SOURCE: Shire Pharmaceuticals Group plc Pivotal Study of New, Once Daily ADHD Medication to be Presented At American Psychiatric Association Meeting -- Study Is One of The Largest Ever ADHD Medication Trials --

ANDOVER, United Kingdom, March 5 /PRNewswire/ -- Shire Pharmaceuticals Group plc (Nasdaq: SHPGY; London: SHP.L) today announced that new pivotal data on the once daily medication it is developing for the treatment of attention deficit/hyperactivity disorder (ADHD) have been accepted as a platform presentation at the annual meeting of the American Psychiatric Association (APA). The oral presentation of safety and efficacy results will take place on Wednesday, 9 May, at 11:00 am at the APA's 2001 annual meeting in New Orleans.

The once daily medication, currently known by its project designation, SLI 381 (proposed Trade Mark ADDERALL XR), is a novel formulation of ADDERALL® (mixed salts of a single-entity amphetamine product) that incorporates Shire's Microtrol(TM) advanced drug delivery system. Shire filed a new drug application for SLI 381 with the US Food and Drug Administration on 3 October, 2000.

"We are honored that the APA has chosen the study results for a platform presentation," said Wilson Totten, Shire's Group R&D Director. "We believe strongly in this product, and our hope is that if approved by the FDA, it will have a profound effect on the way ADHD is treated."

The Phase III, randomized, double blind, placebo controlled, parallel group study is one of the largest ever medication trials in ADHD research. The study results will be presented by Joseph Biederman, M.D., Professor of Psychiatry at Harvard Medical School, who participated in the clinical trial and is a world renowned researcher in the field of ADHD and pediatric psychopharmacology.

"Having these study results presented at APA will bring attention to the need for once daily dosing of ADHD medication, the future of ADHD treatment," Dr Beiderman said.

About ADHD

ADHD is considered the most commonly diagnosed psychiatric disorder among children.(A) Children with ADHD often are inattentive, impulsive, and hyperactive - - difficulties serious enough to interfere with their ability to function normally in academic or social settings.

Although there is no ``cure'' for ADHD, physicians, parents, teachers, nurses, and advocates are finding ways to help people with the condition learn to adapt to their academic, social, and work settings. ADHD usually can be successfully managed with a combination of treatments, including educational approaches, psychological and behavioral therapies, and medication. A recent government-sponsored clinical trial found that therapies that include carefully monitored medication are more effective than those that do not, such as behavioral therapy alone.(B) Medication should be considered part of an overall multimodal treatment plan for ADHD.

Shire Pharmaceuticals Group plc

Shire is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology and gastroenterology. The Group has a sales and marketing infrastructure with a broad portfolio of products, with its own direct marketing capability in the US, Canada, UK, Republic of Ireland, France, Germany, Italy and Spain and with plans to add Japan by 2004. Shire also covers other significant pharmaceutical markets indirectly through distributors and sales coverage continues to grow.

Shire's global search and development expertise has to date successfully provided eight marketed products, of which Reminyl* for the treatment of Alzheimer's disease has recently been launched in the UK, its first market in Europe. The National Institute of Clinical Excellence (NICE) recommended on 19 January 2001 that treatment for Alzheimer's disease be made available through the National Health Service (NHS) in the UK. Additionally, on 28 February 2001 Reminyl® received Food and Drug Administration (FDA) approval to be marketed in the US. The current pipeline of 17 projects includes Reminyl* in registration phase in various other markets, SLI 381, Shire's once a day formulation of Adderall* for ADHD which was submitted to the FDA on 3 October 2000 and 8 others that are post Phase II. Shire is actively seeking to acquire further marketed products and development projects to enhance the potential for future growth. Shire's M&A activity has resulted in five completed mergers and acquisitions during the last six years.

On 11 December 2000, Shire entered into an agreement to merge with BioChem Pharma Inc. to form a leading global specialty pharmaceutical company.
More details on this proposed merger and other aspects of the company are available on the Shire website at www.shire.com.

