History > 2009 > USA > Health (VI)

Illustration: Brian Rea

Putting America on a Healthier Diet

NYT

12.9.2009

http://www.nytimes.com/2009/09/12/opinion/l12pollan.html

Swine Flu Spreading Widely;

Worry Over Pregnant Women

October 2, 2009
The New York Times
By DONALD G. MCNEIL Jr.

Swine flu is now widespread across the entire country, the Centers for Disease Control and Prevention announced Thursday as federal health officials released Tamiflu for children from the national stockpile and began taking orders from the states for the new swine flu vaccine.

Also, as anecdotal reports and at least one poll showed that many Americans are nervous about the vaccine, officials emphasized that the new shots were nearly identical to seasonal ones, and said they were doing what they could to debunk myths about the vaccine.

Dr. Anne Schuchat, the disease control center’s director of immunization and respiratory disease, said there was “significant flu activity in virtually all states,” which, she added, was “quite unusual for this time of year.”

Dr. Schuchat expressed particular worry about pregnant women. As of late August, 100 had been hospitalized in intensive care, and 28 had died since the beginning of the outbreak in April.

“These are really upsetting numbers,” she said, urging obstetricians and midwives to advise patients to get swine flu shots as soon as they become available.

Also on Thursday, a 23-year-old recruit in basic training in Fort Jackson, S.C., was acknowledged Thursday to be the Army’s first swine flu death. The recruit, Specialist Christopher M. Hogg of Deltona, Fla., fell ill on Sept. 1 and died of pneumonia on Sept. 10, the military said. Although Specialist Hogg initially tested negative for swine flu, it was found on autopsy.

About 50,000 troops a year train at Fort Jackson. (The camp was hit hard by the Spanish influenza in 1918, when up to 5 percent of the recruits died, according to a military historian quoted by The Associated Press.)

Flu cases are rising in many parts of the country, according to local news media reports.

Dell Children’s Medical Center in Austin, Tex., erected two tents in its parking lot to handle emergency room visits, and hospitals near Colorado Springs had a 30 percent spike in flu visits. Several North Carolina hospitals barred children from visiting.

Because pediatric cases are increasing, the Department of Health and Human Services on Tuesday released 300,000 courses of children’s liquid Tamiflu from the national pandemic stockpile, with the first batches going to Texas and Colorado.

Some was past its expiration date, Dr. Schuchat said, but the Food and Drug Administration tested the stocks and certified them as still usable.

More than 99 percent of all swine flu cases are mild to moderate, but millions of people with relatively common problems like asthma, obesity, diabetes or heart problems are at higher risk, as are pregnant women and infants too young for vaccine.

The last disease centers count of child deaths from the flu was 36 as of Aug. 8. Since then, there have been reports of children dying in several states, mostly in the South, where schools reopened earlier.

Last week, the centers reported that 936 Americans had died of flu symptoms or of flu-associated pneumonia since Aug. 30, when it began a new count of deaths including some without lab-confirmed swine flu. That is few compared with the 36,000 that die annually of seasonal flu, but the deaths are concentrated in age groups that do not normally succumb, and the regular flu season will not arrive until November.

Confirming the centers’ anxiety that many Americans are reluctant to get swine flu shots, Consumer Reports released a poll late Wednesday showing that half of all parents surveyed said they were worried about the flu, but only 35 percent would definitely have their children vaccinated. About half were undecided, and of those, many said they feared that the vaccine was new and untested.

One worrying aspect, said Dr. John Santa, the director of health ratings at Consumer Reports, was that 69 percent of parents who were undecided or opposed to shots said they “wanted their children to build up their natural immunity.”

“Your body produces exactly the same antibodies, whether it’s from a ‘natural’ infection or from a vaccine,” Dr. Santa said. “If your child is the one that dies, you’ve paid a very high price for ‘natural’ immunity.”

(The poll was a telephone survey of 1,502 adults from Sept. 2 to Sept. 7, with a margin of sampling error of plus or minus three percentage points.)

Dr. Schuchat argued that the vaccine was neither new nor untested.

It is attached to the same “genetic backbone” of weakened flu virus as the 100 million seasonal flu injections given each year, grown in the same sterile eggs and purified in the same factories. And test injections done in September found that it had the same side effects, most of which were sore arms and mild fevers.

Scientists at the disease centers also looked at lung samples from 77 fatal swine flu cases and found that in about a third of the cases, the patient had died not from flu alone, but from bacteria that infiltrate when flu inflames the lungs.

The “good news,” Dr. Schuchat said, is that most infections were streptococcus pneumoniae, a common bacteria for which there is a vaccine. That vaccine is normally given only to people over 65 or with chronic heart and lung problems, but only about one in five Americans eligible for that shot ever gets it. More people in those categories should, she said.

    Swine Flu Spreading Widely; Worry Over Pregnant Women, NYT, 2.9.2009,
    http://www.nytimes.com/2009/10/02/health/02flu.html

After a Death,

the Pain That Doesn’t Go Away

September 29, 2009
TH e New York Times
By FRAN SCHUMER

Each of the 2.5 million annual deaths in the United States directly affects four other people, on average. For most of these people, the suffering is finite — painful and lasting, of course, but not so disabling that 2 or 20 years later the person can barely get out of bed in the morning.

For some people, however — an estimated 15 percent of the bereaved population, or more than a million people a year — grieving becomes what Dr. M. Katherine Shear, a professor of psychiatry at Columbia, calls “a loop of suffering.” And these people, Dr. Shear added, can barely function. “It takes a person away from humanity,” she said of their suffering, “and has no redemptive value.”

This extreme form of grieving, called complicated grief or prolonged grief disorder, has attracted so much attention in recent years that it is one of only a handful of disorders under consideration for being added to the DSM-V, the American Psychiatric Association’s handbook for diagnosing mental disorders, due out in 2012.

Some experts argue that complicated grief should not be considered a separate condition, merely an aspect of existing disorders, like depression or post-traumatic stress. But others say the evidence is convincing.

“Of all the disorders I’ve heard proposed, they have better data for this than almost any of the other possible topics,” said Dr. Michael B. First, a professor of clinical psychiatry at Columbia and an editor of the current manual, DSM-IV. “It would be crazy of them not to take it seriously.”

There is no formal definition of complicated grief, but researchers describe it as an acute form persisting more than six months, at least six months after a death. Its chief symptom is a yearning for the loved one so intense that it strips a person of other desires. Life has no meaning; joy is out of bounds. Other symptoms include intrusive thoughts about death; uncontrollable bouts of sadness, guilt and other negative emotions; and a preoccupation with, or avoidance of, anything associated with the loss. Complicated grief has been linked to higher incidences of drinking, cancer and suicide attempts.

“Simply put,” Dr. Shear said, “complicated grief can wreck a person’s life.”

In 2004, Stephanie Muldberg of Short Hills, N.J., lost her son Eric, 13, to Ewing’s sarcoma, a bone cancer. Four years after Eric’s death, Ms. Muldberg, now 48, walked around like a zombie. “I felt guilty all the time, guilty about living,” she said. “I couldn’t walk into the deli because Eric couldn’t go there any longer. I couldn’t play golf because Eric couldn’t play golf. My life was a mess.

“And I couldn’t talk to my friends about it, because after a while they didn’t want to hear about it. ‘Stephanie, you need to get your life back,’ they’d say. But how could I? On birthdays, I’d shut the door and take the phone off the hook. Eric couldn’t have any more birthdays; why should I?”

Hours of therapy and support groups later, Ms. Muldberg was referred to a clinical trial at Columbia. After 16 weeks of a treatment developed by Dr. Shear, she was able to resume a more normal life. She learned to play bridge, went on a family vacation and read a book about something other than dying.

A crucial phase of the treatment, borrowed from the cognitive behavioral therapy used to treat victims of post-traumatic stress disorder, requires the patient to recall the death in detail while the therapist records the session. The patient must replay the tape at home, daily. The goal is to show that grief, like the tape, can be picked up or put away.

“I’d never been able to do that before, to put it away,” Ms. Muldberg said. “I was afraid I’d lose the memories, lose Eric.”

For some, the recounting is the hardest part of recovering. “That was just brutal and I had to relive it,” said Virginia Eskridge, 66, who began treatment 20 years after the death of her husband, Fred Adelman, a college professor in Pittsburgh. “I nearly dropped out, but I knew this was my last hope of getting any kind of functional life back.”

At the same time patients learn to handle their grief, they are encouraged to set new goals. For Ms. Eskridge, a retired law school librarian, that meant returning to the campus where her husband had taught.

“Everywhere I went there were reminders of him, because we had been everywhere,” she said. “It was like I was getting stabbed in the heart every time I went somewhere.”

That feeling finally went away, and Ms. Eskridge was even able to visit her husband’s old office. “It really gave me my life back,” she said of the treatment. “It sounds extreme, but it’s true.”

In a 2005 study in The Journal of the American Medical Association, Dr. Shear presented evidence that the treatment was twice as effective as the traditional interpersonal therapy used to treat depression or bereavement, and that it worked faster. The study supported earlier suggestions that complicated grief might actually be different not only from normal grief but also from other disorders like post-traumatic stress and major depression.

Then, in 2008, NeuroImage published a study of the brain activity of people with complicated grief. Using functional magnetic resonance imaging, Mary-Frances O’Connor, an assistant professor of psychiatry at the University of California, Los Angeles, showed that when patients with complicated grief looked at pictures of their loved ones, the nucleus accumbens — the part of the brain associated with rewards or longing — lighted up. It showed significantly less activity in people who experienced more normal patterns of grieving.

“It’s as if the brain were saying, ‘Yes I’m anticipating seeing this person’ and yet ‘I am not getting to see this person,’ ” Dr. O’Connor said. “The mismatch is very painful.”

The nucleus accumbens is associated with other kinds of longing — for alcohol and drugs — and is more dense in the neurotransmitter dopamine than in serotonin. That raises two interesting questions: Could memories of a loved one have addictive qualities in some people? And might there be a more effective treatment for this kind of suffering than the usual antidepressants, whose target is serotonin?

Experts who question whether complicated grief is a distinct disorder argue that more research is needed. “You can safely say that complicated grief is a disorder, a collection of symptoms that causes distress, which is the beginning of the definition of a disease,” said Dr. Paula J. Clayton, medical director of the American Foundation for Suicide Prevention. “However, other validators are needed: family history and studies that follow the course of a disorder. For example, once it’s cured, does it go away or show up years later as something else, like depression?”

George A. Bonanno, a professor of clinical psychology at Columbia known for his work on resilience (the reaction of the 85 percent of the population that does adapt to loss), was skeptical at first. But, Dr. Bonanno said, “I ran those tests and, lo and behold, extra grief symptoms were very important in predicting what was going on with these people, over and above depression and P.T.S.D.”

Regardless of how complicated grief is classified, the discussion highlights a larger issue: the need for a more nuanced look at bereavement. The DSM-IV devotes only one paragraph to the topic.

Studies suggest that therapy for bereavement in general is not very effective. But Dr. Bonanno called the published data “embarrassingly bad” and noted they tended to lump in results from “a lot of people who don’t need treatment” but sought it at the insistence of “loved ones or misguided professionals.”

Even if clinicians did identify people with complicated grief, there would not be enough therapists to treat them. Despite Dr. Shear’s “terrific research” on the therapy she pioneered, said Dr. Sidney Zisook, a professor of psychiatry at the University of California, San Diego, “there aren’t a lot of people out there who are trained to do it, and there aren’t a lot of patients with complicated grief who are benefiting from this treatment breakthrough.”

The issue is pressing given the links between complicated grief and a higher incidence of suicide, social problems and serious illness. “Do the symptoms of prolonged grief predict suicidality, a higher level of substance abuse, cigarette and alcohol consumption?” said Holly G. Prigerson, associate professor of psychiatry at Harvard Medical School and director of the Center for Psycho-oncology and Palliative Care Research at the Dana-Farber Cancer Institute in Boston. “Yes, yes and yes, over and above depression; they’re better predictors of those things.”

In an age when activities like compulsive shopping are viewed as disorders, the subject of grief is especially sensitive. Deeply bereaved people are often reluctant to talk about their sorrow, and when they do, they are insulted by the use of terms like disorder or addiction. Grief, after all, is noble — emblematic of the deep love between parents and children, spouses and even friends. Our sorrows, the poets tell us, make us human; would proper therapy have denied us Tennyson’s “In Memoriam”?

Diagnosing a deeper form of grief, however, is not about taking away anyone’s sorrow. “We don’t get rid of suffering in our treatment,” Dr. Shear said. “We just help people come to terms with it more quickly.”

“Personally, if it were me,” she added, “I would want that help.”

    After a Death, the Pain That Doesn’t Go Away, NYT, 29.9.2009, http://www.nytimes.com/2009/09/29/health/29grief.html

Job Losses,

Early Retirements

Hurt Social Security

September 28, 2009
Filed at 2:32 a.m. ET
By THE ASSOCIATED PRESS
The New York Times

WASHINGTON (AP) -- Big job losses and a spike in early retirement claims from laid-off seniors will force Social Security to pay out more in benefits than it collects in taxes the next two years, the first time that's happened since the 1980s.

The deficits -- $10 billion in 2010 and $9 billion in 2011 -- won't affect payments to retirees because Social Security has accumulated surpluses from previous years totaling $2.5 trillion. But they will add to the overall federal deficit.

Applications for retirement benefits are 23 percent higher than last year, while disability claims have risen by about 20 percent. Social Security officials had expected applications to increase from the growing number of baby boomers reaching retirement, but they didn't expect the increase to be so large.

What happened? The recession hit and many older workers suddenly found themselves laid off with no place to turn but Social Security.

''A lot of people who in better times would have continued working are opting to retire,'' said Alan J. Auerbach, an economics and law professor at the University of California, Berkeley. ''If they were younger, we would call them unemployed.''

Job losses are forcing more retirements even though an increasing number of older people want to keep working. Many can't afford to retire, especially after the financial collapse demolished their nest eggs.

Some have no choice.

Marylyn Kish turns 62 in December, making her eligible for early benefits. She wants to put off applying for Social Security until she is at least 67 because the longer you wait, the larger your monthly check.

But she first needs to find a job.

Kish lives in tiny Concord Township in Lake County, Ohio, northeast of Cleveland. The region, like many others, has been hit hard by the recession.

She was laid off about a year ago from her job as an office manager at an employment agency and now spends hours each morning scouring job sites on the Internet. Neither she nor her husband, Raymond, has health insurance.

''I want to work,'' she said. ''I have a brain and I want to use it.''

Kish is far from alone. The share of U.S. residents in their 60s either working or looking for work has climbed steadily since the mid-1990s, according to data from the Bureau of Labor Statistics. This year, more than 55 percent of people age 60 to 64 are still in the labor force, compared with about 46 percent a decade ago.

Kish said her husband already gets early benefits. She will have to apply, too, if she doesn't soon find a job.

''We won't starve,'' she said. ''But I want more than that. I want to be able to do more than just pay my bills.''

Nearly 2.2 million people applied for Social Security retirement benefits from start of the budget year in October through July, compared with just under 1.8 million in the same period last year.

The increase in early retirements is hurting Social Security's short-term finances, already strained from the loss of 6.9 million U.S. jobs. Social Security is funded through payroll taxes, which are down because of so many lost jobs.

The Congressional Budget Office is projecting that Social Security will pay out more in benefits than it collects in taxes next year and in 2011, a first since the early 1980s, when Congress last overhauled Social Security.

Social Security is projected to start generating surpluses again in 2012 before permanently returning to deficits in 2016 unless Congress acts again to shore up the program. Without a new fix, the $2.5 trillion in Social Security's trust funds will be exhausted in 2037. Those funds have actually been spent over the years on other government programs. They are now represented by government bonds, or IOUs, that will have to be repaid as Social Security draws down its trust fund.

President Barack Obama has said he would like to tackle Social Security next year.

''The thing to keep in mind is that it's unlikely we are going to pull out (of the recession) with a strong recovery,'' said Kent Smetters, an associate professor at the University of Pennsylvania's Wharton School. ''These deficits may last longer than a year or two.''

About 43 million retirees and their dependents receive Social Security benefits. An additional 9.5 million receive disability benefits. The average monthly benefit for retirees is $1,100 while the average disability benefit is about $920.

The recession is also fueling applications for disability benefits, said Stephen C. Goss, the Social Security Administration's chief actuary. In a typical year, about 2.5 million people apply for disability benefits, including Supplemental Security Income. Applications are on pace to reach 3 million in the budget year that ends this month and even more are expected next year, Goss said.

A lot of people who had been working despite their disabilities are applying for benefits after losing their jobs. ''When there's a bad recession and we lose 6 million jobs, people of all types are going to be part of that,'' Goss said.

Nancy Rhoades said she dreads applying for disability benefits because of her multiple sclerosis. Rhoades, who lives in Orange, Va., about 75 miles northwest of Richmond, said her illness is physically draining, but she takes pride in working and caring for herself.

In June, however, her hours were cut in half -- to just 10 a week -- at a community services organization. She lost her health benefits, though she is able to buy insurance through work, for about $530 a month.

''I've had to go into my retirement annuity for medical costs,'' she said.

Her husband, Wayne, turned 62 on Sunday, and has applied for early Social Security benefits. He still works part time.

Nancy Rhoades is just 56, so she won't be eligible for retirement benefits for six more years. She's pretty confident she would qualify for disability benefits, but would rather work.

''You don't think of things like this happening to you,'' she said. ''You want to be in a position to work until retirement, and even after retirement.''

------

On the Net:

Social Security retirement planner: http://www.ssa.gov/retire2/retirechart.htm

Congressional Budget Office: http://tinyurl.com/ydgrl5d

    Job Losses, Early Retirements Hurt Social Security, NYT, 28.9.2009, http://www.nytimes.com/aponline/2009/09/28/us/politics/AP-US-Social-Security-Early-Retirements.html

A Burst of Technology,

Helping the Blind to See

September 27, 2009
The New York Times
By PAM BELLUCK

Blindness first began creeping up on Barbara Campbell when she was a teenager, and by her late 30s, her eye disease had stolen what was left of her sight.

Reliant on a talking computer for reading and a cane for navigating New York City, where she lives and works, Ms. Campbell, now 56, would have been thrilled to see something. Anything.

