Click here to read this mailing online.

Your email updates, powered by FeedBlitz

 
Here is a sample subscription for you. Click here to start your FREE subscription


"FIDDAMAN BLOG" - 5 new articles

  1. Birth Defect Ethics, Are They as Simple as Black & White?
  2. Prozac: Uncharted Down Syndrome Territory
  3. Pharmaceutical Rape - Do We Need Video Evidence?
  4. The Mental Health "Stigma"
  5. Two Former Glaxo Scientists Charged With Trying to Steal Data
  6. More Recent Articles
  7. Search FIDDAMAN BLOG
  8. Prior Mailing Archive

Birth Defect Ethics, Are They as Simple as Black & White?






Quite often questions come to me, usually at night whilst in bed alone, save for the background music of Hans Zimmer that helps me drift off to sleep.

One such question, invoked another, they both kept me awake for most of the night as I mulled over possible answers, the most obvious answer, of course, would be jail time.

Here's what I was mulling over.

SCENARIO:

A husband and wife have a disagreement over treatment. Mrs Smith has recently been told that she is pregnant, she has also been diagnosed with depression and has been told by her physician that if left untreated it could harm her fetus. Mrs Smith believes the risk of taking antidepressants during pregnancy is too high, she has read stories that they can cause birth defects.

Her husband, Mr Smith, does not believe the risks are that high, he's read many published papers from academics that suggest antidepressant treatment will save the baby from becoming distressed inside the womb and depressed when born.

So, here's the dilemma. It's his child just as much as it is his wife's. They are at loggerheads over the decision to medicate - does the expectant mother have the final say?

This isn't the question that kept me awake.

Mr Smith, decides to treat his wife with antidepressants (without her knowledge... ergo, without her consent)

Every day he crushes two antidepressants into her dinner - he does so because he wants to protect his child from being distressed in the womb or being born depressed. Hey, he's read the literature and believes it to be true.

24 weeks later

Sadly, Mr and Mrs Smith are informed that the fetus has developed defects. Mrs Smith's OBGYN has informed them both that the fetus has developed a number of birth defects, namely; cardiac defects (heart), pulmonary defects (lung), neural-tube defects (brain and spinal cord). Chances of survival, at birth, he informs them, are very slim.

Mrs Smith, along with her husband, decide to abort the fetus, it's a heart-wrenching decision.

Aftermath

Shorty after the termination of his wife's pregnancy, Mr Smith comes clean and tells his wife that he had secretly been administering antidepressants into her food and now believes that the medication may have contributed to the birth defects in their child.

So, here's the two questions...

1. What legal action, if any, could Mrs Smith take against her husband?

2. What defence, if any, could Mr Smith use in a court of Law?

Be interesting to hear/read your comments on this one either via the comments section (below) or via my Twitter account (here) or Facebook Blog account (here)


Bob Fiddaman.


Related:

Prozac: Uncharted Down Syndrome Territory













    

Prozac: Uncharted Down Syndrome Territory








The University of Texas Southwestern Medical Center have announced new research and planning to see if Prozac (fluoxetine) can improve brain development, intellectual functioning, and behavior of children with Down Syndrome (DS) when given prenatally and postnatally during the first 2 years of life.

According to a breakdown of the study, found here, pregnant women and their unborn child will be assigned randomly to receive either fluoxetine or placebo in the study. Participants will have a 2 in 3 chance of receiving fluoxetine or placebo.


The study suggests...

During the prenatal study period, participants will take their assigned medication orally. After her child is born, the mother will stop taking the oral tablet of her assigned medication and her child will start a liquid solution of the medication to be taken orally. After birth, the fluoxetine dose will be adjusted as needed.

This, as far as I am aware, is a first as the ingestion of antidepressants by pregnant mothers has never been studied in a clinical trial before because, to date, it has always been deemed unethical. It throws up debate, much of it centered around antidepressants and the birth defect link, although this study's aim is not to prove whether or not antidepressant use in pregnancy can harm the fetus.

