Bad Medicine
By P.A. Castro

A Google search of Viagra yielded 11,500,000 sites – and narrowing it to “Buy Viagra” still yielded 5,530,000 sites, testament to the prescription drug’s popularity, and, to a certain extent, easy accessibility.
But not all Viagra (sildenafil citrate) tablets sold are real. According to the Florida Statewide Pharmaceutical Services and Drug Wholesaler Advisory Council in the US, of the 32 top counterfeited drugs, sexual potency drugs (Pfizer Inc.’s Viagra and Lilli ICOS’ Cialis) come second only to cholesterol-inducing medication Lipitor (atorvastatin). Even the World Health Organization (WHO) admits that Viagra is “one of the most counterfeited drugs today.”
This may be largely because, since it was first distributed in 1998 as the first medicine developed for erectile dysfunction, over 170 million prescriptions have already been prescribed by 600,000 doctors. Roughly, this means that about nine Viagra tablets are sold every second somewhere in the world, making the medicine one of the most popular drugs ever.
Already, aside from selling fake Viagra tablets, there are alternatives – referred to as herbal Viagra – proliferating the Internet, claiming to be able to duplicate the effects of Viagra. A Google search of “Herbal Viagra” yielded 1,870,000 results, again demonstrating its ready availability.
In a report titled Combating Counterfeit Medicine, the WHO stated that the production, distribution, and sales of counterfeit medicines, which have been dramatically rising in recent years, matter because its implications are wide, and often connected. Counterfeit medicines obviously have health implications by disregarding patient safety, and increasing morbidity and mortality rates. These, subsequently, have economic implications because of the wastes of already limited government resources for health. Also, adds the WHO, these easily jeopardize the development of the medicine industry.
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10 DRUGS MOST SUSCEPTIBLE TO FAKING IN THE PHILIPPINES
1. Antihypertensive drugs (Adalat Gits 30mg Tablet)
2. Anti-asthma (Ventolin Expectorant syrup)
3. Analgesic (Ponstan 500)
4. Antidiarrhea (Diatabs Reformulated),
5. Vitamins (Propan with Iron Capsule, Ceelin 100 mg/5 mL Syrup, Enervon C and Iberet 500)
Source: Bureau of Food and Drugs and the Department of Health (February 18, 2005)
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PRO-ACTIVE APPROACH
In order to battle the proliferation of fake medicines in the Philippines, 12 organizations from various industries formed the Coalition Against Fake Medicines (CAFM). Government agencies Department of Health (DOH), Department of Trade and Industry (DTI), and the Department of Justice (DOJ) joined forces with medical groups Philippine Medical Association (PMA), Philippine Pharmaceutical Association (PPHA), Drugstores Association of the Philippines (DSAP), Mercury Drug Corporation, Watson’s Personal Care Stores, Zuellig Pharma Corporation, and Pfizer Inc., as well as major media players Philippine Daily Inquirer, and GMA 7 Broadcast Network to reduce the incidence of fake medicines. While the overall goal is to enforce existing laws against counterfeiting, CAFM also aims to increase awareness of the problem among the consumers with the hope that they, themselves, will be able to correctly determine the authenticity of the medicines they are buying, and will thus not be victimized by counterfeiters.
In a statement, the coalition stated: “(While) medicines play a critical role in curing and controlling diseases and consequently in improving lives, it is very important to differentiate real from fake medicines. The medicine you are buying from unscrupulous vendors may not only aggravate your health, but it can also lead to your untimely death.”
The data on the proliferation of fake medicines is staggering. The WHO believes counterfeits make up between 5% and 8% of the $550 billion worth of medicines annually sold worldwide. 60% of counterfeit medicine cases actually occur in least developed and developing countries, with anti-malarials, antibiotics, and HIV and AIDS drugs among those targeted by suppliers. Overall, this industry is worth over $35 billion.
Also according to the WHO, 60% of fake medicine cases occur in developing countries, and the other 40% in developed countries. In the case of the former, as much as 25% of medicines consumed are counterfeit or substandard. In the Philippines, WHO data shows that at least 8% of the drugs bought in 1995 were fake (See Table 2).
Table 2: PROLIFERATION OF FAKE MEDICINES IN SE ASIA
| COUNTRY/YEAR OF STUDY |
FAKE MEDS IN MARKET (%)
|
Myanmar (1999) |
4% |
Laos (1990-1993) |
17% |
Cambodia (2001) |
10% |
Vietnam (1999) |
4% |
Philippines (1995) |
8% |
Malaysia (1997) |
5% |
Source: Combating Counterfeit Medicine, World Health Organization
Over time, the figures have been increasing. In the US alone, from only four counterfeit drug cases filed by the Food and Drug Administration (FDA) in 1998, the number increased to 22 cases in 2002. In 2003, when national drug-testing laboratories in Phnom Penh and Bangkok examined 230 samples of 24 pharmaceuticals purchased in Cambodia in 2000, about 3.5% contained less than 60% of the quantity of active ingredients in the labels, with some containing the wrong ingredient. At the same time, in Nigeria and Pakistan, counterfeit drugs is said to account from 40% to 50% of the total market.
If the available figures are not scary enough, however, various cases from all over the world show how bad the effects of counterfeit medicines can be. In 1995, for example, an inactive meningitis vaccine containing only water was used to treat up to 80,000 people in Niger. Thousands died from the fake vaccine’s ineffectivity. The same instances have been noted in Mekong countries in 2001, when more than one-third of antimalarial artesunate products in Cambodia, Lao People’s Democratic Republic, Myanmar, Thailand, and Vietnam contained no active ingredients.
Other cases cited by the British Medical Journal included a meningitis vaccine made of tap water, contraceptive pills made of wheat flour, and a Paracetamol syrup made of industrial solvent.
CONSTANT VIGILANCE
Already, various pharmaceutical companies, such as Pfizer Inc. and Lilli ICOS, producers of Viagra and Cialis, respectively, have pursued cases against online suppliers. Both companies have, however, also been developing high technology tracking systems, also called radio frequency identification (RFID), which would serialize every legally produced medicine so that these can be properly monitored.
The CAFM, however, intends to also empower the consumers by educating them. The alliance has created a toll free hotline – 1-800-10-FAKEMED (3253-633) – for any consumer in doubt about the authenticity of bought medicine; and has been circulating materials on counterfeit drugs to branches of Mercury Drug and member drugstores of the DSAP to help consumers distinguish fake medicines from the genuine ones.
According to the group, making a distinction between fake medicines from the real ones is never easy, so that even buying from reputable drugstores is no guarantee, particularly since the producers of fake medicines make their products look as similar as the real ones as possible. There are, however, some obvious identifiers noticeable among fake medicine supplies intercepted by authorities.
Among these identifiers are the differences in the color or texture of the tablet, capsule, or ampoule and/or its content from the ones a regular consumer usually buys, brand names that are bigger than the generic names, and the absence of generic names. It is also suggested for consumers to check the medicine’s BFAD-registration, as well as taking note of the lot/batch number and expiration date of drugs bought, since, generally, only genuine drugs comply with this specification that is also stipulated in the law.
When still in doubt, consumers are advised to discontinue use, and present unused medicines with the receipt to authorities for proper action.
Vigilance, stated CAFM, is the winning strategy against counterfeit medicines.
“Combating counterfeit medicines is a never ending battle,” stated the WHO in its report. And for it to work, “it is not only the responsibility of medicines regulatory authority, (but the) coordinated efforts of multiple partners, including law enforcement agencies, health professionals, consumers, and other relevant stakeholders, is needed.”
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