PharmaTimes Head-to-Head Debate
Whitehead vs Goldacre
26 February 2013, 5.15pm – 8.00pm
So Pharma is not getting its act together?
First let me say that I’m delighted to be here this evening because it’s an opportunity to put the record straight. The pharma industry is not perfect ... no industry is. But we have been on trial for several months. The accusations have been a complete travesty of the truth. It is an attack on the credibility of the 67,000 colleagues in the UK who work hard and imaginatively to deliver great medicines to patients. It’s a betrayal of the confidence of the thousands of doctors, nurses and ethics committees who have been involved in running the hundreds of thousands of trials Ben dismisses as ‘flawed’. Possibly most important, it’s alarming to patients who may think the drugs they are given are not adequately tested. This is simply not true.
Let me turn this on its head. Without what the pharma industry has done... and is doing ... the NHS would not exist in its current form. We have made the untreatable treatable and enabled medics to do their jobs more effectively. We have given them the tools to meet patients’ needs wherever you care to look ... ulcers, coronary heart disease, HIV/AIDS, cancer, serious mental illness ... we have met one challenge after another. Imagine a world without us ... doctors and nurses could do nothing more than mop a fevered brow.
I’m tired of seeing my industry attacked by people who have an unwritten agenda. Yes there are examples of bad practice, but to claim they are the norm is like saying all doctors are like Harold Shipman, all nurses are like Beverly Allitt and all hospitals are like Mid Staffs. You could just as easily write a book called Bad Doctors or Bad Hospitals. It’s inaccurate, unrealistic and alarmist. Ben is a great agent for change, but I hope he will engage with us rather than polarising the debate ... and I personally have no reason not to welcome his contributions. However, it’s important to realise that we were engaged in the journey towards transparency long before Ben published his book.
The title of this debate is “Pharma is not getting its act together”. I find that insulting. It suggests there was an act to clean up, when in reality we have been leading the way. It paints the pharmaceutical industry as cartoon villains in a world which is technicolor, complex and 3D.
All industries have become more transparent in line with societal expectations, and pharma is no exception ... along with the rest of medicine. I had a friend who in 1985 was diagnosed with cancer and not told he had cancer! That would be completely unacceptable now. There are examples of increased transparency and scrutiny everywhere you look ... the BBC inquiry into the Saville affair, or Leveson ... the Facebook debate on privacy, Mid Staffs ... MP’s expenses. Society rightly expects transparency and we as an industry have moved with these expectations. Transparency is the friend of knowledge!
Despite the attempts to demonise, marginalise and ridicule us, the pharma industry in fact recognised the changing demands of society in the data driven world a long time ago.
Put simply, we were on this journey before Bad Pharma was a twinkle in Ben’s eye!
Now I like Ben and I think he is a brilliant agitant and advocate for change and a successful one, but he is also selling a book!
There is a propaganda technique known as ‘The Big Lie’. It refers to a lie so huge that people will believe it because they don’t think anyone would be brave enough to make it up. I want to address the Three Big Lies that have been bandied around this debate.
One: It is not correct that 50% of trial data is unpublished. The FDA challenged this statistic and their own research showed the true figure was that 78% of trials which met the criteria for mandatory registration had been registered and had results posted on www.clinicaltrials.gov. The ABPI has done its own research across the EU and found that the figures were broadly in line with the FDA’s 78% finding for new products approved in 2010 and 2011. That’s not perfect, and we aim for 100%, but it’s very different from 50%. I accept that this is not historic data but it balances the debate.
Two: The regulators see every scrap of safety data as part of the approval process, whether it’s publicly available or not. The role of the regulators has been forgotten in this debate. We have very strong regulatory process which ensures safety and efficacy of medicines, and a quick, robust and effective process for reporting adverse events.
Historically the regulator was always the law – unquestioned, accepted and adhered to totally. As the world changes in its expectations this too will change but I want a world with a strong regulator at its core. I find it fascinating during the whirlwind of publicity that the regulator has barely issued a comment. I want to suggest that they see this as a work in progress rather than a problem to be solved like breast implants or joint replacements.
Three: Pharmaceutical companies do not compare their drugs with weak comparators. In fact pharma companies don’t design trials alone ... the process involves liaising with medical experts and regulators, the protocol has to adhere to current treatment guidelines, approved by the ethics committee ... and then doctors have to agree to try and recruit patients onto it. If the trial is a success ... and many are not because this is a high risk business ... the company developing the drug then has get reimbursement for it ... and we have very tough reimbursement authorities. They would not approve funding for a drug if it had not demonstrated efficacy against a meaningful comparator. Placebo controls are sometimes relevant and necessary, and are demanded by some regulators in some conditions.
Let me go off-piste here for a moment and talk about the Alltrials petition. We are committed to greater transparency in reporting the occurrence and results of clinical trials. We agree that summary clinical trial results should be made available for both new and existing medicines ... However, the mechanisms for doing so are still being finalised. The Alltrials petition is one of a number of initiatives which are currently addressing the issue, but there are others which we are involved with ... for example, the EMA work streams and the House of Commons Science and Technology Committee inquiry. The ABPI code itself is under constant review. There should be no doubt that we are committed to greater transparency as an industry. We are all moving in the same direction. What is at issue is the way of getting there, and the eventual destination. It’s not perfect and we welcome considered criticism ... it helps maintain the momentum on the journey.
However, we will not respond to PR-driven initiatives such as Alltrials. We need considered, thoughtful discussion which will lead to sustained, long-term solutions to a difficult problem. I recognise the value of Twitter as a campaigning tool but this issue cannot be summarised in 140 characters ... we will not engage in that way.