Now, as part of a striking experiment, she can. So far, she can detect burners on her stove when making a grilled cheese, her mirror frame, and whether her computer monitor is on.

She is beginning an intensive three-year research project involving electrodes surgically implanted in her eye, a camera on the bridge of her nose and a video processor strapped to her waist.

The project, involving patients in the United States, Mexico and Europe, is part of a burst of recent research aimed at one of science’s most-sought-after holy grails: making the blind see.

Some of the 37 other participants further along in the project can differentiate plates from cups, tell grass from sidewalk, sort white socks from dark, distinguish doors and windows, identify large letters of the alphabet, and see where people are, albeit not details about them.

Linda Morfoot, 65, of Long Beach, Calif., blind for 12 years, says she can now toss a ball into a basketball hoop, follow her nine grandchildren as they run around her living room and “see where the preacher is” in church.

“For someone who’s been totally blind, this is really remarkable,” said Andrew P. Mariani, a program director at the National Eye Institute. “They’re able to get some sort of vision.”

Scientists involved in the project, the artificial retina, say they have plans to develop the technology to allow people to read, write and recognize faces.

Advances in technology, genetics, brain science and biology are making a goal that long seemed out of reach — restoring sight — more feasible.

“For a long time, scientists and clinicians were very conservative, but you have to at some point get out of the laboratory and focus on getting clinical trials in actual humans,” said Timothy J. Schoen, director of science and preclinical development for the Foundation Fighting Blindness. Now “there’s a real push,” he said, because “we’ve got a lot of blind people walking around, and we’ve got to try to help them.”

More than 3.3 million Americans 40 and over, or about one in 28, are blind or have vision so poor that even with glasses, medicine or surgery, everyday tasks are difficult, according to the National Eye Institute, a federal agency. That number is expected to double in the next 30 years. Worldwide, about 160 million people are similarly affected.

“With an aging population, it’s obviously going to be an increasing problem,” said Michael D. Oberdorfer, who runs the visual neuroscience program for the National Eye Institute, which finances several sight-restoration projects, including the artificial retina. Wide-ranging research is important, he said, because different methods could help different causes of blindness.

The approaches include gene therapy, which has produced improved vision in people who are blind from one rare congenital disease. Stem cell research is considered promising, although far from producing results, and other studies involve a light-responding protein and retinal transplants.

Others are implanting electrodes in monkeys’ brains to see if directly stimulating visual areas might allow even people with no eye function to see.

And recently, Sharron Kay Thornton, 60, from Smithdale, Miss., blinded by a skin condition, regained sight in one eye after doctors at the University of Miami Miller School of Medicine extracted a tooth (her eyetooth, actually), shaved it down and used it as a base for a plastic lens replacing her cornea.

It was the first time the procedure, modified osteo-odonto-keratoprosthesis, was performed in this country. The surgeon, Dr. Victor L. Perez, said it could help people with severely scarred corneas from chemical or combat injuries.

Other techniques focus on delaying blindness, including one involving a capsule implanted in the eye to release proteins that slow the decay of light-responding cells. And with BrainPort, a camera worn by a blind person captures images and transmits signals to electrodes slipped onto the tongue, causing tingling sensations that a person can learn to decipher as the location and movement of objects.

Ms. Campbell’s artificial retina works similarly, except it produces the sensation of sight, not tingling on the tongue. Developed by Dr. Mark S. Humayun, a retinal surgeon at the University of Southern California, it drew on cochlear implants for the deaf and is partly financed by a cochlear implant maker.

It is so far being used in people with retinitis pigmentosa, in which photoreceptor cells, which take in light, deteriorate.

Gerald J. Chader, chief scientific officer at the University of Southern California’s Doheny Retinal Institute, where Dr. Humayun works, said it should also work for severe cases of age-related macular degeneration, the major cause of vision loss in older people.

With the artificial retina, a sheet of electrodes is implanted in the eye. The person wears glasses with a tiny camera, which captures images that the belt-pack video processor translates into patterns of light and dark, like the “pixelized image we see on a stadium scoreboard,” said Jessy D. Dorn, a research scientist at Second Sight Medical Products, which produces the device, collaborating with the Department of Energy. (Other research teams are developing similar devices.)

The video processor directs each electrode to transmit signals representing an object’s contours, brightness and contrast, which pulse along optic neurons into the brain.

Currently, “it’s a very crude image,” Dr. Dorn said, because the implant has only 60 electrodes; many people see flashes or patches of light.

Brian Mech, Second Sight’s vice president for business development, said the company was seeking federal approval to market the 60-electrode version, which would cost up to $100,000 and might be covered by insurance. Also planned are 200- and 1,000-electrode versions; the higher number might provide enough resolution for reading. (Dr. Mech said a maximum electrode number would eventually be reached because if they are packed too densely, retinal tissue could be burned.)

“Every subject has received some sort of visual input,” he said. “There are people who aren’t extremely impressed with the results, and other people who are.” Second Sight is studying what affects results, including whether practice or disease characteristics influence the brain’s ability to relearn how to process visual signals.

People choose when to use the device by turning their camera on. Dean Lloyd, 68, a Palo Alto, Calif., lawyer, was “pretty disappointed” when he started in 2007, but since his implant was adjusted so more electrodes responded, is “a lot more excited about it,” he said. He uses it constantly, seeing “borders and boundaries” and flashes from highly reflective objects, like glass, water or eyes.

With Ms. Morfoot’s earlier 16-electrode version, which registers objects as horizontal lines, she climbed the Eiffel Tower and “could see all the lights of the city,” she said. “I can see my hand when I’m writing. At Little League games, I can see where the catcher, batter and umpire are.”

Kathy Blake, 58, of Fountain Valley, Calif., said she mainly wanted to help advance research. But she uses it to sort laundry, notice cars and people, and on the Fourth of July, to “see all the fireworks,” she said.

Ms. Campbell, a vocational rehabilitation counselor for New York’s Commission for the Blind and Visually Handicapped, has long been cheerfully self-sufficient, traveling widely from her fourth-floor walk-up, going to the theater, babysitting for her niece in North Carolina.

But little things rankle, like not knowing if clothes are stained and needing help shopping for greeting cards. Everything is a “gray haze — like being in a cloud,” she said. The device will not make her “see like I used to see,” she said. “But it’s going to be more than what I have. It’s not just for me — it’s for so many other people that will follow me.”

Ms. Campbell’s “realistic view of her vision” and willingness to practice are a plus, said Aries Arditi, senior fellow in vision science at Lighthouse International, a nonprofit agency overseeing her weekly training, which includes practice moving her head so the camera captures images and interpreting light as objects.

“In 20 years, people will think it’s primitive, like the difference between a Model T and a Ferrari,” said Dr. Lucian Del Priore, an ophthalmology surgeon at New York-Presbyterian Hospital/Columbia University Medical Center, who implanted Ms. Campbell’s electrodes. “But the fact is, the Model T came first.”

Ms. Campbell would especially like to see colors, but, for now, any color would be random flashes, Dr. Arditi said.

But she saw circular lights at a restaurant, part of a light installation at an art exhibition. “There’s a lot to learn,” she said. Still, “I’m, like, really seeing this.”

    A Burst of Technology, Helping the Blind to See, NYT, 27.9.2009, http://www.nytimes.com/2009/09/27/health/research/27eye.html

Atlanta Judge Rules

Dialysis Unit Can Be Closed

September 26, 2009
The New York Times
By KEVIN SACK

ATLANTA — Uninsured dialysis patients who could be cut off from their life-sustaining care lost a court challenge on Friday when a judge ruled that Grady Memorial Hospital could close its outpatient dialysis clinic. But the hospital gave the patients a temporary reprieve.

Ruling largely on technical grounds, a state court judge dissolved the restraining order that prevented last weekend’s scheduled closing of the clinic at Grady, the Atlanta region’s safety net hospital. The hospital, which is deeply in debt, quickly announced it would close the clinic within a week. It agreed, however, to pay for up to three months of dialysis at private clinics for the 51 patients who will be dislocated.

Grady will continue to assist the indigent patients, many of them illegal immigrants, in seeking care in their home countries or in other states where they may qualify for emergency Medicaid coverage.

Lawyers and advocates for the Grady dialysis patients had asked in negotiating sessions that the hospital provide a longer transition period. Grady’s senior vice president, Matt Gove, said he could not speculate about whether the hospital would extend its financial assistance beyond three months to patients unable to make arrangements.

“The hospital, along with the patient, each bears some responsibility in doing everything we can to find a long-term solution,” Mr. Gove said.

Federal law generally prohibits coverage of illegal immigrants by Medicaid and Medicare (which pays for dialysis for citizens regardless of age). Some states — but not Georgia — allow those immigrants to use Medicaid dollars in emergency situations, potentially including dialysis. Legal immigrants must wait five years before qualifying for benefits.

In the Atlanta region, that has made Grady, which accepts all patients regardless of immigration status or ability to pay, the provider of last resort for many illegal and uninsured patients. The taxpayer-supported hospital estimates the dialysis clinic will lose $2 million this year. Mr. Gove said he could not project how much the three-month extension might cost.

Lindsay R. Jones, the lawyer for the patients, called the order Friday by Judge Ural D. Glanville of Fulton County Superior Court “an angry, punitive decision.”

“At least 51 patients had their life support system unplugged today under the authorization of this judge,” Mr. Jones said.

He said he planned to refile his case in Judge Glanville’s court on Monday after addressing its technical problems. He said he hoped to persuade the judge to hear the stories of some of the dialysis patients who accompanied him to a hearing on Wednesday but were not allowed to testify.

Mr. Jones said he did not expect a markedly different result, but hoped to create a record that might be used in a federal court filing that he was considering.

Judge Glanville ruled that Mr. Jones’s class-action complaint had been improperly filed because, among other reasons, it lacked signatures from the two patients listed as plaintiffs. But the judge went further by writing that even if the case had been properly filed it would be unlikely to succeed on the merits.

“As it relates to the receipt of medical treatment, the court is unpersuaded at this time that plaintiffs have a constitutional right to the sought-after relief,” Judge Glanville wrote.

    Atlanta Judge Rules Dialysis Unit Can Be Closed, NYT, 27.9.2009, http://www.nytimes.com/2009/09/26/health/policy/26grady.html

For First Time,

AIDS Vaccine Shows Some Success

September 25, 2009
The New York Times
By DONALD G. McNEIL Jr.

Scientists said Thursday that a new AIDS vaccine, the first ever declared to protect a significant minority of humans against the disease, would be studied to answer two fundamental questions: why it worked in some people but not in others, and why those infected despite vaccination got no benefit at all.

The vaccine — known as RV 144, a combination of two genetically engineered vaccines, neither of which had worked before in humans — was declared a qualified success after a six-year clinical trial on more than 16,000 volunteers in Thailand. Those who were vaccinated became infected at a rate nearly one-third lower than the others, the sponsors said Thursday morning.

“I don’t want to use a word like ‘breakthrough,’ but I don’t think there’s any doubt that this is a very important result,” said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, which is one of the trial’s backers.

“For more than 20 years now, vaccine trials have essentially been failures,” Dr. Fauci said. “Now it’s like we were groping down an unlit path, and a door has been opened. We can start asking some very important questions.”

It will still, however, take years of work before a vaccine that could end the epidemic, which has killed about 25 million people, can even be contemplated.

“We often talk about whether a vaccine is even possible,” said Mitchell Warren, the executive director of the AIDS Vaccine Advocacy Coalition, or AVAC. “This is not the vaccine that ends the epidemic and says, ‘O.K., let’s move on to something else.’ But it’s a fabulous new step that takes us in a new direction.”

In which direction is still unknown. No one — including the researchers from the United States Army, the National Institutes of Health, the Thai Ministry of Public Health and two vaccine companies that tested the vaccine — knows why the vaccine gave even its weak indicator of success.

Experts generally disdain vaccines that do not protect at least 70 to 80 percent of those getting them. And this vaccine did not lower the viral loads of people who were vaccinated but caught the virus anyway, which was baffling because even mismatched vaccines usually do that.

Simply repeating the trial to confirm the results would be pointless, experts agreed.

The trial, the largest AIDS vaccine trial in history, cost $105 million and followed 16,402 Thai volunteers.

The men and women ages 18 to 30 were recruited from two provinces southeast of the capital, Bangkok, from the general population rather than from high-risk groups like drug injectors or sex workers. Half got six doses of two different vaccines; half were given placebos.

For ethical reasons, all were offered condoms, taught how to avoid infection and promised lifelong antiretroviral treatment if they got AIDS. They were then regularly tested for three years; 74 of those who got placebos became infected, but only 51 of those who got the vaccines did.

Although the difference was a mere 23 people, Col. Jerome H. Kim, a physician and the manager of the Army’s H.I.V. vaccine program, said it was statistically significant and meant that the vaccine was 31.2 percent effective.

The results were surprising because both vaccines, one from the French company Sanofi-Aventis and one developed by Genentech but now licensed to Global Solutions for Infectious Diseases, a nonprofit health group, had failed when used individually.

“This came out of the blue,” said Chris Viehbacher, Sanofi’s chief executive. Even 31 percent protection “was at least twice as good as our own internal experts were predicting,” he added.

In 2004, there was so much skepticism about the trial just after it began that 22 top AIDS researchers published an editorial in Science magazine suggesting that it was a waste of money.

One conclusion from the surprising result, said Alan Bernstein, head of the Global HIV Vaccine Enterprise, an alliance of organizations pursuing a vaccine, “is that we’re not doing enough work in humans.”

Instead of going back to mice or monkeys, he said, different new variants on the two vaccines could be tried on a few hundred people in several countries.

This vaccine was designed to combat the most common strain of the virus in Southeast Asia, so it would have to be modified for the strains circulating in Africa and the United States.

Sanofi’s vaccine, Alvac-HIV, is a canarypox virus with three AIDS virus genes grafted onto it. Variations of it were tested in several countries; it was safe but not protective. The other vaccine, Aidsvax, was originally made by Genentech and contains a protein found on the surface of the AIDS virus; it is grown in a broth of hamster ovary cells. It was tested in Thai drug users in 2003 and in gay men in North America and Europe but failed.

In 2007, two trials of a Merck vaccine in about 4,000 people were stopped early; it not only failed to work but for some men also seemed to increase the risk of infection.

Combining Alvac and Aidsvax was simply a hunch: if one was designed to create antibodies and the other to alert white blood cells, might they work together?

One puzzling result — those who became infected had as much virus in their blood whether they got the vaccine or a placebo — suggests that RV 144 does not produce neutralizing antibodies, as most vaccines do, Dr. Fauci said. Antibodies are Y-shaped proteins formed by the body that clump onto invading viruses, blocking the surface spikes with which they attach to cells and flagging them for destruction.

Instead, he theorized, it might produce “binding antibodies,” which latch onto and empower effector cells, a type of white blood cell attacking the virus. Therefore, he said, it might make sense to screen all the stored Thai blood samples for binding antibodies.

“The humbling prospect of this,” he said, “is that we may not even be measuring the critical parameter. It may be something you don’t normally associate with protection.”

Dr. Lawrence Corey, the principal investigator for the HIV Vaccine Trials Network, who was not part of the RV 144 trial, said new work on weakened versions of the smallpox vaccine had produced better pox “spines” that could be substituted for the canarypox. New trials, he added, could be faster and smaller if they were done in African countries where AIDS is more common than in Thailand.

    For First Time, AIDS Vaccine Shows Some Success, NYT, 25.9.2009, http://www.nytimes.com/2009/09/25/health/research/25aids.html

Immigrants Cling to Fragile Lifeline

at Safety-Net Hospital

September 24, 2009
The New York Times
By KEVIN SACK

ATLANTA — If Grady Memorial Hospital succeeds in closing its outpatient dialysis clinic, Tadesse A. Amdago, a 69-year-old immigrant from Ethiopia, said he would begin “counting the days until I die.” Rosa Lira, 78, a permanent resident from Mexico, said she also assumed she “would just die.” Another woman, a 32-year-old illegal immigrant from Honduras, said she could only hope to make it “back to my country to die.”

The patients, who have relied for years on Grady’s free provision of dialysis to people without means, said they had no other options to obtain the care that is essential to their survival. But the safety-net hospital, after years of failed efforts to drain its red ink, is not backing away from what its chairman, A. D. Correll, calls a “gut-wrenching decision”: closing the clinic this month.

The sides confronted each other in state court on Wednesday morning as lawyers for the patients sought to keep the clinic open until other arrangements for dialysis could be secured. Dialysis patients and their families packed the benches and 60-year-old Nelson Tabares, a seriously ill illegal immigrant from Honduras, was wheeled into court in a portable bed.

Despite a judge’s urging that the two sides negotiate a solution Wednesday, there was no agreement by the end of the day on how to go forward. For the time being, a restraining order keeping the clinic open stands. The judge is considering whether to extend it.

The dialysis unit on Grady’s ninth floor might as well be ground zero for the national health care debate. It is there that many of the ills afflicting American health care intersect: the struggle of the uninsured, the strain of providing uncompensated care, the inadequacy of government support, and the dilemma posed by treating illegal immigrants.

Grady is one of many public hospitals that have been battered by the recession as the number of uninsured has mounted. New York City’s public hospital system is eliminating 400 positions and closing some children’s mental health programs, pharmacies and clinics. University Medical Center in Las Vegas has closed its mammography center and outpatient oncology clinic.

“It comes down to which service do you need to keep open,” said Larry S. Gage, president of the National Association of Public Hospitals. “You try your hardest to cut back on services that are going to be available elsewhere in the community.”

Public hospital officials are concerned that the health care legislation being negotiated in Washington could worsen their plight before making it better. Under bills traveling through both houses of Congress, as the number of uninsured declines there would be commensurate reductions in Medicaid subsidies to hospitals that provide large amounts of uncompensated care.

At Grady, about four in 10 patients are uninsured, and an additional 25 percent are insured by Medicaid, which reimburses at rates so low they often do not cover actual costs. As a result, the hospital lost $33.5 million last year, with the dialysis clinic accounting for about $2 million of that total, said Denise R. Williams, the hospital’s executive vice president.