Very little has been mentioned in the press about this study save for a spattering here and there citing a study in mice whereby it was shown that mice with the extra copy of Down syndrome genes (like humans with DS), apparently improved the disturbed processes of brain development/function when treated with Prozac.

It's a tricky area as the target subject in this new study are both pregnant mothers and fetuses that have already been deemed to be carrying DS genes. Any help DS children can get in life should be applauded but is it right to put them at risk?

Half of the funds for the study have been raised by father, Paul Watson, who heard about the success of the studies in mice. Paul's son was born with Down syndrome.

Here's NBC reporting on the study... (If video does not load then it can be viewed here)




For years Prozac has been cited as one of the more safer SSRis on the market, in the UK, for example, it can still be prescribed to minors legally, the only SSRi that, apparently, does not show evidence of inducing suicidal thoughts in children and teenagers taking it. Surprisingly, the American drug regulator, the FDA, feel that Prozac should, just like the other SSRis on the market, carry a black box warning listing the dangers of its use in children and adolescents. As with all SSRis Prozac has never been deemed safe to give to pregnant mothers, that decision is left to both treating physician and the mother.

This study bothers me somewhat. Who has made this decision whereby it is now deemed ethical to study an antidepressant in a living fetus, end of the day a fetus with the down syndrome gene has just as much right to life as a "normal, healthy" human fetus.

Why has this study been given the green light, moreover, isn't this merely a guinea pig trial using a drug that can potentially cause more harm to the fetus on someone (the fetus) who has no say in the matter?

The study's lead author, Dr. Carol Tamminga, said, "the medical community has been giving Prozac to children with Down syndrome for years, but the effects of giving it to children in utero haven’t been tested." She added, "and this will really be the first controlled trial where we will get to test does this really work or not."

Tamminga's biography page shows that she has served as a Member and Chair of the Psychopharmacological Drugs Advisory Committee of the FDA. However, there is no mention of the payments made to her by Prozac manufacturers, Eli Lilly.

Jan. to Dec. 2011 - $1,574 for Business travel and other value.

Jan. to Dec. 2013 - $466 for Business travel and other value.

Jan. to Dec. 2013 - $267 for  Business Meals.

Tamminga has also received research support from Sunovion and travel funds from Autiphony Therapeutics and has served as a consultant for Astellas, Kaye Scholer LLC for Pfizer, and Lundbeck.

According to Drugwatch it is estimated that thousands of people have filed Prozac lawsuits citing a variety of adverse events including mental, emotional and physical suffering. Early cases have claimed that Prozac has caused an increased risk of suicidal thoughts and violent behaviour. Drugwatch also claims that by the year 2000 Prozac manufacturer, Eli Lilly had reportedly paid out more than $50 million to settle more than 30 Prozac lawsuits related to murders or suicides.

Drugwatch also claims that Prozac has been linked with birth defects, including anencephaly, a fatal defect in the neural tube. Newborns also can experience septal defects, damaged hearts or cleft lip or palate.

Yet here we are in 2016 putting this powerful SSRi into the bodies of pregnant mothers who are carrying a fetus with DS genes. Furthermore, here we are in 2016 giving a newborn baby from the age of 0-2 years the liquid formulation of Prozac.

Background of the study can be read here. Results are expected to be available within 12 to 18 months.

I do hope all the participants are given all the information about Prozac, including the information about the $50 million paid out in Prozac lawsuits related to murders or suicides and also Prozac's link to birth defects.

I honestly don't know what to say anymore.

Bob Fiddaman.


Related

Prozac Took My Child (Guest Post)

Open Verdict Returned in Prozac Related Death














    

Pharmaceutical Rape - Do We Need Video Evidence?







A series of guest posts on David Healy's blog (links at the foot of this post) have coined a new phrase, "Pharmaceutical Rape."

The posts, eloquently written by Laurie Oakley, a first-time author (Crazy And It Was - Surviving the Corporate Pharmaceutical Corruption of Western Medicine) and, in her own words, a simplicity junkie who delights in the rhythms of the so-called ordinary, have caused quite a stir and are a series of extracts taken from Laurie's second book, 'Rape Is Not A Metaphor - A Framework For Understanding Everyday Pharmaceutical Harms', due for publication later this year.

