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January 2008

USS Theodore Roosevelt

Part of being in the President’s Cabinet is becoming acquainted with the broader mission of the government. I accepted an invitation to spend part of the weekend with the Navy aboard the USS Theodore Roosevelt, a nuclear-class aircraft carrier, as it conducted training off the eastern seaboard of the United States.

I spent time with the ship’s commanding officer as well as the Commander of the Second Fleet and the battle group of which the TR is a part. An aggressive schedule allowed me to get a first-hand look at each of the sub-divisions of the ship and its operation. I came away with a much better understanding of the Navy’s mission and the way it integrates into the armed forces of the United States.

The ship was conducting flight qualification for pilots of various squadrons attached to the Second Fleet. Before pilots can be deployed, they have to demonstrate competency in landing on and taking off from an aircraft carrier. On display was world-class science, engineering, logistics, and management.

Hour after hour, planes took off and then landed on the deck of the ship. To take off, an aircraft is hooked to a catapult which uses steam pressure and hydraulics to sling the plane into the air. In less than two seconds, it reaches 150 miles an hour. The pilot has the engines at full throttle so the engines take over where the catapult leaves off.

Most people have seen pictures on television or movies of this procedure but what is not evident is the electrifying energy and thundering sounds surrounding the operation. Standing a few feet away, I could feel my body vibrate on the inside. It is the kind of force so overpowering that a feeling of smallness overtakes you. However, the reality of all that steel and the flaming explosiveness of the jet fuel somehow blends with the controlled and methodical motion of the crews. They move with robotic precision over and over.

The landings are even more remarkable to me. Standing on the deck about 50 feet from their touch point, I could see the aircraft approaching. The closer they came, the more evident their speed became. They are flying at about 150 miles an hour when they cross the trailing deck of the ship. The planes wiggle back and forth as the pilots struggle to position them at exactly the right altitude and angle.

I watched dozens of landings, and every single one gave me the same feeling one gets when they see an accident about to happen. There is an explosive sound of the jet engines at full bore, and then the collision of sixty thousand pounds of steel hitting the deck of a ship. For a split second you wonder: is it going to stop? Then the plane snaps to a halt, even rolling backwards a few yards. And then suddenly, quiet, as the plane calmly follows the directions of the crew to a parking spot.

All of this was dramatic in the daylight, but when night came, the impact racketed up several notches. Then add driving rain and the full specter of our Navy’s competency came to view; they just continued to work through it all.

Speaking of competency; I admire how competency-oriented the military is. The amount of time you spend in flight school is not the final determinant of your ability to fly. It is the demonstrated ability to land and take off in all kinds of situations. Nobody is considered combat-ready until they are proven as such. Every landing is graded, every move evaluated. If you don’t prove it today, go back and get better and try again later. Our schools should be more like that.

Many of those we watched being tested had never landed on a carrier before. Most of the pilots I talked with agreed, it was adventurous in the daylight but far closer to frightening at night.

I had my own experience with both landing and taking off. We were flown to the carrier on a C2. It is a plane built to be adaptable for passengers or cargo. We were strapped into our seats facing backwards on the landing. I would describe the landing as violent, jarring and frankly a little nauseating, but everything other than the nausea was over in less than two seconds. The catapult off the ship was far closer to a great amusement ride, but still only lasting about 2 seconds.

They refer to the USS Theodore Roosevelt as the Big Stick, referencing Teddy’s slogan, “speak softly and carry a big stick.” Much of the 27 hours I was there was spent climbing steep stairway ladders that connect nine layers of the ship where people live and work. The ship is a small industrial city with a population of 5,500. The place is permeated with uniquely Navy culture where everybody knows their job and goes about doing it.

Like any city, there is a post office, a hospital, places to shop, and eat. There are recreation opportunities, residential areas, offices and highly industrialized sections. Every part of the ship is defined by the equivalent of an address; otherwise, one would get hopelessly lost in the maze of tunnel like halls, hatches and ladder stairs.

The food was good; the sailors polite; the quarters were suitable, though the constant roar of jet engines and ship-rattling thud of jets landing on the deck took some getting use to. They say sailors learn to ignore it. Fortunately, they quit flying about midnight and I slept quite well on the lower level of a three-man bunk with 15 inches of clearance between my nose and the next one up.

Though all the machinery was marvelous, I was told it would be the people that impressed me the most and it was. All the senior officers I met were remarkable. I’ve concluded if a person survives 25 or more years in the “up or out” system of the United States Navy, you are an exceptional person. That is certainly true of Captain Ladd Wheeler and his Executive Officer, Greg Fenton. Captain Fenton told me over dinner he had 800 take-offs and landings on aircraft carriers.

I had breakfast with Command Master Chief Chris Engles. He pointed out to me, several times during the visit, that most of those doing the work on board were young, many 18 and 19 years old. They are the products of a system of discipline, training and leadership that demands and gets competency and performance from young inexperienced people, many of whom are away from home for the first time. As we ate breakfast and talked, it became clear to me he cares a great deal about them because that is exactly where he came from.

Engles was born in a row-house neighborhood of central Baltimore as the second child in an Irish-Catholic family of seven. His mother was a 4-foot 10-inch, red-haired, stay-at-home mother. His father is a large gentle Irishman who worked at the shipyards.

A few minutes of conversation with Chris reveal a natively smart man. He speaks with a clipped rapid cadence of the tough neighborhood he grew up in. Talking together I could visualize a 17-year-old who dropped out of high school because he was bored and started working for a buck an hour moving furniture. By his own description, Chris was wasting himself and said he needed something better.

His father had been in the Navy. It had always been a source of pride for his family. In fact, they kept his father’s Navy neckerchief tied to the mirror of the car as a reminder of those days. One afternoon Chris saw a recruiting office and within a few months he was a sailor.

A year or two later he had married the daughter of one of his Naval superiors whom he had met at the christening of a ship he later served on. They have now been married 25 years and have two children, one of whom is in the Air Force.

