Fifty Years Ago

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Last night, several friends and I went to see “The Butler.”  The Movie is powerful and painful in its unapologetic portrayal of the racism and, in turn, the discrimination [and all the ugliness that such discrimination entails] that exist(ed) in our country.  The movie, as you may know, focusses mostly on that period of time when the Civil Rights Movement gained momentum and successfully overturned the Jim Crow laws of the South and made integration of the the school systems the law of the land.  Watching what the young people had to endure, those who chose to be at the forefront of the non-violent battle Martin Luther King led, was unbearable.  The amount of courage it required to “break” the “law” and accept whatever consequences this might bring about was deeply moving.

It has been fifty years since Martin Luther King stood on the steps of the Lincoln Memorial and gave his “I Have A Dream” speech.  Although I was only a kid, the significance of the moment and the speech was not lost on me.  I came from a liberal family and my parents took great care to instill in us that all “men” were created equal and that the racism, the apartheid that existed in the U.S. at the time was not to be tolerated.  We even had our own little run in with the nastiness of racism.  We had just recently returned from having lived in the Congo.  My parents had invited a Black colleague over for dinner.  The next morning, we found paint sprayed on our walkway “Behren Go Back to the Congo” (the misspelling of our last name made my parents certain that the sign had been spray painted by our neighbor, but we had no way of proving his culpability.  Another indication that our neighbor was the guilty party was that when we applied to become members of the club around the corner from where we lived, we were denied entry.  Our neighbor sat on the board.)  Certainly these small incidents do not even touch the hatred and discrimination that Blacks confronted at the time, but it did bring home to me just how volatile the question of race was in our country.

It is no secret that Malcolm X felt that Martin Luther King was an “Uncle Tom.”  Malcolm X, another brilliant orator in the cause of freedom of the Black wo/man in our society was considered more radical than Martin Luther King because he preached total separation from the White man.

When I was thirteen, I became very drawn to Malcolm X.  I believe this was right after he had been assassinated and the whites and the media had been portraying him as dangerous because he preached anger and separation.  I wanted to find out why this person was causing such a reaction in [sic:"my"] community.  My research showed that not only did Malcolm X speak “truth,” but also made sense.  Charismatic rather than dangerous would be how I would have described him and do so to this day.  But his stance was more militant than Martin Luther King’s stance.  Malcolm X was not shy in preaching “an eye for an eye, a tooth for a tooth, a life for a life” rhetoric, which is why the white community, ever guilty of its treatment of the Blacks but, oh so not being able to let go of the power it gave them, shuddered in their shoes.**

When an interviewer asked Martin Luther King what he thought of Malcolm X’s accusation of the former’s approach toward the white man, the Reverend King gave a beautiful answer:

In the end, I think our country needed both leaders and both approaches in order to shift the paradigm because, as Malcolm X pointed out in a marvelous speech he gave on the difference between a house slave and a field slave [see below], when things are more comfortable, the human tendency is to sit back and allow things to remain the way they are, even if it undermines the individual adversely affected.

Although in this speech Malcolm X was specifically referring to the Blacks and their relationship with the Whites, I can easily translate this analogy in more general terms to where our country is today in its response to the way big corporations and Wall Street continue to gut our economic base.  I.e., “We still have food on the table, a roof over our head, a means of getting around, sure “they” have more, but that’s the way things are.”  This not to diminish the fact that the racist undertones that plague our country continue to raise their ugly heads.

Maybe this disparity continues to exist because, in spite of the uplifting belief that we had broken the race glass ceiling, so beautifully summarized in a communication individuals were texting, “Rosa sat, so Martin could walk, so Obama could run” the night Barak Obama won the presidency of the United States, that race glass ceiling continues to cover our nation.  Until we truly reflect and try to incorporate the following fact stated by the Reverend Martin Luther King during his “I have a Dream” speech:

“…. many of our white brothers, as evidenced by their presence here today, have come to realize that their destiny is tied up with our destiny.They have come to realize that their freedom is inextricably bound to our freedom. We cannot walk alone [author's emphasis].”       Martin Luther King, “I have a Dream” Speech, August 28th, 1963.

Until we are willing to display the courage that the African American youth did during the Civil Rights movement, until we truly say, “enough!” and mean it with our actions, until we come together in a United state, we will continue to live in a world of discrimination and inequality, whether based on race or wealth.

 

© Yvonne Behrens, M.Ed  2013

** We really do not know how Malcolm X’s position would have evolved over time since he was gunned down before he was able to come into full expression.  We do know that he went on Hajj (the pilgrimage to Mecca and one of the requirements for Muslims) and that the experience profoundly affected his outlook.

 

 

 

 

 

 

Heart Surgeon Comes Clean

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As you may recall, I wrote on two documentaries “Forks Over Knives” and “Chow Down”, both documenting how it is what we eat that affects our health.  Since then, I seem to be coming across more and more articles in which doctors are claiming that health begins with what we eat, not the pills we pop or the surgical procedures we undergo.  This is refreshing and heartening.

Recently, I read a wonderful confession by a Dr. Dwight Lundell, a heart surgeon for over 25 years.  He claims:

I trained for many years with other prominent physicians labelled “opinion makers.” Bombarded with scientific literature, continually attending education seminars, we opinion makers insisted heart disease resulted from the simple fact of elevated blood cholesterol.

The only accepted therapy was prescribing medications to lower cholesterol and a diet that severely restricted fat intake. The latter of course we insisted would lower cholesterol and heart disease. Deviations from these recommendations were considered heresy and could quite possibly result in malpractice.

