Reviewed by: Yeong Sek Yee & Khadijah Shaari

Dr Ben Michael Goldacre, the author,  graduated in 1995 with a first-class honors degree in medicine from Magdalen College, Oxford. He obtained an MA in philosophy from Kings College London, and undertook clinical training at UCL Medical School, qualifying as a medical doctor in 2000 and as a psychiatrist in 2005. As of 2012 he is Wellcome research fellow in epidemiology at the London School of Hygiene and Tropical Medicine.

We have heard about “Big Pharma.” Little did we know that it is also known as “Bad Pharma” and this book certainly enlightened us. According to Dr Goldacre, the whole edifice of medicine is broken, because the evidence that we (the doctors) use to make decisions is hopelessly and systematically distorted. We (doctors) like to imagine that:

ü  Medicine is based on evidence, and the results of fair tests. In reality, those tests are often profoundly flawed.

ü  Doctors are familiar with the research literature, when in reality much of it is hidden from them by drug companies.

ü  Doctors are well-educated, when in reality much of their education is funded by industry.

ü  Regulators only let effective drugs onto the market, when in reality they approve hopeless drugs, with data on side effects casually withheld from doctors and patients. 

The essence of the whole book is distilled and summarized in the introductory pages of the book. The following paragraphs meticulously defends every assertion made by Dr Goldacre:

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects.

Regulators see most of the trial data, but only from early on in its life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are the patient groups.

And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company.

Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part, they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.

Watch Dr Ben Goldacre’s speech on TEDTALK…What doctors don’t know about the drugs they prescribe…LINK:

http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html

From the above, it is very clear that from Dr Goldacre’s perspective, medicine’s evidence base has been undermined by an unscrupulous alliance of the pharmaceutical industry and regulators, which leads to the routine suppression of negative studies revealing many drugs to be either ineffective or less effective than those they seek to replace.

This suppression has been willful and many academics (the industry’s “key opinion leaders”) have acted as willing partners in the enterprise, putting their names to ghostwritten articles reporting positive trials, while failing to publish negative trials.

Since there’s so much missing data, we (doctors) can’t really say whether the therapies we use work or not. Doctors generally want to do the best for their patients, but they can’t know what that is if half of the data on clinical trials of drugs is missing and some of the rest is distorted.  Thus, according to Goldacre, medicine’s evidence base is irredeemably corrupted and needs reconstruction.

This book (448 pages) is divided into six chapters, which cover different aspects of the pharmaceutical industry:

Chapter 1 is entitled ‘Missing data’, and Dr Goldacre described at considerable length the important problem of publication bias. The take home message from this chapter is that we cannot assess the evidence for a particular drug if all the trials on it are not published, and worse still, those that are not published tend to be different from the ones that are.

Chapter 2 ‘Where Do New Drugs come from?’ is a brief description of the drug development process. Risky ‘first-in-man drug tests are conducted on homeless people, full clinical trials are globalised which raises serious ethical problems…also trial participants  in developing countries are often unlikely  to benefit from expensive new drugs…thus it also raises new problems for trusting the data.

Chapter 3 ‘Bad Regulators’, does what it says on the tin, and explains the many ways in which Goldacre believes that drug regulation isn’t working.  The bar is very low: that drugs must only prove that they are better than nothing, even when there are highly effective treatments on the market already….this means that real patients are given dummy placebo pills for no good reason.

Chapter 4 ‘Bad Trials’ talks about the design of individual clinical studies and how they can be flawed. Several tricks have been introduced…one allows researchers to overstate and exaggerate the benefits of the treatments they are testing.

Chapter 5 ‘Bigger, Simpler Trials’ describes how pragmatic randomised trials could be (but very rarely are) incorporated into routine clinical practice.

Chapter 6 ’Marketing’  In this chapter, Dr. Goldacre addresses the abuses and excesses of the pharmaceutical industry marketing machine, which exists entirely to increase the revenue generated by the industry’s products and yet which masquerades as a system for disseminating useful information to doctors, patients, and politicians.

