Dr. William I. Wolff, who with a colleague revolutionized the
diagnosis and treatment of colon cancer by developing the colonoscopy as the
procedure is practiced today, died on Aug. 20 at his home in Manhattan. He was
94.
His family announced the death.
Working with Dr. Hiromi Shinya at Beth Israel Medical Center in Manhattan in the
1960s, Dr. Wolff was at the forefront of a worldwide research effort to develop
ways to probe the full length of the colon using a tube with electronic sensors.
Their most significant advance was the development of a device that could remove
a polyp immediately during a colonoscopy, eliminating the need for a second
procedure.
Their protocol — using one doctor for the procedure instead of two, for example
— became the universal standard, and articles they published about their
thousands of successes confirmed the safety and efficacy of colonoscopies.
Though often dreaded by patients as much as a root canal, the procedure, if done
in time, can eliminate more than 60 percent of large-intestine growths. In the
United States, more than 1.6 million colonoscopies are performed every year,
mostly as a recommended preventive procedure for adults beginning in middle age.
More than 50,000 Americans die from cancer of the colon and rectum each year,
making it the second-deadliest cancer in the United States, after lung cancer.
The colonoscope, the snakelike instrument used in the procedure, solved a
longstanding problem: it could negotiate the sharp first turn of the large
intestine. That allowed it to examine the full five feet of the organ, its
fibers lighting the colon’s walls and carrying the reflected image back to the
other end of the colonoscope, where it could be viewed by a doctor. Previous
procedures could penetrate only about 10 inches before being blocked.
Dr. Wolff and Dr. Shinya, working with the Olympus Optical Company, made a
further, groundbreaking advance when, using a design by Dr. Shinya, in 1969 they
introduced a wire loop snare to cauterize a polyp as soon as it is found, making
a second procedure unnecessary.
Dr. Francis Moore, a leading surgeon, called this “a quantum advance in
abdominal surgery.”
Dr. Wolff and Dr. Shinya first described their surgical procedure in The New
England Journal of Medicine; in 1999 the journal Seminars in Colon & Rectal
Surgery called it one of the 20th century’s dozen landmark articles in the
field.
Colonoscopy expanded through the 1970s and gained wide public exposure when the
process was used several times to remove polyps from President Ronald Reagan in
the mid-1980s. Many news articles mentioned Dr. Wolff and Dr. Shinya as the
pioneers.
The colonoscope prompted a radical shift in medical thinking. Earlier, most
doctors believed that bowel polyps rarely if ever turned into cancer. Today’s
prevailing belief is that most, if not all, cancers of the colon arise from
polyps.
The colonoscope is an endoscope, as instruments to examine the body’s interior
are known. Endoscopes were being used increasingly in the 1960s to probe
downward from the mouth or nose. Dr. Wolff was already doing this as head of
surgery at Beth Israel.
At a conference in Denmark in 1966, he became fascinated with a new fiber-optic
endoscope. He then teamed up with Dr. Shinya, who had just completed his
surgical residency at Beth Israel, to find out if the device could be used to
study the entirety of the large intestine from the bottom up.
“We now confess that we were not at all entranced with the prospect of pushing a
stiff tube through a thin-walled convoluted colon,” he wrote. “The specter of
malpractice suits loomed large, should a mishap occur.”
So his team experimented with a softer, more flexible endoscope. In June 1969,
they performed one of the first colonoscopies. Three months later, using the
electrosurgical polypectomy snare designed by Dr. Shinya, they used the
procedure to remove polyps.
They held back from publishing until they had done a minimum of 100 successful
procedures. Dr. Wolff’s subsequent articles, all in top journals, “pre-empted”
the field, Dr. Irvin M. Modlin wrote in his 2000 book, “A Brief History of
Endoscopy.”
William Irwin Wolff was born in Manhattan on Oct. 24, 1916, and moved to the
Bronx at 2. He earned a bachelor’s degree and fencing trophies at New York
University and a medical degree from the University of Maryland. He did an
internship and residency at Bellevue Hospital in Manhattan, then served as an
Army medical officer during World War II in Europe, accumulating vast surgical
experience. After being discharged as a major, he worked in surgery at veterans
hospitals in the Bronx and Butler, Pa., specializing in thoracic surgery.