Chris Engles appears to have been made for the Navy. Smart, disciplined and knows how to talk to everyone. He’s now one of the highest ranking non-commissioned people in the Navy. The Navy has given him education, opportunity and leadership. He has given the Navy his devotion, energy, and lots of sacrifice. He’s a great example for those 18 and 19-year-olds who shoulder so much responsibility and he’s undoubtedly one of the reasons the system works so well.

It also makes one remarkably proud of the armed forces of the United States.

Thoughts On Your Comments

I’m sitting at my desk with a  bowl of soup for lunch.  I have 30  minutes and I’m thinking this might be a good time to respond to a few comments  you have sent. 

First, let me say, I do read the  comments. I just have a hard time finding the time to respond and make new  postings too.  So, I tend to concentrate  on new postings.

Comment on Guatemala  Inauguration
On January 18,  Science Teacher wrote:
Can you tell us whether the topic of H5N1 came up  with any of the representatives of Latin American countries? Is there concern?

Response:
I was  in Central America about a year ago working on  Pandemic issues with the health Ministers.   We have helped them build lab capacity and actually trained more than  200 people from Central America on pandemic  related issues.  It is not a top of mind  issue there, and they still have a ways to go on public health infrastructure.  Gratefully, we haven’t seen any H5N1 positive birds in that part of the world.

Comment on Guatemala  Inauguration
On  January 22, David A. Haley wrote:
Instead of talking about "safe" topics such as India or Guatemala, why don't you address  meaningful topics to the American people, such as what efforts you and the  Administration are undertaking to fix our healthcare system? Hello. Is anyone  home in Washington?

Response:
David, you are right in saying my writings have been fairly  heavily oriented to international work lately. I think if you look back in past  postings I have written about many different topics that fit the criteria you  lay out.  The concentration of recent  writings on international work reflects the fact that I traveled fairly heavily  while Congress was out of session.   International work is an important part of my work and it has a direct  reflection on the health of the Americas.  The safety  of imports is an example. Most of my time in India was focused on products  Americans consume. 

I should also confess that I use this blog as a way to keep track  of what I learn on these trips as a journal of sorts. 

I encourage you to keep reading as there will be lots of meaty  issues to discuss.

Comment on Day 5 in India
On January 17m Robins Tomar wrote:
It would be great if you could write one more post about your  overall experience, changes in feelings before and after your visit and some  recommendations from your experience.

This is just a request if you get time from your busy schedule.  Anyway I will be following your blog to know your opinions about what is  happening around us.

Response:
I would say one of the most of the most important changes in my  feelings were the kind of things that come when one actually sees a place  rather than reflecting what you have heard or read.

Here are just a couple of examples:

  • It is hard to adequately explain the challenges of population as large as India’s and how it impacts every public policy issue.         
  • I’m attracted to the people of India.  I have lots of friends in the U.S. of Indian heritage and seeing India created a new context for our relationship.
    In Utah there  is a community of people with roots in India.  They have become prominent in academic and  financial circles.  As governor, I was  often invited to attend their celebrations and events.  I always admired the way they worked to  preserve their connection to an ancestral home even though many of them have  become major successes in the U.S.  Now that I have seen that home, it is easier for me to understand their view of America and India.   
  • I found particularly helpful the understanding I gained of the small farmers in India and their political influence.  I wrote some about this in one of my postings.
  • The number and size of the drug and vaccine manufacturing facilities in India requiring FDA attention was an important actualization.
  • The intellectual connection between the U.S. and India came as a pleasant surprise.  I knew it       existed but didn’t have a sense of scale.

I could go on and on, but this will give you a small sense of what the trip did for me.


Comment on Electronic Medical  Records and the Medicare Sustainable Growth Rate
On December 3, Chris Farley wrote:
The US  government/we the people already own an excellent EHR - the VA's VistA system. It is fast, simple to use, incredibly  stable and a large portion of the work needed to make it viable in private  practice is already done. Two organizations have taken it,  "de-veteranized" it and gotten it CCHIT certified. With a small  fraction of that cost, the system could be fully upgraded and modified to meet  all of the needs of the commercial market-place and fully implement the quality  measures and disease registries necessary to adopt pay for performance and  improve the quality and lower the cost of healthcare

Response:
I am a big admirer of VISTA and  the Veterans Administration.  In fact, I  borrowed the National Coordinator of HIT from the VA, Dr. Rob Kolodner.  The problem comes in creating compatibility  between other systems and the VA because most patients, even in the VA system, deal  with multiple providers outside their system.   We need to achieve interoperability.   As you point out, there are some providers who are using the VA system  as a foundation to develop smaller systems and we welcome that.  This answer is short but in the press of  time, I’ll leave it at that.

Comment on Electronic Medical  Records and the Medicare Sustainable Growth Rate
On December 3, Chris Farley wrote:
It is very easy for the Sec of HHS to say that Electronic records  are the answer to rising Medicare costs. It is very short-sighted to ignore the  reality that the numbers of the Medicare-eligible are increasing every month.  Besides, with increased litigiousness of society, has the HHS conducted an  objective study of what percentage of procedures physicians carry out are just  to protect themselves against frivolous law suits?

Response:
There are a number of studies that document the practice of defensive  medicine.  I would support reforms that would  minimize the practice or perceived need.   Many believe that the development of best practice quality measures will  provide some protection.

Comment on Electronic Medical Records  and the Medicare Sustainable Growth Rate
On December 3, Chris Farley wrote:
While agreeing that the current formula is an utter failure, I  would like to point out that Physicians are now working at 2005 reimbursement  levels (far from keeping pace with inflation). The moral of this horror story  is that if professionals are paid their legitimate dues, they will not abuse  the system. It is useful to remember that neither the gas nor electricity  prices; employee salaries nor office rent; neither liability premiums nor cost  of EMRs have stayed at 2005 levels - unlike Medicare payments under this  convoluted SGR formula. I have yet to see any effort by Medicare or any other payee  to actually interact with practices that have had extensive experience with EMRs  to identify real world solutions to real world problems. Until that happens, it  will be unreasonable for Mr. Leavitt to expect physician practices to  voluntarily adopt Electronic records. So if HHS would like to push this idea,  let there be a level playing field and objectivity in assessment of its impact.