It Is Not Working!

These recommendations are no longer scientifically or morally defensible. The discovery a few years ago that inflammation in the artery wall is the real cause of heart disease is slowly leading to a paradigm shift in how heart disease and other chronic ailments will be treated.

Dr. Lundell then continues:

The long-established dietary recommendations have created epidemics of obesity and diabetes, the consequences of which dwarf any historical plague in terms of mortality, human suffering and dire economic consequences.

Despite the fact that 25% of the population takes expensive statin medications and despite the fact we have reduced the fat content of our diets, more Americans will die this year of heart disease than ever before.

Statistics from the American Heart Association show that 75 million Americans currently suffer from heart disease, 20 million have diabetes and 57 million have pre-diabetes.

Dr. Lundell then explains chronic inflammation:

…..without inflammation being present in the body, there is no way that cholesterol would accumulate in the wall of the blood vessel and cause heart disease and strokes. Without inflammation, cholesterol would move freely throughout the body as nature intended. It is inflammation that causes cholesterol to become trapped.

Inflammation is not complicated — it is quite simply your body’s natural defence to a foreign invader such as a bacteria, toxin or virus. The cycle of inflammation is perfect in how it protects your body from these bacterial and viral invaders. However, if we chronically expose the body to injury by toxins or foods the human body was never designed to process,a condition occurs called chronic inflammation.

And it is chronic inflammation that causes ill health like heart disease and diabetes.  So what is the cause of chronic inflammation?  Surprise, surprise, according to Dr. Lundell, it is:

… the overload of simple, highly processed carbohydrates (sugar, flour and all the products made from them) and the excess consumption of omega-6 vegetable oils like soybean, corn and sunflower that are found in many processed foods.

Our wise doctor continues:

There is but one answer to quieting inflammation, and that is returning to foods closer to their natural state. To build muscle, eat more protein. Choose carbohydrates that are very complex such as colorful fruits and vegetables. Cut down on or eliminate inflammation- causing omega-6 fats like corn and soybean oil and the processed foods that are made from them.

One tablespoon of corn oil contains 7,280 mg of omega-6; soybean contains 6,940 mg. Instead, use olive oil or butter from grass-fed beef.

Dr. Lundell’s recommendation?

Animal fats contain less than 20% omega-6 and are much less likely to cause inflammation than the supposedly healthy oils labelled polyunsaturated. Forget the “science” that has been drummed into your head for decades. The science that saturated fat alone causes heart disease is non-existent. The science that saturated fat raises blood cholesterol is also very weak. Since we now know that cholesterol is not the cause of heart disease, the concern about saturated fat is even more absurd today.

Three cheers for Dr. Lundell and his honesty.  Thank you, Dr. Lundell.

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A Room With A Grim View: The ‘Ambient Despair’ That Marks Life In Assisted Living

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[Note: I am putting this article in the boomer section of my blog because we are at that stage when we can still do something to instigate change.  But we will only put the time and energy that is required to implement the change if we look at the problem squarely in the face, something our generation does not have the tendency to do.]

I am not a proponent of “retirement” communities although I do understand that certain circumstances do require it.  One might be getting on in years and can no longer do for oneself.  One’s mental or physical self starts to become frail and so one’s needs for assistance might increase.  If one has no family or one’s family lives in another state and one can no longer maintain one’s home, the institutional care is an option.  On a more positive note, “retirement” communities might be a place where one’s recreational and social activities might increase.  And one has the security of knowing that there is 24/hr nursing care.

Our society and the advertisers certainly do everything to encourage us into believing that this is an attractive alternative to staying at home.

One of the more glaring disadvantages of the retirement home is its segregation: the “old” people’s home where n’ery a person under a certain age lives.   Everywhere you turn, you see someone your age or older; except for the bouncy activities coordinator, urging you to participate in musical chairs or something.  Also, as you become more and more frail, the individuals with whom you interact most often are those caring for your daily needs.  These are the individuals within this community who get the least compensation for what they do and so, in turn, are the least constant.  Thus you are continuously being handled by strangers.  And, because of anti-discrimination laws, now there are male CNAs.  Imagine being a frail 90 year old Southern woman (to really make for the extreme case) and having a large African American male CNA enter your room telling you it is time for you to take your shower.  The cultural disconnect that this scenario entails is truly unfortunate and although not necessarily common, has occurred.

Also, for the most part, once one enters a “retirement” community, one’s sense of self starts to become eroded as one confronts choices made for oneself without being involved in the decisions.  This can be children making decisions about their parents and dropping them off at the facility or it can be experienced after arriving at the facility.

I recently read an article by a gentleman, Martin Bayne (mkbayne@alum.mit.edu), who wrote about his own personal experience in such an environment.  He has early onset Parkinson’s disease and so has found himself in a home at slightly a younger age than most.  However, following was one experience he had:

During the first few weeks in my new surroundings, I requested a meeting with the facility’s senior management. I’ve been both a journalist and a Zen monk in my day, making me someone who likes to make sure we all understand one another and communicate well.

The three executives and I met in my room, and the meeting soon turned fractious. I don’t remember exactly what the chair of the housing board said, but I challenged it. “That’s not fair,” I told him. “You get to go home every day at five o’clock, but this is my home.” He stood up, pointed his finger at me, and roared, “This is NOT your home. You just lease an apartment here like everybody else.”

