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The changing landscape

The changing landscape of pharmaceutical medicineExamine the sweeping changes taking place in pharmaceutical medicine including a new code of conduct, federal regulations and industry changes designed to improve drug companies' standards and elevate their performance.

Now available without

Now available without a prescription - FDA makes more drugs over-the-counter - includes related articles on Nicotrol and RogaineFor those who yearn to break their cigarette addiction but don't fancy a trip to the doctor's office, the ability to get the nicotine patch without a physician's prescription may be just what the doctor ordered.

FDA ensures equivalence

FDA ensures equivalence of generic drugs - Food and Drug Administration - includes related articles on bioequivalency and filling prescriptionsWhen Stuart Addison goes to the pharmacy in Margate, Fld., he has the pharmacist fill his prescriptions with generic drugs. Addison. a retired federal government auditor, is one of many Americans who are choosing genetics when they buy drugs.

Pharmaceutical industry issues

Pharmaceutical industry issues its plan for voluntary clinical trials registryIn the face of bad publicity and impending restrictions, trade groups representing pharmaceutical companies have proposed a voluntary plan for using a clinical trials registry as well as results databases by midyear.
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Medical societies accused of being beholden to the drugs industry - News - Statistical Data Included

Medical societies accused of being beholden to the drugs industry - News - Statistical Data IncludedSome prestigious medical organisations are coming under criticism for being too beholden to the pharmaceutical industry for their income.

In a study published in the Western Journal of Medicine Dr Peter Glassman, of the University of California in Los Angeles, and colleagues charged that the increasing reliance of doctors' organisations on pharmaceutical advertising is placing the medical organisations in jeopardy of losing their objectivity.

In their study the authors evaluated the primary clinical journals of several leading medical organisations, including the Journal of the American College of Cardiology, Annals of Internal Medicine, Journal of the American Medical Association, American Journal of Respiratory and Critical Care Medicine, Clinical Infectious Diseases, and the New England Journal of Medicine. They found that the estimated revenue from pharmaceutical advertising ranged from $715000 (450 000 [pounds sterling]) to $18m--a total that they said could place the organisations in a position of dependency. Five organisations raised more than 10% of their gross income from a single journal's pharmaceutical advertising, and four organisations raised as much or more from pharmaceutical advertising as from members (Western Journal of Medicine 1999;171:234-9).

In a separate article published in the Los Angeles Times on 21 October 1999, reporter Terence Monmaney charged that the New England Journal of Medicine had violated its own ethics policy numerous times in the past three years. It did so by publishing articles by researchers with drug company ties and not disclosing the potential conflicts of interest.

A similar report was published in the New England Journal of Medicine; this found that almost every scientist defending the safety of calcium channel antagonists (whose use is sometimes controversial) had unpublished financial ties to manufacturers of these drugs (1998;338:101-6).

"We believe much more explicit disclosure procedures should be used for written publications," said Dr Allan Detsky, professor of health administration and medicine at the University of Toronto and one of the authors of the New England Journal's study.

"Right now, almost all journals will ask for disclosure, but it's done in a relatively loose way, letting the authors write down anything they want," he added.

In Mr Monmaney's report published in the Los Angeles Times, an analysis of 36 "drug therapy" review articles published in the New England Journal of Medicine since 1997 identified eight articles by researchers with undisclosed financial links to drug companies that marketed treatments evaluated in the articles.

Among the articles questioned was a 1997 review of treatments for multiple sclerosis in which the lead author of the study had received research funds and speaking fees from multiple companies that make drugs assessed in the article (according to the Los Angeles Times).

The newspaper also reported that the sole author of a 19'98 review of breast cancer treatments belatedly said that he had received consulting fees from multiple companies that make drugs assessed in the article.

The Los Angeles Times conducted the analysis after it was widely reported in September that the New England Journal of Medicine ran a review of treatments for hair loss by a researcher alleged to have undisclosed financial ties to the pharmaceutical companies that market the hair loss treatments Rogaine and Propecia. (1999;341:964-9). The lead author of that study, Dr Vera Price, professor of clinical dermatology at the University of California in San Francisco, served as a paid consultant to the drugs' manufacturers.

According to the Los Angeles Times, she did not disclose these ties to the NEJM, but Dr Price has said on the journal's website that she did so verbally to the commissioning editor.

The Western Journal of Medicine is owned by the BMJ Publishing Group.