While at the Pennsylvania hospital, Dr. Wolff revived a man who had apparently
died while being prepared for a lung operation. He had no pulse or heart sounds
for six minutes. Dr. Wolff opened his abdomen and massaged his heart until it
beat. It was one of the first times a clinically dead person was resuscitated.
Dr. Wolff wrote about it for The Journal of the American Medical Association,
and the news media covered it widely.
Dr. Wolff’s first marriage, to Lillian Myrick, ended in divorce. His second
wife, the former Rita Smith, died in 2007. He is survived by his sons, Richard,
David, Alan, Mitchell and George; his daughters, Deborah Wolff Dumovic, Lisa
Wolff, Rebecca Wolff and Barbara Wolff Redmond; and 16 grandchildren.
Dr. Wolff delighted in veering from conventionality. During one complex surgery,
he noticed that a student nurse was straining to see what was going on. So he
summoned her closer to watch, and even encouraged her to touch the patient’s
heart. In another case, a patient from Chinatown could pay only in homemade
dumplings, and that was fine with him.
CHICAGO
(Reuters) - U.S. cancer death rates are continuing to fall, but not all segments
of the population are benefiting, the American Cancer Society said Friday.
Overall, the group predicts 1,596,670 new cancer cases in the United States and
571,950 deaths in 2011.
Death rates for all cancer types fell by 1.9 percent a year from 2001 to 2007 in
men and by 1.5 percent a year in women from 2002 through 2007.
Steady overall declines in cancer death rates have meant about 898,000 who would
have died prematurely from cancer in the past 17 years did not, the organization
said.
Americans with the least education are more than twice as likely to die from
cancer as those with the most education, according to the group's annual cancer
report.
Death rates for all cancer types have fallen in all racial and ethnic groups
among both men and women since 1998 with the exception of American Indian/Alaska
Native women, among whom rates were stable.
Black and Hispanic men have had the largest annual decreases in cancer death
rates since 1998, falling by 2.6 percent among blacks and 2.5 percent among
Hispanics.
New cases of lung cancer among women fell after rising steadily since the 1930s.
The decline comes more than a decade after lung cancer rates in men started
dropping and reflects differences in smoking trends among U.S. men and women,
who took up smoking later in the last century than men.
Lung cancer is expected to account for 26 percent of all cancer deaths among
women in 2011 and remains the No. 1 cancer killer of both men and women in the
United States.
Breast cancer comes in No. 2 for women. Prostate cancer is the second most
common killer of men, and colon cancer is the third-leading cause of cancer
deaths for both sexes.
These four cancers account for almost half the total cancer deaths among men and
women.
Cancer rates vary considerably among racial and ethnic groups. For all cancer
types, black men have a 14 percent higher rate of new cases and a 33 percent
higher death rate than white men, while black women have a 6 percent lower rate
of new cancer cases and a 17 percent higher death rate than white women.
The report found cancer rates in the least educated were 2.6 times higher than
in the most educated. This was most pronounced in lung cancer, reflecting higher
smoking rates among those with less education.
Thirty-one percent of men with 12 or fewer years of education are smokers,
compared with 12 percent of college graduates and 5 percent of men with advanced
degrees.
(Reuters)
- About 1,6 million Americans will be diagnosed with cancer in 2011 and 571,950
will die of cancer, more than 1,500 people a day, according to the American
Cancer Society's latest report on cancer.
Cancer is the second most common cause of death in the United States after heart
disease, accounting for 1 in every 4 deaths.
Here are the latest American Cancer Society statistics on cancer in the United
States:
* Lung cancer -- An estimated 221,130 Americas will be diagnosed with lung
cancer in 2011, accounting for about 14 percent of all cancer cases. Lung cancer
rates have been falling steadily among men, and have just begun falling among
women. An estimated 156,940 men and women will die from lung cancer in 2011,
accounting for about 27 percent of all cancer deaths expected in 2011.
