HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, January 31, 2009

Unpaid Taxes Delay Daschle

The New York Times' Robert Pear discusses some of Tom Daschle's tax issues that might disrupt plans for his confirmation as Secretary of Health and Human Services.  He writes,

President Obama’s pick for secretary of health and human services, Tom Daschle, filed amended tax returns and paid more than $100,000 in back taxes on Jan. 2, administration officials said on Friday. (Related news article.)  Mr. Daschle concluded that he owed the taxes for free use of a car and driver that had been provided to him by Leo Hindery Jr., the founder of a private equity firm known as InterMedia Advisors, the officials said.

Mr. Daschle was chairman of the firm’s advisory board. In a financial disclosure statement filed this month with the Office of Government Ethics, Mr. Daschle reported that he had received large amounts of income from InterMedia, including more than $2 million for consulting and $182,520 in the form of “company-provided transportation.” The belated tax payments help explain delays in the confirmation of Mr. Daschle, a former Senate Democratic leader who had been expected to win swift approval from the Senate. . . .

The official said that Mr. Daschle’s failure to pay the taxes was “a stupid mistake,” but should not derail the nomination. The confirmation of Treasury Secretary Timothy F. Geithner was held up only briefly following the disclosure that he had failed to pay more than $34,000 in taxes owed to the federal government. . . .

January 31, 2009 | Permalink | Comments (0) | TrackBack (0)

Friday, January 30, 2009

Fertility Treatments Under Scrutiny Again

I am sure that most of you heard about the successful births of octuplets last week.  The birth of so many children at one time does raise some, ok many, issues.  The LA Times reports,

Even as the birth of octuplets at Kaiser Permanente Bellflower Medical Center drew attention and applause from around the country, questions arose Tuesday about whether the mother's doctors did enough to prevent such a risky pregnancy.

The chances that the eight babies born Monday were conceived naturally are infinitesimal, infertility specialists and doctors in maternal-fetal medicine say. Today's reproductive experts have the tools and the know-how to avoid such high-risk pregnancies -- and often try desperately to do so.

"When we see something like this in the general fertility world, it gives us the heebie-jeebies," said Michael Tucker, a clinical embryologist in Atlanta and a leading researcher in infertility treatment. Tucker added that in his opinion, "if a medical practitioner had anything to do with it, there's some degree of inappropriate medical therapy there." . . .

The American Society for Reproductive Medicine and the American College of Obstetricians and Gynecologists say "doctors should be making efforts to curb these higher-order multiple gestations," said Dr. Geeta Swamy, an assistant professor of obstetrics and gynecology at Duke University. "But it really is still up to the individual physician. There aren't any laws or legal ramifications to it."

The babies could have been conceived through in vitro fertilization, in which eggs and sperm are combined in the lab and a specified number of the healthiest-looking embryos are transferred to the uterus. That scenario seems unlikely because fertility doctors are asked to adhere to strict guidelines that limit the number of embryos transferred. As a result, higher-order multiple births resulting from in vitro fertilization are uncommon.

A more likely scenario is that the mother of the octuplets received infertility drugs in a procedure called controlled ovarian hyperstimulation. The treatment, which is typically used to achieve pregnancy in women who do not ovulate, stimulates the ovaries to produce a number of eggs. As the eggs near maturity, the patient usually has artificial insemination.  An oral drug, clomiphene, can be used to stimulate the release of one or two mature eggs. But more powerful, injectable medications may produce eight to 10 mature eggs, said Dr. David Diaz, medical director of West Coast Fertility Centers in Orange County.  "That's the most common way these higher-order multiples occur," he said.

Some patients with infertility problems opt to try controlled ovarian hyperstimulation instead of in vitro fertilization because it is far less expensive -- about $2,000 to $3,000 instead of $10,000. Kaiser Permanente does not cover in vitro fertilization for its members. Although the octuplets were born in a Kaiser hospital, it's not known whether the mother is a Kaiser member.  Ovarian stimulation is far less controllable than in vitro fertilization, Swamy said, "because you can't control how many embryos you put back."

Even so, doctors typically go to great lengths to monitor treatments involving infertility drugs, Diaz said. If tests show too many eggs have been stimulated, doctors often will not follow through with a second medication that releases the eggs. They can also drain some of the follicles to reduce the number of eggs released.

If patients choose to proceed with the treatment -- even facing the potential of a large number of eggs being released -- they can later abort some of the embryos if a higher-order pregnancy occurs. Many patients dislike this practice, called selective reduction, said Dr. Harold Henry, director of maternal-fetal medicine at Kaiser Permanente. Some have religious or ethical objections to aborting any of the fetuses; others don't want to risk losing the entire pregnancy.

