American DRs are among the biggest liars on the face of the earth. They are constantly prescribing medication that do not work, cover up symptoms, or drive people to suicide. That is in addition to bankrupting America.
The below story tells how they are paid by drug companies to prescribe medications. The ironic thing is Xyrem is a good medication. This guy is being attacked because it works much better than any other sleep medication and they want it to disappear.
Imagine how much DRs are paid to prescribe anti depressants?
http://www.nytimes.com/2006/07/22/business/22drugdoc.html?_r=2
At first, Dr. Peter Gleason thought his arrest was a joke.
Enlarge This Image
Ozier Muhammad/The New York Times
Dr. Peter Gleason, 53, promoted Xyrem for purposes other than those approved by the federal government and now faces charges.
Side Effects
Articles in this series are examining how money from drug and medical device companies can influence the ways doctors conduct business and practice medicine.
In the early afternoon of Monday, March 6, half a dozen men in suits surrounded Dr. Gleason, a Maryland psychiatrist, at a train station on Long Island and handcuffed him.
âI said, âWell, this is a gag,â â Dr. Gleason recalled in a recent interview. âThey said, âNo, this isnât.â â
Dr. Gleason, 53, was taken aback because he was arrested, and later charged, for doing something that has become common among doctors: promoting a drug for purposes other than those approved by the federal government.
But prosecutors say that Dr. Gleason went too far. At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drugâs manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.
The case has put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines. Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drugâs sales, so companies often skirt the rules by sponsoring seminars where doctors are paid to make presentations promoting their drugs, including the âoff labelâ uses.
For doctors, these and other payments they receive for discussing drugs can be very lucrative. Dr. Gleason acknowledges that he received more than $100,000 last year alone from Jazz Pharmaceuticals, which makes Xyrem, the narcolepsy drug he has promoted.
His case could establish limits on what doctors can do to help companies sell their drugs. But any precedent could be complicated by the history of Xyrem, which differs in one important way from other drugs. Because the active ingredient in Xyrem is gamma hydroxybutyrate, or GHB, an illegal street drug with a history of use in date rape and of overdose hazards, Xyrem is listed as a federally controlled substance, with distribution tightly monitored.
Some doctors who have researched Xyrem say that Dr. Gleason, in his enthusiasm for the drug, may have understated its very real risks. Still, at least one former F.D.A. official says that the government appears to be overreaching in going after Dr. Gleason and may chill a common and legitimate form of medical discussion. âThis is a very, very scary development,â said Daniel E. Troy, a partner at Sidley Austin and the former chief counsel of the F.D.A.
Dr. Steven Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, said the case could âhave a chilling effect on physicians, because when we give lectures, we assume that giving an opinion about the use of a drug is not going to get us into legal difficulty.â The F.D.A. and federal lawyers, he said, need to restrict criminal prosecutions to especially egregious cases of off-label promotion.
Continuing to Practice
Dr. Gleason, who is now free on bail and continues to practice medicine, insists that he is not guilty of conspiracy. He says that he was charged only after he refused to help the government build a case against the drugâs maker, Jazz Pharmaceuticals â a sequence of events that court documents seem to support.
Dr. Gleason freely acknowledges that in meetings with other doctors, he advocated Xyrem as a treatment for many conditions, including depression and fibromyalgia, a poorly understood pain disorder.
In a news release about the indictment, an assistant F.B.I. director compared Dr. Gleason to a âcarnival snake-oil salesman.â
But the doctor says that based on his own experience giving Xyrem to patients, he believes everything he said about the drug and that his right to express his views are protected by both F.D.A. rules and the First Amendment.
Some lawyers who have reviewed Dr. Gleasonâs case, but are not representing him, say they agree.
Dr. Gleason has been trapped in the complex rules that cover what doctors and drug manufacturers are allowed to say about prescription drugs, according to Harvey A. Silverglate, a lawyer in Boston who specializes in civil liberties cases.
âWhat they are doing is criminalizing conduct that is not clearly criminal,â said Mr. Silverglate, who is not involved in Dr. Gleasonâs defense.
Neither the F.D.A. nor the United States attorneyâs office in Brooklyn, which indicted Dr. Gleason, would comment on the case. Nor would David Loftus, a public defender who took over the case after Dr. Gleason determined he could not afford a private lawyer. Jazz Pharmaceuticals, which has not been charged, also declined to comment.
F.D.A. rules allow doctors to prescribe federally approved drugs for any purpose, even if it is not indicated on the medicineâs label. But drug companies are tightly constrained in what they can say about their medicines. Companies can promote drugs only for their federally approved purposes â their so-called âon labelâ use.
âOff labelâ promotion by drug companies is illegal, and since 2000 drug makers have paid large fines to settle federal criminal cases over off-label prescriptions.
