1946, The First Year of the Baby Boom

As a boomer, I have decided that I am going to post events that happened every year from 1946-1964, the years that have been coined the Baby Boomer Years.  Each new post will take the next year up until the last year of the boomer years.

As it turns out, 1946 was an incredibly crucial year in which many events formed or helped create scenarios which have continued to be the backdrop of the world that we Boomers have lived in.  As a few: the Cold War and the CIA came into existence; the first computer was completed; the Zionist were making forays into creating a Jewish state in Palestine; the Nuclear weapons race begins; the United Nations was created; Ho Chi Minh and Vietnam entered the world stage; many new governments were created and a very definite line was drawn between the Eastern and Western blocs; many colonies were demanding their freedom, some of which were granted in 1946.  Television as a source of entertainment began; the issues of racism start to be acknowledged politically in the United States; the NFL is formed; the first commercially designed helicopter is introduced; the bikini bathing suit is introduced; the first Cannes Film Festival is held; Nehru forms a government in India; George Orwell publishes “Animal Farm”; Dr. Spock publishes his book on rearing babies, the bible used to bring all us boomers up.

Domestically,

President Harry Truman was President of the United States.  Within the country, much upheaval and change was being felt.  According to Wikipedia:

The end of World War II was followed by an uneasy transition from war to a peacetime economy. The costs of the war effort were enormous, and Truman was intent on decreasing government expenditures on the military as quickly as possible. Demobilizing the military and reducing the size of the various services was a cost-saving priority. The effect of demobilization on the economy was unknown, but fears existed that the nation would slide back into a depression. A great deal of work had to be done to plan how best to transition to peacetime production of goods while avoiding mass unemployment for returning veterans. There was no consensus among government officials as to what economic course the postwar U.S. should steer. In addition, Roosevelt had not paid attention to Congress in his final years, and Truman faced a body where a combination of Republicans and conservative southern Democrats formed a powerful voting bloc.[68]

The president was faced with the reawakening of labor-management conflicts that had lain dormant during the war years, severe shortages in housing and consumer products, and widespread dissatisfaction with inflation, which at one point hit 6% in a single month.[69] Added to this polarized environment was a wave of destabilizing strikes in major industries, and Truman’s response to them was generally seen as ineffective.[69] A rapid increase in costs was fueled by the release of price controls on most items, and labor sought wage increases. A serious steel strike in January 1946 involving 800,000 workers—the largest in the nation’s history—was followed by a coal strike in April and a rail strike in May. The public was angry, with a majority in polls favoring a ban on strikes by public service workers and a year’s moratorium on labor actions. Truman proposed legislation to draft striking workers into the Armed Forces, and in a dramatic personal appearance before Congress, was able to announce settlement of the rail strike. His proposal passed the House of Representatives, but failed in the Senate.[70][71]For commodities where price controls remained, producers were often unwilling to sell at artificially low prices: Farmers refused to sell grain for months in 1945 and 1946 until payments were significantly increased, even though grain was desperately needed, not only for domestic use, but to stave off starvation in Europe.[72]

Although labor strife was muted after the settlement of the railway strike, it continued through Truman’s presidency. The President’s approval rating dropped from 82% in the polls in January 1946 to 52% by June.[73] This dissatisfaction with the Truman administration’s policies led to large Democratic losses in the 1946 midterm elections, when Republicans took control of Congress for the first time since 1930. The 80th Congress included Republican freshmen who would become prominent in the years to come, including Wisconsin Senator Joe McCarthy and California Congressman Richard Nixon. When Truman dropped to 32% in the polls, Democratic Arkansas Senator William Fulbright suggested that Truman resign; the President in response indicated that he did not care what Senator “Halfbright” said.[74][75]

When I was looking at what was happening in 1946, I was a little surprised at how familiar many of the entries sounded to our world today.  I did leave out a lot of references to sport events, Broadway events, and music premiers, since, although influences, I was wanting to focus more on events that caused major changes in our outlook as a society and influenced our perception of the world around us, clearly to this day.

Anyway, have a look below.

On the very first day of 1946, January 1,  the first computer was completed by Mauchley/Eckert.  How about that!

January 10: we make first radar contact with the moon and the U.N. General Assembly meets for the first time in London, England.

