Corruption Just Confessed by FDA Scientists

[Guest guest]

Corruption Just Confessed by FDA Scientists!

 

 

Group of FDA Scientists sent letter to

President-elect Barack Obama’s transition team

“pleading with him – managers have ordered,

intimidated and coerced scientists to manipulate

data in violation of the law”!!!!!!!

 

Comment from Martini: Easy way to clean up this

mess. Here’s when it

happened:

<http://www.mpwhi.com/the_new_fda.htm>http://www.mpwhi.com/the_new_fda.htm

Dr. Arthur Hull Hayes was responsible when he

over-ruled the Board of Inquiry that had revoked

the petition for approval of aspartame, the

deadly addictive excitoneurotoxic carcinogenic

drug that interacts with virtually all drugs and

vaccines due to damage to the mitochondria. Note

the article about the “new FDA”. We need to

bring back the “old FDA”. Ken Stoller,

M.D.,Pediatrician, would be willing to accept

the position of FDA Commissioner and clean up

this mess. From the aspartame documentary, Sweet

Misery: A Poisoned World,

<http://www.soundandfury.tv/>www.soundandfury.tv

here is James Turner, Atty, explaining how all

this was caused by Donald Rumsfeld:

<http://www.soundandfury.tv/pages/rumsfeld.html>http://www.soundandfury.tv/pages\

/rumsfeld.html

 

 

In this movie you will also see Arthur

Evangelista who worked for the FDA and left

because of this corruption back in the early

1990’s. At the time the FDA were already

manipulating data. Let’s send him back with Dr.

Stoller. He will get rid of aspartame which is

costing this country trillions in medical care

and stop the suffering of those with aspartame

cancer and all the diseases listed in the 1000

page medical text, “Aspartame Disease: An Ignored

Epidemic”,

<http://www.sunsentpress.com/>www.sunsentpress.com

by H. J. Roberts, M.D. Over 100, 000 people have

died just from drug interaction.

 

The FDA also serves above the law. The law

states a Citizens Petition must be answered in

180 days. My petition for ban was sent certified

mail over 6 years ago and remains

unanswered. The imminent health hazard amendment

which is required to be answered in a week or ten

days was sent over a year ago. The FDA simply

violates the law. FDA toxicologist, Dr. Adrian

Gross, told Congress in 1985 that aspartame

(NutraSweet/Equal, etc.) violated the Delaney

Amendment because it caused brain tumors and

brain cancer, and if the FDA violated its own law

who is left to protect the public? Read it on

the front page banner of

<http://www.mpwhi.com/>www.mpwhi.com Is somebody now listening?

 

Read on below my signature.

 

Dr. Betty Martini, D.Hum, Founder

Mission Possible International

9270 River Club Parkway

Duluth, Georgia 30097

770 242-2599

<http://www.mpwhi.com/>www.mpwhi.com,

www.dorway.com and <http://www.wnho.net/>www.wnho.net

Aspartame Toxicity Center, www.holisticmed.com/aspartame

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

<http://www.ahrp.org/>http://www.ahrp.org and

<http://ahrp.blogspot.com/>http://ahrp.blogspot.com

 

 

Underscoring a crisis of Confidence among FDA

senior scientists, the Wall Street Journal

reports (below) that a group of FDA scientists

sent a letter on Wednesday to President-elect

Barack Obama's transition team " pleading with him

to restructure the agency, saying managers have

ordered, intimidated and coerced scientists to

manipulate data in violation of the law. "

 

The nine scientists, whose names have been

provided to the transition team and to some

members of Congress, say the FDA is a

" fundamentally broken " agency and describe it as

place where honest employees committed to

integrity can't act without fear of reprisal.

 

" There is an atmosphere at FDA in which the

honest employee fears the dishonest employee, "

according to the letter, addressed to John

Podesta, head of Mr. Obama's transition team.

 

The letter will likely increase pressure on Tom Daschle, Mr. Obama's

choice to head the Department of Health and Human

Services, to make sweeping changes at the agency.

