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Re: Lupron letter writing paying off!!
From: anonymous (anonymous@obgyn.net)
Thu Nov 27 02:30:23 2008
Niki, great, great work. I have been on lupron and just recently made
the decision to quit after doing just a little bit of research. I did
not know many of the things in the article, i just want to cry, but its
all making sense now. Thank you for posting this.
At Wed, 26 Nov 2008, Niki wrote:
>
>This was the cover story on National Womens Health Network!!!!!!
>
><http://www.womenshealthnetwork.org/newsletter/article1.cfm?newsletterar\
>ticles_id04>
>
>Here is the article in case you can't get the link to work:
>
>Women's Health Activist November December 2008: Cover Story
>Lupron® – If It Kills Prostate Cancer, What Does It Do To
>Women's Health?
>
>By Susan K. Flinn, MA
>
>Here at the Network, we often receive emails or calls from women seeking
>health care information about specific procedures or tests. Something
>different's been happening recently, however: we've received
>several messages from women asking the Network to explore the safety of
>a drug commonly used in fertility treatments: Lupron® (leuprolide
>acetate). This drug was originally developed for advanced prostate
>cancer patients, but is now commonly used to treat women with
>endometriosis and fibroids, and to aid assisted reproduction procedures.
>Lupron® is a Gonadotropin-Releasing Hormone Analog/Agonist (GnRH);
>these drugs shut down the pituitary gland, thereby reducing the amount
>of testosterone produced by men, and estrogen produced by women. For
>women, this causes the rapid and artificial onset of menopause –
>potentially with incapacitating and long-lasting effects.
>
>"My own story is that after taking Lupron [for endometriosis] I now
>have bone loss, severe bone and joint pain requiring heavy painkillers
>to get out of bed, chest pain, tachycardia, fibromyalgia and horrible
>memory loss, hair loss and weight gain. Prior to Lupron I ran and boxed
>everyday. I was healthy even though endometriosis caused significant
>pain. It has now been a year since my Lupron treatments and my life is
>in medical shambles."
>
>The women contacting the Network relate very similar experiences: they
>were healthy but -- after using Lupron® – they report having lost
>their health, their jobs, and more. While only a small percentage of
>women seem to have such a severe reaction, there is no way to predict
>who will experience these frightening and debilitating side-effects. Nor
>does there seem to be any interest on the part of either the Food and
>Drug Administration (FDA) or Lupron®'s manufacturer to further
>investigate the drug's safety or adverse events. One woman who wrote
>to the Network about her experiences asked, "Who is watching out for
>us?"
>
>The FDA reports that, as long ago as 1999, it had received adverse drug
>reports about Lupron® from 4,228 women and 2,943 men1. These side
>effects included: tingling, itching, headache and migraine, dizziness,
>severe joint pain, difficulty breathing, chest pain, nausea, depression,
>emotional instability, dimness of vision, fainting, weakness, amnesia,
>hypertension, muscular pain, bone pain, nausea/vomiting, asthma,
>abdominal pain, insomnia, chronic enlargement of the thyroid, liver
>function abnormality, vision abnormality, and anxiety, and others2. In
>325 of these cases, the women required hospitalization; 25 women died1.
>At the time, the FDA said that it did not have enough staff capacity to
>assess any causal effect in these cases.
>
>Lupron®'s original manufacturer, Takeda-Abbott Pharmaceuticals
>(TAP) Pharmaceuticals, has stated that the drug's side effects are
>temporary and should last no longer than six months after stopping the
>medication. But, surveys conducted by the Endometriosis Research Center
>(a patient advocacy group) with women who took Lupron® has indicated
>that over half of the respondents (51.67%) experienced side effects
>lasting for longer than six months; for almost one-quarter (23%) of the
>women, side effects lasted longer than five years4. Other clinical
>studies have found that almost three-quarters (72%) of women taking
>Lupron® experience memory difficulties, and that these memory
>problems can last as long as six months after the study was conducted5.
