4th October 2001
The Government promised a large increase in the grant to the Health Research Board recently and, no matter how difficult times may be for Charlie McGreevey, Minister for Finance, it is essential we all make sure this money materialises. Now is the time when items like this can get side tracked in the Department of Finance but State funding is essential for medical and scientific research. Funds from the pharmaceutical and biotechnology firms are, of course, welcome but it is vital researchers do not become dependent on them.
On holiday in Italy I read an interesting article in the International Herald Tribune, a daily paper I don't read that often but do find interesting. The headline in the paper on Monday, 6 August 2001 was "Medical Journals Try to Curb Drug Companies' Influence on Research". When Dr. Marcia Angell retired from the editorship of the New England Journal of Medicine she wrote about the concerns she had regarding which drug trials could really be described as independent. She wrote that there was more and more difficulty getting independent reviewers for articles on the results of such trials. She expressed particular concern about multicentre trials where all results were sent back to the pharmaceutical firm, the data analysed there and the article written by employees of the company. Other editors have now voiced similar worries and joint action is under way.
The Herald Tribune said that the editors of the journals who have decided to take action include the New England Journal of Medicine, The Lancet, The Annals of Internal Medicine and the Journal of the American Medical Association. The editors have agreed to reserve the right to refuse to publish studies sponsored by drug companies unless the researchers involved are guaranteed scientific independence. They hope to give researchers more leverage in their dealings with pharmaceutical companies because the companies involved are, of course, anxious to have the trials published in prestigious journals because doctors view them, to quote the Herald Tribune, "as credible sources of information to help them decide which drugs to prescribe".
The editors point out that in recent years drug companies have become the dominant funders of biomedical research, especially of large studies of medicines' safety and effectiveness. The companies usually collect and analyse the data and the companies do have a huge financial stake in the results.
A spokesperson for the Pharmaceutical Research and Manufacturers of America called the journal editors’ concerns "patently absurd". But the editors responded with a few worrying examples that trouble them and I quote them from the Herald Tribune Article:
"In a case last year, researchers at the University of California at San Francisco defied a corporate sponsor by publishing a study concluding that Remune, a vaccine-like product developed as an HIV therapy, did not benefit patients who were already receiving standard treatments.
"The company, Immune Response of Carlsbad, California, is seeking $7 million to $10 million in compensatory damages from the university for harming its business.
"Nancy Olivieri, a University of Toronto physician, lost her research contract with Apotex, a Canadian drug company, after she spoke out and published an article in 1998 about a serious side effect of deferiprone, a drug for a blood disorder. Dr. Olivieri's contract with Apotex contained a non-disclosure clause.
"Elie Betito, director of public and government affairs for Apotex, said Dr. Olivieri's contract was terminated because she failed to follow the protocol for how the study should be carried out, not because she published her findings.
"In the early 1990s, Betty Dong, a pharmacologist at the University of California at San Francisco, found that cheaper generic versions of thyroid hormone worked as well as Synthroid, the brand-name drug whose maker had funded the research. The company, Knoll Pharmaceuticals, blocked publication of her findings for seven years.
"In 1999, Knoll agreed to pay 37 states almost $42 million to settle a suit alleging that it had made false claims that Synthroid was superior to competing brands and had interfered with the publication of the study."
Anyone who has been involved in medical research which does not involve the use of pharmaceutical products will know how difficult raising money for research is. It is not unreasonable that pharmaceutical companies should have less interest in trials which involve change in life style for example, because their business interests and responsibilities to shareholders are little served by supporting such work. Some firms, despite the fact that there is no need for them to do so, actually do set up stand alone research institutions, the Wellcome Foundation being the outstanding example which at one stage contributed more money to medical research in Ireland than the State.
I have not heard of any inhibition on publication being put on a researcher in Ireland by a sponsor but it is worrying to see the concerns expressed by the eminent editors. Let us keep an eye on the Department of Finance and make sure the promised money reaches the Health Research Board.
Senator Mary Henry, MD
