Don't read Ben Goldacre's `Bad Pharma' without also reading the references I cite below and looking at a live example scientific discussion on-line between some top medical science researchers, the link for which I will also give you. This will add some balance to the situation. And to my fellow Amazon reviewers, feel free to reconsider your thoughts after doing the same. I don't know about `Bad Pharma' but this is a bad book. The author has written an extremely unbalanced, negatively biased and moreover retrospective and in some respects out of date account of selective situations that have occurred in the pharmaceutical industry over the last 20 years or so. You could select pretty much any industry or organisation over the same period such as in politics, banks, tax evasion, the media, police and the legal profession and dig up some scandals, but to what constructive purpose? Consider over that same 20 years, while all the malpractice and corruption the author catalogues in this book was occurring, we have become a healthier species worldwide in 2012, suffering less pain and living longer than ever before in human history. The author talks about deaths occurring as a result of trial data being withheld; but overwhelmingly the balance sheet is actually millions of lives saved and moreover quality of lives improved. This progress in medicine is in no small measure due to the efforts and research of the pharmaceutical industry which the author so disparages in this book. How can we square these two views?
During the reading of this book it seemed to me that Dr Goldacre has a patently unhealthy attitude against the pharma industry which informs almost every word he writes; I can't help wondering how this arose. We now have antibiotics to control infection, vaccines to prevent infection, treatments for blood pressure and lipid profiles to reduce cardiovascular risk, oncology products for cancer treatment and pain relief at the end of life; HIV sufferers with the aid of medicines now live with their disease for much longer; diabetics are so much better controlled with fewer long term complications; couples can control the size and timing of their families; post-menopausal ladies suffer far fewer fractures nowadays with modern drug treatment. None of these medicines would be available to doctors without the efforts of the pharma industry. Today, the pharma industry is far better regulated than ever before, this continues year by year to update its codes of practice and still provides the best model for medicines research going forward despite the cases cited in this damaging book. The author asserts that `medicine is broken'; it is not. And I absolutely disagree with Max Pemberton's newspaper review whose only criticism of this book was its length - a shamefully uninformed review in a national newspaper from someone who appears to have little understanding of the pharmaceutical industry.
I find only one redeeming paragraph in the whole book in which the author acknowledges that the pharmaceutical industry has done some good, as if to mitigate himself. Otherwise this book is a damaging slur on an industry and also on the medical profession to which the author himself belongs, which have together been instrumental in improving the health of the world, for the last 50 years or more.
It is absolutely essential to have strong links and close cooperation between drug companies and doctors to enable patients to benefit from the best of these medicines we have at our disposal. But Dr Goldacre paradoxically and subversively, goes as far as to suggest a severing of links between medicine and the drug companies which have researched and provided us with these medicines; a form of medical masochism. He himself refuses to see drug company reps; as if cutting off his nose to spite his face. Yes, these links need to be strongly regulated and they have been abused in the past by some; but a free flow of information and data between pharma and medical practice should be absolutely sacrosanct and uninterrupted. The author would cut these links altogether in his brave new world; this would be an absolute nonsense and counterproductive in our continuing search for new and better medicines. The author seems not to have caught up with the industry in this respect which largely now doesn't actually employ reps; the current model is the use of Medical Scientific Liaison officers (MSLs) who's function is more educative than just selling. MSLs provide this important link and provide information to the medical profession about current products. My advice to the author if he still practices medicine in between writing books, is to give these MSLs his time (no more than a single patient would take), from as many companies as possible and in so doing educate himself into what's new, interrogate these folk about the data and then make up his own mind what to prescribe, balanced with his own research. No-one is forcing him to write a prescription nor should he expect any payment for doing so. These days it is quite absurd to suggest that any MSL or rep would behave like that, moreover, ever access patients' data, one of his other complaints. This may have happened in the past on occasion but would never happen now in our more and continuingly highly regulated environment.
