New Petitions

Thank you. I am here to present a petition that calls on the Scottish Parliament to urge the Scottish Government to implement a sunshine act that makes it mandatory for all payments, gifts and hospitality from the manufacturers of drugs, nutritional supplements, medical devices and healthcare technology to NHS Scotland healthcare workers to be reported and logged and for the information to be kept in a public, open database. The database should also include all sponsored education of healthcare workers and managers and should quantify the sums of money, or the cash equivalent of payments in kind, that are involved. I believe that the Scottish Government could lead the way in the UK on the issue.I will give a bit of background. My son has had type 1 diabetes since the age of 12 and is on insulin. I am very much an evidence-based doctor, and with reference to that I want to make it clear that I fully support the pharmaceutical industry. Indeed, one of Scotland’s undeclared heroes is Dr Macleod, the co-inventor of insulin, who got the Nobel prize in 1923. Another of our great scientists and one of my heroes is James Clerk Maxwell, without whom we would not be able to communicate in the way that we do today.Conflicts of interest feature daily in the news and occur in many different areas, as we all know, and healthcare should not see itself as immune from them. In the 1970s, the academic Robert K Merton commented on the loss of disinterestedness, and it has become a much-discussed problem in scientific journals. He was interested in the ways in which the cultural structure of science guarantees scientific objectivity. My main point today is that I believe in evidence-based science and I want it to be as objective as possible. Disinterestedness is the assumption that scientists are not influenced by personal material gain and that their reward lies in recognition by their peers. I suggest that the situation has changed significantly in the past few decades.I have been looking at the area for a few years now, and I have been confused about what regulations and guidance exist. When I initially contacted the Scottish Government, I was told that NHS boards should follow “A Common Understanding 2012—Working Together For Patients: Guidance on Joint Working between NHSScotland and the Pharmaceutical Industry”. However, that document, which I was forwarded by the Scottish Government, makes it clear that it excludes research, procurement and sponsorship. It therefore excludes quite a lot. Within the document, the reader is directed to NHS circular MEL—management executive letter—48 of 1994, entitled “Standards of Business Conduct for NHS Staff”, which is 20 years old. 10:30

