Healthy Skepticism Library item: 959

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

White M.
Tighter controls promised on drug claims: Pharmaceutical companies to be forced to publish details of side-effects
The Guardian 2005 Apr 12

Full text:

Pharmaceutical companies will be forced to publish the findings of all their clinical trials, including potentially adverse side effects, as a condition for obtaining a UK marketing licence for new drugs, Labour’s election manifesto will promise tomorrow.

It would mean that both doctors and patients would be able to check the downside of “wonder drugs” being promoted by the big global firms simply by logging on to an agreed website which meets internationally endorsed standards of openness.

The proposed change, which would require legislation in the next parliament, would help to restore public trust on both sides of the Atlantic, after confidence in the industry was undermined by a series of scares.

The move, proposed by the health secretary, John Reid, follows years of controversy and concern about such drug groups as anti-depressants, which are widely suspected of making children or young people suicidal or aggressive.

An 18-month inquiry by the Medicines and Healthcare Products Regulatory Authority
(MHRA) concluded last December that there was no firm evidence of drugs such as Prozac and Seroxat causing self-harm or suicide in adults, unlike its conclusion a year earlier that young people were at risk. It recommended monitoring of the under-30s and steps to ensure depressed patients do not exceed the stated dose. But the royal colleges of medicine and mental health charities still complain that the regulator had seen only the firms’ own summaries of the clinical trials.

“People sometimes wonder if early warning signs of the downside haven’t been missed or concealed,” a Labour official said.

The side effects of anti-stroke drugs such as Vioxx and other inhibitor medicines have also been the subject of concern.

Some drug companies have been caught out not publishing data which did not support their own claims about the benefits from potentially profitable discoveries.

As a result of disappointing results from health minister Lord Warner’s efforts to encourage more voluntary openness – encouraged by the industry’s own association – the wording of tomorrow’s manifesto will state: “We will require registration of all clinical trials and publication of their findings for all trials of medical products with a marketing authorisation in the UK.”

In practice it will mean that new drugs would be licensed only if their trial data was published in a “peer review” journal – the top medical magazines – or on a recognisable database, such as the MHRA’s website or others approved by the World Health Organisation, within three months of getting the licence.