HealthLawProf Blog

District of Columbia HIV Study

The Washington Post reported this week on a depressing study on HIV in the District of Columbia.  THe Post report states,

The first statistics ever amassed on HIV in the District, released today in a sweeping report, reveal "a modern epidemic" remarkable for its size, complexity and reach into all parts of the city. 

The numbers most starkly illustrate HIV's impact on the African American community. More than 80 percent of the 3,269 HIV cases identified between 2001 and 2006 were among black men, women and adolescents. Among women who tested positive, a rising percentage of local cases, nine of 10 were African American.

The 120-page report, which includes the city's first AIDS update since 2000, shows how a condition once considered a gay disease has moved into the general population. HIV was spread through heterosexual contact in more than 37 percent of the District's cases detected in that time period, in contrast to the 25 percent of cases attributable to men having sex with men.

"It blows the stereotype out of the water," said Shannon Hader, who became head of the District's HIV/AIDS Administration in October. Increases by sex, age and ward over the past six years underscore her blunt conclusion that "HIV is everybody's disease here."

The new numbers are a statistical snapshot, not an estimate of the prevalence of infection in the District, which is nearly 60 percent black. Hader, an epidemiologist and public health physician who has worked on the disease in this country and internationally, said previous projections remain valid: One in 20 city residents is thought to have HIV and 1 in 50 residents to have AIDS, the advanced manifestation of the virus.

Almost 12,500 people in the District were known to have HIV or AIDS in 2006, according to the report. Figures suggest that the number of new HIV cases began declining in 2003, but the administration said the drop more likely reflects underreporting or delayed reporting. A quarter-century into the epidemic, the city's cumulative number of AIDS cases exceeds 17,400.

"HIV/AIDS in the District has become a modern epidemic with complexities and challenges that continue to threaten the lives and well-being of far too many residents," the report states.

District health officials have long been faulted for the lack of HIV information and lagging AIDS data. Not until forced by federal funding requirements did the health department start tracking HIV. . . .

The District's AIDS rate is the worst of any city in the country, nearly twice the rate in New York and more than four times the incidence in Detroit, and it has been climbing faster than that of many jurisdictions. . . .

Illegal Immigrants and Health Care Costs

The LA Times contains a story discussing a recent study on the use of health care by illegal immigrants.  It turns out - they aren't using that as much health care as people seemed to have thought.

Illegal immigrants from Mexico and other Latin American countries are 50% less likely than U.S.-born Latinos to use hospital emergency rooms in California, according to a study published Monday in the journal Archives of Internal Medicine.

The cost of providing healthcare and other government services to illegal immigrants looms large in the national debate over immigration. In Los Angeles County, much of the focus of that debate has been on hospital emergency rooms. Ten have closed in the last five years, citing losses from treating the uninsured, and those that remain open are notorious for backlogs.

By federal law, hospitals must treat every emergency, regardless of a person's insurance -- or immigration -- status. Illegal immigrants, who often work at jobs that don't offer health insurance, are commonly seen as driving both the closures and the crowding. 

But the study found that while illegal immigrants are indeed less likely to be insured, they are also less likely to visit a doctor, clinic or emergency room.  "The current policy discourse that undocumented immigrants are a burden on the public because they overuse public resources is not borne out with data, for either primary care or emergency department care," said Alexander N. Ortega, an associate professor at UCLA's School of Public Health and the study's lead author. "In fact, they seem to be underutilizing the system, given their health needs." 

Ira Mehlman, media director for the Federation for American Immigration Reform, a group that lobbies for tougher immigration controls, said that usage rates are just one measure of illegal immigrants' effect on healthcare. The other factor, he said, is the cost to taxpayers, which Ortega's study did not examine. . . .

Financing Health Care - Consumer Debt

Frank Pasquale at Concurring Opinions has another interesting piece on who opposes universal health care coverage.  He writes,

Businessweek has been covering the medical debt industry in depth, and this week's installment newly demonstrates how eager financial interests are to advance "the transformation of medical bills into consumer debt:"

The pool of self-pay patients is mammoth: Some are among the nation's 47 million uninsured; others are among the 16 million whose plans offer scant coverage or have deductibles as high as $10,000. . . . .General Electric's powerful financial arm markets its CareCredit card to dentists, plastic surgeons, and some hospitals, with loan volume expected to hit $5 billion this year, up 40% from 2006. . . . "Everybody is saying [medical finance] is the next horizon—whether it is lines of credit or credit cards," says June St. John, a senior vice-president at Wachovia. . . .

****

Below the fold: a hidden TILA issue?:

At Spectrum Health, a nonprofit group of seven hospitals in Grand Rapids, Mich., self-pay patients who can write a check within 30 days receive a 20% discount; those who pay within six months get 10% off. Patients who charge their debts to CarePayment get no discount. Referring to CarePayment, Kathleen Engel, an associate professor at Cleveland-Marshall College of Law, asserts: "This is a markup, not a markdown." Engel, a consumer law expert, says that because hospitals effectively charge more when patients use CarePayment, the hospitals should disclose the price difference as the equivalent of an interest rate under the federal Truth in Lending Act.

Joseph Fifer, Spectrum's vice-president of finance, said its disclosure is legally sufficient. Steven M. Wright, Aequitas' senior managing director for health markets, agreed. Wright said Aequitas complies with the law by disclosing its payment terms when it sends CarePayment charge cards to new customers.

I guess so long as it's all disclosed, they may as well open payday lending branches in ERs. But here's a last word from the chief financial officer of Methodist Le Bonheur Healthcare:

"If we heal somebody medically, but we break them financially, have we really done what is in the best interest of the patient?"

Charming Hospice Story in the NY Times

The New York Times reports on hospice providers losing money - the attention grabbing and rather depressing headline reads:  "In Hospice Care, Longer Lives Mean Money Lost."  The article states,

Hundreds of hospice providers across the country are facing the catastrophic financial consequence of what would otherwise seem a positive development: their patients are living longer than expected.

