ANTIDEPRESSANTS Officials Swallow Industry Claims

[Guest guest]

Here is a good article on how the US has gotten into the mind-altering drug

advertisments.

10 million children on antidepressants. Oh my god! Jim

http://www.latimes.com/news/opinion/commentary/la-op-critser13jun13,1,6586146.st\

ory?coll=la-news-comment-opinions

ANTIDEPRESSANTS

Officials Swallow Industry Claims

By Greg Critser

Greg Critser, the author of " Fat Land: How Americans Became the Fattest People

in the World, " is writing a book about the pharmaceuticals industry.

June 13, 2004

Antidepressants are back in the news, with Americans, as usual, being tormented

by contradictory messages about the drugs, now prescribed to more than 10

million children and adolescents annually, largely without FDA approval.

Early this month, the National Institute of Mental Health issued a study showing

that one member of the family of antidepressants known as selective serotonin

reuptake inhibitors, or SSRIs, was effective for treating adolescent depression.

That was comforting.

The next day, the attorney general of New York sued GlaxoKline, the maker

of another SSRI, Paxil, for fraud, saying the firm had covered up unappealing

safety problems in kids who took the medication, including some who had

experienced suicidal thoughts or committed suicidal acts.

That wasn't so comforting.

The reasons behind these conflicting messages can and do fill millions of pages

of legal briefs and clinical trial reports, with varying levels of clarity and

veracity in both domains. But on the wider question - how did it become so easy

for a drug firm to promote its wares for unapproved uses? - the answer is

stunningly clear: Drug companies now enjoy the same license to promote their

products that the food, beverage and, until recently, tobacco industries have

enjoyed for decades. And for that we have two institutions to thank: the Supreme

Court and the Food and Drug Administration.

Liberals and consumer activists might be surprised to learn that a series of

court cases initiated by Ralph Nader in the 1970s gave rise to today's reigning

legal notions about commercial speech, which supply the legal framework for such

things as off-label promotion of drugs (the marketing to doctors of medications

for uses other than those approved by the FDA) and direct-to-consumer

advertising of prescription drugs.

In a 1976 case known as Virginia State Board of Pharmacy, Nader's attorneys

argued that consumers were entitled to information about drug prices - to be

able to shop for the best price - and that state laws that barred pharmacy

advertising violated " the consumer's right to know. "

Except for Justice H. Rehnquist, the court agreed, establishing the

consumer's right to know, or, more broadly, the listener's " right to hear " all

information, commercial or political.

The doctrine slowly worked its way through business and regulatory agencies, but

the FDA was still able to retain its control over claims made for a drug's

safety and efficacy. And, under that umbrella, the agency fiercely protected its

ability to regulate off-label promotion. The practice was - and still is -

illegal, but what is and isn't legal has gotten murkier.

Should a drug company be able to distribute, via highly trained and restrained

medical affairs people, studies showing that a drug approved for one purpose

also " seems " to help kids with, say, end-stage brain cancer, an unapproved use?

The average consumer would probably say yes. But the waters quickly get muddier.

Should a drug company be allowed, as has been the case with antidepressants, to

dispatch tens of thousands of young, barely trained sales reps, most just out of

college, to give general practitioners - many with no experience in psychiatric

medications - studies that " suggest " that adult antidepressants " might " help

kids with depression? The FDA's traditional response was to come down hard on

the latter but not on the former, and most of us would be likely to agree with

that inclination.

But beginning in the early 1990s, a new generation of legal activists, many

working for the broadcast and advertising industries, instituted a wave of

commercial speech cases, which, though not specifically aimed at curtailing the

FDA's power to regulate off-label promotion, had that effect.

One such case took aim at a Rhode Island law that prohibited advertising the

price of liquor except at the point of purchase. Arguing a strict

constructionist theory in front of an increasingly conservative, strict

constructionist court, conservative activist attorney E. Troy, who once

clerked for Judge Bork, focused on the intentions of the founding fathers

when it came to the 1st Amendment and advertising. Citing a range of colonial

newspapers, their publishers and leading Revolutionary War-era thinkers,

including lin, Troy told the court that " colonial Americans

plainly viewed the freedom of speech as protecting far more than just political

speech. "

