Turk J (ed).
Universities at Risk. How
politics, special interests and corporatization threaten academic
integrity.
Lorimer Press, Toronto 2008 pp 108-137
Academic Stalking and Brand Fascism
David Healy
Academic Stalking: A Case History
From the early 1990s, using
the example of how companies had marketed antidepressants, in particular the
then new selected serotonin reuptake inhibiting (SSRI) antidepressants, I had
authored a series of articles that illustrated the marketing power of
pharmaceutical companies.[1] This strand of thinking led to the publication in
1997 of a history of the antidepressants.[2] This book was favourably reviewed both by those
supportive of pharmacotherapy and those against it, as well as by reviewers
from the pharmaceutical industry. Company reviewers appear to have been pleased
that industry involvement in the creation of the field was acknowledged instead
of being overlooked, as typically happens in traditional histories of medicine
that feature a series of “great” individuals or academic institutions and
downplay the business side of science and medicine.
I had also from 1991
onwards written a number of articles and made a number of presentations on the
issue of antidepressant-induced suicidality, especially as this linked to the
SSRI antidepressants and in particular to Prozac[3]. In books written for general readers from 1993, I
included the observation that antidepressants could cause problems of this
type.[4] In response, Lilly, the makers of Prozac, invited me
to consult for the company, and otherwise invited me to meetings and were
“friendly.”[5]
The reception for another
article, appearing in 2000, that combined these two themes was quite different.
This article appeared in the Hastings Center Report, one of the leading
bioethics journals in the field, whose Spring issue in 2000 was entitled
“Prozac, Alienation and the Self.” This issue contained five articles on
Prozac.[6] Two of these articles suggested that as Prozac was so
wonderfully effective it would be a mistake to restrict its use simply to
people who are depressed and that it should be available more widely to anyone
who responded to it. Two further articles argued that even though Prozac was
very effective, its use should be restricted to people who are depressed. The fifth
article, by me, argued that Prozac was not particularly effective and that
impressions of its efficacy stemmed in great part from the fact that negative
trials went unreported, that data on the hazards of the drug were concealed,
and that in part this state of affairs was linked to the fact that articles on
Prozac and on other psychotropic drugs were increasingly ghost written.
Following the publication
of this issue, Eli Lilly, who at the time were the biggest single funder of the
Hastings Center, withdrew their support, because the Center had “published
articles that Lilly felt contained information that was biased and
scientifically unfounded and that may have led to significant misinformation to
readers, patients and the community”.[7]
In July that year, at the
British Association for Psychopharmacology’s (BAP) annual meeting in Cambridge,
I presented data on a healthy volunteer study conducted in which two volunteers
who had been blindly randomized to Zoloft (sertraline), one of the Prozac group
of SSRI drugs, had become suicidal.[8] Professor Charles Nemeroff from Emory University was
the guest lecturer at the meeting. Quite extraordinarily in the course of his
lecture, he indicated there was research at the meeting which he felt did not
have a place at an academic meeting. It appeared clear that he was referring to
my work and it seemed likely that when the study was presented in poster format
later that day he would be present.
He appeared at the poster,
and in the course of a brief encounter he made it clear to me that he had been
approached to get involved in legal action against me. He also made it clear
that he thought presenting research of this kind was unlikely to be helpful to
my career, as pharmaceutical companies roll over people who are awkward to
them.
Finally, at the end of
November 2000, the University of Toronto and the Centre for Addiction and
Mental Health hosted a meeting to celebrate the 75th anniversary of
the university department and the 150th anniversary of the mental
health services in Ontario. I was one of the guest speakers at the meeting. At
the time I was scheduled to move to the University of Toronto, having been
interviewed for and offered a post as Professor of Psychiatry earlier that
year. The distinguished collection of speakers for the meeting included Dr.
Nemeroff. The audience was invited to evaluate both the content and
presentation of talks afterwards. My talk was rated the highest on the combined
scores.
During the course of that
day, I gather Dr. Nemeroff made it clear to members of the university that it
would be a mistake to hire Healy. Later that evening I had the first
intimations that my appointment was in jeopardy. The following morning, as I
understand it, Dr. Nemeroff told colleagues at meetings in New York that Healy
had lost his job. A week later I had an email confirming that my contract with
the university was terminated.
Stalked
I contested the
termination. The story broke in April 2001.[9] and the media approached me for my side of the
issues. They also approached the university, who declined to comment but
directed reporters to a Dr. James Coyne, then at the University of
Pennsylvania, indicating that Dr. Coyne would be able to comment on Healy.
I had never heard of Dr.
Coyne. His remarks appear to have been intemperate, and none of the outlets
that covered the story featured his views. This led him to write letters, the
first of which was published in the University of Toronto Bulletin, in which he indicated the only odd feature of what has
come to be known as the Healy affair was that the university had seen fit to
consider hiring Healy in the first instance, as he had little research to his
name and his healthy volunteer study was poor from a methodological point of
view and likely unethical.[10] Dr. Coyne sent a number of comparable contributions
to locations, including Web sites, where they could be posted without
oversight.
Who was James Coyne? I
later found that he had consulted for a number of pharmaceutical companies,
including Lilly, and also that he had links with Chamberlain Communications, a
New York-based PR agency working for Lilly. He was a psychologist who had
previously been employed in Ann Arbor, working on depression.
From 2000 onwards, Dr.
Coyne made regular and colourful contributions to a Society for Scientific
Clinical Psychology (SSCP) listserv berating me and my research and anyone who
offered me support on the issue of whether antidepressants could trigger
suicidality.[11] This was not a listserv on which I was a participant.
I only became aware of the contents some years later.
In a posting on 9/11/01,
before other news broke that day, referring to Healy he stated: “He had not
only BEEN an expert witness when he published that article, he was ACTIVELY a
witness in an unresolved civil suit in which it was crucial that he be able to
cite data for his otherwise unsubstantiated position that SSRI's make people
suicidal. Releasing the paper to accomplish that was both timely and sleazy,
and all the more so because he did not disclose his relevant financial
interests in the study having a particular outcome. His testimony and
soliciting of law suits was quite germane to any effort to make sense of his
bizarre report and I doubt many readers understood the connection….
Incidentally, when it is convenient, Healy accepts considerable money from drug
companies, more than most people I know.”
Many of the claims made by
Dr. Coyne in his postings and correspondence regarding the Healy affair
contained claims and assertions about me that were only otherwise being made to
my knowledge in briefings to the media by Lilly, Pfizer and GlaxoSmithKline
(GSK).
The types of materials
aired by Dr. Coyne found an echo in a posting by Pfizer on the US FDA’s Web
site in July 2004. This posting was linked to a drugs advisory committee
meeting to consider the issue of suicidality on antidepressants given to
pediatric patients. An earlier meeting in February 2004 had indicated there
appeared to be a problem—antidepressants made minors suicidal. The FDA had
deferred handling the issue further for a period of half a year on the basis
that the agency needed to analyze the data further. Prior to the second hearing
in September 2004, interested parties were allowed to make postings on the
FDA’s Web site and Pfizer did so.
The Pfizer letter was a
fifty-page billet-doux extolling the character and science of David Healy in
terms such as the following:[12]
Dr. Healy has distorted
and mischaracterized the evidence. . . many erroneous statements, unsupported
contentions and data distortions. . . .