* Breast cancer - An estimated 230,480 women and 2,140 men will get breast
cancer in 2011. Excluding skin cancers, breast cancer is the most frequently
diagnosed cancer in women. Some 39,520 women and 450 men will die from breast
cancer in 2011. Breast cancer is the second leading cause of death among women
behind lung cancer.
* Prostate cancer -- An estimated 240,890 U.S. men will be diagnosed with
prostate cancer in 2011. Prostate cancer is the most frequently diagnosed cancer
in men, and far more black men than white men develop this cancer, although it
is not clear why. An estimated 33,720 U.S. men will die from prostate cancer in
2011, making prostate cancer the second-leading cause of cancer death in men
behind lung cancer.
* Childhood cancer -- Some 11,210 children aged 14 years and under will develop
cancer in 2011. These cancers are rare, representing less than 1 percent of all
new cases of cancer. But childhood cancer has been climbing at a rate of 0.6
percent per year since 1975. An estimated 1,320 children are expected to die
from cancer in 2011.
Among the recent research grants awarded by the National Cancer Institute is
one for a study asking whether people who are especially responsive to
good-tasting food have the most difficulty staying on a diet. Another study will
assess a Web-based program that encourages families to choose more healthful
foods.
Many other grants involve biological research unlikely to break new ground. For
example, one project asks whether a laboratory discovery involving colon cancer
also applies to breast cancer. But even if it does apply, there is no treatment
yet that exploits it.
The cancer institute has spent $105 billion since President Richard M. Nixon
declared war on the disease in 1971. The American Cancer Society, the largest
private financer of cancer research, has spent about $3.4 billion on research
grants since 1946.
Yet the fight against cancer is going slower than most had hoped, with only
small changes in the death rate in the almost 40 years since it began.
One major impediment, scientists agree, is the grant system itself. It has
become a sort of jobs program, a way to keep research laboratories going year
after year with the understanding that the focus will be on small projects
unlikely to take significant steps toward curing cancer.
“These grants are not silly, but they are only likely to produce incremental
progress,” said Dr. Robert C. Young, chancellor at Fox Chase Cancer Center in
Philadelphia and chairman of the Board of Scientific Advisors, an independent
group that makes recommendations to the cancer institute.
The institute’s reviewers choose such projects because, with too little money to
finance most proposals, they are timid about taking chances on ones that might
not succeed. The problem, Dr. Young and others say, is that projects that could
make a major difference in cancer prevention and treatment are all too often
crowded out because they are too uncertain. In fact, it has become lore among
cancer researchers that some game-changing discoveries involved projects deemed
too unlikely to succeed and were therefore denied federal grants, forcing
researchers to struggle mightily to continue.
Take one transformative drug, for breast cancer. It was based on a discovery by
Dr. Dennis Slamon of the University of California, Los Angeles, that very
aggressive breast cancers often have multiple copies of a particular protein,
HER-2. That led to the development of herceptin, which blocks HER-2.
Now women with excess HER-2 proteins, who once had the worst breast cancer
prognoses, have prognoses that are among the best. But when Dr. Slamon wanted to
start this research, his grant was turned down. He succeeded only after the
grateful wife of a patient helped him get money from Revlon, the cosmetics
company.
Yet studies like the one on tasty food are financed. That study, which received
a grant of $100,000 over two years, is based on the idea that since obesity is
associated with an increased risk of cancer, understanding why people have
trouble losing weight could lead to better weight control methods, which could
lead to less obesity, which could lead to less cancer.
“It was the first grant I ever submitted, and it was funded on the first try,”
said the principal investigator, Bradley M. Appelhans, an assistant professor of
basic medical sciences and psychology at the University of Arizona. Dr.
Appelhans said he realized it would hardly cure cancer, but hoped that “it will
provide knowledge that will incrementally contribute to more effective cancer
prevention strategies.”
Even top federal cancer officials say the system needs to be changed.
“We have a system that works over all pretty well, and is very good at ruling
out bad things — we don’t fund bad research,” said Dr. Raynard S. Kington,
acting director of the National Institutes of Health, which includes the cancer
institute. “But given that, we also recognize that the system probably provides
disincentives to funding really transformative research.”
