History > 2007 > USA > Health (V)
Illustration: Michael Bartalos
Getting to Know Your DNA
NYT
23 November 2007
http://www.nytimes.com/2007/11/23/opinion/l23dna.html
Six Killers: Lung Disease
From Smoking Boom,
a Major Killer of Women
November 29, 2007
The New York Times
By DENISE GRADY
For Jean Rommes, the crisis came five years ago, on a Monday
morning when she had planned to go to work but wound up in the hospital, barely
able to breathe. She was 59, the president of a small company in Iowa. Although
she had quit smoking a decade earlier, 30 years of cigarettes had taken their
toll.
After several days in the hospital, she was sent home tethered to an oxygen
tank, with a raft of medicines and a warning: “If I didn’t do something, life
was going to continue to be a pretty scary experience.”
Ms. Rommes has chronic obstructive pulmonary disease, or C.O.P.D., a progressive
illness that permanently damages the lungs and is usually caused by smoking.
Once thought of as an old man’s disease, this disorder has become a major killer
in women as well, the consequence of a smoking boom in the 1950s, ’60s and ’70s.
The death rate in women nearly tripled from 1980 to 2000, and since 2000, more
women than men have died or been hospitalized every year because of the disease.
“Women started smoking in what I call the Virginia Slims era, when they started
sponsoring sporting events,” said Dr. Barry J. Make, a lung specialist at
National Jewish Medical and Research Center in Denver. “It’s now just catching
up to them.”
Chronic obstructive pulmonary disease actually comprises two illnesses: one,
emphysema, destroys air sacs deep in the lungs; the other, chronic bronchitis,
causes inflammation, congestion and scarring in the airways. The disease kills
120,000 Americans a year, is the fourth leading cause of death and is expected
to be third by 2020. About 12 million Americans are known to have it, including
many who have long since quit smoking, and studies suggest that 12 million more
cases have not been diagnosed. Half the patients are under 65. The disease has
left some 900,000 working-age people too sick to work and costs $42 billion a
year in medical bills and lost productivity.
“It’s the largest uncontrolled epidemic of disease in the United States today,”
said Dr. James Crapo, a professor at the National Jewish Medical and Research
Center.
Experts consider the statistics a national disgrace. They say chronic lung
disease is misdiagnosed, neglected, improperly treated and stigmatized as
self-induced, with patients made to feel they barely deserve help, because they
smoked. The disease is mired in a bog of misconception and prejudice, doctors
say. It is commonly mistaken for asthma, especially in women, and treated with
the wrong drugs.
Although incurable, it is treatable, but many patients, and some doctors,
mistakenly think little can be done for it. As a result, patients miss out on
therapies that could help them feel better and possibly live longer. The
therapies vary, but may include drugs, exercise programs, oxygen and lung
surgery.
Incorrectly treated, many fall needlessly into a cycle of worsening illness and
disability, and wind up in the emergency room over and over again with pneumonia
and other exacerbations — breathing crises like the one that put Ms. Rommes in
the hospital — that might have been averted.
“Patients often come to me with years of being under treated,” said Dr. Byron
Thomashow, the director of the Center for Chest Disease at
NewYork-Presbyterian/Columbia hospital.
Still others are overtreated for years with steroids like prednisone, which is
meant for short-term use and if used too much can thin the bones, weaken muscles
and raise the risk of cataracts.
Adequate treatment means drugs, usually inhaled, that open the airways and quell
inflammation — preventive medicines that must be used daily, not just in
emergencies. It is essential to quit smoking.
Patients also need antibiotics to fight lung infections, vaccines to prevent flu
and pneumonia and lessons on special breathing techniques that can help them
make the most of their diminished lungs. Some need oxygen, which can help them
be more active and prolong life in severe cases. Many need dietary advice:
obesity can worsen symptoms, but some with advanced disease lose so much weight
that their muscles begin to waste. Some people with emphysema benefit from
surgery to remove diseased parts of their lungs.
Above all, patients need exercise, because shortness of breath drives many to
become inactive, and they become increasingly weak, homebound, disabled and
depressed. Many could benefit from therapy programs called pulmonary
rehabilitation, which combine exercise with education about the disease, drugs
and nutrition, but the programs are not available in all parts of the country,
and insurance coverage for them varies.
“I have a complicated, severe group of patients, but I will swear to you that
very few wind up in hospitals,” Dr. Thomashow said. “I treat aggressively. I use
the medicines, I exercise all of them. You can make a difference here. This is
an example of how we’re undertreating this entire disease.”
Little-Known Epidemic
Researchers say there is so little public awareness of how common and serious
C.O.P.D. is that the O might as well stand for “obscure” or “overlooked.”
The disease may not be well known, but people who have it are a familiar sight.
They are the ones who cannot climb half a flight of stairs without getting
winded, who have a perpetual smoker’s cough or wheeze, who need oxygen to walk
down the block or push a cart through the supermarket. Some grow too weak and
short of breath to leave the house. The flu or even a cold can put them in the
hospital. In advanced stages, the lung disease can lead to heart failure.
“This is a disease where people eventually fade away because they can no longer
cope with life,” said Grace Anne Dorney Koppel, who has chronic lung disease.
(Ms. Dorney Koppel, a lawyer, is married to Ted Koppel.) “My God, if you don’t
have breath, you don’t have anything.”
Most cases, about 85 percent, are caused by smoking, and symptoms usually start
after age 40, in people who have smoked a pack a day for 10 years or more. In
the United States, 45 million people smoke, 21 percent of adults. Only about 20
percent of smokers develop chronic lung disease.
The illness is not the same as asthma, but some patients have asthma along with
their other lung problems. Most have a combination of emphysema and chronic
bronchitis. In about one-sixth of cases, emphysema is the main problem. Women
are far more likely than men to develop chronic bronchitis, and are less prone
to emphysema. Some studies have suggested that women’s lungs are more sensitive
than men’s to the toxins in smoke.
Worldwide, these lung diseases kill 2.5 million people a year. An article in
September in The Lancet, a medical journal, said that “if every smoker in the
world were to stop smoking today, the rates of C.O.P.D. would probably continue
to increase for the next 20 years.” The reason is that although quitting slows
the disease, it can develop later.
Cigarettes are the major cause worldwide, but other sources are important in
developing countries, especially smoke from indoor fires that burn wood, coal,
straw or dung for heating and cooking. Women and children are most likely to be
exposed. Outdoor air pollution plays less of a part: it can aggravate existing
disease, but is believed to cause only 1 percent of cases in rich countries and
2 percent in poorer ones. Occupational exposures in cotton mills and mines may
contribute.
Researchers have differed about whether passive smoking plays a role, but a
Lancet article in September predicted that in China, among the 240 million
people who are now over 50, 1.9 million who never smoked will die from chronic
lung disease — just from exposure to other people’s smoke.
Many patients with lung disease have other illnesses as well, like heart
disease, acid reflux, hypertension, high cholesterol, sinus problems or
diabetes. Compared with other smokers, those with C.O.P.D. are more likely to
develop lung cancer as well. Researchers suspect that all the ailments stem
partly from the same underlying condition, widespread inflammation, a reaction
by the immune system that can affect blood vessels, organs and tissues all over
the body.
Lung disease can creep up insidiously, because human beings have lung power to
spare. Millions of airways, with enough surface area to cover a tennis court,
provide so much reserve that most people would not notice it if they lost the
use of a third or even half of a lung. But all that extra capacity can hide an
impending disaster.
“If it comes on gradually, the body can adjust,” said Dr. Neil Schachter, a lung
specialist and professor at Mount Sinai Medical Center in New York. “Some of
these patients are at oxygen levels where you and I would be gasping for
breath.”
People adjust psychologically as well, cutting back their activities, deciding
perhaps that they just do not enjoy sports anymore, that they are getting older,
gaining weight or a bit out of shape. But at some point the body can no longer
compensate, and denial does not work anymore.
“It’s like trying to breathe through a straw,” Dr. Schachter said. “It’s very
uncomfortable.”
By then, half a lung might be ruined. On a CT scan, he said, the lungs may look
“moth-eaten,” full of holes where tissue has been destroyed.
Often, the diagnosis is not made until the disease is advanced. Even though
breathing tests are easy to perform and recommended for high-risk patients like
former and current smokers, many doctors do not bother. People who do get a
diagnosis frequently are not taught how to use the inhalers that are the
mainstay of treatment. Access to pulmonary rehabilitation is limited because
Medicare has left coverage decisions to the states. Some programs have shut
down, and there are bills in the House and Senate that would require pulmonary
rehabilitation to be covered by Medicare. Medicare may also reduce coverage for
home oxygen.
Meanwhile, billions are spent on treating exacerbations, episodes of severe
breathing trouble that are often caused by colds, flu or other respiratory
infections.
A recent study of 1,600 consecutive hospitalizations for chronic lung disease in
five New York hospitals found that once patients were in the hospital, their
treatment was generally correct, Dr. Thomashow said. But “most upsetting,” he
said, was that the majority had been incorrectly treated before going to the
hospital.
For many, trying to control the disease, rather than be controlled by it, is a
daily struggle. Diane Williams Hymons, 57, a social service consultant and
therapist in Silver Spring, Md., has had lifelong problems with bronchitis,
allergies and asthma. In the last five or 10 years, her breathing difficulties
have worsened, but she was told only three years ago that she had C.O.P.D. It
motivated her to give up cigarettes, after smoking for more than 30 years.
“I have good days, and days that aren’t as great,” she said. “I sometimes have
trouble walking up steps. I have to stop and catch my breath.”
She is “usually fine” when sitting, she said.
Her mother, also a former smoker with chronic lung disease, has been in a
pulmonary rehabilitation program. Ms. Williams Hymons’s doctor has not
recommended such a program for her, but she has no idea why. They have discussed
surgery to remove part of her lungs, which helps some people with emphysema, but
she said no decision had been made yet because it is not clear whether her main
problem is emphysema or asthma. She is not sure what her prognosis is.
A Risky Approach
Ms. Williams Hymons has been taking prednisone pills for years, something both
she and her doctor know is risky. But when she tries to cut back, the disease
flares up. She has many side effects from the drug.
“My bone density is not looking real good,” she said. “I have cramps in my hands
and feet, weight gain and bloating, the moon face, excess facial hair, fat
deposits between my shoulder blades. Yes, I have those.”
She has broken two ribs just from coughing, probably because the prednisone has
thinned her bones, she said. She went to a hospital for the rib pain last year
and was given so much asthma medication to stop the coughing that it caused
abnormal heart rhythms. She wound up in the cardiac unit for five days, and now
says “never again” to being hospitalized.
Her doctor orders regular bone density tests.
“I know he’s concerned, like I’m concerned,” Ms. Williams Hymons said, “but we
can’t seem to kind of get things under control.”
A recent study of 25 primary care practices around the United States treating
chronic lung disease found that most did not perform spirometry, a simple
breathing test used to diagnose or monitor the disease, even when they had the
equipment to do so. The test takes only a few minutes, but doctors said there
was not enough time during the usual 15-minute visit. Similarly, the practices
did not offer much help with smoking cessation.
The author of the study (published in August in The American Journal of
Medicine), Pamela L. Moore, said many of the doctors felt unable to help smokers
quit, and believed that as long as patients kept smoking, treatments for lung
disease would be for nought. But Dr. Moore said research had found that people
are more likely to quit or start cutting back if doctors recommend it.
Labeling the disease self-induced is “an unbelievably painful concept,” Dr.
Thomashow said. “Patients blame themselves, their family blames them, we even
have evidence that health providers blame them.”
Shame and Blame
Indeed, a patient at a clinic in Manhattan, with nasal oxygen tubing attached to
equipment in a backpack, said, “This is one of the evils you must suffer for the
things we did in our life.”
Smoking also contributes to heart disease, Dr. Thomashow said, and yet people
“don’t waste time blaming the patient.”
“This disease quite frankly has an image problem,” said Dr. James Kiley, the
director of lung research at the National Heart, Lung and Blood Institute, which
started a campaign last January to educate people about the disease.
In one way or another every patient seems to have encountered what John Walsh,
president of the C.O.P.D. Foundation, calls the “shame and blame” attached to
this disease.
It is a familiar theme to Ms. Dorney Koppel, who agreed to become a spokeswoman
for the institute’s education campaign. She was surprised to be asked to help,
she said, because the campaign needed a celebrity, and she is merely married to
one. She asked the person who invited her, whether there were no famous people
with C.O.P.D.
“I was told, ‘None who will admit it,’” she said.
Ms. Dorney Koppel, who is candid about being a former smoker, calls the illness
the Rodney Dangerfield of diseases.
“You don’t get no respect,” she said. “I have to pay publicly for my sins. I
have paid.”
Like many patients, Ms. Rommes has both emphysema and chronic bronchitis, along
with asthma. She had symptoms for years before receiving the correct diagnosis.
She began smoking in college during the 1960s, when she was 18. People whom she
admired smoked, and it seemed cool. She smoked for 30 years.
When she quit in 1992, it was not because she thought she was ill, but because
she realized that she was organizing her day around chances to smoke. But she
almost certainly was ill. She was only 50, but climbing a flight of stairs left
her winded. From what she found in medical dictionaries, she began to suspect
she had lung disease.
By 2000 she was so short of breath that she consulted her doctor about it.
He gave her a spirometry test. In one second, healthy adults should be able to
blow out 80 percent of the total they can exhale; her score was 34 percent,
which, she knows now, indicated moderate to severe lung disease.
“I honestly don’t know whether he knew,” she said of her doctor. “I suspect he
did, but he didn’t call it emphysema.”
“He put me on a couple of inhalers and he called it asthma,” Ms. Rommes said. “I
sort of ignored the whole thing, because the inhalers did make me feel better. I
started to gain some weight, and things got progressively worse.”
She cannot help wondering now if she could have avoided becoming so desperately
ill, if she had only known sooner what a dangerous illness she had.
The turning point came in February 2003 when she tried to take a shower and
found that she could not breathe. The steam all but suffocated her. She managed
to drive from her home in Osceola, Iowa, to her doctor’s office, struggle across
the parking lot like someone climbing a mountain and collapse, gasping, onto a
couch inside the clinic. Her blood oxygen was perilously low, two-thirds of
normal, even when she was given oxygen. The hospital was next door, and her
doctor had her admitted immediately.