Dr. Healy has been hired
by lawyers representing civil-litigation plaintiffs and criminal defendants to
criticize SSRIs in at least 8 cases. Although he is a psychiatrist and reader
at the University of North Wales, he is primarily known for his work as a
medical historian. He has little scientific experience in conducting and
interpreting the results of controlled clinical research. . . .
Before becoming a
litigation expert witness testifying against SSRI manufacturers, Dr. Healy
published views opposite to those he now espouses on the question of whether
SSRIs induce suicide.
This material contains a
number of claims that appear to me actionably false, but taking an action
against a pharmaceutical company seemed counter-productive in that any legal effort
would likely distract my attention from other important work, and it seemed to
me quite likely that Pfizer and other companies had this possibility in mind.
FDA denied me a right of reply, but I have since
published a reply.[13].
Aside from postings on the
SSCP listserv, Dr. Coyne’s stalking took more concrete form in 2005. I was
aware from postings on the listserv that he was writing or proposing to write
an article on the Healy affair. When an article on the “Martyrdom of David
Healy” finally appeared in the American Journal of Bioethics, it was only published online. There
was no hard copy.[14] The journal refused a right of reply. The article is
in many respects curiously unfocused, but from its title onwards it conveys the
impression that Healy has a lot to answer for.
This article led the Collegium
Internationale Neuro-Psychopharmacologicum (CINP), the leading
international psychopharmacological association, of which I am a member, to
institute an investigation. Curiously this investigation and apparently a
number of other investigations of the Healy affair have been able to proceed
without consulting me at any point.
The Coyne article set up a
debate, scheduled for Columbia University in October 2005, supposed to feature
Dr. Coyne and myself. I turned up, but Dr. Coyne did not. Subsequently, Dr.
Coyne posted on the SSCP listserve a series of comments on Healy and Healy’s
positions, which I presumed were the kinds of things that he would have said in
the debate. These comments and my replies have been posted on the Alliance for
Human Research Protection and healyprozac.com Web sites.[15]
The most ominous
development in relation to the Coyne article came in March 2006 when I had a
letter from the General Medical Council (GMC) in the UK, the body responsible for
the registration of doctors. Investigation by the GMC can lead to a doctor
being struck off. The letter from the GMC started “Dear Healy, . . .”
Letters like this from the
GMC must also include the letter of complaint. The GMC is headed by Sir Graeme
M. Catto. Ordinarily letters to Dr. Catto would be addressed “Dear Sir Graeme,”
but this letter of complaint was addressed “Dear Graeme, . . .” It was from
someone I would have considered a relatively close professional colleague,
Professor David Nutt, the Professor of Psychiatry and previously the Dean of
Medicine at Bristol University. This letter referred Dr. Catto and the GMC to
the Coyne article, which “raises serious concerns about the scientific and
ethical conduct of Dr. Healy. . . . Is this something the GMC should be
concerned about?”[16]
Complaints to the GMC often
take years to run their course. Individuals being complained about find the
process highly stressful. In this instance, the correspondence surrounding the
complaint was fast and furious. It has been laid out in its entirety on
healyprozac.com. Using freedom of information provisions, I was able to
establish that Dr. Nutt and colleagues had apparently drafted several letters
to the GMC to complain about me, but it would seem had lacked a clear focus for
a complaint until the appearance of Coyne article.
Dr. Nutt’s closest
collaborator in the exercise of drafting a letter to the GMC appears to have
been Dr. Guy Goodwin, the Professor of Psychiatry at Oxford, another colleague
I would have regarded as relatively close. In 2000, I had given a lecture in
Oxford at Dr. Goodwin’s invitation on the history of the antidepressants and
issues to do with suicidality on these drugs.
In 2003 in the course of
legal work, I had visited Pfizer in New York to look for documents the company
might have on rates at which children in the clinical trials of their
antidepressant, Zoloft, had become suicidal. Almost all of the documents
related to pediatric suicidality were apparently missing from the archives when
I was there, but a vast number of pages remained. There had therefore to be
considerable odds against finding any single loose page amongst this material.
But a loose page came to hand that appeared to be notes of a telephone call
that had been made by an employee of Pfizer to Dr. Goodwin following the
lecture on antidepressants and suicidality I had given in Oxford.
These notes may have been
taken entirely without Dr. Goodwin’s awareness. He appears to have been asked
to give an account of what I had said in my lecture, and may also have been
asked for, or volunteered, further information on issues to do with me that
might be of interest. It seems likely to me that someone gets approached in
this way after all my lectures, and that something similar probably happens
when anyone critiques the pharmaceutical industry.
Presented with the evidence
of serial complaints by Drs. Nutt and Goodwin and apparent plotting on this
issue, together with information on Dr. Coyne’s background and links and his
failure to engage on the issues, and the co-incidental emergence of a letter
from GlaxoSmithKline that conceded their antidepressant, Paxil, was linked to a
two-fold increase in the risk of suicidality, the GMC chose to draw their
investigation to a close some months later. Their letter informing me of this
contains a phrase to be cherished: “The paper by James Coyne represents an
alternative view and perspective, which is encouraged in the arena of academia
and research.”
Handling
Academics
This case history needs to
be read in a context that includes the role of PR agencies such as Chamberlain
Communications, with whom Dr. Coyne had links. When a new drug is launched or
when an old drug needs to be defended, public relations companies like this
have a brief to handle some of the problems in the field that the new drug
might face, including perceived critics.
The kind of “handling”
involved can be seen in the example of what happened to another clinician who
questioned the received wisdom on Prozac, Joseph Glenmullen. In 2000 Dr.
Glenmullen published Prozac Backlash, a book that details hazards linked to treatment with the SSRI
antidepressants Prozac, Paxil, and Zoloft. On its launch Chamberlain
Communications in New York, and other communications agencies working for
Lilly, such as Rasky Baerlein in Boston, sent reviews of the book by eminent
figures in US psychiatry including John Greist, Tony Rothschild, David Dunner,
Graham Emslie, and Harvey Rubin to media outlets such as Newsday in New
York and the Boston Globe. These reviews from some of the more eminent
figures in American psychopharmacology broadly state that Prozac Backlash was an unfortunate book that emphasized the hazards
of treatment without detailing the benefits. The reviewers feared that such a
book would put people off seeking treatment and that the failure to seek
treatment might lead to their suicide.
The reviews sent to Newsday arrived with a covering letter
from Robert Schwadron of Chamberlain Communications, who asked Newsday
to take these reviews into account. Schwadron went on to indicate that he could
arrange for Newsday to
have interviews with people from Lilly and with “independent researchers” to
balance the views in Prozac Backlash.[17]
This system of controlling
the message does not necessarily require people to change their views in return
for money from a pharmaceutical company. The companies’ power lies in their
ability to select the views that suit their interests and to ensure a wide
distribution of these views, rather than in their abilities to buy off opinion
leaders, although the latter almost certainly also happens.
Even before I had lost my
job in Toronto, both Dr. Glenmullen and I had become problems for Chamberlain
to handle, in my case likely owing to the fact that as of 1999 I had become an expert
witness in legal cases against all three major SSRIs. It is possible that at
least three different PR agencies working for the respective companies had
Healy briefs.
Around that time, I became
aware from colleagues as far away as Japan that American academics linked to
pharmaceutical companies—who had never met me, heard me talk, or engaged with
me on any of the issues I had raised—were spreading the word that Healy was
trouble and likely to be in trouble and anyone linked to him risked being damaged
by association.
