Healy ....on Dunner Ghostwriting

[Guest guest]

DH: Ghostwriting is at the heart of the process. I am due to lecture

today (October 28) at Grand Rounds in the Neuropsychiatric Institute

in UCLA. This will be webcast. At the heart of this talk will be

just this issue with some of the examples outlined in the book.

Ghostwriting though is not the biggest problem. Often these writers

(at the firms hired by pharmaceutical companies to write peer-

reviewed articles for academic journals) will write better than most

academics and they get results out quicker and will often be more

honest. The key problem is lack of access to the data from these

trials and against the background of this lack of data, the

questions of ghostwriting, conflict of interest, and consultancies

assume the importance they have. I think though journals who are

worried about how to make sure authors are real authors are missing

the key point. In the article you refer to the key point is not

whether Dunner was an author in the usual sense of the word

but the fact that the data in that article are just plain wrong.

They give the impression there is no difference between placebo

suicidal act rates and Paxil suicidal act rates, when in fact the

raw data shows a possible up to 8-fold higher rate of suicidal acts

on Paxil

> >

> > Happy New Year everyone

> > With the New Year comes more new spin from the drug pushers.

> >

> >

>

http://www.forbes.com/lifestyle/health/feeds/hscout/2006/01/01/hscout

> 529949.html

> > Health

> > Antidepressants Work and Don't Boost Suicide Risk: Studies

> >

> >

> > SUNDAY, Jan. 1 (HealthDay News) -- Contrary to what has been

> feared,

> > the antidepressants known as serotonin reuptake inhibitors

(SSRIs)

> are

> > initially effective in as many as one-third of depressed

patients

> and

> > don't appear to increase the risk of suicide, two new studies

> claim.

> >

> > The reports, both of which were funded by the National Institute

of

> > Mental Health, appear in the January issue of the American

Journal

> of

> > Psychiatry.

> >

> > The suicide findings seem to challenge a 2004 advisory by the

U.S.

> > Food and Drug Administration that warned that suicidal behavior

may

> > increase after treatment with SSRIs. However, the study did find

> that

> > suicide attempts were higher among teens than adults, a finding

> borne

> > out by other research.

> >

> > The first report is based on early data from the Sequenced

> Treatment

> > Alternatives to Relieve Depression (STAR*D) trial, the largest

> study

> > of its kind. This research looked at the benefits of

> antidepressants

> > in " real world " settings.

> >

> > " About a third of the patients achieved remission, " said lead

> > researcher Dr. Madhukar Trivedi, director of the Mood Disorders

> > Research Program and Clinic at the University of Texas

Southwestern

> > Medical Center, in Dallas. " An additional 10 to 15 percent

> achieved a

> > response. "

> >

> > The object of the study was to provide physicians with

guidelines

> for

> > treating depression, Trivedi said. " The goal is to have patients

> > provided with an adequate dose of medication for an adequate

> time, " he

> > explained. " Treatment would be tailored for each individual

> patient to

> > get the most benefit from treatment. "

> >

> > For the study, researchers looked at the results of prescribing

the

> > SSRI Celexa to 2,876 patients with major depression. These

patients

> > also had other physical and psychological problems. The

researchers

> > found that about a third of the patients had their depression

cured

> > during the first 12 weeks of treatment.

> >

> > In addition, another 10 percent to 15 percent of the patients

> showed a

> > response to the medication, or reduction of at least half their

> > symptoms. For patients who did not improve, later phases of the

> trial

> > will use other medications or combinations of medications to see

> what

> > might help those who did not benefit from the drug used in the

> first

> > phase of the trial.

> >

> > " These antidepressants in routine clinical care produce outcomes

> > comparable with what is seen in research settings, " Trivedi said.

> > " These treatments do work in routine clinical care. There also

has

> to

> > be careful monitoring of side effects. In addition, you have to

> > monitor dose and duration of the treatment, based on the

patient's

> > progression. "

> >

> > One expert thinks this study will eventually provide guideposts

for

> > treating depression that physicians can follow.

> >

> > " This study, when it is all finally published, will give us a

very

> > good idea of how to treat treatment-resistant depression, and

what

> the

> > next step is after the SSRI fails, " said Dr. L. Dunner,

> director

> > of the University of Washington's Center for Anxiety and

> Depression.

> >

> > In the second study, researchers found the risk of suicide

attempts

> > and of successful suicides actually dropped in the weeks

following

> the

> > start of SSRI therapy.

