Cancer Care Group Data Breach Exposes Nearly 55,000 Patients

By Kyle Murphy
EHR Intelligence
Originally published August 28, 2012

In a press release today, Cancer Care Group (Indianapolis, IN) announced that a laptop computer containing its computer server backup media was stolen from an employee’s locked care on July 19, 2012. The breach has potentially exposed the protected health information (PHI) or personally identifiable information (PII) of close to 55,000 individuals, including the organization’s own employees. The latest incident comes less than a month after Apria Healthcare reported a similar incident in Arizona where an employee’s car was broken into and a laptop containing information for 11,000 patients stolen.

The entire story is here.

James Holmes' psychiatrist went to cops with concerns about a patient

By John Ingold and Jeremy P. Meyer
denverpost.com
Originally published August 30, 2012

Here are some excerpts:

On the day she last saw James Holmes, University of Colorado psychiatrist Lynne Fenton went to a campus police officer with concerns about a patient.

Fenton testified Thursday during a hearing in Holmes' murder case that she had no contact with Holmes after June 11. That same day, Fenton said, she contacted Officer Lynn Whitten about a patient. Fenton did not identify the patient, citing the confidentiality issues that were the focus of Thursday's hearing.

"I was trying to gather information for myself," Fenton said.

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The purpose of the hearing was for prosecutors and defense attorneys to debate whether a notebook Holmes mailed to Fenton the day before the July 20 rampage, which also left 58 injured, is a confidential communication between a doctor and a patient. The defense says it is. Prosecutors believe they should be able to look at it.

The hearing ended Thursday unfinished, and the issue will be taken up again Sept. 20.

The entire story is here.

Thanks to Gary Schoener for this story.

Johnson & Johnson Unit Settles State Cases Over Risperdal

By Katie Thomas
The New York Times - Business Day
Originally published August 30, 2012

Johnson & Johnson announced Thursday that its pharmaceutical unit had reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over its marketing of Risperdal, an antipsychotic drug.

The company’s pharmaceuticals subsidiary, Janssen, has been under scrutiny for years over its promotion of Risperdal, which treats symptoms of bipolar mania and schizophrenia. State and federal authorities have said that Janssen promoted the drug for uses it did not have approval for, including dementia in elderly patients, bipolar disorder in children and adolescents, depression and anxiety. Prosecutors have also accused the company of minimizing or concealing the risks associated with the drug.

In resolving the allegations by the states, Janssen did not admit wrongdoing or that it violated the law and said it settled to avoid “unnecessary expense and a prolonged legal process.”

The entire article is here.

Overtreatment as Myth

New York Times Letter to the Editor
Originally published September 3, 2012

To the Editor:

Re “Overtreatment Is Taking a Harmful Toll” (Well, Aug. 28): Undertreatment could be a much bigger problem than overtreatment. Studies by the RAND Institute, published in The New England Journal of Medicine, have found significant underuse of preventive testing and treatment for cervical, breast and colorectal cancer, as well as for H.I.V., heart disease and diabetes. RAND concluded that, on average, Americans receive only 55 percent of recommended preventive care and that underuse of such care was a bigger problem than overuse.

Alan Mertz

Washington

The writer is president, American Clinical Laboratory Association.

♦

To the Editor:

The overwhelming medical care in this country is actually appropriate. By emphasizing the bad experiences of a few, this article may end up suggesting to people that they should not trust their doctors.

Defensive medicine is sometimes practiced for fear of malpractice suits, but this should not be confused with the honest effort of the overwhelming majority of physicians to give their patients the best care possible.

Barry E. Rosenbloom, M.D.

Beverly Hills, Calif.

Health Care Flaws

To the Editor:

Originally published August 27, 2012

Re “A Reluctant Crash Course in Health Insurance 101” (The Agenda, Aug. 21): Suleika Jaouad’s dispassionate account of the added burdens imposed by our fragmented system of health insurance on those unfortunate individuals who become sick is powerful in its lack of sentimentality. With an unconscionable 45,000 excess deaths a year due to lack of health insurance, we remain the only country in the world where getting seriously ill or hurt, as if that weren’t bad enough, significantly increases one’s risk for financial ruin — even with health insurance. More than half of personal bankruptcies in the United States result from medical bills, and of those, 75 percent of the cases are people who had medical insurance when they got sick or injured.

