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Health
See other Health Articles

Title: From The Fraud And Death Administration's (FDA) Own Website
Source: FDA
URL Source: http://www.fda.gov/Drugs/Developmen ... ractionsLabeling/ucm114848.htm
Published: May 19, 2012
Author: Some Criminal
Post Date: 2012-05-19 14:36:51 by Original_Intent
Ping List: *Agriculture-Environment*     Subscribe to *Agriculture-Environment*
Keywords: FDA, Fraud, Death, Dishonesty
Views: 180
Comments: 19

Why Learn about Adverse Drug Reactions (ADR)?

Institute of Medicine, National Academy Press, 2000

Lazarou J et al. JAMA 1998;279(15):1200–1205

Gurwitz JH et al. Am J Med 2000;109(2):87–94

 


Poster Comment:

Until the Ministry of Truth gets to it here are the numbers from the FDA's own website.Subscribe to *Agriculture-Environment*

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#1. To: Original_Intent (#0)

this why there is a revolving door between the FDA heads and big pharma.


If either Moromney or Mammyjammyobammy win the November (s)election peoples with common sense will pray that December 21 2012 will indeed be the end of the world!

IRTorqued  posted on  2012-05-19   14:57:09 ET  Reply   Trace   Private Reply  


#2. To: Original_Intent (#0)

The Adverse Drug Reactions (ADRs) are (1) not all in the US; a great many occur in foreign countries, sometimes with medications that have not yet been approved by the FDA for marketing in the US (one such was Thalidomide - whose dangerous qualities were detected by an FDA researcher even as the manufacturer was paying off politicians to pressure the FDA to approve it as an aspirin substitute), and (2) not all ended in death or even very serious symptoms - a great many simply result in rashes, nausea, constipation and the like.

It is not always possible to detect ADRs when the drug is still in the experimental or pre-approval stage; to that time it has been used by only a limited number of people, frequently under a doctor's close supervision, frequently without uncommon sensitivities or unusual medical histories, etc. Some drawbacks to drugs become apparent only when a very large population is taken them under more random circumstances. Many drugs - there was an arthritis medication only a few years back - have been pulled off the market because of ADRs that were not seen in the pre-approval demographic of users.

Shoonra  posted on  2012-05-19   16:47:27 ET  Reply   Trace   Private Reply  


#3. To: Shoonra (#2)

A sterling attempt to create an ambiguity where none exists.

1 life would be too many when it is created by the revolving wheel of corruption which is the FDA.

Attempts to obfuscate are, per your usual, nothing more than an apologia for criminals.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   17:05:23 ET  Reply   Trace   Private Reply  


#4. To: Original_Intent (#0)

Fraud and Death Administration's (FDA)

Psychiatry and "Mental Health" are all about power, money and politics, not about health and medicine.

2ndoutlawpsychiatry.blogspot.com< /a>

sizzlerguy  posted on  2012-05-19   17:18:24 ET  Reply   Trace   Private Reply  


#5. To: sizzlerguy (#4)

Psychiatry and "Mental Health" are all about power, money and politics, not about health and medicine.

A-Greed.

It is about money and control. The last thing on their mind is actually helping people. One of the more instructive lessons from my personal experience was with a female dentist in the service - she could not understand why her ex-husband, a military Psychiatrist, had gone out of his way to torture and torment her mentally. Most people do not get that not all people, regardless of education, mean well toward others. Some are quite twisted and carry a sick hidden hate of others and unfortunately a lot of that type become Psychiatrists.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   17:28:14 ET  Reply   Trace   Private Reply  


#6. To: Original_Intent, shoonra (#3)

1 life would be too many when it is created by the revolving wheel of corruption which is the FDA.

Let's just outlaw all drugs then, since 1 life would be too many, according to you.

Have fun at the dentist, next time. lol

And surgery? Maybe they'll give you a stick to bite on, since general anesthesia does carry a risk of death.

Better hope that infection doesn't get bad. Things can go downhill fast when you see a red streak working it's way to the heart.

------------------------------------------

"Those who believe the Bible are those who know the least about it".

Thomas Paine (1737-1809), author and reformer

PSUSA2  posted on  2012-05-19   17:33:04 ET  Reply   Trace   Private Reply  


#7. To: PSUSA2 (#6)

I see your reading comprehension problem is giving you trouble again.

1 life would be too many when it is created by the revolving wheel of corruption which is the FDA.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   17:36:20 ET  Reply   Trace   Private Reply  


#8. To: Original_Intent (#7)

the revolving wheel of corruption which is the FDA.

I read just fine.

You say Revolving Wheel Of Corruption = FDA. The FDA is totally corrupt according to what YOU said. Therefore all decisions by that totally corrupt FDA are not just worthless, but intentionally harmful (because it's totally corrupt, right?) because it results in some people dying. Well, people die. The FDA is not there to prevent people from ever dying.

You are not going to get one past me. lol. You just not that good.

But I understand why you accuse them of total corruption. That's because everyone there would have to be In On It.

------------------------------------------

"Those who believe the Bible are those who know the least about it".

Thomas Paine (1737-1809), author and reformer

PSUSA2  posted on  2012-05-19   18:11:16 ET  Reply   Trace   Private Reply  


#9. To: Original_Intent, christine (#5)

Psychiatry and "Mental Health" are all about power, money and politics, not about health and medicine.

A-Greed.

You do know that Christine's husband is either a clinical psychologist or a psychiatrist. I forget which one.

So, he is evil incarnate. Who'd a thunk it.

You are taking that Xenu crap way too seriously.

------------------------------------------

"Those who believe the Bible are those who know the least about it".

Thomas Paine (1737-1809), author and reformer

PSUSA2  posted on  2012-05-19   18:17:26 ET  Reply   Trace   Private Reply  


#10. To: PSUSA2 (#8)

 

Revolving door between the US Government and Industry

February, 2006
Version 3

This page highlights the revolving door between U.S. government agencies, the U.S. Congress, and the pharmaceutical industry. The following former government officials now work at IFPMA, PhRMA, or law firms and lobbying firms that represent the pharmaceutical industry. The information on clients represented by the following individuals is heavily indebted to the Center for Responsive Politics website.

Corrections or suggestions to Mike Palmedo mpalmedo@cptech.org.


 
 
  

The Players

Government Employer 

Private Sector Employer

 Client(s) Represented

  Justin McCarthy  

  USTR - Assistant USTR for Congressional Affairs  

  Pfizer, Assistant Director of Government Relations  

   

  Billy Tauzin  

  U.S. Congress 

  PhRMA, President  

   

  Claude Burcky  

  USTR  

  Abbott Laboratories,  

   

 Sean Darragh  

  USTR  

 Biotechnology Industry Organization,
PhRMA 

  .  

 Randall L. Tobias  

  White House - Global AIDS Coordinator
 

 Eli Lilly 

  .  

  Michael Friedman

  Food and Drug Administration, Acting Commissioner

  PhRMA
Pharmacia

 

  Donald Rumsfield  

  Secretary of Defense
 

 Gilead,
G. D. Searle  

  .  

  Deborah Steelman 

  White House Budget Director
Advisor to George W. Bush campaign,
President Bush Sr.'s Chairman of the Quadrennial Advisory Council on Social Security and Medicare,

White House staff position in Reagan administrations 

  Eli Lilly,
Steelman Health Industries

Aetna
American Home Products
Bristol Myers Squib
Health Industry Manufacturers Association
Humana

Johnson and Johnson
Pfizer
PhRMA

  Mitchell Daniels Jr. 

  Director, Office of Management and Budget 

  Eli Lilly

.
  Raymond V. Gilmartin 

  Bush Transition Team for the Department of Health and Human Services 

  Merck

.
  Anne Marie Lynch 

  Bush Transition Team for the Department of Health and Human Services 

 PhRMA

.
  Bill Walters 

  Bush Transition Team for the Department of Health and Human Services 

 PhRMA

.
 Gerald J. Mossinghoff 

  Assistant Secretary of Commerce, Commissioner of Patents and Trademarks 

 Oblon, Spivak, McClelland, Maier & Neustadt.

 PhRMA
 Dr. Harvey E. Bale, Jr

 USTR 

 IFPMA

.
 Alan F. Holmer 

 Deputy Assistant to the President for Intergovernmental Affairs, Deputy Assistant Secretary for Import Administration-Commerce Department, General Counsel-USTR, Deputy U.S. Trade Representative  

 PhRMA 

.
 Susan K. Finston 

 State 

 PhRMA

 .

 Daniel L. Spiegel 

 US Permanent Representative to the  U.N., State, Legislative Assistant to Senator Hubert Humphrey and Senator Alan Cranston  

 Akin, Gump, Strauss, Hauer & Feld, L.L.P.

 American Home Products

 Donald C. Alexander

 Commissioner of Internal Revenue,  Department of the Interior

 Akin, Gump, Strauss, Hauer & Feld, L.L.P.

 Johnson & Johnson

 S. Bruce Wilson 

 Assistant U.S. Trade Representative for Intellectual Property, Services and Investment, Assistant U.S. Trade Representative for Industry and Services, Staff Director-Subcommittee on Trade (House), Democratic Trade Counsel-Subcommittee on Trade (House)

 Akin, Gump, Strauss, Hauer & Feld, L.L.P.

 American Home Products
 Edward J. Allera

 FDA

 Akin, Gump, Strauss, Hauer & Feld, L.L.P.

 Johnson & Johnson

 Frank J. Donatelli

 USAID, Deputy Assistant to President Reagan for Public Liaison, Assistant to President Reagan for Political and Intergovernmental Affairs

 Akin, Gump, Strauss, Hauer & Feld, L.L.P.

 Johnson & Johnson

 Barney J. Skladany, Jr.

 Department of Justice

 Akin, Gump, Strauss, Hauer & Feld, L.L.P.

 Johnson & Johnson, Warner-Lambert

 Thaddeus J. Burns 

 USPTO, U.S. Intellectual Property Attach�-USTR, Geneva 

 Akin, Gump, Strauss, Hauer & Feld, L.L.P

.
 Elizabeth A. Hyman

 Special Assistant to Attorney General Janet Reno, Associate Counsel to Vice President Al Gore, Assistant Counsel-USTR,

 Akin, Gump, Strauss, Hauer & Feld, L.L.P

 American Home Products
 Howard H. Baker, Jr. Senator (R-Tennessee), Chief of Staff to President Reagan Baker, Donelson, Bearman & Caldwell Schering-Plough
 J. Keith Kennedy

 Staff Director of the Committee on Appropriations for Senator Mark O. Hatfield (R-Oregon)  Baker, Donelson, Bearman & Caldwell PhRMA, Schering-Plough
 George C. Montgomery U.S. Ambassador to Oman, Counsel to Senate Majority Leader Sen. Howard H. Baker (R-Tennessee), Legislative Staffer for Sen. Baker Baker, Donelson, Bearman & Caldwell

 Schering-Plough
 John C. Tuck Under Secretary-Department of Energy, Assistant to President Reagan, Deputy Assistant to the President for Legislative Affairs, Executive Assistant to the Chief of Staff Baker, Donelson, Bearman & Caldwell Schering-Plough
 Peter Barton Hutt  Chief Counsel-FDA Covington & Burling PhRMA, Nonprescription Drug Manufacturers Association
 Bruce N. Kuhlik  Department of Justice Covington & Burling Merck, PhRMA, and Nonprescription Drug Manufacturers Association
 Jeanne S. Archibald

 General Counsel-Department of Treasury, USTR Hogan & Hartson, L.L.P. PhRMA
 Stephan E. Lawton Chief Counsel of the Subcommittee on Health and the Environment of the United States House of Representatives Hogan & Hartson, L.L.P.