So I want to talk about Good Pharma. Not Perfect Pharma by any means. But Good Pharma. When I look at the developments in health and wellbeing, life expectancy and quality of life, I see that the pharmaceutical industry, with its medicines and vaccines, is responsible for a large chunk of that progress. Vaccines alone have prevented more death and disease than anything except the provision of clean water. Smallpox has been eradicated. Polio is virtually gone in the developed world.
I look at friends with diabetes or HIV whose lives have been transformed by medication. Our member companies – my industry – are working on better treatments for dementia, multiple sclerosis, rare genetic disorders like Cystic Fibrosis, vaccinations against meningitis and many childhood diseases. In the past 10 years alone, approximately 350 new drugs have been approved that offer hope to people with hard to treat diseases. Diseases that used to be killers no longer carry that threat. Leukaemia, if diagnosed early, can be driven into remission with a once-daily treatment. Cardiovascular disease, which not many years ago often resulted in bypass surgery, can now be managed easily with tablets. Improvements in cancer treatment have cut annual death rates by half.
As well as the value to individuals, the industry also has a great value to society. It keeps people in work and out of hospital. That alone puts the industry’s value balance sheet in profit. For every dollar spent on prescription medicines in the US, more than two dollars are saved in hospitalisation costs. Every 24 dollars spent on new medicines for CV disease saves 89 dollars in hospitalisation costs.
There is no doubt in my mind that my industry provides tremendous value to individuals and society. Is it perfect? No. Do we need to improve? Yes. Are we making progress? Yes. But let’s not deny the massive contribution we make.
Ben and Fiona are on record as criticising the ABPI for being inadequate in our response to the issues raised in Bad Pharma. Let me say one thing very clearly ... if we got anything wrong in our initial response then I’m truly sorry. It may be that we were caught unawares by the willingness of all parties to simply define the transparency issue as one of data release, and give the impression that they were making us aware of it for the first time. The reality is that we have been working on it for at least a decade. 10 years ago the ABPI code said nothing about transparency in clinical trials ... and I know Beat is going to talk more about that. Today, there is a requirement for all companies to register a trial within 21 days of the first patient being admitted, and to post the results within a year of the drug being granted marketing authorisation. We are in favour of transparency when it furthers research.
Ben claims these rules are not being adhered to. We do accept that compliance with them was never properly monitored, so we’re going to change things. We are announcing tomorrow that we are putting in place an entirely new process for monitoring compliance with the requirements to post details of all trials.
But the issue of transparency is wider than clinical trials, as Ben points out in his book ... and we’re also addressing the bigger picture. For example, from this year, pharmaceutical companies will have to disclose how much they pay to physicians in aggregate. We’re working with the healthcare community to agree a system of disclosure of individual payments by 2016. This is a huge and complicated process. Payments to patient organisations already need to be publicly declared. Medical Education Grants have had to be disclosed since last year.
So let’s look to the future. It’s crucial to understand that the UK is just a tiny part of the whole clinical trials picture, and people who are pressing for change need to acknowledge that. In fact only 1.6% of patients in global trials come from the UK ... down from 6% in 2000 .
Accepting the important role of commercially run trials we do need to continue to meet the changing demands of society regarding data transparency and work with our stakeholders, not against them.
Now let’s look at the vexed topic of releasing historical trial data. We’re planning a high level workshop with all stakeholders, and are already talking to Ben about his involvement. One challenge here ... and this is exactly the kind of thing that cannot be summarised in a tweet ... Ben has said in the past that he never asked for what’s called ‘patient level data’. But he has asked for the publication of full CSRs, but they include patient level data throughout. It’s not just a case of taking out the appendices ... the patient data is threaded through it. GSK said that their own plan to publish CSRs will take many years of work from a dedicated, skilled team. That’s why they’re going to do it in stages, prioritising the most widely-used drugs. Most companies don’t have the resources of a GSK ... so you can see what a huge undertaking this would be. We need to think whether the cost and effort of old and readily understood medicine is worth all this.
This is a hugely complex matter, and needs to be done in a way that still protects patient confidentiality and safeguards the commercial model of research. Assuming we can agree, the report will feed into an EMA workstream on the topic, and ultimately go out for consultation. This is a significant initiative. Ben, this is not the what it is the how!
We can achieve nothing as the ABPI alone. The ABPI cannot work in isolation. The issue of transparency in clinical trials is one that affects many people ... patients, obviously, but also physicians, researchers, pharmaceutical companies and governments, who want to ensure the medicines they pay for are safe and effective.
We are, therefore, working with our member companies and experts participating in the EMA's working groups on a real, effective and practical solution for old and new trials. It is vital, however, that we protect patient confidentiality and do not institute measures that will be disproportionately detrimental to clinical research in the UK or EU. This is particularly challenging for clinical trials for existing medicines, where there are issues around patient consent and ownership of data.
I said at the start that I didn’t recognise the picture of my industry painted by Ben. The industry employs 67,000 people in the UK. They work incredibly hard and ethically to get innovative medicines to patients. Medicine is not ‘broken’ as Ben claims, and as you say yourself, Ben, the pharmaceutical industry is responsible for saving lives ‘on an epic scale’. I wanted this evening to talk about Good Pharma. Not Perfect Pharma, but Good Pharma.
A Good Pharma that has proven its flexibility in responding to the changing demands of society, including transparency demands.
A Good Pharma that invests billions at risk, to meet unmet medical need.
A Good Pharma that will partner with friends and critics alike to address concerns.
A Good Pharma that will continue to play a major role in meeting the healthcare challenges of tomorrow. Ben is an agent for change. So is good pharma. Let’s work together!!