The New Republic articl re: FDA & Drug Companies

March 21, 2002

http://www.thenewrepublic.com/doc.mhtml?i=express & s=culhane031802

Favor of the Month

Did the White House give the drug industry veto power over

FDA appointments?

by Christiane Culhane

Only at TNR Online | Post date 03.18.02 E-mail this

article

Perhaps because there's been so much coverage of campaign

finance reform to distract reporters, some important--and

disturbing--stories of apparent special influence have

managed to escape the media's normally harsh glare.

One such story is the tale of Alastair Wood, who was the

leading candidate to take over the Food and Drug

Administration (FDA) until the White House pulled his name

from contention last month.

Few agencies have a mandate to regulate such a broad swath

of American life as the FDA, which oversees products that

amount to one quarter of the nation's consumer economy and

80 percent of the nation's food supply. And few agencies

find themselves routinely mired in such high-profile

controversies. In the last few years, the FDA and its

officials have been major players in the debates over

tobacco, food safety, and the rules governing the

pharmaceutical industry.

It was Wood's expertise on the topic of drugs that made him

a promising candidate to run the FDA. A pharmacologist and

assistant vice chancellor at the Vanderbilt University

School of Medicine, Wood has spent his " entire professional

life studying and writing about drugs, " as he said in

recent

congressional testimony. He is the Drug Therapy editor for

perhaps the most prestigious medical publication in the

country, the New England Journal of Medicine, and he has

served on several FDA advisory committees.

Well-regarded by his peers, Wood has said he's particularly

interested in the way our increased understanding of the

human genome will lead to new drug discoveries, which in

turn will necessitate " paradigm shifts in the way we think

about evaluation of safety and efficacy. " When the Bush

administration let it be known that they were considering

Wood as their top candidate to head up the FDA, the choice

was hailed even by some of the administration's harshest

critics. As one such person, Public Citizen's Sidney Wolfe,

told me recently, Wood " should be the ideal candidate. "

Unfortunately, when it comes to health care issues, anybody

who makes folks like Sid Wolfe happy is bound to make

certain entrenched interests unhappy. That was certainly

true in Wood's case. And, unfortunately for him, the

special interest he antagonized was the pharmaceutical

industry.

For example, Wood has advocated for switching several

prescription drugs to over-the-counter status--a move that

would cost drug companies millions. (Pharmaceutical

companies can charge more for prescription drugs since

insurance companies are paying for them, shielding

consumers from the direct costs.) Wood says he is in favor

of extensive post-market surveillance of pharmaceuticals in

order to reassess safety and efficacy on an ongoing

basis. Wood notes (rightly) that monitoring drugs even

after initial approval can only help the pharmaceutical

industry in the long run, by preventing would-be disasters

(which might hurt the industry far more than a few recalls)

and giving the FDA more data on which to base its initial

assessments. " The greater our confidence in the ability to

generate quality post-marketing data, " Wood says, " the

greater our ability to approve drugs earlier. "

The idea that an FDA commissioner might from time to time

take positions at odds with the pharmaceutical industry

shouldn't be a liability; it ought to be an asset, given

the agency's role. But this particular administration has

reasons to think differently. In the 2000 election, the

pharmaceutical industry gave W. Bush $472,333, more

than four times the amount they gave to Al Gore, according

to the Center for Responsive Politics. During the

same election cycle, 96 percent of the soft money donations

from PhRMA (the Pharmaceutical Researchers and

Manufacturers of America) went to the Republicans. (Don't

forget, too, that Mitch s was an executive at Eli

Lilly, the pharmaceutical manufacturer, before he became

Bush's budget

director.)

When I called PhRMA, they insisted they had no position on

Wood's nomination. But the industry has made no secret

about their opposition to his ideas. And even if PhRMA

never said a word to anybody in the administration, those

donations alone would have been enough to make the White

House think twice before nominating somebody whom the

industry seemed

to find so objectionable. Indeed, when the White House

called Wood in late February to inform him that he was no

longer under consideration for the post, FDA watchers in

the public interest community and on Capitol Hill took

it for granted that Bush pulled back on the Wood nomination

because drug makers had a problem with it. As Jim Manley,

spokesperson for Senator Kennedy's office, said, " the

reality is that this is a pro-business Republican

administration that is very favorable to industry. " The

White House, naturally, insists it is merely looking for

the most qualified candidate. But given Wood's sterling

credentials, it's hard to imagine drug industry sentiments

didn't have something to do with it.

