Tag: therapeutics

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Problematic Pharmaceutical Pricing as an Investor Collective Action Problem?

The U.S. Senate Special Committee on Aging recently released its report Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Harms Patients, Taxpayers, and the U.S. Health Care System (hereinafter Report).  Using four companies as case studies—Turing Pharmaceuticals, Retrophin, Valeant Pharmaceuticals International, and Rodelis Therapeutics—this Report specifically investigates one corner of recent drug pricing controversies: dramatically increased prices on old off-patent pharmaceuticals.  Per the Report, these companies pursued a business model that sought to “identify and acquire off-patent sole-source drugs over which they could exercise de facto monopoly pricing power, and then impose and protect astronomical price increases.”[1]

For a variety of reasons, these particular price increases are morally troubling.  It’s not just that these increases may be exploitative.  The plain human consequences of these businesses’ brazen, yet seemingly legal, decisions are gravely concerning.  These corporate actions harm patients in need of the companies’ drugs, the families and physicians who care for those patients, and the healthcare system that helps pay the tab.

What’s driving this morally concerning behavior?  A common refrain points to weak government regulation.  No doubt improvements can be made, but a significant and seemingly oft overlooked part of the answer may point to investors.  What role have investors played in pricing controversies and what role ought they to play?

The Report suggests that prominent shareholders were often in contact with the senior management of the investigated pharmaceutical companies.  These investors, even if not outright encouraging price increases, at least appear complacent.  Examples include:

  • A partner from Broadfin Capital, a major investor in Retrophin Inc.,

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.

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2016’s Worst Clinical Trial Failures

December 23, 2016

(Managed Care Magazine) – Several costly trial failures have made 2016 a depressing year for drug makers, according to Motley Fool analyst Cory Renauer. Bristol-Myers Squibb, Juno Therapeutics, Celldex Therapeutics, and Clovis Oncology all learned how hard it is to score a touchdown in the oncology game. Eli Lilly and Biogen, too, stubbed their toes with failed neurology drugs. Renauer reviewed seven initially promising medications that ultimately delivered nothing but heartbreak to their developers.

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.

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Deaths in Immune-Therapy Trials Haunt Promising New Cancer Treatment

December 2, 2016

(MIT Technology Review) – The deaths last month of two patients in a clinical trial testing a promising new type of cancer treatment are raising questions about the fate of therapies that use a patient’s own immune cells to fight off the disease. Juno Therapeutics, the Seattle company conducting the trial, announced it was halting its human tests of an experimental cancer therapy just before Thanksgiving after two patients with acute lymphoblastic leukemia died. Earlier this year, three patients died in the same clinical trial. But other investigators developing similar products are forging on with testing the new class of therapies, which have shown incredible promise for some patients with lethal cancers.

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.

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After Eteplirsen: Duchenne Stakeholders Contemplate What Comes Next

(Chemical & Engineering News) – On Sept. 19, the Food & Drug Administration announced it had granted “accelerated approval,” a conditional stamp based on limited data, to Sarepta Therapeutics’ Duchenne muscular dystrophy treatment eteplirsen. The agency’s decision closed a tumultuous chapter for a rare disease community and opened a new one about how drugs should be tested and reviewed. Eteplirsen, the first drug for a deadly disease that affects children, was one of the most closely watched treatments in the pharmaceutical industry. It had also become one of the most contentious.

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.

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3-person IVF and Infertility: What Kind of Slippery Slope is This?

Reacting to two breaking news stories about 3-person in vitro fertilization (IVF) in less than two weeks, Paul Knoepfler, professor and stem cell researcher at UC Davis, recently tweeted:

On September, 27, 2016, news broke that NYC-based fertility doctor John Zhang and his team had delivered a baby the previous April that they created using a controversial mitochondrial manipulation technique, also known as 3-person IVF, that results in an embryo with DNA from three people. The baby was born in Mexico in order to avoid US regulation, as Zhang explicitly admitted. Despite the multiple violations of medical ethics involved, the media craze that followed largely made a hero of Zhang, depicting him as a doctor altruistically seeking to prevent the transmission of mitochondrial disease.

The prevention of mitochondrial disease has been the core justification cited all along for permitting these controversial, high-risk techniques that represent a form of inheritable genetic engineering, also known as human germline modification.

On October 10, news broke that Valery Zukin, a fertility doctor at the Nadiya Clinic in Kiev, Ukraine, had used 3-person IVF not to lower the risk of mitochondrial disease, but as a treatment for infertility.

The media in this case was surprisingly quiet, perhaps because Zukin had supplied no published evidence of his claim, although the BBC did publish a somewhat critical piece entitled “3 person baby ‘race’ dangerous.” On October 19 Nature News reported a claim that yet another baby conceived using some kind of mitochondrial manipulation technique has been born, this time in China.

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.

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Sonya E. Pritzker’s Living Translation: Language and the Search for Resonance in U.S. Chinese Medicine by Miao Jenny Hua

Living Translation: Language and the Search for Resonance in U.S. Chinese Medicine

by Sonya E. Pritzker

Berghahn Books, 2014, 228 pages

By: Miao Jenny Hua

Chinese medicine names at least five components to the spiritual part of the embodied self, corresponding to each of the five organ-systems. The shen-spirit is associated with the heart, the yi-spirit with the spleen, po with the lungs, zhi with the kidneys and hun with the liver. These are not just technical jargon; each “spirit” has distinct connotations in everyday life. But how does one capture such subtle variations with actionable precision in the context of clinical Chinese medicine in the United States?