The scientists' main concerns are with FDA's

scientific review process for medical devices,

which they characterize as having been " corrupted

and distorted by current FDA managers, thereby

placing the American people at risk. "

 

Adding insult to injury, another report in the WSJ (below) describes

how FDA's $1.5 million PR contract with the Center for Professional

Development, Inc (CPD)is being spent to promote

FDA's Deputy Commissioner, Janet Woodcock,

PhRMA's choice for Commissioner, as a " visionary leader. "

 

In essence, CPD is providing promotional services to create an

illusion of excellence about the FDA and its top

brass--much as it does for its pharmaceutical

company clients. The strategy is to divert

attention from serious safety issues that cause

preventable deaths with promotional puff pieces,

such as an " inspirational " FDA slide presentation. See:

<http://s.wsj.net/public/resources/images/OB->http://s.wsj.net/public/resources/\

images/OB-

 

CX588_fda_sl_D_20090107193024.jpg

 

 

The slide presentation is in the same genre as Merck's notorious

power point slide presentation to its Vioxx sales

staff, captioned " The Payoff " in which " Bonus, "

appeared on a slide, showing a sales

representative holding a glowing bag of money.

 

The fact that Deputy Commissioner, Janet

Woodcock, MD, is a serious contender for the FDA

Commissioner slot is an indication that the Obama

team has, until now been unaware of the agency's

failing grades on detecting and averting drug safety catastrophes.

 

Dr. Woodcock, as some of you may recall, has been a major player

siding with drug industry interests when these

clash with consumer safety issues. Indeed, Dr.

Woodcock staunchly defended the agency's decision

to keep Vioxx on the market even as Merck

withdrew the drug. On Nov. 14, 2004, she stated:

" There was more bleeding with naproxen, and more cardiovascular

events with Vioxx. If you look at the numbers,

it's a wash. " She said the FDA and its outside

experts decided the balance of gastrointestinal

benefit and heart risk justified keeping the drug on the market. [1]

<http://www.iol.co.za/index.php>http://www.iol.co.za/index.php?

sf=31 & set_id=1 & click_id=31 & art_id=qw110053998

0868B243

 

Evidence of a cover-up was documented in a

November 1, 2004 article in the Wall Street

Journal, citing internal company e-mails and

marketing materials. [2] On November 5 2004, an

article posted on the Internet site of the

British medical journal, The Lancet reported that

by 2000, scientific evidence existed of an

increased risk of heart attacks and strokes due to use of Vioxx.

 

" The record indicates that the actions of both

Merck and the US Food and Drug Administration

(FDA) contributed to the nearly 30,000 excess

cases of heart attacks and sudden cardiac deaths

that resulted from the use of the drug between

1999 and 2003. While Merck sought to cover up the

danger of its own drug to protect its bottom

line, the US government aided the company by

approving sale of the drug without conducting any serious investigation into

potential harmful consequences of its use. "

 

Dr. Woodcock is among the agency's powerful

administrative officers who tried to silence

safety scientists--including David Graham,

MD--who brought to light the lethal hazards of drugs such as Vioxx.

 

On November 18, 2004, Dr. David Graham, a senior

FDA safety expert testified before the Senate

Finance Committee, providing estimated excess

deaths due to VIOXX and called the VIOXX case

" a profound regulatory failure. " Dr. Graham said

flatly that the FDA was " 'incapable of

protecting America' from another dangerous drug "

and cited five additional potentially dangerous

drugs on the market: " the acne drug Accutane, the weight loss drug Meridia,

the anti-cholesterol drug Crestor, the pain reliever Bextra, and the

asthma drug Serevent. " And he was proven right on all counts!

 

References:

1. Michael Johnsen. FDA official defends agency,

warns drug pipeline could slow Drug Store News, Feb 14, 2005.

2. Mathews AW and Martinez B. E-mails suggest

Merck knew Vioxx's dangers at early stage. Wall

Street Journal; November 1, 2004; available at

<http://www.wsj.com/>http://www.wsj.com.

 

Contact: Vera Hassner Sharav

veracare

212-595-8974

 

<http://online.wsj.com/article/SB123142562104564381.html>http://online.wsj.com/a\

rticle/SB123142562104564381.html

THE WALL STREET JOURNAL

FDA Scientists Ask Obama to Restructure Drug Agency

By ALICIA MUNDY and JARED A. FAVOLE

 

WASHINGTON -- A group of scientists at the U.S. Food and Drug

Administration on Wednesday sent a letter to

President-elect Barack Obama's transition team

pleading with him to restructure the agency, saying managers have

ordered, intimidated and coerced scientists to

manipulate data in violation of the law.