A subsequent freedom of
information request to Lilly UK threw up 109 items. The contents of items 103
and part of 104 are reproduced here:[18]
103: Healy long term
strategy.
Thank you for the message
outlining your strategy to counteract Dr. David Healy’s claims re: Prozac and
violence.
Send a letter to Healy
designed to get him to stop discussing a study that he has never done.
Have a third party expert
in the audience at BAP to ask Healy questions when he presents.
Just last Thursday Healy
was quoted in a Cincinnati paper saying Prozac causes violence and suicide . .
. . X has asked that we go back to legal and determine if we can sue Healy
under UK law.
104: Huge turn out. . . .
Good talk. Lesson no sponsor if Healy present in future.
I have been informed by
several colleagues in pharmaceutical companies that they had been told they
could not have me as a speaker at meetings they organized. Efforts were made at
meetings where I was scheduled to speak, such as the International Society for
Pharmacoepidemiology, to have me disinvited right up to the last minute. Funds
already committed by pharmaceutical companies to meetings were withdrawn in a
manner that appeared linked to positions I was taking. None of this is unusual;
others such as Adrienne Fugh-Berman have reported similar experiences.[19]
I also learned through
emails that a number of what were described as national (American) meetings had
supposedly been held to discuss the Healy issues, and speakers or other
materials at these meetings had made it clear to participants that those who
supported Healy were simply not aware of the facts. These meetings were held
without any input from me and even without my awareness.
Despite having good links
to most major psychopharmacology forums, it proved almost impossible to get the
issues of antidepressant-induced suicidality onto the agenda of any meetings.
On the rare occasions when debates were set up, such as at an Irish psychiatric
meeting in 2003, my opponents and the chair were briefed by pharmaceutical
companies with material that overlapped heavily with Coyne and Pfizer material.
Finally, in the midst of
my difficulties with the GMC in 2006, I had another difficulty. The Internal
Revenue Service (IRS) in the United States made it clear they thought I owed
them over $30,000 for the years 2001 and 2002. This covered tax they regarded
as unpaid, the interest on unpaid tax, and fines for non-payment. It seemed
quite likely that something similar would unfold for 2003, 2004, and 2005, and
indeed for subsequent years.
Britain and America have
a tax treaty which allows an individual to pay tax in one jurisdiction only.
Aware of possible developments of this sort, I had ensured that all of my
accounts had been professionally handled from 1997 onwards, and that all tax
had been paid. Within the UK, I had been subject to several reviews in the
years from 2000 onwards, to the surprise of my accountant. My accountant was,
however, unable to help me with the American tax authorities. I had to seek
help from an American accountant. (The IRS ultimately concluded they owed me
money, but I continue to have to file tax returns in both the US and UK.)
In 2004, at the time of the
hearings on the risks of suicidality in pediatric populations linked to
antidepressant intake, the FDA’s associate commissioner for external relations
was Peter Pitts, whose challenge it apparently was “to clearly define FDA’s
brand image.”[20] Pitts later went on to be a prominent figure in the
Centre for Medicine in the Public Interest (CMPI). This proclaims itself as “a non-partisan, non-profit educational charity, whose Mission is to
discuss, debate and demonstrate how exponential and accelerating technological
progress coupled with smart public policy will enhance and advance 21st Century
health care by predicting, preventing, diagnosing, and treating diseases with
greater speed, more precision and less cost.”
CMPI runs a Web site,
http://www.drugwonks.com/. As the Internet has become a source of information
on the development and the hazards of drugs and on health in general,
pharmaceutical companies have learned how to ensure that pharma-friendly sites
come up early on Internet searches and hostile sites do not. Drugwonks.com
comes up early in searches for information on antidepressant hazards. A
prominent figure posting here is Peter Pitts, who writes about critics of
pharmaceutical companies, such as David Healy.
Given the huge body of
evidence that the decline in the use of antidepressants has fueled an increase
in suicides, the fearmongers now blame the use of anti-psychotics. That
includes David Healy, the well-paid expert witness for trial attorneys now
suing the likes of Eli Lilly who make anti-psychotics. Can we say conflict of
interest? Where will Healy, David Graham and the rest go to wash the blood off
their hands[21]
Mr Pitts is also a
vice-president for Manning, Selvage and Lee. MS&L “is ranked among the
world’s top healthcare communications practices. We specialize in health
policy, direct to consumer, health policy, medical education, third party
alliances and strategic communications around key pharmaceutical benchmarks
including medical meetings, advisory committee meetings, product approvals and
launches.”[22] Its clients include Eli Lilly, Pfizer and
GlaxoSmithKline.
Conversely. other sites
such as http://furiousseasons.com/, or clinpsyc.blogspot.com which may feature
material on the hazards of psychotropic agents, are regularly trawled by legal
offices, PR agencies and other groups linked to pharmaceutical companies for,
among other things, references to the views of or work of David Healy.
All of the experiences
above find echoes in the accounts of what happened to Nancy Olivieri,[23] Aubrey Blumsohn,[24] and John Buse,[25] among others. Marketing departments arrange for
critics of current products to be marginalized or silenced in a manner that
fits well with fascist traditions of the 1930s, 1940s, and 1950s. Anyone who
criticizes a brand is likely to have “friends” planted in the audience to
monitor what they say and if need be challenge it; is likely to have their
utterances or writings scrutinized for possible legal actions; is likely to find
“friends” and colleagues have been mined for information; is likely to find
“friends” complain them to whatever body monitors their registration as a physician;
is likely to have all their emails and telephone calls monitored, and is at
distinct risk of losing their job.
Censoring Academia
The current academic scene
involves a number of other factors and forces. There is more involved than just
individual stalkers operating in a climate facilitated by PR agencies. Whatever
the fate of individual academics in the past, science in general has been
viewed as relatively unaffected by passing commercial concerns, but the SSRI,
osteoporosis, and other stories noted above involve a distortion of the science
base. And it is this distortion, and the ability of companies to get the
majority of academics to buy into distorted versions of the facts, that
isolates academics from the herd and makes them vulnerable to being stalked.
For most academics it is
probably close to inconceivable that scientific journals and meetings might be
censored. Those a little wiser to the ways of the world might concede there is
a certain amount of interference in areas that bear on commercial sensitivities
but nothing that could conceivably be called censorship. Readers are likely to
think the difficulties surrounding the Hasting Center Report mentioned above,
must simply have been an aberration, one that likely backfired on the company that
withdrew its funding.
The alternate explanation,
namely that the way Lilly treated the Hastings Center has come close to being
the norm for the way companies treat academic journals and meetings, would need
to be substantiated. With this in mind, consider the following 11 cases.
1. In 1999, having agreed
to testify medico-legally in a case involving homicide and suicide on Prozac, I
became aware of documents shedding light on the propensity of Prozac to trigger
suicidality and of company efforts to avoid warning of the risk. The documents
were in the public domain but few were aware of their existence. My immediate
thought was to write an article outlining the material for the British
Medical Journal (BMJ).