> >

> > " The risk of a serious suicide attempt in people who start taking

> > antidepressant medication is, fortunately, quite low -- less

than

> one

> > in 1,000, " said lead author Dr. Greg Simon, a researcher at the

> Group

> > Health ative, in Seattle. " The risk actually goes down

after

> > people start antidepressant medication. "

> >

> > The study also found no increase in suicide risk with the newer

> > antidepressants, such as SSRIs, Simon added. " If anything, our

data

> > suggests that with the newer antidepressants there is less risk

> than

> > with the older antidepressants, " he said.

> >

> > For the study, Simons's team collected data on 65,103 patients

who

> had

> > prescriptions for antidepressants between 1992 and 2003.

> >

> > The researchers found the number of suicide attempts dropped by

60

> > percent in adults in the first month after starting treatment.

The

> > suicide rate continued to drop in the succeeding five months.

> >

> > Among all the patients, there were 31 suicides in the six months

> after

> > starting antidepressant therapy. That rate did not change from

one

> > month after starting treatment or in subsequent months.

> >

> > However, teens had more suicide attempts than adults. Simon's

group

> > found that in the first six months of antidepressant treatment,

the

> > suicide rate was 314 attempts per 100,000 in teens, vs. 78

attempts

> > per 100,000 in adults. For teens and adults, the rate was

highest

> in

> > the month before treatment and dropped by about 60 percent after

> > treatment began, the researchers found.

> >

> > In its 2004 warning, the FDA said people taking antidepressants

> should

> > be closely monitored because of the risk of suicide.

> >

> > " People should be closely monitored, but not because these drugs

> are

> > especially risky, " Simon said. " The real problem in the

treatment

> of

> > depression is that people start medicine and the medicine has

side

> > effects or the medicine doesn't work right away, and they get

> > discouraged and they drop out. "

> >

> > Dunner agreed that close monitoring is essential when prescribing

> > patients antidepressants. " Monitoring depression is very

> important, "

> > he said. " Often people come in for treatment when they are

> starting to

> > get worse. "

> >

> > Monitoring is needed more for side effects from the drugs than to

> > watch for suicidal behavior, Dunner said. " Suicide is a pretty

rare

> > event, " he said. " It is more important to monitor for side

effects

> and

> > adherence to the medication. "

> >

> > More information

> >

> > The American Academy of Family Physicians can tell you more about

> > antidepressants.

> >

>

[Guest guest]

DH: Ghostwriting is at the heart of the process. I am due to lecture

today (October 28) at Grand Rounds in the Neuropsychiatric Institute

in UCLA. This will be webcast. At the heart of this talk will be

just this issue with some of the examples outlined in the book.

Ghostwriting though is not the biggest problem. Often these writers

(at the firms hired by pharmaceutical companies to write peer-

reviewed articles for academic journals) will write better than most

academics and they get results out quicker and will often be more

honest. The key problem is lack of access to the data from these

trials and against the background of this lack of data, the

questions of ghostwriting, conflict of interest, and consultancies

assume the importance they have. I think though journals who are

worried about how to make sure authors are real authors are missing

the key point. In the article you refer to the key point is not

whether Dunner was an author in the usual sense of the word

but the fact that the data in that article are just plain wrong.

They give the impression there is no difference between placebo

suicidal act rates and Paxil suicidal act rates, when in fact the

raw data shows a possible up to 8-fold higher rate of suicidal acts

on Paxil

> >

> > Happy New Year everyone

> > With the New Year comes more new spin from the drug pushers.

> >

> >

>

http://www.forbes.com/lifestyle/health/feeds/hscout/2006/01/01/hscout

> 529949.html

> > Health

> > Antidepressants Work and Don't Boost Suicide Risk: Studies

> >

> >

> > SUNDAY, Jan. 1 (HealthDay News) -- Contrary to what has been

> feared,

> > the antidepressants known as serotonin reuptake inhibitors

(SSRIs)

> are

> > initially effective in as many as one-third of depressed

patients

> and

> > don't appear to increase the risk of suicide, two new studies

> claim.

> >

> > The reports, both of which were funded by the National Institute

of

> > Mental Health, appear in the January issue of the American

Journal

> of

> > Psychiatry.

> >

> > The suicide findings seem to challenge a 2004 advisory by the

U.S.

> > Food and Drug Administration that warned that suicidal behavior

may

> > increase after treatment with SSRIs. However, the study did find

> that

> > suicide attempts were higher among teens than adults, a finding

> borne

> > out by other research.

> >

> > The first report is based on early data from the Sequenced

> Treatment

> > Alternatives to Relieve Depression (STAR*D) trial, the largest

> study

> > of its kind. This research looked at the benefits of

> antidepressants

> > in " real world " settings.

