This Drug Rep Says He Has a Right to Sell a Date-Rape Drug as a Diet Drink | BNET

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http://m.bnet.com/blog/drug-business/this-drug-rep-says-he-has-a-right-to-sell-a\

-date-rape-drug-as-a-diet-drink/6643?tag=content;drawer-container

A Jazz Pharmaceuticals (JAZZ) drug sales rep convicted for illegally promoting

the date-rape drug GHB as a weight-loss product has appealed his sentence on the

grounds that he had a First Amendment free speech right to speak the “truth”

about the drug.

If the federal appeals court rules in Alfred Caronia’s favor, it would virtually

decriminalize the promotion of unapproved, often dangerous, “off-label” uses of

pharmaceuticals. Previously, courts have rejected this specific argument, but

the federal judiciary is becoming increasingly sympathetic to wrongdoing by drug

companies in other cases.

The Caronia case shows exactly why there are good reasons off-label promotion

should remain illegal: Orphan Medical, the company Jazz acquired in 2005, paid

Dr. Gleason tens of thousands of dollars to travel the country giving

talks to other physicians about the miracle of Xyrem, the brand name under which

Jazz sells GHB. Xyrem is only approved to treat excessive daytime sleepiness in

patients with narcolepsy. Yet Gleason told doctors that Xyrem — a solution that

you drink — was also good for chronic pain, weight loss, depression, bipolar

disorders, fibromylagia, insomnia and Parkinson’s disease. According to the

indictment filed against Gleason and the Jazz drug rep who handled him, Caronia,

the pair also engaged in “deceptive and misleading behavior” by telling doctors

that:

GHB was not a date rape drug

GHB was never banned by the FDA

The FDA regarded Xyrem as a miracle treatment for narcolepsy

A patient could safely overdose on Xyrem without harmful effect

Table salt was more dangerous than Xyrem

Xyrem was safe for very young children

Gleason pled guilty. Caronia was found guilty by a jury. The case should be

closed but it’s being made into a cause celebre by the Washington Legal

Foundation, a right-wing think tank that believes drug companies have the right

to say whatever they want regardless of the consequences as long as they can

also claim they are speaking the “truth.” The WLF frequently acts as Big

Pharma’s litigation stalking horse. Its amicus brief to the appeals court is a

dense thicket of First Amendment law that doesn’t mention what Caronia actually

did.

Worse, WLF’s chief counsel, Samp, has taken advantage of Forbes‘ newly

lax standards for expert bloggers to write about the case under that magazine’s

brand in a manner that suggests the only issue at stake is the free speech

rights of drug company employees. The blog does not specifically state that Samp

is writing about his own case and a client with whom he sympathizes:

FDA apparently is beginning to recognize that First Amendment challenges to its

authority are being taken seriously by the federal courts.

That’s misleading because the last time the FDA said or did anything about

Xyrem, it rejected the drug for use as a treatment for fibromyalgia — one of the

off-label uses promoted by Caronia and Gleason. In fact, the Jazz or the FDA

believed that Xyrem had any use for conditions such as depression or being too

fat, it would be approved for those purposes.

Both Caronia and Gleason received one year probation for their crimes. That

seems generous considering how dangerous Xyrem is when it falls into the wrong

hands. The drug is so risky it can only be marketed alongside a security system

that guards against recreational — or criminal — use. Why the WLF wants to make

this a common and accepted industry practice is anyone’s guess.

Sent via BlackBerry by AT & T

[Guest guest]

http://m.bnet.com/blog/drug-business/this-drug-rep-says-he-has-a-right-to-sell-a\

-date-rape-drug-as-a-diet-drink/6643?tag=content;drawer-container

A Jazz Pharmaceuticals (JAZZ) drug sales rep convicted for illegally promoting

the date-rape drug GHB as a weight-loss product has appealed his sentence on the

grounds that he had a First Amendment free speech right to speak the “truth”

about the drug.

If the federal appeals court rules in Alfred Caronia’s favor, it would virtually

decriminalize the promotion of unapproved, often dangerous, “off-label” uses of

pharmaceuticals. Previously, courts have rejected this specific argument, but

the federal judiciary is becoming increasingly sympathetic to wrongdoing by drug

companies in other cases.

