Under Fire from Pharma, German Institute May Lose Its Director (UPDATED)

A long-running feud between pharmaceutical companies and the German institute that evaluates the effectiveness of medical treatments could cost the institute director his job. Although the post is supposed to be apolitical, members of Germany’s new coalition government have called for Peter Sawicki, founding director of the Institute for Quality and Efficiency in Health Care (known by its German acronym IQWiG, pronounced ICK-vig), to be replaced with someone who is friendlier to the pharmaceutical industry. The institute’s board of directors is expected to decide on 20 January whether Sawicki, a clinical researcher and diabetes expert, will be replaced when his contract runs out later this year.

Sawicki’s supporters say the move would endanger the institute’s reputation for impartial and rigorous science, and earlier this month a petition signed by 600 doctors and clinical researchers called on the health minister and the board to keep Sawicki on. Gerd Antes, director of the German Cochrane Centre in Freiburg, a not-for-profit organization that analyzes health care effects, says that replacing Sawicki would significantly undermine IQWiG and its work. Antes views the anti-Sawicki push as “part of the political game to soften and to weaken rigorous procedures for new drugs and medical devices in Germany.”

IQWiG, based in Cologne, was started in 2004 as part of a reform of the German health care system. With a function similar to that of the U.K.’s National Institute for Health and Clinical Excellence (NICE), IQWiG’s reports inform the panel that decides which treatments are covered by Germany’s publicly funded insurance plans. Sawicki has tussled with drug companies over access to their unpublished studies and over reports from the institute, such as the one that found “no evidence” that a new product was superior to older synthetic human insulin. Industry groups, especially the German organization of research-based pharmaceutical companies, the VFA, have been highly critical of IQWiG, saying, for example, that IQWiG is too selective in deciding which studies to include in its evaluations.

Big pharma’s attacks have even come from outside Germany. In March 2009, the Pharmaceutical Research and Manufacturers of America petitioned the Obama Administration to put Germany on a trade and intellectual property “priority watch list” chiefly because of IQWiG’s influence on the German drug market. The petition complained that the institute has “inadequately taken into account the value of innovative pharmaceuticals,” among other complaints. The Obama Administration declined to put Germany on its watch list.

Sawicki acknowledges that it is difficult for new drugs or techniques to make the grade. “We have introduced a method based on patient-relevant outcomes: morbidity, mortality, and quality of life,” he says, while avoiding what he calls “invalid surrogates,” such as cholesterol levels or bone density. “You can lower cholesterol and increase mortality. You can lower blood pressure and increase heart failure,” he says. Second, he says, “we are looking for progress” rather than just effectiveness, which means that an innovation is not compared with a placebo but with the current standard of care. “We are trying to answer the question: ‘Is it better?’ ” Sawicki says he has some sympathy for the drugmakers: “It is very difficult to produce something better than what we already had.”

Industry complaints about the institute have found some support among German politicians. In the October agreement forming Germany’s new governing coalition, the parties stated their intention to examine IQWiG’s methods, with the goal of “increasing the acceptance of the institute’s findings among patients, caregivers, and producers.” In late November, German media reported that a white paper circulated among top health policymakers called for Sawicki to be replaced and for the institute to be made more industry-friendly. Sawicki is also facing an ethics inquiry, which he says he requested after a new finance director found irregularities in expense accounts. News of the inquiry, which reportedly involves several hundred euros in travel expenses (see update below), leaked when the white paper was circulated.

The institute’s work is bound to be controversial, says Antes. Similar research in the United States has also drawn criticism. Although Sawicki’s term hasn’t been flawless, Antes says, he has been instrumental in getting the institute up and running. “He never gives in. He has a very strong spine. In 5 years, they have established an institute with a very good international reputation.”

UPDATE

Details of the ethics inquiry surrounding Sawicki’s expenses have been leaked in the run-up to Wednesday’s decision. Investigators found that Sawicki booked business-class tickets for domestic flights and improperly claimed more than €1100 worth of private costs, most of which he has since paid back. According to Handelsblatt (in German), which obtained a copy of the confidential report, Sawicki also leased an Audi Q7 in 2006 and an Audi Q5 in 2009 as official cars, although he had agreed to use his private car for business and receive compensation. Handelsblatt reports that the investigators found, however, that Sawicki had tacit approval for the leasing arrangement, in part to compensate for a pay cut that Sawicki experienced when he took the director job.

Posted in Europe, Health IQWiG