Fwd: [SSRI-Research] Let Them Eat Prozac: An Interview With David Healy

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[sSRI-Research] Let Them Eat Prozac: An Interview With David Healy

 

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Let Them Eat Prozac: An Interview With David Healy

 

The past fifteen years has witnessed a major comeback for the marketing of

new psychiatric drugs. There is almost no end to the therapeutic claims that

have been made regarding these drugs, with the most popular among them,

especially Prozac, obtaining a cult like status similar to that of LSD

before it. A dark side lurks behind the multi-billion advertising campaigns

and doctor endorsements for the newer psychiatric drugs. A dark side which

includes inconvenient facts that have been known all along, such as the fact

that patients who take the newer psychiatric drugs are more likely to kill

themselves than if they hadn't taken the drugs in the first place. Or that

placebo, a.k.a. sugar pills, have performed as well or better than the newer

antidepressant drugs in clinical trials.

 

David Healy's new book Let Them Eat Prozac attempts to put into the public

domain these and many other inconvenient facts about the marketing of the

Selective Serotonin Reuptake Inhibitor (SSRI) class of antidepressant drugs,

namely, Paxil, Prozac, Zoloft, et al. Drawing from his career as both an

academic and practicing psychiatrist, and as an expert witness in lawsuits

against the pharmaceutical industry, Let Them Eat Prozac traces Healy's

development from a pharmaceutical industry consultant to independent critic

of the industry, culminating in the withdrawal of a job offer from the

University of Toronto and subsequent breech of contract lawsuit after

delivering a public lecture. Let Them Eat Prozac should be of interest to

anybody wanting to learn more about a history most people in the United

States and beyond know little or nothing about. It should also be of special

to interest to anybody planning to attend the upcoming February 2 Food and

Drug Administration (FDA) hearing on prescribing the newer antidepressant

drugs to children.

 

Let Them Eat Prozac is currently only available through the Canadian

publishing concern Lorimer. However, it can ordered by residents of the

United States (I did so the day before I wrote this article and was charged

$27.66 U.S. dollars for the book, plus shipping and handling. If you don't

want to wait for the American edition of the book to come out this Spring,

then you can order it from Lorimer by calling toll free 1-800-565-1975,

Monday - Friday, 8am - 4pm Eastern time). In the interest of informing an

American audience of the book before the convening of the upcoming FDA

hearing, I conducted a brief interview with the author via e-mail. -Rick

 

Rick Giombetti: The title of this book quickly caught my attention. You're

writing career, much of it focusing on recording the history of

psychopharmacology, has revolved around the ivory tower of academia and

peer-reviewed academic publications. The title of your new book is likely to

conjure up images of an angry populace upset with what they've been getting

fed by psychiatry and the pharmaceutical industry for the past fifteen

years. An angry populace demanding accountability for the marketing of the

newer generation of psychiatric drugs, like at the upcoming February 2 FDA

hearing on prescribing antidrepressant drugs to children. How did you come

up with the title for this book?

 

Davidy Healy: When talking to a colleague one afternoon about the outline of

the book, my then 14 year old son was on his way through the room and he

said " you know what you should call that - let them eat prozac " . Publishers

and editors uniformly hate the title but they haven't been able come up with

a better one.

 

RG: The publication of the book appears to be a quite Canadian event, but it

clearly contains information that is of interest to anybody living in a

society touched by the aggressive marketing of the newer antidepressant

drugs. It appears the seminal event that led to the publication of this book

was your firing from a professorship at the University of Toronto and the

subsequent breech of contract lawsuit. What were the primary purposes for

publishing this book and why did Lorimer become the publisher?

 

DH: The book was essentially written before I got fired. So my firing was

added onto rather than the center of or reason for the book.

 

I approached a number of university publishers who said it would be a better

trade book and a number of trade publishers who said it would be a better

university press book and they all said, " By the way, no one is interested

in a book on the pharmaceutical industry. "

 

The book ended up with Lorimer who publishes for the Canadian Association

for University Teachers - so this is a CAUT book. Why? Well first of all it

is a privilege to be linked to CAUT who did so much for me. But also I think

the Canadians more than either the Americans, the British or other Europeans

have got a grip on the corporatization of healthcare and especially the

issue of how this impacts on academic freedom or the traditional role of the

universities and if you want to make a difference on these issues this is

the coalition to link in to it seems to me.

 

But the book is also now due out in Spring in the US from New York

University Press who have done a great job on editing it into better shape

and making it generally more user friendly.