* Trade Mark
References

(A) Cantwell DP. Attention Deficit Disorder: A Review of the Past 10 Years. J Am Acad Child Adolesc Psychiatry. 1996;35:978-987.
(B) The MTA Cooperative Group. A 14-Month Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder.
Arch Gen Psychiatry. 1999;56:1073-1086.
SOURCE: Shire Pharmaceuticals Group plc

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FORT WASHINGTON, PA -- April 1, 2003 -- A study of children with Attention Deficit Hyperactivity Disorder (ADHD) who had previously responded to treatment with methylphenidate demonstrates that once-a-day Concerta(R) (methylphenidate HCl) CII effectively controls ADHD symptoms and maintains a consistent safety profile over one year. The study, an interim analysis of one of the longest studies to date of continued use of a stimulant medication, indicates that children with ADHD are likely to continue to respond to Concerta for up to 12 months. The findings were published in the April issue of the Journal of the American Academy of Child & Adolescent Psychiatry.

The findings also add to the literature in countering some long-standing beliefs about the effect of methylphenidate, the active ingredient in Concerta, as a long-term ADHD treatment. Investigators reported that Concerta did not adversely affect growth (weight and height); did not appear to induce or worsen tics; did not adversely affect vital signs (i.e., blood pressure, pulse); and had no clinically meaningful effect on a wide range of blood tests (i.e., red and white blood cell count, liver function tests). Additionally, despite its extended-release pharmacokinetic profile and long duration of action, Concerta apparently had little impact on parental perception of sleep quality.

"While it is generally agreed that pharmacological treatment of ADHD may be needed for extended periods, few treatment studies of ADHD extend beyond a few months," said study lead author Timothy Wilens, M.D., Director of Substance Abuse Services in the Pediatric and Adult Psychopharmacology Clinics at Massachusetts General Hospital. "This 12-month analysis of a longer-term study establishes the safety and efficacy of Concerta over one year, and addresses some concerns about the effects of long-term methylphenidate treatment on growth (height and weight), tics, vital signs, and sleep quality. Given the chronic nature of ADHD, it is comforting to know that medications such as Concerta continue to work in reducing ADHD and associated impairment."

About the Study

The study was designed to evaluate the effectiveness and tolerability of Concerta administered openly over a period of up to 24 months. It involved one of the largest samples of stimulant-treated ADHD children followed systematically for at least one year.

A total of 407 children, ages six through 13, who had participated in one of the previous efficacy or pharmacokinetic studies for Concerta participated in this multicenter, open-label nonrandomized study.

Subjects were initially assigned to one of three daily dosing levels of once-a-day Concerta (18, 36, or 54 mg) based on their dose in the previous study. Doses could be adjusted upward or downward in 18 mg increments if considered appropriate by the investigator, and participants were permitted to stop taking the medication for weekends or non-school days, or to have medication holidays.

At the beginning of the study, 116 (28.5%) subjects were taking the 18 mg dose, 193 (47.4%) were taking the 36 mg dose, and 98 (24.1%) were taking the 54 mg dose. At the end of treatment (last dose before completing or withdrawing from study), 61 (15.0%), 163 (40.0%), and 183 (45.0%) subjects were taking the 18 mg, 36 mg, and 54 mg doses, respectively. During this period, 39.8% of children had no dose change, 19.7% had dose increases only, and 38.4% of subjects experienced both increases and decreases.

"Increases in dosage of ADHD medications over time is not unusual, and in line with the published literature," explained Dr. Wilens. "The findings from this research suggest that a 20 percent upward titration of Concerta may be appropriate for some children to receive the full benefit of the medication," he added.

Children's ADHD-related behavior in school and at home were rated at various intervals of the study by parents and teachers, using established tools such as the IOWA Conners Ratings Scale. Researchers reported that teacher and parent/caregiver monthly IOWA Conners scores remained relatively consistent throughout the 12-month period.

"The results of this study coupled with results from short-term clinical studies support the usefulness of this once-daily preparation of OROS(r) MPH for ADHD," said Dr. Wilens. "Further studies of Concerta in adolescents, adults, and subgroups of individuals with ADHD, and with concurrent psychosocial treatments are warranted to determine the impact of this long- acting stimulant preparation on the long-term outcome of ADHD." The majority of adverse events reported during the study were judged mild in severity and consistent with the known safety profile of methylphenidate. There were no unusual or unexpected adverse events.

