Health and Medical News and Resources

General interest items edited by Janice Flahiff

[Journal article] How Basic Scientists Help the Pharmaceutical Industry Market Drugs

Excerpt from the December 2013 PLoS article by Adriane Fugh-Berman 

In the 1970s, a Baltimore city senator who also owned a tavern backed legislation that helped his business. Accused of having a conflict of interest, Joseph J. Staszak, responded, “What conflict of interest? How does this conflict with my interest?” [1].

According to the Institute of Medicine, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary influence” [2]. More simply, conflicts of interest may be seen as circumstances in which “individuals’ professional responsibilities diverge from their personal interests (or when different professional responsibilities clash)” [3].

In biomedicine, discourse on conflicts of interest (also called competing interests) has focused on relationships between industry and physicians or clinical researchers. However, basic scientists are not immune to industry influence on research and publications, and may be important to industry in the production and dissemination of marketing messages.

Depending on Industry

In 2007, industry was the largest funder of biomedical research, paying for nearly twice as much research (58%) as the federal government (33%) [4]. Most of this funding goes to clinical research; the share of spending by pharmaceutical and device industry on preclinical research has decreased from about half (55%) in 1998 to a quarter (25%) in 2010 [5]. A 2007 survey of 3,080 academic life science researchers found that half (53%) have some form of relationship with industry [6]. Among the 1,663 research faculty at academic medical centers, 42% of basic scientists had a relationship with industry. This number was similar to health services researchers/clinical epidemiologists (40%), but less than clinical researchers (67%) translational researchers (61%), or “multimodal” researchers (71%) [7]. At the 50 universities that received the most NIH research funding, 43% of 2,167 life science researchers reported receiving a research-related gift in the late 1990s [8]. Gifts included biomaterials (24% of respondents), discretionary funds (15%), equipment (11%), travel funds to professional meetings (11%), student support (9%), and other (3%).

Researchers were aware that something was expected in return for the gift. Sponsor expectations that the gift be used for its intended purpose and not be re-gifted, and that the sponsor be acknowledged in publications, are certainly reasonable. Disturbingly, however, about a third (32%) of gift recipients reported that the funder wanted prepublication review of any articles or reports stemming from the use of the gift. This expectation was higher for gifts of biomaterials: 40% of respondents reported that the firm wanted to receive prepublication review of articles or reports. Also, 44% of firms wanted assurances that the biomaterial was not to be used for applications that competed with company products [8].

Industry Funding Affects Results

In clinical research, investigators who receive industry funding are more likely to publish results that favor a sponsor’s marketing goals than are investigators who do not receive industry funding. The Cochrane Collaboration, renowned for creating and publishing high-quality systematic reviews, analyzed 48 clinical studies, systematic reviews, and meta-analyses that compared results from studies of drugs or medical devices based on sponsorship. This systematic review found that industry-sponsored studies, compared to non-industry-sponsored studies, were more likely to report favorable efficacy results for drugs or medical devices; less likely to find harms; and more likely to conclude that a therapy was beneficial [9].

Selective Publication

Selective presentations and publications are important tactics for industry. Industry relies on abstracts and posters to convey marketing messages at scientific meetings, because abstracts and posters are usually not peer-reviewed and can be easily altered up to the time of presentation. Posters and abstracts are often used for preclinical studies, case reports, or preliminary results of clinical trials. Promising preliminary results might be presented as a poster, and the results may be publicized, but if the final results of the study do not support commercial goals, the full study may never be published – or may be buried in an obscure, low-impact journal. In either case, scientists may have a positive impression of a therapy from a poster, and never learn that the therapy failed to show efficacy in the final study.

Perhaps because negative outcomes from industry-funded studies are less likely to be submitted for publication, industry-funded clinical trials overall are less likely to be published. An analysis of 546 drug trials listed in ClinicalTrials.gov found that within two years of study completion, about a third of studies that received full (32%) or partial (39%) industry support were published. In contrast, more than half (54%) of trials funded by government, and 56% of trials funded entirely through nonprofit/nonfederal funds, were published [19].

The majority of meeting abstracts and posters are never published. Posters and abstracts with positive results are far more likely to be published than negative studies [14],[15].

..

