Tag: off-label use

Bioethics Blogs

Have I Been Cheating? Reflections of an Equestrian Academic

By Kelsey Drewry
Kelsey Drewry is a student in the Master of Arts in Bioethics program at the Emory University Center for Ethics where she works as a graduate assistant for the Healthcare Ethics Consortium. Her current research focuses on computational linguistic analysis of health narrative data, and the use of illness narrative for informing clinical practice of supportive care for patients with neurodegenerative disorders.

After reading a recent study in Frontiers in Public Health (Ohtani et al. 2017) I realized I might have unwittingly been taking part in cognitive enhancement throughout the vast majority of my life. I have been a dedicated equestrian for over twenty years, riding recreationally and professionally in several disciplines. A fairly conservative estimate suggests I’ve spent over 5000 hours in the saddle. However, new evidence from a multi-university study in Japan suggests that horseback riding improves certain cognitive abilities in children. Thus, it seems my primary hobby and passion may have unfairly advantaged me in my academic career. Troubled by the implication that I may have unknowingly spent much of my time violating the moral tenets upon which my intellectual work rests, I was compelled to investigate the issue.



The study in question, “Horseback Riding Improves the Ability to Cause the Appropriate Action (Go Reaction) and the Appropriate Self-control (No-Go Reaction) in Children,” (Ohtani et al. 2017) suggests that the vibrations associated with horses’ movement activate the sympathetic nervous system, leading to improved cognitive ability in children. Specifically, children 10 to 12 years old completed either simple arithmetic or behavioral (go/no-go) tests before and after two 10 minute sessions of horseback riding, walking, or resting.

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

Lupron: Déjà Vu All Over Again

Alice Dreger raises concerns about a pervasive pattern of non-evidence based assumptions driving practices in pediatric endocrinology.

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You’d think that the pediatric specialty that may have given cancer to women treated with estrogen because as girls they were ‘at risk’ of growing up tall might be pretty careful with other drugs. You’d think that it would be especially cautious about treating kids with hormone blockers because they are ‘at risk’ of growing up short.

Pediatric endocrinology, I’m talking to you.

Susan Cohen and Christine Cosgrove have done a fine job tracking the history of using estrogen to prevent tallness in girls, so I won’t review it here. But their work is inevitably brought to mind because of a report published last week in California Healthline by Christina Jewett.

Jewett relays mounting health concerns among women who were given the drug Lupron as girls to stop or slow down puberty. Some were treated as children specifically to try to get them to grow taller. Lupron may increase a child’s ultimate height by lengthening the span of years in which the long bones are growing.

Leuprolide

The U.S. Food and Drug Administration (FDA) has approved Lupron (leuprolide), a hormone-blocking agent, for the treatment of precocious puberty, endometriosis, and advanced prostate cancer. Last week, Denise Grady reported in the New York Times new oncology research which suggests it can prolong the lives of some men with prostate cancer.

But in all these uses, the drug is known sometimes to cause serious side effects. As one oncologist quoted in Grady’s article put it, the side effects are serious enough, “you’d better have some decent justification” to use 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

Interview with Dr. Marcia Angell, former Editor-in-Chief of the New England Journal of Medicine

by Mike Reaves

Dr. Marcia Angell is an American physician, author, and the first woman to serve as editor-in-chief of The New England Journal of Medicine. Dr. Angell joined the Journal’s staff in 1979, became executive Editor in 1988, and served as Editor-in-Chief of the journal until June of 2000. She is currently on the faculty of the Department of Global Health and Social Medicine at Harvard Medical School in Boston, Massachusetts. Her most popular work, The Truth About the Drug Companies: How They Deceive Us and What to Do About It (2004), is critical of big industry in healthcare and its role in research and medicine. In April of 2016, I had the opportunity to sit down with Dr. Angell for a discussion about some of the most controversial topics in healthcare economics, regulation, journalism, and politics.

I solicited Dr. Angell’s opinion on a recent decision regarding pharmaceutical companies, Amarin Pharma, Inc. v. United States. This decision holds that the First-Amendment protects off-label drug promotion by pharmaceutical companies. Dr. Angell indicated that it is difficult to prove that unethical behavior occurs in the promotion of off-label drugs because it is hard to monitor the behavior. She believes there will not be much success in the prosecution of individuals responsible for pushing these marketing strategies, and that jail time will likely be the only deterrent in an industry that incurs fines as a cost of doing business. 