The Caronia case shows exactly why there are good reasons off-label promotion

should remain illegal: Orphan Medical, the company Jazz acquired in 2005, paid

Dr. Gleason tens of thousands of dollars to travel the country giving

talks to other physicians about the miracle of Xyrem, the brand name under which

Jazz sells GHB. Xyrem is only approved to treat excessive daytime sleepiness in

patients with narcolepsy. Yet Gleason told doctors that Xyrem — a solution that

you drink — was also good for chronic pain, weight loss, depression, bipolar

disorders, fibromylagia, insomnia and Parkinson’s disease. According to the

indictment filed against Gleason and the Jazz drug rep who handled him, Caronia,

the pair also engaged in “deceptive and misleading behavior” by telling doctors

that:

GHB was not a date rape drug

GHB was never banned by the FDA

The FDA regarded Xyrem as a miracle treatment for narcolepsy

A patient could safely overdose on Xyrem without harmful effect

Table salt was more dangerous than Xyrem

Xyrem was safe for very young children

Gleason pled guilty. Caronia was found guilty by a jury. The case should be

closed but it’s being made into a cause celebre by the Washington Legal

Foundation, a right-wing think tank that believes drug companies have the right

to say whatever they want regardless of the consequences as long as they can

also claim they are speaking the “truth.” The WLF frequently acts as Big

Pharma’s litigation stalking horse. Its amicus brief to the appeals court is a

dense thicket of First Amendment law that doesn’t mention what Caronia actually

did.

Worse, WLF’s chief counsel, Samp, has taken advantage of Forbes‘ newly

lax standards for expert bloggers to write about the case under that magazine’s

brand in a manner that suggests the only issue at stake is the free speech

rights of drug company employees. The blog does not specifically state that Samp

is writing about his own case and a client with whom he sympathizes:

FDA apparently is beginning to recognize that First Amendment challenges to its

authority are being taken seriously by the federal courts.

That’s misleading because the last time the FDA said or did anything about

Xyrem, it rejected the drug for use as a treatment for fibromyalgia — one of the

off-label uses promoted by Caronia and Gleason. In fact, the Jazz or the FDA

believed that Xyrem had any use for conditions such as depression or being too

fat, it would be approved for those purposes.

Both Caronia and Gleason received one year probation for their crimes. That

seems generous considering how dangerous Xyrem is when it falls into the wrong

hands. The drug is so risky it can only be marketed alongside a security system

that guards against recreational — or criminal — use. Why the WLF wants to make

this a common and accepted industry practice is anyone’s guess.

Sent via BlackBerry by AT & T

[Guest guest]

http://m.bnet.com/blog/drug-business/this-drug-rep-says-he-has-a-right-to-sell-a\

-date-rape-drug-as-a-diet-drink/6643?tag=content;drawer-container

A Jazz Pharmaceuticals (JAZZ) drug sales rep convicted for illegally promoting

the date-rape drug GHB as a weight-loss product has appealed his sentence on the

grounds that he had a First Amendment free speech right to speak the “truth”

about the drug.

If the federal appeals court rules in Alfred Caronia’s favor, it would virtually

decriminalize the promotion of unapproved, often dangerous, “off-label” uses of

pharmaceuticals. Previously, courts have rejected this specific argument, but

the federal judiciary is becoming increasingly sympathetic to wrongdoing by drug

companies in other cases.

The Caronia case shows exactly why there are good reasons off-label promotion

should remain illegal: Orphan Medical, the company Jazz acquired in 2005, paid

Dr. Gleason tens of thousands of dollars to travel the country giving

talks to other physicians about the miracle of Xyrem, the brand name under which

Jazz sells GHB. Xyrem is only approved to treat excessive daytime sleepiness in

patients with narcolepsy. Yet Gleason told doctors that Xyrem — a solution that

you drink — was also good for chronic pain, weight loss, depression, bipolar

disorders, fibromylagia, insomnia and Parkinson’s disease. According to the

indictment filed against Gleason and the Jazz drug rep who handled him, Caronia,

the pair also engaged in “deceptive and misleading behavior” by telling doctors

that:

GHB was not a date rape drug

GHB was never banned by the FDA

The FDA regarded Xyrem as a miracle treatment for narcolepsy

A patient could safely overdose on Xyrem without harmful effect

Table salt was more dangerous than Xyrem

Xyrem was safe for very young children

Gleason pled guilty. Caronia was found guilty by a jury. The case should be

closed but it’s being made into a cause celebre by the Washington Legal

Foundation, a right-wing think tank that believes drug companies have the right

to say whatever they want regardless of the consequences as long as they can

also claim they are speaking the “truth.” The WLF frequently acts as Big

Pharma’s litigation stalking horse. Its amicus brief to the appeals court is a

dense thicket of First Amendment law that doesn’t mention what Caronia actually

did.