This lack of distinction between commercial and political speech was important

because most colonial newspapers were primarily vehicles for advertising, hardly

the impartial beacons that modern papers are expected to be, but Troy did not

dwell on that technicality. Instead, he told the court that " there is no

evidence on the other side - nothing at all - to suggest that, as an original

matter, commercial messages should be treated differently from other types of

messages. "

The court was unanimous in striking down the Rhode Island law, with Justice

Antonin Scalia writing about his " aversion toward paternalistic governmental

policies that prevent men and women from hearing facts that might not be good

for them. "

In 1999, the same doctrine was invoked in another action, this one in a district

court case specifically involving off-label promotion of prescription drugs. The

case had been brought by the conservative Washington Legal Foundation, which was

partly funded by advertising trade groups. In this case, Troy, working beside

attorneys for the foundation, argued the same line, but the key to the win was

the anti-paternalism argument.

The government " cannot justify a restriction of truthful, non-misleading speech

on the paternalistic assumption that such restriction is necessary to protect

the listener from ignorantly or inadvertently misusing the information, " the

court wrote. With that ruling, the " consumer's right to know " - Nader's great

triumph of the 1970s - became the corporation's right to " subtly encourage. "

The FDA's response was to embrace the decision. Soon, advocating the regulation

of anything but the most over-the-top and misleading drug promotion activity was

viewed, internally, as a career-killing move. The Division of Drug Marketing,

Advertising and Communications, the tiny department charged with such

regulation, was routinely underfunded and rife with institutional

second-guessing. This year, a congressional report found that in 2003 the

division issued drug makers 75% fewer warning letters, its chief enforcement

device, than during the last two years of the Clinton administration. Even the

pharmaceuticals trade press was stunned by the change, noting in one headline

that " most medical promotion is out of sight of regulators. "

The FDA's tolerance of drug company product promotion reached new heights under

Bush appointee Mark McClellan, until March the agency's chief. McClellan made

clear to the pharmaceutical industry immediately after his appointment that he

intended to change the FDA's image. Under him, that image morphed from one of a

tough, independent-minded regulatory body to a partner in nurturing

pharmaceutical innovation. On the January 2004 cover of Medical Marketing &

Media, for example, then-Commissioner McClellan could be found with Pitts,

his new public affairs director, alongside the headline, " We won't bite. "

In an interview inside the magazine, Pitts bragged about how he had welcomed

visiting drug representatives, even offering to edit advertising and

communication proposals before the agency. Pitts and McClellan have since been

ubiquitous on the (unpaid) pharmaceuticals industry speakers' circuits,

appearing at marketing confabs that promise to teach attendees things like " how

to push the promotional envelope. " (McClellan is probably less desired nowadays

because he has ended his once-virulent anti-imports stance since being named

head of the Medicare agency.)

But even if a new commissioner decides to again get tough on off-label

promotions, the agency would seem to have little leeway left to regulate

commercial speech unless it's demonstrably false. And the agency's chief legal

counsel is unlikely to push the envelope because the FDA's top lawyer is now .

Dan Troy.

Will the responsibility of public life reshape Troy's thinking? Apparently not.

One of his first acts in office was to file a " friend of the court " brief in two

legal cases involving antidepressants. In both, he entered on the side of the

industry.

If you want other stories on this topic, search the Archives at

latimes.com/archives.

Article licensing and reprint options

Copyright 2004 Los Angeles Times

[Guest guest]

Here is a good article on how the US has gotten into the mind-altering drug

advertisments.

10 million children on antidepressants. Oh my god! Jim

http://www.latimes.com/news/opinion/commentary/la-op-critser13jun13,1,6586146.st\

ory?coll=la-news-comment-opinions

ANTIDEPRESSANTS

Officials Swallow Industry Claims

By Greg Critser

Greg Critser, the author of " Fat Land: How Americans Became the Fattest People

in the World, " is writing a book about the pharmaceuticals industry.

June 13, 2004

Antidepressants are back in the news, with Americans, as usual, being tormented

by contradictory messages about the drugs, now prescribed to more than 10

million children and adolescents annually, largely without FDA approval.

Early this month, the National Institute of Mental Health issued a study showing

that one member of the family of antidepressants known as selective serotonin

reuptake inhibitors, or SSRIs, was effective for treating adolescent depression.

That was comforting.

