Bad pharma, good pharma: an insider’s view
pharmafile | May 30, 2013 | Feature | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | ABPI, Bad pharma, Goldacre, NICE, transparancy
Most people in the pharmaceutical industry, particularly in the UK, will be well-acquainted with Ben Goldacre by now.
He published his Bad Pharma book in September 2012, and since then has managed to attract (some might say court) huge media attention for his message, that “drug companies mislead doctors and harm patients”.
One interesting point is that while most people in the industry will be aware of Goldacre’s book, not many have actually read Bad Pharma in full. I myself have only recently finished reading this 400-page tome, and I’ve have met many who mean to read it or have dipped into it. I read it from cover to cover, though not in one sitting.
So is Goldacre peddling a distorted, one-sided view, or has he really got a point that we should be paying attention to? Is he Jack the Giant Slayer, or just a Don Quixote figure, tilting at windmills?
In his lengthy and detailed book, he paints a number of bête-noire scenarios, covering missing trial data, clinical trials designed to produce positive results, and many marketing transgressions. Regulators are also accused of being complicit or ineffective in spotting these problems.
I would bet that if you know these topics, you would probably have to admit that some of it seems horribly familiar. But that doesn’t mean that Goldacre has it all right and the industry has it all wrong.
Goldacre’s training
According to Wikipedia, Ben is a 39-year-old doctor (psychiatrist) and scientist (he is well qualified) who is a writer and research fellow in epidemiology. What you may not know is that his mother is Noosha Fox, who was lead singer with a band called Fox during the early 1970s, and frequently seen on Top of the Pops for a short period.
His knowledge of psychiatry comes out in his writing, and many examples he uses in Bad Pharma come from this field – here may be one of the intrinsic weaknesses of some of his ideas.
If you did not know, the basic premise of Bad Pharma is that drug companies mislead doctors and harm patients. Without saying as much, the corollary is that because pharma is involved with the well-being of patients, it has no need to see itself as a business, and should always act in the most altruistic fashion.
It is not until about 300 pages into the book that Ben mentions that the pharmaceutical business is an industry and exists to make a profit. Furthermore – and I know you know you are doing this every day – the industry sells its products on the basis of questionable or missing data, dubious marketing practices… and a conspiracy not only with prescribers but the august professional bodies that are supposed to maintain standards of practice.
In fact it would be easy to come away from reading this tome thinking that there was not one worthwhile innovation that industry had produced, and if illness is cured or prevented, it is more by good luck than by planning.
Whilst it might sound boring (and I would guess the average lay reader may stumble here), a large part of the work is taken up with a discussion of bad (clinical) trials and bigger simpler trial. He focuses on a substantial number of studies in the public and not so public domain, and pulls them apart.
I have to say that he has chosen his examples well, and it is a pity that there is so much ammunition available for him. But most of his experience and knowledge is in psychiatry, and one of the annoying things about psychiatry is there is often nothing physical that you can measure in a study. It is not like cardiovascular, where you have the simple endpoint of alive or dead.
Madness is a widely variable state and one man’s mad is another’s inspired genius. There is a lot of reliance on rating scales and scoring systems, and even in the best validated system, there is a degree of human variability.
It’s a sad fact that actually the majority of ‘good’ studies are actually arranged and sponsored by industry: why would they not be? Conversely, in my experience there are buckets of studies arranged by academics that end up as a load of hog-wash.
At least industry studies these days are subject to lots and lots of oversight, audits, ethical committees and adequate resources. They have to be because the drug regulators don’t like it if you offer something that is obviously slack.
What Goldacre ignores is that the journals are populated by clinical studies that were investigator-led, were methodologically flawed from the moment the first note went down on the back of a used envelope, have indeterminate results and may have used investigational interventions of dubious quality.
One of the bluest pieces of blue-sky thinking in the book, in my opinion, is that the results of all studies should be in the public domain so that anyone can analyse the data to confirm the outcomes.
The ABPI seems to be showing signs of succumbing to the principles of the ‘All Trials’ campaign (Alltrials.net), so that the summary trial information will be published for all trials. I don’t know if this will achieve anything at all, as the devil is usually in the detail.
Goldacre has clearly never worked in an environment where your competitors would sacrifice their unborn children to get their hands on the raw information from a pivotal registration study, and dissect everything looking for the one ‘glaring’ fault that would end in a code of practice confrontation or worse.
My colleagues in clinical tell me that data are an asset to be guarded, and no wonder that protocols most often state that the results are the property of the sponsor.