I realized right then that the residents of “their” assisted living facility, among whom I now numbered, didn’t have a voice. Those of us there, and in many other such facilities, arrive in this, our new society, alone, possibly ill, often without the comfort and support of a spouse we’d been married to for decades.

Besides having one’s ability to make decisions or play an active role in the decision making process of one’s environment removed, you enter into an environment where more than likely you do not know anyone.  More eerily, although no one knows each other, everyone recognizes that this is the last stop, so to speak.  Both of these factors have got to take their toll on one’s psyche.  Mr. Bayne chose to move into a facility, knowing that those surrounding him would be much older than he.  Again, quoting Mr. Bayne:

  1. People my age—I’m now sixty-two—might go to an assisted living facility every now and then to visit an older family member. Facilitated aging is a way of life for a growing number of Americans, more than one million of whom now live in roughly 40,000 such facilities across the country.

But few people in my age group actually live in an assisted living facility. I do.

Eight years ago, while still in my fifties, in a wheelchair and after nearly a decade of living at home with young-onset Parkinson’s disease, I decided to move into an assisted living facility. I knew what my decision meant. I’d be moving into a place where the average resident was thirty-two years older than I was, and the average levels of disability, depression, dementia, and death were dramatically higher than those in the general population.

What I hadn’t calculated, however, was what it’s like to watch a friend—someone you’ve eaten breakfast with every morning for several years—waste away and die. And just as you’re recovering from that friend’s death, another friend begins to waste away. I can say with certainty that the prospect of watching dozens (at my young age, perhaps hundreds), of my friends and neighbors in assisted living die is a sadness beyond words.

Mr. Bayne continues with the saddest part of his evaluation:
We eat meals in a dining room filled with strangers and, for perhaps the first time in a half-century, sleep alone in an unfamiliar bed. We then usually find ourselves silenced by, and subjected to, a top-down management team whose initial goal seems to be to strip us of our autonomy. And it is in this environment that most of us will die.

Most residents in assisted living facilities, by necessity, live secret lives. On the outside, there might be a calm, even peaceful veneer. But beneath the surface, all of us are susceptible to the ambient despair that is a permanent component of life in this type of facility.

This despair is as real as the landscaping or the food—only more deeply and widely prevalent. It’s the result of months or years of loneliness and isolation and of a lack of true social interaction among residents. It’s also the result of burying our feelings and emotions about the exceptionally high numbers of demented and disabled neighbors around us and being surrounded by frequent death.

To read more of Mr. Bayne’s article about his experiences in an assisted living facility, please go to

1Martin Bayne (mkbayne@alum.mit.edu) is an advocate, author, and publisher who lives in an assisted living facility in Center Valley, Pennsylvania.

But Mr. Bayne doesn’t stop at just describing the realities of living in an Assisted Living Facility.  He wants to try and change the realities of assisted living life.  And so he continues:

Living with Parkinson’s disease has led me to realize that the quality of my life depends on the future viability of the long-term care system in the United States. So, too, does the quality of life for the millions who are similarly situated—the chronically ill, disabled, frail, and elderly individuals who are unable to accomplish those defined activities of daily living. We need better, more humane places to live in that allow us to preserve whatever health and happiness we have left. We also need to be surrounded with more compassionate, higher-quality, yet still affordable care.

To create genuine long-term care reform, we as a nation need to perform a series of activities. We must understand the full nature and scope of the problem, including knowing the benefits that are and aren’t available under skilled, custodial, and intermediate long-term care. We have to acknowledge the full range of policy options that exist and create a workable way to finance care using a mix of public- and private-sector support. People will also have to acknowledge their personal responsibility for leading purposeful lives, a part of which means considering the costs of long-term care and planning ahead for how to pay for them. In short, we must all be held accountable for ourselves and for the whole.

Until the totality of that approach is under way, we’re in trouble. I’m tackling the part that I can. Difficult as it sometimes is, I’m actively trying to be accountable for myself, my fellow residents, and everyone who lives in assisted living facilities.

Earlier this year, I became the publisher—Paul Soderberg in Arizona is the editor—of the first literary journal to showcase the work of people in their sixties and older. Published online and without charge, it’s named The Feathered Flounder. You can read a copy at http://thefeatheredflounder.com. As I explained in my first publisher’s note, the literary journal “is born in the imagination of those with the benefit of having accepted the unexpectedness of aging…. It is the nature of creativity.”

I hope others—especially policy makers—also will call on the nature of creativity as they wrestle with the realities of assisted living facilities and of aging in general. I’ll keep doing what I can: being active in my community, publishing, and writing about the view from my wheelchair from inside an assisted living facility. Others need to go about tackling the systemic and looming issues for an aging nation.

I applaud Mr. Bayne’s initiative.  He is still at an age when he can work for change, unlike many of those with whom he shares a space.  The fact that he is trying is commendable.  Hopefully, we will all do our part.

© Yvonne Behrens, M.Ed  2013

 

 

 

A Story About Our Medical System

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I have to get my decks power washed and stained.  The man who is doing the job, very nice, friendly, talkative, shared the fact that last year, he had a major heart attack.  I asked if I could share his story and this is it:

“I am 42 years old.  Now I don’t like doctors and I don’t like hospitals.  So something has to feel really wrong for me to even consider either.  I was working on a job, it was around Christmas last year, three days before Christmas to be exact.  I started to feel pretty terrible.  I had been having some chest pains on and off, but, you know, you don’t really think that it might be a heart attack.  Heck, I’m only 42 years old, so….But that day, I was really feeling a lot of pain.  I decided to go home.  I called my wife and told her that she needed to call an ambulance.  When I got home, the ambulance had not arrived yet.  She gave me aspirin.  It was winter.  It was cold.  They came and I told them that I thought I was having a heart attack.  They looked at me and replied, “Nah. Can’t be.  You are too young.  You are still standing up.  We’ll take your blood count.”  Apparently the blood counts were off the charts, causing the orderlies to jump into high gear.