I wrote again to the Government and on 31 October I had a helpful reply from Cabinet Secretary for Health and Wellbeing, who told me:“HDL (2003) 62 made it clear that all Health Boards should establish a register of interest for all NHS employees”.The key word there is “should”. Here we have two pieces of guidance, one of which is 20 years old—pre-devolution—and one of which is 10 years old. Alex Neil went on to say:“In addition, healthcare professionals will continue to be bound by the codes and standards of their regulators and professions.”The current Scottish appraisal form for consultants and doctors asks doctors to confirm annually that they have“complied with the conflict of interest mechanisms of the Boards”within which they work.That leads me to the research that I have done using the freedom of information legislation. I found that none of the 22 NHS boards in Scotland has a completely open-access, routinely populated, central register for recording interests as per the guidance in a health department letter of 10 years ago. A few boards have a register but completion is patchy. The board closest to the request in HDL (2003) 62 stated that“the information is not routinely collated”.The rest of the boards do not have routine collation of the details either. Basically, we do not know which doctor gets paid what, and there is no way of finding out.Last year, for the first time, it was revealed that, throughout the UK, £40 million was paid to healthcare workers by the pharmaceutical industry. It has been estimated that £4 million of that was paid to Scottish healthcare workers. That does not seem to appear in the existing registers in Scotland. My concern, as an evidence-based doctor, is about maximising benefit and minimising harm; my concern is also that resources should go where they are most needed in medical care. I will finish on harm. “I think the scale of this might slightly amaze you”.That is a quote from Dr Ben Goldacre. A recent report in the British Medical Journal said:“Three quarters of guideline panellists have ties to the drug industry”.A recent study by the ethical standards in health and life sciences group concluded that “89% of 1056 respondents agreed that payments to individually named healthcare professionals by companies should be transparent”.That is important, because much of the continuing medical education in the UK and Scotland is led by key opinion leaders. I became interested in the issue through working with our vulnerable elders in the area of dementia. The United States has a sunshine act, and France and Australia seem set to follow. Harm comes from the misleading promotion of continuing medical education and products. My wife and I, who have both been NHS medical practitioners for 20 years, went through the British national formulary for examples of misleading drug marketing where the potential for harm was underestimated. In every chapter, we found obvious examples. That is the result of marketing education—rather than scientific objectivity—where benefits are maximised and harm is not fully represented. The sum of £4 million may not seem a lot in relation to the budget for medicines. However, given the inverse care law, if we are seeing repeated examples of harm, those who most need it will not get the treatment that they should be getting, based on objective science.It is important that I conclude with a few examples. I wanted to cover all areas, and while my area of expertise is in psychiatry, particularly in relation to our elderly, my wife is a general practitioner. Each of these is an example of where a drug has been promoted through the involvement of the pharmaceutical industry, with the benefits being promoted first and the harms having appeared later.Chapter 1 of the BNF is on gastrointestinal disorders. Cisapride was most commonly used for gastro-oesophageal reflux, including in infants. It was withdrawn from the market in 2000 because of the risk of cardiac arrhythmia. Chapter 2 deals with cardiovascular issues. There is a very recent example. The new oral anticoagulants are said to be safer than warfarin. Extra warnings have now been issued as the drugs still increase the risk of bleeding and, unlike warfarin, have no antidote.Chapter 4 is on issues of the central nervous system. There are so many examples that it would be impossible to list them all. They include paroxetine, reboxetine and pregabalin. Pregabalin is a painkiller that has been widely promoted, with big awareness campaigns and lots of educational meetings about neuropathic pain. These drugs are now commonly sought for abuse.I am just about finished, convener. In relation to chapter 5, overuse of antibiotics and appropriate use of antibiotics might well be another area where there is an issue. Most people will probably be aware of the debate on Tamiflu, which shortens any influenza illness by only half a day and probably risks making people sick. Huge quantities of unpublished data on that have still not been released.Chapter 6 is on the endocrine system. On glitazones for diabetes, there has been a marked number of educational meetings. However, their use has now declined, because of the association of glitazones with heart failure and bladder cancer. On hormone replacement therapy, when long-term studies demonstrated that its proposed cardiovascular benefits appeared in fact to be harms, marketing of the products virtually disappeared overnight. The marketing bill for the pharmaceutical industry is twice the amount that it spends on innovation.I have just three more examples, convener. Chapter 7 is on obstetrics and gynaecology. I have come across oxybutynin, which is used for urinary frequency and incontinence but which has now been shown to have a risk of cognitive impairment, especially in the elderly, and that fact is now being used as the basis for marketing other, newer still-under-patent drugs of the same class.The drug Vioxx was used for musculoskeletal and joint disease but was withdrawn from the market. Following that, a rival firm was quick to push its product Celebrex, although significant warnings are now attached to its use. That class of drugs was marketed as causing fewer gastrointestinal side-effects than older drugs, but they had increased cardiovascular risks. The scandal that arose because trials had shown that to be the case but were not published led to the first steps towards the sunshine act in the USA.I will finish there. I am absolutely not arguing that we should outlaw conflicts of interest, which are part of life; I am arguing that we should insist on transparency. I believe that sunshine is a powerful disinfectant. There are a number of ways that we can go about this, but Scotland could lead the way by introducing a sunshine act.

