Agnus Castus: Thank you Dr Nick Panay

NAPS guidelines for GP's
NAPS guidelines for GP’s

I wrote again to Dr Nick Panay last week, Consultant Gynaecologist, Queen Charlotte’s & Chelsea and Chelsea & Westminster Hospitals. I was following up on his promise to raise the issue of why Agnus Castus was not prescribable by GP’s, at the next NAPS (National Association Premenstrual Syndrome) trustees meeting. Dr Panay has developed guidelines for GP’s on how to treat PMS, and one of his recommendations is for women to try 20mg – 40mg of Agnus Castus, if diet and exercises changes do not improve the symptoms (see above). The problem is since changes to the status of herbal remedies from food supplements to medicines, the dose of Agnus Castus can be no more than 4mg per tablet, with the recommended dose of 8mg – to understand why, see this previous blog post and this one and this one and this one.

Dear Juliet

We discussed this at our last trustees meeting.

We are in full agreement with you that Agnus Castus should be prescribable.

However, this would require registration studies and to our knowledge no company would be able/prepared to conduct these at present.

In the meantime NAPS will continue to support the recognition of this product as an effective evidence based therapy for PMS.

I have copied this email to our CEO for information.

Best wishes

Nick Panay

I was really pleased to hear Dr Panay once again endorse Agnus Castus as an effective therapy for PMS. I know this, of course. My life has been transformed by taking one 20mg tablet a day. But I felt NAPS could do more. Below is my rather impertinent reply and Dr Panay’s gracious response:

Dear Dr Panay,

Thank you for your response, although it saddens me that the NHS can’t find a way to fund the research needed, considering the savings it is likely to make if AC was offered by GP’s. I know I placed a lot of cost on the NHS with repeated GP visits, various hormonal treatments, consultant referral, scans, more treatments – I have not visited my GP for PMT symptoms in over 5 years since taking AC. Based on my blog I am not unique in this.

What I struggle to understand is why the RCT studies already conducted in Germany and China are not sufficient evidence for AC to be prescribable in the UK as it is in Germany. I know the China study was rejected by the EMA as it did not contain European participants – although the reason for this exclusion escapes me.

Could you tell me what registration studies? I assume RCT’s – but how many, on what sample size.

I also struggle to understand why a commercial company must fund them when there is new NHS research fund: Increasing research and innovation in health and social care, just being set up that academic researchers could access. Surely this would be something NAPS could consider applying to – I would certainly get involved in any way I can.

I feel strongly that NAPS could take a lead in this and with your authority engage hospital departments to trial AC as part of an RCT.

Possibly I am being naive, but your guidelines should be more than guidelines, they should be the standard by which GP’s assess and manage women coping with PMT. It would have saved me a lot of pain, side effects, time off work and NHS money if my GP had followed them (and been able to prescribe Agnus Castus).

I hope you will consider how to move this simple (if not fraught with complexity) issue forward. Agnus Castus works for many women and they should be able to get access to it. I understand that pharmaceutical companies need to make money, but health and the solutions to health concerns should not rest solely in the hands of commercial interests.

Yours faithfully,

Juliet O’Callaghan

We share your frustration Juliet.

What is required is a European study with around 100 patients, minimum of 3 months to assess symptoms and one year to assess risks and benefits; this would be the gold standard. We will see what we can do about raising funds for such a project … the funds do not necessarily need to come from the pharmaceutical industry but grant money is not easy to come by.

In the meantime, we are working with the International Society for Premenstrual Disorders and the RCOG to make our guidelines the benchmark by which all health physicians manage PMS.

We look forward to your ongoing support.

Best wishes

Nick

What a brilliant response! Dr Panay is looking into how to raise funds for registration studies. If Agnus Castus were prescribable it could pave the way for other herbal remedies, which, since the change in legislation, have been ‘downgraded’ with the dosage in most cases below effective levels.

