Health and Medical News and Resources

General interest items edited by Janice Flahiff

Should scientists be allowed to genetically alter human embryos?

From the 1 July 2015 EurekAlert

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Scientists have at their disposal a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure rife with controversy. An article in Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society, parses the explosive issue.

Britt E. Erickson, a senior editor at C&EN, reports that at least one team of scientists has already published a study on altering disease-related genes of human embryos. The experiment was largely unsuccessful, but it stoked fears that such research on embryos could lead to potentially dangerous or unethical applications. Would parents start demanding designer babies engineered to be smarter or more attractive? What would be the long-term consequences of changing people’s genes before they’re born?

Without answers yet to these critical questions and others, many European countries have banned gene editing of human reproductive cells. In the U.S. — where federal dollars cannot go toward this type of work — and in China, scientists are allowed to pursue this type of research. But the landscape is likely going to change as scientists, ethicists and lawmakers hash out a path forward.

July 17, 2015 Posted by | Medical and Health Research News | , , , , , , , , | Leave a comment

Ethics: A Patient’s Right to Not Know

Ethics: A Patient’s Right to Not Know.

Excerpt

Writing in Science, the chair of the Presidential Commission for the Study of Bioethical Issues notes it is increasingly common for physicians and medical researchers to discover a disease that was not the original target of a medical test or screening.

Amy Guttman Ph.D. notes these surprise clinical test results are called incidental and secondary findings. Guttman explains the surprise discovery of an unexpected illness from screening and similar tests is called an ‘incidental’ finding. Guttman adds when clinicians deliberately seek to discover a second or third disease in addition to the primary target, these results are called ‘secondary’ findings.

Guttman, who is the president of the University of Pennsylvania, writes (and we quote): ‘Improved technologies are making incidental and secondary findings increasingly common. They are becoming a growing certainty in clinical practice as well as in the distinct contexts of research and direct-to-consumer testing’ (end of quote). For example, Guttman notes an array of unexpected clinical findings may be generated by new CT scans intended to detect lung cancer in heavy smokers. The increased screening will occur because of recent recommendations from the U.S. Preventive Services Task Force, which we discussed in last week’s podcast.

Guttman writes before CT scans or other medical tests, clinicians should alert patients about the possibility of surprise findings regardless whether screening deliberately seeks (or accidentally finds) new, unexpected illnesses.

Guttman notes while some persons will ask a physician to tell them about whatever clinical tests discover, some patients do not want to learn about incidental or secondary findings.

As a result, the Presidential Bioethics Commission recommends physicians and medical practitioners need to know a patient’s health priorities and tolerance to manage surprising results prior to clinical testing. Guttman writes (and we quote) ‘A patient who does not wish to learn about information related to the primary purpose of the test should not undergo the test. If a patient wishes to opt out of receiving incidental or secondary findings that are clinically significant and actionable, then clinicians should exercise their discretion whether to proceed with testing’ (end of quote).

Guttman notes health care providers should explain both the risks and rewards of finding unexpected illnesses that can occur from a new generation of sophisticated clinical tests, such as human genome screenings. While false positive findings are among the risks, Guttman explains the rewards include the detection of diseases and illness that could be clinically actionable.

In terms of biomedical ethics, Guttman concludes (and we quote):’ In keeping with shared decision-making, clinicians live up to their highest calling when they discuss how they will handle incidental findings with their patients’ (end of quote). While the Presidential Bioethics Commission provides more specific recommendations in their report, their overall intent is to improve patient-provider disclosure and communication as well as help patients anticipate the possibility of unexpected findings from routine testing.

The Commission’s report is available at bioethics.gov.

Meanwhile, a link to a website that explains some of the ethical issues associated with patient and provider health decision making (from Beth Israel Medical Center) is available in the ‘specific conditions’ section of MedlinePlus.gov’s medical ethics health topic page.

Similarly, a link to a website that explains some of the ethical issues associated with patient and provider treatment decisions (also from Beth Israel Medical Center) can be found in the ‘specific conditions’ section of MedlinePlus.gov’s medical ethics health topic page.