Infertility experts generally try to prevent multiple births because of the myriad potential health problems for mother and babies and because such births consume enormous financial resources for hospitals, health insurers and families . . . .

January 30, 2009 | Permalink | Comments (0) | TrackBack (1)

Senate Passes SCHIP

The New York Times reports on the Senate's passage of SCHIP.  Robert Pear writes,

The Senate passed a bill on Thursday to provide health insurance to more than four million uninsured children, as a newly empowered Democratic majority brushed aside Republican objections.  The vote was 66 to 32, with nine Republicans joining Democrats to support the bill.

President George W. Bush twice vetoed similar legislation. But President Obama is eager to sign the bill as a step toward providing insurance for all children and eventually all Americans.

The Senate debate showed the outlines of what promises to be a much larger political fight over universal coverage. While Democrats championed expansion of the child health program, many Republicans, including Senator John McCain of Arizona, said they worried that it was part of a long-term effort to replace private health insurance with government programs.  The House passed a nearly identical bill two weeks ago, by a vote of 289 to 139, with 40 Republicans joining nearly all Democrats in support of the measure. . . .

One of the most significant sections of the child health bill would allow states to use federal money to cover children and pregnant women who are legal immigrants. Under existing law, legal immigrants are generally barred from Medicaid and the State Children’s Health Insurance Program for five years after they enter the United States.  “The bill would end an inequity that we have been trying to eradicate for more than a decade,” said Jennifer M. Ng’andu, a health policy specialist at the National Council of La Raza, a Hispanic rights group.

The Congressional Budget Office said the bill would enable states to cover more than four million uninsured children by 2013, while continuing coverage for seven million youngsters. The bill would increase tobacco taxes to offset the increase in spending, estimated at more than $32 billion over four and a half years. . . .

January 30, 2009 | Permalink | Comments (0) | TrackBack (5)

Thursday, January 29, 2009

Food Safety - Peanuts and More . . .

Tom Laskawy, writes about the lack of food safety here in the United States, and informs us of all the problems we are having right now.  He states,

It's been a bad week for food safety. First, it was the peanut butter, then it was the High Fructose Corn Syrup and now it's deadly antibiotic-resistant staph bacteria (aka MRSA) in CAFO pigs (and their minders).  And of course, as Bill Marler - litigious scourge of the food industry - reminds us, we're continuing to lose the fight against E. coli.

Much has been written about the efforts to track down the sources of contamination. And invariably the companies involved quickly close the their doors (which is how we lost one of the largest ground beef distributors in the country virtually overnight and why the Peanut Corporation of America is no more). But what's truly worrisome is that in each case, the USDA and the FDA (who have joint responsibility for food safety) had information at hand about all of these problems. . . .

It's understandable then, that USDA chief Tom Vilsack is less concerned with creating whole new regulatory structures for food safety and more concerned with making the ones that we have actually work. But continuing to mix boosterism and regulation - as many of our federal agencies including the FDA and the USDA do - will inevitably lead to these kind of breakdowns. And though you can come up with laundry list after laundry list of changes to penalties, enforcement, inspections and agencies that would improve matters, the frequency and seriousness of each outbreak suggests good intentioned reform may not be enough.

That the output of one contaminated peanut processing plant could require the recall of hundreds of varied and unrelated products and could kill 8 and sicken over 400 in more than 40 states across the country suggests we may have reached the limits of consolidation in the food industry. You'd think that such centralization of food production would make regulation easier. Indeed, the ease of regulation, along with low cost, was one of the prime alleged advantages of consolidation. But we're seeing not just production failures, but the wholesale failure of the regulatory structures themselves. Well, food is cheap anyway.

   

January 29, 2009 | Permalink | Comments (0) | TrackBack (2)

Eliminating Waiting Period for Medicare

Harold Pollack writing at Ezra Klein's blog discusses another way to help stimulate the economy - elimination of the two-year waiting period for disabled people to receive Medicare.  He explains,

      

This waiting period goes back to 1972, when Congress expanded Medicare eligibility to include the disabled. Under current policy, people with disabilities must receive Social Security Disability Insurance (SSDI) for 24 months before becoming Medicare-eligible. Exceptions have been added for end-stage renal disease and ALS. Some states step in to fill the gap. Yet this policy imposes severe problems on many people. According to the Congressional Budget Office (CBO), roughly 1.8 million SSDI beneficiaries are now in the waiting period for Medicare coverage.  (See Option 19 in their huge report.)

