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.
Glaxo
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).
Grooming
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.
Eye of newt, toe of frog, leaf of Hypericum?
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.
How many birth defects, miscarriages and terminations?
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.
In the wake of being fined $3billion after criminal charges – not just civil – GSK has the audacity to publish the following:
“GlaxoSmithKline (GSK) is a leading research-based pharmaceutical company with a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better, and live longer. This mission gives GSK the purpose to develop innovative medicines, vaccines and healthcare solutions that help millions of people.” It would be gratifying to believe that a boycott of GSK might have an effect such as was tried, and is still going on, with Nestle. The Nestlé Boycott is the world’s largest ever consumer boycott, and is currently strongly supported in 20 countries around the globe.
Its history stretches back well into the 1970s, and the campaign has been taken up by hundreds of thousands of people over the years. The concept of the boycott is simple: Nestlé markets breast-milk substitutes unethically and with fatal results, and consumers refuse to let them do so without experiencing any consequences. The recent court case in the US determined that GSK is manufacturing products that have lethal results. Why should they pay no more than pocket change as the cost of doing business? Of course, finding the facts and refusing to ingest the potentially poisonous products is easier said than done. For example, it is almost impossible to buy any food product, except raw fruits and vegetables, that are not made by a company owned by Nestle. Nestlé owned 100% of Alcon, a global medical company specializing in eye care products. In 2008 Nestlé sold 24.8% of Alcon shares to the Swiss pharmaceutical giant Novartis. In 2010 Nestlé sold another 52% of Alcon to Novartis. Novartis paid a total of 39.1 bn US$.
Although undoubtedly difficult to achieve, a boycott is possibly the only thing that would have any effect – hit them where it hurts most – in the wallet.
Women led the Nestle Boycott and it would appear that women should bring GSK and other Big Pharma to their knees by refusing to ingest their products. A pipe dream, perhaps, but no less worth attempting.
Addendum:
I should explain that what I meant by a boycott of GSK (and other Big Pharma) is not just to refuse their medications but everything else they sell themselves and through subsidiary companies. At the beginning of the Nestle boycott, grocery shopping was very difficult because they owned Carnation, Palmolive, Crosse and Blackwell, Baxters, Libbys and a host of other foods. At the same time, we were boycotting South Africa because of apartheid and many fruits and wines were off limits. GSK produces and markets oral healthcare and nutritional products and over-the-counter medicines including: Beano;Boost;Eno;Horlicks;Lucozade;Ribena;Sensodyne;Tums;Gaviscon. It’s a pity they sell Gaviscon because it beats the daylights out of any of the PPIs so one has to look for an alginate made by another company. Boycotts take concentration, dedication and are, frankly, a pain at times, but they work.
I am rather confused. The article begins with the statement:
“Since 2005, Paroxetine, first marketed by GlaxoSmithKline as Seroxat/Paxil, has carried warnings of birth defect risks.”
Further on, it says:
“Women of child bearing years… 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.”
Why aren’t the family doctors aware of the risks? They should be! As you said, the medications carry product insert warnings about danger of birth defects. Also, the Physician’s Desk Reference lists the same counter-indications. Furthermore, it isn’t terribly responsible of family doctors to be prescribing SSRI’s to patients. That is outside of their area of expertise! (In the past), specialists in internal medicine in the U.S.A. would not prescribe SSRI’s nor anti-depressants of any sort unless it were to renew a prescription after a psychiatrist has already made a diagnosis and treatment plan that included a particular SSRI. Unfortunately, I suspect that has changed in the past five or ten years, as it has become so much more difficult for most people to get access to medical care in the U.S., let alone specialist care.
Dr. Healy, I am not quibbling with you regarding the likely harmful effects of SSRI’s taken by pregnant woman. And you are very correct, about the difficulty of stopping these medications, which many fail to realize. Anti-depressants DO save lives, but should be used only when the benefits clearly outweigh the potential negative effects. The old protocol was probably well-designed, that is, when licensed mental health physicians were the only ones to prescribe psychiatric medicines initially and others allowed to renew, but on a limited basis, and only after a psychiatric diagnosis made by someone who was qualified.
I just spent a few moments skimming the abstracts for a few of your peer reviewed journal articles, for which I thank you for providing URLs. I noticed your BMJ paper (one among many that you wrote), dated 2006, which found that Glaxo was more vigilant about issuing advisories and warnings than the regulatory agencies!
This is a messy matter that requires policy, standards and enforcement, as the situation seems to be getting worse rather than better each year.
The reason that physicians of all types, including psychiatrists, ignore the risks to the fetus is because in every article published about antidepressants and birth defects, some so-called expert psychiatrist pops up to say the health risk of the mother’s depression outweighs the risk to the neonate.
The message repeated over and over is that a poorly defined “depression,” which is so often situational or can be treated by non-drug means, is worse than a birth defect, which is permanent!
It’s drug-mongering propaganda of the worst sort: Psychiatry is committed to promoting the myth that “depression” (whatever that is) is a life-threatening illness justifying any risk of medication.
“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.”
Truer words have rarely been spoken. I would take it one step further; not only can they only do good, but they are a necessary for healthy living. The pharmaceutical industry has taken the noble concept of preventive medicine (i.e. diagnose disorders early when they are easier to treat) and utterly corrupted it to mean a lifetime of drug consumption to prevent the natural consequences of life. Think about it, they have convinced most of the scientific elite and huge swaths of the population that the induction of a pathological state within the body constitutes a healthy lifestyle. Orwell was not too far off the mark. Consider:
• Joseph Biederman and Johnson and Johnson’s absurd assertion that one can diagnose bipolar disorder in infants, leading to a lifetime of treatment with psycotropics
• Insistence that children with “attention issues” be placed on amphetamines to correct hypothesized chemical imbalances. Parental reluctance is met with threats to involve state social agencies.
