There has been increasing concern that drug companies have not provided the full picture about new medicines
By Jerome Burne
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There has been increasing concern that drug companies have not provided the full picture about new medicines
Several years ago, Anne-Marie Cook, a 40-year-old health care assistant from Surrey, was prescribed the antidepressant Seroxat after she’d become anxious and withdrawn following the death of her father.
Within a few months she began to feel better
and started going out with friends again. Sensibly, she checked the drug
information leaflet to make sure it was all right to have alcohol while on the
medication. ‘There is no known interaction between Seroxat and alcohol,’ it
read.
But this isn’t the whole story, as Anne-Marie
learned to her cost. In rare cases, there is an interaction. She had no idea of
it at the time, but with hindsight it explains her changed behaviour.
‘After just a couple of drinks I started to
become verbally aggressive and reckless,’ says Anne-Marie (not her real name).
‘Once I started drinking I found it hard to stop. I also found I was becoming
confused after drinking alcohol.
‘I got banned from restaurants and bars in my
local town and became an embarrassment to my friends. Once I climbed onto my
roof. I was not trying to kill myself. I felt as if I was in a dream.’
For over a year her drinking worsened and she was even arrested several times. She lost her job and her home, but couldn’t stop herself. ‘I knew something was wrong; my craving for alcohol was so intense I felt possessed, but couldn’t understand why.’
She searched the internet for clues and, to her astonishment, found she was far from alone. Seroxat is one of a group of antidepressant drugs known as SSRIs, or selective serotonin reuptake inhibitors.
As Anne-Marie explains: ‘There were lots of
other people reporting the same desperate craving for alcohol on SSRI
medication. Yet no one in the medical profession seemed to be taking notice of
it.
‘I had tried telling my GP and doctors I saw
in rehab that I thought the drug was the cause, but they accused me of being in
denial about my alcoholism.
‘The Patient Information Leaflet (PIL) didn’t
mention it because it is a fairly rare side-effect.’
Anne-Marie’s story and how she eventually
discovered a link between the drug and her craving, is told on rxisk.org, a new
website designed to collect information about uncommon side-effects of drugs, in
order to help patients get their concerns taken seriously by their doctor.
Since it was set up last autumn, the website
has collected a number of reports about another rare SSRI side-effect — severe
hair loss.
It may sound superficial, but it can have
devastating consequences, particularly for women.
Unusual adverse reactions such as these will
not appear in a drug’s patient leaflet because they have not shown up in a
clinical trial. This is because clinical trials don’t study enough people to
pick up uncommon effects, says psychiatrist Tim Kendall, a visiting professor at
University College London.
‘Drug trials are not a good way of picking up
uncommon side-effects because the drugs are tested only on a few thousand people
and then prescribed to millions.’ But unreported uncommon side-effects are just
part of a bigger problem.
The website also acts as a forum for patients to discuss any problems they are having with drugs, such as hair loss
RxISK is the brainchild of a leading
psychiatrist, Dr David Healy of University of Wales, Bangor. Author of over 100
scientific papers, he is a long-time campaigner for greater transparency about
adverse effects of drugs.
‘Drug companies and the drug regulator have
never been proactive about uncovering evidence of risks from drugs,’ he says.
Over the past few years there has been growing
concern that drug companies haven’t provided the full picture about new
medicines.
Take the blockbuster diabetes drug Avandia —
it raises the risk of heart attacks and internal memos showed the drug
manufacturer had known about this potential side-effect since 2006. However, it
wasn’t until an independent researcher published data showing this risk in 2007
that the information was made public. The drug was finally withdrawn in the UK
in 2010. An estimated 1,200 heart attacks a year were the result of taking it.
Critics say the drug regulation system is also
to blame for lack of information about drugs, including potential side-effects.
Many widely used drugs are licensed by the
drugs watchdog on the basis of summaries of trial results. Independent
researchers have no right to see all the data.
On the few occasions when full data has been
released, it hasn’t matched claims in the summaries, says Professor Kendall,
medical director of the National Collaborating Centre for Mental Health, which
produces guidelines for NICE (National Institute for Health and Care
Excellence).
‘The agency often won’t release full details
of the results of drug trials, claiming commercial confidentiality,’ he says.
‘We need greater transparency about the safety and effectiveness of drugs. The
RxISK website is a valuable first step.’
The site makes it easy for patients to see if
their symptoms could be a side-effect of their drug.
It allows you to access more than four million side-effect reports sent to the
American drug regulator, the Food And Drug Administration, since 2004. You can
see which are considered most serious and which have been reported most often.
At the moment, if you tell your doctor that
you have been having side-effects, such as losing massive amounts of your hair,
it’s not evidence the drug caused it.
Official advice is for you or your GP to fill
in a Yellow Card, giving the details and to submit it to the Medicines and
Healthcare Products Regulatory Agency (MHRA). But the system is flawed, say
critics.
‘During my time in clinical practice it became
clear that the Yellow Card system was not a useful source of information,’ says
Sir David Weatherall, now retired and Regius Professor of Medicine Emeritus at
Oxford University.
The new website has set up an early warning
system to see if patients’ reports flag up a risk. ‘It doesn’t involve anything
elaborate,’ says Dr Healy. ‘When you report an effect on RxISK, there is a form
that includes a few questions about your experience with the drug.’
These include: Did the problem start about the
time you started on the drug? Did it start or get worse if the dose was
increased?
Once you’ve submitted the form, one of the
site’s medical team assesses how likely it is that the drug is responsible and
emails you the results so you can discuss it with your doctor.
The site’s medical team includes the previous
head of the World Health Organisation’s unit for monitoring drug side-effects
and a biomedical physicist who has developed a system for analysing adverse
medical events.
Armed with the RxISKRxisk report, you and your
doctor can have a much more informed talk about making changes, such as altering
your dosage.
If you improve as a result of lowering the
dose or stopping altogether, ‘that’s a pretty good clue the drug is linked to
the problem,’ says Dr Healy.
Sir David Weatherall feels this approach ‘is a
much better way of making use of same sort information you report on Yellow
Cards’.
The site also acts as a forum for patients to
discuss problems they’ve been having with drugs. Funding comes from selling data
to governments, health insurers and pharmaceutical firms.
Anne-Marie finally persuaded her doctor to
switch her to an antidepressant that works differently from SSRIs and her
alcohol craving vanished.
When she learned about RxISK she posted her story on the site, hoping it may help others: ‘I look to other people’s experiences for information about drugs. They seem to be more accurate and honest in their findings than companies, regulators or doctors.’