There are policy-analytic arguments to support current policies—Medicare does not want to assume burdens rightfully borne by private insurers or to finance care for temporary disabilities. The program did not want to strengthen perverse incentives to remain uninsured. A nice Commonwealth Fund report by Stacy Berg Dale and James Verdier details these issues. (In one of those small-world moments, I was Verdier’s teaching assistance nearly two decades ago.) As we move into a world aspiring to universal coverage, increased protection for people with preexisting conditions, and perhaps even some flavor of individual mandate for insurance coverage, original arguments for the waiting period seem outmoded, and outweighed by the resulting human cost.

Berg and Verdier’s 2003 report is now a bit dated, but it remains the best single information source. Their work suggests that up to 400,000 uninsured people with serious disabilities might be helped by changes in this policy.

The National Multiple Sclerosis Society and pretty much every similar advocacy group have spoken out against the waiting period. Pending House and Senate bills propose to phase out the waiting period over the next decade and to grant more exceptions for people with life-threatening illnesses. The House version, HR 154, has 104 cosponsors. The Senate version, S2102, has 23 cosponsors. I am especially heartened that the issue is raised in Senator Baucus’s vaunted white paper on health reform.

CBO has sussed out various proposals to reduce or eliminate the waiting period. Eliminating the waiting period entirely would increase federal outlays by about $41 billion between 2010 and 2014, and would cost about $12 billion per year once it is fully implemented. This calculation reflects a shift in federal spending from Medicaid onto Medicare of about $32 billion between 2010 and 2019, because Medicaid plays an important role in filling the current gap. (This calculation nicely illustrates CBO’s essential role in getting complicated numbers right. Don’t try this at home.)

CBO doesn’t report the billions of dollars that states would save by reducing this Medicaid burden. My perilously rough calculation based on Dale and Verdier’s work suggests that states would save in the neighborhood of $2.4 billion annually, were SSDI recipients made immediately Medicare-eligible. . . .

January 29, 2009 | Permalink | Comments (0) | TrackBack (8)

Wednesday, January 28, 2009

Medicare Reform in the Stimulus Bill

The Wall Street Journal's Health Blog reports on some of the proposed changes in Medicaid currently being discussed as part of a stimulus bill. 

You might mistake the economic stimulus package slated for a House vote today for a health-reform bill, if weren’t sprinkled with some goodies for other sectors of the economy.  Take a look at the changes to Medicaid policy, in particular, the New York Times reports. If it becomes law, the bill would temporarily allow unemployed workers to qualify for Medicaid regardless of their income or assets. Medicaid is typically for the poor.

The bill also increases federal funding for Medicaid and subsidizes laid-off workers who are paying for Cobra insurance coverage through their former employers, NYT says. Here’s how the paper quotes the Congressional Budget Office on the costs: $87 billion to increase the federal share of Medicaid; $29 billion to subsidize private insurance and $11 billion to fund Medicaid for unemployed workers who wouldn’t otherwise qualify. . . . .

One casualty of congressional horsetrading is an expansion of contraceptive coverage under Medicaid, the WSJ reports. That one had been blasted by Republicans, and Democratic leaders late Tuesday agreed to remove it.

Meanwhile, on the health information-technology funding in the bill, National Public Radio caught up with John Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston. He argues that the $20 billion dedicated to increasing doctors’ use computers will create about 200,000 jobs .. . . .

 

January 28, 2009 | Permalink | Comments (0) | TrackBack (0)

Learning from Banks?

Slate.com's Zachary Meisel and Jesse Pines have a cautionary tale for health care workers and reformers from those who work in the banking industry.  They write,

The condition of the U.S. economy can be described generously as bleak. But while unemployment is on the rise and the Big Three automakers struggle to remain afloat, the business of making people well seems relatively insulated. While some discretionary health care sectors are not growing, such as LASIK eye procedures and plastic surgery that patients pay for out of pocket, most health care workers still have jobs and can afford the occasional $4 latte. 

But the health care industry is no oasis. The very problems that brought our country to its financial knees are still at work today in health care. It comes down to the disordered competition that exists in both the mortgage and health care industries.

If you pick up your college econ textbook, you'll read all about Adam Smith and how competition is fundamentally good. When companies compete, it results in a better product for the consumer: McDonald's competes with Burger King to make a better, cheaper hamburger. Problem is, in both the old, defunct mortgage business and current health care industry, the "invisible hand" fails to produce low-cost, high-quality, sustainable products.

