Dr. Dunner The Friendly Ghostwriter

[Guest guest]

Dr. Dunner The Friendly Ghostwriter

http://www.eatthestate.org/06-19/UWsFriendlyCorporate.htm

http://www.drugawareness.org/Archives/2ndQtr_2002/record0021.html

It's worth noting the attempt by the prestigious medical journals to

implement new editorial guidelines to eliminate conflicts of

interest between medical academics and their pharmaceutical industry

sponsors went nowhere. These journals simply could not find and

medical academics without ties to the pharmaceutical industry.

Dr. Dunner of the University of Washington's Department of

Psychiatry admitted he " ghostwrote " an article that appeared in the

March 1995 issue of the journal European Neuropsychopharmacology

(EN) on behalf of pharmaceutical manufacturer Kline-Beecham

(which has since merged with GlaxoWellome to become Glaxo--

Kline, or GSK).

Dunner had purportedly analyzed the data of clinical studies

involving GSK's antidepressant and anti-anxiety drug Paxil and

concluded that it is less likely to lead to suicidal thoughts than

the older antidepressant imipramine and placebo (sugar pill). Dunner

never looked at any of the data but he was still listed as

an " author " of the article.

Meanwhile, Dr. Healy of the University of Wales Department of

Psychological Medicine presented a different analysis of this same

data during the Paxil trial last year. The family of Wyoming

resident Schell, 60, sued GSK in federal court after he shot

his wife, daughter, granddaughter and then himself to death in 1998

after two days on Paxil. Healy testified on behalf of the

plaintiffs. He argued GSK's internal records demonstrated that there

is a substantially increased suicide risk for patients put on Paxil.

The jury agreed with the plaintiff's position that Paxil was

primarily responsible for Schell's actions and awarded them $6.4

million in June of last year. The judge in the case rejected GSK's

challenge of Healy's testimony and sent them packing to a federal

appeals court in Denver in August. A suicide warning has since been

put on the label for the drug, not here in the United States, but in

Britain, where it is known as Seroxat.

Where did Dunner's stunning admission of having ghostwritten such an

important article appear? In either of the local dailies the Seattle

Times or Post-Intelligencer? No, not even close. A Seattle resident

would have to purchase a ticket on the next British Airways flight

from SeaTac to London to meet the author of the article Dunner was

quoted in: Boseley, health editor of the Guardian. Boseley's

February 7 article confirmed what I have suspected all along about

Dunner: He has little or nothing to do with the actual research and

writing behind many of the articles where his name, D.L. Dunner,

appears.

The current situation in peer-reviewed publication in academic and

clinical medical research is starting to resemble the Church's

control over publication of anything in, say, 1300. The

pharmaceutical industry funds most of the research into the crucial

Phase III clinical trials that lead to FDA approval for marketing

drugs (the truth is most of the cost of bringing a drug onto the

market is put up by tax payers). This gives the drug companies an

enormous amount of influence over study design and, most crucially,

they typically retain control over study data as proprietary

information. The end result is that it's difficult to find a

published article in peer reviewed medical journals dealing with

clinical drug studies that weren't supported by funding from the

drug's manufacturer. Most medical journals are now dependent on

pharmaceutical industry advertising to stay in business. This didn't

stop 13 prestigious journals, including the Journal of the American

Medical Association, New England Journal of Medicine and Britain's

Lancet, from publishing an editorial in September of last year

condemning the conditions put on researchers by the drug companies

as, " draconian for self-respecting scientists, but many have

accepted them because they know if they do not, the sponsor will

find someone who will. " The aim of the journals was to implement

editorial policies to authenticate authorship of articles.

" The pharmaceutical companies usually retain the right to withhold

the information their researchers find that they don't want the

public to see, " said Hoeller, community college instructor in

psychology in Seattle and editor of Review of Existential Psychiatry

and Psychology (who also brought the Boseley article to the author's

attention). " These kinds of contractual stipulations also provide

researchers with incentives to find the kind of results the drug

companies are looking for in the studies they fund. "

" It would be a simple matter to say that the data is inherently

unscientific while it remains proprietary, " said Healy. " There

is no other branch of science in which the raw data remains

inaccessible to investigators generally and indeed essentially to

the public. " We can all see what happened when the clinical data in

the Paxil trials became a scientific matter in a court case last

year. This tells us that there may be something to what many critics

of the marketing of psychiatric drugs during the '90s suspected all

along: The public has been fed a self-serving party line about the

efficacy and safety of Paxil, Prozac, Zoloft, and all of the other

newer antidepressant drugs.

