Medical Power Over the Innocent - Part 3
I was hoping that the third instalment of this story would be the last one and that at this point, I could tell you that the entire situation was over and Sara and her girls were safely past this stage of their lives. Unfortunately, things are rarely as simple as we want them to be or think they will be.
Sara was in an open ward with no privacy and without being able to even go up the hall without a guard to accompany her.
On Friday morning, thanks to the intercession of the Ombudsman’s office, Sara was visited by a representative of the Health Care Complaints Commission (HCCC) regarding her complaint about the hospital treatment. This official spent 3 hours with Sara and with hospital staff.
As a result of this visit, Sara was moved to a private room where, despite the fact that she had a guard (they called this person something else – I can’t recall – but guarding Sara was their job) outside her door 24/7, she at least had some privacy and quiet.
It appeared at this time that the hospital’s main concern was with the baby’s weight gain.
As noted earlier, the baby was born outside of the hospital system and only came to hospital because her mother was sick. Below is a list of weights for this baby from the time of admission.
Friday 27/8 Born not weighed
Saturday 28/8 3680g
Sunday 29/8 3930g
Mon 30/8 3940g (day Sara first contacted me)
Tues 31/8 not weighed
Wed 01/9 3960 (night Sara left hospital)
Thurs 02/9 3890
Friday 03/9 3930
Monday 06/9 3910 (Medical treatment)
Wednesday baby must weigh at least 3950.
In general, it is considered that fully breastfed babies lose more weight in their first days then those who are fed artificial breast milk (ABM). It is considered normal for a breastfed baby to lose between 7 and 10 percent of their birth weight and to take between 2 and 3 weeks to regain it. In other words, it is within the range of expectations for a fully breastfed baby not to regain their birth weight for up to 3 weeks. This would not be a cause for concern in most cases.
As shown above however, Sara’s baby has not only regained her weight, she has been growing quite well with some normal fluctuations in weight which could be accounted for by differences in scales, whether or not she has emptied her bladder just before being weighed and how long since her last feed at the time of weighing.
Despite this growth which would normally be considered to be excellent, the paediatricians in the hospital said that Sara’s baby was at risk because she was not gaining weight quickly enough.
A hospital Lactation Consultant (LC) was brought in and a judgement was made that Sara was not producing enough breast milk and that her production needed to be enhanced. The plan (reproduced below) called for Sara to feed every 3 hours and to express after each feed so that a top-up of at least 30mL could be obtained which could then be given to baby after feeds since her weight gain meant (according to the hospital) that she was at risk of not growing well on mother’s breast feeds alone.
Just a personal anecdote here. I have 4 children – all of whom were breastfed for between 9 months (my first) and 3 ½ years (my youngest). Feeding did not come easy for me and I had problems after each birth. It generally took 2 months before feeding was properly established and became ‘easy’. During this time, I would have mastitis a couple of times during what I called times of ‘feast or famine’ – too much milk or not quite enough. It took me that long to establish my supply and from my days as a Nursing Mothers’ Community Educator, I found that this was not at all unusual. In addition, each baby grew at a completely different rate. My first child was lucky to gain 50g a week - my second was gaining 500g a week - same mother, different children.
For one of my children, I had to express for 7 months straight because I was diagnosed with thrush which, despite fissure after fissure every time I tried to get baby back onto the breast, was finally swabbed and found to be golden staph, not thrush. It was determined that I would most likely have gotten this from my baby in hospital – probably because the nurses gave my baby a dummy one night even though I had a written plan saying no dummies. They say they did this because they wanted to let me sleep!
In any case, I had a baby that fed every 2 hours day and night for the first 6 months of her life and it was hell having to pump and get enough milk to keep her happy. I called myself the Queen of the Medela (a brand of breast pump) and would try and meditate and relax before pumping because any stress would mean no or low milk supply.
The reason I tell you this is to let you know how amazing Sara is. Sara was in the most stressful situation you could possibly imagine. Not only was she in hospital against her wishes, her baby had been made a Ward of the State and she was under the constant threat that if she didn’t ‘produce’ enough milk, her baby would be force-fed formula – something that her research has shown could cause health problems.