The problem for the White House is that this still leaves

them short one FDA commissioner nominee. And if the

administration now turns around and appoints somebody more

friendly to the pharmaceutical industry, it's bound

to raise the ire of Senate Democrats, who control the

nomination process and are already steamed about what

happened to Wood. So far, the administration has decided to

deal with this problem by not dealing with it at all. Bush

has simply appointed a deputy director--who doesn't need

Senate confirmation--and asked him to serve as acting

commissioner if, er, when the White House gets around to

appointing somebody permanently.

That appointee is Lester Crawford. A former inspections

administrator in the Department of Agriculture who's now

director of the town University Center for Food and

Nutrition, his expertise is food safety--a topic of much

greater relevance these days thanks to concerns about

bioterrorism. But Crawford is a veterinarian by training,

marking the first time in 20 years that the person running

the FDA does not have an " M.D. " after his name. Does

that make him less qualified to run the agency? A few

liberal critics think so. Then again, when pleasing the

pharmaceutical industry is a criteria for choosing FDA

officials, it's hard to be choosy.

Christiane Culhane is an assistant editor at TNR Online.

March 21, 2002

http://www.thenewrepublic.com/doc.mhtml?i=express & s=culhane031802

Favor of the Month

Did the White House give the drug industry veto power over

FDA appointments?

by Christiane Culhane

Only at TNR Online | Post date 03.18.02 E-mail this

article

Perhaps because there's been so much coverage of campaign

finance reform to distract reporters, some important--and

disturbing--stories of apparent special influence have

managed to escape the media's normally harsh glare.

One such story is the tale of Alastair Wood, who was the

leading candidate to take over the Food and Drug

Administration (FDA) until the White House pulled his name

from contention last month.

Few agencies have a mandate to regulate such a broad swath

of American life as the FDA, which oversees products that

amount to one quarter of the nation's consumer economy and

80 percent of the nation's food supply. And few agencies

find themselves routinely mired in such high-profile

controversies. In the last few years, the FDA and its

officials have been major players in the debates over

tobacco, food safety, and the rules governing the

pharmaceutical industry.

It was Wood's expertise on the topic of drugs that made him

a promising candidate to run the FDA. A pharmacologist and

assistant vice chancellor at the Vanderbilt University

School of Medicine, Wood has spent his " entire professional

life studying and writing about drugs, " as he said in

recent

congressional testimony. He is the Drug Therapy editor for

perhaps the most prestigious medical publication in the

country, the New England Journal of Medicine, and he has

served on several FDA advisory committees.

Well-regarded by his peers, Wood has said he's particularly

interested in the way our increased understanding of the

human genome will lead to new drug discoveries, which in

turn will necessitate " paradigm shifts in the way we think

about evaluation of safety and efficacy. " When the Bush

administration let it be known that they were considering

Wood as their top candidate to head up the FDA, the choice

was hailed even by some of the administration's harshest

critics. As one such person, Public Citizen's Sidney Wolfe,

told me recently, Wood " should be the ideal candidate. "

Unfortunately, when it comes to health care issues, anybody

who makes folks like Sid Wolfe happy is bound to make

certain entrenched interests unhappy. That was certainly

true in Wood's case. And, unfortunately for him, the

special interest he antagonized was the pharmaceutical

industry.

For example, Wood has advocated for switching several

prescription drugs to over-the-counter status--a move that

would cost drug companies millions. (Pharmaceutical

companies can charge more for prescription drugs since

insurance companies are paying for them, shielding

consumers from the direct costs.) Wood says he is in favor

of extensive post-market surveillance of pharmaceuticals in

order to reassess safety and efficacy on an ongoing

basis. Wood notes (rightly) that monitoring drugs even

after initial approval can only help the pharmaceutical

industry in the long run, by preventing would-be disasters

(which might hurt the industry far more than a few recalls)

and giving the FDA more data on which to base its initial

assessments. " The greater our confidence in the ability to

generate quality post-marketing data, " Wood says, " the

greater our ability to approve drugs earlier. "