Over the last eight years, the refusal of patients to die according to actuarial schedules has led the federal government to demand that hospices exceeding reimbursement limits repay hundreds of millions of dollars to Medicare.

The charges are assessed retrospectively, so in most cases the money has long since been spent on salaries, medicine and supplies. After absorbing huge assessments for several years, often by borrowing at high rates, a number of hospice providers are bracing for a new round that they fear may shut their doors.

One is Hometown Hospice, which has been providing care here since 2003 to some of the most destitute residents of Wilcox County, the poorest place in Alabama.  The locally owned, for-profit agency, which serves about 60 patients, mostly in their homes, had to repay the government $900,000, or 27 percent of its revenues, from its first two years of operation, said Tanya O. Walker-Butts, a co-owner. Its profits were wiped out in the time it took to open the demand letters, Ms. Walker-Butts said. . . .

In the early days of the Medicare hospice benefit, which was designed for those with less than six months to live, nearly all patients were cancer victims, who tended to die relatively quickly and predictably once curative efforts were abandoned.  But in the last five years, hospice use has skyrocketed among patients with less predictable trajectories, like those with Alzheimer’s disease and dementia. Those patients now form a majority of hospice consumers, and their average stays are far longer — 86 days for Alzheimer’s patients, for instance, compared with 44 for those with lung cancer, according to the Medicare Payment Advisory Commission.. . . .

Studies have reached various conclusions about whether hospice care actually saves money, especially for long-term patients. But a new study by Duke University researchers concluded that it saved Medicare an average of $2,300 per beneficiary, calling hospice “a rare situation whereby something that improves quality of life also appears to reduce costs.”

Antidepressants and Lifespan

Wow - anti-depressants may lead to longer life spans - at least according to some recent research reported in the journal Nature.  According to Majikthise,

"An antidepressant drug lengthens tiny worms' lives and offers hope of humans living longer too, US scientists say.

In the study, detailed in journal Nature, nematode worms were exposed to 88,000 chemicals in turn and mianserin extended lifespan by almost a third.

The drug seems to mimic the effects on the body of the only known animal long-life regime - virtual starvation. [BBC]"

The researchers don't know why worms exposed to mianserin lived about 30% longer than their untreated counterparts. The researchers took an empirical approach, exposing worms to thousands of different small molecules and noting the effects on survical. Head researcher Linda Buck of the Howard Hughs Medical Institute shared some preliminary hypotheses with Science Daily:

Buck said it was a surprise to find that a drug used to treat depression in humans could extend lifespan in worms. The researchers in Buck's lab found that in addition to inhibiting certain serotonin receptors in the worm, it also blocked receptors for another neurotransmitter, octopamine.

A number of observations support the idea that serotonin and octopamine may complement one another in a physiological context, Buck explained, with serotonin signaling the presence of food and octopamine signaling its absence or a state of starvation. C. elegans, for instance, usually only lays eggs when food is on hand. But serotonin stimulates egg laying in the absence of food, while octopamine inhibits egg laying even when food is nearby. Another example of interplay between the two chemicals is that pharyngeal pumping, the mechanism by which worms ingest food, is jump-started by serotonin and thwarted by octopamine.

"In our studies, mianserin had a much greater inhibitory effect on the serotonin receptor than the octopamine receptor," she said. "One possibility is that there is a dynamic equilibrium between serotonin and octopamine signaling and the drug tips the balance in the direction of octopamine signaling, producing a perceived, though not real, state of starvation that activates aging mechanisms downstream of dietary restriction." [SD]

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Find out who your Daddy is - Brought to you by Rite Aid

The New York Times reports on the spread on genetic testing to your local drugstore.  It reports,

Genetic testing is now available at the drugstore. A company called Sorenson Genomics has started selling a paternity test kit through Rite Aid stores in California, Oregon and Washington. It appears to be the first time a DNA test is being sold through a major pharmacy chain.  The move into the pharmacy is another in the spread of genetic testing directly to consumers. Many genetic tests, for health and diet advice, ancestry and paternity, are already available directly to consumers through the Internet.  But Sorenson hopes the corner drugstore will appeal to different customers, including those who do not want to wait three or five days for a kit to arrive in the mail after ordering it over the Internet. . . .

The test, sold under the brand name Identigene, has a suggested list price of $29.99, though a reporter purchased one at a Rite Aid in Santa Monica, Calif., for $19.99. There is an additional laboratory fee of $119 to have the samples analyzed.

The spread of genetic testing directly to consumers has alarmed some doctors and genetic counselors, who said some tests were not valid or that consumers might not be able to understand the results without counseling.  Myriad Genetics recently caused some controversy by advertising its test for breast cancer risk directly to women in the Northeast. And the Government Accountability Office, among others, has criticized a plethora of tests now available for advising on health risks and recommending diet and lifestyle changes.  “Just because something’s available does not mean it’s safe or effective or worth your money,” said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University. She said most genetic tests available directly to consumers had not been reviewed by the Food and Drug Administration.

Still, drugstores already sell various non-DNA diagnostic tests, including those for pregnancy, drug use, cholesterol, blood sugar and H.I.V. When some of these were introduced there was also controversy about whether consumers could perform the tests or understand the results themselves.  The results of a paternity test, unlike some of the medical tests, are pretty easy to understand.

The box contains three sets of cotton swabs to collect cheek samples from the child, the alleged father and the mother. (The mother is optional but helps strengthen the results, the company says.) The swabs are put into separate packets and mailed to Sorenson’s laboratory in Salt Lake City. Results are provided by mail, fax or on a password-protected Web site within five days of the laboratory receiving the samples.

Sorenson said the test was for peace of mind and that the results would probably not stand up in court because questions could be raised about whose samples were submitted. The kit advises people wanting to test for legal purposes to call the company and set up a chain of custody for the samples, which would cost an additional $200.