 Amgen, Genentech
 Robert P. Brady Associate Chief Counsel for Biologics-FDA, Executive Assistant to the Commissioner of the Food and Drug Administration Hogan & Hartson, L.L.P. Genentech
 Michael R Pollard Federal Trade Commission Michaels & Bonner, P.C Merck
 Thomas D. Parry

 Chief of Staff and Chief Counsel to Senator Orrin G. Hatch (R-Utah)

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, Hoffman- LaRoche, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer, PhRMA,  Pharmacia & Upjohn, Schering-Plough,  and SmithKline Beecham

 Romano Romani

 Legislative Director and Staff Director for Senator Vance Hartke (D-Indiana) and Senator  Dennis DeConcini (D-Arizona)

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, Hoffman- LaRoche, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto, 

Pfizer, PhRMA,  Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham

 Dennis DeConcini

 Senator (D-Arizona)

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer, Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham
 Edward H. Baxter

 Department of the Interior, Chief  Counsel and Staff Director to the Subcommitte on Patents, Copyrights, and Trademarks, Counsel to Senate Judiciary Committee

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, Hoffman- LaRoche, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer, PhRMA,  Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham

 Jack W. Martin

 FDA

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer,  Pharmacia & Upjohn, Schering-Plough,  and SmithKline Beecham

 Linda A. Skladany

  OSHA, Special Assistant to President Reagan, Deputy Director of the White House Office of Public Liaison, Department of Transportation,Department of Education

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome,  Hoechst Marion Roussel, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer, Pharmacia

& Upjohn, Schering-Plough, and SmithKline Beecham

 Shannon S. Davis

 Legislative Assistant to Congressman Sam Johnson (R-TX)

 Parry and Romani Associates

 Abbott, American Home Products, Bristol- Myers Squibb, Hoechst Marion Roussel, Hoffman- LaRoche, Interneuron Pharmaceuticals, Metagenics, Monsanto,  Pfizer, Pharmacia & Upjohn, Schering-Plough, 

and SmithKline Beecham

 Judith A. Butler

 Chief of Staff to three former Republican Members of Congress

 Podesta.com

 Genentech, Genzyme
 Elizabeth A. Inadomi

 Staff Counsel to the U.S. Senate Committee on Commerce, Science and Transportation, Counsel to the U.S. House Subcommittee on Space

 Podesta.com

 Genentech, PhRMA
 Claudia James

 Senior Legislative Assistant to Congressman Peter Peyser, Judiciary Legislative Assistant to Congressman Chris Dodd.

 Podesta.com

 Genentech, PhRMA
 Drew Littman

 Former policy director to Senator Barbara Boxer (D-California)

 Podesta.com

 Genentech, PhRMA
 Anthony Podesta

 Counsel to Senator Edward M. Kennedy (D-Massachusetts), Assistant U.S. Attorney for the District of Columbia

 Podesta.com

 Genentech, Genzyme, PhRMA
 Lee Skillington 

 USPTO 

 Powell, Goldstein, Frazer, & Murphy LLP

 PhRMA
 Jeffrey Kushan 

 USPTO, USTR 

 Powell, Goldstein, Frazer, & Murphy LLP

 Merck
 Barry B. Direnfeld 

 Chief Legislative Counsel to Sen. Howard M. Metzenbaum (D-Ohio), Chief Counsel and Staff Director of the Senate Judiciary Committee's Subcommittee on Antitrust, Monopolies, and Business Rights 

 Swidler Berlin Shereff Friedman LLP 

 Transkaryotic Therapies

 Lester S. Hyman 

 U.S. Securities & Exchange Commission, the U.S. Department of Housing and Urban Development, Secretary of Commerce,Chairman of the Democratic Party of Massachusetts 

 Swidler Berlin Shereff Friedman LLP 

 Schering-Plough, SmithKline Beecham

 H.P. Goldfield 

 Assistant Secretary of Commerce for Trade Development, Associate Counsel to the President, Assistant Counsel-White House 

 Swidler Berlin Shereff Friedman LLP 

 SmithKline Beecham, Transkaryotic Therapies

 Richard A. Popkin  

 Deputy for Policy to the Assistant Secretary of Commerce for Trade Administration 

 Swidler Berlin Shereff Friedman LLP 

 SmithKline Beecham

 Gary D. Slaiman 

 Chief counsel and Staff director for the U.S. Senate Labor and Human Resources Subcommittee on Labor, Counsel to the Senate Judiciary Subcommittee on Antitrust 

 Swidler Berlin Shereff Friedman LLP 

 Transkaryotic Therapies


 


Billy Tauzin

Government Employer As a Member of the House of Representatives (R-LA), Billy Tauzin was the Chairman of the powerful House Energy and Commerce Committee. This committee was heavily involved in drafting the medicare drug benefit

Private Sector Employer

In January 2005, he became President of PhRMA

Source: PhRMA Press Release, - and Tauzin Changes Sides, editorial in Newsday, January, 2005.


Justin McCarthy

Government Employer

Assistant USTR for Congressional Affairs

Private Sector Employer

Since 2003, Mr. McCarthy has served as Director of Government Relations for Pfizer. Prior to that, he was Assistant Director of Government Relations (2001-2003). During his time at Pfizer, Mr. McCarthy was responsible for international trade, intellectual property and tax issues. In addition to his corporate responsibilities, Mr. McCarthy served as Co-Chair of the Business Coalition for U.S.-Central America Trade which was charged with ensuring Congressional approval of DR-CAFTA.

Source: PhRMA press release


Claude Burcky

Government Employer

USTR, Assistant USTR for Intellectual Property

Private Sector Employer

Abbott Laboratories, Director of Global Government Affairs

Source: John Garnaut and Marian Wilkinson. Plum Jobs for US Trade Deal Advisors. Sydney Morning Herald July 2004.


Sean Darragh

Government Employer

Sean Darragh was a Principal Negotiator at the Office of U.S. Trade Representative where he managed the agricultural and life sciences division. He was Principal Deputy Assistant Secretary of Defense at the Pentagon, where he oversaw export policies into Latin America.

Private Sector Employer

Deputy Vice President of International Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA) where he led advocacy, alliance development and public affairs initiatives in the United States and abroad on intellectual property and WTO matters. He left PhRMA in 2003 to join the Biotechnology Industry Organization as the Executive Director for BIO�s Food and Agriculture section.

Source: BIO press release


Randall L. Tobias

Government Employer

Randall Tobas is the first United States Global AIDS Coordinator. This position is part of the Department of State, and carries the rank of Ambassador. On January 19, 2006 he was nominated to the position of Director of United States Foreign Assistance, and he is awaiting confirmation.

Private Sector Employer

From 1993 - 1999, Randall Tobias was President, Chairman and CEO of Eli Lilly.

Source: Department of State Bio.


Donald Rumsfield

Government Employer

Donald Rumsfield is President Bush's Secretary of Defense. During the Ford Administration, he held the post of White House Cheif of Staff (1974-75) and then he became Ford's Secretary of Defense (1975-77).

Private Sector Employer

From 1977 to 1985 he served as Chief Executive Officer, President, and then Chairman of G.D. Searle & Co. From 1993 to 2000, he was Chairman of Gilead Sciences.

Source: Department of Defense Bio.


Michael Friedman

Government Employer

Dr. Michael Friedman was the Acting Commissioner of the FDA from 1997-1998. He is also a reservist in the Public Health Service, where he once had the rank of Rear Admiral and Assistant Attorney General.

Private Sector Employer

Dr. Michael Friedman is a Senior Vice President of the Pharmacia Corporation. He is also PhRMA's Chief Medical Officer for Biomedical Preparedness.

Source: PhRMA Press Release.


Mitchell Daniels Jr.

Government Employer

Mr. Daniels has been named by President Bush to head the Office of Management and Budget. In the past, he has worked as a senior advisor to Senator Richard Lugar and President Reagan.

Private Sector Employer

Mr. Daniels joined Eli Lilly in 1990. In 1993 he became the company's president of North American pharmaceutical operations. In 1997, he was named senior vice president of corporate strategy and policy. Before joining Eli Lilly, he was the president and CEO of the Hudson Institute.

Source: Eli Lilly Press Release: Daniels named to Bush Cabinet-Level Post. Dec. 22, 2000.


Raymond V. Gilmartin

Government Employer

Mr. Gilmartin was appointed to the Bush/Cheney transition team for the Department of Healthand Human Services.

Private Sector Employer

Mr. Gilmartin joined Merck in 1976, starting as the vice president of strategic planning. In 1994 he was named Chairman and CEO. Prior to his employment at Merck, he was Chairman and CEO of Becton Dickinson. Mr. Gilmartin is the current chairman of the Healthcare Institute of New Jersy and of the Valley Health System, Inc., as well as a former chairman of PhRMA. He is chairman of the Council on Competitiveness and is on the board of associates of the Harvard Business School. He is a director of The College Fund/UNCF, and a member of the Business Roundtable, the Business Council. He also sits on the boards of directors of General Mills, Inc. and the Public Service Enterprise Group, Inc.

Source: Merck Bio.


Gerald J. Mossinghoff

Government Employer

Mr. Mossinghoff was a former Assistant Secretary of Commerce and Commissioner of Patents and Trademarks under the Reagan administration from 1981 to 1985. Mr. Mossinghoff claims he advised President Reagan on the establishment of the Court of Appeals for the Federal Circuit. Mr. Mossinghoff represented the United States as Ambassador to the Diplomatic Conference on the Revision of the Paris Convention and as Chairman of the General Assembly of WIPO.

Private Sector Employer

Mr. Gerald J. Mossinghoff is currently Senior Counsel for the law firm of Oblon, Spivak, McClelland, Maier & Neustadt. In 1998, Mr. Mossinghoff was a registered lobbyist for PhRMA. Prior to joining Oblon Spivak, Mr. Mossinghoff joined the Pharmaceutical Manufacturers Association (PMA- now PhRMA) in 1985, as president.

Source:

Oblon Spivak Attorney Locator


Dr. Harvey E. Bale, Jr.

Government Employer

Dr. Harvey E. Bale, Jr. worked at the United States Trade Representative (USTR) for twelve years.

