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This is distorting the picture of how well a drug works, they say, as many negative trial results are left unpublished, tacitly protecting pharma companies.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This must be remedied, they say, and describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the EMA for marketing approval in Europe.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

NHS Behind the Headlines: the only health resource you should use

NHS Behind the Headlines is a little known, under-used resource that should no longer be behind the headlines, but be the maker of them.

It overseen by Professor Sir Muir Gray, chief knowledge officer of the NHS, who is probably the most knowledgeable man I have ever seen on all aspects of health journalism.

Essentially Gray will write up the real story behind a messy, inaccurate and exaggerated health story you may have seen in the Daily Mail, Sun or Express (the usual suspects) the day after it has appeared on their sites/in print.

To be honest, I think we all should cut out the middle man and go straight to Gray, using the tabloid version as a reference, and then look at the primary sources (which are more available than you think) from which they are both working.

Yes it takes more time, yes it is less convenient, but then that’s the truth for you. If you want to know whether X drug/animal/food source will actually kill or cure you, it’s surely worth the extra effort.

The Department of Health media office is full of ignorant unhelpful drones

It’s true. If any of you have ever had the misfortune of trying to get hold of any information, however small or trivial or well known, you will know how soul destroying it is to talk to these people.

There has been a worrying trend over the years of media offices becoming less and less helpful, delegating their responsibilities to external PR companies and simply redirecting you to them if you have a query.

The DH of course can’t do this, but they are infested with willfully ignorant drones that either refuse to answer your question or have plausible deniability over its answer. Just this morning I asked a fairly straightforward legal question on the interaction between pharma companies and GPs – it wasn’t answered but rather – and this is a common theme – I was told to repeat my question slowly so the media officer could write it down, then asked for my email address for it to be replied to.

My deadline was four hours ago, as I told them – still no reply. And this is a quick legal question that they should really know off-hand. It is annoying, but I think it is more sinister than this. The government is allowing the DH to deliberately frustrate the media with vagaries, lack of comment or no comment at all. Next time you read ‘a DH spokesman said’ really look at the quote and see if it actually answers anything relating to the crux of the story. I will guarantee in 90% of cases, it won’t.

Why is this block on information allowed? Another example: Last week I rang up about the health reforms. There is currently a ‘listening exercise’ going on for about three months on the health reforms where everything will be put on hold so the government can hear about how much it will fuck the NHS. I see the Guardian is at an event so I ring the DH for future ‘roadshows’ that are expected to take place across the country. I get told categorically that the media will not be given a list of events of places and will simply have to use releases for any stories.

This is ludicrous – I do not wish to regurgitate a piece of poorly written DH propaganda on how amazingly well the roadshow is going. I want to talk to Lansley, Cameron and co. myself and get the mood of the thing – all the things a press release cannot give (and what is killing modern journalism).

UPDATE: I have found the list for the 'listening exercise': http://www.regionalvoices.net/2011/04/nhs-future-forum-listening-events-programme-hosted-by-regional-voices/ - however, press still not allowed. Apparently they just want to listen, not be asked anything...

Pharma plays dirty with covert attack on GPs

The pharma industry does not like to directly come out against ideas it knows will hurt its commercial interests – this makes it look bad and can be detrimental when negotiating with governments/ health bodies. So, what it tends to do is covertly use a body which it funds or has managed to get on side to do the dirty work for it.

There are a number of cases where this has happened – one of the more recent being over the new ways in which drugs are to be priced (watch this space for a later blog).

I received one last week, from a PR company, of course, that quite literally stunned me with its vociferous tone and blatant bias.

The group – the European Alliance for Safe Medicines (EAASM) – has been around for a while and was, until last week it seems, focused solely on anti-counterfeiting for branded drugs in the EU.

It is unsurprisingly funded predominately by pharma including Pfizer – the world’s biggest pharma firm – Eli Lilly and Novartis.

Off label

Now, however, it has turned its attentions to off-label prescribing to combat the ‘institutional malpractice’ it feels is in governments allowing the practice.

