Monday, January 31, 2011

POLITICAL COMMENTARY--Political Revolt in Egypt and it's Repercussions for the West

by Bill Breakstone, January 30, 2011

The world is currently focused on the crisis evolving in Egypt, where Hosni Mubarak’s regime is coming under intense pressure to resign and allow democratic elections to install a more responsive government to address the ills of the Egyptian society.

The basis of this popular revolt is an extreme dissatisfaction with a government that has failed to serve its people, who have suffered from high unemployment, lack of human rights, and an increasingly high cost of living.

The visuals coming out of Cairo, Alexandria and Suez City are terribly frightening, with a total lack of civil security, looting, gunfire, and a population forced to provide for its own basic essentials.

This revolt was fueled by the events that took place in Tunisia over the past two weeks, and are currently continuing in Yemen. It is also feared that similar outbursts of popular resentments will spread to other Arab nations such as Lebanon, Syria and Jordan.

People have questioned what is fueling these events. The answer is simple. When governments ignore the needs of their people, tensions and resentments mount until they reach a point of combustion.

Robert Reich spelled out such a scenario that could occur in America in his excellent book “Aftershock.” Here, the middle class has come under increasing pressure to provide for itself as their outlook has deteriorated over the past three decades, while those more fortunate have increased their position in life by leaps and bounds. Unemployment is at near all-time highs, and not expected to rebound for another five years, while at the same time corporate profits and earnings are setting records. The cost of living is increasing as food and fuel prices have risen dramatically, while the values of most people’s assets have continued to deteriorate, thanks no little to a housing market that continues to decline due to excess inventories fueled by foreclosures resulting from the financial crisis of 2008-2009.

Meanwhile, the American political environment is mired in a ideological conflict between an administration that is trying to address continuing high unemployment and sluggish growth and an opposition party focused on reducing the role of government and slashing spending to reduce a huge federal deficit, which most probably will result in increasing joblessness that will negatively affect the economy.

The question is when could the American people wake up one morning and witness the kind of events that we are seeing today on the streets of Cairo? What could be the tipping point when the great mass of the American middle class decides that our government is not providing for its people? Several months ago, no one could have predicted the events that are now unfolding in Egypt. They are a perfect example of what economists and political scientists refer to as “asymmetric shock,” an event that can tilt a nation’s economy off its axis with disastrous consequences.

The hope is that our opposing political factions can come together in a spirit of compromise to avoid policies that could endanger our future, as they did in the lame duck session last month. But the rhetoric being heard, regarding an extension of our debt ceiling is not promising. The last thing we need at this point is a shutdown of the government, which will only exacerbate the perception on the part of our population that our leaders cannot deal with the challenges that face us.

So, keep your eyes on Egypt. Hopefully, a new government will peacefully evolve that will care for its peoples. And, hopefully, our leaders will come to their senses to assure that America will continue to move in the right direction to assure the welfare of its population, not just its corporate leaders and politicians, but us all.

Sunday, January 30, 2011

MUSIC REVIEW--THE NEW YORK PHILHARMONIC--Saturday Matinee--January 29, 2011

THE NEW YORK PHILHARMONIC
Alan Gilbert, Conductor;
With Sheryl Staples, violin; Robert Rinehart, viola; Ru-Pei Yeh, cello; Satoshi Okamoto, bass; and Philip Myers & Howard Wall, French horns.

Matinee Concert, January 29, 2011

Reviewed by Bill Breakstone, January 30, 2011

For those of you unfamiliar with the Philharmonic’s Saturday Matinee concerts, these are musical treats of the highest order. They feature a major work from the regular subscription concerts of the particular week, preceded by a chamber music work performed by first chair musicians and their associates from the Orchestra. This week’s program featured relatively unfamiliar compositions by Mozart and the Danish composer Carl Nielsen.

Mozart composed close to 100 divertimenti, serenades, noturni and cassations, mostly lighter fare written for outdoor musicales or indoor celebrations. However, four of these stand out as major compositions and contain serious music and length exceeding any of his symphonies. These are the Haffner and Posthorn Serenades, the Serenade for 13 Wind Instruments (Gran Partita) and the Divertimento in D Major for Two Horns and Strings, K.334/320b, performed at this concert.