When the question of
Prozac-induced suicide was first raised in 1990 and the first legal actions had
been filed against the company, the BMJ carried an article with a
company-only authorship line that, despite demonstrating a 1.9-fold increased
risk of a suicidal act on Prozac compared to placebo, was widely spun as
evidence that there was no risk from the treatment.[26] This article drew an intriguing response from a
professor of psychiatry who had a history of difficulties with the
pharmaceutical industry: “The BMJ is a journal of distinction and, dare I say
it, perhaps also of some innocence. At a time when in the United States the
manufacturer of fluoxetine is facing litigation, the corporate defense
attorneys will be pleased by the journal having published a piece authored
wholly by the manufacturer’s employees.”[27]
The initial BMJ response to my submission was
encouraging. The editor suggested reframing the article for the education and
debate section of the journal. A revised article was sent to a reviewer, who
was apparently not told that it was an education and debate article about
company behaviour and not an evidence-based assessment of the case for
Prozac-induced suicidality. The reviewer suggested the article had not
established the case for treatment-induced problems—which it had never
attempted to do. The editor rejected the piece on this basis. Mystified at the
mismatching messages, I appealed but in vain, with the editor in a phone call
stating that no matter what revisions I made nothing would be published.[28]
This article was published unaltered in the International
Journal of Risk and Safety in Medicine, whose editor, Graham Dukes, commented that “It seems to me
your approach is original and fair. . . . I had not seen the
issues of litigation, regulation and patents juxtaposed in this way before. . . .
I agree entirely from my own experience with many of your comments; there are
some striking examples of companies tenaciously hanging onto a profitable and
patented drug despite the evidence that it is doing more harm than good. Their
motives are a mixture of opportunism and genuine belief that the product is
being wrongly accused. I also agree with your remarks about the failure of the
present overall research approach to elicit a reliable picture of adverse
effects and the sometimes unrealistic defenses put up by industry when their
products are the subject of injury litigation.” The article was given guest
editorial status to emphasize its message.[29]
2. A year later, having
conducted a blind and randomized trial in healthy volunteers, in which two volunteers
had become suicidal on an SSRI, I again contacted the BMJ about a
submission but was told there was no point submitting the article. This was the
research that so exercised Drs. Coyne and Nemeroff. My assessment of the
situation suggested seeking publication instead in a journal whose editors had
previously worked within the pharmaceutical industry, on the basis that this
background would make them less rather than more nervous about offending
industry. The paper was reviewed and rapidly published.[30]
3. Subsequently, I submitted
a data-driven article to the British Journal of Psychiatry on ghost
writing, whose key finding was a majority of articles that deal with
pharmaceutical products in our leading journals are likely to be ghost written.
This journal usually has two peer reviewers. In this case a clearly nervous
journal used at least five reviewers and had the revised article re-reviewed.
The article was subsequently referred to the legal department of the journal
and the copy editors for the journal spent a great deal of time working on the
final version.[31]
4, 5, 6, & 7. Around this time a much smaller journal, Contemporary
Psychology, requested a review of Joseph Glenmullen’s Prozac Backlash.
My review outlined the key points made by the book, without endorsing the
position of the author. It added that I was in possession of five highly
critical reviews of the book by distinguished American psychiatrists, with
accompanying documentation from public relations agencies working for Lilly
providing these reviews to media outlets and encouraging them not to feature
the book. I sent the review and the accompanying documents to the editors. The
review was initially accepted but failed to appear. On enquiring I was told
that the journal could not find a balancing reviewer and so they could not
carry my review. The response made little sense.
When the issue of
antidepressant-induced suicidality in pediatric populations emerged, Open Minds and Young Mind requested pieces on the
issue. Both journals declined to publish on what I was told was legal advice.
They made it clear the decision was entirely based on the assessment that they
did not have the resources to handle any difficulties they might run into with
pharmaceutical companies as a result of publishing the articles, and to invite
such problems could put them out of business.
In
2005 the Times Higher Education Supplement (THES) featured a series of articles on Aubrey Blumsohn who had
“blown the whistle” on Sheffield University and Proctor and Gamble over company
concealment of data on the response to therapy with risedronate, a treatment
for osteoporosis (See Blumsohn’s chapter in this book). A series of letters
were submitted to THES commenting on
aspects of the case. Mine sought to make clear that Blumsohn’s case was not
unique. THES amendments to the letter
stripped its meaning. I suggested their revisions made the letter pointless, to
which they responded: “We have also had to run these letters past our
lawyers as this is, as you are aware, a very sensitive issue, and there are
certain legal amendments we had to make.” They did
not publish any letter from me.
8. In 2004 Evidence Based Mental Health approached
me to provide a 300-word commentary on a Journal of the American Medical
Association (JAMA) article
on antidepressants and suicide by Herschel Jick and colleagues.[32] This article, which appeared in the midst of controversy as to whether
newer antidepressants might trigger suicidality in minors, appeared to
exonerate these antidepressants of any risk. Following its publication the FDA
requested Dr. Jick to make available a further analysis that the published data
obviously called for but which the manuscript did not include. This analysis
suggested the newer antidepressants were riskier than older ones. My commentary
used this new data from Dr. Jick as a comment on their methods.[33]
This seemed to be an
unusual development for the journal. Frontline staff invoked the senior
editors. Despite my contention that the best way forward surely was to have new
evidence made available, perhaps with an accompanying comment by any other
party of their choosing, the journal decided instead to abandon any comment on
Dr. Jick’s article. In follow-up correspondence I noted:
I think looking at the
confidence intervals in the originally published version, it was pretty clear
that a reanalysis of the figures would throw up problems for anyone who was
committed to the view that SSRIs pose no problems. And that's just what a
reanalysis did.
JAMA has also published
another article on the Treatment of Adolescent Depression (TADS) where again
the abstract and headline and content are at variance with the data from the
study, which by strict criteria is a failed Prozac study. But JAMA have turned
down pretty well all correspondence on the Jick article or the TADS, while
running lengthy commentaries praising these same articles, both of which have
also attracted front page New York Times and Boston Globe coverage. At the same time I and colleagues have sent a
meta-analysis of all 677 [published] SSRI trials to JAMA, who have turned it
down on the basis of a point that could be handled by a simple rewording. Make
what you will of this. (Email D.H. to S. Vincent of Evidence Based Mental Health,
October 29, 2004).
In the view of my colleague authors and I, the JAMA
reviews had not pointed to any substantive problem with our article and
indeed the BMJ later accepted the same article essentially unchanged. It
has been among the top three cited articles in the BMJ in recent years.[34]
9. In 2005, BMJ had a new editor, and I submitted an
article on how the data on suicide and antidepressants had been manipulated. The peer
reviews were longer than the original paper. After I’d answered all queries
from both a first and second round of peer reviews, the paper was accepted. In
the middle of correcting the proofs, I received an email from the editor:
“Thank you very much for all your hard work on this article. I'm afraid we've
run into a legal wall with our libel lawyer reluctant for us to publish your
piece. . . . I remain supportive of publication but obviously can't do this
against legal advice.”
Eventually, possibly
because of my persistence, a year and a half later the article was published.[35] The wording had been minimally altered to emphasize the failings of the
regulatory authorities for the corrupted data in the public domain and to
de-emphasise any company failings.
10: Study 329 was the key
study of GlaxoSmithKline’s SSRI antidepressant, paroxetine, in depressed
children. Faced with the results from this trial, company documents show GSK
had concluded in 1998 that the drug didn’t work, that the data could not be
presented publicly, or even shown to the regulator. Nevertheless the “positive”
aspects of the data would be selected for publication.[36]
In 2001 an article
reporting the results of Study 329, apparently authored by some of the most
distinguished psychopharmacologists in America claiming paroxetine was safe and
effective for children, appeared in the Journal of the American Academy of
Child and Adolescent Psychiatry (JAACAP),
the journal with the highest impact factor in child psychiatry.[37] In fact the paper was primarily authored by a medical writer, Sally
Laden.[38] The selected data and claims presented in this
paper were presented at a series of meetings by the “authors,” and sales of
this drug, whose use in children was unlicensed, soared.
