More bitter pills for the pharmaceutical industry

These continue to be less-than-happy times in certain corners of the pharmaceutical industry. Day by day, bad news accumulates. Even the industry's trade organization, the Pharmaceutical Research and Manufacturers Association (PhRMA), acknowledges that something has to give. Where are the unpleasantness and pressure coming from?

• Propulsid (cisapride), once commonly prescribed for infants with gastroesophageal reflux disease, is on a list of drugs like Vioxx (rofecoxib) and Bextra (valdecoxib) that have been linked to severe cardiac side effects. Yet, according to documents obtained by the New York Times from lawsuits, "dozens" of studies that might have warned physicians away from using the drug were never published. Propulsid was pulled from the market in 2000.

• Editors of several major medical journals-the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine among them-have accused manufacturers of failing to live up to their promise to provide meaningful data on clinical trials of their products, and are calling on all parties to register fully all new and ongoing clinical trials. Pfizer, one of the companies labeled "noncompliant" by the editors' group, denied the allegation and revealed plans to post more than 400 trials by October.

• The Accreditation Council for Continuing Medical Education (ACCME) is cracking down even harder on continuing medical education (CME) courses to diminish the influence of pharmaceutical manufacturers on CME course content. Guidelines issued by the ACCME in May require instructors to disclose ties to industry and resolve any conflicts of interest before a course begins.

• A Congressional report charges that fewer than one half of post-market studies promised as a condition of accelerated FDA approval of new drugs are actually completed. Congressman Edward Markey (D-Mass.) has introduced a bill that would levy heavy fines on companies that fail to conduct post-market studies in a timely manner and would give the FDA authority to order such studies on products that have been given accelerated or standard approval.

• A study published in the New England Journal of Medicine finds that US medical schools allow manufacturers a substantial degree of influence on industry-funded studies that the schools conduct. In a number of the contracts that the study examined, researchers are prohibited from disclosing their results without industry approval.

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