volume,” Schapiro said.
Interesting Blog Article on Arena and analysts
The information at the end is specially interesting: The short interest is still 31% at this low price level.
http://www.bloggingstocks.com/2010/09/22/chasing-value-arena-analysts-bad-advice/
http://www.bloggingstocks.com/2010/09/22/chasing-value-arena-analysts-bad-advice/
Short trader feels it is PATRIOTIC to short and KILL a novel compound
So much respect for inventions and intellectual property.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=148935&mid=148935&tof=5&frt=2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1339&tid=148935&mid=148935&tof=5&frt=2
James Hill M.D; calls out FDA panel
James Hill M.D; calls out FDA panel on Sept 21 2010
http://seekingalpha.com/instablog/398853-james-hill-md/94978-fda-panel-flubbed-in-arenas-lorcaserin-disapproval
http://seekingalpha.com/instablog/398853-james-hill-md/94978-fda-panel-flubbed-in-arenas-lorcaserin-disapproval
Tuesday, September 21, 2010
FDA Reviewers don't understand Obesity Drug from Arena
Reuters: FDA Reviewers don't understand Obesity Drug
http://www.reuters.com/article/idUSTRE68G2CF20100917
Proactive Investors:
http://proactiveinvestors.com/companies/news/8497/negative-advisory-committee-vote-on-arena-pharmaceuticals-lorcaserin-does-not-necessarily-mean-that-it-will-not-be-approved-8497.html
http://www.reuters.com/article/idUSTRE68G2CF20100917
Proactive Investors:
http://proactiveinvestors.com/companies/news/8497/negative-advisory-committee-vote-on-arena-pharmaceuticals-lorcaserin-does-not-necessarily-mean-that-it-will-not-be-approved-8497.html
List of contacts for our campaign
Endocrinologic & Metabolic Drugs Advisory Committee Roster:
HHS Employees from Both Advisory Panels (i.e. Meridia and Lorcaserin) –
- Curtis J. Rosebraugh, M.D., M.P.H. (Director) - curtis.rosebraugh@fda.hhs.gov
- Mary H. Parks, M.D. (Director) - mary.parks@fda.hhs.gov
- Eric Colman, M.D. (Deputy Director) - eric.colman@fda.hhs.gov
- Monique Falconer, M.D., M.S. (Clinical Reviewer) - monique.falconer@fda.hhs.gov
- David Hoberman, Ph.D. (Statistician, Div. of Biometrics) - david.hoberman@fda.hhs.gov
- Katherine M. Flegal, Ph.D. - katherine.flegal@cdc.hhs.gov
- Edward W. Gregg, Ph.D. - edward.gregg@cdc.hhs.gov
- Michael A. Proschan, Ph.D. - Michael.Proschan@nih.hhs.gov
- Julie K. Golden, M.D. (Clinical Reviewer) - julie.golden@fda.hhs.gov
- Fred K. Alavi (Pharmacology/Toxicology Reviewer) - fred.alavi@fda.hhs.gov
- Todd M. Bourcier, Ph.D. (Pharmacologist Team Leader) - todd.bourcier@fda.hhs.gov
- David D. Waters, M.D. - David.Waters@nih.hhs.gov
- Dennis O. Dixon, Ph.D. - Dennis.Dixon@nih.hhs.gov
- Paul Tran (Designated Federal Official) - Paul.Tran@fda.hhs.gov
Others from Board -
mary.kremzner@fda.hhs.gov
cderombudsman@fda.hhs.gov
Lynn@cswd.org
Miriam@cswd.org
paffairs@oig.hhs.gov
president@messages.whitehouse.gov
info@messages.whitehouse.gov
karin.nelson@med.va.gov
info@obesityaction.org
jpratt@obesity.org;fdea@obesity.org
hendersj@wou.edu
info@healthadvocate.com
editors@medicalnewstoday.com
walter@obesitylaw.com
kelley@obesitylaw.com
info@nyccah.org
glennbeck@foxnews.com
cavuto@foxnews.com
ontherecord@foxnews.com
sanjay.gupta@turner.com
cderombudsman@fda.hhs.gov
Lynn@cswd.org
Miriam@cswd.org
paffairs@oig.hhs.gov
president@messages.whitehouse.gov
info@messages.whitehouse.gov
karin.nelson@med.va.gov
info@obesityaction.org
jpratt@obesity.org;fdea@obesity.org
hendersj@wou.edu
info@healthadvocate.com
editors@medicalnewstoday.com
walter@obesitylaw.com
kelley@obesitylaw.com
info@nyccah.org
glennbeck@foxnews.com
cavuto@foxnews.com
ontherecord@foxnews.com
sanjay.gupta@turner.com
********Department of Health & Human Sevices (HHS)********
(click on links below for further leadership contact info)
http://www.hhs.gov/open/contacts/index.html#sd
More info on the officials & the leadership flow can be obtained here: http://www.whorunsgov.com/Profiles/Kathleen_Sebelius
- HHS Employee Directory -
http://Dir.y.psc.gov/employee.htm
- Email addresses for officials from the HHS website –
Operating Divisions:
1) Kathleen Sebelius (Secretary of the Dept. HHS) - Kathleen.Sebelius@hhs.gov
(Quote by Sebelius on HHS site - “Our Administration is committed to eliminating the barriers between the American people & their government, & we want to ensure government is open & accountable to you.”)
