TIME inquiry finds top officials at vital gov agencies lack credentials for the

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[sSRI-Research] TIME inquiry finds top officials at vital gov

agencies lack credentials for the job

 

 

 

 

TIME inquiry finds top officials at vital gov agencies lack

credentials for the job

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

The New York Times reports today that the mystery of Lester Crawford's

abrupt resignation as head of the FDA " fueled speculation that he had

investments in companies regulated by the FDA. " The Times reports

that Crawford's brother in law confirmed that Crawford " quit over

financial disclosure form. " We also learn that his wife's family had a

large pharmaceutical distribution company, Walker Drug Co, which was

sold for $140 million and that his wife, Catherine Walker Crawford

shared in the proceeds of that deal, but she said her family ties had

nothing to do with his resignation. The Times reports: " Mr. Walker,

meanwhile, said he had no question that his sister and her husband

would weather the controversy over his resignation.

 

" It's a tough, sad situation. But they'll make it because they're very

strong Christians. " [1]

 

How timely for TIME magazine to report about cronyism in Washington.

Many important positions at vital government agencies that are

supposed to protect our health and our safety--foremost among these

the Food and Drug Administration--are filled by cronies a la " Mike

Brown, " who got their positions through political and /or corporate

connections rather than professional expertise.

 

TIME reports about the serious concerns raised both at the agency and

Congress about Scott Gottlieb, MD, a young doctor whose the lack of

expertise in matters of drug safety evaluation does not justify his

being appointed to the # 2 position at the FDA. Those concerns are

magnified by Gottlieb's prior ties to the drug industry, which he

acknowledges were " quite extensive " -nine companies including Eli

Lilly, Roche and Proctor & Gamble--and his lack of expertise in drug

safety evaluation.

 

Although he insists his role at the agency is shaping broad policies

such as communication between the FDA, doctors and patients, TIME

reports that internal e-mail messages reveal that " scientists'

drug-safety decisions at the FDA are being second-guessed by a

33-year-old doctor turned stock picker. "

 

Gottlieb is described as a " noted authority " who had written more than

300 policy and medical articles. However, TIME reports, " many of those

articles criticized the FDA for being too slow to approve new drugs

and too quick to issue warning letters when it suspects ones already

on the market might be unsafe. "

 

Gottlieb's official biography, TIME reports, omits mention of his most

recent job as editor of the Forbes/Gottlieb Medical Technology

Investor, in which he offered such tips as " Three Biotech Stocks to

Buy Now. " Although he denies he would ever be involved in determining

whether an individual drug should be on the market, the evidence (in

the form of a series of e-mails to FDA staff) shows the opposite to be

true: Time reports: " Behind the scenes Gottlieb has shown an

interest in precisely those kinds TIME article in which Gottlieb

attempted to interfere with scientists' safety verdict to help

manufacturers:

 

" One instance took place on September 15, when the FDA decided to stop

the trial of a drug for multiple sclerosis during which three people

had developed an unusual disorder in which their bodies eliminated

their blood platelets and one died of intracerebral bleeding as a

result. In an e-mail obtained by TIME, Gottlieb speculated that the

complication might have been the result of the disease and not the

drug. " Just seems like an overreaction to place a clinical hold " on

the trial, he wrote. The FDA scientists disagreed.

 

In another instance involving FDA's rejection of Pfizer's osteoporosis

drug, Gottlieb is shown to have attempted to intervene after the FDA

rejected Pfizer's drug.

 

Given that drugs whose safety is in doubt pose life-threatening risks

for the public, one must wonder what conflicting interest might prompt

a young doctor employed as a public servant, to use his influence at

the FDA by raising doubts about the judgment of senior, expert drug

safety officers who determined that a drug was unsafe for use? Has

this doctor ever intervened on the side of greater safety?

An editorial in the Wall Street Journal defends both Scott Gottlieb

and Andrew von Eschenbach, the Presiden's nominee to replace Lester

Crawford as Acting FDA Commissioner.

