The first time I meet breast surgeon Julie Doughty, in Starbucks at the San Antonio Convention Center in Texas, she is bursting with passion – and anger.
We are here for a major cancer conference and I’m hoping Doughty, a highly respected consultant in Glasgow, will give me a few tips on the hot topics.
But she has other ideas. ‘I’ll tell you what you need to write about,’ she says, clearly fired up. ‘The fact that countless women tell me, “The life I have on tamoxifen is awful.” ’ Tamoxifen is a daily pill taken by about 550,000 British breast cancer survivors. It can slash their risk of recurrence after treatment by up to 45 per cent.
It’s also offered to women with a strong family history of the disease, as it cuts their odds of ever developing it. At about 6p per pill, it has been hailed a ‘wonder drug’ – widely said to cause few side effects in the majority of patients. Surely good news, then?
Tamoxifen is a daily pill taken by about 550,000 British breast cancer survivors (stock image)
Doughty couldn’t disagree more. ‘I object to the suggestion that the drug has “little toxicity” and is “well tolerated”,’ she says.
‘I see women who are struggling on tamoxifen and other hormone drugs on a weekly basis. The worst symptoms by far are the hot flushes and sweats, but many women suffer from joint pain and feel very depressed. That’s the real story.’
To say the medical community is divided over tamoxifen, and its downsides, would be a huge understatement. Last week, a Leeds University study found that four in five women at high risk of breast cancer, when offered the drug for prevention, didn’t want it.
More than half reported concerns about potential unpleasant side effects.
Yet lead researcher Dr Samuel Smith appeared to think the real problem was one of perception. ‘Some beliefs were very negative,’ he said. ‘This appears to be putting some women off tamoxifen, despite its proven ability to help prevent breast cancer.’
Professor Jack Cuzick, at Queen Mary University, London, who led pivotal trials into tamoxifen, wants more women to try it.
‘It’s become demonised,’ he says. ‘The fear that everyone is going to have these terrible side effects is a gross overstatement. We are trying to help women, not make life worse for them. Tamoxifen has been given a bad name, unfairly.’
But many patients clearly loathe being on the drug. At least half of breast cancer survivors are thought to stop taking it before the recommended five years. And many more – aware of this – are unwilling to take the tablets in the first place.
It is hard not to notice that female medics seem more in tune with this than many male researchers. So is there, as some have privately suggested to me, a sex divide among doctors on the issue? And more importantly, where does this all leave patients?
Mary Huckle, who has taken Tamoxifen as part of her breast cancer treatment
Mary doesn’t regret stopping it – even though cancer returned
Mary Huckle, 53, a personal trainer and mother- of-three from Enfield, North London, was diagnosed in August 2007 with an aggressive form of breast cancer.
She says: ‘I have small breasts and the lump was found behind my nipple, so I had no choice but to have a mastectomy.
‘After six months of chemo, I started taking tamoxifen in 2008. I was on it for five years. My decision to come off it was made when it was suggested it would be even better to take it for ten years.
‘The side effects were unbearable. I woke up every morning with a foggy head and awful headache.
‘There was joint pain in the wrist and knees. Then I started getting back pain too.
‘I used to be a Pilates teacher – I know how to look after my body and this wasn’t normal for me.
‘When I stopped taking the drug, the headaches and brain fog went immediately.
‘As the drug was still in my system, it took a while for the joint pain to go. I’ve got secondary cancer now and take an oral chemo drug and a hormone inhibitor – but not tamoxifen.
‘The second cancer was diagnosed around the same time I stopped tamoxifen.
‘My oncologist supported me in that decision and said it was a coincidence. Although the drug reduces the risk of recurrence, it doesn’t eliminate it.
‘Even today, I have no regrets about stopping it.
‘I understand why so many women come off it. My quality of life is so much better. As soon as I ditched tamoxifen, I got “me” back.’
