Tag: conflict of interest

Bioethics Blogs

Webinar Follow-up: Data and Safety Monitoring: Advanced Issues and Case Studies

In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest.

The post Webinar Follow-up: Data and Safety Monitoring: Advanced Issues and Case Studies appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Right to Try: Why Logic and Facts Won’t Win This One

by Craig Klugman, Ph.D.

Last week the U.S. Senate passed bill S. 204, the Trickett Wendler Right to Try Act of 2017. Trickett Wendler was a woman with ALS. The ALS association and her family lobbied Congress to support this bill to give all patients living with a terminal illness the “right” to purchase experimental drugs from pharmaceutical companies. Essentially, this bypasses the FDA’s compassionate use program. Instead of filing an application for FDA compassionate use (which the FDA approves 99% of the time), the patient asks the drug manufacturer directly. As I have written in this space before, such laws threaten public health efforts through the FDA to ensure safe and efficacious pharmaceuticals.

Currently, 37 states have such right-to-try laws and more have considered them. The push for these laws begins with the Barry Goldwater Institute, a libertarian think-tank, funded in part by the Koch brothers. Last month I had the surreal experience of debating two right-to-try supporters (one from a business school and one from the Goldwater Institute) about these laws which they base in a “right to self-medicate.” There were two of us against self-medication and two in favor of it.  You can read the commentaries and responses of the debaters here.

In this essay, I do not plan to restate my arguments against right-to-try. You can read my thoughts on this policy here and here. Instead, this post will examine the tools of argumentation that my opponents employed in the debate. It is important to show their debate techniques so that we all have a better understanding of how to analyze claims to support right-to-try and to realize why better facts and better arguments are falling on deaf ears.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

UK government appointed  ‘guardian’, for speak for Charlie Gard in Court, euthanasia activist

Charlie Gard’s parents angry that baby’s lawyer is head of charity that backs assisted dying 

Charlie Gard’s parents have privately expressed their concern after discovering that the lawyer appointed to represent their 11-month-old son in court heads a charity that backs assisted dying.

Victoria Butler-Cole, who speaks on Charlie’s behalf in court, is chairman of Compassion in Dying, a sister organisation to Dignity in Dying which campaigns for a change in the law to make assisted dying legal in the UK. Dignity in Dying used to be called the Voluntary Euthanasia Society.

Connie Yates and Chris Gard, from Bedfont, in west London, believe they, as his parents, should speak for Charlie in court hearings that are deciding his fate. They don’t believe their son should have a guardian representing him in court.

Charlie Gard’s lawyer backs assisted dying. Is there a conflict of interest?

As we already know, Great Ormond Street Hospital is seeking to switch off his life support machine and has been backed in court by Charlie’s state-appointed guardian, represented by Mrs. Butler-Cole.

A source close to the parents told The Daily Telegraph: “The family finds it astonishing that the lawyer that appointed the barrister to act in the interests of Charlie Gard is the chairman of Compassion in Dying, the sister body of Dignity in Dying, formerly known as the Voluntary Euthanasia Society. The implication is obvious. It looks like a profound conflict of interest.” (The Telegraph, 7 – 18 – 2017).

See our Charlies Grant’s Special Report, a medical and ethical assessment.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

My Sister’s Keeper: An Assessment of Living Organ Donation among Minors

by Alex Fleming

The 2009 film My Sister’s Keeper, based on Jodi Picoult’s 2004 New York Times bestselling novel which bears the same name, is among other things, a controversial story about a young girl (Anna Fitzgerald) who sues her own parents in order to obtain legal rights to the use of her body. For as long as she can remember, Anna has unwillingly been providing blood and bone marrow to her older and critically ill sister, Kate. As the story unfolds, tension within the family arises as the 13 year-old Anna Fitzgerald becomes fully aware of her reason for existence, so to speak, which is to prevent the death of her older sister by providing a regular supply of blood and bone marrow, which she has done regularly for several years. Later on, as Kate’s condition worsens and her renal function begins to fail, the parents naturally turn to Anna to provide what could be a life-saving kidney transplant for her older sister. The climax of the story begins as Anna confidently and heroically refuses. The story raises a slew of bioethical issues which are beyond the scope of this essay; however, the story sheds light on a topic worthy of discussion: living organ donation among minors.