MedlinePlus.gov’s medical ethics health topic page also provides links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. You can sign up to receive updates about medical ethics as they become available on MedlinePlus.gov.

To find MedlinePlus.gov’s medical ethics health topic page type ‘medical ethics’ in the search box on MedlinePlus.gov’s home page. Then, click on ‘medical ethics (National Library of Medicine).’ MedlinePlus.gov additionally contains a health topic page on talking with your doctor, which provides tips to enhance provider and patient communication.

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March 26, 2014 Posted by | health care | , , , , , , , , , | Leave a comment

[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

Ethics Abandoned: Medical Professionalism and Detainee Abuse in the ‘War on Terror’

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From the summary at Full Text Reports (November 6, 2013)

Source: Institute on Medicine as a Profession and Open Society Institute (via Harvard Law School)

the task Force has determined that actions taken by the U.s. government immediately following 9/11 included three key elements affecting the role of health professionals in detention centers:

1. The declaration that as part of a “war on terror,” individuals captured and detained in Afghanistan, Pakistan, and elsewhere were “unlawful combatants” who did not qualify as prisoners of war under the geneva conventions. Additionally, the U.S. Department of Justice approved of interrogation methods recognized domestically and internationally as constituting torture or cruel, inhuman, or degrading treatment.

2. The DoD and CIA’s development of internal mechanisms to direct the participation of military and intelligence-agency physicians and psychologists in abusive interrogation and breaking of hunger strikes. Although the involvement of health professionals in human rights violations against detainees progressed differently in the military and the CIA, both facilitated that involvement in similar ways, including undermining health professionals’ allegiances to established principles of professional ethics and conduct through reinterpretation of those principles.
[my emphasis – Janice]

3. The secrecy surrounding detention policies that prevailed until 2004– 2005, when leaked documents began to reveal those policies. secrecy allowed the unlawful and unethical interrogation and mistreatment of detainees to proceed unfettered by established ethical principles and standards of conduct as well as societal, professional, and nongovernmental commentary and legal review.

These key elements, as well as the task Force’s recommendations for remediating the participation of health professionals in detainee torture or cruel, inhuman, or degrading treatment, are summarized below and addressed in detail in the body of this report.

November 7, 2013 Posted by | health care, Psychiatry | , , , , , , | 2 Comments

NLM Director’s Comments Transcript Force Feeding Guantanamo Detainees Criticized

The NLM Director showed some courage in commenting on the force feeding of prisoners in Guantanamo.
This is indeed a health issue, because we are indeed responsible for the health (including mental health) of these detainees.

Some excerpts from the comments, full text may be found here.

A candid and stimulating editorial, recently published in the New England Journal of Medicine, strongly suggests physicians at the Guantanamo Bay detainment camp in Cuba should not force feed detainees who are on a hunger strike. The editorial’s three authors argue the force feeding of some Guantanamo prisoners is medically unethical — and the practice warrants more criticism from health care professionals.

A news story about the editorial published in the U.K. Guardian reports the Guantanamo Bay camp currently houses about 166 prisoners (most of whom are held for alleged terrorist activities). Many of these detainees or prisoners have been held at Guantanamo Bay (a U.S. military base in Cuba) in an era that began with the destruction of the World Trade Center in New York City on September 11, 2001. At the time the editorial was published, the Guardian reported 104 prisoners were on a hunger strike and 43 detainees received forced feeding.

The editorial’s authors (who are highly respected senior faculty at Boston University’s Schools of Public Health and Medicine) write [and we quote]: ‘Guantanamo is not just going to fade away, and neither is the stain on medical ethics it represents’ (end of quote).

The editorial’s authors explain the ethical principle to not force feed prisoners initially was advanced by the World Medical Association’s Declaration of Helsinki after World War II. The authors cite the declaration that says (and we quote): ‘forcible feeding (of mentally competent hunger strikers) is never ethically acceptable’ (end of quote). The authors add forced feeding (and we quote): ‘is a form of inhumane and degrading treatment’ (end of quote).

The editorial’s authors note a U.S. Department of Defense’s 2006 directive on force feeding detainees says (and we quote): ‘In the case of a hunger strike, attempted suicide, or other attempted serious self-harm, medical treatment or intervention may be directed without the consent of the detainee to prevent death or serious harm’ (end of quote).

