Monday, March 15, 2010

Cuba in Halal Market

(Old report)

How Cuba is tapping into the growing halal market, and improving public health in the process

The Organization of the Islamic Conference (OIC) is emphasizing a push to make vaccines that conform to religious dietary restrictions in an effort to increase their use and improve public health. Malaysia is spearheading this effort, with one research university already developing a religiously approved vaccine for meningitis B in cooperation with the Finlay Institute, a Cuban biotechnology firm, and GlaxoSmithKline, the giant U.K.- based health care company.

The manufacture and certification of a vaccine that conforms to Islamic law is intended to alleviate suspicion over its safety or religious permissibility, and thereby encourage greater application of the vaccine. As more people are vaccinated against this highly contagious disease, it is hoped that the incidence of meningitis B will decrease, thereby improving public health on a global scale. But what’s in it for Cuba? The market for products approved by Islamic law is estimated at $560 billion- a nice incentive for the economically struggling island to contribute research funds and intellectual property to the endeavor.

During the Hajj and Umrah seasons, times when Muslim pilgrims from around the world pour into the holy city of Mecca in Saudi Arabia, pilgrims bring home more than just souvenirs: they often bring home a host of infectious diseases, as well. After several outbreaks of meningitis and other contagious diseases during the pilgrimage seasons due to overcrowded conditions and close contact with visitors from all over the world, Saudi Arabia has instituted vaccination requirements for all visitors applying for a pilgrimage visa. Although safe and effective vaccines are available, many people are wary of taking them because of what they may contain.

As more people question what is in their medicines, the Cuban biotechnology firm Finlay Institute is joining with the Malaysian research university Universiti Sains Malaysia and British GlaxoSmithKline to make a meningitis B vaccine that would conform to Muslim religious dietary restrictions, thereby opening the door to a multibillion-dollar, virtually untapped market for medicines that are halal, or religiously-approved by Muslim law. Vaccines that are suitable for everyone, however, is not only a good business idea, it is essential to maintaining international health security. Prime Minister Datuk Seri Abdullah Ahmad Badawi of Malaysia emphasizes the need for improved vaccination against diseases that affect children most, lamenting that, according to the 2004 United Nations Population Prospect Report, the Organization of the Islamic Conference (OIC) countries suffer some of the highest mortality rates for children below five years of age[i]. The OIC also includes seven out of 10 nations with the highest infant mortality rates[ii]. Abdullah puts at least part of the blame on under-vaccination, and has recruited Cuban investment and Cuban innovations to address it.

What makes a product halal, permissible under Islamic dietary law, or haram, prohibited by religious restrictions, has to do with the ingredients it contains and how those ingredients were prepared. Any meat product, for example, must come from certain acceptable animals, and be raised and slaughtered in specific, sanctioned ways. To make a vaccine, however, a virus must usually be cultured within animal tissue. Often, this process is accelerated with the aid of glucose, fetal calf serum, or various other substances derived from human or animal substances[iii]. Although vaccines are later purified to remove any non-virus material, because it might have been made using haram ingredients, like parts of an animal that was not killed according to halal rules, the entire vaccine might be considered forbidden by religious law.

Malaysian and Cuban counterparts are uniting to produce a meningitis B vaccine made specifically from extracts of certified halal animals slaughtered according to Islamic tradition. Higher Education Minister Datuk Mustapa Mohamed reported in the Malaysian press that the current meningitis vaccine, the meningococcal meningitis vaccine protecting against serogroups A, C, W135 and Y imported from western countries, was not permitted by religious doctrine because it was “produced…from pig extracts.”[iv]. The reaction to such a statement was immediate: the following day the same newspaper reported the Health Ministry’s guarantee that the meningococcal vaccine was, indeed, halal. Health director-general Tan Sri Dr Mohd Ismail Merican assured the Malaysian people that the vaccine they had acquired was acceptable under Islamic law and free of any pig extracts.[v] Often vaccines are declared permissible because they have been purified of any haram materials, particularly when there is no alternatively prepared vaccine to replace it. The immediate response from the highest levels of government to allegations that the existing vaccine was haram demonstrates the unease that surrounds questionable vaccines, and the desire for vaccines that will be transparently manufactured from halal ingredients and certified to be religiously acceptable.

Such a vaccine is significant because the Muslim community has begun to apply religious dietary restrictions to more and more products that they purchase or consume, from cosmetics[vi] to vitamins[vii], causing a growing awareness of the lack of medicines that are approved under Islamic law. Such acknowledgement within Muslim communities that many vaccines available to them do not conform to their religious restrictions inspires a growing reluctance to use them. Although most vaccines are declared halal by the OIC[viii], many important ones are not. This is a growing problem, and not just for the observant who demand them, but for everyone. Vaccines that do not receive such explicit approval by religious authorities may arouse suspicion among Muslim populations, and lead to under-application of a vaccine due to either spiritual observance or doubts about its safety. The health ramifications of under-vaccination, however, are global. Diseases cross international and community borders just as easily and as frequently as the people who carry them.

Dr Abdul Majid Katme, who is head of the UK Islamic Medical Association, is one voice in the movement to reject haram vaccines. He is causing friction in England by advising the Muslim community to refrain from vaccinating its children with the vaccine for measles, mumps, and rubella[ix]. While many would wish to dismiss Katme’s position as extreme, he is an influential figure within that community. He is the head of one of the two national Islamic medical organizations, a psychiatrist in the National Health Service for a decade and a half, and a member of The Muslim Council of Britain[x]. As a doctor, he demonstrates how religious qualms with a vaccine may override the possible health risks of not taking it.