When one reads the headline, 'Pharmaceutical Rape' one can take it as the writings of a conspiracy theorist who is merely out to grab headlines, to shock, or one can also see it, as I do, as the quintessential analogy of the harms pharmaceutical companies (and their wares) can cause those who are not fully informed of potential risks when taking prescription medications. (That means all of us).

In fact, it's not even an analogy as it stands very much alone in its own right, yet we find ourselves explaining or clarifying it. Nor should it be deemed a metaphor, to do so would distract the reader from the harsh reality of it all. It is exactly what it is, it exists yet it's taken mother of two, Laurie Oakley, to tap into our psyche to show us what is already in front of us, such is the stranglehold and culture of the pharmaceutical industry.


In her latest post, Pharmaceutical Rape: The Good Patient, Laurie defines pharmaceutical rape culture. Take a long hard look at this paragraph, it's pure poetry...

A pharmaceutical rape culture is a culture in which iatrogenic harms are pervasive and normalized due to societal attitudes about medicine and health care. It is a complex set of beliefs that tolerates the commercialization of healthcare and supports everyday harms in medical and mental health care settings. It is a society where harm is only acknowledged as rare, yet is accepted as necessary, and inevitable. In a pharmaceutical rape culture, doctors and patients unknowingly trust what are oftentimes pseudo-scientific facts put forth by drug makers about drug safety. Both doctors and patients end up disbelieving the reality of the adverse events they see, and instead believe alternate explanations for such events. A pharmaceutical rape culture condones widespread medical harms that are rooted in reckless practices within the industry-government-medical trade alliance because multiple societal systems are involved in producing, reproducing, and disseminating “information” about pharmaceutical products. This “information” sat-urates the public and reinforces that alliance.

Coining the term, 'Pharmaceutical Rape', Laurie writes...

Pharmaceutical rape stems from the collective decisions of powerful individuals within an industry-government-medical trade alliance. It is an offense that results in an invasive violation of bodily autonomy for the victim. A pharmaceutical product is introduced into one’s body that causes harm — something one did not consent to — something that one had a legal right to more information about so that a different choice could have been made. Most often, it involves trusting and having that trust violated.

Which leads me to a video that has recently gone viral on the internet. It's not for the faint-hearted. Before you click the play button imagine, if you will, that the officers featured in the video, are, to family and friends, law abiding citizens who never cross the line between right and wrong. On the face of things they are decent human beings who have sworn an allegiance to protect the public.

Take a good look at their version of events compared to the version that was captured on CCTV. Also, listen to the county sheriff at the end of the video.



 


It's pretty shocking huh?

The video above depicts what is wrong with power. Imagine if the only angle of this footage that ever became available was the angle filmed by officers on the day, the victim, in this case Derrick Price, would no longer be the victim and, more than likely, the officers would have been praised for keeping crime off the streets.

The video is, more or less, an insight into how the public can be vocal when they see an abuse of power. Sadly, in the world of the pharmaceutical industry, the public rarely get an insight into what really goes on behind closed doors - many cases of harms caused by pharmaceutical drugs are settled and evidences are sealed and locked away from the public. We have no leaked videos of pharmaceutical bosses preparing their reps to promote drugs for use in children...when those drugs have never been deemed safe in children, nor do we have video footage of reps bribing doctors with monetary payments or lavish "gifts". More importantly, for me at least, is that not one single CEO of any pharmaceutical company, to my knowledge, has lambasted and taken action against those managers or key opinion leaders who knowingly violated the bodily autonomy of the countless victims who have suffered at the hands of pharmaceutical drugs, many of whom have been children.

Let's not forget the bystanders, namely the medicine drug regulators who have, for years, sat back and watched this pharmaceutical rape and said nothing - an accessory to pharmaceutical rape, perhaps? Remember, this isn't just pharmaceutical rape, it's pharmaceutical rape of minors.

Is the video above anymore shocking than the points raised by Laurie Oakley?

