A Holistic View of Therapeutic Advance

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1 A Holistic View of Therapeutic Advance Per Wold-Olsen President, Europe, Middle East & Africa Merck & Co., Inc. G10 Medicines Workshop on Information and Patients 19 December 2001, Luxembourg This paper was produced for a meeting organized by Health & Consumer Protection DG and represents the views of its author on the subject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumer Protection DG's views. The European Commission does not guarantee the accuracy of the data included in this paper, nor does it accept responsibility for any use made thereof. This is an important and timely discussion. We live in a world in which the pace of change is irresistible. The Internet brings a new world of information to anyone with a computer and a modem. Patients and consumers are increasingly demanding more information about their own health and are eager and willing to take amoreactiveroleinmanagingit.inourfield,thepaceofdrugdiscoveryis accelerating due to the impact of genomics and other new technologies. The status quo is no longer tenable, and we can be grateful to the G10 and to DG SANCO for airing the issues and areas that need change for Europe to realize its vision of an information society that will contribute to the improvement of health for all European citizens. We are in the midst of a therapeutic revolution in medicine, with new medications for a range of chronic conditions providing physicians with the tools to help their patients live longer and to improve their quality of life. Let s take the example of the statins, a new class of medicines introduced roughly 15 years ago to treat high cholesterol. For the first time ever, these medicines - based on scientific advances that led to the 1985 Nobel Prize for Physiology or Medicine to Michael Brown and Joseph Goldstein - offered real treatment options. When the results of the Scandinavian Simvastatin Survival Trial (4S) - a clinical trial in almost 4500

2 patients -- became known, we had compelling evidence of greater than 40% reductions in coronary mortality for those patients that had suffered myocardial infarction and angina. In recent weeks, you will have seen the results from the Oxford study of more than 20,000 patients demonstrating the benefits of broad treatment with simvastatin in people usually seen at lower risk for cardiovascular disease (for example, patients with diabetes). What does this mean? Treatment with statins is proven without a doubt to help people live longer, and they will continue to make productive contributions to society rather than live with disabilities. Even more dramatically, based just on the mortality reduction data from 4S and the number of people treated in Europe today, this year alone an estimated thousand lives were saved by statin treatment. That is impressive. However the number could have been doubled, as unfortunately only half of those who should be treated are being treated. - And this is 15 years after those drugs were introduced. The undertreatment of conditions for which modern medicine has developed effective remedies places a heavy burden on society. (Overtreatment and inappropriate treatment are also problems, but RAND 1 studies show that undertreatment of chronic conditions is a particular concern.) High cholesterol is not the only condition that is undertreated. In the US, Japan, and the five largest European countries, less than half of the 185 million people suffering from hypertension are treated today nearly half a century after the introduction of effective drugs to control high blood pressure now available. While many of the more than 50 million patients living with asthma worldwide are treated with a range of therapies, more than one-third are not compliant with their therapy, and more than 1 RAND a contraction of the term research and development is the first organization to be called a think tank. 2

3 half of those treated report that they still have symptoms and find it hard to sleep through the night. Often this set of issues disparities in access to therapeutic advances and the costs of non-compliance with prescribed therapies is viewed largely in terms of budgetary constraints or other barriers to care and treatment. But it is also due to a lack of dissemination of information appropriately reviewed and balanced about the full range of therapeutic choices to all Europeans. This is just one aspect of the information landscape in European healthcare. The Commission has certainly accepted the need for action to improve the options available to all patients and consumers in Europe. When Commission President Romano Prodi and his Commissioners met with the Council in Lisbon and Feira in March and June 2000, they developed an eeurope action plan, a blueprint for a new European agenda to use e-technology to achieve an Information Society for All. The Member States agreed on the strategic importance of full exploitation of new information technologies in the public administration of health, for the benefit of the citizen as consumer of both health care services and health information. One of the key targets of this plan was Health Online, which had the primary objective of developing an infrastructure of user-friendly, validated, and interoperable systems for health education, disease prevention, and medical care. This commitment to e-health in Europe has been affirmed repeatedly in the intervening months by the Council, the Commission, and the European Parliament. For instance, in April 2001 the Parliament s Report on the Programme of Action in the Field of Public Health noted that the Community should take into account the right of patients to receive simple, clear and scientifically sound information about their illnesses, available treatments and ways of improving their quality of life. More recently, as part of its regulatory review process, the Commission has proposed to amend the Advertising Directive to allow for a pilot with direct-toconsumer communications to ensure the availability of better, clear and reliable 3

4 information on authorised pharmaceuticals for patients with HIV/AIDS, asthma, and diabetes. There is confusion on this topic today. I will volunteer a few comments later, but first let s look at some of the broader dimensions of the question of information for patients. Pharmaceutical companies have an important role to play in providing information to patients at various stages in the life cycle of our products. At the clinical development stage, patients are involved in clinical trials, and provided with detailed information on the potential benefits and risks of the experimental therapy before giving their informed consent to participate in the trial. Around the launch of new medicines, pharmaceutical companies provide a wide range of accurate, balanced, and reliable information on the product characteristics to prescribing physicians and also through the product information leaflet and European public assessment report. And as the new medicine finds its niche in medical practice, pharmaceutical companies provide a range of information to help in meeting public health needs working with other organizations to help raise awareness of the disease, to encourage people to consult their physicians, to improve understanding of the potential benefits and possible side effects of treatment, and to help patients to become more fully involved in the diagnosis and treatment of their conditions. You ve heard already about an interesting BPH (Benign Prostatic Hyperplasia) example from Dr. Coulter. Informed patients are discerning patients: There s a growing body of evidence from cases as varied as BPH, hypertension, breast cancer, and diabetes, for example that patients who take an active role in managing their care have better health outcomes. This stands to reason: the more a patient knows about a disease its causes, its prevention, its alleviation, its remedies, and its associated effects the faster his or her health can be restored. When certain therapies are prescribed, well-informed patients are more likely to use them efficiently. This reinforces the case for better information for patients. Not only 4

