Strattera Deaths (German TV Request) False Reports from Eli Lilly

Wed Nov 12, 2008

We have received a request from a German TV crew who is doing a special on Lilly’s newer ADHD medication, Stratera. These investigative reporters from Germany are doing a 45 minute piece and looking for experiences of tragedy /suicide or severe adverse reactions in children treated for ADHD with this drug. I know we have had reports, but I do not keep close track anymore of which drug is involved after so many cases because all these drugs work basically the same way. An antidepressant is an antidepressant no matter what you callmit or what you prescribe it for or how you explain its supposed uniqueness. So if you or someone you know has been through a Strattera-induced nightmareand would be willing to help get some exposure of this in the press, please get in touch with me so that I can put you in touch the reporters.

O nce you read the following article on Strattera deaths you will see how very important it is to get information about this drug out to the public –

especially throughout the UK and Europe. What is going on here IS CRIMINAL!!
And here is just one example out of the article below that is full of data on how
the government agency in the UK who oversees these drugs is ignoring
critical information – even fatalities, and doing NOTHING but making excuses
for their own behavior:

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing “œpsychomotor hyperactivity. Lilly called
this an exacerbation of the “œunderlying ADHD”. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done not even from the manufacturer.

Do read the rest of the information because it is clearly eye opening!! This
newer ADHD drug, Strattera, which is really an SSRI antidepressant, is
getting away with murder right under everyone’s noses. So definitely if you
know someone who is willing to talk to this news crew about their experience with
this drug, please do let me know ASAP.

Thank you,

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (https://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_
medicines_agency_refuses_to_act.htm#_
(http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
dicines_agency_refuses_to_act.htm#
)

October 20, 2008
_Print this article_
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dicines_agency_refuses_to_act.htm#
)

Strattera adverse effects: UK Medicines Agency refuses to act
By Sepp Hasslberger

Categories
_Pharma_ (http://www.newmediaexplorer.org/sepp/pharma.htm)

Janne Larsson, an investigator and reporter in Sweden, has obtained
information about adverse event reports on Eli Lilly’s ADHD drug Strattera,
using the Swedish freedom of information laws. The data, coming from both the FDA’s
adverse reaction database and from reports to the UK’s Medicines agency, shows
numerous adverse effects and scores of deaths by suicide.

Yet the agency, even after repeated prodding by Larsson to initiate action,
has refused to budge or even acknowledge that there is a problem. MHRA
apparently accepts the drug’s producer Eli Lilly’s data rather than its own and
the
FDA’s adverse event reports.

Image credit: _Monheit Law_
(http://www.monheit.com/strattera/contact_lawyer.asp)

Larsson says: An investigation of MHRA™s handling of the harmful effects of
the ADHD drug Strattera has proven the following:

MHRA has ignored data about instances of death among children in connection
with Strattera treatment. At least 41 children have died. The agency has not
investigated the reported cases and does not even have a compiled summary of
cases with fatal outcome. Further the agency has allowed the manufacturer Eli
Lilly to give false information about the number of fatal cases and has
taken no action against the company once the false information was revealed.

MHRA has for almost three years been in possession of data proving that
Strattera can cause agitation, mania and psychotic reactions with hallucinations
among children. Yet no warning has been issued to doctors and parents. The
agency has withheld these disastrous consequences despite clear evidence. Due
to bureaucratic procedures no warnings have been issued even if Eli Lilly reluc
tanly conceded to include these harmful reactions in its information to the
public almost a year ago.

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing œpsychomotor hyperactivity. Lilly called
this an exacerbation of the œunderlying ADHD. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done“ not even from the manufacturer.
The background data for these conclusions can be found in the following text
and in the linked documents. When reading the data below please remember the
promise from the MHRA: we take any necessary action to protect the public
promptly if there is a problem._MHRA, About us_
(http://www.mhra.gov.uk/Aboutus/index.htm) [1]

Note that the linked documents (within letters described below) in most
cases could not be obtained in UK where the issuance of them would be deemed as
prejudicing œthe ability of the Assessory body to offer impartial advice and
where the MHRA wants to allow marketing authorisation holders the chance to
respond to regulatory action and make commercial decisions before data are
in the public domain. (MHRA, e-mail about FOIA-request, 29th September,
2006). However the documents could be obtained in Sweden, even if the MHRA has
tried to stop the issuance of them by implying that publication could threaten
the relations between Sweden and UK.
Deaths among children in connection with Strattera treatment

In May I submitted detailed data about cases of Strattera death to the MHRA.
1st October I finally got an answer from the Scientific Assessor of the
Vigilance and Risk Management of Medicines (VRMM). 7th October I got an answer
from Professor Kent Woods, CEO of the MHRA, referring to the letter sent by the
Scientific Assessor.

My data about Strattera deaths can be found _in the letter_
(http://jannel.se/Strattera.death2.pdf) Strattera: Eli Lilly gave false
information about
deaths from Strattera treatment “ a request for full investigation from 15th
May. [2]
The answer from the Scientific Assessor shows that MHRA is continuing to
ignore data about instances of death among children and adults in connection
with Strattera treatment. Despite limited resources and having to rely on data
released by reluctant medical agencies I had been able to produce a summary of
reported cases of Strattera death. Thats much more than the MHRA, with its
immense resources, had been able to do.

The agency was provided with specific data about instances of death forming
an excellent starting point for a full investigation. But instead of using
the data the MHRA used its energy to explain why it is impossible to
investigate these cases further, and in doing so presents some remarkable
comments.

The Scientific Assessor states _in the letter 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3]:

in order to calculate the total number of reports with a fatal outcome
it is not simply a case of adding up reports with a fatal outcome mentioned
in our assessment reports of the PSURs [Periodic Safety Update Reports] and
those available on the FDA website as these different sources may contain
duplicate information. [Emphasis added.]

I fully agree and it takes only a casual reading of my letter from 15th May
to find out that much care has been taken to exclude possible duplicates. It
is quite easy to see that the data presented about fatal cases in my letter
is NOT simply a case of adding up reports with a fatal outcome. The only
way to come to another conclusion would be not to look in the first place and
it is a condemnation of the effectiveness of the agency to state the following
in the letter:

We have looked at the data you have sent us to see if they can add insight
to the statutory sources of data we have received and do not think that they
are of benefit as we cannot verify their source or accuracy. (p. 3)
[Emphasis added.]

I must add to all the data provided in my letter 15th May that the our

of the information about fatal cases is FDA™s Medwatch system and the PSURs
(submitted directly to the MHRA). I must make it clear that is very easy for
a lay person to find out that almost all reports about fatal outcome from
Strattera treatment submitted to the FDA came from Eli Lilly!

Thus the our of the information about fatal cases was in most of the
cases the manufacturer itself“ Eli Lilly. And yet the MHRA has not been able
to verify the source or accuracy of the information. The MHRA Scientific
Assessor states in the letter:The sources of data that regulators use such
as company data, spontaneous adverse reaction reports and literature are set
out in European and national law.
My FOIA request earlier this year to get a compilation of fatal cases in
connection with Strattera treatment was answered 12th August:

Thats very good and now we know that the data I submitted to the MHRA about
all fatal cases from Strattera treatment “ in the absolute majority of cases
were known by and reported via the manufacturer Eli Lilly.
The MHRA holds no data other than that previously released to you [the
misleading data from Eli Lilly in November 2007, see my letter from 15th May
for
more data] which was the data provided by the company. If you have any
questions about FDA data or the data provided by the company, you should
contact those organisations.

In other words the MHRA didn’t have a compiled summary of cases with fatal
outcome in August and the agency has not to this point been able to compile
such a summary.

As the agency has not been capable of getting the data or not even been
capable of using the specific data submitted for its use in a full
investigation NO action is taken despite the many verified deaths among
children in connection with Strattera treatment. This disregard for the safety of children is a scandal which should lead to a full formal investigation by the
Department of Health.

Drug induced agitation, mania and psychosis with hallucinations

Ive been contacted by parents asking if Strattera can induce mania and
psychosis with hallucinations. Their children have had such symptoms. The
parents have not found any warnings about it and their childrens doctors don’t
think that the symptoms are caused by the drug. The parents were desperate.

However the MHRA has known for almost three years that Strattera can cause
agitation, mania and psychotic reactions with hallucinations among children,
but has refused to issue warnings about it.

The Scientific Assessor from the MHRA _in the letter of 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3] now confirms my
earlier arguments that the agency had knowledge about these effects a long time ago:

following an initial request in the assessment report for the Periodic
Safety Update for the period (dates 27-05-2005 to 26-11-2005) we asked Eli
Lilly for more information to enable us to review this issue in more detail. (p. 2)

This means that in the period ending 26th November, 2005 at the time when
Strattera was approved only in UK and four other European countries, but not
in the 22 additional European countries where it is now approved Eli Lilly
and the MHRA had knowledge about these disastrous effects in children taking
Strattera. But neither the MHRA nor Eli Lilly told anything about it and
Strattera was approved in 20 additional European countries in April 2006.
Image credit: _Wikimedia Commons_
(http://commons.wikimedia.org/wiki/Image:Strattera_atomoxetin.jpg)

Professor Kent Woods, CEO of the MHRA seems to be very misinformed by his
staff when answering about Strattera in a recent _letter of 7th October, 2008_
(http://jannel.se/answer.kent.woods.pdf) . In the letter Professor Woods
states [4]:

The MHRA is committed to ensuring that all safety concerns are subject to
robust scientific assessment and the best possible regulatory action is taken
in a timely manner. We strive to maintain the highest standards of work and
review our practices to ensure these standards are maintained or improved
upon where necessary. (p. 1)

In their 3rd March, 2006 report Psychiatric Adverse Events Associated with
Drug Treatment of ADHD: Review of Postmarketing Safety Data [5], the FDA
stated that there was compelling evidence for a likely causal association
between [Strattera/amphetamine drugs] and treatment emergent onset of signs and/or
symptoms of psychosis or mania, notably hallucinations, in some patients.