This seldom-performed Divertimento is in 6 movements, is bright and cheerful, and contains a devilishly, fiendishly difficult part for the first violin, here brilliantly played by assistant concertmaster Sheryl Staples. Herbert von Karajan recorded this work with his Berlin Philharmonic back in the 1970s, using somewhat reduced string section, and that recording won high praise from critics for its lightness and transparency. However, the Divertimento was not written for an ensemble of 45 string players, but rather as a chamber work for 6,to which was added a double bass to support the horns. This septet version allows the listeners to clearly hear each part. The fifth movement is a minuet with two trios, the first of which is as lovely a musical idea as Mozart ever had.

After the intermission, the full Philharmonic took stage with their music director, Alan Gilbert, on the podium, for a performance of Carl Nielson’s Second Symphony (“The Four Temperaments”). This work had been performed only once by the Philharmonic, back in 1973, with Leonard Bernstein conducting. Although New York Times music critic Zachary Woolfe (never heard of him before!) dismissed the work alternately as “dull, relentless, slackening, meandering, and empty,” these ears found this symphony to be thoroughly engaging. It was quite unlike any romantic work I have encountered. The only leanings of another composer I could discern was of Bruckner, though Nielsen’s writing is far less heavy and without the massed brass found in most of Bruckner’s symphonies.

Gustav Mahler served as Music Director of the Philharmonic for two seasons shortly before his death in 1911. Mahler, as a composer, had an aversion to providing programs of his symphonies to critics and audiences, with the exception of his two earliest symphonies, No 1 (“Titan”) and No. 2 (“Resurrection”). His reasoning was to let the listeners form their own judgments of the composer’s intent. In this Nielsen Symphony, the dangers of programming are all the more evident. The four temperaments are labeled “collerico” (impetuous), “flemmatico” (phlegmatic, lazy, indolent), “malincolico” (melancholic) and “sanguineo” (boisterous, happy). With these four suggestions, the listener is predisposed to think along the lines of those titles while listening to the music. Yet such thoughts can be very much misleading. The first movement could just as easily be defined as energetic; the second movement, a leisurely waltz, as a relaxed dance; the third movement as a lush but somberly beautiful adagio; and the fourth movement as a happy march or jog.

In any case, this is a very interesting Symphony, expertly written and scored. Gilbert became quite familiar with Nielson’s works while acting as Music Director of the Royal Stockholm Philharmonic prior to his appointment here in New York. Thus his conception of this work bears a stamp of authority. And once again, the Philharmonic was sounding at its best in this orchestral showpiece. Thirty-seven years is too long an interval for the performance of this fascinating Symphony!

Monday, January 24, 2011

BOOK REVIEW--THE POSTMISTRESS by Sarah Blake

Reviewed by Bill Breakstone, January 24, 2011

A real estate colleague of mine recommended The Postmistress by Sarah Blake to me several weeks ago. This novel never appeared on the bestseller lists, for reasons I can’t understand. It was a terrific read! Kathryn Stockett, author of The Help, offered this compliment which appears on the dust jacket of the book: “Great books give you a feeling that you miss all day, until you finally get to crawl back inside those pages again. The Postmistress is one of those rare books. When I wasn’t reading it, I was thinking about it. It made me homesick for a time before I was even born. What’s remarkable, however, is how relevant the story is to our present-day times. A beautifully written, thought-provoking novel that I’m telling everyone I know to read.”

The relevancy of the story to today’s world I’ll address later.

This novel is about a world that I too had not yet been born into. The setting is in Cape Cod and the Europe of 1940 and 1941, before the United States entered World War II. London was enduring The Blitz; the Nazis in Germany, France, Poland and the Balkans were rounding up Jews. Hundreds of thousands of them were attempting to escape to the West, but Americans paid little attention to what Winston Churchill named “The Gathering Storm.” President Roosevelt had pledged that our boys would not be sent overseas to fight yet another war.