Nonetheless, as a taxpayer-supported hospital with the mission of serving the indigent, Grady is expected to take all comers in need of emergency care, like dialysis. Treatment there does not depend on a patient’s insurance or immigration status.

The hospital has been encouraging some of the dialysis patients to move to other states or back to their home countries, offering to defray some costs.

Hospital officials estimate that two-thirds of the outpatient clinic’s roughly 90 patients are illegal immigrants. They do not qualify for Medicare, which covers dialysis regardless of a patient’s age, and they are excluded in Georgia from Medicaid and other government insurance programs. Legal immigrants face a five-year waiting period before becoming eligible. That leaves Grady to absorb costs of up to $50,000 a year per dialysis patient, some of whom have availed themselves of the thrice-weekly treatments for years.

After years of fiscal desperation and management turmoil at Grady, Atlanta business leaders stepped in last year to force a restructuring, from a quasi-governmental authority to a nonprofit corporate board. In response, the Robert W. Woodruff Foundation pledged $200 million over four years to replace dilapidated beds and modernize computers. A $20 million gift from Bernie Marcus, a founder of Home Depot, is helping to update the emergency department, which provides regional trauma services.

But the hospital’s operating deficits have continued. Grady’s senior vice president, Matt Gove, estimated that its uncompensated care would grow by $50 million this year, up 25 percent. The new nonprofit board eliminated 150 jobs this year, closed an underused primary care clinic and began charging higher fees to patients who live outside of the two counties that support Grady with direct appropriations.

The closing of the outpatient dialysis clinic was recommended by consultants in 2007, who said that equipment was outmoded, that most hospitals did not provide outpatient dialysis and that Atlanta had scores of commercial dialysis centers. When the hospital’s chief executive at the time tried to shut it down, the resulting firestorm helped prompt his dismissal.

This July, the new board voted to try again. The hospital gave patients a month’s notice of the scheduled Sept. 19 closing, and vowed to assist them in finding local dialysis providers, relocating elsewhere and qualifying for public insurance. “We committed that not a single person would be left behind,” Mr. Correll wrote in a newspaper advertisement published on Sunday.

About a third of the patients have been successfully moved, including several illegal immigrants who returned to Mexico with the hospital’s financial help, Mr. Gove said. But others have said they have no place to go, have no means to pay for dialysis or are too ill to travel.

The female illegal immigrant from Honduras, who has a 7-year-old son, said her parents live more than a four-hour drive from the nearest dialysis center, in Tegucigalpa. She is mindful that her sister died from a stroke while being driven to a hospital there. She said she had no money to pay for dialysis because she was too weary from her kidney condition to hold down a job.

“I feel like they are trying to get rid of me because I don’t work,” she said, her eyes tearing. “But being sick is not my fault.”

Samuel Tabares, who rolled his father into court in his bed, said his father, who was paralyzed by a stroke, would probably not survive the strain of relocation or repeated trips to the emergency room in search of treatment.

“They’re treating the closing of this clinic like it’s the closing of a dental clinic,” Mr. Tabares said, “as if people’s lives don’t depend on it.”

    Immigrants Cling to Fragile Lifeline at Safety-Net Hospital, NYT, 24.9.2009, http://www.nytimes.com/2009/09/24/health/policy/24grady.html

Forty Years' War

Where Cancer Progress Is Rare,

One Man Says No

September 16, 2009
The New York Times
By GARDINER HARRIS

Politicians and researchers have predicted for nearly four decades that a cure for cancer is near, but cancer death rates have hardly budged and most new cancer drugs cost a fortune while giving patients few, if any, added weeks of life. For this collective failure, the man atop the nation’s regulatory agency for new cancer drugs increasingly — and supporters say unfairly — gets the blame: Dr. Richard Pazdur.

Patient advocates have called Dr. Pazdur, director of the Food and Drug Administration’s cancer drug office, a murderer, conservative pundits have vilified him as an obstructionist bureaucrat, and guards are now posted at the agency’s public cancer advisory meetings to protect him and other committee members.

“The industry is not producing that many good drugs, so now they’re looking for scapegoats in Rick Pazdur and the F.D.A.,” said Ira S. Loss, who follows the drug industry for Washington Analysis, a service for investors.

In 10 years at the Food and Drug Administration, Dr. Pazdur, 57, has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial, a requirement that he repeated at a public advisory hearing on Sept. 1 in the slow, loud tones of someone disciplining a dog. After he spoke, the committee of experts voted to reject both drugs.

Critics say that Dr. Pazdur’s resolve has cost thousands of lives and set back the pace of discoveries.

“Patients are right to be angry and frustrated with Richard Pazdur,” said Steven Walker, co-founder of the Abigail Alliance, a patient advocacy group. “He is a dinosaur.”

But neither the controversies swirling about him nor his years as an oncologist treating terminal patients have dented Dr. Pazdur’s naturally sunny disposition. He laughs like Charles Nelson Reilly, eats like Gandhi and likens his tenure at the drug administration to that of a Roman Catholic priest from the 1960s who had to translate the Latin liturgy into plain language.

“You can’t win in this job,” Dr. Pazdur said in an interview in his office. “If you approve a drug, they accuse you of lowering standards. And if you don’t approve it, you’re the worst thing since the Nazi death camps and should be killed.”

Whether Dr. Pazdur has struck the right balance between hope and certainty has enormous consequences for patients and industry. Cancer is the second-leading cause of death in the United States; more than 562,000 people are expected to die of it this year.

Pharmaceutical and biotechnology companies are testing more than 860 new cancer medicines — more than in any other disease category, according to manufacturers. Because patients are desperate and insurers are often forced by law to pay, prices are soaring, making cancer medicines among the best ways for drug makers to make money. But cancer has proven difficult to crack, leading to frustration among executives and advocates who wonder why the Food and Drug Administration is not approving more drugs.

No cancer medicines can be sold to or even tested on people without the imprimatur of Dr. Pazdur and his staff of about 150 oncologists, toxicologists and other specialists. But pressure from advocacy groups and cancer researchers frustrated with failure have led the agency to abandon many of the usual approval requirements.

Federal law requires that the agency demand two “well controlled” trials before approving a drug; in cancer, the Food and Drug Administration is often satisfied with just one. With many experimental drugs, the agency demands trials with thousands of patients, while for cancer, it has accepted studies with a few dozen.

Before Dr. Pazdur’s arrival, the agency largely insisted that drug makers prove that their products extended life. Companies did this by giving the drug to one group of patients, providing a placebo or an older drug to another group and then seeing which group lived longer. But some cancers take a long time to kill, making survival trials lengthy and expensive.

So the drug administration under Dr. Pazdur’s leadership increasingly allowed some studies to track a drug’s effect with X-rays. If scans showed that tumors grew less rapidly, the drug could be approved.

Dr. Pazdur pressed for the changes because, he said, the growing number of approved cancer medicines made determining whether any one delayed death increasingly difficult. Many patients now cycle through several medicines before dying. And some drugs that have not been proven to extend life may delay more serious symptoms and medical interventions, he said.

For instance, the drug administration initially rejected oxaliplatin because no trial at the time proved that it delayed death. But the agency finally relented in 2002 — years after the drug’s approval in Europe — because scans showed that it postponed tumor growth. Oxaliplatin is now commonly used to combat colorectal cancer.

 

Criticizing Changes

Some patient advocates — mostly from older, more established organizations — bemoan these changes because even if a drug shrinks tumors, it may do nothing to delay death or improve patients’ last days. And because so many cancer medicines have toxic side effects and high prices, drugs that have no proven benefit may actually be harmful to patients’ health and economic well-being.

These advocates point to mistakes like toxic chemotherapy with bone marrow transplants in breast cancer, which in the 1980s and 1990s increased the suffering of nearly 30,000 women before studies finally showed that it was ineffective. When in doubt, the drug administration should not approve, they say.

“We want drugs that prolong survival, not drugs that just improve a test result,” said Frances M. Visco, president of the National Breast Cancer Coalition.

To others — mostly newer, more aggressive patient organizations — the F.D.A.’s cancer group under Dr. Pazdur’s leadership has not lowered standards or sped approvals nearly enough. If there is any hint that a drug works, dying patients — many of whom have run out of other options — should be allowed to buy them, they said.

And some cancer specialists say that Dr. Pazdur, after pushing for years to lower approval standards, has toughened them recently after being criticized for approving drugs that were later shown to have few benefits.

“I’m worried there’s been a change in his thinking that could be adverse for the field,” said Dr. Bruce A. Chabner, clinical director of the Massachusetts General Hospital Cancer Center and a member of the board of directors of PharmaMar, a Spanish biotech company whose drug Yondelis is approved in Europe but was rejected in July by the F.D.A.’s cancer advisory board after a critical introduction by Dr. Pazdur.

Little of this controversy surrounding Dr. Pazdur affects the development of truly powerful medicines. In 2001, his agency took just 11 weeks to approve Gleevec, which has miraculous effects on a form of leukemia. But when drugs have marginal benefits, figuring out whether they work is controversial and time consuming.

 

Taking a Drug to the F.D.A.

Many of the recent rejects have come from small biotechnology companies for which a single F.D.A. approval can be the difference between fiscal calamity and vast profits. On Sept. 1, tiny Vion Pharmaceuticals took its leukemia drug Onrigin to a Food and Drug Administration advisory committee for consideration.

One clinical trial found that Onrigin increased deaths threefold compared with a placebo. The drug administration told the company in meetings in 2004 and 2006 that another trial was so poorly designed that it was unlikely to pass muster. Vion persisted.

During the company’s presentation to the advisory committee, Dr. Pazdur seemed at times visibly pained — grimacing or shaking his head. When patients taken to the meeting by Vion spoke about Onrigin’s benefits, he turned away. (“Only patients who benefit from the drugs are brought to the meetings, not those who are harmed or get nothing,” he explained later.) He reminded the committee, “We only have one randomized trial here which shows an increase in death.”

The committee voted 13 to 0 to require a new study. Vion executives would not comment.

Some small companies seeking approval of a drug have waged public campaigns with the help of investors and advocacy groups that sometimes lead to vicious attacks on Dr. Pazdur. Take the case of Xcytrin, a brain cancer medicine made by Pharmacyclics of Sunnyvale, Calif. After a critical study failed to show that the drug worked, the company’s chief executive at the time, Dr. Richard Miller, blamed doctors at a hospital in France.

“They got a very negative result there, and it really skewed the data,” Dr. Miller said in an interview.

He lobbied top F.D.A. officials to approve the drug anyway. They refused. He became a prominent agency critic, writing four opinion columns in The Wall Street Journal in 2007 arguing that the agency was keeping vital treatments from dying patients.

Dr. Miller did not make public the drug agency’s reasons for rejecting Xcytrin and, because the law prevents the agency from discussing drug rejections, Dr. Pazdur remained mum.

A year ago, Dr. Miller was replaced as chief executive at Pharmacyclics by Robert W. Duggan. In an interview, Mr. Duggan said that the Xcytrin study was flawed and that the drug administration was right to reject the drug.

“It’s not just one hospital mishandling the data — that’s false,” said Mr. Duggan, who described the trial’s results as a “dog’s breakfast” of confusing signals. Biotech executives often blame the drug administration for their own failures so they can continue to raise money from investors, Mr. Duggan said.

Dr. Miller, who is raising money for a new company, responded, “I think Mr. Duggan is making nice to the F.D.A.”

Tony Fiorino, president and chief executive of EnzymeRx, in Paramus, N.J., said that biotech executives were often former scientists who believed so deeply in their products that “it’s an ecstatic experience.” When the drug administration rejects their application, these executives have every incentive, he said, to “go ballistic on the agency.”

“You’re going to pull out all the stops,” Mr. Fiorino said. “This is your one lottery ticket.”

And it is not just executives behind the attacks. Melvin Flores, an oxygen technician from Lowell, Ark., sent several e-mail messages last year to Dr. Pazdur, one of which said, “You’ve murdered enough innocent people already — enough is enough.”

Mr. Flores invested in a company whose cancer medicine did not get approved, pummeling its shares and depriving patients of a lifesaver, he said in an interview. “It’s a Holocaust that has happened,” he said.

Besides singling out Dr. Pazdur’s e-mail box, advocates have put his name on advertisements on city buses in the Washington area, sued him and shouted his name at protests. But Dr. Pazdur said he and his family had endured far worse.

 

In Perspective

His grandfather, a Polish immigrant, was crushed to death under a railroad car in the Great Depression while sweeping up loose corn kernels to feed his family. With six children, his grandmother remarried, had three more kids and was widowed again several years later when her second husband died in a construction accident.

His mother married her first husband two weeks before he shipped out for World War II; he was killed in the war. Dr. Pazdur’s father, a factory worker for Standard Oil of Indiana, went blind from glaucoma when Dr. Pazdur was a young teenager, impoverishing his family anew.

An avid gym cyclist who is greyhound thin, Dr. Pazdur does not eat meat because he believes that a vegetarian diet will help protect him from cancer, although the supporting evidence is as thin as vegetable broth. His wife, Mary, said that when he travels, she buys herself a nice steak.

Dr. Pazdur became intrigued with the Food and Drug Administration while overseeing drug trials at the University of Texas M. D. Anderson Cancer Center. When the cancer job became available, he applied. On his first day, he was struck by how much the agency resembled the Catholic Church of his childhood.

“We had a door in our old office that was controlled electronically, so someone had to buzz you in,” Dr. Pazdur said. “We had that same door in my grade school separating the convent from the school. It was such a secretive world here.”

He set about changing that by reaching out to cancer advocacy and medical groups. He has held cancer advisory meetings at the annual meeting of the American Society of Clinical Oncology, the world’s largest body of cancer scientists. And he began, in conjunction with others, an annual training program for cancer researchers.

The result is that Dr. Pazdur “has a lot of support within the mainstream cancer community,” said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society. In May, the oncologists’ society gave him a special recognition award for “his outstanding service to the oncology community.”

Dr. Pazdur said that blaming the Food and Drug Administration for the dearth of new cancer medicines was “like blaming the failures of American education on the SAT test.”

“We just do the assessments,” he said.

    Where Cancer Progress Is Rare, One Man Says No, NYT, 16.9.2009, http://www.nytimes.com/2009/09/16/health/policy/16cancer.html

Slain Abortion Opponent

‘Loved the Controversy’

His Protests Generated

September 14, 2009
The New York Times
By MARY M. CHAPMAN

OWOSSO, Mich. — For at least two decades, in weather good or bad, James Pouillon would stand for hours at a time around this small, rural town, waving graphic signs and breaking the idyllic quiet with loud anti-abortion rants.

That is how most residents of Owosso, just outside Flint, said they would remember Mr. Pouillon, a retired auto worker who was shot to death on Friday morning while staging a protest here. Others, though, knew him as a good neighbor and devoted family man who loved to romp with his grandchildren in his backyard.

On the day he died, Mr. Pouillon, 63, was in front of Owosso High School doing what he did just about every day, demonstrating and carrying a placard bearing the word “Life” on one side and an image of an aborted fetus with the word “Abortion” on the other.

Mr. Pouillon’s death is believed to be the first killing of a person protesting abortion. And it even caught the attention of President Obama, who on Sunday called the shooting “deplorable” in a statement. “Whichever side of a public debate you’re on,” he said, “violence is never the right answer.”

An Owosso truck driver, Harlan J. Drake, has been charged in Mr. Pouillon’s killing and that of a local businessman, Mike Fuoss. Sara Edwards, the Shiawasee County chief assistant prosecutor, said the suspect was annoyed by Mr. Pouillon’s protests, especially when they were near schools.

Mr. Pouillon’s nephew Steven Pouillon, 39, said in a telephone interview from his home in Owosso that his uncle was a family man “who took care of his own.” He said his uncle was in good spirits when he last saw him, at a high school football game on Sept. 4.

Although he said the two of them were not particularly close, Steven Pouillon remembers hunting and fishing trips together years ago. He said that Mr. Pouillon’s divorce more than a decade ago “triggered” an increase in his protest activities.

“He got heavy into it after that,” he said.

Mr. Pouillon was a frequent diner at Greg and Lou’s, a family restaurant in Owosso. He visited at least twice a week, mostly for breakfast. And he seemed like a normal guy to Amanda Lange, a waitress there.

“He never pushed that here,” Ms. Lange said of Mr. Pouillon’s views. “He was a very nice guy. He’d always ask about my family.”

But Tony Young, president of Young Chevrolet, saw another side of Mr. Pouillon, who sometimes protested outside his dealership. The protests were because Mr. Pouillon did not like a political candidate Mr. Young supported, Mr. Young said.

“He loved the attention, he loved the controversy,” Mr. Young said, “and he knew how to get your goat.”

Longtime residents said Mr. Pouillon grew up in Owosso and kept mostly to himself. He went to work at a Flint plant.

One of those residents, Jimmy Carmody, 54 also linked Mr. Pouillon’s protests to his divorce.

“I really don’t think he hated abortion as much as he was bitter about the marriage,” Mr. Carmody said, after shopping at the Farmer’s Market. Mr. Pouillon’s former wife, Mary Lou, died in a car accident in 2001, a family member said.

Last Saturday, “the Sign Man,” as many local residents called Mr. Pouillon, was pelted with fruit by a shopper with whom he was arguing while protesting near the market. “He’d stand over there with his signs and be cussing customers out,” Mr. Carmody said. “He became just too in-your-face.”

In the last year or so, Mr. Pouillon’s protests became increasingly erratic. “You could hear him sometimes making baby noises, or screaming something about Obama,” Mr. Carmody said.

Mr. Young said that after about three years of protesting outside his dealership, Mr. Pouillon came in and offered a truce. “ ‘Tony,’ ” Mr. Young said the exchange began, “if you would just agree that I’m right on my beliefs, I’ll stop.’

“I just told him, ‘Sure, Jim, you’re right,’ ” Mr. Young said, chuckling. After that, he said, Mr. Pouillon moved on.

Mr. Young said the last time he saw Mr. Pouillon was at the football game. In addition to places like City Hall, Mr. Pouillon liked to be where he thought he could influence young people, he said.

Ms. Edwards said Mr. Pouillon had been arrested before for his activities, although not in recent years. “He knew his boundaries,” she said. “He always was on the right of way. He knew where he could stand, basically.”