They told “Jack” to get into the ambulance.  They had called ahead for a helicopter to come to the local hospital because his counts were so high.  They had called the destination hospital, alerting that this patient needed immediate attention.  By this time, “Jack” was shaking with cold.  The orderlies told him they would keep him warm in the ambulance.   “I kept grabbing at more and more blankets.  I just could not warm up.”

Off he went in the helicopter.  Yet when he arrived at the destination hospital, he ended up waiting up to two and a half hours before he went into surgery.  His wife, who drove home from the local hospital to get supplies (they had a baby), arrived forty five minutes after her husband did and helped finish the check in.   He had still not been seen by a doctor.

It turned out that one of the arteries was blocked 95%.  They put a stint in.  The next day, he was ravenous and ready to leave the hospital.  They only provided a menu for a heart patient, which, as one can imagine, was pretty light fare.  ”I told them that I needed to eat something and if they were not going to feed me, I would get up and leave and go get some real food.”  The doctor relented and he was able to eat a hearty (no pun intended) breakfast.

“I really wanted to spend Christmas at home with my family.  The doctors told me, ‘absolutely not!  You need to heal from the surgery.’  I replied that the way I was going to heal was to be with my family.  Thankfully, they did release me on Christmas day.”

He was given a slew of medications to take, including blood thinners and Statins.  He was supposed to go back for a re-check three months after the surgery.  ”I missed that appointment, but finally got back last week.  They found that my heart had recovered 99% of its abilities.  They were totally amazed since they said  this was very unusual.  But they also told me that my cholesterol was still too high and so they put me on a stronger Statin, Lipitor.”

Apparently, they are suggesting that he only do this for a year.  They will re-test in December to see whether he needs to continue.

Jack continued: “The doctor gave me a coupon for one of the  medications.  This medication costs $280 a bottle and the doctor told me, what with the fact that I work for myself, that if this was too cost-prohibitive, he would write me a prescription for a different medication.  Turned out that bottle cost $18.  I chose the medication that cost $18.”

“Now I’m not saying I am hundred percent and I don’t feel like I used to.  I have made some adjustments and I have slowed down, but I wonder where I would be had I not taken some initiative.”

One could say that “Jack” is a miracle story.  One could even conclude that had he not been tended at the hospital, he might not have been telling me his story.  On the other hand, where would “Jack” be if he had stayed in the hospital, under doctor’s advisement, eating “heart-healthy” meals for X amount of days?  What about the fact that there are two drugs out there that apparently have the same effects: one for $280 and the other for $18, and why did the doctor not suggest the latter in the first place?  And as for Lipitor, “don’t get me started!” [a bow to Billy Chrystal]  The side effects of this drug should be enough to prevent anyone from even considering ingesting this bit of poison.  But most people who are given it, take it, no questions asked.  Why?  The label says: potential side effects.

In conclusion…Some of the story shows our medical system at its best and some of the story shows areas that our medical system needs an overhaul.

Staying Put

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When I was in my late teens, I couldn’t wait to set out on my own.  I [erroneously] believed that I would “find” myself “out there.”  This idea seemed to prevail with “my” generation.   A large number of us ended up in college, totally clueless as to how to approach the next chapter in our lives.  In fact, probably to cover our feelings of insecurity, we developed an attitude towards those of our classmates who seemed to have an idea of where they wanted to go.

Apparently, according to a recent article in AARP, this trend towards setting out on one’s own was extremely common among boomers.  Furthermore, that trend has undergone a shift in the opposite direction with youths wishing to remain in their family home.  According to the AARP article, boomers have developed closer relations with their children than their parents had with them.

I can relate to this.  In my family, my parents lived in their world and we lived in ours.  Sometimes the paths crossed, usually around a behavioral infraction on our part.  Other areas where our paths crossed: attending church together, Sunday meals, “hanging out” together on a Sunday afternoon.  When we were younger, our father played with us on those Sunday afternoons.  As we got older, the hanging out took more of an “us sitting with our parents as ‘they’ relaxed waiting until we could excuse ourselves to go play with our friends.”  Did I ever consider speaking to either of my parents about my personal questions, fears, ideas, inspirations?  No.  Now I cannot speak for all my siblings.  My older sister once opined that she looked at our mother as her best friend.  So I have to assume that she felt totally comfortable sharing everything with my mother.  This, however, did not seem to have an effect on her decision to move out and onward.  In fact, we were expected to do so.

Not so children of boomers.  They enjoy being home, have no strong desire to move far away, feel a connection with their parents.  We always talk about the pendulum swinging one way and then swinging in the opposite direction.  This may be what is reflected, although, according to the article, boomers seem to have made more of an effort to interact with their children, in some extreme cases, treating them as equals or even their superiors.  And, of course, now all the pundits are wondering whether this trend of staying at home is “healthy.”