(p. 17) 360 reports about the drug inducing these effects had been received
up to June 2005.

From this FDA report the MHRA had knowledge about the œcompelling evidence for Strattera causing these effects on or about 3rd March, 2006 but did nothing.

In August the same year (2006) the MHRA requested the same data set from Eli
Lilly that was submitted to the FDA and which formed the basis of the FDA
report for Strattera. The data was sent to the MHRA some days later. But the
agency then decided not to do anything with the information. Instead it was
decided that Eli Lilly the manufacturer should do an analysis of the data
and submit its conclusions to the agency.

Professor Kent Woods says in his letter: An important aspect to this [ robust scientific assessment, highest standards] is ensuring that data from all available sources have been consider This may be true in some other area but it is definitely not true for the
safety work around Strattera. A very good example of this is the complete
rejection of the robust scientific assessment of Strattera in the FDA report.
Answering the question why the agency did not use the compelling evidence for harm in the FDA report _an official at the MHRA declared in a letter_
(http://jannel.se/mhraanswer.pdf) [6]:

Changes to European product information are based on assessment by EU
regulators, agreement between member states and in line with legal requirements
about product information, not on conclusions of FDA assessors. (25th May,
2007) [Emphasis added.]

Responsible officials at the MHRA had instead decided to rely completely on
the analysis of the manufacturer of the drug Eli Lilly. (In an article in
the Daily Mail this summer, Andrew Herxheimer, editor of the Drug and
Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre commented:
Asking a drug company to review its own product is crazy, but it goes on quite a lot.
) [7]

At the end of 2007/beginning 2008 Eli Lilly submitted its review of
Strattera induced agitation, mania and psychosis with hallucinations to the
MHRA. It was a complete whitewash.

In summary: FDA was very clear about the psychosis-inducing effects of
Strattera; the MHRA did not listen. Instead the MHRA turned to the
manufacturer. Eli Lilly tried to explain away all the bad results found in its review. For
the full history about MHRA’s failure in this area and for a comparison of
the FDA report with the Lilly report, please see the following letter: _The
ADHD drug Strattera“ actions needed now_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] from January 2008, and
the letter _The ADHD drug Strattera“
an analysis of reports of drug induced mania, psychosis and hallucinations_
(http://jannel.se/strattera.mhra.March.08.pdf) [9] from March 2008.

In the letter from March [9] Eli Lilly’s whitewash report for the period up
to November 2007 is presented. At the end of that report Lilly says [10]:

Nevertheless, Lilly will consider adding language regarding psychotic symptoms
including hallucinations to its product information sheet. (p. 1279)

Larsson – _Suicides & Psychiatric Drugs_
(http://www.newmediaexplorer.org/sepp/suicide.psychiatricdrugs.pdf)

And so we come to October 2008 and the letters from Professor Kent Woods and
from the Scientific Assessor for Strattera. We are reassured that the MHRA
is acting to ensure that Strattera is used as safely as possible that

all safety concerns are subject to robust scientific assessment and the best
possible regulatory action, that any new safety signals are evaluated in
an independent, scientifically robust manner (Woods); we are told that

discussions between European Member States and Eli Lilly are ongoing to agree
on the most appropriate information to be included in the product information
for patients and prescribers; we are told to be patient, to understand that
it takes time from the point where œupdates have been agreed for inclusion in
the product information to the point where these will appear in the packs
in the market place due to movement of stock in the supply chain, and that
the appearances are estimated to be within the next 6 months (Scientific
Assessor).

It is probably hard to find a more obvious violation of the promise¦ we
take any necessary action to protect the public promptly if there is a
problem than the case described above. The worried parents still have no answers if
Strattera can induce the symptoms they find in their children. And the MHRA
knew about it three years ago but withheld the data. This should be
included in the investigation of the agency by the Department of Health.

Strattera causing hyperactivity“ the condition it was supposed to alleviate In my earlier letter to the Department of Health (29th August) I took up the data about the 700 forgotten cases of hyperactivity. I referred to my _letter 2nd January to the MHRA_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] and gave data about the
fact that Eli Lilly had withheld sensitive information and classified harmful effects as an exacerbation of the underlying ADHD.

The logical solution would have been for the MHRA to request all data about
this security risk, followed by an independent review of the data. But this
was not done and as expected nothing is still done. MHRA asked Lilly for an
explanation about this signal stemming from Periodic Safety Update Report
5 (dates 27-05-2005 to 26-11-2005) but got no answer. Three years later the
Scientific Assessor from the MHRA writes in the letter from 1st October:

The information submitted by the MAH [Market Authorization Holder] has been
evaluated and the MAH will be requested to provide further detailed
information within the next 2 months to ensure the issue has been investigated
in a thorough and scientific manner. (p. 2) [3]

The MHRA got this safety signal almost three years ago and is still in
the process of getting some sensible answers from Eli Lilly.

————

I again request the Department of Health to take action. This does not
concern only the children in UK; it concerns the children in the whole of
Europe, indeed it concerns all the children of the world.

The failure of the agency will also mean that psychiatrists within The
Guideline Development Group in NICE can push through more treatment with
Strattera and other ADHD drugs. The MHRA is withholding the clear evidence for
harmful effects and the psychiatrists with close relations to the manufacturers
of the drugs can unimpeded recommend these medicines to unsuspecting
doctors and parents.

The answers given by Professor Kent Woods and the Scientific Assessor did
not in any way handle my concerns. On the contrary, they finally proved that a
full formal investigation of the matters raised above is needed.

Yours sincerely,

Janne Larsson

Reporter – investigating psychiatry
Sweden
_janne.olov.larsson@…_ (mailto:janne.olov.larsson@…)

[1] MHRA, About us, _http://www.mhra.gov.uk_ (http://www.mhra.gov.uk/)
[2] Larsson, Strattera: Eli Lilly gave false information about deaths from
Strattera treatment“ a request for full investigation, May 15, 2008,
_http://jannel.se/Strattera.death2.pdf_ (http://jannel.se/Strattera.death2.pdf)
[3] MHRA, Re: letter of 9th September 2008 to “Assessor responsible for
Strattera, October 1, 2008,
_http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf)
[4] MHRA, Re: Open letter to Pr. Kent Woods (10th August 2008), October 7,
2008
_http://jannel.se/answer.kent.woods.pdf_
(http://jannel.se/answer.kent.woods.pdf)
[5] FDA, Psychiatric Adverse Events Associated with Drug Treatment of ADHD:
Review of Postmarketing Safety Data, released March 3, 2006.
_http://www.fda.gov/ohrms/dockets_
(http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4210b_11_01_AdverseEvents.\
pdf
)
[6] MHRA, answer FOI request, May 25, 2007,
_http://jannel.se/mhraanswer.pdf_ (http://jannel.se/mhraanswer.pdf)
[7] Daily Mail, Heart attacks and suicides… yet the dangers were all kept
so quiet. So how CAN you trust your medicine? July 7, 2008,
_http://www.dailymail.co.uk/_
(http://www.dailymail.co.uk/health/article-1033132/Side-effects-include-suicide-\
heart-attacks-So-prescribed-drugs.html
)
[8] Larsson, The ADHD drug Strattera – actions needed now, January 2, 2008,
_http://jannel.se/letter.mhra.strattera.jan08.pdf_
(http://jannel.se/letter.mhra.strattera.jan08.pdf)
[9] Larsson, The ADHD drug Strattera – an analysis of reports of drug
induced mania, psychosis and hallucinations, March 9, 2008,
_http://jannel.se/strattera.mhra.March.08.pdf_
(http://jannel.se/strattera.mhra.March.08.pdf)
[10] Eli Lilly, Cumulative review of Spontaneous Case Reports of Mania,
Psychotic Disorders, Hallucinations, and Agitation, Appendix 16 to Periodic
Safety Report 9 for Strattera, 2008,
_http://jannel.se/Lilly_psychosis_strattera.pdf_
(http://jannel.se/Lilly_psychosis_strattera.pdf)

See also:

_Doctors told to curb use of Ritalin in hyperactive children_
(http://www.timesonline.co.uk/tol/news/uk/science/article4813727.ece)
_Children’s suicide attempts raise concerns about ADHD medication_
(http://www.theglobeandmail.com/servlet/story/RTGAM.20080703.wadhd03/BNStory/spe\
cialScie

nceandHealth/home)
_The ADHD drug Strattera: Lilly to issue warnings about psychosis,
hallucinations, mania and agitation_ (http://jannel.se/strattera.psychosis.doc)
_Strattera side effects_ (http://www.bonkersinstitute.org/stratteraffex.html)

_Strattera – 10,988 adverse “psychiatric reactions” reported in less than
three years_ (http://www.24-7pressrelease.com/view_press_release.php?rID=16662)
_Attention Deficit Hyperactivity Disorder? No, they’re just naughty, say
experts_
(http://www.dailymail.co.uk/news/article-1031436/Attention-Deficit-Hyperactivity\
-Disorder-No-theyre-just-naughty-say-experts.html#
)

1,226 total views, no views today

4/17/2001 – Snub to Prozac critic upsets teachers

http://www.globeandmail.com

Snub to Prozac critic upsets teachers

Faculty group sees academic freedom
at risk in U of T withdrawal of job offer

ANNE McILROY
SCIENCE REPORTER
Monday, April 16, 2001

The Canadian Association of University Teachers says it is disturbed by the
University of Toronto’s decision to revoke the job offer it made to an
internationally recognized psychiatrist after he criticized a drug company.