The idea that an FDA commissioner might from time to time

take positions at odds with the pharmaceutical industry

shouldn't be a liability; it ought to be an asset, given

the agency's role. But this particular administration has

reasons to think differently. In the 2000 election, the

pharmaceutical industry gave W. Bush $472,333, more

than four times the amount they gave to Al Gore, according

to the Center for Responsive Politics. During the

same election cycle, 96 percent of the soft money donations

from PhRMA (the Pharmaceutical Researchers and

Manufacturers of America) went to the Republicans. (Don't

forget, too, that Mitch s was an executive at Eli

Lilly, the pharmaceutical manufacturer, before he became

Bush's budget

director.)

When I called PhRMA, they insisted they had no position on

Wood's nomination. But the industry has made no secret

about their opposition to his ideas. And even if PhRMA

never said a word to anybody in the administration, those

donations alone would have been enough to make the White

House think twice before nominating somebody whom the

industry seemed

to find so objectionable. Indeed, when the White House

called Wood in late February to inform him that he was no

longer under consideration for the post, FDA watchers in

the public interest community and on Capitol Hill took

it for granted that Bush pulled back on the Wood nomination

because drug makers had a problem with it. As Jim Manley,

spokesperson for Senator Kennedy's office, said, " the

reality is that this is a pro-business Republican

administration that is very favorable to industry. " The

White House, naturally, insists it is merely looking for

the most qualified candidate. But given Wood's sterling

credentials, it's hard to imagine drug industry sentiments

didn't have something to do with it.

The problem for the White House is that this still leaves

them short one FDA commissioner nominee. And if the

administration now turns around and appoints somebody more

friendly to the pharmaceutical industry, it's bound

to raise the ire of Senate Democrats, who control the

nomination process and are already steamed about what

happened to Wood. So far, the administration has decided to

deal with this problem by not dealing with it at all. Bush

has simply appointed a deputy director--who doesn't need

Senate confirmation--and asked him to serve as acting

commissioner if, er, when the White House gets around to

appointing somebody permanently.

That appointee is Lester Crawford. A former inspections

administrator in the Department of Agriculture who's now

director of the town University Center for Food and

Nutrition, his expertise is food safety--a topic of much

greater relevance these days thanks to concerns about

bioterrorism. But Crawford is a veterinarian by training,

marking the first time in 20 years that the person running

the FDA does not have an " M.D. " after his name. Does

that make him less qualified to run the agency? A few

liberal critics think so. Then again, when pleasing the

pharmaceutical industry is a criteria for choosing FDA

officials, it's hard to be choosy.

Christiane Culhane is an assistant editor at TNR Online.

March 22, 2002

In a message dated 3/21/02 10:04:31 PM Mountain Standard Time, ccreel@... writes:

But Crawford is a veterinarian by training,

marking the first time in 20 years that the person running

the FDA does not have an "M.D." after his name. Does

that make him less qualified to run the agency? A few

liberal critics think so. Then again, when pleasing the

pharmaceutical industry is a criteria for choosing FDA

officials, it's hard to be choosy.

This is RICH!!! I've often said that we'd have all been better off going to a vet than going to some of the doctors we've been to. And let's face it, the pharmas want a whore-for-hire, a handmaiden to do their bidding. Sheesh!!!

March 22, 2002

In a message dated 3/21/02 10:04:31 PM Mountain Standard Time, ccreel@... writes:

But Crawford is a veterinarian by training,

marking the first time in 20 years that the person running

the FDA does not have an "M.D." after his name. Does

that make him less qualified to run the agency? A few

liberal critics think so. Then again, when pleasing the

pharmaceutical industry is a criteria for choosing FDA

officials, it's hard to be choosy.

This is RICH!!! I've often said that we'd have all been better off going to a vet than going to some of the doctors we've been to. And let's face it, the pharmas want a whore-for-hire, a handmaiden to do their bidding. Sheesh!!!

March 22, 2002

In a message dated 3/21/02 10:04:31 PM Mountain Standard Time, ccreel@... writes:

But Crawford is a veterinarian by training,

marking the first time in 20 years that the person running

the FDA does not have an "M.D." after his name. Does

that make him less qualified to run the agency? A few

liberal critics think so. Then again, when pleasing the

pharmaceutical industry is a criteria for choosing FDA

officials, it's hard to be choosy.