Fear and Anger
She had Type 2 diabetes as well as lung disease, and her doctor told her that
losing weight would help both illnesses. But she said, “He made it pretty clear
that he didn’t think I would or could.”
Motivated by fear and anger, she began riding an exercise bike, walking on a
treadmill, lifting weights at a gym and eating only 1,200 to 1,500 calories a
day, mostly lean meat with plenty of vegetables and fruit.
“I kind of came to the conclusion that if I didn’t, I probably wasn’t going to
be around,” Ms. Rommes said. “I wasn’t ready to check out. And my husband was
beginning to show the signs of Alzheimer’s disease. I knew that if I couldn’t
continue to manage our affairs, it wasn’t going to work out.”
By December 2003, her efforts were starting to pay off. She went from needing
oxygen around the clock to using it only for sleeping, and by January 2005 she
no longer needed it at all. She was able to lower the doses of her inhalers and
diabetes medicines. By February 2005, she had lost 100 pounds.
The daily exercise also helped her deal with the stress of her husband’s
illness. He died in June.
“I had no clue that exercise would do as much for ability to breathe as it did,”
she said, adding that it helped more than the drugs, which she described as
“really pretty minimal.”
She is hooked on exercise now, getting up every morning at 5 a.m. to walk for 45
minutes on the treadmill. She goes at it hard enough to break a sweat, wearing a
blood oxygen monitor to make sure her level does not dip too low (if it does,
she slows down or uses special breathing techniques to bring it up). She walks
outdoors, as well, and three times a week, she works out with weights at a gym.
“Exercise is absolutely essential, and it’s essential to start it as soon as you
know you have C.O.P.D.,” she said.
Exercise does not heal or strengthen the lungs themselves, but it improves
overall fitness, which people with lung disease need desperately because their
shortness of breath leads to inactivity, muscle wasting and loss of stamina.
“Both my pulmonologist and my regular doctor have made it really, really clear
to me that I have not increased my lung capacity at all,” Ms. Rommes said. “But
I’ve improved the mechanics. I’ve done everything I know how to do to make the
lung capacity as efficient as possible. That’s the key for me; I know there are
lots of people with this disease who don’t exercise, who I guess just give up.”
She realizes that she has two serious chronic diseases that could shorten her
life. But it does not worry her much, she said, because she figures she is doing
everything she can to take care of herself, and would rather spend her time
enjoying life — work, reading, opera, traveling, children and grandchildren.
“I will tell pretty much anybody that I have emphysema,” Ms. Rommes said. “They
say, ‘Did you smoke?’ I say, ‘Yes I did, for 30 years, and I quit in 1992.’
Maybe it’s why I’ve attacked this the way I did. O.K., I did it to myself, and
so I better do everything I can to get out of it. We all do things in our lives
that are stupid, and then you do what you can to fix it.”
From Smoking Boom, a
Major Killer of Women, NYT, 29.11.2007,
http://www.nytimes.com/2007/11/29/health/29lung.html
States Slow
to Ban Restaurant Trans Fats
November 27, 2007
Filed at 7:52 p.m. ET
By THE ASSOCIATED PRESS
The New York Times
COLUMBUS, Ohio (AP) -- States from Connecticut to California
have looked this year to mimic the success of large cities like New York in
banning artery-clogging trans fats from restaurants.
But in the 14 states that have so far proposed a ban or restriction, not a
single bill has been passed as the year draws to a close. This month, Ohio
became the 15th state to make such a proposal.
New bills often take time to wind their way through committees and come up for a
vote. But the legislation has also faced strong opposition from the National
Restaurant Association and its state-level affiliates -- although the
Massachusetts' group recently said it wouldn't fight that state's bill.
The national association says it doesn't oppose phasing out trans fats but
objects to what it calls ''inflexible bans with unrealistic timetables.''
''It's not as easy as just dumping in a new oil,'' said Sheila Weiss, director
of nutrition policy for the group.
A voluntary, gradual approach would ''significantly diminish the impact and
unintended consequences of an outright ban,'' Richard Mason, lobbyist for the
Ohio Restaurant Association, wrote in a letter to Ohio's trans fat bill sponsor.
The industry points to the voluntary no-trans-fat movements at fast-food
restaurants such as Wendy's, KFC and Taco Bell to emphasize to lawmakers that
there's no need to get government involved. A ban could force restaurants to
switch to saturated fats -- which also contribute to heart disease -- if they
haven't had time to find a healthier alternative, the industry says.
But proponents of the bills said it's relatively easy to switch to other oils
such as canola or corn oil, pointing to New York City, where restaurants have
complied with the ban's first phase -- which applies to oils, shortening and
margarine used for frying and spreading -- without much fanfare.
Sylvia's, a soul food restaurant in Manhattan, said it switched to frying
without trans fat oil before the city's ban went into effect in July. The
transition was easy except for a few desserts, said restaurant marketing
director Trenness Woods-Black.
''We switched and no one noticed the difference. We still have super crispy
fried chicken,'' she said.
But some bakeries around the country have said it's hard to make baked goods
with the same quality without trans fats. The main source of trans fat is
partially hydrogenated oils, created when hydrogen is added to liquid cooking
oils to harden them for baking or for a longer shelf life.
The Philadelphia City Council approved a bill to exempt bakeries from that
city's ban after many bakeries complained.
Critics say the restaurant group's argument is undercut by the success
restaurants have had getting rid of trans fats.
''The restaurant association has a very strong lobbying effort and they've made
a major effort to keep this from getting passed,'' said Julie Greenstein, deputy
director for health promotion policy at the Center for Science in the Public
Interest in Washington. In many cases, the center has been the driving force
behind trans fat bills.
A New York Democratic legislator, Felix Ortiz, has been trying since 2004 to get
a trans fat restriction into state law. But the restaurant industry has
cultivated members on key committees, Ortiz said. His latest bill focuses on
chain restaurants.
''We are going to get it done,'' said Ortiz, who pushed through New York's ban
on talking on a cell phone while driving.
The other states that have proposed a ban or restriction on trans fats in
restaurants are Maryland, Michigan, Illinois, New Jersey, New Hampshire, Rhode
Island, South Carolina, Tennessee, Vermont and Hawaii.
------
On the Net:
http://www.restaurant.org
http://www.cspinet.org
States Slow to Ban
Restaurant Trans Fats, NYT, 28.11.2007,
http://www.nytimes.com/aponline/us/AP-Diet-Trans-Fat-States.html
Felix Sockwell
Health Care: A National Conversation
NYT 28.11.2007
http://www.nytimes.com/2007/11/28/opinion/lweb28health.html
Letters
Health Care: A National Conversation
November 28, 2007
The New York Times
To the Editor:
“The High Cost of Health Care”
(editorial, Nov. 25) captures the true complexities facing the challenges of the
American health care system.
Those who truly immerse themselves in the issues of health care are well aware
that indeed reform is not near, nor will it ever be achieved until there is a
fundamental compromise on all the matters outlined.
The greatest obstacle to achieving universal health care will come from those
who choose to avoid these fundamental issues while guided only by their
political ambitions.
Reno DiScala, M.D.
Glen Cove, N.Y., Nov. 25, 2007
•
To the Editor:
Your otherwise thoughtful editorial about the health care crisis facing the
United States curiously dismisses the idea of a single-payer health care plan as
“no panacea” for the cost problem and as having “limited political support.”
But the question isn’t whether a single-payer plan is a panacea — it is whether
a single-payer plan would significantly reduce costs compared with
insurance-based plans, and the answer is a decided yes.
The administrative costs of Medicare are approximately 20 percent of the
administrative costs of private insurance plans, and all of those administrative
savings in a comprehensive Medicare-for-all system could be poured into more and
better health care.
As to whether a single-payer plan has political support, it depends on whether
you ask the average person or the average politician. Whereas polls show that a
majority of the people favor a single-payer plan, the politicians, many of whom
are beholden to the insurance industry, would like you to believe otherwise.
Instead of wringing your hands about the supposed unworkability and unpopularity
of a single-payer plan (even in the face of the highly successful and popular
Medicare, with a 40-year track record), The Times should put its considerable
influence behind the only real solution to the health care crisis: Medicare for
all.
Peter Hanauer
Berkeley, Calif., Nov. 25, 2007
•
To the Editor:
A single-payer, government-run system was only briefly mentioned and was
immediately dismissed as “no panacea for the cost problem.” The truth is that
single-payer, government-run health care has been a panacea.
In the 46 years that I’ve practiced family medicine, I’ve found Medicare,
Medicaid, the Veterans Administration, all of them single-payer
government-administered health care programs, more predictable, uniform and
reliable than the for-profit health care insurance companies. This is better for
doctors and hospitals and certainly better for the patients.
I like one form to file, one payer, one set of rules for everyone and the
assurance that everyone has health care coverage when patients come to see me.
Melvin H. Kirschner, M.D.
Van Nuys, Calif., Nov. 25, 2007
•
To the Editor:
With regard to “The High Cost of Health Care,” the amount we spend on health
care, while troubling, should not be the main issue in the great health care
debate. The focus should be on two things: one, the 47 million uninsured who
cannot regularly participate in the health care system (not all of which is due
to the high cost); and two, the poor state of our nation’s health in comparison
to other countries that spend far less in this area.
Many of our citizens do not have good health, despite the expensive technology,
drugs and specialists indicative of our health care system. Our infant mortality
rate remains high in comparison to other nations, and older adults live many
years with chronic illness and disability.
We can expect many of our health status indicators to get worse, not better, in
the coming decades as our uninsured population grows, our minority and immigrant
populations grow, and as baby boomers age.
These demographic influences are the rationale for the Healthy People 2010 goals
of reducing racial and ethnic health disparities and extending years of healthy
life. We are the richest nation. First, let’s allocate our economic, medical and
research resources to provide good health to every American; then we can figure
out how to do it cost-effectively.
Jan Warren-Findlow
Charlotte, N.C., Nov. 25, 2007
The writer is an assistant professor of public health sciences, University of
North Carolina at Charlotte.
•
To the Editor:
The Times is right to call health care costs “the worst long-term fiscal crisis
facing the nation.”
Although universal coverage could be cheaper to finance and easier to
administer, few concur on how to preserve consumer choice or how to persuade the
uninsured to buy into the system.
Here’s how:
Extend Medicare coverage to all, financed by an increase in the withholding tax
and elimination of the tax subsidies for employee health insurance. Those
willing to settle on a Canadian-style system can have one, but those wanting to
opt out could receive a tax credit to buy alternative or supplemental policies
offered by the private market.
Insurers would be required to accept all applicants and offer community rates,
with the government underwriting catastrophic costs above a defined level.
The Medicare withholding tax could be progressively structured and the credit
capped to provide fairness.
Allan Ostergren
Director, Institute for SocioEconomic Studies
White Plains, Nov. 26, 2007
•
To the Editor:
I would certainly not agree with “almost all economists” that “the main driver
of high medical spending here is our wealth.” The per capita income of Americans
is less than that of several European countries, and certainly not enough to
explain our spending twice as much per capita on health care.
Where we are unique is in leaving most of our health system to the tender
mercies of profit-maximizing investor-owned businesses.
You are right that Medicare-for-all “is no panacea for the cost problem.” As now
structured, Medicare pays specialists extravagant fees to perform tests and
procedures, which drives up costs. But it could easily be reformed. In any case,
some sort of single-payer system will be necessary to control costs, even if not
sufficient.
Marcia Angell, M.D.
Cambridge, Mass., Nov. 25, 2007
The writer is a senior lecturer in social medicine at Harvard Medical School and
a former editor in chief of The New England Journal of Medicine.
•
To the Editor:
Have any of us ever recommended a physician based on his or her prudent
allotment of health care dollars? The cardiologist who forgoes cardiac
catheterization in your elderly grandmother because her short life expectancy
doesn’t justify the expense? The neonatologist who declines to aggressively
resuscitate your premature newborn because its tiny chance of intact survival
doesn’t justify the astronomical cost of months of neonatal intensive care? The
emergency medicine doctor who refuses to med-flight your teenager after a deadly
car crash because he isn’t going to make it anyway?
It’s easy to blame doctors for spending lavishly on their patients. But it is
simply hypocritical for patients to criticize the spendthrift culture of
American medicine while continuing to demand any intervention available despite
its high cost and/or low likelihood of benefit.
There’s no such thing as a free lunch.
Joshua U. Klein, M.D.
Brookline, Mass., Nov. 25, 2007
•
To the Editor:
Several states are already pursuing their own health care payment programs. The
federal government should not develop a one-size-fits-all national program but
rather encourage all of the states to develop programs. Placing the
responsibility for financing and administering the program at the state level
would preserve the disparities in expenditures on health care from one region to
another; it would foster experimentation and competition among states to develop
and carry out cost-saving strategies.
As the state programs prove themselves, even Medicare might be delegated to
them.
John A. Rowland
Rocky River, Ohio, Nov. 26, 2007
•
To the Editor:
With malpractice insurance approaching $100,000 a year for many health care
providers, litigation plays more than a “minor role” in driving up costs. How
often do physicians recommend additional treatments just to avoid a potential
lawsuit?
Does the legal environment diminish the availability of quality health care by
reducing the supply and increasing the cost? How many patients are put at
increased risk, and forced to pay higher costs, simply because of a hostile
attitude toward the medical profession by often-greedy lawyers?
Malpractice occasionally occurs, and there should be remedies for those who are
harmed. But there’s an army of litigators out there who are eager to generate
income at the expense of the system. Why else would so many trial lawyers make
substantial contributions to politicians who are willing to ignore any
possibility of medical liability reform?
Health care costs cannot be contained without addressing the legal issues.
William L. Burge
Ballwin, Mo., Nov. 25, 2007
•
To the Editor:
Missing from the editorial was the problems we face in end-of-life care and its
effect on all of medicine. Although hospice use has increased, so has the number
of people dying in intensive care units. Thousands, perhaps hundreds of
thousands, of nursing home patients each year are transferred to hospitals for
acute care from which they can derive no benefit because of that person’s
underlying health.
