Getting the bad news with the good news about a drug.

Today's Philadelphia Inquirer has a good piece about drug studies that are tubed by the drug companies that sponsor them. Here's the set-up:

A doctor is thinking of trying a new drug on a 67-year-old patient because a study shows it works well in men only slightly younger. But the doctor doesn't know about a clinical trial that found serious side effects in older patients. Those results were never published.

John Schneider, a doctor of internal medicine and a member of the American Medical Association's Council on Scientific Affairs, fears that that scenario happens all too often.

Because drug companies often do not reveal the contents of studies that make their drugs look bad, he said, many doctors are frustrated because they sometimes prescribe medications without knowing all the information about them and possible side effects.

Now, the AMA is considering asking the federal government to open up this secretive world. The group's House of Delegates will vote during a meeting that starts Saturday on a resolution urging the U.S. Department of Health and Human Services to create a registry of all clinical trials and their results.

The power of a front-page story in The Times.

When I put up the message below (less than 3 hours ago), Ricks' book on Dylan was ranked 109. Right now, it's ranked 28. The power of the press, indeed. I wonder what it was ranked yesterday at this time (before the Times piece hit the Web). . . .

Bob Dylan -- master poet.

Christopher Ricks, professor of humanities at Boston University and the newly minted Professor of Poetry at Oxford, has a thing for Bob Dylan, and has published a 500-page tome, "Dylan's Visions of Sin" (Ecco Press), in support of the claim that Dylan is a master poet, according to an article in today's N.Y. Times. The Amazon.com sales rank for this book, which will be officially released on June 15, is already 109. Sometimes it pays to be cool.

Organ trafficking.

There was an interesting piece in yesterday's The Christian Science Monitor on international organ sales. Between this article and the lengthy one in the N.Y. Times Magazine on May 23, this topic is getting a lot of attention these days. Is the U.S. policy against organ sales eventually doomed?

A prescription for healthcare.

Does Harvard's Michael E. Porter have the right idea for reforming the health care system? You can sample his ideas in this story from today's Boston Globe. It summarizes an 18-page piece ("Fixing Competition in U.S. Health Care (HBR Research Report)" by Porter and Elizabeth Olmstead Teisberg) in the June issue of The Harvard Business Review. Here's HBR's description of the piece:

The U.S. health care system is in bad shape. Medical services are restricted or rationed, many patients receive poor care, and high rates of preventable medical error persist. There are wide and inexplicable differences in costs and quality among providers and across geographic areas. In well-functioning, competitive markets, such outcomes would be inconceivable. In health care, these results are intolerable. Competition in health care needs to change, say the authors. It currently operates at the wrong level. Payers, health plans, providers, physicians, and others in the system wrangle over the wrong things, in the wrong locations, and at the wrong times. System participants divide value instead of creating it. (And in some instances, they destroy it.) They shift costs onto one another, restrict access to care, stifle innovation, and hoard information--all without truly benefiting patients. This form of zero-sum competition must be replaced by competition at the level of preventing, diagnosing, and treating individual conditions and diseases. Among the authors' well-researched recommendations for reform: Standardized information about individual diseases and treatments should be collected and disseminated widely so patients can make informed choices about their care. Payers, providers, and health plans should establish transparent billing and pricing mechanisms to reduce cost shifting, confusion, pricing discrimination, and other inefficiencies in the system. And health care providers should be experts in certain conditions and treatments rather than try to be all things to all people. U.S. employers can also play a big role in reform by changing how they manage their health benefits.

HHS OIG publishes draft revised hospital compliance guidance.

In today's Federal Register we have the latest addition to the growing body of "compliance guidance" from the Office of Inspector General, this time in the form of changes to the previously published hospital compliance guidance (63 Fed. Reg. 8987 (February 23, 1998)). All of the OIG compliance guidance documents are collected here.

According to the preamble,

When the final version of this document is published, it will supplement the OIG’s prior compliance program guidance for hospitals issued in 1998. This draft contains new compliance recommendations and an expanded discussion of risk areas. The draft takes into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance.