 

1. See: F.D.A. Chief Quit Over Financial Disclosure Form, His Wife's

Brother Says By STEPHANIE SAUL and ROBERT PEAR

THE NEW YORK TIMES, September 28, 2005 p. A-18

http://www.nytimes.com/2005/09/28/politics/28fda.html?pagewanted==print

Lester M. Crawford's wife has told family members that an

unintentional failure to disclose financial holdings prompted his

sudden resignation as commissioner of food and drugs last week, her

brother said yesterday. The former commissioner's wife, Catherine

Walker Crawford, discussed the resignation with her brother, William

W. Walker III of Birmingham, Ala., over the weekend, Mr. Walker said

in a telephone interview. Mr. Walker said Mrs. Crawford had told him

that " if they had to do it over again, they'd put everything in a

blind trust. "

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.cnn.com/2005/POLITICS/09/26/mike.brown.tm/

TIME: How many more Mike Browns are out there?

By MARK THOMPSON, KAREN TUMULTY, MIKE ALLEN / WASHINGTON

Tuesday, September 27, 2005; Posted: 12:49 p.m. EDT (16:49 GMT)

 

A TIME inquiry finds that at top positions in some vital government

agencies, the Bush Administration is putting connections before

experience.

 

In presidential politics, the victor always gets the spoils, and chief

among them is the vast warren of offices that make up the federal

bureaucracy. Historically, the U.S. public has never paid much

attention to the people the President chooses to sit behind those

thousands of desks. A benign cronyism is more or less presumed, with

old friends and big donors getting comfortable positions and

impressive titles, and with few real consequences for the nation.

 

But then came Michael Brown. When President Bush's former point man on

disasters was discovered to have more expertise about the rules of

Arabian horse competition than about the management of a catastrophe,

it was a reminder that the competence of government officials who are

not household names can have a life or death impact. The Brown

debacle has raised pointed questions about whether political

connections, not qualifications, have helped an unusually high number

of Bush appointees land vitally important jobs in the Federal Government.

 

The Bush Administration didn't invent cronyism; John F. Kennedy turned

the Justice Department over to his brother, while Bill Clinton gave

his most ambitious domestic policy initiative to his wife. Jimmy

Carter made his old friend Bert Lance his budget director, only to see

him hauled in front of the Senate to answer questions on his past

banking practices in Georgia, and George H.W. Bush deposited so many

friends at the Commerce Department that the agency was known

internally as " Bush Gardens. "

 

A plan from day one

The difference is that this Bush Administration had a plan from day

one for remaking the bureaucracy, and has done so with greater

success. As far back as the Florida recount, soon-to-be Vice President

Dick Cheney was poring over organizational charts of the government

with an eye toward stocking it with people sympathetic to the incoming

Administration.

 

Clay Johnson III, Bush's former Yale roommate and the Administration's

chief architect of personnel, recalls preparing for the inner circle's

first trip from Austin, Texas, to Washington: " We were standing there

getting ready to get on a plane, looking at each other like: Can you

believe what we're getting ready to do? "

 

The Office of Personnel Management's Plum Book, published at the start

of each presidential Administration, shows that there are more than

3,000 positions a President can fill without consideration for civil

service rules.

 

And Bush has gone further than most Presidents to put political

stalwarts in some of the most important government jobs you've never

heard of, and to give them genuine power over the bureaucracy. " These

folks are really good at using the instruments of government to

promote the President's political agenda, " says Paul Light, a

professor of public service at New York University and a well-known

expert on the machinery of government. " And I think that takes you

well into the gray zone where few Presidents have dared to go in the

past. It's the coordination and centralization that's important here. "

 

The White House makes no apologies for organizing government in a way

that makes it easier to carry out Bush's agenda. Johnson says the

centralization is " very intentional, and it starts with the people you

pick ... They're there to implement the President's priorities. "

Johnson asserts that appointees are chosen on merit, with political

credentials used only as a tie breaker between qualified people.