From most accounts, Mr. Pouillon was not particularly religious, although he did occasionally attend St. Paul’s Catholic Church in Owosso, residents said. He was active with area anti-abortion groups. A vigil was held for him Sunday not far from where he was shot, The Associated Press reported.

On Saturday, a handful of bouquets lay at the corner where Mr. Pouillon was killed.

The clean, expansive mobile home community where he lived is in a remote area of Owosso Township surrounded by cornfields and dotted with single-family, mostly aluminum-sided homes. A dirt-bike racing complex is nearby. The home where Mr. Pouillon lived is beige with maroon shutters that have heart shapes cut out of them. The lawn is well manicured, and flags adorn the outside doors. Two of Mr. Pouillon’s five adult children, his daughter Mary Jo, 26, and his son Lance, 24, lived with him.

Gary Herald, 33, a computer programmer and Mr. Pouillon’s next-door neighbor for the last nine years, said he had thought something bad might befall Mr. Pouillon because of his protesting.

“We used to talk casually as neighbors,” Mr. Herald said, “and one time a few years ago I told him I thought his signs were gross. He just shrugged and told me those were his beliefs.”

Steven Pouillon said that his uncle was regularly threatened by residents for his anti-abortion protests, but that he never took them seriously.

“Everybody talked their smack, but my uncle was never afraid,” he said.

Mr. Pouillon frequently had visitors, Mr. Herald said, adding that he never saw any anti-abortion activity in the complex. “He was always at softball games watching his granddaughter play from his old Dodge van. He’d be there encouraging her.”

    Slain Abortion Opponent ‘Loved the Controversy’ His Protests Generated, NYT, 14.9.2009, http://www.nytimes.com/2009/09/14/us/14abortion.html

Letters

Putting America on a Healthier Diet

September 12, 2009
The New York Times

To the Editor:

Re “Big Food vs. Big Insurance,” by Michael Pollan (Op-Ed, Sept. 10):

Mr. Pollan rightly contends that health care reform will be ineffective unless the country’s increasing obesity problem is addressed. But because the food industry is only part of the problem, reforming it is only part of the solution.

The other part of the problem is the American consumer. While food producers provide an array of unhealthy fare, how, what and when we eat are personal choices.

Mr. Pollan praises attempts to tax sugary sodas because these products add empty calories to our diets, particularly for our youth. Yet sugar-free sodas have been available and widely consumed for 40 years. The choice is the consumer’s.

If we are to make headway on this issue, we must have comprehensive physical education and health education in our schools and incentives supporting healthy, active lifestyles and nutritional food choices for all citizens.

Like all industries, the food producers are driven by their bottom line. Only when consumers begin to demand healthier food will the industry change.

Anne-Marie Hislop
Davenport, Iowa, Sept. 10, 2009

•

To the Editor:

I applaud Michael Pollan’s recognition that obesity is the “elephant in the room” in the health care debate, but dissent on his solutions.

Taxing specific products such as soft drinks or creating yet another educational program will not get the job done. Multiple studies have demonstrated that “fat” taxes will not appreciably lower obesity rates, while attempts to change consumer eating behavior have historically come up short.

The real enemy is the number of excess calories available for consumption, regardless of the source. The only way to slim down this beast is to engage the food industry.

Rather than alienate or overregulate the industry, my recommendation is to put into effect tax incentives that would entice food companies to sell fewer calories. If they cut their calories, they would be rewarded. If they continued to spew excess calories on the public, they would risk losing favorable tax treatments.

This approach is well worth discussing. Our nation’s health depends on it.

Henry J. Cardello
Chapel Hill, N.C., Sept. 10, 2009

The writer is a former food industry executive and author of “Stuffed: An Insider’s Look at Who’s (Really) Making America Fat.”

•

To the Editor:

Eating well and exercising are important, but not necessarily a panacea against disease.

I am a 55-year-old woman who is slim, eats a healthy organic diet, takes ballet classes and practices yoga on a weekly basis.

I had breast cancer in 2003 and learned I had Stage 4 tonsil cancer in 2008. My out-of-the-pocket costs for my recent treatment for tonsil cancer totaled $15,000.

As part of my follow-up care, I need thousands of dollars of dental work, plus expensive magnetic resonance imaging every six months for the next three years. My monthly health insurance premium, for me alone, has gone up to $662.

Michael Pollan is correct in targeting agribusiness for contributing to obesity, but he does a grave disservice to me, and Americans in general, when he links the dire consequences of not having strong and meaningful health care reform with the honorable, but separate, issue of food industry reform.

Francesca Pastine
San Francisco, Sept. 10, 2009

•

To the Editor:

As a big fan of Michael Pollan, I was delighted to read “Big Food vs. Big Insurance.”

I am 65, look 50, and weigh 10 pounds more than when I graduated from high school, where I lettered in two sports. I work out three or four times a week, recently added two weekly yoga classes, take stairs whenever possible and have no major health issues.

My “diet” is to eat as much as I need, and no more. If my weight is up a little any morning, I just eat less that day.

My wife and I usually split the massive entrees at restaurants, we eat very little meat, and our snacks are fruits and nuts. And yes, I indulge — with a little delicious dark chocolate and low-fat ice cream every day.

I don’t eat junk food or buy the soft drinks and other reconstituted muck that American agribusiness currently substitutes for real food.

When Americans demand that restaurants and agribusiness put our health first, I will no longer be unusual.

James G. Goodale
Houston, Sept. 10, 2009

•

To the Editor:

Michael Pollan’s essay on the role of the food industry in contributing to obesity and associated chronic diseases may have some merit, but only because too many consumers make poor dietary choices, meal after meal, day after day.

Are we really going to blame the food industry for providing foods we enjoy but overindulge in? When did personal responsibility go out the window?

Most of us like a good hamburger with all the “fixings,” maybe even fries and a shake with it. But is the provider to blame when we consume them day after day, and couple this with other food choices that are high in calories and fat, with little or no exercise to offset these poor dietary choices?

The old saying that there are no good foods or bad foods, only good or bad diets, is still relevant.

Rather than play the blame game, we should direct our efforts at better educating consumers on the importance of balancing caloric intake with energy output.

Taxing or blaming the food industry may add more money to the government coffers, and make some feel better, but it has no public benefit.

James Stanley
Jasper, Ga., Sept. 10, 2009

    Putting America on a Healthier Diet, NYT, 12.9.2009, http://www.nytimes.com/2009/09/12/opinion/l12pollan.html

Op-Ed Contributor

Big Food vs. Big Insurance

September 10, 2009
The New York Times
By MICHAEL POLLAN

Berkeley, Calif.

TO listen to President Obama’s speech on Wednesday night, or to just about anyone else in the health care debate, you would think that the biggest problem with health care in America is the system itself — perverse incentives, inefficiencies, unnecessary tests and procedures, lack of competition, and greed.

No one disputes that the $2.3 trillion we devote to the health care industry is often spent unwisely, but the fact that the United States spends twice as much per person as most European countries on health care can be substantially explained, as a study released last month says, by our being fatter. Even the most efficient health care system that the administration could hope to devise would still confront a rising tide of chronic disease linked to diet.

That’s why our success in bringing health care costs under control ultimately depends on whether Washington can summon the political will to take on and reform a second, even more powerful industry: the food industry.

According to the Centers for Disease Control and Prevention, three-quarters of health care spending now goes to treat “preventable chronic diseases.” Not all of these diseases are linked to diet — there’s smoking, for instance — but many, if not most, of them are.

We’re spending $147 billion to treat obesity, $116 billion to treat diabetes, and hundreds of billions more to treat cardiovascular disease and the many types of cancer that have been linked to the so-called Western diet. One recent study estimated that 30 percent of the increase in health care spending over the past 20 years could be attributed to the soaring rate of obesity, a condition that now accounts for nearly a tenth of all spending on health care.

The American way of eating has become the elephant in the room in the debate over health care. The president has made a few notable allusions to it, and, by planting her vegetable garden on the South Lawn, Michelle Obama has tried to focus our attention on it. Just last month, Mr. Obama talked about putting a farmers’ market in front of the White House, and building new distribution networks to connect local farmers to public schools so that student lunches might offer more fresh produce and fewer Tater Tots. He’s even floated the idea of taxing soda.

But so far, food system reform has not figured in the national conversation about health care reform. And so the government is poised to go on encouraging America’s fast-food diet with its farm policies even as it takes on added responsibilities for covering the medical costs of that diet. To put it more bluntly, the government is putting itself in the uncomfortable position of subsidizing both the costs of treating Type 2 diabetes and the consumption of high-fructose corn syrup.

Why the disconnect? Probably because reforming the food system is politically even more difficult than reforming the health care system. At least in the health care battle, the administration can count some powerful corporate interests on its side — like the large segment of the Fortune 500 that has concluded the current system is unsustainable.

That is hardly the case when it comes to challenging agribusiness. Cheap food is going to be popular as long as the social and environmental costs of that food are charged to the future. There’s lots of money to be made selling fast food and then treating the diseases that fast food causes. One of the leading products of the American food industry has become patients for the American health care industry.

The market for prescription drugs and medical devices to manage Type 2 diabetes, which the Centers for Disease Control estimates will afflict one in three Americans born after 2000, is one of the brighter spots in the American economy. As things stand, the health care industry finds it more profitable to treat chronic diseases than to prevent them. There’s more money in amputating the limbs of diabetics than in counseling them on diet and exercise.

As for the insurers, you would think preventing chronic diseases would be good business, but, at least under the current rules, it’s much better business simply to keep patients at risk for chronic disease out of your pool of customers, whether through lifetime caps on coverage or rules against pre-existing conditions or by figuring out ways to toss patients overboard when they become ill.

But these rules may well be about to change — and, when it comes to reforming the American diet and food system, that step alone could be a game changer. Even under the weaker versions of health care reform now on offer, health insurers would be required to take everyone at the same rates, provide a standard level of coverage and keep people on their rolls regardless of their health. Terms like “pre-existing conditions” and “underwriting” would vanish from the health insurance rulebook — and, when they do, the relationship between the health insurance industry and the food industry will undergo a sea change.

The moment these new rules take effect, health insurance companies will promptly discover they have a powerful interest in reducing rates of obesity and chronic diseases linked to diet. A patient with Type 2 diabetes incurs additional health care costs of more than $6,600 a year; over a lifetime, that can come to more than $400,000. Insurers will quickly figure out that every case of Type 2 diabetes they can prevent adds $400,000 to their bottom line. Suddenly, every can of soda or Happy Meal or chicken nugget on a school lunch menu will look like a threat to future profits.

When health insurers can no longer evade much of the cost of treating the collateral damage of the American diet, the movement to reform the food system — everything from farm policy to food marketing and school lunches — will acquire a powerful and wealthy ally, something it hasn’t really ever had before.

AGRIBUSINESS dominates the agriculture committees of Congress, and has swatted away most efforts at reform. But what happens when the health insurance industry realizes that our system of farm subsidies makes junk food cheap, and fresh produce dear, and thus contributes to obesity and Type 2 diabetes? It will promptly get involved in the fight over the farm bill — which is to say, the industry will begin buying seats on those agriculture committees and demanding that the next bill be written with the interests of the public health more firmly in mind.

In the same way much of the health insurance industry threw its weight behind the campaign against smoking, we can expect it to support, and perhaps even help pay for, public education efforts like New York City’s bold new ad campaign against drinking soda. At the moment, a federal campaign to discourage the consumption of sweetened soft drinks is a political nonstarter, but few things could do more to slow the rise of Type 2 diabetes among adolescents than to reduce their soda consumption, which represents 15 percent of their caloric intake.

That’s why it’s easy to imagine the industry throwing its weight behind a soda tax. School lunch reform would become its cause, too, and in time the industry would come to see that the development of regional food systems, which make fresh produce more available and reduce dependence on heavily processed food from far away, could help prevent chronic disease and reduce their costs.

Recently a team of designers from M.I.T. and Columbia was asked by the foundation of the insurer UnitedHealthcare to develop an innovative systems approach to tackling childhood obesity in America. Their conclusion surprised the designers as much as their sponsor: they determined that promoting the concept of a “foodshed” — a diversified, regional food economy — could be the key to improving the American diet.

All of which suggests that passing a health care reform bill, no matter how ambitious, is only the first step in solving our health care crisis. To keep from bankrupting ourselves, we will then have to get to work on improving our health — which means going to work on the American way of eating.

But even if we get a health care bill that does little more than require insurers to cover everyone on the same basis, it could put us on that course.

For it will force the industry, and the government, to take a good hard look at the elephant in the room and galvanize a movement to slim it down.

 

Michael Pollan, a contributing writer for The Times Magazine and a professor of journalism at the University of California, Berkeley, is the author of “In Defense of Food: An Eater’s Manifesto.”

    Big Food vs. Big Insurance, NYT, 10.9.2009, http://www.nytimes.com/2009/09/10/opinion/10pollan.html

Abortion Protester

Is Killed in Michigan

September 12, 2009
The New York Times
By EMMA GRAVES FITZSIMMONS

A man who had long opposed abortion and was known nationally among anti-abortion protesters was shot to death Friday morning while staging a protest outside a Michigan high school, the authorities said.

Leaders of anti-abortion groups said they knew of no other instance in which a person protesting against abortion had been killed. In May, Dr. George R. Tiller, an abortion provider in Kansas, was shot to death in a crime that renewed debate over the use of violence in the abortion battle.

The protester, identified as James Pouillon, 63, was one of two people, the authorities said, who were shot dead Friday by the same man in Owosso, a city of fewer than 15,000 people about 10 miles west of Flint, Mich. The other victim, a local businessman, was not connected to the anti-abortion movement, the authorities said.

A suspect was arrested and charged in both killings.

Troy Newman, the president of the national anti-abortion group Operation Rescue, which had condemned Dr. Tiller’s death, said he was saddened by the death Mr. Pouillon, whom he had known for more than 15 years.

“There is very little, if any, common ground between pro-abortion and pro-life people,” Mr. Newman said. “One thing we had in common after Dr. Tiller’s death, there was a unilateral cry against violence.

A spokeswoman for the Center for Reproductive Rights, Laura MacCleery, said her group, which supports a woman’s right to abortion, was stunned by the “senseless killings.” But Ms. MacCleery said Friday’s shooting did not seem to her to be tied to the abortion debate since the suspect was also charged in the killing of the second man, Mike Fuoss, 61, the owner of a local gravel company, who did not appear to be involved in the abortion issue.

“This is not something any group on either side of this debate would ever contemplate condoning,” Ms. MacCleery said.

Prosecutors said that the suspect had singled out Mr. Pouillon because of the visible style of his regular protests at the school, but that they were uncertain whether the broader political message of the protests was at issue.

“There was some displeasure with how open he was,” said Sara Edwards, the chief assistant prosecutor for Shiawassee County. “He tended to carry big signs with very graphic pictures of fetuses.”

According to the police, Mr. Pouillon was protesting just outside the high school at 7 a.m. as students gathered for the day, when several shots were fired at him from a passing car. A witness provided the car’s license plate number, and the police arrested the suspect, Harlan James Drake, 33, at his home in Owosso a short time later.

The police said Mr. Drake told them that he had also been involved in another shooting, at Fuoss Gravel in nearby Owosso Township. Mr. Fuoss was found dead in his office about 8 a.m.

Prosecutors said Mr. Fuoss was not involved in abortion protests and had no link to Mr. Pouillon. Mr. Drake, they said, was angry at him for another reason. They did not elaborate.

Mr. Drake was charged with two counts of first-degree murder and with weapons charges and held without bond.

Prosecutors said he had also planned to shoot a third person, whom he apparently failed to find before he was arrested.

Monica Migliorino Miller, a Michigan anti-abortion leader who knew Mr. Pouillon, said he wore leg braces and used an oxygen tank and had protested for years outside of various Planned Parenthood offices and abortion clinics in Flint.

“He was just a quiet, unassuming, very committed pro-life activist,” Ms. Miller said.

Mr. Pouillon had planned to attend a national protest against abortion at the United States Capitol this weekend, Mr. Newman said. Now organizers are planning a vigil in his memory.

    Abortion Protester Is Killed in Michigan, NYT, 12.9.2009, http://www.nytimes.com/2009/09/12/us/12slay.html

Obama Cites Rising Uninsured

in Follow-Up to Speech

September 11, 2009
The New York Times
By SHERYL GAY STOLBERG
and JEFF ZELENY

WASHINGTON — President Obama, seeking to buttress his case for the kind of comprehensive health care overhaul that has eluded Washington for decades, told an audience of nurses on Thursday that the number of uninsured Americans rose by nearly 6 million as the recession intensified during the last 12 months.

“Now is the time to act,” Mr. Obama said, “and I will not permit reform to be postponed or imperiled by the usual ideological diversions.”

On the morning after Mr. Obama’s blunt address on health care to a joint session of Congress, he addressed the nurses on the White House campus — and received the endorsement of their professional association, administration officials said. He used his brief appearance to reinforce Wednesday night’s message that his plan will bring “security and stability” to those who have insurance, and coverage to those who do not.

The event marked the beginning of what the White House regards as the final, crucial phase of the health care debate, in which Mr. Obama will move aggressively to try to close the deal with lawmakers and the American public. The president intends to meet later Thursday at the White House with centrist Democrats, whose support is essential to passing legislation in the Senate. On Saturday, he will return to his bully pulpit, with a campaign-style rally in Minneapolis.

“Most Americans do have insurance and have never had less security and stability than they do right now,” Mr. Obama told the nurses, “because they’re subject to the whims of health insurance companies.”

The White House said the assertion that there are 6 million more unemployed Americans came from a new Gallup Survey that tracked changes in the number of uninsured between September 2008 and today.

Mr. Obama vowed on Wednesday night that he would “not waste time” with those who have made a political calculation to oppose him. But he left the door open to working with Republicans to cut health costs and expand coverage to millions of Americans.

The White House offensive comes after a rocky August, in which many lawmakers held public meetings that deteriorated into shouting matches over health care.

The president placed a price tag on the plan of about $900 billion over 10 years, which he said was “less than we have spent on the Iraq and Afghanistan wars.” And he sought to reassure the elderly and the Americans who already have insurance that they would not be worse off.

As expected, Mr. Obama repeated his support for a government insurance plan to compete with the private sector, though he said he would consider alternatives to the “public option.”