This is the kind of daunting question that Sonya Pritzker’s Living Translation addresses with exquisite ethnographic detail. Denying from the start that she is providing a how-to guide on translating Chinese medicine, Pritzker instead portrays the variable ways in which translations are enacted (2). With an eye to the world-making effects of practice inspired by Annemarie Mol (2002), “enact” is a capacious enough verb for Pritzker to capture translation as multiple modes of making lived equivalences. An ongoing process from monographs to conferences, classrooms to clinics, theoretical arguments over translation are never fully settled and clinical remedies in translation are rarely neatly reductive.

In the early twentieth-century, “Chinese medicine” was constituted as a defensive response to the discrediting advances of modern science and biomedicine in China (25). In the 1960s and 1970s, Chinese medicine was swept up as part of the New Age Movement in the United States, eventually achieving widespread institutional recognition as a form of Complementary and Alternative Medicine (CAM).

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.

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Megan Crowley-Matoka’s “Domesticating Organ Transplant: Family Sacrifice and National Aspiration in Mexico” by Parsa Bastani

Domesticating Organ Transplant: Family Sacrifice and National Aspiration in Mexico

Megan Crowley-Matoka

Duke University Press, 2016, 336 pages

 

In Domesticating Organ Transplant: Family Sacrifice and National Aspiration in Mexico, Megan Crowley-Matoka carefully grapples with the symbols and everyday practices of organ transplantation in Guadalajara, Mexico. Her research focuses on transplantations that take place in two resource poor yet key public healthcare systems at the helm of transplant medicine in Mexico. Through detailed ethnographic engagement with clinicians, government officials, patients, and their families, Crowley-Matoka follows the discursive life of multiple icons that have come to shape organ transplantation in locally particular ways. These icons are various and woven throughout the text, including la familia mexicana, the suffering mother, el mestizo, and “the slipper state.” The theoretical framework of the icon allows her to analyze the powerful and contested representations by which transplantation is signified and materialized in Mexico.

In developing her analysis, Crowley-Matoka most consistently draws on the icon of la familia Mexicana or the cohesive and self-sacrificial Mexican family. She argues that organ transplantation is a domesticated endeavor. As such, the Mexican family holds iconic currency on multiple scales. For the biomedical establishment, the evocation of “la familia” functions as a cultural and moral technology that has enabled Mexico to excel in transplantation from living donors. In the national imaginary, organs are understood to move from mothers to their (male) family members (Chapter 1). For transplant professionals and patients, the ideal outcome of transplantation is yoked to the attainment of a (hetero) normative Mexican family (Chapter 4).

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.

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Megan Crowley-Matoka’s “Domesticating Organ Transplant: Familial Sacrifice and National Aspiration in Mexico” by Parsa Bastani

Domesticating Organ Transplant: Familial Sacrifice and National Aspiration in Mexico

Megan Crowley-Matoka

Duke University Press, 2016, 336 pages

 

In Domesticating Organ Transplant: Familial Sacrifice and National Aspiration in Mexico, Megan Crowley-Matoka carefully grapples with the symbols and everyday practices of organ transplantation in Guadalajara, Mexico. Her research focuses on transplantations that take place in two resource poor yet key public healthcare systems at the helm of transplant medicine in Mexico. Through detailed ethnographic engagement with clinicians, government officials, patients, and their families, Crowley-Matoka follows the discursive life of multiple icons that have come to shape organ transplantation in locally particular ways. These icons are various and woven throughout the text, including la familia mexicana, the suffering mother, el mestizo, and “the slippery state.” The theoretical framework of the icon allows her to analyze the powerful and contested representations by which transplantation is signified and materialized in Mexico.

In developing her analysis, Crowley-Matoka most consistently draws on the icon of la familia Mexicana or the cohesive and self-sacrificial Mexican family. She argues that organ transplantation is a domesticated endeavor. As such, the Mexican family holds iconic currency on multiple scales. For the biomedical establishment, the evocation of “la familia” functions as a cultural and moral technology that has enabled Mexico to excel in transplantation from living donors. In the national imaginary, organs are understood to move from mothers to their (male) family members (Chapter 1). For transplant professionals and patients, the ideal outcome of transplantation is yoked to the attainment of a (hetero) normative Mexican family (Chapter 4).

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.

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A Golden Ticket That Fast-Tracks a Drug Through the FDA

September 29, 2016

(Kasier Health News) – Drugmaker Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was recently approved, but the company had other reasons to celebrate, too. They were also awarded the drug world’s equivalent of a Willy Wonka golden ticket. The ticket, known as a rare pediatric disease priority review voucher, is part of a program created by Congress in 2007 to encourage the development of drugs for tropical diseases and later expanded to rare pediatric disorders. Any company awarded a voucher can use it for a fast-track government review of one of its future drugs — or it can sell the voucher to another 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.