Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Off-Label Use. Show all posts
Showing posts with label Off-Label Use. Show all posts

Friday, March 18, 2016

Off-label Promotions: Pharma Wants More Freedom to Pitch Durgs

By Ed Silverman
Stat News
Originally published February 29, 2016

Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.

This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.

Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.

The article is here.

Friday, July 3, 2015

The rise of cognitive enhancers is a mass social experiment

By Emma A. Jane and Nicole A. Vincent
The Conversation
Originally posted June 15, 2015

Want to sign up for a massive human experiment? Too late. You’re already a lab rat. There was no ethics approval or informed consent. You weren’t asked, you never signed up, and now there’s no easy way to opt out.

We don’t want to be alarmist. We’re not suggesting you’re about to sprout wings, grow coarse hairs in surprising places and become a gruesome half-insect like the Brundlefly (the side effects of real life scientific experiments rarely impress like the special effects in David Cronenberg’s film The Fly).

But we do know not everyone wants to be a human lab rat. And yet we are all currently enrolled in a massive experiment involving cognitive enhancers.

(cut)

But what drugs, what devices? Well, take this guy, for instance, pumping electricity through his brain with a homegrown transcranial direct current stimulation (tDCS) device that emits a current so small it can run off a nine-volt battery. Or Elizabeth, the 20-something founder of a start-up who takes Adderall – a medication prescribed to treat attention deficit and hyperactivity disorder (ADHD) – except she doesn’t have ADHD.

The entire article is here.

Monday, June 15, 2015

The increasing lifestyle use of modafinil by healthy people: safety and ethical issues

By Sebastian Porsdam-Mann & Barbara J Sahakian
Current Opinion in Behavioral Sciences
Volume 4, August 2015, Pages 136–141

Pharmacological cognitive enhancers (PCEs) are used in the treatment of a variety of disorders, including targeting cognitive impairment and sleep abnormalities. Evidence suggests that PCEs also enhance cognition in healthy individuals. PCEs have attracted considerable interest recently, particularly from students, academics and the military. Proponents of PCE use in healthy people argue that these substances may be used to reduce fatigue-related and work-related accidents and improve learning outcomes.

In this article, safety concerns as well as ethical issues of fairness and coercion are considered. Discussion amongst experts in the field, government officials and members of society on the topic of the increasing lifestyle use of PCEs in healthy people is urgently needed.

The entire article is here.

Friday, November 15, 2013

Johnson & Johnson to pay over $2 billion to settle Risperdal investigations

By Joe Carlson
Modern Healthcare
Posted: November 4, 2013

In the largest-ever legal settlement for sales of a single drug, Johnson & Johnson has agreed to pay more than $2 billion and plead guilty to a misdemeanor charge of misbranding to end long-running investigations of its sales tactics involving Risperdal.

The New Brunswick, N.J.-based company and subsidiaries Janssen Pharmaceuticals and Scios told investors in August 2011 that they had agreed to settle allegations that J&J promoted its anti-psychotic Risperdal for off-label uses. On Thursday, company officials are scheduled to plead guilty in federal court.

The entire story is here.

Tuesday, August 20, 2013

Medicare Drug Program Fails to Monitor Prescribers, Putting Seniors and Disabled at Risk

by Tracy Weber, Charles Ornstein and Jennifer LaFleur
ProPublica
Published: May 11, 2013

Ten years ago, a sharply divided Congress decided to pour billions of dollars into subsidizing the purchase of drugs by elderly and disabled Americans.

The initiative, the biggest expansion of Medicare since its creation in 1965, proved wildly popular. It now serves more than 35 million people, delivering critical medicines to patients who might otherwise be unable to afford them. Its price tag is far lower than expected.

But an investigation by ProPublica has found the program, in its drive to get drugs into patients' hands, has failed to properly monitor safety. An analysis of four years of Medicare prescription records shows that some doctors and other health professionals across the country prescribe large quantities of drugs that are potentially harmful, disorienting or addictive. Federal officials have done little to detect or deter these hazardous prescribing patterns.

The entire story is here.