He sketched out a vision for a plan in which it would be illegal for insurers to drop sick people or deny them coverage for pre-existing conditions, and in which every American would be required to carry health coverage, just as drivers must carry auto insurance.

Mr. Obama did embrace some fresh proposals. He announced a new initiative to create pilot projects intended to curb medical malpractice lawsuits, a cause important to physicians and Republicans.

He endorsed a plan, included in a proposal by Senator Max Baucus, the Montana Democrat who is chairman of the Senate Finance Committee, to help pay for expanding coverage by taxing insurance companies that offer expensive, so-called gold-plated insurance plans. And the president promised to include a provision that “requires us to come forward with more spending cuts” if the savings he envisions do not materialize.

Republicans seemed primed for a fight; many, like Senator Charles E. Grassley, the Iowa Republican who has been deeply involved in health negotiations, released statements about the speech even before it began. Mr. Grassley called on Mr. Obama to “start building the kind of legislation that could win the support of 70 to 80 senators,” a goal Mr. Grassley said could not be achieved if the bill contained a new government plan.

 

David Stout contributed reporting.

    Obama Cites Rising Uninsured in Follow-Up to Speech, NYT, 11.9.2009, http://www.nytimes.com/2009/09/11/us/politics/11obama.html

Editorial

President Obama Steps Forward

September 10, 2009
The New York Times

For a man who made health care reform his top domestic priority, President Obama stood on the sidelines throughout a long difficult spring and politically overheated summer. He left it primarily to Congress to flesh out the details of reform and waited in vain for a bipartisan compromise to emerge — a virtual impossibility from the start given the determination of top Republicans to kill his effort and cripple his administration.

On Wednesday night, reeling from the angry if ill-informed outbursts at town hall meetings and concerned about his slipping poll numbers, the president finally found his voice. His speech to a joint session of Congress was rhetorically powerful in its insistence that reform must finally happen — for the sake of Americans’ health and the economic health of the country. We hope it was only the start of a sustained campaign to get this essential legislation passed.

Mr. Obama did well to reveal his requirements for meaningful reform. He stood by the importance of requiring everyone to carry insurance and requiring businesses to provide it or pay to help cover their workers’ costs. That is critical to ensuring a big enough pool of healthy and unhealthy people to spread risks fairly.

Mr. Obama said the plan he is proposing would cost about $900 billion over 10 years, mostly to expand Medicaid coverage of the poor and provide subsidies for low- and middle-income Americans to buy policies on new health insurance exchanges.

Mr. Obama fell short when he failed to say how generous the subsidies should be and who should be eligible to receive them. His $900 billion may not be enough to cover nearly all of the uninsured. Congress should increase it.

Equally important, Mr. Obama pledged that his plan would not add to the nation’s enormous deficit now or in the future. He said any legislation must include a provision that requires additional spending cuts if reforms don’t provide the expected savings.

Mr. Obama was absolutely right when he said that the relentless rise in the cost of Medicare and Medicaid will cripple the nation’s economy. But Americans need to hear a lot more from him and from Congress about how they will address that problem. Anyone opposed to reform has to answer that same question.

Mr. Obama made a strong case for creating a new public plan to compete with private plans on the exchanges.

He is right that all Americans will benefit if the insurance companies have more competition, but he stopped short of declaring a public plan a necessity. It may not be, but it is too soon to abandon the idea. He should trade it away only in return for significant political support — and should demand a trigger to resurrect it should private plans fail to provide affordable policies.

The president was right to stress that reform is essential not just for the uninsured but for all Americans — far too many of us are just a layoff or a job switch or a divorce or an illness away from losing coverage. He said his plan would make it unlawful for insurance companies to deny coverage or refuse to renew it based on health status, and would limit how much people can be charged for out-of-pocket expenses such as co-payments.

We believe that Mr. Obama has been far too passive — for the sake of an unrequited bipartisanship — as his opponents have twisted and distorted the health care debate. It was encouraging to hear him reject those distortions — specifically the absurd charge that he was opening the door to “death panels” — as lies.

And he finally laid down a warning: “I will not waste time with those who have made the calculation that it’s better politics to kill this plan than improve it.” He should stick to that commitment.

Having let his opponents frame the debate for far too long, Mr. Obama will need to do more than orate. He needs to twist arms among timid Democrats in Congress to get a strong bill passed, most likely with little support from Republicans.

    President Obama Steps Forward, NYT, 10.9.2009, http://www.nytimes.com/2009/09/10/opinion/10thu1.html

Obama Vows

to ‘Deliver on Health Care’

September 10, 2009
The New York Times
By SHERYL GAY STOLBERG
and JEFF ZELENY

WASHINGTON — President Obama confronted a critical Congress and a skeptical nation on Wednesday, decrying the “scare tactics” of his opponents and presenting his most forceful case yet for a sweeping health care overhaul that has eluded Washington for generations.

In blunt language before a rare joint session of Congress, Mr. Obama vowed that he would “not waste time” with those who have made a political calculation to oppose him, but left the door open to working with Republicans to cut health costs and expand coverage to millions of Americans.

“The time for bickering is over,” the president declared. “The time for games has passed. Now is the season for action.”

The president was greeted by booming applause from Democrats and polite handshakes from Republicans. But the political challenge at hand soon became clear as several Republican lawmakers heckled Mr. Obama when he dismissed the notion that so-called death panels would deny care to the elderly.

“It is a lie, plain and simple,” Mr. Obama declared.

“You lie!” Representative Joe Wilson of South Carolina yelled back after Mr. Obama said it was not true that the Democrats were proposing to provide health coverage to illegal immigrants.

The 47-minute speech was an effort by Mr. Obama to regain his political footing on health care, his highest legislative priority. He insisted throughout that he had not closed the door on reaching a bipartisan compromise. He gave a nod to Senator John McCain, Republican of Arizona, and embraced his proposal to create a high-risk pool to help cover people with pre-existing conditions against catastrophic expenses.

And, with the widow of Senator Edward M. Kennedy sitting in the House gallery, the president appealed to the nation’s conscience, reading a letter Mr. Kennedy had written in May with instructions that it be delivered to the president upon his death. In it, Mr. Kennedy wrote that health care was “above all a moral issue; at stake are not just the details of policy, but fundamental principles of social justice and the character of our country.”

Presidents since Theodore Roosevelt have been advocating universal health care without success, and Mr. Obama vowed to fare better. “I am not the first president to take up this cause,” he said, “but I am determined to be the last.”

The speech came after a rocky August for the White House, in which many lawmakers held public meetings that deteriorated into shouting matches over health care.

After months of insisting he would leave the specifics to lawmakers, Mr. Obama used the speech to present his most detailed outline yet of a plan he said would provide “security and stability” to those who have insurance and cover those who do not, all without adding to the federal deficit.

The president placed a price tag on the plan of about $900 billion over 10 years, which he said was “less than we have spent on the Iraq and Afghanistan wars.” But he devoted much of his address to making the case for why such a plan is necessary, and sought to reassure the elderly and the Americans who already have insurance that they would not be worse off.

As expected, Mr. Obama repeated his support for a government insurance plan to compete with the private sector, though he said he would consider alternatives to the “public option.”

He sketched out a vision for a plan in which it would be illegal for insurers to drop sick people or deny them coverage for pre-existing conditions, and in which every American would be required to carry health coverage, just as drivers must carry auto insurance.

Mr. Obama did embrace some fresh proposals. He announced a new initiative to create pilot projects intended to curb medical malpractice lawsuits, a cause important to physicians and Republicans.

He endorsed a plan, contained in a draft proposal being circulated by Senator Max Baucus, the Montana Democrat who is chairman of the Senate Finance Committee, to help pay for expanding coverage by taxing insurance companies that offer expensive, so-called gold-plated insurance plans.

And, seeking to reassure those who worry he will run up the federal deficit, Mr. Obama promised to include a provision that “requires us to come forward with more spending cuts” if the savings he envisions do not materialize.

In embracing Mr. McCain and the malpractice projects, the White House appeared to be seeking to lay the groundwork for an argument that the final bill would be bipartisan not because it garners Republican votes but because it contains Republican ideas. That is the same argument Mr. Obama used when the economic recovery package passed with just three Republican votes.

Republicans seemed primed for a fight; many, like Senator Charles E. Grassley, the Iowa Republican who has been deeply involved in health negotiations, released statements about the speech even before it began. Mr. Grassley called on Mr. Obama to “start building the kind of legislation that could win the support of 70 to 80 senators,” a goal Mr. Grassley said could not be achieved if the bill contained a new government plan.

In the Republican response, Representative Charles Boustany Jr. of Louisiana, a heart surgeon, agreed that the health care system needed an overhaul. But he urged the president to start anew, focusing on a “common-sense, bipartisan plan.”

An hour after the speech, Mr. Wilson, the heckler, issued an apology for his outburst.

The speech was the president’s second address before a joint session of Congress. But the political backdrop on Wednesday was far different from his appearance in the House chamber on the 36th day of his term, when an optimistic wave of momentum was at his back and his Republican rivals were dispirited and in disarray.

“What we have also seen in these last months is the same partisan spectacle that only hardens the disdain many Americans have toward their own government. Instead of honest debate, we have seen scare tactics,” Mr. Obama said. “Some have dug into unyielding ideological camps that offer no hope of compromise. Too many have used this as an opportunity to score short-term political points, even if it robs the country of our opportunity to solve a long-term challenge.”

He added, “And out of this blizzard of charges and countercharges, confusion has reigned.”

While Mr. Obama was addressing lawmakers inside the ornate House chamber, the much more important audience was outside Washington: the 180 million Americans who already have health insurance and who remain skeptical that Mr. Obama’s plan will change things for the better. Inside the chamber, the president drew laughter when he said, “there remain some significant details to be ironed out.”

For Mr. Obama, the speech was a go-for-broke moment; there is no more dramatic venue for a president than an address to a joint session to Congress. For many Democrats, the speech evoked memories of a similar health care address by President Bill Clinton, 16 years ago this month. Mr. Clinton called for “security, simplicity, savings, choice, quality and responsibility” — the same broad themes Mr. Obama evoked Wednesday night.

The architect of the Clinton plan, of course, was Mr. Clinton’s wife, Hillary Rodham Clinton.

On Wednesday night, Mr. Obama’s wife, Michelle, sat quietly in the House gallery, holding the hand of Victoria Reggie Kennedy, Mr. Kennedy’s widow. Mrs. Clinton, now Mr. Obama’s secretary of state, sat in the front row, smiling and shaking hands.

    Obama Vows to ‘Deliver on Health Care’, NYT, 10.09.2009, http://www.nytimes.com/2009/09/10/us/politics/10obama.html

Text

Obama’s

Health Care Speech to Congress

September 10, 2009
The New York Times

Following is the prepared text of President Obama’s speech to Congress on the need to overhaul health care in the United States, as released by the White House.

Madame Speaker, Vice President Biden, Members of Congress, and the American people:

When I spoke here last winter, this nation was facing the worst economic crisis since the Great Depression. We were losing an average of 700,000 jobs per month. Credit was frozen. And our financial system was on the verge of collapse.

As any American who is still looking for work or a way to pay their bills will tell you, we are by no means out of the woods. A full and vibrant recovery is many months away. And I will not let up until those Americans who seek jobs can find them; until those businesses that seek capital and credit can thrive; until all responsible homeowners can stay in their homes. That is our ultimate goal. But thanks to the bold and decisive action we have taken since January, I can stand here with confidence and say that we have pulled this economy back from the brink.

I want to thank the members of this body for your efforts and your support in these last several months, and especially those who have taken the difficult votes that have put us on a path to recovery. I also want to thank the American people for their patience and resolve during this trying time for our nation.

But we did not come here just to clean up crises. We came to build a future. So tonight, I return to speak to all of you about an issue that is central to that future – and that is the issue of health care.

I am not the first President to take up this cause, but I am determined to be the last. It has now been nearly a century since Theodore Roosevelt first called for health care reform. And ever since, nearly every President and Congress, whether Democrat or Republican, has attempted to meet this challenge in some way. A bill for comprehensive health reform was first introduced by John Dingell Sr. in 1943. Sixty-five years later, his son continues to introduce that same bill at the beginning of each session.

Our collective failure to meet this challenge – year after year, decade after decade – has led us to a breaking point. Everyone understands the extraordinary hardships that are placed on the uninsured, who live every day just one accident or illness away from bankruptcy. These are not primarily people on welfare. These are middle-class Americans. Some can't get insurance on the job. Others are self-employed, and can't afford it, since buying insurance on your own costs you three times as much as the coverage you get from your employer. Many other Americans who are willing and able to pay are still denied insurance due to previous illnesses or conditions that insurance companies decide are too risky or expensive to cover.

We are the only advanced democracy on Earth – the only wealthy nation – that allows such hardships for millions of its people. There are now more than thirty million American citizens who cannot get coverage. In just a two year period, one in every three Americans goes without health care coverage at some point. And every day, 14,000 Americans lose their coverage. In other words, it can happen to anyone.

But the problem that plagues the health care system is not just a problem of the uninsured. Those who do have insurance have never had less security and stability than they do today. More and more Americans worry that if you move, lose your job, or change your job, you'll lose your health insurance too. More and more Americans pay their premiums, only to discover that their insurance company has dropped their coverage when they get sick, or won't pay the full cost of care. It happens every day.

One man from Illinois lost his coverage in the middle of chemotherapy because his insurer found that he hadn't reported gallstones that he didn't even know about. They delayed his treatment, and he died because of it. Another woman from Texas was about to get a double mastectomy when her insurance company canceled her policy because she forgot to declare a case of acne. By the time she had her insurance reinstated, her breast cancer more than doubled in size. That is heart-breaking, it is wrong, and no one should be treated that way in the United States of America.

Then there's the problem of rising costs. We spend one-and-a-half times more per person on health care than any other country, but we aren't any healthier for it. This is one of the reasons that insurance premiums have gone up three times faster than wages. It's why so many employers – especially small businesses – are forcing their employees to pay more for insurance, or are dropping their coverage entirely. It's why so many aspiring entrepreneurs cannot afford to open a business in the first place, and why American businesses that compete internationally – like our automakers – are at a huge disadvantage. And it's why those of us with health insurance are also paying a hidden and growing tax for those without it – about $1000 per year that pays for somebody else's emergency room and charitable care.

Finally, our health care system is placing an unsustainable burden on taxpayers. When health care costs grow at the rate they have, it puts greater pressure on programs like Medicare and Medicaid. If we do nothing to slow these skyrocketing costs, we will eventually be spending more on Medicare and Medicaid than every other government program combined. Put simply, our health care problem is our deficit problem. Nothing else even comes close.

These are the facts. Nobody disputes them. We know we must reform this system. The question is how.

There are those on the left who believe that the only way to fix the system is through a single-payer system like Canada's, where we would severely restrict the private insurance market and have the government provide coverage for everyone. On the right, there are those who argue that we should end the employer-based system and leave individuals to buy health insurance on their own.

I have to say that there are arguments to be made for both approaches. But either one would represent a radical shift that would disrupt the health care most people currently have. Since health care represents one-sixth of our economy, I believe it makes more sense to build on what works and fix what doesn't, rather than try to build an entirely new system from scratch. And that is precisely what those of you in Congress have tried to do over the past several months.

During that time, we have seen Washington at its best and its worst.

We have seen many in this chamber work tirelessly for the better part of this year to offer thoughtful ideas about how to achieve reform. Of the five committees asked to develop bills, four have completed their work, and the Senate Finance Committee announced today that it will move forward next week. That has never happened before. Our overall efforts have been supported by an unprecedented coalition of doctors and nurses; hospitals, seniors' groups and even drug companies – many of whom opposed reform in the past. And there is agreement in this chamber on about eighty percent of what needs to be done, putting us closer to the goal of reform than we have ever been.

But what we have also seen in these last months is the same partisan spectacle that only hardens the disdain many Americans have toward their own government. Instead of honest debate, we have seen scare tactics. Some have dug into unyielding ideological camps that offer no hope of compromise. Too many have used this as an opportunity to score short-term political points, even if it robs the country of our opportunity to solve a long-term challenge. And out of this blizzard of charges and counter-charges, confusion has reigned.

Well the time for bickering is over. The time for games has passed. Now is the season for action. Now is when we must bring the best ideas of both parties together, and show the American people that we can still do what we were sent here to do. Now is the time to deliver on health care.

The plan I'm announcing tonight would meet three basic goals:

It will provide more security and stability to those who have health insurance. It will provide insurance to those who don't. And it will slow the growth of health care costs for our families, our businesses, and our government. It's a plan that asks everyone to take responsibility for meeting this challenge – not just government and insurance companies, but employers and individuals. And it's a plan that incorporates ideas from Senators and Congressmen; from Democrats and Republicans – and yes, from some of my opponents in both the primary and general election.

Here are the details that every American needs to know about this plan:

First, if you are among the hundreds of millions of Americans who already have health insurance through your job, Medicare, Medicaid, or the VA, nothing in this plan will require you or your employer to change the coverage or the doctor you have. Let me repeat this: nothing in our plan requires you to change what you have.

What this plan will do is to make the insurance you have work better for you. Under this plan, it will be against the law for insurance companies to deny you coverage because of a pre-existing condition. As soon as I sign this bill, it will be against the law for insurance companies to drop your coverage when you get sick or water it down when you need it most. They will no longer be able to place some arbitrary cap on the amount of coverage you can receive in a given year or a lifetime. We will place a limit on how much you can be charged for out-of-pocket expenses, because in the United States of America, no one should go broke because they get sick. And insurance companies will be required to cover, with no extra charge, routine checkups and preventive care, like mammograms and colonoscopies – because there's no reason we shouldn't be catching diseases like breast cancer and colon cancer before they get worse. That makes sense, it saves money, and it saves lives.

That's what Americans who have health insurance can expect from this plan – more security and stability.

Now, if you're one of the tens of millions of Americans who don't currently have health insurance, the second part of this plan will finally offer you quality, affordable choices. If you lose your job or change your job, you will be able to get coverage. If you strike out on your own and start a small business, you will be able to get coverage. We will do this by creating a new insurance exchange – a marketplace where individuals and small businesses will be able to shop for health insurance at competitive prices. Insurance companies will have an incentive to participate in this exchange because it lets them compete for millions of new customers. As one big group, these customers will have greater leverage to bargain with the insurance companies for better prices and quality coverage. This is how large companies and government employees get affordable insurance. It's how everyone in this Congress gets affordable insurance. And it's time to give every American the same opportunity that we've given ourselves.