I am definitely not an expert on that, but I am aware that, since August this year, America has implemented a sunshine act. Stories are now emerging online, because it is now mandatory that payments to doctors, particularly key opinion leaders, are published in an open-access database. Indeed, anybody can look that up on the “Dollars for Docs” website. The amount of money that is involved is staggering. That applies not to healthcare professionals across the board but to a number of individuals who are targeted as key opinion leaders and who are paid significant sums. If we follow the stories on each of those key opinion leaders, we find that, although there are benefits from the medication concerned, there has been underreporting of the harms.To return to Scotland, the main issue is that sponsorship by the pharmaceutical industry is the mainstay of continuing medical education once people have graduated as doctors. The medical profession has the notion that we can be more objective and rise above the potential for marketing, but I argue that scientific objectivity should be presented first and all that data should be available. We should know about the conflicts of interest. Those should be open and it should be mandatory to record them annually. We need action on several levels, and not just a sunshine act. We also hope to convince the General Medical Council that the issue could be a regular part of its appraisal system so that doctors record any payments or sponsored education of any sort.

No, I am not suggesting that, and I do not know much about that act. I am merely commenting that the evidence in recent freedom of information returns from all 22 NHS boards in Scotland is that transparency is talked about but is just not happening.

That is a good question. It would be relatively straightforward; indeed, I am surprised that it has not happened already. We just need an open, central register on which payments from the pharmaceutical industry are recorded. We all understand that conflicts of interest go far wider, but such a register would be the starting point. America has decided that that is the right route and the fact that France and Australia are considering it too says a lot.I have a copy of the ABPI’s helpful reply to the committee, but we cannot rely totally on outside agencies ensuring that a register is set up. The letter provides a lot of information on a European disclosure code but, having read it, I am not convinced that that will meet the standards of a sunshine act. We need the sunshine act as the background; we also need the GMC to regulate across the UK to ensure that an open register is used. That would be good for us all.We could tackle the inverse care law by ensuring that our medical prescribing resources go to those who most need them. We have so many lessons on overprescribing from history—even in my short time in medicine. I believe in the use of antidepressants and antipsychotic medications, but I want them prescribed appropriately to those who are most in need, and the risk is that that will not happen if education is marketed. The benefits are presented while the harms are not, and usually there is a combination of those.

That is a good question. We should have both. MEL 48 has been around for 20 years, so it is pre-devolution. It says that NHS boards should have a hospitality register, but they do not. That letter was issued two decades ago. Just recently, the Scottish Government finally confirmed to me the existence of another piece of guidance—HDL (2003) 62, which is headed “A Common Understanding”. That health department letter was issued 10 years ago but we still do not have functioning hospitality registers. That is shocking.NHS boards should be working with the pharmaceutical industry now. Any moves towards a national collective database can happen in addition to that. I do not see any problem with that.

Not at this stage. The register that I envisaged was only for NHS healthcare workers. However, it needs to apply across the board, so you make a good point.

Yes.

I am just a doctor; I do not know about costs.

The starting point is just payment or payment in kind. I think that that is relatively straightforward, not controversial, and in the spirit of transparency and objectivity.

How come in the Houses of Parliament scandal about payments transparency was seen as—

Absolutely. The potential for harm is significant, as has historically been shown by repeated overprescribing of medications, which has caused a lot of harm and has diverted resource away from people who need it. I do not see why you think the introduction of a register would be a problem.

No. I do not accept your argument at all.

No. I make it very clear in my petition what I am asking for, which is for payments to be recorded. America has accepted that that is the right way forward.

Are you defending the fact that, although there is guidance from 10 and 20 years ago, we still have no properly functioning hospitality register? Surely that would be a very easy thing to implement that would not be very costly.

Yes, but it is part of Government guidance.

The register that I propose is about continuing medical education. The payments to doctors as key opinion leaders can amount to considerable amounts of money, as is also the case for training, lectures and sponsored symposia. I understand that the GMC takes the matter very seriously and is considering implementing registering on a regular basis. I am not a financial expert, but I do not see a register as being a difficult thing to produce. I understand that the range of guidelines needs to be clear about what has to be declared and what does not, but the implementation of a register would not be difficult.

I think that GPs are employed by the NHS, but as private contractors. I am not an expert on that, though.

We would need to confirm that.