Despite this, she was able to feed her baby every 3 hours and express 50mL or more after feeds which was then used for top-ups.
But this was not good enough. Sara was told that she needed to take a drug called Domperidone. I had never heard of this so Sara asked me to look it up and speak with the (LC) about it.
My first search for the drug turned up the following information which I then related to the LC.
Lactation
The hormone prolactin stimulates lactation in humans, and its release is inhibited by the dopamine secreted by the hypothalamus. Domperidone, by acting as an anti-dopaminergic, results in increased prolactin secretion, and thus promotes lactation. Since, according to the U.S. Food and Drug Administration (FDA), domperidone is not approved for enhanced lactation in any country,[6] it is sometimes self-prescribed from original research or prescribed "off-label" for this use in countries around the world.[7]
Controversy
Janssen Pharmaceutical has brought domperidone before the FDA several times in the last two decades, with the most recent effort in the 1990s. Numerous U.S. clinical drug trials have demonstrated its safety and efficacy in dealing with gastroparesis symptoms, but the FDA turned down Janssen's application for domperidone, even though the FDA's division of gastrointestinal drugs had approved domperidone.[8]
In June 2004, the United States' main regulation agency, the FDA, issued a letter warning women not to take domperidone, citing unknown risks to parents and infants, and warned pharmacies that domestic sale was illegal, and that import shipments from other countries would be searched and seized. Domperidone is excreted in breast milk, and no studies on its effects on breastfeeding infants have been reported in the literature. Individual incidents of problems with the drug include cardiac arrest and arrhythmia, complications with other medications, as well as complications with improper intravenous use[7]. A recent paper suggests there may be increased risk of seizures to neonates of mothers taking oral domperidone[9].
Some doctors and pharmacists do not fully accept the FDA's reasoning and still favor domperidone's use in increasing milk supply. Such doctors and pharmacists claim the drug is safe in the doses given for this purpose but have no evidential data or studies to base their claim.[10] The American Academy of Pediatrics considers domperidone "usually compatible with breastfeeding".[11]
There is a new controversy in Britain regarding lethal levels of sodium found in children who are administered this drug. It is now subject to a medical review following a number of criminal trials where parents were charged with child abuse by salt poisoning based on hypernatremia in the affected children.[12] Recent studies also cite increased QT intervals in neonates taking Domperidone. [13].
In other words, Domperidone was banned in the US in 2004 because it was deemed to be simply too dangerous to use in anyone – especially in breastfeeding women. It was considered so dangerous that the FDA – an organisation that is not particularly known for their strong stance against drug companies – stated that they would seize and destroy any shipments of Domperidone that came into the US from overseas!
The LC had never heard any of this and said that it was a routine drug given at the hospital for any woman who had problems producing enough breastmilk.
Aside from the fact that Sara did not seem to fall into that category, the hospital was telling her that she had to take this drug against her wishes or have her baby formula fed. This did not sit well with her.
Luckily, the Ombudsman had contacted the Health Care Complaints Commission (HCCC) on Sara’s behalf and a representative came to the hospital and spent 3 hours with Sara going over her treatment, her concerns about her baby and the lactation plan. The representative stated that Sara had the right to know about all of the available treatment options for increasing milk supply – drug and non drug – and that she would not be forced to take a drug she did not want to take despite the hospital’s saying she had to.
Sara started on fennel, fenugreek and raspberry leaf tea and was drinking large quantities of this to keep her milk supply up.
In the meantime, I was able to do some more research into Domperidone using MIMS – the Australian publication that provides health professionals with prescribing details on all currently-licensed drugs (and non-drugs – many natural remedies are also listed in MIMS).
Some of you may recall that the AVN used to have the package inserts for Australian vaccines on our website but that we were asked to remove them because they are under copyright with MIMS. So now, we link to the NZ Ministry of Health website where this information is freely available.