This type of care is more prevalent in our large teaching hospitals, training
young doctors that inappropriate, expensive care is the norm, which has
contributed to the widespread excessive use of procedures and drugs.
It takes judgment to determine what is suitable for each individual’s unique
health situation. Any solution to our health care problem must emphasize
appropriate care tailored to the individual needs of every patient.
Kenneth A. Fisher, M.D.
Kalamazoo, Mich., Nov. 26, 2007
Health Care: A National
Conversation, NYT, 28.11.2007,
http://www.nytimes.com/2007/11/28/opinion/lweb28health.html
Editorial
The High Cost of Health Care
November 25, 2007
The New York Times
The relentless, decades-long rise in the cost of health care has left many
Americans struggling to pay their medical bills. Workers complain that they
cannot afford high premiums for health insurance. Patients forgo recommended
care rather than pay the out-of-pocket costs. Employers are cutting back or
eliminating health benefits, forcing millions more people into the ranks of the
uninsured. And state and federal governments strain to meet the expanding costs
of public programs like Medicaid and Medicare.
Health care costs are far higher in the United States than in any other advanced
nation, whether measured in total dollars spent, as a percentage of the economy,
or on a per capita basis. And health costs here have been rising significantly
faster than the overall economy or personal incomes for more than 40 years, a
trend that cannot continue forever.
It is the worst long-term fiscal crisis facing the nation, and it demands a
solution, but finding one will not be easy or palatable.
The Causes
Varied and Deep-Rooted. Contrary to popular beliefs, this is not a problem
driven mainly by the aging of the baby boom generation, or the high cost of
prescription drugs, or medical malpractice litigation that spawns defensive
medicine. Those issues often dominate political discourse, but they have played
relatively minor roles in driving up medical spending in this country and
abroad. The major causes are much more deep-seated and far harder to root out.
Almost all economists would agree that the main driver of high medical spending
here is our wealth. We are richer than other countries and so willing to spend
more. But authoritative analyses have found that we spend well above what mere
wealth would predict.
This is mostly because we pay hospitals and doctors more than most other
countries do. We rely more on costly specialists, who overuse advanced
technologies, like CT scans and M.R.I. machines, and who resort to costly
surgical or medical procedures a lot more than doctors in other countries do.
Perverse insurance incentives entice doctors and patients to use expensive
medical services more than is warranted. And our fragmented array of insurers
and providers eats up a lot of money in administrative costs, marketing expenses
and profits that do not afflict government-run systems abroad.
Does It Matter? If citizens of an extremely wealthy nation like the United
States want to spend more on health care and less on a third car, a new computer
or a vacation home, what’s wrong with that? By some measures, Americans are
getting good value. Studies by reputable economists have concluded that spending
on such advanced treatments as cardiac drugs, devices and surgery; neonatal care
for low-birth-weight infants; and mental health drugs have more than paid for
themselves by extending lives and improving their quality.
But if health care spending continues on its same trajectory, the United States
will reach the point — probably several decades from now — where every penny of
the annual increase in gross domestic product would have to go for health care.
There would be less and less money for other things, like education,
environmental protection, scientific research and national security, that may be
equally or more important to the well-being of society.
Governmental budgets will face the crisis even sooner. States are already
complaining that they have to crimp other vital activities, like education, to
meet soaring Medicaid costs. And federal spending on Medicare and Medicaid is
surging upward at rates that will cause the deficit to soar. That means
politicians will have to raise taxes, severely cut a wide range of other
governmental programs, or chop back the health programs themselves.
The question is: What can be done to lower both the high level of health care
spending and its high rate of increase from year to year?
The Solutions
Geography. Pioneering studies by researchers at Dartmouth have shown enormous
disparities in expenditures on health care from one region to another with no
discernible difference in health outcomes. Doctors in high-cost areas use
hospitals, costly technology and platoons of consulting physicians a lot more
often than doctors in low-cost areas, yet their patients, on average, fare no
better. There are hints that they may even do worse because they pick up
infections in the hospital and because having a horde of doctors can mean no one
is in charge.
If the entire nation could bring its costs down to match the lower-spending
regions, the country could cut perhaps 20 to 30 percent off its health care
bill, a tremendous saving. That would require changing the long- ingrained
practices of the medical profession. Public and private insurers might need to
refuse coverage for high-cost care that adds little value.
Stick to What Works. The sad truth is that less than half of all medical care in
the United States is supported by good evidence that it works, according to
estimates cited by the Congressional Budget Office. If doctors had better
information on which treatments work best for which patients, and whether the
benefits were commensurate with the costs, needless treatment could be junked,
the savings could be substantial, and patient care would surely improve. It
could take a decade, or several, to conduct comparative-effectiveness studies,
modify relevant laws, and change doctors’ behavior.
Managed Care. For a brief period in the 1990s it looked as if health maintenance
organizations competing for patients and carefully managing their care might
bring down costs and improve quality at the same time. The H.M.O.’s did help
restrain costs for a few years. The problem was, doctors and patients hated the
system, management became much looser, and the upsurge in costs resumed. Managed
care techniques are creeping back into some health plans, especially for
services apt to be overused, but too heavy a hand would most likely produce
another backlash.
Information Technologies. The American health care system lags well behind other
sectors of the economy — and behind foreign medical systems — in adopting
computers, electronic health records and information-sharing technologies that
can greatly boost productivity. There is little doubt that widespread
computerization could greatly reduce the paperwork burden on doctors and
hospitals, head off medication errors, and reduce the costly repetition of
diagnostic tests as patients move from one doctor to another. Without an
infusion of capital, the transition from paper records is not apt to happen very
quickly.
Prevention. Everyone seems to be hoping that preventive medicine — like weight
control, exercise, better nutrition, smoking cessation, regular checkups,
aggressive screening and judicious use of drugs to reduce risks — will not only
improve health but also lower costs in the long run. Preventive medicine
actually costs money — somebody has to spend time counseling patients and
screening them for disease — and it is not clear how soon, or even whether,
substantial savings will show up. Still, the effort has to be made. The Milken
Institute recently estimated that the most common chronic diseases cost the
economy more than $1 trillion annually, mostly from lost worker productivity,
which could balloon to nearly $6 trillion by the middle of the century.
Disease Management. Virtually all policy experts want more careful coordination
of the care of chronically ill patients, who account for the largest portion of
the nation’s health care expenditures. Although that should improve the quality
of the care they get, coordination may not cut costs as substantially as people
expect. In some initial trials it has cut costs, in others not.
Drug Prices. Compared with the residents of other countries, Americans pay much
more for brand-name prescription drugs, less for generic and over-the-counter
drugs, and roughly the same prices for biologics. This page believes it would be
beneficial to allow Medicare to negotiate with manufacturers for lower
prescription drug prices and to allow cheaper drugs to be imported from abroad.
The prospect for big savings is dubious.
Who Picks Up the Tab?
Pay Providers Less. With doctors dreadfully unhappy under the heavy hand of
insurers, it would seem shortsighted to make them even unhappier by cutting
their compensation to levels paid in other countries. But many experts believe
it should be possible to tap into the vast flow of money sluicing through
hospitals, nursing homes and other health care facilities to find savings.
Emphasize Primary Care. In a health system as uncoordinated as ours, many
experts believe we could get better health results, possibly for less cost, if
we changed reimbursement formulas and medical education programs to reward and
produce more primary care doctors and fewer specialists inclined to proliferate
high-cost services. It would be a long-term project.
Skin in the Game. The solution favored by many conservatives is to force
consumers to shell out more money when they seek medical care so that they will
think harder about whether it is really necessary. The “consumer-directed health
care” movement calls for providing people with enough information about doctors
and treatments so that they can make wise decisions.
There would most likely be some savings. A classic experiment by Rand
researchers from 1974 to 1982 found that people who had to pay almost all of
their own medical bills spent 30 percent less on health care than those whose
insurance covered all their costs, with little or no difference in health
outcomes. The one exception was low-income people in poor health, who went
without care they needed. Any cost-sharing scheme would have to protect those
unable to bear the burden.
And consumer-driven plans have limitations. Most health care spending is racked
up by a small percentage of individuals whose bills are so high they are no
longer subject to cost sharing; they will hardly be deterred from expensive care
they desperately need. Moreover, few consumers have the competence or knowledge
to second-guess a doctor’s recommendations.
Single Payer. Deep in their hearts, many liberals yearn for a single-payer
system, sometimes called Medicare-for-all, that would have the federal
government pay for all care and dictate prices. Such a system would let the
government offset the price-setting strength of the medical and pharmaceutical
industries, eliminate much of the waste due to a multiplicity of private
insurance plans, and greatly cut administrative costs.
But a single-payer system is no panacea for the cost problem — witness
Medicare’s own cost troubles — and the approach has limited political support.
Private insurers could presumably eliminate some of the waste through uniform
billing and payment procedures.
•
By now it should be clear that there is no silver bullet to restrain soaring
health care costs. A wide range of contributing factors needs to be tackled
simultaneously, with no guarantee they will have a substantial impact any time
soon. In many cases we do not have enough solid information to know how to cut
costs without impairing quality. So we need to get cracking on a range of
solutions. The cascade of knowledge flowing from the human genome project, new
nanotechnologies and the advent of treatments tailor-made for individual
patients may well accelerate, not mitigate, the rise in medical spending. If we
want the benefits, we will need to make them affordable.
The High Cost of Health
Care, NYT, 25.11.2007,
http://www.nytimes.com/2007/11/25/opinion/25sun1.html
Letters
Getting
to Know Your DNA
November
23, 2007
The New York Times
To the
Editor:
Re “My Genome, Myself: Seeking Clues in DNA” (“The DNA Age” series, front page,
Nov. 17):
Wanting to know more about ourselves is both a strength and a hazard. The lure
of genetic data can be compelling but misleading, for no list of tiny variants
in one’s genetic code can reliably predict one’s future regarding cancer, heart
attacks or diabetes, let alone I.Q., addiction or gullibility.
Amy Harmon’s humorous account of her own genome search may still leave many
readers willing to send off a little saliva — and a big check — to a genome
company. Those companies are selling only a fragment of your identity. Knowing
that you have this or that disease-associated SNP in your genes tells you very
little or helps only with rare diseases.
What causes the SNP (single nucleotide polymorphism) to be expressed, to spring
into action or to remain dormant? Why can identical twins, with genomes alike
down to the last SNP, develop different diseases? What if you smoke, toil for
years in a high-stress job or live in a polluted neighborhood?
Predispositions are just the beginning. Your future depends on much more than
your genetic code. Ms. Harmon would have done better to spend her money on a
good gym, and The Times would serve us better by emphasizing the limits of
genetic knowledge.
Susan M. Reverby, Ph.D.
Jay Kaufman, Ph.D.
H. Jack Geiger, M.D.
Cambridge, Mass., Nov. 18, 2007
Dr. Reverby is professor of the history of ideas at Wellesley College; Dr.
Kaufman is associate professor of epidemiology at the University of North
Carolina, Chapel Hill; and Dr. Geiger is emeritus professor of community
medicine at City University of New York Medical School.
•
To the Editor:
The exposé on surfing for one’s genome demonstrates the slipperiness of tapping
genetic information. Personally, I’d rather not know about my predilection for
certain tastes mainly because it would take the fun out of trying new foods.
(Not the cream of lobster: I’m lactose-intolerant and lack the taste gene for
bottom-feeding sea creatures!!)
Yet I recognize the importance of genetic research in biology and medicine. The
paradox is that to make intellectual strides, society must accept some risk.
People should recognize that a wealth of both critical and inconsequential
genetic information is becoming available. But within privacy laws, they should
also be able to keep the right to choose the movies they watch, the Web sites
they frequent and how much they want to learn about their genetic potential.
Andrew Zinn, M.D.
Kew Gardens, Queens, Nov. 17, 2007
•
To the Editor:
Amy Harmon mentions the risk that insurers might deny coverage based on future
availability of a person’s detailed genetic information. The future also poses a
risk that employers could misuse genetic screening and data.
Since 1990, most states have passed laws to prevent genetic discrimination, but
federal protection is essential. The Genetic Information Nondiscrimination Act
of 2007 was passed by the House this spring; Senator Olympia Snowe, Republican
of Maine, has proposed a Senate version. If you are worried about such
discrimination (and you should be), contact your senators to voice your support
of this legislation.
Katherine Brokaw
Atlanta, Nov. 17, 2007
•
To the Editor:
The real news is that the genetic genie is out of the bottle. The consumer’s
embrace of genetic analysis is now unstoppable. And though the medical community
warns how little we can actually learn from most of our genes, these caveats do
not diminish our curiosity.
The truth is that the medical establishment has not co-opted the genetic
paradigm because doctors are busy and see little value right now for themselves
or their patients. As such, genetics may go the way of cosmetic dermatology and
surgery.
Hugh Young Rienhoff Jr., M.D.
San Francisco, Nov. 18, 2007
The writer is director of MyDaughtersDNA.org., a forum on genetics.
Getting to Know Your DNA, NYT, 23.11.2007,
http://www.nytimes.com/2007/11/23/opinion/l23dna.html
Analysis: Hurdles Remain for Stem Cells
November
22, 2007
Filed at 12:51 a.m. ET
By THE ASSOCIATED PRESS
The New York Times
NEW YORK
(AP) -- For all the excitement, big questions remain about how to turn this
week's stem cell breakthrough into new treatments for the sick. And it's not
clear when they'll be answered.
Scientists have to learn more about the new kind of cell the landmark research
produced. They have to find a different way to make it, to avoid a risk of
cancer. And even after that, there are plenty of steps needed to harness this
laboratory advance for therapy.
So if you ask when doctors and patients will see new treatments, scientists can
only hedge.
''I just can't tell you dates,'' says James Thomson of the University of
Wisconsin-Madison, one of the scientists in the U.S. and Japan who announced the
breakthrough on Tuesday.
''The short answer is: It's still going to be years,'' Dr. John Gearhart, a stem
cell expert at the Johns Hopkins School of Medicine who was familiar with the
work, said Wednesday.