Private Sector Employer

Dr. Harvey E. Bale, Jr. is currently Director-General of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). IFPMA is headquartered in Geneva, Switzerland and represents research-based pharmaceutical companies worldwide. Prior to his career at IFPMA, Harvey Bale was the Senior Vice-President of the Pharmaceutical Research and Manufacturers of America (PhRMA); he joined PhRMA in 1989.

Source: IFPMA Press Release, August 5, 1997 (http://www.pharmweb.net/pwmirror/pw9/ifpma/ifpma9.html)


Alan F. Holmer

Government Employer

Mr. Alan F. Holmer worked at USTR from 1985 to 1989. From 1985 to 1987, Alan Holmer served as General Counsel to U.S. Trade Representative Clayton Yeutter. From 1987 to 1989 Mr. Holmer served as the Deputy U.S. Trade Representative (with rank of Ambassador). Prior to joining USTR, Mr. Holmer served as the Deputy Assistant Secretary for Import Administration at the Commerce Department from 1983 to 1985. As an appointee of President Reagan, Mr. Holmer served as Deputy Assistant to the President for Intergovernmental Affairs from 1981 to 1983.

Private Sector Employer

Alan F. Holmer is the President and C.E.O of PhRMA, a position he has held since July 1996. PhRMA is headquartered Washington, D.C. and represents America's research-based pharmaceutical and biotechnology corporations. Click here to view Mr. Holmer's letter (January 18, 2000) to Secretary Donna Shalala expressing PhRMA's displeasure with the WHO's draft resolution on HIV/AIDS. Prior to his tenure at PhRMA, Mr. Holmer worked at the law firm of Sidley & Austin; he joined Sidley & Austin in 1989.

Source: PhRMA Release: 11/99


Susan K. Finston

Government Employer

Ms. Susan K. Finston worked at the State Department for thirteen years in the Office of Intellectual Property and Competition serving in Chicago, Washington DC, Tel Aviv, Manila and London,.

Private Sector Employer

Ms. Finston is currently Assistant Vice President for Intellectual Property and Middle-East/Afican Affairs at PhRMA.


Daniel L. Spiegel

Government Employer

Mr. Daniel L. Spiegel served as United States Permanent Representative to the United Nations from 1993 to 1996. In addition, Mr. Spiegel served as U.S. envoy to the World Health Organization, the World Intellectual Property Organization, the U.N. Conference on Trade and Development, the International Labor Organization, the International Telecommunications Union and the U.N. High Commission for Refugees. From 1978 to 1979, Mr. Spiegal was a member of the State Department's Policy Planning staff from 1978 to 1979. From 1977 to 1978, Mr. Spiegel served as special assistant to Secretary of State Cyrus R. Vance. Prior to joining the State Department, Mr. Spiegel served as foreign policy legislative assistant to the late Senator Hubert H. Humphrey from 1971 to 1976 Earlier in his career, Mr. Spiegel was legislative assistant to Senator Alan Cranston from 1969 to 1971.

Private Sector Employer

Mr. Spiegel is currently a partner at the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Spiegel was a registered lobbyist for American Home Products.

Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile.


Donald C. Alexander

Government Employer

Mr. Donald C. Alexander served as Commissioner of Internal Revenue from 1973 to 1977. After his tenure as Commissioner, Mr. Alexander served on the Commission on Federal Paperwork from 1975 to 1977. From 1983 to 1984, Mr. Alexander served on the Interior Department's Coal Leasing Commission. From 1993 to 1996, he was a Commissioner of the Martin Luther King Jr. Federal Holiday Commission; and from 1987 to 1989 as Chairman of the Internal Revenue Service Exempt Organizations Advisory Group.

Private Sector Employer

Mr. Alexander is currently a partner in the tax section of Akin, Gump, Strauss, Hauer & Feld, L.L.P. (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Alexander was a registered lobbyist for Johnson & Johnson.

Source:

Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile.


S. Bruce Wilson

Government Employer

Mr. S Bruce Wilson worked almost 17 years at USTR. His career at USTR included a posting as Assistant U.S. Trade Representative for Intellectual Property, Services and Investment (a position currently held by Joseph Papovich), and a posting as Assistant U.S. Trade Representative for Industry and Services. In this capacity, Mr. Wilson headed U.S. delegations on intellectual property at the Uruguay Round negotiations. Mr. Wilson was involved in the establishment of the USTR Mission in Geneva. After his career in USTR, Mr. Wilson worked for the Ways and Means Committeee of the U.S. House of Representatives from 1991 to 1998. Mr. Wilson first served as Staff Director to the Subcommittee on Trade; he then served as Democatic Trade Counsel.

Private Sector Employer

Bruce Wilson is currently a partner at the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Wilson was a registered lobbyist for American Home Products.

Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile.


Edward J. Allera

Government Employer

Mr. Edward J. Allera was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA) from 1974 to 1978.

Private Sector Employer

Mr. Allera is currently a partner at the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Allera was an official lobbyist for Johnson & Johnson.

Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile.


Frank J. Donatelli

Government Employer

Mr. Frank J. Donatelli served as head of the Afica Bureau of USAID in 1983. From March 1984 until May 1985, Mr. Donatelli was Deputy Assistant to the President for Public Liaison at the White House. During the fall of 1984, he served on White House Chief of Staff James Baker's team that negotiated the presidential debates. From March 1987 to January 1989, Mr. Donatelli served as Assistant to President Reagan for Political and Intergovernmental Affairs. Earlier in his career, Mr. Donatelli worked for Ronald Reagan's presidential campaign from 1979 to 1980.

Private Sector Employer

Mr. Donatelli is currently a partner at the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Donatelli was a registered lobbyist for PhRMA.

Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile.


Barney J. Skladany, Jr.

Government Employer

Mr. J. Skladany, Jr. worked at the Criminal Division of the U.S. Department of Justice from 1970 to 1971.

Private Sector Employer

Mr. Skladany is currently a partner at the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Mr. Skladany was a registered lobbyist for Johnson

& Johnson and Warner-Lambert.

Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile.


Thaddeus J. Burns

Government Employer

 Mr. Thaddeus Burns worked for the USTR Mission in Geneva as U.S. Intellectual Property Attaché. As Intellectual Property Attaché, Mr. Burns served as the principal legal advisor to the USTR-Geneva office and the U.S. Mission to the United Nations. Mr. Burns represented the United States before WIPO and the WTO in addition to participating in U.S. delegations to the United Nations Conference on Trade and Development (UNCTAD) and the World Health Organization (WHO). Prior to joining USTR, Mr. Burns was an Associate Solicitor at USPTO.

Private Sector Employer

Thaddeus Burns is currently counsel for the law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P. Mr. Burns works at the public law and policy section of Akin Gump in Brussels, Belgium. Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. Mr. Burns' specialty is international intellectual property law-especially on issues pertaining to TRIPS and WIPO.Previously, he was an associate at at the law firm of Jones, Day, Reavis & Washington, D.C.

 Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile).
 


Elizabeth A. Hyman

Government Employer

Ms. Elizabeth A. Hyman was an Assistant Counsel at USTR from June 1997 through May 1998. Prior to joining USTR, Ms. Hyman was Associate Counsel to Vice President Al Gore (November 1996 to May 1997), Chief of Staff of the Violence Against Women Office at the Department of Justice (May to November 1996), and a Special Assistant U.S. Attorney in the Eastern District of Virginia (November 1995 to May 1996). From September 1994 to November 1995, Ms. Hyman served as Special Assistant to Attorney General Janet Reno. Prior to her career in Washington, Ms. Hyman was an Assistant Attorney General and Press Officer for Massachusetts Attorney General Scott Harshbarger (June 1992 to June 1994).

Private Sector Employer

Ms. Hyman is currently an associate law firm of Akin, Gump, Strauss, Hauer & Feld, L.L.P. (Washington, D.C. office). Akin Gump's clients include American Home Products, Pfizer, PhRMA, and Warner-Lambert. In 1998, Ms. Hyman was a registered lobbyist for American Home Products.

 Source: Akin, Gump, Strauss, Hauer & Feld, L.L.P Attorney Profile).


Howard H. Baker, Jr.

Government Employer

Former Senator Howard H. Baker, Jr. (R-Tennessee) served in the U.S. Senate between 1967 to 1985. Mr. Baker served as Vice Chairman of the Senate Watergate Committee (1973), Senate Minority Leader (1977-1981), Senate Majority Leader (1981-1985), and Chief of Staff to the President (February 1987 to July 1988).

Private Sector Employer

Mr. Baker is currently the head of the Public Policy and Regulatory practice of Baker, Donelson, Bearman & Caldwell. Baker Donelson's clients include PhRMA and Schering Plough. In 1998, Mr. Baker was a registered lobbyist for Schering-Plough.

 Source: Baker Donelson.


J. Keith Kennedy

Government Employer

Mr. J. Keith Kennedy was Staff Director of the Committee on Appropriations for Senator Mark O. Hatfield (R-Oregon).

Private Sector Employer

Mr. Kennedy is currently a Senior Public Policy Advisor at Baker, Donelson, Bearman & Caldwell (Washington, D.C. office). In 1998, Mr. Kennedy was a registered lobbyist for PhRMA and Schering Plough.

 Source: Baker Donelson.


George C. Montgomery

Government Employer

Mr. George C. Montgomery served as U.S. Ambassador to Oman from 1985 to 1989. From 1981 to 1985, Mr. Montgomery was Counsel to Senate Majority Leader Sen. Howard H. Baker, Jr., and Legislative Staffer for Sen. Baker from 1975 to 1980.

Private Sector Employer

Mr. Montgomery is currently an attorney at Baker, Donelson, Bearman & Caldwell (Washington, D.C. office). In 1998, Mr. Montgomery was a registered lobbyist for Schering Plough.

 Source: Baker Donelson.


John C. Tuck

Government Employer

Mr. John C. Tuck served as Under Secretary for the Department of Energy from 1989 to 1992. Mr. Tuck served as Assistant to the President from 1986 to 1989. From 1981 to 1986, Mr. Tuck served the the executive and legislative branches in various capacities including positions as Deputy Assistant to the President for Legislative Affairs, Depute Assistant to the President and Executive Assistant to the Chief of Staff, and Special Assistant to the President for Legislative Affairs -U.S. Senate.

Private Sector Employer

Mr. Tuck is currently an attorney at Baker, Donelson, Bearman & Caldwell (Washington, D.C. office). In 1998, Mr. Tuck was a registered lobbyist for Schering Plough.

 Source:

Baker Donelson.


Peter Barton Hutt

Government Employer

Mr. Peter Barton Hutt served as Chief Counsel to the FDA from 1971 to 1975.

Private Sector Employer

Mr. Hutt is currently a partner at the law firm of Covington & Burling. In 1998, Mr. Hutt was a registered lobbyist for PhRMA and the Nonprescription Drug Manufacturers Association .

