With a Free Meal from Pharma, Doctors Are More Likely to Prescribe Brand-Name Drugs, Study Shows

When doctors accept meals from pharmaceutical salespeople, they are much more likely to prescribe the drugs the representatives are promoting than cheaper generic alternatives, UC San Francisco researchers found in a study published online June 20, 2016, in JAMA Internal Medicine.

Researchers said this marketing strategy may be leading to higher out-of-pocket costs for patients, since brand-name drugs are not always covered by insurance to the extent that generic drugs are. Previous studies have linked generic drugs to better adherence, since many patients, particularly seniors, cannot afford brand-name drugs.

In the current study, the researchers found that physicians who received just one meal, costing less than $20 on average, were up to two times as likely to prescribe the promoted brand-name drugs as physicians who received no meals. Doctors who received multiple meals were up to three times as likely to do so.

“Whether a formal dinner or a brief lunch in a doctor’s office, these encounters are an opportunity for drug company representatives to discuss products with physicians and their staff,” said Adams Dudley, MD, MBA, professor of medicine and director of the Center for Healthcare Value at the Philip R. Lee Institute for Health Policy Studies at UCSF, and the senior scientist on the study. “The meals may influence physicians’ prescribing decisions.”

Working with Dudley, Colette DeJong, a UCSF medical student, and Thomas Aguilar, MS, a UCSF statistician, took the lead in designing the study, collecting and analyzing data and writing up the study results for publication.

“A lot of the financial burden of using brand-name drugs instead of generic drugs falls on the seniors enrolled in Medicare, who pay an average monthly co-pay of $40 to $80 for brand-name drugs, but only $1 for generics,” said DeJong.

The UCSF study was made possible by public disclosures of payments from manufacturers to physicians that have been required since August 1, 2013, under the Physician Payments Sunshine Act, which is part of the Affordable Care Act.

While recent studies have shown that doctors who receive large payments from drug companies, such as speaking fees or royalties, are more likely to prescribe expensive brand-name drugs, the new study is the first to find an association between single meals and the prescribing behavior of physicians.

Before examining industry payments, the UCSF researchers first identified physicians from the 2013 Medicare Part D Prescriber file who wrote more than 20 prescriptions in any of four common drug classes. These included statins to lower cholesterol levels; beta-blockers, most often used to treat high blood pressure; angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs), also used to treat high blood pressure; and selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), approved for treatment of depression.

The researchers identified the most-prescribed brand-name drug in each category: the statin rosuvastatin, the beta-blocker nebivolol, the ARB olmesartan, and the SNRI desvenlafaxine. They then identified physicians who received industry-sponsored meals promoting one of the drugs.

The 279,669 physicians selected from the Medicare database based on the prescribing criteria received 63,524 payments associated with the four target drugs. Ninety-five percent of payments were for meals, at an average cost of less than $20. Within each of the four classes of drugs, the researchers found physicians who received just one industry-sponsored meal were more likely to prescribe the drug the sales reps were promoting instead of cheaper, generic alternatives.

The design of the study, involving the examination of a cross-section of data over a single time frame, did not enable the researchers to conclude that the free meals caused physicians to prescribe the drugs that were being marketed, only that there was a strong association between the two events.

The generics in these drug classes are thought to be as effective as brand-name drugs, and many insurers limit coverage for the more expensive drugs that are still under patent. The Department of Veterans Affairs does not include any of these brand-name drugs on its formulary.

“Our data raises questions about current practices, but it’s also worth noting that there is not yet a standardized way to get drug information out to doctors,” Dudley said. “The FDA, Medicare, or insurers could set up alternative means of educating doctors about drug developments, but they haven’t done that yet. Given how much extra money they are spending on brand-name drugs, either Medicare or insurers would certainly see plenty of savings even if they were to pay the full cost of an educational program about when and how to use new drugs.”

Other UCSF contributors to the JAMA Internal Medicine study were Grace Lin, MD, MAS, Assistant Professor of Medicine, and W. John Boscardin, PhD, Professor of Epidemiology and Biostatistics. In addition, Chien-Wen Tseng, MD, MPH, Associate Professor of Family Medicine and Community Health at the University of Hawaii John A. Burns School of Medicine, contributed to the study.

Funding was provided by the National Center for Advancing Translational Sciences, National Institutes of Health, and by the Hawaii Medical Service Association Endowed Chair in Health Services and Quality Research at the University of Hawaii.