At least one other genetic test is sold in a drugstore. Sciona sells a $269 service that provides dietary advice based on genetic analysis through Pharmaca Integrative Pharmacy, a chain of 19 stores mainly in California and Colorado.  Rosalynn Gill, chief science officer of Sciona, said that Pharmaca, unlike most pharmacies, had dietitians on staff to help explain the purpose of the test to customers.  “It’s far too early to expect people to walk into a store and buy a genetic test directly off the shelf without some guidance or counsel,” she said. Still, Sciona gets most of its sales from the Internet and from multilevel marketing.

Wellness Programs and Employer Liability

Some types of employer-based wellness programs make me a little nervous - perhaps the employer has a little too much control over the way that people spend their precious free time.  Law.com has a brief overview of some of the recent wellness program litigation.  Some of these programs seem a bit agressive - even the ones that provide bonuses to employees for meeting certain health goals.  The article reports,

Employers are increasingly mandating that employees have healthy lifestyles, or face repercussions.  Mandatory wellness programs are popping up everywhere, lawyers say, requiring everything from cholesterol screening to weight-loss plans and yoga classes.

Several employers are starting to reward employees with extra cash for meeting certain company health goals. Others are fining those who refuse to take part in programs such as health screenings or opt not to follow a health coach's plan to get in shape. Some are even firing, or refusing to hire, those who test positive for nicotine use.  These tactics have labor and employment attorneys predicting a barrage of discrimination and privacy lawsuits. . . .

Legal challenges to mandatory health checkups and screenings are already creeping their way into the courts.  In Massachusetts, a man is suing Scotts Miracle-Gro Co. for firing him after he tested positive for nicotine, violating a company policy banning smoking on and off the job. Rodrigues v. The Scotts Co., No. 1:07-cv-1014-GAO (D. Mass.).   Last year, a federal court in Michigan was the first to address mandatory wellness programs in a case in which firefighters challenged the city of Taylor Fire Department over a mandatory blood draw to detect cholesterol. The plaintiffs claimed that taking the blood violated their constitutional rights. The court denied the city's motion for summary judgment and the blood draws were abandoned. Anderson v. City of Taylor, 2006 U.S. Dist. Lexis 38075 (E.D. Mich.).   

But some companies are aggressively moving ahead with such plans, despite new federal Health Insurance Portability and Accountability Act rules that prohibit charging employees different rates for health coverage based on wellness, and ADA rules that prohibit employers from asking too many questions about an employee's health.

Maryville, Ohio-based Scotts Miracle-Gro, the national lawn care retailer, has a large-scale mandatory wellness program that includes an outright ban on all smoking. It also charges employees $40 a month more in premiums if they refuse to take part in a health-risk assessment, and $67 a month if they fail to comply with a health coach's plan to address various health problems. . . .

"The fact remains that many employers are cognizant of the epidemic that is the health care crisis," said Greg Keating, co-chairman of the health care practice group at Littler Mendelson. "Some large national employers are even willing to face legal challenges in an effort to reverse the rising tide of health care costs."  Littler Mendelson recently conducted a comprehensive study on employer-mandated wellness programs that looked at the potential legal pitfalls and benefits, and the effect of rising health care costs on employers. . . . .

But is that justification for mandating a healthy lifestyle for employees?

"The waters are murky here," said labor and employment attorney Neil Martin of the Houston office of Dallas-based Gardere Wynne Sewell. "Mandatory wellness programs — they sound good, but to me it's an issue of managing the unmanageable. They are fraught with all sorts of 'gotchas.' " According to Martin, the numerous legal risks associated with mandatory wellness programs include running afoul of the ADA, the Health Insurance Portability and Accountability Act and Title VII of the Civil Rights Act of 1964, which prohibits age, race and sex discrimination.   Additionally, 29 states have so-called "lifestyle discrimination statutes," which prohibit employers from taking adverse action against employees for lawful off-duty conduct. Those states include Colorado, Illinois, Nevada and New York. . . .

But employers will run into trouble if they penalize those with genetic traits or medical predispositions, he said.  "It's one thing to punish people or penalize them for lifestyle choices," Martin said. "It's a another if you're taking punitive action against them and they have a biological disposition or immutable characteristic . . . .Sometimes someone's health is beyond their control."

Massachusetts Health Plan

Erza Klein points out a potential problems with the Massachusetts health care plan - people are not signing up.  He isn't too worried about this fact and states,

So far as I can tell, with seven weeks left, 20 percent of the state's uninsured population hasn't signed up for insurance.   Given that people are lazy, and tend to wait till deadlines to do things, that's not exactly a shocker.  You should see how I handle bills.  Moreover, the question with the individual mandate plans is not whether people sign up in advance, but whether they sign up after the plans kick in.  Put differently, what an individual mandate does is levy a financial penalty on those who don't sign up for insurance.  They do that because we expect people to not sign up for insurance.  So the question is whether that penalty works -- whether it can be enforced, be politically sustained, and then function as a spur to push people into the coverage pool.  If that doesn't work, then the Massachusetts plan won't work either.  But we're not there yet, nor anywhere near it. 

Universal Health Care or Else?

Crooks and Liars has a video of Presidential candidate John Edwards discussing his plan to encourage Congress to pass comprehensive health care reform including some form of universal health care coverage.  He says that he would introduce legislation to strip them of their own health care should they fail to pass health care reforms. Mmmm - I am not sure how popular that would be.  Ezra Klein has some thoughts -here and here.

Rising Rates of STDs

The LA Times and other papers (including my local paper which noted that Ohio's beat the national average in several STD categories).  According to the LA Times,

The number of newly diagnosed cases of the three most common sexually transmitted diseases rose for the second year in a row in the U.S., driven in part by an increase in risky sexual behavior, the Centers for Disease Control and Prevention reported Tuesday.

"Increases in all three of these STDs. . . underscore the need for vigilance," said Dr. John M. Douglas Jr., director of the CDC's division of STD prevention, which produced the report.

New cases of chlamydia, the most commonly reported infectious disease in 2006, were diagnosed at nearly three times the rate of gonorrhea, the second most commonly reported infectious disease, Douglas said.