I asked Dr. Angell about the Journal’s recent policy changes regarding conflict of interest. The current Editor of the Journal, Jeffery Drazen, has loosened the conflict of interest policy, which now allows authors of editorials and review articles to receive up to $10,000 from each drug company.

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

Consumer Neurotechnology: New Products, More Regulatory Complexity

By Anna Wexler


Anna Wexler is a PhD candidate in the HASTS (History, Anthropology, Science, Technology and Society) at MIT and a 2015-2016 visiting scholar at the Center for Neuroscience and Society at the University of Pennsylvania. Her dissertation focuses on the ethical, legal and social implications of emerging neuroscience technology, with a particular focus on the home use of noninvasive brain stimulation.

Just when it seemed like the consumer neurotechnology market couldn’t get any stranger—after all, who would’ve expected that a sleek white triangle could be placed on the forehead for “calm” or “energy” vibes—two new products recently hit the market that further complicate the challenges of regulating this emerging market. Halo Sport is a brain stimulator marketed for athletic enhancement that utilizes technology similar to transcranial direct current stimulation (tDCS), while Nervana, which began taking pre-orders in March, is the first noninvasive vagus nerve stimulation (VNS) device to be sold directly to the public in the United States.
Halo Neuroscience, the manufacturer of Halo Sport, advertises that its product “accelerates gains in strength, explosiveness, and dexterity.” In many ways, Halo Sport overcomes obstacles that have plagued other direct-to-consumer brain stimulation products. Because Halo Sport only claims to stimulate the motor cortex—which, conveniently for the company, lies beneath the area of the head where a pair of headphones might sit—the product does not utilize stray wires or a futuristic headset, but instead takes the recognizable shape of headphones. The beneficial effect of a familiar design should not be underestimated: many potentially useful technology tools have failed in no small part due to their unusual “look.”

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

Progress in favour of life. Oklahoma restricts abortion pills

The law restricted the options to abort.On 23rd February 2016, Oklahoma Supreme Court in the United States backed the validity of a law that established stricter regulations for the administration of abortion pills (abortion inducing drugs). In 2014, the Oklahoma Legislature passed law H.B. 2684 banning the use of Mifeprex (known as mifepristone or RU-486) and misoprostol to induce abortions. The law requires that Mifeprex be administered following a protocol approved by the Food and Drug Administration (FDA). The ruling of the Court in the case “Oklahoma Coalition for Reproductive Justice v. Cline” revoked the decision of the lower court that had considered the law as unconstitutional. The appeal against the law had been brought by a Tulsa Abortion Centre and a Coalition for Reproductive Justice, which considered that the law restricted the options to abort by prohibiting the off-label use of drugs (i.e. for uses not initially authorised by the FDA) to induce abortion.

La entrada Progress in favour of life. Oklahoma restricts abortion pills aparece primero en Observatorio de Bioética, UCV.

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

Survival Needs and Growth Attenuation Therapy: Do They Signal a Need for a “Dependency Ethics”?

By John Banja, PhD

In 2006, the world learned about a child born with profound and life-long cognitive and physical disabilities who had undergone growth attenuation therapy (GAT) four years previously [1]. Called “Ashley” in media reports, she not only received the GAT—which consisted of administering high doses of estrogen over the span of a few years so as to staunch her physical growth—but she additionally had a hysterectomy, removal of her breast buds and an appendectomy. In response to international outrage that the child suffered these “mutilations” because she was disabled, her parents argued that these interventions would enable them to take better care of her, especially as she aged.
Image courtesy of Pixabay
GAT is back in the news with a New York Times magazine article [2] appearing March 22nd and an empirical study on parental perspectives recently published in the Cambridge Quarterly of Healthcare Ethics [3]. Children who receive GAT have an intellectual capacity that will likely never exceed that of a 1 year old, and they require 24 hour a day care throughout their lives. GAT typically consists in their receiving daily doses of estrogen between ages 3 and 6. The estrogen stimulates the premature closing of the growth plates or cartilaginous structures occurring at the ends of the long bones in their legs and arms, resulting in some reduction in height. About 75 percent of parents who choose GAT for their children do so because they are the child’s primary caregivers, and they justify their treatment decision in light of its facilitating both their and their child’s quality of life [2].