" Everybody knows somebody, " he says. " Were they appointed because they

knew somebody? No. What we focused on is: Does the government work,

and can it be caused to work better and more responsibly? ... We want

the programs to work. "

 

But across the government, some experienced civil servants say they

are being shut out of the decision making at their agencies. " It

depresses people, right down to the level of a clerk-typist, " says Leo

Bosner, head of the Federal Emergency Management Agency's (FEMA's)

largest union. " The senior to mid-level managers have really been

pushed into a corner career-wise. "

 

Concerns in the agencies themselves

Some of the appointments are raising serious concerns in the agencies

themselves and on Capitol Hill about the competence and independence

of agencies that the country relies on to keep us safe, healthy and

secure. Internal e-mail messages obtained by TIME show that

scientists' drug-safety decisions at the Food and Drug Administration

(FDA) are being second-guessed by a 33-year-old doctor turned stock

picker.

 

At the Office of Management and Budget, an ex-lobbyist with minimal

purchasing experience oversaw $300 billion in spending, until his

arrest last week. At the Department of Homeland Security, an agency

the Administration initially resisted, a well-connected White House

aide with minimal experience is poised to take over what many consider

the single most crucial post in ensuring that terrorists do not enter

the country again.

 

And who is acting as watchdog at every federal agency? A corps of

inspectors general who may be increasingly chosen more for their

political credentials than their investigative ones. Nowhere in the

federal bureaucracy is it more important to insulate government

experts from the influences of politics and special interests than at

the Food and Drug Administration, the agency charged with assuring the

safety of everything from new vaccines and dietary supplements to

animal feed and hair dye.

 

Scott Gottlieb at FDA

That is why many within the department, as well as in the broader

scientific community, were startled when, in July, Scott Gottlieb was

named deputy commissioner for medical and scientific affairs, one of

three deputies in the agency's second-ranked post at FDA.

 

His official FDA biography notes that Gottlieb, 33, who got his

medical degree at Mount Sinai School of Medicine, did a previous stint

providing policy advice at the agency, as well as at the Centers for

Medicare and Medicaid Services, and was a fellow at the American

Enterprise Institute, a conservative think tank.

 

What the bio omits is that his most recent job was as editor of a

popular Wall Street newsletter, the Forbes/Gottlieb Medical Technology

Investor, in which he offered such tips as " Three Biotech Stocks to

Buy Now. " In declaring Gottlieb a " noted authority " who had written

more than 300 policy and medical articles, the biography neglects the

fact that many of those articles criticized the FDA for being too slow

to approve new drugs and too quick to issue warning letters when it

suspects ones already on the market might be unsafe.

 

FDA Commissioner Lester Crawford, who resigned suddenly and without

explanation last Friday, wrote in response to e-mailed questions that

Gottlieb is " talented and smart, and I am delighted to have been able

to recruit him back to the agency to help me fulfill our public-health

goals. "

 

But others, including Jimmy Carter-era FDA Commissioner Donald

Kennedy, a former Stanford University president and now executive

editor-in-chief of the journal Science, say Gottlieb breaks the mold

of appointees at that level who are generally career FDA scientists or

experts well known in their field. " The appointment comes out of

nowhere. I've never seen anything like that, " says Kennedy.

 

Financial ties to the drug industry

Gottlieb's financial ties to the drug industry were at one time quite

extensive. Upon taking his new job, he recused himself for up to a

year from any deliberations involving nine companies that are

regulated by the FDA and " where a reasonable person would question my

impartiality in the matter. "

 

Among them are Eli Lilly, Roche and Proctor & Gamble, according to his

August 5 " Disqualification Statement Regarding Former Clients, " a copy

of which was obtained by TIME. Gottlieb, though, insists that his role

at the agency is limited to shaping broad policies, such as improving

communication between the FDA, doctors and patients, and developing a

strategy for dealing with pandemics of such diseases as flu, West Nile

virus and SARS.