à TAKE NOTICE of “Accountability”
2) William V. Corr, J.D. (Deputy Secretary HHS) – email N/A
3) Laura Petrou ( Chief of Staff HHS) - COS_info@hhs.gov
4) Dawn L. Smalls (Executive Secretary) - Dawn.Smalls@hhs.gov
5) Oliver Potts (Dir., Office of Documents & Regulations Management HHS) - Oliver.Potts@hhs.gov
6) Counselors to the Secretary - Counselors@hhs.gov
a. Rima Cohen - Counselors to the Secretary for Health Policy
b. Dora L. Hughes, M.D., M.P.H., F.A.C.P. - Counselor for Science & Public Health
c. Sharon Parrott - Counselor to the Secretary for Human Services Policy
7) Margaret A. Hamburg M.D. (FDA Cmsr.)- Margaret.Hamburg@fda.hhs.gov
8) Kathy Greenlee (Assistant Secretary for Aging) - Kathy.Greenlee@aoa.hhs.gov
9) Mary K. Wakefield, Ph.D., R.N. (Administrator HRSA) - Administrator@hrsa.gov
10) Carolyn M. Clancy, M.D. (Agency for Healthcare Research & Quality) - Dir.@ahrq.hhs.gov
11) Thomas Frieden M.D. (Dir. CDC, Administrator Agency for Toxic Substances & Disease Registry) - Tomfrieden@cdc.gov
12) Francis S. Collins, M.D., Ph.D. (Dir., National Institutes of Health (NIH)) - execsec1@od.nih.gov
13) Daniel R. Levinson (Inspector General, Office of Inspector General) - paffairs@oig.hhs.gov
14) Dr. Donald M. Berwick Administrator, (Ctr.s for Medicare & Medicaid Services) - AskCMSquestions@cms.hhs.gov
------FDA –--------
List of FDA Leadership Profiles:
http://www.fda.gov/AboutFDA/Ctr.sOffices/ucm193757.htm
1) Margaret A. Hamburg M.D. (FDA Cmsr.)- Margaret.Hamburg@fda.hhs.gov
2) Joshua M. Sharfstein, M.D. (Principal Deputy Cmsr.) - joshua.sharfstein@fda.hhs.gov
3) Russell Abbott (Deputy Cmsr. for Administration) - russell.abbott@fda.hhs.gov
4) David Dorsey, J.D. (Acting Deputy Cmsr. for Policy, Planning, & Budget) - david.dorsey@fda.hhs.gov
5) Murray M. Lumpkin, M.D.(Deputy Cmsr. for International Programs) - murray.lumpkin@fda.hhs.gov
6) Ralph S. Tyler, J.D. (Chief Counsel) - ralph.tyler@fda.hhs.gov
7) John M. Taylor III, J.D.(Counselor to the Cmsr.) - john.taylor2@fda.hhs.gov
8) Jeanne Ireland (Assistant Cmsr. for Legislation) - jeanne.ireland@fda.hhs.gov
9) Michael A. Chappell (Acting Associate Cmsr. for Regulatory Affairs) - michael.chappell@fda.hhs.gov
10) Beth Martino (Associate Cmsr. for External Affairs) - beth.martino@fda.hhs.gov
11) Lawrence R. Deyton, M.S.P.H., M.D. (Dir., Ctr. for Tobacco Products) - lawrence.deyton@fda.hhs.gov
12) Bernadette Dunham, D.V.M., Ph.D.(Dir., Ctr. for Veterinary Medicine) - bernadette.dunham@fda.hhs.gov
13) Michael M. Landa, J.D. (Acting Dir., Ctr. for Food Safety & Applied Nutrition) - michael.landa@fda.hhs.gov
14) Karen Midthun, M.D. (Dir., Ctr. for Biologics Evaluation & Research) - karen.midthun@fda.hhs.gov
15) Jeffrey E. Shuren, M.D., J.D.(Dir., Ctr. for Devices & Radiological Health) - jeff.shuren@fda.hhs.gov
16) William Slikker, Jr., Ph.D. (Dir., National Ctr. for Toxicological Research) - william.slikker@fda.hhs.gov
17) Janet Woodcock, M.D (Dir., Ctr. for Drug Evaluation & Research) - janet.woodcock@fda.hhs.gov
18) FDA Ctr. for Drug Evaluation & Research (CDER):
- Contact FDA Ctr. for Drug Evaluation & Research (CDER) – (Fill out form on Site)
“Information about drug products currently in review at FDA is confidential. If you know the manufacturer/sponsor, please contact them directly.
