113. Can We Trust the Drug Companies?

The banking industry quite rightly suffers from public opprobrium because of its role in the financial crisis, manipulation of the bank rate and mis-selling of various products. By contrast the pharmaceutical industry is somewhat more highly regarded. Nevertheless recent examples of unethical behaviour indicate that the approach to business in this sector does not exactly embrace the highest principles of corporate social responsibility.

I have just discovered a website which provides reliable evidence on how this industry operates (1). In this blog I will refer to a number of issues which have arisen in recent years.

In an undercover investigation, initiated by a tip-off from a whistleblower, The Daily Telegraph discovered that pharmaceutical firms appear to have rigged the market in so-called “specials”. These are prescription drugs that are largely not covered by national NHS price regulations. Secret recordings by Telegraph reporters showed that sales representatives for drug firms offered to provide apparently falsified invoices allowing chemists to bill the NHS for sums far greater than they would spend. Hence the retailers would be able to send inflated invoices to the NHS, allowing them to pocket the difference. As a consequence it was estimated that hundreds of millions of pounds of public money has probably been wasted in recent years due to the practice (2).
In a Newsweek investigation, reporter Sharon Begley concludes that the framework of medical research is fundamentally flawed so that the wrong answers are being produced time and time again (3). According to John Ioannidis, who is in charge of the Prevention Research Center at Stanford University people are being hurt and dying because of false medical claims which are based faulty research.
In a recent blog I have described in detail how pressure was applied to the respected Cochrane Collaboration to influence the conclusions of an evaluation of statins (4). Two professors from the University of Oxford persuaded the compilers of the report to reach a conclusion favourable to statins, based on data produced by pharmaceutical companies, which was not open to independent scrutiny. Other evaluations have concluded that there is no net benefit from statins when used for primary prevention. Despite this NICE has made recommendations which effectively mean that everyone over 50 will be offered statins. Even NICE accepts that 77 people will have to treated in order that one will benefit! In the USA alone the expenditure on statins is more than $20 billion per year, much of which is probably unnecessary.
There are many examples of “breakthroughs” which turn out to worthless when subjected to further examination. Various studies which concluded that popular antidepressants work by altering brain chemistry have now been contradicted. A study done in 1996 which concluded that estrogen therapy reduces older women’s risk of Alzheimer’s was overturned in 2004.
Richard Smith, a former editor of the British Medical Journal (BMJ) is convinced that fraudulent research regularly appears in the 30,000 scientific journals currently published throughout the world. Furthermore even when fabricated or falsified research is discovered, journals rarely publish a retraction. Dr Smith is critical of the failure of scientific institutions, including universities, to discipline dodgy researchers even when alerted to problems by journals. Most cases are not publicised. Few countries have measures in place to ensure research is carried out ethically. In practice such incidents are simply not recognised, covered up altogether or the guilty researcher is urged to retrain, move to another institution or retire from research (5).
Ben Goldacre trained as a medical doctor and is the author of the “Bad Science” column in The Guardian. In his book “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” he describes how he ended up prescribing the antidepressant reboxetine to his patients based on insufficient data. Despite the fact that there is overwhelming research which shows that the drug is ineffective, it was still approved in the U.K. In order to get approval of the drug in Europe, the manufacturer had simply kept quiet about its negative data. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had shown a positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. Goldacre had no idea they existed. It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this showed that patients on reboxetine did worse than those on other drugs. He goes on to describe how drug companies hide data about medication risks that affect children, how they attempt to intimidate the employers of researchers who produce results they don’t like, and how they routinely withhold safety data in various other ways that do harm to patients (5).The fundamental problem is that the regulatory bodies, which we would reasonably expect to stamp out such practices have failed us. 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 that are flawed by design, in such a way that they exaggerate the benefits of treatments. There is good evidence to demonstrate that the results of research funded by drug companies are highly likely to favour the manufacturer. On the other hand if the results are not favourable then there is absolutely no obligation to make these public. Consequently doctors and patients, only ever see a distorted picture of true effects of any particular drug. In view of the fact that the drug companies are the main source of information to the medical profession this is the picture which becomes widely disseminated. This is reinforced by the fact that the same messages are promulgated through the scientific journals. Although these are usually regarded as objective the reality is that are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by a single drug company (6).

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