One omission in this book is that the author doesn't describe the structure of pharma companies in the UK with respect to promotional and non-promotional sections - this is actually quite important. Although this is not exactly replicated worldwide, there are two halves in all UK pharma companies; the promotional, marketing department; the other, Medical Affairs (along with Regulatory Affairs and Pharmacovigilance) which perform a non-promotional scientific service to the marketing department and also to external customers like you and me. This is to ensure accuracy, fairness and balance to all materials about drugs before they are released. If Dr Goldacre found himself in the role of a Medical Advisor, now in 2012 in one of the UK pharma companies, his day would be taken up ensuring the scientific accuracy of marketing materials and the data therein and furthermore compliance (and that of his staff) to the ABPI Code of Practice (referenced below FYI). This would be so very far from the malpractice he claims has occurred in the past. He would also scrutinise other companies' promotional material for accuracy as part of his remit and complain to them and if necessary the regulator (PMCPA), if there was any inaccuracy. He would also be asked to give, and moreover defend, data presentations on products and therapeutic areas to his peers in hospitals, to fellow doctors, (and of course be interrogated by them) and train the MSLs to do likewise. Such information presentation is and should remain an important part of the link between industry and medicine. The author of this book would remove this activity. Doctors are no fools and at the end of the day it is they who write the prescriptions for medicines not the drug companies. The author claims to have evidence of widespread bribery and corruption that doctors who have taken the Hippocratic oath are somehow persuaded against their better judgement to write prescriptions under the influence of drug company reps and money. This is just nonsense nowadays.
Bad behaviour may have occurred in the pharma industry in the past, and Dr Goldacre presents isolated cases to support this, but I would suggest that it is no more and no less than similar behaviour in other industries; banks and fixing the Libor rate; jailed financial stock market traders gambling away their banks' millions; phone hacking of murdered schoolgirls by the newspaper industry - the Leverson enquiry; price fixing between supermarkets; UK MPs falsely claiming tens of thousands on expenses; I'm sure you can think of others. It is a sad truth that in our Western democracy where there is competition between organisations there will always be rogues out to cheat, whatever the industry. Of course none of this behaviour can ever be justified or exonerated. But as Winston Churchill said of democracy, it is the best system we have until someone comes up with something better. Dr Goldacre's solution for medicine and the pharma industry is not better. He would subvert the existing system and encourage whistleblowing. As a matter of fact whistleblowing is already encouraged internally by most ethical pharma companies today. The author's suggestion is already in place. No Dr Goldacre, the answer instead is to continue with increased regulation, as is currently already happening, in the existing hugely successful model.
The author talks a lot about data from pharma-sponsored drug trials being selectively published; about withheld data, patients dying as a result and about money changing hands from pharma to doctors for their advice and authorship. These events may have occurred but you must put this into the context of our vastly improved health and longevity. Dr Goldacre asserts that patients have died as a result of a lack of data transparency and publication. But overwhelmingly, if indeed this is true, balance this with the massive benefits we now enjoy. That doesn't excuse withholding relevant data from trials of course and patients in trials do sadly die from their disease; but the link between withheld data and patients dying is highly dubious. Transparency in trial data is increasing all the time as regulation of trials improves.
Not all research in any field is published - this is normal - and there are lots of reasons why not. But the author suspects deliberate pre-conceived malpractice against patients' interests, whereas lack of data transparency is more likely to be a competitive intelligence issue. Provided patients interests are not compromised, we live in a world of commerce in which the Western `pharma-medicine' model has evolved. Unless you are advocating an anti-Capitalist, Marxist society and protesting in a tent outside St Paul's cathedral, this is where we are now, like it or not. As regards other malpractices surrounding professional advice and co-authorship, just consider that if you yourself were asked for your legitimate professional advice or authorship services you`d expect to be paid the going rate for it wouldn't you? It's hardly credible furthermore that principle researchers and authors don't proof-read before publication of trial results, another one of the author's claims.
