Select Committee on Health Minutes of Evidence

Memorandum submitted by Jenny Hope Medical Correspondent Daily Mail (PI 111)

  In response to a request for written evidence to the above inquiry, I submit the following observations. They are my personal views, based on my experience as a medical journalist, and do not represent the policy of the Daily Mail.

  From a journalist's point of view it seems useful to consider whether the influence exerted by the pharma industry is overt, or covert, and how this affects news reporting. The business of drug companies can do tremendous public good, drugs save lives and improve the quality of lives, but they are extremely powerful corporations which exist to make profit and recoup research costs. The resulting conflict—making profit out of illness—does not sit easily in the British context of free health provision. Nevertheless, drug promotion is a necessary part of the contract. This takes an all-pervasive form, ranging from sponsorship of medical conferences to the use of PR companies to engage the lay media in telling the public about their products. But it's an overt influence that becomes part of the background noise of news reporting. Anyone with knowledge of the healthcare industry, of medicine and of the scientific community knows that many vested interests reside among drug companies, device manufacturers, private providers and insurers, researchers, universities and government health spokespeople. Journalists are always looking for vested interests and maintaining an awareness of hidden agenda.

  For example, we may assume when a senior doctor stands up on a platform at a drug launch there is a strong likelihood he/she may have been paid a fee to be there. This will be taken into account by journalists but won't necessarily undermine its news value, negate or distort the coverage of the story. The enormous halls of drug stands at international conferences quite clearly signal the underlying promotional funding for a global industry. Part of the business of these conferences is "selling" stories to newspapers and broadcasters. The conduit is the PR industry. PR companies organise the press conferences, arrange the speakers and provide background material. There is a clear agenda which experienced specialist reporters take into account. The same considerations apply when press releases and company information come into the offices of newspapers and broadcasting organisations. We expect research data to be sourced and referenced, and the format to follow the codes of practice devised by both industries in the pursuit of ethical behaviour. But reporters apply the same journalistic criteria to the information that we would in covering any aspect of news, whether crime, transport, education etc. However, staff reporters working for national news organisations are not the only target for promotional activity. When a story is in the public domain—or being placed with the specific intention of generating publicity—someone will write about it. If it's me than I know where the information is coming from, the background, and carried out the interviews—there is some quality control. When copy arrives from an agency or individual freelance reporter it's unlikely to be exclusively supplied. They make a living by supplying stories, often to as many outlets as possible. This also raises the index of awareness about the information provided.

  Perhaps the most important issue in assessing influence of the pharmaceutical industry on the NHS is whether it corrupts the data used for an increasingly evidence-based service. Doctors are no longer the prescribing "free agents" they were 10 or 15 years ago. They are subject to NICE guidelines, practice and hospital formularies, prescribing advisers from primary care trusts which are putting increasing restrictions on the decisions they make. The King's Fund, for example, in a recent report On being A Doctor discussed growing constraints on the clinical freedom of doctors, partly because of the tarnished reputation of the profession in recent years. As a result, one could argue the focus of attention must shift to the clinical trial and research data used to gain approval of new drugs, not least a marketing licence, and the post-marketing surveillance. Most medical research is funded by drug company money. It is impossible for journalists to assess whether data published in clinical journals or presented at conferences—whatever the source—is corrupt. This can happen in different ways; data omitted, misrepresentation of findings, the skewed nature of the original protocol. On another level, negative or inconclusive results rarely get published and there appears to be no obligation to publish damaging results from trials, even when NHS patients have taken part. A report in The Lancet earlier this year found negative results from trials on antidepressants in children had never been made public. Researchers obtained information about unpublished trials from confidential data held by the Committee on Safety of Medicines when they were compiling NHS prescribing guidelines for doctors. Every request for unpublished data from the pharmaceutical companies involved met with a refusal.