 Source: Covington & Burling


Bruce N. Kuhlik

Government Employer

Mr. Bruce N. Kuhlik served as Assistant to the Solicitor General in the U.S. Department of Justice from 1984 to 1986..

Private Sector Employer

Mr. Kuhlik is currently a partner at the law firm of Covington & Burling. In 1998, Mr. Kuhlick was a registered lobbyist for Merck, PhRMA and the Nonprescription Drug Manufacturers Association .

 Source: Covington & Burling


Jeanne S. Archibald

Government Employer

Ms. Jeanne S. Archibald served as the General Counsel of the United States Department of the Treasury. As General Counsel, Ms. Jeanne Archibald was chief legal officer of the the Department of Treasury and its ten subordinate bureaus. Prior to her tenure in the U.S. Treasury Department, Ms. Archibald served at USTR supervising Special 301 proceedings. Prior to her tenure at USTR, Ms. Archibald served on the staff of the House of Representative's Ways and Means Commitee.

Private Sector Employer

Ms. Archibald is currently a partner at the law firm of Hogan & Hartson L.L.P. In 1998, Ms. Archibald was a registered lobbyist for PhRMA.

 Source: Hogan & Hartson, L.L.P.


Stephan E. Lawton

Government Employer

Mr. Stephan E. Lawton served as Chief Counsel of the Subcommittee on Health and the Environment of the United States House of Representatives (1971-1979).

Private Sector Employer

Mr. Lawton is currently a partner at the law firm of Hogan & Hartson L.L.P. In 1998, Mr. Lawton was a registered lobbyist for Amgen & Genentech.

 Source:

Hogan & Hartson, L.L.P.


Robert P. Brady

Government Employer

Mr. Robert P. Brady served in many positions in the US FDA including Associate Chief Counsel for Biologics; Associate Chief Counsel for Foods; and Associate Chief Counsel for Enforcement (1975-1981). From 1981 to 1983, Mr. Brady was Executive Assistant to the Commissioner of the Food and Drug Administration.

Private Sector Employer

Mr. Brady is currently a partner at the law firm of Hogan & Hartson L.L.P. In 1998, Mr. Lawton was a registered lobbyist for Genentech.

 Source: Hogan & Hartson, L.L.P.


Michael R. Pollard

Government Employer

Mr. Michael R. Pollard served as attorney advisor for health policy and assistant director of the Bureau of Consumer Protection at the Federal Trade Commission.

Private Sector Employer

Mr. Pollard is currently a partner at the law firm of Michaels & Bonner, P.C. In 1998, Mr. Pollard was a registered lobbyist for Merck. Prior to joining Michaels & Bonner, Mr. Pollard directed policy development and planning for the Pharmaceutical Manufacturers Association

 Source: Michaels & Bonner, P.C.


Thomas D. Parry

Government Employer

Mr. Thomas D. Parry served as Chief of Staff and Chief Counsel to Senator Orrin G. Hatch (R-Utah) for seven years.

Private Sector Employer

Mr. Parry is currently Vice President and Secretary-Treasurer of Parry, Romani, and DeConcini, Inc.- a Washington, DC based lobbying firm. In 1998, Mr. Parry was a registered lobbyist for Abbott, American Home Products, Bristol- Myers Squibb, Glaxo-Wellcome, Hoechst Marion Roussel, Hoffman- LaRoche, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto, Pfizer, PhRMA, Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham.

 Source: Parry, Romani, and DeConcini, Inc.


Romano Romani

Government Employer

Dr. Romano Romani served as Legislative Director and Staff Director to Senator Vance Hartke (D-Indiana) and Dennis DeConcini (D-Arizona) for ten years.

Private Sector Employer

Dr. Romani is currently President of Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Dr. Romani was a registered lobbyist fro Abbott, American Home Products, Bristol-Myers Squibb, Glaxo-Wellcome, Hoechst Marion Roussel, Hoffman- LaRoche, ICN

Pharmaceuticals, Interneuron

Pharmaceuticals, Metagenics, Monsanto,

Pfizer, PhRMA, Pharmacia & Upjohn,

Schering-Plough, and SmithKline Beecham.

 Source: Parry, Romani, and DeConcini, Inc.


Dennis DeConcini

Government Employer

Former Senator Dennis DeConcini (D-Arizona) served in the U.S. Senate for ten years. In this capacity, DeConcini served on the

Senate Appropriations Committee, where he chaired the Subcommittee on Treasury, Postal Service, and General Government, and served on the Subcommittees on Defense, Energy and Water Development, and Foreign Operations. Senator DeConcini also served on the Senate Judiciary Committee and chaired the Subcommittee on Patents, Copyrights and Trademarks. He also served on the Subcommittees on Antitrust, Monopolies and Business Rights, the Constitution and the Courts. In addition, the Senator served on the Select Intelligence Committee and was Chairman of the Committee in 1993 and 1994. Senator DeConcini also chaired the Commission on Security and Cooperation in Europe (Helsinki

Commission).

Source: Parry, Romani, and DeConcini, Inc.

Private Sector Employer

Mr. DeConcini is currently a partner at Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Mr. DeConncini was a registered lobbyist for Abbott, American Home Products, Bristol-Myers Squibb, Glaxo-Wellcome, Hoechst Marion Roussel, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto, Pfizer, Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham.


Edward H. Baxter

Government Employer

Mr. Edward H. Baxter served as counsel to the Senate Judiciary Committee, including a three year tenure as Chief Counsel and Staff Director to the Subcommittee on Patent, Copyrights and Trademarks. Prior to his career on the Hill, Mr. Baxter was an attorney with the Department of Interior.

Private Sector Employer

Mr. Baxter is currently Vice President for Government Relations at Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Mr. Baxter was a registered lobbyist for Abbott, American Home Products, Bristol-Myers Squibb, Glaxo-Wellcome, Hoechst Marion Roussel, Hoffman- LaRoche, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto, Pfizer, PhRMA, Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham.

 Source: Parry, Romani, and DeConcini, Inc.


Jack W. Martin

Government Employer

Mr. Jack W. Martin served as Associate Commissioner for Public Affairs at the FDA. After his tenure as Associate Commissioner for Public Affairs, Mr. Martin served as Special Assistant to the Commissioner for Policy under Commissioners Frank Young and David Kessler.

Private Sector Employer

Mr. Martin is currently Vice President for Federal Relations at Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Mr. Martin was a registered lobbyist for Abbott, American Home Products, Bristol-Myers Squibb, Glaxo-Wellcome, Hoechst Marion Roussel, ICN Pharmaceuticals, Interneuron Pharmaceuticals, Metagenics, Monsanto, Pfizer, Pharmacia & Upjohn, Schering-Plough, and SmithKline Beecham.

 Source: Parry, Romani, and DeConcini, Inc.


Linda A. Skladany

Government Employer

In the first term of the Reagan Administration, Ms. Linda A. Skladany worked as a Special Assistant to the Secretary of Education and to the United States Attorney General. After her tenure as Special Assistant, Ms. Skladany joined the United States Department of Transportation as Director of the Executive Secretariat under then Secretary Elizabeth Dole. In 1985, she joined President Reagan's White House staff where she served as Special Assistant to the President and Deputy Director of the White House Office of Public Liaison. In 1988, Ms. Sladany she was appointed by Presidents Reagan and Bush, respectively, as Commissioner and Acting Chairman of the Occupational Safety and Health Review Commission (OSHA).

Private Sector Employer

Ms. Skladany is currently Vice President for Congressional Relations at Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Ms. Skladany was a registered lobbyist for Abbott, American Home Products, Bristol-

Myers Squibb, Glaxo-Wellcome, Hoechst

Marion Roussel, Hoffman- LaRoche,

Interneuron Pharmaceuticals, Metagenics,

Monsanto, Pfizer, Pharmacia & Upjohn,

Schering-Plough, and SmithKline Beecham.

 Source: Parry, Romani, and DeConcini, Inc.


Shannon S. Davis

Government Employer

Ms. Shannos S. Davis served as a legislative assistant during the 102nd and 103rd Congresses to Congressman Sam Johnson (R-Texas).

Private Sector Employer

Ms. Davis is currently Director, Congressional Affairs at Parry, Romani, and DeConcini, Inc.- a Washington, D.C. based lobbying firm. In 1998, Ms. Davis was a registered lobbyist for Abbott, American Home Products, Bristol-

Myers Squibb, Hoechst Marion Roussel,

Interneuron

Pharmaceuticals, Metagenics, Monsanto,

Pfizer, Pharmacia & Upjohn,

Schering-Plough, and SmithKline Beecham

 Source: Parry, Romani, and DeConcini, Inc.


Judith A. Butler

Government Employer

Ms. Judith Butler was former chief of staff to three Republican Members of Congress and served in the Reagan White House.

Private Sector Employer

Ms. Butler is currently a Principal at Podesta.com, a Washington, D.C. based lobbying firm. In 1998, Ms. Butler was a registered lobbyist for Genentech and Genzyme.

Source: Podesta.com


Elizabeth A. Inadomi

Government Employer

Ms. Elizabeth A. Inadomi was Staff Counsel to the U.S. Senate Committee on Commerce, Science and Transportation for Senator Ernest Hollings and Senator Jay Rockefeller and Counsel to the U.S. House Subcommittee on Space for the late Rep. George Brown and Rep. Ralph Hall.

Private Sector Employer

Ms. Inadomi is currently a Principal at Podesta.com, a Washington, D.C. based lobbying firm. In 1998, Ms. Inadomi was a registered lobbyist for Genentech and PhRMA.

Source:

Podesta.com


Claudia James

Government Employer

Ms. Claudia James was Senior Legislative Assistant to Congressman Peter Peyser and Judiciary Legislative Assistant to Congressman Chris Dodd.

Private Sector Employer

Ms. James is currently President of Podesta.com, a Washington, D.C. based lobbying firm. In 1998, Ms. James was a registered lobbyist for Genentech and PhRMA.

Source:

Podesta.com


Anthony T. Podesta

Government Employer

Mr. Anthony T. Podesta was counsel to Senator Edward M. Kennedy and Assistant U.S. Attorney for the District of Columbia

Private Sector Employer

Mr. Podesta is currently Chairman of of Podesta.com, a Washington, D.C. based lobbying firm. In 1998, Mr. Podesta was a registered lobbyist for Genentech, Genzyme and PhRMA.

Source:

Podesta.com


Lee Skillington

Government Employer

Mr. Lee Skillington was Senior Counsel at the U.S. Patent and Trademark Office in the Office of Legislative and International Affairs.

