Risk, cost shrivel vaccine makers Bush asks few players left to develop protection against avian flu

1. Risk, cost shrivel vaccine makersBush asks few players left to develop protection against avian flu By Tricia BishopBaltimore Sun http://www.baltimoresun.com/news/health/bal-bz.vaccine09oct09,1,1881147.story?coll=bal-health-headlines

2. Vaccine Industry • When President Bush met with vaccine makers at the White House Friday to prod them toward vaccines against the deadly avian flu, his pleas fell on few ears. • The vaccine industry in America has been in steady decline over the past four decades, to five companies last year from 26 in the late 1960s. • Experts say the recent shortages of vaccines against even seasonal flu are a result of the slide, precipitated by lawsuits and major changes in the pharmaceutical business.

3. Shortages • Since 2000, shortages have cropped up in nine of the 12 required childhood vaccinations in the United States. During the past two years, shortages of seasonal flu vaccine have grabbed the attention of public health officials and politicians. The avian flu threat, with the potential to kill many thousands, heightens concern. • "It's just too high-risk for a potentially low return on investment," said Christopher-Paul Milne, assistant director of the Tufts Center for the Study of Drug Development in Boston. • Businesses are less and less interested in vaccines because the process is expensive, the market is much smaller than for other drugs and the legal liability risks are great, various experts said. • Lawsuits filed against vaccine makers have cost hundreds of millions of dollars to fight.

4. The Industry • Vaccines, and those who make them, were once heralded as miracle workers, responsible for saving millions of lives. But the sector has lost some prestige and focus as the population has gotten more used to living without many infectious illnesses and drug-makers turned to more profitable ventures. • Pfizer Inc.'s cholesterol medication Lipitor, for example, generated sales of $11 billion last year. Worldwide vaccine sales, on the other hand, are estimated at less than $8 billion. • Lawmakers in recent years have introduced bills to lessen the burden on manufacturers and draw new companies to the sector, but they haven't succeeded. Industry analysts think the threat of a pandemic from avian flu and the recent interest in the topic from the president, who spent his last vacation reading up on the great influenza epidemic of 1918 that killed millions, may give a boost to legislative remedies.

5. Factors that Discourage Vaccine Making • Small market for vaccines compared with drugs. • Effect of mergers. • Dramatic reduction in the private vaccine market. Today the largest single U.S. purchaser of vaccines is the federal government through the Vaccines for Children (VFC) program. • Low or inconsistent insurance reimbursements. • Lack of infrastructure support - reimbursements by insurance companies for vaccines, including "administration fees," were about 5–10 percent above the cost of the vaccine, compared with a 300 percent markup for vaccines when the private market consisted of direct out-of-pocket payments. http://content.healthaffairs.org/cgi/content/full/24/3/622

6. More Factors • Regulatory issues: moving from relative to absolute safety. The current culture does not allow for any serious side effects from a vaccine. As a consequence, pharmaceutical companies are now asked to disprove even very rare adverse effects prior to licensure. • Product liability. Vaccines were the first group of medical products that were nearly eliminated by lawsuits. In 1974 a British researcher published a paper claiming that the pertussis vaccine caused permanent brain damage in 22 children. • Pertussis, also known as whooping cough, is an infection of the respiratory system caused by the bacterium Bordetella pertussis (or B. pertussis). It's characterized by severe coughing spells that end in a "whooping" sound when the person breathes in. Before a vaccine was available, pertussis killed 5,000 to 10,000 people in the United States each year. Now, the pertussis vaccine has reduced the annual number of deaths to less than 30.

7. Still more factors! • By the late 1980s and early 1990s many investigators had examined the question raised by the British researcher and found that the pertussis vaccine did not cause permanent brain damage. The researcher’s hypothesis was wrong, but the damage was done. The number of companies making pertussis vaccine for U.S. children decreased from four (Wyeth, Connaught, Sclavo, and Lederle) to one (Lederle). • In the mid-1980s a lawsuit against Lederle claiming that pertussis vaccine caused paralysis in a young boy ended with an award of $1.13 million. This award was equivalent to more than half of the entire pertussis vaccine market. Although there was no scientific evidence to support the claim, pharmaceutical companies looked at this situation and decided to leave the vaccine business.