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Breaking the seal on drug research

A band of researchers and activists is pushing the world’s biggest pharmaceutical companies to open their clinical trial records

Written by New York Times |
July 28, 2013 5:28:44 am

KATIE THOMAS

Peter Doshi is 32 and not sure where he’ll be working come August,when his postdoctoral fellowship at Johns Hopkins University ends. Even without a medical degree,he is one of the most influential voices in medical research today.

Doshi’s renown comes from pushing the world’s biggest pharmaceutical companies to open their records in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists,he is trying to unearth data from clinical trials and make it public.

There is an underdog feel to this fight,with postdocs and academics flinging stones at well-fortified corporations. But they are making headway. Last fall,drug giant

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GlaxoSmithKline announced that it would share detailed data from all global clinical trials conducted since 2007,a pledge it later expanded to all products dating to 2000. Although that data has not yet been produced,it would amount to more than 1,000 clinical trials involving more than 90 drugs.

In summer 2009,Doshi received a call from Dr Tom Jefferson,a British epidemiologist. That year,swine flu was spreading worldwide,and Jefferson had been hired by the British and Australian governments to update an earlier review of Tamiflu,a drug produced by the Swiss company Roche,aimed at reducing the flu’s severity. He asked if Doshi wanted to help.

So Doshi and his colleagues set out to answer a simple question about Tamiflu: Does it work? Resolving that question has been far harder than they ever envisioned,and,four years later,there is still no definitive answer.

Determining Tamiflu’s efficacy had significant economic as well as health consequences. Around the world,private companies and governments were stockpiling Tamiflu and their spending accounted for almost 60 per cent of the drug’s $3 billion in sales in 2009.

At the time,Doshi knew little about clinical trials. But he knew Jefferson. Jefferson had conducted a Cochrane review of Tamiflu’s effectiveness a few years earlier,concluding that the drug reduced the risk of complications from the flu. But just as their work was getting under way,a simple comment arrived on the Cochrane website that changed the course of the research.

The author of that comment,Dr Keiji Hayashi,had no connection to the Cochrane group. He was a pediatrician in Japan who had prescribed Tamiflu to his patients but had come to question its efficacy. He was curious about one of the main studies on which Jefferson had relied in his previous analysis. Called the Kaiser study,it pooled the results of 10 clinical trials. But Hayashi noticed that the results of only two of those trials had been fully published in medical journals. Given that details of eight trials were unknown,how could the researchers be certain of their conclusion that Tamiflu reduced risk of complications from flu?

In trying to answer the pediatrician’s question,Jefferson realised that there was a flaw: They relied too heavily on the assumption that the articles published in journals accurately represented the results of all clinical trials. Jefferson then approached Roche itself,asking for the underlying data from the missing trials. But Roche decided not to cooperate with the researchers.

Without more complete data about the clinical trials,the Cochrane group decided that it could not include the disputed study that summarised those results. In December 2009,the team reported that Tamiflu could not be shown to reduce complications like pneumonia or hospitalisations.

The British Medical Journal,which printed the team’s conclusions,also published its own investigation,showing that Roche had hired ghost writers to author articles involving Tamiflu and that those writers had said they were asked to highlight positive messages. Roche responded that hiring such writers was common industry practice,and rejected the idea that they had been pressured.

The group’s efforts seemed to make a difference: After the articles in the journal,Roche turned over partial copies of study reports,amounting to a little more than 3,000 pages. Then,in 2011,the European Medicines Agency turned over more than 22,000 pages of documents for 19 trial reports.

In April,Roche said it would make available to the researchers clinical study reports for all the trials of Tamiflu. Jefferson,Doshi and their colleagues hope to complete another update to their review of the drug by year-end.

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