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  • STATIN NATION: The Great Cholesterol Cover-Up
    STATIN NATION: The Great Cholesterol Cover-Up
    Rethink Productions
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    Entries in MHRA (1)

    Wednesday
    Feb242010

    Should Drug Companies Be The Only People Doing Research?

    There was a discussion recently in the British Medical Journal (BMJ) about the many problems associated with drug companies doing most of the research on their own products. Thankfully, these issues are now becoming more widely known and they were briefly discussed on BBC Radio 4.

    The discussion was between Ben Goldacre and Vincent Lawton.

    Ben Goldacre is a doctor who writes the Bad Science column in the Guardian newspaper. Personally, I do not always agree with his analysis of some issues but on this occasion he has hit the nail squarely on the head.

    In the BMJ, Ben Goldacre provides a brief summary of the main problems associated with drug companies sponsoring most of the research (1). He clearly explains how doctors can be misled by pharmaceutical companies not publishing the negative research finding associated with their drugs. He also describes how these companies can publish the same positive study several times (each in a slightly different way but using the same data) – the positive results from one trial then create the impression that several different positive studies have been done.

    In the same BMJ article, in order to counter these arguments, Vincent Lawton provides a case for drug companies being in the best position to do the research (2).

    Vincent Lawton admits that the current system is not perfect, but goes on to vaguely suggest that things will get better by drug companies regulating themselves better. He also suggests that research being done by drug companies leads to greater innovation.

    This greater innovation, in my view, is difficult to accept. It is well known that the pharmaceutical industry is trying to deal with a crisis – in recent years there have been a distinct lack of innovate drugs. A large number of commentators have raised this issue. For example, the statement below is taken from an official journal of the Canadian College of Family Physicians:

    “Most “new” products brought to market since the 1990s have not substantially improved on the medical benefits provided by older, less costly drugs whose risks were well known. These new products are “me-too” drugs.....Most do not represent genuine therapeutic advances or meet those needs perceived by family physicians. They do, however, increase drug consumption. Technologic innovation does not equal therapeutic progress (3). “ 

    This lack of meaningful innovation has led to drug companies having to get more people to take existing drugs. They do this by creating a society of the worried-well and by making people fear suggested risk factors (like cholesterol).

    So who is Vincent Lawton? You might think that he works for a large pharmaceutical company. No, he is actually an executive director of the MHRA – the UK organisation that decides whether or not drugs should be approved for use.

    Why does a director of the MHRA have such a favourable view of the pharmaceutical industry? Do potential conflicts of interest exist between the MHRA and pharmaceutical companies?

    The MHRA recently conducted a safety review of cholesterol-lowering statin drugs (4). It concluded that statins are associated with a greater risk for depression, sleep disturbances, memory loss, sexual dysfunction, and lung disease. However, statins have been shown to also increase the risk for other more serious problems.

    Studies have shown that statins increase the risk for type 2 diabetes and they also increase symptoms associated with heart failure. There are also unresolved questions concerning statins and cancer.

    The recent MHRA safety review should have provided an opportunity to investigate these risks but there was no mention of the 3 more serious conditions anywhere in their report. 

    References:

    1. Goldacre, B. Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes. BMJ 2009;339:b4949 

    2. Lawton, V. Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? No. BMJ 2009;339:b4953 

    3. Biron, P et al. Pharmas-co-dependence exposed. Can Fam Physician 2007;53(10):1635–1637 

    4. MRHA Public Assessment Report, Statins: updates to product safety information Nov 2009