Since the beginning of the human race, families mostly remained together.  Of course, the restlessness of seeking the new does seem to be an inherent quality in human beings and thus there are many examples of individuals setting out.  Much of the mobility inherent in the definition of our society most probably has to do with the fact that we were the “New World”, a world yet to be fully explored.  It was because the United States was “the new world” which needed to be explored and “tamed” that this trend to separate out and move away was such a dominant feature of the American profile.  Now that our identity is starting to congeal, the restlessness of seeking something different seems to have tapered off.  Although many also look at the economy as a source of this trend.  Oh, and then there is technology in the form of television and computers…..where one can travel a thousand miles away and never leave the living room.

© Yvonne Behrens, M.Ed  2013

 

An Article About a Drug Recall

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Recently, I came across the following article (see below).  Since it contains any and all the elements I might point out had I written the article or even just quoted parts of this article, I am inserting the whole article, with an occasional comment of my own.

David Maris, author of the following article which first appeared in Forbes Magazine:

Pay attention, as I can’t say this seriously enough. Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also [my emphasis]. With this generic, American consumers became the FDA’s guinea pigs to see if the FDA’s assumption was right. It wasn’t.

Background

In December 2006, the first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA.  The drug comes in two dosage strengths, 150 milligrams and 300mg. The 300mg dose is generally used for patients with more severe depression and anxiety and patients who don’t respond to the lower dose.  The FDA approved generic versions of both dosage strengths from a few generic drug companies: Teva Pharmaceuticals (manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals), Anchen, Actavis, Watson Pharmaceuticals and Mylan MYL -0.95% Pharmaceuticals.  Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.

The People’s Pharmacy, a well-known syndicated radio and newspaper columnist husband and wife team, notified the FDA that hundreds of patients had logged their own complaints of side effects with the then-recently approved generic version of Wellbutrin XL. The FDA brushed off the People’s Pharmacy and others that raised the issue, stating that they had faith that the drugs were equivalent and that perhaps the patients, who had mental disease, were more prone to perceived problems with a change in the medication than others. This was seen by many as essentially telling patients “it’s all in their head.” [my emphasis added].   After several more years and public outcry, the FDA was forced to take action.

What Action Did The FDA Take?

Instead of doing its own study on the drug, the FDA asked the drug maker to conduct a study to determine whether the generic drug was equivalent to the brand. [my emphasis added and I will also add that asking the makers of a drug to conduct their own study might smack a little of conflict of interest. This also brings up a point that was made in the movie "Chow Down" that the FDA is not as independent a regulatory body as we are led to believe and their relationship with the food and drug industries are a lot closer than their relationship with the American people.] The FDA, in their recent press release, claims that Teva started the trial but later abandoned it because of slow patient enrollment. It was already 2010, several years after knowing there was a problem, the FDA was forced to do its own study.

Did The FDA Drag Its Heels?

The FDA study was completed in August 2012 – more than 5 years after the initial problems were reported. The FDA study showed that the 300mg dose from Teva is ineffective insomuch as it did not deliver enough of the drug.

Oddly, despite the result being available in August 2012, the public was only made aware of this in October 2012.

How Did This Happen?

When the FDA issued its press release on October 3rd, it said that the FDA made a mistake in that it had taken the data for the 150mg version.  Since that dosage had worked fine, the FDA just assumed that the 300mg dosage would work.  I am not joking – they indicated that this case caused them to change the way they do things.  They approved the drugs by extrapolating the data for the 150mg, assuming the 300mg works the same.

Clearly, the FDA has serious doubts on how they approved the 300mg dosages by just assuming if the 150mg works then the 300mg must work also. The FDA’s press release makes that clear:

FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product.

FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.

This cleverly worded press release hides the fact that this method of approving Wellbutrin XL or any drug is not only “no longer” appropriate, but was never an appropriate way of approving drugs.  Just extrapolating data is an erroneous assumption and ignores basic principles known by most high school science students. In addition, if you don’t test the larger dosages, what if drug companies simply submitted 300mg drugs that had no drug in them?  That seems like more than just a moronic mistake, but a dangerous approach to approving drugs.

But What About The Other Generics The FDA Approved?

Instead of immediately pulling the drugs that were approved with the same faulty approach and instead of the FDA doing their own bioequivalence studies, the FDA has asked the other generic drug companies to do these tests for the FDA and submit these results by March 2013.  The idea of a regulatory agency turning over the testing process of a drug to the drug companies when there is doubt about their safety and efficacy seems like it is giving up its role of independent oversight of the companies it has regulatory power over. [my emphasis]

It seems more appropriate that the FDA conduct these tests and, since the safe brand drug remains on the market, to immediately remove the other generics while we await the results of the testing. [I totally agree with the author's conclusion]

The FDA has long been a strong proponent of generic drugs, and generics have saved consumers and the federal government billions of dollars vs. brand-name drugs.  Many consumers incorrectly believe that a brand drug is identical to the generic drug, and even the FDA on its website calls generics “identical.”  Generic drug companies are subject to FDA inspections just like their name brand counterparts, but the drugs themselves do not need to be identical to the brands; they need to be “bioequivalent” and are given leeway on how close to the brand they need to be.   To me, it’s similar to how Cheerios are almost like the store brand of toasted oat cereal – “Cheery-O’s” – very similar, but not the same.  Roughly speaking, “bioequivalent” means they need to show that the drug releases an active ingredient in nearly the same, but not exact, concentration as the brand.

The whole system works if the generics are bioequivalent, and to ensure that they are, most consumers believe that the FDA would test to see if the generics being considered for approval work as promised.  It appears that many approved generic drug versions have not even been subject to independent FDA studies. [my emphasis]

But how could the FDA know if a drug is bioequivalent if it doesn’t even test it?  It can’t.

