Tag: access to information

Bioethics Blogs

Access to Physicians’ Prescription Habits

Jean-Christophe Bélisle-Pipon calls attention to issues of accessibility and transparency related to the collection and sale of physician prescribing data by data solution companies.

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QuintilesIMS is a data solution company that provides services to the pharmaceutical industry. In 2002, the company was authorized by the Commission d’accès à l’information du Québec to receive and make use of personal information held by Québec pharmacies about physician prescribing practices, provided that: 1) specific professional acts were not linked to specific professionals; 2) physicians could refuse to have their information used; and 3) use of the information was restricted to reaching out, informing and training physicians. Data related to physician prescribing practices is sold by Québec pharmacies to QuintilesIMS. In turn, QuintilesIMS collects, collates this data and sells it to pharmaceutical companies for marketing purposes.

Recently, information related to QuintilesIMS business practices were leaked to the media.

Allegations have been made suggesting that data detailing the prescribing practices of 7,000 Québec physicians (including identifying information) have been disclosed to pharmaceutical companies. If proven true, this would represent an unauthorized practice, that contravenes the Act respecting the protection of personal information in the private sector. The issue at stake in the allegations is not the disclosure to companies, but rather, the disclosure of identifying information.

Physician prescribing data must be clustered in groups of 30 that have similar prescribing profiles. Thus, it is impossible in Canada (contrary to the US) to have access to individual physician prescribing profiles. In Québec, physicians can opt out of this data collection, and those who allow their information to be used, freely have access to their own prescribing profile.

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

User Beware: Privacy Settings just a Facade

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By Brenda Curtis, Ph.D.

Social media platforms continue to improve and refine their privacy settings as the demand for advanced user protections increases. Although enabling catered privacy settings to online profiles allows users to indicate who they would like share personal information with, it does not necessarily protect them from the platforms – i.e. websites and apps – themselves. Since social media accounts provide users with a sense of control over personal data, users assume that their information is safe. However, no matter what settings or privacy protections are applied to personal profiles, users do not generally have control over the online platform itself. What this means is the website or app being used usually shares information from accounts with third parties like advertising agencies or other databases. This data sharing is widespread throughout the industry, but it is not generally known by the public. This is partly because the disclosure of this sharing is done in the social media platform’s “Terms and Conditions” Which are often skimmed over or ignored.

Aside from social media websites, there are several other websites and apps that access your personal information via this information sharing to create a single database for everyone in the country. This is generally called data aggregation. One such site that has been in the news recently is FamilyTreeNow.  FamilyTreeNow is explicitly a genealogy site, and compiles information from various legal online sources to create a database full of personal information for genealogical research. This site pairs information from public records such as police records and court documents with the information collected from social media and address databases to create a sometimes way too revealing profile.

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

Costs, Schmosts!

Talk to your doctor about your out-of-pocket expenses. Ask about the cost of your meds. And await for the sound of silence! Sadly, that is too often what happens in medical clinics today. Here is a nice essay, exploring the topic, from a healthcare reporter.

With access to information about the costs of care, patients can make better choices about treatment paths that are aligned with their financial goals. Absent that information—or conversations with their physicians about costs—it’s virtually impossible for patients to incorporate this information into their decision-making.

Herein lies the problem: When physicians don’t talk to their patients about the cost of the care they receive, patients who are blindsided by medical bills may stop showing up for appointments, stop taking medications, and/or decide against pursuing their recommended treatment plans, which reduces the cost of care in the short term but can result in higher costs—for payers, providers, and patients—in the long term.

“We as physicians are trained to try to help patients weigh pros and cons [associated with treatment paths], but we don’t do that well when it comes to costs,” says Peter Ubel, MD, professor of business administration and medicine at Duke University. “Take an ultrasound, for example. A lot of [physicians] think, ‘What’s the downside? It’s a non-invasive test. I’ll just [order an ultrasound] and check the results.’”

What physicians often forget is that the cost of that ultrasound—which could be as much as $500—can “invade our patients’ wallets,” he says.

To read the rest of this article, please visit the Modern Medicine Network.

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

Crossing the Line: When Doctors’ Beliefs Endanger Patients’ Autonomy and Health

by Craig M. Klugman, Ph.D.