When you have read all the 6 chapters (as we did during the Ramadan), you will realize why Dr Goldacre decided to title the book as Bad Pharma. For the still unconvinced, we recommend that you peruse the following articles with the links as attached:

1)    List of largest pharmaceutical settlements

Link: http://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements

2)    List of off-label promotion pharmaceutical settlements

Link: http://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical_settlements

3)    Pharmaceutical frauds

Link: http://en.wikipedia.org/wiki/Pharmaceutical_fraud

4)    GlaxoSmithKline controversies

Link: http://en.wikipedia.org/wiki/GlaxoSmithKline#Controversies

 5)    Ethics in pharmaceutical sales

Link: http://en.wikipedia.org/wiki/Ethics_in_pharmaceutical_sales

 6)    Pharmaceutical marketing

Link: http://en.wikipedia.org/wiki/Pharmaceutical_marketing

7) Why doctors don’t know what they’re prescribing

Link: http://www.abc.net.au/unleashed/4323556.html

NB: In the list of pharmaceutical settlements, most of the fines runs into hundreds of millions (USD) and mainly for offences like off-label promotions, false marketing, kickbacks, medicare fraud, etc. Recently a drug company was fined US 3 billion for various offences (see link below). To Dr Goldacre, these fines/settlements are just small change to Big Pharma.

Link: http://www.justice.gov/opa/pr/2012/July/12-civ-842.html

In addition to the above, you may want to read the following books (there are many, many more such type of books):

1)    Big Pharma: How the World’s Biggest Drug Companies Control Illness is a 2006 book by British journalist Jacky Law. The book examines how major pharmaceutical companies determine which health care problems are publicised and researched.

2)    Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial is a nonfiction book by investigative journalist Alison Bass, which tells the true story of a court case and the personal drama that surrounded the making of a bestselling drug. It chronicles the lives of two women – a prosecutor and a whistleblower – who exposed deception in the research and marketing of Paxil, an antidepressant prescribed to millions of children and adults. The book shows the connections between pharmaceutical giant GlaxoSmithKline (the maker of Paxil), a top Ivy League research institution, and the government agency designed to protect the public – conflicted relationships that arguably compromised the health and safety of vulnerable children.

3)    The Emperor’s New Drugs: Exploding the Antidepressant Myth by Irving Kirsch demonstrated that in trials, SSRIs (a common class of antidepressants known as selective serotonin re-uptake inhibitors) performed no better than placebos, a fact that would have been known had some clinical trial data not been suppressed by pharmaceutical companies. Regulators happily licensed these new drugs in full possession of this knowledge.

4)    The Truth About the Drug Companies…How they Deceive us and What to do about it by Dr Marcia Angell, MD…..read how the drug companies promote diseases to match their drugs and have  enormous influence over what doctors are taught about drugs and what they prescribe. Drug companies have substantial control over clinical trials of their drugs…as a result the research results are biased.

5)    What the Drug Companies Won’t Tell you and Your Doctor Doesn’t Know by Michael Murray, N.D.…the alternative treatments that may change your life –and the prescriptions that could harm you.

6)    Rethinking The Ethics of Clinical Research….Widening The Lens by Dr Alan Wertheimer, MD……Clinical research requires that some people be used and possibly harmed for the benefit of others. What justifies such use of people? This book provides an in-depth philosophical analysis of several crucial issues raised by that question.

7)    Money Driven Medicine by Dr David K. Cundiff, MD….Read the details of dozens of prescription drugs which extensive research has proven to be ineffective or dangerous for continued use.

After reading the whole book and the various links, we are really amazed how Big Pharma has the courage to market their drugs as “scientifically tested, evidence-based,” etc, etc (and everything else is not scientifically tested and not evidence-based). How can Big Pharma’s drugs be “scientifically tested and evidence-based” when clinical trials designs are flawed, negative data are missing/not revealed, and regulators, doctors and politicians are bribed or silenced, etc, etc. As Dr Goldacre mentioned, medicine’s evidence is irredeemably corrupted and needs serious re-construction. But, will it ever happen when there is so much at stake?

Perhaps, Dr Goldacre should have named the book as BIG, BAD PHARMA. What do you think?