Once a drug is on the market, it can be prescribed “off-label” – that is, for any condition other than that for which the drug was approved. Although it is legal for physicians and other prescribers to prescribe a drug off-label, it is illegal for pharmaceutical companies to promote drugs off-label. Off-label use is common, accounting for about one in five prescriptions [23]. It is unknown how much off-label use is due to promotion.

Pharmaceutical companies use paid speakers, consultants, and researchers to promote off-label use [24].

,,,

Companies have paid billions of dollars in fines for off-label promotion, often using company-generated research, company-paid speakers, and ghostwritten articles to imply clinical benefits in the absence of clinical trials (or the presence of negative trials); fines have also been imposed for suppressing risks or misleading clinicians about risks [34].

Read the entire article here

 

December 8, 2013 Posted by | Biomedical Research Resources | , , , , , , , | Leave a comment

Birth is no reason to go to hospital

Accouchement à domicile en piscine à Tahiti

Accouchement à domicile en piscine à Tahiti (Photo credit: Wikipedia)

From the 19 September 2012 article at EurekAlert

A new Cochrane Review concludes that all countries should consider establishing proper home birth services. They should also provide low-risk pregnant women with information enabling them to make an informed choice. The review has been prepared by senior researcher, statistician Ole Olsen, the Research Unit for General Practice, University of Copenhagen, and midwifery lecturer PhD Jette Aaroe Clausen.

In many countries it is believed that the safest option for all women is to give birth in hospital. However, observational studies of increasingly better quality and in different settings suggest that planned home birth in many places can be as safe as planned hospital birth and with less intervention and fewer complications.

“If home birth is going be an attractive and safe option for most pregnant women, it has to be an integrated part of the health care system,” Ole Olsen says and adds, “In several Danish regions the home birth service has been very well organised for several years. This is not the case everywhere in the world.”

The updated Cochrane Review concludes that there is no strong evidence from experimental studies (randomised trials) to favour either planned hospital birth or planned home birth for low-risk pregnant women. At least not as long as the planned home birth is assisted by an experienced midwife with collaborative medical back up in case transfer should be necessary.

Fewer interventions in home birth

Routines and easy access to medical interventions may increase the risk of unnecessary interventions in birth explaining why women who give birth at home have a higher likelihood for a spontaneous labour. There are 20-60 per cent fewer interventions, for example fewer cesarean sections, epidurals and augmentation among those women who plan a homebirth; and 10-30 per cent fewer complications, for example post partum bleeding and severe perineal tears.

“Patience is important if women want to avoid interference and give birth spontaneously,” says Jette Aaroe Clausen. “At home the temptation to make unnecessary interventions is reduced. The woman avoids for example routine electronic monitoring that may easily lead to further interventions in birth.”

Jette Aaroe Clausen adds that interventions in childbirth are common in many countries, but also that there is a growing concern internationally because interventions may lead to iatrogenic effects; iatrogenic effects meaning unintended consequences of the intervention. Routine electronic monitoring may for example lead to more women having artificial rupture of membranes which in turn can lead to more interventions.

Evidence and human rights

While the scientific evidence from observational studies has been growing, the European Court of Human Rights in Strasbourg in the case Ternovszky versus Hungary has handed down a judgment stating that “the right to respect for private life includes the right to choose the circumstances of birth”. This is quoted in the review.

Thus the conclusions of the review are based on human rights and ethics as well as on results from the best available scientific studies.

###

Further information

Ref.: Olsen O, Clausen JA. Planned hospital birth versus planned home birth. The Cochrane Library, Issue 9, 2012.

The full review may be available here (depends on country): http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000352.pub2/abstract

[Check your local medical, academic, and public libraries for access to this article.
Many medical and academic libraries are open to the public. Ask a reference librarian for assistance]

 

Related Resource

  • Cocharane Reviews
    Cochrane Reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care. They investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting. They are published online in The Cochrane Library.

September 19, 2012 Posted by | Consumer Health | , , , , , | Leave a comment

Less Research Is Needed

Research being carried out at the Microscopy l...

Research being carried out at the Microscopy lab of the . This photo was taken on July 28, 2006 using a Nikon D70. For more information about INL’s research projects and career opportunities, visit the lab’s facebook site. http://www.facebook.com/idahonationallaboratory (Photo credit: Wikipedia)

From a thoughtful 25 June 2012 post at The Health Care Blog

he most over-used and under-analyzed statement in the academic vocabulary is surely “more research is needed”.

