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Vaccine Research Needed
  We're Running Out of Time
It's been difficult to persuade the private sector to invest in vaccines. Unlike a drug that patients may have to take for a lifetime, an effective vaccine is a 'one-shot' deal.

By Dr. Seth Berkley
Aids Vaccine Initiative.
Newsweek International
Jan. 30, 2006 issue - One of the hottest topics at this week's world economic Forum in Davos is sure to be pandemic preparedness. With new avian-flu cases surfacing in Asia, Turkey and Iraq, battling an H5N1 human-flu strain with adequate surveillance, drugs and vaccines has become almost a global obsession. After last week's donors conference in Beijing, international pledges, bolstered
most recently by the European Union and Japan, are now nearing $2 billion. But a key question remains: are we a day late and a dollar short in preparing for a potential flu outbreak?
The experience of the last decade in searching for a vaccine to combat another global killer-AIDS-suggests a number of glaring weaknesses in our approach to such health emergencies. Both diseases could lead to a death toll in the hundreds of millions. The avian-flu pandemic in 1918 killed an estimated 50 to 100 million; HIV has already claimed more than 25 million lives and another 40 million people are currently infected. Both diseases are caused by viruses that are constantly mutating and therefore unpredictable. Drug treatment for both is expensive, difficult to access and becomes ineffective over time as the ever-evolving viruses become resistant. This season's garden-variety flu, for example, has quickly become immune to the drugs amantadine and rimantadine, sending public-health officials scurrying for new alternatives. Countries like Brazil are spending a substantial and increasing proportion of their AIDS resources on expensive second-line therapy for patients who no longer respond to first-line methods.
Overcoming the biomedical obstacles to an AIDS vaccine is perhaps the toughest public-health test of our time. But a large part of the challenge thus far has been a matter of policy. Most of the expertise in developing vaccines is held by Big Pharma. Yet it's been difficult to convince the private sector to invest in vaccines-traditionally high-volume products that provide relatively low return on investment. Unlike a drug that patients may have to take for a lifetime, an effective vaccine is literally a "one shot" deal-there are virtually no repeat customers.
Uncertain demand raises yet another obstacle. In the case of AIDS, poor villagers in Africa and India and their governments may not be willing or able to pay for an expensive vaccine, so the precise number of doses needed worldwide remains unclear. With flu, public-health officials don't know when the next pandemic outbreak will occur or how many people will be affected. The current endemic flu vaccines must be updated each year-which makes it hard for manufacturers to plan ahead-and companies have not had adequate incentives to invest in newer technologies. Over all this looms the threat of massive liability lawsuits. That concern will become particularly acute if companies are put on a "fast track" to develop, test and manufacture an avian-flu vaccine-as currently proposed by the World Health Organization, the U.S. Department of Health and Human Services and European health agencies.
At the same time, our experience with AIDS provides lessons beyond the cautionary ones. First, we need more public funding for researchers and industry to overcome scientific roadblocks, with an emphasis on applied research. This money needs to come quickly and be free of bureaucratic encumbrances. In this regard, U.S. President George W. Bush's proposal of nearly $3 billion to accelerate development of cell-culture technology for an H5N1 vaccine is a step in the right direction. Workbench-to-bedside vaccine R&D is also needed for AIDS and other diseases.
Second, we need a range of government-sponsored financing schemes to bring the private sector to the table. Government funding for public-private partnerships that bring public interest and money together with industry expertise can make a difference. Guarantees to pay a fair price to companies that successfully produce a flu or AIDS vaccine for poor people in Africa, Asia and Latin America could give companies important incentives and confidence that there would be significant demand for their product-in effect creating a larger global market.
Third, liability protection or public insurance that balances legitimate consumer interests with companies' concerns about large and damaging lawsuits could also help overcome industry reluctance. Simplified regulatory procedures should help promote the rapid approval of new vaccines. Twenty-three years after the discovery of HIV and more than a decade after scientists first raised concerns about a lethal avian flu, the time has come for us to put in place a new accelerated system for finding and producing the vaccines we need to end these global health disasters. Future generations will judge us on this.
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