The next day, the attorney general of New York sued GlaxoKline, the maker

of another SSRI, Paxil, for fraud, saying the firm had covered up unappealing

safety problems in kids who took the medication, including some who had

experienced suicidal thoughts or committed suicidal acts.

That wasn't so comforting.

The reasons behind these conflicting messages can and do fill millions of pages

of legal briefs and clinical trial reports, with varying levels of clarity and

veracity in both domains. But on the wider question - how did it become so easy

for a drug firm to promote its wares for unapproved uses? - the answer is

stunningly clear: Drug companies now enjoy the same license to promote their

products that the food, beverage and, until recently, tobacco industries have

enjoyed for decades. And for that we have two institutions to thank: the Supreme

Court and the Food and Drug Administration.

Liberals and consumer activists might be surprised to learn that a series of

court cases initiated by Ralph Nader in the 1970s gave rise to today's reigning

legal notions about commercial speech, which supply the legal framework for such

things as off-label promotion of drugs (the marketing to doctors of medications

for uses other than those approved by the FDA) and direct-to-consumer

advertising of prescription drugs.

In a 1976 case known as Virginia State Board of Pharmacy, Nader's attorneys

argued that consumers were entitled to information about drug prices - to be

able to shop for the best price - and that state laws that barred pharmacy

advertising violated " the consumer's right to know. "

Except for Justice H. Rehnquist, the court agreed, establishing the

consumer's right to know, or, more broadly, the listener's " right to hear " all

information, commercial or political.

The doctrine slowly worked its way through business and regulatory agencies, but

the FDA was still able to retain its control over claims made for a drug's

safety and efficacy. And, under that umbrella, the agency fiercely protected its

ability to regulate off-label promotion. The practice was - and still is -

illegal, but what is and isn't legal has gotten murkier.

Should a drug company be able to distribute, via highly trained and restrained

medical affairs people, studies showing that a drug approved for one purpose

also " seems " to help kids with, say, end-stage brain cancer, an unapproved use?

The average consumer would probably say yes. But the waters quickly get muddier.

Should a drug company be allowed, as has been the case with antidepressants, to

dispatch tens of thousands of young, barely trained sales reps, most just out of

college, to give general practitioners - many with no experience in psychiatric

medications - studies that " suggest " that adult antidepressants " might " help

kids with depression? The FDA's traditional response was to come down hard on

the latter but not on the former, and most of us would be likely to agree with

that inclination.

But beginning in the early 1990s, a new generation of legal activists, many

working for the broadcast and advertising industries, instituted a wave of

commercial speech cases, which, though not specifically aimed at curtailing the

FDA's power to regulate off-label promotion, had that effect.

One such case took aim at a Rhode Island law that prohibited advertising the

price of liquor except at the point of purchase. Arguing a strict

constructionist theory in front of an increasingly conservative, strict

constructionist court, conservative activist attorney E. Troy, who once

clerked for Judge Bork, focused on the intentions of the founding fathers

when it came to the 1st Amendment and advertising. Citing a range of colonial

newspapers, their publishers and leading Revolutionary War-era thinkers,

including lin, Troy told the court that " colonial Americans

plainly viewed the freedom of speech as protecting far more than just political

speech. "

This lack of distinction between commercial and political speech was important

because most colonial newspapers were primarily vehicles for advertising, hardly

the impartial beacons that modern papers are expected to be, but Troy did not

dwell on that technicality. Instead, he told the court that " there is no

evidence on the other side - nothing at all - to suggest that, as an original

matter, commercial messages should be treated differently from other types of

messages. "

The court was unanimous in striking down the Rhode Island law, with Justice

Antonin Scalia writing about his " aversion toward paternalistic governmental

policies that prevent men and women from hearing facts that might not be good

for them. "

In 1999, the same doctrine was invoked in another action, this one in a district

court case specifically involving off-label promotion of prescription drugs. The

case had been brought by the conservative Washington Legal Foundation, which was

partly funded by advertising trade groups. In this case, Troy, working beside

attorneys for the foundation, argued the same line, but the key to the win was

the anti-paternalism argument.