 

One of the things to note is that the book comes with a website and the hope

was to make the whole episode into a resource for social scientists,

bioethicists and anyone interested in healthcare and corporate governance

issues. To this end CAUT, who host the website healyprozac.com, are open to

having other accounts of academic freedom cases posted on this site but also

contrary views on how this data stacks up provided the view is not simply

polemical. The site makes available a huge amount of material which does

offer the opportunity for people to make up their own mind and any relevant

material could be posted. The criterion for access is a posting that

contains new material that can contribute to genuine debate in these areas.

 

RG: The subject of ghost writing is dealt with in your book. This is a

subject that has touched us in the Seattle area where I live, as Dr. David

Dunner of the University of Washington admitted to the Guardian last year

that he " ghost wrote " (i.e. he had nothing to do with an article he

" authored " ) an article for the March 1995 issue of European

Neuropsychopharmacology. From reading the descriptions of the publication

process in the medical academic journals in the outline for the book on the

Internet site, it sounds more like a public relations operation on behalf of

pharmaceuticals and their products than a scientific undertaking. Is this a

fair characterization of the current state of medical academic publishing?

 

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 David

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.

 

RG: Last year another Seattle area researcher Dr. Arif Kahn of the Northwest

Center for Clinical Research colated the clinical trail data in the public

domain for all the psychiatric drugs approved by the FDA for marketing from

1985 - 2000. Kahn found disturbingly high suicide rates among the 71,604

subjects who took the drugs in the clinical trials. Among the aggressively

marketed newer antidepressants and neuroleptics the suicide rates almost

matched the overall annual U.S. death rate. Dr. Kahn appears to be doing

something you've been doing for years as an expert witness in lawsuits

against pharmaceutical companies for the marketing of their newer

antidepressants. How was this important, and apparently difficult to find,

clinical trial data unearthed by way of discovery in court?

 

DH: What Dr Khan and I have been doing is quite different. He accesses FDA

reviews and not the raw data. He does not appear to have seen the raw data

lying behind the tables prepared by the companies for the FDA. Had he had

access to the raw data the figures he presented would have been far more

alarming.

 

RG: I noticed at the Internet site for the book that not even British

government officials can observe the clinical trial data pharmaceutical

companies used to make scientific claims about their aggressively marketed

psychiatric drugs. Here in the U.S. we have a Freedom Of Information Act and

discovery in lawsuits, but these instruments are too little too late for the

people who have taken the newer antidepressants since they've been

introduced to the market. It seems like the more clinical trial data

pertaining to the newer psychiatric drugs gets put into the public domain,

the worse the pharmaceutical companies and their drugs look. Do the events

of the recent past with the newer generation of antidepressant drugs demand

democratic transparency in the regulatory approval process for new drugs? By

democratic transparency I mean putting all the clinical trial data into the

public domain for comment before a drug can be approved for marketing.

DH: FOIA will only get you FDA reviews in the main. From this you can get

the names of individual trial protocols and you might be able to get

summaries of these but you can't get the raw data. In Britain we have even

less access, and any developments there have been in the UK are down to the

efforts of the media and two women in particularly, Shelley Jofre and Sarah

Boseley, who while looking at the scientific publications have said " wait a

minute, this doesn't add up " .

 

In the absence of access to data generated by people like the readers of

this website taking risks with their lives and health with new drugs, only

to have the companies bury the inconvenient findings, there is one other way

forward. Groups like the American Psychiatric Association or the Royal

College of Psychiatrists, who increasingly feature presentations of " data "

from these trials at their annual meetings, could make it clear that they do

not regard selected datasets without rights of access to the entire set as

scientific data. I think there has been a shameful professional failing

here.

 

RG: Are there any antidepressants you are currently not prescribing? If

there are any you are no longer prescribing could you explain why?

 

DH: I have never prescribed venlafaxine (a.k.a Effexor). The data always

smelt fishy to me and the marketing of this drug was even less satisfactory

than that of the others - this is not to say there aren't some perfectly

decent people in Wyeth, our local representative is one of the most decent

we have.

 

The emergence of data in recent years especially on dependence and

withdrawal from Paxil has meant that I no longer use this, where once I used

it or recommended it a lot. I have many people who are suffering very

severely with this withdrawal syndrome, which in some cases looks like it

will mean that people cannot ever stop treatment. I do not want the SSRIs

removed from the market, I have only ever wanted them to come with

appropriate warnings, but if you had to make an exception to that it might

be Paxil on the basis that we have 5 other SSRIs to choose from, losing one

would not be a disaster.

 

I think its worth adding here that I can't see how anyone can prescribe

Zyprexa. The basis for doing so on an informed basis just isn't there, given

that Zyprexa manufacturer Eli Lilly refuses to put into the public domain

the data on suicidal acts in their clinical trials and it seems that neither

the FDA nor Arif Khan have access to this. Against a background of what

seems to be the highest suicide rate in psychotropic clinical trial history,

the fact that this drug had gone on to become the best-selling psychotropic

agent at the moment I think stands as a good symbol of all the problems in

the field.