“It appears that there has been a very serious violation of academic freedom
at the University of Toronto that requires remedy,” James Turk, executive
director of the association, said in a letter to U of T president Robert
Birgeneau.

The U of T and the Centre for Addiction and Mental Health, an affiliated
teaching hospital, had been courting Dr. David Healy since July of 1999. He
is an expert in drugs and psychiatry at the University of Wales.

They made him a formal, written offer of a combined faculty and clinical
position in May of 2000, and sent a more detailed letter in August. The U of
T hired a lawyer to help him immigrate.

Then, on Nov. 30, 2000, Dr. Healy gave a lecture at the CAMH in which he
criticized drug companies for avoiding experiments that may show there are
problems with their drugs, and for not publishing unfavourable results. He
said the data show that Prozac, manufactured by Eli Lilly and Co., may cause
suicide in some people.

Eli Lilly is the “lead” donor to the CAMH, according to its Web site, and has
contributed more than $1-million to the centre’s $10-million capital
campaign. It argues Prozac is safe.

Last year, Eli Lilly cancelled its $25,000 (U.S.) annual donation to the
Hastings Center in New York, a think tank that looks at ethical issues, after
it published a series of articles about Prozac, including a critical one by
Dr. Healy.

“There are good grounds to believe that Prozac can trigger suicidality. The
pharmaceutical companies are not investigating, however; one wonders whether
they are receiving legal advice echoing that given to the tobacco companies,
that any investigation of these issues may increase product liability,” Dr.
Healy wrote.

Eli Lilly says it withdrew funding because the Hastings Center published
“articles which Lilly felt contained information that was biased and
scientifically unfounded, and that may have led to significant misinformation
to readers, patients and the community,” said Laurel Swartz, manager of
corporate communications for Eli Lilly.

A week after Dr. Healy’s speech, Dr. David Goldbloom, physician-in-chief at
the CAMH and a professor at the U of T, rescinded his job offer.

The CAMH says the decision was made on the basis of a number of factors it
can’t make public. Eli Lilly says it played no role.

Mr. Turk has asked for a meeting with the U of T president to discuss what
happened.

David Naylor, dean of the University of Toronto’s faculty of medicine, says
it is not the U of T’s role to launch an inquiry.

The eight hospitals affiliated with the U of T are responsible for their own
human-resources decisions, he said. In the case of Dr. Healy, the CAMH would
have been the primary employer, not the U of T.

Yet it was the U of T vice-provost who sent Dr. Healy a memo confirming his
offer of employment and informing him that a lawyer had been hired to help
him immigrate.

While saying that the Dr. Healy affair is strictly in the domain of the CAMH,
Dr. Naylor acknowledges that he did make inquiries about what happened.

“I don’t believe there is any particular conspiracy, conflict of interest or
any malice here. In fact, I am satisfied there is not.”

1,376 total views, no views today

4/07/2001 – Insight Mag – Misleading Medicine

Once again Kelly O’Meara has written an incredible article. This time the
subject is the absurdity of the PMDD diagnosis and the prescribing of Prozac
repacked and renamed as “Sarafem” for that “disorder.” We have included the
first several paragraphs for you and encourage you to go to the Insight
Magazine sight to read the rest.

The article gives much insight into the lengths to which Lilly will go to
cover up the fact that Prozac and Sarafem are one in the same drug.
Apparently as long as they do not admit it publicly it is not reality?

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
http://insightmag.com/archive/200104301.shtml

InsightMag.com
——————————————————————————
Misleading Medicine
——————————————————————————
By Kelly Patricia OMeara
komeara@…
——————————————————————————

Pharmaceutical giant Eli Lilly is promoting Sarafem as a miracle pill for
women suffering from PMDD, a mental disorder not yet proved to exist.
Whats more, Eli Lilly admits that Sarafem has the same active ingredient as
Prozac, complete with the same dangerous side effects.

Australian-born singer Helen Reddys 1972 hit song I Am Woman has been
called a feminist battle hymn. Many a male disc jockey at the time refused to
air it until the song became part of the soundtrack to a movie and catapulted
to the top of the Billboard charts. Taking a look at the song today, its
hard to imagine the furor generated by the lyrics from the lady down under:
Oh, yes, I am wise, but its wisdom born of pain.
Yes, Ive paid the price, but look how much I gained.
If I have to I can do anything.
I am strong. I am invincible. I am woman.
Nearly three decades since the release of this feminist anthem the
lyrics neither threaten nor offend if they ever did but seem to
acknowledge pride in feminine strength. As if it needed to be said,
historians agree on the significance of women in the building of this nation.
The Jamestown settlement, for instance, was a disaster and on the brink of
failure until women were added to the new colony. The West was won by men and
women working side by side, and the United States triumphed over its enemies
in World War II with the help of nearly 500,000 women in the ranks and
millions more in the factories.
Not surprisingly, women achieved these feats completely unaware that a
few days out of each month they were suffering from a mental disorder. Thats
right. The Food and Drug Administration (FDA) recently approved the use of
Sarafem (fluoxetine) for women suffering from a mental disorder just three or
four days a month in the luteal phase or just before the onset of
menses.
This mental disorder which the American Psychiatric Association
(APA) has not yet accepted, but which is listed in the appendix of the APAs
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) is called
premenstrual dysphoric disorder, or PMDD. Its a new-and-improved version of
premenstrual syndrome (PMS), which also has not made it to the hit parade of
the official APA list of mental illnesses. The fact that PMDD is listed only
in the diagnostic manuals appendix reflects the APAs desire for further
research before accepting it as a full-fledged mental disorder.
According to the DSM-IV and the FDA, a woman must experience five or
more symptoms before the diagnosis can be made. The unofficial mental
disorder is said to be characterized by the following symptoms:

Markedly depressed mood

Marked anxiety

Marked affectivity

Decreased interest in activities

Feeling sad, hopeless or self-deprecating

Feeling tense, anxious or on edge

Persistent irritability, anger and increased interpersonal conflicts

Feeling fatigued, lethargic or lacking in energy

Marked changes in appetite

A subjective feeling of being overwhelmed or out of control

Physical symptoms such as breast tenderness, swelling or bloating.

Eli Lilly and Co., the Indianapolis-based pharmaceutical company that
makes Sarafem, has been marketing the new treatment with such gusto that
there are jokes about the company exhibiting obsessive-compulsive disorder.
It seems there isnt a magazine to be picked up or a channel to be surfed
that isnt running a Sarafem advertisement.
These ads show women expressing many things. One TV spot depicts a
woman trying to button her slacks and looking angry and agitated. Another
scene shows a woman snapping at her husband, Just leave me alone, while
still another involves a woman slumped on the couch sobbing. Then there is
the slogan: Sarafem More like the woman you are.
Lilly reports in its ads that now, Doctors can treat PMDD with
Sarafem the first and only prescription medication for PMDD. The ad
further states that, Sarafem contains fluoxetine hydrochloride, the same
active ingredient found in Prozac. But both Sarafem and Prozac are
fluoxetine hydrochloride. According to Laura Miller, marketing associate for
Eli Lilly, Fluoxetine hydrochloride is the same active ingredient in Sarafem
as in Prozac. Again and again Insight asked, Then is it the same thing?
Again and again Miller only repeated that the two identical doses of
fluoxetine hydrochloride have the same active ingredient.
Miller refused to acknowledge that Sarafem is just Prozac repackaged,
or that the pill color was changed from green to feminine pink and lavender
to market it for a not-yet-approved mental disorder that never before
existed. The Lilly representative did say the difference in the treatments is
in how women react to the drug.
Never mind that all this dramatic hype, supported by millions of
dollars in marketing, has occurred just before Lilly loses its exclusivity on
Prozac in August. . . . to finish article go to:

http://insightmag.com/archive/200104301.shtml

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3/30/2001 – LSD to Prozac and back to LSD?!

In the last half century we have witnessed Eli Lilly bring America LSD and
then Prozac. Now that the public has been brainwashed about the “benefits” of
Prozac and its clones, it is time to once again attempt to sell us on LSD.
After admitting in this article the truth of the argument I have made for ten
years against the SSRI antidepressants – they work like LSD in the brain (”
Nichols says there is some indication these drugs work on the serotonin
pathway in the brain, the same target of the selective serotonin reuptake
inhibitor drugs Prozac, Paxil and Zoloft, used to treat depression, anxiety
and obsessive compulsive disorder.”) they now work to sell us on the
“benefits” of LSD. After all, if we can as a society have given similar drugs
– the SSRIs – such a warm welcome, we must now be ready to accept LSD, the
CIA’s drug of choice for a mind control experimentation, with welcome arms as
well.

Has the world gone completely mad?! Obviously! We now have the National
Institute on Drug Abuse encouraging us to use a drug, already declared
dangerous and of no medical use, when they are suppose to educate us on the
dangers of it. Perhaps the name of the institute should be changed to the
National Institute for Production of Drug Abuse. At this point it would
certainly be more appropriate. Clearly they are counting on their lack of
educating the public about drugs to have produced enough public ignorance of
drugs and their effects so as to allow them to get away with this one. As I
have said repeatedly, the drug companies count on our memory loss. They
expect us to forget within a generation our experience with a drug and then
pull the same drug on us again. They generally give it a new name, or a new
twist, but the more you learn about drugs, the more you realize that the
drugs remain the same.