These four words, occasionally justified when they appear as the last sentence in a Masters dissertation, are as often to be found as the coda for a mega-trial that consumed the lion’s share of a national research budget, or that of a Cochrane review which began with dozens or even hundreds of primary studies and progressively excluded most of them on the grounds that they were “methodologically flawed”.

Yet however large the trial or however comprehensive the review, the answer always seems to lie just around the next empirical corner.

With due respect to all those who have used “more research is needed” to sum up months or years of their own work on a topic, this ultimate academic cliché is usually an indicator that serious scholarly thinking on the topic has ceased. It is almost never the only logical conclusion that can be drawn from a set of negative, ambiguous, incomplete or contradictory data…

June 26, 2012 Posted by | Uncategorized | , , , , | Leave a comment

PubMed Health – A Growing Resource for Clinical Effectiveness Information

Screen capture of PubMed Health homepage.

From the November NLM Technical Bulletin article

PubMed Health — A Growing Resource for Clinical Effectiveness Information

PubMed® Health developed further as a resource for clinical effectiveness research with its August and September 2011 releases. Growing from around 200 items based on systematic reviews to over 5,000, PubMed Health has also begun a collection focused on helping people understand systematic reviews and their results. PubMed Health goals are: helping users find the evidence that could answer their questions about effects of health care and helping them understand what they find.

Making Systematic Reviews More Accessible
Systematic reviews that identify and interpret studies on the effects of health care form an essential research basis for informed decision-making. Systematic reviewing has been growing, especially with the advent of The Cochrane Collaboration and the increasing incorporation of this methodology in health technology assessment by public agencies and clinical practice guideline development.

Systematic reviews (including health technology assessments) are often lengthy and highly technical. Their evolution has been accompanied by a growth in knowledge translation activity. Along with traditional abstracts, various forms have been developed to help people use systematic reviews: executive and policymaker summaries, summaries or other forms for patients/consumers and summaries for clinicians.

However, these materials have been scattered widely on content providers’ Web sites without being collected centrally. Many of the systematic reviews undertaken by public health technology assessment agencies have also remained outside the National Library of Medicine® (NLM®) system. The PubMed Health initiative is gathering them together within a single searchable resource.

PubMed Health Content
PubMed Health contains systematic reviews and summaries of systematic reviews undertaken or updated in roughly the last ten years. The time limit is applied to publication date of around eight years, to allow for the time lag from the date of the evidence search. The cut-off currently is 2003.

New content incorporated in these releases include summaries from The Cochrane Collaboration and the National Health Service (NHS) National Institute for Health Research (NIHR) Health Technology Assessment Programme. There are also full text reviews from the U.S. Agency for Healthcare Research and Quality (AHRQ), the Drug Effectiveness Review Project (DERP) at Oregon Health & Science University (OHSU), England’s National Institute for Health and Clinical Excellence (NICE) guidelines program, and the Department of Veterans Affairs’ Evidence-based Synthesis Program. From NHS Choices comes “Behind the Headlines”, its educational service on the science behind the news. These new content providers join PubMed Health original consumer clinical effectiveness content for consumers content provided by AHRQ and the German Institute for Quality and Efficiency in Health Care (IQWiG).

The reviews and review summaries now in PubMed Health account for perhaps one-third of the good quality systematic reviews published by public agencies and journals worldwide. Most of the remainder can be found in PubMed “Clinical Queries” Systematic Reviews search which runs simultaneously with a PubMed Health search; those PubMed results are presented as links on the right-hand portion of the results page (see #3 in Figure 4).

Organization
The re-designed homepage (see Figure 1) includes four key sections:

  • Contents: a complete alphabetical listing of all titles, sorted by type of content.
  • Behind Headlines: the NHS guide to the science behind health stories in the news.
  • New & updated: content added in the last 60 days.
  • Featured reviews: high quality reviews on interesting topics are selected and featured here. “Previously featured reviews” are provided in an RSS feed to which people can subscribe.
  • Understanding clinical effectiveness: an explanation of clinical effectiveness research along with a section focusing on resources to help people understand systematic reviews and interpret the results.

Screen capture of PubMed Health homepage.
Figure 1: PubMed Health homepage.

