The story of Thalidomide will be familiar to most of us, especially those who grew up in the 50's and 60's. The drug was first marketed in West Germany under the name Contergan by Chemie Grünenthalin 1957. Although initially prescribed as a sedative-hypnotic, it was soon found to be effective for nausea and morning sickness in pregnant women and was aggressively marketed for this use. We should remember that at this time there was little regulatory control over the use of medications during pregnancy and drugs were not routinely tested for potential harms to the foetus.
Unfortunately, as it turned out, Thalidomide became one of the most successful prescription drugs in the history of medicine. In the UK, Australia and New Zealand it was marketed by The Distillers Company (Biochemicals) Ltd, under the brand name Distavel as a remedy for morning sickness. The advertising literature claimed that Distavel was 'outstandingly safe' for pregnant women and nursing mothers. By the end of the 1950s, 14 pharmaceutical companies were marketing Thalidomide in 46 countries under at least 37 different trade names.
As a result of this drug, around 5,000 infants were born with malformation of the limbs (phocomelia) in Germany alone, and only about 40% of these children survived. Throughout the world more than 10,000 cases were reported of infants with phocomelia due to Thalidomide, with around 50% survival rate. In addition to limb malformations the adverse effects of Thalidomide included deformed eyes, hearts, alimentary and urinary tracts, blindness and deafness.
In November 1961, Thalidomide was taken off the market mainly due to pressure from the press and the general public. Although most victims of Thalidomide in Europe received compensation in the aftermath of this tragedy, it was not until December, 2013 that a class action filed by over 100 survivors in Australia and New Zealand was settled.
The Thalidomide tragedy led to the development world wide of more structured regulations and control over drug use and development, and many countries, including the US, EU, Australia and Canada introduced much more stringent rules for the testing and marketing of pharmaceutical drugs. In the US, which had never granted approval for thalidomide, President Kennedy honored the FDA pharmacologist, Frances Kelsey, with the President's Award for Distinguished Federal CivilianService for her key role in denying Richardson-Merrell approval to market Thalidomide (despite intimidation from company representatives). The well-publicized 1962 ceremony provided a powerful symbol of the resolute will of governments and their agencies to protect the general public from the profit motivated malevolence of pharmaceutical companies.
To most people, these regulatory changes, which ushered in the 'enlightened' age of evidence based medicine, were enough to restore trust in doctors and the drugs they prescribed. However, the alarming stories around such drugs as the COX-2 inhibitors (e.g. Vioxx), the SSRI's (e.g. Prosac), and more recently the statins (as exposed on ABC television) show us that these tough new regulations and the institutions charged with enforcing them may not be up the task. In fact, prescription drugs are currently the third major killer after heart disease and cancer. In the introductory chapter, the author notes that if this were a new type of disease, a cancer or some sort of epidemic, killing people in such large numbers, surely there would be a great deal of media attention focused upon it, with patient groups raising money and lobbying governments to act urgently to eradicate this scourge. Why is there such silence and resigned acceptance when it comes to the widespread harms caused by pharmaceutical drugs?
In this landmark publication, researcher and physician Dr Peter Gøtzsche traces the sorry history of deception, bribery and corruption that has allowed this extraordinary situation to develop. Dr Gøtzsche is co-founder of the Cochrane Collaboration, of which he is still a director, and also founding director of the Nordic Cochrane Centre. Since 2010 he has been Professor of Clinical Research Design and Analysis at the University of Copenhagen. He has published over 50 papers in the major peer reviewed medical journals and participated in 40 meta-analyses and systematic reviews published in the Cochrane Database of Systematic Reviews. Moreover, judging by the way he writes, the man is a true scientist with an innate respect, indeed love, for truth and distain for falsehood in all its forms.
As the title of the book suggests, Dr Gøtzsche draws a parallel between the drug industry and the mafia. In examining the world's 10 largest drug companies he has exposed activities generally associated with organized crime, such as fraud, federal drug offences, bribery, obstruction of justice, obstruction of law enforcement, tampering with witnesses and political corruption. However, in addition to finding the law to be a major impediment to their pursuit of unlimited profits, the pharmaceutical industry has also faced another annoying obstacle that the mob doesn't need to negotiate: scientific integrity.
Also unfolding within these pages is the story of the artful seduction of medical professionals by the industry: how legitimate payments for representing their interests at live events and in print gradually, almost imperceptibly, morph into frank bribery, stripping these 'industry whores' of their professional integrity and reducing them to the level of circus animals. The numbers of such paid professional spokespersons for Big Pharma is both staggering and alarming!
Dr Gøtzsche describes the lengths to which one has to go in order to retrieve scientific information, which should be freely accessible, both to the profession and to us all. These data remain the commercial in confidence 'property' of the drug company that sponsored the clinical trial of their drug – while enlisting the help of medical staff and volunteer patients who believe they are contributing towards scientific advancement for the benefit of humanity. We are also shown how such trials are in most instances improperly conducted in order to minimize or hide harms and exaggerate clinical efficacy. As Dr Gøtzsche explains in a recent interview:
There are very little high-quality published data. Neither the drug industry nor publicly employed researchers are particularly willing to share their data with others, which essentially means that science ceases to exist. Scrutiny of data by others is a fundamental aspect of science that moves science forward, but that's not how it works in healthcare. Most doctors are willing to add their names to articles produced by drug companies, although they are being denied access to the data they and their patients have produced and without which the articles cannot be written. This is corruption of academic integrity and betrayal of the trust patients have in the research enterprise. No self-respecting scientists should publish findings based on data to which they do not have free and full access.
After elaborating on such activities by the drug industry, government regulators and the medical profession, together with the devastating consequences for patients, which are largely foreseeable if you have access to all the data, several of the following chapters focus on specific drugs or classes of drugs. Here we are given an in depth examination of 'popular' drugs that have very little or no effect but very real dangers (i.e. potential harms outweigh potential benefits) or have been marketed mainly for off label uses (which is both illegal and unscientific as there is no evidence of efficacy) or that should be used in a very restricted way but are targeted for widespread use. Topics covered include 'slimming pills', Neurotonin, NSAID's (specifically the COX-2 inhibitors), anti-diabetic drugs, the SSRI 'antidepressants', and antipsychotics.