Health Biz: Vaccines face unsure markets

WASHINGTON, May 24 (UPI) -- The pharmaceutical industry's enthusiasm for vaccine research and development does not seem to match fears by healthcare providers and analysts of an avian flu pandemic or supply shortages in the United States.

Ed Howard, of the non-profit, non-partisan Alliance for Health Reform, said 18,000 people die each year because they do not have health insurance, but millions of lives are lost because people are not properly vaccinated.

"Vaccines need to be developed, they need to be manufactured, they need to be distributed and there are policy challenges in every one of those areas," he told an Alliance-sponsored briefing on vaccines. "We're talking here about a high-profile life and death issue at stake."

Big Pharma does not ignore vaccines -- it is just that the vaccine marketplace is iffy given the $800 million or so in R&D costs required to develop and launch a new product.

"Pharmaceutical companies are businesses, not public-health agencies, and vaccines are not particularly a lucrative business," said Dr. Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia and director of the Vaccine Education Center.

Each year, millions of flu-vaccine vials are destroyed because not enough people receive them. Vaccines are basically a one-shot deal, compared to blood-pressure pills, which people buy and take daily for years.

A blockbuster drug to cure cancer creates a striking visual image -- a critically ill child recovers and lives a normal life -- but it is impossible to show the public the effects of vaccination. The past half-century has seen vast success in eradicating many horrible diseases, such as polio and smallpox, and the tragedy they once caused is a distant memory for most.

People who are vaccinated these days simply do not get sick -- there is no before and after to help quantify efficacy and push vaccine sales.

People will take medication readily to get well, but often do not see or believe the risk to themselves or their children not being properly vaccinated can bring.

These are just some of the reasons why, as Offit said, vaccines do not exceed 6 percent of total revenue at any of the handful of companies still making and selling them.

When the flu pandemic hit the United States in 1957, there were 26 companies that manufactured vaccine products. Today, there are four pharmaceutical companies making vaccines worldwide.

In describing the "crumbling of the vaccine infrastructure," Offit noted of the 12 vaccinations currently and routinely recommended in the United States, nine have been in short supply over the past few years and seven are made by just one company.

The federal government -- through the Vaccines for Children Program and Immunization Grant Program -- Section 317 programs -- buys about 60 percent of the U.S. vaccine supply, but there are problems with inadequate funding for programs that provide the vaccines to the public. Some 19 states did not have enough money in 2003 to provide pneumococcal conjugate vaccine for all their target children.

Liability issues also remain a problem, despite a compensation program created to limit pharmaceutical company exposure in cases where vaccines produce unexpected side effects.

Offit said the compensation program only covers routinely recommended vaccines, leaving niche vaccines -- such as those to help AIDS patient with secondary diseases -- without protection.

The technology is available, for example, to protect newborns against a potentially fatal form of strep acquired in the first week of birth, Offit said. "We have technology in hand to prevent it, but no company is going to step forward to prevent that disease because it would mean giving the vaccine to a pregnant woman, which in this country can't happen because of fear of litigation."

Big Pharma's drug pipeline is not empty of vaccine candidates. Dr. Walter Orenstein, director of the Program for Vaccine Policy and Development at Emory University in Atlanta, said a new acellular pertussis vaccine has been licensed for children and a meningococcal conjugate vaccine has been licensed for adolescents. A shingles vaccine has shown promise in clinical trials, a rotavirus and a human papilloma vaccine for cervical cancer are expected to be approved soon in the United States.

"We'll know the crisis is officially here in force if one of two things happen," Offit said. "Either those vaccines are recommended for routine use but Congress balks at funding them fully through the VFC program or the 317 state programs, or worse if -- I think this would be much worse -- the advisory committee for immunization practices (at the Food and Drug Administration) or the American Academy of Pediatrics balks at making what is the best medical recommendation for fear of testing Congress' resolve to support these programs."

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These issues in vaccine development for U.S. use constitute only half of the problem. The next Health Biz will cover Pharma's vaccine challenges in developing countries.

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E-mail ebeck@upi.com