 

The nine scientists, whose names have been

provided to the transition team and to some

members of Congress, say the FDA is a

" fundamentally broken " agency and describe it as

place where honest employees committed to

integrity can't act without fear of reprisal.

 

" There is an atmosphere at FDA in which the

honest employee fears the dishonest employee, "

according to the letter, addressed to John

Podesta, head of Mr. Obama's transition team.

 

The letter will likely increase pressure on Tom Daschle, Mr. Obama's

choice to head the Department of Health and Human

Services, to make sweeping changes at the agency.

 

The scientists' main concerns are with the agency's scientific review

process for medical devices, which they characterize as having been

" corrupted and distorted by current FDA managers,

thereby placing the American people at risk. "

 

They sent a similar letter in October to the

powerful House Energy and Commerce Committee, but

the latest one provides more detailed

allegations about problems at the agency, such as

the threat of disciplinary action against

scientists who dissent from management.

 

The FDA has been working " very closely " with Mr.

Obama's transition team and will address any

issues or concerns the team presents, said agency

spokeswoman Judy Leon. She said the agency is

" actively engaged in a process to explore the

staff members' concerns and take appropriate action. "

 

The group says they have taken their concerns to the head of the FDA,

Commissioner Andrew von Eschenbach, and his

assistant commissioner for accountability and

integrity, attorney Bill McConagha. The scientists say no

one has been held accountable, and say some of the problematic

managers have been promoted and rewarded.

 

The Energy and Commerce Committee's Democratic

and Republican leaders sent a letter to von

Eschenbach in November, saying it had " received

compelling evidence of serious wrongdoing " at the

agency. The members wrote that they were told

McConagha had found the FDA doctors' evidence

compelling, and that their findings supported

removal of certain managers in the device division.

 

The agency has been under fire from both parties in both Houses of

Congress as being too close to industry. Several leading politicians,

including Sen. Chuck Grassley have complained

that FDA leaders often ignore or suppress their

own scientists' opinions on safety issues involving drugs and devices.

 

Those concerns were also aired in a report by the

National Academy of Sciences' Institute of

Medicine in 2006. FDA leaders, including drug

division chief Janet Woodcock, have said they are

working to improve the culture at the FDA, and

are listening to dissent from their experts and doctors.

 

In addition to Mr. Daschle, the letter was sent to the doctor leading

the transition team's assessment of problems at the FDA, Joshua

Sharfstein, and to nine members of Congress

including Sen. Edward Kennedy who chairs the Health Committee.

 

Members of the transition team weren't available to discuss the

letter or whether they intend to address it publicly.

 

The scientists appear to hope that their concerns will pressure Mr.

Daschle to quickly change leadership at the FDA.

Von Eschenbach has said he is planning to step

down on Jan. 20, the date of Mr. Obama's inauguration.

 

Indeed, the group said Mr. Daschle has recognized in his book, Critical:

What We Can Do About the Health-Care Crisis, that

the 1998 approval of some mammography

computer-aided detection devices is an example of

the breakdown of the independent scientific review process at the FDA.

 

The group says the FDA approved such devices

without clinical evidence showing they were

effective in detecting breast cancer. Since 2006,

FDA physicians and scientists have recommended

five times that these devices not be approved

without valid scientific and clinical evidence.

 

The group said there needs to be a complete restructuring of the

evaluation and approval process, and that Mr.

Obama needs to sign new legislation giving

protection to government employees who speak out against corruption.

 