Judge for yourself by reading the first three parts in a series of five.







Bob Fiddaman


Further Reading:

















    

The Mental Health "Stigma"











Two news items of interest were sent to me over the past few days, both, it would seem, are aligned with one another.

First off, let's take a look out the worn out phrase that lots of mental health specialists and even celebrities seem to trawl out every 5 minutes or so.

The mental health stigma

This from the Mental Health Commission in Australia, I plucked the first one that appeared in a Google search, all mental health foundations say pretty much the same.

Three out of four people with a mental illness report that they have experienced stigma. Stigma is a mark of disgrace that sets a person apart. When a person is labelled by their illness they are seen as part of a stereotyped group. Negative attitudes create prejudice which leads to negative actions and discrimination.

There's not a day goes by when we hear the calls of organizations or celebrities calling for an end to mental health stigma. Canadian writer and actress, Mary Walsh, is one such celebrity.

Walsh is a spokesperson for Bell Let's Talk, an organization that has, according to their website, "Committed over $100 million to support a wide range of mental health organizations, large and small, from coast to coast to coast."

Bell Media is Canada’s premier multimedia company with leading assets in television, radio, out-of-home advertising, and digital media. Bell Media owns 30 local television stations led by CTV, Canada’s number 1 television network.

Today, Today, Bell will donate 5¢ more to mental health initiatives for every:


  • Text message sent
  • Mobile & long distance call made
  • Tweet using #BellLetsTalk
  • Share of the Facebook image

That's a very generous offer given that the figure could run into the millions of dollars.

I'm in agreement with them to a certain extent. Yes, we should talk about mental health but the subject matter shouldn't be what more can they do to help depressed people, it should be what harm are they doing to depressed people.

BellLetsTalk, however, seem to back up their stigma claims with some "facts", of which there are many. Here's a few...


In Canada, only 1 out of 5 children who need mental health services receives them. - CMHA

Mood and anxiety disorders impact an estimated 22% of the Canadian population. - CMHA

Suicide accounts for 24% of all deaths among 15-24 year-olds and 16% among 25-44 year-olds. - CMHA

CMHA stands for the Canadian Mental Health Association, their homepage shows one of their principle sponsors to be Lundbeck, manufacturers and marketers of such drugs as Celexa (citalopram) and Lexapro (escitalopram) - which leads me nicely to the second news item that was sent to me this week.

Yesterday the New York Times (NYT) ran a feature regarding an apparent influential government-appointed health panel who have called for women be screened for depression during pregnancy and after giving birth.

Their claims, according to the NYT, "comes in the wake of new evidence that maternal mental illness is more common than previously thought; that many cases of what has been called postpartum depression actually start during pregnancy; and that left untreated, these mood disorders can be detrimental to the well-being of children."

The panel gave its recommendation, which was published in the journal JAMA, a “B” rating, which means depression screening must be covered under the Affordable Care Act.

In the NYT feature a woman/mother is quoted, seemingly to support the call for "maternal mental illness."

Melissa Mead, 30, of The Dalles, Ore, tells the NYT that shortly after her son Brady’s birth, she experienced postpartum depression, anxiety and O.C.D. In her own words she "cried continually, barely slept, rarely left home and was scared to death that my baby was going to suffocate."

Hello!

Isn't this a normal response to giving birth, isn't this just a motherly instinct?

The NYT goes on to say that...

After a year, she saw a psychiatrist for talk therapy. When her second son, Emmett, was born, and she had more symptoms, including fearing that she would stab herself with a kitchen knife, Ms. Mead tried several medications until one worked. She now volunteers for Postpartum Support International.

Several medications until one worked? Are we led to believe that some of them didn't work? Shock, horror, you mean some antidepressants don't work?

Mead is now a volunteer for Postpartum Support International (PSI), an organization whose purpose it is to increase awareness among public and professional communities about the emotional changes that women experience during pregnancy and postpartum.

In 2015 the PSI and Tree of Hope Foundation held their Annual Conference. The conference theme was "Planting seeds of hope: overcoming stigma, increasing options and embracing innovative treatments."