"We believe since it's underreported, it probably represents a much bigger iceberg," he said.

Douglas said he was also worried about syphilis because "it was really primed for being eliminated, and we've seen reversals in what ought to be a preventable problem."

Officials are still analyzing why the STD rates are going up, but they believe the rise is related to insufficient public health funds, increased testing and a resurgence of risky sexual behavior in some groups.

Gosh, I am shocked.  I thought all that money spent on abstinence-only education was supposed to take care of this type of behavior.

Potential 10.1% Reduction in Physician Fee Schedules

AMNews reports on the potential for large cuts in physician fee schedules under Medicare.  It reports,

The Centers for Medicare & Medicaid Services final 2008 Medicare physician fee schedule rule institutes an average 10.1% pay cut effective Jan. 1, 2008, although the percentage will vary by specialty, practice and geography.

The rule also lists the 74 quality measures to be used in the Physicians Quality Reporting Initiative in 2008. It specifies that a $1.35 billion fund adopted last year will go to the PQRI and not toward easing physician pay cuts. The regulation also delays finalizing most of the latest revised physician self-referral, or "Stark," rules.

Medical organizations called the 10.1% reduction unacceptable.

"Congress must step in to replace the cut with payment increases that keep up with medical practice costs," said American Medical Association Board of Trustees Chair Edward L. Langston, MD. "Next year's 10.1% physician payment cut is bad news for America's seniors as 60% of physicians say the cut will force them to limit the number of new Medicare patients they can treat." . . .

Lawmakers continue to work on legislation to prevent next year's cut.

In the House, an Energy and Commerce Committee staff member said leaders are sticking with the Medicare physician pay provisions adopted as part of its State Children's Health Insurance Program reauthorization bill in early August. The measure would have increased reimbursement 0.5% in 2008 and 2009 each.

Cuts to Medicare Advantage health plans' payment would have largely funded the boost. Specifically, these cuts would have lowered Medicare's regional benchmark payments to insurance companies, ended a stabilization fund used to share risks with insurance companies and eliminated indirect medical education payments to teaching hospitals.

These changes would reduce enrollment by more than half of the projected 12.5 million enrollees in 2012, according to an Oct. 10 Congressional Budget Office analysis. Today 8.2 million people are in these health plans.  But the provisions were removed in the House-Senate compromise SCHIP bill in an attempt to maintain a veto-proof Senate majority. Many Senate Republicans oppose cutting private health plan payments.

Still, Sen. Max Baucus (D, Mont.), chair of the Senate Finance Committee, would prefer to adopt a two-year payment fix by shifting some Medicare Advantage payments to fund physician reimbursement, said panel spokeswoman Carol Guthrie. But Republican members' support of such a measure was not clear at press time.

Economics of Universal Health Care

MrMichaelMT discusses the economics of universal health care at the DailyKos blog.  He points to many of the costs of the uninsured and says,

With the release of Sicko and the expected barrage of trash aimed at Democratic candidates from right wing radio, it's inevitable that someone will accost you. (After all, that "I'm a Progressive" tatoo on your forehead stands out.)  -   "Why should I pay for someone else's health care? I'm paying enough already!"

The major candidates have done an incredibly poor job of articulating what the savings would be to our society that universal healthcare would achieve. So I guess it's up to you.  Get ready to answer: "Yes, you are! You are paying way too much. Universal health care will save you, personally, a bundle."

When you are sitting in church or the movie theater, look to your right and your left, ahead and back. Chances are that one of those people is paying health roulette. When they get really, really sick they go to an emergency room--and you pay.

This issue update from the Kaiser Family Foundation finds that uninsured Americans could incur nearly $41 billion in uncompensated health care treatment in 2004, with federal, state and local governments paying as much as 85 percent of the care. It also finds that if the country provided coverage to all the uninsured, the cost of additional medical care provided to the newly insured would be $48 billion.

So if you just skim the headline, you might mistakenly think you are saving 7 billion by not covering the uninsured. Guess again! By waiting until health care is critical, the cost of healing the uninsured is many times the cost of insuring--and caring for--them in advance. Just remember the case of Deamonte Driver.

Deamonte Driver's life could have been spared if his infected tooth was simply removed -- a procedure costing just $80...
In the end, Driver endured two surgeries and weeks of hospital care totaling about $250,000 in medical bills. Sadly, it was too late to save the boy, and he passed away on Feb. 25. . . . .

Tom Delay on Health Care

ThinkProgress reports on former Congressman Tom Delay and his recent discussion on health care.  They state,

Speaking in the UK yesterday, former House Majority Leader Tom DeLay (R-TX) predicted that if a Democrat is elected president in 2008, he or she would seek to install universal health care, similar to the system in Britain. This possibility “received thunderous applause.” DeLay claimed that, under the U.S. system, “no American is denied health care”:

By the way, there’s no one denied health care in America. There are 47 million people who don’t have health insurance, but no American is denied health care in America.

The audience, understandably, greeted DeLay’s preposterous claims with “derisive laughter,” according to the AP. A recent report showed that for the sixth straight year, jobholders continued to see a decline in employer-provided health insurance, with 38 states seeing “significant” drops in benefits offered by employers.

I know that some Americans like to bash the UK's health system but there surely is no need to make a false statement like this.

Merck's Vioxx Settlement

Last week, Merck announced that it  The New York Times writes about the settlement as a corporate victory for Merck.  It reports,

For the drug maker Merck to pay almost $5 billion to settle lawsuits from people who contended that the painkiller Vioxx caused their heart attacks and strokes may not seem like a corporate victory.  But it is, according to lawyers and drug industry analysts who have followed the Vioxx litigation since Merck stopped selling the drug in September 2004, after a clinical trial showed it raised the risk of strokes and heart attacks.  At a fraction of the price that analysts initially estimated it would pay, Merck, one of the largest American drug makers, hopes to put one of the most troubling episodes in its history behind it.

