Tag: drugs

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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.”

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

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Reuters

Tags: bioethics, brendan saloner, health policy, mortality, opioid, overdose, public health, safe house, safety, treatment

Read more at bioethicsbulletin.org

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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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

Tags: access, alternative, bioethics, clinical trial, drugs, efficacy, evidence, expedited review, FDA, safety, subject, treatment

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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

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After French Drug Trial Tragedy, EU Issues New Rules to Protect Study Volunteers

August 4, 2017

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The European Medicines Agency (EMA) has issued new, stricter rules for studies that test drugs in people for the first time. They aim to better protect participants in such first-in-human studies—often healthy volunteers who receive a financial reward.

The guideline, which was issued on 25 July, will take effect in February 2018. It comes in the wake of a tragedy in a French drug study last year that led to the death of one man and serious neurological damage in four others. But some say the revision isn’t going for enough.

The new guideline emphasizes that drug developers must perform comprehensive preclinical tests of a new compound, including how it binds to its target and whether it has so-called off-target effects; experts argue such studies fell short for the French study. EMA also provides more detailed guidance on dosing and how to monitor subjects’ safety. Trial sponsors need to have strategies to minimize risks at every step and have to deal with adverse events timely and adequately.

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Science Magazine

Tags: benefits, bioethics, changes, drug trial, ema, harm, human subjects, oversight, protections, risks

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Guess Who’s Tracking Your Prescription Drugs?

August 3, 2017

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As drug overdose deaths continue their record climb, Missouri last month became the 50th state to launch a prescription drug monitoring program, or PDMP. These state-run databases, which track prescriptions of certain potentially addictive or dangerous medications, are widely regarded as an essential tool to stem the opioid epidemic. Missouri Gov. Eric Greitens last month announced he was creating one in what had been the lone holdout state; legislative efforts to establish a program there had repeatedly failed because of lawmakers’ concerns about privacy.

Their concerns were not unfounded.

Federal courts in Utah and Oregon recently ruled that the Drug Enforcement Administration, in its effort to investigate suspected drug abusers or pill mills, can access information in those states’ PDMPs without a warrant, even over the states’ objections. And last month in California, the state supreme court ruled that the state medical board could view hundreds of patients’ prescription drug records in the course of its investigation of a physician accused of misconduct. “Physicians and patients have no reasonable expectation of privacy in the highly regulated prescription drug industry,” District Judge David Nuffer wrote in the Utah case.

Image via Flickr Some rights reserved by sfxeric

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The Marshall Project

Tags: abuse, bioethics, crime, docs, opioid, patients, police, prescription, privacy, tracking, use

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Guidelines Needed to Help Terminally Ill Patients Gain Access to Trial Drugs

Stacey Lee, an assistant professor at JHU’s Carey Business School, suggests a more transparent process for patients

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Human tissues and organs produced using 3D techniques

In recent years, many efforts have been made by scientists and biomedical engineers to develop ex-vivo models of human tissues and organs using 3D printing techniques (see our report HERE) for various purposes. In particular, the potential organoids using 3D techniques can be used to assess the functions of different human organs, deepen our understanding of various diseases, and also serve as a substrate for experimentation with new drugs. Now, a webinar in Nature (nature.com webcasts) has evaluated the possibility of detecting specific drugs for the treatment of malignant tumors, especially colorectal tumors. Using this technique, they evaluated more than 3000 molecular compounds that have been identified and validated to prevent the recurrence of colorectal cancer, which, from a medical and bioethical point of view, is very positive.

La entrada Human tissues and organs produced using 3D techniques aparece primero en Bioethics Observatory.

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Organ donation for transplantation in children with cardiac arrest and dying person dignity

Premortem interventions before donation in circulatory arrest in children could have objective ethical problems

(See our special reports about criterion of death and organs transplantation HERE)

Up until a few years ago, performing medical interventions in end-of-life situations had been proposed as actions centered on the best interests of the dying patient.

The growing demand for organs for transplantation has created a need to increase the number of organ donors (see HERE).