In the mortgage industry, this competition failure produced the banking crisis. During the housing bubble, banks competed with one another to sell risky mortgages that had a high likelihood of default. Now, entire neighborhoods have been left nearly deserted because of waves of foreclosures. In health care, competition similarly fails to produce better community health. Instead of competing with one another for the best outcomes, providers compete for patients with the most profitable diseases. Hospital care for cancer and heart surgery makes more money than hospital care for diabetes, pneumonia, or mental health. While all these services get reimbursed, some bring in more cash than others—in effect, cancer care is like gold while diabetes is like silver.

As a result, form follows finance: Gilded diseases get the best care while the silver diseases are given lesser priority. (Ever notice that hospitals have hardwood floors in some areas, like the cancer units, while general medicine gets linoleum?) Mining gold generally means doing high-volume elective procedures and state-of-the art care—the stuff patients think will make them better in a short period of time. Mining silver involves primary and preventive care, like managing blood pressure. Because it's less lucrative to mine silver, even patients with comprehensive insurance are made to wait for doctors' appointments and often get bumped to E.R.s for regular care. In Redefining Health Care, economists Michael Porter and Elisabeth Teisberg detailed how this gold-mining scheme interferes with creating the best health outcomes because it devalues certain treatments and marginalizes patients with particular diseases. Improperly treated diabetes can be just as lethal as untreated cancer, but while hospitals roll out the red carpet for cancer patients, diabetics get the shaft.. . . .

Continue reading

January 28, 2009 | Permalink | Comments (0) | TrackBack (2)

Tuesday, January 27, 2009

Mercy Killing: No Further Jail Time

The LA Times provides an update on an attempted mercy killing and the final determination of whether to prosecute the individual who made the attempt.  Catherine Sailant reports,

James Wheeler, the 85-year-old Carpinteria man who attempted to kill his dementia-stricken wife and himself in September, won't be going back to jail after all.In a recent sentencing hearing, Ventura County Superior Court Judge George Eskin ruled that the seven days Wheeler spent in a Santa Barbara jail after his Sept. 17 arrest was enough. He'll also serve three years of probation and 100 hours of community service, Eskin decided at the sentencing Thursday. . . .

Wheeler's story galvanized people in Carpinteria and beyond. Many were incensed that the retired engineer could spend the rest of his life behind bars for what they saw as not a crime but an act of love. Wheeler told investigators that he had lost hope because his wife, in her fifth year of battling Alzheimer's, no longer recognized him. His plan to die with her by pumping car exhaust into their weathered beach cottage was interrupted by a neighbor who saw the exhaust hose and called police. . . .

"He realizes now there were probably other ways to deal with the situation,'' she said.

Sadly, his beloved wife, Betty, died Nov. 12. Wheeler eulogized his wife of 64 years in a memorial service in Carpinteria and wrote her obituary for the local paper,  which took up nearly a quarter of a page.

January 27, 2009 | Permalink | Comments (0) | TrackBack (1)

Kidney Transplant Recipients - Gender Gap

The New York Times reports on a new Johns Hopkins showing that older women are less likely to end up on the kidney transplant waiting list. Roni C. Rabin writes,


Women are less likely to receive kidney transplants than men, and researchers at Johns Hopkins have found that this gap primarily affects older women — even though they fare as well or better than men their age after a transplant.  . . .

They found that women 45 and younger were as likely as men to be placed on a transplant waiting list. But as women aged, their chances of getting on the list dropped, getting worse with each decade, said the lead author, Dr. Dorry Segev, a transplant surgeon at Johns Hopkins.

By the time women were 46 to 55, they were 3 percent less likely to be put on the transplant list. They were 15 percent less likely to be placed on the list at ages 56 to 65; 29 percent less likely at 66 to 75; and 59 percent less likely to be listed by the time they were 75 or older, Dr. Segev said.  The study was published in The Journal of the American Society of Nephrology.

Dr. Segev suggested that caregivers, family members and maybe the patients perceived older women to be more frail than they really are. “A lot of older women die without having an opportunity to get on the transplant list,” he said.

January 27, 2009 | Permalink | Comments (0) | TrackBack (3)

Monday, January 26, 2009

Vaccine Study Shows Safety

Newsweek reports on a recent Italian study that demonstrates the safety of vaccines.   Carla Johnson writes

A new study from Italy adds to a mountain of evidence that a mercury-based preservative once used in many vaccines doesn't hurt children, offering more reassurance to parents.

In the early 1990s, thousands of healthy Italian babies in a study of whooping cough vaccines got two different amounts of the preservative thimerosal (pronounced thih-MEHR'-uh-sawl) from all their routine shots.  Ten years later, 1,403 of those children took a battery of brain function tests. Researchers found small differences in only two of 24 measurements and those "might be attributable to chance," they wrote in the February issue of the journal Pediatrics, which was released Monday.