Among other things, the draft revises the OIG's list of compliance "risk areas":

This section addresses the following areas of significant concern for hospitals: (A) Submission of accurate claims and information; (B) the referral statutes; (C) payments to reduce or limit services; (D) the Emergency Medical Treatment and Labor Act (EMTALA); (E) substandard care; (F) relationships with Federal health care program beneficiaries; (G) HIPAA Privacy and Security Rules; and (H) billing Medicare or Medicaid substantially in excess of usual charges. In addition, a final section (I) addresses several areas of general interest that, while not necessarily matters of significant risk, have been of continuing interest to the hospital community.

Final section (I) discusses (1) discounts to uninsured patients, (2) preventive care services, and (3) professional courtesy.

Pfizer pleads guilty to marketing drug illegally.

While doctors can prescribe drugs for any use, the promotion of drugs for these so-called "off-label uses" is prohibited. The FDA's guidance in this area is relatively clear, although the agency has been somewhat constrained by a federal district court (Washington Legal Foundation v. Friedman (requires WestLaw subscription)). So it was a big deal when Pfizer admitted in a Boston case yesterday that it had engaged in just such illegal marketing, including paying doctors to put their names on ghostwritten articles about the anti-seizure drug Neurontin. The Boston Globe's article is here.

Pediatric deaths due to error - Report.

As reported in today's Daily Dose, Pediatrics has published an article (link is to abstract only) that estimates thousands of pediatric patients die each year due to medical error:

Thousands of children die unnecessarily in hospitals because of medical errors stemming from patient-safety lapses, and the extra cost of care for pediatric patients exposed to 20 types of safety problems exceeds $1 billion annually, according to a study in the June Pediatrics. The study confirmed that medical errors are a significant problem for children as well as adults, and it identified the very young and the very poor as more vulnerable than children in general. Researchers from the department of pediatrics at Johns Hopkins University, Baltimore, said the figures on patient deaths were conservative. The methods used to identify 4,483 unnecessary deaths from an analysis of 5.7 million records in 2000 "can detect only a small portion of the types of patient safety events that actually happen in hospitals," according to the article.

More than 51,000 cases of medical error were discovered, and four of the 20 types of treatment failure occurred at a rate exceeding 100 per 10,000 discharges. Those were failure to rescue a patient suffering from a threatening event, postoperative sepsis, and obstetric trauma with and without the use of instrumentation. The study also recorded the financial cost of each of the 20 types of treatment failure. For example, each case of sepsis resulted in an average of 26 extra hospital days and $118,000 in extra charges.

The abstract concludes: "Patient safety problems for hospitalized children occur frequently and with substantial impacts to our health care industry. Unmeasurable by this study are the additional "costs" and "burdens" of safety events that our patients are forced to handle. Additional work to describe and quantify better these outcomes in addition to ones measured here can help solidify the "business case" for patient safety efforts."

Washington Post analyzes Kerry's health plan.

In its Saturday issue, The Washington Post ran an article by Ceci Connolly on the Kerry health plan. In the "we've heard this before" category, the plan seeks to obtain health-care savings (and therefore reduced premiums, and therefore more coverage for the working uninsured) through electronic medical records and disease-management requirements. The plan would also position the federal government as payor of last resort for catastrophic claims, in much the same role as it plays as ultimate reinsurer after natural disasters and terrorist attacks. The federal government would pay employers 75% of the cost of "catastrophic claims," defined as a single employee's claims over $50,000 in any one year. As Connelly notes: "Such catastrophic claims account for less than half of 1 percent of all claims but generate 20 percent of the nation's health care costs, according to the latest federal data." The relief felt by employers, insurers, and employees (hopefully) would come at a cost: "In exchange for the benefit, Kerry would require employers to offer insurance to every worker and to provide health programs that detect and manage chronic illnesses such as high blood pressure early enough to prevent the diseases from worsening." And the federal tab? "Emory University health economist Kenneth E. Thorpe estimates the reinsurance program would save businesses and employees $288 billion in premiums over a decade but cost the government $257 billion because of administrative reductions." Most of that price would be covered by rolling back tax breaks delivered to the wealthy after the 2002 mid-term elections.

How Private Is My Medical Information?