Private Sector Employer

Lee Skillington is currently a partner in the law firm of Powell, Goldstein, Frazer, & Murphy LLP where he works on intellectual property issues. Powell Golstein's clients include Genentech and PhRMA. An example of Mr. Skillington's work in the private sector is evidenced in a memo (obtained through a FOIA request to USPTO) dated February 2, 2000, where Mr. Skillington and his colleague Jeff Kushan (see below), advised Carlos A. Silva (PhRMA) on the technical aspects of the Brazilian Presidential decree (Decree 3,201) permitting compulsory licensing (For more detail on Brazilian industrial property law see: http://www.cptech.org/ip/health/c/brazil/). In the memo, Messrs. Skillington and Kushan made recommendations to USTR on the position the U.S. Government should take on Decree 3,201.

Source: Powell Goldstein Attorney Directory


Jeffrey Kushan

Government Employer

Mr. Jeffrey Kushan spent over ten years with the USPTO, including a two-year assignment with USTR in Geneva, Switzerland (1995-1997). While serving in the USTR-Geneva office, Mr. Kushan participated in WTO dispute settlement proceedings against India and Pakistan (involving patent term protection for pharmaceuticals).

Private Sector Employer

Jeffrey Kushan is currently a partner in the law firm of Powell, Goldstein, Frazer, & Murphy LLP where he works on intellectual property and TRIPS issues. Mr. Kushan represented Merck at the CPT/HAI/MSF Compulsory Licensing conference in Geneva (March 1999) at Thaddeus Burns' insistence (see above). Powell Golstein's clients include Genentech and PhRMA.

Source: Powell Goldstein Attorney Directory.


Barry B. Direnfeld

Government Employer

Mr. Barry B. Direnfeld served as Chief Legislative Counsel to Senator Howard M. Metzenbaum, and Chief Counsel and Staff Director of the Senate Judiciary Committee's Subcommittee on Antitrust, Monopolies, and Business Rights.

Private Sector Employer

Mr. Direnfeld is currently a partner in the law firm of Swidler Berlin Sherrif Friedman. In 1998, Mr. Direnfeld was a registered lobbyist for Transkaryotic Therapies.

Source: Swidler Berlin.


Lester S. Hyman

Government Employer

A protege of John F. Kennedy., Mr. Lester S. Hyman served in the U.S. Securities & Exchange Commission, After his tenure at the S.E.C., Mr. Hyman worked at the U.S. Department of Housing and Urban Development. After his tenure at HUD, Mr. Hyman served as Secretary of Commerce. After this appointment, Mr. Hyman served as Chairman of the Democratic Party of Massachusetts.

Private Sector Employer

Mr. Hyman is currently of Counsel at the law firm of Swidler Berlin Sherrif Friedman. Mr. Hyman is a founding partner of Swidler Berlin. In 1998, Mr. Hyman was a registered lobbyist for Schering-Plough and SmithKline Beecham.

Source: Swidler Berlin.


H.P. Goldfield

Government Employer

Mr. H.P. Goldfield served as Assistant Secretary of Commerce for Trade Development. Prior to his tenure in the Commerce Department, Mr. Goldfield served as Associate Counsel to the President (1982-83) and as Assistant Counsel-White House (1981-82).

Private Sector Employer

Mr. Goldfield is currently a partner at the law firm of Swidler Berlin Sherrif Friedman. In 1998, Mr. Goldfield was a registered lobbyist for SmithKline Beecham and Transkaryotic Therapies.

Source: Swidler Berlin.


Richard A. Popkin

Government Employer

Mr. Richard A. Popkin served as senior export control policy advisor to the Under Secretary of Commerce for International Trade, and as Deputy for Policy to the Assistant Secretary of Commerce for Trade Administration (1983-1987).

Private Sector Employer

Mr. Popkin is currently a partner at the law firm of Swidler Berlin Sherrif Friedman. In 1998, Mr. Popkin was a registered lobbyist for SmithKline Beecham.

Source: Swidler Berlin.


Gary D. Slaiman

Government Employer

Mr. Gary D. Slaiman served as Chief Counsel and Staff Director for the U.S. Senate Labor and Human Resources Subcommittee on Labor. Prior to his tenure on the Labor Subcommitee, Mr. Slaiman was Counsel to the Senate Judiciary Subcommittee on Antitrust.

Private Sector Employer

Mr. Slaiman is currently a partner at the law firm of Swidler Berlin Sherrif Friedman. In 1998, Mr. Goldfield was a registered lobbyist for Transkaryotic Therapies

Source: Swidler Berlin.


Corrections or suggestions to Thiru Balasubramaniam thiru@cptech.org.


 
 

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Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   18:37:18 ET  Reply   Trace   Private Reply  


#11. To: PSUSA2, christine (#9)

Pooooooooooooor bebe. Can't win on points so try to create a conflict where none exists. When called on your dishonesty I can always count on you to erect a Strawman or some other dishonest subterfuge. You are 100% predictable.

Third Party Law: For a conflict to exist between two people, groups, nations, etc., ... there must be a third party unknown to both instigating the conflict.

So, what you are trying to do is take your having once again been caught lying and engaging in disinformation tactics and trying to twist other people's words to divert from that by creating a conflict between Christine and I.

Ain't gonna happen loser.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   18:45:09 ET  (2 images) Reply   Trace   Private Reply  


#12. To: PSUSA2 (#8)

the revolving wheel of corruption which is the FDA.

I read just fine.

You say Revolving Wheel Of Corruption = FDA. The FDA is totally corrupt according to what YOU said. Therefore all decisions by that totally corrupt FDA are not just worthless, but intentionally harmful (because it's totally corrupt, right?) because it results in some people dying. Well, people die. The FDA is not there to prevent people from ever dying.

You are not going to get one past me. lol. You just not that good.

But I understand why you accuse them of total corruption. That's because everyone there would have to be In On It.

It is amusing watching you spin your wheels of diversion, personal attacks and attempts to avoid anything of substance

How many fallacies can we find in your little incoherency?

FDA is not there to prevent people from ever dying.

Red Herring

False Dilemma/Dichotomy/Black or White Fallacy

False Analogy

You are not going to get one past me. lol. You just not that good.

Red Herring

Argumentum Ad Hominem

But I understand why you accuse them of total corruption. That's because everyone there would have to be In On It.

Strawman Argument

False Dilemma/Dichotomy/Black or White Fallacy

Lies and Deception: How the FDA Does Not Protect Your Best Interests.

Did you know that many retired FDA officials go to work as special advisors to the pharmaceutical and food industries?

It's true. Federal agencies like the FDA—which were created to protect consumers—often behave like branch offices of companies like Monsanto, which they are supposed to regulate. And when the names and dossiers of the individuals who work with allies in Congress and the White House to oppose food safety measures are revealed, the picture becomes even more sinister.

The fact is, it has been widely reported that FDA (Federal Drug Administration), EPA (Environmental Protection Agency), and USDA (United States Department of Agriculture) officials are frequently rewarded with lucrative jobs at the companies they were regulating.

Conflict of interest

This insidious conflict of interest exhibited by the U.S. food and pharmaceutical industries has been going on for almost half a century. Mark Gold, founder of the Aspartame Toxicity Information Center in Concord, New Hampshire (mgold@holisticmed.com) provides an overview of the situation in his "Analysis of the influence of the Aspartame Industry on the Scientific Committee on Food." 1 

"In the United States, corruption of governmental and scientific committees by the food industry was disclosed in the late 1960s and early 1970s. In an article in the journal Science (1972), it was revealed that the National Academy of Sciences (NAS) Food Protection Committee was being funded by the food, chemical and packaging industries. The U.S. Food and Drug Administration was relying on the NAS Committee for 'independent' information. The Chairman of the NAS Subcommittee investigating monosodium glutamate (MSG) had recently taken part in research partially funded by the MSG manufacturer. Another member of the Subcommittee became a spokesperson for the MSG industry. (Science 1972) Other members of the Subcommittee had ties to the MSG industry.

Since that time numerous governmental committees have been corrupted by the placement of food industry-funded consultants on these committees." 23

The revolving door

A recent report by the Edmonds Institute lists names of the possible hundreds of men and women who move in and out of "revolving doors" as Federal regulators and directors, commissioners and scientists at the companies they are supposed to regulate.4 

Close relationships between regulators and those they regulate are always a cause of concern because the conflict of interest inevitably results in the quality of regulation and oversight of a technology being compromised … which inevitably results in the promotion of foods and drugs that are frequently unsafe.

The Edmonds Institute has been researching these relationships for some time. Here are some examples:

Margaret Miller … former chemical laboratory supervisor for Monsanto, … now Deputy Director of Human Food Safety and Consultative Services, New Animal Drug Evaluation Office, Center for Veterinary Medicine in the United States Food and Drug Administration (FDA).56 

Michael Taylor, former legal advisor to the United States Food and Drug Administration (FDA)'s Bureau of Medical Devices and Bureau of Foods, later executive assistant to the Commissioner of the FDA,…still later a partner at the law firm of King & Spaulding where he supervised a nine-lawyer group whose clients included Monsanto Agricultural Company, … still later Deputy Commissioner for Policy at the United States Food and Drug Administration, … and later with the law firm of King & Spaulding … now head of the Washington, D.C. office of Monsanto Corporation.56 

Margaret Miller, Michael Taylor, and Suzanne Sechen (an FDA "primary reviewer for all rbST and other dairy drug production applications") were the subjects of a U.S. General Accounting Office (GAO) investigation in 1994 for their role in the FDA's approval of Posilac, Monsanto Corporation's formulation of recombinant bovine growth hormone (rbST or rBGH). The GAO Office found "no conflicting financial interests with respect to the drug's approval" and only "one minor deviation from now superseded FDA regulations". (Quotations are from the 1994 GAO report).

The FDA and Monsanto: Strange bedfellows

Monsanto was required to submit a scientific report on rBGH to the FDA so the agency could determine the growth hormone's safety. Margaret Miller put the report together, and in 1989 shortly before she submitted the report, Miller left Monsanto to work for the FDA. Guess what her first job was? Strangely enough, to determine whether or not to approve the report she wrote for Monsanto! The bottom line is that Monsanto approved its own report. Miller was assisted by another former Monsanto researcher, Susan Sechen.

But in an article titled "Not Milk: The USDA, Monsanto, and the U.S. Dairy Industry" Ché Green, founder and director of The ARMEDIA Institute, a nonprofit research and advocacy organization focusing on farm animal issues in the United States, writes that, "The results of the study, in fact, were not made available to the public until 1998, when a group of Canadian scientists obtained the full documentation and completed an independent analysis of the results. Among other instances of neglect, the documents showed that the FDA had never even reviewed Monsanto's original studies (on which the approval for Posilac {rBGH} had been based), so in the end the point was moot whether or not the report had contained all of the original data." 7 

And as though the FDA didn't already exhibit enough audacity it handed Michael Taylor the responsibility to make the decision as to whether or not rBGH-derived milk should be labeled. (At the time, Michael Taylor, who had previously worked as a lawyer for Monsanto, was executive assistant to the Commissioner of the FDA.)