The settlement amount it announced yesterday, $4.85 billion, represents only about nine months of profit for Merck, whose stock rose 2.3 percent on news of the agreement, even as the broader stock market was sharply lower. Two years ago, some analysts estimated that Merck would have to pay as much as $25 billion to settle Vioxx claims.

The success of Merck ’s strategy — fighting every claim against it in court for several years and only then agreeing to a blanket settlement — could encourage other pharmaceutical companies to take the same route in other lawsuits, independent legal experts say. Merck has won most of the cases to reach juries, as plaintiffs’ lawyers have struggled to convince jurors that Vioxx caused the heart problems their clients suffered.

Clinical trials prove that Vioxx raises the risk of heart attacks, but linking its use to any one person’s problems is difficult, especially when the person had other risk factors like smoking.  More broadly, the case shows that after years of aggressively lobbying against trial lawyers, corporate America has regained substantial leverage against plaintiffs and their lawyers — whose lawsuits bankrupted Dow Corning and the asbestos industry in the 1990s. In many states, changes governing lawsuits have made claims tougher to bring and win, while much public opinion has turned against plaintiffs.  “The law governing class-actions has grown decidedly less favorable than it was,” said Peter Schuck, a professor at Yale Law School who specializes in complex litigation. . . .

Of course, what is good news for Merck may be less so for the patients who suffered heart attacks or strokes after taking Vioxx. Depending on how many claims are filed to the settlement fund, those people will receive payments averaging about $120,000 each before legal fees and expenses, which could swallow about 40 percent of their payments.  Plaintiffs are not required to accept the settlement. But under terms of the agreement their lawyers must encourage them to do so — and would not be allowed to represent those clients if they insisted on bringing their cases to court. . . .

Dr. Eric Topol, a cardiologist who in 2001 was co-author of a paper in The Journal of the American Medical Association warning of the risks of Vioxx, said he believed that the payment amounted to little more than a slap on the wrist for Merck.  “I think they’ve gotten off quite easily, frankly, for the problems that they’ve engendered,” Dr. Topol said. 

The Wall Street Journal's Health Blog has more on the numbers here and here.  This Vioxx settlement should leave Merck more time to deal with the fallout from its AIDs vaccine. 

Oregon Supreme Court Considers Circumcision Case

Concurring Opinions brings us up-to-date on the latest twist in a case involving the circumcision of a 12-year-old boy.  Sarah Waldeck writes,

On November 6, the Oregon Supreme Court heard a dispute between parents over the circumcision of their 12-year-old son. The father, who has recently converted to Judaism and has full custody of the boy, wants him circumcised. The mother is trying to stop the procedure and argues that it is both sexual and physical abuse. The lower court dismissed her challenge but would not permit the circumcision to occur until all appeals were exhausted.

There’s been plenty of talk about this case over at Law Blog. Reading the comments provides a snapshot of the debate over whether the United States should continue its practice of male infant circumcision. Law Blog has comments about the procedure’s health benefits and associated risks; assertions about whether circumcised males experience less sexual pleasure than uncircumcised males; and questions about whether one can criticize male circumcision and avoid being labeled anti-semitic. . . .

An article in the NY Sun quotes Geoff Miller at NYU as stating that he would “be quite shocked or at least surprised” if the Oregon Supreme Court reverses the lower court. Miller has good reason for his opinion, as courts have been unsympathetic to non-custodial parents who seek to prevent the circumcision of infants, and to custodial parents who claim the procedure was done without their informed consent. Still, this case may turn out differently than the rest. The Pacific Northwest has the lowest circumcision rates of anywhere in the county. The boy is 12. The combination of these two factors may mean that judges in Oregon view this case through a different cultural lens.

The case raises interesting questions about child autonomy in addition to the the entire range of issues surrounding male circumcision.  An OPB News, an Oregon news outlet discussing the case states, "Circumcision opponents are asking the Oregon Supreme Court to look to a trial court case last year in Chicago.  A divorced mother wanted her son circumcised, but the father did not.  The judge in that case did not rule on the religious issues.  Instead, he blocked the circumcision until the boy turned 18 and could decide for himself."

More Toy Recalls - This Time for Date Rape Drug Not Lead

The New York Times reports today on the latest toy recall - and it is rather frightening -

The story started with a 2-year-old boy who was taken to a suburban Sydney hospital on Oct. 5 in a shallow coma and suffering from seizurelike spasms. It ended with the latest recall of a Chinese-made toy, as the Consumer Product Safety Commission ordered the recall of 4.2 million Aqua Dots in the United States on Wednesday evening.  Bindeez is also sold under brand names like Aqua Dots. 

 

     

Connecting the two events were four weeks of medical sleuthing by Dr. Kevin Carpenter, a biochemical geneticist in Sydney. Dr. Carpenter discovered that the boy in Sydney had eaten Bindeez beads, celebrated as Australia’s “Toy of the Year.”  Once ingested, the beads released a chemical related to GHB, the banned date rape drug. The beads are marketed in North America as Aqua Dots.

Dr. Carpenter’s story demonstrates how recalls come about, in a time when they are becoming depressingly routine.

Doctors at the Children’s Hospital at Westmead, outside Sydney, first believed that the 2-year-old boy, whose name has not been released, had an inherited metabolic disorder. But when Dr. Carpenter checked urine samples the next day for the chemical markers of the disorder, he found GHB, which can render victims unconscious and even cause death through respiratory failure.  “We suspected at that time the child had been surreptitiously given” the drug by a family member or friend of the family, he said by phone from Sydney on Wednesday.

A follow-up test two days later showed that the GHB had disappeared from the boy’s body, which confirmed that the chemical had been ingested and was not occurring because of a genetic disorder. It was then that Dr. Carpenter learned that the boy had vomited beads before and after going into a shallow coma.

Dr. Carpenter obtained more of the boy’s beads and tested them in a mass spectrometer, a device that helps identify chemical compounds. “I saw a large peak of a substance I didn’t recognize,” he said.  The “peak” was an obscure industrial chemical used to prevent water-soluble glues from becoming sticky before they are needed. But when ingested, the chemical quickly breaks down to become GHB. The United States tightly restricts the chemical’s sale and places GHB in the same category as heroin.