The Privacy Rights Clearinghouse has a good report on medical records and privacy, with a special emphasis on information that is not covered by HIPAA.

50-state rundown on gay-marriage laws.

Stateline.org has published a very helpful summary (updated June 4) of pending legislation, including constitutional amendments, from around the various states. Stateline.org says it "is a non-partisan, non-profit online news publication that reports each weekday on state government. Funded by The Pew Charitable Trusts it was created in 1999 to strengthen and enrich U.S. political journalism by providing information about political activity in the 50 state capitols. In an era of declining news media presence in statehouses, Stateline.org helps fill the coverage gap." Good web site to know about . . .

Stem cell research ethics debated.

Yesterday's Cincinnati Enquirer ran an interesting debate over the ethics of stem-cell research, with Jeffrey Kahn arguing in favor and John Willke arguing against the practice.

Indigent care: Texas Attorney General Op. No. GA-0198.

Texas Attorney General Greg Abbott issued an AG Opinion on indigent health care yesterday. It seems the Amarillo Hospital District sold its hospital, Northwest Texas Hospital, to Universal Health Systems of Amarillo, Inc., in 1996. UHS acquired, along with the hospital, the county's indigent-care obligations pursuant to Chapter 61 of the Health and Safety Act. Since then, UHS has noticed that some patients appear to have voluntarily waived their right to obtain employer-sponsored health insurance, preferring instead to obtain hospital services as indigent patients rather than as insured patients. UHS wanted to know whether they could require these patients to sign up for health insurance benefits with their employers so that UHS could obtain reimbursement for services rendered. The AG's answer, in a word, was "no." Here's the rationale:

In this case, the [Indigent Health Care and Treatment] Act does not contemplate that a health care provider may require an applicant for indigent health care to obtain insurance through the applicant's employer in certain circumstances. Section 61.007(5) of the Health and Safety Code, requiring an applicant to provide information regarding the "existence of insurance coverage," is phrased in the present tense. Tex. Health & Safety Code Ann. § 61.007(5) (Vernon 2001). It is concerned with an applicant's coverage at the time of the application, not the availability of coverage or the potential for coverage in the future. The Department's [i.e., the Department of State Health Services'] rule requiring an applicant to list information about any medical insurance household members "receive," see 25 Tex. Admin. Code § 14.101(a)(3)(E) (2004), similarly focuses on whether the applicant is insured at the time he or she applies for indigent health care. No other provision in chapter 61 of the Health and Safety Code or in the Department's rules expressly or implicitly authorizes a hospital district to require an applicant to purchase health insurance as a prerequisite to receiving indigent health care.

Moreover, absent a provision in the special law creating it, a hospital district has no authority to require an applicant to obtain insurance before the applicant is eligible for indigent health care. "A hospital district has only such authority as is expressly conferred on it by statute or necessarily implied from the authority expressly conferred to effectuate the express powers." Tex. Att'y Gen. Op. No. JC-0068 (1999) at 1. Without express authority, a hospital district may not adopt a standard for determining an applicant's income and resources that is stricter than the Department's standard. See Tex. Health & Safety Code Ann. § 61.052(a)(2) (Vernon 2001); see also id. § 61.052(e) (stating that, if the Department changes its income and resources requirements so that the hospital district's standards become stricter than the Department's, the hospital district must change its standard to at least comply with the Department's requirements). Because neither the statute nor the Department's rules permit a requirement that an applicant purchase insurance, any such hospital district requirement would be more restrictive than the state requirements and, absent express authority, would be impermissible under the statute.

Schiavo case on fast track to Florida Supreme Court.

The 2nd District Court of Appeal has approved Michael Schiavo's request that Jeb Bush's appeal go directly to the Supreme Court, which allows the litigants to bypass the intermediate appellate stage in the dispute over the validity of "Terri's Law," according to an article in the Tallahassee Democrat. Thanks to Kathy Cerminara for the heads up on this.

Meanwhile, Terri's parents are again contesting her husband's right to make medical decisions for her -- an issue that has been litigated and re-litigated and always comes out the same way every time - in favor of the husband. The Second District Court of Appeal's opinion from last June neatly summarizes the issue. Apparently "finality" is a foreign concept in Florida's court system.

