Medical journals set stricter rules for studies
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By André Picard
In an unprecedented move, the editors of the world's leading medical journals have banded together and vow to no longer publish articles in which scientific objectivity is in question.
The journals are concerned that the increasingly interventionist approach of pharmaceutical companies, and, to a lesser extent, governments, is leaving researchers ham-strung and ethically compromised. The editors say researchers, not funders, must have control over the design of studies, access to raw data, free rein to interpret findings, and the choice to publish their results or not.
The editors are also demanding the right to review study protocols and funding contracts, documents that now often secret.
The new criteria mean that many studies touting new "miracle" drugs may be published in a credible peer-reviewed medical journal.
They also mean that findings that are critical of drug's performance, which are now routinely suppressed, would be published.
"By enforcing adherence to these revised requirements, we can, as editors, assure our readers that a meaningful and truly independent role in the study that bears their names.
"The authors can stand behind the published results, and so can," the editors write.
Their joint commentary is being published today in 13 journals, including the Canadian Medical Association, The Journal of the American Medical association, the New England Medical Journal of Medecine and the British Medical Journal, The Lancet.
The move was inspired by a number of clashes between scientists and drug companies, notably the case of Nancy Olivieri, a hematologist at Toronto's Hospital for Sick Children.
She and drug maker Apotex Inc. disagreed over the benefits and risks of the drug deferiprone: as a result, Apotex stopped funding Dr. Olivieri's trial, and that led to a protracted dispute in academic circles and the courts.
Yet, her case is no means unique.
Worldwide, pharmaceutical companies spend more than $40-billion (U.S.) annually on research and development.
With the cost of getting a new drug to market reaching as high as $500-million, economic pressures have overtaken the pursuit of intellectual rigour in studying new drugs and devices, the editors write.
"Many clinical trials are performed to facilitate regulatory approval of a device or drug rather than to test a specific novel scientific hypothesis," according to the commentary.
"The use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool."
Pharmaceutical companies argue that information about the efficacy and safety of drugs is proprietary, and they should ultimately decide what is published or not. The editors, for their part, argue that health research is a public good.
Dr. John Hoey, editor of the CMAJ, said this is particularly true in Canada where tax incentives and write-offs mean that about 70 per cent of research costs is indirectly supported by the public.
In a separate but related commentary in the Canadian Medical Association Journal, a group of leading academics has proposed a set of "rules" to govern industry-university research contracts in Canada. These rules would include a standard, Canada-wide contract governing university-industry relationships: guidelines that ensure new research should is of "sufficient intellectual originality," mandatory filling of all contracts with an overseeing body: the appointment of an ombudsperson to settle disputes: and a surtax on all university-industry contracts to fund oversight activities.
Titled Dancing With Porcupine, the article says academic researchers should not forswear all interactions with industry, but should exercise caution to ensure academic independence.
The paper notes that universities and teaching hospitals receive $161-million annually from industry, which spends another $900-million on in-house research and development.
"The duty of universities is to seek truth. The duty of pharmaceutical companies is to make money for heir shareholders. If either abandons its fundamental mission it ultimately fails. At times, institutional imperatives are bound to conflict," write the authors.
The authors include researcher Steven Lewis of the University of Calgary, Dr. Patricia Baird and Dr. Robert Evans of the University of British Colombia and Dr. Françoise Baylis od Dalhousie University in Halifax.
They argue that the tough new rules need to be adopted to ensure that university researchers do not become "handmaidens of industry" and to protect intellectual integrity of the process.
But above all, they stress that the current state of affairs is unacceptable.
"Some bargains are Faustian, and some horses are Trojan," they conclude. "Dance carefully with the porcupine, and know in advance the price of intimacy."
Quand une compagnie pharmaceutique commandite un congrès sur l'obésité. Quand une compagnie pharmaceutique met sur le marché canadien un anorexiogène, même, s'il était reconnue comme danger mortel depuis plusieurs mois avant. Quand une compagnie fait de la publicité indirecte pour vendre un produit amaigrissant qui n'a pas été reconnu comme vraiment efficace par le monde scientifique. Il nous est facile, après avoir lu cet article dans le Globe and Mail, qu'ils veulent s'accaparer de l'énorme marché des femmes complexées qui désirent perdre du poids à tout prix pour éliminer leurs rondeurs disgracieuses.
Le domaine de l'obésité ou de l'embonpoint est le plus douteux d'entre tous. L'industrie pharmaceutique sait très bien, que c'est le côté esthétique qui est payant! Pour cacher leur jeu, ils nous arrivent avec des arguments sur la santé. Ainsi, ils financent des recherches pour qu'elles arrivent à des conclusions qui dramatisent les facteurs de risques associés à l'embonpoint sur la santé. De plus, ils sont responsables des recherches qui disent que le nombre d'obèses augmente. C'est eux aussi qui ont lancé l'idée complètement farfelue que l'obésité serait épidémique.
En d'autres mots, la dramatisation de l'obésité est une stratégie de relation publique pour justifier les recherches qu'ils font pour trouver la pilule miracle qui rendra toutes les femmes minces, comme les vedettes d'Hollywood.
En conclusion, les femmes ont eu et elles auront toujours des rondeurs. Rien ne viendra changer ce fait immuable.
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