For those individuals and small businesses who still cannot afford the lower-priced insurance available in the exchange, we will provide tax credits, the size of which will be based on your need. And all insurance companies that want access to this new marketplace will have to abide by the consumer protections I already mentioned. This exchange will take effect in four years, which will give us time to do it right. In the meantime, for those Americans who can't get insurance today because they have pre-existing medical conditions, we will immediately offer low-cost coverage that will protect you against financial ruin if you become seriously ill. This was a good idea when Senator John McCain proposed it in the campaign, it's a good idea now, and we should embrace it.

Now, even if we provide these affordable options, there may be those – particularly the young and healthy – who still want to take the risk and go without coverage. There may still be companies that refuse to do right by their workers. The problem is, such irresponsible behavior costs all the rest of us money. If there are affordable options and people still don't sign up for health insurance, it means we pay for those people's expensive emergency room visits. If some businesses don't provide workers health care, it forces the rest of us to pick up the tab when their workers get sick, and gives those businesses an unfair advantage over their competitors. And unless everybody does their part, many of the insurance reforms we seek – especially requiring insurance companies to cover pre-existing conditions – just can't be achieved.

That's why under my plan, individuals will be required to carry basic health insurance – just as most states require you to carry auto insurance. Likewise, businesses will be required to either offer their workers health care, or chip in to help cover the cost of their workers. There will be a hardship waiver for those individuals who still cannot afford coverage, and 95% of all small businesses, because of their size and narrow profit margin, would be exempt from these requirements. But we cannot have large businesses and individuals who can afford coverage game the system by avoiding responsibility to themselves or their employees. Improving our health care system only works if everybody does their part.

While there remain some significant details to be ironed out, I believe a broad consensus exists for the aspects of the plan I just outlined: consumer protections for those with insurance, an exchange that allows individuals and small businesses to purchase affordable coverage, and a requirement that people who can afford insurance get insurance.

And I have no doubt that these reforms would greatly benefit Americans from all walks of life, as well as the economy as a whole. Still, given all the misinformation that's been spread over the past few months, I realize that many Americans have grown nervous about reform. So tonight I'd like to address some of the key controversies that are still out there.

Some of people's concerns have grown out of bogus claims spread by those whose only agenda is to kill reform at any cost. The best example is the claim, made not just by radio and cable talk show hosts, but prominent politicians, that we plan to set up panels of bureaucrats with the power to kill off senior citizens. Such a charge would be laughable if it weren't so cynical and irresponsible. It is a lie, plain and simple.

There are also those who claim that our reform effort will insure illegal immigrants. This, too, is false – the reforms I'm proposing would not apply to those who are here illegally. And one more misunderstanding I want to clear up – under our plan, no federal dollars will be used to fund abortions, and federal conscience laws will remain in place.

My health care proposal has also been attacked by some who oppose reform as a "government takeover" of the entire health care system. As proof, critics point to a provision in our plan that allows the uninsured and small businesses to choose a publicly-sponsored insurance option, administered by the government just like Medicaid or Medicare.

So let me set the record straight. My guiding principle is, and always has been, that consumers do better when there is choice and competition. Unfortunately, in 34 states, 75% of the insurance market is controlled by five or fewer companies. In Alabama, almost 90% is controlled by just one company. Without competition, the price of insurance goes up and the quality goes down. And it makes it easier for insurance companies to treat their customers badly – by cherry-picking the healthiest individuals and trying to drop the sickest; by overcharging small businesses who have no leverage; and by jacking up rates.

Insurance executives don't do this because they are bad people. They do it because it's profitable. As one former insurance executive testified before Congress, insurance companies are not only encouraged to find reasons to drop the seriously ill; they are rewarded for it. All of this is in service of meeting what this former executive called "Wall Street's relentless profit expectations."

Now, I have no interest in putting insurance companies out of business. They provide a legitimate service, and employ a lot of our friends and neighbors. I just want to hold them accountable. The insurance reforms that I've already mentioned would do just that. But an additional step we can take to keep insurance companies honest is by making a not-for-profit public option available in the insurance exchange. Let me be clear – it would only be an option for those who don't have insurance. No one would be forced to choose it, and it would not impact those of you who already have insurance. In fact, based on Congressional Budget Office estimates, we believe that less than 5% of Americans would sign up.

Despite all this, the insurance companies and their allies don't like this idea. They argue that these private companies can't fairly compete with the government. And they'd be right if taxpayers were subsidizing this public insurance option. But they won't be. I have insisted that like any private insurance company, the public insurance option would have to be self-sufficient and rely on the premiums it collects. But by avoiding some of the overhead that gets eaten up at private companies by profits, excessive administrative costs and executive salaries, it could provide a good deal for consumers. It would also keep pressure on private insurers to keep their policies affordable and treat their customers better, the same way public colleges and universities provide additional choice and competition to students without in any way inhibiting a vibrant system of private colleges and universities.

It's worth noting that a strong majority of Americans still favor a public insurance option of the sort I've proposed tonight. But its impact shouldn't be exaggerated – by the left, the right, or the media. It is only one part of my plan, and should not be used as a handy excuse for the usual Washington ideological battles. To my progressive friends, I would remind you that for decades, the driving idea behind reform has been to end insurance company abuses and make coverage affordable for those without it. The public option is only a means to that end – and we should remain open to other ideas that accomplish our ultimate goal. And to my Republican friends, I say that rather than making wild claims about a government takeover of health care, we should work together to address any legitimate concerns you may have.

For example, some have suggested that that the public option go into effect only in those markets where insurance companies are not providing affordable policies. Others propose a co-op or another non-profit entity to administer the plan. These are all constructive ideas worth exploring. But I will not back down on the basic principle that if Americans can't find affordable coverage, we will provide you with a choice. And I will make sure that no government bureaucrat or insurance company bureaucrat gets between you and the care that you need.

Finally, let me discuss an issue that is a great concern to me, to members of this chamber, and to the public – and that is how we pay for this plan.

Here's what you need to know. First, I will not sign a plan that adds one dime to our deficits – either now or in the future. Period. And to prove that I'm serious, there will be a provision in this plan that requires us to come forward with more spending cuts if the savings we promised don't materialize. Part of the reason I faced a trillion dollar deficit when I walked in the door of the White House is because too many initiatives over the last decade were not paid for – from the Iraq War to tax breaks for the wealthy. I will not make that same mistake with health care.

Second, we've estimated that most of this plan can be paid for by finding savings within the existing health care system – a system that is currently full of waste and abuse. Right now, too much of the hard-earned savings and tax dollars we spend on health care doesn't make us healthier. That's not my judgment – it's the judgment of medical professionals across this country. And this is also true when it comes to Medicare and Medicaid.

In fact, I want to speak directly to America's seniors for a moment, because Medicare is another issue that's been subjected to demagoguery and distortion during the course of this debate.

More than four decades ago, this nation stood up for the principle that after a lifetime of hard work, our seniors should not be left to struggle with a pile of medical bills in their later years. That is how Medicare was born. And it remains a sacred trust that must be passed down from one generation to the next. That is why not a dollar of the Medicare trust fund will be used to pay for this plan.

The only thing this plan would eliminate is the hundreds of billions of dollars in waste and fraud, as well as unwarranted subsidies in Medicare that go to insurance companies – subsidies that do everything to pad their profits and nothing to improve your care. And we will also create an independent commission of doctors and medical experts charged with identifying more waste in the years ahead.

These steps will ensure that you – America's seniors – get the benefits you've been promised. They will ensure that Medicare is there for future generations. And we can use some of the savings to fill the gap in coverage that forces too many seniors to pay thousands of dollars a year out of their own pocket for prescription drugs. That's what this plan will do for you. So don't pay attention to those scary stories about how your benefits will be cut – especially since some of the same folks who are spreading these tall tales have fought against Medicare in the past, and just this year supported a budget that would have essentially turned Medicare into a privatized voucher program. That will never happen on my watch. I will protect Medicare.

Now, because Medicare is such a big part of the health care system, making the program more efficient can help usher in changes in the way we deliver health care that can reduce costs for everybody. We have long known that some places, like the Intermountain Healthcare in Utah or the Geisinger Health System in rural Pennsylvania, offer high-quality care at costs below average. The commission can help encourage the adoption of these common-sense best practices by doctors and medical professionals throughout the system – everything from reducing hospital infection rates to encouraging better coordination between teams of doctors.

Reducing the waste and inefficiency in Medicare and Medicaid will pay for most of this plan. Much of the rest would be paid for with revenues from the very same drug and insurance companies that stand to benefit from tens of millions of new customers. This reform will charge insurance companies a fee for their most expensive policies, which will encourage them to provide greater value for the money – an idea which has the support of Democratic and Republican experts. And according to these same experts, this modest change could help hold down the cost of health care for all of us in the long-run.

Finally, many in this chamber – particularly on the Republican side of the aisle – have long insisted that reforming our medical malpractice laws can help bring down the cost of health care. I don't believe malpractice reform is a silver bullet, but I have talked to enough doctors to know that defensive medicine may be contributing to unnecessary costs. So I am proposing that we move forward on a range of ideas about how to put patient safety first and let doctors focus on practicing medicine. I know that the Bush Administration considered authorizing demonstration projects in individual states to test these issues. It's a good idea, and I am directing my Secretary of Health and Human Services to move forward on this initiative today.

Add it all up, and the plan I'm proposing will cost around $900 billion over ten years – less than we have spent on the Iraq and Afghanistan wars, and less than the tax cuts for the wealthiest few Americans that Congress passed at the beginning of the previous administration. Most of these costs will be paid for with money already being spent – but spent badly – in the existing health care system. The plan will not add to our deficit. The middle-class will realize greater security, not higher taxes. And if we are able to slow the growth of health care costs by just one-tenth of one percent each year, it will actually reduce the deficit by $4 trillion over the long term.

This is the plan I'm proposing. It's a plan that incorporates ideas from many of the people in this room tonight – Democrats and Republicans. And I will continue to seek common ground in the weeks ahead. If you come to me with a serious set of proposals, I will be there to listen. My door is always open.

But know this: I will not waste time with those who have made the calculation that it's better politics to kill this plan than improve it. I will not stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what's in the plan, we will call you out. And I will not accept the status quo as a solution. Not this time. Not now.

Everyone in this room knows what will happen if we do nothing. Our deficit will grow. More families will go bankrupt. More businesses will close. More Americans will lose their coverage when they are sick and need it most. And more will die as a result. We know these things to be true.

That is why we cannot fail. Because there are too many Americans counting on us to succeed – the ones who suffer silently, and the ones who shared their stories with us at town hall meetings, in emails, and in letters.

I received one of those letters a few days ago. It was from our beloved friend and colleague, Ted Kennedy. He had written it back in May, shortly after he was told that his illness was terminal. He asked that it be delivered upon his death.

In it, he spoke about what a happy time his last months were, thanks to the love and support of family and friends, his wife, Vicki, and his children, who are here tonight . And he expressed confidence that this would be the year that health care reform – "that great unfinished business of our society," he called it – would finally pass. He repeated the truth that health care is decisive for our future prosperity, but he also reminded me that "it concerns more than material things." "What we face," he wrote, "is above all a moral issue; at stake are not just the details of policy, but fundamental principles of social justice and the character of our country."

I've thought about that phrase quite a bit in recent days – the character of our country. One of the unique and wonderful things about America has always been our self-reliance, our rugged individualism, our fierce defense of freedom and our healthy skepticism of government. And figuring out the appropriate size and role of government has always been a source of rigorous and sometimes angry debate.

For some of Ted Kennedy's critics, his brand of liberalism represented an affront to American liberty. In their mind, his passion for universal health care was nothing more than a passion for big government.

But those of us who knew Teddy and worked with him here – people of both parties – know that what drove him was something more. His friend, Orrin Hatch, knows that. They worked together to provide children with health insurance. His friend John McCain knows that. They worked together on a Patient's Bill of Rights. His friend Chuck Grassley knows that. They worked together to provide health care to children with disabilities.

On issues like these, Ted Kennedy's passion was born not of some rigid ideology, but of his own experience. It was the experience of having two children stricken with cancer. He never forgot the sheer terror and helplessness that any parent feels when a child is badly sick; and he was able to imagine what it must be like for those without insurance; what it would be like to have to say to a wife or a child or an aging parent – there is something that could make you better, but I just can't afford it.

That large-heartedness – that concern and regard for the plight of others – is not a partisan feeling. It is not a Republican or a Democratic feeling. It, too, is part of the American character. Our ability to stand in other people's shoes. A recognition that we are all in this together; that when fortune turns against one of us, others are there to lend a helping hand. A belief that in this country, hard work and responsibility should be rewarded by some measure of security and fair play; and an acknowledgement that sometimes government has to step in to help deliver on that promise.

This has always been the history of our progress. In 1933, when over half of our seniors could not support themselves and millions had seen their savings wiped away, there were those who argued that Social Security would lead to socialism. But the men and women of Congress stood fast, and we are all the better for it. In 1965, when some argued that Medicare represented a government takeover of health care, members of Congress, Democrats and Republicans, did not back down. They joined together so that all of us could enter our golden years with some basic peace of mind.

You see, our predecessors understood that government could not, and should not, solve every problem. They understood that there are instances when the gains in security from government action are not worth the added constraints on our freedom. But they also understood that the danger of too much government is matched by the perils of too little; that without the leavening hand of wise policy, markets can crash, monopolies can stifle competition, and the vulnerable can be exploited. And they knew that when any government measure, no matter how carefully crafted or beneficial, is subject to scorn; when any efforts to help people in need are attacked as un-American; when facts and reason are thrown overboard and only timidity passes for wisdom, and we can no longer even engage in a civil conversation with each other over the things that truly matter – that at that point we don't merely lose our capacity to solve big challenges. We lose something essential about ourselves.

What was true then remains true today. I understand how difficult this health care debate has been. I know that many in this country are deeply skeptical that government is looking out for them. I understand that the politically safe move would be to kick the can further down the road – to defer reform one more year, or one more election, or one more term.

But that's not what the moment calls for. That's not what we came here to do. We did not come to fear the future. We came here to shape it. I still believe we can act even when it's hard. I still believe we can replace acrimony with civility, and gridlock with progress. I still believe we can do great things, and that here and now we will meet history's test.

Because that is who we are. That is our calling. That is our character. Thank you, God Bless You, and may God Bless the United States of America.

    Obama’s Health Care Speech to Congress, NYT, 10.9.2009, http://www.nytimes.com/2009/09/10/us/politics/10obama.text.html

Up to $3, 800 Fine

for Failure Get Health Insurance

September 8, 2009
Filed at 12:54 p.m. ET
The New York Times
By THE ASSOCIATED PRESS

WASHINGTON (AP) -- A top senator is calling for fines of up to $3,800 on families who fail to get medical insurance after a health care overhaul goes into effect.

The plan from Democratic Sen. Max Baucus of Montana would make health insurance mandatory, just like auto coverage. It would provide tax credits to help cover the cost for people making up to three times the federal poverty level. That's about $66,000 for a family of four, and $32,000 for an individual.

But those who still don't sign up would face hefty fines, starting at $750 a year for individuals and $1,500 for families. The maximum penalty on individuals would be $950.

Baucus is hoping his plan can win bipartisan support. A copy of his proposal was obtained by The Associated Press.

    Up to $3, 800 Fine for Failure Get Health Insurance, NYT, 8.9.2009, http://www.nytimes.com/aponline/2009/09/08/us/politics/AP-US-Health-Care-Baucus-Plan.html

Op-Ed Columnist

A More Perfect Death

September 7, 2009
The New York Times
By ROSS DOUTHAT

As if there weren’t enough end-of-life anxieties floating around the health care debate, the Montana Supreme Court has chosen this month to weigh whether their state should join nearby Oregon and Washington in endorsing physician-assisted suicide.

What’s at stake is the right to voluntary euthanasia, not the sort of involuntary plug-pulling that some Republicans have claimed is concealed in the finer print of the current health care reform proposals. But you don’t have to share Sarah Palin’s death panel fears to see perils lurking at the intersection of physician-assisted suicide and health care reform.

Consider the words of a prominent oncologist, bioethicist and health care wonk, critiquing assisted suicide in 1997, just before a Supreme Court ruling on the issue. “Once legalized,” this writer warned in the pages of The Atlantic, “euthanasia would become routine. Over time doctors would become comfortable giving injections to end life and Americans would become comfortable having euthanasia as an option.” From there, it would be an easy slide to euthanizing the incompetent: “Comfort would make us want to extend the option to others who, in society’s view, are suffering and leading purposeless lives.”

Comfort — and budgetary constraints. Euthanasia would be much more likely to pass from an exception to a rule, the bioethicist argued, “in the context of demographic and budgetary pressures on Social Security and Medicare as the Baby Boom generation begins to retire, around 2010.”

In the great health care debate of 2009, that’s the kind of argument you’d expect to hear from a Republican politician. But the words were actually written by Ezekiel Emanuel, a health-care advisor at the Office of Management and Budget, and the brother of Rahm Emanuel, the White House Chief of Staff.

Ironically, Dr. Emanuel now stands accused of favoring some sort of death panels himself, thanks in part to a paper he recently co-authored, which argues that the scarcest medical resources (emergency vaccines, say, or donated organs) should be provided to younger, healthier patients before they’re given to the aged and infirm. His critics have seized on the paper to suggest that Emanuel — and by extension, the Obama administration — might support applying age and health-based rationing to medical treatment in general.

Yet the conservatives pillorying him, unjustly , as a “deadly doctor” could just as easily be quoting him. Twelve years later, Emanuel’s Atlantic essay remains a lucid case for the existence of a slippery slope, especially under government-managed health care, to some sort of death-by-bureaucrat.

Just because Ezekiel Emanuel and Sarah Palin agree that a slope exists, however, doesn’t mean that America will slip down it.