Because of these restrictions, I can’t put the entire Domperidone package insert here, but I can share relevant sections with you and I think you will agree that it is curious to say the least, that this hospital (and perhaps others in Australia as well) would be using this dangerous drug in women who had just given birth and who, for some reason, were deemed not to be producing enough milk. (Please note – in Australia, Domperidone is also called Motilium)
MIMS Abbreviated Prescribing Information
Domperidone
Janssen-Cilag
Section: 3(h) Antiemetics, antinauseants - Central Nervous System
Product Images: Motilium 10 mg
Use in pregnancy: B2
Permitted in sport
Use: Dopamine antagonist with antiemetic properties. Short-term (less than or equal to 6 mths) treatment of symptoms assoc with idiopathic, diabetic gastroparesis; intractable nausea, vomiting from any cause in adults
Contraindications: Prolactin releasing pituitary tumour; concomitant oral ketoconazole, erythromycin, other potent CYP3A4 inhibitors which prolong QTc interval eg fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin; where GI motility stimulation may be dangerous eg GI haemorrhage, mechanical obstruction, perforation
Precautions: Breast cancer history; renal (serum creatinine > 0.6 mmol/L), hepatic impairment; long-term use (> 6 mths); QTc prolongation risk factors eg hypokalaemia, severe hypomagnesaemia, structural heart disease, genetic predisposition; lactose intolerance, galactosaemia, glucose/ galactose malabsorption (lactose content); pregnancy, lactation
Adverse Reactions: Dry mouth, headache; incr prolactin level; endocrine disturbance (eg galactorrhoea, amenorrhoea, gynaecomastia (rare); impotence); extrapyramidal reaction (rare); QTc prolongation, convulsion (very rare); others, see full PI
…Use in pregnancy. (Category B2)
Small amounts of Motilium have been found in rat fetal tissues. Reproduction studies were performed in rats with daily doses of Motilium up to 160 mg/kg orally and 40 mg/kg intravenously and in rabbits with daily doses up to 40 mg/kg orally and 1.25 mg/kg intravenously. There was no evidence of drug related dysmorphogenesis. There are, however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human response and there are limited postmarketing data on the use of domperidone in pregnant women, this drug should be used during pregnancy only if clearly needed.
Use in lactation. The drug is excreted in breast milk of lactating rats (mostly as metabolites: peak concentration of 40 and 800 nanogram/mL after oral and intravenous administration of 2.5 mg/kg respectively). This probably also occurs in humans. It is not known whether this is harmful to the newborn infant. Therefore, breastfeeding is not recommended for mothers who are taking Motilium. (emphasis added)
To cut through the medical-ese, Domperidone is licensed in Australia though it was banned by the FDA in the United States and in other countries around the world. Even though it is licensed here, it is not licensed for use in breastfeeding women. In fact, it is not recommended for breastfeeding women because it is linked with a very large number of serious and potentially fatal side effects in both the mothers and the babies.
Over the last few days since I started posting Sara’s story on the AVN’s blog, I have gotten a lot of flack from members of SAVN. Who am I to question what a doctor has done? What qualifications do I have to ask about these things? And why did the mother not just do what the doctors have told her to do? Why does she feel that she has the expertise to make these sorts of choices when the doctors, with all their years of training, believe that what they are doing is for the best?
The Ombudsman and the HCCC both stated that they can investigate the way in which Sara was treated but when it comes to her baby and any medical issues, there is nothing they can do. It seems that there is nobody who can oversee the treatment meted out by the medical community. And that is not right.
As you can see from the one example above, here is the medical community prescribing a drug that is known to be dangerous for mothers and babies and which is not licensed in Australia for this purpose (called off-label prescribing). Bad enough they are doing this – but the LC admitted to me that she had not seen this information before and did not really show any concern when informed of these issues. One has to wonder what they are basing their decisions on if they have not even read the manufacturer’s information for the drugs they are handing out. And if Sara had not asked questions about this – as most mothers seem to not ask questions – and she or her child had suffered a heart attack, stroke or seizures – what are the chances that the reaction would have been traced back to the drug or reported?
In addition, looking at the child’s weight gain and showing it to several health professionals both here in Australia and overseas, it appears that based on weight alone (of course, these doctors could not examine the baby so that is all they had to go on), there was no apparent reason to be concerned about the baby’s nutritional status.
I did put out a call for paediatricians to share with me any information about IV antibiotics leading to malabsorption or leaky gut, causing slow weight gain or weight loss.
