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    #46
    http://www.accessdata.fda.gov/script....cfm?fr=56.102

    This treatment does not fall under IRB requirements as detailed in the regulation you quoted PDnemisis. The physicians published a case report, which is a study of the progress of an individual who received marketed, approved treatment(s). These are exempt from IRB approval as there is no control group, no non-approved therapies, nor any pre-post method of comparison.

    This is what I do for a living. I am very familiar with when an IRB is required and when it is not. I read the paper; it was not required based on the description of the procedures. Also, NO medical journal would publish information that was obtained in violation of FDA regulations. I peer review for many medical journals and that is the absolute first thing you check as a reviewer.

    So, to summarize: you are flat wrong about the regulations. ETA: you obviously still disagree with what they did, but they did not violate GCP (good clinical practice) guidelines so your claim that "the rules were not adhered to" is incorrect. I respect your right to disagree with what they did however. That is your right.
    Wife of Chad (C4/5 since 1988), mom of a great teenager

    Comment


      #47
      Two people I know personally who currently sit or have just until very recently sat on IRB boards disagree with you.

      Neither consider the the treatment Ashley received to fall within what the treatment was marketed and approved for.

      If they decide to go public with their letters they posted on a private listserv I belong to I will publish them here.
      Ashley is a little girl worth knowing about:http://www.ashleyx.info

      Comment


        #48
        Unjustifiable Non-therapy

        A response to Gunther & Diekma (2006), and to the issue of growth attenuation

        For young people on the basis of disability

        From

        The Board of Directors of the American Association on Intellectual and

        Developmental Disabilities (formerly known as the American Association on Mental Retardation)

        As leaders of the American Association on Intellectual and Developmental Disabilities, the oldest multidisciplinary association in the United States representing professionals within the field of intellectual and developmental disabilities, we have great sensitivity to the concerns facing parents of children with profoundly disabling conditions. They indeed face many extraordinary challenges as they strive to raise their children, and they should be provided with the supports and services they need to ensure that their children, as any others, have opportunities to achieve all that life has to offer. Naturally, these services and supports include medical and habilitation therapies. We as a society should be supportive of innovative approaches to treatment, but we should also demand a thorough evaluation of potential benefits and balance these against carefully considered risks.

        Gunther and Diekema1 have described a controversial intervention they provided to Ashley, a 6-year-old girl with profound and multiple impairments, which they refer to as “growth-attenuation therapy.” This intervention, approved and apparently promoted by the parents, consisted of high doses of estrogen to bring about a permanent attenuation in her size. Together with a hysterectomy and removal of both breast buds, the intention was to minimize the likelihood of a future out-of-home placement by maximizing the future comfort of this child and

        ensuring a manageable care-giving burden for parents who wanted very much to maintain their daughter in their loving environment.

        The ultimate and worthy goal in this case was to ensure a higher quality of life for Ashley through the avoidance of an eventual placement outside of her family home. As individuals and as an organization, we endorse policies and actions that help families to rear their children with intellectual and other developmental disabilities at home, nurturing their capabilities as well as coping with their impairments. We applaud the efforts of the many caring professionals who are engaged in providing extraordinary care to children with intensive and pervasive support needs and who continue to meet those needs throughout their adult lives. We also recognize the many challenges faced by physicians as they weigh with families the benefits versus costs of various treatment options and struggle with the complex ethical concerns that can arise. Gunther and Diekema, as well as Brosco and Feudtner2, discuss some these issues in the context of growth-attenuation therapy and seek responses from the field to inform future practice. As the current leadership of the former American Association on Mental Retardation and now the American Association on Intellectual and Developmental Disabilities, we view growth-attenuation as a totally unacceptable option. We share the concerns raised by Brosco and Feudtner, and we will add our own to theirs.

        In Gunther’s and Diekema’s judgment, growth attenuation offers reasonable expectation of improved quality of life in this case. However, the history of the medical establishment’s involvement in exactly these types of quality of life issues has, as noted by Brosco and Feudtner, led to the support of some very regrettable past policies (e.g., involuntary sterilization, lifelong involuntary institutionalization). All physicians must recognize that the decisions they make will be colored by their subjective views of the status of their patients. In stating that there will be no significant future improvement from her baseline, Gunther and Diekema reveal that they and their colleagues recognize little potential for growth and development of this six year old child. It is not then surprising that they find it “hard to imagine how being smaller would be disadvantageous to a person whose mental capacity will always

        remain that of a young child” (p. 1016). The abundant evidence that all children are able to learn and that the cognitive capabilities of children with severe motor impairments can be grossly underestimated were not mentioned, and while we do not pretend to be as familiar with this situation as the treating physicians, we think that extant case histories of people with cerebral palsy incorrectly diagnosed as having profound mental retardation should be recognized and discussed.