In a more cost-conscious culture, there’s no question that physician-assisted suicide could lead to a particularly sinister form of rationing. The European experience offers plenty of cautionary tales — from the spread of less-than-voluntary euthanasia in the suicide-accepting Netherlands, to the recent controversy over Great Britain’s “Liverpool Care Pathway,” whose supposedly-merciful approach to dying patients may involve withdrawing care before their death is actually certain.

But the American way of death is different. Our move toward physician-assisted suicide springs from the same quest for mastery over mortality that leads us to spend nearly twice as much on health care as any other developed nation. And our instincts run so strongly toward unlimited spending that it’s much easier to imagine the government going bankrupt paying for extreme life-saving procedures than it is to imagine a suddenly cost-conscious bureaucracy pressuring doctors to administer lethal overdoses.

It sounds paradoxical to link the desire for unlimited medical treatment to the desire for physician-assisted suicide. But the idea that there’s a right to the most expensive health care while you want to be alive isn’t all that different, in a sense, from the idea that there’s a right to swiftly die once life doesn’t seem worth living.

In each case, the goal is perfect autonomy, perfect control, and absolute freedom of choice. And in each case, the alternative approach — one that emphasizes the limits of human agency, and the importance of humility in the face of death’s mysteries — doesn’t mesh with our national DNA.

There are many good reasons to oppose assisted suicide. It transforms a healing profession into a killing profession. It encourages relatives to see a loved one’s slow death as a problem to be solved, rather than a trial to be accepted. And as Emanuel noted in his 1997 essay, its “beneficiaries” are far more likely to be suffering from psychological distress than unbearable physical pain.

But in the profligate, Promethean United States, it probably won’t lead to rationing-by-euthanasia. It’s just as likely to become one more “intervention” that we insist every health insurance plan should cover — on our way, perhaps, to a rendezvous with fiscal suicide.

    A More Perfect Death, NYT, 7.9.2009, http://www.nytimes.com/2009/09/07/opinion/07douthat.html

Clinton’s Health Defeat

Sways Obama’s Tactics

September 6, 2009
Th New York Times
By JACKIE CALMES

WASHINGTON — Before Congress’s August break, the chief aides to Senate Democrats met in a nondescript Senate conference room with three former advisers to President Bill Clinton. The topic: lessons learned the last time a Democratic president tried, but failed disastrously, to overhaul the health care system.

With the aides as divided as their bosses on President Obama’s signature initiative, their typically tedious weekly session turned hotly spirited. So the Clinton White House veterans — John D. Podesta, a former senior adviser; Steve Ricchetti, a Congressional lobbyist; and Chris Jennings, a health policy aide — homed in on their ultimate lesson of the failure 15 years ago, that there is a political cost to doing nothing.

In 1994, Democrats’ dysfunction over fulfilling a new president’s campaign promise contributed to the party’s loss of its 40-year dominance of Congress. Now that memory is being revived, and it is the message the White House and Congressional leaders will press when lawmakers return this week, still divided and now spooked after the turbulent town-hall-style meetings, downbeat polls and distortions of August.

Republicans early on united behind the lesson they took from the past struggle, that they stand to gain politically in next year’s elections if Democrats do nothing. But the Democrats’ version similarly resonates with all party factions, giving Mr. Obama perhaps his best leverage to unify them to do something. In now-familiar financial parlance, this one is “too big to fail.”

“Certainly if you undercut your own leadership, that shortens the honeymoon and could possibly even cripple the administration,” said Representative Jim Cooper of Tennessee, a Democrat and member of the fiscally conservative Blue Dog Coalition who opposed the Clinton plan and has criticized current efforts. “And no one here wants that.”

That 15-year-old lesson underscores how much the Clinton debacle has defined Mr. Obama’s drive for his domestic priority from the beginning, providing a tip sheet for what not to do. Even Mr. Obama’s decision to address a joint session of Congress on Wednesday night to jumpstart his health initiative left some aides wary, given the inevitable parallels with Mr. Clinton’s September address 16 years ago to introduce his ill-fated plan.

Before Mr. Obama was elected, advisers began debriefing Clinton veterans to draft “lessons learned” memorandums. According to interviews with more than a dozen participants in the debates then and now, those lessons have helped the president’s proposals progress further through Congress’s committees than the plan advocated by Bill and Hillary Rodham Clinton did. All the while, the administration has held the tentative support of powerful associations for doctors, nurses, seniors, hospitals, drug makers and, as Mr. Obama recently put it, “even the insurance companies,” which did the most to defeat the Clintons.

But Mr. Obama’s performance has also raised questions about whether the administration has drawn too much from some lessons and underestimated some hurdles unique to today’s battle.

The losses of two important confidants — former Senator Tom Daschle’s withdrawal as Mr. Obama’s choice for health and human services secretary amid a tax controversy, and Senator Edward M. Kennedy’s long illness and death — have been “incalculable” setbacks for pushing legislation through Congress, said a top aide to Mr. Obama. Neither the House nor the Senate met his deadline for passing legislation before August.

Yet even if the administration did everything right, drafting legislation this complicated is never going to be easy.

“That period of defining the issue and developing the pieces and the resources to actually legislate is a relatively smooth river,” said Charles Kahn, an insurance industry lobbyist in the 1990s who now represents for-profit hospitals. Once Congress starts filling in the details, he continued, “then you hit the rapids. And they’ve hit the rapids now.”

Mr. Obama has two disadvantages that Mr. Clinton did not. The deep recession has stoked concerns about deficits, and moderate Republicans willing to cut deals are nearly extinct.

But Mr. Obama also has advantages flowing from his election by a 53 percent majority — the highest number for a Democrat since 1964 and 10 percentage points more than Mr. Clinton won. Congressional Democrats, while hardly of one mind, are still more unified behind him than they were behind Mr. Clinton, committee leaders are more respectful and Mr. Obama is richer in campaign money and grass-roots support.

Add to that, Democrats say, the benefits of the lessons of the Clinton era:

Lesson 1: Failure Is Not an Option.


As the Clinton-era veterans attest, and the Obama team is now arguing to Democrats, voting for a health bill might be difficult politically, but doing nothing at this point would be worse.

“When a party fails to govern, it fails electorally,” said Rahm Emanuel, a former Clinton aide who now is Mr. Obama’s chief of staff.

 

Lesson 2: Know your audience — insured taxpayers.

Even as a candidate, Mr. Obama showed that he was trying to avoid his predecessor’s mistakes.

Mr. Clinton had promised universal coverage, emphasizing care for the uninsured — roughly 37 million then, now 46 million. That left the many more Americans with insurance, however flawed, to wonder what the complex and initially costly changes would mean for them.

By the 2008 presidential campaign, Mr. Obama’s Democratic rivals, including Mrs. Clinton, were again promising universal coverage. Mr. Obama never did, except for children. He emphasized that insured Americans would see lower costs, more choices and better coverage.

Then, as now, he more often cited as potential beneficiaries not the mostly poor uninsured but the working and middle classes, people like his mother, who had insurance but fought her carrier all the while she was dying of cancer. When he spoke of covering the uninsured, Mr. Obama argued that doing so would also help the insured because hospitals, doctors and insurers would no longer have to pass on unpaid expenses in higher premiums and prices to paying patients.

But for all his efforts, when Congress began writing legislation and its analysts priced the various proposals this summer, the sticker shock drew taxpayers’ attention — just as in Mr. Clinton’s time — to the main expense, which was covering the uninsured. Democrats’ plans would expand Medicaid for the poor and subsidize both low-income workers buying insurance and small businesses seeking coverage for employees.

So, just as in 1994, “people are trying to figure out what they’re getting aside from additional costs” for taxpayers, said Howard Paster, Mr. Clinton’s chief Congressional lobbyist. “At the end of the day, most people will complain about their insurance company, will grumble about costs, but they’re ultimately satisfied with the health care they’re getting.”

Some Democrats compare the current moment to the early spring of 1994. The insurance lobby’s “Harry and Louise” commercials against the Clinton plan had come to embody the angst of the insured middle-class. Democratic lawmakers were panicky. “It became irrevocably lost,” said Mr. Daschle, who as a Senate Democratic leader was at the center of that debate.

Mr. Obama has more recently been spotlighting features that will appeal to the insured middle class, the proposed “consumer protections” that will not cost taxpayers. Among them, companies must cover anyone regardless of medical history, cannot drop policyholders who become sick and must cover preventive care like mammograms.

 

Lesson 3: Move before the honeymoon ends.

This is one of the lessons Mr. Obama may have learned too well.

In 1993 Mr. Clinton delayed his push for a health care bill until late that first year, by which time he was weakened by other legislative battles and personal controversies. Mr. Obama, by contrast, moved quickly to exploit his post-inaugural momentum, amid the demands of the worst economic crisis since the Depression.

But some say he moved too quickly, setting the August deadline for the House and the Senate to each pass their bills, then appearing to take a loss when neither acted.

“The biggest mistake Obama made, and I want him to succeed, is trying to rush it,” said former Senator Bob Dole, who as Republican leader in the 1990s first negotiated with Mr. Clinton and then led the opposition. “Why put some arbitrary deadline on a piece of legislation that’s going to affect every American?”

Meanwhile, Mr. Obama, like Mr. Clinton, has lost some leverage and luster as his poll numbers have weakened.

 

Lesson 4: Leave the details to Congress.

Mr. Obama got a faster start than Mr. Clinton by not repeating his mistake of trying to write the law for the lawmakers. The Clintons’ secretive labors on a 1,342-page bill cost nine months and stoked resentment among Congress’s proud Democratic committee barons, who felt left out.

Mr. Obama went to the other extreme. He produced no plan, only fairly specific directives. He said he wanted to create “exchanges” offering private insurance plans and a public option. He called for insurance subsidies for individuals and small businesses. And he advocated changes in Medicare and Medicaid payments to give the health industry incentives to control costs and improve care.

While Congressional Democrats welcomed the partnership, some now wonder if the president did not “overlearn the lessons of 1994 by giving Congress too much leeway,” as Mr. Cooper of the Blue Dog Coalition put it.

Administration officials counter that the president’s initiative would not otherwise have gotten as far as it has, with bills passed in four out of five committees, if he had not initially deferred to Congress. But with the fifth and most crucial panel, the Senate Finance Committee, still struggling for a bipartisan alternative, the president will most likely serve notice with Wednesday night’s speech that he is taking the lead, with what aides call a “more prescriptive” legislative blueprint for Democrats to get behind.

“They’re not going to get the ball over the finish line without his direct help and intervention,” said Mr. Podesta, the former Clinton lieutenant, who headed Mr. Obama’s post-election transition.

 

Lesson 5: Co-opt the opposition.

In a lesson that holds some irony for Mr. Obama given his campaign against special interests, he has mostly rejected the Clintons’ industry-bashing populism. That has helped keep powerful groups at the table, to prevent their allying against him as they did against Mr. Clinton.

The president privately reached early deals with the for-profit hospital group represented by Mr. Kahn, who led the “Harry and Louise” campaign, and with the drug manufacturers lobby. The industries agreed to accept roughly $230 billion in reduced Medicare and Medicaid payments over 10 years to help offset the cost of a health care bill, and the White House committed to support the deals through the legislative process despite liberals’ demands for bigger concessions.

For older Americans, the administration agreed with the advocacy group AARP that any bill would eliminate the gap in Medicare coverage of prescription drugs.

“People have underestimated the strategic value of some of these alliances in terms of being able to keep this thing going,” said a former Clinton aide, who asked not to be identified because he now lobbies for several industries.

The Obama team’s outreach extended even to the insurance industry, until the administration began going after it last month to shore up public support. White House officials remain divided over the tactic, with some fearful of provoking the deep-pocketed industry’s fury — as the Clintons did.

 

Lesson 6: Take what you can get.

What optimism remains among Democrats stems from their belief that Mr. Obama, unlike the Clintons, will take half a loaf and declare victory, and that most Democrats, mindful of 1994’s election debacle, will go along.

In his 1994 State of the Union address, Mr. Clinton famously waved a pen and threatened to veto any bill that did not “guarantee every American” private health insurance. Even an aide who recommended that uncompromising signal, Paul Begala, now says it was a mistake. Others have said the White House forfeited a chance to compromise with Mr. Dole and other Senate Republicans.

The question for Mr. Obama is whether he will have any Republicans with whom to compromise. More likely, he will have to mediate between the liberals and conservatives in his own party.

    Clinton’s Health Defeat Sways Obama’s Tactics,n NYT, 6.9.2009, http://www.nytimes.com/2009/09/06/health/policy/06lessons.html

Young Adults

Swelling Ranks of Uninsured

September 5, 2009
The New York Times
By ANDREA FULLER

WASHINGTON — Some of the difficult financial choices facing uninsured Americans — whether to go to a hospital or tough out an illness, whether to pay the rent or pay doctor bills — confront young people who not that long ago had to worry only about buying gasoline or paying a cellphone bill.

The age group of people 19 to 24 years old has the highest percentage of uninsured individuals, according to the Kaiser Family Foundation. Thirty percent of them did not have health insurance in 2007, a number almost certainly driven higher in an arid job market.

An additional 26 percent of people 25 to 34 years old were uninsured, Kaiser found. As a whole, polls have found that adults under 34 are more supportive than others of President Obama’s drive to overhaul health care, though their views are hardly unanimous.

For now, some of them are without insurance by choice, gambling that their youth will keep them healthy. But others, already dealing with medical issues, say that affording medical care is a near impossibility because they either have no insurance or have inadequate coverage.

For a 23-year-old woman who graduated from Duke University in 2008, her efforts to break into the film industry mean a string of internships, none providing insurance. Nor can she afford insurance with her earnings from the jobs she has taken to support herself, including a position as a nanny and as a part-timer at a boutique.

But the woman, who asked not to be identified to keep her medical condition private, has HPV, a virus linked to cervical cancer. An annual pap smear and a colposcopy, a follow-up procedure to check for cancer, cost her hundreds of dollars.

“Do I keep checking that or do I save some money?” she said. “Do I do what I’m supposed to do and pay for the next procedure? Do I opt out of it because I can’t afford it?”

For some, landing a steady job does not necessarily translate into insurance.

Kristy Weaver, 22, began working full-time as a certified nursing assistant at a nursing home in Crescent City, Fla., when she was 16. But Ms. Weaver said that the only insurance offered through her job “wasn’t worth what you paid for it.”

When Ms. Weaver was 11, doctors told her that she had ovarian cysts. Last year, a specialist told her the only way to eliminate the problem would be to remove her left ovary, an operation that she was told could cost $6,000 to $10,000. Unable to afford the surgery, she began taking heavy doses of birth control pills the doctor prescribed.

“All it did was make it worse,” said Ms. Weaver, who is now a staffing coordinator at the nursing home. Ms. Weaver now has insurance through her employer, and said she has to wait 12 months before consulting a doctor about the cysts or else the insurer could designate the problem as a pre-existing condition that will not be covered. She has six months to go.

“It’s a really throbbing pain,” Ms. Weaver said. “The first time I had an attack, I thought I was losing a baby. I couldn’t catch my breath. I was in bed for three or four days.”

Now, she is about $5,000 in debt from her medical bills.

“I can’t get a new car,” she said. “I can’t look at buying a house.”

Instead of racking up medical bills, other young people decide to forgo treatment completely.

Spencer Krasch, 19, had surgery last year for Wolff-Parkinson-White syndrome, a condition that causes his heart to beat rapidly, while covered on his father’s insurance. Now out of high school and working in a deli, he is uninsured and has discontinued routine check-ups.

But recently, when Mr. Krasch, who lives in Temple City, Calif., was helping his girlfriend move into her dorm at Pomona College, he felt as if he was having a stroke, which he said doctors told him could be a complication of the surgery.

“All of a sudden the whole left side of my body went completely numb,” he said. “My lips started twitching.”

But he refused to let his girlfriend’s parents call an ambulance.

“That would have been way too expensive for me to pay for,” he said. Instead, Mr. Krasch waited until the symptoms subsided.

Even those who are in good health can quickly find themselves on the other side of the divide.

Josh Pavlacky, 23, knows that all too well. As a graduate of a top liberal arts college, Wesleyan University, with a bachelor’s degree in studio art, he expected to find nonprofit work. Instead he is working as a dishwasher and running an art gallery out of his garage in Portland, Ore.

While in college, he was covered by the policy of his father, who works security at Costco. But now, he says, that coverage has ended and his family cannot afford to help him buy something else.

So when Mr. Pavlacky got hit by a car while biking in May, he decided that a hospital visit was out of the question. Instead of seeking treatment, he had friends bring him prescription painkillers they had left over from procedures like having their wisdom teeth removed.

“I was flipped over and fell on my back,” he said. “I had a bruise all down my leg and couldn’t walk for three days.”

Mr. Pavlacky says he supports the president’s health care overhaul, and wishes Mr. Obama had pushed a public plan forward himself instead of turning the negotiations over to Congress and “bringing everybody into the tent.”

Young people are split on how the president is handling health care, according to a Quinnipiac University poll released Aug. 5, though they are more supportive than other age groups. In the poll, 48 percent of those ages 18 to 34 said “disapprove” while 44 percent said they “approve.”

Still, 53 percent of that group said the president would do a better job at handling health care policy than Congressional Republicans, while 35 percent sided with the Republican lawmakers.

Ms. Weaver, who voted for Senator John McCain for president, says she worried that a health care overhaul could make taxpayers finance a system that does not work.

But she said she feels that politicians do not seem to understand what young people are going through.

“It’s the people who are trying to make a foundation for themselves,” she said. “It’s so difficult for younger people who are just now starting.”

    Young Adults Swelling Ranks of Uninsured, NYT, 5.9.2009, http://www.nytimes.com/2009/09/05/health/policy/05uninsured.html

Document Details Plan

to Promote Costly Drug

September 2, 2009
The New York Times
By GARDINER HARRIS

The pharmaceutical industry has developed thousands of medicines that have saved millions of lives, but it has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost.

No drug better demonstrates the industry’s salesmanship than Lexapro, an antidepressant sold by Forest Laboratories. And a document quietly made public recently by the Senate’s Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller.

The document, “Lexapro Fiscal 2004 Marketing Plan,” is an outline of the many steps Forest used to make Lexapro a success. Because of concerns from Forest, the Senate committee released only 88 pages of the document, which may have originally run longer than 270 pages. “Confidential” is stamped on every page.