Only one case of autism was found, and that was in the group that got the lower level of thimerosal.  Autism is a complex disorder featuring repetitive behaviors and poor social interaction and communication skills. Scientists generally believe genetics plays a role in causing the disorder; a theory that thimerosal is to blame has been repeatedly discounted in scientific studies.

"Put together with the evidence of all the other studies, this tells us there is no reason to worry about the effect of thimerosal in vaccines," said the new study's lead author, Dr. Alberto Tozzi of Bambino Gesu Hospital in Rome. . . .

January 26, 2009 | Permalink | Comments (0) | TrackBack (3)

Pfizer-Wyeth Pharmaceutical Merger

The Wall Street Journal's Health Blog has many pieces today on the merger of Pfizer and Wyeth Pharmaceuticals.  Sarah Rubenstein of the Health Blog writes,

Pfizer has agreed to acquire Wyeth in a $68 billion deal that’s the largest merger in the pharmaceutical industry in nearly a decade. In announcing the deal, the companies made clear that Pfizer has in mind to cut its reliance on traditional pills.

“With its broad and diversified global product portfolio and reduced dependence on small molecules, the new company will be positioned for improved, consistent and stable top-line and [earnings] growth and sustainable shareholder value in the short and long term,” the companies say. “It is expected that no drug will account for more than 10 percent of the combined company’s revenue in 2012.”   That’s putting the best face on the loss of patent protection for cholesterol-fighter Lipitor in late 2011, we suppose. Last year Pfizer registered $12.7 billion in Lipitor sales, or a quarter of company revenue.

For further stories, see here and here.  Also, the Wall Street Journal's Health blog predicts future mergers in the pharmaceutical industry and states,

As Credit Suisse analyst Catherine Arnold put it in a note this morning, a Pfizer-Wyeth deal could “mark the beginning of a year of sector consolidation and could trigger other pharma-pharma or pharma-biotech deals.” Big deals often haven’t gone well for the industry, but the combination of lots of cash sloshing around and looming patent expirations may make deals impossible to resist.

She cites Bristol-Myers Squibb as a possible target. Then again, everybody always cites Bristol as a target — including Deusche Bank analyst Barbara Ryan, who in a note this morning mentioned both Bristol and Schering-Plough, whose stock has yet to recover from last year’s Vytorin imbroglio. . . . .

January 26, 2009 | Permalink | Comments (0) | TrackBack (0)

Sunday, January 25, 2009

Global Gag Rule Overturned

President Obama overturned the rule banning federal funds to international family planning groups that either offer abortions or provide information about them.  The Guardian U.K. reports,

President Barack Obama today made the most contentious move of his young administration with an order, overturning a ban on federal funds to foreign family planning organisations that either offer abortions or provide information or counselling about abortion.  The rule change continues the dismantling of George Bush's conservative policies. It is likely to encounter fierce criticism from the still robust anti-abortion movement.

It will allow US aid, usually through the US agency for international development, to flow to HIV/Aids clinics, birth-control providers and other organisations that advocate or provide counselling about abortion across the world. It is known as the "global gag rule" because it denies US taxpayer dollars to clinics that even mention abortion to women with unplanned pregnancies. . . .

Family planning groups in America and the UK cheered the rule change. Dr Gill Greer, director general of London-based International Planned Parenthood Federation, estimated the gag rule had cost the group more than $100m for family planning and sexual and reproductive health programmes during the eight years of the Bush administration, which she said amounted to 36 million unplanned pregnancies and 15 million induced abortions. . . .

While both Clinton and Bush used the Roe v Wade anniversary to change US policy on abortion, Obama declined yesterday. He instead issued a statement reaffirming his commitment "to protecting a woman's right to choose".  "On the 36th anniversary of Roe v Wade, we are reminded that this decision not only protects women's health and reproductive freedom, but stands for a broader principle: that government should not intrude on our most private family matters," he said.

The rule comes as no surprise. During the president campaign Hillary Clinton, who as secretary of state will oversee foreign aid, pledged to end the rule. . . .

January 25, 2009 | Permalink | Comments (0) | TrackBack (0)

Saturday, January 24, 2009

Newshour Health Updates

The on-line PBS Newshour provides interesting health updatesPaul Solman, their economics correspondent, has a new post concerning the future of Medicare and Medicaid.  Here is an excerpt:

Question/Comment: What is the future of Social Security and Medicare in the next 20-years and how do you see it being changed to accommodate future generations?

Paul Solman: Medicare is a much bigger problem than Social Security. I think Medicare will be extended to all Americans at some point.

