More important IMO is Data Transparency. If this is handled then less worry about these doctor payments if it means a bit of a break on the promotion of drugs with questionable benefits, from
Missing Data
Goldacre starts with missing data, the basis of his thesis and one of the most fundamental problems in medicine today. As I noted in a
recent post on on clinical trials transparency, missing data compromises our evaluation of the evidence base, prevents science-based care, wastes resources, and ultimately, does a disservice to patients. If trials are conducted that don’t support efficacy claims, yet are never published, the evidence base becomes biased in favor of treatments and interventions. Goldacre
summed up the issue concisely in a recent interview in
The Economist:
If I were to run a study, and then just remove half of my data points so that my results looked much better, well, you would laugh in my face. It would be obvious to anyone that it was research misconduct. You might even call it fraud. And yet we tolerate the results of entire clinical trials—a huge proportion of them—being withheld from doctors and patients. In medicine, we rely on summaries of evidence, we collate the results from many different trials. So withholding the results of whole trials is exactly the same insult to the data as fraudulently deleting data points from within individual studies.
There is ample evidence that the evidence base we are currently using in medicine is distorted exactly as Goldacre describes. However, the extent to which this has harmed our treatment evaluations is probably impossible to discern. Goldacre points out that this isn’t just pharma’s fault – research ethics boards, universities, regulators, and medical journals have all failed to follow-through on new standards for data transparency and access. Goldacre calls these “fake fixes”, such as the requirement from the world’s top medical journals to ensure that all published trials are registered before they commence – but the requirement isn’t subsequently enforced. These fake fixes extend to regulators who offer lip service on transparency, and even block access to the evidence they have used to determine if a drug should be approved for sale. Instead there is a “yes” or “no” decision, with little public sharing of the evaluation process and information considered. Goldacre makes an important point about regulatory decisions versus those made by health care professionals:
Contrary to what some regulators seem to think, a drugs is not either ‘good’ and therefore on the market or ‘bad’ and off it. A regulator makes a decision about whether it’s in the interests of the population as a whole that the drug should be available for use, at all ever – even if only is some very obscure circumstance, infrequently and cautiously. The bar is set pretty low, as we shall see, and lots of drugs that are on the market (in fact, the overwhelming majority) are hardly ever used.
A doctor needs to use the same information as that available to the regulator in order to make a very different decision: is this the right drug for the patient in front of me right now? The simple fact that a drug is approved for prescription doesn’t mean it’s particularly good, or the best. In fact, there are complex decisions to be made in each clinical situation about which drug is best.
Goldacre concludes the chapter with an extended list of fixes, outlining ways to strengthen the checks and balances to ensure that the results of all human trials are made publicly available. Some are major policy issues, others are much more simple to implement. Would they improve transparency? Undoubtedly. Are these new issues? No. But the culture of complacency that exists in the health care system about this issue has so far been remarkably resistant to meaningful change.