In the fictional Massachusetts town of Franklin on Cape Cod, in reality Provincetown at Lands End, Iris James is the postmaster of the local post office. Will Fitch is a recent graduate of Harvard Medical School and has assumed the responsibility of town doctor. He recently married young Emma Trask, and they listen on the radio to journalist Frankie Bard, an associate of Edward Murrow at CBS, broadcasting the horrors of The Blitz in London. Frankie’s roommate, Harriet, is a journalistic colleague who is focused on telling the story of the plight of European Jews that are being detained in “camps” in France. When Harriet is killed in one of the nightly bombings, Frankie takes up the task of bringing America’s attention to the oncoming holocaust.

Murrow dispatches Bard to Germany, France, Spain and Portugal, with a recorder to capture in words the story of what these European refugees are enduring. Before leaving London, Frankie meets Will in a bomb shelter, and when the all clear sounds the two emerge onto the London streets, where Will is struck down by a taxi, leaving a letter with Frankie to deliver back to his wife in the States.

The novel goes on to tell the story of all these people, and, more importantly, of the refusal of Americans to come to grips with the unfolding tragedy that is overtaking events in Europe.

As I read this beautifully written novel, I kept thinking about Kathryn Stockett’s compliments and what indeed she had in mind about the relevancy of the story to today’s times. What did she mean? Before Pearl Harbor, Americans were going about their daily lives, ignoring the world about them. What are we ignoring today? We are involved in two wars on the ground in Iraq and Afghanistan. Is that what Stockett is referring to? She doesn’t say, but I have my own personal view.

The people of today’s world are facing another Armageddon, but it is not one involving soldiers, guns, bullets and bombs. It is economic in nature, and consists of nation upon nation mired in debt, and a joblessness resulting from a financial catastrophe of epic proportions. Political constraints have thus far paralyzed world leaders from addressing what may become a crisis that will equal or exceed what the world endured during the Great Depression. There are voices out there, like Frankie’s, urging people to understand the consequences of inaction. Two New York Times journalists, one a Nobel Prize Winner, have continuously writing of their concerns about these two issues. Numerous books have also been written by award-winning authors. But is anyone listening, beyond his or her own parochial concerns?

Setting these political and economic thoughts aside, The Postmistress is a terrific story that grabs you and won’t let go!

Monday, January 17, 2011

MUSIC REVIEW--NEW YORK PHILHARMONIC ENSEMBLES AT MERKIN HALL--January 16, 2011

Reviewed by Bill Breakstone

This recital was the third in a series of five featuring leading instrumentalists of The Philharmonic. I am finding these programs to be a delightful source for the discovery of unfamiliar chamber works, performed by artists of the highest accomplishment. All three compositions on yesterday’s program were new to me, and some also new to the performing artists, one of whom I interviewed after the recital.

The opening work was the Trio for Violin, Cello and Piano, in G Major by Claude Debussy. Written in 1880, when the composer was 18 years old, this work was discovered in 1980 and is seldom performed. It is easy to see why. Debussy had yet to acquire his own, unique style, and the piece is more or less a piece of puff pastry, as my Austrian professor used to refer to music of little import but genial in nature. Of the three movements, only the finale, marked Appassionato, shows any seriousness, and contains some soaring melodies much in the vein of Faure.

The recital continued with the String Quartet No. 1, Op. 25, by Benjamin Britten, another youthful composition, but one bearing the stamp of a unique musical mind determined to create an individualistic style of his own. The first movement, marked Andante sostenuto—Allegro vivo, opens with the violins playing an eerie, high pitched dissonant melody, and then moves to an energetically pulsed allegro in the violins and viola, with the cello punctuating in pizzicato. The two themes play off against each other and the movement ends with a presto pizzicato coda. The Allegretto second movement is a strident march with the cello carrying the lyrical theme. The slow third movement Andante is in a minor mode and exhibits a wonderful development of the thematic material. The Quartet concludes with a molto vivace rondo in a major key, with the four instruments imitating each others theme, as in a “round.” There’s lots of humor, driving rhythms, an adagio interlude, then back to the main theme. This is a very interesting quartet, one which deserves a place in the performing repertoire.

