Keep taking the tablets?

Submitted by Anon on 8 October, 2004 - 10:08

By Mike Fenwick

A recent Panorama programme exposed the growing concerns over the procedures by which drugs are licensed for use in Britain.

It has been long known that the pharmaceutical industry and medicine have close links. You can’t go into many GP surgeries without noticing the free stationery, calculators, pens, “educational” posters and leaflets adorned with the logo of a particular drug or company.

Worse are the conferences (often international) which drug companies sponsor individual clinicians to attend to “help keep their knowledge up to date”, but on condition of going to a promotional activity for the latest wonderdrug on the market. A Guardian series has said such sponsorship is worth up to £50,000 a year for senior doctors and “opinion formers”. The industry-medic alliance permeates through to the highest levels of the medical establishment.

Panorama focused on the case of the licence given to Seroxat (Paroxetine), an antidepressant similar to Prozac, where not only were initial checks inadequate but the failsafe systems proved ineffective.

Glaxo Smith Kline, the drug company involved, presented only partial evidence about the potential side effects, effects which had become clear in some of the earliest clinical trials. These problems were all serious: a possible increase in suicidal thinking, evidence of a dependency on the drug and some uncomfortable side effects if the medication was introduced or increased too rapidly.

The current method of assessment for a new medication by the Medicines Healthcare Products Regulatory Athority (MHRA) is to study the data presented by the drugs company on its effectiveness in randomised controlled trials (the gold standard of scientific evidence). Only rarely will any evidence produced independently be considered at that stage. Where such independent reviews are commissioned by a body such as NICE (National Institute for Clinical Excellence) the results can be undermined by the financial clout of the drug companies.

When Glaxo were seeking a recommendation for use of a new drug for flu symptoms a few years ago NICE initially reported that the evidence for its effectiveness did not justify the cost. Glaxo threatened to withdraw its operations from Britain and the decision was reversed.

Open disclosure about potential problems would not necessarily stop a new drug being licensed if the potential benefits outweigh the costs. But decisions can be manipulated. The Guardian has shown how a supposedly independent adviser privately briefed a drug company about how best to present their case.

When complaints and concerns about Seroxat started to be logged through the “yellow card” scheme, for reporting side effects, they were not acted on. The scheme is the main failsafe for monitoring medication.

Such omissions are only occasionally exposed. Most recently the focus has been on anti-depressants. This reflects the strength of the mental health service users’ movement who are not prepared to take the tablets unquestioningly.

In other areas of medicine, patient and carers may feel less empowered to question a doctor’s opinion.

Some trusts are seeking to act to reduce the influence of drug company reps, limiting them to contact with hospital pharmacists rather than clinicians. It means ward staff lose out on the occasional Marks and Spencer sandwich and other freebies, but shores up the concept of professional integrity in making objective judgements about treatment.

Some professionals fail to see the point, believing they are above such subtle influences and are getting something for nothing of the drug companies. However, the additional costs of all this marketing is borne directly by the NHS in inflated drug budgets. As they say there is no free lunch, and the price of a drug company lunch is public confidence in medicine.

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