January 17:  United Nations Security Council holds its 1st meeting

January 22: US president sets up the Central Intelligence Agency (CIA).  How about that!  And Rear Admiral Sidney W Souers, USNR, becomes 1st Director of CIA.

February 16: 1st commercially designed helicopter tested, Bridgeport Ct

In between January and February of 1946, Hungary, Yugoslavia, Bulgaria, and Albania form their dictatorships with Communism as their mantel.  Salazar in Portugal forms his dictatorship independently of the communist mantel.  And Franco continues his dictatorship of Spain.

February 14-15: Bank of England is nationalized

February 21: Anti-British demonstrations by Egyptians

February 24: Juan Peron elected president of Argentina

February 26: 2 killed & 10 wounded in race riot in Columbia Tenn

Mar 1st – Panama accepts its new Constitution

Mar 2nd – Ho Chi Minh elected president of North Vietnam; Kingman Douglass, becomes deputy director of CIA

Mar 5th – Winston Churchill’s “Iron Curtain” speech (Fulton Missouri)

Mar 9th – Ted Williams is offered $500,000 to play in Mexican Baseball League.  He refuses

Mar 12th – Part of Petsamo province ceded by Soviet Union to Finland

Mar 14th – Belgian creates several governments over the course of the year, beginning with Spaak.  Until then, Belgian was ruled by a monarchy.
Mar 15th – British premier Attlee agrees with India’s right to independence

Mar 22nd – Britain signs treaty granting independence to Jordan

Mar 28th – Cold War: The United States State Department releases the Acheson-Lilienthal Report, outlining a plan for the international control of nuclear power.

Mar 31st – The first election is held in Greece after World War II.
Apr 1st – 400,000 US mine workers strike
Apr 1st – Tsunamis generated by a quake in Aleutian Trench strike Hilo Hawaii;  Weight Watchers forms; Formation of the Malayan Union.

Apr 3rd – Netherland-German postal relations resume

Apr 7th – Part of East Prussia incorporated into Russian SFSR; Syria’s independence from France is officially recognised.
Apr 8th – League of Nations assembles for last time

Apr 13th – Eddie Klepp, a white pitcher signed by defending Negro League champ Cleveland Buckeyes, is barred from field in Birmingham Alabama

Apr 18th – Jackie Robinson debuts as 2nd baseman for the Montreal Royals;  US recognizes Tito’s Yugoslavia government

Apr 20th – 1st baseball broadcast in Chicago, Cards vs Cubs

Apr 21st – SED, Socialistic Einheitspartei Germany forms in East Germany (another dictatorship forms under the mantel of Communism)

Apr 27th – 1st radar installation aboard a commercial ship.
Apr 29th – 28 former Japanese leaders indicted in Tokyo as war criminals

May 1st – Start of 3 year Pilbara strike of Indigenous Australians; The Paris Peace Conference concludes that the islands of the Dodecanese should be returned to Greece by Italy; Fieldmarshal Montgomery appointed British supreme commander

May 2nd – Prisoners revolt at Alcatraz.  The revolt lasts two days.  Two guards and three inmates are killed.

May 7th – William H Hastie inaugurated as 1st black governor of Virgin Islands; Tokyo Telecommunications Engineering (later renamed Sony) is founded with around 20 employees.

May 8th: The Estonian school girls Aili Jõgi and Ageeda Paavel blow up the Soviet memorial that preceded the Bronze Soldier in Tallinn.  Aili was 14 years old at the time and very active in the resistance movement.  She was finally caught and found guilty as an under-aged terrorist and sent to a Gulag labor camp,  west of the Ural mountains. She was exiled from the Estonian SSR for eight years.

May 9th – 1st hour long entertainment TV show, “NBC’s Hour Glass” premieres

May 10th – Umberto II succeeds Victor Emmanuel III as king of Italy; Red Sox win 15th straight beat Yanks 5-4, DiMaggio hits Grand Slam

May 11: The United Malays National Organisation, (UMNO) founded and  is  presently Malaysia’s largest political part and a founding member of the National Front coalition

May 13th – US convicts 58 camp guard of Mauthausen concentration camp to death

May 25th – Abdullah ibn Hussein becomes king of Jordan

May 26th – Klement Gottwald becomes premier of Czechoslovakia.  He was a founding father of the Communist party in Czechoslovakia; Patent filed in US for H-Bomb.