http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm
19) Cardiovascular & Renal Drugs Advisory Committee:
Elaine Ferguson, M.S., R.Ph., (Designated Federal Official) - Elaine.Ferguson@fda.hhs.gov
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/default.htm
20) Office of Compliance - “Vision: Through excellence in risk- and science-based policy, surveillance, and enforcement, we prevent consumer exposure to unnecessary risk from drugs throughout their lifecycle.”
- Deborah Autor, Esq., Director (FDA Office of Compliance) - deborah.autor@fda.hhs.gov
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Rm 5271
Silver Spring, MD 20993-0002
21) Office of New Drugs - “Our Mission - To ensure that safe and effective drugs and biologics are available to the American people.”
- John Jenkins, M.D., Director (Office of New Drugs) - john.jenkins@fda.hhs.gov
- Sandra Kweder, M.D., Deputy Director (Office of New Drugs) - sandra.kweder@fda.hhs.gov
Office of New Drugs
301-796-0700
Fax: 301-796-9856
ondeio@fda.hhs.gov
Immediate Office - Mail Stop 6311
10903 New Hampshire Avenue
Silver Spring, MD 20993
22) Office of Oncology Drug Products Divisions & Programs:
- Richard Pazdur, M.D. - Dir., Div. of Oncology Drug Products - richard.pazdur@fda.hhs.gov
Food & Drug Administration
Ctr. for Drug Evaluation & Research
Division of Drug Oncology Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
23) Division of Drug Oncology Products (DDOP)
- Robert Justice, M.D.(Director) - robert.justice@fda.hhs.gov
- Ann Farrell, M.D. (Deputy Director) - ann.farrell@fda.hhs.gov
- Anthony Murgo, M.D. (Acting Deputy Director) - anthony.murgo@fda.hhs.gov
- Amna Ibrahim, M.D. (Deputy Director of Safety) - amna.ibrahim@fda.hhs.gov
Co-Chiefs, Project Management Staff:
- Frank Cross - frank.crossjr@fda.hhs.gov
- Alice Kacuba, R.N., M.S.N. - alice.kacuba@fda.hhs.gov
Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Oncology Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
24) Office of Pharmaceutical Science (OPS)
- Helen N. Winkle, (Director) - helen.winkle@fda.hhs.gov
- Keith O. Webber, Ph.D. (Deputy Director) - keith.webber@fda.hhs.gov
25) Office of New Drug Quality Assessment
- Moheb Nasr, Ph.D. (Director) - moheb.nasr@fda.hhs.gov
- Christine Moore, Ph.D. (Acting Deputy Director) - christine.moore@fda.hhs.gov
10903 New Hampshire Avenue HFD-800
Silver Spring, MD 20993
Phone: (301) 796-1900
Fax: (301) 796-9748
26) Office of Biotechnology Products (OBP)
"The mission of the Office of Biotechnology Products is to protect public health by assuring the quality, safety, efficacy, availability and security of therapeutic protein and monoclonal antibody products."
