Open letter to prime minister David Cameron and health secretary Andrew Lansley

@article{Nicholl2010OpenLT,
  title={Open letter to prime minister David Cameron and health secretary Andrew Lansley},
  author={David Joseph Nicholl and David Hilton-Jones and Jacqueline A Palace and Sam Richmond and Sara Finlayson and John B. Winer and Andrew Weir and Paul Maddison and Nick Fletcher and Jon Sussman and Nicky Silver and John Nixon and Dimitri Michael Kullmann and Nick Embleton and David Beeson and Maria Elena Farrugia and Marguerite Hill and C. Mcdermott and Gareth Llewelyn and James Leonard and Michael Morris},
  journal={BMJ : British Medical Journal},
  year={2010},
  volume={341}
}
Neurologists and paediatricians call for action on “massive” rises in the prices of orphan drugs 
Viridian Pharma replies
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In their open letter Nicholl and colleagues say that caffeine treatment for apnoea of prematurity has been subject to “massive” price rises in …
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Something is fundamentally wrong with a drug regulatory system that makes it increasingly difficult to do independent pragmatic trials of widely used but unproven drugs yet licenses a ridiculously
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There are inaccuracies in the open letter of Nicholl and colleagues that cannot be substantiated by evidence since 3,4-DAP has not undergone systematic safety and toxicology testing nor does it have appropriate safety monitoring and pharmacovigilance systems in place to capture, analyse, and report such data.
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The authors propose the development of a new assessment system based on several evaluation criteria, which would serve as a tool for Member State governments to evaluate each new orphan drug at the time of pricing and reimbursement.
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References

Pricing of orphan drugs