How This is A Safety Issue

The lack of efficacy for a high dose anti-depressant is really a safety issue, not a manufacturing issue.

How many patients who were not adequately treated on the 150mg dose were put on the 300mg only to see their symptoms get worse because the generic did not work as promised?  How many patients, doctors, and their families thought that this was simply a further deterioration of a patient’s condition and mental state? How many parents had to worry about their children when their anti-depressant seemed to stop working?  How many people committed suicide taking a generic antidepressant that did not work?

And the appalling part of all this is that the fact that this could have been prevented if the FDA had simply tested the drug before they approved it, or at the least heeded the hundreds of complaints.

8 Immediate Steps That Should Be Taken

Here are eight steps that should be taken immediately to address this crisis and the underlying issues that caused it:

  1. The FDA should immediately suspend approvals for generics Wellbutrin XL and advise doctors via a Dear Doctor Letter to switch to the brand. Pending confirmatory studies, suspend approvals of the other generics.  It is clear if the FDA is asking manufacturers to do new studies on these drugs, it does not 100% trust its effectiveness and safety.  The FDA should not keep drugs on the market where it cannot stand by the efficacy and safety of the drug when the brand is readily available
  2. The FDA should conduct their own study of the bioequivalence of the other generic Wellbutrin XL it approved and not rely on the drug makers.
  3. The FDA should immediately conduct a review of all generic drug approvals in this class and others to determine what other approvals were made with the same faulty approach of assuming that if one dose worked then the higher dose or lower dose must work the same.  Since the FDA has now abandoned this faulty procedure because it resulted in ineffective drugs being put on the market, then it should re-review all these previous approvals.
  4. The FDA should conduct a thorough study of how the vigilance system of early warnings and warnings from others such as the People’s Pharmacy went unheeded for more than 5 years.
  5. The FDA should undertake the difficult but important step of researching which patients took the 300mg generic, which ones may have attempted or committed suicide while on the 300mg or shortly after being switch from the ineffective. Research how many institutionalized patients are on the 300mg dose – advise they are switched to the brand immediately.  The families of these patients should know why the drugs they trusted to work didn’t.
  6. The FDA should tighten the regulations for bioequivalence for narrow therapeutic window drugs, especially those that pharmacists and patients have already complained about not working.
  7. The FDA should provide consumers with the timeline and all correspondence and phone records surrounding this case to show why a two month delay would take place from knowing the drug did not work to telling the public.
  8. Congress should convene an oversight committee on how this happened and what it means for drug safety. Was there anyone at the FDA during this or previously that had issue with the “if the 150mg works, then assume the 300mg works too” approach?

The FDA Commissioner Peggy Hamburg needs to answer for this.  When you keep score by loved ones’ worry and by patient lives cut short by suicide, this is not just the tale of a simple recall, but of a failure of the system and sign of dangerous incompetence.

 

Note: An earlier version of this posting identified the recalled product as being from Teva Pharmaceuticals.  For greater clarification, we have noted that the generic drug subject to the FDA action is manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals

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No part of this article is intended to be investment advice nor should it be considered investment advice.  For disclosure purposes, at the time of this writing, I own shares of Teva Pharmaceuticals.

 

Nothing more need be added to this nicely presented article.

 

Changing One’s Living Situation

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When it was clear that my father could no longer live alone, I found myself, by virtue of being the child who lived closest to him, in the position of having to  encourage him to consider living in a retirement facility.  At first he was resistant.  He did not want to live with a bunch of strangers, eating in an institutional dining room.  The way I talked him into considering it was to compare it to living in a college dorm. “Dad, you did this when you were attending college.  It is the same concept.”

Just recently, I read an article about a new trend among aging single women.  Four or five ban together à la Golden Girls in a group house.  More than any previous generation, boomers are single, either because they never married, they are divorced, they are part of the LGBT grouping, or they are widowed.  A larger number of aging people are women (57 percent make up the grouping 65 and older and 67 percent make up the group of 85 and older).

I know several women who share a home.  It is not always as easy as it may seem.  My friends told me that when they first moved in together, they all went about their own business.  They did not even sit down to dinner together.  But then one of the women needed to take care of her father and the household opted to allow him to move in with her.  This decision made their house become a home, as they all found themselves pitching in to help.  Although the father has since passed away, the pattern of doing things together within the household has remained.  And the women are very happy about this.

One structure that makes a marriage a marriage and a family a family is sharing meals.  Another structure is that everyone in the household pitches in to maintain the home.  Having and/or developing mutual interests also makes up a structure of a family.  These factors would seem important in the formation of a group home.

I like the idea.  I sit here in a house that has become too large for me — too empty.  I like the socialization that comes with sitting around a dinner table.  I always enjoyed doing things with my husband.  Presently, upkeep of home keeps me fairly busy.  It would be nice to share those tasks with someone else. Although I keep busy with many different projects and have an active social life,  coming home to someone has a very different feel.

Of course, one does have to consider that illness may settle on one or two or maybe even three of the housemates and then what happens?  Another thing to reflect on is that different people have different approaches to or definitions of cleanliness.  When in college, one’s sense of cleanliness may have been a little less stringent.  One might be a little more impatient with someone else’s habits when in their ’50′s or ’60′s than they were at eighteen or twenty-one.

However,  I do like the creative way that boomers are looking at the question of housing and how they want to spend their older years and I look forward to reading more about these innovative approaches towards aging.

