‘Bad Science: Quacks, Hacks, and Big Pharma Flacks (Charlatans, médecins à gages et attachés de presse de Big Pharma’), is a book written in 2010 by Ben Goldacre, an English doctor who is also researcher at the London School of Hygiene and Tropical Medicine.
The main issue is how medical reviews refrain from publishing the whole truth about the side-effects of some drugs. For instance, out of seven clinical trials carried on a specific drug, the positive result of only one test is given publication and brought to the notice of physicians. The data collected from the six others, which involved six times the number of patients, and which are negative, are not published. Comparative studies of the drug with another drug were also not published. Such lack of transparency aroused the anger of Ben Goldacre.
Another book followed in 2013, ‘Bad Pharma : How Drug Companies Mislead Doctors and Harm Patients’. His ideal is that all data collected from experiments carried out on patients should be made accessible, free of charge, to the public at large. Only total access to the data can help doctors prescribe the most efficient medicine. In his new book, Goldacre points out how the medical world is far from this ideal. Only half of all clinical studies are said to be communicated to specialized medical reviews. Bad Pharma is a harsh criticism levelled at the academic-industrial nexus, and the way it has perverted all publications related to the efficiency of drugs. The other point raised by Goldacre is that patients who accept to participate in experiments are hardly aware that the data may never be published.
What angers the writer is that if the publications on which doctors rely to take decisions reflect only an incomplete sample of prior studies, how can they trust the drugs they prescribe? Wrong information leads to wrong decisions, resulting in undue physical and mental suffering, and sometimes cause the death of other human beings. Regulation and registration of laboratory tests is another handicap despite the 2004 EMA law in the European Union, and by mid-2012, 10,000 tests were still not registered. Fishy negotiations between independent researchers and a few laboratories and the EMA over data communication concerning the use of Tamiflu to treat influenza are also pointed at. Laboratories withholding information from scientists is common practice, and undermines the work carried out by the latter.
The situation is not any better in the US where the 2007 law on FDA (Food and Drug Administration) which demands that all data concerning drug tests be put on the website clinicaltrialsgov at the latest a year after experimentation is hardly implemented notwithstanding a fine of 10,000 dollars per day for non-respect of the law. Actually, only one fifth of all the tests, which are on the site, abide by the injunction. The FDA barely carries a regular check on the implementation of the law. Up to now, no official public audit has been done nor has any laboratory or researcher been fined for not divulging important information relating to drug tests on patients. The issue of the missing data is unlikely to be solved despite legislation and the commitment of medical reviews to demand registration of clinical trials, and as long as resources to check and penalize those who are ordering drug trials to be carried out are lacking.
What Goldacre aims at is to inform the public on drug manufacturing processes and how criminal practices of drug companies impact on the process. Seemingly, the latter leave no stone unturned and find devious means to manipulate, falsify and even invent clinical data by carrying tests on very few people or within a very short period, by providing biased comparison with competitors’ drugs, by recruiting patients selectively and not registering data collected on patients who give up on experimentation.
The marketing strategy of drug companies is another alarming issue. They spot all the flaws in the training of physicians. Basically, the main source of information of updated knowledge to doctors comes from laboratories, which have close links with marketing managers. The writer describes how laboratory representatives bribe staffs in hospitals with flowers and gifts, and how firms study the psychological profile of doctors with a view to finding ways and means to influence them.
A few examples of withholding negative results of drug trials would include drugs for anti-depression which are ineffective and harmful, and increase the rate of suicide among adolescents. A laboratory was compelled to withdraw an anti-inflammatory drug from the market following revelation of its harmfulness. In Europe, drug companies have been fined for promoting unauthorized use of drugs to treat epilepsy, growth hormone and others. Hospital doctors who have observed the cardiovascular risks posed by anti-diabetes drug are harassed by the drug company that produces it. Recently, a trade union of drug companies accused a group of researchers of ill-conduct and dishonesty in letters that the latter sent to medical reviews and ministries. They were reproached for revealing to what extent committed academics whose work is financed by the drug industry are allowed to publish their findings under conditions set by the companies.The case of an European firm which carried out tests on an antibiotic drug in Nigeria is also mentioned. The trial of the company lasted thirteen years, and Wikileaks disclosed other facts in 2010. Currently, there is a propensity for companies to test drugs on patients in poor and emerging countries, which poses an ethical problem.
The writer raises the question of who should exert final control on communication of data collected from drug trials. Insofar as 90% of trials are financed by the drug industry, laboratories are the ones which decide if and when information should be brought to public notice. Right now, the priority of the industry overrules the interests of patients. The question that arises is: Would patients be willing to participate in trials paid by laboratories if they knew that the data resulting from experimentation on their bodies will never be made available to researchers to enable them to make progress in medical science and improve treatment?
One solution suggested by the writer is that of having trials based on medical files of patients which doctors submit for analysis and which enable them to participate in the control on recruitment and efficiency. Goldacre is personally working on a comparative study of two anti-cholesterol drugs which are widely used in several countries. Two drugs, one against cancer and the other against high blood pressure need urgent revision. Unfortunately, doctors are too often overworked or do not have access to all the data, and very often let commercial motivation outweigh the interest of patients. In other cases, they actively participate in the corruption of data published in medical reviews.
The writer highlights the ideal which the whole industry, doctors and ministries should make it their duty to follow for public interest. Public health is a major concern for one and all, and in Mauritius too, an increasing awareness should be promoted on the medicines patients are given to swallow.
* Published in print edition on 18 July 2014