Nobel laureate economist George Akerlof convinced me, some years ago, that universal health insurance is inevitable because with genome testing, either you know that you're likely to have a serious disease but your insurance company doesn't, so you load up on insurance OR your company demands the test results and refuses you if the odds are bad. Either way, it's the death knell for a private insurance system; everyone has to be in the same UNIVERSAL risk pool.

But when that happens, and probably even before, Medicare will almost surely be changed in basic ways to further limit the procedures and pills it pays for. That's because the main reason health care costs will continue to rise steeply, as best I can tell, is technology. See my very personal take on this argument.

January 24, 2009 | Permalink | Comments (0) | TrackBack (3)

Friday, January 23, 2009

Clean Air Lead to Longer Life

The Boston Globe reports on a recent study in the New England Journal of Medicine showing that cleaner air in a number of our large cities has resulted in an average increase in life expectancy of five months.  --- writes,

Cuts in air pollution increased life expectancy an average of five months in Boston and dozens of other American cities in recent decades, a study from Harvard and Brigham Young universities strongly suggests.  The researchers looked at the amount of small-particle pollutants in 51 US cities - including Boston, Worcester, Springfield, and Providence - during the 1980s and '90s and found that the predicted lifespan increased most significantly in cities where air quality increased most dramatically.

The study, which appears in today's New England Journal of Medicine, signals that efforts to curtail the small, toxic particles spewed by power plants, factories, cars, and trucks and inhaled by city-dwellers had significant health benefits over those two decades. Several clean-air advocates and public health specialists said the results show that even stronger standards for air pollutants are needed.

"We had known with reasonable confidence for a while now that air pollution is bad for people's health," said Majid Ezzati, a professor at the Harvard School of Public Health and one of the study's authors. "The question still lingering was: Does lowering pollution have health benefits? The answer is yes." . . .

Other factors that have improved the predicted lifespan in recent decades range from medical advances, education, and income growth to changes in lifestyle, including healthier eating habits and quitting smoking.

Life expectancy does not directly indicate how long people live. Rather, it predicts how long the average person in a population would live if the death rate at a given time persisted for the person's lifetime. . . .

If cleaner air improves predicted lifespan, life expectancy has probably further increased in many parts of the nation during the past decade. Since 2000, air monitoring data show that the national average concentration of fine particles has decreased 11 percent, said Cathy Milbourn, spokeswoman for the US Environmental Protection Agency. . . .

January 23, 2009 | Permalink | Comments (0) | TrackBack (1)

FDA Approves Stem Cell Research

The New York Times reports on the FDA's approval of a stem cell therapy in humans.  Andrew Pollack writes,

In a research milestone, the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells.  Federal drug regulators said that political considerations had no role in the decision. Nevertheless, the move coincided with the inauguration of President Obama, who has pledged to remove some of the financing restrictions placed on the field by President George W. Bush.  The clearance of the clinical trial — of a treatment for spinal cord injury — is to be announced Friday by Geron, the biotechnology company that first applied to the Food and Drug Administration to conduct the trial last March. The F.D.A. had first said no, asking for more data.

Thomas B. Okarma, Geron’s chief executive, said Thursday that he did not think that the Bush administration’s objections to embryonic stem cell research played a role in the F.D.A.’s delaying approval.  “We really have no evidence,” Dr. Okarma said, “that there was any political overhang.”   But others said they suspected it was more than a coincidence that approval was granted right after the new administration took office.  “I think this approval is directly tied to the change in administration,” said Robert N. Klein, the chairman of California’s $3 billion stem cell research program. He said he thought the Bush administration had pressured the F.D.A. to delay the trial. . . .

The F.D.A. approval comes a little more than 10 years after the first human embryonic stem cells were isolated at the University of Wisconsin, in work financed by Geron.  Because the cells can turn into any type of cell in the body, the theory is they may one day be able to provide tissues to replace worn-out organs or nonfunctioning cells to treat diabetes, heart attacks and other diseases. The field is known as regenerative medicine. . . .

Geron’s trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site 7 to 14 days after the injury occurs, because there is evidence the therapy will not work for much older injuries.  The study is a so-called Phase I trial, aimed mainly at testing the safety of the therapy. There would still be years of testing and many hurdles to overcome before the treatment would become routinely available to patients. . . .

Even as some researchers hailed the onset of clinical trials, others expressed trepidation that if the therapy proves unsafe — or even if it is safe but does not work — it could cause a backlash that would set the field back for years.  “It would be a disaster, a nightmare, if we ran into these kinds of problems in this very first trial,” said Dr. John A. Kessler, the chairman of neurology and director of the stem cell institute at Northwestern University.  Dr. Kessler, whose own daughter was paralyzed from the waist down in a skiing accident, said he thought Geron’s therapy was not the ideal candidate for the first trial. He said results showing the therapy worked in moderately injured animals might not apply to more seriously injured people. “We really want the best trial to be done for this first trial, and this might not be it,” he said. . . .

