PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Trials involving switching HIV drugs may not be beneficial to participants

2012-07-18
(Press-News.org) A increasingly used type of HIV study which involves switching patients on one type of antiretroviral therapy (ART) to another, to see whether the new drug is as good as the at preventing replication of the HIV virus, may be unethical, according to a new Essay published in this week's PLoS Medicine. The studies, termed non-inferiority trials, are only ethical if participants can meaningfully benefit from the treatment change and are more likely to benefit than suffer harm, according to Andrew Carr from the HIV unit in St Vincent's Hospital in Sydney, Australia, Jennifer Hoy from the infectious diseases unit in Alfred Hospital in Melbourne, Australia, and Anton Pozniak from the Chelsea and Westminster Hospital in London, UK. The authors argue in their essay that such trials are not in the best interests of patients, especially as often, these trials have inadequate numbers to assess the key expected benefit and reports all outcomes.

The authors say: "There are several potential advantages and disadvantages for patients of switching or simplifying ART. Potential advantages include reduced toxicity, pill burden, or cost. One key potential disadvantage is that effective, well-tolerated ART is abandoned."

The authors argue that such trials often enrol patients who cannot benefit with the switch, do not capture or report all potential risks, and are designed with a view to a pharmaceutical company's profits rather than participant benefit. They make a strong case for measuring, analysing and reporting relevant disadvantages of the switch and argue that patients must be informed about all potential advantages and disadvantages.

The authors conclude: "Switching ART regimens when virologically suppressed may be appropriate for many reasons, but the full risk–benefit profile should be determined beforehand. The diminishing antiretroviral drug pipeline suggests greater care will need to be given in coming years to extending the benefits of existing drugs for what is likely to remain lifelong therapy."

### Funding: AC is supported by a Practitioner Fellowship of the Australian National Health and Medical Research Council, which had no role in manuscript conception, decision to publish, or preparation of the manuscript. No specific funding was received to write this article.

Competing Interests: AC is a member for the PLoS Medicine Editorial Board. AC has received research funding from Baxter, GlaxoSmithKline/ViiV Healthcare, Merck, and Pfizer; consultancy fees from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, and Merck; lecture and travel sponsorships from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, and Merck; and has served on advisory boards for Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche. AC is funded in part by a Practitioner Fellowship of the Australian National Health and Medical Research Council. AC (but not JH or AP) was an investigator in the SWITCHMRK trial; no author participated in the MONET trial. AC has recently received research funding for a clinical trial sponsored by Gilead Sciences. JH's institution has received research funding from GlaxoSmithKline/ViiV Healthcare, Gilead Sciences, and Merck; travel sponsorship from Gilead Sciences, Janssen-Cilag, and Merck; and JH has served on advisory boards for Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Janssen-Cilag, Merck, and Roche. AP has received consultancy fees from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche; lecture and travel sponsorships from Abbott, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, and Merck; and has served on advisory boards for Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche and has received research funding from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Merck, and Roche. No pharmaceutical company was involved in the writing this paper or decision to publish.

Citation: Carr A, Hoy J, Pozniak A (2012) The Ethics of Switch/Simplify in Antiretroviral Trials: Non-Inferior or Just Inferior? PLoS Med 9(7): e1001240. doi:10.1371/journal.pmed.1001240

CONTACT:

Andrew Carr
St Vincent's Hospital
Sydney, Australia
acarr@stvincents.com.au


ELSE PRESS RELEASES FROM THIS DATE:

Vitamin E may lower liver cancer risk

2012-07-18
High consumption of vitamin E either from diet or vitamin supplements may lower the risk of liver cancer, according to a study published July 17 in the Journal of the National Cancer Institute. Liver cancer is the third most common cause of cancer mortality in the world, the fifth most common cancer found in men and the seventh most common in women. Approximately 85% of liver cancers occur in developing nations, with 54% in China alone. Some epidemiological studies have been done to examine the relationship between vitamin E intake and liver cancer; however, the results ...

Hospitals' stroke-care rankings change markedly when stroke severity is considered

2012-07-18
As part of the Affordable Care Act, hospitals and medical centers are required to report their quality-of-care and risk-standardized outcomes for stroke and other common medical conditions. But reporting models for mortality that don't consider stroke severity may unfairly skew these results. Now, A UCLA-led national study has found that when reporting on 30-day mortality rates for Medicare beneficiaries hospitalized with acute stroke, using a model that adjusts for stroke severity completely alters performance outcomes and rankings for many hospitals. The new findings, ...

Including stroke severity in risk models associated with improved prediction of risk of death

2012-07-18
CHICAGO – Adding stroke severity to a hospital 30-day mortality model based on claims data for Medicare beneficiaries with acute ischemic stroke was associated with improvement in predicting the risk of death at 30 days and changes in performance ranking regarding mortality for a considerable proportion of hospitals, according to a study in the July 18 issue of JAMA. "Increasing attention has been given to defining the quality and value of health care through reporting of process and outcome measures. National quality profiling efforts have begun to report hospital-level ...

Treating chronic hepatitis C with milk thistle extract does not appear beneficial

2012-07-18
CHICAGO – Use of the botanical product silymarin, an extract of milk thistle that is commonly used by some patients with chronic liver disease, did not provide greater benefit than placebo for patients with treatment-resistant chronic hepatitis C virus (HCV) infection, according to a study in the July 18 issue of JAMA. Chronic hepatitis C virus infection affects almost 3 percent of the global population and may lead to cirrhosis, liver failure, and liver cancer. A large proportion of patients do not respond to certain treatments for this infection, and many others cannot ...