The private American Cancer Society follows a similarly cautious path. Last
year, it awarded $124 million in new research grants, with some money coming
from large donors but most from events like walkathons and memorial donations.
Dr. Otis W. Brawley, chief medical officer at the cancer society, said the whole
cancer research effort remained too cautious.
“The problem in science is that the way you get ahead is by staying within
narrow parameters and doing what other people are doing,” Dr. Brawley said. “No
one wants to fund wild new ideas.”
He added that the problem of getting money for imaginative but chancy proposals
had worsened in recent years. There are more scientists seeking grants — they
surged into the field in the 1990s when the National Institutes of Health budget
doubled before plunging again.
That makes many researchers, who need grants not just to run their labs but also
sometimes to keep their faculty positions, even more cautious in the grant
proposals they submit. And grant review committees become more wary about giving
scarce money to speculative proposals.
Philanthropies, which helped some researchers try outside-the-box ideas, are now
having financial problems. And advances in technology have made research more
expensive.
“Scientists don’t like talking about it publicly,” because they worry that their
remarks will be viewed as lashing out at the health institutes, which supports
them, said Dr. Richard D. Klausner, a former director of the National Cancer
Institute.
But, Dr. Klausner added: “There is no conversation that I have ever had about
the grant system that doesn’t have an incredible sense of consensus that it is
not working. That is a terrible wasted opportunity for the scientists, patients,
the nation and the world.”
A Big Idea Without a Backer
For 25 years, Eileen K. Jaffe received federal grants to run her lab. As a
senior scientist at the Fox Chase Cancer Center, with a long list of published
papers in prestigious journals, she is a respected, established researcher.
Then Dr. Jaffe stumbled upon results that went against textbook explanations,
suggesting that it might be possible to find an entirely new class of drugs that
could disable proteins that fuel cancer cells. Now she wants to find chemicals
that might be developed into such drugs.
But her grant proposal was rejected out of hand by the institutes of health, not
even discussed by a review panel. She had no preliminary data showing that the
idea was likely to work, something reviewers always want to see, and the idea
was just too unprecedented.
Dr. Jaffe epitomizes the scientist who realizes that if she were to
single-mindedly pursue her unorthodox idea, her “career may be ruined in the
process,” in the words of Dr. Brawley of the American Cancer Society.
Dr. Jaffe is just conceiving her project; it is much to soon to know whether it
will result in a revolutionary drug. And even if she does find potential new
drugs, it is not clear that they will be effective. Most new ideas are difficult
to prove, and most potential new drugs fail.
So Dr. Jaffe was not entirely surprised when her grant application to look for
such cancer drugs was summarily rejected.
“They said I don’t have preliminary results,” she said. “Of course I don’t. I
need the grant money to get them.”
Dr. Young, chancellor at Fox Chase, said Dr. Jaffe’s situation showed why people
with bold new ideas often just give up.
“You can’t prove it will work in advance,” he said. “If you could, it wouldn’t
be a high-risk idea.”
It is a long haul, Dr. Jaffe knows. And she has already had to downsize her lab.
But, she said, she will persist.
Angels Outside Government
At the Dana-Farber Cancer Institute in Boston, Dr. Ewa T. Sicinska knew she
would have a similar problem with her research. She wanted to grow human cancers
in mice. Unlike Dr. Jaffe, though, Dr. Sicinska did not even apply for
government money.
It is not that the project was unimportant.
“Rather than have to start a human clinical trial to test new drugs, we want to
test them first in mice with real human tumors,” said Dr. George D. Demetri, who
leads the research group supporting Dr. Sicinska.
Researchers have studied mouse cancers but, they acknowledge, they are just not
the same as human cancers — they are much easier to treat, and drugs that cure
mice often do nothing in people. So, over the years, scientists have tried to
implant human cancer cells in mice, but with little success.
“Everyone told us that if you take tumors out of patients and put them in mice,
they don’t grow,” Dr. Demetri said. The tumor cells usually were put in a
plastic dish before being implanted in mice. “We said — wait a minute. The cells
are not growing in the plastic dish. They probably are dying. What if we bypass
the dish?’”
