Agnus Castus, Prozac and Sarafem: Corporate deception by any other name would be called bare-faced lying

Watching that advert, you would think that Eli Lilly had discovered a brand new drug to treat the more distressing symptoms of PMT.

You would be wrong. SARAFEM is in fact PROZAC (fluoxetine hydrochloride), renamed and repackaged to appeal to a new market of users in the US – women suffering from PMT (also repackaged as Pre-Menstrual Dysmorphic Disorder , which gives it a status as an illness and therefore can be targeted by drug companies).

“To return to the history of PMDD, some feminist professionals, including the APA’s Committee on Women and the National Coalition for Women’s Mental Health, objected to the inclusion of such a syndrome under any label. From their point of view, menstruation is a normal bodily function, and any psychological changes associated with this function should be seen as normal as well. Classifying PMS or PMDD as a mental disorder stigmatizes women, and may have other undesirable social consequences by laying additional foundations for disability claims and the insanity defense.” Click here for source.

 All Eli Lilly did was run a trial on PROZAC with women suffering from PMT. Based on this trial, where they found 60% of women reported a reduction in some symptoms, they were able to gain FDA approval for SARAFEM (Prozac put inside pink and lilac capsules).

The fact that trials on Agnus Castus (with minimal if no side effects) reports an 80% reduction in most symptoms of PMT is neither here nor there. Herbal stockists do not have the marketing budgets available to them that profit hungry Pharma companies do. And of course since 2011, in Europe at least, the dosage of Agnus Castus is restricted to 4mg per tablet, rendering them ineffective if taken as directed on the bottle.

20mg is needed to gain relief, supported by a number of trials, all of which were rejected by the European Medicines Agency – and you have to ask yourself why?  Look up Schellenberg 2001 and 2011 for trials – or see previous blog posts on agnus castus.

But why did Eli Lilly do this? Funnily enough in 2000 the patent on PROZAC was coming to an end. FDA approval of SARAFEM specifically for the treatment of PMDD, meant the patent could be extended until 2007. Eli Lilly also sold the rights to Sarafem for £187 million to NI drug company Galen in 2002, they also made profits in excess of £300 million in the first year of Sarafem’s launch in 2001.

Galen Holdings Plc, Northern Ireland’s largest drugmaker, will pay $295 million for Eli Lilly & Co.’s Sarafem, a treatment for a severe form of premenstrual syndrome…  Although cheap copycat versions of Prozac are available, Sarafem is protected from generics until 2007, King said in an interview. Sarafem is prescribed by gynecologists, who are less likely to use generic Prozac instead, analysts said. “Generic erosion, which is illegal, is thought to be modest, and underlying prescriptions are growing,” Merrill Lynch analyst James Culverwell said in a note to clients. “Sarafem fits well with Galen, as over half of Sarafem prescriptions are made by obstetrician-gynecologists, where Galen has a specialist sales force.” click here for source.

Now all Eli Lilly had to do was to convince women that firstly they were suffering from PMDD and secondly that the only cure was SARAFEM. It didn’t really matter if doctors knew the truth or not because if a patient asked for SARAFEM, doctors (in the US) could not prescribe a cheaper generic fluoxetine tablet because only SARAFEM had been specifically trialled on women with PMT. No other SSRI (the class of antidepressants prozac belongs to) had been tested specifically for PMT and therefore could not be substituted for the expensive patented SARAFEM – which don’t forget it is actually PROZAC which is actually FLUOXETINE HYDROCHLORIDE.

Drug trials (RCT’s) were supposed to be used to test out new drugs, in order to make sure they were safe and did not have dangerous side effects. Instead their use is corrupted, with pharma companies not compelled (by law or conscience) to release the results of trials conducted, meaning they can cherry pick the ones that support their commercial aims. 

The fact that the link between PMT and depression and depression and Serotonin levels is little understood should also be of no surprise. The theory goes that depression is a result of low levels of the neurotransmitter SEROTONIN, which is how messages pass between neurons (in the brain). Of course, it could equally be that feeling depressed results in low levels of SEROTONIN. It could also be the case that SEROTONIN levels in the depressed are no lower than those not reporting depression. In the case of PMT, there is the added fiction (presented as fact) that fluctuating hormone levels impact on the levels of SEROTONIN in the brain in the second part of the cycle.

None of this theory is proven and in fact the role of neurotransmitters in bodily functions, feelings and emotions is turning out to be an extremely complex picture of interrelated dependence, with neurotransmitters having a variety of roles based on where they are in the body and whether they are excitatory or inhibitory.

 “Sarafem® is an FDA-approved prescription treatment that relieves both the mood and physical symptoms of PMDD (Premenstrual Dysphoric Disorder). Many physicians believe that Sarafem helps to correct the imbalance of serotonin that could contribute to PMDD.”  Click here for source.

Note the official information above states that ‘many physicians BELIEVE that Sarafem helps…’  Even Eli Lilly daren’t claim to know there is a link between hormones, serotonin and PMT – and yet they are prepared to give out a drug to many, many women with distressing side effects, such as loss of libido and suicidal thoughts.