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

Guiding the Tide of Neurotechnology: Coordinating the Currents of Sea-Change

BY JAMES GIORDANO, PhD

 

Recently, the Food and Drug Administration (FDA) solicited input to guide ways that the agency regards and handles “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes”, in accordance with good practices regulation (21 CFR 10.115). The FDA will use this draft guidance to “…assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes”, and “… aid industry and FDA staff in considering the benefits and risks of medical devices that target … the cause or progression of neurological disorders or conditions” (such as movement disorders, like Parkinson’s disease and dystonia; as well as other pathologies, like Alzheimer’s dementia, Tourette’s syndrome, chronic pain, and psychiatric conditions such as depression).

The goal of the FDA regulation process is to establish that drugs and devices provided for medical care are safe and technically sound and the general constructs of Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) are aligned with such aims. But like any policies that tend to entail broad concepts, the real-world utility, viability and value of these programs are contingent upon: (1) the relative appropriateness to the context(s) in which any device is employed; and (2) if and how use-in practice reflects and is supported by the scope of regulatory oversight and control.

In recent years, IDE and HDE application, review and approval has become easier and more efficient; this is a notable improvement – and a step in the right direction.

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

F.D.A. Deal Allows Amarin to Promote Drug for Off-Label Use

March 10, 2016

(New York Times) – In a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday. The agreement settles a legal case between the agency and the company, Amarin, a small drug maker that sued the F.D.A. last year for the right to promote its only product, Vascepa, to a broader range of patients.

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

Pink Pill or Blue Pill?

Robyn MacQuarrie explains why she will continue to prescribe Viagra instead of Addyi to treat some women’s sexual dysfunction.

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I am a physician who often sees women who complain that sex isn’t fun. There are many reasons why women complain of dissatisfaction with their sex lives, one of which is decreased libido, or hypoactive sexual desire disorder. For those women, when I have ruled out other causes, I sometimes prescribe Viagra. This is an off-label use of Viagra.

Recently, a new drug—Addyi, or “pink Viagra,”—has been approved by the United States Food and Drug Administration to treat hypoactive sexual desire disorder. This drug has not yet been approved in Canada, but even if it were, it wouldn’t result in a change of practice for me.

Sexual dysfunction is a term used to describe a large group of disorders and conditions, all of which impact a woman’s sexual satisfaction. These include: decreased libido, difficulty with arousal, inability to achieve orgasm, pain with intercourse, and pain following intercourse. These problems often occur in combination with one another, have various potential causes, and aren’t always the result of an organic medical problem. For years, treating female sexual dysfunction was difficult for health care providers, as we had little to offer. Now that a new drug exists with an indication for hypoactive sexual desire disorder, I worry that health care providers will treat all causes of sexual dysfunction with a magic pink pill. There is no ONE simple cause of sexual dysfunction, and likewise there is not one simple solution.

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

Brain devices: Navigating collaborations between industry, government, and researchers

by Paul J. Ford, PhD

Dr. Ford is Director of the NeuroEthics Program at the Cleveland Clinic. He is an active clinical ethicist, and teaches ethics to medical students, residents, and fellows. His publications have appeared in Science, The Hastings Center Report, Neurology, Neuromodulation, and Journal of Medical Ethics. He is also a board member for AJOB Neuroscience.

This spring (June 3-4, 2015) the National Institutes of Health (NIH) as part of the BRAIN Initiative convened an eclectic group of individuals in hopes of encouraging more investigator initiated studies of currently approved neuromodulation and neuro recording devices for new indications (agenda, session videos, and program goals available here). The participants, both on the program and in the audience, specifically included industry, researchers, universities, and governmental agencies. I was delighted to participate in the workshop and was impressed by the number of sincerely interested parties across the spectrum of roles. Within these conversations it was apparent that there existed many shared values and goals as well as complex challenges for protecting particular interests. It beautifully highlighted the complexities of interactions among varied stakeholders.

Among the group there was a broad interest in performing due diligence in discharging their various duties to their constituents. At its heart, the meeting was a good faith effort to realize a desire to see innovations develop to the point of helping clinical populations, i.e. real people who suffer. This aspect of the BRAIN initiative recognizes the current significant logistical barriers to exploring new uses of existing devices within a research context.

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.