Muslim law, however, is explicit; whether a product is halal or haram should not deter someone from taking lifesaving measures[xi]. Nonetheless, observant Muslims may not consider certain vaccines an issue of life or death, as they are a form of prevention instead of treatment, and thus may refrain from using them unless acutely necessary. “Muslims,” writes Hayati Hayatudin in the Halal Journal, “are very particular about halal and haram issues” and often question whether certain products can be consumed[xii]. Hayatudin urges manufacture of common goods according to halal standards, especially in the biotechnology sector, to eliminate any doubt about whether it may be used[xiii]. Vaccines manufactured to be halal are necessary not only to encourage the most strictly observant to use them, but also to confirm that they are safe, clean, and healthy for every community.

Although Katme rejects the use of haram vaccines on religious grounds, others refuse to take them based on fears that they are dangerous or contaminated. Nigeria, for example, halted polio vaccinations between 2003 and 2006 due to rumors that the vaccine was tainted to make Muslim recipients sterile and infect them with HIV, thereby reducing their population[xiv]. Hamid Jafari from the World Heath Organization (WHO) Southeast Asia office attributed the recent resurgence of polio to these "incorrect rumors" about the vaccine’s safety which were most prevalent in northern Nigeria[xv]. Due to international travel, particularly to Saudi Arabia during Hajj and Umrah pilgrimage seasons, the resulting under-vaccination “led to re-infection of 27 countries that had become polio free. Nineteen of those 27 countries were OIC member states. The entire world is vulnerable to the spread of polio if we don't succeed in eradication," Jafari said[xvi].

The Saudi government recognizes the health risks posed during the pilgrimage seasons and now mandates a recent vaccination of several contagious diseases, including meningococcal meningitis. Unfortunately, the most popular, quadrivalent meningitis vaccine addresses only serogroups A, C, Y and W135[xvii], providing no protection for meningitis B. The later strain, however, accounted for 28 percent of meningitis cases among Saudi children under five years old, which were traced to outbreaks during the 2000 and 2001 Hajj seasons, according to a study published in Oxford University’s Journal of Tropical Pediatrics[xviii]. Although Finlay Institute’s meningitis B vaccine has proven to be remarkably effective against that illness, and has even shown signs of helping vaccinated patients make antibodies that protect against other strains of meningitis[xix], Muslim pilgrims rarely receive the vaccine due to political or religious barriers. This creates a health risk both within Saudi Arabia and within each home country. In 2006 alone, 2.3 million pilgrims participated in the Hajj rituals[xx], with over 1.6 million people entering Saudi Arabia from 187 countries[xxi], posing a global danger from such an infectious illness.

Malaysia, a country where over 60 percent of the population practices Islam[xxii], hopes to address that problem. Its biotechnology efforts are leading the way in making medicines and vaccines that conform to Islamic regulations. The Malaysian subsidiary of Bioven Holdings Sdn Bhd, experts from the Universiti Sains Malaysia, and the Finlay Institute in Cuba are developing the first vaccine to be certified, manufactured, and marketed internationally as a halal product[xxiii]. Although Cuban biotechnology efforts have already produced a highly effective meningitis B vaccine, it is now investing 1.6 million Malaysian ringgit, or about $480,000, to produce it from halal ingredients and, thus, introduce it into the Islamic market with the help of its Malaysian counterparts, who put forth 2 million ringgit, or about $600,000, for the project[xxiv]. It is hoped that a vaccine manufactured specifically to be halal will foster the trust necessary to encourage more widespread use of the drug, thereby limiting outbreaks worldwide and improving global public health safety.

Cuban biotechnology efforts have already managed to produce the world’s first synthetic vaccine for human beings. In 1999, the University of Havana and the University of Ottawa jointly patented a vaccine for haemophilus influenzae type B (or Hib), which causes the meningitis B infection. This vaccine was the first to be made with a chemically produced antigen, which is “the smallest substance that antibodies need to recognize so that they can trigger the immune system to take action”[xxv]. A chemically produced antigen allows the body to produce antibodies without exposing it to the actual bacteria that produces the disease[xxvi]. That means the Hib vaccine uses no bacteria culture and, therefore, does not need animal tissue to harvest it. Thus, Cuban and Canadian scientists have opened the door for safe and effective vaccines that require no animal parts to produce, making them automatically conform to the dietary restrictions of every religion- an innovation that may be applicable to more vaccines in the future.

Nonetheless, for a country with a little over 1,000 Muslims[xxvii], one might find it surprising for Cuba to commit its scant resources to developing a halal vaccine. Cuba’s focus for decades has been to bring health to the underserved, whether through sending doctors to remote or inhospitable areas, or working to treat diseases that private companies ignore, like cholera and hepatitis B[xxviii]. Recently, however, the island is finding ways to market its health products internationally, allowing for an inflow of currency that is much needed to sustain their universal health care system, particularly in the face of the economic collapse of the 1990s. Indeed, Dewi Hartaty Suratty, head of the Halal Certification Strategic Unit at Majlis Ungara Islam Singapura (MUIS), estimates the global market for all halal goods to be worth more than $560 billion[xxix], with an increasing portion of that market demand going towards non-food items, such as pharmaceutical and cosmetic products. With these new adjustments, the meningitis B vaccine can now serve a much wider and often ignored population, observers of Islamic law, thereby offering a solution to a major health risk, while at the same time providing the opportunity for Cuba to gain economically from its discovery. A halal meningitis B vaccine would not only stem the incidence of meningitis, particularly during pilgrimage seasons, it would also pave the way for more vaccines that are sensitive to religious and dietary restrictions, showing that such an endeavor can be profitable for pharmaceutical companies and beneficial for global public health.

Written by: Danielle Barav