> >

> > " About a third of the patients achieved remission, " said lead

> > researcher Dr. Madhukar Trivedi, director of the Mood Disorders

> > Research Program and Clinic at the University of Texas

Southwestern

> > Medical Center, in Dallas. " An additional 10 to 15 percent

> achieved a

> > response. "

> >

> > The object of the study was to provide physicians with

guidelines

> for

> > treating depression, Trivedi said. " The goal is to have patients

> > provided with an adequate dose of medication for an adequate

> time, " he

> > explained. " Treatment would be tailored for each individual

> patient to

> > get the most benefit from treatment. "

> >

> > For the study, researchers looked at the results of prescribing

the

> > SSRI Celexa to 2,876 patients with major depression. These

patients

> > also had other physical and psychological problems. The

researchers

> > found that about a third of the patients had their depression

cured

> > during the first 12 weeks of treatment.

> >

> > In addition, another 10 percent to 15 percent of the patients

> showed a

> > response to the medication, or reduction of at least half their

> > symptoms. For patients who did not improve, later phases of the

> trial

> > will use other medications or combinations of medications to see

> what

> > might help those who did not benefit from the drug used in the

> first

> > phase of the trial.

> >

> > " These antidepressants in routine clinical care produce outcomes

> > comparable with what is seen in research settings, " Trivedi said.

> > " These treatments do work in routine clinical care. There also

has

> to

> > be careful monitoring of side effects. In addition, you have to

> > monitor dose and duration of the treatment, based on the

patient's

> > progression. "

> >

> > One expert thinks this study will eventually provide guideposts

for

> > treating depression that physicians can follow.

> >

> > " This study, when it is all finally published, will give us a

very

> > good idea of how to treat treatment-resistant depression, and

what

> the

> > next step is after the SSRI fails, " said Dr. L. Dunner,

> director

> > of the University of Washington's Center for Anxiety and

> Depression.

> >

> > In the second study, researchers found the risk of suicide

attempts

> > and of successful suicides actually dropped in the weeks

following

> the

> > start of SSRI therapy.

> >

> > " The risk of a serious suicide attempt in people who start taking

> > antidepressant medication is, fortunately, quite low -- less

than

> one

> > in 1,000, " said lead author Dr. Greg Simon, a researcher at the

> Group

> > Health ative, in Seattle. " The risk actually goes down

after

> > people start antidepressant medication. "

> >

> > The study also found no increase in suicide risk with the newer

> > antidepressants, such as SSRIs, Simon added. " If anything, our

data

> > suggests that with the newer antidepressants there is less risk

> than

> > with the older antidepressants, " he said.

> >

> > For the study, Simons's team collected data on 65,103 patients

who

> had

> > prescriptions for antidepressants between 1992 and 2003.

> >

> > The researchers found the number of suicide attempts dropped by

60

> > percent in adults in the first month after starting treatment.

The

> > suicide rate continued to drop in the succeeding five months.

> >

> > Among all the patients, there were 31 suicides in the six months

> after

> > starting antidepressant therapy. That rate did not change from

one

> > month after starting treatment or in subsequent months.

> >

> > However, teens had more suicide attempts than adults. Simon's

group

> > found that in the first six months of antidepressant treatment,

the

> > suicide rate was 314 attempts per 100,000 in teens, vs. 78

attempts

> > per 100,000 in adults. For teens and adults, the rate was

highest

> in

> > the month before treatment and dropped by about 60 percent after

> > treatment began, the researchers found.

> >

> > In its 2004 warning, the FDA said people taking antidepressants

> should

> > be closely monitored because of the risk of suicide.

> >

> > " People should be closely monitored, but not because these drugs

> are

> > especially risky, " Simon said. " The real problem in the

treatment

> of

> > depression is that people start medicine and the medicine has

side

> > effects or the medicine doesn't work right away, and they get

> > discouraged and they drop out. "

> >

> > Dunner agreed that close monitoring is essential when prescribing

> > patients antidepressants. " Monitoring depression is very

> important, "

> > he said. " Often people come in for treatment when they are

> starting to

> > get worse. "

> >

> > Monitoring is needed more for side effects from the drugs than to

> > watch for suicidal behavior, Dunner said. " Suicide is a pretty

rare

> > event, " he said. " It is more important to monitor for side

effects

> and

> > adherence to the medication. "

> >

> > More information

> >

> > The American Academy of Family Physicians can tell you more about

> > antidepressants.

> >

>