The government " cannot justify a restriction of truthful, non-misleading speech

on the paternalistic assumption that such restriction is necessary to protect

the listener from ignorantly or inadvertently misusing the information, " the

court wrote. With that ruling, the " consumer's right to know " - Nader's great

triumph of the 1970s - became the corporation's right to " subtly encourage. "

The FDA's response was to embrace the decision. Soon, advocating the regulation

of anything but the most over-the-top and misleading drug promotion activity was

viewed, internally, as a career-killing move. The Division of Drug Marketing,

Advertising and Communications, the tiny department charged with such

regulation, was routinely underfunded and rife with institutional

second-guessing. This year, a congressional report found that in 2003 the

division issued drug makers 75% fewer warning letters, its chief enforcement

device, than during the last two years of the Clinton administration. Even the

pharmaceuticals trade press was stunned by the change, noting in one headline

that " most medical promotion is out of sight of regulators. "

The FDA's tolerance of drug company product promotion reached new heights under

Bush appointee Mark McClellan, until March the agency's chief. McClellan made

clear to the pharmaceutical industry immediately after his appointment that he

intended to change the FDA's image. Under him, that image morphed from one of a

tough, independent-minded regulatory body to a partner in nurturing

pharmaceutical innovation. On the January 2004 cover of Medical Marketing &

Media, for example, then-Commissioner McClellan could be found with Pitts,

his new public affairs director, alongside the headline, " We won't bite. "

In an interview inside the magazine, Pitts bragged about how he had welcomed

visiting drug representatives, even offering to edit advertising and

communication proposals before the agency. Pitts and McClellan have since been

ubiquitous on the (unpaid) pharmaceuticals industry speakers' circuits,

appearing at marketing confabs that promise to teach attendees things like " how

to push the promotional envelope. " (McClellan is probably less desired nowadays

because he has ended his once-virulent anti-imports stance since being named

head of the Medicare agency.)

But even if a new commissioner decides to again get tough on off-label

promotions, the agency would seem to have little leeway left to regulate

commercial speech unless it's demonstrably false. And the agency's chief legal

counsel is unlikely to push the envelope because the FDA's top lawyer is now .

Dan Troy.

Will the responsibility of public life reshape Troy's thinking? Apparently not.

One of his first acts in office was to file a " friend of the court " brief in two

legal cases involving antidepressants. In both, he entered on the side of the

industry.

If you want other stories on this topic, search the Archives at

latimes.com/archives.

Article licensing and reprint options

Copyright 2004 Los Angeles Times

[Guest guest]

Here is a good article on how the US has gotten into the mind-altering drug

advertisments.

10 million children on antidepressants. Oh my god! Jim

http://www.latimes.com/news/opinion/commentary/la-op-critser13jun13,1,6586146.st\

ory?coll=la-news-comment-opinions

ANTIDEPRESSANTS

Officials Swallow Industry Claims

By Greg Critser

Greg Critser, the author of " Fat Land: How Americans Became the Fattest People

in the World, " is writing a book about the pharmaceuticals industry.

June 13, 2004

Antidepressants are back in the news, with Americans, as usual, being tormented

by contradictory messages about the drugs, now prescribed to more than 10

million children and adolescents annually, largely without FDA approval.

Early this month, the National Institute of Mental Health issued a study showing

that one member of the family of antidepressants known as selective serotonin

reuptake inhibitors, or SSRIs, was effective for treating adolescent depression.

That was comforting.

The next day, the attorney general of New York sued GlaxoKline, the maker

of another SSRI, Paxil, for fraud, saying the firm had covered up unappealing

safety problems in kids who took the medication, including some who had

experienced suicidal thoughts or committed suicidal acts.

That wasn't so comforting.

The reasons behind these conflicting messages can and do fill millions of pages

of legal briefs and clinical trial reports, with varying levels of clarity and

veracity in both domains. But on the wider question - how did it become so easy

for a drug firm to promote its wares for unapproved uses? - the answer is

stunningly clear: Drug companies now enjoy the same license to promote their

products that the food, beverage and, until recently, tobacco industries have

enjoyed for decades. And for that we have two institutions to thank: the Supreme

Court and the Food and Drug Administration.

Liberals and consumer activists might be surprised to learn that a series of

court cases initiated by Ralph Nader in the 1970s gave rise to today's reigning

legal notions about commercial speech, which supply the legal framework for such

things as off-label promotion of drugs (the marketing to doctors of medications

for uses other than those approved by the FDA) and direct-to-consumer

advertising of prescription drugs.

