Rogue Reporting

According to an article just published in the Journal of General Internal Medicine, results of drug studies published in medical journals may be misleading.

The UCLA-Harvard study says that the drug trials published in the most influential medical journals including the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, the Annals of Internal Medicine, the British Medical Journal and the Archives of Internal Medicine are frequently designed in a way that yields misleading or confusing results.

Investigators analyzed all the randomized drug trials published in the above journals between June 1, 2008, and Sept. 30, 2010, to determine the prevalence of outcome measures that make data interpretation difficult.  In addition, they reviewed each study’s abstract to determine the percentage that reported results using relative rather than absolute numbers, which can also be misleading.

They specifically looked at three outcome measures that have received increasing criticism from scientific experts: surrogate outcomes, composite outcomes and disease-specific mortality and found that :

• 37% of the studies analyzed used surrogate outcomes – intermediate markers, such as a heart medication’s ability to lower blood pressure, but which may not be a good indicator of the medication’s impact on more important clinical outcomes, like heart attacks

• 34% used composite outcomes which consist of multiple individual outcomes of unequal importance lumped together, such as hospitalizations and mortality, making it difficult to understand the effects on each outcome individually

• 27% used disease-specific mortality, which measures deaths from a specific cause rather than from any cause. This may be a misleading measure because, even if a given treatment reduces one type of death, it could increase the risk of dying from another cause, to an equal or greater extent

“Patients and doctors care less about whether a medication lowers blood pressure than they do about whether it prevents heart attacks and strokes or decreases the risk of premature death,” said the study’s lead author, Dr. Michael Hochman, a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program at the David Geffen School of Medicine at UCLA’s division of general internal medicine and health services research, and at the U.S. Department of Veterans Affairs’ Los Angeles Medical Center.

Dr. Danny McCormick, the study’s senior author and a physician at the Cambridge Health Alliance and Harvard Medical School, added: “Patients also want to know, in as much detail as possible, what the effects of a treatment are, and this can be difficult when multiple outcomes of unequal importance are lumped together.”

The authors also found that 45% of exclusively commercially funded trials used surrogate endpoints, whereas only 29% of trials receiving non-commercial funding did. Furthermore, while 39% of exclusively commercially funded trials used disease-specific mortality, only 16% of trials receiving non-commercial funding did.

The study also showed that 44% of abstracts reported results in relative rather than absolute numbers, which can be misleading.  “The way in which study results are presented is critical,” McCormick said. “It’s one thing to say a medication lowers your risk of heart attacks from two-in-a-million to one-in-a-million, and something completely different to say a medication lowers your risk of heart attacks by 50 percent. Both ways of presenting the data are technically correct, but the second way, using relative numbers, could be misleading.”

To remedy the problems identified by their analysis, Hochman and McCormick believe that studies should report results in absolute numbers, either instead of, or in addition to, relative numbers, and that committees overseeing research studies should closely scrutinize study outcomes to ensure that lower-quality outcomes, like surrogate makers, are only used in appropriate circumstances.

So who’s to blame?  The pharma companies for using outcomes that are most likely to indicate favorable results for their products, the study authors for writing them up that way or the journals for accepting the manuscripts?  Let us know what you think.

UCLA settles after Selling Secrets of the Stars

SRxA’s Word on Health brings you news of yet another big payout – only this time it’s not pharma that’s paying the price.  In a settlement reached with federal regulators last week, UCLA agreed to pay an $865,000 for potential violations of federal privacy laws after hospital employees were accused of snooping into the medical records of celebrity patients.

The investigation by the U.S. Department of Health and Human Services revealed that workers repeatedly accessed patients’ electronic health records between 2005 and 2008. In 2008, California Department of Public Health officials announced results of their own investigation into the privacy breaches and found that UCLA hospital workers inappropriately accessed records of 1,041 patients since 2003.

The hospital later disciplined 165 employees through firings, suspensions and warnings and at least two former UCLA employees have faced criminal charges for medical privacy violations.

Former administrative specialist Lawanda Jackson, 50, pleaded guilty to selling information to the National Enquirer from the files of Britney Spears, Farrah Fawcett and other high-profile celebrities. She died from complications of breast cancer before she could be sentenced.

Former medical school researcher Huping Zhou was sentenced to four months in federal prison and fined $2,000 for reading the confidential medical files of co-workers and celebrities such as Drew Barrymore, Arnold Schwarzenegger and Tom Hanks.  Zhou, a Chinese national, claimed he didn’t know it was a violation of U.S. law to peep into the files.

These headline-grabbing breaches led California legislators to pass a bill boosting the maximum fine for privacy breaches at health facilities from $25,000 to $250,000.

UCLA Hospital System which includes Ronald Reagan UCLA Medical Center, Santa Monica-UCLA Medical Center and Orthopedic Hospital, and the UCLA Medical Group, a network of primary and specialty care satellite offices, has agreed to report to a federal monitor on the implementation of its corrective plan over the next three years.

In a statement Thursday, UCLA said it has taken steps over the past three years to retrain staff and strengthen its computer systems.

Coming the same week that the British tabloid News of the World  was caught hacking into the phones of celebrities, government officials and murder victims, a scandal that has led to the demise of the popular Sunday newspaper and the public disgrace of media magnate Rupert Murdoch, UCLA should consider themselves lucky.

IBS – a pain in the mind?

Some health problems are pretty simple to understand. If you have a sore throat, your doctor will take a swab and run tests to see if you have a strep infection. An odd-looking lump can be biopsied to see if it is cancerous. Unfortunately, with irritable bowel syndrome (IBS) it’s just not that simple.

IBS is a tough disorder to understand. Estimates suggest it affects as many as 1:5 Americans.  However, studies have failed to show any structural problems in the gut that would account for the symptoms of pain, bloating, diarrhea and constipation, leading cynics to suggest it’s “all in the mind”.

Now researchers have found a possible connection between IBS and the brain. Using  MRI scans, scientists revealed changes in the brains of women with the disorder. They took MRI scans of 55 IBS patients and 48 healthy women for comparison. Women with IBS tended to have decreases in gray matter in parts of the brain that govern attention and areas that suppress pain.

A similar link between the brain and chronic pain has been identified in other disorders, such as lower back pain and migraine. The study on IBS suggests that, like these other conditions, the problem may be due to the brain’s inability to inhibit the pain response.

Emeran Mayer MD, co-author of the UCLA study said, “The findings remove the idea once and for all that IBS symptoms are not real and are ‘only psychological and will give us more insight into better understanding IBS.”

SRxA’s Word on Health would like to hear from you, whether you have an IBS drug to promote, or a IBS story to tell.