Showing posts with label guidelines. Show all posts
Showing posts with label guidelines. Show all posts

Friday, 16 August 2013

NAS panel 'misled the world' when adopting radiation exposure guidelines, Toxicologist says

Main Category: Radiology / Nuclear Medicine
Article Date: 15 Aug 2013 - 1:00 PDT Current ratings for:
NAS panel 'misled the world' when adopting radiation exposure guidelines, Toxicologist says
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Toxicologist Edward Calabrese reviews how a linear dose-response approach to ionizing radiation exposure was adopted and offers evidence supporting his view that 2 geneticists suppressed evidence to keep the NAS from considering a non-linear model

In two recently published peer-reviewed articles, toxicologist Edward Calabrese of the University of Massachusetts Amherst describes how regulators came to adopt the linear no threshold (LNT) dose-response approach to ionizing radiation exposure in the 1950s, which was later generalized to chemical carcinogen risk assessment.

He also offers further evidence to support his earlier assertions that two geneticists deliberately suppressed evidence to prevent the U.S. National Academy of Sciences (NAS) from considering an alternative, threshold model, for which there was experimental support. Calabrese's articles appear in two issues of Archives of Toxicology.

Calabrese says, "The regulatory research community needs to hear about this. This isn't an academic debate; it's practical, because all of our rules about chemical and low-level radiation are based on unvalidated assumptions and scientific panel decisions made without sound evidence. Now, after all these years, it's very hard when people have been frightened to death of any exposure whatsoever, to persuade them that we don't need to be scared by certain low-dose exposures."

The first of Calabrese's recent articles is a straightforward history of the LNT model for ionizing radiation mutation, a concept accepted by radiation geneticists in the 1950s and recommended by national and international advisory committees for risk assessment and human exposure guidelines and later generalized to chemical carcinogens ever since. It is now used by public health and regulatory agencies worldwide, he notes.

In the second of the two articles, Calabrese repeats his earlier accusations that the distinguished radiation geneticist Hermann Muller, in his acceptance speech for the 1946 Nobel Prize, "made deceptive statements" intended to "promote the acceptance of the linear dose-response model for risk assessment for ionizing radiation" and that Muller's advocacy agenda was "masked" by long-time colleague Curt Stern. Their actions affected "key publications in the mutation literature," enhancing acceptance of the linear dose-response and hiding "Muller's deceptions," Calabrese adds.

His own career-long research on hormesis, which is a non-linear, threshold-based or biphasic approach to dose-response and risk assessment for ionizing radiation and toxic chemicals, provides evidence that low-dose exposure of some chemicals and ionizing radiation are benign or even helpful. In three "substantial validation tests" of the threshold, hormesis and linear no-threshold models, Calabrese and colleagues say, "only the hermetic (biphasic) dose-response made consistently accurate predictions."

The UMass Amherst toxicologist has argued for many years that a reappraisal of cancer risk assessment methods is urgently needed because the LNT model was incorporated into U.S. regulatory policy based on faulty assumptions and by Muller and Stern's manipulation of the scientific literature.

Calabrese's interpretation of this history is supported by letters and other materials he has compiled, many from formerly classified files. Muller and Stern had done many of the key experiments contributing to health risk assessment of ionizing radiation and Muller served on NAS's Biological Effects of Atomic Radiation (BEAR) committee through which the linear dose-response approach to risk assessment became firmly entrenched, Calabrese related. He offers further evidence that the two successfully suppressed evidence from a key experiment with fruit fly sperm that challenged their views on dose-response.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our radiology / nuclear medicine section for the latest news on this subject. Please use one of the following formats to cite this article in your essay, paper or report:

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University of Massachusetts at Amherst. "NAS panel 'misled the world' when adopting radiation exposure guidelines, Toxicologist says." Medical News Today. MediLexicon, Intl., 15 Aug. 2013. Web.
15 Aug. 2013. APA

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'NAS panel 'misled the world' when adopting radiation exposure guidelines, Toxicologist says'

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Thursday, 15 August 2013

Conflicts of interest common among panel members of guidelines that expand disease definitions

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 13 Aug 2013 - 14:00 PDT Current ratings for:
Conflicts of interest common among panel members of guidelines that expand disease definitions
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An assessment of expert members of panels making decisions about definitions or diagnostic criteria for common conditions in the US, which were published in guidelines used by physicians and other healthcare professionals caring for patients, found that most members had ties to industry. The assessment was made in a study from Ray Moynihan of Bond University, Queensland, Australia, and colleagues published in this week's issue of PLOS Medicine.

