Colposcopic findings and intraepithelial neoplasia in diethylstilbestrol-exposed offspring

The Dutch experience, 1989

Colposcopy-Procedure image
Colposcopy in DES-exposed offspring in inexperienced hands can result in many unnecessary biopsies. Therefore colposcopic examination should be performed by expert colposcopists in referral diethylstilbestrol centers.
Colposcopy procedure image via colposcopyinfo.

1990 Study Abstract

Data from two regional diethylstilbestrol clinics for colposcopic evaluation of young women with a history of diethylstilbestrol exposure in utero are presented:

A total of 224 subjects with a well-documented history were enrolled in this study.

  • Structural anomalies of the cervix and vagina were found in 30%.
  • Vaginal epithelial changes were colposcopically observed in 65%,
  • including vaginal adenosis in 22%.
  • The prevalence rate of abnormal cytologic findings in the study group was 9%.
  • In half of these patients a low-grade intraepithelial neoplasia of the cervix and vagina was found.

It was concluded that colposcopy in diethylstilbestrol-exposed offspring in inexperienced hands can result in many unnecessary biopsies. Therefore colposcopic examination should be performed by expert colposcopists in referral diethylstilbestrol centers.

Sources and more information
  • Colposcopic findings and intraepithelial neoplasia in diethylstilbestrol-exposed offspring. The Dutch experience, NCBI PubMed PMID: 2589438, Am J Obstet Gynecol. 1989 Nov;161(5):1191-4.
More DES DiEthylStilbestrol Resources

The Hypoactive Sexual Desire Disorder and the Female Sexual Function Index…

Drug industry links run deep in field of sexual medicine

woman-and-frog image.
The FSFI is a brief questionnaire measure of sexual functioning in women…
The Journey, woman and frog image by Thomas Hawk.

Hypoactive Sexual Desire Disorder (HSDD)

Alan Cassels, a drug policy researcher at the University of Victoria said:

“The main hurdle (for – Addyi – approval) was to try and define the disease,”…
“And I think (Sprout) bamboozled the FDA into considering this a disease.”…
“This (HSDD-targeting) drug will be marketed to everyone who doesn’t want to have sex, for whatever reason – the ‘Not tonight, honey, I have a headache’ market.“…
“The market has been shaped around turning lack of desire into a disease and I think it’s highly problematic,” …  “This idea that you can tamper with and increase sexual desire with a pill – this is the brave new world.”…

Dr. Adriane Fugh-Berman , Director of PharmedOut, Georgetown University Medical Center said:

“Creating a diagnosis gives a company monopoly over the market it created,” …

Female Sexual Function Index (FSFI)

Ray Rosen, the psychiatrist who led the FSFI panel said:

“Obviously, there’s no biochemical thing you can measure to say ‘this women has so much desire,’ so it has to be a subjective rating of some kind,”…

Dr. Adriane Fugh-Berman , Director of PharmedOut, Georgetown University Medical Center said:

“The industry-generated tests are rigged tests, designed to make healthy people think they are ill,”… “They medicalize normal human variation and normal ups and downs.”…

Sources and more information
  • FSFI © Questionnaire PDF File.
  • FSFI Scoring Appendix PDF File.
  • The Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function, Journal of Marital and Sex Therapy: 2000: 26:191-208.
  • Drug industry links run deep in field of sexual medicine,
    medicalxpress, August 20, 2015.
  • Female Viagra’ okayed in U.S., may come to Canada, thestar, Aug 19 2015.

Pesticides et épandages aériens en France

Interdisons (vraiment) les épandages aériens de pesticides !

epandage-aerien-pesticides
Juin 2015, justice, pulvérisations aériennes de pesticides et châtaignes : Générations Futures et des particuliers déposent plainte. Interdisons (vraiment) les épandages aériens de pesticides!

Ce n’est pas le moindre des paradoxes que de soumettre à consultation un arrêté dont le but premier est de légaliser les épandages aériens en laissant supposer que l’arrêté en question viserait à accélérer la fin des dits épandages….

En savoir plus

Pesticides et excès de cas de cancers pédiatriques dans le Sauternais

Preignac : les pesticides viticoles ont-ils causé des cancers pédiatriques?

ecole-preignac
Cancers pédiatriques : la responsabilité des pesticides n’étant pas écartée, la municipalité de Preignac a décidé d’acheter les vignes autour de l’école afin de limiter les risques potentiels.

Le 19 décembre 2012, le maire de Preignac Jean-Pierre Manceau a écrit à l’Institut national de veille sanitaire, INVS. Dans ce courrier, le maire fait état de cas de cancers déclarés chez des enfants fréquentant ou ayant fréquenté l’école primaire de la commune, laquelle est contigüe à des parcelles viticoles traitées aux pesticides.
Jean-Pierre Manceau demande donc à l’INVS de mener une investigation, afin de déterminer s’il y a bien davantage de cancers pédiatriques à Preignac, et si cela peut-être lié à l’usage des pesticides.