Such a delay isn't unusual. It can often take a long time for medical payoffs to
flow from basic scientific findings.
For example, the inspiration for a group of cystic fibrosis drugs now being
tested in people or animals goes back 18 years to a genetic discovery. And more
generally, gene therapy -- the notion of fixing or replacing defective genes --
has been studied in people for more than 15 years without much success.
At least, federal money for research into the new kind of cell won't be a
problem, said Story Landis, head of the National Institutes of Health's Stem
Cell Task Force. The task force is about to invite scientists to apply for new
grants for such work, she said.
This week's advance has apparently solved a supply problem for the study of
embryonic stem cells. These cells are valued for their ability to morph into any
of the cell types of the body. Scientists had long searched for a way to produce
embryonic cells that carry the genes of a particular person.
Such cells could be used for at least three purposes. The most highly publicized
one is to create transplant tissue for treating disease. In the shorter term,
they could be used to create ''diseases in a dish,'' colonies of cells bearing
illness-promoting genes that could reveal the vulnerable roots of medical
conditions. And finally, scientists could use such cells for rapidly screening
potential medicines in the laboratory.
Until this week's announcement, scientists who wanted to make such cells looked
to an expensive, cumbersome cloning process that destroyed embryos, making it an
ethical lightning rod. And it hadn't yet worked with human embryos.
The new technique is much simpler. It makes human skin cells behave like
embryonic stem cells without using embryos at all.
End of problem? Not unless these altered skin cells can truly replace embryonic
cells, and that's not clear yet, a prominent scientist says.
Paul Berg, a Stanford University Nobel laureate who helped establish federal
guidelines for human research on genetically manipulated cells, said the
celebration over this week's announcement is premature.
''I'm amazed at the ethicists'' saying the problem of needing embryos has been
solved, Berg said. ''We're not in the clear -- this is a first step.''
So what are the next steps?
The first basic question to solve is how similar iPS cells are in behavior and
potential to the embryonic cells that scientists have studied for nearly a
decade.
''My guess is that we'll find that there are significant differences,'' said Dr.
Robert Lanza of Advanced Cell Technology, which has been trying to produce stem
cells from cloned human embryos. ''I'd be surprised if these cells can do all
the same tricks as well as stem cells derived from embryos.''
Another big question is how to make iPS cells in a different way. The
breakthrough technique treats skin cells by using viruses to carry in a quartet
of genes. Those viruses disrupt the DNA of the skin cells. When that happens,
there's a risk of cancer.
That's show-stopper when it comes to creating tissue to transplant into people.
So scientists have to figure out a way to make iPS cells without those
DNA-disrupting viruses.
Scientists should be able to find other ways to slip the genes into the skin
cells, Thomson said. Other scientists suggest that a purely chemical treatment,
not inserting genes at all, might be able to get the same result.
The cancer-risk problem should be solved quickly, maybe within a year or so,
said Doug Melton, co-director of the Harvard Stem Cell Institute.
Before then, iPS cells could be used in lab studies to study the early roots of
genetic disease or to screen drugs. But of course, it's anybody's guess when a
useful treatment would result from that.
Even with the cancer problem solved for transplant uses, there's another big
hurdle:
The whole idea of using embryonic stem cells or iPS cells for treating people
with conditions like diabetes and Parkinson's disease via transplant is itself
far from proven. Scientists will need to learn how to turn iPS cells into the
right kind of tissue, and how to use that tissue in a way that will treat a
person's disease.
Such studies, in the lab, animals and finally people, will take years.
As far as that obstacle goes, Thomson said, the breakthrough announced this week
changes nothing.
''We have a lot of work to do.''
------
AP Medical Writer Marilynn Marchione contributed to this story from Milwaukee.
Analysis: Hurdles Remain for Stem Cells, NYT, 22.11.2007,
http://www.nytimes.com/aponline/us/AP-Stem-Cells.html
Man Who
Helped Start Stem Cell War May End It
November
22, 2007
The New York Times
By GINA KOLATA
If the stem
cell wars are indeed nearly over, no one will savor the peace more than James A.
Thomson.
Dr. Thomson’s laboratory at the University of Wisconsin was one of two that in
1998 plucked stem cells from human embryos for the first time, destroying the
embryos in the process and touching off a divisive national debate.
And on Tuesday, his laboratory was one of two that reported a new way to turn
ordinary human skin cells into what appear to be embryonic stem cells without
ever using a human embryo.
The fact is, Dr. Thomson said in an interview, he had ethical concerns about
embryonic research from the outset, even though he knew that such research
offered insights into human development and the potential for powerful new
treatments for disease.
“If human embryonic stem cell research does not make you at least a little bit
uncomfortable, you have not thought about it enough,” he said. “I thought long
and hard about whether I would do it.”
He decided in the end to go ahead, reasoning that the work was important and
that he was using embryos from fertility clinics that would have been destroyed
otherwise. The couples whose sperm and eggs were used to create the embryos had
said they no longer wanted them. Nonetheless, Dr. Thomson said, announcing that
he had obtained human embryonic stem cells was “scary,” adding, “It was not
known how it would be received.”
But he never anticipated the extent and rancor of the stem cell debate. For
nearly a decade now, the issue has bitterly divided patients and politicians,
religious groups and researchers.
Now with the new technique, which involves adding just four genes to ordinary
adult skin cells, it will not be long, he says, before the stem cell wars are a
distant memory. “A decade from now, this will be just a funny historical
footnote,” Dr. Thomson said in the interview.
As for the science behind it, the thrill of discovery, he said, “Surprisingly,
there is no ‘Wow’ moment,” either from 1998 or now. Both times, the discovery
came after he had spent months rigorously testing the cells to be sure they
really were stem cells, worrying all the while that they could die or be lost to
contamination. When he knew he had succeeded, the suspense was gone.
“Imagine holding your breath for a few months,” Dr. Thomson said. When he was
done, he said, “I felt mostly a sense of relief.”
But he knows what he wrought. Stem cells, universal cells that can turn into any
of the body’s 220 cell types, normally emerge only fleetingly after a few days
of embryo development. Scientists want to use them to study complex human
diseases like Alzheimer’s or Parkinson’s in a petri dish, finding causes and
treatments. And, they say, it may be possible to use the cells to grow
replacement tissues for patients.
The problem until now had been the source of the cells — human embryos.
The topic, says R. Alta Charo, a University of Wisconsin ethicist, “took on an
almost iconic quality the same way Roe v. Wade has.”
In the meantime, many leading scientists decided not to get into the stem cell
field. There was a stigma attached, Dr. Thomson says. And, he adds, “Most
scientists don’t like controversial things.”
A native of Oak Park, Ill., James Alexander Thomson, 48, did not set out to
throw bioethical bombs. All he wanted, he said, was to answer the most basic
scientific questions about cellular development.
First there was a degree in biophysics from the University of Illinois. As a
graduate student, Dr. Thomson began working with mouse embryonic stem cells and
then, with federal support, he extracted stem cells from monkey embryos. After
earning two doctorates from the University of Pennsylvania, one in veterinary
medicine and one in molecular biology, he continued research at his own
laboratory at the University of Wisconsin.
Eventually he realized, though, that studying mice and monkeys could take him
only so far. If he wanted to understand how human embryos develop and why their
development sometimes goes awry, he needed human stem cells. But, he says, he
hesitated.
In 1995, he began consulting with two ethicists at his university, Dr. Norman
Fost, a physician, and Ms. Charo, a law professor. He wanted to anticipate what
the ethical problems might be and what the criticisms might be.
Dr. Fost was impressed.
“It is unusual in the history of science for a scientist to really want to think
carefully about the ethical implications of his work before he sets out to do
it,” Dr. Fost said. “The biggest problem in ethics is not anticipating
problems.”
But Dr. Fost and Dr. Thomson guessed wrong about what would bother people most.
They thought it would be what Dr. Fost termed “the technological power” of stem
cells. What if someone put human stem cells into the brain of a rat, for
example?
“I thought at the time that this was possibly the biggest issue,” Dr. Fost said.
“It was unprecedented in the history of biology. It’s the ‘Help, get me out of
here’ scenario. Let’s say the rat brain turns out to be entirely human cells.
What’s going on in there? Is it a human brain? And how would you study it — you
can’t ask the rat.”
Meanwhile, as Dr. Thomson was planning his effort to obtain human embryonic stem
cells, another discovery changed his entire view of development. In 1997, Ian
Wilmut, a scientist in Scotland, announced the creation of the first cloned
mammal, Dolly, cloned from frozen udder cells from a long-dead sheep.
Dr. Wilmut had slipped an udder cell — a cell that normally would never be
anything but an udder cell — into an egg whose genetic material had been
removed. The egg somehow brought the udder cell’s chromosomes back to the state
they had been in when embryo development first began.
“Dolly changed the way I thought about developmental biology,” Dr. Thomson says.
“Development was reversible.”
Four years ago he and, independently, Shinya Yamanaka of Kyoto University set
out to figure out a way to mimic what an egg can do. Both succeeded and both
discovered that all they had to do was add four genes to the cells and the cells
would turn into what look, so far, just like stem cells.
“It is actually fairly straightforward to repeat what we have done,” Dr. Thomson
said.
More work remains, but he is confident that the path ahead is clear.
“Isn’t it great to start a field and then to end it,” he said.
Man Who Helped Start Stem Cell War May End It, NYT,
22.11.2007,
http://www.nytimes.com/2007/11/22/science/22stem.html?hp
New Stem
Cell Method Could Ease Ethical Concerns
November
21, 2007
The New York Times
By GINA KOLATA
Two teams
of scientists are reporting today that they turned human skin cells into what
appear to be embryonic stem cells without having to make or destroy an embryo —
a feat that could quell the ethical debate troubling the field.
All they had to do, the scientists said, was add four genes. The genes
reprogrammed the chromosomes of the skin cells, making the cells into blank
slates that should be able to turn into any of the 220 cell types of the human
body, be it heart, brain, blood or bone. Until now, the only way to get such
human universal cells was to pluck them from a human embryo several days after
fertilization, destroying the embryo in the process.
The reprogrammed skin cells may yet prove to have subtle differences from
embryonic stem cells that come directly from human embryos, and the new method
includes potentially risky steps, like introducing a cancer gene. But stem cell
researchers say they are confident that it will not take long to perfect the
method and that today’s drawbacks will prove to be temporary.
Researchers and ethicists not involved in the findings say the work should
reshape the stem cell field. At some time in the near future, they said, today’s
debate over whether it is morally acceptable to create and destroy human embryos
to obtain stem cells should be moot.
“Everyone was waiting for this day to come,” said the Rev. Tadeiusz Pacholczyk,
director of education at the National Catholic Bioethics Center. “You should
have a solution here that will address the moral objections that have been
percolating for years,” he added.
The two independent teams, from Japan and Wisconsin, note that their method also
creates stem cells that genetically match the donor without having to resort to
the controversial step of cloning. If stem cells are used to make replacement
cells and tissues for patients, it would be invaluable to have genetically
matched cells because they would not be rejected by the immune system. Even more
important, scientists say, is that genetically matched cells from patients will
enable them to study complex diseases, like Alzheimer’s, in the lab.
Until now, the only way to get embryonic stem cells that genetically matched an
individual would be to create embryos that were clones of that person and
extract their stem cells. Just last week, scientists in Oregon reported that
they did this with monkeys, but the prospect of doing such experiments in humans
has been ethically fraught.
But with the new method, human cloning for stem cell research, like the creation
of human embryos to extract stem cells, may be unnecessary.
“It really is amazing,” said Dr. Leonard Zon, director of the stem cell program
at Harvard Medical School’s Children’s Hospital.
And, said Dr. Douglas Melton, co-director of the Stem Cell Institute at Harvard
University, it is “ethically uncomplicated.”
For all the hopes invested in it over the past decade, embryonic stem cell
research has not yet produced any cures or major therapeutic discoveries. Stem
cells are so malleable that they may pose risk of cancer, and the new method of
obtaining stem cells includes steps that raise their own safety concerns.
Still, the new work could allow the field to vault significant problems,
including the shortage of human embryonic stem cells and restrictions on federal
funding for such research. Even when scientists have other sources of funding,
they report that it is expensive and difficult to find women who will provide
eggs for such research.
The new discovery is being published online today in Cell, in a paper by Shinya
Yamanaka of Kyoto University and the Gladstone Institute for Cardiovascular
Disease in San Francisco, and in Science, in a paper by James Thomson and his
colleagues at the University of Wisconsin.
While both groups used just four genes to reprogram human skin cells, two of the
four genes used by the Japanese scientists were different from two of the four
used by the American group. All the genes in question, though, act in a similar
way – they are master regulator genes whose role is to turn other genes on or
off.
The reprogrammed cells, the scientists report, appear to behave exactly like
human embryonic stem cells.
“By any means we test them they are the same as embryonic stem cells,” Dr.
Thomson says.
He and Dr. Yamanaka caution, though, that they still must confirm that the
reprogrammed human skin cells really are the same as stem cells they get from
embryos. And while those studies are underway, Dr. Thomson and others say, it
would be premature to abandon research with stem cells taken from human embryos.
Another caveat is that , so far, scientists use a type of virus, a retrovirus,
to insert the genes into the cells’ chromosomes. Retroviruses slip genes into
chromosomes at random, sometimes causing mutations that can make normal cells
turn into cancers.
In addition, one of the genes that the Japanese scientists insert actually is a
cancer gene.
The cancer risk means that the resulting stem cells would not be suitable for
replacement cells or tissues for patients with diseases, like diabetes, in which
their own cells die. They would, though, be ideal for the sort of studies that
many researchers say are the real promise of this endeavor — studying the causes
and treatments of complex diseases.
For example, researchers want to make embryonic stem cells from a person with a
disease like Alzheimer’s and turn the stem cells into nerve cells in a petri
dish. Then, scientists hope, they may be able to understand what goes awry in
Alzheimer’s patients when their brain cells die and how to prevent or treat the
disease.