After intermission, Frank Bridge’s String Quartet No. 1 in E minor was presented. Bridge, who lived from 1879 to 1941, was one of Britten’s composition teachers, was an accomplished violist, chamber musician, conductor, and composer. His works are seldom performed and are infused with a Brahmsian quality. Some hear shades of Faure within his music; I detected elements of Grieg. The first movement Adagio—Allegro is in sonata form and suffused with melody. The second movement Adagio molto is in a minor mode and astonishingly lyrical, with a most elegant second theme. The third movement, marked Allegretto grazioso, is a scherzo with a dance-like trio section. The work concludes with an Allegro Agitato—moderato molto in rondo form. Contrary to its markings, it begins with an adagietto theme, and then moves to the agitato section, alternating these two sections for the balance of the movement, ending with the cello repeating the main theme from the opening movement in a molto adagio pianissimo. This is a surprisingly beautiful quartet, a real find for musicians, and audiences, who are eager to try something new and fresh.

The playing by the Philharmonic instrumentalists throughout was masterful. Special note should go to violinist Fiona Simon, a Brit by birth, who lead both the Britten and Bridge Quartets from her first violinist chair.

BOOK REVIEW--HALF BROKE HORSES by Jeannette Walls

Reviewed by Bill Breakstone, January 17, 2011

Here is a wonderful little novel. Half Broke Horses is the story of Lilly Casey Smith and her family—her mother, Daisy Mae Casey; her father, Adam Casey; her sister Helen and brother Buster; her husband Big Jim Smith; their daughter Rosemarie and brother Little Jim. The two families were raised in Arizona and New Mexico in the early 1900s. They were dirt poor, but rich in heart, soul, smarts, savvy and perseverance.

Lily Casey is the central character. After having a fling at big city life in Chicago, where she was briefly married to a two-timing “crum bum” con man bigamist, Lily returns to her roots in Arizona. She meets Big Jim, and the two of them set out raising horses and cattle on a ranch near Flagstaff. The Great Depression wipes them out, but through luck and reputation, Jim is hired on to manage one of the largest ranches in Arizona, owned by investors from England. The land is high and dry, and lacks one crucial ingredient essential to making the ranch a successful operation—water. Big Jim and Lily solve that need with ingenuity, and they are off and running.

Lily learns early on that being a member of the fairer sex should be no impediment to living a full and worthwhile life. She becomes an accomplished horsewoman, a teacher, a college graduate, an aviator, as well as a gun toting mama that will put up with no nonsense from those trying to take advantage of her.

She and Jim have two children, a boy and a girl, who both love the open air, the horses, the cattle, and the ranching life. Rosemarie is an apple fallen from her mother’s tree—wild, sassy and unpredictable.

When war comes to Britain, the investors decide to sell the ranch to concentrate on war production back home. The family looses their beloved ranch before they can amass enough funds to buy a portion of it. They move to the big city, Phoenix, where they live for close to a decade in unhappiness, before returning to the wide open spaces in the northeast corner of the State.

The book is filled with adventure, tragedy, and lessons in life and living. It is simply written, but beautiful in that simplicity. Thus no wonder that is has remained on the best seller lists for close to two years.

I highly recommend it for a quick, leisurely read, akin to being on one of Lily’s horses and riding on forever through that beautiful high grazing pastureland that seems never to end.

Friday, January 14, 2011

COMMENTARY--THE POLITICS DIVIDING US

by Bill Breakstone, January 14, 2011


Paul Krugman, in his NY Times op-ed this morning, really gets down to the basics in the Nation’s political debate. He points out that despite President Obama’s call for renewed civility between the opposing sides of our ideological and political debate, America is a deeply divided Nation. He states:

“And the real challenge we face is not how to resolve our differences—something that won’t happen any time soon — but how to keep the expression of those differences within bounds.

What are the differences I’m talking about?

One side of American politics considers the modern welfare state —a private-enterprise economy, but one in which society’s winners are taxed to pay for a social safety net—morally superior to the capitalism we had before the New Deal. It’s only right, this side believes, for the affluent to help the less fortunate.

The other side believes that people have a right to keep what they earn, and that taxing them to support others, no matter how needy, amounts to theft. That’s what lies behind the modern right’s fondness for violent rhetoric: many activists on the right really do see taxes and regulation as tyrannical impositions on their liberty.”