This is not the only case
of its type. As of 2004, when concerns about antidepressants given to children
blew up, from material available to me it appears that 100 percent of the
published literature was primarily authored by medical writers or
pharmaceutical company personnel. The ghost writing of these articles was,
however, only a minor issue. The real problem is that there was a comprehensive
divide between what the articles universally claimed, namely that the drugs
were safe and effective, and what the raw data later showed. This is the
greatest known divide in all of medicine between what the published literature
and the actual trial data show, but the processes that gave rise to this divide
can be reasonably assumed to apply as well to all other areas of therapeutics.
Asked baldly on BBC’s
investigative Panorama program whether she would retract Study 329 or
regretted its publication now that it had been shown to be ghost written and
misleading, the editor of JAACAP said No. More generally the editors of
our leading medical journals have attempted to clean up the mess posed by ghost
writing and lack of access to the underlying data from company studies by
asking for authorship declarations and conflict of interest statements, rather
than seeking to require companies to make raw data available.
11.
In 2007 I was approached by Index on Censorship
“for a piece outlining
evidence that pharmaceutical companies are not transparent and that medical
journals allow this to happen. The implications of this for doctors and the
general public would also have to be spelt out. You put it very succinctly when
we spoke—pharmaceutical companies get to publish articles in major journals
under the banner of science but they don't conform to the norms of science. The
fact that there's this curious “gentleman's agreement” which means that
pharmaceutical companies don't have to produce their data should also of course
be mentioned. . . . I think to an outsider who has certain
expectations of science (that data is widely available and that access to data
is fundamental in terms of any credibility) it's a baffling and shocking state
of affairs”.
The resulting article
covered the evolution of ghost writing, and the lack of access to clinical
trial data, focusing on Study 329. An iterative process began that finally got
to the lawyers:
“Our lawyer's just taken
a look at your piece—and I do need to ask you for more chapter and verse on
some points.
I realise this is taking
up more of your time than you bargained for and do apologise—lawyers must make
you weary by now—but am sure you'll understand that it's necessary.”
The process ended with:
“The documents made
interesting reading—and certainly answered the concerns—along with the cuts.
But I've still got worries about running the piece. . . . I
regret how things have turned out very much. I've appreciated all your help in
finding documents and in cooperating with all my requests. As I've said
before—it's a hugely important subject and we should be covering it.”
Index on Censorship
self-censored.
12. The difficulties with
publication of a critique of 329 do not seem to be solely due to its author.
Following the emergence of evidence that SmithKline Beecham (later Glaxo
SmithKline (GSK)) had viewed 329 as a failed study but nevertheless considered
selecting the good bits for publication, the Lancet published an
editorial, “Depressing Research.”[39] Subsequently, the journal published a letter from A. Benbow of
GlaxoSmithKline claiming the company were transparent on all issues to do with
clinical trials. Leemon McHenry and Jon Jureidini wrote to the Lancet
taking issue with Benbow’s claims in a letter, clearly stating that as an
expert in a legal case involving Study 329, Jureidini had a conflict of
interest. The Lancet agreed to publish their letter, but sent it first
to GlaxoSmithKline, who replied that it would not seem appropriate to publish
the letter given Dr. Jureidini’s role as an expert witness involving these
issues, implying that seeking publication in the Lancet was a tactic
designed to achieve a legal advantage. On this basis the Lancet declined
to publish McHenry and Jureidini’s letter, even
though the original Benbow letter could as readily be construed in this
fashion, as New York State had taken a fraud action against GlaxoSmithKline for
their lack of transparency in 329 and related studies, which the company later
settled.[40]
McHenry, Jureidini and
Peter Mansfield wrote a further paper on Study 329, “Clinical Trials and Drug
Promotion: Selective Reporting in Study 329.” The BMJ editor wrote to them saying she had heard of their paper and
wanted to fast track its publication. Six months later, after revisions, the BMJ
indicated their lawyers still had concerns and they would not publish.
In contrast to these
difficulties in getting articles published, the process of publishing
ghost-written articles in major journals appears to be straightforward. In a
2006 JAMA editorial, Catherine de Angelis tackled the issue of why
leading journals could not ban further articles from those linked to tainted
articles saying that “Levelling sanctions
against an author who fails to disclose financial interests by banning
publication of his or her articles for some time period would only encourage
that author to send his or her articles to another journal; it cleans our house
by messing others. So what about all editors, or at least a group, such as the
ICMJE (International Committee of Medical Journal Editors), agreeing to share
the information and jointly to ban the offending authors? Those who suggest
this approach have not considered the risk of an antitrust suit.”[41]
This statement appears to concede that “scientific” journals cannot
insist that contributors adhere to the norms of science by, for instance, being
able to make publicly available the data on which their claims are based. This
being the case, to avoid misleading a wider public, it might be better if
publication outlets unwilling to commit to the norms of science were
redesignated as periodicals rather than journals.
Company power can be seen
in the sequence above. Such pressure tactics are another means to ensure that
views not favourable to company interests get closed down. There must be many
other instances of journals self-censoring but where the authors have no idea
why they have been rejected or no way of proving their suspicions. The effects
on academic discourse can only be profound.
The process affects the
most prestigious journals in the field—as does the ghost writing, which now
affects the most prestigious journals in the field primarily. Where once ghost
writing happened in obscure journals, the bulk of articles linked to
pharmacotherapeutics appearing in JAMA,
the New England Journal of Medicine,
and the Lancet are now likely to be
ghost written. The agencies responsible for writing these articles trawl the
offices of academic journals to find out which journals might be interested in
material on a particular issue in order to speed the publication of their
product. Such articles will not be impeded on their way by any considerations
about incurring a legal action.
On the one hand, companies
appear to be able to block the publication of material inimical to their
interests, even when this stems from clinicians or others doing what they are
legally supposed to be doing—namely reporting on treatment hazards—while on the
other hand our journals are ever more full of material that does not conform to
the basic norms of science, namely to make available the data on which claims
are based.
Systematic action on behalf
of companies or related public relations agencies to damp down the effects of
publications that do not suit their interests, added to the increasing
willingness of journals to effectively self-censor out of fear of the legal
consequences of publishing material that is not in the interests of the
pharmaceutical companies, puts in place the conditions to recreate a climate
not unlike that in Germany in the 1930s and the Soviet Union in the 1950s.
I grew up in Ireland in the
1950s and 1960s, a period when Catholic censorship meant that work by Joyce,
Beckett, Kiely, Broderick, McGahern, O’Brien, Dunne, Moore and many others were
banned in Ireland because they tackled sexual issues.[42] But it is a moot point as to whether that censorship
was any more draconian than the current censorship. Having prided ourselves on
finally overcoming Catholic, Nazi, McCarthyite or Soviet censorship, we perhaps
think this could never happen again. We fail to see what is happening and to
call it what it is. One symbol of the shifting forces is the contrasting
experiences of John Cornwell, who wrote books on the risks linked to Prozac[43] and on the inaction of the Vatican vis-à-vis the extermination of Jews
in the Second World War.[44] Where once incurring Vatican wrath, as the second book did, might have
been a cause for concern, but is no longer as Cornwell found, incurring the
strong displeasure of Lilly, as the first book did, led to warnings of legal
action against Cornwell in multiple jurisdictions.[45]
Brand Fascism[46]
Since the 1950s, a wealth
of new drugs has come into medicine. The 1950s also saw the emergence of
randomized controlled trials (RCTs), and many thought these methods would help
curb the excesses of the pharmaceutical industry. Finally the new drugs were
made available as prescription-only from doctors, who it was thought were less
likely to be influenced by industry than non-professionals and better able to
understand research and its implications.
