Applied Clinical Trials
In the febrile atmosphere of Europe's debates on transparency, could there have been a worse moment for the recent allegations in the UK daily newspaper, The Guardian, that the drug industry is secretly pressuring patient associations to advocate restrictions on the release of clinical trial data?
In the febrile atmosphere of Europe's debates on transparency, could there have been a worse moment for the recent allegations in the UK daily newspaper, The Guardian, that the drug industry is secretly pressuring patient associations to advocate restrictions on the release of clinical trial data? Certainly, the European drug industry association, European Federation of Pharmaceutical Industries and Associations, has been caught a little flat-footed. EFPIA is still promising to finalize its long-awaited position on this highly contentious subject, but in the meantime it appears - even without a clear position - to have been urging drug firms to influence patient groups in any case to plead for caution in the current legislative and regulatory moves on data release. In addition, recent reports of questionable practices by European drug firms operating in China have done nothing to reinforce trust in the drug industry. And all the while, European discussions of anything related to trust and transparency are now heavily contaminated by the fall-out of the revelations about espionage.
But amid all the heat and dust, the central issue is at risk of being obscured. No matter how modish it is to assume almost universal drug industry guilt, the discussion of transparency over clinical trials merits more sober reflection.
It is not only the drug industry that argues for some caution in handling data. The European Medicines Agency, which has taken the lead in proposing wider access to data, describes its approach as "considered," acknowledging the need for balance between the competing claims of independent scrutiny, the protection of personal data, and the sensitivity of "legitimate commercially confidential information." The European Union's own data protection supervisor has also warned against injudicious processing of "sensitive data regarding health." Even the European parliament's health committee, which has won praise from industry critics for its hard-line proposals on data access (its views will be tested in the parliament as a whole in the autumn), acknowledges that access should be "without prejudice to the protection of personal data, and should respond to specific guidelines in order to define and guarantee good analysis practice, clinical trial data formats, rules of engagement as well as other legal aspects." And there is no shortage of eminent academics and clinicians who have publicly stated their concerns that extreme positions about making all data available to all comers have not been properly thought through.
The piece in The Guardian chooses to ignore much of the nuance in these important discussions. It states baldly that "Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects." It adds: "Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice." The vital distinction is omitted between releasing more data - which is unquestionably under discussion - and releasing all data - which is not.
The Guardian speaks of industry mobilizing "an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials." It cites at length prominent industry critics alleging the creation of " spurious problems," and a "hidden agenda" under which "patient groups will say they think it's a great idea to keep clinical trials data secret." And it quotes an unnamed "source in the European parliament," who claims to have been subject to "intense lobbying from patient groups". But two leading European patient associations have immediately rebutted the suggestion that they have been unduly influenced by industry. The European Aids Treatment Group, which openly admits it receives funding from drug firms, underline its clear policy of release of all clinical data relating to medical trials. It says it would like to know who the patients groups referred to in the newspaper article are. The European Patients Forum, which has a similar policy on data release, also said was unaware "of any bona fide patient group that would advocate another stance and would be interested to know which patient groups make up the ‘army’ being referred to in the article."
It is yet another episode that redounds to hardly anyone's credit. Exaggeration and simplistic discussion of complex issues are not constructive contributions to satisfactory policy making. But the European drug industry - so keen on developing an agenda around trust - has let itself be caught out, at the very least on timing. It might have drawn less flak had it published its position on data release and given it wide circulation before suggesting to member companies that they might also usefully seek to widen the debate among patient representatives too - an exercise in no way illegitimate. That omission has made the industry an easy target for critics delighted to portray it as some sort of conspirator in corruption. And patient associations, for long a victim of ambiguity over their financial links to the industry, have obviously still got a lot to prove about their independence of opinion, so as to be immune to imprecise suggestions of complicity. None of this is going to make the discussions in the European parliament, the European Council or the European Medicines Agency any easier - and that is what really counts in creating genuinely useful regulation.