Response:
I stand by my belief that the system doesn’t work well.  You would be amazed at the amount of work  Medicare does to estimate what things cost for doctors and therefore what the  reimbursements should be.  The truth is, command  and control regulator systems rarely get it right.  A well informed marketplace where consumers  have information on quality and price will both make the relationship between  doctor cost and charges far fairer.

In a previous entry, I talked about walking through a grocery  warehouse with 50,000 items and asked the manager what would happen if the  government started setting prices on every item.  His answer was right, in my view: “fewer  products, higher cost, and continual arguments.”  I told him, he had just described Medicare  reimbursement.


Well, the soup is gone and my time is up so I’ll conclude and post.

 

Health Information Technology (Written January 22, 2008)

Most readers of this blog won’t get all goose-pimply when I report Tuesday as an important day in the world of health information technology. However, what happened in the 19th meeting of the American Health Information Community (AHIC) will ultimately affect the way all of us interact with medical providers.

At the AHIC meeting a series of significant steps were recommended that will advance the interoperability of health information systems. We moved a step closer to delivering the promise of health information technology -- lower costs, better quality and more convenience for patients.

For those who follow this subject, and other readers willing to learn some about it, I’m going to link this entry to three things:

• First, a short speech I gave at AHIC putting the day’s events into to perspective.

• Second, a press release discussing HHS awarding a contract to design the permanent successor organization to AHIC and a Web site were you can find more information about this.

• Lastly, another press release which tells of AHIC’s acceptance of new standard recommendations on interoperability.

Notes on Martin Luther King Jr. (Written January 21, 2008)

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I’m a James Taylor fan. His music speaks to me musically and  emotionally.  The first verse of a song  he wrote, Shed a Little Light, has  been on my mind today.

Let us turn our thoughts today
  To Martin Luther King
  And recognize that there are ties between us
  All men and women
  Living on the earth
  Ties of hope and love
  Sister and brotherhood
  That we are bound together
  In our desire to see the world become
  A place in which our children
  Can grow free and strong
  We are bound together
  By the task that stands before us
  And the road that lies ahead
  We are bound and we are bound

So, on this Martin Luther King Jr. Day, I want to do just  that: “...turn (my) thoughts to Martin Luther King...”  I have had several experiences that have  caused me to hold a deep sense of reverence for him.

In the late 1990s, while Governor of Utah; I was seated next to Coretta Scott King, Dr. King’s widow, at a dinner in Washington D.C. Our  conversation evolved from casual dinner chat to a rather long and searching  philosophic discussion about Dr. King’s life and the mission it thrust upon  her.  It was a uniquely personal conversation and rather than divulge the details, I wish to only recount the  gift I felt she gave me that night.  I felt like I had seen a little bit of her soul and it was moving to me. 

A few days later she sent me a book about Dr. King.  Reading it in the aftermath of our  conversation was a delightful experience that left me feeling a real admiration for both of them. 

In late 2005 and early 2006, I traveled extensively, meeting  with community organizations that were helping to enroll seniors in the new  prescription drug program.  On three occasions, I visited the Ebenezer Baptist Church  in Atlanta, Georgia, where Martin Luther King Jr. spent much of his life.  I met leaders of  the church and community in the basement of the old church and later was invited to speak at the Sunday services.  The experience heightened the impact of my conversation with Mrs. King  and the reading of Dr. King’s book. 

That year I had another experience which added to the  picture I hold of Dr. King’s life.  I met  Dr. Samuel “Billy” Kyles, a respected Pastor in Memphis who was with Dr. King when the civil  rights leader was assassinated.  They  were going to Dr. Kyle’s home for dinner.

I’m sure Dr. Kyles has told the story hundreds of times since then.  However, when I heard the details  in such a personal and direct way, it left no uncertain impact.  It was a tragic turn of events, but like other martyrs who sealed their mission with blood, Dr. Martin Luther King Jr.’s  death punctuated and assured that the message of his life will never be forgotten.  (Here’s a link to a speech  Dr. Kyles gave telling the story – it’s worth reading:  http://www.explorefaith.org/LentenHomily04.03.00.html 

The second verse of the James Taylor song continues:

There is a feeling like the clenching of a fist
  There is a hunger in the center of the chest
  There is a passage through the darkness and the mist
  And though the body sleeps the heart will never rest
 
  Oh, let us turn our thoughts today
  To Martin Luther King
  And recognize that there are ties between us
  All men and women
  Living on the earth
  Ties of hope and love
  Sister and brotherhood

Guatemala Inauguration (Written January 15, 2008)

The inauguration  of a new president is a major historical milestone for any nation. Inaugurations  have attributes that resemble a wedding. 

The steps  leading up to the inaugural are similar.   There has been a courting period and proposal from competing suitors, a  decision, and then an engagement period or transition as we call it in  government. Finally, the ceremony where oaths are said finalizing long-contemplated  promises with legal authority used to seal them.

The ceremony and  ritual of a wedding or inauguration underscores the importance and seriousness  of the commitments being made.  Friends  gather to show support and respect for what is occurring. There are social dynamics  to both.  Who participates, who gets invited,  and where they sit is closely watched. Care is taken to assure that the second  spouse of a divorced parent is seated in a place that avoids tension. There are  parties held in celebration.

Monday, January  14, Alavaro Colom was inaugurated as the President of Guatemala.  President Bush assigned me to lead a  delegation to attend the festivities as a demonstration of the value our nation  places on our friendship with Guatemala.  The other members of our delegation included:

James M. Derham
  Ambassador to Guatemala

Rob Mosbacher
  President of the  Overseas Private Investment Corporation

Sara Martinez  Tucker
  Under Secretary  of the Department of Education

Christopher A.  Padilla
  Under Secretary  of the Department of Commerce

In Latin America, inaugurations are major convenings for heads  of state.  Presidents of more than a  dozen nations, mostly from the region attended.   That makes the day of the inauguration an opportunity for a lot of  business to be conducted in an efficient way. 

