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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.

 


We wish all our readers a safe, healthy and peaceful Thanksgiving. 
We have much to be thankful for, 
although we might not always remember that. 
It's nice to have a day to think about what's really important 
and give thanks for our many blessings.


 
This article was of particular interest to me because I've inhaled Advair twice a day for several years now. Since I have only mild asthma, I plan to discuss alternatives during my next visit with my doctor.

From MedPage Today:


The 2001 product launch of the asthma drug Advair (fluticasone/salmeterol) was a lavish, Las Vegas affair.

Using images of a slot machine to illustrate their message, top GlaxoSmithKline executives took the stage in front of thousands of assembled sales reps. "There are people in this room who are going to make an ungodly sum of money selling Advair," one executive told the group.

He was right.

The Serious Business of Asthma

Millions of people with asthma, including many children, have gone on the drug and, according to data from IMS, Advair sales have exceeded $4 billion every year since 2007.

Yet even as profits mounted evidence began to emerge from independent medical studies and court records suggesting that the drug can be dangerous, especially to children and that overuse of the drug exacerbated the danger.

Asthma is not a benign condition.

According to the U.S. Centers for Disease Control and Prevention, asthma deaths in the U.S. have been declining since the late 1990s. In 2009, there were 3,388 asthma deaths.

The problem appears to be the long-acting beta-agonist salmeterol that is one component of Advair.

Asthma, which affects an estimated 25 million Americans, is caused by inflammation and swelling of the airways in the lungs as well as constriction of those airways. Long-acting beta-agonists, or LABAs as they are frequently referenced, which treat airway constriction, which provides symptom relief, while corticosteroids treat inflammation.


But long-acting beta-agonists have been linked to 1,900 asthma deaths from 2004 through 2011, according to an estimate provided by AdverseEvents Inc., a private firm that analyzes drug side effect data reported to the U.S. Food and Drug Administration. Because of the voluntary nature of those adverse event reports, it is likely that estimate is low.

In 2008 a different analysis by a researcher with the U.S. Food and Drug Administration estimated the drugs contributed to 14,000 asthma deaths from 1994 through 2007. Advair, approved in 2000, is by far the biggest seller.

The story of how a potentially dangerous drug became commonly prescribed comes from a Journal Sentinel/MedPage Today review of transcripts of FDA hearings, financial disclosures, medical journal articles, treatment guidelines and a U.S. Department of Justice complaint against GlaxoSmithKline.

Birth of a Blockbuster

Advair was considered a breakthrough in convenience because it combined the GlaxoSmithKline two effective agents, salmeterol to treat airway constriction and the corticosteroid fluticasone to treat inflammation.

Advair and similar drugs are considered appropriate treatment for severe, treatment-refractory asthma that is not controlled by corticosteroid treatment alone. But a 2010 study by Medco Health Solutions found nearly two-thirds of mild asthma patients were taking the combination drug -- often without trying a steroid first.

One theory for why Advair and similar drugs carry increased risk of deadly attacks is that the long-acting beta-agonists may mask worsening inflammation in the lungs. As a result, the patient "feels better" even as the disease worsens, thus setting the stage for a catastrophic asthma exacerbation. Assessing Risk, Risking Safety

In 2010, when the FDA approved more large-scale safety trials of the drugs, some of its own researchers called doing so unethical because it could put tens of thousands of patients at risk, according to a transcript.


Such trials would be especially dangerous for children, agency physician Andrew Mosholder, MD, warned, noting children "can't give consent themselves and one could argue the ethical burden is greater to protect."

The trials, which are not expected to yield results until 2017, will involve 46,800 adults and adolescents aged 12 and older. A separate trial involving 6,200 four- to 11-year-olds also is being conducted.

At a 2008 FDA advisory panel reviewing the use of the drugs, agency physician David Graham, MD, questioned whether it was worth putting an entire population on the drugs just to find that occasional patient who gets better control of their asthma, according to a transcript of the meeting.

"We have no way of identifying who's going to have that miraculous response to Advair," he said, "just as we have no way or predicting who's going to end up in the cemetery because of Advair."

Graham has a long-standing reputation as a FDA whistleblower, who has testified at Congressional hearings investigating the marketing of Merck's arthritis pain drug Vioxx, withdrawn after it was linked to heart attacks, and the diabetes drug Avandia, a GlaxoSmithKline drug, which was linked to increased risk of heart attacks.