Ah, there's that word - "treatments."

Because the NYT featured a woman's story to support the calls for more screening for women with "maternal mental illness", I thought I'd throw in a story about the kind of treatments used to treat mothers during pregnancy.

Lundbeck's Celexa (citalopram) is one such treatment.

Back in 2013 Scottish mom, Cheryl Buchanan, wrote a guest post for this blog. It was with regard to the birth defects caused to her unborn child. Cheryl aborted her child at 23 weeks after being told that the fetus had severe abnormalities which meant she was incompatible with life.

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl.

Scans had detected a series of anomalies in her unborn child, namely...

  • Diaphragmatic hernia or eventration
  • Long bone immobility
  • Cystic hygroma 
  • Unilateral cleft hand
  • Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

  • (Foetal death in utero) - drug related - possible
  • (Pulmonary hypoplasia) - drug related - possible
  • (Diaphragmatic hernia) - drug related - possible
  • (Hand deformity) - drug related - possible
  • (Skin laxity) - drug related - possible
  • (Skin swelling) - drug related - possible
  • (Drug exposure in utero) - drug related - possible


The actual documents can be viewed here.

Now, I'm sure many people get the cold shoulder treatment when diagnosed (labelled) with a mental illness - but is there really a stigma attached to it?

I'll go out on a limb here and suggest that there is more of a stigma attached to people like Cheryl Buchanan speaking out against the use of antidepressants during pregnancy - people like Cheryl are deemed irresponsible for taking the stance that she has - normally by healthcare professionals and those who wish to believe that antidepressants are safe during pregnancy.

You want facts?

During the citalopram animal reproduction studies it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Meantime, more calls for screening women for mental health illnesses is being touted in the widely read New York Times. If you think the pharmaceutical companies, including Lundbeck, aren't behind this latest push then think again.

Both stories call for more help with the stigma associated with mental illness, of course they do - Big Pharma have something to sell and they want you in their corner helping them push their drugs on unsuspecting mothers.


Bob Fiddaman



















    

Two Former Glaxo Scientists Charged With Trying to Steal Data






It never rains but it pours for poor old Andrew Witty. Last week it was learned that he had been implicated for ignoring the claims of an employee that dishonest study data was used to promote the effectiveness of a smoking-cessation product, NiQuitin. And now the company that he is CEO of are (yet again) in the news.

It appears that the dust hasn't yet settled in China and two former scientists at a GlaxoSmithKline research facility in Pennsylvania have been indicted for allegedly scheming to steal data on an in-development cancer drug from the research facility and sell them in China.

Yu Xue and Lucy Xi were scientists working at GSK's research facility in Upper Merion, Pennsylvania and had allegedly engaged in a scheme to steal GSK research data, procedures and manufacturing processes for biopharmaceutical products.

Xue, it is alleged, emailed confidential information from her GSK email account to her personal email account so she could then forward it to Li and Mei, two of three others named in the complaint, with whom she, in 2012, founded Chinese companies Renopharma Inc., Nanjing Renopharma Ltd. and Shainghai Renopharma Ltd.

Although this doesn't show GSK in a bad light it does beg the question about the security at GSK.

The indictment charges all five people with conspiring to fraudulently obtain property from GlaxoSmithKline, theft and wire fraud, according to Business Insider.

It's a pity we don't get Glaxo employees trying to steal GSK's procedures for researching, developing and manufacturing other products, Paxil and Wellbutrin for example. Or maybe more of their reps coming forward and blowing the whistle on the illegal promotion of these two particular antidepressants.

So, already in 2016 we have two news stories featuring British pharmaceutical giant, Glaxo. One showing that dishonest study data was used to promote the effectiveness of NiQuitin, the other for showing how two of their own employees breached security and tried to pass off trade secrets.

Ah well, they're getting better - at least no kids have died as a result of their latest shenanigans.

Bob Fiddaman.






    

More Recent Articles


You Might Like

Click here to safely unsubscribe from "FIDDAMAN BLOG."
Click here to view mailing archives, here to change your preferences, or here to subscribePrivacy