However, while in the 1950s
these new treatments saved lives that would otherwise have been lost and
extended the compass of human freedom, forty years later we have moved instead
into a world in which pharmaceutical products appear to be contributing to
reductions in life expectancy, a degradation of the scientific and academic
base of medicine, and the emergence of a medico-pharmaceutical complex that is
making the discovery of agents for illnesses that need to be vanquished less
likely, while at the same time pathologizing a range of life’s vicissitudes and
variations.
Key
to all this has been the emergence of the marketing departments of
pharmaceutical corporations as one of the most potent cultural forces in our
world today. They have been able to suck into their ambit the academics who
were supposed to act as a counterweight to industry, as well as the apparatus
that was supposed to regulate companies, and have in addition transformed those
in the media, who distrust every politician whose lips move, into the willing
bearers of the good tidings of salvation through pharmaceuticals. Their
operations also engineer a situation in which most academics view the efforts
of clinicians to fulfil their legal duty to draw attention to the hazards of
prescription-only agents as an attack on clinical medicine. As a result, the
most distressing attacks on clinical academics typically come from other
academics.
The
Levers of Power
The new marketing has
availed of the use of brands, a weakening of patent laws, an industrialization
of the clinical trial process, the willingness of physicians to be sold
diseases, and their inability to manage uncertainty. But above all it has been
aided by physician ignorance of marketing.
While brands such as Nike
and Reebok are household names, pharmaceutical brands are the oldest and most
profitable brands. The industry turned to branding in the late nineteenth
century with astonishing success, as evidenced by Aspirin and Heroin, which a
century later still have greater recognition than their generic compounds. With
the SSRIs, there has been a much greater investment in these brands than in any
other branded products from non-pharmaceutical domains.
Companies brand more than
the names of drugs. They can conjure into existence notions such as mood
stabilizers, a term that did not exist before the mid-1990s but which is now
among the most commonly heard terms within psychopharmacology. Diseases like
manic-depressive illness can be rebranded as bipolar disorder, as part of a
transformation aimed at persuading clinicians and others that a disorder that
until recently was thought to occur at a rate of approximately ten new cases
per million per year, affects 5 percent of North Americans—16.5 million people.[47]
Two developments in the
patent systems in the US and elsewhere made an increased focus on brands
possible. First, where these patent systems once aimed at rewarding substantial
novelty that clearly contributed to public utility, the US system in particular
has moved toward rewarding even novelty with diminishing regard for evidence of
benefit. Thus Abbott gained a patent on semisodium valproate for mania and
created Depakote, even though the off-patent sodium valproate had already been
demonstrated to be useful for mania since the 1960s.[48] Lilly was able to get a patent on olanzapine and
create Zyprexa for schizophrenia and mood stabilization on the basis that it
was less likely to produce lipid elevations in dogs compared to a never
marketed compound, when in fact this drug raises lipids in humans more than
almost any other drug in medicine.[49] This relaxation in the application of patent laws in
the US to the point where compounds with no novelty and no utility can now be
patented may be linked to a calculated attempt to seduce pharmaceutical
companies to the United States.
Second, in the 1960s, older
laws enabling companies to take out process patents were phased out in favour
of patents on products, so that only one company could have a fluoxetine. This
has enabled companies to embark on the creation of brand blockbusters such as
Prozac, Depakote and Zyprexa. As a consequence. companies have a much greater
incentive than ever before to aggressively defend their compounds and conceal
their hazards.
Thus talking about early
difficulties Lilly had with reports of suicidality on Prozac, one of their then
senior scientific officers, Leigh Thompson, put the issues like this: “I am concerned about reports I get re UK attitude toward Prozac safety.
Leber (FDA) suggested a few minutes ago we use CSM database to compare Prozac
aggression and suicidal ideation with other antidepressants in UK. Although he
is a fan of Prozac and believes a lot of this is garbage, he is clearly a
political creature and will have to respond to pressures. I hope Patrick realizes that Lilly can go
down the tubes if we lose Prozac and just one event in the UK can cost us
that.”[50]
More recently company
marketing documents linked to Zyprexa make the stakes clear: “The company is
betting the farm on Zyprexa… the ability of Eli Lilly to remain independent and
to emerge as the fastest growing pharma company of the decade depends solely on
our ability to achieve world class commercialization of Zyprexa.”[51]
World class
commercialization has been achieved by, among other things, the following
developments. First, companies gained control of clinical trials in the 1980s,
when clinical research organizations (CROs) took over from academic physicians
as the organizers of trials. As of 2000, CROs ran more than two-thirds of
clinical trials undertaken by industry, worth $30 billion. Privatized research
of this sort is profoundly different from previous clinical research. CROs have
transformed human subjects research, restructured controls of disclosure and
confidentiality, managed intellectual property in an entirely new way by for
instance sequestering RCT data in a way
that did not happen when a federation of academic centres conducted trials.
CROs provide a privatized
institutional review board system (ethics review) that grants ethical approval
to company studies, when university centres might not. CROs have made it
possible to move trials on drugs for Western markets into Asia or Africa, in a
way that university departments could not have done. Whether this move has been
prompted by concerns to avoid regulatory oversight or cost considerations is
less clear. Even in trials done in Western settings, it is now clear that
CRO-run psychotropic trials have included bogus patients.
Second, as mentioned above,
companies now control the production of the scientific literature. In the case
of drugs on patent, a significant proportion of the trials undertaken that do
not return the right result now remain unpublished, while a majority of those
published are in all probability ghost written and bear an ambiguous
relationship with their underlying data.
Third, a further problem
for scientific developments lies in the very methods put in place to control
the industry. Strapped into a supposed clinical trial straitjacket,
pharmaceutical companies found the new methods meant that barely beating
placebo would get a licence for all mood disorders or all psychoses or for
other conditions. Where once clinical trials had been a method to debunk the
claims of treatments that didn’t work or didn’t work reliably, they have since
become the fuel for the therapeutic bandwagons of treatments that are not
particularly effective—such as Prozac or Zyprexa.
Trials in which drugs
barely beat placebo on rating scale measures are read as evidence that drugs
“work,” when philosophically it would be more accurate to state that in fact
these trials offer evidence that it is simply not possible to say the drug does
nothing, but that most of whatever benefit there is stems from non-specific
factors. The emergence of trial results of this kind should, almost by
definition, have marked the point at which scientific investigation of the
drugs began, not the point at which independent scrutiny of the drugs in fact
finished. This should be the point where we ask if we can identify the small
number of patients who benefit specifically and move on to develop other
approaches for those who don’t.
But having received
marketing authorization on the basis of rating scale evidence that the drugs
“work” rather than on outcomes such as saved lives or return to work, there is
no incentive for companies to find treatments that have big effects on
particular syndromes. If the drugs “work,” surely it would be unethical for
clinicians not to use them for all cases of depression or schizophrenia!