However, the authors explain a hunger strike is not an attempt to commit suicide. They discern the goal of the hunger strikers (and we quote): ‘is not to die but to have perceived injustices addressed’ (end of quote).

In addition, the authors suggest physicians abdicate their professional responsibilities to make individual and independent medical assessments when they participate in penological decisions that maintain prison order by force feeding detainees. The authors write (and we quote): ‘physicians who participate in this nonmedical practice become weapons for maintaining prison order’ (end of quote).

The editorial’s authors also imply a sense of frustration with the dearth of criticism among physicians regarding Guantanamo’s forced feeding efforts.

The authors conclude (and we quote): ‘As (Guantanamo) increasingly becomes a medical ethics-free zone, we believe it’s time for the medical profession to take constructive political action to try to heal the damage and ensure that civilian and military physicians follow the same medical ethics principles’ (end of quote).

We should add it is rare to see such a frank and critical editorial in one of the world’s leading medical journals. The editorial is a reminder of the field of medical ethics’ capacity to illuminate health and social issues.

Meanwhile, a helpful overview of the legal and ethical issues in health care (provided by Merck and Co. Inc) is provided in the ‘overviews’ section of MedlinePlus.gov’s medical ethics health topic page.

A link to information about the nutritional needs of end-of-life patients is available within the introduction of MedlinePlus.gov’s medical ethics health topic page. MedlinePlus.gov’s medical ethics health topic page also provides updated, comprehensive, evidence-based information about diverse healthcare ethics issues such as: genetic and prenatal testing, birth control, organ donation, and patient rights.

MedlinePlus.gov’s medical ethics health topic page additionally contains links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. From the medical ethics health topic page, you can sign up to receive email updates with links to new information as it becomes available on MedlinePlus.

To find MedlinePlus.gov’s medical ethics health topic page, just type ‘medical ethics’ in the search box at the top of MedlinePlus.gov’s home page. Then, click on ‘Medical ethics (National Library of Medicine).’ MedlinePlus.gov also has a health topic page devoted to nutrition and health.

 

July 22, 2013 Posted by | health care, Psychiatry, Psychology | , , , , , , , , | Leave a comment

Medical devices and shared decision-making

Medical devices and shared decision-making.

From the 18 October 2012 article at HealthNewsReview.org

The journal Arthritis Care & Research has accepted for future publication – and posted online (for subscribers) – an unedited paper, “Preceding the Procedure:  Medical Devices and Shared Decision-Making.”  The paper builds on a hypothetical example of a man in his 50s with hip arthritis who is facing a decision about total hip replacement.  Excerpts:

“(The surgeon – Dr. Jones) reviews the procedure with him and confirms that he understands his options. Then (the patient – Mr.Thomas) signs the surgical consent form. This discussion appears to include all the elements of informed consent, but several ethical questions linger beneath the surface. Dr. Jones discussed the risks and benefits of total hip replacement in some detail to help Mr. Thomas decide whether or not to have surgery, but should Mr. Thomas also have participated in the decision about the specific implant to be used?

This article teases out the ethical issues underlying the choice of a medical device for surgical procedures, using the example of total joint arthroplasty to illustrate the interactions between surgeons and their patients. We highlight shortcomings in the current regulatory process that result in a thin evidence base on which to anchor these technical decisions, and we note the potential for decisions to be influenced by the surgeon’s personal beliefs and possible conflicts of interest. We suggest that the informed consent process could be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values. …

 

urgeons reporting “that that they typically face few institutional constraints on their choice of implants, so many are able to decide for themselves when they wish to begin using newer models.”

Photo credit: dpstyles™ via Flickr

And it provides background for consideration of conflicts of interest:  “The choice of implant is complicated further by the possibility for conflicts of interest stemming from the consulting fees that some orthopedists receive from device manufacturers. In 2007, the five largest manufacturers made payments to approximately 4% of the 25,000 registeredorthopedic surgeons in the United States. These payments typically involve surgeons in high volume practices and academic settings. Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

 

October 29, 2012 Posted by | health care | , , , | Leave a comment

   

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