Actually Dunner is anything but friendly and approachable on the

topics being reviewed in this article. Dunner won't talk to me about

what he knows about the side effects of the newer antidepressant

drugs and his conflicts of interest with the pharmaceutical

industry. I don't mind Healy's willingness to discuss these matters

with me. It's just that I help pay Dunner's salary and help fund his

department every time I pay Washington state's regressive sales tax,

not Healy's. None of this is a problem in the area of financial

conflict of interest though, as I have recently received copies of

Dunner's honoraria and conflict of interest records from the UW.

Here is a brief summary. Since July of 1997 and up until the end of

last year, Dunner made at least 80 requests for outside professional

work for compensation including 33 lectures sponsored by various

pharmaceutical companies, 14 for various universities and 11 on

behalf of various professional societies and other organizations. No

exact dollar amount is ever given on any of the records I have

obtained. He also spends at least a few days every year as

a " reviewer " for various peer-reviewed academic journals.

Dunner's record also includes eight statements of significant

financial interest. The most significant with regard to the Paxil

clinical trial data is a disclosure he made in 1998. The disclosure

was made regarding an application for a clinical trial dealing with

Paxil in which Dunner would serve as an investigator at his Center

for Anxiety and Depression. His Confidential Statement to the Vice

Provost for Research states, " My involvement with KlineBeecham

(the pre-Glaxo merger owner of Paxil) involves being a member of the

international advisory board related to paroxetine (Paxil). " In

other words, Dunner's name appeared in the EN article not as an

independent scientist but most likely as a part-time employee of the

manufacturer of Paxil. This conflict of interest is not mentioned in

the EN article.

Here is Dunner in his own word's in Boseley's Guardian article: " I

don't know who saw it (the Paxil clinical trial data). I did not. My

role in the paper was that the data were presented to us and we

analyzed it and wrote it up and wrote references. " Dunner's co-

author Stuart Montgomery, then of St. 's hospital medical school

in London, declined comment for the Guardian article. His other co-

author is Geoff Dunbar, a company employee (Dunbar's status as a

Kline employee was mention in the EN article).

Healy figures about half of all articles appearing in medical

journals today are ghostwritten jobs by pharmaceutical companies.

What this tells us is that we should regard much of what we read in

the published medical literature with a level of suspicion similar

to that of a citizen of the former Soviet Union reading Pravda. In

other words, take with a grain of salt any published article

stating " studies show that drug X is a safer and more effective

treatment than drug Y and placebo. "

The lack of candor most of the psychiatric profession and the

pharmaceutical industry has about these heavily marketed drugs has

potentially deadly consequences for the patients taking them.

According to Healy, " The evidence from across the board from all the

companies producing SSRI's (i.e. Prozac, Zoloft, Paxil, et al.) is

that their drugs can make 1 in 20 of us agitated to the extent that

we drop out of trials. " Healy figures that at least 250,000 people

worldwide have attempted suicide because of Prozac alone and 25,000

have succeeded. That sounds like a huge number but if you put

50,000,000 people on the drug, at least 2,500,000 will become

extremely agitated. If ten percent of that population attempts

suicide because of the extreme agitation, that gives you 250,000. If

ten percent of that population succeeds in carrying out their

suicide attempt, you end up with 25,000 dead bodies. Put another 100

million people on Zoloft (comedian Phil Hartman's wife Brynn),

Paxil, Luvox ( at Columbine) and the other more potent

newer antidepressants and you have might have another 50,000 dead

bodies.

" The fact that (pharmaceutical) companies have chose to market them

as antidepressants rather than agents of agitation is a business

decision rather than a scientific matter, " said Healy. Yes, business

has been great for the companies manufacturer these " antidepressant "

drugs. The sales of these drugs is now a $10 billion-per-year

industry. However, the outcomes for the patients put on these drugs

have not necessarily been all that great. The four dead members of

the Schell family are testimony to this fact. GSK's line in the

Paxil trial that their drug didn't have enough time to " help "

Schell follows no coherent logic. What GSK is saying is that Schell

needed to stay on the drug in his agitated state and his dose

possibly needed to be increased, a common occurrence in psychiatric

practice. Increase the patient's dose and you get an even more

agitated individual. You still end up with the deaths of three

generations of Schell's in Gillette, Wyoming on February 13, 1998

with Paxil as the suspected culprit, no matter what kind of semantic

games GSK wishes to engage in with this case.

How much longer is Dunner going to remain silent about the

record of harm these " antidepressant " drugs have caused? How many

articles in Dunner's publication record were ghostwritten? How much

longer are the Times and P-I going to quote Dunner as an unbiased

expert on mental health issues?