Fourth, clinical practice
is increasingly constrained within guidelines issued by a variety of academic
or semi-regulatory bodies. Faced with escalating costs and public bewilderment
at variations in medical practice, the managers of medical services have turned
increasingly to guidelines. Companies have been aware of this for some time
and, through their control of the clinical trial and publication processes,
they now effectively control the guidelines governing large swaths of medical
practice. Although regulators have refused to endorse claims that newer agents,
from the antipsychotics and antidepressants through to the antihypertensives
are superior to older agents, even those guidelines drawn up by apparently
independent academics invariably endorse newer over older agents, making them
among the most powerful marketing tools that pharmaceutical companies have.[52]
Of course, guidelines state
that they are not law, but any commentary on whether one must adhere to them
makes it clear that any deviations without justification dramatically increase
the medico-legal risks of practice. The element of coercion may soon increase
with payments being linked to guideline adherence. It is not too fanciful to
see in this process a silencing of formerly independent physician voices by an una duce, una voce process.
Control of the scientific
literature and the clinical trial process has enabled drug companies to monger
diseases.[53] Disorders such as social phobia, panic disorder, and
depression have been sold in the expectation that sales would follow.
Epidemiological research that establishes how many people might potentially
meet criteria for particular conditions provides some of the most valuable data
for this disease mongering.
This selling of disorders
has gone hand in hand with a marketing of risk and fear. Early hints of
depression must be detected and treated in order to reduce the risks of
suicide, alcoholism, divorce, and career failure, and treatment must continue
to reduce the risk of relapse. Where treatment of a disease might mandate
treating one person per hundred, with treatment stopping once the condition
responds, treatment of those at risk of a disease or its consequences mandates
the treatment of one in ten, and has no natural stopping point.[54]
But there is more to disease
mongering than this. Company marketing is less and less about spreading
recognition of established disorders and increasingly about pathologizing
vicissitudes. A licence for Viagra, for instance, became a means for companies
to question young men with normal sex lives as to whether things couldn’t be
better. Any of life’s vicissitudes are now grist for the marketing mill, and
companies with a licence do not balk at changing our understanding of what it
means to be human, if it captures a niche for the product. There are no
academics drawing this to wider attention, perhaps because physicians in
general fail to understand where disease mongering comes from.
The Role
of Academics in the New Fascism
At the heart of these
developments is the failure of academics to understand modern marketing.
Despite regular surveys from marketing companies about the properties of a
desirable antidepressant or antipsychotic, and despite the participation of
clinical academics in opinion leader (focus) groups, clinicians confuse
marketing with the trinkets, free lunches, lecture fees, and trips to
conferences sponsored by company sales departments. They fail to see that they
are the source of the knowledge that goes into creating brands and fail to see
their role in virally transmitting new brands.[55] The actual differences between modern antidepressants
and modern antipsychotics are minimal; the perceived differences come almost
entirely from sophisticated consumer research aimed at understanding what
physicians might swallow.
In this process, academics
have three roles. First, as repositories of knowledge their role is to help
companies understand what the average clinician might perceive as a
development. Second as opinion leaders they help deliver the company message to
non-academic clinicians. Third, they lend their names to ornament the
authorship lines of journal articles and programs of academic meetings
reporting the results of the most recent company studies.
These academic meetings
have come to resemble political rallies, where the faithful assemble to hear
about the evils to be vanquished and the new methods to do so. It has been some
time since a trace of uncertainty entered into any of our major meetings, even
though we are living through a profound medical crisis in that the health of
our patients is worsening and beyond medicine there is debate about the
corruption of our science.[56] Yet the adverse effects of drugs are only aired if it
suits the marketing interests of one of the competing companies. Meanwhile
companies have commandeered most of our platforms and journal space to present
their products under the banner of science, while flouting the basic norms of
science—to make data publicly available.
Marketing of this sort does
a great deal to create the Healy, Olivieri, Blumsohn, Nissen, and Buse stories.
Because the marketing copy for drugs is derived from the most cherished notions
of academics and clinicians, rather than support colleagues grappling with the
pharmaceutical industry, clinicians perceive anyone who raises hazards of
treatment as attacking clinical care and the welfare of patients rather than
attacking the pharmaceutical industry, and these academics and clinicians react
accordingly, even if they have little or no connection to pharmaceutical companies.
What the Olivieri,
Blumsohn, and Healy stories suggest is that academia and health care have been
infected with an academic immune-deficiency virus (AIV). The defence reactions
that might have been expected from prestigious journals and professional bodies
in response to the virus seem to be paralyzed. Quite the contrary, the virus
seems to have been able to subvert normal defenses to its own purposes. These
defences have reacted almost as though it was their programmed duty to shield a
few fragile companies from the malignant attentions of a pharmacovigilante.
But just as everything was
crumbling behind the rhetoric of Stalinism, so also there is good evidence that
outcomes within both mental and physical health are deteriorating. Within
psychiatry, rates of hospital admission are rising and life expectancy for
patients with serious mental illness is declining [57]. What we are seeing within mental health is not what
happens when treatments work; it is not what happened to the dementia
paralytica (tertiary syphilis) services after the discovery of penicillin.
It is difficult to see our
professional organizations of clinicians, scientists, and academics being able
to take stock of the current situation and engage with the new corporate
campus. Our major journals and academic meetings have lost brand value.
Another way forward lies in
the recognition that drugs are not made in company laboratories— chemicals are.
In order for a drug to come into being, two things have to happen. First,
healthy volunteers and later patients in clinical trials agree to take these
chemicals to see what happens. Willingness to participate in these studies was
borne out of the global calamity of World War, when conditions of scarcity
mandated the development of the first controlled trials. We participated on the
basis that taking risks might injure us but would benefit a community that
included our friends, relatives, and children. We did so for free. At first
this worked and extended the compass of human freedom from the epidemics and
other scourges to which our ancestors had been subject for millennia.
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[1] D. Healy, “The Psychopharmacological Era: Notes toward a
history. J Psychopharmacology 4 (1990): 152–67; D. Healy, “The Marketing of
5HT: Anxiety or depression,” British J
Psychiatry 158 (1991): 737–42.
[2] D. Healy, The Antidepressant
Era (Cambridge, MA: Harvard
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[3] W. Creaney, I. Murray, D. Healy, “Antidepressant Induced Suicidal
Ideation,” Human Psychopharmacology 6
(1991): 329–32; D. Healy. “The Fluoxetine and Suicide Controversy.” CNS Drugs 1 (1994): 223–31; D. Healy, M.
Savage, “Reserpine Exhumed,” British J
Psychiatry 172 (1998): 376–8; D. Healy, C. Langmaak, M. Savage, “Suicide in
the Course of the Treatment of Depression,” J
Psychopharmacology 13 (1999): 94-99.
[4] D. Healy, Psychiatric Drugs
Explained, 5th ed. (Edinburgh: Churchill & Livingstone, 2008),
originally published (London: Mosby Yearbooks, 1993).
[5] D. Healy, Let Them Eat Prozac
(Toronto: James Lorimer, 2003).
