My aunt B rang me a couple of months ago. She wanted to talk to me about a problem which was important to her. “I don’t want to talk to my doctor” she said, “because she does not understand.” It was about her medication. Some years ago she had been prescribed a statin, having previously been only on a beta-blocker for her blood pressure – which had been well controlled for a long time.
Having taken the statin for a while, she started feeling bad. “It is so difficult to explain,” she said, “but I felt so rotten I didn’t want to go out or do anything.” There were physical symptoms, too, but what really bothered her was the way her state of mind was affected. “I couldn’t stand it, and I stopped taking the drug without telling my doctor. I soon felt normal again, and what a relief it was. The problem now is that my new doctor insists that I should take a statin since my cholesterol is a bit higher than it should be. I can’t stand the thought of what might happen to me if I do. I will be 89 in a few months, and I am at peace with the knowledge that my life can end anytime soon. My life is still meaningful to me, but only if I can enjoy my normal simple pleasures, like going out for a stroll, or sit in the garden listening to the birds. I’d rather die tomorrow than live another day feeling like I did last time I tried that drug”.
When I asked what she wanted me to do, it was clear that she had already made her mind up; taking the drug would cause her more harm than she was prepared to accept. She just wanted to have some reassurance that she wasn’t crazy, thinking the way she did.
I told her that, in my view, her thinking was perfectly sound. She knew why the statin had been prescribed, and what the expected benefits were. She had made her own risk assessment and made a choice that was right for her, and she was prepared to take the consequences of her actions. I also said that I was prepared to take the risk, by not having protested vigorously, of being accused of colluding in a decision which might shorten her life expectancy. We both laughed at the absurdity of the whole situation.
Now don’t get me wrong. I am full of respect for practising physicians, and would not normally advise anyone to ignore their doctor’s ordinations. But there are always exceptions, and I happen to believe that this is a case in point. My aunt’s story is an important reminder that patients may not always agree with their doctor on what is best for them. There is no magic ‘one-size-fits-all’ formula for benefit and harm assessment!
The story is also an illustration of the importance of case histories for a more complete understanding of adverse reactions. How would one interpret an ICSR with ‘feeling rotten’ as the only clue to what happened`? In my aunt’s case, ‘dechallenge positive’ would not tell us much, either, of the intensity of relief and the feeling of having got one’s life back. There is clearly a danger in reducing what would be a meaningful and important message to coded bits of information that won’t give us the full picture, and which may lead to the wrong conclusions.
Having said this, should we reject a report just because it lacks sufficient detail for a thorough assessment? I don’t think so. However, for any regulatory pharmacovigilance system to be taken seriously, it should have functions in place to encourage health professionals and patients to provide the best information possible. To achieve this, trust is vital. Without trust (and empathy!) between health professionals and patients, problems in medicines use may not be reported in the first place. Secondly, those who report need to feel confident that the data they provide will be kept secure and used in a responsible way.
Data protection must be taken seriously, but not to the point where it overwhelms the protection of patients from harm. Judging from the multitude of patient groups and forums available on the internet, where detailed (but anonymised) individual data is freely discussed and exchanged, the impression is that many, many patients positively want their stories told; and that they are not worried about the information being publicly available.
Is there any evidence that patients have been improperly or criminally identified from ICSRs in the last 50 years of pharmacovigilance? If not, who are we protecting, and why?
P.S. When I talked to B today she said that she had had a good day, going for a walk, and tending her geraniums. She is happy for me to tell you her story.
Uppsala Monitoring Centre · Tel: +46 18 65 60 60 · Fax: +46 18 65 60 88