Winter Is Coming By SB Kayser

May 28, 2007

Man is an intelligent creature whose ability to reason depends on his environment entirely. In this respect, it is true that we're all interconnected. Thus living as a Man implies a choice: that of behaving like a human or worst... a monster of destruction.

The common people often regard the cycles of history as inexorable events with a feeling of powerlessness. And this bitterness tends to persist after reading "The Fourth Turning" by William Strauss and Neil Howe. The book explains why history unfolds just like the fours season cycles. Spring or High, Summer or Awakening, Autumn or Unraveling and Winter or Crisis. Entertainment is guaranteed: this fast paced read filled with intriguing esoteric meanings. Additionally, the authors' arguments are heavily documented. The occurrence of the four seasons is set in motion by successive generations of voters, with the 4th Turning (Winter) precipitating the collision course between the seniors exiting the voting process and the new first generation whose willingness is to revolutionize the ancient thinking. What characterizes The Autumn season is the realization that hopes have not materialized and are thus abandoned.... just after the millennium America will enter a new era that will culminate with a crisis comparable to the American Revolution, The Civil War, The Great Depression and World War 2...

http://www.moneyfiles.org/sbk04.html

or

http://www.opednews.com/articles/opedne_sb_kayse_070523_winter_is_coming.htm



Previous essays:
The " S " Words
Beyond Hysteria - The Final Squeeze

I’ve been thinking about Woodlawn By Fred Cederholm

Column for on/after May 28th

I’ve been thinking about Woodlawn. Actually I’ve been thinking about Memorial Day observances, America, “the program,” Uncle Ray, Lyle’s book, Uncle Ralph, eleven cemeteries, and our global military presence. Memorial Day, originally called Decoration Day, is a day of remembrance for those who have died in our nation’s service. It is observed on the last Monday in May. It began to honor the soldiers who died in the American Civil War, and after World War I - “the war to end all wars.” It was expanded to include those who died in any war or military action. It also honors living veterans.

You see my hometown - the little Village of Creston - like many thousands of small communities across this land, observed Memorial Day 2007 on Monday. It was a time to honor all the veteran service men and women – the living and the dead - and to reflect on their sacrifices in the preservation of the freedoms enjoyed by US/us all. The program and the following pot luck fellowship meal had been planned for our local cemetery, but the weather didn’t cooperate - so the events were moved to St. Johns Lutheran Church in Creston. This revised location seemed most appropriate as the sanctuary already predominately displayed the American flag and the East wall was adorned with a large banner bearing the image of a minuteman and displaying the words: “The land of the free, because of the brave.”

The program began (and ended) with a prayer. There was more music than usual this year. The 120 plus attendees were treated to a duet of Irving Berlin’s “God Bless America,” three vocal solos, two bagpipe numbers, and a medley of patriotic and religious songs by a local group of six men playing guitars and banjos. The twenty-or-so attending veterans of various services and conflicts each stood up and received the accolades of the others in attendance. They proceeded to the front of the church for the annual reading of the names of those service men and women buried at Woodlawn. Veterans entombed out there include one from the War of 1812, thirty-two from the Civil War, three from the Spanish American War, thirty-six from World War I, forty-seven from World War II, three from the Korean conflict, and three from the Vietnam conflict. Over time more will join them and that list will grow.

We know that since Memorial Day 2006 almost 1,000 more service men and women in Iraq have joined their fallen comrades. We have been forewarned that the coming months will be particularly costly in both casualties and injuries. We don’t know how many other military service veterans from various actions and conflicts – for one reason or another – have joined the list of departed souls in the past year. I know that my Uncle Ray Robinson, US Army Air Corps World - War II, was one of them. His wife, my mother Alice’s only sister, joined him in death a scant forty-three days later - just shy of what would have been their sixty-second wedding anniversary. I miss them both so very much.

During the program, local businessman and veteran Lyle Headon, US Marine Corps –Vietnam, gave an update on his current project of remembrance. For the past few years, he has been collecting the written recollections of those from the area who had served in World War II – a local version of Tom Brokaw”s “The Greatest Generation” if you will. It should prove to be an incredible tribute and history. I was honored to type up the story of my Uncle Ralph Byro’s involvement with the Army Air Corps in the Pacific theater during World War II. There was so much that I had never heard; I was deeply moved by his story. This is a truly important project because paper remembers, so we won’t forget.

