Prescription Drug Abuse
Panel of experts recommends restricting access to painkillers containing hydrocodone. As concerns grow about widespread abuse of Vicodin and other painkillers that contain the opioid hydrocodone, an advisory panel has made recommendations to the Food and Drug Administration (FDA) that would limit patient access to these prescription drugs. The panel, convened at the request of the Drug Enforcement Administration, and meeting at a time when the number of deaths from painkiller abuse exceeds the number of deaths from cocaine and heroin abuse combined, recommended measures that would make the drugs harder to prescribe: Only written prescriptions from an MD, rather than faxed or phoned-in prescriptions, could be filled by pharmacists, and refills without a new prescription would not be allowed.
The 29-member panel was far from unanimous in this position, however; the vote of 19 for and 10 against suggests the range of opinions on this sensitive issue. Some opponents of the recommendations express fear that legitimate users of painkillers—frail nursing home patients, for example—would find it more difficult to obtain them; others suggest that, even if the restrictions succeeded in driving down the numbers of deaths from opioids, deaths from other drugs, such as heroin, would increase proportionately. Nevertheless, the FDA is expected to follow the recommendations. And legislation to crack down on “pill mills”—phony pain management clinics—has been introduced in Congress, where legislation to restrict the sale of opioids failed last year.
Neurological Disease
A published study has found no evidence that diseases such as Alzheimer’s and Parkinson’s are infectious. A group of recipients of cadaver-derived human growth hormone (c-hGH) does not appear to be at increased risk for Alzheimer’s and Parkinson’s disease despite their likely exposure to neurodegenerative disease (ND)-associated proteins and elevated risk of infectious prion protein-related disease, according to a report published Online First by JAMA Neurology.
David J. Irwin, MD, the University of Pennsylvania Perelman School of Medicine, Philadelphia, and colleagues looked for evidence for human-to-human transmission of Alzheimer’s disease (AD), Parkinson’s disease (PD), and related neurodegenerative disease (ND)-associated proteins (NDAPs) in c-hGH recipients. The study included 34 routine autopsy patients and a group of c-hGH recipients in the National Hormone and Pituitary Program (NHPP). No cases of AD or PD were identified, according to the study results.
“We found no evidence to support concerns that NDAPs underlying AD and PD transmit disease in humans despite evidence of their cell-to-cell transmission in model systems of these disorders. Further monitoring is required to confirm these conclusions,” the study concludes.
Cancer
Scripps physicians call for change in cancer tissue handling. Genetic sequencing technology is altering the way cancer is diagnosed and treated, but traditional specimen handling methods threaten to slow that progress. That’s the provocative message delivered recently in a column appearing in the Journal of the American Medical Association (JAMA) by Scripps Clinic physicians Eric Topol, Kelly Bethel, and Laura Goetz.
“Deciding how best to obtain [tumor] samples and how best to process them for whole genome or exome sequencing is a pivotal yet unresolved issue with several layers of complexity,” the researchers write. “As the new clinical applicability of genomics emerges at a fairly rapid rate, the field of pathology will arrive at a tipping point for a fundamental change in how cancer specimens are handled.”
Currently, tumor tissue obtained through a biopsy is fixed in formalin, a mixture of formaldehyde and water, and embedded in paraffin for microscopic viewing. However, because the chemical mixture damages DNA, sequencing tissue processed in this way can be difficult, if not impossible.
A better alternative, the researchers argue, is to also routinely freeze a portion of the specimen, which retains the tissue’s genetic coding while preserving it for future analysis. In order to have enough tissue to freeze, larger or additional biopsy samples may be required, using minimally invasive needle biopsy procedures.
Infectious Disease
Climate change may make flu seasons worse. According to the Centers for Disease Control and Prevention (CDC), influenza continues to be widespread in 38 states. Since this season’s severe epidemic started earlier than expected, many people who wanted to get a vaccination may not have received one before the outbreak began.
Research done at Arizona State University in Tempe suggests that climate change may have played a role in the early start of the flu season this year—and could have the same effect in years to come. Using data going back to 1997, researchers found that warm winters are usually followed by severe and early flu outbreaks. Last winter was one of the warmest on record; the current flu season is one of the worst, with an unusually high number of cases, a much more serious strain of influenza virus (H3N2), and an early onset. Using CDC data, the researchers found a pattern: warm winters were usually followed by heavy flu seasons. The results were published in PLOS Currents: Influenza.
“During warm winters, flu is less transmittable,” lead author Sherry Towers says. “Fewer people catch it.” That applies to both primary flu varieties, and it leaves a higher percentage of the population without immunity the next season.
Industry News
Ortho Clinical Diagnostics, owned by Johnson & Johnson, may be sold. Nothing has happened yet, but in its quarterly earnings report for the last quarter of 2012, Johnson & Johnson revealed that it is considering selling its Ortho Clinical Diagnostics business. It is also possible that J & J may turn Ortho Clinical into a stand-alone business. Ortho Clinical, which currently ranks fifth in the clinical diagnostics market, may be considered a “slow grower” by J & J, whose businesses generally have the greatest or second-greatest share of their respective markets. The impact of this potential reorganization on Ortho Clinical, maker of equipment for diagnostics and blood transfusion screening, and on its clinical laboratory customers, is not immediately clear. Meanwhile, some analysts expect Johnson & Johnson to turn its attention to the burgeoning molecular diagnostics business.