Sunday, May 19, 2013

Dangers found in lack of safety oversight for Medicare drug benefit

By Tracy Weber, Charles Ornstein and Jennifer LaFleur
ProPublica
Originally published: May 11, 2013

Here is an excerpt:

But an investigation by ProPublica has found the program, in its drive to get drugs into patients’ hands, has failed to properly monitor safety. An analysis of four years of Medicare prescription records shows that some doctors and other health professionals across the country prescribe large quantities of drugs that are potentially harmful, disorienting or addictive for their patients. Federal officials have done little to detect or deter these hazardous prescribing patterns.

Searches through hundreds of millions of records turned up physicians such as the Miami psychiatrist who has given hundreds of elderly dementia patients the same antipsychotic, despite the government’s most serious “black box” warning that it increases the risk of death. He believes he has no other options.

Some doctors are using drugs in unapproved ways that may be unsafe or ineffective, records showed. An Oklahoma psychiatrist regularly prescribes the Alzheimer’s drug Namenda for autism patients as young as 12; he says he thinks it calms them. Autism experts said there is scant scientific support for this practice.

The entire article is here.

Sunday, December 30, 2012

Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use


By ANDREW POLLACK and MOSI SECRET
The New York Times
Published: December 18, 2012

The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.

The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.

Amgen was “pursuing profits at the risk of patient safety,” Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.

David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.

Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.

The entire article is here.

Saturday, December 15, 2012

Court: Off-Label Drug Marketing Is 'Free Speech'


By John Fauber, Reporter
Milwaukee Journal Sentinel/MedPage Today
Originally Published: December 04, 2012


A decision by a federal appeals court this week could have a dramatic impact on the marketing of prescription drugs in America, potentially affecting patient care and everything from TV advertising to future government prosecutions which, in the past, had yielded billions of dollars in settlements, doctors and attorneys said Tuesday.

"This risks taking us back to an era when people could promote snake oil without restrictions – a situation I would hate to see," said Richard Deyo, MD, a professor of family medicine at Oregon Health and Science University.

Citizens United Redux

However, others say the ruling by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan is a victory for free speech, one that could become the drug industry equivalent of Citizens United, the 2010 U.S. Supreme Court decision that gave corporations and unions the right to spend unlimited sums on political ads.

Like the Citizens United case, the ruling Tuesday by the prestigious U.S. Court of Appeals for the Second Circuit in New York, involved the right of commercial free speech, applying it to the complicated world of pharmaceutical industry promotion of prescription drugs.

How wide-ranging the decision becomes likely will depend on whether it gets to the U.S. Supreme Court, attorneys said.

Once the Food and Drug Administration approves a drug, physicians are free to prescribe that drug as they wish -- but the drug makers can only market the drug for the FDA-approved marketing indication.

The case involves Alfred Caronia, a sales representative with Orphan Medical who was criminally prosecuted for making off-label promotional statements about Xyrem, a drug approved in 2002 to treat narcolepsy patients with a condition known as cataplexy. Cataplexy involves weak or paralyzed muscles.

The FDA required a black box warning on the drug stating that its safety and effectiveness had not been established in people under the age of 16. The active ingredient in Xyrem is GHB, is a powerful medication that acts on the central nervous system and also is known as the "date rape" drug.

The entire story is here.

Monday, October 8, 2012

A Dangerous Remedy (2 Letters)


Two Letters to the Editor from the New York Times published on October 1, 2012.

One is important to understand how psychotropics are currently being used on a daily basis and the second to underscore how psychological treatments are overlooked.

To the Editor:

Re “A Call for Caution on Antipsychotic Drugs,” (Mind, Sept. 25): “A call for caution” is indeed needed and long overdue to curb the inappropriate overuse of antipsychotics. As the author notes, the use of these highly potent and expensive drugs is drastically out of proportion to the appropriate target population: individuals with schizophrenia and bipolar disorder.

The misuse of antipsychotics in nursing homes in particular is a widespread yet preventable problem. Approximately one in four residents are given antipsychotics. The percentage of residents with dementia on these drugs is even higher. Too often, they are used as a form of chemical restraint, as a substitute for good care and adequate staffing. Contrary to what the article states, they are harmful for elderly people with dementia, greatly increasing the risk of stroke, heart attack, falls and even death.