After the fellowship meal at the church, the weather had cleared. I returned home and picked up my Scottish terrier MacIntosh II (aka Mac II) and we proceeded on a pilgrimage taking us to eleven local cemeteries visiting the graves of so many family and friends, and paying our respects. This is kind of a local tradition as there were others going from cemetery to cemetery doing likewise. At Rochelle’s Lawnridge Cemetery, I briefly visited the grave of Major Thomas F. Koritz – USAF F15 E Pilot and Flight Surgeon KIA (killed in action) during Operation Desert Storm on January 17, 1991.

Last Sunday at church, I noticed a change of wording at the end of our prayer list petitions: “We remember our military personnel stationed everywhere (my emphasis) in the world, especially in Afghanistan and Iraq, and wisdom for all world leaders and peace for all.” It hit me like a thunderbolt that the realities of our times and the assumed role of the United States of America have caused our service man and women to be stationed (overtly and covertly) literally everywhere around the globe. That is a very heavy thought. I’m Fred Cederholm and I’ve been thinking. You should be thinking, too.

Copyright 2007 Questions, Inc. All rights reserved.

I’ve been thinking about immigration by Fred Cederholm

Column for on/after May 20th, 2007 by Fred Cederholm

I’ve been thinking about immigration. Actually I’ve been thinking about ambivalence, history, legislation, amnesty, “in-sourcing,” and beacons. Unless you descended from American Indians, your ancestors came to the United States from somewhere else. We are a nation of immigrants – peopled from all over the globe. For most of our history, US/us effectively had an open door honor system – not any more. We find ourselves now in big mess; we honestly don’t know how to deal with it.

You see the whole issue of immigration is something I haven’t addressed in the over 3 & a half years I’ve been writing my weekly columns. I clearly have mixed feelings regarding this because my ancestors all arrived here between 1870 and 1895. They were all legal in the sense that they observed the laws and procedures in force at the time. All arrived in New York City as teenagers and were processed at Ellis Island (or Philadelphia) where they provided their name, country of origin, and US destination. They might have received a cursory physical, or might have been asked if they had a sponsor waiting for them at their destination before they were sent on their merry way. There were no federal, state, or local bi-lingual or financial assistance programs awaiting them. They all expected to work from the get go, to learn English on their own, and to became “Americans.” Most ancestors of the people I know share this story of repatriation to the US. But (and there is always a but…) times, procedures, and policies change.

The Federal Government assumed the task of inspecting, admitting, rejecting, and processing all immigrants seeking admission to the US in 1891. The Immigration Act of 1907 reorganized the states bordering Mexico (Arizona, New Mexico and a large part of Texas) into Mexican Border District to stem the flow of immigrants there. Various laws established the quota system and imposed passport requirements until a 1924 act reduced the number of US immigration visas allocating them on the basis of national origin. The Alien Registration Act of 1940 required all aliens (non-U.S. citizens) to register with the Government and receive the predecessor of the "green card." In 1950 immigrants with legal status had these cards replaced with Form I-151, the "green card." Requirements and paperwork rose.

The modern day US immigration system was established in 1952. It created a quota system on a per-country basis and a preference system giving priority to family members, or people with special skills. Discrimination based on race, place of birth, sex and residence was eliminated on paper by decree in 1968. It also officially abolished restrictions on Oriental US immigration. In 1976, any preferential treatment for residents of the Western Hemisphere was “eliminated.” The policy on refugees was “clarified” in 1980. While the paperwork and bureaucracy had continued to rise, enforcement had been so lax that the fix in 1986 focused on curtailing illegal US immigration “by law.” It legalized hundreds of thousands of illegal immigrants. Over the past 20 years that flow of “non-complying guest workers” has escalated to a point where there are now somewhere between 12 and 20 million more of them here.

Amnesty is the attempt to spin any mess that has gotten so big because either the laws were so bad to begin with, or the enforcement of them was so shoddy. Now… the only viable “solution” is being marketed to the public by giving the non-complying parties another pass, and a chance to right (or to fix) their illegal status by a new set of rules and policies. This bi-partisan proposal only squeaked through the Senate last week. It may sound good in the media blitz of talking points and sound bites, but how will another “voluntary” proposal - with still more requirements, paperwork, and bureaucracy - be the fix? Where is any enhanced enforcement (with teeth) giving credibility to this so-called solution?

It is argued that we need to “open the system” to obtain the workers to do the tasks our own citizens will not perform. That is barely even selectively true. In a true market system, the needs of the demand will be met by the forces of supply when the financial incentives – increased wages - are provided to draw in the requisite work force. In essence, this is a matter of curtailing labor wages and benefits to fluff the bottom lines by opening our borders to a bigger pool of lower cost workers – a new exploitative form of in-sourcing, if you will. Since when did the beacon motto of Lady Liberty in New York harbor state: “Give me your tired, your poor, your huddled masses; yearning to work cheap” ? I’m Fred Cederholm and I’ve been thinking. You should be thinking, too.