With that idea in mind, Dr. Demetri, convinced it was too speculative to get
federal money, tapped an unusual source, the Ludwig Fund. Endowed by Daniel K.
Ludwig, one of the world’s richest men in the 1960s and 1970s, the fund supports
unfettered cancer research at six medical centers in the United States,
including Dana-Farber, to be used at the institutes’ discretion. That put Dr.
Sicinska in a very different position from that of Dr. Jaffe. She could try
something chancy without a grant.
Dr. Sicinska used a quarter of a million dollars of Ludwig money for this
project, buying mice without immune systems, which meant they could not reject
human tumors, and housing them in a germ-free basement lab. She spent months
learning to implant tumors in the mice and enlisted geneticists to study the
implanted tumors, making sure they did not mutate beyond recognition.
She spends her days in the lab, using a miniature ultrasound machine to scan the
mice, hairless creatures with prominent ears. Four types of sarcomas — cancers
of fat, muscle or bone — are growing in them and look genetically identical to
the tumors removed from patients.
Dr. Elias A. Zerhouni, former director of the National Institutes of Health,
said he was not sure that a grant for the project would have been turned down.
The N.I.H., he said, does finance research on mouse models for human cancer.
But Dr. Demetri said he did not apply “because we have lots of experience in
what’s fundable.” His mouse work, he said, is exploratory, and he cannot predict
what he will find or when. He certainly could not lay out a road map of what he
would do and promise results in a few years.
Studies With a Different Goal
Researchers like Dr. Appelhans, who is studying weight control and tasty foods,
do not expect to change the outlook for cancer patients anytime soon. But, they
say, that does not mean their work is unimportant.
Dr. Appelhans will study 85 overweight or obese women, measuring how much the
tastes and textures of food drive their eating. Then they will be given a weight
loss diet and nutritional counseling. Dr. Appelhans will ask whether those who
are most tempted by the tastes and textures also have the most trouble following
the diet.
As for the grant to assess a Web-based program to improve food choices, it is
predicated on studies indicating that what people eat in childhood and
adolescence may have an impact on cancer risk in middle and old age, said the
grant recipient, Karen Weber Cullen, associate professor of pediatrics at Baylor
College of Medicine. Some studies have found that people who reported having
eaten fruits and vegetables when they were younger and maintaining a healthy
weight were less likely to have cancer.
Of course, it would not be feasible to follow participants for 30 or 40 years to
see if their cancer risk was altered, Dr. Cullen noted. But, she added, “we try
to achieve improvements in diet and physical activity behaviors that become
permanent and will make a difference in later years.”
In the study asking whether a molecular pathway that spurs the growth of colon
cancer cells also encourages the growth of breast cancer cells, the principal
investigator ultimately wants to find a safe drug to prevent breast cancer. She
received a typical-size grant of a little more than $1 million for the five-year
study.
The plan, said the investigator, Louise R. Howe, an associate research professor
at Weill Cornell Medical College, is first to confirm her hypothesis about the
pathway in breast cancer cells. But even if it is correct, the much harder
research would lie ahead because no drugs exist to block the pathway, and even
if they did, there are no assurances that they would be safe.
Dr. Howe said she hoped that she would find such drugs, or that companies would.
Then she wants to develop a way to selectively deliver the drugs to precancerous
breast cells. If it all works and the treatment is safe, women with precancerous
conditions could avoid developing cancer.
Dr. Howe has reviewed grants for the cancer institute herself, she said, and
realizes that, among other things, those that get financed must have “a novel
hypothesis that is credible based on what we know already.”
Trying to Change the System
The National Institutes of Health has started “pilot experiments” to see if
there is a better way of getting financing for innovative projects, its acting
director, Dr. Kington, said.
They include “pioneer awards,” begun in 2004 for “ideas that have the potential
for high impact but may be too novel, span too diverse a range of disciplines or
be at a stage too early to fare well in the traditional peer review process.”