In a 1976 case known as Virginia State Board of Pharmacy, Nader's attorneys

argued that consumers were entitled to information about drug prices - to be

able to shop for the best price - and that state laws that barred pharmacy

advertising violated " the consumer's right to know. "

Except for Justice H. Rehnquist, the court agreed, establishing the

consumer's right to know, or, more broadly, the listener's " right to hear " all

information, commercial or political.

The doctrine slowly worked its way through business and regulatory agencies, but

the FDA was still able to retain its control over claims made for a drug's

safety and efficacy. And, under that umbrella, the agency fiercely protected its

ability to regulate off-label promotion. The practice was - and still is -

illegal, but what is and isn't legal has gotten murkier.

Should a drug company be able to distribute, via highly trained and restrained

medical affairs people, studies showing that a drug approved for one purpose

also " seems " to help kids with, say, end-stage brain cancer, an unapproved use?

The average consumer would probably say yes. But the waters quickly get muddier.

Should a drug company be allowed, as has been the case with antidepressants, to

dispatch tens of thousands of young, barely trained sales reps, most just out of

college, to give general practitioners - many with no experience in psychiatric

medications - studies that " suggest " that adult antidepressants " might " help

kids with depression? The FDA's traditional response was to come down hard on

the latter but not on the former, and most of us would be likely to agree with

that inclination.

But beginning in the early 1990s, a new generation of legal activists, many

working for the broadcast and advertising industries, instituted a wave of

commercial speech cases, which, though not specifically aimed at curtailing the

FDA's power to regulate off-label promotion, had that effect.

One such case took aim at a Rhode Island law that prohibited advertising the

price of liquor except at the point of purchase. Arguing a strict

constructionist theory in front of an increasingly conservative, strict

constructionist court, conservative activist attorney E. Troy, who once

clerked for Judge Bork, focused on the intentions of the founding fathers

when it came to the 1st Amendment and advertising. Citing a range of colonial

newspapers, their publishers and leading Revolutionary War-era thinkers,

including lin, Troy told the court that " colonial Americans

plainly viewed the freedom of speech as protecting far more than just political

speech. "

This lack of distinction between commercial and political speech was important

because most colonial newspapers were primarily vehicles for advertising, hardly

the impartial beacons that modern papers are expected to be, but Troy did not

dwell on that technicality. Instead, he told the court that " there is no

evidence on the other side - nothing at all - to suggest that, as an original

matter, commercial messages should be treated differently from other types of

messages. "

The court was unanimous in striking down the Rhode Island law, with Justice

Antonin Scalia writing about his " aversion toward paternalistic governmental

policies that prevent men and women from hearing facts that might not be good

for them. "

In 1999, the same doctrine was invoked in another action, this one in a district

court case specifically involving off-label promotion of prescription drugs. The

case had been brought by the conservative Washington Legal Foundation, which was

partly funded by advertising trade groups. In this case, Troy, working beside

attorneys for the foundation, argued the same line, but the key to the win was

the anti-paternalism argument.

The government " cannot justify a restriction of truthful, non-misleading speech

on the paternalistic assumption that such restriction is necessary to protect

the listener from ignorantly or inadvertently misusing the information, " the

court wrote. With that ruling, the " consumer's right to know " - Nader's great

triumph of the 1970s - became the corporation's right to " subtly encourage. "

The FDA's response was to embrace the decision. Soon, advocating the regulation

of anything but the most over-the-top and misleading drug promotion activity was

viewed, internally, as a career-killing move. The Division of Drug Marketing,

Advertising and Communications, the tiny department charged with such

regulation, was routinely underfunded and rife with institutional

second-guessing. This year, a congressional report found that in 2003 the

division issued drug makers 75% fewer warning letters, its chief enforcement

device, than during the last two years of the Clinton administration. Even the

pharmaceuticals trade press was stunned by the change, noting in one headline

that " most medical promotion is out of sight of regulators. "

The FDA's tolerance of drug company product promotion reached new heights under

Bush appointee Mark McClellan, until March the agency's chief. McClellan made

clear to the pharmaceutical industry immediately after his appointment that he

intended to change the FDA's image. Under him, that image morphed from one of a

tough, independent-minded regulatory body to a partner in nurturing

pharmaceutical innovation. On the January 2004 cover of Medical Marketing &

Media, for example, then-Commissioner McClellan could be found with Pitts,

his new public affairs director, alongside the headline, " We won't bite. "

In an interview inside the magazine, Pitts bragged about how he had welcomed

visiting drug representatives, even offering to edit advertising and

communication proposals before the agency. Pitts and McClellan have since been

ubiquitous on the (unpaid) pharmaceuticals industry speakers' circuits,

appearing at marketing confabs that promise to teach attendees things like " how

to push the promotional envelope. " (McClellan is probably less desired nowadays

because he has ended his once-virulent anti-imports stance since being named

head of the Medicare agency.)