Of the 407 subjects who received study medication, 289 (71 percent) completed 12 months of treatment. Of the 118 subjects who discontinued treatment prior to 12 months, 31 subjects (7.6%) discontinued for lack of effectiveness, 30 of whom were taking the 54 mg dose. Other reasons for discontinuation included adverse events (n=28), lost to follow-up (n=16), noncompliance or protocol violation (n=14), personal reasons (n=11), female reaching menarche (n=6), and other (n=12).

About Concerta

Concerta is an extended-release formulation of methylphenidate for ADHD treatment that is designed to last through 12 hours, with just one morning dose. Concerta uses an advanced OROS(R) extended-release delivery system. The OROS(R) trilayer tablet is designed to release the medication in Concerta in a controlled pattern providing symptom management throughout the day.

Concerta was approved by the U.S. Food and Drug Administration in 2000. It is marketed in the United States by McNeil Consumer & Specialty Pharmaceuticals. For more information about Concerta, call 1-888-440-7903 or visit http://www.concerta.net.

Inside Intersexuality

Hello. My name is Berdache Jordan. Welcome to Inside Intersexuality. I am labeled, medically/biologically, as an Intersexual and I am a "True Hermaphrodite" with a DNA chromosome karyotype of 46 XXXY (mosaic).

In today's society, many Transgendered or Transsexuals refer to themselves as "Intersexuals". But though their bodies may be physically altered, they are still biologically unchanged. These brave people undergo excruciating pain, lengthy treatments and expense to have their external bodies match their inner identity and spirits as women or men. These pre-operative/post-operative sexually altered individuals are often inaccurately perceived and described as hermaphrodites, or "he/she," but they are not Intersexuals or Hermaphrodites.

There are many various "intersexuals" and that term denotes people born apparently in-between what are known as "normal" (average) sexes, within a physical sense (males with male genitalia and females with female genitalia). There are those who appear to be males but are medically/biologically females, and others with female physical attributes that are medically/biologically males. There are also some who's external sex is indeterminant, as well as those of us having appearances of both, externally, and having the DNA chromosome karyotypes of both sexes.

Although I have attributes of both physical sexual extremes labeled "male" or "female", I question, as do many others, that there are two sexes only. In some scientific circles, some maintain there are five sexes. Perhaps as many as 15% of all people, to some degree, are in between "male and female" physically (intersexuals.) This is only physically! There are many millions more who are psychologically, or spiritually, born into the wrong body. There are many more who are spiritually hermaphroditic, whatever their sexual preferences or gender orientation.

This site will explore Human Gender issues, and include Human Sexual issues such as sexual identity that may differ from our apparent sexual packaging and public perceptions of those individuals.

Most importantly though, this will be a support site for Intersexuals and Parents of Intersexuals; a place where we can gather to discuss our concerns, fears, and everyday life.

There is also information for those curious about this rare physical condition. Of the great deal "known" about some causes of intersexual births, much is still only conjecture of an anomaly. Many intersexuals and medical professionals are deeply concerned with this subject, and with the present medical practice of surgically assigning a single sexual appearance to babies born intersexuals. This is done without the knowledge or consent or preference of the child, who is affected for life. In some cases, it is done without the parent's knowledge or consent.

Again, welcome from
Just an "other"...

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How to Help Yourself if You Are Depressed

Depressive disorders make one feel exhausted, worthless, helpless, and hopeless. Such negative thoughts and feelings make some people feel like giving up (Suicide Hotline Phone Numbers). It is important to realize that these negative views are part of the depression and typically do not accurately reflect the situation. Negative thinking fades as treatment begins to take effect. In the meantime:

• Set realistic goals and assume a reasonable amount of responsibility.
• Break large tasks into small ones, set some priorities, and do what you can as you can.
• Try to be with other people and to confide in someone; it is usually better than being alone and secretive.
• Participate in activities that may make you feel better.
• Mild exercise, going to a movie, a ballgame, or participating in religious, social, or other activities may help.
• Expect your mood to improve gradually, not immediately. Feeling better takes time.
• It is advisable to postpone important decisions until the depression has lifted. Before deciding to make a significant transition--change jobs, get married or divorced--discuss it with others who know you well and have a more objective view of your situation.
• People rarely "snap out of" a depression. But they can feel a little better day by day.
• Remember, positive thinking will replace the negative thinking that is part of the depression and will disappear as your depression responds to treatment.
• Let your family and friends help you.

