Drug regulators are protecting profits over patients

A new study by the ever-resourceful British Medical Journal has found that medicine regulators are protecting drug company profits over the welfare of patients by withholding trial data.

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This is distorting the picture of how well a drug works, they say, as many negative trial results are left unpublished, tacitly protecting pharma companies.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This must be remedied, they say, and describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the EMA for marketing approval in Europe.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 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.

Something needs to change.

US pharma: more corrupt than you think

The pharma industry certainly has its fair share of corruption and just today Dr Jacques Servier, president of France’s second biggest pharma company Servier, has been forced to deny allegations that his company was able to keep a dangerous drug on the market because of his high level political friends.

But corruption in Europe is but a drop in the ocean compared to how the industry works in the US. For starters, drugs cost about double on the US market than in Europe because they know they will pay it – there are no HTA’s or cost-effectiveness bodies there (as the American right constantly shout down the use ‘death panels’) to check to see if a drug is worth the price, so pharma will push the cost as far as they can get away with.

This week, a new dodgy practice has come to the fore, as the Federal Trade Commission released its report on ‘pay for delay’ on generic drugs.

How it should work is that an R&D led company will develop a drug, sometimes with the help of a biotech firm, and if it passes all the necessary pre-clinical and clinical trials and is approved by a regulator, it will be the intellectual property of that company(ies) for around 12 years (depending on a number of factors) and is protected under patent.

At the end of its patent life, small generic firms will copy the patented drug and sell its own version for a much lower price – sometimes as much as 90% cheaper.

This will not need to go through clinical trials – the expensive element of pharma – as it has already been proves safe, and will pass through regulatory proceedings very quickly.

Basically, these companies are looking to make a quick profit and a quick turn around by forgoing the innovative process and banking on what they know works. But this also works out for patients as we can see significant savings on once pricey drugs.

This is also good for competition as it protects a company for a number of years, incentivizing innovation.

But the FTC has found that pharma companies are paying these generic firms to delay launching their cheaper versions in order to eek out more revenue from a drug.

And these can be big numbers - the statin Lipitor, the world’s biggest selling drug, has been making between $10 billion and $13 billion a year in global sales for nearly 14 years.

Its developer Pfizer will lose its US patent protection on the drug this November, meaning nearly all this revenue will be wiped off their books almost overnight by generic firms. If, however, it could pay those firms a few million dollars to delay making a generic version of their drug, they would be paying a small amount of money to keep those revenues for an extra year or so, artificially increasing its patent.

In fact the FTC report found, unsurprisingly, that firms paid by big pharma delayed the launch of their generic version by an average of 17 months, meaning that drug was priced artificially high for nearly a year and a half in the US, just so companies could make more money.

The FTC’s report also found that the number of these agreements has increased by more than 60 % - up from 19 in 2009 to 31 in 2010.

Overall, the deals reached in the latest fiscal year involved 22 brand-name pharma products, with combined annual US sales of about $9.3 billion.

The FTC’s chairman Jon Leibowitz didn’t pull any punches: “Collusive deals to keep generics off the market are already costing consumers and taxpayers $3.5 billion a year in higher drug prices,” he said.

As Leibowitz said: “The increasing number of these deals is a win-win proposition for the pharmaceutical industry, but a lose-lose for everyone else.”