Off label prescribing is a practice that allows GPs to prescribe a drug for a condition it is not licenced for, even if there is a branded drug that is licenced to treat the condition.

This is predominately about cost, and the report alludes to the most common use of off label prescribing - i.e., the use of Roche’s cancer drug Avastin as an alternative to Novartis/Roche’s wet AMD drug Lucentis.

Wet age-related macular degeneration (AMD) is the leading cause of blindness in the UK for the over 50s and Novartis’s Lucentis is licenced in the EU to treat the eye disease.

However, it costs £10,000 per eye, per patient. Avastin, on the other hand, costs only £250 per eye, per patient and some limited research has suggested it is as safe and effective as Lucentis – this is why nearly half of all UK GPs will prescribe Avastin over Lucentis.

Both drugs are almost identical in their modes of actions (anti-VEGF) and both were originally developed by a biotech firm called Genentech, now a wholly owned subsidiary of Roche. 

So why doesn’t Roche seek its own marketing application for Avastin for use in wet AMD? Because it is the marketing partner of Novartis for Lucentis, meaning it gains a fair share of the £10,000 per eye per patient – it will not be looking to undercut itself by using Avastin.

However, in an unprecedented move, the Department of Health has asked the cost-effectiveness body NICE to look at allowing Avastin to be used off label in this way and trials are ongoing in the US and UK to fully understand its benefit/risk ratio in this context. If successful, both countries will most likely look to use Avastin off label for wet AMD.

Roche/Novartis are not happy.

GMC to make new plans

To further corroborate this, the UK doctors’ regulator the GMC last week announced a consultation on whether GPs should be able to consider cost when prescribing a drug off label – the GMC feels it should as it costs less and, as long as it is safe and effective, will do the same thing for patients that a licenced drug does.

I spoke to the GMC and they told me they are looking to update their guidance as a result of queries from doctors and medical directors, particularly relating to Lucentis/Avastin and the treatment of aged-related macular degeneration.

“The volume and cost of medicines prescribed in the NHS has soared in recent years,” the spokeswoman told me.

“Doctors can make substantial savings for the NHS by following NICE guidance on cost-effective prescribing that could be reinvested for the benefit of patients.”

In a remarkable coincidence, the EAASM suddenly became all concerned about off label prescribing when this consultation was announced.

It has said that off label use will have ‘very serious consequences’ and believes ‘regulatory vagaries and loopholes’ are allowing these practices to continue, which they say will be to the detriment of patients.

On the specific allusion to Lucentis/Avastin, the report implied that using the latter as an off label option could produce ‘horrifying adverse events’, including blindness and an increased risk of stroke.

It does not mention or reference any clinical trials, but refers to a number of unsubstantiated ‘newspaper reports’ detailing these adverse events – we’re not able to check them and, why would we believe a newspaper report over a clinical trial?

We will have to wait until ongoing trials bring back the results, but be under no illusion - it is a downright lie to say that using Avastin can cause blindness and other events when this has not been verified through the proper channels.

This is being said to distort the GMC’s attempt to cut costs and allow GPs a more liberal approach in prescribing and is being done in an underhanded, nasty way by the pharma industry, solely to help protect their commercial interests.

Business as usual then.

The Secret Raven

The ‘secret raven’ is a term littered throughout Franz Kafka’s letters to his Milena, his last love, before he died in 1922. The secret raven represents the fears and obsessions that stalked him throughout his life.

It is the title of this blog because the raven is what many health journalists are using against us – our own fears of cancer and pandemics, sickness and death – in order to sell their newspapers.

I am a journalist working for a well-known pharmaceutical trade magazine and I come across misinformation from health journalists and, more scarily, the pharma industry on a daily basis.

Given the nature of my publication, I cannot always publish the full truth and, even if I could, it would be read predominately by pharma – an industry that has no wish to read about its own shortcomings.

This is why I would send off the more interesting – and downright scandalous stories to blogger whistleblowers. The last time I did this was with Dr Ben Goldacre who, although happy to take on the story, suggested I was better placed to write up the individual occurrences of bad pharma and bad health journalists.

So here it is, a blog about bag health journalists and bad pharma from an insider.