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Psychological treatment of depression (psychotherapy) can assist the depressed individual in several ways. First, supportive counseling helps ease the pain of depression, and addresses the feelings of hopelessness that accompany depression. Second, cognitive therapy changes the pessimistic ideas, unrealistic expectations, and overly critical self-evaluations that create depression and sustain it. Cognitive therapy helps the depressed person recognize which life problems are critical, and which are minor. It also helps him/her to develop positive life goals, and a more positive self-assessment. Third, problem solving therapy changes the areas of the person's life that are creating significant stress, and contributing to the depression. This may require behavioral therapy to develop better coping skills, or Interpersonal therapy, to assist in solving relationship problems.

At first glance, this may seem like several different therapies being used to treat depression. However, all of these interventions are used as part of a cognitive treatment approach. Some psychologists use the phrase, cognitive-behavioral therapy and others simply call this approach, cognitive therapy. In practice, both cognitive and behavioral techniques are used together.

Once upon a time, behavior therapy did not pay any attention to cognitions, such as perceptions, evaluations or expectations. Behavior therapy only studied behavior that could be observed and measured. But, psychology is a science, studying human thoughts, emotions and behavior. Scientific research has found that perceptions, expectations, values, attitudes, personal evaluations of self and others, fears, desires, etc. are all human experiences that affect behavior. Also, our behavior, and the behavior of others, affects all of those cognitive experiences as well. Thus, cognitive and behavioral experiences are intertwined, and must be studied, changed or eliminated, as an interactive pair.

Self-evaluation

Self-evaluation is a process that is ongoing. We evaluate how we are managing life tasks, and we evaluate whether we are doing what we should, saying what we should, or acting the way we should. In depression, self-evaluation is generally negative and critical. When a mistake occurs, we think, "I messed up. I'm no good at anything. It's my fault things went wrong." When someone is depressed, he/she tends to take responsibility for everything that goes wrong, and tends to give others credit for things that turn out fine. Psychologists assume that self-evaluation, in depressed individuals, is too critical, and feeds low self-esteem and a sense of failure.

Evaluation of Life Experiences

When depressed, a person will focus on minor negative aspects of what was otherwise a positive life experience. For example, after a vacation at the beach, the depressed person will remember the one day it rained, rather than the six days of sunshine. If anything goes wrong, the depressed person evaluates the entire experience as a failure, or as a negative life experience. As a result, memories are almost always negative. This is reflective of unrealistic expectations. Nothing in life ever works out just as you want. If we expect perfection, we will always be disappointed. Psychologists help you to develop realistic expectations about life, and help you determine what you need versus what you want. After all, most of the things that don't work out are little things. And even when important problems develop, we can either resolve the problem, or regroup, recover, and start again, with hope for a better future. In depression, the hope is missing.

Pessimistic Thinking

Pessimistic thinking does not cause depression, but it appears to be easier to become depressed if you tend to view the world with considerable pessimism. After all, pessimism is a tendency to think that things won't work out as you wish, that you won't get what you want. Pessimism feeds the negative cognitive distortions and self-talk. On the other hand, optimism appears to create some protection from depression.

Hopelessness is a central feature of depression, along with helplessness. If you view your world as bad, filled with problems, and don't think you can do anything about the problems, you will feel helpless. If you don't believe your life will improve, if you think the future is bleak, then you will begin to feel hopeless. Pessimism encourages these negative assessments of your life. Optimism prevents you from reaching those conclusions. In fact, psychologists have researched ways to learn how to be more optimistic, as a way of fighting depression.

Summary of Cognitive Psychotherapy Approach

First, remember that we cannot present cognitive psychotherapy in one web page, or in a few paragraphs. But, the essence of cognitive therapy is the assumption that irrational thoughts and beliefs, overgeneralization of negative events, a pessimistic outlook on life, a tendency to focus on problems and failures, and negative self assessment, as well as other cognitive distortions, promote the development of psychological problems, especially depression. Psychologists use cognitive therapy to help you identify and understand how these cognitive distortions affect your life. Cognitive therapy helps you to change, so that these issues will not rule your life. If you are feeling overburdened, that life is not working for you, and you don't know what to do next, talk to someone who can help, consult a psychologist.

