Obstacles, Opportunities, Outcomes A Consumer Perspective: Prof. M. L. Tan An overseas Chinese businessman living in the Philippines recently asked me about a “wonder drug” he had purchased on one of his business trips to China, giving it rave reviews about how “excellent” it was for colds and the flu. He had seen it advertised on a Chinese television station, beamed by satellite and received in the Philippines through cable. It turned out that this wonder drug was not herbal, not one of those mysterious inscrutable products of ancient Chinese medicine. It was the antibiotic roxithromycin. That incident stands in sharp contrast to another one involving Alvin, a young Filipino- American friend who had just graduated from an American university and currently in the Philippines for a year of research. Alvin had come down with a respiratory infection in Manila and was prescribed, among other medicines, Dimetapp, for the congestion. On his own, he decided not to buy the Dimetapp because he had just read a newspaper article about a Yale study finding increased risks of hemorrhagic stroke from using the product. I start with these two anecdotes to highlight the rapidly changing settings in which drug information and drug use are taking place, including the problems created. If we are to use that now over-cited cliché from China (and, actually, Japan) the term for crisis – read wei xi in Chinese and kiki in Japanese -- is a combination of two characters, one for danger and the other for opportunity. The situation we have today, one of rising expectations amid an information explosion, creates both problems and opportunities to which we all – industry, government regulatory bodies, and consumer/patient groups – need to respond. We tend to think mainly in terms of the information revolution as the driving force for new economies and markets but we forget this information revolution is itself a function of other important economic and social developments. Let me explain in greater detail, speaking from a consumer perpsective, four vital developments that present both problems as well as opportunities. 1) Rising incomes 2) Rising literacy rates 3) Increased population mobility 4) Information explosion (including the Internet and cable/satellite television) Rising incomes The single most important development affecting the drug environment, especially for the Asia-Pacific region, is that of rising incomes. Although there is still much of income inequity that accompanies this growth, incomes have generally risen, creating new middle classes in many countries, together with rising expectations and demands. These rising expectations are not always realistic, and are easily exploited. I find it unacceptable that families will spend the still small disposable incomes they have on nonsense drugs. A few years back I found families earning about P6000 (US$200 at that time) a month that were spending half of that amount for “herbal packs” with cure-all claims. And in situations where the economic bubble is always ready to burst, as it happens in Asia, there is something unsettling seeing drugs being peddled as a form of insurance. One drug company in the Philippines advertises: "In times like these”, referring to the economic crisis, “it is forbidden to become ill.” and then touts its rather expensive vitamin as a way of preventing illness. Rising literacy In most countries of the region, the literate now form the majority of the population. In some countries, such as the Philippines, literacy rates now exceed 90%, the illiterate now composed mainly of older people. I should hasten to point out, however, that in many countries where gender inequity remains serious, the ranks of the illiterate also include many young women, and this is crucial because women play such a gatekeeper role in health maintenance and care for the sick. This new literate population is the target for mass media, advertising and the new information technologies, all of which are important venues for information (and misinformation) about medicines. On one hand, this can be mean a population that is more – pardon another cliché – “empowered” in terms of using medicines. Many bookstores in the region now stock numerous books on the use of medicines, with vayring quality and reliability. And I at how one can download formularies and drug information and keep them on a personal data organizer or how the entire Merck Manual can fit into one compact disc The demand for information on medicines is strong. Many bookstores in the regions now stock numerous books on the use of medicines, with varying quality and reliability. At the same time, we have to recognize these figures apply only to basic literacy. I would even wonder about how functional this is for many Asians. When it comes to the use of medicines, we need much more than functional literacy for the safe and effective use of medicines. We speak here of a level of understanding of science and medicine needed to understand how the body works and responds to medicines, especially with the many new medicines that have appeared. But this is a minimum requirement. Health care providers and, I would even venture, lay people, need to understand too the meanings of clinical trials for a more balanced understanding of both benefits and risks. My Filipino- American friend, Alvin, for example, only remembered reading about the risk of stroke and Dimetapp but was not aware this applied specifically to young women (young here defined as up to the age of 49), or that it was actually a study on one of Dimetapp’s ingredients, phenylpropanolamine (PPA), which is found in about a hundred other over- the-counter cough and cold preparations in the Philippines. Increased population mobility Although humans have always been an adventurous lot, the mobility of populations in today’s world is unprecedented. Even for countries like the Philippines and Indonesia, archipelagos with islands sprawled out over a huge area, and isolated from mainland southeast Asia, large numbers of people move within and across countries. An estimated 6.5 million Filipinos, out of a total population of 75 million, are working overseas. Where the mobility involves cross-country movements, this means shifting drug environments, all sorts of medicines and drugs moving across porous borders. I have found, for example, Filipino women still using medicines they had obtained in Singapore because of illness when they were working there. In the southern Philippines, we have found deep-sea fisherfolk injecting themselves with Sosegon, an analgesic that was withdrawn from the Philippines many years ago. Finally, in Manila’s many shopping centers, you find stores selling American medicines – all unregistered – together with imported canned goods. Information explosion We come now to the information explosion itself. We think of this explosion mainly in terms of the Internet and indeed this is a significant medium. But the Internet’s reach remains limited in the region. The information explosion is felt much more through cable and satellite television, as well as through the printed media. In countries like China, Thailand, Indonesia and the Philippines, there has been a proliferation of lifestyle magazines, many targeting women because of their gatekeeper role in household spending, often with many articles on medicines. Newspapers, on the other hand, are used more widely now as channels for advertorials. Both Viagra and Xenical were launched