Thank you Dr Nick Panay. If you can make this happen, then I know many, many women will benefit.

Please add a message of support and encouragement to Dr Nick Panay in the comments below. It can only help.

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Should we not end this War on Drugs?

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After reading of another death from an overdose of PMA, which, according to Harry Shapiro, of the drugs agency DrugScope:

“ has become increasingly prevalent after a crackdown on the chemicals needed to make ecstasy (MDMA)”

Should we not end this War on Drugs and make them available in the same way we do alcohol and tobacco?

“In 2011, PMA was linked to one death. In 2013 there have been 23 deaths linked to the drug.” Research by BBC Radio 4’s File on 4 programme found.

According to Professor Nutt, PMA is five to ten times stronger than MDMA (Ecstasy). The tragedy is the 23-year-old man did not die from taking ecstasy, but from taking what he thought was ecstasy. How many thousands of people took what they thought was ecstasy on New Year’s Eve? How many are taking it right now? Whether we like it or not people take drugs, be it alcohol, tobacco, ecstasy, cocaine or weed and most of these people will be back to work on Monday, drug free, except for the smokers, of course.

Comparison to alcohol is a common argument used by those who wish to legalise drugs. Most adults drink, but most adults are not alcoholics. Using alcohol is not the same as abusing alcohol. Hence the same logic can be applied to drugs. Therefore the vast majority of users will not become addicts. However, if you take smoking as the comparison ‘legal’ drug, the picture is not so clear cut. Most adults who smoke are addicts. What starts as an occasional activity soon becomes a daily habit. There are very few ‘social smokers’. If drugs are more like cigarettes then making them legal would be a disaster.

The truth is of course somewhere in the middle. Drugs are not all the same. I would not arrive at work to teach after a glass of wine, but I’ll drink three cups of coffee before first lesson. Some drugs appear to have more addictive features (cocaine and heroin) whereas others seem to be more specific to a particular occasion e.g. ecstasy and partying, and therefore less inherently addictive.

All drugs are not equal. If they were legalised there would be costs AND there would be deaths. But there are costs NOW, and there are deaths NOW. We have to accept that allowing drugs to be sold openly would create a new set of problems; health rather than criminal. The constant availability of high fat/sugar food is too much of a temptation for many people, hence the rise in obesity and associated health risks.  Many more people who may never have tried cocaine will do so increasing the amount of addicts and potential fatalities. The biggest risk will be from commercial interests. There would have to be legislation on advertising and promotion, much as there is now with tobacco and alcohol. Tax revenue from sales, and money originally spent on the war on drugs, will have to be diverted into health and support services.

I’m not suggesting legalisation is going to solve the drug problem, but it will make it easier to identify those who are at risk and enable resources to be targeted in those areas. Dying from a dodgy ecstasy tablet or being knifed in a turf war between rival drug gangs is hardly solving the problem either, and the randomness of these deaths makes them wholly unpreventable and deeply uncomfortable.

It has been argued that some of the most ground-breaking discoveries have resulted from drug altered perception, such as the structure of DNA. Equally heroin addiction makes women vulnerable to sexual exploitation and violence, and casts a tragic shadow over many families. Yet trying to eradicate drugs seems about as useful as catching rain water in a sieve. We need to be grown-up about drug use and we need to understand what turns USE to ABUSE. Rather than a war on drugs, we need to fight a battle against factors that make addiction more likely such as dysfunctional family relationships, abuse in childhood, low self-esteem and deprivation.

Just as drugs are not all the same, neither are the people who take them, and neither should be the laws that govern them. Colorado and Washington have taken a bold step in allowing the sale of cannabis to over 21’s. It will be interesting to see whether these States descend into ‘reefer madness’, or whether the extra tax revenue (estimated at 40 million) provides much needed community funds. It will also be interesting to see if other governments follow their lead or whether they will continue to engage in a war where there can be no winners.

What do you think?