The BMJ researchers say despite the existence of hundreds of thousands of clinical trials, doctors are unable to choose the best treatments for their patients because research results are being reported selectively.
This is distorting the picture of how well a drug works, they say, as many negative trial results are left unpublished, tacitly protecting pharma companies.
Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark believe this use of selective reporting can have disastrous consequences.
They give the example of Merck’s Vioxx (rofecoxib) that is thought to have caused around 100,000 unnecessary heart attacks in the US alone.
They also point to the older generation of anti-arrhythmic drugs that they say have potentially caused the premature death of about 50,000 Americans each year in the 1980s.
Struggle for access
This must be remedied, they say, and describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the EMA for marketing approval in Europe.
“The information was important for patients because anti-obesity pills are controversial,” say Gøtzsche and Jørgensen.
“People have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been de-registered for safety reasons.”
The authors contacted the EMA but the regulator refused access to the clinical trial data for the drugs, arguing that this would undermine commercial interests and that there was no overriding public interest in disclosure.
The authors contacted the EMA but the regulator refused access to the clinical trial data for the drugs, arguing that this would undermine commercial interests and that there was no overriding public interest in disclosure.
The authors appealed to the European ombudsman, who criticised the EMA’s refusal to grant access, forcing the regulator to widen public access to documents.
“There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients,” say Gøtzsche and Jørgensen.
They are now calling on other drug regulatory agencies to follow suit and suggest that access to documents should be made quicker and easier for scientific scrutiny.
“Drug agencies should get rid of the huge paper mountains and require electronic submissions from the drug companies, including the raw data, which should also be made publicly available,” they conclude.
Long-standing problem
This is not the first time that BMJ researchers have called for greater access to information from the EMA.
In October last year German researchers unearthed a mountain buried data from Pfizer’s antidepressant reboxetine that suggested the drug was ‘ineffective and potentially harmful’.
They believe this conclusion had been hidden from doctors because the EMA didn’t publish all the data it was sent, and called on the regulator to make publication of all trials mandatory to stop this from happening again.
All known trial data sent to the EMA must be published – it is that simple. By restricting access to information doctors and patients are half blind to what a drug can actually do to them, and is no exaggeration to say that the EMA really is putting pharma profits ahead of patients’ lives.
But the regulator is making some limited strides towards openness and in March this year, the EMA launched its new clinical trial database to allow greater public access to trial data.
However, it has done this under protest and under great pressure. Last year in fact I attended a meeting of the EMA called TOPRA and called on the then head of the EU regulator to explain their actions on a dangerous diabetes drug Avandia that they had allowed to stay on the market for years after it was shown to be unsafe.
The EMA refused to discuss Avandia (even though this was a meeting to talk about it processes and its future) and eventually asked me to leave the meeting after I refused to sit down and shut up.
The man I was talking to, Thomas Lonngren, is the same man who Ben Goldacre wrote about recently, who went from working for a regulator to working for a pharmaceutical consultancy to help them get through the regulatory process.
These are the people who are telling you what’s safe – they should be beyond reproach and committed to openness, and they are not.
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