 

Would he ever be involved in determining whether an individual drug

should be on the market? " Of course not, " Gottlieb told TIME. " Not

only wouldn't I be involved in that ... But I would not be in a

situation where I would be adjudicating the scientific or medical

expertise of the [FDA] on a review matter. That's not my role. It's

not my expertise. We defer to the career staff to make scientific and

medical decisions. "

 

Behind the scenes, however, Gottlieb has shown an interest in

precisely those kinds of deliberations. One instance took place on

September 15, when the FDA decided to stop the trial of a drug for

multiple sclerosis during which three people had developed an unusual

disorder in which their bodies eliminated their blood platelets and

one died of intracerebral bleeding as a result.

 

In an e-mail obtained by TIME, Gottlieb speculated that the

complication might have been the result of the disease and not the

drug. " Just seems like an overreaction to place a clinical hold " on

the trial, he wrote.

 

An FDA scientist rejected his analysis and replied that the

complication " seems very clearly a drug-related event. "

 

Osteoporosis drug rejected

Two days prior, when word broke that the FDA had sent a

" non-approvable " letter to Pfizer Inc., formally rejecting its Oporia

drug for osteoporosis, senior officials at the FDA's Center for Drug

Evaluation and Research received copies of an e-mail from Gottlieb

expressing his surprise that what he thought would be a routine

approval had been turned down. Gottlieb asked for an explanation.

 

Gottlieb defends his e-mails, which were circulated widely at the FDA.

" Part of my job is to ask questions both so I understand how the

agency works, and how it reaches its decisions, " he told TIME.

However, a scientist at the agency said they " really confirmed

people's worst fears that he was only going to be happy if we were

acting in a way that would make the pharmaceutical industry happy. "

 

The Oporia decision gave Pfizer plenty of reason to be unhappy: the

drug had been expected to produce $1 billion a year in sales for the

company.

 

Pfizer's stock fell 1.4% the day the rejection was announced. The FDA

has not revealed why it rejected the drug, and Pfizer has said it is

" considering various courses of action " that might resuscitate its

application for approval.

 

Health experts note that Gottlieb's appointment comes at a time of

increased tension between the agency and drug companies, which are

concerned that new drugs will have a more difficult time making it

onto the market in the wake of the type of safety problems that

persuaded Merck to pull its best-selling painkiller Vioxx from the

market last year.

 

The agency's independence has also come under question, most recently

with its decision last month to prevent the emergency contraceptive

known as Plan B from being sold over the counter, after an FDA

advisory panel recommended it could be. That Gottlieb sits at the

second tier of the agency, critics say, sends anything but a

reassuring signal.

 

David Safavian, U.S. procurement czar

David Safavian didn't have much hands-on experience in government

contracting when the Bush Administration tapped him in 2003 to be its

chief procurement officer. A law-school internship helping the

Pentagon buy helicopters was about the extent of it. Yet as

administrator of the Office of Federal Procurement Policy, Safavian,

38, was placed in charge of the $300 billion the government spends

each year on everything from paper clips to nuclear submarines, as

well as the $62 billion already earmarked for Hurricane Katrina

recovery efforts.

 

It was his job to ensure that the government got the most for its

money and that competition for federal contracts -- among companies as

well as between government workers and private contractors--was fair.

It was his job until he resigned on September 16 and was subsequently

arrested and charged with lying and obstructing a criminal

investigation into Republican lobbyist Jack Abramoff's dealings with

the Federal Government.

 

Safavian spent the bulk of his pregovernment career as a lobbyist, and

his nomination to a top oversight position stunned the tightly knit

federal procurement community. A dozen procurement experts

interviewed by TIME said he was the most unqualified person to hold

the job since its creation in 1974. Most of those who held the post

before Safavian were well-versed in the arcane world of federal contracts.

 

" It's one of the most powerful positions in terms of impacting what

the government does, and the kind of job -- like FEMA director -- that

needs to be filled by a professional. " ..xxx cut xxx

 

See complete article at:

http://www.cnn.com/2005/POLITICS/09/26/mike.brown.tm/

 

With reporting by Massimo Calabresi

2005 Time Inc.

 

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