• Widespread use of statins to control cholesterol when it has never been shown they actually reduce the incidence of heart disease. The NIH’s recent consideration of administering statins to healthy individuals as a preventive measure is almost beyond parody.
• Forty-eight vaccine doses by age six (per the CDC schedule) to prevent diseases that most have never heard of or haven’t seen in decades. The one-fits-all schedule applies to all children regardless of health, family autoimmune history, or socio-economic status. Those who dare question the need for so many shots are derided as irresponsible and dangerous.
• Demands that everyone receive yearly flu shots to stay “healthy” despite serious questions regarding efficacy. The independent Cochrane Collaboration has repeatedly shown the flu vaccine does little to prevent influenza. On top of that, the flu is inconvenient yet almost always harmless in otherwise healthy individuals.
• Promotion of drugs such as Rogaine and Viagra to treat conditions that are upsetting but not physically debilitating. Of course they are justified under the banner of improving one’s emotional state without any collaboration or subsequent risk/benefit analysis.
• The corruption of the DSM to medicalize and pharmaceutically treat normal conditions such as short-term depression after the death of a loved one.
The list goes on and on. Those that reject these demands and instead promote healthy lifestyle choices, nutrition, and self-discipline are derided as dangerous quacks. Now they insist pregnant women must also partake to remain healthy, despite the total inversion of the dictates of common sense. Thalidomide was just a blip on the radar screen, no lessons were learned.
Jeff, when you say “The pharmaceutical industry has taken the noble concept of preventive medicine (i.e. diagnose disorders early when they are easier to treat)…” the apparently noble concept is, in my opinion, another insidious way of increasing the market for Big Pharma. It used to be the case that people saw a physician when they were ill. Now, we are all supposed to go regularly, have “screenings” for just about everything and, guess what? If we look hard enough, we find “abnormalities” that then have to be treated. The actual epidemiology involved has shown over and over that many, if not most of us, if examined closely enough will be found to have conditions, including cancers, that never progress and cause no problem. For example, at least fifty percent have lower back herniated discs that we are completely unaware of. Blood work just outside of the “normal” range requires treatment – when the “normal range” was based on twenty year olds. It is the brave physician who, finding such things will keep quiet and do nothing because sometimes the best medicine is no medicine. If there are no rashes, fevers, lumps, bumps, pain or bleeding perhaps we should all follow my ninety-some year old grandfather’s advice for healthy living: “Take a walk every day and keep your bowels open,” which, in his case was real oatmeal porridge every day (lower cholesterol), lots of water (good hydration and no constipation- see oatmeal also) and exercise (increased cardiovascular function).
Irene – I could not agree more. I would add to your list the touchy-feely and innocuous-sounding “well-baby visit” which is actually an excuse to get the infant into the pediatrician’s office for a series of vaccinations (typically seven doses in a single visit). I suppose “multiple painful shots visit” doesn’t have as nice a ring to it.
I’m not anti-vaccine, but an assembly-line schedule that treats all infants as cookie-cutter subjects is the antithesis of medicine. Antibody titers can easily be measured to see if the baby truly needs the multiple boosters before administration yet it is almost never done. We routinely vaccinate infants against things that were considered harmless when we were children such as chicken pox. We vaccinate all infants against Hepatitis B although it is virtually unheard of in infants if the mother does not have the disease (easily confirmed via blood test). These indiscriminate methods imply the vaccination is risk-free, unlike every other invasive medical procedure known to man. Children today receive between three to four times the number of vaccine doses my generation received in the 1960’s and 1970’s. Are kids today healthier?
It doesn’t take much imagination to see who benefits from the current system.
Say we select someone randomly, any ‘normal’ person.
Put this person in front of a psychiatrist.
The person is asked searching questions for a couple of hours.
What are their fears?
What are their anxieties?
Do they get worried about things?
Do they have marital problems?
Do the kids play up?
Is money a problem?
Confronting all these issues in one powerful interview is most disturbing to the person, who may then become agitated and tearful not having realised they had so many problems to deal with.
Hmm, says the psychiatrist.
I think I have the answer. You seem to have quite a few mental health issues here, which are all listed in the psychiatrist manual of psychiatric disorders and I have some medication which will help you overcome some of the difficulties you are experiencing.
How tempting for the person to naively accept this professional advice from such a well-informed, professional who only has the person’s interests at heart.
Flattered that such interest is being taken in them and that a pill will magically deal with it all and life will become so much easier, the person will enter the world of mental stigma and their previous life of mental independence will be sucked out of them.
Ambushed, brainwashed; their previous mental strength will be invaded and a life-time of ‘sweeteners’ and interfering analysis awaits them.
Speaking of psychiatrists, would that an hour or two were actually spent in a clinical examination. I conducted a little experiment recently. I had noticed that the waiting room of one of our many local psychiatrists (more on that later) was always full to bursting. I took a seat and started timing the length of interview – some no doubt for prescription renewal or forms to be signed but the average was – seven and a half minutes. The province in which I live has 11 respirologists, 28 neurologists, 42 cardiologists and 184 psychiatrists. I plan to move as soon as I can sell my house.