- Steve Kozlowski, M.D. (Director) - steven.kozlowski@fda.hhs.gov
27) Office of Testing and Research Mission
- Vincent L. Vilker, Ph.D. (Director) - vincent.vilker@fda.hhs.gov
The mission of the Office of Testing and Research is to:
* Advance the scientific basis of regulatory policy
* Assure that regulatory policy and decision making are based on the best available science
Federal Research Center
White Oak Office Building #22
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-1213 Fax: (301) 796-9859
28) Division of Pharmaceutical Analysis
- Lucinda Buhse, Ph.D. (Director) - lucinda.buhse@fda.hhs.gov
Benjamin Westenberger, Deputy Director
1114 Market St. Room 1002
St. Louis, Missouri 63101
Phone: (314) 539-2135 Fax: (314) 539-2113
29) Office of Translational Sciences
- Shaavhree Buckman, MD, PhD (Acting Director) - shaavhree.buckman@fda.hhs.gov
Overview - "OTS was established to promote efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety, and dosing of drugs through collaboration among the Office of Biostatistics, Office of Clinical Pharmacology, and other offices in CDER and Centers in FDA. We foster novel drug development strategies through research and application of statistical and mathematical modeling and simulation techniques in the review and analysis of data in the areas of exposure-response, pharmacokinetics, pharmacodynamics, pharmacogenomics, bioequivalence assessment, clinical trials, quantitative risk assessment, toxicology, and product quality assessment."
White Oak Building 22 - Room 5300
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: 301-796-2600
Fax: 301-796-9907
29) Office of Biostatistics Organization
(http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm166250.htm)
- Robert T. O'Neill, PhD, (Director) - robert.oneill@fda.hhs.gov
- S. Edward Nevius, PhD, (Deputy Director) - sedward.nevius@fda.hhs.gov
- Sue-Jane Wang, PhD, (Associate Director, Pharmacogenomics) - suejane.wang@fda.hhs.gov
- Ram Tiwari, PhD, (Associate Director) - ram.tiwari@fda.hhs.gov
- George Rochester, PhD, (Acting Associate Director) - george.rochester@fda.hhs.gov
*****Public Advocates*******
Below are links to public advocates that need to be informed of the FDA & Advisory Panels questionable actions.
1) The Obesity Society (!!!Meeting in SanDiego Oct 8-12!!!)
http://www.obesity.org/
2) Obesity Action Coalition
http://www.obesityaction.org/advocacy/ge...
3) Council on Size & Weight Discrimination
http://www.cswd.org/
4) New York City Coalition Against Hunger (a must read report)
http://www.nyccah.org/node/92
5) Health Advocate
http://www.healthadvocate.com/
http://www.medicalnewstoday.com/articles...
6) British Columbia Association of Bariatric Advocates
http://www.bcaba.net/
7) Obesity Law & Advocacy Ctr.
http://www.obesitylaw.com/lawyers.php
1) The Obesity Society (!!!Meeting in SanDiego Oct 8-12!!!)
http://www.obesity.org/
2) Obesity Action Coalition
http://www.obesityaction.org/advocacy/ge...
3) Council on Size & Weight Discrimination
http://www.cswd.org/
4) New York City Coalition Against Hunger (a must read report)
http://www.nyccah.org/node/92
5) Health Advocate
http://www.healthadvocate.com/
http://www.medicalnewstoday.com/articles...
6) British Columbia Association of Bariatric Advocates
http://www.bcaba.net/
7) Obesity Law & Advocacy Ctr.
http://www.obesitylaw.com/lawyers.php
Links for Poeple to contact there senators: | |
https://writerep.house.gov/writerep/welcome.shtml | |
http://www.senate.gov/general/contact_information/senators_cfm.cfm |
Letter to Commisioner of FDA, Margaret Hamburg, M.D.
Sept 20, 2010
Margaret Hamburg, M.D.
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.
Margaret Hamburg, M.D.
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? This 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,
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? This 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,
Versoljobs
To: margaret.hamburg@fda.hhs.gov CC: mary.parks@fda.hhs.gov; eric.colman@fda.hhs.gov; curtis.rosebraugh@fda.hhs.gov; john.jenkins@fda.hhs.gov; janet.woodcock@fda.hhs.gov; mary.kremzner@fda.hhs.gov; cderombudsman@fda.hhs.gov; Lynn@cswd.org; Miriam@cswd.org; paffairs@oig.hhs.gov; president@messages.whitehouse.gov; info@messages.whitehouse.gov; karin.nelson@med.va.gov; info@obesityaction.org; jpratt@obesity.org; fdea@obesity.org; hendersj@wou.edu; info@healthadvocate.com; editors@medicalnewstoday.com; walter@obesitylaw.com; kelley@obesitylaw.com; info@nyccah.org; glennbeck@foxnews.com; cavuto@foxnews.com; ontherecord@foxnews.com; sanjay.gupta@turner.com; dnllpz33@gmail.com
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