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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

 
A digitalized image of a stem cell near hair follicles
From Scientific American:

Over the past few months, we have been flooded with emails from distressed parents asking whether their deaf child will be able to hear one day.

With each new email comes a poignant story about a child whose world is silent. It is estimated that hearing loss affects 11% of school age children and even mild loss may adversely influence school performance, cognitive development and language acquisition. The most common type of hearing loss, sensorineural, is the result of injury to the hair cells of the inner ear’s Organ of Corti, most commonly due to infections, medication, noise and aging.

Hair cells are mechano-transducers which convert sound energy received from the outer and middle ear structures into an electrical signal which is then transmitted by the cochlear nerve to the brain. If enough of a human’s 17,000 hair cells are damaged, then sufficient sound energy cannot be transmitted to the brain, and the result is hearing loss. While birds and reptiles replace damaged hair cells, mammals normally do not.

Although hearing aids and cochlear implants, the two main treatment modalities for sensorineural hearing loss (SNHL), have helped millions with impaired hearing around the globe, these devices do not restore or repair hearing. The idea of a cure has long been a dream for many parents of deaf children and the professionals who work with them. The sad reality, however, is that SNHL is currently considered irreversible. With the emergence of regenerative medicine and stem cell therapy, however, that dream may at last be within reach.

The Food and Drug Administration (FDA) has recently approved our groundbreaking trial to evaluate the safety of using a child’s own cord blood stem cells to regenerate damaged cells in the inner ear and potentially restore the child’s hearing. This trial builds on Dr. Baumgartner’s prior success treating traumatic brain injury (TBI) with stem cells, and encouraging pre-clinical data from Italy showing that cochlear damage in mice may be repaired by transplantation of human umbilical cord hematopoietic stem cells (HSC).

In the mouse study, researchers administered HSC intravenously to a mammalian mouse model in which permanent hearing loss had been induced by ototoxic medication, noise or both. Hair cell regeneration and repair of the Organ of Corti was only observed in mice that received HSC transplants. This experiment provided a proof of concept for our trial by suggesting that under certain conditions, mammals, like birds and reptiles, could replace their damaged hair cells.

Continue reading.

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Great Britain is beginning to recognize a problem with errors in prescription drugs. Patients there and in the U.S. need to be vigilant in checking their medications. We cannot afford to blindly trust that our doctor or pharmacist will not make a mistake. They are human and they DO make mistakes. Know your own medicines.


From The Telegraph: 



A unique study into prescribing errors by GPs found mistakes such as wrong dosages, lack of instructions and insufficient monitoring of patients on dangerous drugs were 'common'.
Elderly and young children are twice as likely to be given a prescription with an error because the over 75s are often on several drugs and the correct dose can be difficult to calculate in youngsters because it is usually based on body weight, the study found.
Time pressures during GP consultations are thought to be to blame along with complex computer software that makes it easy to select the wrong drug or incorrect dose from drop-down menus and frequent distractions and interruptions.
Several GPs said practice nurses who are responsible for managing some long-term conditions often asked them to sign prescriptions without seeing the patient and this made them 'uneasy' and also interrupted them during clinic meaning they may make mistakes themselves.
Also repeat prescriptions were often issued without questioning if the patient still needed the medicine, or if superior ones were available and results from separate clinics were often not relayed to the GP meaning drug doses were not adjusted, it was found.
Human error and not a lack of understanding or knowledge was behind most mistakes, the study said.
Extending the average GP consultation from 13 minutes to 15 and better training in safety would help, lead author, Prof Tony Avery, of Nottingham University, said.
Pharmacists and GP receptionists can also help by carrying out medicine reviews and checking monitoring arrangements.
Errors classed as severe included, a 62-year-old woman with a documented allergy to penicillin who was prescribed flucloxacillin, a similar drug, and elderly patients prescribed blood thinner warfarin, who should have been closely monitored but who were not tested for two years.
Moderate errors included a four-year-old girl with a stomach upset who was prescribed a drug that should be used 'with caution' in children.
Minor errors found in the study included a one-year-old girl who was given two prescriptions for antibiotics in the same consultation but with different doses stipulated.
Human error and not a lack of understanding or knowledge was behind most mistakes, the study said.
Extending the average GP consultation from 13 minutes to 15 and better training in safety would help, lead author, Prof Tony Avery, of Nottingham University, said.
Pharmacists and GP receptionists can also help by carrying out medicine reviews and checking monitoring arrangements.
Errors classed as severe included, a 62-year-old woman with a documented allergy to penicillin who was prescribed flucloxacillin, a similar drug, and elderly patients prescribed blood thinner warfarin, who should have been closely monitored but who were not tested for two years.
Moderate errors included a four-year-old girl with a stomach upset who was prescribed a drug that should be used 'with caution' in children.
Minor errors found in the study included a one-year-old girl who was given two prescriptions for antibiotics in the same consultation but with different doses stipulated.