Ok, perhaps now would be the time to increase our product safety enforcement, oh, I forgot - Nancy Nord, the acting chairwoman of the Consumer Product Safety Commission does not want more money and other tools for enforcement.  Silly me, I forgot that having one full-time employee to check on toys is sufficient.  Ezra Klein has a video urging action.

Robo-Doc: Cure for Our Health Care System

Medpage Today has the solution for our current health care crisis - the Robo-doc:

Specialists at University of Louisville Health Care on Thursday began using a robot to remotely treat patients at Owensboro Medical Health System in western Kentucky, the Louisville Courier-Journal reports. 

Specialists in areas such as neurology, cardiology and maternal-fetal medicine can use InTouch Technologies' RP-7 robot to consult with patients, observe vital signs on monitors and check heart rates, blood pressure readings or sonograms. The specialists in Louisville control the system using laptops and joysticks and receive help from doctors or nurses in Owensboro.

The robot system is the first in the state and one of about 130 being used worldwide, the Courier-Journal reports. University of Louisville Health Care officials did not disclose how much they paid for the system, but InTouch officials said each control station costs $2,500 and robots can be leased for five years for $5,000 per month.

Officials said the robot system could help counter Kentucky's physician shortage, specifically in rural areas. While 43% of the state's population lives in rural areas, just 23% of physicians practice in rural areas, according to the Courier-Journal. In addition, most medical experts and specialists practice in urban areas like Louisville and Lexington.

I think this is a really cool idea. Just replace us with robots! If you look at the lease rates, it really is affordable - especially when they have "double dollar days" at the robot dealership. At this rate, the pay is actually even less than you pay a midlevel provider ($60,000 per year), plus you don't have to worry about benefits, vacations, sickness, or even CME.

The downside is that you have to have real physicians at the other end controlling the joy sticks. This reduces the overall efficiency of the process and really cuts into the cost savings of having an independent robot doctor. Dealing with cranky human doctors is just a nuisance that we should not have to deal with.

So here is my solution.  Train a bunch of Grade School kids on Trauma Center: Second Opinion for the Nintendo Wii. Then they can control the robots remotely. This is a great idea because kids are far better at this kind of thing than are adults. My kids can cream me at driving games, even though I am a better driver in real life than they are. They can transform into a wolf and get enough jewels to open a magic trunk better than I can, but in real life I am far better at doing this. They can get their Bulbasaur to successfully defeat someone with a high-level Toxicroak using a vine whip attack, when...well, they are actually better at that in real life than I am. I was never good at the vine whip.

The rest of the article and suggestions are also quite fun.  I wonder if this idea will catch on . . . .

Obesity Not So Deadly - Glad to Learn This While Cheap Halloween Candy Readily Available

The Washington Post reports today on a new study in JAMA showing that

Being overweight boosts the risk of dying from diabetes and kidney disease but not cancer or heart disease, and carrying some extra pounds actually appears to protect against a host of other causes of death, federal researchers reported yesterday.   The counterintuitive findings, based on a detailed analysis of decades of government data about more than 39,000 Americans, supports the conclusions of a study the same group did two years ago that suggested the dangers of being overweight may be less dire than experts thought. . . .

"The take-home message is that the relationship between fat and mortality is more complicated than we tend to think," said Katherine M. Flegal, a senior research scientist at the Centers for Disease Control and Prevention in Atlanta, who led the study. "It's not a cookie-cutter, one-size-fits-all situation, where excess weight just increases your mortality risk for any and all causes of death."  The study, published today in the Journal of the American Medical Association, was greeted with sharply mixed reactions. Some praised it for providing persuasive evidence that the dangers of fat have been overblown. . . .

But others dismissed the findings as fundamentally flawed, saying an overwhelming body of evidence has documented the risks of being either overweight or obese.  "It's just rubbish," said Walter Willett, professor of epidemiology and nutrition at the Harvard School of Public Health. "It's just ludicrous to say there is no increased risk of mortality from being overweight. . . . From a health standpoint, it's definitely undesirable to be overweight." . . . .

The most surprising finding was that being overweight but not obese was associated only with excess mortality from diabetes and kidney disease -- not from cancer or heart disease. Moreover, the researchers found an apparent protective effect against all other causes of death, such as tuberculosis, emphysema, pneumonia, Alzheimer's disease and injuries. An association between excess weight and nearly 16,000 deaths from diabetes and kidney disease was overshadowed by a reduction of as many as 133,000 deaths from all other deaths unrelated to cancer or heart disease. Even moderately obese people appeared less likely to die of those causes.

Although the study did not examine why being overweight might guard against dying from some diseases, Flegal said other research has suggested that extra heft might supply the body with vital reserves to draw upon to fight illness and aid recovery. . . . .

Now for the downside -

"I think it would be very unfortunate if these findings made us complacent about becoming overweight," said JoAnn E. Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston. "We know being overweight is linked to increased incidence of major chronic disease, including diabetes, hypertension and cardiovascular disease," she said, adding that it "impairs physical function and decreases quality of life." In fact, another paper published in the same journal found that obesity is increasing disabilities among the elderly, making them less able to do simple things such as walk a quarter-mile, climb 10 steps, bend over or lift 10 pounds.  Flegal stressed that the findings should not encourage people to be overweight or change any public health recommendations.   "This doesn't mean being overweight is good for you," Flegal said. "But it is associated with less mortality than expected."