Federal standards have long prohibited the inappropriate use of antipsychotics in nursing homes. With increased public knowledge and vigorous enforcement, hopefully we can make those standards a reality for vulnerable residents.

Richard Mollot

Manhattan

To the Editor:

There was no mention in Dr. Richard A. Friedman’s article about the proven effectiveness of psychological treatment, such as cognitive behavioral therapy, for nonpsychotic disorders. Instead, Dr. Friedman suggests that patients suffering from anxiety or depression take other, less powerful medications. By not recommending psychotherapy for the treatment of anxiety and depression, Dr. Friedman is perpetuating the mind-set that all psychiatric disorders should be treated with medicine, which in effect has created a climate that encourages the off-label use of antipsychotics.

Patricia Thornton

Manhattan

These can be found here.

Saturday, September 29, 2012

More U.S. Kids Prescribed Off-Label Antipsychotics: Study


By Mary Elizabeth Dallas
MedicineNet.com
Originally published on September 18, 2012

Over the past decade, off-label use of antipsychotic drugs has increased among children enrolled in Medicaid, according to a new study representing 35 percent of children in the United States.

Off-label drug use is a term used to describe when drugs are prescribed using a dosage, type of dosage or for a purpose that hasn't yet been approved by the U.S. Food and Drug Administration.

In the study, researchers from the Children's Hospital of Philadelphia found a 62 percent jump in the number of publicly insured children between the ages of 3 and 18 taking antipsychotics. In 2007 alone, 65 percent of the 354,000 children on these drugs were taking them for uses that have not been approved by the FDA, the investigators pointed out.

"We knew that the number of children prescribed antipsychotics had grown steadily over the past two decades, particularly among children with public insurance," study author Meredith Matone, a researcher at PolicyLab, said in a hospital news release. "With this study, we wanted to learn more about why these drugs are being used so often, what diagnoses they're being used to treat, and how prescribing patterns changed over the course of the last decade."


Tuesday, April 17, 2012

Military's increased use of medications under fire

Army has seen eightfold increase since 2005
by Kim Murphy
The Los Angeles Times
Originally published April 8, 2012

U.S. Air Force pilot Patrick Burke’s day started in the cockpit of a B-1B bomber near the Persian Gulf and proceeded across nine time zones as he ferried the aircraft home to South Dakota.

Every four hours during the 19-hour flight, Burke swallowed a tablet of Dexedrine, the prescribed amphetamine known as “go pills.” After landing, he went out for dinner and drinks with a fellow crewman. They were driving back to Ellsworth Air Force Base when Burke began striking his friend in the head.

“Jack Bauer told me this was going to happen – you guys are trying to kidnap me!” he yelled, as if he were a character in the TV show “24.”

When the woman giving them a lift pulled the car over, Burke leaped on her and wrestled her to the ground. “Me and my platoon are looking for terrorists,” he told her before grabbing her keys, driving away and crashing into a guardrail.

Burke was charged with auto theft, drunken driving and two counts of assault. But in October, a court-martial judge found the young lieutenant not guilty “by reason of lack of mental responsibility” – the almost unprecedented equivalent, at least in modern-day military courts, of an insanity acquittal.

The entire story is here.

Wednesday, March 28, 2012

A Bizarre Outcome on Generic Drugs

The New York Times
The Opinion Pages – Editorial
Originally published March 23, 2012

Dozens of suits against drug companies have been dismissed in federal and state courts because of a decision by the Supreme Court last year that makes it virtually impossible to sue generic manufacturers for failing to provide adequate warning of a prescription drug’s dangers. This outrageous denial of a patient’s right to recover fair damages makes it imperative that Congress or the Food and Drug Administration fashion a remedy.

This situation is particularly bizarre because patients using the brand-name drug can sue when those using the generic form of the drug cannot, as explained by Katie Thomas in The Times on Wednesday. In 2008, the Supreme Court ruled that a Vermont woman who had her hand and forearm amputated because of gangrene after being injected with a brand name antinausea drug could sue the manufacturer for inadequate warning of the risks; she won $6.8 million from Wyeth.

