Commercial CME loses funding from second drug firm

My lede:

GlaxoSmithKline plc, the world’s No. 2 selling drugmaker, said in September it will stop taking continuing medical education grant applications from medical education and communication companies.

The world’s top-selling drugmaker, Pfizer Inc., in July 2008, became the first company to steer its money away from these for-profit CME companies, often called MECCs. Critics argue that commercial CME providers are more likely than nonprofit providers to let bias slip into their offerings.

“A MECC can’t say to a drug company grant, ‘I can take this or leave this,’ whereas a medical center can say that, because they derive income from so many other sources,” said Daniel J. Carlat, MD, a prominent critic of industry support for CME and assistant clinical professor of psychiatry at the Tufts University School of Medicine in Massachusetts. “The incentives to create obviously promotional CME are much greater with MECCs than with other organizations.”

The whole shebang.

H1N1 gets busted in rhyme

My lede:

Sporting a pair of stylish aviator sunglasses as a hip-hop beat swells on the soundtrack, John D. Clarke, MD, seems at home in the rap video for which he won a national contest to find the best flu-prevention public service announcement.

But the first giveaway that the lyrics to this rap will stray far from typical Jay-Z fare is a close-up of Dr. Clarke’s name in script over the pocket on his white coat. Then he dishes out the rhyme: “Hand sanitizer, I advise you get it — why? It makes germs die when you rub and let it dry.”

The minute-long music video also advises patients to seek medical care if they believe they are infected with influenza A(H1N1), stay home when sick, use tissues when sneezing, wash their hands for 20 seconds, and avoid touching the nose, eyes and mouth.

The whole shebang.

The video:

Resident duty hours: Does more sleep mean safer care?

My lede:

“Oh, I forgot all about that,” Monal Joshi, MD, responded to a question from a senior resident during morning report. The internal medicine intern, entering the 25th hour of a 30-hour shift at Rush University Medical Center in Chicago, had overlooked a patient’s test result.

The slip was quickly caught by a supervisor, and no harm was done. But was the resident’s momentary lapse due to fatigue?

Dr. Joshi had at least two hours of sleep the night before — pretty good for when she’s on call.

Some other members of the five-person Rush internal medicine residency team looked worse for wear as their shifts neared the end one day last spring. Third-year medical student Shikha Wadhwani rested her hand on her head, blinking slowly and yawning widely, as the others went through their reports.

But Yoojin Kim, MD, an intern who slept from 3:30 a.m. to 6 a.m., looked bright as a fluorescent light as she sped through her patient reports.

Sleep scientists say staying awake for more than 16 hours decreases the ability to concentrate, impairs memory and hinders the ability to do tasks such as tracking test results on a monitor.

Yet sleep deprivation does not affect everyone the same way. Such is the enigma of the debate on whether resident duty-hour limits have helped patients.

Six years have passed since the Accreditation Council for Graduate Medical Education cut resident workweeks to 80 hours. The council also restricted shifts to 24 hours of call plus six hours of patient transition and educational activities.

Some health leaders said cutting back the weekend-long shifts and 120-hour workweeks that were common before the 2003 rules would yield a safety benefit — fewer patient deaths and fewer complications. But it is hard to make a definitive, evidence-based argument that the work-hour limits have improved patient outcomes, experts said.

The whole shebang.

Doctors often register unconscious bias against blacks

My lede:

White physicians, like white lawyers and white people with doctoral degrees, are not immune from an implicit preference for white people over black people, according to a study in the August Journal of Health Care for the Poor and Underserved.

Psychological testing shows that doctors do not differ from the general population or from other highly educated people in unconscious racial bias, the study said. But critics doubt whether these test results are associated with unequal treatment of black patients. Other research, including a new study of patients with breast or colon cancer, has concluded that disparities are driven not by racial bias, but by differences in where patients get medical care.

The whole shebang.

Pfizer pays big for off-label promotions

My lede:

A $2.3 billion settlement with Pfizer Inc. over off-label drug promotion has industry observers wondering whether the record-breaking deal will deter drugmakers from talking up unapproved medication uses with doctors.

A Pfizer subsidiary, Pharmacia & Upjohn Co., agreed to plead guilty in early September to a felony violation of the Food, Drug and Cosmetic Act for misbranding its COX-2 inhibitor, Bextra, for off-label uses. The company agreed to pay $1.3 billion in criminal fines for systematically promoting off-label Bextra use to physicians through marketing materials, drug rep talking points and more.

The whole shebang.

Research subjects want to know about financial conflicts

My lede:

Research participants want to be told about clinical investigators’ financial conflicts, and sharing that information usually enhances trust, a new study says.