For more on the lower court's opinion and other recent developments in this case go here and here.

Additional thoughts on late-term abortions.

If the Administration and Congress were serious about having a law that would pass constitutional muster, Pub. L. No. 108-105 needs only two simple changes. First, make it clear that the prohibition does not apply to any procedure that is performed before the fetus is viable. Second, include an exception so that the prohibition doesn't apply when it is necessary to protect the health of the pregnant woman. Both provisions are easy to write. Both come directly out of the Stenberg opinion, in which the Supreme Court struck down Nebraska's partial-birth abortion law because it failed to include these two provisions. And both would probably have increased support for the bill in Congress.

The absence of these two simple features suggests a number of possibilities:

• Maybe Congress and the Administration were more interested in a confrontation with the federal courts over partial-birth abortion than they were in enacting any meaningful legislation.


• Or perhaps Congress and the Administration were more interested in creating a campaign issue for the summer and fall of 2004 than they were in banning a procedure that is so rarely used but has such potent political symbolism.


• Finally, it is possible that the Administration and both houses of Congress truly believe that if this loose thread can be successfully pulled away from the body politic, the entire fabric of Roe v. Wade will surely follow.

Health insurance coverage and the kindness of strangers.

Health Affairs' May/June issue has an interesting article that show that workforce characteristics are a bigger influence on health care coverage rates than state health policies. Here's the journal's press release and summary:

Working In Communities With Greater Number Of ‘Advantaged’ Workers
Increases Likelihood Of Employer-Sponsored Coverage
BETHESDA, MD — Although there is wide variation across the country in the rate of employer-sponsored insurance, almost all of the variation can be accounted for by variation in individual demographic characteristics, employment characteristics, and a community effect, according to a new paper published today by Health Affairs and the California HealthCare Foundation.

Author Richard Kronick, a professor with the University of California, San Diego, and two colleagues use Current Population Survey data to demonstrate that community characteristics exert a strong “contextual effect” on employer-sponsored coverage. . . .

According to Kronick, all individual and job characteristics being equal, workers are more likely to receive employer-sponsored coverage in communities with a large proportion of high-income adults and greater numbers of manufacturing and public administration jobs, rather than those whose economy is weighted toward low-income adults, minority workers, and small-business jobs.

Kronick and colleagues conclude that the demographic characteristics of a community have more bearing on rates of employer-sponsored insurance (ESI) than do state policies aimed at reducing the number of uninsured, such as small-group market reform or elimination of benefit mandates.

“In almost all states the actual rate of ESI is within one or two percentage points of the level that would be expected based on demographic and employment characteristics and the contextual effect,” Kronick says.

“Other than Hawaii, there is very little that states have done to move the rate of ESI either substantially above or below the rate that would be expected based on the demographic and employment characteristics of the people who live in the state. The only effective action that any state has taken to substantially increase the level of ESI among workers is to require employers to offer insurance,” as Hawaii has, Kronick says.

The authors find that a worker with a given set of characteristics (age, race/ethnicity, income, family structure, size of employer, industry, health status, home ownership, and union membership) is 3.5 percentage points more likely to have employer-sponsored insurance if they live in a metropolitan area with a high-wage, high-skill economy than if the workers lives in an average metropolitan area.

“There is a strong contextual effect on coverage rates,” Kronick says. “Although there are wide variations across states in the rate of (employer-sponsored insurance), almost all of the variation can be accounted for by the combination of individual characteristics and the contextual effect.”

The authors offer three potential explanations for the “contextual effect”:

In areas where there are the types of workers who expect to have ESI (well-educated, higher-income, native-born Anglos), employers will be more likely to offer coverage. As a result, the search costs for a marginal worker to find a job offering insurance will be lower than in areas where there are fewer employers offering insurance

Total compensation, including ESI and other benefits, is more likely to higher in areas with larger numbers of higher-skilled workers

Workers in high-coverage areas may prefer to search longer for jobs with ESI, while workers in low-coverage areas may find it more acceptable to go without coverage

In other words, poorer and less urban states, with a less skilled workforce and fewer high-end and skilled jobs, can't do much to raise the rate of ESI, short of attracting more skilled jobs, more high-end employers, etc. And that means simultaneously granting tax breaks and spending more on improving public services, paying attention to public education and public health, all of which requires a stronger tax base. How does a comparatively poor state dig itself out of this hole?