Write to Alicia Mundy at alicia.mundy and

Jared A. Favole at jared.favole

~~~~~~~~

 

<http://online.wsj.com/article/SB123137470811862863.html>http://online.wsj.com/a\

rticle/SB123137470811862863.html?

 

mod=igoogle_wsj_gadg

v1 & #

THE WALL STREET JOURNAL

JANUARY 8, 2009

FDA Outlays for Morale-Boosting Draw Fire From Lawmakers

By ALICIA MUNDY

 

At a recent retreat for Food and Drug Administration employees, a

slide show likened the agency's top drug

regulator, Janet Woodcock, to " visionary leaders "

such as Golda Meir and Gandhi. See the slide presentation. FDA slide

<http://s.wsj.net/public/resources/images/OB->http://s.wsj.net/public/resources/\

images/OB-

 

CX588_fda_sl_D_20090107193024.jpg

 

 

Some lawmakers are fuming about a $1.5 million contract for morale-

boosting

that the FDA awarded the consultant that prepared

the slideshow. The agency's problems, including

questions about decisions on the safety of some

popular medicines, are likely to come up in

Senate confirmation hearings starting Thursday on

Tom Daschle's nomination to be secretary of Health and Human Services.

 

[Picture: Janet Woodcock shown testifying before

Congress last May.] Her agency has drawn

criticism for hiring a consultant to help boost morale.

 

The slide show was presented at a management

conference last month for nearly 500 employees of

the FDA's drug division, organized by the Center

for Professional Development Inc., an Oakland,

Calif., consulting firm. The meeting was part of

a contract the division awarded to the consultant

in late 2007 to " improve workplace leadership " and " empower staff " following a

critical report by the Institute of Medicine, part of the National

Academy of Sciences. The report faulted the

division for sometimes ignoring FDA scientists'

concerns about drug safety, including their

complaints that the division tilts toward industry in decision-making.

 

Rep. John Shimkus (R., Ill.) called the contract and the conference a

waste. " To remove managers for two days to

discuss this morale problem, instead ofputting

food and drug safety first, is ridiculous, " he said.

 

FDA officials defended the contract and the conference as appropriate

responses to the IOM's 2006 report. John Jenkins, one of Dr. Woodcock's

deputies at the Center for Drug Evaluation and Research, said the slide

listing his boss alongside Margaret Thatcher, Steve Jobs and other

" visionary leaders " was presented partly to inject humor into the

proceedings. But Dr. Jenkins also said that " many people view " Dr.

Woodcock

" as being a visionary leader " in the context of her job. In a recent

interview, Dr. Woodcock said she set up the current system for

doctors to report possible side effects of drugs.

She also says she has pushed efforts to give scientists a greater voice.

 

Republicans on the House Energy and Commerce

Committee have opened an inquiry into the

consultant contract, saying they are angry at

how the FDA is spending money when it has cited

a staff shortage in delaying decisions on new drugs.

 

Rep. Joe Barton, a Texas Republican, said of the slide presentation:

" It's a cinch that if I spent a nickel of taxpayers' money to rank myself

with [sam] Houston and [stephen F.] Austin, I'd

have some explaining to do after the laughter died down. "

 

Dr. Woodcock's critics say her division is at the center of problems

cited by the IOM's report. It has been the focus

of a series of drug-safety related crises in the

past several years, prompting about a

dozen hearings or investigations in the House

and Senate. The division has come under fire for

letting drugs such as the painkiller Vioxx and

diabetes drug Avandia remain on the market after

safety concerns were raised. Vioxx was pulled in

2004, while Avandia remains available with a strong warning about heart risk.

 

Mr. Shimkus complained that the agency shouldn't have given the

contract to a firm that " lists numerous

pharmaceutical companies as clients -- at a

time when those same ties are being questioned

within FDA. " Ten major pharmaceutical companies

are among the Center for

Professional Development's current and former

clients, including GlaxoSmithKline PLC,

Bristol-Myers Squibb Co., Pfizer Inc., Merck & Co. and Novartis AG.

 

An official biography of the center's president, Charlotte Milliner,

says she " worked with one of the leading

pharmaceutical companies to build a partnership

with the Food and Drug Administration that will

allow them to bring drugs to market faster while maintaining safety. "

 

Ms. Milliner said her experience with many drug makers is an asset

for the FDA. " I think any time that people have a

sense of the environment in which people work, it's an advantage, " she said.

 

Dr. Jenkins said there is no problem with hiring a consultant who also

advises companies regulated by the FDA. " I think it's quite silly to

bring that up as a point, " he said.

 

Write to Alicia Mundy at alicia.mundy

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

<http://www.ahrp.org>http://www.ahrp.org and