Copyright 2007 Questions, Inc. All rights reserved.

To “audit” this column and to learn more about the subjects discussed, please check out:

US IMMIGRATION HISTORY
http://www.rapidimmigration.com/usa/1_eng_immigration_history.html


Center for Immigration Studies
http://www.cis.org/articles/1999/back699.html

The Statue of Liberty – Ellis Island Foundation
http://www.ellisislandrecords.org/

The Changing U.S. Portrait
http://www.clearchanneloutdoor.com/assets/downloads/pdf_multicultural/ChangingUSDemographics.pdf

THE UNITED STATES POPULATION IN TRANSITION
http://usinfo.state.gov/journals/itsv/0699/ijse/capop.htm

Megatrend #1: Changing Demographics
http://www.learnframe.com/aboutelearning/page10.asp

Coping with Changing Demographics. ERIC Digest Series Number EA45.
http://www.ericdigests.org/pre-9214/coping.htm

Illegal Immigration Counters
http://immigrationcounters.com/

U.S. immigration bill attacked from left and right
http://www.alertnet.org/thenews/newsdesk/N18220004.htm

Senate Passes Immigration Bill: GOP Divided Heading into Tough Negotiations with House
http://www.cnn.com/2006/POLITICS/05/25/immigration/index.html

22 Problems With The Senate's Illegal Immigration Bill
http://www.rightwingnews.com/john/specialimm.php

Cost of Senate Immigration Bill Put at $126 Billion
http://www.washingtonpost.com/wp-dyn/content/article/2006/08/21/AR2006082101539.html

To Immigrants, US Reform Bill is Unrealistic
http://www.csmonitor.com/2007/0521/p01s04-ussc.html

Down with any elite! By Joost van Steenis

Amsterdam May 21 2007

Dear reader, this is the 86^th letter of an Autonomous Thinker.

Down with any elite!

In a New World all people will have equal status.

In our Old World the most powerful people, the elite, do not agree with this human demand. They live in a safe and prosperous eliteworld that differs immensely from the often harsh massworld where the vast majority of humans live.

You cannot expect that the massworld will fundamentally change when elitepeople at the highest level demand an elevated status for themselves.

The first and foremost goal of elitepeople is the preservation and improvement of the own world. It is never a preconceived idea to improve the massworld at the cost of the situation in the eliteworld (though some elitepeople seem more friendly in regard to masspeople than others).

All unequal relations in our world are a consequence of the fundamental and dominating inequality between elite and mass.

I analysed this inequality for example in the Letters numbered 3, 9, 24, 35, 37, 51, 56, 57 58, 68, 74 and 85. You can find these Letters by replacing the XX in the address http://members.chello.nl/jsteenis/LetterXX.htm by the number of the desired Letter..

When the most important inequality is not reduced and annihilated, all efforts to improve the position of the masses will be idle. Leftists or populists have sometimes some positive result but in the long term the world does not change.

To get a world in which all people have equal status new ideas must replace old political ideas. Activities connected with elections, trade-unions, petitions, demonstrations, fighting with the police etceteras only affirm the position of the elite because they do not directly influence the life of elitepeople.

On the road to a New World the masses should act in such a way that new elites will never rise again. When the most important inequality in the world – the inequality between elite and masses – has disappeared other inequalities will also vanish.

I described some actions against elitepeople in my book The Power of an Autonomous Human ( http://members.chello.nl/jsteenis/power.htm). Elitepersons were forced to give attention to arguments of mostly unknown masspeople.

This political struggle has two sides.

The elite must realise they cannot live anymore in the secluded and superior eliteworld.

When the masses realise they have power to force the elite to behave in another way they will not want to live anymore in a massworld that is inferior and subordinated to an eliteworld.

Actions should be carried out in the private living sphere of elitepeople instead of in and around their working place. The pressure and the harassment in the private living sphere makes the eliteworld less nice to live in. These peaceful actions penetrate in the brain of elitepersons and change their behaviour.

Elitepeople will become more conscious of the human assumption that all people should have equal status.

Masspeople can become active in an individual and creative manner on the place, the time and the way they choose and against a leader they select.

They will not anymore be dependent on what others, especially leaders of mass organisations, dictate.

In this way the consciousness, the autonomy and the individuality of masspeople will increase because they perceive they have the power to change the world.

My site is dedicated to this kind of actions that fundamentally differ from the present actions of leftist, populist of rightist mass organisations.

