Should women who have paid for statins be given their money back?

Cholesterol-reducing drugs known as statins are hugely popular and highly profitable. It’s a shame, then, that they aren’t very effective. I say this because while they have been shown to reduce the risk of cardiovascular events such as heart attacks, they do not reduce the overall risk of death when essentially healthy individuals are being treated. This was the conclusion of an analysis of 8 studies which had been performed using individuals with no previous diagnosis of cardiovascular disease [1]. This analysis also revealed that for one individual to be protected from a cardiovascular event (heart attack or stroke) over a 5-year period, 67 people would need to be treated.

Other evidence analysing the effectiveness of the national treatment guidelines in the USA, Canada, the UK and New Zealand has revealed the so-called ‘number needed to treat’ (NNT) varies from 108-198 [2]. These startlingly high NNTs have caused some to question whether statins are really the wonder drugs some would have us believe them to be.

But wait, it gets worse. Because the limited ‘benefits’ of statins seems to be confined mainly to men. The research has found that even in women with diagnosed cardiovascular disease and/or history of heart attack or stroke, statins do not reduce overall risk of death. And in healthy women, they don’t reduce the risk of cardiovascular events (heart attacks and strokes) either. The crashing failure of statins in women was fully elucidated in an analysis from British GP Malcolm Kendrick in the BMJ last year [3].

The singular failure of statin drugs to help women was highlighted this week in the British Medical Journal [4]. In a news piece, our attention was brought to an analysis from a professor of law and a professor of clinical epidemiology in the USA. The paper focuses on the most widely prescribed statin of all – atorvastatin (Lipitor) [5]. It looks at the evidence for the effectiveness of this drug in treating essentially women with no history of cardiovascular disease. In line with previous evidence on statins, there was no significant benefit to be found.

But the authors of this analysis go further by questioning the fact that when Lipitor is promoted and advertised, there’s plenty of talk about the fact that it reduces the risk of heart attacks, but no mention of it’s stunning lack of success with regard in women. They accuse Lipitor’s manufacturers of a lack of candour here, and also ask questions of the Food and Drug Administration (FDA) in the USA. At a bare minimum, they say, the FDA should be using its muscle to protect people against misleading marketing. They also suggest that women who have paid out of their pockets as a result of false promises should be compensated for the money they’ve effectively wasted.

The authors conclude: Our findings indicate that each year reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.

According to the BMJ new piece, Pfizer have responded to the article in the form of a statement, which I can’t locate on the web. In this statement, Pfizer claims that “Cardiovascular disease is a major cause of death in women as well as men and it ultimately kills as many women as men. However, onset of disease is delayed by some 10-15 years in women compared to men; thus the National Institutes for Health (NIH) ATP III guidelines define age as a risk factor in women at age 55, compared to age 45 for men. In addition, the AHA CVD Guidelines for Women were updated in 2007 and recommend that healthcare professionals should focus on women’s lifetime heart disease risk, not just short-term risk.”

Let this not distract us from the fact, I say, that statins have not been shown to benefit essentially healthy women. And let’s not forget either that for each person that benefits from taking statins, many, many others don’t.

References:

1. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007;369:168-169

2. Manuel DG, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modeling study. BMJ 2006;332:1419

3. Kenrick M. Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No. BMJ 2007;334:983

4. Dobson R. Atorvastatin advertising misled over benefits for women, study claims. BMJ 2008;337:a2209

5. Eisenberg T, et al. Statins and Adverse Cardiovascular Events in Moderate-Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims. Journal of Empirical Legal Studies. Published Online: Sep 5 2008

6 Responses to Should women who have paid for statins be given their money back?

  1. Gordon 25 October 2008 at 4:15 pm #

    The popularity of statins is due to clever marketing. not proper medical evidence. Big Pharma hes done it again, and as they did with flu jabs the drug companies have convinced most of the medical establishment that statins are a must for millions of people who in fact have absolutely no need of them. The catastrophic effects statins cause by the destruction of CoQ10 have been ignored or suppressed. But that’s all right because it gives Big Pharma an opportunity to create another drug to treat people for the effects of taking statins. Long live polypharmacy!

  2. helen 26 October 2008 at 10:25 pm #

    their money should definitely be refunded as well as the doctor’s fee honestly the way the illness industry is being run today why would anyone pay someone to keep them sick??

  3. Hilda 27 October 2008 at 5:40 pm #

    Dr Briffa , Why not write something about yte dangers of vegetable oils. This is something the public do not know enough about and it is in almost every processed food.

  4. Cybertiger 2 November 2008 at 11:27 pm #

    “They also suggest that women who have paid out of their pockets as a result of false promises should be compensated for the money they’ve effectively wasted.”

    And what about the NHS and the taxpayer who funds it? I would suggest that both should be compensated for that utter waste.

  5. GB 1 July 2009 at 6:51 pm #

    Just google statin scam and you will see a lot of info much more heavily weighted against statins. There are conflicting studies that say the people with the highest cholesterol live the longest. My doctor wanted me on them and recommended me to a special heart clinic even though my numbers are not high. I declined. Take your health into your own hands. Even the doctors do not know the truth. Especially when the statin producers are paying for the studies and throwing away the bad results then playing up the good results. If you think we are protected by Government just look at the stock market!

  6. LS 6 July 2009 at 11:46 pm #

    The minefield that is statin prescription grows and grows. I have just been advised to see a lipospecialist because of high cholesterol but my factor of hypothyroidism and a high TSH has been scarcely dealt with. I wonder how any of us will ever be able to make decisions if the apparent level of misinformation dominates decisions of the very health professionals we rely upon.

Leave a Reply to Gordon Click here to cancel reply.