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Head of German NICE was sacrificed to satisfy drug industry, says German health expert

BMJ 2010; 340 doi: http://dx.doi.org/10.1136/bmj.c1115 (Published 26 February 2010) Cite this as: BMJ 2010;340:c1115
  1. Annette Tuffs
  1. 1Heidelberg

    The German government has sacked the head of the Institute for Quality and Efficiency in Health Care (IQWIG) to placate the drug industry, a German MP and professor alleged in an interview with the BMJ.

    In January the board of directors of IQWIG, the German equivalent of the United Kingdom’s National Institute for Health and Clinical Excellence (NICE), agreed Peter Sawicki’s dismissal, saying, “The excellent work of the institute should not be burdened with discussions about irregular administrative procedures.” Dr Sawicki had been accused of irregularities over his expenses claims, including the use of his business car and petrol for his lawnmower (BMJ 2010;340:c499, 26 Jan, doi:10.1136/bmj.c499).

    Karl Lauterbach is certain, however, that the real reason for Dr Sawicki’s dismissal is pressure from drug companies in Germany and from abroad to which the German government, a coalition of the Christian Democrats and the liberal Free Democratic party, has bowed.

    In a letter to the new German government last year several Christian Democrats demanded a change of direction in the policy and leadership of the institute to make it more acceptable to the drug industry.

    Furthermore, health experts in the Free Democratic party have claimed that Germany’s standing as a manufacturing and business centre for the drug industry means that the country should extend more friendly terms to drug companies (BMJ 2010;340:c318, 18 Jan, doi:10.1136/bmj.c318).

    Dr Lauterbach, a member of the German parliament from Cologne and professor for health economics at Cologne University, believes that the government succumbed to these arguments, even though Dr Sawicki had strong support from the medical profession. Dr Lauterbach is a close associate of the former Social Democrat health minister Ulla Schmidt, who established IQWIG in 2004.

    Dr Sawicki sees evidence for successful pressure from the industry in the fact that his dismissal had been forecast to him by a representative of the German association of pharmaceutical firms in November 2009, shortly after the election.

    A document published in 2009 by the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents leading drug firms in the United States, outlined economical risks in the international market and listed Germany as one of the top priority countries for US political action. The document claimed that the German institute discriminates against innovative drugs and should therefore be put on the priority watch list for economic sanctions, together with other countries such as China and India, which are ignoring patents (www.phrma.org/files/attachments/PhRMA%20Special%20301%20Submission%202009%5B2%5D.pdf).

    The cost-benefit analyses developed by IQWIG are also seen as barriers against the US drug industry, because they limit reimbursements and place restrictions on patients’ access to information about innovative drugs through advertising of prescription drugs. In the PhRMA document IQWIG is accused of “considering only limited data to substantiate the value brought to patients and payers by new medicines.”

    Furthermore, the document says that there is insufficient interaction and exchange between drug manufacturers and IQWIG during the drug evaluation process. Companies are allowed only to provide comments on report plans and preliminary reports: if they want to appeal against IQWIG decisions on which drugs will be funded, they must go through the courts.

    The PhRMA document says, “We would like to see the Commerce Department and other agencies move rapidly to advance the bilateral dialogue with Germany.”

    Dr Lauterbach is certain that Dr Sawicki is the victim of the international drug industry. “Apart from a few doctors closely linked with the pharmaceutical industry, the medical community in Germany backed him,” he said. Recommendations by IQWIG, especially on antidiabetes drugs and anticancer drugs, provoked the industry, he said.

    The accusations against Dr Sawicki concerning the wrongly claimed expenses and the business car he sees as mere pretence to get rid of someone with whom the industry is uncomfortable. “If he had done something wrong, the board of directors would have had to claim compensation from Sawicki, but they never did,” says Dr Lauterbach.

    The future of IQWIG is uncertain, because its teeth have been drawn, he said. He predicts that IQWIG will lose its international standing as pressure from the industry encroaches on its decision making.

    Notes

    Cite this as: BMJ 2010;340:c1115