After my arrival  the night before, I carried the greeting of our President to outgoing President  Berger. We met at La Casa Presidential, the equivalent of our White House. 

This is the  second occasion I have represented the United States at an  inauguration.  A year ago I lead a  delegation to Nicaragua  when Daniel Ortega took office.  I have  found these meetings with outgoing Presidents fascinating.  It is a period of great reflection for them.  President Berger and his Vice President and  Foreign Minister were there.  We spoke of  lessons he has learned, things he is proud of.

Prominent on  President Berger’s list of important accomplishments is a democracy able to  transition in a fair and democratic fashion.   Twenty years ago Guatemala  was in crisis. He is right — it is a significant accomplishment.   

Early Tuesday  morning, our delegation met for an hour and 15 minutes with President-elect  Colom, Vice President-elect Rafael Espanda, and the new Ministers of Health and  Foreign Affairs, and Economy.  We got  better acquainted and spoke in specific terms about a number of common  interests. 

The significance  was not lost that the President would spend that much time with representatives  of the United States  on such a significant day. 

The new Vice  President of Guatemala is Refael Espada.   He has been a surgeon in Houston for the  last 30 years but each month he has returned to Guatemala to do surgery.  A year ago, he moved back to participate in  the election. He is not a politically experienced man, but has an enormous  amount to offer his country. 

The balance of  the morning was spent meeting with other heads of state.  I had 30-minute meetings with the Presidents  of Panama, El Salvador, Honduras,  and Nicaragua.  The meetings were each a little different mix  of issues.  I have spent a lot of time in  Central America the past couple of years and  have developed good working relationships with each of them. 

Late in the  morning I had a good meeting with the Mexican Minister of Health. We have an  ongoing series of issues we work together on:  border issues, product safety, disease  surveillance, etc.  We reviewed our  shared portfolio, setting some follow-up meetings for February and March, 2008.

Lunch was at the  Ambassador’s residence where we met with the other Ministers of the new  Guatemalan government.  We then traveled  to the swearing in ceremony at Centro Cultural Miguel Angel Asturias, a large  hall in Guatemala City. 

The heads of  state were seated on the front row.   Because the U.S.  delegation was headed by a non-head of state, my place was right behind the  various Presidents.  It was a great spot  to watch the interaction between various people.  Care had been taken to seat Hugo Chavez a  fair distance from a couple of people with whom he had well-published dust ups.  He was next to Daniel Ortega.

The President of  Taiwan was there with a delegation of nearly 100 people.  They flew in on over a hundred people in a  747 owned by China Airlines.  Guatemala is one of a small group of countries  which recognize Taiwan  as a nation. 

The ceremony to  transition power was conducted in a rather dignified way, I thought.  In Central America  the primary emblem of power is a colorful sash draped over the right shoulder  of the President.  The outgoing President  removes the sash and gives it ceremoniously to the Speaker of their legislative  body.  The Speaker then announces the  results of the election and calls the incoming President forward to take the  oath.  Once the oath has been sworn, the  sash is draped on the right shoulder of the new President. A similar thing is  done with a pin worn by the Vice President. 

The oath of  office, taken both in Nicaragua  and Guatemala,  were similar and interesting. The oath in the U.S. is an affirmative set of statements  related to supporting, defending and obeying the constitution.  The Latin American countries include a stern  warning that if the leader doesn’t meet the expectations of the people, they  will be held accountable by history and the people.

The President’s  speech was 45 minutes long.  He appeared  to put aside his formal speech and spoke without notes.  He passionately laid out his  aspirations.  It will be great if only a  faction of it could be accomplished in four years. I found interesting how openly  he referenced God and made other religious references. 

There were small  nuances worth observing.  Things like who  didn’t stand up to applaud. You could see the political coalition playing out  among the members of Congress sitting behind him.  A two-man band of indigenous Indians played a  squawking sort of tune with a reed instrument and drum as the transition of  power was occurring. It was a symbol of support for indigenous people.  The interaction between various heads of  state was intriguing to watch.  A lot of  Latin American politics was playing out in front of me.

In the evening, inauguration  parties and rallies were held throughout the capital city.  We dropped by a reception at the same  building where I met President Berger the night before.   

Just outside the  building, a crowd of 20,000 or more people waited for the event to start. We  could hear them, but couldn’t see them.   There were some doors which appeared to open toward the crowd, so  Ambassador Derham and I opened them up to see if we could watch the  festivities. The doors lead onto a balcony overlooking the gathering. 

As we walked on  to the balcony, the crowd apparently thought we were the official party walking  out to greet them.  A great collective  shout went up and the crowd began to cheer.   We realized we had unintentionally triggered a response and quietly  withdrew, closing the door behind us.   For just a second, however, I felt like Juan Peron.
 

Day 5 in India (Written Jan. 11)

I remember worrying about polio as a child. Victims were put in an iron lung machine to preserve their lives. Many of those who lived had crippling disabilities.

My mother took me to a school where we stood in a long line to be immunized. It was part of a national immunization campaign. The vaccine was delivered by putting drops in a sugar cube.

Now, 50 years later, the polio virus is gone from the United States because of aggressive public health efforts to eradicate it. However, it has continued to ravage other nations. If it is present anywhere, it is a danger everywhere, so our government, in combination with others, has committed to eradicate it from the earth. Only four countries: Nigeria, Pakistan, Afghanistan and India continue to see cases. India is critical because it has the largest number of cases. As of December, 452 cases were reported in India, which represents 55% of the total 832 cases worldwide.

The primary strategy for eradicating polio is the immunization of every child, but it is a lot more complicated in India than it was my hometown 50 years ago. They have to reach 175 million children, multiple times.

