Ineffective Drug or Effective Food? The Social Life of Viartril-S and Regulatory Politics in Taiwan

The regulation of glucosamine products has been more complex and prob­lematic in Taiwan than in the United States or Europe. In Taiwan, Viartril-S is regulated as a drug but has finally become a conceptual food-drug hybrid.

Effective Health Foods, Ineffective Drugs 211 According to the latest edition of the drug permit license for Viartril-S,^[761] this product was approved as a prescription drug in its current form and dosage in 1999. During that time, however, Viartril-S was not as widely used as it is now. A 2006 report in Business Today stated that Viartril-S was initially not considered an effective drug and had relatively low revenue.^[762] This changed when its coverage by the National Health Insurance Administration (NHIA) was approved. The distributor of Viartril-S, Great Union Company, promoted the drug to physicians by emphasizing the scientific evidence for its effective­ness. The company provided physicians and their families with free samples of Viartril-S, a marketing strategy that proved successful—Viartril-S became a bestseller.

Owing to the success of Viartril-S in the drug market, its Chinese brand name, Wei-Gu-Li, became adopted as a general term referring to all glucosa­mine-containing products in Taiwan, regardless of whether they were catego­rized as foods or drugs. The Chinese name is suitable for the marketing of this product because its meaning is “maintain your bones well.” The distributor retained the brand name after it had acquired a general meaning. Thus, the distinction between Viartril-S and other products was further obscured, as was the boundary between foods and drugs. The public confusion on what Wei- Gu-Li exactly refers to led to safety and regulatory issues.

A modification of medical reimbursement policy worsened the situation.

Because of the wide market availability of Viartril-S, arguments about its safety and effectiveness drew attention from an increasing number of people as well as from the TFDA. Some patients considered terminating their prescrip­tions because of the increased cost and doubts about effectiveness.^[764] Neverthe­less, many people were willing to pay for the drug for themselves or for older family members out of filial duty.^[765] Although the drug’s effectiveness was up for debate, most medical professionals respected patients’ choices because of its established safety. However, messages from medical professionals were confus­ing. Several well-known physicians indicated that they did not oppose long­term or high-dosage use.^[766] However, they also mentioned the risk of allergy, and several reported instances of adverse reactions, although such reactions had not been definitively linked to glucosamine.^[767]

In view of the potential harm resulting from this confusion, the TFDA announced a new regulatory framework for glucosamine products in Novem­ber 2002.

The food-drug boundary became further blurred in Taiwan when the effectiveness of glucosamine sulfate was challenged in the scientific literature. In consideration of its well-documented safety and food status in the United States and Japan, the Department of Health^[769] published draft regulations to downgrade glucosamine sulfate from a “prescription drug” to an “instruction

Effective Health Foods, Ineffective Drugs 213 drug” in February 2004.^[770] According to a news report, the authorities even considered classifying it as a food under the condition that the distributor agree to advertise the product without its health claims.^[771] However, the potential market after reclassification did not appeal to the company. The representative of Rottapharm in Taiwan expressed their resistance to classifying Viartril-S as a food or instruction drug. My translation of a newspaper report published at the end of 2004 is as follows:

Great Union Company, the distributor of Wei-Gu-Li, indicated that they would provide the Department of Health with proof from clinical tri­als to allow the product to remain in the category of prescription drug. The General Manager, Yen-Chang Wang, stated that Wei-Gu-Li, with the English brand name “Viartril-S,” refers to the patent owned by its Italian manufacturer, rather than serving a general term for glucosamine sulfate.

By emphasizing the effectiveness of Viartril-S with reference to a study pub­lished in a well-known medical journal, the distributor attempted to clarify the difference between Viartril-S and other generic drugs or glucosamine products, insisting that Viartril-S should remain classified as a prescription drug. How­ever, this did not change the policy. The change was formally implemented in January 2005,^[772] after which glucosamine products with food and drug clas­sifications were both available on the market but with different distribution protocols. Specifically, glucosamine food products could be sold everywhere, whereas glucosamine drugs were only available in pharmacies. However, this difference in product flows was so negligible that even media reports could be ambiguous and misleading. A news report confused the categories of instruc­tion drugs and Health Food and claimed that “Viartril-S” was going to be reclassified as Health Food.^[773] Relevant authorities also released conflicting mes­sages: Although instruction drugs are generally not covered by the NHI pro­gram, they stated that glucosamine sulfate products, including Viartril-S and

more than 30 generic drugs, would be covered. However, the reimbursement criteria were still criticized by some for being too “strict.”^[774] All of these mes­sages complicated the public perception of glucosamine and made it difficult for both laypeople and healthcare professionals to clearly understand glucosa­mine products.

Although glucosamine HCL was widely recognized as a Health Food because of its close relationship with glucosamine-containing drugs, it was regulated as an ordinary food. Manufacturers of glucosamine food products cannot apply for them to be marketed as Health Foods because the symptoms they purport to relieve are not included in Track 1 criteria. No new categories of health­care claims have been added to the criteria in 12 years.

After encouraging the blurred distinction between Viartril-S and other glu­cosamine products, Great Union Company attempted to clarify the difference after entering the market of self-paid drugs. The story of Viartril-S in Taiwan is not only a marketing success story but also an example of an object situated in the borderland between categories established through interactions among knowledge production, categorical shifts, and regulatory contexts. For more than a decade, the distribution of glucosamine followed two divergent paths. First, patients with knee joint osteoarthritis could be prescribed glucosamine sulfate, either self-paid or reimbursed by the NHI, by physicians in hospitals or clinics. Second, both the dietary supplement glucosamine HCL and the instruction drug glucosamine sulfate were widely available in supermarkets and pharmacies. Therefore, although consumers were free to purchase whichever product they preferred without restriction, knowledge and discourses on glu­cosamine products were mixed. The distribution of glucosamine in Taiwan thus demonstrates the social life of a food-drug hybrid.

Although Great Union Company successfully introduced its product into the market of self-paid drugs and generated large profits, Viartril-S was recat­egorized as self-paid much later than expected. After its reclassification as an instruction drug in 2005, news reports stated that the NHI program would soon stop covering glucosamine sulfate prescriptions. However, in response to negative responses from the public and politicians, the NHIA continued to delay the date on which coverage would be withdrawn. In a news report in 2014, an unnamed physician wondered, “Does the NHIA dare to [not cover

Effective Health Foods, Ineffective Drugs 215 glucosamine sulfate]?”^[776] The report also estimated that the number of patients prescribed glucosamine sulfate was approximately 0.7 million and noted that only 10% of Great Union Company’s revenue came from the NHI market. From 2010 to 2020, the NHIA has determined the coverage but not the clas­sification of Viartril-S. Although Viartril-S has remained classified as a drug, its wide distribution is more comparable to that of a Health Food. In 2018, 13 years after its reclassification, Viartril-S was officially removed from NHI coverage.

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