Jun 2nd – Italian plebiscite chooses republic over monarchy (National Day)
Jun 3rd – US Supreme court rules race separation on buses, unconstitutional;  1st bikini bathing suit displayed (Paris)

Jun 6th – The Basketball Association of America is formed in New York City

Jun 7th – US Supreme Court bans discrimination in interstate travel

Jun 8th – Sukarno calls for anti colonial defiance in Indonesia

Jun 9th – Bhumibol Adulyadej, becomes king of Thailand; Joe Louis KOs Billy Conn in 8 for heavyweight boxing title

Jun 10th – Italian Republic established; Rear Admiral Sidney W Souers, USNR, ends term as 1st director of CIA Lieutenant General Hoyt S Vandenberg, USA, becomes 2nd director of CIA
Jun 13th – 1st transcontinental round-trip flight in 1-day, California-Maryland; King Umberto II of Italy abdicates

Jun 29th – British mandatory government of Palestine arrests 100 leaders of Yishnuv
Jul 1st – Rajah cedes Sarawak to British crown; US drops atom bomb on Bikini atoll (4th atomic explosion)

Jul 3rd – 1st Dutch government of Beel forms

Jul 4th – Philippines gains independence from US

Jul 14th – Dr Ben Spock’s “Common Sense Book of Baby & Child Care” published; Mass murder of Jews in Kielce Poland

Jul 15th – British North Borneo Co transfers rights to British crown
Jul 16th – US court martials 46 SS to death (Battle of Bulge crimes) in Dachau

Jul 22nd – Menachen Begin’s opposition group surprise attack on King David hotel
Jul 23rd – Menachem Begins opposition group bombs King David Hotel

Jul 24th – US performs atmospheric nuclear Test at Bikini Island; US detonates underwater A-bomb at Bikini (5th atomic explosion)
Jul 25th – At Club 500 in Atlantic City, New Jersey, Dean Martin and Jerry Lewis stage their first show as a comedy team.
Jul 26th – President Harry Truman orders desegregation of all US forces
Jul 26th – Aloha Airlines began service from Honolulu International Airport

Aug 1st – Pres Harry Truman establishes Atomic Energy Commission (AEC)

Aug 6th – US officially submits to jurisdiction of World Court
Aug 7th – 1st coin bearing portrait of Negro authorized
Aug 8th – India agrees to give Bhutan 32 sq miles

Aug 13th – Britain transfers illegal immigrants bound to Palestine, to Cyprus
Aug 16th – Great Calcutta blood bath – Moslem/Hindu riot (3-4,000 die)

Aug 17th – George Orwell publishes “Animal Farm” in the United Kingdom

Sep 1st – Greece votes for monarchy

Sep 2nd – Nehru forms government in India

Sep 8th – Bulgaria ends monarchy

Sep 20th – Churchill argues for a ‘United States of Europe’; The first Cannes Film Festival is held.

Sep 26th – 1st edition of Tintin (Kuifje), publishes until June 1993

Sep 28th – Greek king George II returns to Athens from exile

Sep 29th – Los Angeles (previously Cleveland) Rams play 1st NFL game in LA
Sep 29th – NPS, Nationale Party Suriname, forms
Sep 30th – 22 Nazi leaders found guilty of war crimes at Nuremberg; Von Ribbentrop & Hermann Goering sentenced to death by Nuremberg trial
Oct 1st – 12 war criminals sentenced to death in Nuremberg

Oct 8th – Kwo-less-shrew selects Gen Chiang Kai-shek as president of China

Oct 27th – Georgi Domitrovs National Front wins Bulgaria elections (78%)

Oct 28th – German rocket engineers begin work in USSR
Nov 1st – Charles S Johnson becomes 1st black president of Fisk University

Nov 3rd – Emperor Hirohito proclaims new Japanese constitution

Nov 4th – UN Educational, Scientific, & Cultural Organization formed
Nov 5th – John F Kennedy (D-Mass) elected to House of Representatives

Nov 9th – Pres Harry Truman ends wage/price freeze

Nov 12th – A branch of the Exchange National Bank in Chicago, Illinois opens the first ten drive-up teller windows.