Of the 16 expert panel publications appearing between 2000 and April 2013 that met the authors' criteria of changing disease definitions, 10 proposed changes widening disease definitions and one narrowed a definition. Conditions being expanded included high blood pressure, Alzheimer disease and rheumatoid arthritis. Among the 14 panels with disclosure sections, the average proportion of members with industry ties was 75%.Twelve panels were chaired by people with industry ties. For members with ties, the median number of companies to which they were tied was seven. Companies with the highest proportions of ties manufactured drugs used to treat the disease.

In 2009, a US Institute of Medicine (IOM) report recommended that professional societies and other organizations drafting clinical practice guidelines should "generally exclude as panel members individuals with conflicts of interest," and in 2011 another IOM report recommended furthermore that panel chairs should be free of conflicts. To assess the potential impact of these recommendations, the authors compared panel publications released in 2012 with those released earlier and found no difference--guidelines published in 2012 had an average of 76% of members with ties, vs 74% before 2012.

The authors state, "This study did not investigate the merits of the proposed changes to the conditions identified. However, findings that diagnostic thresholds are being lowered by panels dominated by those with financial ties to multiple companies which may benefit directly from those decisions, raises questions about current processes of disease definition."

A limitation of the study is that the authors did not compare their results with guidelines that did not change disease definitions to determine whether industry ties were more common among panelists of guidelines that changed definitions compared with those that did not. Furthermore, the authors state, "As both [IOM] reports make clear, there are financial as well as non-financial or intellectual conflicts such as academic advancement, and there should be no assumption that having a conflict is unethical, or 'that any particular professional will necessarily let financial gain influence his or her judgment'."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our regulatory affairs / drug approvals section for the latest news on this subject.

Funding: NHMRC Screening and Test Evaluation Program Grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: RM, JD, and PG are involved in planning an international conference called Preventing Overdiagnosis. GC is a board member of General Practice Education and Training, Ltd; a registrar for the Medical Administration of the Princess Alexandra Hospital in Brisbane, Australia; and a former board member of the Royal Australian College of General Practitioners. SH is a member of the PLOS Medicine editorial board and chairs the Australian Pharmaceutical Benefits Advisory Committee, an independent advisory body for the Australian government. LB declares that no competing interests exist.

Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Crosssectional Study of Common Conditions in the United States.

PLoS Med 10(8): e1001500. doi:10.1371/journal.pmed.1001500

Moynihan RN, Cooke GP, Doust JA, Bero L, Hill S, et al.

PLOS Medicine

Please use one of the following formats to cite this article in your essay, paper or report:

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Medicine, PLOS. "Conflicts of interest common among panel members of guidelines that expand disease definitions." Medical News Today. MediLexicon, Intl., 13 Aug. 2013. Web.
14 Aug. 2013. APA

Please note: If no author information is provided, the source is cited instead.


'Conflicts of interest common among panel members of guidelines that expand disease definitions'

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Ethical issues are often not addressed in national clinical practice guidelines for dementia

Main Category: Alzheimer's / Dementia
Article Date: 13 Aug 2013 - 14:00 PDT Current ratings for:
Ethical issues are often not addressed in national clinical practice guidelines for dementia
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Twelve national dementia clinical practice guidelines included only half of 31 ethical issues the authors had identified as important in patient care, finds a study by Daniel Strech, of Hannover Medical School, Hannover, Germany, and colleagues, published in this week's issue of PLOS Medicine.

The authors identified current national clinical practice guidelines for dementia care published in English or German. They had previously systematically reviewed ethical issues in dementia care and they used thematic text analysis to assess whether and how the ethical issues were addressed in the guidelines. In the 12 national practice guidelines identified, an average of 49.5% of the 31 ethical issues were addressed (range, 22% to 77%). National guidelines differed substantially with respect to which ethical issues were represented, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were explained.