© Yvonne Behrens, M.Ed  2013

Abraxane™ The New Marketable Cancer Cure

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The parent of someone close to me was diagnosed with Pancreatic Cancer last fall.  At first, the parent, citing her age, determined that she would not do chemotherapy.  Her husband, older than she, became very upset.  So she agreed to see an Oncologist.  The Oncologist, a young, energetic, positive individual suggested that the parent do chemotherapy to shrink the cancer and when it was small enough, surgery could be done and the cancer removed.

Thus, the parent entered the medical system.  She was to do chemotherapy for five months and then be scheduled to have surgery.  Fortunately, side effects to the chemo were not so intense that she could not continue to maintain her day to day activities.  She did loose her hair.

Somewhere along the way, those she was relying on for medical care, decided they would not try to do surgery, yet.  Instead, they suggested that she add a new drug, Abraxane ™,  to the chemo regimen.  This is a new drug that claims to improve the chances of survival for a person with Pancreatic Cancer.

According to an article in MNT (Medical News Today):

Results from the study revealed that 35% people on the combination of Abraxane™ and chemotherapy were alive at the end of the first year compared to only 22% who just underwent chemotherapy. This translates into a 59% increase in one-year survival as well as double the rate of survival in two years for the patients on Abraxane™ versus those who only received the chemotherapy. Those who were solely on chemotherapy survived for only 6.7 months compared to a median of 8.5 months among those who also took Abraxane™.

Breaking this paragraph down, I see a claim that somehow the percentage of people alive at the end of the first year who were taking a combination of Abraxane™ and chemotherapy was 35% as compared to only 22% of people alive after a year of taking just chemotherapy.  Those percentages are not very high.  But through the magic of playing around with numbers, this 13% differential “translates into a 59% increase in one-year survival”  Sounds phenomenal!  But is it really?  Not only that, but if we take these numbers, as the researchers have done (there is no indication that there were any tests done to actually prove this to be fact), this doubles the survival rate in two years.  Hunh?

The last line in the paragraph totally contradicts the claims above it by stating that (without qualifiers) those using solely chemotherapy “only survived 6.7 months” and those who did chemo in combination with Abraxane™ survived “a median of 8.5 months.”  Hard to imagine all those individuals who had Pancreatic Cancer and were solely doing chemotherapy keeling over at 6.7 months from start of chemo regimen.  Even if this were the case, the claims that adding Abraxane™ to the chemotherapy increases survival rates by an amount that is exciting seem a bit exaggerated if the median survival rate with this addition is only 8.5 months.

I would not be so offended by all of this if it in fact reflected an industry desperately wanting to find a cure for cancer and dedicating all their waking hours to that end.  BUT, unfortunately, the facts do not demonstrate this.  What the facts demonstrate is that this new drug,  a bit short on its healing claims, is doing incredibly well in the area of generating income.  From the same article:

Abraxane™ made sales of close to $386 million in 2011 for it’s use as breast cancer treatment. It is expected to generate close to $2.1 billion as a treatment for pancreatic cancer. Abraxis BioScience was the original company to develop the drug, they were bought out by Celegene in 2010 for $2.9 billion. Celegene can expect to see good sales of the drug [emphasis by author], although it might see strong competition from the drug Folfirinox™ which was found to similarly improve survival among pancreatic cancer patients.

In the meanwhile, debilitating side effects have increased quite a bit in our 89 year old patient since the incorporation of Abraxane™ into her chemotherapy regimen.

© Yvonne Behrens, M.Ed  2013

 

 

 

 

Chow Down

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“Americans are sick.  Over 130 million [author's emphasis] are suffering from chronic disease.” So begins the documentary, Chow Down** a film by Julia Grayer and Gage Johnston, The film is tightly put together and does an excellent job of presenting a sobering view of the state of eating in our country. It focuses on the eating habits of Americans today, the influences which direct those eating habits, and more specifically, on the lives of three individuals who were told that unless they radically changed their approach to eating, they would die.  Grayer and Johnston do not gloss over the fact that it is not so easy to change one’s eating habits even if it means potentially saving one’s life.

Charles, a man “who has it all,” including heart disease, has a very supportive wife and because of this, the whole family has changed their eating habits.  Charles speaks about how as an Italian, whose grandfather owned a meat shop, large meals with lots of meat were a big part of life’s enjoyment.  Yet he and his family have made the adjustment, to the point of bringing their own food when they take trips.  (May Charles live to watch his grandchildren grow up and may he and his wife grow old together).

Two other individuals who are also working at changing their diets were interviewed.  One interviewee lamented that he missed his Kentucky Fried Chicken™  The other spoke about how difficult it was to maintain a more plant-based diet when the rest of her family was not.

And yet the medical profession does not focus on nutrition and diet when interacting with patients, but rather pills and surgery.  Dr. Esselstyn, a former heart surgeon at the Cleveland Clinic and one of the interviewees in both Forks Over Knives and Chow Down, learned through his practice that there was a direct relationship between diet and heart disease.  He says that surgery does not prevent the disease.  He states that the medical industry is “… selling sickness right now.  We are selling sickness as a profession.  You don’t get health out of a bottle of pills.  You don’t get health out of a bunch of operative procedures.  I know that as a former surgeon.”

Another interviewee in Chow Down, Neal Barnard, MD, shares that ” the most popular pill on the market today is Lipitor ™ ….a pill created to curb the effects of dietary excess.”

According to the www.chowdownmovie.com home page,

…. three factors …. fatally impact our country’s health: the medical community’s allegiance to the status quo, the government’s allegiance to the food industry, and Americans’ allegiance to cheap, convenient food.

