US clinical guidelines often influenced by industry, NEJM says

BMJ 2007; 334 doi: (Published 25 January 2007) Cite this as: BMJ 2007;334:171
  1. Janice Hopkins Tanne
  1. 1New York

    Many clinical guidelines for doctors in the United States are influenced by the pharmaceutical industry and special interest groups, said an article in the New England Journal of Medicine last week (2007;356:331-3).

    “The quality of guidelines varies considerably,” and some are controversial, says a commentary by the journal's national correspondent, Robert Steinbrook.

    Meanwhile, the National Institutes of Health (NIH) cancelled a conference that it had planned on guidelines for screening pregnant women for herpes, after it received a protest letter from the Center for Science in the Public Interest. The organisation's letter said that four out of five of the speakers had undisclosed ties to drug firms that made antiviral drugs (BMJ 2007;334:115).

    The letter was signed by Richard Horton, editor of the Lancet; two former editors of the New England Journal of Medicine, Marcia Angell and Jerome Kassirer; 41 other physicians and scientists, including the head of the US Cochrane Collaboration, and many organisations.

    The New England Journal of Medicine's critical commentary said, “At present, the ties between guidelines panels and industry are extensive. A survey of 685 disclosure statements by authors of guidelines concerning medications found that 35% declared a potential conflict of interest.”

    There are more than 2000 guidelines in the US National Guideline Clearinghouse (

    “Guidelines have … been questioned when pharmaceutical and medical-device companies with a financial stake in the outcome provide substantial funding for their development and implementation,” the journal says.

    Guidelines might be improved by the US setting up an organisation like the UK National Institute for Health and Clinical Excellence (NICE), which decides which drugs and treatments are available on the NHS. In the US, the National Institutes of Health consensus development programme ( sponsors evidence based evaluations, using literature review and public meetings with research presentations, which include jurors and witnesses.

    Panel members cannot have financial or other conflicts, and they are independent of the NIH and the Department of Health and Human Services. Speakers at the conference may have ties to industry, but these are disclosed. However, the process is slow and expensive.

    The Agency for Healthcare Research and Quality does not prepare guidelines, but each year it sponsors 20 or 25 systematic reviews that give public and private organisations a scientific foundation for developing guidelines. However, the agency is not able to fund as many reviews as are proposed.

    Guidelines developed by professional organisations and societies that represent medical specialties “have diverse policies for corporate sponsorship of guidelines and the financial associations of committee members,” the journal says.

    Guidelines would best serve doctors and patients if they were developed by independent experts without funding from self interested groups or industry. The journal suggests three possible approaches: expanding the NIH's consensus development programme, requiring the healthcare quality agency to support development of guidelines, or creating a US version of NICE.

    Any system “would need independence and financial security: when powerful interests take issue with guidelines, challenges will be inevitable,” the journal says.

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