Worse, WLF’s chief counsel, Samp, has taken advantage of Forbes‘ newly

lax standards for expert bloggers to write about the case under that magazine’s

brand in a manner that suggests the only issue at stake is the free speech

rights of drug company employees. The blog does not specifically state that Samp

is writing about his own case and a client with whom he sympathizes:

FDA apparently is beginning to recognize that First Amendment challenges to its

authority are being taken seriously by the federal courts.

That’s misleading because the last time the FDA said or did anything about

Xyrem, it rejected the drug for use as a treatment for fibromyalgia — one of the

off-label uses promoted by Caronia and Gleason. In fact, the Jazz or the FDA

believed that Xyrem had any use for conditions such as depression or being too

fat, it would be approved for those purposes.

Both Caronia and Gleason received one year probation for their crimes. That

seems generous considering how dangerous Xyrem is when it falls into the wrong

hands. The drug is so risky it can only be marketed alongside a security system

that guards against recreational — or criminal — use. Why the WLF wants to make

this a common and accepted industry practice is anyone’s guess.

Sent via BlackBerry by AT & T

[Guest guest]

http://m.bnet.com/blog/drug-business/this-drug-rep-says-he-has-a-right-to-sell-a\

-date-rape-drug-as-a-diet-drink/6643?tag=content;drawer-container

A Jazz Pharmaceuticals (JAZZ) drug sales rep convicted for illegally promoting

the date-rape drug GHB as a weight-loss product has appealed his sentence on the

grounds that he had a First Amendment free speech right to speak the “truth”

about the drug.

If the federal appeals court rules in Alfred Caronia’s favor, it would virtually

decriminalize the promotion of unapproved, often dangerous, “off-label” uses of

pharmaceuticals. Previously, courts have rejected this specific argument, but

the federal judiciary is becoming increasingly sympathetic to wrongdoing by drug

companies in other cases.

The Caronia case shows exactly why there are good reasons off-label promotion

should remain illegal: Orphan Medical, the company Jazz acquired in 2005, paid

Dr. Gleason tens of thousands of dollars to travel the country giving

talks to other physicians about the miracle of Xyrem, the brand name under which

Jazz sells GHB. Xyrem is only approved to treat excessive daytime sleepiness in

patients with narcolepsy. Yet Gleason told doctors that Xyrem — a solution that

you drink — was also good for chronic pain, weight loss, depression, bipolar

disorders, fibromylagia, insomnia and Parkinson’s disease. According to the

indictment filed against Gleason and the Jazz drug rep who handled him, Caronia,

the pair also engaged in “deceptive and misleading behavior” by telling doctors

that:

GHB was not a date rape drug

GHB was never banned by the FDA

The FDA regarded Xyrem as a miracle treatment for narcolepsy

A patient could safely overdose on Xyrem without harmful effect

Table salt was more dangerous than Xyrem

Xyrem was safe for very young children

Gleason pled guilty. Caronia was found guilty by a jury. The case should be

closed but it’s being made into a cause celebre by the Washington Legal

Foundation, a right-wing think tank that believes drug companies have the right

to say whatever they want regardless of the consequences as long as they can

also claim they are speaking the “truth.” The WLF frequently acts as Big

Pharma’s litigation stalking horse. Its amicus brief to the appeals court is a

dense thicket of First Amendment law that doesn’t mention what Caronia actually

did.

Worse, WLF’s chief counsel, Samp, has taken advantage of Forbes‘ newly

lax standards for expert bloggers to write about the case under that magazine’s

brand in a manner that suggests the only issue at stake is the free speech

rights of drug company employees. The blog does not specifically state that Samp

is writing about his own case and a client with whom he sympathizes:

FDA apparently is beginning to recognize that First Amendment challenges to its

authority are being taken seriously by the federal courts.

That’s misleading because the last time the FDA said or did anything about

Xyrem, it rejected the drug for use as a treatment for fibromyalgia — one of the

off-label uses promoted by Caronia and Gleason. In fact, the Jazz or the FDA

believed that Xyrem had any use for conditions such as depression or being too

fat, it would be approved for those purposes.

Both Caronia and Gleason received one year probation for their crimes. That

seems generous considering how dangerous Xyrem is when it falls into the wrong

hands. The drug is so risky it can only be marketed alongside a security system

that guards against recreational — or criminal — use. Why the WLF wants to make

this a common and accepted industry practice is anyone’s guess.

Sent via BlackBerry by AT & T