FDA task force calls for more disclosure of drug, device information

My lede:

A Food and Drug Administration task force in May unveiled a series of 21 proposals to share publicly more information about pending or rejected drug and device applications, as well as agency enforcement actions. The move, which has drawn objections from companies fearful that greater disclosure will spill trade secrets, is part of a larger transparency drive the FDA launched last year.

The whole shebang.

Heart devices can be turned off near end of life

My lede:

It is legal and ethical to honor patient requests to deactivate implanted cardiac devices, and physicians should take the initiative in talking with terminally ill patients and their families about turning off the devices, according to a new expert panel consensus statement released in May.

Implantable cardioverter-defibrillators, or ICDs, can impose a particularly heavy burden on terminally ill patients, continuing to send electrical shocks as the patient dies.

“His defibrillator kept going off,” one family member of a dying patient told the authors of a study in the Dec. 7, 2004, Annals of Internal Medicine. “It went off 12 times in one night.”

The whole shebang.

Medicare to test allowing more than palliative care in hospice

My lede:

New changes to Medicare and Medicaid payment could address the emotionally wrenching dilemma faced by physicians and terminally ill patients forced to choose between continuing curative treatments and taking advantage of hospice care programs’ in-home palliative, psychological and spiritual services.

The health reform law enacted in March directs state Children’s Health Insurance Programs and Medicaid plans to immediately cover “concurrent care” — a combination of curative efforts and hospice care — for children with terminal illnesses. The Congressional Budget Office estimates that the expanded coverage will cost $200 million over 10 years.

The law also calls on the Health and Human Services secretary to conduct a three-year, budget-neutral demonstration project of concurrent care for Medicare patients at 15 hospice-care sites.

The whole shebang.

Informed consent: Hospitals explore personalizing risks

My lede:

Informed consent has long been a bedrock principle of medical ethics, but the form intended to document a patient’s understanding of a proposed intervention is too often written at a college reading level and is ambiguous about risks.

Some doctors are out to change that, bringing a personalized medical approach to informed consent.

Nine medical centers around the country — including the Mayo Clinic in Rochester, Minn., and the Henry Ford Hospital in Detroit — are testing an informed-consent process for patients undergoing nonemergent cardiac catheterization and potential angioplasty. The Web-based program draws on a national cardiovascular database to predict individualized risks of death, bleeding or restenosis.

Proponents of the effort say informed consent should include even more data, telling patients about cost, alternative treatments, and doctors’ and hospitals’ quality performance.

The whole shebang.

Specialty societies set new policy on drug company influence

My lede:

Under scrutiny from politicians and physician critics, some medical specialty societies are pledging to disclose the industry funding they receive and say what that money pays for.

The promise comes as part of a code approved in April by the Council of Medical Specialty Societies, whose member organizations together represent more than 650,000 American physicians. The pressure on physician organizations to tell the public about industry support and limit the companies’ influence on their educational, research and advocacy activities has been building over the last year.

The whole shebang.

Doctors at religious hospitals face ethical conflicts over care

My lede:

One in five primary care physicians working in religiously affiliated health care organizations has experienced a conflict over faith-based patient care policies, according to a new study in the Journal of General Internal Medicine.

The findings, based on a nationwide survey of 446 family physicians and internists, appear to be the first to document how frequently doctors disagree with institutional policies in areas such as reproductive and end-of-life care, said Debra B. Stulberg, MD, the study’s lead author.

The whole shebang.

Infection checklist effort expands, but national rates unchanged

My lede:

Some hospitals have virtually eliminated deadly catheter-related bloodstream infections by implementing a checklist of simple preventive measures, yet an initiative to spread the success nationwide has run into some resistance.

A project funded by the Agency for Healthcare Research and Quality, On the CUSP: Stop BSI, has attracted the participation of at least 400 hospitals in 27 states. The project seeks to build on the success in Michigan, where intensive care units at more than 100 hospitals cut their median central-line infection rate to zero per 1,000 catheter days, compared with a national average of 5.2.

The whole shebang.

“Grey’s Anatomy,” “House” dramas inspire ethics lessons

My lede:

It was bad enough that Seattle Grace Hospital intern Isobel “Izzie” Stevens, MD, fell in love with a patient in need of a heart transplant. But she really crossed the ethical line when she cut the wires to his left ventricular assist device so his health would deteriorate and he’d move higher on the United Network for Organ Sharing waiting list.

That behavior — portrayed by actress Katherine Heigl on the hit ABC TV medical drama “Grey’s Anatomy” — is probably the most outrageous example of scores of unethical medical actions shown on “Grey’s” and Fox TV’s “House,” according to a study in the April Journal of Medical Ethics.

The whole shebang.

JAMA urges journals to toughen data review

My lede:

Medical journal editors should require independent analysis of industry-sponsored trial data by an academic statistician before publishing results, according to an editorial published in the March 24/31 Journal of the American Medical Association.

The call comes in response to internal GlaxoSmithKline documents revealed as part of a February Senate Finance Committee report investigating the company’s handling of data related to its diabetes drug Avandia (rosiglitazone).

The whole shebang.

Safety on the syllabus

My lede:

Robert O. Bonow, MD, graduated from medical school in 1973. Caitlin Schaninger will graduate in June. Despite training in different generations, they see similar gaps in quality and safety education.

Much has changed in medical education in the nearly four decades that separate their medical school experiences.

What has remained largely unchanged is the lack of education most medical school graduates receive in the science and skills of quality improvement and patient safety — how to deliver the right care to the right patient at the right time, and how to prevent a patient from being harmed.

The whole shebang.