I spent a portion of a day in India learning about the strategy and organization of the effort. It is a daunting challenge. Organizers have developed 1.2 million teams of people who go into every nook and cranny of India, searching house-by-house with the objective of reaching every child.

Neighborhoods are charted with hand-drawn maps. Trained volunteers then wade into broken-down, sometimes scary housing areas. They explain immunization to parents. Many are untrusting and wary. Women seem to be more effective as volunteers because they can enter the homes, which is not culturally appropriate for a man.

Two drops are put in the mouth of each child. A check mark is put on the hand-drawn map and the results are recorded in chalk above the doorway.

Drops are squeezed into the mouths of 25 children from the same bottle. It values efficiency and reach over perfection by accepting some risks as inherent when balanced against the greater good. This is raw public health.

I joined the volunteers in a slum area of New Delhi. The homes are made of homemade bricks, sticks, cardboard, sheet metal or any other material they could get. Most had no doors, just drapes. When the drape was pulled back, enough light would flood into the room to reveal a hut-like atmosphere with mats for beds and crudely made furniture. In some cases, the rooms were three or four feet wide and six feet long. Raw sewage ran in a small ditch that weaved a path through the area.

Children ran about, made curious by these unusual visitors. Mothers wore a quiet dignity that I observed as nearly universal among Indian woman. Nearly all of the women wear long flowing saris that provide a sense of elegance even in poverty. They are such attractive people.

Most of the older children understand what is happening and cooperate. However, the smaller ones have to be held with their head back and their mouth opened by pinching their cheeks together. Understandably, they cry and squirm.

Secretary Leavitt administers polio vaccine to a child in New Delhi

As I held those children in my arms, I was a close witness to the filth they live in. Some had puffy eyes and a smell that follows poverty. They were, however, simply beautiful and I felt gratitude for being able to hold them and deliver a potentially life-preserving gift.

During my time at HHS, I have learned a profound appreciation for those who choose to serve the down-trodden of our nation and the world. Many of them work for the Centers for Disease Control and Prevention, the Indian Health Service or National Institutes of Health. They serve with an easily recognized spirit of goodness. They live significant periods of their lives in conditions far below what they could, while accepting risks and personal hardships. God bless them.

Day 4 in India (Written Jan. 10)

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It seems as if each day of my India trip has taken on a  theme.  The first day, Monday, was spent  understanding our efforts on HIV/AIDS in India.  Tuesday was a tutorial on the generic drug  and vaccine industry in India  and the role they play in providing products for the United States. I also spent time  with non-profits we support in a push against human trafficking.  Wednesday was devoted to a similar study of  the food industry and its connection to the United States. 

Thursday was devoted to meeting with government officials  and doing diplomacy events at a university.   In total, I held meetings with the Ministers of Health, Commerce,  Agriculture, Science and Technology.  In  each of the meetings we discussed our countries’ new strategy on import safety  and the impact it could have on Indian businesses. 

I also met with Dr. Samlee Pilianbangchang, the Regional  Director of the World Health Organization.   We discussed a long list of subjects ranging from HIV/AIDS, Indonesia’s  unwillingness to share samples of influenza cases and intellectual property  disputes.    

Whenever I visit another country, I like to do a diplomacy  event at a university where I can interact with students.  I think university students are a good gauge  of how the United States  is viewed and more importantly the direction of their thinking.  I also hope it is helpful for them to have  interacted directly with a senior official of our government — to find out we  are just people with lives driven by circumstances not completely different  from their own. 

In New Delhi I went to Jamia Millia   Islamia University.  It was a new experience for me.  I had not been on an Islamic campus  before.  The university has about 10,000  students.  About 450 attended mostly science  and medical students and faculty. 

The program started with a reading from the Koran, the  singing of the school song and opening remarks by the Vice Chancellor.  It is my practice to use a hand-held  microphone and stand on the front of the stage so there is nothing between the  students and me. 

I told them I wanted to divide our time together into three  parts.  First, I wanted them to know who  I am and to feel as if they know something about me as a person.  Second, I wanted to make one point that could  stimulate some discussion and give them an opportunity to better understand my  view of the world.  Last, I wanted to  reserve the majority of time for them to ask me questions. 

For 10 minutes or so, I told them about my life.  It included discussion about my parents,  brothers and home in Utah.  I told them about my wife of 34 years and our  five children and three grandchildren.  I  talked about my professional career and how I got into public service.  I went into some detail on the nature of my job  in the United States  government. 

The second part of my presentation was devoted to describing  how I see the world beginning to organize itself into networks.  I used product safety as an example. 

For the final section I invited them to ask me whatever they  wanted. I had been briefed by the embassy that I would likely get some  questions about matters related to Pakistan, Iraq and Afghanistan, so as an  introduction to the Q&A portion I told them there are some subjects on  which I will comment, but I want you to know I am neither an expert nor a  spokesman for the United States on those matters. 

The students interacted with me in a respectful way.  The questions were mostly focused on the  scientific relationships between the U.S.  and India.  Why aren’t Indian doctors recognized in the  U.S?  The price of drugs and intellectual  property protection were raised.   Students asked about the number of people who are uninsured in the United States  as well as matters related to mental health and stem cell research.   

There was one student who  read a statement critical of the United States  and our positions on the war in Iraq.   I told them the war in Iraq was one of those issues that  does not fall into my expertise but I did want them to know what is in the  heart of Americans and specifically President Bush.  I told them war is always awful and that for  centuries afterwards the motives of those involved are questioned and examined  by historians.  This war will be no  different.  However, in my private  conversations with President Bush it has become clear to me that he is most  devoted to the principle that every human being deserves to have liberty and  that no nation can provide another with a better gift than freedom.  Freedom is our goal and we will continue to  pursue that until the people of Iraq  and Afghanistan  can govern themselves in a sustainable democracy. 