But only 3 percent to 5 percent of the applicants get funded. Now the institutes
have decided to set aside up to $25 million for “transformative R01 grants,”
described as “proposing exceptionally innovative, high risk, original and/or
unconventional research with the potential to create or overturn fundamental
paradigms.”
About 700 proposals have come in, but only a small number are expected to be
financed, according to Dr. Keith R. Yamamoto, a molecular biologist and
executive vice dean of the school of medicine at the University of California,
San Francisco, and co-chairman of the committee that reviewed the proposals last
week.
“From reading the applications so far, there are really some fantastic things,”
Dr. Yamamoto said.
There also is new money from the federal economic stimulus package passed by
Congress, which gives the National Institutes of Health $200 million for
“challenge grants” lasting two years or less.
But the N.I.H. has received about 21,000 applications for 200 challenge grants,
and researchers who have applied concede there is not much hope.
“I did submit one of these challenge grants recently, like the rest of the
lemmings,” said Dr. Chi Dang, professor of medicine, cell biology, oncology and
pathology at the Johns Hopkins University School of Medicine. But, he added,
“there are many, many more applications than slots.”
Some experienced scientists have found a way to offset the problem somewhat.
They do chancy experiments by siphoning money from their grants.
“In a way, the system is encrypted,” Dr. Yamamoto said, allowing those in the
know to wink and do their own thing on the side.
Great discoveries have been made with N.I.H. financing without manipulating the
system, Dr. Klausner said.
“But,” he added, “I actually believe that by and large it is despite, rather
than because of, the review system.”
When Genae Girard received a diagnosis of breast cancer in 2006, she knew she
would be facing medical challenges and high expenses. But she did not expect to
run into patent problems.
Ms. Girard took a genetic test to see if her genes also put her at increased
risk for ovarian cancer, which might require the removal of her ovaries. The
test came back positive, so she wanted a second opinion from another test. But
there can be no second opinion. A decision by the government more than 10 years
ago allowed a single company, Myriad Genetics, to own the patent on two genes
that are closely associated with increased risk for breast cancer and ovarian
cancer, and on the testing that measures that risk.
On Tuesday, Ms. Girard, 39, who lives in the Austin, Tex., area, filed a lawsuit
against Myriad and the Patent Office, challenging the decision to grant a patent
on a gene to Myriad and companies like it. She was joined by four other cancer
patients, by professional organizations of pathologists with more than 100,000
members and by several individual pathologists and genetic researchers.
The lawsuit, believed to be the first of its kind, was organized by the American
Civil Liberties Union and filed in federal court in New York. It blends patent
law, medical science, breast cancer activism and an unusual civil liberties
argument in ways that could make it a landmark case.
Companies like Myriad, based in Salt Lake City, have argued that the patent
system promotes innovation by giving companies the temporary monopoly that
rewards their substantial investment in research and development.
Richard Marsh, Myriad’s general counsel, said company officials would not be
able to comment on the lawsuit until they had fully reviewed the complaint.
The coalition of plaintiffs argues that gene patents actually restrict the
practice of medicine and new research.
“With a sole provider, there’s mediocrity,” said Wendy K. Chung, the director of
clinical genetics at Columbia University and a plaintiff in the case.
Dr. Chung and others involved with the suit do not accuse Myriad of being a poor
steward of the information concerning the two genes at issue in the suit, known
as BRCA1 and BRCA2, but they argue that BRCA testing would improve if market
forces were allowed to work.
Harry Ostrer, director of the human genetics program at the New York University
School of Medicine and a plaintiff in the case, said that many laboratories
could perform the BRCA tests faster than Myriad, and for less money than the
more than $3,000 the company charged.
Laboratories like his, he said, could focus on the mysteries still unsolved in
gene variants. But if he tried to offer such services today, he said, he would
be risking a patent infringement lawsuit from Myriad.
Christopher A. Hansen, senior national staff counsel for the civil liberties
union, said the problem was with the patent office, not the company. He recalled
that when he first heard that the office had granted a patent for a gene, “I
said that can’t be true.”