[6] C. Elliott, introduction to Prozac
as a Way of Life, ed. C. Elliott and T. Chambers (Duke University Press,
2004. Durham North Carolina). The original articles were P. Kramer, “The
Valorization of Sadness: Alienation and melancholic temperament,” Hastings Center Report 30 (2000): 13-19;
C. Elliott, “Pursued by Happiness and Beaten Senseless: Prozac and the American
Dream,” Hastings Center Report 30
(2000): 7-12; D. DeGrazia, “Prozac, Enhancement and Self-creation,” Hastings Center Report 30 (2000): 34-40;
J.C. Edwards, “Passion, Activity and ‘The Care of the Self,’” Hastings Center Report 30 (2000): 31-33;
D. Healy, “Good Science or Good Business?” Hastings
Center Report 30 (2000): 19-22.
[7] Cited in C. Elliott (2004), introduction to Prozac as a Way of Life, ed. C. Elliott and T. Chambers (Duke
University Press, 2004, Durham North Carolina).
[8] D. Healy, “Antidepressant induced suicidality,” Primary Care Psychiatry 6 (2000): 23-28.
[9] A. McIlroy, “Prozac Critic sees U of T job revoked,” Globe and Mail, April 14, 2001.
[10] J. Coyne, “Healy’s study ‘odd,’” Bulletin (University of Toronto), July 23, 2001: 8.
[11] Http://www.healyprozac.com/AcademicStalking/default.htm.
[12] S. Ryder, letter to Robert J Temple,
Director, Office of Drug Evaluations, July 26, 2004, http://www.FDA.gov/ohms/dockets/ac/04/briefing/2004-406561-31-pfizer-letter.pdf,
24-25. (Accessed September 21, 2007).
[13] D. Healy, “Contra Pfizer,” Ethical
Human Psychology & Psychiatry 7 (2005): 181-195.
[14] J. Coyne, “Lessons in Conflict of Interest: The construction of the
martyrdom of David Healy and the dilemma of bioethics” American J of Bioethics 5 (2005): W3-W14.
[15] Http://www.ahrp.org/cms/content/view/18/87/ and http://www.healyprozac.com/AcademicStalking/default.htm.
[16] All correspondence on http://www.healyprozac.com/AcademicStalking/default.htm.
[17] All reviews and the covering letter are available from the author.
[18] Further documents can be found on http://www.healyprozac.com/AcademicStalking/default.htm.
[19] A. Fugh-Berman,
“Doctors Must Not Be Lapdogs to Drug Firms, BMJ
333 (2006): 1027.
[20] From profile of Peter Pitts on Drugwonks.com.
[21] From Drugwonks.com. Posting on September 6th 2007.
[22] From http://www.mslpr.com/, Accessed January 15, 2008.
[23] J. Thompson, P. Baird,
and J. Downie, The Olivieri Report
(Toronto: James Lorimer, 2001).
[24] A. Blumsohn, http://scientific-misconduct.blogspot.com/
(2006); A. Blumsohn, “Authorship, Ghost-science, Access to Data and Control of
the Pharmaceutical Scientific Literature: Who stands behind the word” Professional Ethics Report (American
Association for the Advancement of Science) XIX, no. 3 (2006),
http://www.aaas.org/spp/sfrl/per/per46.pdf.
[25] Http://finance.senate.gov/press/Bpress/2007press/prb111507a.pdf.
[26]C.M. Beasley, B.E. Dornseif, J.C.
Bosomworth, M.E. Sayler, A.H. Rampey, J.H. Heiligenstein, V.I. Thompson, D.J.
Murphy, and D.N. Massica, “Fluoxetine and Suicide: A meta-analysis of
controlled trials of treatment for depression,” BMJ 303 (1991): 685–92.
[27] I. Oswald, Letter, BMJ
303, (1991): 1058.
[28] All correspondence is available on http://www.healyprozac.com.
[29] D. Healy, Guest Editorial, “A Failure to Warn,” Int J Risk
Safety in Medicine 12 (1999):
151-56.
[30] D. Healy, “Antidepressant Induced Suicidality,” Primary Care
Psychiatry 6 (2000): 23-28.
[31] D. Healy, and D. Cattell, “The Interface Between Authorship,
Industry and Science in the Domain of Therapeutics,” British J Psychiatry
182 (2003): 22-27.
[32] H. Jick, J.A. Kaye, and S.S. Jick, “Antidepressants and the Risk of Suicidal Behaviours,” JAMA 292 (2004): 338-43.
[33] This data is also available on http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4065T2.pdf,
154.
[34] D. Fergusson, S. Doucette, K. Cranley-Glass, S. Shapiro, D. Healy,
P. Hebert, and B. Hutton, “The Association between Suicide Attempts and SSRIs:
A systematic review of 677 randomized controlled trials representing 85,470
participants. BMJ 330 (2005): 396-99.
[35] D. Healy. “Did Regulators Fail over Selective Serotonin Reuptake
Inhibitors?” BMJ 333 (2006): 92-95.
[36] See http://www.healthyskepticism.org/presentations/2007/Study329.ppt.
[37] M.D. Keller, N.D. Ryan, M. Strober, et
al. Efficacy of Paroxetine in the Treatment of
Adolescent Major Depression: A randomized, controlled trial,” J Am Acad
Child Adolesc Psychiatry 40 (2001): 762-72.
[38] Earlier versions of this paper and correspondence between the
company and medical writer, as well as letters to the journal, are available
from DH.
[39] Editorial, “Depressing Research,” Lancet 363 (2004): 1335.
[40] D. Healy,
“Our Censored Journals,” in ed. A.R. Singh and S.A. Singh, Medicine, Mental
Health, Science, Religion, and Well-being, MSM, 6, (Jan–Dec 2008) 244-256
[41] C. De Angelis, “The Influence of Money on Medical Science,” JAMA 296 (2006): 996-98.
[42] J. Carlson, ed., Banned in Ireland: Censorship and the Irish
writer (London: Routledge, 1990).
[43] J. Cornwell, The Power to
Harm: Mind, medicine and murder on trial (London: Penguin, 1996).
[44] J. Cornwell, Hitler’s Pope:
The Secret History of Pius X11 (London: Penguin, 1999).
[45] J. Cornwell, personal communication.
[46] The term brand fascism
was coined by Kal Applbaum, author of The
Marketing Era. See note 55.
[47] D. Healy, Mania: A short
history of bipolar disorder (Baltimore: Johns Hopkins University Press,
2008.)
[48] United States Patent 4,988,731. Date of Patent Jan 29, 1991; United
States Patent 5,212,326. Date of Patent May 18, 1993.
[49] United States Patent
5,229,382. Date of Patent May 22, 1992. European patent, EP0,454,436, filed on
April 24, 1991.
[50] Memo from Leigh Thompson, February 7, 1990. Exhibit 98 in Forsyth vs. Eli Lilly, cited in Healy, Let Them Eat Prozac, chapter 11.
[51] Zyprexa Multidistrict Litigation 1596, Bates page ZY201548772, July
25, 2001.
[52] D. Healy, Trussed in
Evidence? Ambiguities at the Interface of Clinical Evidence and Clinical
Practice Transcultural Psychiatry 2009,
46, 16-37.
[53] R. Moynihan and A.
Cassels, Selling Sickness (New York:
Nation Books, 2005).
[54] I. Heath, “Combating
Disease Mongering: Daunting but nonetheless essential,” PLoS Medicine 3 (2006): e146.
[55] K. Applbaum, The Marketing Era. (New York: Routledge,
2004).
[56] M. Angell, The Truth about the Drug Companies. How they
deceive us and what to do about it (New York: Random House, 2005); J.
Kassirer, On the Take. How medicine’s
complicity with big business can endanger your health. (New York: Oxford
University Press,2005).
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