In a previous blog I referenced a dinner the Ambassador  hosted at his residence. Two additional comments:  I enjoyed the way the dinner was organized.  There was only one table and it was  round.  So often one goes to dinners like  that and the group is divided into small groups sitting at different  tables.  It means you don’t have any  exposure to many of the people who attend.   As dinner proceeded, the Ambassador asked me to tee up a conversation  with some opening comments.  I recounted  the purpose of my India  trip and posed a series of questions at the end.  The dinner guests then weighed in and we had  a stimulating conversation that nearly everyone participated in. 

The second thing of interest was the embassy.  The United States Embassy in India is large,  spacious and beautifully designed.  The  Ambassador’s home is an image of the Kennedy  Center in Washington, D.C.  It turns out, the embassy was built before  the Kennedy Center and that they were designed by  the same architect.  Jackie Kennedy had  been at the embassy and asked that the same architect do the Kennedy Center  for the Arts.  The Kennedy Center  is the copy, not the other way around.

Day 3 in India (Written Jan. 9)

The Cochin region of India has been the center of the world’s spice trade for millennia. Apparently the soils and climate are perfect and the culture has been defined by the customs and moment and organization it brings.

The port of Cochin is where most of the spices are shipped. Early Wednesday morning our delegation met with port officials and inspected the operation from a boat. It looked like other ports I have seen. They have recently entered into an agreement with Dubai Ports to build a major expansion of the Cochin port. Much of the investment being made to build up India’s infrastructure is coming from private investment referred to as direct foreign investment (DFI). For example they desperately need airports so they have allowed 30 or so private airports to be built. The owners charge leases and landing fees to those using the airports. It generates jobs, and tax revenue but they are not required to use their cash or capital. In the United States we are able to have public construction with bonds.

The balance of the day was devoted to learning about the spice business. I visited Synthite Industrial Chemicals. Many of the businesses are family companies. I’ve found that to be true of many food-related businesses within the United States as well.

It is interesting that they view themselves as a chemical company and not a spice business. The processes they use to produce oils and extracts are similar to those used in large food operations and food processors. For example, they can produce a mustard oil that flavors other materials. French’s Mustard is a composite of materials that spread well, including a plant that is processed to provide the brilliant yellow color and a little dab of their mustard oil. They also create the chemicals used as coloring and fragrances.

They are a huge producer of black pepper. It strikes one when you see the size of their facility and realize it is producing 24 hours a day, just how many people there must be in the world to consume that much black pepper. It takes a lot of shakes and turns of the pepper grinder to use it all. Actually, with pepper they are finding ways to use an oil pepper to produce the same flavor. They just blend it in.

This is an interesting part of the world I knew nothing about. The customers for Synthite and others like them are “flavor houses”-- businesses that engineer the ingredients and processes of making food.

At lunch I met with a group of business owners known as the Spice Board. This is an entity organized by the government to facilitate and promote Indian spices. My sense was, they really get it. They can see the need to get ahead of product safety as a matter of brand protection and market enhancement. They have created a certification process that assures any spice leaving India in a few categories has been certified to a standard. It is a template for how many different industries and countries will handle product safety. If the United States, for example, can become comfortable that the certification of the Spice Board is to be relied upon, then we would treat any product holding their seal in a favorable way in matters related to customs and entry by allowing them easy and fast access into American markets.

The Red Pepper Principle

Our afternoon was occupied by a visit to another spice operation; this one, AVT/McCormick. The factory is surrounded by homes of the most basic form. The winding road into the plant is narrow but paved and so close to many of the homes that it provided an intimate view of the people who lived there. As we drove I was able to see inside yards and homes, even make eye contract with people. I enjoyed the drive.

McCormick has a big market share in the American spice business. They bought into this plant about 10 years ago. The processing is interesting, but I found the relationships between McCormick’s growers and customers the most interesting part of the visit.

Upon arriving I noticed some large burlap bags of red chili peppers. Sewn to each of the bags were yellow cloth tags with messages written on them. I was told the farmers were required to put their names, location the chili peppers came from and the date they were picked on the tag. The McCormick people told me this was a system they had implemented during the previous year as a result of a traceability requirement their customers were making.

The farmers who provide peppers and other crops to McCormick are people with only an acre or two of land. Most are unsophisticated but they are also part of a powerful political constituency in India. Unlike many parts of the world, poor people vote in India and the political officials are extremely sensitive to their desires.

It is highly unlikely that a requirement of traceability would have ever been imposed on the small farmer by the government. However, when customers made it a condition of doing business, the farmers accepted it or started doing business someplace else. Since McCormick is the most reliable partner in the market, almost all adapted. Let’s call it the Red Pepper Principle of Product Safety: Markets, not mandates, will drive improvement in quality.

The small farmer is a unique aspect of India’s economic and social challenge going forward. Like so many emerging economies, significant disparities are developing between urban and rural. While in Vietnam a couple years ago I saw a nation subdivided into plots of less than an acre. Forty-three million farmers worked the land by hand growing their own food and a little extra, which they sold. I asked their Agriculture Minister why more mechanization was not introduced. I understood how the social stability of their nation was linked to the system when he said, “What would those forty three million people do if they didn’t farm.” In India, the government wrestles with the same question except the number is more like 700,000,000.

At Ambassador Mulford’s home my second night in New Delhi, I had dinner with 10 people he had selected for a round-table discussion. Part of the group was a well-respected economist whose clear thinking I immediately admired. In response to a government official’s defense of protectionist policies to preserve the small farmer she said, “What you’re leaving out is they can change.”

Indeed they will change, but likely not because of government policy changes. People will avoid change intuitively and democracies follow. Over time, things will begin to change because of the only democratic force stronger than a self-interested constituency: an efficient market. A global market will require change for survival, and over time some will adapt. The McCormick red pepper farmers are a prime example.

This kind of change takes years. Many small farmers will resist adaptation, living out their lives raising food for themselves and selling the balance for subsistence. Others will be of a nature to accept change and seek greater prosperity. They will begin to join with others so they achieve economies of scale. They will implement new practices that make their crops attractive at higher prices because they are higher quality.