  As you know the Royal Society convened a working group to look at how research reaches the lay media partly because, in the words of the chairman Patrick Bateson, the results of scientific research have profound effects on public opinion and policy. Journalists have to rely on ethical committee procedures and peer review underpinning publication in medical journals but even their editors express disquiet about the process. Richard Horton, editor of The Lancet, says in an article published in the New York Review of Books (2004 March 11:7-9) that "Journals have devolved into information-laundering operations for the pharmaceutical industry." There is some concern about the whole process of peer review used in journals; the potential for bias, the old pals' act and plain wrongness of interpretation of results. Who does it, what's their conflict of interest? It may not be obviously pecuniary, it could be a personality clash that's behind it. It's a vital part of how specialist journalists assess the credibility of a story but it's a system creaking under the strain of a myriad of vested interests. Ten years ago Professor Peter Sleight, a leading cardiologist involved in major heart disease trials, coined a memorable description. "Peer review is 50% garbage, 50% malice and 10% good advice" he told a Royal Society of Medicine meeting. "What can you expect if a reviewer works in the same field and is almost certainly a rival? Many actually steal data and hold up publication while they publish it as their own research." Just a year later I investigated a research fraud involving a faked trial in the British Journal of Obstetrics and Gynaecology that led to a consultant gynaecologist being struck off for life, the resignation of the journal editor as president of the Royal College, and a shake-up of the editorial board. However, I did not uncover the fraud by unpicking the published research results—I discovered a hospital inquiry was taking place in secret that led to the unravelling of the scandal.

  There has been an outcry over the secretive workings of Government regulatory systems here and in the US. The basic premise of the criticisms is that the MHRA and its advisory committees appear to be in the pocket of the drug industry. As a result, it is claimed, members and experts are too close to the drug firms, which in many cases are their ex-employers, investigations into safety are cursory and drug companies are allowed to choose whichever data makes their product look safe. The scandals involving SSRI products and Vioxx are topical examples. Since 1989 the cost of licensing medicines has been covered almost entirely by fees charged to the drug firms which may have fuelled public suspicion. The shake-up of the CSM appears to be designed to address some of these concerns, disallowing interests in the pharmaceutical industry for example, which could be in place next year. But the key point remains that documentation used by the MHRA to approve licensing request is not available to the press. There is no way of checking the documentation at present. The effect of opening up the Freedom of Information Act in January is not yet known. All data should be available for patients/ journalists/ doctors/ interested parties. It is a moot point whether summaries of clinical trials in an online database will be sufficient. The devil is in the detail. The commercial confidentiality caveat has to be overcome. In the current climate, drug companies cannot be allowed to continue to argue against openess on the basis of protecting themselves commercially. All completed trials should be available for independent scrutiny, whether they study licensed or unlicensed uses. However, Europe-wide regulatory processes are taking precedence over national systems in an increasingly global pharma economy. It is unclear whether they will be in step with any changes recommended or demanded in the UK.

  How do the Press or public know when things are going wrong? The most obvious signals are drug withdrawals, Government safety warnings and research findings which give journalists the opportunity to raise the alarm and investigate. There is a contribution made to all of these processes by the yellow card system for adverse reporting. Yet it's well recognised that relatively few prescribers report adverse reactions and low levels of reporting foster the assumption that little is wrong. I took part in consultation carried out by the former deputy CMO Jeremy Metters to explore different alternatives. The conclusion arrived at by journalists (including the Guardian and BBC) is that unexpurgated information from patients has to be accommodated and available for external analysis. Patient reporting is no longer a privilege to be granted to the public but a right. But post-marketing surveillance has to be a more active process than waiting for damage sustained by patients to be reported by them or their doctors. Patterns of problems might emerge more quickly with a more intensive exercise. What surveilliance is taking place of any planned surveillance of drugs or devices- are these proposals submitted along with applications for drug approvals? In France a new policy dealing with drugs likely to be used on a large scale was brought in last year. It requires pharmaceutical companies to organise a post-marketing study of the public health impact of a drug, which includes close follow up. According to a letter in the British Medical Journal (BMJ 2004;329:1342) this policy has already resulted in an independent large-scale study of 40,000 patients treated with new or traditional anti-inflammatory drugs. More than 50 such studies have now been agreed, which include in some circumstances a stepwise introduction of a new drug. There may be overlap with NICE assessments but the post-marketing elements may bear closer examination.

