The Wall Street Journal (WSJ) reported this week on a luncheon meeting sponsored by Project ALS*, where Dr Orli Etingin, vice chairman of medicine at New York Presbyterian Hospital, and founder director of the Iris Cantor Women's Health Center, also in New York, spoke about the effect of a statin, Lipitor, made by Pfizer Inc, on some female patients.
Etingen described the effect in one patient in particular, a woman in her 40s who was unable to concentrate or remember words. They ran tests and found nothing, but when she stopped taking Lipitor, her symptoms disappeared, and when she started it again, they came back.
"This drug makes women stupid," said Etingen, who claimed having seen these symptoms in about dozen female patients.
According to the WSJ, Pfizer said that Lipitor had been tested in 400 trials and has a track record of safe and effective use in over 145 million patient years, none of which shows a causal link between the drug and memory loss. The company added that the evidence comes from a variety of sources and not from "anecdotal inferences by individual providers with a limited data pool".
Many scientists would agree, saying that anectodotal evidence is not a basis on which to do risk-benefit assessments for deciding treatment options. The nature of anecdotes is that they are selective, become "embellished" in the telling, and they don't take into account extenuating factors. However, they have a strong emotional and political effect, they have more appeal because they are highly personal stories that people identify with, and when they gather pace, they can undermine patient confidence in a drug.
Perhaps for this reason, a new study will be welcomed by all sides. And such a study is about to complete. Researchers at the University of California at San Diego UCSD) are coming to the end of a randomized controlled trial on the effect of statins on behaviour, mood, thinking skills, and quality of life.
However, what is interesting about this study is that the researchers are also carrying out a separate investigation of anecdotal, first hand, accounts from thousands of patients who have reported good and bad experiences with statins.
Beatrice Golomb, lead researcher on the UCSD study, told the WSJ they had received some "compelling cases" and related the story of Jane Brunzie, a 69 year old woman from San Diego who at first thought she had Alzheimer's because her memory skills got so bad. She said within 8 days of stopping her statin medication she was "back to normal".
Her doctors tried three different statins on her, but each one had the same effect. She has stopped them altogether now and is trying to reduce her cholesterol count with diet and exercise. She said she was back doing voluntary work at her local school. In her story to the researchers she said:
"I feel very blessed; I got about 99 per cent of my memory back. But I worry about people like me who are starting to lose their words who may think they have just normal aging and it may not be."
There are many doctors, and cardiologists in particular, who are not worried about these stories. For them, the risks are very small compared to the benefits of statins.
Antonio Gotto, past president of the American Heart Association and currently dean of the Weill-Cornell Medical School, told the WSJ:
"I would hate to see people frightened off taking statins because they think it's going to cause memory loss."
Part of the difficulty for doctors is pinning down exactly what constitutes thinking and memory problems, and distinguishing an effect of one drug from what could be a gradual effect from a separate unrelated cause, for instance as an age progressive condition or side effect from other drugs.
The important thing is to keep a close eye on a patient who is put on statin for the first time, or changes from one type to another, and if there is a sudden onset of thinking and memory problems, and these wear off when they are taken off the drug, then perhaps trying an alternative is advisable.
Gayatri Devi, associate professor of neurology and psychiatry at New York University School of Medicine told the WSJ she had seen half a dozen patients in over ten years of practice whose cognitive skills changed very soon after starting on a statin, and returned quickly when they stopped. It might just be a handful of patients, she said, but "for them, it made a huge difference".
Lipitor is a prescription drug used with a low fat diet and exercise to reduce cholesterol. It is prescribed for patients with multiple risk factors for heart disease (such as family history, high blood pressure, age, low "good" HDL cholesterol, or smoking), to reduce the risk of heart attack and stroke. It is also used by patients with type 2 diabetes and one other risk factor for heart disease.
Lipitor should not be taken by anyone with liver problems, nursing mothers, and women who are or could become pregnant.
*Project ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's motor neurone disease) campaigns to raise awareness and better treatments for ALS, which attacks neurones in the spine and parts of the brain.
Click here to read the full story in the Wall Street Journal.
Sources: Wall Street Journal, New York Times, Project ALS, Pfizer Inc website.