I have an agricultural heritage. My family bought the farm of my grandfather and as his generation died away, we bought their land to achieve the efficiency of scale necessary for survival. Today the collection of land that supported 21 families 50 years ago is farmed by fewer than three full-time workers. However, during the same time other things changed. The next generation of children sought education and earned their living differently than their forefathers. How to navigate such change in a nation with four times the population and one third the land? That is the question facing India in the next half-century.

Day 2 in India (Written Jan. 8)

Tuesday in India, I concentrated on drug safety by traveling to Hyderabad, about an hour flight from Chennai.  My first event was a visit to Dr. Reddy’s, a significant manufacturer of generic drugs for the American market.  I’m told there are nearly 100 facilities in India producing generics.  It is a major industry here and the United States is their primary market. 

The Chairman is Dr. Anji Reddy who 22 years ago began manufacturing active ingredients for other drug companies.  Four years ago, they decided to manufacture generic drugs of their own.  They are also working to get some original molecules approved by FDA.  They built a state-of-the-art plant that has been inspected many times by FDA.  They choose to do the manufacturing in India because the cost structure is so favorable.  They employ nearly a thousand scientists who are paid much less than American scientists. An HHS scientist working with me estimated the average Indian scientist would be paid around $2,000 a month, which puts them in the top social economic range. A comparable American scientist would demand six figures. 

The company feels the combination of circumstances creates a 25 percent or greater cost advantage.  The generic market is by nature a commodity, price-driven market.  I was impressed by the quality of the facility and some of the innovations I saw. This begins a clear pattern of Americans innovating and the Indians producing.  That will change over time, however, because it won’t be long until there is a steady stream of Indian molecular innovations in the FDA pipeline. 

I drove to a village called Thumkunta to talk with a group of non-profits who work with victims of human trafficking.  Nearly all travel is on narrow two-lane roads just overrun by traffic.  Pedestrians, motorbikes, small three-wheel taxis, cows, and large trucks all jockey for position.  There are few rules that seem to define navigation.  Most of the motorbikes have loads of three or more people, rarely with helmets.  Little children routinely sit atop the gas tank or sit on the lap of their mother who sits sidesaddle on the back.  They pass inches (no exaggeration) from the car as our motorcade picks its way through.

Commerce is everywhere.  Small store fronts, garages, small real estate offices, and some unusual ones.  A store front sign with a picture of an arm in a sling stands out.  The sign says: bone setting.

Evidence of emerging economic conditions can be seen.  We passed walled developments being built with small units organized like condominiums.  There were signs advertising home-ownership opportunities.  The eight to 10 percent economic growth of India is real but not uniform.

Once at the meeting with the non-profit leaders working on human trafficking, some discouraging realities set in.  Human beings can be so brutal and cultures so willing to turn their heads to it.  Trafficking in persons takes many forms.  People target young women who are either in serious poverty or being abused at home—or both.  They offer them employment in a glamorous setting and when they get them away, the arrangement turns into a horrifying situation where they are forced into prostitution, begging or other kinds of labor.  It can also be children who are sold by family members into labor.  The stories are simply awful and frightfully common.

Our nation has taken a strong position on trafficking in persons.  We are holding nations accountable for their actions related to it.  We condition much of our foreign assistance, for example, on a nation’s enactment and enforcement of laws prohibiting trafficking.  India needs to do a better job of it.  Much of it is based on long-held cultural values and practices that diminish the role of women generally. As discouraging as it is, I must say how grateful I am that there are people like the non-profit workers I met here and other places around the world who are willing to devote their lives to helping them. 

In the afternoon, we visited Bharat Biotech, a small vaccine manufacturer built by Dr. Krishan Ella and his wife Suchitra.  Krishan is an India scientist who spent many years in the United States. His facilities have been built to American standards and are regularly inspected by FDA.

It’s a great entrepreneurial story of people who sold their home, persuaded a couple of friends to believe in them and developed an industry in India.   While the cost structure here is clearly a major part of their success, it appears to me that their success has also been the ability to solve some problems others didn’t. That has been the foundation of their rise.

Interestingly, his business has another side story.  The first two vaccines he produced were given to him by the U.S. government.  They were available to anybody but no one had seen a way to make a market.  He used his engineering background and a group of Indian scientists who he hired to invent new processes to solve problems that otherwise would have required massive investment. 

It is remarkable how many of the people involved in these sectors have spent careers in the United States.  Most of them were educated in our country and spent a decade or more working in the U.S.

After a courtesy visit with the Chief Minister (equivalent of Governor) of the state Hyderabad is in, we talked about their challenge to implement a health insurance program and the problems of import safety. 

After a two hour flight to Cochen we bedded down for the night.

Chennai, India (Written Jan. 7)

I am in India for the week. My primary mission is to discuss import safety with the leaders of the Indian Government. While I’m here, I will also review our investments in HIV/AIDS, tuberculosis and pandemic preparedness.

Today I’m in Chennai, a city of seven million in India’s south region. This is my first visit to India. The complexity of the place was captured well by the Ambassador to the United States from India, whom I consulted with before I left. He jokingly said, “If you have heard anything about India, it is likely true—someplace.” He referred to the many different cultures. For example, there are 18 official languages spoken. Like China, there are stark differences between urban and rural parts of the country.

The most evident characteristic of India is the density of population. India is about one-third the size of the United States and has four times the population. Put another way, 15 percent of the world’s population lives in India on 2.4 percent of the land mass. Almost a third of the population is under 15 years old, and 70 percent live in one of 550,000 villages. This is one crowded place.

I spent the morning at Tambaram Sanatorium, attached to the Government Hospital of Thoracic Medicine in Chennai. Both CDC and NIH within my department have long-term relationships here. It is a major treatment center for HIV/AIDS. The hospital sees 1,500 patients a day, 33,000 a month and more than 400,000 a year. Being in a HIV/AIDS treatment center is always a moving experience for me.