Those differences are at the heart of the divide. Krugman is talking about a basic political philosophy. But the divide exists on more practical issues as well. One is directly related to the tragic events of last weekend in Tucson—gun control. On one side, there are those who cite the second amendment’s constitutional guarantee of the right to bear arms. They defend that right with the certitude that it means life or death for American liberties. On the other side are those who argue that second amendment rights must be tempered by the advanced weapon technologies and mental instability of so many people in this modern age. They point out the numerous mass killings that have occurred in America over the past decade and ask “how many more innocent lives must be sacrificed in order to insure a constitutional right that was written into our Constitution over 200 years ago, at a time when such weapons did not exist?”

Krugman boils the issue down to another key element which is hotly debated among our populace—the role of government in regulating the society. He sees one side taking the position that “much of what the modern federal government does is illegitimate; the other side does not.”

He then compares our divisive politics to the debate over abortion rights:

“In a way, politics as a whole now resembles the longstanding politics of abortion—a subject that puts fundamental values at odds, in which each side believes that the other side is morally in the wrong. Almost 38 years have passed since Roe v. Wade, and this dispute is no closer to resolution.

Yet we have, for the most part, managed to agree on certain ground rules in the abortion controversy: it’s acceptable to express your opinion and to criticize the other side, but it’s not acceptable either to engage in violence or to encourage others to do so.

What we need now is an extension of those ground rules to the wider national debate. . . . . . We need to have leaders of both parties—or Mr. Obama alone if necessary—declare that both violence and any language hinting at the acceptability of violence are out of bounds. We all want reconciliation, but the road to that goal begins with an agreement that our differences will be settled by the rule of law.”

All well and true, but there is a dire need for things to change less the tragedies are to be repeated again and again. And more than attitudes need changing. Though one side abhors governmental regulations, how are we to prevent Tucson from happening again without them?

Thursday, January 13, 2011

BOOK REVIEW--"DEAD OR ALIVE" by Tom Clancy

Reviewed by Bill Breakstone, January 12, 2011

Tom Clancy’s latest novel, “Dead or Alive,” is a 950-page monster, his 14th in a series that began with his classic “Hunt for Red October,” published way back in 1984. I’ve read 13 of these books, all but “Teeth of the Tiger,” and enjoyed them all. My last Clancy read was in 2000, thus it was a pleasure to return to most of the old characters, with a few new ones tossed in.

Dead or Alive is a complicated, many-layered tale of terrorism and the intelligence efforts to thwart a plot that if successful would send the United States back to the dark ages.

The terrorists are led by The Emir, a Saudi Arabian by birth, and a direct duplicate of our own Osama bin Laden. He has formulated plans to strike at six international targets, the final masterstroke being a nuclear attack on a facility near the West Coast.

Working to solve this complicated terrorist puzzle are the personnel of “The Campus,” a compilation of clandestine intelligence assets organized by former President Jack Ryan, to which his former spooks John Clark and Domingo Chavez have recently been recruited. Also on board is Ryan’s son, Jack, Jr, who has inherited all of his father’s intuition and skills in the intelligence community.

Despite its massive size, Dead or Alive is a fast and thrilling read, though perhaps not for those squeamish at heart. There is violence galore, chases, counterplots, and tales of tragedy and courage. And, there will no doubt be a sequel, which will be more political in nature. Now that is something to look forward to!

Sunday, January 9, 2011

COMMENTARY--WHY IS JOB CREATION STILL LAGGING WHILE CORPORATE EARNINGS ARE SOARING?

by Bill Breakstone, January 9, 2011


Today’s New York Times Week In Review Section carries an intriguing article by Michael Powell addressing the question posed in the title of this Commentary. The entire article is well worth a read. Here are some highlights:


“To gaze upon the world of American corporations is to see a sunny place of terrific profits and princely bonuses. American businesses reported that third-quarter profits in 2010 rose at an annual rate of $1.659 trillion, the steepest annual surge since officials began tracking such matters 60 years ago. It was the seventh consecutive quarter in which corporate profits climbed.

Staring at such balance sheets, you might almost forget that much of the nation lives under slate-gray fiscal skies, a place of 9.4 percent unemployment and record levels of foreclosures and indebtedness.

