Companies claim drugs’ side effects are commercial secrets

Patients lobby against transparency

Another example of the remarkable lengths the industry is prepared to go to block transparency legislation, emerged in an email, leaked to the Observer newspaper in July, about a plan to encourage patient groups to lobby against it. Organised by two pharmaceutical trade groups – the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPPIA), the idea was for patient groups to say how worried they were about “the risk to public health by non-scientific re-use of the data.”

This was at the same time as other parts of the industry were saying that fully informing patients and doctors about risks was unacceptable because it might impact on profits.

At the moment it doesn’t look as if these ruthless lobbying tactics are going to succeed. At the end of the year the draft of a new European bill was agreed that aimed to prevent companies hiding unfavourable results. Change is certainly needed. One third of large clinical trials have not been published five years later, according to a recent study published in the BMJ. The journal has also carried another study showing that hidden trials provide more than twice as much information about a drug’s benefits and harms than the published ones do.

The EU Clinical Trials regulation bill will mean that researchers running clinical trials in Europe will have to register them when they start and then publish a summary of the results within a year of it ending. Despite Dr Wolfe’s evidence that fines are ineffective, they are the only sanction proposed at the moment.

Another sign that there is growing political momentum for change is the damming report by the Public Accounts Committee published last week which commented it was: “surprised and concerned to discover that information is routinely withheld from doctors and researchers” and recommended that data from all the trials of current drugs be made available, which is more radical than the EU bill which only deals with future trials.

For decades clinical trials have been regulated on the fox-guarding-the-henhouse principle, making a mockery of grandiose claims about evidence based medicine; letting in the sunshine is long overdue. But transparent clinical trials alone are not the panacea that some campaigners seem to think.

They have plenty of shortcomings such as trialling a single drug on subjects who are relatively young and healthy when the bulk of drugs are used on elderly people taking several other drugs as well. The results obtained in even well run clinical trials are far more favourable than the benefits when patients get them in the real world.

What this means is that the true picture of drug effectiveness is very likely to be much poorer than is assumed at the moment. This is yet another reason why they should no longer be seen as the dominant solution to our epidemic of metabolic diseases and why a switch to proper funding of research into prevention and lifestyle changes is also long overdue.

Melayna Lamb

Melayna Lamb

Melayna Lamb is a University of Sussex graduate with a masters in political philosophy. She specialises in the philosophy of law, with a particular interest in the operations of the pharmaceutical industry. She now works for a human rights NGO.
Melayna Lamb

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