>
>The company seems to know that something's not right. In "a
>report submitted by TAP Pharmaceuticals to the FDA in April 1998,
>researchers wrote that they were `concerned' because more than
>one-third of the women they studied who took Lupron® did not
>`demonstrate either partial reversibility' or `a trend
>toward return' of bone mass in the six months after they stopped
>taking the drug. Further, the researchers noted some women lost as much
>as 7.3 percent of their bone density during treatment — more than
>twice the amount the drug's packaging lists in its warnings. The
>researchers concluded, `A more complete assessment of the effects of
>Lupron on [bone density] can only be made with longer term follow-up of
>these patients.'"2 But the company never invested in that follow-up
>research, and the FDA hasn't yet required it to.
>
>Lupron® for Endometriosis and Fibroids
>
>The FDA approved Lupron® to treat both endometriosis and anemia
>associated with uterine fibroids. Endometriosis is a painful, chronic
>disease that affects over five million women and girls in the U.S.6 It
>occurs when tissue lining the uterus is found outside the uterus,
>usually in the abdominal-pelvic cavity. This misplaced tissue develops
>into growths or lesions that respond to the menstrual cycle like the
>uterine lining: each month the tissue builds up, breaks down, and sheds.
>Unlike menstrual blood, however, the blood and tissue shed from
>endometrial growths have no way to leave the body. The result is
>internal bleeding and inflammation that can cause pain, infertility,
>scar tissue formation, adhesions, and bowel problems.
>
>Uterine fibroids are benign growths on the uterus' muscular wall
>that can cause pelvic pain, heavy bleeding, clotting, and pain during
>sex. Around three-quarters (77%) of all women of reproductive age in the
>U.S. will develop fibroids, and 25 percent will experience negative
>symptoms as a result.7 African-American women are about three times more
>likely to develop fibroids than women of other racial groups.7
>
>The exact cause of these conditions is not yet known (although there may
>be a link with estrogen production or exposure to the environmental
>toxin dioxin) and no non-invasive tests exist to provide a definitive
>diagnosis. Treatment for fibroids has traditionally involved a complete
>hysterectomy, which is not an option for women who want to get pregnant
>later. For endometriosis, laparoscopic or abdominal surgery to remove
>endometrial lesions can produce relief, but may fail if the surgeon is
>unskilled or the disease is particularly severe. For these reasons, many
>doctors encourage women with these conditions to use drug therapy to
>adjust estrogen levels in an effort to shrink fibroids or lesions.
>Despite the fact that no drug has been proven to provide lasting relief
>for either condition, Lupron® has emerged as the most-frequently
>prescribed medication for women with fibroids and endometriosis.
>
>Lupron® for Infertility Treatment
>
>Lupron® is also widely used as part of Assisted Reproductive
>Technology (ART) -- fertility treatments such as in vitro fertilization
>(IVF) in which both eggs and sperm are handled. The Centers for Disease
>Control and Prevention (CDC) notes that more than one percent of all
>U.S. births result from assisted reproductive technologies.8 (ART does
>not include treatments in which only sperm is handled, like artificial
>insemination, or when the woman takes drugs only to stimulate eggs but
>they are not retrieved.)
>
>Assisted reproductive technology efforts use GnRHs as part of the
>process of harvesting donor and non-donor eggs. The hormones are
>injected into the woman's body to shut down the ovaries; then other
>drugs are used to stimulate egg production and facilitate multiple egg
>extraction. (The eggs are fertilized in a lab and then implanted into
>the woman.) Lupron® is among the most common GnRH analogs used as
>part of this process. IVF patients report that they are told that the
>use of GnRHs is an essential step; some have been required to take
>Lupron® to continue their IVF treatment, despite any objections they
>may have had.
>
>There have been no prospective or clinical studies on Lupron®'s
>safety for ART patients and the FDA has not approved Lupron® for use
>in infertility treatment or assisted reproduction procedures such as
>IVF. Its use occurs "off label", an option that allows an
>FDA-approved drug to be used for medical purposes neither originally
>specified in the drug's approval nor described on the drug's
>labeling.
