Dear European Medicines Agency,
Imagine, for a moment, a drug that could cure Premenstrual Syndrome (PMS/PMT), which has minimal reported side effects, and is easy and cheap to produce. What a wonderful drug that would be. A drug that could give a woman her life back after years of excruciating cramps, which even morphine was unable to control. Imagine what it would be like for that woman not to live in dread each month, and even get to the point where she forgets she is about to have a period. Imagine how much money could be saved because that woman no longer needs a hysterectomy and then years of HRT (with its increased risk of womb, ovarian and breast cancer). Imagine how many lives that drug would save if women did not have to have a general anaesthetic, nor the risk of post-operative infection.
If only a drug like that existed, instead of the current treatments on offer such as Prozac, with its increased risk of suicidal thoughts, or drugs like Danazol, which can deepen the voice and stimulate facial hair growth along with many other horrific side effects. Or, taking oral contraceptives, which stop ovulation, and with it, the natural rise and fall of libido, while increasing the risk of blood clots, acne and fluid retention.
If only a herbal remedy existed with hundreds of years of safe usage, and clinical trials proving its effectiveness, like this one reported in the British medical Journal in 2001, and this one reported in the American Journal of science in 2012, and this one also conducted in 2012 at Hamedan University of Medical Sciences, Iran. And this list of studies on google scholar, citing highly significant results compared with placebos. If only there were a study that the EMA agreed met the criteria, something like this:
“There is one publication proving efficacy for the indication “Premenstrual syndrome” for an extract
specified as follows: Vitex agnus-castus L. dry extract (6-12:1), extraction solvent: 60% ethanol
(m/m) / 20 mg per day corresponding to 180 mg drug per day on average. This preparation fulfils the
requirements for WEU.” European Medicines Agency Assessment report on Agnus Castus.
What would you do EMA, if you had all this research, alongside hundreds of women’s anecdotal accounts and clinicians testimonials?
Would you force manufacturers to reduce the dosage per tablet from 20mg (the known effective level a cited in your own report) to 4mg per tablet? But not tell women that at this dosage, the drug will be ineffective?
That would be madness, wouldn’t it? Why would you render a drug, as clearly effective as Agnus Castus, ineffective, by restricting dosage, making the treatment unaffordable for thousands of women, even if they did know to take 5 TABLETS A DAY(costing around £20 a week).
Who would this benefit? The women with PMT? The doctors who are treating these women, with the limited and often dangerous chemical or surgical solutions on offer?
No. A move such as this could only benefit the multi-million pound drugs industry, whom bring new drugs to the market with a short history of efficacy and lack of data on the long term side effects.
Restricting dosage on not just Agnus Castus, but a whole host of herbal treatments, such as St John’s Wort, is a conspiracy to keep the drug companies in huge profit and the public captive to their demands.
If you buy your tablets from Boots and take (the recommended) 4mg of Agnus Castus a day for PMS, it won’t work, your symptoms will not improve (your own report shows this to be the case). For women who buy these tablets and find no relief, they will believe the drug is ineffective and return to their gynaecologist begging them to take out their ovaries and womb (a huge decision, with huge repercussions). And gynaecologists, despite knowing how effective Agnus Castus 20mg is, will be unable to tell you about it, because it is not listed in their prescribing manual.
Because there are no profits to be made on a drug that already exists, is not concocted in a lab. No concoction. No patent. No profit.
“The pharmaceutical industry is in crisis because companies are rewarded for developing new drugs that have few clinical advantages over existing ones, experts say. They pointed to independent reviews that found between 85 and 90 per cent of all new drugs developed over the past 50 years have provided few benefits and considerable harms.” Read more here.
Forgive me if I sound a little paranoid with my conspiracy theory, but what else am I supposed to think? Either you recommend the drug or you don’t. Recommending it, as your reports final conclusion does:
“Except for severe allergic reactions, there are no documented severe adverse events. Therefore the
use of the above mentioned extracts – in combination with an adequate labelling as included in the
monograph- can be supported.” EMA report on Agnus Castus.
but rendering it ineffective, by only allowing it to be sold in a dose too low to work, smacks of underhand tactics.
If you have an honourable reason, then I for one would love to hear it. In the meantime, I will continue to tell every doctor I meet and every women with PMS, how Agnus Castus gave me my life back, and I will unashamedly plug this Guernsey based company, that can sell you 20mg tablets, despite your mean and sinister directive.
Any woman reading this, who has PMS, check the evidence out for yourself. Be empowered! Take control of your body. For the most common type of PMS, I have yet to find a woman this has not transformed the life of. However, you must take 20mg (dried fruit extract) a day.
Just think… no more mood swings, breast tenderness, irritable bowel, and no more pain so bad, you vomit and lose control of your bowels at the same time. No more lost days, lost months, lost sleep, lost life.
And my final message to the EMA – you should be ashamed of yourselves, condemning women to unnecessary medical interventions and possibly even death; very, very ashamed.
Juliet O’Callaghan – free of PMT for five years since taking Agnus Castus 20mg (dried fruit extract) once a day.
Anyone else found the EMA’s interference in herbal medicines has been detrimental to their health and pocket? Angus Castus: Has it worked for you to? Tell me your story. I would love to hear it.