In 1994, Taylor ended up writing the rBGH labeling guidelines that prohibit the dairy industry from stating that their products either contain or are free from rBGH. Even worse, to keep rBGH-milk from being "stigmatized" in the marketplace, the FDA ruled that the labels of non-rBGH products must state that there is no difference between rBGH and the natural hormone.8 

According to journalist Jennifer Ferraro, "while working for Monsanto,Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labeling laws concerning rBGH dairy products. In other words, Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto's drug." 9

The current situation

Monsanto is suing Maine-based Oakhurst Dairy for labeling their milk "Our Farmers' Pledge: No Artificial Growth Hormones." According to Monsanto, Oakhurst Dairy does not have the right to let its customers know whether its milk contains genetically engineered hormones. What hogwash! Oakhurst says they've been labeling their products like this for four years, in response to consumer demand.

Although rBGH has been banned in every industrialized nation in the world except for the United States, Monsanto continues to claim that rBGH-derived milk is no different from the natural stuff, despite documentation that rBGH milk contains substantially higher levels of a potent cancer tumor promoter called IGF-1.

This poses a serious risk to the entire U.S. population, which is now exposed to high levels of IGF-1 in dairy products, since elevated blood levels of IGF-1 are among the leading known risk factors for breast cancer, and are also associated with other major cancers, particularly colon and prostate.10 

In 1994, Monsanto sued two dairies and threatened several thousand retailers for labeling or advertising milk and dairy products as "rBGH-free." Despite Monsanto's intimidation tactics, more than 10% of U.S. milk is currently labeled as "rBGH-free," while sales of organic milk and dairy products (which prohibit rBGH) are booming.

And just to add insult to injury, in recent months a Monsanto-funded front group, the Center for Consumer Freedom, has launched a smear campaign against organic dairies, including Organic Valley, claiming they are defrauding consumers. 11

How Monsanto's policies have become U.S. policy

Prior to being the Supreme Court Judge who put G.W. in office, Clarence Thomas was Monsanto's lawyer. The U.S. Secretary of Agriculture (Anne Veneman) was on the Board of Directors of Monsanto's Calgene Corporation. The Secretary of Defense (Donald Rumsfeld) was on the Board of Directors of Monsanto's Searle pharmaceuticals. The U.S. Secretary of Health, Tommy Thompson, received $50,000 in donations from Monsanto during his winning campaign for Wisconsin's governor. The two congressmen receiving the most donations from Monsanto during the last election were Larry Combest (Chairman of the House Agricultural Committee) and Attorney General John Ashcroft. (Source: Dairy Education Board)

What can you do?

  1. Contact your state representatives and let them know your views.
  2. Educate yourself about what is really in our food.

Three recommended books:

Eric Schlosser, "Fast Food Nation" New York: Harper Collins, 2002.

Marion Nestle, Food Politics: "How the Food Industry Influences Nutrition and Health." University of California Press, March 2002.

Marion Nestle, "Safe Food: Bacteria, Biotechnology, and Bioterrorism." University of California Press, March 2003.

  1. Eat only organically grown and produced food. Sadly and unfortunately, we cannot trust the FDA or USDA to ensure the safety of our food.

Related Articles

How Sweet It Isn't: The political battle over sugar

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   19:08:50 ET  Reply   Trace   Private Reply  


#13. To: PSUSA2 (#8)

But I understand why you accuse them of total corruption. That's because everyone there would have to be In On It.

Keene, NH - GOP Presidential candidate Ron Paul rebuked the relationship between the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry during a press conference, stating that "the FDA and the drug companies are in bed together."

In the video of this event, recorded by Fox News, Paul also points a finger at health insurance firms. "Whether it's Democrats or Republicans reforming the medical care system, these corporations run the show,' he explained.

Known in his home state of Texas as a congressman who speaks his mind, Paul didn't hesitate when asked whether eliminating the FDA would be a reasonable solution. "I think so," he replied, "because they've done more harm than good."

In addition, Paul expressed his belief that collusion between the FDA and the pharmaceutical industry is intended to drive out competition. "What does the FDA do when it comes to alternative or natural products?" he asked. "The FDA and the drug industry keep them off the market."

The claim that the FDA and the drug companies are too intimately tied together has been illustrated by the "revolving door" hiring policies that have existed for years. These practices allow employees from private pharmaceutical research and lobbying firms to join the FDA, the Environmental Protection Agency (EPA) and other regulatory agencies, and return to their private sector jobs when they leave their government positions.

This hiring environment creates a conflict of interest that been blamed for numerous FDA failures, including the case reported by MSNBC in which the arthritis drug Vioxx was linked to thousands of deaths and eventually recalled by drug maker Merck. In 2005, an investigation initiated by the New York Times and conducted by the Center for Science in the Public Interest revealed that 10 of the 32 FDA panel members who originally approved Vioxx were paid consultants for Merck and other industry giants.

During a 2008 hiring drive, in which the FDA added over 1300 new doctors and scientists to its ranks, senior manager and recruitment director Kimberly Holden admitted that this dangerous relationship is part of the way things work.

"We have had some people who left to go into industry and ended up wanting to come back," Holden told USA Today. "The revolving door swings this way every once in a while."

Even though the The Hill reports that Paul trails Mitt Romney by a substantial margin in the race for the Republican Presidential nomination, his continued criticism of big government and big business is still igniting debate across America about the problems with the current political and financial system. In the end, perhaps he can claim the increase in public awareness of these important issues as a victory in itself.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   19:21:38 ET  Reply   Trace   Private Reply  


#14. To: PSUSA2, christine, Tom007, wudidiz, Eric Stratton, Ferret, all (#8) (Edited)

So, then your twisting misinterpretation and misrepresentation of what I wrote was intentional then? Correct?

You can't have it both ways. Either you intentionally twisted and misrepresented what I said or you can't read too well.

So, would you like to reconsider?


WellnessResources.com News and Views


How the FDA, Big Pharma, and Doctors Cause Injury for Profit

Sunday, November 01, 2009

Byron Richards, CCN

In some ways the health care in America is the finest in the world.  In other ways it is a severe risk to health, even deadly.  The dark side of this issue involves medication profits at the expense of human health.  This questionable health care approach costs at least 200 billion dollars a year and involves the costs of the drugs themselves, the injuries they cause, and the appropriate law suits that follow.  The perpetrators of this fraud are the pharmaceutical companies acting in tandem with the FDA, doctors paid under the table by Big Pharma, and gullible doctors willing to write off-label prescriptions based on the hype they hear from doctors on the take and Big Pharma sales reps.

Creating a market demand for this fraud is a health care system that blindly pays for it.  This issue is causing millions of injuries a year and tens of thousands of deaths.  It makes the Ponzi scheme run by Bernie Madoff pale in comparison.  It is ruining the legitimate health care needs of a nation.  Any expansion of mandatory health care funding will only make it worse, since the current scheme is set to feed off patients who don’t pay full price (or often any price) for the medications they “need.”

The scandals involving inappropriate use of medications are so numerous they defy believability, with FDA management either tacitly allowing or actively helping the various drug companies.  The FDA has a long history of pretense dating back to its inception over 100 years ago.  It is part of the DNA of the FDA’s dysfunctional culture.  FDA managers act in a revolving door capacity with the various industries they are supposed to be regulating.  What FDA mangers actually do is more akin to the activities of a police-force bully.  They seek to knock out competition for their friends in Big Pharma, Big Biotech, and Big Food, while acting as the gatekeepers of profits for the chosen few – often in disregard of the health consequences. 

It was only a few years ago that the FDA didn’t even know what drugs it had approved to be on the market.  Far worse, the FDA is quite lax on requiring the mandatory follow-up safety testing for the drugs that have been approved.  On October 26, 2009 the Government Accountability Office1 released a report blasting the FDA on this issue.  The lack of FDA due diligence has resulted in a situation wherein doctors and patients do not have a clear picture of the actual risks of virtually any drug, including the blockbusters in common use (such as birth control pills).  Big Pharma would rather not do these studies because when they do they often show the drug is far more dangerous than previously thought – which typically causes a drop in sales.  Why would any drug company want to shoot itself in the foot? 

The negative data submitted to the FDA during the drug approval process is seldom ever published in any meaningful way or context.  Rather, Big Pharma ensures that mostly the positive studies submitted to the FDA find their way into the literature.  Again, this skews the public understanding of the drug.  FDA management has been known to coerce and threaten its scientists to suppress negative news about drugs, often over-ruling their scientists so that a dangerous drug can be put on the market.  Such FDA management coercion of its own scientific staff came into full public view when it was discovered how Avandia, a diabetes drug, could get on the market without any warning that it causes heart failure

A classic example of Big Pharma intentionally suppressing the negative studies so as to paint a false rosy picture of a medication’s benefits are the anti-depressants.  In fact, the entire theory of the use of antidepressants upon which FDA-approved drug dispensing is based has recently been called into question.  Yet, these near-useless drugs are top sellers to our children.  The FDA yawns when antidepressant use is strongly linked to heart disease.

The issue is complicated by the fact that the scientific literature was intended as a communication format between doctors, scientists, and other health professionals.  It was never intended to have defense mechanisms against large financial interests trying to game the system for profit.  The pharmaceutical industry ghostwrites many of the studies that promote the values of its drugs.  Doctors and scientists put their names on the studies for a fee.  Celebrity doctors are paid large amounts by Big Pharma to act as sales reps at “scientific” conferences.  Universities and researchers who might publish negative data know they will be blacklisted from Big Pharma research spending in the future.  Many doctors are on the Big Pharma payroll, taking what amounts to bribes, kickbacks, and other “gifts.”  All doctors are subjected to intense Big Pharma propaganda as a major part of their training in medical school. 

A drug company doesn’t even have to prove a drug fixes anything.  Drugs simply have to prove they can move numbers on paper (surrogate endpoints).  This lax standard of effectiveness causes individuals to go on drugs to change numbers, take more drugs due to the side effects of the ones they are taking, and before long they are on ten drugs that don’t fix anything – piling on cost to the health care system and taxpayers.

Once drugs are on the market, Big Pharma uses all manner of illegal marketing to create buzz and demand for their drugs in ways that have never been tested for safety (off-label use).  Some regulatory action has been taken in recent months against these crimes, although the damage is already done and the false markets have been created as doctors seem to have little ethical concern writing prescriptions for uses that have never been demonstrated as safe or effective.  And then the Big Pharma lobby goes to work trying to get laws passed to expand its market (even tagetting children).

Big Pharma builds the cost of the fines into the cost of the drugs, which are paid for in higher health care costs and taxes.  It is how Big Pharma does business.  The FDA is impotent in defending the public from harm.  It has been proven that all the newer drugs of the past decade are twice as likely to injure.  While the FDA manages to report on the problem, it fails to do anything effective about it (which is how they plea to get more funding from Congress to spend on their pet projects, not safety).