Nov 15th – House Committee on Un-American Activities (HUAC) interrogates astronomer Harlow Shapley

Nov 21st – Georgi Dimitrov, a communist,  elected premier of Bulgaria

Nov 23rd – French Navy fire in Haiphong Vietnam, kills 6,000
Nov 23rd – The Workers Party of South Korea is founded.

Dec 3rd – US government asks UN to order dictator Franco out of Spain
Dec 5th – Pres Harry Truman creates Committee on Civil Rights by Exec Order #9808

Dec 11th – Spain suspended from UN; UN Children’s Fund (UNICEF) established (Nobel 1965)

Dec 12th – Tide detergent introduced; UN accepts 6 Manhattan blocks as a gift from John D Rockefeller Jr
Dec 13th – Leon Blum elected French premier

Dec 14th – Togo made a trusteeship territory of UN; UN General Assembly votes to establish UN headquarters in NYC

Dec 19th – War breaks out in Indochina as Ho Chi Minh attacks French in Hanoi

Dec 23rd – U of Tenn refuses to play Duquesne U, because they may use a black player in their basketball game
Dec 24th – 4th French republic established
Dec 24th – US General MacNarney gives 800,000 “minor nazi’s” amnesty

Dec 25th – Constitution accepted in Taiwan

Dec 26th – Flamingo Hotel in Las Vegas opens (start of an era)
Dec 31st – French troops leave Lebanon


 

 

 

 

 

 

 

 

 

 

 

 

 

Obamacare is Coming! Obamacare is Coming!

[Ed. note: Although I try and avoid political entries on this blog, the topic of this blog has been so politicized, that I am not able to avoid it.]

In spite of the fact that representatives in Congress have tried to repeal the Health Care Reform Act a whopping 40 times, open enrollment is due to begin on October 1 and the Health Care Reform Act, aka Obama Care, officially will go into effect the first of January 2014.  That is the good news.

The news that really chagrins me is that each time the obstructionists in Congress tried to repeal the law (which would actually benefit most American citizens) they did so to the tune of 1.5 MILLION dollars.  EACH time!  SIXTY MILLION DOLLARS of OUR tax dollars ended up being spent for what I can only conclude is shenanigans on the part of the obstructionists.  These are the same people who keep telling us that the government does not have enough money to operate.  They are the same people who can get the very best healthcare available at a 72-75% discount.*  As we have been the only developed nation in the world that still does not provide universal healthcare to its citizens, the actions of these obstructionists has been destructive.  Okay.  Politics over.  Back to the good news.

Starting October 1, people will be able to choose their healthcare coverage and healthcare provider.  Health insurers are no longer allowed to deny individuals with pre-existing conditions.  They are no longer allowed to drop individuals if they cost them too much or put a lifetime limit on benefits.

The following is the coverage that every citizen will have a right to regardless of the healthcare plan they choose.

Free annual check ups; Emergency services; Hospitalizations; Laboratory services; Maternity care; Mental health and substance abuse treatment; Outpatient, or ambulatory care; Pediatric care; Prescription drugs; Preventive care; Rehabilitative services; Vision and dental care for children.

Open enrollment will allow one to compare coverage options before enrolling.  In this new requirement that all citizens own health insurance, the government is offering an exchange rate between what the premiums cost and what the insured will have to pay. This exchange rate will be determined by the individual states.

In Virginia for example:

The average premium, without tax credits, would be $237 a month for the lowest-cost bronze plan and $335 a month for the second-lowest silver plan.

For a family of four making $50,000, a mid-range plan, after tax credits, would be $282 a month under the second-lowest silver plan. Without a tax credit, $799.

For a 27-year-old person earning $25,000 a year, the premium would be $80 a month, with a tax credit, for the bronze plan and $145 for the silver plan, also with a tax credit.

Six out of 10 Virginians who are uninsured will be able to find coverage for less than $100 a month when tax credits and Medicaid coverage are included.

 

© Yvonne Behrens, M.Ed  2013

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*According to the Congressional Research Service, the FEHBP offers about 300 different private health care plans, including five government-wide, fee-for-service plans and many regional health maintenance organization (HMO) plans, plus high-deductible, tax-advantaged plans. All plans cover hospital, surgical and physician services, and mental health services, prescription drugs and “catastrophic” coverage against very large medical expenses. There are no waiting periods for coverage when new employees are hired, and there are no exclusions for preexisting conditions. The FEHBP negotiates contracts annually with all insurance companies who wish to participate. There is plenty of competition for the business; FEHBP is the largest employer-sponsored health plan in the U.S.