But even if a new commissioner decides to again get tough on off-label

promotions, the agency would seem to have little leeway left to regulate

commercial speech unless it's demonstrably false. And the agency's chief legal

counsel is unlikely to push the envelope because the FDA's top lawyer is now .

Dan Troy.

Will the responsibility of public life reshape Troy's thinking? Apparently not.

One of his first acts in office was to file a " friend of the court " brief in two

legal cases involving antidepressants. In both, he entered on the side of the

industry.

If you want other stories on this topic, search the Archives at

latimes.com/archives.

Article licensing and reprint options

Copyright 2004 Los Angeles Times

[Guest guest]

Here is a good article on how the US has gotten into the mind-altering drug

advertisments.

10 million children on antidepressants. Oh my god! Jim

http://www.latimes.com/news/opinion/commentary/la-op-critser13jun13,1,6586146.st\

ory?coll=la-news-comment-opinions

ANTIDEPRESSANTS

Officials Swallow Industry Claims

By Greg Critser

Greg Critser, the author of " Fat Land: How Americans Became the Fattest People

in the World, " is writing a book about the pharmaceuticals industry.

June 13, 2004

Antidepressants are back in the news, with Americans, as usual, being tormented

by contradictory messages about the drugs, now prescribed to more than 10

million children and adolescents annually, largely without FDA approval.

Early this month, the National Institute of Mental Health issued a study showing

that one member of the family of antidepressants known as selective serotonin

reuptake inhibitors, or SSRIs, was effective for treating adolescent depression.

That was comforting.

The next day, the attorney general of New York sued GlaxoKline, the maker

of another SSRI, Paxil, for fraud, saying the firm had covered up unappealing

safety problems in kids who took the medication, including some who had

experienced suicidal thoughts or committed suicidal acts.

That wasn't so comforting.

The reasons behind these conflicting messages can and do fill millions of pages

of legal briefs and clinical trial reports, with varying levels of clarity and

veracity in both domains. But on the wider question - how did it become so easy

for a drug firm to promote its wares for unapproved uses? - the answer is

stunningly clear: Drug companies now enjoy the same license to promote their

products that the food, beverage and, until recently, tobacco industries have

enjoyed for decades. And for that we have two institutions to thank: the Supreme

Court and the Food and Drug Administration.

Liberals and consumer activists might be surprised to learn that a series of

court cases initiated by Ralph Nader in the 1970s gave rise to today's reigning

legal notions about commercial speech, which supply the legal framework for such

things as off-label promotion of drugs (the marketing to doctors of medications

for uses other than those approved by the FDA) and direct-to-consumer

advertising of prescription drugs.

In a 1976 case known as Virginia State Board of Pharmacy, Nader's attorneys

argued that consumers were entitled to information about drug prices - to be

able to shop for the best price - and that state laws that barred pharmacy

advertising violated " the consumer's right to know. "

Except for Justice H. Rehnquist, the court agreed, establishing the

consumer's right to know, or, more broadly, the listener's " right to hear " all

information, commercial or political.

The doctrine slowly worked its way through business and regulatory agencies, but

the FDA was still able to retain its control over claims made for a drug's

safety and efficacy. And, under that umbrella, the agency fiercely protected its

ability to regulate off-label promotion. The practice was - and still is -

illegal, but what is and isn't legal has gotten murkier.

Should a drug company be able to distribute, via highly trained and restrained

medical affairs people, studies showing that a drug approved for one purpose

also " seems " to help kids with, say, end-stage brain cancer, an unapproved use?

The average consumer would probably say yes. But the waters quickly get muddier.

