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