Grayner and Johnson, through very tight interviews with key players in the medical industry, the food industry, and the government demonstrate how, at least at this stage in time, we, as consumers, are controlled by the relationship between the food industries, the government and the medical community.

Dr. Barnard points out that the USDA has two mandates.  One is to promote health and the other is to promote American agricultural products.  This could certainly become a potential conflict of interest, particularly since the Federal Government participates in creating generic advertising for certain products (Got Milk? for example) from a fund that they administer but which is provided by the food industry.  In fact, the federal government even has worked with the fast food industry to help them advertise foods that include cheese, not because the foods are healthier but to promote the dairy industry.

Even the food pyramid, which has undergone many changes in recent years, is influenced by the needs of the Agro-business.  One outcome is that we have come to believe that certain foods are more important than others, ie, meat rather than lentils, both sources of protein.  Yet studies have shown that a primarily meat based diet can be harmful to one’s health.  [Whether it is the meat itself or whether it is all the additives that farmers put into their livestock is a topic for further research and another article].

At one point in the documentary, Grayer and Johnson interview Louise Light, a nutritionist who was hired by the USDA in the late ’70′s to come up with a food pyramid.  She and a team of experts had concluded that fruits and vegetables were the most important foods to eat, but when their pyramid came back from the Secretary’s office, it had been revised, emphasizing grains as the most important food.  Apparently, when the meat industry heard about this, they put the pressure on for meats to be better represented. [Recently the food pyramid has undergone a further transformation to MyPlate].

During her tenure at the USDA, Ms. Light had created a nutrition course for the Red Cross.  In the course, she cited several foods that had direct links to cancer.  She states that she was approached by a representative from one of those food industries who offered her $60,000 to drop the word cancer from her coursework.

I applaud Ms. Grayner and Ms. Johnson’s superb documentary.  As more and more information comes out about how our eating habits greatly influence our health, we might just be able to change the course that the food industry has taken in our country.

(As I was “going to press” I came across this link, which I think reflects how the movement for eating right is starting to take off http://www.upworthy.com/i-m-sick-of-rich-people-telling-me-how-to-spend-my-money-but-i-think-this-guy-is?c=ufb1

© Yvonne Behrens, M.Ed  2013

** Following my write up on the documentary Forks Over Knives, I received an e-mail from Julia Grayer, a filmmaker, who along with Gage Johnston, wrote, directed, and produced Chow Down.

 

 

Our Expensive Health Care System

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The other day, I was reading an entry by Ronni Bennett in her blog posts in which she reviews an article entitled:  Bitter Pill: Why Medical Bills are Killing Us,  a report written by Steve Brill, the founder of Court TV and American Lawyer.  Shortly after reading her review of the article, I came across several other reviews of the same article.  I am very happy that this topic is beginning to be looked at.  I have written on the topic of expensive health care.

Although Ms.Bennett had some issues with Mr. Brill, she states:

Nevertheless, “Bitter Pill” is the best damned report about the sorry state of the U.S. Health care industry I’ve ever seen (and I read a LOT about health care).

What makes it so good is its clarity. It is filled with case and interview details, comparisons among costs, charges and profits, and written not for lawyers, doctors or policy wonks with the intention to obfuscate, but for you and me, the average reader.

Plus, it reads like a good novel in the sense that you can’t wait to get to the next paragraph, the next page. By the end, Brill shows what we old folks already know – that in health care delivery and in cost control, Medicare beats private coverage every time.

Brill’s conclusions about what to do to rein in health care costs appear to me to be weak but I want to spend more time considering them. What’s important, however, is that he gives us plenty of information to use as a basis for an honest, public conversation about how to change American health care.

Not that I’m holding my breath given the power of the medical industry lobby.

from the article, Ms. Bennett shares some interesting statistics.  According to Mr. Brill:

we spend more on health care than the next 10 biggest spenders combined: Japan, Germany, France, China, the U.K., Italy, Canada, Brazil, Spain and Australia.

We may be shocked at the $60 billion price tag for cleaning up after Hurricane Sandy. We spent almost that much last week on health care.

Medicare pays $11.02 for a CBC [complete blood count] in Connecticut. Hospital finance people argue vehemently that Medicare doesn’t pay enough and that they lose as much as 10% on an average Medicare patient…..But even if the Medicare price should be, say, 10% higher, it’s a long way from $11.02 plus 10% to $157.61.” [which the hospital charges for the same test.]

In 2008, Gregory Demske, an assistant inspector general at the Department of Health and Human Services, told a Senate committee that ‘physicians routinely receive substantial compensation from medical-device companies through stock options, royalty agreements, consulting agreements, research grants and fellowships.’”

MD Anderson’s charge of $7 each for “ALCOHOL PREP PAD.” This is a little square of cotton used to apply alcohol to an injection. A box of 200 can be bought online for $1.91.”

”More than $280 billion will be spent this year on prescription drugs in the U.S. If we paid what other countries did for the same products, we would save about $94 billion a year.”

Ms. Bennett concludes:

Brill’s report reinforces more vividly what others before him have shown many times over – that what is wrong with our health care system is not Medicare, it’s the private sector.

When I googled Steve Brill’s article, there were pages and pages of respondents from around the United States.  Most seemed to support the contents of Mr. Brill’s article.  Although I have as yet to read it myself, I do look forward to it.   I quote Ms. Bennett’s response to the article because in reading her reflections on Mr. Brill’s article, they  reflected my concerns about our healthcare system.

© Yvonne Behrens, M.Ed  2013