The skewed politics of assisted suicide.

Liberals touting states' rights. Conservatives pooh-poohing individual liberty and freedom. The are just some of the political side-effects of the debate over physician-assisted suicide in the wake of the 9th Circuit's opinion last week telling the Justice Department (and John Ashcroft personally) to take a hike and leave Oregonians and their Death With Dignity Act alone. Today's on-line Wall Street Journal surveys the political wreckage (requires subscription), and helpfully provides links to various commentators:

• Associated Press article;


• Newsday editorial;


• Seattle Post Intelligencer editorial;


• spokeswoman for American Catholic Bishops Conference;
and

• editorial in LifeNews.com.

NY Times' extensive coverage of life and death under Oregon's PAS law.

The New York Times has a series of articles today about the reality of living and dying under Oregon's physician-assisted suicide law. The lead article is here. There is also a multimedia presentation on the voices of the terminally ill, which links off the main story page, and a brief story (with photos) of a woman who invited her friends in to experience her death together.

More on partial-birth abortion ruling.

Here's the essence of Judge Hamilton's ruling this morning (see below).

1. The partial-birth abortion law is unconstitutional in three respects.
a. The statutory definition of the procedure could apply to previability D&E procedures as well as inductions. It could also apply to the interventions performed by physicians who treat a woman experiencing a spontaneous second-trimester miscarriage. Physicians may face criminal prosecution under the statute for procedures than cannot always be predicted when they begin to treat their patients. This could reduce the availability of such procedures and could have an adverse impact on the physicians who continue to do the procedures. All of this amounts to an "undue burden," as that phrase has been explained in Casey and Stenberg: the law "has the effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus." The Nebraska law at issue in Stenberg was struck down for the same reason.
b. The law is unconstitutionally vague in two material respects: "partial-birth abortion has little if any medical significance; "living fetus" adds to the vagueness of the law because it does not pertain to viability or to the framework of Roe and Casey; and neither the "overt act" nor the scienter requirements of the statute save the law from unconstitutional vagueness.
c. Notwithstanding the extensive findings of Congress to the contrary, the Court concluded that the intact D&E procedure (referred to in Stenberg as "D&X" or "dilation and extraction") is relatively safe, and it may be safer than any of the alternative procedures under some circumstances. Therefore banning the procedure could endanger women's health. The Nebraska law at issue in Stenberg was struck down for the same reason.

2. The extensive Congressional findings in support of Congress' conclusion that intact D&E is never necessary for the health of the mother were reviewed by the court under an intermediate review standard, neither de novo (as the plaintiffs argued) nor with the extreme deference sought by the government's lawyers. Applying a standard akin to a "hard look," the court concluded that these findings were "unreasonable and . . . not supported by substanttial evidence [that] was available to Congress at the time."

Federal court declares partial-birth abortion law unconstitutional.

At 9:00am this morning, Federal District Judge Phyllis Hamilton issued a 117-page order permanently enjoining the enforcement of the federal partial-birth abortion law. The order is here (PDF); the statute may be viewed here.

As reported this morning by the San Francisco Chronicle:

The ruling applies to the nation's 900 or so Planned Parenthood clinics and their doctors, who perform roughly half of all abortions in the United States.

U.S. District Judge Phyllis Hamilton's ruling came in one of three lawsuits challenging the legislation President Bush signed last year. . . .

Federal judges in New York and Nebraska also heard challenges to the law earlier this year but have yet to rule. . . .

Late last year, Hamilton, a Clinton appointee, and federal judges in New York and Lincoln, Neb., blocked the act from being enforced pending the outcome of the court challenges. They began hearing testimony March 29. . . .

The Nebraska and New York cases are expected to conclude within weeks. The outcomes, which may conflict with one another, will almost certainly be appealed to the Supreme Court.

The New York case was brought by the National Abortion Federation, which represents nearly half the nation's abortion providers. The Nebraska case was brought by a few abortion doctors.