As the A.C.L.U. explored the restrictions on competition that companies like
Myriad had put in place — blocking alternatives to the patented tests, and even
the practice of interpreting or comparing gene sequences that involved those
genes — the restrictions started to look like not just a question of patent law,
Mr. Hansen said, but of the First Amendment’s guarantee of free speech as well.
“What they have really patented,” he said, “is knowledge.”
A patent was also granted to a single company for genetic testing on long QT
syndrome, which can lead to heart arrhythmias and sudden death, and to the HFE
gene, linked to hereditary hemochromatosis, a condition in which iron
accumulates in the blood and can cause organ damage. Doctors and scientists have
complained about both patents.
On the other hand, the company that owns the patent to the gene CFTR, which has
been linked to cystic fibrosis, has licensed the testing to dozens of
laboratories, drawing praise from the medical world.
The decision to allow gene patents was controversial from the start; patents are
normally not granted for products of nature or laws of nature. The companies
successfully argued that they had done something that made the genes more than
nature’s work: they had isolated and purified the DNA, and thus had patented
something they had created — even though it corresponded to the sequence of an
actual gene.
The argument may have convinced patent examiners, but it has long been a sore
point for many scientists. “You can’t patent my DNA, any more than you can
patent my right arm, or patent my blood,” said Jan A. Nowak, president of the
Association for Molecular Pathology, a plaintiff in the case.
So far, however, two panels of government experts who have looked at the issue
have not found significant impediments to research or medical care caused by
gene patents. A 2006 report from the National Research Council found that
patented biomedical research “rarely imposes a significant burden for biomedical
researchers.”
That report and others, however, warn that the patent landscape “could become
considerably more complex and burdensome over time.”
In the future, genetic tests are likely to involve the analysis of many genes at
once, or even of a person’s full set of genes. Some 20 percent of the human
genome is already included in patent claims, amounting to thousands of
individual genes, says a draft report from the National Institutes of Health.
The report warns that “it may be difficult for any one developer to obtain all
the needed licenses” to develop the next generations of tests.
For Lisbeth Ceriani, a single mother from Newton, Mass., and a plaintiff in the
case against Myriad, the biggest obstacle that gene patents present is one of
cost. She has had breast cancer and a double mastectomy, but wants to have BRCA
testing to determine her risk of ovarian cancer and help her decide whether to
have her ovaries removed. But Myriad has refused to work with her insurance
plan, Mass Health, and paying for the test herself is beyond her means.
She is reluctant to have surgery that might prove unnecessary, she said, but she
also worries about her 8-year-old daughter and the inherited risk she might
face. Which is why, Ms. Ceriani said, she wants to “find out if I have the
mutation, so I can take the necessary steps to stay on the planet.”
“I want to be here,” she said, “to make sure she does her screening by the time
she’s 30.”
February
20, 2008
Filed at 3:02 a.m. ET
The New York Times
By THE ASSOCIATED PRESS
ATLANTA
(AP) -- U.S. cancer deaths rose by more than 5,000 in 2005, a somewhat
disappointing reversal of a two-year downward trend, the American Cancer Society
said in a report issued Wednesday.
The group counted 559,312 people who died from cancer.
The cancer death rate among the overall population continued to fall, but only
slightly, after a couple of years of more dramatic decline.
In 2005, there were just under 184 cancer deaths per 100,000 people, down from
nearly 186 the previous year. Experts said it wasn't surprising that the rate
would stabilize.
The cancer death rate has been dropping since the early 1990s, and early in this
decade was declining by about 1 percent a year. The actual number of cancer
deaths kept rising, however, because of the growing population.
So it was big news when the rate dropped by 2 percent in both 2003 and 2004,
enough to cause the total number of cancer deaths to fall for the first time
since 1930.
President Bush and others hailed that as a sign that federally funded research
was making strides against the disease.
But now the death rate decline is back to 1 percent. And the 2005 numbers show
annual cancer deaths are no longer falling, but are up more than 5,400 since
2004.
''The declining rate was no longer great enough to overcome the increase in
population,'' said Elizabeth Ward, a co-author of the cancer society report
Officials with the organization say they don't know why the decline in the death
rate eased.