This is RICH!!! I've often said that we'd have all been better off going to a vet than going to some of the doctors we've been to. And let's face it, the pharmas want a whore-for-hire, a handmaiden to do their bidding. Sheesh!!!

March 22, 2002

In a message dated 3/21/02 10:04:31 PM Mountain Standard Time, ccreel@... writes:

But Crawford is a veterinarian by training,

marking the first time in 20 years that the person running

the FDA does not have an "M.D." after his name. Does

that make him less qualified to run the agency? A few

liberal critics think so. Then again, when pleasing the

pharmaceutical industry is a criteria for choosing FDA

officials, it's hard to be choosy.

This is RICH!!! I've often said that we'd have all been better off going to a vet than going to some of the doctors we've been to. And let's face it, the pharmas want a whore-for-hire, a handmaiden to do their bidding. Sheesh!!!

March 22, 2002

Dear Glitter,

You said:

<<This is RICH!!! I've often said that we'd have all been better off going

to a vet than going to some of the doctors we've been to. And let's face

it, the pharmas want a whore-for-hire, a handmaiden to do their bidding.

Sheesh!!! >>

LOL, I agree. Unfortunately, this guy is backed by the pharma industry.

Regards,

March 22, 2002

Dear Glitter,

You said:

<<This is RICH!!! I've often said that we'd have all been better off going

to a vet than going to some of the doctors we've been to. And let's face

it, the pharmas want a whore-for-hire, a handmaiden to do their bidding.

Sheesh!!! >>

LOL, I agree. Unfortunately, this guy is backed by the pharma industry.

Regards,

March 22, 2002

Dear Glitter,

You said:

<<This is RICH!!! I've often said that we'd have all been better off going

to a vet than going to some of the doctors we've been to. And let's face

it, the pharmas want a whore-for-hire, a handmaiden to do their bidding.

Sheesh!!! >>

LOL, I agree. Unfortunately, this guy is backed by the pharma industry.

Regards,

March 22, 2002

Dear Glitter,

You said:

<<This is RICH!!! I've often said that we'd have all been better off going

to a vet than going to some of the doctors we've been to. And let's face

it, the pharmas want a whore-for-hire, a handmaiden to do their bidding.

Sheesh!!! >>

LOL, I agree. Unfortunately, this guy is backed by the pharma industry.

Regards,

March 22, 2002

Right on Glitter. I'd trust my Vet any day over any md. She is

studying holistic healing methods for pets, is against

over-vaccinating animals and was one of the first in the county to

increase awareness among other local vets (re: vaccines)and besides

that she saved my cat's life. And her love for animals really shows.

this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......

optimistically pessimistic,

stinky

> In a message dated 3/21/02 10:04:31 PM Mountain Standard Time,

> ccreel@m... writes:

>

> > But Crawford is a veterinarian by training,

> > marking the first time in 20 years that the person running

> > the FDA does not have an " M.D. " after his name. Does

> > that make him less qualified to run the agency? A few

> > liberal critics think so. Then again, when pleasing the

> > pharmaceutical industry is a criteria for choosing FDA

> > officials, it's hard to be choosy.

> >

> > This is RICH!!! I've often said that we'd have all been better

off going

> > to a vet than going to some of the doctors we've been to. And

let's face

> > it, the pharmas want a whore-for-hire, a handmaiden to do their

bidding.

> >

March 22, 2002

Right on Glitter. I'd trust my Vet any day over any md. She is

studying holistic healing methods for pets, is against

over-vaccinating animals and was one of the first in the county to

increase awareness among other local vets (re: vaccines)and besides

that she saved my cat's life. And her love for animals really shows.

this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......

optimistically pessimistic,

stinky

> In a message dated 3/21/02 10:04:31 PM Mountain Standard Time,

> ccreel@m... writes:

>

> > But Crawford is a veterinarian by training,

> > marking the first time in 20 years that the person running

> > the FDA does not have an " M.D. " after his name. Does

> > that make him less qualified to run the agency? A few

> > liberal critics think so. Then again, when pleasing the

> > pharmaceutical industry is a criteria for choosing FDA

> > officials, it's hard to be choosy.