5 does it make sense from the patient s perspective, but it also makes sense from the health system perspective. Resources will not be wasted. Outcomes of medication use will be better. Health budgets will benefit. Let me focus on the budget question for a moment. We know that every medical authority is anxious to cut down on its healthcare and its drugs bill, afraid that it will get out of hand. Indeed, one might argue that the real reason behind ministerial resistance to the free flow of medicines information is not a paternalistic concern for patients but instead a fear of creating an insatiable demand for the unaffordable. But no nation s health should be considered in isolation; and no health service s medicine bill should be considered in isolation from its other costs. Against the expense of drugs should be placed the national economic saving on other costs in the system: the costs of hospitalization, of lost working days, of social security benefits and community care, to say nothing of the unquantifiable toll of family strain and physical misery. Equally important is a point I mentioned earlier, that well-informed patients are more likely to adhere to prescribed medications, with safer and more successful outcomes and more efficient use of healthcare resources. Indeed, noncompliant patients are actually the most costly patients to society. Why do I say this? If a patient takes his or her medicine only half the time, it won t work, and the money spent on the drug doesn t lead to the intended benefits. areas, rates of non-compliance average roughly 50%. Across different therapeutic One way to deal with this is to encourage consumers to become more health literate, a point to which I ll return. The debate over the Commission s proposed pilot to amend the advertising directive will continue. However, I would say that better information can actually help patients and consumers to understand health conditions they might not know they or their families have, as well as the availability of suitable treatments to help. The Commission s recent proposal to test the waters in this area is a welcome step toward improved patient communication in HIV/AIDS, diabetes, and asthma (though 5

6 one might ask questions about why just these three disease areas, and whether the pilots apply to print and television ads alike, or just television?). We should be very clear, however, that we are talking about two different issues experiments or initiatives with direct-to-consumer communication and advertising vs. broader access to information of all kinds through the net. Member States know that information on pharmaceuticals will eventually flow, whatever they do, because the legislative framework has been overtaken by rapid advances in technology and by rising public demand for information. Through the Internet, European citizens already have wide access to a variety of sources of health information from third-party suppliers inside and outside the EU. But this access is only available to Internet users. And there is no certainty that the information supplied is accurate, appropriate, comprehensive -- or even comprehensible. To ensure that there is both equity in health information, and that European citizens are empowered to play an active role in managing their health, we need new tools to help people cope with the flow of information. You heard this morning from Brian Ager about the EFPIA Guidelines for company-sponsored Internet sites. These guidelines are entirely consistent with the draft quality criteria for health-related Websites that emerged from the Commission s workshop in Brussels last June, at which Commissioner Liikanen observed the need for tools to assist individuals sifting through the mountains of information available on the Internet, so that he or she may be better able to discern the good, from the bad or merely ugly. The EFPIA guidelines reflect the principle that the best policy will ensure that European consumers receive balanced and accurate information in their own languages based on European summaries of product characteristics when they decide to sit down and seek the information. The Guidelines are also consistent with the Swedish Information Practice Committee guidance that treats the Internet analogously to a library. In this view, the general public is free to search for information about their health that meets their 6

7 needs, when they decide to take action. It s not going too far to say that many see this as their right and indeed it is, under the European Convention of Human Rights. Perhaps the best way to allay the anxiety that many express about the potential risks of liberalized access to health information is to place more attention on improving health literacy. While improving the availability of high-quality, evidencebased information, we could also work on providing patients and consumers with better tools to assess the quality of the information they receive from whatever source and to be able to discriminate between reliable and unreliable information. I d like to close with two observations. The first is that, for better or worse, we re now living in an information society, where the Internet and other communications technologies mean that most Europeans are swimming in a sea of health information. I ve suggested ways that the pharmaceutical industry, health authorities, health professionals, patient groups, and other interested parties can work together to ensure that patients and consumers have the tools they need to navigate this sea of information effectively. Moving forward we have to find ways to make the information society work for patients and for better health outcomes. The pharmaceutical industry together with other stakeholders has an important role to play in achieving this goal both through the Internet and through DTC communication. Finally, a related point about patient empowerment and this morning s discussion of the digital divide. We have seen a shift from our parents generation to ours. My mother listened passively to whatever her physician told her, she had no idea, while my wife and I ask why and want to understand what s being prescribed. Our kids and yours will go even further. We ve already seen a harbinger of this attitude in the activism of AIDS patients and cancer patients in recent years. This generation will say medical decisions are about my life, and I m the best judge of what s most important to me. They are already taking an active role in studying their 7

8 health. Going forward and I do believe that this discussion of G10 is about tomorrow - the new generation will demand access to the information they need to establish a productive dialogue with physicians about their health and about their treatment options and ultimately their therapies. And you know what these are good patients cost-effective patients. This is the challenge we face today in realizing the vision of a European information society of tomorrow that results in improved health for all, and not only the privileged or resourced! Thank you. 8