The cost of Phase III studies beggars belief, and it is difficult to understand how any sponsor company would want to immediately surrender the information in the pretence that transparency is being served. I even heard of one Phase I unit that went into administration, and the receivers tried to sell a company its own data to mitigate the debts.
From bitter experience we learn that however well industry studies are designed, conducted and analysed, there will always be detractors saying: “Why didn’t you do it this way?”, or “I don’t understand why you had difficulty in finding enough patients.” If you ever sit in a NICE meeting, or meet with drug regulators you will comprehend the potential complexities of study data.
I can wildly speculate that one of the mission statements of NICE is to examine data with the express purpose of weakening the arguments of cost benefit of expensive treatments. Whilst it is admitted that there have been one or two stinkers, by and large, industry studies produce valuable data, and to offer it up as a sacrifice to political correctness just doesn’t make sense.
Insight on regulators
From the chapter entitled bad regulators, it’s obvious that Ben has not had to spend much time with the drug regulators. If the regulators are so lax, and so bad, how come it takes so much time and effort to satisfy them?
We have spent much time with the regulators over the years, and whilst there are some complete ‘jobsworths’ in the various agencies, there are some pretty smart cookies that can spot a dud at a thousand metres. Because they are civil servants, there are no prizes for taking chances, in fact quite the opposite.
But there is no easy answer to the drug approval process, as it is inevitable that approval or lack of approval must be based on a limited amount of information so as to make the process practical.
It is accepted that sometimes the balance of risk and benefit is not fully understood on the date of positive opinion, but approvals are not set in stone, and if the risks are seen to change, you can bet the agencies are way ahead of you in the game.
It actually is appropriate to mention that at the time of writing, a class of new diabetes drugs, the glucagon-like peptide-1-based therapies are under scrutiny as a cause of iatrogenic pancreatitis. Whilst the article in the BMJ may have been news to some, the EMA had been watching the signal for ages, and they will surely move on this apparent class effect.
Goldacre spends a lot of time pondering the issues surrounding rosiglitazone, and whilst some might argue that the authorisation holder spent too much time fighting a rearguard action, what is not mentioned in the book (again in a BMJ analysis) was that the approval was influenced in the first place by political pressure to have managements for diabetes, and key opinion leaders lobbying the regulators.
Conspiracy theory
That brings us to another issue: is there a conspiracy between the medical professions and the pharmaceutical industry? In a Goldacre world, no one would attend a meeting that was sponsored, or a meeting where a speaker advocated a branded prescription medicine, nor let a crumb or drop cross their lips which had not been paid for out of their own pockets.
Medical students would be taught that only generic medicines were survivors providing their systematic reviews were supportive. The uncomfortable fact is, as I was reminded by healthcare consultant Richard Driscoll, most postgraduate education (which doctors have to systematically collect and document for their re-licensing exercise) is provided or subsidised (even if it is only a cheese sandwich) by the pharmaceutical industry.
I know very few doctors who turn down a free lunch. To suggest that the continuing medical education should be provided independently is wishful thinking, and whilst it might just be possible to change a culture so that doctors are expected to pay the free market cost for their own education it probably might not happen in my lifetime.
Then again, stranger things have happened. The other viewpoint is that if doctors attend enough company sponsored events from different companies, they will be exposed to an all-round view, so the bias will be factored out. Incidentally, I came across a case recently when a colleague, in a moment of anger, applied for CME accreditation for a meeting from a learned college.
He deliberately indicated that one of the speakers intended to give a presentation which clearly created a conflict of interest because it was related to a sponsor company’s products. After receiving the moderate fee for registering the meeting, the CME credits were granted quickly and without any questions asked. So healthcare professionals must be kept up-to-date, and someone has to pay for it.
A fresh perspective
Whilst I may have felt transient anger and impotent frustration whilst I navigated through Ben’s naughty list, there was actually one unexpected side effect. After finishing the book, and picking up where I left off, I actually found I was looking more critically at the work of my colleagues, and asking myself whether maybe there is a better way of doing what we are doing.
One thing I liked was the attempt to try and offer a lay explanation for some of the terms and methods used frequently in our work, such as: “What exactly is a 95% confidence interval?”, and how many patients does it need to give an idea of safety (page 152 for an explanation of the rule of three, which still baffles me a bit).
It may be a matter of raising the internal bar so that what we do is less vulnerable to criticism if it is scrutinised, or it may be that there are areas where transparency might actually do some good for everyone.
I personally think there aren’t any easy answers here – however, a simplistic ‘pull the blanket up’ approach to uncovering misdemeanours will certainly not solve the problem.
Brad Abbey is the pseudonym of an experienced pharmaceutical industry executive
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