The main safety concern is that if raw embryonic cells are put into the body, they can form tumors. Even though most such tumors do not spread like other cancers, any unwanted growth in the spinal cord can further damage nerves. . . .

January 23, 2009 | Permalink | Comments (0) | TrackBack (1)

Thursday, January 22, 2009

Social Determinants of Health

Gail Wilensky, former administrator of  the Health Care Financing Administration, during the presidency of
George H.W. Bush, and David Satcher, former surgeon general and assistant secretary of health during the presidency of Bill Clinton, have a piece in Health Affairs discussing improving health care provided to children - with a focus on social issues.   Here is the abstract:

The Obama administration faces daunting challenges to reform health care. 
The authors, commissioners on the World Health Organization’s Commission on the Social
Determinants of Health, believe that strategies to improve health by affecting the social determinants  may gain bipartisan support. These determinants—including the effects of poverty,
education, the treatment of women, employment opportunities, and limited access to
medical care for some—are as important in promoting health, if not more so, than the direct
medical determinants of health. Focusing on these determinants makes more sense than
waiting until people become sick and seek care, and it often costs much less.

January 22, 2009 | Permalink | Comments (0) | TrackBack (0)

Rating Hospitals by Death Rates in California

The LATimes reports the results of a rating system for California hospitals.  Lisa Girion writes,

Some hospitals are better than others. But for many years all patients had to go on was reputation, doctors' advice, word of mouth and advertising. Today, California follows some other states, the federal government and a few private groups in offering a window on hospital quality.

The study by state officials of hospital death rates shows that for eight common conditions and procedures -- including stroke, hip fracture and brain surgery -- the rates vary widely. 

The study looked at mortality rates for 2007 and 2006. It found that, in 2007, 25 hospitals had death rates that were significantly better than the state average on at least one indicator, while 94 were significantly worse in at least one area.

In 2006, 33 hospitals had mortality rates that were significantly better on at least one indicator, while 98 hospitals rated significantly worse on at least one indicator.  Los Angeles County hospitals fared especially well in acute stroke care, based on mortality statistics in 2007. Of 97 hospitals in the county, 13 had significantly better than average mortality ratings for stroke, while only one was worse than average on the indicator. . . .

Officials plan to post the study today at www.oshpd.ca.gov and said they hoped it would help improve care.  "It is our hope that the timely release of these new indicators will encourage California's hospitals to examine their practices and improve their quality of care and help inform consumers and patients about their healthcare choices," said David Carlisle, director of the Office of Statewide Health Planning and Development.

But the study was immediately criticized. Torrance Memorial Medical Center, which received a worse than average mortality rating for gastrointestinal hemorrhage, said the information was badly flawed.  The hospital's own review of the 40 deaths in 883 gastrointestinal hemorrhage cases during the two-year study period "revealed a startling result: 15 of the 40 patients did not expire at Torrance Memorial," the hospital said in a statement. "In fact, many of the patients listed by OSHPD as deceased are still known to us to be alive."  The hospital said it discovered a programming error in the electronic data transfer from its medical record system to the state. A recalculation without the 15 cases inadvertently classified as deaths would result in a mortality rate well within the state average, the hospital said. . . .

Neil Romanoff, vice president for medical affairs at Cedars, said the study offered a limited view of hospital care because it failed to take into account deaths that occurred shortly after hospitalization.  "If a hospital . . . transfers their patients out alive earlier and they die at the next level of care, what does that tell you?" Romanoff said. "These are complicated questions that are not clearly answered by one measure of quality."

Joseph Parker, director of the statewide health office's Health Outcomes Center, said a study that took into account deaths after hospitalization would be less timely. "There's a trade-off here," he said. "We wanted to get information here that is more recent and actionable."

The state plans to update the study annually and to expand the categories. The federal Centers for Medicare and Medicaid and about 15 states publicly report various hospital quality indicators. Some report how well hospitals adhere to model practice standards, while others look at mortality and other outcomes.


January 22, 2009 | Permalink | Comments (0) | TrackBack (2)

Wednesday, January 21, 2009

Health Care in the Inauguration Speech

The Wall Street Journal's Health Blog helpfully provides the two references to health care in President Obama's inauguration speech

We, focused as ever, listened for any tidbits about health care and heard two. First, there was an acknowledgment of the expense of health care in a long list of woes the nation now faces.