>
>"I have been to a total of 17 doctors since taking Lupron with many
>different diagnoses and there doesn't seem to be an end in sight. I
>don't know why we can't seem to get someone in the medical field
>to look into the on-going side effects of this drug. There is something
>definitely wrong with a drug when you go from being perfectly healthy to
>having all kinds of medical problems and you know that in your heart it
>started while on Lupron. I do know that I am not alone. I used to think
>I was but I have personally spoken to people that have taking Lupron and
>they are experiencing the same problems.'"
>
>Significant Safety Concerns
>
>Lupron® is an "antineoplastic agent", meaning that it is a
>cancer chemotherapy drug. Like all antineoplastics, Lupron® is
>harmful to both cancerous and non-cancerous cells — particularly to
>pregnant women and developing fetuses. In addition to the harmful
>side-effects reported by women using Lupron® for its approved uses,
>there are concerns about its effects when used as part of assisted
>reproductive technologies, such as IVF.
>
>The National Institutes of Health (NIH) and the Occupational Safety and
>Health Administration (OSHA) categorize Lupron® as a "hazardous
>drug" that health care workers should only handle when wearing
>protective gowns and gloves.9 They also recommend that health care
>professionals who intend to conceive or father a child avoid handling
>Lupron® or other such hazardous drug for three months before
>conception.10
>
>Abbott's patient education materials note that the FDA advises women
>who are, or may become, pregnant not to take Lupron® because of the
>risks to the developing fetus.11 The drug information describes
>"major fetal abnormalities" seen in pregnant rabbits after
>Lupron® was injected at doses 1/1200--1/12 the human pediatric
>dose.12 The company states that women who are pregnant should not use
>Lupron®, recommends the use non-hormonal contraception to prevent
>pregnancy while on Lupron®, and encourages those who think they might
>be pregnant to contact their health care providers immediately.13 The
>popular website, Drugs.com <http://www.drugs.com/> , states flatly:
>"Lupron causes birth defects."14
>
>Yet, despite these risks, and the fact that women may experience side
>effects months after discontinuing the drug, Lupron® is prescribed
>not only for approved uses to treat endometriosis and fibroid, but also
>for off-label use in assisted reproductive technologies.
>
>"My exposure to Lupron began in 1989, and shortly thereafter I began
>having multiple health problems, and have subsequently amassed a room
>full of documents, correspondences and medical literature devoted to the
>risks of Lupron. Since testifying in March 2003 on these risks in
>Congress (where I nearly puked on the Senate floor), I've been
>hospitalized 33 times, and am now disabled and had to retire from my
>career as a psychiatric RN. It's been very difficult, especially
>these last five years, but at least I've finally been able to start
>my website: www.LupronVictimsHub.com <http://www.lupronvictimshub.com/>
>."
>
>If the drug is doing what it should and helping women suffering from
>fibroids, endometriosis, or infertility, that's one thing. But what
>if the drug doesn't work or was approved based on faulty data?
>According to at least one activist, the clinical studies filed with the
>FDA on Lupron®'s effectiveness at reducing endometriosis-related
>pain were based on small numbers of women who were also allowed to take
>other pain-killers (including narcotics) at the same time.15 The
>Endometriosis Research Center's survey found that almost half of the
>responding women (48.19%) reported Lupron® to be
>"intolerable" and "not helpful" for relief of their
>endometriosis symptoms.4
>
>Even more startling, the Federal Dept. of Health and Human Services'
>Office of Research Integrity determined that the lead investigator
>involved with studies on Lupron®'s use in treating fibroids and
>endometriosis committed scientific misconduct, and admitted to
>falsifying or fabricating 80 percent of the data in two published
>studies on Lupron®. 16 The Federal Register noted that the
>investigator "altered and fabricated information in permanent
>patient medical records and notes by changing dates, changing and adding
>text, and fabricating notes for clinic visits that did not occur."16
>Those studies were retracted.
>
>"It is devastating to agree to an FDA-approved drug, under the care of a
>physician you trust, only to find yourself sicker than you could
>possibly imagine, in pain, and unable to get treatment or even be
>believed."