[Guest guest]

Dr. Dunner The Friendly Ghostwriter

http://www.eatthestate.org/06-19/UWsFriendlyCorporate.htm

http://www.drugawareness.org/Archives/2ndQtr_2002/record0021.html

It's worth noting the attempt by the prestigious medical journals to

implement new editorial guidelines to eliminate conflicts of

interest between medical academics and their pharmaceutical industry

sponsors went nowhere. These journals simply could not find and

medical academics without ties to the pharmaceutical industry.

Dr. Dunner of the University of Washington's Department of

Psychiatry admitted he " ghostwrote " an article that appeared in the

March 1995 issue of the journal European Neuropsychopharmacology

(EN) on behalf of pharmaceutical manufacturer Kline-Beecham

(which has since merged with GlaxoWellome to become Glaxo--

Kline, or GSK).

Dunner had purportedly analyzed the data of clinical studies

involving GSK's antidepressant and anti-anxiety drug Paxil and

concluded that it is less likely to lead to suicidal thoughts than

the older antidepressant imipramine and placebo (sugar pill). Dunner

never looked at any of the data but he was still listed as

an " author " of the article.

Meanwhile, Dr. Healy of the University of Wales Department of

Psychological Medicine presented a different analysis of this same

data during the Paxil trial last year. The family of Wyoming

resident Schell, 60, sued GSK in federal court after he shot

his wife, daughter, granddaughter and then himself to death in 1998

after two days on Paxil. Healy testified on behalf of the

plaintiffs. He argued GSK's internal records demonstrated that there

is a substantially increased suicide risk for patients put on Paxil.

The jury agreed with the plaintiff's position that Paxil was

primarily responsible for Schell's actions and awarded them $6.4

million in June of last year. The judge in the case rejected GSK's

challenge of Healy's testimony and sent them packing to a federal

appeals court in Denver in August. A suicide warning has since been

put on the label for the drug, not here in the United States, but in

Britain, where it is known as Seroxat.

Where did Dunner's stunning admission of having ghostwritten such an

important article appear? In either of the local dailies the Seattle

Times or Post-Intelligencer? No, not even close. A Seattle resident

would have to purchase a ticket on the next British Airways flight

from SeaTac to London to meet the author of the article Dunner was

quoted in: Boseley, health editor of the Guardian. Boseley's

February 7 article confirmed what I have suspected all along about

Dunner: He has little or nothing to do with the actual research and

writing behind many of the articles where his name, D.L. Dunner,

appears.

The current situation in peer-reviewed publication in academic and

clinical medical research is starting to resemble the Church's

control over publication of anything in, say, 1300. The

pharmaceutical industry funds most of the research into the crucial

Phase III clinical trials that lead to FDA approval for marketing

drugs (the truth is most of the cost of bringing a drug onto the

market is put up by tax payers). This gives the drug companies an

enormous amount of influence over study design and, most crucially,

they typically retain control over study data as proprietary

information. The end result is that it's difficult to find a

published article in peer reviewed medical journals dealing with

clinical drug studies that weren't supported by funding from the

drug's manufacturer. Most medical journals are now dependent on

pharmaceutical industry advertising to stay in business. This didn't

stop 13 prestigious journals, including the Journal of the American

Medical Association, New England Journal of Medicine and Britain's

Lancet, from publishing an editorial in September of last year

condemning the conditions put on researchers by the drug companies

as, " draconian for self-respecting scientists, but many have

accepted them because they know if they do not, the sponsor will

find someone who will. " The aim of the journals was to implement

editorial policies to authenticate authorship of articles.

" The pharmaceutical companies usually retain the right to withhold

the information their researchers find that they don't want the

public to see, " said Hoeller, community college instructor in

psychology in Seattle and editor of Review of Existential Psychiatry

and Psychology (who also brought the Boseley article to the author's

attention). " These kinds of contractual stipulations also provide

researchers with incentives to find the kind of results the drug

companies are looking for in the studies they fund. "

" It would be a simple matter to say that the data is inherently

unscientific while it remains proprietary, " said Healy. " There

is no other branch of science in which the raw data remains

inaccessible to investigators generally and indeed essentially to

the public. " We can all see what happened when the clinical data in

the Paxil trials became a scientific matter in a court case last

year. This tells us that there may be something to what many critics

of the marketing of psychiatric drugs during the '90s suspected all

along: The public has been fed a self-serving party line about the

efficacy and safety of Paxil, Prozac, Zoloft, and all of the other

newer antidepressant drugs.

