Thursday, July 04, 2013
Panorama - Antidepressant Birth Defects
Earlier this week the UK flagship programme, Panorama, exposed the link between a group of prescription medications and birth defects. The programme, "The Truth About Pills and Pregnancy", highlighted the epilepsy drug, Epilim (Sodium valporate) and the group of SSRI drugs.
"The Truth About Pills and Pregnancy" focused on two of the SSRi group, namely Cipramil (citalopram) and Seroxat (paroxetine).
Much of what was covered by investigative journalist, Shelley Jofre, has been written about before but rarely do we get the chance to see this controversy on our TV screens.
I'm left wondering if prescribing physicians will see it as putting women off taking medications during pregnancy, this has a tendency to make GP's dig in their heels because professionals hate to be told that they are wrong, they hate to be told that there is research out there that they have missed... overlooked.
Panorama, once again, showed exactly how the pharmaceutical companies, in this case, Sanoi Aventis [Epilim], GlaxoSmithKline [Seroxat] and Lundbeck [Cipramil] deny any link between their products and birth defects. Jofre, who rose to fame for investigative work on Glaxo's Seroxat, also interviewed Dr June Raine, the MHRA's Director of Vigilance and Risk Management. In the past (Panorama Seroxat expose) the MHRA mouthpiece was Alasdair Breckenridge who performed less than adequately in front of camera. Did Raine perform any better? Not really, once again it was all spin and deniability.
The yellow card was touted once again, a system designed to collect adverse reactions to medicines and to protect the public from harm. I don't even believe the MHRA think their yellow card reporting system is robust enough to be the be and end all of dodgy medicines on the market. In any event, children born with defects are just unlucky, right? They are just unfortunate because... well, because shit happens.
Shit is only happening because it's shit that is in charge. However they spin it one must always remember that one cannot polish a turd, something the MHRA have been trying to do for years, particularly where SSRI's are concerned.
The antidepressant/birth defect link has been debated for years. We have those who claim untreated depression in mothers can harm the child, maybe so but there is no evidence that mothers taking antidepressants protect their unborn children by taking these drugs. Yet health professionals globally still prescribe them.
If an illness such as depression in an expectant mother can harm a foetus, does it harm them in such a way that they are born with heart defects, cleft palate or skull deformities?
These are physical changes to the human body caused by the chemicals ingested during pregnancy, we saw it with thalidomide and have been seeing, but ignoring, it for almost two decades with SSRIs.
I don't really buy into this tough decision health professionals have to make, this nonsense about weighing up benefits against risk just doesn't wash with me any more. They should not be weighing up benefit against risk when they don't even have the full facts to compare. Facts, such as the early rat studies [1979/80] carried out on paroxetine - those rats given paroxetine gave birth to pups who all died four days after they were born, while 80% of the pups not exposed to paroxetine were still alive on day four. Surely this should have rang alarm bells or, at the very least, warranted more animal studies. Fact is it didn't, it was brushed under the carpet, seen as something minor, shit happens, right?
When a pharmaceutical company carries out tests on animal subjects they sing from the rooftops when they see a benefit. When they see a risk they bury such data. They do not choose to weigh the two against each other, why would they wish to do something that could harm sales? Harming babies is okay though, just a small price to pay in this billion-dollar market.
The phrase "informed decision" has been used many times throughout the past 10 years or so that I actually think we have got to the stage where it means nothing, it's just a phrase associated with campaigners, activists or conspiracy theorists. Many won't even know what it means or will accept information given to them by healthcare professionals as everything that needs to be known on the subject. Healthcare professionals tend to quote published studies to concerned patients, studies that have either been funded by the pharmaceutical industry or written by the pharmaceutical industry who later disguise that work as being written by somebody else, usually an expert. Experts who put their names to papers written by the pharmaceutical industry take the back-slaps, along with big payments for being a good sport. It's these weasels who convince doctors that taking antidepressants during pregnancy is quite safe.
One can only make an informed decision when one has all the facts. Truth is, patients never get all the facts - how can they when their own doctors don't?
