Drug company accused of hiding hazards of diabetes drug rosiglitazone (Avandia)

Rosiglitazone is a drug used in the treatment of type 2 diabetes. Back in 2007 it emerged that this drug posed significant risks to the heart health of those who took it. These facts only emerged, however, as the result of independent analysis of data that rosiglitazone’s manufacturer, GlaxoSmithKline (GSK) had been forced to publish on their website.

The fact that GSK was made to published this damning data (and did not give it up voluntarily) is bad enough. But now it looks as though the risks of rosiglitazone have been known to GSK and its previous incarnation (SmithKline Beecham) for more than a decade. This accusation comes as a result of documents seen by the New York Times. See here for the full story

According to the New York Times, SmithKline Beecham began a study back in 1999 which pitted rosiglitazone against a rival drug pioglitazone (Actos). The results were not what SmithKline Beecham executives were hoping for: not only was rosiglitazone no better in treating diabetes than pioglitazone, its posed significantly greater risks in terms of heart-related complications.

Findings such as these are obviously disappointing for drug company executives and the shareholders they seek to serve, but they have obvious relevance to those taking the drug, as well as the doctors who advise on its use and prescribe it. Here, from the New York Times article, is an excerpt from an internal email written by former SmithKline Beecham executive Dr Martin Freed in 2001: “Per Sr. Mgmt [senior management] request, these data should not see the light of day to anyone outside of GSK.”

Another shocking revelation comes in the form of what appears to be a cost relationship between GSK and certain elements within the Food and Drugs Administration (FDA) in the US. The FDA recently considered whether or not rosiglitazone should be pulled from the market, but in the end decided it should not. One of those arguing for the retention of this drug was Dr John Jenkins, director of the FDA’s office overseeing new drugs. According to the New York Times, Dr Jenkins briefed GSK extensively on the debate going on within the FDA.

If any of this is sounding remotely familiar, that might be because another apparent example of a drug company hiding data that caused significant suffering and cost many their lives came to light last year. It concerned the drug company Merck’s burying of data regarding the safety of its painkilling drug rofecoxib (Vioxx). See here for more about this.

I find it depressing and saddening that what we have here are apparent examples of drug companies allowing individuals to expose themselves to secretly known risks that could cost them their lives. But it’s not all doom and gloom. There was a time, I suppose, where drug companies had little fear of being called to account. Now, even with friends in high places, pharmaceutical companies are finding it harder to put profit before people.

8 Responses to Drug company accused of hiding hazards of diabetes drug rosiglitazone (Avandia)

  1. hans keer 14 July 2010 at 8:31 am #

    You are totaly right again doc. When you think about it that there are people in those pharma companies who actually know about those secret risks. They don’t care at all about their “target group”. But unfortunately it’s not only pharma where this happens. The food and medical industry know their way around. Not to speak about health organizations and politicians. On our blog, we call this ABUSE http://bit.ly/9tfUxb. VBR

  2. Jamie 14 July 2010 at 12:39 pm #

    Spot on Hans… We are often quick to jump all over Big Pharma, but Big Tobacco, Big Food, Big Alcohol… all follow the same formula more or less.

    Have a read of;

    The Perils of Ignoring History: Big Tobacco Played Dirty and Millions Died. How Similar Is Big Food?
    KELLY D. BROWNELL and KENNETH E. WARNER

    http://www.yaleruddcenter.org/resources/upload/docs/what/industry/FoodTobacco.pdf

  3. Chris 16 July 2010 at 10:34 am #

    The Guardian have taken up with a story on rosiglitazone (Avandia) and GSKin todays’ printed edition (16 July 2010), I think. Link to the online article, here. The Guardian reports GSK have taken a hit of £1.57bn in legal charges and settlements following proceedings involving rosiglitazone (Avandia) and Paxil.

    The quote further down the story caught my attention:
    “The charge we have announced today reflects the company’s ongoing efforts to resolve certain long-standing legal cases,” said Dan Troy, general counsel of Glaxo.
    “This represents a substantial proportion of Glaxo’s outstanding litigation. This progress is helping us to reduce financial uncertainty and risk for shareholders.”

    Is one to conclude that GSKs activities are all about delivering a return of monetary value to themselves and their shareholders with total disregard regard for the social costs that may be intrinsic to the pills they peddle?

  4. Margaret Wilde 16 July 2010 at 11:28 pm #

    The perpetrators of these cover-ups should be prosecuted in the criminal courts. Where their withholding of evidence of adverse reactions results in the prescribing of a useless, dangerous drug that results in certain people suffering illness/disability/premature death then the charge should be something like Grievous Bodily Harm or Manslaughter or Corporate Manslaughter, and the sentence passed if proved guilty should be severe enough pour discourager les autres – i.e. some of these guys should end up in prison for a long time.

    Mere fines, however large, do not deter Big Pharma.

  5. Carol 17 July 2010 at 12:49 am #

    I read these stories with dismay but I’m never surprised. I worked in the medical industry for most of my working life. It is mostly staffed by good people but with the bottom line as the ONLY consideration. Management is driven purely by money, despite their high-minded talk of benefitting patients. They spend more money on marketing than on real R&D and the most terrible truth is that these companies employ doctors whose solemn oath is “first do no harm”. Where were they when these results were being buried?

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  1. Paleolithic Solution « - 15 July 2010

    [...] Drug company accused of hiding hazards of diabetes drug [...]

  2. Perfect Health Diet » Items That Caught My Eye - 17 July 2010

    [...] Dr. Briffa comments on a New York Times story that a drug company hid evidence from clinical trials that their drug was deadly. This sort of behavior is outrageous but, alas, only too common.  Some treatments have about as much substance to them as Bernie Madoff’s hedge fund: they thrive, but only because of dishonesty by their developer and polite aversion of the eyes by everyone else. [...]

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