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Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Drug Trials. Show all posts
Showing posts with label Drug Trials. Show all posts

Tuesday, September 26, 2017

Drug company faked cancer patients to sell drug

Aaron M. Kessler
CNN.com
Originally published September 6, 2017

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

To boost sales, the company allegedly took patients who didn't have cancer and made it look like they did.

The drug maker used a combination of tactics, such as falsifying medical records, misleading insurance companies and providing kickbacks to doctors in league with the company, according to a federal indictment and ongoing congressional investigation by Sen. Claire McCaskill, a Democrat from Missouri.

The new report by McCaskill's office released Wednesday includes allegations about just how far the company went to push prescriptions of its sprayable form of fentanyl, Subsys.

Because of the high cost associated with Subsys, most insurers wouldn't pay for it unless it was approved in advance. That process, likely familiar to anyone who's taken an expensive medication, is called "prior-authorization."

The article is here.

Friday, September 1, 2017

A Plutocratic Proposal: an ethical way for rich patients to pay for a place on a clinical trial

Alexander Masters and Dominic Nutt
Journal of Medical Ethics 
Published Online First: 06 June 2017.

Abstract

Many potential therapeutic agents are discarded before they are tested in humans. These are not quack medications. They are drugs and other interventions that have been developed by responsible scientists in respectable companies or universities and are often backed up by publications in peer-reviewed journals. These possible treatments might ease suffering and prolong the lives of innumerable patients, yet they have been put aside. In this paper, we outline a novel mechanism—the Plutocratic Proposal—to revive such neglected research and fund early phase clinical trials. The central idea of the Proposal is that any patient who rescues a potential therapeutic agent from neglect by funding early phase clinical trials (either entirely or in large part) should be offered a place on the trial.

The article is here.

Wednesday, October 7, 2015

What the FDA’s approval of “pink Viagra” tells us about the problems with drug regulation

by Julia Belluz
The Vox
Originally published on September 18, 2015

Here is an excerpt:

The episode raised hard questions about the changes wrought by the patient movement and other reforms that have followed. There were excellent reasons for the FDA to bring HIV-positive patients into its deliberations in the 1980s — they provided a crucial perspective that the agency's in-house scientists and officials lacked. But these days, some critics argue that those listening sessions have been hijacked by drug companies. As I found in my reporting, the patients who had lobbied the FDA to approve pink Viagra were often sponsored by the drug's manufacturer.

"The role of pharma in patient groups in the contemporary era is entirely fraught," says Yale Law School's Gregg Gonsalves, who was once one of those HIV activists in the 1980s. "[Drug companies] learned from the early days of the AIDS epidemic that the patient community could be useful allies, and they've poured money into patient groups here in the US and around the world."

So is the FDA approving drugs too easily? Has the push for speed and efficiency now undermined the agency's ability to protect public health? To find out, I took a closer look at the approval of "pink Viagra," which offers a vivid illustration of just how much the FDA has transformed over time — and why those changes worry many experts.

The entire article is here.

Friday, May 22, 2015

Expansion of ‘Right to Try’ legislation raises ethical, safety concerns

By HemOnc Today
Originally published April 25, 2015

Early access to experimental drugs has historically been reserved for patients enrolled on clinical trials.

In 2009, the FDA revamped its 1980’s expanded access program, which allows terminally ill patients ineligible for clinical trials and for whom no alternative, approved therapies exist to ask pharmaceutical companies for access to an investigational drug in their pipeline. More than 1,500 patients received an experimental treatment through the FDA’s program in 2014.

Now, some legislatures are going a step further by adopting so-called “Right to Try” legislation, intended to give terminally ill patients comparable access to investigational drugs but removing the FDA from the process.

Since 2014, thirteen states have passed Right to Try laws, and legislators in 20 more states have plans to introduce similar legislation this year.

The entire article is here.

Tuesday, May 12, 2015

A Drug Trial’s Frayed Promise

By Katie Thomas
The New York Times
Originally published April 17, 2015

Here is an excerpt:

The University of Minnesota’s clinical trial practices are now under intense scrutiny. In February, a panel of outside experts excoriated the university for failing to properly oversee clinical trials and for paying inadequate attention to the protection of vulnerable subjects. The review, commissioned by the university after years of criticism of its research practices, singled out Dr. Schulz and his department of psychiatry, describing “a culture of fear” that pervaded the department.

In March, after another critical report by Minnesota’s legislative auditor, the university announced that it would halt all drug trials being conducted by the psychiatry department until outside experts could review them. And this month, the university announced that Dr. Schulz would step down as head of the psychiatry department. The dean of the medical school, Dr. Brooks Jackson, said in a statement to reporters that Dr. Schulz’s decision “was completely his own” and that he would “remain a valued member of our faculty.”

The entire article is here.

Friday, June 6, 2014

Leigh Turner Addresses University of Minnesota Board of Regents

Published on May 17, 2014

In a public meeting, Professor Leigh Turner of the University of Minnesota Center for Bioethics blasts the Board of Regents for defending psychiatric research abuse.


Wednesday, October 30, 2013

Pharmaceutical firms paid to attend meetings of panel that advises FDA

By Peter Whoriskey
The Washington Post
Originally published October 8, 2013

A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.

The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”

Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.

The entire article is here.

Friday, September 7, 2012

Do Post-Market Drug Trials Need a Higher Dose of Ethics?

Patients who sign up for trials testing more than one already approved intervention do not always know if one is being tested for harmful side effects

By Katherine Harmon
Scientific American
Originally published August 23, 2012

Here is an excerpt:

What you might not know—even after you sign up for the trial and have inked the informed-consent form—is that scattered reports are starting to suggest that the new medication might occasionally cause severe side effects. And the real reason the trial is being conducted with these previously released drugs is to test whether the new medication really is a lot riskier to everyone or just to a subset of patients.

If you found that out, would you still sign up for the trial? The problem is that many patients—and often even the institutional review boards that approve the trials—are never informed of these lingering questions.

This is one of the big ethical holes often left open in post-market trials, says Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, who co-authored a new essay on this topic in The New England Journal of Medicine, which was published online August 22. She and a team of co-authors released a formal Institute of Medicine (IOM) report earlier this year recommending that the FDA improve this and other ethical aspects of post-market trials—especially those it requires.