Written by Laura Kurtzman

UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise. It also includes UCSF Health, which comprises top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospitals in San Francisco and Oakland – and other partner and affiliated hospitals and healthcare providers throughout the Bay Area.

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With a Free Meal from Pharma, Doctors Are More Likely to Prescribe Brand-Name Drugs, Study Shows

Peanut allergy prevention strategy does not impact breastfeeding or nutrition, study shows

Introducing peanut-containing foods during infancy as a peanut allergy prevention strategy does not compromise the duration of breastfeeding or affect children’s growth and nutritional intakes, new findings show. The work, carried out by researchers at King’s College London and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is published today in the Journal of Allergy and Clinical Immunology.

These findings are a secondary result from the Learning Early About Peanut Allergy (LEAP) clinical trial. Primary results from the LEAP trial, published in 2015, found that introducing peanut products into the diets of infants deemed at high risk for peanut allergy led to an 81 percent relative reduction in subsequent development of the allergy compared to avoiding peanut altogether. The goal of the current analysis was to determine whether eating high doses of peanut products beginning in infancy would have any adverse effects on infant and child growth and nutrition.

At the beginning of the LEAP trial, investigators randomly assigned 640 infants enrolled from Evelina London Children’s Hospital, aged 4 to 11 months living in the United Kingdom to regularly consume at least 2 grams of peanut protein three times per week or to avoid peanut entirely. These regimens were continued until the children were 5 years old. The researchers monitored the children at recurring health care visits, and asked their parents and caregivers to complete dietary questionnaires and food diaries.

'An important and reassuring finding of this new analysis was that peanut consumption did not affect the duration of breastfeeding, so countering concerns that introduction of solid foods before six months of age could reduce breastfeeding duration,’ said lead author Mary Feeney, Senior Dietician at the Department of Paediatric Allergy, King’s College London and Guy’s and St. Thomas’ NHS Foundation Trust.

In addition, the researchers did not observe differences in height, weight or body mass index—a measure of healthy weight status—between the peanut consumers and avoiders at any point during the study. This was true even when the researchers compared the subgroup of children who consumed the greatest amount of peanut protein with those who avoided peanut entirely.

In general, the peanut consumers easily achieved the recommended level of 6 grams of peanut protein per week, consuming 7.5 grams weekly on average. They made some different food choices than the avoiders, investigators noted. For example, consumers ate fewer chips and savory snacks. Both groups had similar total energy intakes from food and comparable protein intakes, although the peanut consumers had higher fat intakes and avoiders had higher carbohydrate intakes.

Dr George Du Toit, Consultant in Paediatric Allergy at Evelina London Children’s Hospital and Honorary Reader in Paediatric Allergy, King’s College London, who also led the study said: ‘This study shows that peanut consumption is nutritionally safe when introduced in infancy, even when consumption occurs at high levels. Parents and caregivers must be reminded that whole peanuts should not be given to children below five years due to the risk of choking.’

ENDS

Notes to editors

For more information, please contact Hannah Bransden the King’s College London press office on 020 7848 3820, [email protected]

Reference: M Feeney et al. Impact of peanut consumption in the LEAP study: feasibility, growth and nutrition is published online in the Journal of Allergy and Clinical Immunology on Friday 10 June 2016. DOI: 10.1016/j.jaci.2016.04.016 (2016).

This work was supported by NIAID under award numbers UM1AI109565, NO1-AI-15416 and HHSN272200800029C. Other organizations providing support include Food Allergy Research & Education, the Medical Research Council & Asthma UK Centre and the UK Department of Health. Additional details about the LEAP study are available at ClinicalTrials.gov using the identifier NCT00329784.

For more information about the National Institutes of Health (NIH)  and its programs, visit www.nih.gov

Evelina London Children’s Hospital is part of Guy’s and St Thomas’ NHS Foundation Trust. For more information about Evelina London Children’s Hospital please visit http://ift.tt/1ZErx7k

Guy’s and St Thomas’ is part of King’s Health Partners Academic Health Sciences Centre (AHSC), a collaboration between King’s College London, and Guy’s and St Thomas’, King’s College Hospital and South London and Maudsley NHS Foundation Trusts. http://ift.tt/TgxdSQ.

