Ben Goldacre is a British author and academic who runs the Bad Science website. Bad Pharma is a systematic attack on the drug companies that put their profits above what is good for sick people, not only by selling them drugs they don't need, but by corrupting the whole scientific process meant to evaluate their products. You can get some of his basic ideas from his TED talk from September 2012. There are several fundamental problems in the process of evaluating drugs, but one of the central ones may not stem from intentional plotting by people concerned to maximize profit. It turns out that academic journals give preference to studies that give positive results for drugs, and are much less likely to publish negative results. So when reviewing the literature on a drug, it may be that many studies have been performed that show no advantage of the drug, while only a few studies shoe a positive result, yet only those positive results get published, and this leads to the false appearance that the drug is effective. The irresponsibility of the drug companies comes in when they trade on this feature of academic publication to fool agencies that approve the availability of medication to the public, and doctors who prescribe those medications. This is not a problem that occurs in rare cases: it is pervasive throughout the whole of medicine. It makes is almost impossible to be confident that any scientific information we have about the efficacy and safety of medications is in fact true. It undermines all confidence we have in pharmacological medicine.
That may sound like an alarmist conclusion, since we know that doctors prescribe medications that help withand even cure medical problems. That may be true, but it could not only turn out that some drugs we thought helped do not, and we may be spending a lot of money on new drugs that are no better than older cheaper drugs. Attempts to solve these problems such as ClinicalTrials.gov, in various jurisdictions have not so far worked, as Goldacre explains in some detail. He has himself collaborated in setting up alltrials.net, which has the aim of reporting all scientific trials that have been performed, but so far this is in very introductory stages. There is also the Cochrane Collaboration, which aims to collect the best evidence for the effectiveness of medications, but this too is far from complete. Goldacre is far from the first to point out the problem of missing data, but his documentation of the problem is alarming and the lack of solutions found is depressing. His work is easy to follow, and he documents his claims clearly, leaving little room for doubt that he has made a powerful case.
The rest of Bad Pharma follows up this central problem with more. Goldacre shows the problem of doing drug trials in the USA on people who work as professional guinea pigs. It is nearly always poor people who choose to go through this process, and they will cut whatever corners they can to get the money while enduring as little discomfort as possible. Then there is the problem of drug trials done in Third World and poor countries where it is very unclear whether ethical standards have been followed, and even if the drugs are effective, the population will not be able to afford to buy them.
Reading through Goldacre's book leaves one with little confidence that any new drug should be tried. The testing process for many drugs is very short compared to the length of time that many people in the real world end up using those medications, and the standards for approval of drugs are far from ideal. Even when problems with existing drugs emerge, it is very difficult to have them removed from the market unless there is dramatic press coverage of multiple deaths.
Even the trials that are reported can be misleading, because they are arranged so carefully in favor of the drug that the pharmaceutical company wants to promote that it really provides no useful information. It might be that a drug does have beneficial effects for a very narrow range of conditions, but when used outside of that range, it has no advantage and may even cause problems, yet the approval of the drug does not specify that it is for this narrow range. Another trick is to compare a low dose of a new drug with a high dose of an already approved treatment, and unsurprisingly the trials show that the new drug has fewer side effects than the old drug, but this is not a genuine finding about how the drug will work when it is used on real people. These sorts of problems just go on and on in Bad Pharma and readers will despair that there are any genuinely objective and fair assessment of drugs ever conducted.
The solution to many of these problems is to have better policy about what kinds of drug studies can be funded and restrictions on the ways that the drug companies can stipulate what studies are done. The influence of the drug companies needs to be reduced, and that means that financial ties need to be severed. In turn, this means that drug company advertising needs to be restricted. The USA is one of the few countries that permits direct-to-consumer advertising, and this advertising is problematic for many reasons which have been explored more fully elsewhere. Goldacre explores the influence of advertising on medical journals, and he argues that at a minimum, it should be possible for everyone to know how drug companies spend their money; the information should be public.
Of course, at this stage, we are used to revelations about the drug companies, and in truth, there are even more serious problems with the current medical system in the USA that the drug companies don't look so bad compared to other outrages. Nevertheless, Bad Pharma is an important book in keeping readers up to date on the extent to which the academic side of our health care system is broken, and gives patients plenty of reason to double check, triple check, and continue checking on information for medication they are taking. It puts patients in a difficult position, because the Internet is full of horror stories and promises of miracle cures, so doing research on any medical procedure will cause a great deal of anxiety. The fact that reliable and well-grounded information is extremely difficult to locate is disturbing, especially in a system that is massively expensive. The good news is that there are fairly obvious solutions to the problems that Goldacre lists: policy makers simply need the courage and persistence to enact those solutions.
© 2013 Christian Perring
Christian Perring, Professor of Philosophy, Dowling College, New York