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From Reuters:

The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body.

The Institute of Medicine, which often advises the government on scientific matters, said the FDA should then create a comprehensive, publicly available document that reflects risks that crop up throughout the "lifecycle" of the drug.

The FDA has been criticized for not quickly responding to dangerous side effects that become more evident after a product is brought to market, such as with Vioxx, a painkiller that Merck & Co In pulled five years after approval because of a link to heart attacks and strokes.

"It's impossible to know all the risks and benefits of a drug before approval," said Dr. Ruth Faden, co-chair of the IOM committee. The IOM called on the FDA to monitor drug safety at regular intervals over time.

The IOM's recommendations are not binding, and the FDA expressed some reservations about costs.

"We support the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs," said FDA spokeswoman Sandy Walsh.

"However, we feel it would be very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities."

Currently, the FDA must only check for new safety issues after the drug has been sold for 18 months, or after it has been used by 10,000 patients, whichever is later. It relies upon reports of side effects submitted by the drugmaker, doctors or patients.

The FDA did get greater power under a 2007 law to compel drugmakers to do additional post-approval safety trials or change their labels in response to new information, rather than relying on voluntary action from the companies.

In a report last month, the FDA said it now spends as much effort and resources on tracking a drug after it is approved as it does in the pre-approval process.

It said it has required companies to do 385 post-market studies since 2008, and to change the label based on new safety information 65 times.

Dr. Faden, who is also director of the Johns Hopkins Berman Institute of Bioethics, said extensive post-approval monitoring is critical because safety concerns with a drug may only become apparent once it has been used for many years, and by thousands of patients.

"We'd like to think that when a drug is approved, the evidence is like you need to convict someone at a murder trial: rock solid and without a shadow of a doubt," said Dr. Faden.

"But that's not a criterion the FDA could ever use and get drugs out to people in a reasonable amount of time. ... Exactly how that drug will fare once it's released is an open question."

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From Nature:


A petition to ban the diabetes drug Victoza (liraglutide) has turned the spotlight onto studies that demonstrate its potential to cause pancreatic and thyroid cancer.

“We don’t just go after drugs casually,” says Sidney Wolfe, director of the health and research group at Public Citizen, a non-profit consumer-advocacy organization based in Washington DC, which sent the petition to the US Food and Drug Administration (FDA) on 19 April. “We only go after drugs when there is clear evidence of unique dangers or risks, and when there is no evidence of a unique clinical advantage.”

Public Citizen says that Victoza has a number of possible side effects; of those, critics are most concerned about pancreatic cancer. Once that cancer spreads, a patient stands just a 1.8% chance of surviving for longer than five years.

The petition rests in part on the work of Peter Butler, an endocrinologist at the University of California, Los Angeles. For some years, his work has been fuelling a debate on Victoza and other drugs in the same class — but until now, that debate has been confined to diabetes investigators.

Victoza, made by Novo Nordisk of Bagsværd, Denmark, was approved by the FDA in 2010. It is the second diabetes drug to mimic the activity of a hormone called glucagon-like peptide-1 (GLP-1), which stimulates the release of insulin from the pancreas and ultimately lowers concentrations of glucose in the blood.

In some people, drugs that mimic GLP-1 may inflame the pancreas, causing pancreatitis — a risk factor for pancreatic cancer. In 2009, the FDA ruled that such drugs must be labelled with a warning about pancreatitis; Victoza carries that warning, as do Byetta and Bydureon, formulations of the GLP-1 mimic exenatide, made by Amylin Pharmaceuticals of San Diego, California. Wolfe says his concern extends to other diabetes drugs that alter the GLP-1 pathway, but there was stronger evidence to make a case against Victoza.

