US cancer researchers go abroad for trials
- From: E.Nigma <NoReply@xxxxxx>
- Date: Sat, 29 Dec 2007 19:00:07 +0000 (UTC)
By Emily Anthes and Scott Allen, Globe Staff | December 29, 2007
http://www.boston.com/news/nation/articles/2007/12/29/us_cancer_researc
hers_go_abroad_for_trials/
It was one of the biggest advances in cancer treatment this year, a
drug combination that potentially adds years to the lives of patients
whose colon cancer has spread.
But the research that led to the finding could never have been
conducted in the United States, because most Americans wouldn't have
been willing to participate in a trial, like this one, where there was
a strong chance that they would be assigned to a group that did not get
the experimental chemotherapy.
"We wouldn't even try it," said Dr. A. William Blackstock, a North
Carolina radiation oncologist who serves on a federally funded
committee that promotes cancer research.
Thirty-six years after the United States declared "war" on cancer,
scientists are increasingly fighting its battles in other countries,
where doctors have an easier time persuading patients to take part in
experiments and ethical rules for human research are sometimes looser.
About 43 percent of all US-regulated clinical trials are now conducted
outside the country, according to a new study by the Tufts Center for
the Study of Drug Development.
The move offshore reflects a numbers problem in the United States:
Though more than 1.4 million people were diagnosed with cancer in 2007,
fewer than 5 percent of them enrolled in clinical trials of
experimental drugs. Many don't enroll because they are wary of
potential side effects or fear that the drugs could turn out to be
ineffective or inferior to conventional treatments. In contrast, others
worry about being assigned to a comparison group that doesn't get the
experimental treatment. And some aren't aware of trials for their
specific condition.
Such low participation is one reason it can take 15 years, or longer,
to develop new cancer treatments. Four-fifths of US clinical trials are
delayed because researchers can't find enough people to fill them.
When Barbara Holtz, of Wayland, was diagnosed with breast cancer in
2001, even physicians in her own family advised against participating
in a clinical trial because of the risks of taking an unapproved drug.
She ultimately decided to participate in the trial anyway, largely
because she wanted to contribute to science.
"One of my commitments here is my faith in the scientific process, my
belief in wanting to move science along," she said.
Even though Holtz had to drop out of the study because of concern about
the drug's impact on her heart, she said the experience was positive
and that she'd do it again - a sentiment that is typical of people who
take part in drug trials. They report getting excellent care in
surveys, and some say the experimental treatments they received were
superior to conventional care.
But analysts who track cancer research say that faltering public
confidence in the drug industry, which pays for most human tests of
cancer drugs, is likely to hold down participation rates.
"We have seen a real erosion of public trust in the clinical trial
enterprise," said Ken Getz, founder of the Center for Information &
Study on Clinical Research Participation, a Dedham-based nonprofit
group. "Only 14 percent of the American public believes that
pharmaceutical companies are honest - that puts them on par with the
tobacco and used-cars industries. That's really a dramatic change for
the worse."
This public skepticism comes at a time when the demand for patients to
test cancer medications is exploding.
Not only has the number of anti-cancer drugs under development grown
from 400 in 2001 to 650 last year, but federal regulators are also
pressing researchers to include more patients so that trials more
reliably pinpoint possible side effects. As a result, the number of
patients needed to fill industry-sponsored trials for all kinds of
medications grew from 2.8 million people in 1999 to 19.8 million in
2005, according to BBK Worldwide, a patient recruitment company in
Newton.
Also, because trials are usually aimed at patients suffering a very
specific form or stage of cancer and who meet strict eligibility
requirements, the vast majority of volunteers are rejected.
In Boston, where so much clinical research takes place and ads for
volunteers line the inside of subway cars, patients are more likely to
volunteer, Getz said, but, even here, trials aren't necessarily any
easier to fill, because there are so many researchers competing for the
available cancer patients and patients can typically enroll in only one
trial at a time.
The shortage has forced researchers to look increasingly abroad, where
patients are more likely to sign up because experimental cancer
treatments give them a chance to be treated at top medical centers and
get more aggressive care. Trials with recruits from other countries
fill 40 percent faster than those limited to patients in the United
States, according to BBK, and trials carried out in developing nations
cost less, too, since the investigators and support staff are not paid
as much as their American counterparts.
But the globalization of trials carries ethical risks. Poor, less-
educated people in developing nations are more vulnerable to
manipulation. For instance, "in India, physicians exert far more
influence over a patient decision than you're going to see in most
parts of the US," said Joan Bachenheimer, the cofounder of BBK,
suggesting that some subjects may feel pressured to participate.
And it can be harder to assure quality control in developing nations,
although officials at the US Food and Drug Administration hold foreign-
based scientists to the same scientific and ethical standards that they
would in the United States.
In Europe, where the problems of developing nations don't apply,
researchers say they find that patients are more willing to accept risk
for science than in the United States.
In France, a study of patients whose colon cancer had spread to their
livers was challenging to organize because it required desperately ill
people to risk forgoing the experimental chemotherapy if they were
randomly assigned to a comparison group of patients who would get
surgery but not the drug combination. It took several years and help
from medical centers across Europe and Australia, but, in the end, the
team, led by Paris surgeon Bernard Nordlinger, recruited 364 patients
willing to take part. That allowed him to demonstrate that chemotherapy
before and after liver surgery boosted patients' survival chances by 25
percent.
By comparison, Blackstock of Wake Forest University Baptist Medical
Center said his National Cancer Institute-funded committee has
struggled to design a similar study that American patients - and their
doctors - would support.
To increase American participation, Getz and Bachenheimer both say the
medical community must increase awareness of clinical trials and
explain to the public that participants fare as well as patients
receiving conventional treatment, and sometimes they do better.
Currently, three-quarters of the general public say they have "little
to no knowledge" of trials or how to take part.
Terry Barter, 59, enrolled in a clinical trial at the Dana-Farber
Cancer Institute to avoid the invasive stem-cell transplant his first
two oncologists recommended. Every two weeks for five years, Barter,
who had been diagnosed with multiple myeloma, an incurable blood
cancer, made the 40-mile drive from his home in Berlin to Boston to be
examined and have blood drawn for the study.
But the sacrifice, he says, was worth it.
Before the trial, his doctors had told him that he had only two years
to live if he didn't get a stem-cell transplant. He went to Italy and
bought himself a Corvette. But the experimental drug he took drove his
cancer into remission. It's now been seven years since his diagnosis.
"I did all these things I wanted to do before I left this Earth," he
said. "And now it looks like I'm not leaving."
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