ONLINE FORUMS AWASH WITH STORIES OF WOMEN STRUGGLING
Tamoxifen, which blocks the activity of the female sex hormone oestrogen in the body, started life in 1962 as a contraceptive pill.
Then, in the 1980s, trials showed that when given to breast cancer patients after surgery and other treatments such as chemotherapy and radiotherapy, it further reduced the risk of the disease coming back. By stopping oestrogen from reaching the cancer cells, it meant tumours grew more slowly or ceased growing altogether.
Today, it is one of the most taken drugs to treat the disease, and is recommended by prescribing watchdog the National Institute for Health and Care Excellence for about 80 per cent of breast cancer patients.
And, after further studies found that it reduced the chances of breast cancer developing in the first place, in 2013 it became the first drug to be prescribed to prevent cancer.
It is estimated that up to 500,000 women could benefit, but online forums are awash with breast cancer survivors who are struggling against the side effects.
Many talk about how they stopped taking tamoxifen for a ‘holiday’ and their symptoms melted away. They also complain about how doctors often trivialise or dismiss symptoms experienced by women on tamoxifen.
Tamoxifen can slash their risk of recurrence after treatment by up to 45 per cent
One woman, on Breast Cancer Care’s forum, writes: ‘I have been taking tamoxifen for about six months. I am restless, anxious, moody and the hot flushes are unbearable.
‘I’m just not sure that I am gonna be able to conquer this but am so worried about stopping the treatment. I am so miserable.’
Another, on the Cancer Research UK forum, states: ‘I have hot flushes, but compared to the joint pain, coping with those is a walk in the park.’
However, there are more reassuring comments: ‘For the first few months the sweating was horrendous, but I had my dose adjusted as I found I could handle 10mg twice a day but not 20mg once a day.’
Karen Bates, 55, was prescribed tamoxifen in 2015, after being diagnosed with cancer in her left breast. The author, from Lincolnshire, who had surgery to remove her breast along with chemotherapy and other drugs, said: ‘It made me feel like I was 90. I ached everywhere – it was as though I had arthritis.
‘I was worn out, tired, snappy. My libido had gone too.
‘A year after starting it, I stopped taking it for a month. I was about to have my breast reconstructed and tamoxifen is a blood thinner.
‘I got “me” back during that time, so I discussed tamoxifen with my oncologist, who told me that taking it meant I had only a two per cent chance of the cancer returning.
‘So I decided not to take it any more. He wasn’t happy but understood my reasoning. The cancer might come back – who knows?’
So is tamoxifen always to blame for such terrible symptoms?
Last year, Cuzick and his team at Queen Mary University published the latest in a number of studies that suggest not. For five years, they followed thousands of healthy women taking tamoxifen for cancer prevention. Half were given the real drug daily and the other half a placebo or dummy pill, containing no active drug.
They found that just as many women – about a third – taking the dummy treatment suffered severe side effects and dropped out of the trial, as those on the real thing.
‘This would suggest it’s not the tamoxifen causing the problems. It’s only natural when we have aches and pains to blame it on something,’ explains Cuzick.
‘But the truth is, these things are just part of life as we get older.’
Try telling that to Liz O’Riordan, consultant breast surgeon at Ipswich Hospital NHS Trust, who has twice had breast cancer herself, and you’ll be cut a short shrift.
She says: ‘I hated taking it. It’s a horrible drug. If there was anything else, I would have stopped it, but there isn’t. It’s the best we have at the moment.’
O’Riordan, 43, who has written a bestselling book, The Complete Guide To Breast Cancer, adds: ‘With normal menopause, the symptoms come on gradually.
Karen Bates ditched the pill due to the negative symptoms
‘But on tamoxifen, it’s “bang” – hot flushes, night sweats, insomnia, hair thinning – you can’t have sex because of vaginal dryness, and you lose your libido.
‘I know women who have begged their husbands to divorce them because they feel so bad about what they’re putting them through.’
Doughty was just as forthright. ‘Any doctor, male or female, who actually sees patients will know that women really struggle with tamoxifen. The side effects are very real.’