Since the number of brain-dead donors is currently insufficient to meet the needs of patients on the transplant waiting list, medical procedures have been developed in the last decade aimed at ensuring that the organs from donors in cardiac arrest are also suitable for successful solid organ transplantation (see HERE our article about the relation between excellent figures of organ donation and organ donors with cardiac arrest in Spain).

Nevertheless, in order to achieve sufficient organ viability in donors with cardiac arrest, a series of medical procedures need to be performed that have the main aim of reducing the warm ischaemia time to which these organs are subjected, in order to increase the chances of post-transplant success.

An article has recently been published in the Journal of Medical Ethics (1) “Premortem interventions in dying children to optimise organ donation: an ethical analysis”, whose authors Joe Brierley and David Shaw analyze the ethical and legal aspects of premortem interventions performed in dying children, aimed at optimizing organ donation for transplantation following cardiac arrest.

Premortem interventions in pediatric patients for organ donation from an ethical perspective

This article examines the legislative aspects (specific to the United Kingdom), and also gives a description and analysis of the elements that, from an ethical perspective, might support – or contradict – the performance of premortem interventions in pediatric patients for organ donation.

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Tennessee Inmates Consenting to Vasectomies or Birth Control Implants Offered Reduced Time

If Tennessee inmates consent to receiving a free vasectomy or birth control implant, Judge Sam Benningfield has ruled that they can have their jail time reduced by up to thirty days. Critics are claiming that the initiative violates inmates’ constitutional rights, amongst them the American Civil Liberties Union and numerous district attorneys. Advocates are claiming that the program, in effect since May 15th, precludes the potential burden of childrearing for otherwise unintentional parents.

In response to the backlash, Benningfield has emphasized that the procedures are reversible and do not involve sterilization. According to Reuters, he said that “the idea grew out of an earlier program he created with the state’s Department of Health under which inmates’ sentences were reduced by two days if they completed an education program on the risks of raising children while using illegal drugs… Unplanned and unwanted children and the resulting obligations complicate their lives and make their reintegration into society more difficult.”

Nashville’s News Channel 5, which drew attention to the program earlier this week, has stated that 32 women have received the four-year birth control implant and 38 men have signed up for vasectomies. Initially designed for women at risk of birthing children with drug dependencies, the program now encompasses procedures for both sexes in order to avoid discriminatory practices.

“We do not support any policy that could compel incarcerated individuals to seek any particular health services,” said a spokeswoman for Tennessee’s Department of Health. Despite assurances from Benningfield about the procedures’ reversibility, District Attorney Bryant Dunaway said that “it’s comprehensible that an 18-year-old gets this done, it can’t get reversed and then that impacts the rest of their life.”

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Eugenics in Tennessee

A recent news story from my home state of Tennessee brings up questions of informed consent, reproductive ethics, eugenics, opioid abuse, and other bioethical issues. In May, White County judge Sam Benningfield issued an order that allows inmates to have their sentences reduced by thirty days if they consent to sterilization procedures: vasectomies for men and (reversible) Nexplanon implants for women. Benningfield’s order is his response to the repeat drug offenders he sees in the courtroom. He describes the sterilizations as a means to “encourage personal responsibility,” and also states that, “…if you reach two or three people, maybe that’s two or three kids not being born under the influence of drugs. I see it as a win, win.”

This order is less surprising, perhaps, when considered in light of the United States’ very recent history of eugenics and forced sterilizations. As Kyle Sammin writes at The Federalist,

“[Benningfield’s] idea of ‘trying to break a vicious cycle of repeat offenders’ is, nearly word-for-word, an echo of the Supreme Court’s reasoning in Buck v. Bell, the 1927 case that upheld Virginia’s policy of sterilizing state asylum inmates without their consent. The decision by Justice Oliver Wendell Holmes laid out a similar desire to break a cycle of reproduction by people the judge viewed as unworthy of life: ‘It is better…if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind….Three generations of imbeciles are enough.’”

Benningfield’s order deems inmates’ potential future children as unworthy of life because of their parents’ situations.