Medical journals set stricter rules for studies
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 are now often secret. The new criteria mean that many studies touting new "miracle" drugs may not be published in a credible peer-reviewed medical journal. They also mean that findings that are critical of a 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 the authors of an article have had a meaningful and truly independent role in the study that bears their names. "The authors can stand behind the published results, and so can we," the editors write. Their joint commentary is being published today in 13 journals, including the Canadian Medical Association Journal, The Journal of the American Medical Association, the New England Journal of Medicine 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 by 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 is of "sufficient intellectual originality;" mandatory filing 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 The 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 their 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 Columbia and Dr. Françoise Baylis of 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."
Sunday September 9 8:44 PM ET Scientists, Companies Clash Over Research WASHINGTON (Reuters) - The editors of the world's most prestigious medical journals unveiled a new policy on Sunday aimed at limiting the influence of pharmaceutical companies in research they fund involving their own products. Following are examples of some recent controversies. -- In 2000, scientists at the University of California at San Francisco (UCSF) acted against the wishes of Immune Response Corp., which had sponsored their research, and published a study that found that one of the firm's HIV (news - web sites) therapies did not help patients already getting standard treatment. The company then sued the university for allegedly hurting its business. -- Knoll Pharmaceutical Co. for seven years prevented the publication of a study it had funded conducted by UCSF clinical pharmacist Betty Dong that did not come to the conclusion it had wanted. The study found that the company's thyroid medication Synthroid was no more or less effective than less costly competitors. The company in 1999 agreed to pay 37 states more than $40 million to settle a lawsuit charging that it had impeded the publication of the study and made false claims about the superiority of its product. -- University of Toronto liver specialist Nancy Olivieri lost her research contract with Canadian firm Apotex Inc. after she defied the company and published in 1998 an article on research it had funded that called into question the safety and effectiveness of one of the company's drugs. The drug was for treating the blood disease thalassemia. The company maintains it dumped her contract because she did not follow the protocol it had devised for conducting the study not because of the results.
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