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Peanut allergy prevention strategy does not impact breastfeeding or nutrition, study shows

‘Inexpensive Old Drug’ May Prevent Birth Damage in High-Risk Newborns, Study Shows

Scans, Skills Testing Indicate Improved Neurodevelopment in Some Treated Children

A 27-year-old drug for anemia may protect newborns at high risk for brain damage, according to the results of a multisite trial led by researchers at UC San Francisco.

Each year more than 800,000 deaths worldwide and many thousands of cases of permanent brain damage in the U.S. are attributed to hypoxic-ischemic encephalopathy (HIE), a dysfunction of the nervous system caused by birth complications resulting in a drop in oxygen supply and inadequate blood flow to the brain and other organs.

Standard of care for HIE is hypothermia in which the head or whole body is cooled to 33.5ºC (92.3ºF) in order to accelerate healing. But hypothermia doesn’t save all patients.

“More than 40 percent of infants will die or suffer moderate to severe disabilities, including cerebral palsy, intellectual impairment and epilepsy,” said Yvonne Wu, a child neurologist and professor of Neurology and Pediatrics at UCSF Benioff Children’s Hospital San Francisco, and lead author of the study. “We wanted to find something that could amplify effectiveness.”

In a phase II trial conducted at seven hospitals throughout the nation, the researchers compared outcomes in 26 full-term newborns with HIE, who were treated with hypothermia and placebo, to 24 who were treated with both hypothermia and five infusions of EPO, or erythropoietin, a man-made version of a natural hormone that stimulates the production of red blood cells.

MRIs Show Fewer Incidences of Brain Injury

The drug was approved by the Food and Drug Administration in 1989 to treat anemia in patients with chronic renal failure. It was later prescribed for children and infants. Previous studies have shown that EPO is an anti-inflammatory and fights apoptosis or cell death. Additionally, it has been demonstrated to promote the development of nervous tissue and tissue remodeling after oxygen deprivation.

When the MRIs of the treated newborns were examined at an average 5 days of age, eight in the EPO group (33.3 percent) were found to have no brain injury, versus three in the placebo group (11.5 percent). One infant in the EPO group had a severe or moderate injury compared with 11 such injuries in the placebo group.

The findings appear in the May 3, 2016, issue of the journal Pediatrics.

The researchers conducted testing at 12 months of age and found that the EPO-treated group developed superior motor skills compared to the non-EPO treated cohort, but these results are preliminary and need to be confirmed, Wu cautioned.

“There is a large range of normal development at age 1. Some children are walking independently while others won’t achieve this for weeks or months. As the children grow older, testing of motor, language and social cognition will become more meaningful,” she said.

Two deaths occurred in the EPO-treated newborns, versus five in the placebo group – a difference that was not clinically significant due to the low number of infants in the trial. Serious adverse effects were reported in nine newborns, but were evenly distributed in both groups and none were attributed to EPO, said Wu.

‘Strong Suggestion that Patients are Doing Better’

“It is clear that this therapy is safe as used in this study and there is a strong suggestion that the patients are doing better than would be expected long term,” said senior author Roberta Ballard, MD, a neonatologist and professor of Pediatrics at UCSF Benioff Children’s Hospital San Francisco. “It would be very encouraging if we find that an inexpensive old drug, costing $60 per infusion, rather than a new drug that costs more than $2 billion to develop may prevent untold suffering. A larger trial will allow a definitive answer to whether there should be a change in clinical care for this devastating condition.”

HIE occurs in 1 to 3 per 1,000 full-term births. It accounts for 22 percent of annual neonatal deaths worldwide, totaling 814,000 deaths in 2008, according to the Child Health Epidemiology Reference Group of the World Health Organization and the United Nations Children’s Fund.

“We’re hopeful that EPO not only reduces the extent of brain injury, but also allows the brain to be more effective at repairing itself during the recovery process,” Wu said. “While research with more participants is needed to determine whether EPO saves lives, we are heartened by the fact that among those infants that survived, the degree of brain injury was generally less severe than in the placebo group.”

The study was supported by funding from the Thrasher Research Fund. The researchers had no financial conflicts to report.