        Brosco and Feudtner questioned the efficacy of the procedures described by Gunther and Diekema, indicating that there is no guarantee that growth attenuation and hysterectomy will effectively delay out-of-home placement. We agree. Further, because the future development of any six year old child will depend on many factors, the medical, social and programmatic needs of the adult Ashley will become cannot be anticipated with certainty. Over recent decades, the principle has been firmly established that an ever-improving future for individuals with extensive impairments is achievable, and in fact there may be adult programs evolving that will offer these parents options they are not now able to consider.

        Brosco and Feudtner next noted that risks of harm from this “heavy-handed” manipulation are unknown for this population, and this is an issue that begs for further amplification. Estrogen has hugely important actions. Even a cursory search of the literature shows that it influences things as wide ranging as immune system function and bone growth3 (e.g., Weitzmann and Pacifici, 2006), neuroprotection4 (e.g., Bryant, Sheldahl, Marriott, Shapiro and Dorsa, 2006), and hair follicle physiology5 (Ohnemus, Uenalan, Inzunza, Gustafsson and Paus, 2006). Further, estrogen is metabolized within the central nervous system throughout life, and the negative effects of its depressed bioavailability on aging are well documented. Thus, this artificial manipulation may have many unforeseen consequences, and while optimism has its place, there is ample reason to suspect that some of these consequences will be deleterious.

        Brosco and Feudtner discussed the precedent setting potential for growth attenuation that can lead to misuse, and that the intervention does not really address the core problems faced by families and our society regarding services and supports to affected individuals. These are additional excellent points with which we concur. However, they seemed to accept two critical assumptions that we do not. First, in discussing the potentially detrimental effects of growth attenuation, they argue that imposition of small stature might not be a concern if we truly accept the position of disability rights advocates that there is value in every human life and that the worth of a person goes beyond physical appearance. We certainly view people with disabilities as valued members of our society, but we fail to see anything in the disabilities rights movement to justify imposing constraints on anyone’s development. To argue this point grossly misrepresents the views of the disability community and turns logic on its head.

        Second, Brosco and Feudtner seemed to implicitly accept the idea that growth attenuation is in fact a type of therapy. We question this critical premise. Given that therapy is intended to address a condition of a patient, the target in this case would have to be the growth and maturation expected as a consequence of Ashley’s normal development. While there are many other treatments that target aspects of physical appearance, these seem qualitatively different from the present case. Although the closest parallel would be the past exposure of tall young women to high doses of estrogen to limit their height, we see this as a considerable stretch. It seems a bit desperate to refer to a practice that fell out of favor years ago (and would be viewed with extreme skepticism today) in defending these procedures, but even in those past cases the intervention was provided with the assent of the patients and to address specific desires.

        Clearly, assent was not obtained from this child, and there was no way to assess her willingness to have her body altered irreversibly. Brosco and Feudtner argued persuasively that growth attenuation has to be considered a procedure that has unknown risks and permanent consequences.

        Because there was no urgency in this case, a very substantial burden of proof of benefit should have been imposed before moving forward. We see no such evidence of benefit, and despite description of a committee review process (apparently for future cases), there was no mention of including an independent legal advocate for the child or any other professional with explicit expertise in disability rights and autonomy, nor was it apparent that anyone participating in the process would be knowledgeable about the ever expanding options for in-home supports and services. The lives of parents of children with severe disability are profoundly affected, and these individuals are asked to shoulder exceptional responsibilities for care-giving. They should be supported as they strive to meet the extraordinary needs of their children, and we as a society must acknowledge and value their efforts. We must provide them with the supports and services they need to succeed in what Brosco and Feudtner rightly refer to as their “most admirable of undertakings.” However, growth attenuation of their children should not be included as an option. Under our law, parents are vested with the responsibility for making health care decisions for their minor children, but parental prerogatives are not absolute. Children have their own distinct rights and protections afforded them as individuals established in ethical principles and legal statutes. These rights should be of central relevance in the current situation, yet they did not seem to receive the attention they deserved.

