Suspension of FDA Approval urged for new Morning Sickness Drug Diclegis

Another preventable future health tragedy?

#Diclegis is #FDA approved to replace #Bendectin as new Morning Sickness DrugJill Escher, from Prenatal Exposures Never Die, the blog about epigenetics, autism, and the multigenerational tragedy of prenatal pharmaceutical use, wrote to the FDA on April 11. 2013.

I am writing to urgently request that the FDA take immediate steps to suspend approval for the prenatal drug Diclegis pending appropriate safety testing for impacts to fetal germ cells, the precursor cells to the baby’s egg or sperm. In addition, I urge the FDA to take immediate steps to issue warnings regarding potential germline impact of all prenatally administered drugs… ”

Read Suspension of Approval Urged for New Morning Sickness Drug, Diclegis, Pending Assessment of Fetal Germline Impacts, April 11. 2013.

Related post: Diclegis FDA approved to replace Bendectin as new Morning Sickness Drug: future Health Tragedy?.

Diclegis FDA approved to replace Bendectin as new Morning Sickness Drug

Another preventable future health tragedy?

#Diclegis is #FDA approved to replace #Bendectin as new Morning Sickness DrugA new pregnancy drug, the Diclegis® pill manufactured by  Duchesnay Inc. Canada, will enter pharmacies this June 2013.  This week (see tweet), in its news release, the FDA stated: ” The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting “.

The “Morning Sickness Drug“, was called Bendectin between 1978 and 1983, and had over 300 lawsuits filed against the Merrell Dow pharmaceutical company, claiming damages for babies with deformities born to mothers who took the drug. The wide range of birth defects attributed to it were: limb and other musculoskeletal deformities; facial and brain damage; defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems; blood disorders and cancer.

With many thanks to Judith Kavanaugh for warning me about this unbelievable but true news !!!

More information

The Push to Prescribe

Women and Canadian Drug Policy, by Anne Rochon Ford and Diane Saibil

The Push to prescribe: Women and Canadian Drug Policy, by Anne Rochon Ford and Diane Saibil on Flickr
The Push to prescribe: Women and Canadian Drug Policy, by Anne Rochon Ford and Diane Saibil.

In recent years, heated debate has surrounded the pharmaceutical industry and how it has gained unprecedented control over the evaluation, regulation, and promotion of its own products. As a result, drugs are produced, regulated, marketed, and used in ways that infiltrate many aspects of everyday life. The nature and extent of this infiltration, and how this has special meaning for women, are at the core of The Push to Prescribe.

The book delves into the world of prescription drugs in Canada, and considers the impact on the health of women. From the inadequate testing of many drugs on women in clinical trials, to the sometimes questionable portrayal of women in illegal prescription drug advertising, Canadian drug policy has not always paid attention to how women and men are affected differently.

This is an essential resource for a variety of courses in Health Sciences, Medicine, Nursing, Pharmacology, Public Policy, Public Health, Health Policy, Women’s Studies, Women’s Health, as well as many Social Science courses in areas like Sociology and Political Science. It will also be of interest to a general audience, health professional organizations, government health associations, and consumer and women’s groups.

SPECIAL FEATURES

  • presents an approach that combines compelling evidence with social, political, and gender-based analyses
  • discusses the complexity surrounding women and pharmaceuticals and uses the best evidence to argue for changes that better reflect women’s needs in public health policy and that ensure those who are best suited to make these determinations are included in policy-making

RELATED LINKS

Anti-Depressants in Pregnancy: is there Evidence of Benefit?

Do antidepressant medications work the way they are supposed to?

Watch the webinar discussion  about women and Canadian drug policyAntidepressants are increasingly being used to treat depression in pregnancy in Canada despite their lack of approval for this use by Health Canada or the US FDA. Recent scientific and public attention has focused on an increased risk for infants, and this has led to conflicting advice about the use of SSRI/SNRI antidepressants (such as Prozac, Paxil, Effexor, or other related drugs) during pregnancy. Some suggest avoiding all exposures, while others recommend use in order to avoid harm to mothers and infants from untreated depression.

In 2009, Dr. Barbara Mintzes presented what she and colleagues found in a systematic evaluation of all available studies comparing women with depression who did or did not take antidepressants during pregnancy. Their goal was to find an answer to the controversial and urgent clinical question: do pregnant women benefit from taking antidepressants?

Watch the webinar discussion  about women and Canadian drug policy.