And therein lies the enduring mystery of this Great Recession and Not So Great Recovery: Why have corporate profits (and that market thermometer, the Dow) spiked even as 15 million Americans remain mired in unemployment, a number without precedent since the Great Depression? Employment tends to lag a touch behind profit growth, but history offers few parallels to what is happening today.

“Usually the business cycle is a rising-and-falling, all-boats-together phenomenon,” noted J. Bradford DeLong, an economics professor at the University of California, Berkeley, and a deputy assistant secretary for economic policy in the Clinton Treasury Department. “It’s quite a puzzle when you have this disjunction between profits on the one hand and unemployment.”

A search for answers leads in several directions. The bulls’ explanation, heard with more frequency these days, has the virtue of being straightforward: corporate profits are the economy’s pressure cooker, building and building toward an explosive burst that will lead to much hiring next year.

The December jobs numbers suggest that that moment has yet to arrive, as the nation added just 103,000 jobs, or less than the number needed to keep pace with population growth. The leisure industry and hospitals accounted for 83,000 jobs; large corporations added a tiny fraction.

But relatively few economists, even those who see signs of an improving economy, sound particularly buoyant, a concern shared by liberals and conservatives alike. Jobless recoveries followed on the heels of the last two recessions, but neither prefigured the depth of the trouble this time. After the 1990-91 recession, it took 23 months to add back the jobs lost. After the 2001 recession, it took 38 months. (And it’s worth keeping in mind that one of the great housing and credit bubbles in American history fed that hiring; no economist expects that to repeat itself).
At the current rate, the economy will need 72 to 90 months to recapture the jobs lost during the Great Recession. And that does not account for the five million jobs needed to keep pace with a growing population.

None of this has slowed the unprecedented rise in corporate profits. The reasons are many.

Many American-based corporations earn a great portion of their profits overseas. And thanks to porous tax laws, these companies return fewer of those profits to American shores than in the past.

“The big American companies are really global,” said Robert Reich, former labor secretary for President Clinton. “They can show big profits from foreign sales. G.M. is making more Buicks overseas than in the United States. There’s no special pop for the United States worker.”

Key corporate sectors, too, have undergone a Darwinian pruning during the last three years. In the financial arena, a few hyper profitable firms now stand where many more once stood.

“If you’re Goldman and Morgan Chase, and you once had to compete against Bear Stearns and Merrill Lynch, well, of course it’s easier now to show a profit,” said Daniel Alpert, managing partner of Westwood Capital L.L.C., an investment banking firm. “If you have a modest reduction in expenses, and an industry consolidation at the same time, that translates into a massive increase in earnings.”
Surviving corporate leaders drew sobering lessons from their near-death experience of 2008 and 2009, when brand-name corporations nearly ran short of the cash needed to meet payrolls.

“They found the financial system was nowhere near as safe as they thought — they no longer think they can borrow as quickly,” said Simon H. Johnson, an economics professor at M.I.T. and former chief economist for the International Monetary Fund. “So the amount of cash that they think they should have for precautionary purposes is way up.”

Desmond Lachman, a former managing director at Salomon Smith Barney who now serves as a scholar at the American Enterprise Institute, a conservative policy center, sees corporate leaders reshaping their worlds.

“Corporations are taking huge advantage of the slack in the labor market — they are in a very strong position and workers are in a very weak position,” he said. “They are using that bargaining power to cut benefits and wages, and to shorten hours.” That strategy, Mr. Lachman said, serves corporate and shareholder imperatives, but “very much jeopardizes our chances of experiencing a real recovery.”
He’s not terribly impressed. Profits for these companies “repeatedly topped 12 percent in the 1950s and 1960s,” he writes. But in the third quarter of 2010, this sector’s share of national income stood at 7.03 percent.

Market bulls applauded in November when the Conference Board revealed that consumer confidence was on the rise. But David Rosenberg, an economist at the investment firm Gluskin Sheff, noted that this increase owed entirely to the optimism of higher-income Americans, who are feeling better and better.

The housing market, by contrast, created millions of middle-class jobs and accounted for much of the wealth creation of the past decade. But that sector remains nearly comatose.

“I don’t see a pop in corporate hiring, because why should they hurry?” said Professor Johnson, the former International Monetary Fund economist. “They are paying themselves well and with demand so low, they don’t feel they are missing out on anything.”