A drop-down box under “Contents” (see Figure 2) shows the categories of information currently included in PubMed Health where these are available:

  • For consumers: includes consumer summaries of systematic reviews as well as consumer information based on systematic reviews.
  • Executive summaries: executive or policymaker summaries of systematic reviews.
  • Clinical guides: clinician summaries of systematic reviews as well as clinical practice guidelines that are based on a fully reported systematic review.
  • Full text reviews: systematic reviews with full texts, including PDF versions.
  • Medical encyclopedia: medical and drug information for consumers for supplementary background information.

PubMed Health includes content that is currently also cited in PubMed, and PubMed Health will systematically be building in links to these citations. However, there will be some time lag for many items between inclusion in PubMed Health and citation in PubMed. Consumer content from PubMed Health is currently not included in PubMed.

Screen capture of Contents drop-down box.
Figure 2: Contents drop-down box.

At the top right-hand corner (see Figure 3), “About PubMed Health” explains the Web site and the National Center Biotechnology Information, NLM, with a full listing of content providers. “Help” includes explanation of basic functions, along with suggested citations for PubMed Health content.

Screen capture of About PubMed Health and Help features.
Figure 3: About PubMed Health and Help features.

Searching
The primary search (see #1 in Figure 4) returns clinical effectiveness content by relevance, with the option of viewing all (default) or only specified content types. Relevant medical encyclopedia results are shown at the right (see #2 inFigure 4), with the results of the “Clinical Queries” filter search for systematic reviews in PubMed showing below those (see #3 in Figure 4). “Clinical Queries” returns results chronologically.

Screen capture of Search results.
Figure 4: Search results.

Additional Features
With medical encyclopedia content, PubMed Health has enhanced the display of anatomical images and given this popular feature a more prominent position. There are links from the medical encyclopedia diseases and conditions pages to MedlinePlus® content.

PubMed Health now features “Add this” sharing for e-mail and social media. Coming in the fall, PubMed Health will begin a Twitter feed, announcing new content providers and features, as well as featured content.

PubMed Health full address: http://www.ncbi.nlm.nih.gov/pubmedhealth/
Shortcut: http://www.pubmed.gov/health
Customer service contact: pmh-help@ncbi.nlm.nih.gov

By Hilda Bastian
National Center for Biotechnology Information

 


November 16, 2011 Posted by | Biomedical Research Resources, Educational Resources (Health Professionals), Educational Resources (High School/Early College(, Finding Aids/Directories, health care, Health Statistics, Librarian Resources, Professional Health Care Resources, Tutorials/Finding aids | , , , , , , , | Leave a comment

PubMed Health — A Growing Resource for Clinical Effectiveness Information

 

Logo for PubMed, a service of the National Lib...

Image via Wikipedia

From the November NLM Technical Bulletin article

PubMed Health — A Growing Resource for Clinical Effectiveness Information

PubMed® Health developed further as a resource for clinical effectiveness research with its August and September 2011 releases. Growing from around 200 items based on systematic reviews to over 5,000, PubMed Health has also begun a collection focused on helping people understand systematic reviews and their results. PubMed Health goals are: helping users find the evidence that could answer their questions about effects of health care and helping them understand what they find.

Making Systematic Reviews More Accessible
Systematic reviews that identify and interpret studies on the effects of health care form an essential research basis for informed decision-making. Systematic reviewing has been growing, especially with the advent of The Cochrane Collaboration and the increasing incorporation of this methodology in health technology assessment by public agencies and clinical practice guideline development.

Systematic reviews (including health technology assessments) are often lengthy and highly technical. Their evolution has been accompanied by a growth in knowledge translation activity. Along with traditional abstracts, various forms have been developed to help people use systematic reviews: executive and policymaker summaries, summaries or other forms for patients/consumers and summaries for clinicians.

However, these materials have been scattered widely on content providers’ Web sites without being collected centrally. Many of the systematic reviews undertaken by public health technology assessment agencies have also remained outside the National Library of Medicine® (NLM®) system. The PubMed Health initiative is gathering them together within a single searchable resource.

PubMed Health Content
PubMed Health contains systematic reviews and summaries of systematic reviews undertaken or updated in roughly the last ten years. The time limit is applied to publication date of around eight years, to allow for the time lag from the date of the evidence search. The cut-off currently is 2003.