 

David Healy is Reader in Psychological Medicine at the University of Wales

College of Medicine and Visiting Professor of Medicine at the University of

Toronto. He received his medical degree from University College Dublin and

was a Clinical Research Associate at the University of Cambridge. Former

Secretary of the British Association for Psychopharmacology, Healy is author

of more than 120 peer reviewed articles and more than a dozen books,

including The Antidepressant Era (Harvard) and The Creation of

Psychopharmacology (Harvard).

 

10.27.2003

 

Failed Suicide Attempts Effective At Treating Depression

 

More good news about depression: You stand a good chance of lifting your

blues if you survive an attempt to do yourself in. The researchers below

note that what is going on here is the placebo effect of beating the odds

and surviving, say, a life threatening fall from a bridge into water. Many

people are uplifted by the new lease on life surviving a suicide attempt

gives them. However, some survivors do relapse as " the team suggests a

decrease in the transient cathartic effect of a suicide attempt " after a

month. So it's time to toss your drugs into the trash can and find a place

to jump. You'll feel a lot better if you survive. -Rick

 

Suicide attempt reduces depressive symptoms

 

Depressed people who attempt suicide appear to experience a greater

improvement in their symptoms in the first week of admission than

nonsuicidal patients with depression, investigators reveal, although this

effect may be restricted to unipolar depression.

 

Following conflicting results on the relief of depression following

attempted suicide, Kaoru Sakamoto and colleagues from Tokyo Women's Medical

University School of Medicine, Japan, examined the impact of attempted

suicide on the course of mood disorders in 80 depressed inpatients. Of

these, 40 had attempted suicide immediately before admission, while the

remainder had not.

 

Comparing the severity of depression at week 1 after admission, the

researchers found that the improvement rate among depressive patients who

had attempted suicide was significantly higher than for those who had not

attempted suicide, at 37.5% and 17.5%, respectively.

 

This difference appeared to occur primarily among patients with unipolar

depression, whereas no significant difference was found between patients

with bipolar depression who had and had not attempted suicide.

 

The researchers note in the Journal of Clinical Psychiatry that of the 15

patients showing postsuicidal improvement of depression, five (33%) relapsed

within one month.

 

While there were no significant predictors for relapse, the team suggests a

decrease in the transient cathartic effect of a suicide attempt.

Alternatively, patients may be discharged earlier and treatment intensity

may decrease as a result of reduced depressive symptomatology.

 

Sakamoto et al conclude that, even if a postsuicidal improvement in

depression is observed, vigilant inpatient and outpatient monitoring is

warranted to prevent a relapse of depression or even a repeat suicide

attempt.

 

The Impact of Attempted Suicide on the Symptoms and Course of Mood Disorders

 

Kaoru Sakamoto, M.D., Ph.D., and Takako Fukunaga, M.D., Ph.D.

 

Background: Case-controlled studies have produced conflicting results on the

relief of depression following attempted suicide. This study examined the

impact of attempted suicide on the symptoms and course of mood disorders.

 

Method: Of 2800 inpatients reviewed retrospectively, 40 depressed patients

who had attempted suicide immediately before admission and 40 depressed but

nonsuicidal control patients satisfied entry criteria for the study. The

overall severity of their depression had been rated by the treating

psychiatrists before the attempted suicide or at admission using the

DSM-III-R (or DSM-IV) severity scale. The severity of depression at 1 week

after admission was evaluated by reviewing medical records. For categorical

analysis, improvement was defined as a reduction of one or more categories

on the DSM-III-R (or DSM-IV) severity scale. We assigned scores of 1-6 to

this scale to enable quantitative comparisons.

 

Results: Both categorical and dimensional analyses demonstrated that

depression was significantly (p < .05) more likely to improve within 1 week

of admission among suicidal unipolar patients than among nonsuicidal

unipolar patients. Logistic regression analyses revealed that a unipolar

course was significantly (p == .023) associated with the improvement of

depression. Of the 15 patients showing postsuicidal improvement of

depression, 5 (33%) relapsed within 1 month. No significant predictors of

their relapses were detected. Of 7 patients with postsuicidal manic

switching, 4 (57%) experienced a switch-down into depression.

 

Conclusion: This study suggests that unipolar depression is significantly

improved after attempted suicide, but also that depressed patients showing

postsuicidal improvement or manic switching are likely to undergo relapse or

switch-down into depression within a short period.