Global Tobacco Regulations

Professor Lawrence O. Gostin has an interesting article in the most recent issue of JAMA discussing the global spread of tobacco products and how best to regulate their use to protect the poorest from the harms of smoking.  He argues:

With stricter regulation and an increasing anti-tobacco culture, smoking rates in North America and Western Europe have plummeted. Tobacco executives have aggressively sought new markets in developing countries. The industry has been astonishingly successful as smoking worldwide is expected to massively increase, along with industry profits. The forces of globalization—unparalleled communication, transportation, and commerce—propel this trend.^{18 . . . .}

The industry's success in exploiting poor people will have enduring, harsh health and economic consequences in low- and middle-income countries. However, civil society is fighting back through global regulatory strategies and new global initiatives by Michael Bloomberg and the Gates Foundation to prevent 100 million deaths from tobacco by 2020.² The imperatives of science, ethics, and human rights oblige society to reduce the burden of smoking, particularly among the disadvantaged. Tobacco marketing and commerce, with all their destructive force, do not deserve sociolegal protections, such as freedom of trade and speech.

Senate Passes HHS Budget

According to a recent story in AMNews, the Senate's passage of a $479 billion HHS appropriations bill, achieved the necessary majority to help override a potential presidential veto.  AMNews reports that the House and Senate expect to reach a compromise HHS bill later this month.  The Senate bill contains the following:

The Senate measure generally resembles the House version. Both would boost funding to the National Institutes of Health, prevent the president's proposed virtual elimination of the Title VII medical education loan program and increase federal community health center funding.

The president's 2008 budget proposal would reduce Title VII medical student loan assistance to $10 million from $184.7 million in 2007 and would freeze funding for community health centers at $1.99 billion. It proposes reducing the National Institutes of Health budget by $310 million (2%).

The Senate budget measure would head in the other direction. It would add $5 million (2.7%) to Title VII and $250 million (12.5%) for community health centers. It would boost NIH funding by $1 billion (3.5%).

The health center increase would allow facilities to see nearly 2 million more patients, according to Dan Hawkins, senior vice president for programs and policy at the National Assn. of Community Health Centers.

"This bill will continue the vital expansion of health centers into more medically underserved communities across the country," he said.

The NIH increase would pay for an additional 400 grants, compared with fiscal 2007 and 700 more than the president's budget.

Even the Senate bill's increase wouldn't keep pace with today's biomedical inflation rate of 3.7%. The NIH needs $1.9 billion (6.7%) annual increases from 2008 to 2010 to restore it to the spending ability it had in 2002 before a series of flat budgets, said Jon Retzlaff, director of legislative relations for the Federation of American Societies for Experimental Biology.

Reforming our Health Care System: The Need for Facts

Yesterday, N. Gregory Mankiw , a former adviser to George Bush, and current adviser to Mitt Romney, has an article in the New York Times business section discussing the future of health care in America and the need to examine the facts before considering reform efforts.  He then repeats and debunks what he believes are some false facts about America's health care system - a system that he believes works fine and will get better.  For example, he takes issue with the 47 million uninsured number that has been in the news for quite some time.  He states,

Some 47 million Americans do not have health insurance.

This number from the Census Bureau is often cited as evidence that the health system is failing for many American families. Yet by masking tremendous heterogeneity in personal circumstances, the figure exaggerates the magnitude of the problem.

To start with, the 47 million includes about 10 million residents who are not American citizens. Many are illegal immigrants. Even if we had national health insurance, they would probably not be covered.

The number also fails to take full account of Medicaid, the government’s health program for the poor. For instance, it counts millions of the poor who are eligible for Medicaid but have not yet applied. These individuals, who are healthier, on average, than those who are enrolled, could always apply if they ever needed significant medical care. They are uninsured in name only.

The 47 million also includes many who could buy insurance but haven’t. The Census Bureau reports that 18 million of the uninsured have annual household income of more than $50,000, which puts them in the top half of the income distribution. About a quarter of the uninsured have been offered employer-provided insurance but declined coverage. . . .

Concurring Opinions commentator Frank Pasquale disagrees with Mr. Mankiw and cites to a recent article by Professor Timothy Jost drawing some opposite conclusions about the stability and desirability of our current health care system.

But for now, I'm inclined to agree with the perspective of Tim Jost. He is a health law scholar who has thought seriously about comparative health systems, and does not share Mankiw's tendency to "look on the bright side:"

[A] series of studies over the past decade have shown that the quality of health care in the United States is seriously deficient, and, in particular, that medical errors are common and often have serious consequences. Indeed, the quality of the health care Americans receive is no better, and in some respects worse, than that provided in many other countries that spend far less on health care and yet provide it for all of their citizens.

DailyKos commentator Tonyahky also contains a sharp critique of the facts used by Mr. Mankiw.  Here is the response to the 47 million number:

Even if 10 million of the uninsured are illegal immigrants, what about the other 37 million? He doesn't tell you that 9 million of the uninsured are children. He also does not tell you that in general, the only adults who even qualify for Medicaid in most states are people receiving TANF and individuals who are eligible for SSI.

And what about those who declined coverage offered by their employers? I thought we could do a little bit of second grade math to illustrate why so many of these individuals opt out of employer sponsored health insurance I'm going to use a friend's earnings, living expenses, and her employer's insurance premiums to illustrate why many people opt not to receive health insurance: (see here for rest of discussion of cost of health insurance) . . .

In 1950, about 5 percent of United States national income was spent on health care, including both private and public health spending. Today the share is about 16 percent. Many pundits regard the increasing cost as evidence that the system is too expensive.

What is Torture?

Brian Leiter's blog has a review of hypothetical responses from the Bush Administration to the question of whether the rack constitutes torture.   Some examples:

Mukasey: I haven’t been read into the details of the Rack, and I
understand that these details are classified. I am firmly opposed to
torture, torture is illegal, but I do not know whether the Rack is
torture. To comment further would be to expose sincere and loyal
Inquisitors to the possibility of retro-active condemnation.

Bush: I am not going to give aid to our enemies by disclosing details of
our interrogation techniques. But if we do expose detainees to the Rack
it is not torture, because we do not torture.

Cheney: A little stretching never hurt anybody. I understand it’s
actually recommended before exercising. . . .

Gonzalez: I cannot recall what the Rack was. Nor do I have any
recollection about whether I ever discussed it with the President. The
testimony of some that they heard me mention the Rack in a meeting on
March 23rd -- a meeting which I do not remember --may have been a
confusion of Rack with Iraq.

