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Healthcare

EU body under fire for Roche, Astra drug decisions

* Call for more transparency, questions over drug licensing

* Criticism in Lancet journal echoes attacks on U.S. FDA

LONDON, May 21 (Reuters) - The European Medicines Agency (EMA) came under fire on Friday for recent decisions related to drugs from Roche ROG.VX and AstraZeneca Plc AZN.L, which some medical experts said were questionable.

The respected Lancet medical journal called for greater transparency and challenged the way the watchdog made some of its licensing decisions. The criticism is reminiscent of past attacks on the U.S. Food and Drug Administration (FDA).

An editorial criticised the European regulator for not releasing documentation on severe adverse reactions linked to Roche Holding AG’s acne drug Accutane, or isotretinoin, following a request from an Irish citizen whose son committed suicide in 1997.

The EMA argued that European transparency rules did not apply to serious adverse reaction reports, but the European Ombudsman recently called on the agency to reconsider. The EMA said it would give its response to the Ombudsman by July 31.

Accutane, which Roche said last year it would stop selling because of generic competition, has had a controversial history since its launch in 1982.

While powerful at clearing acne, the drug has been linked to birth defects if taken during pregnancy and has also been suspected of causing mental side effects, although Roche has vigorously defended personal injury claims in this area.

At the same time, questions were raised in the Lancet about a recent extended licence for AstraZeneca’s cholesterol drug Crestor, or rosuvastatin, following results of a clinical trial called Jupiter.

Paul Ridker and Robert Glynn of Brigham and Women’s Hospital in Boston, Mass., who led the Jupiter study, said the new use recommended by the EMA was based not on the trial’s pre-specified main goal but on an analysis of a subgroup of patients done after the event.

Such post-hoc analyses are generally considered to provide much weaker evidence of a drug’s effectiveness.

“Citizens of EU member states should welcome and support transparency initiatives within EMA, which might bring about more openness on licensing decisions and suspected adverse reactions,” the Lancet said.

In the United States, the FDA has come under fierce attack in recent years over its decisions surrounding drugs such as Merck & Co's MRK.N pain treatment Vioxx -- now withdrawn from the market -- and GlaxoSmithKline Plc's GSK.L diabetes pill Avandia.

That has led to the creation of an internal Transparency Task Force at the FDA, but the Washington agency remains under pressure to make more information public. [ID:nN19227109] (Editing by David Holmes)

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