Stress fuels breast cancer metastasis to bone

2012-07-18
Stress can promote breast cancer cell colonization of bone, Vanderbilt Center for Bone Biology investigators have discovered. The studies, reported July 17 in PLoS Biology, demonstrate in mice that activation of the sympathetic nervous system – the "fight-or-flight" response to stress – primes the bone environment for breast cancer cell metastasis. The researchers were able to prevent breast cancer cell lesions in bone using propranolol, a cardiovascular medicine that inhibits sympathetic nervous system signals. Metastasis – the spread of cancer cells to distant organs, ...

Study examines variation, factors involved with patient-sharing networks among physicians in US

2012-07-18
CHICAGO – Physicians tend to share patients with colleagues who have similar personal traits and practice styles, and there is substantial variation in physician network characteristics across geographic areas, according to a study in the July 18 issue of JAMA. Physicians are embedded in informal networks that result from their sharing of patients, information, and behaviors. "These informal information-sharing networks of physicians differ from formal organizational structures (such as a physician group associated with a health plan, hospital, or independent practice ...

Treatment of multiple sclerosis with interferon beta not linked with less progression of disability

2012-07-18
CHICAGO – Among patients with relapsing-remitting multiple sclerosis (MS), treatment with the widely-prescribed drug to treat MS, interferon beta, was not associated with less progression of disability, according to a study in the July 18 issue of JAMA. "A key feature of MS is clinical progression of the disease over time manifested by the accumulation of disability. Interferon beta drugs are the most widely prescribed disease-modifying drugs approved by the U.S. Food and Drug Administration for the treatment of relapsing-onset MS, the most common MS disease course," ...

Physicians' focus on risks for stroke and dementia saved lives, money

2012-07-18
Fewer people died or needed expensive long-term care when their physicians focused on the top risk factors for stroke and dementia, according to research reported in the Journal of the American Heart Association (JAHA). dementia The primary care doctors in the German study focused on high blood pressure, smoking, high cholesterol, diabetes, irregular heartbeat (atrial fibrillation) and depression. The researchers found that during a five-year period, the need for long-term care was cut 10 percent in women and 9.6 percent in men. Based on data collected in a comparison ...

Mammography screening shows limited effect on breast cancer mortality in Sweden

2012-07-18
Breast cancer mortality statistics in Sweden are consistent with studies that have reported that screening has limited or no impact on breast cancer mortality among women aged 40-69, according to a study published July 17 in the Journal of The National Cancer Institute. Since 1974, Swedish women aged 40-69 have increasingly been offered mammography screening, with nationwide coverage peaking in 1997. Researchers set out to determine if mortality trends would be reflected accordingly. In order to determine this, Philippe Autier, M.D., of the International Prevention ...

Penn expert addresses ethical implications of testing for Alzheimer's disease risk

2012-07-18
VANCOUVER – Diagnostic tests are increasingly capable of identifying plaques and tangles present in Alzheimer's disease, yet the disease remains untreatable. Questions remain about how these tests can be used in research studies examining potential interventions to treat and prevent Alzheimer's disease. Experts from the Perelman School of Medicine at the University of Pennsylvania will today participate in a panel at the Alzheimer's Association International Conference 2012 (AAIC 2012) discussing ways to ethically disclose and provide information about test results to asymptomatic ...

LAST 30 PRESS RELEASES:

Thirty-year mystery of dissonance in the “ringing” of black holes explained

Less intensive works best for agricultural soil

Arctic rivers project receives “national champion” designation from frontiers foundation

Computational biology paves the way for new ALS tests

Study offers new hope for babies born with opioid withdrawal syndrome

UT, Volkswagen Group of America celebrate research partnership

New Medicare program could dramatically improve affordability for cancer drugs – if patients enroll

Are ‘zombie’ skin cells harmful or helpful? The answer may be in their shapes

University of Cincinnati Cancer Center presents research at AACR 2025

Head and neck, breast, lung and survivorship studies headline Dana-Farber research at AACR Annual Meeting 2025

AACR: Researchers share promising results from MD Anderson clinical trials

New research explains why our waistlines expand in middle age

Advancements in muon detection: Taishan Antineutrino Observatory's innovative top veto tracker

Chips off the old block

Microvascular decompression combined with nerve combing for atypical trigeminal neuralgia

Cutting the complexity from digital carpentry

Lung immune cell type “quietly” controls inflammation in COVID-19

Fiscal impact of expanded Medicare coverage for GLP-1 receptor agonists to treat obesity

State and sociodemographic trends in US cigarette smoking with future projections

Young adults drive historic decline in smoking

NFCR congratulates Dr. Robert C. Bast, Jr. on receiving the AACR-Daniel D. Von Hoff Award for Outstanding Contributions to Education and Training in Cancer Research

Chimpanzee stem cells offer new insights into early embryonic development

This injected protein-like polymer helps tissues heal after a heart attack

FlexTech inaugural issue launches, pioneering interdisciplinary innovation in flexible technology

In Down syndrome mice, 40Hz light and sound improve cognition, neurogenesis, connectivity

Methyl eugenol: potential to inhibit oxidative stress, address related diseases, and its toxicological effects

A vascularized multilayer chip reveals shear stress-induced angiogenesis in diverse fluid conditions

AI helps unravel a cause of Alzheimer's disease and identify a therapeutic candidate

Coalition of Autism Scientists critiques US Department of Health and Human Services Autism Research Initiative

Structure dictates effectiveness, safety in nanomedicine

[Press-News.org] Trials involving switching HIV drugs may not be beneficial to participants