Lonngren lashes out at late warning
pharmafile | November 1, 2004 | News story | | EMA, EMEA, Lonngren, Vioxx
Thomas Lonngren, the head of Europe’s medicines regulator the EMEA has spoken out about Merck’s withdrawal of Vioxx, saying the sudden announcement left no time to prepare healthcare professionals or patients.
Merck pulled its $2.5 billion blockbuster from global markets after a large-scale trial showed long-term use of the drug doubled the risk of heart attacks and strokes.
Merck was conducting a study of the drug’s potential to prevent the recurrence of colorectal polyps but was advised by the independent trial regulators to stop the study. The company contacted the US regulator the FDA on 27 September to notify them of the trial being cut short, and then informed the agency of its voluntary withdrawal of the drug at a meeting the next day.
The swift communication in the US seems to have been in contrast to Europe, where the EMEA says it was contacted just hours before investors were told of the withdrawal on the last day of September, and that it wasn’t until 4 October that company representatives met its officials.
Lonngren, speaking at the Financial Times Global Pharmaceutical conference criticised the way the industry communicates, saying: “Once again, history has shown we don’t have a sufficient system in place.
“More and better communication on the safety of medicines is the key, and here we are a little disappointed in the pharmaceutical industry, I would say, because they are focused more on the stock market sometimes,” said Lonngren.
“We are very concerned about that, because we want the company when they have a problem to communicate with the regulator and not to bother about the stock market first.”
The EMEA is currently conducting a comprehensive review of its operations, and recently completed a consultation with stakeholders including industry trade associations at national, European and international level, national authorities and academia.
The final ‘road map’ and implementation plan is due to be published before the end of this year, and is expected to include proposals on how the regulator can communicate more openly and frequently with the industry to anticipate problems with drug approvals and post-marketing surveillance.
Merck’s decision not to prolong doubts about Vioxx after the study and simply withdraw it has been praised by many, including Acting FDA Commissioner Dr Lester Crawford who said: “Merck did the right thing by promptly reporting these findings to the FDA and voluntarily withdrawing the product from the market.”
The FDA, already being investigated by the US Senate Finance Committee for its handling of safety data on the use of antidepressants in children has also been accused of suppressing evidence of Vioxx’s cardiovascular side-effects.
Dr David Graham, associate director for science in the FDA Drug Centre’s Office of Drug Safety has testified before the committee that he was persuaded not to present negative studies on the drug earlier this year.
Senator Charles Grassley outlined the testimony in a statement saying: “Dr Graham described an environment where he was ‘ostracised’, ‘subjected to veiled threats’ and ‘intimidation’.”
The FDA responded to the allegations by saying it “values open discussion and frank exchange about scientific and medical issues” and that its scientists are subject to “more rigorous” scrutiny than standard scientific peer reviews.
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