ASIANS THE NEW GUINEA PIGS FOR AS DRUG TESTING
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By Gregory Lopes
The Washington Times
Saturday, December 8, 2007
Asia is becoming the new testing ground for companies
looking for the next blockbuster drug, a development that
will shorten the time it takes for pharmaceutical products
to enter the U.S. market in the coming years, drug industry
experts say.
In a period of escalating costs at home, conducting
clinical trials abroad allows drug companies to keep
research costs low. Also, because of large populations of
potential patients in developing countries such as India
and China, drug makers can gather data more quickly to
expedite the drug-approval process in the U.S.
"There is no question clinical research is globalizing,"
said David Lepay, senior adviser for clinical science at
the Food and Drug Administration (FDA). "It does indeed
expedite the product-development process in the United
States; that's a positive public health benefit."
The number of drug companies conducting clinical trials
worldwide jumped from 956 in 1997 to nearly 1,800 last
year, according to the Tufts Center for the Study of Drug
Development in Boston.
Ten years ago, 86 percent of all clinical trials were done
in the U.S. Today, 30 percent of clinical trials are done
in countries outside the U.S. and Europe, and only 57
percent are done in the United States.
Meanwhile, the FDA is taking steps to increase its drug-
approval rate. The total number of blockbuster drugs
approved by the FDA is expected to rise from 94 in 2005 to
112 in 2007, IMS Health estimated. Potential blockbusters
that are expected to debut next year include Johnson &
Johnson's paliperidone for schizophrenia, Wyeth's
desvenlafaxine for depression and Novartis' Galvus for
diabetes.
But drugs will reach the U.S. market faster if the trend
toward more overseas clinical trials continues, drug
industry experts say.
"This trend will result in more drugs available to U.S.
consumers faster," said Linda Bannister, a financial
analyst for Edward Jones.
It is too early to point to specific drugs that got their
start abroad, but the foundations are being put in place.
For example, GlaxoSmithKline just established a
collaboration with India's top six cancer centers and built
a research and development center in Shanghai. In 2006,
large drug companies such as GlaxoSmithKline and Roche
doubled research and development spending in China and
India from the previous year to $2.2 billion.
The cost of conducting a clinical trial in China can cut in
half the cost of that same trial in the U.S., according to
a report by AT Kearney, a management consulting firm.
Cheaper labor and site fees contribute to the lower price
tag.
Ken Getz, a research fellow at the Tufts Center for Drug
Development, said there has been very little criticism of
drug companies taking their research abroad. However, he
said, there is concern among physicians over whether the
clinical data gathered overseas can be generalized to
patients in the U.S.
"There will be greater discussion about whether a guideline
should be created that restricts the proportion of patients
abroad tested for drugs that will be introduced on the U.S.
market," he said.
In response to the trend and to solidify the public's trust
in drugs that are researched abroad, the FDA is updating a
nearly 30-year-old regulation that outlines the use of
international clinical trial data for drug approval in the
U.S. The agency has accepted clinical trial data from
outside the U.S. since 1980.
"We expect the safety regulations for drug approvals that
we have here at home will be required abroad," Mr. Lepay
said.
Foreign drug makers are out in front of U.S. drug companies
in tapping into the immense patient populations in overseas
countries, according to drug industry experts. In addition
to the efforts of Britain"s GlaxoSmithKline and
Switzerland"s Roche, AstraZeneca in England and Novartis of
Switzerland have announced plans to spend $100 million on
pharmaceutical research in China.
With $29 billion worth of drug patents set to expire in the
next two years and $160 billion worth by 2015, U.S. drug
companies are fast on the heels of their foreign
competitors to fill their product pipelines. Eli Lilly, in
Indiana, recently announced that it will spend $300 million
in China over the next five years.
"U.S. companies will want a hold out there for future
growth opportunities," said Tony Farino, leader of U.S.
Pharmaceuticals & Life Sciences Advisory Services at
PricewaterhouseCoopers. "U.S. markets continue to be
important, but Asian markets are rapidly becoming more
important because there is a tremendous amount of people
with chronic conditions that are not on medication."
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