Like other large employers, the government pays a large share of the cost of coverage. On average, the government pays 72 percent of the premiums for its workers, up to a maximum of 75 percent depending on the policy chosen. For example, the popular Blue Cross and Blue Shield standard fee-for-service family plan carries a total premium of $1,327.80 per month, of which the beneficiary pays $430.04. Washington, D.C.-based employees who prefer an HMO option might choose the Kaiser standard family plan. It carries a total premium of $825.15 per month, of which the employee pays only $206.29.  (Factcheck.org)

 

Multitasking Video Games that Stimulate the Brain

Back in 2006, I was sitting at a dinner table with my husband, a friend of ours (to whom my husband was also a consultant), and a Scientist.  The Scientist, who had been involved in creating a computer program to help children with learning disabilities (a program our friend was using in her Rehabilitation Center) was excitedly sharing with us that the same group that had created this program for children with learning disabilities had just come up with a new program to help re-stimulate the aging brain.

My maternal grandmother had succumbed to dementia.  She had been living alone for many years and although she had been living in a small French town where she knew many people and she had had a livelihood as an artist, arthritis had set in, impeding her ability to go out and paint.   My father, diagnosed with Parkinson’s disease, also developed memory loss.  My mother-in-law, a brilliant woman who was living with us at the time, in her 93rd year (albeit that is a nice old age) started to loose her mind.  It is not comfortable watching someone who was such a part of life fade into nothingness.  I suppose it will happen to many of us if something else does not get to us first, but…I digress.  Back to the dinner.

Needless to say, when I heard about this program, my ears pricked up and I recognized that this would be the next big step in extending the aging process.  I asked the Scientist how I could learn more about the program.  Our friend agreed that this program could be incorporated into her business, but that I would remain an independent representative of the company providing the Brain Fitness Program, Posit Science.

I loved the program and I loved introducing it to people.  Because it was the first of its kind, there were a lot of rough spots that the company kept tumbling over.  Some of it was proving the claims they were making, but most of it had to do with “meeting those profits.”  In the end, they never permitted their representatives to own a part of the company or even be a franchise, thus it could never develop into a business for me.  At around the same time that I recognized this, the company decided to only market via the internet.  Nevertheless, the concept is a sound one and since that time, other companies have developed their own programs.

Just recently, I came across an article that spoke about a Scientist who is using video games to the same effect.  In reading the article in The New York Times, I see that some of the same arguments are being put forth that were constantly surrounding the Brain Fitness Program: what are the positive effects; what are the negative effects; what are the long-term effects.  In spite of this, there seems to be positive responses for this new study:

The latest research was the product of a four-year $300,000 study done at the University of California, San Francisco. Neuroscientists there, led by Dr. Adam Gazzaley, worked with developers to create NeuroRacer,  a relatively simple video game in which players drive and try to identify specific road signs that pop up on the screen, while ignoring other signs deemed irrelevant.

Studies have shown that multi-tasking abilities diminish with age, starting in one’s ’20’s!  By the time people reach their ’60’s, the ability to multi-task has dropped by 64%.

But after the older adults trained at the game, they became more proficient than untrained people in their 20s. The performance levels were sustained for six months, even without additional training. Also, the older adults performed better at memory and attention tests outside the game.

“That is the most grabbing thing here,” Dr. Gazzaley said. “We transferred the benefits from inside the game to different cognitive abilities.”

In spite of these findings, the Scientists remain cautious.  It is not just playing video games that will re-stimulate one’s aging attention span and Dr. Gazzaley emphasizes the need to remain within the confines of scientific rigor. His study does include a further validation of the effectiveness of video games:

The researchers created a second layer of proof by monitoring the brain waves of participants using electroencephalography. What they found was that in older participants, in their 60s to 80s, there were increases in a brain wave called theta, a low-level frequency associated with attention. When older subjects trained on the game, they showed increased bursts of theta, the very types of bursts seen regularly in people in their 20s.