Generally their patients have been tested some other place, and then come to this hospital to get counseling and a treatment regimen, along with the appropriate drugs. Patients then return about once a month to be checked and get their medicine. The process is similar to what I observed in Africa.

As I walked through the pediatric section, I was surrounded by children and their mothers. I was distributing toys I had brought to cheer them up. Through the crowd, I noticed a woman sitting on a cot. She was thin, dangerously thin, but strikingly beautiful. She must have felt my gaze, because she looked up and engaged me with her eyes. She slowly and deliberately mouthed the words “thank you.” Still surrounded by a press of people, I simply nodded and accepted her expression. We used no words, but communicated deeply. It was not me she addressed, but my country. Her expression sent gratitude to every American. Our compassion had given her hope.

Throughout the day I was with my friend Anbumani Ramadoss, the Indian Minister of Health and Family Welfare. We have known each other for two years now. He is young, charismatic and competent. He is a medical doctor by training, and the son of a prominent regional political party leader. Chennai is his hometown, and he is a popular figure here.

The United States and India have an active agenda of things we already work together on. Vaccines, infectious disease, HIV/AIDS, maternal and child health, vision and medical technology are just a few. Much of our conversation centered on food and drug safety and the Minister’s plans to create an equivalent of the FDA in India. I have offered technical assistance. Dr. Andy Von Eschenbach, Commissioner of the FDA within my department, is with me. Each of us will be putting a team together to work on this, much the same as we did in China. I still need to speak with other Ministers of the Indian Government on this matter.

Our collective teams sat down to review an agenda of items, and then had a formal lunch with about 400 people from the medical community throughout Tamil Nadu state. I directed my remarks mostly to import safety. Actually, I printed off the blog post I wrote on the five lessons I had learned dealing with import safety, and used it as an outline for my speech--an unanticipated side benefit of writing this blog.

The rest of the afternoon was spent visiting Loyola College of Chennai, to observe an HIV/AIDS awareness program called the Red Ribbon Club. They have just launched a curriculum for communicating prevention messages among peer groups of young people. It’s an impressive piece of work. We’re losing the battle when we just treat HIV/AIDS among the infected. We have to be in front of this, and prevent it if we are ever to be hopeful of stopping the epidemic. A lesson from Africa reinforced in India.

I was grateful for a two-and-a-half hour break before dinner with a group of community leaders. The jet lag and a cold I picked up over the holiday were beginning to combine against me. A short nap helped.

I always meet interesting people on these trips. Another I’ll mention today is Dr. Pratap Reddy, M.D. He is a trained cardiologist who worked at the Missouri State Chest Hospital for about 10 years. He returned to India to set up private hospitals. His company, Apollo Hospitals Group, now has 46 hospitals. I want to write more about this later, because one of their hospitals’ trademark characteristics is they make their results public, and post their prices. They have results that rival the best U.S. hospitals, and their costs are a fraction of U.S. prices. Many of their patients are from other countries, part of India’s medical tourism initiative; more on this later.

Import Safety Agreements with the Chinese Government

Under assignment from President Bush, I have devoted considerable time and a lot of HHS resources over the past six months to an Import Safety Working Group. I was chairman of the 12-person group which represented all the relevant parts of the U.S. government.

The working groups concluded that our country has a good system of import safety, but it is inadequate for the future. In September, we laid out a strategic framework for the future. In November, we issued an implementation plan with 50 specific recommendations in 14 different categories.

Throughout the period of our work, Chinese products have been under substantial media scrutiny because of a series of negative incidents involving their pet food, aquaculture products, tooth paste and toys with lead paint. It was evident to both our countries that these events were warning signs that required a policy response.

In the summer of 2007, I began working with Chinese officials to develop binding memorandums of agreement on how we can work together to assure their products meet U.S. standards. I asked Andy von Eschenbach, Commissioner of the FDA, to assemble a technical team. I assigned my Chief of Staff, Rich McKeown, to represent me in the negotiations. Vice Premier Wu Yi of the Chinese government received a similar assignment from President Hu to organize a team.

The work between the Chinese and American negotiating teams spanned six months and involved four different rounds of meetings. They were rigorous and spirited. However, in the end, two agreements were produced. One agreement is on food and animal feed. The second is focused on drugs and medical devices. I believe these two agreements contain a framework which will have a profound impact not just on the importing relationships between the U.S and China, but also on the relationships we have with other nations.

I want to enumerate five of the many important conclusions I have reached during this period.

Lesson 1: The import safety problem is the natural consequence of a maturing of the global marketplace. These issues have been slowly ripening for several years now. It is a direct reflection of the profound growth in the amount of trade between nations. Our systems are not designed for the pressure they are under. We are inventing tools to deal with new problems. Scaling the old way up is an inadequate response.

Lesson 2: Collaboration is necessary within governments as well as between governments. Different countries have different systems of government and different views of import challenges and priorities. Likewise, different parts of governments see import safety with different perspectives. For example, a border protection agent views this as a law enforcement challenge. A public health official sees it as a health problem and, naturally, a trade negotiator wants to know how it will affect commerce.

Lesson 3: Different perspectives, economic systems and regulatory regimes must be bridged by common goals, international standards and interoperable systems. The standardization of cargo containers across the world is a proper metaphor. By adopting standard-sized containers, the shipping community has made it possible for cargo to be handled efficiently in any nation. There is no substitute for the hard, messy work of collaboration in developing them.

Lesson 4: Transparency is trust’s seed. In a global market, speed is life. Anything that slows the flow of goods down, including unnecessary inspections, damages competitiveness. Competitiveness and safety can co-exist only when one knows who to trust. Transparency brings trust; trust brings speed; speed wins in a global market.

Lesson 5: Continuous improvement is necessary. The agreements we signed with the Chinese are frameworks and will require continued work at many layers of government and industry. There is a Chinese saying, “A man who would move a mountain starts by moving small stones.”