How many middle-aged men need HRT?
Prescriptions
for testosterone drugs have shot up around the world over the last
decade. But there is growing concern that they are being over-used and
may not be safe.
The adverts are selling a new disease to the public: Low Testosterone, or Low T. The syndrome even has its own website, isitlowt.com, funded by the pharmaceutical company Abbvie. Men are encouraged to take a Low T "quiz" asking them questions like "Are you sad and / or grumpy? Do you have a lack of energy? Are you falling asleep after dinner?"
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Dr Richard Quinton Consultant endocrinologist"If you are up all night, the next day your testosterone will be very low”
That might sound like every
middle aged man you know, but if the visitors to the site answer with
too many yeses, they are nudged towards having a chat with their doctor.
In the US, where direct marketing of prescription drugs is permitted
("Ask your doctor about our new product!") the drugs themselves are
promoted too. They vary from pills and injections to gels.
Doctors agree that a small proportion of men - about 0.5% - need testosterone therapy. These include men born with genetic diseases or whose testes no longer function after chemotherapy. It was for cases like these that the US Food and Drug Administration (FDA) sanctioned the sale of the drugs.
But those aren't the only men with low testosterone levels, and it's thought that the rapid increase in testosterone prescriptions, especially for handy roll-on gels, is going to a wider group of men many of whom have no such conditions.
A man's testosterone levels tend to drop steadily after the age of 40, and can fluctuate from one day to the next.
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"Disease awareness ads are becoming the preferred form of advertising for drug companies. No brand names are mentioned in the ads, but they sometimes adopt the same colours as commercially available products," writes Lisa Schwartz.
"For drug companies, they have a number of benefits. They can place them where direct-to-consumer ads are not allowed, such as in Canada and South America. They don't need to mention any side-effects of taking drugs. And the public sees them as less of a hard-sell than an advertisement for a commercial product.
"But they can be very confusing. It's unclear if they're public health messages or if they're marketing. They sort of blur that line.
"Disease awareness campaigns can serve the public. But not when they exaggerate the danger of disease or the benefit of treatment."
An ill for every pill
"Disease awareness ads are becoming the preferred form of advertising for drug companies. No brand names are mentioned in the ads, but they sometimes adopt the same colours as commercially available products," writes Lisa Schwartz.
"For drug companies, they have a number of benefits. They can place them where direct-to-consumer ads are not allowed, such as in Canada and South America. They don't need to mention any side-effects of taking drugs. And the public sees them as less of a hard-sell than an advertisement for a commercial product.
"But they can be very confusing. It's unclear if they're public health messages or if they're marketing. They sort of blur that line.
"Disease awareness campaigns can serve the public. But not when they exaggerate the danger of disease or the benefit of treatment."
"At any time in life, your
testosterone drops if you're ill for any reason," explains Dr Richard
Quinton, a consultant endocrinologist at Royal Victoria Infirmary in
Newcastle, England. "And I mean for any reason. If you are up
all night, the next day your testosterone will be very low. You have a
big meal - that can affect your testosterone level. Any kind of
underlying disease can lower your level."
Schwartz says there is little scientific evidence that the drugs fix men's lives in the way the adverts demonstrate. "All the testosterone drugs have been approved on the basis that they raise testosterone level - not on the basis that they make anybody's life better," she says.
Part of the appeal of the drugs is they feel like a quick fix to complex - and common - life problems, Schwartz believes. She describes one patient who came to her on a course of testosterone treatment "but he had these waxing and waning symptoms and I was unconvinced that it had anything to do with it". She took the patient off the drugs and he was diagnosed with depression. "He really benefited from therapy," she says.
For its part, Abbvie has defended the way it markets its drugs, and says its awareness campaign for Low T is designed "to educate men about hypogonadism to encourage dialogue with their physician".
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Dr Hugh Jones Professor of Andrology"If you pick the right patient and treat them appropriately... you can change someone's life around”
Many physicians are evidently
only too happy to prescribe the drugs. There are also doctors who, while
sceptical about the way testosterone is being prescribed, don't share
Schwartz's doubts about its ability to make men feel better - and there
are positive testimonials from patients, too.
But when he turned 60, he found his energy levels dropped dramatically. "My body was just like I had run a marathon," he recalls. His sexual desire and all romantic feelings "went out the window" - even the desire to kiss or hold hands. He was with a partner at the time, and Bill's sudden change of mood affected their sex life.
