UPDATED: Pfizer first on trial transparency
pharmafile | December 5, 2013 | News story | Medical Communications, Sales and Marketing | EMA, Goldacre, Pfizer, alltrials, transparency
In an industry first Pfizer will allow access to its clinical trial data for independent researchers and patients who participated in their studies from next year.
The world’s largest drugmaker said it hoped the enhanced access to its data will encourage further scientific and medical research, as well as getting more patients to get involved in clinical trials – something that has become increasingly difficult for pharma in recent years.
Pfizer research chief Mikael Dolsten told reporters at the company’s New York headquarters: “We think this is the right time to support this trend.”
This comes at a time when the industry is being put under pressure by groups such as the UK-based AllTrials campaign that is hoping to make pharma disclose all of its trial data for public consumption.
The European Medicines Agency is also looking from next year to increase the level of transparency from pharma, as it will start a new series of regulations designed to make companies release trial data to the public.
Some companies are fighting this move such as AbbVie and InterMune, who are both suing the EMA for releasing data on their medicines.
But others are less resistant like London-based GlaxoSmithKline that has signed the AllTrials campaign and set-up an online system to provide researchers with access to anonymous patient-level data about its medicines.
Similar moves by Leo Pharma are also in the mix as they are soon to start slowly releasing data from their trials dating back to 1990.
But Pfizer has gone a step further by allowing trial patients themselves to access its data. “We are proud to be, I think, the first company to take this step,” Dolsten said.
Under the new initiative, the company will make layman summaries of its trial results available to those who took part in the study, beginning next year.
Pfizer will also allow trial participants to download all of their own personal data gleaned during the study.
That would for the first time give patients access to personal medical information tracked by researchers over the course of the trial, which is far more detailed than simply their response to the study drug or placebo.
The information could help doctors and patients make more informed treatment decisions to address health problems, the company said.
“We’ve had patients ask for information for many, many years and I think one way of making them feel that the value that they brought to the whole development process is in fact recognised is to get information back to them,” said Steve Romano, head of Pfizer’s medicines development group and speciality care unit.
“As far as changing the mind-set of patients getting involved in clinical trials, which has always been a challenge, this will help quite a bit,” Romano added.
For the scientific and medical researchers, Pfizer said it would consider requests for access to its trial information and make the anonymous patient data available for what it sees as high-quality scientific reviews.
To enhance the transparency of the process, Pfizer will set up an independent review panel of academic scientists with the power to override a Pfizer veto or partial approval of clinical data access to researchers. The panel, not the company, would make the final decision, Pfizer said.
Pfizer plan contains ‘same loopholes’
But Dr Ben Goldacre, one of the founders of the AllTrials campaign and author of Bad Pharma, has told Pharmafile that while any forward movement from industry on transparency is welcome, this statement from Pfizer “contains the same loopholes that we have seen from industry for many years”.
For example, he says, the company exclude off-label studies – i.e., use of medicines outside of their licence for rare conditions or for children – from transparency, even though such uses are commonplace.
“In fact, Pfizer have received extremely large fines for promoting exactly this kind of off-label uses for drugs such as the NSAID Bextra (valdecoxib), antipsychotic Geodon (ziprasidone), pain drug Lyrica (pregabalin), urinary incontinence treatment Detrol (tolterodine) and anti-seizure medicine Neurontin (gabapentin), to date,” he points out.
Dr Goldacre argues that since Pfizer knows that these uses are commonplace, and they have promoted these uses themselves, then it ‘makes no sense’ for them to say that the trial data on these uses should be kept secret. It also makes no sense to exclude older trials: “Those trials are on the very drugs that we are using most commonly, right now, in everyday clinical practice.”
Lastly he believes that using just summaries of CSRs is ‘unacceptable’. He points to a recent PLoS paper from the German health technology assessor IQWiG that showed large quantities of important information on results and methodological shortcomings are only available in full CSRs. “That is why the AllTrials campaign calls for CSRs to be made publicly available,” he says.
“Medicine has changed, and there is an inevitable policy trajectory towards greater transparency,” he concludes. “Pfizer should show true leadership, and recognise that their loopholes inflict unnecessary harm on industry’s reputation.
“They should commit to sharing all results, on all trials, of all uses, of all medicines currently being prescribed. And they should join others in signing up to the AllTrials campaign, and help in driving transparency forwards throughout the sector.”
Ben Adams
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