But researchers behind the five-year, $3 million Conflict of Interest Notification Study, or COINS, warn that disclosure should not be the only strategy used to protect human subjects from the potential harms posed by investigators’ financial relationships with research sponsors.

The whole shebang.

Outsourcing of clinical trials raises ethical concerns

This is a big feature story, so here is my longish lede:

Deciding whether to participate in a clinical trial is not easy, no matter where the study takes place. Patients are faced with a mountain of information about the potential risks and uncertain benefits of becoming research subjects.

Add to that heady brew the stark disparity among patients in rich countries and those in developing nations, and concerns mount quickly about the growing number of global clinical trials tapping the poor as research subjects.

Compare, for example, the United States and India.

The average American income is $47,000 a year — 16 times what the average Indian takes home, according to the CIA World Factbook. There is one doctor for every 384 Americans, while there are 1,667 patients for each Indian doctor, the World Health Organization says. The average American patient consumes nearly $7,000 in medical care each year; the average Indian’s annual health care tally is $39. Nearly every American adult can read, but 39% of Indians are illiterate.

What does it mean for research subjects around the world to give informed consent when the playing field is so uneven?

The whole shebang.

Doctors shaky on FDA label status

My lede:

A 2006 Archives of Internal Medicine study of 725 million prescriptions found that about one in five orders was written off-label — that is, for a condition that has not received the Food and Drug Administration’s approval as a safe and effective use of the drug. More than 70% of these off-label prescriptions were for indications in which the drug ordered had little or no scientific support.

The results of a new survey in the Aug. 21 Pharmacoepidemiology and Drug Safety add more cause for concern, experts said. Four in 10 doctors queried about 22 medications believed at least one of the drugs was FDA-approved for a given indication when it was not so labeled and lacked scientific evidence backing the prescribing decision.

The whole shebang.

Quality-of-care concerns add to doctors’ stress

My lede:

As many as a third of doctors are dissatisfied with their work, stressed and burned out by increasing workloads and declining pay. But physicians’ well-being also is affected by the quality of care their practices deliver, according to a new study.

The results of a statewide survey of nearly 1,900 Massachusetts doctors published in the August Medical Care showed that 31% felt stressed, 27% were dissatisfied with their work and 17% felt isolated from colleagues. Doctors who said their practices had quality problems were more likely to feel stressed.

The whole shebang.

75% of discharge summaries don’t mention pending test results

My lede:

Patients are especially vulnerable to harmful medical mix-ups when they leave the hospital. Doctors and hospitals have devoted much attention in recent years to improving the process of reconciling the medications patients were taking before they arrived with what they should take after discharge.

New research highlights another continuity-of-care challenge: following up on tests ordered in the hospital. Four in 10 patients are discharged with test results pending, and about 9% of those tests should lead to a change in the patient’s care.

But how can primary care doctors check up on these tests if they do not know about them?

The whole shebang.

“Death panels” rhetoric puts end-of-life care in reform spotlight

My lede:

A relatively obscure provision in the House’s massive health system reform legislation that would reimburse physicians for counseling Medicare patients about end-of-life care options came under intense fire from conservative opponents in August.

The political fallout prompted a group of six senators working on health system reform to drop the idea from ongoing negotiations. The House may follow suit when Congress reconvenes in early September, sources said.

But physicians said the controversy shows that despite decades of focus on helping patients choose what — if any — interventions they want as they die, end-of-life care remains a political and ethical tripwire.

The whole shebang.

Pulling the plug on veggie kids: When is it OK?

My lede:

For nearly two decades, the medical and legal consensus has been that it is permissable to withdraw life-sustaining artificial hydration and nutrition from adult patients in a persistent vegetative state. But should that standard apply to children, too?

Yes, it should, but only if their parents agree, according to a new position statement issued by the American Academy of Pediatrics’ Committee on Bioethics and published in the August Pediatrics.

The whole shebang.

Has kidney trafficking come to the U.S.?

My lede:

Federal authorities in July charged a Brooklyn, N.Y., man with conspiracy to violate the federal law banning buying or selling of human organs. If the allegations are true, it would be the first documented case of a black market for organs for transplant operating in the U.S., and experts said it could undermine public confidence in the country’s organ system.

A criminal complaint filed in the U.S. District Court of New Jersey alleges that Levy Izhak Rosenbaum asked an undercover FBI agent for $160,000 to line up an unrelated living kidney donor from Israel. The agent pretended to be a longtime secretary of a cooperating witness and in need of a kidney for an uncle waiting on a transplant list in the Philadelphia area.

“This kind of thing happens in Third World countries. There have been suggestions of it happening here, but I just never believed them,” said Joren C. Madsen, MD, DPhil, president of the American Society of Transplantation and director of the Massachusetts General Hospital Transplant Center.

The whole shebang.