Actually Dunner is anything but friendly and approachable on the

topics being reviewed in this article. Dunner won't talk to me about

what he knows about the side effects of the newer antidepressant

drugs and his conflicts of interest with the pharmaceutical

industry. I don't mind Healy's willingness to discuss these matters

with me. It's just that I help pay Dunner's salary and help fund his

department every time I pay Washington state's regressive sales tax,

not Healy's. None of this is a problem in the area of financial

conflict of interest though, as I have recently received copies of

Dunner's honoraria and conflict of interest records from the UW.

Here is a brief summary. Since July of 1997 and up until the end of

last year, Dunner made at least 80 requests for outside professional

work for compensation including 33 lectures sponsored by various

pharmaceutical companies, 14 for various universities and 11 on

behalf of various professional societies and other organizations. No

exact dollar amount is ever given on any of the records I have

obtained. He also spends at least a few days every year as

a " reviewer " for various peer-reviewed academic journals.

Dunner's record also includes eight statements of significant

financial interest. The most significant with regard to the Paxil

clinical trial data is a disclosure he made in 1998. The disclosure

was made regarding an application for a clinical trial dealing with

Paxil in which Dunner would serve as an investigator at his Center

for Anxiety and Depression. His Confidential Statement to the Vice

Provost for Research states, " My involvement with KlineBeecham

(the pre-Glaxo merger owner of Paxil) involves being a member of the

international advisory board related to paroxetine (Paxil). " In

other words, Dunner's name appeared in the EN article not as an

independent scientist but most likely as a part-time employee of the

manufacturer of Paxil. This conflict of interest is not mentioned in

the EN article.

Here is Dunner in his own word's in Boseley's Guardian article: " I

don't know who saw it (the Paxil clinical trial data). I did not. My

role in the paper was that the data were presented to us and we

analyzed it and wrote it up and wrote references. " Dunner's co-

author Stuart Montgomery, then of St. 's hospital medical school

in London, declined comment for the Guardian article. His other co-

author is Geoff Dunbar, a company employee (Dunbar's status as a

Kline employee was mention in the EN article).

Healy figures about half of all articles appearing in medical

journals today are ghostwritten jobs by pharmaceutical companies.

What this tells us is that we should regard much of what we read in

the published medical literature with a level of suspicion similar

to that of a citizen of the former Soviet Union reading Pravda. In

other words, take with a grain of salt any published article

stating " studies show that drug X is a safer and more effective

treatment than drug Y and placebo. "

The lack of candor most of the psychiatric profession and the

pharmaceutical industry has about these heavily marketed drugs has

potentially deadly consequences for the patients taking them.

According to Healy, " The evidence from across the board from all the

companies producing SSRI's (i.e. Prozac, Zoloft, Paxil, et al.) is

that their drugs can make 1 in 20 of us agitated to the extent that

we drop out of trials. " Healy figures that at least 250,000 people

worldwide have attempted suicide because of Prozac alone and 25,000

have succeeded. That sounds like a huge number but if you put

50,000,000 people on the drug, at least 2,500,000 will become

extremely agitated. If ten percent of that population attempts

suicide because of the extreme agitation, that gives you 250,000. If

ten percent of that population succeeds in carrying out their

suicide attempt, you end up with 25,000 dead bodies. Put another 100

million people on Zoloft (comedian Phil Hartman's wife Brynn),

Paxil, Luvox ( at Columbine) and the other more potent

newer antidepressants and you have might have another 50,000 dead

bodies.

" The fact that (pharmaceutical) companies have chose to market them

as antidepressants rather than agents of agitation is a business

decision rather than a scientific matter, " said Healy. Yes, business

has been great for the companies manufacturer these " antidepressant "

drugs. The sales of these drugs is now a $10 billion-per-year

industry. However, the outcomes for the patients put on these drugs

have not necessarily been all that great. The four dead members of

the Schell family are testimony to this fact. GSK's line in the

Paxil trial that their drug didn't have enough time to " help "

Schell follows no coherent logic. What GSK is saying is that Schell

needed to stay on the drug in his agitated state and his dose

possibly needed to be increased, a common occurrence in psychiatric

practice. Increase the patient's dose and you get an even more

agitated individual. You still end up with the deaths of three

generations of Schell's in Gillette, Wyoming on February 13, 1998

with Paxil as the suspected culprit, no matter what kind of semantic

games GSK wishes to engage in with this case.

How much longer is Dunner going to remain silent about the

record of harm these " antidepressant " drugs have caused? How many

articles in Dunner's publication record were ghostwritten? How much

longer are the Times and P-I going to quote Dunner as an unbiased

expert on mental health issues?