Tag: drugs

Bioethics News

‘Breakthrough’ Leukemia Drug Also Portends ‘Quantum Leap’ In Cost

August 23, 2017

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“From what we’re hearing, this will be a quantum leap more expensive than other cancer drugs,” said Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York.

Switzerland-based Novartis hasn’t announced a price for the medicine, but British health authorities have said a price of $649,000 for a one-time treatment would be justified given the significant benefits.

The cancer therapy was unanimously approved by a Food and Drug Administration advisory committee in July, and its approval seems all but certain.

… Read More

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KHN

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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

Double Dutch euthanasia evokes sympathy through age and romance

by Craig Klugman, Ph.D.

O true apothecary!
Thy drugs are quick. Thus with a kiss I die.
– Romeo & Juliet, Act 5, Scene 3

In a scene reminiscent of Romeo and Juliet, a Dutch couple were voluntarily euthanized together after sharing their final kiss. Nic Elderhorst, 91, had a stroke 5 years ago that left him with limited mobility and chronic pain. Trees, 91, his wife and primary caregiver, had declining physical health and was diagnosed with vascular dementia. She feared that she could no longer care for him. Both feared living without the other and had stated for a long time that they had hoped to die together.

Headlines around the world focused on the romance of their euthanasia. “Dying Together was their deepest wish” declared one British paper. Another said “Loving couple, 91, pass away in rare double euthanasia” not only showing the romance, but changing the active process of killing to the metaphor of “passing away.” “Elderly couple got ‘deepest wish’ declared the Washington Post. “Elderly couple kiss, hold hands before double-euthanasia” was published in New Zealand.

The Netherlands is one of the few countries in the world that permits voluntary euthanasia, where a physician administers a drug to fulfill a person’s request to end his/her life. To qualify, a patient must make a considered request, have unbearable and hopeless suffering, be informed about the situation and future possibilities, and have no reasonable alternatives. Thus, a person does need to have a “terminal illness” or “irreversible condition” in order to request and receive life-ending procedures.

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

Chess Study Revives Debate Over Cognition-Enhancing Drugs

August 17, 2017

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About a decade ago, reports filled the general and scientific media about the illicit use of such CEs as methylphenidate, a stimulant used to treat attention-deficit/hyperactivity disorder (ADHD), and modafinil, a wakefulness agent used to treat narcolepsy, sleep apnea, and shift work disorder, by students and others who were taking them to improve performance on examinations or in the workplace. There were stories about the risks and ethics of such behavior, countered by calls from some neuroscientists for a more open mind about the drugs and their positive side. The field of brain augmentation was even given a chic new name, cosmetic neurology.

While media attention has since waned, the underground use of CEs seemingly has not. A 2013 survey found that 19.9% of the 1105 German surgeons who responded admitted to having taken a prescription or illicit drug to enhance cognition at least once. Another study found that 61.8% of undergraduates at the University of Maryland had been offered prescription stimulants for nonmedical purposes, most of them by friends with prescriptions, and 31% had used them.

And the trend “hasn’t peaked yet,” noted Barbara Sahakian, DSc, a professor of clinical neuropsychology at the University of Cambridge who investigates the effectiveness of CEs in treating the cognitive impairment associated with certain psychiatric disorders.

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Image: Von M.R.W.HH in der Wikipedia auf Deutsch – Übertragen aus de.wikipedia nach Commons., Gemeinfrei, https://commons.wikimedia.org/w/index.php?curid=1918499

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JAMA

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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

Opioid Overdoses Leading to More ICU Admissions and Deaths

August 17, 2017

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“People who use injection drugs should obtain naloxone, the overdose reversal drug, and use drugs with partners who can help them,” said Brendan Saloner, a researcher at the Johns Hopkins Bloomberg School of Public Health in Baltimore who wasn’t involved in the study.

In many states, family members can get naloxone, sometimes without a prescription, Saloner said by email. Two medications, buprenorphine and methadone, can also help reduce drug use.

“There is unfortunately a lot of stigma about medication treatments, but they are safe and work,” Saloner added. “Long-term change is possible and recovery is a realistic goal, but it requires time and patience.”