        With a damning combination of uncertain benefits and unknown risks, growth attenuation as described by Gunther and Diekema is bad medicine, but this practice has even more troubling implications. By extension, if weight ever becomes a difficulty due to age-associated loss of strength for the parents (rather than obesity of the child), then the rationale would suggest that bariatric surgery or severe restriction in caloric intake would be a form of therapy. If that proves insufficient, the goal of reducing the size of the child could be addressed by “amputation-therapy,” justified by the fact that the patient would never be ambulatory in any event.

        Should the child develop behaviors that increased the stresses of care-giving, then it should be perfectly acceptable to prescribe whatever dosage of psychoactive medication would be necessary to bring relief to the caregivers.

        It seems painfully obvious that medical practice for an individual can rapidly degenerate if the anxieties of the parents regarding as yet unclear future issues replace the medical best interest of the child as the primary focus, even with the noblest of intentions of all parties involved. We see an enormous potential for abuse here, and given the well-documented history of mistreatment, neglect and devaluation of this population, we are stunned and outraged by the very fact that the relative merits of growth attenuation could, in 2006, be a topic for serious debate in this forum. As described by Gunther and Diekema, it distorts the concept of treatment and devalues the patient’s personhood. While references to slippery slopes should be made with great care, we believe that this practice, if judged acceptable, will open a doorway leading to great tragedy. This door is better left closed.

        AAIDD Board of Directors:

        Hank Bersani, Jr. PhD, President

        David A. Rotholz, PhD, President-Elect

        Steven M. Eidelman, Vice President

        Joanna L. Pierson, PhD, Secretary/Treasurer

        Valerie J. Bradley, Immediate Past President

        Sharon C. Gomez, Member-At-Large

        Susan M. Havercamp, PhD, Member-At-Large

        Wayne P. Silverman, PhD, Member-At-Large

        Mark H. Yeager, PhD, Member-At-Large

        Diane Morin, PhD, Canadian Member-At-Large

        Michael L. Wehmeyer, PhD, Member-At-Large

        Bernard J. Carabello, Presidential Advisor

        M. Doreen Croser, Executive Director

        References

        1. Gunther D, Diekema, D. Attenuating growth in children with profound developmental disability: A new approach to an old dilemma. Arch Pediatr Adolesc Med. 2006; 160: 1013–17.

        2. Brosco J, Feudtner C. Growth attenuation: A diminutive solution to a daunting problem. Arch Pediatr Adolesc Med. 2006; 160: 1077–78.

        3. Weitzmann, M., & Pacifici, R. Estrogen regulation of immune cell bone interactions. Ann N Y Acad Sci. 2006; 1068: 256-74.

        4. Bryant, D., Sheldahl, L., Marriott, L., Shapiro, R., & Dorsa, D. Multiple pathways transmit neuroprotective effects of gonadal steroids. Endocrine. 2006; 29: 199-207.

        5. Ohnemus, U., Uenalan, M., Inzunza, J., gustafsson, J., & Paus, R. The hair follicle as an estrogen target and source. Endocr Rev. 2006; 27: 677-706.
        Ashley is a little girl worth knowing about:http://www.ashleyx.info

        Comment


          #49
          What you posted is your group's response. There is no requirement to file with an IRB for off label use of anything. For example, the antidepressant Cymbalta can be prescribed by any physician for any reason even though the labeled / indicated claim is for major depression disorder. A doc can prescribe it for toe fungus he s/he wants to. If it is marketed and approved, you can do with it what you wish unless you are formally testing it for another specific purpose or are in the confines of an investigational study - of which this was not. It is a case report.

          Off label usage does not require an IRB approval. The usage in this case was 100% off label. That is irrelevant.
          Wife of Chad (C4/5 since 1988), mom of a great teenager

          Comment


            #50
            A fundamental and universal misconception about the treatment is that it is intended to convenience the caregiver; rather, the central purpose is to improve Ashley’s quality of life. Ashley’s biggest challenges are discomfort and boredom; all other considerations in this discussion take a back seat to these central challenges. The “Ashley Treatment” goes right to the heart of these challenges and we strongly believe that it will mitigate them in a significant way and provide Ashley with lifelong benefits.
            Unlike what most people thought, the decision to pursue the “Ashley Treatment” was not a difficult one. Ashley will be a lot more physically comfortable free of menstrual cramps, free of the discomfort associated with large and fully-developed breasts, and with a smaller, lighter body that is better suited to constant lying down and is easier to be moved around.
            Ashley’s smaller and lighter size makes it more possible to include her in the typical family life and activities that provide her with needed comfort, closeness, security and love: meal time, car trips, touch, snuggles, etc. Typically, when awake, babies are in the same room as other family members, the sights and sounds of family life engaging the baby’s attention, entertaining the baby. Likewise, Ashley has all of a baby’s needs, including being entertained and engaged, and she calms at the sounds of family voices. Furthermore, given Ashley’s mental age a nine and a half year old body is more appropriate and more dignified than a fully grown female body.
            http://ashleytreatment.spaces.live.com/

