Can we believe the published results of studies sponsored by drug companies? Or is the financial conflict-of-interest behind those studies so great that it produces distorted evidence — distortions that lead to medical decisions that harm patients?
As far as I’m concerned, Goldacre delivers the knockout arguments. He does it by presenting some devastating evidence, such as the results of a large meta-analysis of studies conducted on non-steroidal anti-inflammatory drugs (NSAIDs):
[The analysis] found all the studies that had ever been published where one NSAID was compared to another. In every single trial, the sponsoring company’s drug was either equivalent to, or better than, the drug it was compared to: All the drugs were better than all the other drugs. Such a result is plainly impossible.
Another review cited by Goldacre looked at 30 industry-funded studies and found that “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 occur? “One answer is questionable trial design,” says Goldacre. “Studies are conducted, for example, where the competitor drug is given at an inadequate dose, or worse, at a higher does, increasing the risk of side effects, and so making the sponsor’s drug appear to be preferable.”
Goldacre also describes how companies pick and choose which data to publish — and which to make sure never sees the light of day. The companies make sure that disappointing results remain unpublished while positive results are published repeatedly, but in ways that are difficult to spot.
The success of these efforts is “staggering,” says Goldacre.
Ramsey and Scoggins went to clinicaltrials.gov and found all the trials on cancer: 2028 in total. Only 17.6% of these trials could be found published on PubMed, but 64% of those that were published reported positive results. Restricting their analysis to only industry sponsored trials, these results became even more extreme: just 5.9% were on PubMed, but of those trials, 75.0% gave positive results.
These kinds of shenanigans can lead doctors (and information-seeking patients) to believe a drug is better than it is, says Goldacre.
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.
Lawton’s response? He argues that there are already plenty of regulations in place to ensure good studies, that studies sponsored by noncommercial interests can also be substandard, and that the pharmaceutical industry has developed “various transparency measures” with the input of regulators and the academic community.
(Hmmm. … No mention of the scandals involving academic researchers’ conflicts of interests with drug and medical device makers. Nor does he mention questionable ties that have arisen in the past between government regulators and the pharmaceutical industry. )
Lawton also points out how expensive it is for drug companies to bring a new product to market (an average of $1.2 billion per drug, he says), and if companies were compelled to surrender their intellectual property (aka, details of their studies), drug innovation would essentially come to a halt.
“This seems to be a sure way to drive away the incentive to innovate,” he says. “At present about 75% of the funding for clinical trials in the United States come from industry and total industry spending on research is greater than that of the National Institutes of Health.”
Maybe I’m missing something, but what’s the point of that argument if the results of those trials can’t be trusted?
You can read the arguments of both Goldacre and Lawton in full at the BMJ website. The two men also argued this topic at the PharmaTimes Great Oxford Debate last August.I’ve made a cursory search, but I haven’t been able to find a video or podcast of the event. If any MinnPost reader can locate one, please send me an email and I’ll put up the link.