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Image: By Bullenwächter – Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=17856929

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Reuters

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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

Drugs that Go Through FDA’s Expedited Review Might Be Better Drugs

August 14, 2017

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A new paper in the latest issue of Health Affairs is worth a look. “Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process“:

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999–2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes.

The FDA has a strict process for drug approval, requiring a number of phases of testing to establish safety and efficacy. It can, however, expedite this process when it thinks a drug may address an unmet clinical need. Of course, you want such a process to be fair and work. You want it to be focused on “better” and “more important” drugs. The 21st Century Cures Act moved even further. Some worry that loosening standards will lead to increased exposure to harm, especially if there isn’t proof that these drugs provide more benefits.

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The Incidental Economist

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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

Pregnancy Paradox

The dangers of not testing drugs on pregnant women. Pregnant women can get sick. And women with illnesses do get pregnant. Yet most drugs have never been tested for their effects during pregnancy

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

Erika Lietzan on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! This week’s TWIHL is a deep dive into pharmaceutical patent protection and its intersection with the FDA new drug approval process. We touch on molecular drugs, biosimilars, data exclusivity, market exclusivity, the runway to generics, and fascinating differentials … 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

Topsy-Turvy Brand Name Drug Pricing?

On August 7, 2017, The
New York Times
with ProPublica
(an independent, non-profit investigative new agency) reported
that some drug companies have struck deals with insurers to require that
prescriptions be dispensed for the more expensive brand name drug rather than
the less expensive generic alternative! Has the world turned upside down? What
has happened? Perhaps one could respond: Follow the money.

Pharmaceutical companies have apparently cut a deal with
health insurance companies and pharmacy benefits managers for some drug
products so that middle men pay prices that are very competitive, at least as
competitive as the generic equivalents. In one arrangement for a particular
drug – Shire’s Adderall XR, used to treat attention deficit hyperactivity
disorder (ADHD) – UnitedHealthcare insured patients were provided a discount
coupon which lowered the cost of the brand name considerably, but a patient’s
family still payed about $50 more a month than for the generic. Consumers
clearly are bearing the increased costs.

A spokesman for United Healthcare defended the program: “By
providing access to these drugs at lower cost, we are able to improve
affordability for our customers and members.” Of course, the statement is true,
but it is a poor justification because in this instance have no choice in the
matter. Even if patients’ physicians write for the generic equivalent, the
doctors are told that they “had to specify that patients required brand-name
versions of the drug.” This may or may not be true depending on the health
insurers’ and pharmacy benefits managers’ formulary requirements; but it may be
a moot point if the band name drug is the only one available, or unless the
patient wants to pay full price for a drug product that is not listed in the
formulary.

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

Topsy-Turvy Brand Name Drug Pricing?

On August 7, 2017, The
New York Times
with ProPublica
(an independent, non-profit investigative new agency) reported
that some drug companies have struck deals with insurers to require that
prescriptions be dispensed for the more expensive brand name drug rather than
the less expensive generic alternative! Has the world turned upside down? What
has happened? Perhaps one could respond: Follow the money.

Pharmaceutical companies have apparently cut a deal with
health insurance companies and pharmacy benefits managers for some drug
products so that middle men pay prices that are very competitive, at least as
competitive as the generic equivalents. In one arrangement for a particular
drug – Shire’s Adderall XR, used to treat attention deficit hyperactivity
disorder (ADHD) – UnitedHealthcare insured patients were provided a discount
coupon which lowered the cost of the brand name considerably, but a patient’s
family still payed about $50 more a month than for the generic. Consumers
clearly are bearing the increased costs.

A spokesman for United Healthcare defended the program: “By
providing access to these drugs at lower cost, we are able to improve
affordability for our customers and members.” Of course, the statement is true,
but it is a poor justification because in this instance have no choice in the
matter. Even if patients’ physicians write for the generic equivalent, the
doctors are told that they “had to specify that patients required brand-name
versions of the drug.” This may or may not be true depending on the health
insurers’ and pharmacy benefits managers’ formulary requirements; but it may be
a moot point if the band name drug is the only one available, or unless the
patient wants to pay full price for a drug product that is not listed in the
formulary.

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.