Below is an email from a toxicologist and pathologist from the US.
Dear Meryl:
The antibiotics given can cause kidney damage, bone marrow damage, vitamin K deficiency and bleeding, and diarrhoea. They need to do a blood analysis to check for kidney functions, anemia and bleeding disorders. The baby can lose weight due to kidney damage, gastroenteritis, diarrhoea, and anemia and these can be caused by the antibiotics. Hepatitis B vaccines can cause gastric acid reflex and restriction of growth. I explained these medical problems in several articles published in Medical Veritas and posted on toxi-health.com.
Sincerely,
Another health professional sent me the following:
http://www.ncbi.nlm.nih.gov/pubmed/20639777
Meryl.
There is a lot of information on antibiotics causing gut problems in infants. I am not a pediatrician but an adult internist/nephrologist. But I found the above article. Disturbance of the bowel flora is a known cause of leaky gut and malabsorpiton. And of course that would lead to rapid weight loss in an infant. Hope this helps.
So, if this baby’s weight gain was slow (and it doesn’t appear to have been) or inconsistent, it could very well be as a result of the IV antibiotics that she was given against her mother’s wishes.
And if this is the case, the mother’s milk was not insufficient or ‘inadequate’ in any way. Yet Sara was blamed for this and was made to feel deficient as a result.
The mother-baby breastfeeding relationship and bond is incredibly strong – yet incredibly fragile too. It doesn’t take much to put chinks in this wall a mother builds around her baby and herself. The hospital in this case appeared to be doing everything they possibly could to spoil this relationship.
Sara was told that her baby would be woken up every hour at night to be ‘observed’. This meant that Sara was also woken up every hour at night.
The top-up milk was being cup-fed to the baby by nursing staff who were not experienced with this sort of feeding and Sara said that they were rushing so much that the baby was choking and screaming through the whole feed.
There is so much more that I could share with you, but at this point, I will leave this story here.
Sara and baby are now out of hospital but still under observation. Sara is required to present her baby for weighing on Friday this week at the hospital. If baby has gained 150g (an almost impossibly tall order in only 4 days), they are free to go. If less then that, the baby will be re-admitted for ‘checking’. If less than 120g, the baby will be readmitted and fed formula through a nasopharyngeal tube (a tube that goes in through the baby’s nose).
They have set Sara a virtually impossible task and she is not sure of what to do. Since leaving hospital, Sara has visited with a very experienced paediatrician who was not told about this baby’s background but was just shown the chart of weight gain. He was asked if he would be concerned if a baby he was caring for showed this pattern of weight gain and loss and he said that this was well within the normal range and he would not be worried.
One has to wonder why Sara and her baby have had to go through this torture (her words) at the hands of the very people who should be caring for them and respecting their wishes whenever and wherever possible.
I will try to update this information next week if I am able to but if I don’t, I hope you will understand.
Many of you have asked what you can do to help Sara. At this point, there is probably very little that can be done. But there may come a time in the very near future when Sara and her lawyer may start to discuss legal action and if this won’t be covered by Legal Aid, it may be necessary to consider raising funds for this action that will (hopefully) lead to a change of policy for the entire State where this occurred. If so, I will let you know and hopefully, we can assist with that. It will be to everyone’s benefit if this case is won.
In closing, I would like it understood that this story is in no way meant to be an attack on Western Medicine. Hospitals are necessary and doctors do good work.
The issue is when doctors feel that their medical opinion must take primacy over the parents’ decision-making process. That is not the role of medicine. Doctors make mistakes. Things which are accepted as medical fact one day are overturned as fallacious the next.
When it comes to the health of a child, the parents must always have the right to decide what is best after open and transparent discussion with the health practitioners of their choice. After all, it is always going to be the parent who will be dealing with the day-to-day care of their children and parents who care the most about that child’s health, happiness and future.
While there are some unfortunate families where children suffer at the hands of abusive and neglectful parents, this is the exception rather then the rule. Doctors and Family Services organisations across Australia need to realise this and to treat parents with the respect they deserve as the guardians of their precious and beloved children.