It may be that cancer screenings are not having as big an effect as they were a
few years ago, said Dr. Peter Ravdin, a research professor in biostatistics at
the University of Texas M.D. Anderson Cancer Center in Houston.
One possible example: In 2004, the largest drop in deaths among the major
cancers was in colorectal cancer. Experts gave much of the credit to colonoscopy
screenings that detect polyps and allow doctors to remove them before they turn
cancerous. They also mentioned ''the Katie Couric effect'' -- a jump in
colonoscopy rates after the ''Today'' show host had the exam on national
television in 2000.
In the new report, the colorectal cancer death rate decreased by about 3 percent
from 2004 to 2005, after plunging 6 percent from 2003 to 2004.
Colorectal cancer screening rates through 2003 did not show a decline. But it's
possible they have fallen since then, Ravdin said.
Cancer society officials have also voiced concern that cancer deaths may
increase as Americans lose health insurance coverage and get fewer screenings.
The good news is the cancer death rate is still declining, and that since the
early 1990s is down more than 18 percent for men and more than 10 percent for
women. Those reductions translate to more than half a million cancer deaths
avoided, according to the cancer society.
Experts attribute the success to declines in smoking and to earlier detection
and more effective treatment of tumors.
The most significant advance in
the understanding of breast cancer for a decade was announced last night with
the identification of a new group of common genetic markers for the disease.
Scientists have discovered four
genes which, if faulty, can increase a woman's chance of developing breast
cancer - by up to 60% in the case of two of the genes. This helps explain why
women with a close relative with breast cancer are twice as likely to develop
the disease, and offers the hope of a test in the near future. The scientists
also believe the techniques used will help them unravel other cancers.
Karol Sikora, a leading cancer specialist, said of the studies published online
in Nature and Nature Genetics last night: "This set of incredible papers points
to the future understanding [of] the genetics of cancer."
It is the most significant discovery in the field since the 1990s, when
scientists identified two rare genes, BRCA1 and BRCA2, which make carriers
likely to develop breast cancer. An international coalition of researchers led
by Cancer Research UK at Cambridge University has proved the theory that
geneticists have been working on ever since: that most familial patterns of
breast cancer can be explained by myriad smaller genetic effects.
Breast cancer is twice as common in those who have a close relative who develops
it due to a fault in a gene, although the presence of a faulty gene does not
mean that cancer will definitely occur.
The scientists trawled large parts of the genome in 800 people. They identified
11,000 "tags", or blocks of DNA which point to genes, which were more common in
women with breast cancer and studied them in 8,000 more women. In the final
process, which involved 40,000 women, they narrowed the search down to five tags
which were significantly more common among women with breast cancer than those
without. The tags pointed them to four genes which they believe are responsible
for the increased breast cancer risk among the patients studied. Scientists
expect that they will find a fifth.
Two of the genes identified, FGFR2 and TNRC9, are thought to increase the risk
of breast cancer by about 20% in women who carry one faulty copy of a gene and
by between 40% and 60% in those who carry two faulty copies. The lifetime risk
for women with two faulty copies in either of these two genes would rise from
one in 11 to around one in six or seven. The other two genes increase risk by
10% if there is one fault.
A maximum 10% of breast cancers have a genetic element, and the genes scientists
know about so far account for 25% of these. The genes identified today account
for a further 4% and are responsible for only a small number of breast cancers -
up to 179 of the 44,000 diagnosed every year.
The ultimate aim is genetic screening that would band women according to risk.
But scientists warn this could create an army of "worried well". They stress
that the findings do not merit genetic testing immediately.
The findings do, however, hint at a different cause of familial breast cancers.
Three of the new genes are involved in the control of cell growth or cell
signalling, mechanisms which have never been linked to breast cancer before.
The author of the study, Douglas Easton, director of Cancer Research UK's
Genetic Epidemiology Unit in Cambridge, said: "We're very excited by these
results because the regions we identified don't contain previously known
inherited cancer genes. This opens the door to new research directions." The
techniques used are similar to those which helped identify the genes for obesity
last month.