He went to his doctor, who prescribed a testosterone gel that he rubbed into his shoulders. Bill's been using the treatment for four years and now, he says, he feels fantastic.
Bill says that testosterone treatment has given him back his life
Jones has worked on a number of studies, with some funding from drug companies, that examine how testosterone may improve mortality. He was one of the authors of a study published last year which showed that men with type 2 diabetes had a higher mortality rate if they had lower testosterone levels, and that the risk of mortality dropped if men were given testosterone treatment.
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Find out more
Richard Quinton and Hugh Jones spoke to the Science Hour on the BBC World Service
"Although this was a
retrospective study it's one of two studies which has shown that by
giving testosterone back it improves survival," he says, although he
adds that the treatment is "a mixed bag" that doesn't benefit all men.
"I think that Hugh Jones has done some fantastic, ground-breaking studies," says Quinton. "However, he needs to do bigger ones."
He is worried doctors are about to repeat the "disaster" of hormone replacement therapy (HRT) in women. After observational studies suggested that HRT had a range of positive effects on
post-menopausal women - raising sex drive and lowering cholesterol and the risk of heart disease - it was heavily promoted by doctors. Then a randomised control trial was completed which found that HRT increased the risk of breast cancer, heart attacks and strokes.
"It went from being hugely pushed - 'Take this, it's good for you' - to - 'It's poison, it gives you breast cancer, stop!'" he recalls. "It's a rule of thumb for most hormone treatments that they work really well if you're using them to treat someone who's deficient in them. But if you start treating people with other problems then generally they don't - they pop up with adverse effects."
Doctors' attitudes to women's HRT have changed
A study published in November in the Journal of the American Medical Association looked at the medical histories of 8,700 US veterans, many with underlying heart problems, and all with apparently low testosterone levels. The men in this group who had been put on testosterone had a 30% higher risk of stroke, heart attack and death. A second study, published in January on PLOS One, looked at the medical records of 55,000 men who had been prescribed testosterone.
It found that men over the age of 65 doubled their risk of heart attack in the 90 days after being given their prescription.
"A high level of testosterone will drive your red blood cell count up, which is the reason why professional athletes abuse it, because it increases their oxygen carrying capacity," says Quinton.
"However, that also makes the blood stickier or more viscous and that may then predispose someone to heart attack or stroke-like events."
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Last week, Miriam Gonzalez Durantez (wife of the UK's deputy prime minister Nick Clegg) said: "taking care of your own children and being responsible for your children does not affect your level of testosterone"
However, Richard Quinton says there is some evidence to suggest that men who care for children have lower levels of testosterone
He assumes that Gonzalez Durantez was "speaking figuratively"
Childcare and testosterone
Last week, Miriam Gonzalez Durantez (wife of the UK's deputy prime minister Nick Clegg) said: "taking care of your own children and being responsible for your children does not affect your level of testosterone"
However, Richard Quinton says there is some evidence to suggest that men who care for children have lower levels of testosterone
He assumes that Gonzalez Durantez was "speaking figuratively"
Yet both pieces of research have
been criticised, since there is no indication that the men in the
samples had been monitored to check their testosterone levels weren't
overshooting the target, or even that they had been diagnosed properly
in the first place. Before being prescribed testosterone, patients
should have a baseline measurement taken on an empty stomach in the
morning. But research published last year found that a quarter of men in
a very large US sample hadn't been tested at all before being
prescribed the drugs.
Notwithstanding the recent studies' shortcomings, in January the FDA issued a safety announcement reiterating that testosterone drugs should only be prescribed to men with low testosterone associated with a medical problem, i.e. one that prevents the testes producing testosterone. A number of men have now filed law suits against Abbvie, claiming that the company did not warn them they risked heart attacks by using their drugs.
For Hugh Jones, testosterone therapy is not risky so long as doctors properly diagnose and monitor treatment. "If you pick the right patient and treat them appropriately with that diagnosis, you can change someone's life around," he says.
Although there is no conclusive evidence that the drugs are harmful, Richard Quinton says the results of different trials are starting to "triangulate" and frail, older men should avoid them.
"Testosterone is not the elixir of life. It's a great treatment for men with true testosterone deficiency but it's not a life-extending drug for those who aren't properly deficient."
Listen to the report on testosterone on The Science Hour on the BBC World Service. Listen to the programme on iPlayer or get the Science Hour podcast.
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