US trade body Pharmaceutical Research and Manufacturers of America (PhRMA) has become the latest industry organisation to comment on Dr Ben Goldacre’s book Bad Pharma, providing a clear sign of how far its message has spread.
PhRMA’s executive VP of public affairs Josie Martin said the book, which criticises the lack of transparency in clinical trial results, did not represent the clinical trial process.
“The book ignores that the current clinical trial system, which is essential to the development of new medicines that save and improve lives, is scientifically rigorous, tightly regulated and working well,” he said.
Bad Pharma’s claims “may attract attention, but they do not advance biomedical science or patient health,” said Martin.
He also took aim at the campaign for greater clinical trial transparency, of which Dr Goldacre and the British Medical Journal have been prime movers, saying their demands were “irresponsible with potentially harmful consequences for future medicine development”.
But Dr Goldacre told PMLiVE: “It’s very peculiar that asking companies to stop withholding the results of clinical trials should elicit such colourful denunciations. Industry should expect to make vast sums of money by selling drugs that are the best in their class. But there is no right to mislead doctors and patients, by withholding unflattering results on less effective medicines.
“We need to know what works, and how well it works, when we use drugs. That is uncontroversial, and I hope PhRMA will be able to engage in a serious discussion about this ongoing problem, as others in industry have happily done.”
Martin’s comments follow last month’s launch of the Alltrials.net campaign, which wants governments, regulators and research bodies to ensure all clinical trial results are published in full and has attracted a number of prominent supporters.
One of the drivers behind the Alltrials.net campaign has been the ongoing controversy around Roche’s refusal to release full clinical data for its flu medicine Tamiflu, despite concerns that it is no better than placebo.
Roche’s stance has also help fuel a debate in Europe about what information pharma companies should publish about clinical trials.
Last November, following a workshop attended by Dr Goldacre among others, the European Medicines Agency (EMA) said it intends to update its policy during 2014.
As in the US, such developments have attracted criticism from the industry in Europe, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) warning that an indiscriminate approach to transparency could harm innovation.
MEP calls for improved transparency
Meanwhile, there have been further developments to the clinical trials transparency debate at a European level.
The European Parliament lead’s legislator for the revision of the European rules on clinical trials, Glenis Willmot, has released a report calling for “wide-ranging transparency measures”.
Willmot, an MEP for the UK’s Labour party, said she wanted “comprehensive results from clinical trials published on a public database”.
She said: “A summary of the results is not enough. Summaries written by those that carried out the research can be biased, and make a medicine sound more successful than it really is.”
In addition, Willmot also called for financial penalties to be imposed on companies that do not make their results available on time.
”If we are serious about openness in medicine then we have to levy fines on those not following the rules,” she said.
Posting Willmot’s announcement on his blog Bad Science, Dr Goldacre said: “Patients around the world are very fortunate that she has been chosen for this position on clinical trials.
“It is very clear that she will be working hard to fix this broken legislation, and her initial report on the draft regulation demonstrates a clear recognition of problems that have been neglected for too long.”