"The Truth About Pills and Pregnancy" highlighted that almost 20,000 children could have been effected by the epilepsy drug, Epilim. Given that an estimated 1,000 were effected by thalidomide I think it's high time regulators removed their fingers from their backsides and grew a pair. Alas, this is just not going to happen. The MHRA rely on funding from pharmaceutical companies, they rely on expertise from pharmaceutical companies and, in many cases, employ ex-pharmaceutical employees, case in point Alasdair Breckenridge and Ian Hudson, both, at some point in their careers worked for GlaxoSmithKline, or Smith Kline Beecham as they were known then.
Doctors, for their part, maybe have a 10 minute window. A patient will present them with evidence, the doctor will tick boxes and then make a dignosis based on the number of ticks.
In New Zealand, for example, most doctors use PHQ-9, a patient health questionnaire, which carries 9 opportunities for doctors to tick boxes. The patient never gets to see this. Most of the questions relate to if the patient has a poor appetite to if they are overeating, if they are having trouble sleeping or sleeping too much, if they are having trouble concentrating etc. Most, if not all, the questions relate to all of us, probably even the doctor who is running the test on you.
So your doctor allocates you points based on your answers and his observations.
What may surprise many is that the PHQ-9 (patient health questionnaire) is copyrighted to pharmaceutical giants Pfizer, the company that manufactures and markets the antidepressant Zoloft (Sertraline)
Antidepressants are advertised on TV in New Zealand, the only other country that allows this is the United States. The 'other' types of adverts run on TV in New Zealand are letting the public know that it's okay to talk about depression. These ads have a famous face. Ex All Black John Kirwan being the most recent voice/face. Kirwan was, in 2007, appointed as an Officer of the New Zealand Order of Merit for services to mental health and I'm sure, whether he knows it or not, has helped the sales of antidepressant medication.
Taking antidepressants during pregnancy is a hot potato. For expectant mothers it's akin to playing Russian roulette. Their child may be lucky and be born defect free but this does not mean they are out of the woods.
Sudden Infant Death Syndrome (SIDS)
SIDS, more commonly known as cot death or crib death, is not a medical cause of death, rather a statement that the cause of death is unknown. In fact, SIDS, is yet another of those hot potatos as nobody can pinpoint why infants suddenly die when there is, apparently, nothing wrong with them. Some of the theories that exist have been debated and disproved. Bacterial infections, bed sharing, inner ear damage, Nitrogen dioxide exposure, toxic nerve gases emitted by mattresses, high levels of vitamin C have all been used as an explanation or reason for SIDS.
In 2009 Maria Bradshaw reviewed and researched SIDS, she found, "significant evidence that the harm caused to neonates by exposure to and withdrawal from SSRIs/SNRIs during pregnancy and after birth can lead to sudden infant death, mirroring those caused by illegal drugs."
Bradshaw found that an editorial in the British Journal of Psychiatry in 2003 reported the effects on neonates of illicit drug use during pregnancy. It identified exactly the same symptoms of withdrawal for babies whose mothers used cocaine and heroin during pregnancy as are identified in research on mothers using SSRIs/SNRIs during pregnancy.
So, most of us know how horrific withdrawal can be on these drugs. We, as adults, have had to endure the electric zaps, tremors, akathesia, suicidal feelings when withdrawing from these drugs - do babies exposed to these drugs during pregnancy experience the same? It would be ridiculous to say that they don't given that smoking and drinking is not recommended during pregnancy because both these substances can harm your child.
The MHRA are having their cake and eating it folks. On one hand they have a clear conscience because they have already told doctors that SSRIs should not be given to children or adolescents because they may induce suicidal thinking in this population. In other words, the risk outweighs any benefit. They are failing miserably in protecting expectant mothers. What the MHRA seem to be forgetting here [conveniently] is that it's not just one person ingesting the medication, it's two and one of them falls into the very same category (population) that the MHRA, after many years of thumb-twiddling, found that the risk of antidepressant exposure far outweighs any benefit.
Now, tell me again, what benefit does a child growing inside its mother receive from an antidepressant, indeed, tell me, if you will, what benefit a newborn receives from breast feeding when traces of antidepressants have been found in breast milk?
If you are an expectant mother and still undecided about antidepressant use during pregnancy then this simple test should help you arrive at your decision. If you feel the need to bathe your unborn child in serotonin then drop a bronze coin into a glass of Coke and see what happens.
"The Truth About Pills and Pregnancy" can be viewed below. It may only be available on YouTube for a short period as the material belongs to the BBC. I made the decision to upload it for the benefit of viewers outside the UK who cannot access the BBC IPlayer.