Since 2009, Butler and his colleagues have discovered that such treatments might affect the pancreas by activating GLP-1 receptor proteins, which in turn stimulate proliferation of precancerous cells. His latest finding1 is that human and rodent pancreases contain lots of GLP-1 receptors in areas in which cancer is thought to originate, and mice that are genetically predisposed to pancreatic cancer develop the disease more quickly than usual in response to Byetta.

Butler hypothesizes that treatments based on GLP-1 might lead to pancreatic cancer in people with pancreatic abnormalities that might otherwise have remained dormant. Similarly, GLP-1 receptors inhabit thyroid tissue, which Butler says could account for cases of thyroid cancer that occurred during clinical trials of Victoza2.

“Butler has put together a hypothesis which is interesting and needs to be investigated,” says Edwin Gale, an endocrinologist at the University of Bristol, UK. “Pancreatitis may be just the tip of the iceberg, and it’s the iceberg that concerns me.”

Continue reading.

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From The Huffington Post:


Prescription drug abuse and addiction is prevalent in America yet it lurks in the shadows. We don't like to talk about it because of the stigma associated with it. But if you are still reading this, you probably know someone close to you it has affected. This is an issue that is near and dear to me and my family.

Both of my parents own pharmacies (my father's is in Attleboro, Mass., and mother's is in Plainville, Mass.). Both have had their share of robberies from persons suffering from drug addiction. In September 2010, there was a well publicized case of a 17-year-old boy found nearly comatose in the ceiling of Plainville Prescription Center. That is my mother's store, and it wasn't the first break-in she or my father has experienced.

A few weeks ago, an old friend recently succumbed to a long fight with mental illness and she intentionally overdosed on pain killers -- mental illness is a serious risk factor for drug abuse. Another person close to my family, who has long suffered from back pain, also became a victim to pain killers, which many people fall victim to. He is currently in residential rehab with the full support of his family. Prescription drug addiction affects men and women, young and old, employed and unemployed, and those suffering from mental illness and those who don't. In short, no group is immune.

While I have never even had so much as a drink of alcohol in my life, (it may be hard to believe but it's true) before you question the type of people I surround myself with, facts are important and sometimes a wake-up call to the judgmental. Consider that in 2007, nearly 28,000 Americans died from unintentional drug poisoning, and of these, nearly 12,000 involved prescription pain relievers. Prescription drug abuse surged 400 percent from 2000-2010.

Drug addiction is a problem that can originate with chronic mental illness or legitimate physical or psychological pain. Drug addiction is a medical issue, not a moral one. Drug dealing, however, is a different issue, and to be clear, a serious crime. Some people think abuse or addiction are moral issues, some a criminal issue and others a medical issue. There is a difference between use, abuse, and addiction.
Illegal drug use and non-addictive abuse are cheap thrills for your brain's dopamine receptors (think of dopamine as the neurotransmitter in your brain that allows you to experience pleasure; without it, no pleasure). However, when abuse becomes addiction, we are talking about a physically altered brain. The brain becomes incapable of producing dopamine, or the pleasure receptors in the brain become incapable of receiving enough dopamine. The only way for some individuals to feel any pleasure, or no pain, is through excessive use of drugs. While drug experimentation may be a moral issue or an issue of poor judgement, drug addiction is more than a moral issue. In fact, I would not describe it as a moral issue at all. It becomes a physical one and one that is the equivalent of a hawk sinking its talons into prey.
Addiction is not something that someone can just snap out of.
One recent study found that over two-thirds of people who who used illicit drugs for the first time in one recent year began by using prescription drugs medically. In 2009, the number of first-time, non-medical users of psychotherapeutics (prescription opioid pain relievers, tranquilizers, sedatives, and stimulants) was about the same as the number of first-time marijuana users. Prescription drugs are the second-most abused category of drugs in the United States, following marijuana, which usually has much less serious consequences than prescription drug abuse and dependence.

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From The Boston Globe at boston.com:


Marjorie Bontempo was a changed woman after moving into Life Care Center of Nashoba Valley, a Littleton nursing home where the staff doesn’t believe in using antipsychotic drugs simply to calm residents.