>
>Avoiding Long-Term Harm: The Informed Rx Decision-Making Consortium
>
>Lupron® is a hazardous drug with side-effects that can last for weeks
>or months after the drug is discontinued, but do the women taking it
>know that? It's not clear how much patients are being informed about
>Lupron®'s risks – certainly some people might decide that the
>drug's harmful effects outweigh the potential benefits. In addition,
>the fact that the drug has not been approved or assessed for use in ART
>procedures such as IVF may be of particular concern to both patients and
>egg donors.
>
>One researcher has commented: "GnRH analogs [like Lupron] are not
>like any other medication currently available for treatment of disease.
>As we continue to learn more about these analogs' mechanisms of
>action, it is increasingly apparent that they do not just affect the
>gonadal [sex] hormones, but are powerful modulators of autonomic neural
>function."17 Shouldn't we know more about these drugs -- and
>Lupron® in particular?
>
>It is an enormous problem that no data are being gathered on
>Lupron®'s long-term effects on women using the drug for
>endometriosis, fibroids, or ART. We believe that women must receive
>complete information about Lupron®'s efficacy and effects in
>order to truly informed decision about whether or not to take the drug.
>To determine Lupron®'s short- and long-term effects, and create
>conditions under which patients can provide true informed consent, the
>NWHN believes that several measures are needed.
>
>The FDA has recently received funding for additional oversight
>activities and NWHN believes that the agency should review the safety
>and efficacy of Lupron® for both its approved and off-label uses. As
>part of this process, the FDA must require Abbott Pharmaceuticals to
>conduct the assessment of Lupron®'s long-term effects on bone
>density that the company itself has said were needed. To gather
>up-to-date information on adverse events, a registry should be
>established to monitor the drug's effect on women, as well as on any
>children exposed to Lupron® either before conception or as part of
>their mother's IVF. Women who have experienced adverse events are
>encouraged to report them to the FDA by contacting MedWatch
><http://www.fda.gov/medwatch/report/consumer/consumer.htm> .
>
>"In order to halt this drug from causing damage to even one more woman's
>health, a concerted effort of women, physicians, health officials,
>researchers and media is needed. The decision to raise public awareness
>so that other women could be spared the physical, emotional and
>financial burdens Lupron causes would truly be in the interest of
>women's health around the country. The people who are considering
>taking Lupron are the ones who have the right to know that they are
>risking a lifetime of symptoms that may cost them their jobs, spouses,
>savings and quality of life."
>
>In addition, the NWHN has initiated a public education and policy
>campaign to get the word out about the misuse and dangers of Lupron®
>and other drugs. Along with the Center for Medical Consumers, the
>Endometriosis Association, and Our Bodies Ourselves, we have formed The
>Informed Rx Decision-Making Consortium. The Consortium will work to
>educate women about inappropriate drug use and provide tools to help
>them make better-informed decisions about prescription drugs --
>including how to determine what works, what doesn't, and what
>cost-effective alternatives exist. For more information about the
>Consortium and the campaign, visit the NWHN's website
><http://www.nwhn.org/> in the coming months.
>
>Susan K. Flinn is the Editor of the WHA; Lynne Millican provided
>significant assistance with this article.
>
>REFERENCES
>
>1. Norsigian J, "Concerns about Lupron™ (leuprolide acetate),
>used in the process of extracting eggs from women (for IVF, research
>cloning, and potentially for inheritable human modifications), OBOS
>Health Resource Center, October 2002, accessed 9/5/08 from
>
>http://www.ourbodiesourselves.org/book/companion.asp?id=25&compID=67&pag\
>e=5
>
>2. Norsigian J, "Egg Donation for IVF and Stem Cell Research: Time
>to Weigh the Risks to Women's Health," OBOS Health Resource
>Center, 2005, accessed 9/5/08 from
>
>http://www.ourbodiesourselves.org/book/companion.asp?id=31&compID=97&pag\
>e=3
>
>3. In 2008, Abbott Pharmaceuticals and Takeda Pharmaceutical Company
>concluded this joint venture; Abbott Pharmaceuticals now manufacturers
>Lupron (other pharmaceutical companies also manufacture GnRHa drugs).