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Clinical depression is readily treatable with counseling and medication. Many people suffer needlessly from depression because they don't seek treatment. They may feel that depression is a personal weakness, or try to cope with their symptoms alone.

If you are feeling depressed, and have been for over a month, you should consider seeking professional help from a gay-positive (or trans-supportive) therapist, doctor, psychiatrist, or other health care provider. There are plenty of mental and other health professionals who will support you and guide you towards being a happy and healthy GLBT person-you deserve nothing less. If you are looking for a gay-supportive counselor, ask friends for referrals or call a local GLBT-friendly mental health agency.

A study performed by the National Institutes of Mental Health showed that after 16 weeks of psychotherapy, 55% of those with mild to moderate depression reported significant improvement. Different people react in different ways to various types of counseling, but cognitive therapy--in which you learn to recognize and replace depressive thinking--can be particularly effective for people experiencing depression.

When there is a chemical component to depression, antidepressant medication can help to correct the chemical imbalance (low levels of brain serotonin and norepinephrine). People with moderate to severe depression are most likely to benefit and improve from the use of medication. Many different types of antidepressants have been developed-if one doesn't work for you, another one probably will. Some studies have shown that combinations of antidepressant drugs and good psychotherapy may be the best approach.

Depression and suicide

Sometimes people become so depressed that they think about harming or killing themselves. These thoughts and actions can be "passive"--like not wanting to wake up in the morning or wishing to disappear, as well as "active"--like taking pills, cutting oneself or shooting oneself. When suicidal thoughts or acts are present, it's a good indication that the person may be struggling with a very serious depression.

If you are thinking about hurting yourself or have laid out a suicide plan, please get help immediately. Call a friend, your doctor or your local crisis telephone service. You are not alone and although it may be hard to imagine right now, these feelings will pass and you will be glad you did seek help. If you're in King County and want to speak with someone right away, call the Crisis Clinic at 206-461-3222 any time of the day or night.

If you have a friend or loved one who is thinking about suicide, talk to them about it openly and help them get some professional help as quickly as possible. Asking about suicide does not make it more likely that a person will harm themselves--often people find it a great relief to finally have someone to talk to.

Tips for handling depression

• Try to accept your depression as an illness. You cannot will the depression away.
• Try to do things that you enjoy--visit friends, get a massage, take a class--to get your mind off what may be contributing to the depression and to focus on things that help you feel better.
• Delay any big decisions or changes that involve work, love or money until you feel better.
• It's common to be forgetful when you're depressed, stressed out or anxious. Take notes and make lists. Your memory will improve when you feel better.
• Waking through the night is very common. It's better to get out of bed until you feel sleepy again. Repeated awakening in the early morning without being able to return to sleep easily is a sign that medical evaluation is needed.
• Mornings are often the worst time. The day usually gets better towards evening.
• Avoid being home alone for long periods--the depressive thoughts can get worse when no one is around.
• Get outside at least once a day for a walk. Light to moderate exercise of any kind can be very helpful to your recovery.
• Don't try to "medicate" yourself with alcohol, marijuana or other drugs. These drugs may actually make you more depressed than you were to begin with.

What do if someone you love is depressed

It can be difficult to be around a friend who is depressed. You may feel helpless and sometimes angry, particularly if the person is irritable and doesn't respond when you reach out. Keep reminding yourself that the person is ill, and doesn't mean to be hurtful or unresponsive.

You can't relieve clinical depression with love alone any more than you can cure heart disease or diabetes with just love. People who are depressed need professional help, and some require medication.

On the other hand, social support improves treatment results in many serious illnesses including depression. Reach out to your depressed friend so that he or she knows that you care. Call. Send affectionate notes. Invite the person to dinner, movies, ball games, parties, and other events. But keep your expectations low. Even if your friend doesn't respond, you can be sure that he or she appreciates your attempts.

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It's a catharsis for McGreevey. But what about those left behind?

