Forgetting that hostage incident
BY DUCKY PAREDES
Finger-pointing on ethics
A.G ROMUALDEZ JR., M.D
‘Despite a drastic reduction in the prices of selected medicines, drugs remain inaccessible to large segments of the population.’
ACCESS to and availability of medicines is one of the major contributors to the inequalities in health status between rich and poor in the Philippines. Until now, the major discussions on this issue have been about prices. It has been noted however that despite a drastic reduction in the prices of selected medicines following the Cheaper Medicines Law, drugs remain inaccessible to large segments of the population. Clearly, there are other factors that influence the availability and accessibility of safe and effective medicines for sick Filipinos.
One of these factors is the continued misuse or overuse of ineffective, inappropriate, and often unsafe preparations for treatment of illnesses or enhancement of health. This irrational use of pharmaceutical products is a result of aggressive, often unethical, marketing and promotions practices of a highly competitive industry in a severely imbalanced market.
Last week, Medicines Transparency Alliance (MeTA) Philippines ran a series of round table discussions on the ethical promotion of pharmaceutical products. MeTA Philippines is a broad alliance of government agencies, health professionals, industry organizations, academics, international agencies, civil society groups, and other stakeholders concerned with the operations of the pharmaceutical sector in the country. The alliance was among the major advocacy groups that participated actively in the lobbying efforts to support the recent Cheaper Medicines Law and the Food and Drug Authority (or New FDA) Law. As well, it has taken part in crafting the implementing rules of these two pieces of legislation.
The round table discussions, facilitated by a consultant from Health Action International (a civil society organization that specializes in pharmaceutical policy studies and advocacy), was designed to elicit perceptions of a wide range of stakeholders in the pharmaceuticals sector about the ethics of marketing and promotions in that sector. Participants were divided into five separate groups and asked to respond to a paper on the present situation of ethics or lack of it in the marketing and promotion of medicines.
The group of academics looked at the current status of ethics education in the curricula of the different health professional education institutions. They perceived a general lack of enthusiasm among both faculty and students for deep thinking about ethical issues. It was observed that the most deficient aspect of ethics education appeared to be that of role-modelling. This was based on the perception that many of the most senior and respected faculty – who were the most likely to be imitated by students – were themselves gross violators of ethical principles in their relations with pharmaceutical industry. Nevertheless, suggestions were made on integrating ethical promotions issues in the various health sciences curricula.
The health professional discussion group consisted of doctors and pharmacists who had the most extensive dealings with pharmaceutical marketing activities. These groups acknowledged that ethical problems existed but essentially laid blame on drug companies. The groups generally advocated for self-regulation in the form of existing or newly revised codes of ethical behavior. It was acknowledged however that mechanisms for monitoring compliance and imposing sanctions on violations were woefuly inadequate.
Industry groups were divided into local or Filipino suppliers and the multinational companies and were met separately. Each group blamed the other for the apparent perpetuation of unethical pressures on the health professions (especially physicians). The local companies generally opposed the imposition of external ethical restrictions preferring individual company ethical guidelines. The multinational group preferred industry-wide self-regulation and pointed to the marketing code of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) as a model that might be adopted by all drug suppliers. As may be expected both groups preferred minimal government regulation of marketing practices.
Some interesting observations were made in the advertising and media group. For one thing, the purported media representatives were actually public relations practitioners rather than journalists or working media people. Thus their views were generally aligned with those of industry. Advertisers claimed that their self-regulatory processes included cooperation with regulators and that their work reflected compliance with regulatory restrictions. It was implied that the regulatory agencies generally approved advertising copy.
The group of drug regulators consisted of the various units of the current Bureau of Food and Drugs (BFAD) as well as other DOH regulators due to be merged with the new FDA. The most common complaint aired within this group was the apparent lack of higher level support within the Department of Health and government in general. Regulators were in general not protected from harassment by a very aggressive industry who were quick to file lawsuits against regulators who called attention to ethical and regulatory transgressions. It was agreed in this group that government would have to formulate more stringent policies on trade in health-related products before there could be stricter enforcement of the "approved therapeutic claims" regulations.
All of the discussions revealed that stakeholders generally agree on the existence of major ethical problems in the marketing and promotions of pharmaceuticals (prescription and over the counter) as well as nutritional supplements. However, they vary on who is to blame for this situation, each group pointing their collective finger at the others. It seems that such reactions are fairly common in our society.
One of the health sector areas that requires close monitoring with respect to claims of effectiveness and safety is that of cosmetology and related activities. A couple of weeks back, this column referred to an unproven and possibly unsafe skin whitening intervention by means of the intravenous injection of a glutathione preparation not yet registered by BFAD.
The other side of skin-whitening is tanning or skin-darkening. Natural tanning by means of exposure to sunshine is the preferred mode of tanning by most light skinned individuals. But in the United States and Europe, indoor or artificial tanning has gained such popularity that the sale of devices and the patronage of facilities offering these services have evolved into a multi-million dollar industry.
Last week’s issue of the New England Journal of Medicine, in its regular feature on "Science, Behavior, and Policy", warned about the dangers of arterial tanning. The article cited data linking the use of artificial tanning devices with cancer of the skin that have led to "tightened...restrictions on indoor tanning; France, Germany, Austria, Finland, and Britain, for instance, ban indoor tanning for people under the age of 18. Some U.S. states have also enacted restrictions on access for minors, but many have not".
Modern diet or weight reduction pills work by appetite reduction through their satiety inducing action on the appetite centers of the brain. In 1997, two such substances (fenfluramine and dexfenfluramine) were withdrawn from the market after serious cardiovascular side-effects such as pulmonary hypertension and heart valve effects were noted. That same year, a new product, sibutramine (brand name "Meridia") was approved by the US FDA. Recently, the same agency has called for a review of the drug’s registration status in response to findings of cardiovascular effects by the "Sibutramine Cardiovascular Outcomes (SCOUT) Trial". As reported in the New England Journal of Medicine, "increases in blood pressure (1 to 3 mm Hg) and heart rate (4 to 5 beats per minute) consistently accompany the use of the drug".
Emaiul: alberto.romualdez@gmail.com)