But those 88 pages make clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors’ pockets and food into their mouths.

Frank Murdolo, a Forest spokesman, said the company was “aware” that its marketing plan was circulating around the Senate.

“We’re aware of it but I can’t give you any other comment on it,” he said.

In February, federal prosecutors in Boston announced a civil lawsuit against Forest claiming that the company illegally marketed both Lexapro and a closely related antidepressant, Celexa, for use in children and paid kickbacks to doctors to induce them to prescribe the medicines to children.

It is illegal to pay doctors to prescribe certain medicines to their patients. It is not illegal to pay doctors to educate their colleagues about a medicine. In recent years, federal prosecutors have accused many drug makers of deliberately crossing that line.

Lexapro was the sixth drug in a class of medicines that includes Prozac, Paxil, Zoloft, Luvox and Celexa. Forest licensed Celexa from Lundbeck of Denmark and introduced the medicine into the United States in 1998. But because Celexa’s patent life was relatively short, the company quickly developed a new version of Celexa by tinkering with the molecule in a way that is standard in the industry. The company called the new medicine Lexapro and introduced it into the United States in 2002.

Forest’s executives and paid consultants have long implied that Lexapro is superior to Celexa and other antidepressants. But the Food and Drug Administration did not require Forest to test this theory in any statistically valid way. The F.D.A. views the two medicines as so interchangeable that the agency recently approved Lexapro’s use in depressed adolescents based in part on the results of a study Forest conducted using Celexa.

Lexapro had $2.3 billion in sales in 2008 even though generic versions of Celexa and every other drug in the class sell for a fraction of Lexapro’s price. For example, a month’s supply of 5-milligram tablets of Lexapro costs $87.99 at drugstore.com, compared to $14.99 for a month’s supply of a generic version of Prozac. Forest has recently been raising the price of Lexapro to make up for a decline in its use.

Many doctors say they believe that Lexapro is the best antidepressant, so they prescribe the drug despite its cost.

It is impossible to unpack all of the reasons for these prescriptions, but some industry critics say one reason could be the money doctors make from Forest. Psychiatrists make more money from drug makers than any other medical specialty, according to analyses of payment data. And Forest gives more money and food to doctors than many of its far larger rivals. Vermont officials found that Forest’s payments to doctors in 2008 were surpassed only by those of Eli Lilly, Pfizer, Novartis and Merck — companies with annual sales that are five to 10 times larger than Forest’s.

Forest’s 2004 plan for marketing Lexapro offers detailed information about how the company planned to direct this money to doctors.

Under “Rep Promotional Programs,” the document said the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers in one year.

“These meetings may be large-scale dinner programs with a slide presentation, small roundtable discussions or one-on-one advocate lunches,” the document states.

Under “Lunch and Learns,” the company intended to spend $36 million providing lunch to doctors in their offices. “Providing lunch for a physician creates an extended amount of selling time for representatives,” the document states.

An entire section of the marketing plan, titled “Continuing Medical Education,” outlines how the company intended to use educational seminars for doctors to teach them about Lexapro. The Senate’s Special Committee on Aging held a hearing in July on whether industry funding of medical education classes leads to tainted talks.

“At our recent hearing we asked the question, ‘Is the line between medical education and marketing blurred?’ ” said Senator Herb Kohl, a Democrat from Wisconsin who is chairman of the committee on aging. His panel was given the Lexapro document by the Senate Finance Committee, which has long been investigating drug maker marketing efforts. “These documents show that for these companies, there is no line,” Mr. Kohl said.

    Document Details Plan to Promote Costly Drug, NYT, 2.9.2009, http://www.nytimes.com/2009/09/02/business/02drug.html

Forty Years' War

Taking Risk for Profit,

Industry Seeks Cancer Drugs

September 2, 2009
The New York Times
By ANDREW POLLACK

SAN DIEGO — Pfizer’s fortunes in the past were built on cardiovascular drugs, like the cholesterol buster Lipitor and the blood pressure pill Norvasc.

But the future of Pfizer, the world’s largest pharmaceutical company, may rest in a cluster of buildings on a bluff not far from the Pacific Ocean. It is here that Pfizer has amassed about 1,000 researchers for an all-out effort to develop drugs for cancer, a disease the company once largely ignored.

Virtually every large pharmaceutical company seems to have discovered cancer, and a substantial portion of the smaller biotechnology companies are focused on it as well. Together, the companies are pouring billions of dollars into developing cancer drugs.

Two industry trends are driving the push. Recent scientific discoveries have suggested new targets for cancer drug researchers to attack. And as drug companies see profits beginning to wane from mainstays like Lipitor, the high prices that cancer drugs can command have become an irresistible lure.

About 860 cancer drugs are being tested in clinical trials, according to the pharmaceutical industry’s main trade group. That is more than twice the number of experimental drugs for heart disease and stroke combined, nearly twice as many as for AIDS and all other infectious diseases combined, and nearly twice as many as for Alzheimer’s and all other neurological diseases combined.

But for all the industry’s spending and effort, only a trickle of new cancer drugs make it to market. Last year there were two, and this year there has been only one.

And even some of those drugs offer only a few months at most of extra life or tumor stabilization despite prices that often reach thousands of dollars a month. The drug Tarceva, which costs about $3,500 a month, was approved as a treatment for pancreatic cancer because it improved survival by 12 days.

The battle to treat cancer has become, as a commentary in a leading journal put it, a “grinding war of the trenches.”

Why? Experts say the same factors that attract drug companies to the cancer business help explain the slow progress.

One reason is scientific. Studies are rapidly revealing the genetic changes in cells that cause cancer and spur its growth. That is providing drug companies with dozens of molecules, or “targets,” that drugs could block.

But those same studies have shown that cancer is devilishly complicated. There are so many aberrant molecules in a tumor that blocking just one or two is like trying to stop all traffic in Manhattan with a roadblock at a single intersection.

Tumor cells, like bacteria, can develop resistance to drugs. Some experts believe that drugs that kill most tumor cells do not affect cancer stem cells, which can regenerate the tumor.

And even two people with breast cancer, or two people with lung cancer, might have two very different diseases on the molecular level, so a drug that works for one might not work for the other.

“Cancer is not a single disease,” said Robert A. Weinberg, a cancer biologist at the Whitehead Institute and the Massachusetts Institute of Technology. “It’s really dozens, arguably hundreds of diseases.”

The other reason for the drug makers’ interest is financial. Patients are often desperate, and insurers risk outrage by denying payments for a cancer drug, even if the odds say it will have little benefit. That has allowed pharmaceutical companies to charge thousands of dollars a month for cancer medicines. Such prices can make drugs for even rare cancers, or drugs that do not work very well, into big moneymakers.

Take Erbitux, developed by ImClone Systems, which costs $10,000 a month. A study in Canada showed that as a last-ditch treatment for colorectal cancer, Erbitux lengthened lives by an average of about one and a half months compared with not treating the cancer at all. Using the price of the drug in the United States and the average length of treatment, the extra cost per patient was about $50,000.

Erbitux, which is also approved to treat head and neck cancers, recorded global sales of $1.6 billion last year, higher than all but about 70 other drugs. Last year, as part of the industry scramble into cancer drugs, Eli Lilly & Company outbid Bristol-Myers Squibb to acquire ImClone for $6.5 billion.

In 1998, there were only 12 cancer drugs on the list of the world’s 200 medicines with the highest sales, compiled by the trade magazine Med Ad News. Taxol, No. 21, was the only cancer drug among the 30 drugs with sales of at least $1 billion.

The same list for last year contained 23 cancer drugs among the top 200 — and three in the top 10. Of the 126 drugs with $1 billion in sales, 20 were for cancer.

Cancer drugs have been the biggest category of drugs in terms of sales worldwide since 2006 and in the United States since 2008, according to the market researcher IMS Health.

Such money attracts companies. “Cancer is such an emotional issue that the free market doesn’t work like it does for bicycle wheels and umbrellas,” said Robert L. Erwin, a biotechnology industry executive who heads the Marti Nelson Cancer Foundation, a patient advocacy group. “As long as the health care system will pay the price, the money will flow in that direction.”

But Mr. Erwin and some other experts say that is not always a good thing for patients because it can set the bar too low for drug companies.

“As long as the marketplace does not distinguish between modestly effective drugs and dramatically effective drugs, there won’t be an incentive to shift resources to a greater emphasis on a larger benefit,” said Dr. Neal J. Meropol, an oncologist at the Fox Chase Cancer Center in Philadelphia who has been studying drug prices.

Many executives dispute this, saying they would produce drugs offering bigger gains if they knew how. But they must balance their portfolio of experimental drugs between long shots and some drugs that have a better chance of making it to market and sustaining the enterprise.

“If you always swing for home runs, you strike out a lot,” said George A. Scangos, chief executive of Exelixis, a biotechnology company with 11 cancer drugs in clinical trials. “It’s not the companies’ profit motives,” he said. “It’s largely the difficulty of hitting home runs.”

With health care costs rising, there is new pressure on companies to be more selective in drugs they develop. Some experts now talk about “financial toxicity” as a side effect of cancer drug treatment, along with nausea and hair loss.

“A question is how the system can tolerate 400 new drugs on the market, all at the same price” of $50,000 a year, said Dr. Lee Newcomer, senior vice president for oncology at United Healthcare, a big insurer.

Such cost pressures, and the fact that only a handful of cancer drugs get to market each year, mean the big investments now being made into cancer drugs are likely to turn sour for many companies.

“It’s the biggest bubble you’ve ever seen,” said Dr. Mark Ratain, an oncologist at the University of Chicago.

But Pfizer is counting on cancer to help save the company. It hopes to reach $11 billion in sales of cancer drugs by 2018. That would be more than four times the category’s sales last year of $2.5 billion, which represented only 5 percent of Pfizer’s revenue.

Cancer was once unattractive for big pharmaceutical companies like Pfizer. There were relatively few patients with any one type of cancer, and they died fairly quickly. By contrast, there were millions of patients with chronic diseases like hypertension who would take drugs for life.

Indeed, the three main cancer drugs Pfizer now sells came to it with its 2003 acquisition of a rival, Pharmacia, a deal done mainly to acquire the arthritis drug Celebrex.

But there are now many good cardiovascular drugs. Lipitor, the world’s best-selling drug, will lose patent protection in 2011, and Pfizer failed to develop a successor.

So Pfizer is scaling back cardiovascular research and has made cancer drugs one of its six focus areas. About 20 percent of Pfizer’s more than $7 billion in research and development spending is on cancer, and 22 of the roughly 100 drugs in clinical trials are cancer drugs.

“I’ve taken a lot of personal interest in this business unit,” said Jeffrey B. Kindler, Pfizer’s chief executive. “We think we are positioned to be a top leader in oncology.”

Cancer research is concentrated here in San Diego, in a cluster of buildings once owned by one of the many biotechnology companies in the region. Pfizer has tried to retain some of the looser culture of entrepreneurial start-ups, like Friday afternoon beer parties. The head of the site, Catherine Mackey, a transplant from Pfizer’s laboratories in Connecticut, has become an avid early-morning surfer.

The clinical trials for cancer are being overseen by Dr. Mace L. Rothenberg, an oncologist recruited this year from Vanderbilt University. He hopes Pfizer can develop those home-run drugs. “Having treated patients for 20 years,” Dr. Rothenberg said, “I know their needs are not for singles.”

The big thrust in cancer drug development for the last few years has been so-called targeted therapies. These drugs aim, so far with modest success, to block aberrant molecules in tumor cells while leaving normal cells unscathed.

But even most targeted therapies have limited impact. One reason is that most tumors are fueled by numerous, often redundant, genetic anomalies. That means that drugs with different targets need to be used in combination. But combinations increase both the costs and side effects of therapy. And it is difficult to test two experimental drugs in combination because the regulatory system is geared to assessing a single drug at a time.

Another reason is that tumors differ among people. Dr. Bert Vogelstein, a cancer geneticist at Johns Hopkins, said a typical tumor might have 50 to 100 genetic mutations. But two patients with the same type of cancer might have only five mutations in common.

So even though a drug might work well for patients whose tumors have a particular mutation, when the drug is used for a broader population, it shows only a small effect.

One solution is to try to determine which patients should get which drug based on the genetic profile of the tumor.

Pfizer is moving in that direction. It plans soon to start a late-stage clinical trial of a drug for lung cancer. But the only patients in the trial will be from the 5 percent or so of lung cancer patients with a mutation in a gene called A.L.K.

“What we’re looking for,” said Dr. Rothenberg of Pfizer, “is not a small benefit in a large group, but a larger benefit in a smaller group.”

For now at least, making the ballpark smaller may be the industry’s best chance to hit home runs.

    Taking Risk for Profit, Industry Seeks Cancer Drugs, NYT, 2.9.2009, http://www.nytimes.com/2009/09/02/health/research/02cancerdrug.html

Clinic Fills a Need but Faces Failure

September 2, 2009
The New York Times
By KEVIN SACK

MILWAUKEE — Like many low-income neighborhoods, the north side of Milwaukee has seen a gradual depletion of its primary care doctors over the last two decades. One by one, they have retired or surrendered to financial reality, rarely to be replaced.

At the few remaining practices, the wait for an appointment can make it almost purposeless to seek one. When Martha Brown’s 3-year-old daughter, Loverree, woke up with a runny nose last Thursday, her doctor’s office told her it would be a week. “I couldn’t wait,” Ms. Brown said. “I had to see what was wrong with my baby. I think she’s got an infection.”

Rather than heading to an emergency room, Ms. Brown took her three children to the Milwaukee Immediate Care Center, a small nonprofit clinic that has treated the north side’s largely African-American community since 1986. The clinic, which keeps hours at night and on weekends, is the only full-time operation in the neighborhood that provides urgent care, luring patients with a sign that reads, “When You Need a Doctor Today.”

Ms. Brown’s decision made good sense, not only for her but for the state and federal taxpayers who support her health coverage through Wisconsin’s Medicaid managed care program. But whether the option will remain available is an open question.

The clinic has teetered on the brink of insolvency for years, battered by foreclosure filings, delinquent tax claims, building code violations and the loss of contracts with two major H.M.O.’s. It has had to cut its hours in half, significantly reduce its medical staff and mothball its X-ray equipment.

Patient visits have dropped to about 7,000 a year from 15,000 three years ago, before basement flooding and a leaky roof prompted the city to shut the clinic for three months. The doors stayed open this month, said its president, Perry Margoles, only because a board member provided a $10,000 loan.

It might seem the health care legislation being written in Washington, with its emphases on primary care, lowering costs and improving access, would provide answers for clinics like Milwaukee Immediate Care. But Mr. Margoles thinks things may be too far gone in his clinic’s neighborhood.

“We’re having a meltdown approaching — to use an engineering term — a catastrophic failure for much of what remains of the health care infrastructure for the northern half of the city,” Mr. Margoles said.

Yes, he said, covering more of the uninsured would help his bottom line, which has been red in each of the last two years. But the bigger problem, he said, is the below-cost reimbursement provided by Medicaid, which insures three-fourths of the clinic’s patients. For a typical office visit for which the clinic charges $75, BadgerCare Plus, as Wisconsin’s Medicaid program is known, pays $49.

Dr. Syed H. Hasnain, the clinic’s lead physician, said more was needed than simply luring medical students into primary care with grants and loan forgiveness programs. “There has to be some parity between commercial insurance and Medicaid,” Dr. Hasnain said. “Common sense dictates that otherwise, who would want to work with public insurance recipients?”

The clinic often finds itself dealing with conditions like advanced hypertension and diabetes because patients without adequate insurance may defer care. But because Mr. Margoles has never tried to transform the clinic into a federally qualified health center, it is not eligible for the higher reimbursements paid to those centers. It also is not eligible for the billions of dollars allocated to the centers in the stimulus package, or the even larger increases that may be included in a health care bill.

For Mr. Margoles, a 65-year-old nonpracticing lawyer, the stress of dodging bankruptcy may be taking its toll. Three weeks ago, he said, he began having chest pains. Dr. Hasnain diagnosed the spasms as signs of coronary artery disease and recommended he go to an emergency room.

Mr. Margoles would not go. He is uninsured. He said that since opening the clinic he has deferred his $100,000 annual salary, surviving instead on modest rental income from property he owns and the generosity of family members. Although he is old enough for Medicare, the salary deferral has meant he has not paid enough into the system to qualify for benefits.

“I can’t afford to go to the emergency room or the hospital,” he said. “I’m not going to go bankrupt to get care I can’t afford.”

Because any health care deal is certain to preserve the private insurance system, Mr. Margoles said it would do little to solve his biggest headache — the refusal of two health maintenance organizations to renew their contracts when the clinic reopened in 2007.

Mr. Margoles accused the insurers of paying him back for complaining previously to the state about their billing and claims practices.

One of the companies, UnitedHealthcare of Wisconsin, said in a statement that it declined to contract with the clinic “after thorough consideration” and “with a consistent emphasis on providing access to quality health care for our members.” A spokeswoman for Centene Corporation, the parent group of the other insurer, Managed Health Services, did not respond to requests for comment.

Jason A. Helgerson, the state Medicaid director, said he had discussed the decisions with both insurers and found no evidence of retribution. Mr. Helgerson said he had no authority to force an insurer to contract with a particular provider.

“In both cases, they raised serious concerns about his business practices and were very opposed to signing a contract with him,” Mr. Helgerson said. “I know that in general the H.M.O.’s are eager to have as many providers in their networks as they can. It’s a rare circumstance for this to happen.”

Mr. Margoles has at times considered trying to convert his clinic into a federally qualified health center but is convinced that the move would be opposed because of its proximity to one of the four centers already in Milwaukee.

Senator Bernard Sanders, a Vermont independent who has led the effort to expand community health centers, said there was no money for noncertified clinics in the bills now circulating on Capitol Hill. But Mr. Sanders said he recognized the needs of clinics like the one in Milwaukee.

“I’m well aware there are people trying to do the right thing,” he said, “and to let these clinics fall by the wayside would be a mistake.”

 

Next: A profile of a young woman in San Diego
who has received two kidney transplants.

Clinic Fills a Need but Faces Failure, NYT, 2.9.2009, http://www.nytimes.com/2009/09/02/health/policy/02clinic.html