My book Bad Pharma documents serious ongoing problems in the pharmaceutical industry. In particular, I show how vitally important information from clinical trials is still being withheld from doctors and patients, right now, today; and that patients experience avoidable suffering and death as a consequence. There is no nicer way to express that reality, and this ongoing problem of missing data is meticulously documented in the book, because it is widely discussed in the medical literature.
I am very sorry to say that the ABPI, the UK pharmaceutical industry PR group, has now responded, and their only response has been to flatly deny what is plainly and provably true. Here is their press release, titled “ABPI statement on Ben Goldacre’s book Bad Pharma”. Most of it explains that drug companies are great. Only one paragraph addresses the serious concerns I have raised:
“The issues presented in Ben Goldacre’s book Bad Pharma are important. They impact on society’s ability to deliver innovative medicines to solve areas of unmet clinical need and improve the quality of lives for countless patients and their carers. We must remember though that the examples he refers to are long documented and historical, and the companies concerned have long addressed these issues.”
This is simply not true. The examples I refer to – Tamiflu, the failure of clinicaltrials.gov, and more – are contemporary, and very much ongoing. They are set out in plain English in the very first chapter of the book. It is extraordinary and bizarre that anyone should claim that these problems are historical.
The ongoing story of Roche withholding vitally important information on the risks and benefits of Tamiflu is just one illustration, but it is meticulously documented, and a good account can be found in this open access journal article. Here is the BMJ’s ongoing Open Data campaign page on Tamiflu. There is absolutely no sense in which this ongoing scandal is historical or resolved: Roche continues, today, to withhold this information from doctors and patients. For this, Roche should be publicly criticised by the ABPI. At the very least, one might expect the ABPI to remain silent. Instead, the ABPI claims that these problems are historical and have been fixed. This is an extraordinary and demonstrably false claim.
Tamiflu is just one example. The most current systematic review on “publication bias” – the phenomenon whereby trials go missing in action – can be found here. It shows that overall, around half of all the trials that are conducted and completed go unpublished, and that trials with “positive” or flattering results are about twice as likely to be published as trials with negative results.
This is an ongoing problem, and as a result, we cannot know the true effects of the treatments we use in medicine. Various things have been done to try and address this issue. All these solutions have been announced with fanfare, and they are always lauded as if they have been successful. In reality, all of these interventions have failed.
In 2004, we saw a charade, as the academic journal editors claimed that they would hold the line, by forcing all companies and researchers to post their trials on a trials registry: in reality, as we discovered in 2009, the journals had repeatedly broken their promise. The problem persisted.
In 2007, the US government passed a law stating that all trial results must be posted on clinicaltrials.gov within one year of completion. Everybody announced that the problem was fixed, once again. But in 2012, an audit was finally published, which showed that only one in five trials had met this reporting requirement. Despite this astonishingly bad performance, no fine has ever been levied against any company or researcher for failing to post results. Even if a fine had been levied, it is only $10,000 a day, or $3.65m a year: a parking ticket to a company with annual revenue in the tens of billions.
Finally, even if these initiatives suddenly became successful tomorrow, that would still not solve the problem. We do not practice medicine using only the results of trials that were completed after October 2012: we use drugs from 2009, 2003, and 1998, from an era when we know the entire evidence base for medicine was hopelessly distorted, by companies withholding vitally important trial data. We need all of this trial data to be released, urgently, today, to prevent ongoing harm to patients.
There is absolutely no doubt whatsoever that unflattering trial data continues to be withheld from doctors and the public, and there is absolutely no doubt that patients suffer as a result. Even more tragically, as I show in the book, doctors, academics, regulators, journals, patient associations, and universities have all failed to adequately address these problems, behind closed doors, over the course of many years.
I believe that if patients and the public ever come to realise what has happened, then they will demand change. I believe that the Royal Colleges, patient associations, universities and ethics committees must do more to protect the interest of patients, by demanding that all trial results are published in full. That is why I am working to give the public the clearest possible explanation of what has gone wrong in medicine, and to set out several simple steps that would start to put these problems right.
I have taken the liberty of drafting what I believe the ABPI should have said, in response to my book, if they were sincere about engaging on this vitally important issue. I hope that they will reconsider their position, and engage more constructively on what is undoubtedly the most important ethical problem facing medicine today.
The ABPI’s outright denial, of ongoing problems that are so well documented, is worrying, because it hints at a wider malaise: that the pharmaceutical industry has learned there are no consequences for claiming black is white. As long as we live in a world where the ABPI can feel confident about claiming, quite falsely, in the face of all the published evidence, that these problems are in the past, then patients will continue to suffer unnecessary and avoidable harm. I truly wish this wasn’t so.
What I believe the ABPI should have said:
“We are pleased to see that Ben Goldacre’s book recognises the valuable contribution made to drug development by the pharmaceutical industry, and that our members are not motivated by evil intentions. We also recognise, though, that much harm has been done by unethical activity in our industry, however unintentional; and that the evidence clearly shows these problems are ongoing.
“Despite some international effort over the past two decades, many trial results continue to be left unpublished. This undoubtedly misleads doctors and harms patients, and this issue must be addressed. Members of the ABPI must continue to work harder to strengthen international legislation, and we call on the industry to ensure that all information about trials is shared with clinicians, academics, and patients. In particular we condemn Roche for continuing to withhold information on Tamiflu from Cochrane, though this is not an isolated incident.
“Lastly, we recognise that the harm done to patients by withheld trial results cannot be adequately addressed by ensuring only that future trials are fully published. Patients continue to be put at risk by the withholding of trial results over the past decades. Fixing this will not be easy. But we are committed to encouraging industry to cooperate fully with an amnesty on all previously withheld trial results.
“This will not be easy, and of course the industry is not all bad: this can be seen in the lifesaving products produced across all disease areas. But we strive to improve.”
I am sorry to say that tomorrow I will be sharing another, much more troubling response to the book, from a different organisation.