<http://ahrp.blogspot.com>http://ahrp.blogspot.com

 

FYI

 

Underscoring a crisis of Confidence among FDA senior scientists, the Wall

Street Journal reports (below) that a group of

FDA scientists sent a letteron Wednesday to

President-elect Barack Obama's transition team

" pleading with him to restructure the agency,

saying managers have ordered, intimidated and

coerced scientists to manipulate data in violation of the

law. "

 

The nine scientists, whose names have been

provided to the transition team and to some

members of Congress, say the FDA is a

" fundamentally broken " agency and describe it as

place where honest employees committed to

integrity can't act without fear of reprisal.

 

" There is an atmosphere at FDA in which the

honest employee fears the dishonest employee, "

according to the letter, addressed to John

Podesta, head of Mr. Obama's transition team.

 

The letter will likely increase pressure on Tom

Daschle, Mr. Obama's choice to head the

Department of Health and Human Services, to make

sweeping changes at the agency. The scientists'

main concerns are with FDA's scientific review

process for medical devices, which they

characterize as having been " corrupted and

distorted by current FDA managers, thereby

placing the American people at risk. "

 

Adding insult to injury, another report in the

WSJ (below) describes how FDA 's $1.5 million PR

contract with the Center for Professional

Development, Inc (CPD)is being spent to promote

FDA's Deputy Commissioner, Janet Woodcock,

PhRMA's choice for Commissioner, as a " visionary leader. "

 

In essence, CPD is providing promotional services

to create an illusion of excellence about the FDA

and its top brass--much as it does for its

pharmaceutical company clients. The strategy is

to divert attention from serious safety issues

that cause preventable deaths with promotional

puff pieces, such as an " inspirational " FDA slide presentation. See:

<http://s.wsj.net/public/resources/images/OB-CX588_fda_sl_D_20090107193024.jp>ht\

tp://s.wsj.net/public/resources/images/OB-CX588_fda_sl_D_20090107193024.jpg

 

The slide presentation is in the same genre as

Merck's notorious power point slide presentation

to its Vioxx sales staff, captioned " The Payoff "

in which " Bonus, " appeared on a slide, showing a

sales representative holding a glowing bag of money.

 

The fact that Deputy Commissioner, Janet

Woodcock, MD, is a serious contender for the FDA

Commissioner slot is an indication that the Obama

team has, until now been unaware of the agency's

failing grades on detecting and averting drug safety catastrophes.

 

Dr. Woodcock, as some of you may recall, has been a major player siding with

drug industry interests when these clash with consumer safety issues.

Indeed, Dr. Woodcock staunchly defended the agency's decision to keep Vioxx

on the market even as Merck withdrew the drug. On Nov. 14, 2004, she stated:

" There was more bleeding with naproxen, and more cardiovascular events with

Vioxx. If you look at the numbers, it's a wash. " She said the FDA and its

outside experts decided the balance of gastrointestinal benefit and heart

risk justified keeping the drug on the market. [1]

<http://www.iol.co.za/index.php?sf=31 & set_id=1 & click_id=31 & art_id=qw110053998>ht\

tp://www.iol.co.za/index.php?sf=31 & set_id=1 & click_id=31 & art_id=qw110053998

0868B243

 

Evidence of a cover-up was documented in a November 1, 2004 article in the

Wall Street Journal, citing internal company e-mails and marketing

materials. [2] On November 5 2004, an article posted on the Internet site of

the British medical journal, The Lancet reported that by 2000, scientific

evidence existed of an increased risk of heart attacks and strokes due to

use of Vioxx.

 

" The record indicates that the actions of both Merck and the US Food and

Drug Administration (FDA) contributed to the nearly 30,000 excess cases of

heart attacks and sudden cardiac deaths that resulted from the use of the

drug between 1999 and 2003. While Merck sought to

cover up the danger of its own drug to protect

its bottom line, the US government aided the

company by approving sale of the drug without

conducting any serious investigation into

potential harmful consequences of its use. "

 

Dr. Woodcock is among the agency's powerful

administrative officers who tried to silence

safety scientists--including David Graham,

MD--who brought to light the lethal hazards of drugs such as Vioxx.

 

On November 18, 2004, Dr. David Graham, a senior

FDA safety expert testified before the Senate

Finance Committee, providing estimated excess

deaths due to VIOXX and called the VIOXX case

" a profound regulatory failure. " Dr. Graham said

flatly that the FDA was " 'incapable of protecting

America' from another dangerous drug " and cited

five additional potentially dangerous drugs on

the market: " the acne drug Accutane, the weight

loss drug Meridia, the anti-cholesterol drug

Crestor, the pain reliever Bextra, and the asthma

drug Serevent. " And he was proven right on all counts!

 

 

References:

1. Michael Johnsen. FDA official defends agency, warns drug pipeline could

slow Drug Store News, Feb 14, 2005.

2. Mathews AW and Martinez B. E-mails suggest Merck knew Vioxx's dangers at

early stage. Wall Street Journal; November 1, 2004; available at

<http://www.wsj.com>http://www.wsj.com.

 

Contact: Vera Hassner Sharav

<veracareveracare

212-595-8974

 

 

http://online.wsj.com/article/SB123142562104564381.html

THE WALL STREET JOURNAL

FDA Scientists Ask Obama to Restructure Drug Agency

By ALICIA MUNDY and JARED A. FAVOLE

 

WASHINGTON -- A group of scientists at the U.S.

Food and Drug Administration on Wednesday sent a

letter to President-elect Barack Obama's

transition team pleading with him to restructure

the agency, saying managers have ordered,

intimidated and coerced scientists to manipulate data in violation of the law.

 

The nine scientists, whose names have been

provided to the transition team and to some

members of Congress, say the FDA is a

" fundamentally broken " agency and describe it as

place where honest employees committed to

integrity can't act without fear of reprisal.

 

" There is an atmosphere at FDA in which the

honest employee fears the dishonest employee, "

according to the letter, addressed to John

Podesta, head of Mr. Obama's transition team.

 

The letter will likely increase pressure on Tom

Daschle, Mr. Obama's choice to head the

Department of Health and Human Services, to make

sweeping changes at the agency.

 

The scientists' main concerns are with the agency's scientific review

process for medical devices, which they characterize as having been

" corrupted and distorted by current FDA managers,

thereby placing the American people at risk. "

 

They sent a similar letter in October to the

powerful House Energy and Commerce Committee, but

the latest one provides more detailed allegations

about problems at the agency, such as the threat

of disciplinary action against scientists who dissent from management.

 

The FDA has been working " very closely " with Mr.

Obama's transition team and will address any

issues or concerns the team presents, said agency

spokeswoman Judy Leon. She said the agency is

" actively engaged in a process to explore the

staff members' concerns and take appropriate action. "

 

The group says they have taken their concerns to

the head of the FDA, Commissioner Andrew von

Eschenbach, and his assistant commissioner for

accountability and integrity, attorney Bill

McConagha. The scientists say no one has been

held accountable, and say some of the problematic

managers have been promoted and rewarded.

 

The Energy and Commerce Committee's Democratic

and Republican leaders sent a letter to von

Eschenbach in November, saying it had " received

compelling evidence of serious wrongdoing " at the

agency. The members wrote that they were told

McConagha had found the FDA doctors' evidence

compelling, and that their findings supported

removal of certain managers in the device division.

 

The agency has been under fire from both parties

in both Houses of Congress as being too close to

industry. Several leading politicians, including

Sen. Chuck Grassley have complained that FDA

leaders often ignore or suppress their own

scientists' opinions on safety issues involving drugs and devices.

 

Those concerns were also aired in a report by the

National Academy of Sciences' Institute of

Medicine in 2006. FDA leaders, including drug

division chief Janet Woodcock, have said they are

working to improve the culture at the FDA, and

are listening to dissent from their experts and doctors.

 

In addition to Mr. Daschle, the letter was sent

to the doctor leading the transition team's

assessment of problems at the FDA, Joshua

Sharfstein, and to nine members of Congress

including Sen. Edward Kennedy who chairs the Health Committee.

 

Members of the transition team weren't available

to discuss the letter or whether they intend to address it publicly.

 

The scientists appear to hope that their concerns

will pressure Mr. Daschle to quickly change

leadership at the FDA. Von Eschenbach has said he

is planning to step down on Jan. 20, the date of Mr. Obama's inauguration.

 

Indeed, the group said Mr. Daschle has recognized

in his book, Critical: What We Can Do About the

Health-Care Crisis, that the 1998 approval of

some mammography computer-aided detection devices

is an example of the breakdown of the independent

scientific review process at the FDA.

 

The group says the FDA approved such devices

without clinical evidence showing they were

effective in detecting breast cancer. Since 2006,

FDA physicians and scientists have recommended

five times that these devices not be approved

without valid scientific and clinical evidence.

 

The group said there needs to be a complete

restructuring of the evaluation and approval

process, and that Mr. Obama needs to sign new

legislation giving protection to government

employees who speak out against corruption.

 

Write to Alicia Mundy at

<alicia.mundyalicia.mundy

and Jared A. Favole at

<jared.favolejared.favole