Direct Action will take the place of democratic elections in which masspeople transfer their power to representatives who in the first place listen to the directives of the still higher eliteworld.

To replace the Old World by a New World in which all people will have equal status masspeople must invade the superior eliteworld in order to create One World for all humans.

Yours truly, Joost van Steenis

http://members.chello.nl/jsteenis

New ways to increase masspower

History of Gun Control Whether you agree or not By J. Jaeger

THE BLESSINGS OF LIBERTY

History of Gun Control Whether you agree or not, it's an interesting lesson in history.

In reaction to the Virginia Tech shootings... Rather than declare the shooter as "nuts," some in Congress want everybody to give up their firearms in violation of the 2nd Amendment to the US Constitution. Below are an examples of what happened when governments confiscated privately held firearms.

Something to think about...

In 1911, Turkey established gun control. From 1915 to 1917, 1.5 million Armenians, unable to defend themselves, were rounded up and exterminated.

Germany established gun control in 1938 and from 1939 to 1945, a total of 13 million Jews and others who were unable to defend themselves were rounded up and exterminated.

In 1929, the Soviet Union established gun control. From 1929 to 1953, about 20 million dissidents, unable to defend themselves, were rounded up and exterminated.

China established gun control in 1935. From 1948 to 1952, 20 million political dissidents, unable to defend themselves, were rounded up and exterminated.

Guatemala established gun control in 1964. From 1964 to 1981, 100,000 Mayan Indians, unable to defend themselves, were rounded up and exterminated.

Uganda established gun control in 1970. From 1971 to 1979, 300,000 Christians, unable to defend themselves, were rounded up and exterminated.

Cambodia established gun control in 1956.. From 1975 to 1977, one million 'educated' people, unable to defend themselves, were rounded up and exterminated.

Defenseless people rounded up and exterminated in the 20th Century because of gun control: 56 million.

Australia

It has now been 12 months since gun owners in Australia were forced by new law to surrender 640,381 personal firearms to be destroyed by their own government, a program costing Australia taxpayers more than $500 million dollars.

The first year results are now in:

Australia-wide, homicides are up 3.2 percent

Australia-wide, assaults are up 8.6 percent

Australia-wide, armed robberies are up 44 percent
-- yes, 44 percent!

In the state of Victoria alone, homicides with firearms are now up 300 percent. Note that while the law-abiding citizens turned them in, the criminals did not, and criminals still possess their guns!

While figures over the previous 25 years showed a steady decrease in armed robbery with firearms, this has changed drastically upward in the past 12 months, since criminals now are guaranteed that their prey is unarmed.

There has also been a dramatic increase in break-ins and assaults of the ELDERLY. Australian politicians are at a loss to explain how public safety has decreased, after such monumental effort and expense was expended in successfully ridding Australian society of guns. The Australian experience and the other historical facts above prove it.

You won't see this data on the American evening news or hear our president, governors or other politicians disseminating this information. Guns in the hands of honest citizens save lives and property and, yes, gun-control laws affect only the law-abiding citizens.

Take note my fellow Americans... before it's too late!

The next time someone talks in favor of gun control, please remind them of this history lesson. With guns, we are "citizens." Without them, we are "subjects."

I’ve been thinking about pressure by Fred Cederholm

Column for on/after May 13th, 2007

I’ve been thinking about pressure. Actually I’ve been thinking about Iraq, 11 incumbents, the November 2006 elections, the November 2008 elections, the summer of our discontent, history/ historiography, and the Holy Lands of the Middle East. Last week saw the unfolding of some events which I would have never expected. In the broader scheme and context of the ongoing action(s) in Iraq, things continue on pretty much as I expected. But then again, there were occurrences and disclosures which actually made the news that give rise to some hope that “the times, they are a changing.”

You see 11 members of the Republican Party (who were lucky enough to be in those now minorities of GOP incumbents who were re-elected last November) met with Bush, Cheney, Rice, and Snow to air their concerns, and to question the unflinching dogma of “saying the course” in Iraq without some modification of what that course of action is. No one should ever doubt that this past election was a referendum on Iraq. The Democrats were swept into only “virtual” controlling majorities in both the US House and the US Senate. Given the checks and balances of our Constitution; the Dems still lack the mandate of a two-thirds majority needed to override a Presidential veto. Congress still has the power of the purse, but the President is the Commander-in-Chief and has the power of the veto. Therein lies the rub and gives rise to what amounts to as the ultimate supremacy of the pressure of public opinion.

