TCS Daily


The Flu the Next Time

By Duane D. Freese - November 17, 2005 12:00 AM

President Bush's plan to combat the threat of avian flu is borne of fears that the H5N1 viral strain closely resembles the 1918 flu strain that had leapt from birds to humans, killing 500,000 Americans and 20 million people worldwide. A report by the Department of Health and Human Services after the unveiling of Bush's plan warned that as many as 1.9 million Americans could be killed in a new pandemic with a third of the population becoming infected.

As protection, the administration's plan proposes spending $1.2 billion to vaccinate 20 million Americans with the current strain of avian flu. The idea is to give key emergency personnel some limited immunity to a mutated pandemic strain while a vaccine is prepared for the actual strain. To increase the ability to create enough of that kind of vaccine, the Bush plan would invest $2.8 billion in research and development of a cell-based (versus egg-based) vaccine, making it possible to inoculate everyone within six months of an outbreak.  

That new technology, though, won't be ready until 2010 at the earliest. In the interim, and even after it's available, the first line of defense will be antivirals for most people. Antivirals given within 48 hours of onset of flu symptoms can in many cases relieve the worst of those symptoms, which in the case of the avian flu means it can prevent a lot of deaths.  

The Bush plan calls for buying enough to treat about 44 million Americans, about 15% of the population, and expects states and local governments to kick in and buy enough to cover another 10% or so.  

What antiviral to buy? The primary one, though not the only one needed, would be Tamiflu. This drug from California-based inventor Gilead Sciences is licensed for production by the Swiss pharmaceutical firm Hoffmann-La Roche. Tamiflu has been shown to reduce mortality in the avian flu strain that is of concern, at least in mouse models; and it can be made in a form that is easy to take and has a long shelf live.  

Roche began expanding its supply chain after contacts with the Department of Health and Human Services in 2003, and the Food and Drug Administration recently approved a new U.S. manufacturing site.  
That said, Roche doesn't have the capacity and won't have the capacity to produce enough to meet the administration's goals for some time.  

New York Sen. Charles Schumer recently criticized President Bush's pandemic plan flu for failing to provide antiviral medicine for enough Americans soon enough. Schumer wants the country to follow the lead of some European countries that are seeking to acquire enough to cover 40% of their populations, a level that health experts believe would be safer yet.  

All indications are that if you want to really keep a pandemic from getting out of hand and killing hundreds of thousands of people, you're going to need a lot of antiviral at the ready. That's because pandemics run in waves. They can come in two or three over several months. And antivirals only work as long as your taking them, unlike vaccines that offer longer range immunity.  

Further, Tamiflu is a rather complicated formula to make, according to Roche. It requires a 10-step production process that can take six to eight months to complete once all materials are on hand. And one key ingredient, shikimic acid, from the star anise plant, is in limited supply.  

So, it isn't like you can simply churn out enough additional antiviral really quickly to meet the needs of a nation of 300 million. You have to have it on hand so people can take the full regimen when they need it. If you take less than the prescribed full course, as with anything with drugs, you can encourage mutation into resistant strains.  

While Sen. Schumer's concerns are understandable, he proposed the wrong solution to resolve the problem. He threatened Roche with legislation requiring compulsory licensing -- essentially breaking their patent rights. He drew back from that threat when Roche then met with a key New York state generic drugmaker, Barr, to discuss licensing production of Tamiflu here.  

With numerous generic drug makers' offices and facilities in his state, Schumer's actions are nothing unexpected - it's a typical political sop to constituents at the expense of others. He made the same threat of legislation against the German pharmaceutical giant Bayer over the anti-anthrax drug Cipro at the height of the post 9/11 anthrax scare. And the Bush administration went along, too. It threatened Bayer until Bayer agreed to cut a deal for cut-rate prices.  

The Cipro episode created a field day for anti-pharmaceutical industry zealots, such as Jamie Love of the Consumer Project on Technology, a Naderite group, who told the San Francisco Chronicle: "The Cipro thing was timely. When the US did not like the price of a medicine, we were very fast to say we might override patent rights."  

In the current imbroglio with Roche, Love is beating the drums again: "I think it is pretty clear that Roche intends to suppress generic production as much as it can get away with. A failure to issue compulsory licenses liberally will result in a slower response by the generic industry to the capacity and supply problem, and much higher prices, and smaller stockpiles. The private market is likely to be particularly important for those who cannot realistically depend upon governments to protect them." There is nothing Love and the others would like more than to break the current reluctance of developed nations to force licensing of patented medicines to generics manufacturers.  

But a failure by the Bush administration and the wealthy western countries to protect property rights for life-saving medicines would be disastrous.  

As Bill Gates, whose foundation is providing billions for health programs worldwide, recently noted: "When you think about developing world health, the price of drugs is not the key issue. It's the drugs that aren't being invented, and part of the reason they aren't being invented is that [if] the pharmaceutical companies work in these areas, then they're expected to give the drugs away."  

In a new study Avian Flu: What Should Be Done, economist Tyler Cowen argues that respect for property rights and paying fair prices for drugs are especially important if new drugs are to be available for future pandemics, whether the long lasting AIDS pandemic or of the shorter duration but equally kind an avian flu pandemic might pose.  

"Confiscating property rights would reduce the incentive for innovation the next time around," Cowen argues. "Moralizing aside," he goes on, "the future supply of antivirals and other drugs still will depend on expected profits. ... If we eliminate or reduce such profits, we can expect less innovation in the future."  

So, Sen. Schumer's reaching immediately for the compulsory licensing threat was not good -- not for the United States or for defeating the pandemic.  

The good news, though, is that Roche has agreed to work with the administration to meet its stockpile needs, and has settled its dispute with Gilead, which can now become one of the partners it needs in an appropriate expansion of the production of the drug.  

But governments must make sure appropriate incentives are in place so that will happen. As Cowen points out, stockpiles of any particular anti-viral is no solution to a  pandemic. It is more important to decentralize supplies and provide timely distribution of any drugs that might be helpful in battling the disease. In short, don't count on any drug being a silver bullet. It is ridiculous that governments worldwide focused so much attention on getting cheap drugs that they failed to promote the invention, development and distribution of those medicines needed to meet a deadly outbreak of avian flu.  

Either way, the tough Love approach of whipping drug makers into releasing one drug, and in the process discouraging the production of better ones -- or drugs for the next potential pandemic, whatever it may be -- is no solution.
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