PANDEMIC INFLUENZA TREATMENT NEEDS A MODERN, GENERIC APPROACH, REFORMER SAYS

PANDEMIC INFLUENZA TREATMENT NEEDS A MODERN, GENERIC APPROACH, REFORMER SAYS

By Stas  Margaronis,  RBTUS

During the 2009 swine influenza pandemic, more than 90% of the world’s people had no access to timely and affordable supplies of pandemic vaccines and antiviral agents. Instead, they had to confront the pandemic using 19^th century “public health technologies;” for example, no hand shaking and social distancing. David Fedson believes there is another and more equitable way to manage a global pandemic. This involves using inexpensive and widely available generic drugs. Instead of targeting the virus itself, these drugs would modify the host response to infection and improve survival.

Fedson’s role model is Yusuf Hamied, the head of Cipla, a generic drug maker based in Mumbai, India. Fedson said, “A decade ago, Dr. Hamied showed that HIV treatment could be made more affordable and more available to millions of people who could not afford expensive drug treatments for AIDS. In my opinion he deserves consideration for a Nobel Peace Prize.”

Wikipedia says, “In February, 2001, Cipla stunned the HIV/AIDS and public health communities by announcing it would make its triple cocktail of antiretroviral drugs available in developing countries for $350 per patient per year, a tiny fraction of the prices prevailing internationally at the time.”

Ten years later, looking back on the rapid growth in access which ensued, the Journal of the International AIDS Society (IAS) would write: “Cipla’s dramatic price reduction, which received widespread media attention, hammered the message home that many of the multinational drug companies were abusing their market monopoly in the face of a catastrophic human disaster.”[1]

The Financial Times says Hamied has become a hero to millions in Third World countries as a result of his efforts that reduced the mortality caused by AIDS:

“Cheap drugs are big business in India, as well as a source of fierce debate. Among the country’s manufacturers of cut-price generic “copies” of other pharmaceuticals’ products, Cipla, which makes Triomune, has caused the greatest controversy. Cipla makes its products by circumventing other companies’ patents, a tactic that has turned Cipla into the largest supplier of antiretroviral drugs in the world.”

The last two decades of the 20th century saw a scientific revolution in the development of antiretroviral drugs for AIDS. But it is Hamied’s combination of commercial savvy and public health vision that has translated these clinical advances into accessible treatment for HIV patients in developing countries.

To his supporters, Hamied has saved countless lives by making medicines affordable. But to his critics – above all the large western pharmaceuticals who first developed the drugs – he is a “pirate”, an opportunist who has exploited others’ intellectual property to swell his own profits. In the process, they say, he is undermining investment in future medicines, including the next generation of HIV therapies.

As the debate about generic copies gained momentum, India introduced tougher patent rules in 2005, and Hamied’s fellow generic producers have aligned themselves with western rivals to defend patents. Their aim now is to develop and safeguard their own innovative medicines. These changes are a threat to Cipla’s business model – and to the cheaper drugs. Hamied says: “I am not against patents, but India cannot afford them. I am against monopolies.”[2]

More recently, Cipla has challenged the makers of influenza anti-viral treatments such as Tamiflu that Fedson says are very expensive and won’t be available to people outside of Europe and North America where governments maintain stockpiles in case of emergency. The result, according to Wikipedia was:

“In December 2008, Cipla won a court case in India allowing it to manufacture a cheaper generic version of oseltamivir that is marketed by Hoffmann-La Roche (Roche) under the trade name Tamiflu.” In May 2009, Cipla won approval from the World Health Organization certifying that its drug Antiflu was as effective as Tamiflu, and Antiflu is included in the World Health Organization list of prequalified medicinal products.” [3]

Fedson has discussed with Hamied the possibility of using generic statins and other similarly inexpensive drugs produced by Cipla for pandemic treatment. Cipla currently distributes its products to 171 countries, and because these drugs are already being used to treat patients with cardiovascular disease and diabetes, they would be available in virtually all countries on the first pandemic day. But Hamied is a businessman, and he would need an outside institution such as the World Health Organization to support the purchase and stockpiling of the active pharmaceutical ingredients for making these drugs. Once a pandemic emergency had been declared, additional quantities of these drugs could be quickly produced and deployed around the world.

For the past year, influenza virologists and bio-security experts have been engaged in a contentious debate over research on the transmissibility of H5N1 influenza viruses. Fedson and his colleague Steve Opal have said that this debate overlooks the greater need to develop practical measures for actually managing the consequences of a global pandemic.[4]

Fedson has been arguing for years that influenza vaccines are expensive, difficult to develop quickly, require complex systems for vaccinating populations, and simply won’t be available in time to prevent the infection of millions of people during a global influenza pandemic. In the mid-2000s, he and the late Peter Dunnill, Professor of Biochemical Engineering, University College London, warned that expensive vaccines and drug treatments would save few lives in an influenza pandemic. They advocated using generic drugs such as statins to treat patients with severe illness. Fedson notes that a study of patients hospitalized with laboratory-confirmed influenza during the 2007-2008 flu season showed that statins reduced deaths by 41% compared to conventional treatment.[5]

Unfortunately, Fedson says, many influenza researchers continue to ignore the potential of statins. He says that if the avian flu virus ever became human-to-human transmissibility, it could have a mortality rate as high as 60%, so preparations need to focus on identifying affordable drugs that might improve survival and could be rapidly produced and distributed worldwide.

Statins have a track record that is getting stronger all the time: “We have known for several years that because of their broad effects on the host response, statins reduce mortality from cardiovascular diseases. This is a huge, positive sign of where we need to be going. The use of statins has the potential for generating an affordable and worldwide response to a global pandemic. As good as they are, vaccines and anti-viral drugs won’t be able to do this.”

Fedson and Opal argue that in addition to arguing about H5N1 transmissibility research, influenza scientists and bio-security experts should spend more time finding ways to modify the host response to infection and improve survival.

Fedson’s bottom line is that conventional thinking will have to be set aside if we are to find practical solutions to managing the next influenza pandemic. What Yusuf Hamied and Cipla have done for generic HIV drug treatment tells us what we need to do.