FDA spokeswoman Morgan Liscinsky noted in an emailed statement that in 2010, the agency instituted new safety requirements for the drugs, including that they only should be used for the shortest duration necessary to achieve control of symptoms and then discontinued if possible.

In addition, the agency said long-acting beta-agonists should only be used with a steroid. The agency also issued warnings in 2006 about the increased risk of deadly attacks.

Liscinsky said the FDA believes the benefits of the drugs outweigh the risks when they are used properly.

Continue reading,

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From the Nursing Times:

Herbal remedies such as echinacea and St John’s Wort “could make medication dangerous”, the Daily Mail has warned.

The story is based on a large review of evidence that aimed to identify potentially harmful interactions between supplements (herbal and dietary) and conventional medicines.
These types of supplements are increasingly popular, and include:
  • St John’s Wort – used in an attempt to improve mood
  • gingko – used in an attempt to boost energy
  • echinacea – used in an attempt to strengthen the immune system
The study found that the supplements St John’s Wort, magnesium, calcium, iron and gingko had the greatest number of interactions with conventional drugs. The medicines warfarin, insulin and aspirin had the greatest number of interactions with herbal and dietary supplements.
Warfarin was reported to have more harmful interactions than any other drug. Most adverse events – across all supplements and medicines examined – were “moderately severe” and included abdominal problems, seizures and psychiatric disorders.
The herbal products flaxseed, echinacea (often taken for colds) and yohimbe (popular for libido problems) had the largest number of reported ‘contraindications’. A contraindication is where the products should not be used because they are known to interact with conventional medication or they can worsen a pre-existing health condition.
The UK market for herbal and dietary supplements continues to grow, with many people mistakenly viewing them as “natural” and therefore harmless.
Anyone taking conventional medication is advised to speak to their GP or pharmacist before using a herbal or dietary supplement.

---------------------

The researchers found 1,491 different interactions between herbal and dietary supplements and medicines. These involved 213 different supplements and 509 medications.
  • Herbal and dietary supplements containing St John’s Wort, magnesium, calcium, iron and gingko had the greatest number of reported interactions.
  • The drug warfarin (an anti-clotting drug that ‘thins’ the blood) had by far the largest number of reported interactions with supplements (105). This was followed by insulin (41 reported interactions), aspirin (36), digoxin (32) and ticlopidine (23).
  • Medications affecting either the central nervous system or the cardiovascular system were those most commonly associated with interactions.
  • 42.3% of the interactions were due to “altered pharmacokinetics” (the supplement interfered with the absorption or action of the medication in the body).
  • 240 (about 16%) were described as major interactions – that is interactions that posed a potentially significant risk to health, such as triggering excessive bleeding.
  • 152 contraindications to supplements were found. The most frequent of these were gastrointestinal (16.4%), neurological (14.5%) and kidney or genitourinary disease (12.5%).
  • The herbal products flaxseed, echinacea (often taken for colds) and yohimbe (taken for libido problems) had the largest number of reported contraindications
  • Herbal remedies were reported as having more drug interactions and contraindications than dietary supplements.
Read the entire article here.

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From The Los Angeles Times:   
Getting an early diagnosis of dementia could lead to finding ways to cope — and it could mean feeling bereft at what the future holds. So do you want to know?

The early diagnosis of and intervention for Alzheimer’s and other dementia has become an increasing priority, but that means the patients and their informal caregivers are left facing many issues regarding their futures that need to be considered, researchers said Tuesday.
The researchers, from several British universities, reviewed 102 studies from 14 countries to consider the ramifications on patients and caregivers of a dementia diagnosis. They reported their findings in the journal Public Library of Science-Medicine.
Their findings, they said, suggest that research is needed into evaluating interventions after diagnosis. By 2050, more than 115 million people worldwide will be diagnosed with dementia, they noted.
The studies involved 1,145 people with dementia and 1,950 informal caregivers. They lived in 14 countries, though primarily in the United Kingdom and North America. While most of the people were white, the researchers said several studies focused on nonwhite people.
The researchers found three broad themes: barriers to early diagnosis; the impact of the diagnosis; and living with dementia.
Among the barriers to diagnosis was – not surprisingly – the stigma attached to dementia. The researchers said a trigger event, such as a hospitalization, often preceded diagnosis. Relatives often recognized a problem before the patient, the researchers said.
Post-diagnosis, patients had similar problems adjusting to be being a person with dementia – leading to anger, uncertainty and frustration, the researchers said. While many people struggled to preserve aspects of their former selves and relationships, the researchers said most patients and caregivers eventually reached a state of acceptance. Sometimes diagnosis came as a relief, validating suspicions.
Caregivers may be torn between protecting the loved one and promoting his or her independence; often as well the patient and family struggle to maintain the patient’s previous identity while assimilating the new one. Some people seek all the information possible, while others rejected it – feeling there was no point in knowing. “Better knowledge-sharing at the point of diagnosis was not always the solution,” the researchers said.
The researchers said they found “a clear need for great support after diagnosis, including advice, social and psychological support, access to community care and respite.”