  The same concerns apply to moves to reclassify medicines from prescription to pharmacy only, which have Government approval (following DoH working party). The system is equally opaque. In the case of the first statin drug to be moved objections were registered by the Consumer's Association and the Royal College of General Practitioners on safety grounds. Individual doctors also expressed concerns. These were published by my paper as part of a story about the switch. However, there is no automatic access to any submissions on such applications other than those released direct to the Press and no access to documentation detailing the reasons for the decision and opposition. The switch was approved without any proper explanation—despite rejection for a similar request made to the FDA two years ago—and the UK became the first developed country in the world to take this step. Subsequently there has been an explosion of advertising both of cholesterol testing and the drug.

  The pharma industry has taken an interest in patient information and patient groups which has resulted in some drug company funding of their activity. However, this should be considered in the context of patients gaining their information on prescription drugs from a product leaflet in which the format and content are strictly controlled by legislation and usually incomprehensible or frightening to the patient. Accusations of disease-mongering are not entirely disinterested. They reveal tensions between prescribing doctors and public health specialists who want population-wide strategies to make a difference, and part of that is managing medical risk factors ranging from osteoporosis to high blood pressure. Guidelines are increasingly being set by professional bodies which define the limits of potential intervention. Raised blood pressure is a serious health threat, I might expect an affected individual to think about it seven times a day—at least until it's under control. Many people, once they have been told they are at risk, or have been diagnosed with a medical condition, crave more information. They get it from a variety of sources, friends, newspapers, patient groups, the Internet—there are more than 20,000 health-related Internet sites. Surveys consistently show that newly diagnosed patients are disappointed with the level of information available to them about their condition. MORI research shows the most preferred method of communication of patient information is leaflets from the GP surgery. A recent study found the UK performed worse than other major Commonwealth countries and the US on patients having information about medicines including side effects. If we accept there is a consensus that people need more information to make choices about their health—even if they are the wrong choices—then disease awareness campaigns can play a useful role. There are an estimated one million undiagnosed diabetics in Britain, and this is a condition which can cause organ damage and premature death. We know companies manufacturing drugs in this area have a commercial interest in promoting awareness, but there is also a public interest that results in energetic activity on the part of patient groups. Donations are made to patient groups by drug companies but in my experience charities tend to ringfence this money for "educational" projects such as leaflets where the funding source is clearly stated, specific drugs not mentioned and an arms-length policy adopted. Harry Cayton, when he was executive director of the Alzheimer's Society, said it was a caricature to say that patient groups were "fluffy bunnies" at the mercy of the "ravening wolves" of the drug industry. The Society had strict guidelines for its relationship and acceptance of donations, and he acknowledged the need for patient groups to have a good relationship with the industry not least to fill the information gap left by the NHS. Any restrictions or banning of such a relationship which involved the removal of pharma funding would surely have to be replaced by state-funded grants.

  One further point about the influence of the industry. Quite apart from the growing significance of PFI in capital investment, we're looking at an NHS where there will be greater involvement of the public sector in the near future. An estimated 15% of elective surgery on NHS patients will be carried out privately but with NHS funding by 2008—so the profit motive will be more in evidence. It's not just in acute care that the scene is shifting. US-managed care of chronic conditions has already arrived in pilot form, and there is another NHS pilot scheme being run in a north London PCT which is managed by a wholly owned subsidiary of a major drug company and provides "care management tools". The PCT states that it does not endorse the use of the company's drugs or encourage any additional access by drug company reps. The NHS Improvement Plan itself actually makes reference to working with pharmaceutical companies. It states that "pharmaceutical industry involvement in the development and implementation of national service frameworks would benefit both the NHS and industry." It also calls for "faster and more effective recruitment of patients into clinical trials via the NHS enabling new medicines to be brought on stream more quickly". We probably need to see a more transparent account of the pros and cons of private involvement in the NHS where profits are being made in the provision of healthcare, and more independent analysis. Whether it's PFI, acute care or chronic disease management. It's not just in the regulatory processes that we need more scrutiny, much though these are in need of reform.

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