Sarepta, eteplirsen: anecdote, data, surrogate outcomes, and the FDA

September 30th, 2016 by Ben Goldacre in bad science | 5 Comments »

The Duchenne’s treatment made by Sarepta (eteplirsen) has been in the news this week, as a troubling example of the FDA lowering its bar for approval of new medicines. The FDA expert advisory panel decided not to approve this treatment, because the evidence for any benefit is weak; but there was extensive lobbying from well-organised patients and, eventually, the FDA overturned the opinion of its own panel. There have been calls for paper retractions, and so on.

This is not the first time we’ve seen peculiar activity around the treatment. Read the rest of this entry »

My evidence to the Science and Tech Select Committee inquiry on missing trial data

April 26th, 2013 by Ben Goldacre in alltrials campaign, bad science, big pharma | 6 Comments »

The UK House of Commons Science and Technology Select Committee are currently looking at the problem of clinical trial results being withheld from doctors and patients (partly, the committee says, in response to Bad Pharma, which is heartening). A clear, thoughtful report and policy recommendations from this committee could be an important step towards fixing these problems.

I gave oral evidence this week on a panel with Roche, GSK, and the ABPI (who have previously tried to pretend that all the issues in Bad Pharma were “historic” and “long addressed”). I’ve posted the video below, and I’ve posted my written evidence underneath that. First is my submission addressing the specific questions posed by the Committee, and then my appendix, giving background on the problem of withheld trial results. Read the rest of this entry »

MPs write to Public Accounts Committee to request action on hidden trials and Tamiflu.

December 14th, 2012 by Ben Goldacre in ABPI, alltrials campaign | 8 Comments »

The letter below has been sent to Margaret Hodge, Chair of the Public Accounts Committee, asking her to take action on the ongoing problem of hidden trials, and specifically Tamiflu.

The very notion that we spent £500 million on Tamiflu – with information about over half of the clinical trials still being withheld – is nothing short of absurd. For context, £500 million is 5% of the total NHS drugs budget (£10 billion) for one year. This ongoing issue of secrecy around clinical trials wastes money and harms patients, and it has persisted for several reasons. Read the rest of this entry »

EudraCT, the clinical trials transparency tool held in secret

March 5th, 2011 by Ben Goldacre in bad science, big pharma, conflict of interest, publication bias | 17 Comments »

Ben Goldacre, The Guardian, Saturday 5 March 2011

The European Medicines Agency now regulate the pharmaceutical industry throughout the whole of Europe. In December 2010 Thomas Lonngren stepped down as their executive director. On the 28th of that month he sent a letter telling the EMA management board that he was going to start working as a private consultant to the pharmaceutical industry, in three days time, on 1 January 2011.
Read the rest of this entry »

Give us the trial data

August 14th, 2010 by Ben Goldacre in bad science, big pharma, libel, publication bias, regulating research | 47 Comments »

Ben Goldacre, The Guardian, Saturday 14 August 2010

This week the drug company AstraZeneca paid out £125m to settle a class action. Over 17,500 patients claim the company withheld information showing that schizophrenia drug quetiapine (tradename Seroquel) might cause diabetes. Why do companies pay out money before cases get to court?

Read the rest of this entry »

Pharmaco-epidemiology would be fascinating enough even if society didn’t manage it really really badly

July 17th, 2010 by Ben Goldacre in bad science, big pharma, bullying, publication bias, regulating research, trial registers | 22 Comments »

Ben Goldacre, The Guardian, Saturday 17 July 2010

This week the FDA voted not to ban GlaxoSmithKline’s diabetes drug rosiglitazone (brand name Avandia). Their vote has been reported as a victory for the company. I don’t think so: this saga tells an ugly story about our collective medical incompetence.

Read the rest of this entry »