Obviously on this one they are counting on mass stupidity among the general
population for its acceptance. I would hope that everyone of you is working
as hard as you can to educate all around you to the dangers of these drugs.
Time is of the essence! If you have not yet figured out that we are in a
battle for our lives, you have missed something. Our society as we have known
it and our future is at stake. The Brave New World is here. And with them
feeling so confident as to take such a bold and blatant step as this all that
can be said at this point is, “God help us all!”

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://abcnews.go.com/sections/living/DailyNews/hallucinogen010322.html

A computer-generated model of the LSD molecule. (Heffter Institute)

MedicalHallucinogens?

Researchers Studying Possible Medical Use of LSD, Peyote, Psilocybin

By Robin Eisner

N E W Y O R K, March 22 Could shrooms or LSD help the mentally ill?

STORY HIGHLIGHTS
Hallucinogens Among Oldest Drugs
Trials Must Be Rigorously Designed
Critics: Risks Outweigh Benefits

At Harvard, a psychiatrist is studying whether the hallucinogenic cactus
peyote creates any long-term memory or attention problems in the American
Indians who take the drug as part of religious rituals.

A University of Arizona psychiatrist is poised to begin researching whether
taking the hallucinogen psilocybin under controlled circumstances may help
people suffering with obsessive compulsive disorder.

And another Harvard psychiatrist is in the beginning phases of designing a
protocol that may employ LSD or another hallucinogen to see if it helps
terminally ill people suffering from depression and pain.

With some support from the private New Mexico-based Heffter Institute, these
researchers, along with others in the United States and abroad, represent a
small movement of scientists looking at the possible medical benefits of
hallucinogens for some psychiatric conditions.

Hallucinogens Among Oldest Drugs

Hallucinogens are among the oldest known group of drugs that have been used
for their ability to alter human perception and mood, according to the Drug
Enforcement Agency. They have been used for medical, social and religious
practices.

More recently, synthetic hallucinogens have been used recreationally, with
hippies from the ’60s, such as the now deceased ex-Harvard psychology
professor Timothy Leary, first promoting their use with the famous slogan,
Turn on, Tune in, Drop Out.

Today, hallucinogens are deemed drugs of abuse by the DEA, with no known
medical benefit. Approximately 8 percent to 10 percent of high school
seniors tried a hallucinogen in the past year according to a University of
Michigan study of drug use.

It remains unclear how these drugs exert their action in the brain, but
anecdotal evidence and some earlier studies indicate they may help a variety
of psychiatric conditions, says David E. Nichols, founder of the Heffter
Institute, in Santa Fe, and professor of medical chemistry and molecular
pharmacology at Purdue School of Pharmacy in West Lafayette, Ind.

Nichols says there is some indication these drugs work on the serotonin
pathway in the brain, the same target of the selective serotonin reuptake
inhibitor drugs Prozac, Paxil and Zoloft, used to treat depression, anxiety
and obsessive compulsive disorder.

He founded the institute in 1993 to help give scientific credibility to
medical research on hallucinogens. After years of fund-raising, the
institute now has enough money to help scientists do serious research.

Trials Must Be Rigorously Designed

Since opinions are so strongly held about hallucinogens, it is essential
that any studies in this area be performed with the most rigorous modern
methods and great care to have an impartial approach, says Dr. Harrison
Pope, professor of psychiatry at Harvard Medical School, who is leading the
four-year peyote study in American Indians.

Funded largely by the National Institute of Drug Abuse and Heffter, Popes
group will be comparing three populations of American Indians peyote users
in religious ceremonies, alcoholics, and local tribespeople to see if
peyote use is associated with cognitive problems.

Pope is also developing a trial to follow up on studies from the ’60s and
’70s suggesting that hallucinogens helped ease anxiety and depression in the
terminally ill and also reduced their need for pain medication.

The challenge is to design the study in such a way that if the drug shows
benefits, skeptics are convinced, and if it doesnt help, proponents of
hallucinogenic use dont challenge the research as inadequate, Pope says.

Psilocybin mushroom

These studies take time to develop to get that scientific imprimatur. They
also need to get review, by local medical institutions and governmental
regulatory authorities. The DEA and the FDA is still reviewing a protocol by
Dr. Francisco Moreno, an assistant professor of psychiatry at the University
of Arizona in Tucson, hoping to study a chemically synthesized psilocybin
for obsessive-compulsives. His hospital gave him permission to start the
study.

A protocol of psilocybin and depression in Switzerland also is undergoing
revision before it is submitted to the government authorities there, Nichols
says.

Critics: Risks Outweigh Benefits

Some scientists, however, question the potential risks of these studies.

The problem with this kind of research is that when average people hear or
read about them in this preliminary stage they might think these drugs could
be good for them now, says Una McCann, associate professor of psychiatry at
Johns Hopkins School of Medicine. But it remains unknown until the studies
are finished, McCann says.

Dr. Gregory Collins the director of the Alcohol and Drug Recovery program at
the Cleveland Clinic, in Cleveland, Ohio, believes the risks outweigh any
benefits.

Some of these drugs have been shown to have long-term consequences in
healthy people, Collins says. I would be reluctant to try them in the
mentally ill.

Nichols, however, defends the research. I think we will find some medical
benefit of these drugs, Nichols says. There is no other drug class that
doesnt have some medical utility.

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3/13/2001 – March Edition of drugawareness.org now online.

The March edition of the ICFDA www.drugawareness.org site is
now on line. So much has been happening lately, that’s it’s been
difficult to keep up with all the news. But, please take a look
when you can. There are just a sampling of some very important
stories that are posted there.
——-
1/22/01 Doctors and Patients Don’t Talk About Antidepressant
Side Effects
By Carla Cantor, CBS HEALTH WATCH

A new public health survey reveals that nearly half of the people
being treated with antidepressants experience side effects and
55% of those patients stop taking their medication, rather than
talk to their doctors about the issue.

2/19/01 Prescriptions: How your doctor makes the choice
By Joseph P. Shapiro and Stacey Schultz [US NEWS]

Three years ago, doctors at the Everett Clinic in Washington
State took a hard look at the stream of pharmaceutical sales
reps filing into their offices. “Enough!” they said. Then they
closed their doors on the cheery “detailers” who vied for their
attention each day, lugging suitcases of free drug samples.
Medical director Al Fisk, who masterminded the move,
suspected that the samples were skewing his doctors’ drug
choices toward the most heavily promoted drugs–even when
less expensive ones were just as effective. “There’s a reason
why the pharmaceutical business spends [billions] on physician
detailing,” he says. “It’s easy to influence prescribing habits.”

2/24/01 Drug Firms Treat PMS As a Mental Disorder
By TARA PARKER-POPE, THE WALL STREET JOURNAL, As
appeared in The Wall Street Journal, Section B, Front Page

IS SEVERE PMS, or premenstrual syndrome, a mental illness?
Some pharmaceutical companies and psychiatrists are treating
it as one. In new television ads, drug maker Eli Lilly is promoting
the drug Sarafem to treat the problem, now dubbed
Premenstrual Dysphoric Disorder (PMDD). But the pink and
purple pills aren’t a new drug — they are simply repackaged
Prozac, the popular antidepressant.

3/11/01 Paper: Co. Knew of Drug-Liver Link

Warner-Lambert Co. downplayed liver damage concerns as it
sought federal approval for its diabetes drug Rezulin, the Los
Angeles Times reported Sunday.

2/24/01 Paxil Lawsuit

This is our 2nd update (“sitrep” or “situation report”) in our Paxil
withdrawal lawsuit (“Nguyen & Farber v SmithKline Beecham
Corporation”). We filed the case August 18, 2000 against
SmithKline (now “GlaxoSmithKline) in Superior Court, Santa
Clara County, San Jose, California.

2/19/01 Urgent Phenylpropanolamine Recall

Read more about the FDA warning about drugs containing the
ingredient Phenylpropanolamine found in many common over
the counter medications.

3/3/01 US Congressman Dan Burton Requests Immediate
Vaccine Recall

3/5/01 Use of Painkiller Grows Quickly, Along With Widespread
Abuse, By BARRY MEIER and MELODY PETERSEN THE NEW
YORK TIMES

…when the salesman suggested that OxyContin (which is as
potent as morphine) was safe enough to treat short-term pain,
Dr. Leong exploded. “We threw him out of my office,” said Dr.
Leong.

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2/24/2001 – Wall Street Journal Questions PMDD & Sarafem (Prozac)

Here comes the crowd!! Now that Lilly has their approval by the FDA to use
Prozac for PMS (PMDD), all the other makers of SSRIs are racing to get their
drugs approved to get their share of the profits. If this was not such a
horrifying situation with so many dying such terrible deaths everyday, many
more becoming so disabled from these drugs, and so many families being torn
apart from the behavioral reactions, it would almost be funny.

What is most ironic is that the psychologist mentioned at the end of the
article is right. I see women with severe PMS who mix some purified water
with lemon juice and drink a gallon a day for the week before their period
and any sign of PMS leaves. There are so many simple alternative choices for
this that it is amazing that Lilly has convinced so many that they have the
answer in a drug! Even more amazing is that they convinced the FDA – but then
the FDA is always amazing me with what they allow the public to be exposed to
as “safe”!

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
_________________________

Wall Street Journal, Section B, Front Page

February 23, 2001, Health Journal

Drug Firms Treat PMS As a Mental Disorder

By TARA PARKER-POPE
Staff Reporter of THE WALL STREET JOURNAL

IS SEVERE PMS, or premenstrual syndrome, a mental illness? Some
pharmaceutical companies and psychiatrists are treating it as one. In new
television ads, drug maker Eli Lilly is promoting the drug Sarafem to treat
the
problem, now dubbed Premenstrual Dysphoric Disorder (PMDD). But the
pink and purple pills aren’t a new drug — they are simply repackaged
Prozac,
the popular antidepressant.