This shifts the burden of demonstrating proof of harm to lawyers representing individuals who have been harmed and independent, poorly funded researchers who must risk the wrath of their colleagues to shine a light lot on huge problems.  Such researchers are often operating without the original data submitted to the FDA.  It takes years to pin down a problem.  By then, the drug in question has already made its money (and caused its harm) or its patent is about to expire (meaning it is no longer a top priority for the drug company).  Even when researchers present their findings of rather alarming harm, the FDA management yawns, drags its feet several more years, and then waters down its findings on the obvious problems so as to limit legal liability for its friends.

The examples of the drugs involved in this fraudulent charade are numerous, and especially involve drugs known as blockbusters (the big sellers).  One of the most egregious examples is the atypical anti-psychotic medications – poisoning our children and elderly with unthinkable off-label use that is incredibly damaging to health.  The atypical anti-psychotics include Zyprexa (Eli Lilly), Seroquel (AstraZeneca), Risperdal (Johnson & Johnson), Geodon (Pfizer), and a handful of others.

Since Eli Lilly knew that Zyprexa caused diabetes and didn’t let patients know this, they have already settled numerous “failure to warn” lawsuits totaling 1.2 billion dollars.  This year they agreed to another 1.42 billion, $615 million to settle the Justice Department’s criminal investigation and approximately $800 million to settle the civil investigations brought by the states for Medicaid fraud.  “Specifically, the plea states that Lilly promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia, although Zyprexa is not approved for such uses,” the company said in a statement.  Eli Lilly agreed to a misdemeanor charge, which is apparently the new standard for what a drug company gets when it kills elderly Americans (previously it was nothing).  A May 2009 study published in the Archives of Internal Medicine shows that even a single dose of anti-psychotic medication to an elderly patient doubles the risk of a serious adverse event leading to hospitalization and/or death. 

Anti-psychotics have become popular for their off-label use as the “drug of obedience.”  If you want a zombie, give the person an atypical anti-psychotic.  They became incredibly popular in nursing homes, especially if a senior citizen arrived upset at the idea of being put in a nursing home.  Or to keep patients with dementia from stirring up trouble.  Likewise, children in orphanages are another popular target.  These are extremely expensive drugs paid for by Medicare and Medicaid (taxpayers).

On October 29, 2009 AstraZeneca reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits regarding Seroquel.  One of the investigations was over improper activity of physicians involved in Seroquel clinical trials, apparently hiding the results of a negative drug trial prior to FDA approval and the other was over off-label use resulting in many children and elderly taking Seroquel.

Pfizer has agreed to pay $2.3 billion to settle criminal and civil liability due to its illegal off-label promotion of Bextra (a painkiller already pulled from the market), Geodon (like Zyprexa, an atypical anti-psychotic that injures children), Zyvox (an antibiotic), and Lyrica (an epilepsy drug).  Pfizer will plead guilty to one felony count violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud.  Geodon has a smaller percentage of the 12-billion-dollar-a-year poisoning campaign of our children and elderly, pulling in around $750 million.  It was widely promoted in an off-label manner for ADHD and behavioral issues facing children - a market that has been fraudulently created and continues to rack up sales.

And this past week Risperdol went on trial for its off-label uses.  The opening day of testimony saw one of its salesman admit he promoted the drug for off-label uses and did so knowing what he was doing was illegal – expect another large settlement.

While these settlements seem large they are costs that are passed on to the health care system as part of the price of the drug.  Off-label financial penalties are nothing more than a marketing cost.  And once the market is created doctors keep prescribing the medications for off-label use, thereby sustaining sales far in excess of any penalty.

None of these financial penalties is as the result of FDA actions.  To the contrary, in the midst of major controversy the FDA was found encouraging the use of these drugs on children!  It is the lawsuits that are defending public safety because the FDA does not do its job. 

And then there are the independent studies that finally prove what the FDA likely knew over a decade ago.  This past week a study in the Journal of the American Medical Association2 showed that children taking atypical anti-psychotic medication gained on average 18 pounds in 12 weeks.  The shocking part of the study was not the massive weight gain – it was that it took over a decade for independent researchers to prove what the FDA and Big Pharma already knew.  Needless to say, these children are on a fast track to heart disease, as changes in their LDL cholesterol and triglycerides clearly indicated.

The anti-psychotic medications serve as an example of the disregard for human health on the part of Big Pharma, the FDA, doctors and psychiatrists on the take, and those standing ready with their off-label Rx pads.  Tens of billions in fraudulent profit has been made and continues to pile up.  There are numerous other blockbuster drugs with similar sordid tales.  This is how business is done.  It is fraud.  The FDA drags its feet and will continue to drag its feet, regardless of what studies are published.  The FDA management is part of the fraud.

In the short term the only way to stop this fraud is to prevent federal programs (Medicare and Medicaid) and insurance companies from paying for any off-label medication use.  Also in the near term, off-label prescribing laws need to be drastically changed to protect the public.  The use of all types of psychotropic medications on children needs to be drastically curtailed or outright banned.  Over the next five to ten years medications already on the market need to prove their safety and actually prove they fix something in a definable period of time.  If all a drug can do is change numbers it is, once again, nothing that taxpayers and insurance companies should have to pay for. 

If people want to use drugs to change numbers, suppress symptoms, and conduct an experiment on themselves – fine – let them do so at their own expense.  The problem with health care reform is that President Obama is in a big hurry to pass legislation with this system of fraud built in.  In fact, the entire system is positioned to benefit thanks to the financial support Big Pharma is lending the administration, as the administration tries to make insurance companies out to be the villain.  Unless fraud is tackled head on, including the White House truly cleaning up its own FDA, there is no chance for containing health care costs in the current system or in anything currently proposed by the House or Senate.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   19:31:41 ET  Reply   Trace   Private Reply  


#15. To: PSUSA2 (#8)

I read just fine.

Got Soma?


Antidepressant Controversy: Media Conflicts of Interest - New York Times

Thu, 25 Mar 2004

FDA's advisory warning about antidepressant drugs received wide press coverage nationally. But few in the national media mentioned conflicts of interest as the obstacle to disclosure of evidence showing these drugs' adverse effects. Among the few exceptions: The Washington Post (below) and The Herald (So. Carolina) http://www.heraldonline.com/local/story/3443345p-3060286c.html

The New York Times front page article provided an overview of the controversy and noted the economic stakes-namely, that antidepressants generate $12 billion in sales. See: Gardiner Harris, Regulators Want Antidepressants to List Warning, NYT, March 23, 2004, A-1 http://www.nytimes.com/2004/03/23/health/23DEPR.html?hp

Contrary to FDA's continued efforts to protect drug manufacturers by reassurances that no evidence has demonstrated a link between suicide and antidepressants, children and adolescents did commit suicide after being prescribed one of these drugs. In controlled clinical trials, children taking an antidepressant were at two-to-three-fold risk of suicidal acts. An analysis of that evidence led British drug regulators to ban the drugs for children under 18. The FDA has yet to issue clear and unambiguous warnings indicating that evidence shows a connection between the effects of antidepressant drugs and hazardous behavioral changes, including sudden violent uncontrolled outbursts that psychiatrists call "toxic behavior."

The evidence comes from both clinical trials--mostly concealed until uncovered during court procedures--and the evidence comes from the real world of clinical care. The concealed trial evidence corroborates the testimonies of families who testified before FDA's advisory committee on February 2. FDA's ambiguous warning suggests the possibility of suicidal thinking at start of treatment, but is couched with disclaimers indicating lack of evidence. This equivocation raises doubts about the validity of the warning.

In fact, FDA officials have known for over a decade that antidepressants were linked to mania, agitation, extreme physical and psychological restlessness (called akathisia), and violent and suicidal behavior (euphemistically called "emotional lability") in children and adults who tested the drugs, compared to those given a placebo. In truth, the public was deliberately misled to believe the drugs were "safe and effective."

Indeed, expert psychiatrists from prestigious academic institutions--including the National Institute of Mental Health--consistently assured the public through media infomercials and uncritical news reports, that antidepressants were "safe and effective," encouraging screening for undiagnosed depression so that treatment could begin early in children and adults.

A clear eyed column by Gene Metrick, senior writer and copy desk chief for the Rocky Mount Telegram (below) is an indication that Americans in the hinterland are watching the spectacle and see through the smokescreens.

By contrast, a follow-up article in the New York Times appears to be doing damage control. This article transmits false assertions of stakeholders in the drug industry. Those who have for years deluded the public, with unsubstantiated claims that antidepressant drugs were "safe and effective." The Times follow-up states:

"Studies in children taking the antidepressants have not found an increase in suicide. But studies of some drugs have suggested that they might increase the risk of suicidal thought and behaviors...There is no solid data linking use of the drugs to suicide in adults." Readers are led to think that "some drugs" but not antidepressants increase the risk of suicide. See: Overprescribing Prompted Warning on Antidepressants By Denise Grady and Gardiner Harris, NYT, March 24, 2004 P. A-13 http://www.nytimes.com/2004/03/24/health/24DEPR.html?pagewanted=print&position=

Such misleading statements bring into focus a major issue that compromises most medical news reports in the major American press/media. An issue that is never discussed or acknowledged is the media's own conflict of interests.

The pharmaceutical industry spent $3.2 billion in direct consumer advertising in 2003--an increase of 22.5% since 2002. Industry's lavish purchase of advertising space bought influence and good will. That influence has penetrated the editorial boards and science news departments of prestigious newspapers, including the New York Times, the major TV networks, as well as local news outlets, and supermarket pulp publications.

Industry's overpowering influence is reflected in what, and how, medical drug related issues are reported and distorted. The American media has become the purveyor of (mostly) upbeat reports about medical breakthroughs--that almost never actually materialize. The media also engages in promotions of screening for "disease of the month" campaigns that are in fact, marketing campaigns.

News reports, such as the follow-up report about the FDA advisory is an accommodation to its advertisers and to the stakeholders in the psychotropic drug industry. Not only does the Times reveal advertising bias, but it fails to vet their sources of information for conflicts of interest.

The Times quotes Dr. Harold Koplewicz, indicating only that he is the director of the NYU Child Study Center: "The fear I have about this warning is that many teenagers will not get the medicine because it will build resistance among their parents, and that is really a tragic outcome."

Dr. Koplewicz, not only is one of the staunchest promoters of psychotropic drugs for children, he was a co-investigator and co-author of a major Paxil study (329) in which he and the pillars of American child psychiatry claimed to have found that Paxil was "well tolerated and effective" for adolescents. The article has now been discredited by the FDA. Furthermore, an internal 1998 memo by the manufacturer of Paxil indicates that only the positive data from study 329 would be published, but the negative findings would not.

Readers trust the New York Times, believing that the experts selected by the Times for their views, are objective unless identified as having a financial interest in the product/ company or have taken a position. The Times failed to disclose any of the relevant background information that demonstrates a decidedly biased point of view. The Times article also failed to disclose the very substantial financial ties to the drug industry of either Dr. Koplewicz or the NYU Child Study Center.