In keeping with campaign promises which had courted the public opinion against the continued occupation and bloodletting in Iraq, the first salvo of a “continued” war funding bill came with the caveats of a timetable with benchmarks measuring progress toward some ultimate ending of the “action” there. Bush didn’t blink, and vetoed the bill. He met with the new Congressional leaders not even giving any credible lip service to compromise for a litany of reasons – all of which we’ve heard before. Bush can’t run again in 2008. He hitched his wagon to the outcome in Iraq. His legacy rests there, and there alone. I hesitate to call this a “war” because like all other conflicts in my life time, there was no Act of War declared by Congress. There was merely an authorization/deferral of “war” powers to the President.

Now… Congress can blink and authorize the continued funding; giving Bush what he wants. Or, they can try a second, third, or fourth attempt to link restriction/ benchmarks to the money. Without a veto over-riding majority (by picking up the needed cross-over votes from a requisite number of Reps bolting from the Bush camp) there will be an on-going stalemate. The rhetoric will escalate as to who is supporting our troops, and the mud slinging from both camps would get really dirty. Congress is putting pressure on Bush TO give in. The general public is putting pressure on Congress NOT TO give in.

Both the Dems and Reps (with the 2006 elections fresh in mind) are looking to those coming in 2008. They both know what the public giveth in one election; the public can taketh in the next. It should be noted that the most recent polls show BOTH the President AND the Congress with a less than a 30% approval rating and a greater than 70% disapproval rating. The 11 who met at the White House candidly argued how continuation of policy was killing them in their home districts. Will they (and others) cross to join Democrats in overriding Bush? We are clearly in for a summer of discontent - and arm twisting.

We only TH*NK we know the history behind how we got to this quagmire in which we now find ourselves. We have already learned the original justifications for action in Iraq were not as represented. On one hand, subsequent justifications of building a real democracy in Iraq, building a lasting peace in the Middle East, and reconciling the Shias with the Sunnis with the Kurds - while altruistic – are about as believable as the justifications that this war and occupation is only about oil, about money, or about profits. The truth IS out there, but I honesty believe we haven’t heard very much if it – not yet anyway.

Historiography is a “history” of histories. While each generation may make its own history, each subsequent generation re-writes it to serve its own purposes. Did any (outside) force in all of written history really bring peace, love, and harmony to the Holy Lands of the Middle East - ever? The British? The Ottoman Turks? The Crusaders? Mohammad? Jesus the Christ? The Romans? The Sanhedrin? Pontius Pilate may have taken the only sane approach when he publicly washed his hands of the riotous situation he faced in 34 AD. I’m Fred Cederholm and I’ve been thinking. You should be thinking, too.

Copyright 2007 Questions, Inc. All rights reserved.

I've been thinking about escorts by Fred Cederholm

column for on/after May 6th 2007

          
I've been thinking about escorts. Actually I've been thinking  about scandals, words, outings,
fantasies, Johns, and doublespeak,   Last week saw the accelerated leaking of a scandal
in Washington DC which heralds  from the State Department to the Pentagon, from K-Street
to the media, and from law firms to academia. A "fantasy purveying entrepreneur" in California 
who had been indicted for running an "escort" service in our nation's Capitol wasn't going to
just plead out and run. She was going to name names by taking her little black book -
or should I say her phone logs - public. She promises that her lawyers will potentially subpoena
any client as a defense to testify "ain't nothin' dirty going on."  (Dum, dum-de-dum, 
dum-dum! - The minute you walked in the joint, BOOM-BOOM, I could see you were a
man of distinction, A real big spender, Good looking, so refined.)

          
You see more than our world is changing before our eyes - our very vocabulary of favored
words and expressions is morphing before us as well. I pride myself on being a wordsmith -
carefully selecting the appropriate words for use in each of my columns. A William F.
Buckley might put it "as not being too much the pedant in parsing the absolute semantic
nuance."  In Fredspeak: "Ya can't be too careful in pickin' the right word." (Say, 
wouldn't you like to know What's going on in my mind?)

          
As more and more words and/ or phases are being "re-defined" in ways that befuddle
a Merriam-Webster, I find myself being ever more careful not to "faux pas" (French -
"for foot in mouth") with an UNINTENDED double-entendre. My deliberate ones are
just fine because they add to the entertainment value of the THINK*NG's. (Did he
just say what I TH*NK he did?) Am I the only one old enough to remember when
being/feeling "gay" meant happy or festive - instead coming across as dour or
morose?  An douting" used to refer to a field trip, or a picnic. A "fantasy" was 
some pipe dream like maybe getting to drive a Ferrari, or in the negative, 
not having a golf score that would make any bowler proud (or vice versa). (Do 
you wanna have fun? Ssssssssssss... How's about a few laughs?)