The author points out that some trials never reach their planned end-points but are stopped early, again implying malpractice. If drug trials are stopped it may be for a variety of legitimate efficacy or safety reasons. It may be that the trial drug is shown to perform so well that it would be unethical not to offer it to the placebo group (as happened in the Jupiter trial of rosuvastatin) or that the drug was found not to offer any benefit over comparator or placebo during the trial. Dr Goldacre also expressed surprise that data was looked at during the progress of such trials; however it is absolutely essential for a panel to monitor results of a trial during its progress to examine efficacy data and side effects. If side effects are unexpectedly high this would be another good reason for stopping a trial before its planned completion point. There might be between hundreds and up to tens of thousands of subjects in a pre-marketing trial (ie. a trial conducted before a licence is granted by the MHRA (the independent UK regulatory body)). For example in the `HPS-2 THRIVE' trial, the results of which were recently summarised, 25,000 patients were recruited worldwide; this is considered a `large' trial.
However it is only when a drug comes to market after a drug is given its licence, that patient exposure reaches millions of patient-years and very rare events (called `signals') may be observed (remember thalidomide?). Drugs can be subsequently withdrawn or their licence modified, post-marketing, under the scrutiny of the MHRA under these circumstances. This whole pharmacovigilance effort continues daily after a drug comes to market and for all drugs. The author's obsession with early pre-marketing trials therefore, is misplaced. The proof of the pudding is in the post-marketing eating; it is this real life efficacy data which will more accurately reveal the value of the drug and its safety from side-effects, more so than even the larger pre-marketing trials which Dr Goldacre focuses on. Ironically the HPS-2 THRIVE trial over the four years it ran, failed to show the cardiovascular outcomes benefits which had been expected, despite the drug (a niacin compound) being known to increase your `good' cholesterol. Remember also this was after many millions of dollars had been invested in its development over many years before the trial even started, money never to be recovered. This also lays waste to the author's claim that negative results are not published - they clearly are, even when the results are clinically disappointing.
Here are the references you should read if you are considering reading this book. For each of the points 1 - 4 below, preface the web site URL below with 'www.'
1. pmcpa.org.uk Search for the `ABPI Code of Practice for the pharmaceutical industry' and download it. Compliance with this is continuous within pharma companies and tested in all employees.
2. mhra.gov.uk Search for the `Blue Guide' and download it; a guide to ethical marketing principles for those at the interface between pharma and medicine.
3. theheart.org Search on `CETP inhibition' and click on the first on the list. You may have to register on this site but anyone can and it only takes a moment. Listen to three top medical doctors and researchers talk about their research on new ways of reducing cardiovascular risk. You don't need to understand the detail (its basically about good and bad cholesterol). One interesting aspect of this is that it's another trial which actually failed, rather like the HPS-2 trial mentioned above, something that Dr Goldacre would have us believe is rarely publicised. But just listen to the enthusiasm and the transparency which Dr Goldacre seems to doubt exists in the `pharma - medicine axis'. These guys are also medical practitioners and are at the cutting edge of research into new medicines, clearly concerned to do the very best for their patients and to hide nothing relevant. These are the brains behind the search for our new medicines; the kind of people Dr Goldacre believes are corrupt and manipulate statistics. Decide yourself.
4. merck.com Search for `river blindness' to read about the donation of a drug by a pharma company to a diseased population. Many companies run similar ethical not for profit programs; this is just one example I know about. It would have been nice for the author to have acknowledged that such work goes on in the pharma industry against its overall mission to improve the world's health. But sadly this wasn't the author's agenda.
Finally, if you do read this book, make you own judgement about whether medicine is broken or not and perhaps question why the author ever wrote this book. I suspect Dr Goldacre's future however is more likely in investigative journalism and writing/selling more books than in genuinely promoting an increasingly regulated and ethical pharmaceutical industry from within; such a pity for one so well qualified to do so. My own declaration is that after working as a University Senior Lecturer, I spent 11 years working in three pharmaceutical companies in the Medical Affairs sections. Now semi-retired, I work part-time in the NHS so have no current industry interests. Forced to rate on a star basis out of five, this book doesn't get any stars from me I'm afraid (oh, Amazon force me to give it at least one). The book unfairly disparages the industry which supplies medicines to promote our future health by focussing on issues which can be corrected, but not like this.
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