So there we have it. And it is not just PMT sufferers that has become a target group for money hungry pharma company boards. We have a proliferation of behaviours now classified as mental illnesses. Childhood tantrums are now called ‘Conduct disorders’. Concentration problems are labelled ‘Attention Deficit Disorder’ and if the child is also very active and doesn’t need much sleep, we can add an ‘H’ for Hyperactivity. Being shy, is called ‘Social Phobia’ and worrying about the state of a world run by capitalist corporations who serve the top 1% is called ‘Generalised Anxiety Disorder’.

And for each of these ‘disorders’ there is a corresponding drug, which messes with a delicate system we actually know very little about. And don’t get me started on halitosis, a completely made up condition to sell mouthwash. And ‘panty liners’!!! WTF! Women have secretions, they are normal, that is what knickers are for!

It is time we women said enough! We been having periods long before big pharma companies decided they were an illness.

PMT is not an illness, but some side effects of menstruation (like irritability and cramps) can make life very difficult for some women. This is no different to how it was for women hundreds of years ago. The difference was those women didn’t have pharmaceutical companies convincing them they were ill and suffering PMDD and needed this particular drug to cure them.

Instead they listened to each other and tried out remedies handed down over the generations until they found something that worked for them.

The answer to our ills doesn’t necessarily reside in a bottle of pills, but in talking to each other and not believing everything we are sold.

For more on psychiatric labels and the drug industry, James Davies has written a book called ‘Cracked: why the psychiatry is doing more harm than good’. Published by Icon 2013. 

Why is psychiatry such big business? Why are so many psychiatric drugs prescribed – 47 million antidepressant prescriptions in the UK alone last year – and why, without solid scientific justification, has the number of mental disorders risen from 106 in 1952 to 374 today? The everyday sufferings and setbacks of life are now ‘medicalised’ into illnesses that require treatment – usually with highly profitable drugs. Psychological therapist James Davies uses his insider knowledge to illustrate for a general readership how psychiatry has put riches and medical status above patients’ well-being. 

 Do you have any further examples of drugs that have been re-branded as a cure for something else? Have you tried Prozac for PMT and did it work for you? What side-effects did you have if any? 

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4 thoughts on “Agnus Castus, Prozac and Sarafem: Corporate deception by any other name would be called bare-faced lying”

  1. Good points well made, Juliet.
    Did you see Will Self’s article in the Guardian at the weekend?
    I also liked Justin Joffe’s letter in The Psychologist last month about the brave explorers going out into the world to chart new diagnoses for big Pharma.
    (I’ve posted the links along with the link to your blog on my Facebook page https://www.facebook.com/Annecdotist.)

  2. I will check out both articles. I have the Psychologist at home, but not got round to reading it yet. The more I delve into the murky world of prescribing the more I am appalled by what I find. I watched an interesting film the other night called ‘Side Effects’, which very much illustrates how the pharma companies recruit doctors onto ‘trials’ with incentives.

  3. Dear Juliet,
    Thank you so much for writing about alternative solutions for pmmd. I have had it since i was 12 and am now 40. After having a child 2 years ago my pmdd was out of control which went out onto my man( surprise) .. Poor guy.
    Anyways long story short after trying everything including a 8 months stint with the best TCM doctor in town i had to buckle and go on anti deps.
    They pharma co herr renamed cipralex and they call it premalex ( Lundbeck pharma) it costs at least twice the amount at around 40 pounds for a month subscribiton. So thats all they did..renamed it and jacked up the price by 50%.

    These pills have helped alot I only wish i had taken them sooner for my own helath and the families:-(

    You take them for 14 days and for most of us who take them they work within 30 min. I have taken them for 5 months two weeks on and two weeks off. Lately I have taken them for 3 weeks two months in a row since i really only have one good week a month. I definately felt a slight withdrawel from them this time. Yesterday I was 13 days pre period when the pms monster reared its ugly head and after two epsisode of no tolernace for my two year old i popped my pill and was back to being the patient loving mommy she deserves. The only side effects i get from them is i now sleep like a rock at night, i am a bit more fatigued. I have. Not had a libido in a while so i cant tell how much its influenced and i have really been really fatigued during my monthly cycle for a long time. On the plus side i am not as irritable, i am more functional and i dont have craving like i did pre meds.

    I have a wonderful doctor who suggested i went gluten free and caffiene free. And i have noticed a difference also with that. I realize i am one who doesnt tolerate caffeine what so ever, pity i have been addicted to dark chocolate for years.
    I met another doctor who also suggested that i try taking agnus castus in tincture form so i started that also yesterday… All i can say is wow this stuff powerful. I feel a slight hyperactivity on it, but it great spirits. Is that normal?

    Best wishes!
    Anne

    1. Hi Anne, so pleased you have come by to share your story and that you have found this blog useful. I don’t know if AC makes you hyperactive, but it maybe that the imbalance of hormones is improving and therefore the fatigue is lifting (normal may feel hyper to you).

      It sounds like you are taking charge of your PMT and that is the key to managing it better. Good luck with the ongoing treatments and do come back and let us know how you are in a few months time. You may find you can reduce the antiD’s if AC works, but obviously only do this with your doctor’s advice.

      I just wish AC was offered routinely to all women with PMT – it is always worth trying, even if ultimately other options need to be explored as well.

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