Co-authors are Elizabeth Rogers, MD, Fernando Gonzalez, MD, and Hannah Glass, MDCM, all of UCSF; Amit Mathur, MD, and Robert McKinstry, MD, of Washington University School of Medicine, St. Louis; Taeun Chang, MD, and An Massaro, MD, of Children’s National Health Systems, Washington, D.C.; Sarah Mulkey, MD, PhD, of University of Arkansas Medical Sciences, Little Rock; Dennis Mayock, MD, Sandra Juul, MD, PhD, Bryan Comstock, MS, Katherine Tan, BS, and Patrick Heagerty, PhD, all of University of Washington, Seattle; Krisa Van Meurs, MD, and Sonia Bonifacio, MD, of Stanford University School of Medicine, Palo Alto, Calif.; Michael Msall, MD, of Comer Children’s Hospital, Chicago; and Lawrence Dong, MD, of Kaiser Santa Clara, Calif.

UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise. It also includes UCSF Health, which comprises top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospitals in San Francisco and Oakland – and other partner and affiliated hospitals and healthcare providers throughout the Bay Area.

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‘Inexpensive Old Drug’ May Prevent Birth Damage in High-Risk Newborns, Study Shows

Americans living longer with disability or health issues, study shows

Findings led by USC University Professor challenge assumptions that increased longevity is a sign of good health

There was a reduction in the proportion of years with disability for people over the age of 65. (Photo/Garry Knight)

Americans are living longer but in poorer health, according to a new study.

The USC-led report examined life expectancy trends and disability rates over a 40-year span from 1970 to 2010. The analysis of U.S. vital statistics found that the average total life span increased for men and women in those 40 years, but so did the proportion of time spent living with a disability.

The study found increased longevity is not necessarily indicative of good health. Most age groups live longer with a disability or other health problem.

“We could be increasing the length of poor-quality life more than good-quality life,” said lead author Eileen Crimmins, USC University Professor and AARP Professor of Gerontology at the USC Davis School of Gerontology. “There are a number of indications that the baby boomer generation that is now reaching old age is not seeing improvements in health similar to the older groups that went before them.”

Only for people aged 65 and older was there a “compression of morbidity” — a reduction in the proportion of years spent with disability.

The findings have implications for policymaking, such as proposals to raise the retirement age for Social Security and Medicare eligibility.

The trends for the last 40 years do not support projections and policies that are based on assumptions of a reduced length of disabled life.

Eileen Crimmins

“Clearly, there is a need to maintain health and reduce disability at younger ages to have meaningful compression of morbidity across the age range,” Crimmins said. “The trends for the last 40 years do not support projections and policies that are based on assumptions of a reduced length of disabled life.”

Life-span findings

The average life span for men increased by 9.2 years to 76.2 years, the researchers found. The number of years they live with a disability increased by 4.7 years while the number of years spent disability-free increased by 4.5 years.

For women, the average life span increased by 6.4 years to 81 years. The number of years that women spend with a disability increased by 3.6 years, exceeding the increase in women’s disability-free life (2.7 years).

“The smaller increase in healthy life than in total life for women was surprising and another indication that American women have not done as well as American men in terms of improving health in recent decades,” Crimmins said.

Different factors may affect disability at different ages. For instance, younger populations may have had an increase in disability because of a greater emphasis on mental health, increased diagnoses of autism spectrum and attention-deficit hyperactivity disorders, as well as changes in drug use.

The study was published online April 13 in the American Journal of Public Health. Yuan Zhang of USC Davis and Yasuhiko Saito, a USC graduate and faculty member at Nihon University, were co-authors.

The study was supported by a grant from the U.S. National Institute on Aging (P30-AG17265) and a Special Research Grant by the Japan Ministry of Health, Labour and Welfare (H26-Tokubetsu-Shitei-029).

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Americans living longer with disability or health issues, study shows

Nurse Interactions with Medical Industry are Common but Need Regulation, Study Shows

The study appears in the April 5, 2016, issue of Annals of Internal Medicine.

“We found that, contrary to popular opinion, nurses are highly influential targets for marketing, and they likely interact with sales representatives on a daily basis,” said lead author Quinn Grundy, RN, PhD, a recent graduate of the UCSF School of Nursing and now a postdoctoral research associate at the Charles Perkins Centre at the University of Sydney. “The assumption that because nurses do not prescribe medications, marketing to them must not really matter, serves to make these relationships entirely invisible to the public eye.”

While not able to prescribe medications, nurses still influence patient treatment through physician consultation and patient teaching. Nurses also research, evaluate and select medical products, devices and equipment for hospital purchase.

