Since 2005, Paroxetine, first marketed by GlaxoSmithKline as Seroxat/Paxil, has carried warnings of birth defect risks. These risks led to litigation in the US – but not elsewhere. In the first case that went to court in the US in 2009, the Kilker case, the lawyers for Lyam Kilker argued that, even before Paxil was launched, there was good laboratory evidence that the SSRIs might cause problems, and, that following their initial marketing, further evidence had emerged steadily from 1998 onwards painting a consistent picture that the drugs actually do cause problems in clinical use, and of company efforts to hide this.
Yet since their launch Paxil and other SSRIs have been actively and increasingly promoted to women of child-bearing years. The company most committed to this and most effective at it was Glaxo. This is ironic in that the company began in New Zealand as the makers of formula milk for babies – from which they derived their name.
Women of child bearing years in particular who have nervous problems have been encouraged to go to their family doctors where they are all too readily put on an SSRI. These family doctors aren’t aware of the risks of dependence or birth defects, and so don’t warn. The patients become dependent on the SSRI and find it impossible to stop using it when they wish to get pregnant or if they find they are pregnant. In an age where most women will abstain from alcohol, nicotine, tea, coffee, soft cheeses or uncooked meats if they are thinking about becoming pregnant, few of these women would consent to treatment if informed of either the risk of birth defects or the risk of becoming addicted (see We need to talk about doctors).
What we are seeing here is the astonishing marketing power of pharmaceutical companies, which can now bring about huge changes in medical culture within months. In this case, a great part of the scientific literature (the primary marketing tool of companies) on the use of antidepressants in pregnancy and on dependence on antidepressants is ghostwritten – just as virtually all literature on giving antidepressants to children was, at one point, company or ghost-written.
Because of this, even the most independent guideline makers like NICE, who can only go by the published literature, are trapped. Regulators, like the FDA in the US and MHRA in the UK, which reflect a professional consensus rather than lead on issues like this, are likewise maneuvered into a corner. Doctors, who should be leading and who until recently would have been hostile to the idea of taking antidepressants in pregnancy, believe their role is to follow NICE, the FDA and what appears to be the scientific evidence and have failed to spot how they are being groomed.
The process of manufacturing clinical consensus has become so slick that it is now almost impossible to find independent articles from academic physicians that will sound a note of caution about prescribing antidepressants to women of child-bearing years. This is a problem that increasingly applies across all of medicine – from the use of drugs for osteoporosis, respiratory or gut problems, or for pain-relief, as well as all psychotropic drugs.
Where once drugs were seen as poisons to be used judiciously and with caution, they are now treated as fertilisers whose more or less indiscriminate use can only do good.
And here’s the rub. In these legal cases, the laywers for GlaxoSmithKline took care to ask any of the women who were suing whether they had had St John’s wort (Hypericum). If they had they were likely to face an action from the company to get their case thrown out on the basis that this serotonin reuptake inhibiting plant had been known for centuries to cause birth defects.
Farmers regard St John’s wort as a dangerous weed and know to keep their cattle and sheep out of fields in which the weed grows for fear of miscarriages. But under industry influence doctors have been used like the dogs a farmer uses to round up sheep to herd women in exactly the opposite direction.
There are roughly 700,000 births in the UK each year, 4 million in the USA. Close to 10% of these, 70,000 in the UK and 400,000 in the US, will now be to women on antidepressants. Normally 2% of women give birth to a baby with congenital defects. So there should be 1400 babies with congenital defects born to women on antidepressants in the UK, 8000 in the US, but in fact the figures show that 3% or more of the babies born to these mothers, 2,100 in the UK and 12,000 in the US, will have major congenital defects.
There are likely 50-60,000 miscarriages in UK each year, 400,000 in the USA. In women on antidepressants this rate appears close to doubled – so what would have been 5-6,000 miscarriages in women on antidepressants will more likely be 10,000 in the UK, and 40-50,000 becomes something closer to 80,000 in the USA.
There will also be a substantial increase in voluntary terminations of pregnancy. This can happen for a few reasons. In some countries, any evidence of neural tube defects or other major congenital abnormalities automatically leads to a termination (see American Woman, and American Woman 2). In other instances, the disinhibiting effects of SSRIs may lead to a woman having a termination she might not otherwise have.
There are roughly 250 terminations per 1000 live births. In women on SSRIs this likely rises to somewhere around 400. A very high proportion of terminations after 16 weeks are likely to be women on or previously on SSRIs, for reasons outlined above.
Glaxo began life making baby milk. SmithKline were once SmithKline Beecham. Beecham made their early money out of Beecham’s Pills. Slightly over a hundred years ago they were censured by the British Government for apparently promoting their pills for “maladies of indiscretion” – they would induce miscarriages.
Ah, NICE guidlines! I wish doctors- psychiatrists in particular-wouldn’t follow them always so blindly. I suppose they feel safe with them: they don’t have to take responsability for what they are doing. They can always blame NICE guidlines if things go wrong. Also they don’t need to think for themselves which takes time: just follow the rules-medicate them!
I hope and pray we don’t see more government intrusion into healthcare here in the United States… We already have plenty!
A NICE Program, by any other name, hardly sounds NICE!
“If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.” – Thomas Jefferson
The U.S. federal government has failed the people and the states… partnering with drugmakers, rather than providing oversigt and protection… from the FDA to the NIMH.
And now we are blindly following this same centralized, bureaucratric broken “leadership”… first comes Obamacare, which will lead to a complete federal system… with more power and control to the feds… Telling us what foods to eat, what medicines to take.
“Baah, baah”… as a free people become sheep!
