It may seem to the casual observer that the U.K.’s Great Oxford Debate (held in September at Oxford University and covered last month in the British Medical Journal) resembled a fight between the fox and the farmer over which one of them should be in charge of the henhouse. In one corner, wearing the red silk shorts, you had physician, activist and Bad Science blogger Dr. Ben Goldacre, who argues that the financial interests of a drug company lead to distorted clinical evidence when they run research trials on their own drugs. In this corner, in the shiny blue Spandex, you had consultant Vincent Lawton, a Big Pharma veteran (most notably as a 26-year executive with drug giant Merck Pharmaceuticals), arguing that adequate safeguards already exist to keep a drug company’s research bias nicely in check.
With the British Medical Journal refereeing the rumble, let’s tune in for Round One, led off by Vincent Lawton:
“The drug industry is sometimes accused of finding it difficult to reconcile the difference between the strict disciplines of ethical science and its responsibility to its shareholders to return a healthy profit. But clinical trials are properly managed by a rigorous system of regulatory scrutiny throughout.” VL
Sounds convincing to me, but wait! Dr. Ben fires back with a combination punch to the breadbasket:
“The practice of medicine is based on evidence. We need this evidence base to be complete and of the highest quality, so that we can make the right decisions. But drug companies produce most of the evidence we use. There is no doubt that these companies have a conflict of interest when they conduct drug trials: they want to sell their products, and so naturally theymwant a positive result from the trials they sponsor. But there is now good evidence from systematic reviews, meta-analyses, and case studies that this conflict of interest results in bad evidence, which distorts medical decision-making and so harms patients.” BG
Good power punch, Dr. Ben – but Vincent is not yet ready to kiss the canvas:
“The drug industry develops medicines through years of painstaking research by some of the best scientists in the world, often in collaboration with academic researchers. Clinical trials are an essential part of developing safe and effective drugs, and after the drug is introduced to clinical use, more is discovered about its effects. Further trials, which can also involve academic collaboration, are done to provide further information and to study whether new indications can be added to the drug’s use.” VL
So apparently we already have a solid team approach working here between the best scientists in the world and independent academia – except Dr. Ben is now about to steal the round:
“We know that studies sponsored by drug companies are more than four times as likely to have outcomes favouring the funder’s drug, compared to 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.” BG
What kind of trash talk is that? Vincent, explain that standing eight!
“Having invested an average of $1.2 billion and 10 years to bring a medicine to the market, is the drug industry expected to surrender its intellectual property? A third party’s lack of infrastructure, expertise, and resources would inevitably lead to delays, cutting into patient access and the patent life of the medicine. This seems to be a sure way to drive away any incentive to innovate.
“About 75% of the funding for clinical trials in North America now comes from the drug industry. The better way for patients, health care, and innovation is to continuously improve what we have, despite potential competing interests.” VL
Well, Vincent clinches a good point: who’s going to pay for 75% of all clinical trials if you pull Big Pharma out of its current funding role? But Dr. Ben’s back on his feet to go the distance:
“A common problem is that the industry can choose which data to publish, and which to leave unavailable. Look at the difficulties in getting clear information about the number of suicide attempts in industry trials of SSRI antidepressants, or the number of heart attacks in patients on Vioxx. Not to mention the routine grind of publication bias, where disappointing negative results on the benefits of treatments quietly disappear.
“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. We prescribe an expensive drug, unnecessarily, when a cheaper alternative was equally effective, and so we deprive the community of limited health care resources.
“This is dangerous and absurd. Doctors who are making treatment decisions need access to ALL good quality trial data, presented transparently, not just the positive findings that drug companies choose to share.” BG
Was this a split draw? Read the British Medical Journal’s account of Dr. Ben Goldacre’s position demanding that drug companies cannot be trusted to conduct the research trials they pay for. And then read Vincent Lawton’s position insisting that the drug industry already provides appropriate safeguardsof transparency, scientific integrity, and regulation.
What do you think?