Saturday, January 3, 2015

Drugs, supplements, and Universal Health Care

by Gideon Lasco, MD

Attaching the word "universal" to "health care" is far more difficult in real life than in paper, for it involves reconciling the oftentimes disparate interests of various stakeholders. This is where regulation comes in: it tries to balance these interests while ensuring quality health care that is safe, equitable, and affordable.

In the ongoing “Secretary's Cup”, a series of talks, debates, and town-hall meetings organized by the Department of Health and its partners, "regulation" is highlighted as one of the six building blocks of Universal Health Care (UHC).

One of the key themes in regulation is the management of health products or medicines. From antibiotics to vitamins, drugs are part of our everyday lives, and we see them as fundamental mediator of health and wellness in our bodies. In this article, we examine areas where regulation is most needed.

Generics and branded drugs
The prices of medicines in the Philippines rank among the highest in Asia. In response to increasing demand for cheaper medicines, the Philippines enacted laws in 1988 and 2008 promoting generics, and parallel importation of branded drugs.

The results have been mixed. Today, generic drugstores are ubiquitous, and government-run Botika ng Barangay outlets cater to many communities. On the other hand, many people continue to distrust generics. A significant number of doctors share the view that inasmuch as they want to support generics, they do not wish to entrust their patients' health on generics that they say are of doubtful efficacy.

This is where regulation comes in. With sufficient credibility, the Food and Drug Administration (FDA) can narrow the perception gap between branded and generic drugs with its pronouncements of safety and efficacy.

Meanwhile, Ponstan, a pain reliever, costs less than two pesos in India and almost 16 pesos in the Philippines. Bactrim, an antibiotic, costs just 56 centavos in India and P18.16 in the Philippines.

Drugs and food supplements
Another important regulatory concern involves “food supplements”. In theory, they are not drugs, freeing them from the stringent requirements for drug approval. But in practice, they are marketed as drugs and treatments for particular conditions, notwithstanding the obligatory disavowal that follows their TV advertisements: “No approved therapeutic claims”.

These supplements fulfill people's needs that are not dealt with or sanctioned by the medical establishment, such as skin whitening and weight loss. Other supplements also promise to treat conditions such as cancer, diabetes, heart disease, whose treatments would be far more expensive if availed of from conventional medicine.

There are serious issues of safety among these products. As 'non-drugs', the ingredients of these drugs have not been examined thoroughly. They may contain harmful ingredients, and at high doses, they might be toxic to the body, unbeknownst to their adherents. For instance, comfrey, an herbal supplement widely promoted in the 1990s, turned out to be potentially harmful to the liver.

Moreover, there is also the issue of opportunity cost: If a patient takes a supplement to treat his or her cancer instead of going for chemotherapy, and in doing so, forfeits the opportunity to avail of life-saving treatment, who is to blame? Ultimately, it is the government's responsibility to ensure that consumers make informed choices. It must examine the way these products are marketed. Therapeutic claims, explicit or implicit, must not be advertised unless validated.

Traditional and modern medicines
Related to supplements, there is a challenge of integrating (and regulating) traditional remedies, particularly herbal medicines. In the early 1990s, the DOH led by Dr. Juan Flavier embarked on a campaign to promote herbal medicines as remedies for common ailments such as cough, culminating in the promotion of the “Sampung Halamang Gamot” (Ten Medicinal Plants). Lagundi, one of the ten, has been well-researched and the University of the Philippines National Institutes of Health has endorsed its efficacy and safety as a cough remedy.

Traditional and modern medicines should be treated equally by regulators. Herbal medicines, despite their being “natural”, must be evaluated for possible side effects and toxicity. But as lagundi has demonstrated, it also has the potential to be at par with other medicines in terms of effectiveness, and thus, they need to be taken seriously. Considering our wealth of plants and healing traditions involving plants, further research is needed to validate their therapeutic (and economic) potential.

Conclusion: Medicine and medicines
In this article, we looked into dynamics of branded and generic drugs, drugs and 'supplements', as well as traditional and modern medicines. In managing these relationships, it is the responsibility of the regulators, such as the FDA, to protect the interest of consumers. Moreover, in the larger framework of health reforms, it is important to recognize that universal access to Medicine should always be accompanied with universal access to medicines that are safe, effective, and affordable.

Manila
September 14, 2012

REFERENCES

Pizaro, O (2011). “Review of the Cheaper Medicines Program of the Philippines”. Philippine Institute for Development Studies. Available at: http://www.dbm.gov.ph/wp-content/OPCCB/fpb/b_DOH-CheaperMedicines/i-Cheaper%20Medicines%20Program%20Review.pdf

Lizada (2007). Food Safety in the Philippines. USAID. Available at: http://www.scribd.com/doc/4938633/Food-Safety-in-the-Philippines-Problems-Issues-and-Opportunities-for-the-Small-Farmers-and-Produ


No comments:

Post a Comment