L’INVS a donc réalisé cette investigation, dont les conclusions ont été publiées le 5 août 2015.

  • Trop de cancers pédiatriques par rapport à la moyenne
  • La responsabilité des pesticides pas écartée

 

Ecoutez l’interview de Marie-Lys Bibeyran durant le reportage de France3 Régions, 10/08/2015.

En savoir plus
  • Investigation d’une suspicion d’agrégat de cancers pédiatriques dans une commune viticole de Gironde, InVS, le 05/08/2015. Rapport PDF.
  • Preignac : les pesticides viticoles ont-ils causé des cancers pédiatriques?, infomedocpesticides, 10 août 2015.

Addyi Flibanserin HSDD Drug is FDA-approved!

HSDD treatment by Sprout Pharmaceuticals

Sprout-pharma--Women image
Meet addyithe first of her kind – and The Sprout Pharmaceuticals women.

This post content is published by the U.S. Food and Drug AdministrationProtecting and Promoting Your Health.

FDA approves first treatment for sexual desire disorder

The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.

The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials, of whom about 1,700 received treatment for at least six months and 850 received treatment for at least one year.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.

The FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public Patient-Focused Drug Development meeting and scientific workshop on female sexual dysfunction on October 27 and October 28, 2014, to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Addyi to the FDA’s MedWatch Adverse Event Reporting program at http://www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ”

More information

  • Full Prescribing Information, addyi, Revised: 8/2015.
  • Medication Guide, addyi, 8/2015.
  • As FDA approves ‘pink Viagra’ for women, controversy persists,
    latimes, AUG 19, 2015.
  • FDA approves ‘female Viagra’ pill Flibanserin after two rejections,
    theguardian, AUG 18, 2015.
  • FDA Approves Addyi (Flibanserin), ‘A Milestone Moment’ In Women’s Health,
    Forbes, AUG 18, 2015.

A Guide to Prescription Drugs in the United States

Many people in the US regularly use prescription drugs

Guide to Prescription Drugs in the U.S.
Many people in the United States regularly use prescription drugs.

Becoming more familiar with prescription drug development can help many Americans make decisions that are more informed in regards to their medications:

  • Discovery and Subsequent Development
  • Preclinical Research
  • Clinical Research
  • FDA Review
  • Post Market Safety Monitoring
  • Online Tools and Further Research
Sources and more information

Could antibodies in eggs protect livestock from infection without antibiotics?

Researchers test alternative to livestock antibiotics : eggs

antibodies-in-eggs mage
Animal scientists have stumbled upon a possible way to protect livestock from infection without antibiotics — by feeding them eggs. The eggs contain antibodies, which help keep an animal’s immune system active to fight off disease. Image by Journal Sentinel via UW-Madison.

The chickens weren’t getting sick like they were supposed to.
So the scientists gave them 10 times the normal dose of parasites — enough to produce a severe illness. Still nothing. In fact, the birds looked like they were never infected.
Researchers were trying to hijack the chickens’ immune system to study runaway inflammation.
But the experiment failed. Instead, they stumbled upon a possible way to protect livestock from infection without antibiotics — by feeding them eggs. The eggs contain antibodies, which help keep an animal’s immune system active to fight off disease. ”

… continue reading Researchers test alternative to livestock antibiotics — eggs, Journal Sentinel, Inc., Aug. 17, 2015.

Original publication: UW-Madison startup offers antibiotic alternative to animal producers, UW–Madison News, 6.1.15.

Flibanserin explained on Video

What Big Pharma Doesn’t Want You To Know About “Female Viagra”

An investigation by ThinkProgress reveals that the Flibanserin drug‘s public relations campaign is highly misleading and its effectiveness is modest at best… video published on 14 August 2015.

More information
  • What Big Pharma Doesn’t Want You To Know About ‘Female Viagra’, thinkprogress, 14 August 2015.
  • Watch more pharma videos on @DES_Journal YT channel.

Half-polluted or Half-protected?

Gas Wells Are Not Our Friends

half-polluted
Check-out @DES_Journal health cartoons album on Flickr.

DEC’s hydrofracking cocktail… cartoon credit: Marquil, empirewire.com

Sources and more information

The Parents who sued Doctors over their Toddler’s Sexual Assignment Surgery

Parents Sue Doctors For Deciding Their Kid Is A Girl

We just hate that there were choices made that could have a significant impact on his being able to be a man” said the parents who accuse hospital of negligence and medical malpractice for not getting the patient’s informed consent before surgery.

In 2013, in a first of its kind lawsuit, Greenville, S.C., residents Pam and Mark Crawford decided to sue the doctors who gave their adopted son sex assignment surgery while in foster care. MC, who had been deemed a female by doctors, had surgery at 16 months to “correct” his status as intersex (having both male and female genitalia), but is struggling with this assigned identity now at 10 years old. His parents are grieving that such a decision was made for him before he was able to make it himself.

Sources and more information