The entire editorial is here.

Tuesday, March 20, 2012

Antipsychotic Drugs Grow More Popular for Patients without Mental Illness

By Sandra G. Boodman
The Washington Post
Published March 12, 2012

Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia.

“It’s a total outrage,” said Fugh-Berman, a physician who is an associate professor of pharmacology at Georgetown University. “These kids needed some basic sleep [advice], like reducing their intake of caffeine and alcohol, not a highly sedating drug.”

Those Georgetown students exemplify a trend that alarms medical experts, policymakers and patient advocates: the skyrocketing increase in the off-label use of an expensive class of drugs called atypical antipsychotics. Until the past decade these 11 drugs, most approved in the 1990s, had been reserved for the approximately 3 percent of Americans with the most disabling mental illnesses, chiefly schizophrenia and bipolar disorder; more recently a few have been approved to treat severe depression.

But these days atypical antipsychotics — the most popular are Seroquel, Zyprexa and Abilify — are being prescribed by psychiatrists and primary-care doctors to treat a panoply of conditions for which they have not been approved, including anxiety, attention-deficit disorder, sleep difficulties, behavioral problems in toddlers and dementia. These new drugs account for more than 90 percent of the market and have eclipsed an older generation of antipsychotics. Two recent reports have found that youth in foster care, some less than a year old, are taking more psychotropic drugs than other children, including those with the severest forms of mental illness.

Wednesday, September 21, 2011

Antipsychotics overprescribed in nursing homes

By M. Price
September 2011, Volume 42, No. 8
Print Version: Page 11

Physicians are widely prescribing antipsychotics to people in nursing homes for off-label conditions such as dementia, and Medicare is largely picking up the bill, even though Medicare guidelines don't allow for off-label prescription reimbursements, according to an audit released in May by the U.S. Department of Health and Human Services Office of the Inspector General.

The findings underscore the fact that antipsychotics are often used when behavioral treatments would be more effective, psychologists say.

The office reviewed Medicare claims of people age 65 and older living in nursing homes in 2007—the most recent data at the time the study began—and found that 51 percent of all claims contained errors, resulting $116 million worth of antipsychotics such as Abilify, Risperdal and Zyprexa being charged to Medicare by people whose conditions didn't match the drugs' intended uses. Among the audit's findings are:
  • 14 percent of the 2.1 million elderly people living in nursing homes use Medicare to pay for at least one antipsychotic prescription.
  • 83 percent of all Medicare claims for antipsychotics are, based on medical reviews, prescribed for off-label conditions, specifically dementia.
  • 22 percent of the claims for antipsychotics do not comply with the Centers for Medicare and Medicaid Services' guidelines outlining how drugs should be administered, including those guidelines stating that nursing home residents should not receive excessive doses and doses over excessive periods of time.
The report suggests that Medicare overseers reassess their nursing home certification processes and develop methods besides medical review to confirm that medications are prescribed for appropriate conditions.

Why such high rates of overprescription for antipsychotics? HHS Inspector General Daniel Levinson argued in the report that pharmaceutical companies' marketing tactics are often to blame for antipsychotics' overprescribing. Victor Molinari, PhD, a geropsychologist at the University of South Florida in Tampa, says that another important issue is the dearth of psychologists trained to provide behavioral interventions to people in nursing homes. While he agrees that people in nursing homes are taking too much antipsychotic medication, he believes nursing home physicians are often responding to a lack of options.

Many nursing home administrators are quite savvy in their mental health knowledge and would prefer to offer their residents the option of behavioral treatments, Molinari says, but when residents need immediate calming, physicians will turn to antipsychotic medication because it's quick and available. Additionally, he says, many nursing home staff aren't educated enough about nonmedical options, so they go straight for the antipsychotics.

"It follows the saying, 'If your only tool is a hammer, everything is a nail,'" he says. "Nursing homes are not just straitjacketing residents with medications as a matter of course, but because there are a host of barriers to giving them optimal care."