A physician had prescribed an antipsychotic for Bontempo a year earlier, after Alzheimer’s disease had transformed her from an accomplished seamstress and demure family peacekeeper into a cantankerous, confused woman who refused to eat. The medicine eased her aggression but left her dazed, said her daughter, Patty Sinnett.
Nashoba’s nurses took Bontempo off the powerful sedative. Sinnett went to visit soon after and found her mother in the activity room watching a Clark Gable movie.
“She started explaining the whole movie to me, like a normal person would,’’ Sinnett said. “It was the first time I had had a conversation with her in a year. It was incredible.’’
The Littleton facility is one of a small but growing number of nursing homes that are treating the agitation and disruptive behavior that often accompany dementia without resorting to antipsychotics.
Instead, Life Care Center and similar homes try to tailor care to each resident, to make it familiar and comforting. Staffers comb residents’ pasts to learn their preferences, hobbies, and accomplishments, tapping bedrock emotions that endure long after memory fades.
The Globe reported Sunday that many homes still rely heavily on antipsychotics to deal with aggressive residents, though most of these residents do not have conditions that nursing home regulators say warrant use of the drugs. And federal authorities have warned of sometimes lethal side effects when antipsychotics are taken by elderly dementia patients.
Industry leaders say that the drugs must be used at times to protect residents and staff, and that many of the nondrug approaches being tried require specialized training that far too few nursing home workers have received, and often more staffing.
They note that drug regulators have not approved any medications specifically to manage the difficult behaviors exhibited by residents with dementia, and that physicians are allowed to prescribe antipsychotics “off-label’’ for conditions other than what they were designed for: serious mental illnesses such as schizophrenia.
Overall use of the drugs in nursing home patients without mental illnesses has declined since 2005, according to the Globe’s analysis of federal data. The numbers show that Nashoba drove down its use of antipsychotics from six years ago, when nearly a quarter of residents without illnesses warranting antipsychotic use received them anyway. In 2010, that number was zero.
The linchpin was a new director of nursing, Nancy LaRock, who scoured each patient’s files and discovered that roughly 30 of the home’s 120 residents were on antipsychotics. Easily half of them didn’t have a condition that would warrant the medications.
LaRock, who had a background in psychiatric care, started weaning residents off the medications and training staff about alternative strategies.
“One of the biggest challenges was from families,’’ she said. “I got some push-back from families who wanted mom to have this drug because she was so much easier to be with,’’ LaRock said. “As far as I’m concerned, the antipsychotic masks who that person really is.’’
From the circular layout of its Alzheimer’s unit - so residents don’t encounter a dead-end in a hallway, a potential source of stress for those who wander - to the goats and llamas grazing in its pastoral front yard, Nashoba stands out.
Executive director Ellen Levinson, whose two golden retrievers often greet visitors at the front door, said she has found that animals have a calming effect. The walls of the 27-bed Alzheimer’s unit are lined with animal pictures, and bird feeders hang from nearly every window.
A caretaker sometimes leads the llamas through the halls and into the Alzheimer’s unit, where even residents who relentlessly wander stop to pet the regal creatures.
Activities and care are matched to residents’ individual personalities and abilities.
For 88-year-old Richard Pinkham, a former electrician, staffers assembled a “tool box’’ full of paint brushes, measuring tapes, and other gadgets so he can still dabble.
They found that Bontempo, who wasn’t eating when she first arrived in 2010, loves hot chocolate - any time of day, any time of year. Now they bring her a cup at the start of every meal, which jump-starts her appetite. And she is rarely aggressive.
“Margie really enjoyed dancing, so we try to talk to her about that,’’ said Erica Labb, program director of Nashoba’s dementia care unit. “It is often trial and error and we just keep trying new things until we find the right combo.’’
Many of the residents are no longer able to speak, so their behaviors - tears, screams, slapping, smiles - are how they communicate.
“If someone is combative during a shower, it may be that she is afraid, so we may start with just her feet,’’ Labb said.
Staffers ask family members detailed questions about a resident’s personality before Alzheimer’s set in: the time of day they preferred bathing, favorite foods, hobbies, cherished accomplishments.

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