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Newswise — A new study from the University of Virginia Health System has found that academic researchers who are highly reliant on industry support are most likely to have experienced questionable pressure from sponsors and to have first-hand knowledge of integrity breeches within their work environment. Those breeches not only compromise the well-being of medical research participants but also impact research initiatives, publication of results, interpretation of research data and scientific advancement.
Most prevalent forms of industry support - Sixty-six percent of respondents reported receiving industry support, the most prevalent forms of which were: research contracts or grants, honoraria, biomaterials, trips to professional meetings, support for staff or study coordinators, support for students or fellows, discretionary funds or gifts to the researcher’s institution, equipment, funds for publication costs and personal gifts of more than $100.
Questionable requests from industry sponsors – A minority of the 231 respondents funded by industry reported receiving questionable requests from their sponsors – 13 percent were asked to delay publication of research; nearly 8 percent were asked to tailor presentations to favor a sponsor’s drug or product; 7 percent were asked to keep their research secret; and 4 percent were asked to withhold results from publication.
In a study that will likely change medical practice, researchers reported that Crestor, a cholesterol-fighting statin made by AstraZeneca (AZN), reduced the risk of heart attack, stroke, and cardiovascular disease by a surprisingly robust 45% in people who do not have high cholesterol. The patients did have high levels of a protein associated with arterial inflammation that is not routinely measured.
Medical experts said the results, released Nov. 9 at the American Heart Association (AHA) meeting in New Orleans, will almost certainly expand the market for statins, already the world's best-selling drugs. They also will likely spark demand for a controversial and costly test for high-sensitivity C-reactive protein (CRP), a marker for inflammation, which has some practitioners worried about the cost/benefit of extrapolating the research to the general population.
A systematic review2 found 30 studies investigating whether industry funding is associated with outcomes that favour the funder: studies sponsored by drug companies were more than four times as likely to have outcomes favouring the funder, compared with studies with other sponsors.
How does this systematic bias come about? One answer is questionable trial design. Studies are conducted, for example, where the competitor drug is given at an inadequate dose, or worse, at a higher dose, increasing the risk of side effects, and so making the sponsor’s drug appear to be preferable.3
Another common problem is that the industry can choose which data to publish, and which to leave unavailable. Much has been written on eye-catching stories, such as the difficulties in getting clear information about the number of suicide attempts in industry trials of SSRI antidepressants4 or the number of heart attacks in patients on rofecoxib (Vioxx).5
In medicine, bad information leads to bad decisions: we prescribe one drug where an alternative would have been more effective, or had fewer side effects; or we prescribe an expensive drug, unnecessarily, when a cheaper alternative was equally effective, and so we deprive the community of limited healthcare resources. This is dangerous and absurd. Doctors who are making treatment decisions need access to good quality trial data, presented transparently, and all of it, not just the positive findings that drug companies choose to share.
When weighing the results of a medical study it's important to consider who supplied money to conduct the research. According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry.
Researchers reviewed 546 drug trials and found that industry-funded trials reported positive outcomes 85% of the time compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations. Among the nonprofit or non-federal studies, those that received industry contributions were more likely to be positive (85%) compared with those that did not have any industry support (61%).