But even the retrovirus drawback may be temporary, scientists say. Dr. Yamanaka
and several other researchers are trying to get the same effect by adding
chemicals or using more benign viruses to get the genes into cells. They say
they are starting to see success.
It is only a matter of time until retroviruses are not needed, Dr. Melton
predicted.
“Anyone who is going to suggest that this is just a side show and that it won’t
work is wrong,” Dr. Melton said.
The new discovery was preceded by work in mice. Last year, Dr. Yamanaka
published a paper showing that he could add four genes to mouse cells and turn
them into mouse embryonic stem cells.
He even completed the ultimate test to show that the resulting stem cells could
become any type of mouse cell. He used them to create new mice, whose every cell
came from one of those stem cells. Twenty percent of those mice, though,
developed cancer, illustrating the risk of using retroviruses and a cancer gene
to make cells for replacement parts.
Scientists were electrified by the reprogramming discovery, Dr. Melton said.
“Once it worked, I hit my forehead and said, ‘it’s so obvious,’ ”he said. “But
it’s not obvious until it’s done.”
Some were skeptical about Dr. Yamanaka’s work and questioned whether such an
approach would ever work in humans.
“They said, ‘That’s very good with mice. But let’s see if you can do it with a
human,”’ Dr. Zon recalled.
But others set off in what became an international race to repeat the work with
human cells.
“Dozens, if not hundreds of labs, have been attempting to do this,” said Dr.
George Daley, associate director of the stem cell program at Children’s
Hospital.
Few expected Dr. Yamanka would succeed so soon. Nor did they expect that the
same four genes would reprogram human cells.
“This shows it’s not an esoteric thing that happened in the mouse,” said Rudolf
Jaenisch, a stem cell researcher at M.I.T.
Ever since the birth of Dolly the sheep, scientists knew that adult cells could,
in theory, turn into embryonic stem cells. But they had no idea how to do it
without cloning, the way Dolly was created.
With cloning, researchers put an adult cell’s chromosomes into an unfertilized
egg whose genetic material was removed. The egg, by some mysterious process,
then does all the work. It reprograms the adult cell’s chromosomes, bringing
them back to the state they were in just after the egg was fertilized. Those
reprogrammed genes then direct the development of an embryo. A few days later, a
ball of stem cells emerges in the embryo. Since the embryo’s chromosomes came
from the adult cell, every cell of the embryo, including its stem cells, are
exact genetic matches of the adult.
The abiding question, though, was, How did the egg reprogram the adult cell’s
chromosomes? Would it be possible to reprogram an adult cell without using an
egg?
About four years ago, Dr. Yamanaka and Dr. Thomson independently hit upon the
same idea. They would search for genes that are being used in an embryonic stem
cell that are not being used in an adult cell. Then they would see if those
genes would reprogram an adult cell.
Dr. Yamanaka worked with mouse cells and Dr. Thomson worked with human cells
from foreskins.
The researchers found more than 1,000 candidate genes. So both groups took
educated guesses, trying to whittle down the genes to the few dozen they thought
might be the crucial ones and then asking whether any combinations of those
genes could turn a skin cell into a stem cell.
It was laborious work, with no guarantee of a payoff.
“The number of factors could have been one or ten or 100 or more,” Dr. Yamanaka
said in a telephone interview from his lab in Japan.
If many genes were required, the experiments would have failed, Dr. Thomson
said, because it would be impossible to test all the gene combinations.
The mouse work went more quickly than Dr. Thomson’s work with human cells. As
soon as Dr. Yamanaka saw that the mouse experiments succeeded, he began trying
the same brute force method in human skin cells that he ordered from a
commercial laboratory. Some were face cells from a 36 year old white woman and
others were connective tissue cells from joints of a 69 year old white man.
Dr. Yamanaka said he thought it would take a few years to find the right genes
and the right conditions to make the human experiments work. Feeling the hot
breath of competitors on his neck, he was in his lab every day for 12 to 14
hours a day, he said.
A few months later, he succeeded.
“We did work very hard,” Dr. Yamanaka said. “But we were very surprised.”
New Stem Cell Method Could Ease Ethical Concerns, NYT,
21.11.2007,
http://www.nytimes.com/2007/11/21/science/21stem.html?hp
Stem
Cell Breakthrough Reported
November
20, 2007
Filed at 9:59 a.m. ET
By THE ASSOCIATED PRESS
The New York Times
NEW YORK
(AP) -- Scientists have made ordinary human skin cells take on the
chameleon-like powers of embryonic stem cells, a startling breakthrough that
might someday deliver the medical payoffs of embryo cloning without the
controversy.
Laboratory teams on two continents report success in a pair of landmark papers
released Tuesday. It's a neck-and-neck finish to a race that made headlines five
months ago, when scientists announced that the feat had been accomplished in
mice.
The ''direct reprogramming'' technique avoids the swarm of ethical, political
and practical obstacles that have stymied attempts to produce human stem cells
by cloning embryos.
Scientists familiar with the work said scientific questions remain and that it's
still important to pursue the cloning strategy, but that the new work is a major
coup.
''This work represents a tremendous scientific milestone -- the biological
equivalent of the Wright Brothers' first airplane,'' said Dr. Robert Lanza,
chief science officer of Advanced Cell Technology, which has been trying to
extract stem cells from cloned human embryos.
''It's a bit like learning how to turn lead into gold,'' said Lanza, while
cautioning that the work is far from providing medical payoffs.
''It's a huge deal,'' agreed Rudolf Jaenisch, a prominent stem cell scientist at
the Whitehead Institute in Cambridge, Mass. ''You have the proof of principle
that you can do it.''
There is a catch. At this point, the technique requires disrupting the DNA of
the skin cells, which creates the potential for developing cancer. So it would
be unacceptable for the most touted use of embryonic cells: creating transplant
tissue that in theory could be used to treat diseases like diabetes,
Parkinson's, and spinal cord injury.
But the DNA disruption is just a byproduct of the technique, and experts said
they believe it can be avoided.
The new work is being published online by two journals, Cell and Science. The
Cell paper is from a team led by Dr. Shinya Yamanaka of Kyoto University; the
Science paper is from a team led by Junying Yu, working in the lab of in
stem-cell pioneer James Thomson of the University of Wisconsin-Madison.
Both reported creating cells that behaved like stem cells in a series of lab
tests.
Thomson, 48, made headlines in 1998 when he announced that his team had isolated
human embryonic stem cells.
Yamanaka gained scientific notice in 2006 by reporting that direct reprogramming
in mice had produced cells resembling embryonic stem cells, although with
significant differences. In June, his group and two others announced they'd
created mouse cells that were virtually indistinguishable from stem cells.
For the new work, the two men chose different cell types from a tissue supplier.
Yamanaka reprogrammed skin cells from the face of an unidentified 36-year-old
woman, and Thomson's team worked with foreskin cells from a newborn. Thomson,
who was working his way from embryonic to fetal to adult cells, said he's still
analyzing his results with adult cells.
Both labs did basically the same thing. Each used viruses to ferry four genes
into the skin cells. These particular genes were known to turn other genes on
and off, but just how they produced cells that mimic embryonic stem cells is a
mystery.
''People didn't know it would be this easy,'' Thomson said. ''Thousands of labs
in the United States can do this, basically tomorrow.''
The Wisconsin Alumni Research Foundation, which holds three patents for
Thomson's work, is applying for patents involving his new research, a
spokeswoman said. Two of the four genes he used were different from Yamanaka's
recipe.
Scientists prize embryonic stem cells because they can turn into virtually any
kind of cell in the body. The cloning approach -- which has worked so far only
in mice and monkeys -- should be able to produce stem cells that genetically
match the person who donates body cells for cloning.
That means tissue made from the cells should be transplantable into that person
without fear of rejection. Scientists emphasize that any such payoff would be
well in the future, and that the more immediate medical benefits would come from
basic research in the lab.
In fact, many scientists say the cloning technique has proven too expensive and
cumbersome in its current form to produce stem cells routinely for transplants.
The new work shows that the direct reprogramming technique can also produce
versatile cells that are genetically matched to a person. But it avoids several
problems that have bedeviled the cloning approach.
For one thing, it doesn't require a supply of unfertilized human eggs, which are
hard to obtain for research and subjects the women donating them to a surgical
procedure. Using eggs also raises the ethical questions of whether women should
be paid for them.
In cloning, those eggs are used to make embryos from which stem cells are
harvested. But that destroys the embryos, which has led to political opposition
from President Bush, the Roman Catholic church and others.
Those were ''show-stopping ethical problems,'' said Laurie Zoloth, director of
Northwestern University's Center for Bioethics, Science and Society.
The new work, she said, ''redefines the ethical terrain.''
Richard Doerflinger, deputy director of pro-life activities for the U.S.
Conference of Catholic Bishops, called the new work ''a very significant
breakthrough in finding morally unproblematic alternatives to cloning. ... I
think this is something that would be readily acceptable to Catholics.''
Another advantage of direct reprogramming is that it would qualify for federal
research funding, unlike projects that seek to extract stem cells from human
embryos, noted Doug Melton, co-director of the Harvard Stem Cell Institute.
Still, scientific questions remain about the cells produced by direct
reprogramming, called ''iPS'' cells. One is how the cells compare to embryonic
stem cells in their behavior and potential. Yamanaka said his work detected
differences in gene activity.
If they're different, iPS cells might prove better for some scientific uses and
cloned stem cells preferable for other uses. Scientists want to study the roots
of genetic disease and screen potential drug treatments in their laboratories,
for example.
Scottish researcher Ian Wilmut, famous for his role in cloning Dolly the sheep a
decade ago, told London's Daily Telegraph that he is giving up the cloning
approach to produce stem cells and plans to pursue direct reprogramming instead.
Other scientists said it's too early for the field to follow Wilmut's lead.
Cloning embryos to produce stem cells remains too valuable as a research tool,
Jaenisch said.
Dr. George Daley of the Harvard institute, who said his own lab has also
achieved direct reprogramming of human cells, said it's not clear how long it
will take to get around the cancer risk problem. Nor is it clear just how direct
reprogramming works, or whether that approach mimics what happens in cloning, he
noted.
So the cloning approach still has much to offer, he said.
Daley, who's president of the International Society for Stem Cell Research, said
his lab is pursuing both strategies.
''We'll see, ultimately, which one works and which one is more practical.''
------
On the Net:
Journal Cell: http://www.cell.com
Journal Science: http://www.sciencemag.org
Stem Cell Breakthrough Reported, NYT, 20.11.2007,
http://www.nytimes.com/aponline/us/AP-Stem-Cells.html
Questions, Answers on Stem Cells
November
20, 2007
Filed at 9:20 a.m. ET
By THE ASSOCIATED PRESS
The New York Times
Embryonic
stem cells can develop into all kinds of tissue. Scientists have long sought to
find a way to create such cells that are genetically matched to patients,
because of the potential for new ways to treat disease and injury.
They've pursued this through cloning, which uses embryos. But through a new
method, ''direct reprogramming,'' scientists have found a way to produce cells
that appear virtually identical to stem cells, without using embryos.
Q: How big a breakthrough is this?
A: Huge. One researcher compared it to the Wright Brothers' airplane. Ian
Wilmut, who cloned Dolly the sheep, said he is dropping the cloning approach for
stem cells to begin testing this new method.
Q: What's so great about this new approach?
A: It doesn't require women's unfertilized eggs to make embryos; human eggs are
in short supply for research. And it doesn't involve the destruction of embryos,
which is required to harvest stem cells from within them. That destruction has
led some groups to oppose the cloning approach for ethical and religious
reasons.
Q: Does this mean scientists will no longer need human eggs or embryos?
A: No. Scientists say research should continue on embryonic stem cells. But this
new development will likely reduce the demand.
Q: How does the new method work?
A: Four genes were inserted into each skin cell. Scientists knew these
particular genes turn other genes on and off, but how the combination converted
skin cells into mimics of stem cells remains a mystery.
Q: Are these cells so-called ''adult stem cells?''
A: No. That term refers to cells found in the body that already have the ability
to morph into a variety of cell types. They don't need the four-gene treatment.
Q: Are there any drawbacks to this new approach?
A: At this early stage, the technique being used disrupts the DNA of the skin
cells, which leads to a potential for cancer. For now, that makes it
unacceptable as a way to create stem cells for disease treatment. But the DNA
disruption is just a byproduct of the technique, and experts believe there is a
way to avoid it.
Q: What does it mean for average people? Can we expect to see new treatments
anytime soon?
A: Not for years. Besides overcoming the cancer obstacle, scientists still have
to answer basic questions about these cells. In medicine, these cells would
probably be used first for lab studies like screening potential drugs.
Questions, Answers on Stem Cells, NYT, 20.11.2007,
http://www.nytimes.com/aponline/us/AP-Stem-Cells-QA.html
Heart
Disease Kills More Women Under 45
November
20, 2007
Filed at 7:42 a.m. ET
By THE ASSOCIATED PRESS
The New York Times
ATLANTA
(AP) -- For decades, heart disease death rates have been falling. But a new
study shows a troubling turn -- more women under 45 are dying of heart disease
due to clogged arteries, and the death rate for men that age has leveled off.
Heart experts aren't sure what went wrong, but they think increasing rates of
obesity and other risk factors are to blame.
The rates will have to be monitored to see if this is the beginning of a real
trend. But if the data holds, the new study may be an early glimpse of the
impact of escalating obesity and diabetes on U.S. deaths, said Wayne Rosamond, a
University of North Carolina epidemiology professor and expert on heart disease
statistics.
''This could be a harbinger of things to come,'' Rosamond said.
To be sure, the overall trend is still positive: From 1980 through 2002, the
death rate from blocked heart arteries was cut in half for men and women over
35. Improvements in treatment and preventive measures, including
cholesterol-lowering medications, get the credit.
But what's going on with younger adults is startling, said Dr. Anthony DeMaria,
editor of the Journal of the American College of Cardiology, which is publishing
the study and released it Monday.
''We have a pretty rosy view of how things are going in the war against
cardiovascular disease,'' DeMaria said. ''I view this paper as a wake-up call
that says there is a very important segment of our population that needs some
attention.''
Heart disease is the leading cause of death in the United States, killing almost
700,000 Americans each year.
