Tag: patient advocacy

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

The Deadly Business of an Unregulated Global Stem Cell Market

Guest Post: The deadly business of an unregulated global stem cell industry

Tereza Hendl and Tamra Lysaght

In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.

The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.

This case came to our attention as part of the work being done on an Australian Research Council funded Linkage Project “Regulating autologous stem cell therapies in Australia.”

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

Public Members Needed

The Research Involving Human Subjects Committee (RIHSC) FDA’s IRB, is looking for up to three individuals from the community to serve as public members on the committee.

 

FDA is committed to safeguarding the rights and welfare of all human beings who participate as subjects in research. The RIHSC reviews all research involving human subjects conducted, supported, or funded, in whole or in part, by FDA, to ensure that the research complies with applicable laws and ethical research standards.

 

What kind of members serve on an IRB?

 

Ideally, IRBs are made up of members from diverse backgrounds.  Diversity assures a complete and thorough review of the research activities from a variety of perspectives.

 

We are seeking community members with different kinds of backgrounds than our current members. Some examples would be educators, members of the clergy, laborers, and previous government employees who have not worked in public health agencies.

 

RIHSC membership currently has scientists, health care professionals, social scientists, and regulatory counsel.

 

What are the qualifications RIHSC is seeking in a Public Member?

 

Although not required, it may be beneficial to have experience in:

 

  • Health communication, health literacy, or plain language
  • Consumer or patient advocacy
  • Ethical analysis or

 

Community members who volunteer to be a public member for RIHSC may not be affiliated with FDA or be an immediate family member of a person affiliated with FDA. 

 

What are the responsibilities of a public member of RIHSC?

 

The public members on a rotating basis will be asked to:

 

  • Prepare for monthly committee meetings
  • Attend monthly committee meetings (typically meets for 2-3 hours on the first Wednesday of the month, during business hours)
  • Attend meetings
  • Add to the discussion and vote on the proposed study based on certain criteria, such as if the risk to subjects is reasonable, minimized, and fully disclosed to subjects.

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

Patient advocates often in cahoots with industry

Over the past few decades, hundreds of patient-advocacy organizations have emerged in the United States, promoting disease research and influencing legislation and FDA and health insurer policies. A new study has revealed that a large proportion of these organizations have funding or other connections with drug or medical device makers, but do not adequately disclose these connections.

The study, led by medical ethicists at the Perelman School of Medicine at the University of Pennsylvania and published in the New England Journal of Medicine, suggests that patient advocacy organizations should acknowledge industry connections.

Media reports have highlighted the fact that some industry-funded patient-advocacy organizations support the industry line on policy issues, for example by failing to support drug-price reform measures, and by pushing insurers to cover expensive drugs whose benefits to patients are questionable.

In the new study, the team examined websites and annual reports for 104 US-based patient-advocacy organizations with annual revenues of US$7.5 million or more.

Results showed that the vast majority received industry funding. More than 80% explicitly reported it, and most of the rest left open the possibility by providing no donor information. Only one of the 104 stated plainly that it did not accept industry funding.

Information on donations was typically provided in broad ranges, and in some cases not disclosed at all. But, among the 59 organizations that published donated amounts, 23 reported receiving at least $1 million annually.

The study revealed other connections to industry besides financial support. More than one-third of the reviewed organizations had one or more board members who were also company executives.

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

Patient Advocacy Groups Have Close Ties with Industry, But Some Lack Transparency

March 1, 2017

(STAT News) – Patient advocacy organizations carry out important work like funding research and lobbying on behalf of people with a certain health condition — but they also can be less than fully transparent, with some failing to publicly list their sources of funding, a new study finds. Why it matters: While drug and device companies are required by federal law to disclose all payments they make to doctors and teaching hospitals, they don’t need to tell anyone how much money they give to patient advocacy 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

Rebecca Dresser on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! This week features Professor Rebecca Dresser of Washington University. She is the author of Silent Partners: Human Subjects and Research Ethics (Oxford University Press, 2016) and When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford University Press, 2001), along with many … Continue reading

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

Conflicts of Interest in unsuspected places

Patient advocacy organizations — groups such as the American Cancer Society, the American Diabetes Association, the Arthritis Foundation — are non-profit organizations that seek to help patients with a specific disease or disorder by providing services to patients, sponsoring research, influencing government and insurance policy, and promoting and promulgating guidelines that are followed by doctors and patients to diagnose and treat disease. They are sometimes… // 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.

Bioethics News

Behind Patient Advocacy Groups, Donors Are Exerting a Powerful Force, Study Says

January 17, 2017

(STAT News) – At a time when drug company lobbyists are widely vilified as icons of avarice, patient advocacy groups still wear the white hats. But those organizations, which promote cures for every type of cancer and hundreds more diseases, have come under criticism lately for favoring their drug company funders in contests on Capitol Hill. In one case, a diabetes group accepted money from food companies and played down the health risks from their high-sugar products; in another case, a mental health association, reliant on drug company dollars, opted to keep quiet about the soaring prices of its antidepressants. And many of the patient advocacy groups pushing for passage of the 21st Century Cures Act, which consumer groups argue rolls back patient protection, are funded in large part by pharmaceutical firms.

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

Pharma Money Reaches Guidelines Writers, Patient Groups, Even Doctors on Twitter

January 17, 2017

(Pro Publica) – The long arm of the pharmaceutical industry continues to pervade practically every area of medicine, reaching those who write guidelines that shape doctors’ practices, patient advocacy organizations, letter writers to the Centers for Disease Control and Prevention, and even oncologists on Twitter, according to a series of papers on money and influence published today in JAMA Internal Medicine.

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

Conference Report: “Biopolitics and Psychosomatics: Participating Bodies” by Alev Sen

Biopolitics and Psychosomatics: Participating Bodies

8 July 2016, University of Cambridge

Conveners:
Darin Weinberg, University of Cambridge
Monica Greco, Goldsmiths, University of London
Robbie Duschinsky, University of Cambridge
Michael Schillmeier, University of Exeter

Introduction

Can we think of our living bodies as involving forms of social intelligence, agency, and power? And if so, how might this proposition transform the ways in which we consider the possibilities and politics of patient participation? These were the questions at the core of the intellectual agenda of the conference “Biopolitics and Psychosomatics: Participating Bodies”, held on 8 July 2016 at the Centre for Research in the Arts, Social Sciences and Humanities (CRASSH) at the University of Cambridge. The event—co-convened by Monica Greco (Goldsmiths), Darin Weinberg and Robbie Duschinsky (University of Cambridge) and Michael Schillmeier (University of Exeter)—aimed to reclaim the term ‘psychosomatic’ from the reductive and polemical forms of engagement in which it is often caught, and use it as a springboard for reframing questions of agency, embodiment, responsibility, power and choice in the context of current challenges facing state-sponsored service provision in Europe and the US.[1] The spirit of the conference was explicitly exploratory, more concerned with creating space for a new type of conversation than to provide direct answers to the many questions raised. Despite a last-minute cancellation by Laurence Kirmayer, who was scheduled to deliver the closing keynote, the conference proved successful, stimulating discussion and debate about these important and timely questions, on practical, political and intellectual levels.

After Darin Weinberg’s welcome address Monica Greco’s introduction outlined the multiple connotations of the term ‘psychosomatic’ and the striking contrast between them.

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.