          
As this titillating saga about moral failings in the beltway unravels, not only will
the wars, the economy, the dollar, the markets be short-sheeted; but Paris,
Brittney, Anna Nicole, and company will be as well. We will see more of our f
amiliar words and expressions re-defined in the unending efforts to accentuate
the positive and mitigate the negative. I remember how "escort" (the noun and
the verb) once referred to a father proudly walking his daughter down the aisle
at her wedding, or a young high school couple proceeding in the grand march of
their Spring Prom. This "escorting" was done before a large audience of family and
friends. Put those rights of passage into this current usage and the something innocent 
and beautiful seems downright kinky. (How's about (fun, fun, fun) a few laughs?
I can show you a...good time...)

        
To date, we only know the names of a few participants in this "companionship of 90
minutes for $275 bucks" business. Still., we also know that numerous "Johns" have
hired the most expensive of DC's lawyers - at even far larger hourly fees - to keep
their names out of the limelight. The use of "Johns" as an anonymous class actually
has its origins in the Book of Revelations. John was the last of the apostles who was
entrusted with writing of the Prophesy of Revelations. His subsequent followers of 
anointed/ enlightened ones were called the "John Class." They were chosen to 
be keepers of the faith during the times of trial. Those "Johns" are a far cry from these
"Johns," but this is yet a further example how words/ phrases are spun and twisted to
mislead. (So, let me get right to the point, BOOM-BOOM, I don't pop my cork for every
guy I see. Hey, big spender! Hey, big 
spender! )

        
This story will not go away and the anonymous Johns (and Janes) will continue to be
dragged out into the light of day. Were it not for the tragedy of the destroyed lives,
careers, and families; this coming summer fest of true reality TV would be something
to savor (and relish) in some pious, sanctimonious, voyeuristic, gratifying way. But remember.
only he who is without sin should cast the first stone. Or, to paraphrase our former 
President "Slick:" it only counts as sex, if you BOTH enjoy it. (Hey, big spender! Hey, big
spender! Spennnnd..a little tiiiiime with ...me! Dum, dum-de-dum, dum-dum!) I'm Fred
Cederholm and I've been thinking. You should be thinking, too.

Copyright 2007 Questions, Inc. All rights reserved.


The lyric excerpts included throughout in the text of the column are from
the song "Big Spender" - music by Cy Coleman (1929- 2004) and Lyrics by
Dorothy Fields (1905- 1974). This appeared in an opening scene of the Bob
Fosse Musical "Sweet Charity" which opened on Broadway January 29, 1966.All
lyrics are property and copyright of their ownersand are provided for
educational purposes only.

You may not have gotten TH*NK*NG MARKETS for some reason. This one has done
very well with readers of other sites and is definately in line with the
message of Moneyfiles and real wealth society.

Fred C asklet@rochelle.net

Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval

Dr. Peter Rost

The drug is maraviroc, and it will be the first CCR5 receptor antagonist on the market. This group of drugs blocks a secondary but crucial doorway typically used by the human immunodeficiency virus to enter white blood cells. Barbara Ryan, analyst for Deutsche Bank North America, projects that annual sales will peak at $500 million by 2011.

But now there’s a fly in Pfizer’s ointment; an internal whistleblower, whom we’ll call Jane Roe. She claims that Pfizer used the HIV sales force to illegally promote the drug to doctors before approval.

Roe says that the illegal conduct started already in November 2006, when Pfizer was trying to set up “expanded access sites” throughout the country for a maraviroc experience trial. The sales reps were used as liaisons to help medical affairs enroll new research sites and the sales reps were allegedly asked to promote the “trial,” in which doctors were paid $1200 per patient for one year, along with free drug.

Evidence of this, Roe says, is an “unapproved slide set” for maraviroc, which was given to some HIV sales reps in November 2006. The reps were then asked to give these slides to key doctors (download the-smoking-gun presentation here) The slides were allegedly used to “goose the skids” as well as in verbal discussions which included data outside what was published. Roe claims she was asked to slip the slide presentation on a memory stick to physicians whom the company trusted.

Roe points out that the actual paying of a fee to institutions is not generally wrong but using sales reps to promote a drug before approval violates FDA rules. Normally drug companies avoid using the sales force in any prelaunch activity, because it looks by definition like, well, selling . . . . and they need FDA approval to do that.

Roe says that some reps expressed concern to her, but were unwilling to rock the boat and went along with this unusual task. She says many physicians were also concerned that she and her colleagues were putting themselves in a difficult situation by participating in this program and some were upset.