Nearly 500,000 of those deaths are attributed to coronary heart disease, in
which fat and plaque clog the arteries feeding blood to the heart, sometimes
called hardening of the arteries. Heart attacks are a common result.
It can take many years for arteries to get dangerously blocked. About 93 percent
of deaths occur in people 55 and older.
But a combination of factors -- including genetics, obesity and high cholesterol
-- are sometimes fatal for younger adults. In 2002, about 25,000 men and 8,000
women ages 35 to 54 died of coronary heart disease.
The study was done by researchers at the U.S. Centers for Disease Control and
Control and Prevention and Britain's University of Liverpool. They looked at
U.S. vital statistics for artery-related deaths in adults ages 35 and older for
the years 1980 through 2002, the most recent year for which data was available
when the analysis was done.
When they compared age groups, they detected the worrisome difference. The study
found the death rate for women ages 35 to 44 rose from 1997 to 2002, when the
rate was 8.2 per 100,000 women, the highest it's been since 1987.
In actual numbers, the increase amounts to roughly 100 added deaths a year of
women in that age group. That's a relatively small impact in the entire U.S.
population.
Still, the results are statistically significant and a legitimate cause for
concern, said Dr. Wayne Giles, director of the CDC's division of adult and
community health.
''That's like an MD-88 crashing every year,'' he said, referring to a
medium-size commuter jet plane.
The rates for men age 35 to 44 were relatively stable in the last few years of
the study period. The rate was 26 deaths per 100,000 men in that age group in
2002.
The fact the male rate didn't worsen may indicate doctors are more likely to
suspect heart disease in men that age than in women, said the CDC's Dr. Earl
Ford, a study co-author.
For all ages, the female death rate fell to 261 from 514 per 100,000; the male
rate fell to 430 from 898 per 100,000.
------
On the Net:
Journal of the American College of Cardiology: http://
www.acc.org/JACC/Ford.pdf
Heart Disease Kills More Women Under 45, NYT, 20.11.2007,
http://www.nytimes.com/aponline/us/AP-Heart-Disease-Deaths.html
The DNA Age
My
Genome, Myself: Seeking Clues in DNA
November
17, 2007
The New York Times
By AMY HARMON
The
exploration of the human genome has long been relegated to elite scientists in
research laboratories. But that is about to change. An infant industry is
capitalizing on the plunging cost of genetic testing technology to offer any
individual unprecedented — and unmediated — entree to their own DNA.
For as little as $1,000 and a saliva sample, customers will be able to learn
what is known so far about how the billions of bits in their biological code
shape who they are. Three companies have already announced plans to market such
services, one yesterday.
Offered the chance to be among the early testers, I agreed, but not without
reservations. What if I learned I was likely to die young? Or that I might have
passed on a rogue gene to my daughter? And more pragmatically, what if an
insurance company or an employer used such information against me in the future?
But three weeks later, I was already somewhat addicted to the daily communion
with my genes. (Recurring note to self: was this addiction genetic?)
For example, my hands hurt the other day. So naturally, I checked my DNA.
Was this the first sign that I had inherited the arthritis that gnarled my
paternal grandmother’s hard-working fingers? Logging onto my account at 23andMe,
the start-up company that is now my genetic custodian, I typed my search into
the “Genome Explorer” and hit return. I was, in essence, Googling my own DNA.
I had spent hours every day doing just that as new studies linking bits of DNA
to diseases and aspects of appearance, temperament and behavior came out on an
almost daily basis. At times, surfing my genome induced the same shock of
recognition that comes when accidentally catching a glimpse of oneself in the
mirror.
I had refused to drink milk growing up. Now, it turns out my DNA is devoid of
the mutation that eases the digestion of milk after infancy, which became common
in Europeans after the domestication of cows.
But it could also make me question my presumptions about myself. Apparently I
lack the predisposition for good verbal memory, although I had always prided
myself on my ability to recall quotations. Should I be recording more of my
interviews? No, I decided; I remember what people say. DNA is not definitive.
I don’t like brussels sprouts. Who knew it was genetic? But I have the snippet
of DNA that gives me the ability to taste a compound that makes many vegetables
taste bitter. I differ from people who are blind to bitter taste — who actually
like brussels sprouts — by a single spelling change in our four-letter genetic
alphabet: somewhere on human chromosome 7, I have a G where they have a C.
It is one of roughly 10 million tiny differences, known as single nucleotide
polymorphisms, or SNPs (pronounced “snips”) scattered across the 23 pairs of
human chromosomes from which 23andMe takes its name. The company generated a
list of my “genotypes” — AC’s, CC’s, CT’s and so forth, based on which versions
of every SNP I have on my collection of chromosome pairs.
For instance, I tragically lack the predisposition to eat fatty foods and not
gain weight. But people who, like me, are GG at the SNP known to geneticists as
rs3751812 are 6.3 pounds lighter, on average, than the AA’s. Thanks, rs3751812!
And if an early finding is to be believed, my GG at rs6602024 mean that I am an
additional 10 pounds lighter than those whose genetic Boggle served up a
different spelling. Good news, except that now I have only my slothful ways to
blame for my inability to fit into my old jeans.
And although there is great controversy about the role that genes play in
shaping intelligence, it was hard to resist looking up the SNPs that have been
linked — however tenuously — to I.Q. Three went in my favor, three against. But
I found hope in a study that appeared last week describing a SNP strongly linked
with an increase in the I.Q. of breast-fed babies.
Babies with the CC or CG form of the SNP apparently benefit from a fatty acid
found only in breast milk, while those with the GG form do not. My CC genotype
meant that I had been eligible for the 6-point I.Q. boost when my mother
breast-fed me. And because, by the laws of genetics, my daughter had to have
inherited one of my C’s, she, too, would see the benefit of my having nursed
her. Now where did I put those preschool applications?
I was not always so comfortable in my own genome. Before I spit into the vial, I
called several major insurance companies to see if I was hurting my chances of
getting coverage. They said no, but that is now, when almost no one has such
information about their genetic make-up. In five years, if companies like
23andMe are at all successful, many more people presumably would. And isn’t an
individual’s relative risk of disease precisely what insurance companies want to
know?
Last month, alone in a room at 23andMe’s headquarters in Mountain View, Calif.,
with my password for the first time, I wavered (genetic?) and walked down the
hall to get lunch.
Once I looked at my results, I could never turn back. I had prepared for the
worst of what I could learn this day. But what if something even worse came
along tomorrow?
Some health care providers argue that the public is unprepared for such
information and that it is irresponsible to provide it without an expert to help
put it in context. And at times, as I worked up the courage to check on my risks
of breast cancer and Alzheimer’s, I could see their point.
One of the companies that plans to market personal DNA information, Navigenics,
intends to provide a phone consultation with a genetic counselor along with the
results. Its service would cost $2,500 and would initially provide data on 20
health conditions.
DeCODE Genetics and 23andMe will offer referrals. Although what they can tell
you is limited right now, all three companies are hoping that people will be
drawn by the prospect of instant updates on what is expected to be a flood of
new findings.
I knew I would never be able to pass up the chance to fill in more pieces of my
genetic puzzle.
But I had decided not to submit my daughter’s DNA for testing — at least not yet
— because I didn’t want to regard anything about her as predestined. If she
wants to play the piano, who cares if she lacks perfect pitch? If she wants to
run the 100-meter dash, who cares if she lacks the sprinting gene? And did I
really want to know — did she really want to know someday — what genes she got
from which parent and which grandparent?
I, however, am not age 3. Whatever was lurking in my genes had been there my
entire life. Not looking would be like rejecting some fundamental part of
myself.
Compelled to know (genetic?), I breezed through the warning screens on the site.
There would be no definitive information, I read, and new discoveries might
reverse whatever I was told. Even if I learned that my risk for developing a
disease was high, there might well be nothing to do about it, and, besides, I
should not regard this as a medical diagnosis. “If, after considering these
points, you still wish to view your results,” the screen read, “click here.”
I clicked.
Like other testers of 23andMe’s service, my first impulse was to look up the
bits of genetic code associated with the diseases that scare me the most.
But in the bar charts that showed good genes in green and bad ones in red, I
found a perverse sense of accomplishment. My risk of breast cancer was no higher
than average, as was my chance of developing Alzheimer’s. I was 23 percent less
likely to get Type 2 diabetes than most people. And my chance of being paralyzed
by multiple sclerosis, almost nil. I was three times more likely than the
average person to get Crohn’s disease, but my odds were still less than one in a
hundred.
I was in remarkably good genetic health, and I hadn’t even been to the gym in
months!
Still, just studying my DNA had made me more acutely aware of the basic health
risks we all face. I renounced my midafternoon M&M’s.
And then I opened my “Gene Journal” for heart disease to find that I was 23
percent more likely than average to have a heart attack. “Healthy lifestyle
choices play a major role in preventing the blockages that lead to heart
attacks,” it informed me.
Thanks, Gene Journal. Yet somehow even this banal advice resonated when the
warning came from my own DNA.
Back in New York, I headed to the gym despite a looming story deadline and my
daughter’s still-unfinished preschool applications. At least I had more time. I
had discovered a SNP that likely increased my life span.
But in what I have come to accept as the genomic law of averages, I soon found
that I might well be sight impaired during those extra years. According to the
five SNPs for macular degeneration I fed into the “Genome Explorer,” I was
nearly 100 times more likely to develop the disease than someone with the most
favorable A-C-G-T combination.
And unlike the standard eat-right-and-exercise advice for heart health, there
was not much I could do about it. Still, I found the knowledge of my potential
future strangely comforting, even when it was not one I would wish for. At least
my prospects for nimble fingers in old age were looking brighter. I didn’t have
the bad form of that arthritis SNP.
Maybe I was just typing too much.
My Genome, Myself: Seeking Clues in DNA, NYT, 17.11.2007,
http://www.nytimes.com/2007/11/17/us/17dna.html?ref=opinion
Scientists Use Monkey Clones to Extract Stem Cells
November
15, 2007
The New York Times
By GINA KOLATA
Researchers
in Oregon are reporting that they used cloning to produce monkey embryos and
then extracted stem cells from the embryos.
Not only is this the first time such cells have been produced in any animal
other than a mouse, but the method, the researchers say, should also work in
humans. In 2004, South Korean researchers reported making stem cells from cloned
human embryos, but the claim turned out fraudulent.
“We hope the technology will be useful for other labs that are working on human
eggs and human cells,” the lead researcher of the group, Shoukhrat Mitalipov at
Oregon Health and Science University in Beaverton, said in a telephone
interview. “I am quite sure it will work in humans.”
The monkey stem cells were genetically identical to an adult monkey, Semos,
whose cells were cloned. They are a sort of universal cell that can, in theory,
develop into any tissue or organ.
Medical researchers and patient advocacy groups have long hoped to use human
embryonic stem cells to study diseases and supply replacement cells to treat
them. So far, though, stem cell research has not yielded cures, and many
obstacles lie ahead.
An advantage of using cloning to obtain stem cells is that they would
genetically match a patient’s cells, making it unnecessary to suppress the
immune system if the stem cells are used in treatment. Cloning could also
produce stem cells that genetically match patients with complex diseases like
Alzheimer’s. That might let scientists study those cells and understand how the
diseases progress.
With the monkey work, some researchers say, cloned human embryonic stem cells
seem more feasible. There is no way to know, of course, whether it will be
harder or easier to repeat the work with humans. “I’m very enthusiastic,” said
Dr. Leonard Zon, director of the stem cell program at Harvard’s Children’s
Hospital. “The next step is definitely doing it in humans.”
Groups opposing human cloning and the destruction of human embryos to extract
stem cells say the report makes it more urgent than ever to draw a moral line.
“I certainly think that this represents a new threshold in the entire
discussion,” said the Rev. Tadeusz Pacholczyk, director of education at the
National Catholic Bioethics Center. “At this point, it becomes essential to ask
a question as a society: Are there ever going to be circumstances where it is
morally justifiable to clone human beings?”
The report on cloned stem cells, which appears in the Nov. 22 issue of Nature,
was published online yesterday, after some details of the work had filtered into
the news media.
Dr. Mitalipov said his team showed that the cloned cells had features
characteristic of universal cells. For instance, they developed into monkey
heart cells and nerve cells.
The team also put the cells in mice, where they turned into a wide array of cell
types.
The stem cells, Dr. Mitalipov says, “can contribute to any cell of the body.”
The scientists began by removing skin cells from a 9-year-old adult male rhesus
macaque and inserted them, along with all their genes, into monkey eggs whose
genetic material had been removed.
The egg, in a part of the cloning process that remains mysterious, reprogrammed
the genes from the skin cells, bringing them back to the state they were in when
embryo development begins.
The reprogrammed genes took over developing the eggs. A result was monkey
embryos that were genetically identical — clones — of the adult male monkey. A
few days later, the investigators extracted stem cells from the embryo clones,
destroying the embryos in the process.
Most attempts at cloning failed. The investigators started with 304 egg cells
from 14 female macaques and ended up with two stem cell lines. One line had an
abnormal Y chromosome. The other, Dr. Mitalipov said, appeared normal.
But, he speculates, one reason for the success was finding a gentle way to take
the genetic material out of monkey eggs.
In previous attempts, the investigators had used a method that worked well in
mice. They marked the egg’s chromosomes with a dye that glowed under ultraviolet
light. That let them see the chromosomes and be sure that they were removed
before they inserted the adult cell with its genes into the egg.
The dye and ultraviolet light, the researchers surmised, might damage the egg.
So they used a new method that shines polarized light through the egg, allowing
them to see the chromosomes directly, without dyes.
Randall Prather, professor of reproductive biotechnology at the University of
Missouri, said he had had similar problems with the dyes and ultraviolet light
when he tried to clone pigs. His group succeeded by going in blindly and
plucking the nuclei out of the pigs’ eggs, he said.
“Each system has a quirk to make it work,” Dr. Prather said.
Dr. Mitalipov said that once his group decided to use its modified methods of
producing the cloned embryos, it took just a few months to produce the stem
cells.