Makers of similar antidepressants, known as serotonin reuptake inhibitors,
or
SSRIs, also may follow suit. In January, Pfizer asked the FDA to approve
Zoloft to treat PMDD. Forest Laboratories’ Celexa and GlaxoSmithKline’s
Paxil also have been studied.

The medical community, however, remains divided about whether PMDD is a
real disorder or simply a way for drug companies to cast a wider net in
search
of new customers. Critics are particularly concerned about labeling women
as
mentally ill because of problems associated with menstrual cycles.

“When you start calling what PMS is a psychiatric disorder, what are you
saying about the women of this world?” says Nada Stotland, director of
psychiatric education at the Advocate Illinois Masonic Medical Center in
Chicago. “This lends itself to prejudices people already have about women
being moody and unreliable.”

ALTHOUGH THE FDA has approved Sarafem to treat PMDD, the
psychiatric community is still debating the legitimacy of the disorder. The
American Psychiatric Association includes PMDD in the appendix of its
current
Diagnostic and Statistical Manual of Mental Disorders, the part of the
manual
reserved for issues needing further research before being officially
accepted as a mental illness.

Fueling skepticism about PMDD and Sarafem is the
fact that in August, Lilly, based in Indianapolis, loses
patent protection on Prozac, a drug with $2.6 billion
in sales last year, according to IMS Health. With
Sarafem, the firm now has a separate patent to use
the drug for PMDD through 2007, allowing it to
partially offset losses in sales as rivals produce
generic Prozac.

Repacking prescription drugs for other uses is
becoming more common. Glaxo, for example, has
repackaged its antidepressant Wellbutrin as the
stop-smoking aid Zyban.

Many physicians argue that PMDD is a legitimate mental illness triggered by
normal hormonal fluctuations in a woman’s menstrual cycle. About 3% to 5%
of
menstruating women are affected. “This is a subset of women who have
really,
really severe mood changes and changes in their behavior,” says Jean
Endicott,
professor of clinical psychology at Columbia University’s College of
Physicians
and Surgeons. “It can be very debilitating.”

Unlike other mental illnesses that affect a patient on a daily basis, PMDD
is said
to affect women during the week to two weeks before their period. The
symptoms include depression, anxiety, tension, anger, irritability and the
feeling
of being overwhelmed or out of control. Other symptoms also are typical of
traditional PMS, such as breast tenderness, headache, bloating and weight
gain.

In order to be diagnosed with PMDD, a patient must have at least five
symptoms, including one involving mood change, and be markedly impaired as
a result. Patients should track symptoms for two months before a diagnosis
is
made.

About 60% of women who take Sarafem for PMDD will be helped, according
to Dr. Endicott. Currently, the drug is taken every day, but researchers
are
studying dosing that would reduce the pills to several days a month,
limiting side
effects, which can include tiredness, upset stomach, nervousness, dizziness
and
difficulty concentrating.

A 38-YEAR-OLD Chicago flight attendant named Betsy, who didn’t want her
full name used, says the week before her period she felt like an
“over-wound
spring, getting wound tighter and tighter,” and would often scream and lose
control. “That’s not my normal disposition,” she says. “I knew something
wasn’t
right.”

She noticed the correlation with her menstrual cycle and discussed her
problems with her gynecologist, who prescribed Sarafem. “It has completely
taken away the symptoms,” she says.

Dr. Stotland and other critics, however, worry that eager patients may push
to
be prescribed Sarafem as a quick fix, preventing doctors from diagnosing
other
serious health problems. Dr. Stotland says research has shown that more
than
half of the women who believe they have severe PMS actually suffer from
other
problems, such as depression, panic disorder or even domestic violence.

Lilly’s marketing of Sarafem also has sparked controversy. The first ads
showed a frustrated woman wrestling with a shopping cart. “Think it’s PMS?
It
could be PMDD,” the ads said. But the FDA said the ads trivialized the
seriousness of PMDD, and the campaign was pulled. New ads show one
woman arguing with her husband and another frustrated because she can’t
button her pants.

Lilly spokeswoman Laura Miller says the ads attempt to show the full gamut
of
PMDD symptoms. “It’s up to the doctor and the woman to determine whether
she has PMDD and whether treatment is appropriate,” she says.

But Paula Caplan, a psychologist and affiliated scholar at Brown
University’s
Pembroke Center for Research and Teaching on Women, says instead of
labeling women as mentally ill, physicians should urge diet changes,
exercise,
less caffeine and even calcium supplements. “But nobody makes much money
off calcium tablets,” she adds.

E-mail comments to Tara Parker-Pope at healthjournal@…

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12/30/2000 – McDermott on Prozac, Paxil AND Deseryl?

If the Boston Herald’s source got it right, McDermott was on one heck of a
combo!!! All three are contraindicated in mixing any of the three with even
one of the others, much less two!! His serotonin levels must have been out of
sight using three serotonergic meds! No one should be surprised that he went
psychotic on this combination, even if the drugs were given in succession,
rather than together.

Let me also point out that the so called “Prozac defense” HAS been used
successfully several times. And as far as I know Kip Kinkle’s attorney never
used the information on the drugs in his murder case.

Prozac would also have been found guilty in a case that is almost identical
this one – that of Joseph Wesbecker in Louisville, KY, who also after being
treated with Prozac went on a shooting spree with an AK47 where he worked.
That is it would have been used successfully if Eli Lilly had not bought off
the plaintiffs in the middle of the trial and then neglected to disclose that
payoff to both the judge and the jurors. Judge John Potter deserves a metal
for taking Lilly and the plaintiffs to court and forcing them to admit the
truth of what happened. Although it took him a couple of years he said that
he did it because he did not want his courtroom turned into an advertising
agency for Prozac and pointed out that this is a public safety issue.
Amazingly Lilly has used that case to defend their drug ever since! (Although
my book discusses the Wesbecker case briefly, the book Power to Harm covers
the Wesbecker case in detail.)

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
________________________________

“According to the source, who is familiar with the still mounting case,
McDermott had been taking Paxil, Prozac and Desyrel – all of which are SSRIs
designed to treat depression, social phobias or anxiety.”

Source: Suspect was taking drugs for depression

by Dave Wedge, Tom Farmer and Jose Martinez
Friday, December 29, 2000

The hulking computer technician accused of gunning down seven of his
co-workers at a Wakefield high-tech firm this week suffered from a host of
mental illnesses – including schizophrenia – for which he was taking a trio
of antidepressants, a source told the Herald yesterday.

Accused killer Michael M. McDermott at his arraignment Wednesday. (Staff
photo by Matthew West) “He’s got some serious psychological issues and a
long (psychiatric) history,” the source said of 42-year-old Michael
“Mucko” McDermott.

McDermott, a divorced Navy veteran from Marshfield who lived most recently in
Haverhill, suffered from severe depression, paranoia and schizophrenia, and
had been in psychiatric treatment for some time, according to the source who
spoke on condition of anonymity.

To cope with his mental disorders, McDermott was prescribed several Selective
Serotonin Reuptake Inhibitors, or SSRIs, designed to increase brain
serotonin. Low levels of brain serotonin can lead to depression and anxiety
disorders.

A source familiar with the investigation said McDermott’s supervisors at
Edgewater Technology Inc. did not appear to know he was using the medication.

McDermott is being held without bail on seven counts of first-degree murder
in Tuesday’s massacre at Edgewater. Prosecutors have said McDermott wielded a
shotgun and semiautomatic rifle with premeditated precision and extreme
atrocity, hunting down workers in the company’s accounting and human
resources offices but letting others flee unharmed.

He was arrested by police who found him sitting in the lobby near the bodies
of two of his victims. At least two Edgewater employees witnessed the
rampage, including one woman who hid behind a chair and her coat beneath a
desk in the accounting office, where two of her co-workers were killed.

Middlesex County District Attorney Martha Coakley has said McDermott may have
been seeking vengeance over the impending docking of his paychecks by
Edgewater to satisfy an IRS demand for back taxes. Sources say the IRS orders
would have left McDermott with just $275 every two weeks.

But investigators also are looking for clues about what drove the man to kill
by delving into the contents of computers seized from McDermott’s office and
home, where police also found bomb-making literature and materials. One
source said McDermott had attempted to wipe out the hard drive of his office
computer the day of the shootings.

Yesterday, neither Coakley nor McDermott’s defense attorney, Kevin
Reddington, would discuss the case or McDermott’s mental state and
psychological history. However, at Wednesday’s arraignment, Reddington raised
the specter of an insanity defense by saying his client had been seeing
psychiatrists and asking the judge to OK his continued medication.

Insanity defenses rarely succeed. The so-called Prozac defense has been
unsuccessfully attempted in dozens of murder cases nationwide, including in
the case of Kip Kinkel, the teenager who killed his family and two
schoolmates in Springfield, Ore.

According to the source, who is familiar with the still mounting case,
McDermott had been taking Paxil, Prozac and Desyrel – all of which are SSRIs
designed to treat depression, social phobias or anxiety.

The source also said orders have been sent by doctors to the Middlesex County
Sheriff’s office so McDermott can receive his medications in the Cambridge
jail. He will be examined by psychiatrists some time in the next week, the
source said.

The revelations about McDermott’s psychiatric history emerged as his
co-workers returned to St. Joseph’s Church – where so many of them had sought
refuge and solace in the hours after the shootings – for a memorial service
in honor of their seven slain colleagues.