>
>4. Endometriosis Research Center (ERC), "Use of GnRH Agonists Prior
>to an Endometriosis Diagnosis," Delray, FL: ERC, 2003, p. 2.
>
>5. Varney NR, Syrop C, Kubu CS et al, "Neuropsychologic Dysfunction
>in Women Following Leuprolide Acetate Induction of Hypoestrogenism",
>Journal of Assisted Reproduction and Genetics 1993; 10(1):53; Newton C,
>Slota D, Yuzpe AA et al, "Memory complaints associated with the use
>of gonadotropin-releasing hormone agonists: a preliminary study",
>Fertility and Sterility 1996; 65(6):1253. Norsigian J, "Egg Donation
>for IVF and Stem Cell Research: Time to Weigh the Risks to Women's
>Health," OBOS Health Resource Center, 2005, accessed 9/5/08 from
>http://www.ourbodiesourselves.org/
>book/companion.asp?id1&compID—&page=3. Citing Lazar, Kay,
>"Wonder drug for men alleged to cause harm in women," Boston
>Herald, August 22, 23, 24, 1999.
>
>6. US. Dept of Health and Human Services (HHS). "Women's
>Healthcare Forum -- Endometriosis," Rockville, MD: HHS, August 2008.
>Accessed 9/8/08 from
>http://www.womenshealthcareforum.com/endometriosis.cfm.
>
>7. National Institute of Child Health and Human Development (NICHD),
>"Fact Sheet -- Uterine Fibroids", Rockville, MD: NICHD, December
>22, 2005. Accessed 9/8/08 from
>http://www.nichd.nih.gov/publications/pubs/upload/uterine_fibroids_2005.pdf.
>
>8. CDC, "2005 Assisted Reproductive Technology Success Rates:
>National Summary and Fertility Clinic Report", MMWR
>2008;57(SS-5):1–23. On-line: http://www.cdc.gov/ART/ART2005 visited
>9/16/08.
>
>9. Listed as leuprolide acetate. National Institutes for Occupational
>Safety and Health (NIOSH), NIOSH Alert: Preventing Occupational
>Exposures to Antineoplastic and Other Hazardous Drugs in the Healthcare
>Setting. Cincinnati, OH: Centers for Disease Control and
>Prevention/NIOSH, Sept. 2004, p. 12, 37.
>
>10. American Society of Health-System Pharmacists, American Hospital
>Formulary System Revised Guidelines 1999, Bethesda MD: ASHSP, pp.
>1030-1.
>
>11. Patient Information on Treatment with Lupron Depot 3.75 mg
>[Endometriosis and Uterine Fibroids], and Patient Information on
>Treatment with Lupron Depot 11.25 mg [Endometriosis and Uterine
>Fibroids], Lake Forest, IL: TAP Pharmaceuticals, 2001-2004, p. 3
>
>12. Lupron Depot 3.75 mg Package Insert, Lake Forest, IL: TAP
>Pharmaceuticals, Oct. 2005, p. 8.
>
>13. Lupron Depot 3.75 mg Package Insert, Lake Forest, IL: TAP
>Pharmaceuticals, Oct. 2005, p. 6; Patient Information on Treatment with
>Lupron Depot 3.75 mg [Endometriosis and Uterine Fibroids]; and Patient
>Information on Treatment with Lupron Depot 11.25 mg [Endometriosis and
>Uterine Fibroids], Lake Forest, IL: TAP Pharmaceuticals, 2001-2004, p.
>5.
>
>14. http://www.drugs.com/lupron.html (visited 9/5/08) "Findings of
>Scientific Misconduct",
>
>15. Endometriosis Research Center, "Use of GnRH Agonists Prior to an
>Endometriosis Diagnosis," Delray, FL: Endometriosis Research Center,
>2003, p. 2.
>
>16. Federal Register 1996; 61(85):19295-6. Online through:
>http://www.gpoaccess.gov/fr/retrieve.html. Accessed 9/17/08.
>
>17. Mathias JR, Clench MH, "Placebo Controlled Study Randomizing
>Leuprolide Acetate", Digestive Diseases and Sciences 1995;
>40(6):1405.
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