Roe goes on to say that, "a researcher told the medical director she wasn't interested and said very loudly she did not know we were coming in to strong-arm her. It was during a lunch meeting at her office and very uncomfortable. I think as a result of these actions at the very least people thought we were inept running around with sales reps and a medical director who had never worked in a clinic or had no HIV experience. "

Roe claims this effort was directed by senior sales management and medical affairs, and she has shown me an e-mail from a Pfizer medical director for the HIV team, with an MS, PhD degree after the name, which supports the allegation that there was an ongoing coordination between medical affairs and the sales force to enroll physicians in the trial. Roe also says she was part of several meetings the medical director had with doctors.

In fact, Roe and some others in the sales force were so disturbed by this program that they not only objected to the company, but also recently reported this to the HHS Office of the Inspector General. (Pfizer has been forced to sign a Corporate Integrity Agreement, and any violation of this agreement is handled by the OIG.)

The sales force promotion of the “trial” went on until January 2007, when the sales force involvement was abruptly stopped. Also noteworthy, is that Roe says the sales reps were recently asked to delete all materials related to maraviroc.

A closer scrutiny of the slide presentation reveals that the author name electronically embedded in the presentation is not the doctor on the first slide, but “Peter Pinkowish.”

His name can be found on another HIV related slide presentation, for Bristol-Myers Squibb (available for download here), in which his title is “Medical Editor.” So here we have the first clue that this was a slide show written by a hired goon. That smells marketing. In yet another medical paper, related to hormone therapy Pinkowish's title is “Medical Writer,” and it wouldn’t be far-fetched to assume that this is a person working for a medical education agency, churning out advertising disguised as semi-scientific papers and presentations for drug companies.

So why would Pfizer risk its reputation, using the sales force to premarket doctors?

Roe responds, "It is my understanding the enrollment has hit several obstacles because as I mentioned the complexity of miraviroc as well as the test that need to accompany it. The research shows half of all people or thereabouts cannot safely take this product. It has become a very difficult issue which is why in my opinion they enlisted the sales force to get buy-in prior to approval. It has become clear that Pfizer's commitment to HIV may depend on the approval and success of this product. Maraviroc provides a needed benefit to HIV patients and even though it may never be a Pfizer blockbuster it fills a gap since the current Pfizer HIV product Viracept is almost 9 years old and not considered first line very often. It seems this was a desperate attempt to impact futures sales; I guess some call this premarketing I call it bullshit and against the law."

http://peterrost.blogspot.com/

I’ve been thinking about dealings By Fred Cederholm

Column for on/after April 29nd

I’ve been thinking about dealings. Actually I’ve been thinking about the “new globalism,” US energy imports, nationalizations, Canada, Iran, and American policy. Since the first of the year, there has been an escalation of disclosures (in the international media - anyway) regarding diplomacy, negotiations, deal making, agreements, joint ventures, and the building of peaceful bridges to “insure” a secure future supply of energy for many of the world’s players – both by the sellers and the consumers.

You see our world continues to change around us – so much more than we realize. In the 1920’s, President Calvin Cooledge coined the phrase: “the business of America is business.” Now… in these beginning years of the 21^st Century, it can be argued how “the business of the world is business.” There can be no doubts that the real players on the global scene mean business. True…, there are strong undercurrents of national self-interest and national self-determination at play, but the real news is being driven by the actions/re-actions of the multi-national (or supra-national) conglomerates/corporations who are really calling the shots. While most of the planet has been dealing, there is the perception that Uncle $ugar has been only reeling and wheeling. Just what is going on here, and what needs to change?

US/us continues to dependent on foreign suppliers for roughly two-thirds of our current level of energy consumption - with a marginally different mix of the suppliers. The top eight sources of Uncle $ugar’s crude oil imports for February 2007 were: Canada (1.838 MILLION barrels per DAY--MBPD), Mexico (1.358 MBPD), Saudi Arabia (1.185 MBPD), Venezuela (1.115 MBPD), Nigeria (1.061 MBPD), Angola (0.451 MBPD), Algeria (0.392 MBPD), and Iraq (0.325 MBPD). Uncle $ugar’s top eight sources of total petroleum imports for February 2007 were: Canada (2.386 MILLION barrels per DAY--MBPD), Mexico (1.507 MBPD), Venezuela (1.353 MBPD), Saudi Arabia (1.207 MBPD), Nigeria (1.102 MBPD), Algeria (0.554 MBPD), Angola (0.464 MBPD), and Iraq (0.325 MBPD). These figures for the February 2007 imports were made available by the Energy Information Agency of the US Department of Energy on April 17, 2007.