In 2016 the Illinois legislature passed and Governor Bruce Rauner signed into law Public Act 099-690 (SB 1564), an amendment to the Health Care Right of Conscience Act. This change states “It is also the public policy of the State of Illinois to ensure that patients receive timely access to information and medically appropriate care.” The change requires physicians to inform patients about legal treatment options including their factual risks and benefits, but does not require the physician to perform such services. If the hospital or physician has a conscientious objection to performing a procedure, then the patient must be referred to or transferred to someone or some facility that will.

For this effort, state officers have been sued in both state and federal courts by the Alliance Defending Freedom on behalf of a group of “pregnancy centers,” a doctor and her medical practice in Rockford, IL. Their complaint is that this law “forces them to promote abortion regardless of their ethical of moral views.” In other words, because the law requires doctors to allow patients to know all of their legal options indicated under standard of care and to be transferred elsewhere for services a physician or facility will not perform, this violates their religious freedom. The plaintiffs want it to be legal to lie, obfuscate, and keep information from patients and to keep patients away from legal and safe, medically indicated procedures. Specifically, this suit cites abortion.

Most surprisingly, a judge in a rural county has issued an injunction against the law going into effect (only) for the named plaintiffs.

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

Web Roundup: Moving forward in the face of uncertainty and debatable facts by Jane Roberts

And so ends 2016 – a year many have regarded as pretty topsy-turvy and trying at times. The focus of this month’s web roundup relates to how we operate when faced with uncertainty. The last twelve months have certainly shed light on how it is within our nature to crave and create structure and meaning for ourselves, and what happens when we are confronted with disruptions to our sense of what is fact, what is a result of our own belief systems, and where the two intersect.

One fact that we can all agree on is that we now live in a time of unprecedented access to information, with seemingly limitless ways to find out what we want to hear, precisely when we want to hear it. This article addresses the question of why so many are afraid of so much, with the authors suggesting that fears themselves create a new risk for our health and well-being that need to be addressed. Perhaps when it comes to anxiety in relation to the unknown, it is sometimes better for us to be pessimistic from the start rather than suddenly thrown into the realm of uncertainty. The illusion of hope is more anxiety-inducing that the certainty of failure, and sometimes we are more adversely affected by not knowing if a result is going to be positive or negative than we are by expecting a negative result, as suggested here. Misperceiving certain risks may actually be more significant, and hazardous, than any one individual risk, however this is very much culturally based.

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

Final Rule: HHS and NIH’s New Information Requirements for Clinical Trials: Is More Information Beneficial and For Whom?

By Jorge Luis Rivera-Agosto

On September 16, 2016, the U.S. Department of Health and Human Services (HHS) presented a final rule, in conjunction with a complementary policy of the National Institutes of Health (NIH), amending Tile 42, Chapter 1 of the Code of Federal Regulations[1]. This final rule will bring about a new era for the different stakeholders in the health care industry: patients, providers, researchers and our government[2]. It represents a big step toward increased access to information about certain clinical trials, a topic that affects subjects’ informed consent directly. The regulation’s aim is to specify “how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to ClinicalTrials.gov”. As such, it does not create new requirements on data, design, or conduct of clinical trials[3].

All stakeholders in the field of research ethics have engaged in continuous debate regarding the need for “increased access to information about clinical trials”[4]. The lack of publications[5] (researchers that don’t publish their findings for a variety of reasons such as that their data won’t be of benefit to the whole community) of clinical trials and biased literature[6],[7] (when researchers publish positive rather than negative findings) concerning clinical trials outcomes are major concerns. The problems previously mentioned are what this regulation tackles.

First, Section 11.22 of the final rule explains which clinical trials must be registered in the webpage. It states that all clinical trials initiated after September 27, 2007, or any clinical trial initiated before or continued after such date, must figure in ClinicalTrials.gov

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

Clinical Trials: Sharing of Data and Living Up to Our End of the Bargain

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Today we took a huge step forward in our efforts to make sure that data from biomedical research is shared widely and rapidly. The NIH, in collaboration with our fine colleagues at the U.S. Food and Drug Administration (FDA), and with the valuable input from scientists, patients and other members of the public, has announced the HHS regulation and NIH policy to ensure that information about clinical trials is widely shared. In this blog I want to talk about what this will mean for patients, providers, and researchers. I also want to reflect a bit on how the new regulation and policy fit into our overall efforts to improve clinical trials and data sharing.