> >

> > This is RICH!!! I've often said that we'd have all been better

off going

> > to a vet than going to some of the doctors we've been to. And

let's face

> > it, the pharmas want a whore-for-hire, a handmaiden to do their

bidding.

> >

March 22, 2002

Right on Glitter. I'd trust my Vet any day over any md. She is

studying holistic healing methods for pets, is against

over-vaccinating animals and was one of the first in the county to

increase awareness among other local vets (re: vaccines)and besides

that she saved my cat's life. And her love for animals really shows.

this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......

optimistically pessimistic,

stinky

> In a message dated 3/21/02 10:04:31 PM Mountain Standard Time,

> ccreel@m... writes:

>

> > But Crawford is a veterinarian by training,

> > marking the first time in 20 years that the person running

> > the FDA does not have an " M.D. " after his name. Does

> > that make him less qualified to run the agency? A few

> > liberal critics think so. Then again, when pleasing the

> > pharmaceutical industry is a criteria for choosing FDA

> > officials, it's hard to be choosy.

> >

> > This is RICH!!! I've often said that we'd have all been better

off going

> > to a vet than going to some of the doctors we've been to. And

let's face

> > it, the pharmas want a whore-for-hire, a handmaiden to do their

bidding.

> >

March 22, 2002

Right on Glitter. I'd trust my Vet any day over any md. She is

studying holistic healing methods for pets, is against

over-vaccinating animals and was one of the first in the county to

increase awareness among other local vets (re: vaccines)and besides

that she saved my cat's life. And her love for animals really shows.

this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......

optimistically pessimistic,

stinky

> In a message dated 3/21/02 10:04:31 PM Mountain Standard Time,

> ccreel@m... writes:

>

> > But Crawford is a veterinarian by training,

> > marking the first time in 20 years that the person running

> > the FDA does not have an " M.D. " after his name. Does

> > that make him less qualified to run the agency? A few

> > liberal critics think so. Then again, when pleasing the

> > pharmaceutical industry is a criteria for choosing FDA

> > officials, it's hard to be choosy.

> >

> > This is RICH!!! I've often said that we'd have all been better

off going

> > to a vet than going to some of the doctors we've been to. And

let's face

> > it, the pharmas want a whore-for-hire, a handmaiden to do their

bidding.

> >

March 22, 2002

Hi Stinky,

You said:

<<this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......>>

He's not a good guy...the guy they almost approved and then

didn't was the good guy. This guy is the choice of the drug industry.

Regards,

March 22, 2002

Hi Stinky,

You said:

<<this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......>>

He's not a good guy...the guy they almost approved and then

didn't was the good guy. This guy is the choice of the drug industry.

Regards,

March 22, 2002

Hi Stinky,

You said:

<<this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......>>

He's not a good guy...the guy they almost approved and then

didn't was the good guy. This guy is the choice of the drug industry.

Regards,

March 22, 2002

Hi Stinky,

You said:

<<this poor guy has his work cut out for him. we can only hope that he

is a good guy and doesn't get poisoned by the bad guys. The fact that

he was chosen in the first place is an indication to me that he has

probably already been bought. but time will tell all......>>

He's not a good guy...the guy they almost approved and then

didn't was the good guy. This guy is the choice of the drug industry.

Regards,

March 22, 2002

> He's not a good guy...the guy they almost approved and then

> didn't was the good guy. This guy is the choice of the drug

industry.

> Regards,

>

Agree 100% ~ attempting to call the FDA and Pharma to account is one

thing; expecting, or even hoping, they will come clean on their own

is ludicrous: too much gold in them 'thar hills, er, ivory towers.

Though I have only dealt in the small confines of our research group

on the Wellbutrin/Zyban, we had the head honcho of a well know

university sell us down the river for pharma bucks in exchange for

dropping our research which had all but been signed, sealed and

delivered. All these guys are the same, and the ones who dare to be

different ~ well, they don't get the positions of " power " ,or, should

they cough up the goods, are black-balled. It's the good 'ol boy

syndrome in suits and ties ~ same mentality (or should I say lack

thereof!)

Collissa~

March 22, 2002