That we are in the midst of crisis is now well understood. Our nation is at war, against a far-reaching network of violence and hatred. Our economy is badly weakened, a consequence of greed and irresponsibility on the part of some, but also our collective failure to make hard choices and prepare the nation for a new age. Homes have been lost; jobs shed; businesses shuttered. Our health care is too costly; our schools fail too many; and each day brings further evidence that the ways we use energy strengthen our adversaries and threaten our planet.

Later, in keeping with Obama’s seemingly ceaseless message of hope, health came up again as the president talked about how the U.S. can “lay a new foundation for growth.”

For everywhere we look, there is work to be done. The state of the economy calls for action, bold and swift, and we will act - not only to create new jobs, but to lay a new foundation for growth. We will build the roads and bridges, the electric grids and digital lines that feed our commerce and bind us together. We will restore science to its rightful place, and wield technology’s wonders to raise health care’s quality and lower its cost. We will harness the sun and the winds and the soil to fuel our cars and run our factories. And we will transform our schools and colleges and universities to meet the demands of a new age. All this we can do. And all this we will do. . . . .

January 21, 2009 | Permalink | Comments (0) | TrackBack (1)

Faith v. Medicine

The New York Times has a story today on the tension between faith and medicine that exists for some families.  Dirk Johnson reports,

Kara Neumann, 11, had grown so weak that she could not walk or speak. Her parents, who believe that God alone has the ability to heal the sick, prayed for her recovery but did not take her to a doctor.  After an aunt from California called the sheriff’s department here, frantically pleading that the sick child be rescued, an ambulance arrived at the Neumann’s rural home on the outskirts of Wausau and rushed Kara to the hospital. She was pronounced dead on arrival.

The county coroner ruled that she had died from diabetic ketoacidosis resulting from undiagnosed and untreated juvenile diabetes. The condition occurs when the body fails to produce insulin, which leads to severe dehydration and impairment of muscle, lung and heart function.  “Basically everything stops,” said Dr. Louis Philipson, who directs the diabetes center at the University of Chicago Medical Center, explaining what occurs in patients who do not know or “are in denial that they have diabetes.”

About a month after Kara’s death last March, the Marathon County state attorney, Jill Falstad, brought charges of reckless endangerment against her parents, Dale and Leilani Neumann. Despite the Neumanns’ claim that the charges violated their constitutional right to religious freedom, Judge Vincent Howard of Marathon County Circuit Court ordered Ms. Neumann to stand trial on May 14, and Mr. Neumann on June 23. If convicted, each faces up to 25 years in prison. 

“The free exercise clause of the First Amendment protects religious belief,” the judge wrote in his ruling, “but not necessarily conduct.”  Wisconsin law, he noted, exempts a parent or guardian who treats a child with only prayer from being criminally charged with neglecting child welfare laws, but only “as long as a condition is not life threatening.” Kara’s parents, Judge Howard wrote, “were very well aware of her deteriorating medical condition.”

About 300 children have died in the United States in the last 25 years after medical care was withheld on religious grounds, said Rita Swan, executive director of Children’s Health Care Is a Legal Duty, a group based in Iowa that advocates punishment for parents who do not seek medical help when their children need it. Criminal codes in 30 states, including Wisconsin, provide some form of protection for practitioners of faith healing in cases of child neglect and other matters, protection that Ms. Swan’s group opposes. . . . 

In the last year, two other sets of parents, both in Oregon, were criminally charged because they had not sought medical care for their children on the ground that to do so would have violated their belief in faith healing. One couple were charged with manslaughter in the death of their 15-month-old daughter, who died of pneumonia last March. The other couple were charged with criminally negligent homicide in the death of their 16-year-old son, who died from complications of a urinary tract infection that was severely painful and easily treatable.

“Many types of abuses of children are motivated by rigid belief systems,” including severe corporal punishment, said Ms. Swan, a former Christian Scientist whose 16-month-old son, Matthew, died after she postponed taking him to a hospital for treatment of what proved to be meningitis. “We learned the hard way.”

All states give social service authorities the right to go into homes and petition for the removal of children, Ms. Swan said, but cases involving medical care often go unnoticed until too late. Parents who believe in faith healing, she said, may feel threatened by religious authorities who oppose medical treatment. Recalling her own experience, she said, “we knew that once we went to the doctor, we’d be cut off from God.” . . . .

Thanks to Jim Hart for bringing this artice to my attention.

January 21, 2009 | Permalink | Comments (0) | TrackBack (0)

Tuesday, January 20, 2009

Change Has Come

Here is the newly updated whitehouse.gov website.  Looks good.

January 20, 2009 | Permalink | Comments (0) | TrackBack (0)