You watched the webinar? Please share your thoughts!

Why Researchers MUST publish ALL Results of Clinical Trials

Make all medical research results public

Make all research results publicA new campaign All trials registered, all results reported  – supported by the Medical Research Council  (publicly funded organisation in the UK dedicated to improving human health) – calls for the results of all clinical trials to be made public.
Sir Iain Chalmers, Coordinator of the James Lind Initiative, has strong words on researchers who hide trial results and ends his post by saying: “ If action is not taken urgently by research funders and regulators, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, unnecessary repetition of trials, and missed opportunities for good medical practice. ”

Read Make all research results public, insight, 4 April 2013.
#AllTrials website and donation site.

Watch the Seattle Book Discussion about Bad Pharma

How Drug Companies Mislead Doctors and Harm Patients

Watch the Seattle Book Discussion about Bad Pharma, an 86 min Video with @BenGoldacreLast February 18th, 2013, at Town Hall Seattle, Dr. Ben Goldacre talked about his book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, in which he discusses the influence of the pharmaceutical industry on the global healthcare system and argues that pharmaceutical companies hide negative studies and use questionable testing and intensive lobbying to get what they want, regardless of whether the drugs they produce are good for patients. Watch the video  (1 hour, 26 minutes) .

More about Ben Goldacre

DES Videos in English – Diethylstilboestrol YT video channel.

Prenatal Dexamethasone for Congenital Adrenal Hyperplasia

Fetal Engineering Very Dangerous Experiment

Fetal Engineering dangerous Experiment: Prenatal Dexamethasone for Congenital Adrenal HyperplasiaScience Daily post Dangerous Experiment in Fetal Engineering analyses Prenatal Dexamethasone for Congenital Adrenal Hyperplasia published in the Journal of Bioethical Inquiry using extensive Freedom of Information Act findings to detail an extremely troubling off-label medical intervention employed in the U.S. on pregnant women to intentionally engineer the development of their fetuses for sex normalization purposes.

2012 Study Abstract

Following extensive examination of published and unpublished materials, we provide a history of the use of dexamethasone in pregnant women at risk of carrying a female fetus affected by congenital adrenal hyperplasia (CAH). This intervention has been aimed at preventing development of ambiguous genitalia, the urogenital sinus, tomboyism, and lesbianism. We map out ethical problems in this history, including: misleading promotion to physicians and CAH-affected families; de facto experimentation without the necessary protections of approved research; troubling parallels to the history of prenatal use of diethylstilbestrol (DES); and the use of medicine and public monies to attempt prevention of benign behavioral sex variations. Critical attention is directed at recent investigations by the U.S. Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP); we argue that the weak and unsupported conclusions of these investigations indicate major gaps in the systems meant to protect subjects of high-risk medical research.

This is insane ! This shows NOTHING has been learned from the thalidomide and DES experiences.

Notice de Distilbène® DES, prescrit en France jusqu’à 1977…

…”utilement employé dans: menaces d’avortement”. ! ? ! ?

Notice de Distilbène® DES, prescrit en France jusqu'à 1977

Le Distilbène DES, en savoir plus

Big Pharma and Doctors, or the Influence of the Pharmaceutical Industry

Why do so many doctors still think they are invincible to Big Pharma’s influence?

Doctors Are Under the Influence of Pharma DrugsThe bottom line for any for-profit company is to sell their product, and since the pharmaceutical industry can’t sell drugs directly to patients, they convince doctors to prescribe them.
The more a doctor sees or hears the name of a drug, whether through drug reps, brochures or seeing the name on stationery, the more likely the drug is to be prescribed
. ”

Read Doctors Are Under the Influence of Pharma Drugs by Ritika Goel, 04/02/2013.

Pay-to-delay Deals keep Consumer Prices artificially high to protect Drug Patent-Holders’ Profits

Pay-to-delay deals costly for the general public

How ‘Pay for Delay’ Keeps Us Paying More for Prescription Drugs” … When a company’s patent on a brand-name drug expires, other companies are free to make generic versions of the same drug… Often times, there are legal disputes between brand-name drug manufacturers and generic-drug companies. It’s increasingly common for this litigation to end with out-of-court settlements in which patentholders pay potential competitors to delay the introduction of generics.
That’s pay-to-delay
… ”

Read PD Editorial: Pay-to-delay deals costly for consumers.

Read How ‘Pay for Delay’ Keeps Us Paying More for Prescription Drugs.