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

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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.vac
cine09oct09,1,1881147.story?collbal-health-headli
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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.

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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.

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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.

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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 510 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.

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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.

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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 researchers 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.