(Aug. 23, 2004) -- As Cathy Morton watched Gov. James McGreevey's televised confession last week, she felt drawn to his wife, Dina, who stood at his side with a pained half smile frozen on her face. "I've been there," says Morton, who says she discovered her husband cruising gay Web sites five years ago. "She may not feel lucky now," says Morton, who is now divorcing, "but at least he admitted the truth and took responsibility. That's something."

Few women have to endure the disclosure at a news conference, but Dina Matos McGreevey is hardly alone. Nationwide there are nearly 2 million "straight spouses" whose husbands and wives have come out of the closet, often after decades of marriage, says Amity Pierce Buxton, whose book "The Other Side of the Closet" examines the phenomenon. In most cases, says Buxton, wives or husbands are stunned by the revelation; in about a third, wives or husbands have an inkling that their partner is struggling, but "don't want to face the elephant in the room."

The wave of midlife coming-out crises is explained in large part by growing social acceptance. Gays and lesbians of McGreevey's generation were more likely to conform to the social pressure to marry—especially if they wanted children—than are young homosexuals today. As they approach middle age and watch their kids leave for college, many no longer see a reason to remain in their heterosexual marriages.

But while those coming out can find acceptance, even celebration, in their newfound identities, the partners and children left behind are often devastated. "The gay community is portrayed as courageous, but no one shows the families who are left to pick up the pieces," says Flo Kubes, whose wife left him for a woman in their congregation after 20 years of marriage. Kubes, a pastor in a conservative community in Minnesota, lost his job, he says, as a result (church elders felt the scandal was too distracting). The couple's teenage son was hospitalized for depression. Kubes says he struggled for months to find emotional help before joining Buxton's online support group, the Straight Spouse Network (ssnetwk.org). Many wives of gay husbands are terrified they've been exposed to AIDS. Kathy Rockel, whose husband came out to her shortly before his 50th birthday, says she dreaded telling a clinic worker in her small Colorado town why she needed an AIDS test. (Both spouses tested negative.)

Late last week the chat room was abuzz with speculation—and sympathy—for Dina McGreevey. What did it feel like to hear the truth while standing on a stage? Would she stay—or would she go? Who was helping her while attention was focused on her husband? And there were more than a few invitations for her to log on and find a virtual shoulder to lean on.

© 2004 Newsweek, Inc. By Karen Breslau and Debra Rosenberg

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(July 29, 2004) -- Regina Griggs, executive director of Parents and Friends of Ex-Gays and Gays, sites the work of the National Association of Research and Therapy of Homosexuality and psychiatrist Robert Spitzer to back her claim that gays can be changed to heterosexuals ("Homosexuality needs change, not marriage," July 22). Anyone who believes her claim should read Wayne Besen's new book, "Anything but Straight: Unmasking the Scandals and Lies Behind the Ex-Gay Myth." Besen's four years of well-documented research expose unscientific research, false statistics, and unsuccessful results of "ex-gay ministries" to discredit NARTH and Dr. Spitzer.

Real people are being harmed by the "ex-gay ministries" and the false belief that gays can change their sexual orientation. The American Psychiatric Association says, "The potential risks of 'reparative therapy' are great, including depression, anxiety, and self-destructive behavior." The APA is joined by all the leading medical associations in condemning "ex-gay ministries" as harmful practices that can cause severe emotional damage. In despair some gays resort to suicide after unsuccessful attempts to change and adapt to an adverse society.

Keeping gays in the closet hurts everyone--not just gays. Many marriages end because a gay husband or wife can no longer live a lie. Spouses are devastated. Children are confused. Friends and relatives are enraged from the fallout. I wish that Regina Griggs and others who reinforce homophobia could feel the pain, alienation, and self-hatred that they have caused. Some day I hope they will be held accountable.

Gays have been around for as long as recorded history. Treating them with disdain and intolerance is not going to make them go away. Accept gay people as they are and grant them full human and civil rights. Allow them to live honestly and with dignity and respect. We all benefit when no one is excluded. "Homosexuality is neither mental illness nor moral depravity. It is simply the way a minority of our population expresses human love and sexuality"--American Psychological Association Statement on Homosexuality.

Cris Elkins

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