The clinical practice guidelines were published by a central governmental institution in 6 countries (Australia, France, Malaysia, New Zealand, Singapore, United Kingdom), by a medical association in 4 countries (Canada, Germany, Scotland, United States of America), one by a statutory health insurance body (Austria), and by an expert panel in one country (Switzerland). The authors state, "All guidelines explicitly acknowledged the involvement of experts from different specialties (most often from psychiatry, neurology, gerontology, and family medicine)."

Four (13%) ethical issues were not addressed in at least 11 out of 12 CPGs: "Adequate consideration of existing advance directives in medical decision making.", "Usage of GPS and other monitoring techniques ", "Covert medication" and "Dealing with suicidality."

The authors conclude, "Ethical issues and how to deal with them are important for guidelines to address, for the medical profession to understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines."

Furthermore, although clinical practice guidelines are "meant to improve standards of clinical competence and professionalism by referring explicitly to evidence-based information on benefits and harms", the authors state that clinical practice guideline development manuals worldwide fail to address how to include disease-specific ethical issues.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our alzheimer's / dementia section for the latest news on this subject.

This work has been funded by the German Research Foundation (DFG) through the research project Ethics Guide (STR 1070/2-1). The article processing charge was funded by means of the DFG-Project ‘‘Open Access Publishing’’ by the German Research Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis

PLoS Med 10(8): e1001498. doi:10.1371/journal.pmed.1001498

Knüppel H, Mertz M, Schmidhuber M, Neitzke G, Strech D (2013)

PLOS Medicine

Please use one of the following formats to cite this article in your essay, paper or report:

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Medicine, PLOS. "Ethical issues are often not addressed in national clinical practice guidelines for dementia." Medical News Today. MediLexicon, Intl., 13 Aug. 2013. Web.
14 Aug. 2013. APA

Please note: If no author information is provided, the source is cited instead.


'Ethical issues are often not addressed in national clinical practice guidelines for dementia'

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View the original article here

Friday, 26 July 2013

Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today

Main Category: Liver Disease / Hepatitis
Also Included In: Alcohol / Addiction / Illegal Drugs
Article Date: 25 Jul 2013 - 1:00 PDT Current ratings for:
Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today
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The burden of liver disease could be dramatically reduced by increasing treatment for hepatitis C infection among people who inject drugs, suggest new recommendations developed by researchers from the Kirby Institute at UNSW, in collaboration with colleagues from the International Network on Hepatitis Care in Substance Users (INHSU).

In Australia, 226,000 people are living with chronic hepatitis C and over 10,000 new cases are reported every year. Hepatitis C can lead to serious liver complications such as liver failure or cancer, which are associated with considerable costs to the health care system. Although almost 80 per cent of all infections occur among people who inject drugs, only one per cent of these people currently receive treatment.

"Treatment for hepatitis C infection among people who inject drugs remains unacceptably low," said Dr Jason Grebely, Senior Lecturer at the Kirby Institute, UNSW, and co-lead author of the recommendations. "Clinicians have been hesitant to recommend treatment in this population because of a lack of understanding about how lifestyle factors may impede successful treatment."

But research supporting the first set of international recommendations ever released for treating hepatitis C in people who inject drugs has shown that treatment can be very successful when barriers are addressed within a supportive environment.

"Reducing the significant burden of liver disease related to hepatitis C in Australia and internationally will require improved assessment and treatment of the population most affected: people who currently inject drugs and those who have injected drugs in the past," says Philip Bruggmann, President of INHSU. "By providing appropriate care to this group, we can reduce the burden of hepatitis C-related liver disease in this vulnerable population and slow the spread of this world-wide epidemic. These new recommendations serve as a first step towards elimination of hepatitis C."

The global recommendations are published online today in the journal Clinical Infectious Diseases ahead of World Hepatitis Day on July 28. They are part of a supplement entitled "Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs: Moving the Agenda Forward", developed in collaboration with INHSU.

Additional Stakeholder Comments:

"These are exceptionally positive and welcome findings. Following the listing of new hep C treatments for subsidy by the Australian Government in April, almost all people in Australia living with hepatitis C in Australia can enjoy cure rates of around 75 to 80 per cent. This new evidence shows us that people who have been least able to access treatment in the past, can and should be able to benefit from these new treatment advances."