“We’re all hurting and grieving, but I can’t tell you how much we’re pulling
together as a team,” Edgewater Technology Chief Executive Officer Shirley
Singleton said after meeting with her employees for the first time since the
shootings.

The company has started a memorial fund for the families of the slain workers
with a $70,000 donation. Singleton also said grief counseling, which began
yesterday at the firm, would continue as long as employees need help.

She declined to discuss the shootings that claimed the lives of Jennifer
Bragg Capobianco, 29; Janice Hagerty, 46; Louis Javelle, 58; Rose Manfredi,
48; Paul Marceau, 36; Cheryl Troy, 50, and Craig Wood, 29.

State and federal authorities are seeking the origin of McDermott’s weapons,
including the AK-47-style rifle and 12-gauge shotgun that he is alleged to
have used to kill the four women and three men, a .32-caliber pistol found in
his pants pocket and a large-caliber hunting rifle found in a locker by his
desk.

Haverhill police began looking for McDermott late Christmas Eve after someone
reported hearing gunfire in the woods near Crystal Lake, where a man fitting
his description was spotted by a car with the license plate “MUCKO.”
Officers traced the car back to McDermott’s apartment but could not locate
him despite several more visits Christmas Day.

One day later, investigators believe McDermott lugged the weapons unnoticed
into the Harvard Mills complex, one law enforcement source said. Two
soft-sided gun cases were found under his desk.

“He walked them right in and placed them under his desk,” the source said.
“They had a skeleton crew working that day and no one apparently saw him or
recognized what the cases were for.”

The source said McDermott loaded the shotgun with buckshot at his work
station before embarking on his killing spree. The source, a longtime
investigator, said the carnage he witnessed in the shooting’s aftermath left
him shaken.

“I was sick to my stomach over it,” he said. “It was unlike any other
murder scene because it was in a work setting. It was almost surreal. One of
the (dead) women had her head resting on her arm like she knew she was going
to get it.”

Meanwhile, gun control advocates held a rally outside the State House to urge
lawmakers to ban the sale of assault weapons like McDermott’s. Although
Massachusetts already has the country’s toughest gun law, it does not ban the
sale of assault weapons manufactured before September 1994.

“They have no legitimate use in a civilized society other than for law
enforcement,” said Stop Handgun Violence co-founder John E. Rosenthal.

Kevin Sowyrda, spokesman for the Gun Owners Action League, declined to
comment specifically on an assault weapon ban but said, “The last thing we
need in this period of mourning are political rallies.”

Donations may be made to the Edgewater Wakefield Memorial Foundation, Box
2133, Wakefield, Mass. 01880-6133. Donations may also be made at Fleet bank
branches.

Karen E. Crummy contributed to this report.

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12/29/2000 – Tis the Season for Drug Pushing

I would hope that you have been carried away by the hustle
and bustle of the Christmas season – celebrating Christmas
as it should be celebrated as you recalled the real purpose
of this holiday season.

Pharmaceutical companies look at this season as the time
of opportunity for recruiting new guinea pigs for their drug
trials. The holidays are a time for families to visit and celebrate
together, but, for some, it can be depressing as they look at a
broken family, loss of a loved one, not enough money for gifts,
etc. In those situations, the drug companies want us to believe
that they have the only answer for those holiday blues – their
little green, blue and pink pills.

Eli Lilly, for one, is most definitely taking advantage of the season
– offering to one and all their own brand of “holiday cheer” – Prozac.
One evening on prime time TV during the CBS Christmas special we
were forced to tolerate their “Welcome back to Prozac” commercial
where we see an athletic young woman jogging through the screen
to come back to Prozac. And another woman in the commercial
opens her shutters to welcome the morning sun again.

The honest commercial would show an overweight woman with
globs of hair falling out, who could barely catch her breath due
to the severe fatigue of the post drug period along with the
involuntary muscle jerking and jumping from the electrical
shocks running through her body. She would also be suffering
the severe panic and anxiety attacks that come with withdrawal
as she then drags herself back to the Prozac bottle! After all,
it is the serious delayed withdrawal with its terrible bouts of
rebound depression caused by the drugs that brings
the large majority of users back to Prozac or any of the
other drugs in the Prozac family of antidepressants.

Then the other woman who opens her shutters would be
welcoming the late afternoon sun, rather than the morning sun,
as she would not be able to get up before noon due to the total
upheaval in her sleep patterns. She would also be covering her
eyes from the sun due to pain the light would cause – a result of
the elevated serotonin levels she is left to deal with after her
first round of Prozac.

Just last month an ad ran in our papers here in Salt Lake City
(better known as “Prozacopolis” or the “Prozac laboratory” due
to our extremely high use of these drugs here) asking for elderly
guinea pigs. The caption above the photo of an elderly oriental
woman read in big bold print “EARN MONEY FOR CHRISTMAS!”
They were offering $750 to those 65 – 85 years of age (most on a
fixed income who could certainly use an extra $750 for Christmas)
to take Prozac for 42 days.

The ad stated that there was no need for these volunteers to be
depressed, but they needed to be healthy in order to take part in
the study. There was no warning at all that these volunteers would
most likely need to use the $750 for burial expenses or for a drug
withdrawal clinic to help them off the drug. And there was no hint
that they might need the extra $750 for additional Prozac to ward
off the terrible withdrawal symptoms.

The drug companies are definitely targeting the weakest among
us – the elderly and the children. Both are far more vulnerable to
the effects ofdrugs as the metabolism is weaker in both plus the
children have systems that are yet developing. US News and
World Report recently published an article on what is going on
with children in the testing of these drugs and the why behind
the testing – extended patents of these drugs bringing in MILLION$
for the drug companies. See it below. Note that the magazine is
protecting their advertising dollars by soft pedaling the most
horrific drug disaster this world has ever faced – the mass
drugging of helpless children with these very powerful
mind-alterning drugs.

How many more mass shootings do we need to witness? How
many more must die to awaken us to the terrible position we are
in as a result of these drugs? The horrors of medical “research”
are indelibly etched in one’s mind with a visit to Auschwitz or
Dachau. The picture of one man grasping his head with both
hands as he screamed out in pain was enough to send me
running out of Dachau as fast as possible and swearing never
to return. The emotions and memory of that experience will be
with me forever. The difference here is that Hitler did not have
mass media to entice people through flowery ads to come to the
camps “drug clinics” willingly to undergo “treatment” and the
human guinea pigs were not offered money to participate in
his horrific medical research projects.

If using the most helpless and dependent upon us as guinea
pigs does not incur the wrath of God as we have never seen
before, I do not know what will. Surely this must serve as a
wake up call to the terrible state of our society. If it does not,
we are not worth saving as a world, as a country, or as a people.

A pharmacist who has witnessed many of his customers end up
with criminal charges after using SSRI antidepressants stated to
me only a few months ago that he fears that in the next 10 to 20
years we will see thousands of “little Hitlers” running around as a
result of our use of these drugs on our children. He then pleaded
with me, “Please tell me that you and I are not the only ones who
see this!”

I urge you to not sit back in silence a moment longer. There is not a
family in our country that has not been adversely affected in some
way by these drugs at this point. Escaping this mass drugging of
our population is impossible in our world today. We are all surrounded
by it and must address such a serious assault on life as we know it. If
you have not yet done so, please contact local radio stations, television
stations, newspapers, government officials, police and firemen who have
to deal with the end result of these drugs, and give them our website as
a reference. Ask them to have one of our directors on as a guest on a
show to discuss this issue. Then warn your own families, friends and
neighbors before you are faced with a death you that you might have
been able to prevent by sharing this information. Stop worrying about
how someone will react to your message. Think of how you will feel
knowing that you did nothing to save a life or several lives that are
now gone as a result of these drugs.

We cannot stand by and watch this happen any longer – especially
at this time of year. I know of no greater gift we can give this
Christmas season than one of truth and life and health and
peace of mind – a life free of these drugs.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.usnews.com/usnews/issue/000417/nycu/kids.htm

Drug companies are clamoring for kids, but scrutinize the study before
signing up

By Stacey Schultz

Five-year-old Emily Morock is being very brave. As the nurse at Children’s
Mercy Hospital in Kansas City, Mo., draws blood from her left arm, the small
girl watches, fascinated, and doesn’t flinch. It wasn’t so easy for little
Teyonna Latimer, also 5, who, moments earlier, kicked and screamed as her
mom and a nurse held her still for a needle stick.

The girls are not sick: They are enduring the needles in the name of
science. Like thousands of children across the country, Emily and Teyonna
are taking part in a clinical trial of a drug approved for adults but never
studied in children–in this case an antihistamine. Doctors at Children’s
Mercy Hospital are trying to figure out how much is needed to relieve
allergies in a small child. “Up until a few years ago, if you had a
200-pound man and the dose was 200 mg, you would guess that a child who
weighs 10 pounds should get 10 mg,” says Kathy Johnson, clinical research
coordinator at the hospital. “But there is so much more we need to
understand about drug metabolism before we give medicines to young
children.”

A concerted drug-testing effort is filling that gap. In 187 pediatric trials
now planned or underway, researchers are studying the safety of
antidepressants, the proper doses of heart medication, and the best ways to
use potent antibiotics, among other things. The boom was sparked in 1997
when Congress granted drug companies an extra six months of patent
exclusivity, potentially worth millions of dollars, for medicines tested in
children; after December, the Food and Drug Administration will require that
virtually all new drugs be tested in kids.

“I have been doing pediatric research for 25 years,” says Philip Walson,
professor of pediatric pharmacology and pharmacy at Ohio State University.
“And I can honestly say that there has been more research done in the past
three years than in all the others combined.”