If the NY Times with its vast resources and expertise is so easily misled by industry-sponsored market expansion campaigns which are led by doctors who serve the industry as paid consultants, whose claimed scientific findings have been shaped by industry's directives, what can we expect from family advocacy groups who also receive substantial financial support from the same industry?

Failure to disclose financial and professional conflicts of interest undermines the integrity of Times science / medicine news reports. One wonders whether the NY Times should revise its motto, from "All the News that's Fit to Print" to All the News that Increases Pharmaceutical Advertising?

See: Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial. Journal of the American Academy of Child & Adolescent Psychiatry, 2001, 40:762-772.

See: U.S. Food and Drug Administration (FDA) CDER. Memorandum from Thomas P. Laughren, MD, to Members of PDAC and Peds AC January 5, 2004. Online at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1.htm

See: GSK 1998 memo online at: http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

Contact: Vera Hassner Sharav
Tel: 212-595-8974

~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?language=printer
THE WASHINGTON POST
New Warning Urged On Antidepressants
Alert Would Address Suicidal Tendencies

By Shankar Vedantam
Washington Post Staff Writer

Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put new warning labels on popular antidepressant medications, including Paxil, Zoloft and Luvox, alerting doctors and consumers to watch for suicidal tendencies, hostility and agitation in patients taking the drugs.

The agency's action focuses on 10 antidepressant drugs in all and follows a warning by the British government last year advising physicians not to prescribe most widely used antidepressants to children. Last month, families of American adolescents who killed themselves while taking the medications implored the FDA to take comparable steps, and an expert advisory committee urged greater vigilance in the use of the medications in children with depression.

The agency said it does not know whether the medications -- which include several drugs known as selective serotonin reuptake inhibitors, or SSRIs -- are responsible for reported side effects such as inner restlessness, agitation and suicidal thoughts in some people. Officials said they are drawing greater attention to known cautionary information while a team of outside researchers completes a comprehensive analysis of the possible risks.

Patients taking the drugs who experience behavioral side effects should contact their physicians, said Russell Katz, director of neuropharmacological drug products at the FDA. If the symptoms are new or severe, he added, doctors should consider lowering the dose or stopping the drug.

Yesterday's move by the agency calls for warning-label changes for adults as well as children, and for patients who are depressed as well as those who use the drugs for unrelated problems.

"The advice applies across the board whether the drugs are used for any indication -- psychiatric or not," Katz said.

Critics of the medications called yesterday's move a victory and demanded that the FDA go further. Although Prozac is the only one of this class of drugs that has been specifically approved to treat depression in children, doctors are writing tens of thousands of prescriptions for many of the others, based on their clinical judgment that the drugs are safe and effective.

"Doctors are going to be on the line not to prescribe them as if they were pacifiers," said Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in children found that the medications did no better than dummy pills in treating depression, but that these studies have been hidden from doctors and the public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American psychiatric establishment, which has broadly supported the efficacy of the drugs, have been unduly influenced by the pharmaceutical industry. Dozens of lawsuits against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that discouraging patients from taking them could lead to greater numbers of suicides. They insist that suicidal tendencies or attempts among patients taking the drugs are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as antidepressant use has surged in recent years, said Thomas P. Laughren, FDA team leader for psychiatric drug products. While no one knows whether the two trends are linked, he said at a news conference yesterday, such data framed the context in which the FDA acted.

The drugs affected by yesterday's announcement are Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

C 2004 The Washington Post Company

http://www.rockymounttelegram.com/news/newsfd/auto/feed/news/
2004/03/24/1080176226.26609.0348.7142.html

Metrick: Is treatment worse than depression?
By Gene Metrick, Rocky Mount Telegram

It seems the pharmaceutical industry may have to add another side effect to the long list of warnings that accompanies the stable of antidepressant drugs it has been hawking for the past dozen years or so. The ads touting these drugs as the latest wonder cures for depression or anxiety appear repeatedly each day on television. The commercials always end with a standard disclaimer advising of the possible side effects of their use: nausea, dry mouth, sleeplessness, decreased libido, constipation, diarrhea, loss of appetite, etc.

Now the companies might just be warning that the use of an antidepressant may also increase the risk of suicide.

The U.S. Food and Drug Administration on Monday asked drug makers to include detailed warnings alerting doctors and consumers to watch for suicidal tendencies, agitation and hostility in patients using the drugs. The new warnings cover Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro and Luvox - known as seratonin reuptake inhibitors (SSRIs) - as well as Wellbutrin, Serzone and Remeron, which are a different class of drugs.

The FDA's move comes on the heels of an emotionally charged public hearing in February in which dozens of distraught family members testified that they blamed the drugs for the suicides or suicide attempts of their loved ones.

Unfortunately, it's uncertain what effect the FDA ruling will have on drug makers, who have not said whether they will comply with the agency's request. Vera Hassner Sharav, president of the New York-based patient advocacy group, the Alliance for Human Research, told me that she sees the ruling as "equivocating and ambiguous."

"It gives a warning but says, 'We don't have the evidence.' Now, if you don't have the evidence that the drugs are to blame, what's the point of putting the warnings on them?" she said. "The FDA has had this data in their files for years - either they didn't warn the public in order to shield the industry, or they're incompetent."

Dozens of lawsuits have been filed against drug makers by families of patients who committed or attempted suicide while taking antidepressants. For its part, the FDA says it is reviewing 25 clinical trials of the drugs on children and will release its findings this summer.

The British government last year banned the use of all such drugs except Prozac for the treatment of depression in children. But the problem is not confined to adolescent patients.

Independent studies have suggested a link between antidepressants and suicide since 1990, when Harvard researcher Dr. Martin Teicher reported that an internal Eli Lily study of adults showed "a greater incidence of suicide attempts in people in the study receiving Prozac than in people receiving placebo ..."

The big drug companies have labeled those kinds of studies as "proprietary" and have refused to release the findings of such reports. But they've been very forthcoming in releasing research results that show no links between antidepressants and an increased risk of suicide.

Remember, these antidepressant medications have become a giant cash cow for the pharmaceutical industry, with as many as 30 million Americans estimated to be taking one or another of them. Heck, you can even visit any number of online pharmacies for a free medical consultation with a doctor and have your prescription shipped to you right away.

Of course, as one of the service representatives for prescriptiondrugs.com told me Wednesday over the telephone, you do have to answer the doctor's questions "truthfully."

Depression is a very serious and debilitating disease. And antidepressants can play a vital role in helping people overcome it. But the rush to overprescribe these drugs for a vast array of ailments is quite disturbing, especially when the full range of risks that accompany them seem to still remain pretty much uncertain.

It's part of a syndrome that can be thought of as the "Drugging of America," a growing trend reminiscent of the "Brave New World" described by Aldous Huxley in his novel of the same name. The residents of Huxley's future world were freed from the anxieties, cares and conscience of their present-day counterparts through the use of the drug "Soma," which brought the phrase, "Don't worry, be happy" to a whole new level. Better living through chemistry, indeed.

Gene Metrick is a senior writer and copy desk chief for the Rocky Mount Telegram.

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   19:59:32 ET  (1 image) Reply   Trace   Private Reply  


#16. To: Original_Intent (#15)

I go out, cut grass, drink a beer, cool down, and what do I find? tl;dr

What it comes down to is you want to throw away the baby with the bath water.

Because there is abuse doesn't mean drugs are bad. It means some doctors are bad.

It can be as common as giving antibiotics for a common cold, to giving antidepressants for people that are a little down, to addictive sleeping pills when they aren't needed except to feed the addiction, to whatever abuse you care to name.

It's like saying that water is bad because people can drown, and it's the Swimming Pool Certification Administration that is corrupt and at fault.

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"Those who believe the Bible are those who know the least about it".

Thomas Paine (1737-1809), author and reformer

PSUSA2  posted on  2012-05-19   20:27:46 ET  Reply   Trace   Private Reply  


#17. To: PSUSA2 (#16) (Edited)

My point is that the corruption is systemic and deep. It colors every action of the agency - they are wholly owned by the industries they allegedly regulate. Toxic products and pharmaceuticals are left on the market or approved for one reason only - M-O-N-E-Y.

The FDA's own scientists recommended AGAINST the approval of Aspartame a.k.a. NutraSweet a.k.a. AminoSweet. So, of course it was approved. And you can run through the entire dirty history of the agency and find the same recurring themes over, and over, and over, and over again.

Throw in the FDA's war against natural and alternative treatments and therapies as well as their opposition to labeling food products as GMO or containing rGBH and the picture grows nastier. The reality is that the war is against anything not controlled by Big Pharma and what you have is the operations of a corrupt agency run amok.

And I did not say ALL pharmaceuticals are without benefit, but the process by which they are approved, by panels financially beholden to Big Pharma and the well documented revolving door, is corrupt and not just a little corrupt. Any benefit to the patient is purely secondary and almost coincidental.

And the USDA is just as bad. When a few small premium meat packers were going to install extra testing for Mad Cow over and beyond what was required the USDA threatened to shut them down if they did. So, they were going to put in an extra layer of safety and the USDA threatens to shut them down for trying to protect people's health? Now tell me who's interests were served by that? Why it couldn't be big meat packers now could it?

Perseverent Gardener
"“Believe nothing merely because you have been told it. Do not believe what your teacher tells you merely out of respect for the teacher. But whatsoever, after due examination and analysis, you find to be kind, conducive to the good, the benefit, the welfare of all beings - that doctrine believe and cling to, and take it as your guide.” ~ Gautama Siddhartha — The Buddha

Original_Intent  posted on  2012-05-19   20:48:27 ET  Reply   Trace   Private Reply  


#18. To: Original_Intent (#17) (Edited)

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"Those who believe the Bible are those who know the least about it".

Thomas Paine (1737-1809), author and reformer

PSUSA2  posted on  2012-05-20   6:43:02 ET  Reply   Trace   Private Reply  


#19. To: Original_Intent (#17)

When a few small premium meat packers were going to install extra testing for Mad Cow over and beyond what was required the USDA threatened to shut them down if they did. So, they were going to put in an extra layer of safety and the USDA threatens to shut them down for trying to protect people's health?

I missed that. Or I just dont remember it.

But the rest I agree with.

Throw in the FDA's war against natural and alternative treatments

That could also be a result of the old patent medicine scams of the past and present. Lots of people want money, not just the legit drug companies, and they don't care if people die. Just calling it a "natural and alternative treatment" doesn't mean it isn't a scam.

I remember a MSM story a while back where prozac (iirc) was detected in waste water. That's how doped up these sheep are. No one put a gun to their heads and forced those pills down their throats.

You seem to be forgetting the main enabler here. That is the average US citizen. Without the sheep bleating for drugs, because they want a quick and painless fix for everything, this probably wouldn't even be a problem.

------------------------------------------

"Those who believe the Bible are those who know the least about it".

Thomas Paine (1737-1809), author and reformer

PSUSA2  posted on  2012-05-20   6:44:16 ET  Reply   Trace   Private Reply  


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