As the supply of organs suitable for transplantation decreases and the demand for them increases, the question of living organ donation among those yet of age has become a question of greater concern, primarily among those who point to the various ethical implications which such a procedure creates.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

FDA Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Objective Intent and Notice & Comment.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when the FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

Advisory committees play an important role at FDA, including for new drug approvals.  Often when FDA is considering whether to approve a new drug, it will ask an advisory committee—a group of outside experts—to provide the agency with advice on various scientific questions about the drug.  At a typical drug-related advisory committee meeting, the drug company and FDA will each take a turn presenting the scientific evidence about the unapproved drug, then there will be an open public hearing at which any interested member of the public may speak, followed by the advisory committee’s discussion of, and vote on, the questions that FDA has posed to it. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Undermining the USPSTF: The most important stakeholders are the patients

A strange “health care” drama plays out daily in our clinics and hospitals. A healthy person has a medical test done (even though he or she is healthy): a blood test, a chest x-ray or mammogram, maybe an ultrasound of some body part. The test comes back abnormal. The patient (for she has now gone from being a healthy person to being a patient) is struck with worry, and undergoes a further round of testing to determine whether the initial, “screening” test was accurate. This more invasive, risky definitive testing causes the patient pain, complications, infections, further procedures to fix the complications. But the testing shows that the original screening test was wrong, and the patient is relieved of their worry and overcome with a sense of gratitude: “Yes, the follow-up surgery was painful, but at least it’s not cancer.” However, notice what caused the worry in the first place: not some symptom that they were experiencing, but a test that was performed on a healthy person. What a marvelous bit of sorcery: we take a happy patient, create unnecessary worry, then win their undying gratitude by performing risk-laden procedures on them to remove their worry!

There is something very intuitive about the concept that detecting a disease (especially cancer) early leads to better outcomes, that screening tests are inherently good. Yet when one studies the actual outcomes of implementing mass screening programs in a population of people who have no signs or symptoms of a particular disease, one finds to one’s surprise that, not infrequently, more people are harmed by our screening test than are helped (See: PSA testing, carotid ultrasounds, annual stress tests, etc).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

BioethicsTV: Boundary Crossings, Savior Children, and Euthanasia

by Craig Klugman, Ph.D.

In last week’s episode of Chicago Med (Season 2, Episode 21), Dr. Charles cannot separate his personal and professional roles. When his daughter (an epidemiologist in the hospital) is being evaluated by his resident, Dr. Charles is concerned that no one can evaluate his daughter as well as he can. Rather than trusting his resident and the system, he interferes at every step. First, he arranges to have his resident (rather than someone else’s) evaluate his daughter. Second, he logs onto the electronic medical record to look at the notes on his daughter’s case. Third, he consistently asks his resident questions about the case. Fourth, he steals his daughter’s keys and visits her home where he finds strong evidence of her psychological disorder. Fifth, he arranges an involuntary commitment for his daughter and watches as the guards catch her and take her to the inpatient psychiatric ward.

There are two major problems in this storyline. Consider first that Dr. Charles not only tries to diagnose but actually prescribes treatment (in the form of involuntary commitment) for his daughter. There is a reason that physicians are not supposed to treat their patients including loss of objectivity and clinical gaze. The results are seen in this episode when we learn that the resident was giving Dr. Charles (the daughter) the night to consider whether she wanted to voluntarily commit herself. By usurping the plan of his resident, Dr. Charles (senior) destroys trust between the patient and his resident; between himself and his daughter; and between himself and his resident.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Disclosure, Doctors and Social Media

As doctors and health professionals take to public spaces like Twitter and Facebook to curate and create we face new challenges. One of the challenges is how to disclose our relationship to the organizations and products. How do we disclose conflict of interest in so many different kinds of venues?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Expert Advisory Committees & Conflict of Interest

Jean-Christophe Bélisle-Pipon, Louise Ringuette, and Bryn Williams-Jones describe a five-step approach for managing conflicts of interest in public health decision-making.

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On a regular basis, shocking news filters into the media about conflicts of interest within public organizations that contribute to policy-making. When such allegations are proven true, public scepticism about whether public interests or commercial interests inform policy-making increases.

Public health decision-making, especially in areas of complex science, is generally supported by expert advice. One such area is publicly-funded immunization. In Canada, the National Advisory Committee on Immunization is an advisory body to the Public Health Agency of Canada, while the provinces and territories rely on advice from local expert advisory committees.

Members of immunization expert advisory committees have an important role to play in guiding public health decision-making, particularly with regard to the selection of vaccines and the scheduling of immunizations. Given this important role, independence and transparency are expected. One mechanism for promoting independence is a robust, publicly available conflict of interest policy.

We suggest a simple five-step approach for better managing conflicts of interest.

First, ask the right questions and identify red flags. What are the interests at stake and for whom?

For example, consider situations where one or more committee members receive(s) significant funding from industry. Are there external interests, as a result of this funding, that may influence the committee’s mandate and activities? This concern applies to private companies with products or business activities related to immunization, or with connections to certain advocacy or interest groups.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

A Conflict of Interest is NOT an Ambiguity

Oregon Senate Bill 494 has been described as a “euthanasia bill” that is “intentionally ambiguous,” and as a piece of legislation that would “allow the starving and dehydrating of patients who suffer from dementia or mental illness.” What has received less press is the composition of the 13-member committee who would be perpetually in charge of advance directive forms in the state, with no oversight by… // Read More »

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.