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

Noni juice and the vulnerability of the Filipino to anything 'herbal'

by Gideon Lasco, MD

In the 1990s, juice from the noni fruit (Morinda citrifolia), popularly known as "Noni juice" became a very popular product with its promise as a panacea or 'cure-all', with purported benefits ranging from cancer cure to increased vitality. Until now, this product lingers in some drugstores and is still being marketed in the Internet as a wonder supplement. However, this fad has been replaced by subsequent others - such as mangosteen and mahogany seeds.

The trend we observe is that first, a product emerges in public consciousness by word-of-mouth and heavy marketing. When this word-of-mouth streams to the level of households, a lot of people, particularly women and those in the older age groups would patronize it. Only after several months or years in which the promised claims have not materialized will people discontinue buying these products. By then, the unwitting family would have lost thousands which could have been used for proven "wellness" therapies such as vaccines. By then, the company that sold the product would have made enough profit to move on to promote the next herbal superstar.

In the case of noni juice, a close examination of its nutritional content reveals that the micronutrient (i.e. vitamin and mineral) content of a noni fruit is just similar to that of a raw orange. All its claims were not substantiated by numerous experiments and trials.

Here an interesting observation is seen: while scientific inquiry puts more emphasis on evidence derived from experimentation and tends to ignore anecdotal evidence, the public is actually more likely to listen to anecdotes of healing. For them it is more tangible and more believable that Neighbor Juan dela Cruz had a tumor that disappeared after he drank noni juice compared to a randomized-control trial of several hundred participants drinking noni juice that found no evidence of its efficacy against cancer. Only "personal experience" is weighed heavier than "anecdotal evidence" by the people, hence, only after months of experience of benefit (or lack) will they decide to continue or discontinue a product. This hierarchy of evidence means that Western medicine still has a lot of steps to take in winning the trust of the public. 

Paradoxically, any highfalutin or scientific-sounding name such as "L-Carnitine" also gets high marks from the public. But this is the topic of another essay.

The vulnerability of Filipinos to anything 'herbal' may be traced to our folk medicine heritage. Long before Western medicine arrived in our shores by way of Spain and America, our ancestors sought ways to cure our illnesses and ailments. As in many other cultures, they looked to the plants and trees in our forests. Some proved to be effective and have since been validated by scientific experiments. Regardless of scientific evidence, however, we value these homegrown efforts to cure our ailments. We have a deep cultural, emotional attachment to these therapies, perhaps reminding us of lola brewing oregano or lagundi leaves as treatment for cough.

It is not just our cultural heritage that makes us sympathetic to herbal products. The modernist ideal of going back to nature, which has its roots in New Age philosophy and a heightened attention to health and the body, has also lent its support to herbal products, vis-a-vis the 'artificial' pharmaceuticals. 

Businesses, particularly ' nutriceutical' companies, can abuse this emotional attachment to herbals by invoking them heavily in their marketing campaigns and sensationalizing the range and potency of their therapeutic effects. The disclaimer "No approved therapeutic claims" cannot compete against images of healing that advertisements portray. This is what we see now. There is need for legislation to curb this, as well as public information campaigns to counteract the unopposed one-sided information in favor of these herbal products. 

The rationale for legislation, as well as public information campaigns, is this: there potential harm in using in 'herbal medicines'. Being pharmacologically active substances, just like any other drug they can lead to overdose, toxicity and poisoning, as well as allergic reactions. Since a doctor usually asks a victim of overdose if he or she has ingested any drug and people don't classify these herbals as such, these cases usually go undocumented or undiagnosed. It must be conceded however that these are rare cases and most herbal medicines do not cause substantial harm to the one taking them.

A bigger danger, however, is if herbal medicines take away the opportunity for a patient to avail of medical treatment and the money to finance therapy that is warranted. For example, doctors see many cases of people consulting for cancer that has already reached Stage IV (the cancer has spread to other parts of the body). When asked why it took a long time for them to seek consult, it is not unusual for patients to say that they decided to first try out a particular herbal supplement. But when the tumor continued to grow, that was the time when they decided to finally consult. Here's the rub: Stage I or II cancer if detected and treated early usually has good prognosis, with a growing number of cancer survivors even living healthy lives and normal lifespans. Stage IV cancer usually kills within several months or few years.

On the positive other hand, emotional attachment to herbals can be used in a healthy way. It could win public sympathy for the research and development (R&D) efforts to identify, develop, and market herbal medicines and that work. This thrust has the potential to reduce our dependence on the mainstream pharmaceutical industry. Cough syrups, many of which are themselves not backed by scientific evidence, are better replaced with a nice brew of lagundi leaves. The Department of Health in 2003 and 2007 launched campaigns for the "Sampung Halamang Gamot" but this is largely under-utilized. 

That we have a wealth of ethnopharmacology is clear. In 1949, soil from Iloilo was isolated to have metabolic products that served as the precursor of Erythromycin, a very important antibiotic and Filipino scientists continue to research on the potential benefits of various plants. The late National Scientist Dr. Conrado Dayrit pioneered research on Virgin Coconut Oil and studies are beginning to show its benefits in various ways. It is already routine practice in the Philippine General Hospital to include VCO in the nutritional upbuilding of admitted children in the Pediatrics wards.

The legacy of our herbal healers has definitely persisted to the present time. It remains to be seen if it will ultimately be for the profit of some, or for the benefit of all.