Pfizer, for example, paid $430 million in 2004 to settle allegations that it had promoted Neurontin, an anti-epilepsy medicine, for pain and bipolar disorder.
The below story tells how they are paid by drug companies to prescribe medications. The ironic thing is Xyrem is a good medication. This guy is being attacked because it works much better than any other sleep medication and they want it to disappear.
Imagine how much DRs are paid to prescribe anti depressants?
http://www.nytimes.com/2006/07/22/business/22drugdoc.html?_r=2
At first, Dr. Peter Gleason thought his arrest was a joke.
Enlarge This Image
Ozier Muhammad/The New York Times
Dr. Peter Gleason, 53, promoted Xyrem for purposes other than those approved by the federal government and now faces charges.
Side Effects
Articles in this series are examining how money from drug and medical device companies can influence the ways doctors conduct business and practice medicine.
In the early afternoon of Monday, March 6, half a dozen men in suits surrounded Dr. Gleason, a Maryland psychiatrist, at a train station on Long Island and handcuffed him.
âI said, âWell, this is a gag,â â Dr. Gleason recalled in a recent interview. âThey said, âNo, this isnât.â â
Dr. Gleason, 53, was taken aback because he was arrested, and later charged, for doing something that has become common among doctors: promoting a drug for purposes other than those approved by the federal government.
But prosecutors say that Dr. Gleason went too far. At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drugâs manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.
The case has put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines. Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drugâs sales, so companies often skirt the rules by sponsoring seminars where doctors are paid to make presentations promoting their drugs, including the âoff labelâ uses.
For doctors, these and other payments they receive for discussing drugs can be very lucrative. Dr. Gleason acknowledges that he received more than $100,000 last year alone from Jazz Pharmaceuticals, which makes Xyrem, the narcolepsy drug he has promoted.
His case could establish limits on what doctors can do to help companies sell their drugs. But any precedent could be complicated by the history of Xyrem, which differs in one important way from other drugs. Because the active ingredient in Xyrem is gamma hydroxybutyrate, or GHB, an illegal street drug with a history of use in date rape and of overdose hazards, Xyrem is listed as a federally controlled substance, with distribution tightly monitored.
Some doctors who have researched Xyrem say that Dr. Gleason, in his enthusiasm for the drug, may have understated its very real risks. Still, at least one former F.D.A. official says that the government appears to be overreaching in going after Dr. Gleason and may chill a common and legitimate form of medical discussion. âThis is a very, very scary development,â said Daniel E. Troy, a partner at Sidley Austin and the former chief counsel of the F.D.A.
Dr. Steven Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, said the case could âhave a chilling effect on physicians, because when we give lectures, we assume that giving an opinion about the use of a drug is not going to get us into legal difficulty.â The F.D.A. and federal lawyers, he said, need to restrict criminal prosecutions to especially egregious cases of off-label promotion.
Continuing to Practice
Dr. Gleason, who is now free on bail and continues to practice medicine, insists that he is not guilty of conspiracy. He says that he was charged only after he refused to help the government build a case against the drugâs maker, Jazz Pharmaceuticals â a sequence of events that court documents seem to support.
Dr. Gleason freely acknowledges that in meetings with other doctors, he advocated Xyrem as a treatment for many conditions, including depression and fibromyalgia, a poorly understood pain disorder.
In a news release about the indictment, an assistant F.B.I. director compared Dr. Gleason to a âcarnival snake-oil salesman.â
But the doctor says that based on his own experience giving Xyrem to patients, he believes everything he said about the drug and that his right to express his views are protected by both F.D.A. rules and the First Amendment.
Some lawyers who have reviewed Dr. Gleasonâs case, but are not representing him, say they agree.
Dr. Gleason has been trapped in the complex rules that cover what doctors and drug manufacturers are allowed to say about prescription drugs, according to Harvey A. Silverglate, a lawyer in Boston who specializes in civil liberties cases.
âWhat they are doing is criminalizing conduct that is not clearly criminal,â said Mr. Silverglate, who is not involved in Dr. Gleasonâs defense.
Neither the F.D.A. nor the United States attorneyâs office in Brooklyn, which indicted Dr. Gleason, would comment on the case. Nor would David Loftus, a public defender who took over the case after Dr. Gleason determined he could not afford a private lawyer. Jazz Pharmaceuticals, which has not been charged, also declined to comment.
F.D.A. rules allow doctors to prescribe federally approved drugs for any purpose, even if it is not indicated on the medicineâs label. But drug companies are tightly constrained in what they can say about their medicines. Companies can promote drugs only for their federally approved purposes â their so-called âon labelâ use.
âOff labelâ promotion by drug companies is illegal, and since 2000 drug makers have paid large fines to settle federal criminal cases over off-label prescriptions.
Pfizer, for example, paid $430 million in 2004 to settle allegations that it had promoted Neurontin, an anti-epilepsy medicine, for pain and bipolar disorder.