Dr. Mitalipov says his group’s next project is to use its new method to try to
create cloned monkeys that carry genes for human diseases. The researchers would
add human disease genes to adult skin cells before starting the cloning.
A result would be cloned monkeys that had the human disease gene in every cell.
Scientists could study those monkeys to understand the causes and treatment of
the disease.
“We hope,” Dr. Mitalipov said, “to model every known human disease.”
Scientists Use Monkey Clones to Extract Stem Cells, NYT, 15.11.2007,
http://www.nytimes.com/2007/11/15/science/15primate.html?hp
Four
Transplant Recipients Contract H.I.V.
November
14, 2007
The New York Times
By DENISE GRADY
Four
transplant recipients in Chicago have contracted H.I.V. from an organ donor, the
first known cases in more than a decade in which the virus was spread by organ
transplants.
The organs also gave all four patients hepatitis C, in what health officials
said was the first reported instance in which the two viruses were spread
simultaneously by a transplant.
Though exceedingly rare, this type of transmission highlights a known weakness
in the system for checking organ donors for infection: the most commonly used
tests can fail to detect viral diseases if they are performed too early in the
course of the infection. Officials say the events in Chicago may lead to
widespread changes in testing methods.
“There are important policy implications,” said Dr. Matthew Kuehnert, director
of the Office of Blood, Organ and Other Tissue Safety at the federal Centers for
Disease Control and Prevention, which is investigating the case. “Clearly, the
organ transplant community is going to think about the issues raised by this,
and we look forward to being involved in those discussions.”
The cases were first reported yesterday by The Chicago Tribune. Two patients
were infected at the University of Chicago Medical Center, and one each at Rush
University Medical Center and Northwestern Memorial Hospital. The transplants
were coordinated by an organization called the Gift of Hope of Elmhurst, Ill.
Officials would not say what organs were transplanted, but a transplant expert
not connected with the case said they were most likely the kidneys, liver and
either the heart or lungs. Only four organs, and no other tissue, were taken
from the donor.
The University of Chicago said that the operations took place in January, and
that the donor was an adult who died in an Illinois hospital “three days after
traumatic injury.” Neither the donor’s age nor sex were disclosed. The other
hospitals declined to discuss what happened, except to confirm that each had an
infected patient.
The situation came to light earlier this month when one of the recipients, who
was being evaluated for a retransplant, tested positive for H.I.V. and hepatitis
C. At that point, blood preserved from the donor was given a highly sensitive
test for viruses, and the infection was found.
Dr. J. Michael Millis, the chief of transplantation at the University of
Chicago, said the patients were devastated, and the doctors heartbroken. But Dr.
Millis said the diseases were treatable.
Initially, the donor had tested negative for H.I.V. and hepatitis C, apparently
because the infection was too recent to be detected by commonly used blood
tests. Those tests do not find the virus itself, but instead look for the body’s
reaction to the infection — the antibodies produced by the immune system. But
the body takes time to react, and if the test is done too soon, within 22 days
of H.I.V. infection or 82 days for hepatitis C, antibodies may not yet be
detectable.
Doctors say that is what probably occurred in Chicago. It has always been known
that this kind of transmission was theoretically possible, but it was considered
highly unlikely. And indeed, since 1994 nearly 300,000 transplants from cadavers
have occurred without any reported cases of H.I.V. transmission.
Another more sensitive type of test can pick up viral infections earlier, but
was not used. That test looks for evidence of the virus itself, and can reduce
the “window,” the early period in which the test does not work, to 12 days for
H.I.V. and 25 days for hepatitis C.
That test, the nucleic acid amplification test, or Naat, is not widely
available, and doctors said it was more difficult and time-consuming than other
tests — and there is usually no time to spare with transplants because organs
deteriorate quickly when the donor dies. Another concern is that the test is
more likely than others to give false-positive results, and lead to the needless
destruction of healthy organs, a scarce resource.
Dr. Robert Brown, director of the liver transplant program at
NewYork-Presbyterian/Columbia said, “There is always a drive toward better
testing, but if it leads to more organ wastage, we’ll probably hurt more people
than we help.”
According to the University of Chicago, the organ donor in Illinois was known to
be “high risk,” based on a risk factor revealed by a close friend who provided
“a health and social history.” The exact nature of the risk was not disclosed.
Federal guidelines recommend against transplanting organs from high-risk people
unless the recipients are so likely to die for want of a transplant that H.I.V.
seems a lesser threat.
Dr. Millis said that he did not know whether the patients there had been
informed of the donor’s status.
About 9 percent of organ donors qualify as high-risk based on behaviors like
prostitution or drug use with needle-sharing. Transplant experts say the
percentage would probably be higher if they had full information on all donors.
Dr. Brown said Columbia got offers of organs from high-risk donors every week.
He also said that at Columbia, patients (or family members) were informed if a
donor was high risk, and were required to sign a special consent form
acknowledging it.
Dr. Millis said that although the organ supply was generally safe, he hoped it
could be made safer, probably by developing regional centers around the country
to perform Naat testing reliably and quickly enough to meet transplant needs.
Although it is rare, other diseases like rabies, West Nile fever and a rodent
virus called LCMV have also been spread by organ transplants. In all of those
cases, patients died.
Four Transplant Recipients Contract H.I.V., NYT,
14.11.2007,
http://www.nytimes.com/2007/11/14/health/healthspecial/14hiv.html
2 - Year
- Old Conjoined Twins Separated
November
13, 2007
Filed at 11:47 p.m. ET
By THE ASSOCIATED PRESS
The New York Times
SAN
FRANCISCO (AP) -- Two-year-old twin girls who were conjoined at the chest and
abdomen have been successfully separated in surgery that went ''much better than
anticipated,'' the lead surgeon said Tuesday.
Yurelia and Fiorella Rocha-Arias of San Jose, Costa Rica, underwent the
nine-hour surgery Monday. Though it went well, the odds of survival for such
separated conjoined twins is about 50 percent, Dr. Gary Hartman said.
''There's a lot of relief, but it's not really over,'' Hartman said in a phone
interview with The Associated Press. ''The point where we would relax
significantly would be when they're off the breathing machines.''
Yurelia and Fiorella are in the critical care facility at Lucile Packard
Children's Hospital in Palo Alto. Both are heavily sedated and have ventilators
and feeding tubes.
Yurelia is receiving intermittent paralyzing agents because she's going back to
the operating room later this week, where a cardiothoracic surgeon will try to
correct a serious heart defect.
Fiorella doesn't appear to need follow-up surgeries, and anesthesiologists will
lighten her sedation Tuesday or Wednesday, he said.
The girls' parents, Maria and Jose Luis Rocha-Arias, have requested privacy and
declined to comment.
The procedure was considered complicated, in part because the twins shared a
blood supply. The girls were connected at the right atria of their hearts, the
chamber that receives blood from the rest of the body.
Doctors had to clamp off valves to see what would happen if neither girl shared
blood with the other. Neither girl had problems, ''in fact, each of them in some
manner improved,'' Hartman said.
The girls also had appeared to share a liver, but the organ turned out to be two
individual livers fused at the widest point and successfully separated by
doctors.
Yurelia and Fiorella's parents moved from Nicaragua to Costa Rica, which has
better medical facilities, after an ultrasound showed conjoined twins. The
Nicaraguan embassy helped pay for the twins' care in Costa Rica. The girls
arrived in San Francisco on July 25.
Packard doctors are donating their time, and the hospital is donating medical
and clinical care, to treat Yurelia and Fiorella, who have nine older siblings.
Mending Kids International, a faith-based nonprofit based in Santa Clarita that
helps sick children, arranged transportation and housing.
Earlier this fall, Hartman estimated the cost of the surgery to be $1 million to
$2 million.
Researchers estimate the incidence of conjoined twins to be between 1 in 30,000
to 1 in 200,000 worldwide. Most do not survive pregnancy, and most born alive
die within 24 hours. About five separation surgeries are performed annually in
the United States.
2 - Year - Old Conjoined Twins Separated, NYT, 13.11.2007,
http://www.nytimes.com/aponline/us/AP-Conjoined-Twins.html
U.S.
Sets Record in Sexual Disease Cases
November
13, 2007
Filed at 12:16 p.m. ET
By THE ASSOCIATED PRESS
The New York Times
ATLANTA
(AP) -- More than 1 million cases of chlamydia were reported in the United
States last year -- the most ever reported for a sexually transmitted disease,
federal health officials said Tuesday.
''A new U.S. record,'' said Dr. John M. Douglas Jr. of the Centers for Disease
Control and Prevention.
More bad news: Gonorrhea rates are jumping again after hitting a record low, and
an increasing number of cases are caused by a ''superbug'' version resistant to
common antibiotics, federal officials said Tuesday.
Syphilis is rising, too. The rate of congenital syphilis -- which can deform or
kill babies -- rose for the first time in 15 years.
''Hopefully we will not see this turn into a trend,'' said Dr. Khalil Ghanem, an
infectious diseases specialist at Johns Hopkins University's School of medicine.
The CDC releases a report each year on chlamydia, gonorrhea and syphilis, three
diseases caused by sexually transmitted bacteria.
Chlamydia is the most common. Nearly 1,031,000 cases were reported last year, up
from 976,000 the year before.
The count broke the single-year record for reported cases of a sexually
transmitted disease, which was 1,013,436 cases of gonorrhea, set in 1978.
Putting those numbers into rates, there were about 349 cases of chlamydia per
100,000 people in 2006, up 5.6 percent from the 329 per 100,000 rate in 2005.
CDC officials say the chlamydia record may not be all bad news: They think the
higher number is largely a result of better and more intensive screening.
For more than 10 years, the CDC has recommended annual screening in sexually
active women ages 15 to 25. Meanwhile, urine and swab tests for the bacteria are
getting better and are used more often, for men as well as women, said Douglas,
director of the CDC's Division of Sexually Transmitted Disease Prevention.
About three-quarters of women infected with chlamydia have no symptoms. Left
untreated, the infection can spread and ultimately can lead to infertility. It's
easily treated if caught early.
Health officials believe as many as 2.8 million new cases may actually be
occurring each year, he added.
Gonorrhea is a different story.
In 2004, the nation's gonorrhea rate fell to 113.5 cases per 100,000 people in
2004, the lowest level since the government started tracking cases in 1941.
But since then, health officials have seen two consecutive years of increases.
The 2006 rate -- about 121 per 100,000 -- represents a 5.5 percent increase from
2005.
Health officials don't know exactly how many superbug cases there were among the
more than 358,000 gonorrhea cases reported in 2006. But a surveillance project
of 28 cities found that 14 percent were resistant to ciprofloxacin and other
medicines in the fluoroquinolones class of antibiotics.
Similar samples found that 9 percent were resistant to those antibiotics in
2005, and 7 percent were resistant in 2004. The appearance of the superbug has
been previously reported, and the CDC is April advised doctors to stop using
those drugs against gonorrhea.
Douglas said it doesn't look like the superbugs are the reason for gonorrhea's
escalating numbers overall, but they're not sure what is driving the increase.
Other doctors are worried. The superbug gonorrhea has been on the rise not only
in California and Hawaii, where the problem has been most noticeable, but also
in the South and parts of the Midwest.
''Suddenly we're starting to see the spread,'' Ghanem said.
Syphilis, a potentially deadly disease that first shows up as genital sores, has
become relatively rare in the United States. About 9,800 cases of the most
contagious forms or syphilis were reported in 2006, up from about 8,700 in 2005.
The rate rose from 2.9 cases per 100,000 people to 3.3, a 14 percent increase.
For congenital syphilis, in which babies get syphilis from their mothers, the
rate rose only slightly from the previous year to 8.5 cases per 100,000 live
births.
U.S. Sets Record in Sexual Disease Cases, NYT, 13.11.2007,
http://www.nytimes.com/aponline/us/AP-STD-Rates.html
US Among
Worst in World for Infant Death
November
11, 2007
Filed at 6:34 a.m. ET
By THE ASSOCIATED PRESS
The New York Times
The rate at
which infants die in the United States has dropped substantially over the past
half-century, but broad disparities remain among racial groups, and the country
stacks up poorly next to other industrialized nations.
In 2004, the most recent year for which statistics are available, roughly seven
babies died for every 1,000 live births before reaching their first birthday,
the Centers for Disease Control and Prevention says. That was down from about 26
in 1960.
Babies born to black mothers died at two and a half times the rate of those born
to white mothers, according to the CDC figures.
The United States ranks near the bottom for infant survival rates among
modernized nations. A Save the Children report last year placed the United
States ahead of only Latvia, and tied with Hungary, Malta, Poland and Slovakia.
The same report noted the United States had more neonatologists and newborn
intensive care beds per person than Australia, Canada and the United Kingdom --
but still had a higher rate of infant mortality than any of those nations.
Doctors and analysts blame broad disparities in access to health care among
racial and income groups in the United States.
Not surprisingly, the picture is far bleaker in poorer countries, particularly
in Africa. A 2005 World Health Organization report found infant mortality rates
as high as 144 per 1,000 births -- more than 20 times the U.S. rate -- in
Liberia.
US Among Worst in World for Infant Death, NYT, 11.11.2007,
http://www.nytimes.com/aponline/us/AP-Saving-the-Smallest-US-Picture.html
Merck
Agrees to Pay $4.85 Billion for Vioxx Claims
November 9,
2007
The New York Times
By ALEX BERENSON
Three years
after withdrawing its pain medication Vioxx from the market, Merck announced
today that it will pay $4.85 billion to settle 27,000 lawsuits by people who
contend they or their family members suffered injury or died after taking the
drug.
The settlement, one of the largest ever in civil litigation, comes after nearly
20 Vioxx civil trials over the last two years from New Jersey to California.
After losing a $253 million verdict in the first case, Merck has won most of the
rest of the cases that reached juries, giving plaintiffs little choice but to
settle.
The settlement will help put Vioxx behind Merck, as well as sharply reduce its
Vioxx-related legal defense fees, which are now running at more than $600
million annually.
Judges in Louisiana, New Jersey and California, who oversee nearly all the
lawsuits, had pressed for a deal before a new wave of trials was scheduled to
begin in January.