Should a drug company be allowed, as has been the case with antidepressants, to

dispatch tens of thousands of young, barely trained sales reps, most just out of

college, to give general practitioners - many with no experience in psychiatric

medications - studies that " suggest " that adult antidepressants " might " help

kids with depression? The FDA's traditional response was to come down hard on

the latter but not on the former, and most of us would be likely to agree with

that inclination.

But beginning in the early 1990s, a new generation of legal activists, many

working for the broadcast and advertising industries, instituted a wave of

commercial speech cases, which, though not specifically aimed at curtailing the

FDA's power to regulate off-label promotion, had that effect.

One such case took aim at a Rhode Island law that prohibited advertising the

price of liquor except at the point of purchase. Arguing a strict

constructionist theory in front of an increasingly conservative, strict

constructionist court, conservative activist attorney E. Troy, who once

clerked for Judge Bork, focused on the intentions of the founding fathers

when it came to the 1st Amendment and advertising. Citing a range of colonial

newspapers, their publishers and leading Revolutionary War-era thinkers,

including lin, Troy told the court that " colonial Americans

plainly viewed the freedom of speech as protecting far more than just political

speech. "

This lack of distinction between commercial and political speech was important

because most colonial newspapers were primarily vehicles for advertising, hardly

the impartial beacons that modern papers are expected to be, but Troy did not

dwell on that technicality. Instead, he told the court that " there is no

evidence on the other side - nothing at all - to suggest that, as an original

matter, commercial messages should be treated differently from other types of

messages. "

The court was unanimous in striking down the Rhode Island law, with Justice

Antonin Scalia writing about his " aversion toward paternalistic governmental

policies that prevent men and women from hearing facts that might not be good

for them. "

In 1999, the same doctrine was invoked in another action, this one in a district

court case specifically involving off-label promotion of prescription drugs. The

case had been brought by the conservative Washington Legal Foundation, which was

partly funded by advertising trade groups. In this case, Troy, working beside

attorneys for the foundation, argued the same line, but the key to the win was

the anti-paternalism argument.

The government " cannot justify a restriction of truthful, non-misleading speech

on the paternalistic assumption that such restriction is necessary to protect

the listener from ignorantly or inadvertently misusing the information, " the

court wrote. With that ruling, the " consumer's right to know " - Nader's great

triumph of the 1970s - became the corporation's right to " subtly encourage. "

The FDA's response was to embrace the decision. Soon, advocating the regulation

of anything but the most over-the-top and misleading drug promotion activity was

viewed, internally, as a career-killing move. The Division of Drug Marketing,

Advertising and Communications, the tiny department charged with such

regulation, was routinely underfunded and rife with institutional

second-guessing. This year, a congressional report found that in 2003 the

division issued drug makers 75% fewer warning letters, its chief enforcement

device, than during the last two years of the Clinton administration. Even the

pharmaceuticals trade press was stunned by the change, noting in one headline

that " most medical promotion is out of sight of regulators. "

The FDA's tolerance of drug company product promotion reached new heights under

Bush appointee Mark McClellan, until March the agency's chief. McClellan made

clear to the pharmaceutical industry immediately after his appointment that he

intended to change the FDA's image. Under him, that image morphed from one of a

tough, independent-minded regulatory body to a partner in nurturing

pharmaceutical innovation. On the January 2004 cover of Medical Marketing &

Media, for example, then-Commissioner McClellan could be found with Pitts,

his new public affairs director, alongside the headline, " We won't bite. "

In an interview inside the magazine, Pitts bragged about how he had welcomed

visiting drug representatives, even offering to edit advertising and

communication proposals before the agency. Pitts and McClellan have since been

ubiquitous on the (unpaid) pharmaceuticals industry speakers' circuits,

appearing at marketing confabs that promise to teach attendees things like " how

to push the promotional envelope. " (McClellan is probably less desired nowadays

because he has ended his once-virulent anti-imports stance since being named

head of the Medicare agency.)

But even if a new commissioner decides to again get tough on off-label

promotions, the agency would seem to have little leeway left to regulate

commercial speech unless it's demonstrably false. And the agency's chief legal

counsel is unlikely to push the envelope because the FDA's top lawyer is now .

Dan Troy.

Will the responsibility of public life reshape Troy's thinking? Apparently not.

One of his first acts in office was to file a " friend of the court " brief in two

legal cases involving antidepressants. In both, he entered on the side of the

industry.

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