in the Philippines after weeks of a well- orchestrated media campaign consisting of articles to prep up demand. In the case of Xenical, these included articles referring to the growing problem of obesity in the Philippines, including mention of surveys cited among children. I would also emphasize that the new media, including the Internet, often work by amplifying older traditional networks, i.e., those with access to rapid information in turn feed this through the traditional “grapevine”. I find there is a shorter gap now between the appearance of new lifestyle drugs and the street pharmacopoeia. Barely a month after Xenical was launched in the Philippines, I was getting questions about the medicines from blue-collar office workers. Implications How do we respond to all these developments? If we were to look at measures that have been taken, in terms of legislation and regulations, we will find that the targets are usually at the level of manufacturing, prescribing or dispensing. On the surface, all these regulations should benefit consumers but in reality, there are often serious gaps that reduce, or even cancel out benefits. For example, the Philippines’ Generics Act is one of the most comprehensive laws of its kind, even hailed as a model for social reform. Among its provisions are the use of generic names for all labels, advertising (of over the counter drugs) and prescribing. All these provisions have great potential for empowering patients. For example, the patient should in principle be able to choose from among different brand names. In principle, too, the patient could learn more about the drug he or she is using, typing in the generic name into an Internet search or able to ask a pharmacist in another country for their medication, which is, more often than not, sold under brand names different from those at home. In the real world it isn’t that simple of course. Awareness of generic names remains low in the Philippines, more than 10 years after the Generics Act, and patients are unwilling to purchase a brand name other than the one “suggested” by the physician’s prescription. Let me give another example of the gaps, this time from Britain. Following increased reports of paracetamol overdosing, health authorities in that country placed a limit on the number of paracetamol tablets that could be dispensed. Has this been effective in reducing overdosing? It may be too early to say but there was a recent report noting that while the smaller number of dispensed tablets may have reduced accidental overdosing, it has not had any effect on those using paracetamol for suicide attempts. The US response to paracetamol overdosing has been different. There, they opted to use additional warnings on labels, including the dangers of paracetamol use with alcohol. It is important to have information on such initiatives, and the impact of these interventions. Clearly, each country will have to develop its own strategies for dealing with information needs. My point is that existing measures should be studied and explored to improve outcomes, especially at the consumer level. Product information inserts, for example, need to be reviewed to make them more readable. Government could tap into mass media for announcements and advisories about medicines. As a medical anthropologist, I would point out there is a dearth of research to look into how the drug environment is shaped. I have mentioned rising incomes, rising literacy, increased population mobility and the information explosion as major factors altering the drug environment but I would say, too, that all four are filtered by culture. The “demand” for particular drugs, particularly current lifestyle medicines, is reshaped by culture. Xenical, for example, has no appeal in societies – and there are many -- that look at the voluptuous as a sign of health, so it’s nor surprising that companies had to medicalize obesity, pointing out its dangers, to build up demand. Or, I should cite a much simpler example. An ad for a mobile phone in the Philippines recently showed a family driving around and suddenly deciding to call a relative living in the United States to ask her to send certain gifts back to them. The final request comes from the man: “Don’t forget the vitamins.” This in a country with several hundred brand names of vitamins on the market. Much more research is needed as well to determine how existing policies might be improved, or revised, and to monitor the impact of older regulations. The case of oral contraceptives comes to mind. Is it realistic to keep this a prescription drug when in fact it is already widely sold over the counter, with all kinds of off-label uses? If it becomes an over-the-counter drug, how might package inserts be improved to ensure the pills are used safely and effectively? Given the limitations of package inserts, would phone hotlines be useful for patients? New Stakeholders There are so many players and stakeholders that are not sufficiently drawn into the process of collaboration. There are the dotcoms and internet providers but I’m also thinking of the new roles played by mass media, who continue to be excluded, seen simply as recipients of press releases and advertorials rather than becoming active agents for disseminating information about medicines. (Slide) I’m also thinking of patients’ groups, such as those of people living with HIV/AIDS. For better or for worse, such groups emphasize access to medicines, including the fast- tracking of drug regulatory processes, which I feel could compromise safety and efficacy. But certainly, the patients’ groups need to be tapped as well for the appropriate use of medicines and for tracking down resources. There are opportunities for drug companies to work with the patients’ groups, as they have with cancer support groups. (Slide) Traditional consumer groups will still have to play an important role for other aspects for consumer product information, and the promotion of safe and effective use of medicines. The bottomline is that consumers need to be able to make informed choices, and that these redound to the common good. Increased access to medicines, and information about medicines, is good public health. Indiscriminate use of medicines – underdosing, overdosing, inappropriate off-label uses – contribute to problems such as drug resistance, increased morbidities and mortalities, and ultimately, wasted household and public expenditures. I’d like to end with a slide to show what problems we face. Only a few days ago, as part of research for another paper, I was able to purchase 8 tablets of Cytotec (generic name: misoprostol) from a street vendor. Cytotec itself was withdrawn a few months back by its manufacturer from the Philippine market and substituted with a new formulation combining misorprostol and an NSAID. The Cytotec I bought was being touted as an abortifacient, which is actually its side effect. The vendor who sold it tore out a sheet from a little notebook, giving instructions on how it should be used. It was handwritten. Here we have an example of an “over-the-counter” purchase for self-medication, for a crucial medical procedure. I know it is an extreme example but it serves to dramatize where we are today in many countries. People have their own networks not just for information about medicines but for the medicines themselves, crossing borders, transcending traditional channels of information and regulation. Where, I must ask now, do we fit in all this?