Daniel Levin: I cannot say since I have never been exposed to the Rack.
I do have an appointment next Friday for a 50 minute session in Seville.

I find nothing funny about the current waterboarding debate but this shows how ridiculous the Administration's response to torture has become.

Daylight Savings Time and Your Internal Clock

Slate.com has an interesting piece on the impact of daylight savings time on your overall well-being: 

This week, Dr. Sydney Spiesel discusses the disruptive effect of daylight-saving time on the body's internal rhythms, . . .

Question: After midnight next Sunday, the clocks where you live will move backward by one hour to shift an hour of daylight from afternoon to morning over the next four winter months. You will share this experience of daylight-saving time with about one-quarter of the people on Earth. What happens to your body's internal clock when it is suddenly reset by society's clock?

Context: The body's daily cycle of activities—the circadian rhythm—determines when we are sleepy and alert, when we want to eat, and even when we produce less urine so our nighttime sleep will be less interrupted. Though there is a spectrum of preferences, from "larks" to "owls," the internal clocks that set our circadian rhythm are mainly regulated by the time the sun rises. (Here's how to figure out which kind of bird you are.) We are not consciously aware of this dependency, and our time of awakening is often affected by external forces, like the need to get to work on time. Chronobiologists, the scientists who study our internal clocks, correct for these effects by comparing awake and asleep times on work days and free days. They have found that the relationship between the arrival of dawn and the midsleep point—the time halfway between the moment you fall asleep and the moment you wake up—remains constant, even as the time of sunrise changes when the length of the day varies with the seasons.

Study: A new German study uses this predictable relationship to study what happens to our internal clocks when the external clocks jump an hour forward or backward. Drawing from a database of 55,000 Central European subjects who submitted daily sleep records, they showed that the normal correlation between dawn and the sleep cycle becomes disrupted during the transition to daylight-saving time.

Findings: In an effort to clarify whether this change was due to the changed clock or to some other phenomenon, the authors zeroed in on the sleep-wake and activity cycles of 50 people during the weeks around the spring and autumn leaps forward and back. They found that the spring institution of daylight-saving time was exactly the moment when the coming of dawn disconnected from the body's sleep-wake cycles. When standard time returned in the autumn, the body's circadian rhythm again linked itself to the time of sunrise.

Conclusion: Practically speaking, what does this mean? If, as some recent research has suggested, sleep and psychiatric illness may be closely tied, perhaps the sleep disruptions associated with time changes might affect the incidence of psychiatric disease during the transition periods. An early study suggested that this was, indeed, the case; more recent research on patients with depression casts doubt on the association. There is clear evidence of a spike in car accidents associated with the spring transition to DST and the fall transition back to standard time. I am tempted to think that disturbances in circadian rhythm are the cause.

Enjoy that extra hour of sleep!

Immigration and Uninsured Rates

Ezra Klein posts a nifty chart showing the rate of uninsured over the past few years.  The chart debunks the notion that the uninsured rate has increased due to immigration issues.  He writes:

You occasionally hear conservatives argue that the problems of the uninsured in this country are entirely due to immigration. No immigrants, no increases in the uninsured. I've shot this point up before, but EPI helpfully graphed the debate, showing what would have happened to the population of the uninsured had immigration been frozen in 2000.

As you can see, freeze immigration and the 2.1% increase in the uninsured population becomes a...1.9% increase in the uninsured population. Which equals out to 5.7 million more Americans uninsured.

Evaluations of the Candidate's Health Care Plans

Matthew Yglesias writing for the Altantic.com examines the National Journal's evaluation of the Presidential Candidate's health care plans. 

It's true, of course, that when the crazy kids downstairs at National Journal put together a bipartisan group to evaluate the presidential candidate's health care plans that the results showed the Democrats' plans to be good, whereas the Republicans' plans are bad. More telling, though, is actually the specific nature of where the different plans did well. This is especially true because in some respects the categories appear to have been gerrymandered to make the total scores less embarrassing for the GOP. . . .

He does a nice job discussing the various ways the health plans would impact quality of care, employers, access and more.  He concludes,

All of these proposals are vague in some key respects, and nothing that's proposed on the campaign trail is going to be enacted as is by congress. But these plans show something about the values and priorities of the different parties. Republicans, basically, are looking to make sure that the federal budget contains as much headroom as possible for tax cuts for high-income and high-wealth individuals while minimizing financial burdens on large employers. Democrats, by contrast, are looking to improve the quality and accessibility of American health care.

Commercial for Health Insurance

Ezra Klein finds a funny ad for health insurance - boy those marketing people sure know how to sell their product.  By the way, I just hope the man, whose injury is discussed in the commercial, did not have some sort of pre-existing injury that would lead to a denial of coverage . . . .   Click here.

Number of Uninsured Americans Increases

What a surprise and a not-so-nice news story to start November - Reuters reports:

The number of Americans lacking health insurance rose by nearly 8.6 million to 47 million from 2000 to 2006, with children and workers from every income level losing coverage, a new report said on Thursday.  The increase was "driven primarily by the continued erosion in employer-provided health insurance," said the report by the Washington, D.C.-based Economic Policy Institute.

In 2006, 2.3 million fewer Americans received health benefits from their employers than in 2000, the report said, noting the decline does not take the population increase into account. Nearly 60 percent of the nation's children are covered by the insurance provided by their parents' employers, but 3.4 million fewer children had benefits in 2006 compared with 2000.

"Public health insurance is no longer offsetting these losses," said the report by the nonpartisan think-tank.  For jobholders, this was the sixth straight year of declines in health insurance coverage. The rate fell to just below 71 percent from nearly 75 percent in 2000.  "No category of workers was insulated from loss of coverage," as even workers whose earnings placed them in the top quintile saw coverage rates fall, the report said.

More men lost employer-provided health benefits than women. For men, the rate fell by almost 5 percentage points in the six-year period to 69 percent. For women, the rate fell just under 3 percentage points to nearly 73 percent.