Drug safety reports are kept secret

DRUG side-effects including deaths, birth defects and disability are the fifth biggest cause of death in European hospitals, but reports on these dangers are being kept secret.

The European Commission is under pressure to change this as part of its pharma package — being finalised for release at the end of November.

However, plans to end the ban on drug advertising and hand responsibility for managing drug safety to the pharmaceutical companies have been criticised.

The pharma package was due to be published this week in Brussels but was withdrawn at the last minute and is being reviewed, a commission spokesperson said.

Various governments, including the Dutch, and patient lobby groups such as Health Action International (HAI) want drug safety update reports made available.

Currently, only a safety summary, that does not include sufficient details for independent scientists to evaluate the evidence, is made available by companies to interested groups.

The Dutch Ministry of Health said periodic safety update reports (PSURs) provide important safety information and should be available to the public.

“There cannot be a reason to withhold safety information from the general public,” the ministry said.

However, it is understood the commission has not proposed such a step, even though this information is freely available in the US.

Last year the drug company Roche threatened to sue the Danish government if it released drug information to the public that subsequently caused Roche to lose money or market share.

It is understood the commission has proposed changing legislation that prohibits drug companies advertising their products to the public, but deny it would allow US-style advertising.

Dr Barbara Mintzes of HAI said it was difficult to see why the legislation should be changed, when such advertising had proved unhelpful to the US public.

An example of companies’ reluctance to publicise negative effects was Merck’s Vioxx medication for arthritis, eventually shown to cause stroke and heart problems. The company claimed these side-effects only became apparent with longer term use, but it later emerged the problems were in fact clear from earlier on.


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