Plaintiffs will receive different settlement payments depending on the severity
of their injuries and the length of time they took Vioxx. The deal becomes
binding only if 85 percent of all plaintiffs agree to drop their cases and take
the deal.
Based on the fact that the 27,000 suits cover about 47,000 sets of plaintiffs,
the average plaintiff will receive just more than $100,000 before legal fees and
expenses, which usually swallow 30 percent to 50 percent of payments to
plaintiffs. Plaintiffs who do not want to accept the settlement can pursue their
own claims, but with so many of the top trial lawyers in the United States
agreeing to the deal, they may have difficulty doing so.
After several weeks of negotiations, Merck reached the settlement with lawyers
who are on the steering committee that represents attorneys for the plaintiffs
who have sued Merck in federal court. Those lawyers, and a handful of others,
represent most of the 47,000 different groups of plaintiffs.
“It’s a fantastic deal,” said Danny Becnel, a Louisiana lawyer who said he
represented about 1,000 plaintiffs. Mr. Becnel credited Judge Eldon E. Fallon of
Federal District Court, who is overseeing the federal lawsuits from his court in
New Orleans, with pressing the two sides to the table.
“He had everything to do with it,” Mr. Becnel said. “He was critical.”
The settlement does not end the government investigations that Merck faces,
which include both civil and criminal inquires from several states and the
Justice Department.
But for Merck, which has already spent more than $1.2 billion on Vioxx-related
legal fees, the settlement will put to rest any fears that Vioxx lawsuits might
bankrupt the company, or even have a significant financial impact. While
eye-popping, the settlement payment represents less than one year’s profits for
the company, the third-largest American drug maker.
For plaintiffs, the settlement will provide a measure of vindication and
financial relief. And plaintiffs’ firms will earn nearly $2 billion in fees at
their standard rates of 33 percent to 40 percent.
But the agreement is far smaller than Wall Street analysts and lawyers predicted
when Merck withdrew Vioxx, and especially after the verdict in the first case.
In 2005, most analysts estimated that Merck’s ultimate liability in Vioxx would
be between $10 billion and $25 billion.
Merck withdrew Vioxx from the market in September 2004, after a clinical trial
proved that it increased the risks of heart attacks and strokes. But internal
company documents showed that Merck’s scientists were concerned about the risks
of Vioxx several years earlier. And a large clinical trial that ended in 2000
also showed that Vioxx was much riskier than naproxen, an older painkiller sold
under the name Aleve.
The settlement vindicates Merck’s risky decision to take cases to trial rather
than agree to a quick, early settlement. By aggressively defending itself, Merck
exposed the weaknesses in many plaintiffs’ cases. Some plaintiffs could not
prove they had taken the drug, and others were overweight, smoked, or had other
risk factors for heart attacks.
That strategy looked as though it had badly backfired in August 2005, when a
jury in Angleton, Tex., returned a verdict of $253.5 million on behalf of Carol
Ernst, whose husband, Robert, had died after taking Vioxx for less than a year.
But Merck decided to stick to its strategy, continuing to insist it would not
settle cases. And in a series of cases in 2006 and 2007, Merck defeated
plaintiffs in California, Florida, New Jersey, Illinois and Louisiana, while
losing only a handful of cases.
Merck Agrees to Pay $4.85 Billion for Vioxx Claims, NYT,
9.11.2007,
http://www.nytimes.com/2007/11/09/business/09cnd-merck.html
Autism
Epidemic
May Be All in the Label
November 4,
2007
Filed at 9:30 a.m. ET
By THE ASSOCIATED PRESS
The New York Times
ATLANTA
(AP) -- A few decades ago, people probably would have said kids like Ryan Massey
and Eddie Scheuplein were just odd. Or difficult.
Both boys are bright. But Ryan, 11, is hyper and prone to angry outbursts,
sometimes trying to strangle another kid in his class who annoys him. Eddie, 7,
has a strange habit of sticking his shirt in his mouth and sucking on it.
Both were diagnosed with a form of autism. And it's partly because of children
like them that autism appears to be skyrocketing: In the latest estimate, as
many as one in 150 children have some form of this disorder. Groups advocating
more research money call autism ''the fastest-growing developmental disability
in the United States.''
Indeed, doctors are concerned there are even more cases out there, unrecognized:
The American Academy of Pediatrics last week stressed the importance of
screening every kid -- twice -- for autism by age 2.
But many experts believe these unsociable behaviors were just about as common 30
or 40 years ago. The recent explosion of cases appears to be mostly caused by a
surge in special education services for autistic children, and by a
corresponding shift in what doctors call autism.
Autism has always been diagnosed by making judgments about a child's behavior;
there are no blood or biologic tests. For decades, the diagnosis was given only
to kids with severe language and social impairments and unusual, repetitious
behaviors.
Many children with severe autism hit themselves or others, don't speak and don't
make eye contact.
Blake Dees, a 19-year-old from Suwanee, Ga., falls into that group. For the past
eight years, he has been in a day program with intense services, but he still
doesn't talk, he's not toilet-trained, and he has a history of trying to eat
anything -- even broken glass.
But he's not a typical case.
In the 1990s, the autism umbrella expanded, and autism is now shorthand for a
group of milder, related conditions, known as ''autism spectrum disorders.''
The spectrum includes Asperger's syndrome and something called PDD-NOS (for
Pervasive Developmental Disorder-Not Otherwise Specified). Some support groups
report more than half of their families fall into these categories, but there is
no commonly accepted scientific breakdown.
Gradually, there have been changes in parents' own perception of autism, the
autism services schools provide, and the care that insurers pay for, experts
say.
Eddie, of Buford, Ga., was initially diagnosed with obsessive-compulsive
disorder, attention deficit hyperactivity disorder and other conditions. But the
services he got in school were not very helpful.
His mother, Michelle, said a diagnosis of autism brought occupational therapy
and other, better services.
''I do have to admit I almost like the idea of having the autistic label, at
least over the other labels, because there's more help out there for you,'' said
Scheuplein.
''The truth is there's a powerful incentive for physicians and schools to
classify children in a way that gets services,'' said Dr. Edwin Trevathan of the
U.S. Centers for Disease Control and Prevention.
Many with Asperger's and PDD-NOS succeed in school and do not -- at first glance
-- have much in common with children like Blake Dees.
At a recent gathering of families with Asperger's children in the Atlanta area,
parents told almost comical stories about kids who frequently pick their noses,
douse food in ketchup or wear the same shirt day after day.
Such a frank, humorous exchange was once a rarity. Doctors for many years
believed in the ''refrigerator mom'' theory, which held that autism was the
result of being raised by a cold, unloving mother. The theory became
discredited, but was difficult to dislodge from the popular conscience.
Even in the early 1980s, some parents were more comfortable with a diagnosis of
mental retardation than autism, said Trevathan, director of the CDC's National
Center on Birth Defects and Developmental Disabilities.
Today, parents are more likely to cringe at a diagnosis of mental retardation,
which is sometimes equated to a feeble-mindedness and may obscure a child's
potential.
And increasingly, professionals frown at the term: The special education journal
Mental Retardation this year changed its name to Intellectual & Developmental
Disabilities.
The editor said that ''mentally retarded'' is becoming passe and demeaning, much
like the terms idiot, imbecile and moron -- once used by doctors to describe
varying degrees of mental retardation.
In contrast, autism has become culturally acceptable -- and a ticket to a larger
range of school services and accommodations.
In 1990, Congress added the word ''autism'' as a separate disability category to
a federal law that guarantees special education services, and Education
Department regulations have included a separate definition of autism since 1992.
Before that, children with autism were counted under other disabling conditions,
such as mental retardation, said Jim Bradshaw, an education department
spokesman.
The Social Security Administration also broadened its definition of disability
to include spectrum disorders, like Asperger's.
Something else changed: The development of new stimulants and other medicines
may have encouraged doctors to make diagnoses with the idea of treating them
with these drugs.
Perception of the size of the problem changed, too.
Fourteen years ago, only 1 in 10,000 children were diagnosed with it. Prevalence
estimates gradually rose to the current government estimate of one in 150.
That increase has been mirrored in school districts. Gwinnett County Public
Schools -- Georgia's largest school system -- had eight classrooms for teaching
autistic youngsters 13 years ago; today there are 180.
Some researchers suggest that as autism spectrum diagnoses have gone up,
diagnoses of mild mental retardation have fallen.
U.S. Department of Education data show that the number of students with autism
rose steadily, from about 42,500 in 1997 to nearly 225,000 in 2006. Meanwhile,
the number of students counted as mentally retarded declined from about 603,000
to about 523,000.
CDC scientists believe education numbers are misleading, because they reflect
only how kids are categorized for services. They say there's no clear evidence
doctors are substituting one diagnosis for the other.
Some parents believe environmental factors -- ranging from a preservative in
vaccines to contaminants in food or water -- may be important contributors. (The
last doses of early childhood vaccines containing the preservative thimerosal
expired in 2002, although some children's flu shots still contain it.)
Dr. Gary Goldstein, scientific adviser to the national advocacy group Autism
Speaks, said the explanation for the rising autism prevalence is probably
complex. Labeling and diagnosing probably play a role, as do genetics, but he
believes the increase surpasses those two explanations.
''I'm seeing more children with autism than I ever would have expected to see,''
said Goldstein, who is chief executive of the Kennedy Krieger Institute, a
treatment center for pediatric developmental disabilities in Baltimore.
Autism Speaks budgets more than $4 million each year to research the causes of
autism, and about 90 percent of that has gone to genetics research. But
organization officials recently have been talking about changing that mix, and
spending as much as 50 percent of that money on potential environmental
triggers, Goldstein said.
Whether it's because of genes or the environment (or both), autism has hit the
Massey family hard. Chuck and Julia Massey, of Dacula, Ga., have three sons with
Asperger's.
The youngest, Ryan, was first diagnosed after he was slow to develop speaking
ability. His brothers -- Trevor, 14, and Morgan, 16 -- had learning and behavior
problems and were later diagnosed with Asperger's, too.
All got special education services and were treated with medications. Morgan has
improved, or matured, or both, and is now a social kid in mainstream classes at
a Gwinnett County high school. Trevor seems to be making the same transition,
his mother said.
Ryan is the most extreme. He still has uncontrollable tantrums and must attend
an Asperger's-only sixth-grade classroom that teaches social skills along with
traditional subjects.
In a recent interview at the family's home, Ryan acknowledged he still has anger
control issues. One of the three other students in his class is particularly
irritating. Ryan said the way he reacts is by ''grabbing his throat.''
But on this night, Ryan was calm. He described himself as happy, and paced the
room telling jokes, like a nervous stand-up comedian. (''Why didn't the skeleton
go to the party? He didn't have the guts,'' he said, eyes fixed on his
audience.)
Having three Asperger's boys under one roof has at times been very intense,
Massey said, noting a replaced dining room window.
Ryan acknowledged it's been educational living in a house full of Asperger's
kids. Asked to name something he's learned from his brothers, he replied,
''Swears.''
------
Centers for Disease Control and Prevention autism information:
http://www.cdc.gov/ncbddd/autism/
American Academy of Pediatrics autism reports:
http://www.aap.org/advocacy/releases/oct07autism.htm
Autism Epidemic May Be All in the Label, NYT, 4.11.2007,http://www.nytimes.com/aponline/us/AP-Autism-Epidemic.html
47
million Americans
lack health insurance: report
Thu Nov 1,
2007
4:36am EDT
Reuters
NEW YORK
(Reuters) - The number of Americans lacking health insurance rose by nearly 8.6
million to 47 million from 2000 to 2006, with children and workers from every
income level losing coverage, a new report said on Thursday.
The increase was "driven primarily by the continued erosion in employer-provided
health insurance," said the report by the Washington, D.C.-based Economic Policy
Institute.
In 2006, 2.3 million fewer Americans received health benefits from their
employers than in 2000, the report said, noting the decline does not take the
population increase into account.
Nearly 60 percent of the nation's children are covered by the insurance provided
by their parents' employers, but 3.4 million fewer children had benefits in 2006
compared with 2000.
"Public health insurance is no longer offsetting these losses," said the report
by the nonpartisan think-tank.
For jobholders, this was the sixth straight year of declines in health insurance
coverage. The rate fell to just below 71 percent from nearly 75 percent in 2000.
"No category of workers was insulated from loss of coverage," as even workers
whose earnings placed them in the top quintile saw coverage rates fall, the
report said.
More men lost employer-provided health benefits than women. For men, the rate
fell by almost 5 percentage points in the six-year period to 69 percent. For
women, the rate fell just under 3 percentage points to nearly 73 percent.
Native Americans had the highest rates of insurance coverage from employers at
almost 74 percent, though that was a drop of 3.5 percentage points. The rate for
people born in other countries just topped 54 percent in 2006, 4.4 percentage
points less than in 2000.
Whites had the highest rates of employer-provided health insurance, at 76.4
percent, though that was off 3.3 percentage points in the six-year period.
For blacks, the overall rate was nearly 66 percent, but off 2.6 percentage
points from 2000. Hispanics had only a 48.4 percent rate of coverage, down 5
percentage points.
White-collar workers saw their coverage rates fall 3.5 percentage points to 61.4
percent. The drop for blue-collar workers was steeper, down 5.6 percentage
points to 53.4 percent from 2000 to 2006.
The service sector's rate fell 5 percentage points -- and its employer-provided
coverage rate was much lower at just under 29 percent.
Among the states, only Hawaii saw an increase in the percentage of its
population under 65 years old who had employer-provided health insurance, up 0.5
percentage point to just over 71 percent in the survey period.
"The decline in employer coverage was pervasive and felt throughout the
country," the report said.
Thirty-eight states saw "significant" drops in benefits provided by employers
for people under 65, the report said. Utah, South Carolina, Maryland and Georgia
all saw rates drop by at least 7 percentage points.
Meanwhile, in California "nearly all of the losses in employment-based coverage
occurred among children," the report said, noting 600,000 fewer children had
such benefits in 2006 compared with 2000.
47 million Americans lack health insurance: report, R,
1.11.2007,
http://www.reuters.com/article/newsOne/idUSN3133728120071101
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