Clinical trials are essential for the translation of research advances to new approaches to prevention and treatment. Volunteers who take part in clinical trials often do so with no assurance of personal benefit, but with the expectation that their involvement will add to the growing body of knowledge about health and disease, and thus may help others someday. For that to be realized, all trial results information needs to be publicly reported in a timely fashion—and yet we know that doesn’t always happen. Today’s announcements aim to change that. The HHS regulation issued today, called a “final rule”, describes requirements for registering certain clinical trials and submitting summary results information from these trials to ClinicalTrials.gov, a database managed by NIH’s National Library of Medicine (NLM).

The rule implements the statutory requirements established by Congress for ClinicalTrials.gov to serve as a public source for information about clinical trials.

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

New Food Labeling Law

         ‘Victory wrapped inside a defeat’ ?

 

By Claire Davis

 

In his recent op-ed “G.M.O. Labeling Law Could Stir a Revolution,” published in The New York Times, Mark Bittman criticized the new amendment to the Agricultural Marketing Act of 1946 as “the weakest labeling law imaginable,” but went on to highlight a potential upside. Calling it a “victory wrapped inside a defeat,” he argued that increased access to information about genetically modified organisms (GMOs) in food products will spur consumer interest in other aspects of food production.

 

Mr. Bittman named a variety of potential areas of interest, from the most rudimentary questions of where the ingredients in a food product were produced to more detailed ones, such as what pesticides remain on a food product, how much water is used to produce a crop, and whether farm laborers have health insurance. In Mr. Bittman’s vision, this “transparency revolution” will be a joint undertaking of consumers and industry producers, with consumers leading the call for change and companies providing detailed information directly on their packaging.

 

At Johns Hopkins University, we are developing a comprehensive labeling system to provide consumers with information about the ethical value of their food products. As part of the Global Food Ethics and Policy Program, the project, titled Consumers, Certifications and Labels: Ethically Benchmarking Food Systems, brings together scholars and experts from the Bloomberg School of Public Health and the Berman Institute of Bioethics as well as several other participants from the US and Europe.

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

Kids with Trisomy 13 and 18 can have good quality of life

Former Senator Rick Santorum with daughter Bella in 2012   

Should babies with Trisomy 13 and Trisomy 18 be given life-sustaining treatment? Both conditions are associated with severe physical and intellectual disabilities and most die children in their first year. So until recently, few of them were treated. Doctors regarded the conditions as “lethal congenital anomalies”.

However, according to a surprising study in JAMA, the Journal of the American Medical Association, it turns out that the consensus was wrong. Bioethicist John Lantos, a former President of the American Society of Bioethics and Humanities, commenting on an article about the survival rates, says:

In the age of social media, however, everything changed. Parents share stories and videos, showing their happy 4- and 5-year-old children with these conditions. Survival, it turns out, is not as rare as once thought. Children who were not institutionalized looked happy, cared for, and loved. It became increasingly awkward to describe these conditions as incompatible with life to parents who had ready access to information showing that it was not true.

One of these babies was Bella, the child of Senator Rick Santorum, a former presidential hopeful. He and his wife were told ““You realize that your child is going to die. You have to learn to let go.” The Santorums did not follow the doctors’ advice; their daughter is now 8 years old and in a stable medical condition.

This story illustrates how predictions of lethality become self-fulfilling prophecies [writes Lantos]. If Bella had not received supplemental oxygen or cardiopulmonary resuscitation, predictions that she would die early in life would have turned out to be true.

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

Thumbs Up for Privacy

“Hey, Iain,” says Fran, a Manchester alumna, “What do you make of this?”  I won’t bother rehearsing the whole scenario described in the post, but the dilemma it describes – set out by one Simon Carley – is fairly easily summarised: you work in A&E; a patient is rolled in who’s unconscious; there’s no ID, no medic alert bracelet – in short, nothing to show who the patient is or what their medical history is; but the patient does have an iPhone that uses thumbprints as a security feature.  And it might be that there’s important information that’d be accessible by using the unconscious patient’s thumb to get at it – even if it’s only a family member who might be able to shed some light on the patient’s medical history.

It’s a potentially life-or-death call.  Would it be permissible to hold the phone to the patient’s thumb?

For those who think that privacy is a side-constraint – that is, a moral consideration that should not be violated – the answer will be obvious, and they’ll probably stop reading around about… NOW.  After all, if you’re committed to that kind of view, it’s entirely possible that the question itself won’t make a great deal of sense (tantamount to “Is it OK to do this thing that is plainly not OK?”), or at least not be worth asking.  But I don’t think that privacy is a side-constraint; I’m increasingly of the opinion that privacy is a bit of an iffy concept across the board, for reasons that needn’t detain us here, but that might be implied by at least some of what follows.

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.