Tag Archives: Prozac

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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AGNUS CASTUS – a cure for PMS, and why you won’t be able to get hold of it in Boots: An open letter to the European Medicines Agency

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.

Imagine how that woman feels to be in control of her life once more.  

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.   

Just imagine…

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.

Why?

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.

Yours ungratefully,

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.