[Ip-health] Who will be sued next? - Scrip editorial

[Ellen T HOEN]

High prices as a safety measure?





 21 March 2007 Scrip News


 Who will be sued next? - editorial


 Students of pharmaceutical marketing will have two case studies in their
 textbooks for years to come: Herceptin and Gardasil. The life-extending
 properties of these drugs are rightly celebrated as medical triumphs, but
 their commercial success may owe as much to people power as laboratory
 breakthroughs.


 Thousands of women with a particular form of breast cancer will be treated
 with Roche's Herceptin (trastuzumab) in the early stages of their disease
 in the next few years at great expense, even though the science remains
 quite fresh. Trastuzumab may become a tried and true remedy in certain
 indications over time, but popular demand for immediate access to
 Herceptin has caught regulators, clinicians and politicians off guard.
 Patients want it now!


 As reports of the HERA trials spread through the media, patient power
 overwhelmed all of the multifarious evaluation systems that have been
 established between the clinic and the market.


 UK patients took their demands for unauthorised trastuzumab treatment
 through the judicial system, suing local health authorities, and appeared
 on newspaper front pages equating denial of the drug with a death
 sentence. Patricia Hewitt, the Labour health secretary, took the patients'
 side, and the main UK health technology assessor (NICE) appeared to buckle
 under the pressure. NICE developed a new fast track, undertaking its
 ultimately positive assessment even before Herceptin had a licence.


 The European Medicines Agency appeared somewhat desperate to deflect
 criticism last year when it issued a statement saying it was waiting for
 Roche to make a marketing application, and that it was not withholding
 approval unreasonably.


 Patients worldwide want Herceptin. New Zealand baulked at the cost and has
 proposed funding a nine-week course of treatment, rather than the standard
 12 months, despite bitter criticism from Roche and opposition politicians.
 France said Herceptin could be used temporarily in the early-stage
 indication even before its marketing application was approved.


 Imagine, for a moment, that postmarketing studies reveal more serious or
 frequent cardiovascular side-effects for Herceptin than have been found so
 far. Will the same patients who instructed their lawyers to sue for access
 to the drug be instructing the same lawyers to seek compensation? And whom
 will they sue?


 The same issues arise for the first vaccine against cancer. Millions of
 young women may be able to avoid cervical cancer and genital warts for
 five years, perhaps forever, with three injections of Gardasil
 (quadrivalent human papillomavirus vaccine), developed in Australia by CSL
 and licensed to majors elsewhere.


 Australia's prime minister has determined that young women in his country
 will have it and the independent payer there has fallen into line, after
 an unspecified price cut. On another continent, the French government has
 been advised to fund the vaccine, and non-governmental organisations are
 clamouring for poor women everywhere to have access to Gardasil.


 The science is as sound as evidence-based medicine can be, but still
 fresh. The voices of the authorities whose job is to advise caution have
 been drowned out by popular sentiment.






______________________________________

Ellen F.M. 't Hoen LL.M.
Director Policy Advocacy

Medecins sans Frontieres
Access to Essential Medicines Campaign
8, rue Saint - Sabin
75544 Paris cedex 11
France

tel: + 33 1 4021 2836
fax: + 33 1 40212960
e-mail: ellen.t.hoen@paris.msf.org
www.accessmed-msf.org

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