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Here's a 2009 article from Yahoo on HMO problems. As many of you know, Jack has a bone to pick (well, several bones actually) with HMO's, and we'll be writing about them from time to time here on the Life Ethics blog. There may be some occasional crossover with the TBI blog if brain injuries and/or mental conditions and HMO's cross paths in the same article. We'll also tell Jack's story in more detail at some point. But for now, let's just take a look at some of the more obvious problems one encounters with HMO's.
If you or anyone you know have had HMO problems, then you can understand how this type of medical insurance tends to send people screaming in the other direction. It may or may not save you money, depending on the problems you come across, and the illness you're trying to get treated. Some of the problems are common and you can get around them, others can be more difficult and cost you more money and time.
For example. Someone I know had a broken jaw. She went to a doctor listed with HMO and had her jaw set and wired together. It was like this for four months. Anyone who's had their jaw wired, knows this is no picnic.
After a month, she started having problems with her jaw. It hurt all the time and from looking at her, you could see the jaw was dropping and not aligned properly. She went back to the doctor, and was told the wire was growing into her gums, her jaw bone was not growing back together like it should, and that she would have to go through more surgery to fix the problem.
But here's the kicker, we discovered the doctor who did the original surgery, had just opened her practice, and had never performed this type of surgery before, and of course did not know how to perform the surgery needed to correct the problem.
So my friend was referred to another doctor who could do the procedure. The problem however is that he was not listed with HMO. The doctor had to go through hoops trying to get HMO to cover the procedure.
They needed proof, documentation and pictures before they would even consider approving her surgery. It took them one month to approve the corrective surgery.  In the end, it took a total of 4 months to get her jaw fixed, fifteen days from work, 25 pounds of lost weight, and more aggravation than you need to go through when you're sick.
The only thing I can fault her for is not checking out the doctor, the way we all should. Being listed with HMO doesn't mean anything, and it surely doesn't mean the doctor knows what they are doing.
So I've listed a few of the problems you could possibly run into with HMO, and how you can avoid them.
Check The List Of Doctors With Your HMO:
See if the HMO list has a decent supply of doctors in each category. Also check for the listings of medical specialists, like oncologists, cardiologists, neurologists, etc. It's better to have more than one doctor to choose from.
Choosing Your HMO Doctor:
HMO is like any other medical plan that exist today. They have a list of doctors you can choose from. Where you go wrong is choosing a doctor you know absolutely nothing about, and not scheduling an appointment with them - so you can ask questions.
Be very polite and ask them about their medical training, and if they have ever done the type of surgery you are scheduled for. If they won't or don't answer you questions, then you should find another doctor.
Even if they answer your questions, it doesn't mean you are going to like the answer. If you don't, find yourself another doctor.
HMOs may be a little reluctant in letting you change doctors, but if you insist, they will eventually agree. It is better to go through this, than using a doctor who you either don't like or can't perform the procedure you need.
Getting A Second Opinion:
Getting a second opinion can be rather tricky. Especially if you were referred to a doctor that happens to be a colleague or friend of your doctor.
If they both belong to your HMO, the second doctor may be rather hesitant to give an honest opinion, because he's afraid of offending his friend or colleague.
What you may need to do is go outside your HMO plan, and find a doctor that has no relationship with your doctor, and has nothing to gain.
You need to check with your HMO to see if they would cover a second opinion from outside the plan. If they don't, you might want to consider doing it on your own, but the money would come out of your pockets.
Continue reading.

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