Remember that vaccines are drugs and subject to the same problems re: research as all drugs. - SM

http://www.guardian.co.uk/uk_news/story/0,3604,549283,00.html

Drug firms accused of distorting research

Sarah Boseley, health editor

Monday September 10, 2001

The Guardian

Thirteen of the world’s leading medical journals today mount an outspoken attack on the rich and powerful drug companies, accusing them of distorting the results of scientific research for the sake of profits.

The Lancet, the New England Journal of Medicine, the Journal of the American Medical Association and other major journals accuse the drug giants of using their money - or the threat of its removal - to tie up academic researchers with legal contracts so that they are unable to report freely and fairly on the results of drug trials.

The scientists, often from cash-starved university departments, may be prevented from having access to the raw data gathered in the trial which would tell them how well or not the drug worked and whether there were side-effects. They may be given no say in the way the trial is designed and they may have only limited participation in interpreting the results.

“These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavourable to the sponsor’s product,” says the commentary which will run this week in 12 of the journals. The British Medical Journal is running a separate editorial with the same message.

The editors say that the study produced for publication may be skewed in the interests of the pharmaceutical company, which hopes to make big profits from a new drug. It is also a betrayal of the patient who has agreed to take part in what he or she believes is research to help find new and better treatments for disease.

Richard Horton, editor of the Lancet, said the editors hoped to start a debate over what patients are told when they sign a consent form to take part in a trial.

“The patient should know who is in control of the study. Are you - my doctor or the scientist doing the study - in control or is the pharmaceutical company in control? They are never told anything of the sort. At the moment, informed patient consent is a fabrication.”

Academic scientists had little choice but to accept the restrictions imposed on them, he said, because they knew that otherwise the funding they needed for research would go to the increasing number of private contract research organisations. Those organisa tions last year in the USA received 60% of the research grants handed out by pharmaceutical companies.

Where the company controls the trial, the data and the writing of the study, he said, “the research will be presented to favour the product that company makes. I think it happens all the time - certainly in most papers that involve a new drug. It’s obvious that that will happen. For the company it is their profit we are talking about. There is a clash of interests”.

The editors intend to take action, by requiring all authors to disclose details of their own and the sponsoring pharmaceutical company’s roles in the study.

Some editors will be asking for a signed declaration from the author that they accept responsibility for the trial. If the company has sole control of the data, the journals will not publish the study.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.