“We made the activity in older adults’ prefrontal cortex look like the activity in younger adults’ prefrontal cortex,” said Dr. Gazzaley, referring to a part of the brain heavily involved with attention.

All of this sounds very positive to me.  I still believe in the benefits of re-stimulating our neurons through interactive technology.  But I also appreciate that the brain is a sensitive organ which we are still in the process of understanding and, thus,  understand the Scientists’ caution.  In the meanwhile, just in case, I will buy myself some video games…..

 

© Yvonne Behrens, M.Ed  2013

 

Drug Addiction — The Pharmaceutical Kind

Recently I read an article in america.aljazeera. com entitled, “Painkiller Addiction Worst Drug Epidemic in U.S. History.”  According to the article:

In the United States, enough painkillers were prescribed in 2010 to medicate every American adult around the clock for one month.

That is a LOT of pills.  No wonder the pharmaceutical industry is one of the most lucrative money-making industries in the world!  You may recall that I wrote about an experience in my family which may not be so atypical given this article.

We have all heard about the extreme addictive qualities of  Vicodin and Oxycontin.    I had a friend who was battling cancer and her doctor had her on Oxycontin for five years.  He originally had prescribed it to her because she was feeling pain in her bones, but it was not long into her use that it was clear that she was hooked.  She made no apology and felt no remorse, choosing, understandably, a high that might decrease some of both the physical and emotional distress that her cancer was causing her.   Her story might be a justifiable one for the use of Oxycontin.  However, there are many stories of doctors who provide Oxycontin to their very wealthy patients on the most superficial of claims.

Oxycontin is the drug of choice among the wealthy and many articles have been written on the widespread misuse of this drug. In part this is because the Food and Drug Administration (FDA) has painted broad strokes for what constitutes enough pain to justify the use of Oxycontin.  In spite of the fact that there has been urging on the part of a group called “Physicians for Responsible Opioid Prescribing,” the FDA has done nothing to change their denotation of what constitutes justifiable pain.  This topic is rather slippery since the claim can be made that individuals do have different pain tolerance.  However, with the high levels of abuse that have been documented in the widespread use of Oxycontin, one might wonder whose pocket the FDA may be in.

After his resignation from his post as Commissioner of the FDA in December 1969, Herbert L. Ley, Jr., in an interview with the New York Times, warned the public about the FDA’s inability to safeguard consumers. People were being misled, he believed: “The thing that bugs me is that the people think the FDA is protecting them – it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day,” he said. …… Ley was critical of Congress, the Administration and the drug industry; he stated that he had “constant, tremendous, sometimes unmerciful pressure” from the drug industry and that the drug company lobbyists, combined with the politicians who worked on behalf of their patrons, could bring “tremendous pressure” to bear on him and his staff, to try preventing FDA restrictions on their drugs. The interview concluded with Ley stating that the entire issue was about money, “pure and simple”.[47][48]

This was back in 1969.  If anything has changed since then, it is that the pharmaceutical companies have even more leverage with the FDA.

In a 2005 interview, Dr. David J. Graham, associate director of the FDA’s Office of Drug Safety, was asked “What Specifically do you believe is broken in the FDA and what needs to be done to fix it? What must be done to improve the drug vetting system ?” his response: ” FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed.”

Back to the Aljazeera article I read on the American addiction to pain killers:

Prescriptions for painkillers in the United States have nearly tripled in the past two decades and fatal overdoses reached epidemic levels, exceeding those from heroin and cocaine combined, according to the Centers for Disease Control and Prevention (CDC).

At the same time, the first-ever global analysis of illicit drug abuse, published this month in the British medical journal The Lancet, found that addictions to heroin and popular painkillers, including Vicodin and OxyContin, kill the most people and cause the greatest health burden, compared with illicit drugs such as marijuana and cocaine.

High-income nations, such as the United States, the United Kingdom and Australia, had the highest rates of abuse, 20 times greater than in the least affected countries, according to the Lancet study.

It would seem that our love affair with pharmaceutical drugs is not doing a whole lot to help us in our health but it sure as heck is helping the pharmaceutical industries to make lots of money.

© Yvonne Behrens, M.Ed  2013

 

 

Fifty Years Ago

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

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

[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

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

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

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 Downthat 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

_________________________________________________________________________

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.