Media lift lid on secret reports on drug side-effects

22.10.08 @ 10:51

  1. By Brigitte Alfter, Marleen Teugels and Joop Bouma

BRUSSELS - Adverse reactions to medication is the fifth most common cause of death in hospitals according to the European Commission, but EU agencies and national governments have until now kept secret pharmaceutical companies' reports on side-effects.

  • The industry says documents of this type are easily misunderstood and misinterpreted. (Photo: www.freeimages.co.uk)

The notes - known in the business as Periodic Safety Update Reports (PSURs) - are submitted regularly to national authorities and the European Medicines Agency in London.

The PSURs for example detail how doctors in various countries suspect that teenagers grow suicidal when taking a certain medication against pimples, or that a diet product could lead to a stroke and what industry has to say about the medical fears.

A team of Dutch, Danish and Belgian journalists has now used freedom of information legislation in the Netherlands and Denmark to get partial access to the documents, where patient gender, age and country of origin are blacked out to protect privacy and business interests. A legal decision is pending in Belgium.

The move by Dutch daily newspaper Trouw, Belgian magazine Knack in cooperation with Danish magazine Samvirke to put the documents on the internet comes as the European Commission on Tuesday (22 October) decided to delay the publication of a new package of regulation for drugs producers.

The commission package is not expected to mandate publication of PSURs but is likely to allow pharmaceutical companies to contact patients directly - a practice that is currently illegal and was condemned by the European Parliament in 2002.

"In my view, there can be no doubt that PSURs should be made public. After all this is about the side-effects on medicines that we take," Margrethe Nielsen, a researcher at the Cochrane Institute's Copenhagen branch and a specialist on pharmaceuticals told EUobserver.

She added that the notes, which form the basis of government understanding of the sector, are not based on clinically controlled tests method. "This is maybe the most important: this does not build on sound science," she said. "I would not be able to use them for my work."

"In these reports [released in the Netherlands and Denmark] much too much has been blackened. The quality is unequal. It is of big importance that these safety reports can be accessible for everybody so that scientists can debate about their quality," Canadian expert Barbara Mintzes told Knack.

Reacting in a test case on PSUR publication in Denmark in 2007, lawyers for drug firm Roche threatened to sue the Danish state if disclosure harmed the company's commercial interests.

"A competitor can use the reports as a basis for guidance to patients and guidance to doctors. Competitors can with the help of PSUR reports obtain a basis to take care of guiding functions, that can weaken Roches position on the market and thus bring significant negative economic effects for Roche worldwide," the company's legal advisors wrote in letters to Danish authorities.

"Experience shows, that documents of this type are easily misunderstood and misinterpreted, for example by journalists," the letters add. "Misunderstandings of this type can cause severe disturbance of the market and thus loss for Roche."

The view is shared by the Brussels-based trade lobby, the European Federation of Pharmaceutical Industries and Associations (EFPIA), today.

"The trouble is, they have to be understandable. You need to be an expert, to understand them. I would push that back to the regulator to take proper action. When you pull information, it has to be in a form, that you and I can understand," EFPIA director Brian Ager said.

"The industry claims that the people wouldn't understand them. In reality making the side effects public would influence the stock exchange in a negative way," French medical journal Prescire's editor Bruno Toussaint said.

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