Stuart Loveday
CEO of Hepatitis NSW

"This report is most welcomed. It finally provides the much needed endorsement that peer support requires to validate it as an efficacious treatment modality. That combined with the recognition that people who continue to inject or use drugs can access treatment will mean that more people will be able to access treatment. For too long those most affected by hepatitis C have been on the periphery, this report puts them where they belong - front and centre."

Nicky Bath
CEO of the NSW Users and AIDS Association

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our liver disease / hepatitis section for the latest news on this subject. Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Institute, Kirby. "Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today." Medical News Today. MediLexicon, Intl., 25 Jul. 2013. Web.
26 Jul. 2013. APA
Institute, K. (2013, July 25). "Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263862.php.

Please note: If no author information is provided, the source is cited instead.


'Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam). We reserve the right to amend opinions where we deem necessary.

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.



View the original article here

Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today

Main Category: Liver Disease / Hepatitis
Also Included In: Alcohol / Addiction / Illegal Drugs
Article Date: 25 Jul 2013 - 1:00 PDT Current ratings for:
Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today
not yet ratednot yet rated

The burden of liver disease could be dramatically reduced by increasing treatment for hepatitis C infection among people who inject drugs, suggest new recommendations developed by researchers from the Kirby Institute at UNSW, in collaboration with colleagues from the International Network on Hepatitis Care in Substance Users (INHSU).

In Australia, 226,000 people are living with chronic hepatitis C and over 10,000 new cases are reported every year. Hepatitis C can lead to serious liver complications such as liver failure or cancer, which are associated with considerable costs to the health care system. Although almost 80 per cent of all infections occur among people who inject drugs, only one per cent of these people currently receive treatment.

"Treatment for hepatitis C infection among people who inject drugs remains unacceptably low," said Dr Jason Grebely, Senior Lecturer at the Kirby Institute, UNSW, and co-lead author of the recommendations. "Clinicians have been hesitant to recommend treatment in this population because of a lack of understanding about how lifestyle factors may impede successful treatment."

But research supporting the first set of international recommendations ever released for treating hepatitis C in people who inject drugs has shown that treatment can be very successful when barriers are addressed within a supportive environment.

"Reducing the significant burden of liver disease related to hepatitis C in Australia and internationally will require improved assessment and treatment of the population most affected: people who currently inject drugs and those who have injected drugs in the past," says Philip Bruggmann, President of INHSU. "By providing appropriate care to this group, we can reduce the burden of hepatitis C-related liver disease in this vulnerable population and slow the spread of this world-wide epidemic. These new recommendations serve as a first step towards elimination of hepatitis C."

The global recommendations are published online today in the journal Clinical Infectious Diseases ahead of World Hepatitis Day on July 28. They are part of a supplement entitled "Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs: Moving the Agenda Forward", developed in collaboration with INHSU.

Additional Stakeholder Comments:

"These are exceptionally positive and welcome findings. Following the listing of new hep C treatments for subsidy by the Australian Government in April, almost all people in Australia living with hepatitis C in Australia can enjoy cure rates of around 75 to 80 per cent. This new evidence shows us that people who have been least able to access treatment in the past, can and should be able to benefit from these new treatment advances."

Stuart Loveday
CEO of Hepatitis NSW

"This report is most welcomed. It finally provides the much needed endorsement that peer support requires to validate it as an efficacious treatment modality. That combined with the recognition that people who continue to inject or use drugs can access treatment will mean that more people will be able to access treatment. For too long those most affected by hepatitis C have been on the periphery, this report puts them where they belong - front and centre."

Nicky Bath
CEO of the NSW Users and AIDS Association

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our liver disease / hepatitis section for the latest news on this subject. Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Institute, Kirby. "Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today." Medical News Today. MediLexicon, Intl., 25 Jul. 2013. Web.
26 Jul. 2013. APA
Institute, K. (2013, July 25). "Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263862.php.

Please note: If no author information is provided, the source is cited instead.


'Treating people who use drugs is the first step towards eliminating hepatitis C - international guidelines for treatment released today'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam). We reserve the right to amend opinions where we deem necessary.

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.



View the original article here