The disclosure of physicians’ personal financial ties to industry has become the standard for addressing health care conflicts of interest. Legislation has brought transparency to these relationships in an attempt to restore public trust and deter conflicts of interest associated with the increased prescribing of brand name, high-cost medications and devices and the underuse of older, still high-quality medications.

However, payment disclosures largely fail to capture the complexity of daily interactions between industry representatives and health professionals that are built into clinical practice and are often part of the job, the researchers report. In addition, the disclosures focus only on physicians, not registered nurses, the largest proportion of health professionals.

Nurse Relationships Similar to Prescribers

In their study, Grundy and her colleagues interviewed 72 participants with direct experience with industry – staff nurses, administrators, and industry and supply chain professionals – between January 2012 and October 2014 at four acute care hospitals in the metropolitan area of a large western U.S. city and at the annual conference of the American Association of Critical Care Nurses. The study included observations (shadowing and attendance at meetings and sponsored events), in-depth individual interviews, four focus groups, and content analysis of marketing materials and hospital policies.

The researchers found that all 56 nurses in the study interacted with industry in the past year, on average 13 times. One-on-one meetings with sales representatives were the most common interaction, along with sponsored lunches, dinners or events; gift offers; product samples; and paid participation in market research, speakers’ bureaus or consulting. Most interactions were with the medical device industry, followed by the pharmaceutical, health technology and infant formula industries.

Of the 56 nurses, 33 acknowledged benefits of working with representatives, and more than a quarter (16) said it would be impossible to do their jobs without industry resources. Thirty-nine (39) reported challenges with these relationships.

For the overall study, administrators at eight institutions initially were approached to participate. However, most asserted nurse-industry interactions did not occur at their hospitals and nurses did not have much interface with industry.

Further bolstering the belief that marketing to nurses does not occur is the sense that there is no point marketing to clinicians who cannot prescribe. But 46 of the 72 participants evaluated provided concrete examples where nurses had influenced treatment and purchasing decisions.

Overall, Grundy and her colleagues found nurses’ external financial relationships with industry were very similar to those reported by prescribers, but the most significant interactions occurred in daily practice, such as patient care and continuing education. The current policy environment makes these interactions “invisible,” leaving nurses with little guidance to ensure the boundary between service and sales stayed intact.

Changes Needed in Policy, Professions

To remedy these invisible interactions, the researchers in this study recommended amending current institutional policy to include all disciplines, ensuring a more comprehensive approach to controlling marketing influence within clinical settings. Nurses should be included in development of university and hospital industry relations policy to ensure it is relevant to their practice. Hospital administrators also need to recognize and support nurses’ work with industry.

Further, the nursing profession should take a leadership role in supporting nurses’ work with industry by incorporating it into a professional code of ethics, adopting a conflict of interest policy in nursing schools and professional associations, and incorporating preparation for interacting with industry in teaching curricula.

For industry, the roles for support personnel must be clearly defined, and staff need regular training to ensure boundaries are maintained, especially around patient care. Industry-delivered education should be supervised by hospital staff.

Additional research is needed to determine the frequency and prevalence of nurse-industry interactions; the impact at non-academic, private, not-for-profit hospitals; and whether these nurse-industry interactions occur globally.

“Nurse-industry interactions may be commonplace and influential, but they remain invisible in this policy climate,” Grundy said. “While some aspects of these interactions may be beneficial, others may pose financial risks to hospitals or safety risks to patients. Disclosure strategies alone will not provide health professionals with adequate support to manage day-to-day interactions. Management of industry interactions must include nurses’ interactions with industry.”

Other contributors to the Annals of Internal Medicine study were senior author Ruth Malone, RN, PhD, FAAN, professor and chair of social and behavioral sciences in the UCSF School of Nursing; and Lisa Bero, PhD, of the Charles Perkins Centre at the University of Sydney. Funding was provided by the Canadian Institutes of Health Research Doctoral Research Award and grant R36HS022383 from the Agency for Healthcare Research and Quality. Grundy was supported by the UCSF Graduate Dean’s Health Science Fellowship.

UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy, a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences, as well as a preeminent biomedical research enterprise and UCSF Health, which includes two top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospital San Francisco, as well as other partner and affiliated hospitals and healthcare providers throughout the Bay Area. 

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Nurse Interactions with Medical Industry are Common but Need Regulation, Study Shows