FDA's oversight of human-subject research: slim to none

That's the bottom line of a report from the Inspector General of DHHS, according to an article in the New York Times. The IG's report (pdf), and a news release (pdf) about its conclusions, were released today. In his typically media-friendly way, Art Caplan colorfully summarized the report's conclusions this way: "In many ways, rats and mice get greater protection as research subjects in the United States than do humans."

Health Lawyers Weekly, September 14

Crowell & Moring partner Art Lerner and counsel Michael Paddock have an analysis of the FTC's recent Evanston Northwestern Healthcare Corp. decision in this week's Health Lawyers Weekly from the AHLA. The decision, in which the Commission held that Evanston's acquisition of Highland Park Hospital violated Section 7 of the Clayton Act but declined to order divestiture, was a rare if not unprecedented response for the FTC.

Other items of note from this week's issue:

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• CMS Denies New York’s Plan For Expanding SCHIP, Opposition To New Policy Mounts
• Aventis Pays Over $190 Million To Settle FCA Claims Alleging Fraudulent Drug Pricing And Marketing Practices

Current Topics include Antitrust, Business Transactions, Fraud and Abuse, Healthcare Access, Healthcare Spending, Hospitals and Health Systems, Insurance, Managed Care, Medical Malpractice, Medicare, Physicians, and Tax.

Vatican reaffirms stance on obligatory nature of ANH

"The administration of food and water even by artificial means is, in principle, an ordinary and proportionate means of preserving life. It is therefore obligatory to the extent to which, and for as long as, it is shown to accomplish its proper finality, which is the hydration and nourishment of the patient. In this way suffering and death by starvation and dehydration are prevented." And ANH is just as ordinary and proportionate, and therefore just as mandatory, when the patient is in a permanent vegetative state.

This is from the recently posted "Responses to Certain Questions of the United States Confernce of Catholic Bishops Concerning Artificial Nutrition and Hydration," issues by the Congregation for the Doctrine of the Faith and, as if it needed to be said, "The Supreme Pontiff Benedict XVI, at the Audience granted to the undersigned Cardinal Prefect of the Congregation for the Doctrine of the Faith, approved these Responses, adopted in the Ordinary Session of the Congregation, and ordered their publication." The English translation is here, and the official commentary is here.

The big questions now are what will be the effect of these statements on health care decisions by Catholics and on the policies of Catholic healthcare institutions.

Insuring the uninsured: the right thing to do, but what's in it for me?

Today's New York Times has an article on the new round of health-care reform proposals that are being advanced by various presidential candidates. On the dim prospects for any of the proposals to extend coverage to the uninsured and improve coverage for the underinsured, the article makes the following point:

In short, altruism has its limits, as does the public’s appetite for trade-offs in their own lives for the sake of the uninsured, said Bill McInturff, a Republican pollster who worked for the insurance industry in 1993 and 1994. “Never, in my years of work, have I found someone who said, ‘I will reduce the quality of the health care I get so that all Americans can get something,’ ” he said. “Every time the debate reaches that point, it collapses.”

This time, candidates are emphasizing the benefits for people who already have insurance — lower costs for coverage, new programs to improve the quality of health care. “Everyone has to feel, at the end of the day, that they will get something,” said one Clinton adviser.

By coincidence, the September/October issue of Health Affairs offers an answer:

Expanding coverage to the forty-seven million Americans who now lack health insurance could greatly improve care for people who already are protected. Economists Mark Pauly of Wharton and José Pagán of the University of Texas-Pan American found that insured adults who live in communities with high uninsurance rates are more likely to face problems with access to care and quality than those who live in communities where more people are covered.

The link to the abstract of the Pauly-Pagan article ("Spillovers And Vulnerability: The Case Of Community Uninsurance") is here.