 

(J Clin Psychiatry 2003;64:1210-1216)

 

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p

 

FDA Issues Public Health Advisory On Suicide Risk In Children Taking SSRI

Antidepressants

 

This arrived in my mail box a few hours ago from Vera Sharov of the Alliance

for Human Reserach Protection. -Rick

 

Alliance for Human Reserach Protection

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

FYI

The FDA issued a warning about the suicide risk for children prescribed an

antidepressant of the SSRI class. These drugs have never been shown to be

more effective than placebo for the treatment of depression--which is

supposed to be the criteria for FDA's approval. However, FDA's

acknowledgement that these drugs failed to show effectiveness is offset by

classic bureaucratese doublespeak:

 

" Failure to show effectiveness in any particular study in pediatric MDD,

however, is not definitive evidence that the drug is not effective because

trials may fail for many reasons. "

Klein, Richard M [RKLEIN]

Monday, October 27, 2003 5:03 PM

'veracare'

FDA Issues Public Health Advisory Entitled Reports Of Suicidality

in Pediatric

Vera -

 

This is the announcement of the Public Health Advisory that went up this

afternoon. My understanding is that the advisory itself (see link at bottom

of this notice) is going out to 3,500 individual doctors, and over 160

MedWatch Partners - such as professional organizations and groups that would

be forwarding the message to their members and constituents.

 

I'll see where I can move this from here.

 

-Richard

FDA Talk Paper

T03-70

October 27, 2003

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

 

FDA Issues Public Health Advisory Entitled: Reports Of Suicidality in

Pediatric Patients Being Treated with Antidepressant Medications for Major

Depressive Disorder (MDD)

 

The Food and Drug Administration (FDA) is issuing a Public Health Advisory

to alert physicians to reports of suicidal thinking (and suicide attempts)

in clinical studies of various antidepressant drugs in pediatric patients

with major depressive disorder (MDD).

 

FDA recognizes that pediatric MDD is a serious condition for which there are

few established treatment options. In addition to use of non-medication

approaches to treatment, clinicians must often make choices among drug

treatments available for adult MDD. Currently, Prozac (fluoxetine) is the

only drug labeled for use in Pediatric MDD, and was approved recently under

the Pediatric Exclusivity provision.

 

FDA has completed a preliminary review of reports for eight antidepressant

drugs & shy;- citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone,

paroxetine, sertraline, and venlafaxine -- all studied under the pediatric

exclusivity provision of the FDA Modernization Act (FDAMA, 1997). (Although

fluvoxamine data were reviewed along with the other antidepressant drugs, it

should be noted that it is not approved as an antidepressant in the United

States.)

 

FDA notes, to date, that the data do not clearly establish an association

between the use of these drugs and increased suicidal thoughts or actions by

pediatric patients. Nevertheless, it is not possible at this point to rule

out an increased risk of these adverse events for any of these drugs,

including Paxil (paroxetine), which was the subject of a FDA Talk Paper on

June 19, 2003. That talk paper advised that FDA is reviewing the safety

concerns related to off-label use of Paxil in children based on recent

trials of this drug.

 

FDA emphasizes that, for the seven drugs evaluated in pediatric major

depressive disorder (MDD), data FDA reviewed were adequate to establish

effectiveness in MDD only for Prozac (fluoxetine). Failure to show

effectiveness in any particular study in pediatric MDD, however, is not

definitive evidence that the drug is not effective because trials may fail

for many reasons.

 

FDA is aware of press and medical journal reports of suicide attempts and

completed suicides in pediatric patients receiving antidepressants, and many

such reports have also been submitted to FDA as spontaneous reports. Such

reports are very difficult to interpret, however, in the absence of a

control group, as these events also occur in untreated patients with

depression.

 

FDA emphasized the need for additional data, analyses and a public

discussion of available data. As we recognize that this is a serious

illness, we need a better understanding of how to use the products we have.

 

In order to promote a public discussion of data and pertinent regulatory

actions, FDA has scheduled a meeting on February 2, 2004, before the

Psychopharmacologic Drugs Advisory committee and the Pediatric Subcommittee

of the Anti-Infective Drugs Advisory Committee.

The agency also reminds physicians and patients that these drugs must be

used with caution, both in adults and children. The labeling of

antidepressant drugs already carries precautionary language that the

possibility of a suicide attempt is inherent in MDD and may persist until

significant remission occurs. Close supervision of high-risk patients should

accompany initial drug therapy.

 

In its Public Health Advisory, FDA recommends that caretakers of pediatric

patients receiving treatments with any of these antidepressants talk to

their doctors before stopping the use of these drugs. Patients should not

discontinue use of any of these drugs without first consulting with their

physicians, and for certain of these drugs it is important that they not be

abruptly discontinued.

 

FDA sent the advisory through its Medwatch partners, which includes doctors

and organizations. FDA provides more information on the clinical study data

in its Public Health Advisory, which is available on the FDA website at

http://www.fda.gov/cder/drug/advisory/mdd.htm.

posted by rick giombetti