Until the for-profit health insurance industry is replaced by a single-payer national health insurance program, Americans will continue to suffer and die for the sake of excessive corporate salaries and shareholder profits.

Elaine Fox, M.D.

Southampton, N.Y.

Do Post-Market Drug Trials Need a Higher Dose of Ethics?

Patients who sign up for trials testing more than one already approved intervention do not always know if one is being tested for harmful side effects

By Katherine Harmon
Scientific American
Originally published August 23, 2012

Here is an excerpt:

What you might not know—even after you sign up for the trial and have inked the informed-consent form—is that scattered reports are starting to suggest that the new medication might occasionally cause severe side effects. And the real reason the trial is being conducted with these previously released drugs is to test whether the new medication really is a lot riskier to everyone or just to a subset of patients.

If you found that out, would you still sign up for the trial? The problem is that many patients—and often even the institutional review boards that approve the trials—are never informed of these lingering questions.

This is one of the big ethical holes often left open in post-market trials, says Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, who co-authored a new essay on this topic in The New England Journal of Medicine, which was published online August 22. She and a team of co-authors released a formal Institute of Medicine (IOM) report earlier this year recommending that the FDA improve this and other ethical aspects of post-market trials—especially those it requires.

Click here for the entire story.

Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety

National Academies of Sciences
Released May 1, 2012

Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication's effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time.  Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication's benefit-risk profile throughout its entire "life cycle" from approval until it is no longer marketed, says a new report by the Institute of Medicine. 

According to recent estimates, nearly half of all Americans take at least one prescription drug daily and many older people use five or more, noted the committee that wrote the report.  The report's recommendations build on the new authorities and tools provided to the U.S. Food and Drug Administration through the Food and Drug Administration Amendments Act of 2007, which increased the agency's capacity to monitor drugs after approval and act if signs of safety problems appear. 

One of the committee's key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug.  This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market.  The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product's use, as well as benefit and risk assessments specific to these questions.  It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions.  Much of this information is already being gathered by FDA, but it is currently scattered across multiple records.  Putting the information into an accessible format in a single document would make FDA's commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data.

The entire news release is here.

The Cultural Salience of Moral Character and Virtue Declined in Twentieth Century America

By Pelin Kesebir and Selin Kesebir
Journal of Positive Psychology - Future Edition

Abstract:     

In a large corpus of American books, we tracked how frequently words related to moral excellence and virtue appeared over the 20th century. Considering the well-established cultural trend in the United States toward greater individualism and its implications for the moral domain, we predicted that morality and virtue terms would appear with diminishing frequency in American books. Two studies supported our predictions: Study 1 showed a decline in the use of general moral terms such as virtue, decency, and conscience throughout the 20th century. In Study 2, we examined the appearance frequency of 50 virtue words (e.g., honesty, patience, compassion) and found a significant decline for 74% of them. Overall, our findings suggest that during the 20th century, moral ideals and virtues have largely waned from the public conversation.

The entire paper is here.

Thanks to Ken Pope for this lead.

Harvard accuses 125 students of cheating

By Mary Carmichael
Boston.com
Originally published August 31, 2012

Harvard University is investigating 125 students accused of collaborating on a spring take-home final exam, in what could prove to be the largest Ivy League cheating scandal in recent memory.

Nearly half the students in an introductory government class are suspected of jointly coming up with answers or copying off one another. Groups of students appear to have worked together on responses to short questions and an essay assignment, violating a no-collaboration policy that was printed on the exam itself, said Jay Harris, Harvard’s dean of undergraduate education.

Although no students appear to have lifted text from outside sources, some apparently plagiarized their classmates’ work, submitting answers that were either identical or “too close for comfort,” Harris said Thursday.

A teaching fellow noticed the similarities in May while grading a subset of the exams. He alerted the professor, who approached the college’s Administrative Board, the body that oversees student behavior. The board was worried enough to spend the summer interviewing some of the students and reviewing every exam in the class.

The students whose tests were flagged as problematic — nearly 2 percent of the college’s approximately 6,700 undergraduates — have been notified and will appear before the board individually in the next few weeks, Harris said. Some may be exonerated, but those found guilty could face a range of punishments up to yearlong suspensions.

The entire story is here.