Risk and reward.
The effort will require more than 17,000 children–and increasing numbers of
doctors are asking parents to sign up their kids. The decision of an adult
to enter a clinical trial is rarely easy; deciding to sign up a child can be
even trickier.

Some experts worry that the rush to test drugs in kids has led to ethically
questionable behavior, such as taking children off a standard medication to
study the effects of a newer one or offering families large sums of money
for taking part. On the plus side, children in trials get close medical
attention and a chance to make a difference to other kids.

For sick children, a study of a new drug also offers a chance of getting
more-effective therapy. And the risks are small, providing parents choose
trials conducted by experts in pediatric medicine and closely supervised by
local review boards.

Prescribing drugs for children is a kind of experiment in any case, medical
researchers are quick to point out, because 80 percent of the drugs given to
kids have been tested only in adults.

Under FDA regulations, doctors are free to use these drugs in children, but
dosages and toxic effects can be guesswork. In rare cases, those guesses
have been fatally wrong. Decades ago, chloramphenicol, an FDA-approved
antibiotic, killed several infants when it accumulated to toxic levels in
their systems. Doctors later discovered that children do not metabolize the
drug the same way adults do. “We didn’t study it in kids before we gave it
to them,” says Dianne Murphy, associate director for pediatrics at the FDA.
“And we really didn’t understand the harm we were causing.”

The new wave of trials addresses the problem by testing approved drugs in
healthy kids like Emily and Teyonna, to see how their bodies process the
drugs, and by comparing the effectiveness of different drugs in sick kids.
No clinical research is without risks, says Ralph Kauffman, director of
medical research at Children’s Mercy Hospital, but the hazards of pediatric
clinical trials usually amount to inconvenience, not danger. “Studies may
include additional visits to the doctor, extra blood tests, X-rays, and
urine samples,” Kauffman says. “These are not things that inflict lasting
harm on a child.”

Most drugs tested in children have been studied previously in adults,
Kauffman adds. “There is always a small risk of an adverse reaction to a
drug,” he says. But because kids are so closely monitored in clinical
trials, “children are at much lower risk of an adverse event in a study than
they are taking a drug that has never before been tested.”

Still, parents have been spooked by rare but well-publicized clinical trial
disasters such as the death last fall of 18-year-old Jesse Gelsinger in a
study of gene therapy at the University of Pennsylvania. “You ask some
parents to join a clinical trial, and they immediately turn off,” says
Jeffrey Blumer, professor of pediatrics and pharmacology at Case Western
Reserve University School of Medicine in Cleveland.

Other participants sour later, when they discover that their child got the
old therapy during a trial of a new drug or got a dose of the new medication
too small to do any good. When a family doctor or pediatrician suggests
joining a clinical trial, Blumer says, parents should check out who is
running it. Look for researchers who have university affiliations, he
advises, because university-based research often gets more careful ethical
scrutiny.

Committees of experts called institutional review boards (IRBs) act as the
ethical watchdogs, and university-based hospitals are likely to have an IRB
on site, rather than relying on a centralized IRB that may not monitor
individual trials as carefully. On trial. Mark Brown, associate professor
of clinical pediatrics at the University of Arizona, learned how big the
difference can be when he tried to recruit patients for a trial of a new
asthma drug. The study sought kids with asthma who were not already taking
inhaled antinflammatory drugs. “Our IRB felt that it would be unethical to
take a child off medication if it was already controlling the condition,”
Brown says. Every asthmatic child his office could identify was already on
medication, preventing him from recruiting a single patient.

But just blocks away another doctor who was also taking part in the study
exceeded his quota. The reason: The physician encouraged patients to stop
their medication and join the trial. Brown suspects a less stringent IRB had
OK’d this potentially risky step. Parents should also get a full explanation
of the purpose and plan of the study, along with potential risks and
benefits.

Emily’s mother says that a nurse called her and explained the trial. Later,
she signed a six-page consent form detailing the same information. Ben
Wilfond, a bioethicist at the National Institutes of Health, says parents
should discuss these materials with their child’s primary-care physician as
well as with the study staff. “Take your time making the decision,” Wilfond
says. “If someone is trying to pressure you to sign up, that’s a red flag.”
Don’t be surprised if the trial organizers offer money or gifts.

Roughly a quarter of pediatric studies pay for participation, typically from
$200 to $400, according to Jonathan Rackoff, a researcher at NIH. Emily and
Teyonna both received $200 for their cooperation. NIH’s Wilfond says
incentives are not necessarily unethical. But some studies are offering
$1,000 or more, which bothers Wilfond: “When the money becomes too large and
distorts people’s judgment, that’s a problem.”

Ultimately, experts say, taking part in a well-run trial can be rewarding
for children. They stand to gain a sense of pride in helping other kids and,
along the way, learn a little bit about medical science. Loren Persley, a
16-year-old from Kansas City who entered a study of an antihypertensive drug
last year, says she was paid about $400. But her favorite part of the study
wasn’t the cash. It was staying overnight in the hospital and watching
technicians test her blood in the lab. “I got to see a readout on paper of
how high the levels of the drug were in my blood,” Persley says. “I had so
much fun, the money didn’t really matter to me.” But, she adds, “it was a
nice way to say thank you.”

© U.S.News & World Report Inc. All rights reserved. Disclaimer

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12/29/2000 – Sarafem Nation – Renamed Prozac Targets Huge Market: Premenstrual W

http://www.villagevoice.com/issues/0049/spartos.shtml

Published December 6 – 12, 2000

Renamed Prozac Targets Huge Market: Premenstrual Women

Sarafem Nation

by Carla Spartos

A visibly irritated woman yanks on a supermarket shopping cart that’s stuck
in its stack while a soothing female voice-over recites a litany of PMS
symptoms. She asks, “Think it’s PMS? Think again. . . . It could be PMDD.”

Premenstrual Dysphoric Disorder, or PMDD, is a fresh-minted mental illness
that purportedly affects 3 to 10 percent of all menstruating women. Mood
symptoms like depression, anxiety, anger, irritability, or sensitivity to
rejection are said to be so severe the week before a woman’s period that it
impairs her functioning. According to Dr. Jean Endicott, professor of
clinical psychology at Columbia University’s College of Physicians and
Surgeons, “What’s ordinarily irritating becomes enraging.”

To be diagnosed with PMDD, women must keep a daily diary of their symptoms
for the duration of two menstrual cycles. The symptoms must kick in after
ovulation and disappear once menstruation begins. “The timing is exquisite,”
remarks Endicott.

The timing is also exquisite for Eli Lilly and Company to make a financial
killing off of PMDD. Next year, the drug company will lose its patents on the
antidepressant Prozac, and with them its monopoly on the market. To ward off
declining profits, Lilly has found another use for its wonder drug—treating
PMDD.

In July, Lilly got Food and Drug Administration approval to market Prozac
under the new name Sarafem. The company is packaging the drug in pretty pink
and lavender capsules, exclusively for women, most in their late twenties or
early thirties. Says Laura Miller, a spokesperson for Lilly, “Women told us
they wanted treatment that would differentiate PMDD from depression.”

According to Endicott, the symptoms of PMDD primarily interrupt
“interpersonal relationships”—basically, those involving spouses, children,
and coworkers. In one group of women with self-described premenstrual
symptoms, researchers found no increase in absenteeism or decline in work
performance, although the women themselves perceived that to be the case.

“PMDD is unique because there is virtually no other disease that people
insist upon having,” says Dr. Nada Stotland, chair of psychiatry at Illinois
Masonic Medical Center. According to Stotland, the majority of women who go
to PMS clinics have symptoms that aren’t in fact related to their periods.
“Most are depressed everyday. Others have anxiety and personality disorders.
Some are in psychological pain because they are being abused.”

That women might seek help on the pretense their problems are hormonally
based makes PMDD more slippery to recognize and study. Stotland says she’s
particularly concerned that Lilly is targeting almost exclusively OB-GYNs as
Sarafem prescribers, which puts gynecologists in the position of treating
mental illness. She says Lilly’s advertising campaign may convince enough
women they need Sarafem, leading them to pressure their doctors to skip the
two months needed for diagnosis and instead send them straight to the
pharmacy. And since Sarafem will also work for those with chronic depression,
a misdiagnosis can go undetected.

Proponents of Sarafem downplay the potential for misuse. “I doubt that a lot
of people who don’t need the treatment would get it,” argues Endicott.
“First, it’s a prescription drug. Second, women are not big pill poppers.”
Sherry Marts, scientific director of the Society for Women’s Health
Research—a nonprofit organization that promotes research in women’s health
issues—concurs. “This is a real medical condition that requires treatment for
a small percentage of women,” she says.”Not, ‘I’m a little bloated, I’m gonna
pop some Prozac.’ ”

But critics claim that 3 to 10 percent of all menstruating women is no small
number. “That’s a minimum of half a million North American women suffering
from PMDD,” says Paula Caplan, a psychologist and affiliated scholar at Brown
University’s Pembroke Center for Research and Teaching on Women.

Whether PMDD is a real condition is still subject to debate. Although both
sides agree that a certain subset of women may be sensitive to normal
hormonal changes, that’s about all they agree on. The question remains, if
women sometimes snap at their husbands if they don’t pick up after
themselves, or at their kids if they do poorly in school, should they be
branded with a mental disorder? “Women are commonly in situations defined by
stress—responsibility without authority,” says Stotland. ‘That’s almost the
definition of a typical woman’s job.”