            This is a quote from the family's website. I think they are acting in their daughter's best interest and attempting to provide her a quality of life. If you look at the pictures, she is definately being treated as a part of the family and I think that is all that anyone can ask.
            T12-L2; Burst fracture L1: Incomplete walking with AFO's and cane since 1989

            My goal in life is to be as good of a person my dog already thinks I am. ~Author Unknown

            Comment


              #51
              Originally posted by antiquity
              I wasn't making an inference but you certainly were by assuming that I possess advanced knowledge of her thoughts and was seeking clarification just for the heck of it.
              So sue me for giving you the benefit of the doubt. I'm guilty of thinking you were smart enough to consider Betheny's statement IN CONTEXT. She talked about "quality of life", "joy" and specifically said that she doesn't "condone butchery of the disabled." You took one word out of an entire post and ran with it. It seemed to be a calculated move on your part. I was wrong. OK.

              Honest question. Sorry if it made you uncomfortable
              I don't see the need for an apology and nothing you've said has made me uncomfortable (an odd choice of words). Now that we've cleared all that up, let's move on.

              C.

              Comment


                #52
                Nothing but judgment in most of the posts in this thread.

                There is nothing but judgment and imposition of one's personal experience and beliefs about what might be better/greater "quality" of life unto another human being.

                There isn't what some seem to believe is some attempt to improve QOL, by changing conditions to help make a child's life better. There is, however, an effort (and act committed) to change the child, to accommodate all those around her, including making others' lives easier. There is acknowledgment of the environment and society in general, not being easy and pretty difficult and limiting for people living with disabilities, conditions which can in ways be further 'disabling' to one without full, "normal" function.
                But, to further disable another's body to accommodate the world and ease "discomfort and boredom"? Perceived boredom. Dismember a child's body to accommodate perceived boredom?

                To talk about a child being unaware and not being conscious of "loss" (enough to morn whatever was taken away), is selfishly imposing one's own idea(l)s onto another and further, not even giving that person an opportunity for potential or experience.

                Is function and actual experience necessary or required to preserve a body?

                If a male child became SCI without ever experiencing sex, would it be ok then to remove their penis and give them a SP, since they will never mourn the loss of using their penis in a ("normal") sexual way?
                If a child became a high quad only able to move the head, with bleak prognosis of ever using any part of the body ever again (excepting a "cure"), would it be ok to amputate the legs to make life easier for the caregivers? Would it be ok to amputate any part of the body that causes pain, or rather, pre-empt possible pain, as perceived by the caregivers/legal guardians?

                People seem quick to acquiesce to making another more disabled and prevent potential (if it isn't spinal cord related?), and not make effort (in thought, even) to help make her more "whole" by demanding any change - be it environmental/social/policy, to Cure.

                There is some distinguishment being made between those disabled via SCI/D, and others living with varying disabilities, many being congenital.

                "We aren't disabled like them". "They don't know what it's like to be normal"....

                Is it any wonder that non-SCI related disabled person's and groups are not so quick to jump on the cure bandwagon?

                With the antiquated and archaic thoughts and beliefs expressed in this thread and judgments made about disabled persons (be they consciously made or not) by SCI disabled persons lacking any empathy, it is not surprising that disabled people/organizations, who've worked and fought for decades for the rights of disabled persons to live as much as possible, independent and autonomous lives, and to be given the same opportunities to live their human potential as any other person, are not as quick to jump on.

                Cure? Cure what? Whom? Why would non-SCI/D jump on board to support something so disingenuous and selfish, as what's been expressed here?

                The posts expressed here are not only disturbing, but disgusting. They are also the very type of sentiment that has kept disabled persons hidden away from society and institutionalized.

                ...for their own good.
                Last edited by chick; 11 Jan 2007, 7:12 PM.

                Comment


                  #53
                  Originally posted by chick
                  Nothing but judgment in most of the posts in this thread.

                  <snip, blah, blah, blah snip snip snip snip snip SNIP>

                  The posts expressed here are not only disturbing, but disgusting. They are also the very type of sentiment that has kept disabled persons hidden away from society and institutionalized.