SO IS THE MEDICAL RESEARCH SEXIST?
There is a long-standing problem with sex bias in medical research – although few doctors will say much on the subject. Dr Clare Gerada, a GP based in London and former chair of the Royal College of GPs, says: ‘There has been a cautious, even paternalistic, medical approach to women for many years. Think back to Victorian times when women were treated for hysteria when they had physical illnesses.’
Scientific studies themselves may be relying on assumptions made in the past that contained a gender bias, such as underestimating heart attack fatalities in women, because they have subtle ‘silent’ symptoms which are often missed.
It is recognised that the lack of studies of women and how they respond to medications, which may be different to men, in cardiac medicine means mortality rates from heart disease are higher in older women than in men, for instance.
Gerada says ‘The legacy of gender bias in medical research is only just beginning to be understood, but it may cause incorrect conclusions to be drawn today.’
O’Riordan believes part of the problem is that women aren’t being completely honest with their doctors. She says: ‘Women often under-report side effects, thinking they just have to put up with them. About half of women stop tamoxifen treatment early, but pretend to their doctor they are taking it because they feel so guilty.
‘And some male doctors may well think, “How bad can a few hot flushes be?” So they don’t appreciate how debilitating the side effects are. Maybe they don’t think a pill can make you feel that bad.’
And what of the idea that the symptoms aren’t really side effects at all? ‘That’s just rubbish,’ she says.
FOCUS ON personal ‘risk assessmentS’
So what should women, fairly concerned about the downsides of taking tamoxifen, do?
Doughty believes there needs to be a more personalised approach to prescribing.
She says: ‘I’m not telling breast cancer patients, “Stop taking medication.” But it’s so important for each woman to be given a really accurate risk of her cancer coming back based on the stage and type of cancer she has, her age and other risk factors.
‘Some women may feel that they are prepared to cope with side effects if it maximises their chances of seeing their children grow up, for example.
‘But if she is really struggling on tamoxifen, and the risk of her cancer returning is very low – say ten per cent over a ten-year period – the decision may be taken between her and her oncologist to stop it. However, if the risk is 40 per cent, she may well want to persevere.’
O’Riordan agrees. She says: ‘We have very good ways to assess individual risk, using computer scoring models. A woman who has a very small cancer that hasn’t spread may already have a 90 per cent chance of being alive a decade later after surgery and radiotherapy alone. So the benefit of tamoxifen will be small.
‘If the tumour is large, if it has spread, and the patient is having chemo, the benefit of the drug might be greater. Those patients might want to consider trying it for six months to a year, to see how they get on.’
And what about healthy women offered it for prevention?
‘You’re asking a healthy young woman to take a drug that will make them feel utterly awful, that could turn them into a sexless, menopausal woman, suffering weight gain, thinning hair, leg cramps and everything else.
‘It increases the risk of cataracts, blood clots, strokes and endometrial cancer which, if you’re taking it to prevent breast cancer coming back, may be worth the risk. But even women who have had breast cancer don’t want to take it.’
Cuzick, however, feels that women should give it go. He says: ‘Some women – about 20 per cent – will have a very difficult time, and they should stop if they want to.
‘But in most cases, problems are mild. There’s also evidence that in breast cancer patients, these side effects show that the drug is working well.
‘Scare stories about side effects shouldn’t stop women at risk of breast cancer trying it, to see how they do on it. It doesn’t mean they’re committed to taking it for ever.
‘And for those who have had breast cancer and are taking it to stop it coming back, there is a case for putting up with the downsides for five years, as the benefits make it worth it.’
As for those on the drug suffering the side effects, Cuzick says: ‘Many of the aches and pains associated with getting older can be alleviated by more physical exercise. This is true whether you are taking tamoxifen or not.
‘For some women, this could mean going to the gym and doing a workout. And for others, it could be as simple as walking more.’
Additional reporting: Thea Jourdan and Samantha Brick