Some doctors fear that women who have legitimate reasons to be unhappy will
be silenced by the PMDD diagnosis, and that Sarafem could prove to be the
Valium of the naughts. “Ordinary, healthy changes in mood and emotion are
being pathologized when they happen to women, and since women believe they
shouldn’t feel irritable, angry, or depressed, they are quick to blame
themselves,” says Caplan. For men, “There’s no testosterone-based aggressive
disorder.”

Endicott disagrees. “If men had PMDD, it would have been studied a long time
ago.”

But would it? “To say that a huge proportion of the female population is
disabled represents a potentially horrendous setback for women in the
workplace,” says Stotland. She points to the woman who finally speaks up to
her boss and in return is asked, “Oh, is it that time of the month?” Agreeing
to that kind of put-down might save the woman her job. PMDD could reinforce
the stereotype of the hysterical woman not only to employers, but to women
themselves.

Caplan says that a diagnosis of PMDD will have far-reaching legal
implications as well. Might women who’ve been labeled as mentally ill be
deprived of the right to make their own decisions? Might they lose custody of
their children in divorce cases? In other words, will PMDD sufferers be seen
as the biological equivalent of Dr. Jekyll and Mr. Hyde?

That’s already the most common complaint of PMDD sufferers, says Endicott,
who reports women saying over and over, “This isn’t me.” Lilly promotional
literature echoes this sentiment. “The good news is there is treatment
available that can help you feel more like the woman you are every day of the
month,” the brochures say. But who is this woman? And why are we so concerned
with her hormones?

——————————————————————————

One thing is for sure: Eli Lilly and Company has a financial stake in PMDD.
Lilly’s Prozac patents are expiring in 2001 and 2003. This means the market
will open up to cheaper generic competitors. Analysts have estimated that
Prozac sales will decline drastically—from about $2.51 billion in 2000 to
$625 million in 2003. Sarafem will provide a significant new market—women—to
boost profits. That’s a smart move, since women are the primary users of
drugs that alter mood. And, according to documents posted on the FDA’s Web
site, Lilly has proposed a “pilot study of PMDD in adolescents to estimate
its response to treatment with fluoxetine.” Fluoxetine, by the way, is the
generic name for Sarafem (and Prozac).

Another plus for Lilly is that creating a new and separate trademark for
Prozac lessens the stigma associated with antidepressants, and lets the
company dodge some recent bad press, from the publication of Harvard’s Joseph
Glenmullen’s Prozac Backlash to a new study in Brain Research that suggests
the antidepressant may cut off axons of the nerves they target—in effect
causing brain damage.

By 2004, Sarafem sales are expected to climb to $250 million a year,
according to Bear Stearn’s Bottle Report. Lilly would not divulge projected
sales nor the amount of money spent marketing, researching, and developing
Sarafem, but their financial report shows a lot of zeroes. For the first
three quarters of this year, the corporation spent close to $2.3 billion in
marketing and administrative costs, much more than its research and
development, which totalled about $1.5 billion.

But most extraordinary is that the federal government is convinced of the
existence of PMDD, while the psychiatric community isn’t so sure at all. PMDD
is currently listed in the appendix of the DSM-IV—the psychiatrist’s bible of
mental illnesses—as “needing further study.”

The controversy began in 1987, when the compendium first included specific
criteria for Late Luteal Phase Dysphoric Disorder—the former name for
PMDD—in its appendix as a “proposed diagnostic category” needing more
research. In 1993, as the American Psychiatric Association’s task force was
compiling the fourth edition of the manual, the category was revisited.
Should it remain in the appendix, get moved to the body as a recognized
diagnostic category, or be removed altogether?

The committee decided to keep PMDD in the appendix. According to Psychiatric
News, the APA’s professional newsletter, “Members of the task force agreed
there were a number of problems with methodology within the PMDD literature.
The problems included unclear definitions, small sample sizes, lack of
control groups, lack of prospective daily ratings of symptoms, no
documentation of the timing and duration of symptoms, and failure to collect
appropriate hormonal samples.” However, the committee suggested specific
criteria for diagnosing PMDD, including specs for symptoms and timing.

Five years later, the fate of PMDD was still unclear. In October 1998, the
Society for Women’s Health Research organized a discussion, headed by
Endicott, to answer this question: “Is premenstrual dysphoric disorder a
distinct clinical entity?” Once again, experts reviewed the PMDD literature,
this time in the company of FDA and Lilly representatives.

Dr. Sally Severino, a now retired professor of psychiatry at the University
of New Mexico, reiterated flaws in the research. First, just because women
can be identified by PMDD criteria “is not proof that PMDD exists as a valid
diagnosis.” Second, although cross-cultural studies identified physical
complaints related to menstruation, mood symptoms like anger and irritability
were not found worldwide to the same degree as in America. Severino argued
that if PMDD can’t be identified in other populations, then “consideration
must be given to the criticism that PMDD is a culturally bound syndrome or an
unnecessary pathologizing of cyclical changes in women.”

Ignoring these objections, the round table concluded that PMDD was a
“distinct entity with clinical and biologic profiles dissimilar to those seen
in other disorders.” In other words, a mental illness.

What changed between 1993 and 1998? For one thing, Lilly funded a 1995 study
that showed Prozac was effective in treating PMDD. Published in The New
England Journal of Medicine, the study had a large sample size, and was
placebo-controlled and double-blind (meaning neither the doctor nor the
participant knows who’s getting drugs or a sugar pill)—all the makings of a
pristine scientific inquiry. A slate of studies followed suit, all with the
same results: About 60 percent of women diagnosed with PMDD respond to
Prozac.

Yet one 1998 study discussed by Endicott’s roundtable found that 55 percent
of women diagnosed with premenstrual symptoms got significant relief from
increased calcium intake. The group went on to comment that “the area of
calcium is not well explored.” That leads critics to wonder why other
treatment options are getting the cold shoulder. “Why not spend pages and
pages pushing calcium?” asks Caplan, who served on the 1993 DSM committee.
And although there is evidence that people with PMDD can feel better with
only intermittent doses of Prozac—and suffer fewer side effects like sexual
dysfunction—the studies Lilly presented to the FDA looked solely at the
effectiveness of daily doses, or roughly double the amount some researchers
say is needed.

According to Caplan, almost all of the data the roundtable evaluated fell
into two categories: the old problematic studies available to the DSM-IV
group or the new research into using Prozac to treat PMDD. “There was nothing
that looked at the validity of the PMDD construct,” says Caplan.

Did Lilly railroad Sarafem through? Two members of the 16-person roundtable
conducted PMDD research funded by Lilly, and another member has received
honoraria as a speaker for Lilly. Endicott, who hasn’t received research
funds or speaking fees from Lilly, opened the company’s November 1999
presentation to an FDA advisory committee, which voted unanimously in favor
of the new PMDD indication for Prozac. In addition, the Society for Women’s
Health Research trumpets on its Web site an “unrestricted educational grant
from Eli Lilly and Company,” which they’ve used to promote PMDD awareness,
including a national survey conducted in November to gauge women’s awareness
of PMDD and available treatment (i.e., Sarafem). “Lilly had done an
extraordinary job of getting this to the public,” says Stotland.

Researchers taking a ride on the drug-company gravy train is not unique to
those who studied PMDD, but it can have effects on scientific research. “I
don’t think people falsify results. But what kinds of questions do you ask?
Which results do you publish?” asks Stotland. “When I was a resident it was
the departments who had money to bring in speakers. Now, it’s the drug
companies who are flying people around.”

Incidently, at the time of the interview, Stotland was attending a PMDD
conference held at a Palm Springs resort, courtesy of Eli Lilly.

Tell us what you think. editor@…

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6/13/2000 – Quandary Over Prozac – Boston Globe Editorial

http://search.boston.com/globe.vts

A BOSTON GLOBE EDITORIAL

The Prozac Question

Eli Lilly, manufacturer of the highly successful antidepressant drug Prozac,
wants to have it both ways. While it has always insisted that the drug does
not cause even a tiny percentage of its users to contemplate suicide, it also
wants to sell an updated version of Prozac with a patent which states
specifically that one of its advantages over the original is that it is less
likely to cause suicidal thoughts.

Now the firm has been caught in this contradiction by a Houston lawyer whose
clients unsuccessfully sued Lilly after their father killed his wife and then
himself while on the drug. By the time of the trial last year, Lilly had
bought rights to the new patent, boasting of its superiority over Lilly’s
original Prozac, whose patents expire in 2004.

The lawyer says his clients would have gotten a fairer trial if Lilly had
come forward with that language, and he is now asking a federal court for a
new trial. His clients deserve that chance, and the Food and Drug
Administration should ask Lilly why, in light of the language in its new
patent, it is not warning current Prozac users about suicidal thoughts.

Even if it had been aware of the new patent language, the jury might still
have exonerated the drug manufacturer. Prozac is hailed by many health
professionals for treating often debilitating depression and actually
preventing suicides. And while a small percentage of Prozac users have
committed suicide, it is not easy to prove that it was the drug and not the
underlying illness that was the cause.

Lilly, for its part, notes that a separate company developed the new version
of Prozac and wrote the patent language for it before Lilly acquired the
patent. And Lilly says ”not all of the `side effects’ listed in the patent
are scientifically demonstrated facts.” But why should a patent have been
issued for a new version of Prozac if it does not reduce side effects like
suicidal thoughts?

The FDA should reopen the question of whether the patent language on the new
Prozac is not a warning that users and prescribers of the original Prozac
should have been receiving all along. The patent’s message should also be
conveyed to a jury in a second trial of the Houston lawyer’s case.

This story ran on page A26 of the Boston Globe on 6/13/2000.
© Copyright 2000 Globe Newspaper Company.

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