                  ...for their own good.
                  Please compare sentence one with the second the last sentence in your post. Pot? Meet kettle. Kettle? Meet pot.
                  Wife of Chad (C4/5 since 1988), mom of a great teenager

                  Comment


                    #54
                    As expected. You missed the point.

                    Originally posted by zillazangel
                    Please compare sentence one with the second the last sentence in your post. Pot? Meet kettle. Kettle? Meet pot.
                    I am disgusted by the opinions expressed here and will/have made judgment.

                    You can continue to judge disabled persons as less worthy of potential. So be it.

                    You are bothered by my judgment of that, I presume? As I am disgusted by your, and others, judgment against this disabled child and disabled persons as a whole.

                    I'm cool with that.

                    Comment


                      #55
                      Originally posted by chick
                      As expected. You missed the point.

                      I am disgusted by the opinions expressed here and will/have made judgment.

                      You can continue to judge disabled persons as less worthy of potential. So be it.

                      You are bothered by my judgment of that, I presume? As I am disgusted by your, and others, judgment against this disabled child and disabled persons as a whole.

                      I'm cool with that.
                      Oh yes, I am uber cool with thinking disabled people are pathetic useless pieces of shit. Obviously.

                      As expected. You missed the point.
                      Wife of Chad (C4/5 since 1988), mom of a great teenager

                      Comment


                        #56
                        You wish and choose to make this personal zilla?

                        Whatever your motivation and intention, carry on without me.

                        Ta.

                        Comment


                          #57
                          Originally posted by chick
                          Nothing but judgment in most of the posts in this thread.
                          Yes, and? Why do you start your long, judgmental post with this sentence? It sounds like you disapprove of people making judgments about others (which is in itself a judgment), but then you go on to express quite a few conclusions of your own.

                          Personally, I think it's silly when people claim to be "nonjudgmental" and assert that as a positive thing. So I'm not against you expressing your opinion in this fashion. I'm just wondering about the hypocrisy of condemning something while in the act of doing it.

                          Oh, and out of curiousity...

                          I am disgusted by your, and others, judgment against this disabled child and disabled persons as a whole.
                          Is it not possible to judge people and situations on a case-by-case basis? Saying that I don't like vanilla ice cream doesn't mean that I don't like ice cream as a whole.

                          C.

                          Comment


                            #58
                            Originally posted by Tiger Racing
                            Personally, I think it's silly when people claim to be "nonjudgmental" and assert that as a positive thing. So I'm not against you expressing your opinion in this fashion. I'm just wondering about the hypocrisy of condemning something while in the act of doing it. .
                            My first sentence is a statement regarding the hypocrisy I see in this thread, not the mere act of making judgment.

                            Where did I claim to be "nonjudgmental"? I actually claimed otherwise.

                            Please take time to read my follow-up post.

                            Comment


                              #59
                              Originally posted by chick
                              You wish and choose to make this personal zilla?

                              Whatever your motivation and intention, carry on without me.

                              Ta.
                              Well yeah, I am making it personal. I rarely take having my opinion called "disgusting" as just making conversation. So thanks, I will clarify my thoughts on this without another retort from you (please see bold above).
                              Wife of Chad (C4/5 since 1988), mom of a great teenager

                              Comment


                                #60
                                Still not comfortable with what they have done to this girl. I was abhorred to read about removal of the appendix when there was only a 5% chance of it rupturing ... but I read on their site that she would be unable to communicate the pain so I understand the concern. There are contradictions though ... later on the mother writes that she appeared to have minimal discomfort after the surgeries.

                                The website states that the child is 9yrs old but has bones of a 15yr old after the estrogen treatments. Would she not be prone to bone density loss (even moreso now) and pressure sores?

                                The saddest part -
                                "We are currently near the limits of our ability to lift Ashley at 65 pounds. Therefore, an additional 50 pounds would make all the difference in our capacity to move her. Furthermore, other than her Mom and Dad the only additional care givers entrusted to Ashley’s care are her two Grandmothers, who find Ashley’s weight even more difficult to manage. We tried hard and found it impossible to find qualified, trustworthy, and affordable care providers."

                                Although, I completely agree with removal of her uterus having suffered some horrible menstrual cramps myself.

                                How do you tell, for a child who can't communicate, that they're bored?

                                I'm still reading the website. I'm not sure how I feel about what they did to her ... in treating everyone compassionately as a person and if Ashley could communicate with a normal brain function and personality evolvement - what would she say to her parents after this? That is what worries me ...
                                Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

                                T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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