What does all this mean? The Obama Administration and the Federal Reserve deny that our unemployment problems have become structural. However, if it is going to take 7-1/2 years before the unemployment rate reaches an acceptable number, near full-employment, these denials do not ring true.

Friday, January 7, 2011

COMMENTARY--A LICENSE TO STEAL

by Bill Breakstone, January 7, 2011


The drug colchicine has been in use as a treatment for gout “flare ups” for over 50 years. Its entry into the drug market predated the establishment of the Food and Drug Administration; thus colchicine existed as an unapproved product, not a generic drug.

In July of 2009, the drug company URL Pharma, a division of AR Scientific, Inc., received formal approval from the FDA for their drug “Colcrys.” I have a bottle of this drug, and the label indicates that its only ingredient is “colchicine.”

During the first week of October 2010, the FDA announced that it was ordering unapproved colchizine products off the market, and that it was granting exclusivity to URL Pharma’s Colcrys for a three year period, commencing on January 1, 2011.

The Senior Editor of the online news service MedPage Today, John Gever, wrote the following on October 6, 2010:


“With last week's announcement by the FDA that it was ordering unapproved colchicine products off the market, the year-old debate over the agency's handling of the popular gout treatment has flared anew.

The wisdom of granting periods of marketing exclusivity to the maker of Colcrys, the sole approved form of colchicine, was debated in the letters section of the Oct. 7 issue of the New England Journal of Medicine by two top FDA officials and two physicians at Brigham and Women's Hospital in Boston.

And the American College of Rheumatology (ACR) reiterated concerns first expressed in 2009 about price hikes associated with the approval of Colcrys and the impending removal of much cheaper unbranded colchicine products.

The FDA's action against the unapproved products has been expected since URL Pharma received formal approval of Colcrys in July 2009.

At the time, the FDA indicated that makers of other, unapproved colchicine products would either have to submit marketing applications or take their products off the market. It cited a decades-old policy requiring that the safety and efficacy of drugs that were on the market in the 1950s, when the agency won full authority to regulate them, would eventually have to be proven. There were dozens of such drugs, including colchicine.

That requirement was largely ignored until 2006, when the FDA began to crack down on some of these "grandfathered" drugs, such as hydrocodone-containing cough syrups.

Under the stricter policy adopted in 2006 and backed up by legislation enacted by Congress, the agency indicated that it would provide incentives for companies to submit marketing applications for drugs in the targeted classes.

Specifically, the FDA would grant three years of marketing exclusivity to the first company to receive a formal approval, or seven years if the drug was for an orphan disease.

The agency also indicated in a guidance document that it would ordinarily wait one year after granting an approval before taking action against unapproved products. That, the FDA argued, would give their manufacturers a chance to submit their own applications or take steps to wind down production and inform customers in an orderly way.

In June, Aaron Kesselheim, MD, and Daniel H. Solomon, MD, published a letter in the NEJM berating the FDA for the negative impact that patients with gout and familial Mediterranean fever would suffer as a result of this policy as applied to colchicines. Colcrys has three years of exclusivity in treatment of acute gout flares and seven years for familial Mediterranean fever, an orphan disease. The drug is also approved for preventing flares, with no exclusivity. Whereas the unapproved products cost around 10 cents a pill, Colcrys comes with a sticker price of nearly $5a pill, Kesselheim and Solomon wrote."


I personally have plenty of experience with both gout as a disease and drugs that are used in treatment thereof, a malady that I have suffered from for the past ten years. I have taken up to this point two medications: colchicine and allopuranol, and since beginning the course of using both of these drugs, have not suffered one flare up of gout.

However, when I ordered a refill of colchicine the other day, the pharmacist informed me that the drug had been “pulled” by the FDA and that she would substitute the new FDA approved medication. When I noticed the price thereof, I went through the roof! Colchecine had cost me roughly $5.00 per refill. This new medication, Colcrys, ran me $82.00!