And more force in psychiatry, with failed and dangerous drugs!
As an Englishman I find these arguments about Obamacare always leave me slightly confused. We have a National Health Service which has provided free health care to everyone. Canada has even less private medcine that we ever did. It did the job well and is liked. Generally we are proud of the NHS.
Over the last 30 or so years has been softened up for privatisation and is now, under the present government being opened up to private health care providers. We are moving towards a more USA form of health provision (a generalisation that some may criticise -please do).
The mental health system in the UK is similar to the USA, and indeed most of the developed world, in it’s use of drugs, but much less aggressive than the USA. There are less people on these drugs in the UK than in the USA but the system of care is mainly, though not entirely drug based. GP’s also prescribe these drugs in large numbers, but as I understand it no where as freely as in the USA>
AS the NHS is spit up, marketised and prepared for privatisation, and as the beginning of privatisation happens, there are some serious, though anecdotal, signs that the mental health system has got worse with more aggressive drug use, more forced drugging, more “Early Intervention, etc etc. The drug model is easier for a managerial class to measure and charge for and the drug companies find it easier to influence the private, or semi-private healthcare providers.
Healy’s article highlights the influence of the the drug companies over clinical decisions. These are private companies. They are some of the biggest corporations on the planet with huge PR and marketing divisions through which they influence clinical decisions.
The two main influences of Psychiatries bad treatment of the mentally distressed has two important threads. One being the way Dr’s have tried to use medical explanations and treatments of the mentally distressed as outlined in Whittaker’s book Mad in America. The other being the power of drug companies as outlined in Whittaker’s book, Anatomy of an Epidemic.
Nationalised health systems, such as the UK has, but maybe on the way to loosing, have never completely freed themselves of the dangerous influence of private, profit driven drug companies. But perhaps the more a country allows there influence the more harm they do?
A comparison of psychiatric drug use between countries with private and state health care systems might be interesting?
You make some good points, especially about the influence of profit-driven drug companies.
I’m not fan of the runaway train we see here in the U.S. when it comes to the cozy relationship between the drugmakers and the FDA. It certainly is not a free market. It’s “cronie capitalism” at best.
Also, I’m all for a safety net for seniors, people with disabilities, working poor, and others.
There has to be a way to allow the free market to work, while ensuring some compassionate care for those who truly need help. My point is that the FDA is not doing its job, and because it is perceived to be regulating and making sure drugs are safe and effective… this perception causes more harm than good for the drugmakers to continue to slaughter people with psychiatric drugs. And “slaughter” is not too strong a word when it comes to drugs like neuroleptics, especially for the long-term as “maintenance medication.”
I hope I didn’t take the subject to politics. My point is that people ought to be free to make their own decisions… with adequate information… the facts about psychiatric drugs.
I would like to see a comparison, as you suggested.
Thank you for making some good points about the drugmakers.
“Since 2005, Paroxetine, first marketed by GlaxoSmithKline as Seroxat/Paxil, has carried warnings of birth defect risks.”
“These family doctors aren’t aware of the risks of dependence or birth defects, and so don’t warn.”
How do these two things line up? There’s a birth defect warning label on the drugs, but the doctor’s allegedly aren’t aware of the risks?
Taking any drug is a risk. Why don’t people take personal responsibility for the risks? Now there’s an idea that won’t be popular on this thread.
The problem is that Americans in general don’t want to take responsibility for anything. I learned that when I taught high school for fifteen years. You are correct, it is the job of each and every one of us to find out about what we are going to poke down our throats. If we can’t be bothered to do so then we have no business to try and hold doctors responsible. I had to learn the hard way. I originally was treated by my GP for high blood pressure. Then I went whining to him for SSRI’s when I became sad. He put me on Effexor, which is well known for causing very high blood pressure. So, I got a double whammy. But, I deserved it becuse I didn’t inform myself about the blood pressure medicine nor the Effexor. I really only had myself to blame for the problems that resulted.
Anonymous! You are correct in that people do not take responsibility for themselves, as there has been societies abound that could have given patients information on abuses, lies, etc. And one for 30 years and more too. The problem of words bring about a host of scientific screens and people leave it to the experts who are trusted, but these people are not to be trusted. Dr Walluch is to be applauded for his eye-opening statement, in http://www.deaddoctorsdontlie.com
Re: Personal responsibilty
I agree, every person needs to accept personal responsibility, and reading the warning label on a drug is a good place to start.
The problem is that the drugs claim to “correct chemical imbalance” in the brain, and so the person reading the label may be apt to want to balance the “benefit versus risk”… Whereas, the reality is that the drugs do nothing to correct the imbalance, in fact they interrupt healthy brain function.
The warning label should state the following: This drug does not correct chemical imbalance, and in fact is likely to cause an imbalance, leading to interruption of healthy brain function.
Also, the warning label only contain information made available during the FDA approval process, which often involves very short clinical trials – several weeks, or a couple of months. Long-term risks are not on the label, because they are not known for decades. Even emergency rooms are not providing the kind of feedback necessary to truly monitor the drugs’ effect in the long-run.
So, in spite of the fact that a free market requires personal responsibility on the part of the buyer, the seller has been able to frauduently market the drug to the consumer as something it is not.
The FDA has failed to give the consumer any idea of just how utterly worthless and dangerous these drugs are… Those facts are not on the label.
And in fact, many of those facts are not fully known to the doctor, especially general practitioners, or others who specialize in areas outside psychiatry.
Although, I suspect the vast majority of psychiatrists are in absolute denial of the harm they cause. Their heads are intentionally in the sand – for the sake of their professional lives and their own sanity (or lack thereof).