New content incorporated in these releases include summaries from The Cochrane Collaboration and the National Health Service (NHS) National Institute for Health Research (NIHR) Health Technology Assessment Programme. There are also full text reviews from the U.S. Agency for Healthcare Research and Quality (AHRQ), the Drug Effectiveness Review Project (DERP) at Oregon Health & Science University (OHSU), England’s National Institute for Health and Clinical Excellence (NICE) guidelines program, and the Department of Veterans Affairs’ Evidence-based Synthesis Program. From NHS Choices comes “Behind the Headlines”, its educational service on the science behind the news. These new content providers join PubMed Health original consumer clinical effectiveness content for consumers content provided by AHRQ and the German Institute for Quality and Efficiency in Health Care (IQWiG).

The reviews and review summaries now in PubMed Health account for perhaps one-third of the good quality systematic reviews published by public agencies and journals worldwide. Most of the remainder can be found in PubMed “Clinical Queries” Systematic Reviews search which runs simultaneously with a PubMed Health search; those PubMed results are presented as links on the right-hand portion of the results page (see #3 in Figure 4).

Organization
The re-designed homepage (see Figure 1) includes four key sections:

  • Contents: a complete alphabetical listing of all titles, sorted by type of content.
  • Behind Headlines: the NHS guide to the science behind health stories in the news.
  • New & updated: content added in the last 60 days.
  • Featured reviews: high quality reviews on interesting topics are selected and featured here. “Previously featured reviews” are provided in an RSS feed to which people can subscribe.
  • Understanding clinical effectiveness: an explanation of clinical effectiveness research along with a section focusing on resources to help people understand systematic reviews and interpret the results.

Screen capture of PubMed Health homepage.
Figure 1: PubMed Health homepage.

A drop-down box under “Contents” (see Figure 2) shows the categories of information currently included in PubMed Health where these are available:

  • For consumers: includes consumer summaries of systematic reviews as well as consumer information based on systematic reviews.
  • Executive summaries: executive or policymaker summaries of systematic reviews.
  • Clinical guides: clinician summaries of systematic reviews as well as clinical practice guidelines that are based on a fully reported systematic review.
  • Full text reviews: systematic reviews with full texts, including PDF versions.
  • Medical encyclopedia: medical and drug information for consumers for supplementary background information.

PubMed Health includes content that is currently also cited in PubMed, and PubMed Health will systematically be building in links to these citations. However, there will be some time lag for many items between inclusion in PubMed Health and citation in PubMed. Consumer content from PubMed Health is currently not included in PubMed.

Screen capture of Contents drop-down box.
Figure 2: Contents drop-down box.

At the top right-hand corner (see Figure 3), “About PubMed Health” explains the Web site and the National Center Biotechnology Information, NLM, with a full listing of content providers. “Help” includes explanation of basic functions, along with suggested citations for PubMed Health content.

Screen capture of About PubMed Health and Help features.
Figure 3: About PubMed Health and Help features.

Searching
The primary search (see #1 in Figure 4) returns clinical effectiveness content by relevance, with the option of viewing all (default) or only specified content types. Relevant medical encyclopedia results are shown at the right (see #2 inFigure 4), with the results of the “Clinical Queries” filter search for systematic reviews in PubMed showing below those (see #3 in Figure 4). “Clinical Queries” returns results chronologically.

Screen capture of Search results.
Figure 4: Search results.

Additional Features
With medical encyclopedia content, PubMed Health has enhanced the display of anatomical images and given this popular feature a more prominent position. There are links from the medical encyclopedia diseases and conditions pages to MedlinePlus® content.

PubMed Health now features “Add this” sharing for e-mail and social media. Coming in the fall, PubMed Health will begin a Twitter feed, announcing new content providers and features, as well as featured content.

PubMed Health full address: http://www.ncbi.nlm.nih.gov/pubmedhealth/
Shortcut: http://www.pubmed.gov/health
Customer service contact: pmh-help@ncbi.nlm.nih.gov

By Hilda Bastian
National Center for Biotechnology Information

 

November 16, 2011 Posted by | Biomedical Research Resources, Educational Resources (Health Professionals), Librarian Resources, Tutorials/Finding aids | , , , , , | 1 Comment

   

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