~~~~~~~~

 

http://online.wsj.com/article/SB123137470811862863.html?mod=igoogle_wsj_gadg

v1 & #

THE WALL STREET JOURNAL

JANUARY 8, 2009

FDA Outlays for Morale-Boosting Draw Fire From Lawmakers

By ALICIA MUNDY

 

At a recent retreat for Food and Drug

Administration employees, a slide show likened

the agency's top drug regulator, Janet Woodcock,

to " visionary leaders " such as Golda Meir and

Gandhi. See the slide presentation. FDA slide

<http://s.wsj.net/public/resources/images/OB-CX588_fda_sl_D_20090107193024.jp>ht\

tp://s.wsj.net/public/resources/images/OB-CX588_fda_sl_D_20090107193024.jpg

 

Some lawmakers are fuming about a $1.5 million

contract for morale-boosting that the FDA awarded

the consultant that prepared the slideshow. The

agency's problems, including questions about

decisions on the safety of some popular

medicines, are likely to come up in Senate

confirmation hearings starting Thursday on Tom

Daschle's nomination to be secretary of Health and Human Services.

 

[Picture: Janet Woodcock shown testifying before

Congress last May.] Her agency has drawn

criticism for hiring a consultant to help boost morale.

 

The slide show was presented at a management

conference last month for nearly 500 employees of

the FDA's drug division, organized by the Center

for Professional Development Inc., an Oakland,

Calif., consulting firm. The meeting was part of

a contract the division awarded to the consultant

in late 2007 to " improve workplace leadership " and " empower staff " following a

critical report by the Institute of Medicine,

part of the National Academy of Sciences. The

report faulted the division for sometimes

ignoring FDA scientists' concerns about drug

safety, including their complaints that the

division tilts toward industry in decision-making.

 

Rep. John Shimkus (R., Ill.) called the contract

and the conference a waste. " To remove managers

for two days to discuss this morale problem,

instead of putting food and drug safety first, is ridiculous, " he said.

 

FDA officials defended the contract and the

conference as appropriate responses to the IOM's

2006 report. John Jenkins, one of Dr. Woodcock's

deputies at the Center for Drug Evaluation and

Research, said the slide listing his boss

alongside Margaret Thatcher, Steve Jobs and other

" visionary leaders " was presented partly to

inject humor into the proceedings. But Dr.

Jenkins also said that " many people view " Dr.

Woodcock " as being a visionary leader " in the

context of her job. In a recent interview, Dr.

Woodcock said she set up the current system for

doctors to report possible side effects of drugs.

She also says she has pushed efforts to give scientists a greater voice.

 

Republicans on the House Energy and Commerce

Committee have opened an inquiry into the

consultant contract, saying they are angry at how

the FDA is spending money when it has cited a

staff shortage in delaying decisions on new drugs.

 

Rep. Joe Barton, a Texas Republican, said of the

slide presentation: " It's a cinch that if I spent

a nickel of taxpayers' money to rank myself with

[sam] Houston and [stephen F.] Austin, I'd have

some explaining to do after the laughter died down. "

 

Dr. Woodcock's critics say her division is at the

center of problems cited by the IOM's report. It

has been the focus of a series of drug-safety

related crises in the past several years,

prompting about a dozen hearings or

investigations in the House and Senate. The

division has come under fire for letting drugs

such as the painkiller Vioxx and diabetes drug

Avandia remain on the market after safety

concerns were raised. Vioxx was pulled in 2004,

while Avandia remains available with a strong warning about heart risk.

 

Mr. Shimkus complained that the agency shouldn't

have given the contract to a firm that " lists

numerous pharmaceutical companies as clients --

at a time when those same ties are being

questioned within FDA. " Ten major pharmaceutical

companies are among the Center for Professional

Development's current and former clients,

including GlaxoSmithKline PLC, Bristol-Myers

Squibb Co., Pfizer Inc., Merck & Co. and Novartis AG.

 

An official biography of the center's president, Charlotte Milliner, says

she " worked with one of the leading

pharmaceutical companies to build a partnership

with the Food and Drug Administration that will

allow them to bring drugs to market faster while maintaining safety. "

 

Ms. Milliner said her experience with many drug

makers is an asset for the FDA. " I think any time

that people have a sense of the environment in

which people work, it's an advantage, " she said.

 

Dr. Jenkins said there is no problem with hiring a consultant who also

advises companies regulated by the FDA. " I think

it's quite silly to bring that up as a point, " he said.

 

Write to Alicia Mundy at <alicia.mundyalicia.mundy