In South America, the trends toward nationalization (or repatriation) of the energy controlling interests accelerated. Non- domestic ownership/ control diminished as the oil rights (and rights to future profits and cash flow) were nationalized, bought-out, or at a minimum re-negotiated. Contracts ceding control of Bolivia’s oil and gas reserves from foreign companies to the Bolivian Government officially came into force on April 24, 2007. These relate to the 44 contracts signed with 10 different global energy conglomerates last October. Last Wednesday in Venezuela; Chevron, BP, France's Total and Norway's Statoil agreed to cede control of Venezuela's last remaining privately run oil projects to the Chávez government. ConocoPhillips resisted and was warned its fields could be taken over outright.

Working in the other direction, Statoil ASA, Norway’s biggest oil company, agreed to buy Alberta, Canada based North American Oil-Sands Corp. to replace future dwindling reserves from the North Sea and Venezuela for $2 BILLION. Royal Dutch Shell Plc paid $2.2 BILLION) for Calgary-based BlackRock Ventures Inc. last year gaining greater access to the Alberta oil sands. Paris-based Total SA acquired Canada's Deer Creek Energy Ltd. for $1.67 BILLION (Canadian $) in 2005.

It seems like the world (sans US up to this Monday) has been beating a path to Iran to cut deals and hammer out long term investments and/or forward-looking energy supply agreements. The Dutch, the Austrians, India, China, and others have already cut deals with Iran and still more were announced just last week. Many projects include joint-venturing and external funding of the expansion/ modernization/ development of Iran’s energy/ petro-chemical infrastructure. This is an insurance policy against attacks or pre-emptive strikes for Ahmadinejad and Iran because such agreements gain them allies and support. Then too, many of those “strategic targets” would be co-owned/financed by others.

The US has officially opposed all these developments - pushing for increased sanctions/ embargos instead. George W. Bush is American’s first President to have an MBA (Harvard 1975). It is high time for him to start functioning as more as a CEO and less as a Commander-in-Chief. Communication lines with Iran have been severed for 28 years, (given the Monday morning news rumblings) THAT is going to change. Hallelujah! I’m Fred Cederholm and I’ve been thinking. You should be thinking, too.

Copyright 2007 Questions, Inc. All rights reserved.

To “audit” this column, and to learn more about the subjects discussed, please check out:

February 2007 Energy Import Highlights: Released on April 17, 2007

http://www.eia.doe.gov/pub/oil_gas/petroleum/data_publications/company_level_imports/current/import.html

U.S. Crude Oil Field Production (Thousand Barrels) http://tonto.eia.doe.gov/dnav/pet/hist/mcrfpus1m.htm
Statoil takes eco-risk http://www.aftenposten.no/english/business/article1759761..ece
Statoil to Pay $2 Billion for Canadian Oil Company http://www.bloomberg.com/apps/news?pid=20601085&sid=aH52Ilvd40Yw&refer=europe
Canadian Oil Sands Trust announces 2007 first quarter results and a quarterly distribution increase to $0.40 per Trust unit and 2007 first quarter results http://www.earthtimes.org/articles/show/news_press_release,95027.shtml
Four oil firms cede control to Venezuela's Chávez Caracas, Venezuela http://seattletimes.nwsource.com/html/nationworld/2003681621_wdig26.html
Bolivia Takes Control Of Energy Reserves From Foreign Firms http://www.industryweek.com/ReadArticle.aspx?ArticleID=14050

Shell defies US pressure and signs £5bn Iranian gas deal http://www.guardian.co.uk/iran/story/0,,2001515,00.html
US cautions Austrian oil giant over gas deal with Iran http://rawstory.com/news/afp/US_cautions_Austrian_oil_giant_over_04232007.html
Iran, China close to oilfield deal http://www.presstv.ir/detail.aspx?id=5570§ionid=351020103
Indians to invest $15 billion in Iran http://www.presstv.ir/detail.aspx?id=5922&sectionid=351020102
America prepares to talk with Iran after 28 years of silence http://www.timesonline.co.uk/tol/news/world/us_and_americas/article1723160.ece
Putin Lures In The Middle East http://www.rense.com/general76/putin.htm
Russia Plans World's Longest Tunnel, a Link to Alaska http://www.bloomberg.com/apps/news?pid=20670001&refer=home&sid=a0bsMii8oKXw

WHERE IS THE LOVE? The Honeymoon's Over for Bush and the Saudis

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/27/AR2007042702054.html