The FDA denies any responsibility for the pricing or cost of any of its approved medications. They maintain their sole responsibility is insuring the safety of the products it approves. They also claim that the enabling legislation regarding its “crackdown” on unapproved substances put them in the proverbial straight jacket. This argument is pure bunk. If the effect of granting exclusivity to a drug company is to increase the cost of a bottle from $9.00 to $485.00, what the FDA has done is issue a license to steal from the consumer, who faced with such outrageous costs, will forego a medication that had proved effective, safe, and affordable if used as instructed by physicians.

Letters will be going out to Senators Schumer and Gillibrand post haste.

For more information on this subject, see: (1) FDA New Release of September 30, 2010; (2) Letter from Drs. Kesselheim and Solomon to the FDA published in the June 2010 Issue of the New England Journal of Medicine; (3) Letter to Drs. Kesselheim and Solomon from Dr. Janet Woodcock of the U.S. Department of Health and Human Services dated March 3, 2010; (4) New York Times article “Purging the Pharmacy of Unapproved Drugs” by Natasha Singer dated March 26, 2010; and (5) MedPage Today article “Controversy Over Colchicine Price Hikes” by John Gever dated October 6, 2010.

Tuesday, January 4, 2011

BOOK REVIEW--"Port Mortuary" by Patricia Cromwell

Reviewed by Bill Breakstone, January 3, 2011

Port Mortuary is the latest novel in the Kay Scarpetta Series by Patricia Cromwell. The title refers to the Medical Examiner’s Office that receives (thus “port”) and autopsies victims of fatal accidents, natural deaths, combat mortalities (in the case of military “ports”, such as the one located at Dover Air Force Base in Delaware), and homicides. Scarpetta fans will not be disappointed by this latest installment, though I found it to be not among Cromwell’s best efforts.

The plot is complicated in the extreme, though not difficult to follow. The regular cast of characters is all present: Kay; her niece Lucy; her husband Benton Wesley; her old sidekick Pete Marino; and her assistant chief Jack Fielding. The literary problem is that they are all getting to be old hat, their actions and attitudes all too familiar and expected after approximately eight Scarpetta novels.

The crimes involved are centered around nanotechnology being developed by an experimental Boston-area laboratory that is partially funded by the United States government and military, and whose employees include scientific geniuses from nearby Harvard University and MIT. However, it is not until the last 75 pages of the novel that the true identity of the killer is revealed, and by that point any theories the reader may have of what’s behind the killings is blown out of the water.

My other objection is that the book is just too wordy, and the action almost non-existent. There is too much psychological analysis of the principal heroes and not enough narrative dealing with the crimes themselves. When the climax is reached near the end of the novel, it is too abrupt and lacking in narrative explaining the motivation of the killer.

All that being said, it was an enjoyable read, though the ending proved a major disappointment to this reader.

Sunday, January 2, 2011

BOOK REVIEW--"Safe Haven" by Nicholas Sparks

Reviewed by Bill Breakstone, December 31, 2011


I picked up a copy of Nicholas Sparks’ new novel “Safe Haven” the other day. I had read two of his previous books and watched the latest movie adaptation of his “Last Song,” and found them all entertaining. When a literary friend asked me what I’m currently reading, I told her the latest Sparks novel. She asked me why I’m wasting my time reading such inconsequential writing, I said because it’s fun, and that we can’t always be absorbed with serious literature.

And fun is what this novel is all about. Sparks tells a good story, if not on the level of a John Grisham, and he tends too often to mix in a little of the supernatural, when it is not at all needed.

This tale is set in a small town in rural North Carolina, about three hours southeast of Raleigh. Alex Wheatley is a thirty-something- year-old widower, a father of two delightful young children, and the proprietor of a country store/restaurant/gas station who has his hands full between the kids and the business. Katie Feldman is a recent arrival from up north, a secretive but very attractive 29-year-old. The four become close friends, eventually entering a serious relationship. Katie has a disturbing past, including a marriage to an abusive husband from whom she has fled.

The novel details the developing trust between Alex, Katie, and the two children, and the consequences of Katie’s previous marriage. No need to divulge any more than these few glimpses of the story line, except to say that the book is more than a romance novel, and that it evolves into a real thriller.

I enjoyed the read very much. It was a pleasant diversion from government, economics and literary fiction. Just a good fun read. I heartily recommend it.